[Federal Register Volume 65, Number 36 (Wednesday, February 23, 2000)]
[Notices]
[Page 8982]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-4165]


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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 March 17, 2000, 8:30 
a.m. to 3 p.m.
    Location: Corporate Bldg., conference room 20B, 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 e-mail 
[email protected], 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: FDA staff will make a brief presentation to the committee 
on the least burdensome provisions of the FDA Modernization Act of 
1997. The committee will discuss, make recommendations, and vote on a 
premarket approval application (PMA) for an excimer laser for the 
reduction or elimination of hyperopia up to +6.00 D of sphere and up to 
-6.00 D of astigmatism at the spectacle plane using laser in situ 
keratomileusis.
    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 March 10, 
2000. Formal oral presentations from the public will be scheduled 
between approximately 8:45 a.m. and 9:15 a.m. Near the end of the 
committee deliberations on the 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 March 10, 2000, 
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: February 14, 2000.
Linda A. Suydam,
Senior Associate Commissioner.
[FR Doc. 00-4165 Filed 2-22-00; 8:45 am]
BILLING CODE 4160-01-F