[Federal Register Volume 63, Number 43 (Thursday, March 5, 1998)]
[Notices]
[Page 10919]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-5630]
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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 regulatory issues.
Date and Time: The meeting will be held on March 19 and 20, 1998,
8:30 a.m. to 5:30 p.m.
Location: Holiday Inn, Walker Room, Two Montgomery Village Ave.,
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, 301-443-5455, 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 March 19, 1998, the committee will discuss generic
topical dermatologicals draft guidance. On March 20, 1998, the
committee will participate in a scientific discussion of clinical trial
design questions for products intended for the treatment of psoriasis.
Procedure: On March 19, 1998, from 8:30 a.m. to 1 p.m., and on
March 20, 1998, from 8:30 a.m. to 5:30 p.m., the meeting is open to the
public. Interested persons may present data, information, or views,
orally or in writing, on issues pending before the committee. Written
submissions should be made to the contact person by March 11, 1998.
Oral presentations from the public will be scheduled between
approximately 8:30 a.m. and 9 a.m., on March 19 and 20, 1998. Time
allotted for each presentation may be limited. Those desiring to make
formal oral presentations should notify the contact person before March
13, 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.
Closed Committee Deliberations: On March 19, 1998, from 1 p.m. to
5:30 p.m., the meeting will be closed to permit discussion and review
of trade secret and/or confidential information (5 U.S.C. 552b(c)(4)).
This portion of the meeting will be closed to permit discussion on
pending investigational new drug applications issues.
Notice of this meeting is given under the Federal Advisory
Committee Act (5 U.S.C. app. 2).
Dated: February 25, 1998.
Michael A. Friedman,
Deputy Commissioner for Operations.
[FR Doc. 98-5630 Filed 3-4-98; 8:45 am]
BILLING CODE 4160-01-F
