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Issued by

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

Purpose

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.

Background

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.

Information Requested

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:

1. The IACUC has discretion to determine the best means of conducting the facility inspections. This includes using qualified individuals as ad hoc consultants. For areas housing non-Animal Welfare Act (AWA)-regulated species, the IACUC may use as few as one qualified individual to conduct the inspections. However, as is always required for semiannual inspections, no IACUC member should be involuntarily excluded from the inspections, and the IACUC remains responsible for the evaluation and report to the Institutional Official (IO).
   
2. The timing of facility inspections may extend 30 days beyond the six-month interval from the last inspection, provided there is no forward drift of the date from year to year.
   
3. IACUCs may assign specific facility inspections to subcommittees. However, conflicts of interest should be avoided. For example, a committee member or qualified individual may not be the only person assigned to inspect areas for which that person is responsible.
   
4. IACUCs may implement a rolling inspection process, where designated facilities are inspected over time. For example, one area or group of facilities is inspected each month until inspection of all the facilities is completed by the end of the six-month period.
   
5. IACUCs may choose whether the inspections are unannounced or if the animal care and use personnel are notified prior to inspection. Announced visits may facilitate the inspection process by having key personnel available to answer any questions.
   
6. Although the PHS Policy does not specifically identify the review and approval of animal facility standard operating procedures (SOPs) as a requirement for IACUCs, SOPs are frequently a component of an animal care and use program. IACUCs may choose the frequency and method for reviewing animal facility SOPs. All SOPs need not be reviewed every six months but should be reviewed on a regular basis as part of the overall review of the animal care and use program. SOPs referenced in protocols should be evaluated at least once every three years according to the PHS Policy to ensure that they are current and accurate.
   
7. While all of the institution’s animal facilities, including satellite facilities, must be inspected at least once every six months, IACUCs have discretion regarding oversight of areas used for routine weighing, dosing, immunization, or imaging, but should monitor these areas on a regular basis to effectively oversee activities at the institution.
   
8. In some circumstances or for some areas of the program, including field study sites or high containment facilities, the IACUC may find it useful to use videos, photographs, written descriptions, or other appropriate remote methods to conduct the inspection. For example, one person that the IACUC considers qualified may provide a prerecorded or real-time virtual tour to IACUC members for areas housing non-AWA regulated species.
   
9. IACUCs may use an AAALAC accreditation site visit as a semiannual inspection providing it meets the PHS and AWA (where applicable) requirements. All IACUC members are to be informed of the proposed semiannual facility inspection so as to have sufficient time to request participation, and no IACUC member wishing to participate in the inspection is excluded. The semiannual report which is submitted to the IO must be signed by a majority of the IACUC members and include the following:
   1. A description of the nature and extent of the institution’s adherence to the PHS Policy, the Guide, and the Animal Welfare Act;
   2. A description of and reason for each departure identified;
   3. Deficiencies distinguished as minor or significant with a reasonable plan and schedule for correcting each deficiency; and
   4. Any minority views.

   The next IACUC inspection must be no later than six months plus 30 days from when the AAALAC site visit occurred.

10. OLAW has developed a checklist to help IACUCs conduct the Semiannual Program Review and Facility Inspection. Institutions are not required to use this checklist, and it can be amended as necessary to reflect the institution’s program and needs.

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.

Inquiries

Please direct all inquiries to:

Office of Laboratory Animal Welfare
Telephone: 301-496-7163
Email: olaw@mail.nih.gov