[Federal Register Volume 62, Number 203 (Tuesday, October 21, 1997)]
[Notices]
[Pages 54639-54640]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-27816]


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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.

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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: 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 November 13 and 14, 
1997, 8:30 a.m. to 5:30 p.m.
    Location: Holiday Inn, Versailles Ballrooms I and II, 8120 
Wisconsin Ave., Bethesda, 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.

[[Page 54640]]

    Agenda: On November 13, 1997, the committee will discuss new drug 
application (NDA) 20-788, PropeciaTM (finasteride 1 
milligram tablets, Merck Research Laboratories), for treatment of 
androgenetic alopecia to increase hair growth and to prevent further 
hair loss. On November 14, 1997, the committee will participate in a 
scientific discussion of clinical trial design questions for products 
intended for the treatment of burn wounds. This is one segment of an 
overall effort by the agency to develop a guidance document on wound 
healing products.
    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 November 4, 
1997. Oral presentations from the public will be scheduled between 
approximately 8:30 a.m. and 9 a.m., and between approximately 1 p.m. 
and 1:30 p.m. on both days. Time allotted for each presentation may be 
limited. Those desiring to make formal oral presentations should notify 
the contact person before November 4, 1997, 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: October 9, 1997.
Michael A. Friedman,
Deputy Commissioner for Operations.
[FR Doc. 97-27816 Filed 10-20-97; 8:45 am]
BILLING CODE 4160-01-F