Request for Information (RFI): Input on Draft Report from Working Group on Reducing Administrative Burden to Researchers for Animal Care and Use in Research

The National Institutes of Health (NIH) Office of Laboratory Animal Welfare (OLAW) is seeking 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. The RFI is a coordinated effort of the Director of NIH 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 (P.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 input to identify ways to ensure regulations and policies are not inconsistent, overlapping, or unnecessarily duplicative.

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 US Congress.

Information Requested

Input is sought on the draft report of the Working Group 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 Reducing Administrative Burden for Researchers: Animal Care and Use in Research (PDF).

For more information, see NIH Guide Notice, NOT-OD-19-028, and Federal Register Notice 2018-26557.

To ensure consideration, responses must be submitted by: February 20, 2019 11:59:59 PM EDT

( * = Required fields)

Information Requested

Name

Email Address

Name of Organization

Type of Organization

City and State

Enter any input you may have on the draft report

Note that comments may be publically available. Personally identifiable information (except organizational affiliations and addresses) will be removed by NIH prior to making comments publically available. Please do not submit confidential business information.

Notes

Collection of this information is authorized under 5 U.S.C. 301; 44 U.S.C. 3101. The primary use of this form is to seek input from the public on the recommendations in the draft report of the Working Group with respect to research with laboratory animals as required by the 21^st Century Cures Act, Section 2034(d). This information will be used by staff of the NIH, its contractors and others, for the purpose of reviewing, collating or analyzing the public’s concerns and determining clarifications on implementation. Submission of this information is voluntary. By providing comments, you are consenting to their consideration and use by the NIH. Comments received before the close of the comment period may be made available on the NIH website. NIH will not post comments that are not related to the requirements of the 21^st Century Cures Act, Section 2034(d) or that NIH has determined as inappropriate or offensive. Personally identifiable information (except for organizational affiliations and addresses) will be removed by NIH prior to making comments publicly available. Please do not submit confidential business information.

If you have any questions regarding the submission of your comments, please email olaw@od.nih.gov.