Federal Register Notice

27136

Federal Register / Vol. 81, No. 87 / Thursday, May 5, 2016 / Notices

DEPARTMENT OF HEALTH AND
HUMAN SERVICES

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Centers for Disease Control and
Prevention

Clifton Road NE., MS–D74, Atlanta,
Georgia 30329; phone: 404–639–7570;
Email: [email protected].

Under the
Paperwork Reduction Act of 1995 (PRA)
[60Day–16–0976; Docket No. CDC–2016–
(44 U.S.C. 3501–3520), Federal agencies
0042]
must obtain approval from the Office of
Management and Budget (OMB) for each
Proposed Data Collection Submitted
collection of information they conduct
for Public Comment and
or sponsor. In addition, the PRA also
Recommendations
requires Federal agencies to provide a
AGENCY: Centers for Disease Control and 60-day notice in the Federal Register
Prevention (CDC), Department of Health concerning each proposed collection of
information, including each new
and Human Services (HHS).
proposed collection, each proposed
ACTION: Notice with comment period.
extension of existing collection of
SUMMARY: The Centers for Disease
information, and each reinstatement of
Control and Prevention (CDC), as part of previously approved information
its continuing efforts to reduce public
collection before submitting the
burden and maximize the utility of
collection to OMB for approval. To
government information, invites the
comply with this requirement, we are
general public and other Federal
publishing this notice of a proposed
agencies to take this opportunity to
data collection as described below.
comment on proposed and/or
Comments are invited on: (a) Whether
continuing information collections, as
the proposed collection of information
required by the Paperwork Reduction
is necessary for the proper performance
Act of 1995. This notice invites
of the functions of the agency, including
®
comment on the Million Hearts
whether the information shall have
Hypertension Control Challenge,
practical utility; (b) the accuracy of the
program designed to identify clinical
agency’s estimate of the burden of the
practices and health systems that have
proposed collection of information; (c)
been successful in achieving high rates
ways to enhance the quality, utility, and
of hypertension control and to develop
clarity of the information to be
models for dissemination.
collected; (d) ways to minimize the
DATES: Written comments must be
burden of the collection of information
received on or before July 5, 2016.
on respondents, including through the
ADDRESSES: You may submit comments,
use of automated collection techniques
identified by Docket No. CDC–2016–
or other forms of information
0042 by any of the following methods:
technology; and (e) estimates of capital
Federal eRulemaking Portal:
or start-up costs and costs of operation,
Regulation.gov. Follow the instructions
maintenance, and purchase of services
for submitting comments.
to provide information. Burden means
Mail: Leroy A. Richardson,
the total time, effort, or financial
Information Collection Review Office,
resources expended by persons to
Centers for Disease Control and
generate, maintain, retain, disclose or
Prevention, 1600 Clifton Road NE., MS– provide information to or for a Federal
D74, Atlanta, Georgia 30329.
agency. This includes the time needed
Instructions: All submissions received to review instructions; to develop,
must include the agency name and
acquire, install and utilize technology
Docket Number. All relevant comments
and systems for the purpose of
received will be posted without change
collecting, validating and verifying
to Regulations.gov, including any
information, processing and
personal information provided. For
maintaining information, and disclosing
access to the docket to read background and providing information; to train
documents or comments received, go to personnel and to be able to respond to
Regulations.gov.
a collection of information, to search
Please note: All public comment should be data sources, to complete and review
submitted through the Federal eRulemaking
the collection of information; and to
portal (Regulations.gov) or by U.S. mail to the transmit or otherwise disclose the
address listed above.
information.
FOR FURTHER INFORMATION CONTACT: To
Proposed Project
request more information on the
Million Hearts® Hypertension Control
proposed project or to obtain a copy of
the information collection plan and
Challenge (OMB No. 0920–0976, exp. 7/
instruments, contact the Information
31/2016)—Reinstatement with Change—
Collection Review Office, Centers for
National Center for Chronic Disease
Disease Control and Prevention, 1600
Prevention and Health Promotion

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

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Federal Register / Vol. 81, No. 87 / Thursday, May 5, 2016 / Notices
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®
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® 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 semistructured 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 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
Number of
respondents

Number of
responses per
respondent

Total burden
(in hrs.)

Form name

Physicians (Single or Group Practices)

500

1

.5

250

Finalists ................................................
Selected Champion .............................

Million Hearts® Hypertension Control
Champion Nomination form.
Data Verification Form ........................
Semi-structured Interview ....................

40
40

1
1

1
2

40
80

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.
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Average
burden per
response
(in hrs.)

Type of respondent

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