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U.S. Department of Health and Human Services

About FDA

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Office of Regulatory Affairs, Duties & Functions

 

  1. 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.
  2. Coordinates, interprets, and evaluates the Agency's overall compliance efforts; as necessary, establishes compliance policy or recommends policy to the 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 voluntary and regulatory compliance and Agency responsiveness to consumer needs.
  4. Evaluates and coordinates all proposed legal actions to ascertain compliance with regulatory policy and enforcement objectives.
  5. 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.
  6. 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.
  7. 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.
  8. 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.
  9. Directs and coordinates the Agency's emergency preparedness and civil defense programs.
  10. Operates the Federal Medical Products Quality Assurance Program for the Agency.