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CENTER FOR BIOLOGICS EVALUATION AND RESEARCH

Office of Information Director: Jesse L. Goodman, M.D., M.P.H. Office of Biostatistics and
Technology Deputy Director: Karen Midthun, M.D. Epidemiology
Ginger G. Leo Associate Director for Research: Kathryn M. Carbone, M.D. *Steven A. Anderson, Ph.D.
Associate Director for Policy: Diane Maloney, J.D.
Division of Information Associate Director for Quality Assurance: Sheryl L. Lard-Whiteford, Ph.D. Division of Biostatistics
Operations Associate Director for Review Management: Robert A. Yetter, Ph.D. Henry S. Hsu, Ph.D., M.P.H.
*Amy El Naggar Medical Dir. for Emerging & Pandemic Threat Preparedness: (Vacant)
Senior Advisor for International Affairs: Joan Wilmarth Blair
Division of Information Senior Advisor for Counterterrorism/Medical Countermeasures: Cynthia L. Kelley, M.S. Division of Epidemiology
Development
Senior Advisor for Chemistry and Manufacturing Controls: Christopher C. Joneckis, Ph.D. M. Miles Braun, M.D.,
*Nadia O. Davey M.P.H.

Office of Cellular, Tissue Office of Communication, Office of Blood Research Office of Vaccines Office of Compliance and Office of Management
and Gene Therapies Training and and Review Research and Review Biologics Quality
Joseph A. Biviano
Manufacturers Assistance Jay S. Epstein, M.D.
Celia M. Witten, M.D., Ph.D. Norman W. Baylor, Ph.D. Mary A. Malarkey
Lorrie H. McNeill

Division of Cellular and Division of Division of Emerging Division of Bacterial, Division of Case Division of Planning,
Gene Therapies Manufacturers Transfusion Transmitted Parasitic & Allergenic Management Evaluation, and Budget
Assistance and Training Diseases Products
Raj K. Puri, M.D., Ph.D. Robert A. Sausville Karen M. O'Brien
Leslie D. Wheelock Hira L. Nakhasi, Ph.D. Richard I. Walker, Ph.D.

Div. of Clinical Evaluation Division of Disclosure Division of Division of Viral Division of Inspections Division of Program
& Pharmacology/ and Oversight Hematology Products and Surveillance Services
Toxicology Management Basil Golding, M.D. Gilliam B. Conley
Jerry P. Weir, Ph.D. David R. Leffler
Ashok K. Batra, M.D. Joanne C. Binkley

Division of Human Division of Division of Blood Division of Vaccines & Division of Division of Scientific
Tissues Communication and Applications Related Products Manufacturing and Advisors & Consultants
Consumer Affairs Applications Product Quality William Freas, Ph.D.
Ruth R. Solomon, M.D. *Elizabeth G. Callaghan
*Lorrie H. McNeill *Paul G. Richman, M.D. John A. Eltermann, Jr.

Division of Product Division of Veterinary


Quality Services
William M. McCormick, Ph.D. Philip J. Snoy, D.V.M.

*Acting 10/07.1
Director
CENTER FOR Jesse L. Goodman, M.D., M.P.H.
Deputy Director
BIOLOGICS Karen Midthun, M.D.
EVALUATION Associate Director for Policy
Diane Maloney, J.D.
AND Associate Director for Quality Assurance
Sheryl L. Lard-Whiteford, Ph.D.
RESEARCH Associate Director for Research
Kathryn M. Carbone, M.D.
Associate Director for Review Management
Robert A. Yetter, Ph.D.
Senior Advisor for International Affairs
Joan Wilmarth Blair
Senior Advisor for Counterterrorism/Medical Countermeasures
Cynthia L. Kelley, M.S.
Senior Advisor for Chemistry and Manufacturing Controls
Christopher C. Joneckis, Ph.D.
Medical Advisor for Emerging & Pandemic Threat Preparedness
(Vacant)
Senior Scientist for Emerging & Pandemic Threat Preparedness
Jean L. Hu-Primmer, M.S.
Special Assistant to the Director for Human Subject Protection
Richard D. Diamond, M.D., M.P.A.

Office of Biostatistics and Office of Communication, Training Office of Office of


Epidemiology & Manufacturers Assistance Management Information Technology
*Steven A. Anderson, Ph.D. Lorrie H. McNeill Joseph A. Biviano Ginger G. Leo

Office of Blood Office of Vaccines Research and Office of Compliance and Office of Cellular, Tissue and
Research and Review Review Biologics Quality Gene Therapies
Jay S. Epstein, M.D. Norman W. Baylor, Ph.D. Mary Anne Malarkey Celia M. Witten, M.D., Ph.D.

*Acting 10/07.2
Director
Jesse L. Goodman, M.D., M.P.H.
CBER Deputy Director
IMMEDIATE Karen Midthun, M.D.
OFFICE OF THE Senior Advisor for Counterterrorism/Medical Countermeasures
Cynthia L. Kelley, M.S.
DIRECTOR Senior Advisor for Chemistry and Manufacturing Controls
Christopher C, Joneckis, Ph.D.
Senior Advisor for International Affairs
Joan Wilmarth Blair
Special Assistant to the Director for Human Subject Protection
Richard D. Diamond, M.D., M.P.A.
Emergency Response Coordinator
George R. Gentile

Medical Director for Emerging & Associate Director for Review


Pandemic Threat Preparedness Management
(Vacant) Robert A. Yetter, Ph.D.

Senior Scientist for Emerging & Document Control Center


Pandemic Threat Preparedness Jules M. Meisler
Jean L. Hu-Primmer, M.S.

Associate Director for Policy Associate Director for Research Associate Director for Quality
Diane Maloney, J.D. Kathryn M. Carbone, M.D. Assurance
Sheryl L. Lard-Whiteford, Ph.D.

Regulations and Policy Staff Core Facilities Team Center Laboratory Quality Manager
*Stephen M. Ripley Nga Yen Nguyen, Ph.D. Deborah L. Jansen

Quality Assurance Staff

*Acting 10/07.3
CBER Director
OFFICE OF *Steven A. Anderson, Ph.D.
BIOSTATISTICS Deputy Director
AND Steven A. Anderson, Ph.D.
EPIDEMIOLOGY Associate Director for Risk Assessment
Mark O. Walderhaug, Ph.D.

Associate Director for Research


M. Miles Braun, M.D., M.P.H

Program Manager
Sylvia Gay

Division of Biostatistics Division of Epidemiology


Henry S. Hsu, Ph.D., M.P.H. M. Miles Braun, M.D., M.P.H

Vaccine Evaluation Branch Vaccine Safety Branch


A. Dale Horne, Dr.P.H. Robert Ball, M.D., M.P.H., Sc.M.

Therapeutics Evaluation Therapeutics and Blood Safety


Branch Branch
Ghanshyam Gupta, Ph.D. Robert P. Wise, M.D., M.P.H.

*Acting 10/07.4
CBER
OFFICE OF Director
COMMUNICATION, Lorrie H. McNeill
TRAINING AND Deputy Director
MANUFACTURERS (Vacant)
ASSISTANCE Program Manager
Kim Athey

Division of Manufacturers Division of Disclosure and Division of Communication


Assistance and Training Oversight Management and Consumer Affairs
Leslie D. Wheelock Joanne C. Binkley *Lorrie H. McNeill
Executive Secretariat Team
Diane Bartell

Career Development and Congressional and Oversight Communication Technology


Directed Training Branch Branch Branch
Laura L. Stewart Susan C. Frantz-Bohn Karen A. Groover

Manufacturers Assistance and Access Litigation and Freedom Consumer Affairs Branch
Technical Training Branch of Information Branch Christopher T. Middendorf
Adrienne Hornatko-Munoz Beth Brockner-Ryan

*Acting 10/07.5
CBER
Director
OFFICE OF Joseph A. Biviano Regulatory Information
MANAGEMENT Management Staff
Deputy Director Roger D. Eastep
James M. Sigg

Division of Program Services Division of Planning, Division of Scientific Division of Veterinary


David R. Leffler Evaluation, and Budget Advisors & Consultants Services
Karen M. O'Brien William Freas, Ph.D. Philip J. Snoy, D.V.M.
Assistant Director for Safety
Larry M. Solomon

Building Operations Staff Resource Management


*Catrina M. Posley Branch
Connie A. Giganti

Program Operations Planning and


Branch Evaluation Branch
Cynthia Hart-Smith Mary Pat Leary

Program Management
Services Branch
(Vacant)

*Acting 10/07.6
CBER
OFFICE OF
INFORMATION
TECHNOLOGY Director
Ginger G. Leo
Deputy Director
*Amy El Naggar

Chief Technical Officer


Marco S. Venida

Division of Information Division of Information


Technology Operations Technology Development
*Amy El Naggar *Nadia O. Davey

*Acting 10/07.7
Director
Jay S. Epstein, M.D.
CBER Deputy Director
Jonathan C. Goldsmith, M.D.
OFFICE OF BLOOD
Associate Deputy Director
RESEARCH AND Mark J. Weinstein, Ph.D.
REVIEW Associate Director for Policy & Communications
Jennifer B. Scharpf, M.P.H. Policy and Publications Staff
(Vacant)
Associate Director for Regulatory Affairs
Alan E. Williams, Ph.D.
Associate Director for Research
*Chintamani D. Atreya, Ph.D.
Special Assistant to the Director
Linda M. Alms
Program Manager
Kevin Kezer

Division of Emerging & Division of Hematology Division of Blood


Transfusion Transmitted Basil Golding, M.D. Applications
Diseases *Elizabeth G. Callaghan
Hira L. Nakhasi, Ph.D.

*Acting 10/07.8
CBER-OBRR
DIVISION OF
EMERGING &
TRANSFUSION Director
TRANSMITTED Hira L. Nakhasi, Ph.D. Product Testing Staff
Robin M. Biswas, M.D.
DISEASES Deputy Director
Paul A. Mied, Ph.D.

Laboratory of Bacterial, Parasitic, & Laboratory of Molecular Virology


Unconventional Agents Indira K. Hewlett, Ph.D.
David Asher, M.D.

Laboratory of Hepatitis & Related Product Review Branch


Emerging Agents Elliot P. Cowan, Ph.D.
Gerardo Kaplan, Ph.D.

10/07.9
*Acting
Director
Basil Golding, M.D.
CBER-OBRR Deputy Director
DIVISION OF Susan L. Abbondanzo, M.D.
HEMATOLOGY

Laboratory of Cellular Laboratory of Hemostasis Laboratory of Plasma


Hematology *Timothy K. Lee, Ph.D. Derivatives
Jaroslav G. Vostal, M.D., Ph.D. Dorothy E. Scott, M.D.

Clinical Review Branch Laboratory of Biochemistry


Toby A. Silverman, M.D. and Vascular Biology
Abdu Alayash, Ph.D.

*Acting 10/07.10
CBER-OBRR
DIVISION OF BLOOD
APPLICATIONS
Director
*Elizabeth G. Callaghan
Deputy Director
Elizabeth G. Callaghan

Blood and Plasma Branch Regulatory Product Management Devices Review Branch
Leslie G. Holness, M.D. Branch Sheryl A. Kochman
*Jeffrey M. Anderson

*Acting 10/07.11
Director
Norman W. Baylor, Ph.D.
Deputy Director
CBER Florence Houn, M.D.
OFFICE OF VACCINES Associate Director for Regulatory Policy
RESEARCH AND Marion F. Gruber, Ph.D.
REVIEW Associate Director for Science
Michael J. Brennan, Ph.D.
Associate Director, Management & Scientific Affairs Program Operation Staff
Erik A. Henchal, Ph.D. Linda H. Shone
Associate Director for Quality Assurance
(Vacant)
Special Assistant for Communication
Maureen A. Hess, M.P.H.
Program Manager
Linda H. Shone

Division of Bacterial, Division of Viral Division of Vaccines and Division of Product Quality
Parasitic & Allergenic Products Related Products William M. McCormick, Ph.D.
Products Jerry P. Weir, Ph.D. Applications
Richard I. Walker, Ph.D. *Paul G. Richman, Ph.D.

*Acting 10/07.12
CBER-OVRR
DIVISION OF
BACTERIAL, PARASITIC
& ALLERGENIC
PRODUCTS
Director
Richard I. Walker, Ph.D.
Deputy Director
Milan S. Blake, Ph.D.

Laboratory of Immunobiochemistry Laboratory of Bacterial Polysaccharides Laboratory of Mycobacterial Diseases &


Jay E. Slater, M.D. Willie F. Vann, Ph.D. Cellular Immunology
Sheldon L. Morris, Ph.D.

Laboratory of Respiratory and Special Laboratory of Enteric and Sexually Laboratory of Methods Development &
Pathogens Transmitted Diseases Quality Control
Drusilla L. Burns, Ph.D. Dennis J. Kopecko, Ph.D. (Vacant)

10/07.13
CBER-OVRR
DIVISION OF VIRAL
PRODUCTS

Director
Jerry P. Weir, Ph.D.
Laboratory of Hepatitis Viruses
Deputy Director
Stephen M. Feinstone, M.D.
Philip R. Krause, M.D.

Laboratory of Vector Borne Diseases Laboratory of Retroviruses Laboratory of DNA Viruses


Lewis J. Markoff, M.D. Hana Golding, Ph.D. Andrew M. Lewis, M.D.

Laboratory of Pediatric and Laboratory of Method Development Laboratory of Immunoregulation


Respiratory Viral Diseases Konstantin M. Chumakov, Ph.D. Ira J. Berkower, M.D., Ph.D.
*Jerry P. Weir, Ph.D.

*Acting 10/07.14
CBER-OVRR
DIVISION OF
VACCINES AND
RELATED PRODUCTS
APPLICATIONS Director
*Paul G. Richman, Ph.D.
Deputy Director
*Loris D. McVittie, Ph.D.

Viral Vaccines Branch Bacterial Vaccines Branch Vaccine Clinical Trials Branch
Loris D. McVittie, Ph.D. Paul G. Richman, Ph.D. Douglas R. Pratt, M.D.

*Acting 10/07.15
CBER-OVRR
DIVISION OF
PRODUCT QUALITY

Director
William M. McCormick, Ph.D.

Product Quality Laboratory Staff Quality Assurance Staff Validation Staff


Rajesh K. Gupta, Ph.D. (Vacant) Lokesh Bhattacharyya, Ph.D.

*Acting 10/07.16
Director
CBER Mary Anne Malarkey
OFFICE OF Deputy Director
Leslie Kux
COMPLIANCE AND
Special Assistant to the Director
BIOLOGICS Thomas J. Adams
QUALITY Associate Director for Policy
Anita F. Richardson
Associate Director for Regulatory Policy
Jessica A. Tave
Assistant to the Director for Labeling Policy and
Medical Communication
(Vacant)
Assistant to the Director for Manufacturing & Policy
(Vacant)
Program Manager
Peggy Noland

Division of Case Management Division of Inspections and Division of Manufacturing


Robert A. Sausville Surveillance and Product Quality
Gilliam B. Conley John A. Eltermann, Jr.

*Acting 10/07.17
CBER - OCBQ
DIVISION OF CASE
MANAGEMENT

Director
Robert A. Sausville

Advertising and Promotional Labeling Biological Drug & Device Compliance Blood and Tissue Compliance Branch
Branch Branch Stephany J. Wesley
Ele Ibarra-Pratt, R.N., B.S.N., M.P.H. Diane S. Alexander

*Acting 10/07.18
CBER - OCBQ
DIVISION OF
INSPECTIONS &
SURVEILLANCE

Director
Gilliam B. Conley

Bioresearch Monitoring Branch Program Surveillance Branch Program Inspection Branch


Patricia A. Holobaugh Janet L. Ishimoto (Vacant)

*Acting 10/07.19
CBER - OCBQ
DIVISION OF
MANUFACTURING
AND PRODUCT
QUALITY Director
John A. Eltermann, Jr.

Deputy Director
Laurie P. Norwood

Product Release Branch Manufacturing Review Branch I Manufacturing Review Branch II


Joseph Quander, III Carolyn A. Renshaw Chiang Syin, Ph.D.

*Acting 10/07.20
CBER
OFFICE OF CELLULAR,
TISSUE AND GENE
Director
THERAPIES Celia M. Witten, M.D., Ph.D.
Deputy Director
Stephanie L. Simek, Ph.D.
Regulatory Management Staff
Associate Director for Research
*Stephanie L. Simek, Ph.D.
Suzanne L. Epstein, Ph.D.
Associate Director for Policy
Richard D. McFarland, M.D.
Program Manager
Anne E. Wilcox

Division of Cellular and Gene Division of Clinical Evaluation and Division of Human Tissues
Therapies Pharmacology/Toxicology Ruth R. Solomon, M.D.
Raj K. Puri, M.D., Ph.D. Ashok K. Batra, M.D.

*Acting 10/07.21
CBER - OCTGT
DIVISION OF
CELLULAR AND GENE
THERAPIES

Director
Raj K. Puri, M.D., Ph.D.

Deputy Director
Kimberly A. Benton, Ph.D.

Cell Therapies Branch Gene Therapies Branch Gene Transfer and


Keith M. Wonnacott. PhD. Daniel M. Takefman, Ph.D. Immunogenicity Branch
Eda T. Bloom, Ph.D.

Tumor Vaccines and Cellular and Tissue Therapy Branch


Biotechnology Branch *Steven R. Bauer, Ph.D.
*Raj K. Puri, M.D., Ph.D.

*Acting 10/07.22
CBER - OCTGT
DIVISION OF CLINICAL
EVALUATION AND
PHARMACOLOGY/
TOXICOLOGY

Director
Ashok K. Batra, M.D.

Clinical Evaluation Branch Pharmacology/Toxicology Branch


Peter F. Bross Mercedes A. Serabian, M.S., DABT

*Acting 10/07.23
CBER - OCTGT
DIVISION OF
HUMAN TISSUES

Director
Ruth R. Solomon, M.D.

Human Tissue and Reproduction


Branch
Martha A. Wells, M.P.H.

*Acting 10/07.24

Related Interests