Reporting Requirements to Regulatory/Certification Authorities

Date Adopted: February 14, 2006

Last Review Date: September 13, 2017


I.  Policy

Policies and procedures for the Office of Laboratory Animal Welfare (OLAW), U.S. Department of Agriculture (USDA) and AAALAC International 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).

II. Procedures

A.  Internal Reporting Policies
1.  Semiannual Program Reviews and Facility Inspections
a.  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
1)  The template for the Report to the IO is from the OLAW web site
b.  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.
c.  Final reports must be submitted by the IACUC to the IO semiannually and
      kept for at least three years.
d.  Once submitted, an 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.

B.  External Reporting Policies
1.  Office of Laboratory Animal Welfare (OLAW)
a.  Assurance of Compliance with PHS Policy
1)  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.
2)  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
     https://grants.nih.gov/grants/olaw/olaw.htm
3) The IO submits the document to OLAW
4)  An Assurance number is assigned by OLAW to the University of
     Montana
b.  Complaints, violations, and suspension of activities
1)  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:
a)  Suspension of any activity by the IACUC
b)  Serious or continuing non-compliance with the PHS Policy
c)  Significant deviation from the provisions of the Guide for the
      Care and Use of Laboratory Animals
2)  The contents of the PHS Suspension/Noncompliance Report will
      include:
a)  A full explanation of circumstances
b)  Description of corrective action taken
c)  Minority views filed by IACUC
c.  Annual Report
1)  The IACUC Coordinator drafts an annual report that is submitted to
      OLAW, through the IO, at least once every 12 months
2)  The Annual Report to OLAW is due on January 31 and includes
      activities of the previous calendar year. 
d.  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.

2.  USDA
a.  USDA Research Facility Registration
1)  Registration will be updated every 3 years
2)  Forms will be filled out by the DLAR and signed by the IO. Refer to
     USDA web site,
     www.aphis.usda.gov/aphis/ourfocus/animalwelfare/SA_Obtain_
     Research_Facility_Annual_Report
3.  USDA form #7011 will be submitted by the IO to APHIS via the Western
     Regional Director of Animal Care (AC)
b.  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.
c.  Annual Report
1)  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).
2)  The Annual Report is prepared by the IACUC Coordinator and signed
      by the IO.
d.  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.
3.  AAALAC
a.  Program Description
1)  Triennial submission as directed by AAALAC prior to site visit
2)  Written by the IACUC Coordinator and reviewed by the IACUC and
      IO.
3)  The Institutional AAALAC Correspondent will send the Program
      Description to the Senior Director, AAALAC International. Currently,
      the IACUC Coordinator is the Institutional AAALAC Correspondent.
b.  Annual Report
Written by the IACUC Coordinator to the President, Council on Accreditation, through the IO
c.  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
d.  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.