[Federal Register: June 26, 1998 (Volume 63, Number 123)]
[Notices]               
[Page 34902-34903]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr26jn98-92]

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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.
    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 July 28 and 29, 1998, 
8:30 a.m. to 5 p.m.
    Location: Holiday Inn, 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: On July 28, 1998, the committee 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. The committee will also discuss 
the agency's draft guidance document for industry entitled ``Class 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The draft guidance document is intended to provide guidance for both 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 the educational brochure. In the next several weeks 
after publication of this notice, a copy of the draft guidance

[[Page 34903]]

document for industry will be on display in the Dockets Management 
Branch (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 
1061, Rockville, MD 20852, between 9 a.m. and 4 p.m., Monday through 
Friday. A copy of the draft guidance document will also be available on 
the Internet at ``http://www.fda.gov/cder/guidance/index.htm''.
    On July 29, 1998, the committee will discuss effectiveness testing 
for final formulations of health-care antiseptic drug products relative 
to performance expectations for these OTC drug products. In the Federal 
Register of June 17, 1994 (59 FR 31402 through 31452), the agency 
published a proposed rule for OTC health-care antiseptic drug products, 
i.e., patient preoperative skin preparations, surgical hand scrubs, and 
health-care personnel and antiseptic handwashes. Included in the 
proposed rule are key characteristics for each drug product class of 
health-care antiseptic drug products (i.e., definitions), a requirement 
for final formulation testing, effectiveness standards, and labeling of 
each of the drug product categories. In response to the proposed rule, 
the agency received comments to consider six drug product categories 
(preoperative skin preparation, surgical hand scrub, health-care 
personnel handwash, food handler handwash, antimicrobial handwash, and 
antimicrobial bodywash). Comments also proposed alternate: (1) Testing 
requirements, (2) key characteristics, and (3) labeling for each of the 
categories. FDA is seeking the recommendations of the committee and 
experts on appropriate performance expectations for OTC health-care 
antiseptic drug products and how these final formulations should be 
tested.
    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 July 21, 1998. 
Oral presentations from the public will be scheduled between 
approximately 1 p.m. and 2 p.m. on July 28 and 29, 1998. Time allotted 
for each presentation may be limited. Those desiring to make formal 
oral presentations should notify the contact person before July 21, 
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: June 18, 1998.
Michael A. Friedman,
Deputy Commissioner for Operations.
[FR Doc. 98-17074 Filed 6-25-98; 8:45 am]
BILLING CODE 4160-01-F