The National Institutes of Health (NIH) Office of Laboratory Animal Welfare (OLAW) released its “Request for Information (RFI) on Clarifying the Reporting Requirements for Departures from the Guide for the Care and Use of Laboratory Animals” (NOT-OD-21-161) in July of this year. The response deadline just passed as of November 1, 2021.
To no surprise, this clarifying guidance has been issued as a result of the 21st Century Cures Act final report, Reducing Administrative Burden for Researchers: Animal Care and Use in Research.1 We’ve talked about the 21st Century Cures Act on several occasions as it is already proving to have an impact on the industry.
What is this Notice For?
This notice is in response to the recommendation to eliminate “the Public Health Service (PHS) requirement for compliance with the Guide” as departures from the Guide were one of the areas identified as a good place to reduce administrative burden.2 As this recommendation may be extreme, it was further recommended by the public, including by the Federation of American Societies for Experimental Biology (FASEB)3, that deviations from ‘should’ statements [in the Guide] no longer be considered departures and therefore, not be reportable [to the Institutional Official (IO) and OLAW].”2 OLAW’s response to this recommendation in the final report on the 21st Century Cures Act and in the RFI, however, is expected that the Guide is an essential resource and critical to ensuring “high-quality research and humane animal care and use.”2
Important Clarifications
As a result, NOT-OD-21-161 includes a series of clarifications on, not changes to, the reporting requirements and what is considered a departure from the Guide.
Three main areas are covered:
deviations for which reporting to the IO in the semiannual report is not required;
deviations for which reporting to the IO in the semiannual report is required; and
deviations for which reporting to OLAW is required.
In our opinion, the most valuable of these three areas are the deviations for which reporting to the IO in the semiannual report is not required. We recommend that Institutional Animal Care and Use Committees (IACUC) review this information carefully to ensure that no unnecessary administrative or regulatory burden is being experienced.
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