National Heart, Lung, and Blood Institute; Notice of Closed Meetings, 83855 [2016-27997]
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Federal Register / Vol. 81, No. 225 / Tuesday, November 22, 2016 / Notices
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institutes of Health
National Heart, Lung, and Blood
Institute; Notice of Closed Meetings
Submission for OMB Review; 30-Day
Comment Request; Materials To
Support NIH Serving as an IRB of
Record or a Single IRB for Outside
Institutions (Office of the Director)
sradovich on DSK3GMQ082PROD 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 meetings.
The meetings will be closed to the
public in accordance with the
provisions set forth in section
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 Heart, Lung,
and Blood Institute Special Emphasis Panel;
Heart, Lung, Blood and Sleep Conference
Support Applications.
Date: December 12–13, 2016.
Time: 9:00 a.m. to 6:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 6701
Rockledge Drive, Room 7196, Bethesda, MD
20892 (Virtual Meeting).
Contact Person: Stephanie J. Webb, Ph.D.,
Scientific Review Officer, Office of Scientific
Review/DERA, National Heart, Lung, and
Blood Institute, 6701 Rockledge Drive, Room
7196, Bethesda, MD 20892, 301–435–0291,
stephanie.webb@nih.gov.
Name of Committee: National Heart, Lung,
and Blood Institute Special Emphasis Panel;
R25 Diversity: Short-Term Research
Education to Increase Diversity.
Date: December 12, 2016.
Time: 10:00 a.m. to 11:30 a.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 6701
Rockledge Drive, Room 7189, Bethesda, MD
20892 (Telephone Conference Call).
Contact Person: Stephanie L. Constant,
Ph.D., Scientific Review Officer, Office of
Scientific Review/DERA, National Heart,
Lung, and Blood Institute, 6701 Rockledge
Drive, Room 7189, Bethesda, MD 20892, 301–
443–8784, constantsl@nhlbi.nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.233, National Center for
Sleep Disorders Research; 93.837, Heart and
Vascular Diseases Research; 93.838, Lung
Diseases Research; 93.839, Blood Diseases
and Resources Research, National Institutes
of Health, HHS)
Dated: November 16, 2016.
Michelle Trout,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2016–27997 Filed 11–21–16; 8:45 am]
BILLING CODE 4140–01–P
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Jkt 241001
AGENCY:
National Institutes of Health,
HHS.
ACTION:
Notice.
In compliance with the
Paperwork Reduction Act of 1995, the
National Institutes of Health (NIH) has
submitted to the Office of Management
and Budget (OMB) a request for review
and approval of the information
collection listed below. This proposed
information collection was previously
published in the Federal Register on
August 22, 2016, page 56667 (81 FR
56667) and allowed 60 days for public
comment. No public comments were
received. The purpose of this notice is
to allow an additional 30 days for public
comment.
DATES: Comments regarding this
information collection are best assured
of having their full effect if received
within 30 days of the date of this
publication.
SUMMARY:
Written comments and/or
suggestions regarding the items(s)
contained in this notice, especially
regarding the estimated public burden
and associated response time, should be
directed to the: Office of Management
and Budget, Office of Regulatory Affairs,
OIRA_submission@omb.eop.gov or by
fax to 202–395–6974, Attention: Desk
Officer for NIH.
FOR FURTHER INFORMATION CONTACT: To
request more information on the
proposed project or to obtain a copy of
the data collection plans and
instruments, contact: Julia Slutsman,
Health Science Policy Analyst, Office of
Human Subjects Research Protections
(OHSRP), IRP, OD, NIH, Building 10,
Room 1C154, 10 Center Drive, Bethesda,
MD 20892, or call non-toll-free number
301–402–3444 or email your request,
including your address to: PHERRB@
mail.nih.gov. Formal requests for
additional materials must be requested
in writing.
SUPPLEMENTARY INFORMATION: The Office
of Human Subjects Research Protections
(OHSRP), Office of the Director (OD),
National Institutes of Health, may not
conduct or sponsor, and the respondent
is not required to respond to, an
information collection that has been
extended, revised, or implemented on or
ADDRESSES:
PO 00000
Frm 00059
Fmt 4703
Sfmt 4703
83855
after October 1, 1995, unless it displays
a currently valid OMB control number.
In compliance with Section
3507(a)(1)(D) of the Paperwork
Reduction Act of 1995, the National
Institutes of Health has submitted to the
Office of Management and Budget
(OMB) a request for review and
approval of the information collection
listed below.
Proposed Collection: Materials to
Support NIH Serving As an IRB of
Record or a Single IRB for Outside
Institutions, 0925-New, Office of Human
Subjects Research Protections (OHSRP),
Office of the Director, National
Institutes of Health (NIH).
Need and Use of Information
Collection: The NIH Human Research
Protections Program (HRPP) is preparing
to implement the recent ‘‘NIH Policy on
the Use of a Single Institutional Review
Board (sIRB) of Record for Multi-Site
Research,’’ which requires the use of a
single IRB of record for human subject
protections review of certain multisite
studies. Additionally, the NIH and HHS
have recently established the Public
Health Emergency Research Review
Board (PHERRB) mechanism, for human
subject protections review of certain—
typically multisite—public health
emergency research studies. Any of the
12 NIH intramural IRBs can be
designated to serve as the PHERRB for
review of a public health emergency
research protocol. Finally, proposed
changes to federal human subject
protections regulations, if finalized, will
require the use of single IRB review for
the majority of HHS funded, multi-site
studies.
To meet all of these needs, and
support efficient single IRB review,
researchers at outside institutions will
need to provide information to the NIH
HRPP, which includes the NIH
intramural IRBs, using materials
developed by the NIH Office of Human
Subject Protections. The required
materials include: The Application for
PHERRB Review (APR); the Initial
Review Local Context Worksheet
(IRLCW); and the Continuing Review
Local Context Worksheet (CRLCW). This
information collection is intended to
provide the NIH HRPP and the NIH IRBs
with information necessary for NIH to
maintain regulatory compliance in its
conduct of human subject protections
review when an NIH IRB serves an IRB
of record for multisite research and to
provide high quality and timely human
subject protections reviews.
OMB approval is requested for 3
years. There are no costs to respondents
other than their time. The total
estimated annual burden hours are 790.
E:\FR\FM\22NON1.SGM
22NON1
Agencies
[Federal Register Volume 81, Number 225 (Tuesday, November 22, 2016)]
[Notices]
[Page 83855]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-27997]
[[Page 83855]]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
National Heart, Lung, and Blood Institute; 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 section 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 Heart, Lung, and Blood Institute
Special Emphasis Panel; Heart, Lung, Blood and Sleep Conference
Support Applications.
Date: December 12-13, 2016.
Time: 9:00 a.m. to 6:00 p.m.
Agenda: To review and evaluate grant applications.
Place: National Institutes of Health, 6701 Rockledge Drive, Room
7196, Bethesda, MD 20892 (Virtual Meeting).
Contact Person: Stephanie J. Webb, Ph.D., Scientific Review
Officer, Office of Scientific Review/DERA, National Heart, Lung, and
Blood Institute, 6701 Rockledge Drive, Room 7196, Bethesda, MD
20892, 301-435-0291, stephanie.webb@nih.gov.
Name of Committee: National Heart, Lung, and Blood Institute
Special Emphasis Panel; R25 Diversity: Short-Term Research Education
to Increase Diversity.
Date: December 12, 2016.
Time: 10:00 a.m. to 11:30 a.m.
Agenda: To review and evaluate grant applications.
Place: National Institutes of Health, 6701 Rockledge Drive, Room
7189, Bethesda, MD 20892 (Telephone Conference Call).
Contact Person: Stephanie L. Constant, Ph.D., Scientific Review
Officer, Office of Scientific Review/DERA, National Heart, Lung, and
Blood Institute, 6701 Rockledge Drive, Room 7189, Bethesda, MD
20892, 301-443-8784, constantsl@nhlbi.nih.gov.
(Catalogue of Federal Domestic Assistance Program Nos. 93.233,
National Center for Sleep Disorders Research; 93.837, Heart and
Vascular Diseases Research; 93.838, Lung Diseases Research; 93.839,
Blood Diseases and Resources Research, National Institutes of
Health, HHS)
Dated: November 16, 2016.
Michelle Trout,
Program Analyst, Office of Federal Advisory Committee Policy.
[FR Doc. 2016-27997 Filed 11-21-16; 8:45 am]
BILLING CODE 4140-01-P