[Federal Register Volume 62, Number 78 (Wednesday, April 23, 1997)]
[Notices]
[Page 19767]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-10479]


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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 the Committee: Dental Drug Products Panel Plaque 
Subcommittee (Nonprescription Drugs) of the Medical Devices Advisory 
Committee, code 12518.
    General Function of the Committee: The committee reviews and 
evaluates data on the safety and effectiveness of marketed and 
investigational devices and makes recommendations for their regulation. 
The Dental Products Panel of the Medical Devices Advisory Committee 
functions at times as a nonprescription drugs advisory panel. As such, 
the committee reviews and evaluates available data concerning the 
safety and effectiveness of active ingredients, and combinations 
thereof, of various currently marketed nonprescription drug products 
for human use, the adequacy of their labeling, and advises the 
Commissioner of Food and Drugs on the issuance of monographs 
establishing conditions under which these drugs are generally 
recognized as safe and effective and not misbranded.
    Date and Time: The meeting will be held on May 8 and 9, 1997, 8:30 
a.m. to 5 p.m. Open public hearing portions are scheduled from 8:30 
a.m. to 12 m. on May 8, 1997, and from 8:30 a.m. to 12 m. on May 9, 
1997.
    Location: Ramada Inn--Bethesda, Ambassador Ballroom, 8400 Wisconsin 
Ave., Bethesda, MD.
    Contact Person: Andrea G. Neal or LaNise S. Giles, 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 12518. Please call the Information Line for 
up-to-date information on this meeting.
    Agenda: On May 8, 1997, the subcommittee will discuss the safety of 
the individual ingredients menthol, thymol, methyl salicylate, and 
eucalyptol, and continue its discussion of the effectiveness of these 
ingredients. The subcommittee will also discuss zinc citrate. In 
addition, there will be continued discussion and/or summaries and 
voting on the ingredients cetylpyridinium chloride, Microdent, sodium 
lauryl sulfate, and C31G-Therasol .
    On May 9, 1997, the subcommittee will discuss the safety and 
effectiveness of the combination of hydrogen peroxide and povidone 
iodine, and the effectiveness of the combination of hydrogen peroxide, 
sodium citrate, zinc chloride, and sodium lauryl sulfate. There will 
also be continued discussion and/or summaries and voting on the 
ingredients xylitol, sodium bicarbonate, and the combination of 
hydrogen peroxide and sodium bicarbonate. In addition, the subcommittee 
will discuss general recommendations for antiplaque combination 
ingredients.
    Procedure: The meeting is open to the public. 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 April 30, 1997. Those desiring to make formal 
presentations should notify the contact person before April 30, 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.
    FDA regrets that it was unable to publish this notice 15 days prior 
to the May 8 and 9, 1997, Dental Drug Products Panel Plaque 
Subcommittee (Nonprescription Drugs) of the Medical Devices Advisory 
Committee meeting. Because the agency believes there is some urgency to 
bring this issue to public discussion and qualified members of the 
Dental Drug Products Panel Plaque Subcommittee (Nonprescription Drugs) 
of the Medical Devices Advisory Committee were available at this time, 
the Commissioner concluded that it was in the public interest to hold 
this meeting even if there was not sufficient time for the customary 
15-day public notice.
    Notice of this meeting is given under the Federal Advisory 
Committee Act (5 U.S.C. app. 2).

    Dated: April 17, 1997.
Michael A. Friedman,
Deputy Commissioner for Operations.
[FR Doc. 97-10479 Filed 4-22-97; 8:45 am]
BILLING CODE 4160-01-F