1-2 - OFFICE OF REGULATORY AFFAIRS (ORA)

1-2-1 - Associate Commissioner For Regulatory Affairs (ACRA)

ORA is under the direction of the Associate Commissioner for Regulatory Affairs.  The ACRA reports directly to the Commissioner of Food and Drugs.

1. The Immediate Office Of The ACRA Includes The: 
   1. Deputy Associate Commissioner for Field Operations, who oversees the operation of the regional offices, district offices, and laboratories; 
   2. Deputy Associate Commissioner for Compliance Policy, who ensures that ORA’s programs and operations support the agency’s public health and consumer protection missions, and leads efforts to develop and implement risk-based approaches to optimize, and maximize the impact of, ORA’s programs and activities; and,
   3. Executive Operations Staff develops and maintains effective channels of internal and external communication of issues of significant visibility and importance on behalf of ORA; tracks, directs and controls development, coordination and, when appropriate, prepares important and sensitive ORA responses to executive and Congressional requests; and serves as ORA’s liaison to the Office of Legislation, the FDA Office of the Executive Secretariat, and center counterparts.
      
      
2. The Following Offices Report To The ACRA:
   1. Office of Resource Management;
   2. Office of Criminal Investigations; and,
   3. Executive Operations Staff.
      
      
3. The Following Offices Report To The Deputy Associate Commissioner for Field Operations:
   
   1. Office of Regional Operations;
      
   2. Regional Field Offices
      
      1. Central Region;
      2. Northeast Region;
      3. Pacific Region;
      4. Southeast Region; and,
      5. Southwest Region.
         
         
4. The Following Offices Report to the Deputy Associate Commissioner for Compliance Policy:
   
   1. Office of Enforcement
      
      
5. The Functional Statements For ORA Are:
   
   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 ensure compliance by regulated industries; works to ensure 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 (RFDDs) 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; and,
   10. Operates the Federal Medical Products Quality Assurance Program for the agency.

Page Top

1-2-2 - Office Of Enforcement (HFC-200)

There are three divisions within the Office Of Enforcement (HFC-200):

1.  Division of Compliance Management and Operations (HFC-210);

2.  Division of Compliance Policy (HFC-230); and, 

3.  Division of Compliance Information and Quality Assurance (HFC-240).

The functional statements for the Office of Enforcement and the three divisions within this office are found in the following Staff Manual Guides:  SMG 1121.20 (Office of Enforcement); SMG 1121.22 (Division of Compliance Management and Operations); SMG 1121.23 (Division of Compliance Policy); and SMG 1121.24 (Division of Compliance Information and Quality Assurance). 

Page Top

1-2-3 - ORA Field Organization

The ORA field organization is divided into regional offices.  The regional offices are under the direction of Regional Food and Drug Directors (RFDDs) who report to the ACRA.  There are five regional offices. They are located as follows:

1. Northeast Region: Jamaica, NY;
2. Central Region: Philadelphia, PA;
3. Southeast Region: Atlanta, GA;
4. Southwest Region: Dallas, TX; and,
5. Pacific Region: Oakland, CA.

There are two to seven district offices within each region for a total of 19 districts.  Each district office is usually comprised of three to four branches, including either a compliance branch or an enforcement branch, which is the primary regulatory contact within a district office.

Page Top