[Federal Register: July 8, 2002 (Volume 67, Number 130)]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
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.
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
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
FDA welcomes the attendance of the public at its advisory committee
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