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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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1-2 - OFFICE OF REGULATORY AFFAIRS (ORA)

1-2 - OFFICE OF REGULATORY AFFAIRS (ORA)
     Associate Commissioner for Regulatory Affairs (ACRA)
     1-2-1 ACRA Organization
     1-2-2 The Immediate Office of the ACRA
     1-2-3 Deputy Associate Commissioner for Regulatory Affairs
     1-2-4 Office of Resource Management
     1-2-5 Office of Operations
     1-2-6 Office of Criminal Investigations
     1-2-7 The Functional Statements for ORA

As a result of the ORA reorganization efforts in 2012, new offices and divisions in ORA headquarters were established with new and combined functions to help support the rapid modernization and globalization of FDA’s regulated products and new legislative authorities provided by Congress.

 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.

 1-2-1 - ACRA Organization

The following offices and senior officials report to the ACRA:

  1. Deputy Associate Commissioner for Regulatory Affairs;
  2. Executive Secretariat Staff;
  3. Information Technology Staff;
  4. External Relations Staff;
  5. Senior Scientist;
  6. Office of Resource Management;
  7. Office of Operations; and,
  8. Office of Criminal Investigations

 1-2-2 - The Immediate Office of the ACRA

The Immediate Office of the ACRA includes the:

  1. Executive Secretariat Staff;
  2. Information Technology Staff;
  3. External Relations Staff; and,
  4. Senior Scientist.

The functional statements for the offices within the ACRA are found in Staff Manual Guides SMG 1121.1a (Office of the Associate Commissioner of Regulatory Affairs).

 1-2-3 - Deputy Associate Commissioner for Regulatory Affairs

The following offices report to the DACRA:

1. Office of Policy and Risk Management

The Office of Policy and Risk Management is comprised of risk, policy Staffs and a Division:

  1. Risk Management Staff;
  2. Food and Feed Policy Staff;
  3. Medical Products and Tobacco Policy Staff; and,
  4. Division of Planning Evaluation and Management.

2. Office of Communications and Quality Program Management

The Office of Communication and Quality Program Management includes the:

  1. Quality Management Staff;
  2. Internal Communications Staff; and
  3. Project Coordination Staff.

3. Office of Partnerships

The Office of Partnerships includes the:

  1. Contracts and Grants Staff; and
  2. Standards Implementation Staff.

The functional statements for the aforementioned offices and division within these offices are found in the following Staff Manual Guides: SMG 1121.70 (Office of Policy and Risk Management); SMG 1121.71 (Division of Planning Evaluation and Management); SMG 1121.50 (Office of Communication and Quality Program Management); and SMG 1121.60 (Office of Partnerships).

 1-2-4 - Office of Resource Management

There are three Divisions within the Office of Resource Management:

  1. Division of Human Resource Development;
  2. Division of Management Operations; and
  3. Division of Budget Formulation and Execution.

The functional statements for the Office of Resource Management and the three divisions within this office are found in the following Staff Manual Guides: SMG 1121.10 (Office of Resource Management); SMG 1121.13 (Division of Human Resource Development); SMG 1121.14 (Division of Management Operations); and SMG 1121.15a (Division of Budget Formulation and Execution).

 1-2-5 - Office of Operations

The following offices and staff report to the Office of Operations:

1. Audit Staff

2. Office of Enforcement and Import Operations
There are three Divisions within the Office of Enforcement and Import Operations:

  1. Division of Enforcement;
  2. Division of Import Operations; and,
  3. Division of Compliance Systems.

3. Office of Food and Feed Operations
There are two Divisions within the Office of Food and Feed Operations:

  1. Division of Food Defense Targeting; and,
  2. Division of Food and Feed Operations and Inspections.

4. Office of Medical Products and Tobacco Operations
There are two Divisions within the Office of Medical Products and Tobacco Operations:

  1. Division of Medical Products and Tobacco Program Operations; and,
  2. Division of Medical Products and Tobacco Inspections.

5. Office of Regulatory Science
There are scientific and support staffs within the Office of Regulatory Science:

  1. Food and Feed Scientific Staff;
  2. Medical Products and Tobacco Scientific Staff; and,
  3. Laboratory Operations and Support Staff.

6. ORA Regions
The ORA field organization is divided into five 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:

  1. Regional Field Office, Northeast Region: Jamaica, NY;
  2. Regional Field Office Central Region: Chicago, IL;
  3. Regional Field Office, Southeast Region: Atlanta, GA;
  4. Regional Field Office, Southwest Region: Dallas, TX; and
  5. Regional Field Office, Pacific Region: Oakland, CA.

There are two to seven district offices within each region for a total of 20 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. Regional Laboratories, Winchester Engineering and Analytical Center, and Forensic Chemistry Center are also part of the ORA Field Offices.

The functional statements for the Office of Operations organizations can be found in the following Staff Manual Guides: SMG 1121.80 (Office of Operations), SMG 1121.81 (Office of Enforcement and Import Operations), SMG 1121.811 Division of Enforcement, SMG 1121.812 (Division of Compliance Systems), SMG 1121.813 (Division of Import Operations), SMG 1121.82 (Office of Food and Feed Operations), SMG 1121.821 (Division of Food Defense Targeting), SMG 1121.822 (Division of Food and Feed Program Operations and Inspections), SMG 1121.83 (Office of Medical Products and Tobacco Operations), SMG 1121.831 (Division of Medical Products and Tobacco Inspections), SMG 1121.832 (Division of Medical Products and Tobacco Program Operations), and SMG 1121.84 (Office of Regulatory Science).

The function statements for the ORA Field Organizations are found at: SMG 1311.1 (Regional Field Office, Northeast Region – Jamaica, NY), SMG 1311.2 (District Office – New York, NY), SMG 1311.4 (District Office – New England), SMG.1311.6 (Northeast Regional Laboratory), SMG 1311.7 (Winchester Engineering and Analytical Center), SMG 1312.1 (Regional Field Office, Central Region – Chicago, IL), SMG 1312.2 (District Office – Baltimore, MD), SMG 1312.3 (District Office – Cincinnati, OH), SMG 1312.4 (Forensic Chemistry Center), SMG 1312.5 (District Office – New Jersey), SMG 1312.6 (District Office – Philadelphia, PA), SMG 1312.7 (District Office – Chicago, IL), SMG 1312.8 (District Office – Detroit, MI), SMG 1312.9 (District Office – Minneapolis), SMG 1313.1 (Regional Field Office, Southeast Region – Atlanta, GA), SMG 1313.2 (District Office – Atlanta, GA), SMG 1313.4 (District Office – Florida), SMG 1313.5 (District Office – New Orleans, LA), SMG 1313.6 (District Office – San Juan, PR), SMG 1313.7 (Southeast Regional Laboratory – Atlanta, GA), SMG 1315.1 (Regional Field Office, Southwest Region – Dallas, TX), SMG 1315.2 (District Office – Dallas, TX), SMG 1315.3 (District Office – Kansas City, MO), SMG 1315.4 (District Office – Denver, CO), 1315.5 (Arkansas Regional Laboratory), SMG 1315.6 (Southwest Import District Office – Dallas, TX), SMG 1316.1 (Regional Field Office Pacific Regional – Oakland, CA), SMG 1316.2 (San Francisco District Office – Alameda, CA), SMG 1316.3 (Los Angeles District Office – Irvine, CA), SMG 1316.4 (Seattle District Office – Bothell, WA), SMG 1316.5 (Pacific Regional Laboratory Southwest – Irvine, CA), and SMG 1316.6 (Pacific Regional Laboratory Northwest – Bothell, WA).

 1-2-6 - Office of Criminal Investigations

The Office of Criminal Investigations includes the:

  1. Office of the Director;
  2. Office of Internal Affairs;
  3. Mid-Atlantic Area Office;
  4. Northeast Area Office;
  5. Southwest Area Office;
  6. Southeast Area Office;
  7. Midwest Area Office; and,
  8. Pacific Area Office.

The functional statements for the Office of Criminal Investigations can be found in the following Staff Manual Guides: SMG 1121.40 (Office of Criminal Investigations).

 1-2-7 - The Functional Statements for ORA

  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 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;
  10. Operates the Federal Medical Products Quality Assurance Program for the agency;
  11. Advises the ACRA on all matters related to ORA’s information technology needs, systems development, and budgetary issues;
  12. Coordinates with staff in ORA offices, regions, districts and laboratories as well as offices and staff external to ORA to develop and evaluate business needs in relation to current and planned information technology systems, and foster relations that facilitate ORA’s IT efforts;
  13. Develops long-range strategic plans for ORA’s information technology infrastructure and systems;
  14. Coordinates programs and procedures to solicit input from end-users throughout ORA to achieve efficiencies within IT systems and to ensure customer needs are met; and,
  15. Evaluates new policies and regulations for impacts to ORA IT systems.