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Meeting of the Blood Products Advisory Committee

Center Date Time Location
CBER September 10, 2008
September 11, 2008
8:00 a.m. - 5:45 p.m.
8:00 a.m. - 3:00 p.m.
Hilton Hotel, Washington, DC
Rockville Executive Meeting Center
1750 Rockville Pike
Rockville, MD


On the morning of September 10, 2008, the Committee will hear an update on the May 29 to 30, 2008, meeting of the Department of Health and Human Services Advisory Committee on Blood Safety and Availability. Following this update, the Committee will discuss strategies to enhance bacterial safety of 7 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 to 30, 2008, workshop on hemoglobin based oxygen carriers; (2) July 10 to 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software conference; (3) the development of an automated Biologics License Application submission system; and (4) Draft Guidance for Industry: Re-qualification Method for Re-entry of Blood Donors Deferred Because of Reactive Test Results for Antibody to Hepatitis B Core Antigen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.

Meeting Materials

Meeting Materials

Public Participation Information

Interested persons may present data, information, or views, orally or in writing, on issues pending before the committee.

Time allotted for each presentation may be limited. If the number of registrants requesting to speak is greater than can be reasonably accommodated during the scheduled open public hearing session, FDA may conduct a lottery to determine the speakers for the scheduled open public hearing session. The contact person will notify interested persons regarding their request to speak by August 25, 2008.

Contact Information

FDA intends to make background material available to the public no later than 2 business days before the meeting. If FDA is unable to post the background material on its Web site prior to the meeting, the background material will be made publicly available at the location of the advisory committee meeting, and the background material will be posted on FDA's Web site after the meeting.

Persons attending FDA's advisory committee meetings are advised that the agency is not responsible for providing access to electrical outlets. FDA welcomes the attendance of the public at its advisory committee meetings and will make every effort to accommodate persons with physical disabilities or special needs. If you require special accommodations due to a disability, please contact Donald W. Jehn or Pearline K. Muckelvene at least 7 days in advance of the meeting. FDA is committed to the orderly conduct of its advisory committee meetings. Please visit our Web site at http://www.fda.gov/oc/advisory/ for procedures on public conduct during advisory committee meetings.

Notice of this meeting is given under the Federal Advisory Committee Act (5 U.S.C. app. 2).

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