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September 14-15, 2000 Meeting
Date and Time
The meeting will be held on September 14, 2000 from 8:00 am until 5:00 pm; and on September 15, 2000 from 8:00 am until 4:00 pm.
Location
Gaithersburg Hilton, 620 Perry Parkway, Gaithersburg, MD 20877, 301-977-8900.
Contact Person
Linda A. Smallwood, Ph.D. 301-827-3514, or FDA Advisory Committee Information Line, 1-800-741-8138 (301-443-0572 in the Washington, DC area), code 19516. Please call the Information Line for up-to-date information on this meeting.
Agenda
On September 14, 2000, the following committee updates are tentatively scheduled: summary of the Public Health Service (PHS) Advisory Committee on Blood Safety and Availability meeting, hepatitis C virus lookback, factor VIII and von Willebrand factor standards, shortage issues (blood components and recombinant factor VIII). In the morning, the committee will hear presentations, discuss and make recommendations on HIV p24 antigen testing of plasma for fractionation: potential criteria for discontinuation. In the afternoon, the committee will hear presentations, discuss and make recommendations on deferral, as blood or plasma donors, of males who have had sex with males.
On September 15, 2000, the following updates are tentatively scheduled: summaries of recent meetings and workshops on 1) recruiting blood donors: successful practices; 2) cord blood; 3) tissue meeting on bone products; and 4) the joint meeting of the Transmissible Spongiform Encephalopathies and the Vaccines and Related Biological Products Advisory Committees. In the morning, the committee will hear presentations, discuss and make recommendations on the current utility of screening blood donors for syphilis. In the afternoon, the committee will sit as a medical device panel for the classification of human leukocyte antigens (HLA) devices, and will hear the report of the intramural site visit of the Laboratory of Molecular Virology, Division of Emerging and Transfusion Transmitted Diseases, Office of Blood Research and Review.
Oral Presentations
On September 14, 2000, from approximately 9:30 to 11:45 am and 3:30 to 4:00 pm; and on September 15, 2000, from approximately 11:00 to 11:30 am and 1:45 to 2:15 pm oral presentations from the public will be scheduled. Those desiring to make formal oral presentations should notify the contact person before August 28, 2000.
Closed Committee Deliberations
On September 15, 2000, from 3:30 until 4:00 pm the meeting will be closed to permit discussion where disclosure would constitute a clearly unwarranted invasion of personal privacy (5 U.S.C. 552b (c) (6)).
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