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.
·
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