[Federal Register Volume 80, Number 138 (Monday, July 20, 2015)]
[Notices]
[Pages 42820-42822]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-17699]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[60Day-15-15AUJ; Docket No. CDC-2015-0056]
Proposed Data Collection Submitted for Public Comment and
Recommendations
AGENCY: Centers for Disease Control and Prevention (CDC), Department of
Health and Human Services (HHS).
ACTION: Notice with comment period.
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SUMMARY: The Centers for Disease Control and Prevention (CDC), as part
of its continuing efforts to reduce public burden and maximize the
utility of government information, invites the general public and other
Federal agencies to take this opportunity to comment on proposed and/or
continuing information collections, as required by the Paperwork
Reduction Act of 1995. This notice invites comment on the Paul
Coverdell National Acute Stroke Program (PCNASP) reporting system,
which was established to improve quality of care for acute stroke
patients from onset of signs and symptoms through hospital care and
rehabilitation and recovery.
DATES: Written comments must be received on or before September 18,
2015.
ADDRESSES: You may submit comments, identified by Docket No. CDC-2015-
0056 by any of the following methods:
Federal eRulemaking Portal: Regulation.gov. Follow the instructions
for submitting comments.
Mail: Leroy A. Richardson, Information Collection Review Office,
Centers for Disease Control and Prevention, 1600 Clifton Road NE., MS-
D74, Atlanta, Georgia 30329.
Instructions: All submissions received must include the agency name
and Docket Number. All relevant comments received will be posted
without change to Regulations.gov, including any personal information
provided. For access to the docket to read background documents or
comments received, go to Regulations.gov.
Please note: All public comment should be submitted through the
Federal eRulemaking portal (Regulations.gov) or by U.S. mail to the
address listed above.
FOR FURTHER INFORMATION CONTACT: To request more information on the
proposed project or to obtain a copy of the information collection plan
and instruments, contact the Information Collection Review Office,
Centers for Disease Control and Prevention, 1600 Clifton Road NE., MS-
D74, Atlanta, Georgia 30329; phone: 404-639-7570; Email: [email protected].
SUPPLEMENTARY INFORMATION: Under the Paperwork Reduction Act of 1995
(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. In addition, the PRA also requires
Federal agencies to provide a 60-day notice in the Federal Register
concerning each proposed collection of information, including each new
[[Page 42821]]
proposed collection, each proposed extension of existing collection of
information, and each reinstatement of previously approved information
collection before submitting the collection to OMB for approval. To
comply with this requirement, we are publishing this notice of a
proposed data collection as described below.
Comments are invited on: (a) Whether the proposed collection of
information is necessary for the proper performance of the functions of
the agency, including whether the information shall have practical
utility; (b) the accuracy of the agency's estimate of the burden of the
proposed collection of information; (c) ways to enhance the quality,
utility, and clarity of the information to be collected; (d) ways to
minimize the burden of the collection of information on respondents,
including through the use of automated collection techniques or other
forms of information technology; and (e) estimates of capital or start-
up costs and costs of operation, maintenance, and purchase of services
to provide information. Burden means the total time, effort, or
financial resources expended by persons to generate, maintain, retain,
disclose or provide information to or for a Federal agency. This
includes the time needed to review instructions; to develop, acquire,
install and utilize technology and systems for the purpose of
collecting, validating and verifying information, processing and
maintaining information, and disclosing and providing information; to
train personnel and to be able to respond to a collection of
information, to search data sources, to complete and review the
collection of information; and to transmit or otherwise disclose the
information.
Proposed Project
Paul Coverdell National Acute Stroke Program (PCNASP)--New--
National Center for Chronic Disease Prevention and Health Promotion
(NCCDPHP), Centers for Disease Control and Prevention (CDC).
Background and Brief Description
Stroke is the fifth leading cause of death in the United States and
results in approximately 130,000 deaths per year. Additionally,
approximately 800,000 stroke events are reported each year, including
approximately 250,000 recurrent strokes. However, many strokes are
preventable, or their severity can be reduced through coordinated care
that is delivered in a timely manner.
Stroke outcomes depend upon the rapid recognition of signs and
symptoms of stroke, prompt transport to a treatment facility, and early
rehabilitation. Improving outcomes requires a coordinated systems
approach involving pre-hospital care, emergency department and hospital
care, rehabilitation, prevention of complications, and ongoing
secondary prevention. Each care setting has unique opportunities for
improving the quality of care provided and access to available
professional and clinical care at the local level within a coordinated
state-based system of care.
Through the Paul Coverdell National Acute Stroke Program (PCNASP),
CDC has been continuously working to measure and improve acute stroke
care using well-known quality improvement strategies coupled with
frequent evaluation of results. PCNASP awardees are state health
departments who work with participating hospitals and EMS agencies in
their jurisdictions to improve quality of care for stroke patients.
State-based efforts include identifying effective stroke treatment
centers and building capacity and infrastructure to ensure that stroke
patients are routed to effective treatment centers in a timely manner.
During initial cooperative agreement cycles, PCNASP awardees
focused on in-hospital quality of care (QoC) issues with technical
assistance provided by CDC. Through lessons learned during this process
and other supporting evidence in the field, it has become evident that
it is also important to examine pre- and post-hospital transitions of
care to link the entire continuum of stroke care when improving QoC for
stroke patients.
The PCNASP will continue under a new five-year cooperative
agreement, subject to available funding, to begin on or around July 1,
2015. The new funding period reflects additional emphasis on pre-
hospital quality of care as well as the post-hospital transition of
care setting from hospital to home and the next care provider.
Therefore, awardees will systematically collect and report data on
hospital capacity and all three phases of the stroke care continuum.
The new cooperative agreement funding cycle will include pre-
hospital (EMS), in-hospital, and post-hospital patient care data. Data
to be collected for pre- and in-hospital care closely align with
standards of The Joint Commission (TJC), the American Heart
Association's Get With The Guidelines (GWTG) program, and the National
Emergency Medical Services Information System (NEMSIS). CDC and
awardees will work on defining performance measures for the post-
hospital transition of care setting. Data from these three settings
will be transmitted from the awardees to CDC quarterly. The average
burden per response for this data will vary between 30-90 minutes. The
burden will be 30 minutes each for independent submission of
information relating to the pre-hospital, in-hospital, and post-
hospital phases of patient care. Alternatively, the burden will be 90
minutes for awardees who transmit pre-, in-, and post-hospital data as
one combined file. CDC accepts file transmissions as individual phases
or combined.
In addition, the new cooperative agreement funding cycle will also
include primary data collection of hospital inventory data to
understand the capacity and infrastructure of the hospitals that admit
and treat stroke patients. Each hospital will report inventory
information to its PCNASP awardee annually. The average burden per
response is 15 minutes. In addition, each PCNASP awardee will prepare
an annual aggregate hospital inventory file for transmission to CDC.
The average burden of reporting hospital inventory information for each
PCNASP awardee is 8 hours per response. All patient, hospital, and EMS
provider data that is submitted to CDC by PCNASP awardees will be de-
identified and occur through secure data systems.
Proposed data elements and quality indicators may be updated over
time to include new or revised items based on evolving recommendations
and standards in the field to improve the quality of stroke care.
OMB approval is requested for three years. All information is
submitted to CDC electronically. Participation is voluntary and there
are no costs to respondents other than their time.
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Estimated Annualized Burden Hours
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Average
Number of Number of burden per Total burden
Type of respondent Form name respondents responses per response (in (in hrs.)
respondent hrs.)
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PCNASP Awardee................ Hospital 9 1 8 72
Inventory.
In-hospital care 9 4 30/60 18
data.
Pre-hospital 9 4 30/60 18
care data.
Post-hospital 9 4 30/60 18
transition of
care data.
Hospital...................... Hospital 400 1 15/60 100
Inventory.
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Total..................... ................ .............. .............. .............. 226
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Leroy A. Richardson,
Chief, Information Collection Review Office, Office of Scientific
Integrity, Office of the Associate Director for Science, Office of the
Director, Centers for Disease Control and Prevention.
[FR Doc. 2015-17699 Filed 7-17-15; 8:45 am]
BILLING CODE 4163-18-P