This PDF is the current document as it appeared on Public Inspection on 07/17/2015 at 08:45 am.
Centers for Disease Control and Prevention (CDC), Department of Health and Human Services (HHS).
Notice with comment period.
The Centers for Disease Control and Prevention (CDC), as part of its continuing efforts to reduce public burden and maximize the utility of government information, invites the general public and other Federal agencies to take this opportunity to comment on proposed and/or continuing information collections, as required by the Paperwork Reduction Act of 1995. This notice invites comment on the 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.
Written comments must be received on or before September 18, 2015.
You may submit comments, identified by Docket No. CDC-2015-0056 by any of the following methods:
Federal eRulemaking Portal: Regulation.gov. Follow the instructions for submitting comments.
Mail: Leroy A. Richardson, 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. All relevant comments received will be posted without change to Regulations.gov, including any personal information provided. For access to the docket to read background documents or comments received, go to Regulations.gov.
All public comment should be submitted through the Federal eRulemaking portal (Regulations.gov) or by U.S. mail to the address listed above.Start Further Info
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 the Information Collection Review Office, Centers for Disease Control and Prevention, 1600 Clifton Road NE., MS-D74, Atlanta, Georgia 30329; phone: 404-639-7570; Email: firstname.lastname@example.org.End Further Info End Preamble Start Supplemental 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 Start Printed Page 42821proposed collection, each proposed extension of existing collection of information, and each reinstatement of previously approved information collection before submitting the collection to OMB for approval. To comply with this requirement, we are publishing this notice of a proposed data collection as described below.
Comments are invited on: (a) Whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information shall have practical utility; (b) the accuracy of the agency's estimate of the burden of the proposed collection of information; (c) ways to enhance the quality, utility, and clarity of the information to be collected; (d) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques or other forms of information technology; and (e) estimates of capital or start-up costs and costs of operation, maintenance, and purchase of services to provide information. Burden means the total time, effort, or financial resources expended by persons to generate, maintain, retain, disclose or provide information to or for a Federal agency. This includes the time needed to review instructions; to develop, acquire, install and utilize technology and systems for the purpose of collecting, validating and verifying information, processing and maintaining information, and disclosing and providing information; to train personnel and to be able to respond to a collection of information, to search data sources, to complete and review the collection of information; and to transmit or otherwise disclose the information.
Paul Coverdell National Acute Stroke Program (PCNASP)—New—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 their severity can be reduced through coordinated care that 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, 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 and EMS agencies in their jurisdictions to improve quality of care for stroke patients. State-based efforts include identifying effective stroke treatment centers and building capacity and infrastructure to ensure that stroke patients are routed to effective treatment centers in a timely manner.
During initial cooperative agreement cycles, PCNASP awardees focused on in-hospital quality of care (QoC) issues 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 will continue under a new five-year cooperative agreement, subject to available funding, to begin on or around July 1, 2015. The new 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 and the next care provider. Therefore, awardees will systematically collect and report data on hospital capacity and all three phases of the stroke care continuum.
The new cooperative agreement funding cycle will include pre-hospital (EMS), in-hospital, and post-hospital patient care data. Data to be collected for pre- and in-hospital care closely align with standards of The Joint Commission (TJC), the American Heart Association's Get With The Guidelines (GWTG) program, and the National Emergency Medical Services Information System (NEMSIS). CDC and awardees will work on defining performance measures for the post-hospital transition of care setting. Data from these three settings will be transmitted from the awardees to CDC quarterly. The average burden per response for this data will vary between 30-90 minutes. The burden will be 30 minutes each for independent submission of information relating to the pre-hospital, in-hospital, and post-hospital phases of patient care. Alternatively, the burden will be 90 minutes for awardees who transmitpre-, in-, and post-hospital data as one combined file. CDC accepts file transmissions as individual phases or combined.
In addition, the new cooperative agreement funding cycle will also include primary data collection of hospital inventory data 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 is 15 minutes. In addition, each PCNASP awardee will prepare an annual aggregate hospital inventory file for transmission to CDC. The average burden of reporting hospital inventory information for each PCNASP awardee is 8 hours per response. 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. All information is submitted to CDC electronically. Participation is voluntary and there are no costs to respondents other than their time.Start Printed Page 42822
|Type of respondent||Form name||Number of respondents||Number of responses per respondent||Average burden per response (in hrs.)||Total burden (in hrs.)|
|PCNASP Awardee||Hospital Inventory||9||1||8||72|
|In-hospital care data||9||4||30/60||18|
|Pre-hospital care data||9||4||30/60||18|
|Post-hospital transition of care data||9||4||30/60||18|
Leroy A. Richardson,
Chief, Information Collection Review Office, Office of Scientific Integrity, Office of the Associate Director for Science, Office of the Director, Centers for Disease Control and Prevention.
[FR Doc. 2015-17699 Filed 7-17-15; 8:45 am]
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