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October 21 - 22, 2004 Meeting
Date and Time:
The meeting will be held on October 21, 2004, 8:00 a.m. to 5:30 p.m., and on October 22, 2004, 8:30 a.m. to 12:45 p.m.
Location:
Holiday Inn Gaithersburg, 2 Montgomery Village Avenue, Gaithersburg, MD 20877, 301-948-8900
Contact Persons:
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 3014519516. Please call the Information Line for up-to-date information on this meeting.
Agenda:
On October 21, 2004, the Committee will hear updates on: Summary of the Transmissible Spongiform Encephalopathies Advisory Committee (TSEAC) meeting discussion of new variant Creutzfeldt-Jacob disease (vCJD) transmission by transfusion in the United Kingdom and supplemental testing for human immunodeficiency virus (HIV) and hepatitis C virus (HCV). In the morning, the Committee will also discuss and provide recommendations on the agency's current thinking on re-entry of donors previously deferred for anti-HBc reactivity. In the afternoon, the Committee will discuss and provide recommendations on the potential risk of transmission of Simian Foamy Virus (SFV) by blood transfusions. On October 22, 2004, the Committee will hear updates on: a summary of the Plasma Workshop held on August 31-September 1, 2004, draft uniform donor health questionnaire acceptance guidance: review of public comments, and FDA current thinking on monitoring weight in source plasma donors. The Committee will also hear presentations, discuss and provide recommendations on the agency's current thinking on donor deferral for potential or documented infection with West Nile Virus (WNV).
Oral Presentations:
Between approximately 10:30 and 11:00 a.m., 4:00 and 4:30 p.m. on October 21; and 11:00 and 11:45 a.m. on October 22, 2004, oral presentations from the public will be scheduled. Those desiring to make formal oral presentations should notify the contact person before October 8, 2004.
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