Notice Number: NOT-OD-14-099
Release Date: May 29, 2014
National Institutes of Health (NIH)
This Notice informs Public Health Service (PHS) awardee institutions of a change in the criteria for renewing the Domestic Animal Welfare Assurance (Domestic Assurance). Previously, Domestic Assurances were renewed, regardless of funding, every four years, provided that the institution submitted a renewal Domestic Assurance document to the NIH Office of Laboratory Animal Welfare (OLAW) prior to the expiration date. Under the new criteria, Domestic Assurances will be renewed only if the institution has current PHS funding.
The PHS Policy on Humane Care and Use of Laboratory Animals (Policy) requires 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.” U.S. institutions that receive PHS funds through a grant or contract award are required to have a Domestic Assurance approved by OLAW before conducting activities involving live vertebrate animals. Domestic institutions without current direct or indirect PHS funding have no requirement to maintain an active Domestic Assurance.
OLAW approves Domestic Assurances for periods of four years. Six months prior to the end of the approval period, OLAW contacts Assured institutions and requests submission of a renewal within 120 days of the expiration date. This timeline allows for OLAW to negotiate, review, and approve the Assurance prior to the expiration date.
Criteria for Renewal of Domestic Assurances
Effective December 1, 2014, OLAW will not renew a Domestic Assurance unless the institution has current direct or indirect PHS funding for activities involving animals. PHS funding components include the NIH, the Centers for Disease Control and Prevention (CDC), and the Food and Drug Administration (FDA). Institutions without current funding will receive a letter of inactivation on the expiration date of their Domestic Assurance. Lack of an Assurance will not adversely affect the institution’s ability to apply for future PHS funding. If OLAW is notified by a PHS funding component that the institution has been selected for an award or is named as a performance site for another institution’s PHS-supported research, OLAW will negotiate a new Domestic Assurance.
Institutions are reminded that without a valid Domestic Assurance approved by OLAW, PHS-supported research and/or other activities involving live vertebrate animals may not be conducted.
For questions or further information, contact:
Division of Assurances
Office of Laboratory Animal Welfare
Office of Extramural Research
National Institutes of Health