Ophthalmic Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting, 15530 [E8-5810]
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Federal Register / Vol. 73, No. 57 / Monday, March 24, 2008 / Notices
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[FR Doc. E8–5761 Filed 3–21–08; 8:45 am]
BILLING CODE 4184–01–P
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.
mstockstill on PROD1PC66 with NOTICES
ACTION:
Notice.
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 April 24 and 25, 2008, from
8:30 a.m. to 5 p.m.
VerDate Aug<31>2005
16:33 Mar 21, 2008
Jkt 214001
Location: Gaithersburg Holiday Inn,
Ballroom, 2 Montgomery Village Ave.,
Gaithersburg, MD.
Contact Person: Karen F. Warburton,
Center for Devices and Radiological
Health, Food and Drug Administration,
9200 Corporate Blvd., Rockville, MD
20850, 240–276–4238, 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. A notice in the Federal
Register about last minute modifications
that impact a previously announced
advisory committee meeting cannot
always be published quickly enough to
provide timely notice. Therefore, you
should always check the agency’s Web
site and call the appropriate advisory
committee hot line/phone line to learn
about possible modifications before
coming to the meeting.
Agenda: On April 24, 2008, the
committee will discuss, make
recommendations, and vote on a
premarket approval application,
sponsored by VisionCare Technologies,
Inc., for an implantable miniature
telescope (IMT). The IMT, a visual
prosthetic device, is indicated for
monocular implant in patients with
stable, moderate to profound central
vision impairment due to bilateral
central scotomas associated with endstage macular degeneration with
geographic atrophy or disciform scar,
foveal involvement, and cataract. On
April 25, 2008, the committee will
discuss general issues concerning the
post market experience with phakic
intraocular lenses and laser-assisted in
situ keratomileusis (LASIK).
FDA intends to make background
material available to the public no later
than 2 business days before the meeting.
If FDA is unable to post the background
material on its Web site prior to the
meeting, the background material will
be made publicly available at the
location of the advisory committee
meeting, and the background material
will be posted on FDA’s Web site after
the meeting. Background material is
available at https://www.fda.gov/ohrms/
dockets/ac/acmenu.htm, click on the
year 2008 and scroll down to the
appropriate advisory committee link.
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 on or before April 15, 2008. Oral
presentations from the public will be
scheduled on April 24, 2008, between
approximately 9:30 a.m. and 10 a.m.
and between approximately 3:30 p.m.
PO 00000
Frm 00058
Fmt 4703
Sfmt 4703
and 4 p.m.; and on April 25, 2008,
between approximately 10 a.m. and
11:15 a.m. and between approximately 3
p.m. and 4 p.m. Those desiring to make
formal oral presentations should notify
the contact person 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 on
or before April 7, 2008. Time allotted for
each presentation may be limited. If the
number of registrants requesting to
speak is greater than can be reasonably
accommodated during the scheduled
open public hearing session, FDA may
conduct a lottery to determine the
speakers for the scheduled open public
hearing session. The contact person will
notify interested persons regarding their
request to speak by April 8, 2008.
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 240–276–8932, at least 7 days in
advance of the meeting.
FDA is committed to the orderly
conduct of its advisory committee
meetings. Please visit our Web site at
https://www.fda.gov/oc/advisory/
default.htm for procedures on public
conduct during advisory committee
meetings.
Notice of this meeting is given under
the Federal Advisory Committee Act (5
U.S.C. app. 2).
Dated: March 14, 2008.
Randall W. Lutter,
Deputy Commissioner for Policy.
[FR Doc. E8–5810 Filed 3–21–08; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Proposed Collection; Comment
Request; Inventory and Evaluation of
Clinical Research Networks
SUMMARY: In compliance with the
requirement of Section 3506(c)(2)(A) of
the Paperwork Reduction Act of 1995,
for opportunity for public comment on
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E:\FR\FM\24MRN1.SGM
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]]>Agencies
[Federal Register Volume 73, Number 57 (Monday, March 24, 2008)]
[Notices]
[Page 15530]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-5810]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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 April 24 and 25, 2008,
from 8:30 a.m. to 5 p.m.
Location: Gaithersburg Holiday Inn, Ballroom, 2 Montgomery Village
Ave., Gaithersburg, MD.
Contact Person: Karen F. Warburton, Center for Devices and
Radiological Health, Food and Drug Administration, 9200 Corporate
Blvd., Rockville, MD 20850, 240-276-4238, 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. A notice in the Federal Register about
last minute modifications that impact a previously announced advisory
committee meeting cannot always be published quickly enough to provide
timely notice. Therefore, you should always check the agency's Web site
and call the appropriate advisory committee hot line/phone line to
learn about possible modifications before coming to the meeting.
Agenda: On April 24, 2008, the committee will discuss, make
recommendations, and vote on a premarket approval application,
sponsored by VisionCare Technologies, Inc., for an implantable
miniature telescope (IMT). The IMT, a visual prosthetic device, is
indicated for monocular implant in patients with stable, moderate to
profound central vision impairment due to bilateral central scotomas
associated with end-stage macular degeneration with geographic atrophy
or disciform scar, foveal involvement, and cataract. On April 25, 2008,
the committee will discuss general issues concerning the post market
experience with phakic intraocular lenses and laser-assisted in situ
keratomileusis (LASIK).
FDA intends to make background material available to the public no
later than 2 business days before the meeting. If FDA is unable to post
the background material on its Web site prior to the meeting, the
background material will be made publicly available at the location of
the advisory committee meeting, and the background material will be
posted on FDA's Web site after the meeting. Background material is
available at https://www.fda.gov/ohrms/dockets/ac/acmenu.htm, click on
the year 2008 and scroll down to the appropriate advisory committee
link.
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 on or before
April 15, 2008. Oral presentations from the public will be scheduled on
April 24, 2008, between approximately 9:30 a.m. and 10 a.m. and between
approximately 3:30 p.m. and 4 p.m.; and on April 25, 2008, between
approximately 10 a.m. and 11:15 a.m. and between approximately 3 p.m.
and 4 p.m. Those desiring to make formal oral presentations should
notify the contact person 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 on or before
April 7, 2008. Time allotted for each presentation may be limited. If
the number of registrants requesting to speak is greater than can be
reasonably accommodated during the scheduled open public hearing
session, FDA may conduct a lottery to determine the speakers for the
scheduled open public hearing session. The contact person will notify
interested persons regarding their request to speak by April 8, 2008.
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 240-276-8932, at least 7 days in
advance of the meeting.
FDA is committed to the orderly conduct of its advisory committee
meetings. Please visit our Web site at https://www.fda.gov/oc/advisory/
default.htm for procedures on public conduct during advisory committee
meetings.
Notice of this meeting is given under the Federal Advisory
Committee Act (5 U.S.C. app. 2).
Dated: March 14, 2008.
Randall W. Lutter,
Deputy Commissioner for Policy.
[FR Doc. E8-5810 Filed 3-21-08; 8:45 am]
BILLING CODE 4160-01-S
