Circulatory System Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting, 55081-55082 [2013-21827]
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Federal Register / Vol. 78, No. 174 / Monday, September 9, 2013 / Notices
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Administration for Children and
Families
[CFDA Number: 93.293]
Announcing the Award of a SingleSource Cooperative Agreement to the
American Public Human Services
Association for the Association of
Administrators of the Interstate
Compact on the Placement of Children
(AAICPC) in Washington, DC
Children’s Bureau,
Administration on Children, Youth and
Families, ACF, HHS.
ACTION: Notice of the award of a singlesource cooperative agreement to the
American Public Human Services
Association to support the development
and implementation of a national interjurisdictional Interstate Compact on the
Placement of Children (ICPC) electronic
system.
AGENCY:
The Administration for
Children and Families (ACF),
Administration on Children, Youth and
Families (ACYF), Children’s Bureau
(CB), Division of Capacity Building
announces the award of a single-source
cooperative agreement in the amount of
$1,250,000 to the American Public
Human Services Association for its
affiliate the Association of
Administrators of the Interstate
Compact on the Placement of Children
(AAICPC), Washington, DC, for the
development and implementation of an
inter-jurisdictional electronic system to
improve administrative efficiency in the
interstate process of the ICPC. The ICPC
ensures safe and suitable interstate
placements for children in foster care.
Award funds will support the
development and implementation of a
national inter-jurisdictional Interstate
Compact on the Placement of Children
(ICPC) electronic system to improve
administrative efficiency in the
interstate process via the ICPC.
This pilot, ‘‘Supporting Permanent
Placement of Foster Care Children
Through Electronic Records Exchange,’’
implements real-time, on-line data
exchange for States to share records and
other information to support permanent
placements of foster care children in
homes across state lines. The
Association of Administrators of the
Interstate Compact on the Placement of
Children (AAICPC) has identified
current paper-based processes as
causing excessive delays. Children may
wait an unnecessarily long time for the
paperwork for placement in a
permanent home to be executed
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SUMMARY:
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manually. The pilot will test whether an
automated system reduces the time to
process such cross-state exchanges to
determine whether a placement is safe
and suitable.
The pilot evaluation will measure
timeliness of communication,
expeditious exchange of case
documentation and similar immediate
outcomes as well as utilization and
adherence to streamlined ICPC
processes. Additional questions, such as
those related to the permanency of child
placements and the associated savings,
may be addressed if it is feasible to do
so within the project period. Results,
which will be included in a final public
report, will inform further adoption of
the system across states.
The initial pilot will include at least
5 states and ultimately, beyond the pilot
period, the system will be used by all 50
states, the District of Columbia and the
U.S. Virgin Islands (ICPC Compact
Members). The system will serve and
benefit children, families, the public,
private and tribal child welfare agencies
nationwide and other multidisciplinary
groups that work in support of the and
throughout the child placement
continuum.
DATES: The 17 month period of support
for this award is September 30, 2013
through February 28, 2015.
FOR FURTHER INFORMATION CONTACT: June
Dorn, National Adoption Specialist,
Division of Capacity Building, 1250
Maryland Avenue SW., Suite 8150,
Washington, DC 20024. Telephone:
202–205–9540; Email:
June.Dorn@acf.hhs.gov.
SUPPLEMENTARY INFORMATION: The
Partnership Fund, administered by the
Office of Management and Budget
(OMB), supports pilot projects that test
improvements in how Federal
assistance programs are administered.
The pilot projects address the four goals
of improving service delivery,
improving payment accuracy,
improving administrative efficiency and
reducing barriers to access for eligible
people. Using $32.5 million
appropriation, the Partnership Fund
allows Federal, state, and local
government agencies to pilot innovative
ideas in a controlled environment. Pilot
projects funded by the Partnership Fund
address Federal assistance programs
that have a substantial State role in
eligibility determination or
administration, or where Federal-State
cooperation could otherwise be
beneficial. Ideas for pilots are developed
through a collaborative process
involving Federal, state, local, and
private stakeholders. The OMB consults
with a Federal Steering Committee to
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55081
select pilots for funding. Funds are then
transferred to lead Federal agencies,
which in turn select states and localities
to implement each pilot. Based on
careful evaluation, successful pilots
serve as models for other states and
agencies and inform future policy
decisions by the Administration and
Congress.
Statutory Authority: The transfer of
funding from the Partnership Fund for
Program Integrity Innovation by the
OMB to Federal agencies is authorized
by the Consolidated Appropriations Act,
2010 (Pub. L. 111–117) and the
Consolidated Appropriations Act, 2012
(Pub. L. 112–74)
Joseph Bock,
Associate Acting Commissioner,
Administration on Children, Youth and
Families.
[FR Doc. 2013–21755 Filed 9–6–13; 8:45 am]
BILLING CODE 4184–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2013–N–0001]
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 8 and 9, 2013, 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
20877. The hotel’s telephone number is
301–977–8900.
Contact Person: Jamie Waterhouse,
Center for Devices and Radiological
Health, Food and Drug Administration,
10903 New Hampshire Ave., Silver
Spring, MD 20993, 301–796–3063, 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
E:\FR\FM\09SEN1.SGM
09SEN1
tkelley on DSK3SPTVN1PROD with NOTICES
55082
Federal Register / Vol. 78, No. 174 / Monday, September 9, 2013 / Notices
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 both days the committee
will discuss, make recommendations,
and vote on devices indicated for use in
patients with heart failure (HF). On
October 8, 2013, the committee will
discuss, make recommendations, and
vote on information related to the
premarket approval application
regarding the expansion of indications
supported by the BLOCK HF trial to
apply to all market-approved Medtronic
Cardiac Resynchronization TherapyPacemaker (CRT–P) and Cardiac
Resynchronization Therapy-Defibrillator
(CRT–D) devices. The devices are pulse
generators either without (CRT–P) or
with (CRT–D) defibrillation capabilities.
The devices require the implantation of
at least a right ventricular (RV) and a left
ventricular (LV) lead for sensing and
pacing functionality. The RV lead used
with a CRT–D device also has the
capability to deliver high voltage
energy. The implantation of a right atrial
(RA) lead is left to the discretion of the
clinician for both devices.
The requested expansion in
indications for use was studied under
the BLOCK HF trial. The trial was a
prospective, multisite, randomized,
double-blinded, parallel-controlled
investigational device exemption (IDE)
study. The primary objective of the trial
was to demonstrate that the time until
the first event of all-cause mortality,
heart-failure-related urgent care, or a
significant increase in left ventricular
end systolic volume index (LVESVI) for
subjects programmed to biventricular
pacing is superior to that of subjects
programmed to right ventricular pacing.
On October 9, 2013, the committee
will discuss, make recommendations,
and vote on information related to the
premarket approval application for
CardioMEMS, Inc. ChampionTM HF
Monitoring System. The CardioMEMS
HF System is a permanently
implantable pressure measurement
system designed to provide daily
pulmonary arterial pressure
measurements including systolic,
diastolic, and mean pulmonary arterial
(PA) pressure. These measurements are
used to guide treatment of congestive
heart failure. The system consists of the
following:
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15:01 Sep 06, 2013
Jkt 229001
Implantable Sensor—The Pressure
Sensor consists of a three-dimensional
coil and pressure-sensitive capacitor
encased between two wafers of fused
silica. The coil (inductor)
electromagnetically couples to the
Sensor and allows the remote
measurement of the resonant frequency
of the inductive/capacitive (LC) circuit.
This allows for wireless communication
with the Sensor and eliminates the need
for an onboard source of energy, such as
a battery.
Delivery System—The Delivery
System allows the placement of the
Pressure Sensor within the distal
pulmonary artery. There are two
versions of the Delivery System. The
first includes a hydrophilic coating on
the distal portion of the catheter shaft
and the second has no coating on the
catheter shaft. Both delivery catheters
are compatible with a guidewire. The
Delivery System (with HF Sensor) is
introduced over a guidewire through a
sheath. Tether wires connect the Sensor
to the Delivery System until the
physician determines that the Sensor is
properly positioned within the distal
pulmonary artery. Once the Sensor is in
position, the tether wires are
withdrawn, releasing the Sensor.
Electronics Unit (Interrogator) and
database—The Electronics Unit contains
hardware and software to acquire and
process signals from the sensor,
provides a system interface for both
patients and clinicians, and transfers PA
measurements to a database for review
by medical professionals. The database
is a Web-based server that contains
software, which receives data
transmitted from the electronics unit,
and presents the data for review by
medical professionals.
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.
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 September 24, 2013.
On October 8 and 9, 2013, oral
presentations from the public will be
PO 00000
Frm 00031
Fmt 4703
Sfmt 9990
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
September 16, 2013. 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 September 18, 2013.
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 AnnMarie.Williams@
fda.hhs.gov or 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 4, 2013.
Jill Hartzler Warner,
Acting Associate Commissioner for Special
Medical Programs.
[FR Doc. 2013–21827 Filed 9–6–13; 8:45 am]
BILLING CODE 4160–01–P
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09SEN1
Agencies
[Federal Register Volume 78, Number 174 (Monday, September 9, 2013)]
[Notices]
[Pages 55081-55082]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-21827]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2013-N-0001]
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 8 and 9, 2013,
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 20877. The hotel's telephone
number is 301-977-8900.
Contact Person: Jamie Waterhouse, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Silver Spring, MD 20993, 301-796-3063, 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
[[Page 55082]]
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 both days the committee will discuss, make
recommendations, and vote on devices indicated for use in patients with
heart failure (HF). On October 8, 2013, the committee will discuss,
make recommendations, and vote on information related to the premarket
approval application regarding the expansion of indications supported
by the BLOCK HF trial to apply to all market-approved Medtronic Cardiac
Resynchronization Therapy-Pacemaker (CRT-P) and Cardiac
Resynchronization Therapy-Defibrillator (CRT-D) devices. The devices
are pulse generators either without (CRT-P) or with (CRT-D)
defibrillation capabilities. The devices require the implantation of at
least a right ventricular (RV) and a left ventricular (LV) lead for
sensing and pacing functionality. The RV lead used with a CRT-D device
also has the capability to deliver high voltage energy. The
implantation of a right atrial (RA) lead is left to the discretion of
the clinician for both devices.
The requested expansion in indications for use was studied under
the BLOCK HF trial. The trial was a prospective, multisite, randomized,
double-blinded, parallel-controlled investigational device exemption
(IDE) study. The primary objective of the trial was to demonstrate that
the time until the first event of all-cause mortality, heart-failure-
related urgent care, or a significant increase in left ventricular end
systolic volume index (LVESVI) for subjects programmed to biventricular
pacing is superior to that of subjects programmed to right ventricular
pacing.
On October 9, 2013, the committee will discuss, make
recommendations, and vote on information related to the premarket
approval application for CardioMEMS, Inc. ChampionTM HF
Monitoring System. The CardioMEMS HF System is a permanently
implantable pressure measurement system designed to provide daily
pulmonary arterial pressure measurements including systolic, diastolic,
and mean pulmonary arterial (PA) pressure. These measurements are used
to guide treatment of congestive heart failure. The system consists of
the following:
Implantable Sensor--The Pressure Sensor consists of a three-
dimensional coil and pressure-sensitive capacitor encased between two
wafers of fused silica. The coil (inductor) electromagnetically couples
to the Sensor and allows the remote measurement of the resonant
frequency of the inductive/capacitive (LC) circuit. This allows for
wireless communication with the Sensor and eliminates the need for an
onboard source of energy, such as a battery.
Delivery System--The Delivery System allows the placement of the
Pressure Sensor within the distal pulmonary artery. There are two
versions of the Delivery System. The first includes a hydrophilic
coating on the distal portion of the catheter shaft and the second has
no coating on the catheter shaft. Both delivery catheters are
compatible with a guidewire. The Delivery System (with HF Sensor) is
introduced over a guidewire through a sheath. Tether wires connect the
Sensor to the Delivery System until the physician determines that the
Sensor is properly positioned within the distal pulmonary artery. Once
the Sensor is in position, the tether wires are withdrawn, releasing
the Sensor.
Electronics Unit (Interrogator) and database--The Electronics Unit
contains hardware and software to acquire and process signals from the
sensor, provides a system interface for both patients and clinicians,
and transfers PA measurements to a database for review by medical
professionals. The database is a Web-based server that contains
software, which receives data transmitted from the electronics unit,
and presents the data for review by medical professionals.
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.
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
September 24, 2013. On October 8 and 9, 2013, 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
September 16, 2013. 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 September 18,
2013.
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 AnnMarie.Williams@fda.hhs.gov or 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 4, 2013.
Jill Hartzler Warner,
Acting Associate Commissioner for Special Medical Programs.
[FR Doc. 2013-21827 Filed 9-6-13; 8:45 am]
BILLING CODE 4160-01-P