CENTER FOR BIOLOGICS EVALUATION AND RESEARCH
OFFICE OF THE CENTER DIRECTOR
DIRECTOR JESSE L. GOODMAN, M.D., M.P.H. HFM-1 N29B 5NN02 301-827-0372 fax 301-827-0440 5NN01 301-827-0372
Deputy Director
KAREN MIDTHUN, M.D.
HFM-6
N29B
Medical Director for Emerging & Pandemic Threat Preparedness Senior Scientist and Point of Contact for Emerging & Pandemic Threat Preparedness Associate Director for Quality Assurance
(VACANT)
HFM-1
N29B
5NN01 301-827-0372
JEAN HU-PRIMMER
HFM-1
N29B
1NN14 301-827-6352 fax 301-594-6530 170 301-827-0379 fax 301-827-2920
SHERYL L. LARD-WHITEFORD, Ph.D.
HFM-4
WOC1
Associate Director for Policy
DIANE MALONEY, J.D.
HFM-10
N29B
5NN14 301-827-0372 fax 301-827-0440 550N 301-827-6210 fax 301-827-9434 301-827-0377 fax 301-827-0440 301-402-4996 fax 301-435-2231 301-827-0373 fax 301-827-9434 301-827-5940 fax 301-594-0149
Regulations and Policy Staff
STEPHEN M. RIPLEY (ACTING)
HFM-17
WOC1
Associate Director for Research
CAROLYN A. WILSON, Ph.D. (ACTING)
HFM-20
N29B
5N22
Core Facilities Team
NGA YEN NGUYEN, Ph.D.
HFM-23
N29
205
Associate Director for Review Management
ROBERT A. YETTER, Ph.D.
HFM-25
WOC1
550N
Document Control Center
JULES M. MEISLER
HFM-99
WOC1
200N
Senior Advisor for Chemistry & Manufacturing Controls
CHRISTOPHER C. JONECKIS, Ph.D.
HFM-1
N29B
1NN08 301-435-5681 fax 301-827-0440
1 02/08
Senior Advisor for International Affairs
JOAN WILMARTH BLAIR
HFM-30
N29B
5N14
301-827-0639 fax 301-827-0440
Senior Advisor for Counterterrorism/Medical Countermeasures Special Assistant to the Director for Human Subject Protection Emergency Response Coordinator Science Communications Advisor
CYNTHIA L. KELLEY, M.S.
HFM-6
N29B
1NN16 301-827-0636 fax 301-435-2246 1NN06 301-496-1864 fax 301-435-2246 1NN02 301-827-9807 5NN10 301-827-0372 fax 301-827-0440
RICHARD D. DIAMOND, M.D., M.P.A.
HFM-6
N29B
GEORGE R. GENTILE MARC KUSINITZ, Ph.D.
HFM-6 HFM-2
N29B N29B
2 02/08
OFFICE OF BIOSTATISTICS AND EPIDEMIOLOGY
DIRECTOR Deputy Director Associate Director for Risk Assessment Associate Director for Research Division of Biostatistics STEVEN A. ANDERSON, Ph.D. (ACTING) JAWAHAR TIWARI, Ph.D. (ACTING) MARK O. WALDERHAUG, Ph.D. M. MILES BRAUN, M.D., M.P.H. HENRY S. HSU, Ph.D., M.P.H. HFM-210 HFM-210 HFM-210 HFM-210 HFM-215 WOC1 WOC1 WOC1 WOC1 WOC1 200S 200S 200S 200S 200S 301-827-3034 fax 301-827-3529 301-827-3034 301-827-3034 301-827-3974 301-827-3977 fax 301-827-5218 301-827-3977 fax 301-827-5218 301-827-3977 301-827-3977
Associate Director for Regulatory Policy
JAWAHAR TIWARI, Ph.D.
HFM-219
WOC1
200S
Vaccine Evaluation Branch Therapeutics Evaluation Branch
A. DALE HORNE, Dr. P.H. GHANSHYAM GUPTA, Ph.D.
HFM-217 HFM-219
WOC1 WOC1
200S 200S
Division of Epidemiology
M. MILES BRAUN, M.D., M.P.H.
HFM-220
WOC1
200S
301-827-3974 fax 301-827-3529 301-827-3974 301-827-3974
Vaccine Safety Branch Therapeutics and Blood Safety Branch
ROBERT BALL, M.D., M.P.H., Sc.M. ROBERT P. WISE, M.D., M.P.H
HFM-222 HFM-224
WOC1 WOC1
200S 200S
3 02/08
OFFICE OF COMMUNICATION, TRAINING AND MANUFACTURERS ASSISTANCE
DIRECTOR
LORRIE H. McNEILL
HFM-40
RKWL
601
301-827-2000 fax 301-827-3843 301-827-2000
Deputy Director
JOANNE C. BINKLEY
HFM-40
RKWL
601
Division of Manufacturers Assistance and Training
LESLIE D. WHEELOCK
HFM-42
RKWL
601
301-827-2000 fax 301-827-3079 301-827-2000 301-827-2000
Career Development and Directed Training Branch Manufacturers Assistance & Technical Training Branch
LAURA L. STEWART ADRIENNE HORNATKO-MUNOZ
HFM-49 HFM-41
RKWL RKWL
601 601
Division of Disclosure and Oversight Management
JOANNE C. BINKLEY (ACTING)
HFM-44
RKWL
601
301-827-2000 fax 301-827-3843 301-827-2000 301-827-2000
Congressional and Oversight Branch Access Litigation & Freedom of Information Branch
SUSAN C. FRANTZ-BOHN BETH BROCKNER-RYAN
HFM-46 HFM-48
RKWL RKWL
601 601
Division of Communication and Consumer Affairs Executive Secretariat Team Communication Technology Branch Consumer Affairs Branch
DIANE BARTELL DIANE BARTELL (ACTING) KAREN A. GROOVER CHRISTOPHER T. MIDDENDORF
HFM-43 HFM-5 HFM-45 HFM-47
RKWL RKWL RKWL RKWL
601 601 601 601
301-827-2000 fax 301-827-3843 301-827-2000 fax 301-827-3843 301-827-2000 301-827-2000
4 02/08
OFFICE OF MANAGEMENT
DIRECTOR Deputy Director Regulatory Information Management Staff White Oak Planning Team JOSEPH A. BIVIANO JAMES M. SIGG ROGER D. EASTEP MAUREEN E. SHERIDAN HFM-100 HFM-100 HFM-110 HFM-118 RKWL RKWL RKWL RKWL 360 360 375 513 301-827-1320 fax 301-827-1438 301-827-1320 301-827-3503 fax 301-827-2875 301-827-0413 fax 301-827-3137 301-827-1400 fax 301-827-1441 301-827-1867 301-827-3502 fax 301-827-3137 301-827-1400 301-827-1400 301-827-1414 fax 301-827-1102 301-827-1414 301-827-1414 301-827-0314 fax 301-827-0294 301-827-1847 fax 301-402-2408
Division of Program Services Assistant Director for Safety Building Operations Staff Program Operations Branch Program Management Services Branch Division of Planning, Evaluation, & Budget Resource Management Branch Planning & Evaluation Branch Division of Scientific Advisors & Consultants Division of Veterinary Services
DAVID R. LEFFLER LARRY M. SOLOMON CATRINA M. POSLEY (ACTING) CYNTHIA A. HARTSMITH MARSHA C. WILLIAMS KAREN M. O’BRIEN CONNIE GIGANTI MARY PAT LEARY WILLIAM FREAS, Ph.D. PHILIP J. SNOY, D.V.M.
HFM-115 HFM-114 HFM-118 HFM-122 HFM-123 HFM-140 HFM-145 HFM-150 HFM-71 HFM-22
RKWL N29A RKWL RKWL RKWL RKWL RKWL RKWL RKW2 N29A
350 1C02 513 350 350 420 420 420 1113 1A17
5 02/08
OFFICE OF INFORMATION TECHNOLOGY
DIRECTOR
GINGER G. LEO
HFM-160
RKWL
400
301-827-1368 fax 301-827-3053 301-827-1368
Deputy Director
AMY EL NAGGAR
HFM-165
RKWL
400
Chief Technology Officer
MARCO S. VENIDA
HFM-160
RKWL
400
301-827-1368 fax 301-827-3053
Division of Information Operations
AMY EL NAGGAR
HFM-165
RKWL
400
301-827-1368 fax 301-827-3053
Division of Information Development
NADIA O. DAVEY
HFM-170
RKWL
400
301-827-1368 fax 301-827-3053
6 02/08
OFFICE OF BLOOD RESEARCH AND REVIEW
DIRECTOR
JAY S. EPSTEIN, M.D.
HFM-300
WOC1
400N
301-827-3518 fax 301-827-3533 301-827-3518 301-827-3518 301-827-3518 301-827-3518 301-827-3514 fax 301-827-2843 301-827-3518 301-827-3008 fax 301-480-7928 301-827-6569 301-827-3011 301-827-6681 301-594-6733
Deputy Director Associate Deputy Director Associate Director for Regulatory Affairs Associate Director for Research Associate Director for Policy and Communications & Chief, Policy and Publications Staff Special Assistant to the Director Division of Emerging & Transfusion Transmitted Diseases - I.O.D. Deputy Director Product Testing Staff Product Review Branch Laboratory of Bacterial, Parasitic, & Unconventional Agents Laboratory of Molecular Virology Laboratory of Hepatitis & Related Emerging Agents
JONATHAN C. GOLDSMITH, M.D. MARK J. WEINSTEIN, Ph.D. ALAN E. WILLIAMS, Ph.D. CHINTAMANI D. ATREYA, Ph.D. JENNIFER B. SCHARPF, M.P.H.
HFM-300 HFM-300 HFM-300 HFM-300 HFM-350
WOC1 WOC1 WOC1 WOC1 WOC1
400N 400N 400N 400N 400N
LINDA M. ALMS HIRA L. NAKHASI, Ph.D.
HFM-300 HFM-310
WOC1 N29
400N 222
PAUL A. MIED, Ph.D ROBIN M. BISWAS, M.D. ELLIOT P. COWAN, Ph.D. DAVID ASHER, M.D.
HFM-310 HFM-310 HFM-394 HFM-313
N29 N29 WOC1 NLRC
219 225 300S 236
INDIRA K. HEWLETT, Ph.D. GERARDO KAPLAN, Ph.D.
HFM-315 HFM-325
N29B N29
4NN16 301-827-0795 225 301-496-0338 fax 301-480-7928
7 02/08
OFFICE OF BLOOD RESEARCH AND REVIEW
Division of Hematology
BASIL GOLDING, M.D.
HFM-330
N29
326
301-496-4396 fax 301-402-2780 301-496-4396 301-827-9655 301-496-4833 301-827-3016 301-827-6112 301-827-3813
Deputy Director Laboratory of Cellular Hematology Laboratory of Hemostasis Laboratory of Plasma Derivatives Clinical Review Branch Laboratory of Biochemistry and Vascular Biology
SUSAN L. ABBONDANZO, M.D. JAROSLAV G. VOSTAL, M.D., Ph.D. TIMOTHY K. LEE, Ph.D. (ACTING) DOROTHY E. SCOTT, M.D. TOBY A. SILVERMAN, M.D. ABDU ALAYASH, Ph.D.
HFM-330 HFM-335 HFM-340 HFM-345 HFM-392 HFM-343
N29 N29 N29 N29 WOC1 N29
238 321 311 232 400N 112
Division of Blood Applications
ELIZABETH G. CALLAGHAN (ACTING)
HFM-370
WOC1
400N
301-827-3524 fax 301-827-3535 301-827-3524 301-827-3524 301-827-3524 301-827-3524
Deputy Director Blood and Plasma Branch Regulatory Project Management Branch Devices Review Branch
ELIZABETH G. CALLAGHAN LESLIE G. HOLNESS, M.D. JEFFREY M. ANDERSON SHERYL A. KOCHMAN
HFM-370 HFM-375 HFM-380 HFM-390
WOC1 WOC1 WOC1 WOC1
400N 400N 400N 400N
8 02/08
OFFICE OF VACCINES RESEARCH AND REVIEW
DIRECTOR NORMAN W. BAYLOR, Ph.D. HFM-400 N29B 1H16 301-827-0655 fax 301-827-0448 301-827-5105 301-827-0655 301-827-0655 301-827-0655 301-827-5105 fax 301-827-9781 301-827-5105 301-827-5407 301-594-6299 fax 301-480-9748 301-594-6241 301-594-6243 301-594-6242 301-827-3070 fax 301-827-3532 301-827-3070 301-827-3070 301-827-3070 301-827-3070
Deputy Director Associate Director for Science Associate Director for Management & Scientific Affairs Associate Director for Quality Assurance Associate Director for Regulatory Policy Special Assistant for Communication Program Operation Staff Division of Product Quality Product Quality Laboratory Staff Quality Assurance Staff Validation Staff Division of Vaccines & Related Products Applications Deputy Director Viral Vaccines Branch Bacterial Vaccines Branch Vaccine Clinical Trials Branch 02/08
FLORENCE HOUN, M.D. MICHAEL J. BRENNAN, Ph.D. ERIK A. HENCHAL, Ph.D. (VACANT) MARION F. GRUBER, Ph.D. MAUREEN A. HESS, M.P.H. LINDA H. SHONE WILLIAM M. McCORMICK, Ph.D. RAJESH K. GUPTA, Ph.D. CHRISTOPHER BASTEDO LOKESH BHATTACHARYYA, Ph.D. LORIS D. McVITTIE, Ph.D. (ACTING)
HFM-405 HFM-400 HFM-400 HFM-400 HFM-405 HFM-405 HFM-405 HFM-406 HFM-406 HFM-407 HFM-406 HFM-475
WOC1 N29B N29B N29B WOC1 WOC1 WOC1 NLRC NLRC NLRC NLRC WOC1
350N 1H16 1H16 1H16 360N 360N 352 2400 2401 2403 2400 300N
LEWIS K. SCHRAGER, M.D. (ACTING) LORIS D. McVITTIE, Ph.D. PAUL G. RICHMAN, Ph.D. DOUGLAS R. PRATT, M.D. 9
HFM-475 HFM-478 HFM-481 HFM-485
WOC1 WOC1 WOC1 WOC1
300N 300N 300N 300N
OFFICE OF VACCINES RESEARCH AND REVIEW
Division of Viral Products JERRY P. WEIR, Ph.D. HFM-445 N29A 1A21 301-827-1930 fax 301-496-1810 301-827-1930 301-827-1880 301-827-1886
Deputy Director Laboratory of Hepatitis Viruses Laboratory of Vector Borne Diseases Laboratory of Retroviruses Laboratory of DNA Viruses Lab. of Pediatric & Respiratory Viral Diseases Laboratory of Method Development Laboratory of Immunoregulation
PHILIP R. KRAUSE, M.D. STEPHEN M. FEINSTONE, M.D. LEWIS J. MARKOFF, M.D. HANA GOLDING, Ph.D. ANDREW M. LEWIS, M.D. JERRY P. WEIR, Ph.D. (ACTING) KONSTANTIN M. CHUMAKOV, Ph.D. IRA J. BERKOWER, M.D., Ph.D.
HFM-445 HFM-448 HFM-451 HFM-454 HFM-457 HFM-460 HFM-470 HFM-466
N29A N29A N29A N29B N29A N29A NLRC N29
1C16 1D14 1B17
4NN04 301-827-0784 1B06 1A21 B-128 523 301-827-0650 301-827-1970 301-594-3720 301-496-1870
Division of Bacterial, Parasitic & Allergenic Products
MILAN S. BLAKE, Ph.D. (ACTING)
HFM-410
N29
130
301-496-1014 fax 301-402-2776 301-496-1014 301-496-4575 301-496-1014 301-496-5978 301-402-3553 301-496-1893 301-435-5196
Deputy Director Laboratory of Immunobiochemistry Laboratory of Bacterial Polysaccharides
JAY E. SLATER, M.D. (ACTING) JAY E. SLATER, M.D. WILLIE F. VANN, Ph.D.
HFM-410 HFM-422 HFM-428 HFM-431 HFM-434 HFM-440 HFM-443
N29 N29 N29 N29 N29 N29 N29
130 203 130 502 124 420 419
Lab. of Mycobacterial Diseases & Cellular Immunology SHELDON L. MORRIS, Ph.D. Laboratory of Respiratory & Special Pathogens Lab. of Enteric & Sexually Transmitted Diseases Lab. of Methods Development & Quality Control DRUSILLA L. BURNS, Ph.D. DENNIS J. KOPECKO, Ph.D. (VACANT)
10 02/08
OFFICE OF COMPLIANCE AND BIOLOGICS QUALITY
DIRECTOR Deputy Director Special Assistant to the Director Associate Director for Policy Associate Director for Regulatory Policy Assistant to the Director for Labeling Policy and Medical Communication Assistant to the Director for Manufacturing and Policy Division of Case Management Advertising & Promotional Labeling Branch Biological Drug and Device Compliance Branch Blood and Tissue Compliance Branch Division of Inspections & Surveillance Bioresearch Monitoring Branch Program Surveillance Branch Program Inspection Branch MARY ANNE MALARKEY LESLIE KUX THOMAS J. ADAMS ANITA F. RICHARDSON JESSICA A. TAVE (VACANT) (VACANT) ROBERT A. SAUSVILLE ELE IBARRA-PRATT, R.N., B.S.N., M.P.H. DIANE S. ALEXANDER STEPHANY J. WESLEY GILLIAM B. CONLEY PATRICIA A. HOLOBAUGH JANET L. ISHIMOTO (VACANT) HFM-600 HFM-600 HFM-600 HFM-600 HFM-600 HFM-600 HFM-600 HFM-610 HFM-602 HFM-624 HFM-614 HFM-650 HFM-664 HFM-654 HFM-604 WOC1 WOC1 WOC1 WOC1 WOC1 WOC1 WOC1 WOC1 WOC1 WOC1 WOC1 WOC1 WOC1 WOC1 WOC1 400S 400S 400S 400S 400S 400S 400S 400S 400S 400S 400S 400S 400S 400S 400S 301-827-6190 fax 301-827-3381 301-827-6190 301-827-6190 301-827-6190 301-827-6190 301-827-6190 301-827-6190 301-827-6201 fax 301-594-0940 301-827-6201 301-827-6201 301-827-6201 301-827-6220 fax 301-827-6748 301-827-6220 301-827-6220 301-827-6220
11 02/08
OFFICE OF COMPLIANCE AND BIOLOGICS QUALITY
Division of Manufacturing and Product Quality Deputy Director Product Release Branch Manufacturing Review Branch I Manufacturing Review Branch II JOHN A. ELTERMANN, JR LAURIE P. NORWOOD JOSEPH QUANDER, III CAROLYN A. RENSHAW CHIANG SYIN, Ph.D. HFM-670 HFM-670 HFM-672 HFM-675 HFM-676 NLRC NLRC NLRC NLRC NLRC A-217 A-237 A-209 A-252 A-234 301-827-3031 fax 301-827-3536 301-827-3031 301-594-6517 301-827-3031 301-827-3031
12 02/08
OFFICE OF CELLULAR, TISSUE AND GENE THERAPIES
DIRECTOR Deputy Director Regulatory Management Staff Associate Director for Research Associate Director for Policy Division of Cellular and Gene Therapies Deputy Director Cell Therapies Branch Gene Therapies Branch Gene Transfer and Immunogenicity Branch Tumor Vaccines and Biotechnology Branch Cellular and Tissue Therapy Branch Division of Clinical Evaluation & Pharmacology/ Toxicology Clinical Evaluation Branch Pharmacology/Toxicology Branch Division of Human Tissues Human Tissue and Reproduction Branch CELIA M. WITTEN, M.D., Ph.D. STEPHANIE L. SIMEK, Ph.D. STEPHANIE L. SIMEK, Ph.D. (ACTING) SUZANNE L. EPSTEIN, Ph.D. RICHARD D. McFARLAND, M.D. RAJ K. PURI, M.D., Ph.D. KIMBERLY A. BENTON, Ph.D. KEITH M. WONNACOTT, Ph.D. DANIEL M. TAKEFMAN, Ph.D. RAJ K. PURI, M.D., Ph.D. (ACTING) RAJ K. PURI, M.D., Ph.D. (ACTING) STEVEN R. BAUER, Ph.D. (ACTING) ASHOK K. BATRA, M.D. PETER F. BROSS MERCEDES A. SERABIAN, M.S., DABT RUTH R. SOLOMON, M.D. MARTHA A. WELLS, M.P.H. HFM-700 HFM-700 HFM-705 HFM-700 HFM-700 HFM-710 HFM-720 HFM-715 HFM-720 HFM-725 HFM-735 HFM-740 HFM-750 HFM-755 HFM-760 HFM-770 HFM-775 WOC1 WOC1 WOC1 N29B WOC1 N29B WOC1 WOC1 WOC1 N29B N29B N29B WOC1 WOC1 WOC1 WOC1 WOC1 200N 200N 200N 301-827-6536 fax 301-827-9796 301-827-5102 301-827-6536
2NN06 301-827-0680 200N 301-827-6536
2NN10 301-827-0680 fax 301-827-0449 200N 200N 200N 301-827-5102 301-827-5102 301-827-5102
2NN04 301-827-0680 2NN10 301-827-0680 2NN20 301-827-0680 200N 200N 200N 200S 200S 301-827-6536 fax 301-827-9796 301-827-6536 301-827-6536 301-827-6107 fax 301-827-2844 301-827-6106
13 02/08