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September 20-21, 2001 Meeting
Date and Time
The meeting will be held on September 20-21, 2001, at 8:00 a.m. on both days.
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 20, 2001, the following committee updates are tentatively scheduled: transmissible spongiform encephalopathies (TSE) guidance, hepatitis B surface antigen lot release guidance, human immunodeficiency virus (HIV) and hepatitis C virus (HCV) nucleic acid testing, clinical laboratory improvement act (CLIA) waiver for HIV rapid tests, and compliance quality control oversight. In the morning, the committee will hear presentations, discuss and make recommendations on potential concerns for simian foamy virus (SFV) transmission by blood and blood products. In the afternoon, the committee will hear presentations, discuss and make recommendations on the leukocyte reduction guidance. On September 21, 2001, the committee will hear presentations, discuss and make recommendations on human cells, tissues and cellular and tissue-based products: risk factors for semen donation.
Oral Presentations
Between approximately 12 noon and 12:30 p.m., and 3:45 and 4:45 p.m. on September 20, 2001; and 11:30 a.m. and 1:00 p.m. on September 21, 2001, oral presentations from the public will be scheduled. Those desiring to make formal oral presentations should notify the contact person before September 4, 2001.
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