Contents

SUBCHAPTER 210 - OFFICE OF THE COMMISSIONER

210 - IMMEDIATE OFFICE (OC)(HF-1) Pg 34

The Commissioner of the Food and Drug Administration is Mark B. McClellan, M.D., Ph.D.

The Deputy Commissioner of the Food and Drug Administration is Lester M. Crawford, D.V.M., Ph.D.

The immediate staff offices within the OC are:

1. Office of the Chief Council (GCF-1),
   Daniel Troy , Chief Counsel.
2. Administrative Law Judge (HF-3)
   Daniel J. Davidson, ALJ
3. Office of Equal Opportunity (HF-15)
   Anthony J. Kaminski, Acting Director
4. Senior Advisor for Science (HF-1)
   Bernard A. Schwetz, D.V.M., Ph.D.

The immediate OC has approximately 147 employees.

In addition, the four offices listed below will be discussed separately.

211 - OFFICE OF THE SENIOR ASSOCIATE COMMISSIONER (HF- 2)

The Office of the Senior Associate Commissioner is responsible for agency-level activities and decisions which affect agency-wide programs, projects, strategies and initiatives. Components under this office are:

1. Office of Executive Secretariat (HF-40)
   Catherine P. Beck, Director
2. Office of Public Affairs (HFI-1)
   Larry Bachorik , Interim Associate Commissioner
3. Office of the Ombudsman, Steve Unger,
   Acting Chief Mediator & Ombudsman
4. Office of Orphan Products Development (HF-35) Marlene E. Haffner, MD, Director
5. Office of Internal Affairs (HF-9)

Tommy L. Hampton, Special Agent in Charge

212 - OFFICE OF POLICY, PLANNING, AND LEGISLATION (HF-22)

The Associate Commissioner for Policy, Planning and Legislation is William K. Hubbard.

The Acting Associate Commissioner for Policy is Margaret Dotzel.

This office is responsible for developing, coordinating, managing, and researching the policy of the agency and includes the following staffs:

1. Office of Policy
   Regulations Policy and Management Staff,
   Edwin V. Dutra, Director
   Policy Development and Coordination Staff,
   Catherine Lorraine, Director
2. Office of Planning
   Planning Staff, Morris R. Bosin, Director
   Evaluation Staff, Kathleen A. McEvoy, Director
   Economics Staff, Lawrence Braslow, Director
3. Office of Legislation, Melinda Plaisier,
   Interim Associate Commissioner
   Michael A. Eck, Director
   Congressional Affairs Staff I,
   Congressional Affairs Staff II,
   Jarilyn Dupont, Director
   Congressional Affairs Staff III, Vacant, Director

The OPP&L has approximately 37 employees.

213 - OFFICE OF MANAGEMENT (HF-20)

This office is responsible for the planning and evaluation of agency activities and for the management of overall agency financial operations, human resources and management services, facilities, acquisitions and central services, plus information resources management.

The following offices are located in the Office of Management:

1. Office of Financial Management
   
2. Office of Chief Information Officer

   components:

   • Office of Business Enterprise Solutions
   • Office of Information Technology Shared Services
   
3. Office of Shared Services (OSS)
   OSS consists of the following components:
   • Immediate Office, OSS
   • Employee Resource & Information Center (ERIC)
   • Office of Equal Opportunity & Diversity Management
   • Office of Real Property Services
   • Office of Acquisitions & Grants Services
   
4. Office of Human Resources
   
5. Office of Management Programs
   
6. Office of Executive Operations

The Office of Management has approximately 616 employees

214 - OFFICE OF INTERNATIONAL AND CONSTITUENT RELATIONS (HF-24)

The Deputy Commissioner for the Office of International and Constituent Relations (OICR) is Sharon Smith Holston. This office is responsible for special health issues, women's health, consumer affairs, and international programs.

The following offices are located in OICR:

1. Office of International Programs (HFG-1)
   Sharon Smith Holston, Acting Director
2. Office of Consumer Affairs (HFE-1)
   Patricia M. Kuntze, Acting Associate Commissioner
3. Office of Women's Health
   Audrey Sheppard, Acting Director
4. Office of Special Health Issues (HF-12)
   Theresa Toigo, R.Ph., MBA, Associate
   Commissioner

The OICR has approximately 82 employees.