[Federal Register Volume 65, Number 203 (Thursday, October 19, 2000)]
[Notices]
[Page 62722]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-26787]



[[Page 62722]]

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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). At least one 
portion of the meeting will be closed 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's regulatory issues.
    Date and Time: The meeting will be held on November 16, 2000, 9 
a.m. to 5:30 p.m.
    Location: Holiday Inn, Grand Ballroom, Two Montgomery Village Ave., 
Gaithersburg, MD.
    Contact: Jaime Henriquez, Center for Drug Evaluation and Research 
(HFD-21), Food and Drug Administration, 5600 Fishers Lane (for express 
delivery, 5630 Fishers Lane, rm. 1066), 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: On November 16, 2000, the committee will discuss new drug 
application (NDA) 50-777, Protopic (tacrolimus) Ointment, 
Fujisawa Healthcare, Inc., for short- and long-term treatment of the 
signs and symptoms of atopic dermatitis in adult and pediatric patients 
2 years of age or older.
    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 6, 
2000. Oral presentations from the public will be scheduled between 
approximately 1:30 p.m. and 2:30 p.m. Time allotted for each 
presentation may be limited. Those desiring to make formal oral 
presentations should notify the contact person before November 6, 2000, 
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.
    Closed Committee Deliberations: On November 16, 2000, from 9 a.m. 
to 10 a.m., the meeting will be closed to permit discussion and review 
of trade secret and/or confidential information regarding NDA issues (5 
U.S.C. 552b(c)(4)).
    Notice of this meeting is given under the Federal Advisory 
Committee Act (5 U.S.C. app. 2).

    Dated: October 11, 2000.
Linda A. Suydam,
Senior Associate Commissioner.
[FR Doc. 00-26787 Filed 10-18-00; 8:45 am]
BILLING CODE 4160-01-F