Contents

SUBCHAPTER 270 - OFFICE OF REGULATORY AFFAIRS

270 - ASSOCIATE COMMISSIONER FOR REGULATORY AFFAIRS (HFC-1)

The Associate Commissioner for Regulatory Affairs (ACRA) is John M. Taylor, III and the Deputy Associate Commissioner for Regulatory Affairs is John Marzilli. The Assistant Commissioner for Regulatory Affairs is Steven Niedelman.

ORA is under the leadership of an Associate Commissioner known as the ACRA. This office is responsible for the activities and operations of the field headquarters staff and the field staff of FDA. The Regional Food and Drug Directors (RFDD's) report to this office.

This office advises and assists the Commissioner and other key officials on regulations and compliance oriented matters which have an impact on policy development and execution and long-range program goals.

As of August 2003 , there were about 626 employees in ORA headquarters and about 3508 additional employees in the ORA field organization.  For ORA contact information, see the ORA Field Contacts Directory at the end of this chapter .

Immediate office of ORA:

Special Assistant to ACRA - Alyson Saben

Special Assistant for Import Policy - Vacant

Regulatory Counsels - Carolyn Becker and Ann Kirchner

Performance Results Staff Coordinator - Marie Urban

Equal Employment Opportunity Staff - Mary Davis

Senior Advisor for Clinical Science - Lori Love

271 - ORA HEADQUARTERS ORGANIZATION

ORA consists of four individual offices which operate independently of each other. However, their functions are related and they support each other. A description of the function of each office is outlined below.

271.01 - Office of Resource Management (ORM) (HFC-10), James M. Strachan, Director

ORM is basically responsible for the planning, management, and evaluation of the operations of the field offices. It is also responsible for the computer systems which handle the information generated by the field offices.

The Division of Management Operations in ORM controls the budget for the field's day to day operations. ORM allocates funds as determined by actual needs of the field and headquarters units.

The training of personnel stationed in the field is also coordinated by The Division of Human Resource Development in ORM. The Deputy Director of ORM is vacant.

ORM has the following divisions:

1. Division of Management Operations (HFC-20)
   Director - Richard Garwood ; Deputy Director - Vacant
   1. Management Operations & Analysis Group
      Director - Vacant
   2. Financial & Program Analysis Group,
      Lee Swerock, Director
   3. Facilities Management Group,
      Randy Higgins, Director
2. Office of Information Technology (HFC-30)
   Mark Gregory, Director
   Donald Chi, Associate Director
   1. Paul Banas, Director, Infrastructure Management and Operations Branch
   2. Carole Stone, Director, Infrastructure Applications Branch
   3. Marvin Bell, Director, Enterprise Systems Branch
   4. Laurie Hager, Director, Customer Support Branch
   5. David Graves, ORA IT Enterprise Architect
      
3. Division of Planning, Evaluation and
   Management (HFC-40), Susan C. Baer, Director
   Vacant, Deputy Director
   1. Program Planning & Workforce Mgmt. Branch,
      Michael W. Roosevelt, Director
   2. Program Evaluation Branch
      John A. Lechus, Director
4. Division of Human Resource Development (HFC-60), Gary German, Director
   Leona O'Reilly, Deputy Director
5. Division of Personnel Operations
   Vacant, Director
6. Commissioned Corps Liaison, Virginia Mahady

Also included within ORM is the FDA History Office (HFC-24): John Swann, Suzanne White Junod, Ronald Ottes, and Robert Tucker .

271.02 - Office of Regional Operations (ORO) (HFC-100) Deborah D. Ralston, Director

The Director of ORO is currently Deborah D. Ralston. The Deputy Director is Steven Solomon, Ph.D. Special Assistant to the Director is Kara Lynch.

ORO coordinates and manages all Agency field operations and the Team Biologics Core Team on behalf of the ACRA; 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.

It evaluates the overall management and capabilities of the Agency's field organization; initiates action to improve the management of field activities. Coordinates nationwide health fraud activities between the field, states, and Headquarters organizations. Coordinates field public affairs and information programs; distributes timely information to the field; coordinates activities with Agency counterpart organizations. Serves as the Agency focal point in developing and maintaining international regulatory policy and activities to assure the safety, efficacy, and wholesomeness of regulated imported products. Coordinates Agency procedures with Headquarters and field offices and is the primary contact with the U.S. Customs Service and others among those offices. Develops and/or recommends to the ACRA policy, program, and plans for applied research relating to Agency enforcement problems; coordinates such research efforts with appropriate agency components. Directs and coordinates the Agency's emergency preparedness and civil defense programs. Provides other Agency components with laboratory support in highly specialized areas.

ORO has the following components:

1. Emergency Operations Center (HFC-160)
   Ellen Morrison, Director
   Conception Cruz , Deputy Director
   The Emergency Operations Center, was recently reorganized into the new Office of Crisis Management under the Office of the Commissioner. Future IOM updates will reflect this change. It coordinates and provides facts regarding epidemiological investigations and other potential imminent dangers to public health on a 24-hour, seven-day-a-week basis to Headquarters, regional and district staff.
   The Division Director and Deputy Director may be reached at (301) 827-5653, the 24 hour emergency line (301)443-1240 or on their direct lines (301) 827-5660 (Ellen Morrison) and (301)827-5655 (Dep. Director).
   Personnel assigned to the Emergency Operations Center:

   Pete Cook	Emergency Coordinator	(301) 827-5630
   Lara Davidson	Bioterrorism Coordinator	(301) 827-2170
   Mark I. Fow, Ph.D.	Emergency Coordinator	(301) 827-5650
   Sandra Hanson	Emergency Coordinator	(301) 827-5642
   Vacant	Epidemiologist	(301) 827-2180
   Israel Santiago	National Consumer Complaint and Emergency Operations Coordinator	(301) 827-5670

2. Division of Field Investigations (HFC-130)
   Michael C. Rogers, Director (301) 827-5653
   DFI provides coordination, direction, assistance, and management for the field's domestic and foreign investigative activities. It serves as the Agency focal point for Headquarters/field relationships on investigational and inspection problems, and programs and operations.
   It develops and reviews investigative and inspectional procedures, training programs, and prepares and issues investigative and inspectional guidance manuals. The division provides the field investigative and engineering technical assistance and guidance for foreign inspections.
   DFI has two branches: Domestic Operations Branch and International Operations Branch. The Division's deputy director manages ORA's National Experts.
   Patricia Alcock Lefler is the Deputy Director. She can be reached at (301) 827-5653.
   Gerald Miller is the Director of the Domestic Operations Branch. He can be reached at (301) 827-5653.
   Rebecca Ramos Hackett is the Manager of the International Operations Branch. She may be reached at (301) 827-5653.
   The following personnel within the Domestic Operations Branch are available to help you in various program related activities and may be reached at DFI's main number (301) 827-5653 or at the number below:

   Charles Ahn	Computers/Computer Utilization, Human Drugs	(301) 827-5637
   James Dunnie	Human Drugs, Veterinary Drugs	(301) 827-5652
   Norman Fogg	Foods	(301) 827-5645
   Alan Gion	Medical Devices	(301) 827-5649
   Gail Katz	Biologics	(301) 827-3357
   Ruark Lanham	Foods	(301) 827-6691
   Barbara Marcelletti	Foods, Seafood HACCP	(301) 827-5635
   Diann Shaffer	Bioresearch Monitoring	(301) 827-1124
   Christine Twohy	Biologics, Microbiology	(301) 827-5662
   Valerie Wright	Medical Devices	(301) 827-5646

   
   Personnel responsible for foreign inspections and trip planning in the International Operations Branch:

   Linda Adams	Tech. Asst. Int'l Inspections	(301) 827-5648
   Thanh Andrews	Devices Int’l Inspections	(301) 827-2975
   Doreen Chin	Quee Tech Asst. Int'l Inspections	(301) 827-5632
   Pattie Everett	Tech Asst. Int'l Inspections	(301) 827-5629
   Cherae Frazier	Tech Asst. Int'l Inspections	(301) 827-5628
   Atilla Kadar	BIMO Int'l Inspections	(301) 827-5647
   vacant	Drug Int'l Inspections	(301) 827-2975
   Irma Rivera	Tech Asst. Intl. Inspections	(301) 827-5665
   Janet Rowe	Tech. Asst. Int'l Inspections	(301) 827-5633
   Patricia Simmons	Tech. Asst. Int'l Inspections	(301) 827-5668
   vacant	Drug Int'l Inspections	(301) 827-5653
   Joyce Watson	Biologics Int'l Inspections	(301) 827-5636

   
   
   The National Experts assigned to DFI are:

   Thomas Arista	DAL-DO Biotechnology NE	(214) 655-5308
   Mary T. Carden,	NYK/BUF Biologics NE	(716) 551-4461
   Karen A. Coleman	ATL-DO Devices NE	(404) 347-3218
   Robert Coleman	ATL-DO Drugs/Bimo NE	(404) 347-3218
   Debra Devlieger	SEA-DO Food/LACF NE	(206) 553-7001
   Charles M. Edwards	PHI-DO Drugs/Bimo NE	(215) 597-0983
   Mike Ellison	BLT-DO Food/LACF NE	(410) 749-0540
   Brian Hendrickson	DET-DO Food/LACF NE	(317) 226-6500x12
   Joan Loreng	PHI-DO Biologics NE	(215) 362-0740
   Rebeca Rodriguez	SJN-DO Drug NE	(787) 474-9556
   Robert D. Tollefsen	SEA-DO Computer NE	(425) 486-8788
   David B. Wieneke	MIN-DO Food, Aseptic Processing, Dairy NE	(612)334-4100
   Norman Wong	SEA-DO Devices NE	(206) 483-4935

3. Division of Field Science (DFS) HFC-140
   Michael Olson, Director
   Thomas Savage, Deputy Director
   (301) 827-1232
   DFS provides a focal point for all aspects of ORA Field Laboratories and serves as the Headquarters' scientific and technical staff. It manages FDA's overall field scientific resources to assure their coordinated, efficient, and effective use; provides coordination between field and center scientific programs, and develops and manages the Science Advisor Program and Department of Defense Shelflife Extension Program.
   DFS manages field research programs and the applicability of new, complex, scientific instruments for field analyses and provides scientific and analytical expertise related to laboratory automation, analysis, process control and acquisition of automated data laboratory instruments. DFS manages the scientific aspects of the FACTS. The Division participates in the determination of long and short-range field scientific facility needs and in the formulation, delivery, and evaluation of training and career development plans for field scientists. Program contacts in DFS are:
   
   1. Carl Sciacchitano, Research Planning &
      Coordination Team Leader (301) 827-7606
   2. Larry D'Hoostelaere, CBER/CDRH programs contact
   3. Marsha Hayden, CFSAN programs contact
   4. Elise Murphy, CDER programs contact
   5. George Salem, CVM programs contact
4. Division of Federal-State Relations (DFSR)
   HFC-150 - Richard Barnes, Director
   (301)443-3360
   Paul Raynes, Deputy Director
   DFSR is the ORA headquarters focal point for interactions with the regional specialists located in every region, that comprise the Federal-State Cooperative Programs (SCP). The SCP are composed of three separate food safety programs, the Interstate Milk Shippers Program, the National Shellfish Sanitation Program and the Retail Food Protection Program. The authority for these programs is provided in the Public Health Service Act (42 USC 243).
   FDA has signed Memoranda of Understanding (MOU's) with the Interstate Milk Shippers Conference and the Interstate Shellfish Sanitation Conference. These MOU's spell out FDA and state responsibilities that must be met to insure the uninterrupted shipment of these commodities between states. FDA has also signed an MOU with the Conference of Food Protection that will guide future federal-state cooperation in this program. See IOM Chapter 3 for an explanation of all MOU's.
   Funding and position allocation for the Cooperative Programs is through the Center for Food Safety and Applied Nutrition (CFSAN) which makes allocations to ORA for the programs.
   Regional Specialists are the first point of contact for the states for answers and explanations on any technical issues that arise. Several Cooperative Program Specialists are located in each Region and are available to answer questions and offer assistance and expertise when investigations involve these products.
   • RETAIL FOOD PROTECTION PROGRAM (Retail Food Safety Program)
     The primary objective of the Retail Food Safety Program is to prevent foodborne illness at the retail level of the food industry by directing activities toward promotion of effective state and regulatory programs. Regional Food Specialists (RFS) are responsible for state program evaluations, standardization of state officials, training and technical assistance to state programs. Interstate Travel Sanitation Program (ITP) Specialists, located in the Districts, receive training and standardization from the RFS. Regional Food Specialists may be asked for technical assistance on a variety of food safety and public health topics.
   • INTERSTATE MILK SHIPPERS PROGRAM (Milk Safety Program)
     The objectives of the Milk Safety Program activities are to provide assistance to the states in the prevention of food-borne and communicable diseases and in the adoption, implementation and enforcement of the uniform technical guidelines, administrative procedures and regulatory standards provided in the Pasteurized Milk Ordinance (PMO) and related documents. Regional Milk Specialists (RMS) provide technical assistance and training, conduct check-ratings (audits) and standardize state officials. The RMS's also evaluate state programs to measure state program effectiveness, provide advice on the program's strengths and weaknesses and make recommendations for improvements.
   • NATIONAL SHELLFISH SANITATION PROGRAM (Shellfish Safety Program)
     The objective of the Shellfish Safety Program is to prevent food-borne illness from the consumption of raw Molluscan shellfish, primarily oysters, clams and mussels. Food borne illnesses from these organisms include a variety of hazardous materials such as heavy metals, biological toxins, and pathogens. FDA provides oversight to 29 states and four foreign countries that are members in the National Shellfish Sanitation Program (NSSP). The NSSP provides for a system of controls, which follow the shellfish from their growing area through harvest, distribution and wholesale sale. FDA Regional Shellfish Specialists (RSS) evaluate state and foreign programs, and provide training and technical assistance regarding the current practice in shellfish control and related topics of environmental science and shellfish processing.
5. Division of Import Operations Policy
   (DIOP) HFC-170
   Director Carl Nielsen
   Deputy Director, Joseph L. McCallion
   This division provides direction, assistance, management and oversight of field import operations. Serves as Agency focal point for contact with U.S. Customs and other Federal Agencies regarding import activities. Develops and reviews agency import policies, procedures, programs, etc. and is responsible for issuing import informational directives (Import Alerts, Bulletins, etc.) and RPM, Chapter 9. DIOP is responsible for the maintenance of the Operational and Administrative System for Import Support (OASIS), including the coordination with program Centers to establish automated screening criteria.
   Contact points within DIOP are:
   1. Systems Branch (HFC-171)
      Vacant, Director
   2. Operations and Policy Staff (HFC-172)
      Rotational Coordinator
   3. Customs Liaison (HFC-170)
      Vacant

271.03 - Office of Enforcement (OE) - HFC-200 David K. Elder, Director

The Director of OE is David K. Elder and the Director of Compliance is Carl E. Draper.

OE advises and assists the ACRA and other key officials on regulations and compliance policy matters which impact on policy development, implementation and long range goals. OE also coordinates, interprets, and evaluates the FDA's overall compliance efforts and, as necessary, establishes compliance policy and recommends policy to the ACRA.

OE also acts as liaison with other federal agencies on compliance matters, evaluates proposed legal actions, coordinates actions with the Office of Regional Operations (ORO) and the Office of Chief Counsel (OCC) and handles appeals of proposed compliance actions which are disapproved by the centers or OCC.

This office coordinates agency bioresearch monitoring activities and serves as Agency focal point for the Federal Medical Products Quality Assurance Program (GWQAP).

OE consists of the following elements:

1. Division of Compliance Management and
   Operations & Recall Staff (HFC-210)
   Sandra Whetstone, Director
2. Division of Compliance Policy (HFC-230)
   Lana Ogram, Director
3. Division of Compliance Information & Quality
   Assurance Staff (HFC-240)
   Scott MacIntire, Director
   

271.04 - Office of Criminal Investigations (OCI) (HFC-300) Terrell L. Vermillion, Director

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 170 employees in headquarters and the field.

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

• Northeast New York, NY
• Central Philadelphia, PA
• Southeast Atlanta, GA
• Southwest Dallas, TX
• Pacific San Francisco, CA

Each regional office controls 2 to 7 district offices.

There are currently 20 district offices located in major cities around the country. IOM Appendix G shows the location of these district offices. The regional affiliation of these offices is also indicated in the Appendix.

Each district office (DO) is usually comprised of four branches or units as follows:

1. Administrative Branch
2. Compliance Branch
3. Investigations Branch - some DO's may have 2 investigations sections, one for domestic products and one for imported products.
4. Laboratory Branch - not all DO's have laboratories

Some districts have combined branches and some have gone to team based structures which are different from the traditional branch structure.