Notice Number: NOT-OD-12-081

Key Dates
Release Date: March 8, 2012

Issued by
National Institutes of Health (NIH)

Purpose

This Notice informs Public Health Service (PHS) grantee institutions of a change in the criteria for renewing the Animal Welfare Assurance for Foreign Institutions (Foreign Assurance). Previously, Foreign Assurances were renewed, regardless of funding, every five years, provided that the institution submitted a renewal Foreign Assurance document to OLAW prior to the expiration date. Under the new criteria, Foreign Assurances are renewed only if the institution has current PHS funding.

Background

The PHS Policy on Humane Care and Use of Laboratory Animals (Policy) requires that institutions in foreign countries receiving PHS support for activities involving animals shall have an approved Foreign Assurance on file with OLAW. Foreign institutions without current direct or indirect PHS funding have no requirement to maintain an active Foreign Assurance with OLAW.

Criteria for Renewal of Foreign Assurances

OLAW will not renew a Foreign Assurance past the expiration date, 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 and the Food and Drug Administration. Institutions without current funding will receive a letter of inactivation on the expiration date of their Foreign 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 Foreign Assurance.

Approval of Foreign Assurances

OLAW approves Foreign Assurances for periods up to five years. Foreign institutions that currently have a Foreign Assurance will be contacted by OLAW four months prior to the expiration date and asked to submit their renewal within 60 days of the expiration date in order for the renewal to be reviewed and approved within the required time. It is incumbent upon the foreign institution to appropriately complete the Foreign Assurance document. Requirements include:

• listing of the titles in English of all governing laws, regulations and policies for the country of jurisdiction,
  
• signature, name and contact information of the Institutional Signing Official, and
  
• names and contact information for two additional institutional representatives.

OLAW encourages foreign grantees to use the standards in the Guide for the Care and Use of Laboratory Animals: 8th Edition (Guide). Institutions are reminded that without a valid Foreign Assurance approved by OLAW, PHS-supported research and/or other activities involving live vertebrate animals may not be conducted.

Inquiries

For questions or further information, contact:

Division of Assurances
Office of Laboratory Animal Welfare
Office of Extramural Research
National Institutes of Health
RKL1, Suite 360
6705 Rockledge Drive
Bethesda, MD 20892-7982
Phone: 301-496-7163
Fax: 301-915-9465
E-mail: [email protected]
Web: http://olaw.nih.gov/