[Federal Register Volume 63, Number 192 (Monday, October 5, 1998)]
[Notices]
[Page 53445]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-26572]
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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 October 22, 1998, 10:30
a.m. to 5:30 p.m., and October 23, 1998, 9 a.m. to 5 p.m.
Location: Holiday Inn Silver Spring, 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 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 October 22, 1998, the committee will discuss issues
related to the development of extensions to the guidance document for
refractive surgical lasers, entitled ``Discussion Points for Expansion
of the Checklist of Information Usually Submitted in an Investigational
Device Exemption (IDE) Application for Refractive Surgery Lasers'' to
include the clinical criteria for the determination of safety and
effectiveness for photorefractive keratectomy (PRK) and laser in-situ
keratomileusis (LASIK) for myopia and hyperopia with and without
astigmatism, presbyopia, and other refractive indications. Single
copies of the guidance document are available to the public by
contacting the Division of Small Manufacturers Assistance, Center for
Devices and Radiological Health, Food and Drug Administration, 5600
Fishers Lane, Rockville, MD 20857, 1-800-638-2041 or 301-443-6597 and
requesting the document by shelf number 093, or by FAX 1-800-899-0381
or 301-827-0111 and requesting facts-on-demand number 2093, or on the
Internet using the World Wide Web (WWW) (http://www.fda.gov/cdrh/ode/
ed__op.html). On October 23, 1998, the committee will discuss issues
related to the preliminary development of guidance for refractive
implants (phakic intraocular lenses and corneal implants) to include
clinical protocol design and development.
Procedure: On October 22, 1998, from 1:30 p.m. to 5:30 p.m., and on
October 23, 1998, from 9 a.m. to 5 p.m., the meeting will be 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 October 15, 1998. Oral
presentations from the public will be scheduled between approximately
1:30 p.m. and 2 p.m. on October 22, 1998 and between approximately 9
a.m. and 9:30 a.m. on October 23, 1998. Time allotted for each
presentation may be limited. Those desiring to make formal oral
presentations should notify the contact person before October 15, 1998,
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 October 22, 1998, from 10:30
a.m. to 1:30 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: September 24, 1998.
Michael A. Friedman,
Deputy Commissioner for Operations.
[FR Doc. 98-26572 Filed 10-2-98; 8:45 am]
BILLING CODE 4160-01-F
