[Federal Register: June 22, 2001 (Volume 66, Number 121)]
[Notices]
[Page 33545-33546]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr22jn01-61]
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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). At least one
portion of the meeting will be closed 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 July 20, 2001, 9:30 a.m.
to 5 p.m.
Location: Corporate Bldg., conference room 020B, 9200 Corporate
Blvd., Rockville, MD.
Contact: 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: The committee will discuss, make recommendations, and vote
on a premarket approval application (PMA) for soft contact lenses for
the optical correction of refractive ametropia in phakic or aphakic
persons with nondiseased eyes with up to approximately 1.50 diopters of
astigmatism. The lenses may be prescribed for extended wear for up to
30 nights of continuous wear between removals for cleaning and
disinfection or for disposal of the lens, as recommended by the eye
care professional. Background information, including the agenda and
questions for the committee, will be made available to the public on
July 19, 2001, on the Internet at http://www.fda.gov/cdrh/
panelmtg.html.
Procedure: On July 20, 2001, from 9:30 a.m. to 3:30 p.m., the
meeting is open to the public. 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
July 13, 2001. Formal oral presentations from the public will be
scheduled between approximately 9:45 a.m. and 10:15 a.m. Time allotted
for each presentation may be limited. 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. Those desiring to make formal oral
presentations should notify the contact person before July 13, 2001,
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.
Closed Committee Deliberations: On July 20, 2001, from 3:30 p.m. to
5 p.m., the meeting will be closed to permit FDA to present to the
committee trade secret and/or confidential commercial information (5
U.S.C. 552b(c)(4))
[[Page 33546]]
regarding pending issues and applications.
Notice of this meeting is given under the Federal Advisory
Committee Act (5 U.S.C. app. 2).
Dated: June 14, 2001.
Linda A. Suydam,
Senior Associate Commissioner.
[FR Doc. 01-15667 Filed 6-21-01; 8:45 am]
BILLING CODE 4160-01-S