CENTER FOR BIOLOGICS EVALUATION AND RESEARCH

Office of Information Technology Ginger G. Leo

Director: Jesse L. Goodman, M.D., M.P.H.
Deputy Director: Karen Midthun, M.D. Associate Director for Research: Kathryn M. Carbone, M.D. Associate Director for Policy: Diane Maloney, J.D. Associate Director for Quality Assurance: Sheryl L. Lard-Whiteford, Ph.D. Associate Director for Review Management: Robert A. Yetter, Ph.D. Medical Dir. for Emerging & Pandemic Threat Preparedness: (Vacant) 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.

Office of Biostatistics and Epidemiology *Steven A. Anderson, Ph.D.

Division of Information Operations *Amy El Naggar Division of Information Development *Nadia O. Davey

Division of Biostatistics Henry S. Hsu, Ph.D., M.P.H.

Division of Epidemiology M. Miles Braun, M.D., M.P.H.

Office of Cellular, Tissue and Gene Therapies Celia M. Witten, M.D., Ph.D.

Office of Communication, Training and Manufacturers Assistance Lorrie H. McNeill

Office of Blood Research and Review Jay S. Epstein, M.D.

Office of Vaccines Research and Review Norman W. Baylor, Ph.D.

Office of Compliance and Biologics Quality Mary A. Malarkey

Office of Management Joseph A. Biviano

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

Division of Manufacturers Assistance and Training Leslie D. Wheelock Division of Disclosure and Oversight Management Joanne C. Binkley Division of Communication and Consumer Affairs *Lorrie H. McNeill

Division of Emerging Transfusion Transmitted Diseases Hira L. Nakhasi, Ph.D. Division of Hematology Basil Golding, M.D.

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

Division of Case Management Robert A. Sausville Division of Inspections and Surveillance Gilliam B. Conley

Division of Planning, Evaluation, and Budget Karen M. O'Brien Division of Program Services David R. Leffler Division of Scientific Advisors & Consultants William Freas, Ph.D.

Division of Blood Applications *Elizabeth G. Callaghan

Division of Manufacturing and Product Quality John A. Eltermann, Jr.

Division of Veterinary Services Philip J. Snoy, D.V.M.

*Acting

10/07.1

CENTER FOR BIOLOGICS EVALUATION AND RESEARCH

Director Jesse L. Goodman, M.D., M.P.H.
Deputy Director Karen Midthun, M.D. Associate Director for Policy Diane Maloney, J.D. Associate Director for Quality Assurance Sheryl L. Lard-Whiteford, Ph.D. 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 Epidemiology *Steven A. Anderson, Ph.D.

Office of Communication, Training & Manufacturers Assistance Lorrie H. McNeill

Office of Management Joseph A. Biviano

Office of Information Technology Ginger G. Leo

Office of Blood Research and Review Jay S. Epstein, M.D.

Office of Vaccines Research and Review Norman W. Baylor, Ph.D.

Office of Compliance and Biologics Quality Mary Anne Malarkey

Office of Cellular, Tissue and Gene Therapies Celia M. Witten, M.D., Ph.D.

*Acting

10/07.2

CBER IMMEDIATE OFFICE OF THE DIRECTOR

Director Jesse L. Goodman, M.D., M.P.H.
Deputy Director Karen Midthun, M.D. Senior Advisor for Counterterrorism/Medical Countermeasures Cynthia L. Kelley, M.S. 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 & Pandemic Threat Preparedness (Vacant) Senior Scientist for Emerging & Pandemic Threat Preparedness Jean L. Hu-Primmer, M.S.

Associate Director for Review Management Robert A. Yetter, Ph.D. Document Control Center Jules M. Meisler

Associate Director for Policy Diane Maloney, J.D.

Associate Director for Research Kathryn M. Carbone, M.D.

Associate Director for Quality Assurance Sheryl L. Lard-Whiteford, Ph.D. Center Laboratory Quality Manager Deborah L. Jansen Quality Assurance Staff

Regulations and Policy Staff *Stephen M. Ripley

Core Facilities Team Nga Yen Nguyen, Ph.D.

*Acting

10/07.3

CBER OFFICE OF BIOSTATISTICS AND EPIDEMIOLOGY

Director *Steven A. Anderson, Ph.D.
Deputy Director Steven A. Anderson, Ph.D. 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 Henry S. Hsu, Ph.D., M.P.H.

Division of Epidemiology M. Miles Braun, M.D., M.P.H

Vaccine Evaluation Branch A. Dale Horne, Dr.P.H.

Vaccine Safety Branch Robert Ball, M.D., M.P.H., Sc.M.

Therapeutics Evaluation Branch Ghanshyam Gupta, Ph.D.

Therapeutics and Blood Safety Branch Robert P. Wise, M.D., M.P.H. 10/07.4

*Acting

CBER OFFICE OF COMMUNICATION, TRAINING AND MANUFACTURERS ASSISTANCE

Director Lorrie H. McNeill
Deputy Director (Vacant) Program Manager Kim Athey

Division of Manufacturers Assistance and Training Leslie D. Wheelock

Division of Disclosure and Oversight Management Joanne C. Binkley

Division of Communication and Consumer Affairs *Lorrie H. McNeill
Executive Secretariat Team Diane Bartell

Career Development and Directed Training Branch Laura L. Stewart

Congressional and Oversight Branch Susan C. Frantz-Bohn

Communication Technology Branch Karen A. Groover

Manufacturers Assistance and Technical Training Branch Adrienne Hornatko-Munoz

Access Litigation and Freedom of Information Branch Beth Brockner-Ryan

Consumer Affairs Branch Christopher T. Middendorf

*Acting

10/07.5

CBER OFFICE OF MANAGEMENT

Director Joseph A. Biviano
Deputy Director James M. Sigg

Regulatory Information Management Staff Roger D. Eastep

Division of Program Services David R. Leffler
Assistant Director for Safety Larry M. Solomon

Division of Planning, Evaluation, and Budget Karen M. O'Brien

Division of Scientific Advisors & Consultants William Freas, Ph.D.

Division of Veterinary Services Philip J. Snoy, D.V.M.

Building Operations Staff *Catrina M. Posley

Resource Management Branch Connie A. Giganti

Program Operations Branch Cynthia Hart-Smith

Planning and Evaluation Branch 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 Technology Operations *Amy El Naggar

Division of Information Technology Development *Nadia O. Davey

*Acting

10/07.7

Director Jay S. Epstein, M.D.

CBER OFFICE OF BLOOD RESEARCH AND REVIEW

Deputy Director Jonathan C. Goldsmith, M.D. Associate Deputy Director Mark J. Weinstein, Ph.D. Associate Director for Policy & Communications Jennifer B. Scharpf, M.P.H. 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 Policy and Publications Staff (Vacant)

Division of Emerging & Transfusion Transmitted Diseases Hira L. Nakhasi, Ph.D.

Division of Hematology Basil Golding, M.D.

Division of Blood Applications *Elizabeth G. Callaghan

*Acting

10/07.8

CBER-OBRR DIVISION OF EMERGING & TRANSFUSION TRANSMITTED DISEASES

Director Hira L. Nakhasi, Ph.D.
Deputy Director Paul A. Mied, Ph.D.

Product Testing Staff Robin M. Biswas, M.D.

Laboratory of Bacterial, Parasitic, & Unconventional Agents David Asher, M.D.

Laboratory of Molecular Virology Indira K. Hewlett, Ph.D.

Laboratory of Hepatitis & Related Emerging Agents Gerardo Kaplan, Ph.D.

Product Review Branch Elliot P. Cowan, Ph.D.

10/07.9 *Acting

CBER-OBRR DIVISION OF HEMATOLOGY

Director Basil Golding, M.D.
Deputy Director Susan L. Abbondanzo, M.D.

Laboratory of Cellular Hematology Jaroslav G. Vostal, M.D., Ph.D.

Laboratory of Hemostasis *Timothy K. Lee, Ph.D.

Laboratory of Plasma Derivatives Dorothy E. Scott, M.D.

Clinical Review Branch Toby A. Silverman, M.D.

Laboratory of Biochemistry 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 Leslie G. Holness, M.D.

Regulatory Product Management Branch *Jeffrey M. Anderson

Devices Review Branch Sheryl A. Kochman

*Acting

10/07.11

Director Norman W. Baylor, Ph.D.

CBER OFFICE OF VACCINES RESEARCH AND REVIEW

Deputy Director Florence Houn, M.D. Associate Director for Regulatory Policy Marion F. Gruber, Ph.D. Associate Director for Science Michael J. Brennan, Ph.D. Associate Director, Management & Scientific Affairs Erik A. Henchal, Ph.D. Associate Director for Quality Assurance (Vacant) Special Assistant for Communication Maureen A. Hess, M.P.H. Program Manager Linda H. Shone

Program Operation Staff Linda H. Shone

Division of Bacterial, Parasitic & Allergenic Products Richard I. Walker, Ph.D.

Division of Viral Products Jerry P. Weir, Ph.D.

Division of Vaccines and Related Products Applications *Paul G. Richman, Ph.D.

Division of Product Quality William M. McCormick, 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 Jay E. Slater, M.D.

Laboratory of Bacterial Polysaccharides Willie F. Vann, Ph.D.

Laboratory of Mycobacterial Diseases & Cellular Immunology Sheldon L. Morris, Ph.D.

Laboratory of Respiratory and Special Pathogens Drusilla L. Burns, Ph.D.

Laboratory of Enteric and Sexually Transmitted Diseases Dennis J. Kopecko, Ph.D.

Laboratory of Methods Development & Quality Control (Vacant)

10/07.13

CBER-OVRR DIVISION OF VIRAL PRODUCTS
Director Jerry P. Weir, Ph.D.
Deputy Director Philip R. Krause, M.D.

Laboratory of Hepatitis Viruses Stephen M. Feinstone, M.D.

Laboratory of Vector Borne Diseases Lewis J. Markoff, M.D.

Laboratory of Retroviruses Hana Golding, Ph.D.

Laboratory of DNA Viruses Andrew M. Lewis, M.D.

Laboratory of Pediatric and Respiratory Viral Diseases *Jerry P. Weir, Ph.D.

Laboratory of Method Development Konstantin M. Chumakov, Ph.D.

Laboratory of Immunoregulation Ira J. Berkower, M.D., 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 Loris D. McVittie, Ph.D.

Bacterial Vaccines Branch Paul G. Richman, Ph.D.

Vaccine Clinical Trials Branch 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 Rajesh K. Gupta, Ph.D.

Quality Assurance Staff (Vacant)

Validation Staff Lokesh Bhattacharyya, Ph.D.

*Acting

10/07.16

CBER OFFICE OF COMPLIANCE AND BIOLOGICS QUALITY

Director Mary Anne Malarkey
Deputy Director Leslie Kux Special Assistant to the Director Thomas J. Adams 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 Robert A. Sausville

Division of Inspections and Surveillance Gilliam B. Conley

Division of Manufacturing and Product Quality John A. Eltermann, Jr.

*Acting

10/07.17

CBER - OCBQ DIVISION OF CASE MANAGEMENT

Director Robert A. Sausville

Advertising and Promotional Labeling Branch Ele Ibarra-Pratt, R.N., B.S.N., M.P.H.

Biological Drug & Device Compliance Branch Diane S. Alexander

Blood and Tissue Compliance Branch Stephany J. Wesley

*Acting

10/07.18

CBER - OCBQ DIVISION OF INSPECTIONS & SURVEILLANCE
Director Gilliam B. Conley

Bioresearch Monitoring Branch Patricia A. Holobaugh

Program Surveillance Branch Janet L. Ishimoto

Program Inspection Branch (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 Joseph Quander, III

Manufacturing Review Branch I Carolyn A. Renshaw

Manufacturing Review Branch II Chiang Syin, Ph.D.

*Acting

10/07.20

CBER OFFICE OF CELLULAR, TISSUE AND GENE THERAPIES

Director Celia M. Witten, M.D., Ph.D.
Deputy Director Stephanie L. Simek, Ph.D. Associate Director for Research Suzanne L. Epstein, Ph.D. Associate Director for Policy Richard D. McFarland, M.D. Program Manager Anne E. Wilcox Regulatory Management Staff *Stephanie L. Simek, Ph.D.

Division of Cellular and Gene Therapies Raj K. Puri, M.D., Ph.D.

Division of Clinical Evaluation and Pharmacology/Toxicology Ashok K. Batra, M.D.

Division of Human Tissues Ruth R. Solomon, 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 Keith M. Wonnacott. PhD.

Gene Therapies Branch Daniel M. Takefman, Ph.D.

Gene Transfer and Immunogenicity Branch Eda T. Bloom, Ph.D.

Tumor Vaccines and Biotechnology Branch *Raj K. Puri, M.D., Ph.D.

Cellular and Tissue Therapy Branch *Steven R. Bauer, Ph.D.

*Acting

10/07.22

CBER - OCTGT DIVISION OF CLINICAL EVALUATION AND PHARMACOLOGY/ TOXICOLOGY
Director Ashok K. Batra, M.D.

Clinical Evaluation Branch Peter F. Bross

Pharmacology/Toxicology Branch 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