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Contents
SUBCHAPTER 270
- OFFICE OF REGULATORY AFFAIRS
270 - ASSOCIATE
COMMISSIONER FOR REGULATORY AFFAIRS (HFC-1)
271 - ORA HEADQUARTERS
ORGANIZATION
271.01 - Office of Resource Management (ORM) (HFC-10), James M. Strachan, Director
271.02
- Office of Regional Operations (ORO) (HFC-100) Deborah D. Ralston, Director
271.03
- Office of Enforcement (OE) - HFC-200 David K. Elder, Director
271.04
- Office of Criminal Investigations (OCI) (HFC-300) Terrell L. Vermillion, Director
272 - ORA FIELD
ORGANIZATION
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:
- Division of Management Operations (HFC-20)
Director - Richard Garwood
; Deputy Director - Vacant
- Management Operations & Analysis Group
Director - Vacant
- Financial & Program Analysis Group,
Lee Swerock, Director
- Facilities Management Group,
Randy Higgins, Director
-
Office of Information Technology (HFC-30)
Mark Gregory, Director
Donald Chi, Associate Director
- Paul Banas, Director, Infrastructure Management and Operations Branch
- Carole Stone, Director, Infrastructure Applications Branch
- Marvin Bell, Director, Enterprise Systems Branch
- Laurie Hager, Director, Customer Support Branch
- David Graves, ORA IT Enterprise Architect
- Division of Planning, Evaluation and
Management (HFC-40), Susan C. Baer, Director
Vacant, Deputy Director
-
Program Planning & Workforce Mgmt. Branch,
Michael W. Roosevelt,
Director
-
Program Evaluation Branch
John A. Lechus, Director
- Division of Human Resource Development (HFC-60), Gary German, Director
Leona O'Reilly, Deputy Director
- Division of Personnel Operations
Vacant,
Director
- 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:
- 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 |
- 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 |
- 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:
- Carl Sciacchitano, Research Planning &
Coordination Team Leader
(301) 827-7606
- Larry D'Hoostelaere, CBER/CDRH programs contact
- Marsha Hayden, CFSAN programs contact
- Elise Murphy, CDER programs contact
- George Salem, CVM programs contact
- 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.
- 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:
- Systems Branch (HFC-171)
Vacant, Director
- Operations and Policy Staff (HFC-172)
Rotational Coordinator
- 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:
- Division of Compliance Management and
Operations & Recall Staff (HFC-210)
Sandra Whetstone, Director
- Division of Compliance Policy (HFC-230)
Lana Ogram, Director
- 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:
- Administrative Branch
- Compliance Branch
- Investigations Branch - some DO's may have 2 investigations
sections, one for domestic products and one for imported products.
- 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.
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