National Institute of Allergy and Infectious Diseases; Notice of Closed Meetings, 3472 [2010-1050]

Download as PDF jlentini on DSKJ8SOYB1PROD with NOTICES 3472 Federal Register / Vol. 75, No. 13 / Thursday, January 21, 2010 / Notices regions: The European Union, Japan, and the United States. The six ICH sponsors are the European Commission; the European Federation of Pharmaceutical Industries Associations; the Japanese Ministry of Health, Labour, and Welfare; the Japanese Pharmaceutical Manufacturers Association; the Centers for Drug Evaluation and Research and Biologics Evaluation and Research, FDA; and the Pharmaceutical Research and Manufacturers of America. The ICH Secretariat, which coordinates the preparation of documentation, is provided by the International Federation of Pharmaceutical Manufacturers Associations (IFPMA). The ICH Steering Committee includes representatives from each of the ICH sponsors and the IFPMA, as well as observers from the World Health Organization, Health Canada, and the European Free Trade Area. In the Federal Register of September 3, 2008 (73 FR 51491), FDA published a notice announcing the availability of a draft guidance entitled ‘‘M3(R2) Nonclinical Safety Studies for the Conduct of Human Clinical Trials and Marketing Authorization for Pharmaceuticals.’’ The notice gave interested persons an opportunity to submit comments by October 20, 2008. After consideration of the comments received and revisions to the guidance, a final draft of the guidance was submitted to the ICH Steering Committee and endorsed by the three participating regulatory agencies in June 2009. Guidance is provided on the various nonclinical studies recommended to support conduct of clinical trials and marketing. The guidance further harmonizes the recommendations in a number of areas and includes a new section on exploratory clinical trials. The recommendations should promote safe and ethical development and availability of new pharmaceuticals. The guidance reflects revisions made in response to comments received on the draft guidance. The revisions include more detailed discussions of some types of nonclinical studies and editorial changes to provide further clarification in a number of areas. 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 this topic. 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. VerDate Nov<24>2008 16:17 Jan 20, 2010 Jkt 220001 II. Comments Interested persons may submit to the Division of Dockets Management (see ADDRESSES) electronic or written comments on the guidance. 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. III. Electronic Access Persons with access to the Internet may obtain the document at https:// www.regulations.gov, https:// www.fda.gov/Drugs/Guidance ComplianceRegulatoryInformation/ Guidances/default.htm, or https:// www.fda.gov/BiologicsBloodVaccines/ GuidanceComplianceRegulatory Information/Guidances/default.htm. Dated: January 15, 2010. David Dorsey, Acting Deputy Commissioner for Policy, Planning and Budget. [FR Doc. 2010–1027 Filed 1–20–10; 8:45 am] BILLING CODE 4160–01–S Place: Holiday Inn Chevy Chase, 5520 Wisconsin Avenue, Chevy Chase, MD 20815. Contact Person: Gary S. Madonna, PhD, Scientific Review Officer, Scientific Review Program, Division of Extramural Activities, NIAID, National Institutes of Health, 6700B Rockledge Drive, MSC 7616, Bethesda, MD 20892, 301–496–3528, gm12w@nih.gov. Name of Committee: National Institute of Allergy and Infectious Diseases Special Emphasis Panel; NIAID Clinical Trial Planning (R34) Grants and Implementation (U01) Cooperative Agreements. Date: February 12, 2010. Time: 8 a.m. to 6 p.m. Agenda: To review and evaluate grant applications. Place: Crowne Plaza Hotel—Silver Spring, 8777 Georgia Avenue, Silver Spring, MD 20910. Contact Person: B. Duane Price, PhD, Scientific Review Officer, Scientific Review Program, HHS/NIH/NIAID/DEA, Room 3139, 6700B Rockledge Drive, MSC 7616, Bethesda, MD 20892, (301) 451–2592, pricebd@niaid.nih.gov. (Catalogue of Federal Domestic Assistance Program Nos. 93.855, Allergy, Immunology, and Transplantation Research; 93.856, Microbiology and Infectious Diseases Research, National Institutes of Health, HHS) Dated: January 14, 2010. Jennifer Spaeth, Director, Office of Federal Advisory Committee Policy. [FR Doc. 2010–1050 Filed 1–20–10; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Institute of Allergy and Infectious Diseases; Notice of Closed Meetings 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: Microbiology, Infectious Diseases and AIDS Initial Review Group; Microbiology and Infectious Diseases B Subcommittee. Date: February 11–12, 2010. Time: 8 a.m. to 6 p.m. Agenda: To review and evaluate grant applications. PO 00000 Frm 00031 Fmt 4703 Sfmt 4703 DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Institute of Diabetes and Digestive and Kidney Diseases; Notice of Closed Meetings 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: National Institute of Diabetes and Digestive and Kidney Diseases Special Emphasis Panel, NIDDK KUHFellowship Review. Date: February 19, 2010. Time: 8 a.m. to 5 p.m. E:\FR\FM\21JAN1.SGM 21JAN1

Agencies

[Federal Register Volume 75, Number 13 (Thursday, January 21, 2010)]
[Notices]
[Page 3472]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-1050]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


National Institute of Allergy and Infectious Diseases; Notice of 
Closed Meetings

    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: Microbiology, Infectious Diseases and AIDS 
Initial Review Group; Microbiology and Infectious Diseases B 
Subcommittee.
    Date: February 11-12, 2010.
    Time: 8 a.m. to 6 p.m.
    Agenda: To review and evaluate grant applications.
    Place: Holiday Inn Chevy Chase, 5520 Wisconsin Avenue, Chevy 
Chase, MD 20815.
    Contact Person: Gary S. Madonna, PhD, Scientific Review Officer, 
Scientific Review Program, Division of Extramural Activities, NIAID, 
National Institutes of Health, 6700B Rockledge Drive, MSC 7616, 
Bethesda, MD 20892, 301-496-3528, gm12w@nih.gov.

    Name of Committee: National Institute of Allergy and Infectious 
Diseases Special Emphasis Panel; NIAID Clinical Trial Planning (R34) 
Grants and Implementation (U01) Cooperative Agreements.
    Date: February 12, 2010.
    Time: 8 a.m. to 6 p.m.
    Agenda: To review and evaluate grant applications.
    Place: Crowne Plaza Hotel--Silver Spring, 8777 Georgia Avenue, 
Silver Spring, MD 20910.
    Contact Person: B. Duane Price, PhD, Scientific Review Officer, 
Scientific Review Program, HHS/NIH/NIAID/DEA, Room 3139, 6700B 
Rockledge Drive, MSC 7616, Bethesda, MD 20892, (301) 451-2592, 
pricebd@niaid.nih.gov.

(Catalogue of Federal Domestic Assistance Program Nos. 93.855, 
Allergy, Immunology, and Transplantation Research; 93.856, 
Microbiology and Infectious Diseases Research, National Institutes 
of Health, HHS)

    Dated: January 14, 2010.
Jennifer Spaeth,
Director, Office of Federal Advisory Committee Policy.
[FR Doc. 2010-1050 Filed 1-20-10; 8:45 am]
BILLING CODE 4140-01-P
This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.