National Human Genome Research Institute; Notice of Closed Meeting, 61782 [06-8777]

Download as PDF 61782 Federal Register / Vol. 71, No. 202 / Thursday, October 19, 2006 / Notices cprice-sewell on PROD1PC66 with NOTICES manufacturer must report either electronically or by mail using Form FDA–3486, a standardized reporting format. Examples of reportable and nonreportable events concerning the incoming material specifications, process controls, product specifications, product testing, product labeling, quality control procedures, and product distribution are discussed. These examples may not apply to all establishments because they include deviations and unexpected events related to standard operating procedures implemented at individual establishments and may not be an industry standard or a procedure at your facility. The guidance also contains a Biological Product Deviation Reporting Flowchart to aid in determining if an event is reportable. In the Federal Register of August 13, 2001 (66 FR 42547), FDA announced the availability of the draft guidance of the same title. FDA received several comments on the draft guidance and those comments were considered as the guidance was finalized. Editorial changes were made to improve clarity. The guidance announced in this notice finalizes the draft guidance dated August 2001. This guidance is being issued consistent with FDA’s good guidance practices regulation (21 CFR 10.115). This guidance represents the 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. Paperwork Reduction Act of 1995 This 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 Act of 1995 (44 U.S.C. 3501– 3520). The collection of information under § 600.14 was approved under OMB control number 0910–0458. The collections of information under 21 CFR 606.100 and 606.171 were approved under OMB control number 0910–0116. The collections of information under 21 CFR 820.90 and 820.100 were approved under OMB control number 0910–0139, and the collections of information under 21 CFR 211.192 and 211.198 were approved under OMB control number 0910–0073. III. Comments Interested persons may, at any time, submit written or electronic comments VerDate Aug<31>2005 14:50 Oct 18, 2006 Jkt 211001 to the Division of Dockets Management (see ADDRESSES) regarding this 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 the brackets in the heading of this document. A copy of the guidance and received comments are available for public examination in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday. (Catalogue of Federal Domestic Assistance Program Nos. 93.172, Human Genome Research, National Institutes of Health, HHS) IV. Electronic Access National Institutes of Health Persons with access to the Internet may obtain the guidance at either https:// www.fda.gov/cber/guidelines.htm or https://www.fda.gov/ohrms/dockets/ default.htm. National Institute of Diabetes and Digestive and Kidney Diseases; Notice of Closed Meeting Dated: October 10, 2006. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. E6–17374 Filed 10–18–06; 8:45 am] BILLING CODE 4160–01–S DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Human Genome Research Institute; Notice of Closed Meeting 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 meeting. The meeting will be closed to the public in accordance with the provisions set forth in section 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 Human Genome Research Institute Special Emphasis Panel, Resources and Training Review Teleconference. Date: November 8, 2006. Time: 8 a.m. to 5 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, 5635 Fishers Lane, Bethesda, MD 20892. Contact Person: Keith McKenney, PhD, Scientific Review Administrator, NHGRI, 5635 Fishers Lane, Suite 4076, Bethesda, MD 20814. 301–594–4280, mckenneyk@mail.nih.gov. PO 00000 Frm 00077 Fmt 4703 Sfmt 4703 Dated: October 10, 2006. Linda Payne, Acting Director, Office of Federal Advisory Committee Policy. [FR Doc. 06–8777 Filed 10–18–06; 8:45 am] BILLING CODE 4140–01–M DEPARTMENT OF HEALTH AND HUMAN SERVICES 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 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 of Diabetes and Digestive and Kidney Diseases Special Emphasis Panel, Conference Grants Review. Date: October 20, 2006. Time: 1 p.m. to 3 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, Two Democracy Plaza, 6707 Democracy Boulevard, Bethesda, MD 20892, (Telephone Conference Call). Contact Person: Atul Sahai, PhD, Scientific Review Administrator, Review Branch, DEA, NIDDK, National Institutes of Health, Room 908, 6707 Democracy Boulevard, Bethesda, MD 20892–5452, 301–594–2242, sahaia@niddk.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. 93.847, Diabetes, Endocrinology and Metabolic Research; 93.848, Digestive Diseases and Nutrition Research; 93.849, Kidney Diseases, Urology and Hematology Research, National Institutes of Health, HHS) E:\FR\FM\19OCN1.SGM 19OCN1

Agencies

[Federal Register Volume 71, Number 202 (Thursday, October 19, 2006)]
[Notices]
[Page 61782]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 06-8777]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


National Human Genome Research Institute; Notice of Closed 
Meeting

    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 
meeting.
    The meeting will be closed to the public in accordance with the 
provisions set forth in section 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 Human Genome Research Institute 
Special Emphasis Panel, Resources and Training Review 
Teleconference.
    Date: November 8, 2006.
    Time: 8 a.m. to 5 p.m.
    Agenda: To review and evaluate grant applications.
    Place: National Institutes of Health, 5635 Fishers Lane, 
Bethesda, MD 20892.
    Contact Person: Keith McKenney, PhD, Scientific Review 
Administrator, NHGRI, 5635 Fishers Lane, Suite 4076, Bethesda, MD 
20814. 301-594-4280, mckenneyk@mail.nih.gov.

(Catalogue of Federal Domestic Assistance Program Nos. 93.172, Human 
Genome Research, National Institutes of Health, HHS)

    Dated: October 10, 2006.
Linda Payne,
Acting Director, Office of Federal Advisory Committee Policy.
[FR Doc. 06-8777 Filed 10-18-06; 8:45 am]
BILLING CODE 4140-01-M

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