|Policy & Guidance|
|Compliance & Oversight|
|Research Involving Human Subjects|
|Office of Laboratory Animal Welfare (OLAW)|
|Animals in Research|
|Peer Review Policies & Practices|
|Guidance for Reviewers|
|Intellectual Property Policy|
|Acknowledging NIH Funding|
|Invention Reporting (iEdison)|
|NIH Public Access|
The following resources are provided to assist Public Health Service (PHS) awardee institutions in obtaining an Animal Welfare Assurance (Assurance).
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). The PHS Policy, section IV.A., 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.”
Institutions must have an Assurance on file with OLAW to receive PHS funding. If the institution does not have a valid Assurance, the funding component will ask OLAW to negotiate an Assurance before the grant, contract or cooperative agreement is awarded.
Sometimes an institution receives PHS funds and chooses to conduct the animal activities at a secondary institution(s). Activities subcontracted or subgranted to the secondary institution(s) are funded through a mechanism referred to as indirect funding. In this case, the secondary institution(s) must be named as a performance site by the prime awardee institution. After approving the performance site, the funding component will contact OLAW to negotiate an Assurance with the secondary institution(s).
OLAW assures PHS-funded animal activities. PHS funding components include the National Institutes of Health (NIH), the Centers for Disease Control and Prevention (CDC), and the Food and Drug Administration (FDA). OLAW does not oversee animal activities funded by the National Science Foundation (NSF), the Department of Defense (DoD), the U.S. Department of Agriculture (USDA), and non-profit or for-profit organizations.
The Domestic Assurance is required for U.S. institutions that receive PHS funds through a grant or contract award. Domestic Assurances are approved for a period of up to 4 years and will be renewed only if the institution continues to receive PHS funds, either directly or indirectly. (See NOT-OD-14-099)
Domestic Assurances are negotiated with institutions that:
This Assurance is not to be used by:
Elements of the Assurance include:
The Interinstitutional Assurance is required when the awardee institution does not have its own:
The institution will perform the animal activity at a secondary Assured institution(s) named as the performance site.
Requirements of the Interinstitutional Assurance:
Interinstitutional Assurances are approved for the life of the grant/contract up to 5 years.
See also, sample Interinstitutional Assurance.
The Foreign Assurance is required for institutions outside the U.S. that receive PHS funds directly through a grant or contract award. The Foreign Assurance also applies to institutions outside the U.S. that receive PHS funds indirectly (named as a performance site by a primary awardee institution). (See NOT-OD-12-081)
Foreign Assurances are approved for a period of up to 5 years. Foreign Assurances will be renewed only if the institution continues to receive PHS funds, either directly or indirectly.
Foreign Assurances are negotiated with institutions that:
The foreign institution must provide:
The process for renewing an Assurance is similar to the process of obtaining a new Assurance. Your institution will receive a reminder letter prior to the expiration date with instructions for submitting a renewal. Note: Assurances will be renewed only if the institution continues to receive PHS funds, either directly or indirectly. OLAW requests institutions to submit the Domestic Assurance renewal document 4 months prior to the expiration date to allow time for review. It is important to submit the renewal documents promptly because the institution may not accept funds for animal activities unless the institution has a valid Assurance on file with OLAW (PHS Policy, section V.B.).
Changes that occur in an institution’s animal care and use program after the Assurance is approved but before it is renewed, should be described in the next annual report to OLAW. However, a change in the IO or IACUC chair should be forwarded to OLAW immediately because OLAW communicates with the institution through the IO and the IACUC chair.
Submit Assurance and program changes to OLAW by fax to 301-451-5672 or e-mail to firstname.lastname@example.org.
Telephone (301-496-7163) or e-mail (email@example.com) the Division of Assurances for answers to your questions.
Division of Assurances
Division of Assurances
Office of Laboratory Animal Welfare
National Institutes of Health
Rockledge 1, Suite 360
6705 Rockledge Drive
Bethesda, MD 20892-7982
[20817 zip code for mail delivery service]
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