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Allergenic Products Advisory Committee

Center Date Time Location
CBER April 7, 2005 8:30 a.m. - 4 p.m.

Holiday Inn Select
8120 Wisconsin Ave.
Bethesda, MD

Agenda:
The Committee will discuss a proposed strategy for the reclassification of Class IIIA allergenic products. The Committee will also receive an update of the FDA Critical Path Initiative.

Background material and meeting information will become available no later than one business day before the meeting (Simply select the appropriate committee link).

Procedure:
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 March 31, 2005. Oral presentations from the public will be scheduled between approximately 11:15 a.m. and 12:15 p.m.. Time allotted for each presentation may be limited. Those desiring to make formal oral presentations should notify the contact person before March 31, 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 Gail Dapolito at least 7 days in advance of the meeting.

Contact Person:
Gail Dapolito or Jane Brown, Center for Biologics Evaluation and Research (HFM-71), Food and Drug Administration, 1401 Rockville Pike, 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 3014512388. Please call the Information Line for up-to-date information on this meeting.

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