Notices. Notice of establishment of a Government-wide system of records subject to the Privacy Act of 1974

10,060 words·~46 min read·/register/2006/06/16/06-5471

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

BILLING CODE 1610-01-M FEDERAL COMMUNICATIONS COMMISSION Public Information Collection Approved by Office of Management and Budget June 13, 2006. SUMMARY: The Federal Communications Commission

(FCC)has received Office of Management and Budget

(OMB)approval for the following public information collections pursuant to the Paperwork Reduction Act of 1995, Public Law 104-13. An agency may not conduct or sponsor and a person is not required to respond to a collection of information unless it displays a currently valid control number. FOR FURTHER INFORMATION CONTACT: Ronnie Banks, Federal Communications Commission, 445 12th Street, SW., Washington, DC 20554,

(202)418-1359 or via the Internet at *plaurenz@fcc.gov.* SUPPLEMENTARY INFORMATION: *OMB Control No.:* 3060-0600. *OMB Approval Date:* 6/02/2006. *Expiration Date:* 11/30/2006. *Title:* Application to Partricipate in an FCC Auction. *Form No.:* FCC-175. *Estimated Annual Burden:* 560 responses; 765 total annual burden hours; 1.5 hours average per respondent. *Needs and Uses:* The collection of information needed to implement the Commission's modified designated entity eligibility rules is essential to the Commission's mission. This information collection enables the Commission to ensure that only legitimate small businesses reap the benefits of the Commission's designated entity program. The information collected will be used by the Commission to determine if the applicant is legally, technically, and financially qualified to participate in an FCC auction. In addition, if the applicant applies for status as a particular type of auction participant pursuant to the Commission's rules, the Commission will use the information to determine if the applicant is eligible for the status requested. The Commission's auction rules and requirements are designed to ensure that the competitive bidding process is limited to serious qualified applicants; to deter possible abuse of the bidding and licensing process; and to enhance the use of competitive bidding to assign Commission licenses in furtherance of the public interest. Federal Communications Commission. Marlene H. Dortch, Secretary. [FR Doc. E6-9547 Filed 6-15-06; 8:45 am] BILLING CODE 6712-01-P GENERAL SERVICES ADMINISTRATION Privacy Act of 1974; Proposed Privacy Act System of Records AGENCY: General Services Administration. ACTION: Notice of establishment of a Government-wide system of records subject to the Privacy Act of 1974. SUMMARY: The General Services Administration

(GSA)proposes to establish a Government-wide system of records subject to the Privacy Act of 1974, 5 U.S.C. 552a. The system of records, GSA SmartPay® Purchase Charge Card Program (GSA/GOVT-6), will ensure that the Federal Purchase Charge Card Program, for which GSA has Government-wide responsibility, assembles and maintains information necessary for the efficient and cost effective operation, control, and management of commercial purchasing activities by Federal agencies. The system includes personal information of individuals to enhance the Federal Government's ability to monitor official purchases, payments, and expenses involving charge card transactions. DATES: The system of records will become effective on July 26, 2006 unless comments received on or before that date result in a contrary determination. ADDRESSES: ADDRESS: Comments should be directed to: Director, Support Services Division, Federal Acquisition Service, General Services Administration, 1901 South Bell Street, Arlington VA 22202. FOR FURTHER INFORMATION CONTACT: GSA Privacy Act Officer (CIB), General Services Administration, 1800 F Street NW, Washington, DC 20405; telephone

(202)501-1452. Dated: June 8, 2006. June V. Huber, Director, Office of Information Management. GSA/GOVT-6 **System name:** GSA SmartPay® Purchase Charge Card Program **System location:** System records are located at the Federal agency for which an individual is authorized to perform purchase charge card transactions. Records necessary for a contractor to perform under a Federal agency contract are located at the contractor's facility. Contact the System Manager for additional information. **Categories of individuals covered by the system:** Individuals covered by the system are Federal employees, contractors, and other individuals who apply for and/or use Government-assigned purchase charge cards. **Categories of records in the system:** The system provides control over expenditure of funds through the use of Federal Government purchase cards. System records include: a. Personal information on individuals who apply for and use Federal Government charge cards, including name, Social Security Number, agency of employment, business address (including city, state, country, and zip code), title or position, business telephone, business fax number, and e-mail address. b. Account processing and management information, including purchase authorizations and vouchers, charge card applications, charge card receipts, terms and conditions for card use, charge card transactions, contractor monthly reports showing charges to individual account numbers, account balances, and other data needed to authorize, account for, and pay authorized purchase card expenses. **Authorities for maintenance of the system:** E.O. 9397; E.O. 12931; 40 U.S.C. §§ 501-502. **Purpose:** To establish and maintain a system for operating, controlling, and managing a purchase charge card program involving commercial purchases by authorized Federal Government employees and contractors. **Routine uses of the system records, including categories of users and their purpose for using the system:** System information may be accessed and used by authorized Federal agency employees or contractors to conduct official duties associated with the management and operation of the purchase charge card program. Information from this system also may be disclosed as a routine use: a. To a Federal, State, local, or foreign agency responsible for investigating, prosecuting, enforcing, or carrying out a statute, rule, regulation, or order, where an agency becomes aware of a violation or potential violation of civil or criminal law or regulation. b. To an appeal, grievance, or formal complaints examiner; equal employment opportunity investigator; arbitrator; or other official engaged in investigating, or settling a grievance, complaint, or appeal filed by an individual who is the subject of the record. c. To officials of labor organizations recognized under Pub. L. 95-454, when necessary to their duties of exclusive representation on personnel policies, practices, and matters affecting working conditions. d. To another Federal agency in connection with the hiring or retention of an employee; the issuance of a security clearance; the reporting of an investigation; clarifying a job; the letting of a contract; or the issuance of a grant, license, or other benefit to the extent that the information is relevant and necessary to a decision. e. To the Office of Personnel Management (OPM), the Office of Management and Budget (OMB), the Government Accountability Office

(GAO)or other Federal agency when the information is required for program evaluation purposes. f. To a Member of Congress or staff on behalf of and at the request of the individual who is the subject of the record. g. To the National Archives and Records Administration

(NARA)for records management purposes. h. To an expert, consultant, or contractor in the performance of a Federal duty to which the information is relevant, including issuance of charge cards. i. To GSA in the form of listings, reports, and records of all transportation related transactions, including refunds and adjustments, by the contractor to enable audits of transportation related charges to the Government. j. To GSA contract agents assigned to participating agencies for billing of purchase expenses. k. To agency finance offices for debt collection purposes. **Policies and practices for storing, retrieving, accessing, retaining, and disposing of system records:** **Storage:** Information may be collected on paper or electronically and may be stored on paper or on electronic media, as appropriate. **Retrievability:** Records may be retrieved by name, Social Security Number, credit card number, and/or other personal identifier or appropriate type of designation. **Safeguards:** System records are safeguarded in accordance with the requirements of the Privacy Act, the Computer Security Act, and OMB Circular A-130. Technical, administrative, and personnel security measures are implemented to ensure confidentiality and integrity of the system data stored, processed, and transmitted. Paper records are stored in secure cabinets or rooms. Electronic records are protected by passwords and other appropriate security measures. **Retention and disposal:** Disposition of records is according to the National Archives and Records Administration

(NARA)guidelines, as set forth in the handbook, GSA Records Maintenance and Disposition System (OAD P 1820.2A and CIO P 1820.1), authorized GSA records schedules, and by individual agencies. **System manager and address:** Director, Office of Commercial Acquisition (FC), General Services Administration, 1901 South Bell Street, Arlington VA 22202. Also, officials responsible for individual agency purchase card programs using the SmartPay®system. **Notification procedure:** Individuals may obtain information about their records from the purchase charge card program manager of the agency for which they transact purchases. **Record access procedures:** Requests from individuals for access to their records should be addressed to their agency's purchase charge card program manager or to the finance office of the agency for which the individual transacts purchases. **Contesting record procedures:** Individuals may access their records, contest the contents, and appeal determinations according to their agency's rules. **Record source categories:** Information is obtained from individuals submitting charge card applications, monthly contractor reports, purchase records, managers, other agencies, non-Federal sources such as private firms, and other agency systems containing information pertaining to the purchase charge card program. [FR Doc. E6-9407 Filed 6-15-06; 8:45 am] BILLING CODE 6820-34-S DEPARTMENT OF HEALTH AND HUMAN SERVICES Administration on Aging Agency Information Collection Activities; Submission for OMB Review; Comment Request; Extension With Change of the Expiration Date of the Title VI Program Performance Report AGENCY: Administration on Aging, HHS. ACTION: Notice. SUMMARY: The Administration on Aging

(AoA)is announcing that the proposed collection of information listed below has been submitted to the Office of Management and Budget

(OMB)for review and clearance under the Paperwork Reduction Act of 1995. DATES: Submit written comments on the collection of information by July 17, 2006. ADDRESSES: Submit written comments on the collection of information to the Office of Information and Regulatory Affairs, OMB, New Executive Office Bldg., 725 17th St., NW., rm. 10235, Washington, DC 20503, Attn: Brenda Aguilar, Desk Officer for AoA. FOR FURTHER INFORMATION CONTACT: Yvonne Jackson; Director; Office for American Indian, Alaskan Native and Native Hawaiian Programs; Administration on Aging, Washington, DC 20201;

(202)357-3501; *Yvonne.Jackson@aoa.gov* . SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, AoA has submitted the following proposed collection of information to OMB for review and clearance. The Program Performance Report provides a data base for AoA to

(1)Monitor program achievement of performance objectives;

(2)establish program policy and direction; and

(3)prepare responses to Congress, the OMB, the General Accounting Office, other Federal departments, and public and private agencies as required by the OAA Title II sections 202(a)19 and 208; and prepare data for the Federal Interagency Task Force on Older Indians established pursuant to section 134(d) of the 1987 Amendments to the OAA. AoA estimates the burden of this collection of information as follows: The estimate of total respondent burden is 243 hours per year to prepare reports. In the **Federal Register** of February 23, 2006 (Vol. 71, No. 36, Page 9345), the agency requested comments on the proposed collection of information. No comments were received. Dated: June 13, 2006. Josefina G. Carbonell, Assistant Secretary for Aging. [FR Doc. E6-9487 Filed 6-15-06; 8:45 am] BILLING CODE 4154-01-P DEPARTMENT OF HEALTH AND HUMAN SERVICES Administration on Aging 2005 White House Conference on Aging AGENCY: Administration on Aging, HHS. ACTION: Notice of conference call. SUMMARY: Pursuant to Section 10(a) of the Federal Advisory Committee Act as amended (5 U.S.C. Appendix 2), notice is hereby given that the Policy Committee of the 2005 White House Conference on Aging will discuss items related to the final report of the Conference during a conference call. The conference call will be open to the public to listen, with call-ins limited to the number of telephone lines available. Individuals who plan to call in and need special assistance, such as TTY, should inform the contact person listed below in advance of the conference call. This notice is being published less than 15 days prior to the conference call due to scheduling problems. DATES: The conference call will be held on Wednesday, June 14, 2006, at 11 a.m., Eastern Standard Time. ADDRESSES: The conference call may be accessed by dialing, U.S. toll-free, 1-800-369-3181, passcode: 2108199, call leader: Nora Andrews, on the date and time indicated above. FOR FURTHER INFORMATION CONTACT: Nora Andrews,

(202)357-3463, or e-mail at *Nora.Andrews@hhs.gov* . Registration is not required. Call in is on a first come, first-served basis. Dated: June 13, 2006. Edwin L. Walker, Deputy Assistant Secretary for Policy and Programs. [FR Doc. E6-9463 Filed 6-15-06; 8:45 am] BILLING CODE 4154-01-P DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention Disease, Disability, and Injury Prevention and Control Special Emphasis Panel: HIV II—Identifying Ground-Breaking Behavioral Interventions To Prevent HIV Transmission, Program Announcement

(PA)PS06-005; Reducing Sexual Risk HIV Acquisition and Transmission, PA PS06-007 and HIV Prevention Intervention Research With HIV Positive Incarcerated Populations, PA PS06-011 *Correction:* This notice was published in the **Federal Register** on May 26, 2006, Volume 71, Number 102, page 30420. The date of the Special Emphasis Panel meeting has been changed to July 14, 2006. *Titles:* HIV II—Identifying Ground-Breaking Behavioral Interventions to Prevent HIV Transmission, Program Announcement

(PA)PS06-005; Reducing Sexual Risk HIV Acquisition and Transmission, PA PS06-007 and HIV Prevention Intervention Research With HIV Positive Incarcerated Populations, PA PS06-011. FOR FURTHER INFORMATION CONTACT: Chris Langub, Ph.D., Scientific Review Administrator, National Institute for Occupational Safety and Health, CDC, 1600 Clifton Road NE., Mailstop D72, Atlanta, GA 30333, Telephone 404-639-4640. The Director, Management Analysis and Services Office, has been delegated the authority to sign Federal Register notices pertaining to announcements of meetings and other committee management activities, for both CDC and the Agency for Toxic Substances and Disease Registry. Dated: June 9, 2006. Alvin Hall, Director, Management Analysis and Services Office,Centers for Disease Control and Prevention. [FR Doc. E6-9444 Filed 6-15-06; 8:45 am] BILLING CODE 4163-18-P DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention Disease, Disability, and Injury Prevention and Control Special Emphasis Panel: Portfolio Review of Early Hearing Detection and Intervention Program 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 following meeting: *Name:* Disease, Disability, and Injury Prevention and Control Special Emphasis Panel: Portfolio Review of Early Hearing Detection and Intervention Program. *Time and Date:* 8:30 a.m.-5 p.m., July 17, 2006 (Closed). *Place:* National Center on Birth Defects and Developmental Disabilities, CDC, 12 Executive Park Drive, Atlanta, GA 30329, Telephone Number 404-498-3800. *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 a discussion of the “Early Hearing Detection and Intervention Program.” *For Further Information Contact:* Esther Sumartojo, Associate Director for Science and Public Health, National Center on Birth Defects and Developmental Disabilities, CDC, 1600 Clifton Road, NE., Mailstop E-87, Atlanta, GA 30333, Telephone Number 404-498-3800. The Director, Management Analysis and Services Office, has been delegated the authority to sign Federal Register notices pertaining to announcements of meetings and other committee management activities, for both CDC and the Agency for Toxic Substances and Disease Registry. Dated: June 9, 2006. Alvin Hall, Director, Management Analysis and Services Office, Centers for Disease Control and Prevention. [FR Doc. E6-9447 Filed 6-15-06; 8:45 am] BILLING CODE 4163-18-P DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Medicare & Medicaid Services [Document Identifier: CMS-10078, CMS-10197, CMS-10185 and CMS-685] Agency Information Collection Activities: Proposed Collection; 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)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

(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:* Matching Grants to States for the Operation of High Risk Pools and Supporting Regulations at 42 CFR 148.316, 148.318, and 148.320; *Use:* CMS is requiring this information as a condition of eligibility for grants that were authorized in the Trade Act of 2002 (Pub. L. 107-210). The information is necessary to determine if a State applicant meets the necessary eligibility criteria for a grant as required by the law. The respondents will be States that have a high risk pool as defined in Section 2744(c)(2) of the Public Health Service Act. The grants will provide matching funds to States that incur losses in the operation of high risk pools. High risk pools are set up by States to provide health insurance to individuals that cannot obtain health insurance in the private market because of a history of illness. *Form Number:* CMS-10078 (OMB#: 0938-0887); *Frequency:* Reporting—On occasion; *Affected Public:* State, local, or tribal government; *Number of Respondents:* 33; *Total Annual Responses:* 33; *Total Annual Hours:* 1,320. 2. *Type of Information Collection Request:* New collection; *Title of Information Collection:* Evaluation of the Medicare National Competitive Bidding Program for DME; *Use:* Section 302(b) of The Medicare Prescription Drug, Improvement, and Modernization Act of 2003

(MMA)requires the Centers for Medicare and Medicaid Services

(CMS)to begin a program of competitive bidding for durable medical equipment (DME), supplies, certain orthotics, and enteral nutrients and related equipment and supplies. MMA Section 303(d) requires a Report to Congress on the program, covering program savings, reductions in cost sharing, impacts on access to and quality of affected goods and services, and beneficiary satisfaction. This project's purpose is to provide information for this Report to Congress. *Form Number:* CMS-10197 (OMB#: 0938--New); *Frequency:* Reporting—Other: Baseline and Follow-up; *Affected Public:* Individuals or Households, Business or other for-profit, Federal Government and Not-for-profit institutions; *Number of Respondents:* 12,671; *Total Annual Responses:* 12,671; *Total Annual Hours:* 6,557. 3. *Type of Information Collection Request:* Extension of a currently approved collection; *Title of Information Collection:* Medicare Part D Reporting Requirements and Supporting Regulations under 42 CFR 423.505; *Use:* Data collected via Medicare Part D Reporting Requirements will be an integral resource for oversight, monitoring, compliance and auditing activities necessary to ensure quality provision of the Medicare Prescription Drug Benefit to beneficiaries. Data will be validated, analyzed, and utilized for trend reporting by CMS. If outliers or other data anomalies are detected, CMS will work in collaboration with other CMS divisions for follow-up and resolution. *Form Number:* CMS-10185 (OMB#: 0938-0992); *Frequency:* Reporting: Quarterly and Semi-annually; *Affected Public:* Business or other for-profit; *Number of Respondents:* 3,203; *Total Annual Responses:* 12,812; *Total Annual Hours:* 102,496. 4. *Type of Information Collection Request:* Extension of a currently approved collection; *Title of Information Collection:* End Stage Renal Disease

(ESRD)Network Semi-Annual Cost Report Forms and Supporting Regulations in 42 CFR 405.2110 and 42 CFR 405.2112; *Use:* Section 1881(c) of the Social Security Act establishes End Stage Renal Disease

(ESRD)Network contracts. The regulations designated at 42 CFR 405.2110 and 405.2112 designated 18 ESRD Networks which are funded by renewable contracts. These contracts are on 3-year cycles. To better administer the program, CMS is requiring contractors to submit semi-annual cost reports. The purpose of the cost reports is to enable the ESRD Networks to report costs in a standardized manner. This will allow CMS to review, compare and project ESRD Network costs during the life of the contract. *Form Number:* CMS-685 (OMB#: 0938-0657); *Frequency:* Reporting—Semi-annually; *Affected Public:* Not-for-profit institutions; *Number of Respondents:* 18; *Total Annual Responses:* 36; *Total Annual Hours:* 108. 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 August 15, 2006. CMS, Office of Strategic Operations and Regulatory Affairs, Division of Regulations Development—A, Attention: Melissa Musotto, Room C4-26-05, 7500 Security Boulevard, Baltimore, Maryland 21244-1850. Dated: June 9, 2006. Michelle Shortt, Director, Regulations Development Group, Office of Strategic Operations and Regulatory Affairs. [FR Doc. E6-9478 Filed 6-15-06; 8:45 am] BILLING CODE 4120-01-P DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Medicare & Medicaid Services [Document Identifier: CMS-R-194 and CMS-R-52] 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

(FI)using a combination of Medicare Part A and Supplemental Security Income data provided by CMS, and Medicaid data calculated from the hospital's cost report. The data provided through these calculations are then compared to the qualifying criteria located in 42 CFR 412.106 to determine the final adjustment. If these calculations, based on the Federal fiscal year, do not allow the hospital to qualify for a disproportionate share adjustment, the hospital may request that the calculations be performed using its cost reporting period; *Form Number:* CMS-R-194 (OMB#: 0938-0691); *Frequency:* Recordkeeping and Reporting—On occasion; *Affected Public:* Business or other for-profit and Not-for-profit institutions; *Number of Respondents:* 100; *Total Annual Responses:* 100; *Total Annual Hours:* 100. 2. *Type of Information Collection Request:* Extension of a currently approved collection; *Title of Information Collection:* Conditions for Coverage of Suppliers of End Stage Renal Disease

(ESRD)Services and Supporting Regulations Contained in 42 CFR 405.2100-405.2171; *Use:* The requirements associated with the Medicare and Medicaid Conditions for Coverage for Suppliers of ESRD Services fall into two categories: record keeping requirements and reporting requirements. With regard to the recordkeeping requirements, CMS uses these conditions for coverage to certify health care facilities that want to participate in the Medicare or Medicaid programs. These record keeping requirements are no different than other conditions for coverage in that they reflect comparable standards developed by industry organizations such as the Renal Physicians Association, American Society of Transplant Surgeons, and the National Association of Patients on Hemodialysis and Transplantation. With respect to reporting requirements, the information is needed to assess and ensure proper distribution and effective utilization of ESRD treatment resources while maintaining or improving quality of care. It is CMS's responsibility to closely monitor ESRD service utilization to prevent over-expansion of facilities and resultant under-utilization; *Form Number:* CMS-R-52 (OMB#: 0938-0386); *Frequency:* Recordkeeping and Reporting—Annually; *Affected Public:* Business or other for-profit and Federal government; *Number of Respondents:* 4,757; *Total Annual Responses:* 4,757; *Total Annual Hours:* 160,702. 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: June 9, 2006. Michelle Shortt, Director, Regulations Development Group, Office of Strategic Operations and Regulatory Affairs. [FR Doc. E6-9479 Filed 6-15-06; 8:45 am] BILLING CODE 4120-01-P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 2006N-0222] Merck & Co., Inc., et al.; Withdrawal of Approval of 65 New Drug Applications and 52 Abbreviated New Drug Applications AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration

(FDA)is withdrawing approval of 65 new drug applications

(NDAs)and 52 abbreviated new drug applications (ANDAs) from multiple applicants. The holders of the applications notified the agency in writing that the drug products were no longer marketed and requested that the approval of the applications be withdrawn. DATES: Effective June 16, 2006. FOR FURTHER INFORMATION CONTACT: Florine P. Purdie, Center for Drug Evaluation and Research (HFD-7), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-594-2041. SUPPLEMENTARY INFORMATION: The holders of the applications listed in the table in this document have informed FDA that these drug products are no longer marketed and have requested that FDA withdraw approval of the applications. The applicants have also, by their requests, waived their opportunity for a hearing. Application No. Drug Applicant NDA 1-645 Vitamin B6 (pyridoxine hydrochloride (HCl)) Merck & Co., Inc., 770 Sumneytown Pike, P.O. Box 4, BLA-20, West Point, PA 19486-0004 NDA 5-521 Heparin Sodium Injection USP Eli Lilly and Co., Lilly Corporate Center, Indianapolis, IN 46285 NDA 5-657 Tubocurarine Chloride Injection USP Bristol-Myers Squibb Co., P.O. Box 4500, Princeton, NJ 08543-4500 NDA 5-794 Sultrin Triple Sulfa Cream and Triple Sulfa Tablets Ortho-McNeil Pharmaceutical, Inc., 1000 U.S. Highway 202, P.O. Box 300, Raritan, NJ 08869-0602 NDA 6-012 Folvron (folic acid and iron) Lederle Laboratories, 401 North Middleton Rd., Pearl River, NY 10965 NDA 7-149 Rubramin (cyanocobalamin) Tablets and Capsules Bristol-Myers Squibb Co. NDA 7-504 Acthar (corticotropin for injection) Aventis Pharmaceuticals, Inc., 200 Crossing Blvd., BX 2-309E, Bridgewater, NJ 08807 NDA 7-794 Neothylline (dyphylline) Teva Pharmaceuticals USA, 1090 Horsham Rd., P.O. Box 1090, North Wales, PA 19454 NDA 9-176 Cortril (hydrocortisone) Topical Ointment Pfizer Global Pharmaceuticals, 235 East 42nd St., New York, NY 10017 NDA 10-028 Equanil (meprobamate) Tablets Wyeth Pharmaceuticals, P.O. Box 8299, Philadelphia, PA 19101-8299 NDA 10-093 Biphetamine (dextroamphetamine and amphetamine) Capsules Celltech Pharmaceuticals, Inc., 755 Jefferson Rd., P.O. Box 31710, Rochester, NY 14603 NDA 10-513 Ketonil (amino acids and electrolytes) Merck & Co., Inc. NDA 10-787 Iron Dextran Injection Aventis Pharmaceuticals, Inc. NDA 10-799 Dimetane (brompheniramine maleate) Tablets and Extendtabs Wyeth Consumer Healthcare, 5 Giralda Farms, Madison, NJ 07940 NDA 11-340 Cerumenex (triethanolamine polypeptide oleate-condensate), 10% The Purdue Frederick Co., 1 Stamford Forum, Stamford, CT 06901-3431 NDA 11-960 Aristocort (triamcinolone diacetate) Syrup Astellas Pharma US, Inc., 3 Parkway North, Deerfield, IL 60015-2548 NDA 11-984 Decadron Phosphate (dexamethasone sodium phosphate) Sterile Ophthalmic Solution Merck & Co., Inc. NDA 12-122 Glucagon (glucagon HCl) for Injection Eli Lilly & Co. NDA 12-281 Robaxisal (methocarbamol USP and aspirin USP) Tablets A.H. Robins Co., c/o Wyeth Pharmaceuticals, P.O. Box 8299, Philadelphia, PA 19101-8299 NDA 12-649 Periactin (cyproheptadine HCl) Merck & Co., Inc. NDA 12-703 Elavil (amitriptyline HCl) Tablets AstraZeneca Pharmaceuticals, 1800 Concord Pike, P.O. Box 8355, Wilmington, DE 19803-8355 NDA 12-704 Elavil (amitriptyline HCl) Injection Do. NDA 13-220 Periactin (cyproheptadine HCl) Syrup, 2 milligrams (mg)/5 milliliters

(mL)Merck & Co., Inc. NDA 13-400 Aldomet (methyldopa) Tablets Do. NDA 13-401 Aldomet (methyldopate HCl) Injection, 50 mg/mL Do. NDA 13-413 Dexacort Phosphate (dexamethasone sodium phosphate) in Respihaler Celltech Pharmaceuticals, Inc. NDA 16-016 Aldoclor-150 and -250 (methyldopa and chlorothiazide) Tablets, 250 mg/150 mg and 250 mg/250 mg Merck & Co., Inc. NDA 16-030 Bayer 8 Hour Aspirin and Measurin Aspirin (aspirin extended-release tablets), 650 mg Bayer Healthcare, LLC, 36 Columbia Rd., P.O. Box 1910, Morristown, NJ 07962-1910 NDA 16-099 Atromid-S (clofibrate) Capsules Wyeth Pharmaceuticals NDA 16-745 Jergens Antibacterial Deodorant (triclocarban, 1%) Soap Kao Brands Co., 2535 Springs Grove Ave., Cincinnati, OH 45214-1773 NDA 16-888 Selsun Blue (selenium sulfide) Cream/Shampoo, 1% Abbott Laboratories, 625 Cleveland Ave., Columbus, OH 43215-1724 NDA 17-569 Renoquid (sulfacytine) Tablets Glenwood LLC, 111 Cedar Lane, Englewood, NJ 07631 NDA 17-573 Vanceril (beclomethasone dipropionate) Inhalation Aerosol Schering Corp., 2000 Galloping Hill Rd., Kenilworth, NJ 07033 NDA 17-659 Alupent (metaproterenol sulfate) Inhalation Solution, 5% Boehringer Ingelheim Pharmaceuticals, Inc., 900 Ridgebury Rd., P.O. Box 368, Ridgefield, CT 06877-0368 NDA 17-781 Diprosone (betamethasone dipropionate) Lotion Schering Corp. NDA 17-820 Dobutrex (dobutamine HCl) Sterile Injection Eli Lilly & Co. ANDA 18-023 Lactated Ringer's Injection USP B. Braun Medical, Inc., 2525 McGaw Ave., P.O. Box 19791, Irvine, CA 92623-9791 ANDA 18-026 5% Dextrose and 0.9% Sodium Chloride

(NaCl)Injection Do. ANDA 18-046 10% Dextrose Injection USP Do. ANDA 18-047 10% Dextrose and 0.9% NaCl Injection USP Do. ANDA 18-184 0.45% NaCl Injection USP Do. ANDA 18-186 1/6 Molar Sodium Lactate Injection USP in Plastic Container Do. ANDA 18-197 Ibuprofen Tablets BASF Corp., 8800 Line Ave., Shreveport, LA 71106 ANDA 18-252 Isolyte S (multi-electrolyte injection) Injection B. Braun Medical, Inc. ANDA 18-256 5% Dextrose in Ringer's Injection Do. NDA 18-257 Tonocard (tocainide HCl) Tablets, 400 mg and 600 mg AstraZeneca Pharmaceuticals ANDA 18-274 Isolyte S (multi-electrolyte injection) with 5% Dextrose in Plastic Container B. Braun Medical, Inc. NDA 18-389 Aldomet (methyldopa) Oral Suspension, 250 mg/5 mL Merck & Co., Inc. NDA 18-682 TZ-3 (1% tioconazole) Dermal Cream Pfizer, Inc., 235 East 42nd St., New York, NY 10017 NDA 18-686 Normodyne (labetalol HCl USP) Injection, 5 mg/mL Schering Corp. NDA 18-687 Normodyne (labetalol HCl USP) Tablets Do. ANDA 18-721 Ringer's Injection USP B. Braun Medical, Inc. NDA 18-754 Orudis (ketoprofen) Capsules, 25 mg, 50 mg, and 75 mg Wyeth Pharmaceuticals NDA 18-792 Neopham (amino acids) Injection Hospira, Inc., 275 North Field Dr., Dept. 389, Bldg. 2, Lake Forest, IL 60045 NDA 18-901 Aminess (essential amino acids injection with histidine) Do. NDA 18-911 Heparin Sodium in 5% Dextrose Injection and Heparin Sodium in NaCl Injection Do. NDA 19-083 Theophylline and 5% Dextrose Injection B. Braun Medical, Inc. NDA 19-107 Protropin (somatrem) for Injection Genentech, Inc., 1 DNA Way MS#242, South San Francisco, CA 94080-4990 ANDA 19-138 Alphatrex (betamethasone dipropionate cream USP) 0.05% Savage Laboratories, 60 Baylis Rd., Melville, NY 11747 ANDA 19-143 Alphatrex (betamethasone dipropionate ointment USP) 0.05% Do. NDA 19-383 Proventil (albuterol sulfate extended-release tablets USP) Repetabs Schering Corp. NDA 19-401 Pseudo-12 Suspension (pseudoephedrine polistirex extended-release suspension) Celltech Pharmaceuticals, Inc. NDA 19-523 Cysteine HCl Injection USP, 7.25% Hospira, Inc. NDA 19-589 Vancenase AQ (beclomethasone dipropionate) Nasal Spray Schering Corp. NDA 19-621 Ventolin (albuterol sulfate) Syrup GlaxoSmithKline Pharmaceuticals, 5 More Dr., P.O. Box 13358, Research Triangle Park, NC 27709 NDA 20-035 Ergamisol (levamisole HCl) Tablets Johnson & Johnson Pharmaceutical Research and Development, LLC, c/o Janssen Pharmaceutical Products, LP, 1125 Trenton-Harbourton Rd., K1-02B, Titusville, NJ 08560-0200 NDA 20-176 VitaPed (multivitamins) Hospira, Inc. NDA 20-338 Differin (adapalene) Solution, 0.1% Galderma Laboratories, LP, 14501 North Freeway, Fort Worth, TX 76177 NDA 20-759 Trovan (trovafloxacin mesylate) Tablets, 100 mg and 200 mg Pfizer, Inc. NDA 20-760 Trovan (alatrofloxacin mesylate) Injection Do. NDA 20-847 Esclim (estradiol extended-release film) Transdermal System Women First Healthcare, Inc., 380 Lexington Ave., New York, NY 10168 NDA 20-962 Emla (2.5% lidocaine and 2.5% prilocaine) Anesthetic Disc AstraZeneca Pharmaceuticals ANDA 40-023 Adrucil (fluorouracil injection USP), 50 mg/mL Sicor Pharmaceuticals, Inc., 19 Hughes, Irvine, CA 92618 ANDA 40-147 Leucovorin Calcium Injection USP, 10 mg (base)/mL Hospira, Inc. NDA 50-039 Garamycin (gentamicin sulfate) Ophthalmic Solution Schering Corp. NDA 50-091 Chloroptic (chloramphenicol ophthalmic solution USP), 0.5% Allergan, Inc., 2525 Dupont Dr., P.O. Box 19534, Irvine, CA 92623-9534 NDA 50-322 Neodecadron (neomycin sulfate and dexamethasone sodium phosphate) Sterile Ophthalmic Solution Merck & Co., Inc. NDA 50-368 Ilotycin (erythromycin) Ophthalmic Ointment Eli Lilly & Co. NDA 50-571 CefMax (cefmenoxime HCl) Injection TAP Pharmaceutical Products, Inc., 675 North Field Dr., Lake Forest, IL 60045 NDA 50-648 Clindamycin Phosphate Injection in 5% Dextrose Baxter Healthcare Corp., Route 120 & Wilson Rd., Round Lake, IL 60073 ANDA 60-429 Sumycin Capsules (tetracycline HCl capsules USP) Apothecon, c/o Bristol-Myers Squibb Co., P.O. Box 4500, Princeton, NJ 08543-4500 ANDA 62-480 Gentacidin Solution (gentamicin sulfate ophthalmic solution USP) Novartis Pharmaceuticals Corp., 1 Health Plaza, Bldg. 118, East Hanover, NJ 07936-1080 ANDA 62-597 Mytrex (nystatin and triamcinolone acetonide cream USP) 100,000 units/gram

(g)and 1 mg/g Savage Laboratories ANDA 62-601 Mytrex (nystatin and triamcinolone acetonide ointment USP) 100,000 units/g and 1 mg/g Do. ANDA 62-750 Pipracil (piperacillin for injection), 2 g, 3 g, and 4 g Wyeth Pharmaceuticals, Inc. ANDA 63-186 Cephalexin Capsules USP, 250 mg and 500 mg Apothecon, c/o Bristol-Myers Squibb Co. ANDA 64-084 Sterile Bleomycin Sulfate for Injection USP, 15 and 30 units/vial Sicor Pharmaceuticals, Inc. ANDA 70-083 Ibuprofen Tablets USP, 400 mg BASF Corp. ANDA 70-099 Ibuprofen Tablets USP, 600 mg Do. ANDA 70-273 Alphatrex (betamethasone dipropionate lotion USP), 0.05% Savage Laboratories ANDA 70-745 Ibuprofen Tablets USP, 800 mg BASF Corp. ANDA 72-621 Acetylcysteine Solution USP, 10% Roxane Laboratories, Inc., P.O. Box 16532, Columbus, OH 43216 ANDA 72-622 Acetylcysteine Solution USP, 20% Do. ANDA 72-995 Metoclopramide HCl Oral Solution, 10 mg/mL Do. ANDA 73-562 Diflunisal Tablets USP, 250 mg Do. ANDA 73-563 Diflunisal Tablets USP, 500 mg Do. ANDA 74-166 Toposar (etoposide injection USP), 20 mg/mL Sicor Pharmaceuticals, Inc. ANDA 74-541 Cimetidine HCl Oral Solution, 30 mg/5 mL Roxane Laboratories, Inc. ANDA 74-663 Acyclovir Sodium for Injection USP, 500 mg base/vial and 1 g base/vial Hospira, Inc. ANDA 75-179 Nabumetone Tablets Copley Pharmaceutical, Inc., 1090 Horsham Rd., P.O. Box 1090, North Wales, PA 19454 ANDA 75-875 Carbamazepine Oral Suspension USP, 100 mg/5 mL Taro Pharmaceutical Industries, Ltd., c/o Taro Pharmaceuticals, U.S. Agent, 5 Skyline Dr., Hawthorne, NY 10532 ANDA 80-643 Diphenhydramine HCl Elixir USP, 25 mg/10 mL Roxane Laboratories, Inc. ANDA 81-225 Adrucil (etopside injection USP), 50 mg/mL Sicor Pharmaceuticals, Inc. ANDA 83-261 Pentobarbital Sodium Injection USP Wyeth Pharmaceuticals ANDA 83-383 Diucardin (hydroflumethiazide tablets USP) Tablets, 50 mg Do. ANDA 84-015 Bleph-10 (sulfacetamide sodium ophthalmic ointment USP) Ophthalmic Ointment, 10% Allergan, Inc. ANDA 84-514 Dilor (dyphylline tablets USP), 200 mg Savage Laboratories ANDA 84-751 Dilor-400 (dyphylline tablets USP), 400 mg Do. ANDA 85-035 Diphenoxylate HCl and Atropine Sulfate Tablets USP, 2.5 mg and 0.025 mg R & S Pharma, LLC, 8407 Austin Tracy Rd., Fountain Run, KY 42133 ANDA 85-961 Methocarbamol Tablets USP, 500 mg Clonmel Healthcare Ltd., c/o STADA Pharmaceuticals, Inc., U.S. Agent, 5 Cedar Brook Dr., Cranbury, NJ 08512 ANDA 85-963 Methocarbomal Tablets USP, 750 mg Do. ANDA 86-899 Isoetharine HCl Inhalation Solution USP, 1% Roxane Laboratories, Inc. ANDA 87-450 Chlorthalidone Tablets USP, 50 mg Clonmel Healthcare Ltd. ANDA 87-451 Chlorthalidone Tablets USP, 25 mg Do. ANDA 87-500 Aminophylline Tablets USP, 100 mg Roxane Laboratories, Inc. ANDA 87-501 Aminophylline Tablets USP, 200 mg Do. ANDA 88-253 T-Phyl (theophylline) Extended-Release Tablets, 200 mg The Purdue Frederick Co. Therefore, under section 505(e), of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(e)), and under authority delegated to the Director, Center for Drug Evaluation and Research, by the Commissioner of Food and Drugs, approval of the applications listed in the table in this document, and all amendments and supplements thereto, is hereby withdrawn, effective June 16, 2006. Dated: May 23, 2006. Douglas C. Throckmorton, Deputy Director, Center for Drug Evaluation and Research. [FR Doc. E6-9440 Filed 6-15-06; 8:45 am] BILLING CODE 4160-01-S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 2003E-0254] Determination of Regulatory Review Period for Purposes of Patent Extension; INSPRA AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration

(FDA)has determined the regulatory review period for INSPRA 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 INSPRA (eplerenone). INSPRA is indicated for the treatment of hypertension. Subsequent to this approval, the Patent and Trademark Office received a patent term restoration application for INSPRA (U.S. Patent No. 4,559,332) from Novartis Corp., and the Patent and Trademark Office requested FDA's assistance in determining this patent's eligibility for patent term restoration. In a letter dated June 16, 2003, FDA advised the Patent and Trademark Office that this human drug product had undergone a regulatory review period and that the approval of INSPRA 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 INSPRA is 2,135 days. Of this time, 1,832 days occurred during the testing phase of the regulatory review period, while 303 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: November 24, 1996. FDA has verified the applicant's claim that the date the investigational new drug application became effective was on November 24, 1996. 2. The date the application was initially submitted with respect to the human drug product under section 505(b) of the act: November 29, 2001. FDA has verified the applicant's claim that the new drug application

(NDA)for Inspra (NDA 21-437) was initially submitted on November 29, 2001. 3. The date the application was approved: September 27, 2002. FDA has verified the applicant's claim that NDA 21-437 was approved on September 27, 2002. 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 1,218 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 August 15, 2006. 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 December 13, 2006. 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: May 17, 2006. Jane A. Axelrad, Associate Director for Policy, Center for Drug Evaluation and Research. [FR Doc. E6-9412 Filed 6-15-06; 8:45 am] BILLING CODE 4160-01-S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 2006E-0022] Determination of Regulatory Review Period for Purposes of Patent Extension; SYMLIN AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration

(FDA)has determined the regulatory review period for SYMLIN 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-007), 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 SYMLIN (pramlintide acetate). SYMLIN is given at mealtimes and is indicated for Type 1 diabetes, as an adjunct treatment in patients who use mealtime insulin therapy and who have failed to achieve desired glucose control despite optimal insulin therapy, and for Type 2 diabetes, as an adjunct treatment in patients who use mealtime insulin therapy and who have failed to achieve desired glucose control despite optimal insulin therapy, with or without a concurrent sulfonylurea agent and/or metformin. Subsequent to this approval, the Patent and Trademark Office received a patent term restoration application for SYMLIN (U.S. Patent No. 5,686,411) from Amylin Pharmaceuticals, and the Patent and Trademark Office requested FDA's assistance in determining this patent's eligibility for patent term restoration. In a letter dated February 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 SYMLIN 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 SYMLIN is 4,620 days. Of this time, 3,060 days occurred during the testing phase of the regulatory review period, while 1,560 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* : July 24, 1992. The applicant claims July 29, 1992, as the date the investigational new drug application

(IND)became effective. However, FDA records indicate that the IND effective date was July 24, 1992, 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* : December 8, 2000. The applicant claims December 7, 2000, as the date the new drug application

(NDA)for Symlin (NDA 21-332) was initially submitted. However, FDA records indicate that NDA 21-332 was submitted on December 8, 2000. 3. *The date the application was approved* : March 16, 2005. FDA has verified the applicant's claim that NDA 21-332 was approved on March 16, 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 1,586 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 August 15, 2006. 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 December 13, 2006. 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: May 17, 2006. Jane A. Axelrad, Associate Director for Policy, Center for Drug Evaluation and Research. [FR Doc. E6-9414 Filed 6-15-06; 8:45 am] BILLING CODE 4160-01-S DEPARTMENT OF HEALTH AND HUMAN SERVICES Health Resources and Services Administration Response to Solicitation on Organ Procurement and Transplantation Network

(OPTN)Living Donor Guidelines AGENCY: Health Resources and Services Administration (HRSA), HHS. ACTION: Response to solicitation of comments. SUMMARY: A notice was published in the **Federal Register** on January 23, 2006 (Vol. 71, No. 14, pages 3519-3520). The purpose of this notice was to solicit comments to assist HRSA in determining whether criteria developed by the Organ Procurement and Transplantation Network

(OPTN)concerning organs procured from living donors, including those concerning the allocation of organs from living donors, should be given the same status, and be subject to the same enforcement actions, as other OPTN policies. FOR FURTHER INFORMATION CONTACT: James F. Burdick, M.D., Director, Division of Transplantation, Healthcare Systems Bureau, Health Resources and Services Administration, Parklawn Building, Room 12C-06, 5600 Fishers Lane, Rockville, Maryland 20857; telephone

(301)443-7577; fax

(301)594-6095; or e-mail: *jburdick@hrsa.gov* . SUPPLEMENTARY INFORMATION: Congress has provided specific authority under sections 372 of the Public Health Service

(PHS)Act, as amended, 42 U.S.C. 274 for the creation of a national OPTN, which is, among other things, to facilitate a donor and recipient matching system; establish membership criteria and medical criteria for allocating donated organs; and provide opportunities to members of the public to comment with respect to proposed criteria. The OPTN Final Rule (42 CFR part 121) governs the operations of the OPTN and is intended to help achieve the most equitable and medically effective use of human organs that are donated in trust for transplantation. Under the final rule, the OPTN is to develop policies on a variety of issues, including “[p]olicies for the equitable allocation of cadaveric organs [now referred to as deceased donor organs].” 42 CFR 121.4(a)(1). Under the final rule, allocation policies developed by the OPTN under section 121.8 of the final rule will be considered enforceable when and if the Secretary approves the policies as such. Enforceable OPTN policies are subject to the sanctions described in section 121.10(c)(1) of the final rule. Non-enforceable OPTN policies may still be subject to lesser sanctions by the OPTN ( *e.g.* , an OPTN member being designated a Member Not in Good Standing). Although the authorizing statute does not distinguish between transplants using organs from living donors and those using organs from deceased donors, the final rule does not include a requirement that the OPTN develop policies concerning the equitable allocation of living donor organs. Until recently, OPTN policies have predominantly focused on issues related to organ donation and transplantation of deceased donor organs. However, several widely publicized living donor deaths have caused the OPTN to implement new practices of reviewing and approving, on an advisory basis, the qualifications of living donor transplant programs. Additionally, the increased incidence of altruistic living donations has prompted the OPTN to consider policies that are patient-focused yet address the unique circumstances pertaining to the recovery and transplantation of living donor organs. Section 121.4(a)(6) of the final rule provides that the OPTN shall be responsible for developing policies on a variety of topics, including “[p]olicies on such matters as the Secretary directs.” In accordance with that authority, the Healthcare Systems Bureau directed the OPTN to develop allocation guidelines for organs from living donors and other policies necessary and appropriate to promote the safety and efficacy of living donor transplantation for the donor and recipient. It further advised the OPTN that all living donation policies (other than data reporting policies) should be considered as best practices or voluntary guidelines and not subject to regular OPTN sanctions (even those available with respect to violation of non-enforceable policies) until the public has had an opportunity to comment on the matter. In the January 23, 2006, **Federal Register** notice, comments were requested to assist HRSA in determining whether OPTN living donor guidelines should be given the same status of other OPTN policies, *i.e.* , be treated as policies developed in accordance with 42 CFR 121.8, and be subject to the same enforcement actions. The Secretary explained that if he decided these questions in the affirmative, OPTN policies relating to living donors would be treated the same as other OPTN policies developed in accordance with section 121.8 of the final rule. In other words, OPTN policies concerning living donors would not be considered enforceable policies under section 121.10 of the final rule, and violations of such policies would not be subject to the sanctions described in section 121.10(c)(1), unless and until the Secretary approved such policies as enforceable. During the comment period, HRSA received 29 comments from individuals affiliated with or representing universities, hospitals, professional associations, and living donation advocacy organizations; a healthcare accreditation organization; transplant recipients; and family members of donors, recipients and candidates. Twenty of these comments explicitly referenced changing the status of OPTN living donor guidelines. The remaining nine comments expressed views about various aspects of the national transplant system not directly related to the solicitation of comments. HRSA thanks the respondents for the quality and thoroughness of their comments. The comments and HRSA's decision are discussed below. I. Living Donor OPTN Policies Consistent With Other OPTN Policies The majority of respondents indicated that OPTN living donor guidelines should be given the same status of other OPTN policies. Of the 20 comments that explicitly referenced changing the status of OPTN living donor guidelines, 17 were supportive of giving OPTN living donor guidelines the same status, and subjecting these to the same enforcement actions, as other OPTN policies. Supportive comments were received from representatives of academia, transplant surgeons, living donors who had positive donation experiences, living donors who had negative donation experiences, family members of living donors who died or who experienced complications as a result of the donation, living donation advocacy organizations, transplant administrators, the professional societies representing transplant surgeons and transplant physicians, transplant candidate/recipient advocacy organizations, the organization serving as the current OPTN contractor, and an organization that accredits hospitals. Supportive comments cited the appropriateness of OPTN involvement in policies relating to living donors, including donor evaluation, informed consent, evaluation of surgical outcomes and complications, protection of living donors, peri-operative care, organ allocation, qualifications of transplant programs, and transplant program compliance with living donor policies. A few comments indicated opposition to giving OPTN living donor guidelines the same status as other OPTN policies. A family member of two kidney transplant candidates who died on the waiting list is now an advocate of potential living donors and recipients meeting on the Internet and is opposed to the OPTN's involvement in living donor policy making because of the perception that the OPTN discourages living donor transplants resulting from such meetings. Another opponent of OPTN involvement is waiting for a liver transplant and does not trust the OPTN policymaking process because of the perception that wealthier candidates receive priority for donor organs. One data manager from a large transplant program commented that mandating data collection on living donors was unlikely to increase donor follow-up form completion rates unless the donors' insurance companies can be persuaded to pay for follow-up visits. HRSA appreciates each of these comments. II. OPTN Living Donor Policy Making Authority—Organ Allocation Comments supportive of OPTN involvement in living donor policy making expressed varying views regarding the scope of policies the OPTN should consider. Of the 17 comments that were supportive of OPTN involvement, five suggested areas in which the OPTN should not become involved. One comment did not advocate an intrusive role for the OPTN in the allocation of living donor organs or ethical review of local living donor practices. A transplant administrator offered the similar caution that altruistic living donors may feel a sense of connection to their local transplant center and may not want their organs allocated to a distant center. A representative of the professional society for transplant surgeons offered a comment to HRSA that the OPTN Final Rule does not authorize the OPTN to establish policies for living donor organ allocation. In response to this, HRSA emphasizes that its authority to direct the OPTN to develop living donor organ allocation policies is granted in § 121.4(a)(6) of the OPTN Final Rule which permits the Secretary to develop policies on such other matters as the Secretary directs. The wording in § 121.8(a) of the final rule referring to policies “for the equitable allocation of cadaveric organs” should not be construed as a limitation of the Secretary's policy making authority over living donation. A representative of a living donor advocacy organization commented that OPTN policies should not interfere with the right of an altruistic living donor to direct their organ to a specific individual. We agree. Section 121.8(h) of the OPTN Final Rule permits the allocation of an organ to a recipient named by those authorized to make the donation. Because we are directing the OPTN to develop living donor allocation policies under section 121.8 of the final rule, section 121.8(h) will apply to living donation equally as it applies to deceased donation. III. OPTN Living Donor Policy Making Authority—Donor Evaluation Supportive comments varied in their level of support for OPTN involvement in developing policies for living donor evaluation. Of the 17 comments that were supportive, two were opposed to OPTN policymaking in this area. One comment from a representative of the professional organization for transplant surgeons and another from a transplant surgeon asserted that the OPTN should not develop policy in the area of donor evaluation because there is no clear clinical consensus regarding the policies or standards that should be followed. HRSA believes it is very likely that should the OPTN consider policy making in the area of living donor evaluation that members of OPTN committees and the Board of Directors will consider this perspective and abandon policy making in the absence of clear clinical consensus. Additionally, through its public comment process transplant professionals also have the opportunity to advise the OPTN of the lack of clear clinical consensus, should it exist. IV. OPTN Living Donor Policy Making—Living Donor Follow-up Several comments stated greater attention should be given to understanding the impact of donation on living donors. One commenter who represents the professional organization for transplant professionals recommended more Federal funding for a live organ donor database. A comment from a living donor who is a healthcare professional and living donor advocate asserted that there should be mandatory policies to protect living donors and a central source of outcome data via a living donor registry. A comment from a transplant surgeon supports more OPTN involvement in living donor data collection and monitoring living donor outcomes. A comment from a representative of a healthcare accreditation organization stated it is appropriate for the OPTN to establish additional policies to promote the safety of living donor transplantation. A comment from the mother of a living donor and recipient who both experienced post-transplant complications asserted that stronger policies should be developed to ensure living donor safety. Conclusion HRSA has reviewed and considered each aspect of each comment and has determined that OPTN living donor guidelines should be given the same status of other OPTN policies as discussed in the **Federal Register** Notice published on January 23, 2006. Under 42 CFR 121.4(a)(6), the Secretary directs the OPTN to develop policies regarding living organ donors and living organ donor recipients, including policies for the equitable allocation of living donor organs, in accordance with section 121.8 of the final rule. Thus, the OPTN shall develop such policies in the same manner, and with the same public comment process, that it does for policies on deceased organ donors and deceased organ donor recipients. Non-compliance with such policies shall subject OPTN members to the same consequences as noncompliance with policies concerning deceased organ donors and deceased organ donor recipients developed under the final rule. Dated: June 9, 2006. Elizabeth M. Duke, Administrator. [FR Doc. E6-9401 Filed 6-15-06; 8:45 am] BILLING CODE 4165-15-P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Human Genome Research Institute; Notice of Closed Meeting Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. Appendix 2), notice is hereby given of the following meeting. The meeting will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy. *Name of Committee:* National Human Genome Research Institute Special Emphasis Panel; Sequencing Centers Review. *Date:* July 13, 2006. *Time:* 8 a.m. to 5 p.m. *Agenda:* To review and evaluate grant applications. *Place:* The Hotel Rouge, 1315 16th Street, NW., Washington, DC 20036. *Contact Person:* Rudy O. Pozzatti, PhD, Scientific Review Administrator, Office of Scientific Review, National Human Geonome Research Institute, National Institutes of Health, Bethesda, MD 20892. 301-402-0838. (Catalogue of Federal Domestic Assistance Program Nos. 93.172, Human Genome Research, National Institutes of Health, HHS) Dated: June 12, 2006. Anna Snouffer, Acting Director, Office of Federal Advisory Committee Policy. [FR Doc. 06-5471 Filed 6-15-06; 8:45 am]

Connectionstraces to 6

Traces to 6 documents

U.S. Code

CFR