Request for Information Relevant to the Regionalization of Emergency Medical Care Delivery Systems and Demonstration Model Development, 42673-42674 [E9-20162]
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Federal Register / Vol. 74, No. 162 / Monday, August 24, 2009 / Notices
3104. Comments regarding this
proposed action will be accepted until
September 23, 2009.
A. Stanley Meiburg,
Acting Regional Administrator, Region 4.
[FR Doc. E9–20288 Filed 8–21–09; 8:45 am]
BILLING CODE 6560–50–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Request for Information Relevant to
the Regionalization of Emergency
Medical Care Delivery Systems and
Demonstration Model Development
erowe on DSK5CLS3C1PROD with NOTICES
AGENCY: Department of Health and
Human Services, Office of the Secretary.
ACTION: Notice.
SUMMARY: This is a time-sensitive
Request for Information (RFI) issued by
the Emergency Care Coordination
Center in the Office of the Assistant
Secretary for Preparedness and
Response on behalf of the Council on
Emergency Medical Care (CEMC) and
the Federal Interagency Committee on
Emergency Medical Services
(FICEMS)—collectively known as the
Emergency Care Enterprise (ECE). The
information requested is meant to
ascertain key concepts, best practices,
and operational approaches to support
regionalized, comprehensive and
accountable emergency care and trauma
systems. The information will be
analyzed by the ECCC to help guide the
development of demonstration programs
that design and evaluate innovative
models of regionalized, coordinated and
accountable emergency care and trauma
systems.
ADDRESSES: Responses to this RFI may
be submitted electronically to
eccc@hhs.gov by COB September 30th
2009.
FOR FURTHER INFORMATION CONTACT: For
further information on this RFI or the
Emergency Care Coordination Center
(ECCC), please contact Melicia Seay,
Program Analyst, by e-mail at
melicia.seay@hhs.gov or by phone at
202–260–1383.
SUPPLEMENTARY INFORMATION: The
Emergency Care Coordination Center
(ECCC) was created in order to: (1) Lead
an enterprise to promote and fund
research in emergency medicine and
trauma health care, (2) promote regional
partnerships and more effective
emergency medical systems in order to
enhance appropriate triage, distribution,
and care of routine community patients,
and (3) promote local, regional, and
State emergency medical systems’
preparedness for and response to public
VerDate Nov<24>2008
15:04 Aug 21, 2009
Jkt 217001
health events. The office addresses the
full spectrum of issues that have impact
on care in hospital emergency
departments, encompassing the
complete continuum of patient care
from the pre-hospital environment to
disposition from emergency or trauma
care. The Office coordinates with
existing executive departments and
agencies that perform functions relating
to emergency medical systems in order
to ensure unified strategy, policy, and
implementation.
The issue of regionalization is one of
great interest across academic and
clinical communities and is frequently
touted as a potential solution to
healthcare reform. The Future of
Emergency Care reports published by
the Institute of Medicine in 2006
recommended the establishment of a
demonstration program to promote
coordinated, regionalized, and
accountable emergency care delivery
systems. As demonstrated by existing
systems for trauma, cardiac arrest, and
stroke patients, regionalized emergency
care systems help get the right patients
to the right hospitals in the right amount
of time, improve patient outcomes, and
reduce costs. These systems typically
require careful coordination amongst 9–
1–1 dispatch, pre-hospital emergency
medical services, EMS system medical
direction, categorization/designation of
medical facilities, interfacility transfer
protocols, data collection/analysis, and
ongoing system-wide quality
improvement.
Yet regionalization of emergency care
remains poorly defined and often
misunderstood, with competing
definitions, a variety of organizational
and financial structures, and a lack of
understanding regarding the
implementation, evaluation, feasibility,
and long term consequences of regional
emergency care. Even amongst the State
Trauma Systems, for instance, there is
wide-scale variability in terms of
resourcing mechanisms, support levels,
functionality, and systems-wide
interoperability. While some states have
data mechanisms in place to monitor
emergency care system status including
medical facility bed availability and
patient tracking, these systems vary in
terms of management, sophistication
and purpose, often collecting and
reporting different data without uniform
data definitions or agreement on which
data should be collected.
The ECCC, in coordination with the
CEMC and FICEMS, aims to
demonstrate model systems for
Emergency Care through the
development of regionalization
demonstration projects that will provide
information and lessons learned while
PO 00000
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Fmt 4703
Sfmt 4703
42673
generating guidance for the nationwide
deployment of regionalized and
accountable emergency care delivery
systems.
Issues on Which Information Is
Requested
The ECCC seeks input regarding
regionalization of emergency care, with
a focus on identification of the
challenges and opportunities that could
be addressed through federally funded
national demonstration projects. The
scope of emergency care being
considered is defined as beginning with
an event, disease, or condition that
causes an individual to seek care
through EMS or in an ED setting and
ending with departure from the ED
(either by admission to another hospital
department, through discharge from the
ED, or via transfer to another hospital).
We welcome your comments, research
findings, and/or practical experience on
the following topics that can be used
both to enhance our knowledge of
regional emergency care networks and
to help formulate guidance and
strategies for potential Federal programs
to develop regional emergency care
systems. Please provide concise
responses in the context of
regionalization to any or all of the
following topics.
A. Existing Models. Please describe
existing trauma or EMS regions in terms
of characteristics such as: overall
structure and organization, boundaries
and geography, governance or oversight
mechanisms and authorities, triagetransfer protocols, sustained financial
support and provider reimbursement,
data collection procedures, resource
tracking, and communication/
coordination of relationships amongst
State leadership, 9–1–1 services and/or
EMS system medical direction,
individual regions, etc. If desired,
include opinions regarding the overall
functioning and effectiveness of existing
systems.
B. Analysis of Current Practices in
Regionalized Clinical Care. Whether at
the local, State, or inter-State level,
please provide suggestions and
justifications as to which existing
systems or specific elements of
regionalized care models specifically
merit further investigation,
development, or targeted alteration and
which clinical conditions are most
suitable to regionalized care delivery.
Please provide specific evidence where
available and applicable.
C. Communications Infrastructure.
Please provide information on
appropriate data elements that should
be incorporated within regionalization
systems to provide for situational
E:\FR\FM\24AUN1.SGM
24AUN1
erowe on DSK5CLS3C1PROD with NOTICES
42674
Federal Register / Vol. 74, No. 162 / Monday, August 24, 2009 / Notices
awareness on resource availability. List
the measurable variables and data
elements that you believe need to be
defined and captured in order to
effectively support regional delivery of
care. Also include any suggestions as to
which common data elements, at a
minimum, should be included within a
standardized data language to facilitate,
encourage, and improve the support and
integration of the various state resource
tracking mechanisms.
D. Opportunities and challenges in
regionalized care delivery. Please share
your opinions on the potential benefits,
obstacles, drawbacks, and consequences
(both intended and unintended) of
regionalized healthcare models,
providing specific evidence where
feasible. If possible, elaborate on the
effects regionalization may produce on
providers’ financial viability, patient
access to care, healthcare service
utilization rates, disaster preparedness
efforts, and response capabilities.
E. Evaluation of regionalized care
delivery systems. Please provide
comments on how regionalized care
systems can be objectively assessed and
evaluated, including suggestions on
appropriate measures of programmatic
success or failure and opinions on
which data sources could be used to
establish compliance with regional
performance benchmarks. Where
possible, also list measurable ways to
assess regionalization’s impact with
regard to health outcomes, including
factors such as morbidity and mortality,
time-to-care, condition-specific
treatment, quality of care, patient safety,
etc.
F. Adaptation of regionalization to
emergency medical care. Given the legal
requirement to screen and stabilize ED
patients, the need for time-sensitive,
high-quality care in emergency settings,
and the diversity of patient populations
and geographic locations, please
provide insights or commentary on how
the concept of regionalization could be
adapted and/or customized to fit the
unique aspects of emergency medical
care.
G. Additional information. Please
provide any additional opinions,
suggestions, or comments as to how the
ECCC and the Emergency Care
Enterprise can shape demonstration
projects of regionalized, coordinated,
and accountable systems of emergency
care to effectively utilize limited
resources, facilitate information
management and flow, increase the
efficiency and effectiveness of the
emergency healthcare delivery system,
and enhance the overall quality of care
provided.
VerDate Nov<24>2008
15:04 Aug 21, 2009
Jkt 217001
Please indicate which type of
institution or organization you are
primarily affiliated with (using the
following categories):
• Academia;
• Small Business;
• Healthcare Facility;
• Trauma or EMSS region;
• Federal Government;
• State Government;
• Healthcare Professional;
• Patient Advocacy Group;
• Other (briefly define).
This request for information is for
planning purposes only and shall not be
interpreted as a solicitation for
applications or as an obligation on the
part of the government. The government
will not pay for the preparation of any
information submitted or for the
government’s use of that information.
Dated: August 14, 2009.
Nicole Lurie,
Assistant Secretary for Preparedness and
Response, Rear Admiral, U.S. Public Health
Service.
[FR Doc. E9–20162 Filed 8–21–09; 8:45 am]
BILLING CODE 4150–37–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2009–N–0360]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; FDA Public Health
Notification Readership Survey
(formerly known as ‘‘Safety Alert/
Public Health Advisory Readership
Survey’’)
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) is announcing an
opportunity for public comment on the
proposed collection of certain
information by the agency. Under the
Paperwork Reduction Act of 1995 (the
PRA), Federal agencies are required to
publish notice in the Federal Register
concerning each proposed collection of
information, including each proposed
extension of an existing collection of
information, and to allow 60 days for
public comment in response to the
notice. This notice solicits comments on
FDA Public Health Notification
Readership Survey.
DATES: Submit written or electronic
comments on the collection of
information by October 23, 2009.
ADDRESSES: Submit electronic
comments on the collection of
PO 00000
Frm 00031
Fmt 4703
Sfmt 4703
information to https://
www.regulations.gov. Submit written
comments on the collection of
information to the Division of Dockets
Management (HFA–305), Food and Drug
Administration, 5630 Fishers Lane, rm.
1061, Rockville, MD 20852. All
comments should be identified with the
docket number found in brackets in the
heading of this document.
FOR FURTHER INFORMATION CONTACT:
Denver Presley, Jr., Office of Information
Management (HFA–710), Food and Drug
Administration, 5600 Fishers Lane,
Rockville, MD 20857, 301–796–3793.
SUPPLEMENTARY INFORMATION: Under the
PRA (44 U.S.C. 3501–3520), Federal
agencies must obtain approval from the
Office of Management and Budget
(OMB) for each collection of
information they conduct or sponsor.
‘‘Collection of information’’ is defined
in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes agency requests
or requirements that members of the
public submit reports, keep records, or
provide information to a third party.
Section 3506(c)(2)(A) of the PRA (44
U.S.C. 3506(c)(2)(A)) requires Federal
agencies to provide a 60-day notice in
the Federal Register concerning each
proposed collection of information,
including each proposed extension of an
existing collection of information,
before submitting the collection to OMB
for approval. To comply with this
requirement, FDA is publishing notice
of the proposed collection of
information set forth in this document.
With respect to the following
collection of information, FDA invites
comments on these topics: (1) Whether
the proposed collection of information
is necessary for the proper performance
of FDA’s functions, including whether
the information will have practical
utility; (2) the accuracy of FDA’s
estimate of the burden of the proposed
collection of information, including the
validity of the methodology and
assumptions used; (3) ways to enhance
the quality, utility, and clarity of the
information to be collected; and (4)
ways to minimize the burden of the
collection of information on
respondents, including through the use
of automated collection techniques,
when appropriate, and other forms of
information technology.
FDA Public Health Notification
Readership Survey (formerly known as
Safety Alert/Public Health Advisory
Readership Survey) (PHS Act, Section
1701 (a)(4)); OMB Control Number
0910–0341–Extension
Section 705(b) of the Federal Food,
Drug, and Cosmetic Act (the act) (21
E:\FR\FM\24AUN1.SGM
24AUN1
Agencies
[Federal Register Volume 74, Number 162 (Monday, August 24, 2009)]
[Notices]
[Pages 42673-42674]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-20162]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Request for Information Relevant to the Regionalization of
Emergency Medical Care Delivery Systems and Demonstration Model
Development
AGENCY: Department of Health and Human Services, Office of the
Secretary.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: This is a time-sensitive Request for Information (RFI) issued
by the Emergency Care Coordination Center in the Office of the
Assistant Secretary for Preparedness and Response on behalf of the
Council on Emergency Medical Care (CEMC) and the Federal Interagency
Committee on Emergency Medical Services (FICEMS)--collectively known as
the Emergency Care Enterprise (ECE). The information requested is meant
to ascertain key concepts, best practices, and operational approaches
to support regionalized, comprehensive and accountable emergency care
and trauma systems. The information will be analyzed by the ECCC to
help guide the development of demonstration programs that design and
evaluate innovative models of regionalized, coordinated and accountable
emergency care and trauma systems.
ADDRESSES: Responses to this RFI may be submitted electronically to
eccc@hhs.gov by COB September 30th 2009.
FOR FURTHER INFORMATION CONTACT: For further information on this RFI or
the Emergency Care Coordination Center (ECCC), please contact Melicia
Seay, Program Analyst, by e-mail at melicia.seay@hhs.gov or by phone at
202-260-1383.
SUPPLEMENTARY INFORMATION: The Emergency Care Coordination Center
(ECCC) was created in order to: (1) Lead an enterprise to promote and
fund research in emergency medicine and trauma health care, (2) promote
regional partnerships and more effective emergency medical systems in
order to enhance appropriate triage, distribution, and care of routine
community patients, and (3) promote local, regional, and State
emergency medical systems' preparedness for and response to public
health events. The office addresses the full spectrum of issues that
have impact on care in hospital emergency departments, encompassing the
complete continuum of patient care from the pre-hospital environment to
disposition from emergency or trauma care. The Office coordinates with
existing executive departments and agencies that perform functions
relating to emergency medical systems in order to ensure unified
strategy, policy, and implementation.
The issue of regionalization is one of great interest across
academic and clinical communities and is frequently touted as a
potential solution to healthcare reform. The Future of Emergency Care
reports published by the Institute of Medicine in 2006 recommended the
establishment of a demonstration program to promote coordinated,
regionalized, and accountable emergency care delivery systems. As
demonstrated by existing systems for trauma, cardiac arrest, and stroke
patients, regionalized emergency care systems help get the right
patients to the right hospitals in the right amount of time, improve
patient outcomes, and reduce costs. These systems typically require
careful coordination amongst 9-1-1 dispatch, pre-hospital emergency
medical services, EMS system medical direction, categorization/
designation of medical facilities, interfacility transfer protocols,
data collection/analysis, and ongoing system-wide quality improvement.
Yet regionalization of emergency care remains poorly defined and
often misunderstood, with competing definitions, a variety of
organizational and financial structures, and a lack of understanding
regarding the implementation, evaluation, feasibility, and long term
consequences of regional emergency care. Even amongst the State Trauma
Systems, for instance, there is wide-scale variability in terms of
resourcing mechanisms, support levels, functionality, and systems-wide
interoperability. While some states have data mechanisms in place to
monitor emergency care system status including medical facility bed
availability and patient tracking, these systems vary in terms of
management, sophistication and purpose, often collecting and reporting
different data without uniform data definitions or agreement on which
data should be collected.
The ECCC, in coordination with the CEMC and FICEMS, aims to
demonstrate model systems for Emergency Care through the development of
regionalization demonstration projects that will provide information
and lessons learned while generating guidance for the nationwide
deployment of regionalized and accountable emergency care delivery
systems.
Issues on Which Information Is Requested
The ECCC seeks input regarding regionalization of emergency care,
with a focus on identification of the challenges and opportunities that
could be addressed through federally funded national demonstration
projects. The scope of emergency care being considered is defined as
beginning with an event, disease, or condition that causes an
individual to seek care through EMS or in an ED setting and ending with
departure from the ED (either by admission to another hospital
department, through discharge from the ED, or via transfer to another
hospital).
We welcome your comments, research findings, and/or practical
experience on the following topics that can be used both to enhance our
knowledge of regional emergency care networks and to help formulate
guidance and strategies for potential Federal programs to develop
regional emergency care systems. Please provide concise responses in
the context of regionalization to any or all of the following topics.
A. Existing Models. Please describe existing trauma or EMS regions
in terms of characteristics such as: overall structure and
organization, boundaries and geography, governance or oversight
mechanisms and authorities, triage-transfer protocols, sustained
financial support and provider reimbursement, data collection
procedures, resource tracking, and communication/coordination of
relationships amongst State leadership, 9-1-1 services and/or EMS
system medical direction, individual regions, etc. If desired, include
opinions regarding the overall functioning and effectiveness of
existing systems.
B. Analysis of Current Practices in Regionalized Clinical Care.
Whether at the local, State, or inter-State level, please provide
suggestions and justifications as to which existing systems or specific
elements of regionalized care models specifically merit further
investigation, development, or targeted alteration and which clinical
conditions are most suitable to regionalized care delivery. Please
provide specific evidence where available and applicable.
C. Communications Infrastructure. Please provide information on
appropriate data elements that should be incorporated within
regionalization systems to provide for situational
[[Page 42674]]
awareness on resource availability. List the measurable variables and
data elements that you believe need to be defined and captured in order
to effectively support regional delivery of care. Also include any
suggestions as to which common data elements, at a minimum, should be
included within a standardized data language to facilitate, encourage,
and improve the support and integration of the various state resource
tracking mechanisms.
D. Opportunities and challenges in regionalized care delivery.
Please share your opinions on the potential benefits, obstacles,
drawbacks, and consequences (both intended and unintended) of
regionalized healthcare models, providing specific evidence where
feasible. If possible, elaborate on the effects regionalization may
produce on providers' financial viability, patient access to care,
healthcare service utilization rates, disaster preparedness efforts,
and response capabilities.
E. Evaluation of regionalized care delivery systems. Please provide
comments on how regionalized care systems can be objectively assessed
and evaluated, including suggestions on appropriate measures of
programmatic success or failure and opinions on which data sources
could be used to establish compliance with regional performance
benchmarks. Where possible, also list measurable ways to assess
regionalization's impact with regard to health outcomes, including
factors such as morbidity and mortality, time-to-care, condition-
specific treatment, quality of care, patient safety, etc.
F. Adaptation of regionalization to emergency medical care. Given
the legal requirement to screen and stabilize ED patients, the need for
time-sensitive, high-quality care in emergency settings, and the
diversity of patient populations and geographic locations, please
provide insights or commentary on how the concept of regionalization
could be adapted and/or customized to fit the unique aspects of
emergency medical care.
G. Additional information. Please provide any additional opinions,
suggestions, or comments as to how the ECCC and the Emergency Care
Enterprise can shape demonstration projects of regionalized,
coordinated, and accountable systems of emergency care to effectively
utilize limited resources, facilitate information management and flow,
increase the efficiency and effectiveness of the emergency healthcare
delivery system, and enhance the overall quality of care provided.
Please indicate which type of institution or organization you are
primarily affiliated with (using the following categories):
Academia;
Small Business;
Healthcare Facility;
Trauma or EMSS region;
Federal Government;
State Government;
Healthcare Professional;
Patient Advocacy Group;
Other (briefly define).
This request for information is for planning purposes only and
shall not be interpreted as a solicitation for applications or as an
obligation on the part of the government. The government will not pay
for the preparation of any information submitted or for the
government's use of that information.
Dated: August 14, 2009.
Nicole Lurie,
Assistant Secretary for Preparedness and Response, Rear Admiral, U.S.
Public Health Service.
[FR Doc. E9-20162 Filed 8-21-09; 8:45 am]
BILLING CODE 4150-37-P