Key Dates

Related Announcements

None

Issued by

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

Purpose

The purpose of this Notice is to seek public comment on an update to the current Office of Laboratory Animal Welfare (OLAW) guidance disclaimer.

Background

The Health Research Extension Act of 1985 (HREA), Public Law 99-158, Animals in Research, provides the statutory mandate for the Public Health Service (PHS) Policy on Humane Care and Use of Laboratory Animals (Policy). 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. PHS agencies 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 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 V.A.3. 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 the PHS Policy.

To ensure acceptable standards for the humane care and use of the animals in funded or supported activities, the PHS Policy incorporates by reference:

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

The PHS Policy 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.

The 21st Century Cures Act, Public Law 114-255, Section 2034(d), directed the NIH, in collaboration with the United States Department of Agriculture (USDA) and 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. One action item identified by the research community and described in the report, Reducing Administrative Burden for Researchers: Animal Care and Use in Research, included review of OLAW’s current guidance disclaimer. The proposed revision 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.

Furthermore, 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. The use of performance standards should include performance indices which support scientific objectives while ensuring animal welfare and has associated outcome criteria. OLAW encourages the cooperative application of diverse expertise to develop performance standards, however, there remains an expectation for outcomes based on the requirements in the PHS Policy. OLAW has the authority to evaluate if the alternate approaches satisfy the requirements of the PHS Policy.

Guidance documents, as defined by the Department of Justice’s 1-19.000 Principles for Issuance and Use of Guidance Documents, do not have the force and effect of law and cannot impose any legally binding requirements on constituents. In general, guidance documents:

• can be interpretive with the intent to advise the public of how the agency understands, and are likely to apply, its binding statutes and legislative rules.
• may result in a collection of related statutes, regulations, and other requirements in a single place.
• often convey important information to the public in language that are clearer and more accessible than the underlying statutes and regulations.
• can serve as an important tool to promote transparency, fairness, and efficiency.

For reference, OLAW’s current guidance disclaimer states:

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.

Information Requested

The NIH OLAW is seeking input on the proposed revision to the current OLAW guidance disclaimer.

Proposed Revision to the 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 awardee institutions concerning the implementation of the Public Health Service Policy on Humane Care and Use of Laboratory Animals (PHS Policy V.A.3.). OLAW’s guidance expands upon statutory and regulatory requirements of Public Law 99-158, Sec. 495, and the PHS Policy, including incorporated references. Unless specific statutory or regulatory requirements are cited, the following guidance 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.

How to Submit a Response

All responses to this RFI must be submitted electronically on the RFI webpage by 10/22/2023, at 11:59 ET. 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:

Name: Office of Laboratory Animal Welfare (OLAW)

IC Name: Office of the Directer (OD)

Telephone: 301-496-7163

Email: [email protected]