BACK
OFFICE OF ENFORCEMENT (HFC-200)
- 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.
Division of Compliance Management & Operations (HFC-210)
Division of Compliance Policy (HFC-230)
Medical Products Quality Assurance Staff (HFC-240)
[SMG 1121.20]
[5-1-92]
[No Expiration Date]