[Federal Register Volume 66, Number 121 (Friday, June 22, 2001)]
[Notices]
[Pages 33545-33546]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-15667]


-----------------------------------------------------------------------

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.

-----------------------------------------------------------------------

    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, [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 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