U.S. Departments and Offices

December 1, 2007
Jill Wechsler

Jill Wechsler is ACT's Washington Editor

Applied Clinical Trials

Applied Clinical Trials, Applied Clinical Trials-12-01-2007, Volume 0, Issue 0

A comprehensive listing of U.S. departments and offices that includes the telephone numbers of directors, commissioners, and advisors.

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Office for Human Research Protection

Director

Ivor Pritchard* (240) 453-6900

NIH Institutes, Center, and Divisions

Deputy Director and Director, Office of International Activities

Melody Lin (240) 453-8126

Associate Director, Regulatory Affairs

Michael Carome (240) 453-8237

Director, Division of Compliance Oversight

Kristina Borror (240) 453-8132

Director, Division of Education and Development

Shirley Hicks (240) 453-8227

Director,Division of Policy and Assurances

Irene Stith-Coleman (240) 453-8138

FOOD AND DRUG ADMINISTRATION

Office of the FDA Commissioner

Commissioner

Andrew von Eschenbach (301) 827-3310

Chief of Staff

Susan Winckler (301) 827-3310

Deputy Commissioner for Operations and Chief Operating Officer

John Dyer (301) 827-3310

Deputy Commissioner and Chief Medical Officer

Janet Woodcock (301) 827-3310

Deputy Commissioner for Policy, Planning, and Preparedness

Randall Lutter (301) 827-3370

Deputy Commissioner for International and Special Programs

Murray Lumpkin (301) 827-5709

Chief Counsel

Gerald Masoudi (301) 827-1137

Assistant Commissioner for External Relations

Theresa Toigo* (301) 827-6251

Department of Health and Human Services: Food and Drug Administration

Assistant Commissioner for Planning

Malcolm Bertoni* (301) 827-5292

Assistant Commissioner for Policy

Jeffrey Shuren (301) 827-3360

Assistant Commissioner for Counterterrorism and Emerging Threats

Boris Lushniak (301) 827-4067

Assistant Commisioner for Integrity and Accountability

William McConagha (301) 827-4067

Assistant Commissioner for International Programs

Melinda Plaisier (301) 827-4480

Director, Office of Pediatric Therapeutics

Dianne Murphy (301) 827-1996

Director, Office of Combination Products

Joanne Less* (301) 427-1934

Associate Commissioner for Management

Kathleen Heuer (301) 255-6762

Director, Office of Crisis Management

Ellen Morrison (301) 827-5660

Director, Office of Critical Path Programs

Rachel Behrman (301) 827-5660

Director, National Center for Toxicological Research

William Slikker (301) 827-5660

Associate Commissioner for Science and Health Coordination

Norris Alderson (301) 827-3340

Assistant Commissioner for Women's Health

Kathleen Uhl (301) 827-0350

Director, Office of Orphan Products Development

Timothy Cote (301) 827-3666

Director, Office of Special Health Issues

Theresa Toigo (301) 827-4460

GoodClinicalPracticeProgram

Special Assistant to the Director

Patricia Beers Block (301) 827-3340

Expert Consumer Safety Officer

Carolyn Hommel (301) 827-3340

Senior Advisor for Clinical Science

David Lepay (301) 827-3340

Biophysicist

Jean Toth-Allen (301) 827-3340

Office of Regulatory Affairs

Associate Commissioner for Regulatory Affairs

Margaret Glavin (301) 827-3101

Deputy Commissioner for Compliance Policy

David Horowitz (301) 827-3101

Deputy Commissioner for Field Operations

Diana Kolaitis (718) 662-5416

Senior Advisor for Clinical Science

Lori Love (301) 827-3684

Center for Devices and Radiological Health

Director

Daniel Schultz (240) 276-3939

Deputy Director

Linda Kahan (240) 276-3939

Director, Office of Device Evaluation

Donna Bea Tillman (240) 276-3993

Director, Office of Compliance

Timothy Ulatowski (301) 276-0100

Director, Division of Bioresearch Monitoring

Michael Marcarelli (301) 276-0125

Director, Office of In Vitro Diagnostic Device Evaluation and Safety

Steven Gutman (240) 276-0375

Director, Office of Surveillance and Biometrics

Susan Gardner (240) 276-0125

Center for Drug Evaluation and Research (CDER)

Director

Janet Woodcock* (301) 594-5400

Deputy Director

Douglas Throckmorton (301) 594-5400

Associate Director for Safety Policy and Communications

Paul Seligman (301) 594-0104

Associate Director for Medical Informatics

Randy Levin (301) 827-7784

Associate Director for Analysis and Strategic Initiatives

Theresa Mullin (301) 594-5400

Associate Director for International Programs

Justina Molzon (301) 594-5400

Associate Director for Regulatory Policy

Jane Axelrad (301) 594-5400

Director, Office of Executive Programs

Deborah Henderson (301) 594-6779

Director, Office of Management

Russell Abbott (301) 594-6741

Director, Office of Training and Communication

Nancy Smith (301) 827-1651

Director, Office of Information Technology

James Shugars (301) 827-6240

Director, Office of Counterterrorism and Emergency Coordination

Rosemary Roberts (301) 796-2210

Office of Translational Services

Director

ShaAvhree Buckman (301) 796-2600

Director, Office of Clinical Pharmacology and Biopharmaceutics

Lawrence Lesko (301) 796-2450

Director, Office of Biostatistics

Robert O'Neill (301) 796-1700

Office of Compliance

Director

Deborah Autor (301) 827-8910

Deputy Director

Joe Famulare (301) 827-8910

Director, Division of Scientific Investigations

Gary Della'Zanna (240) 276-8817

Deputy Director

Joseph Salewski (240) 276-8817

Chief, Good Clinical Practices Branch I

Constance Lewin (240) 276-8829

Chief, Good Clinical Practices Branch II

Leslie Ball (240) 276-8840

Chief, GLP/Bioequivalence Investigations Branch

C.T. Viswanathan (240) 276-8853

Office of Medical Policy

Director

Robert Temple (301) 796-2270

Deputy Director

Rachel Behrman* (301) 796-2270

Director, Division of Drug Marketing, Advertising, and Communications

Thomas Abrams (301) 796-1200

Office of New Drugs

Director

John Jenkins (301) 796-0700

Deputy Director

Sandra Kweder (301) 796-0700

Director, Office of Drug Evaluation I

Robert Temple* (301) 796-2270

Director, Office of Drug Evaluation II

Curtis Rosebraugh* (301) 796-2310

Director, Office of Drug Evaluation III

Julie Beitz (301) 796-2100

Director, Office of Antimicrobial Products

Edward M. Cox (301) 796-1300

Director, Office of Oncology Products

Richard Pazdur (301) 796-2340

Director, Office of Nonprescription Products

Charles Ganley (301) 796-2060

Office of Pharmaceutical Science

Director

Helen Winkle (301) 796-2400

Deputy Director

Keith Webber (301) 796-2400

Director, Office of New Drug Quality Assessment

Moheb Nasr (301) 796-1900

Director, Office of Generic Drugs

Gary Buehler (240) 276-9310

Director, Office of Testing and Research

Vincent Vilker (301) 796-0200

Director, Office of Biotechnology Products

Steven Kozlowski (301) 796-2390

Office of Surveillance and Epidemiology

Director

Gerald Dal Pan (301) 796-2380

Center for Biologics Evaluation and Research (CBER)

Director

Jesse Goodman (301) 827-0372

Deputy Director

Karen Midthun (301) 827-0376

Associate Director for Research

Kathryn Carbone (301) 827-0377

Associate Director for Policy

Diane Maloney (301) 827-0372

Associate Director for Quality Assurance

Sheryl Lard-Whiteford (301) 827-0379

Associate Director for Review Management

Robert Yetter (301) 827-0373

Senior Advisor for International Affairs

Joan W. Blair (301) 827-0639

Senior Policy Advisor for Chemistry and Manufacturing Controls

Christopher Joneckis (301) 435-5681

Director, Office of Biostatistics and Epidemiology

Steven Anderson* (301) 827-3034

Director, Office of Communication, Training, and Manufacturers Assistance

Lorrie McNeill (301) 827-2000

Director, Office of Management

Joseph Biviano (301) 827-1320

Director, Office of Information Technology

Ginger Leo (301) 827-1368

Director, Office of Blood Research and Review

Jay Epstein (301) 827-3518

Director, Office of Vaccines Research and Review

Norman Baylor (301) 827-0655

Director, Office of Cellular, Tissue, and Gene Therapies

Celia Witten (301) 827-6536

Director, Office of Compliance and Biologics Quality

Mary Anne Malarkey (301) 827-6190

Director, Division of Inspections and Surveillance

Gilliam Conley (301) 827-6221

Chief, Bioresearch Monitoring Branch

Patricia Holobaugh (301) 827-6221

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