[Federal Register Volume 62, Number 185 (Wednesday, September 24, 1997)]
[Notices]
[Pages 49987-49988]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-25265]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration


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 October 20, 1997, 9 a.m. 
to 5 p.m., and October 21, 1997, 8:30 a.m. to 5 p.m.
    Location: Holiday Inn, Walker and Whetstone Rooms, 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, 301-594-2053, or FDA Advisory 
Committee Information Line, 1-800-741-8138 (301-443-0572 in the 
Washington, DC area), code 12396, or from the Internet: http://

[[Page 49988]]

 www.fda.gov. Please call the Information Line for up-to-date 
information on this meeting.
    Agenda: On October 20, 1997, the committee will discuss issues 
relating to a premarket approval application for a surface modified 
intraocular lens (IOL) in addition to a review of an update of the FDA 
``grid'' of historical IOL data. A product development protocol (PDP) 
based on the draft guidance document for monofocal IOL's will be 
discussed. On October 21, 1997, the committee will discuss proposed 
extensions to the draft guidance document for refractive surgical 
lasers, specifically, clinical criteria for the determination of safety 
and effectiveness for photorefractive keratectomy (PRK) and laser in-
situ keratomileusis (LASIK) for myopia, astigmatism, hyperopia, and 
other refractive indications. A PDP for excimer lasers for PRK will 
also be discussed. Single copies of the above-mentioned guidance 
documents are available to the public by contacting the Division of 
Small Manufacturers Assistance, 1350 Piccard Dr., Rockville, MD 20851, 
1-800-638-2041, or from the Internet: http://www.fda.gov/cdrh/
draftgui.html.
    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 October 10, 
1997. Oral presentations from the public will be scheduled between 
approximately 8:30 a.m. and 9:30 a.m. on October 20 and 21, 1997. Time 
allotted for each presentation may be limited. Those desiring to make 
formal oral presentations should notify the contact person before 
October 10, 1997, 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: September 16, 1997.
Michael A. Friedman,
Deputy Commissioner for Operations.
[FR Doc. 97-25265 Filed 9-23-97; 8:45 am]
BILLING CODE 4160-01-F