[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