National Institute of Diabetes and Digestive and Kidney Diseases; Notice of Closed Meeting, 61782-61783 [06-8772]

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 In the Federal Register of August 13, 2001 (66 FR 42547), FDA announced the availability of the draft guidance of the same title. FDA received several comments on the draft guidance and those comments were considered as the guidance was finalized.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 The guidance announced in this notice finalizes the draft guidance dated August 2001.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 Federal Register / Vol. 71, No. 202 / Thursday, October 19, 2006 / Notices Dated: October 10, 2006. Linda Payne, Acting Director, Office of Federal Advisory Committee Policy. [FR Doc. 06–8772 Filed 10–18–06; 8:45 am] BILLING CODE 4140–01–M DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Institute of Neurological Disorders and Stroke; Notice of Closed Meetings cprice-sewell on PROD1PC66 with NOTICES 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 meetings. 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 Neurological Disorders and Stroke Special Emphasis Panel, Glioma Therapies SEP. Date: November 3, 2006. Time: 11 a.m. to 1 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, Neuroscience Center, 6001 Executive Boulevard, Rockville, MD 20852 (Telephone Conference Call). Contact Person: Shantadurga Rajaram, PhD, Scientific Review Administrator, Scientific Review Branch, NIH/NINDS/ Neuroscience Center, 6001 Executive Blvd., Suite 3208, MSC 9529, Bethesda, MD 20852, 301–435–6033, rajarams@mail.nih.gov. Name of Committee: National Institute of Neurological Disorders and Stroke Special Emphasis Panel, Epilepsy Studies SEP. Date: November 6, 2006. Time: 2:30 p.m. to 4:30 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, Neuroscience Center, 6001 Executive Boulevard, Rockville, MD 20852 (Telephone Conference Call). Contact Person: Shantadurga Rajaram, PhD, Scientific Review Administrator, Scientific Review Branch, NIH/NINDS/ Neuroscience Center, 6001 Executive Blvd., Suite 3208, MSC 9529, Bethesda, MD 20852, 301–435–6033, rajarams@mail.nih.gov. Name of Committee: National Institute of Neurological Disorders and Stroke Special Emphasis Panel, K99/R00 REVIEW. VerDate Aug<31>2005 14:50 Oct 18, 2006 Jkt 211001 Date: November 15, 2006. Time: 8 a.m. to 5 p.m. Agenda: To review and evaluate grant applications. Place: The Fairmont Washington, DC., 2401 M Street, NW., Washington, DC 20037. Contact Person: JoAnn McConnell, PhD, Scientific Review Administrator, Scientific Review Branch, NIH/NINDS/Neuroscience Center, 6001 Executive Blvd., Suite 3208, MSC 9529, Bethesda, MD 20892–9529, 301– 496–5324, mcconnej@ninds.nih.gov. Name of Committee: National Institute of Neurological Disorders and Stroke Special Emphasis Panel, NINDS Roadmap HTS Assay Development. Date: November 16–17, 2006. Time: 8 a.m. to 6 p.m. Agenda: To review and evaluate grant applications. Place: The Watergate Hotel, 2650 Virginia Ave., NW., Monticello, Washington, DC 20037. Contact Person: Shantadurga Rajaram, PhD, Scientific Review Administrator, Scientific Review Branch, NIH/NINDS/ Neuroscience Center, 6001 Executive Blvd., Suite 3208, MSC 9529, Bethesda, MD 20852, 301–435–6033, rajarams@mail.nih.gov. Name of Committee: National Institute of Neurological Disorders and Stroke Special Emphasis Panel, Fellowship Review. Date: November 17, 2006. Time: 8 a.m. to 5 p.m. Agenda: To review and evaluate grant applications. Place: Topaz Hotel, 1733 N Street, NW., Washington, DC 20036. Contact Person: JoAnn McConnell, PhD, Scientific Review Administrator, Scientific Review Branch, NIH/NINDS/Neuroscience Center, 6001 Executive Blvd., Suite 3208, MSC 9529, Bethesda, MD 20892–9529, 301– 496–5324, mcconnell@ninds.nih.gov. Name of Committee: National Institute of Neurological Disorders and Stroke Special Emphasis Panel, Mechanisms of Epilepsy. Date: November 28, 2006. Time: 1 p.m. to 5 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, Neuroscience Center, 6001 Executive Boulevard, Rockville, MD 20852 (Telephone Conference Call). Contact Person: Shantadurga Rajaram, PhD, Scientific Review Administrator, Scientific Review Branch, NIH/NINDS/ Neuroscience Center, 6001 Executive Blvd., Suite 3208, MSC 9529, Bethesda, MD 20852, 301–435–6033, rajarams@mail.nih.gov. (Catalogue of Federal Domestic Assistance Program Nos. 93.853, Clinical Research Related to Neurological Disorders; 93.854, Biological Basis Research in the Neurosciences, National Institutes of Health, HHS) Dated: October 10, 2006. Linda Payne, Acting Director, Office of Federal Advisory Committee Policy. [FR Doc. 06–8773 Filed 10–18–06; 8:45 am] BILLING CODE 4140–01–M PO 00000 Frm 00078 Fmt 4703 Sfmt 4703 61783 DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Institute of Child Health and Human Development; Notice of Closed Meetings 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 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 Child Health and Human Development Special Emphasis Panel, Mechanisms of Preeclampsia; Impact of Obesity. Date: October 25, 2006. Time: 1 p.m. to 4 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, 6100 Executive Boulevard, Room 5B01, Rockville, MD 20852 (Telephone Conference Call). Contact Person: Gopal M. Bhatnagar, PhD, Scientific Review Administrator, National Institutes of Health, 6100 Bldg Rm 5B01, Rockville, MD 20852, 301–435–6889. bhatnagg@mail.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. Name of Committee: National Institute of Child Health and Human Development Special Emphasis Panel, Health, Behavior, and Context Subcommittee. Date: October 26–27, 2006. Time: 8 a.m. to 5 p.m. Agenda: To review and evaluate grant applications. Place: Bethesda Marriott Suites, 6711 Democracy Boulevard, Bethesda, MD 20817. Contact Person: Michele C. HindiAlexander, PhD, Division of Scientific Review, National Institutes of Health, National Institute for Child Health, and Human Development, 6100 Executive Boulevard, Room 5B01, Bethesda, MD 20812–7510, 301–435–8382. hindialm@mail.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. 93.864, Population Research; E:\FR\FM\19OCN1.SGM 19OCN1

Agencies

[Federal Register Volume 71, Number 202 (Thursday, October 19, 2006)]
[Notices]
[Pages 61782-61783]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 06-8772]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


National Institute of Diabetes and Digestive and Kidney Diseases; 
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 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)



[[Page 61783]]


    Dated: October 10, 2006.
Linda Payne,
Acting Director, Office of Federal Advisory Committee Policy.
[FR Doc. 06-8772 Filed 10-18-06; 8:45 am]
BILLING CODE 4140-01-M

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