NMU's Compliance Database - Northern Michigan University

Public Health Service (PHS) Animal Welfare Policy Assurances approved by the Office of Laboratory Animal Welfare (OLAW) last for a maximum period of four years before they require renewal and will be renewed only if the institution continues to conduct live, vertebrate animal work onsite for PHS, NSF, or NASA-funded or supported animal activities.

Basic Elements of the Assurance

The following are the basic tenets that should be addressed in every Assurance. The Assurance form provides prompts for each of these areas.

• Facilities and 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

The 4-Year Renewal Process

• Notice from OLAW: OLAW reaches out to the institution six months before the four-year approval ends.
• Timeline: This six-month window gives the office enough time to review, negotiate, and approve the new agreement.
• Funding Check: OLAW will only renew the agreement if the institution still has active PHS funding support from agencies like the National Institutes of Health (NIH), the Centers for Disease Control and Prevention (CDC), or the Food and Drug Administration (FDA)

Key Program Requirements

To keep the four-year assurance active, your institution must maintain:

• An active Institutional Official (IO) who signs the documents.
• An Institutional Animal Care and Use Committee (IACUC) that meets and inspects facilities at least twice a year.
• A qualified veterinarian with full program authority.
• A program based on the standard Guide for the Care and Use of Laboratory Animals.

Checklist for required institutional documentation and committee sign-offs needed for your 4-year PHS (OLAW) Animal Welfare Assurance renewal.

Core Institutional Documentation

• Renewal Application Form: Complete the official, unaltered OLAW boilerplate text matching your institution type (Domestic, Foreign, or Interinstitutional).
• Line of Authority Org. Chart: Create a clear diagram showing the distinct reporting lines between the Institutional Official (IO), the IACUC, and the Attending Veterinarian (AV).
• Facility and Species Inventory: Compile a list of all animal care facilities, their square footage, and the average daily animal inventory by species.
• AAALAC Accreditation Status: Provide your current accreditation status, including the date of your last site visit and any correspondence regarding your status.

IACUC Committee Membership Roster

• Chairperson: Identify the designated committee chair.
• Attending Veterinarian: Document the AV's name, degree, and specific training/experience in laboratory animal medicine.
• Scientist Member: List at least one scientist with research experience involving animals.
• Non-Scientist Member: Include at least one member whose primary concerns are in a non-scientific area (e.g., ethicist, lawyer, clergy).
• Public Member: Appoint at least one individual who is entirely unaffiliated with the institution and represents community interests.

Required Committee Programs & Sign-offs

• Institutional Official (IO) Signature: Secure the legal signature of the high-level official who has the administrative and financial authority to commit institutional resources.
• IACUC Chair Signature: Obtain the signature confirming committee review and approval of the Assurance document.
• Occupational Health and Safety Program (OHSP): Document the written medical surveillance and safety program details for all personnel with animal contact.
• Training Program Records: Detail the mandatory orientation and continuing education curriculum for investigators, technicians, and IACUC members.
• Veterinary Care Program: Include written descriptions of preventive medicine, triage, anesthesia, analgesia, and euthanasia protocols.

Format, Submission, and Reporting: Writing Your Assurance Document

Institutions that meet the criteria for a Domestic Assurance must download and use the Domestic Assurance form to describe their program of animal care and use. Specific instructions, information, and recommended references are provided in the italicized text and should be deleted from the final document. Submissions should be clear and concise, should utilize the section headings, and retain the numbering and format included on the form. 

One or two page attachments can be used to provide the following:

• Organizational structure for the animal care and use program 
• IACUC membership roster 
• Facility and Species inventory

Category 2 institutions (those not accredited by AAALAC International) 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 and should include all PHS Policy-required components as described in PHS Policy IV.B.3.c-e and Section III.D.3. of  the Assurance document. OLAW highly recommends the use of the sample document Semiannual Report to the IO.