Revised Draft #3:12/10/2002
BLOOD PRODUCTS ADVISORY COMMITTEE
75th Meeting – December 12, 2002
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.
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