[Federal Register: August 27, 1998 (Volume 63, Number 166)] [Notices] [Page 45825] From the Federal Register Online via GPO Access [wais.access.gpo.gov] [DOCID:fr27au98-104] ----------------------------------------------------------------------- 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. ----------------------------------------------------------------------- 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for OTC vaginal antifungal drug products in accordance with the February 27, 1997, proposed rule and the agency's draft guidance document for industry entitled ``Class Labeling of OTC Topical Drug Products for the Treatment of Vaginal Yeast Infections (Vulvovaginal Candidiasis)'' and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 The draft guidance document is intended to provide guidance for both the carton and educational brochure.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