[Federal Register Volume 64, Number 168 (Tuesday, August 31, 1999)]
[Notices]
[Page 47509]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-22604]
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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). 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's regulatory issues.
Date and Time: The meeting will be held on September 23, 1999, 8:30
a.m. to 5 p.m.
Location: Holiday Inn, Lincoln Ballroom, 8777 Georgia Ave., Silver
Spring, 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 by e-mail at
smt@cdrh.fda.gov, 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 September 23, 1999, from 8:30 a.m. to 1:30 p.m., the
committee will hear formal presentations followed by public
participation in a discussion of keratomes. Public participants in the
group discussion are requested to develop a comprehensive list of
problems associated with keratomes, the related causes, and the steps
that can be taken to mitigate the problems. From 1:30 p.m. to 5 p.m.,
the committee will discuss issues related to defining the scope and
purpose of a proposed keratome guidance to be developed from an outline
of contents currently recommended for keratome premarket notification
submissions. Single copies of the outline are available to the public
by contacting the person noted above.
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 September 7,
1999. Formal oral presentations from the public will be scheduled
between approximately 9:15 a.m. and 10:15 a.m. on September 23, 1999.
Those desiring to make formal oral presentations should notify the
contact person before September 10, 1999, 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. Those desiring to be a participant in the open group
discussion should notify the contact person by September 10, 1999, to
reserve a place at a discussion table.
Notice of this meeting is given under the Federal Advisory
Committee Act (5 U.S.C. app. 2).
Dated: August 23, 1999.
Linda A. Suydam,
Senior Associate Commissioner.
[FR Doc. 99-22604 Filed 8-30-99; 8:45 am]
BILLING CODE 4160-01-F
