[Federal Register Volume 63, Number 43 (Thursday, March 5, 1998)]
[Notices]
[Page 10919]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-5630]


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

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 regulatory issues.
    Date and Time: The meeting will be held on March 19 and 20, 1998, 
8:30 a.m. to 5:30 p.m.
    Location: Holiday Inn, Walker Room, Two Montgomery Village Ave., 
Gaithersburg, MD.
    Contact Person: Tracy Riley or Angie Whitacre, 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 12534. Please call the Information Line for 
up-to-date information on this meeting.
    Agenda: On March 19, 1998, the committee will discuss generic 
topical dermatologicals draft guidance. On March 20, 1998, the 
committee will participate in a scientific discussion of clinical trial 
design questions for products intended for the treatment of psoriasis.
    Procedure: On March 19, 1998, from 8:30 a.m. to 1 p.m., and on 
March 20, 1998, 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 should be made to the contact person by March 11, 1998. 
Oral presentations from the public will be scheduled between 
approximately 8:30 a.m. and 9 a.m., on March 19 and 20, 1998. Time 
allotted for each presentation may be limited. Those desiring to make 
formal oral presentations should notify the contact person before March 
13, 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.
    Closed Committee Deliberations: On March 19, 1998, from 1 p.m. to 
5:30 p.m., the meeting will be closed to permit discussion and review 
of trade secret and/or confidential information (5 U.S.C. 552b(c)(4)). 
This portion of the meeting will be closed to permit discussion on 
pending investigational new drug applications issues.
    Notice of this meeting is given under the Federal Advisory 
Committee Act (5 U.S.C. app. 2).

    Dated: February 25, 1998.
Michael A. Friedman,
Deputy Commissioner for Operations.
[FR Doc. 98-5630 Filed 3-4-98; 8:45 am]
BILLING CODE 4160-01-F