Notice2025-10904
Proposed Data Collection Submitted for Public Comment and Recommendations
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
June 16, 2025
Issuing agencies
Health and Human Services DepartmentCenters for Disease Control and Prevention
Abstract
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 continuing information collection, as required by the Paperwork Reduction Act of 1995. This notice invites comment on a proposed information collection project titled the Million Hearts[supreg] Hypertension Control Challenge. This program is a national initiative to prevent one million heart attacks and strokes by 2027.
Full Text
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<title>Federal Register, Volume 90 Issue 114 (Monday, June 16, 2025)</title>
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[Federal Register Volume 90, Number 114 (Monday, June 16, 2025)]
[Notices]
[Pages 25276-25278]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2025-10904]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[60Day-25-0976; Docket No. CDC-2025-0020]
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 continuing information
collection, as required by the Paperwork Reduction Act of 1995. This
notice invites comment on a proposed information collection project
titled the Million Hearts[supreg] Hypertension Control Challenge. This
program is a national initiative to prevent one million heart attacks
and strokes by 2027.
DATES: CDC must receive written comments on or before August 15, 2025.
ADDRESSES: You may submit comments, identified by Docket No. CDC-2025-
0020 by any of the following methods:
<bullet> Federal eRulemaking Portal: <a href="http://www.regulations.gov">www.regulations.gov</a>. Follow
the instructions for submitting comments.
<bullet> Mail: Jeffrey M. Zirger, Information Collection Review
Office, Centers for Disease Control and Prevention, 1600 Clifton Road
NE, MS H21-8, Atlanta, Georgia 30329.
Instructions: All submissions received must include the agency name
and Docket Number. CDC will post, without change, all relevant comments
to <a href="http://www.regulations.gov">www.regulations.gov</a>.
Please note: Submit all comments through the Federal eRulemaking
portal (<a href="http://www.regulations.gov">www.regulations.gov</a>) 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 H21-8, Atlanta, Georgia 30329; Telephone: 404-639-7118;
Email: <a href="/cdn-cgi/l/email-protection#2a4547486a494e49044d455c"><span class="__cf_email__" data-cfemail="4c23212e0c2f282f622b233a">[email protected]</span></a>.
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;
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; and
5. Assess information collection costs.
Proposed Project
Million Hearts[supreg] Hypertension Control Challenge (OMB Control
No. 0920-0976, Exp. 3/31/2026)--Revision--National Center for Chronic
Disease Prevention and Health Promotion (NCCDPHP), Centers for Disease
Control and Prevention (CDC).
Background and Brief Description
Million Hearts[supreg] is a national initiative to prevent one
million heart attacks and strokes by 2027. To prevent one million
cardiovascular events (e.g., heart attacks and strokes), people need to
decrease smoking, sodium consumption and physical inactivity by 20%;
improve performance on quality-of-care measures for appropriate aspirin
use, blood pressure control, cholesterol management, and smoking
cessation to 80%; and improve outcomes for priority populations
disproportionately burdened by cardiovascular disease. Over the last
nine years, we have seen tremendous progress by providers and health
care systems that focus on improving their performance in controlling
patients' blood pressure. Getting to 80% blood pressure control
(defined as <140/<90 mm Hg) would mean that 10 million more Americans
with hypertension would have their blood pressure under control, and be
at substantially lower risk for strokes, heart attacks, kidney failure,
and other related cardiovascular events. For more information about the
initiative, visit <a href="https://millionhearts.hhs.gov/">https://millionhearts.hhs.gov/</a>. Million
Hearts[supreg] is a registered trademark of the Department of Health
and Human Services (HHS).
The challenge is an important way to call attention to the need for
improved hypertension control, provides a powerful motivation and
target for clinicians, and will improve understanding of successful
implementation strategies at the health system level. It will identify
clinicians, clinical practices, and health systems that have
exceptional rates of hypertension control and recognize them as Million
Hearts[supreg] Hypertension Control Champions. To support improved
quality of care delivered to patients with hypertension, Million
Hearts[supreg] will document the systems, strategies, processes, and
staffing that contribute to the exceptional blood pressure control
rates achieved by Champions.
The challenge is 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). Applicants for the Million Hearts[supreg] Hypertension Control
Challenge will be asked to provide two hypertension control rates for
the practice's or health system's hypertensive population: a current
rate for the most recent 12-month reporting period (e.g., 1/1/2024-12/
31/2024) and a previous rate for the 12-month period immediately
preceding the most recent reporting period (e.g., 1/1/2023-12/31/2023).
Applicants will also be asked to provide the prevalence of hypertension
in their population (more details provided below), describe some
population characteristics (such as urban/rural location, percent
minority, % enrolled in Medicaid, % with no
[[Page 25277]]
health insurance, and % whose primary language is not English) and
strategies used by the practice or health system that support
improvements in blood pressure control. A copy of the application form
will be available on the Challenge website for the duration of the
Challenge.
To be eligible for recognition as a Million Hearts[supreg]
Hypertension Control Champion under this challenge, an individual or
entity
(1) Shall have completed the application form in its entirety to
participate in the competition under the rules developed by HHS/CDC;
(2) Shall have complied with all eligibility requirements and
satisfy the requirements in one of the following subparts:
a. Be a U.S. licensed clinician (i.e., MD, DO, nurse practitioner,
or physician assistant), practicing in any U.S. setting, who provides
ongoing care for adult patients with hypertension. The individual must
be a citizen or permanent resident of the U.S.;
b. Be a U.S. incorporated clinical practice, defined as any
practice with two or more U.S. licensed clinicians who by formal
arrangement share responsibility for a common panel of patients,
practice at the same physical location or street address, and provide
continuing medical care for adult patients with hypertension;
c. Be a health system, incorporated in and maintaining a primary
place of business in the U.S., that provides continuing medical care
for adult patients with hypertension. We encourage large health systems
(those that are comprised of a large number of geographically dispersed
clinics and/or have multiple hospital locations) to consider having one
or a few of the highest performing clinics or regional affiliates apply
individually instead of the health system applying as a whole;
(3) Must treat all adult patients with hypertension in the
practice, not a selected subgroup of patients;
(4) Must have a data management system (electronic or paper) that
allows HHS/CDC or their contractor to verify data submitted;
(5) Must treat a minimum of 500 adult patients annually and have a
hypertension control rate (blood pressure <140 mm Hg systolic and <90
mm Hg diastolic) of at least 80%;
(6) May not be a Federal entity or Federal employee acting within
the scope of their employment;
(7) An HHS employee must not work on their application(s) during
assigned duty hours;
(8) Shall not be an employee of or contractor at CDC;
(9) Must agree to participate in a data validation process to be
conducted by a reputable independent contractor. Data will be kept
confidential by the contractor to the extent applicable law allows and
will be shared with the CDC, in aggregate form only (e.g., the
hypertension control rate for the practice not individual patients'
hypertension values);
(10) Must agree to sign, without revisions, a Business Associate
Agreement with the contractor conducting the data validation;
(11) Must have a written policy in place about conducting periodic
background checks on all providers and taking appropriate action based
on the results of the check. CDC's contractor may also request to
review the policy and any supporting information deemed necessary. In
addition, a health system background check will be conducted by CDC or
a CDC contractor that includes a search for The Joint Commission
sanctions and current investigations for serious institutional
misconduct (e.g., attorney general investigation). Eligibility status,
based upon the above-referenced written policy, appropriate action, and
background check, will be determined at the discretion of the CDC
consistent with CDC's public health mission;
(12) Must agree to be recognized if selected and agree to
participate in an interview to develop a success story that describes
the systems and processes that support hypertension control among
patients. Champions will be recognized on the Million Hearts[supreg]
website. Strategies used by Champions that support hypertension control
may be written into a success story, placed on the Million
Hearts[supreg] website, used in press releases, publications, and
attributed to Champions.
In addition to meeting the requirements listed in parts 1-12 above,
to be eligible for recognition in the challenge, an individual or
entity also must comply with the conditions or requirements set forth
in each of the following paragraphs in this section.
Federal funds may not be used to develop COMPETES Act challenge
applications or to fund efforts in support of a COMPETES Act challenge.
Individual applicants and individuals in a group practice must be
free from convictions for or pending investigations of criminal and
health care fraud offenses such as felony health care fraud, patient
abuse or neglect; felony convictions for other health care-related
fraud, theft, or other financial misconduct; and felony convictions
relating to unlawful manufacture, distribution, prescribing, or
dispensing of controlled substances as verified through the Office of
the Inspector General List of Excluded Individuals and Organizations at
<a href="http://oig.hhs.gov/exclusions/background.asp">http://oig.hhs.gov/exclusions/background.asp</a>.
Individual applicants must be free from recent serious sanctions,
such as those for misuse or mis-prescribing of prescription medications
in the past 20 years. Eligibility status of individual applicants with
serious sanctions will be determined at the discretion of CDC. CDC or
CDC's contractor may perform background checks on individual clinicians
and medical practices.
Champions previously recognized through any of the previous Million
Hearts[supreg] Hypertension Control Challenges retain their designation
as a ``Champion'' and are not eligible to be named a Champion in a new
year of challenge.
An individual or organization shall not be disqualified from the
Million Hearts[supreg] Hypertension Control Challenge for utilizing
Federal facilities or consulting with Federal employees during a
competition so long as the facilities and Federal employees are made
available to all individuals and organizations participating in the
competition on an equal basis.
By participating in this challenge, an individual or organization
agrees to assume any and all risks related to participating in the
challenge. Individuals or organizations also agree to waive claims
against the Federal Government and its related entities, except in the
case of willful misconduct, when participating in the challenge,
including claims for injury; death; damage; or loss of property, money,
or profits, and including those risks caused by negligence or other
causes.
By participating in this challenge, individuals and organizations
agree to protect the Federal Government against third party claims for
damages arising from or related to challenge activities.
Individuals or organizations are not required to hold liability
insurance related to participation in this challenge.
No cash prize will be awarded. Champions will receive national
recognition.
To participate and submit an application, interested parties should
go to <a href="https://millionhearts.hhs.gov">https://millionhearts.hhs.gov</a> or <a href="https://www.challenge.gov">https://www.challenge.gov</a>. On
this site, applicants will find the application form and the rules and
guidelines for participating. Information required of the applicants on
the application form includes:
<bullet> The size of the applicant's adult primary care patient
population, a summary of known patient
[[Page 25278]]
demographics (e.g., age distribution), and any noteworthy patient
population characteristics (such as urban/rural location, percent
minority, percent enrolled in Medicaid, percent with no health
insurance, and percent whose primary language is not English).
<bullet> The number of the applicant's adult primary care patients,
ages 18-85, who were seen during the measurement year and had a
hypertension diagnosis (i.e., hypertension prevalence).
<bullet> The applicant's current hypertension control rate for
their hypertensive population ages 18-85 during the measurement year is
required. In determining the hypertension control rate for the Million
Hearts[supreg] Hypertension Control Challenge, CDC defines
``hypertension control'' as a blood pressure reading <140 mmHg systolic
and <90 mmHg diastolic among patients ages 18-85 with a diagnosis of
hypertension.
<bullet> The hypertension control rate should be for the provider's
or health system's entire adult hypertensive patient population ages
18-85, and not limited to a sample. The provider's or health system's
hypertensive population ages 18-85 should include only patients in
primary care or in cardiology care in the case of a cardiology clinic.
Patients seen only in dental care or behavioral health care should not
be included. Examples of ineligible data submissions include
hypertension control rates that are limited to treatment cohorts from
research studies or pilot studies, patients limited to a specific age
range (such as 18-35 only), or patients enrolled in limited scale
quality improvement projects.
<bullet> Completion of a checklist of sustainable clinic systems or
processes that support hypertension control. These may include provider
or patient incentives, dashboards, staffing characteristics, electronic
record keeping systems, reminder or alert systems, clinician reporting,
service modifications, etc.
The estimated burden for completing the application form is 30
minutes. Up to 35 of the highest scoring clinical practices or health
systems will be recognized as Million Hearts[supreg] Hypertension
Control Champions. The application will be scored based on two
hypertension control rates: one for your most recent 12-month reporting
period ending not earlier than December 31, of the previous calendar
year, and consistency with a previous rate for the 12-month period
beginning 1 year before the current reporting period.
Phase 1 includes verification of the hypertension prevalence and
blood pressure control rate data submitted and a background check. For
applicants whose Phase 1 data is verified as accurate and who pass the
background check without concerns, phase 2 consists of a medical chart
review. The medical chart review will verify the diagnosis of
hypertension during the reporting year as well as blood pressure being
controlled to <140 mmHg systolic and <90 mmHg diastolic. The estimated
time for the data verification and validation is two hours.
A CDC-sponsored panel of three to five experts consisting of CDC
staff will review the applications that pass phase 2 to select
Champions. Final selection of Champions will consider all the
information from the application form, the background check, data
verification and medical chart validation, and final verified
hypertension control rate. In the event of tied scores based on the
hypertension control rate at any point in the selection process,
geographic location may be considered to ensure a broad distribution of
champions. Selected Champions will be notified by phone or email.
Some Champions may participate in a post-challenge telephone
interview. The interview will include questions about the strategies
employed by the individual practice or organization to achieve high
rates of hypertension control, including barriers and facilitators for
those strategies. The interview will focus on systems and processes and
should not require preparation time by the Champion. The estimated time
for the interview is one hour, which includes time to review the
interview protocol with the interviewer, respond to the interview
questions, and review a summary about the Champion's practices. The
summary may be written as a success story and will be posted on the
Million Hearts website.
CDC requests OMB approval for an estimated 215 annual burden hours.
There is no cost to respondents other than their time to participate.
Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
Average
Number of Number of burden per Total burden
Type of respondents Form name respondents responses per response (in hours
respondent hours)
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Physician, practices and Million 200 1 30/60 100
healthcare systems. Hearts[supreg]
Hypertension
Control
Champion
Application
Form.
Finalists..................... Million 40 1 2 80
Hearts[supreg]
Hypertension
Control
Champion Data
Verification
Form.
Champions..................... Interview Guide: 35 1 1 35
Million
Hearts[supreg]
Hypertension
Control
Champion.
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Total..................... ................ .............. .............. .............. 215
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Jeffrey M. Zirger,
Lead, Information Collection Review Office, Office of Public Health
Ethics and Regulations, Office of Science, Centers for Disease Control
and Prevention.
[FR Doc. 2025-10904 Filed 6-13-25; 8:45 am]
BILLING CODE 4163-18-P
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