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