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Division of Compliance Policy, Duties and Functions

  1. Develops, coordinates,and monitors the development of Agency compliance policy for all domestic and imported products regulated by the Agency.
  2. Directs and coordinates the preparation and maintenance of the Compliance Policy Guides Manual.
  3. Reviews all Agency compliance programs for adherence to established compliance policies. Recommends approval or provides Office of Enforcement concurrence on the programs.
  4. Reviews all Agency planned regulatory initiatives associated with the regulatory planning process to determine the need for an enforcement strategy. Reviews and makes recommendations to the Director, Office of Enforcement, concerning the adequacy of enforcement strategies.
  5. Assures that specific proposed administrative sanctions, such as emergency permits, license suspensions, and revocation of exemptions of antibiotic certification, are appropriately evaluated. Participates with appropriate Agency components in the review of new recall policy issues.
  6. Provides policy and program direction to Agency units carrying out the objectives of the Bioresearch Monitoring Program. Coordinates routine inspectional assignments, monitors compliance activities to assure uniform application of compliance policy, monitors Agency performance in meeting program accomplishment projections for the Bioresearch Program, and evaluates proposed disqualification recommendations of clinical investigators, institutional review boards, and toxicology laboratories.
  7. Acts as the Agency focal point for resolving intra-agency enforcement policy issues. Coordinates and participates with Agency-wide compliance units to monitor and resolve compliance problems and develop approaches to solving regulatory problems.
  8. Serves as a focal point for coordinating FOI activities within ORA; prepares responses to FOI requests; develops guidelines for the field and coordinate field implementation of provisions of the Privacy Act and the Freedom of Information Act.
  9. Manages requests from outside the Agency for testimony of Agency employees. Recommends Agency response.
  10. Provides advice, guidance, and counseling in the planning and implementation of enforcement and evidence development training of Agency personnel, including case development analysis and interpretation of statutes, regulations, and precedent case decisions respecting all laws enforced and/or administered by the Agency.

Page Last Updated: 08/13/2014
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