††††††††††††††††††††††† ††††††††††† BLOOD PRODUCTS ADVISORY COMMITTEE

 

††††††††††† ††††††††††† CENTER FOR BIOLOGICS EVALUATION AND RESEARCH

 

††††††††††††††††††††††† ††††††††††††††††††††††† ††††††††††† November 3-4, 2005

 

 

CHAIRMAN†††††††† ††††††††††††††††††††††††††††††† ††††††††††††††††††††††††††††††† ††††† ††††††††††††††† CHAIRMAN (Topic I only)TVM

Allen, James R., M.D., M.P.H.9/30/06†††††††††††††††††† †††† ††††††††††††††† DiMichele, Donna M., M.D.

President and CEO††††††††††††††††††††††† ††††††††††††††††††††††††††††††† ††††††††††††††††††† Assoc Prof of Pediatrics & Public Health

American Social Health Administration†††† ††††††††††††††† ††††† ††††††††† Weill Medical College & Graduate School

P.O. Box 13827††††† ††††††††††††††††††††††††††††††† ††††††††††††††††††††††††††††††† †††† ††††††††††††††† ††††of Medical Sciences

Research Triangle Park, NC 27709††††† ††††††††††††††††††††††††††††††† ††††† ††††††††††††††† Cornell University

††††††††††††††††††††††††††††††† ††††††††††††††††††††††††††††††† ††††† ††††††††††††††† †††††††††††††† ††††††††††††††† 525 East 68th Street, Room P-695

††††††††††††††††††††††††††††††† ††††††††††††††††††††††††††††††† ††††† ††††††††††††††† †††††††††††††† ††††††††††††††† New York, NY 10021

††††††††††††††† ††††††††††††††† ††††††††††††††††††††††††††††††† †††† ††††††††††††††† †††††††††††††††

††††††††††††††††††††††††††††††† ††††††††††††††††††††††††††††††† ††††††††††††††† ††††††† MEMBERS

 

Kuehnert, Matthew J., M.D.††† 9/30/07†††††††††††††††††† ††††††††††††††† Schreiber, George C., Sc.D.†† 9/30/07††

CDR, U.S. Public Health Service††††† ††††††††††††††††††††††††††††††† ††††††††††††††† Vice President, Health Studies

Assistant Director for Blood Safety†††††††††††††††††††† ††††††††††††††† ††††††††††††††† Westat

Division of Viral and Rickettsial Diseases††††††††††††††† ††††††††††††††† ††††††††††††††† 1650 Research Blvd., WB272

Centers for Disease Control and Prevention (CDC)†††† ††††††††††††††† Rockville, MD 20850

1600 Clifton Road, Mailstop A-30†††††††††††††††††††††† †††††††††††††††††††††††††††††††

Atlanta, GA 30333††††††††††††††††††††† ††††††††††††††††††††††††††††††† †††††††††††††††

††††††††††††††††††††††††††††††† ††††††††††††††† ††††††††††††††† ††††††††††††††††††††††††††††††† ††††††††††††††† Whittaker, Donna S., Ph.D.††† 9/30/07

††††††††††††††††††††††††††††††† ††††††††††††††††††††††††††††††† ††††††††††††††††††††††††††††††† ††††††††††††††† Director

Manno, Catherine S., M.D.††† 9/30/07 ††††††††††††††† ††††††††††††††† Robertson Blood Center (MCXI-BBC)

Professor of Pediatrics†††††††††††††† ††††††††††††††††††††††††††††††† ††††††††††††††† ††††††††††††††† 36000 Darnall Loop, Box #7

The Childrenís Hospital of Philadelphia††††††††† ††††††††††††††† ††††††††††††††† Fort Hood, TX 76544

University of Pennsylvania School of Medicine†††††††††††††† †††††††††††††††

9th Floor, Main Hospital†††††††††††††††† ††††††††††††††††††††††††††††††† †††††††††††††††

34th Street and Civic Center Boulevard††††††††††††† ††††††††††††††† ††††††††††††††† CONSUMER REPRESENTATIVE

Philadelphia, PA 19104††††††††††††††††††††† ††††††††††††††††††††††††††††††† ††††††††††††††† Baker, Judith R., M.H.S.A.9/30/08

††††††††††††††††††††††††††††††† ††††††††††††††††††††††††††††††† ††††††††††††††††††††††††††††††† ††††††††††††††† Regional Coordinator

Quirolo, Keith C., M.D.††† 9/30/07††††††††††††††† *††††††††††††† ††††††††††††††† ††††††††††††††† Federal Hemophilia Treatment Centers/

Hemoglobinopathy Pediatrician††††††† ††††††††††††††††††††††††††††††† ††††††††††††††† Region IX

Clinical Director, Apheresis††††††††††††† ††††††††††††††††††††††††††††††† ††††††††††††††† Childrenís Hospital Los Angeles

Transfusion Medical Director, Sibling††††††††††††††††††† ††††††††††††††† 4650 Sunset Boulevard, Box 54

Donor Cord Blood Program††††† ††††††††††††††††††††††††††††††† ††††††††††††††† Los Angeles, CA 90028

Department of Hematology

Childrenís Hospital & Research Center at Oakland

747 52nd Street

Oakland, CA 94609-1809

†††††††††††††††

NON-VOTING INDUSTRY REP††††††††††††††††††††††††††††††† ††††††††††† ACTING NON-VOTING INDUSTRY REP

Katz, Louis M., M.D.†††† 9/30/08†††† *††††††††††††††††††††††††††††† ††††††††††††††† Duffell Jr., William H., Ph.D.

Executive Vice President, Medical Affairs††† ††††††††††††††† ††††††††††††††† Director of Government Affairs

Mississippi Valley Regional Blood Center†††††††† ††††††††††††††† ††††††††††††††† Regulatory Affairs/Quality Systems

5500 Lake View Parkway†††††††††††††††† ††††††††††††††††††††††††††††††† ††††††††††††††† Gambro BCT

Davenport, IA 52807††††††††††††††††††††† ††††††††††††††††††††††††††††††† ††††††††††††††† 10811 West Collins Avenue

††††††††††††††††††††††††††††††† ††††††††††††††††††††††††††††††† ††††††††††††††† ††††††††††††††† ††††††††††††††† Lakewood, CO 80215

†††††††††††††††

* not attending meeting††††††††††††††††† ††††††††††††††††††††††††††††††† ††††††††††††††††††††††††††††††† †††††††††††††††

††††††††††††††††††††††††††††††† ††††††††††††††††††††††††††††††† ††††††††††††††††††††††††††††††† †††††††††††††††

††††††††††††††††††††††††††††††† ††††††††††††††††††††††††††††††† ††††††††††††††††††††††††††††††† ††††††††††††††† ††††††††††††††† †††††††††††††††

†††††††††††††††

TEMPORARY VOTING MEMBERS

 

 

Cryer III, Henry M., M.D., Ph.D.††† ††††††††††††††††††††††††††††††† ††††††††††††††† Laal, Suman, Ph.D.

Chief, Trauma & Critical Care†††††††††† ††††††††††††††††††††††††††††††† ††††††††††††††† Assistant Professor

Division of General Surgery††† ††††††††††††††† ††††††††††††† ††††††††††††††† Dept of Pathology

University of California, Los Angeles†††††††††††††††† ††††††††††††††† New York University School of Medicine

10836 Le Conte Ave., Rm 72-178 CHS††††††††††††††††††††††† ††††††††††††††† 423 East 23rd Street, Rm. 18123N

Los Angeles, CA 90024-1602†††††††††††† ††††††††††††††††††††††††††††††† ††††††††††††††† VA Medical Center

††††††††††††††††††††††††††††††† ††††††††††††††††††††††††††††††† ††††††††††††††††††††††††††††††† ††††††††††††††† New York, NY 10010

Di Bisceglie, Adrian M., M.D.†† ††††††††††††††††††††††††††††††† †††††††††††††††

Professor of Medicine†††††††††††††† ††††††††††††††††††††††††††††††† ††††††††††††††† ††††††††††††††† Nelson, Kenrad E., M.D.

Chief of Hepatology†††††††††† ††††††††††††††††††††††††††††††† ††††††††††††††† ††††††††††††††† Professor, Dept of Epidemiology

Saint Louis University School of Medicine†††††††††† ††††††††††††††† ††††††††††††††† Johns Hopkins University

3635 Vista Avenue at Grand Boulevard††††††††††††† ††††††††††††††††††††††††††††††† School of Hygiene & Public Health

P.O. Box 15250††††† ††††††††††††††† ††††††††††††††† ††††††††††††††††††††††††††††††† ††††††††††††††† 615 Wolfe, Room E-7132

St. Louis, MO 63110-0250†††††††††††† ††††††††††††††††††††††††††††††† ††††††††††††††† Baltimore, MD 21205†††††††††

††††††††††††††††††††††††††††††† ††††††††††††††††††††††††††††††† †††††††††††††††††††††††††††††††

DiMichele, Donna M., M.D.†† ††††††††††††††††††††††††††††††† ††††††††††††††† Quinn, Thomas C., M.D.

Associate Prof of Pediatrics & Public Health††††††† ††††††††††††††† ††††††††††††††† Professor of Medicine & Deputy Director

Weill Medical College & Graduate School of †††††††††††††††††††††††††† ††Infectious Disease Division

Medical Sciences††††††††††††††† ††††††††††††††††††††††††††††††† ††††††††††††††† ††††††††††††††† The Johns Hopkins University

Cornell University†††††††††††† ††††††††††††††††††††††††††††††† ††††††††††††††† ††††††††††††††† Ross Research Building, Room 1159

525 East 68th Street, Room P-695††††††††††††††††††††††††† ††††††††††††††† ††††††††††††††† 720 Rutland Avenue††

New York, NY 10021††††††††††††††††††††† ††††††††††††††††††††††††††††††† ††††††††††††††† Baltimore, MD 21205

 

Doppelt, Samuel H., M.D.†††††††††††††††† ††††††††††††††††††††††††††††††† ††††††††††††††† Siegal, Frederick P., M.D.

Chief, Dept of Orthopedic Surgery††††††††††††††††† ††††††††††††††† ††††††††††††††† Med Director, Comprehensive HIV Center

The Cambridge Hospital†††††††††††††††† ††††††††††††††††††††††††††††††† ††††††††††††††† Saint Vincentís Catholic Medical Centers

1493 Cambridge Street††††††††††††††††††††† ††††††††††††††††††††††††††††††† ††††††††††††††† Saint Vincentís Manhattan

Cambridge, MA 02139††††††††††††††††††††† ††††††††††††††††††††††††††††††† ††††††††††††††† NR 1425

††††††††††††††† ††††††††††††††† ††††††††††††††††††††††††††††††† ††††††††††††††††††††††††††††††† ††††††††††††††† 153 West 11th Street

Klein, Harvey G., M.D.†††††††††††††††††††††† ††††††††††††††††††††††††††††††† ††††††††††††††† New York, NY 10011

Chief, Dept of Transfusion Medicine

National Institutes of Health††††††††††††††††††† ††††††††††††††† ††††††††††††††† Snider, Gordon L., M.D. (Topic II)

Warren G. Magnuson Clinical Center††††† ††††††††††††††† ††††††††††††††† Chestnut Hill, MA 02467

10 Center Dr., Bldg. 10, Rm. 1C711

Bethesda, MD 20892††††††††††††††††††††† ††††††††††††††††††††††††††††††† ††††††††††††††† Szymanski, Irma O.V., M.D.

††††††††††††††††††††††††††††††† ††††††††††††††††††††††††††††††† ††††††††††††††††††††††††††††††† ††††††††††††††† Professor of Pathology, Emerita

Kulkarni, Roshni, M.D.†††††††††††††††††††††† ††††††††††††††††††††††††††††††† ††††††††††††††† University of Massachusetts Medical Center

Prof & Division Chief, Pediatric & ††††††††††††††† ††††††††††††††† ††††††††††††††† ††††††††††††††† Department of Pathology

Adolescent Hematology/Oncology††††††††††††††††††††† ††††††††††††††† 55 Lake Avenue North

Michigan State University†††††††††††† ††††††††††††††††††††††††††††††† ††††††††††††††† ††††††††††††††† Worcester, MA 01655-0212

B-220 Clinical Center

EastLansing, MI 48824

 

††††††††††††††††††††††††††††††† ††††††††††††††††††††††††††††††† †††††††††††††††

†††††††††††††††

 

††††††††††††††††††††††††††††††† †††††††††††††††††††††††††††††††

††††††††††††††††††††††††††††††† ††††††††††††††††††††††††††††††† †††††††††††††††

††††††††††††††††††††††††††††††† ††††††††††††††††††††††††††††††† †††††††††††††††

 

††††††††††††††††††††††††††††††† †††††††††††††††††††††††††††††††

††††††††††††††††††††††††††††††† ††††††††††††††† ††††††††††††††† †††† GUEST SPEAKERS

 

Branson, Bernard, M.D.†††††††††††††††††††††† ††††††††††††††††††††††††††††††† ††††††††††††††† Schwarz, Hans Peter, M.D.

Associate Director for Laboratory Diagnostics†††††††††† ††††††††††††††† Associate Professor of Medicine

Center for Diseases Control††††††††††††††††††††††††††††††† ††††††††††††††† Vice President, Global Preclinical R&D

Division of HIV/AIDS Prevention†††††††††††† ††††††††††††††††††††††††††††††† ††††††††††††††† Baxter AG, Baxter Biosciences

1600 Clifton Road, Mailstop D-21††††††††††††††††††††††† ††††††††††††††† ††††††††††††††† Wagramerstrasse 17-19

Atlanta, GA 30333††††††††††††††††††††† ††††††††††††††††††††††††††††††† ††††††††††††††† A-1220 Vienna, Austria

††††††††††††††† ††††††††††††††† ††††††††††††††††††††††††††††††† ††††††††††††††† ††††††††††††††† †††††††††††††††

Brantly, Mark, M.D.†††††††††††††††††††††† ††††††††††††††††††††††††††††††† ††††††††††††††† Smith, Theresa L., M.D.

Professor of Medicine†††††††††††††† ††††††††††††††††††††††††††††††† ††††††††††††††† ††††††††††††††† LCDR, USPHS

Molecular Genetics and Microbiology††††††† ††††††††††††††† ††††††††††††††† Surveillance & Epidemiology Activity

Alpha One Foundation Research Professor†††††††††††††† ††††††††††††††† ††††††††††††††† Arboviral Diseases Branch

University of Florida School of Medicine†††††††††††††† ††††††††††††††† ††††††††††††††† Division of Vector-Borne Infectious Disease

Pulmonary & Critical Care Medicine Division ††††††††††††††† National Center for Infectious Diseases

JHMHC P.O. Box 100225††††††††††††††††††† ††††††††††††††††††††††††††††††† ††††††††††††††† Centers for Disease Control & Prevention

Gainesville, FL 32610††††††††††††††††††††† ††††††††††††††††††††††††††††††† ††††††††††††††† 3150 Rampart Rd.

††††††††††††††††††††††††††††††† ††††††††††††††††††††††††††††††† ††††††††††††††† ††††††††††††††† ††††††††††††††† Fort Collins, CO 80521

Holmberg, Jerry A., Ph.D†††††††††††††††† ††††††††††††††††††††††††††††††† †††††††††††††††

Senior Advisor for Blood Policy††††††††††††††††††††††††††††††† ††††††††††††††† ††††††††††††††† Sutton-Jones, Sue, M.S.††

Executive Secretary†††††††††††††† ††††††††††††††††††††††††††††††† ††††††††††††††† ††††††††††††††† Senior Vice President

Advisory Committee on Blood Safety†††††††† ††††††††††††††† ††††††††††††††† Regulatory Affairs & Quality Assurance

and Availability††††††††††††††††††††††††††††††† ††††††††††††††††††††††††††††††† ††††††††††††††† OraSure Technologies, Inc

Office of the Secretary, Office of Public Health††† ††††††††††††††† 220 East First Street

& Science††††††††††† ††††††††††††††††††††††††††††††† ††††††††††††††††††††††††††††††† ††††††††††††††† Bethlehem, PA 18015-1360

1101 Wooten Parkway, Suite 200††††††††††††††††††††††††† †††††††††††††††††††††††††††††††

Rockville, MD 20852††††††††††††††††††††† ††††††††††††††††††††††††††††††† ††††††††††††††† ††††††††††††††† ††††††††††††††††††††††††††††††† ††††††††††††††† ††††††††††††††† †††††††††††††††††††††††††††††††

Howerton, Devery, Ph.D.

Chief, Laboratory Practice Evaluation &

Genomics Branch

Center for Diseases Control

Division of Public Health Partnerships

4770 Buford Highway, Mailstop G-23

Atlanta, GA 30341

 

Inungu, Joseph, M.D., D.P.H.

Professor

Central Michigan University

School of Health Sciences, HPB 2241

Mt. Pleasant, MI 48859

 

 

 

 

 

 

 

 

 

 

 

 

 

 

††††††††††††††††††††††††††††††† ††††††††††††††† ††† FDA ADMINISTRATIVE PERSONNEL

 

 

EXECUTIVE SECRETARY†††††† ††††††††††††††††††††††††††††††† ††† COMMITTEE MANAGEMENT SPECIALIST

Jehn, Donald W., M.S.††††††††††††††††††††††† ††††††††††††††††††††††††††††††† ††† Muckelvene, Pearline K.

Executive Secretary†††††††††††††† ††††††††††††††††††††††††††††††† ††††††††††††††† ††† Division of Scientific Advisors & Consultants

Blood Products Advisory Committee†††††††††††† ††††††††††††††† ††† Center for Biologics Evaluation & Research

Division of Scientific Advisors & Consultants††††††††† ††† Food & Drug Administration

Center for Biologics Evaluation & Research††††††††††††††† ††††††††††††††† ††† 1401 Rockville Pike (HFM-71)

Food & Drug Administration†††† ††††††††††††††††††††††††††††††† ††† Rockville, MD 20852-1448

1401 Rockville Pike (HFM-71)††††† ††††††††††††††††††††††††††††††† †††

Rockville, MD 20852††††††††††††††††††††† ††††††††††††††††††††††††††††††† †††

 

Zullo, Susan A., Ph.D.††††††††††††††††††††† ††††††††††††††††††††††††††††††† ††† Dawson, Rhonda

Acting Associate Director for Policy†††††††††††††††††††† ††† Policy Analyst††††† †††††††††††††††

Office for Blood Research & Review†††††††††††††††††† ††† Office for Blood Research & Review

Center for Biologics Evaluation & Research††††††††††††††† ††††††††††††††† ††† Center for Biologics Evaluation & Research

Food & Drug Administration†††† ††††††††††††††††††††††††††††††† ††† Food & Drug Administration

1401 Rockville Pike (HFM-302)††† ††††††††††††††††††††††††††††††† ††† 1401 Rockville Pike (HFM-302)

Rockville, MD 20852††††††††††††††††††††† ††††††††††††††††††††††††††††††† ††† Rockville, MD 20852