21st Century Cures Act – Animal Care and Use in Research

NIH in collaboration with USDA APHIS Animal Care (AC) and FDA is conducting a review of applicable regulations and policies for the care and use of laboratory animals and will make revisions, as appropriate, to reduce administrative burden on investigators while maintaining the integrity and credibility of research findings and protection of research animals as required by the 21st Century Cures Act, Section 2034 (d).

In carrying out this effort, the agencies are reviewing numerous reports and surveys that have been published over the last several years addressing the topic of administrative and investigator burden. In addition, the agencies are seeking information to improve the coordination of regulations and policies with respect to research with laboratory animals through various stakeholder listening sessions and a future Request for Information. Public input concerning possible actions that the agencies should consider to improve coordination and harmonization of regulations and policies will provide valuable information for consideration by the agencies.

Listening Session: January 9, 2018 – Washington, DC

Representatives from NIH OLAW, APHIS AC and FDA held a public listening session at the Hyatt Regency Capitol Hill immediately following the Federal Demonstration Partnership (FDP) sessions on January 9th. Provided here are the introductory slides (PDF) and list of registered speakers with their written comments, if provided.

Speakers and Comments 

Listening Session: January 29, 2018

Representatives from NIH OLAW, APHIS AC and FDA joined the AAALAC International Council Meeting for a listening session on January 29th. Introductory slides and a summary of the discussion are pending.

Upcoming Listening Sessions:


Request for Information:

Federal Register Notice 2018-05173 and NIH Guide Notice NOT-OD-18-152: Request for Information is open for public comment for a period of 90 days. Comments must be submitted electronically at https://grants.nih.gov/grants/rfi/rfi.cfm?ID=71 and must be received by June 12, 2018 to ensure consideration.


Call (301-496-7163) or e-mail (olaw@mail.nih.gov) OLAW for answers to your questions.