[Federal Register: February 17, 2004 (Volume 69, Number 31)]
[Notices]
[Page 7490]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr17fe04-95]
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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). 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's regulatory issues.
Date and Time: The meeting will be held on March 5, 2004, from 9
a.m. to 4 p.m.
Location: Hilton Washington DC North/Gaithersburg, Salons A and B,
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, 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 Information
Line for up-to-date information on this meeting.
Agenda: The committee will discuss general issues surrounding the
use of intraocular lenses for correction of presbyopia after clear lens
extraction. The committee will address clinical study design elements
including the risk/benefit ratio for patients with various refractive
errors, study sample size, the need for control groups, inclusion/
exclusion criteria, and the incidence of retinal detachment and other
complications. Background information, 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://www.fda.gov/cdrh/panelmtg.html
.
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 February 24,
2004. On March 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 discussion a second 30-minute open public session will
be conducted for interested persons to comment further on the
discussion topic. Time allotted for each presentation may be limited.
Those desiring to make formal oral presentations should notify the
contact person before February 24, 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.
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 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: February 9, 2004.
Peter J. Pitts,
Associate Commissioner for External Relations.
[FR Doc. 04-3334 Filed 2-13-04; 8:45 am]
BILLING CODE 4160-01-S