Office of the Director, National Institutes of Health; Amended Notice of Meeting, 66367 [2013-26414]

Download as PDF Federal Register / Vol. 78, No. 214 / Tuesday, November 5, 2013 / Notices wreier-aviles on DSK5TPTVN1PROD with NOTICES updated recommendations concerning donor testing for evidence of T. pallidum infection. HCT/P Establishments must, as required under § 1271.80(a) and (c) (21 CFR 1271.80(a) and (c)), test a donor specimen for evidence of infection due to T. pallidum using appropriate FDA-licensed, approved, or cleared donor screening tests, in accordance with the manufacturer’s instructions, unless an exception to this requirement applies under 21 CFR 1271.90. The draft guidance clarifies that FDA does not consider diagnostic tests or preamendment devices (which have not been licensed, approved, or cleared) to be adequate for use in donor testing for T. pallidum infection under the criteria specified in § 1271.80(c). FDA will no longer exercise enforcement discretion that permits the use of diagnostic syphilis tests or pre-amendments devices for use as an HCT/P donor screening test because the wide availability of FDA-licensed, approved, or cleared test systems with an indication for use in donor screening no longer supports such enforcement discretion. In the Federal Register of February 28, 2007 (72 FR 9007), FDA announced the availability of the guidance entitled ‘‘Guidance for Industry: Eligibility Determination for Donors of Human Cells, Tissues, and Cellular and TissueBased Products (HCT/Ps),’’ dated February 2007. FDA issued a revised version of this guidance under the same title, dated August 2007 (hereafter referred to as the 2007 Donor Eligibility guidance). The draft guidance announced in this notice, when finalized, will supersede the recommendations for testing HCT/P donors for T. pallidum that were contained in the 2007 Donor Eligibility guidance. The draft guidance is being issued consistent with FDA’s good guidance practices regulation (21 CFR 10.115). The draft guidance, when finalized, will represent FDA’s current thinking on this topic.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 requirement of the applicable statutes and regulations. II. Comments The draft guidance is being distributed for comment purposes only and is not intended for implementation at this time. Interested persons may submit either electronic comments regarding this document to https:// www.regulations.gov or written VerDate Mar<15>2010 15:22 Nov 04, 2013 Jkt 232001 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 https:// www.regulations.gov. III. Electronic Access Persons with access to the Internet may obtain the draft guidance at either https://www.fda.gov/BiologicsBlood Vaccines/GuidanceCompliance RegulatoryInformation/Guidances/ default.htm or https:// www.regulations.gov. Dated: October 30, 2013. Leslie Kux, Assistant Commissioner for Policy. [FR Doc. 2013–26397 Filed 11–4–13; 8:45 am] BILLING CODE 4160–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health 66367 Name of Committee: National Institute of General Medical Sciences Initial Review Group; Training and Workforce Development Subcommittee—B. Date: November 22, 2013. Time: 8:00 a.m. to 5:00 p.m. Agenda: To review and evaluate grant applications. Place: Hyatt Regency Bethesda, 7400 Wisconsin Avenue, Bethesda, MD 20814. Contact Person: Arthur L. Zachary, Ph.D., Scientific Review Officer, Office of Scientific Review, National Institute of General Medical Sciences, National Institutes of Health, 45 Center Drive, Room 3An.12, Bethesda, MD 20892–4874, 301–594–2886, zacharya@ nigms.nih.gov. (Catalogue of Federal Domestic Assistance Program Nos. 93.375, Minority Biomedical Research Support; 93.821, Cell Biology and Biophysics Research; 93.859, Pharmacology, Physiology, and Biological Chemistry Research; 93.862, Genetics and Developmental Biology Research; 93.88, Minority Access to Research Careers; 93.96, Special Minority Initiatives, National Institutes of Health, HHS) Dated: October 30, 2013. Melanie J. Gray, Program Analyst, Office of Federal Advisory Committee Policy. [FR Doc. 2013–26435 Filed 11–4–13; 8:45 am] National Institute of General Medical Sciences; 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 General Medical Sciences Initial Review Group; Training and Workforce Development Subcommittee—A. Date: November 21, 2013. Time: 8:00 a.m. to 5:00 p.m. Agenda: To review and evaluate grant applications. Place: Courtyard by Marriott, 5520 Wisconsin Avenue, Chevy Chase, MD 20815. Contact Person: John J. Laffan, Ph.D., Scientific Review Officer, Office of Scientific Review, National Institute of General Medical Sciences, National Institutes of Health, 45 Center Drive, Room 3An.18J, Bethesda, MD 20892–4874, 301–594–2773, laffanjo@ mail.nih.gov. PO 00000 Frm 00039 Fmt 4703 Sfmt 9990 BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Office of the Director, National Institutes of Health; Amended Notice of Meeting Notice is hereby given of a change in the meeting of the Office of Research Infrastructure Programs Special Emphasis Panel, October 15, 2013, 08:00 a.m. to October 15, 2013, 05:30 p.m., National Institutes of Health, One Democracy Plaza, 6701 Democracy Boulevard, Bethesda, MD, 20892, which was published in the Federal Register on September 16, 2013, 78 FR 56903. The meeting date is changed from October 15, 2013 to November 14, 2013. The meeting is closed to the public. Dated: October 30, 2013. David Clary, Program Analyst, Office of Federal Advisory Committee Policy. [FR Doc. 2013–26414 Filed 11–4–13; 8:45 am] BILLING CODE 4140–01–P E:\FR\FM\05NON1.SGM 05NON1

Agencies

[Federal Register Volume 78, Number 214 (Tuesday, November 5, 2013)]
[Notices]
[Page 66367]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-26414]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Office of the Director, National Institutes of Health; Amended 
Notice of Meeting

    Notice is hereby given of a change in the meeting of the Office of 
Research Infrastructure Programs Special Emphasis Panel, October 15, 
2013, 08:00 a.m. to October 15, 2013, 05:30 p.m., National Institutes 
of Health, One Democracy Plaza, 6701 Democracy Boulevard, Bethesda, MD, 
20892, which was published in the Federal Register on September 16, 
2013, 78 FR 56903.
    The meeting date is changed from October 15, 2013 to November 14, 
2013. The meeting is closed to the public.

    Dated: October 30, 2013.
David Clary,
Program Analyst, Office of Federal Advisory Committee Policy.
[FR Doc. 2013-26414 Filed 11-4-13; 8:45 am]
BILLING CODE 4140-01-P
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