Form 3 Foreign Assurance

OMB Number 0925-0765
Expiration Date: 11/30/2022

Animal Welfare Assurance for Foreign Institutions

Name of Institution:

Address: [street, city/town, state/province/other, postal code, country]

This Institution agrees, by signature of the Authorized Institutional Official below, to comply with the Public Health Service (PHS) Policy on Humane Care and Use of Laboratory Animals (Policy), or provide evidence to the PHS in this document that acceptable standards for the humane care and use of the animals in PHS, National Science Foundation (NSF), and/or National Aeronautics and Space Administration (NASA) conducted or supported activities will be met.

1. Applicability

This Animal Welfare Assurance for Foreign Institutions (Foreign Assurance) is applicable to all research, research training, and biological testing activities involving live, vertebrate animals supported by the PHS, NSF, and/or NASA and conducted at this Institution. PHS funding sources include the Centers for Disease Control and Prevention (CDC), Food and Drug Administration (FDA), National Institutes of Health (NIH), and Biomedical Advanced Research and Development Authority (BARDA). This Assurance covers only those facilities and components listed below.

1. The following branches and components over which this Institution has legal authority, including those that operate under a different name: [List only institutions that will conduct animal research on the grant or contract. All institutions listed must be under the Assured institution’s legal, financial, and administrative authority. MUST COMPLETE THIS SECTION]

   
   

   
   

   
   

   
   

2. The following other institutions or branches and components of another institution with which this Institution has a legal relationship: [List only institutions that will conduct animal research as a subgrant or subcontract. They must be recipients of PHS, NSF, and/or NASA funding or an imminent PHS, NSF, and/or NASA award. If no other institutions, write none or n/a]

2. Institutional Commitment

This Institution is guided by the International Guiding Principles for Biomedical Research Involving Animals (PDF). This Institution will comply with all applicable provisions of the following laws, regulations, and policies governing the care and use of animals. [List titles in English of all governing laws, regulations, and policies for your jurisdiction including national, regional, and local ordinances. MUST COMPLETE THIS SECTION]

This Institution acknowledges and accepts responsibility for the care and use of animals involved in activities covered by this Foreign Assurance. As partial fulfillment of this responsibility, this Institution will make reasonable efforts to ensure that all individuals involved in the care and use of animals understand their individual and collective responsibilities for compliance with all applicable laws, regulations, and policies pertaining to animal care and use.

Check one: [MUST COMPLETE THIS SECTION]

[ ] This Institution is accredited by AAALAC International.

[ ] This Institution is not accredited by AAALAC International.

Check one: [MUST COMPLETE THIS SECTION]

[ ] This Institution is certified by the Canadian Council on Animal Care (CCAC).

[ ] This Institution is not certified by the CCAC.

3. Compliance

This Institution, through the Authorized Institutional Official, will promptly provide the Office of Laboratory Animal Welfare (OLAW) with a full explanation of the circumstances and actions taken with respect to:

1. Any serious or continuing noncompliance with this Assurance

2. Any suspension of an animal activity by the responsible Animal Welfare Committee or Oversight Body.

Serious or continuing noncompliance with this Assurance includes noncompliance with the International Guiding Principles for Biomedical Research Involving Animals or any laws, regulations, or policies listed in Section II. Institutional Commitment.

[Visit https://olaw.nih.gov/guidance/reporting-noncompliance.htm for reporting guidance]

4. Description of Oversight

The following provides an overview of this Institution’s Animal Welfare Committee or Oversight Body and describes responsibilities for review of research using live, vertebrate animals.

5. Notification

This Institution agrees to notify OLAW when contact information changes and will include the Foreign Assurance number in all correspondence. Notifications must be sent by e-mail to [email protected].

6. Annual Reporting

This Institution, through the Authorized Institutional Official, must submit an Annual Report to OLAW no later than <<Date Input>> of each year. The Annual Report must include:

1. Current PHS, NSF, and/or NASA funding status for animal activity conducted at this Institution.

2. Any change in the AAALAC International accreditation and/or CCAC certification status (e.g., if the Institution obtains accreditation or certification or if accreditation or certification is revoked)

3. Confirmation of whether reports, as described in Section III. Compliance of this Assurance, were submitted to OLAW

4. Any change in Institutional Commitment including changes to applicable provisions of laws, regulations, and policies governing the care and use of animals.

5. Any change in Description of Oversight

6. Any change in Authorized Institutional Official and/or Institutional Contacts.

1. Institutional Contacts

[Two additional Institutional contacts are required. Examples include chairperson, animal or review committee member, institutional representative, regulatory official, veterinarian, or grants official. MUST COMPLETE THIS SECTION]

Contact #1
Name:
Title:
Name of Institution:
Phone:	E-mail:

Contact #2
Name:
Title:
Name of Institution:
Phone:	E-mail:

8. Institutional Endorsement

A. Authorized Institutional Official [MUST COMPLETE THIS SECTION]
Name:
Title:
Name of Institution:
Address: [street, city/town, state/province/other, postal code, country]
Phone:	E-mail:
Signature:	Date (month/day/year):

B. PHS Approving Official [to be completed by OLAW]
Name/Title: Office of Laboratory Animal Welfare (OLAW) National Institutes of Health Bethesda, Maryland USA Phone: +1 (301) 496-7163
Signature & Date:
Foreign Assurance Number:
Effective Date:	Expiration Date:

Statement of Burden

Public reporting burden for this collection of information is estimated to average 90 minutes per response, including the time for reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and completing and reviewing the collection of information. An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. Send comments regarding this burden estimate or any other aspect of this collection of information, including suggestions for reducing this burden, to: NIH, Project Clearance Branch, 6705 Rockledge Drive, MSC 7974, Bethesda, MD 20892-7974, ATTN: PRA (0925-0765). Do not return the completed form to this address.

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