Some FDA Advisory Committee meetings (FWIW)
Scientific Advisors and Consultants Staff June 2000 Advisory Committee Meetings
Transmissible Spongiform Encephalopathies Advisory Committee
Date and Time: The meeting will be held on June 1, 2000, from 8:30am to 5:30pm and on June 2, 2000, from 8:30am to 3:30pm.
Location: Holiday Inn-Gaithersburg, Ballroom, 2 Montgomery Village Avenue, Gaithersburg, MD. 20879, 301-948-8900.
Contact Person: William Freas or Sheila D. Langford, 301-827-0314. Please call the Information Line for up-to-date information on this meeting.
Agenda: On June 1, 2000, the committee will discuss policies for deferral of blood and plasma donors because of their possible exposure to the agent of bovine spongiform encephalopathy (BSE). On June 2, 2000, the committee will discuss the scientific merit of leukoreduction as a method to reduce the theoretical risk of Creutzfeldt-Jakob Disease (CJD) and/or new variant CJD (nvCJD) in blood and blood components for transfusions as well as plasma for manufacture into derivatives. In the afternoon the committee will receive an update on the regulatory status of human dura mater.
Oral Presentations: On June 1, 2000, between approximately 1:30 - 2:00pm and 3:10 to 3:25pm, and on June 2, 2000, between approximately 10:45 to 11:15am and 1:45 to 2:00pm oral presentations from the public will be scheduled. Those desiring to make formal oral presentations should notify the contact person before May 22, 2000.
Closed Committee Deliberations: : On June 1, 2000, from 5:15 to 5:30pm the meeting will be closed to permit discussion and review of trade secret and/or confidential information (5 U.S.C. 552b (c) (4)).
Blood Products Advisory Committee
Date and Time: The meeting will be held on June 15, 2000, from 8:00am to 5:00pm, and on June 16, 2000, from 9:00am to 12:30pm.
Location: Holiday Inn, 8777 Georgia Avenue, Silver Spring, MD. 20910, 301-563-3721.
Contact Person: Linda A. Smallwood, Ph.D., 301-827-3514. Please call the Information Line for up-to-date information on this meeting.
Agenda: On June 15, 2000, the committee will hear updates on summaries of the PHS Advisory Committee on Blood Safety and Availability meeting held April 25-26, 2000; the FDA Transmissible Spongiform Encephalopathies Advisory Committee meeting held June 1-2, 2000; the FDA sponsored workshop on plasticizers held on October 18, 1999, and a briefing on blood supply monitoring. The committee will also hear presentations and provide recommendations on plasma pool screening by nucleic acid tests for Hepatitis A virus and, in the afternoon, hear presentations and provide recommendations on the development of rapid HIV tests. On June 16, 2000, the committee will hear updates on requirements for syphilis testing; the risk of Hepatitis C virus to sexual partners; relative sensitivity of Hepatitis B surface antigen and Hepatitis B virus nucleic acid tests; and hear and discuss presentations on proposed FDA guidance on universal leukoreduction: current thinking.
Oral Presentations: Between approximately 11:00 to 11:30am and 2:30 to 3:30pm on June 15, 2000, and between approximately 10:30 to 11:30am on June 16, 2000, oral presentations from the public will be scheduled. Those desiring to make formal oral presentations should notify the contact person by June 9,2000. |
