Revised Draft #3:12/10/2002

 

BLOOD PRODUCTS ADVISORY COMMITTEE

75th Meeting December 12, 2002

Gaithersburg Holiday Inn

2 Montgomery Village Avenue

Gaithersburg, MD 20877

 

Thursday, December 12, 2002

8:00 a.m. Welcome, Statement of Conflict of Interest, Announcements

8:10 am. Committee Updates

 

        Summary of Workshop on West Nile Virus, November 4-5, 2002 Hira Nakhasi, Ph.D.

        Medical Device User Fees (MDUFMA) Mary Elizabeth Jacobs, Ph.D.

        Approval of the OraQuick Rapid HIV-1 Antibody Test Elliot Cowan, Ph.D.

 

9:10 a.m. Open Committee Discussion

I. Bacterial Contamination

A. Background and Introduction Alan Williams, Ph.D., Director, Division of Blood Applications, OBRR

B. Skin Preparation of Phlebotomy John Lee, M.D., Chief, Blood and Plasma Branch, DBA,OBRR

C. Update on the Diversion Pouch Jaro Vostal, M.D., Ph.D., Chief, Laboratory of Cellular Hematology, DH, OBRR

10:00 a.m. BREAK

 

10:15 a.m. Open Committee Discussion

D. Quality Control Approaches for Detection of Bacterial Contamination Alan Williams, Ph.D.

E. Data Presentation James Aubuchon, M.D.

F. Data Presentation Tracey Manlove, MT, Terumo Corporation

G. Design of Clinical Trials for Clearance of Devices Intended for Screening of Platelet Products Prior to Transfusion: Background Steven Wagner, Ph.D., American Red Cross, Holland Lab.

 

H. Data Presentation James Aubuchon, M.D.

I. Proposed Study Design Jaro Vostal, M.D., Ph.D.

 

12:30 p.m. OPEN PUBLIC HEARING

 

1:00 p.m. Open Committee Discussion

 

J. Questions for the Committee

K. Committee Discussion and Recommendations

 

1:45 p.m. LUNCH

2:30 p.m. Open Committee Discussion

 

II. Human Parvovirus B19 NAT Testing for Whole Blood and Source Plasma

 

A. Introduction and Background Mei-ying W.Yu Ph.D., Laboratory of Plasma Derivatives, DH

B. Overview of Parvovirus B19 Infection Kevin Brown, MD, Hematology Branch, NHLBI

C. Industry Data Presentations

        American Red Cross Susan Stramer, Ph.D.

        National Genetics Institute Andrew Conrad, Ph.D.

        Fractionators/PPTA

1.  Barbee Whitaker, Ph.D.

2.  Steve Petteway, Ph.D.

3.  Edward Gomperts, M.D.

 

4:15 p.m. BREAK

4:30 p.m. OPEN PUBLIC HEARING

5:15 p.m. Open Committee Discussion

 

D. FDA Perspectives and Questions for the Committee Mei-ying W.Yu, Ph.D.

E. Committee Discussion and Recommendations

6:30 p.m. ADJOURNMENT