U.S. Departments and Offices

December 1, 2005
Jill Wechsler

Jill Wechsler is ACT's Washington Editor

Applied Clinical Trials

Applied Clinical Trials, Applied Clinical Trials-12-01-2005, 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

Bernard Schwetz (240) 453-6900

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

Deputy Commissioner for Operations

Janet Woodcock (301) 827-3310

Deputy Commissioner for International and Special Programs

Murray Lumpkin (301) 827-5709

Deputy Commissioner for Medical and Scientific Affairs

Scott Gottlieb (301) 827-9776

Chief Staff Officer and Associate Commissioner for Legislation

Patrick Ronan (301) 827-0087

Chief Counsel

Sheldon Bradshaw (301) 827-1137

Senior Associate Commissioner for Policy, Planning

Randall Lutter (301) 827-5292

Associate Commissioner for Science

Norris Alderson (301) 827-3340

Assistant Commissioner for Science

Linda Tollefson (301) 827-3340

Associate Commissioner for External Relations

Jason Brodsky* (301) 827-3330

Associate Commissioner for Planning

Theresa Mullin (301) 827-5292

Associate Commissioner, Office of International Programs

Melinda Plaisier (301) 827-4480

Associate Commissioner for Management

Kathleen Heuer (301) 255-6762

Associate Commissioner for Crisis Management

Ellen Morrison (301) 827-5660

Assistant Commissioner for Counterterrorism Policy

Boris Lushniak (301) 827-4067

Assistant Commissioner for Special Health Issues

Theresa Toigo (301) 827-4460

Director, Office of Orphan Products Development

Marlene Haffner (301) 827-3666

Director, Office of Pediatric Therapeutics

Dianne Murphy (301) 827-9218

Director, Office of Combination Products

Mark Kramer (301) 427-1934

Senior Advisor for Clinical Science and Director, Good Clinical Practice Program

David Lepay (301) 827-3340

Special Assistant to the Director

Patricia Beers Block (301) 827-3340

Associate Director for Bioresearch Monitoring

Stan Woollen (301) 827-3340

Associate Director for Human Subject Protection Policy

Bonnie Lee (301) 827-3340

Expert Consumer Safety Officer

Carolyn Hommel (301) 827-3340

Office of Regulatory Affairs

Associate Commissioner for Regulatory Affairs

Margaret Glavin (301) 827-3101

Senior Advisor for Clinical Science

Lori Love (301) 827-3684

Center for Devices and Radiological Health

Director

Daniel Schultz (301) 827-7975

Deputy Director

Linda Kahan (301) 827-7975

Director, Office of Device Evaluation

Donna Bea Tillman (301) 594-2022

Director, Office of Compliance

Timothy Ulatowski (301) 276-0100

Director, Division of Bioresearch Monitoring

Michael Marcarelli (301) 276-0125

Center for Drug Evaluation and Research (CDER)

Director

Steven Galson (301) 594-5400

Deputy Director

Douglas Throckmorton (301) 594-5400

Scientific Advisor

Donald Stanski (301) 827-5443

Associate Director for Medical Informatics

Randy Levin (301) 827-7784

Associate Director for Regulation and Policy

Jane Axelrad (301) 594-5400

Director, Office of Executive Programs

Deborah Henderson (301) 594-5400

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

Margo Burnette (301) 827-6240

Director, Office of Counter-Terrorism and Pediatric Drug Development

Rosemary Roberts (301) 827-7777

Director, Office of Compliance

Joseph Famulare (301) 827-8910

Director, Office of Clinical Pharmacology and Biopharmaceutics

Lawrence Lesko (301) 594-5690

Office of Medical Policy

Director

Robert Temple (301) 796-2270

Deputy Director

Rachel Behrman (301) 796-2270

Director, Division of Scientific Investigations

Joanne Rhoades (301) 594-0020

Deputy Director

Joseph Salewski (301) 594-0020

Chief, Good Clinical Practices Branch I

Ni Khin (301) 594-1026

Chief, Good Clinical Practices Branch II

Leslie Ball (301) 594-1032

Chief, GLP/Bioequivalence Investigations Branch

C.T. Viswanathan (301) 594-0163

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

Robert Meyer (301) 796-2310

Director, Office of Drug Evaluation III

Florence Houn (301) 796-2100

Director, Office of Antimicrobial Products

Mark Goldberger (301) 796-1300

Director, Office of Oncology Products

Richard Pazdur (301) 796-2340

Director, Office of Nonprescription Products

Charles Gamley (301) 796-2060

Office of Pharmaceutical Science

Director

Helen Winkle (301) 594-2847

Deputy Director

Keith Webber* (301) 594-2847

Director, Office of New Drug Quality Assessment

Moheb Nasr (301) 827-5918

Director, Office of Generic Drugs

Gary Buehler (301) 827-5845

Director, Office of Testing and Research

Vacant (301) 827-2847

Director, Office of Biotechnology Products

Steven Kozlowski (301) 443-5089

Office of Pharmacoepidemiology and Statistical Science

Director

Paul Seligman (301) 827-6276

Deputy Director

Jonca Bull (301) 827-6276

Director, Office of Drug Safety

Gerald Dal Pan (301) 827-6276

Director, Office of Biostatistics

Robert O'Neill (301) 827-3195

Center for Biologics Evaluation and Research (CBER)

Director

Jesse Goodman (301) 827-0372

Deputy Director for Medicine

Karen Midthun (301) 827-0378

Associate Director for Policy

Diane Maloney (301) 827-0373

Associate Director for Research

Kathryn Carbone (301) 827-0377

Associate Director for Medical and International Affairs

(vacant) (301) 827-0641

Associate Director for Quality Assurance

Sheryl Lard-Whiteford (301) 827-0379

Associate Director for Review Management

Robert Yetter (301) 827-9418

Senior Policy Advisor and Counselor for Biologics

Jill Warner (301) 827-0372

Director, Office of Biostatistics and Epidemiology

Mary Foulkes (301) 827-3034

Director, Office of Communication, Training, and Manufacturers Assistance

Mary Meyer (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 Couley (301) 827-6221

Chief, Bioresearch Monitoring Branch

Patricia Holobaugh (301) 827-6220

*Acting

NIH Institutes, Centers, and Divisions

Director

Elias Zerhouni (301) 496-2433

Deputy Director

Raynard Kington (301) 496-7322

Office of Extramural Research, Acting Deputy Director

Norka Brave (301) 496-1096

Office of Intramural Research, Deputy Director

Michael Gottesman (301) 496-1921

Office of Technology Transfer (OTT), Director

Bonny Harbinger (301) 404-7700

Office for Research on Women's Health (ORWH)

(301) 402-1770

Office of AIDS Research (OAR)

(301) 496-0357

National Cancer Institute (NCI)

(301) 496-6641

National Eye Institute (NEI)

(301) 496-5248

National Heart, Lung, and Blood Institute (NHLBI)

(301) 496-4236

National Human Genome Research Institute (NHGRI)

(301) 402-0911

National Institute on Aging (NIA)

(301) 496-1752

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

(301) 443-3860

National Institute of Allergy and Infectious Diseases (NIAID)

(301) 402-1663

National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

(301) 496-8190

National Institute of Biomedical Imaging and Bioengineering (NIBIB)

(301) 451-4772

National Institute of Child Health and Human Development (NICHD)

(301) 496-5133

National Institute on Deafness and Other Communication Disorders (NIDCD)

(301) 496-7243

National Institute of Dental and Craniofacial Research (NIDCR)

(301) 496-4261

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

(301) 496-3583

National Institute on Drug Abuse (NIDA) (301) 443-1124

National Institute of Environmental Health Sciences (NIEHS)

(919) 541-3345

National Institute of General Medical Sciences (NIGMS)

(301) 496-7301

National Institute of Mental Health (NIMH)

(301) 443-4536

National Institute of Neurological Disorders and Stroke (NINDS)

(301) 496-5751

National Institute of Nursing Research (NINR)

(301) 496-0207

National Library of Medicine (NLM)

(301) 496-6308

Warren Grant Magnuson Clinical Center (CC)

(301) 496-2563

Center for Information Technology (CIT)

(301) 496-6203

National Center for Complementary and Alternative Medicine (NCCAM)

(301) 594-7790

National Center for Research Resources (NCRR)

(301) 435-0888

National Center on Minority Health and Health Disparities (NCMHD)

(301) 435-3481

John E. Fogarty International Center (FIC)

(301) 496-2075

Visitor Information Center

(301) 496-1776