[Federal Register: January 13, 2004 (Volume 69, Number 8)]
[Notices]               
[Page 1987-1988]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr13ja04-53]                         

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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 February 5, 2004, from 9 
a.m. to 5 p.m., and February 6, 2004, from 8 a.m. to 4:30 p.m.
    Location: Gaithersburg Marriott, Salons A, B, C, and D, 9751 
Washingtonian Blvd., 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, ext. 127, or FDA 
Advisory Committee Information Line, 1-800-741-8138 (301-443-0572 in 
the Washington, DC area), code 3014512396. Please call the

[[Page 1988]]

Information Line for up-to-date information on this meeting.
    Agenda: On February 5, 2004, the committee will discuss, make 
recommendations, and vote on a premarket approval application (PMA) for 
a phakic intraocular lens for the reduction or elimination of myopia in 
adults.
    On February 6, 2004, the committee will discuss, make 
recommendations and vote on a PMA for a radiofrequency electrosurgical 
corneal shaping device for the temporary treatment of presbyopia. 
Background information for each day's topic, including the attendee 
list, agenda, and questions for the committee, will be available to the 
public 1 business day before the meeting, on the Internet at http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/cdrh/panelmtg.html.
 Material for the February 5, 2004, 

session will be posted on February 4, 2004; material for the February 
6, 2004, session will be posted on February 5, 2004.
    Procedure: On February 5, 2004, from 9 a.m. to 5 p.m., and on 
February 6, 2004, from 9:30 a.m. to 4:30 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 26, 2004. On 
February 5, 2004, formal oral presentations from the public will be 
scheduled between approximately 9:15 a.m. and 9:45 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 February 6, 2004, oral 
presentations from the public will be scheduled between approximately 
9:45 a.m. and 10:15 a.m. Near the end of 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. Time allotted for each presentation may be limited. Those 
desiring to make formal oral presentations should notify the contact 
person before January 26, 2004, 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 February 6, 2004, from 8 a.m. to 
9:30 a.m., the meeting will be closed to permit FDA staff to present to 
the committee trade secret and/or confidential commercial information 
relevant to pending and future device submissions for vitreoretinal, 
surgical and diagnostic devices, intraocular and corneal implants, and 
contact lenses. This portion of the meeting will be closed to permit 
discussion of this information (5 U.S.C. 552b(c)(4)).
    Persons attending FDA's advisory committee meetings are advised 
that the agency is not responsible for providing access to electrical 
outlets.
    FDA welcomes the attendance of the public at its advisory committee 
meetings and will make every effort to accommodate persons with 
physical disabilities or special needs. If you require special 
accommodations due to a disability, please contact AnnMarie Williams, 
Conference Management Staff, at 301-594-1283, ext. 113, at least 7 days 
in advance of the meeting.
    Notice of this meeting is given under the Federal Advisory 
Committee Act (5 U.S.C. app. 2).

    Dated: January 5, 2004.
Peter J. Pitts,
Associate Commissioner for External Relations.
[FR Doc. 04-601 Filed 1-12-04; 8:45 am]

BILLING CODE 4160-01-S