[Federal Register Volume 63, Number 123 (Friday, June 26, 1998)]
[Notices]
[Page 34902]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-17075]
[[Page 34902]]
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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 23, 1998, 8 a.m. to
5 p.m.
Location: Holiday Inn, Ballroom, Two Montgomery Village Ave.,
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: The committee will discuss: (1) Premarket approval
application (PMA) for a toric intraocular lens for primary implantation
for the visual correction of aphakia, and (2) PMA for an excimer laser
for the surgical correction of hyperopia, sphere only, using
photorefractive keratectomy.
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 15, 1998.
Oral presentations from the public will be scheduled between
approximately 8:30 a.m. and 9 a.m. An additional 30-minute time period
will be given for public comment at the end of committee discussion and
prior to voting on each PMA. Time allotted for each presentation may be
limited. Those desiring to make formal oral presentations should notify
the contact person before July 12, 1998, 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 18, 1998.
Michael A. Friedman,
Deputy Commissioner for Operations.
[FR Doc. 98-17075 Filed 6-25-98; 8:45 am]
BILLING CODE 4160-01-F
