BLOOD PRODUCTS
ADVISORY COMMITTEE
89th Meeting – April 26-27, 2007
Thursday,
April 26, 2007
2:00
p.m. Opening Remarks, Frederick P. Siegal, M.D., Medical
Director,
Saint Vincent’s
Statement of Conflict of Interest,
Acknowledgement of New Members, Announcements
2:10 p.m. Committee Update
-
Summary of August
30-31, 2006 Meeting of the DHHS Advisory Committee on Blood Safety and Availability, Jerry Holmberg,
PhD, Executive Secretary, Advisory Committee on Blood Safety and
Availability (15’)
2:25 p.m.
Topic I:
Issues Related to Implementation of Blood Donor Screening for Infection
with Trypanosoma cruzi and the Potential Transmission of Trypanosoma cruzi by Human Cells, Tissue
and Cellular and Tissue-Based Products
A. Introduction and Issues Related to Implementation of Blood Donor Screening for Antibodies to T. cruzi Infection, Robert Duncan, Ph.D., DETTD, OBRR, FDA (20’)
B.
Introduction of Issues
Related to the Potential Transmission of T.
cruzi by Human Cells, Tissues and
Cellular and Tissue-Based Products, Melissa A. Greenwald, M.D., CDR, USPHS, DHT,
OCTGT, FDA (20’)
C.
Ortho T. cruzi ELISA Test System Experience, Susan
Stramer, Ph.D., American Red Cross (20’)
D.
Public Health Impact
of Donor Screening for T. cruzi Infection,
Susan Montgomery, D.V.M., M.P.H., Centers for Disease Control and Prevention
(20’)
E.
Potential Strategies
for Targeted Testing for T. cruzi Infection
in Repeat Donors, Michael Busch, M.D., Ph.D./ Brian Custer, Ph.D., M.P.H., Blood Systems Research Institute (30’)
4:15 p.m.
Break
4:30 p.m. Open
Public Hearing
5:00 p.m. Open
Committee Discussion
F. Questions for the Committee
G. Committee Discussion
6.00 p.m.
Adjournment
Friday,
April 27, 2007
8:00 a.m.
Committee Updates
- Summary
of December 15, 2006 Meeting of the Transmissible Spongiform Encephalopathies
Advisory Committee and FDA’s Risk
Communication on Plasma Derived Factor VIII and Factor XI,
Dorothy Scott, M.D., DH, OBRR, FDA and Mark Weinstein, Ph.D, OBRR, FDA
(25’)
- Summary of September 25-26, 2006 FDA Workshop
on Molecular Methods in Immunohematology, Sheryl Kochman, DBA, OBRR, FDA (15’)
8:40 a.m. Topic II:
Transfusion Related Acute Lung Injury (TRALI)
A.
Introduction, Alan Williams, Ph.D., DBA, OBRR, FDA (10’)
B.
Clinical and Laboratory Aspects of TRALI, David Stroncek, M.D., National
Institutes of Health (30’)
C. Current Use
of Transfusable Plasma, Ravindra Sarode, M.D., University of
D. Review
of REDS-II LAPS Study on HLA and Granulocyte Antibody Prevalence in Blood
Donors, Steven Kleinman, M.D., Kleinman
Biomedical Research (20’)
E. American Red
Cross Experience with TRALI, Richard Benjamin, M.D., American Red Cross (15’)
F. America’s
Blood Centers Experience with TRALI, Celso Bianco, M.D.,
10:30 a.m.
Break
10:45 a.m.
Open Public Hearing
11:15 a.m. Open
Committee Discussion
F. Questions for the Committee
G. Committee Discussion
12:15 p.m.
Lunch
1:15 p.m. Topic III: Issues Related to Implementation of
A.
Update on WNV Epidemic 2006, Eileen Farnon,
M.D., Centers for
Disease Control and Prevention (15’)
B. Issues for Testing, Maria Rios, Ph.D., DETTD,
OBRR, FDA (25’)
i. Approaches to Confirmatory Testing
ii. Donor and Unit Management
iii. Approaches
to ID-NAT Trigger
C. Data in Support of the Current ID-NAT Triggers,
Susan Stramer, Ph.D., American Red Cross (20’)
2:15 p.m. Open Committee Discussion
3:15 p.m. Adjournment