[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: 97-21574]


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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 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 regulatory issues.
    Date and Time: The meeting will be held on September 18, 1997, from 
8:30 a.m. to approximately 5 p.m.
    Location: Holiday Inn, The Ballroom, Two Montgomery Village Ave., 
Gaithersburg, MD.
    Contact Person: Andrea G. Neal, 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), code 12541. Please call the Information Line for up-to-date 
information on this meeting.
    Agenda: The Committee will discuss issues relating to the labeling 
and dosing of over-the-counter (OTC) pediatric analgesic/antipyretic 
drug products. The Committee will discuss topics such as: (1) What is 
an appropriate lower age limit for the dosing of OTC analgesic/
antipyretic drug products; and (2) the safety implications of the OTC 
availability of children's analgesic/antipyretic suspension products 
and double concentrated infant drops with overlapping age directions.
    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 12, 
1997. 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 September 12, 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. 97-21574 Filed 8-13-97; 8:45 am]
BILLING CODE 4160-01-F