COGR Responds to OLAW's Request for Information (RFI) on Clarification of Animal Activities Exempt from PHS Policy Requirements for IACUC Review (NOT-OD-23-119)

COGR submitted comments in response to the National Institutes of Health (NIH) Office of Laboratory Animal Welfare’s (OLAW) Request for Information regarding clarification of animal activities exempt from Public Health Service (PHS) Policy requirements for Institutional Animal Care and Use Committee (IACUC) review. COGR expressed appreciation for the opportunity to comment but noted that the RFI reiterates existing interpretations instead of providing substantive policy revisions or reductions in administrative burden, as directed by the 21st Century Cures Act. The organization recommended that OLAW update its current FAQs rather than reissuing guidance in a new format, emphasizing the need for clearly articulated distinctions between activities exempt from IACUC review under PHS Policy and those subject to other review requirements. COGR provided detailed feedback on specific RFI items, highlighting areas needing clearer language to prevent institutional confusion and improve compliance. For example, it suggested refinements to definitions regarding the purchase of commercially available surgically modified animals and standard animal-based reagents, emphasizing that the classification as "custom" should depend on vendor practice, not production timing. COGR also questioned the inclusion of protocol dual review and activities at foreign institutions, recommending edits or deletions to prevent misinterpretation of exemption status. The letter concluded by reiterating support for improved clarity in OLAW’s guidance to streamline compliance and reduce unnecessary regulatory burden, inviting further dialogue on these issues.