Notice Number: NOT-OD-08-049
Key Dates
Release Date: February 15, 2008
Issued by
Office of Laboratory Animal Welfare (OLAW), Office of Extramural Research (http://grants.nih.gov/grants/olaw/olaw.htm)
This Notice informs Public Health Service (PHS) grantee institutions regarding revisions to the sample Animal Welfare Assurance document (Assurance).
Background
The Public Health Service Policy on the Humane Care and Use of Laboratory Animals (PHS Policy) requires that institutions conducting activities involving live vertebrate animals supported by the PHS have a written Assurance, acceptable to OLAW, assuring institutional compliance with the PHS Policy. OLAW is required by the PHS Policy to provide instructions and an example of an acceptable Assurance to grantee institutions.
Changes to the Sample Assurance Document
OLAW updated the sample Assurance document in January 2008. Changes to the document clarify essential information and define the elements that are required in the Assurance. The Assurance is intended to be a stand-alone document that succinctly describes the animal care and use program of an institution. Therefore, the required materials have been streamlined to reduce regulatory burden on the grantee institution. Institutions that submit Assurances after April 15, 2008 are asked to follow the format of the revised sample Assurance. Attachments must be limited to those requested in the new sample document. These include:
- Organizational chart of the animal care and use program,
- IACUC membership roster,
- Facility and species inventory form.
- If (and only if) the institution is not accredited by the Association for the Assessment and Accreditation of Laboratory Animal Care (AAALAC), institutions must include the semi-annual report to the Institutional Official of the most recent Program Review and Facility Inspection.
OLAW will no longer accept the following documents as attachments:
- Curriculum vitae (CV) of the veterinarian or the IACUC members,
- Description of the institutional occupational health and safety program,
- Description of the animal care and use training program.
All program elements, including items 1, 2, and 3 (above), must be described in the text of the Assurance. OLAW will no longer accept attachments or addendums as part of the Assurance document, except as described in the bulleted list (above). However, an Assurance Officer may request additional materials, as necessary to help clarify the description of the animal care and use program.
Part III, Section E. has been eliminated from the Assurance because this requirement is completedas part of the electronic grant application.
All of the requested information is in accordance with Part IV.F.of the PHS Policy as revised in August 2002.
Effective April 15, 2008, adherence to the new sample Assurance document is requested. For ease of submission, the signed Animal Welfare Assurance may be converted to a PDF file and submitted to the OLAW Division of Assurances email box at olawdoa@mail.nih.gov
A reminder about renewal of the Assurance
Institutions are reminded that as of July 2004, OLAW approves Assurances for periods up to four years. OLAW may, at its discretion, administratively extend the approval date of a four-year Assurance while the renewal is under negotiation, up to five years as allowed by the PHS Policy. It is incumbent upon the institution to actively participate in the negotiation process so the renewal Assurance is approved in a timely manner. Institutions are reminded that without a valid Assurance approved by OLAW, an institution may not conduct PHS-supported research or other activities involving live vertebrate animals.
Institutions that currently have an Assurance with a five-year approval period will be contacted by OLAW six months prior to the expiration date and asked to submit their renewal within 60 days of notification (four months prior to the expiration date) in order for the renewal to be negotiated and approved within the PHS Policy timeframe.
Institutions are encouraged to review the updated sample Assurance and make use of this new resource when submitting a new or renewal Assurance.
Inquiries
For questions or further information, contact:
Office of Laboratory Animal Welfare
Division of Assurances
National Institutes of Health
Rockledge 1, Suite 360, MSC 7982
6705 Rockledge Drive
Bethesda, MD: 20892-7982
phone: 301-496-7163
fax: 301-402-7065
e-mail: olawdoa@od.nih.gov
and Human Services (HHS)
