Transmissible Spongiform Encephalopathies Advisory Committee
June 2-3, 1999 Meeting
Date and Time
The meeting will be held on June 2, 1999, 8:30 am to 5:30 pm and June 3, 1999, 8:30 am to 4:00 pm.
Location
Holiday Inn-Gaithersburg, Ballroom, 2 Montgomery Village Avenue, Gaithersburg, MD 20879. 20879, 301-948-8900.
Contact Person
William Freas or Sheila D. Langford, (301) 827-0314, or FDA Advisory Committee Information Line, 1-800-741-8138 (301-443-0572 in the Washington, DC area) code 12392. Please call the Information Line for up-to-date information on this meeting.
Agenda
On June 2, 1999, the committee will continue the discussion from its December 18, 1998, meeting on the possible deferral of blood or blood product donors based on geographical criteria linked to possible food-borne exposure to the agent of Bovine Spongiform Encephalopathy as a measure to reduce the potential for transmission of new variant Creutzfeldt-Jakob Disease (nvCJD). The potential effects of such deferrals on the supply of blood and blood products will be considered as part of the committee's deliberations. The results of a survey of blood donors for duration and time periods of their visits to U.K. countries are expected to be presented. On June 3, 1999, the committee will receive an update on dura mater allograft materials. The committee will then discuss precautions needed to assure safe sources of sheep-derived and goat-derived materials contained in or used to manufacture injectable or implantable FDA-regulated products.
Oral Presentations
Between approximately 1:45 to 2:45 pm on June 2, 1999, and 1:00 to 1:30 pm on June 3, 1999 oral presentations from the public will be scheduled. Those desiring to make formal oral presentations should notify the contact person before May 26, 1999.
Closed Committee Delibrations
On June 3, 1999, from 3:45 to 4:00 pm the meeting will be closed to permit discussion and review of trade secret and/or confidential information (5 U.S.C. 552b(c)(4)).
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