PART VII - HEADQUARTERS RESPONSIBILITIES

After review of EIRs containing findings of a serious nature the Centers will initiate necessary action with notification to the Division of Compliance Policy.

Potentialregulatory/administrative approaches are discussed in PART V.

The Center will inform the field via copies of letters or reviewer's memo of the Center classification. Optionally a special memo may be generated. * HFC-130 and HFC-230 should receive copies of correspondence from all OAI classifications and when the final classification differs from the initial classification. *

Copies of all correspondence generated by this program should be supplied to the field.

a. Division of Compliance Policy/ORA

Coordinates policy issues.

*Is the liaison* with other Federal Agencies with whom FDA has Memoranda of Agreement or Memoranda of Understanding concerning this program.

Notifies interested governmental third parties whenever a regulatory action is effected against a clinical investigator.

b. Center

Identifies studies to be audited, and develops the inspection assignment package. Assignments issue directly from the Center to the field.

Reviews all EIRs, makes final classifications of EIRs and initiates and follows up on all regulatory action*s*. Reviews and approves prosecution recommendations made by the field.

Supplies to the field copies of all correspondence between the inspected and FDA.

c. Office of Regional Operations (ORO) - Division of * Emergency and Investigational Operations (DEIO) and Division of Field Science *

*1. DEIO:*

Provides inspection quality assurance, training of field personnel, and operational guidance.

Maintains liaison with Centers and Field Offices and resolves operational questions.

Coordinates and schedules joint Center and multi-District inspections.

*2. DFS:*

Assigns laboratories for sample analysis and responds to method inquiries.