Proposed Data Collection Submitted for Public Comment and Recommendations

Federal Register, Volume 83 Issue 238 (Wednesday, December 12, 2018)

Federal Register Volume 83, Number 238 (Wednesday, December 12, 2018)

Notices

Pages 63890-63891

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

FR Doc No: 2018-26876

Page 63890

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

60Day-19-0976; Docket No. CDC-2018-0112

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 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 Million Heartssupreg Hypertension Control Challenge, a 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 of successful strategies to control hypertension.

DATES: CDC must receive written comments on or before February 11, 2019.

ADDRESSES: You may submit comments, identified by Docket No. CDC-2018-

0112 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 Jeffrey M. Zirger, Information Collection Review Office, Centers for Disease Control and Prevention, 1600 Clifton Road, NE, MS-D74, Atlanta, Georgia 30329; phone: 404-639-7570; Email: email protected.

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

Million Heartssupreg Hypertension Control Challenge (OMB No. 0920-0976, exp. 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 75 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 Heartssupreg initiative to prevent one million heart attacks and strokes by 2017. In January 2018, CDC launched Million Heartssupreg 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 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 additional 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.

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

Page 63891

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', practices', or healthcare systems' 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.

Finalists who pass the data verification and validation process and background check will be reviewed by a CDC panel of judges to determine the Champion status. Several Champions will be asked to 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 2017, CDC recognized a total of 83 public and private health care practices and systems as Million Heartssupreg 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 continue the Million Heartssupreg Hypertension Control Challenge through 2022 with revisions. 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 Renewal 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 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 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 for a revision is requested for three years. CDC estimates that up to 200 applicants will submit an application covered by this information collection each year. It is estimated that information collection activities will total 215 burden hours per year. This represents a decrease in the estimated annualized burden hours from 370 hours to 215 hours. There is no cost to respondents other than their time.

Estimated Annualized Burden Hours

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Number of Average burden

Type of respondents Form name Number of responses per per response Total burden

respondents respondent (in hours) (in hours)

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Physicians, Practices, and Million 200 1 30/60 100

healthcare systems. Heartssupreg

Hypertension

Control

Champion

Application

form.

Finalists..................... Data 40 1 2 80

Verification

Form.

Champions..................... Semi-structured 35 1 1 35

interview guide.

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Total..................... ................ .............. .............. .............. 215

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Jeffrey M. Zirger,

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

FR Doc. 2018-26876 Filed 12-11-18; 8:45 am

BILLING CODE 4163-18-P

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