82_FR_16659 82 FR 16595 - Announcement of Requirements and Registration for Million Hearts® Hypertension Control Challenge

82 FR 16595 - Announcement of Requirements and Registration for Million Hearts® Hypertension Control Challenge

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention (CDC)

Federal Register Volume 82, Issue 64 (April 5, 2017)

Page Range16595-16597
FR Document2017-06670

The Centers for Disease Control and Prevention (CDC) located within the Department of Health and Human Services (HHS) announces the launch of the Million Hearts[supreg] Hypertension Control Challenge. Million Hearts[supreg] is a national initiative to prevent one million heart attacks and strokes by 2022. Achieving this goal means 10 million more Americans must have their blood pressure under control. Million Hearts[supreg] is working to control high blood pressure through clinical approaches, such as using health information technology to its fullest potential and integrating team-based approaches to health care, and community approaches, such as strengthening tobacco control and promoting physical activity. For more information about the initiative, visit https://millionhearts.hhs.gov/. To support improved blood pressure control, HHS/CDC is announcing the 2017 Million Hearts[supreg] Hypertension Control Challenge. The challenge will improve understanding of successful implementation strategies at the health system level by motivating clinical practices and health systems to strengthen their hypertension control efforts. 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.

Federal Register, Volume 82 Issue 64 (Wednesday, April 5, 2017)
[Federal Register Volume 82, Number 64 (Wednesday, April 5, 2017)]
[Notices]
[Pages 16595-16597]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2017-06670]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention (CDC)


Announcement of Requirements and Registration for Million 
Hearts[supreg] Hypertension Control Challenge

AGENCY: Centers for Disease Control and Prevention (CDC), Department of 
Health and Human Services (HHS).

ACTION: Notice.

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

SUMMARY: The Centers for Disease Control and Prevention (CDC) located 
within the Department of Health and Human Services (HHS) announces the 
launch of the Million Hearts[supreg] Hypertension Control Challenge.
    Million Hearts[supreg] is a national initiative to prevent one 
million heart attacks and strokes by 2022. Achieving this goal means 10 
million more Americans must have their blood pressure under control. 
Million Hearts[supreg] is working to control high blood pressure 
through clinical approaches, such as using health information 
technology to its fullest potential and integrating team-based 
approaches to health care, and community approaches, such as 
strengthening tobacco control and promoting physical activity. For more 
information about the initiative, visit https://millionhearts.hhs.gov/.
    To support improved blood pressure control, HHS/CDC is announcing 
the 2017 Million Hearts[supreg] Hypertension Control Challenge. The 
challenge will improve understanding of successful implementation 
strategies at the health system level by motivating clinical practices 
and health systems to strengthen their hypertension control efforts. 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.

DATES: The Challenge will run from April 7, 2017 through June 2, 2017.

FOR FURTHER INFORMATION CONTACT: Division for Heart Disease and Stroke 
Prevention, National Center for Chronic Disease Prevention and Health 
Promotion, Centers for Disease Control and Prevention, 4770 Buford Hwy 
NE., Mailstop F-73, Chamblee, GA 30341, Telephone: 770-488-2424, Email: 
millionh[email protected]; subject line of email: Million Hearts 
Hypertension Control Challenge; Attention: Mary George.

SUPPLEMENTARY INFORMATION:
    Award Approving Official: Anne Schuchat, MD, Acting Director, 
Centers for Disease Control and Prevention, and Administrator, Agency 
for Toxic Substances and Disease Registry
    Subject of Challenge Competition: 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).
    Entrants to the Million Hearts 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 your 
most recent 12-month reporting period and a previous rate for a 12 
month period 1 to 2 years before the current rate. Entrants will also 
be asked to provide the prevalence of hypertension in their population, 
describe some population characteristics that might present significant 
challenges and barriers in controlling hypertension. Entrants with 
patients presenting with these challenges, as well entrants with 
systems and processes in place that support hypertension control and 
are likely to endure, such as electronic reminder systems or team based 
care, will be taken into consideration in selection.
    Nominations will be scored and judged separately by size and type 
of nominee in the categories listed below. CDC does not guarantee that 
a specific proportion of Champions will be selected from each category.
     Small individual providers or practices (500-49,999 
covered lives)
     Large providers or practices (50,000 or more covered 
lives)
     Health Systems
    Eligibility Rules for Participating in the Competition:
    To be eligible to be recognized as a Hypertension Champion under 
this challenge, an individual or entity--
    (1) Shall have completed the nomination form in its entirety to 
participate in the competition under the rules developed by HHS/CDC;
    (2) Shall have complied with all the requirements in this section 
and;
    a. Be a U.S. licensed clinician, practicing in any U.S. setting, 
who provides continuing care for adult patients with hypertension. The 
individual must be a citizen or permanent resident of the U.S.
    b. Or 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. Or 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 
seeking care, not a selected subgroup of patients;
    (4) Must have a data management system (electronic or paper) that 
allows HHS/CDC or their contractor to check data submitted;
    (5) Must treat a minimum of 500 adult patients annually and have a 
hypertension control rate of at least 70%;
    (6) May not be a Federal entity or Federal employee acting within 
the scope of their employment;
    (7) Shall not be an HHS employee working on their applications or 
submissions during assigned duty hours;
    (8) Shall not be an employee 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 (i.e., the 
hypertension control rate for the practice not individual hypertension 
values);
    (10) Must agree to sign a Business Associate Agreement with the 
contractor conducting the data validation.
    (11) Must have a written policy in place regarding conducting 
periodic background checks on all providers and

[[Page 16596]]

taking appropriate action based on the results of the check. CDC's 
contractor may also request 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., investigations for professional medical 
misconduct). 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] 
Web site. Strategies used by Champions that support hypertension 
control may be written into a success story, placed on the Million 
Hearts[supreg] Web site, and attributed to Champions.
    Federal grantees may not use Federal funds to develop COMPETES Act 
challenge applications unless consistent with the purpose of their 
grant award and specifically requested to do so due to competition 
design.
    Federal contractors may not use Federal funds from a contract to 
develop COMPETES Act challenge applications or to fund efforts in 
support of a COMPETES Act challenge.
    Individual nominees and individuals in a group practice must be 
free from convictions 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 Entities. http://oig.hhs.gov/exclusions/background.asp.
    Individual nominees must be free from serious sanctions, such as 
those for misuse or mis-prescribing of prescription medications. 
Eligibility status of individual nominees with serious sanctions will 
be determined at the discretion of CDC. CDC's contractor may perform 
background checks on individual clinicians or medical practices.
    Champions previously recognized through the 2013, 2014, and 2015 
Million Hearts Hypertension Control Challenge retain their designation 
as a ``Champion'' and are not eligible to be named a Champion in the 
2017 challenge.
    An individual or entity shall not be deemed ineligible because the 
individual or entity used Federal facilities or consulted with Federal 
employees during a competition if the facilities and employees are made 
available to all individuals and entities 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 or 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 local and 
national recognition.
    Registration Process for Participants:
    To participate, interested parties should go to https://millionhearts.hhs.gov/. On this site, nominees will find the entry form 
and the rules and guidelines for participating. Information required of 
the nominees on the nomination form includes:
     The size of the nominee's adult patient population, a 
summary of known patient demographics (e.g., age distribution), and any 
noteworthy patient population characteristics.
     The number of the nominee's adult patients who were seen 
during the past year and had a hypertension diagnosis (i.e., 
hypertension prevalence).
     The nominee's current hypertension control rate for their 
hypertensive population. In addition, the hypertension control rate 
during the previous year is required. In determining the hypertension 
control rate, CDC defines ``hypertension control'' as a blood pressure 
reading <140 mmHg systolic and <90 mmHg diastolic among patients with a 
diagnosis of hypertension.
    The hypertension control rate should be for the provider's or 
health system's entire adult hypertensive patient population, not 
limited to a sample. 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), or patients enrolled in limited scale quality 
improvement projects.
     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 nomination form is 30 
minutes.
    Amount of the Prize:
    Up to a total of 40 of the highest scoring clinical practices or 
health systems will be recognized as Million Hearts[supreg] 
Hypertension Control Champions.
    Basis upon Which Winner Will Be Selected:
    The nomination will be scored based on hypertension control rate 
(at least 90% of score); and sustainable systems in the practice that 
support hypertension control (up to 5% of score); and patient 
population that is high risk (up to 5% of score).
    Nominees with the highest score will be required to participate in 
a two-phase process to verify their data. Nominees who are non-
compliant or non-responsive with the data requests or timelines will be 
removed from further consideration. Phase 1 includes verification of 
the hypertension prevalence and blood pressure control rate data 
submitted and a background check. For nominees whose Phase 1 data is 
verified as accurate, phase 2 consists of a medical chart review.
    A CDC-sponsored panel of three to five experts consisting of HHS/
CDC staff will review the nominations that pass phase 2 to select 
Champions. Final selection of Champions will take into account all the 
information from the nomination form, the background check, and data 
verification. In the event of tie scores at any point in the selection 
process, geographic location may be taken into account to ensure a 
broad distribution of champions across rural or more populated areas, 
representing potentially underserved populations.
    Some Champions will participate in a post-challenge telephone 
interview. The interview will include questions about the strategies 
employed by the individual or organization to achieve high rates of 
hypertension control, including barriers and facilitators for

[[Page 16597]]

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 two hours, which includes time to review the 
interview protocol with the interviewer, respond to the interview 
questions, and review a summary data about the Champion's practices. 
The summary will be written as a success story and will be posted on 
the Million Hearts[supreg] Web site.
    Additional Information:
    Information received from nominees will be stored in a password 
protected file on a secure server. The challenge Web site may post the 
number of nominations received but will not include confidential or 
proprietary information about individual nominees, as described further 
below. The database of information submitted by nominees will not be 
posted on the Web site. Information collected from nominees will 
include general details, such as the business name, address, and 
contact information of the nominee. This type of information is 
generally publicly available. The nomination will collect and store 
only aggregate clinical data through the nomination process; no 
individual identifiable patient data will be collected or stored. 
Confidential or propriety data, clearly marked as such, will be secured 
to the full extent allowable by law.
    Information for selected Champions, such as the provider, practice, 
or health system's name, location, hypertension control rate, and 
clinic practices that support hypertension control will be shared 
through press releases, the challenge Web site, and Million 
Hearts[supreg] and HHS/CDC resources.
    Summary data on the types of systems and processes that all 
nominees use to control hypertension may be shared in documents or 
other communication products that describe generally used practices for 
successful hypertension control. HHS/CDC will use the summary data only 
as described.
    Compliance with Rules and Contacting Contest Winners:
    Finalists and the Champions must comply with all terms and 
conditions of these Official Rules, and winning is contingent upon 
fulfilling all requirements herein. The initial finalists will be 
notified by email, telephone, or mail after the date of the judging.
    Privacy:
    If Contestants choose to provide HHS/CDC with personal information 
by registering or filling out the submission form through the 
Challenge.gov Web site, that information is used to respond to 
Contestants in matters regarding their submission, announcements of 
entrants, finalists, and winners of the Contest. Information is not 
collected for commercial marketing. Champions are permitted to cite 
that they were selected as Champions for the 2017 Million Hearts 
Hypertension Control Challenge.
    General Conditions:
    HHS/CDC reserves the right to cancel, suspend, and/or modify the 
Challenge, or any part of it, for any reason, at HHS/CDC's sole 
discretion. If the Challenge is cancelled, suspended, and/or modified, 
HHS/CDC will inform the public through the publication of a notice in 
the Federal Register.
    Participation in this Contest constitutes a contestants' full and 
unconditional agreement to abide by the Contest's Official Rules found 
at www.Challenge.gov.

    Authority:  15 U.S.C. 3719.

    Dated: March 30, 2017.
Sandra Cashman,
Executive Secretary, Centers for Disease Control and Prevention.
[FR Doc. 2017-06670 Filed 4-4-17; 8:45 am]
 BILLING CODE 4163-18-P



                                                                                Federal Register / Vol. 82, No. 64 / Wednesday, April 5, 2017 / Notices                                           16595

                                                  Prevention and the Agency for Toxic                     DATES: The Challenge will run from                    participate in the competition under the
                                                  Substances and Disease Registry.                        April 7, 2017 through June 2, 2017.                   rules developed by HHS/CDC;
                                                                                                          FOR FURTHER INFORMATION CONTACT:                         (2) Shall have complied with all the
                                                  Claudette Grant,
                                                                                                          Division for Heart Disease and Stroke                 requirements in this section and;
                                                  Acting Director, Management Analysis and                                                                         a. Be a U.S. licensed clinician,
                                                  Services Office, Centers for Disease Control            Prevention, National Center for Chronic
                                                                                                          Disease Prevention and Health                         practicing in any U.S. setting, who
                                                  and Prevention.
                                                                                                          Promotion, Centers for Disease Control                provides continuing care for adult
                                                  [FR Doc. 2017–06673 Filed 4–4–17; 8:45 am]
                                                                                                          and Prevention, 4770 Buford Hwy NE.,                  patients with hypertension. The
                                                  BILLING CODE 4163–18–P                                                                                        individual must be a citizen or
                                                                                                          Mailstop F–73, Chamblee, GA 30341,
                                                                                                          Telephone: 770–488–2424, Email:                       permanent resident of the U.S.
                                                                                                          millionhearts@cdc.gov; subject line of                   b. Or be a U.S. incorporated clinical
                                                  DEPARTMENT OF HEALTH AND                                                                                      practice, defined as any practice with
                                                  HUMAN SERVICES                                          email: Million Hearts Hypertension
                                                                                                          Control Challenge; Attention: Mary                    two or more U.S. licensed clinicians
                                                  Centers for Disease Control and                         George.                                               who by formal arrangement share
                                                  Prevention (CDC)                                                                                              responsibility for a common panel of
                                                                                                          SUPPLEMENTARY INFORMATION:                            patients, practice at the same physical
                                                                                                             Award Approving Official: Anne                     location or street address, and provide
                                                  Announcement of Requirements and
                                                                                                          Schuchat, MD, Acting Director, Centers                continuing medical care for adult
                                                  Registration for Million Hearts®
                                                                                                          for Disease Control and Prevention, and               patients with hypertension;
                                                  Hypertension Control Challenge
                                                                                                          Administrator, Agency for Toxic                          c. Or be a health system, incorporated
                                                  AGENCY: Centers for Disease Control and                 Substances and Disease Registry                       in and maintaining a primary place of
                                                  Prevention (CDC), Department of Health                     Subject of Challenge Competition:                  business in the U.S. that provides
                                                  and Human Services (HHS).                               The challenge is authorized by Public                 continuing medical care for adult
                                                  ACTION: Notice.                                         Law 111–358, the America Creating                     patients with hypertension. We
                                                                                                          Opportunities to Meaningfully Promote                 encourage large health systems (those
                                                  SUMMARY:    The Centers for Disease                     Excellence in Technology, Education                   that are comprised of a large number of
                                                  Control and Prevention (CDC) located                    and Science Reauthorization Act of                    geographically dispersed clinics and/or
                                                  within the Department of Health and                     2010 (COMPETES Act).                                  have multiple hospital locations) to
                                                  Human Services (HHS) announces the                         Entrants to the Million Hearts                     consider having one or a few of the
                                                  launch of the Million Hearts®                           Hypertension Control Challenge will be                highest performing clinics or regional
                                                  Hypertension Control Challenge.                         asked to provide two hypertension                     affiliates apply individually instead of
                                                     Million Hearts® is a national initiative             control rates for the practice’s or health            the health system applying as a whole;
                                                  to prevent one million heart attacks and                system’s hypertensive population: A                      (3) Must treat all adult patients with
                                                  strokes by 2022. Achieving this goal                    current rate for your most recent 12-                 hypertension in the practice seeking
                                                  means 10 million more Americans must                    month reporting period and a previous                 care, not a selected subgroup of patients;
                                                  have their blood pressure under control.                rate for a 12 month period 1 to 2 years                  (4) Must have a data management
                                                  Million Hearts® is working to control                   before the current rate. Entrants will                system (electronic or paper) that allows
                                                  high blood pressure through clinical                    also be asked to provide the prevalence               HHS/CDC or their contractor to check
                                                  approaches, such as using health                        of hypertension in their population,                  data submitted;
                                                  information technology to its fullest                   describe some population                                 (5) Must treat a minimum of 500 adult
                                                  potential and integrating team-based                    characteristics that might present                    patients annually and have a
                                                  approaches to health care, and                          significant challenges and barriers in                hypertension control rate of at least
                                                  community approaches, such as                           controlling hypertension. Entrants with               70%;
                                                  strengthening tobacco control and                       patients presenting with these                           (6) May not be a Federal entity or
                                                  promoting physical activity. For more                   challenges, as well entrants with                     Federal employee acting within the
                                                  information about the initiative, visit                 systems and processes in place that                   scope of their employment;
                                                  https://millionhearts.hhs.gov/.                         support hypertension control and are                     (7) Shall not be an HHS employee
                                                     To support improved blood pressure                   likely to endure, such as electronic                  working on their applications or
                                                  control, HHS/CDC is announcing the                      reminder systems or team based care,                  submissions during assigned duty
                                                  2017 Million Hearts® Hypertension                       will be taken into consideration in                   hours;
                                                  Control Challenge. The challenge will                   selection.                                               (8) Shall not be an employee or
                                                  improve understanding of successful                        Nominations will be scored and                     contractor at CDC;
                                                  implementation strategies at the health                 judged separately by size and type of                    (9) Must agree to participate in a data
                                                  system level by motivating clinical                     nominee in the categories listed below.               validation process to be conducted by a
                                                  practices and health systems to                         CDC does not guarantee that a specific                reputable independent contractor. Data
                                                  strengthen their hypertension control                   proportion of Champions will be                       will be kept confidential by the
                                                  efforts. It will identify clinicians,                   selected from each category.                          contractor to the extent applicable law
                                                  clinical practices, and health systems                     • Small individual providers or                    allows and will be shared with the CDC,
                                                  that have exceptional rates of                          practices (500–49,999 covered lives)                  in aggregate form only (i.e., the
                                                  hypertension control and recognize                         • Large providers or practices (50,000             hypertension control rate for the
                                                  them as Million Hearts® Hypertension                    or more covered lives)                                practice not individual hypertension
                                                  Control Champions. To support                              • Health Systems
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                                                                                                                                                                values);
                                                  improved quality of care delivered to                      Eligibility Rules for Participating in                (10) Must agree to sign a Business
                                                  patients with hypertension, Million                     the Competition:                                      Associate Agreement with the
                                                  Hearts® will document the systems,                         To be eligible to be recognized as a               contractor conducting the data
                                                  strategies, processes, and staffing that                Hypertension Champion under this                      validation.
                                                  contribute to the exceptional blood                     challenge, an individual or entity—                      (11) Must have a written policy in
                                                  pressure control rates achieved by                         (1) Shall have completed the                       place regarding conducting periodic
                                                  Champions.                                              nomination form in its entirety to                    background checks on all providers and


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                                                  16596                         Federal Register / Vol. 82, No. 64 / Wednesday, April 5, 2017 / Notices

                                                  taking appropriate action based on the                  ‘‘Champion’’ and are not eligible to be               population, not limited to a sample.
                                                  results of the check. CDC’s contractor                  named a Champion in the 2017                          Examples of ineligible data submissions
                                                  may also request the policy and any                     challenge.                                            include hypertension control rates that
                                                  supporting information deemed                              An individual or entity shall not be               are limited to treatment cohorts from
                                                  necessary. In addition, a health system                 deemed ineligible because the                         research studies or pilot studies,
                                                  background check will be conducted by                   individual or entity used Federal                     patients limited to a specific age range
                                                  CDC or a CDC contractor that includes                   facilities or consulted with Federal                  (such as 18–35), or patients enrolled in
                                                  a search for The Joint Commission                       employees during a competition if the                 limited scale quality improvement
                                                  sanctions and current investigations for                facilities and employees are made                     projects.
                                                  serious institutional misconduct (e.g.,                 available to all individuals and entities                • Completion of a checklist of
                                                  investigations for professional medical                 participating in the competition on an                sustainable clinic systems or processes
                                                  misconduct). Eligibility status, based                  equal basis.                                          that support hypertension control.
                                                  upon the above-referenced written                          By participating in this challenge, an             These may include provider or patient
                                                  policy, appropriate action, and                         individual or organization agrees to                  incentives, dashboards, staffing
                                                  background check, will be determined                    assume any and all risks related to                   characteristics, electronic record
                                                  at the discretion of the CDC consistent                 participating in the challenge.                       keeping systems, reminder or alert
                                                  with CDC’s public health mission.                       Individuals or organizations also agree               systems, clinician reporting, service
                                                     (12) Must agree to be recognized if                  to waive claims against the Federal                   modifications, etc.
                                                  selected and agree to participate in an                 Government and its related entities,                     The estimated burden for completing
                                                  interview to develop a success story that               except in the case of willful misconduct,             the nomination form is 30 minutes.
                                                  describes the systems and processes that                when participating in the challenge,                     Amount of the Prize:
                                                  support hypertension control among                      including claims for injury; death;                      Up to a total of 40 of the highest
                                                  patients. Champions will be recognized                  damage; or loss of property, money, or                scoring clinical practices or health
                                                  on the Million Hearts® Web site.                        profits, and including those risks caused             systems will be recognized as Million
                                                  Strategies used by Champions that                       by negligence or other causes.                        Hearts® Hypertension Control
                                                  support hypertension control may be                        By participating in this challenge,                Champions.
                                                  written into a success story, placed on                 individuals or organizations agree to                    Basis upon Which Winner Will Be
                                                  the Million Hearts® Web site, and                       protect the Federal Government against                Selected:
                                                  attributed to Champions.                                third party claims for damages arising                   The nomination will be scored based
                                                     Federal grantees may not use Federal                 from or related to challenge activities.              on hypertension control rate (at least
                                                  funds to develop COMPETES Act                              Individuals or organizations are not               90% of score); and sustainable systems
                                                  challenge applications unless consistent                required to hold liability insurance                  in the practice that support
                                                  with the purpose of their grant award                   related to participation in this                      hypertension control (up to 5% of
                                                  and specifically requested to do so due                 challenge.                                            score); and patient population that is
                                                  to competition design.                                     No cash prize will be awarded.                     high risk (up to 5% of score).
                                                     Federal contractors may not use                      Champions will receive local and                         Nominees with the highest score will
                                                  Federal funds from a contract to develop                national recognition.                                 be required to participate in a two-phase
                                                  COMPETES Act challenge applications                        Registration Process for Participants:             process to verify their data. Nominees
                                                  or to fund efforts in support of a                         To participate, interested parties                 who are non-compliant or non-
                                                  COMPETES Act challenge.                                 should go to https://                                 responsive with the data requests or
                                                     Individual nominees and individuals                  millionhearts.hhs.gov/. On this site,                 timelines will be removed from further
                                                  in a group practice must be free from                   nominees will find the entry form and                 consideration. Phase 1 includes
                                                  convictions or pending investigations of                the rules and guidelines for                          verification of the hypertension
                                                  criminal and health care fraud offenses                 participating. Information required of                prevalence and blood pressure control
                                                  such as felony health care fraud, patient               the nominees on the nomination form                   rate data submitted and a background
                                                  abuse or neglect; felony convictions for                includes:                                             check. For nominees whose Phase 1
                                                  other health care-related fraud, theft, or                 • The size of the nominee’s adult                  data is verified as accurate, phase 2
                                                  other financial misconduct; and felony                  patient population, a summary of                      consists of a medical chart review.
                                                  convictions relating to unlawful                        known patient demographics (e.g., age                    A CDC-sponsored panel of three to
                                                  manufacture, distribution, prescribing,                 distribution), and any noteworthy                     five experts consisting of HHS/CDC staff
                                                  or dispensing of controlled substances                  patient population characteristics.                   will review the nominations that pass
                                                  as verified through the Office of the                      • The number of the nominee’s adult                phase 2 to select Champions. Final
                                                  Inspector General List of Excluded                      patients who were seen during the past                selection of Champions will take into
                                                  Individuals and Entities. http://                       year and had a hypertension diagnosis                 account all the information from the
                                                  oig.hhs.gov/exclusions/background.asp.                  (i.e., hypertension prevalence).                      nomination form, the background check,
                                                     Individual nominees must be free                        • The nominee’s current                            and data verification. In the event of tie
                                                  from serious sanctions, such as those for               hypertension control rate for their                   scores at any point in the selection
                                                  misuse or mis-prescribing of                            hypertensive population. In addition,                 process, geographic location may be
                                                  prescription medications. Eligibility                   the hypertension control rate during the              taken into account to ensure a broad
                                                  status of individual nominees with                      previous year is required. In                         distribution of champions across rural
                                                  serious sanctions will be determined at                 determining the hypertension control                  or more populated areas, representing
jstallworth on DSK7TPTVN1PROD with NOTICES




                                                  the discretion of CDC. CDC’s contractor                 rate, CDC defines ‘‘hypertension                      potentially underserved populations.
                                                  may perform background checks on                        control’’ as a blood pressure reading                    Some Champions will participate in a
                                                  individual clinicians or medical                        <140 mmHg systolic and <90 mmHg                       post-challenge telephone interview. The
                                                  practices.                                              diastolic among patients with a                       interview will include questions about
                                                     Champions previously recognized                      diagnosis of hypertension.                            the strategies employed by the
                                                  through the 2013, 2014, and 2015                           The hypertension control rate should               individual or organization to achieve
                                                  Million Hearts Hypertension Control                     be for the provider’s or health system’s              high rates of hypertension control,
                                                  Challenge retain their designation as a                 entire adult hypertensive patient                     including barriers and facilitators for


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                                                                                Federal Register / Vol. 82, No. 64 / Wednesday, April 5, 2017 / Notices                                          16597

                                                  those strategies. The interview will                    finalists, and winners of the Contest.                electronic or written comments on this
                                                  focus on systems and processes and                      Information is not collected for                      public workshop by April 27, 2017.
                                                  should not require preparation time by                  commercial marketing. Champions are                   Late, untimely filed comments will not
                                                  the Champion. The estimated time for                    permitted to cite that they were selected             be considered. Electronic comments
                                                  the interview is two hours, which                       as Champions for the 2017 Million                     must be submitted on or before April 27,
                                                  includes time to review the interview                   Hearts Hypertension Control Challenge.                2017. The https://www.regulations.gov
                                                  protocol with the interviewer, respond                     General Conditions:                                electronic filing system will accept
                                                  to the interview questions, and review                     HHS/CDC reserves the right to cancel,              comments until midnight Eastern Time
                                                  a summary data about the Champion’s                     suspend, and/or modify the Challenge,                 at the end of April 27, 2017. Comments
                                                  practices. The summary will be written                  or any part of it, for any reason, at HHS/            received by mail/hand delivery/courier
                                                  as a success story and will be posted on                CDC’s sole discretion. If the Challenge is            (for written/paper submissions) will be
                                                  the Million Hearts® Web site.                           cancelled, suspended, and/or modified,                considered timely if they are
                                                     Additional Information:                              HHS/CDC will inform the public                        postmarked or the delivery service
                                                     Information received from nominees                   through the publication of a notice in                acceptance receipt is on or before that
                                                  will be stored in a password protected                  the Federal Register.                                 date. See the SUPPLEMENTARY
                                                  file on a secure server. The challenge                     Participation in this Contest                      INFORMATION section for registration date
                                                  Web site may post the number of                         constitutes a contestants’ full and                   and information. Workshop updates and
                                                  nominations received but will not                       unconditional agreement to abide by the               the workshop agenda will be made
                                                  include confidential or proprietary                     Contest’s Official Rules found at                     available at: http://www.fda.gov/Drugs/
                                                  information about individual nominees,                  www.Challenge.gov.                                    NewsEvents/ucm532070 prior to the
                                                  as described further below. The                                                                               workshop.
                                                                                                            Authority: 15 U.S.C. 3719.
                                                  database of information submitted by
                                                  nominees will not be posted on the Web                    Dated: March 30, 2017.                              ADDRESSES:   The public workshop will
                                                  site. Information collected from                        Sandra Cashman,                                       be held at the Tommy Douglas
                                                  nominees will include general details,                  Executive Secretary, Centers for Disease              Conference Center, 10000 New
                                                  such as the business name, address, and                 Control and Prevention.                               Hampshire Ave., Silver Spring, MD
                                                  contact information of the nominee.                     [FR Doc. 2017–06670 Filed 4–4–17; 8:45 am]            20903. The conference center’s phone
                                                  This type of information is generally                   BILLING CODE 4163–18–P
                                                                                                                                                                number is 240–645–4000.
                                                  publicly available. The nomination will                                                                         You may submit comments as
                                                  collect and store only aggregate clinical                                                                     follows:
                                                  data through the nomination process; no                 DEPARTMENT OF HEALTH AND                              Electronic Submissions
                                                  individual identifiable patient data will               HUMAN SERVICES
                                                  be collected or stored. Confidential or                                                                         Submit electronic comments in the
                                                  propriety data, clearly marked as such,                 Food and Drug Administration                          following way:
                                                  will be secured to the full extent                                                                              • Federal eRulemaking Portal:
                                                                                                          [Docket No. FDA–2017–N–0726]
                                                  allowable by law.                                                                                             https://www.regulations.gov. Follow the
                                                     Information for selected Champions,                  Antibody Mediated Rejection in Kidney                 instructions for submitting comments.
                                                  such as the provider, practice, or health               Transplantation; Public Workshop;                     Comments submitted electronically,
                                                  system’s name, location, hypertension                   Request for Comments                                  including attachments, to https://
                                                  control rate, and clinic practices that                                                                       www.regulations.gov will be posted to
                                                  support hypertension control will be                    AGENCY:    Food and Drug Administration,              the docket unchanged. Because your
                                                  shared through press releases, the                      HHS.                                                  comment will be made public, you are
                                                  challenge Web site, and Million Hearts®                 ACTION: Notice of public workshop;                    solely responsible for ensuring that your
                                                  and HHS/CDC resources.                                  request for comments.                                 comment does not include any
                                                     Summary data on the types of systems                                                                       confidential information that you or a
                                                                                                          SUMMARY:    The Food and Drug                         third party may not wish to be posted,
                                                  and processes that all nominees use to
                                                                                                          Administration (FDA, the Agency, or                   such as medical information, your or
                                                  control hypertension may be shared in
                                                                                                          we) is announcing a public workshop                   anyone else’s Social Security number, or
                                                  documents or other communication
                                                                                                          regarding new developments and                        confidential business information, such
                                                  products that describe generally used
                                                                                                          scientific issues related to antibody                 as a manufacturing process. Please note
                                                  practices for successful hypertension
                                                                                                          mediated rejection (AMR) in kidney                    that if you include your name, contact
                                                  control. HHS/CDC will use the summary
                                                                                                          transplantation. This public workshop                 information, or other information that
                                                  data only as described.
                                                     Compliance with Rules and                            is intended to provide information for                identifies you in the body of your
                                                  Contacting Contest Winners:                             and gain perspective from individuals,                comments, that information will be
                                                     Finalists and the Champions must                     industry, health care professionals,                  posted on https://www.regulations.gov.
                                                  comply with all terms and conditions of                 researchers, public health organizations,               • If you want to submit a comment
                                                  these Official Rules, and winning is                    patients, patient care providers, and                 with confidential information that you
                                                  contingent upon fulfilling all                          other interested persons on various                   do not wish to be made available to the
                                                  requirements herein. The initial finalists              aspects of clinical development of                    public, submit the comment as a
                                                  will be notified by email, telephone, or                medical products for prophylaxis and/or               written/paper submission and in the
                                                  mail after the date of the judging.                     treatment of AMR in kidney transplant                 manner detailed (see ‘‘Written/Paper
                                                                                                          recipients, including clinical trial
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                                                     Privacy:                                                                                                   Submissions’’ and ‘‘Instructions’’).
                                                     If Contestants choose to provide HHS/                design and endpoints. The input from
                                                  CDC with personal information by                        this public workshop will also help in                Written/Paper Submissions
                                                  registering or filling out the submission               developing topics for future discussion.                Submit written/paper submissions as
                                                  form through the Challenge.gov Web                      DATES: The public workshop will be                    follows:
                                                  site, that information is used to respond               held on April 12, 2017, from 8 a.m. to                  • Mail/Hand delivery/Courier (for
                                                  to Contestants in matters regarding their               6 p.m. and April 13, 2017, from 8:30                  written/paper submissions): Division of
                                                  submission, announcements of entrants,                  a.m. to 1:30 p.m. Submit either                       Dockets Management (HFA–305), Food


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Document Created: 2018-02-01 14:47:08
Document Modified: 2018-02-01 14:47:08
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionNotices
ActionNotice.
DatesThe Challenge will run from April 7, 2017 through June 2, 2017.
ContactDivision for Heart Disease and Stroke Prevention, National Center for Chronic Disease Prevention and Health Promotion, Centers for Disease Control and Prevention, 4770 Buford Hwy NE., Mailstop F-73, Chamblee, GA 30341, Telephone: 770-488-2424, Email: [email protected]; subject line of email: Million Hearts Hypertension Control Challenge; Attention: Mary George.
FR Citation82 FR 16595 

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