National Institute of Arthritis and Musculoskeletal and Skin Diseases; Notice of Closed Meeting, 11221-11222 [2018-05084]
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Federal Register / Vol. 83, No. 50 / Wednesday, March 14, 2018 / Notices
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Laboratory Animal Welfare:
Coordination and Harmonization of
Regulations and Policies
AGENCY:
National Institutes of Health,
HHS.
ACTION:
Notice; request for comments.
The National Institutes of
Health (NIH) is seeking information to
improve the coordination of regulations
and policies with respect to research
with laboratory animals as required by
the 21st Century Cures Act, Section
2034(d). The request for information is
a coordinated effort of the Director of
the National Institutes of Health in
collaboration with the Secretary of
Agriculture and the Commissioner of
Food and Drugs to reduce
administrative burden on investigators
while maintaining the integrity and
credibility of research findings and
protection of research animals.
DATES: The Request for Information
regarding the proposed actions that the
agencies have identified to improve
coordination and harmonization of
regulations and policies is open for
public comment for a period of 90 days.
Comments must be submitted
electronically at https://grants.nih.gov/
grants/rfi/rfi.cfm?ID=71 and must be
received by June 12, 2018 to ensure
consideration.
FOR FURTHER INFORMATION CONTACT:
Patricia Brown, Office of Laboratory
Animal Welfare (OLAW), Office of
Extramural Research, National Institutes
of Health, Suite 360, 6705 Rockledge
Drive, Bethesda, MD 20892–7982,
phone: 301–496–7163, email: olaw@
od.nih.gov.
SUPPLEMENTARY INFORMATION:
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SUMMARY:
I. Background
This request for information is a
coordinated effort of the Director of the
National Institutes of Health in
collaboration with the Secretary of
Agriculture and the Commissioner of
Food and Drugs to reduce
administrative burden on investigators
while maintaining the integrity and
credibility of research findings and
protection of research animals.
Section 2034(d) of the 21st Century
Cures Act (Pub. L. 114–255) was
enacted December 13, 2016 and requires
that the NIH in collaboration with the
United States Department of Agriculture
(USDA) and the Food and Drug
Administration (FDA) complete a
review of applicable regulations and
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policies for the care and use of
laboratory animals and make revisions
to reduce administrative burden on
investigators. In carrying out this effort,
the law requests that NIH seek put to
identify ways to ensure regulations and
policies are not inconsistent,
overlapping, or unnecessarily
duplicative.
In carrying out the review, NIH
OLAW, USDA, and FDA are currently
reviewing the following reports and
surveys:
• Reforming Animal Research
Regulations: Workshop
Recommendations to Reduce Regulatory
Burden, 2017, Report of an April 17,
2017 workshop organized by Federation
of American Societies for Experimental
Biology (FASEB), the Association of
American Medical Colleges, and the
Council on Governmental Relations,
with support from the National
Association for Biomedical Research,
https://www.faseb.org/Portals/2/PDFs/
opa/2017/FASEB-Animal-RegulatoryReport-October2017.pdf.
• Optimizing the Nation’s Investment
in Academic Research: A New
Regulatory Framework for the 21st
Century, 2016, National Academies,
https://www.nap.edu/catalog/21824/
optimizing-the-nations-investment-inacademic-research-a-new-regulatory.
• Reducing Investigators’
Administrative Workload for Federally
Funded Research, 2014, National
Science Board, National Science
Foundation, https://www.nsf.gov/pubs/
2014/nsb1418/nsb1418.pdf.
• 2012 Faculty Workload Survey
Research Report, 2014, Federal
Demonstration Partnership (FDP),
https://sites.nationalacademies.org/cs/
groups/pgasite/documents/webpage/
pga_087667.pdf.
• Findings of the FASEB Survey on
Administrative Burden, 2013, FASEB,
https://www.faseb.org/portals/2/pdfs/
opa/6.7.13%20FASEB%20NSB%20
Survey%20findings.pdf.
We are seeking the input of interested
stakeholders concerning proposed
actions that the agencies have identified
to improve coordination and
harmonization of regulations and
policies. The responses received will
provide critical information for final
recommendations and implementation.
II. Information Requested
Input is sought on each of the
following proposed actions that the
agencies are considering:
1. Allow investigators to submit
protocols for continuing review using a
risk-based methodology.
2. Allow annual reporting to OLAW
and USDA on the same reporting
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11221
schedule and as a single report through
a shared portal.
3. Harmonize the guidance from NIH
and USDA to reduce duplicative
considerations of alternatives to painful
and distressful procedures.
4. Provide a minimum 60-day
comment period for new OLAW policy
guidance.
5. Other approaches not previously
mentioned.
Feedback is sought on whether the
following tools and resources are or
would be helpful for reducing burden
on investigators:
1. Encourage the use of sections of the
AAALAC International program
description in applicable parts of the
OLAW Animal Welfare Assurance, for
institutions accredited by AAALAC
International.
2. Encourage the use of the FDP
Compliance Unit Standard Procedures
as a repository of best practices for
standard procedures used for research
with animals.
3. Encourage the use of the IACUC
Administrators Association repository
of best practices by IACUCs.
4. Encourage the use of new or
existing tools to streamline protocol
review through use of designated
member review (DMR), DMR
subsequent to full committee review,
and/or Veterinary Verification and
Consultation.
5. Expanded IACUC training activities
that focus on reducing burden on
investigators.
Dated: March 8, 2018.
Francis S. Collins,
Director, National Institutes of Health.
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute of Arthritis and
Musculoskeletal and Skin Diseases;
Notice of Closed Meeting
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended, 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
E:\FR\FM\14MRN1.SGM
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11222
Federal Register / Vol. 83, No. 50 / Wednesday, March 14, 2018 / Notices
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: Arthritis and
Musculoskeletal and Skin Diseases Special
Emphasis Panel; AMSC Members Conflict
Review Meeting.
Date: March 15–16, 2018.
Time: 8:00 a.m. to 5:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institute of Arthritis,
Musculoskeletal and Skin Diseases, NIH,
Conference Room 803, 6711 Democracy
Boulevard, Bethesda, MD 20817.
Contact Person: Xincheng Zheng, MD,
Ph.D., Scientific Review Officer, Scientific
Review Branch, National Institute of
Arthritis, Musculoskeletal and Skin Diseases,
NIH, 6701 Democracy Boulevard, Suite 820,
Bethesda, MD 20892, 301–451–4838,
xincheng.zheng@nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.846, Arthritis,
Musculoskeletal and Skin Diseases Research,
National Institutes of Health, HHS)
Dated: March 7, 2018.
Sylvia L. Neal,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2018–05084 Filed 3–13–18; 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 Meetings
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Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended, 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: Center for Scientific
Review Special Emphasis Panel; Myalgic
Encephalomyelitis/Chronic Fatigue
Syndrome.
Date: April 4, 2018.
Time: 11:00 a.m. to 6:00 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: Jana Drgonova, Ph.D.,
Scientific Review Officer, Center for
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18:17 Mar 13, 2018
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Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 5213,
Bethesda, MD 20892, 301–827–2549,
jdrgonova@mail.nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; Pediatric
Immunotherapy Discovery and Development
Network (PI–DDN) U54 Review.
Date: April 5, 2018.
Time: 8:00 a.m. to 5:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: Bethesda Marriott, 5151 Pooks Hill
Road, Bethesda, MD 20814.
Contact Person: Lawrence Ka-Yun Ng,
Ph.D., Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 6152,
MSC 7804, Bethesda, MD 20892, 301–435–
1719, ngkl@csr.nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; Member
Conflict: Myocardial Ischemia and Heart
Failure Member Conflicts.
Date: April 5, 2018.
Time: 9:00 a.m. to 1:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 6701
Rockledge Drive, Bethesda, MD 20892
(Virtual Meeting).
Contact Person: Margaret Chandler, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 4126,
MSC 7814, Bethesda, MD 20892, (301)
435–1743, margaret.chandler@nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; Member
Conflicts: Chemistry.
Date: April 5, 2018.
Time: 10:00 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: Mike Radtke, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 4176,
MSC 7806, Bethesda, MD 20892, 301–435–
1728, radtkem@csr.nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; Molecular
Genetics.
Date: April 5, 2018.
Time: 1:00 p.m. to 6:00 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: Ronald Adkins, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 2206,
MSC 7890, Bethesda, MD 20892, 301–435–
4511, ronald.adkins@nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; Member
Conflict: Studies in Genetics.
Date: April 5, 2018.
Time: 1:00 p.m. to 5:00 p.m.
Agenda: To review and evaluate grant
applications.
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Place: National Institutes of Health, 6701
Rockledge Drive, Bethesda, MD 20892
(Telephone Conference Call).
Contact Person: Baishali Maskeri, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 2022,
Bethesda, MD 20892, 301–827–2864,
maskerib@mail.nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; Member
Conflict: Biophysics.
Date: April 5, 2018.
Time: 1:00 p.m. to 4:00 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: Richard D Crosland, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 4190,
MSC 7850, Bethesda, MD 20892, 301–694–
7084, crosland@nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; Member
Conflict: Cell Biology and Cellular Signaling,
Interactions, and Migration.
Date: April 5, 2018.
Time: 1:00 p.m. to 4:00 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: Thomas Beres, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Rm. 5201,
MSC 7840, Bethesda, MD 20892, 301–435–
1175, berestm@mail.nih.gov.
(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: March 8, 2018.
David Clary,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2018–05082 Filed 3–13–18; 8:45 am]
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DEPARTMENT OF HOMELAND
SECURITY
Federal Emergency Management
Agency
[Docket ID: FEMA–2018–0016; OMB No.
1660–0139]
Agency Information Collection
Activities: Proposed Collection;
Comment Request; Ready PSA
Campaign Creative Testing Research
Federal Emergency
Management Agency, DHS.
AGENCY:
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[Federal Register Volume 83, Number 50 (Wednesday, March 14, 2018)]
[Notices]
[Pages 11221-11222]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-05084]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
National Institute of Arthritis and Musculoskeletal and Skin
Diseases; Notice of Closed Meeting
Pursuant to section 10(d) of the Federal Advisory Committee Act, as
amended, 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
[[Page 11222]]
applications, the disclosure of which would constitute a clearly
unwarranted invasion of personal privacy.
Name of Committee: Arthritis and Musculoskeletal and Skin
Diseases Special Emphasis Panel; AMSC Members Conflict Review
Meeting.
Date: March 15-16, 2018.
Time: 8:00 a.m. to 5:00 p.m.
Agenda: To review and evaluate grant applications.
Place: National Institute of Arthritis, Musculoskeletal and Skin
Diseases, NIH, Conference Room 803, 6711 Democracy Boulevard,
Bethesda, MD 20817.
Contact Person: Xincheng Zheng, MD, Ph.D., Scientific Review
Officer, Scientific Review Branch, National Institute of Arthritis,
Musculoskeletal and Skin Diseases, NIH, 6701 Democracy Boulevard,
Suite 820, Bethesda, MD 20892, 301-451-4838, [email protected].
(Catalogue of Federal Domestic Assistance Program Nos. 93.846,
Arthritis, Musculoskeletal and Skin Diseases Research, National
Institutes of Health, HHS)
Dated: March 7, 2018.
Sylvia L. Neal,
Program Analyst, Office of Federal Advisory Committee Policy.
[FR Doc. 2018-05084 Filed 3-13-18; 8:45 am]
BILLING CODE 4140-01-P
