[Federal Register: August 18, 2003 (Volume 68, Number 159)]
[Page 49488]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]



Food and Drug Administration

Dermatologic and Ophthalmic Drugs Advisory Committee; Notice of 

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.


    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 
    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 September 9 and 10, 
2003, from 8 a.m. to 5:30 p.m.
    Location: Holiday Inn, The Ballrooms, Two Montgomery Village Ave., 
Gaithersburg, 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, 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 September 9, 2003, the committee will discuss the 
efficacy and safety of submission tracking number biologics licensing 
application 125075/0, Efalizumab (Raptiva) by Genentech, Inc., to be 
used in the treatment of adult patients with moderate to severe plaque 
psoriasis. On September 10, 2003, the committee will discuss new drug 
application (NDA) 21-576, Methyl Aminolevulinate Hydrochloride (methyl 
aminolevulinate cream, 168 milligram/gram) by PhotoCure ASA, for 
treatment of basal cell carcinoma.
    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 September 1, 
2003. Oral presentations from the public will be scheduled between 
approximately 1 p.m. and 2 p.m. on both days. Time allotted for each 
presentation may be limited. Those desiring to make formal oral 
presentations should notify the contact person before September 3, 
2003, 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 
    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: August 12, 2003.
Peter J. Pitts,
Associate Commissioner for External Relations.
[FR Doc. 03-20952 Filed 8-15-03; 8:45 am]