[Federal Register: April 17, 2003 (Volume 68, Number 74)]
[Page 18991]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]



Food and Drug Administration

Ophthalmic Devices Panel of the Medical Devices Advisory 
Committee; Notice of Meeting

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: Ophthalmic Devices Panel of the Medical Devices 
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 May 23, 2003, from 8:30 
a.m. to 3:30 p.m.
    Location: Gaithersburg Marriott, Salons A, B and C, 9751 
Washingtonian Blvd., Gaithersburg, MD.
    Contact Person: Sara M. Thornton, Center for Devices and 
Radiological Health (HFZ-460), Food and Drug Administration, 9200 
Corporate Blvd., Rockville, MD 20850, 301-594-2053, ext. 127, or FDA 
Advisory Committee Information Line, 1-800-741-8138 (301-443-0572 in 
the Washington, DC area), code 12396. Please call the Information Line 
for up-to-date information on this meeting.
    Agenda: The committee will discuss, make recommendations, and vote 
on a premarket approval application (PMA) for an intraocular lens for 
primary implantation in the capsular bag for the correction of aphakia 
in an adult in whom a cataractous lens has been removed and who may 
benefit from improved near, intermediate and distance vision without 
spectacles. Background information for the day's topic, including the 
attendee list, agenda, and questions for the committee, will be 
available to the public one business day before the meeting, on the 
Internet at http://www.fda.gov/cdrh/panel/index.html. Material will be 
posted on May 22, 2003.
    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 May 16, 2003. 
Oral presentations from the public will be scheduled between 
approximately 8:45 a.m. and 9:15 a.m., and for 30 minutes near the end 
of the committee deliberations on the PMA. Time allotted for each 
presentation may be limited. Those desiring to make formal oral 
presentations should notify the contact person before May 16, 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 AnnMarie Williams, 
Conference Management Staff, at 301-594-1283, ext. 113, 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: April 10, 2003.
Linda Arey Skladany,
Associate Commissioner for External Relations.
[FR Doc. 03-9386 Filed 4-16-03; 8:45 am]