[Federal Register: January 4, 2002 (Volume 67, Number 3)]
[Notices]
[Page 602]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr04ja02-79]
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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 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]
BILLING CODE 4160-01-S