[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]
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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.
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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 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
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Average
Number of Number of burden per Total burden
Type of respondents Form name respondents responses per response (in (in hours)
respondent hours)
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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.
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Total..................... ................ .............. .............. .............. 501
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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]
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