Proposed Data Collection Submitted for Public Comment and Recommendations

Federal Register, Volume 81 Issue 87 (Thursday, May 5, 2016)

Federal Register Volume 81, Number 87 (Thursday, May 5, 2016)

Notices

Pages 27136-27137

From the Federal Register Online via the Government Publishing Office www.gpo.gov

FR Doc No: 2016-10507

Page 27136

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

60Day-16-0976; Docket No. CDC-2016-0042

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 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 Million Heartssupreg Hypertension Control Challenge, program designed to identify clinical practices and health systems that have been successful in achieving high rates of hypertension control and to develop models for dissemination.

DATES: Written comments must be received on or before July 5, 2016.

ADDRESSES: You may submit comments, identified by Docket No. CDC-2016-

0042 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.

Please note:

All public comment should be submitted 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 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: omb@cdc.gov.

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 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.

Proposed Project

Million Heartssupreg Hypertension Control Challenge (OMB No. 0920-0976, exp. 7/31/2016)--Reinstatement with Change--National Center for Chronic Disease Prevention and Health Promotion (NCCDPHP), Centers for Disease Control and Prevention (CDC).

Background and Brief Description

Cardiovascular disease is a leading cause of death for men and women in the United States, among the most costly health problems facing our nation today, and among the most preventable. Heart disease and stroke also contribute significantly to disability. High blood pressure, also known as hypertension, is one of the leading causes of heart disease and stroke. Currently, about 75 million American adults have high blood pressure but only about half (54%) have adequately controlled blood pressure. The costs of hypertension are estimated at $48.6 billion annually, including the cost of direct medical expenses and the cost of lost productivity.

In September 2011, CDC launched the Million Heartssupreg initiative to prevent one million heart attacks and strokes by 2017. In order to achieve this goal, at least 10 million more Americans must have their blood pressure under control. Million Heartssupreg is working to reach this goal through the promotion of clinical practices that are effective in increasing blood pressure control among patient populations. There is scientific evidence that provides general guidance on the types of system-based changes to clinical practice that can improve patient blood pressure control, but more information is needed to fully understand implementation practices so that they can be shared and promoted.

In 2013, CDC launched the Million Heartssupreg Hypertension Control Challenge, authorized by Public Law 111-358, the America Creating Opportunities to Meaningfully Promote Excellence in Technology, Education and Science Reauthorization Act of 2010 (COMPETES Act). The Challenge is designed to help CDC (1) identify clinical practices and health systems that have been successful in achieving high rates of hypertension control, and (2) develop models for dissemination. The Challenge is open to single practice providers, group practice providers, and healthcare systems. Providers whose hypertensive population achieves exemplary levels of hypertension control are recognized as Million Heartssupreg Hypertension Control Champions.

In 2013, 2014, and 2015, CDC collected information needed to assess candidates for recognition through the Million Heartssupreg Hypertension Control Challenge. First, interested providers or practices completed a web-based nomination form which collected the minimum amount of data needed to

Page 27137

provide evidence of clinical success in achieving hypertension control, including: (a) Two point-in-time measures of the clinical hypertension control rate for the patient population, (b) the size of the clinic population served, (c) a description of the patient population served and geographic location, and (d) a description of the sustainable systems and strategies adopted to achieve and maintain hypertension control rates. The estimated burden for completing the nomination form was 30 minutes. CDC scientists or contractors reviewed each nomination form and assigned a preliminary score.

In the second phase of assessment, nominees with the highest preliminary scores were asked to participate in a one-hour data verification process. The nominee reviewed the nomination form with a reviewer or abstractor, described how information was obtained from the providers' (or practices') electronic records, chart reviews, or other sources, and reviewed the methodology used to calculate the reported hypertension control rate. Data verification was conducted to ensure that all nominees met eligibility criteria and calculated their reported hypertension control rate according to a standardized method.

In the third phase of the assessment, each remaining finalist participated in a two-hour, semi-structured interview and provided detailed information about the patient population served, the geographic region served, and the strategies employed by the practice or health system to achieve exemplary rates of hypertension control, including barriers and facilitators for those strategies. Based on the information collected for Challenges in 2013 and 2014, CDC recognized a total of 39 public and private health care practices and systems as Million Heartssupreg Hypertension Control Champions. The Champions were announced in 2014 and 2015, approximately six months after each Challenge was launched. Information collection has been completed for the 2015 Challenge, but Champions have not yet been announced (as of April 27, 2016). The Challenge was not conducted in 2016. The current OMB approval for information collection expires July 31, 2016.

CDC plans to reinstate the Million Heartssupreg Hypertension Control Challenge, with changes, for 2017, 2018, and 2019. Challenges were previously launched in late summer/early fall. The 2017 Challenge will launch in February 2017, coinciding with American Heart Month. The nomination period will be open for approximately 60 days, with recognition of the 2017 Champions in the fall of 2017. A similar calendar year schedule is planned for 2018 and 2019. Additional changes for 2017, 2018, and 2019 include minor changes to the nomination and data verification forms to improve usability and data quality; elimination of the cash prize for Champions; and changes in the estimated number of respondents. During the period of this Reinstatement request, on an annual basis, CDC estimates that information will be collected from up to 500 nominees using the nomination form, at most 40 data verifications, and at most 40 semi-

structured interviews. There is an overall reduction in estimated annualized burden hours.

The overall goal of the Million Heartssupreg initiative is to prevent one million heart attacks and strokes, and controlling hypertension is one focus of the initiative. CDC will use the information collected through the Million Heartssupreg Hypertension Control Challenge to increase widespread attention to hypertension at the clinical practice level, improve understanding of successful and sustainable implementation strategies at the practice or health system level, bring visibility to organizations that invest in hypertension control, and motivate individual practices to strengthen their hypertension control efforts. Information collected through the Million Heartssupreg Hypertension Control Challenge will link success in clinical outcomes of hypertension control with information about procedures that can be used to achieve similar favorable outcomes so that the strategies can be replicated by other providers and health care systems.

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

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Average

Number of Number of burden per Total burden

Type of respondent Form name respondents responses per response (in (in hrs.)

respondent hrs.)

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Physicians (Single or Group Million 500 1 .5 250

Practices). Heartssupreg

Hypertension

Control Champion

Nomination form.

Finalists........................ Data Verification 40 1 1 40

Form.

Selected Champion................ Semi-structured 40 1 2 80

Interview.

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Total........................ ................... ............ .............. ............ 370

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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. 2016-10507 Filed 5-4-16; 8:45 am

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