[Federal Register Volume 67, Number 130 (Monday, July 8, 2002)]
[Notices]
[Pages 45128-45129]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-16904]


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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 August 1, 2002, from 
8:30 a.m. to 4:30 p.m., and on August 2, 2002, from 8:30 a.m. to 3 p.m.
    Location: Hilton Washington 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, ext. 127, 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 August 1, 2002, the committee will discuss, make 
recommendations, and vote on a premarket approval application (PMA) for 
an excimer laser system for use in wavefront guided laser in situ 
keratomileusis correction for the reduction or elimination of myopia up 
to -7 diopters (D) with less than -0.50D of astigmatism at the 
spectacle plane in subjects who are 21 years of age or older. On August 
2, 2002, the committee will discuss issues related to the development 
of an FDA guidance, an American National Standards Institute standard, 
and an International Standards Organization standard for intraocular 
lenses for the treatment of myopia or hyperopia in phakic patients. The 
committee will address questions on clinical study design, specular 
microscopy (endothelial cell counts), lens opacity, and contrast 
sensitivity. Background information for each day's topic, including the 
attendee list, agenda, and questions for the committee, will be 
available to the public 1-business day before the meeting, on the 
Internet at http://www.fda.gov/cdrh/panelmtg.html. Material for the 
August 1, 2002, session will be posted on July 31, 2002; material for 
the August 2, 2002, session will be posted on August 1, 2002.
    Procedure: On both days from 8:30 a.m. to 3 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 26, 2002. 
On August 1, 2002, formal 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, a 30-minute open public session 
will be conducted for interested persons to address issues specific to 
the submission before the committee. On August 2, 2002, oral 
presentations from the public will be scheduled between approximately 
8:45 a.m. and 9:15 a.m. Near the end of committee deliberations on the 
agenda topics, a 30-minute open public session will be conducted for 
interested persons to address issues specific to the topics before the 
committee. Time allotted for each presentation may be limited. Those 
desiring to make formal oral presentations should notify the contact 
person before July 26, 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.
    Closed Committee Deliberations. On August 1, 2002, from 3 p.m. to 
4:30 p.m., the meeting will be closed to permit FDA staff to present to 
the committee trade secret and/or confidential commercial information 
relevant to pending and future device submissions for vitreoretinal, 
surgical and diagnostic devices, intraocular and corneal implants, and 
contact lenses. This portion of the meeting will be closed to permit 
discussion of this information (5 U.S.C. 552b(c)(4)).
    Persons attending FDA's advisory committee meetings are advised 
that the agency is not responsible for providing access to electrical 
outlets.
    FDA welcomes the attendance of the public at its advisory committee

[[Page 45129]]

meetings and will make every effort to accommodate persons with 
physical disabilities or special needs. If you require special 
accommodations due to a disability, please contact AnnMarie Williams, 
Conference Management Staff, at 301-594-1283, ext. 113, at least 7 days 
in advance of the meeting.
    Notice of this meeting is given under the Federal Advisory 
Committee Act (5 U.S.C. app. 2).

    Dated: June 26, 2002.
William K. Hubbard,
Senior Associate Commissioner for Policy, Planning, and Legislation.
[FR Doc. 02-16904 Filed 7-5-02; 8:45 am]
BILLING CODE 4160-01-S