[Federal Register Volume 63, Number 188 (Tuesday, September 29, 1998)]
[Notices]
[Pages 51941-51942]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-25906]
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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 October 21 and 22, 1998,
8 a.m. to 5 p.m.
Location: Holiday Inn, Walker Room, Two Montgomery Village Ave.,
Gaithersburg, MD.
Contact Person: Tracy K. Riley or Angie Whitacre, Center for Drug
[[Page 51942]]
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: On October 21, 1998, the committee will participate in a
general scientific discussion of clinical trial design questions for
products intended for the treatment of psoriasis. On the morning of
October 22, 1998, the committee will participate in a scientific
discussion of clinical trial design issues for systemic
immunomodulatory biological products intended for the treatment of
psoriasis. On the afternoon of October 22, 1998, the committee will
participate in a scientific discussion of clinical trial design
questions for products intended for the treatment of tinea capitis.
Procedure: On October 21, 1998, from 8 a.m. to 5 p.m., and on
October 22, 1998, from 9:30 a.m. to 11:30 a.m. and from 12 m. to 5
p.m., the meeting will be open to the public. 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 October 13, 1998. Oral presentations from the public
will be scheduled between approximately 8:15 a.m. and 8:45 a.m. on
October 21, 1998, and between approximately 9:30 a.m. and 10 a.m. and
between approximately 1 p.m. and 1:30 p.m. on October 22, 1998. Time
allotted for each presentation may be limited. Those desiring to make
oral presentations should notify the contact person before October 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 October 22, 1998, from 8 a.m. to
9:30 a.m., and from 11:30 a.m. to 12 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)) regarding 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: September 22, 1998.
Michael A. Friedman,
Deputy Commissioner for Operations.
[FR Doc. 98-25906 Filed 9-28-98; 8:45 am]
BILLING CODE 4160-01-F
