81 FR 84598 - National Institute of Diabetes and Digestive and Kidney Diseases: Notice of Closed Meetings

DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health

Federal Register Volume 81, Issue 226 (November 23, 2016)

Page Range		84598-84599
FR Document		2016-28148

Federal Register, Volume 81 Issue 226 (Wednesday, November 23, 2016)

[Federal Register Volume 81, Number 226 (Wednesday, November 23, 2016)]
[Notices]
[Pages 84598-84599]
From the Federal Register Online  [www.thefederalregister.org]
[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, [email protected].

    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, 
[email protected].

    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, 
[email protected].

(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

84598 Federal Register / Vol. 81, No. 226 / Wednesday, November 23, 2016 / Notices

This guidance replaces the draft GuidanceforIndustry/default.htm, or DEPARTMENT OF HEALTH AND
guidance of the same name that https://www.regulations.gov/. HUMAN SERVICES
published in the Federal Register of Dated: November 17, 2016.
May 28, 2013 (78 FR 31943). We have National Institutes of Health
carefully reviewed and considered the Leslie Kux,
comments that were received on the Associate Commissioner for Policy. National Institute of Diabetes and
draft guidance and have made changes [FR Doc. 2016–28122 Filed 11–22–16; 8:45 am] Digestive and Kidney Diseases: Notice
for clarification. In particular, our BILLING CODE 4164–01–P
of Closed Meetings
revisions clarified the scope and Pursuant to section 10(d) of the
applicability of the guidance and key Federal Advisory Committee Act, as
terms used in the guidance. DEPARTMENT OF HEALTH AND amended (5 U.S.C. App.), notice is
Regarding scope and applicability, we HUMAN SERVICES hereby given of the following meetings.
have clarified that the guidance is The meetings will be closed to the
limited to commercial manufacturing National Institutes of Health public in accordance with the
activities. Although the principles provisions set forth in sections
articulated may be useful in National Cancer Institute Amended 552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
approaching quality agreements for Notice of Meeting as amended. The grant applications and
other kinds of activities, such as clinical the discussions could disclose
research, development, or distribution, Notice is hereby given of a change in confidential trade secrets or commercial
these are outside the scope of this the meeting of the Joint Board meeting property such as patentable material,
particular document. of the National Cancer Advisory Board and personal information concerning
Many comments concerned the terms and NCI Board of Scientific Advisors, individuals associated with the grant
‘‘owner’’ and ‘‘contract facility.’’ December 5, 2016, 4:30 p.m. to applications, the disclosure of which
Although some comments December 7, 2016, 12:00 p.m., National would constitute a clearly unwarranted
recommended that this guidance adopt Cancer Institute Shady Grove, Shady invasion of personal privacy.
the terms ‘‘contract giver’’ and ‘‘contract Grove, 9609 Medical Center Drive,
acceptor,’’ these terms do not align with Name of Committee: National Institute of
7W116, Rockville, MD 20850 which was Diabetes and Digestive and Kidney Diseases
our goal of showing how the parties to published in the Federal Register on Special Emphasis Panel; NIDDK DDK–B
a contract manufacturing arrangement
October 31, 2016, 81 FR 75423. Member, Conflict Application Review.
can work together to define, establish, Date: December 5, 2016.
and document agreements that delineate The meeting notice is amended to Time: 11:00 a.m. to 12:00 p.m.
manufacturing activities and ensure change the date, time and location of the Agenda: To review and evaluate grant
compliance with CGMP. meeting and to cancel the Ad Hoc applications.
This guidance is being issued Subcommittee on Global Cancer Place: National Institutes of Health, Two
consistent with FDA’s good guidance Research on December 5, 2016. There Democracy Plaza, 6707 Democracy
practices regulation (21 CFR 10.115). will be a National Cancer Advisory Boulevard, Bethesda, MD 20892, (Telephone
Conference Call).
The guidance represents the current Board Ad hoc Subcommittee on Clinical Contact Person: Carol J. Goter-Robinson,
thinking of FDA on Contract Investigations on December 5, 2016, Ph.D., Scientific Review Officer, Review
Manufacturing Arrangements for Drugs: from 6:00 p.m. to 7:30 p.m. at the Pooks Branch, DEA, NIDDK, National Institutes of
Quality Agreements. It does not Hill Marriott Hotel, Annapolis and Health, Room 7347, 6707 Democracy
establish any rights for any person and Chesapeake Room, 5151 Pooks Hill Boulevard, Bethesda, MD 20892–5452, (301)
is not binding on FDA or the public. Road, Bethesda, MD 20814. The Joint 594–7791, goterrobinsonc@
You can use an alternative approach if extra.niddk.nih.gov.
meeting of the National Cancer
it satisfies the requirements of the This notice is being published less than 15
Advisory Board and NCI Board of days prior to the meeting due to the timing
applicable statutes and regulations. Scientific Advisors will now be held on limitations imposed by the review and
II. The Paperwork Reduction Act of December 6, 2016 at the National funding cycle.
1995 Institutes of Health, Building 31, Name of Committee: National Institute of
This guidance refers to previously Conference Room 10, 31 Center Drive, Diabetes and Digestive and Kidney Diseases
approved collections of information Bethesda, MD 20892. The open session Special Emphasis Panel; PAR 14–301: NIDDK
is from 8:30 a.m. to 3:45 p.m. The closed Central Repositories Sample Access (X01).
found in FDA regulations. These
session will begin at 4:00 p.m. and end Date: January 18, 2017.
collections of information are subject to Time: 11:00 a.m. to 2:00 p.m.
review by the Office of Management and at 5:00 p.m. The meeting is partially Agenda: To review and evaluate grant
Budget (OMB) under the Paperwork closed to the public. applications.
Reduction Act of 1995 (44 U.S.C. 3501– Dated: November 17, 2016. Place: National Institutes of Health, Two
3520) and have been approved under Democracy Plaza, 6707 Democracy
Melanie J. Pantoja,
OMB control number 0910–0139. Boulevard, Bethesda, MD 20892, (Telephone
Program Analyst, Office of Federal Advisory Conference Call).
III. Electronic Access Committee Policy. Contact Person: Najma Begum, Ph.D.,
Persons with access to the Internet [FR Doc. 2016–28146 Filed 11–22–16; 8:45 am] Scientific Review Officer, Review Branch,
may obtain the document at either BILLING CODE 4140–01–P
DEA, NIDDK, National Institutes of Health,
Room 7349, 6707 Democracy Boulevard,
http://www.fda.gov/Drugs/Guidance
mstockstill on DSK3G9T082PROD with NOTICES

Bethesda, MD 20892–5452, (301) 594–8894,
ComplianceRegulatoryInformation/ begumn@niddk.nih.gov.
Guidances/default.htm, http://
Name of Committee: National Institute of
www.fda.gov/BiologicsBloodVaccines/ Diabetes and Digestive and Kidney Diseases
GuidanceComplianceRegulatory Special Emphasis Panel; PAR–15–067: U01
Information/Guidances/default.htm, Applications.
http://www.fda.gov/AnimalVeterinary/ Date: January 24, 2017.
GuidanceComplianceEnforcement/ Time: 11:00 a.m. to 12:30 p.m.

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Federal Register / Vol. 81, No. 226 / Wednesday, November 23, 2016 / Notices 84599

Agenda: To review and evaluate grant (Catalogue of Federal Domestic Assistance Contact Person: Beata Buzas, Ph.D.,
applications. Program Nos. 93.306, Comparative Medicine; Scientific Review Officer, National Institute
Place: National Institutes of Health, Two 93.333, Clinical Research, 93.306, 93.333, on Alcohol Abuse and Alcoholism, National
Democracy Plaza, 6707 Democracy 93.337, 93.393–93.396, 93.837–93.844, Institutes of Health, 5635 Fishers Lane, Room
Boulevard, Bethesda, MD 20892, (Telephone 93.846–93.878, 93.892, 93.893, National 2081, Rockville, MD 20852, 301–443–0800,
Conference Call). Institutes of Health, HHS) bbuzas@mail.nih.gov.
Contact Person: JIAN YANG, Ph.D., Name of Committee: National Institute on
Dated: November 17, 2016.
Scientific Review Officer, Review Branch, Alcohol Abuse and Alcoholism Initial
DEA, NIDDK, National Institutes of Health, David Clary, Review Group; Epidemiology, Prevention
Room 7111, 6707 Democracy Boulevard, Program Analyst, Office of Federal Advisory and Behavior Research Review
Bethesda, MD 20892–5452, (301) 594–7799, Committee Policy. Subcommittee.
yangj@extra.niddk.nih.gov. [FR Doc. 2016–28142 Filed 11–22–16; 8:45 am] Date: March 6, 2017.
(Catalogue of Federal Domestic Assistance Time: 8:30 a.m. to 6:00 p.m.
BILLING CODE 4140–01–P
Program Nos. 93.847, Diabetes, Agenda: To review and evaluate grant
Endocrinology and Metabolic Research; applications.
93.848, Digestive Diseases and Nutrition Place: National Institutes of Health,
DEPARTMENT OF HEALTH AND National Institute on Alcohol Abuse and
Research; 93.849, Kidney Diseases, Urology HUMAN SERVICES
and Hematology Research, National Institutes Alcoholism, Terrace Conference Room 508/
of Health, HHS) 509, 5635 Fishers Lane, Rockville, MD 20852.
National Institutes of Health Contact Person: Anna Ghambaryan, M.D.,
Dated: November 17, 2016. Ph.D., Scientific Review Officer, Extramural
David Clary, National Institute on Alcohol Abuse Project Review Branch, Office of Extramural
Program Analyst, Office of Federal Advisory and Alcoholism; Notice of Closed Activities, National Institute on Alcohol
Committee Policy. Meetings Pursuant to Section 10(d) of Abuse and Alcoholism, National Institutes of
the Federal Advisory Committee Act, Health, 5635 Fishers Lane, Room 2019,
[FR Doc. 2016–28148 Filed 11–22–16; 8:45 am] Rockville, MD 20852, 301–443–4032,
as Amended (5 U.S.C. App.), Notice Is
BILLING CODE 4140–01–P anna.ghambaryan@nih.gov.
Hereby Given of the Following Name of Committee: National Institute on
Meetings. Alcohol Abuse and Alcoholism Initial
DEPARTMENT OF HEALTH AND Review Group; Biomedical Research Review
The meetings will be closed to the
HUMAN SERVICES Subcommittee.
public in accordance with the Date: March 7, 2017.
provisions set forth in sections Time: 8:00 a.m. to 6:00 p.m.
National Institutes of Health
552b(c)(4) and 552b(c)(6), Title 5 U.S.C., Agenda: To review and evaluate grant
Center for Scientific Review; Notice of as amended. The grant applications and applications.
the discussions could disclose Place: National Institutes of Health,
Closed Meeting National Institute on Alcohol Abuse and
confidential trade secrets or commercial
Pursuant to section 10(d) of the property such as patentable material, Alcoholism, Terrace Conference Room 508/
Federal Advisory Committee Act, as 509, 5635 Fishers Lane, Rockville, MD 20851.
and personal information concerning Contact Person: Philippe Marmillot, Ph.D.,
amended (5 U.S.C. App.), notice is individuals associated with the grant Scientific Review Officer, National Institute
hereby given of the following meeting. applications, the disclosure of which on Alcohol Abuse and Alcoholism, National
The meeting will be closed to the would constitute a clearly unwarranted Institutes of Health, 5635 Fishers Lane, Room
public in accordance with the invasion of personal privacy. 2017, Bethesda, MD 20892, 301–443–2861,
provisions set forth in sections marmillotp@mail.nih.gov.
Name of Committee: National Institute on
552b(c)(4) and 552b(c)(6), Title 5 U.S.C., Alcohol Abuse and Alcoholism Initial (Catalogue of Federal Domestic Assistance
as amended. The grant applications and Review Group Clinical; Treatment and Program Nos. 93.271, Alcohol Research
the discussions could disclose Health Services Research Review Career Development Awards for Scientists
confidential trade secrets or commercial Subcommittee. and Clinicians; 93.272, Alcohol National
property such as patentable material, Date: February 22, 2017. Research Service Awards for Research
and personal information concerning Time: 8:30 a.m. to 6:00 p.m. Training; 93.273, Alcohol Research Programs;
Agenda: To review and evaluate grant 93.891, Alcohol Research Center Grants;
individuals associated with the grant
applications. 93.701, ARRA Related Biomedical Research
applications, the disclosure of which and Research Support Awards., National
would constitute a clearly unwarranted Place: National Institutes of Health,
National Institute on Alcohol Abuse and Institutes of Health, HHS)
invasion of personal privacy. Alcoholism, Terrace Conference Room 508/ Dated: November 17, 2016.
Name of Committee: Center for Scientific 509, 5635 Fishers Lane, Rockville, MD 20851. Melanie J. Pantoja,
Review Special Emphasis Panel, Urology and Contact Person: Ranga V. Srinivas, Ph.D.,
Program Analyst, Office of Federal Advisory
Urogynecology Small Business Applications. Chief, Extramural Project Review Branch,
Committee Policy.
Date: December 1–2, 2016. National Institute on Alcohol Abuse and
Time: 8:00 a.m. to 5:00 p.m. Alcoholism, National Institutes of Health, [FR Doc. 2016–28147 Filed 11–22–16; 8:45 am]
Agenda: To review and evaluate grant 5365 Fishers Lane, Room 2085, Rockville, BILLING CODE 4140–01–P
applications. MD 20852, (301) 451–2067, srinivar@
Place: National Institutes of Health, 6701 mail.nih.gov.
Rockledge Drive, Bethesda, MD 20892 Name of Committee: National Institute on DEPARTMENT OF HEALTH AND
(Virtual Meeting). Alcohol Abuse and Alcoholism Initial HUMAN SERVICES
Contact Person: Ryan G. Morris, Ph.D., Review Group; Neuroscience Review
Scientific Review Officer, Center for Subcommittee. National Institutes of Health
mstockstill on DSK3G9T082PROD with NOTICES

Scientific Review, National Institutes of Date: March 1, 2017.
Health, 6701 Rockledge Drive, Room 4205, Time: 8:30 a.m. to 6:00 p.m. Center for Scientific Review; Notice of
MSC 7814, Bethesda, MD 20892, 301–435– Agenda: To review and evaluate grant Closed Meeting
1501, morrisr@csr.nih.gov. applications.
This notice is being published less than 15 Place: National Institutes of Health, Pursuant to section 10(d) of the
days prior to the meeting due to the timing National Institute on Alcohol Abuse and Federal Advisory Committee Act, as
limitations imposed by the review and Alcoholism, Terrace Conference Room 508/ amended (5 U.S.C. App.), notice is
funding cycle. 509, 5635 Fishers Lane, Rockville, MD 20852. hereby given of the following meeting.

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Document Created: 2016-11-23 05:29:46
Document Modified: 2016-11-23 05:29:46

Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Notices
Dates		December 5, 2016.
FR Citation		81 FR 84598

81 FR 84598 - National Institute of Diabetes and Digestive and Kidney Diseases: Notice of Closed Meetings

DEPARTMENT OF HEALTH AND HUMAN SERVICESNational Institutes of Health

Federal Register Volume 81, Issue 226 (November 23, 2016)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health