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NOT-OD-20-169 - Request for Information (RFI) on Encouraging AAALAC International-Accredited Institutions to Use Sections of the AAALAC Program Description in the OLAW Animal Welfare Assurance

Issued by

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

Purpose

This Notice provides information on using sections of the AAALAC International (AAALAC) Program Description (PD) to complete parts of the Office of Laboratory Animal Welfare (OLAW) Domestic Animal Welfare Assurance in response to the 21st Century Cures Act.

Applicable AAALAC PD Sections to Complete Parts of the OLAW Domestic Animal Welfare Assurance

To reduce administrative burden, institutions have the option to use sections of the AAALAC PD when preparing a Domestic Animal Welfare Assurance. Institutions must ensure that all information requested in the Assurance document is provided, including information that is not requested in the AAALAC PD but is required by OLAW.

The relevant sections of the AAALAC PD that institutions may incorporate into the Assurance include:

• Section 2.I.B.2. Post-Approval Monitoring
• Section 2.I.A.2.b. Occupational Health and Safety of Personnel
• Section 2.I.A.2.a. Training, Education, and Continuing Educational Opportunities
• Section 2.I.B.1. The Role of the IACUC

The details of the applicable sections can be found under the Implementation section of OLAW’s 21^st Century Cures Act AAALAC PD webpage.

Background

The 21st Century Cures Act, section 2034(d), directed the NIH 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 the administrative burden on investigators while maintaining the integrity and credibility of research findings and protection of research animals.

One of the actions identified by the Working Group in the report Reducing Administrative Burden for Researchers: Animal Care and Use in Research in response to the 21st Century Cures Act is to encourage AAALAC-accredited institutions to use sections of the AAALAC PD in applicable parts of the OLAW Animal Welfare Assurance.

OLAW oversees animal activities conducted by Assured Institutions and requires compliance with the Public Health Service (PHS) Policy on the Humane Care and Use of Laboratory Animals (Policy). The PHS Policy section IV.A. states that no activity involving animals may be conducted or supported by the PHS until the institution conducting the activity has provided a written Assurance acceptable to the PHS, setting forth compliance with the Policy. Through memoranda of understanding, this requirement also applies to activities conducted or supported by the National Aeronautics and Space Administration (NASA), National Science Foundation (NSF), and Department of Veterans Affairs (VA).

All Assurances under negotiation by OLAW are evaluated to determine the adequacy of the institution’s proposed program for the care and use of animals. The current Domestic Assurance format addresses critical elements of an animal care and use program as required by the PHS Policy IV.A.1.-3. to ensure compliance.

Inquiries

Please direct all inquiries to:

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