CHAPTER 1

REGULATORY ORGANIZATION

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CONTENTS

INTRODUCTION ...........................................................1

SUBCHAPTER - OFFICE OF REGULATORY AFFAIRS (ORA)

Associate Commissioner for Regulatory Affairs  ............................2

Office of Enforcement  ....................................................2

Division of Compliance Management and Operations  .........................3

Division of Compliance Policy .............................................3

Division of Medical Products Quality Assurance  ...........................3

ORA Field Organization  ...................................................4

SUBCHAPTER - CENTER FOR BIOLOGICS EVALUATION AND RESEARCH (CBER)

Office of Compliance  .....................................................4

Division of Case Management  ..............................................4

Division of Regulations and Policy ........................................5

Division of Inspection and Surveillance ...................................5

SUBCHAPTER - CENTER FOR DRUG EVALUATION AND RESEARCH (CDER)

Office of Compliance ......................................................6

Division of Drug Labeling Compliance ......................................6

Division of Manufacturing and Product Quality Control  ....................6

Division of Drug Quality Evaluation .......................................7

Division of Scientific Investigations .....................................7

Division of Regulatory Affairs ............................................7

SUBCHAPTER - CENTER FOR DEVICES AND RADIOLOGICAL HEALTH (CDRH)

Office of Compliance ......................................................8

Division of Program Operations ............................................8

Division of Bioresearch Monitoring ........................................8

Division of Enforcement I .................................................9

Division of Enforcement II ................................................9

Division of Enforcement III ...............................................9

SUBCHAPTER - CENTER FOR FOOD SAFETY AND APPLIED NUTRITION (CFSAN)

Office of Field Programs ........................... ......................9

Division of Enforcement ..................................................10

Division of HACCP Programs ...............................................10

Division of Cooperative Programs .........................................10

Division of Field Program Planning and Evaluation  .......................11

Office of Cosmetics and Colors  ..........................................11

Division of Programs and Enforcement .....................................11

Office of Food Labeling  .................................................11

Division of Programs and Enforcement .....................................11

Office of Plant and Dairy Foods ..........................................11

Division of Programs and Enforcement  ....................................11

Office of Seafood ........................................................12

Division of Programs and Enforcement .....................................12

Office of Special Nutritionals ............................ ..............12

Division of Programs and Enforcement .....................................12

SUBCHAPTER - CENTER FOR VETERINARY MEDICINE (CVM)

Office of Surveillance and Compliance ....................................12

Division of Surveillance .................................................12

Division of Animal Feeds .................................................13

Division of Compliance ...................................................13

Division of Voluntary Compliance and Hearings Development ................13

ENFORCEMENT POLICY DIRECTORY ........................................15

INTRODUCTION

The purpose of this chapter is to provide an overview of the organizational structure of the offices involved in compliance related functions within the Food and Drug Administration. It is not the intent to provide a complete description as a complete description of the FDA's organizational structure and its functional statement are found in various chapters of the FDA Staff Manual Guide (SMG).

This RPM chapter is divided into sections based on major organizational units, and includes a section for all centers and the Office of Regulatory Affairs. An "enforcement policy" directory, has also been provided at the end of the chapter.

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SUBCHAPTER

OFFICE OF REGULATORY AFFAIRS (ORA)

ASSOCIATE COMMISSIONER FOR
REGULATORY AFFAIRS (ACRA)
Ronald G. Chesemore

The Office of Regulatory Affairs is under the direction of Mr. Ronald G. Chesemore, Associate Commissioner for Regulatory Affairs (ACRA). Mr. Gary J. Dykstra is the Deputy Associate Commissioner for Regulatory Affairs. The functional statements for ORA are:

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.

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

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.

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

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.

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.

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 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.

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.

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

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

OFFICE OF ENFORCEMENT (HFC-200) DANIEL L. MICHELS, DIRECTOR

The functional statements for the Office of Enforcement are:

Advises and assists the Associate Commissioner and other key officials on regulations and compliance matters that have an impact on policy development, implementation, and long-range program goals.

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

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 regulatory compliance and Agency responsiveness to consumer needs.

Acts as liaison with other Federal agencies on Agency compliance matters and encourages an effective and appropriate balance between voluntary and regulatory compliance.

Evaluates and coordinates with the Office of Regional Operations (ORO), other Agency components, and Office of the General Counsel, new or novel cases which may be precedent-setting.

Resolves appeals when proposed compliance actions are disapproved by the centers or the Office of the General Counsel.

Coordinates development of the Agency wide bioresearch monitoring activities; monitors compliance activities to assure uniform application of compliance policy; serves as liaison with other Federal agencies and outside organizations relating to such Agency wide activities.

Serves as the Agency focal point for activities relating to the Federal Medical Products Quality Assurance Program and maintains liaison with other Government agencies procuring medical supplies; issues final administrative approval for quality assurance of specific products/firms.

There are three divisions within the Office of Enforcement.

1. Division of Compliance Management and

Operations.

2. Division of Compliance Policy.

3. Division of Medical Products Quality

Assurance.

DIVISION OF COMPLIANCE MANAGEMENT AND OPERATIONS (HFC-210) Vacant, Director

The functional statements for the Division of Compliance Management and Operations are:

The functional statements for the Division of Compliance Management and Operations are:

Reviews and evaluates proposed legal actions to ascertain compliance with enforcement policy, regulatory objectives, jurisdiction, and adequacy of evidence. Reviews the determination that legal action should be initiated and recommends appropriate action.

Determines the final basis on which specific legal actions reviewed are to be recommended. Recommends appropriate action to the Office Director, or acting on behalf of the Office Director, forwards the recommendations to the Office of the General Counsel.

Performs final administrative review of proposed legal actions for sufficiency of evidence and coordinates the acquisition of additional evidence needed through the appropriate centers and field offices.

Resolves disputes or other problems encountered during case review to assure that Agency decisions are consistent.

Provides guidance for and participates in the development of new, novel, or precedent-setting cases; provides counsel to the field on compliance matters; interprets policy and major action decisions and provides guidance on their application.

Provides regulatory guidance and operational management of case work to insure timely input by involved units.

Evaluates terminated legal cases to determine effectiveness in bringing about correction and to evaluate enforcement strategies and evidentiary and other problems; performs trend analysis and identifies actual and potential problem areas; keeps Agency advised as to actions initiated through case news digest.

Serves as focal point for Headquarters/field operational relations on compliance problems.

Participates in the design and implementation of training programs for Headquarters and field compliance personnel.

Serves as the Agency clearance point and coordinator for all warrants, both administrative and search and seizure.

DIVISION OF COMPLIANCE POLICY (HFC-230), David K. Haggard, Director

The functional statements for the Division of Compliance Policy are:

Develops, coordinates, and monitors development of Agency enforcement policy in all domestic and imported products regulated by the Agency.

Directs and coordinates the preparation and maintenance of Compliance Policy Guides Manual.

Reviews all Agency compliance programs for adherence to established compliance policies. Recommends approval or provides Office of Enforcement concurrence on the programs.

Reviews all Agency planned regulatory initiatives associated with the regulatory planning process to determine the need for an enforcement strategy. Reviews and makes recommendations to the Director, Office of Enforcement, concerning the adequacy of enforcement strategies.

Assures that specific proposed administrative sanctions, such as emergency permits, license suspensions, and revocation of exemptions of antibiotic certification, are appropriately evaluated. Participates with appropriate Agency components in the review of new recall policy issues.

Provides policy and program direction to Agency units carrying out the objectives of the bioresearch Monitoring Program. Coordinates routine inspectional assignments, monitors compliance activities to assure uniform application of compliance policy, monitors Agency performance in meeting program accomplishment projections for the Bioresearch Monitoring Program, and evaluates proposed disqualification recommendations of clinical investigators, institutional review boards, and toxicology laboratories.

Acts as the Agency focal point for resolving intra-Agency enforcement policy issues. Coordinates and participates with Agency-wide compliance units to monitor and resolve compliance problems and develop approaches to solving regulatory problems.

Serves as a focal point for coordinating FOI activities within ORA; prepares responses to FOI requests; develops guidelines for the field and coordinates field implementation of provisions of the Privacy Act and the Freedom of Information Act.

Manages requests from outside the Agency for testimony of Agency employees. Recommends Agency response.

Provides advice, guidance, and counseling in the planning and implementation of enforcement and evidence development training of Agency personnel, including case development analysis and interpretation of statutes, regulations, and precedent case decisions respecting all laws enforced and/or administered by the Agency.

DIVISION OF MEDICAL PRODUCTS QUALITY ASSURANCE (HFC-240)

William T. Lampkin, Director

The functional statements for the Division of Medical Products Quality Assurance are:

Develops and maintains liaison with other Government agencies procuring medical products; develops and manages operational agreements and systems; serves as the FDA focal point for all activities relating to the Government-wide quality assurance program.

Receives and processes requests from other Federal agencies for quality assurance support; serves as the final administrative approval authority for quality assurance evaluations of specific products and firms; provides quality assurance evaluation responses to requesting agencies.

Maintains liaison, coordinates, and directs field and Headquarters activities relating to the Government-wide quality assurance program.

Manages the Agency's firm profile system.

Manages the Agency's program for providing drug quality assurance information to States in support of their drug procurement.

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 (RFDD's) who report to the ACRA. There are six regional offices which are located as follows:

1. Northeast Region New York, NY

2. Mid-Atlantic Region Philadelphia, PA

3. Southeast Region Atlanta, GA

4. Midwest Region Chicago, IL

5. Southwest Region Dallas, TX

6. Pacific Region San Francisco, CA

There are three to five district offices within each region for a total of 21 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.

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SUBCHAPTER

CENTER FOR BIOLOGICS EVALUATION AND RESEARCH

(CBER)

OFFICE OF COMPLIANCE (HFM-600)

JAMES C. SIMMONS, DIRECTOR

The functional statements for the Office of Compliance are:

Monitors the quality of marketed biological products through surveillance, inspections, report evaluation and compliance programs, and coordinates testing of marketed products with other components of FDA.

Advises the Center Director and other Agency officials on FDA's regulatory compliance responsibilities for biological products.

Directs and coordinates Center regulation writing activities.

Manages the headquarters biological product inspection program by coordinating with other Center divisions and Agency components inspection surveillance programs and inspection workplans and providing regulatory guidance and administrative support. Participates in prelicense and annual inspections and on ELA/PLA review committees.

Develops compliance standards for biological product industry practices, including Current Good Manufacturing Practice (CGMP) regulations, and ensures their uniform interpretation.

Directs the Center's bioresearch monitoring program, enforcement, and recall programs for biological products.

Identifies problems in biological product regulation, manufacturing, and quality assurance and proposes solutions to these problems.

Develops biological product quality assurance compliance and surveillance programs, coordinates and directs their field implementation, and advises other Center components on these programs.

Provides guidance to Headquarters and field personnel in the development of evidence to support enforcement actions for deviation from the applicable standards.

Serves as the focal point within CBER for surveillance and enforcement policy development.

Evaluates, in coordination with appropriate Agency officials, a firm conformance with CGMP in producing biological products for procurement by Federal and State agencies.

Coordinates all Center field compliance activities, including planning activities and field assignments, with the exception of consumer affairs activities.

Coordinates the Center's export program and serves as the Center's focal point for import issues.

In conjunction with CBER's Training Staff and other training organizations, develops training programs for industry and FDA personnel.

The Office of Compliance has three Divisions:

1. Division of Case Management

2. Division of Regulations and Policy

3. Division of Inspection and Surveillance

DIVISION OF CASE MANAGEMENT (HFM-610), Steven A. Masiello, Director

This division serves as the focal point with CBER and OC for biologics enforcement policy development. The functional statements for the Division of Case Management are:

Responsible for the review and evaluation of all administrative action recommendations including suspension, revocation, and denial of license based on inspectional and investigation findings and recommended civil and criminal cations.

Coordinates support for ongoing litigation and contested cases with the Office of General Counsel and the Department of Justice, including the identification and preparation of expert witnesses and trains and guides OC, CBER and other Agency personnel in terms of necessary evidence in support of administrative and legal actions.

Provides primary support within the Office of Compliance for Agency AD HOC Committee Meetings relating to proposed enforcement action against products, manufacturers or other individuals associated with CBER regulated products.

Develops enforcement standards for direct reference authority to the FDA district offices for issuance of warning letters and reviews and evaluates CBER and field generated recommendations for warning letter issuances for which direct reference authority had not been granted.

Coordinates Center application data integrity activities.

Serves as the Center focal point for contact by other Federal agencies such as the Securities and Exchange Commission concerning enforcement matters, and coordinates regulatory reviews with other Center components as appropriate.

Directs and coordinates the Center review of applications for export of unapproved biological products.

Provides assessment of the compliance status of regulated firm's within CBER's purview.

DIVISION OF REGULATIONS AND POLICY (HFM-630), Steven F. Falter, Director

The functional statements for the Division of Regulations and Policy are:

Prepares notices and proposed and final rules related to the regulation of biological products for publication in the Federal Register.

Coordinates for CBER the review of Federal Register documents prepared by other centers or by other agencies; consolidates CBER comments and represents Center position to originating office.

Provides copies and interpretation of the regulations to persons in the Federal government, the regulated industry and the general public; and maintains historical archives of all Federal Register documents published by CBER.

Advises CBER staff concerning the administrative procedures for rulemaking, guidelines and other policy documents, hearings and delegations of authority.

Prepares advisor opinions and comments in response to requests from other Agency components, industry and trade organizations.

Develops policy in response to emerging or existing issues which affect the products and firms regulated by CBER.

Coordinates with Office of Chief Counsel on initiation and publication of suspension and revocation actions.

DIVISION OF INSPECTIONS AND SURVEILLANCE (HFM-650)

Boyd C. Fogle, Jr., Director

The functional statements for the Division of Inspection and Surveillance are:

Coordinates Center-field relations regarding requests and support and guidance for field investigations, surveillance inspections and development of recommendations for administrative and enforcement actions. Prepares filed inspection workplan regarding resources for blood establishment inspection program.

Develops guidance materials and training programs regarding biological product inspections and regulatory standards to promote industry compliance with legal requirements and for use in training headquarters and field inspection staffs.

Develops new compliance programs, and coordinates the revision of existing compliance programs for the center.

Manages the biological product surveillance activities including health fraud, drug and device product defect reporting, and error and accident reporting. Serves as the Center focal point for receipt and processing of reports of transfusion-related fatalities.

Plans and directs investigation and surveillance assignments in response to reports regarding product defects, adverse reactions and experiences, unlawful promotion and advertising, and allegations of other violative situations. Evaluates inspection and investigation reports, and recommends appropriate regulatory and enforcement action.

Serves as the focal point within CBER and this Office for Voluntary and FDA requested recalls.

Coordinates the review and evaluation of requests from manufacturers for the release of plasma derivatives associated with the use of blood and blood components under or associated with recalls.

Coordinates Office follow-up and response concerning complaints regarding products or studies under IND.

Provides other CBER components with an evaluation of the acceptability of data submitted in support of product applications.

Manages the Bioresearch Monitoring programs for CBER; reviews and evaluates Establishment Inspection Reports.

Provides guidance to industry and government concerning bioresearch monitoring policies and regulations.

Establishes and maintains the inspectional histories of individuals and firms.

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SUBCHAPTER

CENTER FOR DRUG EVALUATION AND RESEARCH (CDER)

OFFICE OF COMPLIANCE (HFD-300) STEPHANIE R. GRAY, DIRECTOR

The functional statements for the Office of Compliance are:

Monitors the quality of marketed drugs through product testing, surveillance, and compliance programs.

Advises the Center Director and other Agency officials on FDA's regulatory responsibilities for drugs.

Directs and coordinates Center regulation-writing activities.

Develops standards for drug industry practices, including Current Good Manufacturing Practice (CGMP) regulations, and ensures their uniform interpretation.

Directs the Center's bioresearch monitoring program for drug products.

Identifies problems in drug regulation, manufacturing, and quality assurance and conducts voluntary compliance programs and studies.

Develops drug quality assurance compliance and surveillance programs; coordinates and directs their field implementation; and advises other Center components on these programs.

Coordinates Center-field relations, provides support and guidance to the field on legal actions, case development and contested cases, and reviews and decides disposition of field submissions involving deviations from standards.

Recommends approval, denial of approval, or revocation of approval of activities that use methadone and other drugs for which treatment standards have been promulgated, taking any appropriate compliance action.

Evaluates, in coordination with appropriate agency regulatory affairs officials, a firm's conformance with CGMP in producing drugs for procurement by Federal and State agencies.

Evaluates, classifies, and recommends drug recalls and provides Center coordination with field recall activities.

Develops and implements policies and procedures in support of Center compendial operations and directs the Compendial Monographs Development and Evaluation Program.

There are five divisions under the Office of Compliance:

1. Division of Drug Labeling Compliance

2. Division of Manufacturing and Product

Quality Control

3. Division of Drug Quality Evaluation

4. Division of Scientific Investigations

5. Division of Regulatory Affairs

DIVISION OF DRUG LABELING COMPLIANCE (HFD-310), Bradford W. Williams, Director

The functional statements for the Division of Drug Labeling Compliance are:

Develops and manages compliance programs for NAS/NRC Drug Efficacy Study Implementation (DESI) announcements, OTC and other drug monographs, and for drugs not covered under specific regulations or announcements.

Evaluates field report submissions and recommendations for compliance actions; recommends and manages case development for drug labeling compliance actions; and assists in contested cases.

Advises and notifies firms of the legal and/or compliance status of their drugs under DESI announcements and OTC and other drug monographs and of their drugs not covered under specific regulations or announcements.

Serves as the Center focal point and works with other Agency components in the development and coordination of compliance activities and the legal status of drug products relating to foods, cosmetics, and devices.

DIVISION OF MANUFACTURING AND PRODUCT QUALITY CONTROL (HFD-320)

Douglas I. Ellsworth, Director

The functional statements for the Division of Manufacturing and Product Quality Control are:

Develops and directs Center drug product quality enforcement programs. Develops Agency compliance policy for enforcement of the law regarding drug product quality.

Processes regulatory actions involving drug product quality requirements, and supports litigation arising form regulatory actions.

Serves as Agency focal point regarding compliance of establishments and products with current good manufacturing practices(CGMP) and other drug product quality requirements of the law.

Develops guidance materials and educational programs to promote compliance with drug product requirements.

DIVISION OF DRUG QUALITY EVALUATION (HFD-330), Charma A. Konnor, Director

The functional statements for the Division of Drug Quality Evaluation are:

Develops and directs drug quality evaluation programs, including surveillance and mandatory and voluntary drug certification; coordinates with other compliance divisions as necessary.

Monitors and evaluates nationwide drug product quality through the development and maintenance, in coordination with Center systems design specialists, of information systems containing data about drug products and manufacturers and problems that occur with both.

Evaluates drug product quality data for trends and other uses and identifies new areas for potential Agency responsibility or action.

Directs such field actions as investigations and inspections in response to problems identified by drug quality evaluation programs; recommends, directs, or coordinates case development and compliance activities resulting from these actions.

Coordinates with other Center components to exchange drug quality data and advise them on drug quality evaluation programs.

Coordinates resolution of compendial issues between FDA and the pharmacopeial organizations.

Monitors and coordinates development of new compliance programs and revision of existing compliance programs for the Center.

Directs the FDA Drug Product Listing and Establishment Registration program.

DIVISION OF SCIENTIFIC INVESTIGATIONS (HFD-340), Frances O. Kelsey, M.D., Director

The functional statements for the Division of Scientific Investigations are:

Implements the Agency's Bioresearch Monitoring Program for Human Drugs and Drug Abuse Treatment Monitoring Program under the Federal Food, Drug, and Cosmetic Act, Public Health Service Act, other Federal statutes, and applicable regulations.

Develops standards for the conduct of preclinical and clinical investigations performed to demonstrate the safety and effectiveness of drugs.

Designs and operates surveillance and compliance programs in the areas of preclinical and clinical drug product investigations and methadone monitoring.

Assigns, directs, and coordinates onsite inspections of sponsors and investigators of preclinical and clinical drug product studies, institutional review committees, and commercial clinical testing facilities in collaboration with the Agency's field organization. Evaluates investigation reports and initiates administrative and regulatory corrective measures as necessary.

Recommends approval, denial of approval, or revocation of approval of programs that use methadone and other drugs for which treatment standards have been promulgated; assigns and directs inspections of such programs to determine compliance with standards and regulations; and takes appropriate action when such activities are not in compliance with regulations.

DIVISION OF REGULATORY AFFAIRS (HFD-360), Albert Rothschild, Director

The functional statements for the Division of Regulatory Affairs are:

Advises and assists the Center on regulatory matters; interprets the scop, applicability, and intent of the Federal Food, Drug, and Cosmetic (FD&C) Act, other laws, and proposed and published regulations and policy statements of the Center.

Develops, and/or reviews, all new and revised regulations, guidelines and Federal Register notices for the Center. Evaluates effectiveness of existing regulatory policies and initiates new policies.

Serves as the Center's focal point for responsibilities relating to proposals for new or revised legislation, advisory opinions, and petitions. Develops regulatory policies and programs in response to communications from Congress, consumers, professionals, foreign groups, and other Agency components.

Provides coordination and guidance and develops necessary additional support for regulatory actions that are contested, including legal proceedings and administrative hearings.

Plans and manages consumer, professional and international activities for the Center. Prepares, develops, and coordinates Center and Agency responses to inquiries on drug products from health professionals, consumers, and others.

Develops and manages assessments, strategies, and reports required by executive orders and policies of the Department or Agency relating to regulatory activities.

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SUBCHAPTER

CENTER FOR DEVICES AND RADIOLOGICAL HEALTH (CDRH)

OFFICE OF COMPLIANCE (HFZ-300) LILLIAN J. GILL, DIRECTOR

The Office of Compliance (OC) develops, directs, coordinates, evaluates, and monitors compliance programs covering regulated industry. OC conducts field tests and inspections when necessary for regulatory purposes, evaluates industry quality control and testing programs to assure compliance with regulations, and provides advice to Agency field offices on, and manages Center activities relating to, legal actions, case development, and contested case assistance, and coordinates all field planning activities and issues all field assignments for the Center.

There are five divisions in the Office of Compliance:

1. Division of Bioresearch Monitoring

2. Division of Program Operations

3. Division of Enforcement I

4. Division of Enforcement II

5. Division of Enforcement III

DIVISION OF PROGRAM OPERATIONS (HFZ-305) Karen Moss, Director

The functional statements for the Division of Program Operations are:

Advises and supports Office officials and staff regarding all policies and procedures relating to administrative support activities.

Advises Office officials and staff regarding management information system initiatives and serves as the Office liaison to other Center and Agency components on all such matters. Plans, coordinates, and implements office automation within the Office.

Provides information for requests from external as well as internal sources. Coordinates and processes Freedom of Information Requests (FOI) and issues certificates for requests to export approved medical devices and non-approved medical devices under 801(e) of the Federal Food, Drug and Cosmetic Act.

Coordinates the Center's administrative activities with field offices as well as internal regulatory actions.

Develops, coordinates, and/or conducts medical device and electronic products training programs for field personnel and State and local agencies in coordination with other Center and Agency components.

Develops, processes information for, and maintains the medical device registration and product listing system; develops and monitors contracts for data processing; ensures industry compliance with reporting requirements through a certification program; and develops and maintains a document tracking system.

There are two branches within this division.

1. Field Programs Branch.

2. Information Processing & Office Automation

Branch.

DIVISION OF BIORESEARCH MONITORING (HFZ-310) Mary Lyda, Acting Director

The functional statements for the Division of Bioresearch Monitoring are:

Enforces the Medical Device Amendments of 1976 and the Safe Medical Devices Acts of 1990 and 1992 as they relate to investigational devices.

Manages and coordinates the administrative and regulatory responsibilities of the Agency's Bioresearch Monitoring Program for medical devices. Prepares related warning letters and other correspondence. Ensures corrective actions taken by firms inspected under the Bioresearch Monitoring Compliance Program are acceptable.

Assigns, directs, and coordinates on-site inspections of sponsors and investigators of preclinical and clinical device product studies, institutional review boards, commercial clinical testing facilities, and nonclinical toxicology laboratories in collaboration with the Agency's field organization.

Provides regulatory guidance and interpretations of the informed consent, institutional review board, and the investigational device exemption regulations to the field and industry.

Designs, implements, and evaluates surveillance and compliance programs in the areas of preclinical and clinical investigational device product investigations. Manages the premarket approval data audit program to ensure the integrity of data submitted to the Agency.

Coordinates and implements the Agency's Application Integrity Policy for medical devices.

There are two branches within this division.

1. Program Enforcement Branch I.

2. Program Enforcement Branch II.

DIVISION OF ENFORCEMENT I (HFZ-320) Adrianne Galdi, Director

Enforces medical device regulations as they relate to in vitro diagnostics, diagnostic devices, and general surgery devices.

There are three branches within this division.

1. In Vitro Diagnostic Branch.

2. Diagnostic Devices Branch.

3. General Surgical Devices Branch.

DIVISION OF ENFORCEMENT II (HFZ-330) Steve Niedelman, Director

Enforces medical device regulations as they relate to dental; ear, nose, and throat (ENT); ophthalmic; urology, gastroenterology; general hospital; obstetrics/gynecology (OB/GYN); and therapeutic radiographic devices.

There are three branches within this division.

1. Dental, ENT, and Ophthalmic Devices

Branch.

2. OB/GYN, Gastroenterology, Urology Devices

Branch.

3. General Hospital and Therapeutic

Radiographic Devices Branch.

DIVISION OF ENFORCEMENT III (HFZ-340) Vacant, Director

Enforces medical device regulations as they relate to cardiovascular, non-medical radiological, orthopedic, physical medicine, anesthesiology, and neurology devices.

There are three branches within this division.

1. Cardiovascular and Neurological Devices

Branch.

2. Orthopedic, Physical Medicine, and

Anesthesiology Devices Branch.

3. Non-Medical Radiological Devices Branch.

The functional statements for the Division of Enforcement I, II, and III, as they relate to each division's specialty areas, are:

Manages and coordinates activities associated with administrative and regulatory actions.

Develops, interprets, and issues policy guidance in response to specific requests from the medical device and electronic product industries, trade associations, other Federal agencies, other countries, State agencies, and the general public. Develops, review, and revises new and amended regulations including good manufacturing practices (GMPs) and standards for electronic products.

Plans, initiates, coordinates, and conducts medical device and electronic product inspections and investigations of manufacturers and their products. Reviews and evaluates design, test, and production data and reports from manufacturers to ensure compliance with promulgated standards and regulations.

Identifies the need for and directs the development of Compliance Policy Guides and programs to facilitate compliance by manufacturers. Develops, coordinates, reviews, and revises medical device industry GMP regulations. Develops and implements programs to ensure uniform interpretation and application of GMPs and recommends regulatory action when appropriate.

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SUBCHAPTER

CENTER FOR FOOD SAFETY & APPLIED NUTRITION (CFSAN)

OFFICE OF FIELD PROGRAMS (HFS-600) CARL REYNOLDS, DIRECTOR

The functional statements for the Office of Field Programs are:

Serves as the focal point between the Center and the field.

Coordinates with Center program offices and the Office of Regional Operations in Developing and implementing field programs. Evaluates field accomplishments and provides feedback to Center and field management.

Reviews proposed recalls and regulatory actions for adequacy of evidence and consistency across programs; and coordinates with and refers cases to the appropriate program offices for policy and technical review.

Plans and develops approaches to implement regulatory responsibilities in interstate travel sanitation.

Publishes and promotes sanitation standards for regulating food service, food stores, and food vending operations and the milk industry. Provides information, training, and technical assistance to implement such standards.

Coordinates with the States on the National Shellfish Sanitation Program and evaluates State programs.

Conducts a national certification program for laboratories testing dairy products and other foods.

Develops and supports the implementation of Hazard Analysis Critical Control Point (HACCP) programs in the production and processing of foods. Provides technical evaluations to support regulation of low-acid, thermally processed foods.

There are four divisions within the Office of Field Programs.

1. Division of Enforcement.

2. Division of HACCP Programs.

3. Division of Cooperative Programs.

4. Division of Field Program Planning and

Evaluation

DIVISION OF ENFORCEMENT (HFS-605)

Vacant, Director

The functional statements for the Division of Enforcement are:

Evaluates and recommends solutions to compliance problems involving foods, cosmetics, pesticides, and food chemicals.

Reviews proposed recalls and regulatory actions for adequacy of evidence and consistency across programs; and coordinates with and refers cases to the appropriate program offices for policy and technical review.

Develops and maintains procedures when authority for direct case handling has been delegated to the field.

Manages the development of controversial, precedent-setting, and contested court cases and provides guidance and technical support as necessary.

Provides oversight for the import foods program.

There are two branches within the Division of Enforcement.

1. Import Branch.

2. Case Processing Branch.

DIVISION OF HACCP PROGRAMS (HFS-615) Dennis Dignan, Acting Director

The functional statements for the Division of HACCP Programs are:

Establishes FDA Hazard Analysis Critical Control Point (HACCP) concepts and policy regarding HACCP programs.

Develops model/generic HACCP systems and plans, implements HACCP pilot programs in conjunction with the food industry and/or trade associations.

Coordinates FDA field and/or industry HACCP initiatives and systems.

Conducts a national certification program for State laboratories testing dairy products and other foods.

Standardizes, evaluates and certifies State and territorial milk laboratory evaluation officers.

Provides consultation to FDA, and outside organizations on laboratory equipment, apparatus, methods, and facilities problems associated with laboratory examination of foods.

Conducts and/or participates in the preparation of FDA and/or State milk and food seminars, conferences, workshops, and training courses on laboratory methodology.

Supports the Low Acid Canned Food (LACF) regulations by filing, reviewing, and registering, LACF processes.

Provides technical evaluation of thermal processing equipment and potential public health sterilization process delivery problems and deviations from low-acid canned food regulations. Recommends regulatory action when appropriate.

There are two branches within this division.

1. Laboratory Quality Assurance Branch.

2. Regulatory Food Processing and Technology

Branch.

DIVISION OF COOPERATIVE PROGRAMS (HFS-625) William Carter, Acting Director

The functional statements for the Division of Cooperative Programs are:

Promotes sanitation standards in the form of model ordinances for regulating food service, food store and food vending operations, shellfish, and the milk industry.

Cooperates with health industry standards writing groups that produce milk and food equipment design and construction standards.

Provides information, training, and technical assistance to Agency and outside organizations on code interpretation, compliance procedures, and problem solving to maintain uniform Agency-developed standards of sanitation for the retail food and milk industries.

Plans and coordinates, with the Office of Regulatory Affairs, field activities relating to the accomplishment of compliance program requirements, decisions on requests for special investigations, and the planning and surveillance of food operations in Federally-managed locations.

Coordinates with the States on the National shellfish Sanitation Program and evaluates State programs.

Plans and develops approaches to implement regulatory responsibilities in interstate travel sanitation.

There are three branches within this division.

1. Milk Safety Branch.

2. Retail Food Protection Branch.

3. Shellfish Program Implementation Branch.

DIVISION OF FIELD PROGRAM PLANNING AND EVALUATION (HFS-635)

Lee Bowers, Director

The functional statements for the Division of Field Program Planning and Evaluation are:

Coordinates with the CFSAN program offices, compliance programs and assignments for the implementation by the field. Acts as liaison with the Office of Regulatory Affairs to assure that CFSAN's program proposals are acceptable and reflect current policy.

Monitors and summarizes field accomplishments to effect correction or completion of activities and provide feedback to the CFSAN program offices, Center management, and ORA.

Provides CFSAN management with recommendation regarding field resource needs and reallocation proposals in order to accomplish high priority CFSAN activities and prepares field resource allocation for CFSAN programs.

There are two branches within this division.

1. Domestic Programs Branch.

2. Import Programs Branch.

OFFICE OF COSMETICS AND COLORS

(HFS-100) JOHN BAILEY

ACTING DIRECTOR (OCC)

DIVISION OF PROGRAMS AND ENFORCEMENT POLICY (HFS-105) Raymond Decker, Director

Develops regulations, compliance policy, position papers, regulatory guidelines, and advisory opinions on issues related to cosmetic ingredients and products, color additive certification, color additive diluents, and products containing color additives.

Reviews proposed regulatory actions referred by the Office of Field Programs for program policy consideration and provides technical evaluation on cases related to OCC.

Serves as the Agency focal point for the development and evaluation of programs and the implementation of the laws and regulations related to OCC.

Manages the review of petitions and evaluates and prepares the necessary action on petitions submitted to the Agency related to the functions of OCC.

Administers the Agency's Color Certification and Cosmetic Registration programs.

There are two branches within this division.

1. Cosmetics Programs and Regulations Branch.

2. Color Certification Branch.

OFFICE OF FOOD LABELING (HFS-150)
F. EDWARD SCARBROUGH, DIRECTOR (OFL)

DIVISION OF PROGRAMS AND ENFORCEMENT (HFS-155]) Elizabeth Campbell, Director

Develops regulations, compliance policy, position papers, regulatory guidelines, and advisory opinions on issues related to food labeling and food standards.

Provides support and guidance to the field in cooperation with the Office of Field Programs, in handling regulatory actions and provides Headquarters assistance in the development, management, and coordination of cases related to this OFL.

Serves as the Agency focal point for the development and evaluation of programs and the implementation of the laws and regulations related to OFL.

Manages the review of petitions and evaluates and prepares the necessary action on petitions submitted to the Agency related to the functions of OFL.

There are two branches within this division.

1. Guidelines and Regulations Branch.

2. Food Standards Branch.

OFFICE OF PLANT AND DAIRY FOODS

AND BEVERAGES (HFS-300)

JOHN VANDERVEEN, DIRECTOR (OPDFB)

DIVISION OF PROGRAMS AND ENFORCEMENT POLICY (HFS-305) Terry Troxell, Director

Develops regulations, position papers, regulatory guidelines, compliance strategies, and advisory opinions on issues related to contemporary food production and packaging techniques and the role of chemical and microbial contaminants in food safety.

Reviews proposed regulatory actions referred by the Office of Field Programs for program policy consideration and provides technical evaluation on cases related to OPDFB.

Serves as the Agency focal point for the development and evaluation of programs and the implementation of the laws and regulations related to OPDFB.

Reviews petitions for implementing action levels set by OPDFB.

Serves as the Agency focal point for technical information on agency monitoring programs and data regarding pesticides residues, industrial chemicals, toxic elements and natural toxins in foods.

There are two branches within this division.

1. Regulations and Enforcement Branch.

2. Contaminants Standards Monitoring and

Programs Branch.

OFFICE OF SEAFOOD (HFS-400)

PHILIP SPILLER, ACTING DIRECTOR (OS)

DIVISION OF PROGRAMS AND ENFORCEMENT POLICY (HFS-415), Richard Dees, Director

Develops regulations, compliance policy, position papers, regulatory guidelines, and advisory opinions on issues related to seafood.

Reviews proposed regulatory actions referred by the Office of Field Programs for program policy consideration and provides technical evaluations on cases related to OS.

Serves as the Agency focal point for the development and evaluation of programs, for the development of Agency seafood resource allocation recommendations, and the implementation of the laws and regulations related to OS.

Reviews petitions for implementing action levels set by OS.

There are two branches within this division.

1. Policy Guidance Branch.

2. Program and Enforcement Branch.

OFFICE OF SPECIAL NUTRITIONALS

(HFS-450) ELIZABETH YETLEY, DIRECTOR (OSN)

DIVISION OF PROGRAMS AND ENFORCEMENT POLICY (HFS-455) Victor Frattali, Director

Develops regulations, compliance policy, position papers, regulatory guidelines, and advisory opinions on issues related to special nutritional foods, including but not limited to infant formulas, dietary supplements, and medical foods.

Reviews proposed regulatory actions referred by the Office of Field Programs for program policy consideration and provides technical evaluations on cases related to OSN.

Serves as the Agency focal point for the development and evaluation of programs and the implementation of the laws and regulations related to OSN.

Manages the review of petitions and evaluates and prepares the necessary action on petitions submitted to the Agency related to the function of OSN.

Develops and evaluates appropriate methods of nutrient analysis for special nutritionals.

There are two branches within this division.

1. Regulatory Branch.

2. Methods Research Branch.

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SUBCHAPTER

CENTER FOR VETERINARY MEDICINE (CVM)

OFFICE OF SURVEILLANCE AND COMPLIANCE (HFV-200), GEORGE A. MITCHELL, DVM, DIRECTOR

The functional statements for the Office of Surveillance and Compliance are:

Advises the Center Director on surveillance and compliance policy concerning FDA regulatory responsibility with respect to animal drugs, feeds, feed additives, veterinary medical devices, and other veterinary medical products.

Plans, develops, monitors, and evaluates Center surveillance and compliance programs and coordinates their field implementation to ensure the safety and effectiveness of marketed animal drugs, feeds, feed additives, veterinary medical devices, and other veterinary medical products.

Directs and coordinates the development of scientific evidence supporting Formal Evidentiary Hearings requested by the Center.

Recommends to the Center Director the amendment or withdrawal of approved new animal drugs applications.

Develops, coordinates, and directs the Center's Voluntary compliance Program and the Bioresearch Monitoring Program.

Prepares regulations and other Federal Register notices, and review and acts on regulatory action recommendations.

The four divisions in this office are:

1. Division of Surveillance

2. Division of Animal Feeds

3. Division of Compliance

4. Division of Voluntary Compliance and

Hearings Development

DIVISION OF SURVEILLANCE (HFV-210)

William C. Keller, DVM, Director

The functional statements for the Division of Surveillance are:

Evaluates the safety and effectiveness of marketed animal drugs, special dietary feeds, veterinary medical devices, and other veterinary medical products and recommends action to correct deficiencies resulting form inadequate directions for use, warnings, and cautionary information.

Provides veterinary medical support for regulatory actions an obtains expert witnesses.

Reviews and makes recommendations concerning label revisions, regulatory supplements, and withdrawal of approval of new animal drugs.

Monitors and evaluates advertising and labeling of marketed veterinary drugs and devices to determine veracity of claims

Conducts continuing surveillance and veterinary medical evaluations of clinical experience and required reports.

Obtains and evaluates clinical and industry reports of adverse animal drug reactions and reviews consumer and veterinary practitioner complaints and reports.

Reviews and evaluates compliance and surveillance programs covering regulated industries in animal drugs, veterinary medical devices, and other veterinary medical products.

Reviews establishment inspection reports, labeling, and other findings to determine whether animal drugs and veterinary medical devices are being marketed in accordance with the Federal Food, Drug, and Cosmetic Act and Agency regulations and policy.

Recommends and may participate in intramural and extramural research projects to be conducted or coordinated by the Center's Office of Science to gain further information on animal drugs, devices, or other veterinary products.

DIVISION OF ANIMAL FEEDS (HFV-220)

George Graber, Ph.D., Director

The functional statements for the Division of Animal Feeds are:

Evaluates food additive and generally recognized as safe petitions for adequacy of animal and human food safety, environmental and utility data, labeling, and manufacturing facilities and procedures.

Reviews and determines the adequacy of information submitted for proposed use of investigational food additives in all animal species.

Evaluates medicated feed applications to ascertain that feed composition, manufacturing procedures, labeling, and equipment meet specifications for approval of the use of the drug and comply with appropriate Agency regulations.

Evaluates the safety of animal feeds and feed ingredients and recommends Agency programs concerning their adulteration.

Provides medical and scientific opinions on the toxic principles of contaminants of animal feeds for regulatory actions.

Evaluates scientific, manufacturing, and use data and labels on non-drug substances added to animal feed to determine their legal status.

Reviews proposed drug premix, medicated feed,a and pet food labeling and regulations.

Recommends and implements policies and regulations brought about by new information or programs related to animal feeds.

Recommends and may participate in intramural and extramural research projects to be conducted or coordinated by the Office of Science to gain further information on contaminants, drugs, and food additives.

There are two branches within this division.

1. Feed Safety Branch.

2. Petitions Review & Medicated Feeds Branch.

DIVISION OF COMPLIANCE (HFV-230)

Vacant, Director

The functional statements for the Division of Compliance are:

Advises on regulatory and administrative policy issues involving animal drugs, feeds, feed additives, veterinary medical devices, and other veterinary medical products; prepares and issues guidance to the Field Offices.

Coordinates and assigns the investigative and regulatory follow-up of all compliance programs, recalls, and drug residue reports.

Provides support and guidance to the Field/District Offices on regulatory actions and provides Headquarters support in case development, coordination, and litigation assistance.

Reviews proposed regulatory actions submitted by the Field Offices and recommends whether such actions should be pursued further by the Agency.

Coordinates and prepares replies to inquiries from consumers, State and Federal governments, Congress, industry, etc.

Develops, reviews, and coordinates all Federal Register publications pertaining to Center functions.

Manages the Center's Bioresearch Monitoring Program.

Coordinates requests and activities pertaining to the Regulatory Flexibility Act, Executive Orders on Regulations, Paperwork Reduction Act, and regulations planning and implementation.

There are two branches and one staff within this division.

1. Bioresearch Monitoring Program Staff.

2. Case Guidance Branch.

3. Petitions and Regulations Branch.

DIVISION OF VOLUNTARY COMPLIANCE AND HEARINGS DEVELOPMENT (HFV-240)

Linda Tollefson, Ph.D., Director

The functional statements for the Division of Voluntary Compliance and Hearings Development are:

Develops scientific evidence concerning withdrawal/refusal to approve animal drugs and prepares the documentation for a formal evidentiary hearing; prepares the Administrative and Evidentiary Records for a hearing.

Develops, monitors, and evaluates the Center's compliance and surveillance programs pertaining to the regulated industries in animal drugs, feeds, feed additives, medical devices, and other related areas; coordinates the investigative and regulatory follow-up of all compliance programs; coordinates and prepares the annual Field Workplan.

Plans, establishes, coordinates, and reviews voluntary compliance and quality assurance programs designed to increase understanding of the Center's responsibilities in implementing the Federal Food, Drug, and Cosmetic Act and to persuade and motivate communities and industries to accept the Center's self-inspection programs.

There are two branches and one staff within this division.

1. Tissue Residue Branch.

2. Industry Programs Staff.

3. Programs and Hearings Branch.