[Federal Register Volume 64, Number 119 (Tuesday, June 22, 1999)]
[Notices]
[Page 33308]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-15752]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Dermatologic and Ophthalmic Drugs Advisory Committee, Ophthalmic
Drugs Subcommittee; 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, Ophthalmic Drugs Subcommittee.
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 21, 1999, 8:30 a.m.
to 5 p.m.
Location: Hilton Hotel, Salons A and B, 620 Perry Pkwy.,
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, 301-827-7001, 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. Current information may also be
accessed on the Internet at the FDA Website ``www.FDA.GOV''.
Agenda: The subcommittee will discuss new drug application (NDA)
21-023 (cyclosporine ophthalmic emulsion, 0.05%, Allergan, Inc.), for
treatment of moderate to severe keratoconjunctivitis sicca.
Procedure: Interested persons may present data, information, or
views, orally or in writing, on issues pending before the subcommittee.
Written submissions may be made to the contact person by July 16, 1999.
Oral presentations from the public will be scheduled between
approximately 8:30 a.m. and 9:30 a.m. Time allotted for each
presentation may be limited. Those desiring to make formal
presentations should notify the contact person before July 16, 1999,
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 16, 1999.
Linda A. Suydam,
Senior Associate Commissioner.
[FR Doc. 99-15752 Filed 6-21-99; 8:45 am]
BILLING CODE 4160-01-F
