[Federal Register: May 27, 2004 (Volume 69, Number 103)]
[Notices]               
[Page 30320-30321]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr27my04-71]                         

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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). The meeting will 
be open 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 August 27, 2004, from 8 
a.m. to 5:30 p.m.
    Location: Food and Drug Administration, CDER Advisory

[[Page 30321]]

Committee Conference Room, 5630 Fishers Lane, rm. 1066, 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, 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. Please call the Information 
Line for up-to-date information on this meeting.
    Agenda: The committee will discuss new drug application (NDA) 21-
756, pegaptanib sodium injection (proposed tradename, Macugen) by 
Eyetech Pharmaceuticals, Inc., indicated for the treatment of exudative 
(wet) age-related macular degeneration.
    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 August 13, 
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 by August 13, 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: May 20, 2004.
Peter J. Pitts,
Associate Commissioner for External Relations.
[FR Doc. 04-11946 Filed 5-26-04; 8:45 am]

BILLING CODE 4160-01-S