BACK
OFFICE OF ENFORCEMENT
Division of Compliance Policy (HFC-230)
- Develops, coordinates,and monitors the development of Agency
compliance policy for all domestic and imported products
regulated by the Agency.
- Directs and coordinates the preparation and maintenance
of the Compliance Policy Guides Manual.
- Reviews all Agency compliance programs for adherence to
established compliance policies. Recommends approval or
provides Office of Enforcement concurrence on the programs.
- 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.
- 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.
- 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.
- 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.
- 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.
- Manages requests from outside the Agency for testimony of
Agency employees. Recommends Agency response.
- 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.
[SMG 1121.23]
[5-12-89]
[No Expiration Date]