NOT-OD-25-145: Notice of an Update to the OLAW Guidance Disclaimer

Notice of an Update to the OLAW Guidance Disclaimer

Notice Number:

NOT-OD-25-145

Key Dates

Release Date:

August 27, 2025

Related Announcements

July 11, 2023 – Request for Information (RFI) on an Update to the Current OLAW Guidance Disclaimer.  See Notice NOT-OD-23-157.

Issued by

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

Purpose

Purpose

The purpose of this notice is to provide an update to the National Institutes of Health (NIH) Office of Laboratory Animal Welfare (OLAW) guidance disclaimer. The Health Research Extension Act of 1985, Public Law 99-158, Sec. 495, Animals in Research, (HREA) provides the statutory mandate for the Public Health Service (PHS) Policy on Humane Care and Use of Laboratory Animals (Policy).

Background

The PHS Policy applies to all PHS-conducted or supported activities involving live, vertebrate animals used or intended for use in research, research training, experimentation, or biological testing or for related purposes. At the time of this notice, PHS components subject to PHS Policy include 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, the PHS Policy also currently applies to animal activities funded or supported by the National Aeronautics and Space Administration (NASA), National Science Foundation (NSF), and Department of Veterans Affairs (VA).

OLAW’s mission to provide guidance and interpretation of the PHS Policy is consistent with PHS Policy Section V. which describes OLAW’s responsibilities for “the general administration and coordination of” the PHS Policy, including “advising awarding units and awardee institutions concerning the implementation of this [PHS] Policy.”

The PHS Policy requires compliance with the following documents to ensure the humane care and use of animals in funded or supported activities:

The U.S. Government Principles for the Utilization and Care of Vertebrate Animals Used in Testing, Research, and Training, which provides an ethical framework for conducting research (PHS Policy Section I)
The Guide for the Care and Use of Laboratory Animals (Guide) as a basis for developing and implementing an institutional program for activities involving animals (PHS Policy Section IV.A.1.)
The American Veterinary Medical Association (AVMA) Guidelines for the Euthanasia of Animals, unless a deviation is justified for scientific reasons (PHS Policy Section IV.C.1.g.)

When applicable, the PHS Policy Section II., also requires compliance with:

The Animal Welfare Act and other federal statutes and regulations relating to animals
State or local laws or regulations which impose more stringent standards for the care and use of laboratory animals

Additionally, PHS Policy Section II. indicates that institutions in foreign countries receiving PHS support for activities involving animals shall comply with PHS Policy or provide evidence that acceptable standards for the humane care and use of the animals will be met.

In 2016, the 21^st Century Cures Act, Public Law 114-255, Section 2034(d), directed the NIH, in collaboration with the United States Department of Agriculture (USDA), and the Food and Drug Administration (FDA), 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 administrative burden on investigators while maintaining the integrity and credibility of research findings and protection of research animals. The NIH, USDA, and FDA convened a Working Group of federal subject matter experts to identify inconsistent, overlapping, and unnecessarily duplicative regulations and policies and prepare a report of their recommendations. One action item identified by the research community and described in the Working Group’s report, Reducing Administrative Burden for Researchers: Animal Care and Use in Research, included a review and update of the current OLAW guidance disclaimer. According to this report, the revised disclaimer should emphasize that “unless specific statutory or regulatory requirements are cited, the guidance should be viewed as recommendations in that an institution may use an alternative approach if the approach satisfies the requirements of the PHS Policy.”

The Department of Justice’s 1-19.000 Principles for Issuance and Use of Guidance Documents defines a guidance document as “a statement of general applicability issued by an agency to inform the public of its policies or legal interpretations.” Guidance documents do not have the force and effect of law but can be interpretive with the intent to advise the public of how the agency understands, and is likely to apply, its binding statutes and legislative rules.

OLAW published a Request for Information (RFI) on an Update to the Current OLAW Guidance Disclaimer, NOT-OD-23-157, on July 11, 2023, with public comments due on October 22, 2023. OLAW received seven comments in response and carefully considered each comment. To provide further clarity, terms that could be misinterpreted (i.e., “current thinking” and “best practices”) were excluded from the guidance disclaimer to emphasize matters of core importance to animal welfare as identified in statutory language.

Compliance with the PHS Policy mandates that institutions use the Guide as a basis for developing and implementing an animal care and use program. The Guide recognizes evidence-based performance standards as alternative approaches to allow flexibilities when adhering to regulatory standards. Although OLAW encourages the cooperative application of diverse expertise to develop performance standards, there remains an expectation for outcomes to comply with the PHS Policy and OLAW has the authority to evaluate if the alternate approaches satisfy the requirements of the PHS Policy. The revised OLAW guidance disclaimer endorses the use of evidence-based performance standards, as well as statutory requirements.

Updated OLAW 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.

Inquiries

Please direct all inquiries to:

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