OFFICE OF REGULATORY AFFAIRS 

          OFFICE OF REGULATORY AFFAIRS

  
a.  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.


b.  Coordinates, interprets, and evaluates the Agency's overall
    compliance efforts; as necessary, establishes compliance
    policy or recommends policy to the Commissioner.


c.  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.


d.  Evaluates and coordinates all proposed legal actions to
    ascertain compliance with regulatory policy and enforcement
    objectives.


e.  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.


f.  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.


g.  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.


h.  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.


i.  Directs and coordinates the Agency's emergency preparedness
    and civil defense programs.


j.  Operates the Federal Medical Products Quality Assurance
    Program for the Agency.





[SMG 1121.1]


[5-1-92]


[No Expiration Date]
[FDA