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Issued by

OFFICE OF THE DIRECTOR, NATIONAL INSTITUTES OF HEALTH (OD)

Purpose

This Request for Information (RFI) seeks input from domestic and foreign institutions with an approved Animal Welfare Assurance on the reporting of animal numbers. The Office of Laboratory Animal Welfare (OLAW) seeks input on feasibility, current capabilities, expected benefits, and expected burdens associated with yearly reporting of the number of live, vertebrate animals subject to and defined by the Public Health Service Policy on Humane Care and Use of Laboratory Animals (PHS Policy). This would bring reporting standards for laboratory animals not covered by the Animal Welfare Act (AWA) in line with existing reporting for AWA covered species, to include animal numbers and USDA pain and distress categories as defined in the Animal Welfare Act Regulations.

Background

OLAW oversees animal activities of Assured institutions by the authority of the Health Research Extension Act of 1985 and the PHS Policy. Through memoranda of understanding (MOUs), OLAW also has oversight authority for animal activities supported or conducted by other federal agencies. At the time of this RFI, these include the National Science Foundation (NSF), the National Aeronautics and Space Administration (NASA), and the United States Department of Veterans Affairs (VA). For the current list of agencies having an MOU with NIH for oversight of animal activities, see the OLAW website.

The PHS Policy defines animal as "[a]ny live, vertebrate animal used or intended for use in research, research training, experimentation, or biological testing or for related purposes." (PHS Policy III.A.)

Currently, animal inventory is reported to OLAW in the Domestic Animal Welfare Assurance. Institutions are required to provide "the gross square footage of each animal facility (including satellite facilities), the species housed therein, and the average daily inventory, by species, of animals in each facility...." (PHS Policy. IV.A.1.h) Animal numbers are currently not required in the Annual Report to OLAW. (PHS Policy IV.F.1)

OLAW is soliciting feedback regarding feasibility for institutions with Domestic and Foreign Assurances to report annual animal numbers by species and pain and distress categories. The requirement for animal numbers included in Domestic Assurances under the PHS Policy. IV.A.1.h would remain unchanged. Note that the proposed tracking and reporting by the institution would be for cumulative annual numbers by species, which may be estimated in select instances (e.g. fish, if necessary), and would include all live vertebrate animal species as defined by the PHS Policy such as mice of the Genus Mus, rats of the genus Rattus, fish, frogs, etc. The reporting requirement would exclude animals used in field investigations as defined in the Guide for the Care and Use of Laboratory Animals (Guide). The current (8^th Edition) of the Guide defines field investigations as "the observation or use of nondomesticated vertebrate species under field conditions." (Guide p. 32)

Annual reports by institutions would be made publicly available online.

90-day Comment Period

Comments on this Notice must be received no later than December 21, 2026.

Information Requested

Please include the information below in your comments for the proposed yearly reporting of the numbers of all live vertebrate animals as defined by the PHS Policy using the USDA pain and distress categories in the Animal Welfare Act Regulations: 

1. methods currently used, including software, for compiling institutional animal numbers, including pain and distress categories;
2. information on whether annual institutional animal tracking and reporting is currently being performed for internal (e.g. per diem determination) or external (e.g. oversight agencies) purposes, and what information is included in those reports;
3. feasibility of the proposed reporting, as well as any aspects of the reporting identified as not feasible;
4. a realistic, estimated timeline to implement such reporting;
5. institutional resources required (e.g., minimum budget, additional staff, etc.) to develop and implement the proposed reporting;
6. any anticipated benefits or drawbacks from implementing the proposed reporting;
7. information on whether the proposed reporting may create additional institutional work/burden, both direct (e.g. tracking, software, time, personnel, training etc.) and indirect (e.g. publicity, security concerns, etc.), where applicable;
8. any additional opinions or suggestions on this proposed change.

How to Submit a Response

All responses to this RFI must be submitted electronically on the RFI webpage by December 21, 2026, 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 future funding opportunity announcements or policies. 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
Telephone: 301-496-7163
Email: [email protected]