Blood Products Advisory Committee
September 10-11, 2008
Date and Time:
The meeting will be held on September 10, 2008 from 8:00 a.m. to 5:45 p.m. and on September 11, 2008 from 8:00 a.m. to 3:00 p.m.
Location:
Hilton Hotel, Washington, D.C./Rockville Executive Meeting Center, 1750 Rockville Pike, Rockville, MD 20852.
Contact Person:
Donald W. Jehn or Pearline K. Muckelvene, Center for Biologics Evaluation and Research (CBER), Food and Drug Administration, 1401 Rockville Pike, HFM-71, Rockville, MD 20852, 301-827-0314, or FDA Advisory Committee Information Line, 1-800-741-8138 (301-443-0572 in the Washington, DC area), code 3014519516. Please call the Information Line for up-to-date information on this meeting.
Agenda:
On the morning of September 10, 2008, the Committee will hear an update on the May 29-30, 2008 meeting of the DHHS Advisory Committee on Blood Safety and Availability. Following this update, the Committee will discuss strategies to enhance bacterial safety of seven day platelets for transfusion. In the afternoon, the Committee will discuss iron status in blood donors. On September 11, 2008, the Committee will hear updates on the following topics: (1) April 29-30, 2008 workshop on hemoglobin based oxygen carriers; (2) July 10-11, 2008 blood establishment computer software conference; (3) the development of an automated Biologics License Application submission system; and (4) Draft Guidance for Industry: Re-qualification Method for Re-entry of Blood Donors Deferred Because of Reactive Test Results for Antibody to Hepatitis B Core Antigen (Anti-HBc). Following these updates, the Committee will discuss options for blood donor screening and re-entry for malaria.
Oral Presentations:
Oral presentations from the public will be scheduled between approximately 10:45 a.m. and 11:30 a.m. and between approximately 4:00 p.m. and 4:30 p.m. on September 10, 2008 and between approximately 9:15 a.m. and 9:45 a.m. and between approximately 1:30 p.m. and 2:00 p.m. on September 11, 2008. Time allotted for each presentation may be limited. Those desiring to make formal oral presentations should notify the contact person before August 22, 2008.