[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