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8/4/2019 Key Officials List
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CENTER FOR DRUG EVALUATION AND RESEARCHKEY OFFICIALS
September 14, 2011
OFFICE OF THE CENTER DIRECTOR (OCD)
DIRECTORJanet Woodcock, M.D. 301-796-5400 WO 51/Rm. 6133
Executive AssistantSharnell Ligon 301-796-5400 WO 51/Rm. 6131
Deputy Director for Regulatory ProgramsDouglas C. Throckmorton, M.D. 301-796-5400 WO 51/Rm. 6132
Deputy Center Director for Clinical ScienceRobert Temple, MD. 301-796-2270 WO 22/Rm. 4212
Program Support Specialist
Janice Shelton 301-796-5400 WO 51/Rm. 6128
Associate Director for Planning and Business InformaticsTheresa Mullin, Ph.D. 301-796-3422 WO 51/Rm. 6338
Office Automation AssistantKathleen Smith 301-796-3429 WO 51/Rm. 6337
Drug Safety Oversight BoardSteven Osborne, M.D. 301-796-3604 WO 51/Rm. 5158
Project SpecialistGeorgiann Lenzl 301-796-3515 WO 51/Rm. 5159
Associate Director for International ProgramsJustina A. Molzon, J.D. 301-796-5400 WO 51/Rm. 6118
OmbudsmanVirginia Behr 301-796-3436 WO 51/Rm. 6158
Controlled Substance StaffMichael Klein, Ph.D. 301-796-5402 WO 51/Rm. 5142
Supervisory Senior Management OfficerVacant
OFFICE OF PHARMACEUTICAL SCIENCE (OPS)
DirectorHelen Winkle 301-796-2400 WO 51/Rm. 4184
Deputy Director
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Keith Webber 301-796-2400 MPN4/Rm. 3020
Technical Information SpecialistVera Viehmann 301-796-1622 WO 51/Rm. 4183
Director, Operations StaffKerry Murphy 301-796-2905 WO 51/Rm. 4134
Director, Science and Research StaffNakissa Sadrieh, Ph.D. 301-796-1598 WO 51/Rm. 4172
Director, New Drug Microbiology StaffDavid Hussong, Ph.D. 301-796-1228 WO 51/Rm. 4166
Scientific CoordinatorRussell Wesdyk, M.B.A. 301-796-1552 WO 51/Rm. 4183
Associate Director for Policy DevelopmentJon Clark 301-796-2400 WO 51/Rm. 4178
OFFICE OF BIOTECHNOLOGY PRODUCTS (OBP)
DirectorSteven Kozlowski, M.D. 301-796-2390 WO 21/Rm. 1510
Deputy DirectorVacant
Associate Director of Medical AffairsKenneth Hyams, M.D., M.P.H. 301-796-4797 WO 21/Rm. 1518
Associate Director for Operations 301-796-1773 WO 21/Rm. 1514Marilyn Welschenbach, Ph.D.
Management OfficerJames Selby, Jr. 301-796-1774 WO 21/Rm. 1516
Division of Monoclonal Antibodies (DMA)
Director
Kathleen Clouse, Ph.D. HFD-123 301-827-0850 NIH 29B RM. 4NN12
Deputy DirectorPatrick Swann, Ph.D. HFD-123 301-827-0850 NIH 29B RM. 3NN10
Division of Therapeutic Proteins (DTP)
DirectorAmy Rosenberg, M.D. HFD-122 301-827-1790 N29A/Rm. 2D16
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Deputy DirectorBarry Cherney, Ph.D. HFD-122 301-827-1790 N29A/Rm. 2D16
OFFICE OF TESTING AND RESEARCH (OTR)
DirectorVincent Vilker, Ph.D. 301-796-0200 WO 22/Rm. 2130
Deputy DirectorVacant
Associate Director for Research PolicyJoseph Hanig 301-796-0079 WO 22/Rm. 2134
Management OfficerDerek Hicks (Acting) 301-796-1213 WO22/Rm. 3145
Management SpecialistGeoff Salyer 301-796-0202 WO 22/Rm. 2128
Laboratory of Clinical Pharmacology (LCP)
DirectorThomas Colatsky, Ph.D. (Acting) 301-796-0078 WO 64/Rm. 2078
Division of Applied Pharmacology Research (DAPR)
DirectorThomas Colatsky, Ph.D. 301-796-0078 WO 64/Rm. 2078
Deputy DirectorVikram Patel 301-796-0121 WO 64/Rm. 2026
Program SpecialistYolanda J. Sanders 301-796-0012 WO 64/ Rm. 2062
Division of Product Quality Research (DPQR)
DirectorMansoor Khan, Ph.D. 301-796-0016 WO 64/Rm. 1006
Deputy DirectorTasheen Mirza 301-796-7645 WO 64/Rm. 1062
Division of Pharmaceutical Analysis (DPA)
DirectorLucinda F. Buhse, Ph.D. HFD-920 314-539-2134 1114 Market St.
Rm 1002St. Louis, MO 63101
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Deputy DirectorBenjamin Westenberger HFD-920 314-539-3869 1114 Market St.
Rm. 1002St. Louis, MO 63101
OFFICE OF GENERIC DRUGS (OGD)
Director Keith Webber (Acting) HFD-600 301-796-2400 MPN4/Rm. 3020
Technical Information SpecialistPatricia Downs HFD-600 240-276-9310 MPN4/Rm. 3010
Deputy DirectorRobert West, R.Ph. HFD-601 240-276-9310 MPN 2/Rm. E283
Director for ScienceLawrence Yu, Ph.D. HFD-600 240-276-9310 MPN4 /Rm. 3014
Associate Director for Medical Affairs
Dena Hixon, M.D. HFD-600 240-276-9310 MPN2/Rm. 2210
Associate Director for ChemistryFrank O. Holcombe, Jr., Ph.D. HFD-600 240-276-9310 MPN2/Rm. N131
Associate Director for Operations and CommunicationsRita Hassall, R.N. HFD-600 240-276-9310 MPN4/Rm. 3019
Management OfficerPatricia Littleton HFD-600 240-276-9322 MPN4/Rm. 3024
Division of Chemistry I (DCI)
DirectorPaul Schwartz, PhD. (Acting) HFD-621 240-276-8500 MPN2/Rm. 206
Deputy DirectorVacant
Division of Chemistry II (DCII)
Director
Glen Smith , Ph.D. (Acting) HFD-640 240-276-8505 MPN2/Rm. E270
Deputy DirectorGlen Smith, Ph.D. (Acting) HFD-640 240-276-8505 MPN2/Rm. E270
Division of Chemistry III (DCIII)
DirectorVilayat Sayeed, Ph.D. HFD-630 240-276-8444 MPN2/Rm. E133
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Deputy DirectorDevinder Gill HFD-630 240-276-8444 MPN2/Rm E134
Division of Bioequivalence (DB)
DirectorDale Conner, Pharm.D. HFD-650 240-276-8782 MPN1/Rm. 1341
Deputy DirectorBarbara Davit, Ph.D. HFD-651 240-276-8782 MPN1/Rm. 1343
Division of Labeling and Program Support (DLPS)
DirectorPeter Rickman HFD-610 240-276-8400 MPN2/Rm. N129
Deputy DirectorVacant
OFFICE OF NEW DRUG QUALITY ASSESSMENT (ONDQA)
Director Moheb Nasr, Ph. D. 301-796-1724 WO 21/Rm. 2630
Technical Information SpecialistPatricia O’Connor 301-796-1727 WO 21/Rm 2691
Deputy Director (Science and Policy)Christine Moore, Ph.D. 301-796-1422 WO 21/Rm 2626
Deputy Director (Review and Operations)Elaine Morefield 301-796-1987 WO 21/Rm. 1442
Associate Director for Regulatory Science and PolicyJohn Smith, Ph.D. 301-796-1757 WO 21/Rm 2619
Associate Director for Product Quality- Urgent ResponseNorm Schmuff, Ph.D. (Acting) 301-794-1454 WO 21/Rm 2526
Associate Director for Regulatory Affairs
Michael Folkendt 301-796-1670 WO 21/Rm 2668
BioPharmaceutics LeadPatrick Marroum, PhD. 301-796-1570 WO 21/Rm 1602
Program ManagerDavid Morley 301-796-1719 WO 21/Rm 2672
Management OfficerShanell Owens 301-796-1729 WO 21/Rm 2677
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Division of New Drug Quality Assessment I (DNDQA I)
DirectorRichard Lostritto, Ph.D. 301-796-1697 WO 21/Rm 1626
Branch Chief, Branch IRamesh Sood, PhD. 301-796-1466 WO 21/Rm 2530
Branch Chief, Branch IISarah Pop-Miksinski, Ph.D. 301-796-1436 WO 21/Rm 1624
Branch Chief, Branch IIIHasmukh Patel, PhD. 301-796-1432 WO 21/Rm. 2616
Division of New Drug Quality Assessment II (DNDQA II)
DirectorTerry Ocheltree, PhD. 301-796-1988 WO 21/Rm. 1609
Branch Chief, Branch IVMoo Jhong Rhee, PhD. 301-796-1440 WO 22/Rm. 1446
Branch Chief, Branch VRapti Madurawe 301-796-1408 WO 22/Rm. 1446
Branch Chief, Branch VITom Oliver, PhD, 301-796-1728 WO 21/Rm. 2518
Division Of New Drug Quality Assessment III (DNQAIII)
DirectorEric Duffy, Ph.D. 301-796-1666 WO 21/Rm 2614
Branch Chief, Branch VIIAli Al-Hakim, PhD. 301-796-1323 WO 21/Rm. 2524
Branch Chief, Branch VIIIPrasad Peri, PhD. 301-796-1730 WO 21/Rm 2558
Branch Chief, Branch IX
Jim Vidra, PhD. 301-796-1767 WO 21/Rm 2620
OFFICE OF REGULATORY POLICY (ORP)
Director Jane A. Axelrad, J.D. 301-796-5400 WO 51/Rm. 6216
Deputy Associate Director for PolicyDenise Esposito 301-796-3600 WO 51/Rm. 6144
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Special AssistantMichael D. Jones 301-796-3602 WO 51/Rm. 6216Management OfficerMichelle Bacon 301-796-3764 WO 51/Rm. 6114
Program Support SpecialistPaula Fidel-Aitken 301-796-3428 WO 51/Rm. 6143
Division of Regulatory Policy I (DRPI)
DirectorNancy Boocker, J.D. 301-796-3601 WO 51/Rm. 6244
Division of Regulatory Policy II (DRPII)
DirectorMichael Bernstein, J.D. 301-796-3602 WO 51/Rm. 6240
Division of Regulatory Policy III (DRPIII)
DirectorNam Kim, J.D. 301-796-3472 WO 51/Rm. 6358
Division of Information Disclosure Policy (DIDP)
DirectorNancy Sager 301-796-3603 WO 51/Rm. 6264
OFFICE OF EXECUTIVE PROGRAMS (OEP)
DirectorDeborah Henderson 301-796-1446 WO 51/Rm. 6148
Deputy DirectorJayne Ware 301-796-3433 WO 51/Rm. 6152
Director’s SecretaryBreana McLaren 301-796-5102 WO 51/Rm. 6145B
Executive Operations StaffChristine Bechtel 301-796-3449 WO 51/Rm. 6186
Advisors and Consultants StaffJayne Peterson HFD-021 301-827-6762 FHSL/Rm. 1084
Management OfficerMelanie Whalen 301-796-4268 WO 51/Rm. 6106
OFFICE OF MANAGEMENT (OM)
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DirectorMelanie Keller 301-796-3300 WO 51//Rm. 5135
SecretaryJeff Kuti 301-796-9653 WO 51//Rm. 5135
Deputy Director
Edwin Echgoyen 301-796-3300 WO 51//Rm. 5135
Management OfficerRebecca E. Glidden 301-796-4417 WO 51/Rm. 5129
Division of Management and Budget (DMB)
DirectorRixie Scott HFD-050 301-796-4405 MM2/Rm. 306
Deputy Director
Katie Green 301-796-4404 MM2/Rm. 307
Planning and Resource Management BranchKevin Laser HFD-050 301-796-3294 MM2I/Rm. 308
Management Analysis BranchDon Kim HFD-050 301-796-4407 MM2/Rm. 309
Division of Management Services (DMS)
Director
Mary Milline HFD-060 301-796-4428 MM2/Rm. 340
Deputy DirectorTania Tse HFD-060 301-796-4453 MM2/Rm. 342
Program Management Services BranchPatricia Gathers HFD-065 301-796-4445 MM2/Rm. 333
Interface Management Branch (IMB)Thomas Murphy HFD-067 301-796-4054 MM2/Rm. 347
OFFICE OF NEW DRUGS (OND)
DirectorJohn Jenkins, M.D. 301-796-0700 WO 22/Rm. 6304
Executive AssistantVictor Vail 301-796-3169 WO 22/Rm. 6305
Deputy Director
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RADM Sandra Kweder, MD. 301-796-0700 WO 22/Rm. 6306
Senior Management Officer, Program Management Analysis StaffEldridge Coles 301-796-0141 WO 22/Rm. 6418
Associate Director, Pharmacology and ToxicologyDavid Jacobson-Kram, Ph.D., D.A.B.T. 301-796-0175 WO 22/Rm. 6488
Associate Director, Regulatory AffairsLina AlJuburi, PharmD. (Acting) 301-796-1168 WO 22/Rm. 6300
Associate Director, Study Endpoints & Labeling DevelopmentCAPT. Laurie Burke, R.Ph., M.P.H 301-796-0900 WO 22/Rm. 6462
Associate Director, Pediatric & Maternal Health StaffLisa Mathis, M.D. 301-796-2200 WO 22/Rm. 6414
Associate Director, Guidance/Policy TeamSally Loewke, M.D. 301-796-0700 WO 22/Rm. 6312
Associate Director, Rare Disease ProgramAnne Pariser, MD. 301-796-0698 WO 22/Rm. 6474
Associate Director, Biosimilars ProgramLeah Christl, PhD. 301-796-0868 WO 22/Rm. 6468
Associate Director, Learning and Career DevelopmentSusanne Walker 301-796-5229 WO 22/Rm. 6419
Associate Director, Safety Policy and Research
Mwango Kashoki, MD. 301-796-1238 WO 22/Rm. 6310
OFFICE OF DRUG EVALUATION I (ODEI)
DirectorRobert J. Temple, M.D. (Acting) 301-796-2270 WO 22/Rm. 4212
AssistantAprile Blount 301-796-2270 WO 22/Rm. 4217
Deputy DirectorDr. Ellis Unger 301-796-2270 WO 22/Rm. 4208
Associate Director for Regulatory AffairsColleen LoCicero 301-796-2270 WO 22/Rm. 4216
Management OfficerAndrea Ferentinos 301-796-2270 WO 22/Rm. 4204
Division of Cardiovascular Renal Products (DCRP)
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DirectorNorman Stockbridge, M.D., Ph.D. 301-796-2240 WO 22/Rm. 4168
Deputy DirectorStephen Grant, M.D. 301-796-2240 WO 22/Rm. 4170
Supervisory Project ManagerEdward Fromm 301-796-2240 WO 22/Rm. 4162
Division of Neurology Products (DNP)
DirectorRussell G. Katz, M.D. 301-796-2250 WO 22/Rm. 4332
Deputy DirectorEric Bastings, M.D. 301-796-2250 WO 22/Rm. 4330
Supervisory Project ManagerRobbin Nighswander, R.Ph. 301-796-2250 WO 22/Rm. 4200
Jacqueline Ware, R.Ph. 301-769-2250 WO 22/Rm. 4346
Division of Psychiatry Products (DPP)
DirectorThomas Laughren, M.D. 301-796-2260 WO 22/Rm. 4114
Deputy Director
Mitchell Mathis, M.D. 301-796-2260 WO 22/Rm. 4112
Supervisory Project ManagersSteven Hardeman, R.Ph. 301-796-2260 WO 22/Rm. 4390Paul David, R.Ph. 301-796-2260 WO 22/Rm. 4100
OFFICE OF DRUG EVALUATION II (ODEII)
DirectorCurtis Rosebraugh, M. D. 301-796-2310 WO 22/Rm. 3214
SecretaryVelma Cunningham 301-796-2310 WO 22/Rm. 3221
Deputy DirectorVacant
Associate Director for Regulatory AffairsLeah Ripper 301-796-1282 WO 22/Rm. 3218
Management Officer
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Thomas Cunningham 301-796-1196 WO 22/Rm. 3208
Division of Metabolism and Endocrinology Products (DMEP)
DirectorMary Parks, M.D. 301-796-2290 WO 22/Rm. 3362
Deputy Director
Eric Colman, M.D. 301-796-1190 WO 22/Rm. 3360
Supervisory Project ManagersEnid M. Galliers 301-796-1211 WO 22/Rm. 3356Lina Aljuburi 301-796-1168 WO 22/Rm. 3366
Division of Pulmonary and Allergy Products (DPAP)
DirectorBadrul Chowdhury, M.D. 301-796-2300 WO 22/Rm. 3316
Deputy DirectorLydia Gilbert-McClain, M.D. 301-796-2300 WO 22/Rm. 3310
Supervisory Project ManagerSandra L. Barnes 301-796-1174 WO 22/Rm. 3306
Division of Analgesics, Anesthetics, and Rheumatology Products (DAARP)
DirectorBob A. Rappaport, M.D. 301-796-2280 WO 22/Rm. 3168
Deputy DirectorSharon Hertz, M.D. 301-796-2280 WO 22/Rm. 3170
Deputy DirectorRigoberto Roca, M.D. 301-796-2280 WO 22/Rm. 3136
Supervisory Project ManagersParinda Jani 301-796-1232 WO 22/Rm. 3166
Sara Stradley 301-796-1298 WO 22/Rm. 3162
OFFICE OF DRUG EVALUATION III (ODEIII)
DirectorJulie Beitz, M.D. 301-796-2100 WO 22/Rm. 5214
Program Support SpecialistDiane Thomas 301-796-0220 WO 22/Rm. 5221
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Deputy DirectorVacant
Associate Director for Regulatory AffairsMaria Walsh 301-796-2100 WO 22/Rm. 5218
Management OfficerAntoinette Mason 301-796-0954 WO 22/Rm. 5206
Division of Reproductive and Urologic Products (DRUP)
DirectorScott Monroe, M.D. 301-796-2130 WO 22/Rm. 5380
Deputy DirectorGeorge Benson, M.D. 301-796-2130 WO 22/Rm. 5346
Supervisory Project Managers
Margaret Kober 301-796-2130 WO 22/Rm. 5376Jennifer Mercier 301-796-2130 WO 22/Rm. 5358
Division of Gastroenterology Products (DGP)
DirectorDonna Griebel, M.D. 301-796-2120 WO 22/Rm. 5112
Deputy DirectorAndrew Mulberg 301-796-2120 WO 22/Rm. 5114
Supervisory Project ManagersRichard Wes Ishihara 301-796-2120 WO 22/Rm. 5118Brian Strongin 301-796-2120 WO 22/Rm. 5116
Division of Dermatology and Dental Products (DDDP)
DirectorSusan Walker, M.D. 301-796-2110 WO 22/Rm. 5168
Deputy DirectorStanka Kukich, M.D. 301-796-2110 WO 22/Rm. 5170
Supervisory Project ManagerBarbara Jean Gould 301-796-2110 WO 22/Rm. 5166
OFFICE OF ANTIMICROBIAL PRODUCTS (OAP)
DirectorEdward Cox, M.D., M.P.H. 301-796-1300 WO 22/Rm. 6212
Deputy Director
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John J. Farley, M.D., M.P.H. 301-796-1300 WO 22/Rm. 6208
Associate Director for Regulatory AffairsDavid Roeder 301-796-0799 WO 22/Rm. 6216
Management OfficerDana Schuhly 301-796-0806 WO 22/Rm. 6242
Division of Anti-Infective Products (DAIP)
DirectorJohn Farley, M.D., M.P.H. 301-796-1300 WO 22/Rm. 6208
Deputy DirectorKatherine Laessig, M.D. 301-796-0746 WO 22/Rm. 6380
Supervisory Project ManagersFrances LeSane 301-796-0747 WO 22/Rm. 6112
Maureen Dillon-Parker 301-796-0706 WO 22/Rm. 6134
Division of Anti-Viral Products (DAVP)
DirectorDebra Birnkrant, M.D. 301-796-0682 WO 22/Rm. 6332
Deputy DirectorJeffrey Murray, M.D., MPH 301-796-0770 WO 22/Rm. 6360
Supervisory Project Managers
Victoria Tyson 301-796-0827 WO 22/Rm. 6330Karen Winestock 301-796-0834 WO 22/Rm. 6322
Division Transplant and Ophthalmology Products (DTOP)
DirectorRenata Albrecht, M.D. 301-796-0664 WO 22/Rm. 6168
Deputy DirectorWiley A. Chambers, M.D. 301-796-0690 WO 22/Rm. 6336
Supervisory Project ManagerDiana Willard 301-796-0833 WO 22/Rm. 6114
Supervisory Project ManagerJudit Milstein 301-796-0763 WO 22/Rm. 6170
OFFICE OF DRUG EVALUATION IV (ODEIV)
DirectorCharles J. Ganley, M.D. 301-796-0895 WO 22/Rm. 5304
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SecretaryNorma Jiggetts 301-796-0924 WO 22/Rm. 5301
Deputy DirectorShaw T. Chen, M.D. 301-796-1054 WO 22/Rm. 5306
Associate Director for Regulatory AffairsVacant
Associate DirectorSusan Johnson, Pharm.D., Ph.D. 301-796-0925 WO 22/Rm. 5312
Management OfficerMerla Rae Matheny 301-796-0955 WO 22/Rm. 5314
Division of Nonprescription Clinical Evaluation (DNCE)
Director
Andrea Leonard-Segal, M.D. 301-796-0940 WO 22/Rm. 5474
Deputy DirectorJoel Schiffenbauer, M.D. 301-796-1288 WO 22/Rm. 5478
Program SpecialistPamela Hampton (Acting) 301-796-0904 WO 22/Rm. 5303
Division of Nonprescription Regulation Development (DNRD)
Director
M. Scott Furness, Ph.D. 301-796-0893 WO 22/Rm. 6474
Deputy DirectorDebbie Lumpkins 301-796-0947 WO 22/Rm. 5412
Program Specialist (Acting)Merla Rae Matheny 301-796-0955 WO 22/Rm. 5314
Division of Medical Imaging Products (DMIP)
DirectorRafel (Dwaine) Rieves, M.D. 301-796-2050 WO 22/Rm. 2348
SecretaryVacant
Deputy DirectorLibero Marzella, M.D. 301-796-1414 WO 22/Rm. 2346
Supervisory SCOKyong Kang 301-796-1970 WO 22/Rm. 2352
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Program SpecialistCrystal Coulter 301-796-1347 WO 22/Rm. 5425
OFFICE OF HEMATOLOGY AND ONCOLOGY PRODUCTS (OHOP)
Director Richard Pazdur, M.D. 301-796-2340 WO 22/Rm. 2212
Project SpecialistBertha Mejia 301-796-2340 WO 22/Rm. 2221
Deputy DirectorVacant 301-796-2340 WO 22/Rm. 2208
Associate Director for Regulatory AffairsTamy Kim (Acting) 301-796-2340 WO 22/Rm. 2200
Associate Director for Regulatory Science
Anthony Murgo, M.D. 301-796-2340 WO 22/Rm. 2208
Management OfficerKrista Yazdani 301-796-1029 WO 22/Rm. 2215
Division of Oncology Products (DOP 1)
DirectorRobert Justice, MD. 301-796-2330 WO 22/Rm. 2112
Secretary
Temitayo Lewis 301-796-2330 WO22/Rm. 2125
Deputy DirectorAmna Ibrahim, MD. 301-796-2330 WO 22/Rm. 2114
Supervisory CSOFrank Cross 301-796-2330 WO 22/Rm. 2110Alice Kacuba 301-796-2330 WO 22/Rm. 2104
Division of Oncology Products (DOP 2)
DirectorPatricia Keegan, MD. 301-796-2320 WO 22/Rm. 2320
SecretaryBarry Littleton 301-796-2320 WO 22/Rm. 2325
Deputy DirectorJoseph Gootenberg, MD. 301-796-2320 WO 22/Rm. 2312
Supervisory CSO
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Karen Jones 301-796-2320 WO 22/Rm. 2306
Division of Hematology Products (DHP)
DirectorAnn Farrell, M.D. 301-796-2330 WO 22/Rm. 2114
Secretary
Vacant
Deputy DirectorEdvardas Kaminskas, M.D. (Acting) 301-796-1383 WO 22/Rm. 2181
Supervisory CSOJanet Jamison 301-796-2313 WO 22/Rm. 2116
Division of Hematology Oncology Toxicology Products (DHOT)
Director
John Leighton (Acting) 301-796-2330 WO 22/Rm. 2204
SecretaryVacant
Deputy DirectorVacant
OFFICE OF SURVEILLANCE AND EPIDEMIOLOGY (OSE)
Director
Gerald Dal Pan, M.D., M.H.S. (Acting) 301-796-2380 WO 22/Rm. 4304
Program Support SpecialistBarbara M. McCary 301-796-2000 WO 22/Rm. 4303
Deputy DirectorHenry Francis, M.D. (Acting) 301-796-2380 WO 22/Rm. 4300
Supervisory Senior Management OfficerAmy Garvin 301-796-3413 WO 22/Rm. 4326
Outreach
Staff DirectorCheryl Campbell 301-796-0723 WO 22/Rm. 4308
Project Management Staff (PMS)
Staff DirectorSammie Beam (Acting) 301-796-2380 WO 22/Rm. 4480
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Office of Pharmacovigilance & Epidemiology (OPE)
DirectorGerald Dal Pan, M.D., M.H.S 301-796-2380 WO 22/Rm. 4304
Deputy DirectorHenry Frances, M.D. 301-796-2380 WO 22/Rm. 4300
Division of Pharmacovigilance I (DPV I)
DirectorLinda Scarazzini 301-796-2350 WO 22/Rm. 3478
Deputy DirectorVacant
Division of Pharmacovigilance II (DPV II)
DirectorVacant
Deputy DirectorBindi Nikhar, M.D. 301-796-2350 WO 22/Rm. 3418
Division of Epidemiology (DEPI)
DirectorSolomon Iyasu, M.D., M.P.H. 301-796-2370 WO 22/Rm. 2472
Deputy DirectorTarek Hammad, MD. 301-796-2370 WO 22/Rm. 2414
Division of Epidemiology II (DEPI II)
DirectorJudy Staffa, Ph.D. 301-796-2379 WO 22/Rm. 2474
Deputy DirectorLaura Governale 301-796-2370 WO 22/Rm. 2404
Office of Medication Error Prevention and Risk Management (OMEPRM)
DirectorVacant
Deputy DirectorVacant
Division of Risk Management (DRISK)
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DirectorClaudia Karwoski, Pharm. D. 301-796-5400 WO 22/Rm. 2418
Deputy DirectorMary Willy, Pharm. D. (Acting) 301-796-5400 WO 22/Rm. 2416
Division of Medication Errors Prevention and Analysis (DMEPA)
DirectorCarol Holquist, R.Ph. 301-796-2360 WO 22/Rm. 4416
Deputy DirectorVacant
OFFICE OF TRANSLATIONAL SCIENCES (OTS)
DirectorShaAvhree Buckman, M.D., Ph.D., F.A.A.P. 301-796-1721 WO 21/Rm. 4554
Program Support SpecialistKiesha Houston 301-796-2600 WO21/Rm. 4526
Deputy DirectorSusan McCune (Acting) 301-796-1709 WO 21/Rm. 4554
Supervisory Senior Management OfficerRaya S. McCree 301-796-1708 WO 21/Rm. 4512
Associate Director for Regulatory AffairsRubynell Jordan, BSN, MPA 301-796-3453 WO 22/Rm. 4528
Research CoordinatorCAPT Frances T. Gipson 301-796-0166 WO 21/Rm. 4542
Associate Director for ScienceJan Johannessen 301-796-2600 WO 21/Rm. 4546
OFFICE OF BIOSTATISTICS (OB)
DirectorRobert O’Neill, Ph.D. 301-796-1700 WO 21/Rm. 3554
Program Support SpecialistShereese Johnson (Acting) 301-796-1314 WO 21/Rm. 3547
Deputy DirectorEdward Nevius, Ph.D. 301-796-1263 WO 21/Rm. 3550
Associate DirectorSue Jane Wang, Ph.D. 301-796-0831 WO 21/Rm. 3526
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Associate Director for Statistical Science & PolicyRam Tiwari 301-796-4084 WO 21/Rm. 3524
Management OfficerLisa Gilmer 301-796-1768 WO 21/Rm. 4517
Division of Biometrics I (DBI)
DirectorJames Hung, Ph.D. 301-796-1092 WO 21/Rm. 4616
Deputy DirectorKooros Mahjoob, Ph.D. 301-796-1115 WO 21/Rm. 4614
Division of Biometrics II (DBII)
DirectorThomas Permutt, Ph.D. 301-796-1271 WO 21/Rm. 3614
Deputy DirectorJon Sahlroot 301-796-1286 WO 21Rm. 3612
Division of Biometrics III (DBIII)
DirectorStephen Wilson, Ph.D. 301-796-0579 WO 21/Rm. 3630
Division of Biometrics IV (DBIV)
Director
Mohammad Huque, Ph.D. 301-796-1800 WO 21/Rm. 3510
Deputy DirectorDaphne Lin, Ph.D. 301-796-0751 WO 21Rm. 3508
Division of Biometrics V (DBV)
DirectorAloka G. Chakravarty, Ph.D. 301-796-1655 WO 21/Rm. 3514
Deputy Director
Rajeshwari Sridhara 301-796-1759 WO 21/Rm. 3512
Division of Biometrics VI (DBVI)
DirectorStella Machado, Ph.D. 301-796-0949 WO 21/Rm. 4630
Deputy DirectorYi Tsong 301-796-1013 WO 21/Rm. 4628
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OFFICE OF CLINICAL PHARMACOLOGY (OCP)
Director Lawrence J. Lesko, Ph.D. 301-796-1565 WO 51/Rm. 3178
Program Support SpecialistKaren Graves 301-796-5008 WO 51/Rm. 3177
Deputy DirectorShiew-Mei Huang, Ph.D. 301-796-1541 WO 51/Rm. 3188
Associate Director of GenomicsIssam Zineh, Pharm.D. 301-796-4756 WO 51/Rm. 3182
Pharmacometrics StaffJogarao Gobburu, Ph.D. 301-796-1589 WO 51/Rm. 3186
Management OfficerMalcom Dennis 301-796-4107 WO 21/Rm. 4508
Division of Clinical Pharmacology I (DCPI)
DirectorMehul Mehta, Ph.D. 301-796-1573 WO 51/Rm. 2178
Deputy DirectorRamana S. Uppoor 301-796-1619 WO 51/Rm. 2182
Division of Clinical Pharmacology II (DCPII)
DirectorChandra Sahajwalla 301-796-1599 WO 51/Rm. 4550
Deputy DirectorSuresh Doddapaneni 301-796-1526 WO 51/Rm. 3136
Division of Clinical Pharmacology III (DCPIII)
DirectorDennis Bashaw, Ph.D. 301-796-1502 WO 51/Rm. 3134
Deputy DirectorHae Young Ahn 301-796-1494 WO 51/Rm. 3132
Division of Clinical Pharmacology IV (DCPIV)
DirectorJohn A. Lazor, Pharm.D. 301-796-1559 WO 51/Rm. 2134
Deputy DirectorKellie Reynolds 301-796-1594 WO 51/Rm.2142
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Division of Clinical Pharmacology V (DCPV)
DirectorAtik Rahman, Ph.D. 301-796-1591 WO 51/Rm. 2188
Deputy DirectorBrian Booth 301-796-1508 WO 51/Rm. 2186
OFFICE OF MEDICAL POLICY (OMP)
DirectorRachel E. Sherman, M.D. 301-796-2500 WO 51/Rm. 6338
AssistantLaura Myers 301-796-2500 WO 51/Rm. 6337
Deputy DirectorKathleen Uhl, M.D. 301-796-2500 WO 51/Rm. 6342
Associate Director for Regulatory AffairsJanet Norden 301-796-2500 WO 51/Rm. 6324
Senior Management OfficerTammy Russell 301-796-2500 WO 51/Rm. 6332
Office of Prescription Drug Promotion
DirectorThomas W. Abrams, RPh, MBA 301-796-1200 WO 51/Rm. 3264
Deputy DirectorVacant
Division of Direct –of-Consumer Promotion
DirectorVacant
Deputy DirectorVacant
Division of Professional Promotion
DirectorVacant
Deputy DirectorVacant
Office of Medial Policy Initiative
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DirectorCMDR Denise M. Hinton 301-796-1090 WO 51/Rm. 6348
Deputy DirectorVacant
Associate Director for Regulatory Affairs
Melissa Robb 301-796-5227 WO 51/Rm. 6360
Division of Medical Policy Development
DirectorPaula McKeever 301-796-8499 WO 51/Rm. 6358
Deputy DirectorVacant
Division of Medical Policy Programs
DirectorCMDR Richardae Araojo 301-796-1152 WO 51/Rm. 2218
Deputy DirectorVacant
OFFICE OF PLANNING & INFORMATICS (OPI)
Director
Theresa Mullin, Ph.D. 301-796-3800 WO 51/Rm. 1178
Deputy DirectorMary Ann Slack 301-796-0603 WO 51/Rm. 1188
Executive AssistantAngela Kwon 301-796-4957 WO51/Rm. 1183
Supervisory Senior Management OfficerMaria Andrews 301-796-2273 WO 51/Rm. 1184
Office of Planning & Analysis (OPA)
DirectorTheresa Mullin, Ph.D. (Acting) 301-796-3800 WO51/Rm. 1178
Management OfficerKathleen Tchoulakian 301-796-0570 WO 51/Rm. 1195
Analysis Staff (AS)
Staff Director
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Marta Wosinska, Ph.D. 301-796-3673 WO 51/Rm. 1186
Planning & Evaluation Staff (PES)
Staff DirectorSunanda Bahl 301-796-3584 WO 51/Rm. 1162
Office of Business Informatics (OBI)
DirectorHilmar Hamann, PhD. 301-796-1000 WO 22/Rm. 1124
Deputy DirectorGary Gensinger 301-796-0589 WO 22/Rm. 1112
Administrative AssistantJulie Quinonez 301-796-0282 WO 22/Rm. 1135
Management OfficerDenise Townsend 301-796-2112 WO 22/Rm. 1122
Computations Science Center Support Team
Technical ArchitectBinh Ta 301-796-4010 WO 22/Rm. 1128
Division of Project Development (DPD)
Division Director
Linda Sigg 301-796-0625 WO 22/Rm. 1114
Business Informatics Collaboration Team (BICT)William Taylor 301-796-0628 WO 22/Rm. 1175
Business Analysis Requirement Team (BART)Amy Gomez 301-796-0322 WO 22/Rm. 1123
Division of Business Analysis & Reporting (DBAR)
Division Director
Yashika Rahaman 301-796-3843 WO 22/Rm. 1110
Reports Management Team (RMT)Michael Cu 301-796-0582 WO 22/Rm. 1237
Data Retrieval and Analysis Team (DRAT)Nancy Maizel 301-796-0607 WO 22/Rm. 1209
Division of Regulatory Review Support (DRRS)
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Division DirectorMark Gray 301-796-2081 WO 22/Rm. 1132
eSubmission Support Team (eSST)Virginia Hussong 301-796-1016 WO 22/Rm. 1161
eReview Support Team (eRST)Samantha Gordon 301-796-4894 WO22/Rm. 1219
Division of Records Management (DRM)
Division DirectorGary Gensinger (Acting) 301-796-0589 WO 22/Rm. 1112
Records Management Team (RMT)Franklin Stephenson 301-796-3872 WO 22/Rm. 1189
Document Room Management Team (DRMT)Mia Prather 301-796-0618 WO 22/Rm. 1133
OFFICE OF COMMUNICATIONS (OCOMM)
DirectorJulie Zawisza 301-796-3700 Hillandale/Rm. 1126
Program Support SpecialistBrenda Adams 301-796-2015 Hillandale/Rm. 1124
Deputy DirectorKimberly Rawlings 301-796-3818 Hillandale/Rm. 1146
Management OfficerKelly Phelan 301-796-3176 Hillandale/Rm. 1144
Division of Training and Development (DTD) Moved to OEP
DirectorJanice Newcomb 301-796-3178 WO 51/Rm. 2358
Deputy DirectorVirginia Giroux 301-796-3179 WO 51/Rm. 2362
Division of Public Affairs (DPA)
DirectorAnthony E. Sims (Acting) 301-796-3121 Hillandale/ Rm. 4170
Project Specialist
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Paul G Neff 301-796-3123 Hillandale/Rm. 4168
Deputy DirectorAnthony E. Sims 301-796-3126 Hillandale/Rm. 4170
Division of Drug Information (DDI)
Director
Barry Poole 301-796-3145 Hillandale/Rm. 4130
Deputy DirectorMary Kremzner 301-796-3144 Hillandale/Rm. 4150
Division of Information Services (DIS)
DirectorPaul Buckman 301-796-3135 Hillandale/Rm. 1106
Deputy Director
Sally Winthrop 301-796-3135 Hillandale/Rm. 1122
OFFICE OF COMPLIANCE (OC) DirectorIlisa Bernstein, PharmD., JD. (Acting) 301-796-4723 WO 51/Rm. 5270
Executive AssistantsMarlene Sue Ling 301-796-3361 WO 51/Rm. 5269William Harris 301-796-2821 WO 51/Rm. 5271Paula Simmons 301-796-6229 WO 51/Rm. 5271
Deputy Director for Program OperationsJennifer Devine, JD. (Acting) 301-796-3363 WO 51/Rm. 5266
Deputy Director for Policy & Analysis Douglas Stearn, Esq. 301-796-3100 WO 51/Rm 5276
Associate Director of Scientific and Medical AffairsVacant
Associate Director for Risk Science, Intelligence & Prioritizing
H. Gregg Claycamp, M.S., Ph.D. (Acting) 301-796-3130 WO 51/Rm. 4266 Associate Director of Organizational StrategyKristi Hampton-Thurston (Acting) 301-796-3238 WO 51/Rm. 5276
Senior AdvisorVacant
Associate Director for Business AdministrationCollin Figueroa 301-796-5802 WO 51/Rm 1142
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Lead Management OfficerKaren Kirchberg 301-796-3233 WO 51/Rm. 4274
Contract SpecialistJoan Ginetis 301-796-4624 WO 51/Rm. 5250 Regulatory Counsels Meredith Francis, Esq. 301-796-3476 WO 51/Rm. 5258
Harry Schwirck, Esq. 301-796-4271 WO 51/Rm. 5286Ann Metayer, Esq. 301-796-3324 WO 51/Rm. 5212
Senior Communications AdvisorJudy Leon 301-796-4624 WO 51/Rm. 5250
Project Management Officers George Smith 301-796-3205 WO 51/Rm. 5284Milinda Soukup 301-796-1444 WO 51/Rm. 4320Brenda Woods-Francis 301-796-3647 WO 51/Rm. 5281
Executive Communications TeamKim Brown 301-796-4292 WO 51/Rm. 5208Margaret Cole 301-796-3966 WO 51/Rm. 5206
Senior Advisor for Regulatory ScienceVacant
Office of Unapproved Drugs and Labeling Compliance (OUDLC)
DirectorKathleen Anderson, PharmD. (Acting) 301-796-3309 WO 51/Rm. 5182
Associate Director for Policy and CommunicationGail Bormel (Acting) 301-796-3263 WO 51/Rm. 5186
Associate Director for Program Management and Organizational StrategyAkilah Green (Acting) 301-796-1219 WO 51/Rm. 5166
Associate Director for Risk Science, Intelligence and PrioritizationMeghan Murphy (Acting) 301-796-3307 WO 51/Rm. 5178
Senior Medical AdvisorCharlie Lee 301-796-1244 WO 51/Rm. 5184
Senior AdvisorBob Heller (Acting) 301-796-3353 WO 51/Rm. 5246
Project Management OfficersAlisea Crowley 301-796-1144 WO 51/Rm. 5196
Division of Non-Prescription Drugs and Health FraudElizabeth Miller 301-796-3342 WO 51/Rm. 5176
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Over the Counter Drugs BranchAnuj Shah (Acting) 301-796-2246 WO51/Rm. 5104
Health Fraud and Consumer Outreach BranchVacant
Health Fraud and Consumer Outreach Team
Brad Pace (Acting Team Leader) 301-796-3538 WO 51/Rm. 5171
Division of Prescription DrugsJudy McMeekin (Acting) 301-796-3344 WO 51/Rm. 5237
Prescription Drugs BranchSakineh Walther (Acting) 301-796-3349 WO 51/Rm. 5242
Marketed Unapproved Drugs Enforcement TeamTia Harper-Velazquez (Acting) 301-796-3301 WO 51/Rm. 5171
Marketed Unapproved Drugs-Regulatory Status & Labeling TeamKim Simmons (Acting) 301-796-3684 WO 51/Rm. 4212
Compounding and Pharmacy Practices BranchVacant
Compounding and Pharmacy Practice TeamIan Deveau (Acting) 301-796-5061 WO 51/Rm. 5198
Office of manufacturing and Product Quality (OMPQ)
Director Steve Lynn (Acting) 301-796-3315 WO 51/Rm. 4360 Deputy Director Michael Smedley (Acting) 301-796-3273 WO 51/Rm. 4348
Associate Director for Program Management & Organizational StrategyKennerly K. Chapman 301-796-3271 WO 51/Rm. 4346
Associate Director for Risk Science Intelligence & PrioritizationRick Friedman (Acting) 301-796-3268 WO 51/Rm. 4342
Associate Director for Policy & CommunicationBrian Hasselbalch (Acting) 301-796-3279 WO 51/Rm. 4364
Associate Director for Drug Quality AssuranceVacant
Senior AdvisorHelen Saccone (Acting) 301-796-3647 WO 51/Rm. 5283
Project Management Officers (co-located)
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Kennerly Chapman 301-796-3271 WO 51/Rm. 4346 Helen Saccone, PharmD. 301-796-4758 WO 51/Rm. 4228Keith Olin, PharmD. 301-796-0962 WO 51/Rm. 4355
Regulatory CounselH. Joy Sharp 301-796-3647 WO 51/Rm. 4326
Division of Good Manufacturing Practice Assessment
DirectorBarry Rothman 301-796-3281 WO 51/m. 4372
New Drug Manufacturing Assessment BranchBranch ChiefDavud Doleski (Acting) 301-796-2627 WO 51/Rm. 4372
Generic Drug Manufacturing Assessment BranchBranch ChiefConcepcion Cruz (Acting) 301-796-3254 WO 51/Rm. 4316
Biotech Manufacturing Assessment BranchBranch ChiefPatricia Hughes (Acting) 301-796-3189 WO 51/Rm. 4328
Division of Domestic Drug QualityDirectorTeddi Lopez (Acting) 301-796-3255 WO 51/Rm. 4368
Domestic Compliance Branch 1
Branch ChiefVacant
Domestic Compliance Branch 2Branch ChiefDavid Jaworski (Acting) 301-796-3192 WO 51/Rm. 4242
Division of International Drug ComplianceDirectorCarmelo Motta (Acting) 301-796-3367 WO 51/Rm. 4240
International Compliance Branch 1Branch ChiefRosa Motto (Acting) 301-796-3283 WO 51/Rm. 4368
International Compliance Branch 2Branch ChiefVacant
Division of Policy, Collaboration & Data Operations
Director
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Vacant
Regulatory Policy & Collaboration BranchBranch ChiefGrace McNally (Acting) 301-796-3286 WO 51/Rm. 4374
Drug Surveillance & Data Reporting BranchBranch Chief
Elise Murphy (Acting) 301-796-7565 WO 51/Rm. 4272
Drug Quality Reporting SystemDirect Line 301-796-3140
Drug Registration and Listing System (DRLS) 301-796-3130
Office of Scientific Investigations (OSI)
DirectorLeslie Ball, M.D. (Acting) 301-796-3150 WO 51/Rm. 5342
Deputy DirectorThomas Moreno (Acting) 301-796-2247 WO 51/Rm. 5278
Associate Director for Risk Science, Intelligence & PrioritizingAnn Meeker- O’Connell (Acting) 301-796-7615 WO 51/Rm. 5339
Associate Director for Policy and CommunicationKarena Cooper (Acting) 301-796-1612 WO 51/Rm. 5252
Associate Director for Program Management and Organizational StrategyTanya Clayton (Acting) 301-796-0871 WO 51/Rm. 2224
Division of Safety ComplianceKevin Prohaska (Acting) 301-796-3707 WO 51/Rm. 5356
Post Market Safety BranchSuzanne Barone (Acting) 301-796-3224 WO 51/Rm. 4258
Human Subject Protection Branch
Pay McNeilly (Acting) 301-796-2947 WO 51/Rm. 2266
Div. of Good Clinical Practice ComplianceTejashri Purohit-Sheth, M.D. (Acting) 301-796-3402 WO 51/Rm. 5358
Good Clinical Practice Branch Enforcement BranchConstance Lewin, MD. (Acting) 301-796-3397 WO 51/Rm. 5354
Good Clinical Practice Assessment BranchJean Mulinde (Acting) 301-796-0768 WO 51/Rm. 5318
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Div. of Good Laboratory Practice and Bioequivalence InvestigationsJoseph Salewski (Acting) 301-796-3395 WO 51/Rm 5348
Associate Director for Bioequivalence & Good Laboratory PracticeCT Viswanathan, PhD. 301-796-3394 WO 51/Rm. 5346
Bioequivalence BranchSam Haidar 301-796-4777 WO 51/Rm. 5330
Good Laboratory Practice TeamCharles Bonapace (Acting) 301-796-1507 WO 51/Rm. 5228
OFFICE OF COUNTER-TERRORISM AND EMERGENCY COORDINATION (OCTEC)
DirectorRosemary Roberts, M.D. 301-796-2210 WO 51/Rm. 3342
Deputy DirectorBrad Leissa, M.D. 301-796-2210 WO 51/Rm. 3348
Management AnalystPilar Martinez 301-796-1756 WO 51/Rm. 3346
Program Support SpecialistVacant
Assoc. Dir. Emergency Risk CommunicationThomas J. Christle 301-796-2057 WO 51/Rm. 3358
Associate Director of Emergency Coordination
Susan McDermott, M.D. 301-796-1121 WO 51/Rm. 3362
Associate Director for Regulatory AffairsJoanne Holmes, R.Ph. 301-796-1681 WO 51/Rm. 3352
Management OfficerKaren D. Smith 301-796-1756 WO 51/Rm. 3334