U.S. Departments and Offices

December 1, 2008
Jill Wechsler

Jill Wechsler is ACT's Washington Editor

Applied Clinical Trials

Applied Clinical Trials, Applied Clinical Trials-12-01-2008, 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

Jerry Menikoff (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

Elyse Summers* (240) 453-8236

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

Principal Deputy Commissioner and Chief Scientist

Frank Torti (301) 827-3310

Chief of Staff

Susan Winckler (301) 827-0087

Deputy Commissioner for Operations and Chief Operating Officer

John Dyer (301) 827-1166

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

Larry Bachorik* (301) 827-1352

Assistant Commissioner for Policy and Planning

Jeffrey Shuren (301) 827-3360

Assistant Commissioner for Planning

Malcolm Bertoni (301) 827-5292

Assistant Commissioner for Counterterrorism and Emerging Threats

Boris Lushniak (301) 827-4067

DEPARTMENT OF HEALTH AND HUMAN SERVICES FOOD AND DRUG ADMINISTRATION

Assistant Commisioner for Integrity and Accountability

William McConagha (301) 827-4427

Associate Commissioner for International Programs

Melinda Plaisier (301) 827-4480

Director, Office of Pediatric Therapeutics

Dianne Murphy (301) 827-1996

Director, Office of Combination Products

Thinh Nguyen (301) 427-1934

Associate Commissioner for Management

Kathleen Heuer (301) 255-6762

Associate Commissioner for Critical Path Programs

Rachel Behrman (301) 827-1512

Director, National Center for Toxicological Research

William Slikker (870) 543-7203

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

GoodClinicalPracticeProgram

Director

Joanne Less (301) 827-3340

Special Assistant to the Director

Patricia Beers Block (301) 827-3340

Senior Bioethicist

Sara Goldkind (301) 827-3340

Expert Consumer Safety Officer

Carolyn Hommel (301) 827-3340

Senior Advisor for Clinical Science

David Lepay (301) 827-3340

Policy Analyst

Marsha Melvin (301) 827-3340

Senior Health Policy Analyst

Kathleen Pfaender (301) 827-3340

Biophysicist

Jean Toth-Allen (301) 827-3340

Office of Regulatory Affairs

Associate Commissioner for Regulatory Affairs

Michael Chappell (301) 827-3107

Associate Deputy Commissioner for Compliance Policy

Steven Solomon (301) 827-3101

Center for Devices and Radiological Health

Director

Daniel Schultz (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) 276-3351

Center for Drug Evaluation and Research (CDER)

Director

Janet Woodcock (301) 796-5400

Deputy Director

Douglas Throckmorton (301) 796-5400

Associate Director for Medical Informatics

Randy Levin (301) 827-7784

Associate Director for Planning and Business Informatics

Theresa Mullin (301) 796-5400

Associate Director for International Programs

Justina Molzon (301) 796-5400

Associate Director for Safety Policy and Communications

Paul Seligman (301) 796-5401

Associate Director for Regulatory Policy

Jane Axelrad (301) 796-5400

Director, Office of Executive Programs

Deborah Henderson (301) 796-3200

Director, Office of Management

Russell Abbott (301) 796-3300

Director, Office of Training and Communication

Nancy Smith (301) 796-3700

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

Lawrence Lesko (301) 796-1656

Director, Office of Biostatistics

Robert O'Neill (301) 796-1700

Office of Compliance

Director

Deborah Autor (301) 796-3100

Deputy Director

Joe Famulare (301) 796-3100

Director, Division of Scientific Investigations

Leslie Ball (301) 796-3150

Deputy Director

Joseph Salewski (301) 796-3395

Chief, Good Clinical Practices Branch I

Constance Lewin (301) 796-3397

Chief, Good Clinical Practices Branch II

Tejashri Purohit-Sheth (301) 796-3402

Chief, GLP/Bioequivalence Branch

C.T. Viswanathan (301) 796-3394

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

Deputy Director

Henry "Skip" Francis (301) 796-2380

Director, Division of Risk Management

Claudia Karwoski* (301) 796-9832

Director, Division of Epidemiology

Solomon Iyasu (301) 796-2370

Director, Division of Medication Error Prevention and Analysis

Carol Holquist (301) 796-2360

Director, Division of Pharmacovigilance I

Mark Avigan (301) 796-2350

Director, Division of Pharmacovigilance II

Ann McMahon* (301) 796-2350

Center for Biologics Evaluation and Research (CBER)

Director

Jesse Goodman (301) 827-0372

Deputy Director

Karen Midthun (301) 827-0372

Associate Director for Research

Carolyn Wilson (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

Science Communications Advisor

Marc Kusinitz (301) 827-0372

Senior Advisor for International Affairs

Joan W. Blair (301) 827-0639

Senior Advisory for Counterterrorism/ Medical Countermeasures

Cynthia Kelley (301) 827-0636

Senior Advisor for Chemistry and Manufacturing Controls

Christopher Joneckis (301) 435-5681

Senior Regulatory Affairs Advisor

Lydia Falk (301) 827-9424

Director, Office of Biostatistics and Epidemiology

Robert Ball (301) 827-3034

Director, Office of Information Technology

Ginger Leo (301) 827-1368

Director, Office of Communication, Training, and Manufacturers Assistance

Lorrie McNeill (301) 827-2000

Director, Office of Management

James Sigg* (301) 827-1320

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) 827-6220

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