Circulatory System Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting, 58019-58020 [2011-23875]
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Federal Register / Vol. 76, No. 181 / Monday, September 19, 2011 / Notices
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2011–N–0002]
Tobacco Products Scientific 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). At least one portion of the
meeting will be closed to the public.
Name of Committee: Tobacco
Products Scientific Advisory Committee
(TPSAC).
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 November 2, 2011, from 9 a.m.
to 5 p.m., and on November 3, 2011,
from 8 a.m. to 5 p.m.
Location: Center for Tobacco
Products, Food and Drug
Administration, 9200 Corporate Blvd.
rm. 020B, Rockville, MD 20850, 1–877–
287–1373.
Contact Person: Caryn Cohen, Center
for Tobacco Products, Food and Drug
Administration, 9200 Corporate Blvd.,
Rockville, MD 20850, 1–877–287–1373
(choose option 4), e-mail:
TPSAC@fda.hhs.gov, or FDA Advisory
Committee Information Line, 1–800–
741–8138 (301–443–0572 in the
Washington, DC area), and follow the
prompts to the desired center or product
area. 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 continue
the discussions of issues related to the
nature and impact of the use of
dissolvable tobacco products on the
public health, including such use
among children, as part of TPSAC’s
required report to the Secretary of
Health and Human Services. Discussion
will include such topics as the
composition and characteristics of
dissolvable tobacco products, product
VerDate Mar<15>2010
15:46 Sep 16, 2011
Jkt 223001
use, potential health effects, and
marketing.
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: On November 2, 2011,
from 1 p.m. to 5 p.m., and on November
3, from 8 a.m. to 5 p.m., the meeting is
open to the public. 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 October 19, 2011.
Oral presentations from the public will
be scheduled between approximately 11
a.m. and 12 noon on November 3, 2011.
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 October 11, 2011. 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
October 12, 2011.
Closed Committee Deliberations: On
November 2, 2011, from 9 a.m. to 12
noon, the meeting will be closed to
permit discussion and review of trade
secret and/or confidential commercial
information (5 U.S.C. 552b(c)(4)). This
portion of the meeting must be closed
because the committee will be
discussing trade secret and/or
confidential data provided by the
tobacco companies regarding
dissolvable tobacco products.
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
PO 00000
Frm 00073
Fmt 4703
Sfmt 4703
58019
accommodate persons with physical
disabilities or special needs. If you
require special accommodations due to
a disability, please contact Caryn Cohen
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 13, 2011.
Jill Hartzler Warner,
Acting Associate Commissioner for Special
Medical Programs.
[FR Doc. 2011–23868 Filed 9–16–11; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2011–N–0002]
Circulatory System 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: Circulatory
System 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 October 26 and 27, 2011, from
8 a.m. to 6 p.m.
Location: Hilton Washington, DC,
North/Gaithersburg, salons A, B, C, and
D, 620 Perry Pkwy., Gaithersburg, MD.
Contact Person: James Swink, Center
for Devices and Radiological Health,
Food and Drug Administration, 10903
New Hampshire Ave., Silver Spring, MD
20993, e-mail:
james.swink@fda.hhs.gov, or FDA
Advisory Committee Information Line,
1–800–741–8138 (301–443–0572 in the
Washington, DC area), and follow the
prompts to the desired center or product
area. Please call the Information Line for
E:\FR\FM\19SEN1.SGM
19SEN1
mstockstill on DSK4VPTVN1PROD with NOTICES
58020
Federal Register / Vol. 76, No. 181 / Monday, September 19, 2011 / Notices
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 October 26, 2011, the
committee will discuss, make
recommendations, and vote on
information related to the premarket
approval application sponsored by
AtriCure, Inc., for the AtriCure Synergy
Ablation System to be used for the
treatment of atrial fibrillation in patients
who are undergoing open concomitant
cardiac surgery. The AtriCure Synergy
Ablation System consists of the
following:
• The AtriCure Isolator Synergy
Handpieces (models OLL2 and OSL2),
which resemble surgical clamps,
include a syringe-type grip handle/
actuator, connected by a cylindrical
shaft to a pair of grasping jaws with
electrodes on each jaw. The electrodes
deliver radiofrequency (RF) energy to
the tissue grasped by the jaws.
• The Ablation and Sensing Unit is
an RF generator used to power the
Isolator Synergy Handpieces.
• The Isolator Switch Matrix is an
accessory interface module allowing the
Isolator Synergy Handpieces to connect
to the RF generator.
On October 27, 2011, the committee
will discuss, make recommendations,
and vote on information related to the
premarket approval application for the
Medtronic Ablation Frontiers Cardiac
Ablation System sponsored by
Medtronic, Inc. The Medtronic Ablation
Frontiers Cardiac Ablation System is a
catheter-based device developed for the
treatment of atrial fibrillation. The
system consists of the following:
• The Pulmonary Vein Ablation
Catheter, which is designed to create
lesions in the left atrium via five pairs
of electrodes to isolate the pulmonary
veins. It has a deflectable distal end and
bidirectional steering to aid in
positioning the catheter appropriately.
• The Multi-Array Septal Catheter,
which is designed to create lesions on
the septal wall of the left atrium via six
pairs of electrodes. It is not steerable
and is intended to be used in a
transseptal approach.
• The Multi-Array Ablation Catheter,
which is designed to create ‘‘X’’-like
lesions in the left and/or right atrium
via four pairs of electrodes. It has a
deflectable distal segment and
VerDate Mar<15>2010
15:46 Sep 16, 2011
Jkt 223001
bidirectional steering within a single
plane.
• The GENius Multi-Channel RF
Ablation Generator.
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 October 19, 2011.
Oral presentations from the public will
be scheduled between approximately 1
p.m. and 2 p.m. on October 26 and 27.
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 October 11, 2011. 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
October 13, 2011.
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/
PO 00000
Frm 00074
Fmt 4703
Sfmt 4703
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 13, 2011.
Jill Hartzler Warner,
Acting Associate Commissioner for Special
Medical Programs.
[FR Doc. 2011–23875 Filed 9–16–11; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2008–N–0352]
Prescription Drug User Fee Act IV
Information Technology Plan
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing the
availability of an updated information
technology (IT) plan entitled ‘‘PDUFA
IV Information Technology Plan’’
(updated plan) to achieve the objectives
defined in the Prescription Drug User
Fee Act (PDUFA) Performance Goals.
This plan is intended to provide
regulated industry and other
stakeholders with information on FDA’s
vision and plan for improving the
automation of business processes and
maintaining information systems that
support the process for the review of
human drug applications. The FDA is
publishing the updated plan for
comment to allow the public to provide
feedback as the Agency moves towards
a fully electronic standards-based
submission and review environment.
DATES: Submit electronic or written
comments on the updated plan by
November 3, 2011.
ADDRESSES: You may submit comments,
identified by Docket No. FDA–2008–N–
0352, by any of the following methods:
SUMMARY:
Electronic Submissions
Submit electronic comments in the
following way:
• Federal eRulemaking Portal: https://
www.regulations.gov. Follow the
instructions for submitting comments.
Written Submissions
Submit written submissions in the
following ways:
• Fax: 301–827–6870.
• Mail/Hand delivery/Courier (for
paper, disk, or CD–ROM submissions):
E:\FR\FM\19SEN1.SGM
19SEN1
]]>Agencies
[Federal Register Volume 76, Number 181 (Monday, September 19, 2011)]
[Notices]
[Pages 58019-58020]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-23875]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2011-N-0002]
Circulatory System 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: Circulatory System 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 October 26 and 27, 2011,
from 8 a.m. to 6 p.m.
Location: Hilton Washington, DC, North/Gaithersburg, salons A, B,
C, and D, 620 Perry Pkwy., Gaithersburg, MD.
Contact Person: James Swink, Center for Devices and Radiological
Health, Food and Drug Administration, 10903 New Hampshire Ave., Silver
Spring, MD 20993, e-mail: james.swink@fda.hhs.gov, or FDA Advisory
Committee Information Line, 1-800-741-8138 (301-443-0572 in the
Washington, DC area), and follow the prompts to the desired center or
product area. Please call the Information Line for
[[Page 58020]]
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 October 26, 2011, the committee will discuss, make
recommendations, and vote on information related to the premarket
approval application sponsored by AtriCure, Inc., for the AtriCure
Synergy Ablation System to be used for the treatment of atrial
fibrillation in patients who are undergoing open concomitant cardiac
surgery. The AtriCure Synergy Ablation System consists of the
following:
The AtriCure Isolator Synergy Handpieces (models OLL2 and
OSL2), which resemble surgical clamps, include a syringe-type grip
handle/actuator, connected by a cylindrical shaft to a pair of grasping
jaws with electrodes on each jaw. The electrodes deliver radiofrequency
(RF) energy to the tissue grasped by the jaws.
The Ablation and Sensing Unit is an RF generator used to
power the Isolator Synergy Handpieces.
The Isolator Switch Matrix is an accessory interface
module allowing the Isolator Synergy Handpieces to connect to the RF
generator.
On October 27, 2011, the committee will discuss, make
recommendations, and vote on information related to the premarket
approval application for the Medtronic Ablation Frontiers Cardiac
Ablation System sponsored by Medtronic, Inc. The Medtronic Ablation
Frontiers Cardiac Ablation System is a catheter-based device developed
for the treatment of atrial fibrillation. The system consists of the
following:
The Pulmonary Vein Ablation Catheter, which is designed to
create lesions in the left atrium via five pairs of electrodes to
isolate the pulmonary veins. It has a deflectable distal end and
bidirectional steering to aid in positioning the catheter
appropriately.
The Multi-Array Septal Catheter, which is designed to
create lesions on the septal wall of the left atrium via six pairs of
electrodes. It is not steerable and is intended to be used in a
transseptal approach.
The Multi-Array Ablation Catheter, which is designed to
create ``X''-like lesions in the left and/or right atrium via four
pairs of electrodes. It has a deflectable distal segment and
bidirectional steering within a single plane.
The GENius Multi-Channel RF Ablation Generator.
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
October 19, 2011. Oral presentations from the public will be scheduled
between approximately 1 p.m. and 2 p.m. on October 26 and 27. 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
October 11, 2011. 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 October 13,
2011.
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 13, 2011.
Jill Hartzler Warner,
Acting Associate Commissioner for Special Medical Programs.
[FR Doc. 2011-23875 Filed 9-16-11; 8:45 am]
BILLING CODE 4160-01-P
