U.S. Departments and Offices

December 1, 2009
Jill Wechsler

Jill Wechsler is ACT's Washington Editor

Applied Clinical Trials

Applied Clinical Trials, Applied Clinical Trials-12-01-2009, 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

Senior Advisor to the Director

Ivor Pritchard (240) 453-8230

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

Margaret Hamburg (301) 827-3310

Principal Deputy Commissioner

Joshua Sharfstein (301) 827-3310

Deputy Commissioner for Science & Public Health & Chief Scientist

Jesse Goodman (301) 796-5040

Deputy Commissioner for International Programs

Murray Lumpkin (301) 827-5709

Chief Counsel

Michael Landa* (301) 827-1137

Assistant Commissioner for Policy

David Horowitz (301) 827-3360

Assistant Commissioner for Planning

Malcolm Bertoni (301) 827-5292

Assistant Commissioner for Counterterrorism & Emerging Threats

Boris Lushniak (301) 827-4067

Assistant Commissioner for External Relations

Larry Bachorik (301) 827-1352

Assistant Commissioner for Public Affairs

George Strait (301) 796-4540

Assistant Commissioner, Critical Path Programs

Rachel Behrman (301) 827-1512

Assistant Commissioner, International Programs

Mary Lou Valdez (301) 827-4480

Associate Commissioner for Science

Norris Alderson (301) 827-3340

Director, Office of Pediatric Therapeutics

Dianne Murphy (301) 827-1996

Director, Office of Combination Products

Thinh Nguyen (301) 427-1934

Director, Office of Special Health Issues

Theresa Toigo

Director, Office for Women's Health

Kathleen Uhl (301) 827-0350

Director, Office of Orphan Products Development

Timothy Cote (301) 827-3666

Director, Office of Bioresearch & Monitoring

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

Policy Analyst

Bridget Folz (301) 827-3340

Senior Health Policy Analyst

Kathleen Pfaender (301) 827-3340

Biophysicist

Jean Toth-Allen (301) 827-3340

Director, National Center for Toxicological Research

William Slikker (870) 543-7203

Director, Center for Tobacco Products

Lawrence Deyton

Office of Regulatory Affairs

Associate Commissioner for Regulatory Affairs

Michael Chappell* (301) 827-3101

Deputy Associate Commissioner for Compliance Policy

Steven Solomon (301) 827-3101

Center for Devices and Radiological Health

Director

Jeffrey Shurman* (240) 796-5900

Senior Associate Director

Lillian Gill (240) 796-5900

Director, Office of Device Evaluation

Donna Bea Tillman (301) 796-5550

Director, Office of Compliance

Timothy Ulatowski (301) 796-5504

Director, Division of Bioresearch Monitoring

Michael Marcarelli (301) 796-5629

Director, Office of In Vitro Diagnostic Device Evaluation and Safety

Alberto Gutierrez (301) 796-5453

Director, Office of Surveillance and Biometrics

Susan Gardner (240) 796-5996

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) 796-3422

Associate Director for International Programs

Justina Molzon (301) 796-5400

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

Julie Zawisza (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) 796-1565

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) 796-0895

Office of Pharmaceutical Science

Director

Helen Winkle (301) 796-2400

Deputy Director

Keith Webber (301) 796-2400

Director, Science & Resource Staff

Nakissa Sadrieh (301) 796-1598

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

Karen Midthun* (301) 827-0372

Deputy Director

Karen Midthun (301) 827-0372

Associate Director for Research

Carolyn Wilson (301) 827-0481

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

Director, Office of Biostatistics & Epidemiology

Robert Ball (301) 827-3034

Director, Office of Information Technology

Ginger Leo (301) 827-1368

Director, Office of Communication, Outreach and Development

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) 827-5102

Director, Office of Compliance & Biologics Quality

Mary Anne Malarkey (301) 827-6190

Director, Division of Inspections and Surveillance

Gilliam Conley (301) 827-6220

Director, Bioresearch Monitoring Branch

Patricia Holobaugh (301) 827-6220

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