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September 18, 2003 Meeting
Date and Time:
The meeting will be held on September 18, 2003, 8:00 a.m. to 6:00 p.m.
Location:
Gaithersburg Hilton Hotel, 620 Perry Parkway, Gaithersburg, MD, 301-977-8900.
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 19516. Please call the Information Line for up-to-date information on this meeting.
Agenda:
The following committee updates are tentatively scheduled: 1) announcement of appointment of the new Director, Division of Hematology, Office of Blood Research and Review; 2) summary of Public Health Service Advisory Committee on Blood Safety and Availability; 3) summary of National Heart, Lung and Blood Institute (NHLBI) workshop on pathogen reduction and blood component safety; 4) approval of human immune deficiency virus, type 1 (HIV-1) group "O" senstitive assays; 5) revised guidance on Severe Acute Respiratory Syndrome (SARS); 6) updated donor travel survey; and 7) labeling and storage: blood and blood components (proposed regulation). In the morning, the committee will also hear informational presentations on: 1) an overview of counterterrorism exercise; and 2) the current status of West Nile Virus (WNV) safety. In the afternoon, the committee will hear presentations, discuss and provide recommendations on the topic of supplemental testing for HIV-1 and hepatitis C virus (HCV).
Oral Presentations:
Between approximately 10:00 and 10:15 a.m.; 11:30 a.m. and 12:30 p.m.; and 4:15 and 4:45 p.m. oral presentations from the public will be scheduled. Those desiring to make formal oral presentations should notify the contact person before September 8, 2003.
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