[Federal Register: May 7, 2002 (Volume 67, Number 88)]
[Notices]
[Page 30718]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr07my02-69]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
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.
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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
NDAC.)
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
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 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
Relations.
[FR Doc. 02-11205 Filed 5-6-02; 8:45 am]
BILLING CODE 4160-01-S