AGENDA ITEM - DAY 1

1(a): Should FDA recommend new deferral criteria for donors of transfusable components, to attempt to reduce the theoretical risk of transmitting new variant CJD from transfusions based on donor exposure to BSE in the UK? (result 12 x yes, 9 x no)
1(b): If the answer to the previous question is yes, what should the deferral criteria be? (1 for greater 3 years, 5 for greater than 1 year, 7 for greater than 6 months, 4 for greater than 4 months, and one abstention. Median is 6 months UK residence between 1980 and 1996 = 80% risk reduction for 2.2% reduction in blood supply)
2(a): Should FDA recommend new deferral criteria for donors to pool products, to attempt to reduce the theoretical risk of transmitting new variant CJD from transfusions based on donor exposure to BSE in the UK? (result 12 x yes, 8 x no, 1 abstention)
2(b): If the answer to the previous question is yes, what should the deferral criteria be? (Unanimous for the same as 1(b))
Meeting Details
Attendees
Opening
        Paul Brown, M.D., Committee Chair
Administrative Remarks
        William Freas, Ph.D., Executive Secretary, SEAC, FDA
Introductory Remarks
        Randolph Wykoff, M.D., Associate Commissioner for Operations, FDA
Deferral of Blood Donors
        Based Upon Foodborne Exposure to BSE Agent: Donor Survey Results,
        Time Course Of The BSE Epidemic And Its Relationship To nvCJD,
        Risk Estimates, And Reserve Capacity Of The U.S. Blood Supply
              Mary Elizabeth Jacobs, Ph.D.
              Office of Blood Research and Review, CBER, FDA
Result of Survey of U.S. Blood Donors
       Conductedby the American Red Cross, American Association
       of Blood Banks, America's Blood Centers, and
       the National Heart, Lung, and Blood Institute
              Alan Williams, Ph.D.
              American Red Cross, Holland Laboratories
              Rockville, Maryland
Demographics of BSE
       U.K. RegulatoryDecisions, and Time Course of nvCJD
              Christl Donnelly, Sc.D.
              Head, Statistics Unit
              Welcome Trust Centre for the Epidemiology of
              Infectious Diseases
              University of Oxford, U.K.
Det Norsk Veritas Risk Assessment
              Philip Comer
              Director of Client Services
              Det Norsk Veritas, U.K.
Reserve Capacity of the U.S. Blood Supply:
       Summary of the April 29-30, 1999 Meeting of the
       Advisory Committee on Blood Safety and Availability
              Stephen D. Nightingale, M.D.,
              Executive Secretary
              Advisory Committee on Blood Safety and Availability
Canadian National Blood Safety Council Open Forum 
              Penny Chan, Ph.D., MHSc.
              Scientific Secretariat
              National Blood Safety Council
              Canada
Open Public Hearing
              Rutherford
                     Medical Service Corps, U S Navy, Director Armed Services Blood
                     program
              Gregory
                     The American Association of Blood Banks
              Cavenaugh
                     Committee of Ten Thousand
              Busch
                     Scientific Director, Blood Centers of the Pacific
              Davey
                     Chief Medical Officer, American Red Cross
              McMillan
                     National Blood Data Resource Center
              Sullivan
                     National Blood Data Resource Center
Committee Discussion and Vote
              All Participants
Operational Definition of Possible nvCJD Case for Quarantine of Blood and Blood Products
              Dorothy Scott, M.D., Division of Hematology,
              Office of Blood Research and Review, FDA