[Federal Register Volume 62, Number 157 (Thursday, August 14, 1997)]
[Notices]
[Page 43539]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-21571]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Advisory Committee; Notice of Meeting
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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This notice announces a forthcoming meeting of public advisory
committees of the Food and Drug Administration (FDA). The meeting will
be open to the public.
Name of Committees: Joint meeting of the Nonprescription Drugs
Advisory Committee and Pulmonary-Allergy Drugs Advisory Committee.
General Function of the Committees: To provide advice and
recommendations to the agency on FDA regulatory issues.
Date and Time: The meeting will be held on September 19, 1997,
8:30 a.m. to 5 p.m.
Location: Holiday Inn, Ballroom, Two Montgomery Village Ave.,
Gaithersburg, MD.
Contact Person: Andrea G. Neal or Leander B. Madoo, Center for
Drug Evaluation and Research (HFD-21), Food and Drug Administration,
5600 Fishers Lane, Rockville, MD 20857, 301-443-5455, or FDA Advisory
Committee Information Line, 1-800-741-8138 (301-443-0572 in the
Washington, DC area), codes 12541 and 12545. Please call the
Information Line for up-to-date information on this meeting.
Agenda: The committees will jointly consider new drug application
(NDA) 20-840, Beconase Allergy Nasal Spray (belcomethasone
dipropionate 0.042%, monohydrate, Glaxo Wellcome, Inc.) for over-the-
counter treatment and prevention of the symptoms of seasonal allergic
rhinitis in patients 12 years of age and older.
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 September 5,
1997. Oral presentations from the public will be scheduled between
approximately 8:30 a.m. to 9:30 a.m. Time allotted for each
presentation may be limited. Those desiring to make formal oral
presentations should notify the contact person before September 5,
1997, 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 7, 1997.
William B. Schultz,
Acting Lead Deputy Commissioner for the Food and Drug Administration.
[FR Doc. 97-21571 Filed 8-13-97; 8:45 am]
BILLING CODE 4160-01-F
