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A recently published report on “Reducing Administrative Burden for Researchers: Animal Care and Use in Research” describes the collective recommendations of a Working Group of Experts convened by the NIH, USDA, and FDA as part of the 21st Century Cures Act. Of particular note are actions recommended to:

  • Clarify OLAW’s guidance on IACUC protocol to grant protocol congruence;
  • Emphasize that OLAW and USDA guidance and policies are recommendations and best practices (they are not statutory);
  • Encourage the use of Designated Member Review for low-risk activities;
  • Clarify activities that may be exempt from IACUC review;
  • Ask the FDA and NIH to review and update current guidance on the use of non-pharmaceutical grade compounds;
  • Direct the USDA to consider initiating formal rulemaking to align its current requirement for annual review of protocols by the IACUC with the NIH’s triennial requirement;
  • Have OLAW review its guidance on institutional reporting of noncompliance including the current requirement to include the associated grant number; and
  • Direct the USDA and OLAW to develop options for harmonizing requirements with the DoD and the VA.

It is important to note that many of these recommendations will be open for public comment and may or may not be put into place. For full details on the recommendations and associated background, follow the report link.

Reducing Administrative Burden for Researchers: Animal Care and Use in Research

Federal Notice, NOT-OD-19-136

CITI Program’s Animal Care and Use Catalog

December 2019 Newsletter