U.S. Departments and Offices

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