[Federal Register Volume 63, Number 88 (Thursday, May 7, 1998)]
[Notices]
[Page 25214]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-12170]


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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 June 5, 1998, 9 a.m. to 
5 p.m.
    Location: Corporate Bldg., conference room 020B, 9200 Corporate 
Blvd., 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 (WWW) at http:/
/www.fda.gov. 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 an excimer laser for the 
correction of myopia using laser in-situ keratomileusis. FDA staff will 
present to the committee the clinical requirements section of the 
proposed International Standards Organization standard for ophthalmic 
viscosurgical devices.
    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 May 29, 1998. 
Oral presentations from the public will be scheduled between 
approximately 9:30 a.m. and 10 a.m., and between approximately 1 p.m. 
and 1:30 p.m. An additional 30-minute time period will be given for 
public comment at the end of the panel discussion on the PMA. Time 
allotted for each presentation may be limited. Those desiring to make 
formal oral presentations should notify the contact person before May 
29, 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: April 30, 1998.
Michael A. Friedman,
Deputy Commissioner for Operations.
[FR Doc. 98-12170 Filed 5-6-98; 8:45 am]
BILLING CODE 4160-01-F