[Federal Register: October 23, 2001 (Volume 66, Number 205)]
[Notices]
[Page 53616]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr23oc01-77]
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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 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/
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 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]
BILLING CODE 4160-01-S