Reporting Requirements to Regulatory/Certification Authorities

Policies and procedures for the Office for Laboratory Animal Welfare (OLAW) requires that regular submissions be made to keep them informed on the status of animal care and use activities at Saginaw Valley State University. The SVSU 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.

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 Saginaw Valley State University

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 Compliance Officer and Oversight at OLAW (once the assurance number has been issued), 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; and minority views filed by IACUC. 

Annual Report - The IACUC Coordinator drafts the 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 kept in the office of the IACUC Coordinator for a minimum of 3 years.