83 FR 63890 - Proposed Data Collection Submitted for Public Comment and Recommendations

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

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

Page Range		63890-63891
FR Document		2018-26876

The Centers for Disease Control and Prevention (CDC), as part of its continuing effort to reduce public burden and maximize the utility of government information, invites the general public and other Federal agencies the opportunity to comment on a proposed and/or continuing information collection, as required by the Paperwork Reduction Act of 1995. This notice invites comment on a proposed information collection project titled Million Hearts[supreg] Hypertension Control Challenge, a program designed to identify clinical practices and health systems that have been successful in achieving high rates of hypertension control and to develop models for dissemination of successful strategies to control hypertension.

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

[Federal Register Volume 83, Number 238 (Wednesday, December 12, 2018)]
[Notices]
[Pages 63890-63891]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2018-26876]



[[Page 63890]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

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


Proposed Data Collection Submitted for Public Comment and 
Recommendations

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

ACTION: Notice with comment period.

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

SUMMARY: The Centers for Disease Control and Prevention (CDC), as part 
of its continuing effort to reduce public burden and maximize the 
utility of government information, invites the general public and other 
Federal agencies the opportunity to comment on a proposed and/or 
continuing information collection, as required by the Paperwork 
Reduction Act of 1995. This notice invites comment on a proposed 
information collection project titled Million Hearts[supreg] 
Hypertension Control Challenge, a program designed to identify clinical 
practices and health systems that have been successful in achieving 
high rates of hypertension control and to develop models for 
dissemination of successful strategies to control hypertension.

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

ADDRESSES: You may submit comments, identified by Docket No. CDC-2018-
0112 by any of the following methods:
     Federal eRulemaking Portal: Regulations.gov. Follow the 
instructions for submitting comments.
     Mail: Jeffrey M. Zirger, Information Collection Review 
Office, Centers for Disease Control and Prevention, 1600 Clifton Road, 
NE, MS-D74, Atlanta, Georgia 30329.
    Instructions: All submissions received must include the agency name 
and Docket Number. CDC will post, without change, all relevant comments 
to Regulations.gov.
    Please note: Submit all comments through the Federal eRulemaking 
portal (regulations.gov) or by U.S. mail to the address listed above.

FOR FURTHER INFORMATION CONTACT: To request more information on the 
proposed project or to obtain a copy of the information collection plan 
and instruments, contact Jeffrey M. Zirger, Information Collection 
Review Office, Centers for Disease Control and Prevention, 1600 Clifton 
Road, NE, MS-D74, Atlanta, Georgia 30329; phone: 404-639-7570; Email: 
[email protected].

SUPPLEMENTARY INFORMATION: Under the Paperwork Reduction Act of 1995 
(PRA) (44 U.S.C. 3501-3520), Federal agencies must obtain approval from 
the Office of Management and Budget (OMB) for each collection of 
information they conduct or sponsor. In addition, the PRA also requires 
Federal agencies to provide a 60-day notice in the Federal Register 
concerning each proposed collection of information, including each new 
proposed collection, each proposed extension of existing collection of 
information, and each reinstatement of previously approved information 
collection before submitting the collection to the OMB for approval. To 
comply with this requirement, we are publishing this notice of a 
proposed data collection as described below.
    The OMB is particularly interested in comments that will help:
    1. Evaluate whether the proposed collection of information is 
necessary for the proper performance of the functions of the agency, 
including whether the information will have practical utility;
    2. Evaluate the accuracy of the agency's estimate of the burden of 
the proposed collection of information, including the validity of the 
methodology and assumptions used;
    3. Enhance the quality, utility, and clarity of the information to 
be collected; and
    4. Minimize the burden of the collection of information on those 
who are to respond, including through the use of appropriate automated, 
electronic, mechanical, or other technological collection techniques or 
other forms of information technology, e.g., permitting electronic 
submissions of responses.
    5. Assess information collection costs.

Proposed Project

    Million Hearts[supreg] Hypertension Control Challenge (OMB No. 
0920-0976, exp. 12/31/2019--Revision--National Center for Chronic 
disease Prevention and Health Promotion (NCCDPHP), Centers for Disease 
Control and Prevention (CDC).

Background and Brief Description

    Cardiovascular disease is a leading cause of death for men and 
women in the United States, among the most costly health problems 
facing our nation today, and among the most preventable. Heart disease 
and stroke also contribute significantly to disability. High blood 
pressure, also known as hypertension, is one of the leading causes of 
heart disease and stroke. Currently, about 75 million American adults 
have high blood pressure but only about half (48%) have adequately 
controlled blood pressure. The costs of hypertension are estimated at 
$48.9 billion annually in direct medical costs.
    In September 2011, CDC launched the Million Hearts[supreg] 
initiative to prevent one million heart attacks and strokes by 2017. In 
January 2018, CDC launched Million Hearts[supreg] 2022 to continue to 
prevent one million heart attacks, strokes, and related health 
conditions. In order to achieve this goal, at least 10 million more 
Americans must have their blood pressure under control. Million 
Hearts[supreg] is working to reach this goal through the promotion of 
clinical practices that are effective in increasing blood pressure 
control among patient populations. There is scientific evidence that 
provides general guidance on the types of system-based changes to 
clinical practice that can improve patient blood pressure control, but 
additional information is needed to fully understand implementation 
practices so that they can be shared and promoted.
    In 2013, CDC launched the Million Hearts[supreg] Hypertension 
Control Challenge, authorized by Public Law 111-358, the America 
Creating Opportunities to Meaningfully Promote Excellence in 
Technology, Education and Science Reauthorization Act of 2010 (COMPETES 
Act). The Challenge is designed to help CDC (1) identify clinical 
practices and health systems that have been successful in achieving 
high rates of hypertension control, and (2) develop models for 
dissemination. The Challenge is open to single practice providers, 
group practice providers, and healthcare systems. Providers whose 
hypertensive population achieves exemplary levels of hypertension 
control are recognized as Million Hearts[supreg] Hypertension Control 
Champions.
    Interested clinicians or practices complete a web-based application 
form which collects the minimum amount of data needed to demonstrate 
hypertension control among their adult patients, including: (a) Two 
point-in-time measures of the clinical hypertension control rate for 
the patient population, (b) the size of the clinic population served, 
(c) a brief description of the characteristics of the patient 
population served and geographic location, and (d) a description of the 
sustainable systems and strategies adopted to achieve and maintain 
hypertension control rates. The estimated burden for completing the 
application form is 30 minutes. CDC scientists or contractors review 
each

[[Page 63891]]

application form and rank applications by reported hypertension control 
rate.
    In the second phase of assessment, applicants with the highest 
preliminary scores are asked to participate in a two-hour data 
verification and validation process. The applicant reviews the 
application form with a reviewer, describes how information was 
obtained from the providers', practices', or healthcare systems' 
electronic records, chart reviews, or other sources, and reviews the 
methodology used to calculate the reported hypertension control rate. 
Data verification and validation is conducted to ensure that all 
applicants meet eligibility criteria and assure accuracy of their 
reported hypertension control rate according to a standardized method. 
Applicants must have achieved a hypertension control rate of at least 
80% among their adult patients aged 18-85 years with hypertension.
    Finalists who pass the data verification and validation process and 
background check will be reviewed by a CDC panel of judges to determine 
the Champion status. Several Champions will be asked to participate in 
a one-hour, semi-structured interview and provide detailed information 
about the patient population served, the geographic region served, and 
the strategies employed by the practice or health system to achieve 
exemplary rates of hypertension control, including barriers and 
facilitators for those strategies. Based on the information collected 
for Challenges in 2013 through 2017, CDC recognized a total of 83 
public and private health care practices and systems as Million 
Hearts[supreg] Hypertension Control Champions. The Champions are 
announced roughly annually, approximately six months after the 
Challenge application period ends. The current OMB approval for 
information collection expires December 31, 2019.
    CDC plans to continue the Million Hearts[supreg] Hypertension 
Control Challenge through 2022 with revisions. The 2020 Challenge is 
planned to launch in February 2020, coinciding with American Heart 
Month. The application period will be open for approximately 45-60 
days, with recognition of the 2020 Champions in the fall of 2020. A 
similar calendar year schedule is planned for 2021 and 2022. Revision 
for 2020, 2021, and 2022 includes a reduction in the estimated number 
of respondents. During the period of this Renewal request, on an annual 
basis, CDC estimates that information will be collected from up to 200 
applicants using the application form, at most 40 data verifications, 
and at most 35 semi-structured interviews. There is an overall 
reduction in estimated annualized burden hours.
    The overall goal of the Million Hearts[supreg] initiative is to 
prevent one million heart attacks and strokes, and controlling 
hypertension is one focus of the initiative. CDC will use the 
information collected through the Million Hearts[supreg] Hypertension 
Control Challenge to increase widespread attention to hypertension at 
the clinical practice level, improve understanding of successful and 
sustainable implementation strategies at the practice or health system 
level, bring visibility to organizations that invest in hypertension 
control, and motivate individual practices to strengthen their 
hypertension control efforts. Information collected through the
    Million Hearts[supreg] Hypertension Control Challenge will link 
success in clinical outcomes of hypertension control with information 
about strategies that can be used to achieve similar favorable outcomes 
so that the strategies can be replicated by other providers and health 
care systems.
    OMB approval for a revision is requested for three years. CDC 
estimates that up to 200 applicants will submit an application covered 
by this information collection each year. It is estimated that 
information collection activities will total 215 burden hours per year. 
This represents a decrease in the estimated annualized burden hours 
from 370 hours to 215 hours. There is no cost to respondents other than 
their time.

                                        Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
                                                                     Number of    Average burden
      Type of respondents           Form name        Number of     responses per   per response    Total burden
                                                    respondents     respondent      (in hours)      (in hours)
----------------------------------------------------------------------------------------------------------------
Physicians, Practices, and      Million                      200               1           30/60             100
 healthcare systems.             Hearts[supreg]
                                 Hypertension
                                 Control
                                 Champion
                                 Application
                                 form.
Finalists.....................  Data                          40               1               2              80
                                 Verification
                                 Form.
Champions.....................  Semi-structured               35               1               1              35
                                 interview guide.
                                                 ---------------------------------------------------------------
    Total.....................  ................  ..............  ..............  ..............             215
----------------------------------------------------------------------------------------------------------------


Jeffrey M. Zirger,
Acting Lead, Information Collection Review Office, Office of Scientific 
Integrity, Office of Science, Centers for Disease Control and 
Prevention.
[FR Doc. 2018-26876 Filed 12-11-18; 8:45 am]
 BILLING CODE 4163-18-P

63890 Federal Register / Vol. 83, No. 238 / Wednesday, December 12, 2018 / Notices

DEPARTMENT OF HEALTH AND D74, Atlanta, Georgia 30329; phone: million American adults have high
HUMAN SERVICES 404–639–7570; Email: omb@cdc.gov. blood pressure but only about half
SUPPLEMENTARY INFORMATION: Under the (48%) have adequately controlled blood
Centers for Disease Control and Paperwork Reduction Act of 1995 (PRA) pressure. The costs of hypertension are
Prevention (44 U.S.C. 3501–3520), Federal agencies estimated at $48.9 billion annually in
[60Day–19–0976; Docket No. CDC–2018– must obtain approval from the Office of direct medical costs.
0112] Management and Budget (OMB) for each In September 2011, CDC launched the
collection of information they conduct Million Hearts® initiative to prevent one
Proposed Data Collection Submitted or sponsor. In addition, the PRA also million heart attacks and strokes by
for Public Comment and requires Federal agencies to provide a 2017. In January 2018, CDC launched
Recommendations 60-day notice in the Federal Register Million Hearts® 2022 to continue to
concerning each proposed collection of prevent one million heart attacks,
AGENCY: Centers for Disease Control and strokes, and related health conditions.
information, including each new
Prevention (CDC), Department of Health In order to achieve this goal, at least 10
proposed collection, each proposed
and Human Services (HHS). million more Americans must have their
extension of existing collection of
ACTION: Notice with comment period. information, and each reinstatement of blood pressure under control. Million
previously approved information Hearts® is working to reach this goal
SUMMARY: The Centers for Disease through the promotion of clinical
Control and Prevention (CDC), as part of collection before submitting the
collection to the OMB for approval. To practices that are effective in increasing
its continuing effort to reduce public blood pressure control among patient
burden and maximize the utility of comply with this requirement, we are
publishing this notice of a proposed populations. There is scientific evidence
government information, invites the that provides general guidance on the
general public and other Federal data collection as described below.
The OMB is particularly interested in types of system-based changes to
agencies the opportunity to comment on clinical practice that can improve
comments that will help:
a proposed and/or continuing 1. Evaluate whether the proposed patient blood pressure control, but
information collection, as required by collection of information is necessary additional information is needed to
the Paperwork Reduction Act of 1995. for the proper performance of the fully understand implementation
This notice invites comment on a functions of the agency, including practices so that they can be shared and
proposed information collection project whether the information will have promoted.
titled Million Hearts® Hypertension practical utility; In 2013, CDC launched the Million
Control Challenge, a program designed 2. Evaluate the accuracy of the Hearts® Hypertension Control
to identify clinical practices and health agency’s estimate of the burden of the Challenge, authorized by Public Law
systems that have been successful in proposed collection of information, 111–358, the America Creating
achieving high rates of hypertension including the validity of the Opportunities to Meaningfully Promote
control and to develop models for methodology and assumptions used; Excellence in Technology, Education
dissemination of successful strategies to 3. Enhance the quality, utility, and and Science Reauthorization Act of
control hypertension. clarity of the information to be 2010 (COMPETES Act). The Challenge
DATES: CDC must receive written collected; and is designed to help CDC (1) identify
comments on or before February 11, 4. Minimize the burden of the clinical practices and health systems
2019. collection of information on those who that have been successful in achieving
are to respond, including through the high rates of hypertension control, and
ADDRESSES: You may submit comments, (2) develop models for dissemination.
identified by Docket No. CDC–2018– use of appropriate automated,
electronic, mechanical, or other The Challenge is open to single practice
0112 by any of the following methods: providers, group practice providers, and
• Federal eRulemaking Portal: technological collection techniques or
other forms of information technology, healthcare systems. Providers whose
Regulations.gov. Follow the instructions hypertensive population achieves
for submitting comments. e.g., permitting electronic submissions
of responses. exemplary levels of hypertension
• Mail: Jeffrey M. Zirger, Information control are recognized as Million
Collection Review Office, Centers for 5. Assess information collection costs.
Hearts® Hypertension Control
Disease Control and Prevention, 1600 Proposed Project Champions.
Clifton Road, NE, MS–D74, Atlanta, Million Hearts® Hypertension Control Interested clinicians or practices
Georgia 30329. Challenge (OMB No. 0920–0976, exp. complete a web-based application form
Instructions: All submissions received 12/31/2019—Revision—National Center which collects the minimum amount of
must include the agency name and for Chronic disease Prevention and data needed to demonstrate
Docket Number. CDC will post, without Health Promotion (NCCDPHP), Centers hypertension control among their adult
change, all relevant comments to for Disease Control and Prevention patients, including: (a) Two point-in-
Regulations.gov. (CDC). time measures of the clinical
Please note: Submit all comments hypertension control rate for the patient
through the Federal eRulemaking portal Background and Brief Description population, (b) the size of the clinic
(regulations.gov) or by U.S. mail to the Cardiovascular disease is a leading population served, (c) a brief
address listed above. cause of death for men and women in description of the characteristics of the
FOR FURTHER INFORMATION CONTACT: To the United States, among the most patient population served and
amozie on DSK3GDR082PROD with NOTICES1

request more information on the costly health problems facing our nation geographic location, and (d) a
proposed project or to obtain a copy of today, and among the most preventable. description of the sustainable systems
the information collection plan and Heart disease and stroke also contribute and strategies adopted to achieve and
instruments, contact Jeffrey M. Zirger, significantly to disability. High blood maintain hypertension control rates.
Information Collection Review Office, pressure, also known as hypertension, is The estimated burden for completing
Centers for Disease Control and one of the leading causes of heart the application form is 30 minutes. CDC
Prevention, 1600 Clifton Road, NE, MS– disease and stroke. Currently, about 75 scientists or contractors review each

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Document Created: 2018-12-12 01:39:47
Document Modified: 2018-12-12 01:39:47

Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Notices
Action		Notice with comment period.
Dates		CDC must receive written comments on or before February 11, 2019.
Contact		To request more information on the proposed project or to obtain a copy of the information collection plan and instruments, contact Jeffrey M. Zirger, Information Collection Review Office, Centers for Disease Control and Prevention, 1600 Clifton Road, NE, MS-D74, Atlanta, Georgia 30329; phone: 404-639-7570; Email: [email protected]
FR Citation		83 FR 63890

83 FR 63890 - Proposed Data Collection Submitted for Public Comment and Recommendations

DEPARTMENT OF HEALTH AND HUMAN SERVICESCenters for Disease Control and Prevention

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

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