[Federal Register Volume 65, Number 111 (Thursday, June 8, 2000)]
[Notices]
[Page 36451]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-14461]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration


Dermatologic and Ophthalmic 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). At least one 
portion of the meeting will be closed to the public.
    Name of Committee: Dermatologic and Ophthalmic 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 June 29, 2000, from 8:30 
a.m. to 5:30 p.m. and on June 30, 2000, from 8:30 a.m. to 5:30 p.m.
    Location: Holiday Inn, Versailles Ballrooms I and II, 8120 
Wisconsin Ave., Bethesda, MD.
    Contact: Tracy K. Riley 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 12534. Please call the Information Line for 
up-to-date information on this meeting. Current information may also be 
accessed on the Internet at the FDA Website, www.FDA.GOV.
    Agenda: On June 29, 2000, during the initial open session, the 
committee will discuss new drug application (NDA) 20-010, 
Lotrisone<SUP>TM</SUP> Lotion (clotrimazole/betamethasone 
diproprionate), Schering-Plough, Inc., for treatment of tinea pedis, 
tinea cruris, and tinea corporis; and NDA 20-996, Dermex 
II<SUP>TM</SUP> Ointment (zinc oxinate), Dermex Pharmaceuticals, 
Limited Liability Corp., for treatment of actinic keratosis, basal cell 
carcinoma, and squamous cell carcinoma. On June 30, 2000, the committee 
will discuss NDA 21-026, (miconazole nitrate, USP 0.25%) ointment, 
Johnson & Johnson Consumer Companies, Inc., for treatment of diaper 
dermatitis.
    Procedure: On June 29, 2000, from 10 a.m. to 5:30 p.m. and on June 
30, 2000, from 8:30 a.m. to 5:30 p.m., 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 June 21, 2000. Oral 
presentations from the public will be scheduled between approximately 
10 a.m. and 10:30 a.m. on June 29, 2000, and between approximately 8:30 
a.m. and 9:30 a.m. on June 30, 2000. Time allotted for each 
presentation may be limited. Those desiring to make formal oral 
presentations should notify the contact person before June 21, 2000, 
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.
    Closed Committee Deliberations: On June 29, 2000, from 8:30 a.m. to 
10 a.m., the meeting will be closed to permit discussion and review of 
trade secret and/or confidential information regarding pending 
investigational new drug applications issues (5 U.S.C. 552b(c)(4)).
    Notice of this meeting is given under the Federal Advisory 
Committee Act (5 U.S.C. app. 2).

    Dated: May 31, 2000.
Linda A. Suydam,
Senior Associate Commissioner.
[FR Doc. 00-14461 Filed 6-7-00; 8:45 am]
BILLING CODE 4160-01-F