Ophthalmic Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting, 29763-29764 [E8-11451]
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Federal Register / Vol. 73, No. 100 / Thursday, May 22, 2008 / Notices
notify interested persons regarding their
request to speak by June 10, 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 John
Lauttman 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: May 15, 2008.
Randall W. Lutter,
Deputy Commissioner for Policy.
[FR Doc. E8–11449 Filed 5–21–08; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
Gastroenterology and Urology Devices
Panel of the Medical Devices Advisory
Committee; Notice of Meeting
AGENCY:
Food and Drug Administration,
HHS.
rwilkins on PROD1PC63 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: Gastroenterology
and Urology 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 June 25, 2008, from 8 a.m. to 5
p.m.
Location: Hilton Washington DC
North/Gaithersburg, Salons A, B, and C,
620 Perry Pkwy., Gaithersburg, MD.
Contact Person: Jeffrey Cooper, Center
for Devices and Radiological Health
(HFZ–470), Food and Drug
Administration, 9200 Corporate Blvd.,
Rockville, MD 20850, 240–276–4151 or
FDA Advisory Committee Information
VerDate Aug<31>2005
17:03 May 21, 2008
Jkt 214001
Line, 1–800–741–8138 (301–443–0572
in the Washington, DC area), code
3014512523. 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: The committee will discuss,
make recommendations, and vote on a
premarket approval application,
sponsored by Medical Enterprises, Ltd.,
for a drug/device combination product
designed to prevent recurrence of
bladder cancer. Synergo SB–3TS 101.1
Device with Mitomycin C is indicated
for use for prophylactic treatment of
recurrence in patients following
endoscopic removal of Ta-T1 and G1–3
superficial transitional cell carcinoma of
the bladder (STCCB). Ta-T1 refers to the
stage of the tumor, which is a measure
of how deep the tumor penetrates into
the bladder wall, with Ta and T1 being
the most superficial stages for raised
bladder tumors. G1–3 refers to the
tumor grade, which is a measure of how
aggressive the tumor is likely to grow,
with G1 being the least aggressive, and
G3 the most. Synergo and Mitomycin C
treatment is clinically indicated for
STCCB patients of intermediate and
high risk.
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 June 16, 2008. Oral
presentations from the public will be
scheduled between approximately 8:15
a.m. and 8:45 a.m., and between
approximately 2:45 p.m. and 3:15 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
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29763
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 June 6,
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 June 9, 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 Ann Marie
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: May 15, 2008.
Randall W. Lutter,
Deputy Commissioner for Policy.
[FR Doc. E8–11455 Filed 5–21–08; 8:45 am]
BILLING CODE 4160–01–S
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.
E:\FR\FM\22MYN1.SGM
22MYN1
29764
Federal Register / Vol. 73, No. 100 / Thursday, May 22, 2008 / Notices
rwilkins on PROD1PC63 with NOTICES
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 June 10, 2008, from 8 a.m. to
4:30 p.m.
Location: Hilton Washington DC
North/Gaithersburg, Salons A, B, and C,
620 Perry Pkwy., Gaithersburg, MD.
Contact Person: Karen F. Warburton,
Center for Devices and Radiological
Health (HFZ–460), 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: The committee will discuss
general issues concerning the
postmarket experience with various
contact lens care products. The
discussion will include
recommendations on contact lens care
product development topics such as
preclinical testing and clinical
performance measures, and labeling for
contact lenses and lens care products.
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
VerDate Aug<31>2005
17:03 May 21, 2008
Jkt 214001
before the committee. Written
submissions may be made to the contact
person on or before June 5, 2008. Oral
presentations from the public will be
scheduled on June 10, 2008, between
approximately 9:30 a.m. and 10 a.m.
and between approximately 3:30 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 May 28, 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 May 29, 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,
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).
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[FDA No. 225–08–2000]
Memorandum of Understanding With
the U.S. Army Corps of Engineers,
Mobile District
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) is providing
notice of a memorandum of
understanding (MOU) between FDA and
the U.S. Army Corps of Engineers,
Mobile District. This MOU establishes a
mutual framework governing the
respective responsibilities of the parties
for the provision of health services
through the Corps’ Regional
Occupational Health Center to FDA
employees at the FDA Gulf Coast
Seafood Laboratory. Goods and services
the Corps may provide include, but are
not limited to, physicals at ageappropriate intervals, referral of
employees to private physicians,
prevention programs related to health,
and other related goods and services as
meet the criteria and standards of the
Public Health Service, immunizations
for influenza and tetanus, and safety
and environmental counseling
DATES: The agreement became effective
April 28, 2008.
FOR FURTHER INFORMATION CONTACT: Julia
Pryor, Center for Food Safety and
Nutrition, rm. 122 (HFS–400), Food and
Drug Administration, P.O. Box 158, One
Iberville Dr., Dauphin Island, AL 36528,
251–694–4479.
SUPPLEMENTARY INFORMATION: In
accordance with 21 CFR 20.108(c),
which states that all written agreements
and MOUs between FDA and others
shall be published in the Federal
Register, the agency is publishing notice
of this MOU.
Dated: May 15, 2008.
Randall W. Lutter,
Deputy Commissioner for Policy.
[FR Doc. E8–11451 Filed 5–21–08; 8:45 am]
Dated: May 13, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and
Planning.
BILLING CODE 4160–01–S
BILLING CODE 4160–01–S
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]]>Agencies
[Federal Register Volume 73, Number 100 (Thursday, May 22, 2008)]
[Notices]
[Pages 29763-29764]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-11451]
-----------------------------------------------------------------------
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.
[[Page 29764]]
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 June 10, 2008, from 8
a.m. to 4:30 p.m.
Location: Hilton Washington DC North/Gaithersburg, Salons A, B, and
C, 620 Perry Pkwy., Gaithersburg, MD.
Contact Person: Karen F. Warburton, Center for Devices and
Radiological Health (HFZ-460), 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: The committee will discuss general issues concerning the
postmarket experience with various contact lens care products. The
discussion will include recommendations on contact lens care product
development topics such as preclinical testing and clinical performance
measures, and labeling for contact lenses and lens care products.
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 June
5, 2008. Oral presentations from the public will be scheduled on June
10, 2008, between approximately 9:30 a.m. and 10 a.m. and between
approximately 3:30 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 May 28, 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 May 29,
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, 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: May 15, 2008.
Randall W. Lutter,
Deputy Commissioner for Policy.
[FR Doc. E8-11451 Filed 5-21-08; 8:45 am]
BILLING CODE 4160-01-S
