[Federal Register: September 9, 2003 (Volume 68, Number 174)]
[Page 53175]
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 October 3, 2003, from
8:30 a.m. to 4 p.m.
    Location: Gaithersburg Marriott, Salons E, F, and G, 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 implantable contact
lens for the correction of moderate to high myopia between -3.0
diopters (D) to -20D with or without astigmatism up to 2.5D and is
intended for placement in the posterior chamber of the phakic eye.
Background information, including the attendee list, agenda, and
questions for the committee, will be available to the public 1 business
day before the meeting, on the Internet at http://www.fda.gov/cdrh/panelmtg.html
    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 25,
2003. Oral presentations from the public will be scheduled between
approximately 8:45 a.m. and 9:15 a.m. Near the end of the committee
deliberations on the PMA, a 30-minute open public session will be
conducted for interested persons to address issues specific to the
submission before the committee. Time allotted for each presentation
may be limited. Those desiring to make formal oral presentations should
notify the contact person before September 25, 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 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: September 2, 2003.
Peter J. Pitts,
Associate Commissioner for External Relations.
[FR Doc. 03-22790 Filed 9-8-03; 8:45 am]