[Federal Register Volume 84, Number 167 (Wednesday, August 28, 2019)]
[Notices]
[Pages 45159-45160]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-18611]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Laboratory Animal Welfare: Report on Reducing Administrative 
Burden for Researchers: Animal Care and Use in Research

AGENCY: National Institutes of Health, HHS.

ACTION: Notice.

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SUMMARY: The National Institutes of Health (NIH) is announcing the

[[Page 45160]]

publication of Reducing Administrative Burden for Researchers: Animal 
Care and Use in Research, a report by the NIH, the United States 
Department of Agriculture (USDA), and the Food and Drug Administration 
(FDA). The report describes the recommendations of the 21st Century 
Cures Act, Section 2034(d), Working Group and decisions of the 
agencies.

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

    Title II, Section 2034(d) of the 21st Century Cures Act (Pub. L. 
114-255) was enacted December 13, 2016, and requires the NIH in 
collaboration with USDA and FDA to complete a review of applicable 
regulations and policies for the care and use of laboratory animals and 
to make revisions, as appropriate, to reduce administrative burden on 
investigators while maintaining the integrity and credibility of 
research findings and protection of research animals. The Act instructs 
NIH to: (1) Seek the input of experts, if appropriate; (2) identify 
ways to ensure applicable regulations and policies are not 
inconsistent, overlapping, or unnecessarily duplicative; (3) take steps 
to eliminate or reduce identified inconsistencies, overlap, or 
duplication among such regulations and policies; and (4) take other 
actions, as appropriate, to improve the coordination of regulations and 
policies with respect to research with laboratory animals.
    NIH, USDA, and FDA convened a Working Group of federal subject 
matter experts to identify inconsistent, overlapping, and unnecessarily 
duplicative regulations and policies and prepare a report of their 
recommendations as directed in the 21st Century Cures Act. The report 
on Reducing Administrative Burden for Researchers: Animal Care and Use 
in Research describes the efforts of the Working Group, their 
recommendations, and the decisions of NIH, USDA, and FDA on the 
recommendations.

II. Electronic Access

    The report on Reducing Administrative Burden for Researchers: 
Animal Care and Use in Research is available at https://olaw.nih.gov/sites/default/files/21CCA_final_report.pdf.

    Dated: August 21, 2019.
Francis S. Collins,
Director, National Institutes of Health.
[FR Doc. 2019-18611 Filed 8-27-19; 8:45 am]
BILLING CODE 4140-01-P