CENTER FOR DRUG EVALUATION AND RESEARCH KEY OFFICIALS September 14, 2011 OFFICE OF THE CENTER DIRECTOR

(OCD) DIRECTOR Janet Woodcock, M.D. Executive Assistant Sharnell Ligon Deputy Director for Regulatory Programs Douglas C. Throckmorton, M.D. Deputy Center Director for Clinical Science Robert Temple, MD. Program Support Specialist Janice Shelton

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Associate Director for Planning and Business Informatics Theresa Mullin, Ph.D. 301-796-3422 Office Automation Assistant Kathleen Smith Drug Safety Oversight Board Steven Osborne, M.D. Project Specialist Georgiann Lenzl Associate Director for International Programs Justina A. Molzon, J.D. Ombudsman Virginia Behr Controlled Substance Staff Michael Klein, Ph.D. Supervisory Senior Management Officer Vacant OFFICE OF PHARMACEUTICAL SCIENCE (OPS) Director Helen Winkle Deputy Director

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Keith Webber Technical Information Specialist Vera Viehmann Director, Operations Staff Kerry Murphy Director, Science and Research Staff Nakissa Sadrieh, Ph.D. Director, New Drug Microbiology Staff David Hussong, Ph.D. Scientific Coordinator Russell Wesdyk, M.B.A. Associate Director for Policy Development Jon Clark OFFICE OF BIOTECHNOLOGY PRODUCTS (OBP) Director Steven Kozlowski, M.D. Deputy Director Vacant Associate Director of Medical Affairs Kenneth Hyams, M.D., M.P.H. Associate Director for Operations Marilyn Welschenbach, Ph.D. Management Officer James Selby, Jr.

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Division of Monoclonal Antibodies (DMA) Director Kathleen Clouse, Ph.D. Deputy Director Patrick Swann, Ph.D.

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HFD-123

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Division of Therapeutic Proteins (DTP) Director Amy Rosenberg, M.D.

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Deputy Director Barry Cherney, Ph.D.

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OFFICE OF TESTING AND RESEARCH (OTR) Director Vincent Vilker, Ph.D. Deputy Director Vacant Associate Director for Research Policy Joseph Hanig Management Officer Derek Hicks (Acting) Management Specialist Geoff Salyer Laboratory of Clinical Pharmacology (LCP) Director Thomas Colatsky, Ph.D. (Acting)

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Division of Applied Pharmacology Research (DAPR) Director Thomas Colatsky, Ph.D.

301-796-0078

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Deputy Director Vikram Patel Program Specialist Yolanda J. Sanders

301-796-0121

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301-796-0012

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Division of Product Quality Research (DPQR) Director Mansoor Khan, Ph.D. Deputy Director Tasheen Mirza Division of Pharmaceutical Analysis (DPA) Director Lucinda F. Buhse, Ph.D.

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1114 Market St. Rm 1002 St. Louis, MO 63101

Deputy Director Benjamin Westenberger

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1114 Market St. Rm. 1002 St. Louis, MO 63101

OFFICE OF GENERIC DRUGS (OGD) Director Keith Webber (Acting)

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Technical Information Specialist Patricia Downs HFD-600 Deputy Director Robert West, R.Ph. Director for Science Lawrence Yu, Ph.D.

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HFD-600

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Associate Director for Medical Affairs Dena Hixon, M.D. HFD-600 Associate Director for Chemistry Frank O. Holcombe, Jr., Ph.D. HFD-600

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Associate Director for Operations and Communications Rita Hassall, R.N. HFD-600 240-276-9310 Management Officer Patricia Littleton Division of Chemistry I (DCI) Director Paul Schwartz, PhD. (Acting) Deputy Director Vacant Division of Chemistry II (DCII) Director Glen Smith , Ph.D. (Acting) Deputy Director Glen Smith, Ph.D. (Acting) Division of Chemistry III (DCIII) Director Vilayat Sayeed, Ph.D.

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Deputy Director Devinder Gill

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Division of Bioequivalence (DB) Director Dale Conner, Pharm.D. Deputy Director Barbara Davit, Ph.D.

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Division of Labeling and Program Support (DLPS) Director Peter Rickman

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Deputy Director Vacant OFFICE OF NEW DRUG QUALITY ASSESSMENT (ONDQA) Director Moheb Nasr, Ph. D. Technical Information Specialist Patricia OConnor Deputy Director (Science and Policy) Christine Moore, Ph.D. Deputy Director (Review and Operations) Elaine Morefield

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Associate Director for Regulatory Science and Policy John Smith, Ph.D. 301-796-1757 Associate Director for Product Quality- Urgent Response Norm Schmuff, Ph.D. (Acting) 301-794-1454 Associate Director for Regulatory Affairs Michael Folkendt BioPharmaceutics Lead Patrick Marroum, PhD. Program Manager David Morley Management Officer Shanell Owens

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Division of New Drug Quality Assessment I (DNDQA I) Director Richard Lostritto, Ph.D. Branch Chief, Branch I Ramesh Sood, PhD.

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Branch Chief, Branch II Sarah Pop-Miksinski, Ph.D. Branch Chief, Branch III Hasmukh Patel, PhD.

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Division of New Drug Quality Assessment II (DNDQA II) Director Terry Ocheltree, PhD. Branch Chief, Branch IV Moo Jhong Rhee, PhD. Branch Chief, Branch V Rapti Madurawe Branch Chief, Branch VI Tom Oliver, PhD,

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Division Of New Drug Quality Assessment III (DNQAIII) Director Eric Duffy, Ph.D. Branch Chief, Branch VII Ali Al-Hakim, PhD. Branch Chief, Branch VIII Prasad Peri, PhD. Branch Chief, Branch IX Jim Vidra, PhD. OFFICE OF REGULATORY POLICY (ORP) Director Jane A. Axelrad, J.D. Deputy Associate Director for Policy Denise Esposito

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Special Assistant Michael D. Jones Management Officer Michelle Bacon Program Support Specialist Paula Fidel-Aitken Division of Regulatory Policy I (DRPI) Director Nancy Boocker, J.D. Division of Regulatory Policy II (DRPII) Director Michael Bernstein, J.D. Division of Regulatory Policy III (DRPIII) Director Nam Kim, J.D.

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Division of Information Disclosure Policy (DIDP) Director Nancy Sager OFFICE OF EXECUTIVE PROGRAMS (OEP) Director Deborah Henderson Deputy Director Jayne Ware Directors Secretary Breana McLaren Executive Operations Staff Christine Bechtel Advisors and Consultants Staff Jayne Peterson Management Officer Melanie Whalen OFFICE OF MANAGEMENT (OM)

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Director Melanie Keller Secretary Jeff Kuti Deputy Director Edwin Echgoyen Management Officer Rebecca E. Glidden Division of Management and Budget (DMB) Director Rixie Scott Deputy Director Katie Green Planning and Resource Management Branch Kevin Laser HFD-050 Management Analysis Branch Don Kim

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Division of Management Services (DMS) Director Mary Milline Deputy Director Tania Tse

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Program Management Services Branch Patricia Gathers HFD-065

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Interface Management Branch (IMB) Thomas Murphy HFD-067 OFFICE OF NEW DRUGS (OND) Director John Jenkins, M.D. Executive Assistant Victor Vail Deputy Director

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RADM Sandra Kweder, MD.

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Senior Management Officer, Program Management Analysis Staff Eldridge Coles 301-796-0141 WO 22/Rm. 6418 Associate Director, Pharmacology and Toxicology David Jacobson-Kram, Ph.D., D.A.B.T. 301-796-0175 Associate Director, Regulatory Affairs Lina AlJuburi, PharmD. (Acting)

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Associate Director, Study Endpoints & Labeling Development CAPT. Laurie Burke, R.Ph., M.P.H 301-796-0900 Associate Director, Pediatric & Maternal Health Staff Lisa Mathis, M.D. 301-796-2200 Associate Director, Guidance/Policy Team Sally Loewke, M.D. Associate Director, Rare Disease Program Anne Pariser, MD. Associate Director, Biosimilars Program Leah Christl, PhD.

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Associate Director, Learning and Career Development Susanne Walker 301-796-5229 Associate Director, Safety Policy and Research Mwango Kashoki, MD. 301-796-1238

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OFFICE OF DRUG EVALUATION I (ODEI) Director Robert J. Temple, M.D. (Acting) Assistant Aprile Blount Deputy Director Dr. Ellis Unger Associate Director for Regulatory Affairs Colleen LoCicero Management Officer Andrea Ferentinos

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Division of Cardiovascular Renal Products (DCRP)

Director Norman Stockbridge, M.D., Ph.D. Deputy Director Stephen Grant, M.D. Supervisory Project Manager Edward Fromm Division of Neurology Products (DNP) Director Russell G. Katz, M.D. Deputy Director Eric Bastings, M.D. Supervisory Project Manager Robbin Nighswander, R.Ph. Jacqueline Ware, R.Ph.

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Division of Psychiatry Products (DPP) Director Thomas Laughren, M.D. Deputy Director Mitchell Mathis, M.D. Supervisory Project Managers Steven Hardeman, R.Ph. Paul David, R.Ph. OFFICE OF DRUG EVALUATION II (ODEII) Director Curtis Rosebraugh, M. D. Secretary Velma Cunningham Deputy Director Vacant Associate Director for Regulatory Affairs Leah Ripper Management Officer

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Thomas Cunningham

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Division of Metabolism and Endocrinology Products (DMEP) Director Mary Parks, M.D. Deputy Director Eric Colman, M.D. Supervisory Project Managers Enid M. Galliers Lina Aljuburi

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Division of Pulmonary and Allergy Products (DPAP) Director Badrul Chowdhury, M.D. Deputy Director Lydia Gilbert-McClain, M.D. Supervisory Project Manager Sandra L. Barnes

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Division of Analgesics, Anesthetics, and Rheumatology Products (DAARP) Director Bob A. Rappaport, M.D. Deputy Director Sharon Hertz, M.D. Deputy Director Rigoberto Roca, M.D. Supervisory Project Managers Parinda Jani Sara Stradley OFFICE OF DRUG EVALUATION III (ODEIII) Director Julie Beitz, M.D. Program Support Specialist Diane Thomas

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Deputy Director Vacant Associate Director for Regulatory Affairs Maria Walsh Management Officer Antoinette Mason

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Division of Reproductive and Urologic Products (DRUP) Director Scott Monroe, M.D. Deputy Director George Benson, M.D. Supervisory Project Managers Margaret Kober Jennifer Mercier

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Division of Gastroenterology Products (DGP) Director Donna Griebel, M.D. Deputy Director Andrew Mulberg Supervisory Project Managers Richard Wes Ishihara Brian Strongin

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Division of Dermatology and Dental Products (DDDP) Director Susan Walker, M.D. Deputy Director Stanka Kukich, M.D. Supervisory Project Manager Barbara Jean Gould

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OFFICE OF ANTIMICROBIAL PRODUCTS (OAP) Director Edward Cox, M.D., M.P.H. Deputy Director

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John J. Farley, M.D., M.P.H.

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Associate Director for Regulatory Affairs David Roeder Management Officer Dana Schuhly Division of Anti-Infective Products (DAIP) Director John Farley, M.D., M.P.H. Deputy Director Katherine Laessig, M.D. Supervisory Project Managers Frances LeSane Maureen Dillon-Parker Division of Anti-Viral Products (DAVP) Director Debra Birnkrant, M.D. Deputy Director Jeffrey Murray, M.D., MPH Supervisory Project Managers Victoria Tyson Karen Winestock

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Division Transplant and Ophthalmology Products (DTOP) Director Renata Albrecht, M.D. Deputy Director Wiley A. Chambers, M.D. Supervisory Project Manager Diana Willard Supervisory Project Manager Judit Milstein OFFICE OF DRUG EVALUATION IV (ODEIV) Director Charles J. Ganley, M.D.

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Secretary Norma Jiggetts Deputy Director Shaw T. Chen, M.D. Associate Director for Regulatory Affairs Vacant Associate Director Susan Johnson, Pharm.D., Ph.D.

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Management Officer Merla Rae Matheny

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Division of Nonprescription Clinical Evaluation (DNCE) Director Andrea Leonard-Segal, M.D. Deputy Director Joel Schiffenbauer, M.D. Program Specialist Pamela Hampton (Acting)

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Division of Nonprescription Regulation Development (DNRD) Director M. Scott Furness, Ph.D. Deputy Director Debbie Lumpkins Program Specialist (Acting) Merla Rae Matheny

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Division of Medical Imaging Products (DMIP) Director Rafel (Dwaine) Rieves, M.D. Secretary Vacant Deputy Director Libero Marzella, M.D. Supervisory SCO Kyong Kang

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Program Specialist Crystal Coulter

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OFFICE OF HEMATOLOGY AND ONCOLOGY PRODUCTS (OHOP) Director Richard Pazdur, M.D. Project Specialist Bertha Mejia Deputy Director Vacant Associate Director for Regulatory Affairs Tamy Kim (Acting) Associate Director for Regulatory Science Anthony Murgo, M.D. Management Officer Krista Yazdani Division of Oncology Products (DOP 1) Director Robert Justice, MD. Secretary Temitayo Lewis Deputy Director Amna Ibrahim, MD. Supervisory CSO Frank Cross Alice Kacuba Division of Oncology Products (DOP 2) Director Patricia Keegan, MD. Secretary Barry Littleton Deputy Director Joseph Gootenberg, MD. Supervisory CSO

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Karen Jones Division of Hematology Products (DHP) Director Ann Farrell, M.D. Secretary Vacant Deputy Director Edvardas Kaminskas, M.D. (Acting) Supervisory CSO Janet Jamison

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Division of Hematology Oncology Toxicology Products (DHOT) Director John Leighton (Acting) Secretary Vacant Deputy Director Vacant OFFICE OF SURVEILLANCE AND EPIDEMIOLOGY (OSE) Director Gerald Dal Pan, M.D., M.H.S. (Acting) Program Support Specialist Barbara M. McCary Deputy Director Henry Francis, M.D. (Acting) Supervisory Senior Management Officer Amy Garvin Outreach Staff Director Cheryl Campbell Project Management Staff (PMS) Staff Director Sammie Beam (Acting)

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Office of Pharmacovigilance & Epidemiology (OPE) Director Gerald Dal Pan, M.D., M.H.S Deputy Director Henry Frances, M.D. Division of Pharmacovigilance I (DPV I) Director Linda Scarazzini Deputy Director Vacant

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Division of Pharmacovigilance II (DPV II) Director Vacant Deputy Director Bindi Nikhar, M.D. Division of Epidemiology (DEPI) Director Solomon Iyasu, M.D., M.P.H. Deputy Director Tarek Hammad, MD. Division of Epidemiology II (DEPI II) Director Judy Staffa, Ph.D. Deputy Director Laura Governale

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Office of Medication Error Prevention and Risk Management (OMEPRM) Director Vacant Deputy Director Vacant Division of Risk Management (DRISK)

Director Claudia Karwoski, Pharm. D. Deputy Director Mary Willy, Pharm. D. (Acting)

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Division of Medication Errors Prevention and Analysis (DMEPA) Director Carol Holquist, R.Ph. Deputy Director Vacant OFFICE OF TRANSLATIONAL SCIENCES (OTS) Director ShaAvhree Buckman, M.D., Ph.D., F.A.A.P. Program Support Specialist Kiesha Houston Deputy Director Susan McCune (Acting) Supervisory Senior Management Officer Raya S. McCree Associate Director for Regulatory Affairs Rubynell Jordan, BSN, MPA Research Coordinator CAPT Frances T. Gipson Associate Director for Science Jan Johannessen OFFICE OF BIOSTATISTICS (OB) Director Robert ONeill, Ph.D. Program Support Specialist Shereese Johnson (Acting) Deputy Director Edward Nevius, Ph.D. Associate Director Sue Jane Wang, Ph.D.

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Associate Director for Statistical Science & Policy Ram Tiwari 301-796-4084 Management Officer Lisa Gilmer Division of Biometrics I (DBI) Director James Hung, Ph.D. Deputy Director Kooros Mahjoob, Ph.D. Division of Biometrics II (DBII) Director Thomas Permutt, Ph.D. Deputy Director Jon Sahlroot Division of Biometrics III (DBIII) Director Stephen Wilson, Ph.D. Division of Biometrics IV (DBIV) Director Mohammad Huque, Ph.D. Deputy Director Daphne Lin, Ph.D. Division of Biometrics V (DBV) Director Aloka G. Chakravarty, Ph.D. Deputy Director Rajeshwari Sridhara Division of Biometrics VI (DBVI) Director Stella Machado, Ph.D. Deputy Director Yi Tsong

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301-796-1115

WO 21/Rm. 4614

301-796-1271

WO 21/Rm. 3614

301-796-1286

WO 21Rm. 3612

301-796-0579

WO 21/Rm. 3630

301-796-1800

WO 21/Rm. 3510

301-796-0751

WO 21Rm. 3508

301-796-1655

WO 21/Rm. 3514

301-796-1759

WO 21/Rm. 3512

301-796-0949

WO 21/Rm. 4630

301-796-1013

WO 21/Rm. 4628

OFFICE OF CLINICAL PHARMACOLOGY (OCP) Director Lawrence J. Lesko, Ph.D. Program Support Specialist Karen Graves Deputy Director Shiew-Mei Huang, Ph.D. Associate Director of Genomics Issam Zineh, Pharm.D. Pharmacometrics Staff Jogarao Gobburu, Ph.D. Management Officer Malcom Dennis Division of Clinical Pharmacology I (DCPI) Director Mehul Mehta, Ph.D. Deputy Director Ramana S. Uppoor Division of Clinical Pharmacology II (DCPII) Director Chandra Sahajwalla Deputy Director Suresh Doddapaneni

301-796-1565

WO 51/Rm. 3178

301-796-5008

WO 51/Rm. 3177

301-796-1541

WO 51/Rm. 3188

301-796-4756

WO 51/Rm. 3182

301-796-1589

WO 51/Rm. 3186

301-796-4107

WO 21/Rm. 4508

301-796-1573

WO 51/Rm. 2178

301-796-1619

WO 51/Rm. 2182

301-796-1599

WO 51/Rm. 4550

301-796-1526

WO 51/Rm. 3136

Division of Clinical Pharmacology III (DCPIII) Director Dennis Bashaw, Ph.D. Deputy Director Hae Young Ahn

301-796-1502

WO 51/Rm. 3134

301-796-1494

WO 51/Rm. 3132

Division of Clinical Pharmacology IV (DCPIV) Director John A. Lazor, Pharm.D. Deputy Director Kellie Reynolds

301-796-1559

WO 51/Rm. 2134

301-796-1594

WO 51/Rm.2142

Division of Clinical Pharmacology V (DCPV) Director Atik Rahman, Ph.D. Deputy Director Brian Booth OFFICE OF MEDICAL POLICY (OMP) Director Rachel E. Sherman, M.D. Assistant Laura Myers Deputy Director Kathleen Uhl, M.D. Associate Director for Regulatory Affairs Janet Norden Senior Management Officer Tammy Russell Office of Prescription Drug Promotion Director Thomas W. Abrams, RPh, MBA Deputy Director Vacant Division of Direct of-Consumer Promotion Director Vacant Deputy Director Vacant Division of Professional Promotion Director Vacant Deputy Director Vacant Office of Medial Policy Initiative

301-796-1591

WO 51/Rm. 2188

301-796-1508

WO 51/Rm. 2186

301-796-2500

WO 51/Rm. 6338

301-796-2500

WO 51/Rm. 6337

301-796-2500

WO 51/Rm. 6342

301-796-2500

WO 51/Rm. 6324

301-796-2500

WO 51/Rm. 6332

301-796-1200

WO 51/Rm. 3264

Director CMDR Denise M. Hinton Deputy Director Vacant Associate Director for Regulatory Affairs Melissa Robb Division of Medical Policy Development Director Paula McKeever Deputy Director Vacant Division of Medical Policy Programs Director CMDR Richardae Araojo Deputy Director Vacant

301-796-1090

WO 51/Rm. 6348

301-796-5227

WO 51/Rm. 6360

301-796-8499

WO 51/Rm. 6358

301-796-1152

WO 51/Rm. 2218

OFFICE OF PLANNING & INFORMATICS (OPI) Director Theresa Mullin, Ph.D. Deputy Director Mary Ann Slack Executive Assistant Angela Kwon Supervisory Senior Management Officer Maria Andrews Office of Planning & Analysis (OPA) Director Theresa Mullin, Ph.D. (Acting) Management Officer Kathleen Tchoulakian Analysis Staff (AS) Staff Director 301-796-3800 WO 51/Rm. 1178

301-796-0603

WO 51/Rm. 1188

301-796-4957

WO51/Rm. 1183

301-796-2273

WO 51/Rm. 1184

301-796-3800

WO51/Rm. 1178

301-796-0570

WO 51/Rm. 1195

Marta Wosinska, Ph.D. Planning & Evaluation Staff (PES) Staff Director Sunanda Bahl Office of Business Informatics (OBI) Director Hilmar Hamann, PhD. Deputy Director Gary Gensinger Administrative Assistant Julie Quinonez

301-796-3673

WO 51/Rm. 1186

301-796-3584

WO 51/Rm. 1162

301-796-1000

WO 22/Rm. 1124

301-796-0589

WO 22/Rm. 1112

301-796-0282

WO 22/Rm. 1135

Management Officer Denise Townsend

301-796-2112

WO 22/Rm. 1122

Computations Science Center Support Team Technical Architect Binh Ta Division of Project Development (DPD) Division Director Linda Sigg

301-796-4010

WO 22/Rm. 1128

301-796-0625

WO 22/Rm. 1114

Business Informatics Collaboration Team (BICT) William Taylor 301-796-0628 Business Analysis Requirement Team (BART) Amy Gomez 301-796-0322 Division of Business Analysis & Reporting (DBAR) Division Director Yashika Rahaman Reports Management Team (RMT) Michael Cu Data Retrieval and Analysis Team (DRAT) Nancy Maizel

WO 22/Rm. 1175

WO 22/Rm. 1123

301-796-3843

WO 22/Rm. 1110

301-796-0582

WO 22/Rm. 1237

301-796-0607

WO 22/Rm. 1209

Division of Regulatory Review Support (DRRS)

Division Director Mark Gray eSubmission Support Team (eSST) Virginia Hussong eReview Support Team (eRST) Samantha Gordon

301-796-2081

WO 22/Rm. 1132

301-796-1016

WO 22/Rm. 1161

301-796-4894

WO22/Rm. 1219

Division of Records Management (DRM) Division Director Gary Gensinger (Acting) Records Management Team (RMT) Franklin Stephenson

301-796-0589

WO 22/Rm. 1112

301-796-3872

WO 22/Rm. 1189

Document Room Management Team (DRMT) Mia Prather 301-796-0618 OFFICE OF COMMUNICATIONS (OCOMM) Director Julie Zawisza Program Support Specialist Brenda Adams Deputy Director Kimberly Rawlings Management Officer Kelly Phelan

WO 22/Rm. 1133

301-796-3700

Hillandale/Rm. 1126

301-796-2015

Hillandale/Rm. 1124

301-796-3818

Hillandale/Rm. 1146

301-796-3176

Hillandale/Rm. 1144

Division of Training and Development (DTD) Moved to OEP Director Janice Newcomb Deputy Director Virginia Giroux Division of Public Affairs (DPA) Director Anthony E. Sims (Acting) Project Specialist

301-796-3178

WO 51/Rm. 2358

301-796-3179

WO 51/Rm. 2362

301-796-3121

Hillandale/ Rm. 4170

Paul G Neff Deputy Director Anthony E. Sims Division of Drug Information (DDI) Director Barry Poole Deputy Director Mary Kremzner Division of Information Services (DIS) Director Paul Buckman Deputy Director Sally Winthrop OFFICE OF COMPLIANCE (OC) Director Ilisa Bernstein, PharmD., JD. (Acting) Executive Assistants Marlene Sue Ling William Harris Paula Simmons Deputy Director for Program Operations Jennifer Devine, JD. (Acting) Deputy Director for Policy & Analysis Douglas Stearn, Esq.

301-796-3123

Hillandale/Rm. 4168

301-796-3126

Hillandale/Rm. 4170

301-796-3145

Hillandale/Rm. 4130

301-796-3144

Hillandale/Rm. 4150

301-796-3135

Hillandale/Rm. 1106

301-796-3135

Hillandale/Rm. 1122

301-796-4723

WO 51/Rm. 5270

301-796-3361 301-796-2821 301-796-6229

WO 51/Rm. 5269 WO 51/Rm. 5271 WO 51/Rm. 5271

301-796-3363

WO 51/Rm. 5266

301-796-3100

WO 51/Rm 5276

Associate Director of Scientific and Medical Affairs Vacant Associate Director for Risk Science, Intelligence & Prioritizing H. Gregg Claycamp, M.S., Ph.D. (Acting) 301-796-3130 Associate Director of Organizational Strategy Kristi Hampton-Thurston (Acting) 301-796-3238 Senior Advisor Vacant Associate Director for Business Administration Collin Figueroa 301-796-5802

WO 51/Rm. 4266

WO 51/Rm. 5276

WO 51/Rm 1142

Lead Management Officer Karen Kirchberg Contract Specialist Joan Ginetis Regulatory Counsels Meredith Francis, Esq. Harry Schwirck, Esq. Ann Metayer, Esq. Senior Communications Advisor Judy Leon Project Management Officers George Smith Milinda Soukup Brenda Woods-Francis Executive Communications Team Kim Brown Margaret Cole Senior Advisor for Regulatory Science Vacant

301-796-3233

WO 51/Rm. 4274

301-796-4624

WO 51/Rm. 5250

301-796-3476 301-796-4271 301-796-3324

WO 51/Rm. 5258 WO 51/Rm. 5286 WO 51/Rm. 5212

301-796-4624

WO 51/Rm. 5250

301-796-3205 301-796-1444 301-796-3647

WO 51/Rm. 5284 WO 51/Rm. 4320 WO 51/Rm. 5281

301-796-4292 301-796-3966

WO 51/Rm. 5208 WO 51/Rm. 5206

Office of Unapproved Drugs and Labeling Compliance (OUDLC) Director Kathleen Anderson, PharmD. (Acting)

301-796-3309

WO 51/Rm. 5182

Associate Director for Policy and Communication Gail Bormel (Acting) 301-796-3263

WO 51/Rm. 5186

Associate Director for Program Management and Organizational Strategy Akilah Green (Acting) 301-796-1219 WO 51/Rm. 5166 Associate Director for Risk Science, Intelligence and Prioritization Meghan Murphy (Acting) 301-796-3307

WO 51/Rm. 5178

Senior Medical Advisor Charlie Lee Senior Advisor Bob Heller (Acting) Project Management Officers Alisea Crowley

301-796-1244

WO 51/Rm. 5184

301-796-3353

WO 51/Rm. 5246

301-796-1144

WO 51/Rm. 5196

Division of Non-Prescription Drugs and Health Fraud Elizabeth Miller 301-796-3342

WO 51/Rm. 5176

Over the Counter Drugs Branch Anuj Shah (Acting) Health Fraud and Consumer Outreach Branch Vacant Health Fraud and Consumer Outreach Team Brad Pace (Acting Team Leader) Division of Prescription Drugs Judy McMeekin (Acting) Prescription Drugs Branch Sakineh Walther (Acting)

301-796-2246

WO51/Rm. 5104

301-796-3538

WO 51/Rm. 5171

301-796-3344

WO 51/Rm. 5237

301-796-3349

WO 51/Rm. 5242

Marketed Unapproved Drugs Enforcement Team Tia Harper-Velazquez (Acting) 301-796-3301

WO 51/Rm. 5171

Marketed Unapproved Drugs-Regulatory Status & Labeling Team Kim Simmons (Acting) 301-796-3684 WO 51/Rm. 4212 Compounding and Pharmacy Practices Branch Vacant Compounding and Pharmacy Practice Team Ian Deveau (Acting)

301-796-5061

WO 51/Rm. 5198

Office of manufacturing and Product Quality (OMPQ) Director Steve Lynn (Acting) Deputy Director Michael Smedley (Acting)

301-796-3315

WO 51/Rm. 4360

301-796-3273

WO 51/Rm. 4348

Associate Director for Program Management & Organizational Strategy Kennerly K. Chapman 301-796-3271 WO 51/Rm. 4346 Associate Director for Risk Science Intelligence & Prioritization Rick Friedman (Acting) 301-796-3268 Associate Director for Policy & Communication Brian Hasselbalch (Acting) 301-796-3279 Associate Director for Drug Quality Assurance Vacant Senior Advisor Helen Saccone (Acting) Project Management Officers (co-located)

WO 51/Rm. 4342

WO 51/Rm. 4364

301-796-3647

WO 51/Rm. 5283

Kennerly Chapman Helen Saccone, PharmD. Keith Olin, PharmD. Regulatory Counsel H. Joy Sharp

301-796-3271 301-796-4758 301-796-0962

WO 51/Rm. 4346 WO 51/Rm. 4228 WO 51/Rm. 4355

301-796-3647

WO 51/Rm. 4326

Division of Good Manufacturing Practice Assessment Director Barry Rothman

301-796-3281

WO 51/m. 4372

New Drug Manufacturing Assessment Branch Branch Chief Davud Doleski (Acting) 301-796-2627 Generic Drug Manufacturing Assessment Branch Branch Chief Concepcion Cruz (Acting) 301-796-3254 Biotech Manufacturing Assessment Branch Branch Chief Patricia Hughes (Acting)

WO 51/Rm. 4372

WO 51/Rm. 4316

301-796-3189

WO 51/Rm. 4328

Division of Domestic Drug Quality Director Teddi Lopez (Acting) Domestic Compliance Branch 1 Branch Chief Vacant Domestic Compliance Branch 2 Branch Chief David Jaworski (Acting) Division of International Drug Compliance Director Carmelo Motta (Acting) International Compliance Branch 1 Branch Chief Rosa Motto (Acting) International Compliance Branch 2 Branch Chief Vacant

301-796-3255

WO 51/Rm. 4368

301-796-3192

WO 51/Rm. 4242

301-796-3367

WO 51/Rm. 4240

301-796-3283

WO 51/Rm. 4368

Division of Policy, Collaboration & Data Operations Director

Vacant Regulatory Policy & Collaboration Branch Branch Chief Grace McNally (Acting) Drug Surveillance & Data Reporting Branch Branch Chief Elise Murphy (Acting) Drug Quality Reporting System Direct Line

301-796-3286

WO 51/Rm. 4374

301-796-7565

WO 51/Rm. 4272

301-796-3140

Drug Registration and Listing System (DRLS) 301-796-3130

Office of Scientific Investigations (OSI) Director Leslie Ball, M.D. (Acting) Deputy Director Thomas Moreno (Acting)

301-796-3150

WO 51/Rm. 5342

301-796-2247

WO 51/Rm. 5278

Associate Director for Risk Science, Intelligence & Prioritizing Ann Meeker- OConnell (Acting) 301-796-7615 Associate Director for Policy and Communication Karena Cooper (Acting) 301-796-1612

WO 51/Rm. 5339

WO 51/Rm. 5252

Associate Director for Program Management and Organizational Strategy Tanya Clayton (Acting) 301-796-0871 WO 51/Rm. 2224 Division of Safety Compliance Kevin Prohaska (Acting) Post Market Safety Branch Suzanne Barone (Acting) Human Subject Protection Branch Pay McNeilly (Acting) Div. of Good Clinical Practice Compliance Tejashri Purohit-Sheth, M.D. (Acting)

301-796-3707

WO 51/Rm. 5356

301-796-3224

WO 51/Rm. 4258

301-796-2947

WO 51/Rm. 2266

301-796-3402

WO 51/Rm. 5358

Good Clinical Practice Branch Enforcement Branch Constance Lewin, MD. (Acting) 301-796-3397 Good Clinical Practice Assessment Branch Jean Mulinde (Acting)

WO 51/Rm. 5354

301-796-0768

WO 51/Rm. 5318

Div. of Good Laboratory Practice and Bioequivalence Investigations Joseph Salewski (Acting) 301-796-3395 WO 51/Rm 5348 Associate Director for Bioequivalence & Good Laboratory Practice CT Viswanathan, PhD. 301-796-3394 WO 51/Rm. 5346 Bioequivalence Branch Sam Haidar Good Laboratory Practice Team Charles Bonapace (Acting)

301-796-4777

WO 51/Rm. 5330

301-796-1507

WO 51/Rm. 5228

OFFICE OF COUNTER-TERRORISM AND EMERGENCY COORDINATION (OCTEC) Director Rosemary Roberts, M.D. Deputy Director Brad Leissa, M.D. Management Analyst Pilar Martinez Program Support Specialist Vacant Assoc. Dir. Emergency Risk Communication Thomas J. Christle

301-796-2210

WO 51/Rm. 3342

301-796-2210

WO 51/Rm. 3348

301-796-1756

WO 51/Rm. 3346

301-796-2057

WO 51/Rm. 3358

Associate Director of Emergency Coordination Susan McDermott, M.D. 301-796-1121 Associate Director for Regulatory Affairs Joanne Holmes, R.Ph. Management Officer Karen D. Smith

WO 51/Rm. 3362

301-796-1681

WO 51/Rm. 3352

301-796-1756

WO 51/Rm. 3334