National Heart, Lung, and Blood Institute; Notice of Closed Meeting, 56666-56667 [2016-19882]
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Federal Register / Vol. 81, No. 162 / Monday, August 22, 2016 / Notices
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.
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;
Reproductive Health Epidemiology.
Date: September 1, 2016.
Time: 3:00 p.m. to 5:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 6701
Rockledge Drive, Bethesda, MD 20892,
(Telephone Conference Call).
Contact Person: Valerie Durrant, PhD.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 3148,
MSC 7770, Bethesda, MD 20892, (301) 827–
6390, durrantv@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.
(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: August 16, 2016.
Natasha M. Copeland,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2016–19884 Filed 8–19–16; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Heart, Lung, and Blood
Institute; Notice of Meeting
Pursuant to section 10(a) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. App.), notice is
hereby given of a meeting of the Sickle
Cell Disease Advisory Committee.
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The meeting will be open to the
public, with attendance limited to space
available. Individuals who plan to
attend and need special assistance, such
as sign language interpretation or other
reasonable accommodations, should
notify the Contact Person listed below
in advance of the meeting.
Name of Committee: Sickle Cell Disease
Advisory Committee.
Date: September 23, 2016.
Time: 8:30 a.m. to 3:00 p.m.
Agenda: Discussion of Programs.
Place: National Institutes of Health, 6701
Rockledge Drive, 9th Floor, Room 9112/9116,
Bethesda, MD 20892.
Contact Person: W. Keith Hoots, MD,
Director, Division of Blood Diseases and
Resources, National Heart, Lung, and Blood
Institute, 6701 Rockledge Drive, Suite 9030,
Bethesda, MD 20892, 301–435–0080,
hootswk@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: August 16, 2016.
Michelle Trout,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2016–19881 Filed 8–19–16; 8:45 am]
Contact Person: Rene Etcheberrigaray, MD,
Deputy Director, Center for Scientific
Review, National Institutes of Health, 6701
Rockledge Drive, Room 3030, MSC 7776,
Bethesda, MD 20892, (301) 435–1111,
etcheber@csr.nih.gov.
Any interested person may file written
comments with the committee by forwarding
the statement to the Contact Person listed on
this notice. The statement should include the
name, address, telephone number and when
applicable, the business or professional
affiliation of the interested person.
Information is also available on the
Institute’s/Center’s home page: https://
public.csr.nih.gov/aboutcsr/
CSROrganization/Pages/CSRAC.aspx, where
an agenda and any additional information for
the meeting will be posted when available.
(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: August 16, 2016.
Sylvia L. Neal,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2016–19886 Filed 8–19–16; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
BILLING CODE 4140–01–P
National Institutes of Health
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Heart, Lung, and Blood
Institute; Notice of Closed Meeting
National Institutes of Health
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.
Center for Scientific Review; Notice of
Meeting
Pursuant to section 10(a) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. App.), notice is
hereby given of a meeting of the Center
for Scientific Review Advisory Council.
The meeting will be open to the
public, with attendance limited to space
available. Individuals who plan to
attend and need special assistance, such
as sign language interpretation or other
reasonable accommodations, should
notify the Contact Person listed below
in advance of the meeting.
Name of Committee: Center for Scientific
Review Advisory Council.
Date: September 26, 2016.
Time: 8:30 a.m. to 3:30 p.m.
Agenda: Provide advice to the Director,
Center for Scientific Review (CSR), on
matters related to planning, execution,
conduct, support, review, evaluation, and
receipt and referral of grant applications at
CSR.
Place: Bethesda Marriott, Congressional
Ballroom, 5151 Pooks Hill Road, Bethesda,
MD 20814.
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Name of Committee: National Heart, Lung,
and Blood Institute Special Emphasis Panel;
Genetic Basis of Monogenic Diseases.
Date: September 15, 2016.
Time: 3:00 p.m. to 5:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 6701
Rockledge Drive, Room 7200, Bethesda, MD
20892 (Telephone Conference Call).
Contact Person: Michael P. Reilly, Ph.D.,
Scientific Review Officer, Office of Scientific
Review/DERA, National Heart, Lung, and
Blood Institute, 6701 Rockledge Drive, Room
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Federal Register / Vol. 81, No. 162 / Monday, August 22, 2016 / Notices
7200, Bethesda, MD 20892, 301–496–9659,
reillymp@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: August 16, 2016.
Michelle Trout,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2016–19882 Filed 8–19–16; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Proposed Collection; 60-Day Comment
Request; Materials To Support NIH
Serving as an Institutional Review
Board (IRB) of Record or a Single IRB
for Outside Institutions
To provide the opportunity
for public comment on proposed data
collection projects, the Office of Human
Subjects Research Protections (OHSRP),
Office of the Director, National
Institutes of Health (NIH), will publish
periodic summaries of proposed
projects to be submitted to the Office of
Management and Budget (OMB) for
review and approval.
DATES: Comments regarding this
information collection are best assured
of having their full effect if received
with 60 days of the date of this
publication.
FOR FURTHER INFORMATION CONTACT: To
obtain a copy of the data collection
plans and instruments, submit
comments in writing, or request more
information on the proposed project,
contact: Dr. 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 plans and instruments must
be requested in writing.
SUPPLEMENTARY INFORMATION: In
compliance with the requirement of
Section 350(c)(2)(A) of the Paperwork
Reduction Act of 1995, written
comments and/or suggestions from the
public and affected agencies are invited
on one or more of the following points:
(1) Whether the proposed collection of
information is necessary for the proper
performance of the function of the
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SUMMARY:
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agency, including whether the
information will have practical utility;
(2) The accuracy of the agency’s
estimate of the burden of the proposed
collection of information, including the
validity of the methodology and
assumptions used; (3) Ways to enhance
the quality, utility, and clarity of the
information to be collected; and (4)
Ways to minimize the burden of the
collection of information on those who
are to respond, including the use of
appropriate automated, electronic,
mechanical, or other technological
collection techniques or other forms of
information technology.
PROPOSED COLLECTION: Materials
to support the NIH Serving As an
Institutional Review Board (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 multi-site—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 which 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 the NIH to maintain
regulatory compliance in its conduct of
human subject protections review when
an NIH IRB serves an IRB of record for
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multi-site research and to provide high
quality and timely human subject
protections reviews.
When an NIH IRB serves as the
PHERRB, investigators seeking PHERRB
human subject protections review will
need to submit their request using the
‘‘Application for PHERRB Review
(APR).’’ This application will be used to
collect information to allow the NIH to
evaluate public health emergency
research protocol submissions’
suitability for review by the PHERRB.
The form will collect the investigator’s
name, work address, phone, fax and
email, the curriculum vitae of the
principal investigator and all coinvestigators on the research study, and
a detailed description of the proposed
research study including the funding
source for the study. The APR will
facilitate the timely review of public
health emergency protocols for human
subjects protections review by the
PHERRB for protocols meeting PHERRB
review eligibility criteria.
As part of meeting regulatory
requirements for IRB review of protocols
and ensuring the welfare and safety of
human subjects, IRBs need to consider
local context considerations, that is the
sum of state and local laws related to
the conduct of human subjects research,
relevant institutional policies and
resources, research team qualifications
and contextual considerations particular
to the site where research is taking
place. When an NIH IRB serves as the
IRB of record for institutions
participating in a multisite study, it is
necessary for IRBS to have a systematic
way of collecting information about
local context.
To facilitate local context information
collection, the NIH has developed two
forms: The Initial Review Local Context
Worksheet (IRLCW) and the Continuing
Review Local Context Worksheet
(CRLCW). The IRLCW will be submitted
by investigators at each institution
participating in a multi-site study for
which an NIH IRB is the IRB of record
at the time of submission of the research
protocol. The CRLCW will be submitted
at the time of continuing review of the
protocol. These forms asks principal
investigators to PIs to provide their
name and the name of the institution
with which they are affiliated, as well
as names of regulatory points of contact
and information about institutional
policies and state and local laws on
issues related to informed consent,
legally authorized representative
designation procedures and other
relevant laws. This data collection is
authorized pursuant to sections 301,
307, 465, and 478A of the Public Health
Service Act [42 U.S.C. 241, 242l, 286
E:\FR\FM\22AUN1.SGM
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Agencies
[Federal Register Volume 81, Number 162 (Monday, August 22, 2016)]
[Notices]
[Pages 56666-56667]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-19882]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
National Heart, Lung, and Blood Institute; 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.
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 Heart, Lung, and Blood Institute
Special Emphasis Panel; Genetic Basis of Monogenic Diseases.
Date: September 15, 2016.
Time: 3:00 p.m. to 5:00 p.m.
Agenda: To review and evaluate grant applications.
Place: National Institutes of Health, 6701 Rockledge Drive, Room
7200, Bethesda, MD 20892 (Telephone Conference Call).
Contact Person: Michael P. Reilly, Ph.D., Scientific Review
Officer, Office of Scientific Review/DERA, National Heart, Lung, and
Blood Institute, 6701 Rockledge Drive, Room
[[Page 56667]]
7200, Bethesda, MD 20892, 301-496-9659, reillymp@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: August 16, 2016.
Michelle Trout,
Program Analyst, Office of Federal Advisory Committee Policy.
[FR Doc. 2016-19882 Filed 8-19-16; 8:45 am]
BILLING CODE 4140-01-P