[Federal Register: October 20, 1999 (Volume 64, Number 202)]
[Notices]               
[Page 56509-56510]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr20oc99-66]                         

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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

[[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, 
Loprox<SUP>TM</SUP> (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<Register> (aminolevulinic acid HCL) Kerastick<SUP>TM</SUP> 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