01/22/2026 OLAW Publishes Guide Notice + Website Updates on Reporting Noncompliance

01/22/2026

In this issue: 

  • Updated Guidance on Prompt Reporting to OLAW under the PHS Policy on Humane Care and Use of Laboratory Animals: NOT-OD-25-148
  • Updated OLAW Web Resources on Reporting Noncompliance 

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Updated Guidance on Prompt Reporting to OLAW under the PHS Policy on Humane Care and Use of Laboratory Animals: NOT-OD-25-148

In response to the 21st Century Cures Act, OLAW has reviewed the guidance in NIH Guide Notice NOT-OD-05-034, “Prompt Reporting to OLAW under the PHS Policy on Humane Care and Use of Laboratory Animals,” to refine and update examples of reportable situations, examples of situations where reporting is not normally required, the time frame for reporting, and the information to be reported. In addition to general edits to improve clarity, six substantive content revisions were made:

  1. Clarification on how reporting requirements apply based the on scope of the institution’s Animal Welfare Assurance. This can be found in the sentence underneath the first paragraph in the section discussing examples of reportable situations.
  2. Clarification on situations that may impact activities subject to the PHS Policy on Humane Care and Use of Laboratory Animals (PHS Policy). This is the final bullet in the section discussing examples of situations where reporting is required.
  3. Addition of examples to the list of situations that normally are not required to be reported to OLAW. These are the final three bulleted items in the section on examples of situations where reporting is not normally required.
  4. Updates to the guidance for inclusion of award numbers and funding sources in reports to OLAW. These updates can be found in the second and third bullets in the section regarding information to be reported.
  5. Clarification on how reporting requirements apply when federal entities have a memorandum of understanding (MOU) with OLAW that applies the PHS Policy to activities they conduct or fund involving live, vertebrate animals used or intended for use in research, research training, experimentation, or biological testing or for related purposes (PHS Policy section III). This is introduced in the background and is clarified in the section on information to be reported.
  6. Clarification that the signature of the Institutional Official (IO) on the final report to OLAW provides verification of compliance with PHS Policy section IV.F.3. This can be found in the in the section on information to be reported.

The revised guidance can be found in NOT-OD-25-148

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Updated OLAW Web Resources on Reporting Noncompliance

In concert with the updated Guide Notice, OLAW has released updated web resources on reporting noncompliance, including helpful charts, tables, and more. These can be found under the 21st Century Cures Act webpages at https://olaw.nih.gov/policies-laws/21st-century-cures-act/Reporting-Noncompliance

This page last updated on: Jan 22, 2026
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