[Federal Register Volume 65, Number 202 (Wednesday, October 18, 2000)]
[Notices]
[Pages 62363-62364]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-26741]


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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 November 8, 2000, 8:30 
a.m. to 5 p.m.
    Location: Holiday Inn, Walker/Whetstone Rooms, Two Montgomery 
Village Ave., Gaithersburg, MD.

[[Page 62364]]

    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, 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: The committee will discuss, make recommendations, and vote 
on a premarket approval application (PMA) for a collagen glaucoma 
drainage device for the reduction of intraocular pressure in patients 
with open-angle glaucoma uncontrolled on maximum tolerated medical 
therapy. The committee will also discuss issues related to the 
development of guidance for the postapproval study of extended wear 
contact lenses used beyond 7 days. Study design topics will include the 
type of study, definition of endpoints, and selection of participating 
study sites.
    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 November 1, 
2000. 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, an additional 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 November 1, 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: October 11, 2000.
Linda A. Suydam,
Senior Associate Commissioner.
[FR Doc. 00-26741 Filed 10-17-00; 8:45 am]
BILLING CODE 4160-01-F