[Federal Register Volume 65, Number 169 (Wednesday, August 30, 2000)]
[Notices]
[Pages 52775-52776]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-22144]


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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; Notice of Meeting

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 Committees: To provide advice and

[[Page 52776]]

recommendations to the agency on FDA's regulatory issues.
    Date and Time: The meeting will be held on October 20, 2000, 8 a.m. 
to 5 p.m.
    Location: Holiday Inn, The Ballroom, Two Montgomery Ave., 
Gaithersburg, MD.
    Contact Person: Sandra L. Titus or Thomas H. Perez, 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: [email protected], 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 new drug application (NDA) 21-
229 proposing over-the-counter (OTC) use of Prilosec 
(omeprazole), Astra-Zeneca with distribution by Procter and Gamble. 
This is proposed to: (1) Relieve heartburn, acid indigestion and sour 
stomach, and (2) prevent heartburn, acid indigestion, and sour stomach 
brought on by consuming food and beverages, or associated with events 
such as stress, hectic lifestyle, lying down, or exercise.
    The background material that the committees will review will be 
available 1 business day before the meeting on the Internet 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. to 2 p.m. on October 20, 2000. 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).

    Dated: August 21, 2000.
Linda A. Suydam,
Senior Associate Commissioner.
[FR Doc. 00-22144 Filed 8-29-00; 8:45 am]
BILLING CODE 4160-01-F