2019-17287. Agency Forms Undergoing Paperwork Reduction Act Review

In accordance with the Paperwork Reduction Act of 1995, the Centers for Disease Control and Prevention (CDC) has submitted the information collection request titled Million Hearts Hypertension Control Challenge 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 12, 2018 to obtain comments from the public and affected agencies. CDC received two comments. We thank the respondents for these comments. 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 [phone] or send an email to [e-mail]. 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 [phone]. Provide written comments within 30 days of notice publication.

Proposed Project

Million Hearts Hypertension Control Challenge (OMB Control Number 0920-0976, Expiration 12/31/2019)—Revision—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 78 million American adults have high blood pressure but only about half (48%) have adequately controlled blood pressure. The costs of hypertension are estimated at $48.9 billion annually in direct medical costs.

In September 2011, CDC launched the Million Hearts initiative to prevent one million heart attacks and strokes by 2017. In January 2018, CDC launched Million Hearts 2022 to continue to prevent one million heart attacks, strokes, and related health conditions. In order to achieve this goal, at least 10 million more Americans must have their blood pressure under control. Million Hearts 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 additional information is needed to fully understand implementation practices so that they can be shared and promoted.

In 2013, CDC launched the Million Hearts 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 Hearts Hypertension Control Champions.

Interested clinicians or practices complete a web-based application form which collects the minimum amount of data needed to demonstrate hypertension control among their adult patients, 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 brief description of the characteristics 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 application form is 30 minutes. CDC scientists or contractors review each application form and rank applications by reported hypertension control rate.

In the second phase of assessment, applicants with the highest preliminary scores are asked to participate in a two-hour data verification and validation process. The applicant reviews the application form with a reviewer, describes how information was obtained from the providers' (or practices') electronic records, chart reviews, or other sources, and reviews the methodology used to calculate the reported hypertension control rate. Data verification and validation is conducted to ensure that all applicants meet eligibility criteria and assure accuracy of their reported hypertension control rate according to a standardized method. Applicants must have achieved a hypertension control rate of at least 80% among their adult patients aged 18-85 years with hypertension.

Up to 35 finalists who pass the data verification and background check are selected as Champions. Several Champions participate in a one-hour, semi-structured interview and provide 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 through 2018, CDC recognized a total of 101 public and private health care practices and systems as Million Hearts® Hypertension Control Champions. The Champions are announced roughly annually, approximately six months after the Challenge application period ends. The current OMB approval for information collection expires December 31, 2019.

CDC plans to conduct the Million Hearts Hypertension Control Challenge annually through 2022. The 2020 Challenge is planned to launch in February 2020, coinciding with American Heart Month. The application period will be open for approximately 45-60 days, with recognition of the 2020 Champions in the fall of 2020. A similar calendar year schedule is planned for 2021 and 2022. Revision for 2020, 2021, and 2022 includes a reduction in the estimated number of respondents. During the period of this revision request, on an annual basis, CDC estimates that information will be collected from up to 200 applicants using the application form, at most 40 data verifications, and at most 35 semi-structured interviews. There is an overall reduction in estimated annualized burden hours.

The overall goal of the Million Hearts 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 Hearts 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 Hearts Hypertension Control Challenge will link success in clinical outcomes of hypertension control with information about strategies 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. The total estimated annualized burden hours are 215. There are no costs to the 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 hr)
Clinicians, practices, and healthcare systems	Million Hearts® Hypertension Control Champion Application form	200	1	30/60
Finalists	Data Verification Form	40	1	2
Champions	Semi-structured interview guide	35	1	1

Jeffrey M. Zirger,

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