National Institute of Diabetes and Digestive and Kidney Diseases: Notice of Closed Meetings, 84598-84599 [2016-28148]
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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This guidance replaces the draft
guidance of the same name that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draft guidance and have made changes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.
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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
https://www.fda.gov/Drugs/Guidance
ComplianceRegulatoryInformation/
Guidances/default.htm, https://
www.fda.gov/BiologicsBloodVaccines/
GuidanceComplianceRegulatory
Information/Guidances/default.htm,
https://www.fda.gov/AnimalVeterinary/
GuidanceComplianceEnforcement/
VerDate Sep<11>2014
18:04 Nov 22, 2016
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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]
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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.
E:\FR\FM\23NON1.SGM
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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
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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
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]]>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
