80 FR 42820 - Proposed Data Collection Submitted for Public Comment and Recommendations

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention

Federal Register Volume 80, Issue 138 (July 20, 2015)

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.

[Federal Register Volume 80, Number 138 (Monday, July 20, 2015)]
[Notices]
[Pages 42820-42822]
From the Federal Register Online  [www.thefederalregister.org]
[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.

[[Page 42822]]



                                        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.)
----------------------------------------------------------------------------------------------------------------
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.
                                                 ---------------------------------------------------------------
    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