The Public Health Service (PHS) Policy on Humane Care and Use of Laboratory Animals (Policy) requires that institutions have an OLAW-approved Animal Welfare Assurance before carrying out any activities involving live vertebrate animals. Institutions outside the U.S. that receive PHS funds directly through a grant or contract award are to use the Animal Welfare Assurance for Foreign Institutions (Foreign Assurance). The Foreign Assurance also applies to institutions outside the U.S. that receive PHS fund indirectly (as a performance site through a primary institution).
Foreign Assurances are negotiated with institutions that:
- control their own animal facilities
- conduct animal research on-site
- have an animal care and use program with an authorized institutional signing official
The Foreign Assurance commits the institution to:
- Comply with the PHS Policy, or provide evidence that acceptable standards for the humane care and use of animals will be met
- Follow the International Guiding Principles for Biomedical Research Involving Animals (PDF)
- Comply with all applicable laws, regulations and policies governing animal care and use for their country of jurisdiction
Foreign institutions may apply for a Foreign Assurance if either of the following conditions exist:
- The institution has submitted a PHS grant application or contract proposal and has received notification from the funding component that the grant or contract will be awarded, or;
- The institution is listed as a performance site on a PHS grant or contract, either foreign or domestic, AND award of the grant or contract is imminent.
The application process begins when the PHS funding component makes a determination to award a grant or contract. The funding component will notify OLAW that an Assurance is required for the pending award. OLAW will contact the awardee institution to negotiate the applicable Assurance(s).
Institutions should not submit an Assurance unless requested to do so by OLAW. OLAW will not process unsolicited applications.
If you have been notified that the grant or contract will be awarded AND have not been contacted by OLAW, you may submit an inquiry by e-mail to firstname.lastname@example.org. Include the grant or contract number and contact information from the funding component in the e-mail.
Foreign Assurances cannot be renewed if the institution is no longer receiving PHS funds.
We have provided this sample document to help you develop an acceptable Foreign Assurance. Words that are italicized and in brackets [like this] indicate specific information you must provide about your animal care and use program.
In Item I, Applicability, identify all components (institutes, hospitals, clinics) that are under your jurisdiction and which you wish to include in your Foreign Assurance.
In Item II, Commitment, provide a list in English of all applicable national, regional and local laws, regulations and policies governing the care and use of laboratory animals.
Fax your completed Foreign Assurance to +1 (301) 451-5672 or e-mail to email@example.com. Do not submit any other documents. We do not accept separate attachments, appendices, binders, or manuals.
- Institutional Commitment
- Institutional Endorsement and PHS Approval
- Institutional Contacts
If you wish to use the sample Foreign Assurance as a template, click one of the formats below to download.
Contact the Division of Assurances by telephone at +1 (301) 496-7163 or e-mail to firstname.lastname@example.org.