Gastroenterology and Urology Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting, 57968 [2010-23842]
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57968
Federal Register / Vol. 75, No. 184 / Thursday, September 23, 2010 / Notices
invasion of personal privacy (5 U.S.C.
552b(c)(6)). This portion of the meeting
will be closed to permit discussion of
information concerning individuals
associated with the research programs at
NCTR.
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 Margaret
Miller 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/Advisory
Committees/AboutAdvisoryCommittees/
ucm111462.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: September 17, 2010.
Jill Hartzler Warner,
Acting Associate Commissioner for Special
Medical Programs.
[FR Doc. 2010–23843 Filed 9–22–10; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2010–N–0001]
Gastroenterology and Urology Devices
Panel of the Medical Devices Advisory
Committee; Notice of Meeting
AGENCY:
Food and Drug Administration,
HHS.
srobinson on DSKHWCL6B1PROD 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 December 2 and 3, 2010, from
8 a.m. to 6 p.m.
VerDate Mar<15>2010
16:52 Sep 22, 2010
Jkt 220001
Location: Hilton Washington DC
North/Gaithersburg, Ballroom, 620 Perry
Pkwy., Gaithersburg, MD.
Contact Person: Margaret McCabeJanicki, Food and Drug Administration,
Center for Devices and Radiological
Health, 10903 New Hampshire Ave.,
Bldg. 66, rm. 1535, Silver Spring, MD
20993–0002, 301–796–7029, or FDA
Advisory Committee Information 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: On December 2, 2010, the
committee will discuss, make
recommendations, and vote on
information related to the premarket
approval application (PMA) for
SOLESTA, sponsored by Oceana
Therapeutics, Inc. SOLESTA is
indicated for the treatment of fecal
incontinence in patients who have
failed conservative therapy. On
December 3, 2010, the committee will
discuss, make recommendations, and
vote on information related to the PMA
for the LAP-BAND Adjustable Gastric
Banding System, sponsored by Allergan.
The sponsor is requesting an expanded
Indication for Use for their LAP-BAND
Adjustable Gastric Banding System to
include weight reduction in patients
with a Body Mass Index (BMI) of at least
35 kg/m2 or a BMI of at least 30 kg/m2
with one or more comorbid conditions.
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/
AdvisoryCommittees/Calendar/
default.htm. 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 November 18, 2010.
Oral presentations from the public will
PO 00000
Frm 00082
Fmt 4703
Sfmt 4703
be scheduled between approximately 1
p.m. and 2 p.m. on December 2 and 3,
2010. 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 November 10, 2010. 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
November 11, 2010.
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, 301–796–5966, 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/
AdvisoryCommittees/AboutAdvisory
Committees/ucm111462.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: September 17, 2010.
Jill Hartzler Warner,
Acting Associate Commissioner for Special
Medical Programs.
[FR Doc. 2010–23842 Filed 9–22–10; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Eye Institute; Notice of Closed
Meeting
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. App), notice is
hereby given of the following meeting.
E:\FR\FM\23SEN1.SGM
23SEN1
]]>Agencies
[Federal Register Volume 75, Number 184 (Thursday, September 23, 2010)]
[Notices]
[Page 57968]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-23842]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2010-N-0001]
Gastroenterology and Urology 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: 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 December 2 and 3, 2010,
from 8 a.m. to 6 p.m.
Location: Hilton Washington DC North/Gaithersburg, Ballroom, 620
Perry Pkwy., Gaithersburg, MD.
Contact Person: Margaret McCabe-Janicki, Food and Drug
Administration, Center for Devices and Radiological Health, 10903 New
Hampshire Ave., Bldg. 66, rm. 1535, Silver Spring, MD 20993-0002, 301-
796-7029, or FDA Advisory Committee Information 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: On December 2, 2010, the committee will discuss, make
recommendations, and vote on information related to the premarket
approval application (PMA) for SOLESTA, sponsored by Oceana
Therapeutics, Inc. SOLESTA is indicated for the treatment of fecal
incontinence in patients who have failed conservative therapy. On
December 3, 2010, the committee will discuss, make recommendations, and
vote on information related to the PMA for the LAP-BAND Adjustable
Gastric Banding System, sponsored by Allergan. The sponsor is
requesting an expanded Indication for Use for their LAP-BAND Adjustable
Gastric Banding System to include weight reduction in patients with a
Body Mass Index (BMI) of at least 35 kg/m\2\ or a BMI of at least 30
kg/m\2\ with one or more comorbid conditions.
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/AdvisoryCommittees/Calendar/default.htm. 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
November 18, 2010. Oral presentations from the public will be scheduled
between approximately 1 p.m. and 2 p.m. on December 2 and 3, 2010.
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 November 10, 2010.
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 November 11, 2010.
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, 301-796-5966, 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/AdvisoryCommittees/AboutAdvisoryCommittees/ucm111462.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: September 17, 2010.
Jill Hartzler Warner,
Acting Associate Commissioner for Special Medical Programs.
[FR Doc. 2010-23842 Filed 9-22-10; 8:45 am]
BILLING CODE 4160-01-S
