[Federal Register Volume 63, Number 166 (Thursday, August 27, 1998)]
[Notices]
[Page 45825]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-23025]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration


Nonprescription Drugs 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 with 
representation from the Anti-Infective Drugs and Reproductive Health 
Drugs Advisory Committees.
    General Function of the Committee: To provide advice and 
recommendations to the agency on FDA's regulatory issues.
    Date and Time: The meeting will be held on September 11, 1998, 8:30 
a.m. to 5 p.m.
    Location: Holiday Inn-Bethesda, Versailles Ballrooms I and II, 8120 
Wisconsin Ave., Bethesda, MD.
    Contact Person: Rhonda W. Stover or Angie Whitacre, Center for Drug 
Evaluation and Research (HFD-21), Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20857, 301-827-7001, 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 with representation from the Anti-Infective 
and Reproductive Health Drugs Advisory Committees will discuss class 
labeling for over-the-counter (OTC) vaginal antifungal drug products. 
In the Federal Register of February 27, 1997 (62 FR 9024), the agency 
published a proposed rule intended to enable consumers to better read 
and understand OTC drug product labeling and to better apply this 
information in the labeling to the safe and effective use of such 
products. An important element of FDA's proposed rule is a standardized 
labeling format for OTC drug products. The agency has developed class 
labeling for OTC vaginal antifungal drug products in accordance with 
the February 27, 1997, proposed rule and the agency's draft guidance 
document for industry entitled ``Class Labeling of OTC Topical Drug 
Products for the Treatment of Vaginal Yeast Infections (Vulvovaginal 
Candidiasis)'' and other related issues. The draft guidance document is 
intended to provide guidance for both the carton and educational 
brochure. Single copies of the guidance document can be obtained by 
contacting the Drug Information Branch, Division of Communications 
Management (HFD-210), 5600 Fishers Lane, Rockville, MD 20857, 301-827-
4573 or the Internet ``http://www.fda.gov/cder/guidance/index.htm''.
    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 4, 
1998. 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 4, 1998, 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 20, 1998.
Sharon Smith-Holston,
Acting Commissioner of Food and Drugs.
[FR Doc. 98-23025 Filed 8-26-98; 8:45 am]
BILLING CODE 4160-01-F