[Federal Register Volume 64, Number 239 (Tuesday, December 14, 1999)]
[Notices]
[Page 69774]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-32242]
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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 January 13, 2000, 9:30
a.m. to 5 p.m., and January 14, 2000, 9:30 a.m. to 2 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: On January 13, 2000, the committee will discuss, make
recommendations, and vote on a premarket approval application (PMA) for
a holmium laser for the correction of hyperopia using laser thermal
keratomileusis. On January 14, 2000, the committee will discuss and
make recommendations on: (1) The reclassification of an artificial eye
lubricating solution, and (2) the classification status for currently
unclassified eyelid weight devices.
Procedure: On January 13, 2000, from 9:30 a.m. to 3 p.m., and on
January 14, 2000, from 9:30 to 2 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 January 6, 2000. On
January 13, 2000, formal oral presentations from the public will be
scheduled between approximately 9:45 a.m. and 10:15 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 January 14, 2000,
oral presentations from the public regarding the reclassification of
the artificial eye lubricating solution and the classification of the
eyelid weight devices will be scheduled between approximately 9:45 a.m.
to 10:45 a.m. Those desiring to make formal oral presentations should
notify the contact person by January 6, 2000, 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 January 13, 2000, from 3 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)) regarding pending issues and applications.
Notice of this meeting is given under the Federal Advisory
Committee Act (5 U.S.C. app. 2).
Dated: December 7, 1999.
Linda A. Suydam,
Senior Associate Commissioner.
[FR Doc. 99-32242 Filed 12-13-99; 8:45 am]
BILLING CODE 4160-01-F
