[Federal Register: August 17, 2001 (Volume 66, Number 160)]
[Notices]
[Page 43265]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr17au01-106]
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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, 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 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