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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Compliance Program 7348.809 - Part VII - Headquarters Responsibilities

  1. CENTERS

    Each Center:
    1. Identifies Institutional Review Boards to be inspected and forwards inspection assignments and background material (e.g., protocols, correspondence, complaint, and Center concerns) to the Director-Investigations Branch, District’s BIMO Coordinator, and FACTS.
    1. Reviews and makes final classifications of EIRs, and enters the classification into FACTS. 
    1. Issues correspondence to the inspected institution after EIR review.  This letter will typically be addressed to the most responsible individual in the institution along with a copy to the IRB chairperson and will state the Center’s assessment of the IRB’s performance.  Copies of letters will be sent to the appropriate District Office.
    1. Conducts follow-up regulatory and/or administrative actions.  Promptly provides copies of relevant correspondence between the institution or IRB and FDA to the field offices.
    1. Provides expert technical guidance, advice, information, interpretation, analysis, and support related to implementation of the clinical BIMO Program for internal and external constituents.

 

  1. DIVISION OF COMPLIANCE POLICY/OE/ORA (HFC-230)
    1. Provides policy and program guidance to agency units who carry out the BIMO Program.
    1. Monitors compliance activities to assure uniform application of compliance policy and agency performance in meeting program accomplishment projections for the BIMO Program.
    1. Resolves issues involving compliance or enforcement policy.

 

  1. DIVISION OF COMPLIANCE MANAGEMENT AND OPERATIONS/OE/ORA (HFC-210)
    1. Serves as the Agency clearance point and coordinator for inspection warrants.
    1. For disqualification actions, reviews and issues the letter with the signature of the Associate Commissioner for Regulatory Affairs (ACRA), and coordinates actions related to the IRB or IRB’s parent institution initial response.

     

  1. DIVISION OF DOMESTIC FIELD INVESTIGATIONS/ORO (HFC-130)
    1. Provides inspection quality assurance, training of field personnel, and operational guidance.
    1. Maintains liaison with Centers and Field Offices and resolves operational questions.
    1. Coordinates and schedules independent and team inspections.

 

  1. OFFICE OF GOOD CLINICAL PRACTICE, OFFICE OF THE COMMISSIONER
    1. Coordinates crosscutting clinical BIMO program activities including modifications of this compliance program.
    1. Provides expert technical guidance, advice, information, interpretation, and analysis relevant to clinical BIMO Program implementation to internal and external program constituents to assure program consistency.
    1. Serves as agency liaison to other Federal Agencies (e.g., OHRP, VA) for coordination of clinical BIMO and human subject protection issues.