Center for Scientific Review; Notice of Closed Meetings, 8885-8886 [08-687]

Download as PDF Federal Register / Vol. 73, No. 32 / Friday, February 15, 2008 / Notices studies that should be conducted for drug metabolites that are present at greater than 10 percent of the parent drug systemic exposure as measured in plasma. A draft version of this guidance was made available for public comment in 2005 (70 FR 32839, June 6, 2005). All of the public comments we received have been considered and the guidance was revised as appropriate. 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 the safety testing of drug metabolites. 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. II. Comments Interested persons may submit to the Division of Dockets Management (see ADDRESSES) written or electronic comments regarding this document. Submit a single copy of electronic comments or two paper copies of any mailed comments, except that individuals may submit one paper copy. Comments are to be identified 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. Please note that on January 15, 2008, the FDA Web site transitioned to the Federal Dockets Management System (FDMS). FDMS is a Government-wide, electronic docket management system. Electronic submissions will be accepted by FDA through FDMS only. III. Electronic Access Persons with access to the Internet may obtain the document at either https://www.fda.gov/cder/guidance/ index.htm or https://www.fda.gov/ ohrms/dockets/default.htm. Dated: February 8, 2008. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. E8–2827 Filed 2–14–08; 8:45 am] rwilkins on PROD1PC63 with NOTICES BILLING CODE 4160–01–S DEPARTMENT OF HEALTH AND HUMAN SERVICES DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration National Institutes of Health Anti-Infective Drugs Advisory Committee; Amendment of Notice Center for Scientific Review; Notice of Closed Meetings AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing an amendment to the notice of a meeting of the Anti-Infective Drugs Advisory Committee. This meeting was announced in the Federal Register of January 11, 2008 (73 FR 2055). The amendment is being made to reflect a change in the Date and Time and Agenda portions of the document. There are no other changes. FOR FURTHER INFORMATION CONTACT: Sohail Mosaddegh, Center for Drug Evaluation and Research (HFD–21), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301–827–7001, or FDA Advisory Committee Information Line, 1–800– 741–8138 (301–443–0572 in the Washington, DC area), code 3014512530. Please call the Information Line for up-to-date information on this meeting. In the Federal Register of January 11, 2008, FDA announced that a meeting of the Anti-Infective Drugs Advisory Committee would be held on February 27 and 28, 2008. On page 2056, in the first column, the Date and Time and Agenda portions are amended to read as follows: Date and Time: The meeting will be held on February 27, 2008, from 8 a.m. to 5 p.m. Agenda: On February 27, 2008, the committee will discuss new drug application (NDA) 022–110, telavancin powder for reconstitution and intravenous administration, Theravance, Inc., proposed for the treatment of complicated skin and skin structure infection. This notice is issued under the Federal Advisory Committee Act (U.S.C. app. 2) and 21 CFR part 14, relating to advisory committees. SUPPLEMENTARY INFORMATION: Dated: February 11, 2008. Randall W. Lutter, Deputy Commissioner for Policy. [FR Doc. E8–2824 Filed 2–14–08; 8:45 am] BILLING CODE 4160–01–S VerDate Aug<31>2005 15:58 Feb 14, 2008 Jkt 214001 8885 PO 00000 Frm 00042 Fmt 4703 Sfmt 4703 Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. Appendix 2), notice is hereby given of the following meetings. The meetings will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy. Name of Committee: Center for Scientific Review Special Emphasis Panel, Molecular and Cellular Sciences Special Emphasis Panel. Date: February 28, 2008. Time: 11 a.m. to 2 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, 6701 Rockledge Drive, Bethesda, MD 20892, (Telephone Conference Call). Contact Person: Noni Byrnes, PhD, Scientific Review Administrator, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 5130, MSC 7840, Bethesda, MD 20892, (301) 435– 1023, byrnesn@csr.nih.gov. This notice is being published less than 15 days prior to the meeting due to the timing limitations imposed by the review and funding cycle. Name of Committee: Center for Scientific Review Special Emphasis Panel, Member Conflict: Stress. Date: February 29, 2008. Time: 12 p.m. to 2 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, 6701 Rockledge Drive, Bethesda, MD 20892, (Telephone Conference Call). Contact Person: Christine L. Melchior, PhD, Scientific Review Administrator, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 5176, MSC 7844, Bethesda, MD 20892, (301) 435– 1713, melchioc@csr.nih.gov. This notice is being published less than 15 days prior to the meeting due to the timing limitations imposed by the review and funding cycle. Name of Committee: Center for Scientific Review Special Emphasis Panel, Member Conflict: Innate Immunity and Inflammation. Date: March 7, 2008. Time: 10 a.m. to 12 p.m. Agenda: To review and evaluate grant applications. E:\FR\FM\15FEN1.SGM 15FEN1 rwilkins on PROD1PC63 with NOTICES 8886 Federal Register / Vol. 73, No. 32 / Friday, February 15, 2008 / Notices Place: National Institutes of Health, 6701 Rockledge Drive, Bethesda, MD 20892, (Telephone Conference Call). Contact Person: Betty Hayden, PhD, Scientific Review Administrator, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 4206, MSC 7812, Bethesda, MD 20892, 301–435– 1223, haydenb@csr.nih.gov. Name of Committee: Center for Scientific Review Special Emphasis Panel, Red Cell Cytoskeleton. Date: March 10, 2008. Time: 3 p.m. to 4:30 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, 6701 Rockledge Drive, Bethesda, MD 20892. (Telephone Conference Call). Contact Person: Manjit Hanspal, PhD, Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 4138, MSC 7804, Bethesda, MD 20892, 301–435– 1195. Name of Committee: Center for Scientific Review Special Emphasis Panel, Neuroimmunology and Neurological Disorders. Date: March 12, 2008. Time: 3 p.m. to 6 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, 6701 Rockledge Drive, Bethesda, MD 20892. (Telephone Conference Call). Contact Person: Vilen A. Movsesyan, PhD, Scientific Review Administrator, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 4040M, MSC 7806, Bethesda, MD 20892, 301–402– 7278, movsesyanv@csr.nih.gov. Name of Committee: Center for Scientific Review Special Emphasis Panel, Parasites. Date: March 13, 2008. Time: 12:30 p.m. to 3:30 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, 6701 Rockledge Drive, Bethesda, MD 20892 (Telephone Conference Call). Contact Person: Marian Wachtel, PhD, Scientific Review Administrator, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 3208, MSC 7858, Bethesda, MD 20892, 301–435– 1148, wachtelm@csr.nih.gov. Name of Committee: Center for Scientific Review Special Emphasis Panel, Fellowships. Date: March 20–21, 2008. Time: 9 a.m. to 10 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, 6701 Rockledge Drive, Bethesda, MD 20892 (Virtual Meeting). Contact Person: Malgorzata Klosek, PhD, Scientific Review Administrator, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 4188, MSC 7849, Bethesda, MD 20892, 301–435– 2211, klosekm@csr.nih.gov. Name of Committee: Center for Scientific Review Special Emphasis Panel, Member VerDate Aug<31>2005 15:58 Feb 14, 2008 Jkt 214001 Conflict: Oral, Dental and Craniofacial Sciences. Date: March 20, 2008. Time: 2 p.m. to 6 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, 6701 Rockledge Drive, Bethesda, MD 20892 (Telephone Conference Call). Contact Person: J. Terrell Hoffeld, DDS, PhD, Dental Officer, USPHS, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 4116, MSC 7816, Bethesda, MD 20892, 301–435– 1781, th88q@nih.gov. Name of Committee: Center for Scientific Review Special Emphasis Panel, Small Business Grant Applications: Immunology. Date: March 21, 2008. Time: 8:30 a.m. to 6 p.m. Agenda: To review and evaluate grant applications. Place: State Plaza Hotel, 2117 E Street, NW., Washington, DC 20037. Contact Person: Stephen M. Nigida, PhD, Health Scientist Administrator, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 4212, MSC 7812, Bethesda, MD 20892. 301–435– 1222, nigidas@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: February 8, 2008. Jennifer Spaeth, Director, Office of Federal Advisory Committee Policy. [FR Doc. 08–687 Filed 2–14–08; 8:45 am] BILLING CODE 4140–01–M DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Cancer Institute; Notice of Closed Meetings Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. Appendix 2), notice is hereby given of the following meetings. The meetings will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and/or contract proposals 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. PO 00000 Frm 00043 Fmt 4703 Sfmt 4703 Name of Committee: National Cancer Institute Special Emphasis Panel; Development of Anticancer Agents. Date: March 7, 2008. Time: 8:30 a.m. to 5 p.m. Agenda: To review and evaluate contract proposals. Place: The Legacy Rockville, 1775 Rockville Pike, Rockville, MD 20852. Contact Person: Joyce C. Pegues, PhD, Scientific Review Officer, Special Review and Logistics Branch, Division of Extramural Activities, NIH National Cancer Institute, 6116 Executive Boulevard, Room 7149, Bethesda, MD 20892–8329, 301–594–1286, peguesj@mail.nih.gov. Name of Committee: National Cancer Institute Special Emphasis Panel; Pharmacodynamic Assays. Date: March 11, 2008. Time: 8 a.m. to 5 p.m. Agenda: To review and evaluate contract proposals. Place: The Legacy Hotel and Meeting Center, Bethesda, MD 20852. Contact Person: Thomas M. Vollberg, PhD, Scientific Review Officer, Special Review and Logistics Branch, Division of Extramural Activities, National Cancer Institute, 6116 Executive Boulevard, Room 7142, Bethesda, MD 20892, 301–594–9582, vollbert@mail.nih.gov. Name of Committee: National Cancer Institute Special Emphasis Panel; Small Grants for Behavioral Research in Cancer Control. Date: March 12, 2008. Time: 8 a.m. to 7 p.m. Agenda: To review and evaluate grant applications. Place: Ramada Inn Rockville, 1775 Rockville Pike, Rockville, MD 20852. Contact Person: Rhonda J. Moore, PhD, Scientific Review Officer, Special Review and Logistics Branch, Division of Extramural Activities, National Cancer Institute, NIH, 6116 Executive Boulevard, Room 7151, Bethesda, MD 20892–8329, 301–451–9385, moorerh@mail.nih.gov. Name of Committee: National Cancer Institute Special Emphasis Panel; Biopsy Instruments and Devices that Preserve Molecular Profiles in Tumors. Date: March 14, 2008. Time: 10:30 a.m. to 5 p.m. Agenda: To review and evaluate contract proposals. Place: National Institutes of Health, 6130 Executive Blvd., Conference Room J, Rockville, MD 20851, (Telephone Conference Call). Contact Person: Kenneth L. Bielat, PhD, Scientific Review Officer, Special Review Logistics Branch, Division of Extramural Activities, National Cancer Institute, 6116 Executive Boulevard, Room 7147, Bethesda, MD 20892–8329, 301–496–7576, bielatk@mail.nih.gov. Name of Committee: National Cancer Institute Special Emphasis Panel; Advanced Genomic Data Analysis and Visualization Methods for TCGA Data. Date: April 2, 2008. Time: 8 a.m. to 5 p.m. Agenda: To review and evaluate grant applications. E:\FR\FM\15FEN1.SGM 15FEN1

Agencies

[Federal Register Volume 73, Number 32 (Friday, February 15, 2008)]
[Notices]
[Pages 8885-8886]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 08-687]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Center for Scientific Review; Notice of Closed Meetings

    Pursuant to section 10(d) of the Federal Advisory Committee Act, as 
amended (5 U.S.C. Appendix 2), notice is hereby given of the following 
meetings.
    The meetings will be closed to the public in accordance with the 
provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 
U.S.C., as amended. The grant applications and the discussions could 
disclose confidential trade secrets or commercial property such as 
patentable material, and personal information concerning individuals 
associated with the grant applications, the disclosure of which would 
constitute a clearly unwarranted invasion of personal privacy.

    Name of Committee: Center for Scientific Review Special Emphasis 
Panel, Molecular and Cellular Sciences Special Emphasis Panel.
    Date: February 28, 2008.
    Time: 11 a.m. to 2 p.m.
    Agenda: To review and evaluate grant applications.
    Place: National Institutes of Health, 6701 Rockledge Drive, 
Bethesda, MD 20892, (Telephone Conference Call).
    Contact Person: Noni Byrnes, PhD, Scientific Review 
Administrator, Center for Scientific Review, National Institutes of 
Health, 6701 Rockledge Drive, Room 5130, MSC 7840, Bethesda, MD 
20892, (301) 435-1023, byrnesn@csr.nih.gov.
    This notice is being published less than 15 days prior to the 
meeting due to the timing limitations imposed by the review and 
funding cycle.

    Name of Committee: Center for Scientific Review Special Emphasis 
Panel, Member Conflict: Stress.
    Date: February 29, 2008.
    Time: 12 p.m. to 2 p.m.
    Agenda: To review and evaluate grant applications.
    Place: National Institutes of Health, 6701 Rockledge Drive, 
Bethesda, MD 20892, (Telephone Conference Call).
    Contact Person: Christine L. Melchior, PhD, Scientific Review 
Administrator, Center for Scientific Review, National Institutes of 
Health, 6701 Rockledge Drive, Room 5176, MSC 7844, Bethesda, MD 
20892, (301) 435-1713, melchioc@csr.nih.gov.
    This notice is being published less than 15 days prior to the 
meeting due to the timing limitations imposed by the review and 
funding cycle.

    Name of Committee: Center for Scientific Review Special Emphasis 
Panel, Member Conflict: Innate Immunity and Inflammation.
    Date: March 7, 2008.
    Time: 10 a.m. to 12 p.m.
    Agenda: To review and evaluate grant applications.

[[Page 8886]]

    Place: National Institutes of Health, 6701 Rockledge Drive, 
Bethesda, MD 20892, (Telephone Conference Call).
    Contact Person: Betty Hayden, PhD, Scientific Review 
Administrator, Center for Scientific Review, National Institutes of 
Health, 6701 Rockledge Drive, Room 4206, MSC 7812, Bethesda, MD 
20892, 301-435-1223, haydenb@csr.nih.gov.

    Name of Committee: Center for Scientific Review Special Emphasis 
Panel, Red Cell Cytoskeleton.
    Date: March 10, 2008.
    Time: 3 p.m. to 4:30 p.m.
    Agenda: To review and evaluate grant applications.
    Place: National Institutes of Health, 6701 Rockledge Drive, 
Bethesda, MD 20892. (Telephone Conference Call).
    Contact Person: Manjit Hanspal, PhD, Scientific Review Officer, 
Center for Scientific Review, National Institutes of Health, 6701 
Rockledge Drive, Room 4138, MSC 7804, Bethesda, MD 20892, 301-435-
1195.

    Name of Committee: Center for Scientific Review Special Emphasis 
Panel, Neuroimmunology and Neurological Disorders.
    Date: March 12, 2008.
    Time: 3 p.m. to 6 p.m.
    Agenda: To review and evaluate grant applications.
    Place: National Institutes of Health, 6701 Rockledge Drive, 
Bethesda, MD 20892. (Telephone Conference Call).
    Contact Person: Vilen A. Movsesyan, PhD, Scientific Review 
Administrator, Center for Scientific Review, National Institutes of 
Health, 6701 Rockledge Drive, Room 4040M, MSC 7806, Bethesda, MD 
20892, 301-402-7278, movsesyanv@csr.nih.gov.

    Name of Committee: Center for Scientific Review Special Emphasis 
Panel, Parasites.
    Date: March 13, 2008.
    Time: 12:30 p.m. to 3:30 p.m.
    Agenda: To review and evaluate grant applications.
    Place: National Institutes of Health, 6701 Rockledge Drive, 
Bethesda, MD 20892 (Telephone Conference Call).
    Contact Person: Marian Wachtel, PhD, Scientific Review 
Administrator, Center for Scientific Review, National Institutes of 
Health, 6701 Rockledge Drive, Room 3208, MSC 7858, Bethesda, MD 
20892, 301-435-1148, wachtelm@csr.nih.gov.

    Name of Committee: Center for Scientific Review Special Emphasis 
Panel, Fellowships.
    Date: March 20-21, 2008.
    Time: 9 a.m. to 10 p.m.
    Agenda: To review and evaluate grant applications.
    Place: National Institutes of Health, 6701 Rockledge Drive, 
Bethesda, MD 20892 (Virtual Meeting).
    Contact Person: Malgorzata Klosek, PhD, Scientific Review 
Administrator, Center for Scientific Review, National Institutes of 
Health, 6701 Rockledge Drive, Room 4188, MSC 7849, Bethesda, MD 
20892, 301-435-2211, klosekm@csr.nih.gov.

    Name of Committee: Center for Scientific Review Special Emphasis 
Panel, Member Conflict: Oral, Dental and Craniofacial Sciences.
    Date: March 20, 2008.
    Time: 2 p.m. to 6 p.m.
    Agenda: To review and evaluate grant applications.
    Place: National Institutes of Health, 6701 Rockledge Drive, 
Bethesda, MD 20892 (Telephone Conference Call).
    Contact Person: J. Terrell Hoffeld, DDS, PhD, Dental Officer, 
USPHS, Center for Scientific Review, National Institutes of Health, 
6701 Rockledge Drive, Room 4116, MSC 7816, Bethesda, MD 20892, 301-
435-1781, th88q@nih.gov.

    Name of Committee: Center for Scientific Review Special Emphasis 
Panel, Small Business Grant Applications: Immunology.
    Date: March 21, 2008.
    Time: 8:30 a.m. to 6 p.m.
    Agenda: To review and evaluate grant applications.
    Place: State Plaza Hotel, 2117 E Street, NW., Washington, DC 
20037.
    Contact Person: Stephen M. Nigida, PhD, Health Scientist 
Administrator, Center for Scientific Review, National Institutes of 
Health, 6701 Rockledge Drive, Room 4212, MSC 7812, Bethesda, MD 
20892. 301-435-1222, nigidas@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: February 8, 2008.
Jennifer Spaeth,
Director, Office of Federal Advisory Committee Policy.
[FR Doc. 08-687 Filed 2-14-08; 8:45 am]
BILLING CODE 4140-01-M
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