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Research Review Subcommittee of the Blood Products Advisory Committee

Agenda:
On July 22, 2005, the subcommittee will listen to presentations to further a dynamic, responsive, and cutting edge research program in the Office of Blood Research and Review, Center for Biologics Evaluation and Research (CBER), that facilitates development of safe and effective biological products. The subcommittee’s recommendations will be publicly discussed at a future meeting of the Blood Products Advisory Committee. Information regarding CBER’s scientific program is outlined in its Strategic Plan of 2004 and is available to the public on the internet at: http://www.fda.gov/cber/inside/mission.htm. Information regarding FDA’s Critical Path to New Medical Products is available to the public on the internet at: http://www.fda.gov/oc/initiatives/criticalpath/.

Background material and meeting information will become available no later than one business day before the meeting (Simply scroll down to the appropriate committee heading).

Closed Committee Deliberations:
On July 22, 2005, from 2:15 p.m. to 5 p.m. the meeting will be closed to the public. The meeting will be closed to permit discussion where disclosure would constitute a clearly unwarranted invasion of personal privacy (5 U.S.C. 552b(c)(6)) and to permit discussion and review of trade secret and/or confidential information (5 U.S.C. 552b(c)(4)). The Committee will discuss the internal research programs in the Office of Blood Research and Review, CBER.

Procedure:
On July 22, 2005, from 8 a.m. to 1:15 p.m., the meeting is open to the public. Interested persons may present data, information, or views, orally or in writing, on issues pending before the committee. Written submissions may be made to the contact person by July 14, 2005. Oral presentations from the public will be scheduled between approximately 12:15 p.m. and 1:15 p.m. Time allotted for each presentation may be limited. Those desiring to make formal oral presentations should notify the contact person by July 14, 2005 and submit a brief statement of the general nature of the evidence or arguments they wish to present, the names and addresses of proposed participants, and an indication of the approximate time requested to make their presentation. 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 William Freas, or Pearline K. Muckelvene at least 7 days in advance of the meeting.

Contact Person:
William Freas, or Pearline K. Muckelvene, Center for Biologics Evaluation and Research, (HFM-71), Food and Drug Administration, 1401 Rockville Pike, Rockville, MD 20852, 301-827-0314.

Advisory Committee Telephone Information Line:
Please call the Information Line for up-to-date information on this meeting, 1-800-741-8138 (301-443-0572 in the Washington, DC area), code 3014519516.