[Federal Register Volume 64, Number 115 (Wednesday, June 16, 1999)]
[Notices]
[Page 32238]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-15183]
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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 July 22 and 23, 1999, 8
a.m. to 5:30 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, 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 July 22, 1999, the committee will discuss, make
recommendations, and vote on a premarket approval application (PMA) for
the correction of myopia with and without astigmatism using laser in-
situ keratomileusis (LASIK). The committee will also discuss, make
recommendations, and vote on a holmium laser for the correction of
hyperopia using laser thermal keratomileusis. On July 23, 1999, the
committee will discuss, make recommendations, and vote on a soft
acrylic intraocular lens for the visual correction of aphakia after
cataract extraction. The committee will also discuss, make
recommendations, and vote on a PMA for the correction of myopia with
and without astigmatism using LASIK.
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 July 12, 1999.
Oral presentations from the public will be scheduled between
approximately 8:30 a.m. and 9 a.m. on July 22 and 23, 1999. 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. Time allotted for each
presentation may be limited. Those desiring to make formal oral
presentations should notify the contact person before July 12, 1999,
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: June 9, 1999.
Michael A. Friedman,
Deputy Commissioner for Operations.
[FR Doc. 99-15183 Filed 6-15-99; 8:45 am]
BILLING CODE 4160-01-F
