Agency Forms Undergoing Paperwork Reduction Act Review

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Federal RegisterApr 26, 2021
86 Fed. Reg. 22055 (Apr. 26, 2021)

In accordance with the Paperwork Reduction Act of 1995, the Centers for Disease Control and Prevention (CDC) has submitted the information collection request titled Paul Coverdell National Acute Stroke Program (PCNASP) to the Office of Management and Budget (OMB) for review and approval. CDC previously published a “Proposed Data Collection Submitted for Public Comment and Recommendations” notice on December 3, 2020 to obtain comments from the public and affected agencies. CDC did not receive comments related to the previous notice. This notice serves to allow an additional 30 days for public and affected agency comments.

CDC will accept all comments for this proposed information collection project. The Office of Management and Budget is particularly interested in comments that:

(a) 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;

(b) Evaluate the accuracy of the agencies estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used;

(c) Enhance the quality, utility, and clarity of the information to be collected;

(d) 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 submission of responses; and

(e) Assess information collection costs.

To request additional information on the proposed project or to obtain a copy of the information collection plan and instruments, call (404) 639-7570. Comments and recommendations for the proposed information collection should be sent within 30 days of publication of this notice to www.reginfo.gov/public/do/PRAMain Find this particular information collection by selecting “Currently under 30-day Review—Open for Public Comments” or by using the search function. Direct written comments and/or suggestions regarding the items contained in this notice to the Attention: CDC Desk Officer, Office of Management and Budget, 725 17th Street NW, Washington, DC 20503 or by fax to (202) 395-5806. Provide written comments within 30 days of notice publication.

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).

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. 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.

Through the Paul Coverdell National Acute Stroke Program (PCNASP), CDC has 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.

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 agreement 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 similarly 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 the scope of the new NOFO, patient level post-hospital quality of care data will not be collected. Post-stroke transitions of care, rehabilitation, and follow-up will be assessed in alignment with existing CDC cooperative agreements, such as supporting the development of approaches to link patients with community resources and clinical services through CDC-RFA-DP18-1817. 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 eight hours per response. Based on current data and expected number of awardees under the 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 increase 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. CDC requests approval for an estimated 501 annualized burden hours. 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)
PCNASP Awardee Hospital inventory 13 1 8
In-hospital care data 13 4 30/60
Pre-hospital care data 3 10 4 4 30/60 1
PCNASP Hospital Partners Hospital Inventory 650 1 30/60

Jeffrey M. Zirger,

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

[FR Doc. 2021-08573 Filed 4-23-21; 8:45 am]

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