[Federal Register: March 5, 2003 (Volume 68, Number 43)]
[Page 10482-10483]
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 March 17, 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, 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 12534. 
Please call the Information Line for up-to-date information on this 
    Agenda: The committee will discuss new drug application (NDA) 21-
414, VITRASE (hyaluronidase for intravitreal injection), ISTA 
Pharmaceuticals, for the treatment of vitreous hemorrhage. The 
background material for this meeting will be posted on the Internet 
when available or 1 working day before the meeting at http://

    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 March 10, 
2003. 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 March 10, 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 
    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.
    FDA regrets that it was unable to publish this notice 15 days prior 
to the March 17, 2003, Dermatologic and Ophthalmic Drugs Advisory 
Committee meeting. Because the agency believes there is some urgency to 
bring this issue to public discussion and qualified members of the 
Dermatologic and Ophthalmic Drugs Advisory Committee

[[Page 10483]]

were available at this time, the Commissioner of Food and Drugs 
concluded that it was in the public interest to hold this meeting even 
if there was not sufficient time for the customary 15-day public 
    Notice of this meeting is given under the Federal Advisory 
Committee Act (5 U.S.C. app. 2).

    Dated: February 26, 2003.
William K. Hubbard,
Associate Commissioner for Policy and Planning.
[FR Doc. 03-5074 Filed 3-4-03; 8:45 am]