[Federal Register Volume 63, Number 12 (Tuesday, January 20, 1998)]
[Notices]
[Page 2988]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-1170]
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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 regulatory issues.
Date and Time: The meeting will be held on February 12 and 13,
1998, 8 a.m. to 5 p.m.
Location: Parklawn Bldg., conference rooms D and E, 5600 Fishers
Lane, Rockville, MD.
Contact Person: Sara M. Thornton, Center for Devices and
Radiological Health (HFZ-460), Food and Drug Administration, 9200
Corporate Blvd., Rockville, MD 20850, 301-594-2053, or FDA Advisory
Committee Information Line, 1-800-741-8138 (301-443-0572 in the
Washington, DC area), code 12396, or the world wide web at http://
www.fda.gov. Please call the Information Line for up-to-date
information on this meeting.
Agenda: On February 12, 1998, the committee will discuss specific
questions related to the development of contact lens extended wear
clinical testing guidance for 7-day extended wear, prolonged extended
wear beyond 7 days, and overnight use of contact lenses for
orthokeratology. On February 13, 1998, the committee will discuss, make
recommendations, and vote on a premarket approval application (PMA) for
a broad beam excimer laser for the correction of myopia with
astigmatism using laser in-situ keratomileusis. The committee will also
discuss, make recommendations, and vote on a PMA for a scanning excimer
laser for the correction of myopia with astigmatism 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 February 6,
1998. Oral presentations from the public will be scheduled between
approximately 8:30 a.m. and 9:30 a.m. on February 12 and 13, 1998. Time
allotted for each presentation may be limited. Those desiring to make
formal oral presentations should notify the contact person before
February 2, 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: January 12, 1998.
Michael A. Friedman,
Deputy Commissioner for Operations.
[FR Doc. 98-1170 Filed 1-16-98; 8:45 am]
BILLING CODE 4160-01-F
