Update to the Current OLAW Guidance Disclaimer RFI

APS’ response to a request for information from the National Institutes of Health Office of Laboratory Animal Welfare (OLAW) on updated language in the OLAW Guidance Disclaimer statement as part of a wider effort to fulfill obligations under the 21st Century Cures Act to reduce regulatory and administrative burden.

The American Physiological Society is grateful for the opportunity to comment on NOT-OD-23-157, Request for Information on an Update to the Current OLAW Guidance Disclaimer. We appreciate the changes and updates made to the OLAW Guidance Disclaimer. APS appreciates the removal of phrases such as “recommendations”, “best practices,” “advice,” and “current thinking” from the OLAW Guidance Disclaimer. These phrases often led to the incorrect understanding that OLAW Guidance is binding language. OLAW Guidance should not be used to make more restrictive requirements than existing regulation and legislation. Though we appreciate the removal of confusing terminology in the Guidance Disclaimer, the addition of the phrase “expands upon” reintroduces that confusion. This phrase could be interpreted to mean that OLAW Guidance is a binding expansion of statutory and regulatory requirements, instead of just one interpretation for meeting the outcome-based requirements in the PHS Policy.