Inspections, Compliance, Enforcement, and Criminal Investigations
PART VII – HEADQUARTER’S RESPONSIBILITIES
1. Identifies the sponsor/CRO/monitor to be inspected (from applications for investigational exemptions and information in research or marketing permits), and forwards inspection assignments and background data (e.g., protocols, correspondence and Center concerns) to the field.
2. Reviews and makes final classifications of EIRs, and enters the classification into FACTS.
3. Conducts follow-up regulatory/administrative actions. Promptly provides copies of all relevant correspondence between the sponsor/CRO/monitor and FDA to the field offices.
4. Provides expert technical guidance, advice, information, interpretation, analysis, and support related to implementation of the clinical BIMO Program for internal and external constituents.
B. DIVISION OF COMPLIANCE POLICY/ORA (HFC-230)
1. Provides policy and program assistance to agency units who carry out the BIMO Program.
2. Monitors compliance activities to assure uniform application of compliance policy and agency performance in meeting program accomplishment projections for the BIMO Program.
3. Resolves issues involving compliance or enforcement policy.
4. For implementation of AIP, reviews and comments on draft letters invoking AIP for ORA.
C. DIVISION OF COMPLIANCE MANAGEMENT AND OPERATIONS/ORA (HFC-210)
1. Serves as the Agency clearance point and coordinator for inspection warrants.
D. DIVISION OF DOMESTIC FIELD INVESTIGATIONS/ORO (HFC-130)
1. Provides inspection quality assurance, training of field personnel, and operational guidance.
2. Maintains liaison with Centers and Field Offices and resolves operational questions.
3. Coordinates and schedules joint Center and multi-District inspections.
E. DIVISION OF FOREIGN FIELD INVESTIGATIONS/ORO
1. Coordinates and schedules foreign inspections.
2. Maintains liaison with Centers and Field staff and resolves operational questions regarding foreign inspections.
F. DIVISION OF FIELD SCIENCE/ORO (HFC-140)
1. Assigns laboratories for sample analysis and responds to inquiries about analytical methods.
G. OFFICE OF GOOD CLINICAL PRACTICE, OC
1. Coordinates crosscutting clinical BIMO Program activities, including modifications of this Compliance Program.
2. 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.
3. Serves as Agency liaison to other Federal Agencies (e.g., OHRP, VA) for coordination of clinical BIMO and human subject protection issues.