Nonprescription 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 Committee: Nonprescription Drugs 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 October 19, 2000, 8 a.m. to 5 p.m.

Location: Holiday Inn, The Ballroom, Two Montgomery Ave., Gaithersburg, MD.

Contact Person: Sandra L. Titus, 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), code 12541. Please call the Information Line for up-to-date information on this meeting.

Agenda: The committee will consider safety issues regarding the use of Phenylpropanolamine (PPA) in over-the-counter (OTC) drug products. The discussion will focus on the reported results of an epidemiological study designed to assess the risk of hemorrhagic stroke associated with the use of PPA. The Consumer Health Products Association (CHPA) commissioned the study which was conducted by Yale University. The material which the committee will review will be available at least 1 business day before the meeting at: http://www.fda.gov/ohrms/dockets/ac/acmenu.htm. Click on the year 2000 and then locate the Nonprescription Drugs Advisory Committee meeting for October 20, 2000.

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 October 9, 2000. Oral presentations from the public will be scheduled between approximately 1 p.m. and 2 p.m. Time allotted for each presentation may be limited. Those desiring to make formal oral presentations should notify the contact person before October 9, 2000, 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).