SUBCHAPTER 1.9 - OFFICE OF REGULATORY AFFAIRS

1.9 - OFFICE OF REGULATORY AFFAIRS
1.9.1 - Associate Commissioner for Regulatory Affairs
1.9.2 - ORA HEADQUARTERS ORGANIZATION
      1.9.2.1 - Office of Resource Management (ORM) (HFC-10), James M. Strachan, Director
      1.9.2.2 - Office of Regional Operations (ORO) (HFC-100) Deborah D. Ralston, Director
         1.9.2.2.1 - Division of Field Investigations (DFI) (HFC-130)
         1.9.2.2.2 - Division of Field Science (DFS) (HFC-140)
         1.9.2.2.3 - Division of Federal-State Relations (DFSR) (HFC-150)
         1.9.2.2.4 - Division of Import Operations Policy (DIOP) (HFC-170)
            1.9.2.2.4.1 - Prior Notice Center (PNC) (HFC-180)
      1.9.2.3 - Office of Enforcement (OE) (HFC-200) David K. Elder, Director
      1.9.2.4 - Office of Criminal Investigations (OCI) (HFC-300) Terrell L. Vermillion, Director
1.9.3 - ORA FIELD ORGANIZATION

 1.9 - OFFICE OF REGULATORY AFFAIRS 

 1.9.1 -ASSOCIATE COMMISSIONER FOR REGULATORY AFFAIRS

The Acting Associate Commissioner for Regulatory Affairs (ACRA) is Michael A. Chappell, and the Deputy Associate Commissioner for Compliance Policy is Steven M. Solomon, DVM, MPH. The Deputy Associate Commissioner for Field Operations is Michael A. Chappell

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 Headquarters Office Directors and 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 November 2008, there were over 3500 employees in the ORA field organization including ORA headquarters. For ORA contact information, see the ORA Field Contacts Directory at the end of this manual.

Immediate office of ORA:

Special Assistant to ACRA - Amy Waltrip
Regulatory Counsels - Carolyn Becker and Anne Kirchner

Senior Advisor for Risk Analysis – Kara Morgan
QMS – Brenda Holman

Senior Advisor for Science – John Marzilli
ORA Executive Operations - Charlotte Christin

 1.9.2 - 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.

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

The Deputy Director of ORM is Michael W. Roosevelt.

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.

1. The training of personnel stationed in the field is also coordinated by The Division of Human Resource Development in ORM. ORM has the following divisions:
2. Division of Management Operations (HFC-20)
   Director - Richard Garwood
   1. Management Operations and Analysis Group
      Michele M. Berger, Supervisor
   2. Financial and Program Analysis Group,
      Andrea Oliver, Director
   3. Facilities Management Group,
      Randy Higgins, Supervisor
3. Division of Planning, Evaluation and Management (HFC-40),
   John A. Lechus, Director
   1. Program Planning and Workforce Mgmt. Branch,
      Carrie Mampilly, Supervisor
   2. Program Evaluation Branch
      Lynnette I. Riggio, Supervisor
4. Division of Human Resource Development (HFC-60),
   Gary German, Director
   Vacant, Deputy Director
5. Commissioned Corps Liaison, Diann Shaffer
6. FDA History Office (HFC-24): John Swann, and Suzanne White Junod, Historians.

 1.9.2.2 - Office of Regional Operations (ORO) (HFC-100) David K. Elder, Director

The Director of ORO is David K. Elder. The Deputy Director is vacant. Special Assistant to the Director is Kara Lynch. International Affairs Program Manager is vacant.

ORO coordinates and manages all Agency field operations, Team Biologics Core Team, and the Prior Notice Center 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:

 1.9.2.2.1 - DIVISION OF FIELD INVESTIGATIONS  (HFC-130)

Michael C. Rogers, Director 301-827-5653
Patricia Alcock, Deputy 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.

Gerald D. Bromley, Jr. is the Director of the Domestic Operations Branch, and Rebecca Ramos Hackett is the Director of the International Operations Branch. They 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 numbers below:

James Dunnie	Human Drugs, Veterinary Drugs	301-827-5652
Norman Fogg	Foods	301-827-5645
Vacant	Medical Devices
Gail Katz	Biologics	301-827-3357
Ruark Lanham	Bioresearch Monitoring, Good Laboratory Practices (GLPs)	301-827-6691
Barbara Marcelletti	Foods, Seafood HACCP	301-827-5635
Vacant	Bioresearch Monitoring, Clinical
Vacant	Biologics, Microbiology

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

Linda Adams	Drugs	301-827-5648
Olaide Akimade	Drugs	301-827-3902
Oumou Barry	Biologics	301-827-3904
Deborah Blanks	Foods	301-827-0943
Barbara Blosser	Drugs	913-752-2466
Dyrene Braswell	Program Assistant	301-827-5659
Luis A. Carrion	Foods	787-474-9520
Lawrence Carter	Drugs	301-827-3903
Doreen Chin Quee	Devices	301-827-5632
Denaja Crutchfield	Assistant	301-827-6884
Olga Duran	Drugs	301-827-5644
Patricia Griffin	Devices	301-827-5668
Attila Kadar	Bimo	301-827-5647
Tania Mercado	Bimo	301-827-5637
Heriberto Negron-Rivera	Drugs	301-827-3901
Irma Rivera	Drugs	301-827-5665
Minerva Rogers	Devices	301-827-5633
Naveen Walker	Foods	301-827-0167
Joyce Watson	Biologics	301-827-5664
Marisa White	Bimo	301-827-5629

The National Experts, stationed at a District office or resident post, are assigned to DFI.

Thomas Arista	DAL-DO Biotechnology	214-253-4920
Regina T.  Brown	NWJ-DO Drugs	732-940-8946 x14
Mary T. Carden,	NYK/BUF Biologics	716-541-0352
Debra Devlieger	SEA-DO Food/LACF	206-842-0251
Sharon K. Thoma	MIN-DO Drugs	612-758-7159
Brian Hendrickson	DET-DO Food/LACF	317-226-6500 x104
Joan Loreng	PHI-DO Biologics	215-717-3724
Dr. Gerald McGirl	SAN-DO BIMO	510-337-6850
Rebeca Rodriguez	SJN-DO Drugs	787-474-9556
Robert D. Tollefsen	SEA-DO Computer	425-483-4923
David B. Wieneke	MIN-DO Food, Aseptic Processing, Dairy	612-758-7177
Kimberly Lewandowski-Walker	MIN-DO Devices	414-771-7167 x23
Norman Wong	SEA-DO Devices	206-483-4935
Ingrid Zambrana	ATL-DO Food Outbreak and Food Defense	404-253-1284

 1.9.2.2.2 - DIVISION OF FIELD SCIENCE (DFS)      (HFC-140)

Carl Sciacchitano, 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 Shelf life 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. Larry D' Hoostelaere, CBER/CDRH programs contact; Mad Cow and TSE issues
2. Marsha Hayden, CFSAN programs contact
3. Don Lech, CDER programs contact
4. George Salem, CVM programs contact

They can all be reached at 301-827-7605/6

 1.9.2.2.3 - DIVISION OF FEDERAL-STATE RELATIONS (DFSR) (HFC-150)

Richard H. Barnes, Director 301-827-6906

Preetham R. Sudhaker, Staff Manager, Contracts and Grants Staff

Catherine M. McDermott, Staff Manager, Public Affairs and Information Staff

DFSR interacts with counterpart State and local officials to promote cohesive and uniform policies and activities in food and drug related matters. It also serves at the focal point for cooperating officials from state agencies that need information, coordination or services from headquarter units. DFSR coordinates efforts between FDA and state and local counterparts. DFSR also provides information to and receives information from state, territorial, and local agencies. Work is completed by cooperating directly with state and local government officials and industry and indirectly through FDA field offices and national regional and state associations.

DFSR manages a contract/grant program with the states benefiting them with technical training, familiarity with federal requirements and more uniform enforcement of consumer laws through cooperation and coordination with FDA. Contracts involve food safety, tissue residues, radiological health, and medicated feeds which allows FDA to enlarge coverage of the Official Establishment Inventory (OEI) and also to redirect resources to other problems. Grants include areas in Food Safety and Food Defense, Health Fraud and small conference issues. Cooperative agreements include areas in FERN and BSE.

DFSR coordinates work between FDA and State and local agencies through Voluntary Work Agreements such as partnership agreements, memoranda of understanding (MOU's) and coordinated operations plan for emergencies (COPE).

DFSR serves as Liaison for Cooperative Programs between headquarters, CFSAN and FDA field staff. Cooperative Programs include the retail food program, milk safety and shellfish sanitation program areas which CFSAN leads the daily responsibility for providing assistance to FDA regional specialists who in turn interact with state specialists. DFSR also provides policy and technical information on medicated feeds and drugs to state control officials. 

DFSR is responsible for the commissioning of State officials and oversees the national program which provides authority to state and local officials to conduct investigations and collect samples to enforce the Federal Food Drug and Cosmetic Act. Also included is the sharing of a wide range of Agency documents as well as responding to state and local requests for information on Agency policy or position. DFSR coordinates the activities of FDA Field Public Affairs Specialists (PAS), the first line contact for consumers, health professionals, academia and the media on current and emerging FDA issues. DFSR is responsible for monitoring and maintaining the Public Affairs Reporting System (PAIRS). DFSR is responsible for the State Advisory Fax/Email System (SAFES), a communication system, which allows FDA to send out information including fax and e-mail emergency/priority messages to specific program groups, e.g. State Boards of Pharmacy, State Health Commissioners, State Food Program Directors, and others 24 hours/day.

 1.9.2.2.4 - DIVISION OF IMPORT OPERATIONS POLICY (DIOP) (HFC-170)

Domenic J. Veneziano, Director 301-443-6553

Deputy Director, Vacant

This division provides direction, assistance, management and oversight of field import operations. It 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)
   Steven Kendall, Director 301-594-1162
2. Operations and Policy Branch (HFC-172)
   John E. Verbeten, Director 301-594-3845

 1.9.2.2.4.1 - Prior Notice Center (PNC) (HFC-180)

Laura J. Draski, Director 301-621-7809

Anthony C. Taube, Deputy Director 866-521-2297

The PNC was established as a result of the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (BTA), specifically related to the prior notice requirements of the BTA. The PNC provides a focal point to the FDA field on all aspects of Prior Notice with expertise in researching import shipments and their related firms. The PNC operates 24 hours a day, 7 days a week within Customs & Border Protection’s National Targeting Center to receive, review and provide the appropriate response to information submitted in advance of FDA regulated food products, including animal feed, imported or offered for import into the United States.  The purpose of prior notice is to enable FDA to target for exam the highest risk imported foods at the time of arrival, in order to maximize food safety and security in the United States and to prevent products that may be intentionally contaminated and/or may pose a potential significant health risk due to terrorism or other health related emergency from entering into U.S. Commerce.

Contact Points within Prior Notice Center are:

Nabil Anis, Watch Commander
D. Yvette Arline, Watch Commander
Greta Budweg, Watch Commander
Kelli Giannattasio, Watch Commander
Janice Gordon, Watch Commander
Jamie Hughes, Watch Commander
Lonna Potter, Watch Commander
Angel Suarez, Watch Commander
Marilyn White, Watch Commander 

All of the above can be reached at 866-521-2297

 1.9.2.3 - Office of Enforcement (OE)(HFC-200) Vacant, Director

The Director of OE is vacant and the Deputy Director is Alyson L. Saben.

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 (DCMO) and Recall Staff (HFC-210) Vacant, Director
2. Division of Compliance Policy (DCP)(HFC-230) Douglas W. Stearn, Director
3. Division of Compliance Information and Quality Assurance (DCIQA) Staff (HFC-240) Katherine A. Hollinger, Director

 1.9.2.4 - 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.

 1.9.3 - ORA FIELD ORGANIZATION

The ORA field organization is divided into regional offices. The Regional Offices are under the control of Regional Food and Drug Directors (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 directs 2 to 7 district offices.

There are currently 20 district offices located in major cities around the country. Each district office (DO) is usually comprised of four branches or units as follows:

1. Administrative Branch
2. Compliance Branch
3. Investigations Branch - some DOs may have 2 investigations sections, one for domestic products and one for imported products.

Laboratory Branch - not all DOs have laboratories