2019-01336. 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 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: [phone]; Email: [e-mail].

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 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

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

Jeffrey M. Zirger,

Acting Lead, Information Collection Review Office, Office of Scientific Integrity, Office of Science, Centers for Disease Control and Prevention.