|
March 16-17, 2000 Meeting
Date and Time
The meeting will be held on March 16, 2000, 8:00 am to 6:00 pm; and on March 17, 2000, 8:00 am - 3:30 pm.
Location
Holiday Inn, Kennedy Grand Ballroom, 8777 Georgia Avenue, Silver Spring, MD 20910, 301-589-0800.
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 March 16, the following Committee updates are tentatively scheduled: summaries of recent workshops on bacterial contamination of platelets, criteria for safety and efficacy evaluation of oxygen therapeutics as red cell
substitutes, implementation of universal leukoreduction, and the NIH workshop on parvovirus B19. In the morning, the committee will hear presentations, discuss and make recommendations on a submitted proposal to revise the
interpretation of indeterminate HIV-1 Western Blots with only non-viral bands. In the afternoon, the committee will hear presentations, discuss and make recommendations on the topics of a history of hepatitis in blood and plasma donors and hepatitis B virus (HBV) nucleic acid testing. On March 17, the committee will hear updates on the following topics: summary of the January 2000 PHS advisory committee meeting on Blood Safety and Availability, CJD policy, HCV lookback guidance, post donation information algorithm, and IGIV clinical endpoints. In the morning, the committee will hear an informational
presentation on the blood action plan: supply issues, and will discuss and make recommendations on donor deferral issues related to xenotransplantation. In the afternoon, the committee will be briefed on research programs in the Laboratory
of Plasma Derivatives, Division of Hematology. The committee will also deliberate in closed session.
Oral Presentations
On March 16, between approximately 10:30 and 11:00 am, 2:30 and 3:00 pm, and 4:30 and 5:00 pm; and on March 17, between approximately 9:30 and 10:00 am, and 11:30 am and 12:00 noon oral presentations from the public will be scheduled. Those desiring to make formal oral presentations should notify the contact person before March 7.
Closed Committee Deliberations
On March 17, from 3:00 to 3:30 pm the meeting will be closed to permit discussion where disclosure would constitute a clearly unwarranted invasion of personal privacy (5 U.S.C. 552b(c)(6)).
|
