[Federal Register: May 7, 2002 (Volume 67, Number 88)]
[Page 30718]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]



Food and Drug Administration

Joint Meeting of the Nonprescription Drugs Advisory Committee and 
the Gastrointestinal Drugs Advisory Committee

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 Gastrointestinal 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 June 21, 2002, from 8 
a.m. to 4:30 p.m.
    Location: Holiday Inn, Versailles Ballroom, 8120 Wisconsin Ave., 
Bethesda, MD.
    Contact Person: Sandra 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 committees will consider the safety and efficacy of new 
drug application (NDA) 21-229, proposing over-the-counter (OTC) use of 
PRILOSEC1 (omeprazole magnesium), AstraZeneca LP/Procter and Gamble, 
for the prevention of the symptoms of frequent heartburn. The sponsor 
proposes a 20 milligram dose to be taken for 14 days. The background 
material for this meeting will be posted one working day before the 
meeting under the Nonprescription Drugs Advisory Committee (NDAC) on 
the Dockets Management Branch Web site at http://www.fda.gov/ohrms/
dockets/ac/acmenu.htm. (Click on the year 2002 and scroll down to 
    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 June 12, 2002. 
Oral presentations from the public will be scheduled on June 21, 2002, 
between approximately 8:15 a.m. and 9:15 a.m. Time allotted for each 
presentation may be limited. Those desiring to make formal oral 
presentations should notify the contact person before June 12, 2002, 
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 
    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 Sandra Titus 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: April 29, 2002.
Linda A. Suydam,
Senior Associate Commissioner for Communications and Constituent 
[FR Doc. 02-11205 Filed 5-6-02; 8:45 am]