National Institute of Allergy and Infectious Diseases; Notice of Closed Meetings, 18510-18511 [2010-8038]

Download as PDF 18510 Federal Register / Vol. 75, No. 69 / Monday, April 12, 2010 / Notices Recommendation of Pharmacopoeial Texts for Use in the ICH Regions.’’ DATES: Submit written or electronic comments on agency guidances at any time. Submit written requests for single copies of the guidance to the Division of Drug Information (HFD– 240), Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, rm. 2201, Silver Spring, MD 20993–0002; or the Office of Communication, Outreach and Development (HFM–40), Center for Biologics Evaluation and Research (CBER), Food and Drug Administration, 1401 Rockville Pike, suite 200N, Rockville, MD 20852–1448. The guidance may also be obtained by mail by calling CBER at 1–800–835–4709 or 301–827–1800. Send two self-addressed adhesive labels to assist the office in processing your requests. Submit written comments on the guidance 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. See the SUPPLEMENTARY INFORMATION section for electronic access to the guidance document. ADDRESSES: FOR FURTHER INFORMATION CONTACT: Regarding the guidance: Robert H. King, Sr., Center for Drug Evaluation and Research (HFD– 003), Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, rm. 4150, Silver Spring, MD 20993–0002, 301–796–1242; or Christopher Joneckis, Center for Biologics Evaluation and Research (HFM–25), Food and Drug Administration, 1401 Rockville Pike, suite 200N, Rockville, MD 20852–1448, 301–827–0373. Regarding the ICH: Michelle Limoli, Office of International Programs (HFG–1), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301–827– 4480. SUPPLEMENTARY INFORMATION: sroberts on DSKD5P82C1PROD with NOTICES I. Background In recent years, many important initiatives have been undertaken by regulatory authorities and industry associations to promote international harmonization of regulatory requirements. FDA has participated in many meetings designed to enhance harmonization and is committed to seeking scientifically based harmonized VerDate Nov<24>2008 17:58 Apr 09, 2010 Jkt 220001 technical procedures for pharmaceutical development. One of the goals of harmonization is to identify and then reduce differences in technical requirements for drug development among regulatory agencies. ICH was organized to provide an opportunity for tripartite harmonization initiatives to be developed with input from both regulatory and industry representatives. FDA also seeks input from consumer representatives and others. ICH is concerned with harmonization of technical requirements for the registration of pharmaceutical products among three 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 August 14, 2009 (74 FR 41143), FDA published a notice announcing the availability of a draft tripartite guidance entitled ‘‘Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions; Annex 10: Polyacrylamide Gel Electrophoresis General Chapter.’’ The notice gave interested persons an opportunity to submit comments by October 13, 2009. After consideration of the comments received and revisions to the guidance, a final draft guidance entitled ‘‘Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions; Annex 10: Polyacrylamide Gel Electrophoresis General Chapter’’ was submitted to the ICH Steering Committee and endorsed by the three participating regulatory agencies in October 2009. The guidance provides the specific evaluation outcome from the ICH Q4B process for the Polyacrylamide Gel Electrophoresis General Chapter harmonization proposal originating from the three-party PDG. This guidance is in the form of an annex to the core PO 00000 Frm 00042 Fmt 4703 Sfmt 4703 ICH Q4B guidance. When implemented, the annex will provide guidance for industry and regulators on the use of the specific pharmacopoeial texts evaluated by the ICH Q4B process. Following receipt of comments on the draft, no substantive changes were made to the annex. 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. 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. 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: April 6, 2010. Leslie Kux, Acting Assistant Commissioner for Policy. [FR Doc. 2010–8227 Filed 4–9–10; 8:45 am] BILLING CODE 4160–01–S 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 E:\FR\FM\12APN1.SGM 12APN1 Federal Register / Vol. 75, No. 69 / Monday, April 12, 2010 / Notices sroberts on DSKD5P82C1PROD with NOTICES 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 Allergy and Infectious Diseases Special Emphasis Panel; ‘‘In Vitro Assessments for Antimicrobial Activity—Viruses’’. Date: May 3, 2010. Time: 8 a.m. to 6 p.m. Agenda: To review and evaluate contract proposals. Place: Hilton Silver Spring, 8727 Colesville Road, Silver Spring, MD 20910. Contact Person: Yong Gao, PhD, Scientific Review Officer, Scientific Review Program, DEA/NIAID/N IH/DHHS, Room 3246, 6700B Rockledge Drive, Bethesda, MD 20892–7616, 301–443–8115, gaol2@niaid.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: May 5, 2010. Time: 9 a.m. to 5 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, 6700 B Rockledge Drive, Bethesda, MD 20817 (Telephone Conference Call). Contact Person: B. Duane Price, PhD, Scientific Review Officer, Scientific Review Program, DHHS/NIH/NIAID, 6700B Rockledge Drive, MSC 7616, Room 3139, Bethesda, MD 20892, 301–451–2592, pricebd@niaid.nih.gov. Name of Committee: National Institute of Allergy and Infectious Diseases Special Emphasis Panel; ‘‘In vitro Assessments for Antimicrobial Activity—Toxins’’. Date: May 11, 2010. Time: 8 a.m. to 6 p.m. Agenda: To review and evaluate contract proposals. Place: National Institutes of Health, 6700B Rockledge Drive, Bethesda, MD 20817. Contact Person: Yong Gao, PhD, Scientific Review Officer, Scientific Review Program, DEA/NIAID/NIH/DHHS, Room 3246, 6700B Rockledge Drive, Bethesda, MD 20892–7616, 301–443–8115, gaol2@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: April 2, 2010. Anna Snouffer, Acting Director, Office of Federal Advisory Committee Policy. [FR Doc. 2010–8038 Filed 4–9–10; 8:45 am] BILLING CODE 4140–01–M VerDate Nov<24>2008 17:58 Apr 09, 2010 Jkt 220001 DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Institute on Aging; 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 Aging. 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 Aging. Date: May 25–26, 2010. Closed: May 25, 2010, 3 p.m. to 5 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, Building 31, 31 Center Drive, C Wing, Conference Room 10, Bethesda, MD 20892. Open: May 26, 2010, 8 a.m. to 1 p.m. Agenda: Call to order and reports from the Task Force on Minority Aging Research, the Working Group on Program; Division of Geriatrics and Clinical Gerontology Review; and Program Highlights. Place: National Institutes of Health, Building 31, 31 Center Drive, C Wing, Conference Room 10, Bethesda, MD 20892. Contact Person: Robin Barr, Ph.D., Director, National Institute On Aging, Office of Extramural Activities, Gateway Building, 7201 Wisconsin Avenue, Bethesda, MD 20814. (301) 496–9322. barrr@nia.nih.gov. 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, PO 00000 Frm 00043 Fmt 4703 Sfmt 4703 18511 or passport) and to state the purpose of their visit. Information is also available on the Institute’s/Center’s home page: https:// www.nih.gov/nia/naca/, where an agenda and any additional information for the meeting will be posted when available. (Catalogue of Federal Domestic Assistance Program Nos. 93.866, Aging Research, National Institutes of Health, HHS) Dated: April 7, 2010. Jennifer Spaeth, Director, Office of Federal Advisory Committee Policy. [FR Doc. 2010–8245 Filed 4–9–10; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Institute on Aging; 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 Aging Special Emphasis Panel, Loan Repayment. Date: May 3, 2010. Time: 12 p.m. to 4 p.m. Agenda: To review and evaluate grant applications. Place: National Institute on Aging. Gateway Building. 7201 Wisconsin Avenue, Suite 2C212. Bethesda, MD 20892. (Virtual Meeting). Contact Person: Bita Nakhai, PhD, Scientific Review Officer, Scientific Review Branch, National Institute on Aging, Gateway Bldg., 2C212, 7201 Wisconsin Avenue, Bethesda, MD 20814, 301–402–7701, nakhaib@nia.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. (Catalogue of Federal Domestic Assistance Program Nos. 93.866, Aging Research, National Institutes of Health, HHS) E:\FR\FM\12APN1.SGM 12APN1

Agencies

[Federal Register Volume 75, Number 69 (Monday, April 12, 2010)]
[Notices]
[Pages 18510-18511]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-8038]


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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

[[Page 18511]]

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 Allergy and Infectious 
Diseases Special Emphasis Panel; ``In Vitro Assessments for 
Antimicrobial Activity--Viruses''.
    Date: May 3, 2010.
    Time: 8 a.m. to 6 p.m.
    Agenda: To review and evaluate contract proposals.
    Place: Hilton Silver Spring, 8727 Colesville Road, Silver 
Spring, MD 20910.
    Contact Person: Yong Gao, PhD, Scientific Review Officer, 
Scientific Review Program, DEA/NIAID/N IH/DHHS, Room 3246, 6700B 
Rockledge Drive, Bethesda, MD 20892-7616, 301-443-8115, 
gaol2@niaid.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: May 5, 2010.
    Time: 9 a.m. to 5 p.m.
    Agenda: To review and evaluate grant applications.
    Place: National Institutes of Health, 6700 B Rockledge Drive, 
Bethesda, MD 20817 (Telephone Conference Call).
    Contact Person: B. Duane Price, PhD, Scientific Review Officer, 
Scientific Review Program, DHHS/NIH/NIAID, 6700B Rockledge Drive, 
MSC 7616, Room 3139, Bethesda, MD 20892, 301-451-2592, 
pricebd@niaid.nih.gov.

    Name of Committee: National Institute of Allergy and Infectious 
Diseases Special Emphasis Panel; ``In vitro Assessments for 
Antimicrobial Activity--Toxins''.
    Date: May 11, 2010.
    Time: 8 a.m. to 6 p.m.
    Agenda: To review and evaluate contract proposals.
    Place: National Institutes of Health, 6700B Rockledge Drive, 
Bethesda, MD 20817.
    Contact Person: Yong Gao, PhD, Scientific Review Officer, 
Scientific Review Program, DEA/NIAID/NIH/DHHS, Room 3246, 6700B 
Rockledge Drive, Bethesda, MD 20892-7616, 301-443-8115, 
gaol2@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: April 2, 2010.
Anna Snouffer,
Acting Director, Office of Federal Advisory Committee Policy.
[FR Doc. 2010-8038 Filed 4-9-10; 8:45 am]
BILLING CODE 4140-01-M

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