U.S. Departments and Offices

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