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Date and Time: The meeting will be held on September 16, 1999 from 8:00am to 4:30pm and September 17, 1999 from 8:00am to 12:30pm.
Location: Bethesda Ramada Inn, Embassy Ballroom, 8400 Wisconsin Avenue, Bethesda, MD 20814, 301-654-1000
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 16, 1999 the following committee updates are tentatively scheduled: summary of the August 26-27,1999 meeting of the Public Health Service (PHS) advisory committee on Blood Safety and Availability; summary of the July 21, 1999 workshop on donor suitability: donor history of hepatitis; guidance document on revised precautionary measures to reduce the possible risk of transmission of Creutzfeldt-Jakob Disease (CJD) and new variant Creutzfeldt-Jakob Disease (nvCJD) by blood and blood products. Other committee updates will be scheduled if the need arises. In the morning the committee will hear and discuss an informational presentation on strategies for increasing the blood supply, and discuss and provide recommendations on nucleic acid testing of blood donors for human parvovirus B-19. In the afternoon, the committee will hear an informational presentation on antigen/antibody testing for malaria.
On September 17, 1999 the committee will sit as a medical device panel for the reclassification of Human Immunodeficiency Virus (HIV) drug sensitivity assays. At these meeting, the agency will describe the calssification of biological products, and ask the committee for a recommendation for classification of biological products, or viral resistance assays. The classification assignment determines how these assays are to be regulated by the agency.
Oral Presentations: Between approximately 10:00 to 10:30am, 11:30am to 12:00noon, and 3:00 to 3:30pm on September 16, 1999; and between 9:00 to 11:00am on September 17, 1999 oral presentations from the public will be scheduled. Those desiring to make formal oral presentations should notify the contact person before September 7, 1999.
Posted on the Web by:
Office of Special Health Issues
oshi@oc.fda.gov
Office of International and Constituent Relations
Food and Drug Administration