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NOT-OD-05-034 - Guidance on Prompt Reporting to OLAW Under the PHS Policy on Humane Care and Use of Laboratory Animals

Issued by

Office of The Director, National Institutes of Health (OD)

Purpose

Through this Request for Information (RFI), the National Institutes of Health (NIH) Office of Laboratory Animal Welfare (OLAW) is seeking input on updates to the current Guidance on Prompt Reporting to OLAW Under the PHS Policy on Humane Care and Use of Laboratory Animals (NOT-OD-05-034). The updated guidance seeks to reduce administrative burden by clarifying the reporting requirements, without negatively impacting the accountability and transparency of the process.

Background

The 21^st Century Cures Act, section 2034(d), directed the NIH to conduct a review of applicable regulations and policies for the care and use of laboratory animals and to make revisions, as appropriate, to reduce the administrative burden on investigators while maintaining the integrity and credibility of research findings and protection of research animals. One of the actions identified in the report Reducing Administrative Burden for Researchers: Animal Care and Use in Research as part of the 21^st Century Cures Act is for OLAW to review and revise the current guidance on reporting requirements in NIH Guide Notice NOT-OD-05-034 by:

• Refining and updating the information to be reported,
• Providing additional examples of situations not normally reported,
• Refining examples of reportable situations, and
• Clarifying the reporting timeframe.

The NIH OLAW oversees Public Health Service (PHS)-funded animal activities by the authority of the Health Research Extension Act of 1985 and the PHS Policy on Humane Care and Use of Laboratory Animals (Policy). The PHS Policy applies to research conducted or supported by several PHS agencies including the NIH, Biomedical Advanced Research and Development Authority (BARDA), Centers for Disease Control and Prevention (CDC), and Food and Drug Administration (FDA). Through memoranda of understanding, this requirement also applies to activities conducted or supported by the National Aeronautics and Space Administration (NASA), National Science Foundation (NSF), and Department of Veterans Affairs (VA).

The PHS Policy IV.F.3. requires: “The IACUC, through the Institutional Official, shall promptly provide OLAW with a full explanation of the circumstances and actions taken with respect to:

1. any serious or continuing noncompliance with this Policy;
2. any serious deviation from the provisions of the Guide; or
3. any suspension of an activity by the IACUC.”

After a comprehensive review, OLAW has determined that certain guidance on reporting requirements in NIH Guide Notice NOT-OD-05-034 is still applicable and will remain unchanged, specifically with reference to the:

• List of examples of reportable situations 
• Time frame for reporting

If in doubt about whether an incident must be reported, institutions are encouraged to call OLAW to discuss the details and receive guidance on the specific incident.

Information Requested

The NIH is seeking input on the following proposed changes to OLAW’s current prompt reporting guidance NOT-OD-05-034:

Information to be reported:

• Award numbers for NSF awards must be included with noncompliance reports. PHS award numbers need not be included with reports of noncompliance unless requested by OLAW or if determined to be applicable by the reporting institution. However, the funding source (PHS, NASA, VA) must be identified for all reports to OLAW.

Additional examples of situations not normally reported:

• Minor animal injury by conspecifics during social housing when proper introduction and subsequent ongoing monitoring occurred.
  • Exception: Euthanasia of an animal, or injury requiring medical treatment and extended or permanent separation from the group must be reported.
• Expired medications identified after the expiration date, but not administered to animals after expiration.
• Brief and infrequent excursions of low environmental relative humidity, or minor temperature fluctuations, when no animal health or welfare issues resulted; and a program of required daily monitoring was in place.
• Any isolated noncompliant incident involving animal activities not supported by the PHS, NSF, NASA, or VA, and the incident is not part of a functional, programmatic, or physical area that could affect activities supported by these agencies. 
  •  Exception: If the institution’s Animal Welfare Assurance states that all incidents will be reported regardless of funding source, the incident must be reported. 

How to Submit a Response: All responses to this RFI must be submitted electronically on the RFI webpage by May 5, 2023, at 11:59 EDT. The comments may be made available on the OLAW website.

Responses to this RFI are voluntary and may be submitted anonymously. Please do not include any personally identifiable or other information that you do not wish to make public. Proprietary, classified, confidential, or sensitive information should not be included in responses. The Government will use the information submitted in response to this RFI at its discretion. The Government reserves the right to use any submitted information on public websites, in reports, in summaries of the state of the science, in any possible resultant solicitation(s), grant(s), or cooperative agreement(s), or in the development of future funding opportunity announcements. This RFI is for informational and planning purposes only and is not a solicitation for applications or an obligation on the part of the Government to provide support for any ideas identified in response to it. Please note that the Government will not pay for the preparation of any information submitted or for use of that information.

Inquiries

Please direct all inquiries to:

Office of Laboratory Animal Welfare (OLAW)
Telephone: 301-496-7163
Email: [email protected]