Draft Agenda:12/9/2003 1:01 PM



78th Meeting – December 11-12, 2003

Hilton Gaithersburg, 620 Perry Parkway

Gaithersburg, MD 20877


Thursday, December 11, 2003


 8:00 a.m.  Welcome, Statement of Conflict of Interest, Announcements


8:05 a.m.    Open Committee Discussion


I.                       American Association for Blood Banks (AABB) Abbreviated Questionnaire

A.                       Introduction and Background – Judy Ciaraldi, MT (ASCP) SBB, Consumer Safety Officer, OBRR (15’)

B.                       AABB UDHQ Task Force Perspective on Abbreviated Questionnaires – Mary Townsend, MD, Chair, UDHQ Task Force (15’)

C.                       FDA Regulatory and Review Issues

-                        Judy Ciaraldi, MT (ASCP) SBB, Consumer Safety Officer, OBRR (15’)

-                         Sharon O’Callaghan, MT (ASCP), Consumer Safety Officer, OCBQ (15’)

D.                       Experiences Using Abbreviated Questionnaires

-                        Mary Beth Bassett, MS, MT(ASCP) SBB, Blood Systems, Inc.(15’)

-                        Stacy Sime, MS, MT (ASCP) SBB, The Blood Center of Iowa (15’)

                  E.  Can Abbreviated Questionnaires Be                                     Studied/Tested? – Paul Beatty, PhD, NCHS,CDC                         (15’)

   F.  What Are the Behavioral Issues of a                    Questionnaire – Alan Williams, PhD, Director,          Division of Blood Applications, OBRR (10’)


 10:05 a.m.    BREAK


 10:30 a.m.    OPEN PUBLIC HEARING


 11:00 a.m     Open Committee Discussion

                  G.  FDA Current Thinking and Questions for the                            Committee

H.  Committee Discussion and Recommendations




 11:30 a.m.  II.  Potential Recommendations on Blood Donor Deferral                     for  Leishmaniasis and Its Exposure

                  A. Introduction and Background – Robert Duncan,                          PhD, DETTD, OBRR (20’)

 B. Leishmania Pathogenesis and Epidemiology –          Barbara Herwaldt, MD  CDC (25’)

 C. Department of Defense Leishmaniasis Donor           Deferral Policy - Ruth Sylvester, DoD (25’)

 D. Impact of Leishmaniasis Donor Deferral Policy on     the Blood Supply – Sharyn Orton, PhD, DBA,          OBRR (20’)


  1:00 p.m.   LUNCH    




  2:30 p.m.   Open Committee Discussion


                  E. FDA Position and Questions for the Committee

 F. Committee Discussion and Recommendations


   3:00 p.m.  III. Update on West Nile Virus Epidemic and Donor                          Testing in 2003

                  A. Introduction and Background – Hira Nakhasi,                           PhD (20’)

B. Update on Epidemiology Including Reports of        Transfusion-Transmitted Cases – Anthony Marfin,    MD, CDC (20’)


  3:35 p.m.   BREAK


  3:50 p.m.     Open Committee Discussion


C. Updates on WNV Testing Under IND and Plans for     2004

D. Status Reports

1.                       Prospective and Retrospective Testing Using ID-NAT and Update on Relative Sensitivity  Study for WNV NAT Testing

–                       Michael Busch, MD, PhD (25’)

2. Prospective and Retrospective Testing Using    ID-NAT –Susan Stramer, PhD (15’)

3. Update on Infectivity Study – Indira          Hewlett, PhD (10’)




            American Association of Blood Banks – TBA (5’)

            America’s Blood Centers – TBA (5’)


 5:45 p.m.   Open Committee Discussion

E. Committee Discussion


 6:30 p.m.   RECESS(8:00 a.m. Friday, December 12, 2003)



Friday, December 12, 2003


8:00 a.m.  Committee Updates

·        Medical Device User Fee Act Update – Mary E. Jacobs, PhD (10’)

·        Use of Secure E-Mail – Michael Fauntleroy (10’)

·        Summary of Factor VIII Inhibitor Workshop –Jay Lozier (15’)

·        Platelet Testing and Evaluation Guidance – Jaro Vostal, MD, PhD (15’)

·        Freezing and Storage Temperatures for Source Plasma and Fresh Frozen Plasma – Elizabeth Callaghan (20’)




10:15 a.m. BREAK


10:45 a.m.  IV. Review of Plasma Collection Nomograms                                 A. Introduction and Background – Les Holness, MD,                        Medical Officer, Division of Blood Applications

                B. Review of Nomogram Volumes – Larry Landow, MD,                        Medical Officer, Division of Hematology

                C. Review of Statistical Data – Timothy Cote, MD, OBE                 D. Experience in Other Countries – tbd

E. Safety of High Volume Collections - PPTA




12:30 p.m.  LUNCH


 1:30 p.m.  Open Committee Discussion


F. FDA Current Thinking and Questions for the           Committee

G. Committee Discussion


   3:00 p.m.   ADJOURNMENT