Office of Regulatory Affairs, Duties & Functions
- Advises and assists the Commissioner and other key officials on regulations and compliance-oriented matters that have an impact on Policy development and execution, and long-range program goals.
- Coordinates, interprets, and evaluates the Agency's overall compliance efforts; as necessary, establishes compliance policy or recommends policy to the 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 voluntary and regulatory compliance and Agency responsiveness to consumer needs.
- Evaluates and coordinates all proposed legal actions to ascertain compliance with regulatory policy and enforcement objectives.
- Executes direct line authority over all Agency field operations, develops, issues, approves, or clears proposals and instructions affecting field activities; serves as the central point within the Agency through which Headquarters offices obtain field support services.
- Provides direction and counsel to Regional Food and Drug Directors in the implementation of policies and operational guidelines that form the framework for management of Agency field-activities.
- Develops, and/or recommends to the Commissioner policy, programs, and plans for activities between the Agency and State and local agencies; administers the Agency's overall Federal-State program and policy, coordinates the program aspects of Agency contracts with State and local counterpart agencies.
- Evaluates the overall management and capabilities of the Agency's field organization; initiates action to improve the management of field activities and coordinates the formulation and management of career development plans.
- Directs and coordinates the Agency's emergency preparedness and civil defense programs.
- Operates the Federal Medical Products Quality Assurance Program for the Agency.