Office of Enforcement, Duties and Functions

 

1. Advises and assists the Associate Commissioner and other key officials on regulations and compliance matters that have an impact on policy development, implementation, and long range program goals.
2. Coordinates, interprets, and evaluates the Agency's overall compliance efforts; as necessary, establishes compliance policy and recommends policy to the Associate Commissioner.
3. Stimulates an awareness within the Agency of the need for prompt and positive action to assure compliance by regulated industries; works to assure an effective and uniform balance between regulatory compliance and Agency responsiveness to consumer needs.
4. Acts as liaison with other Federal agencies on Agency compliance matters and encourages an effective and appropriate balance between voluntary and regulatory compliance.
5. Evaluates and coordinates proposed legal actions to ascertain compliance with regulatory policy and enforcement objectives.
6. Directs and coordinates with the Office of Regional Operations (ORO), other Agency components, and Office of the Chief Counsel, new or novel cases which may be precedent setting.
7. Resolves appeals when proposed compliance actions are disapproved by the centers or the Office of the Chief Counsel.
8. Coordinates development of the Agency-wide bioresearch monitoring activities; monitors compliance activities to assure uniform application of compliance policy; serves as liaison with other Federal agencies and outside organizations relating to such Agency wide activates.
9. Serves as the Agency focal point for activities relating to the Federal Medical Products Quality Assurance Program and maintains liaison with other Government agencies procuring medical supplies; issues final administrative approval for quality assurance of specific products and firms.