[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