National Institute on Alcohol Abuse and Alcoholism; Notice of Closed Meeting, 45225 [E9-20862]

Download as PDF Federal Register / Vol. 74, No. 168 / Tuesday, September 1, 2009 / Notices individuals associated with the grant applications and/or contract proposals, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy. Name of Committee: National Advisory Child Health and Human Development Council. Date: September 21, 2009. Open: 8 a.m. to 12:30 p.m. Agenda: (1) A report by the Director, NICHD; (2) and annual review of the Division of Intramural Research; (3) Intellectual and Developmental Disabilities Branch Presentation; and other business of the Council. Place: National Institutes of Health, Building 31, 31 Center Drive, C–Wing, Conference Room 6, Bethesda, MD 20892. Closed: 1:30 p.m. to 5 p.m. Agenda: To review and evaluate grant applications and/or proposals. Place: National Institutes of Health, Building 31, 31 Center Drive, C–Wing, Conference Room 6, Bethesda, MD 20892. Contact Person: Yvonne T. Maddox, PhD, Deputy Director, National Institute of Child Health, and Human Development, NIH, 9000 Rockville Pike MSC 7510, Building 31, Room 2A03, Bethesda, MD 20892, (301) 496–1848. Any interested person may file written comments with the committee by forwarding the statement to the Contact Person listed on this notice. The statement should include the name, address, telephone number and when applicable, the business or professional affiliation of the interested person. In the interest of security, NIH has instituted stringent procedures for entrance onto the NIH campus. All visitor vehicles, including taxicabs, hotel, and airport shuttles will be inspected before being allowed on campus. Visitors will be asked to show one form of identification (for example, a government-issued photo ID, driver’s license, or passport) and to state the purpose of their visit. Information is also available on the Institute’s/Center’s home page: https:// www.nichd.nih.gov/about/nachhd.htm, where an agenda and any additional information for the meeting will be posted when available. mstockstill on DSKH9S0YB1PROD with NOTICES (Catalogue of Federal Domestic Assistance Program Nos. 93.864, Population Research; 93.865, Research for Mothers and Children; 93.929, Center for Medical Rehabilitation Research; 93.209, Contraception and Infertility Loan Repayment Program, National Institutes of Health, HHS) Dated: August 25, 2009. Jennifer Spaeth, Director, Office of Federal Advisory Committee Policy. [FR Doc. E9–21045 Filed 8–31–09; 8:45 am] DEPARTMENT OF HEALTH AND HUMAN SERVICES DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Food and Drug Administration National Institute on Alcohol Abuse and Alcoholism; Notice of Closed Meeting [Docket No. FDA–2009–E–0058] Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of the following meeting. The meeting will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy. Name of Committee: National Institute on Alcohol Abuse and Alcoholism, Initial Review Group; Clinical, Treatment and Health Services Research Review Subcommittee. Date: October 13–14, 2009. Time: 8:30 a.m to 5 p.m. Agenda: To review and evaluate grant applications. Place: Embassy Suites Hotel at the Chevy Chase Pavilion, 4300 Military Road, NW., Washington, DC. Contact Person: Katrina L. Foster, PhD, Scientific Review Officer, National Institute on Alcohol Abuse & Alcoholism, National Institutes of Health, 5635 Fishers Lane, Rm. 2019, Rockville, MD 20852. 301–443–4032, katrina@mail.nih.gov. (Catalogue of Federal Domestic Assistance Program Nos. 93.271, Alcohol Research Career Development Awards for Scientists and Clinicians; 93.272, Alcohol National Research Service Awards for Research Training; 93.273, Alcohol Research Programs; 93.891, Alcohol Research Center Grants; 93.701, ARRA Related Biomedical Research and Research Support Awards, National Institutes of Health, HHS). Dated: August 24, 2009. Jennifer Spaeth, Director, Office of Federal Advisory Committee Policy. [FR Doc. E9–20862 Filed 8–31–09; 8:45 am] BILLING CODE 4140–01–M BILLING CODE 4140–01–P VerDate Nov<24>2008 17:18 Aug 31, 2009 Jkt 217001 45225 PO 00000 Frm 00067 Fmt 4703 Sfmt 4703 Determination of Regulatory Review Period for Purposes of Patent Extension; TAPENTADOL HYDROCHLORIDE AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) has determined the regulatory review period for TAPENTADOL HYDROCHLORIDE 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 https:// www.regulations.gov. FOR FURTHER INFORMATION CONTACT: Beverly Friedman, Office of Regulatory Policy, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, rm. 6222, Silver Spring, MD 20993– 0002, 301–796–3602. 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 drug 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 E:\FR\FM\01SEN1.SGM 01SEN1

Agencies

[Federal Register Volume 74, Number 168 (Tuesday, September 1, 2009)]
[Notices]
[Page 45225]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-20862]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


National Institute on Alcohol Abuse and Alcoholism; Notice of 
Closed Meeting

    Pursuant to section 10(d) of the Federal Advisory Committee Act, as 
amended (5 U.S.C. App.), notice is hereby given of the following 
meeting.
    The meeting will be closed to the public in accordance with the 
provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 
U.S.C., as amended. The grant applications and the discussions could 
disclose confidential trade secrets or commercial property such as 
patentable material, and personal information concerning individuals 
associated with the grant applications, the disclosure of which would 
constitute a clearly unwarranted invasion of personal privacy.

    Name of Committee: National Institute on Alcohol Abuse and 
Alcoholism, Initial Review Group; Clinical, Treatment and Health 
Services Research Review Subcommittee.
    Date: October 13-14, 2009.
    Time: 8:30 a.m to 5 p.m.
    Agenda: To review and evaluate grant applications.
    Place: Embassy Suites Hotel at the Chevy Chase Pavilion, 4300 
Military Road, NW., Washington, DC.
    Contact Person: Katrina L. Foster, PhD, Scientific Review 
Officer, National Institute on Alcohol Abuse & Alcoholism, National 
Institutes of Health, 5635 Fishers Lane, Rm. 2019, Rockville, MD 
20852. 301-443-4032, katrina@mail.nih.gov.

(Catalogue of Federal Domestic Assistance Program Nos. 93.271, 
Alcohol Research Career Development Awards for Scientists and 
Clinicians; 93.272, Alcohol National Research Service Awards for 
Research Training; 93.273, Alcohol Research Programs; 93.891, 
Alcohol Research Center Grants; 93.701, ARRA Related Biomedical 
Research and Research Support Awards, National Institutes of Health, 
HHS).

    Dated: August 24, 2009.
Jennifer Spaeth,
Director, Office of Federal Advisory Committee Policy.
[FR Doc. E9-20862 Filed 8-31-09; 8:45 am]
BILLING CODE 4140-01-M

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