Center for Scientific Review; Notice of Closed Meetings, 57114-57115 [2014-22660]

Download as PDF 57114 Federal Register / Vol. 79, No. 185 / Wednesday, September 24, 2014 / Notices Submit written requests for single copies of the guidance to the Communications Staff (HFV–12), Center for Veterinary Medicine, Food and Drug Administration, 7519 Standish Pl., Rockville, MD 20855. Send one selfaddressed adhesive label to assist that office in processing your request. See the SUPPLEMENTARY INFORMATION section for electronic access to the draft guidance document. Submit electronic comments on the draft guidance to http:// www.regulations.gov. Submit written comments to the Division of Dockets Management (HFA–305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. FOR FURTHER INFORMATION CONTACT: Marilyn Martinez, Center for Veterinary Medicine (HFV–100), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 240–402–0635, Marilyn.Martinez@fda.hhs.gov. SUPPLEMENTARY INFORMATION: asabaliauskas on DSK5VPTVN1PROD with NOTICES ADDRESSES: I. Background FDA is announcing the availability of a draft guidance for industry (GFI #224) entitled ‘‘Draft Guidance for Industry, Bioequivalence: Blood Level Bioequivalence Study’’ (VICH GL52). In recent years, many important initiatives have been undertaken by regulatory authorities and industry associations to promote the international harmonization of regulatory requirements. FDA has participated in efforts to enhance harmonization and has expressed its commitment to seek scientifically based harmonized technical procedures for the development of pharmaceutical products. One of the goals of harmonization is to identify and then reduce differences in technical requirements for drug development among regulatory agencies in different countries. FDA has actively participated in the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use for several years to develop harmonized technical requirements for the approval of human pharmaceutical and biological products among the European Union, Japan, and the United States. The VICH is a parallel initiative for veterinary medicinal products. The VICH is concerned with developing harmonized technical requirements for the approval of veterinary medicinal products in the European Union, Japan, and the United States, and includes input from both regulatory and industry representatives. The VICH Steering Committee is composed of member representatives VerDate Sep<11>2014 18:41 Sep 23, 2014 Jkt 232001 from the European Commission; European Medicines Evaluation Agency; European Federation of Animal Health; Committee on Veterinary Medicinal Products; FDA; U.S. Department of Agriculture; the Animal Health Institute; the Japanese Veterinary Pharmaceutical Association; the Japanese Association of Veterinary Biologics; and the Japanese Ministry of Agriculture, Forestry, and Fisheries. Six observers are eligible to participate in the VICH Steering Committee: One representative from the government of Australia/New Zealand, one representative from the industry in Australia/New Zealand, one representative from the government of Canada, one representative from the industry of Canada, one representative from the government of South Africa, and one representative from the industry of South Africa. The VICH Secretariat, which coordinates the preparation of documentation, is provided by the International Federation for Animal Health (IFAH). An IFAH representative also participates in the VICH Steering Committee meetings. II. Draft Guidance on Bioequivalence: Blood Level Bioequivalence Study The VICH Steering Committee held a meeting in November 2013 and agreed that the draft guidance document entitled ‘‘Draft Guidance for Industry, Bioequivalence: Blood Level Bioequivalence Study’’ (VICH GL52) should be made available for public comment. This draft VICH guidance document is intended to harmonize the data recommendations associated with in vivo blood level BE for veterinary pharmaceutical products. To meet this objective, the draft guidance addresses the following topics: A harmonized definition of BE, factors/variables that should be considered when developing scientifically sound blood level BE study designs, and information that should be included in a blood level BE study report. FDA and the VICH Expert Working Group will consider comments about the draft guidance document. III. Significance of Guidance This draft guidance, developed under the VICH process, has been revised to conform to FDA’s good guidance practices regulation (21 CFR 10.115). For example, the document has been designated ‘‘guidance’’ rather than ‘‘guideline.’’ In addition, guidance documents must not include mandatory language such as ‘‘shall,’’ ‘‘must,’’ ‘‘require,’’ or ‘‘requirement,’’ unless PO 00000 Frm 00071 Fmt 4703 Sfmt 4703 FDA is using these words to describe a statutory or regulatory requirement. The draft guidance, when finalized, will represent 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 applicable statutes and regulations. IV. Paperwork Reduction Act of 1995 This draft guidance refers to previously approved collections of information found in FDA regulations. These collections of information are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Action of 1995 (44 U.S.C. 3501–3520). The collections of information in this draft guidance have been approved under OMB control numbers 0910–0032 and 0910–0669. V. Comments Interested persons may submit either electronic comments regarding this document to http://www.regulations.gov or written comments to the Division of Dockets Management (see ADDRESSES). It is only necessary to send one set of 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, and will be posted to the docket at http:// www.regulations.gov. VI. Electronic Access Persons with access to the Internet may obtain the draft guidance at either http://www.fda.gov/AnimalVeterinary/ GuidanceComplianceEnforcement/ GuidanceforIndustry/default.htm or http://www.regulations.gov. Dated: September 18, 2014. Leslie Kux, Assistant Commissioner for Policy. [FR Doc. 2014–22681 Filed 9–23–14; 8:45 am] BILLING CODE 4164–01–P 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. App.), notice is hereby given of the following meetings. E:\FR\FM\24SEN1.SGM 24SEN1 Federal Register / Vol. 79, No. 185 / Wednesday, September 24, 2014 / Notices asabaliauskas on DSK5VPTVN1PROD with NOTICES 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 PAR 13–213: Outcome Measures for Use in Treatment Trials for Individuals with Intellectual and Developmental Disabilities (R01). Date: October 8, 2014. Time: 1:30 p.m. to 3:00 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: Jane A. DoussardRoosevelt, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 3184, MSC 7848, Bethesda, MD 20892, (301) 435–4445, doussarj@csr.nih.gov. Name of Committee: Immunology Integrated Review Group, Innate Immunity and Inflammation Study Section. Date: October 21–22, 2014. Time: 8:00 a.m. to 6:00 p.m. Agenda: To review and evaluate grant applications. Place: Salt Lake Marriott Downtown at City Creek, 75 South West Temple, Salt Lake, UT 84101. Contact Person: Tina McIntyre, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 4202, MSC 7812, Bethesda, MD 20892, 301–594– 6375, mcintyrt@csr.nih.gov. Name of Committee: Biological Chemistry and Macromolecular Biophysics Integrated Review Group, Macromolecular Structure and Function A Study Section. Date: October 21–22, 2014. Time: 8:30 a.m. to 5:00 p.m. Agenda: To review and evaluate grant applications. Place: Renaissance Washington, DC Hotel, 999 Ninth Street NW., Washington, DC 20001–4427. Contact Person: Nitsa Rosenzweig, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 4152, MSC 7760, Bethesda, MD 20892, (301) 404– 7419, rosenzweign@csr.nih.gov. Name of Committee: Center for Scientific Review Special Emphasis Panel Macromolecular Structure and Function. Date: October 21, 2014. Time: 1:00 p.m. to 2:00 p.m. Agenda: To review and evaluate grant applications. Place: Renaissance Washington, DC Hotel, 999 Ninth Street NW., Washington, DC 20001–4427. VerDate Sep<11>2014 18:41 Sep 23, 2014 Jkt 232001 Contact Person: James W. Mack, Ph.D., Scientific Review Administrator, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 4154, MSC 7806, Bethesda, MD 20892, (301) 435– 2037, mackj2@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: September 17, 2014. David Clary, Program Analyst, Office of Federal Advisory Committee Policy. [FR Doc. 2014–22660 Filed 9–23–14; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Heart, Lung, and Blood Institute; Notice of Meeting Pursuant to section 10(a) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of a meeting of the Sickle Cell Disease Advisory Committee. The meeting will be open to the public, 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. Name of Committee: Sickle Cell Disease Advisory Committee. Date: October 17, 2014, Time: 8:00 a.m. to 5:00 p.m., Agenda: Discussion of Programs. Place: National Institutes of Health, 6701 Rockledge Drive, Room 9100/9104, Bethesda, MD 20892. Contact Person: W. Keith Hoots, MD, Director, Division of Blood Diseases and Resources, National Heart, Lung, and Blood Institute, 6701 Rockledge Drive, Suite 9030, Bethesda, MD 20892, 301–435–0080, hootswk@nhlbi.nih.gov. Information is also available on the Institute’s/Center’s home page: www.nhlbi.nih.gov/meetings/index.htm, where an agenda and any additional information for the meeting will be posted when available. (Catalogue of Federal Domestic Assistance Program Nos. 93.233, National Center for Sleep Disorders Research; 93.837, Heart and Vascular Diseases Research; 93.838, Lung Diseases Research; 93.839, Blood Diseases and Resources Research, National Institutes of Health, HHS) PO 00000 Frm 00072 Fmt 4703 Sfmt 4703 57115 Dated: September 17, 2014. Michelle Trout, Program Analyst, Office of Federal Advisory Committee Policy. [FR Doc. 2014–22655 Filed 9–23–14; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Heart, Lung, and Blood Institute; 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 Heart, Lung, and Blood Advisory Council. 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 Heart, Lung, and Blood Advisory Council. Date: October 22, 2014. Open: 8:00 a.m. to 1:00 p.m. Agenda: To discuss program policies and issues. Place: National Institutes of Health, Building 31, Room 10, 31 Center Drive, Bethesda, MD 20892. Closed: 1:00 p.m. to 5:00 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, Building 31, Room 10, 31 Center Drive, Bethesda, MD 20892. Contact Person: Stephen C. Mockrin, Ph.D., Director, Division of Extramural Research Activities, National Heart, Lung, and Blood Institute, National Institutes of Health, 6701 Rockledge Drive, Room 7100, Bethesda, MD 20892, (301) 435–0260, mockrins@ nhlbi.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 E:\FR\FM\24SEN1.SGM 24SEN1

Agencies

[Federal Register Volume 79, Number 185 (Wednesday, September 24, 2014)]
[Notices]
[Pages 57114-57115]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-22660]


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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. App.), notice is hereby given of the following 
meetings.

[[Page 57115]]

    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 PAR 13-213: Outcome Measures for Use in Treatment Trials for 
Individuals with Intellectual and Developmental Disabilities (R01).
    Date: October 8, 2014.
    Time: 1:30 p.m. to 3:00 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: Jane A. Doussard-Roosevelt, Ph.D., Scientific 
Review Officer, Center for Scientific Review, National Institutes of 
Health, 6701 Rockledge Drive, Room 3184, MSC 7848, Bethesda, MD 
20892, (301) 435-4445, doussarj@csr.nih.gov.

    Name of Committee: Immunology Integrated Review Group, Innate 
Immunity and Inflammation Study Section.
    Date: October 21-22, 2014.
    Time: 8:00 a.m. to 6:00 p.m.
    Agenda: To review and evaluate grant applications.
    Place: Salt Lake Marriott Downtown at City Creek, 75 South West 
Temple, Salt Lake, UT 84101.
    Contact Person: Tina McIntyre, Ph.D., Scientific Review Officer, 
Center for Scientific Review, National Institutes of Health, 6701 
Rockledge Drive, Room 4202, MSC 7812, Bethesda, MD 20892, 301-594-
6375, mcintyrt@csr.nih.gov.

    Name of Committee: Biological Chemistry and Macromolecular 
Biophysics Integrated Review Group, Macromolecular Structure and 
Function A Study Section.
    Date: October 21-22, 2014.
    Time: 8:30 a.m. to 5:00 p.m.
    Agenda: To review and evaluate grant applications.
    Place: Renaissance Washington, DC Hotel, 999 Ninth Street NW., 
Washington, DC 20001-4427.
    Contact Person: Nitsa Rosenzweig, Ph.D., Scientific Review 
Officer, Center for Scientific Review, National Institutes of 
Health, 6701 Rockledge Drive, Room 4152, MSC 7760, Bethesda, MD 
20892, (301) 404-7419, rosenzweign@csr.nih.gov.

    Name of Committee: Center for Scientific Review Special Emphasis 
Panel Macromolecular Structure and Function.
    Date: October 21, 2014.
    Time: 1:00 p.m. to 2:00 p.m.
    Agenda: To review and evaluate grant applications.
    Place: Renaissance Washington, DC Hotel, 999 Ninth Street NW., 
Washington, DC 20001-4427.
    Contact Person: James W. Mack, Ph.D., Scientific Review 
Administrator, Center for Scientific Review, National Institutes of 
Health, 6701 Rockledge Drive, Room 4154, MSC 7806, Bethesda, MD 
20892, (301) 435-2037, mackj2@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: September 17, 2014.
David Clary,
Program Analyst, Office of Federal Advisory Committee Policy.
[FR Doc. 2014-22660 Filed 9-23-14; 8:45 am]
BILLING CODE 4140-01-P