[Federal Register: October 23, 2001 (Volume 66, Number 205)]
[Page 53616]
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 November 30, 2001, from 
9:45 a.m. to 4:30 p.m.
    Location: Holiday Inn, Walker/Whetstone Rooms, Two Montgomery 
Village Ave., Gaithersburg, MD.
    Contact: Sara M. Thornton, Center for Devices and Radiological 
Health (HFZ-460), Food and Drug Administration, 9200 Corporate Blvd., 
Rockville, MD 20850, 301-594-2053, SMT@CDRH.FDA.GOV, 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 a conductive keratoplasty 
(CK) refractive surgical device for the reduction of previously 
untreated spherical hyperopia in patients 40 years of age or greater, 
who have 0.75 diopter (D) to 3.25 D of cycloplegic spherical hyperopia, 
with less than or equal to 0.75 D of refractive astigmatism (minus 
cylinder format), a cycloplegic spherical equivalent of 0.75 D to 3.00 
D, and no more than 0.50 D difference between preoperative manifest 
refraction spherical equivalent (MRSE) and cycloplegic refraction 
spherical equivalent (CRSE) which shows some regression of the initial 
effect over time. Background information, including the agenda and 
questions for the committee, will be available to the public on 
November 29, 2001, on the Internet at http://www.fda.gov/cdrh/
    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 November 16, 
2001. Formal oral presentations from the public will be scheduled 
between approximately 9:50 a.m. and 10:20 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. Those desiring to make formal oral 
presentations should notify the contact person before November 16, 
2001, 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: October 16, 2001.
Linda A. Suydam,
Senior Associate Commissioner.
[FR Doc. 01-26574 Filed 10-22-01; 8:45 am]