Inspections, Compliance, Enforcement, and Criminal Investigations

SUBCHAPTER 1.9 - OFFICE OF REGULATORY AFFAIRS

Table of contents

1.9.1 - OFFICE OF REGULATORY AFFAIRS

The Office of Regulatory Affairs (ORA) is responsible for the operational activities of FDA through the work of its headquarters and field staff. As of December 2012, there were over 4,400 ORA employees. For ORA field contact information, see the ORA Contacts Directory at the end of this manual. ORA is under the leadership of an Associate Commissioner known as the ACRA.

ORA employees are dispersed throughout the United States. Over 85 percent of ORA’s staff works in 5 Regional Offices, 20 District Offices, 13 Laboratories, and more than 150 Resident Posts and Border Stations. ORA Headquarters is comprised of the Office of the Associate Commissioner for Regulatory Affairs; Office of Resource Management; Office of Communications and Quality Program Management; Office of Policy and Risk Management; Office of Partnerships; Office of Operations; Office of Enforcement and Import Operations; Office of Food and Feed Operations; Office of Medical Products and Tobacco Operations; and the Office of Regulatory Science located in either Rockville or Silver Spring, Maryland and the Office of Criminal Investigations located throughout the U.S. FDA maintains Offices and staff in Washington, D.C., the U.S. Virgin Islands, Puerto Rico, and in all States except Wyoming.

1.9.2 - ORA HEADQUARTERS ORGANIZATION

1.9.2.1 - OFFICE OF THE ASSOCIATE COMMISSIONER FOR REGULATORY AFFAIRS (OACRA)

The Office of the ACRA (OACRA) executes direct line authority over all Agency field operations; serves as the central point within the Agency through which Headquarters’ offices obtain field support services. The OACRA advises Agency officials on regulations and compliance-oriented matters that have an impact on policy development and execution and long-range program goals.

Executive Secretariat Staff (ESS)

The Executive Secretariat Staff responds to a broad range of inquiries to ORA, including written and telephone inquiries from consumers, industry representatives, government officials, health professionals, and academia. ESS coordinates and prepares ORA responses to executive and Congressional requests and serves as the ORA liaison with the Office of Legislation, the FDA Office of Executive Secretariat, and Center counterparts. ESS serves as the focal point for coordinating the Freedom of Information (FOI) activities within ORA.

Information Technology Staff (ITS)

The IT Staff advises the ACRA, Deputy ACRA and other key officials on all matters related to ORA's information technology needs, systems development, and budgetary issues. ITS 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 develops long-range strategic plans for ORA's information technology infrastructure and systems.

1.9.2.2 - Office of Resource Management (ORM)

ORM provides leadership and direction to the Associate Commissioner for Regulatory Affairs, Deputy ACRA and other senior managers and staff on all areas of management, including budget formulation and execution, financial management, management analysis, personnel, safety, and administrative operations. ORM oversees the management of acquisitions and contracts within ORA and the management and coordination of ORA’s role in the FDA User Fee programs. ORM is comprised of three Divisions.

1.9.2.2.1 - Division of Management Operations (DMO)

The Division of Management Operations (DMO) provides leadership and guidance to ORA on all aspects of administrative management operations, physical security, safety management and property management activities in accordance with established guidelines. DMO consists of the following groups:Highlighted to denote updated text

Management Operations and Analysis Group

Facilities Management Group

1.9.2.2.2 - Division of Budget Formulation and Execution (DBFE)

The Division of Budget Formulation and Execution (DBFE) coordinates ORA activities regarding formulation and execution of programs concerning budget and resource requests. DBFE manages and coordinates ORA’s role in FDA User Fee programs. DBFE consists of the following groups:Highlighted to denote updated text

Budget Formulation Group

Budget Execution Group

Contracts & Grants Group

Travel Group

1.9.2.2.3 - Division of Human Resource Development (DHRD)

The Division of Human Resource Development (DHRD) develops and coordinates implementation of policies and procedures for ORA human resource development activities; develops and coordinates implementation of policies and procedures for personnel in State and local counterpart Agencies; identifies training need requirements and develops training plans and arranges and coordinates the development and delivery of training programs. DHRD consists of the following teams:Highlighted to denote updated text

Operations Team

Regulatory and Science Team

Strategic Systems, Distance Learning & Records Team

State Training Team

Certification Team

Career Advancement and Succession Team

Education, Media & Technology Applications Team

FISMA/COOP Team

Food Feed Emergency Response Team

Integrated Food Safety TeamHighlighted to denote updated text

1.9.2.3 - Office of Operations (OO)

The Office of Operations is responsible for the overall ORA field operations programs; providing direction and counsel in the implementation of policies and guidelines that form the framework for management of Agency’s global (domestic, U.S. border/port and international) operational activities. The immediate office also includes an Audit Staff responsible for conducting audits of domestic and international regulatory partners to measure their performance against program standards.

The following four headquarter offices report to the ACO, in addition to the five Regional Offices: OFFO, OMPTO, OEIO, and ORS.

1.9.2.3.1 - OFFICE OF FOOD AND FEED OPERATIONS (OFFO)

The Office oversees the food/feed program investigatory operations including emergency response activities. OFFO coordinates and manages all domestic and foreign field investigatory operations related to foods and feed and serves as the central point for other Headquarters offices to obtain field support services for food and feed activities. OFFO creates, reviews, clears and/or issues field assignments.

1.9.2.3.1.1 - Division of Food Defense and Targeting (DFDT)

DFDT receives and reviews prior notice and intelligence data on food products, including animal feed, which will be imported or offered for import into the U.S. and directs the field and/or the U.S. Customs and Border Protection (CBP) on the appropriate action to take to enforce the Prior Notice regulation. DFDT serves as the liaison with CBP, in the field, providing technical expertise in the inspection, examination and sampling of imported food products, including animal feed, that are held at the ports.

1.9.2.3.1.2 - Division of Food and Feed Program Operations and Inspections (DFFPOI)

The Division serves as the Agency focal point for coordinating, directing, and assisting the field and headquarters (HQ) with domestic and international food and feed investigative activities. DFFPOI serves as operational food and feed liaison to FDA’s foreign offices; serves as the technical point of contact for field food and feed assignments and monitors outcomes of assignments. provides inspectional and technical assistance to FDA’s field and foreign offices. DFFPOI coordinates international food and feed regulatory activities and participates in harmonization efforts with other FDA components and national and international governments; and manages the foreign food and feed inspection cadre. DFFPOI consists of the following branches:Highlighted to denote updated text

Food and Feed Program Operations Branch (FFPOB)

Food and Feed Inspection Branch (FFIB)

Food and Feed Trip Planning Branch (FFTPB)

1.9.2.3.2 - OFFICE OF MEDICAL PRODUCTS AND TOBACCO OPERATIONS (OMPTO)

The Office oversees the medical products and tobacco program investigatory operations. OMPTO coordinates and manages all domestic and foreign field investigatory operations related to medical products and tobaccoHighlighted to denote updated text and serves as the central point for other Headquarters offices to obtain field support services for medical products and tobacco activities. OMPTO creates, reviews, clears and/or issues field assignments.

1.9.2.3.2.1 - Division of Medical Products and Tobacco Program Operations (DMPTPO)

The Division serves as the Agency focal point for coordinating, directing, and assisting the field and Headquarters with domestic and international medical products and tobacco investigative activities including coordinating development of the Agency-wide bioresearch monitoring activities; and managing the Medical Products and Tobacco National Experts Program. DMPTPO serves as operational medical products and tobacco liaison to FDA’s foreign offices; provides inspectional and technical assistance to FDA’s field and foreign offices and participates in harmonization efforts with other FDA components and national and international governments. DMPTPO assists with responses to adverse event reports relative to medical products and drug shortages. Manages the Medical Products and Tobacco National Experts Program and staff may perform medical product and tobacco inspections. DMPTPO consists of the following branches:Highlighted to denote updated text

Medical Products and Tobacco Program Operations Branch (MPTPOB)

Team Biologics Branch (TBB)

1.9.2.3.2.2 - Division of Medical Products and Tobacco Inspections (DMPTI)

The Division serves as the Agency focal point for coordinating, directing, and assisting the field and headquarters (HQ) with domestic and international medical product and tobacco investigative activities; and directs the foreign drug and foreign medical device cadres. DMPTI serves as operational liaison to FDA’s foreign offices; provides inspectional and technical assistance to FDA’s field and foreign offices. DMPTI coordinates international medical product and tobacco regulatory activities and participates in harmonization efforts with other FDA components and national and international governments. DMPTI consists of the following branches:Highlighted to denote updated text

Medical Device and Tobacco Inspection Branch (MDTIB)

Drug Inspection Branch (DIB)

Medical Products and Tobacco Trip Planning Branch (MPTTPB)

1.9.2.3.3 - OFFICE OF ENFORCEMENT AND IMPORT OPERATIONS (OEIO)

The Office advises and assists the Assistant Commissioner for Operations (ACO) and other FDA and ORA senior officials on compliance and enforcement matters that impact on policy development, implementation, and long-range program goal; and provides direction, assistance, management, and oversight of FDA’s field import operations, including investigational and compliance activities. OEIO develops, maintains and serves as subject matter experts on information technology systems built to support compliance and import actions.

1.9.2.3.3.1 - Division of Enforcement (DE)

The Division performs final administrative review of proposed legal actions for sufficiency of evidence and resolves disputes or other problems encountered during case review to assure that Agency decisions are consistent. DE provides guidance for and participates in the development of new, novel, or precedent-setting cases. DE serves as the Agency clearance point and coordinator for all warrants, both administrative and search and seizure. DE serves as the Agency focal point for guidance on recall plans and procedures. DE Directs and coordinates ORA’s activities related to the investigation of health fraud; serves as the health fraud liaison to the Centers; and provides management and oversight of the Agency’s debarment program. DE consists of the following teams:Highlighted to denote updated text

Recall Team

Health Fraud Team

1.9.2.3.3.2 - Division of Import Operations (DIO)

The Division provides direction, assistance, management, and oversight of field import operations, including investigational, compliance and enforcement activities. DIO coordinates Agency import activities with the U.S. Customs and Border Protection (CBP); and oversees FDA’s import filer evaluation program, and associated filer enforcement activities when warranted. DIO consists of the following branches:Highlighted to denote updated text

Import Operations and Maintenance Branch (IOMB)

Import Program Development and Implementation Branch (IPDIB)

1.9.2.3.3.3 - Division of Compliance Systems (DCS)

The Division provides subject matter experts on information technology systems built to support compliance and risk based import entry admissibility decisions. DCS extracts and analyzes data from FDA compliance and import databases to identify and respond to trends of noncompliance. Manages and coordinates the Government-wide Quality Assurance Program and the Federal Medical Products Quality Assurance Program. DCS consists of the following branches:Highlighted to denote updated text

Enforcement Systems Branch (ESB)

Import Compliance Systems Branch (ICSB)

1.9.2.3.4 - OFFICE OF REGULATORY SCIENCE (ORS)

The Office leads the planning, development, and implementation of ORA’s scientific programs including the development, modification, and validation of test methods and measurement techniques, risk assessments and hazard analyses, and generic techniques to enhance public health protection and respond to emergencies. ORS is responsible for budget formulation, execution, and oversight for ORA’s Field Laboratories; manages human and capital resources for the ORA science enterprise; and oversees lab accreditation activities, including proficiency testing for ORA’s laboratories. ORS consists of the following staff:Highlighted to denote updated text

Food and Feed Scientific Staff

Medical Products and Tobacco Scientific Staff

Laboratory Operations and Support Staff

1.9.2.4 - Office of Communications and Quality Program Management (OCQPM)

The Office provides leadership and direction for all ORA internal communications. OCPM oversees project management activities of major ORA-wide or other ACRA-level initiatives following project management best practices. OCQPM manages and maintains the Office of Regulatory Affairs' Quality Management System (QMS). OCQPM consists of the following staff:Highlighted to denote updated text

Quality Management Systems Staff (QMSS)

Project Coordination Staff (OCS)

1.9.2.4.1 - Division of Communication (DC)Highlighted to denote updated text

The Division leads the organization's communications activities and provides strategic counsel and advice to the Office of Regulatory Affairs and agency leadership. This includes preparing, coordinating and developing relevant material in collaboration with other FDA technical, regulatory, and policy units. DC creates and coordinates communications approaches and tools that reach key ORA, cross-agency and external stakeholders. DC develops consistent organizational messaging on key issues, tracks senior leader and employee appearances to outside organizations, provides consultative services for various ORA initiatives, and manages the organizations' Web and digital media presence.Highlighted to denote updated text

Public Affairs & Editorial Staff (PAESB)Highlighted to denote updated text

Web & Digital Media Strategies Branch (WDMSB)Highlighted to denote updated text

1.9.2.5 - Office of Policy and Risk Management (OPRM)

The Office develops, coordinates, and monitors the development of new or modified Agency compliance policies and regulatory procedures for all domestic and imported products regulated by the Agency. OPRM directs and coordinates the preparation and maintenance of compliance type publications including the Compliance Policy Guides Manual and the Regulatory Procedures Manual. In collaboration with the Centers and OCC, establishes Compliance Policy Guides; compliance and enforcement strategies for inclusion in Compliance Programs and develops, clears and issues and/or maintains guidance to the field in the Regulatory Procedures Manual. OPRM plans and directs all risk management activities in the ORA and provides analysis activities for Office and ORA senior management in the development and implementation of risk-based regulatory and enforcement activities. OPRM consists of the following staff:Highlighted to denote updated text

Food and Feed Policy Staff (FFPS)

Medical Products and Tobacco Policy Staff (MPTPS)

Risk Management Staff (RMS)

1.9.2.5.1 - Division of Planning Evaluation and Management (DPEM)

The Division develops and coordinates the implementation of the annual field operational program plans; and analyzes field performance data, evaluates overall field accomplishments in terms of stated goals and resource utilization, and recommends changes in operational program plans and field manpower allocations. DPEM analyzes field performance data, evaluates overall field accomplishments in terms of stated goals and resource utilization; and serves as subject matter experts on the development of information systems related to manpower utilization and data extraction. DPEM develops and maintains domestic and import workload information. DPEM Consists of the following branches:Highlighted to denote updated text

Program Evaluation Branch (PEB)

Work Planning Branch (WPB)

1.9.2.6 - Office of Partnerships (OP)

The Office provides overall agency leadership and guidance in the development, coordination, and evaluation of the agency Federal-State program policy. OP serves as the Agency focal point for coordination with State and local counterpart agencies, including the programmatic administration of contracts and grants; and provides support and logistical functions for FDA’s Regional Specialists in the State Cooperative Programs. OP provides support to states implementing or considering implementation of program standards, such as the Manufactured Food Regulatory Program Standard. OP consists of the following groups and staff:Highlighted to denote updated text

Standards Implementation Staff

Contracts and Grants Staff

1.9.2.7 - Office of Criminal Investigations (OCI)

This office advises and assists the ACRA and other key officials on regulations and criminal violations involving regulated activities and products. OCI directs and conducts criminal investigative activities in coordination with FDA headquarters units and with other Federal, state and local law enforcement agencies. OCI is instrumental in implementing FDA criminal investigation policy, training, and coordination. OCI interfaces directly with Federal and local prosecutorial offices and participates in grand jury proceedings and judicial actions as required. OCI has over 270 employees in headquarters and the field.

1.9.3 - ORA FIELD ORGANIZATION

The ORA field organization is divided into Regional Offices. The Regional Offices are under the control of Regional Food and Drug Directors (RFDDs) who report to the Assistant Commissioner for Operations. There are currently five regional offices which are located as follows:

Northeast
JamaicaHighlighted to denote updated text, NY
Central
Chicago, IL
Southeast
Atlanta, GA
Southwest
Dallas, TX
Pacific
Oakland, CA
 

Each Regional Office directs 2 to 7 District Offices.

There are currently 20 District Offices located in major cities around the country.

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Page Last Updated: 07/28/2015
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