[Federal Register Volume 65, Number 68 (Friday, April 7, 2000)]
[Notices]
[Pages 18340-18341]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-8600]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration


Opthalmic 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 May 11, 2000, 9:30 a.m. 
to 5 p.m., and May 12, 2000, 8:30 a.m. to 5 p.m.
    Location: Hilton Hotel, Salons A and B, 620 Perry Pkwy., 
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, [email protected], 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: On May 11, 2000, the committee will discuss, make 
recommendations, and vote on a premarket approval application (PMA) for 
reduction or elimination of hyperopia (+0.5 to +5.00 diopters of 
sphere) with astigmatism (+0.5 to +4.0 diopters of cylinder) using 
photorefractive keratectomy (PRK).
    On May 12, 2000, the committee will discuss issues related to the 
design and development of clinical protocols to support claims of 
reduced posterior capsular opacification (PCO) for intraocular lenses 
(IOL's). The topics for discussion will include study,

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methodology, controls, clinical endpoints, and data analysis. The 
committee will also discuss issues related to the development of 
guidance for refractive implants (phakic IOL's and corneal implants). 
The topics for discussion will include the scope of the proposed 
guidance, the maintenance of endothelial cell counts, and 
cataractogenesis due to the presence of an implant. As the materials 
become available, background information, questions for the panel, a 
bibliography for the PCO discussion, and an overview of the proposed 
clinical study section and questions for the panel for the refractive 
implants discussion will be made available to the public on FDA's 
website at http://www.fda.gov/ohrms/dockets/ac/cdrh00.htm#ophthalmicdevices.
    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 1, 2000. 
Oral presentations from the public will be scheduled between 
approximately 9:15 a.m. and 9:45 a.m. on May 11, 2000, and between 
approximately 8:45 a.m. and 9:15 a.m. on May 12, 2000. On May 11, 2000, 
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 May 1, 2000, 
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.
    Notice of this meeting is given under the Federal Advisory 
Committee Act (5 U.S.C. app. 2).

    Dated: March 30, 2000.
Linda A. Suydam,
Senior Associate Commissioner.
[FR Doc. 00-8600 Filed 4-6-00; 8:45 am]
BILLING CODE 4160-01-F