[Federal Register Volume 63, Number 188 (Tuesday, September 29, 1998)]
[Notices]
[Pages 51941-51942]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-25906]


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

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 October 21 and 22, 1998, 
8 a.m. to 5 p.m.
    Location: Holiday Inn, Walker Room, Two Montgomery Village Ave., 
Gaithersburg, MD.
    Contact Person: Tracy K. Riley or Angie Whitacre, Center for Drug

[[Page 51942]]

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.
    Agenda: On October 21, 1998, the committee will participate in a 
general scientific discussion of clinical trial design questions for 
products intended for the treatment of psoriasis. On the morning of 
October 22, 1998, the committee will participate in a scientific 
discussion of clinical trial design issues for systemic 
immunomodulatory biological products intended for the treatment of 
psoriasis. On the afternoon of October 22, 1998, the committee will 
participate in a scientific discussion of clinical trial design 
questions for products intended for the treatment of tinea capitis.
    Procedure: On October 21, 1998, from 8 a.m. to 5 p.m., and on 
October 22, 1998, from 9:30 a.m. to 11:30 a.m. and from 12 m. to 5 
p.m., the meeting will be 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 October 13, 1998. Oral presentations from the public 
will be scheduled between approximately 8:15 a.m. and 8:45 a.m. on 
October 21, 1998, and between approximately 9:30 a.m. and 10 a.m. and 
between approximately 1 p.m. and 1:30 p.m. on October 22, 1998. Time 
allotted for each presentation may be limited. Those desiring to make 
oral presentations should notify the contact person before October 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 October 22, 1998, from 8 a.m. to 
9:30 a.m., and from 11:30 a.m. to 12 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)) regarding 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: September 22, 1998.
 Michael A. Friedman,
 Deputy Commissioner for Operations.
[FR Doc. 98-25906 Filed 9-28-98; 8:45 am]
BILLING CODE 4160-01-F