[Federal Register Volume 64, Number 202 (Wednesday, October 20, 1999)]
[Notices]
[Pages 56509-56510]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-27418]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
This notice announces a forthcoming meeting of a public advisory
committee
[[Page 56510]]
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 4 and 5, 1999,
8:30 a.m. to 5:30 p.m.
Location: Hilton Hotel, Salons A, B, and C, 620 Perry Pkwy.,
Gaithersburg, MD 20877, 301-977-8900.
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 FDA Website at www.fda.gov.
Agenda: On November 4, 1999, during the morning session, the
committee will discuss new drug application (NDA) 21-022,
LoproxTM (ciclopirox nail lacquer), Hoechst Marion Roussel,
Inc., for treatment of onychomycosis. On November 4, 1999, during the
afternoon session, the committee will participate in a scientific
discussion of clinical trial design questions for products intended for
the treatment of hand dermatitis. On November 5, 1999, during the
afternoon session, the committee will discuss NDA 20-965,
Levulan (aminolevulinic acid HCL) KerastickTM for
Topical Solution, 20 percent, Dusa Pharmaceuticals, Inc., for use in
the treatment of multiple actinic keratoses of the face and scalp.
Procedure: On November 4, 1999, from 8:30 a.m. to 5:30 p.m. and on
November 5, 1999, from 1 p.m. to 5:30 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 should be made to the contact person by October 29, 1999.
Oral presentations from the public will be scheduled between
approximately 8:30 a.m. and 9 a.m. and between approximately 1 p.m. and
1:30 p.m. on November 4, 1999. Time allotted for each presentation may
be limited. Those desiring to make oral presentations should notify the
contact person before October 29, 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.
Closed Committee Deliberations: On November 5, 1999, from 8:30 a.m.
to 1 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))
regarding pending NDA's issues.
Notice of this meeting is given under the Federal Advisory
Committee Act (5 U.S.C. app. 2).
Dated: October 12, 1999.
Linda A. Suydam,
Senior Associate Commissioner.
[FR Doc. 99-27418 Filed 10-19-99; 8:45 am]
BILLING CODE 4160-01-F
