PART VII – HEADQUARTER’S RESPONSIBILITIES

1. Office of Regulatory Affairs
   1. Division of Compliance Policy
      1. Coordinates compliance policy and guidance development.
      2. Coordinates responses to inquiries regarding agency interpretation of regulations and policy.
      3. Serves as the liaison with other Federal agencies and foreign governments with whom FDA has Memoranda of Agreement or Memoranda of Understanding.
      4. Resolves issues involving compliance or enforcement policy.
      5. Advises and concurs with Centers on recommended administrative and regulatory actions.
      6. Coordinates modifications and future issuance of this compliance program.
   2. Division of Emergency and Investigational Operations
      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.
   3. Division of Field Science
      1. Assigns laboratories for sample analysis and responds to method inquiries (DFS).
2. Centers
   1. Identify the sponsors or CROs to be inspected (including applications for investigational exemptions, and applications for research or marketing permits to be covered), and forward inspection assignments and background data, e.g., protocols, correspondence, and reviewers' concerns, to the field.
   2. Review and make final classifications of EIRs. Conduct follow-up regulatory/administrative actions. Provide the field copies of all correspondence between the sponsor or CRO and FDA. Provide technical guidance and support to the field as needed.