[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]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration


Advisory Committee; Notice of Meeting

AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.

-----------------------------------------------------------------------

[[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