[Federal Register Volume 63, Number 122 (Thursday, June 25, 1998)]
[Notices]
[Pages 34655-34656]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-16851]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration


Ophthalmic Drugs Subcommittee of the 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: Ophthalmic Drugs Subcommittee of the 
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 July 22, 1998, 8 a.m. to 
5 p.m.
    Location: Holiday Inn, Versailles Ballrooms I and II, 8120 
Wisconsin Ave., Bethesda, MD.

[[Page 34656]]

    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, 301-827-7001, 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: The committee will discuss new drug application (NDA) 20-
961, Vitravene (fomivirsen sodium intravitreal injection, 
ISIS Pharmaceuticals), for treatment of cytomegalovirus (CMV) retinitis 
in patients with acquired immune deficiency syndrome (AIDS).
    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 July 17, 1998. 
Oral presentations from the public will be scheduled between 
approximately 8 a.m. and 8:30 a.m., and between approximately 1 p.m. 
and 1:30 p.m. Time allotted for each presentation may be limited. Those 
desiring to make formal oral presentations should notify the contact 
person before July 17, 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: June 12, 1998.
Michael A. Friedman,
Deputy Commissioner for Operations.
[FR Doc. 98-16851 Filed 6-24-98; 8:45 am]
BILLING CODE 4160-01-F