National Institute on Alcohol Abuse and Alcoholism; Notice of Closed Meeting, 26308-26309 [2011-11175]

Download as PDF 26308 Federal Register / Vol. 76, No. 88 / Friday, May 6, 2011 / Notices Food and Drug Administration, 7520 Standish Pl., Rockville, MD 20855, 240– 276–8782. SUPPLEMENTARY INFORMATION: I. Background FDA is announcing the availability of a guidance for industry entitled ‘‘Submission of Summary Bioequivalence Data for ANDAs.’’ The guidance provides recommendations to applicants planning to include BE studies for submission in ANDAs. The guidance provides information on the following subjects: • Types of ANDA submissions covered by the regulations on BE studies; • Recommended format for summary reports of BE studies; and • Types of formulations the Agency considers to be the same drug product formulation for different dosage forms based on differences in composition. The guidance is applicable to BE studies conducted for ANDAs during both preapproval and postapproval periods. On April 17, 2009, FDA announced the availability of the draft version of this guidance (74 FR 17872). The public comment period closed on July 16, 2009. A few comments were received from the public, all of which the Agency considered carefully as it finalized the guidance and made appropriate changes. Changes to the guidance were minor and made to clarify statements in the draft guidance. This guidance is being issued consistent with FDA’s good guidance practices regulation (21 CFR 10.115). The guidance represents the Agency’s current thinking on submission of summary bioequivalence data for ANDAs. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. An alternative approach may be used if such approach satisfies the requirements of the applicable statutes and regulations. emcdonald on DSK2BSOYB1PROD with NOTICES II. Comments Interested persons may submit to the Division of Dockets Management (see ADDRESSES) either electronic or written comments regarding this document. It is only necessary to send one set of comments. It is no longer necessary to send two copies of mailed comments. Identify comments with the docket number found in brackets in the heading of this document. Received comments may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday. VerDate Mar<15>2010 17:26 May 05, 2011 Jkt 223001 BILLING CODE 4160–01–P Open: June 9, 2011, 9 a.m. to 3 p.m. Agenda: Presentation and other business of the council. Place: National Institutes of Health, 5635 Fishers Lane, Bethesda, MD 20892. Contact Person: Abraham P. Bautista, PhD, Executive Secretary, National Institute on Alcohol Abuse & Alcoholism National Institutes of Health, 5635 Fishers Lane, Rm 2085, Rockville, Md 20852, 301–443–9737, bautistaa@mail.nih.gov. Information is also available on the Institute’s/Center’s home page: silk.nih.gov/ silk/niaaa1/about/roster.htm, where an agenda and any additional information for the meeting will be posted when available. (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) DEPARTMENT OF HEALTH AND HUMAN SERVICES Dated: May 2, 2011. Jennifer S. Spaeth, Director, Office of Federal Advisory Committee Policy. III. Paperwork Reduction Act of 1995 This guidance refers to information collection provisions that are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501– 3520). The collections of information in 21 CFR 314.94(a)(7), 314.96(a)(1), and 314.97 have been approved under OMB control number 0910–0630. IV. Electronic Access Persons with access to the Internet may obtain the document at either https://www.fda.gov/Drugs/Guidance ComplianceRegulatoryInformation/ Guidances/default.htm or https://www. regulations.gov. Dated: May 2, 2011. Leslie Kux, Acting Assistant Commissioner for Policy. [FR Doc. 2011–11102 Filed 5–5–11; 8:45 am] [FR Doc. 2011–11170 Filed 5–5–11; 8:45 am] National Institutes of Health BILLING CODE 4140–01–P National Institute on Alcohol Abuse And Alcoholism; Notice of Meeting. Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of a meeting of the National Advisory Council on Alcohol Abuse and Alcoholism. The meeting will be open to the public as indicated below, with attendance limited to space available. Individuals who plan to attend and need special assistance, such as sign language interpretation or other reasonable accommodations, should notify the Contact Person listed below in advance of the 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 Advisory Council on Alcohol Abuse and Alcoholism. Date: June 8–9, 2011. Closed: June 8, 2011, 5:30 p.m. to 7:30 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, 5635 Fishers Lane, Bethesda, MD 20892. PO 00000 Frm 00070 Fmt 4703 Sfmt 4703 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, Epidemiology, Prevention and Behavior Research Review Subcommittee. Date: July 19, 2011. Time: 8 a.m. to 5 p.m. Agenda: To review and evaluate grant applications. Place: Hyatt Regency Bethesda, One Bethesda Metro Center, 7400 Wisconsin Avenue, Bethesda, MD 20814. E:\FR\FM\06MYN1.SGM 06MYN1 Federal Register / Vol. 76, No. 88 / Friday, May 6, 2011 / Notices Contact Person: Katrina L Foster, PhD, Scientific Review Administrator, National Institutes On Alcohol Abuse & Alcoholism National, Institutes Of Health, 5635 Fishers Lane, Rm. 3037, Rockville, Md 20852, 301– 443–3037, 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: May 2, 2011. Jennifer S. Spaeth, Director, Office of Federal Advisory Committee Policy. [FR Doc. 2011–11175 Filed 5–5–11; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Center for Scientific Review; Notice of Closed Meetings emcdonald on DSK2BSOYB1PROD with NOTICES 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 meetings. The meetings will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy. Name of Committee: Center for Scientific Review Special Emphasis Panel, Member Conflict: Auditory and Somatosensory Pain Neuroscience. Date: June 1–2, 2011. Time: 8 a.m. to 6 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, 6701 Rockledge Drive, Bethesda, MD 20892 (Virtual Meeting). Contact Person: John Bishop, PhD, Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 5182, MSC 7844, Bethesda, MD 20892, (301) 408– 9664, bishopj@csr.nih.gov. Name of Committee: Musculoskeletal, Oral And Skin Sciences Integrated Review Group, Oral, Dental and Craniofacial Sciences Study Section. Date: June 2–3, 2011. Time: 8 a.m. to 12 p.m. VerDate Mar<15>2010 17:26 May 05, 2011 Jkt 223001 Agenda:T o review and evaluate grant applications. Place: The Westin Long Beach, 333 East Ocean Boulevard, Long Beach, CA 90802. Contact Person: Yi-Hsin Liu, PhD, Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 4214, MSC 7814, Bethesda, MD 20892, 301–435– 1781, liuyh@csr.nih.gov. Name of Committee: Center for Scientific Review Special Emphasis Panel, Pathophysiology and Clinical Studies of Osteonecrosis of the Jaw. Date: June 3, 2011. Time: 12 p.m. to 5 p.m. Agenda: To review and evaluate grant applications. Place: The Westin Long Beach, 333 East Ocean Boulevard, Long Beach, CA 90802. Contact Person: Yi-Hsin Liu, PhD, Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 4214, MSC 7814, Bethesda, MD 20892, 301–435– 1781, liuyh@csr.nih.gov. Name of Committee: Vascular and Hematology Integrated Review Group, Vascular Cell and Molecular Biology Study Section. Date: June 6–7, 2011. Time: 8 a.m. to 1 p.m. Agenda: To review and evaluate grant applications. Place: The Embassy Suites Chicago O’ Hare, 5500 North River Road, Rosemont, IL 60018. Contact Person: Anshumali Chaudhari, PhD, Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 4124, MSC 7802, Bethesda, MD 20892, (301) 435– 1210, chaudhaa@csr.nih.gov. Name of Committee: Population Sciences and Epidemiology Integrated Review Group, Infectious Diseases, Reproductive Health, Asthma and Pulmonary Conditions Study Section. Date: June 6–7, 2011. Time: 8:30 a.m. to 5 p.m. Agenda: To review and evaluate grant applications. Place: Melrose Hotel, 2430 Pennsylvania Avenue, NW., Washington, DC 20037. Contact Person: Lisa Steele, PhD, Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 3139, MSC 7770, Bethesda, MD 20892, 301–594–6594, steeleln@csr.nih.gov. Name of Committee: Center for Scientific Review Special Emphasis Panel, PAR–11– 044: Indo-US Collaborative Program on LowCost Medical Devices. Date: June 8–9, 2011. Time: 11 a.m. to 6 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, 6701 Rockledge Drive, Bethesda, MD 20892 (Virtual Meeting). Contact Person: David R Filpula, PhD, Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 6181, MSC 7892, Bethesda, MD 20892, 301–435– 2902, filpuladr@mail.nih.gov. PO 00000 Frm 00071 Fmt 4703 Sfmt 4703 26309 Name of Committee: Center for Scientific Review Special Emphasis Panel, RM10–018: Technology Development for New Affinity Reagents Against the Human Proteome. Date: June 15, 2011. Time: 8 a.m. to 5 p.m. Agenda: To review and evaluate grant applications. Place: Hilton Alexandria Old Town, 1767 King Street, Alexandria, VA 22314. Contact Person: Joseph D Mosca, PhD, Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 5158, MSC 7808, Bethesda, MD 20892, (301) 435– 2344, moscajos@csr.nih.gov. (Catalogue of Federal Domestic Assistance Program Nos. 93.306, Comparative Medicine; 93.333, Clinical Research, 93.306, 93.333, 93.337, 93.393–93.396, 93.837–93.844, 93.846–93.878, 93.892, 93.893, National Institutes of Health, HHS) Dated: May 2, 2011. Jennifer S. Spaeth, Director, Office of Federal Advisory Committee Policy. [FR Doc. 2011–11177 Filed 5–5–11; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Cancer Institute; Notice 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 Cancer Institute Special Emphasis Panel, NCI Tumor Microenvironment (TMEN.) Date: June 29–July 1, 2011. Time: 8 a.m. to 5 p.m. Agenda: To review and evaluate grant applications. Place: Washington DC North Hilton Hotel, 620 Perry Parkway, Gaithersburg, MD 20877. Contact Person: Lalita D. Palekar, PhD, Scientific Review Officer, Special Review and Logistics Branch, Division of Extramural Activities, National Cancer Institute, 6116 Executive Boulevard, Room 7141, Bethesda, MD 20892, 301–496–7575, palekarl@mail.nih.gov. E:\FR\FM\06MYN1.SGM 06MYN1

Agencies

[Federal Register Volume 76, Number 88 (Friday, May 6, 2011)]
[Notices]
[Pages 26308-26309]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-11175]


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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, Epidemiology, Prevention and 
Behavior Research Review Subcommittee.
    Date: July 19, 2011.
    Time: 8 a.m. to 5 p.m.
    Agenda: To review and evaluate grant applications.
    Place: Hyatt Regency Bethesda, One Bethesda Metro Center, 7400 
Wisconsin Avenue, Bethesda, MD 20814.

[[Page 26309]]

    Contact Person: Katrina L Foster, PhD, Scientific Review 
Administrator, National Institutes On Alcohol Abuse & Alcoholism 
National, Institutes Of Health, 5635 Fishers Lane, Rm. 3037, 
Rockville, Md 20852, 301-443-3037, 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: May 2, 2011.
Jennifer S. Spaeth,
Director, Office of Federal Advisory Committee Policy.
[FR Doc. 2011-11175 Filed 5-5-11; 8:45 am]
BILLING CODE 4140-01-P
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