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September 12, 2002 Meeting
Date and Time:
The meeting will be held on September 12, 2002, 8:00 a.m. to 5:30 p.m.
Location:
Hilton Hotel, Maryland Ballroom, 8727 Colesville Road, Silver Spring, MD 20910, 301-589-5200.
Contact:
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 12, the following committee updates are tentatively scheduled: consideration of the Clinical Laboratory Improvement Act (CLIA) waivers for rapid human immunodeficiency virus tests, implementation of human immunodeficiency virus, type 1/hepatitis C virus nucleic acid testing algorithm, summary of Public Health Service Advisory Committee on Blood Safety and Availability meeting held on September 5, 2002, summary of the workshop on pathogen inactivation held on August 7-8, 2002, and blood establishment registration-electronic submissions. In the morning, the committee will hear discussion and provide recommendations on the topic of self-administration of the uniform donor history questionnaire: first time donors. In the afternoon, the committee will hear an informational presentation on testing for Chagas disease, and a presentation on window period for human immunodeficiency virus (HIV) cases and current estimates of residual risk.
Oral Presentations:
Between approximately 11:00 a.m. and 11:30 a.m.; and 3:45 p.m. and 4:30 p.m. oral presentations from the public will be scheduled. Those desiring to make formal oral presentations should notify the contact person before August 23.
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