[Federal Register Volume 83, Number 235 (Friday, December 7, 2018)]
[Notices]
[Page 63184]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-26557]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Laboratory Animal Welfare: Draft Report on Recommendations To 
Reduce Administrative Burden on Researchers

AGENCY: National Institutes of Health, HHS.

ACTION: Notice; request for comments.

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SUMMARY: The National Institutes of Health (NIH) is seeking input on 
the draft report by the 21st Century Cures Act Working Group on 
Reducing Administrative Burden to Researchers for Animal Care and Use 
in Research. The draft report 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. It 
describes the proposed actions that the working group has identified 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 working group has identified is open for public comment for a 
period of 60 days. Comments must be submitted electronically at https://grants.nih.gov/grants/rfi/rfi.cfm?ID=83 and must be received by 
February 5, 2019 to ensure consideration.

FOR FURTHER INFORMATION CONTACT: Patricia Brown, Office of Laboratory 
Animal Welfare (OLAW), Office of Extramural Research, National 
Institutes of Health, Suite 2500, 6700B Rockledge Drive, Bethesda, MD 
20892-6910, 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 
seek input on the draft report by the 21st Century Cures Act, Section 
2034(d) Working Group on Reducing Administrative Burden to Researchers 
for Animal Care and Use in Research.
    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. NIH 
OLAW, USDA, and FDA formed a Working Group to: (1) Identify overlapping 
regulations and policies; (2) take steps to reduce such identified 
regulations and policies; and (3) take actions to improve coordination, 
as directed by the U.S. Congress. Input is sought on the draft report 
of the Working Group and others within the federal government and the 
proposed recommendations to reduce the administrative burden associated 
with research activities with laboratory animals while maintaining 
appropriate protections and scientific integrity. The draft report is 
available at https://olaw.nih.gov/sites/default/files/21CCA_draft_report.pdf.

    Dated: November 16, 2018.
Francis S. Collins,
Director, National Institutes of Health.
[FR Doc. 2018-26557 Filed 12-6-18; 8:45 am]
 BILLING CODE 4140-01-P