[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
