Neurological Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting, 68788-68789 [2012-27934]
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68788
Federal Register / Vol. 77, No. 222 / Friday, November 16, 2012 / Notices
TABLE 2—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN 1
Type of submission
Number of
respondents
Annual frequency
per disclosure
Total annual
disclosures
Hours per
disclosure
Total hours
Post approved labeling on application holder’s
Web site .......................................................
197
1
197
4
788
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
This draft guidance also refers to
previously approved collections of
information. Specifically, the draft
guidance describes: Labeling
supplements for new drug applications,
abbreviated new drug applications, and
biologics license applications submitted
under 21 CFR 314.70, 314.71, 314.97,
and 601.12, and the content and format
of prescription drug labeling submitted
under 21 CFR 201.56 and 201.57. These
collections of information are subject to
review by OMB under the PRA and are
approved under OMB control numbers
0910–0001, 0910–0338, and 0910–0572.
Section V of the draft guidance refers to
the guidance entitled ‘‘Formal Dispute
Resolution: Appeals Above the Division
Level,’’ which describes collections of
information approved under OMB
control number 0910–0430.
Dated: November 9, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012–27881 Filed 11–15–12; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2012–N–0001]
Neurological Devices Panel of the
Medical Devices Advisory Committee;
Notice of Meeting
AGENCY:
Food and Drug Administration,
HHS.
mstockstill on DSK4VPTVN1PROD 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. This meeting is being
rescheduled due to the postponement of
the November 1, 2012, meeting due to
unanticipated weather conditions
caused by hurricane Sandy.
Name of Committee: Neurological
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.
VerDate Mar<15>2010
15:43 Nov 15, 2012
Jkt 229001
Date and Time: The meeting will be
held on December 10, 2012, from 8 a.m.
to 6 p.m.
Location: Hilton Washington DC
North/Gaithersburg, 620 Perry Pkwy.,
Grand Ballroom, Gaithersburg, MD
20877. The hotel’s telephone number is
301–977–8900.
Contact Person: Natasha Facey, Center
for Devices and Radiological Health,
Food and Drug Administration, 10903
New Hampshire Ave., Bldg. 66, rm.
1544, Silver Spring, MD 20993–0002,
301–796–5290,
Natasha.Facey@fda.hhs.gov or FDA
Advisory Committee Information Line,
1–800–741–8138 (301–443–0572 in the
Washington, DC area). 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 at https://
www.fda.gov/AdvisoryCommittees/
default.htm and scroll down to the
appropriate advisory committee meeting
link, or call the advisory committee
information line to learn about possible
modifications before coming to the
meeting.
Agenda: On December 10, 2012, the
committee will discuss current
knowledge about the safety and
effectiveness of the CoAxia NeuroFlo
Catheter device for the intended use of
diverting cardiac output to the cerebral
vasculature via partial occlusion of the
descending aorta, including in patients
with acute ischemic stroke within 14
hours of symptom onset.
The CoAxia NeuroFlo Catheter is a 7F
multilumen device with two balloons
mounted near the distal tip. The
proximal end has a multiport manifold
that provides access for the guidewire,
monitoring of blood pressure, and
independent inflation of the individual
balloons. The device is placed in the
descending aorta. On March 30, 2005, a
humanitarian device exemption
application for the CoAxia NeuroFlo
Catheter was approved for the following
indication for use: The CoAxia
NeuroFlo Catheter is intended for the
treatment of cerebral ischemia resulting
from symptomatic vasospasm following
aneurismal subarachnoid hemorrhage,
PO 00000
Frm 00058
Fmt 4703
Sfmt 4703
secured by either surgical or
endovascular intervention for patients
who have failed maximal medical
management.
Of note, the CoAxia NeuroFlo
Catheter is identical in design to the
CoAxia FloControl, which is currently
cleared for the following general
indications for use:
1. The CoAxia FloControl Catheter is
intended for use in selectively stopping
or controlling flow in the peripheral
vasculature (K023914).
2. The CoAxia FloControl Catheter is
intended for use in selectively stopping
or controlling flow in the peripheral
vasculature, which includes the
descending aorta (K090970).
CoAxia has submitted a de novo
application for the NeuroFlo for the
following indication: The CoAxia
NeuroFlo Catheter is intended for use in
diversion of cardiac output via partial
occlusion of the descending aorta,
including patients with acute ischemic
stroke within 14 hours of symptom
onset. The CoAxia NeuroFlo Catheter is
also intended for use in selectively
stopping or controlling blood flow in
the peripheral vasculature, which
includes the descending aorta.
FDA is convening this committee to
seek expert scientific and clinical
opinion on the risks and benefits of this
device based on the available premarket
and postmarket data. In particular, the
committee will be asked to discuss the
safety and effectiveness data from the
‘‘Safety and Efficacy of NeuroFlo
Technology in Ischemic Stroke’’
(SENTIS) clinical trial as they relate to
the proposed indications for use.
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 meeting
link.
E:\FR\FM\16NON1.SGM
16NON1
Federal Register / Vol. 77, No. 222 / Friday, November 16, 2012 / Notices
mstockstill on DSK4VPTVN1PROD with NOTICES
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 December 4, 2012.
Oral presentations from the public will
be scheduled between approximately 1
p.m. and 2 p.m. Those individuals
interested in making 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 26, 2012. 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 28, 2012.
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, Committee 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: November 13, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012–27934 Filed 11–15–12; 8:45 am]
BILLING CODE 4160–01–P
VerDate Mar<15>2010
15:43 Nov 15, 2012
Jkt 229001
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2012–N–1037]
Establishing a List of Qualifying
Pathogens That Have the Potential To
Pose a Serious Threat to Public Health;
Public Hearing; Request for Comments
AGENCY:
Food and Drug Administration,
HHS.
Notice of public hearing; request
for comments.
ACTION:
The Food and Drug
Administration (FDA) is announcing a
public hearing to obtain input on
establishing a list of qualifying
pathogens (i.e., those that have the
potential to pose a serious threat to
public health), as required under the
Food and Drug Administration Safety
and Innovation Act (FDASIA). This
public hearing is being held to obtain
comments from the public to determine
the methodology that should be used in
developing the list of qualifying
pathogens, and to elicit suggestions for
adding specific pathogens to the list.
DATES: Date and Time: The public
hearing will be held on December 18,
2012, from 9 a.m. to 5 p.m. However,
depending on the level of public
participation, the hearing may be
extended or may end early.
Location: The public hearing will be
held at FDA’s White Oak Campus,
10903 New Hampshire Ave., Bldg. 31,
the Great Room (rm. 1503), Silver
Spring, MD 20993. Entrance for the
public meeting participants (non-FDA
employees) is through Building 1 where
routine security check procedures will
be performed. For parking and security
information, please refer to https://
www.fda.gov/AboutFDA/
WorkingatFDA/BuildingsandFacilities/
WhiteOakCampusInformation/
ucm241740.htm.
Contact Person: Lee Lemley, Center
for Drug Evaluation and Research, Food
and Drug Administration, 10903 New
Hampshire Ave., Silver Spring, MD
20993, 301–796–7563, FAX: 301–847–
8753, email: CDER–
GAINPublicMtg@fda.hhs.gov.
Registration: The public hearing is
free and seating will be on a first-come,
first-served basis. Attendees who do not
wish to make an oral presentation do
not need to register.
If you need special accommodations
due to a disability, please contact Lee
Lemley (see Contact Person) at least 7
days in advance.
Requests for Oral Presentations: If you
wish to make an oral presentation
SUMMARY:
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68789
during the public hearing, you must
register by submitting either an
electronic or written request by close of
business on December 3, 2012. You
must provide your name, title, business
affiliation (if applicable), address, email
address, and phone and type of
organization you represent (e.g.,
industry, consumer organization), and a
brief summary of the presentation
(including the discussion topic(s) that
will be addressed) to Lee Lemley (see
Contact Person). You should identify
which question(s) set forth in section II
of this document you wish to address so
that FDA can consider that in organizing
the presentations.
FDA will notify registered presenters
of their scheduled times, and will make
available an agenda at https://
www.fda.gov/Drugs/NewsEvents/
ucm319619.htm. Once FDA notifies
registered presenters of their scheduled
times, presenters should submit an
electronic copy of their presentation to
Lee Lemley (see Contact Person) no later
than December 12, 2012. Persons
registered to make an oral presentation
should check in before the hearing, and
are encouraged to arrive early to ensure
the designated order of presentation.
A live Webcast of this public hearing
will be viewable at the following Web
site: https://collaboration.fda.gov/
gain121812/. A video record of the
public hearing will be available at the
same Web site for 1 year.
Comments: Regardless of attendance
at the public hearing, interested persons
may submit either written comments to
the Division of Dockets Management
(HFA–305), Food and Drug
Administration, 5630 Fishers Lane, rm.
1061, Rockville, MD 20852 or electronic
comments to https://
www.regulations.gov. Submit electronic
or written comments by December 3,
2012. You should annotate and organize
your comments so that they identify the
specific questions to which they refer. It
is only necessary to send one set of
comments. Identify comments with the
docket number found in brackets in the
heading of this document. Received
comments may be seen in the Division
of Dockets Management between 9 a.m.
and 4 p.m., Monday through Friday, and
will be posted to the docket at https://
www.regulations.gov.
To permit time for all interested
persons to submit data, information, or
views on this subject, the administrative
record of the hearing will remain open
until January 25, 2013.
Transcripts: Please be advised that as
soon as a transcript is available, it will
be accessible at https://
www.regulations.gov. It may be viewed
at the Division of Dockets Management
E:\FR\FM\16NON1.SGM
16NON1
]]>Agencies
[Federal Register Volume 77, Number 222 (Friday, November 16, 2012)]
[Notices]
[Pages 68788-68789]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-27934]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2012-N-0001]
Neurological 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. This meeting is being rescheduled due to the
postponement of the November 1, 2012, meeting due to unanticipated
weather conditions caused by hurricane Sandy.
Name of Committee: Neurological 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 10, 2012, from
8 a.m. to 6 p.m.
Location: Hilton Washington DC North/Gaithersburg, 620 Perry Pkwy.,
Grand Ballroom, Gaithersburg, MD 20877. The hotel's telephone number is
301-977-8900.
Contact Person: Natasha Facey, Center for Devices and Radiological
Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
66, rm. 1544, Silver Spring, MD 20993-0002, 301-796-5290,
Natasha.Facey@fda.hhs.gov or FDA Advisory Committee Information Line,
1-800-741-8138 (301-443-0572 in the Washington, DC area). 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 at https://www.fda.gov/AdvisoryCommittees/default.htm and scroll down to the appropriate
advisory committee meeting link, or call the advisory committee
information line to learn about possible modifications before coming to
the meeting.
Agenda: On December 10, 2012, the committee will discuss current
knowledge about the safety and effectiveness of the CoAxia NeuroFlo
Catheter device for the intended use of diverting cardiac output to the
cerebral vasculature via partial occlusion of the descending aorta,
including in patients with acute ischemic stroke within 14 hours of
symptom onset.
The CoAxia NeuroFlo Catheter is a 7F multilumen device with two
balloons mounted near the distal tip. The proximal end has a multiport
manifold that provides access for the guidewire, monitoring of blood
pressure, and independent inflation of the individual balloons. The
device is placed in the descending aorta. On March 30, 2005, a
humanitarian device exemption application for the CoAxia NeuroFlo
Catheter was approved for the following indication for use: The CoAxia
NeuroFlo Catheter is intended for the treatment of cerebral ischemia
resulting from symptomatic vasospasm following aneurismal subarachnoid
hemorrhage, secured by either surgical or endovascular intervention for
patients who have failed maximal medical management.
Of note, the CoAxia NeuroFlo Catheter is identical in design to the
CoAxia FloControl, which is currently cleared for the following general
indications for use:
1. The CoAxia FloControl Catheter is intended for use in
selectively stopping or controlling flow in the peripheral vasculature
(K023914).
2. The CoAxia FloControl Catheter is intended for use in
selectively stopping or controlling flow in the peripheral vasculature,
which includes the descending aorta (K090970).
CoAxia has submitted a de novo application for the NeuroFlo for the
following indication: The CoAxia NeuroFlo Catheter is intended for use
in diversion of cardiac output via partial occlusion of the descending
aorta, including patients with acute ischemic stroke within 14 hours of
symptom onset. The CoAxia NeuroFlo Catheter is also intended for use in
selectively stopping or controlling blood flow in the peripheral
vasculature, which includes the descending aorta.
FDA is convening this committee to seek expert scientific and
clinical opinion on the risks and benefits of this device based on the
available premarket and postmarket data. In particular, the committee
will be asked to discuss the safety and effectiveness data from the
``Safety and Efficacy of NeuroFlo Technology in Ischemic Stroke''
(SENTIS) clinical trial as they relate to the proposed indications for
use.
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 meeting
link.
[[Page 68789]]
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
December 4, 2012. Oral presentations from the public will be scheduled
between approximately 1 p.m. and 2 p.m. Those individuals interested in
making 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 26, 2012. 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 28, 2012.
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,
Committee 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: November 13, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012-27934 Filed 11-15-12; 8:45 am]
BILLING CODE 4160-01-P
