89th Meeting – April 26-27, 2007

Hilton Hotel, Washington, DC North / Gaithersburg

620 Perry Parkway, Gaithersburg, MD 20877



Thursday, April 26, 2007


   2:00 p.m.    Opening Remarks, Frederick P. Siegal, M.D., Medical Director, Comprehensive HIV Center,

                       Saint Vincent’s Catholic Medical Centers, New York, NY, Chairperson, BPAC


                      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 Texas Southwestern       Medical Center (20’)


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., America’s Blood Centers (15’)               

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 West Nile Virus Testing  


                      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