Federal Register Notice

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Federal Register / Vol. 86, No. 242 / Tuesday, December 21, 2021 / Notices
increasingly reported worldwide and
are associated with increased mortality
and treatment failure. Of particular
concern are resistant A. fumigatus
isolates carrying the TR34/L98H and
TR46/Y121F genetic resistance markers,
which are associated with
environmental triazole fungicide use
rather than previous patient exposure to
antifungals. Infections with these
triazole-resistant strains have become
common among patients with A.
fumigatus infections in Europe, Asia,
and South America, and have been
characterized epidemiologically.
However, U.S. reports of isolates
carrying TR34/L98H or TR46/Y121F
markers are limited, and detailed
epidemiologic data are critical to inform
public health response.

departments and contains an optional
supplement at the end involving a brief
interview (including data on
occupational and environmental
exposures) of a patient or their
representative. The findings would be
used to describe the risk factors, clinical
features, and outcomes for patients with
triazole-resistance Aspergillus
fumigatus. U.S. data on triazoleresistant Aspergillus fumigatus are
lacking, although this problem
constitutes a major public health threat.
CDC requests OMB approval for an
estimated 8 annual burden hours
annually for collection from 15
respondents. There are no costs to
respondents other than their time.

Through the Antibiotic Resistance
Laboratory Network (ARLN), CDC is
already receiving A. fumigatus isolates
from laboratories across the nation.
These isolates undergo testing for
triazole resistance (defined using
minimum inhibitory concentrations or
epidemiologic cutoff values set forth by
Clinical and Laboratory Standards
Institute). For patients involving
triazole-resistant isolates, we plan to use
a standardized case report form (CRF) to
collect public health surveillance data
regarding demographics (e.g., age, sex,
race/ethnicity, country of residence),
underlying medical conditions,
treatments, and outcomes (e.g., vital
status at 30 days for initial positive
specimen). The CRF would be filled out
voluntarily by state and local health

ESTIMATED ANNUALIZED BURDEN HOURS
Type of
respondents
State and Local Health
Department.
Total ........................

Average
burden per
response
(in hours)

Total Burden
(in hours)

15

15

30/60

8

..............................................................................

........................

........................

........................

8

[FR Doc. 2021–27599 Filed 12–20–21; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention

CDC must receive written
comments on or before February 22,
2022.

Centers for Disease Control and
Prevention (CDC), Department of Health
and Human Services (HHS).
ACTION: Notice with comment period.
AGENCY:

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.

18:02 Dec 20, 2021

Jkt 256001

You may submit comments,
identified by Docket No. CDC–2021–
0130 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 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
regulations.gov.
Please note: Submit all comments
through the Federal eRulemaking portal
(regulations.gov) or by U.S. mail to the
address listed above.

ADDRESSES:

Proposed Data Collection Submitted
for Public Comment and
Recommendations

SUMMARY:

This notice invites comment on a
proposed information collection project
titled 2022 Million Hearts®
Hypertension Control Champions
Challenge. This program will be used to
identify clinicians, clinical practices,
and health systems that have
exceptional rates of hypertension
control and recognize them as 2022
Million Hearts® Hypertension Control
Champions.
DATES:

[60-Day–22–0976; Docket No. CDC–2021–
0130]

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Number of
responses per
respondent

Characteristics of Patients with Environmentallyderived Triazole-resistant Aspergillus
fumigatus.

Jeffrey M. Zirger,
Lead, Information Collection Review Office,
Office of Scientific Integrity, Office of Science,
Centers for Disease Control and Prevention.

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Number of
respondents

Form name

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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; phone:
404–639–7118; Email: [email protected].

FOR FURTHER INFORMATION CONTACT:

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

SUPPLEMENTARY INFORMATION:

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Federal Register / Vol. 86, No. 242 / Tuesday, December 21, 2021 / Notices

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.

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Proposed Project
2022 Million Hearts® Hypertension
Control Champions Challenge (OMB
Control No. 0920–0976, Exp. 11/30/
2022)—Revision—National Center for
Chronic Disease and Public Health
Promotion (NCCDPHP), Centers for
Disease Control and Prevention (CDC).
Background and Brief Description
Million Hearts® is a national initiative
to prevent one million heart attacks and
strokes by 2022. In order to prevent one
million cardiovascular events (e.g., heart
attacks and strokes), we 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
https://millionhearts.hhs.gov/. Million
Hearts® is a registered trademark of the
Department of Health and Human
Services.
The challenge is an important way to
call attention to the need for improved
hypertension control, provides a
powerful motivation and target for

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Jkt 256001

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 2022 Million Hearts®
Hypertension Control Champions. To
support improved quality of care
delivered to patients with hypertension,
Million Hearts® 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 2022 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 the most recent 12-month reporting
period (e.g., 1/1/2021–12/31/2021) and
a previous rate for the 12-month period
immediately preceding the most recent
reporting period (e.g., 1/1/2020–12/31/
2020). 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,
percent enrolled in Medicaid, percent
with no health insurance, and percent
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® 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

PO 00000

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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-

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Federal Register / Vol. 86, No. 242 / Tuesday, December 21, 2021 / Notices
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® website.
Strategies used by Champions that
support hypertension control may be
written into a success story, placed on
the Million Hearts® website, used in
press releases, publications, and
attributed to Champions.

No cash prize will be awarded.
Champions will receive national
recognition. CDC requests OMB
approval for an estimated 215 annual
burden hours. There are no costs to
respondents other than their time to
participate.

ESTIMATED ANNUALIZED BURDEN HOURS
Type of respondents

Physician, practices and
healthcare systems.
Finalists .................................
Champions ............................
Total ...............................

Million Hearts® Hypertension Control
Champion Application Form.
Million Hearts® Hypertension Control
Champion Data Verification Form.
Interview Guide: Million Hearts® Hypertension Control Champion.
.......................................................................

Jeffrey M. Zirger,
Lead, Information Collection Review Office,
Office of Scientific Integrity, Office of Science,
Centers for Disease Control and Prevention.
[FR Doc. 2021–27600 Filed 12–20–21; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[30-Day–22–21FJ]

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Agency Forms Undergoing Paperwork
Reduction Act Review
In accordance with the Paperwork
Reduction Act of 1995, the Centers for
Disease Control and Prevention (CDC)
has submitted the information
collection request titled ‘‘Performance
Monitoring of CDC’s Core State Injury
Prevention Program’’ to the Office of
Management and Budget (OMB) for
review and approval. CDC previously
published a ‘‘Proposed Data Collection
Submitted for Public Comment and
Recommendations’’ notice on July 2,
2021 to obtain comments from the
public and affected agencies. There
were no comments to the previous
notice. This notice serves to allow an
additional 30 days for public and
affected agency comments.
CDC will accept all comments for this
proposed information collection project.
The Office of Management and Budget
is particularly interested in comments
that:
(a) Evaluate whether the proposed
collection of information is necessary

VerDate Sep<11>2014

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Number of
responses per
respondent

Number of
respondents

Form name

Frm 00039

Fmt 4703

Total burden
(in hours)

200

1

30/60

100

40

1

2

80

35

1

1

35

........................

........................

........................

215

for the proper performance of the
functions of the agency, including
whether the information will have
practical utility;
(b) Evaluate the accuracy of the
agencies estimate of the burden of the
proposed collection of information,
including the validity of the
methodology and assumptions used;
(c) Enhance the quality, utility, and
clarity of the information to be
collected;
(d) 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 submission of
responses; and
(e) Assess information collection
costs.
To request additional information on
the proposed project or to obtain a copy
of the information collection plan and
instruments, call (404) 639–7570.
Comments and recommendations for the
proposed information collection should
be sent within 30 days of publication of
this notice to www.reginfo.gov/public/
do/PRAMain. Find this information
collection by selecting ‘‘Currently under
30-day Review—Open for Public
Comments’’ or by using the search
function. Direct written comments and/
or suggestions regarding the items
contained in this notice to the
Attention: CDC Desk Officer, Office of
Management and Budget, 725 17th
Street NW, Washington, DC 20503 or by
fax to (202) 395–5806. Provide written

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burden per
response
(in hours)

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comments within 30 days of notice
publication.
Proposed Project
Performance Monitoring of CDC’s
Core State Injury Prevention Program—
New—National Center for Injury
Prevention and Comtrol (NCIPC),
Centers for Disease Control and
Prevention (CDC).
Background and Brief Description
CDC’s National Center for Injury
Prevention and Control (NCIPC)
requests OMB approval for Performance
Monitoring of CDC’s Core State Injury
Prevention Program (Core SIPP). This
proposed data collection will collect
performance monitoring data via a webbased Partners’ Portal. Data is needed to
monitor the cooperative agreement
program funded under the Core SIPP.
Monitoring the impact of populationbased strategies and identifying new
insights and innovative solutions to
health problems are two of the noted
public health activities that all public
health systems should undertake. For
NCIPC, these objectives cannot be
satisfied without the systematic
collection of data and information from
state health departments. The
information collection will enable the
accurate, reliable, uniform, and timely
submission of each awardee’s progress
report and injury indicators, including
strategies and performance measures.
Information to be collected will
provide crucial data for program
performance monitoring and provide
CDC with the capacity to respond in a
timely manner to requests for
information about the program from the

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