[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]
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