July 22, 2020
Office of The Director, National Institutes of Health (OD)
Through this Request for Information (RFI), the NIH Office of Laboratory Animal Welfare (OLAW) is seeking input on flexibilities available for conducting semiannual animal facility inspections.
OLAW oversees Public Health Service (PHS)-funded animal activities by the authority of the Health Research Extension Act of 1985 (HREA) and the PHS Policy on Humane Care and Use of Laboratory Animals (Policy). The HREA requires that each animal care committee of a research entity review the care and treatment of animals in all animal study areas and facilities of the research entity at least semiannually to evaluate compliance with applicable guidelines. The PHS Policy also requires that Institutional Animal Care and Use Committees (IACUCs) review the institution’s program for humane care and use of animals and inspect all of the institution’s animal facilities, including satellite facilities, at least once every six months using the Guide for the Care and Use of Laboratory Animals (Guide) as a basis for the evaluation. Animal facilities include all buildings, rooms, areas, enclosures, or vehicles, including satellite facilities, used for animal confinement, transport, maintenance, breeding, or experiments inclusive of surgical manipulation.
Semiannual inspections have been identified as an area in which there is an opportunity to reduce administrative burden in the report Reducing Administrative Burden for Researchers: Animal Care and Use in Research.
Here we highlight flexibilities that are available to IACUCs for conducting semiannual inspections of their animal facilities. Additional details and resources may be found at Semiannual Facility Inspections. These flexibilities may be employed alone or in combination to meet the individual needs and circumstances of each institution.
The NIH is seeking input on the flexibilities described in items 1 – 10 below that are available to IACUCs for conducting semiannual inspections of their animal facilities.
Flexibilities for Conducting Semiannual Inspections
IACUCs may consider the following flexibilities when conducting semiannual animal facility inspections:
The next IACUC inspection must be no later than six months plus 30 days from when the AAALAC site visit occurred.
The USDA Animal and Plant Health Inspection Service has reviewed and concurs with the guidance provided in this Notice.
How to Submit a Response
Comments must be submitted electronically on the RFI webpage. Comments must be received on or before October 22, 2020, at 11:59 PM 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.
Office of Laboratory Animal Welfare