[Federal Register: June 15, 2004 (Volume 69, Number 114)]
[Notices]               
[Page 33392]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr15jn04-49]                         

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

 
Dermatologic and Ophthalmic Drugs Advisory Committee and the Drug 
Safety and Risk Management 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). The meeting will 
be open to the public.
    Name of Committees: Dermatologic and Ophthalmic Drugs Advisory 
Committee and the Drug Safety and Risk Management Advisory Committee.
    General Function of the Committees: To provide advice and 
recommendations to the agency on FDA's regulatory issues.
    Date and Time: The meeting will be held on July 12, 2004, from 8 
a.m. to 5:30 p.m.
    Location: Food and Drug Administration, Center for Drug Evaluation 
and Research Advisory Committee Conference Room, rm. 1066, 5630 Fishers 
Lane, Rockville, MD.
    Contact Person: Kimberly Littleton Topper, Center for Drug 
Evaluation and Research (HFD-21), Food and Drug Administration, 5600 
Fishers Lane (for express delivery: 5630 Fishers Lane, rm. 1093), 
Rockville, MD 20857, 301-827-7001, FAX: 301-827-6801, e-mail: 
topperk@cder.fda.gov, or FDA Advisory Committee Information Line, 1-
800-741-8138 (301-443-0572 in the Washington, DC area), code 3014512534 
or 3014512535. Please call the Information Line for up-to-date 
information on this meeting.
    Agenda: The committee will discuss new drug application (NDA) 21-
701, proposed tradename TAZORAL (oral tazarotene) 1.5 milligram (mg) 
and 4.5 mg capsules, Allergan, Inc., proposed for the treatment of 
moderate to severe psoriasis, including risk management options to 
prevent fetal exposure.
    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 July 2, 2004. 
Oral presentations from the public will be scheduled between 
approximately 1 p.m. and 2 p.m. Time allotted for each presentation may 
be limited. Those desiring to make formal oral presentations should 
notify the contact person before July 2, 2004, 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.
    Persons attending FDA's advisory committee meetings are advised 
that the agency is not responsible for providing access to electrical 
outlets.
    FDA welcomes the attendance of the public at its advisory committee 
meetings and will make every effort to accommodate persons with 
physical disabilities or special needs. If you require special 
accommodations due to a disability, please contact Kimberly Littleton 
Topper at least 7 days in advance of the meeting.
    Notice of this meeting is given under the Federal Advisory 
Committee Act (5 U.S.C. app. 2).

    Dated: June 7, 2004.
William K. Hubbard,
Associate Commissioner for Policy and Planning.
[FR Doc. 04-13428 Filed 6-14-04; 8:45 am]

BILLING CODE 4160-01-S