[Federal Register Volume 62, Number 119 (Friday, June 20, 1997)]
[Notices]
[Pages 33661-33662]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-16235]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Advisory Committee; Notice of Meeting
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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[[Page 33662]]
This notice announces a forthcoming meeting of a public advisory
committee of the Food and Drug Administration (FDA). The meeting will
be open 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 regulatory issues.
Date and Time: The meeting will be held on July 10 and 11, 1997, 8
a.m. to 5 p.m.
Location: Gaithersburg Hilton, Salons A, B, and C of the Ballroom,
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, or FDA Advisory
Committee Information Line, 1-800-741-8138 (301-443-0572 in the
Washington, DC area), code 12396, or the world wide web at http://
www.fda.gov. Please call the Information Line for up-to-date
information on this meeting.
Agenda: On July 10, 1997, there will be a presentation of the basic
concepts of FDA's Product Development Protocol Process with specific
focus on the implementation of the process within the Division of
Ophthalmic Devices. The committee will discuss issues relating to a
premarket approval application (PMA) for a monofocal intraocular lens
and a PMA for a multifocal intraocular lens for primary implantation
for the visual correction of aphakia. On July 11, 1997, the committee
will discuss issues relating to a PMA for an excimer laser for the
correction of myopia using laser in-situ keratomileusis (LASIK).
Procedure: 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 1, 1997.
Oral presentations from the public will be scheduled between
approximately 8 a.m. and 9 a.m. on July 10 and 11, 1997. Time allotted
for each presentation may be limited. Those desiring to make formal
presentations should notify the contact person before July 1, 1997, 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.
Notice of this meeting is given under the Federal Advisory
Committee Act (5 U.S.C. app. 2).
FDA regrets that it was unable to publish this notice 15 days prior
to the July 10 and 11, 1997, Ophthalmic Devices Panel of the Medical
Devices Advisory Committee meeting. Because the agency believes there
is some urgency to bring these issues to public discussion and
qualified members of the Ophthalmic Devices Panel of the Medical
Devices Advisory Committee were available at this time, the
Commissioner concluded that it was in the public interest to hold this
meeting even if there was not sufficient time for the customary 15-day
public notice.
Dated: June 12, 1997.
Michael A. Friedman,
Deputy Commissioner for Operations.
[FR Doc. 97-16235 Filed 6-19-97; 8:45 am]
BILLING CODE 4160-01-F
