[Federal Register Volume 65, Number 169 (Wednesday, August 30, 2000)]
[Page 52775]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-22141]



Food and Drug Administration

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

    Dated: August 21, 2000.
Linda A. Suydam,
Senior Associate Commissioner.
[FR Doc. 00-22141 Filed 8-29-00; 8:45 am]