[Federal Register Volume 85, Number 233 (Thursday, December 3, 2020)]
[Notices]
[Pages 78133-78135]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-26632]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[60Day-21-1108; Docket No. CDC-2020-0119]


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.

-----------------------------------------------------------------------

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 the existing 
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 February 1, 2021.

ADDRESSES: You may submit comments, identified by Docket No. CDC-2020-
0119 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 Jeffrey M. Zirger, Information Collection 
Review Office, Centers for Disease Control and Prevention, 1600 Clifton 
Road NE, MS-D74, Atlanta, Georgia 30329; phone: 404-639-7118; 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 Control 
No. 0920-1108, Exp. 09/30/2022)--Revision--National Center for Chronic 
Disease Prevention and Health Promotion (NCCDPHP), Centers for Disease 
Control and Prevention (CDC).

[[Page 78134]]

Background and Brief Description

    Stroke is the fifth leading cause of death in the United States and 
results in approximately 145,000 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. In addition, there remains a 
need to identify disparities in stroke care and implement stroke 
interventions, such as community education and quality improvement 
activities, focused on priority populations.
    Through the Paul Coverdell National Acute Stroke Program (PCNASP), 
CDC has been continuously worked to measure and improve acute stroke 
care using well-known quality improvement strategies coupled with 
frequent evaluation of results. There remains a national need to 
understand best practices of stroke systems of care, which includes 
prevention and awareness, use of EMS, in-hospital care, and 
rehabilitation and recovery. PCNASP awardees work statewide with 
participating hospitals, Emergency Medical Services (EMS) agencies, and 
other healthcare partners (e.g., community clinical partners) to 
improve quality of care for stroke patients. These efforts include 
implementing strategies to close the gap on stroke disparities, 
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 state health department 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 Control No. 0920-1108, Exp. 09/30/
2022). CDC plans to request a revision of this currently approved 
collection, with an extension of three years, reflecting a new Notice 
of Funding Opportunity (NOFO). The new PCNASP cooperative agreements 
will be expanded to include 13 awardees, which will be awarded on or 
about July 1, 2021.
    In-hospital patient care data will continue to align with standards 
set by The Joint Commission (TJC) and the American Heart Association's 
Get With The Guidelines (GWTG) program. Estimated burden for the 
collection of in-hospital data will increase by a net increase of eight 
hours due to added program awardees under the new cooperative 
agreement. The average burden per response remains 30 minutes for 
awardees, for a total of 26 hours annually.
    Data collection methods for pre-hospital care will continue to be 
collected similar to the two current methods, depending on awardees' 
access to data sources. These two methods are existing data systems 
currently available to awardees, including the AHA's GWTG and the 
National Emergency Medical Services Information System (NEMSIS). CDC 
has worked to reduce the overall number of required data elements and 
identified areas of alignment with AHA's GWTG. Total average burden 
will decrease due to the reduction in data elements under the new NOFO. 
Depending on the awardees' access to data sources (GWTG or NEMSIS), the 
average burden per response will vary from 30 minutes to one hour. 
Thus, the burden for pre-hospital data is estimated to decrease from 60 
to 46 burden hours annually.
    Under scope of the new NOFO, patient level quality of care post-
hospital data will not be collected. Post-stroke transitions of care, 
rehabilitation, follow-up, etc. will be assessed in alignment with 
existing CDC cooperative agreements. This is an effort to better align 
resources, funding, and community efforts already working to connect 
stroke patients with post-acute clinical care. As a result, burden for 
this collection and transmission will not be included in the overall 
estimation of average burden.
    Primary data collection of hospital inventory data will continue to 
be collected 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 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 8 hours 
per response. Based on current data and expected number of awardees 
under new NOFO, we are estimating the number of hospital partners per 
awardee to be 50 hospitals. Due to this increase in awardees, the 
estimated number of hospital respondents is anticipated to increasing 
from 378 to 650. Thus, there is a net increase of 136 hours for 
hospitals to collect and transmit this data. The total burden for 
hospital inventory data is increasing from 189 to 325 hours annually.
    These requested changes will result in a net increase in total 
average burden from 361 to 501 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.

[[Page 78135]]



                                        Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
                                                                                      Average
                                                     Number of       Number of      burden per     Total burden
      Type of respondents           Form name       respondents    responses per   response  (in    (in hours)
                                                                    respondent        hours)
----------------------------------------------------------------------------------------------------------------
PCNASP Awardee................  Hospital                      13               1               8             104
                                 inventory.
                                In-hospital care              13               4           30/60              26
                                 data.
                                Pre-hospital                   3               4           30/60               6
                                 care data.
                                                              10               4               1              40
PCNASP Hospital Partners......  Hospital                     650               1           30/60             325
                                 Inventory.
                               ---------------------------------------------------------------------------------
    Total.....................  ................  ..............  ..............  ..............             501
----------------------------------------------------------------------------------------------------------------


Jeffrey M. Zirger,
Lead, Information Collection Review Office, Office of Scientific 
Integrity, Office of Science, Centers for Disease Control and 
Prevention.
[FR Doc. 2020-26632 Filed 12-2-20; 8:45 am]
BILLING CODE 4163-18-P