[Federal Register: January 4, 2002 (Volume 67, Number 3)]
[Page 602]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]



Food and Drug Administration

Ophthalmic Devices Panel of the Medical Devices Advisory 
Committee; Notice of Meeting

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.


    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 January 17, 2002, from 
9:30 a.m. to 5 p.m., and January 18, 2002, from 8:30 a.m. to 3:30 p.m.
    Location: Hilton DC North--Gaithersburg, Salons A, B, and C, 620 
Perry Pkwy., 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, SMT@CDRH.FDA.GOV, 
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: On January 17, 2002, the committee will discuss, make 
recommendations, and vote on a premarket approval application (PMA) on 
an endocapsular tension ring for the stabilization of the lens capsular 
bag. On January 18, 2002, the committee will discuss, make 
recommendations, and vote on a PMA on an orthokeratology contact lens 
for corneal refractive therapy with overnight wear for the temporary 
reduction of myopia. Background information for each day's topic, 
including the agenda and questions for the committee, will be available 
to the public one business day before the meeting, on the Internet at 
http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/cdrh/panelmtg.html. Material for the January 17 
session will be posted on January 16, 2002; material for the January 18 
session will be posted on January 17, 2002.
    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 January 7, 
2002. On January 17, 2002, formal oral presentations from the public 
will be scheduled between approximately 9:45 a.m. and 10:15 a.m., and 
on January 18, 2002, between approximately 8:45 and 9:15 a.m. Near the 
end of the committee deliberations on each PMA, a 30-minute open public 
session will be conducted for interested persons to address issues 
specific to the submission before the committee. Those desiring to make 
formal oral presentations should notify the contact person before 
January 7, 2002, 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.
    FDA regrets that it was unable to publish this notice 15 days prior 
to the January 17 and 18, 2002, Ophthalmic Devices Panel of the Medical 
Devices Advisory Committee meeting. Because the agency believes there 
is some urgency to bring these issues to public discussion and 
qualified members of the Ophthalmic Devices Panel of the Medical 
Devices Advisory Committee were available at this time, the 
Commissioner of Food and Drugs concluded that it was in the public 
interest to hold this meeting even if there was not sufficient time for 
the customary 15-day public notice.
    Notice of this meeting is given under the Federal Advisory 
Committee Act (5 U.S.C. app. 2).

    Dated: December 28, 2001.
Linda A. Suydam,
Senior Associate Commissioner.
[FR Doc. 02-152 Filed 1-3-02; 8:45 am]