Skip to Content

We invite you to try out our new beta eCFR site at We’ve made big changes to make the eCFR easier to use. Be sure to leave feedback using the 'Help' button on the bottom right of each page!


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

Document Details

Information about this document as published in the Federal Register.

Document Statistics
Document page views are updated periodically throughout the day and are cumulative counts for this document. Counts are subject to sampling, reprocessing and revision (up or down) throughout the day.
Published Document

This document has been published in the Federal Register. Use the PDF linked in the document sidebar for the official electronic format.

Start Preamble


National Institutes of Health, HHS.




The National Institutes of Health (NIH) is announcing the Start Printed Page 45160publication 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.

Start Further Info


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:

End Further Info End Preamble Start Supplemental 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​sites/​default/​files/​21CCA_​final_​report.pdf.

Start Signature

Dated: August 21, 2019.

Francis S. Collins,

Director, National Institutes of Health.

End Signature End Supplemental Information

[FR Doc. 2019-18611 Filed 8-27-19; 8:45 am]