[Federal Register Volume 66, Number 160 (Friday, August 17, 2001)]
[Notices]
[Page 43265]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-20802]


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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 September 21, 2001, from 
8 a.m. to 5 p.m.
    Location: Corporate Bldg., conference room 20B, 9200 Corporate 
Blvd., Rockville, 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, [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: The committee will discuss, make recommendations, and vote 
on a premarket approval application (PMA) for soft contact lenses for 
the correction of refractive ametropia (myopia or hyperopia) in phakic 
or aphakic persons with nondiseased eyes exhibiting astigmatism of 2.00 
diopters (D) or less that does not interfere with visual acuity. The 
lenses may be prescribed for daily wear or extended wear for 1 to 30 
days between removals for cleaning and disinfection or for disposal of 
the lens, as recommended by the eye care professional. The lens may be 
prescribed in spherical powers ranging from +20.00 D to -20.00 D. The 
committee will also discuss, make recommendations, and vote on a 
conductive keratoplasty refractive surgical device for the reduction of 
previously untreated spherical hyperopia in patients 40 years of age or 
greater, who have 0.75 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 and cycloplegic refraction spherical 
equivalent 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 September 20, 2001, 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 14, 
2001. Oral presentations from the public will be scheduled between 
approximately 8:15 a.m. and 8:45 a.m. Near the end of the committee 
deliberations on each 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 September 7, 
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: August 10, 2001.
Bonnie H. Malkin,
Acting Senior Associate Commissioner.
[FR Doc. 01-20802 Filed 8-16-01; 8:45 am]
BILLING CODE 4160-01-S