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December 11 - 12, 2003 Meeting
Date and Time:
The meeting will be held on December 11, 2003, from 8:00 a.m. to 6:30 p.m.; and on December 12, 2003, from 8:00 a.m. to 3:00 p.m.
Location:
Hilton DC North-Gaithersburg, Grand Ballrooms A,B,C, and D, 620 Perry Parkway, Gaithersburg, MD 20877, 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:
On December 11, 2003, the committee will hear presentations, discuss and provide recommendations on the following topics: the American Association for Blood Banks (AABB) Abbreviated Donor Questionnaire; and blood donor deferral for exposure to Leishmaniasis. In the afternoon, the committee will hear an update on the West Nile Virus (WNV) epidemic and donor testing in 2003, including updates on WNV testing under investigational new drug applications and plans for 2004. On December 12, 2003, the committee will hear updates on the following topics: the medical device user fee act; the use of secure E-mail; a summary of the factor VIII inhibitor workshop; platelet testing and evaluation guidance; and freezing and storage temperatures for source plasma (-25 °C and -30 °C). The committee will also hear presentations, discuss and provide recommendations on the review of plasma collection nomograms.
Oral Presentations:
Between approximately 10:30 a.m. and 11:00 a.m., 2:00 p.m. and 2:30 p.m.; and 5:30 p.m. and 5:45 p.m. on December 11, 2003; and 9:30 a.m. and 10:15 a.m., and 12:00 noon and 12:30 p.m. on December 12, 2003, oral presentations from the public will be scheduled. Those desiring to make formal oral presentations should notify the contact person before November 21, 2003.
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