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The following resources are provided to assist Public Health Service (PHS) awardee institutions in obtaining an Animal Welfare Assurance (Assurance). It is the responsibility of National Science Foundation (NSF) or National Aeronautics and Space Administration (NASA), not individual investigators, to establish and maintain an Assurance. Institutions should not submit any Assurance materials unless first contacted by OLAW.
What is an Assurance?
An Assurance is a contract with the Federal Government that describes the institutional program of animal care and use and documents institutional commitment. Institutions must have an approved Assurance on file with OLAW to receive funding involving PHS-conducted or supported activities involving live vertebrate animals. An approved OLAW Assurance is required for compliance with the PHS Policy, NIH Grants Policy Statement, and Health and Human Services Acquisitions Regulations.
If activities with animals involve other institutions such as collaborators, subawardees, or will be performed at other institutions, these institutions must be identified by the prime recipient (awardee) and are required to have an approved Assurance with OLAW. The prime recipient (awardee) is responsible for notifying the funding component, and after approving the additional institution involvement, the funding component will contact OLAW to negotiate an Assurance with the other institution(s).
OLAW oversees PHS-conducted or supported funded animal activities. These include animal activities conducted at or funded by the U.S. Department of Health and Human Services agencies such as:
- National Institutes of Health (NIH),
- Centers for Disease Control and Prevention (CDC),
- Food and Drug Administration (FDA),
- Biomedical Advanced Research and Development Authority (BARDA), etc.
Through memoranda of understanding (MOUs), OLAW additionally administers the PHS Policy for activities funded by:
- National Aeronautics and Space Administration (NASA)
- National Science Foundation (NSF)
- Department of Veterans Affairs (VA)
OLAW does not oversee animal activities funded by the Department of Defense (DoD), the U.S. Department of Agriculture (USDA), and non-profit or for-profit organizations unless those activities are also receiving PHS funds.
Quick References
- Assured Institutions Look Up Tool
- Domestic Animal Welfare Assurance
- Foreign Animal Welfare Assurance
- Interinstitutional Animal Welfare Assurance
Laws, Policies, and Guidance
OLAW oversees PHS-funded animal activities by the authority of the Health Research Extension Act of 1985 and the PHS Policy on Humane Care and Use of Laboratory Animals (Policy).
PHS Policy IV.A. “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.”
| Notice | Description | Date |
|---|---|---|
| NOT-OD-21-130 | Notice to Encourage Using AAALAC International Program Description Sections to Complete Parts of the OLAW Domestic Animal Welfare Assurance | June 4, 2021 |
| NOT-OD-14-099 | Notice of Change in Criteria for Renewal of Domestic Animal Welfare Assurances | May 29, 2014 |
| NOT-OD-13-096 | Implementation of the Revised International Guiding Principles for Biomedical Research Involving Animals | August 2, 2013 |
| NOT-OD-12-081 | Change in Criteria for Renewal of Animal Welfare Assurances for Foreign Institutions | March 8, 2012 |
| NOT-OD-12-021 | Update of Sample Interinstitutional Assurance | December 1, 2011 |
| NOT-OD-10-083 | Update of Sample Animal Welfare Assurance for Foreign Institutions | April 16, 2010 |
| NOT-OD-10-081 | Guidance on Confirming Appropriate Charges to NIH Awards during Periods of Noncompliance for Activities Involving Animals | April 15, 2010 |
| NOT-OD-08-049 | Update of Sample Animal Welfare Assurance | February 15, 2008 |
| NOT-OD-07-044 | NIH Policy on Allowable Costs for Grant Activities Involving Animals when Terms and Conditions are not Upheld | January 26, 2007 |
| NOT-OD-04-052 | Office of Extramural Research Notice Regarding Animal Welfare Documents Submitted to the Office of Laboratory Animal Welfare | July 13, 2004 |
Domestic and Foreign Assurance Review Process
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Step 1: OLAW Requests Documents
For both new and renewal Assurances, OLAW requests a completed Assurance form with the Institutional Official’s (IO) signature. The form is the same for both new and renewal Assurances. The completed form is assigned to a reviewer within OLAW who requests any clarifications or changes necessary to align the program with regulatory expectations.
- In the case of a new Assurance, the funding component notifies the institution and OLAW of a pending award or addition of animal activities. OLAW then contacts the institution to negotiate an Assurance. Note that OLAW does not accept or process unsolicited applications.
- In the case of Assurance renewal, OLAW issues a request letter prior to the expiration date with instructions for submitting a renewal. OLAW requests institutions to submit the Assurance renewal document 4 months prior to the expiration date to allow ample time for review. It is important to submit the renewal documents promptly. Note that Assurances will be renewed only if the institution continues to receive PHS, NSF, or NASA funds.
Tip: Incorporate all requested information into the body of the Assurance form.Do not include any separate binders, policies, or manuals. Similarly, do not copy-paste any policies or manuals into the Assurance text. Exceptions for Domestic Assurances are outlined below:
- You may include one or two-page attachments to provide the organizational structure of the animal care and use program, IACUC member roster, and facility and species inventory.
- If your institution is Category 2 (those not accredited by AAALAC International), you must provide the most recent Semiannual Report to the IO with the completed Assurance. The Semiannual Report to the IO may be provided as a separate file.”
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Step 2: Institution Submits Revisions
The Institution makes any requested changes and submits a revised Assurance directly to the assigned reviewer. The revised Assurance should be provided, with any changes highlighted or in a different color font to facilitate review. The reviewer examines the revised Assurance and notes any additional concerns or questions. Further discussion may be necessary by email or other telecommunication. Any subsequent revisions should be submitted directly to the assigned reviewer, but note that interim versions do not need to be signed by the IO.
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Step 3: The Assurance is Approved
Once the reviewer determines that the Assurance is consistent with regulatory requirements, the institution is asked to provide a final Assurance via email with the signature of the IO. This version is also signed by OLAW and an approval letter and copy of the finalized Assurance are provided to the institution.
The approval period will be for a specified time for a period of up to 4 years.