Laboratory Animal Welfare: Coordination and Harmonization of Regulations and Policies, 11221 [2018-05173]
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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
VerDate Sep<11>2014
18:17 Mar 13, 2018
Jkt 244001
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
PO 00000
Frm 00054
Fmt 4703
Sfmt 4703
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.
[FR Doc. 2018–05173 Filed 3–13–18; 8:45 am]
BILLING CODE 4140–01–P
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[Federal Register Volume 83, Number 50 (Wednesday, March 14, 2018)]
[Notices]
[Page 11221]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-05173]
[[Page 11221]]
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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.
-----------------------------------------------------------------------
SUMMARY: 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: [email protected].
SUPPLEMENTARY INFORMATION:
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 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-Regulatory-Report-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-in-academic-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%20Survey%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
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.
[FR Doc. 2018-05173 Filed 3-13-18; 8:45 am]
BILLING CODE 4140-01-P
