National Institute of Diabetes and Digestive and Kidney Diseases: Notice of Closed Meetings, 84598-84599 [2016-28148]

Download as PDF 84598 Federal Register / Vol. 81, No. 226 / Wednesday, November 23, 2016 / Notices This guidance replaces the draft guidance of the same name that published in the Federal Register of May 28, 2013 (78 FR 31943). We have carefully reviewed and considered the comments that were received on the draft guidance and have made changes for clarification. In particular, our revisions clarified the scope and applicability of the guidance and key terms used in the guidance. Regarding scope and applicability, we have clarified that the guidance is limited to commercial manufacturing activities. Although the principles articulated may be useful in approaching quality agreements for other kinds of activities, such as clinical research, development, or distribution, these are outside the scope of this particular document. Many comments concerned the terms ‘‘owner’’ and ‘‘contract facility.’’ Although some comments recommended that this guidance adopt the terms ‘‘contract giver’’ and ‘‘contract acceptor,’’ these terms do not align with our goal of showing how the parties to a contract manufacturing arrangement can work together to define, establish, and document agreements that delineate manufacturing activities and ensure compliance with CGMP. This guidance is being issued consistent with FDA’s good guidance practices regulation (21 CFR 10.115). The guidance represents the current thinking of FDA on Contract Manufacturing Arrangements for Drugs: Quality Agreements. It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations. mstockstill on DSK3G9T082PROD with NOTICES II. The 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) and have been approved under OMB control number 0910–0139. III. Electronic Access Persons with access to the Internet may obtain the document at either http://www.fda.gov/Drugs/Guidance ComplianceRegulatoryInformation/ Guidances/default.htm, http:// www.fda.gov/BiologicsBloodVaccines/ GuidanceComplianceRegulatory Information/Guidances/default.htm, http://www.fda.gov/AnimalVeterinary/ GuidanceComplianceEnforcement/ VerDate Sep<11>2014 18:04 Nov 22, 2016 Jkt 241001 GuidanceforIndustry/default.htm, or https://www.regulations.gov/. Dated: November 17, 2016. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2016–28122 Filed 11–22–16; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Cancer Institute Amended Notice of Meeting Notice is hereby given of a change in the meeting of the Joint Board meeting of the National Cancer Advisory Board and NCI Board of Scientific Advisors, December 5, 2016, 4:30 p.m. to December 7, 2016, 12:00 p.m., National Cancer Institute Shady Grove, Shady Grove, 9609 Medical Center Drive, 7W116, Rockville, MD 20850 which was published in the Federal Register on October 31, 2016, 81 FR 75423. The meeting notice is amended to change the date, time and location of the meeting and to cancel the Ad Hoc Subcommittee on Global Cancer Research on December 5, 2016. There will be a National Cancer Advisory Board Ad hoc Subcommittee on Clinical Investigations on December 5, 2016, from 6:00 p.m. to 7:30 p.m. at the Pooks Hill Marriott Hotel, Annapolis and Chesapeake Room, 5151 Pooks Hill Road, Bethesda, MD 20814. The Joint meeting of the National Cancer Advisory Board and NCI Board of Scientific Advisors will now be held on December 6, 2016 at the National Institutes of Health, Building 31, Conference Room 10, 31 Center Drive, Bethesda, MD 20892. The open session is from 8:30 a.m. to 3:45 p.m. The closed session will begin at 4:00 p.m. and end at 5:00 p.m. The meeting is partially closed to the public. Dated: November 17, 2016. Melanie J. Pantoja, Program Analyst, Office of Federal Advisory Committee Policy. [FR Doc. 2016–28146 Filed 11–22–16; 8:45 am] BILLING CODE 4140–01–P PO 00000 Frm 00052 Fmt 4703 Sfmt 4703 DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Institute of Diabetes and Digestive and Kidney 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 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; NIDDK DDK–B Member, Conflict Application Review. Date: December 5, 2016. Time: 11:00 a.m. to 12:00 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: Carol J. Goter-Robinson, Ph.D., Scientific Review Officer, Review Branch, DEA, NIDDK, National Institutes of Health, Room 7347, 6707 Democracy Boulevard, Bethesda, MD 20892–5452, (301) 594–7791, goterrobinsonc@ extra.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. Name of Committee: National Institute of Diabetes and Digestive and Kidney Diseases Special Emphasis Panel; PAR 14–301: NIDDK Central Repositories Sample Access (X01). Date: January 18, 2017. Time: 11:00 a.m. to 2:00 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: Najma Begum, Ph.D., Scientific Review Officer, Review Branch, DEA, NIDDK, National Institutes of Health, Room 7349, 6707 Democracy Boulevard, Bethesda, MD 20892–5452, (301) 594–8894, begumn@niddk.nih.gov. Name of Committee: National Institute of Diabetes and Digestive and Kidney Diseases Special Emphasis Panel; PAR–15–067: U01 Applications. Date: January 24, 2017. Time: 11:00 a.m. to 12:30 p.m. E:\FR\FM\23NON1.SGM 23NON1 Federal Register / Vol. 81, No. 226 / Wednesday, November 23, 2016 / Notices 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: JIAN YANG, Ph.D., Scientific Review Officer, Review Branch, DEA, NIDDK, National Institutes of Health, Room 7111, 6707 Democracy Boulevard, Bethesda, MD 20892–5452, (301) 594–7799, yangj@extra.niddk.nih.gov. (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) Dated: November 17, 2016. David Clary, Program Analyst, Office of Federal Advisory Committee Policy. [FR Doc. 2016–28148 Filed 11–22–16; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Center for Scientific Review; Notice of Closed Meeting mstockstill on DSK3G9T082PROD with NOTICES 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: Center for Scientific Review Special Emphasis Panel, Urology and Urogynecology Small Business Applications. Date: December 1–2, 2016. Time: 8:00 a.m. to 5:00 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, 6701 Rockledge Drive, Bethesda, MD 20892 (Virtual Meeting). Contact Person: Ryan G. Morris, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 4205, MSC 7814, Bethesda, MD 20892, 301–435– 1501, morrisr@csr.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. VerDate Sep<11>2014 18:04 Nov 22, 2016 Jkt 241001 (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: November 17, 2016. David Clary, Program Analyst, Office of Federal Advisory Committee Policy. [FR Doc. 2016–28142 Filed 11–22–16; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Institute on Alcohol Abuse and Alcoholism; 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 on Alcohol Abuse and Alcoholism Initial Review Group Clinical; Treatment and Health Services Research Review Subcommittee. Date: February 22, 2017. Time: 8:30 a.m. to 6:00 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, National Institute on Alcohol Abuse and Alcoholism, Terrace Conference Room 508/ 509, 5635 Fishers Lane, Rockville, MD 20851. Contact Person: Ranga V. Srinivas, Ph.D., Chief, Extramural Project Review Branch, National Institute on Alcohol Abuse and Alcoholism, National Institutes of Health, 5365 Fishers Lane, Room 2085, Rockville, MD 20852, (301) 451–2067, srinivar@ mail.nih.gov. Name of Committee: National Institute on Alcohol Abuse and Alcoholism Initial Review Group; Neuroscience Review Subcommittee. Date: March 1, 2017. Time: 8:30 a.m. to 6:00 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, National Institute on Alcohol Abuse and Alcoholism, Terrace Conference Room 508/ 509, 5635 Fishers Lane, Rockville, MD 20852. PO 00000 Frm 00053 Fmt 4703 Sfmt 4703 84599 Contact Person: Beata Buzas, Ph.D., Scientific Review Officer, National Institute on Alcohol Abuse and Alcoholism, National Institutes of Health, 5635 Fishers Lane, Room 2081, Rockville, MD 20852, 301–443–0800, bbuzas@mail.nih.gov. Name of Committee: National Institute on Alcohol Abuse and Alcoholism Initial Review Group; Epidemiology, Prevention and Behavior Research Review Subcommittee. Date: March 6, 2017. Time: 8:30 a.m. to 6:00 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, National Institute on Alcohol Abuse and Alcoholism, Terrace Conference Room 508/ 509, 5635 Fishers Lane, Rockville, MD 20852. Contact Person: Anna Ghambaryan, M.D., Ph.D., Scientific Review Officer, Extramural Project Review Branch, Office of Extramural Activities, National Institute on Alcohol Abuse and Alcoholism, National Institutes of Health, 5635 Fishers Lane, Room 2019, Rockville, MD 20852, 301–443–4032, anna.ghambaryan@nih.gov. Name of Committee: National Institute on Alcohol Abuse and Alcoholism Initial Review Group; Biomedical Research Review Subcommittee. Date: March 7, 2017. Time: 8:00 a.m. to 6:00 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, National Institute on Alcohol Abuse and Alcoholism, Terrace Conference Room 508/ 509, 5635 Fishers Lane, Rockville, MD 20851. Contact Person: Philippe Marmillot, Ph.D., Scientific Review Officer, National Institute on Alcohol Abuse and Alcoholism, National Institutes of Health, 5635 Fishers Lane, Room 2017, Bethesda, MD 20892, 301–443–2861, marmillotp@mail.nih.gov. (Catalogue of Federal Domestic Assistance Program Nos. 93.271, Alcohol Research Career Development Awards for Scientists and Clinicians; 93.272, Alcohol National Research Service Awards for Research Training; 93.273, Alcohol Research Programs; 93.891, Alcohol Research Center Grants; 93.701, ARRA Related Biomedical Research and Research Support Awards., National Institutes of Health, HHS) Dated: November 17, 2016. Melanie J. Pantoja, Program Analyst, Office of Federal Advisory Committee Policy. [FR Doc. 2016–28147 Filed 11–22–16; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Center for Scientific Review; 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. E:\FR\FM\23NON1.SGM 23NON1

Agencies

[Federal Register Volume 81, Number 226 (Wednesday, November 23, 2016)]
[Notices]
[Pages 84598-84599]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-28148]


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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 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 Diabetes and Digestive 
and Kidney Diseases Special Emphasis Panel; NIDDK DDK-B Member, 
Conflict Application Review.
    Date: December 5, 2016.
    Time: 11:00 a.m. to 12:00 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: Carol J. Goter-Robinson, Ph.D., Scientific 
Review Officer, Review Branch, DEA, NIDDK, National Institutes of 
Health, Room 7347, 6707 Democracy Boulevard, Bethesda, MD 20892-
5452, (301) 594-7791, goterrobinsonc@extra.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.

    Name of Committee: National Institute of Diabetes and Digestive 
and Kidney Diseases Special Emphasis Panel; PAR 14-301: NIDDK 
Central Repositories Sample Access (X01).
    Date: January 18, 2017.
    Time: 11:00 a.m. to 2:00 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: Najma Begum, Ph.D., Scientific Review Officer, 
Review Branch, DEA, NIDDK, National Institutes of Health, Room 7349, 
6707 Democracy Boulevard, Bethesda, MD 20892-5452, (301) 594-8894, 
begumn@niddk.nih.gov.

    Name of Committee: National Institute of Diabetes and Digestive 
and Kidney Diseases Special Emphasis Panel; PAR-15-067: U01 
Applications.
    Date: January 24, 2017.
    Time: 11:00 a.m. to 12:30 p.m.

[[Page 84599]]

    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: JIAN YANG, Ph.D., Scientific Review Officer, 
Review Branch, DEA, NIDDK, National Institutes of Health, Room 7111, 
6707 Democracy Boulevard, Bethesda, MD 20892-5452, (301) 594-7799, 
yangj@extra.niddk.nih.gov.

(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)

     Dated: November 17, 2016.
David Clary,
 Program Analyst, Office of Federal Advisory Committee Policy.
[FR Doc. 2016-28148 Filed 11-22-16; 8:45 am]
 BILLING CODE 4140-01-P