Notices. Notice

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A research copy — for the controlling text, always check the official state or federal source. Not legal advice.

BILLING CODE 4150-24-M DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention [30Day-07-0242X] 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 Estimating the Cost of Sigmoidoscopy and Colonoscopy for Colorectal Cancer Screening in U.S. Healthcare Facilities (SECOST) —New—National Center for Chronic Disease and Public Health Promotion (NCDDPHP), Centers for Disease Control and Prevention (CDC). Background and Brief Description Colorectal cancer

(CRC)is the second leading cause of cancer-related deaths in the United States. In 2005, it was estimated that approximately 56,300 Americans died from CRC and about 145,300 new cases were diagnosed. The risk of developing CRC increases with advancing age. More than 90% of newly diagnosed CRCs occur in persons 50 years of age and older. Several scientific studies have demonstrated that regular screening for CRC reduces the incidence and mortality from this disease. Other studies have shown that regular screening for CRC is also cost-effective in terms of years of life saved. Despite strong scientific evidence and evidence-based clinical guidelines recommending screening, current screening rates remain low. A recent CDC study reported that more than 40 million Americans who are 50 years of age or older and at average risk for CRC have not been screened in accordance with current guidelines. The study also reported that screening this population with current endoscopic ( *i.e.* , flexible sigmoidoscopy and colonoscopy) capacity in the health care system could require as much as ten years to complete. An effective national effort to promote CRC screening could increase the demand for endoscopic procedures. It has been reported that reimbursements for endoscopic procedures in publicly-funded programs may not be adequate to cover the costs of performing these procedures. This may be a disincentive for providers to perform endoscopy procedures. Currently, there is little information available about the resources required or the cost of providing these procedures in different types of healthcare facilities in the United States. The purpose of this project is to conduct a survey of a nationally representative sample of healthcare facilities in order to estimate the average variable costs of providing colonoscopy and flexible sigmoidoscopy for CRC screening and follow-up services. Over time, payments need to cover fixed costs in addition to variable costs. If some facilities have the ability to provide more procedures without additional investment in space or equipment, then recovering fixed costs is not necessary at least in the short run. The estimated average variable cost by procedure will be compared to the reimbursement rates for both screening procedures in order to determine whether the payments to facilities exceed this minimum threshold. Otherwise, facilities will find reimbursement a potential barrier to expansion of CRC screening to uninsured or underinsured populations even if there is underutilized capacity. The study will also determine whether there are factors that affect average variable costs across facilities such as the number of procedures performed, specialization in types of procedures or other characteristics of the facility. Results of this study will be used to better understand the economics of colorectal cancer screening. Respondents include medical facility receptionists, hospital operators, and office/business managers. The total estimated cost to respondents is approximately $72,800 assuming an hourly wage of $37 for office/business managers and an hourly wage of $11 for others during the study period. There are no costs to the respondents other than their time. The total estimated annualized burden hours are 2072. 1 We expect that we will have to make 4,160 screening telephone calls to identify a sample of 1,250 HOPDs and 906 ASCs that are eligible for inclusion in the study. Estimated Annualized Burden Hours Type of respondent Form name Number of respondents Number of responses per respondent Average burden per response (in hours) Receptionist Telephone screening survey 1 4,160 1 5/60 OPHD nurse manager SECOST mail survey 1,000 1 1 ASC nurse manager SECOST mail survey 725 1 1 Dated: February 16, 2007. Joan F. Karr, Acting Reports Clearance Officer, Centers for Disease Control and Prevention. [FR Doc. E7-3099 Filed 2-22-07; 8:45 am] BILLING CODE 4163-18-P DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention Board of Scientific Counselors, National Institute for Occupational Safety and Health: Notice of Charter Renewal This gives notice under the Federal Advisory Committee Act (Pub. L. 92-463) of October 6, 1972, that the Board of Scientific Counselors, National Institute for Occupational Safety and Health, Centers for Disease Control and Prevention, Department of Health and Human Services, has been renewed for a 2-year period through February 3, 2009. For information, contact Dr. Roger Rosa, Executive Secretary, Board of Scientific Counselors, National Institute for Occupational Safety and Health, Centers for Disease Control and Prevention, Department of Health and Human Services, CDC/Washington Office, HHH Building, 200 Independence Ave, SW., Room 715H, MS P12, Washington, DC 20201—telephone 202/205-7856 or fax 202/260-4464. 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 the Centers for Disease Control and Prevention and the Agency for Toxic Substances and Disease Registry. Dated: February 15, 2007. Elaine L. Baker, Acting Director, Management Analysis and Services Office Centers for Disease Control and Prevention. [FR Doc. E7-3103 Filed 2-22-07; 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 Panels (SEP): The Small Business Innovation Research

(SBIR)020, “New Laboratory Tests for Tuberculosis and Detection of Drug Resistance” and SRIB 021, “Development of Novel Information System for Remote Tuberculosis Control and Prevention” 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. *Times and Dates:* 1 p.m.-2 p.m., March 30, 2007 (Closed). 2 p.m.-4 p.m., March 30, 2007 (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 applications received in response to The Small Business Innovation Research

(SBIR)020, “New Laboratory Tests for Tuberculosis and Detection of Drug Resistance” and SRIB 021, “Development of Novel Information System for Remote Tuberculosis Control and Prevention.” *Contact Person for More Information:* J. Felix Rogers, PhD, M.P.H., Scientific Review Administrator, Coordinating Center for Infectious Diseases, National Center for Immunization and Respiratory Diseases, Office of the Director, CDC, 1600 Clifton Road NE., Mailstop E05, Atlanta, GA 30333, Telephone 404.639.6101. 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: February 15, 2007. Elaine L. Baker, Acting Director, Management Analysis and Services Office, Centers for Disease Control and Prevention. [FR Doc. E7-3102 Filed 2-22-07; 8:45 am] BILLING CODE 4163-18-P DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention National Center for Environmental Health/Agency for Toxic Substances and Disease Registry The Health Department Subcommittee of the Board of Scientific Counselors (BSC), Centers for Disease Control and Prevention (CDC), National Center for Environmental Health (NCEH)/Agency for Toxic Substances and Disease Registry (ATSDR): Teleconference Meeting. In accordance with section 10(a)(2) of the Federal Advisory Committee Act (Pub. L. 92-463), the Centers for Disease Control and Prevention, NCEH/ATSDR announces the following teleconference meeting of the aforementioned subcommittee: *Times and Dates:* 12:30 p.m.-2 p.m., March 19, 2007. *Place:* Century Center, 1825 Century Boulevard, Atlanta, Georgia 30345. *Status:* Open to the public, teleconference access limited only by availability of telephone ports. *Purpose:* Under the charge of the Board of Scientific Counselors, NCEH/ATSDR the Health Department Subcommittee will provide the BSC, NCEH/ATSDR with advice and recommendations on local and State health department issues and concerns that pertain to the mandates and mission of NCEH/ATSDR. *Matters to be Discussed:* The meeting will include a review of the agenda; approval of minutes from the last conference call; a discussion on identifying State and Local government issues; a discussion on bridging NCEH/ATSDR programs; public comment and the next steps for the Health Department Subcommittee. Items are subject to change as priorities dictate. *Supplementary Information:* This teleconference meeting is scheduled to begin at 12:30 p.m. Eastern Daylight Savings Time. To participate, please dial 877/315-6535 and enter conference code 383520. The public comment period is scheduled from 1:30 p.m.-1:40 p.m. *Contact Person for More Information:* Shirley D. Little, Committee Management Specialist, NCEH/ATSDR, 1600 Clifton Road, Mail Stop E-28, Atlanta, GA 30303; telephone 404/498-0615, fax 404/498-0059; E-mail: *slittle@cdc.gov* . 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 ATSDR. Dated: February 16, 2007. Elaine L. Baker, Acting Director, Management Analysis and Services Office, Centers for Disease Control and Prevention. [FR Doc. E7-3100 Filed 2-22-07; 8:45 am] BILLING CODE 4163-18-P DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Medicare & Medicaid Services [Document Identifier: CMS-R-131, CMS-10219, CMS-10097, CMS-255, and CMS-437] Agency Information Collection Activities: Proposed Collection; Comment Request AGENCY: Centers for Medicare & Medicaid Services. In compliance with the requirement of section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, the Centers for Medicare & Medicaid Services

(CMS)is publishing the following summary of proposed collections for public comment. Interested persons are invited to send comments regarding this burden estimate or any other aspect of this collection of information, including any of the following subjects:

(1)The necessity and utility of the proposed information collection for the proper performance of the agency's functions;

(2)the accuracy of the estimated burden;

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

(1)Revised, more user friendly language;

(2)combining the two versions of the ABN, the General Use ABN, form CMS-R-131-G, and CMS-R-131-L, which was used specifically for physician-ordered laboratory tests, into a single general notice meeting both needs;

(3)adding the 1-800-MEDICARE number on the notice;

(4)adding information about the beneficiary's right to demand Medicare be billed;

(5)increasing the selection options to 3 from 2, to allow beneficiaries' the right to pay out of pocket when they desire;

(6)allowing a place for other insurance information to be recorded; and

(7)describing the significance of the signature; *Form Number:* CMS-R-131 (OMB#: 0938-0566); *Frequency:* Reporting: Weekly, Monthly, Yearly, Biennially and Occasionally; *Affected Public:* Business or other for-profit and not-for-profit institutions; *Number of Respondents:* 1,270,614; *Total Annual Responses:* 40,302,506; *Total Annual Hours:* 4,701,959. 2. *Type of Information Collection Request:* New collection; *Title of Information Collection:* Health Plan Employer Data And Information Set (HEDIS® ); *Use:* The Centers for Medicare & Medicaid Services

(CMS)collects quality performance measures in order to hold the Medicare managed care industry accountable for the care being delivered, to enable quality improvement, and to provide quality information to Medicare beneficiaries in order to promote an informed choice. It is critical to CMS' mission that we collect and disseminate information that will help beneficiaries choose among health plans, contribute to improved quality of care through identification of improvement opportunities, and assist CMS in carrying out its oversight and purchasing responsibilities. In December 1997, OMB approved the request from CMS for the information collections under HEDIS® and assigned the agency form number CMS-R-200. The collections approved under that request included the HEDIS® collection (following the technical specifications contained in Volume 2, published by the National Committee for Quality Assurance (NCQA); the Health of Seniors/Health Outcomes Survey (HOS); and the Medicare CAHPS® survey. Since that approval there has been a change in the statutory authority as a result of the Balanced Budget Act of 1997. During the latter part of 2000, CMS instituted several policy changes regarding this collection which reduced burden substantially on the part of the managed care organizations and the process for finalizing and publishing that policy delayed the request for OMB approval. In addition, the renewal of OMB authority for the Medicare CAHPS survey was completed as a separate request. The HOS renewal was also submitted separately. This request is solely for the approval of the HEDIS collection, which is now a stand alone collection. *Form Number:* CMS-10219 (OMB#: 0938-NEW); *Frequency:* Yearly; *Affected Public:* Business or other for-profit and Not-for-profit institutions; *Number of Respondents:* 705; *Total Annual Responses:* 705; *Total Annual Hours:* 33,840. 3. *Type of Information Collection Request:* Extension of a currently approved collection; *Title of Information Collection:* Medicare Contractor Provider Satisfaction Survey (MCPSS); *Form No.:* CMS-10097 (OMB# 0938-0915); *Use:* The Centers for Medicare & Medicaid Services will obtain feedback from Medicare providers via a survey about satisfaction, attitudes and perceptions regarding the services provided by Medicare Fee-for-Service

(FFS)Carriers, Fiscal Intermediaries, Durable Medical Equipment Suppliers, and Regional Home Health Intermediaries and Medicare Administrative Contractors. The survey focuses on basic business functions provided by the Medicare Contractors such as inquiries, provider communications, claims processing, appeals, provider enrollment, medical review and provider audit and reimbursement. Providers will receive a notice requesting they use a specially constructed Web site to respond to a set of questions customized for their contractor's responsibilities. The survey will be conducted yearly and annual reports of the survey results will be available via an online reporting system for use by CMS, Medicare Contractors, and the general public. Due to changes in CMS' reporting needs, CMS is requesting a potential increase in the number of completed surveys. This increase will allow CMS to have not only Contractor-specific, but also jurisdiction and state-specific data which, in turn, will enable Contractors to increase and implement performance improvement activities within their organizations. This increase will affect the 2008 and 2009 administrations of the survey. *Frequency:* Reporting—Annually; *Affected Public:* Business or other for-profit, not-for-profit institutions; *Number of Respondents:* 24,279; *Total Annual Responses:* 24,279; Total Annual Hours: 8,346. 4. *Type of Information Collection Request:* Extension of a currently approved collection; *Title of Information Collection:* Municipal Health Services Cost Report; *Form Number:* CMS-255 (OMB# 0938-0155); *Use:* In June 1978, the Robert Wood Johnson Foundation

(RWJF)and Health Care Financing Administration (HCFA), now the Centers for Medicare and Medicaid Services (CMS), agreed to collaborate in demonstrations and evaluations of new methods of delivering and reimbursing medical services in order to simultaneously increase access to primary care and decrease total health care costs per person served. The Municipal Health Services Program

(MHSP)is the first of these cooperative efforts. The chief objective of the MHSP is to assist municipalities in providing health care services to medically underserved areas. By expanding existing programs of health departments and hospitals with a limited increase in a municipality's health budget, services traditionally provided by public health programs and hospital outpatient departments will be brought together in a single locality. Participating clinics are reimbursed for all their routine costs based on the average cost per visit. Ancillary costs are paid according to 14 categories: Laboratory, x-ray, pharmacy, transportation, optometrist, dentist, audiologist, podiatrist, eyeglasses, dentures, devices, physical therapy, speech therapy, and occupational therapy. In order to determine the cost of the clinical services being provided, it is necessary to determine the direct and indirect cost incurred by the participating clinics for the routine and ancillary cost centers. For evaluation purposes, it is necessary to accurately identify the total visit count of the clinics for all patients and for Medicare patients. The MHSP CMS Form 255 cost report is the form that is being used to report the costs to the participating clinics of providing the covered services as well as to gather the data needed to properly evaluate the demonstration. *Frequency:* Recordkeeping and Reporting—Annually; *Affected Public:* Not-for-profit institutions; *Number of Respondents:* 14; *Total Annual Responses:* 14; *Total Annual Hours:* 476. 5. *Type of Information Collection Request:* Extension of a currently approved collection; *Title of Information Collection:* Psychiatric Unit Criteria Worksheet and Supporting Regulations at 42 CFR 412.25 and 412.27. *Form Number:* CMS-437 (OMB# 0938-0358); *Use:* The psychiatric unit criteria worksheets are necessary to verify that these units comply and remain in compliance with the exclusion criteria for the Medicare prospective payment system. *Frequency:* Reporting—Annually; *Affected Public:* Business or other for-profit, not-for-profit institutions, and State, Local and Tribal Government; *Number of Respondents:* 1333; *Total Annual Responses:* 1333; *Total Annual Hours:* 333. To obtain copies of the supporting statement and any related forms for the proposed paperwork collections referenced above, access CMS' Web Site address at *http://www.cms.hhs.gov/PaperworkReductionActof1995* , or E-mail your request, including your address, phone number, OMB number, and CMS document identifier, to *Paperwork@cms.hhs.gov* , or call the Reports Clearance Office on

(410)786-1326. To be assured consideration, comments and recommendations for the proposed information collections must be received at the address below, no later than 5 p.m. on April 24, 2007: CMS, Office of Strategic Operations and Regulatory Affairs, Division of Regulations Development—C, Attention: Bonnie L Harkless, Room C4-26-05, 7500 Security Boulevard, Baltimore, Maryland 21244-1850. Dated: February 13, 2007. Michelle Shortt, Director, Regulations Development Group, Office of Strategic Operations and Regulatory Affairs. [FR Doc. E7-3026 Filed 2-22-07; 8:45 am] BILLING CODE 4120-01-P DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Medicare & Medicaid Services [Document Identifier: CMS-10148] Agency Information Collection Activities: Submission for OMB Review; Comment Request AGENCY: Centers for Medicare & Medicaid Services, HHS. In compliance with the requirement of section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, the Centers for Medicare & Medicaid Services (CMS), Department of Health and Human Services, is publishing the following summary of proposed collections for public comment. Interested persons are invited to send comments regarding this burden estimate or any other aspect of this collection of information, including any of the following subjects:

(1)The necessity and utility of the proposed information collection for the proper performance of the Agency's function;

(2)the accuracy of the estimated burden;

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

(4)the use of automated collection techniques or other forms of information technology to minimize the information collection burden. 1. *Type of Information Collection Request:* Revision of a currently approved collection; *Title of Information Collection:* HIPAA Administrative Simplification Enforcement Non-Privacy Enforcement; *Use:* The Health Insurance Portability and Accountability Act (HIPAA) became law in 1996 (Pub. L. 104-191). Subtitle F of Title II of HIPAA, entitled “Administrative Simplification,” requires the Secretary of HHS to adopt national standards for certain information-related activities of the health care industry. The HIPAA provisions, by statute, apply only to “covered entities” referred to in section 1320d-2(a)(1) of this title. Responsibility for administering and enforcing the HIPAA Administrative Simplification Transactions, Code Sets, Identifiers and Security rules has been delegated to CMS. The initial information collected to enforce these rules will be used to initiate enforcement actions. This information collection change clarifies the “Identify the HIPAA Non-Privacy complaint category” section of the complaint form. In this section, complainants are given an opportunity to check the “Unique Identifiers” option to categorize the type of HIPAA complaint being filed. The revised form now includes a “”For a Unique Identifier Complaint” section, that allows a complaint to further categorize their identifier complaint as either a “National Provider Identifier (NPI)” or an “Employer Identification Number (EIN)” complaint. *Form Number:* CMS-10148 (OMB#: 0938-948); *Frequency:* Reporting—On occasion; *Affected Public:* Individuals or households, Business or other for-profit, Not-for-profit institutions, and State, Local, or Tribal governments; *Number of Respondents:* 500; *Total Annual Responses:* 500; *Total Annual Hours:* 500. To obtain copies of the supporting statement and any related forms for the proposed paperwork collections referenced above, access CMS Web Site address at *http://www.cms.hhs.gov/PaperworkReductionActof1995* , or E-mail your request, including your address, phone number, OMB number, and CMS document identifier, to *Paperwork@cms.hhs.gov* , or call the Reports Clearance Office on

(410)786-1326. Written comments and recommendations for the proposed information collections must be mailed or faxed within 30 days of this notice directly to the OMB desk officer: OMB Human Resources and Housing Branch, Attention: Carolyn Lovett, New Executive Office Building, Room 10235, Washington, DC 20503, Fax Number:

(202)395-6974. Dated: February 13, 2007. Michelle Shortt, Director, Regulations Development Group, Office of Strategic Operations and Regulatory Affairs. [FR Doc. E7-3028 Filed 2-22-07; 8:45 am] BILLING CODE 4120-01-P DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Medicare & Medicaid Services [Document Identifier: CMS-2540-96] Agency Information Collection Activities: Submission for OMB Review; Comment Request AGENCY: Centers for Medicare & Medicaid Services, HHS. In compliance with the requirement of section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, the Centers for Medicare & Medicaid Services (CMS), Department of Health and Human Services, is publishing the following summary of proposed collections for public comment. Interested persons are invited to send comments regarding this burden estimate or any other aspect of this collection of information, including any of the following subjects:

(1)The necessity and utility of the proposed information collection for the proper performance of the Agency's function;

(2)the accuracy of the estimated burden;

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

(202)395-6974. Dated: February 13, 2007. Michelle Shortt, Director, Regulations Development Group, Office of Strategic Operations and Regulatory Affairs. [FR Doc. E7-3032 Filed 2-22-07; 8:45 am] BILLING CODE 4120-01-P DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Medicare & Medicaid Services [CMS-1542-N] Medicare Program; Announcement of New Members to the Advisory Panel on Ambulatory Payment Classification

(APC)Groups AGENCY: Centers for Medicare & Medicaid Services (CMS), Department of Health and Human Services (DHHS). ACTION: Notice. SUMMARY: This notice announces five new members selected to serve on the Advisory Panel on Ambulatory Payment Classification

(APC)Groups (the Panel). The purpose of the Panel is to review the APC groups and their associated weights and to advise the Secretary, DHHS, (the Secretary) and the Administrator, 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 annual updates of the hospital outpatient prospective payment system (OPPS). FURTHER INFORMATION CONTACT: For inquiries about the Panel, please contact the Designated Federal Official (DFO): Shirl Ackerman-Ross, DFO, CMS, CMM, HAPG, DOC, 7500 Security Boulevard, Mail Stop C4-05-17, Baltimore, MD 21244-1850, Phone

(410)786-4474. *E-Mail Address:* The E-mail address for the Panel is as follows: *CMS APCPanel@cms.hhs.gov.* News media representatives must contact our Public Affairs Office at

(202)690-6145. *Advisory Committees' Information Lines:* The CMS Advisory Committees' Information Line is 1-877-449-5659 (toll free) and

(410)786-9379 (local). *Web Site:* For additional information regarding the APC Panel membership, meetings, agendas, and updates to the Panel's activities, please search our Web site at the following: *http://www.cms.hhs.gov/FACA/05_AdvisoryPanelonAmbulatoryPaymentClassificationGroups.asp.* A copy of the Panel's Charter is on that Web site. You may also e-mail the Panel DFO at the above-mentioned e-mail address for a copy of the Charter. 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 redesignated by section 202(a)(2) of the BBRA] to 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 shall consist 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. The Secretary or Administrator selects the Panel membership based upon either self-nominations or nominations submitted by Medicare providers and other interested organizations. All members must have technical expertise to enable them to participate fully in the work of the Panel. This expertise encompasses hospital payment systems; hospital medical-care delivery systems; provider billing systems; APC groups; Current Procedural Terminology and alpha-numeric Healthcare Common Procedure Coding System codes; and the use and payment of drugs and medical devices in the outpatient setting, as well as other forms of relevant expertise. The Charter requires that all members have a minimum of 5 years experience in their area(s) of expertise, but it is not necessary that any member be an expert in all of the areas listed above. For purposes of this Panel, consultants or independent contractors are not considered to be full-time employees of hospitals, hospital systems, or other Medicare providers that are subject to the OPPS. Panel members serve up to 4-year terms. A member may serve after the expiration of his or her term until a successor has been sworn in. All terms are contingent upon the renewal of the Panel's Charter by appropriate action before its termination. The Secretary re-chartered the APC Panel effective November 21, 2006. II. Announcement of New Members The Panel may consist of a Chair and up to 15 Panel members who serve without compensation, according to an advance written agreement. Travel, meals, lodging, and related expenses for the meeting are reimbursed in accordance with standard Government travel regulations. We have a special interest in ensuring that women, minorities, representatives from various geographical locations, and the physically challenged are adequately represented on the Panel. The Secretary, or his designee, appoints new members to the Panel from among those candidates determined to have the required expertise. New appointments are made in a manner that ensures a balanced membership. The Panel presently consists of the following 13 members and a Chair: • Edith Hambrick, M.D., J.D., Chair • Gloryanne Bryant, B.S., R.H.I.A., R.H.I.T., C.C.S. • Albert Brooks Einstein, Jr., M.D. • Hazel Kimmel, R.N., C.C.S., C.P.C. • Sandra J. Metzler, M.B.A., R.H.I.A., C.P.H.Q. • Frank G. Opelka, M.D., F.A.C.S. • Louis Potters, M.D., F.A.C.R. • Lou Ann Schraffenberger, M.B.A., R.H.I.A., C.C.S.-P. • Judie S. Snipes, R.N., M.B.A., F.A.C.H.E. • Timothy Gene Tyler, Pharm.D. • Thomas M. Munger, M.D., F.A.C.C. • James V. Rawson, M.D. • Kim Allan Williams, M.D., F.A.C.C., F.A.B.C. • Robert Matthew Zwolak, M.D., Ph.D., F.A.C.S. On November 22, 2006, we published the notice titled “Request for Nominations to the Advisory Panel on Ambulatory Payment Classification Groups,” (CMS-1305-N) in the **Federal Register** requesting nominations to the Panel replacing Panel members whose terms would expire by September 30, 2007. As a result of that **Federal Register** notice, we are announcing five new members to the Panel. Two new 3 1/2 -year appointments commence on March 1, 2007; two new 3 1/2 -year appointments commence on April 1, 2007; and one new 4-year appointment commences on October 1, 2007, as indicated below: New panel members Terms Patricia Spencer-Cisek, M.S 03/01/2007-09/30/2010 Russ Ranallo, M.S., B.S 03/01/2007-09/30/2010 Beverly Philip, M.D 04/01/2007-09/30/2010 Michael A. Ross, M.D 04/01/2007-09/30/2010 Agatha L. Nolen, M.S., D.Ph 10/01/2007-09/30/2011 Authority: Section 1833(t) of the Act (42 U.S.C. 1395l(t)). The Panel is governed by the provisions of Pub. L. 92-463, as amended (5 U.S.C. Appendix 2).(Catalog of Federal Domestic Assistance Program No. 93.773, Medicare-Hospital Insurance; and Program No. 93.774, Medicare-Supplementary Medical Insurance Program). Dated: February 15, 2007. Leslie V. Norwalk, Acting Administrator, Centers for Medicare & Medicaid Services. [FR Doc. E7-3040 Filed 2-22-07; 8:45 am] BILLING CODE 4120-01-P DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Medicare & Medicaid Services [CMS-2221-N] RIN 0938-ZA98 Medicare, Medicaid, and CLIA Programs; Approval of COLA (Formerly the Commission on Office Laboratory Accreditation) as a CLIA Accreditation Organization AGENCY: Centers for Medicare & Medicaid Services (CMS), HHS. ACTION: Notice. SUMMARY: In this notice, we grant COLA (formerly the Commission on Office Laboratory Accreditation) deeming authority as an accrediting organization for clinical laboratories under the Clinical Laboratory Improvement Amendments of 1988

(CLIA)program. We have determined that the requirements of the COLA accreditation process are equal to or more stringent than the CLIA condition level requirements, and that COLA has met the requirements of subpart E of 42 CFR Part 493. Consequently, laboratories that are voluntarily accredited by COLA and continue to meet COLA requirements will be deemed to meet the CLIA condition-level requirements for laboratories and therefore are not subject to routine inspection by State survey agencies to determine their compliance with Federal requirements. They are, however, subject to Federal validation and complaint investigation surveys conducted by us or our designee. DATES: *Effective Date:* This notice is effective from February 23, 2007 to February 25, 2013. FOR FURTHER INFORMATION CONTACT: Raelene Perfetto,

(410)786-6876. SUPPLEMENTARY INFORMATION: I. Background and Legislative Authority On October 31, 1988, the Congress enacted the Clinical Laboratory Improvement Amendments of 1988 (CLIA), Public Law 100-578. CLIA replaced in its entirety section 353(e)(2) of the Public Health Service Act, as enacted by the Clinical Laboratories Improvement Act of 1967. We issued a final rule implementing the accreditation provisions of CLIA on July 31, 1992, (57 FR 33992). Under the CLIA program, CMS approves a grant of deeming authority to an accreditation organization to accredit clinical laboratories if the organization meets certain requirements. An organization's requirements for accredited laboratories must be equal to, or more stringent than, the applicable CLIA program requirements in 42 CFR part 493 (Laboratory Requirements). The regulations in subpart E (Accreditation by a Private, Nonprofit Accreditation Organization or Exemption Under an Approved State Laboratory Program) specify the requirements an accreditation organization must meet to be an approved accreditation organization. We approve an accreditation organization for a period not to exceed 6 years. In general, the approved accreditation organization must: • Use inspectors qualified to evaluate laboratory performance and agree to inspect laboratories with the frequency determined by us. • Apply standards and criteria that are equal to, or more stringent than, those condition-level requirements established by us. • Assure that laboratories accredited by the accreditation organization continually meet these standards and criteria. • Provide us with the name of any laboratory that has had its accreditation denied, suspended, withdrawn, limited, or revoked within 30 days of the action taken. • Notify us at least 30 days before implementing any proposed changes in its standards. • If we withdraw our approval, notify the accredited laboratories of the withdrawal within 10 days of the withdrawal. CLIA requires that we perform an annual evaluation by inspecting a sufficient number of laboratories accredited by an approved accreditation organization as well as by any other means that we determine to be appropriate. II. Notice of Approval of COLA as an Accreditation Organization In this notice, we approve COLA (formerly the Commission on Office Laboratory Accreditation) as an organization that may accredit laboratories for purposes of establishing their compliance with CLIA requirements. We have examined the COLA application and all subsequent submissions to determine equivalency with our requirements under subpart E of part 493 that an accreditation organization must meet to be approved under CLIA. We have determined that COLA complied with the applicable CLIA requirements and grant COLA approval as an accreditation organization under subpart E, as for the period stated in the “Effective Date” section of this notice for the following specialty and subspecialty areas: • Microbiology, including Bacteriology, Mycobacteriology, Mycology, Parasitology, Virology. • Diagnostic Immunology, including Syphilis Serology, General Immunology. • Chemistry, including Routine Chemistry, Urinalysis, Endocrinology, Toxicology. • Hematology. • Immunohematology, including ABO Group & Rh Group, Antibody Detection, Antibody Identification, Compatibility Testing. • Pathology, including Histopathology, Oral Pathology, Cytology. As a result of this determination, any laboratory that is accredited by COLA during the effective time period for an approved specialty or subspecialty is deemed to meet the CLIA requirements for the laboratories found in part 493 of our regulations and, therefore, is not subject to routine inspection by a State survey agency to determine its compliance with CLIA requirements. The accredited laboratory, however, is subject to validation and complaint investigation surveys performed by us, or by any other validly authorized agent. III. Evaluation of COLA Request for Approval as an Accreditation Organization Under CLIA The following describes the process used to determine that requirements of the COLA accreditation program are equal to or more stringent than the CLIA condition level requirements, and that COLA has met the requirements of subpart E of 42 CFR part 493. COLA formally reapplied to us for approval as an accreditation organization under CLIA for the following specialties and subspecialties: • Microbiology, including Bacteriology, Mycobacteriology, Mycology, Parasitology, Virology. • Diagnostic Immunology, including Syphilis Serology, General Immunology. • Chemistry, including Routine Chemistry, Urinalysis, Endocrinology, Toxicology. • Hematology. • Immunohematology, including ABO Group & Rh Group, Antibody Detection, Antibody Identification, Compatibility Testing. • Pathology, including Histopathology, Oral Pathology, Cytology. We evaluated the COLA application to meet or exceed our implementing and enforcement regulations, and the deeming/exemption requirements of the CLIA rules. We verified that the COLA accreditation program requirements and methods require the laboratories it accredits to be, and that the organization meets or exceeds the following subparts of part 493 as explained below: Subpart E—Accreditation by a Private, Nonprofit Accreditation Organization or Exemption Under an Approved State Laboratory Program COLA submitted the specialties and subspecialties that it would accredit; a comparison of individual accreditation and condition-level requirements; a description of its inspection process; proficiency testing

(PT)program for any of tests listed in subpart I. COLA also encourages its accredited laboratories to participate in PT for tests that are waived under CLIA. Subpart J—Facility Administration for Nonwaived Testing COLA requirements are equal to the CLIA requirements at § 493.1100 through § 493.1105. Subpart K—Quality System for Nonwaived Testing COLA requirements are equal to the CLIA requirements at § 493.1200 through § 493.1299. COLA makes educational material available to its accredited laboratories, which provide further information on quality assurance. As part of good laboratory practice and to ensure accuracy, COLA encourages development of a QC program for tests that are waived under CLIA. Subpart M—Personnel for Nonwaived Testing COLA states as general policy that its personnel standards for accreditation are identical to CLIA. A qualified individual must fulfill the responsibilities of each required position in the laboratory. The laboratory director and laboratory personnel must meet educational and experience requirements. Although certain duties of the laboratory director may be delegated to qualified individuals, the laboratory director remains ultimately responsible. We have determined that COLA requirements are equal to the CLIA requirements at § 493.1403 through § 493.1495 for laboratories that perform moderate and high complexity testing. Subpart Q—Inspections We have determined that the COLA requirements are equal to the CLIA requirements at § 493.1771 through § 493.1780. COLA will continue to perform onsite inspections every 2 years. Subpart R—Enforcement Procedures COLA meets the requirements of subpart R to the extent that it applies to accreditation organizations. COLA policy sets forth the actions the organization takes when laboratories it accredits do not comply with its requirements and standards for accreditation. When appropriate, COLA will deny, suspend, or, revoke accreditation in a laboratory accredited by COLA and report that action to us within 30 days. COLA also provides an appeal process for laboratories that have had accreditation denied, suspended, or revoked. We have determined that COLA's laboratory enforcement and appeal policies are equal to the requirements of part 493 subpart R as they apply to accreditation organizations. IV. Federal Validation Inspections and Continuing Oversight The Federal validation inspections of COLA accredited laboratories may be conducted on a representative sample basis or in response to substantial allegations of noncompliance (that is, complaint inspections). The outcome of those validation inspections, performed by us or our agents, the State survey agencies, will be our principal means for verifying that the laboratories accredited by COLA remain in compliance with CLIA requirements. This Federal monitoring is an ongoing process. V. Removal of Approval as an Accrediting Organization Our regulations provide that we may rescind the approval of an accreditation organization, such as that of COLA, for cause, before the end of the effective date of approval. If we determine that COLA failed to adopt requirements that are equal to, or more stringent than, the CLIA requirements, or that systemic problems exist in its inspection process, we may give it a probationary period, not to exceed 1 year to allow COLA to adopt comparable requirements. Should circumstances result in our withdrawal of the COLA's approval, we will publish a notice in the **Federal Register** explaining the basis for removing its approval. VI. Collection of Information Requirements This notice does not impose any information collection and record keeping requirements subject to the Paperwork Reduction Act (PRA). Consequently, it does not need to be reviewed by the Office of Management and Budget

(OMB)under the authority of the PRA. The requirements associated with the accreditation process for clinical laboratories under the Clinical Laboratory Improvement Amendments of 1988

(CLIA)program, codified in 42 CFR part 493 subpart E, are currently approved by OMB under OMB approval number 0938-0686. VII. Executive Order 12866 Statement In accordance with the provisions of Executive Order 12866, this notice was not reviewed by the Office of Management and Budget. Authority: Section 353 of the Public Health Service Act (42 U.S.C. 263a). Dated: December 7, 2006. Leslie V. Norwalk, Acting Administrator, Centers for Medicare & Medicaid Services. [FR Doc. E7-3025 Filed 2-22-07; 8:45 am] BILLING CODE 4120-01-P DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Medicare & Medicaid Services [CMS-2218-N] RIN 0938-ZA99 Medicare, Medicaid, and CLIA Programs; Approval of the Joint Commission (Formerly the Joint Commission on Accreditation of Healthcare Organizations) as a CLIA Accreditation Organization AGENCY: Centers for Medicare & Medicaid Services (CMS), HHS. ACTION: Notice. SUMMARY: This notice announces CMS' grant of deeming authority to the Joint Commission (formerly the Joint Commission on Accreditation of Healthcare Organizations) under the Clinical Laboratory Improvement Amendments of 1988

(CLIA)program. We have determined that the requirements of the Joint Commission accreditation process are equal to or more stringent than the CLIA condition level requirements, and that the Joint Commission has met the requirements of subpart E of 42 CFR part 493. Consequently, laboratories that are voluntarily accredited by the Joint Commission and continue to meet the Joint Commission requirements will be deemed to meet the CLIA condition level requirements for laboratories and therefore are not subject to routine inspection by State survey agencies to determine their compliance with Federal requirements. They are, however, subject to Federal validation and complaint investigation surveys conducted by us or our designee. DATES: *Effective Date:* This notice is effective from February 23, 2007 to February 23, 2012. FOR FURTHER INFORMATION CONTACT: Kathleen Todd,

(410)786-3385. SUPPLEMENTARY INFORMATION: I. Background and Legislative Authority On October 31, 1988, the Congress enacted the Clinical Laboratory Improvement Amendments of 1988 (CLIA), Public Law 100-578. CLIA replaced in its entirety section 353(e)(2) of the Public Health Service Act, as enacted by the Clinical Laboratories Improvement Act of 1967. We issued a final rule implementing the accreditation provisions of CLIA on July 31, 1992, (57 FR 33992). Under the CLIA program, CMS approves a grant of deeming authority to an accreditation organization to accredit clinical laboratories if the organization meets certain requirements. An organization's requirements for accredited laboratories must be equal to, or more stringent than, the applicable CLIA program requirements in 42 CFR part 493 (Laboratory Requirements). The regulations in subpart E (Accreditation by a Private, Nonprofit Accreditation Organization or Exemption Under an Approved State Laboratory Program) specify the requirements an accreditation organization must meet to be an approved accreditation organization. We approve an accreditation organization for a period not to exceed 6 years. In general, the approved accreditation organization must: • Use inspectors qualified to evaluate laboratory performance and agree to inspect laboratories with the frequency determined by us. • Apply standards and criteria that are equal to, or more stringent than those condition level requirements established by us. • Assure that laboratories accredited by the accreditation organization continually meet these standards and criteria. • Provide us with the name of any laboratory that has had its accreditation denied, suspended, withdrawn, limited, or revoked within 30 days of the action taken. • Notify us at least 30 days before implementing any proposed changes in its standards. • If we withdraw our approval, notify the accredited laboratories of the withdrawal within 10 days of the withdrawal. CLIA requires that we perform an annual evaluation by inspecting a sufficient number of laboratories accredited by an approved accreditation organization as well as by any other means that we determine to be appropriate. II. Notice of Approval of the Joint Commission as an Accreditation Organization In this notice, we approve the Joint Commission as an organization that may accredit laboratories for purposes of establishing their compliance with CLIA requirements. We have examined the Joint Commission application and all subsequent submissions to determine equivalency with our requirements under subpart E of part 493 that an accreditation organization must meet to be approved under CLIA. We have determined that the Joint Commission complied with the applicable CLIA requirements and grant the Joint Commission deeming authority as an accreditation organization under subpart E, for the period stated in the “Effective Date” section of this notice for all specialty and subspecialty areas under CLIA. As a result of this determination, any laboratory that is accredited by the Joint Commission during the effective time period for an approved specialty or subspecialty is deemed to meet the CLIA requirements for the laboratories found in part 493 of our regulations and, therefore, is not subject to routine inspection by a State survey agency to determine its compliance with CLIA requirements. The accredited laboratory, however, is subject to validation and complaint investigation surveys performed by us, or by any other validly authorized agent. III. Evaluation of the Joint Commission Request for Approval as an Accreditation Organization Under CLIA The following describes the process used to determine that requirements of the Joint Commission accreditation program are equal to or more stringent than the CLIA condition level requirements, and that the Joint Commission has met requirements of subpart E of 42 CFR part 493. The Joint Commission formally reapplied to us for approval as an accreditation organization under CLIA for all specialties and subspecialties. We evaluated the Joint Commission application to determine compliance with our implementing and enforcement regulations, and the deeming/exemption requirements of the CLIA rules. We verified that the Joint Commission accreditation program requirements and methods require the laboratories it accredits to be, and that the organization meets or exceeds the following subparts of part 493 as explained below: Subpart E—Accreditation by a Private, Nonprofit Accreditation Organization or Exemption Under an Approved State Laboratory Program The Joint Commission submitted the specialties and subspecialties that it would accredit; a comparison of individual accreditation and condition level requirements; a description of its inspection process; proficiency testing

(PT)monitoring process; its data management and analysis system; a listing of the size, composition, education and experience of its inspection teams; its investigative and complaint response procedures; its notification agreements with us; its removal or withdrawal of laboratory accreditation procedures; its current list of accredited laboratories; and its announced or unannounced inspection process. Our evaluation identified Joint Commission requirements pertaining to waived testing that are more stringent than the CLIA requirements. The Joint Commission waived testing requirements include the following: • Defining the extent that waived test results are used in patient care. • Identifying the personnel responsible for performing and supervising waived testing. • Assuring that personnel performing waived testing have adequate, specific training and orientation to perform the testing and can demonstrate satisfactory levels of performance. • Making certain that policies and procedures governing waived testing-related processes are current and readily available. • Conducting defined quality control checks. • Maintaining quality control and test records. The CLIA requirements at § 493.15 only require that a laboratory follow manufacturer's instructions and obtain a certificate of waiver. Subpart H—Participation in Proficiency Testing for Laboratories Performing Nonwaived Testing The Joint Commission's requirements are equal to the CLIA requirements at § 493.801 through § 493.865. Subpart J—Facility Administration for Nonwaived Testing The Joint Commission requirements are equal to the CLIA requirements at § 493.1100 through § 493.1105. Subpart K—Quality System for Nonwaived Testing The Joint Commission requirements are equal to or more stringent than the CLIA requirements at § 493.1200 through § 493.1299. We have determined that Joint Commission's requirements, when taken as a whole, are more stringent than the CLIA requirements. For instance, the Joint Commission has control procedure requirements for all waived complexity testing performed. Subpart M—Personnel for Nonwaived Testing We have determined that the Joint Commission requirements are equal to or more stringent than the CLIA requirements at § 493.1403 through § 493.1495 for laboratories that perform moderate and high complexity testing. Subpart Q—Inspections We have determined that the Joint Commission requirements are equal to or more stringent than the CLIA requirements at § 493.1771 through § 493.1780. The Joint Commission will continue to perform onsite inspections every 2 years. Subpart R—Enforcement Procedures The Joint Commssion meets the requirements of subpart R to the extent that it applies to accreditation organizations. The Joint Commission policy sets forth the actions the organization takes when laboratories it accredits do not comply with its requirements and standards for accreditation. When appropriate, the Joint Commission will deny, suspend, or, revoke accreditation in a laboratory accredited by the Joint Commission and report that action to us within 30 days. The Joint Commission also provides an appeal process for laboratories that have had accreditation denied, suspended, or revoked. We have determined that the Joint Commission's laboratory enforcement and appeal policies are equal to or more stringent than the requirements of part 493 subpart R as they apply to accreditation organizations. IV. Federal Validation Inspections and Continuing Oversight The Federal validation inspections of Joint Commission accredited laboratories may be conducted on a representative sample basis or in response to substantial allegations of noncompliance (that is, complaint inspections). The outcome of those validation inspections, performed by us or our agents, or the State survey agencies, will be our principal means for verifying that the laboratories accredited by the Joint Commission remain in compliance with CLIA requirements. This Federal monitoring is an ongoing process. V. Removal of Approval as an Accrediting Organization Our regulations provide that we may rescind the approval of an accreditation organization, such as that of the Joint Commission, for cause, before the end of the effective date of approval. If we determine that the Joint Commission failed to adopt requirements that are equal to, or more stringent than, the CLIA requirements, or that systemic problems exist in its inspection process, we may give it a probationary period, not to exceed 1 year to allow the Joint Commission to adopt comparable requirements. Should circumstances result in our withdrawal of the Joint Commission's approval, we will publish a notice in the **Federal Register** explaining the basis for removing its approval. VI. Collection of Information Requirements This notice does not impose any information collection and record keeping requirements subject to the Paperwork Reduction Act (PRA). Consequently, it does not need to be reviewed by the Office of Management and Budget

(OMB)under the authority of the PRA. The requirements associated with the accreditation process for clinical laboratories under the Clinical Laboratory Improvement Amendments of 1988

(CLIA)program, codified in 42 CFR part 493 subpart E, are currently approved by OMB under OMB approval number 0938-0686. VII. Executive Order 12866 Statement In accordance with the provisions of Executive Order 12866, this notice was not reviewed by the Office of Management and Budget. Authority: Section 353 of the Public Health Service Act (42 U.S.C. 263a). Dated: December 7, 2006. Leslie V. Norwalk, Acting Administrator, Centers for Medicare & Medicaid Services. [FR Doc. E7-3030 Filed 2-22-07; 8:45 am] BILLING CODE 4120-01-P DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Medicare & Medicaid Services [CMS-1391-NC] Medicare and Medicaid Programs; Announcement of an Application From a Hospital Requesting Waiver for Organ Procurement Service Area AGENCY: Centers for Medicare & Medicaid Services (CMS), HHS. ACTION: Notice with comment period. SUMMARY: This notice announces a hospital's request for a waiver from entering into an agreement with its designated organ procurement organization (OPO), in accordance with section 1138(a)(2) of the Social Security Act (the Act). This notice requests comments from OPOs and the general public for our consideration in determining whether we should grant the requested waiver. DATES: *Comment Date:* To be assured consideration, comments must be received at one of the addresses provided below, no later than 5 p.m. on April 24, 2007. ADDRESSES: In commenting, please refer to file code CMS-1391-NC. 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 specific issues in this regulation to *http://www.cms.hhs.gov/eRulemaking.* Click on the link “Submit electronic comments on CMS regulations with an open comment period.” (Attachments should be in Microsoft Word, WordPerfect, or Excel; however, we prefer Microsoft Word.) 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-1391-NC, P.O. Box 8017, Baltimore, MD 21244-8017. 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-1391-NC, 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 one of the following addresses. 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. Room 445-G, Hubert H. Humphrey Building, 200 Independence Avenue, SW., Washington, DC 20201; or 7500 Security Boulevard, Baltimore, MD 21244-1850. (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.) Comments mailed to the addresses indicated as appropriate for hand or courier delivery may be delayed and received after the comment period. FOR FURTHER INFORMATION CONTACT: Mark A. Horney,

(410)786-4554. SUPPLEMENTARY INFORMATION: *Submitting Comments:* We welcome comments from the public on all issues set forth in this proposed notice to assist us in fully considering the issues. You can assist us by referencing the file code CMS-1391-NC and the specific “issue identifier” that precedes the section on which you choose to comment. *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 electronic comments received before the close of the comment period on its public Web site as soon as possible after they have been received: *http://www.cms.hhs.gov/eRulemaking.* Click on the link “Electronic Comments on CMS Regulations” 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 [If you choose to comment on issues in this section, please include the caption “BACKGROUND” at the beginning of your comments.] Organ Procurement Organizations

(OPOs)are not-for-profit organizations that are responsible for the procurement, preservation, and transport of transplantable organs to transplant centers throughout the country. Qualified OPOs are designated by the Centers for Medicare & Medicaid Services

(CMS)to recover or procur organs in CMS-defined exclusive geographic service areas, according to section 371(b)(1)(F) of the Public Health Service Act (42 U.S.C. 273(b)(1)(F)) and our regulations at 42 CFR 486.306. Once an OPO has been designated for an area, hospitals in that area that participate in Medicare and Medicaid are required to work with that OPO in providing organs for transplant, according to section 1138(a)(1)(C) of the Social Security Act (the Act), and our regulations at 42 CFR 482.45. Section 1138(a)(1)(A)(iii) of the Act provides that a hospital must notify the designated OPO (for the service area in which it is located) of potential organ donors. Under section 1138(a)(1)(C) of the Act, every participating hospital must have an agreement to identify potential donors only with its designated OPO. However, section 1138(a)(2)(A) of the Act provides that a hospital may obtain from the Secretary, a waiver of the above requirements under certain specified conditions. A waiver allows the hospital to have an agreement with an OPO other than the one initially designated by CMS, if the hospital meets certain conditions specified in section 1138(a)(2)(A) of the Act. In addition, the Secretary may review additional criteria described in section 1138(a)(2)(B) of the Act to evaluate the hospital's request for a waiver. Section 1138(a)(2)(A) of the Act states that in granting a waiver, the Secretary must determine that the waiver—(1) is expected to increase organ donations; and

(2)will ensure equitable treatment of patients referred for transplants within the service area served by the designated OPO and within the service area served by the OPO with which the hospital seeks to enter into an agreement under the waiver. In making a waiver determination, section 1138(a)(2)(B) of the Act provides that the Secretary may consider, among other factors:

(1)Cost-effectiveness;

(2)improvements in quality;

(3)whether there has been any change in a hospital's designated OPO due to the changes made in definitions for metropolitan statistical areas; and

(4)the length and continuity of a hospital's relationship with an OPO other than the hospital's designated OPO. Under section 1138(a)(2)(D) of the Act, the Secretary is required to publish a notice of any waiver application received from a hospital within 30 days of receiving the application, and to offer interested parties an opportunity to comment in writing during the 60-day period beginning on the publication date in the **Federal Register** . The criteria that the Secretary uses to evaluate the waiver in these cases are the same as those described above under sections 1138(a)(2)(A) and

(B)of the Act and have been incorporated into the regulations at 42 CFR 486.308(e) and (f). II. Waiver Request Procedures [If you choose to comment on issues in this section, please include the caption “Waiver Request Procedures” at the beginning of your comments.] In October 1995, we issued a Program Memorandum (Transmittal No. A-95- 11) detailing the waiver process and discussing the information that hospitals must provide in requesting a waiver. We indicated that upon receipt of a waiver request, we would publish a **Federal Register** notice to solicit public comments, as required by section 1138(a)(2)(D) of the Act. According to these requirements, we will review the request and comments received. During the review process, we may consult on an as-needed basis with the Public Health Service's Division of Transplantation, the United Network for Organ Sharing, and our regional offices. If necessary, we may request additional clarifying information from the applying hospital or others. We will then make a final determination on the waiver request and notify the hospital and the designated and requested OPOs. III. Hospital Waiver Request [If you choose to comment on issues in this section, please include the caption “Hospital Waiver Request” at the beginning of your comments.] As permitted by 42 CFR 486.308(e), Methodist Hospital, of Henderson, Kentucky has requested a waiver in order to enter into an agreement with a designated OPO other than the OPO designated for the service area in which the hospital is located. *Methodist Hospital is requesting a waiver to work with:* Kentucky Organ Donor Affiliates, 106 East Broadway, Louisville, Kentucky 40202. *Methodist Hospital's Designated OPO is:* Indiana Organ Procurement Organization, 429 N. Pennsylvania, Suite 201, Indianapolis, Indiana 46204. Authority: Section 1138 of the Social Security Act (42 U.S.C. 1320b-8). (Catalog of Federal Domestic Assistance Program No. 93.773, Medicare—Hospital Insurance; Program No. 93.774, Medicare—Supplementary Medical Insurance, and Program No. 93.778, Medical Assistance Program) Dated: February 15, 2007. Leslie V. Norwalk, Acting Administrator, Centers for Medicare & Medicaid Services. [FR Doc. E7-3044 Filed 2-22-07; 8:45 am] BILLING CODE 4120-01-P DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Medicare & Medicaid Services [CMS-1553-N] Medicare Program; Notice of Supplemental Election Period for Provider Participation in the Calendar Year

(CY)2007 Competitive Acquisition Plan for Part B Drugs AGENCY: Centers for Medicare & Medicaid Services (CMS), HHS. ACTION: Notice. SUMMARY: This notice announces an additional physician election period for physicians who are not currently participating in the competitive acquisition program

(CAP)for Medicare Part B drugs for calendar year

(CY)2007. The additional physician election period begins on May 1, 2007 and ends on June 15, 2007. Physicians who elect to join the CAP during this additional election period will enter into a physician election agreement effective August 1, 2007 through December 31, 2007. DATES: The additional CAP physician election period will begin on May 1, 2007 and end on June 15, 2007. Physicians electing to join the CAP during this period will participate in the CAP effective August 1, 2007. FOR FURTHER INFORMATION CONTACT: Edmund Kasaitis

(410)786-4545. SUPPLEMENTARY INFORMATION: I. Background The Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (Pub. L. 108-173)

(MMA)requires the implementation of a competitive acquisition program

(CAP)for certain Medicare Part B drugs not paid on a cost or prospective payment system basis. Physicians who elect to participate in the CAP obtain Medicare covered drugs from vendors selected through a competitive bidding process. Physicians who do not elect to participate in the CAP purchase these drugs and are paid under the average sales price

(ASP)system. (For more information on the CAP, see the March 4, 2005 proposed rule (70 FR 10746), July 6, 2005 interim final rule with comment period (70 FR 39022), and November 21, 2005 final rule (70 FR 70116).) In accordance with the CAP statute and regulations, the regular, annual CAP physician election period for CY 2008 will occur in the fall of 2007. II. Provisions of the Notice Under the authority described in section 1847B(a)(5)(A)(i) of Social Security Act (the Act) and § 414.908(a)(2) of our regulations, which allows for physician election at times other than the regular, annual election period in such exigent circumstances as defined by CMS, we are designating an additional election period for physicians who wish to join the CAP. We are providing for this additional election period in recognition of the statutory change to the CAP under division B, title I, section 108 of the Tax Relief and Health Care Act of 2006 (Pub. L. 109-432) (TRHCA), effective for drugs supplied under the CAP as of April 1, 2007. We expect to provide program instructions or other guidance in the near future to implement changes to the CAP resulting from the new statutory provisions. Although the statutory change does not directly affect participating CAP physicians, it will require additional implementation efforts by CMS and was enacted after the close of the CAP physician election period for CY 2007. Thus, we believe this is an “exigent circumstance” for which we should allow physicians an additional opportunity to join the CAP. The additional election period— • Begins May 1, 2007 and end June 15, 2007; and • Is only for physicians as defined in section 1861(r) of the Act who are not currently participating in the CY 2007 CAP. The procedures and forms used for the regular, annual election period for CY 2007 also will be used for this additional CY 2007 election period. The aforementioned forms include the Competitive Acquisition Program

(CAP)for Medicare Part B Drugs CAP Physician Election Agreement, which is currently approved under the Office of Management and Budget control number 0938-0987, with an expiration date of April 30, 2009. Physicians who wish to join the CAP during this election period may obtain a Physician Election Agreement form from the download section of the CAP Information for Physicians webpage on the CMS Web site at *http://www.cms.hhs.gov/CompetitiveAcquisforBios/02_infophys.asp#TopOfPage* . Physicians who elect to participate in the CAP during the additional CY 2007 election period will have their CAP election agreement effective from August 1, 2007 through December 31, 2007. We note that participation in the CAP for CY 2008 requires renewal of CAP election during the regular fall election period, which will run from October 1, 2007 to November 15, 2007. Completed and signed forms must be returned by mail to the physician's local carrier (the carrier that processes the physician's Part B claims). Forms must be postmarked no later than June 15, 2007. Additional details about CAP physician election will be available on the CMS Web site at *http://www.cms.hhs.gov/CompetitiveAcquisforBios/02_infophys.asp#TopOfPage* . Authority: Section 1847B(a)(5)(A)(i) of the Social Security Act (42 U.S.C.) (No. 93.774, Medicare—Supplementary Medical Insurance Program). Dated: February 15, 2007. Leslie V. Norwalk, Acting Administrator, Centers for Medicare & Medicaid Services. [FR Doc. E7-3037 Filed 2-22-07; 8:45 am] BILLING CODE 4120-01-P DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Medicare & Medicaid Services [CMS-1544-N] Program; Public Meetings in Calendar Year 2007 for All New Public Requests for Revisions to the Healthcare Common Procedure Coding System (HCPCS) Coding and Payment Determinations AGENCY: Centers for Medicare & Medicaid Services (CMS), HHS. ACTION: Notice. SUMMARY: This notice announces the dates, time, and location of the Healthcare Common Procedure Coding System (HCPCS) public meetings to be held in calendar year 2007 to discuss our preliminary coding and payment determinations for all new public requests for revisions to the HCPCS. These meetings provide a forum for interested parties to make oral presentations or to submit written comments in response to preliminary coding and payment determinations. Discussion will be directed toward responses to our specific preliminary recommendations and will include all items on the public meeting agenda. DATES: *Meeting Dates:* The following are the 2007 HCPCS public meeting dates: 1. Tuesday, May 1, 2007, 9 a.m. to 5 p.m., e.s.t. (Supplies and Other) 2. Wednesday, May 2, 2007, 9 a.m. to 5 p.m., e.s.t. (Supplies and Other) 3. Thursday, May 3, 2007, 9 a.m. to 5 p.m., e.s.t. (Durable Medical Equipment

(DME)and Accessories). 4. Tuesday, May 15, 2007, 9 a.m. to 5 p.m., e.s.t. (Drugs/Biologicals/Radiopharmaceuticals/Radiologic Imaging Agents) 5. Wednesday, May 16, 2007, 9 a.m. to 5 p.m., e.s.t. (Drugs/Biologicals/Radiopharmaceuticals/Radiologic Imaging Agents) 6. Tuesday, May 22, 2007, 9 a.m. to 5 p.m., e.s.t. (Orthotics and Prosthetics) 7. Wednesday, May 23, 2007, 9 a.m. to 5 p.m., e.s.t. (Orthotics and Prosthetics) The product category reported by the meeting participant may not be the same as that assigned by CMS. All meeting participants are advised to review the public meeting agenda at *http://www.cms.hhs.gov/medhcpcsgeninfo* which identifies our category determinations, and the dates each item will be discussed. Draft agendas, including a summary of each request and CMS' preliminary decision will be posted on our HCPCS Web site at *http://www.cms.hhs.gov/medhcpcsgeninfo* at least 1 month before each meeting. *Registration Deadlines:* Individuals must register for each date they plan either to attend or to provide a presentation. For the May 1, 2, and 3, 2007 public meeting dates, the deadline for registration is April 24, 2007; for the May 15 and 16, 2007 public meeting, the deadline for registration is May 8, 2007; for the May 22 and 23, 2007 public meetings, the deadline for registration is May 15, 2007. *Deadlines for Submission of Supporting Material:* The deadline for submitting materials and writings that will be used in support of an oral presentation are: Public meetings held on May 1, 2, and 3, 2007, the deadline is April 17, 2007; public meetings held on May 15 and 16, 2007, the deadline is May 1, 2007; public meeting held on May 22 and 23, 2007, the deadline is May 8, 2007. ADDRESSES: *Meeting Location:* The public meetings will be held in the main auditorium of the central building of the Centers for Medicare and Medicaid Services, 7500 Security Boulevard, Baltimore, MD 21244-1850 *Registration and Special Accommodations:* Individuals wishing to participate or who need special accommodations or both must register by completing the on-line registration located at *http://www.cms.hhs.gov/medhcpcsgeninfo;* or by contacting Felicia Eggleston at (410)786-9287; *felicia.eggleston@cms.hhs.gov* or Gloria Knight at (410)786-4598; *Gloria.Knight@cms.hhs.gov* , for the meetings for May 1, May 2, May 3, 2007 meetings. For the May 15, May 16, May 22, and May 23, 2007 meetings, contact Jennifer Carver at (410)786-6610; *Jennifer.Carver@cms.hhs.gov* or Trish Brooks at (410)786-4561; *Trish.Brooks@cms.hhs.gov.* FOR FURTHER INFORMATION CONTACT: Jennifer Carver, 410-786-6610 or *Jennifer.carver@cms.hhs.gov.* SUPPLEMENTARY INFORMATION: I. Background On December 21, 2000, the Congress passed the Medicare, Medicaid, and SCHIP Benefits Improvement and Protection Act of 2000

(BIPA)(Pub. L. 106-554). Section 531(b) of BIPA mandated that we establish procedures that permit public consultation for coding and payment determinations for new durable medical equipment

(DME)under Medicare Part B of title XVIII of the Social Security Act (the Act). The procedures and public meetings announced in this notice for new DME are in response to the mandate of section 531(b) of BIPA. We published a notice in the November 23, 2001 **Federal Register** (66 FR 58743) providing information regarding the establishment of the public meeting process for DME. It is our intent to distribute any materials submitted to CMS to the HCPCS workgroup members for their consideration. CMS and the HCPCS workgroup members require sufficient preparation time to review all relevant materials. For this reason, our HCPCS Public Meeting Coordinators will only accept and review presentation materials received by the deadline for each public meeting, as specified in the DATES section. Therefore, we are implementing a 10-page submission limit and firm deadlines for receipt of any materials and presentations the meeting participant wishes CMS to consider. The public meeting process provides an opportunity for the public to become aware of coding changes under consideration, as well as an opportunity for CMS to gather public input. II. Meeting Registration The following information must be provided when registering: Name, company name and address, telephone and fax numbers, e-mail address, and special needs information. A CMS staff member will confirm your registration by mail, e-mail, or fax. A. Registration Process for Primary Speakers Individuals must also indicate whether they are the “primary speaker” for an agenda item. Primary speakers must be designated by the entity that submitted the HCPCS coding request. When registering, primary speakers must provide a brief written statement regarding the nature of the information they intend to provide, and advise the HCPCS Public Meeting Coordinator regarding needs for audio/visual support. To avoid disruption of the meeting and ensure compatibility with our systems, tapes and disk files are tested and arranged in speaker sequence well in advance of the meeting. We will accept tapes and disk files that are received by the “Submission Deadline” for each public meeting, as specified in the DATES section of this notice. The sum of all materials including presentation may not exceed 10 pages (each side of a page counts as 1 page). An exception will be made to the 10-page limit for relevant studies published between the application deadline and the public meeting date, in which case, we would like a copy of the complete publication as soon as possible. These materials may be delivered by regular mail or by e-mail to the respective HCPCS Public Meeting Coordinators as specified in the ADDRESSES section. Individuals will need to provide 35 copies if materials are delivered by mail. B. Registration Process for 5-Minute Speakers In order to afford the same opportunity to all attendees, there is no pre-registration for 5-minute speakers. Attendees can sign up only on the day of the meeting to do a 5-minute presentation. They must provide their name, company name and address, contact information as specified on the sign-up sheet, and identify the specific agenda item that they will address. C. Additional Registration Information Additional details regarding the public meeting process for all new public requests for revisions to the HCPCS, along with information on how to register and guidelines for an effective presentation, will be posted at least 1 month before the first meeting date on the HCPCS Web site: *http://www.cms.hhs.gov/medhcpcsgeninfo* . Individuals who intend to provide a presentation at a public meeting need to familiarize themselves with the HCPCS Web site and the valuable information it provides to prospective registrants. The HCPCS Web site, also contains a document titled “The Healthcare Common Procedure Coding System (HCPCS) Level II Coding Procedures,” which is a description of the HCPCS coding process, including a detailed explanation of the procedures used to make coding and payment determinations for all the products, supplies, and services that are coded in the HCPCS. A summary of each public meeting will be posted on the HCPCS Web site by the end of August 2007. III. Presentations and Comment Format We can only estimate the amount of meeting time that will be needed since it is difficult to anticipate the total number of speakers for each meeting. Meeting participants should arrive early since each meeting is anticipated to begin promptly at 9 a.m. Speakers need to arrive prepared and wait until it is their turn to speak. Meetings may end earlier than the stated ending time. A. Oral Presentation Procedures Individuals who are planning to provide an oral presentation must register as provided under the section titled “Meeting Registration.” Materials and writings that will be used in support of an oral presentation should be submitted to the HCPCS Public Meeting Coordinators as specified in the DATES section. These materials may be delivered by regular mail (postmark date no later than deadline date) or by e-mail to the respective HCPCS Public Meeting Coordinators specified in the ADDRESSES section. Individuals will need to include 35 copies if materials are delivered by mail. B. Primary Speaker Presentations The individual or entity requesting revisions to the HCPCS coding system for a particular agenda item may designate one “primary speaker” to make a presentation for a maximum of 15 minutes. Fifteen minutes is the total time interval for the presentation, and the presentation must incorporate the demonstration, set-up, and distribution of material. In establishing the public meeting agenda, we may group multiple, related requests under the same agenda item. In that case, we will decide whether additional time will be allotted, and may opt to increase the amount of time allotted to the speaker by increments of less than 15 minutes. We will post “Guidelines for Participation in Public Meetings for All New Public Requests for Revisions to the Healthcare Common Procedure Coding System (HCPCS) Coding and Payment Determinations” on the official HCPCS Web site at least a month before the first public meeting in 2007 for all new public requests for revisions to the HCPCS. Individuals designated to be the primary speaker must register to attend the meeting using the registration procedures described under the section titled “Meeting Registration” and, at least 15 days before the meeting, contact the appropriate HCPCS Public Meeting Coordinators, specified in the ADDRESSES section. C. “5-Minute” Speaker Presentations Meeting attendees can sign up at the meeting, on a first-come, first-served basis, to make 5-minute presentations on individual agenda items. Based on the number of items on the agenda and the progress of the meeting, a determination will be made at the meeting by the meeting coordinator and the meeting moderator regarding how many 5-minute speakers can be accommodated. D. Speaker Declaration On the day of the meeting, before the end of the meeting, all primary speakers and 5-minute speakers must provide a brief written summary of their comments and conclusions to the HCPCS Public Meeting Coordinator. The primary speakers and the 5-minute speakers must declare in their presentations at the meeting, as well as in their written summaries, whether they have any financial involvement with the manufacturers or competitors of any items or services being discussed; this includes any payment, salary, remuneration, or benefit provided to that speaker by the manufacturer or the manufacturer's representatives. E. Written Comments From Meeting Attendees Written comments can be submitted either the before or at the meeting via e-mail to *http://www.cms.hhs.gov/medhcpcsgeninfo* or via regular mail to the HCPCS Public Meeting Coordinator, Centers for Medicare & Medicaid Services, 7500 Security Boulevard, Mail Stop C5-08-27, Baltimore, MD 21244. Due to the close timing of the public meetings, subsequent workgroup reconsiderations, and final decisions, we are able to consider only those comments received in writing by the close of the public meeting at which the request is discussed. Written comments to this address are also accepted from the general public anytime up to the date of the public meeting at which a request is discussed. IV. Security, Building, and Parking Guidelines The meetings are held in a Federal government building; therefore, Federal security measures are applicable. In planning your arrival time, we recommend allowing additional time to clear security. In order to gain access to the building and grounds, participants must bring government-issued photo identification and a copy of your written meeting registration confirmation. Persons without proper identification will be denied access. 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 45 minutes before the convening of the meeting each day. Security measures will also include inspection of vehicles, inside and outside, at the entrance to the grounds and buildings. In addition, all persons entering the building must pass through a metal detector. All items brought to CMS 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 demonstration or to support a presentation. Special arrangements and approvals are required in order to bring pieces of equipment or medical devices at least two weeks prior to each public meeting. These arrangements need to be made with the appropriate public meeting coordinator. It is possible that certain requests, made in advance, of the public meeting could be denied because of unique safety, security or handling issues related to the equipment. A minimum of two weeks is required for approvals and security procedures. Any request not submitted at least two weeks in advance of the public meeting will be denied. Parking permits and instructions are issued upon arrival by the guards at the main entrance. All visitors must be escorted in areas other than the lower and first-floor levels in the Central Building. Authority: Section 1102 and 1871 of the Social Security Act (42 U.S.C. 1302 and 42 U.S.C. 1395hh). Dated: January 29, 2007. Leslie V. Norwalk, Acting Administrator, Centers for Medicare & Medicaid Services. [FR Doc. E7-3034 Filed 2-22-07; 8:45 am] BILLING CODE 4120-01-P DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Medicare & Medicaid Services [CMS-1383-N2] Medicare Program; Listening Session on the Draft Plan for Medicare Hospital Value-Based Purchasing—April 12, 2007 AGENCY: Centers for Medicare & Medicaid Services (CMS), HHS. ACTION: Notice of meeting. SUMMARY: This notice announces the second Listening Session being conducted as part of the development of a plan for Medicare hospital value-based purchasing, as authorized by section 5001(b) of the Deficit Reduction Act of 2005 (Pub. L. 109-171) (DRA). The purpose of the second Listening Session is to solicit comments on the Draft Plan that has been developed. Hospitals, hospital associations, and all interested parties are invited to attend and make comments in person. The perspectives expressed during this session and in writing will assist us in making revisions to the Draft Plan to create the final Medicare Hospital Value-Based Purchasing Plan to be completed by June 2007. The Draft Plan will be posted no later than March 22, 2007 on the CMS Web site, Hospital Center, under Spotlights at *http://www.cms.hhs.gov/center/hospital.asp.* DATES: *Meeting Date:* The listening session will be held on Thursday, April 12, 2007 from 10 a.m. until 5 p.m. e.d.t. *Registration and Request for Special Accommodations Deadline:* Registration will open February 26, 2007. For security reasons, registration must be completed no later than 5 p.m. e.d.t. on Thursday, April 9, 2007. Requests for special accommodations must be received by 5 p.m. e.d.t. on Thursday, April 9, 2007. See Section III. below for detailed instructions. *Deadline for Submission of Written Comments or Statements:* Written comments on the Draft Plan may be sent by mail, fax, or electronically and must be received by 5 p.m. e.d.t. on April 19, 2007. ADDRESSES: *Meeting Location:* The Listening Session will be held in the main auditorium of the central building of the Centers for Medicare and Medicaid Services, 7500 Security Boulevard, Baltimore, MD 21244-1850. *Registration and Special Accommodations:* Persons interested in attending the meeting or listening by teleconference must register by completing the on-line registration located at *http://registration.mshow.com/cms2/.* Individuals who need special accommodations should contact Robin Phillips at

(410)786-3010, by e-mail to *robin.phillips@cms.hhs.gov* , or by regular mail to Mail Stop C4-13-07 Centers for Medicare & Medicaid Services, 7500 Security Boulevard, Baltimore, MD 21244-1850. *Written Comments or Statements:* Written comments on the Draft Plan may be mailed to Mail Stop C4-13-07 Centers for Medicare and Medicaid Services, 7500 Security Boulevard, Baltimore, MD 21244; e-mail to *cmshospitalVBP@cms.hhs.gov* or fax to 410-786-0330. FOR FURTHER INFORMATION CONTACT: Robin Phillips, 410-786-3010 in the Medicare Feedback Group. You may also send inquires about this meeting via e-mail to *robin.phillips@cms.hhs.gov.* SUPPLEMENTARY INFORMATION: I. Background Section 5001(b) of the Deficit Reduction Act of 2005 (Pub. L. 109-171)

(DRA)specifies that we develop a plan to implement a Value-Based Purchasing

(VBP)Program for payments under the Medicare program for subsection

(d)hospitals (as defined in section 1886(d)(1)(B) of the Social Security Act) beginning with FY 2009. The Congress specified that the “plan” include consideration of the following issues: • The ongoing development, selection, and modification process for measures of quality and efficiency in hospital inpatient settings. • The reporting, collection, and validation of quality data. • The structure of value-based payment adjustments, including the determination of thresholds or improvements in quality that would substantiate a payment adjustment, the size of such payments, and the sources of funding for the value-based payments. • The disclosure of information on hospital performance. In developing the plan, we must consult with relevant affected parties and consider experience with demonstrations that are relevant to the VBP program. We have created an internal Hospital Pay-for-Performance Workgroup that is charged with developing the VBP Plan for Medicare hospital services. This Workgroup is organized into four subgroups to address each of the required planning issues:

(1)Measures;

(2)data collection and validation;

(3)incentive structure; and

(4)public reporting. It is also charged with preparing a set of design options, narrowing the set of design options to prepare a draft plan, and preparing a report on the plan for implementing VBP for Medicare hospital services, which will be provided to the Congress as required under section 5001(b)(3) of the DRA. In the November 24, 2006 **Federal Register** , we announced that we would have a listening session to consider design questions posed in the Issues Paper that we posted on our Web site *http://www.cms.hhs.gov.* This listening session was held on January 17, 2007. II. Listening Session Format and Agenda The second listening session will be held on April 12, 2007 to consider the Draft Plan. This listening session will begin at 10 a.m. with an overview of the objectives for the session and a brief summary of the approach to developing the Draft Plan. Beginning at approximately 10:30 a.m., the remainder of the meeting will be devoted to addressing each section of the Plan. The agenda will provide opportunities for brief 2-minute comments from on-site session attendees. As time allows, telephone participants will also have the opportunity to provide brief 2-minute comments. A lunch break will occur from approximately 12:30 p.m. to 1:30 p.m. The meeting will conclude by 5 p.m. with brief comments on “next steps.” III. Registration Instructions Persons interested in attending the meeting or listening by teleconference must register by completing the on-line registration located at *http://registration.mshow.com/cms2/.* The on-line registration system will generate a confirmation page to indicate the completion of your registration. Please print this page as your registration receipt. Individuals may also participate in the listening session by teleconference. Registration is required. The call-in number will be provided upon confirmation of registration. An audio download of the listening session will be available through the CMS Hospital Center Web site within 72 hours after completion of the listening session. IV. 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 April 9, 2007. 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 550 registrants. The on-site check-in for visitors will begin at 9:15 a.m. Please allow sufficient time to go through the security checkpoints at both the entrance to the grounds and the entrance to the building. It is suggested that you arrive at central building by 9 a.m. so that you will have enough time to check-in before the session begins. Security measures will include inspection of vehicles, inside and out, at the entrance to the grounds. In addition, all persons entering the building must check in by name with Security, provide a government-issued ID, and pass through a metal detector. All items brought to the building, whether personal or for the purpose of demonstration or to support a presentation, including items such as laptops, cell phones, and palm pilots, are subject to physical inspection. Authority: Section 5001(b) The Deficit Reduction Act

(DRA)of 2005. Dated: February 15, 2007. Leslie V. Norwalk, Acting Administrator, Centers for Medicare & Medicaid Services. [FR Doc. E7-3048 Filed 2-22-07; 8:45 am] BILLING CODE 4120-01-P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 2006E-0261] Determination of Regulatory Review Period for Purposes of Patent Extension; EXJADE AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration

(FDA)has determined the regulatory review period for EXJADE and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of Patents and Trademarks, Department of Commerce, for the extension of a patent that claims that human drug product. ADDRESSES: Submit written comments and petitions to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments to *http://www.fda.gov/dockets/ecomments* . FOR FURTHER INFORMATION CONTACT: Beverly Friedman, Office of Regulatory Policy (HFD-7), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-594-2041. SUPPLEMENTARY INFORMATION: The Drug Price Competition and Patent Term Restoration Act of 1984 (Public Law 98-417) and the Generic Animal Drug and Patent Term Restoration Act (Public Law 100-670) generally provide that a patent may be extended for a period of up to 5 years so long as the patented item (human drug product, animal drug product, medical device, food additive, or color additive) was subject to regulatory review by FDA before the item was marketed. Under these acts, a product's regulatory review period forms the basis for determining the amount of extension an applicant may receive. A regulatory review period consists of two periods of time: a testing phase and an approval phase. For human drug products, the testing phase begins when the exemption to permit the clinical investigations of the human drug product becomes effective and runs until the approval phase begins. The approval phase starts with the initial submission of an application to market the human drug product and continues until FDA grants permission to market the product. Although only a portion of a regulatory review period may count toward the actual amount of extension that the Director of Patents and Trademarks may award (for example, half the testing phase must be subtracted, as well as any time that may have occurred before the patent was issued), FDA's determination of the length of a regulatory review period for a human drug product will include all of the testing phase and approval phase as specified in 35 U.S.C. 156(g)(1)(B). FDA recently approved for marketing the human drug product EXJADE (deferasirox). EXJADE is indicated for the treatment of chronic iron overload due to blood transfusions (transfusional hemosiderosis) in patients 2 years of age and older. Subsequent to this approval, the Patent and Trademark Office received a patent term restoration application for EXJADE (U.S. Patent No. 6,465,504) from Novartis AG, and the Patent and Trademark Office requested FDA's assistance in determining this patent's eligibility for patent term restoration. In a letter dated July 24, 2006, FDA advised the Patent and Trademark Office that this human drug product had undergone a regulatory review period and that the approval of EXJADE represented the first permitted commercial marketing or use of the product. Thereafter, the Patent and Trademark Office requested that FDA determine the product's regulatory review period. FDA has determined that the applicable regulatory review period for EXJADE is 2,288 days. Of this time, 2,103 days occurred during the testing phase of the regulatory review period, while 185 days occurred during the approval phase. These periods of time were derived from the following dates: 1. *The date an exemption under section 505(i) of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 355) became effective* : July 31, 1999. FDA has verified the applicant's claim that the date the investigational new drug application became effective was on July 31, 1999. 2. *The date the application was initially submitted with respect to the human drug product under section 505(b) of the act* : May 2, 2005. FDA has verified the applicant's claim that the new drug application

(NDA)for EXJADE (NDA 21-882) was initially submitted on May 2, 2005. 3. *The date the application was approved* : November 2, 2005. FDA has verified the applicant's claim that NDA 21-882 was approved on November 2, 2005. This determination of the regulatory review period establishes the maximum potential length of a patent extension. However, the U.S. Patent and Trademark Office applies several statutory limitations in its calculations of the actual period for patent extension. In its application for patent extension, this applicant seeks 648 days of patent term extension. Anyone with knowledge that any of the dates as published are incorrect may submit to the Division of Dockets Management (see ADDRESSES ) written or electronic comments and ask for a redetermination by April 24, 2007. Furthermore, any interested person may petition FDA for a determination regarding whether the applicant for extension acted with due diligence during the regulatory review period by August 22, 2007. To meet its burden, the petition must contain sufficient facts to merit an FDA investigation. (See H. Rept. 857, part 1, 98th Cong., 2d sess., pp. 41-42, 1984.) Petitions should be in the format specified in 21 CFR 10.30. Comments and petitions should be submitted to the Division of Dockets Management. Three copies of any mailed information are to be submitted, except that individuals may submit one copy. Comments are to be identified with the docket number found in brackets in the heading of this document. Comments and petitions may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday. Dated: February 3, 2007. Jane A. Axelrad, Associate Director for Policy, Center for Drug Evaluation and Research. [FR Doc. E7-3041 Filed 2-22-07; 8:45 am] BILLING CODE 4160-01-S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 2006E-0356] Determination of Regulatory Review Period for Purposes of Patent Extension; BARACLUDE AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration

(FDA)has determined the regulatory review period for BARACLUDE and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of Patents and Trademarks, Department of Commerce, for the extension of a patent that claims that human drug product. ADDRESSES: Submit written comments and petitions to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments to *http://www.fda.gov/dockets/ecomments* . FOR FURTHER INFORMATION CONTACT: Beverly Friedman, Office of Regulatory Policy (HFD-7), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-594-2041. SUPPLEMENTARY INFORMATION: The Drug Price Competition and Patent Term Restoration Act of 1984 (Public Law 98-417) and the Generic Animal Drug and Patent Term Restoration Act (Public Law 100-670) generally provide that a patent may be extended for a period of up to 5 years so long as the patented item (human drug product, animal drug product, medical device, food additive, or color additive) was subject to regulatory review by FDA before the item was marketed. Under these acts, a product's regulatory review period forms the basis for determining the amount of extension an applicant may receive. A regulatory review period consists of two periods of time: A testing phase and an approval phase. For human drug products, the testing phase begins when the exemption to permit the clinical investigations of the human drug product becomes effective and runs until the approval phase begins. The approval phase starts with the initial submission of an application to market the human drug product and continues until FDA grants permission to market the product. Although only a portion of a regulatory review period may count toward the actual amount of extension that the Director of Patents and Trademarks may award (for example, half the testing phase must be subtracted, as well as any time that may have occurred before the patent was issued), FDA's determination of the length of a regulatory review period for a human drug product will include all of the testing phase and approval phase as specified in 35 U.S.C. 156(g)(1)(B). FDA recently approved for marketing the human drug product BARACLUDE (entecavir). BARACLUDE is indicated for the treatment of chronic hepatitis B virus infection in adults with evidence of active viral replication and either evidence of persistent elevations in serum aminotransferases or histologically active disease. Subsequent to this approval, the Patent and Trademark Office received a patent term restoration application for BARACLUDE (U.S. Patent No. 5,206,244) from Bristol-Myers Squibb Co., and the Patent and Trademark Office requested FDA's assistance in determining this patent's eligibility for patent term restoration. In a letter dated September 5, 2006, FDA advised the Patent and Trademark Office that this human drug product had undergone a regulatory review period and that the approval of BARACLUDE represented the first permitted commercial marketing or use of the product. Shortly thereafter, the Patent and Trademark Office requested that FDA determine the product's regulatory review period. FDA has determined that the applicable regulatory review period for BARACLUDE is 2,993 days. Of this time, 2,811 days occurred during the testing phase of the regulatory review period, while 182 days occurred during the approval phase. These periods of time were derived from the following dates: 1. *The date an exemption under section 505(i) of the Federal Food, Drug, and Cosmetics Act (the act) (21 U.S.C. 355(i)) became effective* : January 19, 1997. FDA has verified the applicant's claim that the date the investigational new drug application became effective was on January 19, 1997. 2. *The date the application was initially submitted with respect to the human drug product under section 505(b) of the act* : September 29, 2004. FDA has verified the applicant's claim that the new drug application

(NDA)for BARACLUDE (NDA 21-797) was initially submitted on September 29, 2004. 3. *The date the application was approved* : March 29, 2005. FDA has verified the applicant's claim that NDA 21-797 was approved on March 29, 2005. This determination of the regulatory review period establishes the maximum potential length of a patent extension. However, the U.S. Patent and Trademark Office applies several statutory limitations in its calculations of the actual period for patent extension. In its application for patent extension, this applicant seeks 1,587 days of patent term extension. Anyone with knowledge that any of the dates as published are incorrect may submit to the Division of Dockets Management (see ADDRESSES ) written or electronic comments and ask for a redetermination by April 24, 2007. Furthermore, any interested person may petition FDA for a determination regarding whether the applicant for extension acted with due diligence during the regulatory review period by August 22, 2007. To meet its burden, the petition must contain sufficient facts to merit an FDA investigation. (See H. Rept. 857, part 1, 98th Cong., 2d sess., pp. 41-42, 1984.) Petitions should be in the format specified in 21 CFR 10.30. Comments and petitions should be submitted to the Division of Dockets Management. Three copies of any mailed information are to be submitted, except that individuals may submit one copy. Comments are to be identified with the docket number found in brackets in the heading of this document. Comments and petitions may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday. Dated: January 25, 2007. Jane A. Axelrad, Associate Director for Policy, Center for Drug Evaluation and Research. [FR Doc. E7-3042 Filed 2-22-07; 8:45 am] BILLING CODE 4160-01-S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket Nos. 2004E-0300, 2004E-0301, 2004E-0302, 2004E-0303, 2004E-0304, 2004E-0306, 2004E-0426, and 2006E-0206] Determination of Regulatory Review Period for Purposes of Patent Extension; S8 OVER-THE-WIRE SYSTEM AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration

(FDA)has determined the regulatory review period for S8 OVER-THE-WIRE SYSTEM and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of applications to the Director of Patents and Trademarks, Department of Commerce, for the extension of a patent which claims that medical device. ADDRESSES: Submit written comments and petitions to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments to *http://www.fda.gov/dockets/ecomments* . FOR FURTHER INFORMATION CONTACT: Beverly Friedman, Office of Regulatory Policy (HFD-7), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-594-2041. SUPPLEMENTARY INFORMATION: The Drug Price Competition and Patent Term Restoration Act of 1984 (Public Law 98-417) and the Generic Animal Drug and Patent Term Restoration Act (Public Law 100-670) generally provide that a patent may be extended for a period of up to 5 years so long as the patented item (human drug product, animal drug product, medical device, food additive, or color additive) was subject to regulatory review by FDA before the item was marketed. Under these acts, a product's regulatory review period forms the basis for determining the amount of extension an applicant may receive. A regulatory review period consists of two periods of time: A testing phase and an approval phase. For medical devices, the testing phase begins with a clinical investigation of the device and runs until the approval phase begins. The approval phase starts with the initial submission of an application to market the device and continues until permission to market the device is granted. Although only a portion of a regulatory review period may count toward the actual amount of extension that the Director of Patents and Trademarks may award (half the testing phase must be subtracted as well as any time that may have occurred before the patent was issued), FDA's determination of the length of a regulatory review period for a medical device will include all of the testing phase and approval phase as specified in 35 U.S.C. 156(g)(3)(B). FDA approved for marketing the medical device, S8 OVER-THE-WIRE SYSTEM. S8 OVER-THE-WIRE SYSTEM is indicated for improving coronary luminal diameter in patients with symptomatic ischemic heart disease due to discrete de novo or restenotic lesions with reference vessel diameters of 3.0—4.0 mm and = 30 mm in length using direct stenting or predilatation. Subsequent to this approval, the Patent and Trademark Office received patent term restoration applications for S8 OVER-THE-WIRE SYSTEM (U.S. Patent Nos. 5,292,331; 5,800,509; 5,836,965; 5,879,382; 5,891,190; 6,159,229; 6,309,402; and 6,344,053) from Medtronic Vascular, and the Patent and Trademark Office requested FDA's assistance in determining the patents' eligibilities for patent term restoration. In letters dated February 24, 2006, and June 14, 2006, FDA advised the Patent and Trademark Office that this medical device had undergone a regulatory review period and that the approval of S8 OVER-THE-WIRE SYSTEM represented the first permitted commercial marketing or use of the product. Thereafter, the Patent and Trademark Office requested that FDA determine the product's regulatory review period. FDA has determined that the applicable regulatory review period for S8 OVER-THE-WIRE SYSTEM is 652 days. Of this time, 477 days occurred during the testing phase of the regulatory review period, while 175 days occurred during the approval phase. These periods of time were derived from the following dates: 1. *The date an exemption under section 520(g) of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 360j(g)) involving this device became effective* : December 20, 2001. FDA has verified the applicant's claim that the date the investigational device exemption

(IDE)required under section 520(g) of the act for human tests to begin became effective December 20, 2001. 2. *The date the application was initially submitted with respect to the device under section 515 of the act (21 U.S.C. 360e)* : April 10, 2003. The applicant claims April 9, 2003, as the date the premarket approval application

(PMA)for S8 OVER-THE-WIRE SYSTEM (PMA P030009) was initially submitted. However, FDA records indicate that PMA P030009 was submitted on April 10, 2003. 3. *The date the application was approved* : October 1, 2003. FDA has verified the applicant's claim that PMA P030009 was approved on October 1, 2003. This determination of the regulatory review period establishes the maximum potential length of a patent extension. However, the U.S. Patent and Trademark Office applies several statutory limitations in its calculations of the actual period for patent extension. In its applications for patent extension, this applicant seeks 413 days of patent term extension. Anyone with knowledge that any of the dates as published is incorrect may submit to the Division of Dockets Management (see ADDRESSES ) written or electronic comments and ask for a redetermination by April 24, 2007. Furthermore, any interested person may petition FDA for a determination regarding whether the applicant for extension acted with due diligence during the regulatory review period by August 22, 2007. To meet its burden, the petition must contain sufficient facts to merit an FDA investigation. (See H. Rept. 857, part 1, 98th Cong., 2d sess., pp. 41-42, 1984.) Petitions should be in the format specified in 21 CFR 10.30. Comments and petitions should be submitted to the Division of Dockets Management. Three copies of any mailed information are to be submitted, except that individuals may submit one copy. Comments are to be identified with the docket number found in brackets in the heading of this document. Comments and petitions may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday. Dated: January 25, 2007. Jane A. Axelrad, Associate Director for Policy, Center for Drug Evaluation and Research. [FR Doc. E7-3127 Filed 2-22-07; 8:45 am] BILLING CODE 4160-01-S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 2006E-0355] Determination of Regulatory Review Period for Purposes of Patent Extension; AMITIZA AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration

(FDA)has determined the regulatory review period for AMITIZA and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of Patents and Trademarks, Department of Commerce, for the extension of a patent which claims that human drug product. ADDRESSES: Submit written comments and petitions to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments to *http://www.fda.gov/dockets/ecomments* . FOR FURTHER INFORMATION CONTACT: Beverly Friedman, Office of Regulatory Policy (HFD-7), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-594-2041. SUPPLEMENTARY INFORMATION: The Drug Price Competition and Patent Term Restoration Act of 1984 (Public Law 98-417) and the Generic Animal Drug and Patent Term Restoration Act (Public Law 100-670) generally provide that a patent may be extended for a period of up to 5 years so long as the patented item (human drug product, animal drug product, medical device, food additive, or color additive) was subject to regulatory review by FDA before the item was marketed. Under these acts, a product's regulatory review period forms the basis for determining the amount of extension an applicant may receive. A regulatory review period consists of two periods of time: A testing phase and an approval phase. For human drug products, the testing phase begins when the exemption to permit the clinical investigations of the human drug product becomes effective and runs until the approval phase begins. The approval phase starts with the initial submission of an application to market the human drug product and continues until FDA grants permission to market the drug product. Although only a portion of a regulatory review period may count toward the actual amount of extension that the Director of Patents and Trademarks may award (for example, half the testing phase must be subtracted, as well as any time that may have occurred before the patent was issued), FDA's determination of the length of a regulatory review period for a human drug product will include all of the testing phase and approval phase as specified in 35 U.S.C. 156(g)(1)(B). FDA recently approved for marketing the human drug product AMITIZA (lubiprostone). AMITIZA is indicated for the treatment of chronic idiopathic constipation in the adult population. Subsequent to this approval, the Patent and Trademark Office received a patent term restoration application for AMITIZA (U.S. Patent No. 5,284,858) from Sucampo AG, and the Patent and Trademark Office requested FDA's assistance in determining this patent's eligibility for patent term restoration. In a letter dated September 5, 2006, FDA advised the Patent and Trademark Office that this human drug product had undergone a regulatory review period and that the approval of AMITIZA represented the first permitted commercial marketing or use of the product. Shortly thereafter, the Patent and Trademark Office requested that FDA determine the product's regulatory review period. FDA has determined that the applicable regulatory review period for AMITIZA is 2,197 days. Of this time, 1,890 days occurred during the testing phase of the regulatory review period, while 307 days occurred during the approval phase. These periods of time were derived from the following dates: 1. *The date an exemption under section 505(i) of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 355(i)) became effective* : January 28, 2000. The applicant claims January 29, 2000, as the date the investigational new drug application

(IND)became effective. However, FDA records indicate that the IND effective date was January 28, 2000, which was 30 days after FDA receipt of the IND. 2. *The date the application was initially submitted with respect to the human drug product under section 505(b) of the act* : March 31, 2005. FDA has verified the applicant's claim that the new drug application

(NDA)for AMITIZA (NDA 21-908) was initially submitted on March 31, 2005. 3. *The date the application was approved* : January 31, 2006. FDA has verified the applicant's claim that NDA 21-908 was approved on January 31, 2006. This determination of the regulatory review period establishes the maximum potential length of a patent extension. However, the U.S. Patent and Trademark Office applies several statutory limitations in its calculations of the actual period for patent extension. In its application for patent extension, this applicant seeks 1,251 days of patent term extension. Anyone with knowledge that any of the dates as published are incorrect may submit to the Division of Dockets Management (see ADDRESSES ) written or electronic comments and ask for a redetermination by April 24, 2007. Furthermore, any interested person may petition FDA for a determination regarding whether the applicant for extension acted with due diligence during the regulatory review period by August 22, 2007. To meet its burden, the petition must contain sufficient facts to merit an FDA investigation. (See H. Rept. 857, part 1, 98th Cong., 2d sess., pp. 41-42, 1984.) Petitions should be in the format specified in 21 CFR 10.30. Comments and petitions should be submitted to the Division of Dockets Management. Three copies of any mailed information are to be submitted, except that individuals may submit one copy. Comments are to be identified with the docket number found in brackets in the heading of this document. Comments and petitions may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday. Dated: February 3, 2007. Jane A. Axelrad, Associate Director for Policy, Center for Drug Evaluation and Research. [FR Doc. E7-3128 Filed 2-22-07; 8:45 am] BILLING CODE 4160-01-S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 2004P-0262] Withdrawal of Approval of 128 Suitability Petitions AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration

(FDA)is withdrawing approval of 128 suitability petitions. This action is being taken in accordance with the Pediatric Research Equity Act of 2003 (PREA). Prior to PREA's enactment, FDA had approved these suitability petitions to permit abbreviated new drug applications (ANDAs) to be submitted for drugs that had a different active ingredient, dosage form, or route of administration than their reference listed drugs (RLDs). However, these approval decisions are being withdrawn because ANDAs were never submitted and PREA requires that all applications submitted on or after April 1, 1999, for a new active ingredient, new indication, new dosage form, new dosing regimen, or new route of administration contain an assessment of the safety and effectiveness of the drug for the claimed indications in relevant pediatric subpopulations unless the requirement is waived or deferred. This action is being taken without prejudice. Any of the suitability petitions may be resubmitted for action by the agency in accordance with current law. DATES: This notice is effective March 26, 2007. FOR FURTHER INFORMATION CONTACT: Cecelia M. Parise, Center for Drug Evaluation and Research (HFD-600), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-5845. SUPPLEMENTARY INFORMATION: PREA (Public Law 108-155) was enacted on December 3, 2003. Among other things, section 2 of PREA requires that all drug applications submitted on or after April 1, 1999, for a new active ingredient, new indication, new dosage form, new dosing regimen, or new route of administration contain an assessment of the safety and effectiveness of the drug for the claimed indications in relevant pediatric subpopulations unless the requirement is waived or deferred. As a result, FDA is withdrawing its approval for 128 suitability petitions for which ANDAS were never submitted. The approval decisions, made prior to the enactment of PREA, would have permitted ANDAs to be submitted for certain drugs that have a different active ingredient, dosage form, or route of administration than their RLDs. No ANDAs were submitted for these drugs pursuant to these suitability petitions prior to April 1, 1999, and any such application submitted on or after April 1, 1999, would be required to contain the safety and effectiveness assessments required by PREA, unless waived or deferred. According to § 314.93(e)(1)(i) (21 CFR 314.93(e)(1)(i)), a suitability petition may not be approved if investigations must be conducted to show the safety and effectiveness of the drug product. In addition, according to § 314.93(f), FDA may withdraw approval of a suitability petition if it receives information demonstrating that the petition no longer satisfies the conditions of § 314.93(e). Under PREA, safety and effectiveness investigations in pediatric subpopulations would be required for the drug products proposed by these suitability petitions, unless the requirement is waived or deferred. Therefore, these suitability petitions no longer satisfy the regulatory requirements for approval. Pursuant to § 314.93(f), FDA is withdrawing approval of the 128 suitability petitions listed in the following table: Petition No. Drug Petitioner 82N-0032/CP6 Chlorzoxazone 500 milligrams

(mg)Mikart, Inc. 84N-0116/CP1 Disopyramide Phosphate 200 mg or 300 mg Biocraft Laboratories, Inc. 84P-0228/CP1 Acetaminophen 500 mg, Codeine Phosphate 30 mg or 60 mg McNeil Pharmaceutical 85P-0067/CP1 Methyltestosterone 25 mg Star Pharmaceuticals 85P-0074/CP1 Hydralazine Hydrochloride 25 mg/5 milliliters

(mL)Roxane Laboratories, Inc. 85P-0081/CP1 Flurazepam Hydrochloride 30 mg/mL Do. 85P-0084/CP1 Vincristine Sulfate 2 mg Bristol Laboratories 85P-0091/CP1 Flurazepam Hydrochloride 15 mg/5 mL Roxane Laboratories, Inc. 85P-0095/CP1 Brompheniramine Maleate 12 mg, Pseudoephedrine Hydrochloride 120 mg UAD Laboratories, Inc. 85P-0129/CP1 Propranolol Hydrochloride 160 mg Verex Laboratories, Inc. 85P-0140/CP1 Dexbrompheniramine Maleate 6 mg, Pseudoephedrine Hydrochloride 120 mg Central Pharmaceuticals, Inc. 85P-0140/CP2 Dexbrompheniramine Maleate 6 mg, Pseudoephedrine Sulfate 120 mg Do. 85P-0147/CP1 Ketoconazole 20 mg/mL Janssen Pharmaceutica 85P-0197/CP1 Propranolol Hydrochloride 80 mg, 120 mg, 160 mg Forest Laboratories 85P-0215/CP1 Disulfiram 500 mg/30 mL Paddock Laboratories 85P-0238/CP2 Dexbrompheniramine Maleate 6 mg, Phenylpropanolamine Hydrochloride 75 mg Bock Pharmacal Co. 85P-0269/CP1 Codeine Phosphate 10 mg/5 mL, Dexbrompheniramine Maleate 1 mg/5 mL, Phenylpropanolamine Hydrochloride 12.5 mg/5 mL Do. 85P-0423/CP1 Benztropine Mesylate 0.5 mg/5 mL RIM Consulting Corp. 85P-0492/CP1 Azatadine Maleate 1 mg, Phenylpropanolamine Hydrochloride 75 mg Smith, Kline & French Laboratories 85P-0499/CP1 Diazepam 2 mg/5 mL Carolina Medical Products Co. 85P-0510/CP1 Spironolactone 25 mg/5 mL Do. 85P-0515/CP1 Lorazepam 0.5 mg, 1 mg, or 2 mg Wyeth Laboratories, Inc. 85P-0516/CP1 Oxazepam 15 mg or 30 mg Do. 85P-0543/CP1 Acetaminophen 300 mg, Codeine Phosphate 30 mg Softan, Inc. 85P-0543/CP2 Acetaminophen 500 mg, Codeine Phosphate 7.5 or 15 mg Do. 85P-0543/CP3 Acetaminophen 500 mg, Oxycodone Hydrochloride 5 mg Do. 85P-0563/CP1 Ibuprofen 300, 400, or 600 mg Do. 85P-0581/CP1 Acetaminophen 500 mg, Propoxyphene Hydrochloride 32 mg Do. 86P-0045/CP1 Propranolol Hydrochloride 10, 20, 40, 60, 80, 90 mg Nutripharm, Inc. 86P-0055/CP1 Spironolactone 25 mg/5 mL Carolina Medical Products Co. 86P-0123/CP1 Cholestyramine 4 grams

(g)Parke-Davis, Division of Warner-Lambert Co. 86P-0200/CP1 Acetaminophen 650 mg, Codeine Phosphate 15 mg Mikart, Inc. 86P-0242/CP1 Floxuridine 500 mg/5 mL Quad Pharmaceuticals, Inc. 86P-0292/CP1 Lorazepam 1 mg/5 mL Roxane Laboratories, Inc. 86P-0359/CP1 Aspirin 356.4 mg, Caffeine 30 mg, Dihydrocodeine Bitartrate 16 mg Central Pharmaceuticals, Inc. 86P-0361/CP1 Acetaminophen 325 mg, Aspirin 325 mg, Codeine Phosphate 30 mg Bock Pharmacal Co. 86P-0427/CP1 Hydrochlorothiazide 50 mg, Triamterene 75 mg Par Pharmaceutical, Inc. 86P-0474/CP1 Cholestyramine 500 mg Bristol-Myers Squibb 87P-0004/CP1 Fluocinonide 0.05% Richard Hamer Assoc. 87P-0037/CP1 Lorazepam 0.5 mg, 1 mg, 2 mg Applied Laboratories, Inc. 87P-0101/CP1 Verapamil Hydrochloride 40 mg/5 mL or 80 mg/5 mL MY-K Laboratories, Inc. 87P-0233/CP1 Verapamil Hydrochloride 120 mg or 240 mg Searle Research & Development 87P-0242/CP1 Ibuprofen 800 mg Sidmak Laboratories, Inc. 87P-0265/CP1 Dexbrompheniramine Maleate 6 mg, Phenypropanolamine Hydrochloride 75 mg Bock Pharmacal Co. (King & Spalding) 87P-0268/CP1 Loperamide Hydrochloride 2 mg Kross, Inc. 87P-0301/CP1 Cholestyramine Resin 4 g Ciba-Geigy Corp. 87P-0314/CP1 Clemastine Fumarate 1.34 mg, Pseudoephedrine Hydrochloride 120 mg Sandoz Consumer Healthcare Group 87P-0323/CP1 Acetaminophen 160 mg/5 mL, Codeine Phosphate 6 mg/5 mL Kleinfeld, Kaplan & Becker 87P-0335/CP1 Triamterene 50 mg, Hydrochlorothiazide 25 mg Par Pharmaceutical, Inc. 87P-0340/CP1 Nifedipine 10 mg or 20 mg Do. 87P-0367/CP1 Phenytoin Sodium 100 mg, 250 mg/vial Lyphomed, Inc. 87P-0399/CP1 Propranolol Hydrochloride 40 mg or 80 mg/5 mL, Hydrochlorothiazide 25 mg/5 mL Burditt, Bowles, Radzius & Rudberry 88P-0011/CP1 Cyclophosphamide 20 mg/mL, 500 mL pharmacy bulk pack

(PBP)Baxter Healthcare Corp. 88P-0036/CP1 Chlorhexidine Gluconate 0.5% Arent, Fox, Kinter, Plotkin & Kahn 88P-0061/CP1 Homatropine Methylbromide 1.5 mg, Hydrocodone Bitartrate 5 mg Kleinfeld, Kaplan & Becker 88P-0149/CP1 Leucovorin Calcium 1 mg/mL Roxane Laboratories, Inc. 88P-0277/CP1 Quinidine Sulfate 300 mg A. H. Robins 88P-0350/CP1 Clemastine Fumarate 1.34 mg, Phenylpropanolamine Hydrochloride 75 mg Scientific Consulting of VA, Inc. 88P-0379/CP1 Cyclophosphamide 20 mg/mL, 250 mL PBP Baxter Healthcare Corp. 88P-0391/CP1 Prednisone 1 mg, 2.5 mg, 5 mg, 10 mg, 20 mg, 25 mg, or 50 mg B.F. Ascher & Co., Inc. 89P-0028/CP1 Hydrocortisone Valerate 0.2% McKenna, Conner & Cuneo 89P-0029/CP1 Hydrocortisone Valerate 0.2% Do. 89P-0071/CP1 Morphine Sulfate 30 mg Ethypharm/Oxford Research Intl. Corp. 89P-0399/CP1 Carbamazepine 200 mg/5 mL Guidelines, Inc. 89P-0435/CP1 Pentamidine Isethionate 100 mg/mL Astra Pharmaceutical Products, Inc. 90P-0049/CP1 Hydrocortisone Acetate 2.5% or 1% Ferndale Laboratories, Inc. 90P-0084/CP1 Chlorzoxazone 250 mg Mikart, Inc. 90P-0154/CP1 Hydrocortisone Acetate 1% Ferndale Laboratories, Inc. 90P-0198/CP1 Clobetasol Propionate 0.05%, RLD = Temovate Kross, Inc. 90P-0436/CP1 Nifedipine 30 mg, 60 mg, 90 mg KV Pharmaceutical Co. 91P-0348/CP1 Albuterol Sulfate 4 mg Richard Hamer Associates, Inc. 92P-0048/CP2 Triazolam 0.125 mg/5 mL Roxane Laboratories, Inc. 92P-0101/CP1 Hydrocortisone Acetate 2.5% Hogan & Hartson 92P-0282/CP1 Acetaminophen 150 mg, Aspirin 180 mg, Hydrocodone Bitartrate 5 mg Mikart, Inc. 92P-0282/CP2 Acetaminophen 150 mg, Aspirin 180 mg, Hydrocodone Bitartrate 7.5 mg Do. 92P-0282/CP3 Acetaminophen 150 mg, Aspirin 180 mg, Hydrocodone Bitartrate 2.5 mg Do. 92P-0282/CP4 Acetaminophen 150 mg, Aspirin 180 mg, Hydrocodone Bitartrate 10 mg Do. 92P-0332/CP1 Propranolol Hydrochloride 40 mg Flemington Pharmaceutical Corp. 92P-0335/CP1 Albuterol Sulfate 2 mg, 4 mg WE Pharmaceuticals, Inc. 92P-0336/CP1 Prednisone 5 mg or 10 mg Do. 92P-0381/CP1 Cytarabine 20 mg/mL, 12.5 mL Bristol-Myers Squibb Co. 92P-0500/CP1 Timethoprim 25 mg/5 mL Ascent Pharmaceuticals, Inc. 93P-0048/CP1 Cimetidine 200, 300, 400 or 800 mg Flemington Pharmaceuticals Corp. 93P-0049/CP1 Propranolol Hydrochloride 10, 20, 60, 80, 90 mg Do. 93P-0314/CP1 Acetaminophen 500 mg, Codeine Phosphate 45 mg Mikart, Inc. 93P-0332/CP1 Loperamide Hydrochloride 1 mg Asta Medica GmbH 93P-0333/CP1 Prednisone 1, 2.5, 20, 50 mg Dura Pharmaceuticals 93P-0346/CP1 Acetaminophen 325 mg, Butalbital 50 mg, Caffeine 40 mg, Hydrocodone Bitartrate 5 mg Mikart, Inc. 93P-0367/CP1 Terfenadine 60 mg, Pseudoephedrine 120 mg Eurand America 93P-0446/CP1 Morphine Sulfate 15 mg, 60 mg, 90 mg, 100 mg Ethypharm 93P-0459/CP1 Methyltestosterone 25 mg ICN Pharmaceuticals, Inc. 94P-0182/CP1 Acetaminophen 120 mg, Codeine Phosphate 12 mg WE Pharmaceuticals, Inc. 94P-0186/CP1 Sulfamethoxazole 200 mg, Trimethoprim 40 mg Dura Pharmaceuticals 94P-0199/CP1 Lorazepam 1 mg/10 mL Roxane Laboratories, Inc. 94P-0210/CP1 Acetaminophen 150 mg, Aspirin 180 mg, Codeine Phosphate 60 mg Mikart, Inc. 94P-0211/CP1 Acetaminophen 150 mg, Aspirin 180 mg, Codeine Phosphate 30 mg Do. 94P-0212/CP1 Acetaminophen 150 mg, Aspirin 180 mg, Codeine Phosphate 15 mg Do. 94P-0263/CP1 Fluorouracil 5% Bradley Pharmaceuticals, Inc. 94P-0432/CP1 Methylprednisolone 16 mg, 24 mg, 32 mg Dura Pharmaceuticals 94P-0433/CP1 Leucovorin Calcium 10 mg/mL 350 mg vial Lederle Laboratories 94P-0433/CP2 Leucovorin Calcium 10 mg/mL 5 mL vial Do. 95P-0008/CP1 Captopril 25 mg/mL Roxane Laboratories, Inc. 95P-0100/CP1 Carbidopa/Levodopa 25/100 mg, 25/250 mg Athena Neurosciences, Inc. 95P-0223/CP1 Hydrocortisone Butyrate 0.1% McKenna & Cuneo, L.L.P. 95P-0268/CP1 Acyclovir Sodium 5 mg/mL Wilmer, Cutler, Pickering 95P-0277/CP1 Cholestyramine 2 g Mayrand Pharmaceuticals, Inc. 95P-0279/CP1 Butalbital 50 mg, Acetaminophen 325 mg, Caffeine 40 mg, Hydrocodone Bitartrate 10 mg Mikart, Inc. 95P-0279/CP2 Butalbital 50 mg, Acetaminophen 325 mg, Caffeine 40 mg, Hydrocodone Bitartrate 7.5 mg Do. 95P-0279/CP3 Butalbital 50 mg, Acetaminophen 500 mg, Caffeine 40 mg, Hydrocodone Bitartrate 10 mg Do. 95P-0279/CP4 Butalbital 50 mg, Acetaminophen 500 mg, Caffeine 40 mg, Hydrocodone Bitartrate 7.5 mg Do. 95P-0326/CP1 Nifedipine 30 mg, 60 mg, 90 mg KV Pharmaceutical Co. 95P-0328/CP1 Metronidazole 0.75% RNB Pharmaceutical Co. 96P-0018/CP1 Potassium Chloride 20 milliequivalents

(meq)KV Pharmaceutical Co. 96P-0021/CP1 Aspirin 650 mg Butalbital 50 mg Savage Laboratories, Division of Altana, Inc. 96P-0054/CP1 Potassium Chloride 10 meq KV Pharmaceutical Co. 96P-0079/CP1 Pentoxyfylline 400 mg Do. 96P-0307/CP1 Acyclovir 5% Pitney, Hardin, Kipp & Szuch 96P-0376/CP1 Hydrocortisone Acetate 90 mg Do. 96P-0510/CP1 Diltiazem Hydrochloride 120 mg, 180 mg, 240 mg, RLD = Cardiazem CD Labopharm, Inc. 97P-0155/CP1 Mefenamic Acid 250 mg Pitney, Hardin, Kipp & Szuch 97P-0192/CP1 Diltiazem Hydrochloride 120 mg, 180 mg, 240 mg, RLD = Dilacor XR Labopharm, Inc. 97P-0195/CP1 Diltiazem Hydrochloride 120 mg, 180 mg, 240 mg, RLD = Tiazac Do. 97P-0387/CP1 Albuterol Sulfate 2 mg and 4 mg Richard Hamer Assoc., Inc. 97P-0404/CP1 Famotidine 10 mg Thomas Blake, R.Ph. 98P-0068/CP1 Clobetasol Propionate 0.05%, RLD = Temovate E Richard Hamer Associates, Inc. 98P-0146/CP1 Ifosfamide 50 mg/mL, 20 mL, and 60 mL Mitchall G. Clark 98P-0199/CP1 Captopril 25 mg/5 mL Miran Consulting, Inc. 98P-0745/CP1 Econazole Nitrate 1% Do. This action is being taken without prejudice. Any of these petitions may be resubmitted for action by the agency in accordance with current law. Dated: February 13, 2007. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. E7-3043 Filed 2-22-07; 8:45 am] BILLING CODE 4160-01-S DEPARTMENT OF HEALTH AND HUMAN SERVICES Substance Abuse and Mental Health Services Administration Agency Information Collection Activities: Proposed Collection; Comment Request In compliance with Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995 concerning opportunity for public comment on proposed collections of information, the Substance Abuse and Mental Health Services Administration will publish periodic summaries of proposed projects. To request more information on the proposed projects or to obtain a copy of the information collection plans, call the SAMHSA Reports Clearance Officer on

(240)276-1243. *Comments are invited on:*

(a)Whether the proposed collections of information are 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 proposed collection of information;

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

(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. Proposed Project: Protection and Advocacy for Individuals with Mental Illness (PAIMI) Annual Program Performance Report (OMB No. 0930-0169)—Revision The Protection and Advocacy for Individuals with Mental Illness (PAIMI) Act, [42 U.S.C. 10801 *et seq.* ] authorized funds to support protection and advocacy services on behalf of individuals with severe mental illness and severe emotional impairment who are at risk for abuse (including incidents of seclusion, restraint, and serious injuries or fatalities related to such incidents, neglect, residing in a public or private care or treatment facility. The PAIMI Program is managed by the Center for Mental Health Services

(CMHS)within the Substance Abuse and Mental Health Services Administration (SAMHSA). Under the PAIMI Act, formula grant awards are made to governor-designated protection and advocacy (P&A) systems in each of the 50 states, the District of Columbia (Mayor), the American Indian Consortium [the Dine (Navajo) and Hopi Peoples in Northern Arizona and New Mexico), and five

(5)territories—American Samoa, Guam, the Northern Mariana Islands, the Commonwealth of Puerto Rico, and the U.S. Virgin Islands. The awards are used to provide legal-based advocacy services which ensure protection against violation of the constitutional and federal rights of individuals with significant (severe) mental illness (adults) and significant (severe) emotional impairment. In 2000, the PAIMI Act amendments, created a 57th P&A system—the American Indian Consortium and authorized P&A systems to serve PAIMI-eligible individuals, as defined under the Act [42 U.S.C. at 10802 (4)], who reside in the community including their own homes. However, P&A services to PAIMI-eligible clients residing in the community is permissible only when the annual PAIMI appropriation met or exceeded $30 million, and that residents in public and private residential care or treatment facilities had service priority over community residents. The Children's Health Act of 2000 (42 U.S.C. 290aa et seq.), also referenced State P&A authority to obtain information on incidents of seclusion, restraint, and related deaths in certain facilities. The PAIMI Act requires each of the 57 P & A systems to file an annual report, no later than January 1st, of its activities and accomplishments and to provide information on such topics as, the numbers of individuals served, types of complaints addressed, and the number of intervention strategies used to resolve the presenting issues. Under the Act, the PAIMI Advisory Council

(PAC)of each P&A system is also required to submit its independent assessment of the effectiveness of the services provided to, and the activities conducted by, the P&A systems on behalf of PAIMI-eligible individuals and their family members, in a separate section of the PPR. The Developmental Disabilities Assistance and Bill of Rights Act of 1975, referred to as the DD Act [42 U.S.C. 6042 *et seq.* ], created the State P&A systems. The Administration on Developmental Disabilities, within the Administration for Children and Families, has administrative oversight of the Protection and Advocacy for Developmental Disabilities

(PADD)Program. Since 1986, the Department has provided formula grant funds to the same governor-designated P&A systems to protect and advocate for individuals with significant mental illness. SAMHSA is currently waiting for the ADD to issue a Notice of Proposed Rulemaking

(NPR)for the DD Act of 2000 amendments. These amendments will also govern activities fulfilled by the State P&A systems under the PAIMI Act. Therefore, to ensure to the greatest extent possible that all facets of the P&A system administered by the Department are subject to the same requirements, SAMHSA will wait until the DD Act NPR is published before revising the PAIMI Rules. [The Final PAIMI Rules were issued in 1997 and were extended in 2000 and 2004. An FRN was published May 2006 to extend the current PAIMI Rules, which will expire in 2007, until 2010]. The Substance Abuse Mental Health Services Administration (SAMHSA) is revising the PAIMI Annual Program Performance Report for the following reasons:

(1)To make it consistent with the requirements of the annual reporting requirements under the PAIMI Act and the PAIMI Rules (42 CFR Part 51), as 2), and the CHA of 2000 Parts H and I;

(2)to conform with the Office of Management and Budget 's

(OMB)findings and recommendations from the FY 2005 PART of the PAIMI Program;

(3)to broaden the category of deaths investigated by the State P&A systems;

(4)to reduce the reporting burdens for the State P&A systems and the PAIMI Advisory Council

(PAC)in certain areas; and,

(5)to enhance the PAC section by providing better information on its role, responsibility, and authority on P&A system PAIMI activities and services. Planned revisions to the PAIMI Annual Program Performance Report

(PPR)and the PAC include the following items:

(1)Changing the fonts to improve readability;

(2)Adding Tables of Contents and Glossaries to the PPR and ACR sections;

(3)Reducing the reporting burden in Section 2. PAIMI Program Priorities and Objectives by requesting only one case example per priority

(goal)rather than per objective;

(4)Revising Sections: 2. PAIMI Program Priorities (Goals) and Objectives: 4. Case Complaints/Problems of Individuals; and, 5. Intervention Strategies on Behalf of Groups of PAIMI-eligible Individuals, for consistency with the findings and recommendations from the Office of Management and Budget (OMB), 2005 PART evaluation/assessment of the PAIMI Program and to clarify and/or enhance the instructional guidance for determining activity/intervention outcomes and estimating the number of individuals or groups impacted by P&A system activities/interventions in sections 4 and 5;

(5)Expanding Section 4. E. 2. by adding an item c. for the number of death investigation activities not related in incidents of seclusion and restraint;

(6)Providing the applicable PAIMI citations to the guidance in Section 8. Other Services & Activities.

(7)Modifying the Advisory Council Report (ACR), Sections B. PAIMI Advisory Council

(PAC)Membership and C. PAC Ethnicity/Racial Diversity for consistency with the format used in the PAIMI Application for FY 2007-2009;

(8)Enhancing Section F. PAC Activities to include the applicable citations that will provide each PAC with better information on its authority, role, and responsibilities as the P&A governing authority.

(9)Revising Section G. PAIMI Assessment of PAIMI Program Operations, by eliminating the previous requirement that the PAC comment on each P&A system annual and objective. The PAC will only submit a summary of its assessment of the P&A system's annual PAIMI Program priorities, objectives, activities and program operations;

(10)Adding an additional item to Section G. to identify the training and technical assistance needs of each PAC; and,

(11)Adding the applicable citations to Section H. Grievance Procedures to include the applicable citations that will provide the PAC with better information on its authority, role, and responsibilities. The revised report formats will be effective for the report due on January 1, 2008. *The annual burden estimate is as follows:* Number of respondents Number of responses per respondent Hours per response Total hour burden Annual Program Performance Report 57 1 26 1,482 Activities & Accomplishments

(20)(1,140) Performance outcomes

(171)Expenses

(57)Budget

(57)Priority statements & objectives

(57)Advisory Council Report 57 1 10 570 Total 114 2,052 Send comments to Summer King, SAMHSA Reports Clearance Officer, Room 7-1045, 1 Choke Cherry Road, Rockville, MD 20857. Written comments should be received within 60 days of this notice. Dated: February 11, 2007. Elaine Parry, Acting Director, Office of Program Services, SAMHSA. [FR Doc. E7-3107 Filed 2-22-07; 8:45 am] BILLING CODE 4162-20-P DEPARTMENT OF HEALTH AND HUMAN SERVICES Substance Abuse and Mental Health Services Administration Notice of a Meeting Pursuant to Public Law 92-463, notice is hereby given of a meeting of the Substance Abuse and Mental Health Services Administration (SAMHSA) National Advisory Council on March 7-8, 2007. The meeting is open to the public and will include a report from the newly appointed SAMHSA Administrator, Dr. Terry L. Cline; a presentation on the National Registry of Evidence-Based Programs and Practices; an update on recent epidemiological data on methamphetamine use; and a presentation on SAMHSA's Workforce Development activities. Attendance by the public will be limited to the space available. Public comments are welcome. Please communicate with the Council's Executive Secretary, Ms. Toian Vaughn (see contact information below), to make arrangements to comment or to request special accommodations for persons with disabilities. Substantive program information, a summary of the meeting, and a roster of Council members may be obtained either by accessing the SAMHSA Committee's Web site at *https://www.nac.samhsa.gov/nac.aspx* as soon as possible after the meeting, or by contacting Ms. Vaughn. The transcript for the meeting will also be available on the SAMHSA Committee's Web site within three weeks after the meeting. *Committee Name:* SAMHSA National Advisory Council. *Date/Time/Type:* Wednesday, March 7, 2007, from 9 a.m. to 5 p.m.: Open. Thursday, March 8, 2007, from 9 a.m. to 12 p.m.: Open. *Place:* 1 Choke Cherry Road, Sugarloaf and Seneca Conference Rooms, Rockville, Maryland 20857. *Contact:* Toian Vaughn, Executive Secretary, SAMHSA National Advisory Council and SAMHSA Committee Management Officer, 1 Choke Cherry Road, Room 8-1089, Rockville, Maryland 20857, Telephone:

(240)276-2307; FAX:

(240)276-2220 and E-mail: *toian.vaughn@samhsa.hhs.gov.* Dated: February 16, 2007. Toian Vaughn, Executive Secretary, SAMHSA National Advisory Council and SAMHSA Committee Management Officer. [FR Doc. E7-3105 Filed 2-22-07; 8:45 am] BILLING CODE 4162-20-P DEPARTMENT OF HOMELAND SECURITY [OMB Control Number: 1651-0101] Preparedness Directorate; National Preparedness Task Force

(NPTF)State Domestic Preparedness Program, State and Local Survey Submission For Review; Reinstatement Previously Discontinued Information Collection Request AGENCY: National Preparedness Task Force, Preparedness Directorate, DHS. ACTION: Notice; 30-day notice of information collections under review: reinstatement previously discontinued information collection request for the State Domestic Preparedness Program, State and Local Survey. SUMMARY: The Department of Homeland Security

(DHS)has submitted the following information collection request

(ICRs)to the Office of Management and Budget

(OMB)for review and clearance in accordance with the Paperwork Reduction Act of 1995. The information collections were previously published in the **Federal Register** on October 12, 2006, volume 71, page 60160 allowing for OMB review and a 60-day public comment period. The purpose of this notice is to allow an additional 30 days for public comment. DATES: Comments are encouraged and will be accepted until March 26, 2007. This process is conduced in accordance with 5 CFR 1320.10. Comments: 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 Nathan Lesser, Desk Officer, Department of Homeland Security/Preparedness, and sent via electronic mail to *oira_submission@omb.eop.gov* or faxed to

(202)395-6974. *The Office of Management and Budget is particularly interested in comments which:*

(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

(202)395-6974. SUPPLEMENTARY INFORMATION: Analysis *Agency:* Department of Homeland Security, Preparedness Directorate, National Preparedness Task Force. *Title:* Fiscal Year 2003 State Domestic Preparedness Program. *OMB No.:* 1651-0101. *Frequency:* On occasion. *Affected Public:* Primary, State, Local and Tribal Government. *Estimated Number of Respondents:* 2,059 respondents. *Estimated Time Per Respondent:* .33 hour per response. *Total Burden Hours:* 679.47. *Total Burden Cost:* (capital/startup): None. *Total Burden Cost:* (operating/maintaining): None. *Description:* This data collection will allow states to:

(1)Report current jurisdictional needs for equipment, training, exercises and technical assistance;

(2)forecast projected needs for this support and

(3)identify the gaps that exist at the jurisdictional level in equipment, training and technical assistance that NPTF and other federal agencies in to the formulation of in the formulation of domestic preparedness policies and with the development of programs to enhance state and local first responder capabilities. Charlie Church, Chief Information Officer, Preparedness Directorate. [FR Doc. E7-3064 Filed 2-22-07; 8:45 am] BILLING CODE 4410-10-P DEPARTMENT OF HOMELAND SECURITY Preparedness Directorate, Office of Infrastructure Preparedness; Submission for New Collection (Chemical Facility Security Training Program) AGENCY: Preparedness Directorate, Office of Infrastructure Preparedness, Department of Homeland Security. ACTION: Notice; 60-day notice request for comments. SUMMARY: The Department of Homeland Security

(DHS)invites the general public and other federal agencies the opportunity to comment on approved information collection request

(ICR)OMB 1670-NEW. As required by the Paperwork Reduction Act of 1995, (Pub. L. 104-13, 44 U.S.C. chapter 35) as amended by the Clinger-Cohen Act (Pub. L. 104-106), DHS is soliciting comments for the approved information collection request. DATES: Written comments should be received on or before April 24, 2007 to be assured consideration. ADDRESSES: OIP CNPPD, Attn: Amy Freireich, 1800 South Bell Street 8th Floor, Arlington, VA 22202 or e-mail *amy.freireich@hq.dhs.gov* or call 703-605-1203. FOR FURTHER INFORMATION CONTACT: 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 Nathan Lesser, Desk Officer, Department of Homeland Security/ Preparedness Directorate, Office of Infrastructure Protection, and sent via electronic mail to *oira_submission@omb.eop.gov* or faxed to

(202)395-6974. SUPPLEMENTARY INFORMATION: Direct all written comments to both the Department of Homeland Security and the Office of Information and Regulatory Affairs at the above addresses. A copy of this ICR, with applicable supporting documentation, may be obtained by calling the Paperwork Reduction Act Contact listed above. *The Office of Management and Budget is particularly interested in comments which:*

(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 submissions of responses. Analysis *Agency:* Department of Homeland Security, Preparedness Directorate, Office of Infrastructure Preparedness. *Title:* DHS Chemical Facility Security Training Program. *OMB Number:* 1670-NEW. *Frequency:* Annually. *Affected Public:* Businesses or other for-profit. *Estimated Number of Respondents:* 400,000. *Estimated Time Per Respondent:* 60 minutes. *Total Burden Hours:* 400,000. *Total Burden Cost:* (capital/startup): $0. *Total Burden Cost:* (operating/maintaining): $16,000 annually. *Description:* The DHS Chemical and Nuclear Preparedness and Protection Division (CNPPD) is providing an Internet on-line voluntary training program to improve security in the chemical industry sector. Information is automatically collected in a computer database as result of individuals engaging in the training. Explicit reporting or recordkeeping is not required. The training is designed for the general chemical facility employee. U.S. chemical industry direct employment is about 882,000 (2004 per American Chemisty Council); approximately half of employees are estimated as potential participants. Estimated duration of training is 30 to 60 minutes in first year, and less if individuals do “refresher” in succeeding years. Minimal participation data are collected automatically as trainee completes the on-line exercises. Upon completion, a Certificate of Completion is generated at the trainee's computer work station, printed and optionally e-mailed to a facility supervisor. DHS will monitor program participation, success in training and basic distribution variables submitted upon registration, but not personal identification, and may analyze and report to government management, Congress and the public periodically. Charlie Church, Director, Information and Technology Division, Chief Information Officer, Preparedness Directorate. [FR Doc. E7-3065 Filed 2-22-07; 8:45 am] BILLING CODE 4410-10-P DEPARTMENT OF HOUSING AND URBAN DEVELOPMENT [Docket No. FR-5117-N-20] Notice of Submission of Proposed Information Collection to OMB; Multifamily Default Status Report AGENCY: Office of the Chief Information Officer, HUD. ACTION: Notice. SUMMARY: The proposed information collection requirement described below has been submitted to the Office of Management and Budget

(OMB)for review, as required by the Paperwork Reduction Act. The Department is soliciting public comments on the subject proposal. Mortgagees use this report to notify HUD that a project owner had defaulted on their mortgage and that an assignment of mortgage will result if HUD and the mortgagor do not develop a plan for reinstating the loan. DATES: *Comments Due Date:* March 26, 2007. ADDRESSES: Interested persons are invited to submit comments regarding this proposal. Comments should refer to the proposal by name and/or OMB approval Number (2502-0041) and should be sent to: HUD Desk Officer, Office of Management and Budget, New Executive Office Building, Washington, DC 20503; fax: 202-395-6974. FOR FURTHER INFORMATION CONTACT: Lillian Deitzer, Departmental Reports Management Officer, QDAM, Department of Housing and Urban Development, 451 Seventh Street, SW., Washington, DC 20410; e-mail *Lillian_L._Deitzer@HUD.gov* or telephone

(202)708-2374. This is not a toll-free number. Copies of available documents submitted to OMB may be obtained from Ms. Deitzer or from HUD's Web site at *http://hlannwp031.hud.gov/po/i/icbts/collectionsearch.cfm.* SUPPLEMENTARY INFORMATION: This notice informs the public that the Department of Housing and Urban Development has submitted to OMB a request for approval of the information collection described below. This notice is soliciting comments from members of the public and affecting agencies concerning the proposed collection of information to:

(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;

(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 collection techniques or other forms of information technology, e.g., permitting electronic submission of responses. This notice also lists the following information: *Title of Proposal:* Multifamily Default Status Report. *OMB Approval Number:* 2502-0041. *Form Numbers:* HUD-92426. *Description of the need for the information and its proposed use:* Mortgagees use this report to notify HUD that a project owner has defaulted on their mortgage and that an assignment of mortgage will result if HUD and the mortgagor do not develop a plan for reinstating the loan. *Frequency of Submission:* On occasion, Other Reporting required when default occurs. Number of respondents Annual responses × Hours per response = Burden hours Reporting Burden 98 116 0.16 1,894. *Total Estimated Burden Hours:* 1,894. *Status:* Extension of a currently approved collection. Authority: Section 3507 of the Paperwork Reduction Act of 1995, 44 U.S.C. 35, as amended. Dated: February 15, 2007. Lillian L. Deitzer, Departmental Paperwork Reduction Act Officer, Office of the Chief Information Officer. [FR Doc. E7-3047 Filed 2-22-07; 8:45 am] BILLING CODE 4210-67-P DEPARTMENT OF HOUSING AND URBAN DEVELOPMENT [Docket No. FR-5125-N-08] 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. EFFECTIVE DATE: February 23, 2007. FOR FURTHER INFORMATION CONTACT: Kathy Ezzell, Department of Housing and Urban Development, Room 7262, 451 Seventh Street, SW., 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 1-800-927-7588. SUPPLEMENTARY INFORMATION: In accordance with the December 12, 1988 court order in *National Coalition for the Homeless* v. *Veterans Administration* , No. 88-2503-OG (D.D.C.), HUD publishes a Notice, on a weekly basis, identifying unutilized, underutilized, excess and surplus Federal buildings and real property that HUD has reviewed for suitability for use to assist the homeless. Today's Notice is for the purpose of announcing that no additional properties have been determined suitable or unsuitable this week. Dated: February 15, 2007. Mark R. Johnston, Deputy Assistant Secretary for Special Needs. [FR Doc. 07-769 Filed 2-22-07; 8:45 am]

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