8/27/25 OLAW News: OLAW Publishes Guide Notice on the OLAW Disclaimer

08/27/2025

In this issue: 

  • OLAW Publishes Guide Notice on the OLAW Disclaimer 

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OLAW Publishes Guide Notice on the OLAW Disclaimer 

In response to the 21st Century Cures Act, OLAW has reviewed and revised its guidance disclaimer after the public comments received in response to the RFI NOT-OD-23-157. More information can be found in the updated Guide Notice NOT-OD-25-145. The text was shortened and clarified as follows: 


Old Guidance Disclaimer (retired): OLAW develops, monitors, and exercises compliance oversight relative to the Public Health Service (PHS) Policy on Humane Care and Use of Laboratory Animals (Policy). One of OLAW's primary functions is to advise awarding units and awardee institutions concerning the implementation of the PHS Policy. OLAW often provides this advice by responding to policy-related questions submitted by such units and institutions. The following Notices provide guidance that represents OLAW's current thinking on these topics. This guidance is based on OLAW's experience with the subject matter and draws on best practices followed by the biomedical community regarding the use of research animals. Unless specific statutory or regulatory requirements are cited, the Notices should be viewed as recommendations in that an institution may use an alternative approach if the approach satisfies the requirements of the PHS Policy. 


Updated Guidance Disclaimer: A guidance document is a statement of general applicability issued by an agency to inform the public of its policies. OLAW is responsible for advising Assured institutions concerning the implementation of the Public Health Service Policy on Humane Care and Use of Laboratory Animals (PHS Policy Section V.A.3.). OLAW’s oversight authority is derived from statutory and regulatory requirements of Public Law 99-158, Sec. 495, and the PHS Policy. Information provided that is not contained within specific statutory or regulatory requirements represents OLAW’s interpretations for meeting the outcome-based requirements in the PHS Policy. However, an institution may use an alternative approach if the approach satisfies the requirements of the Policy without compromising animal welfare.
  

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