Notices. Notice

225,773 words·~1026 min read·/register/2008/06/27/08-1398

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BILLING CODE 6705-01-P FEDERAL COMMUNICATIONS COMMISSION Notice of Public Information Collection(s) Being Reviewed by the Federal Communications Commission, Comments Requested June 23, 2008. SUMMARY: The Federal Communications Commission, as part of its continuing effort to reduce paperwork burdens, invites the general public and other Federal agencies to take this opportunity to

(PRA)of 1995 (PRA), Public Law No. 104-13. An agency may not conduct or sponsor a collection of information unless it displays a currently valid control number. Subject to the PRA, no person shall be subject to any penalty for failing to comply with a collection of information that does not display a valid control number. Comments are requested concerning

(a)whether the proposed collection of information is necessary for the proper performance of the functions of the Commission, including whether the information shall have practical utility;

(b)the accuracy of the Commission's burden estimate;

(c)ways to enhance the quality, utility, and clarity of the information collected; and

(d)ways to minimize the burden of the collection of information on the respondents, including the use of automated collection techniques or other forms of information technology. DATES: Written PRA comments should be submitted on or before August 26, 2008. If you anticipate that you will be submitting comments, but find it difficult to do so within the period of time allowed by this notice, you should advise the contact listed below as soon as possible. ADDRESSES: Interested parties may submit all PRA comments by e-mail or U.S. post mail. To submit your comments by e-mail, send them to *PRA@fcc.gov* and/or *Cathy.Williams@fcc.gov.* To submit your comments by U.S. mail, mark them to the attention of Cathy Williams, Federal Communications Commission, Room 1-C823, 445 12th Street, SW., Washington, DC 20554. FOR FURTHER INFORMATION CONTACT: For additional information about the information collection(s), contact Cathy Williams at

(202)418-2918 or send an e-mail to *PRA@fcc.gov* and/or *Cathy.Williams@fcc.gov.* SUPPLEMENTARY INFORMATION: *OMB Control Number:* 3060-0061. *Title:* Annual Report of Cable Television Systems. *Form Number:* FCC Form 325. *Type of Review:* Revision of a currently approved collection. *Respondents:* Business and other for-profit. *Number of Respondents and Responses:* 1,200 respondents; 1,200 responses. *Estimated Time per Response:* 2.166 hours. *Frequency of Response:* Annual reporting requirement. *Obligation to Respond:* Required to obtain or retain benefits. The statutory authority for this information collection is contained in Sections 4(i), 601 and 602 of the Commissions Act of 1934, as amended. *Total Annual Burden:* 2,599 hours. *Total Annual Costs:* None. *Privacy Impact Assessment:* No impact(s). *Nature and Extent of Confidentiality:* There is no need for confidentiality. *Needs and Uses:* The Commission made revisions/refinements to FCC Form 325 to accommodate systems using technologies other than coaxial cable (Section II,4). Previously, the number of these filers was very small. Now the portion of the sample is becoming significant. These revisions/refinements to Form 325 will allow the form to be filed electronically by these filers, avoiding a significant cost. Refinements are also made to the form to eliminate instances where potential subscribers are double counted (Section II,2). This occurs where a competing system enters the market and reports as such. These refinements impose no significant new requirement and will reduce aggregate filing costs by simplifying filing for overbuilders and permitting electronic filing for the increasing number of competing service providers. The FCC uses Form 325 “Annual Report of Cable Television” to solicit basic operational information from a sample of cable systems nationwide, including: the operator's name and address; system-wide capacity and frequency information; channel usage; and number of subscribers. Operators of every operational cable television system are required to complete the form to verify, correct and/or furnish the Commission with the most current information on their respective cable systems. Federal Communications Commission. Marlene H. Dortch, Secretary. [FR Doc. E8-14640 Filed 6-26-08; 8:45 am] BILLING CODE 6712-01-P FEDERAL TRADE COMMISSION Agency Information Collection Activities; Submission for OMB Review; Comment Request; Extension AGENCY: Federal Trade Commission (“Commission” or “FTC”). ACTION: Notice. SUMMARY: The information collection requirements described below will be submitted to the Office of Management and Budget (“OMB”) for review, as required by the Paperwork Reduction Act (“PRA”). The FTC is seeking public comments on its proposal to extend through July 31, 2011, the current PRA clearance for information collection requirements contained in the Commission’s Gramm-Leach-Bliley Financial Privacy Rule (“GLB Privacy Rule” or “Rule”). The current clearance expires on July 31, 2008. DATES: Comments must be submitted on or before July 28, 2008. ADDRESSES: Interested parties are invited to submit written comments. Comments should refer to “Paperwork Comment: FTC File No. P085405” to facilitate the organization of comments. A comment filed in paper form should include this reference both in the text and on the envelope and should be mailed or delivered to the following address: Federal Trade Commission, Room H-135 (Annex J), 600 Pennsylvania Ave., N.W., Washington, D.C. 20580. The Commission is requesting that any comment filed in paper form be sent by courier or overnight service, if possible because U.S. postal mail in the Washington area and at the FTC is subject to delay due to heightened security precautions. Moreover, because paper mail in the Washington area and at the FTC is subject to delay, please consider submitting your comments in electronic form, as prescribed below. If, however, the comment contains any material for which confidential treatment is requested, it must be filed in paper form, and the first page of the document must be clearly labeled “Confidential.” 1 1 Commission Rule 4.2(d), 16 CFR 4.2(d). The comment must be accompanied by an explicit request for confidential treatment, including the factual and legal basis for the request, and must identify the specific portions of the comment to be withheld from the public record. The request will be granted or denied by the Commission's General Counsel, consistent with applicable law and the public interest. *See* Commission Rule 4.9(c), 16 CFR 4.9(c). Comments filed in electronic form should be submitted by following the instructions on the web-based form at ( *https://secure.commentworks.com/ftc-glbprivacyrulepra* ) and following the instructions on the web-based form. To ensure that the Commission considers an electronic comment, you must file it on the web-based form at the ( *https://secure.commentworks.com/ftc-glbprivacyrulepra* ) weblink. If this notice appears at *www.regulations.gov* , you may also file an electronic comment through that website. The Commission will consider all comments that *www.regulations.gov* forwards to it. All comments should additionally be submitted to: Office of Management and Budget, Attention: Desk Officer for the Federal Trade Commission. Comments should be submitted via facsimile to

(202)395-6974 because U.S. Postal Mail is subject to lengthy delays due to heightened security precautions. The FTC Act and other laws the Commission administers permit the collection of public comments to consider and use in this proceeding as appropriate. All timely and responsive public comments will be considered by the Commission and will be available to the public on the FTC website, to the extent practicable, at *www.ftc.gov* . As a matter of discretion, the FTC makes every effort to remove home contact information for individuals from the public comments it receives before placing those comments on the FTC website. More information, including routine uses permitted by the Privacy Act, may be found in the FTC's privacy policy at ( *http://www.ftc.gov/ftc/privacy.shtm* ). FOR FURTHER INFORMATION CONTACT: Kellie Cosgrove Riley, Senior Attorney, Division of Privacy and Identity Protection, Bureau of Consumer Protection,

(202)326-2252, Federal Trade Commission, 600 Pennsylvania Avenue, N.W., Washington, D.C. 20580. SUPPLEMENTARY INFORMATION: On April 2, 2008, the FTC sought comment on the information collection requirements associated with the GLB Privacy Rule, 16 CFR Part 313 (OMB Control Number 3084-0121). *See* 73 FR 17980. No comments were received. Pursuant to the OMB regulations, 5 CFR Part 1320, that implement the PRA, 44 U.S.C. 3501-3521, the FTC is providing this second opportunity for public comment while seeking OMB approval to extend the existing PRA clearance for the Rule. All comments should be filed as prescribed in the ADDRESSES section above, and must be received on or before July 28, 2008. The GLB Privacy Rule is designed to ensure that customers and consumers, subject to certain exceptions, will have access to the privacy policies of the financial institutions with which they conduct business. As mandated by the Gramm-Leach-Bliley Act, 15 U.S.C. 6801-6809, the Rule requires financial institutions to disclose to consumers:

(1)initial notice of the financial institution’s privacy policy when establishing a customer relationship with a consumer and/or before sharing a consumer’s non-public personal information with certain nonaffiliated third parties;

(2)notice of the consumer’s right to opt out of information sharing with such parties;

(3)annual notice of the institution’s privacy policy to any continuing customer; and

(4)notice of changes in the institution’s practices on information sharing. These requirements are subject to the PRA. The Rule does not require recordkeeping. **Estimated annual hours burden:** As noted in the original burden estimate for the GLB Privacy Rule, determining the paperwork burden of the Rule’s disclosure requirements is very difficult because of the highly diverse group of affected entities, consisting of financial institutions not regulated by a federal financial regulatory agency. *See* 15 U.S.C. 6805 (committing to the Commission's jurisdiction entities that are not specifically subject to another agency’s jurisdiction). The burden estimates represent the FTC staff’s best assessment, based on its knowledge and expertise relating to the financial institutions subject to the Commission's jurisdiction under this law. To derive these estimates, staff considered the wide variations in covered entities. In some instances, covered entities may make the required disclosures in the ordinary course of business, apart from the GLB Privacy Rule. In addition, some entities may use highly automated means to provide the required disclosures, while others may rely on methods requiring more manual effort. The burden estimates shown below include the time that may be necessary to train staff to comply with the regulations. These figures are averages based on staff’s best estimate of the burden incurred over the broad spectrum of covered entities. Staff retains its prior estimate of the number of entities each year that will address the GLB Privacy Rule for the first time (5,000) and its estimate of established entities already familiar with the Rule (100,000). While the number of established entities familiar with the Rule would theoretically increase each year with the addition of new entrants, staff retains its previous estimate of established entities given that a number of the established entities will close in any given year, and also given the difficulty of establishing a more precise estimate. Staff’s burden estimates for new entrants and established entities are detailed in the charts below. Start-up hours and labor costs for new entrants: *Event* *Hourly wage and labor category** *Hours per* *Respondent* *Approx. Number of Respondents* *Approx. Total Annual Hrs.* *Approx. Total Labor Costs* Reviewing internal policies and developing GLBA-implementing instructions** $31.66 managerial/professional 20 5,000 100,000 $3,166,000 Creating disclosure document or electronic disclosure (including initial, annual, and opt out disclosures) $14.71 clerical 5 5,000 25,000 $367,750 $32.82 professional/technical 10 50,000 $1,641,000 Disseminating initial disclosure (including opt out notices) $14.71 clerical 15 5,000 75,000 $1,103,250 $32.82 professional/technical 10 50,000 $1,641,000 Total 300,000 $7,919,000 * Staff calculated labor costs by applying appropriate hourly cost figures to burden hours. The hourly rates used were based on mean wages for managerial/professional time ( *e.g.* , compliance evaluation and/or planning), professional/technical time ( *e.g.* , designing and producing notices, reviewing and updating information systems), and clerical time ( *e.g.* , reproduction tasks, filing, and, where applicable to the given event, typing or mailing). *See* BLS National Compensation Survey, June 2006, Table 1, available at *http://www.bls.gov/ncs/ocs/sp/ncbl0910.pdf* (Management, professional, and related; office and administrative support) and BLS Occupational Employment and Wages 2006,Table 2, available at *http://www.bls.gov/news.release/pdf/ocwage.pdf* (professional, scientific, and technical services - business and financial operations). Labor cost totals reflect solely that of the commercial entities affected. Staff assumes that the time required of consumers to respond affirmatively to respondents’ opt-out programs (be it manually or electronically) would be minimal. ** Reviewing instructions includes all efforts performed by or for the respondent to: determine whether and to what extent the respondent is covered by an agency collection of information, understand the nature of the request, and determine the appropriate response (including the creation and dissemination of document and/or electronic disclosures). Burden hours and costs for established entities: Burden for established entities already familiar with the Rule predictably would be less than for start-up entities because start-up costs, such as crafting a privacy policy, are generally one-time costs and have already been incurred. Staff’s best estimate of the average burden for these entities is as follows: *Event* *Hourly wage and labor category** *Hours per* *Respondent* *Approx. Number of Respondents*** *Approx. Total Annual Hours* *Approx. Total Labor Costs* Reviewing GLBA-implementing policies and practices $31.66 managerial/professional 4 70,000 280,000 $8,864,800 Disseminating annual disclosure $14.71 clerical 15 70,000 1,050,000 $15,445,500 $32.82 professional/technical 5 350,000 $11,487,000 Changes to privacy policies and related disclosures $14.71 clerical 15 1,000 15,000 $220,650 $32.82 professional/technical 5 5,000 $164,100 Total 1,700,000 $36,182,050 * Staff calculated labor costs by applying appropriate hourly cost figures to burden hours; labor cost totals reflect solely that of the commercial entities affected. The hourly rates used were based on mean wages for managerial/professional time ( *e.g.* , compliance evaluation and/or planning), professional/technical time ( *e.g.* , designing and producing notices, reviewing and updating information systems), and clerical time ( *e.g.* , reproduction tasks, filing, and, where applicable to the given event, typing or mailing). *See* BLS National Compensation Survey, June 2006, Table 1, available at *http://www.bls.gov/ncs/ocs/sp/ncbl0910.pdf* (Management, professional, and related; office and administrative support) and BLS Occupational Employment and Wages 2006,Table 2, available at *http://www.bls.gov/news.release/pdf/ocwage.pdf* (professional, scientific, and technical services - business and financial operations). Consumers have a continuing right to opt-out, as well as a right to revoke their opt-out at any time. When a respondent changes its information sharing practices, consumers are again given the opportunity to opt-out. Again, staff assumes that the time required of consumers to respond affirmatively to respondents’ opt-out programs (be it manually or electronically) would be minimal. ** The estimate of respondents is based on the following assumptions:

(1)100,000 respondents, approximately 70% of whom maintain customer relationships exceeding one year,

(2)no more than 1% (1,000) of whom make additional changes to privacy policies at any time other than the occasion of the annual notice; and

(3)such changes will occur no more often than once per year. As calculated above, the total annual PRA burden hours and labor costs for all affected entities in a given year would be 2,000,000 hours and $44,101,000, respectively. **Estimated Capital/Other Non-Labor Costs Burden:** Staff believes that capital or other non-labor costs associated with the document requests are minimal. Covered entities will already be equipped to provide written notices ( *e.g.* , computers with word processing programs, typewriters, copying machines, mailing capabilities). Most likely, only entities that already have on-line capabilities will offer consumers the choice to receive notices via electronic format. As such, these entities will already be equipped with the computer equipment and software necessary to disseminate the required disclosures via electronic means. David C. Shonka, Acting General Counsel. [FR Doc. E8-14621 Filed 6-26-08: 8:45 am] [BILLING CODE: 6750-01-S] DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention [30Day-08-0488] Agency Forms Undergoing Paperwork Reduction Act Review The Centers for Disease Control and Prevention

(CDC)publishes a list of information collection requests under review by the Office of Management and Budget

(OMB)in compliance with the Paperwork Reduction Act (44 U.S.C. Chapter 35). To request a copy of these requests, call the CDC Reports Clearance Officer at

(404)639-5960 or send an e-mail to *omb@cdc.gov.* Send written comments to CDC Desk Officer, Office of Management and Budget, Washington, DC or by fax to

(202)395-6974. Written comments should be received within 30 days of this notice. Proposed Project Restriction on Travel of Persons (OMB Control No. 0920-0488)—Reinstatement without Change—National Center for Preparedness, Detection, and Control of Infectious Diseases (NCPDCID), Centers for Disease Control and Prevention (CDC). Background and Brief Description The Centers for Disease Control and Prevention is requesting OMB approval to reinstate without change the information collection request, Restriction on Travel of Persons (OMB Control No. 0920-0488). This information collection request expired on March 31, 2007. CDC is authorized to collect this information under 42 CFR 70.5 (certain communicable diseases; special requirements). This regulation requires that any person who is in the communicable period for cholera, plague, smallpox, typhus, or yellow fever or having been exposed to any such disease is in the incubation period thereof, to apply for and receive a permit from the Surgeon General or his authorized representative in order to travel from one State or possession to another. Control of disease transmission within the States is considered to be the province of State and local health authorities, with Federal assistance being sought by those authorities on a cooperative basis without application of Federal regulations. The regulations in 42 part 70 were developed to facilitate Federal action in the event of large outbreaks requiring a coordinated effort involving several States, or in the event of inadequate local control. While it is not known whether, or to what extent situations may arise in which these regulations would be invoked, contingency planning for domestic emergency preparedness is now commonplace. Should these situations arise, CDC will use the reporting and recordkeeping requirements contained in the regulations to carry out quarantine responsibilities as required by law. The only cost to respondents is their time to submit the application materials. The estimated annualized burden for this data collection is 3,600 hours. Estimated Annualized Burden Hours Regulation Respondent No. of respondents No. of responses per respondent Average burden per response (in hours) 42 CFR 70.3 Application to the State of Destination for a permit Traveler 2,000 1 15/60 Attending physician 2,000 1 15/60 42 CFR 70.3 Copy of material submitted by applicant and permit issued by State health authority State health authority 8 250 6/60 42 CFR 70.4 Report by the master of a vessel or person in charge of conveyance of the incidence of a communicable disease occurring while in interstate travel Master of a vessel or person in charge of conveyance 1,500 1 15/60 42 CFR 70.4 Copy of material submitted or State or local health authority under this provision State health authority 20 75 6/60 42 CFR 70.5 Application for a permit to move from State to State while in the communicable period Traveler 3,750 1 15/60 Attending physician 3,750 1 15/60 Dated: June 20, 2008. Maryam I. Daneshvar, Reports Clearance Officer, Centers for Disease Control and Prevention. [FR Doc. E8-14589 Filed 6-26-08; 8:45 am] BILLING CODE 4163-18-P DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention Disease, Disability, and Injury Prevention and Control Special Emphasis Panel (SEP): Elimination of Health Disparities Through Translation Research (Panel C), Funding Opportunity Announcement (FOA), CD08-001 In accordance with Section 10(a)(2) of the Federal Advisory Committee Act (Pub. L. 92-463), the Centers for Disease Control and Prevention

(CDC)announces the aforementioned meeting: *Time and Date:* 10 a.m.-5 p.m., July 16, 2008 (Closed). *Place:* Teleconference. *Status:* The meeting will be closed to the public in accordance with provisions set forth in Section 552b(c)(4) and (6), Title 5 U.S.C., and the Determination of the Director, Management Analysis and Services Office, CDC, pursuant to Public Law 92-463. *Matters To Be Discussed:* The meeting will include the review, discussion, and evaluation of “Elimination of Health Disparities through Translation Research (Panel C), FOA CD08-001.” *Contact Person for More Information:* Susan B. Stanton, D.D.S., Scientific Review Administrator, CDC, 1600 Clifton Road, NE., Mailstop D72, Atlanta, GA 30333, Telephone

(404)639-4640. The Director, Management Analysis and Services Office, has been delegated the authority to sign **Federal Register** notices pertaining to announcements of meetings and other committee management activities, for both CDC and the Agency for Toxic Substances and Disease Registry. Dated: June 20, 2008. Elaine L. Baker, Director, Management Analysis and Services Office, Centers for Disease Control and Prevention. [FR Doc. E8-14580 Filed 6-26-08; 8:45 am] BILLING CODE 4163-18-P DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention Disease, Disability, and Injury Prevention and Control Special Emphasis Panel (SEP): Elimination of Health Disparities through Translation Research (Panel B), Funding Opportunity Announcement (FOA), CD08-001 In accordance with Section 10(a)(2) of the Federal Advisory Committee Act (Pub. L. 92-463), the Centers for Disease Control and Prevention

(CDC)announces the aforementioned meeting: *Time and Date:* 10 a.m.-5 p.m., July 15, 2008 (Closed). *Place:* Teleconference. *Status:* The meeting will be closed to the public in accordance with provisions set forth in Section 552b(c)

(4)and (6), Title 5 U.S.C., and the Determination of the Director, Management Analysis and Services Office, CDC, pursuant to Public Law 92-463. *Matters To Be Discussed:* The meeting will include the review, discussion, and evaluation of “Elimination of Health Disparities through Translation Research (Panel B), FOA CD08-001.” *Contact Person for More Information:* Susan B. Stanton, D.D.S., Scientific Review Administrator, CDC, 1600 Clifton Road, NE., Mailstop D72, Atlanta, GA 30333, Telephone

(404)639-4640. The Director, Management Analysis and Services Office, has been delegated the authority to sign **Federal Register** notices pertaining to announcements of meetings and other committee management activities, for both CDC and the Agency for Toxic Substances and Disease Registry. Dated: June 20, 2008. Elaine L. Baker, Director, Management Analysis and Services Office, Centers for Disease Control and Prevention. [FR Doc. E8-14587 Filed 6-26-08; 8:45 am] BILLING CODE 4163-18-P DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Medicare and Medicaid Services [CMS-2898-PN] Medicare and Medicaid Programs; The Joint Commission for Continued Deeming Authority for Ambulatory Surgical Centers AGENCY: Centers for Medicare and Medicaid Services, HHS. ACTION: Proposed notice. SUMMARY: This proposed notice acknowledges the receipt of a deeming application from the Joint Commission for continued recognition as a national accrediting organization for ambulatory surgical centers

(ASCs)that wish to participate in the Medicare or Medicaid programs. Section 1865(b)(3)(A) of the Social Security Act requires that within 60 days of receipt of an organization's complete application, we publish a notice that identifies the national accrediting body making the request, describes the nature of the request, and provides at least a 30-day public comment period. DATES: To be assured consideration, comments must be received at one of the addresses provided below, no later than 5 p.m. e.s.t. on July 27, 2008. ADDRESSES: In commenting, please refer to file code CMS-2898-PN. Because of staff and resource limitations, we cannot accept comments by facsimile

(FAX)transmission. You may submit comments in one of four ways (no duplicates, please): 1. *Electronically* . You may submit electronic comments on this regulation to *http://www.regulations.gov.* Follow the instructions for “Comment or Submission” and enter the file code to find the document accepting comments. 2. *By regular mail* . You may mail written comments (one original and two copies) to the following address ONLY: Centers for Medicare & Medicaid Services, Department of Health and Human Services, Attention: CMS-2898-PN, P.O. Box 8013, Baltimore, MD 21244-__. Please allow sufficient time for mailed comments to be received before the close of the comment period. 3. *By express or overnight mail* . You may send written comments (one original and two copies) to the following address ONLY: Centers for Medicare & Medicaid Services, Department of Health and Human Services, Attention: CMS-2898-PN, Mail Stop C4-26-05, 7500 Security Boulevard, Baltimore, MD 21244-1850. 4. *By hand or courier* . If you prefer, you may deliver (by hand or courier) your written comments (one original and two copies) before the close of the comment period to either of the following addresses: a. Room 445-G, Hubert H. Humphrey Building, 200 Independence Avenue, SW., Washington, DC 20201. (Because access to the interior of the Hubert H. Humphrey

(HHH)Building is not readily available to persons without Federal Government identification, commenters are encouraged to leave their comments in the CMS drop slots located in the main lobby of the building. A stamp-in clock is available for persons wishing to retain a proof of filing by stamping in and retaining an extra copy of the comments being filed.) b. 7500 Security Boulevard, Baltimore, MD 21244-1850. If you intend to deliver your comments to the Baltimore address, please call telephone number

(410)786-9994 in advance to schedule your arrival with one of our staff members. Comments mailed to the addresses indicated as appropriate for hand or courier delivery may be delayed and received after the comment period. For information on viewing public comments, see the beginning of the SUPPLEMENTARY INFORMATION section. FOR FURTHER INFORMATION CONTACT: Laura Weber,

(410)786-0227, Patricia Chmielewski,

(410)786-6899. SUPPLEMENTARY INFORMATION: *Inspection of Public Comments:* All comments received before the close of the comment period are available for viewing by the public, including any personally identifiable or confidential business information that is included in a comment. We post all comments received before the close of the comment period on the following Web site as soon as possible after they have been received: *http://www.regulations.gov.* Follow the search instructions on that Web site to view public comments. Comments received timely will also be available for public inspection as they are received, generally beginning approximately 3 weeks after publication of a document, at the headquarters of the Centers for Medicare & Medicaid Services, 7500 Security Boulevard, Baltimore, Maryland 21244, Monday through Friday of each week from 8:30 a.m. to 4 p.m. To schedule an appointment to view public comments, phone 1-800-743-3951. I. Background Under the Medicare program, eligible beneficiaries may receive covered services from an ambulatory surgical center

(ASC)provided certain requirements are met. Section 1832(a)(2)(F)(i) of the Social Security Act (the Act) authorizes the Secretary to establish distinct criteria for facilities seeking designation as an ASC. Regulations concerning provider agreements are at 42 CFR Part 489 and those pertaining to activities relating to the survey and certification of facilities are at Part 488. Part 416 specifies the conditions that an ASC must meet in order to participate in the Medicare program, the scope of covered services and the conditions for Medicare payment for ASCs. Generally, in order to enter into an agreement with the Medicare program, an ASC must first be certified by a State survey agency as complying with the conditions or requirements set forth in Part 416. Thereafter, the ASC is subject to regular surveys by a State survey agency to determine whether it continues to meet these requirements. There is an alternative, however, to surveys by State agencies. Section 1865(b)(1) of the Act provides that, if an ASC demonstrates through accreditation by an approved national accrediting organization that all applicable Medicare conditions are met or exceeded, we will deem those ASCs as having met the requirements. Accreditation by an accrediting organization is voluntary and is not required for Medicare participation. If an accrediting organization is recognized by the Secretary as having standards for accreditation that meet or exceed Medicare requirements, any provider entity accredited by the national accrediting body's approved program would be deemed to meet the Medicare conditions. A national accrediting organization applying for deeming authority under Part 488, subpart A must provide us with reasonable assurance that the accrediting organization requires the accredited provider entities to meet requirements that are at least as stringent as the Medicare conditions. Our regulations concerning the reapproval of accrediting organizations are set forth at § 488.4 and § 488.8(d)(3). Section 488.8(d)(3) requires accrediting organizations to reapply for continued deeming authority every 6 years or sooner as determined by us. The Joint Commission's term of approval as a recognized accreditation program for ASCs expires December 20, 2008. II. Approval of Deeming Organizations Section 1865(b)(2) of the Act and § 488.8(a) of the regulations require that our findings concerning review and reapproval of a national accrediting organization's requirements consider, among other factors, the applying accrediting organization's: requirements for accreditation; survey procedures; resources for conducting required surveys; capacity to furnish information for use in enforcement activities; monitoring procedures for provider entities found not in compliance with the conditions or requirements; and ability to provide us with the necessary data for validation. Section 1865(b)(3)(A) of the Act further requires that we publish, within 60 days of receipt of an organization's complete application, a notice identifying the national accrediting body making the request, describing the nature of the request, and providing at least a 30-day public comment period. We have 210 days from the receipt of a complete application to publish notice of approval or denial of the application. The purpose of this proposed notice is to inform the public of the Joint Commission's request for continued deeming authority for ASCs. This notice also solicits public comment on whether the Joint Commission's requirements meet or exceed the Medicare conditions for coverage for ASCs. III. Evaluation of Deeming Authority Request The Joint Commission submitted all the necessary materials to enable us to make a determination concerning its request for reapproval as a deeming organization for ASCs. This application was determined to be complete on May 2, 2008. Under section 1865(b)(2) of the Act and § 488.8 (Federal review of accrediting organizations), our review and evaluation of the Joint Commission will be conducted in accordance with, but not necessarily limited to, the following factors: • The equivalency of the Joint Commission's standards for an ASC as compared with CMS' ASC conditions for coverage. • The Joint Commission's survey process to determine the following: ++ The composition of the survey team, surveyor qualifications, and the ability of the organization to provide continuing surveyor training. ++ The comparability of the Joint Commission's processes to those of State agencies, including survey frequency, and the ability to investigate and respond appropriately to complaints against accredited facilities. ++ The Joint Commission's processes and procedures for monitoring ASCs found out of compliance with the Joint Commission's program requirements. These monitoring procedures are used only when the Joint Commission identifies noncompliance. If noncompliance is identified through validation reviews or complaint surveys, the State survey agency monitors corrections as specified at § 488.7(d). ++ The Joint Commission's capacity to report deficiencies to the surveyed facilities and respond to the facility's plan of correction in a timely manner. ++ The Joint Commission's capacity to provide us with electronic data in ASCII comparable code, and reports necessary for effective validation and assessment of the organization's survey process. ++ The adequacy of the Joint Commission's staff and other resources, and its financial viability. ++ The Joint Commission's capacity to adequately fund required surveys. ++ The Joint Commission's policies with respect to whether surveys are announced or unannounced, to assure that surveys are unannounced. ++ The Joint Commission's agreement to provide us with a copy of the most current accreditation survey together with any other information related to the survey as we may require (including corrective action plans). IV. Response to Public Comments and Notice Upon Completion of Evaluation Because of the large number of public comments we normally receive on **Federal Register** documents, we are not able to acknowledge or respond to them individually. We will consider all comments we receive by the date and time specified in the DATES section of this preamble, and, when we proceed with a subsequent document, we will respond to the comments in the preamble to that document. Upon completion of our evaluation, including evaluation of comments received as a result of this notice, we will publish a final notice in the **Federal Register** announcing the result of our evaluation. V. Collection of Information Requirements This document does not impose information collection and recordkeeping requirements. Consequently, it need not be reviewed by the Office of Management and Budget under the authority of the Paperwork Reduction Act of 1995 (44 U.S.C. 35 *et seq.* ). VI. Regulatory Impact Statement In accordance with the provisions of Executive Order 12866 (September 1993, Regulatory Planning and Review, the Regulatory Flexibility Act

(RFA)(September 19, 1980, Pub. L. 96-354), the Office of Management and Budget did not review this proposed notice. In accordance with Executive Order 13132, we have determined that this proposed notice would not have a significant effect on the rights of States, local or tribal governments. Authority: Section 1865 of the Social Security Act (42 U.S.C. 1395bb) (Catalog of Federal Domestic Assistance Program No. 93.778, Medical Assistance Program; No. 93.773 Medicare—Hospital Insurance Program; and No. 93.774, Medicare—Supplementary Medical Insurance Program) Dated: June 10, 2008. Kerry Weems, Acting Administrator, Centers for Medicare & Medicaid Services. [FR Doc. E8-14679 Filed 6-26-08; 8:45 am] BILLING CODE 4120-01-P DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Medicare and Medicaid Services [CMS-2897-PN] Medicare and Medicaid Programs; Application by the Accreditation Association for Ambulatory Health Care for Continued Deeming Authority for Ambulatory Surgical Centers AGENCY: Centers for Medicare and Medicaid Services, HHS. ACTION: Proposed notice. SUMMARY: This proposed notice acknowledges the receipt of a deeming application from the Accreditation Association for Ambulatory Health Care (AAAHC) for continued recognition as a national accrediting organization for ambulatory surgical centers

(ASCs)that wish to participate in the Medicare or Medicaid programs. Section 1865(b)(3)(A) of the Social Security Act requires that within 60 days of receipt of an organization's complete application, we publish a notice that identifies the national accrediting body making the request, describes the nature of the request, and provides at least a 30-day public comment period. DATES: To be assured consideration, comments must be received at one of the addresses provided below, no later than 5 p.m. e.s.t. on July 27, 2008. ADDRESSES: In commenting, please refer to file code CMS-2897-PN. Because of staff and resource limitations, we cannot accept comments by facsimile

(FAX)transmission. You may submit comments in one of four ways (no duplicates, please): 1. Electronically. You may submit electronic comments on this regulation to *http://www.regulations.gov.* Follow the instructions for “Comment or Submission” and enter the file code to find the document accepting comments. 2. *By regular mail.* You may mail written comments (one original and two copies) to the following address ONLY: Centers for Medicare & Medicaid Services, Department of Health and Human Services, Attention: CMS-2897-PN, P.O. Box 8013, Baltimore, MD 21244__. Please allow sufficient time for mailed comments to be received before the close of the comment period. 3. *By express or overnight mail.* You may send written comments (one original and two copies) to the following address ONLY: Centers for Medicare & Medicaid Services, Department of Health and Human Services, Attention: CMS-2897-PN, Mail Stop C4-26-05, 7500 Security Boulevard, Baltimore, MD 21244-1850. 4. *By hand or courier.* If you prefer, you may deliver (by hand or courier) your written comments (one original and two copies) before the close of the comment period to either of the following addresses: a. Room 445-G, Hubert H. Humphrey Building, 200 Independence Avenue, SW., Washington, DC 20201 (Because access to the interior of the Hubert H. Humphrey

(410)786-8648, Patricia Chmielewski,

(410)786-6899 SUPPLEMENTARY INFORMATION: *Inspection of Public Comments:* All comments received before the close of the comment period are available for viewing by the public, including any personally identifiable or confidential business information that is included in a comment. We post all comments received before the close of the comment period on the following Web site as soon as possible after they have been received: *http://www.regulations.gov.* Follow the search instructions on that Web site to view public comments. Comments received timely will also be available for public inspection as they are received, generally beginning approximately 3 weeks after publication of a document, at the headquarters of the Centers for Medicare & Medicaid Services, 7500 Security Boulevard, Baltimore, Maryland 21244, Monday through Friday of each week from 8:30 a.m. to 4 p.m. To schedule an appointment to view public comments, phone 1-800-743-3951. I. Background Under the Medicare program, eligible beneficiaries may receive covered services from an ambulatory surgical center

(ASC)provided certain requirements are met. Section 1832(a)(2)(F)(i) of the Social Security Act (the Act) authorizes the Secretary to establish distinct criteria for facilities seeking designation as an ASC. Regulations concerning provider agreements are at 42 CFR part 489 and those pertaining to activities relating to the survey and certification of facilities are at part 488. Part 416 specifies the conditions that an ASC must meet in order to participate in the Medicare program, the scope of covered services and the conditions for Medicare payment for ASCs. Generally, in order to enter into an agreement with the Medicare program, an ASC must first be certified by a State survey agency as complying with the conditions or requirements set forth in part 416. Thereafter, the ASC is subject to regular surveys by a State survey agency to determine whether it continues to meet these requirements. There is an alternative to surveys by State agencies, which is accreditation. Section 1865(b)(1) of the Act provides that, if an ASC demonstrates through accreditation by an approved national accrediting organization that all applicable Medicare conditions are met or exceeded, we will deem those ASCs as having met the requirements. Accreditation by an accrediting organization is voluntary and is not required for Medicare participation. If an accrediting organization is recognized by the Secretary as having standards for accreditation that meet or exceed Medicare requirements, any provider entity accredited by the national accrediting body's approved program would be deemed to meet the Medicare conditions. A national accrediting organization applying for deeming authority under part 488, subpart A must provide us with reasonable assurance that the accrediting organization requires the accredited provider entities to meet requirements that are at least as stringent as the Medicare conditions. Our regulations concerning the reapproval of accrediting organizations are set forth at § 488.4 and § 488.8(d)(3). Section 488.8(d)(3) requires accrediting organizations to reapply for continued deeming authority every 6 years or sooner as determined by us. AAAHC's term of approval as a recognized accreditation program for ASCs expires December 20, 2008. II. Approval of Deeming Organizations Section 1865(b)(2) of the Act and § 488.8(a) of the regulations require that our findings concerning review and reapproval of a national accrediting organization's requirements consider, among other factors, the applying accrediting organization's: Requirements for accreditation; survey procedures; resources for conducting required surveys; capacity to furnish information for use in enforcement activities; monitoring procedures for provider entities found not in compliance with the conditions or requirements; and ability to provide us with the necessary data for validation. Section 1865(b)(3)(A) of the Act further requires that we publish, within 60 days of receipt of an organization's complete application, a notice identifying the national accrediting body making the request, describing the nature of the request, and providing at least a 30-day public comment period. We have 210 days from the receipt of a complete application to publish notice of approval or denial of the application. The purpose of this proposed notice is to inform the public of AAAHC's request for continued deeming authority for ASCs. This notice also solicits public comment on whether AAAHC's requirements meet or exceed the Medicare conditions for coverage for ASCs. III. Evaluation of Deeming Authority Request AAAHC submitted all the necessary materials to enable us to make a determination concerning its request for reapproval as a deeming organization for ASCs. This application was determined to be complete on May 2, 2008. Under section 1865(b)(2) of the Act and § 488.8 (Federal review of accrediting organizations), our review and evaluation of AAAHC will be conducted in accordance with, but not necessarily limited to, the following factors: • The equivalency of AAAHC's standards for an ASC as compared with CMS' ASC conditions for coverage. • AAAHC's survey process to determine the following: ++ The composition of the survey team, surveyor qualifications, and the ability of the organization to provide continuing surveyor training. ++ The comparability of AAAHC's processes to those of State agencies, including survey frequency, and the ability to investigate and respond appropriately to complaints against accredited facilities. ++ AAAHC's processes and procedures for monitoring ASCs found out of compliance with AAAHC's program requirements. These monitoring procedures are used only when AAAHC identifies noncompliance. If noncompliance is identified through validation reviews or complaint surveys, the State survey agency monitors corrections as specified at § 488.7(d). ++ AAAHC's capacity to report deficiencies to the surveyed facilities and respond to the facility's plan of correction in a timely manner. ++ AAAHC's capacity to provide us with electronic data in ASCII comparable code, and reports necessary for effective validation and assessment of the organization's survey process. ++ The adequacy of AAAHC's staff and other resources, and its financial viability. ++ AAAHC's capacity to adequately fund required surveys. ++ AAAHC's policies with respect to whether surveys are announced or unannounced, to assure that surveys are unannounced. ++ AAAHC's agreement to provide us with a copy of the most current accreditation survey together with any other information related to the survey as we may require (including corrective action plans). IV. Response to Public Comments and Notice Upon Completion of Evaluation Because of the large number of public comments we normally receive on **Federal Register** documents, we are not able to acknowledge or respond to them individually. We will consider all comments we receive by the date and time specified in the DATES section of this preamble, and, when we proceed with a subsequent document, we will respond to the comments in the preamble to that document. Upon completion of our evaluation, including evaluation of comments received as a result of this notice, we will publish a final notice in the **Federal Register** announcing the result of our evaluation. V. Collection of Information Requirements This document does not impose information collection and recordkeeping requirements. Consequently, it need not be reviewed by the Office of Management and Budget under the authority of the Paperwork Reduction Act of 1995 (44 U.S.C. 35 *et seq.* ). VI. Regulatory Impact Statement In accordance with the provisions of Executive Order 12866 (September 1993, Regulatory Planning and Review, the Regulatory Flexibility Act

(RFA)(September 19, 1980, Pub. L. 96-354)), the Office of Management and Budget did not review this proposed notice. In accordance with Executive Order 13132, we have determined that this proposed notice would not have a significant effect on the rights of States, local or tribal governments. Authority: Section 1865 of the Social Security Act (42 U.S.C. 1395bb). (Catalog of Federal Domestic Assistance Program No. 93.778, Medical Assistance Program; No. 93.773, Medicare—Hospital Insurance Program; and No. 93.774, Medicare—Supplementary Medical Insurance Program) Dated: June 10, 2008. Kerry Weems, Acting Administrator, Centers for Medicare & Medicaid Services. [FR Doc. E8-14647 Filed 6-26-08; 8:45 am] BILLING CODE 4120-01-P DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Medicare & Medicaid Services [CMS-1400-GNC] RIN 0938-AP34 Medicare Program; Criteria and Standards for Evaluating Intermediary and Carrier Performance During Fiscal Year 2009 AGENCY: Centers for Medicare and Medicaid Services (CMS), HHS. ACTION: General notice with comment period. SUMMARY: This general notice with comment period describes the criteria and standards to be used for evaluating the performance of fiscal intermediaries

(FIs)and carriers in the administration of the Medicare program. The results of these evaluations are considered whenever we enter into, renew, or terminate a FI agreement, carrier contract, or take other contract actions, for example, assigning or reassigning providers or services to a FI or designating regional or national intermediaries. We are requesting public comment on these criteria and standards. DATES: *Effective Date:* The criteria and standards are effective on October 1, 2008. *Comment Date:* To be assured consideration, comments must be received no later than 5 p.m. on August 26, 2008. ADDRESSES: In commenting, please refer to file code CMS-1400-GNC. Because of staff and resource limitations, we cannot accept comments by facsimile

(FAX)transmission. You may submit comments in one of four ways (please choose only one of the ways listed): 1. *Electronically.* You may submit electronic comments on this regulation to *http://www.regulations.gov.* Follow the instructions for “Comment or Submission” and enter the filecode to find the document accepting comments. 2. *By regular mail.* You may mail written comments (one original and two copies) to the following address ONLY: Centers for Medicare & Medicaid Services, Department of Health and Human Services, Attention: CMS-1400-GNC, P.O. Box 8013, Baltimore, MD 21244-8013. Please allow sufficient time for mailed comments to be received before the close of the comment period. 3. *By express or overnight mail.* You may send written comments (one original and two copies) to the following address ONLY: Centers for Medicare & Medicaid Services, Department of Health and Human Services, Attention: CMS-1400-GNC, Mail Stop C4-26-05, 7500 Security Boulevard, Baltimore, MD 21244-1850. 4. *By hand or courier.* If you prefer, you may deliver (by hand or courier) your written comments (one original and two copies) before the close of the comment period to either of the following addresses: a. Room 445-G, Hubert H. Humphrey Building, 200 Independence Avenue, SW., Washington, DC 20201. (Because access to the interior of the HHH Building is not readily available to persons without Federal Government identification, commenters are encouraged to leave their comments in the CMS drop slots located in the main lobby of the building. A stamp-in clock is available for persons wishing to retain a proof of filing by stamping in and retaining an extra copy of the comments being filed.) b. 7500 Security Boulevard, Baltimore, MD 21244-1850. If you intend to deliver your comments to the Baltimore address, please call telephone number

(410)786-7195 in advance to schedule your arrival with one of our staff members. Comments mailed to the addresses indicated as appropriate for hand or courier delivery may be delayed and received after the comment period. Submission of comments on paperwork requirements. You may submit comments on this document's paperwork requirements by following the instructions at the end of the “Collection of Information Requirements” section in this document. For information on viewing public comments, see the beginning of the SUPPLEMENTARY INFORMATION section. FOR FURTHER INFORMATION CONTACT: Lee Ann Crochunis,

(410)786-3362. SUPPLEMENTARY INFORMATION: Inspection of Public Comments: All comments received before the close of the comment period are available for viewing by the public, including any personally identifiable or confidential business information that is included in a comment. We post all comments received before the close of the comment period on the following Web site as soon as possible after they have been received: *http://www.regulations.gov.* Follow the search instructions on that Web site to view public comments. Comments received timely will also be available for public inspection as they are received, generally beginning approximately 3 weeks after publication of a document, at the headquarters of the Centers for Medicare & Medicaid Services, 7500 Security Boulevard, Baltimore, MD 21244, Monday through Friday of each week from 8:30 a.m. to 4 p.m. To schedule an appointment to view public comments, phone 1-800-743-3951. I. Background A. Medicare Part A—Hospital Insurance Under section 1816 of the Social Security Act (the Act), public or private organizations and agencies participate in the administration of Part A (Hospital Insurance) of the Medicare program under agreements with CMS. These agencies or organizations, known as fiscal intermediaries (FIs), determine whether medical services are covered under Medicare, determine correct payment amounts and then make payments to the health care providers (for example, hospitals, skilled nursing facilities (SNFs), and community mental health centers) on behalf of the beneficiaries. Section 1816(f) of the Act requires us to develop criteria, standards, and procedures to evaluate an FI's performance of its functions under its agreement. Section 1816(e)(4) of the Act requires us to designate regional agencies or organizations, which are already Medicare FIs under section 1816 of the Act, to perform claim processing functions for freestanding home health agency

(HHA)claims. We refer to these organizations as Regional Home Health Intermediaries (RHHIs) under 42 CFR 421.117. The evaluation of FI performance is part of our contract management process. These evaluations need not be limited to the current fiscal year (FY), other fixed term basis, or agreement term. B. Medicare Part B—Supplementary Medical Insurance Under section 1842 of the Act, we are authorized to enter into contracts with carriers to fulfill various functions in the administration of Part B, Supplementary Medical Insurance of the Medicare program. Beneficiaries, physicians, and suppliers of services submit claims to these carriers. The carriers determine whether the services are covered under Medicare and the amount payable for the services or supplies, and then make payment to the appropriate party. Under section 1842(b)(2) of the Act, we are required to develop criteria, standards, and procedures to evaluate a carrier's performance of its functions under its contract. Evaluations of Medicare fee-for-service

(FFS)contractor performance need not be limited to the current Fiscal Year (FY), other fixed term basis, or contract term. The evaluation of carrier performance is part of our contract management process. C. Development and Publication of Criteria and Standards In addition to the statutory requirements, § 421.120, § 421.122, and § 421.201, provide for publication of a **Federal Register** notice to announce the criteria and standards for FIs and carriers before the beginning of each evaluation period. In the October 1, 2007 **Federal Register** (72 FR 55775), we published a general notice with comment period the current criteria and standards for FIs and carriers. To the extent possible, we make every effort to publish the criteria and standards before the beginning of the FY, which is October 1. If we do not publish a **Federal Register** notice before the new FY begins, readers may presume that until and unless notified otherwise, the criteria and standards that were in effect for the previous FY remain in effect. In those instances in which we are unable to meet our goal of publishing the subject **Federal Register** notice before the beginning of the FY, we may publish the criteria and standards notice at any subsequent time during the year. If we publish a notice in this manner, the evaluation period for the criteria and standards that are the subject of the notice will be effective beginning on the first day of the first month following publication of this notice in the **Federal Register** . Any revised criteria and standards will measure performance prospectively; that is, any new criteria and standards in the notice will be applied only to performance after the effective date listed on the notice. It is not our intention to revise the criteria and standards that will be used during the evaluation period once this information is published in a **Federal Register** notice. However, on occasion, either because of administrative action or statutory mandate, there may be a need for changes that have a direct impact on the criteria and standards previously published, or that require the addition of new criteria or standards, or that cause the deletion of previously published criteria and standards. If we make these changes, we will publish a **Federal Register** notice before implementation of the changes. In all instances, necessary manual issuances will be published to ensure that the criteria and standards are applied uniformly and accurately. Also, as in previous years, this **Federal Register** notice will be republished and the effective date revised if changes are warranted as a result of the public comments received on the criteria and standards. The Medicare Prescription Drug, Improvement, and Modernization Act of 2003

(MMA)(Pub. L. 108-173) was enacted on December 8, 2003. Section 911 of the MMA establishes the Medicare FFS Contracting Reform

(MCR)initiative that is being implemented over the next several years. This provision requires that we use competitive procedures to replace our current FIs and carriers with Medicare Administrative Contractors (MACs). The MMA requires that we compete and transition all work to MACs by October 1, 2011. FIs and carriers will continue administering Medicare FFS work as may be required until the final competitively selected MAC is up and operating. We will continue to develop and publish standards and criteria for use in evaluating the performance of FIs and carriers as long as these types of contractors exist. II. Analysis of and Response to Public Comments Received on FY 2008 Criteria and Standards We received three comments in response to the October 1, 2007 **Federal Register** general notice with comment. All comments were reviewed, but none necessitated reissuance of the FY 2008 Criteria and Standards. Comments submitted did not pertain specifically to the FY 2007 Criteria and Standards. III. Criteria and Standards—General Basic principles of the Medicare program are to pay claims promptly and accurately, and to foster good beneficiary and provider relations. Contractors must administer the Medicare program efficiently and economically. The goal of performance evaluation is to ensure that contractors meet their contractual obligations. We measure contractor performance to ensure that contractors do what is required of them by statute, regulation, contract, and our directives. We have developed a contractor oversight program for FY 2009 that outlines what is expected of the contractor; measures the performance of the contractor; evaluates the contractor's performance against those expectations; and provides for appropriate contract action based upon the evaluation of the contractor's performance. As a means to monitor the accuracy of Medicare FFS payments, we have established the Comprehensive Error Rate Testing

(CERT)program that measures and reports error rates for claims payment decisions made by carriers and FIs. Since November 2003, the CERT program has been measuring and reporting claims payment error rates for each individual carrier. FI-specific rates became available November 2004. These rates measure not only how well contractors are doing at implementing automated review edits and identifying which claims to subject to manual medical review, but they also measure the impact of the contractor's provider outreach/education, as well as the effectiveness of the contractor's provider call center(s). We will use these contractor-specific error rates as a means to evaluate a contractor's performance. Several times throughout this notice, we refer to the appropriate reading level of letters, decisions, or correspondence that are mailed or otherwise transmitted to Medicare beneficiaries from intermediaries or carriers. In those instances, appropriate reading level is defined as whether the communication is below the eighth grade reading level unless it is obvious that an incoming request from the beneficiary contains language written at a higher level. In these cases, the appropriate reading level is tailored to the capacities and circumstances of the intended recipient. In addition to evaluating performance based upon our expectations for FY 2009, we may also conduct follow-up evaluations throughout FY 2009 of areas in which contractor performance was out of compliance with statute, regulations, and our performance expectations during prior review years where contractors were required to submit a Performance Improvement Plan (PIP). We may also utilize Statement of Auditing Standards-70 (SAS-70) reviews as a means to evaluate contractors in some or all business functions. In FY 2001, we established the Contractor Rebuttal Process as a commitment to continual improvement of contractor performance evaluation (CPE). We will continue the use of this process in FY 2009. The Contractor Rebuttal Process provides the contractors an opportunity to submit a written rebuttal of CPE findings of fact. Whenever we conduct an evaluation of contractor operations, contractors have 7 calendar days from the date of the CPE review exit conference to submit a written rebuttal. The CPE review team or, if appropriate, the individual reviewer considers the contents of the rebuttal before the issuance of the final CPE report to the contractor. The FY 2009 CPE for FIs and carriers is structured into five criteria designed to meet the stated objectives. The first criterion, claims processing, measures contractual performance against claims processing accuracy and timeliness requirements, as well as activities in handling appeals. Within the claims processing criterion, we have identified those performance standards that are mandated by legislation, regulation, or judicial decision. These standards include claims processing timeliness, the accuracy of Medicare Summary Notices (MSNs), the timeliness of FI and carrier redeterminations, and the appropriateness of the reading level and content of FI and carrier redetermination letters. Further evaluation in the claims processing criterion may include, but is not limited to, the accuracy of claims processing, the percent of claims paid with interest, the accuracy of redeterminations, timeliness of forwarding case files to and effectuation of Qualified Independent Contractor

(QIC)decisions, and effectuation of administrative law judge

(ALJ)decisions. The second criterion, customer service, assesses the adequacy of the service provided to customers by the contractor in its administration of the Medicare program. Functions that may be evaluated under this criterion include, but will not be limited to, the following:

(1)Timeliness and accuracy of all correspondence to providers;

(2)monitoring the quality of replies provided by the contractor's provider telephone customer service representatives (quality call monitoring); and

(3)provider outreach and education activities. The third criterion, payment safeguards, evaluates whether the Medicare Trust Fund is safeguarded against inappropriate program expenditures. Intermediary and carrier performance may be evaluated in the areas of Medical Review (MR), Medicare Secondary Payer (MSP), Overpayments (OP), and Provider Enrollment (PE). In addition, FIs performance may be evaluated in the area of Audit and Reimbursement (A&R). In FY 1996, the Congress enacted the Health Insurance Portability and Accountability Act (HIPAA), Medicare Integrity Program, giving us the authority to contract with entities other than, but not excluding, Medicare carriers and intermediaries to perform certain program safeguard functions. In situations where one or more program safeguard functions are contracted to another entity, we may evaluate the flow of communication and information between a Medicare FFS contractor and the payment safeguard contractor. All benefit integrity functions have been transitioned from the intermediaries and carriers to the program safeguard contractors. Mandated performance standards for FIs in the payment safeguards criterion include the accuracy of decisions on SNF demand bills and the timeliness of processing Tax Equity and Fiscal Responsibility Act (TEFRA) target rate adjustments, exceptions, and exemptions. There are no mandated performance standards for carriers in the payment safeguards criterion. FIs and carriers may also be evaluated on any Medicare Integrity Program

(MIP)activities if performed under their agreement or contract. The fourth criterion, fiscal responsibility, evaluates the contractor's efforts to protect the Medicare program and the public interest. Contractors must effectively manage Federal funds for both the payment of benefits and the costs of administration under the Medicare program. Proper financial and budgetary controls, including internal controls, must be in place to ensure contractor compliance with its agreement with HHS and CMS. Additional functions reviewed under this criterion may include, but are not limited to, adherence to approved budget, compliance with the Budget and Performance Requirements (BPRs), and compliance with financial reporting requirements. The fifth and final criterion, administrative activities, measures a contractor's administrative management of the Medicare program. A contractor must efficiently and effectively manage its operations. Proper systems security (general and application controls), Automated Data Processing

(ADP)maintenance, and disaster recovery plans must be in place. A contractor's evaluation under the administrative activities criterion may include, but is not limited to, establishment, application, documentation, and effectiveness of internal controls that are essential in all aspects of a contractor's operation, as well as the degree to which the contractor cooperates with us in complying with the Federal Managers' Financial Integrity Act of 1982 (FMFIA). Administrative activities evaluations may also include reviews related to contractor implementation of our general instructions and data and reporting requirements. We have developed separate measures for RHHIs in order to evaluate the distinct RHHI functions. These functions include the processing of claims from freestanding HHAs, hospital-affiliated HHAs, and hospices. Through an evaluation using these criteria and standards, we may determine whether the RHHI is effectively and efficiently administering the program benefit or whether the functions should be moved from one FIs to another in order to gain that assurance. In sections IV. through VI. of this notice, we list the criteria and standards to be used for evaluating the performance of FIs, RHHIs, and carriers. IV. Criteria and Standards for Fiscal Intermediaries A. Claims Processing Criterion The claims processing criterion contains the following three mandated standards: *Standard 1.* Not less than 95.0 percent of clean electronically submitted nonperiodic interim payment claims are paid within statutorily specified timeframes. Clean claims are defined as claims that do not require Medicare FIs to investigate or develop outside of their Medicare operations on a prepayment basis. Specifically, the Act specifies that clean nonperiodic interim payment electronic claims be paid no earlier than the 14th day after the date of receipt, and that interest is payable for any clean claims if payment is not issued by the 31st day after the date of receipt. *Standard 2.* Redetermination letters prepared in response to beneficiary initiated appeal requests are written in a manner calculated to be understood by the beneficiary. Letters must contain the required elements as specified in § 405.956. *Standard 3.* All redeterminations must be concluded and mailed within 60 days of receipt of the request, unless the party submits documentation after the request, in which case the decision-making timeframe is extended for up to 14 calendar days for each submission. Because FIs process many claims for benefits under the Part B portion of the Medicare Program, we also may evaluate how well a FI follows the procedures for processing appeals of any claims for Part B benefits. *Additional functions that may be evaluated under this criterion include, but are not limited to, the following:* • Accuracy of claims processing. • Remittance advice transactions. • Establishment and maintenance of a relationship with Common Working File

(CWF)Host. • Accuracy of redetermination decisions. • QIC case file requirements. • Timely and accurate effectuation of appeal decisions. • Accuracy and timeliness of processing appeals and clerical error reopenings as set forth in part 405, subpart I (§ 405.900 *et seq.* ). B. Customer Service Criterion *Functions that may be evaluated under this criterion include, but are not limited to, the following:* • Maintaining a properly programmed interactive voice response system to assist with inquiries. • Performing quality call monitoring. • Training customer service representatives. • Entering valid call center performance data in the customer service assessment and management system or its successor, the provider inquiry evaluation system. • Providing timely and accurate written replies to providers that address the concerns raised and that are written with an appropriate customer-friendly tone and clarity. • Ensuring written correspondence is evaluated for quality. • Conducting provider outreach and education-activities. • Effectively maintaining an Internet Web site dedicated to furnishing providers and physicians timely, accurate, and useful Medicare program information. C. Payment Safeguards Criterion The Payment Safeguard criterion contains the following two mandated standards: *Standard 1.* Decisions on SNF demand bills are accurate. *Standard 2.* TEFRA target rate adjustments, exceptions, and exemptions are processed within mandated timeframes. Specifically, applications must be processed to completion within 75 days after receipt by the contractor or returned to the hospitals as incomplete within 60 days of receipt. FIs may also be evaluated on any MIP activities if performed under their Part A contractual agreement. *These functions and activities include, but are not limited to, the following:* • Audit and Reimbursement ++ Performing the activities specified in our general instructions for conducting audit and settlement of Medicare cost reports. ++ Establishing accurate interim payments. • Medical Review ++ Increasing the effectiveness of medical review activities. ++ Exercising accurate and defensible decision-making on medical reviews. ++ Collaborating with other internal components and external entities to ensure the effectiveness of medical review activities. • Medicare Secondary Payer ++ Accurately following MSP claim development and edit procedures. ++ Auditing hospital files and claims to determine that claims are being filed to Medicare appropriately. ++ Supporting the Coordination of Benefits Contractor's efforts to identify responsible payers primary to Medicare. ++ Supporting the MSP Recovery functions for provider, physician or other supplier debts and duplicate provider, physician or other supplier payments. ++ Accurately reporting MSP savings. • Overpayments ++ Collecting and referring Medicare debts in a timely manner. ++ Accurately reporting and collecting overpayments. ++ Adhering to our instructions for management of Medicare Trust Fund debts. • Provider Enrollment ++ Complying with assignment of staff to the provider enrollment function and training the staff in procedures and verification techniques. ++ Complying with the operational standards relevant to the process for enrolling providers. D. Fiscal Responsibility Criterion We may review the FI's efforts to establish and maintain appropriate financial and budgetary internal controls over benefit payments and administrative costs. Proper internal controls must be in place to ensure that contractors comply with their agreements with us. *Additional functions that may be reviewed under the fiscal responsibility criterion include, but are not limited to, the following:* • Adherence to approved program management and MIP budgets. • Compliance with the BPRs. • Compliance with financial reporting requirements. • Control of administrative cost and benefit payments. E. Administrative Activities Criterion We may measure an FI's administrative ability to manage the Medicare program. We may evaluate the efficiency and effectiveness of its operations, its system of internal controls, and its compliance with our directives and initiatives. We may measure an FI's efficiency and effectiveness in managing its operations. Proper systems security (general and application controls), ADP maintenance, and disaster recovery plans must be in place. A FI must also test system changes to ensure the accurate implementation of our instructions. *Our evaluation of FI under the administrative activities criterion may include, but is not limited to, reviews of the following:* • Systems security. • ADP maintenance (configuration management, testing, change management, and security). • Implementation of the Electronic Data Interchange

(EDI)standards adopted for use under HIPAA. • Disaster recovery plan and systems contingency plan. • Data and reporting requirements implementation. • Internal controls establishment and use, including the degree to which the contractor cooperates with the Secretary in complying with the FMFIA. • Implementation of our general instructions. V. Criteria and Standards for Regional Home Health Intermediaries (RHHIs) *The following three standards are mandated for the RHHI criterion:* *Standard 1.* Not less than 95.0 percent of clean electronically submitted nonperiodic interim payment home health and hospice claims are paid within statutorily specified timeframes. Clean claims are defined as claims that do not require Medicare FIs to investigate or develop them outside of their Medicare operations on a prepayment basis. Specifically, the statute specifies that clean non-periodic interim payment electronic claims be paid no earlier than the 14th day after the date of receipt, and that interest is payable for any clean claims if payment is not issued by the 31st day after the date of receipt. *Standard 2.* Redetermination letters prepared in response to beneficiary initiated appeal requests are written in a manner calculated to be understood by the beneficiary. Letters must contain the required elements as specified in § 405.956. *Standard 3.* All redeterminations must be concluded and mailed within 60 days of receipt of the request, unless the party submits documentation after the request, in which case the decision-making timeframe is extended for up to 14 calendar days for each submission. We may use this criterion to review an RHHI's performance for handling the HHA and hospice workload. This includes processing HHA and hospice claims timely and accurately, properly paying and settling HHA cost reports, and accurately processing redeterminations of initial determinations from beneficiaries, HHAs, and hospices. VI. Criteria and Standards for Carriers A. Claims Processing Criterion The claims processing criterion contains the following four mandated standards: *Standard 1.* Not less than 95.0 percent of clean electronically submitted claims are processed within statutorily specified timeframes. Clean claims are defined as claims that do not require Medicare carriers to investigate or develop outside of their Medicare operations on a prepayment basis. Specifically, the Act specifies that clean non-periodic interim payment electronic claims be paid no earlier than the 14th day after the date of receipt, and that interest is payable for any clean claims if payment is not issued by the 31st day after the date of receipt. *Standard 2.* Ninety-eight percent of MSNs are properly generated. Our expectation is that MSN messages are accurately reflecting the services provided. *Standard 3.* Redetermination letters prepared in response to beneficiary initiated appeal requests are written in a manner calculated to be understood by the beneficiary. Letters must contain the required elements as specified in § 405.956. *Standard 4.* All redeterminations must be concluded and mailed within 60 days of receipt of the request, unless the party submits documentation after the request, in which case the decision-making timeframe is extended for up to 14 calendar days for each submission. *Additional functions that may be evaluated under this criterion include, but are not limited to, the following:* • Accuracy of claims processing. • Remittance advice transactions. • Establishment and maintenance of relationship with Common Working File

(CWF)Host. • Accuracy of redetermination decisions. • QIC case file requirements. • Timely and accurate effectuation of appeal decisions. • Accuracy and timeliness of processing appeals and clerical error reopenings as set forth in part 405, subpart I (§ 405.900 *et seq.* ). B. Customer Service Criterion Contractors must meet our performance expectations that providers are served by prompt and accurate administration of the program in accordance with all applicable laws, regulations, and our general instructions. *Functions that may be evaluated under this criterion include, but are not limited to, the following:* • Maintaining a properly programmed interactive voice response system to assist with inquiries. • Performing quality call monitoring. • Training customer service representatives. • Entering valid call center performance data in the customer service assessment and management system or its successor the provider inquiry evaluation system. • Providing timely and accurate written replies to providers that address the concerns raised and that are written with an appropriate customer-friendly tone and clarity. • Ensuring written correspondence is evaluated for quality. • Conducting provider outreach and education, activities. • Effectively maintaining an Internet Web site dedicated to furnishing providers timely, accurate, and useful Medicare program information. C. Payment Safeguards Criterion Carriers may be evaluated on any MIP activities if performed under their contracts. * In addition, other carrier functions and activities that may be reviewed under this criterion include, but are not limited to the following: * • Medical Review ++ Increasing the effectiveness of medical review activities. ++ Exercising accurate and defensible decision-making on medical reviews. ++ Collaborating with other internal components and external entities to ensure the effectiveness of medical review activities. • Medicare Secondary Payer ++ Accurately following MSP claim development/edit procedures. ++ Supporting the Coordination of Benefits Contractor's efforts to identify responsible payers primary to Medicare. ++ Supporting the Medicare Secondary Payer Recovery functions for provider, physician or other supplier debts and duplicate provider, physician or other supplier payments. ++ Accurately reporting MSP savings. • Overpayments ++ Collecting and referring Medicare debts in a timely manner. ++ Accurately reporting and collecting overpayments. ++ Compliance with our instructions for management of Medicare Trust Fund debts. • Provider Enrollment ++ Complying with assignment of staff to the provider enrollment function and training staff in procedures and verification techniques. ++ Complying with the operational standards relevant to the process for enrolling suppliers. D. Fiscal Responsibility Criterion We may review the carrier's efforts to establish and maintain appropriate financial and budgetary internal controls over benefit payments and administrative costs. Proper internal controls must be in place to ensure that contractors comply with their contracts. *Additional functions that may be reviewed under the Fiscal Responsibility criterion include, but are not limited to, the following:* • Adherence to approved program management and MIP budgets. • Compliance with the BPRs. • Compliance with financial reporting requirements. • Control of administrative cost and benefit payments. E. Administrative Activities Criterion We may measure a carrier's administrative ability to manage the Medicare program. We may evaluate the efficiency and effectiveness of its operations, its system of internal controls, and its compliance with our directives and initiatives. We may measure a carrier's efficiency and effectiveness in managing its operations. Proper systems security (general and application controls), ADP maintenance, and disaster recovery plans must be in place. Also, a carrier must test system changes to ensure accurate implementation of our instructions. *Our evaluation of a carrier under this criterion may include, but is not limited to, reviews of the following:* • Systems security. • ADP maintenance (configuration management, testing, change management, and security). • Disaster recovery plan/systems contingency plan. • Data and reporting requirements implementation. • Internal controls establishment and use, including the degree to which the contractor cooperates with the Secretary in complying with the FMFIA. • Implementation of the Electronic Data Interchange

(EDI)standards adopted for use under the HIPAA. • Implementation of our general instructions. VII. Action Based on Performance Evaluations We evaluate a contractor's performance against applicable program requirements for each criterion. Each contractor must certify that all information submitted to us relating to the contract management process, including, without limitation, all files, records, documents and data, whether in written, electronic, or other form, is accurate and complete to the best of the contractor's knowledge and belief. A contractor is required to certify that its files, records, documents, and data are not manipulated or falsified in an effort to receive a more favorable performance evaluation. A contractor must further certify that, to the best of its knowledge and belief, the contractor has submitted, without withholding any relevant information, all information required to be submitted for the contract management process under the authority of applicable law(s), regulation(s), contract(s), or our manual provision(s). Any contractor that makes a false, fictitious or fraudulent certification may be subject to criminal or civil prosecution, as well as appropriate administrative action. This administrative action may include debarment or suspension of the contractor, as well as the termination or nonrenewal of a contract. If a contractor meets the level of performance required by operational instructions, it meets the requirements of that criterion. When we determine a contractor is not meeting performance requirements, we will use the terms “major nonconformance” or “minor nonconformance” to classify our findings. A major nonconformance is a nonconformance that is likely to result in failure of the supplies or services, or to materially reduce the usability of the supplies or services for their intended purpose. A minor nonconformance is a nonconformance that is not likely to materially reduce the usability of the supplies or services for their intended purpose, or is a departure from established standards having little bearing on the effective use or operation of the supplies or services. The contractor will be required to develop and implement PIPs for findings determined to be either a major or minor nonconformance. The contractor will be monitored to ensure effective and efficient compliance with the PIP, and to ensure improved performance when requirements are not met. The results of performance evaluations and assessments under all criteria applying to FIs, carriers, and RHHIs will be used for contract management activities and will be published in the contractor's annual Report of Contractor Performance (RCP). We may initiate administrative actions as a result of the evaluation of contractor performance based on these performance criteria. Under sections 1816 and 1842 of the Act, we consider the results of the evaluation in our determinations when— • Entering into, renewing, or terminating agreements or contracts with contractors; and • Deciding other contract actions for intermediaries and carriers (such as deletion of an automatic renewal clause). These decisions are made on a case-by-case basis and depend primarily on the nature and degree of performance. *More specifically, these decisions depend on the following:* ++ Relative overall performance compared to other contractors. ++ Number of criteria in which nonconformance occurs. ++ Extent of each nonconformance. ++ Relative significance of the requirement for which nonconformance occurs within the overall evaluation program. ++ Efforts to improve program quality, service, and efficiency. ++ Deciding the assignment or reassignment of providers and designation of regional or national intermediaries for classes of providers. We make individual contract action decisions after considering these factors in terms of their relative significance and impact on the effective and efficient administration of the Medicare program. In addition, if the cost incurred by the FI, RHHI, or carrier to meet its contractual requirements exceeds the amount that we find to be reasonable and adequate to meet the cost that must be incurred by an efficiently and economically operated FIs or carrier, these high costs may also be grounds for adverse action. VIII. Collection of Information Requirements This document does not impose information collection and recordkeeping requirements. Consequently the Office of Management and Budget need not review it under the authority of the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 *et seq.* ). IX. Response to Comments Because of the large number of items of correspondence we normally receive on **Federal Register** documents published for comment, we are unable to acknowledge or respond to them individually. We will consider all comments we receive by the date and time specified in the DATES section of this notice, and, if we proceed with a subsequent document, we will respond to the comments in the section entitled as “Analysis of and Response to Public Comments Received on FY 2009 Criteria and Standards” of that document. Authority: Sections 1816(f), 1834(a)(12), and 1842(b) of the Social Security Act (42 U.S.C. 1395h(f), 1395m(a)(12), and 1395u(b)). (Catalog of Federal Domestic Assistance Program No. 93.773, Medicare—Hospital Insurance, and Program No. 93.774, Medicare—Supplementary Medical Insurance Program) Dated: May 16, 2008. Kerry Weems, Acting Administrator, Centers for Medicare & Medicaid Services. [FR Doc. E8-14641 Filed 6-26-08; 8:45 am] BILLING CODE 4120-01-P DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Medicare & Medicaid Services [CMS-3201-N] Medicare Program; Meeting of the Medicare Evidence Development and Coverage Advisory Committee—August 20, 2008 AGENCY: Centers for Medicare & Medicaid Services (CMS), HHS. ACTION: Notice of meeting. SUMMARY: This notice announces that a public meeting of the Medicare Evidence Development & Coverage Advisory Committee (MedCAC) (“Committee”) will be held on Wednesday, August 20, 2008. The Committee generally provides advice and recommendations concerning the adequacy of scientific evidence needed to determine whether certain medical items and services are reasonable and necessary under the Medicare statute. This meeting will focus on the oncologic indications of 2-[F-18] Fluoro-D-Glucose

(FDG)positron emission tomography

(PET)for nine cancers (brain, cervical, small cell lung, ovarian, pancreatic, testicular, prostate, bladder, and kidney). The panel will review the scientific evidence of the impact of PET as part of a management strategy to improve patient-centered outcomes. The panel will also consider data generated under a current national coverage determination that provides coverage for PET for specified cancers when additional data are prospectively collected. The meeting will discuss the various kinds of evidence that are useful to support requests for Medicare coverage in this field. This meeting is open to the public in accordance with the Federal Advisory Committee Act (5 U.S.C. App. 2, section 10(a)). DATES: *Meeting Date:* The public meeting will be held 7:30 a.m. until 4:30 p.m., d.s.t. on Wednesday, August 20, 2008. *Deadline for Submission of Written Comments:* Written comments must be received at the address specified in the ADDRESSES section of this notice by 5 p.m., d.s.t. on July 21, 2008. Once submitted, comments are final. *Deadlines for Speaker Registration and Presentation Materials:* The deadline to register to be a speaker, and to submit Powerpoint presentation materials and writings that will be used in support of an oral presentation, is 5 p.m., d.s.t. on Monday, July 21, 2008. Speakers may register by phone or via e-mail by contacting the person listed in the FOR FURTHER INFORMATION CONTACT section of this notice. Presentation materials must be received at the address specified in the ADDRESSES section of this notice. *Deadline for All Other Attendees Registration:* Individuals may register by phone or via e-mail by contacting the person listed in the FOR FURTHER INFORMATION CONTACT section of this notice by 5 p.m., d.s.t. on Wednesday, August 13, 2008. *Deadline for Submitting a Request for Special Accommodations:* Persons attending the meeting who are hearing or visually impaired, or have a condition that requires special assistance or accommodations, are asked to contact the Executive Secretary as specified in the FOR FURTHER INFORMATION CONTACT section of this notice no later than 5 p.m., d.s.t. Friday, August 8, 2008. ADDRESSES: *Meeting Location:* The meeting will be held in the main auditorium of the Centers for Medicare & Medicaid Services, 7500 Security Blvd, Baltimore, MD 21244. *Submission of Presentations and Comments:* Presentation materials and written comments that will be presented at the meeting must be submitted via e-mail to *MedCACpresentations@cms.hhs.gov* or by regular mail to the contact listed in the FOR FURTHER INFORMATION CONTACT section of this notice by the date specified in the DATES section of this notice. FOR FURTHER INFORMATION CONTACT: Maria Ellis, Executive Secretary for MedCAC, Centers for Medicare & Medicaid Services, Office of Clinical Standards and Quality, Coverage and Analysis Group, C1-09-06, 7500 Security Boulevard, Baltimore, MD 21244 or contact Ms. Ellis by phone (410-786-0309) or via e-mail at *Maria.Ellis@cms.hhs.gov* . SUPPLEMENTARY INFORMATION: I. Background MedCAC, formerly known as the Medicare Coverage Advisory Committee (MCAC), provides advice and recommendations to CMS regarding clinical issues. (For more information on MCAC, see the December 14, 1998 **Federal Register** (63 FR 68780).) This notice announces the August 20, 2008, public meeting of the Committee. During this meeting, the Committee will review the scientific evidence of the impact of PET as part of a management strategy to improve patient-centered outcomes. The Committee will focus on evidence regarding the use of FDG PET to inform the treating physician on cancer diagnosis, staging, detecting metastatic disease and detecting recurrence. Background information about this topic, including panel materials, will become available at *http://www.cms.hhs.gov/coverage.* II. Meeting Format This meeting is open to the public. The Committee will hear oral presentations from the public for approximately 30 minutes. The Committee may limit the number and duration of oral presentations to the time available. Your comments should focus on issues specific to the list of topics that we have proposed to the Committee. The list of research topics to be discussed at the meeting will be available on the following Web site prior to the meeting: *http://www.cms.hhs.gov/mcd/index_list.asp?list_type=mcac* . We require that you declare at the meeting whether you have any financial involvement with manufacturers (or their competitors) of any items or services being discussed. The Committee will deliberate openly on the topics under consideration. Interested persons may observe the deliberations, but the Committee will not hear further comments during this time except at the request of the chairperson. The Committee will also allow a 15-minute unscheduled open public session for any attendee to address issues specific to the topics under consideration. At the conclusion of the day, the members will vote and the Committee will make its recommendation(s) to CMS. III. Registration Instructions CMS' Coverage and Analysis Group is coordinating the meeting registration. While there is no registration fee, individuals must register to attend. You may register by contacting the person listed in the FOR FURTHER INFORMATION CONTACT section of this notice by the deadline listed in the DATES section of this notice. Please provide your full name (as it appears on your state-issued driver's license), address, organization, telephone, fax number(s), and e-mail address. You will receive a registration confirmation with instructions for your arrival at the CMS complex or you will be notified the seating capacity has been reached. IV. Security, Building, and Parking Guidelines This meeting will be held in a Federal government building; therefore, Federal security measures are applicable. We recommend that confirmed registrants arrive reasonably early, but no earlier than 45 minutes prior to the start of the meeting, to allow additional time to clear security. Security measures include the following: • Presentation of government-issued photographic identification to the Federal Protective Service or Guard Service personnel. • Inspection of vehicle's interior and exterior (this includes engine and trunk inspection) at the entrance to the grounds. Parking permits and instructions will be issued after the vehicle inspection. • Inspection, via metal detector or other applicable means of all persons brought entering the building. We note that all items brought into CMS, whether personal or for the purpose of presentation or to support a presentation, are subject to inspection. We cannot assume responsibility for coordinating the receipt, transfer, transport, storage, set-up, safety, or timely arrival of any personal belongings or items used for presentation or to support a presentation. Note: Individuals who are not registered in advance will not be permitted to enter the building and will be unable to attend the meeting. The public may not enter the building earlier than 30 to 45 minutes prior to the convening of the meeting. All visitors must be escorted in areas other than the lower and first floor levels in the Central Building. Authority: 5 U.S.C. App. 2, section 10(a). (Catalog of Federal Domestic Assistance Program No. 93.773, Medicare—Hospital Insurance; and Program No. 93.774, Medicare—Supplementary Medical Insurance Program) Dated: June 17, 2008. Barry M. Straube, Chief Medical Officer and Director, Office of Clinical Standards and Quality, Centers for Medicare & Medicaid Services. [FR Doc. E8-14649 Filed 6-26-08; 8:45 am] BILLING CODE 4120-01-P DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Medicare & Medicaid Services [CMS-1394-N] Medicare Program; Second Semi-Annual Meeting of the Advisory Panel on Ambulatory Payment Classification Groups—August 27-29, 2008 AGENCY: Centers for Medicare & Medicaid Services, Department of Health and Human Services. ACTION: Notice. SUMMARY: In accordance with section 10(a) of the Federal Advisory Committee Act

(FACA)(5 U.S.C. Appendix 2), this notice announces the second semi-annual meeting of the Advisory Panel on Ambulatory Payment Classification

(APC)Groups (the Panel) for 2008. The purpose of the Panel is to review the APC groups and their associated weights and to advise the Secretary of the Department of Health and Human Services

(DHHS)(the Secretary) and the Administrator of the Centers for Medicare & Medicaid Services

(CMS)(the Administrator) concerning the clinical integrity of the APC groups and their associated weights. We will consider the Panel's advice as we prepare the final rule that updates the hospital Outpatient Prospective Payment System

(OPPS)for CY 2009. DATES: *Meeting Dates:* We are scheduling the second semi-annual meeting in 2008 for the following dates and times: • Wednesday, August 27, 2008, 1 p.m. to 5 p.m. (e.d.t.) 1 • Thursday, August 28, 2008, 8 a.m. to 5 p.m. (e.d.t.) 1 • Friday, August 29, 2008, 8 a.m. to 12 noon (e.d.t.) 2 1 The times listed in this notice are approximate times; consequently, the meetings may last longer than listed in this notice—but will not begin before the posted times. 2 If the business of the Panel concludes on Thursday, August 28, 2008, there will be no Friday (August 29, 2008) meeting. Deadlines Deadline for Hardcopy Comments/Suggested Agenda Topics 5 p.m. (e.d.t.), Monday, August 4, 2008. Deadline for Hardcopy Presentations 5 p.m. (e.d.t.), Monday, August 4, 2008. Deadline for Attendance Registration 5 p.m. (e.d.t.), Wednesday, August 13, 2008. Deadline for Special Accommodations 5 p.m. (e.d.t.), Wednesday, August 13, 2008. *Submission of Materials to the Designated Federal Officer (DFO):* Because of staffing and resource limitations, we cannot accept written comments and presentations by FAX, nor can we print written comments and presentations received electronically for dissemination at the meeting. Only hardcopy comments and presentations can be reproduced for public dissemination. All hardcopy presentations *must be accompanied by Form CMS-20017 (revised 01/07).* The form is now available through the CMS Forms Web site. The Uniform Resource Locator

(URL)for linking to this form is as follows: *http://www.cms.hhs.gov/cmsforms/downloads/cms20017.pdf.* Presenters must use the most recent copy of CMS-20017 (updated 01/07) at the above URL. Additionally, presenters must *clearly* explain the action(s) that they are requesting CMS to take in the appropriate section of the form. They must also clarify their relationship to the organization that they represent in the presentation. Note: Issues that are vague, or that are outside the scope of the APC Panel's purpose, will not be considered for presentations and comments. There will be no exceptions to this rule. We appreciate your cooperation on this matter. We are also requiring electronic versions of the written comments and presentations, in addition to the hardcopies, to be sent electronically to the Panel members for their review before the meeting. In summary, presenters and/or commenters must do the following: • Send both electronic and hardcopy versions of their presentations and written comments by the prescribed deadlines. • Send electronic transmissions to the e-mail address below. • Do not send pictures of patients in any of the documents unless their faces have been blocked out. • Do not send documents electronically that have been archived. • Mail (or send by courier) to the DFO all hardcopies, accompanied by Form CMS-20017 (revised 01/07), if they are presenting, as specified in the FURTHER INFORMATION CONTACT section of this notice. • Commenters are not required to send Form CMS-20017 with their written comments. ADDRESSES: The meeting will be held in the Auditorium, CMS Central Office, 7500 Security Boulevard, Baltimore, Maryland 21244-1850. FOR FURTHER INFORMATION CONTACT: Shirl Ackerman-Ross, DFO, CMS, CMM, HAPG, DOC, 7500 Security Boulevard, Mail Stop C4-05-17, Baltimore, MD 21244-1850. *Phone:*

(410)786-4474. Note: We recommend that you advise couriers of the following information: When delivering hardcopies of presentations to CMS, if no one answers at the above phone number, call

(410)786-4532 or

(410)786-9316.) E-mail address for comments, presentations, and registration requests is *CMS APCPanel@cms.hhs.gov.* Note: There is NO underscore in this e-mail address; there is a SPACE between CMS and APCPanel. News media representatives must contact our Public Affairs Office at

(202)690-6145. *Advisory Committees' Information Lines:* The phone numbers for the CMS Federal Advisory Committee Hotline are 1-877-449-5659 (toll free) and

(410)786-9379 (local). *Web Sites:* The following information is available on the CMS Web site at *http://www.cms.hhs.gov/FACA/05_AdvisoryPanelonAmbulatoryPaymentClassificationGroups.asp#TopOfPage* . Note: There is an UNDERSCORE after FACA/05(like this_); there is no space. • Additional information on the APC meeting agenda topics. • Updates to the Panel's activities. • Copies of the current Charter. • Membership requirements. You may also search information about the APC Panel and its membership in the FACA database at the following URL: *https://www.fido.gov/facadatabase/public.asp.* SUPPLEMENTARY INFORMATION: I. Background The Secretary is required by section 1833(t)(9)(A) of the Social Security Act (the Act), as amended by section 201(h) of the Medicare, Medicaid, and SCHIP Balanced Budget Refinement Act of 1999

(BBRA)(Pub. L. 106-113), and re-designated by section 202(a)(2) of the BBRA to establish and consult with an expert outside advisory panel regarding the clinical integrity of the APC groups and weights that are components of the hospital OPPS. The APC Panel meets up to three times annually. The Charter requires that the Panel must be fairly balanced in its membership in terms of the points of view represented and the functions to be performed. The Panel consists of up to 15 members who are representatives of providers and a Chair. Each Panel member must be employed full-time by a hospital, hospital system, or other Medicare provider subject to payment under the OPPS. All Panel members must have technical expertise that enables them to participate fully in the work of the Panel. The expertise encompasses hospital payment systems, hospital medical-care delivery systems, provider billing systems, outpatient payment requirements, APC groups, Current Procedural Terminology codes, and the use and payment of drugs and medical devices in the outpatient setting, as well as other forms of relevant expertise. Details regarding membership requirements for the APC Panel are found on the FACA and CMS Web sites as listed above. *The Panel presently consists of the following members:* • E.L. Hambrick, M.D., J.D., Chair. • Gloryanne Bryant, B.S., R.H.I.A., R.H.I.T., C.C.S. • Patrick Grusenmeyer, Sc.D. • Hazel Kimmel, R.N., C.C.S., C.P.C. • Michael Mills, Ph.D. • Thomas Munger, M.D. • Agatha Nolen, D.Ph., M.S. • Beverly Khnie Philip, M.D. • Louis Potters, M.D., F.A.C.R. • Russ Ranallo, M.S. • James V. Rawson, M.D. • Michael Ross, M.D. • Judie S. Snipes, R.N., M.B.A., F.A.C.H.E. • Patricia Spencer-Cisek, M.S., APRN-BC, AOCN® • Kim Allan Williams, M.D., F.A.C.C., F.A.B.C. • Robert M. Zwolak, M.D., Ph.D. F.A.C.S. II. Agenda The agenda for the August 2008 meeting will provide for discussion and comment on the following topics as designated in the Panel's Charter: • Reconfiguring APCs (for example, splitting of APCs, moving Healthcare Common Procedure Coding System (HCPCS) codes from one APC to another and moving HCPCS codes from new technology APCs to clinical APCs). • Evaluating APC weights. • Packaging device and drug costs into APCs: Methodology, effect on APCs, and need for reconfiguring APCs based upon device and drug packaging. • Removing procedures from the inpatient list for payment under the OPPS. • Using single and multiple procedure claims data. • Addressing other APC structure technical issues. Note: The subject matter before the Panel will be limited to these and related topics. Issues related to calculation of the OPPS conversion factor, charge compression, pass-through payments, or wage adjustments are not within the scope of the Panel's purpose. Therefore, these issues will not be considered for presentations and/or comments. There will be no exceptions to this rule. We appreciate your cooperation on this matter. The Panel may use data collected or developed by entities and organizations, other than DHHS and CMS, in conducting its review. We recommend organizations to submit data for the Panel's and CMS staff's review. III. Written Comments and Suggested Agenda Topics Send hardcopy and electronic written comments and suggested agenda topics to the DFO at the address indicated above. The DFO must receive these items by 5 p.m. (e.d.t.), Monday, August 4, 2008. There will be no exceptions. We appreciate your cooperation on this matter. The written comments and suggested agenda topics submitted for the August 2008 APC Panel meeting must fall within the subject categories outlined in the Panel's Charter and as listed in the Agenda section of this notice. IV. Oral Presentations Individuals or organizations wishing to make 5-minute oral presentations must submit hardcopy and electronic versions of their presentations to the DFO by 5 p.m. (e.d.t.), Monday, August 4, 2008, for consideration. The number of oral presentations may be limited by the time available. Oral presentations should not exceed 5 minutes in length for an individual or an organization. The Chair may further limit time allowed for presentations due to the number of oral presentations, if necessary. V. Presenter and Presentation Information All presenters must submit Form CMS-20017 (revised 01/07). Hardcopies are required for oral presentations; however, electronic submissions of Form CMS-20017 are optional. The DFO must receive the following information from those wishing to make oral presentations: • Form CMS-20017 completed with all pertinent information identified on the first page of the presentation. • One hardcopy of presentation. • Electronic copy of presentation. • Personal registration information as described in the Meeting Attendance section below. • Those persons wishing to submit comments only must send hardcopy and electronic versions of their comments, but they are not required to submit Form CMS-20017. VI. Oral Comments In addition to formal oral presentations, there will be opportunity during the meeting for public oral comments, which will be limited to 1 minute for each individual and a total of 3 minutes per organization. VII. Meeting Attendance The meeting is open to the public; however, attendance is limited to space available. Attendance will be determined on a first-come, first-served basis. Persons wishing to attend this meeting, which is located on Federal property, must e-mail the DFO to register in advance no later than 5 p.m. (e.d.t.), Wednesday, August 13, 2008. A confirmation will be sent to the requester(s) by return e-mail. The following personal information must be e-mailed to the DFO by the date and time above: • Name(s) of attendee(s); • Title(s); • Organization; • E-mail address(es); and • Telephone number(s). VIII. Security, Building, and Parking Guidelines Because this meeting will be located on Federal property, for security reasons, any persons wishing to attend this meeting must register by close of business on Wednesday, August 13, 2008. Individuals who have not registered in advance will not be allowed to enter the building to attend the meeting. Seating capacity is limited to the first 250 registrants. The on-site check-in for visitors will be held 30 to 45 minutes before the meeting start time each day. You should allow sufficient time to go through the security checkpoints. It is suggested that you arrive at 7500 Security Boulevard no later than 12:15 p.m. for the 1 p.m. meeting on Wednesday, August 27, 2008. Plan to arrive at the building by 7:15 a.m. on Thursday, August 28, 2008 (and Friday, August 29, 2008—if we have a meeting that day) to ensure that you are able to arrive promptly at the meeting by 8 a.m. All items brought to the building, whether personal or for the purpose of demonstration or to support a presentation, are subject to inspection. Security measures will include inspection of vehicles, inside and out, at the entrance to the grounds. In addition, all persons entering the building must pass through a metal detector. All items brought to CMS, including personal items such as desktops, cell phones, and palm pilots, are subject to physical inspection. The following are the security, building, and parking guidelines: • Persons attending the meeting including presenters must be registered and on the attendance list by the prescribed date. • Individuals who are not registered in advance will not be permitted to enter the building and will be unable to attend the meeting. • Attendees must present photographic identification to the Federal Protective Service or Guard Service personnel before entering the building. • Security measures include inspection of vehicles, inside and out, at the entrance to the grounds. • The main-entrance guards will issue parking permits and instructions upon arrival at the building. • The public may enter the building 30 to 45 minutes before the meeting convenes each day. • All visitors must be escorted in areas other than the lower and first-floor levels in the Central Building. IX. Special Accommodations Individuals requiring sign-language interpretation or other special accommodations must send a request for these services to the DFO by 5 p.m. (e.d.t.), Wednesday, August 13, 2008. (Catalog of Federal Domestic Assistance Program No. 93.773, Medicare—Hospital Insurance; and Program No. 93.774, Medicare—Supplementary Medical Insurance Program) Dated: May 16, 2008. Kerry Weems, Acting Administrator, Centers for Medicare & Medicaid Services. [FR Doc. E8-13828 Filed 6-26-08; 8:45 am] BILLING CODE 4120-01-P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2008-N-0154] Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Good Laboratory Practice Regulations for Nonclinical Studies AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration

(FDA)is announcing that a proposed collection of information has been submitted to the Office of Management and Budget

(GLP)Regulations for Nonclinical Studies—21 CFR Part 58 (OMB Control Number 0910-0119)—Extension Sections 409, 505, 512, and 515 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 348, 355, 360(b), 360(e)) and related statues require manufacturers of food additives, human drugs and biological products, animal drugs, and medical devices to demonstrate the safety and utility of their product by submitting applications to FDA for research or marketing permits. Such applications contain, among other important items, full reports of all studies done to demonstrate product safety in man and/or other animals. In order to ensure adequate quality control for these studies and to provide an adequate degree of consumer protection, the agency issued the GLP regulations. The regulations specify minimum standards for the proper conduct of safety testing and contain sections on facilities, personnel, equipment, standard operating procedures (SOPs), test and control articles, quality assurance, protocol and conduct of a safety study, records and reports, and laboratory disqualification. The GLP regulations contain requirements for the reporting of the results of quality assurance unit inspections, test and control article characterization, testing of mixtures of test and control articles with carriers, and an overall interpretation of nonclinical laboratory studies. The GLP regulations also contain recordkeeping requirements relating to the conduct of safety studies. Such records include the following information:

(1)Personnel job descriptions and summaries of training and experience;

(2)master schedules, protocols and amendments thereto, inspection reports, and SOPs;

(3)equipment inspection, maintenance, calibration, and testing records;

(4)documentation of feed and water analyses and animal treatments;

(5)test article accountability records; and

(6)study documentation and raw data. The information collected under GLP regulations is generally gathered by testing facilities routinely engaged in conducting toxicological studies and is used as part of an application for a research or marketing permit that is voluntarily submitted to FDA by persons desiring to market new products. The facilities that collect this information are typically operated by large entities, e.g., contract laboratories, sponsors of FDA-regulated products, universities, or Government agencies. Failure to include the information in a filing to FDA would mean that agency scientific experts could not make a valid determination of product safety. FDA receives, reviews, and approves hundreds of new product applications each year based on information received. The recordkeeping requirements are necessary to document the proper conduct of a safety study, to assure the quality and integrity of the resulting final report, and to provide adequate proof of the safety of regulated products. FDA conducts onsite audits of records and reports, during its inspections of testing laboratories, to verify reliability of results submitted in applications. The likely respondents collecting this information are contract laboratories, sponsors of FDA-regulated products, universities, or Government agencies. In the **Federal Register** of March 12, 2008 (73 FR 13240), FDA published a 60-day notice requesting public comment on the information collection provisions. No comments were received. **Table 1.—Estimated Annual Reporting Burden** 1 21 CFR Section No. of Respondents Annual Frequency per Response Total Annual Responses Hours per Response Total Hours 58.35(b)(7) 300 60.25 18,075 1 18,075 58.185 300 60.25 18,075 27.65 499,774 Total 517,849 1 There are no capital costs or operating and maintenance costs associated with this collection of information. **Table 2.—Estimated Annual Recordkeeping Burden** 1 21 CFR Section No. of Recordkeepers Annual Frequency per Recordkeeping Total Annual Records Hours per Record Total Hours 58.29(b) 300 20 6,000 .21 1,260 58.35(b)(1) through (b)(6) and

(g)300 62.7 18,810 .13 2,445 58.105(a) and

(b)300 5 1,500 11.8 17,700 58.107(d) 300 1 300 4.25 1,275 58.113(a) 300 15.33 4,599 6.8 31,273 58.120 300 15.38 4,614 32.7 150,878 58.195 300 251.5 75,450 3.9 294,255 Total 786,308 1 There are no capital costs or operating and maintenance costs associated with this collection of information. Dated: June 20, 2008. Jeffrey Shuren, Associate Commissioner for Policy and Planning. [FR Doc. E8-14535 Filed 6-26-08; 8:45 am] BILLING CODE 4160-01-S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2008-N-0172] Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; New Animal Drugs for Investigational Use AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration

(FDA)is announcing that a proposed collection of information has been submitted to the Office of Management and Budget

(1)The name and post office address of the expert or expert organization to whom the drug is shipped; and

(2)the date, quantity, batch or code mark for each shipment for a period of 2 years after such shipment or delivery. Prior to shipping a new animal drug for clinical investigations in animals, a sponsor must submit to FDA a Notice of Claimed Investigational Exemption (NCIE). The NCIE must contain, among other things, the following specific information:

(1)The identity of the new animal drug,

(2)labeling,

(3)a statement of compliance of any non-clinical laboratory studies with good laboratory practices,

(4)the name and address of each clinical investigator,

(5)the approximate number of animals to be treated or amount of new animal drug(s) to be shipped, and

(6)information regarding the use of edible tissues from investigational animals. Part 511 also requires that records be established and maintained to document the distribution and use of the investigational drug to assure that its use is safe and that the distribution is controlled to prevent potential abuse. The agency uses these required records under its Bio-Research Monitoring Program to monitor the validity of the studies submitted to FDA to support new animal drug approval and to assure that proper use of the drug is maintained by the investigator. Investigational new animal drugs are used primarily by the pharmaceutical industry, academic institutions, and the government. Investigators may include individuals from these entities as well as research firms and members of the medical professional. Respondents to this collection of information are investigators who use new animal drugs for investigational purposes. In the **Federal Register** of April 8, 2008 (73 FR 19073), FDA published a 60-day notice requesting public comment on the information collection provisions. No comments were received. **Table 1.—Estimated Annual Reporting Burden** 1 21 CFR Section No. of Respondents Annual Frequency per Response Total Annual Responses Hours per Response Total Hours 511.1(b)(4) 134 7.66 1027 8 8,216 511.1(b)(5) 134 .19 25 140 3,500 511.1(b)(6) 134 .01 2 1 2 511.1(b)(8)

(ii)134 .11 15 20 300 511.1(b)(9) 134 6.7 20 8 160 Total 12,178 1 There are no capital costs or operating and maintenance costs associated with this collection of information. **Table 2.—Estimated Annual Recordkeeping Burden** 1 21 CFR Section No. of Recordkeepers Annual Frequency per Recordkeeping Total Annual Records Hours per Recordkeeper Total Hours 511.1(a)(3) 134 2.96 400 9 3,600 511.1(b)(3) 134 7.66 1,027 1 1,027 511.1(b)(7)(ii) 134 7.46 1,000 3.5 3,500 511.1(b)(8)(i) 134 7.46 1,000 3.5 3,500 Total 11,627 1 There are no capital costs or operating and maintenance costs associated with this collection of information. The burden estimates for reporting requirements, record preparation, and maintenance for this collection of information are based on agency communication with industry. Based on the number of sponsors subject to animal drug user fees, FDA estimates that there are 134 respondents. We use this estimate consistently throughout the table and calculated the “annual frequency per respondent” by dividing the total annual responses by number of respondents. Additional information needed to make final calculations of the total burden hours i.e., the number of respondents, the number of record keepers, the number of NCIEs received, etc., was derived from agency records. Dated: June 23, 2008. Jeffrey Shuren, Associate Commissioner for Policy and Planning. [FR Doc. E8-14653 Filed 6-26-08; 8:45 am] BILLING CODE 4160-01-S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2008-N-0227] Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Medical Device Labeling Regulations AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration

(FDA)is announcing that a proposed collection of information has been submitted to the Office of Management and Budget

(OMB)for review and clearance under the Paperwork Reduction Act of 1995. DATES: Fax written comments on the collection of information by July 28, 2008. ADDRESSES: To ensure that comments on the information collection are received, OMB recommends that written comments be faxed to the Office of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, FAX: 202-395-6974, or e-mailed to *baguilar@omb.eop.gov* . All comments should be identified with the OMB control number 0910-0485. Also include the FDA docket number found in brackets in the heading of this document. FOR FURTHER INFORMATION CONTACT: Denver Presley, Jr., Office of the Chief Information Officer (HFA-250), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-1472. SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has submitted the following proposed collection of information to OMB for review and clearance. Medical Device Labeling Regulations—(OMB Control Number 0910-0485)—Extension Section 502 of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 352), among other things, establishes requirements for the label or labeling of a medical device so that it is not misbranded and subject to a regulatory action. Certain provisions under section 502 of the act require manufacturers, importers, and distributors of medical devices to disclose information about themselves or the devices, on the labels or labeling for the devices. Section 502(b) of the act requires that for packaged devices, the label must bear the name and place of business of the manufacturer, packer, or distributor as well as an accurate statement of the quantity of the contents. Section 502(f) of the act requires that the labeling for a device must contain adequate directions for use. FDA may however, grant an exemption, if the agency determines that the adequate directions for use labeling requirements are not necessary for the particular case, as it relates to protection of the public health. FDA regulations under parts 800, 801, and 809 (21 CFR parts 800, 801, and 809) require disclosure of specific information by manufacturers, importers, and distributors of medical devices about themselves or the devices, on the label or labeling for the devices to health professionals and consumers. FDA issued these regulations under the authority of sections 201, 301, 502, and 701 of the act (21 U.S.C. 321, 331, 352, and 371). Most of the regulations under parts 800, 801, and 809 are derived from requirements of section 502 of the act, which provides in part, that a device shall be misbranded if among other things, its label or labeling fails to bear certain required information concerning the device, is false or misleading in any particular way, or fails to contain adequate directions for use. Reporting Burden Sections 800.10(a)(3) and 800.12(c) require that the label for contact lens cleaning solutions bear a prominent statement alerting consumers of the tamper-resistant feature. Further, § 800.12 requires that packaged contact lens cleaning solutions contain a tamper-resistant feature, to prevent malicious adulteration. Section 800.10(b)(2) requires that the labeling for liquid ophthalmic preparations packed in multiple-dose containers provide information on the duration of use and the necessary warning information to afford adequate protection from contamination during use. Section 801.1 requires that the label for a device in package form, contain the name and place of business of the manufacturer, packer, or distributor. Section 801.5 requires that labeling for a device include information on intended use as defined under § 801.4 and provide adequate directions to assure safe use by the lay consumers. Section 801.61 requires that the principal display panel of an over-the-counter

(OTC)device in package form must bear a statement of the identity of the device. The statement of identity of the device must include the common name of the device followed by an accurate statement of the principal intended actions of the device. Section 801.62 requires that the label for an OTC device in package form, must bear a statement of declaration of the net quantity of contents. The label must express the net quantity in terms of weight, measure, numerical count, or a combination of numerical count and weight, measure, or size. Section 801.109 establishes labeling requirements for prescription devices, in which the label for the device must describe the application or use of the device, and contain a cautionary statement restricting the device for sale by, or on the order of an appropriate professional. For prescription by a licensed practitioner, § 801.110 establishes labeling requirements for a prescription device delivered to the ultimate purchaser or user. The device must be accompanied by labeling bearing the name and address of the licensed practitioner, directions for use, and cautionary statements if any, provided by the order. Section 801.150(e) requires a written agreement between firms involved when a non-sterile device is assembled or packaged with labeling that identifies the final finished device as sterile, for which the device is ultimately introduced into interstate commerce to an establishment or contract manufacturer to be sterilized. When a written agreement complies with the requirements under § 801.150(e), FDA takes no regulatory action against the device as being misbranded or adulterated. In addition, § 801.150(e) requires that each pallet, carton, or other designated unit, be conspicuously marked to show its non-sterile nature when introduced into interstate commerce, and while being held prior to sterilization. Section 801.405(b)(1) provides for labeling requirements for articles, including repair kits, re-liners, pads, and cushions, intended for use in temporary repairs and refitting of dentures for lay persons. Section 801.405(b)(1) also requires that the labeling contain the word “emergency” preceding and modifying each indication-for-use statement for denture repair kits and the word “temporary” preceding and modifying each indication-for-use statement for re-liners, pads, and cushions. Section 801.405(c) provides for labeling requirements that contain essentially the same information described under § 801.405(b)(1). The information is intended to enable a lay person to understand the limitations of using OTC denture repair kits, and denture re-liners, pads, and cushions. Section 801.420(c)(1) requires that manufacturers or distributors of hearing aids develop a user instructional brochure to be provided by the dispenser of the hearing aid to prospective users. The brochure must contain detailed information on the use and maintenance of the hearing aid. Section 801.420(c)(4) establishes requirements that the user instructional brochure or separate labeling, provide for technical data elements useful for selecting, fitting, and checking the performance of a hearing aid. In addition, § 801.420(c)(4) provides for testing requirements to determine that the required data elements must be conducted in accordance with the American National Standards Institute's

(ANSI)“Specification of Hearing Aid Characteristics,” ANSI S3.22-1996 (ASA 70-1996); (Revision of ANSI S3.22-1987), which is incorporated by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. Section 801.421(b) establishes requirement for the hearing aid dispenser to provide prospective users with a copy of the user instructional brochure along with an opportunity to review comments, either orally or by the predominant method of communication used during the sale. Section 801.421(c) establishes requirements for the hearing aid dispenser to provide a copy of the user instructional brochure to the prospective purchaser of any hearing aid upon request or, if the brochure is unavailable, provide the name and address of the manufacturer or distributor from which it may be obtained. Section 801.430(d) establishes labeling requirements for menstrual tampons to provide information on signs, risk factors, and ways to reduce the risk of Toxic Shock Syndrome (TSS). Section 801.430(e)(2) requires menstrual tampon package labels to provide information on the absorbency term based on testing required under § 801.430(f) and an explanation of selecting absorbencies that reduce the risk of contracting TSS. Section 801.430(f) establishes requirements that manufacturers of menstrual tampons devise and follow an ongoing sampling plan for measuring the absorbency of menstrual tampons. Further, manufacturers must use the method and testing parameters described under this section. Section 801.435(b), (c), and (h), establishes requirements for condom labeling to bear an expiration date that is supported by testing that demonstrates the integrity of three random lots of the product. Section 809.10(a) and

(b)establishes requirements that a label for an in vitro diagnostic device and the accompanying labeling (package insert), must contain information identifying its intended use, instructions for use and lot or control number, and source. Section 809.10(d)(1) provides that the labeling requirements for general purpose laboratory reagents may be exempt from the requirements of § 809.10(a) and (b), if the labeling contains information identifying its intended use, instructions for use, lot or control number, and source. Section 809.10(e) provides that the labeling for “Analytic Specific Reagents”

(ASRs)must provide information identifying the quantity or proportion or each reagent ingredient, instructions for use, lot or control number, and source. Section 809.10(f) provides that, the labeling for OTC test sample collection systems for drugs of abuse must include information on the intended use, specimen collection instructions, identification system, and information about use of the test results. In addition, § 809.10(f) requires that this information be in a language appropriate for the intended users. Section 809.30(d) requires that advertising and promotional materials for ASRs include the identity and purity of the ASR and the identity of the analyte. Recordkeeping Burden Section 801.150(a)(2) establishes recordkeeping requirements for re-processors, re-labelers, or re-packagers to retain a copy of the agreement containing the specifications for the processing, labeling, or repacking of the device for 2 years after the shipment or delivery of the device. Section 801.150(a)(2) also requires that the subject respondents make copies of this agreement available for inspection at any reasonable hour to any officer or employee of the Department of Health and Human Services (DHHS), upon their request. Section 801.421(d) establishes requirements for hearing aid dispensers to retain copies of all physician statements or any waivers of medical evaluation for 3 years after dispensing the hearing aid. Section 801.410(e) requires copies of invoices, shipping documents, and records of sale or distribution of all impact resistant lenses, including finished eyeglasses and sunglasses, be maintained for 3 years by the retailer and made available upon request by any officer or employee of the FDA or by any other officer or employee acting on behalf of the Secretary of Health and Human Services. Section 801.410(f) requires that the results of impact tests and description of the test method and apparatus be retained for a period of 3 years. Section 801.421(d) requires hearing aid dispensers to retain a copy of any written statement from a physician required under § 801.421(a)(1), or any written statement waiving medical evaluation required under § 801.421(a)(2)(iii) for 3 years after the dispensing the hearing aid. Section 801.435(g) requires latex condom manufacturers to document and provide, upon request, an appropriate justification for the application of the testing data from one product on any variation of that product to support expiration dating in the user labeling. In the **Federal Register** of April 23, 2008 (73 FR 21959), FDA published a 60-day notice requesting public comment on the information collection provisions. No comments were received. **Table 1.—Estimated Annual Reporting Burden** 1 21 CFR Section No. of Respondents Annual Frequency per Response Total Annual Responses Hours per Response Total Hours 800.10(a)(3) and 800.12(c) 4 10 40 1 40 800.10(b)(2) 4 10 40 40 1,600 801.1 30,000 3.5 105,000 0.1 10,500 801.5 5,000 3.5 17,500 22.35 391,125 801.61 5,000 3.5 17,500 1 17,500 801.62 1,000 5 5,000 1 5,000 801.109 18,000 3.5 63,000 17.77 1,119,510 801.110 10,000 50 500,000 0.25 125,000 801.150(e) 2 1 2 0.50 1 801.405(b)(1) and

(c)40 1 40 4 160 801.420(c)(1) 275 5 1,375 40 55,000 801.420(c)(4) 275 5 1,375 80 110,000 801.421(b) 10,000 160 1,600,000 0.30 480,000 801.421(c) 10,000 5 50,000 0.17 8,500 801.430(d) and (e)(2) 8 5 40 2 80 801.430(f) 8 5 40 80 3,200 801.435(b), (c), and

(h)135 1 135 96 12,960 809.10(a) and

(b)1,700 6 10,200 80 816,000 809.10(d)(1) 300 2 600 40 24,000 809.10(e) 300 25 7,500 1 7,500 809.10(f) 20 1 20 100 2,000 809.30(d) 300 25 7,500 1 7,500 Total 3,197,416 1 There are no capital costs or operating and maintenance costs associated with this information collection. **Table 2.—Estimated Annual Recordkeeping Burden** 1 21 CFR Section No. of Recordkeepers Annual Frequency per Recordkeeping Total Annual Records Hours per Record Total Hours 801.150(a)(2) 57 1 57 0.50 28 801.410(e) and

(f)30 924,100 27,723,000 .0008 22,178 801.421(d) 10,000 160 1,600,000 0.25 400,000 801.435(g) 4 3 12 40 480 Total Hours 422,686 1. There are no capital costs or operating and maintenance costs associated with this information collection. This regulation also refers to previously approved collections of information found in FDA regulations. The collections of information under §§ 800.12(d) and 801.437(i) have been approved under OMB control number 0910-0183; the collections of information under § 800.12(e) have been approved under OMB control number 0910-0231; and the collections of information under § 801.435(g) have been approved under OMB control number 0910-0073. Further, FDA concludes that labeling statements under §§ 801.63; 801.405(b)(2) and (b)(3); 801.420(c)(2) and (c)(3); 801.430(c) and(e)(1); 801.433; 801.437(d) through (g); 809.30(d)(2), (d)(3), and

(e)do not constitute a “collection of information” under the PRA. Rather, these labeling statements are “public disclosure” of information originally supplied by the Federal Government to the recipient for the purpose of disclosure to the public” (5 CFR 1320.3(c)(2)). Reporting These estimates are based on FDA's registration and listing database for medical device establishments, agency communications with industry, and FDA's knowledge of, and experience with device labeling. Recordkeeping These estimates are based on FDA's registration and listing database for medical device establishments, agency communications with industry, and FDA's knowledge of and experience with device labeling. In addition, the Vision Council of America provided the growth rate used to estimate the burden under § 801.410(e) and (f). FDA is correcting its recordkeeping burden estimate for § 801.410(e) and (f). In the **Federal Register** of April 23, 2008, the recordkeeping burden estimate in Table 2 was overestimated as 11,935,028 hours. The corrected recordkeeping burden estimate for this proposed collection is 422,686 hours. The correction for the recordkeeping burden estimate was necessary due to two errors. First, FDA incorrectly gave an estimate of 0.25 hours per recordkeeper for § 801.410(e) and (f). The corrected estimate is 0.0008 hours per recordkeeper. Secondly, FDA inadvertently duplicated the recordkeeping burden for these sections. This regulation also refers to previously approved collections of information found in FDA regulations. The collections of information under §§ 800.12(d) and 801.437(i) have been approved under OMB control number 0910-0183; and the collections of information under § 800.12(e) have been approved under OMB control number 0910-0231. The information collection requirements under §§ 801.22, 801.63, 801.405(b)(2) and (b)(3), 801.420(c)(2) and (c)(3), 801.430(c) and (e)(1), 801.433, 801.437(d) through (g); 809.30(d)(2), (d)(3), and

(e)are not considered information collection because the public information is originally supplied by the Federal Government to the recipient for the purpose of disclosure to the public (5 CFR 1320.3(c)(2)). We have not estimated a burden for information that is disclosed to third parties, because it is a “usual and customary” part of a medical device manufacturer, distributor, or importer's normal business activities. Nor have we estimated a burden for time that is spent designing labels to improve the format or presentation. Dated: June 24, 2008. Jeffrey Shuren, Associate Commissioner for Policy and Planning. [FR Doc. E8-14658 Filed 6-26-08; 8:45 am] BILLING CODE 4160-01-S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2008-N-0168] Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Electronic Records; Electronic Signatures AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration

(FDA)is announcing that a proposed collection of information has been submitted to the Office of Management and Budget

(1)§ 11.10 specifies procedures and controls for persons who use closed systems to create, modify, maintain, or transmit electronic records;

(2)§ 11.30 specifies procedures and controls for persons who use open systems to create, modify, maintain, or transmit electronic records;

(3)§ 11.50 specifies procedures and controls for persons who use electronic signatures; and

(4)§ 11.300 specifies controls to ensure the security and integrity of electronic signatures based upon use of identification codes in combination with passwords. The reporting provision (§ 11.100) requires persons to certify in writing to FDA that they will regard electronic signatures used in their systems as the legally binding equivalent of traditional handwritten signatures. The burden created by the information collection provision of this regulation is a one-time burden associated with the creation of standard operating procedures, validation, and certification. The agency anticipates the use of electronic media will substantially reduce the paperwork burden associated with maintaining FDA required records. The respondents will be businesses and other for-profit organizations, State or local governments, Federal agencies, and nonprofit institutions. In the **Federal Register** of March 26, 2008 (73 FR 16017), FDA published a 60-day notice requesting public comment on the information collection provisions. No comments were received. **Table 1.—Estimated Annual Reporting Burden** 1 21 CFR Section No. of Respondents Annual Frequency per Response Total Annual Responses Hours per Response Total Hours 11.100 4,500 1 4,500 1 4,500 1 There are no capital costs or operating and maintenance costs associated with this collection of information. **Table 2.—Estimated Annual Recordkeeping Burden** 1 21 CFR Section No. of Recordkeepers Annual Frequency per Recordkeeping Total Annual Records Hours per Record Total Hours 11.10 2,500 1 2,500 20 50,000 11.30 2,500 1 2,500 20 50,000 11.50 4,500 1 4,500 20 90,000 11.300 4,500 1 4,500 20 90,000 Total 280,000 1 There are no capital costs or operating and maintenance costs associated with this collection of information. Dated: June 23, 2008. Jeffrey Shuren, Associate Commissioner for Policy and Planning. [FR Doc. E8-14659 Filed 6-26-08; 8:45 am] BILLING CODE 4160-01-S DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Center for Scientific Review; Notice of Closed Meetings Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. Appendix 2), notice is hereby given of the following meetings. The meetings will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy. *Name of Committee:* Center for Scientific Review Special Emphasis Panel, Core Instrumentation. *Date:* July 14-15, 2008. *Time:* 8 a.m. to 4:30 p.m. *Agenda:* To review and evaluate grant applications. *Place:* National Institutes of Health, 6701 Rockledge Drive, Bethesda, MD 20892 (Virtual Meeting). *Contact Person:* Joseph D. Mosca, PhD, Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Rm. 5158, MSC 7808, Bethesda, MD 20892, 301-435-2344, *moscajos@csr.nih.gov* . This notice is being published less than 15 days prior to the meeting due to the timing limitations imposed by the review and funding cycle. *Name of Committee:* Center for Scientific Review Special Emphasis Panel, Dermatology/Rheumatology Small Business, Special Emphasis Panel. *Date:* July 18-22, 2008. *Time:* 8 a.m. to 5 p.m. *Agenda:* To review and evaluate grant applications. *Place:* National Institutes of Health, 6701 Rockledge Drive, Bethesda, MD 20892 (Virtual Meeting). *Contact Person:* Daniel F. McDonald, PhD, Scientific Review Officer, Chief, MOSS IRG, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 4214, MSC 7814, Bethesda, MD 20892,

(301)435-1215, *mcdonald@csr.nih.gov* . This notice is being published less than 15 days prior to the meeting due to the timing limitations imposed by the review and funding cycle. *Name of Committee:* Center for Scientific Review Special Emphasis Panel, Cancer Biology. *Date:* July 18, 2008. *Time:* 1 p.m. to 3 p.m. *Agenda:* To review and evaluate grant applications. *Place:* National Institutes of Health, 6701 Rockledge Drive, Bethesda, MD 20892 (Telephone Conference Call). *Contact Person:* Denise R. Shaw, PhD, Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 6158, MSC 7804, Bethesda, MD 20892, 301-435-0198, *shawkath@mail.nih.gov* . This notice is being published less than 15 days prior to the meeting due to the timing limitations imposed by the review and funding cycle. *Name of Committee:* Center for Scientific Review Special Emphasis Panel, Discovery of Novel Epigenetic Marks. *Date:* July 25, 2008. *Time:* 8 a.m. to 9 p.m. *Agenda:* To review and evaluate grant applications. *Place:* Hilton Alexandria Old Town, 1767 King Street, Alexandria, VA 22314. *Contact Person:* Richard Panniers, PhD, Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 2212, MSC 7890, Bethesda, MD 20892,

(301)435-1741, *pannierr@csr.nih.gov* . *Name of Committee:* Center for Scientific Review Special Emphasis Panel, Sharing Data and Tools and Data Ontologies. *Date:* July 28, 2008. *Time:* 8 a.m. to 5 p.m. *Agenda:* To review and evaluate grant applications. *Place:* Hyatt Regency Bethesda, One Bethesda Metro Center, 7400 Wisconsin Avenue, Bethesda, MD 20814. *Contact Person:* Alexander Gubin, PhD, Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Rm. 5144, MSC 7812, Bethesda, MD 20892, 301-435-2902, *gubina@csr.nih.gov* . *Name of Committee:* Center for Scientific Review Special Emphasis Panel, Drug Abuse Aspects of HIV/AIDS. *Date:* July 28, 2008. *Time:* 8 a.m. to 6 p.m. *Agenda:* To review and evaluate grant applications. *Place:* National Institutes of Health, 6701 Rockledge Drive, Bethesda, MD 20892 (Virtual Meeting). *Contact Person:* Mark P. Rubert, PhD, Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 5218, MSC 7852, Bethesda, MD 20892, 301-435-1775, *rubertm@csr.nih.gov* . *Name of Committee:* Center for Scientific Review Special Emphasis Panel, Development of Assays for High Throughput Screening. *Date:* July 30, 2008. *Time:* 8 a.m. to 6:30 p.m. *Agenda:* To review and evaluate grant applications. *Place:* Bethesda Marriott, 5151 Pooks Hill Road, Bethesda, MD 20814. *Contact Person:* James J. Li, PhD, Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 5148, MSC 7849, Bethesda, MD 20892, 301-435-2417, *lijames@csr.nih.gov* . *Name of Committee:* Center for Scientific Review Special Emphasis Panel, Electrochemistry, Spectroscopy, and Sensor Development Panel. *Date:* August 5, 2008. *Time:* 2 p.m. to 5 p.m. *Agenda:* To review and evaluate grant applications. *Place:* National Institutes of Health, 6701 Rockledge Drive, Bethesda, MD 20892 (Telephone Conference Call). *Contact Person:* Vonda K. Smith, PhD, Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 4148, MSC 7806, Bethesda, MD 20892, 301-435-1789, *smithvo@csr.nih.gov* . (Catalogue of Federal Domestic Assistance Program Nos. 93.306, Comparative Medicine; 93.333, Clinical Research, 93.306, 93.333, 93.337, 93.393-93.396, 93.837-93.844, 93.846-93.878, 93.892, 93.893, National Institutes of Health, HHS) Dated: June 19, 2008. Jennifer Spaeth, Director, Office of Federal Advisory Committee Policy. [FR Doc. E8-14600 Filed 6-26-08; 8:45 am] BILLING CODE 4140-01-M DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Institute on Drug Abuse; Notice of Closed Meeting Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. Appendix 2), notice is hereby given of the following meeting. The meeting will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy. *Name of Committee:* National Institute on Drug Abuse Special Emphasis Panel, Conference Grant Review Committee. *Date:* July 18, 2008. *Time:* 1 p.m. to 5 p.m. *Agenda:* To review and evaluate grant applications. *Place:* National Institutes of Health, 6101 Executive Boulevard, Rockville, MD 20852 (Virtual Meeting). *Contact Person:* Mark R. Green, PhD, Deputy Director, Office of Extramural Affairs, National Institute on Drug Abuse, NIH, DHHS, Room 220, MSC 8401, 6101 Executive Boulevard, Bethesda, MD 20892-8401,

(301)435-1431, *mgreen1@nida.nih.gov.* (Catalogue of Federal Domestic Assistance Program Nos. 93.279, Drug Abuse and Addiction Research Programs, National Institutes of Health, HHS) Dated: June 19, 2008 Jennifer Spaeth, Director, Office of Federal Advisory Committee Policy. [FR Doc. E8-14599 Filed 6-26-08; 8:45 am] BILLING CODE 4140-01-M DEPARTMENT OF HEALTH AND HUMAN SERVICES Substance Abuse and Mental Health Services Administration Agency Information Collection Activities: Submission for OMB Review; Comment Request Periodically, the Substance Abuse and Mental Health Services Administration (SAMHSA) will publish a summary of information collection requests under OMB review, in compliance with the Paperwork Reduction Act (44 U.S.C. Chapter 35). To request a copy of these documents, call the SAMHSA Reports Clearance Officer on

(240)276-1243. Project: 2009 National Survey on Drug Use and Health—(OMB No. 0930-0110)—Revision The National Survey on Drug Use and Health (NSDUH), formerly the National Household Survey on Drug Abuse (NHSDA) is a survey of the civilian, non-institutionalized population of the United States 12 years old and older. The data are used to determine the prevalence of use of tobacco products, alcohol, illicit substances, and illicit use of prescription drugs. The results are used by SAMHSA, ONDCP, Federal government agencies, and other organizations and researchers to establish policy, direct program activities, and better allocate resources. In the 2009 NSDUH, one scale measuring impairment from mental health issues will be adopted. The decision to adopt either the Sheehan or the WHO-DAS is currently being evaluated in the 2008 NSDUH by using the SCID-I/NP as a follow-up interview with a subsample of respondents. Based upon a substantive review of questions in the Youth Mental Health Services Utilization module, some additions and deletions will be made to this section to more specifically depict the types of providers and service delivery sites for youth mental health services. The remaining modular components of the questionnaire will remain essentially unchanged except for minor modifications to wording. As with all NSDUH/NHSDA surveys conducted since 1999, the sample size of the survey for 2009 will be sufficient to permit prevalence estimates for each of the fifty states and the District of Columbia. The total annual burden estimate is shown below: No. of responses Responses per respondent Average burden per response (hr.) Total burden

(hrs)Household Screening 190,800 1 .083 15,836 Interview 67,500 1 1.0 67,500 Clinical Follow-up Certification 30 1 1.0 30 Clinical Follow-up Interview 500 1 1.0 500 Screening Verification 5,400 1 0.067 362 Interview Verification 10,125 1 0.067 678 190,800 84,906 Written comments and recommendations concerning the proposed information collection should be sent by July 28, 2008 to: SAMHSA Desk Officer, Human Resources and Housing Branch, Office of Management and Budget, New Executive Office Building, Room 10235, Washington, DC 20503; due to potential delays in OMB's receipt and processing of mail sent through the U.S. Postal Service, respondents are encouraged to submit comments by fax to: 202-395-6974. Dated: June 20, 2008. Elaine Parry, Acting Director, Office of Program Services. [FR Doc. E8-14578 Filed 6-26-08; 8:45 am] BILLING CODE 4162-20-P DEPARTMENT OF HOMELAND SECURITY [Docket No. DHS-2008-0049] Science and Technology Directorate; Submission for Review; Information Collection Request for the DHS S&T Biodefense Knowledge Center Expert Database; Correction AGENCY: Science and Technology Directorate, DHS. ACTION: 30-day Notice and request for comment; Correction. SUMMARY: The Department of Homeland Security

(DHS)published a document in the **Federal Register** on May 22, 2008, concerning a 30-day notice and request for comment on the Biodefense Knowledge Center Expert Database. The document contained the incorrect name of the Biodefense Knowledge Center, incorrectly written as Bio-Knowledge Center, as well as incorrect information in the summary, supplementary information, and overview of the information collection portion of the notice. FOR FURTHER INFORMATION CONTACT: Dave Shepherd, 202-254-5897. Corrections In the **Federal Register** of May 22, 2008, in FR Doc. E8-11454, on page 29773, in the second column, correct the SUMMARY caption to read: The Department of Homeland Security

(DHS)invites the general public to comment on a new data collection form for the Biodefense Knowledge Center Expert Database: Subject Matter Expert

(SME)Registration Form (DHS Form 10043). The Biodefense Knowledge Center Database will collect SME information in order to understand who can provide scientific expertise for peer review of classified life science programs. In addition, the directory will make it easier to identify scientific specialty areas for which there is a shortage of SMEs with appropriate security clearances. SME contact information, scientific expertise, and level of education will be collected electronically through a web portal currently being developed by DHS S&T. The SME information will be shared with U.S. Government program managers who have a legitimate need to identify life sciences SMEs. Cleared SMEs are necessary to accomplish scientific reviews and attend topical meetings. This notice and request for comments is required by the Paperwork Reduction Act of 1995 (Pub. Law 104-13, 44 U.S.C. chapter 35). Previously, a 60-day notice was published in the **Federal Register** on March 14, 2008. In the **Federal Register** of May 22, 2008, in FR Doc. E8-11454, on page 29773, in the third column, correct the first sentence of the SUPPLEMENTARY INFORMATION caption to read: The National Counterproliferation Center has identified the need for a comprehensive and readily available list of life science SMEs who have security clearance status. In the **Federal Register** of May 22, 2008, in FR Doc. E8-11454, on page 29774, in the first column, correct the last sentence of the third bullet under the “ *Overview of this Information Collection* ” caption to read: The SME information will be shared with U.S. Government program managers who have a legitimate need to identify life science SMEs. Dated: June 16, 2008. Kenneth D. Rogers, Chief Information Officer, Science and Technology Directorate. [FR Doc. E8-14643 Filed 6-26-08; 8:45 am] BILLING CODE 4410-10-P DEPARTMENT OF HOMELAND SECURITY Science and Technology Directorate; Notice of Availability

(NOA)for the Draft Environmental Impact Statement

(DEIS)for the proposed National Bio and Agro-Defense Facility

(NBAF)AGENCY: Science and Technology Directorate (Office of National Laboratories within the Office of Research), DHS. ACTION: Notice of Availability of the Draft Environmental Impact Statement for the National Bio and Agro-Defense Facility (NBAF). SUMMARY: The Proposed Action to site, build, and construct the National Bio and Agro-Defense Facility

(NBAF)would allow researchers to study foreign animal diseases

(FAD)and zoonotic diseases (transmitted from animals to humans) for basic research, improving diagnostic tests, and developing effective vaccines and other countermeasures such as antiviral therapies. DHS anticipates that the NBAF would focus biosafety level 3 agricultural (BSL-3Ag) research on African swine fever, classical swine fever, contagious bovine pleuropneumonia, foot and mouth disease (FMD), Japanese encephalitis, and Rift Valley fever (RVF), as well as BSL-4 research on Hendra and Nipah viruses. The NBAF would be approximately 500,000 to 520,000 square feet and consist of a primary laboratory building with a vaccine development laboratory adjacent or contiguous to it. The primary research building would contain the BSL-2, BSL-3E, BSL-3Ag, and BSL-4 laboratories with their associated support spaces. The other laboratory building would be a current good manufacturing practice

(cGMP)laboratory adjacent to the primary research laboratory. The cGMP laboratory would be needed for vaccine candidate production. Other out buildings would be considered ancillary and necessary to support operation of the NBAF. Those buildings would include a guardhouse, transshipping facility, and central utility plant. DATES: The comment period for the DEIS will end 60 days after publication of the NOA in the **Federal Register** by the U.S. Environmental Protection Agency. ADDRESSES: To obtain a copy of the DEIS, ask questions, or submit written comments, contact Department of Homeland Security; Science and Technology Directorate; Mr. James V. Johnson: Mail Stop #2100; 245 Murray Lane, SW., Building 410; Washington, DC 20528. FOR FURTHER INFORMATION CONTACT: All comments, both oral and written, received during this 60 day public comment period will be given equal consideration when finalizing the NBAF EIS. Comments may be submitted at the public meetings or online at *http://www.dhs.gov/nbaf* [click on Environmental Impact Statement]. You may also call: Toll-free fax 1-866-508-NBAF (6223); Toll-free voice mail; or 1-866-501-NBAF (6223). SUPPLEMENTARY INFORMATION: Consultation between DHS and the United States Department of Agriculture

(USDA)on a coordinated biodefense strategy called for in Homeland Security Presidential Directives 9 and 10 have revealed a gap that must be filled by an integrated research, development, test, and evaluation (RD&T) infrastructure for combating bio and agro terrorism threats. DHS S&T is responsible for filling this gap in a safe, secure, and environmentally sound manner. The proposed NBAF is envisioned to provide the nation with the first integrated agricultural zoonotic disease and animal health RD&T facility with the capability to address threats from high consequence zoonotic disease agents and foreign animal diseases. DHS intends to select a single site for the construction of the NBAF. The NBAF DEIS analyzes six action alternatives as well as the No Action Alternative. The six action alternatives include construction and operation of the proposed NBAF at one of the following six site alternatives:

(1)South Milledge Avenue Site; Athens, Georgia;

(2)Manhattan Campus Site; Manhattan, Kansas;

(3)Flora Industrial Park Site; Flora, Mississippi;

(4)Plum Island Site; Plum Island, New York;

(5)Umstead Research Farm Site; Butner, North Carolina; and

(6)Texas Research Park Site; San Antonio, Texas. Under the No Action Alternative, the NBAF would not be constructed and DHS would continue to use the Plum Island Animal Disease Center with necessary investments in facility upgrades, replacements, and repairs so that it could continue to operate at its current capability, but not the expanded mission requirements associated with the NBAF. DHS has not identified a Preferred Alternative. The evaluation conducted during the NEPA process will be used in conjunction with other factors to assist DHS in selecting the proposed federal action. Additional studies are being performed concurrently with this EIS that will provide important decision-making information. Results of these studies will be used in the development of the Final EIS and the Record of Decision (ROD). In order to make these decisions and formulate the ROD, the following reports will be considered:

(1)EIS,

(2)Threat and Risk Assessment,

(3)Site Cost Analysis,

(4)Site Characterization Study,

(5)Plum Island Facility Closure and Transition Cost Study; and

(6)Prior analysis of the alternative sites against DHS's site selection evaluation criteria. The information contained in these reports will assist DHS and USDA, a major stakeholder in this endeavor, in considering the protection of the public and the environment while meeting the need for a modern, high-security BSL-3Ag and BSL-4 research facility with the capabilities needed to address potential threats to our agriculture. Comments on the Draft EIS received during the 60-day public comment period will be considered in preparing the Final EIS. Public meetings to comment on the NBAF DEIS will be held at various locations near each alternative site location and in Washington, DC. Notification of the times and locations for the public meetings will be published in local news media and on the DHS Web site, *http://www.dhs.gov/nbaf* [click on Environmental Impact Statement]. The dates of the public review meetings are listed below. *The Public Meeting dates are:* 1. Thursday, July 24, 2008, from 12:30 p.m. to 4:30 p.m. Washington, DC, Grand Hyatt Washington, 1000 H Street, NW., Washington, DC 20001. 2. Tuesday, July 29, 2008, from 12:30 p.m. to 4:30 p.m. and from 6 p.m. to 10 p.m. Butner, NC, Butner-Stem Middle School, 501 East D Street, Butner, NC 27509. 3. Thursday, July 31, 2008, from 12:30 p.m. to 4:30 p.m. and from 6 p.m. to 10 p.m. Manhattan, KS, Kansas State University, K-State Student Union, Manhattan, KS 66506. 4. Tuesday, August 5, 2008, from 12:30 p.m. to 4:30 p.m. and from 6 p.m. to 10 p.m. Flora, MS, First Baptist Church, Christian Life Center, 121 Center Street, Flora, MS 39071. 5. Thursday, August 7, 2008, from 12:30 p.m. to 4:30 p.m. and from 6 p.m. to 10 p.m. San Antonio, TX, Radisson Hill Country Resort, 9800 Westover Hills Boulevard, San Antonio, TX 78251. 6. Monday, August 11, 2008, from 6 p.m. to 10 p.m. Old Saybrook, CT, Saybrook Point Inn, Two Bridge Street, Old Saybrook, CT 06475. 7. Tuesday, August 12, 2008, from 6 p.m. to 10 p.m. Greenport, NY, Greenport School, 720 Front Street, Greenport, NY 11944. 8. Thursday, August 14, 2008, from 12:30 p.m. to 4:30 p.m. and from 6 p.m. to 10 p.m. Athens, GA, the University of Georgia, Center for Continuing Education, 1197 South Lumpkin Street, Athens, GA 30602. *Copies of the NBAF DEIS are available for review at the following locations:* Georgia University of Georgia Main Library, 320 South Jackson Street, Athens, GA 30602. Oconee County Library, 1080 Experiment Station Road, P.O. Box 837, Watkinsville, GA 30677. Kansas Manhattan Public Library, 629 Poyntz Avenue, Manhattan, KS 66502. Hale Library, Kansas State University, Manhattan, KS 66506. Mississippi City of Flora Library, 144 Clark Street, Flora, MS 39071. New York Site Acton Public Library, 60 Old Boston Post Road, Old Saybrook, CT 06475. Southold Free Library, 53705 Main Road, Southold, NY 11971. North Carolina Richard H. Thornton Library, 210 Main Street, Oxford, NC 27565-0339. South Branch Library, 1547 South Campus Drive, Creedmoor, NC 27522. Texas Central Library, 600 Soledad, San Antonio, TX 78205. Authority: 42 U.S.C. 4321-4347 (National Environmental Policy Act). Dated: June 20, 2008. Bruce Knight, Under Secretary, Marketing and Regulatory Programs, USDA. Jay M. Cohen, Under Secretary, Science & Technology, DHS. [FR Doc. E8-14526 Filed 6-26-08; 8:45 am] BILLING CODE 4410-10-P DEPARTMENT OF HOMELAND SECURITY U.S. Citizenship and Immigration Services Agency Information Collection Activities: Form N-648, Revision of a Currently Approved Information Collection; Comment Request ACTION: 30-Day Notice of Information Collection Under Review: Form N-648, Medical Certification for Disability Exceptions; OMB Control No. 1615-0060. The Department of Homeland Security, U.S. Citizenship and Immigration Services (USCIS) submitted the following information collection request to the Office of Management and Budget

(OMB)for review and clearance in accordance with the Paperwork Reduction Act of 1995. The information collection was previously published in the **Federal Register** on April 14, 2008, at 73 FR 20058 allowing for a 60-day public comment period. USCIS received four comments for this information collection. The comments will be addressed in the supporting statement. The purpose of this notice is to allow an additional 30 days for public comments. Comments are encouraged and will be accepted until July 28, 2008. This process is conducted in accordance with 5 CFR 1320.10. Written comments and/or suggestions regarding the item(s) contained in this notice, especially regarding the estimated public burden and associated response time, should be directed to the Department of Homeland Security (DHS), and to the Office of Management and Budget

(OMB)USCIS Desk Officer. Interested persons are invited to submit written comments on the proposed information collection to the Office of Information and Regulatory Affairs, Office of Management and Budget. Comments should be addressed to OMB Desk Officer, for U.S. Citizenship and Immigration Services, Department of Homeland Security, and sent via electronic mail to *oira_submission@omb.eop.gov* or faxed to

(202)395-6974. When submitting comments by e-mail, please make sure to add OMB Control Number 1615-0060. Written comments and suggestions from the public and affected agencies should address one or more of the following four points:

(1)Evaluate whether the collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility;

(2)Evaluate the accuracy of the agency's estimate of the burden of the collection of information, including the validity of the methodology and assumptions used;

(3)Enhance the quality, utility, and clarity of the information to be collected; and

(4)Minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques, or other forms of information technology, *e.g.* , permitting electronic submission of responses. Overview of This Information Collection

(1)*Type of Information Collection:* Revision of a currently approved information collection.

(2)*Title of the Form/Collection:* Medical Certification for Disability Exceptions.

(3)*Agency form number, if any, and the applicable component of the Department of Homeland Security sponsoring the collection:* Form N-648. U.S. Citizenship and Immigration Services.

(4)*Affected public who will be asked or required to respond, as well as a brief abstract: Primary:* Individuals and households. USCIS uses the Form N-648 medical certification issued by the licensed medical professional to substantiate a claim for an exception to the requirements of section 312(a) of the Act.

(5)*An estimate of the total number of respondents and the amount of time estimated for an average respondent to respond:* 20,000 responses at 2 hours per response.

(6)*An estimate of the total public burden (in hours) associated with the collection:* 40,000 annual burden hours. If you have additional comments, suggestions, or need a copy of the proposed information collection instrument with instructions, or additional information, please visit: *http://www.regulations.gov/search/index.jsp.* If additional information is required contact: USCIS, Regulatory Management Division, 111 Massachusetts Avenue, Suite 3008, Washington, DC 20529,

(202)272-8377. Dated: June 24, 2008. Stephen Tarragon, Acting Chief, Regulatory Management Division, U.S. Citizenship and Immigration Services, Department of Homeland Security. [FR Doc. E8-14576 Filed 6-26-08; 8:45 am] BILLING CODE 9111-97-P DEPARTMENT OF HOMELAND SECURITY U.S. Customs and Border Protection Proposed Collection; Comment Request; Foreign Trade Zone Annual Reconciliation Certification and Record Keeping Requirement AGENCY: U.S. Customs and Border Protection (CBP), Department of Homeland Security. ACTION: 60-Day Notice and request for comments; Extension of existing collection of information: 1651-0051. SUMMARY: The Department of Homeland Security, as part of its continuing effort to reduce paperwork and respondent burden, CBP invites the general public and other Federal agencies to comment on an information collection requirement concerning the Foreign Trade Zone Annual Reconciliation Certification and Record Keeping Requirement. This request for comment is being made pursuant to the Paperwork Reduction Act of 1995 (Pub. L. 104-13; 44 U.S.C. 3505(c)(2)). DATES: Written comments should be received on or before August 26, 2008, to be assured of consideration. ADDRESSES: Direct all written comments to U.S. Customs and Border Protection, Attn.: Tracey Denning, 1300 Pennsylvania Avenue, NW., Room 3.2C, Washington, DC 20229. FOR FURTHER INFORMATION CONTACT: Requests for additional information should be directed to U.S. Customs and Border Protection, Attn.: Tracey Denning, 1300 Pennsylvania Avenue, NW., Room 3.2C, Washington, DC 20229, Tel.

(202)344-1429. SUPPLEMENTARY INFORMATION: CBP invites the general public and other Federal agencies to comment on proposed and/or continuing information collections pursuant to the Paperwork Reduction Act of 1995 (Pub. L. 104-13; 44 U.S.C. 3505(c)(2)). The comments should address the accuracy of the burden estimates and ways to minimize the burden including the use of automated collection techniques or the use of other forms of information technology, as well as other relevant aspects of the information collection. The comments that are submitted will be summarized and included in the CBP request for Office of Management and Budget

(OMB)approval. All comments will become a matter of public record. In this document CBP is soliciting comments concerning the following information collection: *Title:* Foreign Trade Zone Annual Reconciliation Certification and Record Keeping Requirement. *OMB Number:* 1651-0051. *Form Number:* None. *Abstract:* Each Foreign Trade Zone Operator will be responsible for maintaining its inventory control in compliance with statue and regulations. The operator will furnish CBP an annual certification of their compliance. *Current Actions:* There are no changes to the information collection. This submission is being submitted to extend the expiration date. *Type of Review:* Extension (without change). *Affected Public:* Business or other for-profit institutions. *Estimated Number of Respondents:* 260. *Estimated Time per Respondent:* 45 minutes. *Estimated Total Annual Burden Hours:* 195. Dated: June 23, 2008. Tracey Denning, Agency Clearance Officer, Customs and Border Protection. [FR Doc. E8-14559 Filed 6-26-08; 8:45 am] BILLING CODE 9111-14-P DEPARTMENT OF HOMELAND SECURITY U.S. Customs and Border Protection Proposed Collection; Comment Request; Crew's Effects Declaration AGENCY: U.S. Customs and Border Protection (CBP), Department of Homeland Security. ACTION: 60-Day Notice and request for comments; Extension of existing collection of information: 1651-0020. SUMMARY: As part of its continuing effort to reduce paperwork and respondent burden, CBP invites the general public and other Federal agencies to comment on an information collection requirement concerning the Crew's Effects Declaration. This request for comment is being made pursuant to the Paperwork Reduction Act of 1995 (Pub. L. 104-13; 44 U.S.C. 3505(c)(2)). DATES: Written comments should be received on or before August 26, 2008, to be assured of consideration. ADDRESSES: Direct all written comments to U.S. Customs and Border Protection, Attn.: Tracey Denning, 1300 Pennsylvania Avenue, NW., Room 3.2C, Washington, DC 20229. FOR FURTHER INFORMATION CONTACT: Requests for additional information should be directed to U.S. Customs and Border Protection, Attn.: Tracey Denning, 1300 Pennsylvania Avenue, NW., Room 3.2C, Washington, DC 20229, Tel.

(OMB)approval. All comments will become a matter of public record. In this document CBP is soliciting comments concerning the following information collection: *Title:* Crew's Effects Declaration. *OMB Number:* 1651-0020. *Form Number:* CBP Form-1304. *Abstract:* CBP Form-1304 contains a list of crew's effects that are accompanying them on the trip, which are required to be manifested, and also the statement of the master of the vessel attesting to the truthfulness of the merchandise being carried on board the vessel as crew's effects. Current Actions: There are no changes to the information collection. This submission is being submitted to extend the expiration date. *Type of Review:* Extension (without change). *Affected Public:* Business or other for-profit institutions. *Estimated Number of Respondents:* 9,000. *Estimated Number of Annual Responses:* 206,100. *Estimated Time per Response:* 5 minutes. *Estimated Total Annual Burden Hours:* 17,326. Dated: June 25, 2008. Tracey Denning, Agency Clearance Officer, Customs and Border Protection. [FR Doc. E8-14560 Filed 6-26-08; 8:45 am] BILLING CODE 9111-14-P DEPARTMENT OF HOMELAND SECURITY U.S. Customs and Border Protection Proposed Collection; Comment Request; Vessel Entrance or Clearance Statement AGENCY: U.S. Customs and Border Protection (CBP), Department of Homeland Security. ACTION: 60-Day Notice and request for comments; Extension of existing collection of information: 1651-0019 SUMMARY: The Department of Homeland Security, as part of its continuing effort to reduce paperwork and respondent burden, CBP invites the general public and other Federal agencies to comment on an information collection requirement concerning Vessel Entrance of Clearance Statement. This request for comment is being made pursuant to the Paperwork Reduction Act of 1995 (Pub. L. 104-13; 44 U.S.C. 3505(c)(2)). DATES: Written comments should be received on or before August 26, 2008, to be assured of consideration. ADDRESSES: Direct all written comments to U.S. Customs and Border Protection, Attn.: Tracey Denning, 1300 Pennsylvania Avenue, NW., Room 3.2C, Washington, DC 20229. FOR FURTHER INFORMATION CONTACT: Requests for additional information should be directed to U.S. Customs and Border Protection, Attn.: Tracey Denning, 1300 Pennsylvania Avenue, NW., Room 3.2C, Washington, DC 20229, Tel.

(a)Whether the collection of information is necessary for the proper performance of the functions of the agency, including whether the information shall have practical utility;

(b)the accuracy of the agency's estimates of the burden of the collection of information;

(c)ways to enhance the quality, utility, and clarity of the information to be collected;

(d)ways to minimize the burden including the use of automated collection techniques or the use of other forms of information technology; and

(e)estimates of capital or start-up costs and costs of operations, maintenance, and purchase of services to provide information. The comments that are submitted will be summarized and included in the CBP request for Office of Management and Budget

(OMB)approval. All comments will become a matter of public record. In this document CBP is soliciting comments concerning the following information collection: *Title:* Vessel Entrance or Clearance Statement Form. *OMB Number:* 1651-0019. *Form Number:* CBP Form 1300. *Abstract:* This form is used by a master of a vessel to attest to the truthfulness of all other forms associated with the manifest. *Current Actions:* There are no changes to the information collection. This submission is being submitted to extend the expiration date. *Type of Review:* Extension (without change). *Affected Public:* Businesses, Individuals, Institutions. *Estimated Number of Respondents:* 12,000. *Estimated Number of Annual Responses:* 264,000. *Estimated Time per Response:* 5 minutes. *Estimated Total Annual Burden Hours:* 21,991. Dated: June 23, 2008. Tracey Denning, Agency Clearance Officer, Customs and Border Protection. [FR Doc. E8-14561 Filed 6-26-08; 8:45 am] BILLING CODE 9111-14-P DEPARTMENT OF HOMELAND SECURITY U.S. Customs and Border Protection Agency Information Collection Activities: Certificate of Origin AGENCY: U.S. Customs and Border Protection, Department of Homeland Security. ACTION: 30-Day Notice and request for comments; Extension of an existing information collection: 1651-0016; Proposed collection; comments requested. SUMMARY: U.S. Customs and Border Protection

(CBP)of the Department of Homeland Security has submitted the following information collection request to the Office of Management and Budget

(OMB)for review and approval in accordance with the Paperwork Reduction Act: Certificate of Origin. This is a proposed extension of an information collection that was previously approved. CBP is proposing that this information collection be extended with no change to the burden hours. This document is published to obtain comments form the public and affected agencies. This proposed information collection was previously published in the **Federal Register** (73 FR 15766-15767) on March 25, 2008, allowing for a 60-day comment period. One public comment was received. CBP will respond to this comment. This notice allows for an additional 30 days for public comments. This process is conducted in accordance with 5 CFR 1320.10. DATES: Written comments should be received on or before July 28, 2008. ADDRESSES: Interested persons are invited to submit written comments on the proposed information collection to the Office of Information and Regulatory Affairs, Office of Management and Budget. Comments should be addressed to the OMB Desk Officer for Customs and Border Protection, Department of Homeland Security, and sent via electronic mail to *oira_submission@omb.eop.gov* or faxed to

(202)395-6974. SUPPLEMENTARY INFORMATION: U.S. Customs and Border Protection

(CBP)encourages the general public and affected Federal agencies to submit written comments and suggestions on proposed and/or continuing information collection requests pursuant to the Paperwork Reduction Act (Pub. L. 104-13). Your comments should address one of the following four points:

(1)Evaluate whether the proposed collection of information is necessary for the proper performance of the functions of the agency/component, including whether the information will have practical utility;

(2)Evaluate the accuracy of the agencies/components estimate of the burden of The proposed collection of information, including the validity of the methodology and assumptions used;

(3)Enhance the quality, utility, and clarity of the information to be collected; and

(4)Minimize the burden of the collections of information on those who are to respond, including the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology, e.g., permitting electronic submission of responses. *Title:* Certificate of Origin. *OMB Number:* 1651-0016. *Form Number:* CBP Form 3229. *Abstract:* This certification is required to determine whether an importer is entitled to duty-free for goods which are the growth or product of a U.S. insular possession and which contain foreign materials representing no more than 70 percent of the goods total value. *Current Actions:* There are no changes to the information collection. This submission is being submitted to extend the expiration date. *Type of Review:* Extension (without change). *Affected Public:* Business or other for-profit institutions. *Estimated Number of Respondents:* 10. *Estimated Number of Annual Responses:* 310. *Estimated Time per Response:* 22 minutes. *Estimated Total Annual Burden Hours:* 113. If additional information is required contact: Tracey Denning, U.S. Customs and Border Protection, 1300 Pennsylvania Avenue, NW., Room 3.2.C, Washington, DC 20229, at 202-344-1429. Dated: June 18, 2008. Tracey Denning, Agency Clearance Officer, Customs and Border Protection. [FR Doc. E8-14562 Filed 6-26-08; 8:45 am] BILLING CODE 9111-14-P DEPARTMENT OF HOMELAND SECURITY U.S. Customs and Border Protection Proposed Collection; Comment Request; Entry and Manifest of Merchandise Free of Duty AGENCY: U.S. Customs and Border Protection (CBP), Department of Homeland Security. ACTION: 60-Day Notice and request for comments; Extension of existing collection of information: 1651-0013. SUMMARY: As part of its continuing effort to reduce paperwork and respondent burden, CBP invites the general public and other Federal agencies to comment on an information collection requirement concerning the Entry and Manifest of Merchandise Free of Duty. This request for comment is being made pursuant to the Paperwork Reduction Act of 1995 (Pub. L. 104-13; 44 U.S.C. 3505(c)(2)). DATES: Written comments should be received on or before August 26, 2008, to be assured of consideration. ADDRESSES: Direct all written comments to U.S. Customs and Border Protection, Attn.: Tracey Denning, 1300 Pennsylvania Avenue, NW., Room 3.2C, Washington, DC 20229. FOR FURTHER INFORMATION CONTACT: Requests for additional information should be directed to U.S. Customs and Border Protection, Attn.: Tracey Denning, 1300 Pennsylvania Avenue, NW., Room 3.2C, Washington, DC 20229, Tel.

(a)Whether the collection of information is necessary for the proper performance of the functions of the agency, including whether the information shall have practical utility;

(b)the accuracy of the agency's estimates of the burden of the collection of information;

(c)ways to enhance the quality, utility, and clarity of the information to be collected;

(d)ways to minimize the burden including the use of automated collection techniques or the use of other forms of information technology; and

(OMB)approval. All comments will become a matter of public record. In this document CBP is soliciting comments concerning the following information collection: *Title:* Entry and Manifest of Merchandise Free of Duty. *OMB Number:* 1651-0013. *Form Number:* CBP Form-7523. *Abstract:* CBP Form-7523 is used by carriers and importers as a manifest for the entry of merchandise free of duty under certain conditions, and by CBP to authorize the entry of such merchandise. It is also used by carriers to show that the articles being imported have been released to the importer or consignee. *Current Actions:* There are no changes to the information collection. This submission is being submitted to extend the expiration date. *Type of Review:* Extension (without change). *Affected Public:* Business or other for-profit institutions. *Estimated Number of Respondents:* 4,950. *Estimated Number of Annual Responses:* 99,000. *Estimated Time per Response:* 5 minutes. *Estimated Total Annual Burden Hours:* 8,247. Dated: June 23, 2008. Tracey Denning, Agency Clearance Officer, Customs and Border Protection. [FR Doc. E8-14564 Filed 6-26-08; 8:45 am] BILLING CODE 9111-14-P DEPARTMENT OF HOMELAND SECURITY U.S. Customs and Border Protection Proposed Collection; Comment Request; Entry Summary and Continuation Sheet AGENCY: U.S. Customs and Border Protection (CBP), Department of Homeland Security. ACTION: 60-day notice and request for comments; extension of existing collection of information: 1651-0022. SUMMARY: The Department of Homeland Security, as part of its continuing effort to reduce paperwork and respondent burden, CBP invites the general public and other Federal agencies to comment on an information collection requirement concerning the Entry Summary and Continuation Sheet. This request for comment is being made pursuant to the Paperwork Reduction Act of 1995 (Pub. L. 104-13; 44 U.S.C. 3506(c)(2)(A)). DATES: Written comments should be received on or before August 26, 2008, to be assured of consideration. ADDRESSES: Direct all written comments to Bureau of Customs and Border Protection, Attn.: Tracey Denning, 1300 Pennsylvania Avenue, NW., Room 3.2C, Washington, DC 20229. FOR FURTHER INFORMATION CONTACT: Requests for additional information should be directed to Bureau of Customs and Border Protection, Attn.: Tracey Denning, 1300 Pennsylvania Avenue, NW., Room 3.2C, Washington, DC 20229, Tel.

(a)Whether the collection of information is necessary for the proper performance of the functions of the agency, including whether the information shall have practical utility;

(b)the accuracy of the agency's estimates of the burden of the collection of information; ways to enhance the quality, utility, and clarity of the information to be collected;

(c)ways to minimize the burden including the use of automated collection techniques or the use of other forms of information technology; and

(d)estimates of capital or start-up costs and costs of operations, maintenance, and purchase of services to provide information. The comments that are submitted will be summarized and included in the CBP request for Office of Management and Budget

(CBP)of the Department of Homeland Security has submitted the following information collection request to the Office of Management and Budget

(OMB)for review and approval in accordance with the Paperwork Reduction Act: Drawback Process Regulations. This is a proposed extension with a change to the burden hours of an information collection that was previously approved. CBP is proposing that this information collection be extended with no change to the burden hours. This document is published to obtain comments form the public and affected agencies. This proposed information collection was previously published in the **Federal Register** (73 FR 15764) on March 25, 2008, allowing for a 60-day comment period. Three public comments were received. CBP will respond to these comments. This notice allows for an additional 30 days for public comments. DATES: Written comments should be received on or before July 28, 2008. ADDRESSES: Interested persons are invited to submit written comments on the proposed information collection to the Office of Information and Regulatory Affairs, Office of Management and Budget. Comments should be addressed to the OMB Desk Officer for Customs and Border Protection, Department of Homeland Security, and sent via electronic mail to: *oira_submission@omb.eop.gov* or faxed to

(202)395-6974. SUPPLEMENTARY INFORMATION: U.S. Customs and Border Protection

(2)Evaluate the accuracy of the agencies/components estimate of the burden of The proposed collection of information, including the validity of the methodology and assumptions used;

(3)Enhance the quality, utility, and clarity of the information to be collected; and

(4)Minimize the burden of the collections of information on those who are to respond, including the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology, e.g., permitting electronic submission of responses. *Title:* Drawback Process Regulations. *OMB Number:* 1651-0075. *Form Number:* Forms CBP-7551, 7552, 7553. *Abstract:* The information is to be used by CBP officers to expedite the filing and processing of drawback claims, while maintaining necessary enforcement information to maintain effective administrative oversight over the drawback program. *Current Actions:* This submission is being submitted to extend the expiration date with a change to the burden hours. *Type of Review:* Extension (with change). *Affected Public:* Businesses, Institutions. *Estimated Number of Respondents:* 8,150. *Estimated Number of Annual Responses:* 163,000. *Estimated Time Per Response:* 34 minutes. *Estimated Total Annual Burden Hours:* 93,250. If additional information is required contact: Tracey Denning, U.S. Customs and Border Protection, 1300 Pennsylvania Avenue, NW., Room 3.2.C, Washington, DC 20229, at 202-344-1429. Dated: June 23, 2008. Tracey Denning, Agency Clearance Officer, Customs and Border Protection. [FR Doc. E8-14570 Filed 6-26-08; 8:45 am] BILLING CODE 9111-14-P DEPARTMENT OF HOMELAND SECURITY U.S. Customs and Border Protection Proposed Collection; Comment Request; Petition for Remission or Mitigation of Forfeitures and Penalties AGENCY: U.S. Customs and Border Protection (CBP), Department of Homeland Security. ACTION: 60-Day Notice and request for comments; Extension of existing collection of information: 1651-0100. SUMMARY: As part of its continuing effort to reduce paperwork and respondent burden, CBP invites the general public and other Federal agencies to comment on an information collection requirement concerning the Petition for Remission or Mitigation of Forfeitures and Penalties. This request for comment is being made pursuant to the Paperwork Reduction Act of 1995 (Pub. L. 104-13; 44 U.S.C. 3506(c)(2)(A)). DATES: Written comments should be received on or before August 26, 2008, to be assured of consideration. ADDRESSES: Direct all written comments to the U.S. Customs and Border Protection, Information Services Group, Attn.: Tracey Denning, 1300 Pennsylvania Avenue, NW., Room 3.2.C, Washington, DC 20229. FOR FURTHER INFORMATION CONTACT: Requests for additional information should be directed to the U.S. Customs and Border Protection, Attn.: Tracey Denning, 1300 Pennsylvania Avenue, NW., Room 3.2.C, Washington, DC 20229, Tel.

(a)Whether the collection of information is necessary for the proper performance of the functions of the agency, including whether the information shall have practical utility;

(b)the accuracy of the agency's estimates of the burden of the collection of information;

(c)ways to enhance the quality, utility, and clarity of the information to be collected;

(d)ways to minimize the burden including the use of automated collection techniques or the use of other forms of information technology; and

(OMB)approval. All comments will become a matter of public record. In this document Customs is soliciting comments concerning the following information collection: *Title:* Petition for Remission or Mitigation of Forfeitures and Penalties. *OMB Number:* 1651-0100. *Form Number:* CBP Form 4609. *Abstract:* Persons whose property is seized or who incur monetary penalties due to violations of the Tariff Act are entitled to seek remission or mitigation by means of an informal appeal. This form gives the violator the opportunity to claim mitigation and provides a record of such administrative appeals. *Current Actions:* There are no changes to the information collection. This submission is being submitted to extend the expiration date. *Type of Review:* Extension (without change). *Affected Public:* Business or other for-profit institutions. *Estimated Number of Respondents:* 28,000. *Estimated Number of Annual Responses:* 28,000. *Estimated Time Per Respondent:* 14 minutes. *Estimated Total Annual Burden Hours:* 6,500. Dated: June 23, 2008. Tracey Denning, Agency Clearance Officer, Customs and Border Protection. [FR Doc. E8-14571 Filed 6-26-08; 8:45 am] BILLING CODE 9111-14-P DEPARTMENT OF HOUSING AND URBAN DEVELOPMENT [Docket No. FR-5186-N-26] Federal Property Suitable as Facilities To Assist the Homeless AGENCY: Office of the Assistant Secretary for Community Planning and Development, HUD. ACTION: Notice. SUMMARY: This Notice identifies unutilized, underutilized, excess, and surplus Federal property reviewed by HUD for suitability for possible use to assist the homeless. FOR FURTHER INFORMATION CONTACT: Kathy Ezzell, Department of Housing and Urban Development, 451 Seventh Street, SW., Room 7266, Washington, DC 20410; telephone

(202)708-1234; TTY number for the hearing- and speech-impaired

(202)708-2565 (these telephone numbers are not toll-free), or call the toll-free Title V information line at 800-927-7588. SUPPLEMENTARY INFORMATION: In accordance with 24 CFR part 581 and section 501 of the Stewart B. McKinney Homeless Assistance Act (42 U.S.C. 11411), as amended, HUD is publishing this Notice to identify Federal buildings and other real property that HUD has reviewed for suitability for use to assist the homeless. The properties were reviewed using information provided to HUD by Federal landholding agencies regarding unutilized and underutilized buildings and real property controlled by such agencies or by GSA regarding its inventory of excess or surplus Federal property. This Notice is also published in order to comply with the December 12, 1988 Court Order in *National Coalition for the Homeless* v. *Veterans Administration* , No. 88-2503-OG (D.D.C.). Properties reviewed are listed in this Notice according to the following categories: Suitable/available, suitable/unavailable, suitable/to be excess, and unsuitable. The properties listed in the three suitable categories have been reviewed by the landholding agencies, and each agency has transmitted to HUD:

(1)Its intention to make the property available for use to assist the homeless,

(2)its intention to declare the property excess to the agency's needs, or

(3)a statement of the reasons that the property cannot be declared excess or made available for use as facilities to assist the homeless. Properties listed as suitable/available will be available exclusively for homeless use for a period of 60 days from the date of this Notice. Where property is described as for “off-site use only” recipients of the property will be required to relocate the building to their own site at their own expense. Homeless assistance providers interested in any such property should send a written expression of interest to HHS, addressed to Theresa Rita, Division of Property Management, Program Support Center, HHS, room 5B-17, 5600 Fishers Lane, Rockville, MD 20857;

(301)443-2265. (This is not a toll-free number.) HHS will mail to the interested provider an application packet, which will include instructions for completing the application. In order to maximize the opportunity to utilize a suitable property, providers should submit their written expressions of interest as soon as possible. For complete details concerning the processing of applications, the reader is encouraged to refer to the interim rule governing this program, 24 CFR part 581. For properties listed as suitable/to be excess, that property may, if subsequently accepted as excess by GSA, be made available for use by the homeless in accordance with applicable law, subject to screening for other Federal use. At the appropriate time, HUD will publish the property in a Notice showing it as either suitable/available or suitable/unavailable. For properties listed as suitable/unavailable, the landholding agency has decided that the property cannot be declared excess or made available for use to assist the homeless, and the property will not be available. Properties listed as unsuitable will not be made available for any other purpose for 20 days from the date of this Notice. Homeless assistance providers interested in a review by HUD of the determination of unsuitability should call the toll free information line at 1-800-927-7588 for detailed instructions or write a letter to Mark Johnston at the address listed at the beginning of this Notice. Included in the request for review should be the property address (including zip code), the date of publication in the **Federal Register** , the landholding agency, and the property number. For more information regarding particular properties identified in this Notice ( *i.e.* , acreage, floor plan, existing sanitary facilities, exact street address), providers should contact the appropriate landholding agencies at the following addresses: COAST GUARD: Commandant, United States Coast Guard, Attn: Teresa Sheinberg, 2100 Second St., SW., Rm 6109, Washington, DC 20593-0001;

(202)267-6142; ENERGY: Mr. Mark Price, Department of Energy, Office of Engineering & Construction Management, MA-50, 1000 Independence Ave., SW., Washington, DC 20585:

(202)586-5422; GSA: Mr. John Smith, Deputy Assistant Commissioner, General Services Administration, Office of Property Disposal, 18th & F Streets, NW., Washington, DC 20405;

(202)501-0084; NAVY: Mrs. Mary Arndt, Acting Director, Department of the Navy, Real Estate Services, Naval Facilities Engineering Command, Washington Navy Yard, 1322 Patterson Ave., SE., Suite 1000, Washington, DC 20374-5065;

(202)685-9305; (These are not toll-free numbers.) Dated: June 19, 2008. Mark R. Johnston, Deputy Assistant Secretary for Special Needs. Title V, Federal Surplus Property Program Federal Register Report for 06/27/2008 Suitable/Available Properties Building Arizona Water Conservation Lab 4331 E. Broadway Rd. Phoenix AZ 85040 Landholding Agency: GSA Property Number: 54200820013 Status: Excess GSA Number: 9-A-AZ-846-1 Comments: 11365 sq. ft. main bldg w/11 additional bldgs. & 66 paved parking spaces, easement restrictions, zoning issue North Dakota Facility F-O Foxtrot Grand Forks ND Landholding Agency: GSA Property Number: 54200820015 Status: Surplus GSA Number: 7-D-ND-0500 Comments: 5850 sq. ft. facility, asbestos/PCB's/lead based paint, restrictions and covenants Suitable/Available Properties Building Oklahoma Maintenance Site Rt. 1 Tupelo OK 74572 Landholding Agency: GSA Property Number: 54200820016 Status: Excess GSA Number: 7-GR-OK-0574 Comments: Office/garage/storage, easement restrictions Land Texas FAA Outer Marker 18 R/L VYN 1420 Lakeside Pkwy Flower Mound TX 75028 Landholding Agency: GSA Property Number: 54200820017 Status: Surplus GSA Number: 7-U-TX-1090 Comments: 1.428 acres, radar facility FAA Outer Marker 31R RAA 1600 Cooper Drive Irving TX 75061 Landholding Agency: GSA Property Number: 54200820018 Status: Surplus GSA Number: 7-U-TX-1095 Comments: 0.305 acre, radar facility Suitable/Available Properties Land Texas FAA Outer Marker 35R AJQ 300 W. Shady Grove Grand Prairie TX 75050 Landholding Agency: GSA Property Number: 54200820019 Status: Surplus GSA Number: 7-U-TX-1094 Comments: 0.674 acre, radar facility Unsuitable Properties Building California Bldg. 19 USCG Integrated Sup Comm San Pedro CA 90731 Landholding Agency: Coast Guard Property Number: 88200820004 Status: Unutilized Reasons: Extensive deterioration Unsuitable Properties Building Hawaii Bldg. 1981 Naval Station Pearl Harbor HI 96860 Landholding Agency: Navy Property Number: 77200820038 Status: Unutilized Reasons: Extensive deterioration Bldg. 17 Naval Station Pearl Harbor HI 96860 Landholding Agency: Navy Property Number: 77200820039 Status: Excess Reasons: Extensive deterioration Bldg. 88 Naval Station Ford Island Pearl Harbor HI 96860 Landholding Agency: Navy Property Number: 77200820040 Status: Excess Reasons: Extensive deterioration Unsuitable Properties Building Idaho RCLR Facility State Hwy 69 Meridian ID 83704 Landholding Agency: GSA Property Number: 54200820014 Status: Excess GSA Number: 9-U-ID-566 Reasons: Within 2000 ft. of flammable or explosive material Illinois Bldg. 40 Argonne National Lab DuPage IL 60439 Landholding Agency: Energy Property Number: 41200820007 Status: Excess Reasons: Contamination; Secured Area Rhode Island Bldgs. 348, 85CHI Naval Station Newport RI Landholding Agency: Navy Property Number: 77200820043 Status: Unutilized Reasons: Secured Area Unsuitable Properties Building Rhode Island Facility 670 Naval Station Harbor Island Newport RI 02841 Landholding Agency: Navy Property Number: 77200820044 Status: Excess Reasons: Extensive deterioration; Secured Area Land North Carolina 0.23 acres/French Creek Marine Corps Base Camp Lejeune NC Landholding Agency: Navy Property Number: 77200820041 Status: Underutilized Reasons: Secured Area 0.23 acres/Onslow Beach Marine Corps Base Camp Lejeune NC Landholding Agency: Navy Property Number: 77200820042 Status: Underutilized Reasons: Secured Area Unsuitable Properties Land Virginia FAA Outer Marker 19R Norman's Station Rd. Chantilly VA 20151 Landholding Agency: GSA Property Number: 54200820020 Status: Surplus GSA Number: 11-VA-1103AA Reasons: Within airport runway clear zone; Within 2000 ft. of flammable or explosive material [FR Doc. E8-14290 Filed 6-26-08; 8:45 am] BILLING CODE 4210-67-P DEPARTMENT OF HOUSING AND URBAN DEVELOPMENT Office of Federal Housing Enterprise Oversight; Privacy Act of 1974, as Amended; Amendment of Systems of Records AGENCY: Office of Federal Housing Enterprise Oversight, HUD. ACTION: Notice of amendment to systems of records. SUMMARY: In accordance with the Privacy Act of 1974, as amended, 5 U.S.C. 552a (Privacy Act), the Office of Federal Housing Enterprise Oversight (OFHEO) is issuing public notice of its intent to revise one existing system of records and delete one existing system of records. The systems are being revised or deleted as a result of reevaluation of the manner in which OFHEO maintains the records. OFHEO is combining these two systems of records into one expanded system, therefore, OFHEO-05, Senior Staff Biography System will be deleted, and the number OFHEO-05 reserved for future use. The revised system, OFHEO-03, Employee Identification Card System will be renamed the Staff Information and Identification System and will include information formerly maintained in OFHEO-05, Senior Staff Biography System. Revisions will incorporate administrative changes that have taken place since the last publication of OFHEO-03 at 63 FR 9007 on February 23, 1998. The revised system of records will consist of information on employees and contractors in order to issue temporary identification cards; provide biographical information to the media and other groups which request information on OFHEO staff as speakers or panel participants; and provide a resource to allow management to identify employees and contractors by their photograph, status and organizational office. DATES: Written comments must be received by or before July 28, 2008. If no public comments are received, the proposed new system of records will become effective on August 6, 2008. ADDRESSES: You may submit comments, identified by “Staff Information and Identification System,” by any of the following methods: • *Federal e-Rulemaking Portal: http://www.regulations.gov* . Follow the instructions for submitting comments. • *Agency Web Site: http://www.ofheo.gov.* Follow the instructions for submitting comments on the OFHEO Web site. • *E-mail: RegComments@OFHEO.gov.* Please include “Staff Information and Identification System” in the subject line of the message. • *Mail:* The mailing address for comments is: Alfred M. Pollard, General Counsel, Attention: Comments “Staff Information and Identification System,” Office of Federal Housing Enterprise Oversight, 1700 G Street, NW., Washington, DC 20552. • *Hand Delivery/Courier:* The address for hand delivery/courier is: Alfred M. Pollard, General Counsel, Attention: Comments “Staff Information and Identification System,” Office of Federal Housing Enterprise Oversight, 1700 G Street, NW., Washington, DC 20552. The package should be logged at the Guard Desk, First Floor, on business days between 9 a.m. and 3 p.m. See SUPPLEMENTARY INFORMATION for additional information on submission and posting of comments. FOR FURTHER INFORMATION CONTACT: Mark D. Laponsky, Deputy General Counsel, telephone

(202)414-3832 (not a toll-free number); Office of Federal Housing Enterprise Oversight, 1700 G Street, NW., Washington, DC 20552. The telephone number for the Telecommunications Device for the Deaf is

(800)877-8339 (TDD *Only* ). SUPPLEMENTARY INFORMATION: *Instructions:* OFHEO invites comments on the proposed revision to an existing system of records described in this notice. Comments should include the agency name and the reference “Staff Information and Identification System” as well as your name and other contact information in the body of your comment. OFHEO further requests that comments submitted in hard copy also be accompanied by the electronic version in Microsoft® Word or in portable document format

(PDF)on 3.5″ disk or CD-ROM. *Posting and Public Availability of Comments:* All comments received will be posted without change to *http://www.regulations.gov* as well as on the OFHEO Internet Web site at *http://www.ofheo.gov* and will include any personal information provided. In addition, copies of all comments received will be available for examination by the public on business days between the hours of 10 a.m. and 3 p.m., at the Office of Federal Housing Enterprise Oversight, 1700 G Street, NW., Washington, DC. To make an appointment to inspect comments, please call the Office of General Counsel at

(202)414-6924. *Introduction:* This notice informs the public that OFHEO proposes to revise an existing system of records and delete an obsolete system of records. This notice satisfies the Privacy Act requirement that agencies publish notices in the **Federal Register** describing new or altered systems of records. The revised system of records is: *OFHEO-03, Staff Information and Identification System* (formerly known as the Employee Identification Card System) The deleted system of records is: *OFHEO-05, Senior Staff Biography System* As required by 5 U.S.C. 552a(r) of the Privacy Act, and pursuant to paragraph 4c of Appendix I to OMB Circular No. A-130, OFHEO is filing a report describing the amended systems of records covered by this notice to the Chair of the House Committee on Oversight and Government Reform, the Chair of the Senate Committee on Homeland Security and Governmental Affairs, and the Office of Management and Budget. The proposed alterations to an existing system of records, as described above, are set forth in its entirety below. Dated: June 23, 2008. James B. Lockhart III, Director. OFHEO-03 SYSTEM NAME: Staff Information and Identification System. SYSTEM LOCATION: The Office of Management Planning, OFHEO, 1700 G Street, NW., Washington, DC 20552, and any alternate work site utilized by employees of the Office of Federal Housing Enterprise Oversight (OFHEO) or individuals assisting such employees. CATEGORIES OF INDIVIDUALS COVERED BY THE SYSTEM: OFHEO employees and contractor personnel. CATEGORIES OF RECORDS IN THE SYSTEM: Records may include the individual's name, photograph, temporary identification card issue and expiration date, status, organizational office, educational background, experience, professional accomplishment, and affiliations. AUTHORITY FOR MAINTENANCE OF THE SYSTEM: The Safety and Soundness Act (12 U.S.C. 4513(b)(9)). PURPOSE(S): Information in this system will be used by OFHEO to establish and maintain a repository of information on employees and contractors in order to issue temporary identification cards; to provide biographical information to the media and other groups which request information on OFHEO staff as speakers or panel participants; and to provide a resource to allow management to identify employees and contractors by their photograph, status and organizational office. ROUTINE USES OF RECORDS MAINTAINED IN THE SYSTEM, INCLUDING CATEGORIES OF USERS AND THE PURPOSES OF SUCH USES: In addition to the conditions of disclosure under 5 U.S.C.552a(b) and in addition to the general routine uses identified in the Prefatory Statement of General Routine Uses, 63 FR 9007 (February 23, 1998), it shall be a routine use to disclose information contained in this system for the purposes and to the users identified below: 1. To appropriate persons, consultants, contractors, entities or others in the event of a breach of data contained in the system, as necessary for the purposes of responding to and remedying a breach. 2. To first responders and others as necessary to provide emergency response or evacuation assistance to covered individuals. 3. To appropriate individuals in the news media, public affairs personnel, and groups which request OFHEO staff as speakers or panel participants. 4. To appropriate persons, consultants, and contractors to allow positive identification of employees. DISCLOSURE TO CONSUMER REPORTING AGENCIES: Disclosures may be made from this system pursuant to 5 U.S.C. 552a(b)(12) to consumer reporting agencies as defined in the Fair Credit Reporting Act (15 U.S.C. 1681a(f)) when OFHEO is trying to collect a claim of the Government under a law, except the Internal Revenue Code of 1986, in accordance with 31 U.S.C. 3711(e). POLICIES AND PRACTICES FOR STORING, RETRIEVING, ACCESSING, RETAINING, AND DISPOSING OF RECORDS IN THE SYSTEM: STORAGE: Records will be stored in both electronic and paper format. Paper records are to be maintained in file folders or binders. Computer files are to be maintained on magnetic tape, CD, or other machine readable format. RETRIEVABILITY: Records will be retrieved by the individual's name, identification card issue date, status, or organizational office. SAFEGUARDS: Access is restricted to OFHEO employees and contractors who require the information in performing their official duties. Access to computerized records is limited, through use of access codes and entry logs to those whose official duties require access. Paper records are maintained in locked cabinets. RETENTION AND DISPOSAL: Records will be maintained and disposed of in accordance with the National Archives and Records Administration General Records Schedule 18, Item 19. SYSTEM MANAGER(S) AND ADDRESS: Chief Human Capital Officer, Office of Human Resources Management, OFHEO, 1700 G Street, NW., Washington, DC 20552. Associate Director, Office of Management Planning, OFHEO, 1700 G Street, NW., Washington, DC 20552. NOTIFICATION PROCEDURE: An individual can determine if this system contains a record pertaining to him/her by sending a request in writing, signed, to Contact the Privacy Act Officer, Office of Federal Housing Enterprise Oversight, 1700 G Street, NW., Washington, DC 20552. When requesting notification of or access to records covered by this Notice, an individual should provide his/her full name, date of birth, agency name, and work location. An individual requesting notification of records in person must provide identity documents sufficient to satisfy the custodian of the records that the requester is entitled to access, such as a government-issued photo ID. Individuals requesting notification via mail or telephone must furnish, at minimum, name, date of birth, social security number, and home address in order to establish identity. RECORD ACCESS PROCEDURES: The OFHEO regulation for providing access to records appears at 12 CFR part 1702. If additional information or assistance is required, contact the Privacy Act Officer, Office of Federal Housing Enterprise Oversight, 1700 G Street, NW., Washington, DC 20552. CONTESTING RECORD PROCEDURES: The procedures for contesting initial denials for access to or amendment of records appears at 12 CFR part 1702. If additional information or assistance is required, contact the Privacy Act Officer at OFHEO, 1700 G Street, NW., Washington, DC 20552. RECORD SOURCE CATEGORIES: The information is obtained from the individuals on whom the information is maintained, from the OFHEO Office of Human Resources Management staff, the Office of Management Planning staff, and from the Office of Budget & Financial Management. EXEMPTIONS CLAIMED FOR THE SYSTEM: None. [FR Doc. E8-14693 Filed 6-26-08; 8:45 am] BILLING CODE 4220-01-P DEPARTMENT OF THE INTERIOR Fish and Wildlife Service [FWS-R9-NCTC-2008-N0157] [97310-1661-0030] Information Collection Sent to the Office of Management and Budget

(OMB)for Approval; OMB Control Number 1018-0115, Application for Training, National Conservation Training Center AGENCY: Fish and Wildlife Service, Interior. ACTION: Notice; request for comments. SUMMARY: We (Fish and Wildlife Service) have sent an Information Collection Request

(ICR)to OMB for review and approval. The ICR, which is summarized below, describes the nature of the collection and the estimated burden and cost. This IC is scheduled to expire on June 30, 2008. We may not conduct or sponsor and a person is not required to respond to a collection of information unless it displays a currently valid OMB control number. However, under OMB regulations, we may continue to conduct or sponsor this information collection while it is pending at OMB. DATES: You must submit comments on or before July 28, 2008. ADDRESSES: Send your comments and suggestions on this ICR to the Desk Officer for the Department of the Interior at OMB-OIRA at

(202)395-6566

(fax)or OIRA_DOCKET@OMB.eop.gov (e-mail). Please provide a copy of your comments to Hope Grey, Information Collection Clearance Officer, Fish and Wildlife Service, MS 222-ARLSQ, 4401 North Fairfax Drive, Arlington, VA 22203 (mail);

(703)358-2269 (fax); or hope_grey@fws.gov (e-mail). FOR FURTHER INFORMATION CONTACT: To request additional information about this ICR, contact Hope Grey by mail, fax, or e-mail (see ADDRESSES) or by telephone at

(703)358-2482. SUPPLEMENTARY INFORMATION: *OMB Control Number:* 1018-0115. *Title:* Application for Training, National Conservation Training Center. *Service Form Number(s):* 3-2193. *Type of Request:* Extension of a currently approved collection. *Affected Public:* Persons who wish to participate in training given at or sponsored by the National Conservation Training Center (NCTC). *Respondent's Obligation:* Voluntary. *Frequency of Collection:* On occasion when applying for training at NCTC. *Estimated Annual Number of Respondents:* 500. *Estimated Total Annual Responses:* 500. *Estimated Time Per Response:* 10 minutes. *Estimated Total Annual Burden Hours:* 83. *Abstract:* The Fish and Wildlife Service National Conservation Training Center in Shepherdstown, West Virginia, provides natural resource and other professional training for Service employees, employees of other Federal agencies, and other affiliations, including State agencies, private individuals, not-for-profit organizations, and university personnel. FWS Form 3-2193 (Training Application) is a quick and easy method for prospective non-Department of the Interior students to request training. We encourage applicants to use FWS Form 3-2193 and to submit their requests electronically. However, we do not require applicants to complete both a training form required by their agency and FWS Form 3-2193. NCTC will accept any single training request as long as each submission identifies the name, address, and phone number of the applicant, sponsoring agency, class name, start date, and all required financial payment information. NCTC uses data from the form to generate class rosters, class transcripts, and statistics, and as a budgeting tool for projecting training requirements. It is also used to track attendance, mandatory requirements, tuition, and invoicing for all NCTC-sponsored courses both on- and off-site. *Comments:* On April 25, 2008, we published in the Federal Register (73 FR 22430) a notice of our intent to request that OMB renew approval for this information collection. In that notice, we solicited comments for 60 days, ending on June 24, 2008. We received one comment. The comment was directed to the subject matter, validity, and necessity of the training and not at the need for the information collection. The commenter stated that training does not help the general public and that NCTC is a private hunting club. The commenter believes that the training we provide is focused on gun, hunting, and violence proponents. All training courses that NCTC offers, with the exception of some bureau specific courses, are open to members of the general public who have the required background experience or knowledge to allow their full understanding of the subject matter. Very few of our training courses have an emphasis on guns and hunting. Those courses that do touch on this subject are presented in the context of refuge and wildlife management and law enforcement. We have not made any changes to the collection in response to this comment. We again invite comments concerning this information collection on:

(1)whether or not the collection of information is necessary, including whether or not the information will have practical utility;

(2)the accuracy of our estimate of the burden for this collection of information;

(3)ways to enhance the quality, utility, and clarity of the information to be collected; and

(OMB)for Approval; OMB Control Number 1018-0103; Conservation Order for Control of Midcontinent Light Geese AGENCY: Fish and Wildlife Service, Interior. ACTION: Notice; request for comments. SUMMARY: We (Fish and Wildlife Service) have sent an Information Collection Request

(ICR)to OMB for review and approval. The ICR, which is summarized below, describes the nature of the collection and the estimated burden and cost. This ICR is scheduled to expire on June 30, 2008. We may not conduct or sponsor and a person is not required to respond to a collection of information unless it displays a currently valid OMB control number. However, under OMB regulations, we may continue to conduct or sponsor this information collection while it is pending at OMB. DATES: You must submit comments on or before July 28, 2008. ADDRESSES: Send your comments and suggestions on this ICR to the Desk Officer for the Department of the Interior at OMB-OIRA at

(202)395-6566

(703)358-2482. SUPPLEMENTARY INFORMATION: *OMB Control Number:* 1018-0103. *Title:* Conservation Order for Control of Midcontinent Light Geese, 50 CFR 21.60. *Service Form Number(s):* None. *Type of Request:* Extension of currently approved collection. *Affected Public:* State and tribal governments. *Respondent's Obligation:* Required to obtain or retain a benefit. *Frequency of Collection:* Annually. *Number of Respondents:* 24. *Number of Annual Responses:* 24. *Completion Time per Response:* 74 hours. *Total Annual Burden Hours:* 1,776 hours. *Abstract:* The number of light geese (lesser snow, greater snow, and Ross' geese) in the midcontinent region has nearly quadrupled during the past several decades due to a decline in adult mortality and an increase in winter survival. We refer to these species and subspecies as light geese because of their light coloration as opposed to dark geese such as white-fronted or Canada geese. Because of their feeding activity, light geese have become seriously injurious to their habitat as well as to habitat important to other migratory birds. This poses a serious threat to the short- and long-term health and status of some migratory bird populations. We believe that the number of light geese in the midcontinent region has exceeded long-term sustainable levels for their arctic and subarctic breeding habitats and that the populations must be reduced. 50 CFR 21 provides authority for the management of overabundant, midcontinent light geese. On February 16, 1999, we published a final rule (64 FR 7517) that established a conservation order for midcontinent light geese (50 CFR 21.60). This regulation authorizes States and tribes in the midcontinent region to control midcontinent light geese within the United States through the use of alternative regulatory strategies. The conservation order authorizes States/tribes to implement population control measures without having to obtain a permit, thus significantly reducing their administrative burden. The conservation order is a streamlined process that affords an efficient and effective population reduction strategy, rather than addressing the issue through our permitting process. Furthermore, this strategy precludes the use of more drastic and costly direct population-reduction measures such as trapping and culling geese. States/tribes that participate in the conservation order must inform and brief all participants on the requirements in 50 CFR 21.60 and conservation order conditions that apply to the implementation of light geese control measures. Participating States/tribes must collect information on the number of birds taken during control efforts, the methods by which they were taken, and the date on which they were taken. We use this information to administer the conservation order and, particularly, to monitor the effectiveness of control strategies and to protect migratory birds. Each participating State/tribe must submit an annual report summarizing the activities it conducted. *Comments:* On April 25, 2008, we published in the Federal Register (73 FR 22429) a notice of our intent to request that OMB renew authority for this information collection. In that notice, we solicited public comments for 60 days, ending on June 24, 2008. We received one comment during this period. The commenter objected to the killing of geese and did not address the information collection requirements. We did not make any changes to our information collection as a result of this comment. We again invite comments concerning this information collection on:

(1)whether or not the collection of information is necessary, including whether or not the information will have practical utility;

(2)the accuracy of our estimate of the burden for this collection of information;

(3)ways to enhance the quality, utility, and clarity of the information to be collected; and

(4)ways to minimize the burden of the collection of information on respondents. Comments that you submit in response to this notice are a matter of public record. Before including your address, phone number, e-mail address, or other personal identifying information in your comment, you should be aware that your entire comment, including your personal identifying information, may be made publicly available at any time. While you can ask OMB in your comment to withhold your personal identifying information from public review, we cannot guarantee that it will be done. Hope Grey, Information Collection Clearance Officer, Fish and Wildlife Service. FR Doc. E8-14583 Filed 6-26-08; 8:45am BILLING CODE 4310-55-S DEPARTMENT OF THE INTERIOR Fish and Wildlife Service [FWS-R8-ES-2008-N0154; 80221-1113-0000-F5] Endangered Species Recovery Permit Applications AGENCY: Fish and Wildlife Service, Interior. ACTION: Notice of receipt of permit applications; request for comment. SUMMARY: We invite the public to comment on the following applications to conduct certain activities with endangered species. DATES: Comments on these permit applications must be received on or before July 28, 2008. ADDRESSES: Written data or comments should be submitted to the U.S. Fish and Wildlife Service, Endangered Species Program Manager, Region 8, 2800 Cottage Way, Room W-2606, Sacramento, CA 95825 (telephone: 916-414-6464; fax: 916-414-6486). Please refer to the respective permit number for each application when submitting comments. All comments received, including names and addresses, will become part of the official administrative record and may be made available to the public. FOR FURTHER INFORMATION CONTACT: Daniel Marquez, Fish and Wildlife Biologist, see ADDRESSES , (telephone: 760-431-9440; fax: 760-431-9624). SUPPLEMENTARY INFORMATION: The following applicants have applied for scientific research permits to conduct certain activities with endangered species pursuant to section 10(a)(1)(A) of the Endangered Species Act (16 U.S.C. 1531 *et seq.* ). The U.S. Fish and Wildlife Service (“we”) solicits review and comment from local, State, and Federal agencies, and the public on the following permit requests. Before including your address, phone number, e-mail address, or other personal identifying information in your comment, you should be aware that your entire comment—including your personal identifying information—may be made publicly available at any time. While you can ask us in your comment to withhold your personal identifying information from public review, we cannot guarantee that we will be able to do so. Permit No. TE-097845 *Applicant:* Mantech SRS Technologies, Lompoc, California. The applicant requests an amendment to take (capture, collect, and kill) the Conservancy fairy shrimp ( *Branchinecta conservatio* ), the longhorn fairy shrimp ( *Branchinecta longiantenna* ), the Riverside fairy shrimp ( *Streptocephalus wootoni* ), the San Diego fairy shrimp ( *Branchinecta sandiegonensis* ), and the vernal pool tadpole shrimp ( *Lepidurus packardi* ) in conjunction with surveys throughout the range of each species in California; and take (survey by pursuit) the El Segundo Blue butterfly ( *Euphilotes battoides allyni* ) in conjunction with surveys in Ventura and Santa Barbara Counties, California for the purpose of enhancing their survival. Permit No. TE-069171 *Applicant:* National Park Service, Thousand Oaks, California. The applicant requests an amendment to remove/reduce to possession the *Astragalus brauntonii* (Braunton's milkvetch) from federal lands in conjunction genetic research and taxonomic status studies throughout the range of the species in California, for the purpose of enhancing their survival. Permit No. TE-147533 *Applicant:* Jeffery J. Mitchell, San Francisco, California. The applicant requests an amendment to take (survey, capture, collect biological samples, and release) the California tiger salamander ( *Ambystoma californiense* ) in conjunction with biological research throughout the range of the species in California, for the purpose of enhancing its survival. Permit No. TE-185595 *Applicant:* Kelly E. Buja, Sacramento, California. The applicant requests a permit to take (capture, collect, and kill) the Conservancy fairy shrimp ( *Branchinecta conservatio* ), the longhorn fairy shrimp ( *Branchinecta longiantenna* ), the Riverside fairy shrimp ( *Streptocephalus wootoni* ), the San Diego fairy shrimp ( *Branchinecta sandiegonensis* ), and the vernal pool tadpole shrimp ( *Lepidurus packardi* ) in conjunction with surveys throughout the range of each species in California, for the purpose of enhancing their survival. We solicit public review and comment on each of these recovery permit applications. Comments and materials we receive will be available for public inspection, by appointment, during normal business hours at the address listed in the ADDRESSES section of this notice. Dated: June 23, 2008. Michael Fris, Acting Regional Director, Region 8, Sacramento, California. [FR Doc. E8-14581 Filed 6-26-08; 8:45 am] BILLING CODE 4310-55-P DEPARTMENT OF THE INTERIOR Bureau of Land Management [WY-100-08-1310-DB] Notice of Availability of a Final Supplemental Environmental Impact Statement for the Pinedale Anticline Oil and Gas Exploration and Development Project, Sublette County, WY AGENCY: Bureau of Land Management, Interior. ACTION: Notice of availability. SUMMARY: In accordance with the National Environmental Policy Act of 1969 (NEPA, 42 U.S.C. 4321 *et seq.* ) the Bureau of Land Management

(BLM)has prepared a Final Supplemental Environmental Impact Statement (FSEIS) that analyzes additional oil and gas development in the Pinedale Anticline Project Area (PAPA). DATES: The FSEIS will be available for review for 30 days following the date the Environmental Protection Agency publishes their Notice of Availability in the **Federal Register** . A Record of Decision

(ROD)will be prepared following the 30-day review period. FOR FURTHER INFORMATION, CONTACT: Caleb Hiner, BLM Project Manager, 768 West Pine Street, P.O. Box 768, Pinedale, Wyoming 82941. Electronic mail may be sent to: *Caleb_Hiner@blm.gov* with “PAPA FSEIS Information Request” in the subject line. The FSEIS will be posted at *http://www.blm.gov/wy/st/en/info/NEPA/pfodocs/anticline/seis.html* when available. SUPPLEMENTARY INFORMATION: The BLM conducted NEPA analysis and issued a ROD for the Pinedale Anticline Oil and Gas Exploration and Development Project in July 2000. The BLM conducted this analysis in response to increasing numbers of operators requesting approval to explore for and develop natural gas on the Pinedale Anticline. The 2000 PAPA ROD established protection of big game crucial winter ranges from oil and gas developments (well drilling and completion) during the winter months, and therefore did not include analysis of the potential impacts of oil and gas development activities (specifically drilling and completions) to big game on crucial winter ranges during the period of November 15 through April 30. The PAPA ROD provided that the BLM could grant limited exceptions to this winter closure period based on current conditions such as presence of wintering animals or depth of snow cover. Finally, the analysis in the PAPA EIS considered a total of 900 wells drilled with 700 producing well pads. The PAPA ROD stated that if the level of proposed development exceeds that analyzed in the EIS, BLM would conduct additional environmental analysis. There are currently approximately 460 producing wells in the PAPA. Starting in winter 2002-2003, the BLM authorized Questar Exploration and Development Company to continue winter gas development operations at one well pad within big game crucial winter range with the requirement that they work closely with the Wyoming Game and Fish Department in its study of impacts to the Sublette Mule Deer. Since then, other operators within the PAPA have expressed interest in conducting gas development activities including year-round drilling within big game crucial winter range. In summer 2005, Anschutz, Shell, and Ultra submitted a proposal to the BLM for year-round drilling demonstration project on three well pads within their leaseholds for one year. In September 2005, the BLM issued a Decision Record to allow them to proceed (ASU Year-Round Drilling Demonstration Project, September 2005). In 2005, BLM received a proposal for continued and expanded long-term development of natural gas resources in the PAPA from Questar Exploration and Production, Shell Exploration and Production Company, and Ultra Resources Inc. (‘The Operators’). The Operators proposed to conduct year-round drilling and completions in concentrated development areas within a core development area coinciding with the Anticline Crest in the PAPA. The Operators proposed an additional 4,399 wells on approximately 10-acre bottom hole spacing from an additional 250 well pads. The proposed development included construction of new well pads and substantial expansion of existing well pads to allow for multiple wells to be drilled from a pad. In addition, the BLM has determined that there is a need for new pipeline corridors between the PAPA and gas processing plants in southwestern Wyoming. Therefore, the FSEIS also includes analysis of potential new corridors. The PAPA encompasses approximately 198,034 acres of primarily Federal lands (nearly 80 percent), and State and private land. Approximately 83 percent of the mineral estate underlying the PAPA is federally-owned. The BLM has identified the following resources that may be adversely impacted by the proposal: surface and ground water resources; air quality; wildlife and their habitats; reclamation; visual resources; transportation; noxious weed control; grazing, cultural and paleontological resources; wetland and riparian resources; threatened and endangered animal and plant species; and socioeconomic resources. The BLM's Notice of Intent

(NOI)to prepare a SEIS was printed in the **Federal Register** on October 21, 2005. A Notice of Availability

(NOA)of the Draft SEIS was published in the **Federal Register** on December 15, 2006. The public comment period on the Draft SEIS closed in April 2006. Based upon public comment, the BLM determined two additional alternatives needed to be analyzed and made available for public review. A NOA for Revised Draft SEIS was published in the **Federal Register** on December 28, 2007. The comment period on the Revised Draft SEIS closed on February 11, 2008. The FSEIS describes and analyzes five alternatives, including the No Action Alternative and The Operators proposed action. A summary of the alternatives follows:

(A)The No Action Alternative would continue development on the Pinedale Anticline under the conditions imposed by the 2000 PAPA ROD. The Operator's proposal for year-round access would be denied. This alternative does not provide for full resource recovery.

(B)Alternative 2, The Operators proposed action, includes year-round development of up to 4,399 additional wells. Development would occur in three areas of concentrated development within a core area. Tier 2 equivalent emission controls would be installed on drilling rig engines in 29 of 48 drilling rigs in 2009. The Operators have also committed to 3:1 offsite mitigation for wildlife, if necessary.

(C)Alternative 3 considers the same project components as Alternative 2; however implementation would be phased spatially. It analyzes a smaller core area, with five areas of development; year-round access would be limited by area. The goal of Alternative 3 is to minimize surface disturbance in some areas while maximizing development in other areas. Air quality mitigation to reduce impacts in nearby sensitive areas is included in this alternative.

(D)Alternative 4, the BLM Preferred Alternative, is the result of comments received on the Draft SEIS. This alternative expands the core area slightly as compared to Alternatives 2 and 3, and delineates a potential development area around the core. Similar to Alternatives 2 and 3 the core area is broken into five development areas. The alternative also analyzes spatial phasing of development and applies Operator offered mitigation measures including Federal suspended leases and areas of no surface occupancy on areas outside the core of the PAPA. Adaptive management and a compensatory mitigation fund are also important elements of this alternative. Additional air quality mitigation is also included to further reduce impacts.

(E)Alternative 5 describes development of the full Operator proposed number of new wells (4,399) under conditions similar to the 2000 PAPA ROD, and without winter access in restricted wildlife habitats. James K. Murkin, Acting Associate State Director. [FR Doc. E8-14493 Filed 6-26-08; 8:45 am] BILLING CODE 4310-22-P DEPARTMENT OF THE INTERIOR Bureau of Land Management [CO-921-03-1320-EL; COC-73016] Notice of Invitation for Coal Exploration License Application, Peabody Coal Company, COC-73016; Colorado AGENCY: Bureau of Land Management, Interior. ACTION: Notice of Invitation for Coal Exploration License Application, Peabody Coal Company. SUMMARY: Pursuant to the Mineral Leasing Act of February 25, 1920, as amended, and to Title 43, Code of Federal Regulations, Subpart 3410, members of the public are hereby invited to participate with Peabody Coal Company, in a program for the exploration of unleased coal deposits owned by the United States of America containing approximately 3,980.0 acres in Morgan & Routt County, Colorado. DATES: Written Notice of Intent to Participate should be addressed to the attention of the following persons and must be received by them within 30 days after publication of this Notice of Invitation in the **Federal Register** . ADDRESSES: Kurt M. Barton, CO-921, Solid Minerals Staff, Division of Energy, Lands and Minerals, Colorado State Office, Bureau of Land Management, 2850 Youngfield Street, Lakewood, Colorado 80215; and, Peabody Coal Company, PO Box 373, St. Louis, MO 63166. SUPPLEMENTARY INFORMATION: The application for coal exploration license is available for public inspection during normal business hours under serial number COC-73016 at the Bureau of Land Management, Colorado State Office, 2850 Youngfield Street, Lakewood, Colorado 80215; and at the Little Snake Field Office, 455 Emerson St., Craig, Colorado 81625. Any party electing to participate in this program must share all costs on a pro rata basis with Peabody Coal Company, and with any other party or parties who elect to participate. Kurt M. Barton, Solid Minerals Staff, Division of Energy, Lands and Minerals. [FR Doc. E8-14614 Filed 6-26-08; 8:45 am] BILLING CODE 4310-JB-P DEPARTMENT OF THE INTERIOR Minerals Management Service Environmental Documents Prepared for Proposed Oil and Gas Operations on the Gulf of Mexico Outer Continental Shelf

(OCS)AGENCY: Minerals Management Service, Interior. ACTION: Notice of the Availability of Environmental Documents. Prepared for OCS Mineral Proposals on the Gulf of Mexico OCS. SUMMARY: Minerals Management Service (MMS), in accordance with Federal Regulations that implement the National Environmental Policy Act (NEPA), announces the availability of NEPA-related Site-Specific Environmental Assessments

(SEA)and Findings of No Significant Impact (FONSI), prepared by MMS for the following oil and gas activities proposed on the Gulf of Mexico OCS. FOR FURTHER INFORMATION CONTACT: Public Information Unit, Information Services Section at the number below. Minerals Management Service, Gulf of Mexico OCS Region, Attention: Public Information Office (MS 5034), 1201 Elmwood Park Boulevard, Room 114, New Orleans, Louisiana 70123-2394, or by calling 1-800-200-GULF. SUPPLEMENTARY INFORMATION: MMS prepares SEAs and FONSIs for proposals that relate to exploration for and the development/production of oil and gas resources on the Gulf of Mexico OCS. These SEAs examine the potential environmental effects of activities described in the proposals and present MMS conclusions regarding the significance of those effects. Environmental Assessments are used as a basis for determining whether or not approval of the proposals constitutes major Federal actions that significantly affect the quality of the human environment in the sense of NEPA Section 102(2)(C). A FONSI is prepared in those instances where MMS finds that approval will not result in significant effects on the quality of the human environment. The FONSI briefly presents the basis for that finding and includes a summary or copy of the SEA. This notice constitutes the public notice of availability of environmental documents required under the NEPA Regulations. This listing includes all proposals for which the Gulf of Mexico OCS Region prepared a FONSI in the period subsequent to publication of the preceding notice. Activity/operator Location Date Murphy Exploration and Production Company-USA, Initial Exploration Plan, SEA N-9060 De Soto Canyon, Block 838, Lease OCS-G 10475, located 95 miles from the nearest Louisiana shoreline 11/2/2007 Apache Corporation, Supplemental Exploration Plan, SEA S-7139 High Island, Block A-376, Lease OCS-G 02754, located 120 miles from the nearest Louisiana shoreline 1/8/2008 El Paso Production Oil & Gas Company, Structure Removal, SEA ES/SR 05-157A Vermilion, Block 102, Lease OCS-G 03393, located 29 miles from the nearest Louisiana shoreline 1/8/2008 El Paso Production Oil & Gas Company, Structure Removal, SEA ES/SR 06-092A Eugene Island, Block 53, Lease OCS-G 00479, located 15 miles from the nearest Louisiana shoreline 1/10/2008 W & T Offshore, Inc., Structure Removal, SEA ES/SR 07-160 Ship Shoal, Block 201, Lease OCS-G 05557, located 42 miles from the nearest Louisiana shoreline 1/10/2008 Energy Partners, LTD, Structure Removal, SEA ES/SR 07-090B High Island, Block 72, Lease OCS-G 22231, located 20 miles from the nearest Texas shoreline 1/12/2008 TGS-NOPEC Geophysical Company, Geological & Geophysical Prospecting for Mineral Resources, SEA T07-23 Located in the western Gulf of Mexico south of Freeport, Texas 1/12/2008 ATP Oil & Gas Corporation, Structure Removal, SEA ES/SR 07-154 Eugene Island (South Addition), Block 281, Lease OCS-G 09591, located 60 miles from the nearest Louisiana shoreline 1/14/2008 W & T Offshore, Inc., Structure Removal, SEA ES/SR 07-159 Ship Shoal, Block 202, Lease OCS-G 05558, located 42 miles from the nearest Louisiana shoreline 1/14/2008 Chevron U.S.A., Inc., Revised Exploration Plan, SEA R-4775 Atwater Valley, Block 138, Lease OCS-G 23018, located 79 miles south of Venice 1/16/2008 Maritech Resources, Inc., Structure Removal, SEA ES/SR 07-143 Eugene Island, Block 116, Lease OCS-G 00478, located 29 miles from the nearest Louisiana shoreline 1/17/2008 Hydro Gulf of Mexico, LLC, Structure Removal, SEA ES/SR 07-120 High Island, Block 202, Lease OCS-G 14870, located 33 miles from the nearest Texas shoreline 1/17/2008 ATP Oil & Gas Corporation, Structure Removal, SEA ES/SR 07-144 West Cameron, Block 194, Lease OCS-G 09402, located 28 miles from the nearest Louisiana shoreline 1/17/2008 Energy Resource Technology, Inc., Structure Removal, SEA ES/SR 06-009A Brazos, Block 452, Lease OCS-G 04713, located 13 miles from the nearest Texas 1/23/2008 Hydro Gulf of Mexico, LLC, Structure Removal, SEA ES/SR 07-126 High Island, Block 197, Lease OCS-G 22238, located 27 miles from the nearest Texas shoreline 1/25/2008 Arena Offshore, LLC, Structure Removal, SEA ES/SR APM HIA346-001 High Island, Block A346, Lease OCS-G 22272, located 112 miles from the nearest Louisiana shoreline 1/25/2008 Hunt Oil Company, Structure Removal, SEA ES/SR 08-004 High Island, Block A530, Lease OCS-G 18956, located 95 miles from the nearest Texas shoreline 1/25/2008 Hydro Gulf of Mexico, LLC, Structure Removal, SEA ES/SR 07-123 High Island, Block A7, Lease OCS-G 15781, located 33 miles from the nearest Texas shoreline 1/25/2008 Apache Corporation, Structure Removal, SEA ES/SR 07-153 Vermilion, Block 112, OCS-G 10659, located 29 miles from the nearest Louisiana shoreline 1/25/2008 Forest Oil Corporation, Structure Removal, SEA ES/SR 08-003 Vermilion, Block 35, Lease OCS-G 00549, located 7 miles from the nearest Louisiana shoreline 1/25/2008 ATP Oil & Gas Corporation, Structure Removal, SEA ES/SR 07-146 West Cameron, Block 101, Lease OCS-G 16115, located 13 miles from the nearest Louisiana shoreline 1/25/2008 EMSG America, Geological & Geophysical Prospecting for Mineral Resources, SEA T07-19 Located in the western Gulf of Mexico south of Galveston, Texas 1/31/2008 Apache Corporation, Structure Removal, SEA ES/SR 06-141A West Cameron, Block 48, Lease OCS-G 00768, located 18 miles from the nearest Louisiana shoreline 2/6/2008 Energy Resource Technology GOM, Inc., Structure Removal, SEA ES/SR 08-008 South Timbalier (South Addition), Block 235, Lease OCS-G 14544, located 47 miles from the nearest Louisiana shoreline 2/9/2008 Energy Resource Technology GOM, Inc., Structure Removal, SEA ES/SR 08-009 West Cameron, Block 488, Lease OCS-G 23774, located 83 miles from the nearest Louisiana shoreline 2/9/2008 Energy Resource Technology GOM, Inc., Structure Removal, SEA ES/SR 08-007 West Cameron (South Addition), Block 472, Lease OCS-G 22557, located 83 miles from the nearest Louisiana shoreline 2/11/2008 WesternGeco, LLC, Geological & Geophysical Prospecting for Mineral Resources, SEA L08-02 Located in the central Gulf of Mexico south of Fourchon, Louisiana 2/15/2008 SPN Resources, Structure Removal, SEA ES/SR 07-161, 07-162 Mobile, Block 861, Lease OCS-G 05062 & Block 819, Lease OCS-G 10920, located 3 to 7 miles from the nearest Alabama shoreline 2/15/2008 ATP Oil & Gas Corporation, Structure Removal, SEA ES/SR 07-145 West Cameron, Block 284, Lease OCS-G 17776, located 20 miles from the nearest Louisiana shoreline 2/15/2008 Devon Energy Production Company L.P., Structure Removal, SEA ES/SR 08-010 Eugene Island, Block 120, Lease OCS-G 00050, located 21 miles from the nearest Louisiana shoreline 2/22/2008 Chevron U.S.A., Inc., Structure Removal, SEA ES/SR 08-015 South Marsh, Block 8, Lease OCS-G 03401, located 32 miles from the nearest Louisiana shoreline 2/22/2008 Exxon Mobil Exploration Production Company, Geological & Geophysical Exploration for Mineral Resources, SEA L08-07 Located in the central Gulf of Mexico 75 miles south of Lafourche Parish, Louisiana 2/26/2008 Maritech Resources, Inc., Structure Removal, SEA ES/SR 99-121A West Cameron, Block 352, Lease OCS-G 02839, located 49 miles from the nearest Louisiana shoreline 2/26/2008 TGS-NOPEC Geophysical Company L.P., Geological & Geophysical Prospecting for Mineral Resources, SEA L08-03 Located in the central Gulf of Mexico south of Beaumont/Port Arthur, Texas 2/29/2008 Western GECO, LLC, Geological & Geophysical Prospecting for Mineral Resources, SEA L08-08 Located in the central Gulf of Mexico south of Venice, Louisiana 2/29/2008 WesternGeco, LLC, Geological & Geophysical Prospecting for Mineral Resources, SEA T08-01 Located in the western/central Gulf of Mexico south of Galveston, Texas 2/29/2008 Hunt Oil Company, Structure Removal, SEA ES/SR 08-019 Ship Shoal, Block 37, Lease OCS-G 26049, located 8 miles from the nearest Louisiana shoreline 3/4/2008 ATP Oil & Gas Corporation, Structure Removal, SEA ES/SR 08-001 Ship Shoal, Block 105, Lease OCS-G 09614, located 33 miles from the nearest Louisiana shoreline 3/6/2008 Maritech Resources, Inc., Structure Removal, SEA ES/SR 08-006 Ship Shoal, Block 291, Lease OCS-G 02923, located 58 miles from the nearest Louisiana shoreline 3/6/2008 Callon Petroleum Operating Company, Structure Removal, SEA ES/SR 08-020, 08-021 South Marsh Island (North Addition), Block 260, Lease OCS-G 02305, located 27 miles from the nearest Louisiana shoreline 3/6/2008 Walter Oil & Gas Corporation, Structure Removal, SEA ES/SR 02-098A Galveston, Block A218, Lease OCS-G 14152, located 74 miles from the nearest Texas shoreline 3/6/2008 CGG Veritas, Geological & Geophysical Prospecting for Mineral Resources, SEA L07-06 Located in the central Gulf of Mexico south of Fourchon, Louisiana 3/8/2008 LLOG Exploration Offshore, Inc., Structure Removal, SEA ES/SR 08-025 East Cameron, Block 81, Lease OCS-G 01477, located 27 miles from the nearest Louisiana shoreline 3/11/2008 Chevron U.S.A., Inc., Structure Removal, SEA ES/SR 08-024 Eugene Island, Block 338, Lease OCS-G 02118, located 76 miles from the nearest Louisiana shoreline 3/11/2008 Apache Corporation, Structure Removal, SEA ES/SR 07-155 South Timbalier, Block 161, Lease OCS-G 01248, located 32 miles from the nearest Louisiana shoreline 3/18/2008 Chevron U.S.A., Inc., Structure Removal, SEA ES/SR 08-023 Vermilion, Block 245B, Lease OCS-G 01146, located 67 miles from the nearest Louisiana shoreline 3/18/2008 Maritech Resources, Inc., Structure Removal, SEA ES/SR 06-163 West Cameron (South Addition), Block 528, Lease OCS-G 16202, located 91 miles from the nearest Louisiana shoreline 3/18/2008 W & T Offshore, Inc., Structure Removal, SEA ES/SR 08-016 Main Pass, Block 141, Lease OCS-G 09710, located 17 miles from the nearest Louisiana shoreline 3/19/2008 Petrobras America, Inc., Initial Development Operations Coordination Document, SEA N-9015 Walker Ridge, Blocks 206, 249 & 425, Leases OCS-G 16965, 16969 & 16987 respectfully, located 165 miles to the nearest Louisiana shoreline 3/20/2008 Millenium Offshore Group, Inc., on behalf of ATP Oil & Gas Corporation, Structure Removal, SEA ES/SR 08-041 Eugene Island, Block 190, Lease OCS-G 08434, located 35 miles from the nearest Louisiana shoreline 3/21/2008 McMoran Oil & Gas, LLC, Structure Removal, SEA ES/SR 08-029 Eugene Island, Block 203, Lease OCS-G 22670, located 50 miles from the nearest Louisiana shoreline 3/21/2008 Energy Resource Technology GOM, Inc., Structure Removal, SEA ES/SR 08-032, 08-033 South Pelto, Block 20, Lease OCS 00074, located 7 miles from the nearest Louisiana shoreline 3/24/2008 Apache Corporation, Structure Removal, SEA ES/SR 08-038, 08-039 High Island, Block 169, Lease OCS-G 14161, located 30 miles from the nearest Texas shoreline 3/24/2008 BP Exploration & Production, Inc., Revised Exploration Plan, SEA R-4803 AA Mississippi Canyon, Block 775, Lease OCS-G 19997, located 79 miles south of The Venice, Louisiana shoreline 3/25/2008 Stone Energy Corporation, Initial Exploration Plan, SEA N-9106 Main Pass, Block 72, Lease OCS-G 03417, located 6 miles from the nearest Plaquemines Parish, Louisiana shoreline 3/26/2008 Coastal Technology Corporation, Geological & Geophysical Prospecting for Mineral Resources, SEA E07-02 Located off the coast of St. Lucie County, Florida on the Federal OCS of the Atlantic Ocean 3/27/2008 GOM Shelf, LLC, Structure Removal, SEA ES/SR 08-040 Matagorda Island, Block 633, Lease OCS-G 06042, located 14 miles from the nearest Texas shoreline 3/27/2008 Energy Resource Technology, Structure Removal, SEA ES/SR 08-030, 08-031 South Pelto, Block 12, Lease OCS-G 00072, located 9 miles from the nearest Louisiana shoreline 3/27/2008 Apache Corporation, Structure Removal, SEA ES/SR 07-148, 07-149, 07-150 West Delta, Blocks 104 & 103, Leases OCS-G 00841 & 00840, located 27 miles from the nearest Louisiana shoreline 3/21/2008 Persons interested in reviewing environmental documents for the proposals listed above or obtaining information about SEAs and FONSIs prepared for activities on the Gulf of Mexico OCS are encouraged to contact MMS at the address or telephone listed in the FOR FURTHER INFORMATION CONTACT section. Dated: April 21, 2008. Lars Herbst, Regional Director, Gulf of Mexico OCS Region. [FR Doc. E8-14655 Filed 6-26-08; 8:45 am] BILLING CODE 4310-MR-P DEPARTMENT OF THE INTERIOR Minerals Management Service Notice on Outer Continental Shelf Oil and Gas Lease Sales AGENCY: Minerals Management Service, Interior. ACTION: Correction—List of Restricted Joint Bidders. SUMMARY: On April 22, 2008, pursuant to the authority vested in the Director of the Minerals Management Service by the joint bidding provisions of 30 CFR 256.41, as a matter of information to the public, the MMS published in the **Federal Register** the current List of Restricted Bidders. Under this authority, MMS determined that each entity within one of the following groups is restricted from bidding with any entity in any other of the following groups at Outer Continental Shelf oil and gas lease sales to be held during the bidding period May 1, 2008 through October 31, 2008. We inadvertently omitted a new group, “Group IX.,” that shall be restricted from bidding with any entity in any other group of restricted bidders during this bidding period. The corrected List of Restricted Joint Bidders is provided below and is effective as of the date of the previous **Federal Register** publication, April 22, 2008. Group I. Exxon Mobil Corporation ExxonMobil Exploration Company Group II. Shell Oil Company Shell Offshore, Inc. SWEPI LP Shell Frontier Oil & Gas, Inc. Shell Consolidated Energy Resources, Inc. Shell Land & Energy Company Shell Onshore Ventures, Inc. Shell Offshore Properties and Capital II, Inc. Shell Rocky Mountain Production, LLC Shell Gulf of Mexico, Inc. Group III. BP America Production Company BP Exploration & Production, Inc. BP Exploration (Alaska), Inc. Group IV. TOTAL E&P USA, Inc. Group V. Chevron Corporation Chevron U.S.A., Inc. Chevron Midcontinent, L.P. Unocal Corporation Union Oil Company of California Pure Partners, L.P. Group VI. ConocoPhillips Company ConocoPhillips Alaska, Inc. ConocoPhillips Petroleum Company Phillips Pt. Arguello Production Company Burlington Resources Oil & Gas Company, LP Burlington Resources Offshore, Inc. The Louisiana Land and Exploration Company Inexeco Oil Company Group VII. Eni Petroleum Co., Inc. Eni Petroleum US, LLC Eni Oil US, LLC Eni Marketing, Inc. Eni BB Petroleum, Inc. Eni U.S. Operating Co., Inc. Eni BB Pipeline, LLC Group VIII. Petrobras America, Inc. Group IX. StatoilHydro ASA Statoil Gulf of Mexico, LLC StatoilHydro USA E&P, Inc. StatoilHydro Gulf Properties, Inc. Dated: June 9, 2008. Randall B. Luthi, Director, Minerals Management Service. [FR Doc. E8-14654 Filed 6-26-08; 8:45 am] BILLING CODE 4310-MR-P INTERNATIONAL TRADE COMMISSION [Inv. No. 337-TA-565] In the Matter of: Certain Ink Cartridges and Components Thereof; Enforcement Proceeding II; Institution of Formal Enforcement Proceeding AGENCY: U.S. International Trade Commission. ACTION: Notice. SUMMARY: Notice is hereby given that the U.S. International Trade Commission has instituted a formal enforcement proceeding in the above-captioned investigation and named two enforcement respondents in the proceeding. FOR FURTHER INFORMATION CONTACT: Michael Haldenstein, Office of the General Counsel, U.S. International Trade Commission, 500 E Street, SW., Washington, DC 20436, telephone

(202)205-3041. Copies of all nonconfidential documents filed in connection with this investigation are or will be available for inspection during official business hours (8:45 a.m. to 5:15 p.m.) in the Office of the Secretary, U.S. International Trade Commission, 500 E Street, SW., Washington, DC 20436, telephone 202-205-2000. General information concerning the Commission may also be obtained by accessing its Internet server ( *http://www.usitc.gov* ). The public record for this investigation may be viewed on the Commission's electronic docket

(EDIS)at *http://edis.usitc.gov/* . Hearing-impaired persons are advised that information on the matter can be obtained by contacting the Commission's TDD terminal on 202-205-1810. SUPPLEMENTARY INFORMATION: The Commission instituted the underlying investigation in this matter on March 23, 2006, based on a complaint filed by Epson Portland, Inc. of Oregon; Epson America, Inc. of California; and Seiko Epson Corporation of Japan (collectively “Epson”). 71 FR. 14720 (March 23, 2006). The complaint, as amended, alleged violations of section 337 of the Tariff Act of 1930 (“section 337”) in the importation into the United States, the sale for importation, and the sale within the United States after importation of certain ink cartridges and components thereof by reason of infringement of claim 7 of U.S. Patent No. 5,615,957; claims 18, 81, 93, 149, 164 and 165 of U.S. Patent No. 5,622,439; claims 83 and 84 of U.S. Patent No. 5,158,377; claims 19 and 20 of U.S. Patent No. 5,221,148; claims 29, 31, 34 and 38 of U.S. Patent No. 5,156,472; claim 1 of U.S. Patent No. 5,488,401; claims 1-3 and 9 of U.S. Patent No. 6,502,917; claims 1, 31 and 34 of U.S. Patent No. 6,550,902; claims 1, 10 and 14 of U.S. Patent No. 6,955,422; claim 1 of U.S. Patent No. 7,008,053; and claims 21, 45, 53 and 54 of U.S. Patent No. 7,011,397. The complaint further alleged that an industry in the United States exists as required by subsection (a)(2) of section 337. The complainants requested that the Commission issue a general exclusion order and cease and desist orders. The Commission named as respondents 24 companies located in China, Germany, Hong Kong, Korea, and the United States. Several respondents were terminated from the investigation on the basis of settlement agreements or consent orders or were found in default. On March 30, 2007, the presiding administrative law judge

(ALJ)issued a final ID in the investigation finding a violation of section 337 with respect to certain respondents. He found the asserted claims valid and infringed by certain respondents' products. He recommended issuance of a general exclusion order and cease and desist orders directed to certain respondents and bond in the amount of $13.60 per cartridge during the Presidential review period. On October, 19, 2007, after review, the Commission made its final determination in the investigation, finding a violation of section 337. The Commission issued a general exclusion order, limited exclusion order, and cease and desist orders directed to several domestic respondents. The Commission also determined that the public interest factors enumerated in 19 U.S.C. 1337(d), (f), and

(g)did not preclude issuance of the aforementioned remedial orders, and that the bond during the Presidential review period would be $13.60 per cartridge for covered ink cartridges. On May 1, 2008, the Commission, based on two complaints filed by Epson on February 8, 2008, determined to institute a consolidated formal enforcement proceeding to determine whether certain respondents are in violation of the Commission's exclusion orders and cease and desist orders issued in the investigation, and what, if any, enforcement measures are appropriate. The following companies were named as respondents: Ninestar Technology Co., Ltd.; Ninestar Technology Company, Ltd.; Town Sky Inc.; Mipo America Ltd.; and Mipo International, Ltd. Based upon a third complaint filed by Epson on March 18, 2008, alleging violations of the general exclusion order and a consent order, the Commission has now determined to institute another formal enforcement proceeding to determine whether two respondents are in violation of the Commission's general exclusion order and a consent order issued in the investigation, and what, if any, enforcement measures are appropriate. The following entities are named as parties to the formal enforcement proceeding:

(1)Complainant Epson;

(2)respondents Ribbon Tree USA, Inc. (dba Cana-Pacific Ribbons) and Apex Distributing Inc; and

(3)a Commission investigative attorney to be designated by the Director, Office of Unfair Import Investigations. The authority for the Commission's determination is contained in section 337 of the Tariff Act of 1930, as amended (19 U.S.C. 1337), and in section 210.75 of the Commission's Rules of Practice and Procedure (19 CFR 210.75). Issued: June 23, 2008. By order of the Commission. Marilyn R. Abbott, Secretary to the Commission. [FR Doc. E8-14632 Filed 6-26-08; 8:45 am] BILLING CODE 7020-02-P DEPARTMENT OF JUSTICE Antitrust Division United States v. Verizon Communications Inc. and Rural Cellular Corporation; Proposed Final Judgment and Competitive Impact Statement Notice is hereby given pursuant to the Antitrust Procedures and Penalties Act, 15 U.S.C. 16(b)-(h), that a proposed Final Judgment, Stipulation, and Competitive Impact Statement have been filed with the United States District Court for the District of Columbia in *United States of America* v. *Verizon Communications Inc. and Rural Cellular Corporation,* Civil Action No. 08-cv-0993 (EGS). On June 10, 2008, the United States filed a Complaint alleging that the proposed acquisition by Verizon Communications Inc. (“Verizon”) of the wireless telecommunications services business of Rural Cellular Corporation (“RCC”) would violate Section 7 of the Clayton Act, 15 U.S.C. 18 by substantially lessening competition in the provision of mobile wireless telecommunications services in six

(6)geographic areas. The proposed Final Judgment, filed the same time as the Complaint, requires the divestiture of RCC's mobile wireless telecommunications services businesses in the state of Vermont and in certain areas in the states of New York and Washington in order for Verizon to proceed with its $2.67 billion acquisition of RCC. The Competitive Impact Statement filed by the United States describes the Complaint, the proposed Final Judgment, the industry, and the remedies available to private litigants who may have been injured by the alleged violation. Copies of the Complaint, proposed Final Judgment, and Competitive Impact Statement are available for inspection at the Department of Justice, Antitrust Division, Antitrust Documents Group, Suite 1010, Liberty Square Building, 450 5th Street, Washington, DC 20530 (telephone: 202-514-2481), on the Department of Justice's Web site at *http://www.usdoj.gov/atr,* and at the Office of the Clerk of the United States District Court for the District of Columbia. Copies of these materials may be obtained from the Antitrust Division upon request and payment of the copying fee set by the Department of Justice regulations. Public comment is invited within 60 days of the date of this notice. Such comments, and responses thereto, will be published in the **Federal Register** and filed with the Court. Comments should be directed to Nancy Goodman, Chief, Telecommunications and Media Enforcement Section, Antitrust Division, U.S. Department of Justice, 1401 H Street, NW., Suite 8000, Washington, DC 20530 (telephone: 202-514-5621). J. Robert Kramer II, Director of Operations, Antitrust Division. In the United States District Court for the District of Columbia *United States Of America, Department of Justice, Antitrust Division, 1401 H Street, NW., Suite 8000, Washington, DC 20530, and State of Vermont, Office of the Vermont Attorney General, 109 State Street, Montpelier, Vermont 056091001, Plaintiffs* , v. *Verizon Communications Inc., 140 West Street, New York, New York 1007, and Rural Cellular Corporation, 3905 Dakota Street SW., Alexandria, Minnesota 56308, Defendants* . Civil No. 1:08-cv-00993(EGS). Judge Emmet G. Sullivan. Filed: June 10, 2008. Complaint The United States of America, acting under the direction of the Attorney General of the United States, and the State of Vermont, by its Attorney General William H. Sorrell, bring this civil action to enjoin the merger of two mobile wireless telecommunications services providers, Verizon Communications Inc. (“Verizon”) and Rural Cellular Corporation (“RCC”), and to obtain other relief as appropriate. Plaintiffs allege as follows: 1. Verizon entered into an agreement to acquire RCC, dated July 29, 2007, under which the two companies would combine their mobile wireless telecommunications services businesses (“Transaction Agreement”). Plaintiffs seek to enjoin this transaction because it likely will substantially lessen competition to provide mobile wireless telecommunications services in several geographic markets where Verizon and RCC are each other's most significant competitor. 2. Verizon's mobile wireless telecommunications services network covers 263 million people in 49 states and serves in excess of 65 million subscribers. RCC provides mobile wireless telecommunications services in 15 states and serves approximately 790,000 subscribers. The combination of Verizon and RCC likely will substantially lessen competition for mobile wireless telecommunications services throughout Vermont, one geographic area in New York that is contiguous to Vermont, and in northeast Washington, where both Verizon and RCC currently operate. As a result of the proposed acquisition, residents of these areas will likely face increased prices, diminished quality or quantity of services, and less investment in network improvements for these services. I. Jurisdiction and Venue 3. This Complaint is filed by the United States under Section 15 of the Clayton Act, 15 U.S.C. 25, to prevent and restrain defendants from violating Section 7 of the Clayton Act, as amended, 15 U.S.C. § 18. Plaintiff Vermont, by and through its Attorney General, brings this action in its sovereign capacity and as parens patriae on behalf of the citizens, general welfare, and economy of the State of Vermont under Section 16 of the Clayton Act, 15 U.S.C. 26, to prevent defendants from violating Section 7 of the Clayton Act, 15 U.S.C. 18. 4. Verizon and RCC are engaged in interstate commerce and in activities substantially affecting interstate commerce. The Court has jurisdiction over this action pursuant to Sections 15 and 16 of the Clayton Act, 15 U.S.C. 25 and 26, and 28 U.S.C. 1331 and 1337. 5. The defendants have consented to personal jurisdiction and venue in this judicial district. II. The Defendants and the Transaction 6. Verizon, with headquarters in New York, is a corporation organized and existing under the laws of the State of Delaware. Verizon is one of the world's largest providers of communications services. Verizon is the second largest mobile wireless telecommunications services provider in the United States as measured by subscribers, provides mobile wireless telecommunications services in 49 states, and serves in excess of 65 million subscribers. In 2007, Verizon earned mobile wireless telecommunications services revenues of approximately $43 billion. 7. RCC, with headquarters in Alexandria, Minnesota, is a corporation organized and existing under the laws of the State of Minnesota. RCC is the 10th largest mobile wireless telecommunications services provider in the United States as measured by subscribers, and provides mobile wireless telecommunications services in 15 states. It has approximately 790,000 subscribers. In 2007, RCC earned approximately $635.3 million in revenues. 8. Pursuant to an Agreement and Plan of Merger dated July 29, 2007, Verizon will acquire RCC for approximately $267 billion. If this transaction is consummated, Verizon and RCC combined would have approximately 66 million subscribers in the United States, with $44 billion in mobile wireless telecommunications services revenues. III. Trade and Commerce A. Nature of Trade and Commerce 9. Mobile wireless telecommunications services allow customers to make and receive telephone calls and obtain data services using radio transmissions without being confined to a small area during the call or data session, and without the need for unobstructed line-of-sight to the radio tower. Mobility is highly valued by customers, as demonstrated by the more than 255 million people in the United States who own mobile wireless telephones. In 2007, revenues from the sale of mobile wireless telecommunications services in the United States were over $138 billion. To meet this desire for mobility, mobile wireless telecommunications services providers must deploy extensive networks of switches and radio transmitters and receivers and interconnect their networks with the networks of wireline earners and other mobile wireless telecommunications services providers. 10. In the early to mid-1980s, the FCC issued two cellular licenses (A-block and B-block) in each Metropolitan Statistical Area (“MSA”) and Rural Service Area (“RSA”) (collectively, “Cellular Marketing Areas” or “CMAs”), with a total of 734 CMAs covering the entire United States. Each license consists of 25 MHz of spectrum in the 800 MHz band. The first mobile wireless voice systems using this cellular spectrum were based on analog technology, now referred to as first-generation or “1 G” technology. 11. In 1995, the FCC licensed additional spectrum for the provision of Personal Communications Services (“PCS”), a category of services that includes mobile wireless telecommunications services comparable to those offered by cellular licensees. These licenses are in the 1900 MHz band and are divided into six blocks: A, B, and C, which consist of 30 MHz each; and D, E, and F, which consist of 10 MHz each. Geographically, the A and B-block 30 MHz licenses are issued by Major Trading Areas (“MTAs”). C, D, E, and F-block licenses are issued by Basic Trading Areas (“BTAs”), several of which comprise each MTA. MTAs and BTAs do not generally correspond to MSAs and RSAs. 12. With the introduction of the PCS licenses, both cellular and PCS licensees began offering digital services, thereby increasing network capacity, shrinking handsets, and extending battery life. In addition, in 1996, one provider, a specialized mobile radio (“SMR” or “dispatch”) spectrum licensee, began to use its SMR spectrum to offer mobile wireless telecommunications services comparable to those offered by other mobile wireless telecommunications services providers, in conjunction with its dispatch, or “push-to-talk,” service. Although there are a number of providers holding spectrum licenses in each area of the country, not all providers have fully built out their networks throughout each license area. In particular, because of the characteristics of PCS spectrum, providers holding this type of spectrum generally have found it less attractive to build out in rural areas. 13. Today, more than 95 percent of the total U.S. population lives in counties where three or more mobile wireless telecommunications services operators offer service. Nearly all mobile wireless voice services have migrated to second-generation or “2G” digital technologies, GSM (global standard for mobility), and CDMA (code division multiple access). Even more advanced technologies (“2.5G” and “3G”), based on the earlier 2G technologies, have been deployed for mobile wireless data services. B. Relevant Product Market 14. Mobile wireless telecommunications services is a relevant product market. Mobile wireless telecommunications services include both voice and data services provided over a radio network and allow customers to maintain their telephone calls or data sessions without wires when traveling. There are no cost-effective alternatives to mobile wireless telecommunications services. Because fixed wireless services are not mobile, they are not regarded by consumers of mobile wireless telecommunications services to be a reasonable substitute for those services. It is unlikely that a sufficient number of customers would switch away from mobile wireless telecommunications services to make a small but significant price increase in those services unprofitable. Mobile wireless telecommunications services accordingly is a relevant product market under Section 7 of the Clayton Act, 15 U.S.C. 18. C. Relevant Geographic Markets 15. The United States comprises numerous local geographic markets for mobile wireless telecommunications services. A large majority of customers use mobile wireless telecommunications services in close proximity to their workplaces and homes. Thus, customers purchasing mobile wireless telecommunications services choose among mobile wireless telecommunications services providers that offer services where they live, work, and travel on a regular basis. The geographic areas in which the FCC has licensed mobile wireless telecommunications services providers often represent the core of the business and social sphere within which customers have the same competitive choices for mobile wireless telephone services. The number and identity of mobile wireless telecommunications services providers varies among geographic areas, as does the quality of services and breadth of geographic coverage offered by providers. Some mobile wireless telecommunications services providers can and do offer different promotions, discounts, calling plans, and equipment subsidies in different geographic areas, varying the price for customers by geographic area. 16. The relevant geographic markets, under Section 7 of the Clayton Act, 15 U.S.C. 18, where the transaction will substantially lessen competition for mobile wireless telecommunications services are effectively represented by the following FCC spectrum licensing areas: Burlington, Vermont (CMA 248); New York RSA-2 (CMA 560); Vermont RSA-1 (CMA 679); Vermont RSA-2 (CMA 680); Washington RSA-2 (CMA 694); and Washington RSA-3 (CMA 695). It is unlikely that a sufficient number of customers would switch to mobile wireless telecommunications services providers who do not offer services in these geographic areas to make a small but significant price increase in the relevant geographic markets unprofitable. D. Anticompetitive Effects 1. Mobile Wireless Telecommunications Services 17. In each of the cellular license areas described above, Verizon and RCC are the two largest carriers (based on subscribers), with a combined share in each area ranging from over 60% to nearly 94%, and are each other's closest competitor for a significant set of customers. In all but a portion of one of these cellular license areas, Verizon and RCC hold all of the cellular spectrum licenses. 18. The relevant geographic markets for mobile wireless services are highly concentrated. As measured by the Herfindahl-Hirschman Index (“Hill”), which is commonly employed in merger analysis and is defined and explained in Appendix A to this Complaint, concentration in these geographic areas ranges from over 2800 to more than 5100, which is well above the 1800 threshold at which plaintiffs consider a market to be highly concentrated. After Verizon's proposed acquisition of RCC is consummated, the HHIs in the relevant geographic areas will range from over 4900 to over 8700, with increases in the HHI as a result of the merger ranging from over 1200 to over 4200, significantly beyond the thresholds at which plaintiffs consider a transaction likely to cause competitive harm. 19. Competition between Verizon and RCC in the relevant geographic markets has resulted in lower prices and higher quality in mobile wireless telecommunications services than would otherwise have existed in these geographic markets. In these areas, consumers consider Verizon and RCC to be particularly attractive competitors because other providers' networks lack coverage or provide lower-quality service. If Verizon's proposed acquisition of RCC is consummated, competition between Verizon and RCC in mobile wireless telecommunications services will be eliminated in these markets and the relevant markets for mobile wireless telecommunications services will become substantially more concentrated. As a result, the loss of competition between Verizon and RCC increases the merged firm's incentive and ability in the relevant geographic markets to increase prices, diminish the quality or quantity of services provided, and refrain from or delay making investments in network improvements. 2. Entry 20. Entry by a new mobile wireless services provider in the relevant geographic markets would be difficult, time-consuming, and expensive, requiring spectrum licenses and the build out of a network. Therefore, any entry in response to a small but significant price increase for mobile wireless telecommunications services by the merged firm in the relevant geographic markets would not be timely, likely, or sufficient to thwart the competitive harm resulting from Verizon's proposed acquisition of RCC, if it were to be consummated. IV. Violation Alleged 21. The effect of Verizon's proposed acquisition of RCC, if it were to be consummated, may be substantially to lessen competition in interstate trade and commerce in the relevant geographic markets for mobile wireless telecommunications services, in violation of Section 7 of the Clayton Act, 15 U.S.C. 18. 22. Unless restrained, the transaction will likely have the following effects in mobile wireless telecommunications services in the relevant geographic markets, among others: a. Actual and potential competition between Verizon and RCC will be eliminated; b. competition in general will be lessened substantially; c. prices are likely to increase; d. the quality and quantity of services are likely to decrease; and e. incentives to improve wireless networks will be reduced. V. Requested Relief The plaintiffs request: 23. That Verizon's proposed acquisition of RCC be adjudged to violate Section 7 of the Clayton Act, 15 U.S.C. 18; 24. That defendants be permanently enjoined from and restrained from carrying out the Agreement and Plan of Merger dated July 29, 2007, or from entering into or carrying out any agreement, understanding, or plan, the effect of which would be to bring the wireless services businesses of Verizon and RCC under common ownership or control; 25. That plaintiffs be awarded their costs of this action; and 26. That plaintiffs have such other relief as the Court may deem just and proper. Dated: Respectfully Submitted, For Plaintiff United States of America: Thomas O. Barnett, Assistant Attorney General, Antitrust Division; Nancy Goodman, Chief, Telecommunications & Media Enforcement Section, Antitrust Division; Deborah A. Garza, Deputy Assistant Attorney General, Antitrust Division; Laury Bobbish, Assistant Chief, Telecommunications & Media Enforcement Section, Antitrust Division; Patricia A. Brink, Deputy Director of Operations, Antitrust Division; Hillary B. Burchuk (DC Bar No. 366755), Lawrence M. Frankel (DC Bar No. 441532), Jared A. Hughes, Deborah Roy (DC Bar No. 452573), Attorneys, Telecommunications & Media Enforcement Section, Antitrust Division, U.S. Department of Justice, City Center Building, 1401 H Street, NW., Suite 8000, Washington, DC 20530, Phone:

(202)514-5621 Facsimile:

(202)514-6381. For Plaintiff State of Vermont: William H. Sorrell, Vermont Attorney General; Julie Brill, Assistant Attorney General and Director, Antitrust; Jennifer Giaimo, Assistant Attorney General, Office of the Vermont Attorney General, 109 State Street, Montpelier, Vermont 05609-1001,

(802)828-3658, Facsimile:

(802)828-2154. Appendix A Herfindahl-Hirschman Index “HHI” means the Herfindahl-Hirschman Index, a commonly accepted measure of market concentration. It is calculated by squaring the market share of each firm competing in the market and then summing the resulting numbers. For example, for a market consisting of four firms with shares of 30, 30, 20, and 20 percent, the HHI is 2600 (30 2 + 30 2 +20 2 + 20 2 = 2600). (Note: Throughout the Complaint, market share percentages have been rounded to the nearest whole number, but HHIs have been estimated using unrounded percentages in order to accurately reflect the concentration of the various markets.) The HHI takes into account the relative size distribution of the firms in a market and approaches zero when a market consists of a large number of small firms. The HHI increases both as the number of firms in the market decreases and as the disparity in size between those firms increases. Markets in which the HHI is between 1000 and 1800 points are considered to be moderately concentrated, and those in which the HHI is in excess of 1800 points are considered to be highly concentrated. *See Horizontal Merger Guidelines* ¶ 1.51 (revised Apr. 8, 1997). Transactions that increase the HHI by more than 100 points in concentrated markets presumptively raise antitrust concerns under the guidelines issued by the U.S. Department of Justice and Federal Trade Commission. *See id.* In the United States District Court for the District of Columbia *United States of America and State of Vermont, Plaintiffs* , v. *Verizon Communications Inc. and Rural Cellular Corporation, Defendants* . Case No. 1:08-cv-00993(EGS). Judge Emmet G. Sullivan. Filed: June 10, 2008. Final Judgment *Whereas,* plaintiffs, United States of America and the State of Vermont, filed their Complaint on June 10, 2008, plaintiffs and defendants, Verizon Communications Inc. (“Verizon”) and Rural Cellular Corporation (“RCC”), by their respective attorneys, have consented to the entry of this Final Judgment without trial or adjudication of any issue of fact or law, and without this Final Judgment constituting any evidence against or admission by any party regarding any issue of fact or law; *And whereas,* defendants agree to be bound by the provisions of this Final Judgment pending its approval by the Court; *And whereas,* the essence of this Final Judgment is the prompt and certain divestiture of certain rights or assets by defendants to assure that competition is not substantially lessened; *And whereas,* plaintiffs require defendants to make certain divestitures for the purpose of remedying the loss of competition alleged in the Complaint; *And whereas,* defendants have represented to plaintiffs that the divestitures required below can and will be made and that defendants will later raise no claim of hardship or difficulty as grounds for asking the Court to modify any of the divestiture provisions contained below; *Now therefore* , before any testimony is taken, without trial or adjudication of any issue of fact or law, and upon consent of the parties, it is *ordered, adjudged and decreed* : I. Jurisdiction This Court has jurisdiction over the subject matter of and each of the parties to this action. The Complaint states a claim upon which relief may be granted against defendants under Section 7 of the Clayton Act, as amended (15 U.S.C. 18). II. Definitions As used in this Final Judgment: A. “Acquirer” or “Acquirers” means the entity or entities to whom defendants divest the Divestiture Assets. B. “CMA” means cellular market area which is used by the Federal Communications Commission (“FCC”) to define cellular license areas and which consists of Metropolitan Statistical Areas (“MSAs”) and Rural Service Areas (“RSAs”) C. “Divestiture Assets” means each mobile wireless telecommunications services business to be divested under this Final Judgment, including all types of assets, tangible and intangible, used by defendants in the operation of the mobile wireless telecommunications services businesses to be divested. “Divestiture Assets” shall be construed broadly to accomplish the complete divestiture of the entire business of RCC in each of the following CMA license areas as required by this Final Judgment and to ensure that the divested mobile wireless telecommunications services businesses remain viable, ongoing businesses:

(1)Burlington, VT MSA (CMA 248);

(2)New York RSA 2 (CMA 560);

(3)Vermont RSA 1 (CMA 679);

(4)Vermont RSA 2 (CMA 680);

(5)Washington RSA 2 (CMA 694); and

(6)Washington RSA 3 (CMA 695); provided that defendants may retain all of the PCS spectrum licenses RCC currently holds in each of these CMAs, except in the Burlington MSA, and equipment that is used only for wireless transmissions over this PCS spectrum. Defendants may also retain the Ericsson AXE 810 switch located in Colchester, VT used to support the GSM mobile wireless telecommunications services currently provided by RCC; the Lucent 5E switch located in Colchester, VT used to support CDMA, TDMA and analog mobile wireless telecommunications services currently provided by RCC; the CDMA, TDMA and analog equipment on the radio tower located at Woodstock (latitude 43.613975, longitude -72.52175) and any associated rights for this equipment to remain on this tower currently owned and held by RCC; and the CDMA equipment located on the radio tower located at Stratton (latitude 43.11344, longitude -72.90691) and any associated rights for this equipment to remain on this tower currently owned and held by RCC. In addition, defendants also

(i)may retain in the Burlington MSA, RCC's PCS spectrum license, and

(ii)in the Vermont RSA 2-B2 service area, which includes Bennington and Windham counties, and the portion of Windsor county south of U.S. Route 4, may substitute a license for 10 MHz of RCC's cellular spectrum for RCC's 10 MHz PCS spectrum license, if approved by plaintiff United States in its sole discretion, upon consultation with plaintiff Vermont. The Divestiture Assets shall include, without limitation, all types of real and personal property, monies and financial instruments, equipment, inventory, office furniture, fixed assets and furnishings, supplies and materials, contracts, agreements, leases, commitments, spectrum licenses issued by the FCC and all other licenses, permits and authorizations, operational support systems, cell sites, network infrastructure, switches, customer support and billing systems, interfaces with other service providers, business and customer records and information, customer contracts, customer lists, credit records, accounts, and historic and current business plans that relate primarily to the wireless businesses being divested, as well as any patents, licenses, sub-licenses, trade secrets, know-how, drawings, blueprints, designs, technical and quality specifications and protocols, quality assurance and control procedures, manuals and other technical information defendant RCC supplies to its own employees, customers, suppliers, agents, or licensees, and trademarks, trade names and service marks or other intellectual property, including all intellectual property rights under third-party licenses that are capable of being transferred to the Acquirer(s) either in their entirety, for assets described in

(a)below, or through a license obtained through or from RCC, for assets described in

(b)below; provided that defendants shall only be required to divest Multi-line Business Customer contracts if the primary business address for that customer is located within any of the six license areas described herein, and further, any subscriber who obtains mobile wireless telecommunications services through any such contract retained by defendants and who are located within the six license areas identified above, shall be given the option to terminate their relationship with defendants, without financial cost, at any time within one year of the closing of the Transaction. Defendants shall provide written notice to these subscribers within 45 days after the closing of the Transaction of the option to terminate. The divestiture of the Divestiture Assets shall be accomplished by:

(a)transferring to the Acquirer(s) the complete ownership and/or other rights to the assets (other than those assets used substantially in the operations of RCC's overall wireless telecommunications services business that must be retained to continue the existing operations of the wireless properties that defendants are not required to divest, and that either are not capable of being divided between the divested wireless telecommunications services businesses and those not divested, or are assets that the defendants and the Acquirer(s) agree, subject to the approval of plaintiff United States, shall not be divided); and

(b)granting to the Acquirer(s) an option to obtain a nonexclusive, transferable license from defendants for a reasonable period, subject to the approval of plaintiff United States, and at the election of the Acquirer(s), to use any of RCC's retained assets under paragraph

(a)above used in operating the mobile wireless telecommunications services businesses being divested, so as to enable the Acquirer(s) to continue to operate the divested mobile wireless telecommunications services businesses without impairment. Defendants shall identify in a schedule submitted to plaintiff United States and filed with the Court as expeditiously as possible following the filing of the Complaint, and in any event prior to any divestiture and before the approval by the Court of this Final Judgment, any and all intellectual property rights under third-party licenses that are used by the mobile wireless telecommunications services businesses being divested that defendants could not transfer to the Acquirer(s) entirely or by license without third-party consent, the specific reasons why such consent is necessary, and how such consent would be obtained for each asset. D. “Multi-line Business Customer” means a corporate or business customer that contracts with RCC for mobile wireless telecommunications services to provide multiple telephones to its employees or members whose services are provided pursuant to a contract with the corporate or business customer. E. “RCC” means defendant Rural Cellular Corporation, a Minnesota corporation with its headquarters in Alexandria, Minnesota, its successors and assigns, and its subsidiaries, divisions, groups, affiliates, partnerships and joint ventures, and their directors, officers, managers, agents, and employees. F. “Transaction” means the Agreement and Plan of Merger, dated July 29, 2007. G. “Verizon” means defendant Verizon Communications Inc., a Delaware corporation, with its headquarters in New York, New York, its successors and assigns, and its subsidiaries, divisions, groups, affiliates, partnerships and joint ventures, and their directors, officers, managers, agents, and employees. III. Applicability A. This Final Judgment applies to defendants Verizon and RCC, as defined above, and all other persons in active concert or participation with any of them who receive actual notice of this Final Judgment by personal service or otherwise. B. If, prior to complying with Section IV and V of this Final Judgment, Defendants sell or otherwise dispose of all or substantially all of their assets or of lesser business units that include the Divestiture Assets, they shall require the purchaser to be bound by the provisions of this Final Judgment. Defendants need not obtain such an agreement from the acquirer(s) of the assets divested pursuant to this Final Judgment. IV. Divestitures A. Defendants are ordered and directed, within 120 days after consummation of the Transaction, or five

(5)calendar days after notice of the entry of this Final Judgment by the Court, whichever is later, to divest the Divestiture Assets in a manner consistent with this Final Judgment to an Acquirer or Acquirers acceptable to plaintiff United States in its sole discretion, and with respect to the Divestiture Assets located in Vermont upon consultation with plaintiff Vermont, or, if applicable, to a Divestiture Trustee designated pursuant to Section V of this Final Judgment. Plaintiff United States, in its sole discretion, and with respect to the Divestiture Assets located in Vermont upon consultation with plaintiff Vermont, may agree to one or more extensions of this time period not to exceed 60 calendar days in total, and shall notify the Court in such circumstances. With respect to divestiture of the Divestiture Assets by defendants or the Divestiture Trustee, if applications have been filed or are on file with the FCC within the period permitted for divestiture seeking approval to assign or transfer licenses to the Acquirer(s) of the Divestiture Assets, but an order or other dispositive action by the FCC on such applications has not been issued before the end of the period permitted for divestiture, the period shall be extended with respect to divestiture of those Divestiture Assets for which FCC approval has not been issued until five

(5)days after such approval is received. Defendants agree to use their best efforts to accomplish the divestitures set forth in this Final Judgment and to seek all necessary regulatory approvals as expeditiously as possible. This Final Judgment does not limit the FCC's exercise of its regulatory powers and process with respect to the Divestiture Assets. Authorization by the FCC to conduct the divestiture of a Divestiture Asset in a particular manner will not modify any of the requirements of this decree. B. In accomplishing the divestitures ordered by this Final Judgment, defendants shall promptly make known, if they have not already done so, by usual and customary means, the availability of the Divestiture Assets. Defendants shall inform any person making inquiry regarding a possible purchase of the Divestiture Assets that they are being divested pursuant to this Final Judgment and provide that person with a copy of this Final Judgment. Defendants shall offer to furnish to all prospective Acquirers, subject to customary confidentiality assurances, all information and documents relating to the Divestiture Assets customarily provided in a due diligence process except such information or documents subject to the attorney-client or work product privileges. Defendants shall make available such information to plaintiffs at the same time that such information is made available to any other person. Notwithstanding the provisions of this paragraph, with the consent of plaintiff United States in its sole discretion, and with respect to the Divestiture Assets located in Vermont upon consultation with plaintiff Vermont, the defendants may enter into exclusive negotiations to sell the Divestiture Assets and may limit their obligations under this paragraph to the provision of information to a single potential buyer for the duration of those negotiations. C. Defendants shall provide the Acquirer(s) and plaintiffs information relating to the personnel involved in the operation, development, and sale or license of the Divestiture Assets to enable the Acquirer(s) to make offers of employment. Defendants will not interfere with any negotiations by the Acquirer(s) to employ any defendant employee whose primary responsibility is the operation, development, or sale or license of the Divestiture Assets. D. Defendants shall permit prospective Acquirers of the Divestiture Assets to have reasonable access to personnel and to make inspections of the Divestiture Assets; access to any and all environmental, zoning, and other permit documents and information; and access to any and all financial, operational, and other documents and information customarily provided as part of a due diligence process. E. Defendants shall warrant to the Acquirer(s) that

(1)the Divestiture Assets will be operational on the date of sale, and

(2)every wireless spectrum license is in full force and effect on the date of sale. F. Defendants shall not take any action that will impede in any way the permitting, licensing, operation, or divestiture of the Divestiture Assets. G. Defendants shall warrant to the Acquirer(s) of the Divestiture Assets that there are no material defects in the environmental, zoning, licensing or other permits pertaining to the operation of each asset and that following the sale of the Divestiture Assets, defendants will not undertake, directly or indirectly, any challenges to the environmental, zoning, licensing or other permits relating to the operation of the Divestiture Assets. H. Unless plaintiff United States, and with respect to the Divestiture Assets located in Vermont upon consultation with plaintiff Vermont, otherwise consents in writing, the divestitures pursuant to Section IV, or by a Divestiture Trustee appointed pursuant to Section V, of this Final Judgment, shall include the entire Divestiture Assets, and shall be accomplished in such a way as to satisfy plaintiff United States in its sole discretion that these assets can and will be used by the Acquirer(s) as part of a viable, ongoing business engaged in the provision of mobile wireless telecommunications services. The Divestiture Assets in Vermont and New York shall all be divested to a single Acquirer and the Divestiture Assets in Washington shall all be divested to a single Acquirer, provided that it is demonstrated to the sole satisfaction of plaintiff United States, and with respect to the Divestiture Assets located in Vermont upon consultation with plaintiff Vermont, that the Divestiture Assets will remain viable and the divestiture of such assets will remedy the competitive harm alleged in the Complaint. The divestiture of the Divestiture Assets, whether pursuant to Section IV or Section V of this Final Judgment,

(1)shall be made to an Acquirer or Acquirers that, in plaintiff United States's sole judgment, and with respect to the Divestiture Assets located in Vermont upon consultation with plaintiff Vermont, has the intent and capability (including the necessary managerial, operational, technical, and financial capability) of competing effectively in the provision of mobile wireless telecommunications services; and

(2)shall be accomplished so as to satisfy plaintiff United States in its sole discretion, and with respect to the Divestiture Assets located in Vermont upon consultation with plaintiff Vermont, that none of the terms of any agreement between an Acquirer(s) and defendants shall give defendants the ability unreasonably to raise the Acquirer's costs, to lower the Acquirer's efficiency, or otherwise to interfere with the ability of the Acquirer to compete effectively. I. At the option of the Acquirer(s) of the Divestiture Assets, defendants shall enter into a contract for transition services customarily provided in connection with the sale of a business providing mobile wireless telecommunications services or intellectual property licensing sufficient to meet all or part of the needs of the Acquirer(s) for a period of up to one year. The terms and conditions of any contractual arrangement meant to satisfy this provision must be reasonably related to market conditions. J. To the extent that the Divestiture Assets use intellectual property, as required to be identified by Section II.C, that cannot be transferred or assigned without the consent of the licensor or other third parties, defendants shall use their best efforts to obtain those consents. V. Appointment of Divestiture Trustee A. If defendants have not divested the Divestiture Assets within the time period specified in Section IV.A, defendants shall notify plaintiff United States, and with respect to the Divestiture Assets located in Vermont notify plaintiff Vermont of that fact in writing, specifically identifying the Divestiture Assets that have not been divested. Upon application of plaintiff United States, and with respect to the Divestiture Assets located in Vermont upon consultation with plaintiff Vermont, the Court shall appoint a Divestiture Trustee selected by plaintiff United States and approved by the Court to effect the divestiture of the Divestiture Assets. The Divestiture Trustee will have all the rights and responsibilities of the Management Trustee who may be appointed pursuant to the Preservation of Assets Stipulation and Order, and will be responsible for:

(1)accomplishing divestiture of all Divestiture Assets transferred to the Divestiture Trustee from defendants, in accordance with the terms of this Final Judgment, to an Acquirer(s) approved by plaintiff United States, and with respect to the Divestiture Assets located in Vermont upon consultation with plaintiff Vermont, under Section IV.A of this Final Judgment; and

(2)exercising the responsibilities of the licensee of any transferred Divestiture Assets and controlling and operating any transferred Divestiture Assets, to ensure that the businesses remain ongoing, economically viable competitors in the provision of mobile wireless telecommunications services in the license areas specified in Section II.C, until they are divested to an Acquirer(s), and the Divestiture Trustee shall agree to be bound by this Final Judgment. B. Defendants shall submit a proposed trust agreement (“Trust Agreement”) to plaintiff United States, which must be consistent with the terms of this Final Judgment and which must receive approval by plaintiff United States in its sole discretion, and with respect to the Divestiture Assets located in Vermont upon consultation with plaintiff Vermont, who shall communicate to defendants within 10 business days its approval or disapproval of the proposed Trust Agreement, and which must be executed by the defendants and the Divestiture Trustee within five business days after approval by plaintiff United States. C. After obtaining any necessary approvals from the FCC for the assignment of the licenses of the Divestiture Assets to the Divestiture Trustee, defendants shall irrevocably divest the remaining Divestiture Assets to the Divestiture Trustee, who will own such assets (or own the stock of the entity owning such assets, if divestiture is to be effected by the creation of such an entity for sale to Acquirer) and control such assets, subject to the terms of the approved Trust Agreement. D. After the appointment of a Divestiture Trustee becomes effective, only the Divestiture Trustee shall have the right to sell the Divestiture Assets. The Divestiture Trustee shall have the power and authority to accomplish the divestiture to an Acquirer(s) acceptable to plaintiff United States, in its sole judgment, and with respect to the Divestiture Assets located in Vermont upon consultation with plaintiff Vermont, at such price and on such terms as are then obtainable upon reasonable effort by the Divestiture Trustee, subject to the provisions of Sections IV, V, and VI of this Final Judgment, and shall have such other powers as this Court deems appropriate. Subject to Section V.G of this Final Judgment, the Divestiture Trustee may hire at the cost and expense of defendants the Management Trustee appointed pursuant to the Preservation of Assets Stipulation and Order and any investment bankers, attorneys or other agents, who shall be solely accountable to the Divestiture Trustee, reasonably necessary in the Divestiture Trustee's judgment to assist in the divestiture. E. In addition, notwithstanding any provision to the contrary, plaintiff United States, in its sole discretion, and with respect to the Divestiture Assets located in Vermont upon consultation with plaintiff Vermont, may require defendants to include additional assets, or with the written approval of plaintiff United States, allow defendants to substitute substantially similar assets, which substantially relate to the Divestiture Assets to be divested by the Divestiture Trustee to facilitate prompt divestiture to an acceptable Acquirer(s). F. Defendants shall not object to a sale by the Divestiture Trustee on any ground other than the Divestiture Trustee's malfeasance. Any such objections by defendants must be conveyed in writing to plaintiff United States and the Divestiture Trustee within 10 calendar days after the Divestiture Trustee has provided the notice required under Section VI. G. The Divestiture Trustee shall serve at the cost and expense of defendants, on such terms and conditions as plaintiff United States approves, and shall account for all monies derived from the sale of the assets sold by the Divestiture Trustee and all costs and expenses so incurred. After approval by the Court of the Divestiture Trustee's accounting, including fees for its services and those of any professionals and agents retained by the Divestiture Trustee, all remaining money shall be paid to defendants and the trust shall then be terminated. The compensation of the Divestiture Trustee and any professionals and agents retained by the Divestiture Trustee shall be reasonable in light of the value of the Divestiture Assets and based on a fee arrangement providing the Divestiture Trustee with an incentive based on the price and terms of the divestiture, and the speed with which it is accomplished, but timeliness is paramount. H. Defendants shall use their best efforts to assist the Divestiture Trustee in accomplishing the required divestitures, including their best efforts to effect all necessary regulatory approvals. The Divestiture Trustee and any consultants, accountants, attorneys, and other persons retained by the Divestiture Trustee shall have full and complete access to the personnel, books, records, and facilities of the businesses to be divested, and defendants shall develop financial and other information relevant to the assets to be divested as the Divestiture Trustee may reasonably request, subject to reasonable protection for trade secret or other confidential research, development, or commercial information. Defendants shall take no action to interfere with or to impede the Divestiture Trustee's accomplishment of the divestitures. I. After its appointment, the Divestiture Trustee shall file monthly reports with plaintiff United States, and with respect to the Divestiture Assets located in Vermont with plaintiff Vermont, and the Court setting forth the Divestiture Trustee's efforts to accomplish the divestitures ordered under this Final Judgment. To the extent such reports contain information that the Divestiture Trustee deems confidential, such reports shall not be filed in the public docket of the Court. Such reports shall include the name, address, and telephone number of each person who, during the preceding month, made an offer to acquire, expressed an interest in acquiring, entered into negotiations to acquire, or was contacted or made an inquiry about acquiring, any interest in the Divestiture Assets, and shall describe in detail each contact with any such person. The Divestiture Trustee shall maintain full records of all efforts made to divest the Divestiture Assets. J. If the Divestiture Trustee has not accomplished the divestitures ordered under the Final Judgment within six months after its appointment, the Divestiture Trustee shall promptly file with the Court a report setting forth

(1)The Divestiture Trustee's efforts to accomplish the required divestitures,

(2)the reasons, in the Divestiture Trustee's judgment, why the required divestitures have not been accomplished, and

(3)the Divestiture Trustee's recommendations. To the extent such reports contain information that the Divestiture Trustee deems confidential, such reports shall not be filed in the public docket of the Court The Divestiture Trustee shall at the same time furnish such report to plaintiff United States, and with respect to the Divestiture Assets located in Vermont to plaintiff Vermont, who shall have the right to make additional recommendations consistent with the purpose of the trust. The Court thereafter shall enter such orders as it shall deem appropriate to carry out the purpose of the Final Judgment, which may, if necessary, include extending the trust and the term of the Divestiture Trustee's appointment by a period requested by plaintiff United States, and with respect to the Divestiture Assets located in Vermont upon consultation with plaintiff Vermont. K. After defendants transfer the Divestiture Assets to the Divestiture Trustee, and until those Divestiture Assets have been divested to an Acquirer or Acquirers approved by plaintiff United States pursuant to Sections IV.A and IV.H, the Divestiture Trustee shall have sole and complete authority to manage and operate the Divestiture Assets and to exercise the responsibilities of the licensee and shall not be subject to any control or direction by defendants. Defendants shall not use, or retain any economic interest in, the Divestiture Assets transferred to the Divestiture Trustee, apart from the right to receive the proceeds of the sale or other disposition of the Divestiture Assets. L. The Divestiture Trustee shall operate the Divestiture Assets consistent with the Preservation of Assets Stipulation and Order and this Final Judgment, with control over operations, marketing, and sales. Defendants shall not attempt to influence the business decisions of the Divestiture Trustee concerning the operation and management of the Divestiture Assets, and shall not communicate with the Divestiture Trustee concerning divestiture of the Divestiture Assets or take any action to influence, interfere with, or impede the Divestiture Trustee's accomplishment of the divestitures required by this Final Judgment, except that defendants may communicate with the Divestiture Trustee to the extent necessary for defendants to comply with this Final Judgment and to provide the Divestiture Trustee, if requested to do so, with whatever resources or cooperation may be required to complete divestiture of the Divestiture Assets and to carry out the requirements of the Preservation of Assets Stipulation and Order and this Final Judgment. Except as provided in this Final Judgment and the Preservation of Assets Stipulation and Order, in no event shall defendants provide to, or receive from, the Divestiture Trustee or the mobile wireless telecommunications services businesses any non-public or competitively sensitive marketing, sales, pricing or other information relating to their respective mobile wireless telecommunications services businesses. VI. Notice of Proposed Divestitures A. Within the later of two

(2)business days following

(i)the execution of a definitive divestiture agreement, or

(ii)the filing of the Complaint in this action, defendants or the Divestiture Trustee, whichever is then responsible for effecting the divestitures required herein, shall notify plaintiff United States, and with respect to the Divestiture Assets located in Vermont defendants shall notify plaintiff Vermont, in writing of any proposed divestiture required by Section IV or V of this Final Judgment. If the Divestiture Trustee is responsible, it shall similarly notify defendants. The notice shall set forth the details of the proposed divestiture and list the name, address, and telephone number of each person not previously identified who offered or expressed an interest in or desire to acquire any ownership interest in the Divestiture Assets, together with full details of the same. B. Within fifteen

(15)calendar days of receipt of notice by plaintiff United States and plaintiff Vermont, if notice was given to plaintiff Vermont, plaintiff United States and plaintiff Vermont if it received notice, may request from defendants, the proposed Acquirer, any other third party, or the Divestiture Trustee, if applicable, additional information concerning the proposed divestiture, the proposed Acquirer, and any other potential Acquirer. Defendants and the Divestiture Trustee shall furnish any additional information requested within fifteen

(15)calendar days of the receipt of the request, unless the parties shall otherwise agree. C. Within thirty

(30)calendar days after receipt of the notice or within twenty

(20)calendar days after plaintiff United States and plaintiff Vermont have been provided the additional information requested from defendants, the proposed Acquirer, any third party, and the Divestiture Trustee, whichever is later, plaintiff United States, and with respect to the Divestiture Assets located in Vermont upon consultation with plaintiff Vermont, shall provide written notice to defendants and the Divestiture Trustee, if there is one, stating whether or not it objects to the proposed divestiture. If plaintiff United States provides written notice that it does not object, the divestiture may be consummated, subject only to defendants' limited right to object to the sale under Section V.F of this Final Judgment. Absent written notice that plaintiff United States does not object to the proposed Acquirer or upon objection by plaintiff United States, a divestiture proposed under Section IV or Section V shall not be consummated. Upon objection by defendants under Section V.F, a divestiture proposed under Section V shall not be consummated unless approved by the Court. VII. Financing Defendants shall not finance all or any part of any divestiture made pursuant to Section IV or V of this Final Judgment. VIII. Preservation of Assets Until the divestitures required by this Final Judgment have been accomplished, defendants shall take all steps necessary to comply with the Preservation of Assets Stipulation and Order entered by this Court and cease use of the Divestiture Assets during the period that the Divestiture Assets are managed by the Management Trustee. Defendants shall take no action that would jeopardize the divestitures ordered by this Court. IX. Affidavits A. Within twenty

(20)calendar days of the filing of the Complaint in this matter, and every thirty

(30)calendar days thereafter until the divestitures have been completed under Section IV or V, defendants shall deliver to plaintiffs an affidavit as to the fact and manner of its compliance with Section IV or V of this Final Judgment. Each such affidavit shall include the name, address, and telephone number of each person who during the preceding thirty

(30)calendar days, made an offer to acquire, expressed an interest in acquiring, entered into negotiations to acquire, or was contacted or made an inquiry about acquiring, any interest in the Divestiture Assets, and shall describe in detail each contact with any such person during that period. Each such affidavit shall also include a description of the efforts defendants have taken to solicit buyers for the Divestiture Assets, and to provide required information to prospective Acquirers, including the limitations, if any, on such information. Assuming the information set forth in the affidavit is true and complete, any objection by plaintiff United States, and with respect to Divestiture Assets located in Vermont upon consultation with plaintiff Vermont, to information provided by defendants, including limitation on information, shall be made within fourteen

(14)calendar days of receipt of such affidavit. B. Within twenty

(20)calendar days of the filing of the Complaint in this matter, defendants shall deliver to plaintiffs an affidavit that describes in reasonable detail all actions defendants have taken and all steps defendants have implemented on an ongoing basis to comply with Section VIII of this Final Judgment. Defendants shall deliver to plaintiffs an affidavit describing any changes to the efforts and actions outlined in defendants' earlier affidavits filed pursuant to this section within fifteen

(15)calendar days after the change is implemented. C. Defendants shall keep all records of all efforts made to preserve and divest the Divestiture Assets until one year after such divestitures have been completed. X. Compliance Inspection A. For the purposes of determining or securing compliance with this Final Judgment or whether the Final Judgment should be modified or vacated, and subject to any legally recognized privilege, authorized representatives of the United States Department of Justice (including consultants and other persons retained by plaintiff United States) shall, upon written request of an authorized representative of the Assistant Attorney General in charge of the Antitrust Division, and on reasonable notice to defendants, be permitted:

(1)Access during defendants' office hours to inspect and copy, or at plaintiff United States's option, to require defendants to provide hard copy or electronic copies of, all books, ledgers, accounts, records, data and documents in the possession, custody, or control of defendants, relating to any matters contained in this Final Judgment; and

(2)To interview, either informally or on the record, defendants' officers, employees, or agents, who may have their individual counsel present, regarding such matters. The interviews shall be subject to the reasonable convenience of the interviewee and without restraint or interference by defendants. B. Upon the written request of an authorized representative of the Assistant Attorney General in charge of the Antitrust Division, defendants shall submit written reports or response to written interrogatories, under oath if requested, relating to any of the matters contained in this Final Judgment as may be requested. C. No information or documents obtained by the means provided in this section shall be divulged by plaintiff United States to any person other than an authorized representative of the executive branch of plaintiff United States or, pursuant to a customary protective order or waiver of confidentiality by defendants, the FCC, except in the course of legal proceedings to which plaintiff United States is a party (including grand jury proceedings), or for the purpose of securing compliance with this Final Judgment, or as otherwise required by law. D. If at the time information or documents are furnished by defendants to plaintiff United States, defendants represent and identify in writing the material in any such information or documents to which a claim of protection may be asserted under Rule 26(c)(l)(G) of the Federal Rules of Civil Procedure, and defendants mark each pertinent page of such material, “Subject to claim of protection under Rule 26(c)(l)(G) of the Federal Rules of Civil Procedure,” then plaintiff United States shall give defendants ten

(10)calendar days notice prior to divulging such material in any legal proceeding (other than a grand jury proceeding). XI. No Reacquisition Defendants may not reacquire or lease any part of the Divestiture Assets during the term of this Final Judgment. XII. Retention of Jurisdiction This Court retains jurisdiction to enable any party to this Final Judgment to apply to this Court at any time for further orders and directions as may be necessary or appropriate to carry out or construe this Final Judgment, to modify any of its provisions, to enforce compliance, and to punish violations of its provisions. XIII. Expiration of Final Judgment Unless this Court grants an extension, this Final Judgment shall expire ten years from the date of its entry. XIV. Public Interest Determination Entry of this Final Judgment is in the public interest. The parties have complied with the requirements of the Antitrust Procedures and Penalties Act, 15 U.S.C. 16, including making copies available to the public of this Final Judgment, the Competitive Impact Statement, and any comments thereon and plaintiff United States's responses to comments. Based upon the record before the Court, which includes the Competitive Impact Statement and any comments and response to comments filed with the Court, entry of this Final Judgment is in the public interest. Date: Court approval subject to procedures of Antitrust Procedures and Penalties Act, 15 U.S.C. 16. United States District Judge In the United States District Court for the District of Columbia *United States Of America and State Of Vermont, Plaintiffs,* v. *Verizon Communications Inc. and Rural Cellular Corporation, Defendants.* Case No. 1:08-cv-00993(EGS). Judge Emmet G. Sullivan. Filed: June 10, 2008. Competitive Impact Statement Plaintiff United States of America (“United States”), pursuant to Section 2(b) of the Antitrust Procedures and Penalties Act (“APPA” or “Tunney Act”), 15 U.S.C. 1 6(h)-(h), files this Competitive Impact Statement relating to the proposed Final Judgment submitted for entry in this civil antitrust proceeding. I. Nature and Purpose of the Proceeding Defendants entered into an Agreement and Plan of Merger dated July 29, 2007, pursuant to which Verizon Communications Inc. (“Verizon”) will acquire Rural Cellular Corporation (“RCC”). Plaintiffs United States and the State of Vermont filed a civil antitrust Complaint on June 10, 2008 seeking to enjoin the proposed acquisition. The Complaint alleges that the likely effect of this acquisition would be to lessen competition substantially for mobile wireless telecommunications services throughout Vermont, one geographic area in New York that is contiguous to Vermont, and in northeast Washington, in violation of Section 7 of the Clayton Act, 15 U.S.C. 18. This loss of competition would result in consumers facing higher prices, lower quality service and fewer choices of mobile wireless telecommunications services. At the same time the Complaint was filed, plaintiffs also filed a Preservation of Assets Stipulation and Order and proposed Final Judgment, which are designed to eliminate the anticompetitive effects of the acquisition. Under the proposed Final Judgment, which is explained more fully below, defendants are required to divest RCC's mobile wireless telecommunications services businesses and related assets throughout Vermont, one geographic area in New York that is contiguous to Vermont, and in northeast Washington (“Divestiture Assets”). Under the terms of the Preservation of Assets Order, defendants will take certain steps to ensure that during the pendency of the ordered divestiture:

(a)The Divestiture Assets are preserved and operated as competitively independent, economically viable and ongoing businesses;

(b)the Divestiture Assets are operated independently and without influence by defendants; and

(c)competition is maintained. Plaintiffs and defendants have stipulated that the proposed Final Judgment may be entered after compliance with the APPA. Entry of the proposed Final Judgment would terminate this action, except that the Court would retain jurisdiction to construe, modify, or enforce the provisions of the proposed Final Judgment and to punish violations thereof. Defendants have also stipulated that they will comply with the terms of the Preservation of Assets Stipulation and Order and the proposed Final Judgment from the date of signing of the Preservation of Assets Stipulation and Order, pending entry of the proposed Final Judgment by the Court and the required divestitures. Should the Court decline to enter the proposed Final Judgment, defendants have also committed to continue to abide by its requirements and those of the Preservation of Assets Stipulation and Order until the expiration of time for appeal. II. Description of the Events Giving Rise to the Alleged Violation A. The Defendants and the Proposed Transaction Verizon, with headquarters in New York, is a corporation organized and existing under the laws of the state of Delaware. Verizon is one of the world's largest providers of communications services. Verizon is the second largest mobile wireless telecommunications services provider in the United States as measured by subscribers, provides mobile wireless telecommunications services in 49 states, and serves in excess of 65 million subscribers. In 2007, Verizon earned mobile wireless telecommunications services revenues of approximately $43 billion. RCC, with headquarters in Alexandria, Minnesota, is a corporation organized and existing under the laws of the state of Minnesota. RCC is the 10th largest mobile wireless telecommunications services provider in the United States, as measured by subscribers and provides mobile wireless telecommunications services in 15 states. It has approximately 790,000 subscribers. In 2007, RCC earned approximately $635.3 million in revenues. Pursuant to an Agreement and Plan of Merger dated July 29, 2007, Verizon will acquire RCC for approximately $2.67 billion. If this transaction is consummated, Verizon and RCC combined would have approximately 66 million subscribers in the United States, with $44 billion in mobile wireless telecommunications services revenues. The proposed transaction, as initially agreed to by defendants, would lessen competition substantially for mobile wireless telecommunications services throughout Vermont, one geographic area in New York that is contiguous to Vermont, and in northeast Washington. This acquisition is the subject of the Complaint and proposed Final Judgment filed by plaintiffs. B. Mobile Wireless Telecommunications Services Industry Mobile wireless telecommunications services allow customers to make and receive telephone calls and obtain data services using radio transmissions without being confined to a small area during the call or data session, and without the need for unobstructed line-of-sight to the radio tower. Mobility is highly valued by customers, as demonstrated by the more than 255 million people in the United States who own mobile wireless telephones. In 2007, revenues from the sale of mobile wireless telecommunications services in the United States were over $138 billion. To meet this desire for mobility, mobile wireless telecommunications services providers must deploy extensive networks of switches and radio transmitters and receivers and interconnect their networks with the networks of wireline carriers and other mobile wireless telecommunications services providers. In the early to mid-1980s, the FCC issued two cellular licenses (A-block and B-block) in each Metropolitan Statistical Area (“MSA”) and Rural Service Area (“RSA”) (collectively, “Cellular Marketing Areas” or “CMAs”), with a total of 734 CMAs covering the entire United States. Each license consists of 25 MHz of spectrum in the 800 MHz band. The first mobile wireless voice systems using this cellular spectrum were based on analog technology, now referred to as first-generation or “1G” technology. In 1995, the FCC licensed additional spectrum for the provision of Personal Communications Services (“PCS”), a category of services that includes mobile wireless telecommunications services comparable to those offered by cellular licensees. These licenses are in the 1900 MHz band and are divided into six blocks: A, B, and C, which consist of 30 MHz each; and D, E, and F, which consist of 10 MHz each. Geographically, the A and B-block 30 MHz licenses are issued by Major Trading Areas (“MTAs”). C, D, E, and F-block licenses are issued by Basic Trading Areas (“BTAs”), several of which comprise each MTA. MTAs and BTAs do not generally correspond to MSAs and RSAs. With the introduction of the PCS licenses, both cellular and PCS licensees began offering digital services, thereby increasing network capacity, shrinking handsets, and extending battery life. In addition, in 1996, one provider, a specialized mobile radio (“SMR” or “dispatch”) spectrum licensee, began to use its SMR spectrum to offer mobile wireless telecommunications services comparable to those offered by other mobile wireless telecommunications services providers, in conjunction with its dispatch, or “push-to-talk,” service. Although there are a number of providers holding spectrum licenses in each area of the country, not all providers have fully built out their networks throughout each license area. In particular, because of the characteristics of PCS spectrum, providers holding this type of spectrum generally have found it less attractive to build out in rural areas. Today, more than 95 percent of the total U.S. population lives in counties where three or more mobile wireless telecommunications services operators offer service. Nearly all mobile wireless voice services have migrated to second-generation or “2G” digital technologies, GSM (global standard for mobility), and CDMA (code division multiple access). Even more advanced technologies (“2.5G” and “3G”), based on the earlier 2G technologies, have been deployed for mobile wireless data services. Additionally, during the past two years, the FCC has auctioned off additional spectrum that can be used to support mobile wireless telecommunications services, including Advanced Wireless Spectrum (1710-1755 MHz and 2110-2155 MHz bands) and 700 MHz band spectrum, although it will be several years before mobile wireless telecommunications services based on this spectrum are widely deployed. C. The Competitive Effects of the Transaction on Mobile Wireless Telecommunications Services Mobile wireless telecommunications services include both voice and data services provided over a radio network and allow customers to maintain their telephone calls or data sessions without wires when traveling. There are no cost-effective alternatives to mobile wireless telecommunications services. Because fixed wireless services are not mobile, they are not regarded by consumers of mobile wireless telecommunications services to be a reasonable substitute for those services. It is unlikely that a sufficient number of customers would switch away from mobile wireless telecommunications services to make a small but significant price increase in those services unprofitable. The United States comprises numerous local geographic markets for mobile wireless telecommunications services. 1 A large majority of customers use mobile wireless telecommunications services in close proximity to their workplaces and homes. Thus, customers purchasing mobile wireless telecommunications services choose among mobile wireless telecommunications services providers that offer services where they live, work, and travel on a regular basis. The geographic areas in which the FCC has licensed mobile wireless telecommunications services providers often represent the core of the business and social sphere within which customers have the same competitive choices for mobile wireless telephone services. The number and identity of mobile wireless telecommunications services providers vanes among geographic areas, as does the quality of services and breadth of geographic coverage offered by providers. Some mobile wireless telecommunications services providers can and do offer different promotions, discounts, calling plans, and equipment subsidies in different geographic areas, varying the price for customers by geographic area. 1 The existence of local markets does not, of course, preclude the possibility of competitive effects in a broader geographic area, such as a regional or national area. The relevant geographic markets, under Section 7 of the Clayton Act, 15 U.S.C. 18, where the transaction will substantially lessen competition for mobile wireless telecommunications services are effectively represented by the following FCC spectrum licensing areas: Burlington, Vermont (CMA 248); New York RSA-2 (CMA 560); Vermont RSA-l (CMA 679); Vermont RSA-2 (CMA 680); Washington RSA-2 (CMA 694); and Washington RSA-3 (CMA 695). It is unlikely that a sufficient number of customers would switch to mobile wireless telecommunications services providers who do not offer services in these geographic areas to make a small but significant price increase in the relevant geographic markets unprofitable. These geographic areas of concern for mobile wireless telecommunications services were identified via a fact-specific, market-by-market analysis that included consideration of, but was not limited to, the following factors: the number of mobile wireless telecommunications services providers and their competitive strengths and weaknesses; Verizon's and RCC's market shares, along with those of the other providers; whether additional spectrum is, or is likely soon to be, available; whether any providers are limited by insufficient spectrum or other factors in their ability to add new customers; the concentration of the market, and the breadth and depth of coverage by different providers in each area and in the surrounding area; and the likelihood that any provider would expand its existing coverage or that new providers would enter. In each of the cellular license areas described above, Verizon and RCC are the two largest carriers (based on subscribers), with a combined share in each area ranging from over 60% to nearly 94%, and are each other's closest competitor for a significant set of customers. In all but a portion of one of these cellular license areas, Verizon and RCC hold all of the cellular spectrum licenses. In a portion of the Vermont RSA 2 license area (consisting of Bennington and Windham counties, and the portion of Windsor County south of U.S. Route 4), Verizon does not own cellular spectrum, but it is a strong competitor because, unlike many other providers with PCS spectrum in rural areas, it has constructed a PCS network that covers a significant portion of the population, supplements that network with roaming on another carrier's cellular network and plans to substantially expand its own PCS network in the future. Thus, even in that area, Verizon and RCC are the leading two competitors in terms of share. Taking into account the factors that potentially impact competition including coverage area, brand recognition, service quality and reputation, handset selection, and service features, Verizon and RCC are stronger competitors, and thus closer substitutes for each other for a significant set of customers, than the other cellular provider, and the other PCS providers, that serve this area. The relevant geographic areas for mobile wireless services are also highly concentrated. As measured by the Herfindahl-Hirschman Index (“HHI”), which is commonly employed in merger analysis and is defined and explained in Appendix A to this Complaint, concentration in these areas ranges from over 2800 to more than 5100, which is well above the 1800 threshold at which plaintiffs consider a market to be highly concentrated. After Verizon's proposed acquisition of RCC is consummated, the HHIs in the relevant geographic areas will range from over 4900 to over 8700, with increases in the HHI as a result of the merger ranging from over 1200 to over 4200, significantly beyond the thresholds at which plaintiffs consider a transaction likely to cause competitive harm. Competition between Verizon and RCC in the relevant geographic areas has resulted in lower prices and higher quality in mobile wireless telecommunications services than would otherwise have existed in these geographic areas. If Verizon's proposed acquisition of RCC is consummated, the competition between Verizon and RCC in mobile wireless telecommunications services will be eliminated in these areas and the relevant geographic areas for mobile wireless telecommunications services will become substantially more concentrated. As a result, the loss of competition between Verizon and RCC increases the merged firm's incentive and ability in the relevant geographic markets to increase prices, diminish the quality or quantity of services provided, and refrain from or delay making investments in network improvements. Entry by a new mobile wireless services provider in the relevant geographic areas would be difficult, time-consuming, and expensive, requiring spectrum licenses and the build out of a network. Therefore, any entry in response to a small but significant price increase for mobile wireless telecommunications services by the merged firm in these relevant geographic areas would not be timely, likely, or sufficient to thwart the competitive harm resulting from Verizon's proposed acquisition of RCC, if it were to be consummated. For these reasons, plaintiffs concluded that Verizon's proposed acquisition of RCC will likely substantially lessen competition, in violation of Section 7 of the Clayton Act, in the provision of mobile wireless telecommunications services in the relevant geographic areas alleged in the Complaint. III. Explanation of the Proposed Final Judgment The divestiture requirements of the proposed Final Judgment will eliminate the anticompetitive effects of the acquisition in mobile wireless telecommunications services in the geographic areas of concern. The proposed Final Judgment requires defendants, within one hundred twenty

(120)days after the consummation of the Transaction, or five

(5)days after notice of the entry of the Final Judgment by the Court, whichever is later, to divest the Divestiture Assets. The Divestiture Assets are essentially RCC's entire mobile wireless telecommunications services businesses in the geographic areas described herein where Verizon and RCC are each other's closest competitors for mobile wireless telecommunications services. These assets must be divested in such a way as to satisfy plaintiff United States, (and with respect to the Divestiture Assets located in Vermont upon consultation with plaintiff Vermont), in its sole discretion that the assets will be operated by the purchaser as a viable, ongoing business that can compete effectively in each relevant area. Defendants must take all reasonable steps necessary to accomplish the divestitures quickly and shall cooperate with prospective purchasers. The proposed Final Judgment requires that a single purchaser acquire the Divestiture Assets in New York and Vermont, and a single purchaser acquire the Divestiture Assets in Washington. This will allow the purchaser of these assets to supply service to customers that require mobile wireless telecommunications services throughout each of these areas in the same way that RCC is currently able to provide that service. This provision resolves concerns about the loss of competition for customers that demand coverage over a combination of FCC licensing areas, in addition to the concerns due to eliminating competition within each licensing area. Under limited circumstances, defendants are permitted to retain specified portions of RCC's mobile wireless assets in the relevant geographic areas. First, plaintiffs are not requiring the divestiture of the PCS spectrum held by RCC in the RSAs being divested. In requiring the divestitures, plaintiffs seek to make certain that the potential buyer acquires all the assets it may need to be a viable competitor and replace the competition lost by the merger. The 25 MHz of cellular spectrum that must be divested is typically sufficient to support the operation and expansion of the mobile wireless telecommunications services businesses being divested, enabling the buyer to be a viable competitor to the merged entity. Similarly, defendants are not required to divest CDMA equipment on the Mt. Stratton, Vermont tower or the CDMA, TDMA, and analog equipment on the Woodstock, Vermont tower, although they will be required to divest the GSM equipment located on these towers. The CDMA, TDMA and analog equipment located on these towers is not part of the GSM network being divested and therefore is not essential to the operations of the divested business. The Acquirer will receive the GSM network assets it will need to operate effectively in this area. Third, defendant Verizon may retain defendant RCC's Colchester, Vermont switches (an Ericsson AXE 810 and a Lucent SE). Verizon needs the Ericsson switch to provide service to RCC's GSM customers Verizon is acquiring in Maine and New Hampshire, where Verizon currently has only a CDMA network. It also needs the Lucent switch to support CDMA, TDMA, and analog services used predominantly by roaming customers in Massachusetts, New Hampshire, New York, and Vermont. A potential acquirer of the Divestiture Assets, which include RCC's GSM network, will either already have, or will be able to quickly obtain, GSM switching capability and will not need TDMA or analog switching to support the divested business. Additionally, in two instances, defendants may seek approval to retain certain spectrum in Vermont. First, in the Burlington MSA, the merged firm wants to retain RCC's PCS spectrum to insure that it has sufficient spectrum to support its wireless telecommunications services. Depending on the identity of the Acquirer, it may not need this additional PCS spectrum to be an effective competitor. Once an Acquirer is presented for approval, plaintiff United States, in its sole discretion upon consultation with Vermont, will determine whether the proposed Acquirer needs the PCS spectrum to insure it can operate a competitive business with Divestiture Assets its receives and whether allowing defendants to keep the cellular spectrum is consistent with the purposes of the Final Judgment. Second, for the portion of Vermont RSA 2 where Verizon does not own the cellular license, defendants are concerned that they will be unable to promptly roll out wireless broadband services to the citizens of Vermont if they cannot retain any of RCC's cellular spectrum in this area. Once an Acquirer is identified, plaintiff United States, in its sole discretion upon consultation with Vermont, will determine whether Verizon should be allowed substitute 10 MHz of RCC's cellular spectrum for the 10 MHz of PCS spectrum it would otherwise retain. A. Timing of Divestitures In antitrust cases involving mergers or joint ventures in which the United States seeks a divestiture remedy, it requires completion of the divestitures within the shortest time period reasonable under the circumstances. Section IV.A.g of the proposed Final Judgment in this case requires divestiture of the Divestiture Assets, within one hundred twenty

(120)days after the consummation of the Transaction, or five

(5)days after notice of the entry of the Final Judgment by the Court, whichever is later. Plaintiff United States in its sole discretion, and with respect to the Divestiture Assets located in Vermont upon consultation with plaintiff Vermont, may extend the date for divestiture of the Divestiture Assets by up to sixty

(60)days. Because the FCC's approval is required for the transfer of the wireless licenses to a purchaser, Section IV.A provides that if applications for transfer of a wireless license have been filed with the FCC, but the FCC has not acted dispositively before the end of the required divestiture period, the period for divestiture of those assets shall be extended until five

(5)days after the FCC has acted. This extension is to be applied only to the individual Divestiture Assets affected by the delay in approval of the license transfer and does not entitle defendants to delay the divestiture of any other Divestiture Assets for which license transfer approval is not required or has been granted. The divestiture timing provisions of the proposed Final Judgment will ensure that the divestitures are carried out in a timely manner, and at the same time will permit defendants an adequate opportunity to accomplish the divestitures through a fair and orderly process. Even if all Divestiture Assets have not been divested upon consummation of the transaction, there should be no adverse impact on competition given the limited duration of the period of common ownership and the detailed requirements of the Preservation of Assets Stipulation and Order. B. Use of a Management Trustee The Preservation of Assets Stipulation and Order, filed simultaneously with this Competitive Impact Statement, ensures that, prior to divestiture, the Divestiture Assets remain an ongoing business concern. The Preservation of Assets Stipulation and Order is designed to ensure that the Divestiture Assets will be preserved and remain independent of defendants, so that competition is maintained during the pendency of the ordered divestiture. The Preservation of Assets Stipulation and Order provides for the appointment of a management trustee selected by plaintiff United States, and with respect to Divestiture Assets located in Vermont upon consultation with plaintiff Vermont, to oversee the Divestiture Assets. The appointment of a management trustee in this situation is required because the Divestiture Assets are not independent facilities that can be held separate and operated as stand-alone units by the merged firm. Rather, the Divestiture Assets are an integral part of a larger network and, to maintain their competitive viability and economic value, they should remain part of that network during the divestiture period. A management trustee will oversee the continuing relationship between defendants and these assets, to ensure that these assets are preserved and supported by defendants during this period, yet run independently. The management trustee will have the power to operate the Divestiture Assets in the ordinary course of business, so that they will remain independent and uninfluenced by defendants, and so that the Divestiture Assets are preserved and operated as an ongoing and economically viable competitor to defendants and to other mobile wireless telecommunications services providers. The management trustee will preserve the confidentiality of competitively sensitive marketing, pricing, and sales information; ensure defendants' compliance with the Preservation of Assets Stipulation and Order and the proposed Final Judgment; and maximize the value of the Divestiture Assets so as to permit expeditious divestiture in a manner consistent with the proposed Final Judgment. The Preservation of Assets Stipulation and Order provides that defendants will pay all costs and expenses of the management trustee, including the cost of consultants, accountants, attorneys, and other representatives and assistants hired by the management trustee as are reasonably necessary to carry out his or her duties and responsibilities. After his or her appointment becomes effective, the management trustee will file monthly reports with plaintiffs setting forth efforts taken to accomplish the goals of the Preservation of Assets Stipulation and Order and the proposed Final Judgment and the extent to which defendants are fulfilling their responsibilities. Finally, the management trustee may become the divestiture trustee, pursuant to the provisions of Section V of the proposed Final Judgment. C. Use of a Divestiture Trustee In the event that defendants do not accomplish the divestiture within the periods prescribed in the proposed Final Judgment, the Final Judgment provides that the Court will appoint a trustee selected by plaintiff United States, and with respect to Divestiture Assets located in Vermont upon consultation with plaintiff Vermont, to effect the divestitures. As part of this divestiture, defendants must relinquish any direct or indirect financial ownership interests and any direct or indirect role in management or participation in control. Pursuant to Section V of the proposed Final Judgment, the divestiture trustee will own and control the Divestiture Assets until they are sold to a final purchaser, subject to safeguards to prevent defendants from influencing their operation. Section V details the requirements for the establishment of the divestiture trust, the selection and compensation of the divestiture trustee, the responsibilities of the divestiture trustee in connection with the divestiture and operation of the Divestiture Assets, and the termination of the divestiture trust. The divestiture trustee will have the obligation and the sole responsibility, under Section V.D, for the divestiture of any transferred Divestiture Assets. The divestiture trustee has the authority to accomplish divestitures at the earliest possible time and “at such price and on such terms as are then obtainable upon reasonable effort by the Divestiture Trustee.” In addition, to ensure that the divestiture trustee can promptly locate and divest to an acceptable purchaser, United States, in its sole discretion, and with respect to Divestiture Assets located in Vermont upon consultation with plaintiff Vermont, may require defendants to include additional assets, or allow defendants to substitute substantially similar assets, which substantially relate to the Divestiture Assets to be divested by the divestiture trustee. The divestiture trustee will not only have responsibility for sale of the Divestiture Assets, but will also be the authorized holder of the wireless licenses, with full responsibility for the operations, marketing, and sales of the wireless businesses to be divested, and will not be subject to any control or direction by defendants. Defendants will no longer have any role in the ownership, operation, or management of the Divestiture Assets other than the right to receive the proceeds of the sale. Defendants will also retain certain obligations to support to the Divestiture Assets and cooperate with the divestiture trustee in order to complete the divestiture. The proposed Final Judgment provides that defendants will pay all costs and expenses of the divestiture trustee. The divestiture trustee's commission will be structured, under Section V.G of the proposed Final Judgment, so as to provide an incentive for the divestiture trustee based on the price obtained and the speed with which the divestitures are accomplished. After his or her appointment becomes effective, the divestiture trustee will file monthly reports with the Court and plaintiffs setting forth his or her efforts to accomplish the divestitures. Section V.J requires the divestiture trustee to divest the Divestiture Assets to an acceptable purchaser or purchasers no later than six

(6)months after the assets are transferred to the divestiture trustee. At the end of six

(6)months, if all divestitures have not been accomplished, the trustee and plaintiffs will make recommendations to the Court, which shall enter such orders as appropriate in order to carry out the purpose of the Final Judgment, including extending the trust or term of the trustee's appointment. The divestiture provisions of the proposed Final Judgment will eliminate the anticompetitive effects of the transaction in the provision of mobile wireless telecommunications services. The divestitures of the Divestiture Assets will preserve competition in mobile wireless telecommunications services by maintaining an independent and economically viable competitor in the relevant geographic areas. IV. Remedies Available to Potential Private Litigants Section 4 of the Clayton Act, 15 U.S.C. 15, provides that any person who has been injured as a result of conduct prohibited by the antitrust laws may bring suit in federal court to recover three times the damages the person has suffered, as well as costs and reasonable attorneys' fees. Entry of the proposed Final Judgment will neither impair nor assist the bringing of any private antitrust damage action. Under the provisions of Section 5(a) of the Clayton Act, 15 U.S.C. 16(a), the proposed Final Judgment has no prima facie effect in any subsequent private lawsuit that may be brought against defendants. V. Procedures Available for Modification of the Proposed Final Judgment The United States and defendants have stipulated that the proposed Final Judgment may be entered by the Court after compliance with the provisions of the APPA, provided that the United States has not withdrawn its consent. The APPA conditions entry upon the Court's determination that the proposed Final Judgment is in the public interest. The APPA provides a period of at least sixty

(60)days preceding the effective date of the proposed Final Judgment within which any person may submit to the United States written comments regarding the proposed Final Judgment. Any person who wishes to comment should do so within sixty

(60)days of the date of publication of this Competitive Impact Statement in the **Federal Register** or the last date of publication in a newspaper of the summary of this Competitive Impact Statement, which ever is later. All comments received during this period will be considered by the Department of Justice, which remains free to withdraw its consent to the proposed Final Judgment at any time prior to the Court's entry of judgment. The comments and the response of plaintiff United States will be filed with the Court and published in the **Federal Register** . Written comments should be submitted to: Nancy M. Goodman, Chief, Telecommunications and Media Enforcement Section, Antitrust Division, U.S. Department of Justice, 1401 H Street, NW., Suite 8000, Washington, DC 20530. The proposed Final Judgment provides that the Court retains jurisdiction over this action, and the parties may apply to the Court for any order necessary or appropriate for the modification, interpretation, or enforcement of the Final Judgment. VI. Alternatives to the Proposed Final Judgment Plaintiffs considered, as an alternative to the proposed Final Judgment, a full trial on the merits against defendants. Plaintiffs could have continued the litigation and sought preliminary and permanent injunctions against Verizon's acquisition of RCC. Plaintiffs are satisfied, however, that the divestiture of assets and other relief described in the proposed Final Judgment will preserve competition for the provision of mobile wireless telecommunications services in the relevant areas identified in the Complaint. VII. Standard of Review Under the APPA for the Proposed Final Judgment The Clayton Act, as amended by the APPA, requires that proposed consent judgments in antitrust cases brought by the United States be subject to a sixty-day comment period, after which the Court shall determine whether entry of the proposed Final Judgment “is in the public interest.” 15 U.S.C. 16(e)(1). In making that determination, the court, in accordance with the statute as amended in 2004, is required to consider: A. The competitive impact of such judgment, including termination of alleged violations, provisions for enforcement and modification, duration of relief sought, anticipated effects of alternative remedies actually considered, whether its terms are ambiguous, and any other competitive considerations bearing upon the adequacy of such judgment that the court deems necessary to a determination of whether the consent judgment is in the public interest; and B. The impact of entry of such judgment upon competition in the relevant market or markets, upon the public generally and individuals alleging specific injury from the violations set forth in the complaint including consideration of the public benefit, if any, to be derived from a determination of the issues at trial. 15 U.S.C. 16(e)(1)(A) & (B). In considering these statutory factors, the court's inquiry is necessarily a limited one as the government is entitled to “broad discretion to settle with the defendant within the reach of the public interest.” *United States* v. *Microsoft Corp,* 56 F.3d 1448, 1461 (DC. Cir. 1995); *see generally United States* v. *SBC Commc'ns, Inc.,* 489 F. Supp. 2d 1, 11 (D.D.C. 2007) (assessing the public interest standard under the Tunney Act). 2 2 The 2004 amendments substituted “shall” for “may” in directing relevant factors for a court to consider and amended the list of factors to focus on competitive considerations and to address potentially ambiguous judgment terms. Compare 15 U.S.C. § 16(e) (2004), with 15 U.S.C. § 16(e)(1) (2006); see also SBC Commc'ns, 489 F. Supp. 2d at 11 (concluding that the 2004 amendments “effected minimal changes” to Tunney Act review). As the United States Court of Appeals for the District of Columbia Circuit has held, under the APPA a court considers, among other things, the relationship between the remedy secured and the specific allegations set forth in the government's complaint, whether the decree is sufficiently clear, whether enforcement mechanisms are sufficient, and whether the decree may positively harm third parties. *See Microsoft,* 56 F.3d at 1458-62. With respect to the adequacy of the relief secured by the decree, a court may not “engage in an unrestricted evaluation of what relief would best serve the public.” *United States* v. *BNS, Inc.,* 858 F.2d 456, 462 (9th Cir. 1988) (citing *United States* v. *Bechtel Corp.,* 648 F.2d 660, 666 (9th Cir. 1981)); *see also Microsoft,* 56 F.3d at 1460-62; *United States* v *Alcoa, Inc.,* 152 F. Supp. 2d 37, 40 (D.D.C. 2001). Courts have held that: [t]he balancing of competing social and political interests affected by a proposed antitrust consent decree must be left, in the first instance, to the discretion of the Attorney General. The court's role in protecting the public interest is one of insuring that the government has not breached its duty to the public in consenting to the decree. The court is required to determine not whether a particular decree is the one that will best serve society, but whether the settlement is “ *within the reaches of the public interest* .” More elaborate requirements might undermine the effectiveness of antitrust enforcement by consent decree. *Bechtel,* 648 F.2d at 666 (emphasis added) (citations omitted). 3 In determining whether a proposed settlement is in the public interest, a district court “must accord deference to the government's predictions about the efficacy of its remedies, and may not require that the remedies perfectly match the alleged violations.” SBC *Commc'ns,* 489 F. Supp. 2d at 17; *see also Microsoft,* 56 F.3d at 1461 (noting the need for courts to be “deferential to the government's predictions as to the effect of the proposed remedies”); *United States* v. *Archer-Daniels-Midland Co.,* 272 F. Supp. 2d 1, 6 (D.D.C. 2003) (noting that the court should grant due respect to the United States' prediction as to the effect of proposed remedies, its perception of the market structure, and its views of the nature of the case). 3 *Cf BNS,* 858 F.2d at 464 (holding that the court's “ultimate authority under the [APPA] is limited to approving or disapproving the consent decree”); *United States* v. *Gillette Co.,* 406 F. Supp. 713, 716 (D. Mass. 1975) (noting that, in this way, the court is constrained to “look at the overall picture not hypercritically, nor with a microscope, but with an artist's reducing glass”). *See generally Microsoft,* 56 F.3d at 1461 (discussing whether “the remedies [obtained in the decree are] so inconsonant with the allegations charged as to fall outside of the `reaches of the public interest' ”). Courts have great flexibility in approving proposed consent decrees than in crafting their own decrees following a finding of liability in a litigated matter. “[A] proposed decree must be approved even if it falls short of the remedy the court would impose on its own, as long as it falls within the range of acceptability or is `within the reaches of public interest.' ” *United States* v. *Am. Tel. & Tel. Co.,* 552 F. Supp. 131, 151 (D.D.C. 1982) (citations omitted) (quoting *United States* v. *Gillette Co.,* 406 F. Supp. 713, 716 (D. Mass. 1975)), *affdsub nom. Maryland* v. *United States,* 460 U.S. 1001 (1983); see also *United States* v. *Alcan Aluminum Ltd.,* 605 F. Supp. 619, 622 (W.D. Ky. 1985) (approving the consent decree even though the court would have imposed a greater remedy). To meet this standard, the United States “need only provide a factual basis for concluding that the settlements are reasonably adequate remedies for the alleged harms.” *SBC Commc'ns,* 489 F. Supp. 2d at 17. Moreover, the Court's role under the APPA is limited to reviewing the remedy in relationship to the violations that the United States has alleged in its Complaint, and does not authorize the Court to “construct [its] own hypothetical case and then evaluate the decree against that case.” *Microsoft,* 56 F.3d at 1459. Because the “court's authority to review the decree depends entirely on the government's exercising its prosecutorial discretion by bringing a case in the first place,” it follows that “the court is only authorized to review the decree itself,” and not to “effectively redraft the complaint” to inquire into other matters that the United States did not pursue. *Id.* at 1459-60. As this Court recently confirmed in *SBC Communications,* courts “cannot look beyond the complaint in making the public interest determination unless the complaint is drafted so narrowly as to make a mockery of judicial power.” *SBC Commc'ns,* 489 F. Supp. 2d at 15. In its 2004 amendments, Congress made clear its intent to preserve the practical benefits of utilizing consent decrees in antitrust enforcement, adding the unambiguous instruction “[n]othing in this section shall be construed to require the court to conduct an evidentiary hearing or to require the court to permit anyone to intervene.” 15 U.S.C. 16(e)(2). The language wrote into the statute what the Congress that enacted the Tunney Act in 1974 intended, as Senator Tunney then explained: “[t]he court is nowhere compelled to go to trial or to engage in extended proceedings which might have the effect of vitiating the benefits of prompt and less costly settlement through the consent decree process.” 119 Cong. Rec. 24,598

(1973)(statement of Senator Tunney). Rather, the procedure for the public interest determination is left to the discretion of the court, with the recognition that the court's “scope of review remains sharply proscribed by precedent and the nature of Tunney Act proceedings.” *SBC Commc'ns* , 489 F. Supp. 2d at 11. 4 4 *See United States* v. *Enova Corp.,* 107 F. Supp. 2d 10, 17 (D.D.C. 2000) (noting that the “Tunney Act expressly allows the court to make its public interest determination on the basis of the competitive impact statement and response to comments alone”); *United States* v. *Mid-Am. Dairymen, Inc.,* 1977-1 Trade Cas.

(CCH)11 61,508, at 71,980 (W.D. Mo. 1977) (“Absent a showing of corrupt failure of the government to discharge its duty, the Court, in making its public interest finding, should * * * carefully consider the explanations of the government in the competitive impact statement and its responses to comments in order to determine whether those explanations are reasonable under the circumstances.”); S. Rep. No. 93-298, 93d Cong., 1st Sess., at 6

(1973)(”Where the public interest can be meaningfully evaluated simply on the basis of briefs and oral arguments, that is the approach that should be utilized.”). VIII. Determinative Documents There are no determinative materials or documents within the meaning of the APPA that were considered by plaintiff United States in formulating the proposed Final Judgment. Dated: June 10, 2008. Respectfully submitted, Hillary B. Burchuk (DC Bar No. 366755), Lawrence M. Frankel (DC Bar No. 441532), Jared A. Hughes, Deborah Roy (DC Bar No. 452573), *Attorneys, Telecommunications & Media Enforcement Section, Antitrust Division, U.S. Department of Justice, City Center Building, 1401 H Street, NW., Suite 8000, Washington, DC 20530,

(202)514-5621, Facsimile:

(202)514-6381* . [FR Doc. E8-14545 Filed 6-26-08; 8:45 am] BILLING CODE 4410-11-M DEPARTMENT OF JUSTICE Antitrust Division Notice Pursuant to the National Cooperative Research and Production Act of 1993—Open Mobile Alliance Notice is hereby given that, on April 25, 2008, pursuant to Section 6(a) of the National Cooperative Research and Production Act of 1993, 15 U.S.C. 4301 *et seq.* (“the Act”), the Open Mobile Alliance (“OMA”) filed written notifications simultaneously with the Attorney General and the Federal Trade Commission disclosing changes in its membership. The notifications were filed for the purpose of extending the Act's provisions limiting the recovery of antitrust plaintiffs to actual damages under specified circumstances. Specifically, Adaptive Mobile Security Ltd., Dublin, IRELAND; Adobe Systems Incorporated, San Francisco, CA; AltGen Co., Ltd., Mapo-Gu, Seoul, REPUBLIC OF KOREA; Amobee, Herzlia, ISRAEL; Axel Technologies, Turku, FINLAND; Best of the Web, Uniondale, NY; Cable Television Laboratories, Inc., Louisville, CO; Cambridge Silicon Radio plc, Cambridge, UNITED KINGDOM; castLabs GmbH, Berlin, GERMANY; Cell Guide, Rehorot, ISRAEL; Cisco Systems, Milpitas, CA; Cloudmark, Inc., San Francisco, CA; Communigate Systems, Mill Valley, CA; Connectivity Communications Limited, London, UNITED KINGDOM; decontis GmbH, Loebau, GERMANY; Digicert SSL Certificate Authority, Lindon, UT; DKI Technology Inc., Young deungpo-gu, Seoul, REPUBLIC OF KOREA; Dynamic Motion Technologies, Ipoh, Perak, MALAYSIA; Eluon Corporation, Seocho-Gu, Seoul, REPUBLIC OF KOREA; EnSoft Co., Ltd., Guro-gu, Seoul, REPUBLIC OF KOREA; Entosys Co., Ltd., Mapo-Gu, Seoul, REPUBLIC OF KOREA; Gemalto N.V., Amsterdam, THE NETHERLANDS; GoldSpot Media Inc., Sunnyvale, CA; Hand Cell Phone, Chattanooga, TN; Handmark, Inc.; Kansas City, MO; Hellosoft, Inc., Andhoa Pradesh, INDIA; INKA Entworks, Inc., Kangnam-Gu, Seoul, REPUBLIC OF KOREA; Intertrust Technologies Corporation, Sunnyvale, CA; INTICUBE Corp., Jung-gu, Seoul, REPUBLIC OF KOREA; Intrinsyc Software International, Inc., Bellevue, WA; I-ON Communications Co., Ltd., Gangnam-gu, Seoul, REPUBLIC OF KOREA; Kimia Solutions S.L., Madrid, SPAIN; Motive Inc., Austin, TX; Mtag, Paris, FRANCE; Nable Communications, Inc., Kangnam-Gu, Seoul, REPUBLIC OF KOREA; NeoMedia Technologies, Inc., Atlanta, GA; Nokia Siemens Networks, Munich, GERMANY; NOW Wireless Ltd., Croydon, UNITED KINGDOM; NTT Advanced Technology Corporation, Tokyo, JAPAN; NTT Multimedia Communications Laboratories, Inc., San Mateo, CA; Palm, Inc., Sunnyvale, CA; Payzy Corp., Koongtoey, Bangkok, THAILAND; Point-I Co., Ltd., Gangnam-Gu, Seoul, REPUBLIC OF KOREA; Porss Technology Co., Ltd., Xicheng District, Beijing, PEOPLE'S REPUBLIC OF CHINA; RealNetworks, Inc., Seattle, WA; RRD Reti Radiotelevisive Digitali, S.p.A, Milan, ITALY; RSystems Inc., El Dorado Hills, CA; Rx Networks, Vancouver, BC, CANADA; Scanbuy, Inc., New York, NY; Silicon & Software Systems Limited, Leopardstown, Dublin, IRELAND; Sintesio Foundation, Bled, SLOVENIA; Softbank Mobile Corp., Minato-ku, Tokyo, JAPAN; Solaiemes, Madrid, SPAIN; Sunplus mMobile, Hsinchu Science Park, TAIWAN; Syniverse Technologies, Inc., Tampa, FL; Telcordia, Piscataway, NJ; Telcoware Co., Ltd., Seocho-Gu, Seoul, REPUBLIC OF KOREA; Telogic Sdn. Bhd., Petaling Jaya, Selangor, MALAYSIA; Thin Multimedia, Inc., Seocho-Ku, Seoul, REPUBLIC OF KOREA; THOMSON, Cesson-Sevigne, FRANCE; TruePosition, Inc., Berwyn, PA; Ulticom Incorporated, Mt. Laurel, NJ; V4X SAS, Bordeaux Pessac, FRANCE; Vidiator, Bellevue, WA; Vishwak Solutions Pvt. Ltd., Chennai, INDIA; Webmessenger Inc., Tujunga, CA; weComm Limited, London, UNITED KINGDOM; Welgate Corp., Seocho Dong, Seoul, REPUBLIC OF KOREA; WRG, Inc., Seongnam-Si, Gyeonggi-Do, REPUBLIC OF KOREA; and Yahoo, Inc., Sunnyvale, CA, have been added as parties to this venture. Also, Ad Vitam, Olivet, FRANCE; Adamind, Ra'anana, ISRAEL; Advanced Strategies Corp., Garden City, NY; ATIO Corporation, Coombe Place, Rivonia, REPUBLIC OF SOUTH AFRICA; BenQ Mobile, Munich, GERMANY; Bitfone Corporation, Laguna Niguel, CA; Bytemobile, Inc., Mountain View, CA; CA Inc., Islandia, NY; Ceno Technologies, Ltd., Shanghai, PEOPLE'S REPUBLIC OF CHINA; Consistec Engineering & Consulting, Saarbrucken, GERMANY; Contec Innovations Inc., Port Coquitlam, BC, CANADA; Dai Nippon Printing Co. Ltd., Toshima-ku, Tokyo, JAPAN; DxO Labs, Boulogne, FRANCE; Edge Technologies, Inc., Fairfax, VA; Elcoteq SE, Salo, FINLAND; Emirates Telecommunications Corporation, Abu Dhabi, UNITED ARAB EMIRATES; Estacado Systems, LLC, Dallas, TX; Faith, Inc., Kyoto, JAPAN; Fastmobile Inc., Rolling Meadows, IL; Finnet-liitto ry, Helsinki, FINLAND; Firsthop, Helsinki, FINLAND; Fraunhofer Institut, Ilmenau, GERMANY; Freescale Semiconductor Inc., Austin, TX; gate5 AG, Berlin, GERMANY; Global Locate, San Jose, CA; GloNav, Inc., Newport Beach, CA; Huone Inc., Daegu, REPUBLIC OF KOREA; IC3S Information, Computer Solartechnik AG, Quickborn, GERMANY; I'M Technologies Ltd., The Signature, SINGAPORE; Incony AG, Paderborn, GERMANY; INNVO Systems, SINGAPORE; Insignia Solutions, Fremont, CA; Institute for Information Industry, Taipei, TAIWAN; Integration Services & Technologies Pty Ltd., Downer, ACT, AUSTRALIA; Inventec Appliances (Jiangning) Corporation, Nanjing, PEOPLE'S REPUBLIC OF CHINA; Leadtone Wireless Ltd., Chaoyang District, Beijing, PEOPLE'S REPUBLIC OF CHINA; Linkuall-Alcomia, Bordeaux, FRANCE; McAfee, Inc., Santa Clara, CA; Microelectronica Espanola, Madrid, SPAIN; Micromethod Technologies, Inc., San Jose, CA; Miyowa, Marseille, FRANCE; Mobile Cohesion, Belfast, UNITED KINGDOM; Mobilitec, Inc., San Mateo, CA; MStar Semiconductor, Inc., Hsinchu Hsien, TAIWAN; NDS Israel, Jerusalem, ISRAEL; Netxcalibur SRL, Florence, ITALY; Norbelle, LLC, Rancho Palos Verdes, CA; NTT Advanced Technology Corp. (OLD), Musashino-shi, Tokyo, JAPAN; NTT Software Corporation, Mitaka-shi, Tokyo, JAPAN; 02, Slough, UNITED KINGDOM; ObexCode AS, Oslo, NORWAY; OSS Nokalva Inc., Somerset, NJ; Prodyne Technologies Inc., St. Catharines, Ontario, CANADA; Quanta Computer Inc., Tao Yuan Shien, TAIWAN; Renesas Technology Corp., Chiyoda-ku, Tokyo, JAPAN; Sasken Communication Technologies Limited, Bangalore, INDIA; Savaje Technologies, Chelmsford, MA; Smart Internet Technology, Eveleigh, NSW, AUSTRALIA; Smartfone Limited, Hong Kong, HONG KONG-CHINA; Sonus Networks, Inc., Chelmsford, MA; Square Enix, Inc., El Segundo, CA; TechnoCom Corporation, Carlsbad, CA; Teleca Sweden AB, Lund, SWEDEN; Telefonica Moviles, Madrid, SPAIN; TeleworX Group, Inc., McLean, VA; Telus Mobility, Scarborough, Ontario, CANADA; Texas Instruments, Incorporated, Dallas, TX; UK Department of Trade and Industry, London, UNITED KINGDOM; Verisign, Inc., Mountain View, CA; VIDA Software, S.L., Barcelona, SPAIN; Visa International Services Association, Foster City, CA; Vodafone IT Hizmetleri A.S., Istanbul, TURKEY; WiderThan, Seoul, REPUBLIC OF KOREA; and Wireless Technologies Oy, Espoo, FINLAND, have withdrawn as parties to this venture. In addition, the following members have changed their names: LogicaCMG to Acision; Appium AB to AePona Ltd.; Alcatel to Alcatel-Lucent; Flextronics Software Systems to Aricent; Cingular Wireless to AT&T; IntroMobile Co., Ltd. to Insprit; Nortel Networks to Nortel; Telenor Mobil to Telenor ASA. No other changes have been made in either the membership or planned activity of the group research project. Membership in this group research project remains open, and OMA intends to file additional written notifications disclosing all changes in membership. On March 18, 1998, OMA filed its original notification pursuant to Section 6(a) of the Act. The Department of Justice published a notice in the **Federal Register** pursuant to Section 6(b) of the Act on December 31, 1998 (63 FR 72333). The last notification was filed with the Department on January 18, 2007. A notice was published in the **Federal Register** pursuant to Section 6(b) of the Act on February 26, 2007 (72 FR 8401). J. Robert Kramer, II, Director of Operations, Antitrust Division. [FR Doc. E8-14596 Filed 6-26-08; 8:45 am] BILLING CODE 4410-11-M DEPARTMENT OF JUSTICE Antitrust Division Notice Pursuant to the National Cooperative Research and Production Act of 1993—International SAE Consortium Ltd. (Formerly Known as SAE Consortium Ltd.) Notice is hereby given that, on May 21, 2008, pursuant to section 6(a) of the National Cooperative Research and Production Act of 1993, 15 U.S.C. 4301 *et seq.* (“the Act”), International SAE Consortium Ltd. (“ISAEC”) has filed written notifications simultaneously with the Attorney General and the Federal Trade Commission disclosing changes in its membership. The notifications were filed for the purpose of extending the Act's provisions limiting the recovery of antitrust plaintiffs to actual damages under specified circumstances. Specifically, Daiichi Sankyo, Inc., Edison, NJ; Takeda Global Research and Development Center, Inc., Deerfield, IL; and The Wellcome Trust, London, UNITED KINGDOM have been added as a party to this venture. No other changes have been made in either the membership or planned activity of the group research project. Membership in this group research project remains open, and ISAEC intends to file additional written notification disclosing all changes in membership. On September 27, 2007, ISAEC filed its original notification pursuant to Section 6(a) of the Act. The Department of Justice published a notice in the **Federal Register** pursuant to section 6(b) of the Act on November 7, 2007 (72 FR 62867). The last notification was filed with the Department of Justice on January 25, 2008. A notice was published in the **Federal Register** pursuant to section 6(b) of the Act on March 4, 2008 (73 FR 11680). J. Robert Kramer, II, Director of Operations, Antitrust Division. [FR Doc. E8-14597 Filed 6-26-08; 8:45 am] BILLING CODE 4410-11-M DEPARTMENT OF JUSTICE Antitrust Division Notice Pursuant to the National Cooperative Research and Production Act of 1993—Testing of Methods for Measuring Hydrocarbon Dew Points in Natural Gas Streams Notice is hereby given that, on May 13, 2008, pursuant to section 6(a) of the National Cooperative Research and Production Act of 1993, 15 U.S.C. 4301 et seq. (“the Act”), SwRI: Testing of Methods for Measuring Hydrocarbon Dew Points in Natural Gas Streams has filed written notifications simultaneously with the Attorney General and the Federal Trade Commission disclosing changes in its nature and objective. The notifications were filed for the purpose of extending the Act's provisions limiting the recovery of antitrust plaintiffs to actual damages under specified circumstances. Specifically, the period of performance has been extended to July 31, 2008. No other changes have been made in either the membership or planned activity of the group research project. Membership in this group research project remains open, and SwRI intends to file additional written notifications disclosing all changes in membership. On March 20, 2007, SwRI: Testing of Methods for Measuring Hydrocarbon Dew Points in Natural Gas Streams filed its original notification pursuant to section 6(a) of the Act. The Department of Justice published a notice in the **Federal Register** pursuant to section 6(b) of the Act on April 16, 2007 (72 FR 19023). The last notification was filed with the Department on October 30, 2007. A notice was published in the **Federal Register** pursuant to section 6(b) of the Act on December 20, 2007 (72 FR 72389). J. Robert Kramer, II, Director of Operations, Antitrust Division. [FR Doc. E8-14598 Filed 6-26-08; 8:45 am] BILLING CODE 4410-11-M DEPARTMENT OF JUSTICE Drug Enforcement Administration Importer of Controlled Substances; Notice of Application Pursuant to 21 U.S.C. 958(i), the Attorney General shall, prior to issuing a registration under this Section to a bulk manufacturer of a controlled substance in schedule I or II, and prior to issuing a registration under 21 U.S.C. 952(a)(2) authorizing the importation of such substances, provide manufacturers holding registrations for the bulk manufacture of the substance an opportunity for a hearing. Therefore, in accordance with 21 CFR 1301.34(a), this is notice that on May 13, 2008, Aptuit (Allendale) Inc., 75 Commerce Drive, Allendale, New Jersey 07401, made application by renewal to the Drug Enforcement Administration

(DEA)for registration as an importer of Noroxymorphone (9668), a basic class of controlled substance listed in schedule II. The company plans to import the basic class of controlled substance for clinical trials and research. Any manufacturer who presently, or is applying to be, registered with DEA to manufacture such basic class of controlled substance may file comments or objections to the issuance of the proposed registration and may, at the same time, file a written request for a hearing on such application pursuant to 21 CFR 1301.43 and in such form as prescribed by 21 CFR 1316.47. Any such written comments or objections being sent via regular mail should be addressed, in quintuplicate, to the Drug Enforcement Administration, Office of Diversion Control, Federal Register Representative (ODL), Washington, DC 20537, or any being sent via express mail should be sent to Drug Enforcement Administration, Office of Diversion Control, Federal Register Representative (ODL), 8701 Morrissette Drive, Springfield, Virginia 22152; and must be filed no later than July 28, 2008. This procedure is to be conducted simultaneously with, and independent of, the procedures described in 21 CFR 1301.34(b), (c), (d), (e), and (f). As noted in a previous notice published in the **Federal Register** on September 23, 1975, (40 FR 43745-46), all applicants for registration to import a basic class of any controlled substance listed in schedule I or II are, and will continue to be, required to demonstrate to the Deputy Assistant Administrator, Office of Diversion Control, Drug Enforcement Administration, that the requirements for such registration pursuant to 21 U.S.C. 958(a), 21 U.S.C. 823(a), and 21 CFR 1301.34(b), (c), (d), (e), and

(f)are satisfied. Dated: June 19, 2008. Joseph T. Rannazzisi, Deputy Assistant Administrator, Office of Diversion Control, Drug Enforcement Administration. [FR Doc. E8-14586 Filed 6-26-08; 8:45 am] BILLING CODE 4410-09-P DEPARTMENT OF JUSTICE Drug Enforcement Administration Importer of Controlled Substances Notice of Application Pursuant to 21 U.S.C. 958(i), the Attorney General shall, prior to issuing a registration under this Section to a bulk manufacturer of a controlled substance in schedule I or II, and prior to issuing a registration under 21 U.S.C. 952(a)(2) authorizing the importation of such a substance, provide manufacturers holding registrations for the bulk manufacture of the substance an opportunity for a hearing. Therefore, in accordance with Title 21 Code of Federal Regulations (CFR), 1301.34(a), this is notice that on May 8, 2008, Aptuit, 10245 Hickman Mills Drive, Kansas City, Missouri 64137, made application by renewal to the Drug Enforcement Administration

(DEA)to be registered as an importer of Marihuana (7360), a basic class of controlled substance listed in schedule I. The company plans to import a finished pharmaceutical product containing cannabis extracts in dosage form for packaging for a clinical trial study. Any bulk manufacturer who is presently, or is applying to be, registered with DEA to manufacture such basic class of controlled substance may file comments or objections to the issuance of the proposed registration and may, at the same time, file a written request for a hearing on such application pursuant to 21 CFR 1301.43 and in such form as prescribed by 21 CFR 1316.47. Any such comments or objections being sent via regular mail should be addressed, in quintuplicate, to the Drug Enforcement Administration, Office of Diversion Control, **Federal Register** Representative (ODL), Washington, DC 20537, or any being sent via express mail should be sent to Drug Enforcement Administration, Office of Diversion Control, **Federal Register** Representative (ODL), 8701 Morrissette Drive, Springfield, VA 22152; and must be filed no later than July 28, 2008. This procedure is to be conducted simultaneously with, and independent of, the procedures described in 21 CFR 1301.34(b), (c), (d), (e), and (f). As noted in a previous notice published in the **Federal Register** on September 23, 1975, (40 FR 43745-46), all applicants for registration to import a basic class of any controlled substance in schedule I or II are, and will continue to be, required to demonstrate to the Deputy Assistant Administrator, Office of Diversion Control, Drug Enforcement Administration, that the requirements for such registration pursuant to 21 U.S.C. 958(a); 21 U.S.C. 823(a); and 21 CFR 1301.34(b), (c), (d), (e), and

(DEA)to be registered as an importer of the basic classes of controlled substances listed in schedule II: Drug Schedule Coca Leaves

(9040)II Opium, raw

(9600)II Poppy Straw

(9650)II Concentrate of Poppy Straw

(9670)II The company plans to import the listed controlled substances to manufacture bulk controlled substance intermediates for sale to its customers. No comments or objections have been received. DEA has considered the factors in 21 U.S.C. 823(a) and 952(a) and determined that the registration of Penick Corporation to import the basic classes of controlled substances is consistent with the public interest and with United States obligations under international treaties, conventions, or protocols in effect on May 1, 1971, at this time. DEA has investigated Penick Corporation to ensure that the company's registration is consistent with the public interest. The investigation has included inspection and testing of the company's physical security systems, verification of the company's compliance with state and local laws, and a review of the company's background and history. Therefore, pursuant to 21 U.S.C. 952(a) and 958(a), and in accordance with 21 CFR 1301.34, the above named company is granted registration as an importer of the basic classes of controlled substances listed. Dated: June 19, 2008. Joseph T. Rannazzisi, Deputy Assistant Administrator, Office of Diversion Control, Drug Enforcement Administration. [FR Doc. E8-14584 Filed 6-26-08; 8:45 am] BILLING CODE 4410-09-P DEPARTMENT OF JUSTICE Drug Enforcement Administration Importer of Controlled Substances; Notice of Registration By Notice dated March 27, 2008 and published in the **Federal Register** on April 2, 2008, (73 FR 18000), Stepan Company, Natural Products Department, 100 W. Hunter Avenue, Maywood, New Jersey 07607, made application by renewal to the Drug Enforcement Administration

(DEA)to be registered as an importer of Coca Leaves (9040), a basic class of controlled substance listed in schedule II. The company plans to import the listed controlled substance for the manufacture of a bulk controlled substance for distribution to its customer. No comments or objections have been received. DEA has considered the factors in 21 U.S.C. 823(a) and § 952(a) and determined that the registration of Stepan Company to import the basic class of controlled substance is consistent with the public interest and with United States obligations under international treaties, conventions, or protocols in effect on May 1, 1971, at this time. DEA has investigated Stepan Company to ensure that the company's registration is consistent with the public interest. The investigation has included inspection and testing of the company's physical security systems, verification of the company's compliance with state and local laws, and a review of the company's background and history. Therefore, pursuant to 21 U.S.C. 952(a) and 958(a), and in accordance with 21 CFR 1301.34, the above named company is granted registration as an importer of the basic class of controlled substance listed. Dated: June 20, 2008. Joseph T. Rannazzisi, Deputy Assistant Administrator, Office of Diversion Control, Drug Enforcement Administration. [FR Doc. E8-14651 Filed 6-26-08; 8:45 am] BILLING CODE 4410-09-P DEPARTMENT OF JUSTICE Drug Enforcement Administration Manufacturer of Controlled Substances; Notice of Application Pursuant to § 1301.33(a) of Title 21 of the Code of Federal Regulations (CFR), this is notice that on May 22, 2008, Norac Inc., 405 S. Motor Avenue, P.O. Box 577, Azusa, California 91702-3232, made application by letter to the Drug Enforcement Administration

(DEA)to be registered as a bulk manufacturer of Gamma Hydroxybutyric Acid (2010), a basic class of controlled substance listed in schedule I. The company plans to manufacture the listed controlled substance in bulk for sale to its customers. Any other such applicant, and any person who is presently registered with DEA to manufacture such a substance, may file comments or objections to the issuance of the proposed registration pursuant to 21 CFR 1301.33(a). Any such written comments or objections being sent via regular mail should be addressed, in quintuplicate, to the Drug Enforcement Administration, Office of Diversion Control, Federal Register Representative (ODL), Washington, DC 20537, or any being sent via express mail should be sent to Drug Enforcement Administration, Office of Diversion Control, **Federal Register** Representative (ODL), 8701 Morrissette Drive, Springfield, Virginia 22152; and must be filed no later than August 26, 2008. Dated: June 19, 2008. Joseph T. Rannazzisi, Deputy Assistant Administrator, Office of Diversion Control, Drug Enforcement Administration. [FR Doc. E8-14585 Filed 6-26-08; 8:45 am] BILLING CODE 4410-09-P DEPARTMENT OF JUSTICE Drug Enforcement Administration Manufacturer of Controlled Substances; Notice of Application Pursuant to § 1301.33(a) of Title 21 of the Code of Federal Regulations (CFR), this is notice that on May 7, 2008, Archimica, Inc., 2460 W. Bennett Street, Springfield, Missouri 65807-1229, made application by renewal to the Drug Enforcement Administration

(DEA)to be registered as a bulk manufacturer of the basic classes of controlled substances listed in schedule II: Drug Schedule Methylphenidate

(1724)II Phenylacetone

(8501)II Methadone Intermediate

(9254)II The company plans to manufacture the listed controlled substances in bulk for research purposes, and sale to its customers. Any other such applicant and any person who is presently registered with DEA to manufacture such substances may file comments or objections to the issuance of the proposed registration pursuant to 21 CFR 1301.33(a). Any such written comments or objections being sent via regular mail should be addressed, in quintuplicate, to the Drug Enforcement Administration, Office of Diversion Control, **Federal Register** Representative (ODL), Washington, DC 20537, or any being sent via express mail should be sent to Drug Enforcement Administration, Office of Diversion Control, **Federal Register** Representative (ODL), 8701 Morrissette Drive, Springfield, Virginia 22152; and must be filed no later than August 26, 2008. Dated: June 20, 2008. Joseph T. Rannazzisi, Deputy Assistant Administrator, Office of Diversion Control, Drug Enforcement Administration. [FR Doc. E8-14588 Filed 6-26-08; 8:45 am] BILLING CODE 4410-09-P DEPARTMENT OF LABOR Employment and Training Administration [TA-W-61,632] Lear Idea Center, Seating Systems Division, Madison Heights, MI; Amended Certification Regarding Eligibility To Apply for Worker Adjustment Assistance and Alternative Trade Adjustment Assistance In accordance with Section 223 of the Trade Act of 1974 (19 U.S.C. 2273), and Section 246 of the Trade Act of 1974 (26 U.S.C. 2813), as amended, the Department of Labor issued a Certification of Eligibility to Apply for Worker Adjustment Assistance and Alternative Trade Adjustment Assistance on July 5, 2007, applicable to workers of Lear Idea Center, Seating Systems Division, Madison, Michigan. The notice was published in the **Federal Register** on July 19, 2007 (72 FR 39643). At the request of the State agency, the Department reviewed the certification for workers of the subject firm. The workers produced auto seating trim. The certification incorrectly stated that the certification was for workers of Lear Idea Center, Seating Systems Division in Madison, Michigan. The city named in the certification document should have been Madison Heights, not Madison. Therefore, the Department is amending this certification to correctly identify the city in which the worker group is located. The amended notice applicable to TA-W-61,632 is hereby issued as follows: All workers of Lear Idea Center, Seating Systems Division, Madison Heights, Michigan, who became totally separated from employment on May 29, 2006 through July 5, 2009, are eligible to apply for adjustment assistance under Section 223 of the Trade Act of 1974, and are also eligible to apply for alternative trade adjustment assistance under Section 246 of the Trade Act of 1974. Signed at Washington, DC, this 19th day of June 2008. Linda G. Poole, Certifying Officer, Division of Trade Adjustment Assistance. [FR Doc. E8-14604 Filed 6-26-08; 8:45 am] BILLING CODE 4510-FN-P DEPARTMENT OF LABOR Employment and Training Administration [TA-W-62,626] Visteon Systems LLC, Bedford Plant, a Subsidiary of Visteon Corporation, Including On-Site Leased Workers from Securitas, Including Leased Workers From Bedford Logistics, Inc., Bedford, IN; Amended Certification Regarding Eligibility To Apply for Worker Adjustment Assistance and Alternative Trade Adjustment Assistance In accordance with Section 223 of the Trade Act of 1974 (19 U.S.C. 2273), and Section 246 of the Trade Act of 1974 (26 U.S.C. 2813), as amended, the Department of Labor issued a Certification of Eligibility to Apply for Worker Adjustment Assistance and Alternative Trade Adjustment Assistance on February 27, 2008, applicable to workers of Visteon Systems LLC, Bedford Plant, a subsidiary of Visteon Corporation, including on-site leased workers from Securitas, Bedford, Indiana. The notice was published in the **Federal Register** on March 11, 2008 (73 FR 13017). At the request of the petitioners, the Department reviewed the certification for workers of the subject firm. The workers are engaged in the production of automotive components (i.e. fuel delivery modules, wiper reservoirs and canister vent valves). New information shows that leased workers of Bedford Logistics, Inc., Bedford, Indiana are in support of and sufficiently under the control of the Bedford, Indiana facility of Visteon Systems LLC, Bedford Plant. Based on these findings, the Department is amending this certification to include leased workers from Bedford Logistics working in support of the Bedford, Indiana location of the subject firm. The intent of the Department's certification is to include all workers of Visteon Systems LLC, Bedford Plant, a subsidiary of Visteon Corporation who were adversely affected by increased imports of Automotive components (i.e. fuel delivery modules, wiper reservoirs, and canister vent valves). The amended notice applicable to TA-W-62,626 is hereby issued as follows: All workers of Visteon Systems LLC, Bedford Plant, a subsidiary of Visteon Corporation, including on-site leased workers from Securitas and including leased workers from Bedford Logistics in support of Visteon Systems LLC, Bedford Plant, a subsidiary of Visteon Corporation, Bedford, Indiana, who became totally or partially separated from employment on or after January 21, 2008, through February 27, 2010, are eligible to apply for adjustment assistance under Section 223 of the Trade Act of 1974, and are also eligible to apply for alternative trade adjustment assistance under Section 246 of the Trade Act of 1974. Signed at Washington, DC this 20th day of June 2008. Elliott S. Kushner, Certifying Officer, Division of Trade Adjustment Assistance. [FR Doc. E8-14605 Filed 6-26-08; 8:45 am] BILLING CODE 4510-FN-P DEPARTMENT OF LABOR Employment and Training Administration Notice of Determinations Regarding Eligibility To Apply for Worker Adjustment Assistance and Alternative Trade Adjustment Assistance In accordance with Section 223 of the Trade Act of 1974, as amended (19 U.S.C. 2273) the Department of Labor herein presents summaries of determinations regarding eligibility to apply for trade adjustment assistance for workers (TA-W) number and alternative trade adjustment assistance

(ATAA)by (TA-W) number issued during the period of *June 9 through June 13, 2008.* In order for an affirmative determination to be made for workers of a primary firm and a certification issued regarding eligibility to apply for worker adjustment assistance, each of the group eligibility requirements of Section 222(a) of the Act must be met. I. Section (a)(2)(A) all of the following must be satisfied: A. A significant number or proportion of the workers in such workers' firm, or an appropriate subdivision of the firm, have become totally or partially separated, or are threatened to become totally or partially separated; B. the sales or production, or both, of such firm or subdivision have decreased absolutely; and C. increased imports of articles like or directly competitive with articles produced by such firm or subdivision have contributed importantly to such workers' separation or threat of separation and to the decline in sales or production of such firm or subdivision; or II. Section (a)(2)(B) both of the following must be satisfied: A. A significant number or proportion of the workers in such workers' firm, or an appropriate subdivision of the firm, have become totally or partially separated, or are threatened to become totally or partially separated; B. there has been a shift in production by such workers' firm or subdivision to a foreign country of articles like or directly competitive with articles which are produced by such firm or subdivision; and C. One of the following must be satisfied: 1. The country to which the workers' firm has shifted production of the articles is a party to a free trade agreement with the United States; 2. the country to which the workers' firm has shifted production of the articles to a beneficiary country under the Andean Trade Preference Act, African Growth and Opportunity Act, or the Caribbean Basin Economic Recovery Act; or 3. there has been or is likely to be an increase in imports of articles that are like or directly competitive with articles which are or were produced by such firm or subdivision. Also, in order for an affirmative determination to be made for secondarily affected workers of a firm and a certification issued regarding eligibility to apply for worker adjustment assistance, each of the group eligibility requirements of Section 222(b) of the Act must be met.

(1)Significant number or proportion of the workers in the workers' firm or an appropriate subdivision of the firm have become totally or partially separated, or are threatened to become totally or partially separated;

(2)the workers' firm (or subdivision) is a supplier or downstream producer to a firm (or subdivision) that employed a group of workers who received a certification of eligibility to apply for trade adjustment assistance benefits and such supply or production is related to the article that was the basis for such certification; and

(3)either—

(A)the workers' firm is a supplier and the component parts it supplied for the firm (or subdivision) described in paragraph

(2)accounted for at least 20 percent of the production or sales of the workers' firm; or

(B)a loss or business by the workers' firm with the firm (or subdivision) described in paragraph

(2)contributed importantly to the workers' separation or threat of separation. In order for the Division of Trade Adjustment Assistance to issue a certification of eligibility to apply for Alternative Trade Adjustment Assistance

(ATAA)for older workers, the group eligibility requirements of Section 246(a)(3)(A)(ii) of the Trade Act must be met. 1. Whether a significant number of workers in the workers' firm are 50 years of age or older. 2. Whether the workers in the workers' firm possess skills that are not easily transferable. 3. The competitive conditions within the workers' industry ( *i.e.* , conditions within the industry are adverse). Affirmative Determinations for Worker Adjustment Assistance The following certifications have been issued. The date following the company name and location of each determination references the impact date for all workers of such determination. The following certifications have been issued. The requirements of Section 222(a)(2)(A) (increased imports) of the Trade Act have been met. *None.* The following certifications have been issued. The requirements of Section 222(a)(2)(B) (shift in production) of the Trade Act have been met. *None.* The following certifications have been issued. The requirements of Section 222(b) (supplier to a firm whose workers are certified eligible to apply for TAA) of the Trade Act have been met. *None.* The following certifications have been issued. The requirements of Section 222(b) (downstream producer for a firm whose workers are certified eligible to apply for TAA based on increased imports from or a shift in production to Mexico or Canada) of the Trade Act have been met. *None.* Affirmative Determinations for Worker Adjustment Assistance and Alternative Trade Adjustment Assistance The following certifications have been issued. The date following the company name and location of each determination references the impact date for all workers of such determination. The following certifications have been issued. The requirements of Section 222(a)(2)(A) (increased imports) and Section 246(a)(3)(A)(ii) of the Trade Act have been met. *TA-W-63,187; Baldwin Hardware Corporation, Reading, PA: October 12, 2007.* *TA-W-63,231; Steelcase, Inc., Wood Plant, Caledonia, MI: April 18, 2007* . *TA-W-63,251; Culp Woven Fabrics, A Division of Culp, Inc., Anderson, SC: April 23, 2007* . *TA-W-63,275; Plastic Trim International, Inc., Beavercreek Division, Dayton, OH: April 28, 2007* . *TA-W-63,302; BCS Cuyahoga, LLC, Subsidiary of BCS Industries, LLC, Solon, OH: May 2, 2007* . *TA-W-63,357; Hanes Industries, A Subsidiary of Hanes Companies, Conover, NC: May 7, 2007* . *TA-W-63,391; Pope and Talbot, Inc., Pulp Division, Halsey, OR: May 13, 2007* . *TA-W-63,420D; Bernhardt Furniture Company, Plant 10, Cherryville, NC: May 20, 2007* . *TA-W-62,825; Smart Parts, Inc., Loyalhanna, PA: February 9, 2007* . *TA-W-62,825A; Smart Parts, Inc., Greensburg,PA: February 9, 2007* . *TA-W-63,053; Mohawk ESV, Inc., Hiawassee, GA: March 12, 2007* . *TA-W-63,181; The Hall China Company, East Liverpool, OH: June 9, 2007* . *TA-W-63,211; Glen Gery Corporation, Somerville, NJ: April 11, 2007* . *TA-W-63,228; Galey and Lord Industries, LLC, dba Swift Galey, Columbus, GA: April 21, 2007* . *TA-W-63,228A; Galey and Lord Industries, LLC, dba Swift Galey, Atlanta, GA: April 21, 2007* . *TA-W-63,228B; Galey and Lord Industries, LLC, dba Swift Galey, Employees of Galey and Lord, Inc. LLC, Greensboro, NC: April 21, 2007* . *TA-W-63,228C; Galey and Lord Industries, LLC, dba Swift Galey, Employees of Galey and Lord, Inc. LLC, Los Angeles, CA: April 21, 2007* . *TA-W-63,228D; Galey and Lord Industries, LLC, dba Swift Galey, Employees of Galey and Lord, Inc. LLC, Yeardley, PA: April 21, 2007* . *TA-W-63,228E; Galey and Lord Industries, LLC, dba Swift Galey, Employees of Galey and Lord, Inc. LLC, San Francisco, CA: April 21, 2007* . *TA-W-63,228F; Galey and Lord Industries, LLC, dba Swift Galey, Employees of Galey and Lord, Inc. LLC, Dallas, TX: April 21, 2007* . *TA-W-63,228G; Galey and Lord Industries, LLC, dba Swift Galey, New York, NY: April 21, 2007* . *TA-W-63,232; GAE Warren, LLC, Warren, OH: April 21, 2007* . *TA-W-63,319; Hood Industries Inc., Subsidiary of Hood* . The following certifications have been issued. The requirements of Section 222(a)(2)(B) (shift in production) and Section 246(a)(3)(A)(ii) of the Trade Act have been met. *TA-W-63,138; Prettl Electric Corporation, Greenville, SC: April 3, 2007* . *TA-W-63,271; Horton Automatics, Corpus Christi, TX: April 10, 2007* . *TA-W-63,331; Burlington Finishing Plant, BWW Division, Burlington, NC: May 5, 2010* . *TA-W-63,411; Pass and Seymour, Concord, NC: May 19, 2007* . *TA-W-63,413; Spicer Driveshaft, LLC, A Subsidiary of Dana Corp., Marion, IN: May 12, 2007* . *TA-W-63,448; Prestolite Wire, LLC, Tifton, GA: May 29, 2007* . *TA-W-63,480; Mitsubishi Kagaku Imaging Corporation, Virginia Division, OPC Manufacturing Group, Chesapeake, VA: May 20, 2007* . *TA-W-63,284; Kimball International General Office, A Subsidiary of Kimball International, Jasper, IN: April 29, 2007* . *TA-W-63,443; DME Company, Lewiston, PA: May 28, 2007* . *TA-W-63,465; Sara Campbell LTD, Boston, MA: June 2, 2007* . The following certifications have been issued. The requirements of Section 222(b) (supplier to a firm whose workers are certified eligible to apply for TAA) and Section 246(a)(3)(A)(ii) of the Trade Act have been met. *None.* The following certifications have been issued. The requirements of Section 222(b) (downstream producer for a firm whose workers are certified eligible to apply for TAA based on increased imports from or a shift in production to Mexico or Canada) and Section 246(a)(3)(A)(ii) of the Trade Act have been met. *None.* Negative Determinations for Alternative Trade Adjustment Assistance In the following cases, it has been determined that the requirements of 246(a)(3)(A)(ii) have not been met for the reasons specified. The Department has determined that criterion

(1)of Section 246 has not been met. The firm does not have a significant number of workers 50 years of age or older. *None* . The Department has determined that criterion

(2)of Section 246 has not been met. Workers at the firm possess skills that are easily transferable. *None* . The Department has determined that criterion

(3)of Section 246 has not been met. Competition conditions within the workers' industry are not adverse. *None* . Negative Determinations for Worker Adjustment Assistance and Alternative Trade Adjustment Assistance In the following cases, the investigation revealed that the eligibility criteria for worker adjustment assistance have not been met for the reasons specified. Because the workers of the firm are not eligible to apply for TAA, the workers cannot be certified eligible for ATAA. The investigation revealed that criteria (a)(2)(A)(I.A.) and (a)(2)(B)(II.A.) (employment decline) have not been met. *TA-W-62,892; Barnes Aerospace, Ceramics Division, Windsor, CT.* *TA-W-62,892A; Barnes Aerospace, Windsor Division, Windsor, CT.* *TA-W-63,231A; Steelcase, Inc., Global Headquarters Division, Grand Rapids, MI.* *TA-W-63,231B; Steelcase, Inc., Corporate Development Center, Caledonia, MI.* *TA-W-63,231C; Steelcase, Inc., Kentwood West Plant, Caledonia, MI.* *TA-W-63,231D; Steelcase, Inc., Kentwood East Plant, Caledonia, MI.* *TA-W-63,231E; Steelcase, Inc., Physical Distribution Center, Kentwood, MI.* *TA-W-63,231F; Steelcase, Inc., Steelcase University, Kentwood, MI.* *TA-W-63,231G; Steelcase, Inc., Brayton International Division, High Point, NC.* *TA-W-63,231H; Steelcase, Inc., Athens Division, Athens, AL.* *TA-W-63,231I; Steelcase, Inc., Details Division, Athens, AL.* *TA-W-63,231J; Steelcase, Inc., Athens Division, Athens, AL.* *TA-W-63,231K; Steelcase, Inc., Vecta Division, Grand Prairie, TX.* *TA-W-63,231L; Steelcase, Inc., Hedberg Data Systems Division, East Windsor, CT.* *TA-W-63,420; Bernhardt Furniture Company, Corporate Office, Lenoir, NC.* *TA-W-63,420A; Bernhardt Furniture Company, Bernhardt Central Warehouse, Lenoir, NC.* *TA-W-63,420B; Bernhardt Furniture Company, Plant 6/11, Lenoir, NC.* *TA-W-63,420C; Bernhardt Furniture Company, Plant 9, Shelby, NC.* The investigation revealed that criteria (a)(2)(A)(I.B.) (Sales or production, or both, did not decline) and (a)(2)(B)(II.B.) (shift in production to a foreign country) have not been met. *TA-W-63,404; FMC Corporation, South Charleston, WV.* *TA-W-63,418; Gramercy Jewelry Manufacturing Corp., New York, NY.* *TA-W-63,480A; Mitsubishi Kagaku Imaging Corporation, Virginia Division, Toner Manufacturing Group, Elkton, MD.* The investigation revealed that criteria (a)(2)(A)(I.C.) (increased imports) and (a)(2)(B)(II.B.) (shift in production to a foreign country) have not been met. *TA-W-62,981; Georgia Pacific Wood Products South, LLC, Wood Products Division, Plywood Plant, Springhill, LA.* *TA-W-62,981A; Georgia Pacific Wood Products South, LLC, Wood Products Division, Lumber Operations, Springhill, LA.* *TA-W-63,069; Milprint, Inc., A Subsidiary of Bemis Company, Lancaster, WI.* *TA-W-63,091; FarNorth Window and Doors, Subsidiary of Scherer Brothers Lumber Co., Window & Door Division, Champlin, MN.* *TA-W-63,131; Pfizer, Inc., Terre Haute, IN.* *TA-W-63,220; Starbrook Industries, Inc., Covington, OH.* The workers' firm does not produce an article as required for certification under Section 222 of the Trade Act of 1974. *TA-W-63,209; Novartis Pharmaceuticals Corporation, Customer Call Center, East Hanover, NJ.* *TA-W-63,327; Logistics Services, Inc., Fenton, MO.* *TA-W-63,356; TRG Customer Solutions, Greensburg, PA.* The investigation revealed that criteria of Section 222(b)(2) has not been met. The workers' firm (or subdivision) is not a supplier to or a downstream producer for a firm whose workers were certified eligible to apply for TAA. *None* . I hereby certify that the aforementioned determinations were issued during the period of *June 9 through June 13, 2008* . Copies of these determinations are available for inspection in Room C-5311, U.S. Department of Labor, 200 Constitution Avenue, NW., Washington, DC 20210 during normal business hours or will be mailed to persons who write to the above address. Dated: June 20, 2008. Linda G. Poole, Certifying Officer, Division of Trade Adjustment Assistance. [FR Doc. E8-14603 Filed 6-26-08; 8:45 am] BILLING CODE 4510-FN-P DEPARTMENT OF LABOR Employment and Training Administration [TA-W-63,547] Lapeer Metal Stamping, Lapeer, MI; Notice of Termination of Investigation Pursuant to Section 221 of the Trade Act of 1974, as amended, an investigation was initiated on June 17, 2008 in response to a petition filed on behalf of workers of Lapeer Metal Stamping, Lapeer, Michigan. The petitioning group of workers are covered under by the earlier petition, (TA-W-63,469) filed on June 3, 2008 that is the subject of an ongoing investigation for which a determination has not yet been issued. Further investigation in this case would duplicate efforts and serve no purpose; therefore the investigation under this petition has been terminated. Signed at Washington, DC, this 20th day of June, 2008. Linda G. Poole, Certifying Officer, Division of Trade Adjustment Assistance. [FR Doc. E8-14607 Filed 6-26-08; 8:45 am] BILLING CODE 4510-FN-P DEPARTMENT OF LABOR Employment and Training Administration [TA-W-63,557] Royal Home Fashions, Plant 4, a Subsidiary Of Croscill, Inc., Durham, NC; Notice of Termination of Investigation Pursuant to Section 221 of the Trade Act of 1974, as amended, an investigation was initiated on June 18, 2008 in response to a petition filed by a company official on behalf of the workers of Royal Home Fashions, Plant 4, a subsidiary of Croscill, Inc., Henderson, North Carolina. The workers are covered by active certification (TA-W-59,843), which expires on August 31, 2008. Consequently, further investigation in this case would serve no purpose, and the investigation has been terminated. Signed at Washington, DC this 20th day of June 2008. Richard Church, Certifying Officer, Division of Trade Adjustment Assistance. [FR Doc. E8-14602 Filed 6-26-08; 8:45 am] BILLING CODE 4510-FN-P DEPARTMENT OF LABOR Employment and Training Administration [TA-W-63,401] Unifi, Inc., Staunton, VA; Notice of Termination of Investigation Pursuant to Section 221 of the Trade Act of 1974, as amended, an investigation was initiated on May 19, 2008 in response to a petition filed by a company official on behalf of workers at Unifi, Inc., Staunton, Virginia. The company has requested that the petition be withdrawn. The company intends to submit a new petition closer to the date of separation or threat of separation. Consequently, further investigation in this case would serve no purpose, and the investigation has been terminated. Signed at Washington, DC, this 19th day of June 2008. Elliott S. Kushner, Certifying Officer, Division of Trade Adjustment Assistance. [FR Doc. E8-14606 Filed 6-26-08; 8:45 am] BILLING CODE 4510-FN-P FEDERAL MINE SAFETY AND HEALTH REVIEW COMMISSION Sunshine Act Meeting Time and Date: 10 a.m., Thursday, July 24, 2008. Place: The Richard V. Backley Hearing Room, 9th Floor, 601 New Jersey Avenue, NW., Washington, DC. Status: Open. Matters to be Considered: The Commission will consider and act upon the following in open session: *Secretary of Labor* v. *National Cement Company of California,* Docket No. WEST 2004-182-RM. (Issues include whether the Secretary properly interpreted section 3(h)(1) of the Mine Act in concluding that MSHA had jurisdiction over an access road leading to a cement plant.) Any person attending this meeting who requires special accessibility features and/or auxiliary aids, such as sign language interpreters, must inform the Commission in advance of those needs. Subject to 29 CFR 2706.150(a)(3) and 2706.160(d). Contact Person for More Info: Jean Ellen

(202)434-9950/(202) 708-9300 for TDD Relay/1-800-877-8339 for toll free. Sandra G. Farrow, Acting Chief Docket Clerk. [FR Doc. E8-14591 Filed 6-26-08; 8:45 am] BILLING CODE 6735-01-M NATIONAL FOUNDATION ON THE ARTS AND THE HUMANITIES National Endowment for the Arts; Proposed Collection; Comment Request ACTION: Notice. SUMMARY: The National Endowment for the Arts (NEA), as part of its continuing effort to reduce paperwork and respondent burden, conducts a preclearance consultation program to provide the general public and federal agencies with an opportunity to comment on proposed and/or continuing collections of information in accordance with the Paperwork Reduction Act of 1995 (PRA95) [44 U.S.C. 3506(c)(A)]. This program helps to ensure that requested data can be provided in the desired format, reporting burden (time and financial resources) is minimized, collection instruments are clearly understood, and the impact of collection requirements on respondents can be properly assessed. Currently, the NEA is soliciting comments concerning the proposed information collection to evaluate the “Operation Homecoming: Literary Programming for Veterans and Their Families” initiative. A copy of the current information collection request can be obtained by contacting the office listed below in the address section of this notice. DATES: Written comments must be submitted to the office listed in the address section below on or before August 27, 2008. The NEA is particularly interested in comments which: • Evaluate whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility; • Evaluate the accuracy of the agency's estimate of the burden of the proposed collection of information including the validity of the methodology and assumptions used; • Enhance the quality, utility, and clarity of the information to be collected; and • Minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology, e.g., permitting electronic submissions of responses. ADDRESSES: Michael McLaughlin, National Endowment for the Arts, 1100 Pennsylvania Avenue, NW., Room 710, Washington, DC 20506-0001, telephone

(202)682-5457 (this is not a toll-free number), fax

(202)682-5613. Kathleen Edwards, Director, Administrative Services, National Endowment for the Arts. [FR Doc. E8-14547 Filed 6-26-08; 8:45 am] BILLING CODE 7537-01-P NUCLEAR REGULATORY COMMISSION [Docket No 50-391] Tennessee Valley Authority; Watts Bar Nuclear Plant, Unit 2; Environmental Assessment and Finding of No Significant Impact The U.S. Nuclear Regulatory Commission

(NRC)is considering extending the latest construction completion date specified in Construction Permit No. CPPR-92 issued to Tennessee Valley Authority (permittee, TVA) for the Watts Bar Nuclear Plant (WBN), Unit 2. The facility is located at the permittee's site on the west branch of the Tennessee River approximately 50 miles northeast of Chattanooga, Tennessee. Environmental Assessment Identification of Proposed Action The proposed action would extend the latest construction completion date of Construction Permit No. CPPR-92 from December 31, 2010 to March 31, 2013. The proposed action is in response to the permittee's request dated May 8, 2008. This request superseded an earlier letter dated March 6, 2008. The proposed extension will not allow any work to be performed that is not already allowed by the existing construction permit. The extension will merely grant the permittee more time to complete construction in accordance with the previously approved construction permit. The Need for the Proposed Action The proposed action is needed to give the permittee adequate time to complete construction of WBN Unit 2. In a July 14, 2000 letter, TVA confirmed that WBN Unit 2 met the NRC's definition of a deferred plant, as described in Generic Letter 87-15, “Policy Statement on Deferred Plants.” Subsequently, on August 3, 2007, TVA informed the Commission of its intent to complete construction and licensing of WBN Unit 2 by April 1, 2012; this letter was submitted in accordance with the Policy Statement on Deferred Plants. TVA provided information requested by the Policy Statement, and also informed the Commission that it would resume construction activities no sooner than December 3, 2007. These activities are within the scope of the existing construction permit, which expires December 31, 2010. Environmental Impacts of the Proposed Action The environmental impacts associated with the construction of the facility have been previously discussed and evaluated in TVA's Final Environmental Statement for construction (FES-CP) of WBN, Units 1 and 2, issued on November 9, 1972. NRC staff evaluated the environmental impacts of construction and operation of this plant, issuing comments on TVA's FES-CP as part of its review. In December 1978, NRC staff issued NUREG-0498, “Final Environmental Statement Related to Operation of Watts Bar Nuclear Plant Units 1 and 2,” for the operating-license stage (FES-OL), addressing environmental impacts of construction activities not addressed previously in TVA's FES-CP. The activities included:

(1)Construction of the transmission route for the Watts Bar—Volunteer 500 kV line,

(2)construction of the settling pond for siltation control for construction runoff at a different location from that originally proposed in the FES-CP, and

(3)the relocation of the blowdown diffuser from the originally proposed site indicated in the FES-CP. The staff addressed the terrestrial and aquatic environmental impacts in the FES-OL, as well as historic and archeological impacts, and concluded that the assessment presented in the FES-CP remains valid. NUREG-0498, Supplement 1 was issued in April 1995. Environmental issues evaluated included changes to regional demography, natural resource use, meteorology, ecology, impacts to humans and the environment, severe accident mitigation design alternatives, and socioeconomic impacts, including environmental justice issues. The staff concluded that there were no significant changes to the environmental impacts discussed in the 1978 FES-OL due to changes in plant design or operation, or changes in the environment. Furthermore, the staff concluded that no additional impacts not previously discussed in the NRC's 1978 FES-OL related to construction of Unit 2 were expected. On February 15, 2008, TVA submitted “Watts Bar Nuclear Plant (WBN)—Unit 2—Final Supplemental Environmental Impact Statement [FSEIS] For the Completion and Operation of Unit 2,” to the NRC. This FSEIS was completed in June 2007, and was submitted in support of TVA's operating license application for WBN Unit 2. It also includes TVA's evaluation of the environmental impacts of construction. The licensee has no plans to construct additional transmission lines or disturb any land not discussed in previous environmental reviews. Impacts on the Federal threatened and endangered species list issued by the Fish and Wildlife Service were evaluated in previous NRC environmental reviews. No additional impacts are expected. Completed construction of WBN Unit 2 includes major structures such as the containment, turbine building, control building, and equipment such as the reactor pressure vessel, reactor coolant system piping, and steam generators. Installation of equipment shared with WBN Unit 1, such as diesel generators, was completed prior to issuance of the Unit 1 operating license in 1996. The majority of construction activities will take place within structures already completed. Therefore, most of the construction impacts discussed in the FES have already occurred. As discussed in TVA's FSEIS, additional onsite construction environmental impacts will be small, mitigated by use of good construction practices. Socioeconomic impacts are similar to those previously evaluated by the NRC. As construction proceeds, workers moving to the area will increase demand for services such as schools and recreational facilities. In its June 2007 FSEIS, in anticipation of a decision to resume construction, TVA stated that it “...would designate certain counties as impacted by the construction process. This [designation] would make them eligible for a supplemental allocation from TVA's annual tax equivalent payment under Tennessee law. These funds could be used by counties to address impacts on county services.” These payments mitigate the effects of new workers living in the area. The requested extension of the construction permit only extends the period of construction as described in the FES, and does not involve any different impacts as described and analyzed in the original and updated environmental impact statements. The cumulative impacts of the extended construction period are small, and mitigated, as discussed above. Based on the foregoing, the NRC staff has concluded that the proposed action would have no significant environmental impact. Since this action would only extend the period of construction activities described in the FES, it does not involve any different impacts or a significant change to those impacts described and analyzed in the original environmental impact statement. Consequently, an environmental impact statement addressing the proposed action is not required. Alternatives to the Proposed Action A possible alternative to the proposed action would be to deny the request, or the no-action alternative. This alternative would result in expiration of the construction permit for Watts Bar, Unit 2. This option would require submittal of another application for construction in order to allow the permittee to complete construction of the facility with no significant environmental benefit. The environmental impacts of the proposed action and alternative action are similar. Denial of the request could also result in TVA seeking other sources of electrical power. Siting and constructing new power generating facilities would result in their own environmental impacts, and does not provide an obvious environmental benefit versus the proposed construction permit extension, especially given the large degree of construction already completed for WBN Unit 2. Alternative Use of Resources This action does not involve the use of resources not previously considered in the FES for Watts Bar, Units 1 and 2. Agencies and Persons Contacted In accordance with its stated policy, on May 28, 2008, the staff consulted with officials from the State of Tennessee, including Alan Leiserson, Legal Services Director of the Tennessee Department of Environment and Conservation, regarding the environmental impact of the proposed action. The State officials had no comments. Finding of No Significant Impact On the basis of the environmental assessment, the NRC concludes that this action will not have a significant effect on the quality of the human environment. Accordingly, the NRC has determined not to prepare an environmental impact statement for this action. For further details with respect to this action, see the licensee's request for extension dated May 8, 2008. Documents may be examined, and/or copied for a fee, at the NRC's Public Document Room, located at One White Flint North, 11555 Rockville Pike (first floor), Rockville, Maryland. Publicly available records will be accessible electronically from the Agencywide Documents Access and Management System (ADAMS) Public Electronic Reading room on the internet at the NRC Web site, *http://www.nrc.gov/reading-rm/adams.html.* Persons who do not have access to ADAMS or who encounter problems in accessing the documents located in ADAMS should contact the NRC PDR Reference staff by telephone at 1-800-397-4209 or send an e-mail to *pdr@nrc.gov.* Dated at Rockville, Maryland this 20th day of June 2008. For the Nuclear Regulatory Commission. L. Raghavan, Chief, Watts Bar Special Projects Branch, Division of Operating Reactor Licensing, Office of Nuclear Reactor Regulation. [FR Doc. E8-14594 Filed 6-26-08; 8:45 am] BILLING CODE 7590-01-P NUCLEAR REGULATORY COMMISSION Advisory Committee on Reactor Safeguards (ACRS); Subcommittee Meeting on Power Uprates (Millstone Unit 3); Corrected Notice of Meeting (Corrected To Note Millstone Unit 3 Instead of Hope Creek) The ACRS Subcommittee on Power Uprates will hold a meeting on July 8, 2008, at 11545 Rockville Pike, Rockville, Maryland, Room T-2B3. The meeting will be open to public attendance, with the exception of portions that may be closed to discuss proprietary information pursuant to 5 U.S.C. 552b(c)(4) for presentations covering information that is proprietary to Dominion Nuclear Connecticut, Inc.

(DNC)or its contractor Westinghouse Electric Company, LLC. The agenda for the subject meeting shall be as follows: *Tuesday, July 8, 2008—9 a.m.-5 p.m.* The Subcommittee will review the staff's safety evaluation associated with the Millstone Power Station Unit 3 stretch power uprate. The Subcommittee will hear presentations by and hold discussions with representatives of the NRC staff, DNC, Westinghouse, and other interested persons regarding this matter. The Subcommittee will gather information, analyze relevant issues and facts, and formulate proposed positions and actions, as appropriate, for deliberation by the full Committee. Members of the public desiring to provide oral statements and/or written comments should notify the Designated Federal Officer, Mr. David Bessette at 301-415-8065, five days prior to the meeting, if possible, so that appropriate arrangements can be made. Electronic recordings will be permitted only during those portions of the meeting that are open to the public. Detailed procedures for the conduct of and participation in ACRS meetings were published in the **Federal Register** on September 26, 2007, (72 FR 54695). Further information regarding this meeting can be obtained by contacting the Designated Federal Official between 8:45 a.m. and 5:30 p.m. (ET). Persons planning to attend this meeting are urged to contact the above named individual at least two working days prior to the meeting to be advised of any potential changes to the agenda. Dated: June 23, 2008. Antonio Dias, Chief, Reactor Safety Branch B. [FR Doc. E8-14595 Filed 6-26-08; 8:45 am] BILLING CODE 7590-01-P SECURITIES AND EXCHANGE COMMISSION Sunshine Act Meeting Federal Register Citation of Previous Announcement: [73 FR 35427, June 23, 2008]. Status: Closed Meeting. Place: 100 F Street, NE., Washington, DC. Date and Time of Previously Announced Meeting: Thursday, June 26, 2008 at 10 a.m. Change in the Meeting: Cancellation of Meeting. The Closed Meeting scheduled for Thursday, June 26, 2008 has been cancelled. For further information please contact the Office of the Secretary at

(202)551-5400. June 24, 2008. Florence E. Harmon, Acting Secretary. [FR Doc. E8-14611 Filed 6-26-08; 8:45 am] BILLING CODE 8010-01-P SECURITIES AND EXCHANGE COMMISSION [Release No. 34-58004; File No. SR-FINRA-2008-009] Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Order Approving Proposed Rule Change to the Code of Arbitration Procedure for Customer Disputes and the Code of Arbitration Procedure for Industry Disputes To Amend the Chairperson Eligibility Requirements June 23, 2008. I. Introduction On March 12, 2008, the Financial Industry Regulatory Authority, Inc. (“FINRA”) (f/k/a National Association of Securities Dealers, Inc. (“NASD”)) filed with the Securities and Exchange Commission (“SEC” or “Commission”) pursuant to section 19(b)(1) of the Securities Exchange Act of 1934 (“Act”) 1 and Rule 19b-4 thereunder, 2 a proposed rule change relating to amendments to NASD Rule 12400(c) of the Code of Arbitration Procedure for Customer Disputes (“Customer Code”) and NASD Rule 13400(c) of the Code of Arbitration Procedure for Industry Disputes (“Industry Code”). The proposed rule change was published for comment in the **Federal Register** on March 25, 2008. 3 The Commission received five comment letters in response to the proposed rule change. 4 This order approves the proposed rule change. 1 15 U.S.C. 78s(b)(1). 2 17 CFR 240.19b-4. 3 *See* Securities Exchange Act Release No. 34-57529 (March 19, 2008); 73 FR 15817 (Mar. 25, 2008). 4 *See* letter from Scot D. Bernstein, dated April 4, 2008 (“Bernstein letter”); letter from William A. Jacobson, Esq., Associate Clinical Professor, Director, Securities Law Clinic, Cornell Law School, dated April 15, 2008 (“Cornell letter”); letter from Lawrence S. Schultz, President, Public Investors Arbitration Association, dated April 16, 2008 (“PIABA letter”); letter from Karen Lockwood, dated May 12, 2008 (“Lockwood letter”); and letter from Barry D. Estell, Esquire, dated May 22, 2008 (“Estell letter”). II. Description of the Proposed Rule Change The proposed rule change amends the chairperson eligibility requirements under Rule 12400(c) of the Customer Code and Rule 13400(c) of the Industry Code. On January 24, 2007, the SEC approved the Customer and Industry Codes (collectively referred to as “Codes”). 5 The Codes reorganized the dispute resolution rules into separate procedural codes, simplified the language of the old NASD Code of Arbitration Procedure, codified current practices, and implemented several substantive changes. One such substantive change involved improving the arbitrator selection process by creating and maintaining a new roster of arbitrators who are qualified to serve as chairpersons. 5 *See* Securities Exchange Act Release No. 55158 (January 24, 2007); 72 FR 4574 (January 31, 2007) (File Nos. SR-NASD-2003-158 and SR-NASD-2004-011). The new Codes became effective on April 16, 2007. Under the Codes, arbitrators are eligible for the chairperson roster if they have completed chairperson training provided by FINRA 6 or have substantially equivalent training or experience, and satisfy one of two remaining requirements of the rule. 7 In the rule filing proposing this change, FINRA explained that “substantially equivalent training or experience would include service as a judge or administrative hearing officer, chairperson training offered by another recognized dispute resolution forum, or the like. Decisions regarding whether particular training or experience other than FINRA chairperson training would qualify under this provision would be in the sole discretion of the Director.” 8 In referring to the “substantially equivalent training or experience” criterion (hereinafter, “substantially equivalent”), the proposal also stated that FINRA believed that the proposal would allow arbitrators of all professional backgrounds to qualify as chairpersons. 9 FINRA believed that this criterion would help ensure that the forum could meet the demands of the Codes concerning the new chairperson roster, while allowing FINRA to continue to administer effectively the arbitrator selection process. 6 Although some of the events referenced in this rule filing occurred prior to the formation of FINRA, the rule filing refers to FINRA throughout for simplicity. 7 Rule 12400(c) of the Customer Code and Rule 13400(c) of the Industry Code. 8 *See* Securities Exchange Act Release No. 51856 (June 15, 2005); 70 FR 36442, at 36446 (June 23, 2005). 9 *Id* . In the year since the Codes were approved, FINRA has determined that the “substantially equivalent” criterion has not been essential to creating and maintaining the chairperson roster, and therefore proposed to remove this criterion from the rule. FINRA notes that all arbitrators currently coded as chairpersons have completed the FINRA Chairperson Training course (chair training), 10 and the chair training has never been waived for an arbitrator claiming to satisfy the “substantially equivalent” criterion. FINRA believes that all arbitrators wishing to serve as chairpersons would benefit from the information contained in the chair training, which instructs arbitrators on the added responsibilities of arbitrators assuming the essential role of chairperson in the FINRA forum. Moreover, FINRA believes that removing the “substantially equivalent” criterion would make the chairperson eligibility standards more objective and uniform, thereby eliminating any perception that large numbers of arbitrators may be added to the chairperson roster without the benefit of the chair training. 10 The online Chairperson training course costs $50 and is available at *http://www.finra.org/ArbitrationMediation/ResourcesforArbitratorsandMediators/ArbitratorTraining/ArbitratorTrainingPrograms/index.htm* (last visited March 5, 2008). III. Comment Letters The Commission received five comment letters on the proposal. 11 Three commenters opposed the proposal; 12 one commenter urged the Commission to postpone taking final action on the proposed rule change pending further study; 13 and one commenter offered no opinion on the proposal. 14 11 *See supra* , footnote 3. 12 Bernstein, PIABA and Estell letters. 13 Cornell letter. 14 Lockwood letter. Two commenters argued that the amendments would further reduce the potential size of FINRA's pool of arbitrators who could be eligible to serve as chair by removing the “substantially equivalent” criterion from the rule. 15 15 PIABA and Estell letters. In a letter to the Commission, FINRA responded to these comments, stating that the proposal will not narrow the pool of arbitrators who could be eligible to serve as chair. 16 FINRA explained that, in the year since the Codes were approved, the substantially equivalent criterion has proved irrelevant to creating and maintaining the chairperson roster. 17 Further, FINRA explained that all arbitrators currently coded as chairpersons have completed the FINRA Chairperson Training course (chair training) and that FINRA has never waived the chair training for an arbitrator under the substantially equivalent criterion. 18 Finally, FINRA suggested that this criterion has had no impact on its ability to maintain or expand the chairperson roster, and is therefore not necessary. 19 16 *See* letter from Mignon McLemore, Assistant Chief Counsel, FINRA Dispute Resolution, dated June 2, 2008 (“FINRA letter”). 17 FINRA letter. 18 *Id* . 19 *Id* . Three commenters contended that by removing the substantially equivalent criterion, FINRA would be, in effect, implementing a mandatory arbitrator training requirement, which would give FINRA undue control over the arbitrators who may serve as chairs. 20 20 Bernstein, PIABA and Estell letters. FINRA responded that the proposal would, instead, result in less staff discretion because staff would not be assessing the arbitrator's prior experience or training to determine whether it was substantially equivalent to FINRA chair training. 21 Under the proposal, arbitrators would be required to take FINRA's online chair training to become chair eligible. FINRA indicated that this requirement (which is easily measured) would make chair eligibility determinations more objective, because staff would not have to decide whether an arbitrator's experience meets the substantially equivalent threshold. 22 FINRA stated that it believes the proposed amendments to the chair eligibility standards are reasonable and, along with the rule's other criteria, will provide investors with access to well-trained and well-qualified arbitrators. 23 21 FINRA letter. 22 *Id* . 23 *Id* . One commenter suggested that chair training should not be a prerequisite to appointment as chair. 24 Rather, the commenter suggested that FINRA could require that arbitrators, appointed as chair, complete the training prior to the initial pre-hearing conference (IPHC). 25 24 Cornell letter at footnote 2. 25 Cornell letter. *See also* FINRA letter, footnote 10, stating that “a pre-hearing conference is a hearing session that takes place before the hearing on the merits. Rule 12100(t) of the Customer Code and Rule 13100(t) of the Industry Code.” FINRA responded by stating that it has considered this suggestion, but concluded that it would be unworkable in its forum. 26 FINRA pointed out that there could be instances in which an arbitrator is appointed as chair, but does not want to serve as the chair, refuses to take the chair training, or delays taking the training and does not complete it by the time of the IPHC. 27 In such instances, FINRA explained, the case would be delayed while either the arbitrator is removed and another is appointed, or the IPHC is re-scheduled to give the arbitrator additional time to take the training. 28 FINRA also stated that this suggestion would create a significant administrative burden on staff, as staff would be required to monitor continuously the arbitrators' training reports to ensure that they have completed the chair training prior to IPHCs. 29 For these reasons, FINRA declined to amend the proposal to implement this suggestion. 30 26 FINRA letter. 27 *Id.* 28 *Id.* 29 *Id.* 30 *Id.* One commenter requested that FINRA make available arbitrator selection records, beyond information publicly available from the Arbitration Awards Online database, so that it could be analyzed to determine whether arbitrators who award punitive or large compensatory awards are appointed to cases with less frequency due to strikes from industry parties, and whether the fragmentation of the random selection process through a chair-qualified slot exacerbates the problem. 31 31 Cornell letter. FINRA responded that its arbitrator selection records are proprietary and confidential. 32 FINRA explained, that the arbitrator selection records are generated during the resolution of a private matter between parties and contain the parties' confidential information, such as their striking and ranking choices. 33 Further, FINRA stated that it does not make this information available to the public because it could inhibit the parties' decisions during the arbitration process, which would compromise the integrity of the arbitration process. 34 For these reasons, FINRA declined to make this information available. 35 32 FINRA letter. 33 *Id.* 34 *Id.* 35 *Id.* Finally, four commenters objected to the existence of the separate chair roster. 36 FINRA stated that it is not proposing to amend the structure of its arbitrator rosters in this rule filing. 37 Further, FINRA noted that these same concerns were addressed by FINRA in connection with the proposal and adoption of the Codes, 38 and the changes to the arbitrator rosters were approved by the SEC. 39 FINRA stated that these comments are, therefore, outside the scope of the rule filing. 40 36 Bernstein, Cornell, PIABA, and Estell letters. 37 FINRA letter. 38 *Id.* citing Response to Comments and Amendment No. 5, May 4, 2006 (File No. SR-NASD-2003-158), at 21-22; *see also* Response to Comments and Partial Amendment 7, August 15, 2006 (File No. SR-NASD-2003-158), at 8. 39 FINRA letter. 40 *Id.* IV. Discussion and Findings After careful review, the Commission finds that the proposed rule change is consistent with the requirements of the Act, and the rules and regulations thereunder that are applicable to a national securities association. 41 In particular, the Commission believes that the proposed rule change is consistent with the provisions of section 15A(b)(6) of the Act, 42 because it would enhance the fairness and neutrality of FINRA's arbitration forum by making the chairperson eligibility rules more objective and uniform. 41 In approving this proposal, the Commission has considered the proposed rule's impact on efficiency, competition and capital formation. *See* 15 U.S.C. 78c(f). 42 15 U.S.C. 78o-(b)(6). V. Conclusions It Is Therefore Ordered, pursuant to section 19(b)(2) of the Act, 43 that the proposed rule change (SR-FINRA-2008-009) be, and hereby is, approved. 43 15 U.S.C. 78s(b)(2). For the Commission, by the Division of Trading and Markets, pursuant to delegated authority. 44 Florence E. Harmon, Acting Secretary. 44 17 CFR 200.30-3(a)(12). [FR Doc. E8-14568 Filed 6-26-08; 8:45 am] BILLING CODE 8010-01-P SECURITIES AND EXCHANGE COMMISSION [Release No. 34-58002; File No. SR-Phlx-2008-42] Self-Regulatory Organizations; Philadelphia Stock Exchange, Inc.; Notice of Filing and Immediate Effectiveness of a Proposed Rule Change Relating to Catastrophic Errors June 23, 2008. Pursuant to section 19(b)(1) of the Securities Exchange Act of 1934 (“Act”) 1 and Rule 19b-4 thereunder, 2 notice is hereby given that on June 17, 2008, the Philadelphia Stock Exchange, Inc. (“Phlx” or “Exchange”) filed with the Securities and Exchange Commission (“Commission”) the proposed rule change as described in Items I and II below, which Items have been substantially prepared by the Exchange. The Exchange filed the proposal as a “non-controversial” proposed rule change pursuant to section 19(b)(3)(A) of the Act 3 and Rule 19b-4(f)(6) thereunder, 4 which renders the proposal effective upon filing with the Commission. The Commission is publishing this notice to solicit comments on the proposed rule change from interested persons. 1 15 U.S.C. 78s(b)(1). 2 17 CFR 240.19b-4. 3 15 U.S.C. 78s(b)(3)(A). 4 17 CFR 240.19b-4(f)(6). I. Self-Regulatory Organization's Statement of the Terms of Substance of the Proposed Rule Change The Phlx proposes to adopt amendments to Exchange Rule 1092 (“Rule”) to:

(i)Define a “Catastrophic Error”;

(ii)extend the time period for member notification to Exchange staff that the member believes it has participated in a trade that resulted from a Catastrophic Error; and

(iii)state in the Rule that, if the parties to such a trade do not agree on an adjustment price, trades resulting from a Catastrophic Error will be adjusted to the Theoretical Price of the affected option series, plus or minus a pre-determined adjustment value, depending on the Theoretical Price of the series. The text of the proposed rule change is available at the Exchange, the Commission's Public Reference Room, and *http://www.phlx.com.* II. Self-Regulatory Organization's Statement of the Purpose of, and Statutory Basis for, the Proposed Rule Change In its filing with the Commission, the Exchange included statements concerning the purpose of, and basis for, the proposed rule change, and discussed any comments it received on the proposed rule change. The text of these statements may be examined at the places specified in Item IV below. Phlx has prepared summaries, set forth in sections A, B, and C below, of the most significant aspects of such statements. A. Self-Regulatory Organization's Statement of the Purpose of, and Statutory Basis for, the Proposed Rule Change 1. Purpose The Exchange states that the purpose of the proposed rule change is to help its members better manage risk by affording them relief from trades that result from a Catastrophic Error. The proposed rule change would address particularly egregious options trading errors, called Catastrophic Errors. An Options Exchange Official 5 would determine that a Catastrophic Error occurred when the execution price of a transaction is higher or lower than the Theoretical Price for the series by an amount equal to at least the minimum amount shown below: 5 *See* Exchange Rules 124(a) and (b). Theoretical price Minimum amount Below $2 $1 $2 to $5 2 Above $5 to $10 5 Above $10 to $50 10 Above $50 to $100 20 Above $100 30 The proposed rule change would also set forth the procedure to be followed when an Exchange member believes that he/she has participated in a trade resulting from a Catastrophic Error. Significantly, the time period within which such a member would be required to notify the Exchange's Market Surveillance staff that such an error may have occurred would be extended well beyond the time period applicable to an Obvious Error under current Phlx Rule 1092. Members would have until 8:30 a.m. Eastern Time on the first trading day following the date on which the Catastrophic Error occurred to make such a notification, except that for such transactions in an expiring options series that take place on an expiration day, an Exchange member must notify the Exchange by 5 p.m. Eastern Time that same day. If it is determined that a Catastrophic Error has occurred, unless both

(all)parties agree to adjust the transaction to a different price, the execution price(s) of the transaction(s) will be adjusted to the theoretical price:

(i)Plus the adjustment value provided below for erroneous buy transactions; and

(ii)minus the adjustment value provided for erroneous sell transactions, as described below: Theoretical price Adjustment value Below $2 $1 $2 to $5 2 Above $5 to $10 3 Above $10 to $50 5 Above $50 to $100 7 Above $100 10 The Exchange believes that the proposed longer time period is appropriate to allow members to discover, and seek relief from, trading errors that result in extreme losses. At the same time, the Exchange believes that the proposed Minimum Amounts required for a trade to qualify as a Catastrophic Error, in combination with the large Adjustment Values, assures that only those transactions where the price of the execution results in very high losses will be eligible for adjustment under the new provisions. While the Exchange believes it is important to identify and resolve trading errors quickly, it also believes it is important to the integrity of the marketplace to have the authority to mitigate extreme losses resulting from errors. A member that requests a review under the proposed rule would be charged $5,000 by the Exchange if there is no adjustment or nullification of the transaction. The initial ruling by the Options Exchange Official would be appealable to the Exchange's Referee. 6 6 *See* Exchange Rule 124, Commentary .02 and current Exchange Rule 1092(f). The Exchange states that it has weighed carefully the need to assure that one market participant is not permitted to receive a windfall at the expense of another market participant that made an Obvious Error, against the need to assure that market participants are not simply being given an opportunity to reconsider poor trading decisions. The Exchange states that, while it believes that the Obvious Error Rule strikes the correct balance in most situations, in some extreme situations, trade participants may not be aware of errors that result in very large losses within the time periods currently required under the rule. In this type of extreme situation, the Exchange believes its members should be given more time to seek relief so that there is a greater opportunity to mitigate very large losses and reduce the corresponding large wind-falls. However, to maintain the appropriate balance, the Exchange believes members should only be given more time when the execution price is much further away from the theoretical price than is required for Obvious Errors so that relief is only provided in extreme circumstances. 7 7 The Exchange does not believe the type of extreme situation that is covered by the proposed rule would occur in the normal course of trading. Rather, this type of situation could potentially occur as a result of, for example, an error in a member's quotation system that causes a market maker to severely misprice an option. Under the proposed rule, members will have until 8:30 a.m. Eastern Time on the trading day following the trade to notify the Exchange of a potential Catastrophic Error. For trades that take place in an expiring series on the day of expiration, members must notify the Exchange's Market Surveillance Department of a potential Catastrophic Error by 5 p.m. Eastern Time that same day. Once a member has notified Market Surveillance of a potential Catastrophic Error, within the required time period, an Options Exchange Official would review and make a determination as to the claim. 2. Statutory Basis The Exchange believes that the proposed rule change is consistent with section 6(b) of the Act, 8 in general, and furthers the objectives of section 6(b)(5) of the Act, 9 in particular, in that it is designed to promote just and equitable principles of trade, to remove impediments to and perfect the mechanism of a free and open market and a national market system, and, in general to protect investors and the public interest, by helping Exchange members better manage risk through the Catastrophic Error rule. In particular, the proposal would allow members a longer opportunity to seek relief from errors that result in large losses. 8 15 U.S.C. 78f(b). 9 15 U.S.C. 78f(b)(5). B. Self-Regulatory Organization's Statement on Burden on Competition The Exchange does not believe that the proposed rule change would impose any burden on competition that is not necessary or appropriate in furtherance of the purposes of the Act. C. Self-Regulatory Organization's Statement on Comments on the Proposed Rule Change Received From Members, Participants, or Others The Exchange has neither solicited nor received written comments on the proposed rule change. III. Date of Effectiveness of the Proposed Rule Change and Timing for Commission Action Because the proposed rule change does not:

(i)Significantly affect the protection of investors or the public interest;

(ii)impose any significant burden on competition; and

(iii)become operative for 30 days after the date of filing (or such shorter time as the Commission may designate if consistent with the protection of investors and the public interest), the proposed rule change has become effective pursuant to section 19(b)(3)(A) of the Act 10 and subparagraph (f)(6) of Rule 19b-4 thereunder. 11 10 15 U.S.C. 78s(b)(3)(A). 11 17 CFR 240.19b-4(f)(6). A proposed rule change filed under Rule 19b-4(f)(6) normally does not become operative prior to 30 days after the date of filing. 12 However, Rule 19b-4(f)(6)(iii) permits the Commission to designate a shorter time if such action is consistent with the protection of investors and the public interest. The Exchange has requested that the Commission waive the 30-day operative delay and designate the proposed rule change operative upon filing. The Commission believes that waiving the 30-day operative delay is consistent with the protection of investors and the public interest. Given that the Exchange's proposed catastrophic error rule is substantially similar to that of the International Securities Exchange and that of NYSE Arca, 13 the proposal does not appear to present any novel regulatory issues. Therefore, the Commission designates the proposal operative upon filing. 14 12 17 CFR 240.19b-4(f)(6)(iii). The Exchange has satisfied the five-day pre-filing requirement of Rule 19b-4(f)(6)(iii). 13 *See* Securities Exchange Act Release Nos. 57398 (February 28, 2008), 73 FR 12240 (March 6, 2008) (SR-ISE-2007-112) and 57653 (April 11, 2008), 73 FR 20996 (April 17, 2008) (SR-NYSEArca-2008-41). 14 For purposes only of waiving the operative delay of this proposal, the Commission has considered the proposed rule's impact on efficiency, competition, and capital formation. 15 U.S.C. 78c(f). At any time within 60 days of the filing of the proposed rule change, the Commission may summarily abrogate such rule change if it appears to the Commission that such action is necessary or appropriate in the public interest, for the protection of investors, or otherwise in the furtherance of the purposes of the Act. IV. Solicitation of Comments Interested persons are invited to submit written data, views, and arguments concerning the foregoing, including whether the proposed rule change is consistent with the Act. Comments may be submitted by any of the following methods: Electronic Comments • Use the Commission's Internet comment form ( *http://www.sec.gov/rules/sro.shtml* ); or • Send an e-mail to *rule-comments@sec.gov* . Please include File Number SR-Phlx-2008-42 on the subject line. Paper Comments • Send paper comments in triplicate to Secretary, Securities and Exchange Commission, 100 F Street, NE., Washington, DC 20549-1090. All submissions should refer to File Number SR-Phlx-2008-42. This file number should be included on the subject line if e-mail is used. To help the Commission process and review your comments more efficiently, please use only one method. The Commission will post all comments on the Commission's Internet Web site ( *http://www.sec.gov/rules/sro.shtml* ). Copies of the submission, all subsequent amendments, all written statements with respect to the proposed rule change that are filed with the Commission, and all written communications relating to the proposed rule change between the Commission and any person, other than those that may be withheld from the public in accordance with the provisions of 5 U.S.C. 552, will be available for inspection and copying in the Commission's Public Reference Room, 100 F Street, NE., Washington, DC 20549, on official business days between the hours of 10 a.m. and 3 p.m. Copies of such filing also will be available for inspection and copying at the principal office of the Exchange. All comments received will be posted without change; the Commission does not edit personal identifying information from submissions. You should submit only information that you wish to make available publicly. All submissions should refer to File Number SR-Phlx-2008-42 and should be submitted on or before July 18, 2008. 15 17 CFR 200.30-3(a)(12). For the Commission, by the Division of Trading and Markets, pursuant to delegated authority. 15 Florence E. Harmon, Acting Secretary. [FR Doc. E8-14566 Filed 6-26-08; 8:45 am] BILLING CODE 8010-01-P DEPARTMENT OF STATE [Public Notice 6279] Culturally Significant Objects Imported for Exhibition Determinations: “Giorgio Morandi, 1890-1964” SUMMARY: Notice is hereby given of the following determinations: Pursuant to the authority vested in me by the Act of October 19, 1965 (79 Stat. 985; 22 U.S.C. 2459), Executive Order 12047 of March 27, 1978, the Foreign Affairs Reform and Restructuring Act of 1998 (112 Stat. 2681, *et seq.* ; 22 U.S.C. 6501 note, *et seq.* ), Delegation of Authority No. 234 of October 1, 1999, Delegation of Authority No. 236 of October 19, 1999, as amended, and Delegation of Authority No. 257 of April 15, 2003 [68 FR 19875], I hereby determine that the objects to be included in the exhibition “Giorgio Morandi, 1890-1964” to be displayed at The Metropolitan Museum of Art, New York, New York, imported from abroad for temporary exhibition within the United States, are of cultural significance. The objects are imported pursuant to loan agreements with the foreign owners or custodians. I also determine that the exhibition or display of the exhibit objects at The Metropolitan Museum of Art, New York, New York, from on or about September 16, 2008, until on or about December 14, 2008, and at possible additional exhibitions or venues yet to be determined, is in the national interest. Public Notice of these Determinations is ordered to be published in the **Federal Register** . FOR FURTHER INFORMATION CONTACT: For further information, including a list of the exhibit objects, contact Wolodymyr Sulzynsky, Attorney-Adviser, Office of the Legal Adviser, U.S. Department of State ( *telephone:* 202/453-8050). The address is U.S. Department of State, SA-44, 301 4th Street, SW., Room 700, Washington, DC 20547-0001. Dated: June 20, 2008. C. Miller Crouch, Principal Deputy Assistant Secretary for Educational and Cultural Affairs, Department of State. 2 [FR Doc. E8-14637 Filed 6-26-08; 8:45 am] BILLING CODE 4710-05-P DEPARTMENT OF STATE [Public Notice 6278] Culturally Significant Objects Imported for Exhibition Determinations: “Hearst the Collector” SUMMARY: Notice is hereby given of the following determinations: Pursuant to the authority vested in me by the Act of October 19, 1965 (79 Stat. 985; 22 U.S.C. 2459), Executive Order 12047 of March 27, 1978, the Foreign Affairs Reform and Restructuring Act of 1998 (112 Stat. 2681, *et seq.* ; 22 U.S.C. 6501 note, *et seq.* ), Delegation of Authority No. 234 of October 1, 1999, Delegation of Authority No. 236 of October 19, 1999, as amended, and Delegation of Authority No. 257 of April 15, 2003 [68 FR 19875], I hereby determine that the objects to be included in the exhibition “Hearst the Collector”, imported from abroad for temporary exhibition within the United States, are of cultural significance. The objects are imported pursuant to loan agreements with the foreign owners or custodians. I also determine that the exhibition or display of the exhibit objects at the Los Angeles County Museum of Art, Los Angeles, California, from on or about November 9, 2008, until on or about February 1, 2009, and at possible additional exhibitions or venues yet to be determined, is in the national interest. Public Notice of these Determinations is ordered to be published in the **Federal Register** . FOR FURTHER INFORMATION CONTACT: For further information, including a list of the exhibit objects, contact Richard Lahne, Attorney-Adviser, Office of the Legal Adviser, U.S. Department of State ( *telephone:* 202-453-8058). The address is U.S. Department of State, SA-44, 301 4th Street, SW., Room 700, Washington, DC 20547-0001. Dated: June 20, 2008. C. Miller Crouch, Principal Deputy Assistant Secretary for Educational and Cultural Affairs, Department of State. [FR Doc. E8-14636 Filed 6-26-08; 8:45 am] BILLING CODE 4710-05-P DEPARTMENT OF TRANSPORTATION Federal Highway Administration Notice of Final Federal Agency Actions on Proposed Highways in Alaska AGENCY: Federal Highway Administration (FHWA), DOT. ACTION: Notice of Limitation on Claims for Judicial Review of Actions by FHWA. SUMMARY: This notice announces actions taken by the FHWA that are final within the meaning of 23 U.S.C. 139(l)(1). The actions relate to various proposed highway projects in the State of Alaska. Those actions grant approvals for the projects. DATES: By this notice, the FHWA is advising the public of final agency actions subject to 23 U.S.C. 139(l)(1). A claim seeking judicial review of the Federal agency actions on the listed highway project will be barred unless the claim is filed on or before *December 24, 2008.* If the Federal law that authorizes judicial review of a claim provides a time period of less than 180 days for filing such claim, then that shorter time period still applies. FOR FURTHER INFORMATION CONTACT: Mr. Michael E. Vanderhoof, Environmental Coordinator, FHWA Alaska Division, P.O. Box 21648, Juneau, Alaska 99802-1648; office hours 8 a.m.-4 p.m. (AST), phone

(907)586-7418; e-mail *michael.vanderhoof@fhwa.dot.gov.* You may also contact Jerry O. Ruehle, DOT&PF Central Region Environmental Manager, Alaska Department of Transportation and Public Facilities, 4111 Aviation Drive, P.O. Box 196900, Anchorage, Alaska 99519-6900; office hours 7:30 a.m.—5 p.m. (AST), phone

(907)269-0534, e-mail *Jerry_Ruehle@dot.state.ak.us.* SUPPLEMENTARY INFORMATION: Notice is hereby given that the FHWA has taken final agency actions by issuing approvals for the following highway project in the State of Alaska that is listed below. The actions by the Federal agency on the project, and the laws under which such actions were taken, are described in the Environmental Assessment

(EA)and Finding of No Significant Impact (FONSI) issued in connection with the project. The EA, FONSI, and other documents from the FHWA administrative record files for the listed project is available by contacting the FHWA or the State of Alaska Department of Transportation & Public Facilities at the addresses provided above. EA and FONSI documents can be viewed and downloaded from the project Web site at *http://www.dowlingroad.com* or viewed at 4111 Aviation Avenue, Anchorage, Alaska 99519. This notice applies to all FHWA decisions and approvals on the listed project as of the issuance date of this notice and all laws and Executive Orders under which such actions were taken, including but not limited to: 1. *General:* National Environmental Policy Act

(NEPA)[42 U.S.C. 4321-4351]; Federal-Aid Highway Act [23 U.S.C. 109]. 2. *Air:* Clean Air Act, [42 U.S.C. 7401-7671(q)]. 3. *Land:* Section 4(f) of the Department of Transportation Act of 1966 [49 U.S.C. 303]. 4. *Wildlife:* Endangered Species Act of 1973 [16 U.S.C. 1531-1544 and Section 1536]; Anadromous Fish Conservation Act [16 U.S.C. 757(a)-757(g)]; Fish and Wildlife Coordination Act [16 U.S.C. 661-667(d)], Migratory Bird Treaty Act [16 U.S.C. 703-712]; Magnuson-Stevenson Fishery Conservation and Management Act 1976 as amended [16 U.S.C. 1801 *et seq.* ]. 5. *Historic and Cultural Resources:* Section 106 of the National Historic Preservation Act of 1966, as amended [16 U.S.C. 470(f) *et seq.* ]; Archeological Resources Protection Act of 1977 [16 U.S.C. 470(aa)-11]; Archeological and Historic Preservation Act [16 U.S.C. 469-469(c)]. 6. *Social and Economic:* Civil Rights Act of 1964 [42 U.S.C. 2000(d)-2000(d)(1)]; Farmland Protection Policy Act

(FPPA)[7 U.S.C. 4201-4209]. 7. *Wetlands and Water Resources:* Clean Water Act [33 U.S.C. 1251-1377]; Coastal Zone Management Act [16 U.S.C. 1451-1465]; Land and Water Conservation Fund

(LWCF)[16 U.S.C. 4601-4604]; Wild and Scenic Rivers Act [16 U.S.C. 1271-1287]. 8. *Executive Orders:* E.O. 11990 Protection of Wetlands; E.O. 11988 Floodplain Management; E.O. 12898, Federal Actions to Address Environmental Justice in Minority Populations and Low Income Populations; E.O. 13186 Migratory Birds; E.O. 11514 Protection and Enhancement of Environmental Quality. The project subject to this notice is: *Project:* West Dowling Road Connection Project. *Project Location:* Anchorage, Alaska, Municipality of Anchorage, West Dowling Road. Project Reference Number: STP-0532(5) Project type: Road improvements and extension of Dowling Road between Old Seward Highway and Minnesota Drive, a distance of approximately 1.65 miles. The Dowling Road arterial will be extended from B Street to Minnesota Drive and will be widened to 5 lanes between Old Seward Highway and B Street with associated improvements to railroad crossings, traffic control, lighting, drainage, noise barriers, bridges, and trails. These improvements are needed to address current and future connectivity and accessibility needs and to address the need for an east-west arterial between Tudor Road and Dimond Boulevard as outlined in the Anchorage Bowl Long Range Transportation Plan. NEPA document: An EA and FONSI were approved on April 1, 2008, and are available electronically at *http://www.dowlingroad.com.* (Catalog of Federal Domestic Assistance Program Number 20.205, Highway Planning and Construction. The regulations implementing Executive Order 12372 regarding intergovernmental consultation on Federal programs and activities apply to this program.) Authority: 23 U.S.C. 139(l)(1) David C. Miller, Division Administrator, Juneau, Alaska. [FR Doc. E8-13636 Filed 6-26-08; 8:45 am] BILLING CODE 4910-RY-P DEPARTMENT OF TRANSPORTATION Federal Railroad Administration [Docket No. FRA-2008-0009, Notice No. 2] Declaration of Emergency Event AGENCY: Federal Railroad Administration (FRA), DOT. ACTION: Notice of declaration of emergency event. SUMMARY: On June 11, 2008, the Administrator of the FRA determined that the recent flooding around the Midwest region of the United States constituted an emergency event as related to railroad operations. Accordingly, the Administrator activated the Emergency Relief Docket. This document provides notice of the Administrator's determination. SUPPLEMENTARY INFORMATION: On June 11, 2008, the Administrator of the FRA determined that the recent flooding around the Midwest region of the United States constituted an emergency event pursuant to 49 CFR 211.45(c) and that public safety would benefit from providing the railroad industry with operational relief directly related to that emergency. Accordingly, the Administrator activated the Emergency Relief Docket (docket number FRA-2008-0009) and in accordance with 49 CFR 211.45(g), petitions received in that docket pursuant to this emergency event will be handled according to the requirements of 49 CFR 211.45(g)-(j). Interested parties are reminded that the procedures in 49 CFR 211.45 provide for expedited review and processing of emergency waiver petitions. Accordingly, in accordance with 49 CFR 211.45(h), any person wishing to comment on petitions for emergency waivers should submit their comments to the docket within 72 hours from the close of business on the day that the petition is posted in the public docket. Any person desiring a public hearing on any petition being processed in accordance with the emergency waiver procedures must notify FRA of such request in their comments submitted to the docket. 49 CFR 211.45(i). Interested persons may submit their comments using any of the following methods:

(1)E-mail to FRA at *RRS.Correspondence@dot.gov;*

(2)Fax to FRA at: 202-493-6309; or

(3)Hand deliver or expedited delivery to the Docket Clerk, Docket Operations Facility, U.S. Department of Transportation, 1200 New Jersey Avenue, SE., W12-140, Washington, DC 20590 or electronically via the Internet at *http://www.regulations.gov.* All communications concerning any petition in the Emergency Relief Docket should identify the appropriate docket number (e.g., FRA-2008-0009). Privacy Anyone is able to search all comments received into any of our dockets by the name of the individual submitting the comment (or signing the comment, if submitted on behalf of an association, business, labor union, etc.). You may review DOT's complete Privacy Act Statement in the **Federal Register** published on April 11, 2000 (Volume 665, Number 7, Pages 19477-78). The statement may also be found at *http://www.dot.gov/privacy.html* . Issued in Washington, DC, on June 23, 2008. Grady C. Cothen, Jr., Deputy Associate Administrator for Safety Standards and Program Development. [FR Doc. E8-14542 Filed 6-26-08; 8:45 am] BILLING CODE 4910-06-P DEPARTMENT OF TRANSPORTATION Surface Transportation Board [STB Docket No. AB-290 (Sub-No. 290X)] Norfolk Southern Railway Company—Abandonment Exemption—in Lucas County, OH Norfolk Southern Railway Company

(NSR)has filed a verified notice of exemption under 49 CFR 1152 Subpart F— *Exempt Abandonments* to abandon a 2.82-mile line of railroad between milepost TW 0.00 and milepost TW 2.82 in Toledo, Lucas County, OH. 1 The line traverses United States Postal Service Zip Codes 43604, 43607, and 43609. 1 In Docket No. AB-290 (Sub-No. 39X), *Norfolk and Western Railway Company—Discontinuance Exemption—Operations between Toledo and Walbridge Junction, OH,* the Interstate Commerce Commission granted authority for Norfolk and Western Railway Company

(NW)to discontinue its service over the line. In its notice here, however, NSR, as successor to NW by merger, indicates that the portion of its line between milepost TW 2.69 and milepost TW 2.82 shares the right-of-way and a bridge with an active rail line, and NSR states that no salvage or other track removal activities will occur on that segment and that the bridge will be unaffected. NSR has certified that:

(1)No local traffic has moved over the line for at least 2 years;

(2)overhead traffic on the line, if any, has been rerouted over other lines;

(3)no formal complaint filed by a user of rail service on the line (or by a state or local government entity acting on behalf of such user) regarding cessation of service over the line either is pending with the Surface Transportation Board (Board) or with any U.S. District Court or has been decided in favor of complainant within the 2-year period; and

(4)the requirements at 49 CFR 1105.7 (environmental report), 49 CFR 1105.8 (historic report), 49 CFR 1105.11 (transmittal letter), 49 CFR 1105.12 (newspaper publication), and 49 CFR 1152.50(d)(1) (notice to governmental agencies) have been met. As a condition to this exemption, any employee adversely affected by the abandonment shall be protected under *Oregon Short Line R. Co.—Abandonment—Goshen,* 360 I.C.C. 91 (1979). To address whether this condition adequately protects affected employees, a petition for partial revocation under 49 U.S.C. 10502(d) must be filed. Provided no formal expression of intent to file an offer of financial assistance

(OFA)has been received, this exemption will be effective on July 29, 2008, unless stayed pending reconsideration. Petitions to stay that do not involve environmental issues, 2 formal expressions of intent to file an OFA under 49 CFR 1152.27(c)(2), 3 and trail use/rail banking requests under 49 CFR 1152.29 must be filed by July 7, 2008. Petitions to reopen or requests for public use conditions under 49 CFR 1152.28 must be filed by July 17, 2008, 4 with the Surface Transportation Board, 395 E Street, SW., Washington, DC 20423-0001. 2 The Board will grant a stay if an informed decision on environmental issues (whether raised by a party or by the Board's Section of Environmental Analysis

(SEA)in its independent investigation) cannot be made before the exemption's effective date. *See Exemption of Out-of-Service Rail Lines,* 5 I.C.C. 2d 377 (1989). Any request for a stay should be filed as soon as possible so that the Board may take appropriate action before the exemption's effective date. 3 Each OFA must be accompanied by the filing fee, which currently is set at $1,300. *See* 49 CFR 1002.2(f)(25). 4 NSR states that it does not have fee title to the entire right-of-way underlying the line and will not have a contiguous corridor available for public use. A copy of any petition filed with the Board should be sent to NSR's representative: James R. Paschall, Senior General Attorney, Norfolk Southern Corporation, Three Commercial Place, Norfolk, VA 23510. If the verified notice contains false or misleading information, the exemption is void *ab initio.* NSR has filed environmental and historic reports that address the effects, if any, of the abandonment on the environment and historic resources. SEA will issue an environmental assessment

(EA)by July 3, 2008. Interested persons may obtain a copy of the EA by writing to SEA (Room 1100, Surface Transportation Board, Washington, DC 20423-0001) or by calling SEA, at

(202)245-0305. [Assistance for the hearing impaired is available through the Federal Information Relay Service

(FIRS)at 1-800-877-8339.] Comments on environmental and historic preservation matters must be filed within 15 days after the EA becomes available to the public. Environmental, historic preservation, public use, or trail use/rail banking conditions will be imposed, where appropriate, in a subsequent decision. Pursuant to the provisions of 49 CFR 1152.29(e)(2), NSR shall file a notice of consummation with the Board to signify that it has exercised the authority granted and fully abandoned the line. If consummation has not been effected by NSR's filing of a notice of consummation by June 27, 2009, and there are no legal or regulatory barriers to consummation, the authority to abandon will automatically expire. Board decisions and notices are available on our Web site at “ *http://www.stb.dot.gov.* ” Decided: June 23, 2008. By the Board, Joseph H. Dettmar, Acting Director, Office of Proceedings. Anne K. Quinlan, Acting Secretary. [FR Doc. E8-14577 Filed 6-26-08; 8:45 am] BILLING CODE 4915-01-P DEPARTMENT OF TRANSPORTATION Surface Transportation Board [STB Ex Parte No. 677 (Sub-No. 1)] Common Carrier Obligation of Railroads—Transportation of Hazardous Materials AGENCY: Surface Transportation Board. ACTION: Notice of Rescheduled Hearing. SUMMARY: The Surface Transportation Board (Board) hereby gives notice of the rescheduling of its hearing regarding the common carrier obligation of railroads with respect to the transportation of hazardous materials. DATES: The public hearing will take place on Tuesday, July 22, 2008 at 9 a.m.. Any person wishing to speak at the hearing should file with the Board a written notice of intent to participate, and should identify the party, the proposed speaker, and the time requested, as soon as possible but no later than July 10, 2008. Each speaker should also file with the Board his/her written testimony in that same document. Written submissions by interested persons who do not wish to appear at the hearing will also be due by July 10, 2008. FOR FURTHER INFORMATION CONTACT: Timothy Strafford 202-245-0356. [Assistance for the hearing impaired is available through the Federal Information Relay Service

(FIRS)at 1-800-877-8339.] SUPPLEMENTARY INFORMATION: By a decision served on June 4, 2008, the Board announced that it would hold a hearing at 9 a.m. on Wednesday, July 16, 2008, at its headquarters in Washington, DC, for the purpose of examining issues related to the common carrier obligation of railroads with respect to the transportation of hazardous materials. Persons wishing to speak at the hearing were directed to notify the Board in writing and submit their written testimony no later than July 2, 2008. Written testimony from other interested parties was also due by July 2, 2008. In order to address witness availability concerns, the Board served a decision on June 19, 2008, announcing that it would grant a short extension and hold the hearing on Tuesday, July 22, 2008. The hearing will begin at 9 a.m. in the 1st floor hearing room at the Board's headquarters at 395 E Street, SW., in Washington, DC, and will continue, with short breaks if necessary, until every person scheduled to speak has been heard. In light of the Independence Day holiday, the Board announced by decision served June 23, 2008 that it would extend the due date for notices of intent to participate and written testimony by hearing participants, as well as other interested persons who do not wish to appear at the hearing, until July 10, 2008. *Board Releases and Live Video Streaming Available Via the Internet.* Decisions and notices of the Board are available on the Board's Web site at “ *http://www.stb.dot.gov.* ” This hearing will be available on the Board's Web site by live video streaming. To access the hearing, click on the “Live Video” link under “Information Center” at the left side of the home page beginning at 9 a.m. on July 22, 2008. This action will not significantly affect either the quality of the human environment or the conservation of energy resources. Dated: June 23, 2008. By the Board, Anne K. Quinlan, Acting Secretary. Anne K. Quinlan, Acting Secretary. [FR Doc. E8-14574 Filed 6-26-08; 8:45 am] BILLING CODE 4915-01-P DEPARTMENT OF TRANSPORTATION Surface Transportation Board [STB Finance Docket No. 35147 1 ] Norfolk Southern Railway Company, Pan Am Railways, Inc., et al.—Joint Control and Operating/Pooling Agreements—Pan Am Southern, LLC AGENCY: Surface Transportation Board. ACTION: Decision No. 2 in STB Finance Docket No. 35147; Notice of Acceptance of Primary Application and Related Filings; Issuance of Procedural Schedule. SUMMARY: The Surface Transportation Board (Board) is accepting for consideration the primary application and related filings, filed on May 30, 2008, by Norfolk Southern Railway Company (Norfolk Southern), Pan Am Railways, Inc.

(PARI)(a noncarrier railroad holding company), and two of PARI's rail carrier subsidiaries, Boston and Maine Corporation (B&M) and Springfield Terminal Railway Company (Springfield Terminal) (collectively, Applicants). The primary application seeks Board approval under 49 U.S.C. 11322 and 11323 of

(1)the acquisition by Norfolk Southern and B&M of joint control and ownership of Pan Am Southern, LLC (PAS), a new rail carrier to be formed; and

(2)the agreements by which Springfield Terminal would operate the lines of PAS and establish rates for PAS. The agreements for which approval and authorization are being sought by the application and the related filings will be referred to collectively as the Transaction. 1 This decision also embraces *Pan Am Southern, LLC—Acquisition and Operation Exemption—Lines of Boston and Maine Corporation* , STB Finance Docket No. 35147 (Sub-No. 1); *Norfolk Southern Railway Company—Trackage Rights Exemption—Pan Am Southern, LLC—Between Mechanicville, NY and Ayer, MA* , STB Finance Docket No. 35147 (Sub-No. 2); and *Springfield Terminal Railway Company—Trackage Rights Exemption—Pan Am Southern, LLC—Between CPF 312 Near Willows, MA, and Harvard Station, MA* , STB Finance Docket No. 35147 (Sub-No. 3) (collectively, the related filings). If the Transaction is approved, PAS would own or operate over (through trackage rights) approximately 437 miles of track (PAS Lines). The PAS Lines consist of 238.3 miles of rail lines to be owned by PAS, as well as 198.4 miles of track over which PAS would have trackage rights. The west to east main line section of the PAS Line, called the Patriot Corridor, would be comprised of 139.7 miles of track to be owned by PAS extending from Mechanicville, NY to CPF-312, near Ayer, MA, as well as 15.8 miles of trackage rights over Massachusetts Bay Transportation Authority

(MBTA)track between Fitchburg, MA and Willows, MA. The north-south section of the PAS Lines extending from White River Junction, VT to New Haven, CT would be comprised of:

(1)72.8 miles of trackage rights over New England Central Railroad

(NECR)between White River Junction, VT and East Northfield, MA;

(2)49.7 miles of track to be owned by PAS on the Connecticut River Mainline between East Northfield, MA and Springfield, MA; and

(3)62.0 miles of trackage rights over the National Railroad Passenger Corporation (Amtrak) between Springfield, MA and New Haven, CT. The PAS Lines would also include several branch lines. 2 2 The branch lines consist of:

(1)The Rotterdam Branch, which is approximately 30.5 miles between Rotterdam Junction, NY and Mechanicville, NY (including 18.3 miles of trackage over Canadian Pacific Railway Company

(CP)between Mohawk Yard in Schenectady, NY and Mechanicville, NY);

(2)the Adams Industrial branch, which is approximately 4.6 miles between N. Adams, MA and Adams, MA;

(3)the Heywood Industrial branch, which is approximately 1.2 miles between Gardner, MA and Heywood, MA;

(4)approximately 2.3 miles between Ayer, MA and Harvard Station, MA;

(5)the Groton Industrial, which consists of trackage rights over MBTA extending approximately 5 miles between Ayer, MA and Groton, MA;

(6)approximately 2.3 miles of trackage rights over MBTA between Willows, just east of Ayer, MA, and Littleton, MA;

(7)approximately 42.9 miles between Berlin, CT and Derby, CT (including 18.6 miles of trackage rights over Metro North Commuter Railroad

(MNCR)between Waterbury, CT and Derby, CT);

(8)the Southington Industrial branch, which is approximately 4.5 miles between Plainville, CT and Southington, CT; and

(9)approximately 3.7 miles of trackage rights over CSX Transportation, Inc.

(CSXT)between North Haven, CT and Cedar Hill, CT. In addition, the parties have filed with the application three related notices of exemption. Pursuant to 49 CFR 1150.35(a), the first is a notice of intention to file, on or after June 16, 2008, a notice of exemption in *Pan Am Southern, LLC—Acquisition and Operation Exemption—Lines of Boston and Maine Corporation,* STB Finance Docket No. 35147 (Sub-No. 1), for PAS to acquire from B&M the 437 miles of rail lines and trackage rights involved in the Transaction and to operate over the lines as a common carrier. The second is a notice of exemption in *Norfolk Southern Railway Company—Trackage Rights Exemption—Pan Am Southern, LLC—Between Mechanicville, NY and Ayer, MA,* STB Finance Docket No. 35147 (Sub-No. 2), for Norfolk Southern to acquire trackage rights over 151.33 miles of PAS track between Mechanicville, NY and Ayer, MA. Finally, Applicants have included a notice of exemption in *Springfield Terminal Railway Company—Trackage Rights Exemption—Pan Am Southern, LLC—Between CPF 312 Near Willows, MA, and Harvard Station, MA,* STB Finance Docket No. 35141 (Sub-No. 3), for Springfield Terminal to acquire trackage rights over 6.4 miles of PAS track, to allow Springfield Terminal to continue to connect its remaining lines and to preserve connections to CSXT and Providence and Worcester Railroad Company (P&W). In this decision, the Board finds that the Transaction is a “minor transaction” under 49 CFR 1180.2(c). The Board also adopts a procedural schedule for consideration of the application under which the Board's final decision would be issued on October 20, 2008, and become effective on November 4, 2008, assuming that there is no need for further environmental analysis. *See* the discussion on environmental matters, below. DATES: The effective date of this decision is June 27, 2008. Comments on applicants' Environmental Appendix, which sets out why they believe no formal environmental review is warranted in this case, are due to the Board's Section of Environmental Analysis

(SEA)by July 7, 2008. Any person who wishes to participate in this proceeding as a party of record

(POR)must file, no later than July 11, 2008, a notice of intent to participate. All comments, protests, requests for conditions, and any other evidence and argument in opposition to the primary application and related filings, including filings by the U.S. Department of Justice

(DOJ)and the U.S. Department of Transportation (DOT), must be filed by August 11, 2008. Responses to comments, protests, requests for conditions, and other opposition, and rebuttal in support of the primary application or related filings must be filed by September 5, 2008. If a public hearing or oral argument is held, it will be held on a date to be determined by the Board. The Board will issue its final decision on October 20, 2008, unless an extension is needed to permit the completion of formal environmental review. ADDRESSES: Any filing submitted in this proceeding must be submitted either via the Board's e-filing format or in the traditional paper format. Any person using e-filing should attach a document and otherwise comply with the instructions found on the Board's Web site at *www.stb.dot.gov* at the “E-FILING” link. Any person submitting a filing in the traditional paper format should send an original and 10 paper copies of the filing (and also an electronic version) to: Surface Transportation Board, 395 E Street, SW., Washington, DC 20423-0001. In addition, one copy of each filing in this proceeding must be sent (and may be sent by e-mail only if service by e-mail is acceptable to the recipient) to each of the following:

(1)Secretary of Transportation, 1200 New Jersey Avenue, SE., Washington, DC 20590;

(2)Attorney General of the United States, c/o Assistant Attorney General, Antitrust Division, Room 3109, Department of Justice, Washington, DC 20530;

(3)Richard A. Allen (representing Applicants), Zuckert, Scoutt & Rasenberger, LLP, 888 Seventeenth Street, N.W., Suite 700, Washington, DC 20006; and

(4)any other person designated as a POR on the service list notice (as explained below, the service list notice will be issued as soon after July 11, 2008, as practicable). FOR FURTHER INFORMATION CONTACT: Julia M. Farr,

(202)245-0359. [Assistance for the hearing impaired is available through the Federal Information Relay Service

(FIRS)at 1-800-877-8339.] SUPPLEMENTARY INFORMATION: Norfolk Southern is a Class I railroad headquartered in Norfolk, VA. With more than 30,000 employees, it operates approximately 21,000 route miles in 22 states and the District of Columbia. Norfolk Southern is a wholly owned subsidiary of Norfolk Southern Corporation, a publicly held noncarrier holding company. Norfolk Southern provides intermodal rail service to upstate New York, New England and Canada through haulage agreements with CP (including CP subsidiaries) (collectively, CP) and Springfield Terminal. 3 3 CP provides haulage of intermodal traffic to Norfolk Southern over a CP line from Sunbury, PA to Mechanicville, NY, and Springfield Terminal provides haulage of intermodal traffic to Norfolk Southern over its line from Mechanicville to the intermodal terminals in Ayer, MA and Waterville, ME. Springfield Terminal is a Class II rail carrier. Its principal office, and that of its affiliate, B&M, is in Massachusetts. With approximately 700 employees, Springfield Terminal operates some 2,056 route miles in Maine, New Hampshire, Vermont, Massachusetts, New York, and Connecticut. PARI is a noncarrier holding company formerly known as Guilford Transportation Industries, Inc. (GTI). PARI has four wholly owned subsidiaries, including B&M and Springfield Terminal. PARI (then GTI) acquired Maine Central Railroad, Inc.

(MCR)in 1981, and in 1983, it purchased B&M and Springfield Terminal. Springfield Terminal's lines extend from Rotterdam Junction, NY in the west, to Mattawamkeag, ME in the east and, with trackage rights, to New Haven, CT in the south. 4 Springfield Terminal interchanges traffic with 15 other railroads. In addition to interchanges with 11 short lines, Springfield Terminal interchanges with CSXT at Rotterdam Junction, NY, Hartford CT, 5 Holyoke, MA, Barbers, MA, Clinton, MA, and Boston, MA (I and F Junction); with CP at CP's Mohawk Yard in Schenectady, NY, St. Johnsbury, VT, and Wells River, VT; with Norfolk Southern at Mohawk Yard; 6 and with Canadian National Railway Company

(CN)at Danville Junction, ME, and St. John, New Brunswick (via CN haulage rights). The largest source of Springfield Terminal's traffic is the paper industry, for which Springfield Terminal transports inbound chemicals, clay, and pulp, and outbound paper. 4 In 1984, GTI also acquired the Delaware & Hudson Railway Company (D&H). D&H filed for bankruptcy protection in 1988 and is now owned by CP. 5 The Hartford interchange point with CSXT is currently inactive. 6 Norfolk Southern has the right to interchange traffic with Springfield Terminal at Mechanicville, NY, but the interchange now takes place by agreement at CP's Mohawk Yard. Following the Transaction and the construction of the proposed intermodal and automotive facility, to be located on the site of two former rail yards at Mechanicville, NY (Mechanicville Facility), it is anticipated that the interchange between Norfolk Southern and PAS will occur at that proposed facility. CP has consented to the relocation of its mainline and modification of the interchange location, in each case to accommodate the proposed Mechanicville Facility. Norfolk Southern, PARI, B&M and Springfield Terminal entered into a Transaction Agreement dated May 15, 2008, which would require the parties upon closing to establish PAS and to effect various other agreements (Ancillary Agreements), the complete versions of which are attached to the confidential version of the application filed with the Board. The Transaction Agreement is subject to, and would be consummated following, receipt of Board approval and effectiveness of applicable exemptions. The Transaction Agreement requires Norfolk Southern to contribute $137.5 million in cash and demand notes, and to assign a Purchase Option 7 to PAS for which Norfolk Southern would receive a 50% membership interest in PAS. The Transaction Agreement requires the Pan Am parties to contribute a 73.684% undivided interest in the PAS Lines, certain trackage rights, and other related assets to PAS for which B&M would receive a 50% membership interest in PAS, and for PAS to use $47.5 million of its capital to exercise the Purchase Option contributed by Norfolk Southern and purchase the other 26.316% undivided interest in the PAS Lines, certain trackage rights, and other related assets from the Pan Am parties. 7 Norfolk Southern has purchased an option (the Purchase Option) from B&M to purchase a 26.316% undivided interest in the PAS Lines and related assets for $52 million, and PARI has agreed to expend $2.5 million to perform specified track work. The $5 million option price paid by Norfolk Southern is non-refundable but will be credited against the purchase price when PAS exercises the Purchase Option at closing of the Transaction Agreement. The application states that Norfolk Southern would infuse substantial capital into PAS, $87.5 million dollars of which would go into improving infrastructure. PAS would use part of that capital to remove long term slow orders along the Patriot Corridor and add capacity and clearances along that line for better traffic flow. Springfield Terminal would provide the labor associated with these capital projects, to the same extent it would do so under its operation of these lines today under its collective bargaining agreements. According to the application, PAS would use a portion of the capital contributed by Norfolk Southern to create the Mechanicville Facility. The proposed Mechanicville Facility is expected to significantly improve overhead rail operations for intermodal and automotive traffic destined to Ayer, MA. The existing intermodal facility at Ayer also would be improved, and a new automotive facility would be constructed at San Vel near Ayer (San Vel Automotive). According to Applicants, for traffic moving into the Boston area from the west, the Transaction would strengthen the existing Norfolk Southern/Springfield Terminal competitive option to CSXT's single line service because it makes PAS a more efficient competitor. Applicants state that short line and regional railroads in the area—P&W, NECR, and Vermont Railroad, Inc. (VTR)—would not only interchange traffic with PAS, but would also obtain new direct routing opportunities for interchange with Norfolk Southern. According to Applicants, these railroads and their customers would benefit further from the proposed infrastructure improvements. *Passenger Service Impacts.* According to Applicants, there are no passenger trains currently operating or expected to operate over the line segments proposed to be owned by PAS. *Discontinuances/Abandonments.* Applicants state that the Transaction would not entail any abandonments or elimination of any facilities. *Financial Arrangements.* According to Applicants, no new securities would be issued in connection with the Transaction, and Norfolk Southern's contribution to PAS would be funded from available cash and credit facilities. Norfolk Southern does not expect any increase in fixed charges as a result of the Transaction. *Time Schedule for Consummation.* Applicants expect to consummate the Transaction promptly after the effective date of any Board approval of the Transaction. *Public Interest Considerations.* Applicants contend that the Transaction would have no adverse competitive effects and that it would in fact enhance their ability to compete with trucks and with other railroads, most notably, CSXT, which is the only Class I railroad now providing rail service over its own lines to locations in this New England region. In a verified statement attached to the application, the Applicants' outside consultant maintains that:

(1)The Transaction is an end-to-end transaction that would eliminate no competing routes, stations, or services;

(2)no rail customer would be left with reduced competitive rail options as a result of the proposed transaction; and

(3)the Transaction would not have any material adverse effects on connecting short lines, but would in fact benefit these carriers. Applicants maintain that the improvement in their ability to compete would be most significant with respect to intermodal and automotive traffic between Massachusetts, eastern New York, and points west. Today, according to Applicants, CSXT has large intermodal and automotive terminals in eastern New York and Massachusetts and carries a large share of the intermodal and automotive traffic in those areas. 8 Applicants maintain that, with the improvements to the PAS Lines and the new or improved terminals at Ayer, San Vel and Mechanicville, Applicants' ability to expand their intermodal and automotive services into markets now largely dominated by CSXT would be significantly enhanced. 8 According to Applicants, CSXT also leases a large terminal facility from Pan Am in Ayer, MA that is capable of handling automotive traffic, but CSXT has elected not to use it and not to relinquish the lease. B&M would contribute that facility to PAS, but it would not be available for PAS's use until 2017 due to the CSXT lease. Applicants state that, in addition to furthering competition, the Transaction would further the public interest in meeting significant transportation needs. According to Applicants, the principal purpose of the Transaction is to enhance the existing infrastructure of the lines to be acquired by PAS, substantially improving service to rail customers. Infrastructure would be enhanced by:

(1)Upgrading the lines to permit heavier (286,000 pound) rail cars, which are more efficient and economical for the coal-burning electric utilities served by the lines;

(2)the proposed intermodal facility at Mechanicville, which would enable Norfolk Southern to better utilize its existing authority to move more efficient double-stack cars to eastern New York from points west and to move single-stack intermodal trains faster and more efficiently to eastern Massachusetts; and

(3)the proposed automotive facilities at Mechanicville and San Vel, which are intended to improve service to shippers of automobiles to eastern New York and New England. According to Applicants, the investment that Norfolk Southern would make in PAS would benefit not only coal, automotive, and intermodal customers but all Springfield Terminal and Norfolk Southern industrial customers. Applicants state that elimination of the interchange of intermodal traffic at the less efficient Mohawk Yard should improve the movement of all traffic through this area. Applicants also assert that customers that can utilize 286,000 pound rail cars would benefit from the rail and track improvements. Finally, according to Applicants, the capacity that would be added and the increase in the speed of the main line between Albany and Ayer would improve the fluidity, speed, and consistency of shipments for all customers using the services of PAS. The Transaction does not contemplate the elimination of any existing facilities. According to Applicants, the short line and regional railroads that would connect with PAS and their customers, including particularly, VTR, P&W, and NECR, would likewise benefit from the improved service over the PAS Lines resulting from those investments, as well as from the new direct connections with Norfolk Southern. *Environmental Impacts.* Applicants state that their representatives met with representatives of the Board's Section of Environmental Analysis

(SEA)on April 22, 2008, to explain why, in Applicants' view, the Transaction would not have significant environmental impacts and require formal environmental review. At SEA's request and to assist the Board in determining whether a formal environmental review should be conducted, Applicants, on June 6, 2008, filed an Environmental Appendix in support of their position and asked for public comments on it. In their Environmental Appendix, Applicants maintain that the Transaction would not have significant environmental impacts because it would not cause significant changes in railroad operations and that further environmental review is not warranted. *Labor Impacts.* Applicants expect that the Transaction would result in no adverse effect on any of the Applicants' employees. Employees of Springfield Terminal are currently providing all of the rail services over the PAS Lines. The Transaction Agreement and the Railroad Operating Agreement (attached to the application) state that, after consummation of the Transaction, Springfield Terminal would become the contract operator of the PAS Lines, and Springfield Terminal would be required to “act in accordance with its then-current collective bargaining agreements as if the Assets were an integral part of the Springfield Terminal railroad network.” 9 Applicants state that the Capital Facilities and Management Agreement (attached to the application) provides that Springfield Terminal would perform work on any capital contract that its labor agreements would require Springfield Terminal employees to perform under pre-Transaction circumstances unless Springfield Terminal obtains a waiver of any such requirement. Thus, according to Applicants, the same employees would be performing the same work under the same agreements for the foreseeable future. 9 Exhibit E, Section 9(f)(ii)(A). In any event, Applicants expect that, as required by 49 U.S.C. 11326(a), the Board would impose the labor protective conditions set forth in *New York Dock Ry.—Control—Brooklyn Eastern Dist.,* 360 I.C.C. 60, 84-90

(1979)( *New York Dock), aff'd sub nom. New York Dock Ry.* v. *United States,* 609 F.2d 83 (2d Cir. 1979), on the elements of the Transaction that are subject to 49 U.S.C. 11323. *Related Filings.* In connection with the Transaction, three notices of exemption were filed: *(Sub-No. 1).* Pursuant to 49 CFR 1150.35(a), PAS filed a notice of intent to file, on or after June 16, 2008, a notice of exemption docketed as (Sub-No. 1), whereby PAS would acquire and operate certain lines of B&M and acquire incidental trackage rights from Springfield Terminal to operate over the lines of third parties. Pursuant to the primary application to which this notice in (Sub-No. 1) is related, PAS would be formed and Norfolk Southern would contribute cash, demand notes and the Purchase Option agreement to PAS, which together are valued at $140 million. Under the Transaction that is the subject of the notice in (Sub-No. 1), B&M would contribute certain railroad lines in Massachusetts, New York, Vermont, New Hampshire and Connecticut, totaling approximately 238 route miles. Springfield Terminal would assign to PAS trackage rights Springfield Terminal currently holds over certain lines of MBTA, NECR, CP, Amtrak, CSXT, and MNCR, totaling approximately 198 route miles. *(Sub-No. 2).* Pursuant to 49 CFR 1180.2(d)(7) and 1180.4(g), Norfolk Southern filed a notice of exemption to permit it to acquire overhead trackage rights over approximately 151.33 miles of track that would be owned or operated by PAS between Mechanicville, NY and Ayer, MA. According to Norfolk Southern, the trackage rights that are the subject of this notice would enable Norfolk Southern to provide direct rail transportation of intermodal traffic to and from the existing intermodal terminal at Ayer, MA, and the new automotive terminal that the Applicants propose to construct at nearby San Vel, MA, in the event that PAS fails to provide haulage services at a service level required under the Transaction Agreement. Norfolk Southern would not exercise any of the trackage rights until the later of

(1)the effective date of the notice of exemption (including compliance with any conditions imposed on the exemption by the Board) or

(2)the closing of the agreements for which the Board's approval is being sought in the primary application. As a condition to this exemption, Applicants state that any employees affected by the acquisition of these trackage rights would be protected under the conditions imposed in *Norfolk and Western Ry. Co.—Trackage Rights—BN,* 354 I.C.C. 605 (1978), *as modified in Mendocino Coast Ry., Inc.—Lease and Operate,* 360 I.C.C. 653

(1980)*(N&W).* *(Sub No. 3).* Pursuant to 49 CFR 1180.2(d)(7) and 1180.4(g), Springfield Terminal filed a notice of exemption to permit it to acquire overhead trackage rights over approximately 6.4 miles of track that would be owned by PAS between Willows, MA, and Harvard Station, MA. The trackage rights that are the subject of this notice would enable Springfield Terminal to provide direct transportation of traffic for its own account between its current lines east of CPF 312 and its current line south of Harvard Station, MA. These trackage rights also would enable Springfield Terminal to continue to interchange traffic in its own account directly with CSXT and the P&W at points south of Harvard Station. Springfield Terminal would not exercise any of the trackage rights until the later of

(1)the effective date of the notice of exemption (including compliance with any conditions imposed on the exemption by the Board) or

(2)the closing of the agreements for which the Board's approval is being sought in the primary application. As a condition to this exemption, Applicants state than any employees affected by the acquisition of these trackage rights would be protected under the conditions imposed in *N&W.* *Primary Application and Related Filings Accepted.* Based on the information provided in the application, the Board finds the proposed Transaction to be a “minor transaction” under 49 CFR 1180.2(c). A transaction that does not involve two or more Class I railroads is minor if

(1)it would clearly not have anticompetitive effects, or

(2)any anticompetitive effects would clearly be outweighed by the transaction's contribution to the public interest in meeting significant transportation needs. On the face of the application, there does not appear to be a likelihood of any anticompetitive effects resulting from the Transaction. The Norfolk Southern and Pan Am systems are entirely end-to-end, and it appears that no shipper would have fewer competitive rail alternatives as a result of the Transaction. The Transaction also would not appear to have an adverse competitive effect on connecting short line and regional carriers. The Transaction would not impose any interchange restrictions on PAS, and PAS would honor all of the existing interchange contracts with connecting carriers. Eight short lines connect with the Pan Am lines that would become part of the PAS Lines, and none would lose a connecting alternative as a result of the Transaction. Many short lines would simply be served by PAS instead of Pan Am, and some would gain more direct access to Norfolk Southern via PAS. The Board's finding regarding competitive impact is preliminary. The Board will give careful consideration to any claims that the Transaction would have anticompetitive effects that are not apparent from the application itself. The Board accepts the primary application for consideration because it is in substantial compliance with the applicable regulations governing minor transactions. *See* 49 U.S.C. 11321-26; 49 CFR part 1180. The Board is also accepting for consideration the three related filings, which are also in compliance with the applicable regulations. The Board reserves the right to require the filing of supplemental information as necessary to complete the record. *Public Inspection.* The primary application and related filings are available for inspection in the library (Room 131) at the offices of the Surface Transportation Board, 395 E Street, SW., Washington, DC. In addition, the primary application and related filings may be obtained from Mr. Allen (representing Applicants) at the address indicated above. *Procedural Schedule.* The Board has considered Applicants' request for an expedited procedural schedule filed on May 30, 2008, under which the Board would issue its final decision before the statutory deadline of 180 days after the filing of the primary application. The Board is adopting a procedural schedule that is similar to Applicants' proposed schedule, but providing more time for interested parties to file comments. Under the procedural schedule adopted by the Board, comments on the Environmental Appendix are due to be filed by July 7, 2008. Any person who wishes to participate in this proceeding as a POR must file a notice of intent to participate no later than July 11, 2008; all comments, protests, requests for conditions, and any other evidence and argument in opposition to the primary application or related filings, including filings by DOJ and DOT, must be filed by August 11, 2008; and responses to comments, protests, requests for conditions, and other opposition and rebuttal in support of the primary application or related filings must be filed by September 5, 2008. As in past proceedings, DOJ and DOT will be allowed to file, on the response due date (here, September 5, 2008), their comments in response to the comments of other parties, and Applicants will be allowed to file (as quickly as possible thereafter) a response to any such comments filed by DOJ and/or DOT. Under this schedule, a public hearing or oral argument may be held on a date to be determined by the Board. The Board will issue its final decision by October 20, 2008, with an effective date of 15 days after its issuance, assuming that formal environmental review under NEPA is not required. For further information respecting dates, see the attached Appendix. *Notice of Intent To Participate.* Any person who wishes to participate in this proceeding as a POR must file with the Board, no later than July 11, 2008, a notice of intent to participate, accompanied by a certificate of service indicating that the notice has been properly served on the Secretary of Transportation, the Attorney General of the United States, and Mr. Allen (representing Applicants). If a request is made in the notice of intent to participate to have more than one name added to the service list as a POR representing a particular entity, the extra name will be added to the service list as a “Non-Party.” The list will reflect the Board's policy of allowing only one official representative per party to be placed on the service list, as specified in Press Release No. 97-68 dated August 18, 1997, announcing the implementation of the Board's “One Party—One Representative” policy for service lists. Any person designated as a Non-Party will receive copies of Board decisions, orders, and notices but not copies of official filings. Persons seeking to change their status must accompany that request with a written certification that he or she has complied with the service requirements set forth at 49 CFR 1180.4, and any other requirements set forth in this decision. *Service List Notice.* The Board will serve, as soon after July 11, 2008, as practicable, a notice containing the official service list (the service-list notice). Each POR will be required to serve upon all other PORs, within 10 days of the service date of the service-list notice, copies of all filings previously submitted by that party (to the extent such filings have not previously been served upon such other parties). Each POR also will be required to file with the Board, within 10 days of the service date of the service-list notice, a certificate of service indicating that the service required by the preceding sentence has been accomplished. Every filing made by a POR after the service date of the service-list notice must have its own certificate of service indicating that all PORs on the service list have been served with a copy of the filing. Members of the United States Congress

(MOCs)and Governors

(GOVs)are not parties of record and need not be served with copies of filings, unless any Member or Governor has requested to be, and is designated as, a POR. *Comments, Protests, Requests for Conditions, and Other Opposition Evidence and Argument, Including Filings By DOJ and DOT.* All comments, protests, requests for conditions, and any other evidence and argument in opposition to the primary application or related filings, including filings by DOJ and DOT, must be filed by August 11, 2008. Because the Transaction proposed in the application is a minor transaction, no responsive applications will be permitted. *See* 49 CFR 1180.4(d)(1). Protesting parties are advised that, if they seek either the denial of the application or the imposition of conditions upon any approval thereof, on the theory that approval (or approval without conditions) would harm competition and/or their ability to provide essential services, they must present substantial evidence in support of their positions. *See Lamoille Valley R.R. Co.* v. *ICC,* 711 F.2d 295 (DC Cir. 1983). *Responses To Comments, Protests, Requests for Conditions, and Other Opposition; Rebuttal In Support of the Primary Application Or Related Filings.* Responses to comments, protests, requests for conditions, and other opposition submissions, and rebuttal in support of the primary application or related filings must be filed by September 5, 2008. *Public Hearing/Oral Argument.* The Board may hold a public hearing or an oral argument in this proceeding on a date to be determined by the Board. *Discovery.* Discovery may begin immediately. The parties are encouraged to resolve all discovery matters expeditiously and amicably. *Environmental Matters.* Applicants assert in their application that the proposed Transaction would have insignificant environmental effects and therefore does not require a formal environmental review under the National Environmental Policy Act of 1969 (NEPA). Applicants state that the proposed Transaction would result in no significant changes in railroad operations that would exceed the thresholds triggering environmental review established in the Board's environmental rules at 49 CFR 1105.7(e)(4) or (5). No related rail construction or abandonment projects requiring Board approval have been proposed. Applicants further state that the Transaction is exempt under 49 CFR 1105.6(c)(2)(i) from environmental reporting requirements and exempt under 49 CFR 1105.8(b)(1) and

(3)from historic preservation reporting requirements. Applicants also state that the proposed Transaction does not require preparation of a Safety Integration Plan pursuant to 49 CFR 1105.6. To assist SEA in determining whether the Transaction would not have significant environmental impacts and would not require formal environmental review, SEA directed Applicants to prepare an Environmental Appendix providing additional details and explanation, including maps, supporting Applicants' conclusion that the Transaction does not warrant the preparation of formal environmental documentation. Applicants have prepared an Environmental Appendix and issued it for public review and comment to a wide range of appropriate Federal, state, and local agencies, government entities and other interested parties in the project area. The Environmental Appendix is available on the Board's Web site at *www.stb.dot.gov,* under “E-LIBRARY/Filings” (see Filings for June 6, 2008). Applicants also placed notices in major newspapers in potentially affected communities to announce the availability of the Environmental Appendix and the opportunity to file public comments. Comments from all interested parties on the Environmental Appendix are to be postmarked by July 7, 2008. Based on its consideration of all timely comments on the Environmental Appendix and its own independent review of all available environmental information, SEA will recommend to the Board whether there is a need for formal environmental review in this case. The Board will then determine whether to issue a finding of no significant environmental impact, or, alternatively, whether an Environmental Assessment

(EA)or Environmental Impact Statement

(EIS)should be prepared. If an EA or EIS is required to meet the Board's NEPA obligations, the procedural schedule set forth here will be adjusted accordingly. *Comments On Environmental Appendix.* All comments on the Environmental Appendix must be filed by July 7, 2008. Persons wishing to submit written comments on the Environmental Appendix should send:

(1)one signed original to SEA by mail postmarked by July 7, 2008, to Office of the Secretary, Case Control Unit, STB Finance Docket No. 35147, Surface Transportation Board, 395 E Street, SW., Washington, DC 20423; 10 and

(2)one copy to Applicants' attorney, Richard A. Allen. Comments can also be submitted electronically by following the instructions for “e-filing” at the Board's Web site at *www.stb.dot.gov.* Any questions or requests for additional information about the Board's environmental review process can be directed to Ken Blodgett of SEA, at 202-245-0305. 10 In their letter of transmittal, Applicants used the wrong zip code (20024, the zip code for the STB's building location), rather than 20423 (the Board's assigned zip code that follows the agency wherever it is located). *Filing/Service Requirements.* Persons participating in this proceeding may file with the Board and serve on other parties: a notice of intent to participate (due by July 11, 2008); a certificate of service indicating service of prior pleadings on persons designated as PORs on the service-list notice (due by the 10th day after the service date of the service-list notice); any comments, protests, requests for conditions, and any other evidence and argument in opposition to the primary application or related filings (due by August 11, 2008); and any responses to comments, etc., and any rebuttal in support of the primary application or related filings (due by September 5, 2008). *Filing Requirements.* Any document filed in this proceeding must be filed either via the Board's e-filing format or in the traditional paper format as provided for in the Board's rules. Any person using e-filing should attach a document and otherwise comply with the instructions found on the Board's Web site at *www.stb.dot.gov* at the “E-FILING” link. Any person filing a document in the traditional paper format should send an original and 10 paper copies of the document (and also an electronic version) to: Surface Transportation Board, 395 E Street, SW., Washington, DC 20423-0001. *Service Requirements.* One copy of each document filed in this proceeding must be sent to each of the following (any copy may be sent by e-mail only if service by e-mail is acceptable to the recipient):

(1)Secretary of Transportation, 1200 New Jersey Avenue, SE., Washington, DC 20590;

(2)Attorney General of the United States, c/o Assistant Attorney General, Antitrust Division, Room 3109, Department of Justice, Washington, DC 20530;

(3)Richard A. Allen (representing Applicants), Zuckert, Scoutt & Rasenberger, LLP, 888 Seventeenth Street, NW., Suite 700, Washington, DC 20006; and

(4)any other person designated as a POR on the service-list notice. *Service of Decisions, Orders, and Notices.* The Board will serve copies of its decisions, orders, and notices only on those persons who are designated on the official service list as either POR, MOC, GOV, or Non-Party. All other interested persons are encouraged to secure copies of decisions, orders, and notices via the Board's Web site at *www.stb.dot.gov* under “E-LIBRARY/Decisions & Notices.” *Access To Filings.* An interested person does not need to be on the service list to obtain a copy of the primary application or any other filing made in this proceeding. Under the Board's rules, any document filed with the Board (including applications, pleadings, etc.) shall be promptly furnished to interested persons on request, unless subject to a protective order. 49 CFR 1180.4(a)(3). The primary application and other filings in this proceeding will also be available on the Board's Web site at *www.stb.dot.gov* under “E-LIBRARY/Filings.” This action will not significantly affect either the quality of the human environment or the conservation of energy resources. *It is ordered:* 1. The primary application in STB Finance Docket No. 35147 and the related filings in STB Finance Docket No. 35147 (Sub-Nos. 1 through 3) are accepted for consideration. 2. The parties to this proceeding must comply with the procedural schedule adopted by the Board in this proceeding as shown in the Appendix. 3. The parties to this proceeding must comply with the procedural requirements described in this decision. 4. This decision is effective on June 27, 2008. Decided: June 23, 2008. By the Board, Chairman Nottingham, Vice Chairman Mulvey, and Commissioner Buttrey. Vice Chairman Mulvey commented with a separate expression. Anne K. Quinlan, Acting Secretary. Vice Chairman Mulvey, commenting: While I vote today to accept for consideration this transaction as “minor” in accordance with the statutory definition of that type of transaction, I believe the time may have come to redefine what is “minor” and what is “significant.” This transaction involves several hundred miles of rail line in the New England region and affects a number of carriers. It is by no means “minor” as that term is commonly used. Appendix—Procedural Schedule 11 May 30, 2008 Application, related notices of exemption, and motion to establish procedural schedule filed. June 27, 2008 Notice of acceptance of application and notices of exemption to be published in Federal Register . July 7, 2008 Comments on the Environmental Appendix due. July 11, 2008 Notices of intent to participate in the proceeding due. August 11, 2008 Comments, protests, requests for conditions, and supporting evidence, including filings for government agencies, due. September 5, 2008 Responses to comments, protests, and requests for conditions, and rebuttal in support of Application due. TBD Public hearing or oral argument may be held. October 20, 2008 Service of final decision. November 4, 2008 Final decision effective. 11 This schedule will be amended, if necessary, to accommodate formal environmental review, if needed. This schedule would meet the procedural deadlines in 49 U.S.C. 11325(a) and (d). [FR Doc. E8-14633 Filed 6-26-08; 8:45 AM] BILLING CODE 4915-01-P DEPARTMENT OF TRANSPORTATION Surface Transportation Board [STB Finance Docket No. 35149] Mitchell-Rapid City Regional Railroad Authority—Modified Rail Certificate—Between Caputa and Rapid City, SD On June 6, 2008, Mitchell-Rapid City Regional Railroad Authority (MRCRRA) 1 filed a notice for a modified certificate of public convenience and necessity under 49 CFR Part 1150, Subpart C, *Modified Certificate of Public Convenience and Necessity* , to operate a line of railroad between Caputa and Rapid City, SD (Caputa-Rapid City segment), owned by the South Dakota Department of Transportation (SDDOT). The Caputa-Rapid City segment extends from milepost 646.0, near Caputa, to milepost 659.6 in Rapid City, in Pennington County, SD, a distance of approximately 13.6 miles. 1 MRCRRA is a political subdivision of the State of South Dakota. The Caputa-Rapid City segment is part of a larger line of railroad, extending from Mitchell, SD, to Rapid City, that was acquired by the State of South Dakota from the Chicago, Milwaukee, St. Paul & Pacific Railroad Company after the line was approved for abandonment. 2 2 *See Richard B. Olgivie, Trustee of the Property of Chicago, Milwaukee, St. Paul & Pacific Railroad Company—Abandonment—In South Dakota, Iowa and Nebraska* , Docket No. AB-7 (Sub-No. 88) (ICC served May 14, 1980). The State of South Dakota, through SDDOT, leased the Caputa-Rapid City segment to MRCRRA by agreement dated April 7, 2008. The line is currently out of service and requires rehabilitation before rail operations can commence. MRCRRA would provide service in its own name through a third-party contract operator, or by a sublease of the line to a third-party carrier. The rail segment qualifies for a modified certificate of public convenience and necessity. *See Common Carrier Status of States, State Agencies and Instrumentalities and Political Subdivisions* , Finance Docket No. 28990F (ICC served July 16, 1981). MRCRRA states that as of now no subsidy is involved and that there are no preconditions for shippers to meet in order to receive rail service. This notice will be served on the Association of American Railroads (Car Service Division) as agent for all railroads subscribing to the car-service and car-hire agreement: Association of American Railroads, 50 F Street, NW., Washington, DC 20001; and on the American Short Line and Regional Railroad Association: American Short Line and Regional Railroad Association, 50 F Street, NW., Suite 7020, Washington, DC 20001. Board decisions and notices are available on our Web site at *http://www.stb.dot.gov.* Decided: June 23, 2008. By the Board, Joseph H. Dettmar, Acting Director, Office of Proceedings. Anne K. Quinlan, Acting Secretary. [FR Doc. E8-14631 Filed 6-26-08; 8:45 am] BILLING CODE 4915-01-P DEPARTMENT OF THE TREASURY Internal Revenue Service Proposed Collection; Comment Request for Form 730 AGENCY: Internal Revenue Service (IRS), Treasury. ACTION: Notice and request for comments. SUMMARY: The Department of the Treasury, as part of its continuing effort to reduce paperwork and respondent burden, invites the general public and other Federal agencies to take this opportunity to comment on proposed and/or continuing information collections, as required by the Paperwork Reduction Act of 1995, Public Law 104-13 (44 U.S.C. 3506(c)(2)(A)). Currently, the IRS is soliciting comments concerning Form 730, Tax on Wagering. DATES: Written comments should be received on or before August 26, 2008 to be assured of consideration. ADDRESSES: Direct all written comments to Glenn P. Kirkland, Internal Revenue Service, room 6129, 1111 Constitution Avenue NW., Washington, DC 20224. FOR FURTHER INFORMATION CONTACT: Requests for additional information or copies of the form and instructions should be directed to Allan Hopkins, at

(202)622-6665, Internal Revenue Service, Room 6129, 1111 Constitution Avenue, NW., Washington, DC 20224 or through the Internet at *Allan.M.Hopkins@irs.gov.* SUPPLEMENTARY INFORMATION: *Title:* Tax on Wagering. *OMB Number:* 1545-0235. *Form Number:* Form 730. *Abstract:* Form 730 is used to identify taxable wagers under Internal Revenue Code section 4401 and collect the tax monthly. The information is used to determine if persons accepting wagers are correctly reporting the amount of wagers and paying the required tax. *Current Actions:* Form 730 has been reformatted to be scannable. New entry boxes have been added for a daytime telephone number, and to indicate a final return. Lines 4a and 4b each have a new entry to allow for the separate computation of tax amounts for wagers authorized under state law (line 4a) and for all other wagers (line 4b). *Type of Review:* Revision of a currently approved collection. *Affected Public:* Businesses or other for-profit organizations and individuals. *Estimated Number of Respondents:* 102,164. *Estimated Time per Response:* 8 hrs., 25 min. *Estimated Total Annual Burden Hours:* 384,291. The following paragraph applies to all of the collections of information covered by this notice: An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless the collection of information displays a valid OMB control number. Books or records relating to a collection of information must be retained as long as their contents may become material in the administration of any internal revenue law. Generally, tax returns and tax return information are confidential, as required by 26 U.S.C. 6103. *Request for Comments:* Comments submitted in response to this notice will be summarized and/or included in the request for OMB approval. All comments will become a matter of public record. Comments are invited on:

(a)Whether the collection of information is necessary for the proper performance of the functions of the agency, including whether the information shall have practical utility;

(b)the accuracy of the agency's estimate of the burden of the collection of information;

(c)ways to enhance the quality, utility, and clarity of the information to be collected;

(d)ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques or other forms of information technology; and

(e)estimates of capital or start-up costs and costs of operation, maintenance, and purchase of services to provide information. Approved: June 11, 2008. Allan Hopkins, IRS Reports Clearance Officer. [FR Doc. E8-14557 Filed 6-26-08; 8:45 am] BILLING CODE 4830-01-P 73 125 Friday, June 27, 2008 CORRECTIONS Aaron Siegel ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 52 [EPA-R08-OAR-2007-0617; FRL-8570-2] Clean Air Act Approval and Promulgation of Air Quality Implementation Plan Revision for North Dakota; Revisions to the Air Pollution Control Rules and Alternative Monitoring Plan for Mandan Refinery; Delegation of Authority for New Source Performance Standards Correction In rule document E8-11479 beginning on page 30308 in the issue of Tuesday, May 27, 2008 make the following correction: §52.1820 [Corrected] On page 30314, in the table at §52.1820(c) entitled State of North Dakota Regulations, in the first column, in the second entry, in the third line, “m, 33-15-04-” should read “33-15-04-”. [FR Doc. Z8-11479 Filed 6-26-08; 8:45 am] BILLING CODE 1505-01-D Aaron Siegel DEPARTMENT OF THE TREASURY Internal Revenue Service 26 CFR Parts 1 and 301 [TD 9391] RIN 1545-BF85 Source Rules Involving U.S. Possessions and Other Conforming Changes Correction In correction rule document C8-1105 appearing on page 32629 in the issue of Monday, June 9, 2008 make the following correction: §1.937-2 [Corrected] 1. On page 19373, in §1.937-2(k) at *Example 2.* (ii), the equation is being reprinted correctly as set forth below. ER09AP08.000 [FR Doc. C8-1105 Filed 6-26-08; 8:45 am] BILLING CODE 1505-01-D 73 125 Friday, June 27, 2008 Notices Part II Department of Health and Human Services Centers for Medicare & Medicaid Services Medicare and Medicaid Programs; Quarterly Listing of Program Issuances—January Through March 2008; Notice DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Medicare & Medicaid Services [CMS-9046-N] Medicare and Medicaid Programs; Quarterly Listing of Program Issuances—January Through March 2008 AGENCY: Centers for Medicare & Medicaid Services (CMS), HHS. ACTION: Notice. SUMMARY: This notice lists CMS manual instructions, substantive and interpretive regulations, and other **Federal Register** notices that were published from January 2008 through March 2008, relating to the Medicare and Medicaid programs. This notice provides information on national coverage determinations

(NCDs)affecting specific medical and health care services under Medicare. Additionally, this notice identifies certain devices with investigational device exemption

(IDE)numbers approved by the Food and Drug Administration

(FDA)that potentially may be covered under Medicare. This notice also includes listings of all approval numbers from the Office of Management and Budget for collections of information in CMS regulations and a list of Medicare-approved carotid stent facilities. Included in this notice is a list of the American College of Cardiology's National Cardiovascular Data registry sites, active CMS coverage-related guidance documents, and special one-time notices regarding national coverage provisions. Also included in this notice is a list of National Oncologic Positron Emissions Tomography Registry sites, a list of Medicare-approved ventricular assist device (destination therapy) facilities, a list of Medicare-approved lung volume reduction surgery facilities, a list of Medicare-approved clinical trials for fluorodeoxyglucose positron emissions tomography for dementia, and a list of Medicare-approved bariatric surgery facilities. Section 1871(c) of the Social Security Act requires that we publish a list of Medicare issuances in the **Federal Register** at least every 3 months. Although we are not mandated to do so by statute, for the sake of completeness of the listing, and to foster more open and transparent collaboration efforts, we are also including all Medicaid issuances and Medicare and Medicaid substantive and interpretive regulations (proposed and final) published during this 3-month time frame. FOR FURTHER INFORMATION CONTACT: It is possible that an interested party may need specific information and not be able to determine from the listed information whether the issuance or regulation would fulfill that need. Consequently, we are providing contact persons to answer general questions concerning these items. Copies are not available through the contact persons. (See Section III of this notice for how to obtain listed material.) Questions concerning CMS manual instructions in Addendum III may be addressed to Ismael Torres, Office of Strategic Operations and Regulatory Affairs, Centers for Medicare & Medicaid Services, C4-26-05, 7500 Security Boulevard, Baltimore, MD 21244-1850, or you can call

(410)786-1864. Questions concerning regulation documents published in the **Federal Register** in Addendum IV may be addressed to Gwendolyn Johnson, Office of Strategic Operations and Regulatory Affairs, Centers for Medicare & Medicaid Services, C4-14-03, 7500 Security Boulevard, Baltimore, MD 21244-1850, or you can call

(410)786-6954. Questions concerning Medicare NCDs in Addendum V may be addressed to Patricia Brocato-Simons, Office of Clinical Standards and Quality, Centers for Medicare & Medicaid Services, C1-09-06, 7500 Security Boulevard, Baltimore, MD 21244-1850, or you can call

(410)786-0261. Questions concerning FDA-approved Category B IDE numbers listed in Addendum VI may be addressed to John Manlove, Office of Clinical Standards and Quality, Centers for Medicare & Medicaid Services, C1-13-04, 7500 Security Boulevard, Baltimore, MD 21244-1850, or you can call

(410)786-6877. Questions concerning approval numbers for collections of information in Addendum VII may be addressed to Melissa Musotto, Office of Strategic Operations and Regulatory Affairs, Regulations Development and Issuances Group, Centers for Medicare & Medicaid Services, C5-14-03, 7500 Security Boulevard, Baltimore, MD 21244-1850, or you can call

(410)786-6962. Questions concerning Medicare-approved carotid stent facilities in Addendum VIII may be addressed to Sarah J. McClain, Office of Clinical Standards and Quality, Centers for Medicare & Medicaid Services, C1-09-06, 7500 Security Boulevard, Baltimore, MD 21244-1850, or you can call

(410)786-2994. Questions concerning Medicare's recognition of the American College of Cardiology-National Cardiovascular Data Registry sites in Addendum IX may be addressed to JoAnna Baldwin, MS, Office of Clinical Standards and Quality, Centers for Medicare & Medicaid Services, C1-09-06, 7500 Security Boulevard, Baltimore, MD 21244-1850, or you can call

(410)786-7205. Questions concerning Medicare's active coverage-related guidance documents in Addendum X may be addressed to Beverly Lofton, Office of Clinical Standards and Quality, Centers for Medicare & Medicaid Services, C1-09-06, 7500 Security Boulevard, Baltimore, MD 21244-1850, or you can call

(410)786-7136. Questions concerning one-time notices regarding national coverage provisions in Addendum XI may be addressed to Beverly Lofton, Office of Clinical Standards and Quality, Centers for Medicare & Medicaid Services, C1-09-06, 7500 Security Boulevard, Baltimore, MD 21244-1850, or you can call

(410)786-7136. Questions concerning National Oncologic Positron Emission Tomography Registry sites in Addendum XII may be addressed to Stuart Caplan, RN, MAS, Office of Clinical Standards and Quality, Centers for Medicare & Medicaid Services, C1-09-06, 7500 Security Boulevard, Baltimore, MD 21244-1850, or you can call

(410)786-8564. Questions concerning Medicare-approved ventricular assist device (destination therapy) facilities in Addendum XIII may be addressed to JoAnna Baldwin, MS, Office of Clinical Standards and Quality, Centers for Medicare & Medicaid Services, C1-09-06, 7500 Security Boulevard, Baltimore, MD 21244-1850, or you can call

(410)786-7205. Questions concerning Medicare-approved lung volume reduction surgery facilities listed in Addendum XIV may be addressed to JoAnna Baldwin, MS, Office of Clinical Standards and Quality, Centers for Medicare & Medicaid Services, C1-09-06, 7500 Security Boulevard, Baltimore, MD 21244-1850, or you can call

(410)786-7205. Questions concerning Medicare-approved bariatric surgery facilities listed in Addendum XV may be addressed to Kate Tillman, RN, MA, Office of Clinical Standards and Quality, Centers for Medicare & Medicaid Services, C1-09-06, 7500 Security Boulevard, Baltimore, MD 21244-1850, or you can call

(410)786-9252. Questions concerning fluorodeoxyglucose positron emission tomography for dementia trials listed in Addendum XVI may be addressed to Stuart Caplan, RN, MAS, Office of Clinical Standards and Quality, Centers for Medicare & Medicaid Services, C1-09-06, 7500 Security Boulevard, Baltimore, MD 21244-1850, or you can call

(410)786-8564. Questions concerning all other information may be addressed to Gwendolyn Johnson, Office of Strategic Operations and Regulatory Affairs, Regulations Development Group, Centers for Medicare & Medicaid Services, C5-14-03, 7500 Security Boulevard, Baltimore, MD 21244-1850, or you can call

(410)786-6954. SUPPLEMENTARY INFORMATION: I. Program Issuances The Centers for Medicare & Medicaid Services

(CMS)is responsible for administering the Medicare and Medicaid programs. These programs pay for health care and related services for 39 million Medicare beneficiaries and 35 million Medicaid recipients. Administration of the two programs involves

(1)furnishing information to Medicare beneficiaries and Medicaid recipients, health care providers, and the public and

(2)maintaining effective communications with regional offices, State governments, State Medicaid agencies, State survey agencies, various providers of health care, all Medicare contractors that process claims and pay bills, and others. To implement the various statutes on which the programs are based, we issue regulations under the authority granted to the Secretary of the Department of Health and Human Services under sections 1102, 1871, 1902, and related provisions of the Social Security Act (the Act). We also issue various manuals, memoranda, and statements necessary to administer the programs efficiently. Section 1871(c)(1) of the Act requires that we publish a list of all Medicare manual instructions, interpretive rules, statements of policy, and guidelines of general applicability not issued as regulations at least every 3 months in the **Federal Register** . We published our first notice June 9, 1988 (53 FR 21730). Although we are not mandated to do so by statute, for the sake of completeness of the listing of operational and policy statements, and to foster more open and transparent collaboration, we are continuing our practice of including Medicare substantive and interpretive regulations (proposed and final) published during the respective 3-month time frame. II. How To Use the Addenda This notice is organized so that a reader may review the subjects of manual issuances, memoranda, substantive and interpretive regulations, NCDs, and FDA-approved IDEs published during the subject quarter to determine whether any are of particular interest. We expect this notice to be used in concert with previously published notices. Those unfamiliar with a description of our Medicare manuals may wish to review Table I of our first three notices (53 FR 21730, 53 FR 36891, and 53 FR 50577) published in 1988, and the notice published March 31, 1993 (58 FR 16837). Those desiring information on the Medicare NCD Manual (NCDM, formerly the Medicare Coverage Issues Manual (CIM)) may wish to review the August 21, 1989, publication (54 FR 34555). Those interested in the revised process used in making NCDs under the Medicare program may review the September 26, 2003, publication (68 FR 55634). To aid the reader, we have organized and divided this current listing into 11 addenda: • Addendum I lists the publication dates of the most recent quarterly listings of program issuances. • Addendum II identifies previous **Federal Register** documents that contain a description of all previously published CMS Medicare and Medicaid manuals and memoranda. • Addendum III lists a unique CMS transmittal number for each instruction in our manuals or Program Memoranda and its subject matter. A transmittal may consist of a single or multiple instruction(s). Often, it is necessary to use information in a transmittal in conjunction with information currently in the manuals. • Addendum IV lists all substantive and interpretive Medicare and Medicaid regulations and general notices published in the **Federal Register** during the quarter covered by this notice. For each item, we list the— ○ Date published; ○ **Federal Register** citation; ○ Parts of the Code of Federal Regulations

(CFR)that have changed (if applicable); ○ Agency file code number; and ○ Title of the regulation. • Addendum V includes completed NCDs, or reconsiderations of completed NCDs, from the quarter covered by this notice. Completed decisions are identified by the section of the NCDM in which the decision appears, the title, the date the publication was issued, and the effective date of the decision. • Addendum VI includes listings of the FDA-approved IDE categorizations, using the IDE numbers the FDA assigns. The listings are organized according to the categories to which the device numbers are assigned (that is, Category A or Category B), and identified by the IDE number. • Addendum VII includes listings of all approval numbers from the Office of Management and Budget

(OMB)for collections of information in CMS regulations in title 42; title 45, subchapter C; and title 20 of the CFR. • Addendum VIII includes listings of Medicare-approved carotid stent facilities. All facilities listed meet CMS standards for performing carotid artery stenting for high risk patients. • Addendum IX includes a list of the American College of Cardiology's National Cardiovascular Data registry sites. We cover implantable cardioverter defibrillators

(ICDs)for certain indications, as long as information about the procedures is reported to a central registry. • Addendum X includes a list of active CMS guidance documents. As required by section 731 of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003

(MMA)(Pub. L. 108-173, enacted on December 8, 2003), we will begin listing the current versions of our guidance documents in each quarterly listings notice. • Addendum XI includes a list of special one-time notices regarding national coverage provisions. We are publishing a list of issues that require public notification, such as a particular clinical trial or research study that qualifies for Medicare coverage. • Addendum XII includes a listing of National Oncologic Positron Emission Tomography Registry

(NOPR)sites. We cover positron emission tomography

(PET)scans for particular oncologic indications when they are performed in a facility that participates in the NOPR. • Addendum XIII includes a listing of Medicare-approved facitilites that receive coverage for ventricular assist devices used as destination therapy. All facilities were required to meet our standards in order to receive coverage for ventricular assist devices implanted as destination therapy. • Addendum XIV includes a listing of Medicare-approved facilities that are eligible to receive coverage for lung volume reduction surgery. Until May 17, 2007, facilities that participated in the National Emphysema Treatment Trial are also eligible to receive coverage. • Addendum XV includes a listing of Medicare-approved facilities that meet minimum standards for facilities modeled in part on professional society statements on competency. All facilities must meet our standards in order to receive coverage for bariatric surgery procedures. • Addendum XVI includes a listing of Medicare-approved clinical trials for fluorodeoxyglucose positron emission tomography (FDG-PET) for dementia and neurodegenerative diseases. III. How To Obtain Listed Material A. Manuals Those wishing to subscribe to program manuals should contact either the Government Printing Office

(GPO)or the National Technical Information Service

(NTIS)at the following addresses: Superintendent of Documents, Government Printing Office, ATTN: New Orders, P.O. Box 371954, Pittsburgh, PA 15250-7954, Telephone

(202)512-1800, Fax number

(202)512-2250 (for credit card orders); or National Technical Information Service, Department of Commerce,5825 Port Royal Road, Springfield, VA 22161,Telephone

(703)487-4630. In addition, individual manual transmittals and Program Memoranda listed in this notice can be purchased from NTIS. Interested parties should identify the transmittal(s) they want. GPO or NTIS can give complete details on how to obtain the publications they sell. Additionally, most manuals are available at the following Internet address: *http://cms.hhs.gov/manuals/default.asp.* B. Regulations and Notices Regulations and notices are published in the daily **Federal Register** . Interested individuals may purchase individual copies or subscribe to the **Federal Register** by contacting the GPO at the address given above. When ordering individual copies, it is necessary to cite either the date of publication or the volume number and page number. The **Federal Register** is also available on 24x microfiche and as an online database through GPO Access. The online database is updated by 6 a.m. each day the **Federal Register** is published. The database includes both text and graphics from Volume 59, Number 1 (January 2, 1994) forward. Free public access is available on a Wide Area Information Server

(WAIS)through the Internet and via asynchronous dial-in. Internet users can access the database by using the World Wide Web; the Superintendent of Documents home page address is *http://www.gpoaccess.gov/fr/index.html,* by using local WAIS client software, or by telnet to swais.gpoaccess.gov, then log in as guest (no password required). Dial-in users should use communications software and modem to call

(202)512-1661; type swais, then log in as guest (no password required). C. Rulings We publish rulings on an infrequent basis. CMS Rulings are decisions of the Administrator that serve as precedent final opinions and orders and statements of policy and interpretation. They provide clarification and interpretation of complex or ambiguous provisions of the law or regulations relating to Medicare, Medicaid, Utilization and Quality Control Peer Review, private health insurance, and related matters. Interested individuals can obtain copies from the nearest CMS Regional Office or review them at the nearest regional depository library. We have, on occasion, published rulings in the **Federal Register** . Rulings, beginning with those released in 1995, are available online, through the CMS Home Page. The Internet address is *http://cms.hhs.gov/rulings.* D. CMS' Compact Disk-Read Only Memory (CD-ROM) Our laws, regulations, and manuals are also available on CD-ROM and may be purchased from GPO or NTIS on a subscription or single copy basis. The Superintendent of Documents list ID is HCLRM, and the stock number is 717-139-00000-3. The following material is on the CD-ROM disk: • Titles XI, XVIII, and XIX of the Act. • CMS-related regulations. • CMS manuals and monthly revisions. • CMS program memoranda. The titles of the Compilation of the Social Security Laws are current as of January 1, 2005. (Updated titles of the Social Security Laws are available on the Internet at *http://www.ssa.gov/OP_Home/ssact/comp-toc.htm* .) The remaining portions of CD-ROM are updated on a monthly basis. Because of complaints about the unreadability of the Appendices (Interpretive Guidelines) in the State Operations Manual (SOM), as of March 1995, we deleted these appendices from CD-ROM. We intend to re-visit this issue in the near future and, with the aid of newer technology, we may again be able to include the appendices on CD-ROM. Any cost report forms incorporated in the manuals are included on the CD-ROM disk as LOTUS files. LOTUS software is needed to view the reports once the files have been copied to a personal computer disk. IV. How To Review Listed Material Transmittals or Program Memoranda can be reviewed at a local Federal Depository Library (FDL). Under the FDL program, government publications are sent to approximately 1,400 designated libraries throughout the United States. Some FDLs may have arrangements to transfer material to a local library not designated as an FDL. Contact any library to locate the nearest FDL. In addition, individuals may contact regional depository libraries that receive and retain at least one copy of most Federal Government publications, either in printed or microfilm form, for use by the general public. These libraries provide reference services and interlibrary loans; however, they are not sales outlets. Individuals may obtain information about the location of the nearest regional depository library from any library. For each CMS publication listed in Addendum III, CMS publication and transmittal numbers are shown. To help FDLs locate the materials, use the CMS publication and transmittal numbers. For example, to find the Medicare Benefit Policy publication titled “Erythropoiesis Stimulating Agents in Cancer and Related Neoplastic Conditions,” use CMS-Pub. 100-03, Transmittal No. 80. (Catalog of Federal Domestic Assistance Program No. 93.773, Medicare—Hospital Insurance, Program No. 93.774, Medicare—Supplementary Medical Insurance Program, and Program No. 93.714, Medical Assistance Program) Dated: June 4, 2008. Jacquelyn Y. White, Director, Office of Strategic Operations and Regulatory Affairs. Addendum I This addendum lists the publication dates of the most recent quarterly listings of program issuances. March 24, 2006 (71 FR 14903) June 23, 2006 (71 FR 36101) September 29, 2006 (71 FR 57604) December 22, 2006 (71 FR 77202) March 30, 2007 (72 FR 15282) June 22, 2007 (72 FR 34508) September 28, 2007 (72 FR 55282) December 28, 2007 (72 FR 73990) April 1, 2008 (73 FR 17422) Addendum II—Description of Manuals, Memoranda, and CMS Rulings An extensive descriptive listing of Medicare manuals and memoranda was published on June 9, 1988, at 53 FR 21730 and supplemented on September 22, 1988, at 53 FR 36891 and December 16, 1988, at 53 FR 50577. Also, a complete description of the former CIM (now the NCDM) was published on August 21, 1989, at 54 FR 34555. A brief description of the various Medicaid manuals and memoranda that we maintain was published on October 16, 1992, at 57 FR 47468. Addendum III.—Medicare and Medicaid Manual Instructions January Through March 2008 Transmittal No. Manual/Subject/Publication No. Medicare General Information (CMS-Pub. 100-01) 00 None. Medicare Benefit Policy (CMS-Pub. 100-02) 80 Requirements for Ordering and Following Orders for Diagnostic Tests Clinical Laboratory Services; Requirements for Ordering and Following Orders for Diagnostic Tests Definitions; Interpreting Physician Determines a Different Diagnostic Test is Appropriate; Rules for Testing Facility to Furnish Additional Tests; Rules for Testing Facility Interpreting Physician to Furnish Different or Additional Tests; Surgical/Cytopathology Exception. 81 Process for Amending the List of Compendia for Determination of Medically-Accepted Indications for Off-Label Uses of Drugs and Biologicals in an Anti-Cancer Chemotherapeutic Regimen. 82 January 2008 Update of the Hospital Outpatient Prospective Payment System; Manualization; Outpatient Hospital Services; Limitations on Coverage of Certain Services Furnished to Hospital Outpatients; General Rule; Exception to Limitation; Outpatient Defined; Encounter Defined; Diagnostic Services Defined; Coverage of Outpatient Diagnostic Services; Outpatient Diagnostic Services Under Arrangements; Diagnostic Services Defined; Coverage of Outpatient Diagnostic Services; Outpatient Diagnostic Services Under Arrangements; Outpatient Therapeutic Services; Diagnostic Service Defined; Coverage of Outpatient Diagnostic Services; Outpatient Diagnostic Services Under Arrangements; Outpatient Therapeutic Services; Coverage of Outpatient Therapeutic Services Incident to a Physicians Service; Furnished on or After August 1, 2000; Outpatient Observation Services; Laboratory Services Furnished to Nonhospital Patients by Hospital Laboratory. 83 Clinical Lab: New Automated Test for the AMCC Panel Payment Algorithm Automated Multi-Channel Chemistry Tests. 84 Update to Audiology Policies; Audiological Diagnostic Testing; Definition of Qualified Audiologist. 85 Psychological and Neuropsychological Tests. Medicare National Coverage Determination (CMS-Pub. 100-03) 80 Erythropoiesis Stimulating Agents in Cancer and Related Neoplastic Conditions. Medicare Claims Processing (CMS-Pub. 100-04) 1405 SUBJECT: Reprocessing of Certain Hospital Inpatient Prospective Payment System Claims. 1406 January 2008 Quarterly Average Sales Price Medicare Part B Drug Pricing Files and Revisions to Prior Quarterly Pricing Files. 1407 Outpatient Therapy Caps Without KX Modifier Exceptions Start January 1, 2008 The Financial Limitation. 1408 Modification to the Model Medicare Redetermination Notice (for Partly or Fully Unfavorable Redeterminations); Medicare Redetermination Notice (for Partly or Fully Unfavorable Redeterminations). 1409 Correction to Pub. 100-04, Chapter 17, Section 100.2.1; CAP Required Modifiers. 1410 Annual Type of Service Update. 1411 April 2008 Update to the Medicare Code Editor and Group. 1412 Reporting of Hematocrit or Hemoglobin Levels on All Claims for the Administration of Erythropoiesis Stimulating Agents Implementation of New Modifiers for Non-ESRD Indications, and Reporting of Hematocrit/Hemoglobin Levels on all Non-ESRD, Non-ESA Claims Requesting Payment for Anti-Anemia Drugs; Epoetin Alfa

(EPO)Provided in the Hospital Outpatient Department; Payment for Aranesp in the Hospital Outpatient Department; Reporting of Hematocrit and/or Hemoglobin Levels; Required Modifiers for ESAs As Administered to Non-ESRD Patients; Hospitals Billing for EPO and Darbepoetin Alfa (Aranesp) for Non-ESRD Patients; The Competitive Acquisition Program for Drugs and Biologicals Not Paid on a Cost or Prospective Payments Basis; Claims Processing Instructions for CAP Claims for the Local Carriers; Items 14-33 Provider of Service or Supplier Information. 1413 Erythropoiesis Stimulating Agents in Cancer and Related Neoplastic Conditions; Claims Processing Rules for ESAs Administered to Cancer Patients for Anti-Anemia Therapy. 1414 Outpatient Therapy Caps without KX Modifier Exceptions Start January 1, 2008 The Financial Limitation. 1415 Additional Payable “C” Drug Codes for January 1, 2008 in ASCs. 1416 Clarification of Bone Mass Measurement Billing Requirements; Bone Mass Measurements; Payment Methodology and Healthcare Common Procedure Coding Systems (HCPCS) Coding. 1417 January 2008 Update of the Hospital Outpatient Prospective Payment System. 1418 New Healthcare Common Procedure Coding System Modifiers when Billing for Patient Care in Clinical Research Studies; Carrier Specific Requirements for Certain Specialties/Services; Billing Requirements for Providers Billing Routine Costs of Clinical Trials; Involving a Category A Investigation Device Exemptions; Billing Requirements for Providers Billing Routine Costs of Clinical Trials; Involving a Category B Investigation Device Exemptions; Billing Requirements for Clinical Trials; Reserved for Future Use. 1419 January 2008 Integrated Outpatient Code Specifications Version 9.0. 1420 Clarification Regarding the Coordination of Benefits Agreement; Medigap Claim-Based Crossover Process; Supplemental Coverage/Medigap; COB Training Partner and Medigap Plan Crossover Claim Requirements; Patient and Insured Information; MSN Messages; Coordination of Benefits Agreement Medigap Claim-Based Crossover Process. 1421 Update of Institutional Claims References; Billing Form as Request for Payment; Beneficiary Request for Payment on Provider Record—UB-92 and Electronic Billing (Part A and Part B); When an Inpatient Admission May Be Changed to Outpatient Status; Noncovered Charges on Outpatient Bills; Line-Item Modifiers Related to Reporting of Noncovered Charges When Covered and Noncovered Services Are on the Same Institutional Claim; Form Prescribed by CMS In Accordance with CMS Instructions; Handling Incomplete or Invalid Submissions; Payment Floor Standards; Data Element Requirements Matrix; Claim Change Reason Codes; Inpatient Part A Hospital Adjustment Bills; (previously 130.3.1.2)—Tolerance Guides for Submitting SNF Inpatient Adjustment Request; (previously 130.3.3)—SNF Inpatient Claim Adjustment Instructions; (previously 130.3.4)—Patient Does Not Return From SNF Leave of Absence, and Last Bill Reported Patient Status as Still Patient (30); Billing and Claims Processing Requirements Related to HINNs; Billing and Claims Processing Requirements Related to Expedited Determinations; Source of Admission—Outpatient Hospital; Forms; DRG Grouper Program; Payment to Hospitals and Units Excluded from IPPS for Direct Graduate; Medical Education and Nursing and Allied Health (NandAH); Education for Medicare Advantage Enrollees; Adjustment Bills; Billing Requirements Under IRF PPS; Shared Systems and CWF Edits; System Edits; Benefits Exhausted; Completion of the Uniform (Institutional Provider) Bill (Form CMS-1450); Notice of Election for RNHCI; Required Data Elements on Claims for RNHCI Services; IPF PPS System Edits; Where to Report Modifiers on the UB-92 (Form CMS-1450) and ANSI X12N Formats; Optional Method for Outpatient Services: Cost-Based Facility Services Plus 115; Percent Fee Schedule Payment for Professional Services; Bill Review for Partial Hospitalization Services Provided in Community Mental Health Centers; Line Item Date of Service Reporting for Partial Hospitalization; Line Item Date of Service Reporting on Form CMS-1450; Off-Site CORF Services; Notifying Patient of Service Denial; Billing Skilled Nursing Facility PPS Service; Input/Output Record Layout; Leave of Absence; Services in Excess of Covered Services; Billing Formats; Billing; Calculation of Case Mix Adjusted Composite Rate; In-Facility Dialysis Bill Processing Procedures; Required Information for In-Facility Claims Paid Under the Composite Rate; EPO Facility Billing Requirements; Aranesp Facility Billing Requirements; General Intermediary Bill Processing Procedures for Method I Home Dialysis Services; Required Billing Information for Method I Claims; Billable Revenue Codes Under Method II; Unbillable Revenue Codes Under Method II; General Billing Requirements; General Guidelines for Processing Home Health Agency Claims; Special Billing Situations Involving OASIS Assessment; Heathcare Common Procedure Coding System Coding Requirements; Payment Methodology and HCPCS Coding; General Billing Guidelines—Intermediaries and Carriers; Intermediary Guidelines; Hospital Billing Under Part B; Billing and Payment Instructions for Fiscal Intermediaries (FIs); Requirements for Billing FIs for Immunosuppressive Drugs; Claims Submitted to FIs for Mass Immunizations of Influenza and Pneumococcal Pneumonia Vaccine; Healthcare Common Procedure Coding System and Diagnosis Codes for Mammography Services Diagnoses Codes; HHA Recertification for Home Oxygen Therapy; Billing/Claim Formats; ICD-9-CM Diagnosis and Procedure Codes; Billing Requirements for HBO Therapy for the Treatment of Diabetic Wounds of the Lower Extremities; Billing Requirements for Providers Billing Category B IDEs. 1423 Summary of Policies in the 2008 Medicare Physician Fee Schedule and the Telehealth Originating Site Facility Fee Payment Amount. 1424 Correction to Low Utilization Payment Adjustment Add-on Payments Under the Refined Home Health Prospective Payment System; Composition of Health Insurance Prospect Payment System Codes for Home Health Prospective Payment System; Request for Anticipated Payment; Home Health Prospective Payment System Claims; Input/Output Record Layout; Decision Logic Used by the Pricer on RAPs; Decision Logic Used by the Pricer on Claims; Special Billing Situations Involving OASIS Assessments; Temporary Suspension of Home Health Services. 1425 Medicare Part A Skilled Nursing Facility Prospective Payment System Pricer; Update FY 2008 for 2 Core-Based Statistical Areas with New Wage Index; Values—Correction. 1426 Announcement of Medicare Rural Health Clinics and Federally Qualified Health Centers Payment Rate Increases; Payment Rate for Independent and Provider Based Rural Health Clinics and Federally Qualified Health Clinics. 1427 New Value Code to Report Patient Prior Payments. 1428 Issued to a specific audience, not posted Internet/Intranet due to Confidentiality of Instruction. 1429 Modification of Payment Window Edits in the Common Working File to Look at Line Item Dates of Service on Outpatient Claims; Outpatient Services Treated as Inpatient Services. 1430 Use of HCPCS V2787 When Billing Approved Astigmatism-Correcting; Intraocular Lens in Ambulatory Surgery Centers Physician Offices, and Hospital Outpatient Departments; Payment for Services and Supplies; Coding and General Billing Requirements. 1431 Update to the Implementation Date for Home Health Agencies Providing Durable Medical Equipment in Competitive Bidding Areas; General Guidelines for Processing Home Health Agency Claims; Home Health Prospective Payment System Consolidated Billing. 1432 Medicare Fee-for-Service Legacy Provider IDs Prohibited on Form CMS-1500 and Form CMS-1450 (UB-04) Claims; Carrier Data Element Requirements; Item 14-3 Provider of Service or Supplier Information. 1433 Smoking and Tobacco Use Cessation Counseling BILLING CODE Update; Health Common Procedure Coding System and Diagnosis Coding; Carrier Billing Requirements; FI Billing Requirements. 1434 Extension of the Dates of Service Eligible for the Physician Scarcity Area; Bonus Payment; Billing and Payment in a Physician Scarcity Area; ZIP Code Files; Billing and Payment in a Physician Scarcity Area; Identifying Physician Scarcity Area Locations. 1435 Emergency Update to the 2008 Medicare Physician Fee Schedule Database. 1436 Modifications to the National Coordination of Benefits Agreement; Crossover Process; Consolidated Claims Crossover Process; Consolidation of the Claims Crossover Process; Coordination of Benefits Agreement; Detailed Error Report Notification Process. 1437 Change in the Amount in Controversy Requirement for Administrative Law; Judge Hearings and Federal District Court Appeals; Right to an ALJ Hearing; Requests for U.S. District Court Review by a Party. 1438 Issued to a specific audience, not posted to Internet/Intranet due to Confidentiality of Instruction. 1439 Removal of Outdated References to Christian Science Sanatoria from Medicare Systems. 1440 Medicare, Medicaid, and State Children's Health Insurance Program Extension Act of 2007 Changes to Independent Laboratory Billing for the Technical Component of Physician Pathology Services; Technical Component of Physician Pathology; Hospital Patients. 1441 New “K” Code for Replacement Interface Material. 1442 Issued to a specific audience, not posted to Internet/Intranet due to Confidentiality of Instruction. 1443 Home Health Prospective Payment System Refinement and Rate; Update for Calendar Year 2008; Basis of Medicare Prospective Payment Systems and Case-Mix. 1444 Modification to Existing Medicare Summary Notice Procedures; Regarding the MSN Customer Service Information Box, Beneficiary Estate Information and the Appeals Address; Title Section of the MSN Appeals Section; Title Section. 1445 January 2008 Update of the Hospital Outpatient Prospective Payment System; Manualization; Payment Status Indicators; APC Payment Groups; Composite APCs; Calculation of APC Payment Rates; Packaging; Combinations of Packaged Services of Different Types That Are Furnished on the Same Date of Service; Discounting; Payment Adjustments; Outlier Adjustments; Calculation of Overall Cost to Charge Ratios for Hospitals; Paid Under the Outpatient Prospective Payment System and Community Mental Health Centers Paid Under the Hospital; Requirement to Calculate CCRs for Hospitals Paid Under OPPS and for CMHC Circumstances in Which CCRs Are Used; Selection of the CCR To Be Used; Mergers, Acquisitions, and Other Ownership Changes; New Providers and Providers with Cost Report Periods Less Than a Full Year; Substitution of Statewide CCRs for Extreme OPPS Hospital Specific CCRs; Methodology for Calculation of Hospital Overall CCR for Hospitals That Do Not Have Nursing and Paramedical Education Programs; Methodology for Calculation of Hospital Overall CCR for Hospitals That Have Nursing and Paramedical Education Programs; Methodology for Calculation of CCR for CMHCs; Location of Statewide CCRs, Tolerances for Use of Statewide CCRs in Lieu of Calculated CCRs, and Cost Centers To Be Used in the Calculation of CCRs; Reporting of CCRs for Hospitals Paid Under OPPS and for CMHCs; Packaged Revenue Codes; Revenue Codes for “Sometimes Therapy” Services; Use of Modifiers for Discontinued Services; OPPS Coinsurance; Outpatient Pricer; Outpatient Provider Specific File; Changes to the OPPS Pricer Logic Effective January 1, 2003; Billing for Devices Under the OPPS; Billing and Payment for Brachytherapy Sources; Billing for Brachytherapy Sources—General; Definition of Brachytherapy Source for Separate Payment; Billing of Brachytherapy Sources Ordered for a Specific Patient; Billing for Brachytherapy Source Supervision, Handling, and Loading Costs; Transitional Outpatient Payments for CY 2006-CY 2008; Clinic and Emergency Visits; Critical Care Services; Special Services for OPPS Billing; Billing for Corneal Tissue; Hospital Services For Patients with End-Stage Renal Disease; Billing Codes for Intensity Modulated Radiation Therapy and Stereotactic; Billing for IMRT Planning and Delivery; Additional Billing Instructions for IMRT Planning; Billing for Multi-Source Photon (Cobalt 60-Based) Stereotactic Radiosurgery; Planning and Delivery; Billing for Linear Accelerator (Robotic Image-Guided and Non-Robotic Image-Guided) SRS Planning and Delivery; Billing for Amniotic Membrane; Billing and Payment for Cardiac Rehabilitation Services; Billing and Payment for Alcohol and/or Substance Abuse Assessment and Intervention Services; Billing for Cardiac Echocardiography Services; Cardiac Echocardiography Without Contrast; Cardiac Echocardiography With Contrast; Billing for Nuclear Medicine Procedures; Coding and Payment for Drugs, Biologicals, and Radiopharmaceuticals; Coding and Payment for Drug Administration; Observation Services Overview; Reporting Hours of Observation; Billing and Payment for Observation Services Furnished Between January 1, 2006 and December 31, 2007; Billing and Payment for All Hospital Observation Services Furnished Between January 1, 2006 and December 31, 2007; Separate and Packaged Payment for Direct Admission to Observation Between January 1, 2006 and December 31, 2007; Separate and Packaged Payment for Observation Services Furnished Between January 1, 2006 and December 31, 2007; Billing and Payment for Observation Services Furnished on or After January 1, 2008; Billing and Payment for Observation Services Beginning January 1, 2008; Billing and Payment for Direct Admission to Observation Care Beginning January 1, 2008; Services Not Covered as Observation Services; Hospital Billing Under Part B; Payment Rules for Drugs and Biologicals; Drugs, Biologicals, and Radiopharmaceuticals. 1446 Update to Common Working File (CWF Edits) 7284 and 7548; Indian Health Service/Tribal Hospital Inpatient Social Admits; FI—Social Admissions. 1447 Reporting of Additional Data To Describe Services on Hospice Claims; Levels of Care; Data Required on Claim to FI. 1448 Adjudicating Claims for Immunosuppressive Drugs When Medicare Did Not Pay for the Original Transplant; Billing for Immunosuppressive Drugs. 1450 Update to the Common Working File to Allow the Posting of Skilled Nursing Facility and Swing Bed Claims to the Beneficiary's Spell of Illness When Qualifying Stay Criteria Are Not Met; Billing When Qualifying Stay or Transfer Criteria Are Not Met. 1451 Clinical Lab: New Automated Test for the AMCC Panel Payment Algorithm; Organ or Disease Oriented Panel. 1452 Instructions for Downloading the Medicare ZIP Code File for July 2008. 1453 Systems Changes for Prescription Order Numbers for the Competitive Acquisition Program for Part B Drugs and Biologicals; Submitting the Prescription Order Numbers and No Pay Modifiers; Further Editing on the Prescription Order Number; Carrier Specific Requirements for Certain Specialties/Services. 1454 Department of Veterans Affairs Claims Adjudication Services Project—New IOM Chapter—Pub. 100-04, Chapter 37 “Department of Veterans Affairs Claims Adjudication Services Project”; Background on the Veterans Affairs Claims Adjudication Services Project; Requirements for Processing Veterans Affairs Claims; Department of Veterans Affairs Claims Adjudication: Coinsurance and Deductible; Generating Unsolicited Responses to the Veterans Affairs; Use of Legacy Provider Numbers After National Provider Identifiers Are Fully Implemented. 1455 Part B Drug Competitive Acquisition Program Quarterly Drug List Update. 1456 Manualization of Payment for Outpatient End-Stage Renal Disease-Related Services; Monthly Capitation Payment Method for Physicians' Services Furnished to Patients on Maintenance Dialysis; Payment for End-Stage Renal Disease-Related Services Under the Monthly Capitation Payment; (Center-Based Patients); Payment for Managing Patients on Home Dialysis; Patients Who Switch Modalities (Center to Home and Vice Versa); Payment for End-Stage Renal Disease-Related Services (Per Diem); Guidelines for Physician or Practitioner Billing (Per Diem); Data Required on Claim for Monthly Capitation Payment; Controlling Claims Paid Under the Monthly Capitation Payment Method. 1457 Redeterminations of Overpayments; The Redetermination. 1458 Teaching Physician Requirements for End-Stage Renal Disease Monthly; Capitation Payment; Miscellaneous. 1459 Comprehensive Outpatient Rehabilitation Facility Billing Requirement; Updates for Fiscal Year 2008; Allowable Revenue Codes on Comprehensive Outpatient Rehabilitation Facility; 75x Bill Types; Proper Reporting of Nursing Services by CORFS—FIs; Payment of Drugs, Biologicals, and Supplies in a Comprehensive Outpatient Rehabilitation Facility; Billing for Social Work and Psychological Services in a Comprehensive Outpatient Rehabilitation Facility; Billing for Respiratory Therapy Services in a Comprehensive Outpatient Rehabilitation Facility; FI Payment for Pneumococcal Pneumonia Virus, Influenza Virus, and Hepatitis B; Virus Vaccines and Their Administration. 1460 Subsequent Hospital Visits and Hospital Discharge Day Management Services (Codes 99231—99239). 1461 Clarification to CR 5744—Payment Allowance Update for the Influenza Virus Vaccine CPT 90660 and Further Instruction Regarding the Pneumococcal Vaccine CPT 90669; Healthcare Common Procedure Coding System and Diagnosis Codes. 1462 Healthcare Provider Taxonomy Codes Update April 2008. 1463 ZIP Code Files by Date of Service; Claims Processing Instructions for Payment Jurisdiction for Claims Received on or after April 1, 2004; Transition Overview. 1464 Quarterly Update to Correct Coding Initiative

(CCI)Edits, Version 14.1, Effective April 1, 2008. 1465 Payment for Initial Hospital Care Services (Codes 99221-99233) and Observation or Inpatient Care Services (Including Admission and Discharge Services) (Codes 99234-99236). 1466 Payment for Hospital Observation Services (Codes 99217-99220) and Observation or Inpatient Care Services (Including Admission and Discharge Services—Codes 99234-99236). 1467 Modification to Existing Medicare Summary Notice Procedures Regarding the Customer Service Information Box; Title Section of the Medicare Summary Notice; Appeals Section. 1468 Claim Status Category Code and Claim Status Code Update. 1469 Document Control Number Search Feature. 1470 Update to Audiology Policies; Audiological Diagnostic Tests, Speech-Language Evaluations and Treatments. 1471 Healthcare Common Procedure Coding System Codes Subject to and Excluded from Clinical Laboratory Improvement Amendments Edits. 1472 Update of Institutional Claims References; Billing Form as Request for Payment; Beneficiary Request for Payment on Provider Record—UB-04 and Electronic Billing (Part A and Part B); When an Inpatient Admission May Be Changed to Outpatient Status; Noncovered Charges on Outpatient Bills; Line-Item Modifiers Related to Reporting of Noncovered Charges; When Covered and Noncovered Services Are on the Same Institutional Claim Form Prescribed by CMS In Accordance with CMS Instructions; Handling Incomplete or Invalid Submissions; Payment Floor Standards; Data Element Requirements Matrix; Claim Change Reason Codes; Inpatient Part A Hospital Adjustment Bills; Tolerance Guides for Submitting SNF Inpatient Adjustment Requests; SNF Inpatient Claim Adjustment Instructions; Patient Does Not Return From SNF Leave of Absence, and Last Bill Reported; Patient Status as Still Patient (30); Billing and Claims Processing Requirements Related to HINNs; Billing and Claims Processing Requirements Related to Expedited Determinations; Data Element Requirements Matrix (FI); Source of Admission—Outpatient Hospital; Forms; DRG GROUPER Program; Payment to Hospitals and Units Excluded from IPPS for Direct Graduate Medical Education and Nursing and Allied Health (NandAH) Education for Medicare AdvantageEnrollees; Adjustment Bills; Billing Requirements Under IRF PPS; Shared System and CWF Edits; System Edits; Benefits Exhausted; Completion of the Uniform (Institutional Provider) Bill (Form CMS-1450) Notice of Election for RNHCI; Required Data Elements on Claims for RNHCI Services; IPF PPS System Edits; Where to Report Modifiers on the UB-92 (Form CMS-1450) and ANSI X12N Formats; Bill Review for Partial Hospitalization; Services Provided in Community Mental Health Centers; Line Item Date of Service Reporting for Partial Hospitalization; Line Item Date of Service Reporting on Form CMS-1450; Off-Site CORF Services; Notifying Patient of Service Denial; Billing SNF PPS Services; Input/Output Record Layout; Leave of Absence; Services in Excess of Covered Services; Billing Formats; Billing; Calculation of Case Mix Adjusted Composite Rate; Facility Dialysis Bill Processing Procedures; Required Information for In-Facility Claims Paid Under the Composite Rate; Epoetin Alfa

(EPO)Facility Billing Requirements; Darbepoetin Alfa (Aranesp) Facility Billing Requirements; General Intermediary Bill Processing Procedures for Method I Home Dialysis Services; Required Billing Information for Method I Claims; Billable Revenue Codes Under Method II; Unbillable Revenue Codes Under Method II; General Billing Requirements; Special Billing Situations Involving OASIS Assessments; Healthcare Common Procedure Coding System Coding Requirements; Payment Methodology and Healthcare Common Procedure Coding System Coding; General Billing Guidelines—Intermediaries and Carriers; Intermediary Guidelines; Hospital Billing Under Part B; Billing and Payment Instructions for FIs; Requirements for Billing FI for Immunosuppressive Drugs; Claims Submitted to FIs for Mass Immunizations of Influenza and PPV; HCPCS and Diagnosis Codes for Mammography Services; Diagnoses Codes; HHA Recertification for Home Oxygen Therapy; Billing/Claim Formats; ICD-9-CM Diagnosis and Procedure Codes; Billing Requirements for HBO Therapy for the Treatment of Diabetic Wounds of the Lower Extremities; Billing Requirements for Providers Billing Category B IDEs. 1473 Payment for Inpatient Hospital Visits—General (Codes 99221-99239). 1474 Changes to the Long Term Care Hospital Prospective Payment System (LTCH PPS) Pricer Based on the Medicare, Medicaid, and SCHIP Extension Act of 2007 (Recurring CR: R20812Q). 1475 Remittance Advice Remark Code and Claim Adjustment Reason Code Update. 1476 Correction to Low Utilization Payment Adjustment Add-On Payments Under the Refined Home Health Prospective Payment System; Composition of Home Health Prospective Payment System Codes for Home; Health Prospective Payment System; Request for Anticipated Payment; Home Health Prospective Payment System Claims; Input/Output Record Layout; Decision Logic Used by the Pricer on RAPs; Decision Logic Used by the Pricer on Claims; Special Billing Situations Involving OASIS Assessments; Temporary Suspension of Home Health Services. 1477 New Waived Tests. 1478 Additional Clarification to Chapter 17, Section 40, Regarding Processing of Drug Claims with the JW Modifier; Discarded Drugs and Biologicals. 1479 April 2008 Inpatient Rehabilitation Facility Prospective Payment System; Pricer Changes; Income Patients; Low-Income Patient Adjustment: The Supplemental Security Income; Medicare Beneficiary Data for Inpatient Rehabilitation Facilities Paid Under the Prospective Payment System. 1480 Web site for Additions and Deletions of ZIP Codes Requiring a Plus Four ZIP Code Extension. 1481 Type of Service Corrections; Type of Service. 1482 April Update to the 2008 Medicare Physician Fee Schedule Database. 1483 April 2008 Integrated Outpatient Code Editor Specifications Version 9.1. 1484 April 2008 Quarterly Average Sales Price

(ASP)Medicare Part B Drug Pricing Files and Revisions to Prior Quarterly Pricing Files. Medicare Secondary Payer (CMS-Pub. 100-05) 58 Insertion of the Debt Collection System User Guide into the Medicare Secondary Payer Section of the Manual and Associated Revisions/Updates to the Debt Collection System User Guide; 1-DCS. 59 Treasury Collections on Medicare Secondary Payor Debt; Treasury Collections; Background; Intra-Governmental Payment and Collection System; Debt Collection System; Collection/Refund Spreadsheet; Financial Reporting for Collection/Refund Spreadsheet; Debt Paid in Full; Treasury Approved Extended Repayment Schedule; Excess Collections; Applying an Excess Collection; If the Debtor Has Other Outstanding Debt; If the Debtor Has No Other Outstanding Debt; Additonal Instructions for MSP Excess Collection. Medicare Financial Management (CMS-Pub. 100-06) 134 Recurring Update Notification for the Notice of New Interest Rate for Medicare Overpayments and Underpayments—2nd Notification for FY 2008. 135 Clarification Regarding the Coordination of Benefits Agreement Medigap; Claim-Based Crossover Process; Coordination of Medicare and Complementary Insurance Programs. 136 Revisions to Debt Referral Instructions; Treasury Offset Program; Debt Ineligible for Referral; Intent to Refer Letter; Response to Intent to Refer Letter; Debt Collection System; Cross Servicing Collection Efforts; Actions Subsequent to DCS Input; Transmission of Debt; Update to DCS After Transmission; Collections; Background; Intra-governmental Payment and Collection System; Collections Posted to the Debt Collection System; Collection/Refund Spreadsheet; Debt Paid in Full; Extended Repayment Schedule; Excess Collections; Applying Excess Collections; If the Debtor Has Other Outstanding Debt; If the Debtor Has No Other Outstanding Debt; Financial Reporting for Non-MSP Debt; Financial Reporting for Collections Received on Debts From Cross Servicing; Intermediary Claims Accounts Receivable. 137 Reporting Costs Directly Associated with the Reimbursement Advisory Committee Program; Reporting Administrative Costs Directly Associated with the Reimbursement; Advisory Committee Program. Medicare State Operations Manual (CMS-Pub. 100-07) 31 Revision of Appendix P—Survey Protocol for Long Term Care Facilities. 32 Revisions to Chapter 2, “Critical Access Hospitals and Appendix W, Survey Protocol, Regulations and Interpretive Guidelines for Critical Access Hospitals and Swing-Beds in Critical Access Hospitals”; Verification Criteria; Relocation of Critical Access Hospitals With A Grandfathered Necessary Provider Designation. 33 Update to Chapter 2, “The Certification Process,” Sections 2021 and 2022. Medicare Program Integrity (CMS-Pub. 100-08) 231 NPI Number for Medical Review; Data Analysis. 232 Clarification of Standards for Processing CMS-855 Enrollment Applications; CMS-855 Medicare Enrollment Applications; Timeliness and Accuracy Standards; Standards for Initial Applications; Paper Applications—Timeliness; Paper Applications—Accuracy; Web-Based Applications—Timeliness; Web-Based Applications—Accuracy; Standards for Changes of Information; Paper Applications—Timeliness; Paper Applications—Accuracy; Web-Based Applications—Timeliness; Web-Based Applications—Accuracy. 233 Update to Chapter 10; Special Verification Procedures for CMS-855A Applications; Jurisdictional Issues; Changes of Ownership; Definitions; Determining Whether a Change of Ownership

(CHOW)Has Occurred; Processing CHOW Applications; Intervening CHOWs; EFT Payments and CHOWs; Tie-In Notices; Out-of-State Practice Locations for Certified Providers; State Surveys and the CMS-855A; Sole Proprietorships; Additional CMS-855A Processing Instructions; Special Verification Procedures for Enrolling Independent CLIA Labs, Ambulatory Surgical Centers and Portable X-Ray Suppliers; CLIA Labs; ASCs and Portable X-Ray Suppliers; ASC/PXRS Changes of Ownership; Determining Whether a CHOW Has Occurred; EFT Payments and CHOWs; ASC/PXRS Tie-In Notices; Out-of-State Practice Locations for Certified Suppliers; State Surveys and the CMS-855B; Non-Certified Suppliers and Individual Practitioners; Certified Providers and Certified Suppliers; Approval of DMEPOS Suppliers; Non-CMS-855 Enrollment Activities; Contractor Communications; Reserved for Future Use; External Reporting Requirements; Reserved for Future Use. 234 Revision to Instructions Relating to Compliance Standards for Independent Diagnostic Testing Facilities; IDTF Standards; Supervising Physicians. 235 Additional Information on Reporting a National Provider Identifier for Ordering/Referring and Attending/Operating/Other Service Facility for Medicare; Claims. 236 Update to Chapter 10; Returning the Application; National Provider Identifier; Changes of Information; General Procedures; Changes of Information and Complete CMS-855 Applications; Incomplete or Unverifiable Changes of Information; Special Instructions for Certified Providers, ASC, and Portable X-Ray Supplies (PXRSs); Voluntary Terminations; Electronic Fund Transfers; Carrier-Enrolled Organizational Suppliers; CLIA Labs; Mammography Screening Centers; Pharmacies; Portable X-Ray Suppliers; Radiation Therapy Centers; Slide Preparation Facilities; Physicians; Physician Assistants; Psychologists Practicing Independently; Registered Dietitians; CMS or Contractor Issued Deactivations; Revocations Involving Certified Suppliers and Providers; Special Durable Medical Equipment, Prosthetics, Orthotics, and Supplies; Instructions; DMEPOS Supplier Accreditation; Enrolling Indian Health Service Facilities as DMEPOS Suppliers. 237 PIMR Annual Update; Coding T and F Codes. 238 Correction of the Medicare Contractor System Downcoding Problem in Program Integrity Management Reporting System. 239 Additional Instructions for the Execution of the Medicare Provider Enrollment; Demonstration for Home Health Agencies in High-Risk Areas. 240 Revise the Fiscal Intermediary Shared System

(FISS)to Include All 11x Claims in the Nightly Universe Files Generated for the Comprehensive Error Rate Testing Program; Providing Sample Information to the Contractor. 241 Flagging Health Insurance Claim Numbers in the Medicare Carrier System for Pre-Payment Review/Audit; Medical Review for Benefit Integrity Purposes. 242 Items and Special Services Having Special DME Review Considerations; Rules Concerning Orders Home Use of DME; Physician Orders; Verbal and Preliminary Written Orders; Detailed Written Orders; Written Orders Prior to Delivery; Requirements of New Orders; Certificates of Medical Necessity and DME Information Forms; Completing a CMN or DIF; Cover Letters for CMNs; Reserved for Future Use; DME MACs and DME PSCs Authority to Initiate an Overpayment and/or Civil Monetary Penalty When Valid CMNs Are Identified; Nurse Practitioner or Clinical Nurse Specialist Rules Concerning Orders and CMNs; Physician Assistant Rules Concerning Orders and CMNs; Documentation in the Patient's Medical Record; Supplier Documentation; Evidence of Medical Necessity; Evidence of Medical Necessity for the Oxygen CMN; Evidence of Medical Necessity: Wheelchair and Power-Operated Vehicle Claims; Period of Medical Necessity—Home Dialysis Equipment; Safeguards in Making Monthly Payments; Reserved for Future Use; Pick-up Slips; Incurred Expenses for DME and Orthotic and Prosthetic Devices; Reserved for Future Use; Items Eligible for ADMCs; Instructions for Submitting Advance Determination of Medicare Coverage Requests; Instructions Processing Advance Determination of Medicare Coverage Requests; Affirmative Advance Determination of Medicare Coverage Decision Instructions; Processing Advance Determination of Medicare Coverage Requests; DME MAC Tracking. 243 Implementation of a Program Integrity Management Reporting Edit Effectiveness; Report for Program Safeguard Contractors. 244 Collapsing Medicare Provider Transaction Access Numbers to Ensure a One-to-One; National Provider Identifier Match. 245 Processing Part B Therapy Claims While the Therapy Cap Exceptions Process is in Effect; Exception From the Uniform Dollar Limitation (“Therapy Cap”). 246 Clarification of Items in Chapter 10; Practice Location Information; Certification Statement; Desk and Site Reviews; Non-Participating Emergency Hospitals and Veterans Administration Hospitals. 247 Model Letters for Provider Enrollment. 248 Signature Requirements Clarification; Documentation Specifications for Areas Selected for Prepayment or Postpayment; Medical Review. 249 Carrier Assignment of Provider Identification Numbers. Medicare Contractor Beneficiary and Provider Communications (CMS-Pub. 100-09) 21 Instructions Related to the CMS Standardized Provider Inquiry Chart for FY 2008; Data to be Reported Monthly; Provider Inquiry Reporting Standardization; Inquiry Tracking; Updates to Chart; General Requirements; Data to Be Reported Monthly; Provider Inquiry Standardized Categories. Medicare End Stage Renal Disease Network Organizations (CMS-Pub 100-14) 00 None. Medicare Managed Care (CMS-Pub. 100-16) 00 None. Medicare Business Partners Systems Security (CMS-Pub. 100-17) 00 None. Demonstrations (CMS-Pub. 100-19) 55 Medicare Acute Care Episode Demonstration. 56 Implementation of Laboratory Competitive Bidding Demonstration. 57 Laboratory Competitive Bidding Demonstration (Second Phase of Implementation). One Time Notification (CMS-Pub. 100-20) 308 This Transmittal is being Rescinded and Replaced by Transmittal 328. 309 New Coordination of Benefits Agreement

(COBA)Editing to Address Duplicate Crossover Claim File Submissions. 310 Requirements for Including an 8-Digit Clinical Trial Number on Claims. 311 Support Income Tax Reporting. 312 EMERGENCY—Legislative Change Affecting the 2008 Medicare Physician Fee Schedule and Extension of the 2008 Participation Open Enrollment Period. 313 New Contractor Numbers for the States of Colorado, New Mexico, Oklahoma, and Texas in Jurisdiction 4 Part AB Medicare Administrative Services Workload. 314 Limitation of Recoupment—FISS Recoupment and Claims Adjustment Process. 315 BOI Extract for CWF and MBD. 316 Submitting Outpatient Provider Specific Data. 317 Production Region Split and New Contractor Number for Riverbend, New Jersey; Part A Workload. 318 Create User Account for Next Generation Desktop on Common Working File. 319 Fiscal Intermediary Shared Mid-Month Production Region Split. 320 Jurisdiction 3 Part A Merge. 321 Refinements in Cost Reporting Due to CMS' Revised Procedures for Recalibrating Relative Weights Under the Inpatient Prospective Payment System. 322 Limitation of Recoupment—FISS Recoupment and Claims Adjustment Process. 323 New Contractor Numbers for the State of California Jurisdiction 1 Part B Medicare Administrative Contractor Workload. 324 New Contractor Numbers for the States of Hawaii and Nevada and American Samoa, Guam, and Northern Mariana Islands Jurisdiction 1 Part B Medicare Administrative Contractor Workload. 325 New Contractor Numbers for the States of California, Hawaii, and Nevada and American Samoa, Guam, and Northern Mariana Islands Jurisdiction 1 Part A Medicare Administrative Contractor Workload. 326 Medicare Fraud Edit Module. 327 Issued to a specific audience, not posted to Internet/Intranet due to Sensitivity of Instruction. 328 Split of HI/NV/AZ Part B Workloads and Merge of AZ/UT/MT. Addendum IV.—Regulation Documents Published in the Federal Register January Through March 2008 Publication date FR Vol. 73 Page No. 42 CFR parts affected File code Title of regulation January 3, 2008 404 414 CMS-1385-F2 Medicare Program; Revisions to Payment Policies Under the Physician Fee Schedule, and Other Part B Payment Policies CY 2008; Delay of Effective Date of the Anti-Markup Provisions at 42 CFR 414.50 for Certain Arrangements. January 8, 2008 1301 422 and 423 CMS-4113-P Medicare Program; Option for Prescription Drug Plans to Lower Their Premiums for Low-Income Subsidy Beneficiaries. January 15, 2008 2431 410, 414, 424, and 484 CMS-1385-F3 Medicare Program; Revisions to Payment Policies Under the Physician Fee Schedule, and Other Part B Payment Policies for CY 2008; Revisions to the Payment Policies of Ambulance Services Under the Ambulance Fee Schedule for CY 2008; and the Amendment of the E-Prescribing Exemption for Computer-Generated Facsimile Transmissions; Correcting Amendment. January 15, 2008 2433 414 CMS-1385-CN3 Medicare Program; Revisions to Payment Policies Under the Physician Fee Schedule, and Other Part B Payment Policies for CY 2008; Delay of the Date of Applicability of the Revised Anti-Markup Provisions for Certain Services Furnished in Certain Locations (§ 414.50); Correction. January 15, 2008 2568 409, 410, 411, 413, 414, 415, 418, 423, 424, 482, 484, and 485 CMS-1385-CN2 Medicare Program; Revisions to Payment Policies Under the Physician Fee Schedule, and Other Part B Payment Policies for CY 2008; Revisions to the Payment Policies for Ambulance Services Under the Ambulance Fee Schedule for CY 2008; and the Amendment of the E-Prescribing Exemption for Computer-Generated Facsimile Transmissions; Corrections. January 18, 2008 3405 488 CMS-2278-IFC3 Revisit User Fee Program for Medicare Survey and Certification Activities. January 18, 2008 3546 441 CMS-2229-P Medicaid Program; Self-Directed Personal Assistance Services Program State Plan Option (Cash and Counseling). January 25, 2008 4503 424 CMS-6036-P Medicare Program; Establishing Additional Medicare Durable Medical Equipment, Prosthetics, Orthotics, and Supplies (DMEPOS) Supplier Enrollment Safteguards. January 28, 2008 4870 CMS-3195-N Medicare Program; Request for Nominations for Members of the Medicare Evidence Development and Coverage Advisory Committee (MedCAC). January 28, 2008 4871 CMS-1499-N Medicare Program; Meeting of the Practicing Physicians Advisory Council (PPAC)—March 3, 2008. January 29, 2008 5342 412 CMS-1393-P Medicare Program; Prospective Payment System for Long-Term Care Hospitals RY 2009: Proposed Annual Payment Rate Updates, Policy Changes, and Clarifications. February 4, 2008 6451 400, 405, 410, 412, 413, 414, 488, and 494 CMS-3818-RCN Medicare and Medicaid Programs; Conditions for Coverage for End-Stage Renal Disease Facilities—Extension of Timeline for Publication of Final Rule. February 6, 2008 6971 CMS-5014-N Medicare Program; Rural Community Hospital Demonstration Program; Solicitation of Additional Participants. February 22, 2008 9812 CMS-7008-N Medicare Program; Announcement of Meeting of the Advisory Panel on Medicare Education; March 11, 2008. February 22, 2008 9679 411 and 489 CMS-6272-F Medicare Program; Medicare Secondary Payer

(MSP)Amendments. February 22, 2008 9672 410 CMS-6024-F Medicare Program; Prior Determination for Certain Items and Services. February 22, 2008 9811 CMS-3186-FN Medicare Program; Approval of Application by the Indian Health Service

(IHS)for Continued Recognition as a National Accreditation Organization that Accredits American Indian and Alaska Native (AI/AN) Entities to Furnish Outpatient Diabetes Self-Management Training. February 22, 2008 9685 433 CMS-2275-F Medicaid Program; Health Care-Related Taxes. February 22, 2008 9727 447 and 457 CMS-2244-P Medicaid Program; Premiums and Cost Sharing. February 22, 2008 9714 440 CMS-2232-P Medicaid Program; State Flexibility for Medicaid Benefit Packages. February 22, 2008 9814 CMS-1549-N Medicare Program; Public Meetings in Calendar Year 2008 for All New Public Requests for Revisions to the Healthcare Common Procedure Coding System (HCPCS) Coding and Payment Determinations. February 22, 2008 9807 CMS-1491-N Medicare Program; Extension of Certain Hospital Wage Index Reclassifications. February 22, 2008 9810 CMS-1395-N Medicare Program; Request for Nominations to the Advisory Panel on Ambulatory Payment Classification Groups. February 22, 2008 9860 410, 411, 412, 413, 414, 416, 419, 482, and 485 CMS-1392-CN CMS-1533-CN CMS-1531-CN Medicare Program; Changes to the Hospital Outpatient Prospective Payment System and CY 2008 Payment Rates, the Ambulatory Surgical Center Payment System and CY 2008 Payment Rates, the Hospital Inpatient Prospective Payment System and FY 2008 Payment Rates; and Payments for Graduate Medical Education for Affiliated Teaching Hospitals in Certain Emergency Situations Medicare and Medicaid Programs: Hospital Conditions of Participation; Necessary Provider Designations of Critical Access Hospitals; Correction. February 29, 2008 11043 401 and 405 CMS-4064-RCN Medicare Program; Changes to the Medicare Claims Appeal Procedures; Continuation of Effectiveness and Extension of Timeline for Publication of Final Rule. February 29, 2008 11120 CMS-3196-N Medicare Program; Town Hall Meeting of the Medicare Evidence Development of Coverage Advisory Committee—April 30, 2008. February 29, 2008 11043 488 CMS-2278-IFC4 Revisit User Fee Program for Medicare Survey and Certification Activities. March 14, 2008 13785 447 CMS-2238-IFC Medicaid Program; Multiple Source Drug Definition. March 17, 2008 14342 423 CMS-4127-P Medicare Program; Application of Certain Appeals Provisions to the Medicare Prescription Drug Appeals Process. March 28, 2008 16690 CMS-2277-CN Medicare and Medicaid Programs; Approval of the Joint Commission for Continued Deeming Authority for Home Health Agencies. March 28, 2008 16688 CMS-2276-FN Medicare and Medicaid Programs; Approval of the Community Health Accreditation Program for Continued Deeming Authority for Home Health Agencies. Addendum V—National Coverage Determinations [January Through March 2008] A national coverage determination

(NCD)is a determination by the Secretary with respect to whether or not a particular item or service is covered nationally under Title XVIII of the Social Security Act, but does not include a determination of what code, if any, is assigned to a particular item or service covered under this title, or determination with respect to the amount of payment made for a particular item or service so covered. We include below all of the NCDs that were issued during the quarter covered by this notice. The entries below include information concerning completed decisions as well as sections on program and decision memoranda, which also announce pending decisions or, in some cases, explain why it was not appropriate to issue an NCD. We identify completed decisions by the section of the NCDM in which the decision appears, the title, the date the publication was issued, and the effective date of the decision. Information on completed decisions as well as pending decisions has also been posted on the CMS Web site at *http://cms.hhs.gov/coverage.* Title NCDM section TN No. Issue date Effective date Erythropoiesis Stimulating Agents

(ESAs)in Cancer and Related Neoplastic Conditions 110.21 R80NCD 01/14/2008 07/30/2007 Addendum VI—FDA-Approved Category B IDEs [January Through March 2008] Under the Food, Drug, and Cosmetic Act (21 U.S.C. 360c) devices fall into one of three classes. To assist CMS under this categorization process, the FDA assigns one of two categories to each FDA-approved IDE. Category A refers to experimental IDEs, and Category B refers to non-experimental IDEs. To obtain more information about the classes or categories, please refer to the **Federal Register** notice published on April 21, 1997 (62 FR 19328). The following list includes all Category B IDEs approved by FDA during the first quarter, January through March 2008. IDE Category G070016 B G070087 B G070116 B G070118 B G070137 B G070138 B G070155 B G070168 B G070191 B G070197 B G070202 B G070206 B G070219 B G070238 B G070240 B G080001 B G080005 B G080009 B G080014 B G080015 B G080018 B G080019 B G080021 B G080022 B G080025 B G080031 B G080032 B G080033 B G080034 B Addendum VII—Approval Numbers for Collections of Information Below we list all approval numbers for collections of information in the referenced sections of CMS regulations in Title 42; Title 45, Subchapter C; and Title 20 of the Code of Federal Regulations, which have been approved by the Office of Management and Budget: OMB Control Numbers Approved CFR Sections in Title 42, Title 45, and Title 20 ( **Note:** Sections in Title 45 are preceded by “45 CFR,” and sections in Title 20 are preceded by “20 CFR”). OMB No. Approved CFR sections 0938-0008 Part 424, Subpart C 0938-0022 413.20, 413.24, 413.106 0938-0023 424.103 0938-0025 406.28, 407.27 0938-0027 486.100-486.110 0938-0033 405.807 0938-0035 407.40 0938-0037 413.20, 413.24 0938-0041 408.6, 408.202 0938-0042 410.1, 410.40, 424.124, 424.601, 414.605, 414.610, 414.615, 414.620, 414.625, 424.32 0938-0045 405.711 0938-0046 405.2133 0938-0050 413.20, 413.24 0938-0062 431.151, 435.151, 435.1009, 440.220, 440.250, 442.1, 442.10-442.16, 442.30, 442.40, 442.42, 442.100-442.119, 483.400-483.480, 488.332, 488.400, 498.3-498.5 0938-0065 485.701-485.729 0938-0074 491.1-491.11 0938-0080 406.7, 406.13 0938-0086 420.200-420.206, 455.100-455.106 0938-0101 430.30 0938-0102 413.20, 413.24 0938-0107 413.20, 413.24 0938-0146 431.800-431.865 0938-0147 431.800-431.865 0938-0151 493.1-493.2001 0938-0155 405.2470 0938-0193 430.10-430.20, 440.167 0938-0202 413.17, 413.20 0938-0214 411.25, 489.2, 489.20 0938-0236 413.20, 413.24 0938-0242 488.26 and 442.30 0938-0245 407.10, 407.11 0938-0246 431.800-431.865 0938-0251 406.7 0938-0266 416.1-416.150 0938-0267 485.56, 485.58, 485.60, 485.64, 485.66 0938-0269 412.116, 412.632, 413.64, 413.350, 484.245 0938-0270 405.376 0938-0272 440.180, 441.300-441.310 0938-0273 485.701-485.729 0938-0279 424.5 0938-0287 447.31 0938-0296 413.170, 413.184 0938-0301 413.20, 413.24, 415.60 0938-0302 418.22, 418.24, 418.28, 418.56, 418.58, 418.70, 418.74, 418.83, 418.96, 418.100 0938-0313 489.11, 489.20 0938-0328 482.12, 482.13, 482.21, 482.22, 482.27, 482.30, 482.41, 482.43, 482.45, 482.53, 482.56, 482.57, 482.60, 482.61, 482.62, 482.66, 485.618, 485.631 0938-0334 491.9, 491.10 0938-0338 486.104, 486.106, 486.110 0938-0354 441.50 0938-0355 442.30, 488.26 0938-0358 488.26 0938-0359 412.40-412.52 0938-0360 488.60 0938-0365 484.10, 484.12, 484.14, 484.16, 484.18, , 484.36, 484.48, 484.52 0938-0372 414.330 0938-0378 482.60-482.62 0938-0379 442.30, 488.26 0938-0386 405.2100-405.2171 0938-0391 488.18, 488.26, 488.28 0938-0426 480.104, 480.105, 480.116, 480.134 0938-0429 447.53 0938-0443 478.18, 478.34, 478.36, 478.42 0938-0444 1004.40, 1004.50, 1004.60, 1004.70 0938-0445 412.44, 412.46, 431.630, 476.71, 476.74, 476.78 0938-0447 405.2133 0938-0448 405.2133, 45 CFR 5, 5b; 20 CFR parts 401, 422E 0938-0449440.180, 441.300-441.310 0938-0454 424.20 0938-0456 412.105 0938-0463 413.20, 413.24, 413.106 0938-0467 431.17, 431.306, 435.910, 435.920, 435.940-435.960 0938-0469 417.126, 422.502, 422.516 0938-0470 417.143, 422.6 0938-0477 412.92 0938-0484 424.123 0938-0501 406.15 0938-0502 433.138 0938-0512 486.301-486.348 0938-0526 475.102, 475.103, 475.104, 475.105, 475.106 0938-0534 410.38, 424.5 0938-0544 493.1-493.2001 0938-0564 411.32 0938-0565 411.20-411.206 0938-0566 411.404, 411.406, 411.408 0938-0573 412.256 0938-0578 447.534 0938-0581 493.1-493.2001 0938-0599 493.1-493.2001 0938-0600 405.371, 405.378, 413.20 0938-0610 417.436, 417.801, 422.128, 430.12, 431.20, 431.107, 483.10, 484.10, 489.102 0938-0612 493.801, 493.803, 493.1232, 493.1233, 493.1234, 493.1235, 493.1236, 493.1239, 493.1241, 493.1242, 493.1249, 493.1251, 493,1252, 493.1253, 493.1254, 493.1255, 493.1256, 493.1261, 493.1262, 493.1263, 493.1269, 493.1273, 493.1274, 493.1278, 493.1283, 493.1289, 493.1291, 493.1299 0938-0618 433.68, 433.74, 447.272 0938-0653 493.1771, 493.1773, 493.1777 0938-0657 405.2110, 405.2112 0938-0658 405.2110, 405.2112 0938-0667 482.12, 488.18, 489.20, 489.24 0938-0686 493.551-493.557 0938-0688 486.301-486.325 0938-0691 412.106 0938-0692 466.78, 489.20, 489.27 0938-0701 422.152 0938-0702 45 CFR 146.111, 146.115, 146.117, 146.150, 146.152, 146.160, 146.180 0938-0703 45 CFR 148.120, 148.122, 148.124, 148.126, 148.128 0938-0714 411.370-411.389 0938-0717 424.57 0938-0721 410.33 0938-0723 421.300-421.316 0938-0730 405.410, 405.430, 405.435, 405.440, 405.445, 405.455, 410.61, 415.110, 424.24 0938-0732 417.126, 417.470 0938-0734 45 CFR 5b 0938-0739 413.337, 413.343, 424.32, 483.20 0938-0749 424.57 0938-0753 422.000-422.700 0938-0754 441.151, 441.152 0938-0758 413.20, 413.24 0938-0760 484.55, 484.205, 484.245, 484.250 0938-0761 484.11, 484.20 0938-0763 422.250, 422.252, 422.254, 422.256, 422.258, 422.262, 422.264, 422.266, 422.270, 422.300, 422.304, 422.306, 422.308, 422.310, 422.312, 422.314, 422.316, 422.318, 422.320, 422.322, 422.324, 423.251, 423.258, 423.265, 423.272, 423.286, 423.293, 423.301, 423.308, 423.315, 423.322, 423.329, 423.336, 423.343, 423.346, 423.350 0938-0770 410.2 0938-0778 422.111, 422.564 0938-0779 417.126, 417.470, 422.64, 422.210 0938-0781 411.404, 484.10 0938-0786 438.352, 438.360, 438.362, 438.364 0938-0790 460.12-460.210 0938-0792 491.8, 491.11 0938-0796 422.64 0938-0798 413.24, 413.65, 419.42 0938-0802 419.43 0938-0818 410.141-410.146, 414.63 0938-0829 422.568 0938-0832 Parts 489 and 491 0938-0833 483.350-483.376 0938-0841 431.636, 457.50, 457.60, 457.70, 457.340, 457.350, 457.431, 457.440, 457.525, 457.560, 457.570, 457.740, 457.750, 457.810, 457.940, 457.945, 457.965, 457.985, 457.1005, 457.1015, 457.1180 0938-0842 412.23, 412.604, 412.606, 412.608, 412.610, 412.614, 412.618, 412.626, 413.64 0938-0846 411.352-411.361 0938-0857 Part 419 0938-0860 Part 419 0938-0866 45 CFR part 162 0938-0872 413.337, 483.20 0938-0873 422.152 0938-0874 45 CFR parts 160 and 162 0938-0878 Part 422 Subparts F and G 0938-0887 45 CFR 148.316, 148.318, 148.320 0938-0897 412.22, 412.533 0938-0907 412.230, 412.304, 413.65 0938-0910 422.620, 422.624, 422.626 0938-0911 426.400, 426.500 0938-0915 421.120, 421.122 0938-0916 483.160 0938-0920 438.6, 438.8, 438.10, 438.12, 438.50, 438.56, 438.102, 438.114, 438.202, 438.206, 438.207, 438.240, 438.242, 438.402, 438.404, 438.406, 438.408, 438.410, 438.414, 438.416, 438.604, 438.710, 438.722, 438.724, 438.810 0938-0921 414.804 0938-0931 45 CFR 142.408, 162.408, and 162.406 0938-0933 438.50 0938-0935 422 Subparts F and K 0938-0936 423 0938-0939 405.502 0938-0944 422.250, 422.252, 422.254, 422.256, 422.258, 422.262, 422.264, 422.266, 422.270, 422.300, 422.304, 422.306, 422.308, 422.310, 422.312, 422.314, 422.316, 422.318, 422.320, 422.322, 422.324, 423.251, 423.258, 423.265, 423.272, 423.279, 423.286, 423.293, 423.301, 423.308, 423.315, 423.322, 423.329, 423.336, 423.343, 423.346, 423.350 0938-0950 405.910 0938-0951 423.48 0938-0953 405.1200 and 405.1202 0938-0954 414.906, 414.908, 414.910, 414.914, 414.916 0938-0957 Part 423 Subpart R 0938-0964 403.460, 411.47 0938-0969 421.405 0938-0975 423.562(a) 0938-0976 423.568 0938-0977 Part 423 Subpart R 0938-0978 423.464 0938-0982 422.310, 423.301, 423.322, 423.875, 423.888 0938-0986 412.20-412.30 0938-0990 423.56 0938-0992 423.505, 423.514 0938-0993 1396 0938-0997 424.5 0938-0999 42 CFR 424 Subpart C 0938-1009 411.357(v), 411.357(w) 0938-1020 412.525(a)(4), 412.529(c)(3), 412.84(i)(2) 0938-1024 1396 0938-1026 447.52 0938-1013 423.56e 0938-1019 405.1206, 422.622 0938-1023 422.152a 0938-1034 42 CFR 489.20 Addendum VIII—Medicare-Approved Carotid Stent Facilities [January Through March 2008] On March 17, 2005, we issued our decision memorandum on carotid artery stenting. We determined that carotid artery stenting with embolic protection is reasonable and necessary only if performed in facilities that have been determined to be competent in performing the evaluation, procedure, and follow-up necessary to ensure optimal patient outcomes. We have created a list of minimum standards for facilities modeled in part on professional society statements on competency. All facilities must at least meet our standards in order to receive coverage for carotid artery stenting for high risk patients. Facility Provider No. Effective date State Additional information Union Hospital of Cecil County, 106 Bow Street, Elkton, MD 21921 210032 01/04/2008 MD. Southwest Healthcare System, 36485 Inland Valley Drive, Wildomar, CA 92595 050701 01/14/2008 CA. Long Island College Hospital, 339 Hicks Street, Brooklyn, NY 11201 330152 02/15/2008 NY. Halifax Regional Health System, 2204 Wilborn Avenue, South Boston, VA 24592 490013 02/27/2008 VA. Montgomery Hospital, 1301 Powell Street, Norristown, PA 19404-0992 390108 02/27/2008 PA. PO Box 992. Addendum IX—American College of Cardiology's National Cardiovascular Data Registry Sites [January Through December 2007] In order to obtain reimbursement, Medicare national coverage policy requires that providers implanting ICDs for primary prevention clinical indications (that is, patients without a history of cardiac arrest or spontaneous arrhythmia) report data on each primary prevention ICD procedure. This policy became effective January 27, 2005. Details of the clinical indications that are covered by Medicare and their respective data reporting requirements are available in the Medicare National Coverage Determination

(NCD)Manual, which is on the Centers for Medicare & Medicaid Services

(CMS)Web site at *http://www.cms.hhs.gov/Manuals/IOM/itemdetail.asp?filterType=none&filterByDID=99&sortByDID=1&sortOrder=ascending&itemID=CMS014961.* A provider can use either of two mechanisms to satisfy the data reporting requirement. Patients may be enrolled either in an Investigational Device Exemption trial studying ICDs as identified by the FDA or in the American College of Cardiology's National Cardiovascular Data Registry (ACC-NCDR) ICD registry. Therefore, in order for a beneficiary to receive a Medicare-covered ICD implantation for primary prevention, the beneficiary must receive the scan in a facility that participates in the ACC-NCDR ICD registry. We maintain a list of facilities that have been enrolled in this registry. Addendum IX includes the facilities that have been designated in the quarter covered by this notice. Facility name Address 1 Address 2 City State Zip Phone Fax Abbott Northwestern Hospital 800 East 28th Street (Internal Zip 33210) Minneapolis MN 55407 612-863-6221 612-863-3771 Adena Regional Medical Center 272 Hospital Road Chillicothe OH 45601 740-779-7552 Adventist Medical Center 10123 SE Market Street Portland OR 97216 503-251-6172 503-251-6236 Advocate Christ Medical Center 4440 West 95th Street #127NOB Oak Lawn IL 60453 708-684-3160 708-684-3260 Advocate Good Shepherd Hospital 450 W. Highway 22 Barrington IL 60010 847-842-3755 847-842-2992 Advocate Illinos Masonic Medical Center 836 W. Wellington Chicago IL 60657 773-296-5651 Advocate South Suburban Hospital 17800 S. Kedzie Avenue Hazel Crest IL 60429 708-213-3332 708-213-0161 Aiken Regional Medical Center 302 University Parkway Aiken SC 29802 803-641-5280 803-641-5054 Akron City Hospital 525 East Market Street Akron OH 44309-2090 330-375-4940 330-375-7655 Akron General Medical Center 400 Wabash Avenue Heart & Vascular Center Akron OH 44307 330-344-1119 330-434-4739 Alaska Regional Hospital 2801 Debarr Road Anchorage AK 99508 907-264-1899 907-264-1143 Albany Medical Center Hospital 43 New Scotland Avenue Albany NY 12208 518-262-2581 518-262-2626 Albert Einstein Medical Center 5501 Old York Road Philadelphia PA 19141 215-456-7013 215-456-3533 Alexian Brothers Medical Center 800 Biesterfield Road Elk Grove Village IL 60007-3311 847-437-5500 x4160 847-981-2037 Alpena Regional Medical Center 1501 W. Chisholm Street Alpena MI 49707

(989)356-7360

(989)356-7551 Alta Bates Medical Center 2450 Ashby Avenue Berkeley CA 94705 510-204-1758 Alta Bates Summit Medical Center 350 Hawthorne Avenue Oakland CA 94609 (510)655-4000 3894 Alton Memorial Hospital 1 Memorial Drive Alton IL 62067 618-463-7621 618-463-7766 Alvarado Hospital 6645 Alvarado Road San Diego CA 92120 619-229-4733 619-229-7272 Anaheim Memorial Medical Ctr 1111 W. La Palma Avenue Anaheim CA 92801 714-999-3931

(714)999-6063 AnMed Health 800 Fant Street Anderson SC 29621 864-512-1342 864-260-3975 Appleton Medical Center/ThedaClark Medical Center 1818 N. Meade Street Rm 165-B Appleton WI 54911 920-735-7573 920-738-6353 Arizona Heart Hospital Arizona Heart Hospital 1930 East Thomas Road Phoenix AZ 85016 602-532-1035 602-532-2000 Aspirus Wausau Hospital 333 Pine Ridge Boulevard Wausau WI 54401 715-847-2504 715-847-2207 Athens Regional Medical Center 1199 Prince Avenue Athens GA 30606 706 475 5761 706 475 5779 Atlanticare Regional Medical Center 2500 English Creek Avenue Egg Habour Township NJ 08234 609 748 7502 Audrain Medical Center 620 E. Monroe Street Mexico MO 65265 573-582-8004 573-582-3739 Aventura Hospital and Medical Center 20900 Biscayne Boulevard Aventura FL 33180 305-937-6903 305-682-7033 Avera Heart Hospital of South Dakota 4500 West 69th Street Sioux Falls SD 57108 605-977-7025 605-977-7001 Avera Sacred Heart Hospital 501 Summit Yankton SD 57078 605-668-8140 605-668-8058 Bakersfield Heart Hospital 3001 Sillect Avenue Bakersfield CA 93308 661-316-6081 661-316-6089 Ball Memorial Hospital 2401 University Avenue Muncie IN 47303 765-747-4284 765-747-8406 Banner Desert Medical Center Banner Desert Medical Center, Quality Management 1400 S. Dobson Road Mesa AZ 85202 480-512-3321 480-512-5570 Banner Estrella Medical Center 9201 W. Thomas Road Phoenix AZ 85037 623-327-5311 Banner Good Samaritan Med Center 1111 East McDowell Road Phoenix AZ 85006-2612 602-239-4041 602-239-3072 Banner Heart Hospital 6750 E. Baywood Avenue Mesa AZ 85206 480-854-5100 480-854-5009 Banner Thunderbird Med Center 5555 W. Thunderbird Road Glendale AZ 85306 602-865-2126 602-865-4769 Baptist Health Medical Center 3333 Springhill Drive North Little Rock AR 72117 501-202-3774

(501)202-6850 Baptist Hospital 1000 W. Moreno Street Pensacola FL 32501

(850)469-5881

(850)469-5057 Baptist Hospital West 137 Blount Avenue Knoxville TN 37920 865-549-2651 865-549-2967 Baptist Medical Center 111 Dallas Street San Antonio TX 78205 210-297-1264 210-297-0926 Baptist Memorial Hospital Golden Triangle 2520 5th Street NorthPO Box 1307 Columbus MS 39703 662-244-1032 662-244-1016 Baptist Memorial Hospital North Mississippi 2301 South Lamar Boulevard Oxford MS 38655 662-232-8166 662-232-8161 Baptist Memorial Hospital—Desoto 7601 Southcrest Parkway Southaven MS 38671 662-349-5253 662-349-4091 Baptist Memorial Hospital—Union City 1201 Bishop Street Union City TN 38261 731-884-8777 Baptist St. Anthony's Health Systems 1600 Wallace Boulevard Amarillo TX 79106 806-212-5935 Barberton Citizens Hospital 155 5th Street NE Barberton OH 44203 330-615-3919 330-615-3921 Barnes Jewish Hospital/Washington University #1 Barnes Jewish Hospital Plaza SW Tower—Main. Mailstop 90-59-315 Saint Louis MO 63110-9930 314-362-9404 314-362-0079 Barstow Community Hospital 555 South Seventh Street Barstow CA 92311 760-957-3346 Bassett Healthcare—(Mary Imogene Bassett Hospital) One Atwell Road Cooperstown NY 13326 607-547-4808 607-547-6892 Baton Rouge General Medical Center 3600 Florida Boulevard Baton Rouge LA 70806 225-381-6672 225-381-6225 Battle Creek Health System 300 North Avenue Battle Creek MI 49016 616-966-8165 616-966-8061 Baxter Regional Medical Center Attn: A/P 624 Hospital Drive Mountain Home AR 72653 870-508-1460 Bay Medical Center 615 North Bonita Avenue Panama City FL 32401 850-747-6135 850-747-6672 Bay Regional Medical Center 1900 Columbus Avenue Bay City MI 48708 989-894-8616 989-893-3434 Bayfront Medical Center 701 Sixth Street South St. Petersburg FL 33701 727.893.6273 727.893.6930 Bayhealth Medical Center

(KGH)640 S. State Street Dover DE 19901

(302)744-6636

(302)744-6690 Baylor All Saints Medical Center at Fort Worth 1400 8th Avenue Fort Worth TX 76104 817-922-1876 817-922-1236 Baylor Jack and Jane Hamilton Heart and Vascular Hospital 621 North Hall Street Dallas TX 75226 214-820-0663 Baylor Medical Center at Irving 1901 North MacArthur Boulevard Irving TX 75061 972-579-8525 972-579-8557 Baylor Regional Medical Center at Grapevine 1650 West College Street Grapevine TX 76051 817-424-4793 817-329-2845 Bayshore Medical Center 4000 Spencer Highway Pasadena TX 77504 713-359-1379 713-359-2223 Baystate Medical Center 759 Chestnut Street Springfield 4 4558 Springfield MA 01199

(413)794-5257 413-794-9294 Bellevue Hospital Center 462 First Avenue New York NY 10016 212-562-2227 212-562-2991 Bellin Memorial Hospital 744 S. Webster Avenue Cardiac Data Center 5th Floor Green Bay WI 54301 920-433-3785 920-433-7450 Benefis Healthcare 1101 26th Street South Great Falls MT 59405-5161 406-455-5693 406-455-4972 Bert Fish Medical Center 401 Palmetto Street New Smyrna Beach FL 32168 386-424-5288 Bethesda Memorial Hospital 2815 S. Seacrest Blvd Boynton Beach FL 33435 561-737-7733 x5422 Biloxi Regional Medical Center 150 Reynoir Street Biloxi MS 39531 228-436-1469 228-436-1580 Blake Medical Center 2020 59th Street West Bradenton FL 34209 941-798-6447 941-798-6439 Blanchard Valley Hospital 1900 South Main Street HeartCare Center Findlay OH 45840 419.429.6485 419.427.7626 Blessing Hospital 1005 Broadway PO Box 7005 Quincy IL 62305-7005 217-223-8400 ext 6669 217-228-3097 Bloomington Hospital 601 W. Second Street Bloomington IN 47403

(812)353-9385

(812)353-5625 Blue Ridge HealthCare 2201 South Sterling Street Morganton NC 28655 828-580-6253 Boca Raton Community Hospital 800 Meadows Road Boca Raton FL 33486 561.955.4442 561.955.3244 Bon Secours—Memorial Regional Medical Center 5801 Bremo Road Suite 310, North Medical Office Building Richmond VA 23226 804-281-8496 Bon Secours St Francis Medical Center 13701 Centerpointe Parkway Midlothian VA 23114 804-594-3247 Bon Secours St. Marys Hospital 5801 Bremo Road Suite 310, North Medical Office Building Richmond VA 23226 804-281-8496 804-287-7310 Boone Hospital Center 1600 E. Broadway Columbia MO 65201-5897 573-815-6068 573-815-8377 Borgess Medical Center 1521 Gull Road Kalamazoo MI 49048 269-226-8261 269-226-7401 Boston Medical Center One Boston Medical Place Boston MA 617-638-7298 Botsford Hospital 28050 Grand River Avenue Farmington Hills MI 48336 248-615-7481 248-471-4400 Braddock Campus 900 Seton Drive Cumberland MD 21502-1850 301-723-6291 301-723-5061 Brandon Regional Hospital 119 Oakfield Drive Brandon FL 33511 813-571-5108 813-571-5221 Brandon Regional Hospital 119 Oakfield Drive Attn: CCL Brandon FL 33511 813-571-5164 813-571-5221 Bromenn Hospital PO Box 2850 Bloomington IL 61702-2850 309-268-5318 Bronson Methodist Hospital 601 John Street Kalamazoo MI 49007-5348 269-341-7567 269-341-8330 Brookdale Hospital & Medical Center 1 Brookdale Plaza Brooklyn NY 11212 718-240-6204 718-240-6516 Brooksville Regional Hospital 17240 Cortez Boulevard Brooksville FL 34601 352-544-6034 Bryan LGH Medical Center 1600 South 48th Street Lincoln NE 68526 402-481-8103 Bryn Mawr Hospital Suite 557 Lankenau MOB East 100 Lancaster Avenue Wynnewood PA 19096 610-526-8661 Buffalo General Hospital/Aaron Health Sciences Library 4D 100 High Street Buffalo NY 14203 746-859-1080 716-859-3765 Cabell Huntington Hospital 1340 Hal Greer Boulevard Huntington WV 25701 304-526-6375 304-526-6377 California Pacific Medical Center 2330 Clay Street, Stern Building, Room #103 Stern Building, Room #103 San Francisco CA 94115 415-600-3473 415-600-5955 CAMC Teays Valley Hospital 1400 Hospital Drive Hurricane WI 25526 304-757-1738 304-757-1875 Camden-Clark Memorial Hospital 800 Garfield Avenue Parkersburg WV 26101 304-424-2851 304-424-2805 Candler Hospital, Inc. 5353 Reynolds Street Savannah GA 31405 912-819-5291 Cape Canaveral Hospital 701 West Cocoa Beach Causeway Cocoa Beach FL 32931 321-868-7612 Cape Cod Hospital 40 Quinlan Way Hyannis MA 02601

(508)862-5723 Cape Fear Valley Health System 303 Wagoner Drive Fayetteville NC 28303-4646 910-609-6552 910-609-7157 Capital Regional Medical Center *barbara.scott3@hcahealthcare.com* Tallahassee FL 32308 850-325-5181 Capital Regional Medical Center 1125 Madison Street (PO Box 1128) Jefferson City MO 65102-1128 573-632-5996 573-632-5999 Cardiovascular Center of Puerto Rico PO Box 366528 San Juan PR 00936-6528 787-754-8500 x3058 Carilion Roanoke Memorial Hosp Att: Cardiac Cath Lab PO Box 13367 Roanoke VA 24033-3367 540-981-8929 540-981-7010 Caritas Norwood Hospital 800 Washington Street Norwood MA 02062 781-278-6241 781-255-7351 Caritas St. Elizabeths Med Center 736 Cambridge Street Boston MA 02135 614-789-3184 617-779-6051 Carle Foundation Hospital 611 W. Park Street Urbana IL 61801 217-383-4749 Carolina Pines Regional Medical Center 1304 W BoBo Newsom Highway Hartsville SC 29550 843-339-4726 843-339-4728 Carolinas Hospital System 805 Pamplico Highway Florence SC 29505 843-674-2610 843-674-2683 Carolinas Medical Center PO Box 32861 Charlotte NC 28232 704 355-7914 Carolinas Medical Center—Mercy 2001 Vail Avenue Cath Lab Charlotte NC 28207 704-304-5495 704-304-6132 Carondelet Heart Institute at St. Joseph Medical Center 1000 Carondelet Drive Kansas City MO 64114 816-943-2732 Carroll Hospital Center 200 Memorial Avenue Westminster MD 21157 410-871-7194 Carson Tahoe Regional Medical Center 1600 Medical Parkway Carson City NV 89706 775 445-8844 Cartersville Medical Center PO Box 20008 Cartersville GA 30120 678-721-5582 770-606-2204 Casa Grande Regional Medical Center 1800 E. Florence Boulevard Casa Grande AZ 85222 520-381-6332 520-381-6621 Catawba Valley Medical Center 810 Fairgrove Church Road Hickory NC 28602 828-326-3863 828-326-3191 Catholic Medical Center 100 McGregor Street Level C Room 248 Manchester NH 03102-3770 603-663-6971 603-663-6390 Cayuga Medical Center at Ithaca 101 Dates Drive Ithaca NY 14850 607-274-4590 607-274-4588 Cedars-Sinai Health Systems 8700 Beverly Boulevard MGB 901 Los Angeles CA 90048 310-423-9663 310-423-9668 Centennial Medical Center 12505 Lebanon Boulevard Frisco TX 75035 972-963-3168 Centennial Medical Center 2300 Patterson Street Nashville TN 37203 Centerpoint Medical Center 19600 E. 39th Street Independence MO 64057 816 698-7152 816 698-7151 Centinela Hospital Medical Center 555 E. Hardy Street Inglewood CA 90301 Central Baptist Hospital 1800 Nicholasville Road Suite 401 Lexington KY 40503 859-260-6763 859-260-6320 Central DuPage Hospital 25 N. Winfield Road Winfield IL 60190 630-933-6922 Central Florida Regional Hospital 1401W. Seminole Boulevard Sanford FL 32771 407.321.4500 x5372 407-324-2155 Central Maine Medical Center 300 Main Street Lewiston ME 04240 207-795-0111 x3752 207-753-3903 Central Minnesota Heart Center at St. Cloud Hospital 1406 Sixth Ave. North St. Cloud MN 56303 320-251-2700 x52627 320-255-5847 Central Mississippi Medical Center 1850 Chadwick Drive Jackson MS 39204 601-376-2826 601-376-1205 Chandler Regional Medical Center 475 S. Dobson Road Quality Management Department Chandler AZ 85224 480-728-3877 602-798-0771 Charleston Area Medical Center 501 Morris Street Charleston WV 25301 304-388-7980 304-388-7979 Charlotte Regional Medical Center 809 East Marion Avenue Punta Gorda FL 33950 941-637-2439 941-637-2452 Charlton Memorial Hospital 363 Highland Avenue Fall River MA 02720-3700 508-679-7159 508-679-7147 Chattanooga-Hamilton County Hospital Authority/ER 975 E. Third Street Chattanooga TN 37403 423-778-4027 423-778-6001 Chesapeake General Hospital 736 Battlefield Boulevard North Chesapeake VA 23320 757-312-5250 Cheshire Medical Center 580 Court Street Keene NH 03431 603-354-5454 ext. 3588 Chester County Hospital 701 East Marshall Street West Chester PA 19380 610-738-2817 610-738-2579 Chester River Hospital Center 100 Brown Street Chestertown MD 21620 410-778-3300 Cheyenne Regional Medical Center Cheyenne Regional Medical Center 214 E. 23rd Street Cheyenne WY 82001 307-633-6053 307 633-6057 Christian Hospital 11133 Dunn Road St Louis MO 63136 314-653-5914 Christiana Care Health System 4755 Ogletown-Stanton Road Newark DE 19718 1-302-733-5417 Christus Hospital—St. Mary 3600 Gates Boulevard Port Arthur TX 77642 409-989-5255 409-989-5197 Christus Saint Elizabeth Hospital 2830 Calder Street Beaumont TX 77702 409-924-6947 409-899-7010 Christus Santa Rosa Hospital 2827 Babcock Road San Antonio TX 78229 Christus Spohn Hospital Corpus Christi—Shoreline 600 Elizabeth Street Corpus Christi TX 78404 361-881-3000 X17311 Christus St. Michael Health System 2600 St. Michael Drive Texarkana TX 75503 903-614-2507 903-614-6925 Christus St. Patrick Hospital 524 South Ryan Street Lake Charles LA 70602-3401 337-430-5464 337-491-7535 Christus—St. Frances Cabrini Hospital 3330 Masonic Drive Cath Lab Alexandria LA 71301 318-448-6992 318-448-4926 Citrus Memorial Health System 502 W. Highland Boulevard Inverness FL 34452 352-344-6421 352-726-6729 CJW Medical Center 7101 Jahnke Road Richmond VA 23225-4044 (804)228-6723 (877)850-1735 Clarian Health Partners—Methodist Hospital campus 1701 N. Senate Boulevard Room A1082 Indianapolis IN 46202 317-962-3583 317-962-5360 Clarian North Medical Center 11725 Illinois Street B-178 Carmel IN 46032 317-688-3014 317-688-2704 Clark Memorial Hospital 1220 Missouri Avenue Jeffersonville IN 47130 812-283-2284 Clear Lake Regional Medical Center 500 Medical Center Boulevard Webster TX 77598 281-338-3879 281-338-3843 Cleveland Clinic Florida 3100 Weston Road Weston FL 33331 954-689-5265 954-689-5297 Cleveland Clinic Foundation 9500 Euclid Avenue Cleveland OH 44195 216-444-9214 216-445-7326 Coliseum Medical Centers 350 Hospital Drive Macon GA 31217 478-464-1641 478-464-1642 College Station Medical Center 1604 Rock Prairie Road College Station TX 77845 979-680-5337 979-764-5108 Columbia Hospital 2025 E. Newport Avenue Milwaukee WI 53211 414-961-5004 414-961-5542 Columbia Regional Hospital 404 Keene Street Columbia MO 65201 573-875-9406 573-875-9090 Columbia St. Mary's Hospital Milwaukee 4425 N. Port Washington Road Milwaukee WI 53212 414-326-2390 414-326-2395 Columbia St. Mary's Hospital Ozaukee 13111 N. Port Washington Road Mequon WI 53097 414-326-2390 414-326-2395 Columbus Regional Hospital 2400 17th Street Columbus IN 47201 812-375-3840 812-375-3833 Comanche County Memorial Hospital 3401 W. Gore Boulevard PO Box 129 Lawton OK 73505 580-585-5587 Community Health Partners 3700 Kolbe Road Lorain OH 44053 440-960-3495 Community Hospital 2615 E. High Street Springfield OH 45505 937-328-9319 937-328-8788 Community Hospital The Community Hospital 901 MacArthur Boulevard Munster IN 46321 219-836-4501 219-852-6436 Community Hospital and Wellness Center 433 West High Street Bryan OH 43506 419-636-1131 x1057 419-630-2193 Community Hospital East Cardiovascular Services 1500 North Ritter Avenue Indianapolis IN 46219 317-355-2058 327-351-7866 Community Hospital of the Monterey Peninsula PO Box HH Monterey CA 93942-1085 831-625-4553 831-625-4877 Community Hospital South 1500 N. Ritter Avenue Indianapolis IN 46219-3027 317-355-2058 Community Medical Center 2827 Fort Missoula Road Missoula MT 59804 406 327-4646 406 327-4666 Community Medical Center 1800 Mulberry Street Scranton PA 18510 570-969-8219 Community Medical Center—Clovis 2755 Herndon Avenue Clovis CA 93611 559-324-4747 559-324-4004 Community Memorial Hospital 147 N. Brent Street Ventura CA 93003 805-652-5617 805-585-3046 Community Memorial Hospital W180 N8085 Town Hall Road Menomonee Falls WI 53052 414-805-4201 Concord Hospital 250 Pleasant Street Concord NH 03301 603-230-6029 603-228-7342 Condell Medical Center 801 S. Milwaukee Avenue Libertyville IL 60048 847-990-5872 847-362-1721 Conroe Regional Medical Center 504 Medical Center Boulevard Conroe TX 77304 936-538-2779 936-538-2649 Covenant Heart Institute 3615 19th Street Lubbock TX 79410 806-825-4553 806-723-7311 Conway Regional Medical Center 2302 College Avenue Conway AR 72034-6226 501-513-5728 501-513-5811 Cookeville Regional Medical Center 142 W. 5th Street Cookeville TN 38501-1760 931-646-2784 931-646-2185 Cooley Dickinson Hospital 30 Locust Street Northampton MA 01060 413-582-4701 413-582-4717 Cooper University Hospital One Cooper Plaza D386B Camden NJ 08103 856-968-7630 Coral Gables Hospital 3100 Douglas Road Coral Gables FL 33134 305-460-1813 305-460-8689 Corpus Christi Medical Center 7101 SPID Corpus Christi TX 78412 361-761-2738 361-761-2656 County of Santa Clara 751 S. Bascom Avenue San Jose CA 95128 408-885-4362 408-793-5820 Covenant Healthcare 1447 N. Harrison Street Saginaw MI 48602 989 583-6544 Covenant Medical Center 3421 West Ninth Street. Waterloo IA 50702 319 272-5171 319-272-7536 Cox Medical Center South 3801 S. National Avenue Springfield MO 65807 417-269-6241 417-269-4995 Craven Regional Medical Center 2000 Neuse Boulevard PO Box 12157 New Bern NC 28560 252-633-8236 252-633-8271 Creighton University Medical Center 601 N. 30th Street Omaha NE 68131 402-449-4078 402-449-4475 Crestwood Medical CenterTriad Hospitals, Inc One Hospital Drive Huntsville AL 35801-3495 256-429-5628 Crittenton Hospital Medical Center 1101 W. University Drive Rochester MI 48307-1831 248.652.5612 248.652.5879 Crouse Hospital 736 Irving Avenue Syracuse NY 13210 315-470-7122 315-470-2958 Crozer Chester Medical Center 1 Medical Center Boulevard Chester PA 19013-3995 610-447-2306 610-447-2924 CVPH Medical Center 75 Beekman Street Plattsburgh NY 12901 518-562-7798 518-562-7795 Cypress Fairbanks Medical Center 10655 Steepletop Drive Houston TX 77065 281-897-3544 281-897-3543 Dameron Hospital 525 W. Acacia Street Stockton CA 95203 209-242-7027 209-461-7534 Danbury Hospital 24 Hospital Avenue Cardiology 2 South Danbury CT 06810 203-739-6945 203-739-1667 Davis Hospital 1600 West Antelope Drive Layton UT 84041 801-807-7270 Davis Regional Medical Center 218 Old Mocksville Road Stateville NC 28625 704-838-7082 Dayton Heart Hospital 707 S. Edwin C. Moses Boulevard Dayton OH 45408 937-221-8056 937-221-8001 DCH Regional Medical Center 809 University Boulevard E Tuscaloosa AL 35401-2029 205-759-7346 205-343-8234 Deaconess Billings Clinic 2800 9th Avenue, North Billings MT 59101 406-657-4336 406-657-3843 Deaconess Hospital 311 Straight Street Cincinnati OH 45219 513-559-2265 Deaconess Hospital 5501 N. Portland Avenue Oklahoma City OK 73112 405 604-4166 Deaconess Hospital 600 Mary Street Evansville IN 47747 812-450-7460 812-450-7258 Deaconess Medical Center W. 800 Fifth Avenue Spokane WA 99204 509-473-7303 Deborah Heart & Lung Center 200 Trenton Road Browns Mills NJ 08015 609-893-1200 x5800 609-893-5953 Decatur General Hospital 1201 7th Street Decatur AL 35601 256-341-2890 Degraff Memorial Hospital 100 High Street Buffalo NY 14203 716-859-1080 716-859-3765 Dekalb Regional Medical Center 200 Medical Center Drive Fort Payne AL 35968 256-997-2158 Del Sol Medical Center 10301 Gateway West El Pasoq TX 79925 915-595-9632 915-595-9633 Delray Medical Center 5352 Linton Boulevard Delray Beach FL 33484 561-594-3278 561-495-3467 Delta Regional Medical Center 1400 E. Union Street Greenville MS 38702 662-725-2053 Denton Regional Medical Center 3535 South I-35E Denton TX 76205 940-384-3875 940-384-4707 Denver Health Medical Center 777 Bannock Street Denver CO 80204 303-436-5651 303-436-7739 DePaul Health Center 12303 DePaul Drive Bridgeton MO 63044 314-344-6790 Des Peres Hospital 2345 Dougherty Ferry Road St. Louis MO 63122 314-966-9468 Desert Regional Medical Center 1150 N. Indian Canyon Palm Springs CA 92262 760-323-6799 760-323-6725 Desert Springs Hospital 620 Shadow Lane Las Vegas NV 89106 702-388-8494 Desert Valley Hospital 16850 Bear Valley Road Victorville CA 92392 760-241-8000 ext. 8674 760-843-5063 DeTar Hospital 506 E. San Antonio Street Victoria TX 77902 361-788-6991 361-788-6137 Dixie Regional Medical Center 1380 E. Medical Drive St. George UT 84790 435-251-1906 435-251-1950 Doctors Hospital 9440 Poppy Drive Dallas TX 75218 214-324-6355 Doctor's Hospital 3983 I-49 S. Service Road Opelousas LA 70570 337-948-2316 337-948-2216 Doctors Hospital at Renaissance 5501 S. McColl Road Edinburg TX 78539 956 661-7760 Doctors Hospital—Augusta 3651 Wheeler Drive Augusta GA 30909 706-651-6672 Doctors Hospital of Laredo 10700 McPherson Road Laredo TX 78045 956-523-2009 Doctors Hospital of Sarasota 5731 Bee Ridge Roadq Sarasota FL 34233 941-342-1100 Doctors Hospital of Stark 400 Austin Avenue Massillon OH 44646 330 837-7200 Doctors Medical Center 2000 Vale Road San Pablo CA 94806 510-970-5184 Doctors Medical Center 1441 Florida Avenue Modesto CA 95350 209-576-3603 Dominican Santa Cruz Hospital 1555 Soquel Drive Santa Cruz CA 95065 831-462-7243 831-462-7558 Downey Regional Medical Center 11500 Brookshire Avenue Downey CA 90241 562-904-5034 Doylestown Hospital 595 West State Street Doylestown PA 18901 215-345-2928 215-345-2411 DuBois Regional Medical Center 100 Hospital Avenue DuBois PA 15801 814-375-7702 Duke University Hospital Erwin Road DUMC 3943 Durham NC 27710 919-681-4060 Dunn Memorial Hospital 1600 23rd Street Bedford ID 47421 812-276-1370 812-276-1034 Durham Regional Hospital 3634 Roxboro Road Durham NC 27704 919-470-6344 East Alabama Medical Center 2000 Pepperall Parkway Opelika AL 36830 334-528-1748 334-528-1764 East Georgia Regional Medical Center 1499 Fair Road (PO Box 1048) Statesboro GA 30459 912-486-1530 East Jefferson General Hospital 4200 Houma Boulevard Quality Management Department Metairie LA 70006 504-456-8449 504-454-5256 East Ohio Regional Hospital 90 N. 4th Street Martins Ferry OH 43935 740-633-4156 East Texas Medical Center 1000 S. Beckham Avenue Tyler TX 75711 903-535-6397 903-535-6597 Eastern Idaho RMC 3100 Channing Way Idaho Falls ID 83404 208-529-7394 208-529-7092 Eastern Maine Medical Center 489 State Street PO Box 404 Bangor ME 04402-0404 207-973-8160 207-750-2174 Easton Hospital (Northampton Hospital Corp.) 250 South 21st Street Easton PA 18042 610-250-4984

(610)250-4896 Edward Hospital 120 Spalding Drive #205 Naperville IL 60540 630-527-3990 630-527-2888 Eisenhower Medical Center 39000 Bob Hope Drive Rancho Mirage CA 92270 760-674-3811 760-773-4336 El Camino Hospital 2500 Grant Road Mountain View CA 94040 Eliza Coffee Memorial Hospital 603 West College Street Florence AL 35630 256-768-9451 Elkhart General Hospital 600 East Boulevard 3 South Suites Elkhart IN 46514-2499 574-296-6539 574-523-3495 Elliot Hospital 1 Elliot Way Manchester NH 03103 603 663-2959 Ellis Hospital 1101 Nott Street Schenectady NY 12308

(518)243-1943

(518)243-4459 Elmhurst Hospital Center 79-01 Broadway Dept of Cardiology, Suite D-54 Elmhurst NY 11373

(718)334-1192

(718)334-5990 Elmhurst Memorial Hospital Marquardt Memorial Lib 200 Berteau Avenue Elmhurst IL 60126 630-833-1400 x 41431 630-782-0724 EMH Regional Medical Center 630 East River Street Elyria OH 44035 440-329-7486 440-329-7470 Emory Crawford Long Hospital 550 Peachtree Street Atlanta GA 30308 404-686-3671 404-686-3891 Emory Eastside Medical Center 1700 Medical Way (PO Box 587) Snellville GA 30078 770-736-2358 Emory University Hospital 1364 Clifton Road, NE C408 Atlanta GA 30322

(404)727-0750

(404)712-1846 Encino-Tarzana Regional Medical Center 18321 Clark Street Tarzana CA 91356-3501 818-708-5349 818-708-5563 Englewood Hospital & Medical Center 350 Engle Street Englewood NJ 07631 201-894-3636 201 541 2188 Enloe Medical Center 1600 Esplanade Chico CA 95926 530-332-7432 Erie County Medical Center 462 Grider Street Buffalo NY 14215 716-898-5450 Evanston Hospital 2650 Ridge Ave Evanston IL 60201 847-570-2418 Excela Health Westmoreland Hospital 532 West Pittsburgh Street Greensburg PA 15601 724-832-4402 Exempla Good Samaritan Medical Center 2420 W. 26th Avenue Building D Suite 100 Denver CO 80211 303-813-5040 303-813-5055 Exempla Lutheran Medical Center 2420 W. 26th Avenue Building D Suite 140 Denver CO 80211 303-813-5038 Exempla Saint Joseph Hospital 2420 W. 26th Avenue Building D Suite 140 Denver CO 80211 303-813-5040 303-813-5055 Exeter Hospital 5 Alumni Drive Exeter NH 03833 603 580-7484 603-580-7263 Fairfield Cardiac Cath Labs 3000 Mack Road Suite 200 Fairfield OH 45014 513-870-7106 513-603-8478 Fairfield Medical Center 401 N. Ewing Street Lancaster OH 43130 740-687-8496 740-687-8646 Fairview Hospital 18101 Lorain Road #329 Cleveland OH 44111 216-476-7872 216-476-7097 Fairview Park Hospital 200 Industrial Boulevard Dublin GA 31021 478-274-3300 478-274-3191 Fairview Southdale Hospital 6401 France Avenue South Edina MN 55435 952-924-5147 952-924-5012 Faith Regional Health Services 2700 W. Norfolk Avenue Norfolk NE 68701 402-371-4880 402-644-7613 Fawcett Memorial Hospital 21298 Olean Boulevard Port Charlotte FL 33949-4960 941-629-1181 x6816 941-629-5467 FirstHealth Moore Regional Hospital 155 Memorial Drive Pinehurst NC 28374 910-715-1591 910-715-2179 Fisher-Titus Medical Center 272 Benedict Avenue Norwalk OH 44857 419-668-8101 ext. 6475 419-660-2715 Flagler Hospital 400 Health Park Boulevard St. Augustine FL 32086 904-819-4404 ext 3659 Fletcher Allen Health Care 111 Colchester Avenue Burlington VT 05401 802-847-5501 802-847-3031 Flordia Hospital Zephyrhills 7050 Gall Boulevard Zephyrhills FL 33541 813-783-6119 ext 2274 Florida Hospital 220 Winter Park Street Orlando FL 32803 407-303-5600 x3669 407-303-7304 Florida Hospital Ormond Memorial 875 Sterthaus Avenue Ormond Beach FL 32174 386-676-6135 386-671-6671 Florida Hospital Waterman, Inc. 1000 Waterman Way Tavares FL 32778 352-253-3483 352-253-3153 Florida Medical Center 5000 W. Oakland Park Boulevard Lauderdale Lakes FL 33313 954-735-6000 x4309 Flowers Hospital 4370 West Main Street Dothan AL 36305 334-794-5000 x8280 Floyd Medical Center 304 Turner McCall Boulevard Rome GA 30165 706-509-5000 Forest Hills Hospital 102-01 66th Road Forest Hills NY 11375 Forrest General Hospital 6051 Highway 49 South Hattiesburg MS 39404-6389 601-288-2819 601-288-2808 Forsyth Medical Center 3333 Silas Creek Parkway Clinical Improvement Box 102 Winston-Salem NC 27103 336-718-6370 336-277-9269 Fort Sanders Regional Medical Center 1901 Clinch Avenue Knoxville TN 37916-2307 865-541-1414 865-541-2893 Fort Walton Beach Medical Center 1000 Mar Walt Drive Fort Walton Beach FL 32547 850-315-7817 Forum Health—Northside Medical Center 500 Gypsy Lane Youngstown OH 44501-0240 330-884-3021 330-884-5748 Fountain Valley Regional Hosp 17100 Euclid Street Fountain Valley CA 92708-4004 714-966-8043 714-966-3327 Frankford Hospital Knights & Red Lion Roads Philadelphia PA 19114 215-612-4580 215-612-5463 Frankfort Regional Medical Center 299 Kings Daughter Drive Frankfort KY 40601 502-226-7698 502-226-7680 Franklin Square Hospital 9000 Franklin Square Drive Baltimore MD 21237 443-777-7446 Frederick Memorial Hospital 400 W. Seventh Street Frederick MD 21710 240-566-3269 Freeman Hospital 1102 W. 32nd Street Joplin MO 64804 417-347-3066 417-347-3764 Freeport Health Network 1045 W. Stephenson Street Freeport IL 61032 815-599-6384 Fremont Area Medical Center 450 East 23rd Street Fremont NE 68025 402-727-3659 402-727-3688 French Hospital Medical Center 1911 Johnson Avenue St Luis Obispo CA 93401 Fresno Community Hospital and Medical Center 110 N. Valeria Street #103 Fresno CA 93710 559-459-6771 559-459-2358 Fresno Heart Hospital 15 East Audubon Drive Fresno CA 93720 559-433-8026 559-433-8326 Froedtert Hospital 9200 W. Wisconsin Avenue Milwaukee WI 53226 414-769-4201 414-805-4265 Frye Regional Medical Center 420 N. Center Street Hickory NC 28601 828-315-5024 Gadsden Regional Medical Center 1007 Goodyear Avenue Gadsden AL 35903 256-494-4265 Galichia Heart Hospital 2610 N. Woodlawn Boulevard Wichita KS 67220 316-858-2930 316-858-8999 Garden City Hospital 6245 Inkster Road Garden City MI 48135 734-458-3251 734-458-3239 Gaston Memorial Hospital 2525 Court Drive Gastonia NC 28054 704-834-3605 704-834-4678 Gateway Medical Center Gateway Health System 1771 Madison Street Clarksville TN 37043 931-551-1662 Gateway Regional Medical Center 2100 Madison Avenue Granite City IL 62040 618-798-3623 618-798-3579 Geisinger Medical Center 100 North Academy Avenue Danville PA 17822-2160 570-271-5555 x54807 570-271-8056 Geisinger Wyoming Valley Medical Center 100 North Academy Avenue Danville PA 17822-2160 570-271-5555 x54807 570-271-8056 Genesis Medical Center 1236 East Rusholme Street Suite 190 Davenport IA 52803-2459 563-421-3935 563-421-3933 Genesis Medical Center, Illini Campus 801 Illini Drive Silvis IL 61282 309-792-7071 309-792-6424 Genesys Regional Medical Center One Genesys Parkway Grand Blanc MI 48439 810-606-7653 810-606-6668 Georgetown University Hospital 3800 Reservoir Road NW Washington DC 20007 202-444-8619 202-444-3165 Glendale Adventist Medical Center 1509 Wilson Terrace Glendale CA 91206 818-409-8258 818-546-5616 Glendale Memorial Hospital and Health Center 1420 S. Central Avenue Glendale CA 91204 818-502-1900 x4755 818-507-4161 Glens Falls Hospital 100 Park Street Glens Falls NY 12801 518-926-4170 518-926-4169 Good Samaritan Heart Center 520 South 7th Street Vincennes IN 47591 812-885-3964 812-885-3915 Good Samaritan Hospital and Health Center 2222 Philadelphia Drive Dayton OH 45406 937-278-6251 x2256 937-341-8691 Good Samaritan Hospital 2425 Samaritan Drive 2425 Samaritan Drive San Jose CA 95124 408-559-2189 408-559-2692 Good Samaritan Hospital 605 N. 12th Street Mount Vernon IL 62864 618-241-4438 618-241-3853 Good Samaritan Hospital 3815 Highland Avenue Downers Grove IL 60515 630-275-1403 603-275-5713 Good Samaritan Hospital 375 Dixmyth Avenue Cincinnati OH 45220-2489 513-872-4893 513-872-4897 Good Samaritan Hospital 1225 Wilshire Boulevard Los Angelos CA 90017 213-977-4058 213-977-2371 Good Samaritan Hospital 10 East 31 Street Kearney NE 68848 308-865-7516 308-865-2918 Good Samaritan Hospital 255 Lafayette Avenue Suffern NY 10901 845-368-5915 845 368 8250 Good Samaritan Hospital Cardiology 1000 Montauk Highway West Islip NY 11795 631-376-4090 631-376-4061 Good Samaritan Hospital of Maryland 5601 Loch Raven Boulevard Baltimore MD 21239 410-532-4570 410-532-4572 Good Samaritan Medical Center 1309 North Flagler Drive West Palm Beach FL 33401 561-671-7444 561-650-6186 Good Samaritan Regional Medical Center 3600 NW Samaritan Drive Corvallis OR 97330 541-768-5265 541-768-4776 Good Shepherd Medical Center 700 East Marshall Avenue Longview TX 75601 903-315-5118 Governor Juan F. Luis Hospital & Medical Center 4007 Estate Diamond Ruby Christiansted VI 00820 340-778-6311 340-772-7414 Grady Memorial Hospital 561 West Central Avenue Delaware OH 43015-1489 740-368-5286 Grandview Medical Center 405 Grand Avenue Dayton OH 45405 937-723-3335 Grant Medical Center 111 S. Grant Avenue Columbus OH 43215 614-566-9474 Great Plains Regional Medical Center Box 2339 Elk City OK 73648 580-225-2511 580-821-5541 Greater Baltimore Medical Center GBMC—Cardiac Cath Lab 6701 N. Charles Street Towson MD 21204 443-849-2269 443-849-8154 Greenville Memorial Hospital 701 Grove Road Greenville SC 29605 864-455-6464 864-455-4775 Greenwich Hospital 5 Perryridge Road Greenwich CT 06830 203-863-3689 Gulf Coast Medical Center 449 W. 23rd Street Panama City FL 32406-5309 850-747-7896 Gulf Coast Medical Center 1400 Highway 59 Wharton TX 77488 979-282-6115 979-282-6163 Gundersen Lutheran Medical Center, Inc. 1900 South Avenue H06-004 LaCrosse WI 54601 608-775-6398 608-775-4802 Gwinnett Hospital System 1000 Medical Center Boulevard Lawrenceville GA 30045 678-442-4534 Hackensack University Medical Center 30 Prospect Avenue Hackensack NJ 07601 201-996-2663 Hackley Hospital General Fund 1700 Clinton Street Muskegon MI 49443 231-728-4629 231-728-5781 Hahnemann University Hospital 230 N. Broad Street Philadelphia PA 19102 215-762-2049 Halifax Medical Center 303 N. Clyde Morris Boulevard Daytona Beach FL 32114-2732 386-756-2143 386-254-2934 Halifax Regional Hospital 2204 Wilborn Avenue South Boston VA 24592 434-517-3457 434-517-3168 Hamilton Medical Center 1200 Memorial Drive Dalton GA 30720 706-272-6022 706-272-6341 Hamot Medical Center 201 State Street Erie PA 16550 814-877-2960 814-877-5696 Hannibal Regional Hospital 6000 Hospital Drive Hannibal MO 63401 573-248-5290 Harbor Hospital Center 3001 S. Hanover Street Baltimore MD 21225 410-350-3898 Hardin Memorial Hospital 913 N Dixie Avenue Elizabethtown KY 42701 270-706-1159 270-706-1159 Harlingen Medical Center 5501 South Expressway 77 Harlingen TX 78550 956-365-1140 956-365-1875 Harper University Hospital 3990 John R. Street Detroit MI 48201 313-745-8349 319-966-5130 Harris Methodist Fort Worth 1301 Pennsylvania Avenue Fort Worth TX 76104 817-250-2780 817-250-2752 Harris Methodist HEB 1600 Hospital Parkway Bedford TX 76022 817-685-4081 Harrison Medical Center 2520 Cherry Avenue Bremerton WA 98310 360-792-6808 Hartford Hospital 80 Seymour Street Hartford CT 06102-8000 860-545-1522 860-545-3557 Harton Regional Medical Center 1801 N. Jackson Street Tullahoma TN 37388 931-393-7933 Havasu Regional Medical Center 101 Civic Center Lane Lake Havasu City AZ 86403 928-453-0806 928-453-0807 Hawaii Medical Center East, LLC 2230 Liliha Street Honolulu HI 96817 808-547-6434 808-547-6351 Hawaii Medical Center West 91-2141 Fort Weaver Road Ewa Beach HI 96706 808-678-7150 808-678-7163 Hays Medical Center 2220 Canterbury Road Hays KS 67601 785-623-5051 785-623-5052 Hazard ARH Regional Medical Center 100 Medical Center Drive Hazard KY 41701 606-439-6827 Health Care Authority for Baptist Health 2105 East South Boulevard Montgomery AL 36116 334-286-3327 334-286-2364 Heart and Lung Clinic 900 East Broadway Box 5510 Bismarck ND 58502 701-530-7506 701-530-7494 Heart Center of Indiana 8333 Nabb Road Suite 330 Suite 330 Indianapolis IN 46290 317-338-6012 317-338-6214 Heart Hospital of Austin 3801 N. Lamar Boulevard Austin TX 78756 512-407-7497 Heart Hospital of Lafayette 1105 Kaliste Saloom Road Lafayette LA 70508 337-521-1025 337-521-1006 Heart Hospital of New Mexico 504 Elm Street NE Albuqerque NM 87102 505-724-2029 Heart of Florida Regional Medical Center 40100 Highway 27 Davenport FL 33837 863-419-2330 Heartland Regional Medical Center 3333 W. Deyoung Street Marion IL 62959 618-998-7491 Heartland Regional Medical Center The Heart Center—Cardiac Cath Lab 5325 Faraon Street Saint Joseph MO 64506-3373 816-271-6665 816-271-1077 Helen Ellis Memorial 1395 South Pinella Avenue Tarpon Springs FL 34689 727-942-5110 Hellen Keller Hospital 1300 South Montgomery Avenue Sheffield AL 35660 256-386-4194 256-386-4687 Hemet Valley Medical Center 1117 E. Devonshire Avenue Hemet CA 92543

(951)652-2811 Hendersonville Medical Center 355 New Shackle Island Road Hendersonville TN 37075 615-338-1450 615-338-1455 Hendrick Medical Center 1900 Pine Street Abilene TX 79601 915-670-2000 Hennepin County Medical Center 701 Park Avenue Minneapolis MN 55415-1829 612-873-3349 612-904-4222 Henrico Doctors Hospital 1602 Skipwith Road Cardiac Cath Lab Richmond VA 23229 804-289-5633 804-285-5143 Henry Ford Hospital 2799 W. Grand Boulevard K-14 Detroit MI 48202 313-916-4905 313-916-1249 Henry Ford Macomb 15855 Nineteen Mile Road Clinton Township MI 48038 586 263 2108 586 263 2925 Henry Ford Macomb-Warren 13355 East Ten Mile Road Warren MI 48089 586-759-7400 Henry Mayo Newhall Memorial Hospital 23845 McBean Parkway Valencia CA 91350 661-253-8023 661-253-8142 Henry Medical Center, Inc 1133 Eagles Landing Parkway Stockbridge GA 30281 678-604-5027 678-604-5071 Hialeah Hospital 651 East 25th Street Hialeah FL 33013 305-835-4136 305-835-4355 High Point Regional Hospital 601 N. Elm Street High Point NC 27261 336-878-6006 Highland Park Hospital 718 Glenview Avenue Highland Park IL 60035 847-480-2641 847-926-5332 Highlands Regional Medical Center 3600 S. Highlands Avenue Sebring FL 33870 863-381-6101 Highlands Regional Medical Center 5000 US 321 Prestonburg KY 41653 606-886-7481 606-886-7799 Hillcrest Baptist Medical Center 3000 Herring Avenue Waco TX 76708 254-202-6849 254-202-5609 Hillcrest Hospital 6780 Mayfield Road Mayfield Heights OH 44124 440-312-8573 440-312-6929 Hillcrest Medical Center 1120 S. Utica Avenue 3 West Tulsa OK 74104 918-579-3396 918-579-5355 Hilton Head Regional Medical Center 25 Hospital Center Boulevard Hilton Head SC 29925 843-689-8359 Hinsdale Hospital 120 N. Oak Street Hinsdale IL 60521 630-856-6164 HMA-Physician Management Region 25 Disb. Acct. (Physician's Regional) 6101 Pine Ridge Road Naples FL 34119 239-304-4733 Hoag Memorial Hospital Presbyterian One Hoag Drive Newport Beach CA 92658 949-764-6813 949-764-1492 Holland Community Hospital 602 Michigan Avenue Holland MI 49423 616-394-3596 616-394-4207 Holmes Regional Medical Center 1355 South Hickory Street Suite 203 Melbourne FL 32901 321-434-1266 321-434-7124 Holy Cross Hospital 4725 N. Federal Highway Ft. Lauderdale FL 33308 954-229-7968 954-267-6696 Holy Cross Hospital 2701 W. 68th Street Chicago IL 60629 773-884-7752 773-884-8004 Holy Cross Hospital Medical Library 1500 Forest Glen Road Silver Spring MD 20910 301-754-7389 301-754-7386 Holy Spirit Health System 503 N 21st Street Heart Center Administration Camp Hill PA 17011-2204 717-972-4745 717-972-7581 Hospital of St. Raphael Cardiac Cath Lab, 1450 Chapel Street New Haven CT 06511 203-789-3460 203-867-5204 Hospital of the University of Pennsylvania 9011 E. Gates 3400 Spruce Street Philadelphia PA 19104 215-662-7781 215-349-5799 Houston Northwest Medical Center Accounts Payable 710 FM 1960 Road West Houston TX 77090 281-440-2886 Howard County General Hospital 5755 Cedar Lane Columbia MD 21044 410-884-4544 410-884-4677 Howard University Hospital 2041 Georgia Avenue NW Washington DC 20060 202-865-6835 202-865-4449 Huguley Memorial Medical Center 11801 S. Freeway Ft. Worth TX 76115 817-551-2542 817-551-2568 Huntington Hospital 100 W. California Boulevard Pasadena CA 91109 626-397-2229 626-397-2191 Huntington Hospital 270 Park Avenue Huntington NY 11743 631-351-2798 631-351-4115 Huntsville Hospital 101 Sivley Road Huntsville AL 35801 256-265-2552 256-265-2291 Hutchinson Hospital 1701 E. 23rd Avenue Hutchinson KS 67502 620-665-2061 Iberia Medical Center 2315 East Main Street New Iberia LA 70560 337-374-7192 Immanuel—St. Joseph's Hospital 1025 Marsh Street Mankato MN 56001 507-317-4328 507-389-4774 Indian River Medical Center 1000 36th Street Vero Beach FL 32960 772-567-4311 x1810 Indiana Heart Institute 8333 Naab Rd, Suite 330 Indianapolis IN 46260 317-338-6500 317-338-6214 Indiana Regional Medical Center Cardiology Department 835 Hospital Road Indiana PA 15701 724-357-8035 724-357-8038 Ingalls Hospital One Ingalls Drive Harvey IL 60426 708-333-2300 708-915-3114 Ingham Regional Medical Center 401 W. Greenlawn Avenue Lansing MI 48910 517-334-2720 517-367-5676 Innovis Health 3000 32nd Avenue SW Fargo ND 58104 701-364-8263 701-364-8262 Inova Alexandria Hospital 4320 Seminary Road Alexandria VA 22304 703-504-7950 Inova Fairfax Hospital/Inova Heart & Vascular Institute 3300 Gallows Road Falls Church VA 22042 703-208-6694 703-208-6699 Inova Loudoun Hospital 44035 Riverside Parkway Suite 120 Leesburg VA 20176 703-858-8656 703-858-8670 Integris Baptist Medical Center 3433 NW 56th Street, Suite 805 Oklahoma City OK 73112 405-949-3648 Integris Health 600 S. Monroe Street Enid OK 73701 580-548-1111 580-548-1487 Integris Southwest Medical Center 4401 South Western Avenue Oklahoma City OK 73109 405-636-7574 405-231-0559 Intermountain Medical Center PO Box 577000 Murray UT 84157-7000 801-507-2958 801-507-2996 Iowa Lutheran Hospital 700 E. University Avenue Des Moines IA 50316 515-263-5813 515-263-5415 Iowa Methodist Medical Center 700 E. University Avenue Des Moines IA 50316 515-263-5813 515-263-5415 Iredell Memorial Hospital 557 Brookdale Drive Statesville NC 28687 704-878-4691 704-878-4632 Iroquois Memorial Hospital 200 Fairman Avenue Watseka IL 60970 815-432-7720 Irvine Regional Hospital and Medical Center 16200 Sand Canyon Avenue Irvine CA 92618-3701 949-753-2036 949-753-2072 Jackson Hospital and Clinic 1725 Pine Street Montgomery AL 36106 334-293-8881 334-293-8899 Jackson Madison General Hospital 708 West Forrest Avenue Jackson TN 38301 731-541-6326 731-425-6749 Jackson Memorial Hospital 1611 N.W. 12th Avenue Miami FL 33136 305-585-5084 305-585-2551 Jamaica Hospital Medical Center 8900 VanWyck Expressway Jamaica NY 11418 718 206-6191 718 206-7148 Jane Phillips Memorial Medical Center 3500 Frank Phillips Boulevard Bartlesville OK 74006 918-331-1101 918-331-1156 Jeanes Hospital 7600 Central Avenue Philadelphia PA 19111 215-728-2378 Jeff Anderson Regional Medical Center 2124 14th Street Meridian MS 39301 601-553-6611 Jefferson Memorial Hospital PO Box 350 Crystal City MO 63019 636-933-5412 636-933-5717 Jefferson Regional Medical Center 1600 West 40th Avenue Pine Bluff AR 71603 870-541-4012 Jefferson Regional Medical Center PO Box 18119 565 Coal Valley Road Pittsburgh PA 15236-0119 412-469-7205 412-469-7689 Jersey City Medical Center 355 Grand Street Neptune NJ 07307 201-915-2206 201-915-2113 Jersey Shore University Medical Center 1945 State Route 33 Neptune NJ 07753 732-776-2956 732-776-4324 Jewish Hospital 4777 East Galbraith Road Cincinnati OH 45236 513-686-3188 513-686-4454 Jewish Hospital 200 Abraham Flexner Way Louisville KY 40202 502-587-4847 502-560-8570 JFK Medical Center 5631 Glencrest Boulevard Tampa FL 33625-1008 813-265-0997 813-265-1244 John C. Lincoln Hospital—Deer Valley 19829 N. 27th Ave. Phoenix AZ 85027-4002 602-870-6060 x3202 John C. Lincoln Hospital—North Mountain 250 E. Dunlap Avenue Phoenix AZ 85020-2871 602-870-6060 x3202 John F. Kennedy Memorial Hospital 47-111 Monroe Street Indio CA 92201 760-775-8086 760-775-8454 John Muir Medical Center—Concord Campus 2540 East Street Concord CA 94520 925-674-2466 John Muir—Walnut Creek 1601 Ygnacio Valley Road Walnut Creek CA 94550 925-941-7951 925-941-7961 Johns Hopkins Bayview Medical Center 4940 Eastern Avenue Baltimore MD 21224 410-550-3557 410-550-3384 Johns Hopkins Hospital 600 N. Wolfe Street Baltimore MD 21287 410-502-0396 410-614-4243 Johnson City Medical Center Hosp 400 N State of Franklin Johnson City TN 37604 423-431-5690 Jordan Valley Hospital 3580 W. 9000 S West Jordan UT 84088 801-562-3188 Kadlec Medical Center 888 Swift Boulevard Richland WA 99352 509-942-2149 509-942-2750 Kaiser Foundation Hospital 1526 Edgemont Street Los Angeles CA 90027 323-783-6623 323 783 7819 Kaiser Foundation Hospital 6600 Bruceville Road Sacramento CA 95823 916-688-2287 916-688-6684 Kaiser Permanente—Moanalua Medical Center 3288 Moanalua Road Honolulu HI 96819 808-432-0000 Kaiser Permanente Medical Center—Santa Clara 710 Lawrence Expressway Santa Clara CA 95051 408-851-3749 408-851-3862 Kaiser Permanente Medical Center Health Sciences Library 9400 E. Rosecrans Avenue Bellflower CA 90706 562-461-5679 562-461-4487 Kaiser Permanente Walnut Creek 4647 Zion Avenue Bellflower CA 92120 619-528-3851 619-528-7141 Kaiser Sunnyside Medical Center 10180 SE Sunnyside Road Clackamas OR 97015 503-571-6522 503-571-6560 Kansas Heart Hospital 3601 N Webb Road Wichita KS 67226 316-630-5369 316-630-5388 Kansas Heart Hospital 3601 N Webb Road Wichita KS 67226 316-630-5369 Kansas University Hospital Authority 3901 Rainbow Boulevard Kansas City KS 66160 913-588-9731 913-588-9773 Kapi'olani Medical Center Pali Momi 98-1079 Moanalua Road Aiea HI 96701 808-485-4374 808-485-4400 Kaweah Delta Hospital District Kaweah Delta Hospital District 400 W. Mineral King Avenue Visalia CA 93291 559-624-5524 559-635-4065 Kershaw County Medical Center 1315 Roberts Street Camden SC 29020 803-713-6887 803-713-6324 Kettering Medical Center 3535 Southern Boulevard Kettering OH 45429 937-298-3399 x57407 937-395-8647 Kingman Regional Medical Center 3269 Stockton Hill Road Kingman AZ 86401 928-757-0619 928-692-1418 Kings Daughters Hospital 1901 Southwest H.K. Dodgen Loop Temple TX 76502 254-742-2111 254-742-9205 Kings Daughters Medical Center 2201 Lexington Avenue Ashland KY 41101 606-326-6072 606-327-5107 Kingwood Medical Center 22999 Highway 59 N Kingwood TX 77339 281-348-8361 281-348-8390 Knox Community Hospital 1330 Coshocton Road Mount Vernon OH 43050 740-393-9058 740-399-3113 Kootenai Medical Center 2003 Lincoln Way Coeur d' Alene ID 83814 208-666-2189 208-666-2596 Kuakini Medical Center 347 North Kuakini Street Cardiac Cath Lab Honolulu HI 96817 808-547-9602 808-547-9604 Labette Health 1920 S. US Highway 59 PO BOX 956 Parson KS 67357 620-820-5230 Lafayette General Medical Center 1214 Coolidge Avenue Lafayette LA 70505 337-289-8674 337-289-7169 LaGrange Memorial Hospital 120 North Oak Street Hinsdale IL 60521 630-856-6164 630-856-6129 Lahey Clinic 41 Mall Road Burlington MA 01805 781-744-1083 781-744-5577 Lake Charles Memorial Hospital 1701 Oak Park Boulevard Lake Charles LA 70601 337-494-2972 337-430-6954 Lake Pointe Medical Center 6800 Scenic Drive Rowlett TX 75088 972-348-8773 X1711 972-463-7456 Lake Regional Health System 54 Hospital Drive Osage Beach MO 65065 573-348-8773 or 573-348-8225 573-348-8266 Lakeland Hospital 1234 Napier Avenue Saint Joseph MI 49085-2112 616-982-4851 616-983-8232 Lakeland Regional Medical Center 1324 Lakeland Hills Boulevard Lakeland FL 33804 863-687-1100 x3318 863-413-5904 Lakeside Hospital 6901 N. 72nd Street Suite 3300 Omaha NE 68122 402-572-2689 402-572-2371 Lakeview Regional Medical Center 95 East Fairway Drive Covington LA 70433-7500 985-867-4080 985-867-4081 Lakeway Regional Hospital 726 McFarland Street Morristown TN 37814 423-522-6024 423-587-8548 Lakewood Hospital 14519 Detroit Avenue Lakewood OH 44107 216-227-2422 Lakewood Ranch Medical Center 8330 Lakewood Ranch Boulevard Bradenton FL 34202 941-782-2273 941-782-2556 Lakewood Regional Medical Center 3700 East South Street Lakewood CA 90712 562-272-6456 Lancaster Community Hosp 43830 North 10th Street West Lancaster CA 93534 661-940-1416 661-940-1483 Lancaster General Hospital 555 N. Duke Street PO Box 3555 Lancaster PA 17604-3555 717-544-4799 Lancaster Regional Medical Center 250 College Avenue Lancaster PA 17604 717-291-8232 717-291-8397 Lane Regional Medical Center 6300 Main Street Zachary LA 70791 225-658-4504 Lankenau Hospital Suite 557 Lankenau MOB East 100 Lancaster Avenue Wynnewood PA 19096 610-526-8661 Laredo Medical Center 1720 Bustamante Street Laredo TX 78044 956-796-3309 Largo Medical Center 201 14th Street SW Largo FL 33770 727-588-5560 727-588-5906 Las Colinas Medical Center 6800 North MacArthur Boulevard Irving TX 75039 972-969-2392 469-484-1411 Las Palmas Medical Center 1801 N. Oregon Street El Paso TX 79902 915-521-1478 Lawrence & Memorial Hospital 365 Montauk Avenue New London CT 06375 860-442-0711 x2699 860-442-7203 Lawrence Hospital 55 Palmer Avenue Broxville NY 10708-3491 914-787-3298 Lee Memorial Health System—Cape Coral Hospital 276 Cleveland Avenue Fort Myers FL 33901 239-573-5548 239-573-5542 Lee Memorial Health System—Health Park Med Center 276 Cleveland Avenue Fort Myers FL 33901 239-573-5548 239-573-5542 Lee's Summit Medical Center 2100 SE Blue Parkway Lee's Summit MO 64063 816-282-5582 816-282-5581 Leesburg Regional Medical Center 600 East Dixie Avenue Leesburg FL 34748 352-323-5957 Legacy Emanuel Hospital 1919 NW Lovejoy Street Portland OR 97209 503-415-5518 503-415-5317 Legacy Good Samaritan Hospital 1919 NW Lovejoy Street Portland OR 97209 503-415-5518 503-415-5317 Legacy Meridian Park Hospital 19300 SW 65th Avenue Tualatin OR 97062 503-692-1212 Legacy Salmon Creek Hospital 1919 NW Lovejoy Street Portland OR 97209 503-415-5518 Lehigh Regional Medical Center 1500 Lee Boulevard Lehigh Acres FL 33963 239-368-4470 239-368-4470 Lehigh Valley Hospital 1200 S. Cedar Crest Boulevard Jaindl Pavilion 1st Floor Allentown PA 18103 610-402-0601 610-402-8613 Lehigh Valley Hospital—Muhlenberg 2545 Schoenersville Road Invasive Cardiology 3rd Floor Bethlehem PA 18017-7330 610-402-0601 Lenox Hill Heart and Vascular Institute of New York 100 East 77th Street New York NY 10021 212-434-6984 Lewis Gale Medical Center 1900 Electric Road Salem VA 24153 540-776-4939 540-776-4924 Lexington Medical Center 2720 Sunset Boulevard West Columbia SC 29169 803-791-2105 803-791-2660 Licking Memorial Hospital 1320 W. Main Street Newark OH 43055 740-348-4186 Lima Memorial Hospital 1001 Bellefontaine Avenue Lima OH 45804 419-998-4650 419-226-5133 Lincoln Park Hospital 550 W. Webster Avenue Chicago IL 60614 773-883-3672 773-883-3821 Little Company of Mary Hospital 4101 Torrance Boulevard Torrance CA 90503 310-303-5514 806-313-5514 Little Company of Mary Hospital 2800 W. 95th Street Evergreen Park IL 60805 708-229-5593 Logan General Hospital, LLC 20 Hospital Drive Logan WV 25601 304-831-1870 304-831-1840 Loma Linda University Medical Center 11234 Anderson Street Room 2431 Loma Linda CA 92354 909-558-4344 909-558-4249 Long Beach Memorial Medical Center 2801 Atlantic Avenue Long Beach CA 90806 562-933-3739 562-933-3328 Long Island College Hospital 339 Hicks Street Brooklyn NY 11201 718-780-2395 Long Island Jewish Medical Center 270-05 76th Avenue New Hyde Park NY 11040 718-470-4276 718-347-0753 Longmont United Hospital 1950 Moutain View Avenue Longmont CO 80501 303-651-5065 Longview Regional Medical Center PO Box 14000 Longview TX 75607 903-232-3695 Los Alamitos Medical Center 3751 Katella Avenue Los Alamitos CA 90720 562-799-3193 Los Robles Hospital & Medical Center 215 W. Janss Road Thousand Oaks CA 91360-1899 805-370-4585 805-267-8914 Louisiana Medical Center and Heart Hospital 64030 Louisiana Highway 434 Lacombe LA 70445 985-690-7522 985-690-7530 Lourdes Hospital 1530 Lone Oak Road Paducah KY 42003 270-444-2105 270-444-2886 Lovelace Medical Center 601 Dr. Martin Luther King, Jr. Ave NE Albuquerque NM 87106 505-727-8198 Lowell General Hospital 295 Varnum Avenue Lowell MA 01854 978-937-6226 978-937-6913 Lower Bucks Hospital 501 Bath Road Bristol PA 19007 215-785-9447 215-785-9120 Lower Keys Medical Center 5900 College Road Key West FL 33040 305-294-5531 ext 3382 LSUHSC—Cath Lab 1501 Kings Highway Shreveport LA 71130 318-675-7906 318-675-7913 Lubbock Heart Hospital 4810 N. Loop 289 Lubbock LA 79416 806-472-5307 806-472-3894 Luther Hospital 1221 Whipple Street Eau Claire WI 54703 715-838-3788 Lutheran Hospital of Indiana 7950 W. Jefferson Boulevard Fort Wayne IN 46804 260-435-7480 260-435-7632 Lutheran Medical Center 150 55th Street Brooklyn NY 11220 718-630-8396 Lynchburg General Hospital 1901 Tate Springs Road Lynchburg VA 24501-1167 434-947-7173 434-947-4601 MacNeal Hospital 3249 S. Oak Park Avenue Berwyn IL 60402 708-783-3360 708-783-0052 Magnolia Regional Health Center 611 Alcorn Drive Corinth MS 38834 662-293-1359 Maimonides Medical Center Division of Cardiology Division of Cardiology 4802 10th Avenue Brooklyn NY 11219 718-283-7094 718-635-7388 Maine Medical Center 22 Bramhall Street Portland ME 04102 207-662-2661 207-662-6210 Manatee Memorial Hospital 206 Second Street East Bradenton FL 34208 941-745-7572 941-745-6891 Marian Medical Center 1400 East Church Street Santa Maria CA 93454 805-739-3746 Maricopa Integrated Health System 2601 E. Roosevelt Street Phoenix AZ 85008 602-344-5722 602-344-1364 Marin General Hospital 250 Bon Air Road Greenbrae CA 94904 415-925-7797 415-925-7626 Marion General Hospital 441 N. Wabash Avenue Marion IN 46952 765-662-4874 765-662-4548 Marion General Hospital 1000 McKinley Park Drive Marion OH 43302-6397 740-375-6000 740-375-6017 Marquette General Hospital System 580 W. College Avenue Marquette MI 49855 906-225-3536 Martha Jefferson Hospital 459 Locust Avenue Charlottesville VA 22902 434-982-8472 Martin Memorial Medical Center PO Box 9010 Stuart FL 34995 772-221-2094 772-419-2104 Mary Black Hospital 1700 Skylyn Drive Spatanburg SC 29307 864-573-3384 864-573-3274 Mary Greeley Medical Center 1111 Duff Avenue Ames IA 50010 515-239-6980 Mary Hitchcock Memorial Hospital One Medical Center Drive Lebanon NH 03756 603-650-5704 603-650-0523 Mary Washington Hospital 1001 Sam Perry Boulevard Fredericksburg VA 22401 540-741-4140 540-741-2909 Marymount Medical 310 East 9th Street London KY 40741 606-877-6124 606-877-3834 Massachusetts General Hospital 55 Fruit Street Boston MA 02114 617-643-3691 617-726-7519 Maury Regional Hospital 1224 Trotwood Avenue Columbia TN 38401 931-381-1111 x1663 Mayo Clinic Arizona 5777 E. Mayo Boulevard Phoenix AZ 85054 480-342-3005 480-342-2345 Mayo Clinic—St. Mary's Hospital 200 First Street SW Rochester MN 55905 507-284-2111 McAlester Regional Health Center 1 Clark Bass Boulevard McAlester OK 74501 918-421-8087 McAllen Medical Center 301 W. Expressway 83 McAllen TX 78503 956-632-4019 MCG Health Inc. 1120 15th Street BBR-8521 Augusta GA 30912 706-721-1118 706-721-0347 McKay-Dee Hospital Center 4401 Harrison Boulevard Ogden UT 84405 801-387-3000 McKee Medical Center 2000 Boise Avenue Loveland CO 80538 970-635-4118 McLeod Regional Medical Center 555 E. Chaves Street Florence SC 29501 843-777-2101 843-777-5075 Mease Countryside Hospital 3231 Mccullen Booth Road Safety Harbor FL 34695 727-461-8274 Mease Dunedin Hospital 207 Jeffords Street MS 142 Clearwater FL 33756 727-461-8274 727-461-8651 Med Central Mansfield 335 Glessner Avenue Mansfield OH 44903 419-526-8450 419-526-8246 Medcenter One 300 N. 7th Street Bismarck ND 58501 701-323-6529 Medical Center at Bowling Green 250 Park Street Bowling Green KY 42101 270-796-2464 270-796-2462 Medical Center Hospital 500 W. 4th Street Odessa TX 79760 432-640-2262 432-640-2282 Medical Center of Aurora 1501 S. Potomac Street Aurora CO 80012 303-873-5868 303-873-5747 Medical Center of Central Georgia 777 Hemlock Street HB 53 Macon GA 31208 478-633-1977 478-633-4349 Medical Center of Louisiana at New Orleans 1541 Tulane Avenue Room #203 Butterworth Building New Orleans LA 70112 504-903-0857 504-903-2270 Medical Center of McKinney 4500 Medical Center Drive McKinney TX 75069 972-540-4332 972-540-4525 Medical Center of Mesquite 1011 N. Galloway Avenue Mesquite TX 75149 214-319-2829 214-320-7047 Medical Center of Plano 3901 W. 15th Street Plano TX 75075-7738 972-519-1341 972-519-1214 Medical Center of the Rockies 2500 Rocky Mountain Avenue Loveland CO 80538 970-624-1705 Memorial Health Sysytem 1400 E. Boulder Street Colorado Springs CO 80909-5599 719-365-5313 719-365-5730 Medical City Dallas Hospital 7777 Forest Lane Dallas TX 75230 972-566-5573 972-566-8046 Medical University of South Carolina 326 Calhoun Street Suite 239 Charleston SC 29401 843-792-6401 843-792-0072 Memorial Health System 1400 E. Boulder Street Colorado Springs CO 80909-5599 719-365-5313 719-365-5730 Memorial Health University Medical Center Cardiac Cath Lab Memorial Health University Medical Center 4700 Waters Avenue Savannah GA 31404 912-350-7233 912-350-7692 Memorial Hermann Hospital 6411 Fannin Street Houston TX 77030 713-704-0173 Memorial Hermann HVI South West 7787 Southwest Freeway Houston TX 77074 713-778-2227 713-778-2290 Memorial Hermann Memorial City Hospital 921 Gessner Road Houston TX 77024 713-242-3968 713-242-3539 Memorial Hermann Northeast 18951 Memorial North Humble TX 77338 281-540-7974 281-540-6411 Memorial Hermann Northwest Hospital 1635 North Loop West Houston TX 77008 713-867-4587 Memorial Hermann The Woodlands Hospital 9250 Pinecroft Drive Spring TX 77380 281-364-4185 281-364-4186 Memorial Hospital 2525 Desales Avenue Chattanooga TN 37404-1102 423-495-6245 423-495-4122 Memorial Hospital at Gulfport 4500 13th Street PO Box 1810 Gulfport MS 39502 228-575-2482 228-575-2469 Memorial Hospital Carbondale 405 W. Jackson Street Carbondale IL 65902 618-549-0721 x65472 618-529-0437 Memorial Hospital Miramar 1901 SW 172 Avenue Miramar FL 33029 954-538-4650 Memorial Hospital of Martinsville 320 Hospital Drive Martinsville VA 24112 276-666-7799 Memorial Hospital of Rhode Island Brown University 111 Brewster Street Pawtucket RI 02860 401-729-2642 Memorial Hospital of South Bend 615 N. Michigan Street South Bend IN 46601-1033 574-647-3593 574-647-6691 Memorial Hospital of Tampa 2901 W. Swann Avenue Tampa FL 33609 813-0873-6400 x5305 813-342-1515 Memorial Hospital Pembroke/ South Broward Hospital 7800 Sheridan Street Pembroke Pines FL 33024 954-963-8000 Memorial Hospital West/South Broward Hospital District 703 North Flamingo Road Pembroke Pines FL 33028 954-430-6880 x7510 Memorial Hospital—Jacksonville 3625 University Boulevard South Jacksonville FL 32215 904-399-6019 904-399-6381 Memorial Hospitals Association 1700 Coffee Road Modesto CA 95355 209-526-4500 ext. 6084 209-572-7017 Memorial Medical Center 701 N. First Street Springfield IL 62781 217-757-4263 217-788-5526 Memorial Medical Center 2450 S. Telshor Boulevard Las Cruces NM 88011 505-556-5861 505-521-5076 Memorial Medical Center 1086 Franklin Street Johnstown PA 15905-4398 814-534-3459 814-534-3467 Memorial Regional Hospital/South Broward Hospital 3501 Johnson Street Hollywood FL 33021 954-987-2020 x1025 954-986-6949 Memphis Hospital (Germantown Campus) 1265 Union Avenue Memphis TN 38104-3499 901-516-9087 Memphis Hospital (North Campus) 1265 Union Avenue Memphis TN 38104-3499 901-516-9087 901-516-2682 Memphis Hospital (University Campus) 1265 Union Avenue Memphis TN 38104-3499 901-516-9087 Menifee Valley Medical Center 28400 McCell Boulevard Sun City CA 92585 951-672-7042 951-672-7055 Menorah Medical Center 5721 West 119th Street Overland Park KS 66209 913-498-6033 913-498-6106 Mercy Fitzgerald Hospital 1500 Lansdowne Avenue Darby PA 19023 610-237-4328 610-237-4264 Mercy General Health Partners 1500 E. Sherman Boulevard Muskegon MI 49444 231-672-4606 231-672-3965 Mercy General Hospital—Sacramento 3939 J Street Suite 215 Sacramento CA 95819 916-453-4231 916-453-4587 Mercy Gilbert Medical Center 3555 South Val Vista Drive Attn.: Cardiac Cath Lab Gilbert AZ 85296 480-728-7050 480-728-9645 Mercy Health System of Northwestern Arkansas 1200 West Walnut Street Rogers AR 72756 479-986-3422 479-619-3237 Mercy Hospital 2925 Chicago Avenue Minneapolis MN 55407 763-458-3245 763-322-8738 Mercy Hospital—Scranton 746 Jefferson Avenue Scranton PA 18501 570-348-7885 570-348-2147 Mercy Hospital & Medical Center 2525 South Michigan Avenue Chicago IL 60616 312-567-7938 312-567-6587 Mercy Hospital Attn.: Accounts Payable 3663 South Miami Avenue Miami FL 33133 305-860-5271 305-860-5163 Mercy Hospital of Buffalo 565 Abbott Road Buffalo NY 14220 716-828-2824 716-828-2714 Mercy Hospital Attn: A/P 271 Carew Street PO Box 9012 Springfield MA 01102 413-748-9621 413-748-9634 Mercy Iowa City 500 East Market Street Iowa City IA 52245 319-339-3678 Mercy Medical Center 2700 Steward Parkway Roseburg OR 97470 541-677-2471 541-677-4416 Mercy Medical Center 801 5th Street Sioux City IA 51101 712-279-2348 Mercy Medical Center 1111 6th Avenue Des Moines IA 51101 712-279-2348 Mercy Medical Center 1320 Mercy Drive Cardiology Management and Support 3C Canton OH 44708 330-489-1000 x1637 Mercy Medical Center 301 St. Paul Place Baltimore MD 21202 410-951-7947 Mercy Medical Center 500 S. Oakwood Road Oshkosh WI 54904 920-730-2621 Mercy Medical Center 701 10th Street SE Cedar Rapids IA 52403 319-533-0060 319-398-6336 Mercy Medical Center 1000 North Village Ave Rockville Centre NY 11571 516-705-2058 516-705-2774 Mercy Medical Center Merced 301 E. 13th Street Merced CA 95340 209-385-7814 209-385-7816 Mercy Medical Center Redding 2175 Rosaline Avenue; PO Box 496009 Redding CA 96049-6009 530-247-3474 530-242-5212 Mercy Medical Center—North Iowa 1000 4th Street SW Mason City IA 50401 641-422-5177 641-422-5179 Mercy Regional Health Center 1823 College Avenue Manhattah KS 67218 785-776-2889 Mercy Regional Medical Center 1010 Three Springs Boulevard Durango CO 81301 970-764-2285 970-764-2299 Mercy San Juan Hospital 3941 J Street c/o Mercy General Hospital Administration Sacramento CA 95819 916-453-4231 916-453-4587 MeritCare Hospital MeritCare Hospital/Heart Services Data/Research Fargo ND 58122 701-234-7242 701-234-7404 Meriter Hospital 202 South Park Street 10 Tower—Heart Center Madison WI 53715 608-417-5875 608-417-6198 Mesa General Hospital 515 N. Mesa Drive Mesa AZ 85201 480-827-2448 480-827-2495 Methodist Health System PO Box 655999 Dallas TX 75203 214-947-8181 Methodist Hospital 7700 Floyd Curl Drive San Antonio TX 78229 210-575-6808 Methodist Hospital 6500 Excelsior Boulevard 2nd Floor HVC St. Louis Park MN 55426 952-993-2362 952-993-6879 Methodist Hospital of South CA 300 W Huntington Drive Arcadia CA 91007-3402 626-898-8670 626-821-6982 Methodist Hospital Southlake Campus 8701 Broadway Merrillville IN 46410-7035 219-738-3555 219-738-3431 Methodist Medical Center 280 Fort Sanders Boulevard Building 4, Suite 218 Knoxville TN 37922 865-531-5361 865-531-5036 Methodist Medical Center of Illinois 221 NE Glen Oak Avenue Peoria IL 61636 309-672-4133 309-672-4116 Methodist Speciality and Transplant Hospital 7700 Floyd Curl Drive San Antonio TX 78229 Methodist Sugar Land Hospital 16655 Southwest Freeway Sugar Land TX 77479 281-274-8325 281-274-8335 Methodist Willowbrook Hospital 18220 Tomball Parkway Houston TX 77070 281-477-1044 Metro Health Hospital 5900 Byron Center Road Wyoming MI 49519 616-252-7415 616-252-0417 MetroHealth Medical Center 2500 MetroHealth Drive Cleveland OH 44109 216-778-4793 216-778-8662 Metroplex Hospital 2201 S. Clear Creek Road Killeen TN 76549 254-519-8447 MetroWest Medical Center 115 Lincoln Street Cardiac Cath Lab Framingham MA 01702-6327 508-383-1338 508-383-1458 Miami Valley Hospital One Wyoming Street Dayton OH 45409 937-208-6638 937-208-6685 Middletown Regional Hospital One Medical Center Franklin OH 45005 513-420-5755 x6452 513-420-5002 Midland Memorial Hospital 2200 W. Illinois Avenue c/o Heart Institute Midland TX 79701 432-685-6966 Midlands Community Hospital 6901 N. 72nd Street Omaha NE 68122 402-572-2689 402-572-2371 MidMichigan Medical Center—Midland 4005 Orchard Drive Midland MI 48670 989-837-9044 989-837-9032 Midwest Regional Medical Center 2825 Parklawn Drive Midwest City OK 73110 405-610-8069 Milford Regional Medical Center 14 Prospect Street Milford MA 01568 508-422-2463 508-487-9328 Millard Fillmore Hospital 100 High Street Buffalo NY 14203 716-859-1080 716-859-3765 Mills-Peninsula Hospital 1783 Elcamino Real Burlingame CA 94010 650-696-5937 650-696-5460 Mission Hospital Regional Medical Center 27700 Medical Center Road Mission Viejo CA 92691-6426 949-364-1400 x2048 949-365-2320 Mission Hospitals, Inc. 509 Biltmore Avenue Asheville NC 28801-4690 828-213-7037 828-213-7296 Mission Regional Medical Center 900 S. Bryan Road Mission TX 78572 956-323-1904 Mississippi Baptist Medical Center 1225 N State Street Jackson MS 39202-2097 601-968-1011 601-968-1142 Missouri Baptist Medical Center 3015 N. Ballas Road 3105 North Ballas Road Saint Louis MO 63131-2374 314-996-5693 314-432-2245 Moberly Regional Medical Center 1515 Union Avenue Moberly MO 65270 660-269-2949 660-269-2948 Mobile Infirmary Medical Center PO Box 2144 Mobile AL 36652 251-435-2540 251-435-7278 Monongalia Genera; Hospital 1200 JD Anderson Drive Morgantown WV 26505 304-285-5173 304-285-5109 Montefiore Medical Center 111 East 210th Street Bronx NY 10467-2490 718-920-7389 718-920-6798 Montgomery General Hospital 18101 Prince Philip Drive Olney MD 20832 301-774-8952 301-570-7866 Morris Hospital 150 West High Street Morris IL 60450 815-942-2932 815-942-9538 Morristown Memorial Hospital 100 Madison Avenue Morristown NJ 07962 973-971-8848 973-290-7337 Morton Plant Hospital 207 Jeffords Street Clearwater FL 33756 727-461-8274 727-461-8651 Morton Plant North Bay Hospital 6600 Madison Street New Port Richey FL 34652 727-461-8274 Moses Cone Health System 1200 N. Elm Street Greensboro NC 27401 336-832-2851 336-832-2851 Mother Frances Hospital 800 E.Dawson Street Tyler TX 75701 903-531-4309 903-525-1589 Mount Auburn Hospital 330 Mount Auburn Street South 2—Administration Cambridge MA 02138 617-441-1625 617-499-5132 Mount Carmel East 6150 East Broad Street Office EB 148 Columbus OH 42313 614-546-4786 614-546-4798 Mount Carmel St. Ann's Hospital 6150 East Broad Street Office EB 148 Columbus OH 42313 614-546-4786 614-546-4798 Mount Carmel West 6150 East Broad Street Office EB 148 Columbus OH 42313 614-546-4786 614-546-4798 Mount Clemens Regional Medical Center 1000 Harrington Street Mount Clemens MI 48043-2992 586-493-8088 586-493-8835 Mount Sinai Medical Center 4300 Alton Road Miami Beach FL 33140 305-535-7950 305-674-2556 Mountainview Hospital 3100 N. Tenaya Way Las Vegas NV 89128 702-255-5102 702-255-5029 Munroe Regional Medical Center 1500 SW 1st Avenue PO Box 6000 Ocala FL 34478 352.351.7200 ext 6478 352.671.2034 Munson Medical Center 1105 Sixth Street Traverse City MI 49684-2386 231-935-7633 231-315-6524 Muskogee Regional Medical Center 300 Rockefeller Drive Muskogee OK 74401 918-684-2357 918-781-6308 Nacogdoches Medical Center 4920 NE Stallings Drive Nacogdoches TX 75965 936-568-3407 Naples Community Hospital 350 7th Street South Naples FL 34102 239-436-5226 Natchez Regional Medical Center 54 Sgt. Prentiss Drive Natchez MS 39120 601-443-2691 NEA Baptist Memorial Hospital 3024 Stadium Boulevard Jonesboro AR 72401 870-972-7079 Nebraska Heart Hospital 7500 South 91st Street Lincoln NE 68526 402-328-3047 402-328-3035 Nebraska Methodist Hospital 8303 Dodge Street Omaha NE 68114 402-354-4733 402-354-8790 New Hanover Regional Medical Center 2131 S. 17th Street Wilmington NC 28402 910-342-3285 910-342-3820 New Milford Hospital 21 Elm Street New Milford CT 06776 860-210-5065 860-350-7714 New York Community Hospital 2525 Kings Highway Brooklyn NY 11229 718-692-8745 718-692-8456 New York Hospital Medical Center of Queens Health Education Library 56-45 Main Street EO Lab 3rd Floor Flushing NY 11355 718-661-7400 New York Methodist Hospital 506 6th Street Brooklyn New York City NY 11215 718-780-3464 718-780-7763 New York Presbyterian Hospital 6220West 168th Street PH-2 New York City NY 10032 212-305-1788 212-305-1708 Newark Beth Israel Medical Center 201 Lyons Avenue at Osborne Terrace Newark NJ 07112 973 926 7283 973 926 6526 Nicholas H. Noyes Memorial Hospital 111 Clara Barton Street Dansville NY 14437 585-335-4349 585-335-5881 NIX Healthcare System 414 Navarro Street San Antonio TX 78205 210-579-3221 Norman Regional Health System PO Box 1308 Norman OK 73070-1308 405-307-1064 405-307-1168 North Austin Medical Center 12221 MoPac Expressway North Austin TX 78758 512-901-1327 512-901-1969 North Bay Medical Center 1200 B. Gale Wilson Boulevard Fairfield CA 94533 707-429-6706 707-429-6862 North Carolina Baptist Hospital Medical Center Boulevard Winston-Salem NC 27157 336-716-5861 North Central Baptist Hospital 520 Madison Oak Drive San Antonio TX 78258 210-297-1264 210-297-0926 North Colorado Medical Center 1801 16th Street Greeley CO 80631 970-350-6167 970-350-6164 North Cypress Medical Center 21214 Northwest Freeway Cypress TX 77429 832-912-3500 North Florida Regional Medical Center 6500 Newberry Road Gainesville FL 32605 352-333-4925 352-333-4295 North Hills Hospital 4401 Booth Calloway Road North Richland Hills TX 76180 817-255-1894 817-255-1888 North Kansas City Hospital 2800 Clay Edward Drive North Kansas City MO 64116 816-691-5036 816-346-7672 North Memorial Medical Center 3300 Oakdale Avenue, N Robbinsdale MN 55422 763-520-5478 North Mississippi Medical Center 830 S. Gloster Street Tupelo MS 38801 662-377-4667 662-377-2733 North Oaks Medical Center 15790 Paul Vega MD Drive Hammond LA 70403 985-230-6836 985-230-6438 North Ridge Medical Center 5757 N. Dixie Highway Fort Lauderdale FL 33334 954-776-6000 x2137 954-202-4876 North Shore Medical Center—Salem Hospital 81 Highland Avenue Davenport 5 Salem MA 01970 978-354-2506 978-825-6493 North Shore University Hospital 300 Community Drive Manhasset NY 11030 516-562-1463 516-562-3675 North Suburban Medical Center 9191 Grant Street Denver CO 80229 303-450-4447 303-450-4594 North Vista Hospital 1409 E. Lake Mead Boulevard North Las vegas NV 89030 702-657-5504 Northeast Alabama Regional Medical Center PO Box 2208 400 East 10th Street Anniston AL 36202 256-235-5499 256-231-8362 Northeast Baptist Hospital 8811Village Drive San Antonio TX 78217 210-297-1264 210-297-0926 Northeast Georgia Medical Center 743 Spring Street Gainesville GA 30501 678-989-2818 770-538-7592 NorthEast Medical Center 920 Church Street North Concord NC 28025 704-783-4156 704-783-1436 Northeast Methodist Hospital 12412 Judson Road Live Oak TX 78233 210-757-5868 210-757-5859 Northern Illinois Medical Center 4201 Medical Center Drive McHenry IL 60050 815-759-4581 815-759-4568 Northern Michigan Regional Hospital 416 Connable Avenue Petoskey MI 49770 231-487-7581 231-487-7720 Northridge Hospital Medical Center 18300 Roscoe Avenue Northridge CA 91325 818-885-8500 ext. 2283 818-885-5333 Northshore Regional Medical Center 100 Medical Center Drive Slidell LA 70461 985-646-5746 985-646-5007 Northside Hospital 1000 Johnson Ferry Road Atlanta GA 30342 404-851-8963 Northside Hospital 6000 49th Street, N Pinellas Park FL 33709 727-521-5068 727-521-5044 Northside Hospital—Forsyth 1200 Northside Forsyth Drive Cumming GA 30041 770-844-3607 770-844-3503 Northwest Community Hospital 800 W. Central Road Arlington Heights IL 60005 847-618-7627 Northwest Hospital 1550 North 115th Street Seattle WA 98113 206-368-5760 Northwest Hospital center 5401 Old Court Road Randallstown MD 21133 410-496-7126 410-521-2843 Northwest Medical Center 2801 N. State Road 7 Margate FL 33063 954-978-4059 Northwest Medical Center Northwest Medical Center 6200 N. La Cholla Boulevard Tucson AZ 85741 520-469-8489 520-469-8949 Northwest Medical Center—Bentonville 3000 Medical Center Parkway Bentonville AR 72712 479-553-4508 Northwest Medical Center—Springdale 609 West Maple Street Springdale AR 72764 479-757-4244 Northwest Mississippi Regional Medical Center 1970 Hospital Drive Clarksdale MS 38614 662-624-3283 662-621-5077 Northwestern Memorial Hospital 676 N. St. Clair Street, Suite 1700 Chicago IL 60611 312-926-1096 312-695-6854 Norton Audubon PO Box 35070 Louisville KY 40232 502-629-8893 502-629-4044 Norton Hospital PO Box 35070 Louisville KY 40232 502-629-8893 502-629-4044 Norwalk Hospital 24 Stevens Street Norwalk CT 06856 203-852-2127 NYU Medical Center 560 First Avenue New York NY 10016 212-263-7514 Oak Hill Hospital 11375 Cortez Boulevard Brooksville FL 34613 352-597-7085 Oakwood Hospital & Medical Center 18101 Oakwood Boulevard Suite 124 Dearborn MI 48124 313-593-8581 313-436-2082 Obici Hospital 2800 Godwin Boulevard Suffolk VA 23434 757-934-4500 Ocala Regional Mecical Center 1431 SW First Avenue Ocala FL 34474 352-401-1484 352-401-1552 Ocean Springs Hospital 3109 Bienville Boulevard Ocean Springs MS 39564 228-818-1111 Ochsner Medical Center—Baton Rouge 17000 Medical Center Drive Baton Rouge LA 70816 225-755-4934 225-755-4870 Ochsner Medical Center—West Bank 2500 Belle Chasse Highway Gretna LA 70056 504-391-5560 504-391-5530 Ochsner Medical Center—Kenner (Kenner Regional Medical Center) 180 West Esplanade Avenue Kenner LA 70065 504-464-8116 504-464-8733 Ochsner Medical Foundation 1514 Jefferson Highway New Orleans LA 70121 504-842-3726 504-838-8853 Oconee Regional Medical Center 812 N. Cobb Street Milledgeville GA 31061 478-454-3663 O'Connor Hospital 2105 Forest Avenue San Jose CA 95128 408-918-6224 Odessa Regional Hospital 520 East Sixth Street Odessa TX 79760 432-582-8147 432-582-8927 Ogden Regional Medical Center 5475 South 500 East Ogden UT 84403 801-479-2473 801-479-2037 Ohio State University Medical Center >410 W. 10th Avenue 142 Doan Hall Columbus OH 43210-1228 614-293-6332 614-293-8862 Ohio Valley Medical Center 2000 Eoff Street Wheeling WV 26003 304-234-8146 304-234-1815 Oklahoma Heart Hospital 4050 W. Memorial Road Oklahoma City OK 73120 405-608-3511 405-608-1498 Oklahoma State University Medical Center 744 W. 9th Street Tulsa OK 74127 918-599-5239 918-599-5444 Olathe Medical Center 20333 W. 151st Street Olathe KS 66061-7211 913-791-4265 913-791-3508 Opelousas General Health System 539 E. Prudhomme Street Opelousas LA 70570 337-594-3912 337-407-1403 Orange Coast Memorial Medical Center 9920 Talbert Avenue Fountain Valley CA 92708 714-378-7505 714-378-7161 Orange Regional Medical Center 60 Prospect Avenue Middletown NY 10940 845-343-2424 ext. 4503 Oregon Health & Science University 3181 SW Sam Jackson Road Portland OR 97239 503-494-3405 503-494-0822 Orlando Regional Medical Center 1414 Kuhl Avenue Orlando FL 32806 321-841-8047 407-872-1275 Osceola Regional Medical Center 700 W. Oak Street Kissimmee FL 34745 407-518-3994 OSF Saint Anthony Medical Center 5666 East State Street Rockford IL 61108 815-227-2160 OSF Saint Joseph Medical Center 2200 E. Washington Street Bloomington IL 61701 309-661-5070 OSF Saint Francis Medical Center 530 N.E. Glen Oak Avenue Peoria IL 61637 309-655-6839 309-655-7861 OU MEDICAL CENTER 700 NE 13th Street Oklahoma City OK 73104 405-271-4811 Our Lady of Lourdes Medical Center 1600 Haddon Avenue Camden NJ 08103 856-365-4082 Our Lady of Lourdes Regional Medical Center 611 Saint Landry Street PO Box 4027 Lafayette LA 70506 337-289-4650 Our Lady of The Lake Regional 5000 Hennessy Boulevard Baton Rouge LA 70808-4350 225-765-8691 225-765-6638 Our Lady of the Resurrection Medical Center 5645 W. Addison Street Chicago IL 60634 773-794-7638 773-794-8428 Overlake Hospital Medical Center 1035 116th Avenue NE Bellevue WA 98004 425-688-3722 425-283-5119 Overland Park Regional Medical Center/Health Midwest 10500 Quivira Road Overland Park KS 66215 913-541-5996 Owensboro Medical Health System 811 E. Parrish Avenue Owensboro KY 42303 270-688-1594 270-688-2683 Ozarks Medical Center 100 Kentucky Avenue West Plains MO 65775 417-256-1718 417-256-1785 P and S Surgical Hospital 312 Grammont Street Monroe LA 71201 318-998-8212 318-998-8220 Palm Beach Gardens Medical Center 3360 Burns Road Palm Beach Gardens FL 33410 561-694-7185 Palmetto General Hospital 2001 West 68th Street Hialeah FL 33016 305-819-1208 305-819-1203 Palmetto Health Heart Hospital 6 Richland Medical Park Drive Suite 4525 Columbia SC 29203 803-434-2049 803-434-2058 Palomar Medical Center 555 East Valley Parkway Escondido CA 92025 760-739-3551 Palos Community Hospital 12251 S. 80th Avenue Cardiovascular Services Palos Heights IL 60463-0930 708-923-5443 708-923-4448 Paoli Hospital 557 Lankenau MOB East 100 Lancaster Avenue Wynnewood PA 19096 610-526-8661 Paradise Valley Hospital 3929 E. Bell Road Phoenix AZ 85032 602-923-5777 602-923-5750 Paradise Valley Hospital 2400 E. Fourth Street National City CA 91950 619-470-4263 619-470-4162 Paris Regional Medical Center 820 Clarksville Street Paris TX 75460 903-737-3874 903-737-3649 Park Plaza Hospital 1313 Hermann Drive Houston TX 77004 713-527-5112 Parkland Health and Hospital Systems 5201Harry Hines Boulevard Dallas TX 75235 214-590-8966 Parkridge Medical Center 2333 McCallie Avenue Chattanooga TN 37404 423-493-1798 423-493-7962 Parkview Hospital 2200 Randallia Drive Fort Wayne IN 46805 260-373-4640 260-373-7295 Parkview Hospital 1726 Shawano Avnue Green Bay WI 54303-3282 920-498-4235 Parkview Medical Center 400 W. 16th Street Pueblo CO 81003 719-584-4650 719-584-4209 Parkwest Medical Center 9352 Parkwest Boulevard Knoxville TN 37923 865-373-1328 865-373-1322 Parma Community General Hospital 7007 Powers Boulevard Parma OH 44129 440-743-2317 440-743-4058 Parrish Medical Center 951 N. Washington Avenue Titusville FL 32796 321-268-6874 321-268-6369 Pasco Regional Medical Center 13000 100 Fort King Road Dade City FL 33525 352-518-1020 Peace River Regional Medical 2500 Harbor Boulevard Port Charlotte FL 33952 941-766-4142 941-766-4169 Peconic Bay Medical Center 1300 Roanoake Avenue Riverhead NY 11901 631-548-6871 Peninsula Regional Medical Center 100 East Carroll Street Salisbury MD 21801 410-543-7530 x3444 410-543-7134 Penn Presbyterian Medical Center 39th & Market Streets Philadelphia PA 19104 215-662-9142 215-243-3254 Penn State Hershey Medical Center PO Box 850 H139 Hershey PA 17033 717-531-6416 717-531-0174 Pennsylvania Hospital 800 Spruce Street Philadelphia PA 19107-6192 215-829-5335 Penrose—St. Francis Health Services 2222 North Nevada, #220 Colorado Springs CO 80907 1-719-776-2992 1-719-776-5823 Phelps County Regional Medical Center 1000 W. 10th Street Rolla MO 65401 573-458-7689 Phoenix Baptist Hospital 2000 W. Bethany Home Road Phoenix AZ 85015 602-246-5511 602-246-5929 Phoenixville Hospital 140 Nutt Road Phoenixville PA 19460-3906 610-983-1236 610-983-1238 Physicians Medical Center Carraway 1600 Carraway Boulevard Birmingham AL 35234 205-502-6936 205-502-5563 Piedmont Hospital 95 Collier Road Suite 2075 Atlanta GA 30309 404-605-3122 404-605-0276 Piedmont Medical Center 222 S. Herlong Avenue Rock Hill SC 29732 803-981-7499 Pikesville Medical Center 911 Bypass Road Pikesville KY 41501 606-218-4961 606-437-3979 Pinnicle Health Invasive Cardiology 111 South Front Street Harrisburg PA 17101-2099 717-782-3170 717-782-5807 Pioneer Valley Hospital 3590 West 9000 South, Suite 315 West Jordan UT 84088 Pitt County Memorial Hospital 300 Moye Boulevard Greenville NC 27834 252-744-5316 252-744-1317 Plantation General Hospital 401 NW 42nd Avenue Plantation FL 33317 954-513-6459 Plaza Medical Center of Fort Worth 900 Eighth Avenue Fort Worth TX 76104 817-347-4957 817-347-5711 Pocono Medical Center 206 East Brown Street East Stroudsburg PA 18301 570-420-5878 570-422-8394 Pomona Valley Hospital Med Center 1798 N. Garey Avenue Pomona CA 91768 909-865-9501 x4331 909-623-6354 Pontiac Osteopathic Hospital 50 N. Perry Street Pontiac MI 48342 248-338-5229 248-338-5569 Poplar Bluff Regional Medical Center 2620 N. Westwood Boulevard Poplar Bluff MO 63901 573-727-2544 573-727-2549 Port Huron Hospital 1221 Pine Grove Avenue Port Huron MI 48060 810-985-2631 810-985-2696 Porter Adventist Hospital 2525 S. Downing Street Denver CO 80210-5817 303-765-3593 303-765-3734 Porter Valparaiso Hospital Campus 814 Laporte Avenue Valparaiso IN 46383 219-263-7277 219-263-7942 Portneuf Medical Center 651 Memorial Drive Pocatello ID 83201 208-239-2554 208-239-3741 Portsmouth Regional Hospital 333 Borthwick Avenue Portsmouth NH 03801 603-433-5266 603-433-4047 Prairie Lakes Healthcare 401 9th Avenue Watertown SD 57201 605-882-7672 605-882-7720 Presbyterian Healthcare Services PO Box 26666 Albuquerque NM 87125 505-841-1145 505-841-1382 Presbyterian Hospital 200 Hawthorne Lane Charlotte NC 28233 704-384-9838 704-316-9104 Presbyterian Hospital—Denton 3000 I-35 N Denton TX 76201 940-898-7225 Presbyterian Hospital—Dallas Presbyterian Hospital 8200 Walnut Hill Lane Dallas TX 75231 214-345-6022 214-345-6081 Presbyterian Hospital—Plano 6200 West Parker Road Plano TX 75093-7914 972-981-3362 972-981-3022 Presbyterian Intercommunity Hospital 12401 Washington Boulevard Whittier CA 90602 562-698-0811 ext. 2637 562-698-1351 Presbyterian/St.Luke's Medical Center 1719 E. 19th Avenue Denver CO 80218-1235 303-839-6164 303-839-6786 Prince George's Hospital Center 3001 Hospital Drive Cheverly MD 20785 240-988-2272 301-618-6460 Princeton Baptist Medical Center Princeton BMC, Nursing Administration 701 Princeton Avenue, SW Birmingham AL 35211-1399 205-783-3327 205-783-7172 Proctor Hospital 5409 N. Knoxville Avenue Peoria IL 61614 309-689-8641 309-689-8629 Protestant Memorial Medical Center 4500 Memorial Drive Belleville IL 62226 618-257-5046 618-257-6811 Provena Covenant Medical Center 1400 West Park Street Urbana IL 61801-9901 217-443-5000 x4614 Provena Mercy Medical Center 1325 North Highland Avenue Aurora IL 60506 630-801-2796 630-801-5545 Provena Saint Joseph Medical Center 333 North Madison Street Joliet IL 60435-6595 815-725-7133 815-773-7072 Provena Saint Marys Hospital 500 West Court Street Kankakee IL 60901 815-937-2137 815-935-6662 Provena St. Joseph Hospital 77 N. Airlite Street Elgin IL 60123 847-695-3200 x5321 847-888-3514 Providence Alaska Medical Center 3200 Providence Drive Anchorage AK 99508-4662 907-261-4934 907-261-3683 Providence Everett Medical Center 1321 Coby Avenue PO Box 1147 Everett WA 98206-1147 425-261-3904 425-261-3901 Providence Health Center 6901 Medical Parkway Waco TX 76712 254-751-4732 254-751-4584 Providence Holy Cross Medical Center 501 South Buena Vista Street Burbank CA 91505 818-847-3897 Providence Hospital 6801 Airport Boulevard Mobile AL 36608 251-631-3455 251-639-2911 Providence Hospital 2435 Forest Drive Columbia SC 29204 803-227-7039 803-400-5039 Providence Medford Medical 1111 Crater Lake Avenue Medford OR 97504 541-732-6698 541-732-6698 Providence Medical Center 8929 Parallel Parkway Kansas City KS 66112-1689 913-596-4614 913-596-4996 Providence Memorial Hospital 2001 North Oregon Street El Paso TX 79902 915-747-2873 915-747-2873 Providence Portland Medical Center 9205 SW Barnes Road 9205 South West. Barnes Road Portland OR 97225 503-216-7184 503-216-7274 Providence Saint Joseph Medical Center 501 South Buena Vista Street Burbank CA 91505 818-847-3897 Providence Saint Vincent Medical Center Regional Heart Data Services 9205 South West Barnes Road #33 Portland OR 97225 503-216-7184 503-216-7274 Providence St. Peter Hospital 413 N. Lilly Road Olympia WA 98506 360-493-4508 360-493-5213 Queen of the Valley Medical Center 1000 Trancas Street Napa CA 94558 707-251-1390 707-251-1722 Queens Medical Center 1301 Punchbowl Street Honolulu HI 96813 808-389-7744 808-547-4077 Rancho Spring Medical Center 36485 Inland Valley Drive Wildomar CA 92595 Rankin Medical Center 350 Crossgates Boulevard Brandon MS 39042 601-824-8374 601-824-8378 Rapid City Regional Hospital 353 Fairmont Boulevard Rapid City SD 57702 605-719-1220 605-719-4354 Rapides Regional Medical Center 211 4th Street Box 30101 Alexandria LA 71301 318-449-7540 318-449-7524 Redmond Regional Medical Center 501 Redmond Road Rome GA 30165 706-802-3831 1-866-947-1325 Regents of the University of Michigan 300 N. Ingalls Street 7A10 Ann Arbor MI 48109 734-998-8208 734-998-8203 Regional Hospital of Jackson 367 Hospital Boulevard Jackson TN 38305 731-661-2124 731-661-2216 Regional Medical Center 225 N. Jackson Avenue San Jose CA 95116 408-259-5000 ext. 2181 408-347-4072 Regional Medical Center 3000 St. Matthews Road Orangeburg SC 29118 803-395-2960 803-395-2925 Regional Medical Center 900 Hospital Drive Madisonville KY 42431-1644 270-825-5183 270-326-5021 Regional Medical Center Bayonet Point 14000 Fivay Road Hudson FL 34667 727-819-2929 x1235 Regions Hospital 640 Jackson Street Mail Stop 11102-M St. Paul MN 55101 651-254-3351 651-254-2390 Reid Hospital & Healthcare Services 1401 Chester Boulevard Richmond IN 47374 765-983-3476 765-983-3116 Renown Regional Medical Center 1155 Mill Street R 11 Reno NV 89502 775-982-5833 775-982-5602 Research Medical Center 2316 East Meyer Boulevard Cardiology Services Kansas City MO 64132 816-276-4421 816-276-4356 Reston Hospital Center 1850 Town Center Parkway Reston VA 20190 703-689-9071 Resurrection Medical Center 7435 Talcott Avenue Chicago IL 60631 773-792-8961 773-792-5179 Rex Hospital 4420 Lake Boone Trail Raleigh NC 27607 919-784-3192 919-784-3490 Rhode Island Hospital 593 Eddy Street Providence RI 02903 401-444-7193 401-444-7061 Richmond University Medical Center 355 Bard Avenue Staten Island NY 10310 718-818-4352 718-818-4247 Riddle Memorial Hospital 1068 W. Baltimore Pike Media PA 19063-5177 610-891-6205 610-891-6255 Rideout Memorial Hospital 726 4th Street Maryville CA 95901 530-751-4270 x1455 530-749-4593 Ridgecrest Regional Hospital 1081 N. China Lake Boulevard Ridgecrest CA 93555 760-499-3926 Riley Hospital 1102 Constitution Avenue Meridian MS 39301 601-484-3577 Rio Grande Regional Hospital 101 E. Ridge Road McAllen TX 78503 956-632-6731 956-632-6734 River Oaks Hospital 1030 River Oaks Drive Flowood MS 39232 601-936-2387 601-936-2249 River Region Medical Center 2100 Highway 61 North Vicksburg MS 39183 601-883-5759 601-883-6828 Riverside Community Hospital 4445 Magnolia Avenue Riverside CA 92501 951-788-3449 Riverside Medical Center 350 N. Wall Street Kankakee IL 60901 815-936-8966 815-802-1351 Riverside Methodist Hospital 3535 Olentangy River Road Columbus OH 43214 614-566-3757 614-566-6838 Riverside Regional Medical Center 500 J Clyde Morris Boulevard Newport News VA 23601 757-594-3309 757-594-3547 Riverview Hospital 395 Westfield Road Noblesville IN 46060 317-776-7177 Riverview Regional Medical Center 600 South Third Street PO Box 268 Gadsden AL 35901 256-543-5808 256-543-5535 Robert Packer Hospital 1 Guthrie Square Gadsden AL 18840 570-882-4916 570-882-5809 Robinson Memorial Hospital 6847 N. Chestnut Street Ravenna OH 44266 330-297-8217 330-297-4086 Rochester General Hospital 1425 Portland Avenue Rochester NY 14621 585-922-4693 Rockford Memorial Hospital 2400 North Rockton Avenue Rockford IL 61103 815-971-6727 815-971-9564 Rogue Valley Medical Cent 2825 E. Barnett Road Performance Improvement Dept. Medford OR 97504 541-789-4815 541-789-4811 Roper Hospital 316 Calhoun Street Charleston SC 29401 843-724-2683 843-724-1983 Rose Medical Center 4567 E. 9th Avenue Denver CO 80220-3941 303-320-2238 303-320-2645 Round Rock Medical Center 2400 Round Rock Medical Center Round Rock TX 78681 512-341-5227 Rush Hospital 1314 19th Avenue Meridian MS 39301 601-703-9494 Rush North Shore Medical Center 9600 Gross Point Road Skokie IL 60076 847-933-6787 847-933-3858 Rush Oak Park Hospital 520 South Maple Avenue Oak Park IL 60304-1097 708-660-6665 708-660-6658 Rush University Medical Center 1653 West Congress Parkway Chicago IL 60612 312-942-6806 312-942-7986 Rush-Copley Medical Center Attn: Health Science Library 2000 Ogden Avenue Alexander City AL 60504 630-898-5658 Russell Medical Center 3316 Highway 280 PO Box 939 Alexander City AL 35011 256-329-7180 Rutland Regional Medical Center 160 Allen Street Rutland VT 05701 802-772-2613 Sacred Heart Hospital of Pensacola 5151 North 9th Avenue Pensacola FL 32504-8721 850-416-7766 850-416-5245 Sacred Heart Hospital Attn: A/P 900 W. Clairemont Avenue Eau Claire WI 54701 715-839-4590 Sacred Heart Medical Center 1155 Hilyard Street Eugene OR 97401 541-984-4269 Sacred Heart Medical Center 101 W. Eighth Avenue Spokane WA 99204 509-474-3733 509-474-3741 Saddleback Memorial Medical Center 24451 Health Center Drive Laguna Hills CA 92653 949-452-3867 Saint Agnes Medical Center 1303 East Herndon Avenue Fresno CA 93720 559-450-3915 Saint Anthony Medical Center 1201 S. Main Street Crown Point IN 46307 219-757-6162 219-757-6367 Saint Bernadine Medical Center 2101 N. Waterman Avenue 2101 N. Waterman Avenue San Bernadino CA 92404-4836 909-881-7669 909-881-4534 Saint Clare's Hospital 611 St. Joseph's Avenue Marshfield WI 54449 715-389-5130 715-389-3200 Saint Elizabeth Health Center 1044 Belmont Avenue Youngstown OH 44511 330-480-6668 330-480-2572 Saint Elizabeth Hospital 2700 W. 9th Avenue Suite 107 Oshkosh WI 54904 920-223-1154 920-223-1180 Saint Elizabeth Medical Center—South 1 Medical Village Drive Edgewood KY 41017-3403 859-301-5672 859-301-3897 Saint Elizabeth Regional Medical Center 555 S. 70th Street Lincoln NE 68510-2462 402-219-7255 402-219-7900 Saint Elizabeth's Hospital 211 South 3rd Street Belleville IL 62220-1915 618-234-2120 x2105 618-222-4622 Saint Francis Hospital 2122 Manchester Expressway Columbus GA 31904 706-596-4166 706-596-4351 Saint Francis Hospital 5959 Park Avenue Memphis TN 38119 901-765-2358 Saint Francis Hospital 6161 S. Yale Avenue Tulsa OK 74136 918-494-6265 918-494-4199 Saint Francis Hospital & Health Center 8111 S. Emerson Avenue Indianapolis IN 46237 317-851-1545 317-851-1655 Saint Francis Hospital & Medical Center 114 Woodland Street Hartford CT 06105 860-714-4060 860-714-8001 Saint Francis Hospital and Health Center 12935 Gregory Street Blue Island IL 60406-2470 708-824-4893 708-824-4513 Saint Francis Hospital of Evanston 355 Ridge Avenue Evanston IL 60202 847-316-6245 847-316-4515 Saint John Hospital & Medical Center 22151 Moross Road Professional Bldg #1, #126 Detroit MI 48236-2148 313-343-7870 313-417-2758 Saint John Macomb—Oakland Hospital 11800 E. 12 Mile Road Room # 2510 Warren MI 48093 586-573-5891 586-573-5841 Saint Johns Mercy Medical Center 615 S. New Ballas Road St. Louis MO 63141 314-251-6544 314-251-4751 Saint Joseph Hospital 2900 N. Lake Shore Drive Chicago IL 60657-6274 773-665-3597 773-665-6348 Saint Joseph Hospital Saint Joseph Hospital & Medical Center 350 West Thomas Road Phoenix AZ 85013 602-406-6935 Saint Joseph Hospital 2700 Dolbeer Street Eureka CA 95501 707-445-8121 x6240 707-269-3842 Saint Joseph Hospital 3001 W. Martin Luther King Boulevard Tampa FL 33607 813-554-8711 813-870-4663 Saint Joseph Regional Health Center 2801 Franciscan Street Bryan TX 77802-2544 979-776-2941 979-776-4985 Saint Joseph's Hospital 1824 Murdoch Avenue Parkersburg WV 26102-0327 304-424-4577 304-424-4643 Saint Josephs Hospital/Marshfield Clinic 611 St. Joseph Avenue Marshfield WI 54449-1832 715-389-5130 715-389-3200 Saint Joseph's Hospital of Atlanta 5665 Peachtree Dunwoody Road Atlanta GA 30342 404-851-5059 Saint Louis University Hospital 3635 Vista at Grand Saint Louis MO 63110 314-577-8204 314-268-5472 Saint Luke's Hospital 1026 A Avenue, North East Cedar Rapids IA 52406-3026 319-369-8005 319-368-5583 Saint Luke's Hospital 4401 Wornall Road (MAHI 5th Floor) Kansas City MO 64111 816-932-5692 Saint Luke's Hospital 232 S. Woods Mill Road Chesterfield MO 63017-3417 314-205-6981 314-336-5472 Saint Luke's Regional Medical Center 190 E. Bannock Street Boise ID 83712-6241 208-381-1767 208-381-1631 Saint Margaret Mercy 5454 Hohman Avenue Hammond IN 46320 219.933.2120 219.933.2583 Saint Mary Corwin Medical Center 1008 Minnequa Avenue Pueblo CO 81004-3798 719-560-5280 719-560-5789 Saint Mary Mercy Hospital 36475 West Five Mile Road Livonia MI 48154 734-655-2988 734-655-2884 Saint Mary's Hospital 56 Franklin Street Waterbury CT 06706 203-709-6375 Saint Mary's Hospital and Regional Medical Center 2635 N. 7th Street Grand Junction CO 81501-8209 970-244-2312 970-244-7033 Saint Mary's Medical Center 2900 First Avenue Huntington WV 25702 304-526-8794 Saint Mary's Medical Center 3700 Washington Avenue Evansville IN 47750 812-485-4139 812-485-7030 Saint Mary's Regional Medical Center 235 W. Sixth Street Reno NV 89503 775-770-3929 775-770-3665 Saint Peter's Hospital 315 South Manning Boulevard Albany NY 12208 518-525-1983 Saint Rita's Medical Center 730 West Market Street Lima OH 45801-4602 419-996-5520 419-996-5409 Saint Rose Dominican—Siena Campus 3001 St. Rose Parkway Henderson NV 89052 702-616-5372 Saint Thomas Health Care Services 4220 Harding Road Nashville TN 37202-0380 615-222-6282 615-222-6285 Saint Vincent Health Center 252 West 25th Street Erie PA 16544 814-452-5467 814-452-5651 Saint Vincent Hospital 123 Summer Street Suite 270 Worcester MA 01608 508-363-7171 508-363-9621 Saint Vincent Hospital Manhattan 170 W. 12th Street New York NY 10011 212-604-7456 Saint Vincent Medical Center/Health Center 2 St. Vincent Circle Little Rock AR 72205 501-552-4826 Saint Vincent's Medical Center 2800 Main Street Bridgeport CT 06606 203-576-6114 203-576-6020 Salem Hospital (Regional Health Services) 665 Winter Street SE Salem OR 97301-3919 503-561-5412 Salina Regional Health Center 400 S. Santa Fe Avenue Salina KS 67401 785-452-6893 785-452-7044 Salinas Valley Memorial Hospital 450 E. Romie Lane Salinas CA 93901-4098 831-757-4333 ext. 2105 831-771-5079 Salt Lake Regional Medical Center 3580 W. 9000 W West Jordan UT 84088 801-562-3188 San Antonio Community Hospital 999 San Bernardino Road Upland CA 91786 909-920-6117 San Francisco Heart and Vascular Institute 1900 Sullivan Avenue Daly City CA 94015 650-991-6358 650-755-7315 San Jacinto Methodist Hospital 4401 Garth Road Baytown TX 77521 281-420-7372 San Joaquin Community Hospital 2615 Chester Avenue Bakersfield CA 93301 661-869-6508 661-869-6935 San Juan Regional Medical Center 801 W. Maple Street Farmington NM 87401 505-324-3373 505-599-4705 San Ramon Regional Medical Center 6001 Norris Canyon Road San Ramon CA 94583 625-570-7885 Sand Lake Hospital 1414 Kuhl Avenue Orlando FL 32806 321-841-8047 Sanford USD Medical Center 1305 West 18th Street Sioux Falls SD 57117 605-328-7873 605-333-1964 Santa Barbara Cottage Hospital PO Box 689 Santa Barbara CA 93102-0689 805-569-8282 805-569-7411 Santa Rosa Memorial Hospital 1165 Montgomery Drive PO Box 522 Santa Rosa CA 95402 704-525-5300 x5890 707-522-1555 Santa Theresa Community Hospital 250 Hospital Parkway 1st Floor Cath Office San Jose CA 95119 408-972-7492 408-972-7162 Sarasota Memorial Hospital 1700 S. Tamiami Trail Sarasota FL 34239 941-917-1331 941-917-6162 Satilla Heart Center 410 Darling Avenue Waycross GA 31501 912-287-2625 Savoy Medical Center 801 Poincianna Street Mamou LA 70554 337-468-5261 337-468-3342 Scott and White Hospital 2401 South 31st Street Temple TX 76508 254-724-5037 254-724-1799 Scottsdale Healthcare Osborn 7400 E. Osborn Road Scottsdale AZ 85260 480-882-5391 Scottsdale Healthcare Shea 9003 E. Shea Boulevard—Administration Scottsdale AZ 85260 480-882-5391 Scripps Green Hospital—La Jolla 10666 North Torrey Pines Road La Jolla CA 92037 858-554-3618 858-554-3636 Scripps Memorial Hospital—La Jolla 9888 Genessee Avenue La Jolla CA 92037 858-626-7057 858-626-4112 Scripps Mercy Hospital—San Diego 4077 5th Avenue MER 74 San Diego CA 92103 619-686-3462 619-260-7047 Scripps Mercy Hospital—Chula Vista 435 H Street Chula Vista CA 91910 619-691-7278 619-407-7666 Sebastian River Medical Center 13695 US Highway 1 Sebastian FL 32962 772-581-2019 772-388-3689 Self Regional Healthcare 1325 Spring Street Greenwood SC 29646 864-725-7004 Sentara Norfolk General Hospital 600 Gresham Drive Norfolk VA 23507 757-668-2035 757-668-3579 Sentara Obici Hospital 2800 Goodwin Boulevard Suffolk VA 23434 757-388-2035 757-388-3579 Sentara Virginia Beach General Hospital 1060 First Colonial Road Virginia Beach VA 23454-0685 757-395-6783 757-395-8725 Sequoia Hospital Whipple and Alameda Avenues 170 Alameda de Las Pulgas Redwood City CA 94062 650-367-5925 650-482-6187 Seton Medical Center 1201 W. 38th Street Austin TX 78705 512-324-1000 x17713 512-324-1083 Shady Grove Adventist Hospital 9901 Medical Center Drive Rockville MD 20850 301-279-6188 240-453-5915 Shands at AGH 801 SW 2nd Avenue Gainesville FL 32601 352-338-7177 352-338-7122 Shands Jacksonville Medical Center 655 West 8th Street Jacksonville FL 32209 904-244-3304 904-244-3102 Sharon Regional Health System 740 E. State Street Sharon PA 16146 724-983-3911 724-983-3965 Sharp Chula Vista Medical Center 8695 Spectrum Center Court San Diego CA 92123 619-482-5867 Sharp Grossmont 5555 Grossmont Center Drive La Mesa CA 91942 619-740-4123 619-740-4213 Sharp Memorial Hospital 7901 Frost Street San Diego CA 92123 858-939-6713 Shasta Regional Medical Center 1100 Butte Street Redding CA 96001 530-244-8200 Shawnee Mission Medical Center 9100 West 74th Street Shawnee Mission KS 66204-4004 913-676-2052 913-789-3190 Shelby Baptist Medical Center 1000 First Street North Alabaster AL 35007 205-620-8184 205-620-7003 Sherman Hospital 934 Center Street Decision Support Elgin IL 60120 847-429-1248 847-429-2816 Shore Health System of Maryland 219 South Washington Street Easton MD 21601 410-822-1000 x5810 Sierra Medical Center 1625 Medical Center Drive El Paso TX 79902 915-747-2873 915-747-2716 Sierra Vista Regional Medical Center 1010 S. Murray Avenue San Luis Obispo CA 93405 805-546-5122 805-546-5106 Silver Cross Hospital 1200 Maple Road Joliet IL 60432 815-740-7104 Simi Valley Hospital & Health Care Services 2975 North Sycamore Drive Simi Valley CA 93065 805-955-6000 Sinai—Grace Hospital 6071 W. Outer Drive Detroit MI 48235 313-966-6870 Sinai Hospital of Baltimore 2401 West Belvedere Avenue Baltimore MD 21215-5271 410-601-8140 Singing River Hospital 3109 Bienville Boulevard Ocean Springs MS 39564 228-818-5000 Skaggs Community Health Center PO Box 650 Branson MO 65615-0650 417-335-7442 417-335-7131 Sky Ridge Medical Center 10101 Ridgegate Parkway Lone Tree CO 80124 720-225-1865 720-225-1869 Skyline Medical Center/HTI Memorial Hospital Corp. 3441 Dickerson Pike Nashville TN 37207 615-769-4450 615-769-4451 Smith of Georgia, LLC d.b.a. Smith Northview Hopsital PO Box 10010 Valdosta GA 31604 229-671-2016 229-671-2054 Somerset Hospital 225 South Center Avenue Somerset PA 15501-2088 814-443-5390 814-443-5768 Sound Shore Medical Center 16 Guion Place New Rochelle NY 10801 914-365-4733 914-638-1393 South Bay Hospital 4016 Sun City Center Boulevard Sun City Center FL 33570 813-634-0280 South Crest Hospital 8801 S. 101st E Avenue Tulsa OK 74133 918-294-4677 918-294-4943 South Fulton Medical Center 1170 Cleveland Avenue East Point GA 30344 404-466-6404 404-466-6420 South GA Medical Center PO Box 1727 Valdosta GA 31603-1727 912-259-4340 912-259-4341 South Miami Hospital 6200 SW 73rd Street Miami FL 33143 786-662-5300 786-662-5138 South Nassau Communities Hospital One Healthy Way Oceanside NY 11572 516-632-3418 516-336-2943 South Shore Hospital 55 Fogg Road South Weymouth MA 02190-2432 781-340-8501 781-340-8826 Southeast Alabama Medical Center 1108 Ross Clark Circle Dothan AL 36301 334-793-8188 Southeast Baptist Hospital 4214 E. Southcross Boulevard San Antonio TX 78222 210-297-1264 210-297-0926 Southeast Missouri Hospital 1701 Lacey Street Cape Girardeau MO 63701 573-651-5557 573-986-5978 Southern Hills Hospital 9300 West Sunset Road Las Vegas NV 89148 702-880-2147 Southern New Hampshire Medical Center 8 Prospect Street Nashua NH 03060 603-577-2320 603-577-2909 Southern Ohio Medical Center 1805 27th Street Portsmouth OH 45662 740-356-8573 740-354-2798 Southern Regional Medical Center 11 Upper Riverdale Road SW Riverdale GA 30274 770-991-8682 770-991-8619 Southlake Hospital 1099 Citrus Tower Boulevard Clermont FL 34711 352-241-7276 352-241-7107 Southside Hospital 301 East Main Street Bayshore NY 11706 631-968-3009 631-968-3177 Southwest Florida Regional Medical Center 636 Del Prado Boulevard Suite 104 Cape Coral FL 33990 239-573-5548 239-573-5542 Southwest General Health Center 18697 Bagley Road Middleburg Heights OH 44130-3417 440-816-4760 440-816-5768 Southwest General Hospital 7400 Barlite Boulevard San Antonio TX 78224 210-921-3385 210-921-3438 Southwest Medical Center 2810 Ambassador Caffrey Parkway Lafayette LA 70506 337-981-2949 x1274 Southwest MS Regional Medical Center 303 Marion Avenue McComb MS 39648 601-249-1832 601-249-1835 Southwest Washington Medical Center 600 NE 92nd Avenue Vancouver WA 98664 360-514-3372 360-514-1852 Spalding Regional Medical Center 601 South 8th Street Griffin GA 30224 770-233-2013 Sparks Regional Medical Center P O Box 17006 1001 Towson Fort Smith AR 72917-7006 479-573-2330 479-441-4877 Sparrow Health System 1215 East Michigan Avenue Lansing MI 48909-7980 517-364-2506 517-484-9759 Spartanburg Regional Medical Center 101 East Wood Street Cardiac Cath Lab/3rd Floor Heart Center Spartanburg SC 29303 864-560-8345 864-560-6007 Spectrum Health 100 Michigan Street NE MC 037, Rm 3825A Grand Rapids MI 49503-2560 616-391-2458 616-391-2761 Spring Branch Medical Center 8850 Long Point Road Houston TX 77055 713-722-3214 713-722-3785 Spring Valley Hospital 5400 S. Rainbow Boulevard Las Vegas NV 89118 702-853-3162 702-853-8606 Springfield Regional Medical Center, Fountain Camp 1343 North Fountain Boulevard Springfield OH 45503 937-328-9319 937-328-8788 Springhill Memorial Hospital 3719 Dauphin Street Mobile AL 36608 251-460-5326 251-461-4126 Springs Memorial Hospital 800 West Meeting Street Lancaster SC 29720 803-286-1671 803-313-3152 SSM St. Joseph Health Center 300 First Capitol Drive St. Charles MO 63301 314-518-0751 636-947-5684 SSM St. Joseph Hospital of Kirkwood 525 Couch Avenue Kirkwood MO 63122 314-966-1578 314-256-6451 St. Anthony Central Hospital 4231 W. 16th Avenue Denver CO 80204-1335 303-629-2288 303-595-6912 St. James Hospital and Health Centers 20201 S. Crawford Avenue Olympia Fields IL 60461 708-679-2033 St. Joseph Hospital 700 Broadway Fort Wayne IN 46802 260-425-3425 St. Joseph Hospital—Oakland 44405 Woodward Avenue Pontiac MI 48341-5023 248-858-6038 248-858-3288 St. Joseph Medical Center 1717 South J Street Tacoma WA 98405-4933 253-426-6046 253-426-6440 St. Josephs Hospital 69 W. Exchange Street St Paul MN 55102 651-326-3088 651-232-3296 St. Joseph Hospital Health Center 301 Prospect Avenue Syracuse NY 13203 315-448-5832 315-448-5656 St. Luke's Cornwall Hospital 70 DuBois Street Newburgh NY 12550 845-568-2094 845-568-2980 St. Mary's Health Care Systems 1230 Baxter Street Athens GA 30606 706-389-2284 706-389-2285 St. Mary's Hospital 400 North Pleasant Centralia IL 62801 618-436-8980 618-436-8052 St. Mary's Regional Medical Center 305 S. 5th Street Enid OK 73701 580-249-3026 580-249-3994 St. Vincent Mercy Medical Center 2213 Cherry Street Toledo OH 43608 419-251-2761 St. Agnes Hospital 900 Caton Avenue Baltimore MD 21229 410-368-2822 410-368-3220 St. Alexius Medical Center 1555 Barrington Road Hoffman Estates IL 60194-1018 847-755-8678 847-755-8499 St. Alphonsus Regional Medical Center 1055 N. Curtis Road Boise ID 83706 208-367-2930 208-367-4270 St. Anthony Hospital 1000 N. Lee Avenue Oklahoma City OK 73102 405-272-7394 405-272-7169 St. Anthony's Health Care 1200 7th Avenue North MS 2019 St. Petersburg FL 33705 727-825-1520 727-825-1518 St. Anthony's Medical Center 10010 Kennerly Road St. Louis MO 63128-2106 314-525-1834 St. Barnabas Medical Center 94 Old Short Hills Road Livingston NJ 07039 973-322-5562 973-422-0723 St. Bernards Medical Center 225 E. Jackson Avenue Jonesboro AR 72401 870-972-4147 870-974-7021 St. Catherine Hospital East Chicago 1500 South Lake Park Avenue Hobart IN 46342 219-947-6767 219-947-6769 St. Catherine of Siena 50 Route 25A Smithtown NY 11787 631-862-3510 631-862-3802 St. Charles Medical Center 2500 North East Neff Road Bend OR 97701-6015 541-318-4985 541-383-6825 St. Clair Hospital St. Clair Hospital 1000 Bower Hill Road Pittsburgh PA 15243 412-942-2267 St. David's Medical Center 919 East 32nd Street Austin TX 78765 512-370-4420 St. David's South Austin Hospital 901 W. Ben White Boulevard Austin TX 78704 512-448-7373 512-448-7498 St. Dominic-Jackson Memorial Hospital 969 Lakeland Drive Jackson MS 39216 601-200-2713 St. Edwards Mercy Medical Center 7301 Rogers Avenue Ft. Smith AR 72917-7000 479-314-5682 479-314-1447 St. Elizabeth Hospital 2233 W. Division Street Chicago IL 60622 312-770-2244 312-770-2030 St. Elizabeth Hospital Medical Center 1501 Hartford Street Lafayette IN 47904 765-423-6298 765-423-6293 St. Elizabeth Medical Center 2209 Genesee Street Utica NY 13501 315-734-3335 315-734-3072 St. Francis Health Center 1700 SW 7th Street Topeka KS 66605 785-295-7828 785-231-5992 St. Francis Hospital One St. Francis Drive Greenville SC 29601 864-255-1079 864-255-1762 St. Francis Hospital 701 N. Clayton Street Wilmington DE 19805 302-421-4395 302-421-4397 St. Francis Hospital 333 Laidley Street PO Box 44 Culloden, WV 25510 Charleston WV 25322 304-347-6500 ext. 6675 304-347-6153 St. Francis Hospital 100 Port Washington Boulevard Roslyn NY 11576 516-562-6252 516-562-6178 St. Francis Medical Center 211 Saint Francis Drive Cape Girardeau MO 63703-5049 573-331-5286 573-331-5023 St. Francis Medical Center 3630 Imperial Highway Lynwood CA 90265 310-900-8641 310-885-5938 St. Francis Medical Center 309 Jackson Street Monroe LA 71201 318-327-5243 318-327-4144 St. Francis Medical Center 601 Hamilton Avenue Trenton NJ 08629 609-599-5771 609-599-5715 St. Francis North Hospital 309 Jackson Street Monroe LA 71201 318-327-5243 St. Helena Hospital 10 Woodland Road St. Helena CA 94574 707-967-6325 707-967-5744 St. James Health Care 400 South Clark Street Butte MT 59701 406-723-2794 St. John Medical Center 1923 S. Utica Avenue Heart Institute Education/Research Tulsa OK 74104 918-744-2825 918-744-3281 St. John Medical Center 1615 Delaware Street Longview WA 98632 360-636-4823 360-414-2739 St. John Providence Hospital 16001 W. Nine Mile Road Southfield MI 48075 248-849-2076 248-849-2853 St. John West Shore Hospital 29000 Center Ridge Road Westlake OH 44145 440-827-5506 440-827-5110 St. John's Hospital 800 E. Carpenter Street Springfield IL 62769 217-544-6464 x47139 217-535-3885 St. John's Hospital 1235 East Cherokee Street Springfield MO 65804 417-820-7523 417-820-7786 St. John's Pleasant Valley Hospital 2309 Antonio Avenue Camarillo CA 93010 805-988-2500 x2099 805-981-4403 St. John's Queens Hospital 90-02 Queens Boulevard Elmhurst NY 11373 718-558-0032 718-558-1878 St. Johns Regional Medical Center 2727 McClelland Boulevard Joplin MO 64804 417-625-2215 417-659-6704 St. Johns Regional Medical Center 1600 N. Rose Avenue Oxnard CA 93030-3722 805-988-2500 x2099 805-981-4403 St. John's Riverside Hospital 967 North Broadway Health Information Services Yonkers NY 10701 914-964-4350 914-964-4929 St. Joseph Hospital 172 Kinsley Street Nashua NH 03060 603-882-3000 x67117 St. Joseph Hospital 360 Broadway Bangor ME 04401 207-262-1403 207-262-2422 St. Joseph Hospital 1 Saint Joseph Drive Lexington KY 40504 859-313-2395 859-313-4337 St. Joseph Hospital 2901 Squalicum Parkway Bellingham WA 98225 360-734-5400 x3504 360-738-6733 St. Joseph Intercommunity Hospital 2605 Harlem Road Cheektowaga NY 14225 716-891-2683 716-891-2688 St. Joseph Medical Center 12th & Walnut Streets Reading PA 19603 610-378-2340 610-378-2530 St. Joseph Medical Center 1401 St. Joseph Parkway Houston TX 77002 713-757-7418 713-757-7420 St. Joseph Medical Center 7601 Olser Drive Towson MD 21204 410-337-1509 410-337-3947 St. Joseph Mercy Hospital 5325 Elliot Drive Ann Arbor MI 48106 734-712-2728 734-712-8689 St. Joseph Reg. Medical Center 801 E. Lasalle Avenue South Bend IN 46617 574-237-7979 574-282-8960 St. Joseph Regional Medical Center 703 Main Street Paterson NJ 07503 973-754-3559 973-754-2342 St. Joseph's Hospital 11705 Mercy Boulevard Savannah GA 31419 912-819-5291 912-691-9066 St. Joseph's Hospital 350 N. Wilmot Road Tucson AZ 85711 520-696-2529 St. Joseph's Medical Center 127 S. Broadway Yonkers NY 10701 914-378-7499 914-965-4838 St. Josephs Medical Center of Stockton 1805 North California Street Suite 303 Suite #303 Stockton CA 95204 209-461-5375 209-461-3462 St. Josephs Mercy Health Center 300 Werner Drive Hot Springs AR 71913 501-622-1489 501-622-2334 St. Jude Medical Center 101 East Valencia Mesa Fullerton CA 92835 714.992.3000 ext. 5346 714.446.5120 St. Luke Hospital East 85 N. Grand Avenue Ft. Thomas KY 41075 859-572-3905 859-572-2355 St. Luke Hospital West 7380 Turfway Road Florence KY 41042 859-962-5200 St. Luke's Baptist Hospital 7830 Floyd Curl Drive San Antonio TX 78229 210-297-1264 210-297-0926 St. Luke's Community Medical Center (The Woodlands) 17200 St. Luke's Way The Woodlands TX 77384 936-266-3964 936-266-2009 St. Luke's Episcopal Hospital 3100 Main Street MC5-313 Houston TX 77030 832-355-7276 832-355-3965 St. Lukes Hospital 363 Higland Avenue Falls River MA 02720 508-679-7159 St. Lukes Hospital 5901 Monclova Road Maumee OH 43537 419-893-5951 419-897-8381 St. Luke's Hospital 915 E. First Street Duluth MN 55805 218-249-6024 218-249-5110 St. Luke's Hospital & Health Network 801 Ostrum Street Bethlehem PA 18015 610-954-4630 610-954-4631 St. Luke's Hospital and Health Network (Allentown Campus) 1736 Hamilton Boulevard Allentown PA 18104 610-954-4640 610-954-2537 St. Luke's Hospital—Mayo Clinic 4201 Belfort Road Jacksonville FL 32216 904-296-4125 St. Luke's Medical Center 2901 West Oklahoma Avenue Milwaukee WI 53215-4330 414-649-6807 St. Luke's South Hospital 12300 Metcalf Avenue Overland Park KS 66213 913-317-7494 St. Luke's—Roosevelt Hospital Center 1111 Amsterdam Avenue New York City NY 10025 212-523-3755 212-523-2991 St. Mark's Hospital/ Northern Utah Healthcare Corporation 6985 Union Park Center Cottonwood Heights UT 84047 801-268-7265 St. Mary Hospital 1201 Langhorne Newton Road Langhorne PA 19047 215-710-5735 St. Mary Medical Center 18300 Highway 18 Appple Valley CA 92307 760-946-8165 760-946-8867 St. Mary Medical Center 1050 Linden Avenue Long Beach CA 90813-3321 562-491-9052 562-491-9795 St. Mary Medical Center 1500 South Lake Park Avenue Hobart ID 46342 219-947-6767 219-947-6769 St. Mary of Nazareth Hospital Center 2233 W. Division Street Chicago IL 60622 312-770-2244 312-770-2030 St. Mary's Health Center 6420 Clayton Road St. Louis MO 63117 314-768-8874 314-768-7122 St. Mary's Hospital 707 S. Mills Street Madison WI 53715-1849 608-259-3473 608-229-7178 St. Mary's Hospital 1800 East Lake Shore Drive Decatur IL 62521 217-464-2402 St. Mary's Hospital (Passaic) 350 Boulevard Passaic NJ 07055 973-365-4323 973-365-4375 St. Mary's Medical Center 901 45th Street West Palm Beach FL 33407 561-882-2710 St. Mary's Medical Center 450 Stanyan Street San Francisco CA 94117 415-750-5551 415-750-5825 St. Mary's Medical Center 900 E. Oak Hill Avenue Knoxville TN 37917 865-545-8177 St. Mary's Medical Center 407 East Third Street Duluth MN 55805 218-786-4129 218-786-4834 St. Mary's of Michigan 800 S. Washington Avenue Saginaw MI 48601 989-907-8409 St. Michael's Medical Center 111 Central Avenue Newark NJ 07102 973-877-5153 St. Nicholas Hospital 3100 Superior Avenue Sheboygan WI 53081 920-451-7466 920-452-8336 St. Patrick Hospital and Health Sciences Center 500 W. Broadway Missoula MT 59802 406-329-5770 406-329-5652 St. Rose Hospital 27200 Calaroga Avenue Hayward CA 94539 510-264-4505 510-264-4213 St. Tammany Parish Hospital 1202 S. Tyler Street Covington LA 70433 985-898-4005 St. Vincent Charity Hospital 2351 East 22nd Street Cleveland OH 44115 216-363-2532 216-363-2783 St. Vincent Healthcare 1233 N. 30th Street Billings MT 59101 406-237-4360 406-237-4390 St. Vincent Hospital 810 St. Vincents Drive Birmingham AL 35205 205-939-7814 205-930-2689 St. Vincent Medical Center 2131 W. 3rd Street Los Angeles CA 90703 213-207-5667 St. Vincent's Medical Center 1800 Barrs Street Jacksonville FL 32204 904-308-3863 St. Vincent's East 50 Medical Park East Drive Birmingham AL 35235-3499 205-838-3463 205-838-3708 Stacia Hansen 45 Reade Place Poughkeepsie NY 12601 845-437-3180 845-437-3144 Stanford Hospital and Clinics Falk Building 2nd Floor 300 Pasteur Drive Stanford CA 94305 650 736-7920 650 725-3846 Staten Island University Hospital 475 Seaview Avenue Staten Island NY 10305 718-226-1719 718-226-1733 Stony Brook University Medical Center 3 Technology Drive East Setauket NY 11733-4073 631-444-5289 Stormont-Vail Regional Medical Center 929 SW Mulvane Street Topeka KS 66606 785-270-4103 785-270-4105 Straub Clinic & Hospital: Cath Lab 888 S. King Street Honolulu HI 96813 808-522-3626 808-522-2370 Stringfellow Memorial Hospital 301 East 18th Street Anniston AL 36202 256-235-8935 Suburban Hospital 8600 Old Georgetown Road Bethesda MD 20814 301-896-2857 301-493-4259 Summerlin Hospital Medical Center 657 Town Center Drive Las Vegas NV 89144 Summit Healthcare Regional Medical Center 2200 East Show Low Lake Road Show Low AZ 85901 928-537-6518 Summit Medical Center East Main & South 20th Streets Van Buren AR 72956 479-471-4435 Sun Coast Hospital 2025 Indian Rocks Road S Largo FL 33774-1096 727-586-7124 Sun Health Boswell Hospital 10401 West Thunderbird Boulevard Sun City AZ 85351 623-875-6560 623-815-6095 Sunrise Hospital and Medical Center 3186 S. Maryland Parkway Las Vegas NV 89109 702-892-3695 Sutter Delta Medical Center 3901 Lone Tree Way Antioch CA 94509 925-779-3092 Sutter Medical Center—Sacramento 5151 F Street 1 South Transplant & Heart Specialty Clinics Sacramento CA 95819 916-733-0909 Sutter Medical Center of Santa Rosa 3325 Chanate Road Santa Rosa CA 95404 707-576-4093 707-576-5550 Swedish American Hospital 1401 E. State Street Rockford IL 61104 815-961-2382 815-489-4069 Swedish Covenant Hospital 5145 N. California Avenue Chicago IL 60625 773-878-8200 x5702 Swedish Health Services 500 17th Avenue #A85C Seattle WA 98104 206-386-6057 Swedish Medical Center 501 East Hampden Avenue Englewood CO 80113 303-788-4804 303-788-5085 T. J. Samson Community Hospital 1301 North Race Street Glasgow KY 42141 270-651-4868 Tacoma General Hospital 315 Martin Luther King, Jr. Way Tacoma WA 98415 253-403-3437 253-403-2461 Tahlequah City Hospital 1400 East Downing Street Tahlequah OK 74465-1008 918-453-2155 Tallahassee Memorial Hospital 1300 Miccosukee Road Attn: Performance Improvement Tallahassee FL 32308 850-431-4942 850-431-4949 Tampa General Hospital PO Box 1289 Tampa FL 33601-1289 813-844-4352 813-844-7963 Temple University Hospital 3401 North Broad Street 1st Floor Room B-150 Philadelphia PA 19140 215-707-5501 215-707-3535 Terre Haute Regional Hospital 3901 South 7th Street Terre Haute IN 47802 812-237-9866 812-237-1365 Terrebonne General Medical Center 8166 Main Street Houma LA 70360 985-873-4189 985-873-4256 Texoma Medical Center 1000 Memorial Drive Denison TX 75020 903-416-4120 TexSAn Heart Hospital 6700 IH-10 West San Antonio TX 78201-2009 210-736-8008 210-736-8400 The Christ Hospital 2139 Auburn Avenue Cincinnati OH 45219 513-585-2840 513-585-3296 The George Washington University Hospital 900 23rd Street, NW Washington DC 20037 202-715-5320 202-715-5083 The Heart Hospital Baylor Plano 1100 Allied Drive Plano TX 75093 469-814-3530 The Heart Hospital of Northwest Texas 1501 S. Coulter Street PO Box 1110 Amarillo TX 79175 806-351-5837 806-351-5147 The Hospital at WestlakeMedical Center 5656 Bee Caves Road M-302 Austin TX 78746 512-697-3582 512-697-3583 The Indiana Heart Hospital 8075 North Shadeland Avenue Indianapolis ID 46250 317-621-8723 317-621-8706 The Medical Center

(TMC)1000 Dutch Ridge Road Beaver PA 15009 724-773-8225 The Medical Center of Southeast Texas 2555 Jimmy Johnson Boulevard Port Arthur TX 77640 409-853-5356 409-853-5355 The Methodist DeBakey Heart Center 6565 Fannin Street Houston TX 77030 713-441-2592 The Monroe Clinic 515 22nd Avenue Monroe WI 53566 608-324-1327 608-324-1722 The Mount Sinai Hospital of Queens 25-11 30th Avenue Long Island City NY 11102 718-267-4226 The Mount Sinai Medical Center The Mount Sinai Medical Center New York NY 10029 212-241-7272 212-534-2776 The Nebraska Medical Center 987551 Nebraska Medical Center Omaha NE 68198 402-552-2314 402-552-2789 The Reading Hospital and Medical Center Sixth Avenue and Spruce Street West Reading PA 19611 610-988-8923 610-988-8636 The Toledo Hospital 2142 North Cove Boulevard Jobst Tower Suite 200 Toledo OH 43606 419-291-5968 The Valley Hospital 223 North Van Dien Avenue Ridgewood NJ 07450 201-291-6037 201-291-6046 The Washington Hospital 155 Wilson Avenue Washington PA 15301-3398 724-223-3570 The Western Pennsylvania Hospital 4800 Friendship Avenue CVI Pittsburgh PA 15224 412-578-5366 412-578-4624 The Wisconsin Heart Hospital, Inc WFH Clinical Data Management and Analysis 5000 West Chambers, M229 Milwaukee WI 53210 414-447-2727 414-874-4386 Thomas Jefferson University Hospital TJUH 111 S. 11th Street Gibbon Building Philadelphia PA 19107 215-955-2532 215-923-4942 Tift Regional Medical Center PO Box 747 901 E. 18th Street Tifton GA 31794 229-353-6762 229-353-6098 Tobey Hospital 363 Highland Avenue Fall River MA 508-679-7153 Tomball Regional Hospital 605 Holderrieth Boulevard Tomball TX 77375 281-401-7553 281-357-2274 Torrance Memorial Medical Center 3330 Lomita Boulevard Torrance CA 90505 310-784-4937 310-784-3775 Tri-City Medical Center 4002 Vista Way Oceanside CA 92056 760-940-7802 Trident Regional Medical Center 9330 Medical Plaza Drive Charleston SC 29406 843-847-4981 843-847-4169 Trinity Hospitals PO Box 5020 Minot ND 58702 701-857-5766 701-857-3576 Trinity Medical Center Attn: CardioVascular Services 800 Montclair Road Birmingham AL 35213 205-592-5623 Trinity Medical Center 4602 3rd Street Moline IL 61265 309-779-3902 309-779-5222 Trinity Medical Center West 4000 Johnson Road Steubenville OH 43952 740-264-8192 740-264-8654 Trinity Regional Medical Center 802 Kenyon Road Fort Dodge IA 50501 515-574-6459 515-574-6036 Trinity Regional Medical Center 4602 3rd Street Moline IL 61265 309-779-3902 309-779-5222 Tucson Heart Hospital 4888 North Stone Avenue Tucson AZ 85704 520-696-2529 Tucson Medical Center 5301 E. Grant Road Tucson AZ 85712 520-324-3527 Tufts Medical Center 750 Washington Street Boston MA 02111 617-636-2811 Tulane Medical Center 1415 Tulane Avenue New Orleans LA 70112 504-988-1407 504-799-7973 Tuomey Healthcare System Tuomey Regional Medical Center 129 N. Washington Street Sumter SC 29150 803-778-9450 UC San Diego Medical Center 200 W. Arbor Drive San Diego CA 92103 619-543-5726 UMASS Memorial Medical Center 55 Lake Ave North Worcester MA 01655-0002 508-334-7361 508-856-6571 Union Hospital 1606 N. 7th Street Terre Haute IN 47804 812-238-7582 Union Memorial Hospital 201 E. University Parkway Baltimore MD 21218-2891 410-554-6550 410-554-6599 United Health Services Hospitals/Wilson Regional Medical Center 33-57 Harrison Street Decker 4 Lobby Johnson City NY 13790 607-763-6197 607-763-5335 United Hospital 333 N. Smith Avenue St. Paul MN 55102 651-241-8544 651-241-2666 United Hospital Center, Inc. PO Box 1680 Clarksburg WV 53143 262-656-3110 262-656-3141 United Hospital System 6308 8th Avenue Kenosha WI 53143 262-656-3110 262-656-3141 United Regional Healthcare System 1600 11th Street Wichita Falls TX 76301 940-764-2850 940-764-2865 Unity Health Center 1102 West MacArthur Shawnee OK 74804 405-878-3486 405-878-3484 Unity Hospital 550 Osbourne Road NE Minneapolis MN 55432 612-262-6028 612-262-4370 Unity Hospital 1555 Long Pond Road Rochester NY 14626 585-723-7312 585-368-4973 University Community Hospital 3100 East Fletcher Avenue Tampa FL 33613 813-615-7845 813-615-8107 University Community Hospital Carrollwood Campus 3100 East Fletcher Avenue Tampa FL 33613 813-615-7845 813-615-8107 University Hospital 620 19th Street South Birmingham AL 35249 205-934-8716 205-924-8720 University Hospital 234 Goodman Street Cincinnati OH 45219 513-584-0295 513-584-2242 University Hospital 1350 Walton Way Augusta GA 30901 706-774-7764 706-774-7640 University Hospitals Bedford Medical Center 44 Blaine Avenue Bedford OH 44146 440-735-3526 440-735-3527 University Hospitals Case Medical Center 11100 Euclid Avenue Cleveland OH 44106 216-844-7924 216-844-1419 University Hospitals Geauga Medical Center 13207 Ravenna Road Chardon OH 44024 440-285-6372 440-285-3230 University Hospitals Richmond Medical Center 27100 Chardon Road Richmond Heights OH 44143 440-585-6115 440-585-6293 University Hospital UMDNJ 150 Bergen Street Newark NJ 07101 973-972-1662 973-972-7414 University Medical Center 1501 N. Campbell Avenue Tucson AZ 85724 520-694-6899 520-694-2617 University Medical Center 602 Indiana Avenue Lubbock TX 79410 806-775-9274 University Medical Center LSU 2390 W. Congress Street Lafayette IA 70506 337-261-6333 337-261-6334 University Medical Center of Las Vegas 1800 W. Charleston Boulevard Las Vegas NV 89102 702-383-2348 702-383-2658 University of Califorina, Irvine Division of Cardiology 101 The City Drive Orange CA 92868 714-456-5984 University of California

(UCLA)18033 Le Conte Avenue Los Angeles CA 90095 310-825-6536 University of California Davis Medical Center 2315 Stockton Boulevard Main Hospital, Rm 6312 Sacramento CA 95817 916-734-7279 916-734-5378 University of California San Francisco Medical Center 505 Parnassus Avenue L-523 Box 0210 San Francisco CA 94143-0210 415-353-7832 415-353-8713 University of Chicago Hospitals 5841 S. Maryland Avenue Chicago IL 60637 773-834-0283 773-834-5923 University of Colorado Hospital Authority 16205 E. 16th Avenue Box 132 Aurora CO 80045 720-848-7546 University of CT Health Center/John Dempsey Hospital 263 Farmington Avenue Farmington CT 06030 860-679-4117 860-679-4256 University of Florida (Shands)College of Medicine 1600 SW Archer Road Gainesville FL 32610 352-265-0119 352-265-0314 University of Illinois Medical Center at Chicago 1740 W. Taylor Street Bld 949 Rm 2181 Chicago IL 60610 312-996-3839 312-413-7904 University of Iowa Hospitals and Clinics 200 Hawkins Drive Iowa City IA 52242 319-353-6810 University of Kentucky 800 Rose Street Lexington KY 40536 859-323-4738 859-257-7383 University of Louisville Hospital 530 S. Jackson Street Loiusville KY 40202 502-562-3715 University of Maryland Medical Center Cardiology 22 S. Greene Street Baltimore MD 21201-1544 410-328-1044 410-328-1717 University of Minnesota Medical Center Fairview 420 Delaware Street SE MMC 815 Minneapolis MN 55455 612-273-5592 612-273-8467 University of Mississippi Medical Center 2500 N. State Street Jackson MS 39216 601-984-2250 301-984-2631 University of Missouri Hospital and Clinics 1 Hospital Drive Columbia MO 65212 573-882-2297 573-884-1999 University of North Carolina Hospitals UNC Hospitals 101 Manning Drive CB#7075 Chapel Hill NC 27514 919-966-9421 919-966-6955 University of Rochester Medical Center 601 Elmwood Avenue Rochester NY 14642 585-273-4453 University of South Alabama Cardiology Department 2451 Fillingim Street Mobile AL 36617 251-471-7361 251-470-1685 University of Tennessee Medical Center 1924 Alcoa Highway Knoxville TN 37920-6999 865-544-9785 865-525-3742 University of Texas Medical Branch at Galveston 301 University Boulevard Galveston TX 77555-0294 409-747-2194 409-772-5141 University of Texas Southwestern—University Hospital 5323 Harry Hines Boulevard Dallas TX 75390-9013 214-645-5552 214-645-5537 University of Toledo Medical Center 3065 Arlington Avenue DH2261 Toledo OH 43614 419-383-5150 419-383-3149 University of Utah Hospitals and Clinics 50 North Medical Drive Salt Lake City UT 84132 801-585-9940 University of Virginia Medical Center PO Box 800679 Charlottesville VA 22908-0679 434-243-6825 434-982-3885 University of Washington Medical Center 1959 NE Pacific Street Seattle WA 98195-6422 206-598-0531 University of Wisconsin Hospital & Clinics 600 Highland Avenue MC 3204 Madison WI 53792 608-890-8618 UPMC Mercy 1400 Locust Street Pittsburgh PA 15219 412-232-8440 UPMC Passavant Hospital 9100 Babcock Boulevard Pittsburgh PA 15237 412-635-3878 UPMC Presbyterian Hospital 5230 Centre Avenue Pittsburgh PA 15232 412-623-6233 412-623-0051 UPMC Shadyside Hospital 5230 Centre Avenue Pittsburgh PA 15232 412-623-6233 412-623-6228 Upper Chesapeake Medical Center, Inc 500 Upper Chesapeake Drive Bel Air MD 21014 443-643-2449 443-643-4917 Upstate Medical University

(SUNY)750 East Adams Street Syracuse NY 13120 315-464-4232 315-464-7101 USC University Hospital 1500 San Pablo Street Los Angeles CA 90033 323-442-8479 Utah Valley Regional Medical Center 1034 S. 500 W Provo UT 84605 801-357-3613 Val Verde Regional Medical Center 801 Bedell Avenue Del Rio TX 78840 830-778-3656 830-778-3656 Valley Baptist Medical Center 2101 Pease Street Harlingen TX 78550 956-389-1102 956-389-6763 Valley Care Medical Center 1111 East Stanley Boulevard Livermore CA 94550 925-734-3335 925-416-3544 Valley Hospital Medical Center 620 Shadow Lane Las Vegas NV 89106 702-894-5743 Valley Medical Center 400 South 43rd Street Renton WA 98058 425.228.3440 X5965 Valley Presbyterian Hospital 15107 Vanowen Street Van Nuys CA 91405 818-904-3742 818-902-5206 Valley Regional Medical Center Valley Regional Medical Center 100A East Alton Gloor Building Brownsville TX 78526 956-350-7327 956-350-7723 Valley View Medical Center 5330 S. Highway 95 Fort Mohave AZ 86427 928 788 7248 928-788-7869 Vanderbilt Heart Institute 1215 21st Avenue MCE 5th floor Nashville TN 37232 615-343 8231 Vaughan Regional Medical Center 1015 Medical Center Parkway Selma AL 36701 334-418-4461 334-418-3588 VCU—Medical College of Virginia PO Box 980036 Richmond VA 23298 804-828-9005 804-828-4528 Venice Regional Medical Center 540 The Rialto Venice FL 34285 941-483-7713 941-483-7220 Verde Valley Medical Center 269 South Candy Lane Cotttonwood AZ 86326 928-639-6486 928-639-6405 Verdugo Hills Hospital 1812 Verdugo Boulevard Glendale CA 91208 812-952-2243 Via Christi Wichita Health Network 929 N. St. Francis Street Wichita KS 67214 316-268-6763 Ville Platte Medical Center 800 East Main Street Ville Platte LA 70586 337-363-9447 Virginia Hospital Center 1701 N. George Mason Drive Arlington VA 22205-3698 703-558-6678 703-558-6728 Virginia Mason Medical Center 1100 Ninth Avenue X3-CVL Seattle WA 98111 206-341-0530 206-223-6695 W. A. Foote Memorial Hospital Charles Anderson Building Level 4 205 N. East Avenue Jackson MI 49201 517-788-7880 x3450 517-780-7208 Wadley Regional Medica Center 1000 Pine Street Texarkana TX 75501 903-798-7420 903-798-7428 WakeMed Cary Hospital 3128 Smoketree Court Raleigh NC 27604 919-350-2998 WakeMed Raleigh Campus 3000 New Bern Avenue Raleigh NC 27610 919-350-6357 919-350-8972 Walker Regional Medical Center 3400 Highway 78 E Jasper AL 35501 205-387-4009 Washington Adventist Hospital 7600 Carroll Avenue Takoma Park MD 20912 301 891-5901 301-891-6365 Washington County Hospital 251 East Antietam Street Hagerstown MD 21740 301-790-8665 Washington Hospital 2000 Mowry Avenue Fremont CA 94538 510-745-6504 Washington Hospital Center 110 Irving Street NW Rm 5A14 Washington DC 20010 202-877-7687 202-877-2566 Washington Regional Medical Center 1125 N College Avenue Fayetteville AR 72703-1994 Waterbury Hospital PO Box 2153 Waterbury CT 06722-2153 203-575-5572 203-575-5575 Watsonville Community Hospital 75 Nielson Street Watsonville CA 95076 831-761-5696 831-728-4758 Waukesha Memorial Hospital 725 American Avenue Waukesha WI 53188 262-928-2621 262-928-2775 Weatherford Regional Medical Center 713 East Anderson Street Weatherford TX 76086 817-599-1845 817-599-1162 Weiss Memorial Hospital 4646 N. Marine Drive Chicago IL 60640 773-564-5917 773-564-5911 Wellmont Holston Valley Medical Center 130 W Ravine Road Kingsport TN 37660 423-224-6529 423-224-6540 Wellstar Cobb Hospital 531 Roselane Street Marietta GA 30060 770-793-5218 677-331-6959 Wellstar Kennestone Hospital 677 Church Street Marietta GA 30066 770-793-5218 678-331-6959 Wesley Medical Center 550 N. Hillside Street Wichita KS 67214 316-962-3230 Wesley Medical Center 5001 Hardy Street Hattiesburg MS 39402 601-268-8526 West Anaheim Medical Center 3033 West Orange Avenue Anaheim CA 92084 714-229-4081 West Florida Hospital 8383 Davis Highway Pensacola FL 32514 850-494-4028 850-494-4867 West Hills Hospital 7300 Medical Center Drive West Hills CA 91307 818-676-4106 818-676-4323 West Houston Medical Center 12141Richmond Avenue Houston TX 77082 281-588-8248 281-596-5915 West Jefferson Medical Center 1101 Medical Center Boulevard Marrero LA 70072 504-349-1417 West Suburban Medical Center 3 Erie Court Oak Park Il 60302 708-763-2572 708-763-1591 West Valley Hospital 13677 W. McDowell Road Goodyear AZ 85338 623-882-1818 623-882-1510 West Virginia University Hospitals, Inc. PO Box 8003 Medical Center Drive Morgantown WV 26506-8003 304-598-6121 304-598-4277 Westchester County Medical Center 95 Grasslands Road Suite 114 Valhalla NY 10595 914-493-5319 Western Arizona Regional Medical Center 2735 Silver Creek Road Bullhead City AZ 86442 928-763-2273 Western Baptist Hospital 2501 Kentucky Avenue Paducah KY 42003 270-575-2300 270-575-8486 Western Medical Center Santa Ana 1001 North Tustin Avenue Santa Ana CA 92705 714-953-2501 714-953-3481 Western Plains Medical Center 3001 Avenue A Dodge City KS 67801 620-225-8402 Westside Regional Medical Center 8201 West Broward Boulevard Plantation FL 33324 954-370-4445 954-577-2485 Wheaton Franciscan Healthcare—All Saints, Inc. WFHC Clinical Data Management and Analysis 5000 West Chambers, M229 Milwaukee WI 53210 414-447-2727 414-874-4386 Wheaton Franciscan Healthcare—St. Francis, Inc. WFHC Clinical Data Management and Analysis 5000 West Chambers, M229 Milwaukee WI 53210 414-447-2727 414-874-4386 Wheaton Franciscan Healthcare—St. Joseph, Inc. WFH Clinical Data Management and Analysis 5000 West Chambers, M229 Milwaukee WI 53210 414-447-2727 414-874-4386 Wheeling Hospital 1 Medical Park Wheeling WV 26003 304-243-3089 304-243-6400 White County Medical Center 3214 E. Race Avenue Searcy AR 72143-4810 501-380-3102 501-380-3101 White Memorial Medical Center 1720 Cesar E. Chavez Avenue Los Angeles CA 90033 323-268-5000 323-881-8872 White River Medical Center 1710 Harrison Street Batesville AR 72501 870-262-6150 870-262-3170 William Beaumont Hospital 3601 West Thirteen Mile Road Royal Oak MI 48073 248-898-4015 William Beaumont Hospita—Troy 44201 Dequindre Road Troy MI 48085 248-964-6874 248-964-6801 William W. Backus Hospital 326 Washington Street Norwich CT 06360 860-889-8331 860-425-3828 Willis-Knighton Medical Center 2600 Greenwood Road Shreveport LA 71103 318-212-8576 318-212-4307 Wilson Memorial Hospital 915 West Michigan Street Sidney OH 45365 937-498-5524 937-498-5536 Wilson N. Jones Medical Center 500 N Highland Avenue Sherman TX 75092 903-870-5516 903-870-5520 Winchester Medical Center Inc. 220 Campus Boulevard Suite 313 Winchester VA 22601 540-536-4750 540-536-6879 Winter Haven Hospital 20005 Avenue F Northeast Winter Haven FL 33881 863-293-1121 x3560 863-292-4123 Winthrop—University Hospital 259 First Street Mineola Ny 11501 516-663-2476 516-663-2926 Wise Regional Health System 609 Medical Center Drive Decatur TX 76234 940-627-5921 x3766 940-626-1387 Wishard Health Services Attn: A/P 1001 W. 10th Street Indianapolis IN 46202 317-630-7203 Woman's Christian Association Hospital 207 Foote Avenue Jamestown NY 14701 716-664-8172 716-664-8241 Woodland Heights Medical Center 505 S. John Redditt Drive Lufkin TX 75904 936-637-8520 936-637-8519 Wuesthoff Health System 110 Longwood Avenue Rockledge FL 32956-5002 321-636-2211 x1095 Wyckoff Heights Medical Center 374 Stockholm Street Division of Cardiology—3rd Floor Brooklyn NY 11237 718-486-4278 718-963-6396 Wyoming Medical Center 1233 East 2nd Street Casper WY 82601-2988 307-577-2548 307-577-5018 Wyoming Valley Health Care System 575 North River Street Wilkes-Barre PA 18764 570-552-4415 570-552-4416 Yakima Regional Medical Center/Cardiac Center 110 S. 9th Avenue Yakima WA 98902 509-454-6508 Yakima Valley Memorial Hospital 2811 Tieton Drive Yakima WA 98902 509-249-5381 509-574-5800 Yale New Haven Hospital 20 York Street New Haven CT 06510 Yavapai Regional Medical Center 1003 Willow Creek Rd Prescott AZ 86301 928-771-5610 928-771-5615 York Hospital 15 Hospital Drive York ME 03909 207-351-3421 207-351-3427 York Hospital 1001 South George Street York PA 17405 717-851-4554 717-851-4206 Yuma Regional Medical Center 2400 S. Avenue A Yuma AZ 85364 928-336-7055 928-336-7487 Addendum X—Active CMS Coverage-Related Guidance Documents [January Through March 2008] On September 24, 2004, we published a notice in the **Federal Register** (69 FR 57325), in which we explained how we would develop coverage-related guidance documents. These guidance documents are required under section 731 of the MMA. In our notice, we committed to the public that, “At regular intervals, we will update a list of all guidance documents in the **Federal Register** .” Addendum X includes a list of active CMS guidance documents as of the ending date of the period covered by this notice. To obtain full-text copies of these documents, visit the CMS Coverage Web site at *http://www.cms.hhs.gov/mcd/index_list.asp?list_type=mcd_1* . *Document Name:* Factors CMS Considers in Commissioning External Technology Assessments. *Date of Issuance:* April 11, 2006. *Document Name:* Factors CMS Considers in Opening a National Coverage Determination. *Date of Issuance:* April 11, 2006. *Document Name:* (Draft) Factors CMS Considers in Referring Topics to the Medicare Coverage Advisory Committee. *Date of Issuance:* March 9, 2005. *Document Name:* National Coverage Determinations with Data Collection as a Condition of Coverage: Coverage With Evidence Development. *Date of Issuance:* July 12, 2006. Addendum XI—List of Special One-Time Notices Regarding National Coverage Provisions [January Through March 2008] As medical technologies, the contexts under which they are delivered, and the health needs of Medicare beneficiaries grow increasingly complex, our national coverage determination

(NCD)process must adapt to accommodate these complexities. As part of this adaptation, our national coverage decisions often include multi-faceted coverage determinations, which may place conditions on the patient populations eligible for coverage of a particular item or service, the providers who deliver a particular service, or the methods in which data are collected to supplement the delivery of the item or service (such as participation in a clinical trial). We outline these conditions as we release new or revised NCDs. However, details surrounding these conditions may need to be shared with the public as “one-time notices” in the **Federal Register** . For example, we may require that a particular medical service may be delivered only in the context of a CMS-recognized clinical research study, which was not named in the NCD itself. We would then use Addendum XI of this notice, along with our coverage Web site at *http://www.cms.hhs.gov/coverage* , to provide the public with information about the clinical research study that it ultimately recognizes. Addendum XI includes any additional information we may need to share about the conditions under which an NCD was issued as of the ending date of the period covered by this notice. There were no Special One-Time Notices Regarding National Coverage Provisions published this quarter. Addendum XII—National Oncologic PET Registry

(NOPR)In January 2005, we issued our decision memorandum on positron emission tomography

(PET)scans, which stated that CMS would cover PET scans for particular oncologic indications, as long as they were performed in the context of a clinical study. We have since recognized the National Oncologic PET Registry as one of these clinical studies. Therefore, in order for a beneficiary to receive a Medicare-covered PET scan, the beneficiary must receive the scan in a facility that participates in the Registry. The following facilities have met the CMS's requirements for performing PET scans under National Coverage Determination CAG-00181N. Facility name Provider number Date approved State Other information Barnes-Jewish Hospital, Barnes-Jewish Plaza, Mailstop # 90-72-374, St. Louis, MO 63110 E40080o 03/07/2006 MO Duke University Medical Center PET Facility, Room 0402 Duke So., Durham, NC 27710 34003 03/07/2006 NC Yellow Zone Box 3949. VCU Health System—Molecular Imaging Center, Dept of Nuclear Medicine—North Hospital 7th Floor, Richmond, VA 23298 490032 03/07/2006 VA 1300 East Marshall—PO Box 980001. Acadiana Oncologic Imaging, 2311 Kaliste Saloom, Lafayette, LA 70508 5CA64 03/06/2006 LA Adler Institute for Advanced Imaging, 261 Old York Road, Suite 106, Jenkintown, PA 19046 03/07/2006 PA Advanced Medical Imaging San Saba, 215 N San Saba, Suite 107, San Antonio, TX 78207 00BC90 03/07/2006 TX Advanced Medical Imaging Stone Oak, 540 Oak Centre, Suite 100, San Antonio, TX 78258 00BC90 03/07/2006 TX Advanced Radiological PET Imaging, PC, 2334 30th Avenue, Astoria, NY 11102 05677 03/07/2006 NY Lower Level. Akron Regional PET Scan, LLC, 3009 Smith Road, Suite 350, Akron, OH 44333 AKID01691 03/07/2006 OH American Radiology Services—Owings Mills, 21 Crossroads Drive, Suite 100, Owings Mills, MD 21117, 434L 03/07/2006 MD American Radiology Services—Bethesda, 6430 Rockledge Drive, Suite 100, Bethesda, MD 20817 G00000 03/07/2006 MD American Radiology Services—Waldorf, 3510 Old Washington Road, Suite 101, Waldorf, MD 20602 435L 03/07/2006 MD American Radiology Services—Columbia, 8820 Columbia Parkway 100, Columbia, MD 21045, 434L 03/07/2006 MD American Radiology Services—Frederick, 141 Thomas Johnson Drive, Suite 170, Frederick, MD 21702 435L 03/07/2006 MD American Radiology Services—Timonium, 2080 York Road, Suite 160, Timonium, MD 21093 434L 03/07/2006 MD Angel Williamson Imaging Center—Ft. Walton Beach, 1013-D Mar-Walt Drive, Ft. Walton Beach, FL 32547 39953A 03/07/2006 FL Angel Williamson Imaging Center—Pensacola, 5120 Bayou Boulevard, Suite 9, Pensacola, FL 32503 39953 03/07/2006 FL Edison Imaging Center, 3900 Park Avenue, Suite 107, Edison, NJ 08820 AS008835 03/07/2006 NJ Avon Medical Diagnostic Center, 1480 Center Road, Suite C, Avon, OH 44011 MC4039571 03/07/2006 OH Baltimore Imaging Centers, 3708 Mountain Road, Pasadena, MD 21122 H476 03/07/2006 MD Baptist Hospital PET/CT, 1000 West Moreno Street, Pensacola, FL 32501 100093 03/07/2006 FL Bethesda Health City, 2623 S Seacrest Boulevard, Boynton Beach, FL 33435 40237 03/07/2006 FL PET/CT Imaging at White Marsh, 9900 Franklin Square Drive, Suite D, Nottingham, MD 21236 FMNX01 03/07/2006 MD Biomedical Research Foundation PET Imaging Center, 1505 Kings Highway, Shreveport, LA 71103 5D914 03/07/2006 LA BodyScan of Louisville LLC, 807 Shelbyville Road, Suite 201, Louisville, KY 40222 9372701 03/07/2006 KY Bradley Regional PET Imaging, Cleveland, TN 37311 3373976 03/07/2006 TN 2305 Chambliss Ave NW. PET Imaging Institute of NJ, 1608 Rte 88 West, Suite 302, Brick, NJ 08724 070684 03/07/2006 NJ Broward PET Imaging Center, LLC, 4850 W. Oakland Park Boulevard, Suite A, Fort Lauderdale, FL 33313 E5709 03/07/2006 FL Camelback Imaging, 15215 S. 48th Street, #110, Phoenix, AZ 85044, 100488, 03/07/2006, AZ California Imaging and Treatment Center, 3000 Oak Road, #111, Walnut Creek, CA 95497 ZZZ27175Z 03/07/2006 CA Cancer Care Centers of Brevard, 1430 S Pine Street, Melbourne, FL 32901 39835 03/07/2006 FL Center for Medical Imaging—Florida Hospital, 1922 Salk Avenue, Tavares, FL 32778 100057 03/07/2006 FL Cancer Center of Colorado Springs, 320 E. Fontanero, Suite 200, Colorado Springs, CO 80907 79804 03/07/2006 CO Centro Sononuclear de Rio Piedras, 1028 Los Angeles Street, San Juan, PR 00926 83910 03/07/2006 PR Chattanooga Imaging East, 1710 Gunbarrel Road, Chattanooga, TN 37421 3716643 03/07/2006 TN Chester County PET Associates, 701 East Chester Marshall Street, West Chester, PA 19380 085698 03/07/2006 PA Cincinnati PET Scan, LLC—Kenwood, 7730 Montgomery Road, Suite 120, Cincinnati, OH 45236 311754291 03/07/2006 OH Cincinnati PET Scan, LLC Monfort Heights, 5575 Cheviot Road, Cincinnati, OH 45247 311754291 03/07/2006 OH Clinical PET of Hernando, 4003 Mariner Boulevard, Spring Hill, FL 34609 L13228 03/07/2006 FL Clinical PET of Citrus, 6140 W Corporate Oaks Drive, Crystal River, FL 34429 U0121 03/07/2006 FL Clinical PET of Lake City, 484 SW Commerce Drive, Suite 145, Lake City, FL 32025 V2683 03/07/2006 FL Clinical PET of Ocala, 3143 SW 32nd Avenue, Suite 100, Ocala, FL 34474 E7179 03/07/2006 FL Columbus Regional Hospital, 2400 East 17th Street, Columbus, IN 47201 150112 03/07/2006 IN Concord Imaging, 18802 Meisner Drive, San Antonio, TX 78258 00126Z 03/07/2006 TX Dartmouth Hitchcock Medical Center, One Medical Center Drive, Lebanon, NH 03756 03/07/2006 NH Dedicated PET Imaging, 2315 Sunset Boulevard, Suite E, Steubenville, OH 43952 01181 03/07/2006 OH Diablo Valley Oncology & Hematology Medical Group, 3000 Oak Road, #111, Walnut Creek, CA 94597 ZZZ26796Z 03/07/2006 CA Diagnostic Imaging at Baywalk, 129 1st Avenue N, St. Petersburg, FL 33701 00022 03/07/2006 FL DMS Imaging, 2101 N. University Drive, Fargo, ND 58109 03/07/2006 ND PO Box 8070. Doylestown PET Associates, 599 W. State Street, Doylestown, PA 18901 059536 03/07/2006 PA Suite 202. East Bay Medical Oncology-Hematology Assoc., Inc, 3000 Oak Road, #111, Walnut Creek, CA 94597 ZZZ267792 03/07/2006 CA East River Medical Imaging, 519 East 72 Street, Suite 103, New York, NY 10021 W11781 03/07/2006 NY El Camino Imaging Center, 8020 Constitution Place NE, Albequerque, NM 87110 237150 03/07/2006 NM Elite Imaging, LLC, 2845 Aventura Boulevard, Suite 145, Aventura, FL 33180 K3535 03/07/2006 FL EPIC Imaging Center, 233 NE 102nd Avenue, Portland, OR 97220 0000WCGNQ 03/07/2006 OR Evergreen Radia, 11521 NE 128th Street, Kirkland, WA 98034 GAB39931 03/07/2006 WA Excel Diagnostics Imaging Clinics, 9701 Richmond Avenue, Suite 122, Houston, TX 77042 FTA109 03/07/2006 TX First Imaging of the Carolinas, 30 Memorial Drive, Pinehurst, NC 29374 2346997 03/07/2006 NC Florida Hospital Advanced Nuclear Imaging PET, 328 Spruce Street, Orlando, FL 32804 100007 03/07/2006 FL Fort Jesse Imaging Center, LLC, 2200 Fort Jesse Road, Suite 120, Normal, IL 61761 209824 03/07/2006 IL Fox Chase Cancer Center, 333 Cotman Avenue, Philadelphia, PA 19111 390196 03/07/2006 PA Frederick Imaging Centers, 46B Thomas Johnson Drive, Frederick, MD 21702 H476 03/07/2006 MD Fusion Diagnostic Group, LLC, 1700 California Street, Suite 260, San Francisco, CA 94109 00G366470 03/07/2006 CA Fusion Imaging Institute, 2419 E. Commercial Boulevard, Suite 101, Ft. Lauderdale, FL 33308 18281 03/07/2006 FL Future Diagnostics Group, 254 N. Republic Avenue, Joliet, IL 60435 200825 03/07/2006 IL Greater Niagra PET, LLC, 1 Columbia Drive, Suite 3, Niagra Falls, NY 14305 BA0213 03/07/2006 NY Witmer Park Medical Center. Hematology Oncology Associates of Baton Rouge, 4950 Essen Lane, Baton Rouge, LA 70809 5C696 03/07/2006 LA Gulf Coast Cancer & Diagnostic of Southeast, 12811 Beamer Road, Houston, TX 77089 149949301 03/07/2006 TX Henry Ford, Department of Radiology, 2799 W. Grand Boulevard, Detroit, MI 48202 230053 03/07/2006 MI High Point Regional Health System, 601 N. Elm Street, High Point, NC 27262 3400040 03/07/2006 NC Highlands Oncology Group, 3232 N. North Hills Boulevard, Fayetteville, AR 27203 5B823 03/07/2006 AR Holy Name Hospital, 718 Teaneck Road, Teaneck, NJ 07666 310008 03/07/2006 NJ PET/CT Center. Holy Family Memorial Medical Center, PO Box 1450, Manitowoc, WI 54221 520107 03/07/2006 WI 2300 Western Ave. Hospital of Saint Raphael, 1450 Chapel Street, New Haven, CT 05611 070001 03/07/2006 CT San Patricio MRI & CT Center, 1508 Roosevelt Avenue, Suite 103, San Juan, PR 00920 84997 03/07/2006 PR Imaging Center of Hartford Hospital, 80 Seymour Street, PO Box 5037, Hartford, CT 06102 070025 03/07/2006 CT Indian Wells PET/CT Center, 74785 Highway 111, #101, Indian Wells, CA 92210 1264523891 03/07/2006 CA Imaging Technology Associates, 3800 Reservoir Road NW, Washington, DC 20007 FDNCX1 03/07/2006 DC Gorman 2043, PET Scan. San Francisco Magnetic Resonance Center, 1180 Post Street, San Francisco, CA 94109 ZZZ27498Z 03/07/2006 CA Intermountain Medical Imaging, 2929 E Magic View Drive, Meridian, ID 83642 82-05144-22 03/07/2006 ID Jefferson Center City Imaging, 850 Walnut Street, Philadelphia, PA 19107 66277 03/07/2006 PA Kansas City Cancer Center—Kansas, 12200 W. 110th Street, Overland Park, KS 66210 5650000D 03/07/2006 KS Kansas City Cancer Center—Missouri, 4881 Goodview Circle, Lee's Summit, MO 66064 5650000E 03/07/2006 MO Kreitchman PET Center, 180 Ft. Washington Avenue, HP3-315, New York, NY 10032 WEM661 03/07/2006 NY LakePointe PET, 10914 Hefner Pointe Drive, Suite 100, Oklahoma City, OK 73120 700522143 03/07/2006 OK Lakeshore PET Imaging, LLC, 4932 W 95th Street, Oak Lawn, IL 60453 200108 03/07/2006 IL Larchmont Imaging Associates, LLC, 210 Ark Road, Mt. Laurel, NJ 08054 517216 03/07/2006 NJ Las Cruces PET/CT Imaging, 1121 Mall Drive, Suite D, Las Cruces, NM 88011 300521065 03/07/2006 NM Lehigh Valley Diagnostic Imaging PET/CT, 1230 S. Cedar Crest Boulevard, Suite 104, Allentown, PA 18103 563802 03/07/2006 PA LifeScan Louisville, LLC, 4046 Dutchmans Lane, Louisville, KY 40207 9365601 03/07/2006 KY Limerick PET Associates, 420 W. Linfield-Trappe Road, Limerick, PA 19468 075015 03/07/2006 PA Suite 3400, Third Floor, Rear. LifeScan Minnesota, 6525 France Avenue S, Suite 225, Edina, MN 55435 470000014 03/07/2006 MN Louisiana PET Imaging of Alexandra, LLC, 5419 A Jackson Street Exit, Alexandria, LA 71303 5C743 03/07/2006 LA LMR PET, 12600 Creekside Lane, Ft. Meyers, FL 33919 E5725 03/07/2006 FL Louisiana PET Imaging of Lake Charles, LLC, 1750 Ryan Street, Lake Charles, LA 70601 5C905 03/07/2006 LA Insight Diagnostic Center—Forest Lane, 11617 N. Central Expressway, #132, Dallas, TX 75243 FTA016 03/07/2006 TX MDI of Thousand Oaks, 300 Lombard Street, Thousand Oaks, CA 91360 W14186 03/07/2006 CA Meadowbrook PET Associates, 1695 Huntington Pike, Meadowbrook, PA 19046 064866 03/08/2006 PA Medical Imaging of Baltimore, 6715 N. Charles Street, Baltimore, MD 21204 258L 03/08/2006 MD Metabolic Imaging of Laredo, 2344 Laguna Del Mar, Suites 5 & 6, Laredo, TX 78045 FTN029 03/08/2006 TX Methodist Hospital PET Imaging Center, 301 W. Huntington Drive, Suite 120, Arcadia, CA 91007 9511643336 03/08/2006 CA Metro Region PET Center at Chevy Chase, 5454 Wisconsin Avenue, Suite 810, Chevy Chase, MD 20815 724811 03/08/2006 MD Clinical PET of St. Charles County, 1475 Kisker Road, St. Charles, MO 63304 000047047 03/08/2006 MO Metro Region PET Center at Woodburn Nuclear Medicine, 3289 Woodburn Road, Annandale, VA 22003 724811 03/08/2006 VA Michiana Hematology-Oncology, PC, 100 Navarre Place, Suite 5550, South Bend, IN 46601 216950 03/08/2006 IN Michigan State University—Radiology, 184 Radiology Building, East Lansing, MI 48824 OC36350 03/08/2006 MI Clinical PET of West County, 450 N. New Ballas Road, Creve Coeur, MO 63141 000093043 03/08/2006 MO Modality Integration Services, Inc., 1854 SW Greenway Circle, West Linn, OR 97068 03/08/2006 OR Molecular Imaging Center, 1733 Curie Drive, Suite 305, El Paso, TX 79912 00315U 03/08/2006 TX Molecular Imaging of Suburban Chicago, LLC, 908 N. Elm Street, Suite 110, Hinsdale, IL 60521 212300 03/08/2006 IL Montclair Road Imaging LLC, 924 Montclair Road, Suite 108, Birmingham, AL 35213 000056277 03/08/2006 AL Montefiore Medical Center, 1695A Eastchester Road, Bronx, NY 10461 W06552 03/08/2006 NY Neurodiagnostics, PSC, 1725 Harrodsburg Road, Suite 100, Lexington, KY 40504 0406 03/08/2006 KY New Century Imaging, 555 Kinderkamack Road, Oradel, NJ 07649 085146 03/08/2006 NJ Newport Diagnostic Center, 1605 Avocado Avenue, Newport Beach, CA 92660 W13396 03/08/2006 CA Next Generation Radiology PET/CT, 560 Northern Boulevard, Suite 111, Great Neck, NY 11021 WR6091 03/08/2006 NY North Valley MRI and CT, 1638 Esplanade, Chico, CA 95926 ZZZ247802 03/08/2006 CA Northwest Alabama Cancer Center Radiology Services, 302 W. Dr. Hicks Boulevard, Florence, AL 35630 051552219 03/08/2006 AL Northern Kentucky PET Scan, LLC, 651 Centre View Boulevard, Crestview Hills, KY 41017 311754291 03/08/2006 KY Northwest Cancer Center, 17323 Red Oak Drive, Houston, TX 77090 00D29C 03/08/2006 TX Northwestern Memorial Hospital, 251 East Huron Street, Chicago, IL 60611 140281 03/08/2006 IL Galter 8-113. Northern Shared Medical Services—Atlantic, IA, 1501 East Tenth Street, Atlantic, IA 50022 I16068 03/08/2006 IA Cass County Memorial Hospital. Northern Shared Medical Services—Audubon, IA, 515 Pacific Street, Audubon, Iowa 50025 I16068 03/08/2006 IA Audobon County Memorial Hospital. Northern Shared Medical Services—Beloit, KS, 400 West Eighth, Beloit, KS 67420 130618 03/10/2006 KS Mitchell County Hospital. Northern Shared Medical Services—Bloomfield, IA, 507 North Madison Street, Bloomfield, IA 52537 I16068 03/10/2006 KS Davis County Hospital. Northern Shared Medical Services—Carrollton, MO, 1502 North Jefferson, Carrollton, MO 64633 000047013 03/10/2006 MO Carroll County Memorial Hospital. Northern Shared Medical Services—Centerville, IA, 1st St. Joseph Drive, Centerville, IA 52544 I16068 03/10/2006 IA Mercy Medical Center. Northern Shared Medical Services—Carthage, IL, 160 S. Adams Street, Carthage, IL 62321 208196 03/10/2006 IL Memorial Hospital. Northern Shared Medical Services—Clarinda, IA, 823 S. 17th Street, Clarinda, IA 51632 I16068 03/10/2006 IA Clarinda Regional Health Center. Northern Shared Medical Services—Chanute, KS, 629 South Plummer, Chanute, KS 66720 130618 03/10/2006 KS Neosho Memorial Regional Medical Center. Northern Shared Medical Services—Edwardsville, IL, 1121 University Drive, Edwardsville, IL 62025 208196 03/10/2006 IL Edwardsville Health Center. Northern Shared Medical Services—El Dorado, AR, 700 West Grove Street, El Dorado, AR 71730 5F168 03/10/2006 AR Medical Center of South Arkansas. Northern Shared Medical Services—Farmington, MO, 1212 Weber Road, Farmington, MO 63640 000047013 03/10/2006 MO Mineral Area Regional Medical Center. Northern Shared Medical Services—Janesville, WI, 1321 Creston Park Drive, Janesville, WI 53545 000092420 03/10/2006 WI Janesville Occupational Health & Medical Center. Northern Shared Medical Services—Hiawatha, KS, 300 Utah Street, Hiawatha, KS 66434 130618 03/10/2006 KS Hiawatha Community Hospital. Northern Shared Medical Services—Keokuk, IA, 1600 Morgan Street, Keokuk, IA 52632 I16068 03/10/2006 IA Keokuk Area Hospital. Northern Shared Medical Services—Macomb, IL, 525 East Grant Street, Macomb, IL 61455 208196 03/10/2006 IL McDonough District Hospital. Northern Shared Medical Services—Mexico, MO, 620 East Monroe Street, Mexico, MO 65265 000047013 03/10/2006 MO Audrain Medical Center. Northern Shared Medical Services—Moberly, MO, 1515 Union Avenue, Moberly, MO 65270 000047013 03/10/2006 MO Moberly Regional Medical Center. Northern Shared Medical Services—Mountain Home, AR, 899 Burnett Drive, Mountain Home, AR 72653 5F168 03/10/2006 AR Cogburn Cancer Clinic. Northern Shared Medical Services—Poplar Bluff, MO, 221 Physicians Park Drive, Poplar Bluff, MO 63901 000047013 03/10/2006 MO Poplar Bluff Medical Partners. Northern Shared Medical Services—Perryville, MO, 434 North West Street, Perryville, MO 63775 000047013 03/10/2006 MO Perry County Memorial Hospital. Northern Shared Medical Services—Rolla, MO, 1000 West Tenth Street, Rolla, MO 65401 000047013 03/10/2006 MO Phelps Co Regional Medical Center. Northern Shared Medical Services—Virginia, MN, 901 Ninth Street North, Virginia, MN 55792 470000057 03/10/2006 MN Virginia Regional Medical Center. Northern Shared Medical Services—Russellville, AR, 2504 West Main Street, Russellville, AR 72801 5F168 03/10/2006 AR Russellville Land Co. Northern Shared Medical Services—West Plains, MO, 1100 Kentucky Avenue, West Plains, MO 65775 000047013 03/10/2006 MO Ozarks Medical Center. Oakwood Hospital Medical Center, 18101 Oakwood Boulevard, Dearborn, MI 48124 230020 03/10/2006 MI Oakwood Southshore Medical Center, 5450 Fort Street, Trenton, MI 48183 230176 03/10/2006 MI Ocean Medical Imaging Center, 21 Stockton Drive, Toms River, NJ 08755 158432 03/10/2006 NJ Orange County Regional PET Center, LLC, 16300 Sand Canyon Avenue, Suite 103, Irvine, CA 92618 TP018 03/10/2006 CA Orange Advanced Imaging Center, 230 Main Street, #101, Orange, CA 92868 TP016A 03/10/2006 CA Pacific Coast Imaging—Irvine, 250 E Yale Loop, Suite A, Irvine, CA 92604 WG87478B 03/10/2006 CA Pacific Coast Imaging—Newport, 3300 West Coast Highway, Newport Beach, CA 92663 WG87478 03/10/2006 CA Pacific Imaging and Treatment Center, 5395 Ruffin Road, Suite 202, San Diego, CA 92123 TP126 03/10/2006 CA Palm Beach Cancer Institute, 1395 State Road 7, Suite 310, Wellington, FL 33414 34754 03/10/2006 FL Pennsylvania PET Associates, 800 Spruce Street, Philadelphia, PA 19107 066282 03/10/2006 PA Second Floor, Widener Building. PET Center of Western NY, 127 North Street, Batavia, NY 14020 187140 03/10/2006 NY Pet Imaging at CDR, 7600 N 15th Street, Suite 102, Phoenix, AZ 85020 WCFDG 03/10/2006 AZ PET Imaging at the Lake, 5000 Hennessy Boulevard, Baton Rouge, LA 70809 5C868 03/10/2006 LA PET Imaging Center at Harford County, 602 S Atwood Road, Suite 201, Bel Air, MD 21014 FMN006 03/10/2006 MD PET Imaging Institute of South Florida—East, 150 N 35th Avenue, 665, Hollywood, FL 33021 E3783 03/10/2006 FL PET Imaging Institute of South Florida—West, 603 N Flamingo Road, S-155, Pembroke Pines, FL 33028 E3783 03/10/2006 FL PET Scan Arizona—Peoria, 13460 N 94th Drive, Suite J1, Peoria, AZ 85381 75400 03/10/2006 AZ PET Scan Arizona—Phoenix, 6036 N 19th Avenue, Suite 305, Phoenix, AZ 85015 66860 03/10/2006 AZ PET/CT Diagnostic Medical Imaging, PC, 1200 Waters Place, Suite M108, Bronx, NY 10461 W31091 03/10/2006 NY Precision Imaging, 4416 East West Highway, Suite 410, Bethesda, MD 20814 FMN005 03/10/2006 MD Preferred PET Imaging of Kansas, LLC, 928 N. St. Francis Street, Wichita, KS 67214 110693 03/10/2006 KS Premium Diagnostics Center, 5319 Hoag Drive, Suite 130, Elyria, OH 44035 ID01851 03/10/2006 OH PET Center Ft. Worth, 800 W. Magnolia Avenue, Fort Worth, TX 76104 0J062 03/10/2006 TX Suite 100. Radiology Associates, LLP, 6001 S. Staples Street, Corpus Christi, TX 78413 00E816 03/10/2006 TX S. Arlington Imaging Center, 4601 Matlock Road, Arlington, TX 76018 0J062 03/10/2006 TX Radiology Group Imaging Center, LLC, 1970 E. 53rd Street, Davenport, IA 52807 16031 03/10/2006 IA PET/CT Scan Center Pembroke, 11325 Pembroke Square, Suite 116, Waldorf, MD 20603 521454775 03/10/2006 MD New York MedScan, 751 Second Avenue, New York, NY 10017 978701 03/10/2006 NY Rex Healthcare, 4420 Lake Boone Trail, Raleigh, NC 27607 340114 03/10/2006 NC San Fernando Regional PET Center, 6855 Noble Avenue, Van Nuys, CA 91405 TP078 03/10/2006 CA PET/CT Imaging Center of Northwest Florida, 5149 North 9th Avenue, Suite 124, Pensacola, FL 32504 U4696 03/10/2006 FL Saint Joseph's Hospital—Nuclear Medicine, 611 St. Joseph Avenue, Marshfield, WI 54449 520037 03/10/2006 WI Shared PET Imaging, LLC—Brooklyn NY, 6300 Eight Avenue, Brooklyn, NY 11220 97Z661 03/10/2006 NY SC Cancer Specialists, 25 Hospital Center Boulevard #301, Hilton Head Island, SC 29926 1285633289 03/10/2006 SC Shared PET Imaging, LLC—Granger IN, 6901 N. Main Street, Granger, IN 46530 232800 03/10/2006 IN University Hospital—Cincinnati, Eden Avenue & Albert Sabin Way, Cincinnati, OH 45219 03/10/2006 OH Shared PET Imaging, LLC—Marion OH, 1050 Delaware Avenue, Marion, OH 43302 ID01511 03/10/2006 OH Shared PET Imaging, LLC—Terre Haute IN, 3702 South Fourth Street, Terre Haute, IN 47802 201320 03/10/2006 IN South Jersey Radiology Associates, PA, 100 Carnie Boulevard, Suite B5, Voorhees, NJ 08043 S0429966 03/10/2006 NJ Southwest PET/CT Institute—Tucson, 3503 N. Campbell, Suite 155, Tucson, AZ 85719 1396736922 03/10/2006 AZ Southwest PET/CT Institute—Yuma, 1951 W. 25th Street, Suite G, Yuma, AZ 85364 106077 03/10/2006 AZ St. Francis Health Center, 1700 SW 7th Street, Topeka, KS 66606 17-0016 03/10/2006 KS Southwoods PET Scan, LLC, 250 Debartolo Place, Building B, Youngstown, OH 44512 PCN05210036 03/10/2006 OH St. Louis PET Centers, LLC, 12637 Olive Boulevard, Creve Coeur, MO 63376 1861470734 03/10/2006 MO St. Vincent's PET Center, LLC, 2660 10th Avenue S, POBI, Suite 104, Birmingham, AL 35205 051555054 03/10/2006 AL Sun Molecular Imaging—Peoria, 13090 N. 94th Drive, #103, Peoria, AZ 85381 71585 03/10/2006 AZ Sun Molecular Imaging—Sun City West, 13909 W Camino Del Sol, #101, Sun City West, AZ 85375 71585 03/10/2006 AZ Tarzana Advanced Imaging, 5536 Reseda Boulevard, Tarzana, CA 91356 TP051A 03/10/2006 CA The Methodist Hospital PET Center, 6565 Fannin Street, MBI-066, Houston, TX 77030 450358 03/10/2006 TX Texarkana PET Imaging Institute, LP, 1929 Moores Lane, Texarkana, TX 75503 FTN008 03/10/2006 TX The PET/CT Center of North Florida, 5742 Booth Road, Jacksonville, FL 32207 K7038P 03/10/2006 FL The Washington Hospital, 155 Wilson Ave, Washington, PA 15301 390042 03/10/2006 PA The PET/CT Scanning Center, 235 18th Street, SE, Hickory, NC 28602 2881788 03/10/2006 NC Thompson Cancer Survival Center PET Imaging Center, 9711 Sherrill Boulevard, Knoxville, TN 37923 3791106 03/10/2006 TN Thunderbird MRI and PET Center, 6591 W. Thunderbird Road, Suite A-1, Glendale, AZ 85306 79467 03/10/2006 AZ Tower Imaging Roxsan, 465 N. Roxbury Drive, Suite 101, Beverly Hills, CA 90210 TP114 03/10/2006 CA Tower Hematology Oncology Medical Group, 9090 Wilshire Boulevard, Suite 200, Beverly Hills, CA 90211 W11793 03/10/2006 CA TRA Medical Imaging, 2202 S Cedar, Suite 200, Tacoma, WA 98405 001055600 03/10/2006 WA Trident PET of Fayette, 1275 Highway 54 West, Suite 102, Fayetteville, GA 30214 47BBBJJ 03/10/2006 GA Trident PET of Gwinnett, 545 Old Norcross Road, Lawrenceville, GA 30045 47BBBGX 03/10/2006 GA Suite 200. Trident PET of Savannah, 7135 Hodgson Memorial Drive, Savannah, GA 31406 47BBBKP 03/10/2006 GA Suite 10A. Tristan Associates, 4520 Union Deposit Road, Harrisburg, PA 17111 112344 03/10/2006 PA Union Square Diagnostic Imaging, 144 Fourth Avenue, New York, NY 10003 WR7502 03/10/2006 NY UCLA—Dept. of Molecular & Medical Pharmacology, 10833 Le Conte Avenue, Los Angeles, CA 90095 HW13029 03/10/2006 CA AR-115-CHS. UCLA—Dept. of Molecular & Medical Pharmacology, 10833 Le Conte Avenue, Los Angeles, CA 90095 HW13029 03/10/2006 CA AR-115-CHS. University Nuclear Medicine, Inc., 105 Parker Hall, Buffalo, NY 14214 14414A 03/10/2006 NY 3435 Main St. University Radiology Group, 75 Veronica Avenue, Suite 102, Somerset, NJ 08873 425699 03/10/2006 NJ Anne Arundel Medical Center, 2001 Medical Parkway, Annapolis, MD 21401 210023 03/10/2006 MD US Imaging Center Corp., LLC, 842 Sunset Lake Boulevard, Suite 301, Venice, FL 34292 U0331 03/10/2006 FL USC PET Imaging Science Center, 1510 San Pablo Street, Suite 350, Los Angeles, CA 90033 W11874 03/10/2006 CA Rolling Oaks Radiology, 415 Rolling Oak Drive, Suite 160, Thousand Oaks, CA 91361 W10746 03/10/2006 CA Vero Radiology Associates, Inc., 777 37th Street, Suite A-103, Vero Beach, FL 32960 97445 03/10/2006 FL Ventura Coast Imaging Center, 4601 Telephone Road, Suite 101, Ventura, CA 93003 W11335 03/10/2006 CA Washington Imaging Services, LLC, 1135-116th Avenue, NE, Bellevue, WA 98004 GAB23386 03/10/2006 WA Washington Hospital Center, 110 Irving Street, NW, Washington, DC 20010 090011 03/10/2006 DC Washoe Med Imaging Services at 75 Kirman, 75 Kirman Avenue, Reno, NV 89502 WCHBB 03/10/2006 NV Wesley Long Hospital—Moses Cone Health System, 501 North Elam Avenue, Greensboro, NC 27403 34-0091 03/10/2006 NC Westcoast Radiology, 36463 US Highway, 19 N., Palm Harbor, FL 34684 E4187 03/10/2006 FL Western Washington Oncology, 4525 3rd Avenue SE, Lacey, WA 98503 1497749642 03/10/2006 WA Windber Medical Center, 600 Somerset Avenue, Windber, PA 15963 390112 03/10/2006 PA Wyoming Valley PET Associates, 190 Welles Street, Forty Fort, PA 18704 045012 03/10/2006 PA Youngstown Regional PET Scan, 850 McKay Court, Youngstown, OH 44512 Y0ID0174 03/10/2006 OH X-RAY Associates at Santa Fe, 490 A West Zia Road, Suite 130, Santa Fe, NM 87505 2258263 03/10/2006 NM Sibley Memorial Hospital, 5255 Loughboro Road, NW, Washington, DC 20016 090005 03/10/2006 DC Lerman Diagnostic Imaging, 6511 Fort Hamilton Parkway, Brooklyn, NY 11215 16H771 03/10/2006 NY XRC Medical Imaging, 53940 Carmichael Drive, South Bend, IN 46635 187390 03/10/2006 IN St. Luke's Hospital, 1026 A. Avenue N.E., Cedar Rapids, IA 52406-3026 160045 03/10/2006 IA P.O. Box 3026. University Imaging at Science Park, 110 Science Parkway, Suite 100, Rochester, NY 14620 16624A 03/10/2006 NY Kadlec Medical Center/Nuclear Medicine Dept., 945 Goethals Street, Richland, WA 99352 1972507580 03/10/2006 WA Central Georgia PET, LLC, 1650 Hardmon, Macon, GA 31201 47BBBKC 03/10/2006 GA PET/CT Imaging at Swedish Cancer Institute, 1221 Madison Street, First Floor, Seattle, WA 98104 8857387 03/10/2006 WA National PET Scan Duval, LLC, 425 North Lee Street, Jacksonville, FL 32204 E7348 03/10/2006 FL National PET Scan Pinellas, LLC, 805 Executive Center Drive W, St. Petersburg, FL 33702 E7503 03/10/2006 FL National PET Scan Dade, LLC, 7867 North Kendall Drive, Suite 121, Miami, FL 33156 E5427 03/10/2006 FL National PET Scan Broward, LLC, 6290 North Federal Highway, Fort Lauderdale, FL 33308 E5432 03/10/2006 FL Scottsdale Medical Imaging, Ltd., 7624 E. Indian School Road, Suite 109-1, Scottsdale, AZ 85251 WCFKX 03/10/2006 AZ Lakes Regional General Hospital, 80 Highland Street, Laconia, NH 03246 300005 03/10/2006 NH Northern California PET Imaging Center, 3195 Folsom Boulevard, Sacramento, CA 95816 ZZZ15725Z 03/10/2006 CA Northern California PET Imaging Center—Mobile, 3195 Folsom Boulevard, Sacramento, CA 95816 ZZZ25157Z 03/10/2006 CA Northern California PET Imaging Center—VAPA, 3801 Miranda Avenue, Palo Alto, CA 94304 ZZZ21308Z 03/10/2006 CA Advanced Medical Imaging, 3548 Route 9 South, Old Bridge, NJ 08857 595865 03/10/2006 NJ St. Vincent Infirmary Medical Center, PET/CT Center, 2 St. Vincent Circle, Little Rock, AR 72205-5499 04-0007 03/10/2006 AR Lincoln Trail Diagnostics, 1111 Woodland Drive, Elizabethtown, KY 42701 470001408 03/10/2006 KY LifeScan Imaging, 607 Clifty Street, Somerset, KY 42503 7614 03/10/2006 KY St. John's Hospital Springfield Nuclear Medicine, 1235 E. Cherokee Street, Springfield, MO 65804 26-0065 03/10/2006 MO City of Hope, 1500 E. Duarte Road, Duarte, CA 91010 050146 03/10/2006 CA Dept. of Nuclear Medicine. Hackettstown Regional Medical Center, 651 Willow Grove Street, Hackettstown, NJ 07840 310115 03/10/2006 NJ Imaging Alliance—Nashville PET, LLC, 52 White Bridge Road, Nashville, TN 37205 3791068 03/10/2006 TN Molecular Imaging of Bradenton, 2301 60th Street, Court West, Suite A, Bradenton, FL 34209 U1334 03/10/2006 FL Molecular Imaging of Charlotte County, 4130 Tamiami Trail, Port Charlotte, FL 33952 U1934 03/10/2006 FL Imaging For Life, 3830 Bee Ridge Road, Suite A, Sarasota, FL 34233 E6704 03/10/2006 FL Seattle Nuclear Medicine/Ultrasound Associates, 1229 Madison Street, Suite 1050, Seattle, WA 98104 G000158400 03/10/2006 WA Columbus Circle Imaging, 1790 Broadway, 9th Floor, Yonkers, NY10704 W00691 03/10/2006 NY Bryn Mawr Imaging Center—PET, 100 Lancaster Avenue, Wynnewood, PA 19096 473120 03/10/2006 PA Beth Israel Deaconess Medical Center, 330 Brookline Avenue, Boston, MA 02215 220086 03/10/2006 MA Boca Raton Community Hospital, 800 Meadows Road, Boca Raton, FL 33486 100168 03/10/2006 FL Centro Tomograficio de PR, Inc., 1409 Ashford Avenue, San Juan, PR 00907 0087834 03/10/2006 PR Comprehensive Cancer Centers of Nevada, 3730 S. Easton, Las Vegas, NV 89109 WCHCX 03/10/2006 NV Grossman Imaging Center of CMH, 2151 E. Gonzales Road, Suite 101, Oxnard, CA 93036 W17252 03/10/2006 CA Cookeville Regional Medical Center, 142 W. 5th Street, Cookeville, TN 38501 440059 03/10/2006 TN Instituto Central de Diagnostico, Inc.,1er. Floor Oncologic Hospital, San Juan, PR 00928 007835 03/10/2006 PR PR Medical Center. Mercy Medical Center—Cedar Rapids, 701 Tenth Street SE, Cedar Rapids, IA 52403 16-0079 03/10/2006 IA Midwest Radiologic Imaging—1144217241, 4087 Gateway Boulevard, Newburgh, IN 47630 1144217241 03/10/2006 IN Miami Valley Hospital, 1 Wyoming Street, Dayton, OH 45409 360051 03/10/2006 OH Midwest Radiologic Imaging—214790, 4087 Gateway Boulevard, Newburgh, IN 47630 214790 03/10/2006 IN Midwest Regional PET/CT Center, 6001 S. Sharon Avenue, Suite #2, Sioux Falls, SD 57108 41406 03/10/2006 SD Mission Hospital, PET Center, 222 Asheland Avenue, Asheville, NC 28801 3400002 03/10/2006 NC Mobile Molecular Imaging, LLC, 100 Memorial Hospital Drive, Suite 1E, Mobile, AL 36608 1003804345 03/10/2006 AL Nebraska Health Imaging, 7819 Dodge Street, Omaha, NE 68114 098975 03/13/2006 NE Montgomery Metabolic & Memory Imaging Center, 7100 University Ct., Montgomery, AL 36117 057554625 03/13/2006 AL Orange County Diagnostic Radiology, Inc., 17150 Euclid Street, Suite 101, Fountain Valley, CA 92708 TD057 03/13/2006 CA Northwest PET Imaging, 265 N. Broadway, Portland, OR 97227 105512 03/13/2006 OR Nevada Cancer Institute Medical Group, One Breakthrough Way, 10441 W. Twain Avenue, Las Vegas, NV 89135 100505 03/13/2006 NV Positron Emission Tomography Institute at Hampton, 5357 Henneman Drive, Norfolk, VA 23513 FVN001 03/13/2006 VA Positron Imaging Facility, 1311 Record Crossing Road, Mail Code 9140 Dallas, TX 75235 UT000F626 03/13/2006 TX Premier Diagnostic Imaging, 10019 Forest Green Boulevard, Louisville, KY 40299 9375201 03/13/2006 KY Positron PET/CT of the Southern Tier, 169 Riverside Drive, Binghamton, NY 13905 AA1047 03/13/2006 NY Radiology Regional Center, PA, Inc.—Naples, 700 Goodlette Road, Naples, FL 34102 77185 03/13/2006 FL Somascan Plaza, Inc., Suite 405 Torre de Plaza Plaza Las Americas, San Juan, PR 00917 0089178 03/13/2006 PR Somascan, Inc., Jose Marti #56, San Juan, PR 00917 0082435 03/13/2006 PR Southern Indiana Radiological Associates, 500 Landmark Avenue, Bloomington, IN 47403 214160 03/13/2006 IN Southern Illinois Cancer Center, 10286 Fleming Road, Carterville, IL 62918 643740 03/13/2006 IL South Nassau PET, One Healthy Way, Oceanside, NY 11572 97z851 03/13/2003 NY Southwest Diagnostic Center for Molecular Imaging, 8440 Walnut Hill Lane, Suite 100, Dallas, TX 75231 FTN-015 03/13/2006 TX St. Mary's Health Systems, 900 E. Oakhill Avenue, Knoxville, TN 37917 440120 03/13/2006 TN Tower Diagnostic Center, 4719 N. Habana Avenue, Tampa, FL 33614 00169 03/13/2003 FL Torrance Morial Medical Center, 3330 Lomita Boulevard, Torrance, CA 90505 050351 03/13/2006 CA University of Colorado Hospital (AOP), 1635 N. Ursula Street, Aurora, CO 80045 06-0024 03/13/2006 CO William Beaumont Hospital—Royal Oak, 3601 West 13 Mile Road, Royal Oak, MI 48073-6769 23030 03/13/2006 MI Esther Quijoy Catalya, M.D., 3000 Oak Road #111, Walnut Creek, CA 94597 00A449120 03/13/2006 CA Valley PET Institute, 311 S. Ham Lane, Lodi, CA 95242 00C283720 03/13/2006 CA Dan Ben-Zeev, M.D., 3000 Oak Road #111, Walnut Creek, CA 94597 00G129831 03/13/2006 CA Midwest Center for Advanced Imaging, 1307 Macom Drive, Naperville, IL 60564 L72461 03/13/2006 IL Crittenton Hospital Medical Center, 1101 W. University Drive, Rochester, MI 48307 230054 03/13/2006 MI Medical Specialists of Palm Beaches, Inc., 5700 Lake Worth Road, Suite 204, Lake Worth, FL 33463 33941A 03/13/2006 FL PET Medical Imaging Center, 3264 North Evergreen Drive, Grand Rapids, MI 49525 0P02650 03/13/2006 MI Radiology Regional Center, PA, Inc.—RPET, 6100 Winkler Road, Suite A, Fort Myers, FL 33919 77185 03/13/2006 FL Good Samaritan Hospital, 520 S. 7th Street, Vincennes, IN 47591 150042 03/13/2006 IN Central Indiana Cancer Center, 6845 Rama Drive, Indianapolis, IN 46219 065910 03/13/2006 IN Decatur PET Imaging, 2774 W. Decatur Road, Decatur, GA 30033 47BBBLP 03/13/2006 GA Community Memorial Hospital, Medical Imaging, 855 S. Main Street, Oconto Falls, WI 54154 00439MPN 03/13/2006 WI Olympic Radiology, 2700 Clare Avenue, Bremerton, WA 98310 000242100 03/13/2006 WA Capitol Imaging, 3161 L Street, Sacramento, CA 95816 1285615294 03/13/2006 CA National Medical Imaging—Bryn Mawr, 574 W. Lancaster Avenue, Bryn Mawr, PA 19010 024513 03/13/2006 PA National Medical Imaging—Langhorne, 2 Doublewoods Road, Suite B Langhorne, PA 19047 024513 03/13/2006 PA National Medical Imaging—Philadelphia, 1903-05 South Broad Street, Philadelphia, PA 19148 024513 03/13/2006 PA University of VA Health System, Radiology, 1215 Lee Street, Charlottesville, VA 22908 490009 03/13/2006 VA Florida Institute for Advanced Diagnostic Imaging, 9238 US 19, Port Richey, FL 34668 59-3475930 03/13/2006 FL Roseville PET & Nuclear Medicine Imaging, 2241 Douglas Boulevard #110, Roseville, CA 95661 1194706689 03/13/2006 CA Memorial Sloan Kettering Cancer Center, 1275 York Avenue, New York, NY 10021 330154 03/13/2006 NY Northeast PET Imaging Center, 8400 Roosevelt Boulevard, Suite 208 Philadelphia, PA 19152 083723 03/13/2006 PA Medical Arts Center at Parte Ridge. UAMS PET Center, 4301 West Markham Street Little Rock, AR 72205 50528 03/13/2006 AR Joliet Oncology-Hematology Assoc., Ltd., 1600 W. Route 6, Morris, IL 60450 205474 03/13/2006 IL Saint Luke's Hospital, 4323 Wornall Road, Kansas City, MO 64111 26-0138 03/13/2006 MO AH Peet Center. Mercy Medical Center, 1320 Mercy Drive, Canton, OH 44708 360070 03/13/2006 OH Dayton Medical Imaging Center, 7901 Schatz Pointe Drive, Dayton, OH 45459 US1D00231 03/13/2006 OH Community Radiology of Virginia, 2000 Leatherwood Lane, Bluefield, VA 24605 FVA002 03/13/2006 VA Bab Radiology—Huntington, 75 East Main Street, Huntington, NY 11743 W1L612 03/13/2006 NY Bab Radiology—Hauppauge, 521 Route 111, Suite 312, Hauppauge, NY 11788 W1L601 03/13/2006 NY Center for Diagnostic Imaging-37, 5775 Wayzata Boulevard #190, St. Louis Park, MN 55416 470000037 03/13/2006 MN Center for Diagnostic Imaging, 5775 Wayzata Boulevard, Suite 190, St. Louis Park, MN 55416 C01307 03/13/2006 MN Center for Diagnostic Imaging—Mendota Heights, 910 Sibley Memorial Highway, Mendota Heights, MN 55118 470000038 03/13/2006 MN Huntsville Hospital Imaging Center, 1963 Memorial Parkway, Huntsville, AL 35801 010039 03/13/2006 AL Long Beach PET Imaging Center, 2888 Long Beach Boulevard, Suite 110, Long Beach, CA 90806 TG167 03/13/2006 CA Highway Imaging Associates, LLP, 2095 Flatbush Avenue, Brooklyn, NY 11234 W10671 03/13/2006 NY St. Vincent Hospital, PO Box 13508, Green Bay, WI 54307 520075 03/13/2006 WI Park South Imaging Center, 6215 21st Avenue, West #A, Bradenton, FL 34209 E1858 03/13/2006 FL Mary Bird Perkins Cancer Center, 4950 Essen Lane, Baton Rouge, LA 70809 57290 03/13/2006 LA Boston Diagnostic Imaging, 398 Altamonte Drive, Altamonte Springs, FL 32701 E3510 03/13/2006 FL Sioux Valley Hospital Medical Center, 1305 W. 18th Street, Sioux Falls, SD 57117 430027 03/13/2000 SD Indianapolis Regional PET Scan, LLC, 3830 Shore Drive, Indianapolis, IN 46254 207260 03/13/2006 IN St. Joseph's PET Center, 1 Mercy Lane, Suite 105, Hot Springs, AR 71913 5C739 03/13/2006 AR Hinsdale PET Scan, LLC, 812 Ogden Avenue, Westmont, IL 60559 206271 03/13/2006 IL Del Amo PET Imaging Center, 3531 Fashion Way, Torrance, CA 90501 TP120 03/13/2006 CA North Shore PET Imaging Center, 85 Herrick Street, Beverly, MA 1915 327110 03/13/2006 MA Beverly Hospital. Robert D. Russo & Associates Radiology, PC, PO Box 6128, Bridgeport, CT 06606 C02013 03/13/2006 CT Advanced Medical Specialties, 9035 Sunset Drive, Suite 102, Miami, FL 33173 K7806 05/03/2006 FL Baptist M & S Imaging Center—Downtown, 215 E. Quincy Street #100, San Antonio, TX 78215 FTA078 05/03/2006 TX Community Cancer Center, 545 W. Umpqua Street, Roseburg, OR 97470 R116571 05/03/2006 OR Baptist M & S Imaging Center, 7888 Fredericksburg Road, San Antonio, TX 78228 FTA078 05/03/2006 TX Evanston Northwestern Healthcare—Highland Park, 757 Park Avenue West, Highland Park, IL 60035 14-0010 05/03/2006 IL Grenada Diagnostic Radiology, 1300 Sunset Drive, Suite U, Grenada, MS 38901 470000034 05/03/2006 MS Huntsman Cancer Hospital, 2000 Circle of Hope, Suite 2121, Salt Lake City, UT 84112-5550 460009 05/03/2006 UT High Tech Medical Park, 11800 Southwest Highway, Palos Heights, IL 60463 0703070 05/03/2006 IL Cyrus Diagnostic Imaging, Inc., 165 Waymont Court, Lake Mary, FL 32746 40586 05/03/2006 FL Indiana Regional PET Imaging, 7891 Broadway, Suite A, Merrillville, IN 46410 229400 05/03/2006 IN Lancaster PET Imaging, 2100 Harrisburg Pike, Lancaster, PA 17601 054504 05/03/2006 PA James PET/CT Imaging Center, 236 Doan Hall, Columbus, OH 43210 360242 05/03/2006 OH 410 W. 10th Ave. Mary Lanning Memorial Hospital, 715 N. St. Joseph Avenue, Hastings, NE 68901 280032 05/03/2006 NE Maplewood Cancer Center—MOHPA, 1580 Beam Avenue, Maplewood, MN 55109 C01828 05/03/2006 MN Titusville Area Hospital, 406 W. Oak Street, Titusville, PA 16354 390122 05/03/2006 PA Memorial Hospital, 325 S. Belmont Street, York, PA 17403 390101 05/03/2006 PA Mercy Regional Health Center, 1823 College Avenue, Manhattan, KS 66502 17-0142 05/03/2006 KS Northshore Regional PET Scan, LLC, 1464 Waukegan Road, Glenview, IL 60025 206272 05/03/2006 IL Northwest Indiana PET/CT Center, 1505 S. Calument Road, Suites 7 & 8, Chesterton, IN 46304 229810 05/03/2006 AL Parkway Ventures, Inc., 9000 Franklin Square Drive, Baltimore, MD 21237 FMN002 05/03/2006 MD Franklin Square Hospital. PET Fusion Imaging, 3707 New Vision Drive, Fort Wayne, IN 46845 190320 05/03/2006 IN River Oaks Imaging & Diagnostics, PO Box 4346, Houston, TX 77210 FTA059 05/03/2006 TX Dept 848. Regional PET Scan, LLC—Beachwood, 2000 Auburn Road, Beachwood, OH 44122 REID02211 05/03/2006 OH Regional PET Scan, LLC—Fairview, 20455 Lorain Road, Fairview Park, OH 44126 REID02211 05/03/2006 OH Regional PET Scan, LLC—Ridgepark, 7575 Northcliff Avenue, Brooklyn, OH 44144 REID02211 05/03/2006 OH Saint Francis Hospital, 114 Woodland Street, Hartford, CT 06105 07-0002 05/03/2006 CT St Nicholas Hospital, 3100 Superior Avenue, Sheboygan, WI 53081 520044 05/03/2006 WI Swedish Medical Center, 501 E. Hampton Avenue, Englewood, CO 80113 060034 05/03/2006 CO St Bernards PET Center, 225 E. Jackson Avenue, Jonesboro, AR 72401 5C658 05/03/2006 AR Toledo Regional PET Scan, LLC, 3442 Granite Circle, Toledo, OH 43617 T0ID01881 05/03/2006 OH University MRI, 3848 F.A.U. Boulevard, Suite 200, Boca Raton, FL 33431 E1765 05/03/2006 FL Tucson PET Imaging, 5355 E. Erickson Drive, Tucson, AZ 85712 WCBBM 05/03/2006 AZ Via Christi Oklahoma Regional Medical Center, 1900 N. 14th Street, Ponca City, OK 74601 370006 05/03/2006 OK Christian Hospital, 11133 Dunn Road, St Louis, MO 63136 260180 05/03/2006 MO DRA Imaging PC, 1 Columbia Street, Poughkeepsie, NY 12601 W18691 05/03/2006 NY Cleveland Clinic Star Imaging, 921 Jasonway Avenue, Columbus, OH 43214 34-1932969 05/03/2006 OH Norman PET Associates, LLC, 3750 W. Robinson Street, Suite 130, Norman, OK 73072 900522224 05/03/2006 OK Rhode Island PET Services—St. Josephs, 200 High Service Avenue, N Providence, RI 02904 479003556 05/03/2006 RI Rhode Island PET Services—South County Hospital, 100 Kenyon Avenue, Wakefield, RI 02879 479003556 05/03/2006 RI Rhode Island PET Services—Roger Williams, 825 Chalkstone Avenue, Providence, RI 02908 479003556 05/03/2006 RI Rhode Island PET Services—Landmark, 115 Cass Avenue, Woonsocket, RI 02895 479003556 05/03/2006 RI Forest City Diagnostic Imaging, 735 Perryville Road, Rockford, IL 61107 546450 05/03/2006 IL Lower Level 2. New England Molecular Imaging—York, 15 Hospital Drive, York, ME 03909 479003556 05/03/2006 ME Pavilion Imaging, 750 Wellington Avenue, Grand Junction, CO 81502 060023 05/03/2006 CO Lifescan Chicago, 2242 W. Harrison Street, Chicago, IL 600612 470000014 05/03/2006 IL Southeast Medical Imaging, 300 Evergreen Drive, Suite 210, Glen Mills, PA 19342 092801 05/03/2006 PA The Western Pennsylvania Hospital, 4800 Friendship Avenue, Pittsburgh, PA 15224 390090 05/03/2006 PA Southtowns PET/CT, 550 Orchard Park Road, West Seneca, NY 14224 14422A 05/03/2006 NY Main Street Radiology—Bayside, 44-01 Francis Lewis Boulevard, Bayside, NY 11361 04217 05/03/2006 NY Main Street Radiology—Bayside, 44-01 Francis Lewis Boulevard, Bayside, NY 11361 04217A 05/03/2006 NY West VA University Center for Advanced Imaging, 1 Medical Center Drive, Morgantown, WV 26506 9121131 05/03/2006 WV PO Box 9236, Health Center South. Twin Lakes Medical Specialist, PA, 228 Bucher Drive, Mountain Home, AR 72653 5B019 05/03/2006 AR Valley Metabolic Imaging, LLC, 6121 N Thesta Street, Fresno, CA 93710 ZZZ23924Z 05/03/2006 CA Suite 207. Johnson City Medical Center, 400 North State of Franklin, Johnson City, TN 37642 440063 05/03/2006 TN St Louis University Hospital, 3665 Vista Avenue, St Louis, MO 63110 000050109 05/03/2006 MO Margaret R. Pardee Memorial Hospital, 800 North Justice Street, Hendersonville, NC 28791 340017A 05/03/2006 NC Valley Imaging Partnership 1401 W. Merced Avenue #103, West Covina, CA 91790 TP035 05/03/2006 CA Sierra Imaging, 155 Calle Portal, Sierra Vista, AZ 85635 Z68496 05/03/2006 AZ Aspirus Wausau Hospital, 333 Pine Ridge Boulevard, Wausau, WI 54401 520030A 05/03/2006 WI Cancer Care Northwest PET Center, 910 W 5th, Spokane, WA 99204 1922072081 05/03/2006 WA Suite 130. PET/CT Imaging of North Texas, 2900 North I-35, Denton, TX 76201 00088Y 05/03/2006 TX Suite 119. Loyola University Health System, 2160 S. First Avenue, Maywood, IL 60153 140276 05/03/2006 IL St. Elizabeth Medical Center, One Medical Village Drive, Edgewood, KY 41017 180035 05/03/2006 KY Cleveland Clinic, 9500 Euclid Ave, Cleveland, OH 44195 9925511 05/03/2006 OH Ingalls Family Care Center, 6701 159th Street, Tinley Park, IL 60477 14-0191 05/03/2006 IL PET Fusion Center, 4204 Houma Boulevard, Metairie, LA 70006 5CB31 05/03/2006 LA United Regional Medical Center, 1001 McArthur Drive, Manchester, TN 37355 440007 05/03/2006 TN Joel Bernstein, MD, 5395 Ruffin Road, Suite 202, San Diego, CA 92123 W18972 05/03/2006 CA Hasnat Ahmed, MD, 5395 Ruffin Road, Suite 202, San Diego, CA 92123 W18370 05/03/2006 CA Meridian North Imaging Center, 12188 N. Meridian Street, Carmel, IN 46280 026010 05/03/2006 IN Suite 100. Cancer Center Oncology Medical Group, 5395 Ruffin Road, Suite 202, San Diego, CA 92123 W12245A 05/06/2006 CA Firelands Regional Medical Center, 1101 Decatur Street, Sandusky, OH 44870 360025 05/03/2006 OH United Radiology—Greenbelt, PO Box 34979, West Bethesda, MD 20827 FMN007 05/03/2006 MD Richard Just, MD, 5395 Ruffin Road, Suite 202, San Diego, CA 92123 W16197 05/03/2006 CA Michael Kipper, MD, 5395 Ruffin Road, Suite 202, San Diego, CA 92123 A24091 05/03/2006 CA McLaren Regional Medical Center, 401 S. Ballenger Highway, Flint, MI 48532 230141 05/03/2006 MI United Radiology—Silver Spring, PO Box 34979, West Bethesda, MD 20827 FMN007 05/03/2006 MD United Radiology—Rockville, PO Box 34979, West Bethesda, MD 20827 FMN007 05/03/2006 MD St Mary's Health Center, 6420 Clayton Road, St Louis, MO 63117 260091 05/03/2006 MO Bay Regional Medical Center, 1900 Columbus Avenue, Bay City, MI 48708 230041 05/03/2006 MI Lapeer Regional Medical Center, 1375 N. Main Street, Lapeer, MI 48446 230193 05/03/2006 MI Scottsdale Medical Imaging, Ltd.—SW Diagnostics, 9003 E. Shea Boulevard, Scottsdale, AZ 85260 1902896236 05/03/2006 AZ Valley Medical Oncology Consultants, Inc., 3000 Oak Road #111, Walnut Creek, CA 94597 ZZZ29659Z 05/03/2006 CA Northwest Community Hospital, 800 W Central Road, Arlington Heights, IL 60005 36-2340313 05/03/2006 IL PET Imaging of Dallas, 8333 Douglas Avenue, C-20,Dallas, TX 75225 FTN017 05/03/2006 TX PET Imaging of Dallas—Northeast, 1250 R Northwest Highway, Garland, TX 75041 FTN028 05/03/2006 TX St Joseph's Regional Medical Center, 703 Main Street, Paterson, NJ 07503 310019 05/03/2006 NJ PET Imaging of Houston, 2493-A South Braeswood, Houston, TX 77030 FTN010 05/03/2006 TX Goshen General Hospital, 200 High Park Avenue, Goshen, IN 46526 150026 05/03/2006 IN PET Imaging of ELMC, 8550 West 38th Avenue, Suite 102, Wheat Ridge, CO 80033 800665 05/03/2006 CO PET Imaging of Houston—Southeast, 6021 Fairmont Parkway, Suite 120, Pasadena, TX 77505 FTN030 05/03/2006 TX Peninsula Imaging, LLC, 560 Riverside Drive, Suite A104, Salisbury, MD 21801 481L 05/03/2006 AL Zwanger-Pesiri, 126 Hicksville Road, Massapequa, NY 11758 W13931 05/03/2006 NY Las Calinas PET Imaging, LLP, 1110 Cottonwood Lane, Irving, TX 75038 FTN019 05/03/2006 TX Suite 220. Mt Carmel Regional Medical Center, 1102 East Centennial, Pittsburg, KS 66762 014041 05/03/2006 KS Iowa Blood & Cancer Care, PLC, 855 A. Avenue NE, Cedar Rapids, IA 52402 I6672 05/03/2006 IA Medical Office Plaza, LL4. Hackensack University Medical Center, 30 Prospect Avenue, Hackensack, NJ 07601 310001 05/03/2006 NJ McLeod PET Imaging Center, 800 East Cheves Street, Florence, SC 29501 570370242001 05/03/2006 SC Suite 170. St Alexius Medical Center, 900 E. Broadway Avenue, Bismarck, ND 58506 35-0002 05/03/2006 ND PO Box 5510. Center for Diagnostic Imaging, 1295 Orange Avenue, Winter Park, FL 32789 K0097 05/03/2006 FL Charleston Radiologists, PA, 9313 Medical Plaza Drive, Charleston, SC 29406 1709 05/03/2006 SC Suite 302. PET Imaging of Houston—West, 9525 Katy Freeway, Suite 102, Houston, TX 77024 FTN023 05/03/2006 TX University Hospitals of Cleveland, 11100 Euclid Avenue, Cleveland, OH 44106 36-0137 05/03/2006 OH Mailstop BSHB5056. PET Imaging of Sugar Land, 17320 W Grand Parkway S., Suite A, Sugar Land, TX 77479 FTN027 05/03/2006 TX PET Imaging of Oklahoma City, 1000 N. Lincoln Boulevard, Suite 250, Oklahoma City, OK 73104 800522283 05/03/2006 OK PET Imaging of Tulsa, 6711 S. Yale, #104, Tulsa, OK 74136 400522320 05/03/2006 OK PET Imaging of The Woodlands, 3091 College Park Drive, Suite 340, The Woodlands, TX 77384 FTN021 05/03/2006 TX Tarrant Diagnostic Imaging, 1121 8th Avenue, Fort Worth, TX 76104 FTN012 05/03/2006 TX Wyandot Memorial Hospital, 85 North Sandusky Avenue, Upper Sandusky, OH 43351 361329 05/03/2006 OH Oregon Health & Science University, 3181 SW Sam Jackson Park Road, Portland, OR 97229 380009 05/03/2006 OR Saint John's Health System, 2015 Jackson Street, Anderson, IN 46016 150088 05/03/2006 IN Hudson Valley PET Imaging, LLC, 160 North Midland Avenue, Nyack, NY 10960 W1L903 05/03/2006 NY Kingston Diagnostic Center, 167 Schwenk Drive, Kingston, NY 12401 W1L921 05/03/2006 NY Appleton Medical Center, 1818 N. Meade Street, Appleton, WI 54911 520160 05/03/2006 WI St. Elizabeth Health Center, 1044 Belmont Avenue, Youngstown, OH 44501 360064 05/03/2006 OH Sinai Hospital of Baltimore, 2401 West Belvedere Avenue, Baltimore, MD 21215 210012 05/03/2006 MD Associates in Radiology of Plattsburgh, NY, 762 Route 3, Suite 14, Plattsburgh, NY 12901 33572A 05/03/2006 NY Affiliated PET Systems—Rockville, 9711 Medical Center Drive, Rockville, MD 20850 FDNX01 05/03/2006 MD Lake Medical Imaging & Breast Center, 1400 US Highway 441 North, Suite 510, The Villages, FL 32159 59-3522082 05/03/2006 FL Affiliated PET Systems—Silver Spring, 1400 Forest Glen Road, Silver Spring, MD 20910 FDNX01 05/03/2006 MD Suite 430. North Texas Clinical PET Institute, 3535 Worth Street, Suite 150, Dallas, TX 75246 99R339 05/03/2006 TX Lake Imaging Center, 801 E. Dixie Avenue, Suite 104, Leesburg, FL 34748 59-3635297 05/06/2006 FL Edwards Comprehensive Cancer Center, 1400 Hal Greer Boulevard, Huntington, WV 25701 510055 05/03/2006 WV Allison Cancer Center, 301 North N Street, Midland, TX 79701 140414744 05/03/2006 TX Clinical PET of Leesburg, 8525 US Highway 441, Leesburg, FL 34748 E7179A 05/03/2006 FL Greene Medical Imaging, PC, 159 Jefferson Heights, D-106, Catskill, NY 12414 W25021 05/03/2006 NY Caritas PET Imaging, LLC—Norwood Hosp, 70 Walnut Street, Foxboro, MA 02035 32-7092 05/03/2006 MA Caritas Norwood Hospital—Foxboro Campus. Caritas PET Imaging, LLC—New England Medical Center, 750 Washington Street, Boston, MA 02111 32-7092 05/03/2006 MA Tufts—New England Medical Center. Austin, Radiological Assn.—San Marcos, 1348 B Highway 123 South, San Marcos, TX 78666 74-1597116 05/03/2006 TX ARA Imaging—Rock Creek, 2120 N Mays, #220, Round Rock, TX 78664 20-1651590 05/03/2006 TX ARA Imaging—Southwood, 1701 W. Ben White Boulevard, #170, Austin, TX 78704 20-1651590 05/03/2006 TX Elkhart General Hospital, 600 East Boulevard, Elkhart, IN 46514 15-0018 05/03/2006 IN Austin, Radiological Assn.—Midtown, 1301 W. 38th Street, Suite 100, Austin, TX 78705 74-1597116 05/03/2006 TX Caritas PET Imaging, LLC—St. Elizabeth's, 736 Cambridge Street, Boston, MA 02135 32-7092 05/03/2006 MA St. Elizabeth's Medical Center. Global PET Imaging, LLC, 1800 Hollister Drive, Suite G-10 Libertyville, IL 60048 309590 05/03/2006 IL Grand Oaks Health Center. Caritas PET Imaging, LLC—Carney Hospital, 2100 Dorchester Avenue, Dorchester, MA 02124 32-7092 05/03/2006 MA Caritas Carney Hospital. Caritas PET Imaging, LLC—Milton Hospital, 92 Highland Street, Milton, MA 02186 32-7092 05/03/2006 MA Caritas PET Imaging, LLC—St. Anne's Hospital, 795 Middle Street, Fall River, MA 02721 32-7087 05/03/2006 MA St. Anne's Hospital. Caritas PET Imaging, LLC—Good Samaritan, 235 North Pearl Street, Brockton, MA 02301 32-7087 05/03/2006 MA Caritas Good Samaritan Medical Center. Panhandle PET Imaging, 6700 W. 9th Avenue, Amarillo, TX 79106 TFN0007 05/03/2006 TX PET Imaging of San Francisco, 1700 California Street, Suite 480, San Francisco, CA 94109 ZZZ-223-782 05/03/2006 CA PET/CT Imaging of Berkeley, 2855 Telegraph Avenue, Suite 100, Berkeley, CA 94705 ZZZ-288-837 05/03/2006 CA Western Maryland Health System—Sacred Heart Campus, 902 Seton Drive, Cumberland, MD 21502 210027 05/03/2006 MD Western Maryland Health System—Sacred Heart Campus. Desert PET Imaging, LLC, 1180 N. Indian Cyn Drive, Palm Springs, CA 92262 ZZZ28648Z 05/03/2006 CA First PET of Stockton, 4744 Quail Lake Drive, Stockton, CA 95207 00A484230 05/03/2006 CA Utah Cancer Specialist, 3838 South 700 East, Salt Lake City, UT 84106 57172 05/03/2006 UT Suite 100. Washington Radiology Associates, PC, 2121 K Street, NW, Washington, DC 20006 WA409885 05/03/2006 DC Suite T-120. New Rochelle Radiology Associates, PC, 175 Memorial Highway, New Rochelle, NY 10801 W05571 05/03/2006 NY North Little Rock PET Associates, LLC, 3500 Springhill Drive, North Little Rock, AR 72117 5F437 05/03/2006 AR Suite 100. Advanced Imaging Concepts, PL, 13063 Cortez Boulevard, Brooksville, FL 34613 94774 05/03/2006 FL Mansfield Imaging Center, 536 S. Trimble Road, Mansfield, OH 44906 MAD10921 05/03/2006 OH West Tennessee Imaging Center, 300 Coatsland Drive, Jackson, TN 38305 44-0002 05/03/2006 TN Imaging Center of North Central Indiana, Inc., 2201 W. Boulevard, Kokomo, IN 46902 224110 05/03/2006 IN University of Kansas Hospital, 3901 Rainbow Boulevard, Kansas City, KS 66160 17-00040 05/03/2006 KS Division of Nuclear Medicine. PET Imaging of SWLA, LLC, 600 Bayou Pines East, Lake Charles, LA 70601 5CK63 05/03/2006 LA Suite A. Community Imaging Partners of Frederick, 67 Thomas Johnson Drive, Frederick, MD 21702 980M 05/03/2006 MD Community Imaging Partners of Olney, 18111 Prince Phillip Drive #T-20, Olney, MD 20832 409410 05/03/2006 MD Community Imaging Partners. The West Clinic, PC, 100 N. Humphreys Boulevard, Memphis, TN 38120 3704066 05/03/2006 TN Imaging Central LLC, 7111 W. Central Avenue, Toledo, OH 43617 IMID01641 05/03/2006 OH Advanced Radiology—Dixon, 291 Stoner Avenue, Westminster, MD 21157 527L 05/03/2006 MD Advanced Radiology—Harford Imaging, 104 Plumtree Road, Bel Air, MD 21015 527L 05/03/2006 MD Suite 106. Advanced Radiology—Cross Roads, 4801 Dorsey Hall Road, Ellicott City, MD 21042 527L 05/03/2006 MD Suite 101. Advanced Radiology—PET Imaging of MD, 1700 Reisterstown Road, Baltimore, MD 21208 527L 05/03/2006 MD Suite 119. Cancer & Blood Disease Center, 521 N. Lecanto Highway, Lecanto, FL 34461 72840 05/03/2006 FL Huntington Outpatient Imaging Center, Inc., 800 S. Fairmount Avenue, Pasadena, CA 91105 W1575B 05/03/2006 CA Suite 120. Universal Imaging, Inc., 4600 Investment Drive, Troy, MI 48083 ON69130 05/03/2006 MI Berger Health System, 1170 North Court Street, Circleville, OH 43113 360710 05/03/2006 OH Contemporary Imaging—Trenton, 1676 Fort Street, Trenton, MI 48183 0P23200 05/03/2006 MI South Tulsa PET, LLC, 7712 S. Yale Avenue, Tulsa, OK 74136 800522360 05/03/2006 OK Ste 100. Cancer Center of the Carolinas, 200 Andrews Street, Greenville, SC 29601 6526 05/03/2006 SC Suite 100. OSF Saint Francis Medical Center, 530 NE Glen Oak Avenue, Peoria, IL 61637 14-0067 05/03/2006 IL Sacred Heart—St. Mary's Hospitals, Inc., 2251 Northshore Drive, Rhinelander, WI 54501 1100700 05/03/2006 WI Capital Region Radiation Therapy & Imaging, 3400 W. Truman Boulevard, Jefferson City, MO 65109 260047 05/03/2006 MO PO 150832. University PET/CT Imaging, 19 Bradhurst Avenue, Hawthorne, NY 10532 W2Y371 05/03/2006 NY Suite 1200. Aztech Radiology—Apache Trail, 1840 W. Apache Trail, Apache Junction, AZ 85222 Z72398 05/03/2006 AZ Aztech Radiology—Casa Grande, 1669 E McMurray Boulevard, Casa Grande, AZ 85222 Z25341 05/03/2006 AZ Missouri Cancer Associates, 105 N. Keene Street, Columbia, MO 65201 000012700 05/03/2006 MO Suite 100. White River Medical Center, 1710 Harrison Street, Batesville, AR 72501 040119 05/03/2006 AR Englewood Hospital & Medical Center, 350 Engle Street, Englewood, NJ 07631 310045 05/03/2006 NJ Regional Imaging & Therapeutic Radiology Services, 360 Bard Avenue, Staten Island, NY 10310 1023095445 05/03/2006 NY Rocky Mountain Cancer Centers—South, 7951 E. Maplewood Avenue, Suite 300, Greenwood Village, CO 80111 204508 05/03/2006 CO Rocky Mountain Cancer Centers—North, 7951 E. Maplewood Avenue, Suite 300, Greenwood Village, CO 80111 204508 05/03/2006 CO Molecular Imaging of Hamilton County—Bethesda, 4197 Fulton Road NW, Suite C, Canton, OH 44718 MOID01221 05/03/2006 OH Molecular Imaging of Hamilton County—Good Sam, 4197 Fulton Road NW, Suite C, Canton, OH 44718 MOID01221 05/03/2006 OH Kettering Medical Center, 3535 Southern Boulevard, Kettering, OH 45429 360079 05/03/2006 OH St. Mary's Hospital, 5801 Bremo Road, Richmond, VA 23226 540793767 05/03/2006 VA Columbus Medical Institute of NY, 97-85 Queens Boulevard, Rego Park, NY 11374 05679 05/03/2006 NY Meadville Medical Center, 1034 Grove Street, Meadville, PA 16335 39-0113 05/03/2006 PA Chambersburg Hospital—Radiology, 112 North Seventh Street, Chambersburg, PA 17201 390151 05/03/2006 PA Oregon Advanced Imaging, 881 O'Hare Parkway, Medford, OR 97504 R114546 05/03/2006 OR Singing River Hospital, 2809 Denny Avenue, Pascagoula, MS 39581 250040 05/03/2006 MS East Texas Medical Center—Tyler, 1000 S. Beckham Avenue, Tyler, TX 75701 4500833 05/03/2006 TX Columbia, St. Mary's Hospital, 2025 E. Newport Avenue, Columbia Campus, Milwaukee, WI 53211 520051 05/03/2006 WI Sharon Regional Health System, 740 East State Street, Sharon, PA 16146 390211 05/03/2006 PA Northern Ohio Imaging Center, 1900 West River Road, Elyria, OH 44035 36-0172 05/03/2006 OH Oxford Valley Diagnostic Center, 940 Town Center Drive, Langhorne, PA 19047 232745550 05/03/2006 PA Suite F50. The Emory Clinic, 1365 Clifton Road, Building C, Room Court 048, Atlanta, GA 30322 582030692 05/03/2006 GA Alegent Health Bergan Mercy Medical Center, 7500 Mercy Road, Omaha, NE 68124 280060 05/03/2006 NE University Center Imaging, 1065 Delaware Avenue, Marion, OH 43302 20-3873307 05/03/2006 OH Elk Regional Health Center, 763 Johnsonburg Road, St Mary's, PA 15857 39-0154 05/03/2006 PA Health Park Hospital, 1636 Higdon Ferry Road, Hot Springs, AR 71913 04-0142 05/03/2006 AR Johnsonburg Health Center, 81 Clarion Road, Johnsonburg, PA 15845 39-0104 05/03/2006 PA Jane Phillips Medical Center, 3500 E. Frank Phillips Boulevard, Bartlesville, OK 74006 370015 05/03/2006 OK North Main Imaging Center, 7650 First Place, Suite B, Oakwood Village, OH 44146 NEID01521 05/03/2006 OH PET Imaging Center of Delaware County—DCMH, 501 North Lansdowne Avenue, Drexel Hill, PA 19026 390081 05/03/2006 PA NEO—PET CRC Imaging, 7650 First Place, Suite B, Oakwood Village, OH 44146 NEID01521 05/03/2006 OH PET Imaging Center of Delaware County—Springfield, 190 West Sproul Road, Springfield, PA 19064 381080 05/03/2006 PA Harper University Hospital, 3990 John R Street, Detroit, MI 48201 230104 05/03/2006 MI Sinai-Grace Hospital, 6071 W. Outer Drive, Detroit, MI 48235 23-0024 05/03/2006 MI Seattle Radiologists APC, 1229 Madison Street, Seattle, WA 98104 G0001589600 05/03/2006 WA #900. Huron Valley—Sinai Hospital, 1 William Carl Drive, Commerce, MI 48382 23-0277 05/03/2006 MI East Memphis PET Imaging, 6005 Park Avenue, Memphis, TN 38119 3374526 05/03/2006 TN Suite 101B. UPMC—PET Imaging Facility, 200 Lothrop Street, Pittsburgh, PA 15213 390164 05/03/2006 PA 9th Floor, B-Wing PUH. UPMC—PET Imaging Facility, 300 Halket Street, Pittsburgh, PA 15213 390114 05/03/2006 PA Rhode Island Hospital, 593 Eddy Street, Providence, RI 02903 05-025-8954 05/03/2006 RI David C. Pratt Cancer Center, 607 South New Bulbs Road, St Louis, MO 63141 260020 05/03/2006 MO Lewistown Hospital, 400 Highland Avenue, Lewistown, PA 17044 390048 05/03/2006 PA Lawrence Memorial Hospital, 325 Maine Street, Lawrence, KS 66044 170137 05/03/2006 KS Jameson Hospital, 1211 Wilmington Avenue, New Castle, PA 16105 39-0016 05/03/2006 PA Diagnostic Clinic of Houston, 1200 Binz Street, Houston, TX 77004 76-0203506 05/03/2006 TX Arlington Heights Radiology Center, LLC, 121 South Wilke Road, Arlington Heights, IL 60005 212301 05/03/2006 IL Oregon Imaging Center, 1200 Hilyard Street, Eugene, OR 97401 R0000WCPGH 05/03/2006 OR #330. Arlington Heights Radiology Center, LLC, 121 South Wilke Road, Arlington Heights, IL 60005 212301 05/03/2006 IL Indiana Univ Radiology Assoc PET Imaging Center, 950 W. Walnut Street, Room E124, Indianapolis, IN 46202 959090 05/03/2006 IN Morristown Memorial Hospital, 100 Madison Avenue, Morristown, NJ 07962 310015 05/03/2006 NJ Baton Rouge Radiology Group, 5422 Dijon Drive, Baton Rouge, LA 70808 5B039 05/03/2006 LA North Texas PET Imaging, 3720 South I-35E, Denton, TX 76210 752131429 05/03/2006 TX Children's Hospital of Michigan PET Center, 3901 Beaubien Street, Detroit, MI 48201 23-3300 05/03/2006 MI Winchester Medical Center, 1840 Amherst Street, Winchester, VA 22601 490005 05/03/2006 VA Decatur Health Imaging, LLC, 1123 16th Avenue SE, Decatur, AL 35601 051555161 05/03/2006 AL Health Imaging Services, LLC, 1760 Warnke Circle NE, Cullman, AL 35058 051553273HEA 05/03/2006 AL PET/CT Imaging of the Mainline, 21 Industrial Boulevard, Suite 103 Paoli, PA 19301 097715 05/03/2006 PA PET Imaging of Brevard, 1430 Pine Street, Melbourne, FL 32901 39254 05/03/2006 FL North Carolina Baptist Hospital, Medical Center Boulevard, Winston Salem, NC 27157 34-0047 05/03/2006 NC St Francis Hospital, 34515 9th Avenue S, Federal Way, WA 98003 500108 05/03/2006 WA Saint Barnabas Outpatient Center, 200 S. Orange Avenue, Livingston, NJ 07039 440149 05/03/2006 NJ PET/CT Imaging of Ramapa Radiology, 972 Route 45, Suite 106, Pomona, NY 10970 W21711 05/03/2006 NY Medical University of South Carolina PET/CT, 169 Ashley Avenue, Charleston, SC 29425 420004 05/03/2006 SC Akron General Medical Center, 300 Wabash Avenue, Akron, OH 44307 36-0027 05/03/2006 OH New England Molecular Imaging—Mercy Hospital, 144 State Road, Portland, ME 04103 NE327075 05/03/2006 ME New England Molecular Imaging—Penobscot Bay, 6 Glenn Cove Drive, Rockport, ME 04856 NE327076 05/03/2006 ME Center for Outpatient Services—St. Joseph, 3900 Hollywood Road, St. Joseph, MI 49085 23-0021 05/03/2006 MI New England Molecular Imaging—Central Maine, 12 High Street, Lewiston, ME 04240 NE327076 05/03/2006 ME Imaging Consultants, Inc.—Berkshire, 8 Conte Drive, Pittsfield, MA 01210 327085 05/03/2006 MA Imaging Consultants, Inc.—Boston Medical, 840 Harrison Avenue, Boston, MA 02118 327083 05/03/2006 MA Imaging Consultants, Inc.—Boston PET, One Brookline, Place, Brookline, MA 02445 327083 05/03/2006 MA Baptist Memorial Hospital PET Center, 6027 Walnut Grove Road, Memphis, TN 38120 44-0048 05/03/2006 TN Southern Oklahoma PET/CT Imaging, 701 E. Robinson Street, Norman, OK 73071 90015477 05/03/2006 OK Ann G. Fetters Diagnostic Imaging Center, 2151 N. Harbor Boulevard, Fullerton, CA 92835 050168 05/03/2006 CA Pitt County Memorial Hospital, 2100 Stantonsburg Road, Greenville, NC 27835 56-0585243 05/03/2006 NC Inland Imaging, LLC, 105 W. 8th Avenue, Spokane, WA 99202 AB01749 05/03/2006 WA Suite 100C. University of Chicago Hospitals, 5758 S. Maryland Avenue, Chicago, IL 60637 140088 05/03/2006 IL Room #0150. Birch Medical Imaging Center, 20162 SW Birch Street, Newport Beach, CA 92660 W19353 05/03/2006 CA Tennessee Oncology PET Services, 2018 Murphy Avenue, Nashville, TN 37203 3709319 05/03/2006 TN Suite 200. Tennessee PET Scan, 1020 N. Highland Avenue, Murfreesboro, TN 37130 3791187 05/03/2006 TN Suite A. Texas Oncology—Harris Center HEB, 1615 Hospital Parkway, Bedford, TX 76022 00R66C 05/03/2006 TX Suite 300. Greater Dayton Cancer Center, 3120 Governor's Place Boulevard, Kettering, OH 45409 9295791 05/03/2006 OH Martha Jefferson Hospital, 459 Locust Avenue, Charlottesville, VA 22902 490077 05/03/2006 VA Modern Diagnostic Imaging, 600 S. Dobson Road, Chandler, AZ 85224 107628 05/03/2006 AZ Suite B-16. Christiana Care Nuclear Medicine/PET, 4755 Ogletown-Stanton Road, Newark, DE 19718 080001 05/03/2006 DE Advanced Imaging of Port Charlotte, LLC, 2625 Tamiami Trail, Port Charlotte, FL 33952 K6802 05/03/2006 FL Suite 1. St. Joseph's Diagnostic Center—MLK, 3003 Martin Luther King, Jr. Boulevard, Tampa, FL 33067 97779 05/03/2006 FL South Carolina Oncology Associates, 166 Stoneridge Drive, Columbia, SC 29210 6275 05/03/2006 SC South Carolina Oncology Associates, 166 Stoneridge Drive, Columbia, SC 29210 6276 05/03/2006 SC Access Health Imaging, 5257 Highway 82, East, Lake Village, AR 71653 5M809 05/03/2006 AR PET/CT Services of Florida—Beverly Hills, 3404 N. Lecanto Highway, Beverly Hills, FL 34465 V0103 05/03/2006 FL Beverly Hills Medical Park. PET/CT Services of Florida—Ocala, 1541 SW 1st Avenue, Ocala, FL 34474 V0103 05/03/2006 FL Suite 101B. Blanchard Valley Regional Health Center, 145 W. Wallace Street, Findlay, OH 45840 360095 05/03/2006 OH Papastavros Associates Medical Imaging, 1701 Augustine Cut-Off, Wilmington, DE 19803 1083615561 05/03/2006 DE PET Imaging of Willowbrook, 13300 Hargrave Road, Houston, TX 77070 FTN032 05/03/2006 TX Suite 130. PET Imaging of Northern Colorado, 1915 Wilmington Drive, Ft Collins, CO 80528 804621 05/03/2006 CO Suite 101. Temecula Valley Advanced Imaging, 25395 Hancock Avenue, Murrieta, CA 92592 ZZZ-150752 05/03/2006 CA Suite 110. Saint Anthony Memorial Health Center, 301 West Homer Street, Michigan City, IN 46360 A150015 05/03/2006 IN Salina Regional Health Center, 400 S. Santa Fe Avenue, Salina, KS 67401 170012 05/03/2006 KS PO Box 5080. Cancer Center of Kansas, 818 N. Emporia Street, Wichita, KS 67214 110217 05/03/2006 KS Suite 100. Clinton Crossings Imaging, 995 Senator Keating Boulevard, Rochester, NY 14618 14439A 05/03/2006 NY NSMS—Shelby County, 4253 Argosy Court, Madison, WI 53714 I16068 05/03/2006 WI Verrazano Radiology, PC, 256A Mason Avenue, Staten Island, NY 10305 200011201 05/03/2006 NY Imaging Consultants, Inc.—Brockton Hospital, 680 Centre Street, Brockton, MA 02301 327085 05/03/2006 MA Imaging Consultants, Inc.—Cape Cod, 252 Long Pond Drive, Harwich, MA 02645 327085 05/03/2006 MA Fontain Medical Center. Imaging Consultants Inc—Falmouth, 100 Ter Hewn Drive, Falmouth, MA 02540 327085 05/03/2006 MA Imaging Consultants, Inc.—Jordan, 275 Sandwich Street, Plymouth, MA 02360 327085 05/03/2006 MA Imaging Consultants, Inc.—Holyoke, 575 Beech Street, Holyoke, MA 01040 327085 05/03/2006 MA Imaging Consultants, Inc.—Mercy Medical, 271 Carew Street, Springfield, MA 01089 327085 05/03/2006 MA Imaging Consultants, Inc.—Lawrence Memorial, 170 Governors Avenue, Medford, MA 02155 327083 05/03/2006 MA Imaging Consultants, Inc.—Metro West, 115 Lincoln Street, Framingham, MA 01701 327083 05/03/2006 MA Imaging Consultants, Inc.—Milford, 14 Prospect Street, Milford, MA 01757 327085 05/03/2006 MA Imaging Consultants, Inc.—Quincy, 114 Whitwell Street, Quincy, MA 02196 327083 05/03/2006 MA Imaging Consultants, Inc.—Saints Memorial, 2 Hospital Drive, Lowell, MA 01852 327083 05/03/2006 MA Imaging Consultants, Inc.—Truesdale, 1030 Presidents Avenue, Fall River, MA 02720 327085 05/03/2006 MA Imaging Consultants, Inc.—Twin City, 76 Summer Street, Fitenburg, MA 01420 N/A 05/03/2006 MA Imaging Consultants, Inc.—Worcester, 20 Worcester Center Boulevard, Worcester, MA 01608 327085 05/03/2006 MA Sentara Mobile PET/CT—Careplex, 5900 Lake Wright Drive, Suite B, Norfolk, VA 23502 250605 05/04/2006 VA Sentara Mobile PET/CT—Lake Wright, 5900 Lake Wright Drive, Suite B, Norfolk, VA 23502 250605 05/04/2006 VA Sentara Mobile PET/CT—Princess Anne, 5900 Lake Wright Drive, Suite B, Norfolk, VA 23502 250605 05/04/2006 VA Sentara Mobile PET/CT—Williamsburg, 5900 Lake Wright Drive, Suite B, Norfolk, VA 23502 250605 05/04/2006 VA Memorial Hospital of South Bend, 615 N. Michigan Street, South Bend, IN 46601 150058 05/04/2006 IN NSMS—Belleville, IL, 4253 Argosy Court, Madison, WI 53714 208196 05/04/2006 WI NSMS—Flora, IL, 4253 Argosy Court, Madison, WI 53714 208196 05/04/2006 WI NSMS—Breese, IL, 4253 Argosy Court, Madison, WI 53714 208196 05/04/2006 WI SSM DePaul Health Center, 12303 DePaul Drive, St Louis, MO 63044 260104 05/04/2006 MO Lutheran Hospital, 7950 W. Jefferson Boulevard, Fort Wayne, IN 46804 150017 05/11/2006 IN Memorial MRI and Diagnostic, 1346 Campbell Road, Houston, TX 77055 00941U 05/11/2006 TX Shields Imaging of Eastern Mass, 55 Fogg Road, Weymouth, MA 2190 327088 05/11/2006 MA Baystate MRI and Imaging Center, 3300 Main Street, Springfield, MA 1107 327039 05/11/2006 MA Advanced Imaging Center, 16110 Jog Road, 200, Delray Beach, FL 33446 U2049 05/11/2006 FL UMASS Memorial MRI and Imaging Center, 214 Shrewsburg Street, Worcester, MA 1604 327040 05/11/2006 MA RCOA Imaging Services, 1108 Minnequa Avenue, Pueblo, CO 81004 475748 05/11/2006 CO Adventist Health PET/CT—Hanford, 450 N. Greenfield Avenue, Hanford, CA 93230 ZZZ318852 05/11/2006 CA Adventist Health PET/CT—Feather River, 5974 Pertz Road, Paradise, CA 95969 ZZZ318852 05/11/2006 CA Adventist Health PET/CT—Sonora, 1000 Greenley Road, Sonora, CA 95370 ZZZ318852 05/11/2006 CA Sarasota Memorial PET, 5350 University Parkway, Sarasota, FL 34238 U1775 05/11/2006 FL Adventist Health PET/CT—Redbud, 18th Ave. at Highway 53, PO Box 6710, Clear Lake, CA 95422 ZZZ318852 05/11/2006 CA Adventist Health PET/CT—St. Helena, 10 Woodland Road, St. Helena, CA 94574 ZZZ318852 05/11/2006 CA Adventist Health PET/CT—Ukiah, 275 Hospital Drive, Ukiah, CA 95482 ZZZ318852 05/11/2006 CA Mease Outpatient Imaging, 1840 Mease Drive, Safety Harbor, FL 34685 100265 05/11/2006 FL Bardmoor Outpatient Center, 8787 Bryan Dairy Road, Largo, FL 33777 00594C 05/11/2006 FL Trinity Outpatient Center, 2102 Trinity Oaks Boulevard, New Port Richey, FL 34655 00594D 05/11/2006 FL Walnut Creek Imaging Center, 114 La Casa Via, #200, Walnut Creek, CA 94598 ZZZ13902Z 05/11/2006 CA Carlisle Imaging Center, 1240 S. Ft. Harrison, Clearwater, FL 33756 594 05/11/2006 FL Valley Radiology Imaging at Samaritan, 2581 Samaritan Drive, #100, San Jose, CA 95124 ZZZ139851Z 05/11/2006 CA Forest Hills PET Imaging, 102-02 Queens Boulevard, Forest Hills, NY 11375 06998G 05/11/2006 NY Roper LowCountry PET Imaging Center, 316 Calhoun Street, Charleston, SC 29401 Q326280001 05/11/2006 SC Premier PET Imaging of NJ, 119 Cherry Hill Road, Parsippany, NJ 07054 68433 05/11/2006 NJ Suite 100. Methodist Medical Center of Illinois, 221 NE Glen Oak Avenue, Peoria, IL 61636 370661223 05/11/2006 IL Medical Imaging of Baltimore, 6715 N. Charles Street, Baltimore, MD 21204 258L 05/12/2006 MD Yagnesh Oza, MD, 4117 Velerous Memorial Drive, Mt Vernon, IL 62864 212702 05/12/2006 IL Moffitt Cancer Center, 12902 Magnolia Drive, Tampa, FL 33612 100271 05/12/2006 FL PrimeMed Imaging, 5 Morgan Highway, Suite 7, Scranton, PA18505 260 05/12/2006 PA Morgan Medical Complex. Rockville PET Imaging, PC, 119 North Park Avenue, Rockville Centre, NY 11570 WTC601 05/12/2006 NY Suite 101. Porter Adventist Hospital, 2525 South Downing Street, Denver, CO 80210 60064 05/12/2006 CO Rapid City Regional Hospital Medical Imaging Services, 353 Fairmont Boulevard, Rapid City, SD 57701 43007 05/12/2006 SD Advanced Radiolgy Consultants, 56 Quarry Road, Trumbull, CT 06611 C02747 05/12/2006 CT Northeastern PA Imaging Center, 2601 Stafford Avenue, Scranton, PA 18505-0305 475385 05/12/2006 PA PO BOX 3305. Billings MRI Center, 1041 North 29th Street, Billings, MT 59101-1075 81030 05/12/2006 MT Aurora St. Luke's Medical Center, 2900 W. Oklahoma Avenue, Milwaukee, WI 53215 520138 05/12/2006 WI Nuclear Medicine Department. Memorial & St. Elizabeth's Healthcare Services, LLC, 4000 N. Illinois Lane, Swansea, IL 62226 201339 05/12/2006 IL PET/CT Imaging Center. Palm Beach Cancer Institute—West Palm Beach, 1309 North Flagler Drive, West Palm Beach, FL 33401-2710 34754 05/12/2006 FL Overlook Hospital, 99 Beauvoir Avenue, Summit, NJ 07902 8772966189 05/12/2006 NJ Ashland Bellefonte Cancer Center, 122 Saint Christopher Drive, Ashland, KY 41101 2150 05/12/2006 KY Bryn Mawr Imaging Center, 101 S. Bryn Mawr Avenue, Bryn Mawr, PA 19010 473120 05/12/2006 PA Oncology Alliance, 1055 N. Mayfair Road, Suite 100, Wauwatosa, WI 53220 32836000 05/12/2006 WI Shared PET Maimonides, 6300 Eighth Avenue, Brooklyn, NY 11220 97Z661 05/12/2006 NY Hoboken Radiology, LLC, 79 Hudson Street, Suite 100, Hoboken, NJ 07030 80395 05/12/2006 NJ Akron City Hospital, 525 E. Main Street, Akron, OH 44309 360020 05/12/2006 OH Park Avenue Radiologists, PC, 525 E. Main Street, Rome, GA 30165 W21771 05/12/2006 NY Comprehensive Blood & Cancer Center, 6501 Truxtun Avenue, Bakersfield, CA 93309 zzz238732 05/12/2006 CA Rome Imaging Center, 309 West 10th Street, Rome, GA 30165 GRP1221 05/12/2006 GA Hawaii PET Imaging, 2230 Liliha Street, Honolulu, HI 96817 54537 05/12/2006 HI Imaging Consultants, Inc. at Henry Heywood Hospital, 242 Green Street, Gardner, MA 01440 327085 05/12/2006 MA Imaging Consultants, Inc. at Nashoba Valley Medical Center, 200 Groton School Road, Ayer, MA 01432 327085 05/12/2006 MA Rhode Island PET Services at Memorial Hospital, 111 Brewster Street, Pawtucket, RI 2860 479003556 05/12/2006 RI Osceola Cancer Center, 737 W. Oak Street, Kissimmee, FL 34741 1629034202 05/12/2006 FL Valley Radiologists, Ltd.—Paseo II Office, 5605 W. Eugie Avenue, Suite 110, Glendale, AZ 85304 1902896236 06/13/2006 AZ Southeast GYN, Oncology PET, 5210 Belfort Road, Suite 130, Jacksonville, FL 32256 45542 06/13/2006 FL The Johns Hopkins PET Center, 600 N. Wolfe Street, Baltimore, MD 21287 210009 06/13/2006 MD Nelson Basement. Maklansky, Grunter, Kurzban, Cohen, Zimmer, Hyman, 165 East 84th Street, New York, NY 10028 W20393 06/13/2006 NY Methodist Medical Center of Illinois, 112 Crescent Avenue, Peoria, IL 61636 370661223 06/13/2006 IL Phoebe Putney Memorial Hospital, 417 Third Avenue, PO Box 1828, Albany, GA 31702-1828 110007 06/13/2006 GA Eiber Radiology/PET Premier Imaging, 21 West 49th Street, Hialeah, FL 33012 k3166 06/13/2006 FL Botsford Hospital, 28050 Grand River Avenue, Farmington Hills, MI 48336 230151 06/13/2006 MI Middletown Regional Hospital, 105 McKnight Drive, Middletown, OH 45044 360076 06/13/2006 OH Waukesha Memorial Hospital, 725 American Avenue, Waukesha, WI 53188 390910727 06/13/2006 WI Battle Creek Health System, 300 North Avenue, Battle Creek, MI 49016 230075 06/13/2006 MI Orlando Regional Medical Center, 1414 Kuhl Avenue, Orlando, FL 32806 100006 06/13/2006 FL NorthEast Medical Center, 1065 NorthEast Gateway Court NE, Concord, NC 28025 340001 06/13/2006 NC Premier Medical Imaging, 7651 Stagers Loop, Delaware, OH 43015 9912921 06/13/2006 OH Advanced Radiolgy Consultants, 15 Corporate Drive, Trumbull, CT 6611 C02747 06/13/2006 CT Advance PET Imaging, 23 Technology Drive, East Setauket, NY 11733 46a401 06/13/2006 NY Premier PET Imaging of Wichita, 500 S. Main Street, Suite B, Wichita, KS 67202 110682 06/13/2006 KS Health Center Northwest, 320 Sunnyview Lane, Kalispell, MT 59901 270087 06/13/2006 MT Olympic Medical Center, 844 N. 5th Avenue, Sequim, WA 98382 500072 06/13/2006 WA Premier PET Imaging of Jacksonville, 5210 Belfort Road, Suite 130, Jacksonville, FL 32256 K3166 06/13/2006 FL PET/CT Imaging of San Jose, 2211 Moorpark Avenue, Suite 220, San Jose, CA 95128 ZZZ19866Z 06/13/2006 CA The Reading Hospital and Medical Center, 6th and Spruce Streets, West Reading, PA 19611 390044 06/13/2006 PA Julia Rackley Perry Memorial Hospital, 530 Park Avenue East, Princeton, IL 61356 141337 06/13/2006 IL Ashland Bellefonte Cancer Center, 122 Saint Christopher Drive, Ashland, KY 41101 2150 06/13/2006 KY Tower Imaging BBD, 14231 Bruce B Down Boulevard, Tampa, FL 33613 169 06/13/2006 FL VyMed Diagnostic Imaging Tampa, LLC, 10010 N. Dale Mabry, Suite 160, Tampa, FL 33618 U4068 06/13/2006 FL Texas Oncology Cancer Center Sugar Land, 1350 First Colony Boulevard, Sugar Land, TX 77479 00073F 06/13/2006 TX Samaritan North Health Center, 9000 N. Main Street, Dayton, OH 45415 360052 06/13/2006 OH The PET Center of Oxford, 1612 US Highway 78 East, Suite 102, Oxford, AL 36203 51554888 06/13/2006 AL Shared PET Mem Lighthouse, 6901 N. Main Street, Granger, IN 46530 232800 06/13/2006 IN Shared PET Hope Cancer Center, 3702 South Fourth Street, Terre Haute, IN 47802 201320 06/13/2006 IN Athens Regional Medical Center, 1199 Prince Avenue, Athens, GA 30606 110074 06/13/2006 GA Muskogee PET & Nuclear Imaging, 3300 Chandler Road, Suite #106 Muskogee, OK 74403 400522529 06/13/2006 OK Lubbock Imaging Center, 4011 19th Street, Lubbock, TX 79410 00027K 06/13/2006 TX Memorial Medical Center, 701 N. First Street, Springfield, IL 62781 140148 06/13/2006 IL Hamamatsu/Queen's PET Imaging Center, 1301 Punchbowl Street, Honolulu, HI 96813 06/13/2006 HI Aurora BayCare Medical Center, 2845 Greenbrier Road, Green Bay, WI 54308 520193 06/13/2006 WI Medical Center of Plano, 3901 W. 15th Street, Plano, TX 75002 450651 06/13/2006 TX Carolinas Medical Center, 1000 Blythe Boulevard, Charlotte, NC 28203 340113 06/13/2006 NC Redwood Regional Medical Group d.b.a. Santa Rosa Radiology, 121 Sotoyome Street, Santa Rosa, CA 95405 680344865 06/13/2006 CA Boone Hospital Center, 1600 East Broadway, Columbia, MO 65201 260068 06/13/2006 MO River Radiology, 45 Pine Grove Avenue, Kingston, NY 12401 W30681 06/13/2006 NY University of Washington Medical Center, 1959 NE Pacific Street, Seattle, WA 98195 142700 06/13/2006 WA Mid American Imaging—Salem, 1987 E. 4th Street, Salem, OH 44460 ID00804 06/13/2006 OH Piedmont Medical Center, 222 S. Herlong Avenue, Rock Hill, SC 29732 420002 06/13/2006 SC Alliance Imaging—Sparks, 1311 South I Street, Fort Smith, AR 72817 5F463 06/13/2006 AR Radiology Imaging Associates, 1825 SE Tiffany Avenue, Suite 104, Port St. Lucie, FL 34952 52 06/13/2006 FL Mount Sinai Medical Center, One Gustave L. Levy Place, New York, NY 10029 H23620 06/13/2006 NY NSMS—Ottawa, IL, 4253 Argosy Court, Madison, WI 53714 208196 06/13/2006 WI Center for Diagnostic Imaging, 1550 E. Chestnut Avenue, Vineland, NJ 08360 53290 06/13/2006 NJ Bldg 4, Suite A. St. Mary Mercy Hospital—Livonia, 36475 Five Mile Road, Livonia, MI 48154 230002 06/13/2006 MI Harold Leever Regional Cancer, 1075 Chase Parkway, Waterbury, CT 06708 470000025 06/13/2006 CT Kentucky Metabolic Imaging, 2425 Regency Road, Suite B, Lexington, KY 40503 9366001 06/13/2006 KY Western Baptist Hospital, 2501 Kentucky Avenue, Paducah, KY 42001 180104 06/13/2006 KY St. Anthony Regional Hospital, 311 South Clark Street, Box 628, Carroll, IA 51401 1720067127 06/13/2006 IA Alliance Imaging—Sequoia Hospital, 170 Alameda De Las Pulgas, Redwood City, CA 94062 ZZZ28890Z 06/13/2006 CA Craven Regional Medical Center, 2000 Neuse Boulevard, New Bern, NC 28560 340131 06/13/2006 NC Alliance Imaging—Tri City Medical Center, 4002 Vista Way, Oceanside, CA 92056 TG281C 06/13/2006 CA Alliance Imaging—Yavapai, Del Webb Outpatient Center, Prescott Valley, AZ 86314 76103 06/13/2006 AZ 3262 Windsong Drive. Saint Vincent's Comprehensive Cancer Center, 325 West 15th Street, New York, NY 10011 330290 06/13/2006 NY Alliance Imaging—Southwest Medical Imaging, 3104 Stockton Hill Road, Kingman, AZ 86401 76103 06/13/2006 AZ Alliance Imaging—North Idaho Imaging, 700 Ironwood Drive, Coeur d'Alene, ID 93814 1790291 06/13/2006 ID Froedtert Hospital, 9200 W. Wisconsin Avenue, Milwaukee, WI 53226 520177 06/13/2006 WI Alliance Imaging—Flagstaff Medical Center, 1200 N. Beaver Street, Flagstaff, AZ 86001 71855 06/13/2006 AZ South Florida Oncology and Hematology Consultants, 4850 W. Oakland Park Boulevard, Lauderdale Lakes, FL 33313 33873 06/13/2006 FL Suite A. Alliance Imaging—Sierra Vista, 300 El Camino Real, Sierra Vista, AZ 85635 71855 06/13/2006 AZ Alliance Imaging—St. Joseph Eureka, 2700 Dolbeer Street, Eureka, CA 95501 zzz23046z 06/13/2006 CA Alliance Imaging—Corvallis Clinic, 3680 NW Samaritan Drive, Corvallis, OR 97330 132104 06/13/2006 OR Bridgeport Hospital, 267 Grant Street, Bridgeport, CT 06610 70010 06/13/2006 CT Valley Radiologists, Ltd.—Paseo II Office, 5605 W. Eugie Avenue, Glendale, AZ 85304 1902896236 06/13/2006 AZ Suite 110. Central Texas Medical Center, 1301 Wonder World Drive, San Marcos, TX 78666 450272 06/13/2006 TX Alliance Imaging—Verde Valley Medical Center, 269 S. Candy Lane, Cottonwood, AZ 86326 76103 06/13/2006 AZ Alliance Imaging—Union Hospital Cecil, 106 Bow Street, Elkton, MD 21821 FMN008 06/13/2006 MD St. Joseph Mercy Hospital—Ann Arbor, 5301 E. Huron River Road, Ann Arbor, MI 48106 230156 06/13/2006 MI Alliance Imaging—Navapache, 2200 E. Show Low Lake, Show Low, AZ 85901 76103 06/13/2006 AZ St. Clare Medical Center, 1710 Lafayette Road, Crawfordsville, IN 17933 150022 06/13/2006 IN Boynton Beach EFL, Imaging Center, LLC, 2300 S. Congress Avenue, Boynton Beach, FL 33426 272376000 06/13/2006 FL #105. Aurora Medical Center Oshkosh, 855 N. Westhaven Drive, Oshkosh, WI 54904 590198 06/13/2006 WI Southeast GYN, Oncology PET, 5210 Belfort Road, Jacksonville, FL 32256 45542 06/13/2006 FL Suite 130. Stockton MRI & Molecular Imaging Medical Center, 2320 N. California Street #2, Stockton, CA 95219 ZZZ290872 06/13/2006 CA South Texas Cancer Center, 2150 N. Expressway 83, Brownsville, TX 78521 14041756 06/13/2006 TX Southwest Cancer Care Medical Group, 5395 Ruffin Road, San Diego, CA 92123 W4957B 06/13/2006 CA #202. Radiology Associates of Venice and Englewood, PA, 512-516 S. Nokomis Avenue, Venice, FL 34285 99390 06/13/2006 FL Langlade Memorial Hospital Oncology, 112 E. 5th Avenue, Antigo, WI 54409 521350 06/13/2006 WI RCOA Imaging Services, 305 South 5th Street, Enid, OK 73701 400522301 06/13/2006 OK North Shore Hematology Oncology Associates, PC, 235 N. Belle Mead Road, East Setauket, NY 11733 W04051 06/13/2006 NY Providence Holy Cross Imaging Center, 26357 McBean Parkway, Suite 155, Santa Clarita, CA 91355 TP129 06/13/2006 CA Alaska Open Imaging Center, LLC, 6911 DeBarr Road, Anchorage, AK 99504 K153149 06/13/2006 AK Temecula Valley Nuclear Medicine, 25485 Medical Center Drive, Murrieta, CA 92562 00A417170 06/13/2006 CA Suite 102. Hematology Oncology Assoc. of the Treasure Coast, 1801 SE Hillmoor Drive, Port Saint Lucie, FL 34952 40806 06/13/2006 FL Suite B-107 (Mobile). The Center for Cancer and Blood Disorders, 800 W. Magnolia Avenue, Fort Worth, TX 76104 00L79L 06/13/2006 TX Alliance Imaging—South Coast Medical Cente, r 31872 Pacific Coast Highway, Laguna Beach, CA 92651 TG281B 06/13/2006 CA The Medical Center at Bowling Green, 250 Park Street, Bowling Green, KY 42101 180013 06/13/2006 KY PET/CT Center. Johns Hopkins Bayview Medical Center, 4940 Eastern Avenue, Baltimore, MD 21224 210029 06/13/2006 MD Imaging Department—Nuclear Medicine, University of Michigan, Department of Radiology, 1500 E. Medical Center Drive, Ann Arbor, MI 48109 230046 06/13/2006 MI Box 0028, B1H418 University Hospital. Carmichael Imaging, LLC, 4147 Carmichael Road, Montgomery, AL 36106 51551742 06/13/2006 AL Clearfield Hospital, 809 Turnpike Avenue, Clearfield, PA 16830 390052 06/13/2006 PA Clinical Pet of Hernando, 4003 Mariner Boulevard, Spring Hill, FL 34609 V2683 06/13/2006 FL Booth Radiology, 105 Kings Way, W. Hurffville-Crosskeys Road, Sewell, NJ 08080 39460 06/13/2006 NJ Clinical PET of Zephyrhills, 38044 Daughtery Road, Zephyrhills, FL 33542 E7179B 06/13/2006 FL Radiology & Diagnostic Imaging, 2200 East Parrish Avenue, Owensboro, KY 42303 3641 06/13/2006 KY Building D. Santa Monica Bay Physicians, 12524 W. Washington Boulevard, Los Angeles, CA 90066 W14560 06/13/2006 CA Missouri Baptist Medical Center, 3023 N. Ballas Road, St. Louis, MO 63141 260108 06/13/2006 MO Suite 150, Building D. Radiology Associates of Tallahassee, PA, 1600 Phillips Road, Tallahassee, FL 32308 60 06/13/2006 FL Pacific Imaging—Oakland, 3200 Telegraph Avenue, Oakland, CA 94609 1265480099 06/13/2006 CA Medical Group of North County, 5395 Ruffin Road #202, San Diego, CA 92123 W11609 06/13/2006 CA #202. Somerset Community Hospital, 225 South Center Avenue, Somerset, PA 15501 390039 06/13/2006 PA Elmbrook Memorial Hospital, 19333 W. North Avenue, Brookfield, WI 53045 520170 06/13/2006 WI San Luis Diagnostic Medical Associates, 1100 Monterey Street, San Luis Obispo, CA 93401 W14221 06/13/2006 CA Suite 210. Cancer Care Centers of S.Texas, PA (New Braunfels), 1448 Common Street, New Braunfels, TX 78130 00U40Q 06/13/2006 TX Cancer Care Centers of S.Texas, PA (San Antonio), 8109 Fredericksburg Road, San Antonio, TX 78229 00U40Q 06/13/2006 TX Cancer Care Centers of S.Texas, PA (Kerrville), 694 Hill Country Drive, Kerrville, TX 78028 00U40Q 06/13/2006 TX San Antonio Molecular Imaging SAMI, 9102 Floyd Curl Drive, San Antonio, TX 78240 FTN025 06/13/2006 TX Suite 193. Pacific Medical Imaging and Oncology Center, Inc., 707 South Garfield Avenue, Alhambra, CA 91801 W19267 06/13/2006 CA Suite B-001. Northern IL Cancer Treatment Center, 327 IL Route 2, Dixon, IL 61021 210699 06/13/2006 IL Cancer Care Center, 2210 Green Valley Road, New Albany, IN 47150 243690 06/13/2006 IN Suite 1. Northeast Radiology, 3839 Danbury Road, Brewster, NY 10509 1134118607 06/13/2006 NY New England PET Imaging System, 70 East Street, Methuen, MA1844 M20762 06/13/2006 MA Southeast Texas PET Imaging, 690 North 14th Street, Beaumont, TX 77702 0004CC 06/13/2006 TX Sun City West PET Scan, 14418 W. Meeker Boulevard, Sun City West, AZ 85374 102496 06/13/2006 AZ Suite 105. Butler Memorial Hospital, 911 East Brady Street, Butler, PA 16001 390168 06/13/2006 PA Diagnos, Inc., d.b.a. Diagnos PET/CT Imaging, 2000 North Loop West, Houston, TX 77018 ftnx11 06/13/2006 TX Suite 100. Alliance Imaging—Washington Hospital, 38950 Civic Center Drive, Fremont, CA 94538 ZZZ28890Z 06/13/2006 CA Providence Saint Joseph Hospital, 201 S. Buena Vista Street, Burbank, CA 91505 50235 06/13/2006 CA #125. Alliance Imaging—Centinela Freeman, 333 Prairie Avenue, Inglewood, CA 90301 TG281 06/13/2006 CA Alliance Imaging—Corona Regional Hospital, 800 S. Main Street, Corona, CA 91720 ZZZ23042Z 06/14/2006 CA Alliance Imaging—St. Mary's Regional Medical Center, 235 W. 6th Street, Reno, NV 89503 37860 06/14/2006 NV 235 W. 6th Street. Alliance Imaging—Downey Regional Medical Center, 11500 Brookshire Avenue, Downey, CA 90241 TG490 06/14/2006 CA Alliance Imaging—Visalia Medical Clinic, 5400 W. Hillsdale Drive, Visalia, CA 93291 ZZZ23046Z 06/14/2006 CA Alliance Imaging—Anaheim Memorial Medical Center, 1111 W. La Palma Avenue, Anaheim, CA 92801 TD017C 06/14/2006 CA Anaheim Memorial Medical Center. Glendale Diagnostic Imaging Network Medical Office, 403 South Glendale Avenue, Glendale, CA 91205 W19100 06/14/2006 CA Advanced Imaging at Baybrook, 11 Murray Street, Glens Falls, NY 12801 33554a 06/14/2006 NY Elizabethtown Hematology-Oncology PLC, 1107 Woodland Drive, Elizabethtown, KY 42701 3638 06/14/2006 KY Suite 105. Northern Arizona Radiology, 77 W. Forest Avenue, Suite 101, Flagstaff, AZ 86001 WCGJX 06/14/2006 AZ Suburban Imaging—Coon Rapids, 8990 Springbrook Drive, Suite 140, Coon Rapids, MN 55433 3087 06/14/2006 MN Covenant Medical Center, 200 East Ridgeway Avenue, Waterloo, IA 50702 421264647 06/14/2006 IA Mayo Clinic Rochester, 10 3rd Avenue NW, Rochester, MN 55905 1922074434 06/14/2006 MN Charlton Building. Thousand Oaks Diagnostic Imaging Center, 2180 Lynn Road, Thousand Oaks, CA 91360 TP118 06/14/2006 CA InnerVision Advanced Medical Imaging, 3801 Amelia Avenue, Lafayette, IN 47905 167840 06/14/2006 IN UT-M. D. Anderson Cancer Center—PET Facility, 1220 Holcombe Boulevard, Houston, TX 77030 450076 06/14/2006 TX ACB 6th Floor. Emory University Hospital, 1364 Clifton Road, NE, Atlanta, GA 30322 110010 06/14/2006 GA Rm. E121 Nuclear Medicine/PET. Glendale MRI Institute, 624 S. Central Avenue, Glendale, CA 91204 HW9951 06/14/2006 CA Princeton Radiology, 9 Centre Drive, Jamesburg, NJ 08831 526492 06/14/2006 NJ Caromont Imaging Services, 620 Summit Crossing Place, Gastonia, NC 28054 340032 06/14/2006 NC Suite 106. North Central Imaging, 155 Sonterra Boulevard, Suite 100, San Antonio, TX 78258 00867N 06/14/2006 TX Robert L. B. Tobin Diagnostic Imaging Center, 7979 Wurzbach Drive, Suite U113, San Antonio, TX 78229 00867N 06/14/2006 TX Edwards Comprehensive Cancer Center, 1400 Hal Greer Boulevard, Huntington, WV 25701 510055 06/14/2006 WV Home Hospital GLHS, 2400 South Street, Lafayette, IN 47904 150109 06/14/2006 IN St. Luke's North PET, 153 Brodhead Road, Bethlehem, PA 18017 390049 06/14/2006 PA Alamance Regional Medical Center, 1240 Huffman Mill Road, Burlington, NC 27216-0202 340070 06/14/2006 NC PO Box 202. Verrazano Radiology, 256 Mason Avenue, Staten Island, NY 10305 1698 06/14/2006 NY Total Imaging Sun City, 3862 Sun City Center, Sun City Center, FL 33571 U4840 06/14/2006 FL Ortonville Area Health Services, 450 Eastvold Avenue, Ortonville, MN 56278 241342 06/14/2006 MN Merle West Medical Center, 2865 Daggett Avenue, Klamath Falls, OR 97601 380050 06/14/2006 OR Elite Imaging, LLC, 2845 Aventura Boulevard, Aventura, FL 33180 K3535 06/14/2006 FL Suite 145. St. Mary Centralia, 400 N. Pleasant Avenue, Centralia, IL 62801 140034 06/14/2006 IL North Texas Regional Cancer Center, 3705 W. 15th Street, Plano, TX 75075 00543K 06/14/2006 TX Centegra Health System, 4201 Medical Center Drive, McHenry, IL 60050 140116 06/14/2006 IL Boston Diagnostic Imaging, 398 East Altamonte Drive, Altamonte Springs, FL 32701 77022 06/14/2006 FL William W. Backus Hospital, 326 Washington Street, Norwich, CT 06360 70024 06/14/2006 CT NSMS—Sparta, IL, 4253 Argosy Court, Madison, WI 53714 208196 06/14/2006 WI LaPorte Hospital & Healthcare Services, 1007 Lincolnway, LaPorte, IN 46350 150006 06/14/2006 IN Skagit Valley Hospital, 1415 E. Kincaid Street, Mt.Vernon, WA 98273 500003 06/14/2006 WA Alliance Imaging—Fairfield Hospital, 303 NW 11th Street, Fairfield, IL 62837 213393 06/14/2006 IL Anderson Hospital, 6800 State Route 162, Maryville, IL 62062 212761 06/14/2006 IL Alliance Imaging—Dean, 1313 Fish Hatchery Road, Madison, WI 53715 92170 06/14/2006 WI Alliance Imaging—Research, 2316 E. Meyer Boulevard, Kansas City, MO 64112 9004263A 06/14/2006 MO Alliance Imaging—St. Joseph, 1000 Carondelet Drive, Kansas City, MO 64114 9004263A 06/14/2006 MO Beebe Health Campus, d.b.a. Beebe Medical Center, 18941 John J. Williams Highway, Rehoboth, DE 19971 80007 06/14/2006 DE Medical Outsourcing Services, LLC, 1200 Maple Road, Joliet, IL 60432 211223 06/14/2006 IL Silver Spring Radiology, 10801 Lockwood Drive, Silver Spring, MD 20901 FDX009 06/14/2006 MD STE 170. New England PET of Greater Lowell, 295 Varnum Avenue, Lowell, MA 01854 327080 06/14/2006 MA Stanford University, 900A Blake Wilbur Drive, Stanford, CA 94305 50441 06/14/2006 CA Medical Outsourcing, Services, LLC, 3333 W. DeYoung Street, Marion, IL 62959 211224 06/14/2006 IL Medical Outsourcing Services, LLC, 1700 Clinton Street, Muskegon, MI 49443 230066 06/14/2006 MI Medical Outsourcing Services, LLC, 1001 Bellefontaine Avenue, Lima, OH 45807 MEID02391 06/14/2006 OH Golf Diagnostic Imaging Center, 9680 Golf Road, Des Plaines, IL 60016 378810 06/14/2006 IL Medical Outsourcing Services, LLC, 2816 South Ellis Avenue, Chicago, IL 60616 211222 06/14/2006 IL Medical Outsourcing Services, LLC, 1100 E. Norris Drive, Ottawa, IL 61350 211224 06/14/2006 IL Medical Outsourcing Services, LLC, 111 E. Spring Street, Streator, IL 61364 211224 06/14/2006 IL Mansfield Imaging Center, 536 S. Trimble Road, Mansfield, OH 44906 MAD10921 06/14/2006 OH Suite A. Manhattan Diagnostic Radiology, 400 East 66th Street, New York, NY 10021 W23211 06/14/2006 NY Riverside Walter Reed Hospital, 7519 Hospital Drive, Gloucester, VA 23061 490130 06/14/2006 VA Good Shepherd Hospital, 450 West Highway 22, Barrington, IL 60010 140291 06/14/2006 IL Alliance Imaging—Presbyterian Intercomm Hospital, 12401 Washington Boulevard, Whittier, CA 90602 TG281A 06/14/2006 CA Presbyterian Intercommunity Hospital. Altru Hospital, 1200 S. Columbia Road, Grand Forks, ND 58201 350019 06/14/2006 ND Mid American Imaging—Union Hospital, 659 Boulevard Street, Dover, OH 44622 ID00805 06/14/2006 OH Gundersen Clinic, 1900 South Avenue, Lacrosse, WI 54601 34217 06/14/2006 WI University of Minnesota Medical Center, Fairview, 500 Harvard Street, SE, Box 292, Minneapolis, MN 55455 C02390 06/14/2006 MN The Christ Hospital, 2139 Auburn Avenue, Cincinnati, OH 45219 360163 06/14/2006 OH West Michigan Cancer Center, 200 N. Park Street, Kalamazoo, MI 49007 0N66660 06/14/2006 MI Cyrus Diagnostic Imaging, Inc., 165 Waymont Court, Lake Mary, FL 32746 40586 06/14/2006 FL Cancer Centers of Florida, 1561 West Fairbanks Avenue, Winter Park, FL 32789 K1833 06/14/2006 FL Cedars-Sinai Medical Center, 8700 Beverly Boulevard, Adler-Nail PET Center, Los Angeles, CA 90048 951644600 06/14/2006 CA S. Mark Taper Foundation Imaging Center. Cancer Centers of Florida, 52 West Gore Street, Orlando, FL 32806 K1833 06/14/2006 FL Cancer Centers of Florida, 1111 Blackwood Avenue, Ocoee, FL 34761 K1833 06/14/2006 FL Mt. Clemens Regional Medical Center, 1000 Harrington Street, Mt. Clemens, MI 48043 230227 06/14/2006 MI Truxtun Radiology Medical Group, LP, 1818 16th Street, Bakersfield, CA 93301 ZZZ25213Z 06/14/2006 CA Medical Outsourcing Services, LLC, 1515 North Madison Avenue, Anderson, IN 46011 223260 06/14/2006 IN Medical Outsourcing Services, LLC, 1215 Franciscan Drive, Litchfield, IL 62056 211224 06/14/2006 IL Piedmont Medical Center, 1968 Peachtree Road, NW, Atlanta, GA 30305 110083 06/14/2006 GA Medical Outsourcing Services, LLC, 1400 West Park Street, Urbana, IL 61801 211224 06/14/2006 IL Central Indiana PET, LLC, 8301 Harcourt Road, Suite 100, Indianapolis, IN 46260 201930 06/14/2006 IN Medical Outsourcing Services, LLC, 812 North Logan Avenue, Danville, IL 61832 211224 06/14/2006 IL Queens Medical Imaging, PC, 69-15 Austin Street, Forest Hills, NY 11375 1023011285 06/14/2006 NY NYOH PET/CT Imaging, 43 New Scotland Avenue, Albany, NY 12208 56917A 06/14/2006 NY Conroe Regional Medical Center, 504 Medical Center Boulevard, Conroe, TX 77304 450222 06/14/2006 TX Northeast Georgia Health System, Inc., Northeast Georgia Medical Center, 743 Spring Street, Gainesville, GA 30501 110029 06/14/2006 GA Texas Oncology, PA—Mckinney, 4510 Medical Center Drive, Mckinney, TX 75069 00543K 06/14/2006 TX #215. Medical Outsourcing Services, LLC, 7150 Clearwater Drive, Indianapolis, IN 46256 223260 06/14/2006 IN Medical Outsourcing Services, LLC, 1402 East County Line Road, Indianapolis, IN 46227 223260 06/14/2006 IN Texas Cancer Center—Sherman, 2800 Highway 75 North, Sherman, TX 75090 00543K 06/14/2006 TX Medical Outsourcing Services, LLC, 120 Ralston Avenue, Defiance, OH 43512 MEID02391 06/14/2006 OH Medical Outsourcing Services, LLC, 2400 N. Rockton Avenue, Rockford, IL 61103 211224 06/14/2006 IL Arlington Cancer Center, 906 W. Randol Mill Road, Arlington, TX 76012 00LK20 06/14/2006 TX Jupiter Medical Center, 2055 Military Trail, Jupiter, FL 33458 100253 06/14/2006 FL Cheyenne Radiology Group and MRI, PC, 2003 Bluegrass Circle, Cheyenne, WY 82009 W309142 06/14/2006 WY Hunterdon Imaging, PA, 2100 Wescott Drive, MRI, Suite, Flemington, NJ 08822 714119 06/14/2006 NJ Medical Outsourcing Services, LLC, 200 Berteau Avenue, Elmhurst, IL 60126 211223 06/14/2006 IL Magnolia Regional Center, 611 Alcorn Drive, Corinth, MS 38834 250009 06/14/2006 MS Monroe Clinic, 515 22nd Avenue, Monroe, WI 53566 520028 06/14/2006 WI Jupiter Hematology-Oncology Associates, 345 Jupiter Lakes Boulevard, Jupiter, FL 33458 34922 06/14/2006 FL Ste.100. Southwest Regional Cancer Center, 901 West 38th Street, Austin, TX 78705 0080BY 06/14/2006 TX Positron Imaging Of Austin, 6101 Balcones Drive, Austin, TX 78731 00538K 06/14/2006 TX Southern Ocean County Hospital, 1140 Route 72 West, Manahawkin, NJ 08050 310113 06/14/2006 NJ Radiology. Medical Outsourcing Services, LLC, 9830 S. Ridgeland Road, Chicago Ridge, IL 60145 211222 06/14/2006 IL Medical Outsourcing Services, LLC, 430 West Votaw Street, Portland, IN 47374 223260 06/14/2006 IN Saint Agnes Medical Center, 1303 E. Herndon Avenue, Fresno, CA 93720 50093 06/14/2006 CA Central Physicians Imaging, 100 Southland Drive, Lexington, KY 40503 9375001 06/14/2006 KY Suite B. NEA Medical Center, 3024 Stadium Boulevard, Jonesboro, AR 72401 1386699353 06/14/2006 AR Northgate Medical Imaging, LLC, 807 Northgate Boulevard, New Albany, IN 47150 1205894235 06/14/2006 IN Ball Memorial Hospital, 2401 University Avenue, Muncie, IN 47303 150089 06/14/2006 IN The MRI Center, 5200 Harroun Road, Sylvania, OH 43560 360074 06/14/2006 OH Flower Hospital. St. Joseph Regional Health Center, 2801 Franciscan Drive, Bryan, TX 77802 450011 06/14/2006 TX Steinberg Diagnostic (SDMI), 2850 Siena Heights, Henderson, NV 89052 WCHCC 06/14/2006 NV Raritan Bay Medical Center, 1 Hospital Plaza, Old Bridge, NJ 08857 310039 06/14/2006 NJ MRI Center—St. Anne Mercy Hospital, 3404 W. Sylvania Avenue, Toledo, OH 43623 360262 06/14/2006 OH MRI Center—St. Charles Mercy Hospital, 2600 Navarre Avenue, Oregon, OH 43616 360081 06/14/2006 OH MRI Center—St. Luke's Hospital, 2901 Monclova Road, Maumee, OH 43537 360090 06/14/2006 OH MRI Center—St. Vincent Medical Center, 2213 Cherry Street, Toledo, OH 43608 360112 06/14/2006 OH MRI Center—Toledo Hospital, 2142 N. Cove Boulevard, Toledo, OH 43606 360068 06/14/2006 OH McAlester Regional Health Center, One Clark Bass Boulevard, McAlester, OK 74501 370034 06/14/2006 OK Express Imaging Center, Ltd., 1987 West Fourth Street, Mansfield, OH 44906 9299151 06/14/2006 OH Suite A. Mercy Regional Medical Center, 375 East Park Avenue, Durango, CO 81301 60013 06/14/2006 CO Texas Oncology—Longview Cancer Center PET, 1300 N. Fourth Street, Longviews, TX 75601 00T35E 06/14/2006 TX UNC Hospitals, 101 Manning Drive, Chapel Hill, NC 27514 3400610 06/14/2006 NC PET Department. Basement W/C Hospital. DeKalb Medical Center—Diagnostic Imaging Center, 2701 North Decatur Road, Decatur, GA 30033 110076 06/14/2006 GA Long Island Pet Imaging, 6 Ohio Drive, Lake Success, NY 11042 W4921 06/14/2006 NY Suite 101. Vanderbilt University Medical Center, 1161 21st Avenue South, Nashville, TN 37232 3284867 06/14/2006 TN Building 1251 RRB. Medical Outsourcing Services, LLC, 1800 E. Lakeshore Drive Decatur, IL 62521 211224 06/14/2006 IL New York PET and CTA Imaging Center, 7404 5th Avenue, Brooklyn, NY 11209 1083680003 06/14/2006 NY Mercy Medical Center—North Iowa, 1000 4th Street SW, Mason City, IA 50401 160064 06/14/2006 IA Lawrence and Memorial Hospital, 365 Motauk Avenue, New London, CT 06320 70007 06/14/2006 CT Superior Medical Diagnostics II, LLC, 235 Franklin Avenue, Nutley, NJ 07110 68423 06/14/2006 NJ Oncology Specialists, S.C., 7900 N. Milwaukee Avenue, Niles, IL 60714 587940 06/14/2006 IL Suite 16. Hahnemann University Hospital, Broad & Vine, MS300, Philadelphia, PA 19102 390290 06/14/2006 PA Shrewsbury Diagnostic Imaging, LLC, 1131 Broad Street, Shrewsbury, NJ 07702 24021 06/14/2006 NJ Suite 110. Medical Outsourcing Services, LLC, 500 West Court Street, Kankakee, IL 60901 211224 06/14/2006 IL Forsyth Medical Center, 3333 Silas Creek Parkway, Winston Salem, NC 27103 3400014 06/14/2006 NC Medical Outsourcing Services, LLC, 500 John Deere Road, Moline, IL 61265 211224 06/14/2006 IL Medical Outsourcing Services, LLC, 836 W. Wellington Avenue, Chicago, IL 60657 211222 06/14/2006 IL Medical Outsourcing Services, LLC, 1600 West Walnut, Jacksonville, IL 62650 211224 06/14/2006 IL Medical Outsourcing Services, LLC, 1600 23rd Street, Bedford, IN 47471 223260 06/14/2006 IN Medical Outsourcing Services, LLC, 1500 North Ritter Avenue, Indianapolis, IN 46219 223260 06/14/2006 IN Medical Outsourcing Services, LLC, 1221 N. Highland, Aurora, IL 60506 211223 06/14/2006 IL Medical Outsourcing Services, LLC, 1000 Lincoln Health Center Drive, Mattoon, IL 61938 211224 06/14/2006 IL Salinas Valley Memorial Healthcare System, 450 E. Romie Lane, Salinas, CA 93901 50334 06/14/2006 CA Bridgeport Hospital, 267 Grant Street, Bridgeport, CT 06610 70010 06/14/2006 CT MRIGP, Inc., d.b.a. Advanced Medical Imaging Diamond H., 2490 W 26th Avenue, Suite 20A, Denver, CO 80211 H8808 06/14/2006 CO RCHO PET Imaging, 5120 Belfort Boulevard, Suite 130, Jacksonville, FL 32256 40259 06/14/2006 FL Presbyterian Hospital, 200 Hawthorne Lane, Charlotte, NC 28204 560554230 06/14/2006 NC Eisenhower Imaging Center, 39000 Bob Hope Drive, Rancho Mirage, CA 92210 ZZZ91572Z 06/14/2006 CA Lower Level Lucy Curci Cancer Center. Mississippi Baptist Medical Center, 501 Marshall Street, Jackson, MS 39202 250102 06/14/2006 MS Texas Oncology—South Texas Cancer Center, 2121 Pease Street, Suite 101, Harlingen, TX 78550 14041756 06/14/2006 TX Texas Oncology—South Texas Cancer Center. Valley Radiologists, Ltd.—Paseo II Office, 5605 W. Eugie Avenue, Suite 110, Glendale, AZ 85304 WCFHS 06/14/2006 AZ Good Samaritan Hospital, 400 15th Avenue SE, Puyallup, WA 98372 500079 06/14/2006 WA St. John's Mercy Hospital, 851 5th Street, Washington, MO 63090 260052 06/14/2006 MO Memorial Hermann The Woodlands OPID, 9200 Pinecroft Drive, Suite 100, The Woodlands, TX 77380 741152597 07/14/2006 TX St. Luke's Hospital, 232 South Wood's Mill Road, Chesterfield, MO 63017 260179 07/14/2006 MO Lake Vista Cancer Center, 2790 Lake Vista Drive, Lewisville, TX 75067 00543K 07/14/2006 TX Palms Imaging Medical Group, Inc., 1901 Outlet Center Drive, Oxnard, CA 93036 W19564 07/14/2006 CA Houston Medical Imaging, LLC, 3310 Richmond Avenue, Houston, TX 77006 00137K 07/14/2006 TX Alliance Imaging—West Anaheim Medical Center, 3033 W. Orange Avenue, Anaheim, CA 92804 TD017 07/14/2006 CA Winthrop PET Imaging Center, 222 Station Plaza North, Suite 140, Mineola, NY 11501 330167 07/14/2006 NY Greenville Hospital System, University Medical Center, 701 Grove Road, Greenville, SC 29605 420078 07/14/2006 SC High Field Open MRI, 1895 Jefferson Road, Rices Landing, PA 15357 7885 07/14/2006 PA PET/CT Center at St. Anthony's POB, 1201 5th Avenue North, St. Petersburg, FL 33705 E5753 07/14/2006 FL Suite 100. Texas Oncology—Deke Slayton Cancer Center, 501 Medical Center, Webster, TX 77598 00t40e 07/14/2006 TX Invision North Florida Outpatient Imaging Center, 6605 NW 9th Boulevard, Gainesville, FL 32609 E4639 07/14/2006 FL Memorial Hospital of Union County, 500 London Avenue, Marysville, OH 43040 360092 07/14/2006 OH Texas Oncology/South Texas Cancer Center—McAllen, 1901 S. 2nd Street, McAllen, TX 78503 00N39J 07/14/2006 TX Baylor Medical Center at Irving, 1901 North MacArthur Boulevard, Irving, TX 75061 450079 07/14/2006 TX Providence Park Hospital, 47601 Grand River Avenue, Novi, MI 48374 230019 07/14/2006 MI Texas Oncology—Abilene, 1957 Antilley Road, Abilene, TX 79606 140414748 07/14/2006 TX St. Anthony Hospital, 1000 North Lee Street, Oklahoma City, OK 73101 370037 07/14/2006 OK Rice Memorial Hospital, 301 Becker Avenue SW, Willmar, MN 56201 240088 07/14/2006 MN LDS Hospital Nuclear Medicine, 8th Avenue & C Street, Salt Lake City, UT 84143 460010 07/14/2006 UT RMG First & Laurel Imaging Center, 2466 First Avenue, San Diego, CA 92101 W14057 07/14/2006 CA RMG Gardenview Imaging Center, 1200 Gardenview Road, Encinitas, CA 92024 W14057F 07/14/2006 CA Suite 110. Decatur County Memorial Hospital, 720 North Lincoln Street, Greensburg, IN 47240 150062 07/14/2006 IN Midland Imaging Center, 5001 Andrews Highway, Midland, TX 79703 00U75H 07/14/2006 TX Advanced Imaging, LLC, 3433 NW 56th C-10, Oklahoma City, OK 73112 400522379 07/14/2006 OK University of Iowa Hospitals and Clinics, 200 Hawkins Drive, Iowa City, IA 52242 160058 07/14/2006 IA AZ Oncology Associates PET/CT & CT Imaging Center, 2070 W. Rudasill Road, Tucson, AZ 85704 25291 07/14/2006 AZ Suite 110. Medical Diagnostic Imaging, 14 Raymond Avenue, Poughkeepsie, NY 12603 EEN841 07/14/2006 NY Shore Memorial Hospital, 10085 William F. Bernart Circle, Nassawadox, VA 23413 540560500 07/14/2006 VA Deaconess Hospital, 600 Mary Street, Evansville, IN 47747 150082 07/14/2006 IN Great Neck Imaging, PC, 907 Northern Boulevard, Great Neck, NY 11021 1487646311 07/14/2006 NY FMH Rose Hill, 1562 Opossumtown Pike, Frederick, MD 21702 KP72 07/14/2006 MD Oakwood Annapolis Hospital, 33155 Annapolis Road, Wayne, MI 48184 230142 07/14/2006 MI The Regional Cancer Center, 2500 West 12th Street, Erie, PA 16505 140052 07/14/2006 PA Meritcare Hospital, 801 North Broadway, Fargo, ND 58122 350011 07/14/2006 ND Community Hospitals and Wellness Centers, 433 W. High Street, Bryan, OH 43506 360121 07/14/2006 OH Sacred Heart Hospital, 900 W. Clairemont Avenue, Eau Claire, WI 54701 520013 07/14/2006 WI Via Radiology—Meridian Pavilion, 11011 Meridian Avenue North #101, Seattle, WA 98133 8859612 07/14/2006 WA Medical Outsourcing Services, LLC, 2200 Market Street, Charlestown, IN 47111 223260 07/14/2006 IN Allegheny General Hospital, 320 East North Avenue, Pittsburgh, PA 15232 60503 07/14/2006 PA Division of Nuclear Medicine. Texas Oncology—12th Avenue, 1001 W. 12th Avenue, Fort Worth, TX 76104 00R66C 07/14/2006 TX Southwest Fort Worth Cancer Center, 6500 Harris Parkway, Fort Worth, TX 76132 00R66C 07/14/2006 TX St. Rita's Medical Center, 730 W. Market Street, Lima, OH 45801 360066 07/14/2006 OH New Mexico Oncology Hematology Consultants, Ltd., 4901 Lang Avenue NE, Albuquerque, NM 87109 850367056 07/14/2006 NM Emory Eastside Medical Center, 545 Old Norcross Road, Lawrenceville, GA 30045 110192 07/14/2006 GA Suite 200. Riverside Regional Medical Center, 500 J. Clyde Morris Boulevard, Newport News, VA 23601 490052 07/14/2006 VA Connecticut Oncology & Hematology, 220 Kennedy Drive, Torrington, CT 06790 C00633 07/14/2006 CT Chilton Memorial Hospital, 97 West Parkway, Pompton Plains, NJ 07444 310017 07/14/2006 NJ Riverside Diagnostic Center Williamsburg, 120 Kings Way, Williamsburg, VA 23188 490052 07/14/2006 VA Lawrence County MRI & Diagnostic Imaging Center, 2526 Wilmington Road, New Castle, PA 16105 68617 07/14/2006 PA Joint Township District Memorial Hospital, 200 St. Clair Street, Saint Marys, OH 45885 360032 07/14/2005 OH Radiation Therapy Regional Centers, 3680 Broadway, Fort Myers, FL 33901 77215 07/14/2006 FL Graduate Hospital, 1800 Lombard Street, Philadelphia, PA 19146 390285 07/14/2006 PA One Graduate Hospital. Columbia Diagnostic Center, 1111 Paulison Avenue, Clifton, NJ 07015 94729 07/14/2006 NJ The Nebraska Medical Center, 4250 Dewey Avenue, Omaha, NE 68113 280013 07/14/2006 NE Memorial Hermann Memorial City OPID, 925 Gessner Road, Houston, TX 77024 741152597 07/14/2006 TX Clifton Springs Hospital and Clinic, 2 Coulter Road, Clifton Springs, NY 14432 330265 07/14/2006 NY Monongalia General Hospital, 1200 J. D. Anderson Drive, Morgantown, WV 26505 510024 07/14/2006 WV Monongalia General Hospital. Providence Portland Medical Center, 4805 NE Glisan Street, Portland, OR 97213 380061 07/14/2006 OR Highfield Open MRI, Inc., 995 GreenTree Road, Pittsburgh, PA 15220 7885 07/14/2006 PA Providence St. Vincent Medical Center, 9205 SW Barnes Road, Portland, OR 97225 380004 07/14/2006 OR Conway Regional Imaging Center, 2120 Robinson Avenue, Conway, AR 72034 40029 07/14/2006 AR Martin Memorial Medical Center, 300 Hospital Avenue, Stuart, FL 34994 100044 07/14/2006 FL Northwest Medical Foundation of Tillamook, 1000 Third Street, Tillamook, OR 97141 381317 07/14/2006 OR Tillamook County General Hospital. O'Connor Hospital, 2105 Forest Avenue, San Jose, CA 95128-1471 50153 07/14/2006 CA Midtown Imaging, LLC—Wellington, 440 N. State Road 7, Wellington, FL 33411 E9133 07/14/2006 FL Midtown Imaging, LLC—Jupiter, 345 Jupiter Lakes Boulevard, Jupiter, FL 33458 E9133 07/14/2006 FL Suite 100. MMI/Mid Coast Hospital, 51 US Route 1, Scarborough, ME 04074 327079 07/14/2006 ME Suite O. Molecular Imaging Institute, 5349 Commerce Boulevard, Crown Point, IN 46307 192870 07/14/2006 IN RCOA Imaging Services, 11937 US Highway 271, Tyler, TX 75708 FTN022 07/14/2006 TX MMI/Maine Medical Center, 51 US Route 1, Scarborough, ME 4074 327079 07/14/2006 ME Suite O. Radiology, Ltd., 4640 East Camp Lowell Drive, Tucson, AZ 85712 WCBBM 07/14/2006 AZ Intermed Oncology Associates, S.C., 6701 159th Street, Tinley Park, IL 60477 610860 07/14/2006 IL Lakes Radiology, 450 Canisteo Street, Hornell, NY 14843 1710937727 07/14/2006 NY Opelousas PET/CT Imaging Center, 3975 I-49 South Service Road, Suite 100, Opelousas, LA 70570 5DA11 07/14/2006 LA Florida Cancer Institute—BRK, 7154 Medical Center Drive, Spring Hill, FL 34608 1427017326 08/07/2006 FL Capital Health System, 446 Belleview Avenue, Trenton, NJ 08618 310044 08/07/2006 NJ Hudson Valley Diagnostic Imaging, PLLC, 575 Hudson Valley Avenue, New Windsor, NY 12553 WBH241 08/07/2006 NY St Joseph's Hospital, 3200 Pleasant Valley Road, West Bend, WI 53095 520063 08/07/2006 WI Atlantic Medical Imaging, 30 East Maryland Avenue, Somers Point, NJ 08244 101024 08/07/2006 NJ Providence Imaging Center, 3340 Providence Drive, Anchorage, AK 99508 2085R0202X 08/07/2006 AK Rochester Radiology Associates, PC, 1277 Portland Avenue, Rochester, NY 14621 199726 08/07/2006 NY Melbourne Internal Medicine Associates, 1132 South Hickory Street, Melbourne, FL 32901 77167 08/07/2006 FL Highline Imaging, LLC, 275 SW 160th Street, Seattle, WA 98166 8801784 08/07/2006 WA Tyler PET, 415 South Fleishel Avenue, Tyler, TX 75702 752131429 08/07/2006 TX Lake City Medical Center, 340 NW Commerce Drive, Lake City, FL 32055 100156 08/07/2006 FL Blount Memorial Hospital, 907 East Lamar Alexander Boulevard, Maryville, TN 37804 440011 08/07/2006 TN Texas Cancer Center Mesquite, 4700 North Galloway, Mesquite, TX 75150 R339 08/07/2006 TX Rutland Regional Medical Center: Diagnostic Imaging, 160 Allen Street, Rutland, VT 05701 470005 08/07/2006 VT MDMED, Inc., 155 Calle Portal, Suite 700, Sierra Vista, AZ 85635 Z68496 08/07/2006 AZ Atlantic Medical Imaging Wall Township, 2399 North Highway 34, Manasquan, NJ 08736 101024 08/07/2006 NJ Ramshorn Executive Centre Bldg B. Newport Imaging Center, 455 Old Newport Road, Suite 101, Newport Beach, CA 92660 W10829 08/07/2006 CA Cancer Care and Hematology Specialists (CCHSC), 8915 West Golf Road, Niles, IL 60714-05825 355030 08/07/2006 IL Hematology Oncology Associates of Illinois (HOAI), 715 West North Avenue, Melrose Park, IL 60160 218860 08/07/2006 IL Princeton Community Hospital, 122 12th Street Ext, Princeton, WV 24740 510046 08/07/2006 WV PO Box 1369. TRICAT, LLC at Edison, 3830 Park Avenue, Edison, NJ 08820 27193 08/07/2006 NJ Suite 102. Olathe Medical Center, 20333 W. 151st Street, Olathe, KS 66061 170049 08/07/2006 KS St. Joseph Hospital, 1140 West La Veta Avenue, Orange, CA 92868 50069 08/07/2006 CA 2nd Floor Nuclear Medicine. Baptist Health Medical Center, 9601 I630, Exit 7, Little Rock, AR 72205-7299 40114 08/07/2006 AR Florida Cancer Specialists, 3840 Broadway, Fort Myers, FL 33901 1225064520 08/07/2006 FL Pacca PET Imaging, 5210 Belfort Road, Suite 130, Jacksonville, FL 32256 37572 08/07/2006 FL National PET Scan Palm Beach, LLC, 16110 Jog Road, Delray Beach, FL 33484 1164452405 08/07/2006 FL Suite 200. Central Memphis Regional PET Imaging Center, LLC, 1388 Madison Avenue, Memphis, TN 38104 1295719110 08/07/2006 TN Johnston Memorial Hospital, 351 Court Street NE, Abingdon, VA 24210 490053 08/07/2006 VA Lenox Hill Hospital, 100 East 77th Street, New York, NY 10021 131624070 08/07/2006 NY Mercy Medical Center, 411 Laurel Street, Suite 2310, Des Moines, IA 50314 160083 08/07/2006 IA New Orleans Regional PET Center, LLC, 3434 Prytania Street, Suite 120, New Orleans, LA 70115 1538143474 08/07/2006 LA Indiana Regional Medical Center PET Imaging, 835 Hospital Road, Indiana, PA 15701 390173 08/07/2006 PA PO Box 788. Mid American—Defiance Clinic, 1400 E. Second Street, Defiance, OH 43512 ID00809 08/07/2006 OH Total Imaging Robertson, 737 West Brandon Boulevard, Brandon, FL 33511 k7282 08/07/2006 FL New Tampa Imaging Center, 14302 N. Bruce B. Downs Boulevard, Tampa, FL 33613 k57209 08/07/2006 FL Summit Imaging, 12037 Cortez Boulevard, Brooksville, FL 34613 40986 08/08/2006 FL University of NM Cancer Research & Treatment Center, 900 Caminodey Salud NE, Albuquerque, NM 87131 400521103 08/08/2006 NM Alliance Imaging—Los Alamitos Med Center, 3751 Katella Avenue, Los Alamitos, CA 90720 TD017 08/08/2006 CA NYU Clinical Cancer Center, Diagnostic Imaging, 160 E. 34th Street, New York, NY 10016 W1L361 08/08/2006 NY 2nd Floor. Margaret Mary Community Hospital, 321 Mitchell Avenue, Batesville, IN 47006 151329 08/08/2006 IN Quantum PET—Apple Hill, 37 Monument Road, York, PA 17403 40635 08/08/2006 PA Memorial Hospital, 1204 N. Mound Street, Nacogdoches, TX 75961 450508 08/08/2006 TX BMH—DeSoto, 7601 Southcrest Parkway, Southaven, MS 38671 250141 08/08/2006 MS Riverside Medical Center, 300 Bourbonnais Campus, Bourbonnais, IL 60914 140186 08/08/2006 IL Riverside Medical Center. UCSD Center for Molecular Imaging, 11388 Sorrento Valley Road, Suite 100, San Diego, CA 92121 TG302 08/08/2006 CA Imaging Partners at Valley, LLC, 400 South 43rd Street, Renton, WA 98055 AB38657 08/08/2006 WA Olympic Building. El Paso Cancer Treatment Center, 7848 Gateway East Boulevard, El Paso, TX 79915 00543K 08/08/2006 TX Desert Radiologists, 3930 S. Eastern Avenue, Las Vegas, NV 89119 VWCCBT 08/08/2006 NV Saint Joseph Hospital, 2900 North Lake Shore Drive, Chicago, IL 60068 140224 08/08/2006 IL Midstate Medical Center, 435 Lewis Avenue, Meriden, CT 06451 60646715 08/08/2006 CT Brookville Hospital, 100 Hospital Road, Brookville, PA 15825 391312 08/08/2006 PA Suntree Diagnostic Center, 6300 N. Wickham Road, Suite 101, Melbourne, FL 32940 701 08/08/2006 FL Virginia Mason Medical Center, 1100 Ninth Avenue, Seattle, WA 98101 500005 08/08/2006 WA Van Wert County Hospital, 1250 South Washington Street, Van Wert, OH 45891 360071 08/08/2006 OH Manhasset Diagnostic Imaging, PC, 1350 Northern Boulevard, 2nd Floor, Manhasset, NY 11030 W14841 08/08/2006 NY Southern New Mexico Cancer Center, 150 Road Runner Parkway, Las Cruces, NM 88011 752131429 08/08/2006 NM Davis Memorial Hospital, Gorman Avenue and Reed Street, Elkins, WV 26241 510030 08/08/2006 WV Gorman Avenue. Advocate Good Samaritan Hospital, 3815 Highland Avenue, Downers Grove, IL 60515 140288 08/08/2006 IL Benefis Healthcare, 1101 26th Street South, Great Falls, MT 59405 270012 08/08/2006 MT Fort Walton Beach Medical Center, 1032 Mar Walt Drive, Fort Walton Beach, FL 32547 100223 08/08/2006 FL Blessing Hospital, PO Box #7005, Quincy, IL 62305 140015 08/08/2006 IL Alliance Imaging—Allen County Hospital, 101 South 1st Street, Iola, KS 53808 130656 08/08/2006 KS Florida Cancer Institute—NPR, 8763 River Crossing Boulevard, New Port Richey, FL 34655 1427017326 08/08/2006 FL Kimball Medical Center, 600 River Avenue, Lakewood, NJ 08701 315084 08/08/2006 NJ Radiology Imaging Associates at Heritage, 8926 Woodyard Road, Clinton, MD 20735 521454775 08/08/2006 MD Suite 502. Immanuel Medical Center, 6901 North 72nd Street, Omaha, NE 68122 280081 08/08/2006 NE North Fork Radiology, 1333 Roanoke Avenue, Riverhead, NY 11901 w11401 08/08/2006 NY South County PET Imaging, LLC, 10010 Kennerly Road, St. Louis, MO 63128 93053 08/08/2006 MO Carolinas Hospital System, 805 Pamplico Highway, Florence, SC 29505 621587267 08/08/2006 SC Radiology Associates of San Luis Obispo, 522 E. Plaza Drive, Santa Maria, CA 93454 GR0009774 08/08/2006 CA Florida Cancer Specialists—Port Charlotte, 22395 Edgewater Drive, Port Charlotte, FL 33980 1225064520 08/08/2006 FL Florida Cancer Specialists—Venice, 901 South Tamiami Trail, Venice, FL 34285 1225064520 08/08/2006 FL Florida Cancer Specialists—Bradenton, 6001 21st Avenue West, Bradenton, FL 34209 1225064520 08/08/2006 FL Nebraska Methodist Hospital, 8303 Dodge Street, Omaha, NE 68114 280040 08/08/2006 NE PET/CT Center of Richardson, 399 Melrose Drive, Richardson, TX 75080 1740207539 08/08/2006 TX Suite A. Molecular Imaging at Sequoia Imaging Center, 4949 W. Cypress Avenue, Visalia, CA 93277 ZZZ27463Z 08/08/2006 CA Central Jersey Radiologists, 2128 Kings Highway, Oakhurst, NJ 07755 527995 08/08/2006 NJ Claxton-Hepburn Medical Center, 214 King Street, Ogdensburg, NY 13669 330211 08/08/2006 NY Memorial Hermann Southeast, 11800 Astoria Boulevard, Houston, TX 77089 741152597 08/08/2006 TX NSMS—Pine Bluff, AR, 4253 Argosy Court, Madison, WI 53714 5f168 08/08/2006 WI Yuma Regional Medical Center, 2400 S. Avenue A, Yuma, AZ 85364 866007596 08/08/2006 AZ Carle Clinic, 1702 S. Mattis Avenue, Champagne, IL 61820 371188284 08/08/2006 IL North Shore—LIJ Center for Advanced Medicine, 450 Lakeville Road, Lake Success, NY 11042 330106 08/08/2006 NY North Shore—LIJ Center for Advanced Medicine Diagnostic Imaging Center. McAlester Diagnostic Imaging, 10 South Third Street, McAlester, OK 74501 1760411540 08/08/2006 OK Suite 100. California Imaging Institute, 1867 E. Fir Avenue, Fresno, CA 93720 ZZZ03565Z 08/08/2006 CA Bon Secours Memorial Regional Medical Center, 8260 Atlee Road, Mechanicsville, VA 23116 541744931 08/08/2006 VA University of Maryland Medical Center, 22 S. Greene Street Gudelksy 2nd Floor, Baltimore, MD 21201 210002 08/08/2006 MD Division of Nuclear Medicine. Bixby Medical Center, 818 Riverside Avenue, Adrian, MI 49221 230005 08/08/2006 MI Kern Radiology Medical Group, 2301 Bahamas Drive, Bakersfield, CA 93309 1720023997 08/08/2006 CA Bon Secours St. Francis Medical Center, 13710 St. Francis Boulevard, Midlothian, VA 23114 311716973 08/08/2006 VA MMI/Maine General Waterville, 51 US Route 1, Scarborough, ME 04074 327079 08/08/2006 ME Suite O. Mount Adams Imaging Center, 3911 Castlevale Road, Yakimaw, WA 98902 8857843 08/08/2006 WA Carilion Roanoke Memorial Hospital, 2001 Crystal Spring Avenue, Roanoke, VA 24014 490024 08/08/2006 VA Seton Medical Center; Nuclear Medicine Dept., 1900 Sullivan Avenue, Daly City, CA 94015-2229 50289 08/08/2006 CA Arnett Imaging Center, 2403 Loy Drive, Lafayette, IN 47909 224390 08/08/2006 IN Advanced Diagnostic Imaging, PC, 1120 Professional Boulevard, Evansville, IN 47630 639970 08/08/2006 IN Queen of Peace Hospital, 301 Second Street NE, New Prague, MN 56071 241361 08/08/2006 MN Agnesian Health Care, 430 E. Division Street, Fond du Lac, WI 54935 520088 08/08/2006 WI ACMH Hospital, One Nolte Drive, Kittanning, PA 16201 390163 08/08/2006 PA Wilshire Oncology Medical Group, Inc., 1280 Corona Pointe Court, Corona, CA 92879 zzz19568z 08/08/2006 CA Suite 112. United Radiology—Laurel, 14201 Laurel Park Drive, Laurel, MD 20707 2.01558E+11 08/08/2006 MD Suite 208. Bay Area Medical Center, 3100 Shore Drive, Marinette, WI 54143 520113 08/08/2006 WI Penn State Milton S. Hershey Medical Center, 500 University Drive, Hershey, PA 17033 251854772 08/08/2006 PA HG380. Delta St. Joseph's MRI, LLC, 1617 N. California Street, Stockton, CA 95204 ZZZ19725Z 08/08/2006 CA Suites 1A and 1B. United Radiology: Bowie, 16701 Melford Boulevard, Bowie, MD 20715 2.01558E+11 08/08/2006 MD United Radiology Gaithersburg, 702 Russell Avenue, Gaithersburg, MD 20877 2.01558E+11 08/08/2006 MD United Radiology Olney, 18120 Hillcrest Drive, Olney, MD 20832 2.01558E+11 08/08/2006 MD Suite A. FCS/Axcess Diagnosis/Sarasota, 600 N. Cattleman Road, Sarasota, FL 34232 1225064520 08/08/2006 FL NSMS—Greenville, IL, 4253 Argosy Court, Madison, WI 53714 208196 08/08/2006 WI FCS/Axcess Diagnosis/Venice, 842 Sunset Lake Boulevard, Venice, FL 34292 1225064520 08/08/2006 FL Suite #301. Leading Edge Radiation, 8715 5th Avenue, Brooklyn, NY 11209 WEM111 09/05/2006 NY Rena Tarbet Cancer Center, 4201 Medical Center Drive, Suite 180, McKinney, TX 75069 oow753 09/05/2006 TX McLaughlin & Marte, M.D, LLP, 3850 Tampa Road, Suite 202, Palm Harbor, FL 34684 1003862079 09/05/2006 FL BryanLGH Medical Center, 2300 South 16th Street, Lincoln, NE 68502 280003 09/05/2006 NE Freehold MR Associates, 691 West Main Street, Freehold, NJ 07728 405856 09/05/2006 NJ Franciscan Skemp Healthcare, 700 West Avenue South, La Crosse, WI 54601 520004 09/05/2006 WI Teton Radiology, 2001 S. Woodruff, Suite 17, Idaho Falls, ID 83404 1371462 09/05/2006 ID Fletcher Allen Health Care, Mobile Pad, 790 College Parkway, Colchester, VT 05446 1659309615 09/05/2006 VT 790 College Parkway. University of Penn Imaging Center, 3600 Market Street, 3rd Floor Silverstein, Philadelphia, PA 19104 764089 09/05/2006 PA Sitron-Hammel Radiology Group, 4277 Hempstead Turnpike, Suite 200, Bethpage, NY 11714 W14891 09/05/2006 NY MRI of Saint Louis Obispo, 1064 Murray Avenue, San Luis Obispo, CA 93405 1881661361 09/05/2006 CA Lahey Clinic, 41 Mall Road, Burlington, MA 01805 220171 09/05/2006 MA St. Joseph Medical Center, 215 N. 12th Street, Reading, PA 19603 390096 09/05/2006 PA Spartanburg Regional Medical Center, 101 E. Wood Street, Spartanburg, SC 29303 420007 09/05/2006 SC Aurora Sinai Medical Center, 945 N. 12th Street, Milwaukee, WI 53201 520064 09/05/2006 WI FHN Memorial Hospital, 1045 W. Stephenson Street, Freeport, IL 61032 140160 09/05/2006 IL Southwest Washington Medical Center, 400 NE Mother Joseph Place, Vancouver, WA 98668 500050 09/05/2006 WA St. Lukes Center for Diagnostic Imaging, 6 McBride and Sons Corporate Center Drive, Suite 101, Chesterfield, MO 63005 47006 09/05/2006 MO The Stamford Health System, Shelbourn Road & West Broad Street, Stamford, CT 06904 70006 09/05/2006 CT Hagerstown Imaging, LLC, 1150 A Professional Court, Hagerstown, MD 21741 1518914936 09/05/2006 MD GCM Suburban Imaging, 6420 Rockledge Drive, Suite 3100, Bethesda, MD 20817 409623 09/05/2006 MD Alliance Imaging—No. Idaho Imaging, 2003 Lincoln Way, Coeur d'Alene, ID 83814 1790291 09/05/2006 ID HPMA PET Center, 22710 Professional Drive, Suite 104, Kingwood, TX 77339 0019BY 09/05/2006 TX Parma Community General Hospital, 7007 Powers Boulevard, Parma, OH 44129 360041 09/05/2006 OH Pacific Shores Medical Group PET Imaging, 1043 Elm Street #104, Long Beach, CA 90813 W13494 09/05/2006 CA Clark Memorial Hospital, 1220 Missouri Avenue, Jeffersonville, IN 47130 15009 09/05/2006 IN Abilene Imaging Center, LLC, 750 North 18th Street, Abilene, TX 79601 FTA070 09/05/2006 TX DuBois Regional Medical Center, 100 Hospital Avenue, DuBois, PA 15801 390086 09/06/2006 PA Meeker County Memorial Hospital, 612 South Sibley Avenue, Litchfield, MN 55355 241366 09/06/2006 MN Memorial Health, 4700 Waters Avenue, Savannah, GA 31403 110036 09/06/2006 GA St. Luke's Regional Medical Center, Ltd., 190 E. Bannock Street, Boise, ID 83712 130006 09/06/2006 ID Radiology Consultants Imaging Center, 400 Avenue K, SE, Winter Haven, FL 33880 U3944 09/06/2006 FL Patient Comprehensive Cancer Center, 4352 North Josey Lane, Carrollton, TX 75010 0083BY 09/06/2006 TX The University of Tennessee Medical Center, 1924 Alcoa Highway, Knoxville, TN 37920 440015 09/06/2006 TN Radiation Therapy Regional Centers—Naples, 800 Goodlette Road, Suite 110, Naples, FL 34102 77215 09/06/2006 FL St. Mary's Medical Center, 2900 First Avenue, Huntington, WV 25702 510007 09/06/2006 WV McKinney Regional Cancer Center, 4601 Medical Center Drive, McKinney, TX 75069 00711W 09/06/2006 TX WCA Hospital, PO Box 840, Jamestown, NY 14701 330239 09/06/2006 NY 207 Foote Avenue. Grants Pass Imaging and Diagnostic Center, LLC, 1619 NW Hawthorne, Suite 110, Grants Pass, OR 97526 1659307973 09/06/2006 OR Baptist Memorial Hospital—Golden Triangle, 2520 5th Street North, Columbus, MS 39705 250100 09/06/2006 MS Florida Medical Clinic, 13417 US Highway 301, Dade City, FL 33525 39715 09/06/2006 FL Saint Clare's Hospital, 400 West Blackwell Street, Dover, NJ 07801 310067 09/06/2006 NJ Radiation Medicine Associates, 2202 South 77 Sun Shine Strip, Suite E, Harlingen, TX 78550 00645N 09/06/2006 TX The Radiology Clinic, LLC, 208 McFarland Circle North, Tuscaloosa, AL 35406 13089 09/06/2006 AL Bay Area Hospital, 1775 Thompson Road, Coos Bay, OR 97420 30090 09/06/2006 OR MMI/St. Mary's Hospital, 51 US Route 1, Scarborough, ME 04074 327079 09/06/2006 ME Suite O. Gulf Coast Medical Diagnostic Center, 2024 State Avenue, Panama City, FL 32405 30930 09/06/2006 FL Diagnostic Radiology Systems, Inc., 1010 Medical Center Drive, Powderly, KY 42366 9366001 09/06/2006 KY Lewis Gale Medical Center, 1900 Electric Road, Salem, VA 24153 490048 09/06/2006 VA Radiology Diagnostic Center, 1310 Las Tablas Road, Suite 103, Templeton, CA 93465 W7491 09/06/2006 CA Weslaco Nuclear Imaging Center, 913 S. Airport Drive, Weslaco, TX 78596 1780796219 09/06/2006 TX Pioneer PET, LLC, 1930 E. Southern Avenue, Tempe, AZ 85282 1265401996 12/05/2006 AZ Kearney Imaging Center, LLC, 3219 Central Avenue, Suite 109, Kearney, NE 68847 98950 12/05/2006 NE Rose Medical Center, 4567 East 9th Avenue, Denver, CO 80220 841321373 12/05/2006 CO UCSF Medical Center, 185 Berry Street, San Francisco, CA 94107 50454 12/05/2006 CA Lobby 7, Suite 180. Broward General Medical Center, 1500 S. Andrews Avenue, Fort Lauderdale, FL 33316 100039 12/05/2006 FL St. Paul Radiology, PA/Midwest Radiology, 166 Fourth Street East, St. Paul, MN 55101 CO2661 12/05/2006 MN Queen of the Valley Hospital, 1000 Trancas Street, Napa, CA 94558 941243669 12/05/2006 CA Dana-Farber Cancer Institute, 44 Binney Street, Boston, MA 02115 220162 12/05/2006 MA Holmes Regional Medical Center, 1350 South Hickory Street, Melbourne, FL 32901 100019 12/05/2006 FL Niagara County PET Center, Niagara Falls, NY 14302 f27482 12/05/2006 NY 621 Tenth Street Department of Radiology. Augusta Medical Center, 78 Medical Center Drive, Fishersville, VA 22939 490018 12/05/2006 VA Nevada Cancer Center, 2851 North Tenaya Way, Las Vegas, NV 89128 VWQBHJ 12/05/2006 NV #100. Wellstar Kennestone Hospital Imaging Center, 340 Kennestone Hospital Boulevard, Marietta, GA 30060 110035 12/05/2006 GA Suite LL10. Ashtabula County Medical Center, 2412 Lake Avenue, Ashtabula, OH 44004 1285607416 12/05/2006 OH The Regional Cancer Center. Rowan Regional Medical Center, 514 Corporate Circle, Salisbury, NC 28147 340015 12/05/2006 NC The Pottsville Hospital and Warne Clinic, 420 South Jackson Street, Pottsville, PA 17901 390030 12/05/2006 PA Georgetown Memorial Hospital, 606 Blackriver Road, Georgetown, SC 29442 1982604021 12/05/2006 SC Medical Center of Arlington, 3301 Matlock Road, Arlington, TX 76015 450675 12/05/2006 TX Valley View Regional Hospital, 430 N. Monte Vista, Ada, OK 74820 370020 12/05/2006 OK Montgomery Medical Services, 644 Maysville Road, Suite 10, Mount Sterling, KY 40353 9141 12/05/2006 KY Medical Outsourcing Services, LLC, 5409 N. Knoxville Avenue, Peoria, IL 61614 211224 12/05/2006 IL Medical Outsourcing Services, LLC, 1300 N. Main Street, Rushville, IN 46173 223260 12/05/2006 IN Mayo Clinic Arizona, 13400 E. Shea Boulevard, Scottsdale, AZ 85259 WCTGB 12/05/2006 AZ Door County Memorial Hospital, 323 S. 18th Avenue, Sturgeon Bay, WI 54235 1093743874 12/05/2006 WI Center for Diagnostic Imaging—Sartell, 166 19th Street S., Sartell, MN 56377 C01307 12/05/2006 MN Suite 100. South Texas Institute of Cancer, 1205 South 19th Street, Corpus Christi, TX 78405 0065AZ 12/05/2006 TX Del Sol Medical Center, 10460 Vista Del Sol, El Paso, TX 79925 450646 12/05/2006 TX University Hospital, 818 St. Sebastian Way, Augusta, GA 30901 110028 12/05/2006 GA Suite 103. St. John Health System—Tulsa, OK, 1923 S. Utica Avenue, Tulsa, OK 74104 370114 12/05/2006 OK Allen Memorial Hospital, 1825 Logan Avenue, Waterloo, IA 50703 160110 12/05/2006 IA Craig General Hospital, 735 North Foreman Street, Vinita, OK 74301 370065 12/05/2006 OK Vision Imaging of Kingston, 517 Pierce Street, Kingston, PA 18704 86463 12/05/2006 PA Lake Hospital Mentor Campus, 9485 Mentor Avenue, Mentor, OH 44060 360098 12/05/2006 OH Attn:, Suite A. Excela RCL PET CT Imaging, LLC, 200 Village Drive, Greensburg, PA 15601 1144260415 12/05/2006 PA Kousay Al-Kourainy, MD, 5395 Ruffin Road #202, San Diego, CA 92123 A39783 12/05/2006 CA Memorial Hermann Northwest Hospital, 1635 North Loop West, Houston, TX 77008 450184 12/05/2006 TX Accu/Site PET/CT Imaging Center, 30 Harrison Street, Johnson City, NY 13790 DD1474 12/05/2006 NY Suite #102. DDIS—Bond, 9 Bond Street, Brooklyn, NY 11201 687s41 12/05/2006 NY West Valley Radiology Medical Group, 7301 Medical Center Drive, West Hills, CA 91307 Hw5870A 12/05/2006 CA Suite 103. Westside Diagnostic and Therapeutic Medical Center, LLC, 12524 West Washington Boulevard, Los Angeles, CA 90066 TG472 12/05/2006 CA DDIS—Still, 1783 Stillwell Avenue, Brooklyn, NY 11223 687s41 12/05/2006 NY Alpena Regional Medical Center, 1501 W. Chisholm Street, Alpena, MI 49707 386000029 12/05/2006 MI Santa Monica Imaging Center, 1245 16th Street, Suite 105, Santa Monica, CA 90404 1881670248 12/05/2006 CA Mercer County Community Hospital, 800 W. Main Street, Coldwater, OH 45828 360058 12/05/2006 OH Johnson Memorial Hospital, 1125 W. Jefferson Street, Franklin, IN 46131-2675 150001 12/05/2006 IN PO Box 549. St. Mary's Health Center, 100 St. Mary's Medical Plaza, Jefferson City, MO 65101 260011 12/05/2006 MO Eastside PET Center, LLC, 46 Medical Park East Drive, Birmingham, AL 35023 1619925070 12/05/2006 AL Suite 224. United Regional Health Care System, 1600 8th Street, Wichita Falls, TX 76301 450010 12/05/2006 TX Denton Regional Medical Center, 3535 S. I-35, Denton, TX 76210 450634 12/05/2006 TX Canton-Potsdam Hospital, 50 Leroy Street, Potsdam, NY 13676 161012691 12/05/2006 NY St. John Macomb Hospital, 11800 E. 12 Mile Road, Warren, MI 48093 230195 12/05/2006 MI Cleveland Regional Medical Center, 201 East Grover Street, Shelby, NC 28150 340021 12/05/2006 NC Bluefield Regional Medical Center, 500 Cherry Street, Bluefield, WV 24701 510071 12/05/2006 WV Charles Cole Memorial Hospital, 1001 East Second Street, Coudersport, PA 16915 390246 12/05/2006 PA New Jersey State Open MRI, 155 State Street, Hackensack, NJ 07601 85238 12/06/2006 NJ Westcoast Radiology, 501 S. Lincoln Ave., Clearwater, FL 33756 E4187 12/06/2006 FL The Iowa Clinic/PETCO, LLC, 1221 Pleasant Street, Des Moines, IA 50309 I5819 12/06/2006 IA Quantum PET—Holy Spirit Hospital, 890 Poplar Church Road, Camp Hill, PA 17011 40635 12/06/2006 PA Coastal Bend PET Scan, Ltd., 1533 5th Street, Corpus Christi, TX 78404 FTN014 12/06/2006 TX Pottstown Memorial Medical Center, 1600 E. High Street, Pottstown, PA 19464 390123 12/06/2006 PA UTMB PET/CT Imaging Center, UTMB—Rebecca Sealy Hospital, Galveston, TX 77555-0793 R518 12/06/2006 TX 301 University Blvd. Diagnostic Imaging Services, LLC, 11110 Medical Campus Road, Suite 204, Hagerstown, MD 21742 1114982808 12/06/2006 MD North Memorial Medical Center, 3435 West Broadway, Robbinsdale, MN 55422 1851344907 12/06/2006 MN Hays Medical Center, 2220 Canterbury Drive, Hays, KS 67601 2473 12/06/2006 KS St. Patrick Hospital & Health Sciences Center, 500 West Broadway, Missoula, MT 59802 1023032588 12/06/2006 MT Park Ridge Hospital, 100 Hospital Drive, Hendersonville, NC 28792 340023 12/06/2006 NC Fostoria Community Hospital, 610 Plaza Drive, Fostoria, OH 44830 361318 12/06/2006 OH UMDNJ—University Hospital, 30 Bergen Street, Newark, NJ 07101 221775306 12/06/2006 NJ ADMC 5 Room 575 P.O. Box 1709. Metabolic Imaging of Boca, 5458 Town Center Road, Suite 103, Boca Raton, FL 33486 E5434 12/06/2006 FL Olean Open MRI, 413 North 8th Street, Olean, NY 14760 AA0996 12/06/2006 NY Mercy Memorial Health Center, 1011 14th Avenue NW, Ardmore, OK 73401 731500629 12/06/2006 OK Pontiac Osteopathic Hospital d.b.a. POH Medical Center, 385 N. Lapeer Road, Oxford, MI 48371 230207 12/06/2006 MI Texas Oncology Ft. Worth, 1450 8th Avenue, Fort Worth, TX 76104 00R66C 12/06/2006 TX West Valley Imaging, 3025 S. Rainbow Boulevard, Las Vegas, NV 89146 WQBDY 12/06/2006 NV Springman Medical Plaza Imaging Center, PO Box 4650, Brownsville, TX 78523 1912973108 12/06/2006 TX EMH Regional Health Care System, 630 East River Street, Elyria, OH 44035 360145 12/06/2006 OH Denfeld Medical Center, 4702 Grand Avenue, Duluth, MN 55807 C06028 12/06/2006 MN Caldwell Memorial Hospital, 321 Mulberry Street SW, Lenoir, NC 28645 560554202 12/06/2006 NC Belleville, IL (Swansea), 4253 Argosy Court, Madison, WI 53714 208196 12/06/2006 WI Comprehensive Cancer Centers of Nevada—NW Office, 7445 Peak Drive, Las Vegas, NV 89128 WCHCX 12/06/2006 NV Wheaton Francisan Healthcare—St. Joseph, 5000 W. Chambers Street, Milwaukee, WI 53210 520136 12/06/2006 WI United Hospital Center, Rt. 19 South, Clarksburg, WV 26302-1680 510006 12/06/2006 WV #3 Hospital Plaza. Massena Memorial Hospital, 1 Hospital Drive, Massena, NY 13662 330223 12/06/2006 NY Redlands Community Hospital, 350 Terracina Boulevard, Redlands, CA 92373 ZZZ01782Z 12/06/2006 CA The Valley Hospital, 1 Valley Health Plaza, Paramus, NJ 07652 310012 12/06/2006 NJ Advanced Medical Imaging of Toms River, 1430 Hooper Avenue, Toms River, NJ 08753 447655 12/06/2006 NJ Suite 102. McKenna Memorial Hospital, 598 N. Union Street, New Braunfels, TX 78130 450059 12/06/2006 TX NSMS—Parkland Farmington, Mo, 4253 Argosy Court, Madison, WI 53714 208196 12/06/2006 WI Alton Memorial Hospital, 1 Memorial Drive, Alton, IL 62002 14002 12/06/2006 IL Medical City Dallas Hospital, Diagnostic Imaging, Dallas, TX 75230 20943901 12/06/2006 TX 7777 Forest Lane. Mercy Medical Center, 301 St. Paul Place, Baltimore, MD 21202 210008 12/06/2006 MD St. Joseph's Medical Center, 503 N. 3rd Street, Brainerd, MN 56401 240075 12/06/2006 MN Covenant Healthcare, 600 Irving Street, Saginaw, MI 48602 1457354318 12/06/2006 MI Little Company of Mary Hospital, 2800 West 95th Street, Evergreen Park, IL 60805 140179 12/06/2006 IL Marion General Hospital Progressive Medical Imagine, 830 N. Theatre Drive, Marion, IN 46952 1457354318 12/06/2006 IN Escondido Pulmonary Medical Group, 5395 Ruffin Road, Suite 202, San Diego, CA 92123 W301 12/06/2006 CA Marshall Medical Center, 1100 Marshall Way, Placerville, CA 95667 50254 12/06/2006 CA Clermont Radiology, 1804 Oakley Seaver Drive, Clermont, FL 34711 U5066 12/06/2006 FL Suite B. Mahoning Valley Imaging, Ltd., 7067 Tiffany Boulevard, Youngstown, OH 44514 1457354318 12/06/2006 OH Southeastern Ohio Regional Medical Center, 1341 Clark Avenue, Cambridge, OH 43725 1457354318 12/06/2006 OH White County Medical Center, 3214 E. Race Avenue, Searcy, AR 72143 40014 12/06/2006 AR MED Arts JVIC, 9101 Franklin Square Drive, Baltimore, MD 21237 1932167178 12/06/2006 MD Memorial Hermann Southwest OPID, 7797 SW Freeway, Houston, TX 77074 741152597 12/06/2006 TX Twin County Regional Hospital, 200 Hospital Drive, Galax, VA 24333 1174524094 12/06/2006 VA Marion Ancillary Services, LLC, 1040 Delaware Avenue, Marion, OH 43302 991 12/06/2006 OH Owensboro Medical Health Systems, Breckenridge Diagnostics, Owensboro, KY 42301 180038 12/06/2006 KY 1020 Breckenridge Street. NSMS—Darlington, WI, 209 Limestone Pass, Cottage Grove, WI 53527 92420 12/06/2006 WI Santa Fe Imaging, LLC, 1640 Hospital Drive, Santa Fe, NM 87505 400521037 12/06/2006 NM Suncoast Imaging of Port Orange, 1680 Dunlawton Avenue, Port Orange, FL 32127 40370B 12/06/2006 FL Great Basin Imaging, 2874 N Carson Street, 3rd Floor, Carson City, NV 89706 WJBDK 12/06/2006 NV St. Francis Hospital & Health Centers, 1201 Hadley Road, Mooresville, IN 46158 1457354318 12/06/2006 IN Las Colinas Cancer Center, 7415 Las Colinas Boulevard, Irving, TX 75063 00J062 12/06/2006 TX ADI, 4006 Jonathan Street, Waterloo, IA 50701 I15454 12/06/2006 IA St. Francis Hospital & Health Centers South, 8111 S. Emerson Avenue, Indianapolis, IN 46237 1457354318 12/06/2006 IN Central Baptist Diagnostic Center, 100 Southland Drive, Lexington, KY 40503 9375001 06/14/2006 KY Suite B. Baptist Health Medical Center—NLR PET/CT, 3500 Springhill Drive, North Little Rock, AR 72117 5F437 05/03/2007 AR Suite 100. Commonwealth Hematology Oncology, 216 Southtown Drive, Danville, KY 40422 1285687178 03/21/2007 KY Commonwealth Hematology Oncology, 95 Bogle Office Park Drive, Somerset, KY 42503 1285687178 03/21/2007 KY UMPC and The Washington Hospital Cancer Center, 155 Wilson Avenue, Washington, PA 15301 105589VXB 03/10/2006 PA Lexington Diagnostic Center, 1725 Harrodsburg Road, Suite 100, Lexington, KY 40504 0406 03/08/2006 KY UW PET Imaging Center, 8007 Excelsior Drive, Madison, WI 53717 1346266319 04/03/2007 WI Fort Wayne Medical Oncology and Hematology, 7910 W. Jefferson Boulevard, Suite 107, Ft. Wayne, IN 46804 055770 04/23/2007 IN Danbury Hospital, 24 Hospital Avenue, Danbury, CT 06810 070033 04/23/2007 CT Reno Diagnostic Centers, 590 Eureka Avenue, Reno, NV 89512 1518904994 04/24/2007 NV The Kirklin Clinic PET-CT Facility, 2000 6th Ave South, Birmingham, AL 35233 10933768723 05/07/2007 AL PET Imaging Radiology, PSC Paseo San Pablo 100, Bayamon, PR 0085142 05/15/2007 PR EDIF Dr. Arturo Cadilla, Suite 208. Punxsutawney Area Hospital, 81 Hillcrest Drive, Punxsutawney, PA 15767 390199 05/15/2007 PA Princeton Baptist Medical Center, 701 Princeton Avenue SW, Birmingham, AL 35211 35211 05/30/2007 AL Medical Arts Radiology Commack, 55 Veterans Memorial Highway, Commack, NY 11725 W11682 05/31/2007 NY Carrol, Sheth & Raghavan, MD, 1460 Bluegrass Avenue, Louisville, KY 40215 5460 06/05/2007 KY Personal Care Molecular Imaging, 1514 Highway 138, Wall, NJ 07719 109631 06/06/2007 NJ Lincoln Radiology Imaging, 7121 Stephanie Lane, Lincoln, NE 68516 099920 06/06/2007 NE Medcenter One, 300 North 7th Street, Bismark, ND 58506-5525 1538245634 07/24/2007 ND Wheaton Franciscan Healthcare—All Saints, 3801 Spring Street, Racine, WI 53405 520096 08/08/2007 WI N/A. Diagnostic Centers of America, 6080 Boynton Boulevard, Suite 140, Boynton Beach, FL 33437 E4439 08/22/2007 FL N/A. Center for Integrative Cancer Medicine, P.A, 1733 Curie Drive, Suite 305, El Paso, TX 79902 00315U 08/22/2007 TX N/A. St. Luke's Hospital, 1026 A Avenue N.E., Cedar Rapids, IA 52406-3026 160045 08/22/2007 IA N/A. Shared PET Imaging, LLC—Cincinnati OH, Eden Avenue & Albert Sabin Way, Cincinnati, OH 45219 ID01511 08/22/2007 OH N/A. Integrated Magnetic Imaging, 7100 University Court, Montgomery, AL 36117 7811 08/22/2007 AL N/A. Northwest PET Imaging, 265 N. Broadway Street, Portland, OR 97227 105512 08/22/2007 OR N/A. Center for Diagnostic Imaging—St. Louis Park, 5775 Wayzata Boulevard #190, St. Louis Park, MN 55416 C01307 08/22/2007 MN N/A. Ponca City Medical Center, 1900 North 14th Street, Ponca City, OK 74601 370006 08/22/2007 OK N/A. Sanford Health, 1305 W. 18th Street, Sioux Falls, SD 57117 430027 08/22/2007 SD N/A. Central Valley PET Imaging, 4744 Quail Lake Drive, Stockton, CA 95207 00A484230 08/22/2007 CA N/A. PET/CT Imaging Center, 4000 N. Illinois Lane, Swansea, IL 62226 201339 08/22/2007 IL PET/CT Imaging Center. Memorial Medical Center, 1105 W. Frank Avenue, Suite 100, Lufkin, TX 75901 450211 08/22/2007 TX d.b.a. Temple Imaging Center. Rockingham Memorial Hospital, 235 Cantrell Ave, Harrisonburg, VA 22801 490004 08/22/2007 VA N/A. Regions Imaging Center, 401 Phalen Boulevard, 41101C, St. Paul, MN 55101 240106 08/22/2007 MN N/A. Florida Hospital Imaging, LLC, 335 Clyde Morris Boulevard, Suite 250, Ormond Beach, FL 32174 1104876358 08/22/2007 FL N/A. Hutchinson Clinic, PA, 2101 North Waldron Street, Hutchinson, KS 67502 1043298474 08/22/2007 KS N/A. Parkwest Imaging, 3676 Parker Boulevard, Pueblo, CO 81008 455838 08/22/2007 CO N/A. St. Clair Hospital/UPMC Cancer Center PET/CT, 1000 Bower Hill Road, Pittsburgh, PA 15243 1699708792 08/22/2007 PA N/A. St. Joseph Mercy Oakland (SJMO), 44405 Woodward Avenue, Pontiac, MI 48341 1457354318 08/22/2007 MI N/A. Edward Hospital, 801 S. Washington Street, Naperville, IL 60540 140231 08/22/2007 IL N/A. East Montgomery Imaging Center, 6880 Winton Blount Boulevard, Montgomery, AL 36117 58866 08/22/2007 AL N/A. Memorial Hospital of Martinsville and Henry County, 320 Hospital Drive, Martinsville, VA 24112 490079 08/22/2007 VA N/A. Thomas Hospital, 750 Morphy Avenue, Fairhope, AL 36532 10100 08/22/2007 AL N/A. Portland Adventist Medical Center, 10123 SE Market Street, Portland, OR 97216 380060 08/22/2007 OR N/A. Nash Healthcare System, Inc., 2460 Curtis Ellis Drive, Rocky Mount, NC 27804 340147 08/22/2007 NC N/A. North Broward Medical Center, 201 E. Sample Road, Deerfield Beach, FL 33064 100068 08/22/2007 FL Radiology. Jennie Stuart Medical Center, 320 West 18th Street, Hopkinsville, KY 42240 180051 08/22/2007 KY N/A. Greater Houston Imaging, L.P., 6565 West Loop South, Suite 100, Bellaire, TX 77401 FTNPX1 08/22/2007 TX N/A. Sunrise Hospital Medical Center, 3186 South Maryland Parkway, Las Vegas, NV 89109 290003 08/22/2007 NV N/A. The Diagnostic and Treatment Center, 3401 Cranberry Boulevard, Weston, WI 54476 92450 08/22/2007 WI N/A. Ochsner Medical Center, 1514 Jefferson Highway, New Orleans, LA 70121 720502505 08/22/2007 LA N/A. Inland Empire Medical Imaging, 225 W. Hospitality Lane, Suite #100, San Bernardino, CA 92408 zzz316682 08/22/2007 CA N/A. Independent Nuclear PET Imaging, 1115 N. Parrott Avenue, Okeechobee, FL 34972 1922070796 08/22/2007 FL N/A. Hugh Chatham Memorial Hospital, 180 Parkwood Drive, Elkin, NC 28621 340097 08/22/2007 NC N/A. Marian Medical Center/Plaza Diagnostic Imaging, 525 E. Plaza Drive, Santa Maria, CA 93454 50107 08/22/2007 CA N/A. DDIS—FH, 8002 Kew Gardens Road, Kew Gardens, NY 11415 687s41 08/22/2007 NY N/A. NYPH—Weill Cornell, 525 E 68th Street, New York, NY 10021 131623978 08/22/2007 NY N/A. Genesys Regional Medical Center, One Genesys Parkway, Grand Blanc, MI 48439-8066 230197 08/22/2007 MI N/A. Geisinger Medical Center, 100 North Academy Avenue, Danville, PA 17822 390006 08/22/2007 PA N/A. Citrus Diagnostic Center, 922 N Citrus Avenue, Crystal River, FL 34428 K5374 08/22/2007 FL N/A. Middlesex Hospital, 534 Saybrook Road, Middletown, CT 06457 70020 08/22/2007 CT N/A. Geisinger Wyoming Valley Medical Center, 1000 East Mountain Drive, Wilkes-Barre, PA 18711 390270 08/22/2007 PA N/A. Canton, IL—Northern Shared Medical Services, 209 Limestone Pass, Cottage Grove, WI 53527 208196 08/22/2007 WI N/A. Self Regional Healthcare, 102 Academy Street, Greenwood, SC 29646 420071 08/22/2007 SC N/A. Bristol Hospital, Brewster Road, Bristol, CT 06011 70029 08/22/2007 CT P.O. Box 977. East Texas Hematology & Oncology Clinic, PA, 1202 West Frank Avenue, Lufkin, TX 75904 00T37K 08/22/2007 TX N/A. St. John River District Hospital, 4100 River Road, East China, MI 48054 230241 08/22/2007 MI N/A. Morgan Hospital, 2209 John R Wooden Drive, Martinsville, IN 46151 150038 08/22/2007 IN N/A. Cotton-O'Neil Cancer Center, 1414 SW 8th Street, Topeka, KS 66606 1811944457 08/22/2007 KS N/A. Barnes-Jewish West County Hospital, 12634 Olive Boulevard, St. Louis, MO 63141 260162 08/22/2007 MO N/A. Hardin Memorial Hospital, 913 North Dixie Avenue, Elizabethtown, KY 42701 180012 08/22/2007 KY N/A. Cancer Institute of Florida, LLC, 894 E. Altamonte Drive, Altamonte Springs, FL 32701 72793 08/22/2007 FL N/A. Community Hospital, New Port Richey, 5637 Marine Parkway, New Port Richey, FL 34652 100191 08/22/2007 FL N/A. Pulaski Community Hospital, 2400 Lee Highway, Pulaski, VA 24301 490116 08/22/2007 VA N/A. Advocate South Suburban Hospital, 17800 S. Kedzie Avenue, Hazel Crest, IL 60429 3.62169E+11 08/22/2007 IL N/A. St. Vincent's Medical Center, 2800 Main Street, Bridgeport, CT 06606 70028 08/22/2007 CT N/A. Cayuga Medical Center at Ithaca, 3218 Wilkins Road, Ithaca, NY 14850 330307 08/22/2007 NY N/A. Immanuel—St. Josephs Mayo Health Stystem, 1025 Marsh Street, Mankato MN 56002-8673 240093 08/22/2007 MN PO Box 8673. Kell West Regional Hospital, 5420 Kell West Boulevard, Wichita Falls, TX 76310 450827 08/22/2007 TX N/A. Aurora Medical Center Kenosha, 10400 75th Street, Kenosha, WI 53142 520189 08/22/2007 WI N/A. Aurora Lakeland Medical Center, W3985 County Rd NN, Elkhorn, WI 53121 520102 08/22/2007 WI N/A. Munson Medical Center, 1105 Sixth Street, Traverse City, MI 49684 230097 08/22/2007 MI N/A. Kansas City Cancer Center—North, 8700 Greenhills Road, Kansas City, MO 64154 5650000E 08/22/2007 MO N/A. PET Imaging Center of Maine, 885 Union Street, Suite 115, Bangor, ME 04401 10211501 08/22/2007 ME N/A. SMS—Chester, IL, 1900 State Street, Chester, IL 62233 208196 08/22/2007 IL N/A. PET of Reston, LP, 1800 Town Center Drive, Suite 115, Reston, VA 20190 G01960P03 08/22/2007 VA N/A. Healthcare Imaging Center, 4334 Central Ave, Riverside, CA 92506 ZZZ14451Z 08/22/2007 CA N/A. Robert Wood Johnson University Hospital at Hamilton, 1 Hamilton Health Place, Hamilton, NJ 08690 310110 08/22/2007 NJ N/A. Northside Hospital, 1000 Johnson Ferry Road, Atlanta, GA 30342 110161 08/22/2007 GA N/A. Aurora Medical Center Kenosha, 10400 75th Street, Kenosha, WI 53142 520189 08/22/2007 WI N/A. Partners Imaging Center of Sarasota, 1250 S. Tamiami Trail, Suite 103, Sarasota, FL 34239 Q0353 08/22/2007 FL N/A. Memorial Medical Center, 216 Sunset Place, Neillsville, WI 54456 521323 08/22/2007 WI N/A. Central Virginia Imaging, LLC, 1900 Tate Spings Road, Suite 21, Lynchburg, VA 24501 1578594412 08/22/2007 VA N/A. Los Alamitos Medical Center, 3951 Katella Ave, Los Alamitos, CA 90720 50551 08/22/2007 CA N/A. Valley Advanced Imaging, LLC, 2403 Butler Street, Easton, PA 18042 1417907023 08/22/2007 PA N/A. Good Samaritan PET/CT and Imaging services, 1245 Montauk Hwy, West Islip, NY 11795 330286 08/22/2007 NY N/A. Scotland Memorial Hospital, 500 Lauchwood Drive, Laurinburg, NC 28352 340008 08/22/2007 NC N/A. McFarland Clinic, P.C., 1111 Duff Avenue, Ames, IA 50010 1639135643 08/22/2007 IA N/A. Providence Hospital, 1150 Varnum Street NE, Washington, DC 20017 90006 08/22/2007 DC N/A. The Angeles Clinic and Research Institute, 11818 Wilshire Boulevard, Suite 200, Los Angeles, CA 90025 W15185A 08/22/2007 CA N/A. Rose Radiology Centers, Inc., 5107 N. Armenia Avenue, Tampa, FL 33603 1629162904 08/22/2007 FL Bldg B. Texas Oncology East Houston, 13111 East Freeway, Houston, TX 77015 1811944101 08/22/2007 TX N/A. NSMS—St. Joe's—Breese, IL, 9515 Holy Cross Lane, Breese, IL 62230 208196 08/23/2007 IL N/A. UT Cancer Institute, 7945 Wolf River Boulevard, Germantown, TN 38138 3711381 08/23/2007 TN N/A. Fresno Imaging Center, 6191 N. Rhesta Avenue, Fresno, CA 93710 N/A. 08/23/2007 CA N/A. Imaging Consultants Inc. at Sturdy Memorial, 211 Park Street, Attleboro, MA 02703 327085 08/23/2007 MA N/A. Fairfax PET Imaging Center, LLC, 8503 Arlington Boulevard Lower level, Fairfax, VA 22031 1861433674 08/23/2007 VA N/A. City Hospital, Inc., 2500 Hospital Drive, Martinsburg, WV 25401 510008 08/23/2007 WV N/A. White Plains Radiology Associates PET Center, Davis and Post Roads, White Plains, NY 10601 w11842 08/23/2007 NY N/A. Lenoir Memorial Hospital, 100 Airport Road, Kinston, NC 28503-1678 1962446385 08/23/2007 NC N/A. Sand Lake Imaging, 9350 Turkey Lake Road, Orlando, FL 32819 34896 08/23/2007 FL Suite 100. Advocate Lutheran General Center For Advanced Care, 1800 Luther Lane, Park Ridge, IL 60068 140223 08/23/2007 IL N/A. Flower Hospital, 5200 Harroun Road, Sylvania, OH 43560 360074 08/23/2007 OH N/A. Dekalb Memorial Hospital, 1316 E. 7th Street, Auburn, IN 46706 N/A. 08/23/2007 IN N/A. St. John Hospital and Medical Center, 1315 Macom Drive, Naperville, IL 60564 116 08/23/2007 IL N/A. Bayhealth Medical Center, 540 S. Governors Avenue, Dover, DE 19904 N/A. 08/23/2007 DE N/A. ImageCare, 713 Troy-Schenectady Road, Suite 124, Latham, NY 12110 1922048370 08/23/2007 NY Capital Region Health Park. Southside Regional Medical Center, 801 South Adams Street, Petersburg, VA 23803 490067 08/23/2007 VA N/A. East Alabama Medical Center—Auburn Diagnostic Imaging, 1527 Professional Parkway, Auburn, AL 36830 29 08/23/2007 AL N/A. Trover Health System, 900 Hospital Drive, Madisonville, KY 42431 1457354318 08/23/2007 KY N/A. Doctors Hospital at Renaissance, Ltd, 5501 S. McColl Road, Edinburg, TX 78359 450869 08/23/2007 TX N/A. Twin Lakes Imaging Center, 1890 LPGA Boulevard, Daytona Beach, FL 32117 1023040870 08/23/2007 FL Suite 110. Nathan Littauer Hospital, 99 E. State Street, Gloversville, NY 12078 330276 08/23/2007 NY N/A. Altoona Regional Health System, 620 Howard Avenue, Altoona, PA 16601 390073 08/23/2007 PA N/A. Warren General Hospital, 2 Crescent Park West, Warren, PA 16365 390146 08/23/2007 PA N/A. Reid Hospital Health Care Services, 1401 Chester Boulevard, Richmond, IN 47374 1457354318 08/23/2007 IN N/A. Orange City Area Health System, 1000 Lincoln Circle SE, Orange City, IA 51041 161360 08/23/2007 IA N/A. Mercy Hospital Clermont, 3000 Hospital Drive, Batavia, OH 45103 1457354318 08/23/2007 OH N/A. Arroyo Grande Community Hospital, 345 South Halcyon Road, Arroyo Grande, CA 93454 50016 08/23/2007 CA N/A. HealthEast St. John's Hospital, 1575 Beam Avenue, Maplewood, MN 55109 240210 08/23/2007 MN N/A. St. Joseph's/Candler Health System, 5353 Reynolds Street, Savannah, GA 31405 110024 08/23/2007 GA N/A. NSMS—Pickneyville, IL, 101 North Walnut Street, Pinckneyville, IL 62274 208196 08/23/2007 IL N/A. Duke Raleigh Hospital, 3400 Wake Forrest Road, Raleigh, NC 27609 340073 08/23/2007 NC N/A. Advanced Radiology Services & The Center for Women, 400 Plaza Court, East Stroudsburg, PA 18301 33012 08/23/2007 PA Suite C. Community Hospital, 10020 Donald S. Powers Drive, Munster, IN 46321 140125 08/23/2007 IN N/A. Avant Imaging—Woodland Health Center, 7575 Grand River Avenue, Brighton, MI 48114 1457354318 08/23/2007 MI N/A. EVDI Medical Imaging—East Mesa, 6424 E. Broadway Road, Mesa, AZ 85206 1164434098 08/23/2007 AZ Suite 101. NSMS—St. Louis, Mo—ARCH Medical, 209 Limestone Pass, Cottage Grove, WI 53527 47013 08/23/2007 WI N/A. CNY PET LLC, 5100 West Taft Road, Liverpool, NY 13088 AA0672 08/23/2007 NY Suite 2C. MCMI, 3000 Telegraph Avenue, Oakland, CA 94609 ZZZ27496Z 08/23/2007 CA N/A. Green Clinic, LLC, 1200 S. Farmerville Street, Ruston, LA 71270 57387 08/23/2007 LA N/A. Fayette Memorial Hospital, 3542 North Western Avenue, Connersville, IN 47331 150064 08/23/2007 IN N/A. Carolinas Medical Center—Union, 600 Hospital Drive, Monroe, NC 28112 340130 08/23/2007 NC Nuclear Medicine Department. Citrus Medical Imaging Associates, Inc., 1000 Lakes Drive, Suite 170, West Covina, CA 91790 HW2326 08/23/2007 CA N/A. Radiation Oncology at WFUBMC, Radiation Oncology Medical Center Boulevard, Winston-Salem, NC 27152 340047 08/24/2007 NC Wake Forest University Baptist Medical Center Comprehensive Cancer Center. Harrison County Hospital, 245 Atwood Street, Corydon, IN 47112 151331 08/24/2007 IN N/A. Thibodaux Regional Medical Center, 602 North Acadia Road, Thibodaux LA 70301 190004 08/24/2007 LA N/A. NSMS—Hot Springs, AR, 1600 Higdon Ferry Road, Hot Springs AR 71913 5F168 08/24/2007 AR N/A. Pacific Oncology, PC, 15700 SW Greystone Court, Beaverton OR 97006 1043262116 08/24/2007 OR N/A. Cancer Care Associates, 1791 E. Fir Avenue, Fresno, CA 93720 222375652 08/24/2007 CA N/A. Massatusetts Mobile PET, PC—Newburyport, 25 Highland Avenue, Newburyport, MA 01950 327086 08/24/2007 MA N/A. Hematology Oncology Associates of Illinois, 6801 West 34th Street, Berwyn, IL 60402 218890 08/24/2007 IL Suite 107. Massatusetts Mobile PET, PC— Haverhill, 140 Lincoln Avenue, Haverhill, MA 01830 327086 08/24/2007 MA N/A. Corinth Medical Group, 4851 I35 East, Suite 101, Corinth, TX 76210 00K22X 08/24/2007 TX N/A. New England PET Imaging Manchester, One Elliot Way, Manchester, NH 03103 327081 08/24/2007 NH N/A. The Surgery Clinic, 1026 Goodyear Avenue, Gadsden, AL 35999 N/A 08/24/2007 AL Suite B-101. Boston Medical Center, 830 Harrsion Avenue, Boston, MA 02118 220031 08/24/2007 MA Suite 1600. Mercy Health Center, 4190 24th Avenue, Fort Gratiot, MI 48059 1457354318 08/24/2007 MI N/A. The Cancer Center of Santa Barbara, 300 W. Pueblo Street, Santa Barbara, CA 93105 W13890 08/24/2007 CA N/A. Milford Memorial Hospital Bayhealth Medical Center, 21 W. Clarke Avenue, Milford, DE 19963 N/A 08/24/2007 DE N/A. North Coast Cancer Care, 417 Quarry Lakes Drive, Sandusky, OH 44870 NO9915215 08/24/2007 OH N/A. Palm Beach Gardens Open Imaging Center, 3335 Burns Road #101, Palm Beach Gardens, FL 33408 U8767 08/24/2007 FL N/A. Advanced Medical Imaging, LLC, 1780 NW Myhre Road, Silverdale, WA 98383 AB24179 08/24/2007 WA Suite 1220. Swedish American Hospital, 1401 E State Street, Rockford, IL 61104 140228 08/24/2007 IL N/A. Molecular Diagnostics of Eastern Omaha, 117 North 32nd Avenue, Suite 100, Omaha, NE 68131 99894 08/24/2007 NE N/A. Kingwood Medical Center, 22999 U.S. Hwy 59, Kingwood, TX 77339 1811942238 08/24/2007 TX N/A. Health Village Imaging, 1301 Route 72 West, Manahawkin, NJ 08050 1194810978 08/24/2007 NJ Suite 100. ARH Hazard, 100 Medical Center Drive, Hazard, KY 41701 520795508 08/24/2007 KY N/A. Central Florida Imaging Center, Inc., 6801 US 27 N, Suite E-3, Sebring, FL 33870 1427076769 08/24/2007 FL N/A. West Texas Cancer Center, 301 N Washington Avenue, Odessa, TX 79761 00543K 08/24/2007 TX N/A. Beloit Memorial Hospital, 1969 West Hart Road, Beloit, WY 53511 520100 08/24/2007 WY N/A. Pinnacle Imaging Center, 2390 NW 7th Street, Miami, FL 33125 U5131 08/24/2007 FL Suite 103. PET Imaging of El Paso, 1225 E. Cliff Drive, El Paso, TX 79902 FTN035 08/24/2007 TX Building 3, Suite 200. St. Petersburg General Hospital, 6500 38th Avenue North, St. Petersburg, FL 33710 N/A 08/24/2007 FL N/A. St. Mary Medical Center, 1201 Langhorne-Newtown Road, Langhorne, PA 19047 390258 08/24/2007 PA N/A. St. Joseph Medical Center, 1401 St. Joseph Parkway, Houston, TX 77002 1154361475 08/24/2007 TX N/A. UPMC Northwest, 1671 Allegheny Boulevard, Reno, PA 16343 390091 08/24/2007 PA N/A. Mercy Hospital Fairfield, 3000 Mack Road, Fairfield, OH 45014 1457354318 08/24/2007 OH N/A. Radiology Associates of West Pasco, 5539 Marine Parkway, New Port Richey, FL 34652 1558328963 08/24/2007 FL N/A. St. Dominic Hospital, 969 Lakeland Drive, Jackson, MS 39216 250048 08/24/2007 MS N/A. RCOA—Adventist Health—Sequoia, 4949 W. Cypress Avenue, Visalia, CA 93271 1427198696 08/24/2007 CA N/A. McKee Medical Center, 2000 Boise Ave, Loveland, CO 80538 60030 08/24/2007 CO N/A. Bon Secours Richmond Community Hospital, 1500 North 28th Street, Richmond, VA 23223 490094 08/24/2007 VA N/A. West Houston Medical Center, 12141 Richmond Avenue, Houston, TX 77082 450644 08/24/2007 TX N/A. Shands Teaching Hospital and Clinics, Inc., 2000 SW Archer Road, Gainesville, FL 32608 100113 08/24/2007 FL Radiology, Shands Medical Plaza. Tanner Medical Center, 119 Ambulance Drive, Carrollton, GA 30117 110011 08/24/2007 GA N/A. OU Medical Center, 700 NE 13th Street, Oklahoma City, OK 73104 1780631390 08/24/2007 OK N/A. The Medical Center of Aurora, 1400 S. Potomac Street, Aurora, CO 80012 60100 08/24/2007 CO #180. AllenRidge Diagnostic Imaging Center, 520 Lecanto Highway, Lecanto, FL 34461 100023 08/24/2007 FL N/A. The PET Center at BWMC, 305 Hospital Drive, Baltimore, MD 21061 1124016696 08/24/2007 MD SUITE 302. Signet Diagnostic Imaging Services, LLC, 8300 West Sunrise Boulevard, Plantation, FL 33322 E8667 08/24/2007 FL N/A. Adams Diagnostic Imaging, 20 Expedition Trail, Gettysburg, PA 17325 65290 08/24/2007 PA Suite 102. Jennie Edmundson Hospital, 933 E. Pierce Street, Council Bluffs, IA 51503 160047 08/24/2007 IA N/A. Holy Cross Hospital, 4725 N. Federal Highway, Fort Lauderdale, FL 33308 100073 08/24/2007 FL Bienes Diagnostic Imaging Center. Medical University of Ohio, 3000 Arlington Avenue, Toledo, OH 43614 1457354318 08/24/2007 OH N/A. Daviess Community Hospital, 1314 E Walnut Street, Washington, IN 47501 150061 08/24/2007 IN Radiology Department. Jeff Anderson Regional Medical Center, 2124 14th Street, Meridian, MS 39301 250104 08/24/2007 MS N/A. Modesto Imaging Center, 157 E. Coolidge Avenue, Modesto, CA 95350 ZZZ01977Z 08/24/2007 CA N/A. Sioux Center Commmunity Hospital and Health Center, 605 South Main Ave, Sioux Center, IA 51250 161346 08/24/2007 IA N/A. Southern Ohio Medical Center, 1121 Kinneys Lane, Portsmouth, OH 45662 360008 08/24/2007 OH N/A. Massachusetts General Hospital, 55 Fruit Street, Boston, MA 02114 220071 08/24/2007 MA N/A. Clinton Memorial Hospital Regional Health System, 31 Farquhar Avenue, Wilmington, OH 45177 316005307 08/24/2007 OH N/A. CJW Medical Center, 1401 Johnston Willis Drive, Richmond, VA 23235 34632 08/24/2007 VA N/A. Texas Oncology Weatherford, 907 Foster Lane, Weatherford, TX 76086 00539K 08/24/2007 TX N/A. Sharper Imaging Diagnostic Radiology Center, 3430 Tamiami Trail, Port Charlotte, FL 33952 1730288515 08/24/2007 FL Suite B. Morristown—Hamblin Healthcare System, 908 W. 4th N. Street, Morristown, TN 37814 1457354318 08/24/2007 TN N/A. Puget Sound PET Imaging, 6808 220th Street SW, Mountlake Terrace, WA 98043 115162600 08/24/2007 WA Suite 150. Detar Hospital Navarro, 506 E. San Antonio Street, Victoria, TX 77902 450147 08/24/2007 TX N/A. PET Imaging of Chicago, 6801 West 34th Street, Suite 105 Berwyn, IL 60402 214832 08/24/2007 IL N/A. Imaging Specialists Group, Ltd., 3101 Churchill Road, Flower Mound, TX 75022 1417991852 08/24/2007 TX Suite 100. OKOmed Downtown Imaging, 2101 Crawford Street, Suite 115, Houston, TX 77002 1780622464 08/24/2007 TX N/A. Clear Lake Regional Medical Center, 500 Medical Center Boulevard, Webster, TX 77598 1063466035 08/24/2007 TX N/A. Norton Hospital, 315 East Broadway, Louisville, KY 40202 180088 08/24/2007 KY N/A. Saratoga PET Associates, LLC, 3 Emma Lane, Clifton Park, NY 12065 1356357172 08/24/2007 NY N/A. Genesis Health Care System, 2800 Maple Avenue, Zanesville, OH 43701 1457354318 08/24/2007 OH N/A. Lake Cumberland Regional Hospital, 27 Imaging Drive, Somerset, KY 42503 1457354318 08/24/2007 KY N/A. Saint Francis Cancer Institute, 14 Doctors' Park, Cape Girardeau, MO 63703 260183 08/24/2007 MO N/A. American Health Network of IN, LLC—PET/CT, 6820 Parkdale Place, Indianapolis, IN 46254 1164491775 08/24/2007 IN Suite #105. PET CT Nuclear Radiology, Inc., 1501 Edisicio Detantacourt, Suite 302, Fernadez Juncos Santorze, PR 909 57886 08/24/2007 PR Fernadez Juncos Santorze. NSMS—Reedsburg, WI, 2000 North Dewey Street, Reedsburg, WI 53959 1295785079 08/24/2007 WI N/A. Wayne Memorial Hospital, 2700 Wayne Memorial Hospital, Goldsboro, NC 27534 340010 08/24/2007 NC N/A. InMed Diagnostic Services of IL, 10419 Fleming Road, Carterville, IL 62918 205040 08/24/2007 IL N/A. Henrico Doctors' Hospital, 1602 Skipwith Road, Richmond, VA 23229 490118 08/24/2007 VA N/A. Alliance Imaging—United General Hospital, 2000 Hospital Drive, Sedro Woolley, WA 98284 8862377 08/24/2007 WA N/A. Spencer Municipal Hospital, 1200 First Avenue East, Spencer, IA 51301 1255328621 08/24/2007 IA N/A. Radilogy LTD LaCholla Center—Diagnostic Imaging, 5960 N. LaCholla Avenue, Tucson, AZ 85704 1841261989 08/24/2007 AZ N/A. Saint Elizabeth Regional Medical Center, 555 South 70th Street, Lincoln, NE 68510 280020 08/24/2007 NE N/A. Bucyrus Community Hospital, 629 N. Sandusky Avenue, Bucyrus, OH 44820 361316 08/24/2007 OH N/A. Mercy Hospital of Willard, 110 E. Howard Street, Willard, OH 44890 361310 08/24/2007 OH N/A. Lower Columbia Pathologists, 1606 East Kessler Boulevard, Longview, WA 98632 745800 08/24/2007 WA 4th Floor. Newton Medical Center, 600 Medical Center Drive, Newton, KS 67114 170103A 08/24/2007 KS N/A. Advanced Imaging Partners, 508 Cleveland Street, Great Bend, KS 67530 1295791325 08/24/2007 KS N/A. Integrated Medical Imaging, 1040 Greenwood Springs Boulevard, Greenwood, IN 46143 221970 08/24/2007 IN N/A. Avera Sacred Heart Cancer Center, 501 Summit Street, Yankton, SD 57078 430012 08/24/2007 SD N/A. ValleyCare Medical Center, 5555 W. Las Positas Boulevard, Pleasanton, CA 94588 50283 08/24/2007 CA N/A. NSMS—Mena, AR, 311 North Morrow Street, Mena, AR 71953 1295785079 08/24/2007 AR N/A. Memorial Hospital Easton, 219 S. Washington Street, Easton, MD 21601 210037 08/24/2007 MD N/A. Seattle Cancer Care Alliance, 825 Eastlake Avenue E, Seattle, WA 98109 500138 08/24/2007 WA Medical Imaging. Alliance Imaging—The Vancouver Clinic, 700 NE 87th Avenue, Vancouver, WA 98664 8864364 08/24/2007 WA N/A. Martin Center for Diagnostic and Imaging Services, 3901 S. Fremont Avenue, Springfield, MO 65804 260040 08/24/2007 MO N/A. Aultman Hospital, 2600 Sixth Street SW, Canton, OH 44710 1457354318 08/24/2007 OH N/A. Imaging Consultants, Inc. at Harrington Memorial, 600 Federal Street, Andover, MA 01810 327085 08/24/2007 MA N/A. Rhode Island Pet Services at Kent County, 600 Federal Street, Andover, MA 01810 1538113113 08/24/2007 MA N/A. Imaging Consultants Inc. at Hawthorn, 600 Federal Street, Andover, MA 01810 1851449078 08/24/2007 MA N/A. Swedish Covenant Hospital, 5145 N California Avenue, Chicago, IL 60625 362179813 08/24/2007 IL N/A. Banner Baywood Medical Center, 6644 E. Baywood Avenue, Mesa, AZ 85206 30088 08/24/2007 AZ N/A. Lourdes Hospital, 1530 Lone Oak Road, Padukah, KY 42003 1346244126 08/24/2007 KY N/A. St Vincent Oncology Center, 8301 Harcourt Road, Indianapolis, IN 46260 150084 08/24/2007 IN N/A. United Hospital System, Inc., 9555 76th Street, Pleasant Prairie, WI 53518 520021 08/24/2007 WI N/A. East Tennessee Diagnostic Center, 1450 Dowell Springs Boulevard, Suite 210, Knoxville, TN 37909 1710932553 08/24/2007 TN N/A. Nazareth Hospital, 8400 Roosevelt Boulevard, Philadelphia, PA 19152 390204A 08/24/2007 PA N/A. Good Samaritan Hospital, 2425 Samaritan Drive, San Jose, CA 95124 50380 08/24/2007 CA N/A. MedSpecialists Imaging Center, 1064 Keene Road, Dunedin, FL 34698 AB585 08/24/2007 FL N/A. NSMS—Pekin, IL, 2355 Broadway Road, Pekin, IL 61544 1295785079 08/24/2007 IL N/A. Bluegrass Regional Imaging, LLC, 701 Bob-O-Link Drive, Lexington, KY 40504 1871542670 08/24/2007 KY Suite 245. Fairfax Pet Imaging Center, 8503 Arlington Boulevard, Fairfax, VA 22031 1831220714 08/24/2007 VA Suite 120LL. Lodi Community Hospital, 225 Elyria Street, Lodi, OH 44254 361303 08/24/2007 OH N/A. Legacy Meridian Park Hospital, 19260 SW 65th Avenue, Suite 165, Tualatin, OR 97062 380089 08/24/2007 OR N/A. Galion Community Hospital, 269 Portland Way South, Galion, OH 44833 361325 08/24/2007 OH N/A. Oncology Hematology Associates of Central Illinois, 8940 N. Wood Sage Road, Peoria, IL 61615, 616880 08/24/2007 IL N/A. Mid Ohio Oncology/Hematology, Inc., 3100 Plaza Properties Boulevard, Columbus, OH 43219 1376509661 08/24/2007 OH N/A. Kentucky Imaging Center, 3475 Richmond Road, Lexington, KY 40509 1992876981 08/24/2007 KY SUITE 150. Salem Community Hospital, 1995 East State Street, Salem, OH 44460 1639131535 08/24/2007 OH N/A. Belmont Community Hospital, 51339 National Road, St. Clairsville, OH 43950 360153 08/24/2007 OH N/A. Golder CT and MRI Center, 613 North Golder Avenue, Odessa, TX 79761 N/A 08/24/2007 TX N/A. NSMS—Reedsburg, WI, 2000 North Dewey Street, Reedsburg, WI 53959 1295785097 08/24/2007 WI N/A. MaineGeneral Medical Center, 361 Old Belgrade Road, Augusta, ME 04330 200039A 08/24/2007 ME N/A. The Oklahoma PET Center, PLLC, 5401 N. Portland Avenue, Suite 330, Oklahoma City, OK 73112 569959716M 08/24/2007 OK N/A. NSMS—Blytheville, AR, 1520 North Division Street, Blytheville, AR 72316 1295785079 08/24/2007 AR N/A. NSMS—Benton, AR, 1 Medical Park Drive, Benton, AR 72015 1295785079 08/24/2007 AR N/A. Mercy Health System, 1000 Mineral Point Avenue, Janesville, WI 53548 520066 08/24/2007 WI N/A. WA Foote Memorial Hospital, 205 N. East Avenue, Jackson, MI 49201 230092 08/24/2007 MI N/A. Northern Michigan Hospital, 416 Connable Avenue, Petoskey, MI 49770 230105 08/24/2007 MI N/A. Anchor Health Centers, 800 Goodlette Road N., Naples, FL 34102 1174571608 08/24/2007 FL Suite 130. New Ulm Medical Center, 1324 5th North Street, New Ulm, MN 56073 2880 08/24/2007 MN N/A. Radiology Associates of Brooklyn LLP, 2021 Avenue X, Brooklyn, NY 11235-2905 1134244916 08/24/2007 NY N/A. NYOH Mobile PET/CT Hudson, 69 Prospect Road, Hudson, NY 12534 1609863448 08/24/2007 NY N/A. Integris Bass Baptist Health Center, 600 South Monroe, Enid, OK 73703 1144236571 08/24/2007 OK N/A. Imaging Consultants Inc at Weymouth Woods, 59 Performance Drive, Weymouth, MA 2188 1487690335 08/24/2007 MA N/A. St. Vincent Medical Center, 2131 W. Third Street, Los Angeles, CA 90057 50502 08/24/2007 CA N/A. Caritas PET Imaging, LLC at Holyoke Medical Center, 575 Beech Street, Holyoke, MA 1040 327087 08/24/2007 MA N/A. St. James Healthcare, 400 South Clark, Butte, MT 59701 270017 08/24/2007 MT N/A. Inglewood Imaging Center, 211 N. Prairie Avenue, Inglewood, CA 90301 TD097 08/24/2007 CA N/A. Duncan Regional Hospital, 1700 Whisenant Drive, Duncan, OK 73534 370023 08/24/2007 OK PO Box 100. OhioHealth Ambulatory PET/CT, 500 Thomas Lane, Columbus, OH 43214 360006 08/24/2007 OH N/A. Baylor Diagnostic Imaging Center at Junius, 3900 Junius Street, Suite 100 Dallas, TX 75246 450021 08/24/2007 TX N/A. PET/CT Imaging at White Marsh, 9900 Franklin Square Drive, Suite D, Nottingham, MD 21236 FMNX01 08/28/2007 MD N/A. Central Baptist Diagnostic Center, 100 Southland Drive, Lexington, KY 40503 9375001 06/14/2006 KY Suite B. Baptist Health Medical Center—NLR PET/CT, 3500 Springhill Drive, North Little Rock, AR 72117 5F437 05/03/2006 AR Suite 100. Commonwealth Hematology Oncology, 95 Bogle Office Park Drive, Somerset, KY 42503 1285687178 03/21/2007 KY N/A. Commonwealth Hematology Oncology, 216 Southtown Drive, Danville, KY 40422 1285687178 03/21/2007 KY N/A. Jefferson Center City Imaging, 850 Walnut Street, Philadelphia, PA 19107 66277 09/07/2007 PA N/A. EPIC Imaging Center, 233 NE 102 Avenue, Portland, OR 97220 0000WCGNQ 09/11/2007 OR N/A. UPMC and The Washington Hospital Cancer Center, 155 Wilson Avenue, Washington, PA 15301 105589VXB 03/10/2006 PA N/A. Lexington Diagnostic Center, 1725 Harrodsburg Road, Suite 100, Lexington, KY 40504 0406 03/08/2006 KY N/A. UW PET Imaging Center, 8007 Excelsior Drive, Madison, WI 53717 1346266319 04/03/2007 WI N/A. NorCal Imaging—Oakland, 3200 Telegraph Avenue, Oakland, CA 94609 ZZZ05319Z 08/22/2007 CA N/A. NorCal Imaging—Walnut Creek, 114 La Casa Via, Suite #100, Walnut Creek, CA 94598 ZZZ05319Z 08/22/2007 CA N/A. Aurora Sheboygan Memorial Imaging Center, 2629 North 7th Street, Sheboygan, WI 53083 520035 05/08/2008 WI Aurora Memorial Hospital of Burlington, 252 McHenry Street, Burlington, WI 53105 520059 05/08/2008 WI Aurora Medical Center—Manitowoc County, 5000 Memorial Drive, Two Rivers, WI 54241 520034 05/08/2008 WI Addendum XIII—Medicare-Approved Ventricular Assist Device (Destination Therapy) Facilities [January Through March 2008] On October 1, 2003, we issued our decision memorandum on ventricular assist devices for the clinical indication of destination therapy. We determined that ventricular assist devices used as destination therapy are reasonable and necessary only if performed in facilities that have been determined to have the experience and infrastructure to ensure optimal patient outcomes. We established facility standards and an application process. All facilities were required to meet our standards in order to receive coverage for ventricular assist devices implanted as destination therapy. The following facilities have met the CMS facility standards for destination therapy VADs. VAD Destination Therapy Facilities Facility Provider No. Date approved State Other information Advocate Christ Medical Center, 4440 W 95th Street, Oak Lawn, Illinois 140208 12/17/2003 IL California Pacific Medical Center, 2333 Buchanan Street, San Francisco, California 050047 03/19/2004 CA Baptist Memorial Hospital, 6019 Walnut Grove Road, Memphis, Tennessee 440048 04/07/2004 TN Duke University Medical Center, DUMC Box 3943, Durham, North Carolina 340030 10/31/2003 NC Fairview-University Medical Center, 2450 Riverside Avenue, Minneapolis, Minnesotta 240080 10/28/2003 MN Allegheny General Hospital, 320 E North Avenue, Pittsburgh, Pennsylvania 390050 12/10/2003 PA Barnes-Jewish Hospital, One Barnes-Jewish Hospital Plaza, Saint Louis, Missouri 260032 10/27/2003 MO Brigham and Women's Hospital, 15 Francis Street, Boston, Massachusetts 220110 01/09/2004 MA Bryan LGH Medical Center East, 1600 S 48 Street, Lincoln, Nebraska 280003 10/23/2003 NE Cedars-Sinai Medical Center, 8700 Beverly Boulevard, Los Angeles, California 050625 12/29/2003 CA Clarian Health Partners, Inc., 1701 N. Senate Avenue, Indianapolis, Indiana 150056 11/25/2003 IN Cleveland Clinic, 9500 Euclid Avenue, Cleveland, Ohio 360180 12/03/2003 OH Hahnemann University Hospital, Broad and Vine Streets, Philadelphia, Pennsylvania 390290 12/22/2003 PA Hospital of the University of Pennsylvania, 3400 Spruce Street, Philadelphia, Pennsylvania 390111 10/28/2003 PA Henry Ford Hospital, 2799 W. Grand Boulvard, Detroit, Michigan 230053 01/06/2004 MI Inova Fairfax Hospital, 3300 Gallows Road, Falls Church, Virginia 490063 03/31/2004 VA Jewish Hospital, 200 Abraham Flexner Way, Louisville, Kentucky 180040 11/10/2003 KY Jackson Memorial Hospital, 1611 NW 12th Avenue, Miami, Florida 100022 01/12/2004 FL University of Miami. LDS Hospital, 8th Avenue and C Street, Salt Lake City, Utah 460010 10/23/2003 UT Johns Hopkins Hospital, 600 N. Wolfe Street, Baltimore, Maryland 210009 10/28/2003 MD Loyola University Medical Center, 2160 S. 1st Avenue, Maywood, Illinois 140276 01/30/2004 IL Lutheran Hospital of Indiana, 7950 W. Jefferson Boulevard, Fort Wayne, Indiana 150017 10/29/2003 IN Massachusetts General Hospital, 55 Fruit Street, Boston, Massachusetts 220071 12/15/2003 MA Mayo Clinic, 4500 San Pablo Road, Jacksonville, Florida 100151 11/06/2003 FL Medical City Dallas Hospital, 7777 Forest Lane, Dallas, Texas 450647 12/03/2003 TX The Methodist Hospital, 6565 Fannin Street, Houston, Texas 450358 11/03/2003 TX Montefiore Medical Center, 111 E. 210th Street, Bronx, New York 330059 11/14/2003 NY Methodist Specialty and Transplant Hospital, 8026 Floyd Curl Drive, San Antonio, Texas 450388 11/19/2003 TX Newark Beth Israel Medical Center, 201 Lyons Avenue, Newark, New Jersey 310002 11/14/2003 NJ Mount Sinai Medical Center, 1190 5th Avenue, New York, New York 330024 11/25/2003 NY New York-Presbyterian Hospital, 177 Fort Washington Avenue, New York, New York 330101 10/28/2003 NY Columbia University Medical Center. Ohio State University Medical Center, 410 W. 10th Avenue, Columbus, Ohio 360085 11/12/2003 OH Oregon Health and Sciences University, 3181 SW Sam Jackson Park Road, Portland, Oregon 380009 11/21/2003 OR OSF St Francis Medical Center, 530 NE Glen Oak Avenue, Peoria, Illinois 140067 11/12/2003 IL Penn State Milton S Hershey Medical Center, 500 University Drive, Hershey, Pennsylvania 390256 10/29/2003 PA Rush-Presbyterian-St Luke Medical Center, 1653 W Congress Parkway, Chicago, Illinois 140119 11/14/2003 IL Sentara Norfolk General Hospital, 600 Gresham Drive, Norfolk, Virginia 490007 11/10/2003 VA Sacred Heart Medical Center, 101 W 8th Avenue, Spokane, Washington 500054 01/12/2004 WA Seton Medical Center, 1201 W. 38th Street, Austin, Texas 450056 01/13/2004 TX Shands at the University of Florida, 1600 SW Archer Road, Gainesville, Florida 100113 11/26/2003 FL Sharp Memorial Hospital, 7901 Frost Street, San Diego, California 050100 12/01/2003 CA Stanford University Hospital and Clinics, 300 Pasteur Drive, Stanford, California 050441 12/22/2003 CA Stanford University Medical Center. St Francis Hospital, 6161 S. Yale Avenue, Tulsa, Oklahoma 370091 01/09/2004 OK St Luke's Medical Center, 2900 W Oklahoma Avenue, Milwaukee, Wisconsin 520138 11/03/2003 WI St Luke's Episcopal Hospital, 6720 Bertner Avenue, Houston, Texas 450193 10/28/2003 TX St Vincent Hospital and Health Services, 2001 W. 86th Street, Indianapolis, Indiana 150084 01/05/2004 IN St Paul Medical Center, 5909 Harry Hines Boulevard, Dallas, Texas 450044 12/10/2003 TX Strong Memorial Hospital, 601 Elmwood Avenue, Rochester, New York 330285 10/29/2003 NY Tampa General Hospital, 2 Columbia Drive, Tampa, Florida 100128 11/26/2003 FL Temple University Hospital, 3401 N. Broad Street, Philadelphia, Pennsylvania 390027 11/03/2003 PA Tufts-New England Medical Center, 750 Washington Street, Boston, Massachusetts 220116 11/06/2003 MA UCLA Medical Center, 10833 Le Conte Avenue, Los Angeles, California 050262 12/10/2003 CA University Medical Center, 1501 N. Campbell Avenue, Tucson, Arizonia 030064 10/29/2003 AZ University of Alabama at Birmingham Health System, 500 22nd Street S., Birmingham, Alabama 010033 10/29/2003 AL University of Colorado Hospital, 4200 E. Ninth Avenue, Denver, Colorado 060024 11/06/2003 CO 9th & Colorado Campus. The University of Chicago Hospitals and Health System, 5841 South Maryland Avenue, Chicago, Illinois 140088 02/25/2004 IL University of Iowa Hospitals and Clinics, 200 Hawkins Drive, Iowa City, Iowa 160058 11/12/2003 IA University of Maryland Medical Center, 22 S. Greene Street, Baltimore, Maryland 210002 11/12/2003 MD University of Michigan Health System, 1500 E. Medical Center Drive, Ann Arbor, Michigan 230046 10/27/2003 MI University of North Carolina Hospitals, 101 Manning Drive, Chapel Hill, North Carolina 340061 05/05/2004 NC University of Utah Hospital, 50 N Medical Drive, Salt Lake City, Utah 460009 12/22/2003 UT University of Virginia Health System, 1215 Lee Street, Charlottesville, Virginia 490009 01/12/2004 VA University of Washington Medical Center, 1959 NE Pacific Street, Seattle, Washington 500008 01/15/2004 WA University of Wisconsin Hospitals and Clinics, 600 Highland Avenue, Madison, Wisconsin 520098 12/03/2003 WI USC University Hospital, 1500 San Pablo, Los Angeles, California 050696 01/09/2004 CA UPMC Presbyterian, 200 Lothrop Street, Pittsburgh, Pennsylvania 390164 10/23/2003 PA Virginia Commonwealth University Medical Center, 401 North 12th Street, Richmond, Virginia 490032 04/08/2004 VA Medical College of Virginia Hospitals. Vanderbilt University Medical Center, 1161 21st Avenue S., Nashville, Tennessee 440039 10/28/2003 TN Ochsner Clinic Foundation, 1514 Jefferson Highway, New Orleans, Louisiana 190036 06/29/2004 LA Baylor University Medical Center, 3500 Gaston Avenue, Dallas, TX 75246 N/A 10/04/2007 TX The University of Michigan Hospitals and Health Centers, 1500 East Medical Center Drive, Ann Arbor, MI 48109 230046 03/28/2008 MI Saint Mary's Hospital, 1216 Southwest Second Street, Rochester, MN 55902 N/A 02/27/2008 MN Allegheny General Hospital, 320 East North Avenue, Pittsburgh, PA 15212 N/A 03/08/2008 PA Washington Hospital Center, 110 Irving Street, NW., Washington, DC 20010 09-0011 04/23/2008 DC Addendum XIV—Lung Volume Reduction Surgery

(LVRS)[January Through March 2008] Three types of facilities are eligible for reimbursement for Lung Volume Reduction Surgery (LVRS): National Emphysema Treatment Trial

(NETT)approved (Beginning 05/07/2007, these will no longer automatically qualify and can qualify only with the other programs), Credentialed by the Joint Commission on Accreditation of Healthcare Organizations (JCAHO) under their Disease Specific Certification Program for LVRS, and Medicare approved for lung transplants. Only the first two types are in the list. Facility name Date approved State Type of certification Baylor College of Medicine, Houston, Texas N/A TEXAS NETT. Brigham and Women's Hospital, Boston, MA N/A MASSACHUSETTS NETT. Cedars-Sinai Medical Center, Los Angeles, CA N/A CALIFORNIA NETT. Chapman Medical Center, Orange, CA N/A CALIFORNIA NETT. Cleveland Clinic Foundation, Cleveland, OH N/A OHIO NETT. Columbia University, New York, NY N/A NEW YORK NETT. Duke University Medical Center, Durham, NC N/A NORTH CAROLINA NETT. Johns Hopkins Hospital, Baltimore, MD N/A MARYLAND NETT. Kaiser Foundation Hospital—Riverside, Riverside, CA 09/20/2006 CALIFORNIA JCAHO. Long Island Jewish Medical Center, New Hyde Park, NY N/A NEW YORK NETT. Mayo Clinic, Rochester, MN N/A MINNESOTA NETT. Memorial Medical Center, Springfield, IL 12/13/2006 ILLINOIS JCAHO. National Jewish Medical Center, Denver, CO N/A COLORADO NETT. The Ohio State University Hospital, Columbus, OH N/A OHIO JCAHO. Ohio State University Medical Center, Columbus, OH N/A OHIO NETT. Saint Louis University, Saint Louis, MO N/A MISSOURI NETT. Temple University Hospital, Philadelphia, PA N/A PENNSYLVANIA NETT. UCLA Medical Center, Los Angeles, CA N/A CALIFORNIA NETT. University of California, San Diego, San Diego, CA N/A CALIFORNIA NETT. University of Maryland Medical Center, Baltimore, MD N/A MARYLAND NETT. University of Michigan Medical Center, Ann Arbor, MI N/A MICHIGAN NETT. University of Pennsylvania, Philadelphia, PA N/A PENNSYLVANIA NETT. University of Pittsburgh, Pittsburgh, PA N/A PENNSYLVANIA NETT. University of Washington, Seattle, WA N/A WASHINGTON NETT. Washington University/Barnes Hospital, Saint Louis, MO N/A MISSOURI NETT. Addendum XV—Medicare-Approved Bariatric Surgery Facilities On February 21, 2006, we issued our decision memorandum on bariatric surgery procedures. We determined that bariatric surgical procedures are reasonable and necessary for Medicare beneficiaries who have a body-mass index

(BMI)greater than or equal to 35, have at least one co-morbidity related to obesity, and have been previously unsuccessful with medical treatment for obesity. This decision also stipulated that covered bariatric surgery procedures are reasonable and necessary only when performed at facilities that are:

(1)Certified by the American College of Surgeons

(ACS)as a Level 1 Bariatric Surgery Center (program standards and requirements in effect on February 15, 2006); or

(2)certified by the American Society for Bariatric Surgery

(ASBS)as a Bariatric Surgery Center of Excellence (BSCOE) (program standards and requirements in effect on February 15, 2006). The following facilities have met our minimum facility standards for bariatric surgery and have been certified by American College of Surgeons

(ACS)or American Society for Metabolic and Bariatric Surgery (ASMBS). Facility name Provider No. Date approved State Other information Evanston Northwestern Hospital, 2650 Ridge Avenue, Suite 1308, Evanston, IL 60201 140010 01/26/2006 IL ACS. Chapman Medical Center, 2601 East Chapman Avenue, Orange, CA 92646 05-0745 02/21/2006 CA ASMBS. St Vincent Carmel Hospital, 13430 Old Meridian Street, Suite 168, Carmel, IN 46032 15-0157 02/21/2006 IN ASMBS. Abbott Northwestern Hospital, 800 E. 28th Street, Minneapolis, MN 55407 N/A 02/24/2006 MN ASMBS. Alexian Brothers Medical Center, 800 Biesterfield Road, Elk Grove Village, IL 60007 N/A 02/24/2006 IL ASMBS. American Bariatric Institute at Doctors' Hospital, 1130 Louisiana Avenue, Shreveport, LA 71101 N/A 02/24/2006 LA ASMBS. Arnot Ogden Medical Center, 600 Fitch Street, Elmira, NY 14905 330090 02/24/2006 NY ASMBS. AtlantiCare Regional Medical Center, 2500 English Creek Avenue, Egg Harbor Township, NJ 08234 N/A 02/24/2006 NJ Center for Surgical Weight Loss and Wellness Salartash Surgical Associates ASMBS. Atlanta Medical Center, 303 Parkway Drive NE, Atlanta, GA 30312 N/A 02/24/2006 GA ASMBS. Aurora Sinai Medical Center, 945 N. 12th Street, Milwaukee, WI 53211 N/A 02/24/2006 WI ASMBS. Baptist Memorial Hospital—North Mississippi, 2301 South Lamar Boulevard, Oxford, MS 38655 N/A 02/24/2006 MS ASMBS. Bellin Health, 215 N. Webster Avenue, Green Bay, WI 54301 N/A 02/24/2006 WI ASMBS. Bon Secours Community Hospital, 160 E. Main Street, Port Jervis, NY 12771 N/A 02/24/2006 NY ASMBS. California Pacific Medical Center, 2333 Buchanan Street, San Francisco, CA 94115 N/A 02/24/2006 CA ASMBS. Cape Fear Valley Health System, 1638 Owen Drive, Fayetteville, NC 28304 N/A 02/24/2006 NC ASMBS. Centennial Center for the Treatment of Obesity, 2300 Patterson Street, Nashville, TN 37203 N/A 02/24/2006 TN ASMBS. Cleveland Clinic Hospital-Weston, 3100 Weston Road, Weston, FL 33331 N/A 02/24/2006 FL ASMBS. Christus Schumpert Health System, 1 Saint Mary Place, Shreveport, LA 71101 N/A 02/24/2006 LA ASMBS. Citizen's Bariatric Center, 2701 Hospital Avenue, Victoria, TX 77901 N/A 02/24/2006 TX ASMBS. Columbia-St. Mary's Bariatric Center, 2025 E. Newport Avenue, Milwaukee, WI 53211 N/A 02/24/2006 WI ASMBS. Community Hospital Monterey Peninsula, 23625 Holman Highway, Monterey, CA 93940 N/A 02/24/2006 CA ASMBS. Crestwood Medical Center, One Hospital Drive, Huntsville, AL 35801 N/A 02/24/2006 AL ASMBS. Cypress Fairbanks Medical Center Hospital, 10655 Steepletop Drive, Houston, TX 77065 450716 02/24/2006 TX ASMBS. Danbury Hospital, 24 Hospital Avenue, Danbury, CT 06810 N/A 02/24/2006 CT ACS. East Texas Medical Center, 1000 S. Beckman Avenue, Tyler, TX 75701 N/A 02/24/2006 TX ASMBS. Eastern Maine Medical Center, 905 Union Street, EMH Mall, Suite 11, Bangor, ME 04401 200033 02/24/2006 ME ASMBS. Elmbrook Memorial Hospital, 19333 W. North Avenue, Brookfield, WI 53045 N/A 02/24/2006 WI ASMBS. Emory Dunwoody Medical Center, 4575 N. Shallowford Road, Atlanta, GA 30338 N/A 02/24/2006 GA ASMBS. Florida Hospital Celebration Health, 400 Celebration Place, Kissimmee, FL 34747 N/A 02/24/2006 FL ASMBS. Florida Medical Center, 4850 W. Oakland Boulevard, Lauderdale Lakes, FL 33313 N/A 02/24/2006 FL ASMBS. Froedtert Memorial Lutheran Hospital, 9200 W. Wisconsin Avenue, Milwaukee, WI 53226 N/A 02/24/2006 WI Medical College of Wisconsin ASMBS. Frye Regional Medical Center, 420 N. Center Street, Hickory, NC 28601 N/A 02/24/2006 NC ASMBS. Geisinger Medical Center, 100 North Academy Avenue, Danville, PA 17822 390006 N/A PA ASMBS-02/24/2006 ACS-01/26/2007. Good Samaritan Hospital, 375 Dixmyth Avenue, Cincinnati, OH 45220 N/A 02/24/2006 OH ASMBS. Grandview Medical Center, 405 Grand Avenue, Dayton, OH 45405 N/A 02/24/2006 OH ASMBS. Greater Baltimore Medical Center, 6701 N. Charles Street, Baltimore, MD 21204 N/A 02/24/2006 MD ASMBS. Hamilton Medical Center, 1200 Memorial Drive, Dalton, GA 30720 N/A 02/24/2006 GA ASMBS. Hennepin County Medical Center, 701 Park Avenue, Minneapolis, MN 55415 N/A 02/24/2006 MN ASMBS. Holy Cross Hospital, 4725 N. Federal Highway, Fort Lauderdale, FL 33308 N/A 02/24/2006 FL ASMBS. Hospital of Saint Raphael, 1450 Chapel Street, New Haven, CT 06511 N/A 02/24/2006 CT ASMBS. Huntington Memorial Hospital, 100 W. California Boulevard, Pasadena, CA 91105 N/A 02/24/2006 CA ASMBS. Jupiter Medical Center, 1210 S. Old Dixie Highway, Jupiter, FL 33458 N/A 02/24/2006 FL ASMBS. King's Daughters Medical Center, 617 23rd Street, Ashland, KY 41101 N/A 02/24/2006 KY ASMBS. Legacy Good Samaritan Hospital and Medical Center, 1015 NW 22nd Avenue, Portland, OR 97210 N/A 02/24/2006 OR ASMBS. Lexington Medical Center, 2720 Sunset Boulevard, West Columbia, SC 29169 N/A 02/24/2006 SC ASMBS. Little Company of Mary, 2800 W. 95th Street, Evergreen Park, IL 60805 N/A 02/24/2006 IL ASMBS. Lutheran Medical Center, 150 55th Street, Brooklyn, NY 11220 29D361 02/24/2006 NY ACS. Medical University of South Carolina, 171 Ashley Avenue, Charleston, SC 29425 N/A 02/24/2006 SC ASMBS. Memorial Hermann Hospital, 6411 Fannin Street, Houston, TX 77030 N/A 02/24/2006 TX ASMBS. Memorial Hospital, 2525 DeSales Avenue, Chattanooga, TN 37404 N/A 02/24/2006 TN ASMBS. Mercy Hospital Miami, 3663 South Miami Avenue, Miami, FL 33133 N/A 02/24/2006 FL ASMBS. Mercy San Juan Medical Center, 6501 Coyle Avenue, Carmichael, CA 95608 N/A 02/24/2006 CA ASMBS. Metabolic Surgery Center at Baptist Hospital, 2011 Church Street, Nashville, TN 37203 N/A 02/24/2006 TN ASMBS. Methodist Dallas Medical Center, PO Box 655999, Dallas, TX 75265-5999 N/A 02/24/2006 TX Texas Bariatric Center ASMBS. Methodist Healthcare System, 8109 Fredricksburg Road, San Antonio, TX 78229 N/A 02/24/2006 TX ASMBS. Methodist Hospital, 6500 Excelsior Boulevard, Saint Louis Park, MN 55426 N/A 02/24/2006 MN ASMBS. Middlesex Hospital, 28 Crescent Street, Middletown, CT 06457 N/A 02/24/2006 CT ASMBS. Methodist Hospital of Southern California, 300 West Huntington Drive, Arcadia, CA 91007 N/A 02/24/2006 CA ASMBS. Mills-Peninsula Health Services, 1783 El Camino Real, Burlingame, CA 94010 N/A 02/24/2006 CA ASMBS. New Hanover Regional Medical Center, 2131 S. 17th Street, Wilmington, NC 28401 N/A 02/24/2006 NC ASMBS. New York Methodist Hospital, 506 Sixth Street, Brooklyn, NY 11215 N/A 02/24/2006 NY ASMBS. North Hills Hospital, 4401 Booth Calloway Road, North Richland Hills, TX 76180 N/A 02/24/2006 TX ASMBS. North Colorado Medical Center, 1801 16th Street, Greeley, CO 80631 N/A 02/24/2006 CO ASMBS. North Vista Hospital, 1409 E. Lake Mead Boulevard, North Las Vegas, NV 89101 N/A 02/24/2006 NV ASMBS. Northeast Georgia Health System, Inc., 743 Spring Street, NE, Gainesville, GA 30501 N/A 02/24/2006 GA ASMBS. NorthEast Medical Center, 920 Church Street N., #302E, Concord, NC 28025 N/A 02/24/2006 NC ASMBS. Northwestern Memorial Hospital, 215 E. Huron Street, NE, Chicago, IL 60611 N/A 02/24/2006 IL Northwestern Medical Faculty Foundation ASMBS. Ocala Regional Medical Center, 1431 SW 1st Street, Ocala, FL 34474 N/A 02/24/2006 FL ASMBS. Palms of Pasadena Hospital, 1501 Pasedena Avenue, St. Petersburg, FL 33707 N/A 02/24/2006 FL ASMBS. Orange Coast Memorial Medical Center, 9920 Talbert Avenue, Fountain Valley, CA 92708 N/A 02/24/2006 CA ASMBS. Parkwest Medical Center, 9352 Park West Boulevard, Knoxville, TN 37923 N/A 02/24/2006 TN ASMBS. Penrose-St. Francis Health Services, 825 E. Pikes Peak Avenue, Colorado Springs, CO 80917 N/A 02/24/2006 CO ASMBS. Poudre Valley Hospital, 1024 S. Lemay Avenue, Fort Collins, CO 80524 N/A 02/24/2006 CO ASMBS. Presbyterian-St. Luke's Medical Center, 1719 E. 19th Avenue, Denver, CO 80218 N/A 02/24/2006 CO ASMBS. Princeton HealthCare System, 253 Witherspoon Street, Princeton, NJ 08540 N/A 02/24/2006 NJ ASMBS. Roger Williams Medical Center, 825 Chalkstone Avenue, Providence, RI 02908 N/A 02/24/2006 RI Drs. Lentrichia & Pohl, Inc. ASMBS. Rose Medical Center, 4545 E. 9th Avenue, #470, Denver, CO 80220 N/A 02/24/2006 CO ASMBS. Saint Barnabas Medical Center, 94 Old Short Hills Road, Livingston, NJ 07039 N/A 02/24/2006 NJ ASMBS. Saint Francis Hospital, 5959 Park Avenue, Memphis, TN 38119 N/A 02/24/2006 TN ASMBS. St. Francis Hospital-Franciscan Health System, 34515 Ninth Avenue S., Federal Way, WA 98003 N/A 02/24/2006 WA N/A. Saint Joseph East Center for Weight Loss, 160 N. Eagle Creek Drive, Lexington, KY 40509 N/A 02/24/2006 KY ASMBS. Saint Mary's Regional Medical Center, 234 W. 6th Street, Reno, NV 89503 N/A 02/24/2006 NV ASMBS. Saint Mary's Hospital, 5801 Bremo Road, Richmond, VA 23226 N/A 02/24/2006 VA ASMBS. Scottsdale Healthcare Shea Campus, 900 E. Shea Boulevard, Scottsdale, AZ 85260 N/A 02/24/2006 AZ ASMBS. Scripps Memorial, 9888 Genesee Avenue, La Jolla, CA 90237 N/A 02/24/2006 CA ASMBS. Scripps Mercy Hospital, 4077 Fifth Avenue, San Diego, CA 92103 N/A 02/24/2006 CA ASMBS. Sentara Careplex Hospital, 3000 Coliseum Drive, Hampton, VA 23666 N/A 02/24/2006 VA ASMBS. Sinai Hospital of Baltimore, 2401 W. Belvedere Avenue, Baltimore, MD 21215 N/A 02/24/2006 MD Sinai Surgical Associates ASMBS. Sisters of Charity Hospital, 2130 Main Street, Buffalo, NY 14214 N/A 02/24/2006 NY ASMBS. Sioux Valley Hospital USD Medical Center, 1305 W. 18th Street, Sioux Falls, SD 57105 N/A 02/24/2006 SD ASMBS. Sound Shore Medical Center of Westchester, 16 Guion Place, New Rochelle, NY 10801 N/A 02/24/2006 NY ASMBS. South Nassau Communities Hospital, 1 Healthy Way, Oceanside, NY 11572 N/A 02/24/2006 NY ASMBS. Southwest Healthcare System, 36485 Inland Valley Drive, Wildomar, CA 92595 N/A 02/24/2006 CA ASMBS. Southwest Medical Center, 2810 Ambassador Caffery Parkway, Lafayette, LA 70506 N/A 02/24/2006 LA ASMBS. Spectrum Health Blodgett Campus, 1840 Wealthy Street, SE, Grand Rapids, MI 49506 N/A 02/24/2006 MI MMPC Center for Health Excellence ASMBS. SSM DePaul Health Center, 12303 DePaul Avenue, Bridgeton, MO 63044 N/A 02/24/2006 MO ASMBS. St. Joseph's Area Health Services, 600 Pleasant Avenue, Park Rapids, MN 56470 N/A 02/24/2006 MN ASMBS. St. Vincent Charity Hospital, 2322 E. 22nd Street, #220, Cleveland, OH 44115 N/A 02/24/2006 OH ASMBS. Staten Island University Hospital, 475 Seaview Avenue, Staten Island, NY 10305 N/A 02/24/2006 NY ASMBS. Theda Clark Medical Center, 200 Theda Clark Medical Plaza, Suite 410, Neenah, WI 54956 000071445 02/24/2006 WI ACS. The Ohio State University Hospital, 410 W. 10th Avenue, Columbus, OH 43210 N/A 02/24/2006 OH ASMBS. The Regional Medical Center at Memphis, 877 Jefferson Avenue, Memphis, TN 38103 N/A 02/24/2006 TN ASMBS. Tri-City Regional Medical Center, 21530 Pioneer Boulevard, Hawaiian Gardens, CA 90716 N/A 02/24/2006 CA ASMBS. United Hospital, 333 North Smith Avenue, Saint Paul, MN 55102 N/A 02/24/2006 MN ASMBS. United Regional Health Care System, 1600 19th Street, Wichita Falls, TX 76301 N/A 02/24/2006 TX ASMBS. Unity Hospital, 550 Osborne Road, NE, Fridley, MN 55432 N/A 02/24/2006 MN ASMBS. University of Chicago Hospitals, 5841 S. Maryland Avenue, Chicago, IL 60637 N/A 02/24/2006 IL University of Chicago Department of Surgery ASMBS. University of Minnesota Medical Center, Fairview, 2450 Riverside Avenue, Minneapolis, MN 55454 24-0080 02/24/2006 MN ASMBS. UPMC St. Margaret, 815 Freeport Road, Pittsburgh, PA 15215 N/A 02/24/2006 PA ASMBS. UPMC Horizon, 110 North Main Street, Greenville, PA 16125 N/A 02/24/2006 PA ASMBS. Virginia Commonwealth University Medical Center Richmond, VA 23284 N/A 02/24/2006 VA ASMBS. Vanderbilt University Medical Center, 1211 22nd Avenue S., Nashville, TN 37232 N/A 02/24/2006 TN ASMBS. Weight Loss Surgery Program at Baylor, 9101 N. Central Expressway, Suite 370, Dallas, TX 75231 N/A 02/24/2006 TX ASMBS. Wellstar Health Systems, 677 Church Street, NE, Marietta, GA 30060 N/A 02/24/2006 GA ASMBS. White Plains Hospital Center, 190 E. Post Road, White Plains, NY 10601 N/A 02/24/2006 NY ASMBSs York Hospital, 1001 S. George Street, York, PA 17403 N/A 02/24/2006 PA ASMBS. Norman Regional Hospital, 901 North Porter, Box 1308, Norman, OK 73070 370008 03/22/2006 OK ASMBS. St. Luke's Medical Center, 1800 E. Van Buren, Suite 307B, Phoenix, AZ 85006 030037 03/22/2006 AZ Abdominal Surgeons, Ltd. ASMBS. Silver Cross Hospital, 1200 Maple Road, Joliet, IL 60432 140213 03/22/2006 IL Midwest Comprehensive Bariatrics ASMBS. Tampa General Hospital, 2 Columbia Drive, F145, Tampa, FL 33601 100128 03/22/2006 FL University of South Florida ASMBS. Spartanburg Regional Healthcare System, 101 East Wood Street, Spartanburg, SC 29303 420007 03/27/2006 SC ASMBS. OSF Saint Francis Medical Center, 530 NE Glen Oak Avenue, Peoria, IL 61637 140067 04/05/2006 IL ASMBS. Palmetto Health Baptist, 1850 Laurel Street, Suite 1A, Columbia, SC 29201 420086 04/05/2006 SC ASMBS. Peconic Bay Medical Center, 1300 Roanoke Avenue, Riverhead, NY 11901 330107 04/06/2006 NY ASMBS. Desert Springs Hospital, 2075 East Flamingo, Las Vegas, NV 89119 290022 04/07/2006 NV ASMBS. Palmetto General Hospital, 2001 West 68th Street, Hialeah, FL 33016 100187 04/11/2006 FL ASMBS. Hurley Medical Center, One Hurley Plaza, Flint, MI 48503-5993 230132 04/14/2006 MI ACS. University of California, Davis, 2315 Stockton Boulevard, Sacramento, CA 95817 N/A 04/18/2006 CA ASMBS. Russell County Medical, Carroll and Tate Streets, Lebanon, VA 24266 N/A 04/27/2006 VA ASMBS. Western Pennsylvania Hospital, 4800 Friendship Avenue, Pittsburgh, PA 15224 028672 N/A PA ASMBS-05/01/2006 ACS-10/16/2006. Banner Good Samaritan Bariatric Center, 1300 North 12th Street, Suite 610, Phoenix, AZ 85006 N/A 05/04/2006 AZ ASMBS. Bothwell Regional Health Center, 601 East 14th Street, Sedalia, MO 65301 N/A 05/17/2006 MO ASMBS. Durham Regional Hospital, 3643 N. Roxboro Road, Durham, NC 27704 N/A 05/17/2006 NC ASMBS. Fairview Southdale Hospital, 6405 France Avenue Street, Suite W320 Edina, MN 55435 N/A 05/17/2006 MN ASMBS. Cleveland Clinic, 9500 Euclid Avenue (A80), Cleveland, OH 44195 360180 N/A OH 05/24/2006-ASMBS 12/01/2006-ACS. St. Agnes Healthcare, 900 Caton Avenue, Baltimore, MD 21229 210011 05/24/2006 MD ASMBS. Sycamore Hospital, 2150 Leiter Road, Miamisburg, OH 45342 360239 05/24/2006 OH ASMBS. Albany Medical Center, 47 New Scotland Avenue, Albany, NY 12208 330013 06/02/2006 NY ACS. Georgetown Community Hospital, 1140 Lexington Road, Georgetown, KY 40324 180101 06/07/2006 KY ASMBS. Fletcher Allen Health Care, 111 Colchester Avenue, Burlington, VT 05401 N/A 06/09/2006 VT Hospital: 470003 Group Provider: VN0997 ACS. New York-Presbyterian Hospital/Columbia University Medical Center, 622 W. 168th Street, New York, NY 10032 330101 06/14/2006 NY ACS. Providence Memorial Hospital, 2001 North Oregon Street, El Paso, TX 79902 450668 06/15/2006 TX ASMBS. UT Southwestern University Hospitals-Zale Lipshy, 5909 Harry Hines Boulevard, Dallas, TX 75390 450766 06/19/2006 TX ASMBS. Cedars-Sinai Medical Center, 8700 Beverly Boulevard, Los Angeles, CA 90048 N/A 06/20/2006 CA Thalians—2W ACS. Community Medical Center-Clovis, 2755 Herndon Avenue, Clovis, CA 93611 050492 N/A CA ACS-06/26/2006 ASMBS-12/07/2006. Oregon Health & Science University, 3181 SW Sam Jackson Park Road, L223A, Portland, OR 97239 See other information 06/27/2006 OR OHSU Medical Group—107708 OHSU Hospital—380009 ACS. Hospital of the University of Pennsylvania, 3400 Spruce Street, 4 Silverstein, Philadelphia, PA 19104 N/A 07/06/2006 PA ASMBS. Swedish Medical Center, 501 East Hampden Avenue, Englewood, CO 80113 060034 07/06/2006 CO ASMBS. Blount Memorial Hospital, 907 East Lamar Alexander Parkway, Maryville, TN 37801 440011 07/11/2006 TN ASMBS. University of Virginia Health System, PO Box 800809, Charlottesville, VA 22908-0809 490009 07/12/2006 VA ACS. Sewickley Valley Hospital, 720 Blackburn Road, Sewickley, PA 15143 390037 07/13/2006 PA ASMBS. The Christ Hospital, 2139 Auburn Avenue, Cincinnati, OH 45219 360163 07/17/2006 OH ASMBS. Cabell Huntington Hospital, 1340 Hal Greer Boulevard, Huntington, WV 25701 510055 07/19/2006 WV ASMBS. Mount Sinai Hospital, One Gustave L. Levy Place, 1190 5th Avenue, New York, NY 10029 330024 07/25/2006 NY ASMBS. UMass Memorial Medical Center—Memorial Campus, 119 Belmont Street, Worcester, MA 01605 A22819 07/27/2006 MA ACS. Henry Ford Hospital, 2799 West Grand Boulevard, Detroit, MI 48202 N/A 07/31/2006 MI ASMMBS. Vista Surgical Hospital, 9094 Perkins Road, Suite B, Baton Rouge, LA 70810 230053 07/31/2006 LA ASMBS. Town & Country Hospital, 6001 Webb Road, Tampa, FL 33615 100255 08/02/2006 FL ASMBS. New York-Presbyterian Hospital/Weill Cornell Medical Center, 630 West 168th Street, New York, NY 10032 330101 08/04/2006 NY ACS. Centinela Freeman Regional Medical Center, 4650 Lincoln Boulevard, Marin del Rey, CA 90292 050741 08/07/2006 CA ASMBS. NYU Medical Center, 560 First Avenue, New York, NY 10016 330214 08/08/2006 NY ASMBS. Regional West Medical Center, 4021 Avenue B, Scottsbluff, NE 69361 280061 08/08/2006 NE ASMBS. Mercy Medical Center, 1000 North Village Avenue, Rockville Centre, NY 11570 N/A 08/10/2006 NY ASMBS. Brigham and Women's Hospital, 75 Francis Street, Boston, MA 02115-6195 M20830 08/14/2006 MA ACS. Highland Hospital, 1000 South Avenue, Rochester, NY 14620 330164 08/30/2006 NY ACS. Inova Fair Oaks Hospital, 3600 Joseph Siewick Drive, Fairfax, VA 22033 490101 08/31/2006 VA ASMBS. Our Lady of Lourdes Medical Center, 1600 Haddon Avenue, Camden, NJ 08104 613039 08/31/2006 NJ ASMBS. FirstHealth Moore Regional Hospital, 155 Memorial Drive, Pinehurst, NC 27374 340115 09/01/2006 NC ASMBS. Hamot Medical Center, 201 State Street, Erie, PA 16550 390063 09/01/2006 PA ASMBS St. Alexius Hospital-NewStart, 3933 South Broadway Street, St. Louis, MO 63118 260210 09/01/2006 MO ASMBS. St. Catherine of Siena Medical Center, 50 Route 25A, Smithtown, NY 11787 316495 09/01/2006 NY ASMBS. Barnes Jewish Hospital, One Barnes-Jewish Hospital Plaza, St. Louis, MO 63110 260032 09/06/2006 MO ASMBS. Baptist Memorial Hospital Memphis, 6025 Walnut Grove Road, Memphis, TN 38120 440048 09/07/2006 TN ASMBS. Norwalk Hospital, 24 Stevens Street, Norwalk, CT 06856 070034 09/07/2006 CT ASMBS. North Shore University Hospital at Manhasset, 300 Community Drive, Manhasset, NY 11530 330106 09/08/2006 NY ASMBS. St. Vincent's Medical Center, 2800 Main Street, Bridgeport, CT 06606 070028 09/08/2006 CT Level 3-Department of Surgery, ASMBS. Faxton-St. Luke's Healthcare, 1656 Champlin Avenue, Utica, NY 13503 330044 09/14/2006 NY ASMBS. St. Joseph's Hospital, 69 West Exchange, St. Paul, MN 55102 N/A 09/14/2006 MN ASMBS. Johns Hopkins Bayview Medical Center, 4940 Eastern Avenue, Baltimore, MD 21224 210029 09/15/2006 MD ASMBS. University Hospitals of Cleveland, 11100 Euclid Avenue, Cleveland, OH 44106 N/A 09/15/2006 OH ASMBS. Yale-New Haven Hospital, 20 York Street, New Haven, CT 06510 070022 09/20/2006 CT ASMBS. Avera McKennan Hospital, 800 East 21st Street, Box 5045, Sioux Falls, SD 57117-5045 430016 09/25/2006 SD ASMBS. Memorial Hospital Jacksonville, 3625 University Boulevard South, Jacksonville, FL 32216 100179 09/26/2006 FL ASMBS. Fountain Valley Regional Hospital, 17100 Euclid Street, Fountain Valley, CA 92708 050570 09/27/2006 CA ASMBS. Sentara Norfolk General Hospital, 600 Gresham Drive, Norfolk, VA 23507 4900073 09/29/2006 VA ACS. St. Mary's Medical Center, 450 Stanyan Street, San Francisco, CA 94117 050457 10/02/2006 CA ASMBS. Trinity Medical Center, 800 Montclair Road, Birmingham, AL 35213 010104 10/03/2006 AL ASMBS. MeritCare Health System, 720 4th Street North, Fargo, ND 58122 350011 10/11/2006 ND ASMBS. St. Lukes's/Roosevelt, 1090 Amsterdam Avenue, New York, NY 10025 330046 10/11/2006 NY 10th Floor, ACS. Benefis Healthcare, 1101 26th Street South, Great Falls, MT 59405 270012 10/13/2006 MT ASMBS. Mason General Hospital, 901 Mountain View Drive, Shelton, WA 98584 501336 10/13/2006 WA ASMBS. Norton Hospital, 200 East Chestnut, Louisville, KY 40202 180088 10/16/2006 KY ASMBS. Port Huron Hospital, 1221 Pine Grove Avenue, Port Huron, MI 48060 230216 10/16/2006 MI ASMBS. Harper University Hospital, 3990 John R. Street, Detroit, MI 48201 230104 10/17/2006 MI ASMBS. St. Luke Hospital, 7380 Turfway Road, Florence, KY 41042 180045 10/18/2006 KY ASMBS. Twelve Oaks Medical Center Hospital, 4200 Twelve Oaks Drive, Houston, TX 77027 N/A 10/18/2006 TX ASMBS. Cleveland Clinic Florida, 3100 Weston Road, Weston, FL 33331-3602 100289 10/19/2006 FL ACS. Grinnell Regional Medical Center, 210 Fourth Avenue, Grinnell, IA 50112 N/A 10/19/2006 IA Provider Numbers: Hospital: 160147, Surgical Group: 03108, ACS. Conway Medical Services, 300 Singleton Ridge Road, Conway, SC 29528 420049 10/20/2006 SC ASMBS. Alta Bates Medical Center, 350 Hawthorne Avenue, Oakland, CA 94609 050043 10/23/2006 CA ASMBS. Massachusetts General Hospital, 55 Fruit Street, Boston, MA 02114-2696 220071 10/23/2006 MA ACS. Mayo Clinic-Saint Mary's Hospital, 200 First Street, SW, Rochester, MN 55905 N/A 10/23/2006 MN SMH: 24-0010, Part B General Medical: C01384, ACS. Saint Francis Hospital, 6465 South Yale Avenue, #900, Tulsa, OK 74136 372308 10/23/2006 OK ACS. Newton-Wellesley Hospital, 2014 Washington Street, Newton, MA 02462 220101 10/26/2006 MA ACS. Mobile Infirmary Medical Center, 5 Mobile Infirmary Circle, Mobile, AL 36007 010113 10/27/2006 AL ASMBS. Maine Medical Center, 22 Bramhall Street, Portland, ME 04102 200009 11/06/2006 ME ASMBS. Magee Womens Hospital of UPMC, 3000 Halket Street, Pittsburgh, PA 15213 390114 11/13/2006 PA ASMBS. Saint Francis Hospital and Medical Center, 114 Woodland Street, Hartford, CT 06105 070002 11/15/2006 CT ASMBS. South Jersey Healthcare-Regional Medical Center, 1505 West Sherman Avenue, Vineland, NJ 08360 310032 11/20/2006 NJ ASMBS. Overlook Hospital, 99 Beauvoir Avenue, Summit, NJ 07902 310051 11/21/2006 NJ Nursing Administration Office, ASMBS. Cedars Medical Center, 1400 Northwest 12th Avenue, Miami, FL 33136 100009 11/23/2006 FL ASMBS. Memorial Hermann Memorial City Hospital, 921 Gessner Road, Houston, TX 77024 450610 11/27/2006 TX ASMBS. Tufts-New England Medical Center, 750 Washington Street, Boston, MA 02111 220116 11/27/2006 MA ASMBS. Allegheny General Hospital, 320 East North Avenue, Pittsburgh, PA 15212 390050 11/30/2006 PA Fifth Floor, South Tower, ASMBS. Northwest Medical Center, 2801 North State Road 7, Margate, FL 33063 100189 11/30/2006 FL ASMBS. Potomac Hospital, 2300 Opitz Boulevard, Woodbridge, VA 22191 490113 11/30/2006 VA ASMBS. Baptist Health Medical Center-Little Rock, 9601 I-630, Exit 7, Little Rock, AR 72205 040114 12/01/2006 AR ASMBS. University of Washington Medical Center, 1959 NE Pacific Street, PO Box 356151, Seattle, WA 98195-6151 1326002049 12/05/2006 WA ACS. St. Luke's Regional Medical Center, 333 North 1st Street, Suite 120, Boise, ID 83702 130006 12/06/2006 ID ASMBS. University of Alabama at Birmingham Hospital, 1530 3rd Avenue South, Kracke Building 404, Birmingham, AL 35294-0016 010033 12/07/2006 AL ACS. Hackensack University Medical Center, 30 Prospect Avenue, Hackensack, NJ 07601 310001 12/08/2006 NJ ACS. Hialeah Hospital, 651 East 25th Street, Hialeah, FL 33013 100053 12/13/2006 FL ASMBS. Sts. Mary and Elizabeth Hospital, 1850 Bluegrass Avenue, Louisville, KY 40215 180040 12/15/2006 KY Bariatric Office, ASMBS. Bon Secours Surgical Weight Loss-Maryview Medical Center, 3636 High Street, Portsmouth, VA 23707 490017 12/18/2006 VA ASMBS. Pomerado Hospital, 15615 Pomerado Road, Poway, CA 92064 050636 12/18/2006 CA ASMBS. Boston Medical Center, 88 E. Newton Street, D507-Department of Surgery, Boston, MA 02118 220031 12/19/2006 MA ACS. Medcenter One, Inc., 300 North 7th Street, Bismarck, ND 58501 350015 12/19/2006 ND ASMBS. Meriter Hospital, 202 South Park Street, Madison, WI 53715 520089 12/19/2006 WI ASMBS. University of Wisconsin Hospital & Clinics, 600 Highland Avenue, Madison, WI 53792 520098 12/19/2006 WI ASMBS. Women and Children's Hospital, 4200 Nelson Road, Lake Charles, LA 70605 190201 12/19/2006 LA ASMBS. Mount Carmel West Hospital, 793 West State Street, Columbus, OH 43222 360035 12/20/2006 OH ASMBS. Southcoast Hospitals Group-Tobey Hospital, 43 High Street, Wareham, MA 02571 220074 12/21/2006 MA ASMBS. Carilion Roanoke Memorial Hospital, 1906 Belleview Avenue, Roanoke, VA 24014 N/A 12/26/2006 VA ASMBS. Mercy General Health Partners, 1500 Sherman Boulevard, Muskegon, MI 49444 230004 12/26/2006 MI ASMBS. Mountainside Hospital, 1 Bay Avenue, Montclair, NJ 07042 310054 12/26/2006 NJ ASMBS. Park Plaza Hospital, 1313 Hermann Drive, Houston, TX 77004 450659 01/09/2007 TX ASMBS. Renaissance Hospital Houston, 2807 Little York, Houston, TX 77093 450795 01/12/2007 TX ASMBS. Penn State Milton S. Hershey Medical Center, 500 University Drive, Hershey, PA 17033 390256 01/18/2007 PA ASMBS. Shawnee Mission Medical Center, 9100 West 74th Street, Shawnee Mission, KS 66204 170104 01/24/2007 KS ASMBS. Morristown Memorial Hospital, 100 Madison Avenue, Morristown, NJ 07962 31-0015 01/25/2007 NJ ACS. Alvarado Hospital, 6655 Alvarado Road, San Diego, CA 92120 050583 01/26/2007 CA Alvarado Surgical Weight-Loss Program, ASMBS. St. Francis Hospital, 7th and Clayton Streets, Wilmington, DE 19805 080003 01/29/2007 DE ASMBS. Sacred Heart Medical Center, 101 West 8th Avenue, Spokane, WA 99220 500054 02/05/2007 WA ASMBS. Ochsner Clinic Foundation, 1514 Jefferson Highway, New Orleans, LA 70121 190036 02/06/2007 LA ASMBS. Northwest Specialty Hospital, 1593 East Polston Avenue, Post Falls, ID 83854 130066 02/07/2007 ID ASMBS. Sacred Heart Hospital, 421 Chew Street, Allentown, PA 18102 390197 02/07/2007 PA ASMBS. Rio Grande Regional Hospital, 101 East Ridge Road, McAllen, TX 78503 450711 02/12/2007 TX ASMBS. Gundersen Lutheran Medical Center, 1900 South Avenue, La Crosse, WI 54601 520087 02/13/2007 WI ASMBS. Kettering Medical Center, 3535 Southern Boulevard, Kettering, OH 45429 360079 02/16/2007 OH ASMBS. Beth Israel Deaconess Medical Center, 330 Brookline Avenue, Boston, MA 02215 N/A 02/17/2006 MA ACS. Shady Grove Adventist Hospital, 9901 Medical Center Drive, Rockville, MD 20850 210057 02/19/2007 MD ASMBS. Pitt County Memorial Hospital, 2100 Stantonsburg Road, Greenville, NC 27835 340040 02/20/2007 NC ASMBS. St. Cloud Hospital, 1406 Sixth Avenue, North, St. Cloud, MN 56303 240036 02/23/2007 MN ASMBS. Virginia Mason Medical Center, 1100 Ninth Avenue, Seattle, WA 98101 500005 03/01/2007 WA ASMBS. Southeast Georgia Health System, 2415 Parkwood Drive, Brunswick, GA 31520 110025 03/06/2007 GA ASMBS. Baystate Medical Center, 759 Chestnut Street, Springfield, MA 01199 220077 03/13/2007 MA ACS. PinnacleHealth Community Campus, 4300 Londonderry Road, c/o PO Box 8700, Harrisburg, PA 17109 390067 03/29/2007 PA ASMBS. The Valley Hospital, 223 North Van Dien Avenue, Ridgewood, NJ 07450 310012 03/30/2007 NJ ASMBS. Charleston Area Medical Center, 800 Pennsylvania Avenue, Charleston, WV 25302 510022 04/16/2007 WV ASMBS. Presbyterian Hospital of Dallas, 8200 Walnut Hill Lane, Dallas, TX 75231 450462 04/16/2007 TX ASMBS. Dekalb Medical Center, 2701 North Decatur Road, Decatur, GA 30033 110076 04/26/2007 GA ASMBS. St. Francis Health Center, 1700 SW 7th Street, Topeka, KS 66606 170016 04/26/2007 KS ASMBS. St. Mark's Hospital, 1200 East 3900 South, Salt Lake City, UT 84124 47007 04/26/2007 UT ASMBS. Faulkner Hospital, 1153 Centre Street, Boston, MA 02130 220119 04/27/2007 MA ACS. George Washington University Hospital, 9000 23rd Street, NW., Washington, DC 20037 090001 08/14/2006 DC ASMBS. William Beaumont Hospital—Royal Oak, 3601 West Thirteen Mile Road, Royal Oak, MI 48073-6769 230130 04/20/2007 MI ACS. University Medical Center at Princeton, 253 Witherspoon Street, Princeton, NJ 08542 N/A 02/24/2006 NJ ASMBS. Del Sol Medical Center, 10201 Gateway West, Suite 130, El Paso, TX 79925 45-0646 05/03/2007 TX ACS. Winchester Hospital, 41 Highland Avenue, Winchester, MA 01890 220105 05/31/2007 MA ASMBS. Lawrence Memorial Hospital—Hallmark Health System, 170 Governors Avenue, Medford, MA 02155 220070 05/31/2007 MA ASMBS. The Methodist Hospital, 6565 Fannin, NB1-001, Houston, TX 77030 450358 03/22/2007 TX ACS. ValleyCare Health System, 1111 East Stanley Boulevard, Livermore, CA 94550 050283 06/07/2007 CA ASMBS. The Presbyterian Hospital, 200 Hawthorne Lane, Charlotte, NC 28204 340053 06/06/2007 NC ASMBS. Nix Hospital, 414 Navarro Street, San Antonio, TX 78205 450130 06/08/2007 TX ASMBS. Huntsville Hospital, 101 Sivley Road, Huntsville, AL 35801 010039 05/11/2007 AL ASMBS. The Jewish Hospital, 4777 Galbraith Road, Cincinnati, OH 45236 360016 06/07/2007 OH ASMBS. UCI Medical Center, 101 The City Drive South, Orange, CA 92868 050348 05/25/2007 CA ACS. Kaiser Permanente Medical Center Richmond, 901 Nevin Avenue, Richmond, CA 94801 050075 05/24/2007 CA ACS. Green Hospital, 12395 El Camino Real, San Diego, CA 92130 050424 06/21/2007 CA ASMBS. Sutter Roseville Medical Center, One Medical Plaza, Roseville, CA 95661 050309 06/22/2007 CA ASMBS. Munroe Regional Medical Center, 1500 Southwest 1st Avenue, Ocala, FL 34471 100062 06/05/2007 FL ASMBS. Enloe Medical Center, 251 Cohasset Road, Chico, CA 95926 050039 06/11/2007 CA ASMBS. St. Francis Hospital & Health Centers, 1600 Albany Street, Beech Grove, IN 46107 150033 06/15/2007 IN ASMBS. Southern Surgical Hospital, 1700 West Lindberg Drive, Slidell, LA 70458 190270 06/21/2007 LA ASMBS. Creighton University Medical Center, 601 North 30th Street, Omaha, NE 68131 280030 06/20/2007 NE ASMBS. Peninsula Regional Medical Center, 100 East Carroll Street, Salisbury, MD 21801 210019 06/20/2007 MD ASMBS. Wadley Regional Medical Center, 1000 Pine Street, Texarkana, TX 75501 450200 06/08/2007 TX ASMBS. Vista Medical Center Hospital, 4301 Vista Road, Pasadena, TX 77504 450831 06/22/2007 TX ASMBS. St. David's Medical Center, 919 East 32nd Street, Austin, TX 78705 450531 06/22/2007 TX ASMBS. Sanford USD Medical Center, 1305 West 18th Street, Sioux Falls, SD 57117 430027 01/17/2006 SD ASMBS. Weight Loss Surgery Program at Baylor, 3600 Gaston Avenue, Suite 360 Wadley Tower, Dallas, TX 75246 N/A 06/20/2007 TX ASMBS. Shelby Baptist Medical Center, 1000 First Street N., Alabaster, AL 35007 010016 05/18/2007 AL ACS. Lehigh Valley Hospital and Health Network, Cedar Crest & I-78, PO Box 689, Allentown, PA 18105-1556 390133 05/29/2007 PA ACS. West Hills Hospital, 7300 Medical Center Drive, West Hills, CA 91307 050481 06/27/2007 CA ASMBS. Adirondack Medical Center, 2233 State Route 86, Saranack Lake, NY 12983 330079 06/26/2007 NY ASMBS. Middletown Regional Hospital, 105 McKnight Drive, Middletown, OH 45044 360076 06/25/2007 OH ASMBS. Kaleida Health, Buffalo General, 100 High Street, Buffalo, NY 14203 300005 06/25/2007 NY ASMBS. Miami Valley Hospital, One Wyoming Street, Dayton, OH 45409 N/A 06/25/2007 OH ASMBS. Minimally Invasive Surgery Hospital, 11217 Lakeview Avenue, Lenexa, KS 66219 N/A 06/25/2007 KS ASMBS. Saint Agnes Medical Center, 1303 E. Herndon Avenue, Fresno, CA 93720 05-0093 07/24/2007 CA ASMBS. Sartori Memorial Hospital, 515 College Street, Cedar Falls, IA 50613 160040 07/17/2007 IA ASMBS. Maimonides Medical Center, 948 48th Street, 2nd floor, Brooklyn, NY 11219 33-0194 07/10/2007 NY ASMBS. Westchester Medical Center, 95 Grasslands Road, Valhalla, NY 10595 330234 07/17/2007 NY ASMBS. Deaconess Hospital, 311 Straight Street, Cincinnati, OH 45219 36-0038 07/17/2007 OH ASMBS. Northern Ohio Bariatric Center at Parma Hospital, 6305 Powers Boulevard, Parma, OH 44129 360041 07/10/2007 OH ASMBS. Einstein at Elkins Park, 60 E. Township Line Road, Elkins Park, PA 19027 390142 07/10/2007 PA ASMBS. Lahey Clinic Medical Center, 41 Mall Road, Burlington, MA 01805 220171 06/22/2007 MA ACS. St. Francis Hospital, 34515 Ninth Ave South, Federal Way, WA 98003 500141 07/26/2007 WA ACS. California Foundation for Health, 1401 Garces Highway, Delano, CA 93215 050608 07/10/2007 CA d.b.a. Delano Regional Medical Center; ASMBS. Northeast Alabama Regional Medical Center, 400 East 10th Street, Anniston, AL 36207 010078 07/30/2007 AL ASMBS. Trinity Medical Center, 4343 N. Josey Lane, Carrollton, TX 75010 45-0730 07/30/2007 TX ASMBS. Gratiot Medical Center, 300 E. Warwick Drive, Alma, MI 48801 23-0030 07/30/2007 MI ASMBS. Cuyuna Regional Medical Center, 320 East Main Street, Crosby, MN 56441 241353 08/20/2007 MN ASMBS. Valley Medical Center, 400 South 43rd Street, Renton, WA 98055 500088 07/30/2007 WA ASMBS. Renaissance Hospital Dallas, 427 W. 20th Street, Suite 300, Houston, TX 77008 670002 08/08/2007 TX ASMBS. UPMC Presbyterian Shadyside, 5230 Centre Avenue, Pittsburgh, PA 15232 39-0114 08/20/2007 PA ASMBS. Clarian North Medical Center, 6625 Network Way, Suite 100, Indianapolis, IN 46202 15-0161 08/20/2007 IN ASMBS. Genesis Medical Center, 1227 East Rusholme Street, Davenport, IA 52803 160033 08/08/2007 IA ASMBS. University General Hospital, 7501 Fannin Street, Houston, TX 77054 670019 08/08/2007 TX ASMBS. Ellis Hospital, 1101 Nott Street, Schenectaday, NY 12308 330153 06/19/2007 NY ASMBS. University of Texas Medical Branch, 301 University Boulevard, Galveston, TX, 77555-1168 450018 08/16/2007 TX ACS. UPMC Presbyterian Shadyside, 5230 Centre Avenue, Pittsburgh, PA 15232 39-0114 08/20/2007 PA ABMS. Christiana Care Health Services, 4755 Ogletown—Stanton Road, Newark, DE 19718 080001 08/29/2007 DE ASMBS. Stanford Hospital and Clinics, 300 Pasteur Drive, Stanford, CA 94305 050441 09/13/2007 CA ACS. Summa Health Systems Hospital, 95 Arch Street, Suite 240, Akron, OH 44304 360020 09/21/2007 OH ASMBS. Memorial Regional Hospital, 3500 Johnson Street, Hollywood, FL 33021 100038 09/11/2007 FL ASMBS. Temple University Hospital, 3401 North Broad Street, Philadelphia, PA 19140 390027 09/21/2007 PA ASMBS. Good Samaritan Hospital, 2425 Samaritan Drive, San Jose, CA 95124 50380 09/21/2007 CA ASMBS. Johnson City Medical Center, 400 North State of Franklin Road, Johnson City, TN 37604 HSP440063 09/27/2007 TN ASMBS. Providence Saint Joseph Medical Center, 201 South Buena Vista Street, Suite 425, Burbank, CA 91505 50235 N/A CA ASMBS-09/17/2007; ACS-09/05/2007. Baptist Bariatric Center of Excellence, 1000 West Moreno Street, Pensacola, FL 32501 10-0093 09/27/2007 FL ASMBS. Hillcrest Hospital, 2104 Woodruff Road, Greenville, SC 29607 43-0037 10/10/2007 SC ASMBS. Fairway Medical, 67252 Industry Lane, Covington, LA 70433 190267 10/10/2007 LA ASMBS. John T. Mather Memorial Hospital, 75 North Country Road, Port Jefferson, NY 11777 JTM 33-0185 10/10/2007 NY ASMBS. Lenox Hill Hospital, 110 East 59th Street, Suite 8A, New York, NY 10022 10003F8 10/10/2007 NY ASMBS. Easton Hospital, 250 South 21st Street, Easton, PA 18042 390162 10/10/2007 PA ASMBS. Medical City Dallas Hospital, 7777 Forest Lane, Suite 240A, Dallas, TX 75230 000340 10/10/2007 TX ASMBS. St Vincent's East, 50 Medical Park East Drive, Birmingham, AL 35235 010011 10/10/2007 AL ASMBS. Northside Hospital, 1000 Johnson Ferry Road, Atlanta, GA 30342 11-0161 10/10/2007 GA ASMBS. Missouri Bariatric Services, 1000 W. Nifong Boulevard, Building 2, Suite 210, Columbia, MO 65203 000011108 10/10/2007 MO ASMBS. Presbyterian Hospital of Plano, 6200 West Parker Road, Plano, TX 75093 45-0771 10/10/2007 TX ASMBS. Norton Suburban Hospital, 315 East Broadway, Louisville, KY 40202 180088 10/10/2007 KY ASMBS. Sky Ridge Medical Center, 10101 RidgeGate Parkway, Lone Tree, CO 80124 060112 10/30/2007 CO ASMBS. St. Mary Medical Center, 1050 Linden Avenue, Long Beach, CA 90813 050191 10/30/2007 CA ASMBS. Scott and White Hospital, 2401 S. 31st Street, Temple, TX 76508 450054 10/24/2007 TX ACS. The Methodist Hospitals, Inc., 303 East 89th Avenue, Merrillville, IN 46410 150132 10/30/2007 IN ASMBS. Parkview Community Hospital, 3865 Jackson Street, Riverside, CA 92503 050102 10/30/2007 CA ASMBS. Evergreen Hospital, 12040 NE 128th Street, Kirkland, WA 98034 500124 10/30/2007 WA ASMBS. University of Maryland, Medical Center, 22 South Greene Street, Baltimore, MD, 21201-1595 21002 11/05/2007 MD ACS. Montefiore Medical Center, 111 East 210th Street, Bronx, NY 10467 330059 11/07/2007 NY Group #: 330059, Dr. Karen Gibbs #: 140341, Dr. Pratibha Vemulapalli #: 3097H1; ACS. Emory Crawford Long Hospital, 1364 Clifton Road, NE, Atlanta, GA 30322 110078 11/13/2007 GA ACS. El Camino Hospital, 2500 Grant Road, Mountain View, CA 94039 050308 11/19/2007 CA ASMBS. Northeast Baptist Hospital, 8811 Village Drive, San Antonio, TX 78217 450058 11/19/2007 TX ASMBS. University of Iowa Hospitals and Clinics, 4624 JCP Bariatric Surgery, Iowa City, IA 52242 160058 11/19/2007 IA ASMBS. El Camino Hospital, 2500 Grant Road, Mountain View, CA, 94039 050308 11/19/2007 CA ASMBS. Aspirus Wausau Hospital, 333 Pineridge Boulevard, Wausau, WI 54401 52-0030 11/28/2007 WI ASMBS. Eastern Idaho Regional Medical Center, 2860 Channing Way, Suite 102, Idaho Falls, ID 83404 13-0018 12/10/2007 ID ASMBS. Mount Sinai Medical Center, 4701 North Meridian Avenue, Miami Beach, FL 33140 10-0034 12/11/2007 FL ASMBS. North Florida Regional Medical Center, 6400 Newberry Road, Suite 106, Gainesville, FL 32605 21536 12/27/2007 FL ASMBS. Baylor Regional Medical Center at Plano, 470 Alliance Boulevard, Plano, TX 75093 45-0890 01/04/2008 TX ASMBS. Memorial Medical Center, 1800 Coffee Road, Suite 30, Modesto, CA 95350 050557 01/04/2008 CA ASMBS. Pennsylvania Hospital, 800 Spruce Street, 2 Cathcart, Philadelphia, PA 19107 39-0226 01/08/2008 PA ASMBS. Houston Northwest Medical Center, 710 FM 1960 Road West, Houston, TX 77090 450638 01/08/2008 TX ASMBS. St. Bernadine Medical Center, 2101 North Waterman Avenue, San Bernadino, CA 92404 05-0129 01/04/2008 CA ASMBS. UCLA Medical Center, 10833 Le Conte Avenue, CHS 72-236, Los Angeles, CA 90095 050262 01/08/2008 CA ASMBS. Lourdes Medical Center Burlington County, 218-A Sunset Road, Willingboro, NJ 08046 310061 01/30/2008 NJ ASMBS. Sacred Heart Medical Center, 1200 Hilyard Street, Suite S-570, Eugene, OR 97401 380033 01/23/2008 OR ASMBS. Salt Lake Regional Medical Center, 1050 East South Temple, Salt Lake City, UT 84102 460003 02/11/2008 UT ASMBS. Kaiser Permanente-South San Francisco, 1200 El Camino Real, South San Francisco, CA 94080 050070 01/30/2008 CA ASMBS. Chilton Memorial Hospital, 97 West Parkway, Pompton Plains, NJ 07444 310017 02/12/2008 NJ ASMBS. Mary Imogene Bassett Hospital, One Atwell Road, Cooperstown, NY 13326 330136 02/12/2008 NY ASMBS. Sharp Memorial Hospital, 7901 Frost Street—5 South /ACC, San Diego, CA 92123 0150100 02/11/2008 CA ASMBS. Doctors Hospital at White Rock Lake, 9440 Poppy Drive, Dallas, TX 75218 450678 01/30/2008 TX ASMBS. Rhode Island Hospital, 2 Dudley Street, Suite 470, Providence, RI 02905 410007 02/25/2008 RI ASMBS. Munson Medical Center, 1105 Sixth Street, Traverse City, MI 49684 23-0097 02/19/2008 MI ASMBS. DayOne Health at 900 N. Michigan Surgical Center, 409 West Huron, Suite 300, Chicago, IL 60613 538810 02/19/2008 IL ASMBS. USC University Hospital, 1500 San Pablo, Los Angeles, CA 90033 05-0696 01/30/2008 CA ASMBS. Lexington Medical Center, 2720 Sunset Boulevard, West Columbia, SC 29169-4810 See other information 01/14/2008 SC ACS; NPI: Hospital Services 1356366314; Professional Services 1144248097. Saint Clare's Hospital, 400 West Blackwell Street, Dover, NJ 07801 310050 03/17/2008 NJ ASMBS. Hartford Hospital, 85 Seymour Street, Suite 415, Hartford, CT 06106 07-0025 03/25/2008 CT ASMBS. Singing River Hospital, 2809 Denny Avenue, Pascagoula, MS 39581 250040 03/17/2008 MS ASMBS. St. John's Regional Health Center, 1235 East Cherokee Street, Springfield, MO 65804 260065 03/17/2008 MO ASMBS. Willis Knighton Health System, 2551 Greenwood Road, Suite 340, Shreveport, LA 71103 190111 03/17/2008 LA ASMBS. Cottage Health System, PO Box 689 Pueblo at Bath Street, Santa Barbara, CA 93102-0689 030596 02/25/2008 CA ASMBS. Syosset Hospital, 221 Jericho Turnpike, Syosset, NY 11791 330106 02/19/2008 NY ASMBS. The Hospital of Central Connecticut, 1000 Grand Street, New Britain, CT 06050 070035 03/11/2008 CT ASMBS. Stringfellow Memorial Hospital, 105 Windsor Lane, Rainbow City, AL 35906 01-0038 03/11/2008 AL ASMBS. Providence Alaska Medical Center, 3200 Providence Drive, Anchorage, AK 99519-6604 02-0001 03/17/2008 AK ASMBS. The Reading Hospital and Medical Center, 2603 Keiser Boulevard, Wyomissing, PA 19610 390044 03/25/2008 PA ASMBS. Good Samaritan Hospital, 255 Lafayette Avenue, Suffern, NY 10901 330158 03/25/2008 NY ASMBS. San Joaquin Community Hospital, 2819 H Street, Bakersfield, CA 93301 04055 04/01/2008 CA ASMBS. Lowell General Hospital, 295 Varnum Avenue, Lowell, MA 01854 02/22/2008 MA Medicare: 220063; Medicaid Inpatient #: 100228; Medicaid Outpatient #: 1201069; ACS. Memorial Health University Medical Center, 4700 Waters Avenue, Savannah, GA 31404 11-0036 04/08/2008 GA ASMBS. Abington Memorial Hospital, 1235 Old York Road, Suite G-28, Abington, PA 19001 390231 04/21/2008 PA ASMBS. Christiana Care Health Services, 3506 Kennett Pike, Wilmington, DE 19807 080001 04/18/2008 DE ACS. Addendum XVI—FDG-PET for Dementia and Neurodegenerative Diseases Clinical Trials In a National Coverage Determination for fluorodeoxyglucose positron emission tomography (FDG-PET) for Dementia and Neurodegenerative Diseases (220.6.13) we indicated that an FDG-PET scan is considered reasonable and necessary in patients with mild cognitive impairment or early dementia only in the context of an approved clinical trial that contains patient safeguards and protections to ensure proper administration, use, and evaluation of the FDG-PET scan. Facility name Provider No. Date approved State Name of trial Principal investigator UCLA Medical Center, 10833 Le Conte Avenue, Los Angeles, CA 90095 HW13029 06/07/2006 CA Early and Long-Term Value of Imaging Brain Metabolism Dr. Daniel Silverman. Santa Monica-UCLA Medical Center, 1245 16th Street, Suite 105, Santa Monica, CA 90404 W11817A 01/12/2007 CA N/A N/A. University of Buffalo, 3435 Main Street, Buffalo, NY 14214 14414A 03/12/2007 NY Metabolic Cerebral Imaging in Incipient Dementia (MCI-ID) Dr. Daniel Silverman. [FR Doc. E8-13110 Filed 6-26-08; 8:45 am] BILLING CODE 4120-01-P 73 125 Friday, June 27, 2008 Proposed Rules Part III Department of Health and Human Services Centers for Medicare & Medicaid Services 42 CFR Parts 405, 410, and 491 Medicare Program; Changes in Conditions of Participation Requirements and Payment Provisions for Rural Health Clinics and Federally Qualified Health Centers; Proposed Rule DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Medicare & Medicaid Services 42 CFR Parts 405, 410, and 491 [CMS-1910-P2] RIN 0938-AJ17 Medicare Program; Changes in Conditions of Participation Requirements and Payment Provisions for Rural Health Clinics and Federally Qualified Health Centers AGENCY: Centers for Medicare & Medicaid Services (CMS), HHS. ACTION: Proposed rule. SUMMARY: This proposed rule would establish location requirements including exception criteria for rural health clinics (RHCs). It would also require RHCs to establish a quality assessment and performance improvement

(QAPI)program. In addition, it would: Clarify our policies on “commingling” of an RHC with another entity; revise the RHC and Federally Qualified Health Centers

(FQHC)payment methodology and exceptions to the per-visit payment limit to implement statutory requirements; revise RHC and FQHC payment requirements for services furnished to skilled nursing facility

(SNF)patients; allow RHCs to contract with RHC nonphysician providers under certain circumstances; and update the regulations pertaining to waivers to the staffing requirements. This proposed rule would also add requirements for RHCs and FQHCs to maintain and document an infection control process and to post RHC or FQHC hours of clinical services. In addition, this proposed rule would update the requirements under the emergency services standard and patient health records condition for certification

(CfC)to reflect advancements in technology and treatment. Finally, this proposed rule solicits comments on payment for high cost drugs and the appropriateness of a mental health specialty clinic as an exception to the location requirements. DATES: To be assured consideration, comments must be received at one of the addresses provided below, no later than 5 p.m. on August 26, 2008. ADDRESSES: In commenting, please refer to file code CMS-1910-P2. Because of staff and resource limitations, we cannot accept comments by facsimile

(FAX)transmission. You may submit comments in one of four ways (please choose only one of the ways listed): 1. *Electronically.* You may submit electronic comments on this regulation to *http://www.regulations.gov* . Follow the instructions for “Comment or Submission” and enter the CMS-1910-P2 to find the document accepting comments. 2. *By regular mail.* You may mail written comments (one original and two copies) to the following address ONLY: Centers for Medicare & Medicaid Services, Department of Health and Human Services, Attention: CMS-1910-P2, P.O. Box 8010, Baltimore, MD 21244-8010. Please allow sufficient time for mailed comments to be received before the close of the comment period. 3. *By express or overnight mail.* You may send written comments (one original and two copies) to the following address ONLY: Centers for Medicare & Medicaid Services, Department of Health and Human Services, Attention: CMS-1910-P2, Mail Stop C4-26-05, 7500 Security Boulevard, Baltimore, MD 21244-1850. 4. *By hand or courier.* If you prefer, you may deliver (by hand or courier) your written comments (one original and two copies) before the close of the comment period to either of the following addresses: a. Room 445-G, Hubert H. Humphrey Building, 200 Independence Avenue, SW., Washington, DC 20201. (Because access to the interior of the HHH Building is not readily available to persons without Federal Government identification, commenters are encouraged to leave their comments in the CMS drop slots located in the main lobby of the building. A stamp-in clock is available for persons wishing to retain a proof of filing by stamping in and retaining an extra copy of the comments being filed.) b. 7500 Security Boulevard, Baltimore, MD 21244-1850. If you intend to deliver your comments to the Baltimore address, please call telephone number

(410)786-7195 in advance to schedule your arrival with one of our staff members. Comments mailed to the addresses indicated as appropriate for hand or courier delivery may be delayed and received after the comment period. *Submission of comments on paperwork requirements.* You may submit comments on this document's paperwork requirements by following the instructions at the end of the “Collection of Information Requirements” section in this document. For information on viewing public comments, see the beginning of the SUPPLEMENTARY INFORMATION section. FOR FURTHER INFORMATION CONTACT: Corinne Axelrod,

(410)786-5620. Rural health clinic location requirements and exceptions, staffing and payment. Mary Collins,

(410)786-3189 and Scott Cooper

(410)786-9465. Quality assessment and performance improvement and health and safety standards. SUPPLEMENTARY INFORMATION: *Inspection of Public Comments:* All comments received before the close of the comment period are available for viewing by the public, including any personally identifiable or confidential business information that is included in a comment. We post all comments received before the close of the comment period on the following Web site as soon as possible after they have been received: *http://www.regulations.gov* . Follow the search instructions on that Web site to view public comments. Comments received timely will also be available for public inspection as they are received, generally beginning approximately 3 weeks after publication of a document, at the headquarters of the Centers for Medicare & Medicaid Services, 7500 Security Boulevard, Baltimore, Maryland 21244, Monday through Friday of each week from 8:30 a.m. to 4 p.m. To schedule an appointment to view public comments, phone 1-800-743-3951. Abbreviations and Acronyms AED—Automated External Defibrillator BBA—Balanced Budget Act of 1997 BIPA—Medicare, Medicaid, and SCHIP Benefits Improvement and Protection Act of 2000 CAH—Critical Access Hospital CDC—Centers for Disease Control and Prevention CfC—Condition for Certification CMS—Centers for Medicare & Medicaid Services CNM—Certified Nurse-Midwife CNS—Clinical Nurse Specialist CoP—Condition of Participation CP—Clinical Psychologist CSW—Clinical Social Worker DRA—Deficit Reduction Act DSMT—Diabetes Self-Management Training FI—Fiscal Intermediary FQHC—Federally Qualified Health Center GAO—Government Accountability Office GDSC—Governor-Designated and Secretary-Certified Shortage Areas HHS—Department of Health and Human Services HPSA—Health Professional Shortage Area HRSA—Health Resources and Services Administration MAC—Medicare Administrative Contractor MMA—Medicare Prescription Drug, Improvement, and Modernization Act of 2003 MUA—Medically Underserved Area MUP—Medically Underserved Population NP—Nurse Practitioner OBRA—Omnibus Budget Reconciliation Act OIG—Office of the Inspector General OMB—Office of Management and Budget PA—Physician Assistant PHS—Public Health Service PPS—Prospective Payment System PRA—Paperwork Reduction Act QAPI—Quality Assessment and Performance Improvement RFA—Regulatory Flexibility Act RHC—Rural Health Clinic RO—Regional Office RUCA—Rural Urban Commuting Area SCHIP—State Children's Health Insurance Program SNF—Skilled Nursing Facility UA—Urbanized Area UIC—Urban Influence Code USDA—United States Department of Agriculture Table of Contents I. Background A. Publication and Suspension of the December 24, 2003 Final Rule B. Summary of Provisions of the December 24, 2003 Final Rule C. Origin of the RHC/FQHC Programs D. Growth of the RHC Program 1. Continuing Participation 2. Medically Underserved/Shortage Area Designations 3. Expansion of Eligible Designations for RHC Certification 4. Commingling E. Government Reports on RHCs II. Provisions of This Proposed Rule A. RHC Location Requirements and Exceptions 1. RHC Location Requirements 2. Essential Provider Requirements 3. Location Exception Criteria 4. Process for Essential Providers Status and Timeline B. Staffing Requirements, Waivers, and Contracts 1. Staffing Requirements 2. Temporary Staffing Waivers 3. Contractual Arrangements C. Payment Issues 1. Payment Methodology for RHC and FQHCs 2. Exceptions to the Per Visit Payment Limit 3. Commingling 4. Payment for Services to Hospital Patients 5. Payment for Services to Skilled Nursing Facility

(SNF)Patients 6. Payment for Certain Physician Assistant Services 7. Screening Mammography 8. Payment for High Cost Drugs D. Health and Safety, and Quality 1. Quality Assessment & Performance Improvement Program

(QAPI)2. Infection Control 3. Hours of Operation a. Posting of Hours b. Use of the RHC Facility 4. Emergency Services and Training 5. Patient Health Records E. Other Proposed Changes 1. General 2. FQHCs III. Collection of Information Requirements IV. Regulatory Impact Analysis Regulation Text I. Background A. Publication and Suspension of the December 24, 2003 Final Rule On February 28, 2000, we published a proposed rule in the **Federal Register** (65 FR 10450) entitled “Rural Health Clinics: Amendments to Participation Requirements and Payment Provisions; and Establishment of a Quality Assessment and Performance Improvement Program.” This proposed rule revised certification and payment requirements for rural health clinics

(RHCs)as required by the Balanced Budget Act of 1997 (BBA), Public Law 105-33, enacted on August 5, 1997. We issued the final RHC rule on December 24, 2003 (68 FR 74792). On December 8, 2003, the Medicare Prescription Drug, Improvement, and Modernization Act of 2003

(MMA)(Pub. L. 108-173) was enacted. Section 902 of the MMA amended section 1871(a) of the Social Security Act (the Act) and requires the Secretary, in consultation with the Director of the Office of Management and Budget (OMB), to establish and publish timelines for the publication of Medicare final regulations based on the previous publication of a Medicare proposed or interim final regulation. Section 902 of the MMA also states that “[s]uch timeline may vary among different regulations based on differences in the complexity of the regulation, the number and scope of comments received, and other relevant factors, but shall not be longer than 3 years except under exceptional circumstances.” To comply with the MMA requirement to publish a final rule not more than 3 years after a proposed rule, we suspended the effectiveness of the December 24, 2003 final rule on September 22, 2006 (71 FR 55341). The Code of Federal Regulations currently reflects the regulations in effect before December 2003. While section 902 of the MMA did not explicitly prohibit the Secretary from finalizing all proposed rules that were published as an interim or proposed rule more than 3 years before December 8, 2003, we chose to take this opportunity to propose additional updates and clarifications of the provisions published in the previous rule, and provide the public with the opportunity to comment on these proposals. B. Summary of the Provisions of the December 24, 2003 Final Rule The December 24, 2003 final rule addressed comments received on the February 28, 2000 proposed rule, and finalized policies regarding RHC and federally qualified health center

(FQHC)payment and participation in the Medicare program. It established:

(1)Criteria and a process to decertify RHCs which no longer serve rural or medically underserved areas (MUAs), as required by the BBA;

(2)a policy that would have prohibited the commingling of RHC resources with another entity's resources; and

(3)a requirement that RHCs establish a quality assessment and performance improvement

(QAPI)program. The December 24, 2003 final rule also updated payment policies and regulations to conform to statutory requirements of the Omnibus Budget Reconciliation Acts

(OBRA)'86, '87, '89, and '90 and the MMA. For the reasons specified in section I.A. of this proposed rule, these provisions have been suspended. C. Origin of the RHC/FQHC Programs The Rural Health Clinic Services Act of 1977 (Pub. L. 95-210) enacted on December 13, 1977, amended the Act by adding section 1861(aa) of the Act to extend Medicare and Medicaid entitlement and payment for primary and emergency care services furnished at an RHC by physicians and certain “nonphysician practitioners,” and for services and supplies incidental to their services. “Nonphysician practitioners” included nurse practitioners

(NPs)and physician assistants (PAs). (Subsequent legislation extended the definition of covered RHC services to include the services of clinical psychologists (CPs), clinical social workers (CSWs), and certified nurse-midwives (CNMs).) According to House Report No. 95-548(I), the purpose of the Rural Health Clinic Services Act was to address an inadequate supply of physicians serving Medicare beneficiaries and Medicaid recipients in rural areas. The legislation addressed this problem by authorizing CMS and States to pay qualifying clinics on a cost-related basis for providing Medicare beneficiaries and Medicaid recipients, respectively, with outpatient physician and certain nonphysician services. (The Medicare payment provisions for RHCs are in sections 1833(a)(3) and 1833(f) of the Act and in regulations at § 405.2462 through § 405.2468.) Payment to RHCs for services furnished to beneficiaries is made on the basis of an all-inclusive payment methodology subject to a maximum payment per-visit and annual reconciliation. Qualifying clinics, among other criteria, must be located in an area that is determined to be nonurbanized by the U.S. Census Bureau. The clinic also must be located in an area designated as a shortage area either by the Health Resources and Services Administration

(HRSA)or by the chief executive officer of the State and certified by the Secretary, Department of Health and Human Services (HHS). (See section 1861(aa)(2) of the Act, following subparagraph (K).) Qualifying clinics also must employ a PA or NP and, to meet requirements of the OBRA '89, must have a NP, a PA, or a CNM available to furnish patient care services at least 5.0 percent of the time the RHC operates. The FQHC Medicare coverage and payment benefit was provided for in OBRA '90, Public Law 101-508, enacted on November 5, 1990, and implemented in the **Federal Register** (57 FR 24961) on June 12, 1992. On April 3, 1996, we published a final regulation (61 FR 14640) that addressed the issues raised by commenters on the June 1992 rule. OBRA '90 defines an FQHC as an entity that is receiving a grant under section 329, section 330, or section 340 of the Public Health Service Act (PHS). The definition of an FQHC was expanded by section 13556(a)(3) of OBRA '93 (Pub. L. 103-66) enacted on August 10, 1993, effective as if included in OBRA '90 on October 1, 1991. The expanded definition included outpatient programs or facilities operated by a tribal organization under the Indian Self-Determination Act, or by an urban Indian organization receiving funds under Title V of the Indian Health Care Improvement Act. The FQHC scope of benefits for core services is similar to the RHC benefit, that is, physician, nonphysician practitioner, and mental health professional services. The FQHC benefit also includes a number of preventive services. Each FQHC is reimbursed its reasonable costs based on an all-inclusive per-visit methodology subject to tests of reasonableness, and is subject to an overall payment limit similar to RHCs. The national FQHC payment limit is based on the costs of providing primary care physician and prevention services. For FQHC services, there are two upper payment limits: One limit is for centers located in urban areas and the other is for centers located in rural areas. D. Growth of the RHC Program The RHC program has grown from less than 1,000 Medicare-approved RHCs in 1992 to more than 3,700 in 2008. However, since 2001, growth in the program has leveled off. While part of this increase has improved access to primary care services in rural areas for Medicare beneficiaries and Medicaid recipients, there are instances in which these additional RHCs have not expanded access. 1. Continuing Participation A significant factor in the growth of RHCs stems from the original (pre-BBA) RHC legislation, which included a “grandfather clause” to promote the development of RHCs. (See section 1(e) of the Health Clinic Services Act of 1977 (Pub. L. 95-210) enacted December 13, 1977, 42 U.S.C. 1395x note. Also see § 491.5(b)(2) of the regulations.) Section 1861(aa)(2) of the Act stated that any RHC that subsequently failed to satisfy the requirements pertaining to the rural and underserved location requirement still would be deemed to have satisfied the requirement of that clause. These provisions protected the clinics' RHC status regardless of any changes to the rural or underserved status of the service areas. It allowed clinics to remain in the RHC program even though the service areas no longer were considered rural or medically underserved. The Congress established these protections to encourage clinics to attract needed health care professionals to underserved rural areas and to retain them without being concerned about losing the shortage area designation, which would make the clinics ineligible for RHC status and its reimbursement incentives. Once the clinic successfully attracted the needed health care professionals to the area, the Congress wanted to ensure that the service area did not return to its previous underserved status because we removed the clinic's RHC status and reimbursement incentives. Although the grandfather clause provision was an appropriate policy at the time, we now have RHC participation in some service areas with extensive health care delivery systems that provide adequate access to primary care for Medicare beneficiaries and Medicaid recipients. Both the Government Accountability Office

(GAO)and the HHS Office of the Inspector General

(OIG)recommended the establishment of a mechanism, under the survey and certification process for Medicare facilities, to discontinue RHC status and its payment incentives in those service areas where they are no longer justified. In section 4205(d)(3) of the BBA, the Congress responded to these recommendations by amending the grandfather clause provision to provide protection only to clinics essential to the delivery of primary care in the respective service area. 2. Medically Underserved/Shortage Area Designations Another reason for the continued growth of the RHC program was that two of the types of shortage area designations that are used for RHC certification, the medically underserved area

(MUA)and the Governor-Designated Secretary-Certified Shortage Area

(GDSC)designations, did not have a statutory requirement for regular review and were not reviewed systematically and updated after their initial designation. As a result, some RHCs are in areas that no longer would be designated as underserved if reviewed with current data. In response, the Congress amended the legislation in section 4205(d) of the BBA by requiring that only those clinics located in shortage areas that were designated or updated within the previous 3 years would qualify for purposes of the RHC program. 3. Expansion of Eligible Designations for RHC Certification Section 6213 of OBRA '89 amended section 1861(aa)(2) of the Act to expand the types of shortage areas eligible for RHC certification. Until then, the eligible areas included only those designated by the Secretary as areas having a shortage of personal health services under section 330(b)(3) of the PHS Act (medically underserved areas (MUAs)) and those designated as geographic health professional shortage areas (HPSAs) under section 332(a)(1)(A) of the PHS Act. The OBRA '89 amendment expanded the eligible areas to also include: high impact migrant areas designated under section 329(a)(5) of the PHS Act; areas containing a population group HPSA designated under section 332(a)(1)(B) of the PHS Act; and areas designated by the Governor of a State and certified by the Secretary as having a shortage of personal health services. However, later, the Health Centers Consolidation Act of 1996 (Pub. L. 104-299) renumbered section 329 of the PHS Act and repealed the requirement for designation of high impact migrant areas. 4. Commingling The growth of RHCs may have also been stimulated by the practice of “commingling.” The term “commingling” is used to describe the sharing of RHC space, staff, supplies, records, or other resources with a private Medicare practice or other entity operated by the same physician and nonphysician practitioners working for the RHC, during RHC hours of operation. We recognize that providing care in rural areas that have limited infrastructure and providers requires the coordination of scarce resources, and permit the sharing of resources in certain situations. In some of these situations, however, it is believed that commingling has been used to maximize Medicare payment by obtaining RHC status for an integrated practice that submits both RHC and non-RHC Medicare claims. E. Government Reports on RHCs The GAO report, “Rural Health Clinics: Rising Program Expenditures Not Focused on Improving Care in Isolated Areas” (GAO/HHS-97-24, November 22, 1996), and the HHS/IG report “Rural Health Clinics: Growth, Access and Payment” (OEI-05-94-00040, July 1996), both concluded that the growth of RHCs is not proportional to community need and that many RHCs no longer require cost-based reimbursement as a payment incentive. They also concluded that the payment methodology for provider-based RHCs lacks sufficient cost controls and recommended establishing payment limits and screens on reasonable costs for these providers. (A provider-based RHC is an integral and subordinate part of a Medicare participating hospital, critical access hospital (CAH), skilled nursing facility (SNF), or home health agency (HHA), and is operated with other departments of the provider under common governance, professional supervision, and usually licensure. All other RHCs are considered to be independent.) In August 2005, the OIG issued a followup report, “Status of the Rural Health Clinic Program” (OEI-05-03-00170), which recommended that HRSA review shortage designations within the requisite 3-year period and publish regulations to revise its shortage designation criteria. The report also suggested that CMS issue regulations to:

(1)Ensure that RHCs determined to be essential providers remain certified as RHCs; and

(2)require prospective RHCs to document need on access to health care in rural underserved areas. II. Provisions of This Proposed Rule A. RHC Location Requirements and Exceptions 1. RHC Location Requirements In sections 4205(d)(1) and

(2)of the BBA, the Congress amended section 1861(aa)(2) of the Act. As revised, the statute states that RHCs may include only a facility which is located in:

(1)A nonurbanized area, as defined by the U.S. Census Bureau;

(2)an area in which there are an insufficient number of needed health care practitioners as determined by the Secretary; and

(3)an area that has been designated or certified by the Secretary within the previous 3 years as having an insufficient number of needed health care practitioners. Section 4205(d)(3)(A) of the BBA, which amended the third sentence of section 1861(aa)(2) of the Act, revised the “grandfather clause” that permitted an exception to the termination of RHC status for a clinic located in an area that is no longer a rural area or a shortage area. This revision specified that an exception was available only if the RHC was determined to be essential to the delivery of primary care services that would otherwise be unavailable in the geographic area served by the RHC. These amendments were made effective upon issuance of implementing regulations that the Congress directed CMS to issue by January 1, 1999. The BBA requirement that every RHC must have a current shortage area designation (made or updated within the previous 3-year period), has been implemented for new RHCs through administrative instructions. To determine if a facility is in a nonurbanized area, we propose that the most recently available U.S. Census Bureau list of Urbanized Areas

(UA)be used. An area that is not in a UA would be considered a nonurbanized area. Information on whether an area is urbanized can be found at *http://factfinder.census.gov* or by contacting the appropriate CMS Regional Office

(RO)at *http://www.cms.hhs.gov/RegionalOffices* . To determine if a facility is in an area that has a current designation as an underserved or shortage area, the most current HRSA list of these designations would be used. Information on designation status, including the date of the most recent designation or update, is available on the HRSA Web site at *http://hpsafind.hrsa.gov/* and *http://muafind.hrsa.gov* or by contacting the appropriate CMS RO. Health professional shortage area

(HPSA)and MUA designations establish initial eligibility for Federal and State programs to improve access to health care services. They are based on established criteria (42 CFR part 5) to identify geographic areas or population groups with a shortage of primary health care services. HPSA designations are based primarily on the population to provider ratio in a defined service area. MUA designations utilize an Index of Medical Underserviced which calculates a score for each area based on a weighted combination of the ratio of primary medical care physicians per 1,000 population, infant mortality rate, percentage of the population with incomes below the poverty level, and percentage of the population age 65 or over. ( **Note:** HRSA has proposed a revision of the methodology used for determining HPSA and MUA designations. If necessary, this description of the designations will be updated in the final rule. Any change that HRSA makes to the methodology used to determine designations will not alter the requirements for the RHC program.) Any of the following types of designations are acceptable for the purpose of RHC certification and compliance with this proposed requirement: • Geographic Primary Care HPSAs (section 332(a)(1)(A) of the PHS Act) • Population-group Primary Care HPSAs (section 332(a)(1)(B) of the PHS Act) • MUAs (This does not include population group Medically Underserved Population designations) (Section 330(b)(3) of the PHS Act) • Governor-designated and Secretary-certified shortage areas. (section 6213(c) of OBRA '89 (Pub. L. 101-239)) In section 302(a)(1)(A) of the Health Care Safety Amendments of 2002 (Pub. L. 107-251, October 26, 2002), the Congress amended section 332 of the PHS Act to create a new type of HPSA designation for FQHCs and RHCs referred to as an “automatic” HPSA designation. This type of designation is available to any RHC or FQHC irrespective of its physical location that utilizes sliding scale fees consistent with section 330 of the PHS Act for the purpose of National Health Service Corps eligibility. Facilities with these automatic HPSA designations are sometimes referred to as “safety net facilities.” However, we are proposing not to include the automatic HPSA designations as an eligible shortage area for purposes of Medicare qualifications as an RHC. Section 1861(aa)(2) of the Act specifically requires RHCs to be located in one of four specified designation types in which the Secretary has determined that there are insufficient numbers of needed practitioners. Consequently, we would not recognize automatic HPSA designations for purposes of RHC certification or protecting a currently participating clinic from RHC decertification. New and existing RHCs would have to be in a rural area that is currently designated as one of the four types of shortage areas listed previously. A designation is considered current for not more than 3 years after the date of the original designation or the date of the most recent update to the designation. An existing RHC that no longer meets would not be decertified based on the loss of its shortage area designation if:

(1)A complete designation application has been received by HRSA before the end of the 3-year period since the shortage area designation date or most recent update; or

(2)we have determined that the RHC is an essential provider. If either of these conditions is not met, the clinic would be terminated from participation in the Medicare program as an RHC 180 days after the date that the RHC no longer meets the location requirements, effective the last day of the month. States are encouraged to submit designation applications and updates to HRSA in a timely manner and may apply or reapply for a designation at any time. 2. Essential Provider Requirements The RHC program was established for the purpose of improving and maintaining access to primary care for rural underserved communities. RHCs that apply to CMS for an exception to the location requirements must be able to show that they satisfy this program objective. In accordance with section 1861(aa)(2) of the Act, an existing RHC may be considered essential to the delivery of primary care (a so-called “essential provider”) if the care otherwise would be unavailable in the geographic area served by the clinic. The Secretary is directed by the Act to set the criteria by which “essential provider” status is to be determined. The Secretary has determined that an RHC may be considered an essential provider and be granted an exception to the location requirements if the clinic is no longer in a nonurbanized area or it is no longer in a currently designated shortage area, and it meets the criteria of an essential provider. An RHC that is neither in a rural area nor a designated area would not be considered an essential provider. Proposed criteria for essential provider status were published in the February 2000 proposed rule and have been revised based on comments that were received and other relevant information. Under this authority, we are proposing the following requirements for essential provider status: If an RHC is located in an area that has been classified as a UA by the U.S. Census Bureau, it would have to be in a level 4 or higher Rural Urban Commuting Area

(RUCA)to assure that it is in a rural area. Under section 330A of the PHS Act, HRSA's Office of Rural Health Policy determines eligibility for its rural grant programs through the use of the RUCA code methodology. Under this methodology, any census tract that is in a RUCA level 4 or higher is determined to be a rural census tract. For the purposes of an exception to the RHC nonurbanized area location requirement, we would use the RUCA level 4 as the minimum level of rurality to meet this requirement. Additionally, an RHC that is located in an area that has been classified as a UA by the U.S. Census Bureau would have to demonstrate that at least 51 percent of its patients reside in an adjacent nonurban area in order to be considered essential for the purposes of an exception to the location requirements. We prefer to give RHCs flexibility in establishing that at least 51 percent of their patients reside in an adjacent nonurban area; however, this could generally include the identification of the nonurban area(s) and a retrospective review of patient visits to determine residence, or other factors to support that the requirement has been met. 3. Location Exception Criteria We are proposing to revise § 491.5 to specify that an RHC that meets the previously stated requirements may apply for an exception if it meets any one of the following criteria: • *Sole Community Provider (proposed § 491.5(c)(1)):* The RHC is the only participating primary care provider that meets either of the following requirements: ++ The RHC is at least 25 miles from the nearest participating primary care provider; or ++ The RHC is at least 15 miles but less than 25 miles from the nearest participating primary care provider and can demonstrate that it is more than 30 minutes from the nearest primary care provider based on local topography, predictable weather conditions, or posted speed limits. (These criteria are based on the criteria established for sole community hospitals in § 412.92.) For purposes of this exception, a participating primary care provider would mean another RHC, FQHC, or primary care provider that is actively accepting and treating Medicare beneficiaries, Medicaid recipients, low-income patients, and the uninsured (regardless of their ability to pay). • *Major Community Provider (proposed § 491.5 (c)(2)):* The RHC meets the following requirements: ++ Has a Medicare, Medicaid, low-income, and uninsured patient utilization rate greater than or equal to 51 percent, or a low-income patient utilization rate greater than or equal to 31 percent; and ++ Is actively accepting and treating a major share of Medicare, Medicaid, low-income and uninsured patients (regardless of their ability to pay) compared to other participating primary care providers that are within 25 miles of the RHC. • *Specialty Clinic: Obstetrics/Gynecology (Ob/Gyn) or Pediatrics (proposed § 491.5(c)(3)):* The RHC meets the following requirements: ++ Exclusively provides ob/gyn or pediatric health services (as applicable). ++ Is the sole or major source of ob/gyn or pediatrics for Medicare (where applicable), Medicaid, and uninsured patients (regardless of their ability to pay) and is either of the following: —At least 25 miles from the nearest participating provider of ob/gyn or pediatric services. —At least 15 miles but less than 25 miles from the nearest participating provider of ob/gyn or pediatric services, and can demonstrate that it is more than 30 minutes from the nearest participating primary care provider providing these services based on local topography, predictable weather conditions, or posted speed limits. ++ Is actively accepting and treating Medicare, Medicaid, low-income, and uninsured patients. ++ Has a Medicare, Medicaid, low-income patient and uninsured utilization rate greater than or equal to 31 percent. ++ Provides ob/gyn (including prenatal care) or pediatric services onsite to clinic patients. • *Extremely Rural Community Provider (Proposed § 491.5(c)(4)):* The RHC meets the following requirements: ++ Is actively accepting and treating Medicare, Medicaid, low-income, and uninsured patients (regardless of their ability to pay). ++ Is located in a frontier county (a county with 6 or less persons per square mile) or in census tract or zip code with a RUCA code 10. In the December 2003 final rule, we included RHC's that are mental health specialty clinics as an acceptable category for an exception to the location requirements. However, section 1861(aa)(2)(iv) of the Act prohibits RHC status from being applied to clinics which are “primarily for the care and treatment of mental diseases.” We interpret “primarily” to mean that mental health services provided by the RHC cannot constitute more than 50 percent of the total services provided by the RHC. In order to assure that the regulation and statue are consistent, we are asking for comments on—(1) whether it is appropriate to allow an exception to the location requirements for RHCs based on the provision of mental health services in light of the fact that RHC status cannot be granted to a facility providing more than 50 percent of its total services in mental health; and

(2)if so, what should be the minimum level of mental health services provided in order to qualify for an exception. This would apply only to existing an RHC that no longer meet the location requirements, either because it is no longer in a non-urbanized area, or because it is no longer designated by HRSA as an underserved or shortage area. Existing RHCs that are in compliance with the location requirements may continue to provide mental health services as long as the mental health services provided do not exceed 50 percent of the total clinic services. 4. Process for Essential Provider Status and Timeline An RHC that is located in

(a)an area that has not been designated or its designation was not been updated for more than 3 years, or

(b)an urbanized area that is defined by the Census Bureau, would have 90 calendar days from the effective date of the final rule to apply to CMS RO for an exception to the location requirement. The RHC may continue to operate as an RHC for an additional 90 days, for a total of 180 calendar days after the end of the 3-year period. To assist with the cost reporting and payment reconciliation process, decertification would be effective on the last day of the month in which the 180-day limit was met. An RHC would have 180 days after the date that it does not meet the location requirements to continue operating as an RHC. We expect that most RHCs that do not meet the location requirements would want to know as soon as possible if they would receive an exception to the location requirements and would want as much time as possible to make other arrangement for the provision of services after the 180 days, so it is in the interest of the RHC to apply for an exception to the location requirements as soon as possible. An RHC which is located in an area which has been found by HRSA to no longer qualify for one of the 4 types of eligible designations would have 90 calendar days from the date HRSA determined that the area no longer qualified for one of the eligible designations to apply to CMS RO for an exception from decertification. This would include designations that are proposed for withdrawal, as well as areas whose designations type has changed to one that does not meet the RHC criteria. For example, if HRSA determines on April 1, 2009, that the area no longer qualifies for one of the designations required for RHC purposes, the RHC would have until June 30, 2009 to submit an application to the appropriate RO for a location exception, and would be protected until September 30, 2009 from decertification based on not meeting the location requirements. An RHC which is located in an area whose designation has not been updated in a timely manner and which does not apply for a location exception may continue to operate as an RHC for 180 calendar days after the 3 years from the date of the last designation, effective the last day of the month. An RHC may be decertified 180 days after the 3-year date of the area's designation if it does not provide a complete application for a location exception within 90 days from the date it no longer meets the location requirements, or if the application for a location exception is not approved. In rare circumstances, the RO may request an extension from the CMS Central Office if it has not been possible to process the location exception request before the RHC would be decertified. For example, (see accompanying sample timeline) if an area was designated (either a new designation or an update) on January 2, 2006 (#1 on sample timeline), the designation would be considered valid for RHC purposes for 3 years, which would be January 2, 2009 (#2). If an application to update the designation is submitted to HRSA by January 2, 2009 (#3), the RHC would be protected from decertification while the HPSA application is under review (#3.1). If the area qualifies as a HPSA and is updated (#3.2), then no further action would be needed for purposes of the RHC designation for 3 years from the date of the designation update (#3.3). If a HPSA application is submitted by January 2, 2009 (#3), but is determined to not qualify as a HPSA (#3.1.1), then the RHC would have 90 days from the date of that determination to submit an application for an exception (#3.1.2). If an application to update the designation is not submitted to HRSA by January 2, 2009 (#4), the RHC would have until April 3, 2009 (#4.1), to submit an application for a location exception. If the RHC does not submit an application for a location exception to CMS by April 3, 2009 (#4.2), it would be decertified on July 31, 2009 (#4.3). (Decertification is effective the final day of the month.) An RHC that submits an application for a location exception would be protected from decertification while the application is under review (#5). If the application is approved (#5.1), then no further action would be needed for purposes of the RHC recertification for 3 years from the date of the exception (#5.1.1). If the application is not approved (#5.2), the RHC would be decertified 90 days from the date of notification that the application was not approved (#5.2.1). The process to appeal a denial of certification is described in § 498.3(b)(5). For the purpose of an appeal, RHCs and FQHCs are considered suppliers, not providers. In the December 24, 2003 final rule, we stated that an RHC would have 120 days from the date of notification that it was no longer in a designated area and therefore not compliant with the RHC requirements to submit an application to update its MUA or HPSA designation. Although HRSA regulations do not preclude RHCs from submitting a designation application, it is usually the State not the RHC that submits the designation application. The State should not wait until a designation is more than 3 years old to prepare and submit an update for RHC purposes. As noted previously, an existing RHC is protected from decertification based on its designation status as long as an application has been submitted for an updated designation. We encourage RHC to work with the applicable State Primary Care Office to assure that any necessary information is provided to HRSA in a timely manner. A list of the State Primary Care Offices is available online at *http://hrsa.gov/grants* and then by selecting “HRSA Grantees by Program or State” and then by selecting “State Primary Care Offices”, or by contacting the State's Department of Health. An RHC that chooses to apply for an exception to the location requirements would send its application with the necessary documentation to the appropriate RO. An RHC that applied for an exception would not be disqualified as an RHC based on not meeting the location requirements while its application is under review. If approved, the exception would be for a period of 3 years. Every 3 years, an RHC may reapply for an exception to the location requirements to continue its RHC eligibility. Some provider-based RHCs that do not meet the location requirements and do not qualify for an exception may want to continue to operate as another type of Medicare provider. In some cases, these entities will need to go through the standard Medicare application process, which includes an application and, for entities wishing to enroll as a “provider of services” under 1861(u), a state survey. We have been informed that the waiting time for a state survey can be several months, so we are proposing that provider-based RHCs that do not meet the location requirements and do not qualify for an exception and have submitted an application to CMS to be another type of Medicare provider that requires a State survey for certification may receive an additional 120-day extension of their status as an RHCs while their application is being processed. We propose to revise § 491.2 to redefine “shortage areas” as geographic and population group HPSAs, MUAs, and areas designated by the Governor of the State and certified by the Secretary. We propose to amend § 491.3 as follows by adding paragraphs (a)(1) through (a)(3) to specify general certification requirements, and (b)(1) to specify permanent and mobile unit requirements. We propose to amend § 491.5 as follows: • Adding paragraphs (a)(1) through (a)(3) to specify the location requirements for RHCs and FQHCs. • Adding paragraph (a)(4) to specify when a clinic would be terminated from the RHC program. • Adding paragraphs (a)(5) and (a)(6) to specify the requirements for being considered an essential provider. • Adding paragraph (a)(7) to specify the time period for a clinic's essential provider status. • Adding paragraph (a)(8) to specify the time period that a decertified RHC may continue to operate. • Adding paragraph (a)(9) to specify that conditions for an extension of RHC status when the location requirements are not met and the clinic does not qualify for an exception. • Adding paragraphs (b)(1) through (b)(4) to specify the criteria for an exception from the location requirements. • Adding paragraphs (c)(1) and (c)(2) to specify the conditions for termination. • Adding paragraphs (d)(1) through (d)(8) to set forth the circumstances and timeline for submitting a request for an exception to the location requirements. BILLING CODE 4120-01-P EP27JN08.006 BILLING CODE 41210-01-C B. Staffing Requirements, Waivers, and Contracts 1. Staffing Requirements One of the goals of the RHC program is to encourage the use of nonphysician practitioners to provide quality health care in rural areas. We propose to amend § 491.8(a)(6) to conform with section 6213(a)(3) of OBRA '89 (Pub. L. 101-239) which requires that an NP, PA, or CNM be available to furnish patient care at least 50 percent of the time the RHC operates. An RHC that opens its premises solely to address administrative matters or to allow patients shelter from inclement weather would not be considered to be in operation as an RHC during that period. 2. Temporary Staffing Waivers We propose to amend § 491.8(d) to conform with section 1861(aa)(7) of the Act, which authorizes us to grant a 1-year waiver of staffing requirements for nonphysician primary care providers (NPs, PAs, or CNMs) upon request from the RHC. The requesting RHC would have to demonstrate that it made a good faith effort to recruit and retain an adequate number of nonphysician primary care providers, and that it has been unable in the 90-day period prior to the request to hire one of these providers to meet the staffing requirement. This could include activities such as advertising in a newspaper, advertising in a professional journal, conducting outreach to an NP, PA, or CNM school, or other activities that would demonstrate a good faith effort to recruit and retain a nonphysician primary care provider. In accordance with section 1861(aa)(7)(B) of the Act, this waiver would be available only to existing RHCs that meet the nonphysician primary care requirement before seeking the waiver. Section 1861(aa)(7) of the Act also specifies that an additional waiver cannot be granted until a minimum of 6 months has passed since the expiration of the previous waiver. We are proposing that an RHC that has not complied with staffing requirements for one or more nonphysician primary care providers and has not submitted a request for a waiver of this requirement would be decertified from the RHC program. The decertification would be mandatory, since the noncompliant facility would fail to meet the statutory definition of an RHC. An RHC that has submitted a waiver request would not be decertified based on this requirement while its request was under review. A waiver would be deemed granted after 60 days, unless written notification is provided that the request has been denied. An RHC that is decertified from the RHC program due to failure to meet the staffing requirements would no longer be eligible to operate as an RHC. However, the RHC could apply to become a physician-directed clinic, group practice, or a group of individual practitioners who would then bill Medicare using the Part B fee-for-service system. 3. Contractual Arrangements Due to the difficulty in recruiting and retaining physicians in rural areas, RHCs have had the option of hiring physicians either as RHC employees or as contractors. However, in order to promote stability and continuity of care, the Rural Health Clinic Services Act of 1977 required RHCs to “employ a physician assistant or nurse practitioner” (section 1861(aa)(2)(iii) of the Act). We note that the term “employee” is defined in section 3121(d)(2) of the Internal Revenue Code of 1986 and is usually evidence by the employer's provision of a W-2 form to the employee. Our current regulations at § 405.2468(b)(1) state that “ * * * (RHCs are not paid for services furnished by contracted individuals other than physicians).” In the more than 30 years since this legislation was enacted, the health care environment has changed dramatically, and RHCs have requested that they be allowed to enter into contractual agreements with PAs and NPs as well as physicians. To provide RHCs with greater flexibility in meeting their staffing requirements, we propose to revise § 405.2468(b)(1) by removing the parenthetical “RHCs are not paid for services furnished by contracted individuals other than physicians.” Also, we propose to revise § 491.8(a)(3) to state that nonphysician practitioners may furnish services under contract to an RHC within the statutory limits. RHCs would still be required, under section 1861(aa)(2)(iii) of the Act, to employ a PA or NP. However, as long as there is at least one PA or NP employed at all times (subject to the waiver provision set forth at section 1861(aa)(7) of the Act), an RHC would be free to enter into employment contracts with other PAs, NPs, or other nonphysician staff. FQHCs already have the option to contract with PAs and NPs. Authority to allow contracting for clinical services is provided for in the PHS Act. The authority to allow Medicare participating FQHCs to contract with any necessary health professional for the purpose of treating their patients is further clarified by section 5114 of the Deficit Reduction Act of 2005

(DRA)(Pub. L. 109-171) which amended section 1842(b)(6) of the Act to require consolidated billing of contracted professional services by adding new subsection

(H)with the following language: “in the case of services described in section 1861(aa)(3) of the Act that are furnished by a health care professional under contract with a Federally qualified health center, payment shall be made to the center.” Similar language regarding contracted medical professionals was also added to section 1861(aa)(3) of the Act. FQHCs and RHCs also have authority to claim the costs of such contracted practitioners' services on the Medicare cost report to receive Medicare payment. A practitioner providing services under contract to the RHC or FQHC should have a signed contract that includes his or her responsibilities and requirements. All practitioners should be familiar with the clinic or center's policies and procedures, and comply with the staffing requirements in § 491.8. Practitioners should be employed or contracted to the RHC in a manner that enhances continuity and quality of care. We propose to remove the parenthetical statement at § 405.2468(b)(1) which states that RHCs are not paid for services furnished by contracted individuals other than physicians. We also propose to revise § 491.8(a)(3) to state that nonphysician practitioners may furnish services under contract to an RHC. C. Payment Issues 1. Payment Methodology for RHCs and FQHCs Payment to RHCs and FQHCs for covered services furnished to Medicare beneficiaries is made on the basis of an all-inclusive rate per visit, subject to a payment limit. The Medicare Administrative Contractor

(MAC)or FI determines the all-inclusive rate in accordance with this subpart and instructions issued by CMS. With the exception of services provided under Medicare Advantage plans to RHCs and FQHCs, the statutory payment requirements for RHC and FQHC services are set forth at section 1833(a)(3) of the Act, (as amended by the MMA), which states that RHCs and FQHCs are paid reasonable costs “* * * less the amount a provider may charge as described in clause of section 1866(a)(2)(A), but in no case may the payment exceed 80 percent of such costs[.]” The beneficiary is responsible for the Medicare Part B deductible (except for services provided in FQHCs, where there is no Part B deductible) and coinsurance amounts. Section 1866(a)(2)(A)(ii) of the Act and implementing regulations at § 405.2410(b) establish beneficiary coinsurance at an amount not to exceed 20 percent of the clinic's reasonable charges for covered services. Section 237(c) of the MMA which pertains to cost sharing permitted under MA organizations, revised section 1857(e) of the Act. These changes were addressed in § 405.2469 as part of the CY 2006 Physician Fee Schedule final rule with comment period (70 FR 70116). In general, the statutory payment methodology requires that except for services provided under MA plans to FQHCs in accordance with section 1833(a)(3)(B) of the Act, RHCs and FQHCs subtract beneficiary coinsurance and deductible amounts, as applicable (based on reasonable charges) from reasonable costs to determine the Medicare payment. The statute further stipulates that Medicare reimbursement may not exceed 80 percent of reasonable costs. Until now, Medicare has been paying RHCs and FQHCs 80 percent of the facility's reasonable costs, regardless of deductible and coinsurance amounts billed to Medicare beneficiaries. This allowed RHCs and FQHCs to receive, in some instances, payment in excess of 100 percent of reasonable costs. Therefore, to conform existing regulations to the statutory payment methodology described above, we propose to revise § 405.2410 and § 405.2466(b)(1)(iii) by stipulating that, except for services provided under MA plans to FQHCs, Medicare payment is equal to reasonable costs less aggregate coinsurance and deductible amounts billed, but in no case may total Medicare payment exceed 80 percent of reasonable costs. Note: Payment for the outpatient treatment of mental, psychoneurotic, or personality disorders is subject to the limitations on payment in § 410.155 ). 2. Exceptions to the Per Visit Payment Limit Prior to the BBA, the payment methodology for an RHC depended on whether it was “provider-based” or “independent.” Payment to provider-based RHCs for services furnished to Medicare beneficiaries was made on a reasonable cost basis by the provider's FI in accordance with our regulations at 42 CFR part 413. Payment to independent RHCs for services furnished to Medicare beneficiaries was made on the basis of a uniform all-inclusive rate payment methodology in accordance with 42 CFR part 405, subpart X. Payment to independent RHCs also was subject to a maximum payment per visit as set forth in section 1833(f) of the Act. Section 4205(a) of the BBA amended section 1833(f) of the Act. Under the BBA, the independent RHC all-inclusive payment methodology and payment limit were applied to provider-based RHCs. This BBA provision also provided an exception to the RHC payment limit for those RHCs based in small, rural hospitals to help them remain financially viable. Section 224 of the Medicare, Medicaid, and SCHIP Benefits Improvement and Protection Act of 2000

(BIPA)(Pub. L. 106-554) enacted on December 21, 2000, expanded to RHCs based in small, urban hospitals the eligibility criteria for receiving an exception to the RHC payment limit, effective July 1, 2001. This was implemented through a program memorandum on December 6, 2001. If an RHC is an integral and subordinate part of a hospital, it can receive an exception to the per visit payment limit if the hospital has fewer than 50 beds as determined by using one of the following methods: • The determination of the number of beds at § 412.105(b); or • The hospital's average daily patient census count of those beds described in § 412.105(b), and the hospital meets all of the following conditions: ++ It is a sole community hospital as determined in accordance with § 412.92 or § 412.109(a). ++ It is located in a level 9 or 10 RUCA. ++ It has an average daily patient census that does not exceed 40. The December 24, 2003 final RHC rule used the 1993 Urban Influence Codes (UICs), then a 9-category measure developed by the U.S. Department of Agriculture (USDA), to identify hospitals which are located in sparsely populated rural areas. Hospitals with a level 8 or 9-level UIC and which have an average daily census of less than 50 patients would qualify for an exception to the RHC per visit payment limit. The USDA has since changed the UICs to a 12-category measure, with levels 9 through 12 comparable to the 1993 levels 8 and 9. The UICs are a county-level measurement. Since many counties encompass large geographical areas with significant variations in population density, demographics, economics, and health care services, the UICs do not always provide an accurate assessment of a local area's degree of rurality. The RUCA system is another method for identifying rural areas. RUCA codes classify U.S. census tracts using measures of population density, urbanization, and daily commuting. This classification uses 10 numbers with subdivisions to reflect commuting flows. RUCAs are used by CMS for purposes of determining rurality in the hospital and ambulance payment systems. To target the needs of rural populations more accurately and to be consistent with other CMS programs, we propose to utilize the RUCA methodology instead of the UIC methodology. We also propose that RUCA codes 9 and 10 be used for the purpose of approving an exception to the per visit payment limit. We propose to amend § 405.2462 to provide payment to all RHCs and FQHCs on the basis of an all-inclusive rate per visit, subject to the per-visit payment limit. For a hospital-based RHC that is the primary source of health care in its rural community as defined at § 412.92(a) or § 412.109(a), we propose to utilize the hospital's average daily census rather than bed count in determining whether RHC services are subject to the per-visit payment limit. We also propose to utilize RUCAs 9 and 10 to determine eligibility for an exception to the per visit payment limit. 3. Commingling Commingling refers to the sharing of RHC space, staff (employees or contractors), supplies, records, and other resources with an onsite Medicare Part B or Medicaid fee-for-service practice operated by the same RHC physician(s) or nonphysician practitioner(s) or both. Commingling is prohibited when it results in duplicate Medicare or Medicaid reimbursement, either due to the inability of the RHC to distinguish its actual costs from those that are reimbursed on a fee-for-service basis, or due to other reasons. An RHC and a Medicare fee-for-service practice may not operate simultaneously in order to prohibit these shared practices from selecting patient encounters for enhanced Medicare Part B billing. However, an RHC that is part of a multipurpose clinic may house other entities (such as private medical practices, x-ray and lab clinics, dental clinics, emergency room) in the non-RHC space. The entities occupying the non-RHC space may bill the assigned Medicare Administrative Contractor (MAC), Fiscal Intermediary (FI), or carrier as appropriate; authority is delegated to the MAC, FI, or carrier to determine acceptable accounting methods for allocation of staff costs between the RHC and other entities to be used in documenting allocation of costs. Since in a multipurpose clinic the RHC may share some resources in common with the non-RHC entity (for example, waiting room or receptionist), the RHC must maintain accurate records to assure that the RHC costs that it claims for Medicare reimbursement are only for the staff, space, or other resources that are used for RHC purposes. Any shared staff, space, or other resources must be allocated appropriately between the RHC and non-RHC usage to avoid duplicate reimbursement. This commingling policy does not prohibit a hospital-based RHC from sharing its health care practitioners with the hospital emergency department in an emergency, or prohibit an RHC physician from providing on-call services for an emergency room, as long as the RHC continues to meet the RHC conditions for certification

(CfCs)in the absence of the practitioner(s) and the RHC is able to allocate appropriately the practitioner's salary between RHC and non-RHC time. Facilities are encouraged to work with their MAC, FI, or carrier and RO in determining permissible resource-sharing situations and proper cost reporting methods. 4. Payment for Services to Hospital Patients The hospital inpatient bundling provision was enacted on April 20, 1983 in section 602(e)(3) of the Social Security Act Amendments of 1983 (Pub. L. 98-21), by adding paragraph (a)(14) to section 1862 of the Act. The hospital outpatient bundling provision was enacted in section 9343(c) of OBRA '86, Public Law 99-509. Taken together, these two provisions require bundling of the costs for all nonprofessional services furnished to hospital patients. Consequently, section 1862(a)(14) of the Act now requires hospitals and CAHs to bundle all costs, other than those for the professional services specified in the statute. Only professionals exempt from the hospital bundling provisions are permitted to bill for services furnished to hospital patients. RHCs and FQHCs cannot bill for services furnished by RHC practitioners to hospital patients because RHC and FQHC services are not exempt from the hospital bundling provisions. Accordingly, any costs incurred by an RHC or FQHC associated with the provision of services to hospital patients must be excluded from RHC or FQHC allowable costs on their Medicare cost report. However, a practitioner who provides services in an RHC or FQHC may, in some cases, also have a private practice and be enrolled and qualified to bill Medicare under that practice as a Part B practitioner. In these situations, the practitioner may be able to bill Medicare Part B under their private practice for covered services provided to hospital patients. Section 1862(a)(14) of the Act places restrictions on the payment for services furnished to hospital and CAH patients. We propose to revise § 405.2411(b) and

(c)to specify that RHC services are covered when furnished in an RHC setting or other outpatient setting, but are not covered when furnished in a hospital or CAH. 5. Payment for Services to Skilled Nursing Facility

(SNF)Patients Section 4432(b) of the BBA amended the statute to add a consolidated billing provision for SNFs in section 1862(a)(18) of the Act. Similar to the hospital bundling provision in section 1862(a)(14) of the Act, this provision bundled all Part B services furnished to SNF residents during a covered Part A stay into the SNF Prospective Payment System

(PPS)rates, except those services specifically excluded under statute. RHC services were not among the excluded services. Although the Congress excluded physician services and several other services from the SNF bundle of services, RHC and FQHC services were not among the services on the excluded under section 1888(e)(2)(A)(ii) of the Act. Consequently, through program instructions to Medicare contractors (PM A-99-8, March 1999), we announced that under the statute, RHC and FQHC services furnished to SNF residents were subject to the SNF consolidated billing provision and could not be billed to Medicare by the RHC or FQHC. However, section 410 of the MMA amended section 1888(e)(2)(A) of the Act by adding a new paragraph

(iv)to exclude RHC and FQHC services from the SNF consolidated billing provision. This MMA change was effective for services furnished on or after January 1, 2005. In accordance with this section of the MMA, services included within the scope of RHC and FQHC services described at section 1888(e)(2)(A)(ii) of the Act are excluded from the SNF consolidated billing provision. These services are limited to physician, PA, NP, CP, and CNM services. Only this subset of RHC and FQHC services may be covered and paid through the RHC and FQHC benefit when furnished to RHC and FQHC patients in a Medicare Part A covered SNF stay. Payment for this subset of services is made in the usual manner under the RHC and FQHC all-inclusive payment methodology. All services other than physician, PA, NP, CP, and CNM services that an RHC or an FQHC may furnish to a patient in a Medicare covered Part A SNF stay are subject to the SNF consolidated billing provision. This means any costs associated with these other services are excluded from coverage and payment under the RHC and FQHC benefit when furnished to a Part A SNF patient. We propose to require in § 405.2411(b) and

(c)that payment for RHC services furnished to patients at the RHC, at the patient's place of residence, or at another facility other than a hospital or CAH, be made to the RHC. As a result of the provisions in section 1862(a)(14) of the Act, RHCs and FQHCs cannot bill for RHC or FQHC services furnished by their practitioners to hospital or CAH inpatients. 6. Payment for Certain Physician Assistant Services Sections 4511 and 4512 of the BBA removed the restrictions on the types of areas and settings in which the Medicare Part B program pays for the professional services of NPs, CNSs, and PAs. This provision also expanded the professional services benefits for NPs and CNSs by authorizing them to bill the program directly for their services when furnished in any area or setting. However, these BBA provisions maintained the current policy that payment for PA services can be made only to the PA's employer regardless of whether the PA is employed directly or is serving as an independent contractor. Section 4205(d)(3)(B) of the BBA amended section 1842(b)(6)(C) of the Act to provide that payment for PA services may be made directly to a PA under certain circumstances. This provision permits Medicare to directly pay a PA who is the owner of an RHC, as described in section 1861(aa)(2) of the Act, for a continuous period beginning before the date of the enactment of the BBA and ending on the date the Secretary determines the RHC no longer meets the requirements of section 1861(aa)(2) of the Act, for services furnished before January 1, 2003. Section 222 of the BIPA amended section 1842(b)(6)(C) of the Act, which permits PAs who owned RHCs and subsequently lost RHC status to receive direct Medicare payment for their services, effective December 21, 2000. This BIPA provision eliminated the January 1, 2003 sunset date. We propose to revise § 410.150(h)(15) and add § 410.150(b)(20) to allow PAs to receive direct Medicare payment for services provided by the RHC, as long as the RHC continues to meet the requirements of section 1861(aa)(2) of the Act. 7. Screening Mammography In June 2000 we released Program Memorandum A-00-30, which stated that preventive physician and nonphysician services, such as screening mammography, were covered when performed in an RHC/FQHC to the same extent as other RHC/FQHC services. We propose to revise § 405.2448 by removing paragraph (d), which states that screening mammography is not considered a covered FQHC service. 8. Payment for High Cost Drugs RHCs are reimbursed based on an all-inclusive payment methodology, subject to an upper payment limit, which includes the cost of drugs provided incident to a patient visit. We are aware that many RHCs would like to provide services such as outpatient cancer treatments to their patients, and that the patients would benefit from this service by not having to travel greater distances to receive treatment elsewhere. However, because drugs are included in the all-inclusive rate per visit, it may not be financially viable for an RHC to provide treatments that require high cost drugs for their patients. We recognize the dilemma that RHCs may face in deciding whether to provide certain treatments in the RHC that would benefit their patients but may put their financial viability at risk. Therefore, we are soliciting comments on this situation and possible solutions that can be addressed through regulation or program guidance. Any possible solution would need to take into account our legislative authority, which does not generally allow reimbursement to RHCs for drugs, our policy on commingling, and the need for administrative accountability. D. Health and Safety, and Quality 1. Quality Assessment and Performance Improvement Program

(QAPI)Currently, each RHC is required to evaluate its total program annually. The evaluation must include reviewing the utilization of the clinic's services using a representative sample of both active and closed clinical records, as well as reviewing the clinic's health care policies. The purpose of the evaluation is to determine whether the utilization of services was appropriate, the established policies were followed, and if any changes are needed. The clinic's staff considers the findings of the evaluation and takes the necessary corrective action. These requirements focus on the meeting and documentation of the clinic's evaluation of its quality care and do not account for the outcome of these activities. Section 4205(b) of the BBA amended section 1861(aa)(2)(I) of the Act to authorize us to require that an RHC have a quality assessment and performance improvement program (QAPI). Therefore, RHCs are required by statute to have a QAPI program and it is a requirement for certification as an RHC. Upon an initial or subsequent survey, an RHC would be required to develop a plan of correction where a viable QAPI program is not in effect. A QAPI program enables the organization to systematically review its operating systems and processes of care to identify and implement opportunities for improvement. Some RHCs have already incorporated a QAPI program into normal RHC operating activities. For those which are starting to develop an appropriate QAPI program, guidance and examples of QAPI-related activities are available from professional and governmental organizations, including some State offices of rural health. HHS previously has contracted with the National Association of RHCs ( *http://www.narhc.org* ) to develop technical assistance materials which provide guidance for RHCs in complying with QAPI requirements. These and other materials are available through HRSA's Office of Rural Health Policy ( *http://www.ruralhealth.hrsa.gov* ). Information is also available from the Rural Assistance Center ( *http://www.raconline.org* ), the National Rural Health Association ( *http://www.nrharural.org* ), and the Rural Policy Research Center ( *http://www.rupri.org* ). As it develops its QAPI program, an RHC may find additional guidance through the information contained in the Institute of Medicine report, “Quality Through Collaboration: The Future of Rural Health Care”, as well as that contained at the database and Web site sponsored by the agency for Healthcare Research and Quality, the National Quality Measures Clearinghouse ( *http://www.qualitymeasures.ahrq.gov/* ). RHCs are encouraged to take advantage of the resources available. We would deem an RHC that chose to utilize a QAPI model program provided by the Department (or other on-line resources mentioned in this regulation) to have met the QAPI CfC, provided that the model program chosen was one that was in compliance with the substantive provisions of § 491.11. We propose to revise § 491.11 to set forth explicit requirements for a QAPI program. An RHC would set its own priorities for performance improvement based on the prevalence and severity of identified problems. The QAPI program would contain three standards that would address:

(1)Program components;

(2)program activities; and

(3)program responsibilities. The first standard, § 491.11(a), would require that an RHC use objective measures to evaluate organizational processes, functions and services and the use of clinic services, including at least the number of patients served and the volume of services. The second standard, § 491.11(b), would require RHCs to adopt or develop performance measures that reflected processes of care and RHC operation and were shown to be predictive of desired patient outcomes or were the outcomes themselves. The RHC would have to use the measures to analyze and track its performance. The RHC would set priorities for performance improvement, considering high-volume, high-risk services, the care of acute and chronic conditions, patient safety, coordination of care, convenience and timeliness of available services or grievances and complaints. Also, the RHC would have to conduct distinct improvement projects and maintain records on its QAPI program for each of the areas listed under the standard in § 491.11(a). Additionally, a project to develop and implement an information technology

(IT)system explicitly designed to improve patient safety and quality of care would be considered as meeting the requirement for a QAPI project under this section. We are proposing this IT provision because we believe that it is critically important that RHCs identify opportunities to improve and expand the use of information technology to prevent medical errors and improve quality of care. This Administration is committed to working with other public and private stakeholders to develop means for improving and expanding the use of IT (such as computerized patient records). We encourage RHCs, as they assess their organizational processes, functions, and services, to identify opportunities and make use of information technologies. We believe that the effective use of IT systems could prove invaluable to improving the quality and safety of patient care over time. We would allow RHCs to receive QAPI recognition for undertaking programs of investment and development of IT systems that are designed to result in improvements in patient safety and quality of care as an alternative to other performance improvement projects (see § 491.11(b)(4)). In recognition of the time and resources required to implement these IT programs, we would not require associated activities to have a demonstrable benefit in the initial stages, but would expect that the quality improvement goals and the associated achievements would be incorporated in the plans for these programs. The third proposed standard, § 491.11(c), would require that the RHCs professional staff, administrative officials, and governing body (if applicable) ensure that there is an effective QAPI plan that addresses identified priorities. 2. Infection Control While the physical plant and environment standard in § 491.6(a)(3) requires that RHCs and FQHCs keep the premises clean and orderly, there is no current Medicare standard addressing infection control in RHCs and FQHCs. We believe that RHCs and FQHCs should be required to have infection control guidelines and an implementation plan. The value of infection control measures in reducing infectious and communicable diseases long has been recognized, and we realize that a large number of clinics and centers may be implementing some aspects of an infection control program. However, because of the real and potential hazards which infectious and communicable diseases present, we believe that it would be prudent to add a formal standard requiring adherence to infection control guidelines that have been recognized by industry standards and regulatory bodies as being appropriate for facilities such as RHCs and FQHCs. The Association for Professionals in Infection Control and Epidemiology

(APIC)and the Society for Healthcare Epidemiology of America (SHEA), in their October 1999 Consensus Panel Report, stated that infection prevention and control issues are important throughout a continuum of care, including physicians' offices, clinics, ambulatory surgical centers, and in individuals' homes through home health agencies. Likewise, a Centers for Disease Control

(CDC)article, entitled “Health-Care Quality Promotion, through Infection Prevention: Beyond 2000”; Vol. 7, No. 2, March-April 2001, by Julie Louise Gerberding, reported that the urgent need for enhanced infection prevention programs in nonhospital settings has been acknowledged for more than a decade. However, programs designed to effectively address this need have been slow to evolve. One contributing factor offered in the article was a lack of regulatory and accreditation standards to ensure that truly effective program components are in place. We agree with the CDC's findings as well as with the intent of the article, and are proposing that the new infection control standard place accountability on RHCs and FQHCs to prevent and control infectious and communicable diseases, and to take actions that result in improvements to infection control practices. We are proposing to add, under § 491.6, a new paragraph

(d)that would require RHCs and FQHCs to have infection control guidelines and an implementation plan. Model guidelines are available from various professional organizations, and RHCs and FQHCs would have flexibility in determining how best to meet these objectives. For example, RHCs and FQHCs would determine how much staff training in infection control would be necessary, the method of oversight, and the appropriate level of documentation that would be required. However, we do expect that RHC and FQHC staff engaged in direct patient care would follow current accepted standards of infection control practice (for example, wearing gloves when handling blood or blood products, and following hand hygiene guidelines). We believe that if a clinic or center currently complies with the infection control standards of the industry for outpatient health care facilities, then they would most likely meet or exceed this proposed standard. The infection control activities should be an integral part of the RHCs or FQHCs overall QAPI program and the FQHCs quality improvement program as also required by section 330(k)(3)(C) of the PHS Act, and should be addressed in these programs on an ongoing basis. 3. Hours of Operation a. Posting of Hours RHCs and FQHCs have varying hours and days of operation based on staff and anticipated patient load. Beneficiaries in rural areas often travel long distances to obtain services. Therefore, we are proposing to require under § 491.6(e) that an RHC or FQHC must post at or near the entrance to the facility a sign that states the days of the week and hours when RHC or FQHC services are furnished. This information would have to be displayed in a manner so that it can be viewed easily by persons who have vision problems and who are in wheelchairs. b. Use of the RHC Facility Section 491.8(a)(6) states that a RHC must have a physician, NP, PA, CNM, CSW, or CP available to furnish patient care services at all times the RHC operates, and that an NP, PA, or CNM must be available to furnish patient care services at least 50 percent of the time the RHC operates. To provide RHCs with flexibility to allow access patients to enter the RHC for purposes other than patient care while complying with the requirements of § 491.8(a)(6), we are clarifying that RHCs may allow patients to enter the waiting room or other areas not utilized for patient care when the premises are opened solely to address administrative matters, or to allow patients entry into the building to get out of inclement weather. The RHC would not be considered “in operation” as an RHC during these periods. No health care services would be provided until a physician, NP, PA, CNM, CSW, or CP was present to provide such services. RHCs that choose to exercise this flexibility should post the hours they offer administrative services only versus the hours they offer RHC health care services. The signage which would be required by § 491.6(e) should clearly delineate the times the NP, PA, CNM, CSW, CP, or physician was present and the RHC would be in operation and providing health care services. If State law does not allow access to the RHC premises when the RHC is not in operation as an RHC, the facility must adhere to State law. 4. Emergency Services and Training We propose to revise § 491.9(c)(3) to reflect current industry standards and procedures for first responses to common life-threatening injuries and acute illnesses. We would expect that clinical personnel responding to emergencies would assess and stabilize sick or injured persons and administer emergency medical treatment while waiting for emergency transport to arrive or until such time that the patient could receive an advanced level of care. RHCs and FQHCs would continue to be required to provide medical emergency procedures as a first response to common life-threatening injuries and acute illness and to have available the drugs and biologicals commonly used in lifesaving procedures. Even though we are proposing to retain the language in the requirement regarding the availability of drugs and biologicals, we propose to eliminate the prescriptive list of those drugs and biologicals that is currently required. In addition to the drugs and biologicals that currently are required, we propose that a clinic or center also have available commonly used equipment and supplies for emergency first response procedures that are appropriate for its patient population. Since the proposed conditions are outcome-oriented, we do not believe that we need to specify all the equipment and supplies that a facility should have to accommodate the emergency medical needs of a clinic or center's patients. However, we would expect a clinic or center to have the emergency equipment and supplies that are commonly found in a physician's office or a clinic. Appropriate drugs, biologicals, equipment, and supplies that one would expect to find in a clinic providing emergency first response procedures might include those items that are normally found in an emergency medical crash cart. We believe that most, if not all, clinics and centers would already have these types of supplies in order to provide the emergency services required under the current regulations. Although we are not specifically proposing to require defibrillators at this time, studies have shown that the appropriate use of defibrillators can save lives. In particular, automated external defibrillators

(AEDs)have been shown to save lives in a variety of settings. The key to saving a life is getting the defibrillator on the patient as soon as possible. According to the American College of Emergency Physicians article entitled “Automatic External Defibrillators,” June 2003 ( *http://www.acep.org/12891.0.html* ), when a person suffers a sudden cardiac arrest, the chance of survival decreases by 7 to 10 percent for each minute that passes without defibrillation. The potential for saved lives supports the financial investment in an AED. Currently, the cost of an AED is approximately $2,000 to $3,000. We are soliciting comments on whether AEDs should be made a regulatory requirement in the future, since RHCs and FQHCs can be located in remote and frontier areas where advanced emergency care might not be available in time to prevent cardiac complications or death. We also are proposing that staff receive training in the provision of the RHCs or FQHCs emergency procedures. The current requirement does not address this issue. Primary care providers such as physicians, nurse practitioners, physician assistants, nurses, and other allied health personnel often do not frequently receive opportunities to participate in a wide range of emergency care procedures, and, therefore, can benefit from training. At a minimum, we would expect that these professionals are trained in basic life support (BLS). The American Heart Association's (AHA's) guidelines for health care provider courses state that its BLS course teaches the skills of cardiopulmonary resuscitation

(CPR)(including ventilation with a barrier device, a bag-mask device, and oxygen) for victims of all ages, and the use of an AED. The course is designed for health care providers that care for patients in a wide variety of settings, both in and out of a hospital. This basic training may also be augmented by the clinic or center through a variety of means. For example, a facility may elect to provide its own in-service training in emergency procedures or it may choose to use outside resources such as basic trauma life support (BTLS), advanced cardiac life support (ACLS), and pediatric advanced life support

(PALS)courses. We encourage clinics and centers to take advantage of these and other existing resources as they determine training needs of personnel providing care to patients. Additionally, as proposed in § 491.9(c)(3)(iii), a clinic or center would be required to provide training for staff. Because a midlevel practitioner is required to be available to furnish patient care at all times the RHC or FQHC operates, we do not expect the nonprofessional staff to be responsible for providing first response emergency care. However, these individuals would need to be trained in accordance with the facility's policies and procedures related to their roles during the provision of emergency medical services by professional staff. We would expect facilities to determine the best way to train these personnel according to the facilities' individual needs. Facilities may elect to use outside resources such as the AHA's Heartsaver First Aid course, which combines first aid, adult CPR, and AED training, in-service training through the clinic or center's professional staff, or a combination of both. Each facility would be expected to develop its own emergency strategies which are consistent with commonly accepted practice and to document such plans in its written policies. 5. Patient Health Records RHCs and FQHCs are required to maintain a medical record for each patient receiving health care services. To update patient health record requirements to reflect technological advances in how physicians or other health care professionals sign and authenticate their signatures, we are proposing to update the medical records requirement at § 491.10(a)(3) for RHCs and FQHCs to reflect our requirements and guidelines for other participating providers regarding electronic medical records and electronic signatures. We propose at § 491.10(a)(3)(v) that all entries (electronic or manual) in the medical record must be legible, complete, dated, timed, and authenticated promptly in written or electronic form by the person responsible for ordering, providing, or evaluating the service furnished. We are also proposing that any entry in the patient health record must be identified and authenticated promptly by the person making the entry. In addition, we are proposing that all entries in the patient health record must be authenticated within 48 hours unless there is a State law that designates a specific timeframe for the authentication of entries. The identification may include signatures, written initials, or computer entry. If rubber stamp signatures are authorized, the individual whose signature the stamp represents must place in the administrative offices of the RHC or FQHC a signed statement to the effect that he or she is the only individual authorized to use the stamp and may not delegate the stamp to another individual. A list of computer or other codes and written signatures must be readily available and maintained under adequate safeguards. When rubber stamps or electronic authorizations are used for identification, the RHC must have policies and procedures in place to ensure that stamps or authorizations are used only by the individuals whose signature they represent. Inherent in these proposed requirements is the idea that there be a specific action by the author to indicate that entries are verified and accurate. Examples of such authentication of entries include: a computerized system that requires the physician to review the document on-line and indicate that it has been approved by entering a computer code; a system in which the physician signs off against a list of entries that must be verified in the individual record; or a mail system in which transcripts are sent to the physician for review, after which he or she signs and returns a postcard identifying the record and verifying its accuracy. A system of auto-authentication in which a physician or other practitioner authenticates a report before transcription is not consistent with these proposed requirements. There must be a method of determining that the practitioner in fact did authenticate the document after it was transcribed. E. Other Proposed Changes 1. General In addition to the regulatory changes previously described, we propose the following: • Adding the definition of “nurse practitioner (NP)” and “physician assistant (PA)” to § 405.2401(b) and removing the definitions from § 491.2 so that RHC/FQHC-related provider definitions are located in the same regulatory section (with the exception of clinical psychologist, which continues to be defined in § 405.2450.) • Adding the word “certified” to the definition of “nurse-midwife” in § 405.2401(b) and § 405.2414 to conform to statutory language in sections 1861(aa) and (gg)(2) of the Act. • Adding the definition of “clinical social worker”

(CSW)to § 405.2401(b). The definition of “covered RHC services” was extended to include the services of a CSW but the definition of a CSW has not been added to the regulations. • Revising the definition of “Federally qualified health center”

(FQHC)in § 405.2401(b) to conform the regulations to current statutory requirements. • Revising the definition of “rural health clinic” to § 405.2401(b) and removing the definition from § 491.2 so that it conforms with statutory language in section 1861(aa)(2) of the Act. • Revising references to the “Secretary” in § 405.2404 and § 491.2 to incorporate gender-neutral language. • Adding the phrase “CNM, CP, CSW services and supplies” to § 405.2411 and § 405.2415 to conform to statutory changes in section 1861(aa)(1)(B) and section 1861(aa)(2)(J) of the Act. • Making additional revisions to § 491.3 to implement proposed certification procedures, in conjunction with the proposed changes to the designation process previously described. • Revising the heading and introductory text of § 491.4 to make it consistent with the comparable CoP provisions for hospitals and most other providers and to emphasize that the requirements of primary concern are State licensure laws. 2. FQHCs Section 5114 of the DRA makes a technical correction to section 1861(aa)(4)(A) of the Act by striking the phrase “(other than subsection (h))” from that clause. This section of the statute identifies the types of health centers receiving funding under section 330 of the PHS Act that are eligible for Medicare FQHC status. Section 330(h) of the PHS Act, to which the clause refers, addresses Healthcare for the Homeless Health Centers. We are conforming our regulations at § 405.2401 to recognize Healthcare for the Homeless Health Centers as Medicare FQHCs. We also are taking this opportunity to delete obsolete references to sections 329 and 340 of the PHS Act. III. Collection of Information Requirements Under the Paperwork Reduction Act

(PRA)of 1995, we are required to provide 60-day notice in the **Federal Register** and solicit public comment when a collection of information requirement is submitted to the OMB for review and approval. In order to evaluate fairly whether OMB should approve an information collection, section 3506(c)(2)(A) of the PRA requires that we solicit comment on the following issues: • The need for the information collection and its usefulness in carrying out the proper functions of our agency. • The accuracy of our estimate of the information collection burden. • The quality, utility, and clarity of the information to be collected. • Recommendations to minimize the information collection burden on the affected public, including automated collection techniques. Therefore, we are soliciting public comment on each of these issues for the information collection requirements

(ICRs)discussed below. A. ICRs Regarding Location of Clinic (§ 491.5) Proposed § 491.5(b) states that an RHC may be granted an exception to the location requirement specified in § 491.5(a)(1) if the clinic meets the requirements listed in § 491.5(b)(1) through (3). Section 491.5(b)(3) states that an RHC may be granted an exception to the location requirements if it meets the essential provider criteria that are outlined in § 491.5(c). As stated in § 491.5(c), CMS grants essential provider status for a period of 3-years. However, a clinic may reapply for essential provider status if it still needed the exception. An RHC must furnish documentation to demonstrate its compliance with one of the conditions listed in § 491.5(c)(1) through (4). The burden associated with these proposed requirements is the time and effort necessary for an RHC to submit an application to CMS for an exception to the location requirement. As part of the application, the RHC must collect and submit to CMS the necessary information to support its claim that it meets one of the essential provider criteria listed in § 491.5(c)(1) through (4). We estimate that it would take each RHC 10 hours to collect and submit the necessary information to CMS. The total estimated annual burden associated with this requirement is 5000 hours. Section 491.5(e)(7) states that at the conclusion of the 3-year exception period, an RHC may renew its essential provider status. The RHC must submit written assurances to the appropriate CMS regional office that it continues to meet the conditions specified in § 491.5. The burden associated with this proposed requirement would be the time and effort necessary to submit written assurances to the appropriate CMS regional office. We estimate that a total of 500 RHCs would be subject to the requirements contained in § 491.5(e)(7). We estimate that it would take each of the 500 RHCs 1 hour to submit the necessary information to CMS. The estimated annual burden is 500 hours. B. ICRs Regarding Physical Plant and Environment (§ 491.6) Proposed § 491.6(d) states that RHCs and FQHCs must protect their patients and staff members by maintaining and documenting an infection control process. The burden associated with this proposed requirement is the time and effort necessary to establish, maintain, and document the infection control process that meets the requirements listed in § 491.6(d)(1) and (2). While these requirements are subject to the PRA, the associated burden is exempt as stated in 5 CFR 1320.3(b)(2). Establishing, maintaining and documenting an infection control program and processes are usual and customary business practices. In addition, maintenance of a documented infection control program is required as part of quality assessment and performance improvement

(QAPI)program. The total burden associated with QAPI program requirements is discussed later in Section III.E of the collection of information section of this regulation. Section 491.6(e) would require clinics or centers to post signs that are noticeable and can be viewed by those with vision problems and those in wheelchairs. The signs must be located at or near the front of the facility. The purpose of the signs is to advise the public of the hours of operation for the center or clinic. The burden associated with this reporting requirement is the time and effort necessary to create signs and post the signs for the public. While this requirement is subject to the PRA, we believe that the associated burden is exempt as stated in 5 CFR 1320.3(b)(2); posting the signs containing the hours of operation is a usual and customary business practice. C. ICRs Regarding Staffing and Staff Responsibilities (§ 491.8) Proposed § 491.8(d) states that a qualified RHC can request a temporary staffing waiver. If the request is approved, the waiver is in effect for a 1-year period. As stated in § 491.8(d)(1), to request a waiver the RHC must demonstrate that it has been unable, despite reasonable efforts in the previous 90-day period, to hire a certified nurse-midwife, nurse practitioner, or physician assistant to furnish services at least 50 percent of the time the RHC provides clinical services. The burden associated with this proposed requirement is the time and effort necessary for an RHC to demonstrate to CMS it has been unable to meet the RHC staffing requirements. We estimate that 100 RHCs would apply for waivers on an annual basis. We believe that it would take 3 hours for each RHC to draft its waiver request and demonstrate its inability to meet the staffing requirements. We estimate the total annual burden to be 300 hours. Proposed § 491.8(d)(3) states that an RHC may submit a request for an additional waiver of staffing requirements no earlier than 6 months after the expiration of the previous waiver. The burden associated with this proposed requirement is the time and effort necessary to submit an additional waiver request. The burden associated with this requirement is explained in our discussion of proposed § 491.8(d)(1). D. ICRs Regarding Patient Health Records (§ 491.10) Proposed § 491.10 states that an RHC or an FQHC must maintain a record for each patient receiving health care services. The record must include legible entries that are completed, dated, timed, and authenticated promptly in written or electronic form by the person responsible for ordering, providing, or evaluating the service. All entries in the patient health record must be authenticated within 48 hours unless there is a State law that designates a specific timeframe for the authentication of entries. The burden associated with these proposed requirements is the time and effort necessary to maintain a patient record. This burden includes the time necessary to record complete, legible entries and to authenticate the record. While these requirements are subject to the PRA, the associated burden is exempt under 5 CFR 1320.3(b)(2). Maintaining and authenticating patient health records is part of usual and customary business practices. As stated in 5 CFR 1320.3(b)(2), the time, effort, and financial resources necessary to comply with a collection of information that would be incurred by persons in the normal course of their activities is exempt from the PRA. E. ICRs Regarding Quality Assessment and Performance Improvement (§ 491.11) Section 491.11 would require an RHC to develop, implement, evaluate, and maintain an effective, ongoing, data-driven quality assessment and performance improvement

(QAPI)program. As part of the QAPI program, § 491.11(b)(1)(i) requires an RHC to adopt or develop performance measures that reflect processes of care and RHC operations. Section 491.11(b)(1)(ii) further requires that the RHC use the measures to analyze and track its performance. Proposed § 491.11(b)(3) states that an RHC must conduct distinct improvement projects. The number and frequency of the distinct improvement projects must reflect the scope and complexity of the clinic's services and available resources. In addition, § 491.11(b)(5) states that an RHC must maintain records on its QAPI program and quality improvement projects. The burden associated with this proposed requirement would be the time and effort necessary for the RHC to maintain records on its QAPI and quality projects. We estimate that it will take each clinic 1 hour per year to meet this requirement. Since there are an estimated 3,700 facilities, the total burden associated with this requirement would be 3,700 annual hours. The burden associated with this requirement is currently approved under OMB# 0938-0334. The burden associated with all of the proposed requirements in § 491.11 is the time and effort necessary for an RHC to develop, implement, evaluate, and maintain a QAPI program. We estimate that it would take each of the 3,700 facilities 40 hours to comply with the requirements in § 491.11. We estimate a one-time annual burden of 148,000 to develop a QAPI program. Table 1.—Estimated Annual Reporting and Recordkeeping Burden Regulation section(s) OMB control number Respondents Responses Total annual burden (hours) § 491.5(c) 0938-New * 500 500 5,000 § 491.5(e)(7) 0938-New *500 500 500 § 491.8(d) 0938-New 100 100 300 § 491.11 0938-0334 3,700 3,700 ** 148,000 Total 4,300 4,300 153,800 * The same 500 respondents are subject to the requirements in both § 491.5(c) and § 491.5(e)(7). They are only counted once in our burden estimate. ** Estimated one-time annual burden. If you comment on these information collection and recordkeeping requirements, please mail copies directly to the following: Centers for Medicare & Medicaid Services, Office of Strategic Operations and Regulatory Affairs, Regulations Development Group, Attn.: William N. Parham, III (Attn: CMS-1910-P2) Room C4-26-05, 7500 Security Boulevard, Baltimore, MD 21244-1850; and Office of Information and Regulatory Affairs, Office of Management and Budget, Room 10235, New Executive Office Building, Washington, DC 20503, Attn: Carolyn Lovett, CMS Desk Officer, CMS-1910-P2, *Carolyn_Lovett@omb.eop.gov* . Fax

(202)395-6947. IV. Regulatory Impact Analysis A. Overall Impact We have examined the impacts of this rule as required by Executive Order 12866 (September 1993, Regulatory Planning and Review), the Regulatory Flexibility Act

(RFA)(September 19, 1980, Pub. L. 96-354), section 1102(b) of the Act, the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4) (UMRA), Executive Order 13132 on Federalism, and the Congressional Review Act (5 U.S.C. 804(2)). Executive Order 12866 (as amended by Executive Order 13258, which merely reassigns responsibility of duties) directs agencies to assess all costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety effects, distributive impacts, and equity). A regulatory impact analysis

(RIA)must be prepared for major rules with economically significant effects ($100 million or more in any one year). The RFA requires agencies to analyze options for regulatory relief of small businesses. For purposes of the RFA, small entities include small businesses, nonprofit organizations, and government jurisdictions. Most hospitals and most other providers and suppliers are small entities, either by nonprofit status or by having revenues of $6 to $29 million or less annually (see 65 FR 69432). For purposes of the RFA, all RHCs and FQHCs are considered to be small entities. Individuals and States are not included in the definition of a small entity. In addition, section 1102(b) of the Act requires us to prepare a regulatory impact analysis if a rule may have a significant impact on the operations of a substantial number of small rural hospitals. This analysis must conform to the provisions of section 603 of the RFA. For purposes of section 1102(b) of the Act, we define a small rural hospital as a hospital that is located outside of a Core-Based Statistical Area and has fewer than 100 beds. We are not preparing an analysis for section 1102(b) of the Act, because we have determined that this proposed rule would not have a significant impact on the operations of a substantial number of small rural hospitals. Section 202 of the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4)

(UMRA)requires that agencies assess anticipated costs and benefits before issuing any rule that may result in an expenditure in any one year of $120 million in the aggregate by State, local, or tribal government, or by the private sector. This proposed rule would not mandate any new requirements for State, local or tribal governments, and private sector costs are expected to be less than the $120 million threshold. Executive Order 13132 establishes certain requirements that an agency must meet when it promulgates a proposed rule (and subsequent final rule) that imposes substantial direct compliance costs on State and local governments, preempts State law, or otherwise has Federalism implications. The proposed rule would not have a substantial effect on State and local governments. Although we view the anticipated results of these regulations as beneficial to the Medicare and Medicaid programs as well as to Medicare beneficiaries and Medicaid recipients, and State governments, we recognize that some of the provisions could be controversial and may be responded to unfavorably by some affected entities. We also recognize that not all of the potential effects of these provisions can be anticipated definitely, especially in view of the interaction with other Federal, State, and local activities regarding outpatient services. In particular, considering the effects of our simultaneous efforts to improve the delivery of outpatient services, it is impossible to meaningfully quantify a projection of the future effect of all of these provisions on RHCs' and FQHCs' operating costs or on the frequency of substantial noncompliance and termination procedures. We believe that this regulation would not have a significant financial impact on a substantial number of small entities, such as RHCs and FQHCs. This analysis, in combination with the rest of the preamble, is consistent with the standards for analysis set forth by the RFA. B. Anticipated Effects 1. Effects of the Location Requirements on Rural Health Clinics There are approximately 3,705 participating RHCs. Of these, approximately 500 no longer meet the location requirements for either because they are not in an area designated by the U.S. Census Bureau as nonurban, or they are not designated by the Health Resources and Services Administration as an eligible shortage area. Participating RHCs that no longer are located in rural, underserved areas could lose RHC status and related cost-based reimbursement, potentially causing them to reduce services or discontinue serving Medicare beneficiaries. The estimated Medicare savings associated with the decertification of certain RHCs from the Medicare program are not considered significant. To minimize the impact of this provision on rural health care, however, the Congress has authorized us to grant, if needed, an exception to clinics determined to be essential to the delivery of primary care in these affected areas. Section 491.5 proposes criteria to determine if an RHC qualifies for an exception to the location requirements. An RHC that is no longer in a valid shortage or is in an urban area may apply for exception from RHC location requirements. Most, but not all, RHCs that apply for an exception are expected to qualify, and would not be decertified based on the location requirements. Section 4205 of the BBA amended section 1833(f) of the Act to require that provider-based RHCs are subject to the same payment methodology as independent RHCs. Before the BBA, payment to provider-based RHCs was made without considering the number of patient visits provided by the RHC and without a limit on the payment per visit. This already has been implemented through manual instructions and has helped to establish payment equity and consistency within the RHC program. We have codified the statutory requirement to pay all RHCs under an all-inclusive rate per visit, which avoids allocation of excessive administration costs to RHCs, and allow exceptions to the per-visit payment limit for qualifying RHCs. We believe the fiscal impact of limiting the provider-based RHC payment to the independent RHC rate per visit has resulted in program savings. Provider-based RHCs that have costs above the all-inclusive cost-per-visit limit required by the law may have experienced some decrease in current reasonable cost basis payments. To reduce detrimental impacts of this decrease, section 4205 of the BBA permits an exception to the upper payment limit for RHCs based in small hospitals of less than 50 beds. The number of beds is determined according to the definitions established in § 412.105(b), or an alternative definition established in a Program Memorandum issued September 30, 1998, and updated on December 6, 2001. The alternative bed definition states that a hospital-based RHC can receive an exception to the per visit payment limit if its hospital has fewer than 50 beds as determined by the hospital's average daily census count, is a sole community hospital located in a level 9-12 UIC, and has an average daily census that does not exceed 40. There are currently 909 provider-based RHCs whose parent hospital has fewer than 50 beds. Of these, 354 are in UICs 9-12 and are therefore eligible for the exception to the per visit payment limit. By changing to the more accurate RUCAs, approximately 100 of these RHCs would no longer be eligible for the exception to the per-visit payment limit, but 251 previously ineligible RHCs would be eligible. This would result in a net total of 505 RHCs eligible for the exception to the per visit payment limit, a gain of 151. We expect that the RHCs that would gain eligibility to the payment limit exception would be in more rural areas that have greater financial challenges. Therefore, the fiscal impact of this change is expected to be minimal. The QAPI requirement may increase burden in the short term because resources currently used for the required evaluation of the clinic's programs would need to be directed to the development of a QAPI program that covers the complexity and scope of the particular clinic. Although the requirements may result in some immediate costs to an individual clinic, we believe that the QAPI program would result in real, but difficult to estimate, long-term economic benefits to the clinic (for example, cost-effective performance practices or higher patient satisfaction that may lead to increased patient visits for the clinic). Further, the QAPI and utilization review requirements replace the current annual evaluation requirement. Resources that the clinics currently are using for the annual evaluation could be devoted to the QAPI program. Therefore, we believe that there would be no long-term increased burden on the clinics. Currently, a number of RHCs, primarily provider-based, have some type of quality improvement program in place. To the extent that a clinic is familiar with collecting data on its operations and measuring quality, the new requirement should not impose significant additional burden. 2. Impact of the QAPI Provisions We estimate that the additional one-time impact for the initial development of the QAPI provisions would be as Shown in Table 2. Table 2 Hours/estimated salary/number of RHCs One-time Cost Annual cost 1 physician/administrator at $58/hr × 3 hrs × 3,300 clinics for medical direction and overview of QAPI program $574,200 1 Mid-level practitioner (physician assistant, nurse practitioner) at $28/hr × 32 hrs × 3,300 clinics for program development 2,956,800 1 clerical staff at $6/hr × 5 hrs × 3,300 clinics 99,000 1 mid-level practitioner at $28/hr × 4 hrs × 3,300 clinics for data collection and analysis. 369,600 1 mid-level practitioner—3 hrs training 277,200 Totals 3,630,000 646,800 To develop our estimates, we used information on the salaries and wage estimation obtained from the American Medical Association. OBRA '89 reduced the nonphysician staffing requirement for RHC qualification from 60 percent to 50 percent. This reduction should have a positive effect on RHCs by providing them more flexibility in satisfying overall staffing needs. 3. Effects on Other Providers We are aware of situations in which an RHC and a physician's private practice occupy the same space and bill Medicare for services either as an RHC or as a physician, depending upon which payment method produces the greater payment. Our revision would require an RHC to be a distinct entity that is not used simultaneously as a private physician office or the private office of any other health care professional. As a result, private physicians or other practitioners who have used this approach under the Medicare program may experience some change in the operation of their practices from an administrative standpoint. 4. Effects on the Medicare and Medicaid Programs As a result of this proposed rule, some existing RHCs would be at risk of losing their RHC status. We believe that any aggregate changes to overall spending would be negligible. This proposed rule would also result in some RHCs losing their exception to the per visit payment limit, while other RHCs would become eligible for the exception to the per visit payment limit. We cannot estimate accurately the payment differential since the clinics vary in terms of size and patient visits. However, we believe that since total expenditures for this program represent a small fraction of the Medicare and Medicaid total budget and less than 20 percent of all RHCs would experience changes to payment rates, any aggregate savings would be insignificant. We also believe an insignificant amount of Medicare and Medicaid program savings would result from the provision that would terminate RHC status for certain providers. An RHC that loses its eligibility to participate in the RHC program likely would choose to participate in the Medicare and Medicaid programs in a non-RHC capacity such as a physician-directed clinic or a group of individual practitioners who would then bill Medicare using the Part B fee-for-service system. C. Alternatives Considered Section 4205 of the BBA imposes new requirements that the RHC program must meet. We considered some of the following alternatives to implement these provisions: 1. “Essential” RHCs Since the statute mandates an exception process for essential clinics, we considered using a national utilization test to recognize clinics that are accepting and treating a disproportionately greater number of Medicare, Medicaid, and uninsured patients in comparison to other participating RHCs, for the purpose of addressing the situation of RHC clusters. For example, using an aggregate threshold based on the average Medicare, Medicaid, and uninsured utilization rates of participating RHCs, an applicant would have to demonstrate that its utilization rates exceed the threshold. Although this test would be administratively feasible, we concluded, based on our analysis of available Medicare and Medicaid RHC data, that it would not determine accurately “essential” clinics at the community level because of the wide variability in the percentage of services furnished to Medicare and Medicaid patients by RHCs. Despite our rejection of a national utilization test, we are open to suggestions on developing a minimum national percentage, which could be integrated with our major community provider test. We also considered the option of establishing less generous tests for identifying RHCs as essential clinics to the delivery of primary care. That is, we considered the establishment of tests narrowly focused on a few extreme cases, such as an exception test for only sole community providers. We rejected this option because of concern that the decertification of a clinic from the RHC program could decrease access to primary care for the entire community. We believe several options should be available to reflect the variability of communities in providing access to care for rural areas. 2. QAPI Program Because the statute mandates that an RHC have a QAPI program, and appropriate procedures for review of utilization of clinic services, no alternatives for the requirement were considered. However, in the preamble of the February 28, 2000, proposed rule, we described alternative ways of satisfying the “minimum level requirement” for the QAPI program and requested public comment. We considered the following alternatives: • Require RHCs to engage in an improvement project in three specified domains annually. • Require a minimum number of improvement projects in any combination of the specified domains annually. • Require a minimum number of projects annually based on patient population. • Rather than requiring a minimum number of projects, require RHCs to demonstrate to the State Survey Agency what projects they are doing and what progress is being achieved. After considering the public comments, which were not conclusive, we decided not to establish a minimum requirement. As we noted in the December 24, 2003, final rule, we did consider alternatives for the rule. One alternative was to take a more rigid approach, whereby the final rule would be more prescriptive in the process that RHCs must follow to develop the QAPI program, to include setting forth specific performance measures to be used, the frequency and number of QAPI “interventions” that must be done, and the type and frequency of data to be collected. While a more rigid approach would increase RHC burden, we realize there would be no assurance that it would result in better or more predictable outcomes. We decided to promote a more flexible and less prescriptive approach to the QAPI condition. We are more concerned with an RHC identifying its own best practices and the outcomes of an RHC's individualized QAPI program than in specific steps the RHC takes to achieve the improvement. A more moderate QAPI requirement would allow an RHC the flexibility to use staff and other resources in ways that more directly support its needs. An RHC can design a program to analyze its own organizational processes, functions, and services, while still being held accountable for results. This decision would allow each RHC the flexibility to fulfill this requirement based on its resources. D. Conclusion We do not expect a significant change in the operations of RHCs or FQHCs generally, nor do we believe a substantial number of small entities in the community, including RHCs, FQHCs, and a substantial number of small rural hospitals, would be affected adversely by these changes. In accordance with the provisions of Executive Order 12866, this regulation was reviewed by the OMB. List of Subjects 42 CFR Part 405 Administrative practice and procedure, Health facilities, Health professions, Kidney diseases, Medical devices, Medicare, Reporting and recordkeeping requirements, Rural areas, X-rays. 42 CFR Part 410 Health facilities, health professions, Kidney diseases, Laboratories, Medicare, Reporting and recordkeeping requirements, Rural areas, X-rays. 42 CFR Part 491 Grant programs—health, Health facilities, Medicaid, Medicare, Reporting and recordkeeping requirements, Rural areas. For the reasons set forth in the preamble, the Centers for Medicare & Medicaid Services proposes to amend 42 CFR chapter IV as set forth below: PART 405—FEDERAL HEALTH INSURANCE FOR THE AGED AND DISABLED Subpart X—Rural Health Clinic and Federally Qualified Health Center Services 1. The authority citation for subpart X continues to read as follows: Authority: Secs. 1102 and 1871 of the Social Security Act (42 U.S.C. 1302 and 1395hh). 2. Section 405.2401(b) is amended by— A. Adding the definitions of “clinical social worker” and “employee” in alphabetical order. B. Republishing the introductory text of the definition of “Federally qualified health center” and revising paragraph

(1)of that definition. C. Adding the word “Certified” before “Nurse-midwife” in the definition of “Nurse-midwife,” changing the “N” of “Nurse-midwife” to lower case, and putting the definition in alphabetical order. D. Removing the definition of “nurse practitioner and physician assistant”. E. Adding the definitions of “nurse practitioner” and “physician assistant” in alphabetical order. F. Revising the definition of “rural health clinic.” The revisions and additions read as follows: § 405.2401 Scope and definitions.

(b)* * * *Clinical social worker (CSW)* means an individual who has the following qualifications:

(1)Possesses a doctoral or master's degree in social work.

(2)After obtaining a doctoral or master's degree in social work, has performed at least 2 years of supervised clinical social work.

(3)Either is licensed or certified as a CSW by the State in which the individual practices or, in the case of an individual in a State that does not provide for licensure or certification, has completed at least 2 years or 3,000 hours of post-master's degree clinical social work practice under the supervision of a qualified master's degree social worker in an appropriate setting such as a hospital, clinic, or SNF.

(4)Is employed by or under contract with the RHC or FQHC to furnish diagnostic and therapeutic mental health services. *Employee* means any individual who, under the common law rules that apply in determining the employer-employee relationship (as applied for purposes of section 3121(d)(2) of the Internal Revenue Code of 1986), is considered to be employed by, or an employee of, an entity. (Application of these common law rules is discussed in 20 CFR 404.1007 and 26 CFR 31.3121(d)-1(c).) *Federally qualified health center (FQHC)* means an entity that has entered into an agreement with CMS to meet Medicare program requirements under § 405.2434 and—

(1)Is receiving a grant under section 330 of the Public Health Service

(PHS)Act, or is receiving funding from such a grant under a contract with a recipient of such a grant and meets the requirements to receive a grant under section 330 of the PHS Act; *Nurse practitioner (NP)* means a registered professional nurse who is currently licensed to practice in the State, who meets the State's requirements governing the qualifications of nurse practitioners, and who meets one of the following conditions:

(1)Is currently certified as a primary care nurse practitioner by the American Nurses' Association or by the National Board of Pediatric Nurse Practitioners and Associates.

(2)Has satisfactorily completed a formal academic 1-year educational program that—

(i)Prepares registered nurses to perform an expanded role in the delivery of primary care;

(ii)Includes at least 4 months (in the aggregate) of classroom instruction and a component of supervised clinical practice; and

(iii)Awards a degree, diploma, or certificate to persons who successfully complete the program.

(3)Has successfully completed a formal educational program (for preparing registered nurses to perform an expanded role in the delivery of primary care) that does not meet the requirements of paragraph

(2)of this definition, and has been performing an expanded role in the delivery of primary care for a total of 12 months during the 18-month period immediately preceding the effective date of this subpart. *Physician assistant* means a person who meets the applicable State requirements governing the qualifications for assistants to primary care physicians, and who meets at least one of the following conditions:

(1)Is currently certified by the National Commission on Certification of Physician Assistants to assist primary care physicians.

(2)Has satisfactorily completed a program for preparing physician assistants that meets all of the following requirements:

(i)Was at least 1 academic year in length.

(ii)Consisted of supervised clinical practice and at least 4 months (in the aggregate) of classroom instruction directed toward preparing students to deliver health care.

(iii)Was accredited by the American Medical Association's Committee on Allied Health Education and Accreditation.

(3)Has satisfactorily completed a formal educational program (for preparing physician assistants) that does not meet the requirements of paragraph

(2)of this definition and assisted primary care physicians for a total of 12 months during the 18-month period that ended on December 31, 1986. *Rural health clinic (RHC)* means an entity that meets the following requirements:

(1)The requirements specified in section 1861(aa)(2) of the Act and part 491 of this chapter concerning RHC services and conditions for approval.

(2)Has filed an agreement with CMS that meets the basic requirements described in § 405.2402 to provide RHC services under Medicare. § 405.2402 [Amended] 3. Amend § 405.2402(d) by removing “he” and adding “the Secretary” in its place. § 405.2404 [Amended] 4. Amend § 405.2404(a)(2)(ii) by removing “he” and adding “the Secretary” in its place. 5. Revise § 405.2410 to read as follows: § 405.2410 Application of Part B deductible and coinsurance.

(a)*Application of deductible* .

(1)Medicare payment for RHC services begins only after the beneficiary has incurred the deductible. Medicare applies the Medicare Part B deductible as follows:

(i)If the deductible is fully met by the beneficiary before the RHC visit, Medicare pays 80 percent of the all-inclusive rate.

(ii)If the deductible is not fully met by the beneficiary before the visit and the amount of the RHC's reasonable customary charge for the service that is applied to the deductible is—

(A)Less than the all-inclusive rate, the amount applied to the deductible is subtracted from the all-inclusive rate and 80 percent of the remainder, if any, is paid to the RHC; or

(B)Equal to or exceeds the all-inclusive rate, no payment is made to the RHC.

(2)Medicare payment for FQHC services is not subject to the usual Part B deductible.

(b)*Application of coinsurance* . The beneficiary is responsible for the coinsurance amount.

(1)For any one service provided by an RHC—

(i)If the deductible has already been met, beneficiary coinsurance liability must not exceed 20 percent of the clinic's reasonable customary charge for the covered service;

(ii)If the deductible has not already been met, the beneficiary coinsurance liability must not exceed 20 percent of any remainder amount after deducting the unmet deductible from the clinic's reasonable customary charge for the covered service.

(2)The beneficiary's deductible and coinsurance liability for any one service furnished by the RHC may not exceed 20 percent of the reasonable amount customarily charged by the RHC for that particular service.

(3)Except for services provided under Medicare Advantage plans to FQHCs in accordance with section 1833(a)(3)(B) of the Act, the coinsurance liability may not exceed 20 percent of the reasonable amount customarily charged by the FQHC for the particular service. 6. Section 405.2411 is amended by— A. Revising paragraph

(a)introductory text. B. Amending paragraphs (a)(1) through (a)(3) by removing the “;” at the end of each paragraph and adding a “.” in its place. C. Amending paragraph (a)(4) by removing the “; and” at the end of the paragraph and adding “.” in its place. D. Adding new paragraphs (a)(6) through (a)(8). E. Revising paragraph (b). F. Adding a new paragraph (c). The revisions and additions read as follows: § 405.2411 Scope of benefits.

(a)Rural health clinic services reimbursable under this part are as follows:

(6)Certified nurse-midwife

(CNM)services.

(7)Clinical psychologists

(CP)and clinical social worker

(CSW)services specified in § 405.2450 of this subpart.

(8)Service and supplies furnished as an incident to CP or CSW services, as specified in § 405.2452 of this subpart.

(b)RHC services are covered when furnished in an RHC setting or other outpatient setting, including a patient's place of residence or a skilled nursing facility.

(c)RHC services are not covered in a hospital, as defined in section 1861(e)(1) of the Act, or a critical access hospital. 7. Section 405.2414 is amended by— A. Revising the section heading. B. Revising paragraph (a)(1). C. Adding the word “certified” before “nurse-midwife” in paragraph (a)(4). D. Adding the word “certified” before “nurse-midwives” in paragraph (c). The revisions read as follows: § 405.2414 Nurse practitioner (NP), physician assistant (PA), and certified nurse-midwife

(CNM)services.

(a)* * *

(1)Furnished by a nurse practitioner, physician assistant or certified nurse-midwife, who is employed by, or receives compensation from, the rural health clinic; 8. Amend § 405.2415 by— A. Revising the section heading. B. Revising the introductory text of paragraph (a). C. Revising paragraph (a)(4). D. Revising paragraph (b). The revisions read as follows: § 405.2415 Services and supplies incident to a clinical psychologist (CP), clinical social worker (CSW), nurse practitioner (NP), physician assistant (PA), or certified nurse mid-wife

(CNM)services.

(a)Services and supplies incident to a clinical psychologist's or clinical social worker's, nurse practitioner's, physician assistant's, or certified nurse-midwife's services are reimbursable under this subpart if the service or supply is—

(4)Furnished under the direct, personal supervision of a nurse practitioner, physician assistant, certified nurse-midwife, clinical psychologist, clinical social worker, or physician; and

(b)The direct personal supervision requirement is met in the case of a nurse practitioner, physician assistant, certified nurse-midwife, nurse practitioner, clinical psychologist, or clinical social worker only if the person is permitted to supervise those services under the written policies governing the RHC. § 405.2448 [Amended] 9. Amend § 405.2448 by removing and reserving paragraph (d). 10. Section 405.2462 is revised to read as follows: § 405.2462 Payment for rural health clinic services and Federally qualified health center services.

(a)*General rules.*

(1)RHCs and FQHCs are paid on the basis of an all-inclusive rate per visit, subject to a payment limit.

(2)The Medicare Administrative Contractor or fiscal intermediary determines the all-inclusive rate in accordance with this subpart and instructions issued by CMS.

(b)*Rules for RHCs.* RHCs must meet the following requirements:

(1)Does not share space, staff, supplies, records, and other resources during RHC hours of operation with a private Medicare or Medicaid approved or certified practice owned, controlled or operated by the same physicians and nonphysician practitioners that staff the RHC as employees or contractors; and

(2)If sharing a multipurpose clinic with other types of health providers or suppliers, appropriately allocates and excludes from the RHC cost report the net non-RHC costs associated with the sharing of common space, medical support staff, or other physical resources.

(3)If an RHC is an integral and subordinate part of a hospital, it can receive an exception to the per visit payment limit if the hospital has fewer than 50 beds as determined by using one of the following methods:

(i)The determination of the number of beds at § 412.105(b) of this chapter.

(ii)The hospital's average daily patient census count of those beds described in § 412.105(b) of this chapter and the hospital meets all of the following conditions:

(A)It is a sole community hospital as determined in accordance with § 412.92 or essential access community hospital as determined in accordance with § 412.109(a) of this chapter.

(B)It is located in a level 9 or 10 Rural-Urban Commuting Area (RUCA).

(C)It has an average daily patient census that does not exceed 40.

(c)*Payment procedures.* To receive payment, an RHC or FQHC must follow the payment procedures specified in § 410.165(a) of this chapter.

(d)*Mental health limitation.* Payment for the outpatient treatment of mental, psychoneurotic, or personality disorders is subject to the limitations on payment in § 410.155 of this chapter. 11. In § 405.2466 paragraph (b)(1)(iii) is revised to read as follows: § 405.2466 Annual reconciliation.

(b)* * *

(1)* * *

(iii)Medicare payment to the RHC or FQHC is equal to its reasonable costs less aggregate coinsurance and deductible amounts billable, but in no case may total Medicare payment exceed 80 percent of reasonable costs. § 405.2468 [Amended] 12. In § 405.2468 paragraph (b)(1) is revised by removing the parenthetical statement “(RHCs are not paid for services furnished by contracted individuals other than physicians.)” PART 410—SUPPLEMENTARY MEDICAL INSURANCE

(SMI)BENEFITS 13. The authority citation for part 410 continues to read as follows: Authority: Secs. 1102, 1834, 1871, and 1893 of the Social Security Act (42 U.S.C. 1302, 1395m, 1395hh, and 1395ddd). 14. Section 410.150 is amended by— A. Revising the first sentence of paragraph (b)(15). B. Adding a new paragraph (b)(20). The revision and addition read as follows: § 410.150 To whom payment is made.

(b)* * *

(15)Except for certain physician assistant services provided in a rural health clinic owned by a physician assistant, as specified in paragraph (b)(20) of this section, to the qualified employer of a physician assistant for professional services furnished by the physician assistant and for services and supplies furnished incident to his or her services. * * *

(20)To a physician assistant who was the owner of a rural health clinic as described § 405.2401(b) of this subchapter. Payment is made to such physician assistant for services and supplies furnished incident to his or her services only if—

(i)No facility, other provider charges, or other amount has been paid for services furnished by such physician assistant; and

(ii)The physician assistant owned the rural health clinic for a continuous period beginning on or before August 4, 1997 and ending on the date that the Secretary determines that the clinic no longer meets the requirements of section 1861(aa)(2) of the Act. PART 491—CERTIFICATION OF CERTAIN HEALTH FACILITIES 15. The authority citation for part 491 continues to read as follows: Authority: Sec. 1102 of the Social Security Act (42 U.S.C. 1302); and sec. 353 of the Public Health Service Act (42 U.S.C. 263a). 16. Section 491.2 is revised to read as follows: § 491.2 Definitions. As used in this subpart, unless the context indicates otherwise: *Certified nurse-midwife (CNM), clinical social worker (CSW), nurse practitioner (NP), physician, and physician assistant (PA)* mean an individual who has the qualifications for such practitioner set forth in § 405.2401 of this chapter. *Clinical psychologist (CP)* means an individual who has qualifications as defined in § 405.2450 of this chapter. *Nonurban area* means an area that is not delineated as an urbanized area by the U.S. Census Bureau. *Rural area* means an area that is not delineated as an urbanized area by the U.S. Census Bureau. *Rural health clinic* means a facility as defined in § 405.2401(b). *Shortage area* means a geographic area that meets one of the following criteria:

(1)Designated by the Secretary as a geographic primary care health professional shortage area under section 332(a)(1)(A) of the Public Health Service Act (PHS Act);

(2)Designated by the Secretary as a population group primary care HPSA under section 332(a)(1)(B) of the PHS Act;

(3)Designated by the Secretary as a medically underserved area (but not as a medically underserved population group) under section 330(b)(3) of the PHS Act; or

(4)Designated by the chief executive officer of the State and certified by the Secretary as an area with a shortage of personal health services under section 6213(c) of the Omnibus Budget Reconciliation Act of 1989. 17. Section 491.3 is revised to read as follows: § 491.3 General certification requirements.

(a)*General.*

(1)RHCs participate in Medicare in accordance with an agreement as specified in § 405.2402 through § 405.2404 of this chapter.

(2)If CMS approves or disapproves the participation request of a prospective RHC, CMS notifies the appropriate State agency.

(3)CMS deems an entity that is approved for Medicare participation as an RHC to meet the standards for certification under Medicaid.

(b)*Permanent and mobile units.* An RHC and an FQHC may be located in a permanent or a mobile unit.

(1)*Permanent unit.* The objects, equipment, and supplies necessary for the provision of services furnished directly by the clinic or center are housed in a permanent structure.

(2)*Mobile unit.* The objects, equipment, and supplies necessary for the provision of services furnished directly by the clinic or center are housed in a mobile structure, which has fixed, scheduled locations.

(3)*Permanent unit in more than one location.* If the RHC or FQHC services are furnished at permanent units in more than one location, each unit is independently considered for certification as an RHC or FQHC and must meet the location requirements based on the physical location of the clinic or center. 18. Section 491.4 is revised to read as follows: § 491.4 Compliance with State licensure laws. The RHC or FQHC and its staff meet applicable Federal laws related to the health and safety of patients as well as State licensure requirements. 19. Section 491.5 is amended by revising paragraphs

(a)through

(e)to read as follows: § 491.5 Location of clinic.

(a)*General location requirements.*

(1)An existing RHC or an applicant requesting entrance into the Medicare program as an RHC—

(i)Is located in a rural area that is currently designated as a shortage area as defined in § 491.2; and

(ii)The designation of such shortage area has been made or updated during the past 3 years.

(2)An FQHC is located in a rural or urban area that is designated as either a medically underserved area or includes a medically underserved population group.

(b)*Location exception requirements.* An RHC may be considered for an exception to the location requirements specified in § 491.5(a)(1) if the clinic— (1)(i) Is in an area currently classified by the U.S. Census Bureau as an urbanized area; or

(ii)Is in an area not currently designated as a shortage area. (2)(i) Is located in an area that has been classified as an Urbanized Area by the U.S. Census Bureau and is in a level 4 or higher RUCA; and

(ii)Demonstrates that at least 51 percent of the clinic's patients reside in an adjacent nonurbanized area.

(3)Meets the essential provider criteria specified in paragraph

(c)of this section.

(c)*Essential provider criteria.* CMS grants essential provider status is for a period of 3 years. At the end of the 3-year period, the clinic may reapply for continued essential provider status if an exception is still needed. To receive an exception to the location requirements, an RHC must provide documentation to support that it meets one of the following conditions:

(1)*Sole community provider.* The RHC is the only participating primary care provider that meets either of the following criteria:

(i)Is at least 25 miles from the nearest participating primary care provider.

(ii)Is at least 15 miles but less than 25 miles from the nearest participating primary care provider and demonstrates that it is more than 30 minutes from the nearest primary care provider based on local topography, predictable weather conditions, or posted speed limits. For purposes of this exception, a participating primary care provider means another RHC, FQHC, or other primary care provider that actively is accepting and treating Medicare, Medicaid, low-income and uninsured patients (regardless of their ability to pay).

(2)*Major community provider.* The RHC must meet the following conditions to be considered a major community provider:

(i)Has a Medicare, Medicaid, low-income and uninsured patient utilization rate greater than or equal to 51 percent or a low-income patient utilization rate greater than or equal to 31 percent.

(ii)Is actively accepting and treating a major share of the Medicare, Medicaid, low-income, and uninsured patients (regardless of their ability to pay) compared to other participating primary care providers that are within 25 miles of the RHC.

(3)*Specialty clinic: Obstetrics/gynecology (ob/gyn) or pediatrics.* The RHC must meet all the following conditions to be considered a specialty clinic:

(i)Exclusively provides ob/gyn or pediatric health services.

(ii)Is the sole provider or major source of ob/gyn or pediatrics health services for Medicare (when applicable), Medicaid, low-income, and uninsured patients (regardless of their ability to pay) and that meets either of the following conditions:

(A)Is at least 25 miles from the nearest participating primary care provider of ob/gyn or pediatric services; or

(B)Is at least 15 miles but less than 25 miles from the nearest participating primary care provider of ob/gyn or pediatric services and can demonstrate that it is more than 30 minutes from the nearest primary care provider providing these services based on local topography, predictable weather conditions, or posted speed limits.

(iii)Is actively accepting and treating Medicare (where applicable), Medicaid, low-income, and uninsured patients;

(iv)Has a Medicare, Medicaid, low-income patient and uninsured patient utilization rate greater than or equal to 31 percent.

(v)Provides ob/gyn or pediatric health services onsite to clinic patients.

(4)*Extremely rural community provider* . The RHC must meet the following conditions to be considered an extremely rural community provider:

(i)Is actively accepting and treating Medicare, Medicaid, low-income, and uninsured patients (regardless of their ability to pay).

(ii)Is located in a frontier county (6 or less persons per square mile) or in a Rural-Urban Commuting Area level 10 area.

(d)*Termination* .

(1)CMS decertifies a clinic from participation in the Medicare program as an RHC, effective 180 days after the date that the RHC no longer meets the location requirements, unless—

(i)An application to update the shortage area designation has been received by the Health Resources and Services Administration

(HRSA)not later than 3 years from the date of the last designation; or

(ii)The RHC has submitted an application for an exception to the location requirement as specified in paragraph

(e)of this section and meets the exception standards set forth in paragraphs

(b)and

(c)of this section.

(2)CMS may terminate RHC status at any time if it determines that the RHC is not in compliance with any certification requirements.

(e)*Process for essential provider status* .

(1)If HRSA has not received an application to update a designation by the end of the 3 years from the date of the previous designation, an RHC in such area has 90 days from the end of the 3-year period to submit its request to CMS for an exception in order to continue to be considered to be an essential provider.

(2)If HRSA has proposed for withdrawal or withdrawn a designation, the RHC in such area must submit its request to CMS for an exception in order to continue to be considered an essential provider 90 days from the date the designation was proposed for withdrawal or withdrawn.

(3)If HRSA has disapproved an application to update a designation, the RHC in such area has 90 days from the date of the disapproval to submit a request for a location exception in order to be considered an essential provider.

(4)An existing RHC may apply for an exception from decertification by submitting to the appropriate CMS regional office a written request with any necessary documentation demonstrating that it meets one of the essential provider criteria specified in paragraph

(c)of this section.

(5)CMS does not decertify an RHC that has submitted an application for an exception within 90 days from the date that the RHC no longer meets the location requirements while the application for an exception is under review, for a period not to exceed 180 days from the date the RHC no longer meets the location requirement, or the effective date of the final rule, whichever is later. In rare circumstances, the CMS RO may request an extension from the CMS Central Office if it has not been possible to process the location exception request before the RHC would be decertified.

(6)The CMS regional office may grant a 3-year exception based on its review of an RHC request and other relevant information, if such CMS regional office determines that the RHC is essential to the delivery of primary care services that otherwise are not available in the geographic area served by the RHC, as specified in paragraph

(b)of this section.

(7)At the end of the 3-year exception period, a clinic may renew its essential provider status by submitting written assurances to the appropriate CMS regional office that it continues to meet the conditions specified in this section.

(8)An RHC that is located in an area for which an application to update the designation has not been submitted to HRSA or has been found by HRSA to not qualify for an eligible designation, and has not submitted an application for an exception within 90 days of the date that the designation is more than 3 years old, may continue to operate as an RHC for 180 calendar days after the expiration of the applicable 3-year period, effective the last day of the month.

(9)A provider-based RHC that does not meet the location requirements and does not qualify for an exception and has submitted an application to CMS to be another type of Medicare provider that requires a State survey for certification, may receive an additional 120 days extension of their status as an RHC while their application is being processed. 20. Section 491.6 is amended by— A. Adding paragraph (d). B. Adding paragraph (e). The additions read as follows: § 491.6 Physical plant and environment.

(d)*Infection control* . The RHC or FQHC must protect patients and staff by maintaining and documenting an infection control process that—

(1)Follows accepted standards of practice, including the use of standard precautions, to prevent the transmission of infectious and communicable diseases; and

(2)Is an integral part of the quality assessment and performance improvement

(QAPI)programs.

(e)*Hours of operation* . The clinic or center must post signs that are noticeable and can be viewed by those with vision problems and those in wheelchairs at or near the entrance to the facility to advise the public of the days of the week and hours when services are furnished. 21. Section 491.8 is amended by— A. Revising paragraphs (a)(1), (a)(3), and (a)(6). B. Adding paragraph (d). The revisions and additions read as follows: § 491.8 Staffing and staff responsibilities.

(a)* * *

(i)RHC or FQHC has a health care staff that includes one or more physicians.

(ii)A RHC must employ one or more physician assistants or nurse practitioners.

(3)The physician assistant, nurse practitioner, certified nurse-midwife, clinical social worker, or clinical psychologist member of the staff may be the owner or an employee of the clinic or center, or may furnish services under contract to the clinic or center.

(6)A physician, nurse practitioner, physician assistant, certified nurse-midwife, clinical social worker, or clinical psychologist is available to furnish patient care services at all times the clinic or center operates. In addition, for RHCs, a nurse practitioner, physician assistant, or certified nurse-midwife is available to furnish patient care services at least 50 percent of the time the RHC operates.

(d)*Temporary staffing waiver* .

(1)CMS may grant a temporary waiver of the RHC staffing requirements in paragraphs (a)(1)(ii) and (a)(6) of this section for a 1-year period to a qualified RHC, if the RHC requests a waiver and demonstrates that it has been unable, despite reasonable efforts in the previous 90-day period, to hire a certified nurse-midwife, nurse practitioner, or physician assistant to furnish services at least 50 percent of the time the RHC provides clinical services, or to hire a PA or NP as a direct employee.

(2)CMS terminates the RHC from participation in the Medicare program, if the RHC is not in compliance with the provisions waived under paragraphs (a)(1) and (a)(6) of this section at the expiration of the waiver.

(3)The RHC may submit its request for an additional waiver of staffing requirements under this paragraph no earlier than 6 months after the expiration of the previous waiver. 22. Section 491.9 is amended by— A. Revising paragraph (c)(2). B. Revising paragraph (c)(3). The revisions and addition read as follows: § 491.9 Provision of services.

(c)* * *

(2)*Laboratory* . These requirements apply to RHCs but not to FQHCs. The clinic provides laboratory services in accordance with part 493 of this chapter, which implements the provisions of section 353 of the Public Health Service Act. The clinic provides basic laboratory services essential to the immediate diagnosis and treatment of the patient. See § 405.2462 of this chapter for payment requirements for clinical laboratory services furnished within the RHC setting. These laboratory services include the following:

(i)Chemical examinations of urine by stick or tablet method or both (including urine ketones).

(ii)Hemoglobin or hematocrit.

(iii)Blood glucose.

(iv)Examination of stool specimens for occult blood.

(v)Pregnancy tests.

(vi)Primary culturing for transmittal to a certified laboratory.

(3)*Emergency* . The clinic or center must—

(i)Provide medical emergency procedures as a first response to common life-threatening injuries and acute illnesses;

(ii)Have available the drugs, biologicals, equipment, and supplies, which are appropriate for the facility's patient population and which are commonly used in emergency first response procedures; and

(iii)Provide training for staff in the provision of these emergency procedures according to the clinic's or center's policies that are consistent with commonly accepted practice as well as in accordance with applicable Federal, State, and local laws. 23. Section 491.10 is amended by— A. Revising paragraph (a)(3) introductory text. B. Removing the “;” at the end of paragraphs (a)(3)(i) through (a)(3)(iv) and adding a “.” in its place. C. Adding a new paragraph (a)(3)(v). The revision and addition read as follows: § 491.10 Patient health records.

(a)* * *

(3)For each patient receiving RHC or FQHC services at such facility, the RHC or FQHC maintains a record that includes the following, as applicable:

(v)Legible entries that are completed, dated, timed, and authenticated promptly in written or electronic form by the person responsible for ordering, providing, or evaluating the service. Any entry in the patient health record must be identified and authenticated promptly by the person making the entry. All entries in the patient health record must be authenticated within 48 hours unless there is a State law that designates a specific timeframe for the authentication of entries. 24. Revise § 491.11 to read as follows: § 491.11 Quality assessment and performance improvement for RHCs. The RHC must develop, implement, evaluate, and maintain an effective, ongoing, data-driven quality assessment and performance improvement

(QAPI)program. The self-assessment and performance improvement program must be appropriate for the complexity of the RHCs organization and services and focus on maximizing outcomes by improving patient safety, quality of care, and patient satisfaction.

(a)*Standard: Components of a QAPI program* . The RHC's QAPI program must include, but not be limited to, the use of objective measures to evaluate the following:

(1)Organizational processes, functions, and services.

(2)Utilization of clinic services, including at least the number of patients served and the volume of services.

(b)*Standard: Program activities* .

(1)For each of the areas listed in paragraph (a)(1) of this section, the RHC must do the following:

(i)Adopt or develop performance measures that reflect processes of care and RHC operation and are shown to be predictive of desired patient outcomes or to be the outcomes themselves.

(ii)Use the measures to analyze and track its performance.

(2)The RHC must set priorities for performance improvement, considering either high-volume, high-risk services, the care of acute and chronic conditions, patient safety, coordination of care, convenience and timeliness of available services, or grievances and complaints.

(3)The RHC must conduct distinct improvement projects. The number and frequency of distinct improvement projects conducted by the RHC must reflect the scope and complexity of the clinic's services and available resources.

(4)An RHC that develops and implements an information technology system explicitly designed to improve patient safety and quality of care meets the requirement for a project under this section.

(5)The RHC must maintain records on its QAPI program and quality improvement projects.

(c)*Standard: Program responsibilities* . The RHC's professional staff, administrative officials, and governing body (if applicable) are responsible for the following:

(1)Identifying or approving QAPI priorities.

(2)Ensuring that QAPI activities that are developed to address identified priorities are implemented and evaluated. (Catalog of Federal Domestic Assistance Program No. 93.773, Medicare—Hospital Insurance; and Program No. 93.774, Medicare—Supplementary Medical Insurance Program) Dated: October 11, 2007. Kerry Weems, Acting Administrator, Centers for Medicare & Medicaid Services. Approved: February 28, 2008. Michael O. Leavitt, Secretary. Editorial Note: This document was received at the Office of the Federal Register on June 9, 2008. [FR Doc. E8-13280 Filed 6-26-08; 8:45 am] BILLING CODE 4120-01-P 73 125 Friday, June 27, 2008 Proposed Rules Part IV Department of Justice Drug Enforcement Administration 21 CFR Parts 1300, 1304, et al. Electronic Prescriptions for Controlled Substances; Proposed Rule DEPARTMENT OF JUSTICE Drug Enforcement Administration 21 CFR Parts 1300, 1304, 1306, and 1311 [Docket No. DEA-218P] RIN 1117-AA61 Electronic Prescriptions for Controlled Substances AGENCY: Drug Enforcement Administration (DEA), Department of Justice. ACTION: Notice of Proposed Rulemaking. SUMMARY: DEA is proposing to revise its regulations to provide practitioners with the option of writing prescriptions for controlled substances electronically. These regulations would also permit pharmacies to receive, dispense, and archive these electronic prescriptions. These proposed regulations would be an addition to, not a replacement of, the existing rules. These regulations provide pharmacies, hospitals, and practitioners with the ability to use modern technology for controlled substance prescriptions while maintaining the closed system of controls on controlled substances dispensing; additionally, the proposed regulations would reduce paperwork for DEA registrants who dispense or prescribe controlled substances and have the potential to reduce prescription forgery. The proposed regulations would also have the potential to reduce the number of prescription errors caused by illegible handwriting and misunderstood oral prescriptions. Moreover, they would help both pharmacies and hospitals to integrate prescription records into other medical records more directly, which would increase efficiency, and would reduce the amount of time patients spend waiting to have their prescriptions filled. DATES: Written comments must be postmarked, and electronic comments must be sent, on or before September 25, 2008. ADDRESSES: To ensure proper handling of comments, please reference “Docket No. DEA-218” on all written and electronic correspondence. Written comments sent via regular or express mail should be sent to Drug Enforcement Administration, Attention: DEA Federal Register Representative/ODL, 8701 Morrissette Drive, Springfield, VA 22152. Comments may be directly sent to DEA electronically by sending an electronic message to *dea.diversion.policy@usdoj.gov* . Comments may also be sent electronically through *http://www.regulations.gov* using the electronic comment form provided on that site. An electronic copy of this document is also available at the *http://www.regulations.gov* Web site. DEA will accept electronic comments containing MS word, WordPerfect, Adobe PDF, or Excel files only. DEA will not accept any file formats other than those specifically listed here. FOR FURTHER INFORMATION CONTACT: Mark W. Caverly, Chief, Liaison and Policy Section, Office of Diversion Control, Drug Enforcement Administration, 8701 Morrissette Drive, Springfield, VA 22152, Telephone

(202)307-7297. SUPPLEMENTARY INFORMATION: *Posting of Public Comments:* Please note that all comments received are considered part of the public record and made available for public inspection online at *http://www.regulations.gov* and in the Drug Enforcement Administration's public docket. Such information includes personal identifying information (such as your name, address, etc.) voluntarily submitted by the commenter. If you want to submit personal identifying information (such as your name, address, etc.) as part of your comment, but do not want it to be posted online or made available in the public docket, you must include the phrase “PERSONAL IDENTIFYING INFORMATION” in the first paragraph of your comment. You must also place all the personal identifying information you do not want posted online or made available in the public docket in the first paragraph of your comment and identify what information you want redacted. If you want to submit confidential business information as part of your comment, but do not want it to be posted online or made available in the public docket, you must include the phrase “CONFIDENTIAL BUSINESS INFORMATION” in the first paragraph of your comment. You must also prominently identify confidential business information to be redacted within the comment. If a comment has so much confidential business information that it cannot be effectively redacted, all or part of that comment may not be posted online or made available in the public docket. Personal identifying information and confidential business information identified and located as set forth above will be redacted and the comment, in redacted form, will be posted online and placed in the Drug Enforcement Administration's public docket file. Please note that the Freedom of Information Act applies to all comments received. If you wish to inspect the agency's public docket file in person by appointment, please see the FOR FURTHER INFORMATION CONTACT paragraph. I. Background Legal Authority DEA implements the Comprehensive Drug Abuse Prevention and Control Act of 1970, often referred to as the Controlled Substances Act

(CSA)and the Controlled Substances Import and Export Act (21 U.S.C. 801-971), as amended. DEA publishes the implementing regulations for these statutes in Title 21 of the Code of Federal Regulations (CFR), Parts 1300 to 1399. These regulations are designed to ensure an adequate supply of controlled substances for legitimate medical, scientific, research, and industrial purposes, and to deter the diversion of controlled substances to illegal purposes. The CSA mandates that DEA establish a closed system of control for manufacturing, distributing, and dispensing controlled substances. Any person who manufactures, distributes, dispenses, imports, exports, or conducts research or chemical analysis with controlled substances must register with DEA (unless exempt) and comply with the applicable requirements for the activity. Controlled Substances Controlled substances are drugs that have a potential for abuse and psychological and physical dependence; these include opiates, stimulants, depressants, hallucinogens, anabolic steroids, and drugs that are immediate precursors of these classes of substances. DEA lists controlled substances in 21 CFR part 1308. The substances are divided into five schedules: Schedule I substances have a high potential for abuse and have no accepted medical use in treatment in the United States. These substances may only be used for research, chemical analysis, or manufacture of other drugs. Schedule II-V substances have accepted medical uses and also have potential for abuse and psychological and physical dependence. Virtually all Schedule II-V controlled substances are available only under a prescription written by a practitioner licensed by the State and registered with DEA to dispense the substances. Overall, controlled substances constitute between 10 percent and 11 percent of all prescriptions written in the United States. History The CSA and DEA's regulations were originally adopted at a time when most transactions and particularly prescriptions were done on paper. The CSA mandates that some records must be created and kept on forms that DEA provides and that many controlled substance prescriptions must be manually signed. In 1999, in response to requests from the regulated community, DEA began to examine how to revise its regulations to allow the use of electronic systems within the limits imposed by the statute and mindful that the records had to be usable in legal actions. On April 1, 2005, after extensive consultation with the regulated community, DEA published a final rule that allowed the electronic creation, signature, transmission, and retention of records of orders for Schedule I and II controlled substances, orders that prior to that time had to be created on preprinted forms that DEA issued (70 FR 16901, April 1, 2005). At the same time, DEA began to examine how to revise its rules to allow electronic prescriptions for controlled substances. In addition to complying with the mandates of the CSA, regulations on electronic prescriptions must be consistent with other statutory mandates and Federal regulations. The Electronic Signatures in Global and National Commerce Act of 2000, commonly known as E-Sign, was signed into law on June 30, 2000 (Pub. L. 106-229). It establishes the basic rules for using electronic signatures and records in commerce. E-Sign was enacted to encourage electronic commerce by giving legal effect to electronic signatures and records and to protect consumers. E-Sign provides that, with respect to any transaction in or affecting interstate or foreign commerce, a signature may not be denied legal effect solely because it is in electronic form (15 U.S.C. 7001(a)). However, E-Sign further provides that, where a statute or regulation requires retention of a record, and an electronic record is used to meet such requirement, Federal, State, and local agencies may set performance standards to ensure accuracy, record integrity, and accessibility of records (15 U.S.C. 7004(b)(3)(A)). Such performance standards may be specified in a manner that requires the implementation of a specific technology if such requirement serves an important governmental objective and is substantially related to that objective interest (Id.). In 2003, Congress enacted the Medicare Prescription Drug, Improvement, and Modernization Act

(MMA)(Pub. L. 108-173). Section 1860D-4(e) (codified at 42 U.S.C. 1395w-104(e)) contains the requirement that the electronic transmission of prescriptions and prescription-related information for covered Part D drugs prescribed for Part D eligible individuals comply with final uniform standards adopted by the Secretary of the Department of Health and Human Services (HHS). One of the considerations in support of this move to electronic prescriptions was the view that using electronic prescriptions in lieu of written or oral prescriptions could reduce medical errors that occur because handwriting is illegible or phoned in prescriptions are misunderstood as a result of similar sounding medication names. Another consideration is that, if prescription records are linked to other medical records, practitioners can be alerted at the time of prescribing to possible interactions with other drugs the patient is taking or allergies a patient might have. Electronic prescribing systems also can link to insurance formulary lists to inform the practitioner prior to prescribing whether a drug is covered by a patient's insurance. HHS adopted a rule on the transmission standard for electronic prescriptions in November 2005 (70 FR 67593, November 7, 2005) and revised it on June 23, 2006 (71 FR 36023). The standard focuses on the format for the transmitted information, not with the process of creating the prescription or maintaining the record at the pharmacy. HHS adopted the National Council of Prescription Drug Programs (NCPDP) SCRIPT Standard, Implementation Guide, Version 8.1. The standard specifies fields (name, date, address, etc.) and field lengths for certain transactions including issuing new prescriptions and refills. The rule applies to prescriptions issued to patients under Part D (the prescription drug program for Medicare patients). The rule does not require practitioners or pharmacies to use electronic prescriptions, but rather requires that companies that sponsor Part D coverage establish and maintain an electronic prescription program that meets the standard. The purpose of the standard is to ensure that electronic prescriptions are created and transmitted in a format that can be read by the receiving pharmacy (i.e., that the systems creating, transmitting, and receiving the prescriptions are interoperable). The rule DEA is hereby proposing has been written to be consistent with the foregoing HHS standard. However, it bears emphasis that the context in which the HHS standard was issued was not specific to controlled substances and therefore not designed to provide safeguards against the diversion of controlled substances. The responsibility for establishing regulatory safeguards against diversion of controlled substances falls upon DEA as the agency charged with administering and enforcing the CSA. Accordingly, while the rule being proposed here by DEA is designed to work in tandem with the HHS standard, its scope is necessarily distinct from the HHS standard. Prescription records and transmission are also subject to the Health Insurance Portability and Accountability Act (HIPAA), which establishes protection for health information. Any party to the creation, transmission, and storage of prescriptions must meet standards to ensure that the information is protected and not revealed to persons who are not authorized to see it. Health Plans, Health Care Clearinghouses, and covered Health Care Providers that are involved in the transmission of prescriptions must comply with HIPAA standards, which are codified at 45 CFR parts 160, 162, and 164. Because of the wide variety of healthcare providers subject to HIPAA, the requirements are general to allow the providers to adopt protections that are appropriate for their situations. For example, the security steps needed at a one-practitioner office will be very different from those needed at a large hospital system or chain pharmacy system. The DEA rule being issued here is consistent with HIPAA security guidance issued by HHS, as explained later in this document. Because both DEA and HHS are involved in addressing electronic prescriptions, they held a joint public meeting on July 11 and 12, 2006, to gather information from the regulated community (practitioners and pharmacies) as well as from the prescription and pharmacy service providers, technical experts, and Federal, State, and local law enforcement. The meeting record is available at *http://www.deadiversion.usdoj.gov/ecomm/e_rx/mtgs/july2006/index.html* . Based on the meeting and on the requirements of the CSA and the other applicable provisions of law outlined above, DEA has developed this proposed rule. As the proposed rule illustrates, DEA supports the adoption of electronic prescriptions for controlled substances in a manner that will minimize the risk of diversion. In the absence of appropriate controls, allowing electronic prescriptions for controlled substances could exacerbate the already increasing problem of prescription controlled substance abuse in the United States, as discussed further below. It is also essential that the rules governing the electronic prescribing of controlled substances do not undermine the ability of DEA, State, and local law enforcement to identify and prosecute those who engage in diversion. The remainder of this preamble for the rule is organized as follows: Section II discusses the framework of pertinent provisions of the CSA and DEA regulations to provide a context for this proposed rule. Section III describes the current requirements for controlled substance prescriptions. Section IV discusses the existing electronic prescription and pharmacy systems. Section V discusses potential vulnerabilities that need to be addressed to prevent electronic prescribing from contributing to the diversion of controlled substances. Section VI discusses alternatives considered. Section VII discusses the risk assessment DEA conducted regarding electronic prescriptions for controlled substances. Section VIII describes the proposed rule and the rationale for the requirements DEA is proposing to impose on prescription and pharmacy systems that create, process, and archive controlled substance prescriptions. Section IX provides a summary of the proposed rule requirements and their current implementation status. Section X is a section-by-section analysis of the proposed rule. Section XI describes a system for the electronic prescribing of controlled substances that DEA is proposing specifically for use by Federal health care agencies (including the United States Army, Navy, Marine Corps, Air Force, Coast Guard, Department of Veterans Affairs, Public Health Service, and Bureau of Prisons). These agencies would be permitted to use either system for controlled substances prescribing and dispensing. Section XII discusses the incorporation by reference of one standard published by the National Institute of Standards and Technology. Section XIII presents the required analyses on the economic and other impacts of the proposed rule. II. Framework of the Pertinent Provisions of the CSA and DEA Regulations In enacting the CSA, Congress sought to control the diversion of pharmaceutical controlled substances into illicit markets by establishing a “closed system” of drug distribution governing the legitimate handlers of controlled substances. H. Rep. No. 91-1444, *reprinted in* 1970 U.S.C.C.A.N. 4566, 4571-72. Under this closed system, all legitimate manufacturers, distributors, and dispensers of controlled substances must register with DEA and maintain strict accounting for all controlled substance transactions *(Id.)* . The CSA defines “dispense” to include, among other things, the issuance of a prescription by a practitioner as well as the delivery of a controlled substance to a patient by a pharmacy pursuant to a prescription (21 U.S.C. 802(10)). Thus, both practitioners who prescribe controlled substances and pharmacies that fill such prescriptions must obtain a DEA registration (21 U.S.C. 822(a)(2)). The CSA definition of practitioner (21 U.S.C. 802(21)) includes, among others, physicians, dentists, veterinarians, pharmacies, and, where authorized by an appropriate State authority, physician assistants and advance practice nurses. It is important to reiterate here that DEA registers pharmacies, as opposed to pharmacists. As a rule, pharmacists themselves do not have the authority to independently prescribe controlled substances. Rather, pharmacists rely on the prescription, as written by the individual practitioner, for authority to conduct the dispensing. Under longstanding Federal law, for a prescription for a controlled substance to be valid, it must be issued for a legitimate medical purpose by a practitioner acting in the usual course of professional practice ( *United States* v. *Moore, 423 U.S. 122 (1975)* ; 21 CFR 1306.04(a)). As the DEA regulations state: “The responsibility for the proper prescribing and dispensing of controlled substances is upon the prescribing practitioner, but a corresponding responsibility rests with the pharmacist who fills the prescription.” (21 CFR 1306.04(a)). The CSA provides that a controlled substance in Schedule II may only be dispensed by a pharmacy pursuant to a “written prescription,” except in emergency situations (21 U.S.C. 829(a)). In contrast, for controlled substances in Schedules III and IV, the CSA provides that a pharmacy may dispense pursuant to a “written or oral prescription.” (21 U.S.C. 829(b)). Where an oral prescription is permitted by the CSA, the DEA regulations further provide that a practitioner may transmit to the pharmacy a facsimile of a written prescription in lieu of an oral prescription (21 CFR 1306.21(a)). Enforcement of the Controlled Substances Act The Controlled Substances Act is unique among criminal laws in that it stipulates acts pertaining to controlled substances that are permissible. That is, if the CSA does not explicitly permit an action pertaining to a controlled substance, then by its lack of explicit permissibility the act is prohibited. Violations of the Act can be civil or criminal in nature, which may result in administrative, civil, or criminal proceedings. Remedies under the Act can range from modification or revocation of DEA registration, to civil monetary penalties or imprisonment, depending on the nature, scope, and extent of the violation. Specifically, it is unlawful for any person knowingly or intentionally to manufacture, distribute, or dispense, a controlled substance or to possess a controlled substance with the intent of manufacturing, distributing, or dispensing that controlled substance, except as authorized by the Controlled Substances Act (21 U.S.C. 841(a)(1)). Further, it is unlawful for any person knowingly or intentionally to possess a controlled substance unless such substance was obtained directly, or pursuant to a valid prescription or order, issued for a legitimate medical purpose, from a practitioner, while acting in the course of the practitioner's professional practice, or except as otherwise authorized by the CSA (21 U.S.C. 844(a)). It is unlawful for any person to knowingly or intentionally acquire or obtain possession of a controlled substance by misrepresentation, fraud, forgery, deception, or subterfuge (21 U.S.C. 843(a)(3)). It is unlawful for any person knowingly or intentionally to use a DEA registration number that is fictitious, revoked, suspended, expired, or issued to another person in the course of dispensing a controlled substance, or for the purpose of acquiring or obtaining a controlled substance (21 U.S.C. 843(a)(2)). Beyond these possession and dispensing requirements, it is unlawful for any person to refuse or negligently fail to make, keep, or furnish any record (including any record of dispensing) that is required by the CSA (21 U.S.C. 842(a)(5)). It is also unlawful to furnish any false or fraudulent material information in, or omit any information from, any record required to be made or kept (21 U.S.C. 843(a)(4)(A)). Within the CSA's system of controls, it is the individual practitioner (e.g., physician, dentist, veterinarian, nurse practitioner) who issues the prescription authorizing the dispensing of the controlled substance. This prescription must be issued for a legitimate medical purpose and must be issued in the usual course of professional practice. The individual practitioner is responsible for ensuring that the prescription conforms to all legal requirements. The pharmacist, acting under the authority of the DEA-registered pharmacy, has a corresponding responsibility to ensure that the prescription is valid and meets all legal requirements. The DEA-registered pharmacy does not order the dispensing. Rather, the pharmacy, and the dispensing pharmacist, merely rely on the prescription as written by the DEA-registered individual practitioner to conduct the dispensing. Thus, a prescription is much more than the mere method of transmitting dispensing information from a practitioner to a pharmacy. The prescription serves both as a record of the practitioner's determination of the legitimate medical need for the drug to be dispensed, and as a record of the dispensing, providing the pharmacy with the legal justification and authority to dispense the medication prescribed by the practitioner. The prescription also provides a record of the actual dispensing of the controlled substance to the ultimate user (the patient) and, therefore, is critical to documenting that controlled substances held by a pharmacy have been dispensed legally. The maintenance by pharmacies of complete and accurate prescription records is an essential part of the overall CSA regulatory scheme established by Congress, wherein all those within the legitimate distribution chain must strictly account for all controlled substances on hand, as well as those received, sold, delivered, or otherwise disposed of (21 U.S.C. 827). The CSA recordkeeping requirements for prescriptions are somewhat unusual in that the practitioner is not required to maintain a record of prescriptions written; instead, the record is held only by the pharmacy. Abuse of Controlled Substances The level of control mandated by Congress for controlled substances far exceeds that for other prescription drugs commensurate with the facts that controlled substances can cause physical and psychological dependence and have historically been abused. Several studies of drug abuse patterns indicate that nonmedical use of prescription controlled substances (those in Schedules II through V) is an increasing problem even as the use of certain Schedule I substances appears to have declined somewhat in recent years. The National Survey on Drug Use and Health (NSDUH) (formerly the National Household Survey on Drug Abuse) is an annual survey of the civilian, non-institutionalized, population of the United States aged 12 or older. The survey is conducted by the Office of Applied Studies, Substance Abuse and Mental Health Services Administration, of the Department of Health and Human Services. Findings from the 2006 NSDUH were released in September 2007 and are the latest year for which information is currently available. The 2006 NSDUH 1 estimated that 20.4 million Americans were classified with substance dependence or abuse (8.3 percent of the total population aged 12 or older). Further, the 2006 NSDUH estimated that 6.7 million persons were current users, i.e., past 30 days, of psychotherapeutic drugs—pain relievers, anti-anxiety medications, stimulants, and sedatives—taken nonmedically. This represents 2.8 percent of the population aged 12 or older. Specifically, the NSDUH estimated that 5.2 million persons used pain relievers, 1.8 million used tranquilizers, 1.2 million used stimulants, and 0.4 million used sedatives. Except for tranquilizers, these estimates are increases from the corresponding estimates for 2005. 1 Substance Abuse and Mental Health Services Administration. (2007). *Results From the 2006 National Survey on Drug Use and Health: National Findings* (Office of Applied Studies, NSDUH Series H-32, DHHS Publication No. SMA 07-4293). Rockville, MD. *http://www.oas.samhsa.gov/nhsda.htm* . According to the NSDUH, more than 20 percent of persons age 12 or older have used psychotherapeutic drugs nonmedically in their lifetime. Overall, 33 million Americans are estimated to have used prescription pain killers for nonmedical reasons in their lifetime. Specific pain relievers with statistically significant increases in lifetime use for 18 to 25 year olds between 2003 and 2006 were the Schedule III controlled substances Vicodin®, Lortab®, or Lorcet® (from 15.0 percent to 18 percent); Schedule III controlled substances containing hydrocodone (from 16.3 percent to 19.2 percent); the Schedule II controlled substance OxyContin® (from 3.6 percent to 5.1 percent); and the Schedule II controlled substances containing oxycodone (from 8.9 percent to 10.8 percent). Results of a separate study of seventh through twelfth grade students were released April 21, 2005, by the Partnership for a Drug-Free America. The Partnership Attitude Tracking Study 2 tracks consumers' exposure to and attitudes about drugs. The study focuses on perceived risk and social attitudes. For the first time in its seventeen-year history, the study found that teenagers are more likely to have abused a prescription pain medication to get high than they are to have experimented with a variety of illicit drugs including Ecstasy, cocaine, crack and LSD. In 2004, the study reported that nearly one in five teenagers, 18 percent, or 4.3 million teenagers nationally, indicated they have used the Schedule III controlled substance Vicodin® without a prescription. Approximately ten percent of teens, or 2.3 million teens nationally, reported using the Schedule II controlled substance OxyContin® without a prescription. Further, the study reported that ten percent, or 2.3 million teenagers nationally, reported having used prescription stimulants, Ritalin® and/or Adderall®, without a prescription. The 2005 survey indicated that 50 percent of the teenagers surveyed indicated that prescription drugs are widely available; a third indicated that they were easy to purchase over the Internet. 2 Partnership for a Drug-Free America; Partnership Attitude Tracking study, 2005; *http://www.drugfree.org/Portal/DrugIssue/Research/* . The 2006 National Institute of Drug Abuse survey of drug use by teens in the eighth, tenth, and twelfth grades, Monitoring the Future: National Results on Adolescent Drug Use 3 , found that past-year nonmedical use of Vicodin® (Schedule III) remained high among all three grades, with nearly one in ten high school seniors using it in the past year. Despite a drop from 2005 to 2006 in past-year abuse of OxyContin® among twelfth graders (from 5.5 percent to 4.3 percent), there has been no such decline among the eighth and tenth grade students, and the rate of use among the youngest students has increased significantly since it was included in the survey in 2002. 3 Johnston, L. D., O'Malley, P. M., Bachman, J. G., and Schulenberg, J. E. (2007). *Monitoring the Future national results on adolescent drug use: Overview of key findings, 2006.* (NIH Publication No. 07-6202). Bethesda, MD: National Institute on Drug Abuse; *http://www.monitoringthefuture.org/pubs.html* . The consequences of prescription drug abuse are seen in the data collected by the Substance Abuse and Mental Health Services Administration on emergency room visits. In the latest data, Drug Abuse Warning Network (DAWN), 2005: National Estimates of Drug-Related Emergency Department Visits, 4 SAMHSA estimates that about 599,000 emergency department visits involved nonmedical use of prescription or over-the-counter drugs or dietary supplements, a 21 percent increase over 2004. Of the 599,000 visits, 172,000 involved benzodiazepines (Schedule IV) and 196,000 involved opiates (Schedule II and III). Overall, controlled substances represented 66 percent of the estimated emergency department visits. Between 2004 and 2005, the number of visits involving opiates increased 24 percent and the number involving benzodiazepines increased 19 percent. About a third (200,000) of all visits involving nonmedical use of pharmaceuticals resulted in admission to the hospital; about 66,000 of those individuals were admitted to critical care units; 1,365 of the visits ended with the death of the patient. More than half of the visits involved patients 35 and older. 4 Substance Abuse and Mental Health Services Administration, Office of Applied Studies. * Drug Abuse Warning Network, 2005: National Estimates of Drug-Related Emergency Department Visits * . DAWN Series D-29, DHHS Publication No.

(SMA)07-4256, Rockville, MD, 2007; *http://dawninfo.samhsa.gov/pubs/edpubs/default.asp* . Means by Which Controlled Substances Are Diverted Understanding the means by which controlled substances are diverted is critical to determining appropriate regulatory controls. Diversion of prescription controlled substances can occur in a number of ways, including, but not limited to, the following: • Prescription pads are stolen from practitioners' offices by patients, staff, or others and illegitimate prescriptions are written. • Legitimate prescriptions are altered to obtain additional amounts of legitimately prescribed controlled substances. • Drug-seeking patients may falsify symptoms and/or obtain multiple prescriptions from different practitioners for their own use or for resale. In some cases, organized groups visit practitioners with fake symptoms to obtain prescriptions, which are filled and resold. Some patients resell their legitimately obtained drugs to earn extra money. • Prescription pads containing legitimate practitioner information (e.g., name, address, DEA registration number) are printed with a different call back number that is answered by an accomplice to verify the prescription. • Computers and scanning or copying equipment are used to create prescriptions for nonexistent practitioners or to copy legitimate practitioners' prescriptions. • Pharmacies and other locations where controlled substances are stored are robbed or burglarized. Diversion from within the practitioner's practice or pharmacy may also occur, such as in the following situations: • Prescriptions are written for other than a legitimate medical purpose. Some practitioners knowingly write prescriptions for nonmedical purposes. Criminal organizations commonly referred to as “rogue Internet pharmacies” often employ practitioners to issue prescriptions based on online questionnaires from patients with whom the practitioner has no legitimate medical relationship. • Controlled substances are stolen from a pharmacy by pharmacy personnel. Legitimately dispensed prescriptions may be altered to make the thefts less detectable. • Legitimate prescriptions may be stolen from legitimate patients. The stolen legitimate prescriptions may be filled by persons addicted to or abusing controlled substances. Given these common methods of diversion, as well as the alarmingly increasing extent of prescription controlled substance abuse in the United States, many of those at the DEA/HHS public meeting in 2006, particularly representatives of Federal and state law enforcement and regulatory agencies, emphasized that any system allowing the electronic prescribing of controlled substances must have sufficient safeguards to prevent contributing further to the diversion problem in this country. Indeed, this is true regardless of the means used to divert controlled substances in the paper-based system, because electronic prescribing of controlled substances could, if not properly implemented, present another means of diversion in addition to those listed above. However, with proper controls, the risk of diversion can actually be reduced through the use of electronic prescriptions. Among the essential elements of such a system are ensuring that only DEA registrants electronically sign and authorize controlled substance prescriptions and that the prescription record cannot be altered without the alteration being detectable. A system that fails to provide verification of the signer's identity and authority to issue controlled substance prescriptions, and/or fails to ensure that alteration of the record is detectable, would create new routes of diversion that could be even harder to prevent and detect. III. Current Requirements for Prescriptions for Controlled Substances As noted above, the CSA requires that, except in limited emergency circumstances, a pharmacist may only dispense a Schedule II controlled substance pursuant to a written prescription from a practitioner (21 U.S.C. 829(a)). For Schedule III and IV controlled substances, a pharmacist may dispense the controlled substance pursuant to a written or oral prescription from a practitioner (21 U.S.C. 829(b)). Every written prescription must be signed by the practitioner in the same way the practitioner would sign a check or other legal document, e.g., “John H. Smith” or “J.H. Smith” (21 CFR 1306.05). A prescription for a controlled substance may be issued only by an individual practitioner who is authorized to prescribe by the State in which he is licensed to practice and is registered, or exempted from registration, with DEA (21 U.S.C. 822, 823). To be valid, a prescription must be written for a legitimate medical purpose by an individual practitioner acting in the usual course of professional practice; a corresponding responsibility rests with the pharmacist who fills the prescription (21 CFR 1306.04). An order purporting to be a prescription issued not in the usual course of professional treatment is not a prescription within the meaning and intent of the Controlled Substances Act, and the person knowingly filling such a purported prescription, as well as the person issuing it, is subject to the penalties provided for violations of the provisions of law relating to controlled substances. Longstanding DEA regulations specify that each controlled substance prescription contain certain information including the practitioner's manual signature (21 CFR 1306.05). The manual signature affixed to the controlled substance prescription by the practitioner serves as formal attestation by the practitioner that the prescription has been written for a legitimate medical purpose and affirms the practitioner's authority to prescribe the controlled substance in question. The prescribing practitioner is responsible in case the prescription does not conform in all essential respects to the law and regulations. Further, a corresponding liability rests upon the pharmacist who fills a prescription not prepared in the form prescribed by DEA regulations (21 CFR 1306.05). A prescription may be filled only by a pharmacist acting in the usual course of professional practice who is employed in a registered pharmacy (21 CFR 1306.06). Except under limited circumstances, a pharmacist may dispense a Schedule II controlled substance only upon receipt of the original written prescription manually signed by the practitioner (21 U.S.C. 829, 21 CFR 1306.11). A pharmacist may dispense a Schedule III or IV controlled substance only pursuant to a written and manually signed prescription from an individual practitioner, which is presented directly or transmitted via facsimile to the pharmacist, or an oral prescription, which the pharmacist promptly reduces to writing containing all of the information required to be in a prescription, except the signature of the practitioner (21 U.S.C. 829, 21 CFR 1306.21). Every prescription must be initialed and dated by the pharmacist filling the prescription (21 CFR 1304.22(c)). Under many circumstances, pharmacists are required to note certain specific information regarding dispensing on the prescription or recorded in a separate document referencing the prescription before the prescription is placed in the pharmacy's prescription records. DEA requires the registered pharmacy to maintain records of each dispensing for two years from the date of dispensing of the controlled substance (21 U.S.C. 827(b), 21 CFR 1304.04). However, many States require that these records be maintained for longer periods of time. These records must be made available for inspection and copying by authorized employees of DEA (21 U.S.C. 827(b)). This system of records is unique in that the prescribing practitioner creates the prescription, but the dispensing pharmacy retains the record. The signature requirement for written prescriptions for controlled substances provides DEA with reliable evidence needed to enforce the CSA in administrative, civil, and criminal legal proceedings. In criminal proceedings for violations of the CSA, the Government must prove the violation beyond a reasonable doubt. As the agency responsible for monitoring compliance with the regulatory requirements of the CSA, it is essential that DEA have the ability to determine whether a given prescription for a controlled substance was, in fact, signed by the practitioner whose name appears on the prescription. It is likewise essential that DEA have the ability to determine that a prescription that has been filled by a pharmacy was not altered after it was prepared by the practitioner. Further, because DEA relies on the records of these prescriptions in the conduct of investigations, DEA must also know that the prescription has not been altered after receipt by the pharmacy. The elements of the prescription that identify the practitioner (the practitioner's name, address, DEA registration number, and signature) also serve to enable the pharmacy to authenticate the prescription. If a pharmacy is unfamiliar with the practitioner, it can use the registration number to verify the identity of the practitioner through publicly available records. Those same records would indicate to the pharmacy whether the practitioner has the authority to prescribe the schedule of the controlled substance in question. Requiring that the original documents be maintained in paper form serves to support both the accuracy and integrity of each record and, thus, the accuracy and integrity of the system of records as a whole. The availability of the original written and manually signed prescription provides a level of document integrity and provides physical evidence if the record has been altered: alterations of a hard-copy record are usually apparent upon close examination. A forensic examination of a prescription can prove that a practitioner signed it or, equally important, that the practitioner did not sign it. The maintenance of the paper record at a pharmacy also ensures that State and local law enforcement agencies have access to records they need for investigations. In addition, there will be a limited number of pharmacy employees who will have annotated the record and can testify that the prescription is, in fact, the prescription they received and dispensed. IV. Existing Electronic Prescription Systems At present, there are more than 110 service providers that offer systems to generate electronic prescriptions and approximately 20 that handle the receipt of prescriptions at pharmacies. 5 The electronic capabilities of practitioners' offices and pharmacies and the systems used are considerably different. Both types of systems, however, can be classified in the same ways. Systems may be stand-alone software that only handle prescriptions or integrated into larger management systems. In general, pharmacy systems are part of larger pharmacy management systems. Most electronic prescription systems are now integrated into larger electronic health records

(EHR)systems; existing stand-alone systems may be integrated into EHR systems in the future. 6 7 5 Estimates are based on the number of systems certified by SureScripts plus the number of electronic medical record systems certified by the Certification Commission for Health Information Technology. 6 National Alliance on Health Information Technology, “Report to the office of the National Coordinator on Health Information Technology on Defining Key Health Information Technology Terms”, April 28, 2008. *http://www.nahit.org/cms/images/docs/hittermsfinalreport_051508.pdf* . 7 The National Alliance for Health Information Technology has defined the terms “electronic Medical record (EMR),” “electronic health record (EHR),” and “personal health record (PHR).” Both EMRs and EHRs are defined to be maintained by practitioners, whereas a PHR is defined to be maintained by the individual patient. The main distinction between an EMR and an EHR is the EHR's ability to exchange information interoperably. DEA's use of the term EHR in this rule relates to those records maintained by practitioners, as opposed to a PHR maintained by an individual patient, regardless of how those records are maintained. Systems may also be installed on a practice or pharmacy computers or may be operated by application service providers (ASPs). In the ASP model, the program is retained on the ASP servers and the user accesses the system using leased lines or over the Internet. The ASP retains the records generated. Many pharmacy systems are installed at the pharmacy, but larger chains often operate like an ASP, holding the records on a central server that any pharmacy in the chain may access. Many practitioner stand-alone electronic prescription systems are ASPs. Because practitioners want to be able to access the system when they are out of the office, access is usually over the Internet. Practitioners log on to the system using the same kinds of identification mechanisms as other online business sites (passwords, user IDs). *Pharmacy Systems* . Almost all pharmacies have computerized prescription records, which are integrated into overall pharmacy management systems that process insurance claims and billings. When a pharmacy receives a prescription on paper or by phone, the pharmacist or technician keys the information on the prescription into the system; if the patient has had other prescriptions filled at that pharmacy, the patient's personal identifying information is already in the system and does not have to be rekeyed. Many pharmacy systems have been reprogrammed to be able to capture the data from electronic prescriptions directly. Although many pharmacies have the ability to accept electronic prescriptions, few such prescriptions are sent currently. Many of the “electronic prescriptions” generated are in fact transmitted to the pharmacy as faxes or simply printed out and given to the patient. Renewals are more likely to be handled electronically than original prescriptions. Nonetheless, the capability to accept electronic prescriptions is widespread in the pharmacy sector. *Practitioner Electronic Prescription Systems* . Electronic prescription systems for practitioners have existed for a number of years, but are still not widely used. A Centers for Disease Control and Prevention

(CDC)study of electronic medical record

(EMR)system use in 2006 found that about 12 percent of physicians have the ability to send prescriptions electronically using their EMR system. 8 The number of those systems that are used or that generate true electronic prescriptions is unclear. A Rand Health study of 58 electronic prescribing systems found that only 58 percent allowed electronic transmission of the prescriptions (as a data file), while almost all produced printed prescriptions and most could generate faxes. 9 The CDC study indicated that the electronic prescribing function is one of the less used functions of EMRs. 8 Centers for Disease Control and Prevention, “Electronic Medical Record Use by Office-Based Physicians and Their Practices: United States 2006.” *Advance Data from Vital and Health Statistics* , Number 393, October 26, 2007. 9 Wang, C. Jason *et al.* , “Functional Characteristics of Commercial Ambulatory Electronic Prescribing Systems: A Field Study,” *Journal of the American Medical Informatics Association* , 2005; 12:346-356. As noted above, many electronic prescription systems are Web-based ASPs. The ASP maintains the records, which reduces the initial cost to the practice by limiting the investment in hardware and connections. The ASP enrolls a practice, issues keys or sets up other authentication mechanisms, which allow the practitioner to log onto the system from any location. Most ASP systems and some installed systems can be accessed using PDAs and other handheld devices. Because many office staff may need to access the systems, many service providers also set different levels of authority so that only practitioners may sign prescriptions; the ability to support varying access levels is a requirement for EHR certification for systems certified by the Certification Commission for Healthcare Information Technology (CCHIT). Over the long term, it is generally assumed that stand-alone electronic prescription systems will be integrated into or replaced by electronic health record

(EHR)systems. In this way, data on prescriptions will be automatically added to a patient's records. This shift to EHRs is occurring rapidly. Of the 119 systems certified by SureScripts or CCHIT at the end of 2007, 103 were EHRs. DEA welcomes comments on the protections currently implemented in the systems referenced above to protect against noncontrolled substance prescription forgery, fraud, and other related crimes, and what risk-mitigating controls are in place. DEA also seeks comment as to whether up-to-date information or statistics are available regarding physicians' ability to send noncontrolled substance prescriptions electronically using their EHR systems and usage of such system functionality. When providing comments regarding this or any other request in this NPRM, commenters should clearly cite the source of the information, the origin of the data, the methodology or analytical techniques used to derive the information, and the limitations of the information, so that DEA may determine the quality, objectivity, utility, and integrity of any data or information provided. *Intermediaries* . With so many electronic prescription systems and pharmacy systems, the issue of interoperability is critical. Electronic prescriptions will be of limited value to pharmacies if their systems cannot read the prescription and translate the data directly into their databases. To deal with this issue, the National Council for Prescription Drug Programs (NCPDP) has established a standard format for prescriptions, NCPDP SCRIPT standard in XML (current version is 10, but version 8.1 is the standard that Medicare specifies). Despite the standard, interoperability problems are likely to continue as both practitioner and pharmacy systems may be using different platforms and different versions of SCRIPT. At present, the interoperability problem is solved by using intermediaries that reformat the prescription so that the receiving pharmacy will be able to process it electronically. Electronic prescriptions are transmitted through not one, but a series of intermediaries. The first recipient, once the prescription is signed, may be the ASP or an aggregator that the electronic prescription system uses. This recipient assigns a trace number to the electronic prescription that becomes part of the prescription record. The ASP or aggregator generally will transmit it to SureScripts or a similar intermediary. SureScripts is a service established by the pharmacy industry to reformat the prescriptions so the receiving pharmacy's system can process them without rekeying the information. SureScripts certifies both pharmacy and practitioner service providers, to ensure that the data it receives will be translatable into other formats. SureScripts may transmit the reformatted electronic prescription directly to a pharmacy, the central server of a chain pharmacy, or the ASP pharmacy management system, which then routes the prescription to the pharmacy for ultimate dispensing. DEA welcomes comments on the protections currently implemented by intermediaries to protect against noncontrolled substance prescription forgery, fraud, and other related crimes, and what risk-mitigating controls are in place. DEA also welcomes comments regarding the current standards and practices used by network intermediaries to route noncontrolled substance electronic prescriptions and whether such networks allow or provide the capability to “open” an electronic prescription that is en route. *Hospitals* . A final complexity to the electronic prescription network arises from practitioners who serve on the staff of hospitals. Two technical issues exist with any electronic prescriptions these practitioners may write. First, hospital electronic record systems are written in computer languages other than SCRIPT, often HL7. If a staff practitioner writes an electronic prescription for a patient to fill at a pharmacy outside of the hospital, the intermediaries or pharmacies have to be able to translate the electronic prescriptions from HL7 to their own computer system language. Second, staff practitioners are not required to register with DEA. They are allowed to issue prescriptions under the hospital DEA registration number with a hospital-assigned extension that identifies the specific person issuing the prescription. DEA does not dictate the format of the extension. In at least some cases, pharmacy computer systems have not been able to handle the extensions. V. Potential Vulnerabilities That Need To Be Addressed To Prevent Electronic Prescribing From Contributing to the Diversion of Controlled Substances Many parties in the healthcare industry are encouraging the adoption of electronic prescriptions because such prescriptions have the potential to improve patient safety by eliminating medical errors that arise from misread or misunderstood prescriptions and eliminating adverse events that result from drug interactions. They can also control costs by ensuring that more drugs prescribed are covered by formularies or are generic versions. Although DEA also supports electronic prescribing, the Administration faces some challenges as it moves into an electronic world. A recent study conducted for HHS by the American Health Information Management Association 10 noted that “e-prescribing presents a new vulnerability because of the increased velocity of authenticated automated transactions.” Unless an electronic prescription system is properly designed, DEA's ability to prevent diversion and take legal action against those who violate the CSA could be seriously undermined. 10 American Health Information Management Association, “ *Report on the Use of Health Information Technology to Enhance and Expand Health Care Anti-Fraud Activities,* ” [September 2005] p. 45. As discussed above, with the paper-based system, the paper records provide DEA and other law enforcement agencies with documents that can be used in legal actions to prove that a practitioner has issued prescriptions for other than legitimate medical purposes, that others have forged prescriptions, or that pharmacy records or inventories are inconsistent with prescriptions received. The necessity for presenting prescriptions to pharmacies and picking up the drugs also limits the scope of diversion when it occurs. In contrast, electronic prescriptions can be easy to create, transmit, and alter, often without leaving a trail that links the person forging or altering a prescription to the record. Not only practice and pharmacy staff, but also staff at any of the systems involved in creating, transmitting, and processing prescriptions could generate or alter prescriptions. With the Internet and mail order pharmacies, those bent on diversion gain the ability to send prescriptions to a large number of pharmacies with a few keystrokes. DEA's concerns with the existing electronic prescription system are the following: • Service providers do not always determine whether the people enrolling are legally permitted to issue prescriptions, let alone controlled substance prescriptions. Some service providers appear to enroll practices over the Internet; some require submission of copies of the person's DEA registration and State license. Such procedures provide no assurance that authority to issue controlled substance electronic prescriptions will not be granted to people who are not DEA registrants. The DEA registrant list, including DEA registration numbers, is publicly available. The DEA number also appears on each controlled substance prescription and in many cases is preprinted on prescription pads so that any patient receiving a prescription for any drug, regardless of whether it is a controlled substance, will have access to the number. State license information is readily accessible from online State databases. Office staff may have access to the originals to copy. Copies of registration and license certificates would be easy to generate and submit. Present service provider procedures do not protect a practitioner from someone inside or outside the practitioner's practice setting up an account and creating fraudulent prescriptions in the practitioner's name. Moreover, current system designs could also allow a practitioner to repudiate prescriptions written for the purpose of diversion. • Some systems may not limit who within a medical practice can “sign” prescriptions. Many staff at practices may have legitimate needs to access the system; only some have a legal right to sign prescriptions. Unless systems limit the “signing” function to practitioners with a legal right to issue prescriptions and provide unique identifiers that make it possible to determine who signed the prescription, taking enforcement action against practitioners who issue illegal prescriptions will be impossible because DEA will not be able to prove beyond a reasonable doubt who signed the prescription. This problem is exacerbated because “signing” in an electronic prescription system is a function that is usually nothing more than a keystroke that indicates that the prescription is complete; there is no “signature” applied to the prescription. In some cases, there may not be a “signing” function, but simply a command to transmit. (The SCRIPT standard does not currently provide a field for an electronic signature or an indication that the prescription has been signed.) • Access to systems is usually by means of easily shared or stolen information (passwords, user IDs). As William Winsley, Executive Director of the Ohio Board of Pharmacy testified at the DEA/HHS July 2006 public meeting, “Passwords are useless as a means of computer security in a healthcare setting.” Too many people are in the vicinity of computers in practice offices to be certain that a password has not been compromised. If passwords or PINs are the only means of authentication for an electronic prescription system, law enforcement agencies will not be able to prove beyond a reasonable doubt who signed an electronic prescription. Practitioners will be able to repudiate prescriptions by saying that someone must have used their passwords. • Once created and signed, electronic prescriptions pass through several intermediaries, all of which may open the record. Although this process is usually handled without individuals accessing the record, there is no guarantee that they could not do so. Most identity theft occurs not from people hacking into systems, but rather from insiders who know how to manipulate the system. Paul Donfried of SAFE BioPharma 11 and Strategic Identity Group noted at the July 2006, DEA/HHS public meeting: “It generally is not the cryptography or the firewalls or the audit logs or the data centers that people attack. It is whatever the weak link in the chain is, which normally is the human beings who are responsible for keeping the stuff running and operating correctly.” 11 SAFE BioPharma is an organization “that created and manages the SAFE digital identity and signature standard for the pharmaceutical and healthcare industries.” • The processing of the prescriptions by multiple parties could mean that law enforcement would have to prove that none of the parties altered the document. This requirement could substantially increase the cost of bringing cases against registrants who are diverting controlled substances as well as burden the service providers and intermediaries, which would have to produce audit trail records and experts to testify. • The records of the prescriptions are often held by the service providers and intermediaries, not the pharmacies. With paper records, DEA and other law enforcement agencies have the right to inspect and remove records from pharmacies. With electronic records held by service providers and others, DEA and other agencies would have to subpoena records from the third parties—nonregistrants over whom law enforcement may have limited jurisdiction. Although this is a lesser problem for DEA, it could pose a substantial barrier to State and local law enforcement, which would be in the position of having to find other agencies willing to serve subpoenas on service providers who were located in other States. • Records of electronic prescriptions at pharmacies and at intermediaries may be stored as strings of data, not as easily read text. These records must be able to be downloaded into a format that is easily read and manipulated by law enforcement. DEA is convinced that its concerns can be addressed without creating insurmountable barriers to electronic prescribing. DEA's requirements in developing this proposed rule are the following: • The approach must meet DEA's statutory mandates. Only DEA registrants may be granted the authority to sign controlled substance electronic prescriptions. • The method used to authenticate a practitioner to the electronic prescribing system must ensure to the greatest extent possible that the practitioner cannot repudiate the prescription. Authentication methods that can be compromised without the practitioner being aware of the compromise are not acceptable. • Electronic prescriptions must include all information required for paper controlled substance prescriptions. • The prescription records must be reliable enough to be used in legal actions without having to substantially expand the number of witnesses that need to be called to verify records. • The pharmacy system must allow annotation of the records as required for paper prescriptions and must indicate who made each annotation. • The security systems used by any of the service providers must, to the greatest extent possible, prevent the possibility of insider creation or alteration of controlled substance prescriptions. In addition, DEA wishes to adopt an approach that is flexible enough that future changes in technologies will not make the system obsolete or lock registrants into more expensive systems. DEA notes that its requirements do not relate to most of the functions of electronic prescribing systems. Other than requiring that the electronic prescription contain the basic information that any controlled substance prescription must contain (and that most prescriptions contain), DEA is not concerned about the format or transmission standards, or any of the added functions (formulary checks, clinical support, medication histories) available in electronic prescribing systems. Further, as DEA notes throughout this document, the electronic prescribing of controlled substances is in addition to, not a replacement of, existing requirements for written and oral prescriptions for controlled substances. This proposed rule would provide a new option to prescribing practitioners and pharmacies. It does not change existing regulatory requirements for written and oral prescriptions for controlled substances. Prescribing practitioners will still be able to write, and manually sign, prescriptions for Schedule II, III, IV, and V controlled substances, and pharmacies will still be able to dispense controlled substances based on those written prescriptions and archive those records of dispensing. VI. Alternatives Considered In developing this rule, DEA considered a range of alternatives, from imposing virtually no requirements on existing systems to requiring systems using public key infrastructure. This section discusses the options considered and why DEA rejected some of them. *Allowing the use of any existing electronic prescription system without additional security.* DEA considered whether to permit electronic prescribing of controlled substances using existing systems without any additional requirements. This would be the alternative most supported by service providers of existing electronic prescribing systems, as it would require no system modifications and would allow for the electronic prescribing of controlled substances as soon as a Final Rule permitting this activity became effective. Some have suggested that DEA permit the use of any existing system; if that system is used for diversion, DEA could then tighten its regulations later. In discussing this alternative, and to understand why DEA rejected it, it first must be noted that any electronic prescribing systems currently being utilized are generally limited to noncontrolled substances as DEA regulations currently do not allow for the electronic prescribing of controlled substances. 12 Thus, any systems currently in place were not specifically tailored to the unique concerns relating to controlled substances—most notably the heightened need to prevent diversion of controlled substances as compared to noncontrolled substances. It is also important to understand the following regarding the current systems used to create, transmit, and process electronic prescriptions. 12 DEA has granted an exception to its regulations to allow the United States Department of Veterans Affairs to conduct a pilot program involving the electronic prescribing of controlled substances using a system based on public key infrastructure

(PKI)technology. PKI-based systems are discussed in greater detail later in this document. As discussed above, there are more than 100 vendors marketing systems to practitioners and about 20 marketing systems to pharmacies. These vendors range from start-ups with revenues of less than $1 million to a few very large corporations. There are at present no requirements for how these systems enroll practitioners, no requirements that they verify that the person enrolling is who he claims to be or is eligible to sign prescriptions. Some systems offer enrollment over the Internet. There are no requirements that prescriptions be signed only by someone authorized under State law to do so. Some systems set access controls; others appear to grant general access to everyone in the office; in these systems, the prescription cannot be linked to a single practitioner. Many, perhaps most, of these systems allow access to prescription signing using nothing more than a password or a password/user ID, forms of identification that are easily compromised, especially in a healthcare setting where multiple staff use the same computers. Prescriptions could be created by anyone and signed by anyone. Some systems appear to rely on the good intentions of the practitioners' staff, a reliance that the high degree of insider medical identity theft and insider prescription forgery renders naïve at best. There are no standards governing the security of the transmission of electronic prescribing systems currently being utilized. Therefore, while some of the intermediaries that handle prescriptions between the practitioner and pharmacy might have voluntarily implemented effective security measures, they are not legally obligated to do so and—in the absence of binding regulatory requirements—there is no way to ensure that they or others who might enter the market will have effective measures in the future. The intermediaries (up to five per transmission) are not required to keep records or audit trails although the best of them do. As ever, the weakest link can undermine the entire system. At the pharmacy, there are no requirements for audit trails or system security. Some pharmacy systems have good security practices, but others might not. Records could be created or altered without leaving a trace. The existing system, in short, relies on the hope that vendors will employ good security practices; a few vendors may meet these, but others for simplicity or for economic reasons may choose to ignore them. The widespread reliance on simple passwords stored on computers available to any staff member undermines any claim of reasonable security controls. The existing voluntary certification bodies may help, but for transmission they only look at whether the system can interoperate with them. There is, in any case, no requirement that practitioners or pharmacies use only certified vendors; given the high costs of some certified systems, it would be surprising if some practitioners did not elect less expensive, uncertified solutions. Overall, the existing system provides no legal requirements for identity proofing, assurance of nonrepudiation, ability to authenticate the record, and record integrity. It exposes DEA registrants to the threat of identity theft, insider criminal activity, service provider or intermediary staff criminal activity, and potential criminal penalties for the actions of others that they will find hard to disprove. It creates a new high-speed route for widespread prescription forgery and diversion, which results in drug abuse and deaths. The idea that DEA should wait until this occurs before attempting to impose security requirements cannot be reconciled with the agency's statutory responsibilities and the magnitude of the harm to the public health and safety that would result if an insufficiently secure system were to cause an increase in diversion of controlled substances. Such an idea also fails to properly take into consideration the length of time required to change regulations. For this alternative, the only way for the pharmacy, dispensing pharmacist, and DEA to ensure that the prescription a pharmacy received was, in fact, issued by the practitioner whose name and DEA registration number are on the prescription would be to require the pharmacy to call the practitioner and confirm each prescription. For DEA to allow a controlled substance prescription to be dispensed without this check would be to abdicate its statutorily mandated responsibilities. Although this alternative would impose the fewest burdens on service providers, it would be hugely expensive for practitioners and pharmacies, requiring up to 300 million callbacks a year. DEA has estimated the costs of this alternative, but DEA does not consider that the costs could be justified or that practitioners or pharmacies would adopt this alternative given the increased burden that it would represent. *Public Key Infrastructure.* DEA considered proposing that all electronic controlled substance prescriptions be digitally signed using a digital certificate issued by a recognized Certification Authority. Under this approach, the prescription as signed and the digital signature would be sent to the pharmacy, which would be required to validate the prescription to ensure that it had not been altered after signature. This alternative would provide DEA and other law enforcement agencies with the best forensic evidence, and it would provide practitioners and pharmacies with the best protection against identity theft and forgeries, reducing their legal exposure. However, DEA has been advised that existing systems which follow the standards adopted by the Secretary of HHS pursuant to the MMA for electronic transmission of prescriptions and prescription-related information for covered Part D drugs prescribed for Part D eligible individuals are incompatible with the requirement of digitally signed prescriptions. Electronic prescriptions are processed through intermediaries that may reformat the prescriptions to ensure that the receiving pharmacy can capture the data; the reformatting makes validation of the record impossible. In addition, the intermediaries have expressed concern about incorporating the digital signature, which is usually at least 128 bits, within the current SCRIPT standard. Consequently, DEA does not consider this option to be a viable mandatory approach. DEA considered and is proposing two options: *Electronically signed prescriptions with security controls.* Under this alternative, practitioners would be required to undergo in-person identity proofing and submit documentation of that to a service provider. The identity proofing would be conducted by a DEA-registered hospital, a State licensing board, or State or local law enforcement agency. The service provider would be required to check the validity of the DEA registration and State license before issuing an authentication protocol to be used to sign controlled substance prescriptions. The authentication protocol would have to be two-factor, with one factor stored on a hard token (e.g., a PDA, a multifactor one-time-use password token, a thumb drive, a smart card). DEA would also impose certain system requirements related to the prescription elements and their presentation; most existing systems may already meet these requirements. The prescription would have to be transmitted immediately upon being signed and the service provider would have to digitally sign and archive the record before transmitting the plain text prescription to the intermediaries. The pharmacy would have to digitally sign and archive the prescription as received. The pharmacy system would need an internal audit trail to record any attempts to alter a record and conduct internal checks for such attempts. Both the electronic prescription service provider and the pharmacy system provider would need to obtain annual third-party audits for security and processing integrity. The service provider would have to generate a monthly log, which practitioners would be required to check for obvious anomalies. The rationale for each of the requirements is presented under the discussion of the proposed rule below. *Modified digitally signed prescriptions.* Due to the current use of digital signatures by Federal health care systems, and the added security afforded by such signatures, DEA is proposing to allow practitioners that prescribe controlled substances at Federal health care facilities (e.g., Department of Veterans Affairs, Department of Defense) the additional option of using digital certificates, issued by such Federal agencies, to sign controlled substance prescriptions issued in the course of their official duties within those facilities. These Federal agencies would need to determine that the practitioner is authorized and registered, or exempted from the requirement of registration, to prescribe controlled substances. The private key would be required to be stored on a hard token. Federal agencies will already be meeting this requirement in issuing Personal Identification Verification

(PIV)cards under Federal Information Processing Standard 201. Most of the system requirements would be the same as in the previous option except that the Federal agency could elect to allow the practitioner to digitally sign and archive the prescription once the DEA-required elements are complete and transmit later when other information has been added (e.g., retail pharmacy URL). The Federal agency would not have to digitally sign the record as transmitted. The pharmacy requirements would be the same. The digital signature would not be transmitted to the pharmacy; the pharmacy would not have to validate the record. However, if a Federal agency wished to include the digital signature as part of the transmission, DEA is permitting this alternative. In that case, the pharmacy would be required to validate the digital signature, but would not be required to digitally sign the prescription as received. Because a Certification Authority would issue the digital certificate and because record integrity is more assured with a digital signature, DEA would not require a check of a monthly log or third-party audits for security. The rationale for each of the requirements is presented under the discussion of the proposed rule below. VII. Risk Assessment of Electronic Prescriptions for Controlled Substances On December 16, 2003, the Office of Management and Budget

(OMB)issued guidance to Federal agencies on e-authentication (M-04-04) that directed agencies to conduct e-authentication risk assessments to determine the level of authentication needed. It should be noted that M-04-04 was primarily intended to provide guidance to Federal agencies that utilize services through the Internet, not private sector entities that do so. However, M-04-04 states: “Private-sector organizations and state, local, and tribal governments whose electronic processes require varying levels of assurance may consider the use of these standards where appropriate.” With this understanding, the document provides a useful illustration of how to identify and analyze the risks associated with the authentication process. Assurance is the degree of confidence in the vetting process used to establish the identity of an individual to whom a credential was issued, the degree of confidence that the individual who uses the credential is the individual to whom the credential was issued, and the degree of confidence that a message when sent is secure. OMB established four levels of assurance: *Level 1:* Little or no confidence in the asserted identity's validity. *Level 2:* Some confidence in the asserted identity's validity. *Level 3:* High confidence in the asserted identity's validity. *Level 4:* Very high confidence in the asserted identity's validity. M-04-04 states that to determine the appropriate level of assurance in the user's asserted identity, agencies must assess the potential risks and identify measures to minimize their impact. The document states that the risk from an authentication error is a function of two factors:

(a)Potential harm or impact and

(b)the likelihood of such harm or impact. The document then specifies six categories of harm that might result from an authentication error: • Inconvenience, Distress, or Damage to Standing or Reputation • Financial Loss • Harm to Agency Programs or Public Interests • Unauthorized Release of Sensitive Information • Personal Safety • Civil or Criminal Violations With respect to each of these six categories, the agency must assess the potential impact as “low,” “moderate,” or “high.” Table 1 showsOMB's impact criteria for each category of harm. 13 13 Office of Management and Budget. “E-Authentication Guidance for Federal Agencies” M-04-04. December 16, 2003. Table 1.—M-04-04 Potential Impacts of Authentication Errors Low impact Moderate impact High impact Potential Impact of Inconvenience, Distress or Damage to Standing or Reputation At worst, limited short-term inconvenience, distress or embarrassment to any party At worst, serious short-term or limited long-term inconvenience or damage to the standing or reputation of any party Severe or serious long-term inconvenience, distress or damage to the standing or reputation to the party (ordinarily reserved for situations with particularly severe effects or which may affect many individuals). Potential Impact of Financial Loss At worst, an insignificant or inconsequential unrecoverable financial loss to any party, or at worst, an insignificant or inconsequential agency liability At worst, a serious unrecoverable financial loss to any party, or a serious agency liability Severe or catastrophic unrecoverable financial loss to any party; or severe or catastrophic agency liability. Potential impact of harm to agency programs or public interests At worst, a limited adverse effect on organizational operations, assets, or public interests. Examples of limited adverse effects are:

(i)mission capability degradation to the extent and duration that the organization is able to perform its primary functions with noticeably reduced effectiveness; or

(ii)minor damage to organizational assets or public interests Examples of serious adverse effects are:

(i)significant mission capability degradation to the extent and duration that the organization is able to perform its primary functions with significantly reduced effectiveness; or

(ii)significant damage to organizational assets or public interests A severe or catastrophic adverse effect on organizational operations or assets, or public interests. Examples of severe or catastrophic effects are:

(i)severe mission capability degradation or loss of [sic] to the extent and duration that the organization is unable to perform one or more of its primary functions; or

(ii)major damage to organizational assets or public interests. Potential Impact of unauthorized release of sensitive information At worst, a limited release of personal, U.S. government sensitive, or commercially sensitive information to unauthorized parties resulting in a loss of confidentiality with a low impact, as defined in FIPS PUB 199 At worst, a release of personal, U.S. government sensitive, or commercially sensitive information to unauthorized parties resulting in a loss of confidentiality with a moderate impact, as defined in FIPS PUB 199 At worst, a release of personal, U.S. government sensitive, or commercially sensitive information to unauthorized parties resulting in a loss of confidentiality with a high impact, as defined in FIPS PUB 199. Potential Impact to Personal Safety At worst, minor injury not requiring medical treatment At worst, moderate risk of minor injury or limited risk of injury requiring medical treatment A risk of serious injury or death. Potential impact of civil or criminal violations At worst, a risk of civil or criminal violations of a nature that would not ordinarily be subject to enforcement efforts At worst, a risk of civil or criminal violations that may be subject to enforcement efforts A risk of civil or criminal violations that are of special importance to enforcement programs. The Memorandum then states: Agencies should then tie the potential impact category outcomes to the authentication level, choosing the lowest level of authentication that will cover all of potential impacts identified. Thus, if five categories of potential impact are appropriate for Level 1, and one category of potential impact is appropriate for Level 2, the transaction would require a Level 2 authentication. For example, if the misuse of a user's electronic identity/credentials during a medical procedure presents a risk of serious injury or death, map to the risk profile identified under Level 4, even if other consequences are minimal. Again, with the understanding that M-04-04 was not specifically designed to be used by Federal agencies when issuing regulations governing the general public, the logic and method of analysis employed by M-04-04 nonetheless serves as a useful model for completing DEA's task of determining the appropriate level of authentication for electronic prescribing of controlled substances. (In fact, DEA is unaware of any other Government documents that provide any such particularized guidance for completing this task.) For the proposed rule, the two aspects that are relevant to the e-authentication risk assessment are the identity-proofing and the storage of the authentication protocol or digital certificate. The following table presents the six categories of harm and impact using the three OMB-defined potential impact values to determine an identity authentication assurance level for the electronic prescribing of controlled substances (see Attachment A of the memorandum, “E-Authentication Guidance for Federal Agencies”). Table 2.—Impact of Harms of Electronic Prescriptions for Controlled Substances Potential impact of authentication errors DEA rating, OMB description Comment Inconvenience, Distress, or Damage to Standing or Reputation Moderate—At worst, serious short term or limited long-term inconvenience, distress, or damage to the standing or reputation of any party Identity theft, issuing of illegitimate prescriptions in a practitioner's name, or alteration of prescriptions could expose practitioners to legal difficulties and force them to prove that they had not enrolled in an electronic prescription system or issued specific prescriptions. Financial Loss N/A Harm to Agency Programs or Public Interests High—A severe or catastrophic adverse effect on organizational operations or assets, or public interests. Examples of severe or catastrophic effects are:

(i)Severe mission capability degradation or loss of

(sic)to the extent and duration that the organization is unable to perform one or more of its primary functions; or

(ii)major damage to organizational assets or public interests Not to place such strict requirements on authentication protocols used to sign electronic controlled substances prescriptions would open the electronic prescribing system for controlled substances to rampant diversion—diversion which would be very difficult for DEA to detect because of the breadth of the potential problem. Were the authentication protocol of a practitioner compromised, and were controlled substances prescriptions to be diverted for illicit purposes based on that compromised authentication protocol, such diversion would undermine the effectiveness of prescription laws and regulations of the United States. This diversion would, by its very nature, harm the public health and safety, as any illicit drug use does. Such diversion would undermine the effectiveness of the entire closed system of distribution of the United States created by the CSA and supported by international treaty obligations. Unauthorized release of Sensitive Information N/A Personal Safety High—A risk of serious injury or death Congress expressly declared in enacting the CSA that the “improper use of controlled substances [has] a substantial and detrimental effect on the health and general welfare of the American people.” (21 U.S.C. 801(2)). Diversion and abuse of controlled substances results in a large number of deaths and medical visits each year; facilitating diversion can be expected to increase the level of abuse and harm. Civil or Criminal Violations High—A risk of civil or criminal violations that are of special importance to enforcement programs Given the framework of the CSA and DEA's core mission to enforce the Act, there is perhaps nothing of greater importance among DEA's administrative responsibilities than ensuring that controlled substances are dispensed only by registered practitioners. The illicit possession of legitimate (pharmaceutical) controlled substances is a violation of the CSA. The writing of a controlled substance prescription by a person not authorized to do so constitutes illegal distribution of controlled substances and is a violation under 21 U.S.C. 841(a)(1). The person writing an illegitimate prescription could be criminally prosecuted; penalties for such a conviction could include imprisonment and/or fines. Because of the number of persons having access to an electronic prescription between the time it is written and the time it is dispensed, including the practitioner's office staff, intermediaries who process the prescription, and the pharmacy staff, the potential for alteration is great. A practitioner whose prescriptions were altered by someone else—office staff or staff at one of the intermediaries—could be subject to legal action in which the practitioner would have to prove that he was not responsible for the prescriptions to avoid civil or criminal liability. If a pharmacy knowingly dispenses a forged or altered prescription, such dispensing constitutes illegal distribution and is a violation of the CSA. The pharmacy could be subject to administrative, civil, or criminal action under the CSA. A criminal conviction for unlawful dispensing in violation of the CSA is a felony that could, depending on the schedule of the controlled substance involved, and the harm resulting, result in a sentence of a lengthy period of incarceration and substantial fine. Even without a criminal conviction, civil violations of the CSA can result in substantial fines. Criminal or civil violations of the CSA might also result in revocation of the pharmacy's registration to dispense controlled substances. DEA welcomes comments regarding its assessment of risk for the six categories of harm for the electronic prescribing of controlled substances. Commenters should frame their comments in the context of the impacts of those categories of harm included in OMB M-04-04 and Table 1 above. OMB provides the following guidance in M-04-04 on applying the risk assessment to assurance levels. Table 3.—Maximum Potential Impacts for Each Assurance Level Level 1 Level 2 Level 3 Level 4 Potential Impact of Inconvenience, Distress, or Damage to Standing or Reputation Low Impact Moderate Impact Moderate Impact High Impact. Potential Impact of Financial Loss Low Impact Moderate Impact Moderate Impact High Impact. Potential impact of harm to agency programs or public interests n/a Low Impact Moderate Impact High Impact. Potential Impact of unauthorized release of sensitive information n/a Low Impact Moderate Impact High Impact. Potential Impact to Personal Safety n/a n/a Low Impact Moderate Impact. Potential impact of civil or criminal violations n/a Low Impact Moderate Impact High Impact. The table below shows the potential impact as rated by DEA and the assurance level associated with each. Table 4.—Potential Impact and Associated Assurance Levels for Electronic Prescriptions for Controlled Substances Potential impact—DEA rating Level of assurance Inconvenience, Distress, or Damage to Standing or Reputation—Moderate Level 2. Financial Loss—N/A N/A. Harm to Agency Programs or Public Interests—High Level 4. Unauthorized release of Sensitive Information—N/A Level 1. Personal Safety—High Level 4. Civil or Criminal Violations—High Level 4. If any one or more of the potential impact categories for authentication errors is found to be high, M-04-04 directs agencies that the appropriate assurance level must be “Level 4” (the highest level). Indeed, DEA notes that M-04-04 specifically lists the following as an example of a situation for which Level 4 is appropriate: A Department of Veteran's Affairs pharmacist dispenses a controlled drug. She would need full assurance that a qualified doctor prescribed it. She is criminally liable for any failure to validate the prescription and dispense the correct drug in the prescribed amount. 14 14 Although OMB M-04-04 describes a Department of Veterans Affairs pharmacist needing “full assurance that a *qualified doctor* prescribed [the controlled substance]” [emphasis added], DEA recognizes that in addition to physicians, the Department of Veterans Affairs also employs dentists and certain mid-level practitioners who are authorized to prescribe controlled substances. The explanation provided in the above example is no less applicable where the pharmacist is employed by the private sector. Even if such risk is essentially identical for both VA pharmacies and private sector pharmacies, the reasoning of M-04-04 indicates that Level 4 assurance is appropriate in both scenarios. NIST Special Publication

(SP)800-63, Electronic Authentication Guideline, provides guidance on applying the OMB assurance levels to identity proofing and authentication. Identity proofing is the process of determining whether the person being granted authorization to use a system is, in fact, the person he claims to be. Authentication refers to the method by which the person is then granted access to a computer system (e.g., PINs, passwords, biometrics). NIST SP 800-63 defines the steps needed to conduct identity proofing and establish authentication protocols for each OMB assurance level. DEA has used NIST SP 800-63 as a guideline in developing its proposed requirements. *Assurance Levels—Identity Proofing.* Identity proofing is the process of uniquely identifying a person. NIST SP 800-63 specifies a number of requirements for both remote and in-person identity proofing for each assurance level. DEA believes that in-person identity proofing is critical to the security of the electronic prescribing of controlled substances. Ensuring that only licensed and registered practitioners are granted the authority to sign electronic prescriptions for controlled substances is the first step to maintaining the overall security of the electronic prescribing system for these substances. At present, some service providers appear to allow enrollment over the Internet and only require the applicant to submit a copy of the State license and DEA registration. This type of enrollment increases the potential for identity theft and the creation of fraudulent identities of prescribing practitioners and, subsequently, the potential for issuance of forged prescriptions. DEA welcomes comment regarding the enrollment processes service providers have developed to adequately determine whether the people enrolling in such services are legally permitted to issue noncontrolled substance prescriptions and whether and how such processes prevent noncontrolled substance prescription forgery, fraud, and other related crimes. In-person identity proofing protects individual prescribing practitioners from identity theft. That is, without in-person identity proofing, it would be very easy for anyone to claim to be an individual prescribing practitioner and gain access to electronic prescribing systems for controlled substances; the most likely documents used to demonstrate identity as a prescribing practitioner—State license and DEA registration—can be easily obtained. Persons who work with prescribing practitioners have ready access to State licenses and DEA registration certificates as those documents are often stored at the prescriber's practice location. A member of the office staff could alter a practitioner's registration certificate or merely submit a copy of a practitioner's State license and DEA registration and begin issuing illegal prescriptions without the practitioner's knowledge. As information regarding State licensure and DEA registration is publicly available, people outside the office could create fraudulent DEA registration certificates and State licenses using legitimate numbers and gain access to the system. Unlike written prescriptions, once a fraudulent identity has been established, electronic prescribing provides little or no indication of the potential for fraud. With written prescriptions, if a person not knowledgeable of prescription-writing styles and tendencies writes or alters prescriptions, those prescriptions are likely to be noticed by a pharmacist who may scrutinize them further. In fact, if the prescription seems out of the ordinary in any way, e.g., the format is unusual, the paper is different from normal, the signature looks wrong, the directions are not in the usual format, the drug name is misspelled, the abbreviations used are not standard, or the quantity seems high, the pharmacy has a responsibility to contact the prescribing practitioner to verify the prescription before filling the prescription. With electronic prescribing, however, once an identity is established, all electronic prescriptions appear the same. Most information is selected from drop-down menus, and there is little to distinguish an electronic prescription written by a person who is not a legitimate prescribing practitioner from one that is written by an individual granted proper State and DEA authority to prescribe controlled substances. Based on DEA's decision that in-person identity proofing is critical to the overall security of the electronic prescribing system, DEA examined NIST requirements for in-person identity proofing. Briefly, at Level 2, in-person identity proofing requires the applicant to possess a government-issued photographic identification that confirms the address of record or nationality. Level 2 requires inspection of the photographic identification, and the recording of the applicant's address or date of birth and the number associated with the government-issued photographic identification. If the identification confirms the address of record then credentials are issued and notice is sent to that address; if the address is not confirmed, then credentials are issued in a manner that confirms the address of record. At Level 3, in-person identity proofing requires the applicant to possess a government-issued photographic identification. Level 3 requires inspection of the photographic identification and verification, through the issuing government agency or through credit bureaus or similar databases, that the information contained in the identification (e.g., name, address, date of birth) are consistent with the application. The applicant's name, address, and date of birth are recorded. If the identification confirms the address of record then credentials are issued and notice is sent to that address; if the address is not confirmed, then credentials are issued in a manner that confirms the address of record. At Level 4, two independent forms of photographic identification or accounts must be verified, one of which must be a government-issued photographic identification. Further, a new recording of a biometric of the applicant must be captured. The government-issued photographic identification must be verified with the issuing government agency. For any form of photographic identification, the applicant's name, address, and date of birth are recorded. If the secondary form of identification is a financial account, the financial account number must be verified through record checks sufficient to identify a unique individual. The biometric is recorded to ensure that the applicant cannot repudiate the application. Credentials must be issued in a manner that confirms the address of record. After careful examination of all levels of in-person identity proofing, DEA determined that none of the NIST levels addressed its unique needs and requirements. DEA does not believe that capturing a biometric at the time of enrollment is necessary, as is required at Level 4. Further, DEA does not believe that verification of identity through use of credit bureaus or other third-party agencies would be feasible or is necessary, as is required at Level 3, given that practitioner's State licenses and DEA registrations are also being examined. DEA believed that such requirements could be intrusive for practitioners, who might not want hospitals, State licensing boards, or law enforcement agencies—the entities DEA is proposing to permit conduct in-person identity proofing—to review sensitive personal information such as address information retained by credit bureaus. Finally, DEA did not believe that the address checks required at Level 2 were useful for the purpose served by the in-person identity proofing DEA believes it must require. DEA notes that address checks generally mean address of residence, because that is the address listed on most forms of government-issued photographic identification, whereas prescribing practitioners will receive information and authentication protocols at their offices, which are the addresses listed on the DEA registration and State licenses. Therefore, DEA has decided to propose in-person identity proofing consistent with, but not equivalent to, Level 3, as discussed below, but not link that in-person identity proofing to any specific NIST requirements. DEA could not identify any mitigating factors that would enable it to propose remote identity proofing. Remote identity proofing relies on record checks, which would not prevent identity theft and may be more intrusive than the simple in-person requirements DEA is proposing. Remote identity proofing also relies on mailing credentials to the address of record, which would not prevent a member of the office staff from applying for access to the electronic prescribing system for controlled substances and intercepting the confirmation. The electronic world allows for far easier identity theft and can make it more difficult to identify diversion when it occurs. In contrast, when DEA or the States have discovered identity theft in the context of paper prescriptions, they have been able to prosecute the criminal using the paper trail created by fraudulent prescriptions. The paper prescriptions can prove who wrote them and, for the innocent practitioner, who did not write them. With electronic prescriptions, identities can be stolen, used to issue a large number of prescriptions, then dropped within days, leaving few if any traces, or worse, traces that link to a practitioner who then would have to prove that he or she was an innocent victim, not a criminal. DEA is proposing to allow DEA-registered hospitals, State licensing boards, and State or local law enforcement agencies to review the identity documents and sign, with the applicant, a letter or form that states that the applicant is who the applicant claims to be. This approach should lessen the burden on service providers and ensure that practitioners will be able to have their documents checked locally. *Assurance Level—Authentication Protocol.* NIST SP 800-63 defines tokens as the means that a person wishing to gain access to an electronic system uses to authenticate their identity. In electronic authentication, the person wishing to gain access authenticates to a system or application over a network by proving that he has possession of a token. Therefore, a token must be protected. Authentication methods are described as one-factor, two-factor, or three-factor, or as something you know, something you have, and something you are. PINs and passwords are something you know; cards such as ATM cards are something you have; biometrics (fingerprints, iris scans, hand prints) are something you are. NIST SP 800-63 describes a single-factor token as either something the person knows, something the person has, or a biometric. Single-factor tokens include: • Memorized secret tokens (passwords, passphrases). • Pre-registered knowledge tokens: responses to a question known by the user (pet's name, favorite color). • Look-up secret tokens—the user is prompted by the system to look up information stored on a physical or electronic device (the secret may be printed on a card or stored in the computer); the information looked up has been shared between the user and the system being authenticated to. • Out of band tokens—Receipt of a secret on a physical device separate from the system being authenticated to which is then used to log onto the system (e.g., a password is sent to a cell phone; the person who possesses the cell phone uses the password to log onto the system). • Single factor one time password

(OTP)device—a hardware device that spontaneously generates one time passwords, which usually change every 60 seconds. The one time passwords are used to log onto the system. • Single factor cryptographic device—a hardware device that uses embedded cryptographic keys; authentication occurs by proving possession of the device. NIST discussed the vulnerability of single-factor authentication methods, specifically passwords, in Special Publication 800-32: The traditional method for authenticating users has been to provide them with a personal identification number or secret password, which they must use when requesting access to a particular system. Password systems can be effective if managed properly, but they seldom are. Authentication that relies solely on passwords has often failed to provide adequate protection for computer systems for a number of reasons. If users are allowed to make up their own passwords, they tend to choose ones that are easy to remember and therefore easy to guess. If passwords are generated from a random combination of characters, users often write them down because they are difficult to remember. Where password-only authentication is not adequate for an application, it is often used in combination with other security mechanisms. PINs and passwords do not provide non-repudiation, confidentiality, or integrity. If Alice wishes to authenticate to Bob using a password, Bob must also know it. Since both Alice and Bob know the password, it is difficult to prove which of them performed a particular operation. 15 15 National Institute of Standards and Technology. Special Publication 800-32 *Introduction to Public Key Technology and the Federal PKI Infrastructure; February 26, 2001. http://csrc.nist.gov/* Pre-registered knowledge tokens usually have answers that may be known by other people in an office. Look-up secrets are as vulnerable as passwords in a medical practice settings. Out-of-band tokens would take more time to use. Single factor hard tokens could be borrowed or stolen and used easily. No single factor approach, therefore, would provide the assurance DEA and the practitioners need. NIST SP 800-63 describes two-factor tokens as tokens that use two or more factors to achieve authentication. Multi-factor tokens include: • Multi-factor software cryptographic tokens—a cryptographic key is stored on a computer and requires activation through a second factor of authentication. • Multi-factor one time password device—a software device, (e.g., PDAs) or a hardware device (e.g., a card, thumb drive, fob), that generates one time passwords for use in authentication and requires activation through a second factor of authentication, usually a password. • Multi-factor cryptographic hardware device—hardware device that contains a protected cryptographic key and requires activation through a second authentication factor. As NIST points out, the use of more than one factor for authentication to a system raises the difficulty of an attacker successfully attacking a system. The more factors used, the more effort it takes to break the system to gain entry. Briefly, at Level 2, single-factor authentication is allowed. Some combinations of single-factor authentication are still considered Level 2 (e.g., passwords plus pre-registered knowledge tokens are still rated as Level 2). At Level 3, some combinations of single-factor tokens are acceptable (e.g., a password plus a single-factor one time password device). In addition, a multi-factor software cryptographic device is considered Level 3; this device allows for the storage of the cryptographic key on a disk (e.g., a hard drive of a personal computer). At Level 4, only two types of tokens are acceptable—a multi-factor one time password device or a multi-factor cryptographic device that is stored on a hard token (e.g., a smart card, a thumb drive). DEA is proposing that the authentication protocol meet Level 4, which requires two factors, one of which is stored on a hard token, which could be a PDA, a cell phone, a smart card, a thumb drive, or multi-factor one time password token. DEA has determined that only Level 4 meets its requirements based on the risk assessment and on the problems that arise with Level 3, where one of the factors can be stored on a computer rather than a hardware device that the practitioner can possess, or Level 2, where only a single factor is required. NIST describes Level 4 tokens as follows: “To achieve Level 4 with a single token or token combination, one of the tokens needs to be usable with an authentication mechanism that strongly resists man-in-the-middle attacks—this entails an electronic interface which may be placed under access control by the Claimant's (the person seeking to gain access to the system) operating system.” 16 17 DEA would like public comment on the present state of multi-factor tokens as implemented through multi-function devices such as PDAs, cell phones, smart cards, thumb drives and laptop computers. 16 National Institute of Standards and Technology. Special Publication 800-63-1 *Electronic Authentication Guideline* draft; February 20, 2008. p. 52. 17 DEA notes that in the course of drafting this rulemaking, the National Institute of Standards and Technology issued a new draft Special Publication 800-63, which revises some guidelines regarding electronic authentication. DEA has taken these new guidelines into account in drafting this Notice of Proposed Rulemaking recognizing, however, that this Special Publication is a draft and subject to revision by NIST when the final SP 800-63-1 is issued. As DEA is not proposing specific controls regarding the authentication process or the transmission of the prescription information, DEA believes that the security of the authentication itself is critical to bind the practitioner to the prescribing transaction. Level 4 authentication protocols protect the practitioner from the most likely “attack,” the use of his password or other token to access the system and issue prescriptions. Because Level 3 allows the storage of authentication protocols on office computers, the practitioner has no assurance that his authentication protocol will be safe or that he will be aware if it is compromised. From a law enforcement perspective, an authentication protocol stored on a computer to which others have access makes linking a prescription to a practitioner or to a staff member who has illegally issued prescriptions all but impossible. Level 4, where the practitioner can retain possession of the hard token, protects the practitioner and provides law enforcement with the necessary nonrepudiation. Because of the attributes of medical practices, DEA could identify no mitigating factors that could overcome the vulnerabilities that exist and allow a lower level of assurance. In medical practices, most staff members have access to any of the computers in the office. Practitioners and nurses see patients in multiple examination rooms, moving from room to room; of necessity, practitioners must leave their offices and computers unattended for long periods of time. Passwords, which are usually part of two-factor authentication protocols to access the system, are vulnerable to attack because

(1)many people write them down;

(2)most people choose passwords that are easy to guess; and

(3)in medical settings, with multiple people working in the vicinity of a computer, it is easy for someone else to watch a password being keyed into the system. If both parts of a multi-factor identification protocol can be stored on an office computer, or if there is only one factor needed (Level 2), the practitioner will have no assurance that someone in the office is not issuing prescriptions in his name. The practitioner will also be able to repudiate any prescription written in his name; law enforcement officials will not be able to prove beyond a reasonable doubt in a criminal proceeding that his authentication protocol had not been compromised. Storing one of the factors on a hard token means that the practitioner can retain possession of the device and ensures that it is not misused. The practitioner will not be able to repudiate prescriptions issued in his name; the practitioner will either have written the prescription, knowingly given the hard token to someone else, or, if the token was lost, stolen, or compromised, have taken appropriate actions (such as ensuring that the authentication protocol has been revoked to prevent its misuse). The hard token protects the practitioner in the same way a manually signed written prescription does. If a written prescription is forged, a practitioner can prove that he did not write it by comparing handwriting. By maintaining sole possession of the hard token, the practitioner can eliminate the risk of fraudulent prescriptions and, if the token is lost, stolen, or compromised, he will be immediately alerted to the threat and have the authentication protocol revoked. This assurance that only a legitimate practitioner issued the prescription also protects the pharmacy. As discussed above, with a paper prescription there are potentially many indications that the prescription was not written by a practitioner. If the prescription seems out of the ordinary in any way the pharmacy has a responsibility to verify the prescription before filling the prescription. With electronic prescriptions, it will be much more difficult to identify these potentially telltale characteristics because the software fills in items from a menu of acceptable options; unless the quantity is high, the pharmacist will have little reason to question an electronic prescription. The requirement for two-factor authentication (something you know and something you have) has been implemented by a number of healthcare systems. One system with almost 300 hospitals and clinics is using a combination of PINs (something you know) and a one-time-password token or software tokens

(PDAs)for almost 30,000 users. Another medical center uses the same approach for more than 4,500 users. A third health care system with a variety of treatment centers has deployed this approach to 8,000 people at more than 40 sites. These deployments indicate that the requirement is feasible in healthcare settings and that it is flexible enough to provide access and access control as practitioners move among settings in which they practice. Although the electronic prescribing of controlled substances plainly fits in the categories of transactions for which Level 4 assurance is warranted, DEA has decided, following interagency discussions, not to propose all of the authentication requirements that NIST SP 800-63 indicates are appropriate for Level 4. Among other things, as explained below, DEA is not proposing that practitioners digitally sign prescriptions or that pharmacies routinely validate prescriptions that are digitally signed because doing so would be incompatible with many existing systems currently in use for the electronic prescribing of noncontrolled substances. Nonetheless, DEA is proposing here an alternative authentication system that comes as close as reasonably possible to the level of security called for in NIST SP 800-63 while remaining compatible with existing systems used for noncontrolled substance prescriptions and, at the same time, adhering to DEA's overarching obligation to minimize the likelihood of diversion of controlled substances. *Assurance Level—Authentication Process.* The authentication process addresses security between the creator of a message and its recipient. At Level 4, the authentication process involves strong cryptographic authentication of all parties and all sensitive data transfers. A variety of technologies can meet Level 2 and 3; the levels are defined by their resistance to certain forms of attack. Level 2 can be met with an encrypted TLS protocol session. Level 3 can be met with authenticated TLS and public key certificates. DEA is not proposing to set any standards for the authentication process. The NIST requirements apply primarily to the transmission of information. DEA is concerned about the possibility that an electronic prescription could be altered during transmission, but the agency is not proposing specific regulations in this area at this time. DEA is proposing to address the vulnerabilities that exist by having the prescription digitally signed by the service provider prior to transmission and on receipt at the pharmacy. These requirements will not prevent alteration during transmission, but they will allow DEA to identify that it has occurred and protects registrants from being accused of issuing a fraudulent prescription or altering a legitimate prescription. DEA also notes that the security of these records during transmission is subject to HIPAA. *Summary.* In conclusion, although the risk of electronic prescribing of controlled substances maps to Assurance Level 4 using the criteria of M-04-04, DEA is not proposing all of the requirements associated with that level. Instead, DEA is proposing in-person identity proofing specific to its needs; these requirements are consistent with, but not equivalent to, Level 3, and address concerns specific to DEA. Further, DEA is proposing use of a hard token, with that hard token meeting the requirements of Level 4. Finally, DEA is not proposing any requirements regarding the authentication process and transmission of the electronic prescriptions. The table below provides a summary of DEA's conclusions regarding its risk assessment of systems to permit the electronic prescribing of controlled substances. Table 5.—Summary of Risk Assessment for Electronic Prescriptions for Controlled Substances M-04-04 Assurance Level Level 4—High potential impact of harm to agency programs or public interests, personal safety, civil or criminal violations. NIST identity proofing In-person identity proofing requirements specific to DEA; requirements consistent with, but not equivalent to, NIST Level 3 in-person identity proofing. NIST authentication protocol Level 4—Use of hard token or multifactor one-time-use password token is necessary to bind the prescriber to the prescription. NIST authentication process N/A—DEA is not proposing any requirements in this area. As has been discussed, DEA is proposing in-person identity proofing requirements consistent with, but not equivalent to, Level 3; authentication protocol requirements, use of a hard token and two-factor authentication, meeting the requirements of Level 4; and no requirements regarding the authentication process. DEA welcomes comments and information regarding alternative solutions for the electronic prescribing of controlled substances employing security controls that are as effective as those being proposed in this Notice of Proposed Rulemaking and also would meet DEA statutory and regulatory obligations under the Controlled Substances Act. Information provided should be as specific and detailed as possible to provide the Administration with an understanding of how the commenter believes the alternative solution could be implemented to satisfy the foregoing considerations. Any person providing such comments should discuss the specific risks being addressed and how any such risk-mitigating controls are incorporated into the alternative being discussed, and should state why the commenter believes such controls are adequate to address DEA's concerns. Any person providing such comments should also discuss the system vulnerabilities, risks, and weaknesses of any alternatives provided. If a commenter believes that any proposed requirement is either too stringent or too lax, the commenter should so state, providing a detailed explanation of how the controls mitigate the identified risks, or how the lack of controls aggravate or fail to address the risks involved in the electronic prescribing of controlled substances and, thus, why the commenter's alternative warrants consideration as an alternative to the requirement being proposed. Hence all comments should clearly identify how all risk-mitigating compensating controls adequately address each security concern outlined in the proposed rule. For example, DEA welcomes comments on the following topics: • Whether in-person identity proofing requirements consistent with, but not equivalent to, Level 3, are sufficient to address DEA's concerns, or whether

(a)more stringent requirements, such as those required under Level 4, are necessary, or

(b)DEA's concerns could be addressed with Level 2 requirements combined with risk-mitigating controls. • Whether authentication protocol requirements, use of a hard token and two-factor authentication, meeting the requirements of Level 4 are sufficient to address DEA's concerns, or whether

(a)more stringent requirements, such as those imposed in a public key infrastructure system, are necessary, or

(b)DEA's concerns could be addressed with Level 3 requirements combined with risk-mitigating controls. • Whether no requirements regarding the authentication process, as proposed in this rule, should cause DEA concern, such that imposing requirements is necessary. VIII. Proposed Standards for Electronic Prescription Systems for Controlled Substances The following discussion relates to requirements DEA is proposing regarding the creation, signature, transmission, processing and dispensing of controlled substance prescriptions. As discussed below, practitioners and pharmacies—DEA registrants—must use systems and service providers which comply with all requirements DEA may finalize. While these requirements pertain specifically to prescriptions for controlled substances, nothing in this rule precludes practitioners, pharmacies, or service providers from using these same standards for prescriptions for noncontrolled substances, if they so desire. However, DEA notes that any references throughout the following discussion relate solely to prescriptions for controlled substances. In this rule, DEA is proposing various security requirements for systems and service providers that market software and services to practitioners and pharmacies to create, sign, transmit, process and dispense electronic controlled substance prescriptions. It is incumbent upon DEA registrants—practitioners and pharmacies—the entities regulated by DEA, to use systems and service providers that comply with DEA security requirements for the electronic prescribing and dispensing of controlled substances. DEA recognizes that its registrants may not be able to evaluate a service provider's compliance and so is establishing third-party audit and other requirements to assist registrants in determining whether a system or service provider they currently use, or are considering using, meets DEA security requirements. While this preamble and rule require actions of service providers, it is the DEA-registered practitioner or pharmacy DEA will look to if the system or service provider that practitioner is using is not in compliance with DEA regulations. It is, ultimately, the DEA-registered individual practitioner and pharmacy who are responsible for the prescribing and dispensing of any controlled substance prescription, and the requirements of this rule do not change that longstanding responsibility and liability. DEA is proposing the following requirements for the use of electronic systems to create, sign, dispense, and archive controlled substance prescriptions, which are discussed in detail below: • The electronic prescription service provider must receive a document prepared by an entity permitted to conduct in-person identity proofing of prescribing practitioners regarding the conduct of the in-person identity proofing. The document may be prepared on the identity proofing entity's letterhead or other official form of correspondence, or the service provider may design a form for use by the identity proofing entity. Regardless of the format, the document must contain certain information required by DEA. Entities DEA is proposing to permit conduct in-person identity proofing of prescribing practitioners include: ○ The entity within a DEA-registered hospital that has previously granted the practitioner privileges at the hospital (e.g., a hospital credentialing office); ○ The State professional or licensing board, or State controlled substances authority, that has authorized the practitioner to prescribe controlled substances; ○ A State or local law enforcement agency. ○ The service provider must check both the practitioner's State license and DEA registration to determine that both are current and in good standing. • Authentication: Access to the electronic prescribing system for the purposes of signing prescriptions must meet the standards for Level 4 authentication in NIST SP 800-63. That is, the system must require at least two-factor authentication to access the system; one factor must be a cryptographic key stored on a hard token that meets the requirements for Level 4 authentication in NIST SP 800-63 or a multi-factor one time password token. The hard token must be a hardware device that meets the following criteria: ○ The token must require entry of a password or biometric to activate the authentication key. ○ The token is not able to export the authentication key. ○ The token must be validated under Federal Information Processing Standard

(FIPS)140-2 as follows: ▪ Overall validation at Level 2 or higher. ▪ Physical security at Level 3 or higher. • The security of the system must be audited annually using a third-party audit that meets the requirements of a SysTrust or WebTrust audit for security and processing integrity. • The system must limit signing authority to those practitioners that have a legal right to sign prescriptions for controlled substances (i.e., the system must set varying levels of access to the system based on responsibilities). • The system must have an automatic lock out if the system is unused for more than 2 minutes. • The prescription must contain all of the required data (date of issuance of the prescription; patient name and address; registrant full name, address, DEA registration number; drug name, dosage form, quantity prescribed, and directions for use; and any other information specific to certain controlled substances prescriptions mandated by law or DEA regulations). Prior to signing the controlled substance prescription, the system must show the prescribing practitioner at least the patient name and address, drug name, dosage unit and strength, quantity, directions for use, and the DEA number of the prescriber whose identity is being used to sign the prescription. • Where more than one prescription has been prepared for signing, prior to authenticating to the system the practitioner must positively indicate which prescription(s) are to be signed. • The practitioner must authenticate himself to the system immediately before signing a prescription. • After authenticating to the system but prior to transmitting the prescription, the system must present the practitioner with a statement indicating that the practitioner understands that he is signing the prescription being transmitted. If the practitioner does not so indicate, by performing the signature function, the prescription cannot be transmitted. • The system must transmit the electronic prescription immediately upon signature. The system must not transmit a controlled substance prescription unless it is signed by a practitioner authorized to sign such prescriptions. • The electronic data file must include an indication that the prescription was signed. • The system must not allow printing of prescriptions that have been transmitted; if a prescription is printed, it must not be transmitted. • The system must generate a monthly log of controlled substance prescriptions and transmit it to the practitioner for his review. The practitioner must indicate that the log was reviewed. A record of that indication must be maintained for five years. • The first recipient of the prescription must digitally sign the prescription and archive the digitally signed version of the prescription as received. • The first pharmacy system that receives the prescription must digitally sign and archive a copy of the prescription as received. Alternatively, the intermediary that transmits the prescription to the pharmacy may digitally sign the transmitted prescription and transmit both the record and the digitally signed copy for the pharmacy to archive. • The digital signatures must meet the requirements of FIPS 180-2 and 186-2. • The pharmacy system must check to determine whether the DEA registration of the prescribing practitioner is valid. (Alternatively, any of the intermediary systems may conduct this check provided that the record indicates that the check has been conducted. The CSA database may be cached for one week from the date of issuance by DEA of the most current database.) • The pharmacy system must be able to store the complete DEA number including extensions. • The pharmacy system must have an audit trail that identifies each person who annotates or alters the record. The pharmacy system must conduct daily internal audits to identify any auditable events. • The system must have a backup system of records stored at a separate location. • The pharmacy system must have a third-party audit that meets the requirements of SysTrust or SAS 70 audits for security and processing integrity. • The contents of a controlled substance prescription must not be altered, other than by reformatting, during transmission. • A prescription created electronically for a controlled substance must remain in its electronic form throughout the transmission process to the pharmacy; electronic prescriptions may not be converted to other transmission methods, e.g., facsimile, at any time during transmission. DEA would like the public to comment on the ability of those members of industry currently providing electronic prescribing systems for noncontrolled substances to meet the requirements set forth in this proposed rule, and whether there might be entrepreneurs not currently providing electronic prescribing systems who would be willing and able to develop innovative systems that would meet the requirements proposed here. Other Requirements In addition to the system requirements, DEA is proposing to require the following: • A registrant must have separate password/keys for each DEA registration he holds and uses to issue prescriptions. Multiple keys may be stored on the same hard token. • The registrant must use the appropriate DEA registration for prescriptions issued. Practitioners holding multiple registrations in a single State may use just one for any prescription written in that State. • The registrant must retain sole possession of the hard token. If a token is lost or compromised and the registrant fails to notify the service provider within 12 hours of discovery, the registrant will be held responsible for any prescriptions written using the token. • The pharmacy must annotate the record with the same information required for a paper prescription. • The practitioner and pharmacist must notify DEA and the service provider if they identify problems in the logs they review that indicate that prescriptions have been created without their knowledge or altered. Discussion of the Proposed Rule System Requirements As noted previously, electronic prescribing is in addition to existing prescribing methods for controlled substances. DEA's goal is to impose as few new requirements on electronic prescription systems as possible while retaining the ability to enforce the Controlled Substances Act and its implementing regulations. Many of the requirements listed above exist in at least some systems currently in use. The Certification Commission for Health Information Technology EHR certification standards for security cover many of the access and authentication requirements DEA is proposing here. DEA believes that the proposed requirements will protect both practitioners and pharmacies by ensuring that they can meet their legal obligations and lessen the threat of someone misusing their authorities to divert controlled substances. DEA emphasizes that its electronic prescription requirements do not alter the responsibilities of the practitioner and pharmacy in regard to controlled substance prescriptions. Both the prescribing practitioner and the dispensing pharmacy have a legal responsibility to ensure that only prescriptions issued for legitimate medical purposes by DEA registrants acting in the usual course of their professional practice are dispensed. A practitioner who knowingly allows someone to issue prescriptions in the practitioner's name is legally responsible for those prescriptions. A pharmacy that fails to check the validity of a controlled substance prescription before dispensing is legally responsible if the prescription is invalid. *In-person identity proofing.* DEA considered requiring service providers to conduct in-person identity proofing of prescribing practitioners as part of their enrollment process. However, after careful consideration, DEA determined that in-person identity proofing by service providers created certain vulnerabilities which could not be overcome. Specifically, DEA was concerned that by requiring service providers to both identity proof practitioners and issue practitioners access to the electronic prescribing system to prescribe controlled substances, the entire system was vulnerable to compromise. Without separation of the identity and enrollment tasks, it could be quite easy for service provider staff to create a fraudulent identity and enroll that identity in the electronic prescribing system. While some service providers have asserted that their staffs are trustworthy, DEA did not want to establish a system which could be easily subverted for the diversion of controlled substances. Further, DEA was concerned that such a system may prove to be inconvenient for prescribing practitioners and service providers alike. Although DEA believes that many service providers would be on site at practitioners' offices routinely due to the complexity of the EHR systems of which electronic prescribing is often a part, DEA recognizes that conducting enrollment activities at that time may be inconvenient. Practitioners may not be at the practice location when the service provider staff is present. If enrollment could not occur, service providers' staff would have to make separate trips specifically for in-person identity proofing. Such trips could be difficult depending on the location of the service provider as compared to the practitioner. To address DEA's concerns that the identity proofing and enrollment functions not reside within the same entity, and to ensure that practitioners have ready access to the entities permitted to conduct in-person identity proofing, DEA is proposing that the following entities may conduct in-person identity proofing: • The entity within a DEA-registered hospital that has previously granted that practitioner privileges at the hospital (e.g., a hospital credentialing office); • The State professional or licensing board, or State controlled substances authority, that has authorized the practitioner to prescribe controlled substances; • A State or local law enforcement agency. DEA is proposing that before a service provider grants access to the electronic prescription system for the prescribing of controlled substances, the service provider must receive a document prepared by one of the above-listed entities regarding the conduct of the in-person identity proofing. DEA is proposing two alternatives for the format of the identity proofing document: The document may be prepared on the identity proofing entity's letterhead or other official form of correspondence, or the service provider may design a form for use by the identity proofing entity. Regardless of the format, the document must contain all of the following information: • The name and DEA registration number, where applicable, of the entity which conducted the in-person identity proofing of the practitioner; • The name of the person within the entity who conducted the in-person identity proofing of the practitioner; • The name and address of the practitioner whose identity is being verified; • For each State in which the practitioner wishes to prescribe controlled substances electronically, the name of the State licensing authority and State license number of the practitioner whose identity is being verified; • Except for individual practitioners who prescribe controlled substances using the DEA registration of the institutional practitioner, for each State in which the practitioner wishes to prescribe controlled substances electronically, the DEA registration number and date of expiration of DEA registration of the practitioner whose identity is being verified; • For individual practitioners who prescribe controlled substances using the DEA registration of the institutional practitioner, a statement by the institutional practitioner acknowledging the authority of the individual practitioner to prescribe controlled substances using the institution's DEA registration, and the specific internal code number assigned to the individual practitioner; • The type of government-issued photographic identification checked (e.g., the practitioner's driver's license, passport) and a statement that the photograph on the identification matched the person presenting the photographic identification; • The date on which the practitioner's in-person identity proofing was conducted; • The signature of the person within the entity who conducted the in-person identity proofing; • The signature of the practitioner who is the subject of the in-person identity proofing. Before granting the practitioner access to the system to sign controlled substances prescriptions, the service provider must check with each State and DEA to determine that the practitioner's State license to practice medicine is current and in good standing. In those States in which a separate controlled substance registration is required to prescribe controlled substances, the service provider must also check with the appropriate State authority to determine that the practitioner's State license is current and in good standing. Finally, to ensure that the application to gain access to sign controlled substances is legitimate, the service provider must contact the prescribing practitioner at the practitioner's registered location by telephone to confirm the practitioner's intent to apply to prescribe controlled substances using the service provider's system. The service provider must obtain the telephone number from a public source other than the application received from the practitioner. Alternatively, the service provider may confirm the practitioner's intent in person at the practitioner's registered location. The service provider must retain the document regarding identity proofing in its files for five years. DEA recognizes that in-person identity proofing will add a step to enrollment, but anything less would make it easy to steal a practitioner's identity and issue fraudulent prescriptions. In-person identity proofing will protect practitioners from this type of abuse. The records may be maintained electronically. DEA seeks comments on in-person identity proofing requirements, and those requirements' effects, if any, on practitioners, including those practicing at multiple locations. DEA also seeks comments regarding alternatives to in-person identity proofing that achieve the same or higher level of assurance as that which DEA is proposing here. *Authentication* . As explained above in the risk assessment, DEA is proposing that the authentication protocol must be two-factor and meet NIST SP 800-63 Level 4 criteria. One factor must be stored on a hard token that meets the FIPS 140-2 standard for the cryptographic module. The HIPAA Security Guidance issued by HHS on December 28, 2006, also recommends two-factor authentication, beyond a combination of password and user ID, although it does not detail how this should be implemented. 18 The standards for electronic health records system security developed by the Certification Commission for Healthcare Information Technology (CCHIT) require systems to support two-factor identification. 19 Consequently, all of the EHR systems certified by CCHIT (approximately 85 systems) already support two-factor authentication. The requirement to store the key on a token will not impose an incremental cost for these systems. 18 HIPAA Security Guidance for Remote Use of and Access to Electronic Protected Health Information December 28, 2006; *http://www.cms.hhs.gov/SecurityStandard/Downloads/SecurityGuidanceforRemoteUseFinal122806.pdf* . 19 CCHIT Security Criteria 2007 Final 16 Mar 07; criteria S21. *http://www.cchit.org/files/Ambulatory_Domain/CCHIT_Ambulatory_SECURITY_Criteria_2007_Final_16Mar07.pdf* . The highest form of protection would be three-factor authentication (something you know, something you have, and something you are), but given the difficulties that still exist in ensuring that biometric readers function accurately at all times, DEA decided not to require a biometric password. DEA notes that biometric authentication is not prohibited in this rule; DEA supports this method of authentication, but is not requiring it at this time. Practitioners may decide to use a biometric as one of the passwords; some systems, including some PDAs, have, or support the use of, a fingerprint reader for access control. Federal Information Processing Standard

(FIPS)140-1/140-2 is a standard entitled “Security Requirements for Cryptographic Modules.” 20 The standard is issued by NIST to lay out general requirements for cryptographic modules for computer and telecommunications systems. These standards ensure that cryptographic modules, which protect information such as passwords and other records, are robust enough that “breaking” the encryption is generally not feasible. The FIPS standards have been adopted by the United States government and are required for all cryptographic-based security systems that are used by, or approved by, Federal agencies to protect unclassified information. DEA, therefore, must require that the software modules used comply with these standards. A list of vendors whose cryptographic modules have been validated as FIPS 140-2 compliant may be obtained from the NIST Web site at *http://csrc.nist.gov/cryptval/140-1/1401val.htm* . As of March 2008, more than 900 modules have been certificated as compliant. The vendors include providers of PDAs, cell phones (Palm, Blackberry, Nokia), one time password tokens, as well as network and software providers. (When the FIPS 140-1 standard was updated to 140-2, all modules approved under the 140-1 standard were grandfathered and are considered compliant under 140-2.) 20 National Institute of Standards and Technology. FIPS 140-2 “Security Requirements for Cryptographic Modules”, May, 2001. *http://csrc.nist.gov/publications/PubsFIPS.html* . DEA notes that practitioners are not required to learn cryptographic keys; a password entered into a hard token accesses the key, which the service provider then recognizes. From the practitioner's perspective, the only difference from the common security controls on computer systems is that one of the keys is stored on a token. If that token is a PDA, the practitioner may not see a difference from the existing electronic prescription systems except when the practitioner wants to use a personal computer, when he would need to connect the PDA to the computer to access the system. *Authentication protocol expiration and revocation* . The practitioner's authentication protocol to sign controlled substances prescriptions is based on the validity of the practitioner's DEA registration and on the security of the hard token and password. DEA would require the service provider to revoke the practitioner's authentication protocol if the practitioner's DEA registration expires (unless the service provider determines that the registration has been renewed), is revoked, suspended, or terminated. DEA will make available to service providers information regarding the registration status of prescribing practitioners, including practitioners' names, addresses, DEA registration numbers, and dates of expiration for those DEA registrations. The service provider must check the DEA registration database at least once a week to ensure that the service provider has the most current DEA registration information. DEA will permit service providers to cache this information for one week from the date of issuance by DEA of the most current database. DEA seeks comment regarding the interval for updating by DEA of registration information to service providers. Further, DEA is proposing to require the service provider to revoke the authentication protocol used to sign controlled substance prescriptions immediately upon receiving notification from the practitioner that a password or token has been compromised, lost, or stolen. In such cases, the service provider may issue a new authentication protocol to the practitioner. DEA is interested in receiving comment regarding the current industry practices used to authenticate practitioners who use electronic prescribing systems for noncontrolled substances and whether and how such practices prevent noncontrolled substance prescription forgery, fraud, and other related crimes. *Access limitations and signing* . DEA is proposing a series of requirements related to the creation, signing, and transmitting of controlled substance prescriptions: • After authenticating to the system but prior to signing the controlled substance prescription, the system must present the practitioner with a statement indicating that the practitioner understands he is signing the prescription being transmitted. If he does not so indicate, the prescription must not be transmitted. • The electronic prescription system must include a function that requires a practitioner to electronically “sign” the completed prescription prior to transmission. The prescription file must include an indication that the prescription was signed. • The system must limit access to the signing function for controlled substances to practitioners authorized to sign controlled substance prescriptions. • The system must transmit the prescription immediately upon signature. • The system must not transmit the prescription unless it has been signed. DEA wishes to ensure that the act of signing controlled substances prescriptions is clearly understood by the practitioner. Therefore, DEA is proposing to require that, after authenticating to the system but prior to signing the controlled substance prescription, the system must present to the practitioner certain information regarding controlled substances prescriptions being transmitted. Specifically, the system must display for the practitioner the patient's name and address; the name of the drug being prescribed; the dosage strength and form, quantity, and directions for use; and the DEA registration number under which the prescription will be authorized. While this information is displayed, the practitioner must be presented with the following statement (or its substantial equivalent): “I, the prescribing practitioner whose name and DEA registration number appear on the controlled substance prescription(s) being transmitted, have reviewed all of the prescription information listed above and have confirmed that the information for each prescription is accurate. I further declare that by transmitting the prescription(s) information, I am indicating my intent to sign and legally authorize the prescription(s).” The practitioner must positively indicate agreement with this statement. Such agreement can be accomplished through a check box or other means determined by the system. If the practitioner does not indicate agreement to this statement, the controlled substances prescriptions may not be transmitted. DEA believes that such a statement is necessary to help to positively bind the practitioner to the prescription. DEA believes that this requirement is similar to many banking and online billing systems that require the user to agree to certain terms and conditions before billing or other financial transactions are permitted to occur. This statement will help to provide nonrepudiation of the prescriptions; that is, the inclusion of this statement will make it more difficult for the practitioner to deny having signed the controlled substance prescriptions. Although the requirement for signing may seem obvious, signing is not currently an automatic part of electronic prescriptions. The standard that the industry has developed and HHS has adopted for the transmission of electronic prescriptions (the National Council for Prescription Drug Programs (NCPDP) SCRIPT) does not include a field that indicates that the prescription has been signed. Signing an electronic prescription does not create a record of the act of signing; it is simply a function that usually is linked to transmission. The SCRIPT fields clearly provide for cases where someone other than the practitioner creates and transmits a prescription under the practitioner's supervision. Although this approach may be legal for prescriptions for noncontrolled substances, it is not legal for controlled substance prescriptions. Agents of a practitioner may prepare the prescription at the practitioner's direction, as they can with paper prescriptions, but only the registered practitioner may sign and issue the prescription. As noted above, the signature represents the practitioner's attestation of the validity of the prescription and legally binds the practitioner to the prescription. Another scenario that the SCRIPT standard allows is for two DEA registration numbers associated with two practitioners to appear on a single prescription; the standard allows a practitioner and supervisor to be identified with DEA registration numbers. This scenario is not acceptable for controlled substance prescriptions. The prescribing registrant is solely responsible for issuing the prescription; approval by a supervisor does not alter the legal liability of the prescribing practitioner for the validity of the prescription. Identifying two registrants on a prescription could lead to confusion about which registrant was legally responsible and create confusion in pharmacy record systems. To ensure that only authorized practitioners sign controlled substance prescriptions, the service provider must ensure that only DEA-registered practitioners are allowed to sign prescriptions for controlled substances and that each practitioner is uniquely identified. Specifically, the system must require that the DEA registrant whose DEA number is listed on the prescription sign the prescription. The system must not allow any other person to sign the prescription. Many office staff may have legitimate reasons to access the system, particularly when the electronic prescription capability is part of an EHR system. Some service providers now explicitly place limits on the level of access granted to various members of a practice. CCHIT Security Criteria require that EHR systems set access controls for specific tasks. DEA would require that all service providers do this if their systems will be used to issue controlled substance prescriptions. Nurses or other members of a practice staff may prepare the prescription, as they may with paper prescriptions, but the systems must allow only a practitioner authorized by the State and DEA to issue controlled substance prescriptions to sign and transmit the prescription. This requirement is necessary to prevent others with access to the system from creating and signing prescriptions. In a recent discussion of an electronic prescription system, the service provider indicated that the illegality of a staff member issuing a prescription was a sufficient deterrent to prevent this from happening just, the service provider stated, as it prevents staff from stealing prescription pads. 21 Office staff have stolen prescription pads to create fraudulent paper prescriptions and called in fraudulent prescriptions. That they can do so with paper prescriptions is not a reason to facilitate their illegal activities with electronic prescriptions. DEA also notes that medical identity theft—where patient records are sold or misused—is a crime that often involves insiders. The *Report on the Use of Health IT to Enhance and Expand Health and Anti-Fraud Activities* cited a study that found that 70 percent of identity theft cases involved insider theft of data. 22 21 *http://www.nationalerx.com/pdf/NEPSI-eRx-faq.pdf* . 22 The *Report on the Use of Health IT to Enhance and Expand Health Care Anti-Fraud Activities* , prepared for the Office of the National Coordinator, U.S. Department of Health and Human Services, September 30, 2005. *http://www.hhs.gov/healthit/hithca.html* . This requirement will protect practitioners by eliminating the possibility that a staff member will be able to issue controlled substance prescriptions unless the practitioner grants them access to his authentication methods, which would make the practitioner legally responsible for any prescriptions that staff created. This requirement is also consistent with the HIPAA Security Guidance, issued on December 28, 2006, which recommended setting authorization levels particularly for portable devices and health record systems that can be remotely accessed. DEA notes that role-based access control lists may need to be modified to comply with this requirement. Not every physician is a DEA registrant; not every DEA registrant is allowed to prescribe all Schedule II-V controlled substances. Authorizations for mid-level practitioners (e.g., nurse practitioners, physicians' assistants) vary across States. Service providers will need to ensure that their access control process reflects the actual authorizations of individuals and does not rely solely on roles. To ensure that a prescription cannot be altered once it is “signed,” DEA is proposing that the prescription must be transmitted immediately on signing. Practitioners would be able to create a group of prescriptions and store them to be signed later. Agents of the practitioner (e.g., nurses) could also, at the practitioner's direction, enter some or all of the data into an electronic prescription as they can do for paper prescriptions. The practitioner, however, must authenticate to the system to sign the prescription because the practitioner is the ultimate authority for the prescription. If others prepare all or part of prescriptions, the practitioner could authenticate to the system and sign one or more prescriptions simultaneously depending on the system. If the system allows a practitioner to sign multiple prescriptions at once, DEA would require that the practitioner be required to indicate separately that he or she intends to sign each controlled substance prescription listed; this can be done by checking a box as some systems currently do. The critical requirement is that once the prescription is signed, it must be immediately transmitted so that there can be no question that someone else at the office had the opportunity to alter it. Many existing systems already have this feature. DEA notes that systems may apply varying labels to the signing function (e.g., sign, transmit); DEA does not think it is necessary to change these labels. The critical element is that the practitioners understand that when they use the function, they are exercising their authority to issue a controlled substance prescription and that they are responsible for accuracy, completeness, and validity of the prescription. The other part of this requirement is that a controlled substance prescription must not be transmitted unless it has been “signed.” The system must be designed to prevent any transmission until the practitioner has “signed” the prescription. In addition, the system must not allow a prescription to be printed once it has been transmitted or to be transmitted if it was printed. These conditions are necessary to prevent a single prescription being used to generate multiple copies to be filled. As noted above, the NCPDP SCRIPT standard does not currently include a field for a “signature” or for any indication that the prescription has been signed. DEA would require that controlled substance prescriptions include an indication that the prescription was signed; this indication could be a single character field. The industry has indicated that this alteration is feasible. It will provide pharmacies with additional assurance that the prescription was issued legally. DEA welcomes comment on the current industry practices used to “sign” electronic prescriptions for noncontrolled substances and whether and how such practices prevent noncontrolled substance prescription forgery, fraud, and other related crimes. *Prescription data* . Electronic prescriptions must contain the same information that DEA requires for paper prescriptions (21 CFR 1306.05): The date of issuance of the prescription; practitioner's full name and address; practitioner's DEA registration number; patient's full name and address; drug name, strength, quantity, dosage form, and directions for use. DEA notes that for military or Public Health Service practitioners exempt from registration, the prescription must include the practitioner's service identification number or Social Security Number as required by 21 CFR 1306.05(h). This information may not be altered once the practitioner signs the prescription other than to reformat. The current version of NCPDP SCRIPT provides fields and codes for all of the required data elements, but not all of them are mandatory. For a controlled substance prescription, however, all of this information must be included. Other practitioner identifiers (State license number or National Provider Identifier) may not substitute for the DEA registration number. A system that completes practitioner and patient name and address only by linking to a National Provider Identifier

(NPI)number and insurance records is not sufficient for DEA purposes for two reasons. First, practitioners will have a single NPI, but they may have multiple DEA registrations, particularly if they practice in more than one State. A prescription must have the correct DEA registration and location. Second, a system that assumes that details on the patient will be filled in by linking to insurance files will not account for the part of the population that does not have prescription drug insurance. As discussed above, multiple prescribers and their DEA registration numbers on a single prescription are also not acceptable. Electronic prescription systems would not be allowed to transmit a prescription for a controlled substance unless all of the required elements are complete. DEA is also proposing to require that the system show the practitioner all of the DEA-required prescription information before the prescription is signed to ensure that a practitioner does not inadvertently misprescribe a controlled substance or sign a prescription created by an agent for his signature without having been presented with the contents. Although many systems do this, the RAND study indicated that some do not. In those cases, the practitioner sees only the drop down menus sequentially and may not have the opportunity to review the completed prescription. Where an agent enters the data for the prescription, it is particularly important that the practitioner be able to see the details to ensure that diversion is not occurring. DEA notes that the data may be presented in any format the system devises (e.g., arrayed like a paper prescription, a single line with the data selected shown); the essential items are the patient name and address, drug name, dosage form and units, quantity prescribed, directions for use, and the DEA registration number of the prescribing practitioner. DEA recognizes that systems may not routinely display the patient's address and seeks comments on whether displaying this information would pose technical problems. DEA believes it is important to allow the signing and transmission of more than one prescription simultaneously. However, it is critical that the practitioner know, and positively indicate, which prescriptions are to be signed and transmitted. Where more than one prescription has been prepared at any one time, DEA is proposing to require that, prior to authenticating to the system, the practitioner indicate which prescription(s) are to be signed and transmitted. Such indication could be as simple as checking a box associated with each prescription the practitioner wishes to sign and transmit. DEA is not proposing any requirements to address a circumstance in which a prescription is not indicated for signature and transmission. DEA would not allow alteration of any of the required information after the prescription is signed except to reformat. DEA does not believe that the intermediaries are altering the data because formulary checks appear to occur prior to signing. If, however, there are cases where the content of the required elements is altered (e.g., to change the prescribed drug to a generic drug) after signing, DEA would consider the prescription invalid and the parties that changed the data to have issued a prescription without being authorized to do so, a violation of the Controlled Substances Act. *Automatic timeout* . For security reasons, many computer systems now lock the computer if it is not used for a period of time, often 5 or 10 minutes. The user must then reauthenticate himself to the system before being able to use the computer again. This feature ensures that there is a very limited possibility that someone else could use the computer or PDA after the practitioner authenticates to the system. This requirement is unlikely to be a problem for electronic prescription systems run by ASPs; if the feature does not exist in installed systems, it will require some reprogramming. DEA notes that automatic timeout after system inactivity is required under the CCHIT security criteria for EHRs, so should not impose a burden on those system providers. DEA is proposing that if the system is inactive for 2 minutes after the practitioner authenticates to the system to sign controlled substances prescriptions, the system must require the practitioner to reauthenticate himself to the system. DEA notes that it is not proposing that practitioners authenticate themselves to the system before creating the prescription, but only when the practitioner is ready to sign and transmit the prescriptions. Practitioners may create multiple prescriptions or have staff create the prescriptions for one or more patients, then authenticate to the system and sign the entire set at one time if the system allows this. *Digitally Signed Records* . DEA is proposing that when an electronic prescription is signed and transmitted the first recipient would have to digitally sign and archive the digitally signed copy for five years from the date of issuance by the practitioner. Some electronic prescription systems already do this. In one case, the practitioner applies the service provider's digital signature when the practitioner signs the prescription; this is an acceptable practice under the proposed rule. Similarly, the first pharmacy system to receive the prescription (or the last intermediary transmitting it to the pharmacy) would have to digitally sign and archive a copy of the record as received. If the last intermediary digitally signs the record, it must forward both the record and the digitally signed copy to the pharmacy for dispensing. DEA notes that the service providers already have digital certificates. As explained in detail below, digitally signing a record ensures that DEA and other law enforcement agencies can prove that the record is the prescription that the practitioner signed and the record that the pharmacy received. Industry representatives have stated that their internal audit trails provide similar evidence of record integrity; audit trails are computer functions that record each time a record is opened or altered. DEA has two concerns with relying on such audit trails for proof of record integrity. First, insiders will know how to turn off or erase audit trails. If they want to alter a prescription or insert fraudulent new prescriptions, they may be able to do so without leaving a trace. Second, DEA and other law enforcement agencies cannot be in the position of having to prove that such alterations did not occur each time they have to prove that a practitioner signed fraudulent prescriptions or a pharmacy altered a record. The standard for criminal cases is “beyond a reasonable doubt.” If DEA relied on audit trails, it would have to subpoena both records and technical experts from each system and intermediary that handled each suspect prescription and hope that the possibility of insider action did not create a reasonable doubt. (As discussed in more detail below, insider threats to computer systems are relatively common.) The burden of relying on intermediary and service provider audit trails would fall on the service providers and intermediaries as well. Even a simple case against a single practitioner could require substantial time for each service provider and intermediary as they would need to produce records and experts to explain the systems to grand juries, attorneys on both sides, and petit juries. Many diversion cases are not simple. For example, in February 2007, a county district attorney in New York filed charges against a Florida pharmacy and at least six practitioners in a case involving diversion of steroids (Schedule III). The investigation involved at least 20 branch offices of State, local, and Federal agencies in four States with connected investigations in two other States. If the prescriptions had been electronic, each service provider and intermediary could have been required to make records and experts available to each investigating agency. Neither the service providers, intermediaries, nor law enforcement would be well served by a system that demanded the industry prove the integrity of its systems every time a case is brought against a practitioner or pharmacy. *Digital Signatures* . Digital signatures, as opposed to electronic signatures, are created as part of a public key infrastructure. A trusted party, a certification authority, conducts identity proofing and provides the subscriber with the means to generate an asymmetric pair of cryptographic keys. The subscriber retains control of the private key; the public key is available to anyone. What one of the keys encrypts only the other key can decrypt. When a person digitally signs a record, the text of the record is run through an algorithm that produces a fixed-length digest (known as the hash). The private key is used to encrypt the digest. The encrypted digest is the digital signature. When the record is sent to someone else, both the plain text and the digital signature are sent along with the signer's digital certificate, which includes the public key. If the recipient wants to confirm that the record has not been altered during transmission, the recipient can use the public key to decrypt the digest. This step confirms who sent the message (i.e., no one other than the holder of the private key could have sent the message and the holder cannot repudiate the message). The recipient's system can run the plain text received through the same hashing algorithm. If the two digests match, the recipient knows that the message sent has not been altered. The advantage of digital signatures is that they provide, in a single step, what other systems do not: a straightforward means of determining record integrity. If the first recipient of an electronic prescription signs it digitally, DEA will be able to prove what the practitioner signed. If the prescription is altered after that point, the practitioner will be able to demonstrate that he did not issue the altered prescription. Similarly, if the contents of the prescription sent and prescription received match, DEA and the intermediaries will be able to prove that the contents of the record were not altered in transit. DEA is not proposing that practitioners digitally sign prescriptions or that pharmacies routinely validate prescriptions that are digitally signed because the existing system of intermediaries makes this requirement infeasible. As explained above, electronic prescriptions often need to be reformatted during transmission. This reformatting makes it impossible to validate the digitally signed record. That is, the digest generated for the prescription signed will not match the digest generated for the prescription received if even a single space is changed. DEA is, therefore, proposing only that the prescription as sent by the prescribing practitioner and as received by the dispensing pharmacy be digitally signed and archived. This approach will enable DEA and other law enforcement agencies to prove what the practitioner signed and what the pharmacy received. The approach also allows the service providers to apply their digital signatures, which most of them already have, rather than requiring the 1.2 million DEA-registered practitioners to obtain digital certificates. Digital signatures are an integral component of secure transmission systems in use by businesses that use the Internet. The requirements for the digital signatures that the service providers or pharmacies apply are based on NIST FIPS standards for digital signatures and the hashing algorithm. Specifically, the signature would have to comply with FIPS 186-2, the digital signature standard. The algorithm used to process the record would have to comply with FIPS 180-2, the secure hash standard. Compliance with FIPS 186-2 requires compliance with FIPS 180-2. These standards are commonly used in the technology industry and, therefore, should not impose a burden on service providers; specifying the standards ensures the security of the digitally signed record. *Check on validity of the DEA registration* . DEA is proposing that the validity of the DEA registration must be checked prior to dispensing a prescription. For paper prescriptions, this responsibility rests with the pharmacy. If a pharmacist has reason to doubt the validity of a prescription, he is required to, among other things, check the registration of the prescribing practitioner to determine whether, in fact, the practitioner is authorized to prescribe controlled substances in the schedule of the prescription. Chain pharmacies sometimes purchase the CSA registration database to conduct these checks. To parallel the paper system, DEA would require that prior to dispensing the pharmacy verifies that the practitioner is authorized by DEA to issue the prescription. DEA recognizes, however, that any of the service providers or intermediaries could offer this check as part of their service. Therefore, DEA is proposing simply that the registration be checked at some point prior to dispensing; if the check occurs before the prescription is delivered to the pharmacy, the record must indicate that the check has occurred and that the prescription is valid. If an electronic prescription service provider chooses to check the validity before transmitting the prescription and indicate that the check has occurred and the registration is valid, that would meet the requirement as would checks by any intermediary or pharmacy service provider. This requirement will give pharmacies greater assurance than they now have that the prescription is legitimate. DEA notes that regardless of which party checks the validity of the prescribing practitioner's DEA registration, the pharmacy is solely responsible and liable for the dispensing of the controlled substance. A pharmacy that relies on an intermediary or its own service provider to conduct the check must ensure that the reliance is warranted. *Pharmacy system record requirements* . The pharmacy system must archive and retain the digitally signed prescription as received for five years from the date of receipt. The pharmacy system must require that each annotation include the information needed for paper prescription annotation (what was dispensed, by whom, and when). The annotated record or linked records must be maintained for five years. *System security requirements* . Beyond the requirements for handling controlled substance prescriptions at the point of origin, DEA is concerned about the security of the service providers' systems and whether that security protects against both insider and outsider threats. As noted above, insider threats may be a greater threat. Two FBI surveys on computer crime indicate that 42 to 44 percent of the companies surveyed reported insider misuse of their computer systems. 23 The 2006 survey also found that the most commonly used security technologies were directed toward outsiders. The Secret Service and Carnegie Mellon Institute have conducted studies of insider threats. They found that across all industries insiders who “attacked” company systems were likely to be disgruntled technology employees or former technology employees. In the financial sector, however, insiders did not hold technical positions. These insiders, who were usually acting for personal gain, attacked the system during work hours (70 percent) and in the work place (83 percent). In the financial sector, 78 percent of the cases involved modification or deletion of information. 24 23 2005 FBI Computer Crime Survey and the 2006 CSI/FBI Computer Crime and Security Survey. 24 Insider Threat Study: Illicit Cyber Activity in the Banking and Financial Sector, August 2004; Insider Threat Study: Computer System Sabotage in Critical Infrastructure Sectors, May 2005. DEA is particularly concerned about insider threats. Although it is possible for hackers to break into computer systems, most service providers have invested in security technologies to protect against outsider attacks. It would also be possible for someone to create identity documents good enough to convince a service provider that the person was a DEA registrant, but this could be a costly exercise that could involve setting up a fictitious office. It is more likely that someone outside or inside a service provider organization will find an insider willing to create a fictitious subscriber, using a real practitioner's name and DEA registration number, who can then issue fraudulent prescriptions that the system, intermediaries and pharmacies will assume are genuine. Staff at intermediaries could also create and transmit fictitious prescriptions. The profits to be made from such action would be sufficient to bribe service provider insiders or to tempt them to take action on their own. In addition, with 10 percent of the adult population abusing prescription drugs at some time, 25 it is likely that some insiders or their family members or friends may be addicted to prescription drugs that they cannot obtain as easily elsewhere. DEA does not question the good intentions of service providers or intermediaries, but it would be naïve to think that they are immune from the threat of insider action when it is so widespread across all industries. 25 Substance Abuse and Mental Health Services Administration. (2007). *Results from the 2006 National Survey on Drug Use and Health: National Findings detailed tables (Office of Applied Studies, NSDUH Series H-32, DHHS Publication No. SMA 07-4293. Rockville, MD. Table 1.18B—Nonmedical Use of Pain Relievers in Lifetime, Past Year, and Past Month by Detailed Age Category: Percentages, 2005 and 2006. http://www.oas.samhsa.gov/nsduh/2k6nsduh/2k6Results.cfm#TOC* . *Pharmacy internal audits* . For pharmacies, DEA is proposing that the pharmacy system include an internal audit trail; at the July 2006 public meeting regarding electronic prescriptions for controlled substances, the industry indicated that audit trails are a common feature of existing systems. The system operator would be required to define and implement a list of auditable events and conduct a daily analysis of the system to identify if any auditable events have occurred. The list of auditable events would have to include, at a minimum, attempted or successful unauthorized access, use, disclosure, modification, or destruction of information or interference with system operations in the controlled substances prescription system. The minimum list is based on the HIPAA definition of a security incident (45 CFR 164.304) and should, therefore, impose no new requirements on pharmacy systems, which are already subject to HIPAA. If the daily audit report identifies any events that indicate that the prescription system has been, or could have been, compromised, the pharmacy would be required to report this to DEA. *Pharmacy backup storage system* . DEA is also proposing that the pharmacy system have a backup storage system for the prescription records required to be maintained by DEA. The backup system would have to be at another location so that it would not be subject to the same hazards (e.g., fires, power surges) as the main server. Such backup systems are common features provided by pharmacy system ASPs. DEA believes that pharmacies will generally need such systems for normal business reasons, particularly as their records become solely electronic. Backup systems will prevent the loss of records that DEA has seen when pharmacies have fires or power surges between the time DEA, or another law enforcement agency, serves a subpoena and the time the records must be delivered. *Third-party audits* . DEA realizes that its registrants would not be able to determine, on their own, whether a particular service provider or system meets DEA's requirements. In addition, the security of the service provider's operations is critical to preventing insider threats and outsider attacks on the system. A registrant would have no way to determine whether a service provider had adequate protection against the range of potential security threats. It can be argued that service providers' primary goal is to sell their systems; the assertions that any service provider makes about its system cannot be accepted at face value. The accepted way for demonstrating that a system or a company is meeting a standard is to have a qualified third party audit the system or program and make a determination regarding the system's compliance. A qualified third party allows the party relying on the information the assurance that the determination is impartial and complete. DEA considered developing a series of security requirements derived from NIST SP 800-53, which details security requirements for Federal information technology systems, and mandating that compliance with the requirements be verified through a third-party audit. DEA has concluded, however, that separate detailed standards were not warranted because an alternative approach would provide equivalent assurance of security practices at a lower cost. Detailed requirements based on NIST SP 800-53 could limit the flexibility of service providers to develop different procedures and practices that meet the need for security. Many service providers may already have adequate security practices and procedures in place, which might have to be altered to meet a NIST SP 800-53 requirement. DEA is aware that most private sector companies are unfamiliar with NIST SP 800-53. In addition, auditors would have to develop new protocols, a cost that would be passed on to the service providers. Because there are relatively few service providers, it is possible that there would not be an incentive for auditors to develop a common protocol that could be applied nationally. Another Federal agency that created third-party audit standards based on NIST SP 800-53 indicates that audits of compliance with a NIST SP 800-53-derived standard cost at least $250,000. DEA, therefore, is proposing that rather than attempting to dictate security requirements, the Administration would require electronic prescribing system service providers and pharmacies to obtain a third-party audit that addresses security and processing integrity. The third-party audit would also give practitioners and pharmacies a basis for determining if their systems meet DEA's standards. DEA seeks comments on this approach and whether this approach is preferable to a NIST SP 800-53-based audit approach. Specifically, DEA is proposing that any system that will be used to create controlled substance prescriptions must have a third-party audit prior to accepting controlled substances prescriptions for processing and annually thereafter that meets the criteria for a SysTrust or WebTrust audit for security and processing integrity. For pharmacies, a SAS 70 audit would also be acceptable. As discussed below, SysTrust, WebTrust, and SAS 70 audits are professional services provided by qualified certified public accounting firms. For security, the audit determines whether the system is protected against unauthorized access (physical and logical); for processing integrity, the audit determines if the system processing is complete, accurate, timely, and authorized. SysTrust and WebTrust audits may also address issues of system availability, privacy, and confidentiality. Although practitioners and pharmacies may well be interested in these aspects of their systems, DEA does not believe that they are directly connected to the authentication and integrity of prescription records and, therefore, is not proposing to require audits that address these elements. Third-party audits are frequently used by companies to prove compliance with standards and regulations. Organizations such as the International Standards Organization

(ISO)routinely require third-party audits to demonstrate compliance and continuing compliance with its standards. Industry organizations, such as the American Chemistry Council, require third-party audits for their members to prove compliance with industry programs (e.g., Responsible Care in the chemical industry). The FDA recommends third-party audits for food processors and medical device manufacturers. The Federal Financial Institutions Examination Council (FFIEC), an interagency body that prescribes uniform principles, standards, and report forms for the Federal examination of financial institutions, allows third-party audits of technology service providers. Specifically, the Council cites American Institute of Certified Public Accountants (AICPA) Statement of Auditing Standards

(SAS)70 and Trust Services audits as providing the examination and information needed by Federally regulated financial institutions. FFIEC states that: SAS 70 provides a uniform reporting format for third-party reviews of technology service providers

(TSP)to facilitate the description and disclosure of the service provider's processes and controls to customers and their auditors. SAS 70 is a widely recognized standard and indicates that a service provider has had its control objectives and activities examined by an independent accounting and auditing firm. A formal report including the auditor's opinion (service auditor's report) is issued to the TSP at the conclusion of the SAS 70 process. The report contains a detailed description of the TSP's controls and an independent assessment of whether the controls are in place and suitably designed for the service provider's operations. The independent assessment of controls is based on testing certain controls to determine whether they are designed and operating with sufficient effectiveness to achieve the related control objective for the specified time period. 26 26 *http://www.ffiec.gov/ffiecinfobase/booklets/audit/audit_06_3_party.html* . SAS 70 audits are intended for the company's internal use. AICPA has developed two Trust Services audits to provide information to external users. FFIEC describes them as follows: SysTrust—In this type of review, a licensed CPA provides independent verification that a TSP has effective controls in place so that the system can function reliably. The institution prepares a description of the aspects of the system subject to be reviewed so that the scope of the review is clear to readers of the report. This system description is attached to the CPA's report. The auditor determines the presence of system controls and tests the effectiveness of the controls during the period covered by the SysTrust report. If the review is an attest-level engagement, the CPA firm's attestation is represented by the report to management and may also be represented by a SysTrust seal on the institution's Web site. WebTrust—The objective of a WebTrust engagement is for a licensed CPA to provide independent verification that an institution's Web site complies with the Trust Services Principles and Criteria in the particular subject matter reviewed (i.e., confidentiality, security, etc.). If the engagement is an attest-level review, assurance is represented by the CPA's report to management. An institution whose Web site has met the Trust Services Principles and Criteria in a particular subject matter area is eligible to display the WebTrust seal for that area to provide independent verification that an institution's Web site is in compliance. Clicking on the WebTrust seal reveals the date the seal was granted and the date it expires, the site's business practices and policies, Trust Services Principles and Criteria used to examine the site, the report of the independent accountant, as well as links to other sites with active WebTrust seals. 27 27 *http://www.ffiec.gov/ffiecinfobase/booklets/audit/audit_06_3_party.html* . Some electronic prescription systems already obtain these audits and display the seals on their Web sites. Because the AICPA Trust audits are already in use and widely recognized, DEA is proposing to specify their use. DEA, however, seeks comments on whether other recognized audit protocols exist that provide similar services to those covered by the SysTrust/WebTrust/SAS 70 systems. DEA recognizes that audits can be expensive; SysTrust audits can cost from $15,000 to $250,000 depending on the size of the company and complexity of the information technology system. These recognized audits, however, provide assurance to the service providers' customers and investors that the systems will protect them and their information. For prescribing systems, DEA is proposing that service providers must make the audit report available to any practitioner currently using the service provider's system and any practitioner considering use of the system. DEA believes that, at a minimum, the service provider must make the report available on its Web site, although a service provider may choose to make the report available through other means as well. If the third-party audit determines that the system does not meet one or more of DEA's regulatory requirements regarding the electronic prescribing of controlled substances, or does not provide adequate security against insider and outsider threats, the service provider must not accept for transmission any controlled substance prescription. The service provider would be required to notify practitioners that they should not use the system to generate and transmit controlled substance prescriptions. The service provider must also notify DEA of the adverse audit report and provide the report to DEA. For service providers that install the prescription-writing system on a practitioner's computers and that are not involved in the subsequent transmission of the prescription, the service provider must notify its DEA registrant customers of the results of any third-party audit that finds that the system does not meet one or more of DEA's regulatory requirements regarding the electronic prescribing of controlled substances. The service provider must also notify DEA of the adverse audit report and provide the report to DEA. The practitioner must determine initially and at least annually thereafter that the third-party audit report of the service provider indicates that the system and service provider meet DEA's regulatory requirements regarding the electronic prescribing of controlled substances. If the third-party audit report indicates that the system or the service provider does not meet the requirements of this part, or the service provider notifies the practitioner that the system does not meet the requirements of this part, DEA is proposing to require that the practitioner must immediately cease issuance of electronic controlled substance prescriptions using the system. As DEA has discussed throughout this rule, electronic prescribing of controlled substances is in addition to existing methods for prescribing of these substances. Therefore, DEA believes that this requirement will not impede the prescribing of controlled substances by practitioners. For pharmacy systems, DEA is proposing that service providers must make the audit report available to any pharmacy currently using the service provider's system. DEA believes that, at a minimum, the service provider must make the report available on its Web site, although a service provider may choose to make the report available through other means as well. If the third-party audit determines that the system does not meet one or more of DEA's regulatory requirements regarding the dispensing of electronic controlled substances prescriptions, or does not provide adequate security against insider and outsider threats, the service provider must not accept or process any controlled substance prescription. The service provider would be required to notify pharmacies that they should not use the system to accept and process controlled substance prescriptions. The service provider must also notify DEA of the adverse audit report and provide the report to DEA. For service providers that install the prescription-processing system on a pharmacy's computers and that are not involved in the subsequent processing of the prescription, the service provider must notify its DEA registrant customers of the results of any third-party audit that finds that the system does not meet one or more of DEA's regulatory requirements regarding the electronic prescribing of controlled substances. The service provider must also notify DEA of the adverse audit report and provide the report to DEA. *Prescribing logs* . DEA is proposing that electronic prescription service providers generate and send practitioners a log of all controlled substance prescriptions the practitioner has written in the previous month. The practitioner would be required to review the log and indicate to the service provider that the practitioner has reviewed it. A record of the indication that the review has occurred must be retained for five years. Further, DEA is proposing that the service provider must make available, at the practitioner's request, a record of all controlled substance prescriptions transmitted by the practitioner over the previous five years, the length of time for which the service provider is required to retain the digitally signed archive of the controlled substance prescriptions. DEA is not proposing that the pharmacy system generate dispensing logs, as they are required to do for refills under 21 CFR 1306.22. The internal audit trail and daily check for auditable events will serve to identify problem records without the need for a daily printout of the daily dispensing record. DEA recognizes that audit trails are not perfect and that insiders can subvert them. Diversion from pharmacies, however, usually involves pharmacy staff altering records to cover diversion or knowingly filling fraudulent prescriptions. Most pharmacists and other pharmacy staff are unlikely to be knowledgeable enough to be able to manipulate audit system controls. DEA seeks comments regarding these record requirements. Discussion of Other Proposed Rule Requirements A. Practitioner Requirements DEA emphasizes that the use of electronic prescriptions is voluntary. No registrant would be required by DEA to issue controlled substance prescriptions electronically. Those registrants that wish to do so, however, would have to comply with the rules governing electronic prescribing of controlled substances. DEA would require that practitioners who are registered in more than one State have a separate key to sign prescriptions for their registration in each State. Some practitioners hold multiple registrations within a single State because they administer or dispense controlled substances directly to patients at multiple locations. As a practical matter, however, they may issue prescriptions in the State under a single registration (see 71 FR 69478, December 1, 2006 for further discussion of this). Consequently, DEA is proposing that practitioners would need to have multiple access keys only when they practice in more than one State. The “keys” could be stored on the same hard token. The practitioner would be responsible for selecting the correct DEA registration to use to sign the prescription. The practitioner must ensure that only the practitioner uses the hard token and must not share the password with any other person. The practitioner must adopt procedures and controls to

(1)secure the hard token and password against loss, theft, or unauthorized use, and

(2)clearly identify any attempt to compromise the private key. In practice, a practitioner can secure the hard token by retaining physical control of it. The practitioner must not lend the token, whether it is a PDA, cell phone, smart card, or other device, to anyone. If the practitioner has reason to believe that the password or other method used to authenticate to the token has been compromised, the practitioner must notify the service provider as soon as possible, but no later than 12 hours after discovery, and change the authentication. The practitioner must report to the service provider the loss or theft of the hard token within 12 hours of identifying the loss or theft even if the practitioner does not believe that someone else will be able to authenticate to the system. If the hard token is lost or the key can no longer be accessed for any reason, the service provider must revoke the authorization to sign controlled substances prescriptions. If a practitioner fails to notify the service provider of the loss or compromise within 12 hours or if the practitioner purposefully allows someone else to use the hard token to create and sign electronic prescriptions, DEA will hold the practitioner responsible for any controlled substance prescriptions issued under his name. Regarding the third-party audits of electronic prescribing service providers' prescribing systems, the practitioner must determine initially and at least annually thereafter that the third-party audit report of the service provider indicates that the system and service provider meet the DEA requirements for electronic prescribing systems. If the third-party audit report indicates that the system or the service provider does not meet DEA's requirements, or the service provider notifies the practitioner that the system does not meet DEA's requirements, the practitioner must immediately cease to issue electronic controlled substance prescriptions using the system. B. Prescription Logs and Security Incidents The practitioner would be required to review the log of his controlled substance prescriptions transmitted by the service provider and indicate that he has reviewed the log; the indication can be as simple as checking a box. DEA emphasizes that it does not expect practitioners to crosscheck the log with medical records. DEA expects practitioners to review the list to determine if something seems unusual, such as prescriptions for a patient the practitioner has not seen, prescriptions for substances the practitioner does not usually prescribe, or more prescriptions for a particular controlled substance than a particular patient would normally require. If the practitioner finds problems, the practitioner would be required to notify DEA and the service provider within 12 hours. Pharmacy systems would also be required to conduct a daily analysis of the pharmacy system audit trail to check for auditable events. If an auditable event occurs, the pharmacy must determine whether it represents a security incident that compromised, or could have compromised, the integrity of the prescription system and report any such incidents to the system provider and DEA within one business day. Both the practitioner log check and the pharmacy audit trail analysis will assist registrants, service providers, and DEA in identifying any diversion that has occurred. Finally, DEA is proposing that service providers must audit their records and systems at least once a day. Service providers would be required to notify DEA of any security incidents that could compromise the security of controlled substance prescriptions. These incidents would include, but not be limited to, the discovery that prescriptions were being written by nonregistrants (identity theft), that access had been granted without proper identity proofing, that prescriptions were being or could have been altered after transmission, or that outsiders had penetrated the system. C. Electronic Records and Record Retention *Record retention* . The CSA (21 U.S.C. 827(b)(3)) requires that records of dispensing, i.e., prescriptions retained by pharmacies, shall be kept and made available “for at least two years” for inspection and copying by authorized personnel, including DEA. As DEA has noted previously, however, many States require that these records be maintained for longer periods of time. DEA reviewed existing State board of pharmacy requirements regarding record retention and found that 21 States require that records be retained for two years, nine for three years, one for four years, 17 for five years, one for six years, and one State required that records be retained for seven years. As has been mentioned throughout this document, electronic prescribing poses new threats and vulnerabilities for diversion due to the increased velocity of these authenticated automated transactions. Unlike the paper system, where only one prescription is created and provided to a patient who brings that prescription directly to the dispensing pharmacy, electronic systems provide the opportunity to create and transmit many prescriptions simultaneously. These many prescriptions can be simultaneously transmitted to pharmacies over a broad geographic area, without the need to physically move a paper prescription from one location to another. Further, as DEA has discussed, the introduction of service providers and other intermediaries into the system poses new vulnerabilities for insider attacks on the electronic prescribing systems. DEA is concerned that a significant amount of time may elapse between the time a controlled substance is diverted and the time DEA becomes aware of the potential or suspected diversion. DEA is also concerned that administrative, civil, and criminal cases will become more complex and time-consuming as more parties become involved in the movement of the prescription from the practitioner to the pharmacy. The statute of limitations for non-capital offenses is five years. That is, the United States cannot prosecute, try, or otherwise punish anyone for any non-capital offense unless the person is indicted, or an information instituted, within five years after the offense was committed (18 U.S.C. 3282). Due to the potential length and complexity of cases relating to the diversion of electronic prescriptions for controlled substances, DEA believes that a longer retention period is necessary and permissible within its statutory authority. Therefore, to address these concerns, DEA is proposing to require that all records regarding electronic prescribing of controlled substances be maintained for five years from the date the record was created. This record retention requirement shall not pre-empt any longer period of retention which may be required now or in the future, by any other federal or State law or regulation, applicable to practitioners, pharmacists, or pharmacies. Records affected by this requirement would include, but are not necessarily limited to: • The document received by the service provider from an entity permitted to conduct in-person identity proofing regarding the conduct of that in-person identity proofing for the specific practitioner. • The electronic controlled substance prescription as digitally signed by the service provider or first processor. • The electronic controlled substance prescription as digitally signed by the pharmacy or last intermediary. • The dispensing annotations added to or linked to the prescription record. • The backup copy of the pharmacy controlled substances prescription records. • The internal audit trail records created by the pharmacy system. • The monthly log of controlled substances prescriptions provided to each practitioner by the practitioner's service provider and the record of the indication by the practitioner that the log has been reviewed. • The third-party SysTrust, WebTrust, or SAS 70 report of the electronic prescribing or pharmacy system. DEA believes that these record retention requirements will not pose any new burdens on service providers and pharmacies. Many service providers indicate that they retain these records for longer periods of time, to comply with State laws and other Federal agency requirements. Further, as all of the records in question can be retained electronically, there will be limited costs associated with the storage of these records. DEA seeks comment regarding the extent to which service providers and intermediaries store electronic records of noncontrolled substance prescriptions. *Electronic Records* . DEA is proposing that pharmacies must maintain records of electronic prescriptions and any linked records for five years. Records must be maintained electronically. Records regarding controlled substances that are maintained electronically must be immediately retrievable from all other records by prescriber's name, patient's name, drug dispensed, and date filled. They must be easily readable or easily rendered in a human readable format. The databases in which prescription records are maintained must be capable of exporting the records into database or spreadsheet format that will allow the data to be sorted by prescriber name, patient name, drug dispensed, and date filled. Such records must be made available to the Administration upon request. Records must also be capable of being immediately printed upon request. D. Preventing This Rule From Being Exploited by Rogue Internet Operators In recent years, there has been a significant rise in the amount of prescription controlled substances sold without a legitimate medical purpose by Internet-based entities such as so-called “rogue Internet pharmacies.” The typical “rogue Internet pharmacy” is actually a criminal conspiracy run by a Web “entrepreneur” who contracts with one or more unscrupulous DEA-registered practitioners to write prescriptions and one or more unscrupulous DEA-registered pharmacies to fill the prescriptions. Drug seekers easily find their way onto these Web sites through an Internet search engine (such as by typing the search terms “hydrocodone no prescription”) or through spam e-mail advertisements. Once on such sites, the drug seeker is immediately shown a price list of controlled substances (with such prices usually inflated well above those of a legitimate pharmacy). After the drug seeker chooses the drug(s) he wants, the Web site assists the buyer in obtaining a prescription from an unscrupulous practitioner employed by the site, who has no bona fide doctor-patient relationship with the buyer. Generally, all that is needed for the buyer to obtain a prescription is to supply a credit card number, fill out a questionnaire and, in some cases, fax in some form of “documentation” that purports to show a medical condition. The prescribing practitioner employed by the typical rogue Web site never sees the drug buyer in person, conducts no meaningful review of the documentation supplied by the buyer, and makes no attempt to rule out the possibility that the “medical records” supplied by the buyer are fraudulent. Instead, the practitioner employed by these sites generally writes as many prescriptions as possible, often from a location far from the patient. For example, DEA has found evidence that many practitioners located in the Caribbean have been employed by rogue Web sites to write prescriptions for “patients” located throughout the continental United States. Once the prescription has been generated, the same Web operation typically arranges for the prescription to be transmitted to the unscrupulous brick-and-mortar pharmacy, which fills it unquestioningly, turning a blind eye to the circumstances under which it was issued. Using the foregoing methods, DEA estimates that the total amount of controlled substances illegally distributed via the Internet is well in excess of 100 million dosage units per year. DEA has taken numerous enforcement actions recently to shut down pharmacies, practitioners, and distributors found to have misused their DEA registrations to facilitate this Internet-based diversion. Yet, even with focused enforcement efforts, there will remain some unscrupulous individuals who will continue to seek to exploit the anonymity of the Internet to profit from the illegal sales of controlled substances. Moreover, given that a single rogue Web site can divert enormous amounts of controlled substances throughout the United States in a relatively short period of time, allowing such sites to operate even for brief periods can cause substantial harm to the public health and safety. It is, therefore, essential that DEA avoid any regulatory action that could be exploited by such rogue actors. Based on the historical practices of these rogue Web sites and the claimed legal defenses they have put forth (asserting, for example, that their “business model” is having practitioners prescribe controlled substances without ever seeing the “patient” and without establishing a legitimate doctor-patient relationship), DEA is particularly concerned that the operators of these rogue sites might attempt to use this proposed rule as a justification for their illicit activities or to expand upon such activities. Absent a clear statement to the contrary in the regulations, operators of rogue sites might argue that, if their site generates prescriptions for controlled substances that are transmitted using electronic prescriptions in a manner that complies with authentication requirements of this proposed rule, they are automatically engaging in legal activity. Of course, all prescriptions for controlled substances must be issued for a legitimate medical purpose in the usual course of professional practice. Mere compliance with the authentication requirements of this proposed rule with respect to a given prescriptions does not—by itself—establish that the prescription was issued for a legitimate medical purpose. To avoid any possible confusion about this point, the proposed rule contains a provision that reaffirms this basic principle. In addition, to minimize the likelihood that operators of rogue Internet sites would attempt to exploit this proposed rule, DEA wishes to reiterate some additional basic principles that the agency has stated in prior **Federal Register** documents. First, it is axiomatic that, in the absence of a bona fide doctor-patient relationship, a practitioner cannot satisfy the requirement of issuing a prescription for a legitimate medical purpose in the usual course of professional practice. 28 An arrangement whereby a Web site solicits drug seekers and refers them to practitioners who issue prescriptions for controlled substances without ever having seen the patient in person, based solely on such unreliable information as an online questionnaire, telephone conversation, or faxed documents that purport to be a drug buyer's medical records, inherently fails to satisfy the requirement of issuing a prescription for a legitimate medical purpose in the usual course of professional practice. 29 This is true regardless of whether the rogue Web site that operates in such a fashion utilizes paper, oral, faxed, or electronic prescriptions. Thus, it bears repeated emphasis that the use of electronic prescriptions in accordance with this proposed rule will in no way relieve the practitioner of the longstanding obligation to issue a prescription for a controlled substance only for a legitimate medical purpose in the usual course of professional practice. Likewise, as has always been the case, a corresponding responsibility will continue to rest with the pharmacist who fills the electronic prescription to ensure not only that the prescription was issued in accordance with the provisions for electronic prescribing contained in this proposed rule, but further that the prescription was issued for a legitimate medical purpose in the usual course of professional practice. 28 *See United Prescription Services, Inc* . (72 FR 50397, August 31, 2007); *Southwood Pharmaceuticals, Inc* . (72 FR 36487, July 3, 2007); *Trinity Health Care Corp., D/B/A/ Oviedo Discount Pharmacy* (72 FR 30849, June 4, 2007); *William Lockridge, M.D.* , (71 FR 77791, December 27, 2006); *Dispensing and Purchasing Controlled Substances over the Internet* , (66 FR 21181, April 27, 2001). 29 *Id.* E. Other Prescription Issues Transfers A pharmacy would be allowed to transfer an original unfilled electronic prescription to another pharmacy if that pharmacy is unable to or chooses not to fill the prescription. A pharmacy would also be allowed to transfer an electronic prescription with remaining refills to another pharmacy for filling provided the transfer is communicated between two licensed pharmacists. The pharmacy transferring the prescription would have to void the remaining refills in its records and note in its records to which pharmacy the prescription was transferred. The notations may occur electronically. The pharmacy receiving the transferred prescription would have to note from whom the prescription was received and the number of remaining refills. Applicability of Current Rules The CSA provides that a pharmacist may only dispense a controlled substance in Schedule II pursuant to a written prescription, except in emergency circumstances, where a pharmacy may dispense pursuant to an oral prescription (21 U.S.C. 829(a)). The CSA further provides that a pharmacist may dispense a Schedule III and IV prescription pursuant to either a written or an oral prescription (21 U.S.C. 829(b)). The CSA was enacted in 1970, long before the advent of electronic prescriptions, and thus the Act makes no mention of electronic prescriptions. As a result, electronically created and transmitted prescriptions are subject to the same provisions of the CSA and DEA regulations that apply to paper prescriptions. The DEA regulations provide, as set forth in 21 CFR 1306.11 and 1306.21, that a pharmacist may dispense a controlled substance under a written prescription signed by the practitioner. This requirement applies equally to manually written and electronically written prescriptions. In either case, the prescription can be prepared by an agent of the practitioner, such as a nurse or office assistant, but only the practitioner can apply his signature to that prescription. Of course, for Schedule III through V controlled substances, the prescription could still be transmitted orally or by facsimile (including a manual signature by the practitioner) to the pharmacy at the practitioner's discretion. IX. Summary of Proposed Rule Requirements As has been discussed throughout this rulemaking, DEA is proposing electronic prescribing of controlled substances as an addition to, not a replacement of, existing prescribing and dispensing methods already permitted by the CSA and DEA regulations. DEA has discussed its law enforcement concerns as they relate to electronic prescribing and dispensing of controlled substances. Any requirements DEA implements for electronic prescribing and dispensing of controlled substances must ensure that DEA and other law enforcement needs under the Controlled Substances Act and implementing regulations can be met. DEA is convinced that its concerns can be addressed without creating insurmountable barriers to electronic prescribing. In addition, DEA wishes to adopt an approach that is flexible enough that future changes in technologies will not make the system obsolete or lock registrants into more expensive systems. As has been discussed throughout this rulemaking, many of the requirements DEA is proposing are already required by other Federal agencies or third-party organizations, and are in practice in electronic prescribing and electronic pharmacy systems today. The table below summarizes the requirements DEA is proposing by this rule, the rationale for each, and the current implementation status of each requirement. Table 6.—Summary of Proposed Requirements for Electronic Prescriptions for Controlled Substances Requirement Rationale Current practice In-person identity proofing § 1311.105 Ensures only DEA registrants are granted access and protects against identity theft Prescribing practitioners have ready access to hospitals, State licensing boards, and State/local law enforcement agencies, any of which may conduct in-person identity proofing. Check validity of State license and DEA registration § 1311.105 Ensures that only eligible practitioners are granted access At least some service providers already do this. Maintain record of identity proofing § 1311.105 Provides a record that protects both the practitioner and service provider Two-factor Level 4 authentication § 1311.110 Provides a direct link between the prescriber and prescription; prevents misuse of passwords without the practitioner's knowledge. Protects the practitioner from staff issuing prescriptions in the practitioner's name EHRs certified by CCHIT must support 2-factor authentication so majority of existing systems have this capability. HIPAA security guidance recommends 2-factor authentication. Limit access to signing function § 1311.125 Ensures that only authorized registrants may sign controlled substance prescriptions EHRs certified by CCHIT must do this so majority of existing systems have this capability. Automatic lockout after a period of inactivity § 1311.110 Ensures that system cannot be accessed by other people once the practitioner has authenticated to the system EHRs certified by CCHIT must do this so majority of existing systems have this capability. Prescription must contain all DEA data elements § 1311.115 Meets the legal requirements for a controlled substance prescription All systems should already have this capability. Present the required data elements to the practitioner § 1311.120 Ensures that the practitioner has the opportunity to identify any miskeying Most systems present the full prescription information on a single screen. Indicate that each prescription is ready to be signed § 1311.120 Ensures that the practitioner has positively indicated that the prescription is to be transmitted when multiple prescriptions are being signed at one time Some existing systems already do this, requiring practitioners to check off each prescription they want to sign. Authenticate to the system just before signing § 1311.125 Ensures that only the practitioner signs the prescription Unclear when current systems require authentication. At least one requires entry of separate password to sign. Transmit as soon as signed § 1311.130 Prevents any alteration after the practitioner has signed May be common practice in existing systems because signing is the equivalent of transmitting. Do not transmit if printed; do not print if transmitted § 1311.130 Prevents other staff from printing extra copies that can be used to divert May be a new function for most systems. (This requirement does not prevent printing a copy of a medical record.) Indicate that the prescription was signed § 1311.125 Provides assurance to pharmacy that the practitioner authorized the prescription A new field for electronic prescriptions; industry has indicated that this is not a problem. Generate monthly logs for practitioner review § 1311.140 Provides practitioner a chance to review record and identify problems All systems should be able to generate records. First recipient digitally signs the prescription as transmitted § 1311.130 Provides record integrity. Ensures that DEA and the practitioner can prove what the practitioner signed At least one service provider is already doing so. Service providers all have digital certificates and the capability to sign records digitally. Do not convert to fax if cannot be delivered § 1311.130 Faxed prescriptions must be manually signed. Converting an electronic file to a fax during transmission creates an invalid written prescription May alter existing practice for some intermediaries. HHS has proposed removing an exemption from the SCRIPT standard for faxes. No alteration of the content during transmission except for formatting § 1311.130 Protects against changes during transmission Industry says this does not happen so requirement should not impose a burden. First pharmacy (or last transmitter) digitally signs the prescription as received § 1311.160 Provides record integrity. Ensures that DEA and the pharmacy can prove what the pharmacy received. Eliminates the need to examine the intermediaries' records in most cases and provides a basis for identifying alteration at the pharmacy Intermediaries and at least some pharmacy system providers have digital certificates and the capability to sign records. Check the validity of the prescriber's DEA registration (Pharmacy) § 1311.165 Ensures that the practitioner is still authorized to issue prescriptions Many pharmacies already check the DEA database for registration information. Store all of the DEA data in the pharmacy system § 1311.165 Parallels paper records Pharmacy systems already do this. Some may have problems with extensions to DEA numbers. Have an internal audit trail and analyze for auditable events (Pharmacy) § 1311.170 Provides a record of who annotated or altered a prescription. Needed to identify diversion at the pharmacy Most systems have this capability. Electronic prescription records stored electronically. (pharmacy) § 1311.180 All information is created and received electronically Pharmacy systems already maintain electronic information for paper prescriptions. Have a backup system for records at another location. (Pharmacy) § 1311.170 Protects against loss of records (accidental or intentional) Many pharmacy system providers, particularly ASPs, have such backup systems. SysTrust, WebTrust, or SAS 70 audit § 1311.150, § 1311.170 Provides assurance of the physical and processing integrity of the system. Protects against insider and outsider attacks on the system At least one service provider already has adopted this audit. Report security incidents § 1311.145, § 1311.155, § 1311.170 Provides system provider and DEA with immediate notice of potential problems Imposes no system requirements. X. Section-By-Section Discussion of the Proposed Rule In Part 1300, DEA is proposing to add a new § 1300.03, definitions relating to electronic orders for controlled substances and electronic prescriptions for controlled substances. The definitions currently in § 1311.02 would be moved to § 1300.03. Definitions of the following would be added: Audit, audit trail, authentication, authentication protocol, electronic prescription, hard token, identity proofing, intermediary, paper prescription, PDA, service provider, token, and valid prescription. In addition, a definition of NIST special publication 800-63 and SAS 70, SysTrust, and WebTrust would be added. Where possible, DEA is proposing to use definitions taken from NIST publications (audit, audit trail, authentication, authentication protocol, hard token, identity proofing, service provider, and token). DEA is using standard definitions developed for information technology systems to reduce the possibility that service providers will be confused by definitions as they might be if DEA translated the definitions into “plain” language. DEA is also proposing to add a definition of “intermediary” to cover any system that receives and transmits an electronic prescription after it is signed and before it is received by a pharmacy system. An intermediary could be the original service provider if it is the first recipient of the prescription, SureScripts or any other system that processes and reformats prescriptions, and a pharmacy system provider if it processes a prescription before routing it to the pharmacy. Further, definitions of electronic and paper prescription would be added. The definition of electronic prescription would state that an electronic prescription must meet the requirements of parts 1306 and 1311. The definition also clarifies that a computer-generated prescription that is printed out or faxed is not an electronic prescription for DEA purposes. The definition of paper prescription clarifies that such prescriptions can be created on paper or computer-generated to be printed or faxed; all paper prescriptions must be manually signed. Finally, the definition of valid prescription from § 1300.02 would be repeated in the new section. In Part 1304, § 1304.04 would be revised to limit records that cannot be maintained at a central location to paper order forms for Schedule I and II controlled substances and paper prescriptions. In paragraph (b)(1), DEA would remove the reference to prescriptions; all prescription requirements would be moved to paragraph (h). Paragraph (h), which details pharmacy recordkeeping, would be revised to limit the current requirements to paper prescriptions and to state that electronic prescriptions must be retrievable by prescriber's name, patient name, drug dispensed, and date filled. The electronic records must be in a format that will allow DEA or other law enforcement agencies to read the records and manipulate them; preferably the data would be downloadable to a spreadsheet or database format that allows DEA to sort the data. The data extracted should only include the items DEA requires on a prescription. Records would also be required to be capable of being printed upon request. In Part 1306, prescriptions, § 1306.05 would be amended to state that electronic prescriptions must be created and signed using a system that meets the requirements of part 1311 and to limit some requirements to paper prescriptions (e.g., the requirement that certain paper prescriptions have the practitioner's name stamped or hand-printed on the prescriptions). The section would also add “computer printer” to the list of methods for creating a paper prescription and clarify that a computer-generated prescription that is printed out or faxed must be manually signed. DEA is aware that in some cases, an intermediary transferring an electronic prescription to a pharmacy may convert a prescription to a facsimile if the intermediary cannot complete the transmission electronically. For controlled substance prescriptions, this is not an acceptable solution. The intermediary must notify the practitioner that the transmission could not be completed and have the practitioner create and sign a written prescription (for Schedule III, IV, or V controlled substances) before faxing it to the pharmacy. For most Schedule II prescriptions, the practitioner would have to provide a written prescription to the patient if notified that the transmission failed. The section would also be revised to divide paragraph

(a)into shorter units. Section 1306.08 would be added to state that practitioners may sign and transmit controlled substance prescriptions electronically if the systems used are in compliance with part 1311 and all other requirements of part 1306 are met. Pharmacies would be allowed to handle electronic prescriptions if the pharmacy system complies with part 1311 and the pharmacy meets all other applicable requirements of parts 1306 and 1311. Sections 1306.11, 1306.13, and 1306.15 would be revised to clarify how the requirements for Schedule II prescriptions apply to electronic prescriptions. Section 1306.21 would be revised to clarify how the requirements for Schedule III-V prescriptions apply to electronic prescriptions. Section 1306.22 would be revised to clarify how the requirements for Schedule III-IV refills apply to electronic prescriptions and to clarify that requirements for electronic refill records for paper, fax, or oral prescriptions do not apply to electronic refill records for electronic prescriptions. Pharmacy systems used to process and retain electronic controlled substance prescriptions would have to comply with the requirements in part 1311. In addition, DEA is proposing to break up the text of the existing section into shorter paragraphs to make it easier to read. Section 1306.25 would be revised to include separate requirements for transfers of electronic prescriptions. These revisions are needed because an electronic prescription could be transferred without a telephone call between pharmacists. Consequently, the transferring pharmacist must provide, with the electronic transfer, the information that the recipient transcribes when accepting an oral transfer. Section 1306.28 would be added to state the basic recordkeeping requirements for pharmacies for all controlled substance prescriptions. These requirements are now in § 1304.22 and remain there as well. DEA is proposing to add them to part 1306 to place all of the requirements in a single part on prescriptions. Part 1311 would be amended to add requirements related to electronic prescriptions for controlled substances. Section 1311.02 providing definitions related to electronic orders for controlled substances would be revised to remove the definitions and replace them with a cross reference to new § 1300.03. Section 1311.08 would be amended to add an incorporation by reference for NIST Special Publication 800-63. A new subpart C would be added for the rules that govern the systems that may be used to issue and process electronic controlled substance prescriptions and the responsibilities of practitioners and pharmacies. In § 1311.100, DEA would state that only DEA registrants or persons exempted from registration under part 1301 would be allowed to issue electronic prescriptions for controlled substances and only if they use a system and service provider that meet the requirements of part 1311. An electronic prescription for controlled substances issued through a system and service provider that did not meet the requirements of part 1311 would not be considered valid. The section would reiterate the requirement from § 1306.05 that the practitioner is responsible if the prescription does not conform in all essential respects to the CSA and implementing regulations. Sections 1311.105 through 1311.150 would establish minimum requirements that a service provider and system must meet before a practitioner would be able to use the system to create and sign an electronic controlled substance prescription. Although the service providers and their systems must meet the requirements, the ultimate responsibility rests on the practitioner to use only a system and service provider that comply with DEA's requirements. Section 1311.105 would require that the service provider receive a document regarding in-person identity proofing of the prescribing practitioner by an entity authorized by DEA to conduct the identity proofing. The service provider must check the DEA registration and State licensure to ensure they are current and in good standing, and maintain records of the identity proofing. Section 1311.110 would require the system to use two-factor authentication that meets the requirements of NIST SP 800-63, level 4 as discussed above. The practitioner must reauthenticate to the system if the system is inactive for more than 2 minutes. The system must provide separate authentication protocols for separate DEA registrations that a practitioner uses to issue controlled substances prescriptions. Finally, the authentication protocol must expire no later than the expiration date of the DEA registration with which it is associated. A DEA registration is valid for three years and can be renewed prior to its expiration. Section 1311.115 would require that electronic prescriptions for controlled substances contain all of the information required under paragraph

(b)of that section and § 1306.05. It would also require that a controlled substance prescription include only the DEA number and practitioner information for the prescribing practitioner. As discussed above, the SCRIPT standard allows multiple DEA numbers to be associated with a prescription; this is not acceptable to DEA. Section 1311.120 would set the requirements for creating an electronic prescription as discussed above. Consistent with current regulations governing paper prescriptions, DEA is proposing that the electronic prescribing system may allow the registrant or his agent to enter data for a controlled substance prescription, but only the registrant may sign and authorize the prescription. This would include the requirement that, where more than one controlled substance prescription has been prepared, the practitioner positively indicate that he has reviewed and approved the information for each prescription prior to signing and authorizing electronic transmission of the prescriptions. Section 1311.125 would set the requirements for signing an electronic prescription as discussed above. This would include the practitioner's declaration that information contained in the record constitutes the practitioner's legal authorization and signature. Section 1311.130 would require that the system transmit the prescription immediately upon signing. The section would disallow the printing of an electronically transmitted prescription and would also disallow the electronic transmission of a printed prescription as discussed above. These requirements are to prevent an individual electronic prescription from being transmitted more than once to a pharmacy (or pharmacies). The service provider or first recipient would be required to digitally sign and archive a copy of the prescription as received. Finally, the section would specify that the DEA required contents of the prescription could not be altered after signature without rendering the prescription invalid. The contents could be reformatted; reformatting includes altering the structure of fields or machine language so that the receiving pharmacy system can read the prescription and import the data into the system. Section 1311.135 would set the requirements revoking the authentication protocol used to sign controlled substances prescriptions upon notification that the password or token has been compromised, lost, or stolen or when the DEA registration expires unless the registration has been renewed and at any time that the registration is suspended or revoked. Section 1311.140 would require the service provider to generate and transmit to the practitioner a log of all controlled substance prescriptions written under the practitioner's DEA number in the previous month. The section would also require that the service provider make available, at the practitioner's request, a record of all controlled substance prescriptions transmitted over the previous five years. Section 1311.145 would require the service provider to notify DEA of certain security incidents, as discussed above. Section 1311.150 would require each service provider to have at least an annual third-party SysTrust or WebTrust audit for security and processing integrity as well as compliance with part 1311. Audits must be conducted prior to accepting any controlled substances prescriptions for transmission and annually thereafter. The audit report must be made available to any practitioner using or considering use of the system. If the audit finds that the system does not meet the requirements of the part, the service provider must not transmit controlled substance prescriptions and must notify practitioners that they should not attempt to send electronic controlled substance prescriptions until the problems have been addressed and another audit indicates that the system meets the requirements of part 1311. Section 1311.155 would specify the practitioner's responsibilities as discussed above. The section would require practitioners to check the third-party audit reports and notifications from the service providers about system inadequacies and cease to use the system for controlled substance prescriptions if the audit report or service provider indicated problems. The practitioner would be required to provide, or cause to be provided, documents regarding in-person identity proofing to the service provider. The practitioner would be required to maintain sole possession of the hard token and notify the service provider no later than 12 hours after the discovery of its loss or theft or any indication that the hard token had been compromised. The practitioner would be required to check the monthly log and indicate having done so. The section would reiterate that the practitioner has the same responsibility for the validity of an electronic prescription as the practitioner does for a paper prescription. Section 1311.160 would require the pharmacy or the last system transmitting the prescription to the pharmacy to digitally sign and archive the prescription record. Section 1311.165 would require the pharmacy to check the validity of the DEA registration prior to dispensing the prescription. The pharmacy system must reject a controlled substance prescription if it is not signed or is otherwise not valid. The pharmacy system would have to be able to include all of the information required under part 1306 in the electronic record and be capable of downloading the records in a readable and sortable format, as well as printing the records, if requested. Section 1311.170 would specify the security requirements for the pharmacy system including a backup storage system at another location, maintaining an internal audit trail, the implementation of a list of auditable events, a daily internal audit to identify if any auditable events have occurred, reporting any security incidents that could affect the integrity of the prescription records, and the annual SAS 70 or SysTrust audit. Audits must be conducted prior to accepting any controlled substances prescriptions for processing and annually thereafter. The audit report must be made available to any pharmacy using or considering use of the system. If the audit finds that the system does not meet the requirements of the part, the service provider must not process controlled substance prescriptions and must notify pharmacies that they should not attempt to process electronic controlled substance prescriptions until the problems have been addressed and another audit indicates that the system meets the requirements of part 1311. Section 1311.175 would specify the pharmacy's responsibility not to dispense controlled substances in response to an electronic prescription if the pharmacy's system does not meet the requirements of part 1311. In addition, the pharmacy must not dispense a controlled substance if the DEA registration of the prescriber was not valid at the time of signing. Finally, the section would state that nothing in part 1311 relieves a pharmacy of its corresponding responsibility to dispense only in response to a prescription written for a legitimate medical purpose by a prescribing practitioner acting in the usual course of professional practice. Section 1311.180 would specify recordkeeping requirements for records required by part 1311. XI. Digitally Signed Prescriptions for Federal Health Care Agencies Federal healthcare providers have indicated that the electronic prescription option described above is not consistent with the electronic prescription system they currently use, a system that is based on public key infrastructure and digital signature technology. They also stated that the proposed rule described above did not meet their security needs. Thus, these Federal health care providers indicated that their existing system based on public key infrastructure and digital signature technology is more secure than, and incompatible with, the above system requirements that DEA is proposing. As a result, if they were obligated to adhere to the above system requirements, they would have to abandon their existing systems in favor of a less secure system, and would have to incur substantial cost and devote significant time to do so. Such a result would plainly be counterproductive. For these reasons, DEA is proposing—for Federal health care systems only—a second approach that is consistent with their current systems. Federal health care systems will also have the option of using the above system that will be allowable for all practitioners in the private sector. The two systems have some elements in common—for example, the pharmacy requirements are almost identical—but the digital signature option adds some steps and removes others as compared with the electronic prescription system. *Public Key Infrastructure and Digital Signatures* . Digital signatures are created as part of a public key infrastructure (PKI). In a PKI system, a certification authority

(CA)verifies the identity of an applicant and issues a digital certificate to the applicant. A Certification Authority operates under a publicly available Certificate Policy, a set of rules that covers subjects such as obligations of the Certification Authority, obligations of certificate holders, enrollment and renewal procedures, operational requirements, security procedures, and administration. 30 A digital certificate is a data record that contains, at a minimum, the identity of the issuing Certification Authority, identity information for the certificate holder, the public key that corresponds to the certificate holder's private key, validity dates, and a serial number. The certificate is digitally signed by the CA. The certification authority provides the subscriber with the means to generate an asymmetric pair of cryptographic keys. The subscriber retains control of the private key; the public key is available to anyone. What one of the keys encrypts, only the other key can decrypt. 30 National Institute of Standards and Technology. Special Publication 800-32 *Introduction to Public Key Technology and the Federal PKI Infrastructure; February 26, 2001. http://csrc.nist.gov/publications/nistpubs/800-32/sp800-32.pdf* . When a person digitally signs a record, the text of the record is run through an algorithm that produces a fixed-length digest (known as the hash). The private key is used to encrypt the digest. The encrypted digest is the digital signature. When the record is archived or sent to someone else, both the plain text and the digital signature are sent along with the signer's digital certificate, which includes the public key. If the recipient wants to confirm that the record has not been altered during transmission, the recipient can use the public key to decrypt the digest. This step confirms who sent the message (i.e., no one other than the holder of the private key could have sent the message and the holder cannot repudiate the message). The recipient's system can run the plain text received through the same hashing algorithm. If the two digests match, the recipient knows that the message sent has not been altered. For an in-depth explanation of digital signatures, see NIST FIPS 186-2. Discussion of Proposed Requirements for Digitally Signed Prescriptions *Certification Authorities and Digital Certificates* . Because this alternative applies only to Federal agencies, DEA is proposing that the Certification Authority will be one that is operated under the Federal PKI Bridge Certificate Policy and is either a Federal Certification Authority or cross-certified with a Federal CA. Digital certificates are already an option for Federal employees as part of the Personal Identification Verification

(PIV)cards (usually a smart card). DEA, therefore, is proposing that a PIV or other Federal identity card to be used for signing controlled substance prescriptions include a digital certificate. Federal identity proofing and the smart card with a digital certificate already meet Assurance Level 4, so no further requirements are needed. PIV cards include both the holder's photograph and a biometric. As with the proposed electronically signed prescription system, the system provider (the Federal agency) would be required to set access controls, set lock-out times at 2 minutes, require the practitioner to indicate which prescriptions he is authorizing when signing multiple controlled substance prescriptions at one time, provide screens showing the prescription information, and show the warning screen prior to signing. The system would be required to have the practitioner authenticate to the system just prior to signing. The system provider would also be required to check the CA's certificate revocation list

(CRL)prior to transmission to ensure that the certificate is still valid. The CRL may be cached until a new CRL is issued. DEA is proposing that any software system may be used to sign electronic controlled substances prescriptions provided that it has been enabled to process digital signatures and that the PKI module meets the following requirements: 1. The encryption module must comply with FIPS 140-2. 2. The digital signature generation system must comply with FIPS 186-2. 3. The secure hash algorithm must comply with FIPS 180-1. 4. For software implementations, when the signing module is deactivated, the system must clear the plain text password from the system memory to prevent the unauthorized access to, or use of, the private key. 5. The system must have a time system that is within five minutes of the official National Institute of Standards and Technology

(NIST)time source. Item four would ensure that the password cannot be retrieved from the certificate holder's computer memory following its use. Software systems may not automatically clear items from memory when the application is shut down. Therefore, it is necessary to specify that the system clear the password from the system's memory whenever the signing application is closed to ensure that someone cannot recover the password. Item five requires the system to have a time system within five minutes of the official National Institute of Standards and Technology time source. It is important that all users of digitally signed electronic prescriptions be synchronized to a single, consistent time source. Once the prescription record is digitally signed, both the record and the digital signature must be archived. DEA is proposing that the system provider would be able to adopt one of two options for transmission after signing. The system provider could require transmission immediately on digitally signing or the system provider could “lock” and archive the prescription as digitally signed and allow other elements (e.g., pharmacy URL) to be added later. The “lock” would have to ensure that any element that was digitally signed could not be altered prior to transmission. For example, the system provider could program its system so that only the DEA-required elements would be digitally signed and only those elements and their digitally signed version are archived. Unlike the electronically signed prescription approach, the system provider would not be required to apply its own digital signature to the record received from the prescribing practitioner. Because digital certificates from a Federal CA and digital signatures provide a level of security and record integrity that electronically signed prescriptions do not have, DEA is not proposing that a monthly log be generated and checked for digitally signed prescriptions. When prescriptions are transmitted to retail pharmacies, they are frequently reformatted, making it impossible to validate a digitally signed prescription. DEA is not, therefore, proposing that the digital signature be transmitted with the prescription. This provision should eliminate the concern that intermediaries had about the difficulty of transmitting the digital signature. The pharmacy would be required to digitally sign the record as received and archive it, as with electronically signed prescriptions. Where a prescription is sent to a Federal pharmacy, however, the Federal agency may elect to transmit the digital signature and have the pharmacy validate the prescription. In that case, the Federal pharmacy would not be required to digitally sign the prescription. The other pharmacy requirements would be the same as for electronically signed prescriptions. The pharmacy would be required to check the DEA registration and maintain internal audit trails with daily computer checks for auditable events. DEA is also proposing that Federal agencies using digital signatures would have to have an annual third-party audit of their system processing integrity to ensure that the systems meet DEA's requirements. Prescribing practitioners' use of digital certificates from a Federal or cross-certified CA would make insider identity theft much more difficult, eliminating the need to require the audit to review system security as is the case for the electronically signed prescription systems. The practitioner would be required to notify the CA if the hard token was lost, stolen, or compromised within 12 hours of discovery of the loss, theft, or compromise. The CA would be required to revoke the certificate upon notification. These requirements are already met by the Federal systems. Section-By-Section Discussion of the Proposed Rule for Digitally Signed Controlled Substances Prescriptions for Federal Health Care Agencies In Part 1311, as proposed to be amended as discussed above, DEA is proposing to add a new Subpart D regarding requirements for electronic prescriptions for controlled substances for Federal health care agencies. Section 1311.200 would state that a practitioner prescribing controlled substances at a Federal health care facility in the course of their official duties may issue a controlled substance prescription electronically if the practitioner is registered as an individual practitioner, or exempt from the requirement of registration, and is authorized under the registration or exemption to dispense the controlled substance, and the practitioner uses an electronic prescription system that meets all of the applicable requirements of the subpart. DEA would propose to define “Federal health care facility” as a hospital or other institution that is operated by an agency of the United States (including the U.S. Army, Navy, Marine Corps, Air Force, Coast Guard, Department of Veterans Affairs, Public Health Service, or Bureau of Prisons). An electronic prescription for controlled substances issued through a system that did not meet the requirements of part 1311 would not be considered valid. The section would reiterate the requirement from § 1306.05 that the practitioner is responsible if the prescription does not conform in all essential respects to the CSA and implementing regulations. Section 1311.205 would establish requirements for issuance and storage of digital certificates. It would require that only Federal Certification Authorities or Certification Authorities cross-certified with a Certification Authority operated by the Federal Public Key Infrastructure Policy Authority may issue digital certificates to practitioners prescribing controlled substances at a Federal health care facility in the course of their official duties to sign electronic controlled substance prescriptions. The digital certificate must be stored on a hardware token that meets the requirements of NIST SP 800-63 Level 4. Section 1311.210 would state the system requirements for digitally signed prescriptions. Any system may be used to digitally sign electronic prescriptions for controlled substances provided that the system has been enabled to accept digitally signed documents and that it meets the requirements discussed above. DEA would require the system to use two-factor authentication that meets the requirements of NIST SP 800-63, Level 4 as discussed above. The practitioner must reauthenticate to the system if the system is inactive for more than 2 minutes. Section 1311.215 would require that a digitally signed electronic prescription for a controlled substance created by the system must include all of the data elements required under part 1306. Section 1311.220 would set the requirements for creating an electronic prescription. Consistent with current regulations governing paper prescriptions, DEA is proposing that the electronic prescribing system may allow the registrant or his agent to enter data for a controlled substance prescription, but only the registrant may sign and authorize the prescription. The system must display information regarding the prescriptions including: The patient's name and address; the name of the drug being prescribed; the dosage strength and form, quantity, and directions for use; and the DEA registration number under which the prescription will be authorized. Finally, the section would require that, where more than one controlled substance prescription has been prepared, the practitioner positively indicate that he has reviewed and approved the information for each prescription prior to signing and authorizing electronic transmission of the prescriptions. Section 1311.225 would set the requirements for signing an electronic prescription. The practitioner must authenticate to the system using two-factor authentication. This would include the practitioner's declaration that information contained in the record constitutes the practitioner's legal authorization and signature. DEA would require the system to check the certificate revocation list of the Certification Authority that issued the digital certificate of the practitioner who digitally signed the controlled substance prescription. If the certificate is not valid, the system would not be permitted to transmit the prescription. DEA would permit the certificate revocation list to be cached until the Certification Authority issues a new certificate revocation list. If the prescription is being transmitted to a pharmacy that does not accept digitally signed prescriptions, DEA would require the system to include in the data file transmitted an indication that the prescription was signed by the issuing practitioner. Section 1311.230 would disallow the printing of an electronically transmitted prescription and would also disallow the electronic transmission of a printed prescription as discussed above. These requirements are to prevent an individual electronic prescription from being transmitted more than once to a pharmacy (or pharmacies). The system would be required to retain the archived digitally signed prescription for five years from the date of issuance by the practitioner. Finally, the section would specify that the DEA required contents of the prescription could not be altered after signature without rendering the prescription invalid. The contents could be reformatted; reformatting includes altering the structure of fields or machine language so that the receiving pharmacy system can read the prescription and import the data into the system. Section 1311.235 would set the requirements for revocation of access authorization. The system would be required to revoke access to sign controlled substance prescriptions on the expiration date of the practitioner's DEA registration, if applicable, unless the Federal agency determines that the registration or Federal agency authorization has been renewed. The system would be required to check the DEA CSA database at least once a week and revoke access to signing controlled substance prescriptions for any practitioner using the system whose registration or Federal agency authorization has been terminated, revoked, or suspended. Section 1311.245 would require the Federal agency to notify DEA of certain security incidents, including: • An individual who is not a DEA registrant authorized by the Federal agency to prescribe controlled substances in the course of their official duties at the Federal agency has been granted access to issue controlled substance prescriptions. • Access to issue controlled substance prescriptions has been granted to a person using another person's identity. • Prescription records have been created or altered by an employee not authorized to create or annotate a controlled substance record. • There have been one or more successful attempts to penetrate the system from the outside. • The Federal agency has identified any other incident that may indicate that the integrity of the system in regard to controlled substance prescriptions has been compromised. Section 1311.250 would require the Federal agency to have a third-party audit to verify that the system used to create and transmit controlled substance prescriptions meets the requirements of this subpart prior to accepting any controlled substances prescriptions for transmission and annually thereafter. If the third-party audit finds that the system does not meet one or more of the requirements of the part, the system must not accept for transmission any controlled substance prescription. The Federal agency must also notify the Administration of the adverse audit report and provide the report to the Administration. Section 1311.255 would specify the practitioner's responsibilities as discussed above. The practitioner would be required to maintain sole possession of the hard token and notify the Certification Authority no later than 12 hours after the discovery of its loss or theft or any indication that the hard token had been compromised. The section would reiterate that the practitioner has the same responsibility for the validity of an electronic prescription as the practitioner does for a paper prescription. Section 1311.260 would require that if a pharmacy receives a controlled substance prescription from a Federal agency system that is not transmitted with its digital signature, either the pharmacy must digitally sign the prescription immediately upon receipt, or the last intermediary transmitting the record to the pharmacy must digitally sign the prescription immediately prior to transmission and transmit to the pharmacy the prescription and the digitally signed record. The pharmacy must archive the record as received and the digitally signed copy. If a Federal pharmacy receives a digitally signed prescription that includes the digital signature, the pharmacy must validate the prescription and archive the digitally signed record. The pharmacy record must retain an indication that the prescription was validated upon receipt. No additional digital signature is required. Section 1311.265 would require the pharmacy to check the validity of the DEA registration prior to dispensing the prescription. The pharmacy system must reject a controlled substance prescription if it is not signed or is otherwise not valid. The pharmacy system would have to be able to include all of the information required under part 1306 in the electronic record and be capable of downloading the records in a readable and sortable format, as well as printing the records, if requested. Section 1311.270 would specify the security requirements for the pharmacy system including a backup storage system at another location, maintaining an internal audit trail, the implementation of a list of auditable events, a daily internal audit to identify if any auditable events have occurred, reporting any security incidents that could affect the integrity of the prescription records, and the annual third-party audit to ensure compliance with the requirements of this part. Audits must be conducted prior to accepting any controlled substances prescriptions for processing and annually thereafter. If the audit finds that the system does not meet the requirements of the part, the system must not process controlled substance prescriptions until the problems have been addressed and another audit indicates that the system meets the requirements of part 1311. The Federal agency must also notify the Administration of the adverse audit report and provide the report to the Administration. Section 1311.275 would specify the pharmacy's responsibility not to dispense controlled substances in response to an electronic prescription if the pharmacy's system does not meet the requirements of part 1311. In addition, the pharmacy must not dispense a controlled substance if the DEA registration of the prescriber was not valid at the time of signing. Finally, the section would state that nothing in part 1311 relieves a pharmacy of its corresponding responsibility to dispense only in response to a prescription written for a legitimate medical purpose by a prescribing practitioner acting in the usual course of professional practice. Section 1311.280 would specify recordkeeping requirements for records required by Subpart D of part 1311. XII. Incorporation by Reference The following standard is proposed to be incorporated by reference: NIST SP 800-63, Electronic Authentication Guideline, April 2006. XIII. Required Analyses Executive Order 12866 Under Executive Order 12866 (58 FR 51735, October 4, 1993), DEA must determine whether a regulatory action is “significant” and, therefore, subject to Office of Management and Budget review and the requirements of the Executive Order. The Order defines “significant regulatory action” as one that is likely to result in a rule that may:

(1)Have an annual effect on the economy of $100 million or more or adversely affect in a material way the economy, a sector of the economy, productivity, competition, jobs, the environment, public health or safety, or State, local, or tribal government or communities.

(2)Create a serious inconsistency or otherwise interfere with an action taken or planned by another agency.

(3)Materially alter the budgetary impact of entitlements, grants, user fees, or loan programs or the rights and obligations of recipients thereof.

(4)Raise novel legal or policy issues arising out of legal mandates, the President's priorities, or the principles set forth in the Executive Order. A copy of the *Initial Economic Impact Analysis of the Electronic Prescriptions for Controlled Substances Rule* can be obtained by contacting the Liaison and Policy Section, Office of Diversion Control, Drug Enforcement Administration, 8701 Morrissette Drive, Springfield, VA 22152, Telephone

(202)307-7297. The initial analysis is also available on DEA's Diversion Control Program Web site at *http://www.deadiversion.usdoj.gov* . DEA seeks comments on the assumptions used in the economic analysis and is interested in any data that commenters can provide on the time required to comply with the proposed rule. It has been determined that this Notice of Proposed Rulemaking is an economically significant regulatory action; therefore, DEA has conducted an analysis of the options. The following sections summarize the economic analysis conducted in support of this proposed rule. Options Considered DEA considered four options for the electronic prescribing of controlled substances: the rule as proposed with service providers conducting the identity proofing (Base Case); the rule as proposed (Option 1); a modified PKI option (not limited to Federal agencies) (Option 2); and an option that allowed the use of any existing electronic system with no additional requirements except callbacks from the pharmacy to the practitioner to verify the authenticity and integrity for all controlled substance prescriptions (Option 3). Table 7 shows the differing requirements for the rule elements for each of the options. Table 7.—Options Considered Requirement Base case Option 1 Option 2 Option 3 Identity Proofing Conducted by service provider Conducted by hospital, state board, law enforcement Conducted by hospital, state board, law enforcement N/A. Two-factor, Hard token Required Required Required N/A. Authentication protocol Issued by service provider Issued by service provider Digital certificate from CA N/A. System requirements Required Required Required N/A. Digitally signed record System level System level Practitioner N/A. Pharmacy Digitally sign record on receipt Digitally sign record on receipt Validate practitioner digital signature Call practitioner to confirm each prescription. Internal Audits Required Required Required N/A. Third-party audits SysTrust/SAS 70 security and processing SysTrust/SAS 70 security and processing Processing integrity N/A. Universe of Affected Entities The entities that are most directly affected economically by the adoption of electronic prescriptions for controlled substances fall into two groups—practitioners who sign prescriptions and the firms that provide the computer and Internet software and services required for the creation, transmission, and receipt of electronic prescriptions. These firms serve either practitioners' offices or pharmacies. The affected universe does not include pharmacies directly, because the rule does not require any change in their operating practices; although their computer systems may need to be updated, the additional prescription processing steps (primarily digitally signing the record on receipt) will be handled by the system, not the pharmacist. For options 1 and 2, DEA-registered hospitals or other officials allowed to conduct identity proofing would also be affected. The registered practitioners are primarily physicians, dentists, and mid-level practitioners (physician's assistants and nurse practitioners). Most other practitioner registrants are less likely to prescribe as opposed to administer or dispense controlled substances (e.g., veterinarians). As discussed above, the service providers are vendors of the computer software and Internet services required by practitioners' offices for electronic creation and transmission of prescriptions and of the services required by pharmacies for receiving and processing electronic prescriptions. Many service providers to practitioners are application service providers (ASPs). Some of the service providers to pharmacies are ASPs, but most are not. Table 8 displays data on current numbers of practitioners and estimated future growth rates. Table 8.—Practitioner Universe Affected Universe—Practitioners Current No. Future annual growth rate (percent) Physicians 312,759 0.1 Dentists 170,969 0.5 Mid-levels 89,744 2.2 Total 573,472 0.5 The number of physicians is based on CDC data on the number of physicians in office-based practices. Current numbers for dentists and mid-level practitioners are DEA registrants as of December 3, 2007, with two modifications. The number of mid-level practitioners reported in this count includes, in addition to physician's assistants and nurse practitioners, workers in other health occupations who rarely sign prescriptions and who, therefore, have not been included. In addition, because many mid-level practitioners work at hospitals, the total was reduced by 25 percent because these practitioners may not write prescriptions. Estimated growth rates are based on recent trends. Regarding physicians, the trend since 2000 indicates a very slight negative growth rate. DEA does not believe this downward trend will continue; therefore, an annual growth rate for physicians of 0.1 percent has been estimated. The rate for the total number is the weighted average of the separate rates. While the current count of systems certified by SureScripts or CCHIT (or both) for practitioners is 119, DEA has adjusted that figure downward to 110 for Year 1 of the analysis. With 119 firms offering these services and products to practitioners, it seems certain that some of them are in a marginal business condition with respect to this market. Consequently, DEA projects a steady diminution over time in the number of firms. It also seems reasonable to assume that some of them will withdraw from the market at the outset. There are three reasons for this result. First, the market has already seen firms leave the market as the demand for the products has not met expectations. Second, the security arrangements at some firms may be insufficient to withstand the required security audit, and, for a number of reasons, some of these firms may be unwilling or unable to remedy this defect. Third, some firms may not want to incur the reprogramming costs necessary to include electronic prescriptions for controlled substances capability in their service, and it is highly unlikely that a firm would try to stay in the market without controlled substances capability, as that would place it at a severe competitive disadvantage. A relevant point here is that most current firms offer electronic health records (EHRs), with electronic prescription functionality as part of the EHR; the reprogramming costs may be much higher for firms that support only electronic prescriptions—just under $150,000 compared to a little under $40,000 for firms with EHR capability. To gain certification from CCHIT, EHR products must already include many of the security functions DEA is specifying in the proposed rule. Of the 119 vendors now in the market, 103 are EHRs. Those that are not EHRs are clearly more likely to be deterred by cost. DEA assumes that six of the electronic prescription-only vendors will withdraw from the market rather than add electronic controlled substances prescribing capability, while three of those that support EHR will also withdraw. Table 9 presents the service provider universe. Table 9.—Service Provider Universe Affected Universe—Service Providers Current No. Projection Service providers to practitioners 119 Adjusted to 110 The number of firms is expected to diminish over time, stabilizing at 20 vendors after ten years. Vendors to pharmacies (some are ASPs, most are not) 20 Provision of computer and Internet services to pharmacies is already a mature market segment; the number is not expected to change. Unit Costs In estimating unit costs of the rule, the first step is to establish the baseline with which to determine the costs that are incremental with respect to the rule. DEA presumes that no practitioner's office will adopt electronic prescribing simply to write controlled substance prescriptions; controlled substance prescriptions constitute about 11 percent of the total number of prescriptions. The costs to a practitioner's office of complying with the rule, therefore, are only the costs directly required by the electronic prescriptions for controlled substances rule and do not include any of the costs that the office would incur for setting up electronic prescription capability without electronic prescribing of controlled substances. Requirements • In-person identity proofing (§ 1311.105) imposes costs on practitioners, the institutions that conduct the identity proofing, and service providers (filing the information submitted and confirming the application). • Two-factor authentication (§ 1311.110) requires that each practitioner with authority to sign controlled substance prescriptions has a unique hard token to gain access to the system. This imposes costs on some practitioners who do not already have a token (e.g., a PDA). • Monthly review of controlled substance prescription logs (§ 1311.140) by practitioners imposes a cost on practitioners. (Applies only to Base Case and Option 1) • System requirements (§§ 1311.110-1311.145) imposes reprogramming costs on service providers. • Requirements (§ 1311.150) for annual third-party audits imposes costs on service providers. Costs *Identity proofing.* Identity proofing requires a face-to-face meeting between each practitioner who will use the system and either the service provider (Base Case) or a person from a DEA-registered hospital or other official (Options 1 and 2). For the Base Case, DEA assumes that the practitioner and service provider would spend 2 minutes each at the practice; the service provider would spend another 8 minutes at its offices checking the State license and DEA registration and filing the information gathered. Because most physicians have privileges at hospitals, DEA assumes that for Option 1 and 2 identity proofing would take only 10 minutes for physicians. All other practitioners are assumes to need an hour to travel to and from a hospital or police station plus the 10 minutes for the proofing. Each practitioner would also spend another 1 minute verifying the application when called by the provider. For each practitioner, the hospital staff are assumes to spend 10 minutes checking the identity documents and completing the form. The service provider will spend another 11 minutes at the service provider's office verifying State license and DEA registration information, entering the practitioner's data into the service provider's record of identity proofing, and calling the practitioner to verify. These costs are the same for Options 1 and 2, although under Option 2 the cross-signed identity proofing document would be sent to the Certification Authority. *Two-factor authentication.* Two-factor authentication requires that access to the system can be gained only with a hard token, uniquely coded for each practitioner. A number of devices will serve for this purpose: *e.g.* , PDAs, Blackberries, thumb drives, multi-factor one-time-use password tokens. It is assumes that physicians and dentists will already have one of these devices and be familiar with its use. The same cannot be assumed for mid-level practitioners. DEA assumes that tokens will have to be purchased for 75.0 percent of mid-level practitioners and those mid-level practitioners will require training in the use of the tokens. DEA assumes that the tokens will be thumb drives. Time required for training is estimated to be ten minutes per mid-level practitioner. Using the hourly wages (including fringes and overhead) for physician's assistants for $77, the training cost is estimated to be $12.82. A thumb drive costs $12.00. One-time-password tokens may be more or less expensive; some of these can be installed on cell phones, which any practitioner would have. *Digital Certificate.* Under Option 2, practitioners would be required to obtain a digital certificate from a certification authority cross-certified with a Federal Certification Authority. The annual cost of digital certificates varies from CA to CA depending on the security characteristics. DEA assumes an annual cost of $30. *Monthly review of controlled substance prescription logs.* Under the Base Case and Option 1, once a month, each practitioner must review a log of his controlled substance prescriptions for that month. As discussed above, DEA is not proposing to require a comprehensive review. DEA estimates that a practitioner can review the log for unusual controlled substance prescriptions in an average of two minutes. DEA recognizes that there will be a considerable range in review time based on the number of controlled substance prescriptions a practitioner writes. The average cost is estimated to be $89 per year, using a weighted hourly wage for all practitioners. *Reprogramming requirements.* Under the Base Case, Option 1, and Option 2, all service providers, including those that serve pharmacies, will have to do some reprogramming to add electronic controlled substance prescription-required functions to their systems. Depending on the functionalities of their existing systems, they will need more or less reprogramming. Two requirements in particular will necessitate some reprogramming for almost all systems that serve practitioners. These are the provision that the first recipient system digitally sign and archive the controlled substance prescription on receipt and that the system will transmit from a practitioner's office immediately following the practitioner's signature with the hard token. (At least one service provider already digitally signs prescriptions, and more than one transmit the prescription immediately upon signature.) The requirement for a screen indicating that the prescriber understands that the prescription is being signed will also be new for systems. Other requirements will affect only some providers. Limiting access to signing to practitioners may require reprogramming of some systems, though this functionality is generally part of systems. The need to show all of the selected prescription information on a single screen may require new programming for a few systems. For some stand-alone systems, the requirements for two-factor authentication at Level 4 will require reprogramming as will requirements for reauthentication after a period of inactivity. As shown in the table of requirements in Section IX above, most EHRs already support these functions. Consequently, the reprogramming required for EHR systems will be less than for stand-alone systems. Systems that serve pharmacies will also require some reprogramming, primarily for digitally signing the record as received. Those pharmacy systems that operate as ASPs should already have digital signature capability; others may need to do additional programming to add that functionality. Both will need to add programming to sign the record. The industry has indicated that the requirements for internal audit trails and internal audit analysis are part of existing systems. DEA has estimated that EHR systems and pharmacy ASP systems will require an additional 500 hours to program and test the new functions. For stand-alone electronic prescription systems and installed pharmacy systems, DEA estimates that they will spend 2,000 hours to program and test the new functions. Using the hourly wage rate for programmers of $73 (loaded), the initial programming cost will be $36,700 for EHR and pharmacy ASP systems and $146,500 for stand-alone systems and installed pharmacy systems. *Auditing requirements.* Under the Base Case, Option 1, and Option 2, all system providers that serve practitioners and those that serve pharmacies must undergo an annual third-party audit. Under the Base Case and Option 1, the audit would have to meet the requirements for a SysTrust, WebTrust, or SAS 70 audit for security and processing integrity. The first such audit for a service provider is generally more costly than subsequent audits. DEA estimates the following per-vendor costs for audits: First-year audits: $125,000; Subsequent audits: $100,000. Under Option 2, the audit would need to address only processing integrity ( *i.e.* , that the system reliably meets DEA's requirements). Because of the limited scope of this audit, it could be conducted by a broader range of auditors; DEA estimates an annual cost of $25,000. DEA notes that the costs of a SysTrust or SAS 70 audit range from $15,000 to $250,000 depending on the size of the company. DEA used a conservative estimate of $125,000 for the initial audit although in many cases the cost for the DEA required audit elements would be less. A full SysTrust or SAS 70 audit covers five areas; DEA is requiring that the audit address only two of those, physical security and processing integrity. *Callbacks.* For Option 3, the only cost of electronic prescriptions for controlled substances would be the callback from the pharmacy to the practitioner to confirm the prescription. DEA estimates that this would take 3 minutes of staff time at the practitioner's office to pull the file and refile it, 1 minute of the practitioner's time, and 3 minutes of a pharmacy technician's time; the total cost per call would be $6.55. Table 10 summarizes unit costs. Table 10.—Unit Costs Requirement Unit time Wage rate Unit cost Identity Proofing Practitioner

(Base)2 minutes $222.51 $7.42 Service Provider

(Base)2 minutes 83.80 2.79 Service Provider clerk

(Base)8 minutes 33.89 4.52 Service Provider 10 minutes 33.89 5.65 Storage at service provider 0.01 Service Provider

(1)13 minutes 33.89 5.35 Practitioner (1 & 2): MDs 11 minutes 269.00 49.32 Dentists 11 minutes 214.07 39.25 Mid-level practitioners 11 minutes 76.94 14.11 Practitioner travel time: Dentists 1 hour 214.07 214.07 Mid-level practitioners 1 hour 76.94 76.94 Hospital 10 minutes 35.55 5.93 Mailing time 2 minutes 30.33 1.01 Mailing cost 0.41 Total—MDs (1 & 2) 62.32 Total—Dentists (1 & 2) 266.31 Total—Mid level practitioners (1 & 2) 104.05 2-Factor Token Learning time 10 minutes 76.94 12.82 Token 12 Digital Certificate 30/year Log review 24 minutes/year 222.51 89.01 Programming EHR/Pharmacy ASP 500 hours 73 36,623 Other systems 2,000 hours 73 146,490 Third-Party Audit (Base, 1) 125,000 (first year) 100,000 (following) Third-Party Audit

(2)25,000 per year Option 3: Callback 1 minute practitioner 3 minutes med. staff 3 minutes pharmacy tech 222.51 30.60 26.23 6.55 Total costs To estimate total costs, it is first necessary to establish the distribution of costs over time. The costs to be considered in the analysis may be divided into start-up costs and ongoing costs. For a practitioner's office, the start-up costs are incurred in the year in which the office implements electronic prescribing of controlled substances, and the ongoing costs are incurred in every year thereafter. For service providers, all the start-up costs are incurred in Year 1 of the analysis. DEA presumes that all service providers will add controlled substance electronic prescribing capability to their systems in the first year, lest they be placed at a competitive disadvantage. But this will not be the case for practitioners' offices. They will implement electronic prescribing of controlled substances over time as they implement electronic prescriptions and EHRs. DEA has projected complete implementation of electronic prescribing of controlled substances over a 15-year period; i.e., at the end of the 15th year of the analysis, all practitioners' offices will have controlled substance electronic prescribing capability in their electronic prescription systems. This is essentially an estimate of the rate of electronic prescription implementation. As practitioners adopt electronic prescription capabilities, they will include electronic prescribing of controlled substances in the package, as the incremental cost of doing so for an office is very slight. DEA notes that although the selection of the implementation period is somewhat arbitrary, DEA believes that 15 years is a reasonable estimate to reflect the balance between pressure from insurers, who want practitioners to implement EHR systems, and the reluctance of practitioners to invest in expensive systems that are time-consuming to implement and perhaps not yet fully tested. Table 11 shows the schedule at which DEA projects implementation over time. Table 11.—Implementation Schedule Percentage of offices implementing in a year Cumulative implementation percentage Year 1 6.0 6.0 Year 2 4.0 10.0 Year 3 4.0 14.0 Year 4 5.0 19.0 Year 5 5.0 24.0 Year 6 5.0 29.0 Year 7 6.0 35.0 Year 8 6.0 41.0 Year 9 7.0 48.0 Year 10 9.0 57.0 Year 11 10.0 67.0 Year 12 11.0 78.0 Year 13 11.0 89.0 Year 14 6.0 95.0 Year 15 5.0 100.0 The rate in Year 1 is somewhat higher than the rate in the next several years, because about 6 percent of offices have already adopted electronic prescription systems. After dropping in Year 2, the rate rises gradually to a peak in Years 12 and 13 and then drops as full implementation approaches. This is based on the observation that adoption of electronic prescribing has been slow to date and that many practitioners are very reluctant to accept changes in the basic methods with which they conduct their practices, especially the direct introduction of computer-based systems into their own work. The start-up costs incurred by practitioners' offices in each year will be based on the number of practitioners in offices implementing controlled substances electronic prescribing capabilities in that year. Ongoing costs for practitioners will be based on the total number of practitioners in offices where electronic prescribing of controlled substances has been implemented in a given year, i.e., the cumulative percentage of practitioners in offices that have adopted electronic prescribing of controlled substances. Both start-up costs and ongoing costs will also reflect the annual growth rates of the different classes of practitioners—0.1 percent for physicians, 0.5 percent for dentists, and 2.2 percent for mid-level practitioners. Start-up costs for practitioners are the initial identity proofing and the purchase of hard tokens, and training in their use, for some of the mid-level practitioners. The major ongoing cost under the Base Case and Option 1 is the monthly log review. But there is also some ongoing cost associated with turnover of personnel in practitioners' offices. When a practitioner moves to a new office, there is a high likelihood that the transfer will also be a move between system vendors; when that is the case, there must be a new identity proofing for that individual. Transfers of mid-level practitioners may require new purchases of hard tokens. Some further assumptions beyond implementation and growth rates must be made to estimate total costs for practitioners' offices and service providers. These are as follows: • For the Base Case, percentage of initial identity proofing visits by service provider staff where the travel to the office is needed only for the identity proofing: 15.0 percent. (Percentage of non-EHR systems). For ongoing identity proofing visits due to personnel turnover, there is no incremental travel. • Percentage of personnel transfers between offices that are also transfers between service providers: 90.0 percent. • Annual turnover rate for physicians and dentists: 2.5 percent. • Annual turnover rate for mid-level practitioners: 5.0 percent. As noted earlier, the service providers will incur all their start-up costs, apart from identity proofing, in Year 1 of the analysis. Aside from identity proofing, their ongoing costs will be the annual audits. The cost per service provider will remain the same over time, but the total cost will diminish as the number of service providers serving practitioners declines in an ongoing process of attrition due to over-population on the supply side of the market. Although this reduction may seem large, DEA notes that in the mid-1980s, there were about 400 word processing software systems; only a few remain. 31 The number of service providers serving pharmacies remains stable at 20 throughout the analysis period. Table 12 shows DEA's projection of the number of providers serving practitioners. 31 Bergin, T.J., “The Proliferation and Consolidation of Word Processing Software: 1985-1995.” *IEEE Annals of the History of Computing.* Volume 28, Issue 4, Oct.-Dec. 2006 Page(s):48-63. Table 12.—Projected Reduction in Electronic Prescription Service Providers Number of providers serving practitioners Year 1 110 Year 2 95 Year 3 80 Year 4 70 Year 5 60 Year 6 50 Year 7 40 Year 8 30 Year 9 25 Year 10 25 Year 11 20 Year 12 20 Year 13 20 Year 14 20 Year 15 20 The results of the unit costs and the foregoing assumptions about distribution of costs over time and other items are summarized in Tables 13 and 14, showing the annualized cost, over 15 years at a 7 percent and a 3 percent discount rate. Table 15 presents a summary of annualized costs for the four options. Table 13.—Annualized Cost per Option and Requirements [7% Discount rate] Practitioners Providers Total Base Case 7.0 percent Identity Proofing $352,367 $459,425 $811,792 Tokens 90,757 90,757 Training 75,147 75,147 Log reviews 22,495,039 22,495,039 Reprogramming 824,224 824,224 Audits 8,264,492 8,264,492 Total 32,561,452 Option 1 Identity Proofing 6,151,445 354,910 6,506,355 Tokens 90,757 90,757 Training 75,147 75,147 Log reviews 22,495,039 22,495,039 Reprogramming 824,224 824,224 Audits 8,264,492 8,264,492 Total 38,256,015 Option 2 Identity Proofing 6,151,445 354,910 6,506,355 Tokens 90,757 90,757 Training 75,147 75,147 Digital Certificates 7,582,154 7,582,154 Reprogramming 703,606 703,606 Audits 3,636,812 3,636,812 Total 18,594,831 Option 3 Callbacks 1,023,778,891 256,261,645 1,280,040,536 Table 14.—Annualized Cost per Option and Requirements [3% Discount rate] Practitioners Providers Total Base Case 3.0 percent Identity Proofing $357,789 $443,823 $801,612 Tokens 94,227 94,227 Training 76,832 76,832 Log reviews 24,389,580 24,389,580 Reprogramming 628,833 628,833 Audits 7,401,186 7,401,186 Total 33,392,270 Option 1 Identity Proofing 6,269,439 360,851 6,630,290 Tokens 94,227 94,227 Training 76,832 76,832 Log reviews 24,389,580 24,389,580 Reprogramming 628,833 628,833 Audits 7,401,186 7,401,186 Total 39,220,948 Option 2 Identity Proofing 6,269,439 360,851 6,630,290 Tokens 94,227 94,227 Training 76,832 76,832 Digital Certificates 8,220,726 8,220,726 Reprogramming 536,808 536,808 Audits 3,369,812 3,369,812 Total 18,928,003 Option 3 Callbacks 1,123,085,458 281,119,029 1,404,204,487 Table 15.—Total Annualized Costs 7.0 percent 3.0 percent Base Case $32,561,000 $33,392,000 Option 1 38,256,000 39,221,000 Option 2 18,595,000 18,928,000 Option 3 1,280,041,000 1,404,205,000 The two largest cost drivers for the Base Case are the monthly log review for practitioners and the annual audits for the service providers. The cost for practitioners almost disappears without the log review; with the 7.0 percent interest rate, it drops to under $1.0 million. The annual audits account for approximately $8 million of the cost to service providers at the 7.0 percent rate. For Options 1 and 2, identity proofing is a significant cost; these costs fall mainly on practitioners who do not routinely visit hospitals as part of their practices. For Option 2, digital certificates are also a significant cost, but audits are a lower cost. Option 3 is far more costly than any of the other options although it entails no upfront costs and imposes no costs on the service providers. Benefits The benefits often ascribed to electronic prescriptions are not directly attributable to this rule except to the extent the rule facilitates implementation of electronic prescribing. Electronic prescriptions may provide benefits to patients by reducing medication errors caused by illegible or misunderstood prescriptions. They may also reduce processing time at the pharmacy, callbacks to practitioners, and waiting time for patients. To estimate the part of these benefits that may accrue to the proposed rule, DEA estimated the number of controlled substance prescriptions that may require callbacks (approximately 27 percent of original prescriptions). Assuming that electronic controlled substance prescriptions phased in over 15 years, as described above, the annualized time-saving for eliminating these callbacks would be $316 million (at 7% discount) or $346 million (at 3% discount). Electronic prescriptions could also reduce the patient's wait time at the pharmacy. Assuming the average wait time is 15 minutes for the 81 percent of original prescriptions that are presented on paper to retail pharmacies (not mail order or long-term care prescriptions), at the current United States average hourly wage ($19.62), the annualized savings over 15 years would be $589 million (at 7% discount) or $646 million (at 3% discount). The estimates for public wait time are upper bounds. They assume that the practitioner will transmit the prescription and that the pharmacist will open the record and fill it before the patient arrives at the pharmacy. It is probably more realistic to assume that only a fraction of these benefits will be gained. There may also be some offsetting costs to the pharmacy. The industry estimates that about 20 percent of prescriptions written are never presented to pharmacies. If these are sent to pharmacies electronically and prepared before the patient arrives, the pharmacy will have spent time for which it will not be reimbursed if the patient does not pick up the prescription. (It may be reasonable to expect the 20 percent to decline with electronic prescriptions, although probably not to zero.) Table 16 presents the annualized benefits at a 7 percent and 3 percent discount rate. Table 16.—Annualized Benefits 7.0 percent 3.0 percent Callbacks Avoided $315,626,000 $346,242,000 Public Wait Time Avoided 588,732,000 645,839,000 The benefits, both of which represent time savings, clearly exceed by a wide margin the costs of the Base Case and Options 1 and 2. The costs of Option 3 at $1.3 to $1.4 billion a year exceed the benefits, which would not, of course, include callbacks eliminated. *Other Benefits.* DEA has not attempted to quantify any reduction in medical errors. Most of the studies on medication errors have been done in hospital settings; the studies of outpatient errors do not usually disaggregate the types of errors to distinguish those that could be prevented by accurate electronic prescriptions (e.g., misread illegible prescriptions versus a dispensing error such as inadvertently selecting the wrong drug or wrong strength); and none indicate what percentage of errors are related to controlled substances. In addition, although electronic prescriptions should eliminate illegibility issues, some of these mistakes may be replaced by keying errors. DEA expects that there will be reduced medication errors linked to more readable prescriptions, but decided that it did not have a reasonable basis for quantifying the benefits. Another benefit of electronic prescriptions for controlled substances that is ascribable to the proposed rule, but not easily quantified and monetized, would come from reductions in controlled substance prescription forgery and alteration. Prescription forgery, alteration, and misuse (e.g., faxing the same prescription to multiple pharmacies) is a part of the total illegal market for diversion of legal drugs. Diversion of legal medication for illegal consumption usually involves controlled substances. Diversion and abuse are significant social problems; the proposed rule is intended to help curb some of these illegal activities. As discussed above, diversion of prescription drugs through forgery, doctor shopping, and alteration of pharmacy records is a growing problem. Controlled substances are diverted in a number of ways, some of which will not be affected by electronic prescriptions. For example, diversion occurs when: • Drugs are stolen from practitioners and pharmacies. • Practitioners knowingly write nonlegitimate prescriptions. • Practitioners write prescriptions for people who have lied about symptoms to obtain the drugs. A commonly used term for these types of patients is “doctor shoppers,” people who routinely visit different doctors with the same ailment to obtain multiple prescriptions for controlled substances, usually pain relievers. These prescriptions are then filled at various pharmacies and the drugs are abused or sold on the illicit market. Although DEA does not expect this rule to eliminate these problems, it may act as a deterrent to practitioners who write nonlegitimate prescriptions and to doctor shoppers because it will be easier for States that have prescription monitoring programs to monitor prescriptions when they are electronic and because digitally signed prescriptions will make it very difficult for a practitioner to claim that a digitally signed prescription has been forged or altered. Some States are already using prescription monitoring programs to identify practitioners who prescribe unusual quantities of controlled substances and patients filling multiple prescriptions at different pharmacies. Electronic prescriptions for controlled substances will directly affect the following types of diversion: • Stealing prescription pads or printing them, and writing nonlegitimate prescriptions. • Altering a legitimate prescription to obtain a higher dose or more dosage units (e.g., changing a “10” to a “40”). • Phoning in nonlegitimate prescriptions late in the day when it is difficult for a pharmacy to complete a confirmation call to the practitioner's office. • Faxing a prescription to multiple pharmacies. • Altering a pharmacy record to cover the diversion of controlled substances. These are examples of prescription forgery that contribute significantly to the overall problem of drug diversion. DEA expects this rule to reduce significantly these types of forgeries because only practitioners with secure prescription-writing systems will be able to issue electronic prescriptions for controlled substances and because any alteration of the prescription at the pharmacy will be discernible from the audit log and a comparison of the digitally signed records. DEA expects that over time, as electronic prescribing becomes the norm, practitioners issuing paper prescriptions for controlled substances may find that their prescriptions are examined more closely. DEA is not aware of any comprehensive data on controlled substance prescription diversion in general, and forgeries in particular. DEA does not track information on prescription forgeries and alterations because enforcement is generally handled by State and local authorities. The cost of enforcement is, however, considerable. In 2007, DEA spent between $2,700 for a small case and $147,000 for a large diversion case just for the primary investigators; adjudication costs and support staff are additional. It is reasonable to assume that State and local law enforcement agencies are spending similar sums per case. As discussed above, some cases involve multiple jurisdictions, all of which bear costs for collecting data and deposing witnesses. The rule as proposed could reduce the number of cases and, therefore, reduce the costs to governments at all levels. A reduction in forgeries would also benefit practitioners who would be less likely to be at risk of being accused of diverting controlled substances and of then having to prove that they were not responsible. In contrast, a less secure electronic prescription system could greatly increase diversion and the number of forgeries and diversion cases and dramatically increase investigation costs if every provider and intermediary involved in a transaction had to provide testimony. A reduction in forged controlled substance prescriptions could also result in a reduction in drug addiction-related deaths, injuries, and crime. The 2006 NSDUH found that 6.7 million people in the United States currently use prescription-type therapeutic drugs for nonmedical reasons. SAMHSA reported that in 2003, in six States (Maine, Maryland, New Hampshire, New Mexico, Utah, and Vermont) there were 352 deaths from misuse of oxycodone and hydrocodone, both prescription controlled substances. 32 The 32 metropolitan areas that are part of the Drug Abuse Warning Network reported 3,530 deaths from misuse of oxycodone and hydrocodone and 1,381 deaths that involved the misuse of benzodiazepines in 2003. 33 In another report, SAMHSA stated that in 2004 there were 42,491 emergency room visits involving nonmedical use of hydrocodone, 36,559 visits for nonmedical use of oxycodone, and 144,000 visits for nonmedical use of benzodiazepines (Schedule IV). 34 By 2005, the number of emergency visits for nonmedical use of these drugs rose to 51,225 for hydrocodone, 42,810 for oxycodone, and 172,388 for the benzodiazepines. For all non-medical use of prescription opiates except methadone, the number of visits was about 155,000. 35 The costs of the deaths in the six States is more than $1 billion (at $3 million per life) and in the metropolitan areas more than $10 billion. The cost of the emergency room visits is above $300 million (at $1,000 per visit). A recent study of drug diversion and insurance fraud estimated that drug diversion costs health insurers $72 billion a year because of claims for fraudulent prescriptions and treating patients for the effects of drug abuse. 36 If the proposed rule prevents even a small fraction of these costs, the benefits will far exceed the implementation costs. 32 The New DAWN Report—Opiate-related Drug Misuse Deaths in Six States, 2003. Issue 19, 2006; *http://dawninfo.samhsa.gov/pubs/shortreports/* . 33 Substance Abuse and Mental Health Services Administration, Office of Applied Studies. *Drug Abuse Warning Network, 2003: Area Profiles of Drug-Related Mortality* . DAWN series D-27, DHHS Publication No.

(SMA)05-4023, Rockville, MD, March 2005; *http://dawninfo.samhsa.gov/pubs/mepubs/* . 34 Substance Abuse and Mental Health Services Administration, Office of Applied Studies. The DAWN Report—Emergency Department Visits Involving Nonmedical Use of Selected Pharmaceuticals. Issue 23, 2006; *http://dawninfo.samhsa.gov/pubs/shortreports/* . 35 Substance Abuse and Mental Health Services Administration, Office of Applied Studies. *Drug Abuse Warning Network, 2005: National Estimates of Drug-Related Emergency Department Visits* . DAWN Series D-29, DHHS Publication No.

(SMA)07-4256, Rockville, MD, March 2007; *http://dawninfo.samhsa.gov/pubs/edpubs/default.asp* . 36 Coalition Against Insurance Fraud, “Prescription for Peril: How Insurance Fraud Finances Theft and Abuse of Addictive Prescription Drugs,” December 2007. Regulatory Flexibility Act Under the Regulatory Flexibility Act of 1980 (5 U.S.C. 601-612) (RFA), Federal agencies must evaluate the impact of rules on small entities and consider less burdensome alternatives. DEA has conducted an initial Regulatory Flexibility Analysis and concluded that although the rule will affect a substantial number of small entities, it will not impose a significant economic impact on any regulated entities. The only entities regulated by DEA under this rule would be DEA registrants—prescribing practitioners and pharmacies. The service providers, although indirectly affected by the rule, are not registrants. Under the proposed rule, service providers may design and implement their systems and services in any way they choose. A DEA registrant, however, may not use a system that does not meet the requirements of the rule to create, transmit, receive, or process a controlled substance prescription. Nothing in this rule compels a DEA registrant to issue or process controlled substance prescriptions electronically. Practitioners may continue to issue controlled substances prescriptions on paper and, where permitted, by fax or telephone. Besides being only indirectly affected by the rule, the service providers are expected to recover their costs from registrants and others who purchase the software and systems. Characteristics of Small Entities As discussed in previous sections, the small entities directly affected by the proposed rule are practitioners and to a limited extent pharmacies. The firms marketing services and software are not directly affected by the rule because they will recover their costs from practitioners. Nonetheless, DEA will discuss the impact on these firms. Table 17 shows Small Business Administration's standards for these firms. Table 17.—SBA Definitions of Small Entities Affected entity Industry description NAICS code Small business definition (sales in $) Practitioner and Mid-Level Practitioner Offices of Physicians 62111 $9,000,000 Offices of Dentists 621210 6,500,000 Service Provider Software Publishing 511210 23,000,000 Pharmacy Pharmacies and Drug Stores 44611 6,500,000 Supermarkets and Other Grocery Stores 44511 25,000,000 General Merchandise Stores Mail Order Houses 45291 454113 25,000,000 23,000,000 Although some practitioners are part of large practices that may qualify as large businesses, so few practitioners fall into the large category that it is simpler to assume that they are all small entities. It is also the case that the service providers generally charge on a per practitioner basis rather than a per practice basis so that the costs may be considered as applying to individual practitioners. Mid-level practitioners are generally employed by a practice so their costs would be incurred by the practice, not the individual. They are not, therefore, small businesses. The lowest average net income for a physician in private practice listed in the Allied-Physician Survey is $135,000. 37 The American Dental Association states that the average net income of a dentist in private practice is $185,940 for a general practitioner. The average gross billings for a dentist in general practice per dentist is $595,340. 38 For pharmacies, the 17,500 independent pharmacies are small entities; the other pharmacies belong to about 200 chains that are mostly large firms. There may be a few chains with fewer than 3 pharmacies, which could be small. In 2006, National Association of Chain Drug Stores data indicate that the average independent pharmacy had prescription sales of $2.48 million a year; average total sales are about $2.675 million. 39 37 *http://www.allied-physicians.com/salary-surveys* , accessed 1/16/2008. 38 *http://www.ada.org/ada/prod/survey/faq.asp* , accessed 1/16/2008. 39 *http://www.nacds.org/wmspage.cfm?parm1=507* , accessed 1/18/2008. As discussed above, DEA estimates that there are about 130 service providers (110 for electronic prescriptions, 20 for pharmacies) that will be indirectly affected by this rule. A few of these are large entities or part of large companies (e.g., General Electric and McKesson). DEA has no information on the revenues of most of these firms. DEA notes that fully electronic EHRs cost between $20,000 and $50,000 per practitioner, with a usual monthly maintenance fee of $500 per practitioner. A provider, therefore, would need fewer than 4,000 practitioners to qualify as a large business. The providers of stand-alone electronic prescribing systems charge a tenth as much and are assumed to be small entities. Costs to Small Entities The costs to DEA registrants are relatively small. As noted above, the initial costs to the practitioner would range from about $62 to $266 for identity proofing, mostly for the time to have the identification checked. The main ongoing costs for the proposed rule would be the monthly log review by practitioners (about $89 a year) plus any incremental cost of the software or service. The initial and ongoing costs for the basic rule elements represent less than 0.2 percent of the annual income of the lowest paid practitioner. Determining the incremental cost of the system requirements per practitioner is difficult because it depends on the number of providers, the number of customers, the number of system requirements that a service provider does not already meet, and how costs are recovered (in the year in which the money is spent or over time). For example, an EHR system that had to reprogram to the full extent would have incremental system costs of $161,000 ($125,000 for the third-party audit and $37,000 for reprogramming). If the service provider had 1,000 practitioners enrolled in the first year, it would also incur about $5,660 for identity proofing. If the service provider recovered the costs ($167,000) from its 1,000 customers, the incremental cost to those customers would be $167 or about $14 a month. The costs in the out years would be lower because no further programming is needed and the audit cost is lower ($100,000). If the service provider added 1,000 practitioners a year over 15 years, the incremental cost per practitioner would fall as shown in Table 18. The costs shown are conservative because the audits may cost considerably less depending on the complexity of the system; many EHRs may need little reprogramming. Either or both of these factors in combination could reduce their costs considerably and, therefore, reduce the incremental costs to practitioners. Table 18.—Incremental Cost of EHR Systems to Practitioners Year No. Practitioners Total provider costs Annual cost/practitioner Monthly cost/ practitioner 1 1000 $167,70 $167.27 $13.94 2 2000 105,648 52.82 4.40 3 3000 105,648 35.22 2.93 4 4000 105,648 26.41 2.20 5 5000 105,648 21.13 1.76 6 6000 105,648 17.61 1.47 7 7000 105,648 15.09 1.26 8 8000 105,648 13.21 1.10 9 9000 105,648 11.74 0.98 10 10000 105,648 10.56 0.88 11 11000 105,648 9.60 0.80 12 12000 105,648 8.80 0.73 13 13000 105,648 8.13 0.68 14 14000 105,648 7.55 0.63 15 15000 105,648 7.04 0.59 In the first year, the total cost to a physician for DEA's requirements would be less than $300; dentists would have higher initial costs because of travel time. After that, the cost will decline over time to about $100 to $150 a year including the incremental costs charged for the systems. The lowest paid physician earns about $135,000 a year. For none of the registrants will the cost represent a significant economic impact. For pharmacies, the only costs will be the incremental cost that their service provider charges to cover the costs of reprogramming and audits. In the first year, if the service providers recover the programming costs in a single year, the average incremental cost to a pharmacy would be $85. After that, the incremental charge to recover the cost of the third-party audit would be $35 per pharmacy, assuming the cost is evenly distributed across all pharmacies. The first year charge represents 0.003 percent of an independent pharmacy's annual sales. It also represents a far lower cost than the pharmacy will pay SureScripts or another intermediary for processing the prescriptions. Currently, SureScripts charges the pharmacy $0.215 per electronic prescription to process and reformat prescriptions to ensure that the pharmacy system will be able to capture the data electronically. Based on National Association of Chain Drug Stores data on the average price of prescriptions ($68.26) and the average value of prescription sales, an independent pharmacy processes about 36,400 prescriptions a year and would have to pay SureScripts about $7,800. 40 40 *http://www.nacds.org/wmspage.cfm?parm1=507* , accessed 1/18/2008. Although these costs do not represent a significant economic impact, as discussed above, DEA considered options. The Base Case option would be less expensive initially, particularly for dentists and mid-level practitioners, because much less time would be needed for identity proofing. Once the identity proofing has occurred, however, the costs would be the same for the Base Case and Option 1. Option 2 would be less expensive for practitioners because the monthly log check would not be needed and the service provider costs would be lower because less stringent auditing requirements would be imposed. DEA has not proposed the Base Case because of two concerns about identity proofing. First, DEA is concerned that having a service provider employee checking the documents would make it easier for insider collusion to occur. Putting the in-person identity proofing in the hands of a DEA registrant or a public employee lessens that threat. Second, others expressed a concern that service providers would not visit practitioners' offices often, which could delay implementation and adoption, particularly for rural practices. DEA is not proposing the PKI option except for Federal health care agencies because of the concerns expressed by industry with regard to the use of digital signatures and the problems they would create for intermediaries. The third option, which would impose no costs on service providers, would be very expensive for pharmacies and practitioners. If the average independent pharmacy processes 36,400 prescriptions, about 11 percent of those are likely to be for controlled substances. Their annual cost for conducting callbacks on each of those would be about $5,200 in 2008; eliminating callbacks that already occur, the costs would be about $3,800 in 2008. If the number of controlled substance prescriptions (359 million original and newly authorized refills in 2008) were equally distributed among practitioners (about 573,000 in 2008), the average practitioner would incur costs of about $3,300 for callbacks under Option 3. Eliminating the callbacks that already occur, the average practitioner would incur new costs of about $2,200 under Option 3. DEA has, therefore, determined that the proposed rule would not impose a significant economic impact on a substantial number of small entities directly subject to the rule. Less expensive options are considered too burdensome by the service providers and intermediaries. The option that would impose no burden on service providers would impose substantially higher costs on practitioners and pharmacies. Another issue that DEA considered is whether the incremental costs might affect practitioners' decisions about purchasing a system that provides electronic prescribing. As discussed in previous sections of this preamble, the market for these systems has shifted away from stand-alone systems to EHRs. The cost of an EHR system for the functionalities that CCHIT requires ranges from $20,000 to $50,000 per practitioner with a usual annual maintenance charge of $6,000 per practitioner. (There are some less expensive systems marketed as EHRs that have only some of the functions; some appear to provide billing, scheduling, and simple records, but none of the more complex functions such as electronic prescribing, database links, etc.) Even in the first year, where the incremental cost of adding DEA's requirements would be between $150 and $200, this additional charge is unlikely to affect the decision to invest in an EHR, where the first year cost would be, at the low end $26,000 ($20,000 plus the $6,000 maintenance fee). The incremental costs would add less than 1 percent of the cost of the system; in the out-years, the incremental costs would similarly be a small fraction of the annual system maintenance cost. For stand-alone electronic prescription systems, the initial incremental costs will be higher because they are expected to need more programming. After the initial year, however, their incremental costs should be similar. These costs will represent a greater percentage increase in their monthly charges, which average $50 per month, but this is unlikely to affect the initial decision of whether to adopt electronic prescribing systems because most of these systems are being provided free to practitioners by insurers that want to encourage electronic prescribing. DEA considers it unlikely that any service provider would attempt to market a product or service that could not be used for controlled substance records and, therefore, no service provider will be disadvantaged by complying because all service providers will incur costs and recover them from customers. The situation may be similar to certification of EHRs by CCHIT. Some were concerned that the standards would create barriers, but most of the companies certified have been small. The chairman of CCHIT, Mark Leavitt, stated that the data on the revenues of firms that gained certification “laid to rest this concern that it was going to squeeze out small vendors. It actually seems to have done the opposite. It's created a level playing field.” 41 41 California HealthCare Foundation, “Gauging the Progress of the National Health Information Technology Initiative: Perspectives from the Field.” January 2008. DEA notes that the barriers to adoption of electronic prescribing cited in various government studies relate to the high cost of the systems, the disruption caused by implementing these systems, and the relatively early stage of system development and interoperability provided by the existing systems. Despite the benefits of legible prescriptions, both in terms of patient safety and fewer callbacks from pharmacies, practitioners have resisted adoption of electronic prescriptions. Insurance companies that have offered the systems for free have had difficulty finding practitioners willing to accept them because while the service is free, the cost of additional hardware, training, and staff disruption is a barrier to adoption. In 2005, Wellpoint offered physicians $42 million in hardware, software, and support. “Of the 25,000 physicians contacted, only 19,000 accepted these free gifts,” Wellpoint then-CEO Leonard Schaeffer said. “And of those 19,000, only 2,700 physicians chose e-prescribing PDAs. The rest selected a paperwork reduction package. * * * Free is not cheap enough,” Schaeffer concluded. 42 The likelihood that the electronic prescribing systems will be part of EHR systems probably is also slowing adoption because practices do not want to invest in a stand-alone system that will be redundant later. 42 Schaeffer, L. WellPoint Health Networks, Thousand Oaks, CA. Transforming an IT-Enabled Health Care System: The Health Plan Role. Presentation at the Second Annual National Health Information Summit. Washington DC, October 20, 2004. *http://www.managedcaremag.com/archives/0504/0504.pharmacy.html* . A study of physicians' experiences with commercial electronic prescription systems that was funded by HHS and published in Health Affairs on April 3, 2007, examined the implementation of electronic prescribing. 43 The study focused on larger medical practices (12 of the 21 practices had more than 50 doctors; none had fewer than 5), which meant that many of the practices had IT staff and support. Many of the problems encountered involved not the basic function of writing a prescription, but other functions that are designed to improve patient safety (e.g., medication histories, clinical decision support) and formulary compliance. Connectivity with pharmacies was also a problem. Practice estimates of the number of prescriptions printed out for the patient ranged from 10 percent to close to 100 percent. Despite the theoretical level of pharmacy readiness for electronic prescriptions, “most practices using electronic fax or EDI [electronic data interchange] reported spending substantial time educating pharmacies about e-prescribing.” Many practices noted that “at least some of the mail-order PBMs [pharmacy benefit managers] routinely rejected prescriptions sent via electronic fax or EDI* * *” 43 Grossman, Joy M. *et al.* , “Physicians' Experiences Using Commercial E-Prescribing Systems,” *Health Affairs* , 26, no. 3 (2007), w393-w404. Implementing a system was reported to be very complicated. One physician reported working with the IT department 4 hours a week for 6 months to iron out the “kinks” in the electronic prescribing module before the system could be tested. Maintenance of the system continued to demand staff resources. The study concluded: Much of the literature assessing barriers to electronic prescribing adoption and use has focused on cost, physician resistance, and changing practice workflow. Our findings highlight the role of product limitations, external implementation challenges, and physicians' preferences for how to use system features and are consistent with several other assessments of e-prescribing system functionality and provider pharmacy connectivity. Respondents' implementation hurdles belie the view that electronic prescribing products are relatively simple “plug-and-play” applications. It is hard to imagine that e-prescribing as it exists today can be the “killer app” that will drive further IT adoption. All of the practices we examined, regardless of size, IT expertise, geographic location, or vendor, had invested many financial and human resources in implementing and maintaining e-prescribing. These findings are consistent with the CDC study cited above, which found that electronic prescribing was one of the less used functions in a fully or partially electronic EMR system. 44 44 Centers for Disease Control and Prevention, “Electronic Medical Record Use by Office-Based Physicians and Their Practices: United States 2006.” *Advance Data from Vital and Health Statistics* , Number 393, October 26, 2007. Creating an electronic prescription takes more time than writing a paper prescription and handing it to a patient. The electronic prescription system shifts some responsibility from the pharmacy to the practitioners. At present, it is the pharmacy that checks to see if a particular drug is covered by the patient's insurance and that checks for drug interactions by examining other medications the patient is taking. With electronic prescriptions, all of these checks may occur before the practitioner signs the prescription. While this process may significantly reduce processing time at the pharmacy and ensure that more prescribed drugs are on the insurance companies' formularies, it may substantially increase the time a practitioner must spend to create a prescription. Rather than spending a few seconds writing a prescription while talking to the patient, the practitioner has to move through a series of drop-down menus to select the patient, drug, dosage unit, and directions, then determine whether the insurance company will cover it and at what level of co-pay. Finally the practitioner will have to find the pharmacy from a drop-down menu. Electronic prescriptions are likely to save practices staff time in reduced callbacks, but the practitioners may initially see mainly the additional time that needs to be spent creating the prescription and the office disruption that occurs when staff need to be trained on new systems. (An earlier Rand study noted that although electronic prescriptions will eliminate errors caused by misread or misunderstood prescriptions, practitioners may not review the prescription to check that the right items from successive menus have been selected. Electronic prescriptions may introduce new errors through system design flaws. They may also reduce the likelihood that the pharmacy will check the prescription for errors.) 45 45 Bell, D.S. *et al.* , “Recommendations for Comparing Electronic Prescribing Systems: Results of An Expert Consensus Process,” *Health Affairs* , May 25, 2004, W4-305-317. DEA recognizes that the rule could potentially impose a burden on service providers, but the costs are not so great that a service provider would not be able to recover them from customers or that the incremental price increase would discourage customers from purchasing a system. The programming that may be needed to implement a conforming system is not so onerous that a service provider would find it a significant burden; designing and programming systems is what these companies do. The cost of the annual third-party audit may be burdensome, but without the audit there is no assurance that the system is protected against identity theft and insider attacks, two of the most likely sources of diversion. DEA expects that some service providers may drop out of the market if they cannot meet the security standards that an auditor would demand, but given other government requirements for security under HIPAA and the public's expectations for secure medical records, DEA believes that these providers would not be able to meet other standards and public expectations. The market for healthcare IT is evolving rapidly. As discussed above, DEA anticipates that most of the current providers will not be in this market by the time most practitioners have adopted EHR systems. Eventually, for reasons unrelated to DEA, a few systems will dominate the market; for these service providers, DEA's requirements will not be a burden. Further information on small business costs is included in the *Initial Economic Impact Analysis of the Electronic Prescriptions for Controlled Substances Rule* . Paperwork Reduction Act The Department of Justice, Drug Enforcement Administration, has submitted the following information collection request to the Office of Management and Budget for review and clearance in accordance with review procedures of the Paperwork Reduction Act of 1995. The proposed information collection is published to obtain comments from the public and affected agencies. All comments and suggestions, or questions regarding additional information, to include obtaining a copy of the proposed information collection instrument with instructions, should be directed to Mark W. Caverly, Chief, Liaison and Policy Section, Office of Diversion Control, Drug Enforcement Administration, 8701 Morrissette Drive, Springfield, VA 22152. Written comments and suggestions from the public and affected agencies concerning the proposed collection of information are encouraged. Comments regarding the information collection-related aspects of this proposed rule should address one or more of the following four points:

(1)Evaluate whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility;

(2)Evaluate the accuracy of the agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used;

(3)Enhance the quality, utility, and clarity of the information to be collected; and

(4)Minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology, e.g., permitting electronic submission of responses. Overview of This Information Collection

(1)*Type of Information Collection:* New collection.

(2)*Title of the Form/Collection:* Recordkeeping for electronic prescriptions for controlled substances.

(3)*Agency form number, if any, and the applicable component of the Department of Justice sponsoring the collection:* *Form number:* None. Office of Diversion Control, Drug Enforcement Administration, Department of Justice.

(4)Affected public who will be asked or required to respond, as well as a brief abstract: *Primary:* Business or other for-profit. *Other:* None. *Abstract:* DEA would require that a DEA-registered hospital, State board, or law enforcement agency check a government-issued photographic identification. The practitioner would mail the signed document that the identification check has occurred to the service provider, which would be required to check the validity of a registrant's DEA registration and State license and retain a record of the check. The service provider would also be required to contact the practitioner by phone to verify the submission. DEA would require practitioners to review, on a monthly basis, a log of controlled substance prescriptions they have written and indicate that they have done so. The service provider would be required to retain a record that the log was reviewed and would be required to retain a digitally signed copy of the prescription as transmitted. Pharmacy systems would be required to digitally sign and archive the prescription as received. All service providers would be required to post a copy of the report of an annual third-party audit.

(5)*An estimate of the total number of respondents and the amount of time estimated for an average respondent to respond:* Over the three years of this information collection request, DEA estimates that a maximum of 110 electronic prescription service providers, 20 pharmacy service providers, and 81,000 practitioners will comply with this proposed rule. The practitioners are estimated to spend 11 minutes for identity proofing, 2 minutes for mailing, and 24 minutes a year for log review. The entity conducting the in-person identity proofing would spend 10 minutes for identity proofing. Service providers would spend 13 minutes on identity proofing per practitioner. They will also spend 500 hours (for EHR and pharmacy ASP systems) or 2,000 hours (for stand-alone electronic prescription and installed pharmacy systems) in the first year programming the systems to meet the requirements. No costs are associated with digitally signing or retaining electronic records. These functions are handled by computers; service providers already retain prescription records as part of normal business practices.

(6)*An estimate of the total public burden (in hours) associated with the collection:* 211,000 hours over three years, an average of 70,200 hours per year. If additional information is required contact: Lynn Bryant, Department Clearance Officer, Information Management and Security Staff, Justice Management Division, Department of Justice, Patrick Henry Building, Suite 1600, 601 D Street, NW., Washington, DC 20530. Congressional Review Act It has been determined that this rule is a major rule as defined by Section 804 of the Small Business Regulatory Enforcement Fairness Act of 1996 (Congressional Review Act). This rule is voluntary and could result in a net reduction in costs. This rule will not result in a major increase in costs or prices; or significant adverse effects on competition, employment, investment, productivity, innovation, or on the ability of United States-based companies to compete with foreign-based companies in domestic and export markets. Executive Order 12988 This regulation meets the applicable standards set forth in Sections 3(a) and 3(b)(2) of Executive Order 12988 Civil Justice Reform. Executive Order 13132 This rulemaking does not preempt or modify any provision of State law; nor does it impose enforcement responsibilities on any State; nor does it diminish the power of any State to enforce its own laws. Accordingly, this rulemaking does not have federalism implications warranting the application of Executive Order 13132. Unfunded Mandates Reform Act of 1995 This rule will not result in the net expenditure by State, local, and tribal governments, in the aggregate, or by the private sector, of $120,000,000 or more (adjusted for inflation) in any one year and will not significantly or uniquely affect small governments. Because this proposed rule will not affect other government, no actions were deemed necessary under the provisions of the Unfunded Mandates Reform Act of 1995. The economic impact on private entities is analyzed in the *Draft Economic Impact Analysis of the Proposed Electronic Prescription Rule* . Cost savings will exceed direct costs. List of Subjects 21 CFR Part 1300 Chemicals, Drug traffic control. 21 CFR Part 1304 Drug traffic control, Reporting and recordkeeping requirements. 21 CFR Part 1306 Drug traffic control, Prescription drugs. 21 CFR Part 1311 Administrative practice and procedure, Certification authorities, Controlled substances, Digital certificates, Drug traffic control, Electronic signatures, Prescription drugs, Reporting and recordkeeping requirements. For the reasons set out above, 21 CFR parts 1300, 1304, 1306, and 1311 are proposed to be amended as follows: PART 1300—DEFINITIONS 1. The authority citation for part 1300 continues to read as follows: Authority: 21 U.S.C. 802, 871(b), 951, 958(f). 2. Section 1300.03 is added to read as follows: § 1300.03 Definitions relating to electronic orders for controlled substances and electronic prescriptions for controlled substances. *Audit* means an independent review and examination of records and activities to assess the adequacy of system controls, to ensure compliance with established policies and operational procedures, and to recommend necessary changes in controls, policies, or procedures. *Audit Trail* means a record showing who has accessed an information technology system and what operations the user performed during a given period. *Authentication* means verifying the identity of the user as a prerequisite to allowing access to the information system. *Authentication protocol* means a well specified message exchange process that verifies possession of a token to remotely authenticate a prescriber. *Biometric authentication* means authentication based on measurement of the individual's physical features or repeatable actions where those features or actions are both unique to the individual and measurable. *Cache* means to download and store information on a local server or hard drive. *Certificate Policy* means a named set of rules that sets forth the applicability of the specific digital certificate to a particular community or class of application with common security requirements. *Certificate Revocation List (CRL)* means a list of revoked, but unexpired certificates issued by a Certification Authority. *Certification Authority (CA)* means an organization that is responsible for verifying the identity of applicants, authorizing and issuing a digital certificate, maintaining a directory of public keys, and maintaining a Certificate Revocation List. *CSOS* means controlled substance ordering system. *Digital certificate* means a data record that, at a minimum—

(1)Identifies the certification authority issuing it;

(2)Names or otherwise identifies the certificate holder;

(3)Contains a public key that corresponds to a private key under the sole control of the certificate holder;

(4)Identifies the operational period; and

(5)Contains a serial number and is digitally signed by the Certification Authority issuing it. *Digital signature* means a record created when a file is algorithmically transformed into a fixed length digest that is then encrypted using an asymmetric cryptographic private key associated with a digital certificate. The combination of the encryption and algorithm transformation ensure that the signer's identity and the integrity of the file can be confirmed. *Digitally sign* means to affix a digital signature to a data file. *Electronic prescription* means a prescription that is generated on an electronic system and transmitted as an electronic data file. An electronic prescription must comply with the requirements of parts 1306 and 1311 of this chapter. A prescription generated on an electronic system that is printed out or transmitted via facsimile to a pharmacy is not considered to be an electronic prescription and must be manually signed. *Electronic signature* means a method of signing an electronic message that identifies a particular person as the source of the message and indicates the person's approval of the information contained in the message. *FIPS* means Federal Information Processing Standards. These Federal standards, as incorporated by reference in § 1311.08 of this chapter, prescribe specific performance requirements, practices, formats, communications protocols, etc., for hardware, software, data, etc. *FIPS 140-2* , as incorporated by reference in § 1311.08 of this chapter, means a Federal standard for security requirements for cryptographic modules. *FIPS 180-2* , as incorporated by reference in § 1311.08 of this chapter, means a Federal secure hash standard. *FIPS 186-2* , as incorporated by reference in § 1311.08 of this chapter, means a Federal standard for applications used to generate and rely upon digital signatures. *Hard token* means a cryptographic key stored on a special hardware device (e.g., a PDA, cell phone, smart card) rather than on a general purpose computer. *Identity Proofing* means the process by which a service provider validates sufficient information to uniquely identify a person. *Intermediary* means any technology system that receives and transmits an electronic prescription between the practitioner and pharmacy. *Key pair* means two mathematically related keys having the properties that

(1)one key can be used to encrypt a message that can only be decrypted using the other key and

(2)even knowing one key, it is computationally infeasible to discover the other key. *NIST* means the National Institute of Standards and Technology. *NIST SP-800-63* , as incorporated by reference in § 1311.08 of this chapter, means a Federal standard for electronic authentication. *Paper prescription* means a prescription created on paper or computer generated to be printed or transmitted via facsimile that meets the requirements of part 1306 of this chapter including a manual signature. *PDA* means a Personal Digital Assistant, a handheld computer used to manage contacts, appointments, and tasks. *Private key* means the key of a key pair that is used to create a digital signature. *Public key* means the key of a key pair that is used to verify a digital signature. The public key is made available to anyone who will receive digitally signed messages from the holder of the key pair. *Public Key Infrastructure (PKI)* means a structure under which a Certification Authority verifies the identity of applicants, issues, renews, and revokes digital certificates, maintains a registry of public keys, and maintains an up-to-date Certificate Revocation List. *SAS 70 Audit* means a third-party audit of a technology provider that meets the American Institute of Certified Public Accountants (AICPA) Statement of Auditing Standards

(SAS)70 criteria. *Service provider* means a trusted entity that does one or more of the following:

(1)Issues or registers practitioner tokens and issues electronic credentials to practitioners.

(2)Provides the technology system (software or service) used to create and send electronic prescriptions.

(3)Provides the technology system (software or service) used to receive and process electronic prescriptions at a pharmacy. *SysTrust* means a professional service performed by a qualified certified public accountant to evaluate one or more aspects of electronic systems. *Token* means something a person possesses and controls (typically a key or password) used to authenticate the person's identity. *Valid prescription* means a prescription that is issued for a legitimate medical purpose by an individual practitioner licensed by law to administer and prescribe the drugs concerned and acting in the usual course of the practitioner's professional practice. *WebTrust* means a professional service performed by a qualified certified public accountant to evaluate one or more aspects of Web sites. PART 1304—RECORDS AND REPORTS OF REGISTRANTS 3. The authority citation for part 1304 continues to read as follows: Authority: 21 U.S.C. 821, 827, 871(b), 958(e), 965, unless otherwise noted. 4. Section 1304.04 is amended by revising paragraph

(b)introductory text, paragraph (b)(1), and paragraph

(h)to read as follows: § 1304.04 Maintenance of records and inventories.

(b)All registrants that are authorized to maintain a central recordkeeping system under paragraph

(a)of this section shall be subject to the following conditions:

(1)The records to be maintained at the central record location shall not include executed order forms and inventories, which shall be maintained at each registered location.

(h)Each registered pharmacy shall maintain the inventories and records of controlled substances as follows:

(1)Inventories and records of all controlled substances listed in Schedule II shall be maintained separately from all other records of the pharmacy.

(2)Paper prescriptions for Schedule II controlled substances shall be maintained at the registered location in a separate prescription file.

(3)Inventories and records of Schedules III, IV, and V controlled substances shall be maintained either separately from all other records of the pharmacy or in such form that the information required is readily retrievable from ordinary business records of the pharmacy.

(4)Paper prescriptions for Schedules III, IV, and V controlled substances shall be maintained at the registered location either in a separate prescription file for Schedules III, IV, and V controlled substances only or in such form that they are readily retrievable from the other prescription records of the pharmacy. Prescriptions will be deemed readily retrievable if, at the time they are initially filed, the face of the prescription is stamped in red ink in the lower right corner with the letter “C” no less than 1 inch high and filed either in the prescription file for controlled substances listed in Schedules I and II or in the usual consecutively numbered prescription file for noncontrolled substances. However, if a pharmacy employs a computer system for prescriptions that permits identification by prescription number and retrieval of original documents by prescriber's name, patient's name, drug dispensed, and date filled, then the requirement to mark the hard copy prescription with a red “C” is waived.

(5)Records of electronic prescriptions for controlled substances shall be maintained in a system that meets the requirements of Part 1311 of this chapter. The computers on which the records are maintained may be located at another location, but the records must be immediately accessible at the registered location if requested by the Administration or other law enforcement agent. The electronic system must be capable of printing out or transferring the records in a format that is readily understandable to an Administration or other law enforcement agent at the registered location. Electronic copies of prescription records must be sortable by prescriber name, patient name, drug dispensed, and date filled. PART 1306—PRESCRIPTIONS 5. The authority citation for part 1306 continues to read as follows: Authority: 21 U.S.C. 821, 829, 871(b), unless otherwise noted. 6. Section 1306.05 is revised to read as follows: § 1306.05 Manner of issuance of prescriptions.

(a)All prescriptions for controlled substances must be dated as of, and signed on, the day when issued and must bear the full name and address of the patient, the drug name, strength, dosage form, quantity prescribed, directions for use, and the name, address and registration number of the practitioner.

(b)A prescription for a Schedule III, IV, or V narcotic drug approved by FDA specifically for “detoxification treatment” or “maintenance treatment” must include the identification number issued by the Administrator under § 1301.28(d) of this chapter or a written notice stating that the practitioner is acting under the good faith exception of § 1301.28(e).

(c)Where a prescription is for gamma-hydroxybutyric acid, the practitioner shall note on the face of the prescription the medical need of the patient for the prescription.

(d)A practitioner may sign a paper prescription in the same manner as he would sign a check or legal document (e.g., J.H. Smith or John H. Smith). Where an oral order is not permitted, paper prescriptions must be written with ink or indelible pencil, typewriter, or printed on a computer printer and must be manually signed by the practitioner. A computer-generated prescription that is printed out or faxed must be manually signed.

(e)Electronic prescriptions must be created and signed using a system that meets the requirements of part 1311 of this chapter.

(f)A prescription may be prepared by the secretary or agent for the signature of a practitioner, but the prescribing practitioner is responsible in case the prescription does not conform in all essential respects to the law and regulations. A corresponding liability rests upon the pharmacist, including a pharmacist employed by a central fill pharmacy, who fills a prescription not prepared in the form prescribed by DEA regulations.

(g)An individual practitioner exempted from registration under § 1301.22(c) of this chapter must include on all prescriptions issued by him/her the registration number of the hospital or other institution and the special internal code number assigned to him/her by the hospital or other institution as provided in § 1301.22(c) of this chapter, in lieu of the registration number of the practitioner required by this section. Each paper prescription must have the name of the physician stamped, typed, or handprinted on it, as well as the signature of the physician.

(h)An official exempted from registration under § 1301.23(a) must include on all prescriptions issued by him/her his/her branch of service or agency (e.g., “U.S. Army” or “Public Health Service”) and his/her service identification number, in lieu of the registration number of the practitioner required by this section. The service identification number for a Public Health Service employee is his/her Social Security identification number. Each paper prescription must have the name of the officer stamped, typed, or handprinted on it, as well as the signature of the officer. 7. Section 1306.08 is added to read as follows: § 1306.08 Electronic prescriptions.

(a)An individual practitioner may sign and transmit electronic prescriptions for controlled substances provided the practitioner meets all of the following requirements:

(1)The practitioner must comply with all other requirements for issuing controlled substance prescriptions in this part;

(2)The practitioner must use a system or service provider that meets the requirements of part 1311 of this chapter; and

(3)The practitioner must comply with the requirements for practitioners in part 1311 of this chapter.

(b)A pharmacy may fill an electronically transmitted prescription for a controlled substance provided the pharmacy complies with all other requirements for filling controlled substance prescriptions in this part and with the requirements of part 1311 of this chapter.

(c)To annotate an electronic prescription, a pharmacist must include all of the information required by this part for the record.

(d)If the content of any of the information required under § 1306.05 for a controlled substance prescription is altered during the transmission, the prescription is deemed to be invalid and the pharmacy may not dispense the controlled substance. 8. In § 1306.11, paragraphs (a), (c), (d)(1), and (d)(4) are revised to read as follows: § 1306.11 Requirement of prescription.

(a)A pharmacist may dispense directly a Schedule II controlled substance that is a prescription drug as determined under the Federal Food, Drug, and Cosmetic Act only pursuant to a written prescription signed by the practitioner, except as provided in paragraph

(d)of this section. A paper prescription for a Schedule II controlled substance may be transmitted by the practitioner or the practitioner's agent to a pharmacy via facsimile equipment, provided that the original manually signed prescription is presented to the pharmacist for review prior to the actual dispensing of the controlled substance, except as noted in paragraph (e), (f), or

(g)of this section. The original paper prescription must be maintained in accordance with § 1304.04(h) of this chapter.

(c)An institutional practitioner may administer or dispense directly (but not prescribe) a controlled substance listed in Schedule II only pursuant to a written prescription signed by the prescribing individual practitioner or to an order for medication made by an individual practitioner that is dispensed for immediate administration to the ultimate user.

(d)* * *

(1)The quantity prescribed and dispensed is limited to the amount adequate to treat the patient during the emergency period (dispensing beyond the emergency period must be pursuant to a paper or electronic prescription signed by the prescribing individual practitioner); * * *

(4)Within 7 days after authorizing an emergency oral prescription, the prescribing individual practitioner must cause a written prescription for the emergency quantity prescribed to be delivered to the dispensing pharmacist. In addition to conforming to the requirements of § 1306.05, the prescription must have written on its face “Authorization for Emergency Dispensing,” and the date of the oral order. The paper prescription may be delivered to the pharmacist in person or by mail, but if delivered by mail it must be postmarked within the 7-day period. Upon receipt, the dispensing pharmacist must attach this paper prescription to the oral emergency prescription that had earlier been reduced to writing. For electronic prescriptions, the pharmacist must annotate the record of the electronic prescription with the original authorization and date of the oral order. The pharmacist must notify the nearest office of the Administration if the prescribing individual practitioner fails to deliver a written prescription to him/her; failure of the pharmacist to do so shall void the authority conferred by this paragraph to dispense without a written prescription of a prescribing individual practitioner. 9. In § 1306.13, paragraph

(a)is revised to read as follows: § 1306.13 Partial filling of prescriptions.

(a)The partial filling of a prescription for a controlled substance listed in Schedule II is permissible if the pharmacist is unable to supply the full quantity called for in a written or emergency oral prescription and he makes a notation of the quantity supplied on the face of the written prescription, written record of the emergency oral prescription, or in the electronic prescription record. The remaining portion of the prescription may be filled within 72 hours of the first partial filling; however, if the remaining portion is not or cannot be filled within the 72-hour period, the pharmacist must notify the prescribing individual practitioner. No further quantity may be supplied beyond 72 hours without a new prescription. 10. In § 1306.15, paragraph (a)(1) is revised to read as follows: § 1306.15 Provision of prescription information between retail pharmacies and central fill pharmacies for prescriptions of Schedule II controlled substances.

(a)* * *

(1)Write the word “CENTRAL FILL” on the face of the original paper prescription and record the name, address, and DEA registration number of the central fill pharmacy to which the prescription has been transmitted, the name of the retail pharmacy pharmacist transmitting the prescription, and the date of transmittal; for electronic prescriptions the name, address, and DEA registration number of the central fill pharmacy to which the prescription has been transmitted, the name of the retail pharmacy pharmacist transmitting the prescription, and the date of transmittal must be added to the electronic prescription record. 11. In § 1306.21, paragraphs

(a)and

(c)are revised to read as follows: § 1306.21 Requirement of prescriptions.

(a)A pharmacist may dispense directly a controlled substance listed in Schedule III, IV, or V that is a prescription drug as determined under the Federal Food, Drug, and Cosmetic Act, only pursuant to either a paper prescription signed by a practitioner, a facsimile of a signed paper prescription transmitted by the practitioner or the practitioner's agent to the pharmacy, an electronic prescription that meets the requirements of this part and part 1311 of this chapter, or an oral prescription made by an individual practitioner and promptly reduced to writing by the pharmacist containing all information required in § 1306.05, except for the signature of the practitioner.

(c)An institutional practitioner may administer or dispense directly (but not prescribe) a controlled substance listed in Schedule III, IV, or V only pursuant to a paper prescription signed by an individual practitioner, a facsimile of a paper prescription or order for medication transmitted by the practitioner or the practitioner's agent to the institutional practitioner-pharmacist, an electronic prescription that meets the requirements of this part and part 1311 of this chapter, or an oral prescription made by an individual practitioner and promptly reduced to writing by the pharmacist (containing all information required in § 1306.05 except for the signature of the individual practitioner), or pursuant to an order for medication made by an individual practitioner that is dispensed for immediate administration to the ultimate user, subject to § 1306.07. 12. Section 1306.22 is revised to read as follows: § 1306.22 Refilling of prescriptions.

(a)No prescription for a controlled substance listed in Schedule III or IV shall be filled or refilled more than six months after the date on which such prescription was issued. No prescription for a controlled substance listed in Schedule III or IV authorized to be refilled may be refilled more than five times.

(b)Each refilling of a prescription shall be entered on the back of the prescription or on another appropriate document or electronic prescription record. If entered on another document, such as a medication record, or electronic prescription record, the document or record must be uniformly maintained and readily retrievable.

(c)The following information must be retrievable by the prescription number:

(1)The name and dosage form of the controlled substance.

(2)The date filled or refilled.

(3)The quantity dispensed.

(4)The initials of the dispensing pharmacist for each refill.

(5)The total number of refills for that prescription.

(d)If the pharmacist merely initials and dates the back of the prescription or annotates the electronic prescription record, it shall be deemed that the full face amount of the prescription has been dispensed.

(e)The prescribing practitioner may authorize additional refills of Schedule III or IV controlled substances on the original prescription through an oral refill authorization transmitted to the pharmacist provided the following conditions are met:

(1)The total quantity authorized, including the amount of the original prescription, does not exceed five refills nor extend beyond six months from the date of issue of the original prescription.

(2)The pharmacist obtaining the oral authorization records on the reverse of the original paper prescription or annotates the electronic prescription record with the date, quantity of refill, number of additional refills authorized, and initials the paper prescription or annotates the electronic prescription record showing who received the authorization from the prescribing practitioner who issued the original prescription.

(3)The quantity of each additional refill authorized is equal to or less than the quantity authorized for the initial filling of the original prescription.

(4)The prescribing practitioner must execute a new and separate prescription for any additional quantities beyond the five refill, six-month limitation.

(f)As an alternative to the procedures provided by paragraphs

(a)through

(e)of this section, a computer system may be used for the storage and retrieval of refill information for original paper prescription orders for controlled substances in Schedule III and IV, subject to the following conditions:

(1)Any such proposed computerized system must provide online retrieval (via computer monitor or hard-copy printout) of original prescription order information for those prescription orders that are currently authorized for refilling. This shall include, but is not limited to, data such as the original prescription number, date of issuance of the original prescription order by the practitioner, full name and address of the patient, name, address, and DEA registration number of the practitioner, and the name, strength, dosage form, quantity of the controlled substance prescribed (and quantity dispensed if different from the quantity prescribed), and the total number of refills authorized by the prescribing practitioner.

(2)Any such proposed computerized system must also provide online retrieval (via computer monitor or hard-copy printout) of the current refill history for Schedule III or IV controlled substance prescription orders (those authorized for refill during the past six months.) This refill history shall include, but is not limited to, the name of the controlled substance, the date of refill, the quantity dispensed, the identification code, or name or initials of the dispensing pharmacist for each refill and the total number of refills dispensed to date for that prescription order.

(3)Documentation of the fact that the refill information entered into the computer each time a pharmacist refills an original paper, fax, or oral prescription order for a Schedule III or IV controlled substance is correct must be provided by the individual pharmacist who makes use of such a system. If such a system provides a hard-copy printout of each day's controlled substance prescription order refill data, that printout shall be verified, dated, and signed by the individual pharmacist who refilled such a prescription order. The individual pharmacist must verify that the data indicated are correct and then sign this document in the same manner as he would sign a check or legal document ( *e.g.* , J. H. Smith, or John H. Smith). This document shall be maintained in a separate file at that pharmacy for a period of two years from the dispensing date. This printout of the day's controlled substance prescription order refill data must be provided to each pharmacy using such a computerized system within 72 hours of the date on which the refill was dispensed. It must be verified and signed by each pharmacist who is involved with such dispensing. In lieu of such a printout, the pharmacy shall maintain a bound log book, or separate file, in which each individual pharmacist involved in such dispensing shall sign a statement (in the manner previously described) each day, attesting to the fact that the refill information entered into the computer that day has been reviewed by him and is correct as shown. Such a book or file must be maintained at the pharmacy employing such a system for a period of two years after the date of dispensing the appropriately authorized refill.

(4)Any such computerized system shall have the capability of producing a printout of any refill data that the user pharmacy is responsible for maintaining under the Act and its implementing regulations. For example, this would include a refill-by-refill audit trail for any specified strength and dosage form of any controlled substance (by either brand or generic name or both). Such a printout must include name of the prescribing practitioner, name and address of the patient, quantity dispensed on each refill, date of dispensing for each refill, name or identification code of the dispensing pharmacist, and the number of the original prescription order. In any computerized system employed by a user pharmacy, the central recordkeeping location must be capable of sending the printout to the pharmacy within 48 hours, and if a DEA Special Agent or Diversion Investigator requests a copy of such printout from the user pharmacy, it must, if requested to do so by the Agent or Investigator, verify the printout transmittal capability of its system by documentation (e.g., postmark).

(5)In the event that a pharmacy which employs such a computerized system experiences system down-time, the pharmacy must have an auxiliary procedure which will be used for documentation of refills of Schedule III and IV controlled substance prescription orders. This auxiliary procedure must ensure that refills are authorized by the original prescription order, that the maximum number of refills has not been exceeded, and that all of the appropriate data are retained for online data entry as soon as the computer system is available for use again.

(g)When filing refill information for original paper, fax, or oral prescription orders for Schedule III or IV controlled substances, a pharmacy may use only one of the two systems described in paragraphs

(a)through

(e)or

(f)of this section.

(h)When filing refill information for electronic prescriptions, a pharmacy must use a system that meets the requirements of part 1311 of this chapter. 13. Section 1306.25 is revised to read as follows: § 1306.25 Transfer between pharmacies of prescription information for Schedules III, IV, and V controlled substances for refill purposes.

(a)The transfer of original paper prescription information for a Schedule III, IV, or V controlled substance for the purpose of refill dispensing is permissible between pharmacies on a one-time basis only. However, pharmacies electronically sharing a real-time, online database may transfer up to the maximum refills permitted by law and the prescriber's authorization.

(b)Electronic prescriptions may be transferred up to the maximum refills permitted by law and the prescriber's authorization.

(c)Transfers of paper prescriptions are subject to the following requirements:

(1)The transfer must be communicated directly between two licensed pharmacists.

(2)The transferring pharmacist must do the following:

(i)Write the word “VOID” on the face of the invalidated prescription.

(ii)Record on the reverse of the invalidated prescription the name, address, and DEA registration number of the pharmacy to which it was transferred and the name of the pharmacist receiving the prescription information.

(iii)Record the date of the transfer and the name of the pharmacist transferring the information.

(3)The pharmacist receiving the transferred paper prescription information must write the word “transfer” on the face of the transferred prescription and reduce to writing all information required to be on a prescription under § 1306.05 and include:

(i)Date of issuance of original prescription.

(ii)Original number of refills authorized on original prescription.

(iii)Date of original dispensing.

(iv)Number of valid refills remaining and date(s) and locations of previous refill(s).

(v)Pharmacy's name, address, DEA registration number, and prescription number from which the prescription information was transferred.

(vi)Name of pharmacist who transferred the prescription.

(vii)Pharmacy's name, address, DEA registration number, and prescription number from which the prescription was originally filled.

(d)For electronic prescriptions, the transferring pharmacist must do the following:

(1)Add information to the record of the original prescription that indicates the following:

(i)That the prescription has been transferred.

(ii)The name, address, and DEA registration number of the pharmacy to which it was transferred.

(iii)The date of the transfer and the name of the pharmacist transferring the information.

(2)Provide the receiving pharmacy with the following information in addition to the original electronic prescription data:

(i)The date of the original dispensing.

(ii)The number of refills remaining and the dates and location of previous refills.

(iii)The transferring pharmacy's name, address, DEA registration number, and prescription number.

(iv)The name of pharmacist transferring the prescription.

(v)The name, address, DEA registration number, and prescription number from the pharmacy that originally filled the prescription, if different.

(e)The pharmacist receiving a transferred electronic prescription must create an electronic record for the prescription that includes the receiving pharmacist's name and all of the information transferred with the prescription under paragraph (d)(2) of this section.

(f)A transferred electronic prescription may be transferred multiple times, as long as there are refills remaining and as long as the dispensing occurs within six months of the date of issue of the prescription.

(g)The original and transferred prescription(s) must be maintained for a period of two years from the date of last refill.

(h)Pharmacies electronically accessing the same prescription record must satisfy all information requirements of a manual mode for prescription transferal.

(i)The procedure allowing the transfer of prescription information for refill purposes is permissible only if allowable under existing State or other applicable law. 14. Section 1306.28 is added to read as follows: § 1306.28 Recordkeeping.

(a)All prescription records required by this part must be maintained as provided in § 1304.04(h) of this chapter.

(b)In addition to any other information required under this part, a pharmacy must retain the following information for each controlled substance prescription filled:

(1)Prescriber's name.

(2)Patient's name and address.

(3)The name and dosage form of the controlled substance.

(4)The quantity dispensed.

(5)The date filled.

(6)The written or typewritten name or initials of the dispensing pharmacist.

(7)The date refilled (Schedule III and IV only).

(8)The total number of refills for the prescription (Schedule III and IV only).

(9)In addition to the requirements of this paragraph, practitioners dispensing gamma-hydroxybutyric acid under a prescription must also comply with § 1304.26 of this chapter. PART 1311—REQUIREMENTS FOR ELECTRONIC ORDERS AND PRESCRIPTIONS 15. The authority citation for part 1311 continues to read as follows: Authority: 21 U.S.C. 821, 828, 829, 871(b), 958(e), 965, unless otherwise noted. 16. The heading for part 1311 is revised to read as set forth above. 17. Section 1311.01 is revised to read as follows: § 1311.01 Scope. This part sets forth the rules governing the creation, transmission, and storage of electronic orders and prescriptions. 18. Section 1311.02 is revised to read as follows: § 1311.02 Definitions. Any term contained in this part shall have the definition set forth in section 102 of the Controlled Substance Act (21 U.S.C. 802) or part 1300 of this chapter. 19. In § 1311.08, paragraph

(a)is amended by adding paragraph (a)(4) to read as follows: § 1311.08 Incorporation by reference.

(a)* * *

(4)NIST SP 800-63, Electronic Authentication Guideline, April 2006. 20. Subpart C, consisting of §§ 1311.100 through 1311.180, is added to read as follows: Subpart C—Electronic Prescriptions Sec. 1311.100 Eligibility to issue electronic prescriptions. 1311.105 Electronic prescription system requirements: Identity proofing. 1311.110 Electronic prescription system requirements: Authentication. 1311.115 Electronic prescription system requirements: Prescription contents. 1311.120 Electronic prescription system requirements: Creating a controlled substance prescription. 1311.125 Electronic prescription system requirements: Signing the prescription. 1311.130 Electronic prescription system requirements: Transmission of electronic prescriptions. 1311.135 Electronic prescription system requirements: Revocation of access authorization. 1311.140 Electronic prescription system requirements: Providing log of prescriptions to practitioner. 1311.145 Electronic prescription system requirements: Security incidents. 1311.150 Electronic prescription system requirements: Third-party audits of service provider systems. 1311.155 Practitioner responsibilities. 1311.160 Pharmacy system requirements: Archiving the initial record. 1311.165 Pharmacy system requirements: Prescription processing. 1311.170 Pharmacy system requirements: Security. 1311.175 Pharmacy responsibilities. 1311.180 Recordkeeping. § 1311.100 Eligibility to issue electronic prescriptions.

(a)A practitioner may issue a controlled substance prescription electronically if both of the following conditions are met:

(1)The practitioner is registered as an individual practitioner or exempt from registration under part 1301 of this chapter and is authorized under the registration or exemption to dispense the controlled substance.

(2)The practitioner uses an electronic prescription system that meets all of the applicable requirements of this subpart.

(b)An electronic prescription created and transmitted using an electronic prescription system that does not meet the requirements of this subpart is not a valid prescription.

(c)The practitioner issuing an electronic controlled substance prescription is responsible if a prescription does not conform in all essential respects to the law and regulations. § 1311.105 Electronic prescription system requirements: Identity proofing.

(a)Before permitting access to the electronic prescription system for signing controlled substance prescriptions, the service provider must receive a document prepared by an entity permitted to conduct in-person identity proofing listed in paragraph

(b)of this section. If a practitioner wishes to electronically prescribe controlled substances in more than one State, the service provider must receive a document prepared by an entity permitted to conduct in-person identity proofing that indicates each of the State licenses and DEA Certificates of Registration. Such document shall be prepared either on the identity proofing entity's letterhead or other official form of correspondence, or the service provider may design a form for use by the identity proofing entity. Regardless of the format of the document, the document must contain all of the following information:

(1)The name and DEA registration number, where applicable, of the entity which conducted the in-person identity proofing of the practitioner;

(2)The name of the person within the entity who conducted the in-person identity proofing of the practitioner;

(3)The name and address of the principal place of business of the practitioner whose identity is being verified; (4)(i) For each State in which the practitioner wishes to prescribe controlled substances electronically, the name of the State licensing authority and State license number of the practitioner whose identity is being verified, or

(ii)If the individual practitioner is an employee of a health care facility that is operated by the Department of Veterans Affairs, confirm that the individual practitioner has been duly appointed to practice at that facility by the Secretary of the Department of Veterans Affairs pursuant to 38 U.S.C. 7401-7408, or

(iii)If the individual practitioner is working at a health care facility operated by the Department of Veterans Affairs on a contractual basis pursuant to 38 U.S.C. 8153 and, in the performance of his duties, prescribes controlled substances, confirm that the individual practitioner meets the criteria for eligibility for appointment under 38 U.S.C. 7401-7408 and is prescribing controlled substances under the registration of such facility;

(5)Except as provided in paragraph (a)(6) of this section, for each State in which the practitioner wishes to prescribe controlled substances electronically, the DEA registration number and date of expiration of DEA registration of the practitioner whose identity is being verified;

(6)For individual practitioners who prescribe controlled substances using the DEA registration of the institutional practitioner, a statement by the institutional practitioner acknowledging the authority of the individual practitioner to prescribe controlled substances using the institution's DEA registration, and the specific internal code number assigned to the individual practitioner;

(7)The type of government-issued photographic identification checked (e.g., the practitioner's driver's license, passport) and a statement that the photograph on the identification matched the person presenting the photographic identification;

(8)The date on which the practitioner's in-person identity proofing was conducted;

(9)The signature of the person within the entity who conducted the in-person identity proofing;

(10)The signature of the practitioner who is the subject of the in-person identity proofing.

(b)The following entities are permitted to conduct in-person identity proofing as described in paragraph

(a)of this section:

(1)The entity within a DEA-registered hospital that has previously granted that practitioner privileges at the hospital (e.g., a hospital credentialing office). The practitioner's privileges must be active and in good standing;

(2)The State professional or licensing board or State controlled substances authority that currently authorizes the practitioner to prescribe controlled substances;

(3)A State or local law enforcement agency.

(c)For each practitioner seeking to issue electronic controlled substances prescriptions, the service provider shall do the following:

(1)Check with each State to determine that the practitioner's State license to practice medicine is current and in good standing. If the individual practitioner is an employee of a health care facility that is operated by the Department of Veterans Affairs, the service provider shall confirm that the individual practitioner has been duly appointed to practice at that facility by the Secretary of the Department of Veterans Affairs pursuant to 38 U.S.C. 7401-7408. If the individual practitioner is working at a health care facility operated by the Department of Veterans Affairs on a contractual basis pursuant to 38 U.S.C. 8153 and, in the performance of his duties, prescribes controlled substances, the service provider shall confirm that the individual practitioner meets the criteria for eligibility for appointment under 38 U.S.C. 7401-7408 and is prescribing controlled substances under the registration of such facility.

(2)In those States in which a separate controlled substance registration is required to prescribe controlled substances, check with the appropriate State authority to determine that the practitioner's State license is current and in good standing.

(3)Except for individual practitioners referred to in paragraph (a)(6) of this section, check the DEA CSA database to determine that the DEA registration for each State is current and in good standing;

(4)Ensure that the service provider has an accurate list of the schedules the practitioner is authorized to prescribe;

(5)Contact the prescribing practitioner at the practitioner's registered location by telephone to confirm the practitioner's intent to apply to prescribe controlled substances using the service provider's system. The service provider must obtain the telephone number from a public source other than the application received from the practitioner. Alternatively, the service provider may confirm the practitioner's intent in person at the practitioner's registered location.

(d)The service provider must retain the document referred to in paragraph

(a)of this section prepared by the entity that conducted the in-person identity proofing for each practitioner prescribing controlled substances electronically using the service provider's system in the manner specified in § 1311.180 of this part. § 1311.110 Electronic prescription system requirements: Authentication.

(a)The system must require that practitioners eligible to issue controlled substance prescriptions use two-factor authentication that meets the requirements of NIST SP 800-63 Level 4 authentication to access the system to sign and transmit controlled substances prescriptions.

(b)The hard token needed to meet NIST SP 800-63 Level 4 authentication must require the entry of a password or biometric to activate the authentication key and must not be able to export the authentication key. The hard token may be a PDA or other handheld device, smart card, thumb drive, etc. The token must be FIPS 140-2 validated as follows:

(1)Overall validation at Level 2 or higher.

(2)Physical security at Level 3 or higher.

(c)The system must require reauthentication if the practitioner does not use the system for more than 2 minutes.

(d)The system must provide a separate authentication protocol for separate DEA registrations. At a minimum, a practitioner must have a separate authentication protocol for each State in which the practitioner holds a DEA registration to dispense controlled substances. The practitioner may store multiple authentication protocols on a single hard token.

(e)The system access authentication protocol must expire no later than the expiration date of the practitioner's DEA registration with which it is associated. § 1311.115 Electronic prescription system requirements: Prescription contents.

(a)An electronic prescription for a controlled substance created by the system must include all of the data elements required under paragraph

(b)of this section and part 1306 of this chapter.

(b)An electronic prescription for a controlled substance must include all of the following information:

(1)The full name and address of the issuing practitioner.

(2)The DEA registration number of the issuing practitioner. For practitioners issuing prescriptions under a hospital or clinic registration number, the prescription must include the registration number and registrant-assigned extension identifier. For military or Public Health Service practitioners exempt from registration, the prescription must include the practitioner's service identification number or Social Security number as required in § 1306.05(h) of this chapter.

(3)The full name and address of the patient for whom the prescription is written.

(4)The drug name, strength, dosage form, quantity prescribed, and directions for use.

(5)The time and date that the prescription was signed.

(c)An electronic prescription for a controlled substance must have the practitioner name, address, and DEA registration number for only the practitioner issuing the prescription. Multiple DEA registration numbers may not be associated with a prescription. § 1311.120 Electronic prescription system requirements: Creating a controlled substance prescription.

(a)The system may allow the registrant or his agent to enter data for a controlled substance prescription.

(b)After the practitioner or his agent has entered the prescription information into the system, the system must display the following information related to the controlled substance prescription:

(1)The patient's name and address.

(2)The name of the drug being prescribed;

(3)The dosage strength and form, quantity, and directions for use.

(4)The DEA registration number under which the prescription will be authorized.

(c)Where more than one controlled substance prescription has been prepared, the practitioner must positively indicate those prescriptions that are to be signed. Any prescription not indicated to be signed shall not be transmitted. § 1311.125 Electronic prescription system requirements: Signing the prescription.

(a)The practitioner must authenticate himself to the system using two-factor authentication immediately before signing the prescription. The system may allow a practitioner to sign multiple prescriptions at the same time.

(b)After a practitioner has authenticated to the system but prior to signing the controlled substance prescription, the system must display for the practitioner's review the information required by § 1311.120(b) for all prescriptions that are to be transmitted in connection with that signature. While such information is displayed, the practitioner must be presented with the following statement (or its substantial equivalent): “I, the prescribing practitioner whose name and DEA registration number appear on the controlled substance prescription(s) being transmitted, have reviewed all of the prescription information listed above and have confirmed that the information for each prescription is accurate. I further declare that by transmitting the prescription(s) information, I am indicating my intent to sign and legally authorize the prescription(s).” The practitioner must positively indicate agreement with this statement. If the practitioner does not indicate agreement to this statement, the controlled substances prescriptions shall not be transmitted.

(c)The service provider must ensure that its prescription-writing system permits practitioners to sign controlled substance prescriptions only if they have the appropriate State authorization and DEA registration to prescribe the schedule of controlled substances being prescribed.

(d)The system must require that the DEA registrant whose DEA number is listed on the prescription sign the prescription. The system must not allow any other person to sign the prescription.

(e)The signing function may take different names depending on the system and the terms used. Regardless of the system labels, signing is the practitioner's attestation that the prescription is accurate and being issued by the practitioner for a legitimate medical purpose in the usual course of professional practice.

(f)The system must include in the data file transmitted an indication that the prescription was signed by the issuing practitioner. § 1311.130 Electronic prescription system requirements: Transmission of electronic prescriptions.

(a)The electronic prescription system must transmit the electronic prescription immediately upon signature by the practitioner.

(b)The electronic prescription system must not allow the printing of an electronic prescription that has been transmitted.

(c)The electronic prescription system must not allow the transmission of an electronic prescription if the prescription has been printed.

(d)The service provider must ensure that the service provider or the first processor of the signed prescription digitally signs a copy of the prescription as received and archives the digitally signed prescription.

(e)The system must retain the archived digitally signed prescription for five years from the date of issuance by the practitioner.

(f)The contents of the prescription listed in § 1311.115(b) must not be altered during transmission. Any change to the content during transmission will render the prescription invalid. The data may be reformatted.

(g)An electronic prescription must be transmitted from the practitioner to the pharmacy in its electronic form. At no time may an electronic prescription be converted to another form for transmission. § 1311.135 Electronic prescription system requirements: Revocation of access authorization.

(a)The service provider must revoke the authentication protocol used to sign controlled substance prescriptions immediately upon receiving notification from the practitioner that a password or token has been compromised, lost, or stolen.

(b)The service provider must revoke the authentication protocol used to sign controlled substance prescriptions on the expiration date of the practitioner's DEA registration unless the service provider determines that the registration has been renewed.

(c)The service provider must check the DEA CSA database at least once a week and revoke the authentication protocol used to sign controlled substance prescriptions for each practitioner using the system whose registration has been terminated, revoked, or suspended. § 1311.140 Electronic prescription system requirements: Providing log of prescriptions to practitioner.

(a)The electronic prescription system must, on a monthly basis, automatically provide the practitioner with an electronic log (which is readily viewable by the practitioner using the system) of all electronic prescriptions for controlled substances that were issued by the practitioner during the previous month using that system.

(b)The electronic prescription system must provide a means for the practitioner to indicate that he has received and reviewed the log.

(c)The electronic prescription system must retain the log provided to the practitioner and a record of the practitioner's indication of the log review for five years.

(d)The electronic prescription system must make available, on the request of the practitioner, a log of all controlled substance prescriptions that the practitioner has transmitted for the previous five years. § 1311.145 Electronic prescription system requirements: Security incidents.

(a)The service provider must audit its records and system at least once a day in a manner sufficient to meet the requirements of paragraph

(b)of this section.

(b)The service provider must notify the Administration within one business day of any security incidents that indicate that any of the following may have occurred:

(1)An individual who is not a DEA registrant has been granted access to issue controlled substance prescriptions.

(2)An individual has been granted access to issue controlled substance prescriptions without identity proofing that meets the requirements of § 1311.105 of this part.

(3)Access to issue controlled substance prescriptions has been granted to a person using another person's identity.

(4)Prescription records have been created or altered by a service provider employee.

(5)There have been one or more successful attempts to penetrate the service provider's system from the outside.

(6)The service provider has identified any other incident that may indicate that the integrity of the system in regard to controlled substance prescriptions has been compromised. § 1311.150 Electronic prescription system requirements: Third-party audits of service provider systems.

(a)The service provider must have a qualified third party conduct an audit that meets the requirements of a WebTrust or SysTrust audit for system security and processing integrity prior to accepting any controlled substances prescriptions for transmission and annually thereafter.

(b)The audit must determine whether the electronic prescription system and the service provider meet the requirements of this part.

(c)The service provider must make the audit report available to any practitioner who uses the system or is considering use of the system. The service provider must retain each annual audit report for the last five years.

(d)If the third-party audit finds that the system does not meet one or more of the requirements of this part or does not provide adequate security against insider and outsider threats, the service provider must not accept for transmission any controlled substance prescription. The service provider must notify practitioners that they should not use the system to generate and transmit controlled substance prescriptions. The service provider must also notify the Administration of the adverse audit report and provide the report to the Administration.

(e)For service providers that install the prescription-writing system on a practitioner's computers and that are not involved in the subsequent transmission of the prescription, the service provider must notify its DEA registrant customers of the results of any third-party audit that finds that the system does not meet one or more of the requirements of this part. The service provider must also notify the Administration of the adverse audit report and provide the report to the Administration. § 1311.155 Practitioner responsibilities.

(a)The practitioner shall provide, or cause to be provided, to the service provider a document from an entity permitted to conduct in-person identity proofing that meets the requirements of § 1311.105 of this part.

(b)The practitioner must retain sole possession of the hard token and must not share the password with any other person. The practitioner must not allow any other person to use the token or enter the password or other identification means to sign prescriptions for controlled substances. Failure by the practitioner to secure the hard token or password may provide a basis for revocation or suspension of registration pursuant to section 304(a)(4) of the Act (21 U.S.C. 824(a)(4)).

(c)The practitioner must notify the service provider within 12 hours of discovery that the hard token has been lost, stolen, or compromised. A practitioner who fails to notify the service provider of the loss, theft, or compromise of the hard token will be held responsible for any controlled substance prescriptions written using the hard token.

(d)The practitioner must review the monthly log to determine whether the prescriptions issued under his DEA registration number were, in fact, issued by him and whether any prescriptions appear to be unusual based on the practitioner's known prescribing pattern. The practitioner must indicate on the log that he has reviewed it. Practitioners are not required to check the log against patient records.

(e)The practitioner must notify both the service provider and the Administration within 12 hours of discovery that one or more prescriptions that were issued under his DEA registration were prescriptions he had not signed or were not consistent with the prescription he signed.

(f)The practitioner must determine initially and at least annually thereafter that the third-party audit report of the service provider indicates that the system and service provider meet the requirements of this part. If the third-party audit report indicates that the system or the service provider does not meet the requirements of this part, or the service provider notifies the practitioner that the system does not meet the requirements of this part, the practitioner must immediately cease to issue electronic controlled substance prescriptions using the system.

(g)The practitioner has the same responsibilities when issuing prescriptions for controlled substances via electronic means as when issuing a paper or oral prescription. Nothing in this part relieves a practitioner of his responsibility to dispense controlled substances only for a legitimate medical purpose while acting in the usual course of his professional practice. If an agent enters information at the practitioner's direction prior to the practitioner reviewing and approving the information and signing and authorizing the transmission of that information, the practitioner is responsible in case the prescription does not conform in all essential respects to the law and regulations. § 1311.160 Pharmacy system requirements: Archiving the initial record.

(a)A copy of each electronic controlled substance prescription record that a pharmacy receives must be digitally signed by one of the following:

(1)The last intermediary transmitting the record to the pharmacy immediately prior to transmission to the pharmacy.

(2)The first pharmacy system that receives the electronic prescription immediately on receipt.

(b)If the last intermediary digitally signs the record, it must forward the digitally signed copy to the pharmacy.

(c)The pharmacy system must archive and retain the digitally signed prescription as received for five years from the date of receipt. § 1311.165 Pharmacy system requirements: Prescription processing.

(a)The pharmacy system must verify that the practitioner's DEA registration was valid at the time the prescription was signed. The pharmacy system may do this by checking the DEA CSA database or by having the prescribing practitioner's service provider or one of the intermediaries check the DEA CSA database during transmission and indicate on the record that the check has occurred and the registration is valid. The CSA database may be cached for one week from the date of issuance.

(b)The pharmacy system must verify that the practitioner signed the prescription by checking the data field that indicates the prescription was signed.

(c)The pharmacy system must reject any of the following controlled substance prescriptions:

(1)A prescription that was not signed.

(2)A prescription that was signed by a practitioner without a valid DEA registration.

(3)A prescription that does not include all of the information required under § 1306.05 of this chapter.

(d)The pharmacy system must be capable of reading and retaining the full DEA registration number, including any extensions, or other identification numbers used under § 1306.05(c) of this chapter. The full number including extensions must be retained in the prescription record.

(e)The pharmacy system must provide for the following information to be added or linked to each controlled substance prescription record for each dispensing, as required in §§ 1304.22(c) and 1306.22 of this chapter:

(1)The number of units or volume of the controlled substance dispensed.

(2)The date of the dispensing.

(3)The full name of the person who dispensed the prescription.

(4)The number of refills allowed.

(f)The pharmacy system must be capable of retrieving information on controlled substance prescriptions by the following data:

(1)Prescriber name.

(2)Patient name.

(3)Drug dispensed.

(4)Date dispensed.

(g)The pharmacy prescription system must be capable of downloading an electronic copy of controlled substance prescription records into a database or spreadsheet format that is readily readable and can be easily sorted by the data elements listed in paragraph

(f)of this section. Such database or spreadsheet must be able to be printed or provided electronically without the need for additional specialized software. § 1311.170 Pharmacy system requirements: Security.

(a)The pharmacy system must create and maintain a backup copy of all controlled substance prescriptions at an alternate storage site that is geographically separated from the primary storage site so as not to be susceptible to the same hazards. A copy of each digitally signed controlled substance prescription and all linked dispensing records must be transferred to the backup storage site at least once every 24 hours. Backup copies must be maintained for five years from the date of the record creation.

(b)The pharmacy system must create and maintain an internal audit trail that indicates each time a controlled substance prescription file is opened, annotated, altered, or deleted and the identity of the person taking the action. The audit trail records must be maintained for five years.

(c)The pharmacy or the service provider must establish and implement a list of auditable events. The auditable events must, at a minimum, include attempted or successful unauthorized access, use, disclosure, modification, or destruction of information or interference with system operations in the prescription system.

(d)The system must analyze the audit logs at least once every 24 hours and generate an incident report that identifies each auditable event.

(e)The pharmacy must determine whether any identified auditable event represents a security incident that compromised or could have compromised the integrity of the prescription records. Any such incidents must be reported to the service provider and the Administration within one business day.

(f)The pharmacy system must have a qualified third party conduct an audit that meets the requirements of a SysTrust or SAS 70 audit for system security and processing integrity prior to accepting any controlled substances prescriptions for processing and annually thereafter.

(g)The third-party audit must determine whether the system for processing controlled substance prescriptions and the service provider meet the requirements of this part. The service provider must make the audit report available to any pharmacy who uses the system. The service provider must retain each annual audit report for the last five years.

(h)If the third-party audit finds that the system does not meet one or more of the requirements of this part or does not provide adequate security against insider and outsider threats, the system must not accept or process any electronic controlled substance prescription. The service provider must notify pharmacies that they should not use the system to accept and process controlled substance prescriptions. The service provider must also notify the Administration of the adverse audit report and provide the report to the Administration.

(i)For service providers that install the prescription-processing system on a pharmacy's computers and that are not involved in the subsequent acceptance and processing of the prescription, the service provider must notify its DEA registrant customers of the results of any third-party audit that finds that the system does not meet one or more of the requirements of this part. The service provider must also notify the Administration of the adverse audit report and provide the report to the Administration. § 1311.175 Pharmacy responsibilities.

(a)A pharmacy must not dispense controlled substances in response to electronic controlled substance prescriptions if its pharmacy system or service provider does not meet the requirements of this part.

(b)A pharmacy must not process electronic controlled substance prescriptions if the DEA registration of the prescriber was not valid at the time the prescription was signed or if the system rejected the prescription for any other reason.

(c)When a pharmacist fills a prescription in a manner that would require, under part 1306 of this chapter, the pharmacist to make a notation on the prescription if the prescription were a paper prescription, the pharmacist must make such notation electronically when filling an electronic prescription.

(d)Nothing in this part relieves a pharmacy of its responsibility to dispense controlled substances only pursuant to a prescription issued for a legitimate medical purpose by a practitioner acting in the usual course of professional practice. § 1311.180 Recordkeeping.

(a)A practitioner, pharmacy, or service provider must maintain records required by this part for electronic prescriptions for five years from their creation. Records may be maintained electronically. Records regarding controlled substances prescriptions that are maintained electronically must be readily retrievable from all other records.

(b)This record retention requirement shall not pre-empt any longer period of retention which may be required now or in the future, by any other Federal or State law or regulation, applicable to practitioners, pharmacists, or pharmacies.

(c)Electronic records must be easily readable or easily rendered into a format that a person can read. They must be made available to the Administration upon request. 21. Subpart D, consisting of §§ 1311.200 through 1311.280, is added to read as follows: Subpart D—Electronic Prescriptions for Federal Agencies Sec. 1311.200 Eligibility to digitally sign electronic prescriptions. 1311.205 Issuance and storage of digital certificates. 1311.210 Digitally signed prescription system requirements: Prescription-writing system requirements. 1311.215 Digitally signed prescription system requirements: Prescription contents. 1311.220 Digitally signed prescription system requirements: Creating a controlled substance prescription. 1311.225 Digitally signed prescription system requirements: Signing the prescription. 1311.230 Digitally signed prescription system requirements: Transmission of electronic prescriptions. 1311.235 Digitally signed prescription system requirements: Revocation of access authorization. 1311.245 Digitally signed prescription system requirements: Security incidents. 1311.250 Digitally signed prescription system requirements: Third-party audits of systems. 1311.255 Practitioner responsibilities. 1311.260 Pharmacy system requirements: Archiving the initial record. 1311.265 Pharmacy system requirements: Prescription processing. 1311.270 Pharmacy system requirements: Security. 1311.275 Pharmacy responsibilities. 1311.280 Recordkeeping. § 1311.200 Eligibility to digitally sign electronic prescriptions.

(a)As an optional alternative to issuing electronic prescriptions for controlled substances under the conditions set forth in Subpart C of this part, a practitioner prescribing controlled substances at a Federal health care facility in the course of their official duties may issue a controlled substance prescription electronically under the conditions set forth in this subpart if both of the following conditions are met:

(2)The practitioner uses an electronic prescription system that meets all of the applicable requirements of this subpart.

(b)For purposes of this section, the term “Federal health care facility” means a hospital or other institution that is operated by an agency of the United States (including the U.S. Army, Navy, Marine Corps, Air Force, Coast Guard, Department of Veterans Affairs, Public Health Service, or Bureau of Prisons).

(c)An electronic prescription created and transmitted using an electronic prescription system that does not meet the requirements of this subpart is not a valid prescription.

(d)The practitioner issuing an electronic controlled substance prescription is responsible if a prescription does not conform in all essential respects to the law and regulations. § 1311.205 Issuance and storage of digital certificates.

(a)Only Federal Certification Authorities or Certification Authorities cross-certified with a Certification Authority operated by the Federal Public Key Infrastructure Policy Authority may issue digital certificates to practitioners prescribing controlled substances at a Federal health care facility in the course of their official duties to sign electronic controlled substance prescriptions.

(b)The digital certificate must be stored on a hardware token that meets the requirements of NIST SP 800-63 Level 4. § 1311.210 Digitally signed prescription system requirements: Prescription-writing system requirements.

(a)Any system may be used to digitally sign electronic prescriptions for controlled substances provided that the system has been enabled to accept digitally signed documents and that it meets the following requirements:

(1)The cryptographic module must be FIPS 140-2 level 1 validated.

(2)The digital signature system and hash function must comply with FIPS 186-2 and FIPS 180-1.

(3)The private key must be stored encrypted on a FIPS 140-2 level 1 validated cryptographic module using a FIPS-approved encryption algorithm.

(4)For software implementations, when the signing module is deactivated, the system must clear the plain text password from the system memory to prevent the unauthorized access to, or use of, the private key.

(5)The system must have a time system that is within five minutes of the official National Institute of Standards and Technology time source.

(b)The system must require that practitioners eligible to issue controlled substance prescriptions use two-factor authentication that meets the requirements of NIST SP 800-63 Level 4 authentication to access the system to sign and transmit controlled substances prescriptions.

(c)The hard token needed to meet NIST SP 800-63 Level 4 authentication must require the entry of a password or biometric to activate the authentication key and must not be able to export the authentication key. The token must be FIPS 140-2 validated as follows:

(1)Overall validation at Level 2 or higher.

(2)Physical security at Level 3 or higher.

(d)The system must require reauthentication if the practitioner does not use the system for more than 2 minutes. § 1311.215 Digitally signed prescription system requirements: Prescription contents. A digitally signed electronic prescription for a controlled substance created by the system must include all of the data elements required under part 1306 of this chapter. § 1311.220 Digitally signed prescription system requirements: Creating a controlled substance prescription.

(a)The system may allow the registrant or his agent to enter data for a controlled substance prescription.

(b)After the practitioner or his agent has entered the prescription information into the system, the system must display the following information related to the controlled substance prescription:

(1)The patient's name and address;

(2)The name of the drug being prescribed;

(3)The dosage strength and form, quantity, and directions for use;

(4)The DEA registration number under which the prescription will be authorized.

(c)Where more than one controlled substance prescription has been prepared, the practitioner must positively indicate those prescriptions that are to be signed. Any prescription not indicated to be signed shall not be transmitted. § 1311.225 Digitally signed prescription system requirements: Signing the prescription.

(b)After a practitioner has authenticated to the system but prior to signing the controlled substance prescription, the system must display for the practitioner's review the information required by § 1311.220(b) for all prescriptions that are to be transmitted in connection with that signature. While such information is displayed, the practitioner must be presented with the following statement (or its substantial equivalent): “I, the prescribing practitioner whose name and DEA registration number appear on the controlled substance prescription(s) being transmitted, have reviewed all of the prescription information listed above and have confirmed that the information for each prescription is accurate. I further declare that by transmitting the prescription(s) information, I am indicating my intent to sign and legally authorize the prescription(s).” The practitioner must positively indicate agreement with this statement. If the practitioner does not indicate agreement to this statement, the controlled substances prescriptions shall not be transmitted.

(c)The Federal agency must ensure that its prescription-writing system permits practitioners to digitally sign controlled substance prescriptions only if they have the appropriate authorization to prescribe the schedule of controlled substances being prescribed.

(d)The system must require that the DEA registrant whose DEA number is listed on the prescription digitally sign the prescription. The system must not allow any other person to sign the prescription.

(e)The system must check the certificate revocation list of the Certification Authority that issued the digital certificate of the practitioner who digitally signed the controlled substance prescription. If the certificate is not valid, the system must not transmit the prescription. The certificate revocation list may be cached until the Certification Authority issues a new certificate revocation list.

(f)If the prescription is being transmitted to a pharmacy that does not accept digitally signed prescriptions, the system must include in the data file transmitted an indication that the prescription was signed by the issuing practitioner. § 1311.230 Digitally signed prescription system requirements: Transmission of electronic prescriptions.

(a)The electronic prescription system must not allow the printing of an electronic prescription that has been transmitted.

(b)The electronic prescription system must not allow the transmission of an electronic prescription if the prescription has been printed.

(c)The system must retain the archived digitally signed prescription for five years from the date of issuance by the practitioner.

(d)The data elements required under part 1306 of this chapter must not be altered during transmission. Any change to the content during transmission will render the prescription invalid. The data may be reformatted.

(e)An electronic prescription must be transmitted from the practitioner to the pharmacy in its electronic form. At no time may an electronic prescription be converted to another form for transmission. § 1311.235 Digitally signed prescription system requirements: Revocation of access authorization.

(a)The system must revoke access to sign controlled substance prescriptions on the expiration date of the practitioner's DEA registration, if applicable, unless the Federal agency determines that the registration or Federal agency authorization has been renewed.

(b)The system must check the DEA CSA database at least once a week and revoke access to signing controlled substance prescriptions for any practitioner using the system whose registration or Federal agency authorization has been terminated, revoked, or suspended. § 1311.245 Digitally signed prescription system requirements: Security incidents.

(a)The Federal agency must audit its controlled substance prescription electronic records and system at least once a day in a manner sufficient to meet the requirements of paragraph

(b)of this section.

(b)The Federal agency must notify the Administration within one business day of any security incidents that indicate that any of the following may have occurred:

(1)An individual who is not a DEA registrant authorized by the Federal agency to prescribe controlled substances in the course of their official duties at the Federal agency has been granted access to issue controlled substance prescriptions.

(2)Access to issue controlled substance prescriptions has been granted to a person using another person's identity.

(3)Prescription records have been created or altered by an employee not authorized to create or annotate a controlled substance record.

(4)There have been one or more successful attempts to penetrate the system from the outside.

(5)The Federal agency has identified any other incident that may indicate that the integrity of the system in regard to controlled substance prescriptions has been compromised. § 1311.250 Digitally signed prescription system requirements: Third-party audits of systems.

(a)The Federal agency must have a third-party audit to verify that the system used to create and transmit controlled substance prescriptions meets the requirements of this subpart prior to accepting any controlled substances prescriptions for transmission and annually thereafter.

(b)The Federal agency must retain each annual audit report for the last five years.

(c)If the third-party audit finds that the system does not meet one or more of the requirements of this part, the system must not accept for transmission any controlled substance prescription. The Federal agency must also notify the Administration of the adverse audit report and provide the report to the Administration. § 1311.255 Practitioner responsibilities.

(a)The practitioner must retain sole possession of the hard token and must not share the password with any other person. The practitioner must not allow any other person to use the token or enter the password or other identification means to sign prescriptions for controlled substances. Failure by the practitioner to secure the hard token or password may provide a basis for revocation or suspension of registration pursuant to section 304(a)(4) of the Act (21 U.S.C. 824(a)(4)).

(b)The practitioner must notify the Certification Authority within 12 hours of discovery that the hard token has been lost, stolen, or compromised. A practitioner who fails to notify the Certification Authority of the loss, theft, or compromise of the hard token will be held responsible for any controlled substance prescriptions written using the hard token.

(c)The practitioner has the same responsibilities when issuing prescriptions for controlled substances via electronic means as when issuing a paper or oral prescription. Nothing in this part relieves a practitioner of his responsibility to dispense controlled substances only for a legitimate medical purpose while acting in the usual course of his professional practice. If an agent enters information at the practitioner's direction prior to the practitioner reviewing and approving the information and signing and authorizing the transmission of that information, the practitioner is responsible in case the prescription does not conform in all essential respects to the law and regulations. § 1311.260 Pharmacy system requirements: Archiving the initial record.

(a)If a pharmacy receives a controlled substance prescription from a Federal agency system that is not transmitted with its digital signature, either the pharmacy must digitally sign the prescription immediately upon receipt, or the last intermediary transmitting the record to the pharmacy must digitally sign the prescription immediately prior to transmission and transmit to the pharmacy the prescription and the digitally signed record. The pharmacy must archive the record as received and the digitally signed copy.

(b)If a Federal pharmacy receives a digitally signed prescription that includes the digital signature, the pharmacy must validate the prescription and archive the digitally signed record. The pharmacy record must retain an indication that the prescription was validated upon receipt. No additional digital signature is required.

(c)The pharmacy system must retain the digitally signed prescription as received for five years from the date of receipt. § 1311.265 Pharmacy system requirements: Prescription processing.

(a)The pharmacy system must verify that the practitioner's DEA registration was valid at the time the prescription was signed. The pharmacy system may do this by checking the DEA CSA database or by having the prescribing practitioner's system or one of the intermediaries check the DEA CSA database during transmission and indicate on the record that the check has occurred and the registration is valid. The CSA database may be cached for one week from the date of issuance.

(b)If the digital signature is not part of the record, the pharmacy system must verify that the practitioner signed the prescription by checking the data field that indicates the prescription was signed.

(c)The pharmacy system must reject any of the following controlled substance prescriptions:

(1)A prescription that was signed by a practitioner without a valid DEA registration.

(2)A prescription that does not include all of the information required under § 1306.05 of this chapter.

(3)If the digital signature is received, a prescription that is not validated.

(1)The number of units or volume of the controlled substance dispensed.

(2)The date of the dispensing.

(3)The full name of the person who dispensed the prescription.

(4)The number of refills allowed.

(f)The pharmacy system must be capable of retrieving information on controlled substance prescriptions by the following data:

(1)Prescriber name.

(2)Patient name.

(3)Drug dispensed.

(4)Date dispensed.

(f)of this section. Such database or spreadsheet must be able to be printed or provided electronically without the need for additional specialized software. § 1311.270 Pharmacy system requirements: Security.

(c)The pharmacy must establish and implement a list of auditable events. The auditable events must, at a minimum, include attempted or successful unauthorized access, use, disclosure, modification, or destruction of information or interference with system operations in the prescription system.

(d)The system must analyze the audit logs at least once every 24 hours and generate an incident report that identifies each auditable event.

(e)The pharmacy must determine whether any identified auditable event represents a security incident that compromised or could have compromised the integrity of the prescription records. Any such incidents must be reported to the Federal agency and the Administration within one business day.

(f)The Federal agency must have a qualified third party conduct an audit for processing integrity prior to accepting any controlled substances prescriptions for processing and annually thereafter.

(g)The third-party audit must determine whether the system for processing controlled substance prescriptions meets the requirements of this part. The Federal agency must retain each annual audit report for the last five years.

(h)If the third-party audit finds that the system does not meet one or more of the requirements of this part, the system must not accept or process any electronic controlled substance prescription. The Federal agency must also notify the Administration of the adverse audit report and provide the report to the Administration. § 1311.275 Pharmacy responsibilities.

(a)A pharmacy must not dispense controlled substances in response to electronic controlled substance prescriptions if its pharmacy system does not meet the requirements of this part.

(b)A pharmacy must not process electronic controlled substance prescriptions if the DEA registration or agency authorization of the prescriber was not valid at the time the prescription was signed or if the system rejected the prescription for any other reason.

(a)A Federal agency or pharmacy must maintain records required by this part for electronic prescriptions for five years from their creation. Records may be maintained electronically. Records regarding controlled substances prescriptions that are maintained electronically must be readily retrievable from all other records.

(b)This record retention requirement shall not preempt any longer period of retention which may be required now or in the future, by any other federal or State law or regulation, applicable to practitioners, pharmacists, or pharmacies.

(c)Electronic records must be easily readable or easily rendered into a format that a person can read. They must be made available to the Administration upon request. Dated: June 6, 2008. Michele M. Leonhart, Acting Administrator. [FR Doc. E8-14405 Filed 6-26-08; 8:45 am] BILLING CODE 4410-09-P 73 125 Friday, June 27, 2008 Presidential Documents Part V The President Proclamation 8271—Termination of the Exercise of Authorities Under the Trading With the Enemy Act With Respect to North Korea Executive Order 13466—Continuing Certain Restrictions With Respect to North Korea and North Korean Nationals Title 3— The President Proclamation 8271 of June 26, 2008 Termination of the Exercise of Authorities Under the Trading With the Enemy Act With Respect to North Korea By the President of the United States of America A Proclamation I, GEORGE W. BUSH, President of the United States of America, by the authority vested in me by the Constitution and the laws of the United States, including section 101(b) of Public Law 95-223 (91 Stat. 1625; 50 U.S.C. App. 5(b) note), hereby find that the continuation of the exercise of authorities under the Trading With the Enemy Act (50 U.S.C. App. 1 *et seq* .)

(TWEA)with respect to North Korea, as authorized in Proclamation 2914 of December 16, 1950, most recently continued under Presidential Determination 2007-32 of September 13, 2007 (72 *FR* 53407), and implemented by the regulations set forth below, is no longer in the national interest of the United States. **Section 1.** The exercise of TWEA authorities with respect to North Korea, which were implemented by the Foreign Assets Control Regulations, 31 C.F.R. part 500, and the Transaction Control Regulations, 31 C.F.R. part 505, and that were continued by Presidential Determination 2007-32 of September 13, 2007, is terminated, and Presidential Determination 2007-32 is rescinded with respect to North Korea. **Sec. 2.** The Secretary of the Treasury is authorized and directed to take all appropriate measures within the Secretary's authority to give effect to this proclamation. **Sec. 3.** This proclamation is not intended to, and does not, create any right, benefit, or privilege, substantive or procedural, enforceable at law or in equity, by any party against the United States, its departments, agencies, instrumentalities, or entities, its officers or employees, or any other person. **Sec. 4.** This proclamation is effective at 12:01 a.m. eastern daylight time on June 27, 2008. IN WITNESS WHEREOF, I have hereunto set my hand this twenty-sixth day of June, in the year of our Lord two thousand eight, and of the Independence of the United States of America the two hundred and thirty-second. GWBOLD.EPS [FR Doc. 08-1398 Filed 6-26-08; 10:27 am]

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