[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