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Reporting Requirements to Regulatory/Certification Authorities

Date adopted: February 14, 2006

Last updated: August 1, 2014


Policies and procedures for the Office for Laboratory Animal Welfare (OLAW), U.S. Department of Agriculture (USDA) and Association for Assessment and Accreditation of Laboratory Animal Care International (AAALAC) require that regular submissions be made to these agencies to keep them informed on the status of animal care and use activities at the University of Montana (UM). The UM Institutional Animal Care and Use Committee (IACUC) is also required to make regular submissions to the Institutional Official (IO).

Policy Procedures

  • Internal Reporting Policies
    • Semiannual Program Reviews and Facility Inspections
      • A draft of the report to the IO will be written by the IACUC Coordinator and approved by the IACUC within one month of the inspection
      • The report must contain a description of the nature and extent of the institution's compliance with the Public Health Service (PHS) Policy and Guide for the Care and Use of Laboratory Animals; any departures must be identified and modifications proposed, with a plan and timetable for correction. Minority views of IACUC members must be included.
      • Final reports must be submitted by the IACUC to the IO semiannually and kept for at least three years.
      • Once submitted, electronic version of the final reports will be posted on the IACUC password-protected web site and the records (paper and e-version) will be kept for at least three years.
  • External Reporting Policies
    • Office of Laboratory Animal Welfare (OLAW)
      • Assurance of Compliance with PHS Policy
        • Assurances are approved for a period of up to five years, after which time the institution must submit a new request for a Letter of Assurance.
        • The IACUC Coordinator will provide a written agreement to the IO that fully describes the institution's program and commits the organization to comply with the PHS Policy, and in which the institution outlines in detail its policies and procedures. See the OLAW web site, grants.nih.gov/grants/olaw/olaw.htm
        • The IO submits the document to OLAW
        • An Assurance number is assigned by OLAW to the University of Montana
      • Complaints, violations, and suspension of activities
        • The designee of the IACUC Chair (currently the IACUC Coordinator) must report promptly (telephone call or written report) to the Director of Compliance and Oversight at OLAW, through the IO, stating the circumstances and corrective actions taken and any minority views filed in the following instances:
          • suspension of any activity by the IACUC
          • serious or continuing non-compliance with the PHS Policy
          • significant deviation from the provisions of the Guide for the Care and Use of Laboratory Animals
        • The contents of the PHS Suspension/Noncompliance Report will include:
          • a full explanation of circumstances
          • description of corrective action taken
          • minority views filed by IACUC
      • Annual Report
        • The IACUC Coordinator drafts an annual report that is submitted to OLAW, through the IO, at least once every 12 months
        • The Annual Report to OLAW is due on January 31 and includes activities of the previous calendar year. OLAW web site, grants.nih.gov/grants/olaw/olaw.htm
      • All reports are available on the password protected IACUC web site and are available for a minimum of 3 years. Hard copies are kept in the office of the IACUC Coordinator for a minimum of 3 years.
    • USDA
      • USDA Research Facility Registration
        • Registration will be updated every 3 years
        • Forms will be filled out by the DLAR and signed by the IO. Refer to USDA web site, www.aphis.usda.gov/ac/researchmanual/3-6RENWL.PDF
        • USDA form #7011 will be submitted by the IO to APHIS via the Western Regional Director of Animal Care (AC)
      • Complaints, violations, and suspension of activities
        • If the IACUC suspends any activities involving USDA-regulated animals, the IO will file a prompt report with the Western Regional Director of Animal Care and any federal agency funding the activity. Prompt reporting may be done by telephone, noting the date of suspension.
      • Annual Report
        • On or before December 1, each facility registered with USDA must submit an annual report to the USDA/APHIS, Western Regional Director for Animal Care describing activity during the previous Federal fiscal year (October 1 - September 30).
        • The Annual Report is prepared by the IACUC Coordinator and signed by the IO
      • All reports are available on the password protected IACUC web site for a minimum of three years. Hard copies are available in the office of the IACUC Coordinator for a minimum of 3 years.
    • AAALAC
      • Program Description
        • Triennial submission as directed by AAALAC prior to site visit
        • Written by the IACUC Coordinator and reviewed by the IACUC and IO.
        • The Institutional AAALAC Correspondent will send the Program Description to the Senior Director, AAALAC International. Currently, the IACUC Coordinator is the Institutional AAALAC Correspondent.
      • Annual Report
        • Written by the IACUC Coordinator to the President, Council on Accreditation, through the IO
      • Complaints and violations
        • If the IACUC suspends any activities involving either USDA-regulated animals or non-USDA animals, the IO will file a prompt report with AAALAC
      • All reports are available on the password protected IACUC web site for a minimum of three years. Hard copies are available in the office of the IACUC Coordinator for a minimum of 3 years.