[Federal Register Volume 62, Number 185 (Wednesday, September 24, 1997)]
[Notices]
[Page 49988]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-25266]


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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: Dental Plaque Subcommittee Meeting of the 
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 October 29 and 30, 1997, 
8:30 a.m. to 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: On October 29, 1997, the subcommittee will continue 
discussion and/or possibly vote on the safety and effectiveness of: C-
31G, xylitol, and zinc citrate, as well as the following combination 
ingredients: (1) Menthol, thymol, eucalyptol, and methyl salicylate; 
(2) hydrogen peroxide and povidone iodine; and (3) hydrogen peroxide, 
sodium citrate, zinc chloride, and sodium lauryl sulfate. The 
subcommittee will also continue discussion of the criteria for over-
the-counter (OTC) antiplaque and antigingivitis combination drug 
products. On October 30, 1997, the subcommittee will discuss the final 
formulation testing for OTC antiplaque and antigingivitis drug 
products, and assignments will be made for the review of foreign 
marketing data supporting OTC antiplaque and antigingivitis 
ingredients.
    Procedure: Interested persons may present data, information, or 
views, orally or in writing, on issues pending before the subcommittee. 
Written submissions may be made to the contact person by October 15, 
1997. Oral presentations from the public will be scheduled on both days 
between approximately 9 a.m. and 10 a.m. Time allotted for each 
presentation may be limited. Those desiring to make formal oral 
presentations should notify the contact person before October 15, 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: September 15, 1997.
Michael A. Friedman,
Deputy Commissioner for Operations.
[FR Doc. 97-25266 Filed 9-23-97; 8:45 am]
BILLING CODE 4160-01-F