[Federal Register Volume 84, Number 26 (Thursday, February 7, 2019)]
[Notices]
[Pages 2510-2512]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-01336]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[60-Day-19-1108; Docket No. CDC-2018-0117]


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 effort to reduce public burden and maximize the 
utility of government information, invites the general public and other 
Federal agencies the opportunity to comment on a proposed and/or 
continuing information collection, as required by the Paperwork 
Reduction Act of 1995. This notice invites comment on a proposed 
information collection project titled 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: CDC must receive written comments on or before April 8, 2019.

ADDRESSES: You may submit comments, identified by Docket No. CDC-2018-
0117 by any of the following methods:
     Federal eRulemaking Portal: Regulations.gov. Follow the 
instructions for submitting comments.
     Mail: Jeffrey M. Zirger, 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. CDC will post, without change, all relevant comments 
to Regulations.gov.
    Please note: Submit all comments 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 Leroy A. Richardson, 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 
proposed collection, each proposed extension of existing collection of 
information, and each reinstatement of previously approved information 
collection before submitting the collection to the OMB for approval. To 
comply with this requirement, we are publishing this notice of a 
proposed data collection as described below.
    The OMB is particularly interested in comments that will help:
    1. Evaluate whether the proposed collection of information is 
necessary for the proper performance of the functions of the agency, 
including whether the information will have practical utility;
    2. Evaluate the accuracy of the agency's estimate of the burden of 
the proposed collection of information, including the validity of the 
methodology and assumptions used;
    3. Enhance the quality, utility, and clarity of the information to 
be collected; and
    4. Minimize the burden of the collection of information on those 
who are to respond, including through the use of appropriate automated, 
electronic, mechanical, or other technological collection techniques or 
other forms of information technology, e.g., permitting electronic 
submissions of responses.
    5. Assess information collection costs.

Proposed Project

    Paul Coverdell National Acute Stroke Program (PCNASP) (OMB No. 
0920-1108, exp. 03/31/2019)--Revision--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 patient outcomes post-stroke can be improved through 
coordinated care that begins at stroke onset and 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, post-stroke 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, Emergency

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Medical Services (EMS) agencies, and other healthcare partners (e.g., 
post-stroke recovery facilities) in their jurisdictions to improve 
quality of care for stroke patients. State-based efforts include 
identifying effective stroke treatment centers, building capacity and 
infrastructure to ensure that stroke patients are routed to effective 
treatment centers in a timely manner, and improving transitions of care 
from the hospital to the next care setting.
    During initial cooperative agreement cycles, PCNASP awardees 
focused on improving in-hospital quality of care (QoC) 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's current five-year cooperative agreement started on 
July 1, 2015 and includes nine awardees and their selected partners 
(hospitals, EMS agencies, other healthcare facilities). This current 
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 or other healthcare facility. With technical 
assistance provided by CDC, awardees have worked on identifying and 
using data systems to systematically collect and report data on all 
three phases of the stroke care continuum and on hospital capacity.
    PCNASP currently has OMB approval for the collection of pre-
hospital (EMS), in-hospital, and post-hospital patient care data, as 
well as hospital inventory data (OMB No. 0920-1108, exp. 03/31/2019). 
CDC plans to request a revision of this currently approved collection, 
with an extension of three years.
    In-hospital patient care data continues to align with standards set 
by The Joint Commission (TJC) and the American Heart Association's Get 
With The Guidelines (GWTG) program. There are no changes to the 
estimated burden for the collection of in-hospital data. The average 
burden per response remains 30 minutes for awardees, for a total of 18 
hours annually.
    Data collection methods for pre- and post-hospital care data are 
being revised to allow for information collection through existing data 
systems, including GWTG and the National Emergency Medical Services 
Information System (NEMSIS). CDC has been working with awardees and the 
American Heart Association to identify areas of alignment and new 
collaboration to reduce the burden of this data collection. The changes 
also reflect the different methods that awardees use to collect this 
data, which depends on their state's access to data sources. These 
changes will ultimately reduce the overall burden of pre-hospital data 
collection by using existing data systems to automatically transmit 
data from EMS partners or hospitals to awardees. The average burden per 
response will vary from 30 minutes to two hours. Thus, the burden for 
pre-hospital data is being reduced from 96 to 60 burden hours annually.
    Similarly, the burden for post-hospital data is reduced from 38 to 
22 burden hours annually, because data collection will occur using GWTG 
or another similar mechanism, and data will be transmitted 
automatically to awardees. The average burden per response will vary 
from 30 minutes to two hours per quarter for post-hospital data 
collection.
    Primary data collection of hospital inventory data is being 
collected to understand the capacity and infrastructure of the 
hospitals that admit and treat stroke patients. Each hospital reports 
inventory information to its PCNASP awardee annually. The average 
burden per response remains 30 minutes for hospitals. In addition, each 
PCNASP awardee prepares an annual aggregate hospital inventory file for 
transmission to CDC. The average burden of reporting hospital inventory 
information for each PCNASP awardee remains eight hours per response. 
The number of respondents is increasing from 315 to 378 hospital 
partners due to increased participation in PCNASP. Thus, the burden for 
hospital inventory data is increasing from 230 to 261 hours annually.
    These requested changes will result in a net decrease in total 
average burden from 382 to 361 hours. 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. Participation is 
voluntary and there are no costs to respondents other than their time.

                                        Estimated Annualized Burden Hours
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                                                                     Number of    Average burden
      Type of respondents           Form name        Number of     responses per   per response    Total burden
                                                    respondents     respondent      (in hours)      (in hours)
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PCNASP Awardee................  Hospital                       9               1               8              72
                                 inventory.
                                In-hospital care               9               4           30/60              18
                                 data.
                                Pre-hospital                   2               4           30/60               4
                                 care data.                    7               4               2              56
                                Post-hospital                  7               4           30/60              14
                                 transition of                 2               4               1               8
                                 care data.
PCNASP Hospital Partners......  Hospital                     378               1           30/60             189
                                 Inventory.
                                                 ---------------------------------------------------------------
    Total.....................  ................  ..............  ..............  ..............             361
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[[Page 2512]]

Jeffrey M. Zirger,
Acting Lead, Information Collection Review Office, Office of Scientific 
Integrity, Office of Science, Centers for Disease Control and 
Prevention.
[FR Doc. 2019-01336 Filed 2-6-19; 8:45 am]
 BILLING CODE 4163-18-P