Obtaining an Assurance

The following resources are provided to assist Public Health Service (PHS) awardee institutions in obtaining an Animal Welfare Assurance (Assurance).

Introduction

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.”

Criteria for Obtaining an Assurance

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 oversees PHS-funded animal activities. PHS funding components include the National Institutes of Health (NIH), the Centers for Disease Control and Prevention (CDC), Food and Drug Administration (FDA), and the Biomedical Advanced Research and Development Authority (BARDA). Through memoranda of understanding, OLAW additionally oversees animal activities funded by the National Aeronautics and Space Administration (NASA), National Science Foundation (NSF), and the 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.

Process of Obtaining an Assurance

The PHS funding component notifies the institution of a pending grant or contract award (Notice of Award).
If the awardee institution does not already have an Assurance, the funding component notifies OLAW that an Assurance is required.
OLAW contacts the institution to negotiate an Assurance. Note: OLAW does not accept or process unsolicited applications.
The institution prepares an Assurance document and submits it to OLAW.
OLAW negotiates with the institution until the Assurance document meets the standards of the PHS Policy. Note: the institution may propose a program that exceeds the standards of the PHS Policy. After OLAW approves the Assurance document, the institution will be required to meet the standards they have proposed.
OLAW notifies the institution and funding component that an Assurance has been approved. The approval period will be for a specified time. Domestic Assurances are approved for a period of up to 4 years. Interinstitutional Assurances are approved for the life of the grant/contract up to 5 years. Foreign Assurances are approved for a period of up to 5 years.
Assured institutions are listed on the OLAW homepage:
- Domestic Assured institutions
- Foreign Assured institutions

Three Types of Assurances

Domestic Assurance

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:

control their own animal facilities
conduct animal research on-site
have an animal care and use program with:
- an Institutional Official (IO)
- an Institutional Animal Care and Use Committee (IACUC)
- a veterinarian with program authority and access to all animals

This Assurance is not to be used by:

Foreign institutions
Institutions that do not have their own animal care and use program
Institutions proposing to conduct an animal activity solely at a secondary institution(s)

Elements of the Assurance include:

Components of the institution that will be covered by the Assurance
Institutional commitment to the Animal Welfare Act, the U.S. Government Principles and the Guide for the Care and Use of Laboratory Animals
Description of program for animal care and use
Program evaluation and accreditation
Recordkeeping
Reporting to OLAW
Institutional endorsement
Membership of the IACUC
Facility and species inventory

Assurance Renewal

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.).

Report Program Changes

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

Submit Assurance and program changes to OLAW via e-mail to [email protected].

Additional References

Animal Welfare Assurances - this section of the Topic Index provides additional guidance on Assurances found in Commentaries, Articles, FAQs, and NIH Guide Notices.
Writing a Good Assurance - this OLAW Online Seminar, broadcast on June 9, 2011, discusses the parts of the Assurance and what is required in each section.
Sample Documents - sample Assurance documents and other sample documents can be found on this webpage.
NOT-OD-14-099 - Notice of Change in Criteria for Renewal of Domestic Animal Welfare Assurances
NOT-OD-12-081 - Change in Criteria for Renewal of Animal Welfare Assurances for Foreign Institutions

Questions?

Telephone (301-496-7163) or e-mail ([email protected]) the Division of Assurances for answers to your questions.

Division of Assurances

Phone: 301-496-7163
E-mail: [email protected]

Mailing Address:

Division of Assurances
Office of Laboratory Animal Welfare
National Institutes of Health
6700B Rockledge Drive, Suite 2500
Bethesda, MD 20892-6910

[20817 zip code for mail delivery service]