Office of Enforcement, Duties and Functions
- 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.
- Coordinates, interprets, and evaluates the Agency's overall compliance efforts; as necessary, establishes compliance policy and recommends policy to the Associate Commissioner.
- 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.
- Acts as liaison with other Federal agencies on Agency compliance matters and encourages an effective and appropriate balance between voluntary and regulatory compliance.
- Evaluates and coordinates proposed legal actions to ascertain compliance with regulatory policy and enforcement objectives.
- 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.
- Resolves appeals when proposed compliance actions are disapproved by the centers or the Office of the Chief Counsel.
- 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.
- 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.