04-5405. 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). The meeting will be open 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 via teleconference on April 2, 2004, from 1 p.m. to 3:40 p.m.

Location: Food and Drug Administration, Bldg. 29B, Conference Rooms A & B, 8800 Rockville Pike, Bethesda, MD. This meeting will be held by teleconference. The public is welcome to attend the meeting at the above location. A speaker phone will be provided at the specified location for public participation in this meeting.

Contact Person: William Freas 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 April 2, 2004, the committee will hear updates on the following topics: Personnel organization, research and regulatory work of the Laboratory of Immunobiochemistry in the Division of Bacterial, Parasitic and Allergenic Products, Center for Biologics and an update on FDA activities relating to cockroach standardization. The committee will then discuss use of microarray technology in allergen standardization.

Procedure: On April 2, 2004, from 1 p.m. to 3:40 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 March 25, 2004. Oral presentations from the public will be scheduled between approximately 2:40 p.m. and 3:40 p.m. Time allotted for each presentation may be limited. Those desiring to make formal oral presentations should notify the contact person before March 29, 2004, 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 Jane Brown 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: March 4, 2004.

William K. Hubbard,

Associate Commissioner for Policy and Planning.