Joint Meeting of the Nonprescription Drugs Advisory Committee and the Pulmonary-Allergy Drugs 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 Committees: Nonprescription Drugs Advisory Committee and the Pulmonary-Allergy Drugs Advisory Committee.

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

Date and Time: The meeting will be held on May 11, 2001, 8 a.m. to 5 p.m.

Location: Holiday Inn, Two Montgomery Village Ave., Gaithersburg, MD.

Contact: Sandra L. Titus or Kimberly L. Topper, Center for Drug Evaluation and Research (HFD-21), Food and Drug Administration, 5600 Fishers Lane, (for express delivery, 5630 Fishers Lane, rm. 1093) Rockville, MD 20857, 301-827-7001, or e-mail: Tituss@cder.fda.gov, or FDA Advisory Committee Information Line, 1-800-741-8138 (301-443-0572 in the Washington, DC area), codes 12541 and 12545. Please call the Information Line for up-to-date information on this meeting.

Agenda: The committees will consider citizen petition 98P-0610/CP1, submitted by Blue Cross of California, that requested the agency to convert fexofenadine hydrochloride, loratadine, and cetirizine hydrocholoride to over-the-counter (OTC) status.

Background material, including the petition to switch the antihistamines to OTC status, is available at http://www.fda.gov/ohrms/dockets/ac/acmenu.htm. Click on the year 2001 and go to the May 11th Nonprescription Drugs Advisory Committee file.

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 May 2, 2001. Oral presentations from the public will be scheduled between approximately 9 a.m. and 9:30 a.m. and between approximately 1 p.m. and 1:30 p.m. Time allotted for each presentation may be limited. Those desiring to make formal oral presentations should notify the contact person before May 2, 2001, 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.

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