E6-14295. Allergenic Products Advisory Committee; Notice of Meeting

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice.

This notice announces a forthcoming meeting of a public advisory committee of the Food and Drug Administration (FDA). At least one portion of the meeting will be closed to the public.

Name of Committee: Allergenic Products Advisory Committee.

General Function of the Committee: To provide advice and recommendations to the agency on FDA's regulatory issues.

Date and Time: The meeting will be held on September 13, 2006 from 12 noon to approximately 3:45 p.m.

Location: National Institutes of Health, Bldg. 29B, Conference Rooms A and B, Bethesda, MD.

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.

Agenda: On September 13, 2006, the committee will discuss a proposed strategy for the reclassification of Category IIIA allergenic products. The committee will also receive an update of the research program of the Laboratory of Immunobiochemistry, Division of Bacterial, Parasitic and Allergenic Products, Center for Biologics Evaluation and Research.

Procedure: On September 13, 2006, from 12 noon to approximately 3:15 pm, 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 on or before September 6, 2006. Oral presentations from the public will be scheduled between approximately 1:45 pm and 2:45 pm. Time allotted for each presentation may be limited. Those desiring to make formal oral presentations should notify the contact person 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 on or before September 6, 2006.

Closed Committee Deliberations: On September 13, 2006 from approximately 3:15 pm to 3:45 p.m., 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)). The committee will discuss individual research programs in the Office of Vaccines Research and Review.

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.

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

Dated: August 23, 2006.

Randall W. Lutter,

Associate Commissioner for Policy and Planning.