[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