[Federal Register Volume 68, Number 174 (Tuesday, September 9, 2003)]
[Notices]
[Page 53175]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-22790]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration


Ophthalmic Devices Panel of the Medical Devices 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: 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 
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 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]
BILLING CODE 4160-01-S