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 |