[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]]

-----------------------------------------------------------------------

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.

-----------------------------------------------------------------------

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 
Hearts[supreg] 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: [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 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 Hearts[supreg] 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 Hearts[supreg] 
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 Hearts[supreg] 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 Hearts[supreg] 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[supreg] Hypertension Control 
Champions.
    In 2013, 2014, and 2015, CDC collected information needed to assess 
candidates for recognition through the Million Hearts[supreg] 
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 Hearts[supreg] 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 Hearts[supreg] 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 Hearts[supreg] 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[supreg] 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[supreg] 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
----------------------------------------------------------------------------------------------------------------
                                                                                         Average
                                                          Number of      Number of     burden per   Total burden
        Type of respondent              Form name        respondents   responses per  response (in    (in hrs.)
                                                                        respondent        hrs.)
----------------------------------------------------------------------------------------------------------------
Physicians (Single or Group        Million                       500               1            .5           250
 Practices).                        Hearts[supreg]
                                    Hypertension
                                    Control Champion
                                    Nomination form.
Finalists........................  Data Verification              40               1             1            40
                                    Form.
Selected Champion................  Semi-structured                40               1             2            80
                                    Interview.
                                                       ---------------------------------------------------------
    Total........................  ...................  ............  ..............  ............           370
----------------------------------------------------------------------------------------------------------------


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]
 BILLING CODE P