Interagency Task Force on Antimicrobial Resistance (ITFAR): An Update on A Public Health Action Plan to Combat Antimicrobial Resistance, 63927-63928 [2011-26562]
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Federal Register / Vol. 76, No. 199 / Friday, October 14, 2011 / Notices
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
Interagency Task Force on
Antimicrobial Resistance (ITFAR): An
Update on A Public Health Action Plan
to Combat Antimicrobial Resistance
Centers for Disease Control and
Prevention (CDC), Department of Health
and Human Services (HHS).
ACTION: Notice of public meeting and
request for comments.
AGENCY:
The Centers for Disease
Control and Prevention (CDC), Food and
Drug Administration (FDA), and
National Institutes of Health (NIH)
announce an open meeting concerning
antimicrobial resistance. The purpose of
the meeting is to present the annual
report on progress by Federal agencies
in accomplishing activities outlined in
A Public Health Action Plan to Combat
Antimicrobial Resistance (Action Plan)
and solicit comments from the public
regarding ITFAR activities including the
Annual Progress Report and the Action
Plan. The meeting will take place at the
Hubert H. Humphrey Building in
Washington, DC on Tuesday, November
15, 2011 from 1 p.m.–3:30 p.m. The
agenda will consist of welcome and
introductory comments, a review of the
Action Plan status and plans to update
it; and reports of the progress toward
implementing the Action Plan in each of
the four focus areas: Surveillance,
Prevention and Control, Research, and
Product Development. The agenda is
subject to change without notice. The
meeting will then be open for comments
from the general public. Persons
wishing to participate, including those
who wish to make an oral presentation,
must register in advance and provide a
copy of their presentation by noon
Tuesday, November 8, 2011.
DATES: A public meeting will be held in
Washington, DC, on Tuesday, November
15, 2011. The meeting will begin at 1
p.m. and end no later than 3:30 p.m.
Deadline for Registration for all
Attendees: All attendees must register
by noon, Tuesday, November 8, 2011.
Deadline for Requests for Special
Accommodation: Requests for special
accommodation should be submitted by
noon, Tuesday, November 8, 2011.
ADDRESSES: Department of Health and
Human Services, Hubert H. Humphrey
Building, Room 800, 200 Independence
Avenue, SW., Washington, DC USA
20201; https://www.hhs.gov/about/
hhhmap.html. Toll Free: 1–877–696–
6775.
tkelley on DSK3SPTVN1PROD with NOTICES
SUMMARY:
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Jkt 226001
Participants should be aware that the
meeting is being held in a Federal
government building; therefore, Federal
security measures are applicable.
FOR FURTHER INFORMATION CONTACT:
Marsha A. Jones, Office of Antimicrobial
Resistance, Centers for Disease Control
and Prevention, 1600 Clifton Road, NE.,
Mailstop A–28, Atlanta, GA 30333;
telephone 404–639–4111; E-mail
MJones@cdc.gov.
Submission of Written Comments:
Written comments and supporting
documentation can be e-mailed to
ARplancomments@cdc.gov or sent via
regular mail to Marsha Jones, Office of
Antimicrobial Resistance, Centers for
Disease Control and Prevention, 1600
Clifton Road, NE., Mailstop A–28,
Atlanta, GA 30333.
Registration and Special
Accommodations: Individuals wishing
to participate or who need special
accommodations or both must register at
ARplancomments@cdc.gov or by
contacting Marsha Jones at
MJones@cdc.gov. See REGISTRATION TO
ATTEND AND/OR PARTICIPATE IN THE PUBLIC
HEARING for instructions on how to
submit electronic notices of
participation.
SUPPLEMENTARY INFORMATION:
1. Background
The Interagency Task Force on
Antimicrobial Resistance (ITFAR) was
created in 1999 to coordinate the
activities of federal agencies in
addressing antimicrobial resistance (AR)
in recognition of the increasing
importance of AR as a public health
threat. The Task Force is co-chaired by
the Centers for Disease Control and
Prevention (CDC), the Food and Drug
Administration (FDA), and the National
Institutes of Health (NIH). Other Task
Force members include the Agency for
Healthcare Research and Quality
(AHRQ), the Centers for Medicare and
Medicaid Services (CMS), the Health
Resources and Services Administration
(HRSA), and the HHS Office of the
Assistant Secretary for Preparedness
and Response (HHS/ASPR), the
Department of Agriculture (USDA), the
Department of Defense (DoD), the
Department of Veterans Affairs (VA),
and the Environmental Protection
Agency (EPA).
In 2001, the ITFAR developed an
initial Action Plan to combat
antimicrobial resistance. In 2011, a
revised version of the Action Plan
which addresses the evolving threat of
antimicrobial resistance was published.
This Plan is entitled A Public Health
Action Plan to Combat Antimicrobial
Resistance and it outlines specific goals,
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63927
actions, and implementation steps
important for addressing the problem of
antimicrobial resistance. Action items
are organized into four focus areas:
Surveillance, Prevention and Control,
Research, and Product Development.
The Action Plan and Annual Report are
available at https://www.cdc.gov/
drugresistance.
2. Public Comment and Meeting
The public meeting process provides
an opportunity for the public to become
aware of and comment on the activities
of the ITFAR to date. In addition, the
ITFAR invites written comments and/or
oral presentations of interested persons
on the Annual Report as well as the four
focus areas of the Action Plan:
Surveillance, Prevention and Control,
Research, and Product Development.
Written comments regarding ITFAR
activities including the Annual Progress
Report and the Action Plan submitted
by e-mail should use the following
subject line ‘‘ITFAR Comments.’’
Written comments submitted by regular
mail should clearly identify ‘‘ITFAR
Comments’’ as the subject.
Comments and suggestions from the
public for Federal agencies related to
the Annual Report and/or any of the
focus areas of the Action Plan will be
taken under advisement by the
Antimicrobial Resistance Interagency
Task Force. The agenda does not
include development of consensus
positions, guidelines, or discussions or
endorsement of specific commercial
products.
3. Registration to Attend and/or
Participate in the Public Meeting
To ensure there is sufficient room we
ask that you pre-register. Seating
capacity is limited to 200 persons. If you
wish to make an oral presentation
during the open public comment period
of the hearing, state your intention to
present on your registration submission.
To register, please send an electronic
mail message to
ARplancomments@cdc.gov by the
deadline listed under DATES. Your email
should include your name and email
address. Please submit a written
statement at the time of registration,
identifying each focus area you wish to
address and the approximate time
requested to make your presentation.
Organizations should provide this
information as well as the names and email addresses of all participants.
Registered individuals will be notified
of the approximate time scheduled for
their presentation prior to the meeting.
The time allotted for presentations will
be limited to 5 minutes. If the number
of proposed presentations exceeds the
E:\FR\FM\14OCN1.SGM
14OCN1
63928
Federal Register / Vol. 76, No. 199 / Friday, October 14, 2011 / Notices
time allotted for public comment,
opportunity for oral presentations
would be limited to the first registered
requestors. All other comments may be
submitted in writing.
4. Building and Security Guidelines
The Hubert H. Humphrey Building is
the headquarters of the U.S. Department
of Health and Human Services located
at the foot of Capitol Hill at 200
Independence Avenue, SW.,
Washington, DC 20201. HHS
headquarters is served by Metrorail and
Metrobus. The closest Metrorail station
is the Federal Center SW., station,
which is served by the Blue and Orange
lines.
The meeting is being held in a Federal
government building; therefore, Federal
security measures are applicable. In
planning your arrival time, please take
account of the need to clear security. All
visitors must enter through the HHS
Hubert H. Humphrey Building main
entrance and must present governmentissued photo identification (e.g., a valid
federal identification badge, state
driver’s license, state non-driver’s
license, or passport). All persons
entering the building must pass through
a metal detector. Visitors are issued a
visitor’s ID wrist band in the main lobby
and are escorted in groups of five to the
meeting room. All items brought to HHS
are subject to inspection.
Dated: October 7, 2011.
James W. Stephens,
Director, Office of Science Quality, Office of
the Associate Director for Science, Centers
for Disease Control and Prevention.
[FR Doc. 2011–26562 Filed 10–13–11; 8:45 am]
BILLING CODE 4163–18–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.
tkelley on DSK3SPTVN1PROD 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: Circulatory
System Devices Panel of the Medical
Devices Advisory Committee.
General Function of the Committee:
To provide advice and
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15:20 Oct 13, 2011
Jkt 226001
recommendations to the Agency on
FDA’s regulatory issues.
Date and Time: The meeting will be
held on December 7 and 8, 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
20877. The hotel’s telephone number is
301–977–8900.
Contact Person: James Swink, Center
for Devices and Radiological Health,
Food and Drug Administration, 10903
New Hampshire Ave., Silver Spring, MD
20993–0002, 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 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 7, 2011, the
committee will discuss, make
recommendations, and vote on
information related to a supplement to
the premarket approval application
(PMA) P010031, sponsored by
Medtronic, Inc. Medtronic is requesting
FDA approval to expand the indications
for use for all commercially available
Medtronic Cardiac Resynchronization
Therapy Defibrillator (CRT–D) devices
covered under PMA P010031. The
company has proposed the following
expanded indication statement based on
the results of the REVERSE and RAFT
clinical studies: ‘‘Medtronic cardiac
resynchronization therapy defibrillator
(CRT–D) systems are indicated for heart
failure patients who meet the following
classification: NYHA Functional Class II
who remain symptomatic despite stable,
optimal medical therapy, and who have
left bundle branch block (LBBB) with a
QRS duration ≥120 ms, and left
ventricular ejection fraction ≤30%.’’
On December 8, 2011, the committee
will discuss, make recommendations,
and vote on information related to the
PMA for the CardioMEMS HF Pressure
Measurement System (HF System)
sponsored by CardioMEMS, Inc. The
CardioMEMS HF System is a
permanently implantable pressure
measurement system designed to
provide daily pulmonary arterial
pressure measurements including
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Fmt 4703
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systolic, diastolic, and mean pulmonary
artery pressure. These measurements are
used to guide treatment of congestive
heart failure. The system consists of the
following:
• Implantable Sensor—The Pressure
Sensor is 15 millimeters (mm) in length,
3.41 mm in width and is 2 mm thick,
consisting 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 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
have a usable length of 120 centimeters
and are compatible with a 0.018’’
guidewire. The Delivery System (with
HF Sensor) is introduced over a
guidewire through an 11Fr 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 user-friendly system
interface for both patients and
clinicians, and transfers PA
measurements to a secure 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 link.
E:\FR\FM\14OCN1.SGM
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]]>Agencies
[Federal Register Volume 76, Number 199 (Friday, October 14, 2011)]
[Notices]
[Pages 63927-63928]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-26562]
[[Page 63927]]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
Interagency Task Force on Antimicrobial Resistance (ITFAR): An
Update on A Public Health Action Plan to Combat Antimicrobial
Resistance
AGENCY: Centers for Disease Control and Prevention (CDC), Department of
Health and Human Services (HHS).
ACTION: Notice of public meeting and request for comments.
-----------------------------------------------------------------------
SUMMARY: The Centers for Disease Control and Prevention (CDC), Food and
Drug Administration (FDA), and National Institutes of Health (NIH)
announce an open meeting concerning antimicrobial resistance. The
purpose of the meeting is to present the annual report on progress by
Federal agencies in accomplishing activities outlined in A Public
Health Action Plan to Combat Antimicrobial Resistance (Action Plan) and
solicit comments from the public regarding ITFAR activities including
the Annual Progress Report and the Action Plan. The meeting will take
place at the Hubert H. Humphrey Building in Washington, DC on Tuesday,
November 15, 2011 from 1 p.m.-3:30 p.m. The agenda will consist of
welcome and introductory comments, a review of the Action Plan status
and plans to update it; and reports of the progress toward implementing
the Action Plan in each of the four focus areas: Surveillance,
Prevention and Control, Research, and Product Development. The agenda
is subject to change without notice. The meeting will then be open for
comments from the general public. Persons wishing to participate,
including those who wish to make an oral presentation, must register in
advance and provide a copy of their presentation by noon Tuesday,
November 8, 2011.
DATES: A public meeting will be held in Washington, DC, on Tuesday,
November 15, 2011. The meeting will begin at 1 p.m. and end no later
than 3:30 p.m.
Deadline for Registration for all Attendees: All attendees must
register by noon, Tuesday, November 8, 2011.
Deadline for Requests for Special Accommodation: Requests for
special accommodation should be submitted by noon, Tuesday, November 8,
2011.
ADDRESSES: Department of Health and Human Services, Hubert H. Humphrey
Building, Room 800, 200 Independence Avenue, SW., Washington, DC USA
20201; https://www.hhs.gov/about/hhhmap.html. Toll Free: 1-877-696-6775.
Participants should be aware that the meeting is being held in a
Federal government building; therefore, Federal security measures are
applicable.
FOR FURTHER INFORMATION CONTACT: Marsha A. Jones, Office of
Antimicrobial Resistance, Centers for Disease Control and Prevention,
1600 Clifton Road, NE., Mailstop A-28, Atlanta, GA 30333; telephone
404-639-4111; E-mail MJones@cdc.gov.
Submission of Written Comments: Written comments and supporting
documentation can be e-mailed to ARplancomments@cdc.gov or sent via
regular mail to Marsha Jones, Office of Antimicrobial Resistance,
Centers for Disease Control and Prevention, 1600 Clifton Road, NE.,
Mailstop A-28, Atlanta, GA 30333.
Registration and Special Accommodations: Individuals wishing to
participate or who need special accommodations or both must register at
ARplancomments@cdc.gov or by contacting Marsha Jones at MJones@cdc.gov.
See Registration to Attend and/or Participate in the Public Hearing for
instructions on how to submit electronic notices of participation.
SUPPLEMENTARY INFORMATION:
1. Background
The Interagency Task Force on Antimicrobial Resistance (ITFAR) was
created in 1999 to coordinate the activities of federal agencies in
addressing antimicrobial resistance (AR) in recognition of the
increasing importance of AR as a public health threat. The Task Force
is co-chaired by the Centers for Disease Control and Prevention (CDC),
the Food and Drug Administration (FDA), and the National Institutes of
Health (NIH). Other Task Force members include the Agency for
Healthcare Research and Quality (AHRQ), the Centers for Medicare and
Medicaid Services (CMS), the Health Resources and Services
Administration (HRSA), and the HHS Office of the Assistant Secretary
for Preparedness and Response (HHS/ASPR), the Department of Agriculture
(USDA), the Department of Defense (DoD), the Department of Veterans
Affairs (VA), and the Environmental Protection Agency (EPA).
In 2001, the ITFAR developed an initial Action Plan to combat
antimicrobial resistance. In 2011, a revised version of the Action Plan
which addresses the evolving threat of antimicrobial resistance was
published. This Plan is entitled A Public Health Action Plan to Combat
Antimicrobial Resistance and it outlines specific goals, actions, and
implementation steps important for addressing the problem of
antimicrobial resistance. Action items are organized into four focus
areas: Surveillance, Prevention and Control, Research, and Product
Development. The Action Plan and Annual Report are available at https://www.cdc.gov/drugresistance.
2. Public Comment and Meeting
The public meeting process provides an opportunity for the public
to become aware of and comment on the activities of the ITFAR to date.
In addition, the ITFAR invites written comments and/or oral
presentations of interested persons on the Annual Report as well as the
four focus areas of the Action Plan: Surveillance, Prevention and
Control, Research, and Product Development.
Written comments regarding ITFAR activities including the Annual
Progress Report and the Action Plan submitted by e-mail should use the
following subject line ``ITFAR Comments.'' Written comments submitted
by regular mail should clearly identify ``ITFAR Comments'' as the
subject.
Comments and suggestions from the public for Federal agencies
related to the Annual Report and/or any of the focus areas of the
Action Plan will be taken under advisement by the Antimicrobial
Resistance Interagency Task Force. The agenda does not include
development of consensus positions, guidelines, or discussions or
endorsement of specific commercial products.
3. Registration to Attend and/or Participate in the Public Meeting
To ensure there is sufficient room we ask that you pre-register.
Seating capacity is limited to 200 persons. If you wish to make an oral
presentation during the open public comment period of the hearing,
state your intention to present on your registration submission. To
register, please send an electronic mail message to
ARplancomments@cdc.gov by the deadline listed under DATES. Your email
should include your name and email address. Please submit a written
statement at the time of registration, identifying each focus area you
wish to address and the approximate time requested to make your
presentation. Organizations should provide this information as well as
the names and e-mail addresses of all participants. Registered
individuals will be notified of the approximate time scheduled for
their presentation prior to the meeting. The time allotted for
presentations will be limited to 5 minutes. If the number of proposed
presentations exceeds the
[[Page 63928]]
time allotted for public comment, opportunity for oral presentations
would be limited to the first registered requestors. All other comments
may be submitted in writing.
4. Building and Security Guidelines
The Hubert H. Humphrey Building is the headquarters of the U.S.
Department of Health and Human Services located at the foot of Capitol
Hill at 200 Independence Avenue, SW., Washington, DC 20201. HHS
headquarters is served by Metrorail and Metrobus. The closest Metrorail
station is the Federal Center SW., station, which is served by the Blue
and Orange lines.
The meeting is being held in a Federal government building;
therefore, Federal security measures are applicable. In planning your
arrival time, please take account of the need to clear security. All
visitors must enter through the HHS Hubert H. Humphrey Building main
entrance and must present government-issued photo identification (e.g.,
a valid federal identification badge, state driver's license, state
non-driver's license, or passport). All persons entering the building
must pass through a metal detector. Visitors are issued a visitor's ID
wrist band in the main lobby and are escorted in groups of five to the
meeting room. All items brought to HHS are subject to inspection.
Dated: October 7, 2011.
James W. Stephens,
Director, Office of Science Quality, Office of the Associate Director
for Science, Centers for Disease Control and Prevention.
[FR Doc. 2011-26562 Filed 10-13-11; 8:45 am]
BILLING CODE 4163-18-P
