Att F_Published 60dy FRN

Att. F Published 60-Day Federal Register Notice.pdf

Understanding Health System Approaches to Chronic Pain Management

Att F_Published 60dy FRN

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Federal Register / Vol. 86, No. 184 / Monday, September 27, 2021 / Notices
for Surveillance, Epidemiology and
Laboratory Services, Office of Public
Health Scientific Services, Centers for
Disease Control and Prevention, 1600
Clifton Road NE, Mailstop V24–3,
Atlanta, Georgia 30329–4018,
Telephone: (404) 498–2741; or via email
at CLIAC@cdc.gov.
FOR FURTHER INFORMATION CONTACT:
Heather Stang, MS, Deputy Chief,
Quality and Safety Systems Branch,
Division of Laboratory Systems, Center
for Surveillance, Epidemiology and
Laboratory Services, Office of Public
Health Scientific Services, Centers for
Disease Control and Prevention, 1600
Clifton Road NE, Mailstop V24–3,
Atlanta, Georgia 30329–4018,
Telephone: (404) 498–2769; HStang@
cdc.gov.
SUPPLEMENTARY INFORMATION: The
Committee includes three ex officio
members (or designees), including the
Director, CDC; the Administrator,
Centers for Medicare & Medicaid
Services (CMS); and the Commissioner,
Food and Drug Administration (FDA). A
nonvoting representative from the
Advanced Medical Technology
Association (AdvaMed) serves as the
industry liaison. The Designated Federal
Official (DFO) or their designee and the
Executive Secretary are present at all
meetings to ensure meetings are within
applicable statutory, regulatory, and
HHS General Administration manual
directives.
Nominations are being sought for
individuals who have the expertise and
qualifications necessary to contribute to
the accomplishments of the committee’s
objectives. Nominees will be selected
based on expertise in the fields of
microbiology (including bacteriology,
mycobacteriology, mycology,
parasitology, and virology), immunology
(including histocompatibility),
chemistry, hematology, pathology
(including histopathology and cytology),
or genetic testing (including
cytogenetics); from representatives in
the fields of medical technology,
bioinformatics, public health, and
clinical practice; and from consumer
representatives. Federal employees will
not be considered for membership.
Members may be invited to serve for up
to four-year terms.
Selection of members is based on
candidates’ qualifications to contribute
to the accomplishment of CLIAC
objectives (https://www.cdc.gov/cliac/).
The U.S. Department of Health and
Human Services policy stipulates that
committee membership be balanced in
terms of points of view represented, and
the committee’s function. Appointments
shall be made without discrimination

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on the basis of age, race, ethnicity,
gender, sexual orientation, gender
identity, HIV status, disability, and
cultural, religious, or socioeconomic
status. Nominees must be U.S. citizens,
and cannot be full-time employees of
the U.S. Government. Current
participation on federal workgroups or
prior experience serving on a federal
advisory committee does not disqualify
a candidate; however, HHS policy is to
avoid excessive individual service on
advisory committees and multiple
committee memberships. Committee
members are Special Government
Employees (SGEs), requiring the filing
of financial disclosure reports at the
beginning and annually during their
terms. CDC reviews potential candidates
for CLIAC membership each year and
provides a slate of nominees for
consideration to the Secretary of HHS
for final selection. HHS notifies selected
candidates of their appointment near
the start of the term in July, or as soon
as the HHS selection process is
completed. Note that the need for
different expertise varies from year to
year and a candidate who is not selected
in one year may be reconsidered in a
subsequent year. Candidates should
submit the following items:
D Current curriculum vitae, including
complete contact information
(telephone numbers, mailing address,
email address).
D At least one letter of
recommendation from person(s) not
employed by the U.S. Department of
Health and Human Services.
(Candidates may submit letter(s) from
current HHS employees if they wish,
but at least one letter must be submitted
by a person not employed by an HHS
agency (e.g., CDC, NIH, FDA, etc.).
Nominations may be submitted by the
candidate, or by the person/organization
recommending the candidate.
The Director, Strategic Business
Initiatives Unit, Office of the Chief
Operating Officer, Centers for Disease
Control and Prevention, has been
delegated the authority to sign Federal
Register notices pertaining to
announcements of meetings and other
committee management activities, for
both the Centers for Disease Control and
Prevention and the Agency for Toxic
Substances and Disease Registry.
Kalwant Smagh,
Director, Strategic Business Initiatives Unit,
Office of the Chief Operating Officer, Centers
for Disease Control and Prevention.
[FR Doc. 2021–20925 Filed 9–24–21; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[60Day–21–21IE; Docket No. CDC–2021–
0103]

Proposed Data Collection Submitted
for Public Comment and
Recommendations
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.
This notice invites comment on a
proposed information collection project
titled Understanding Health System
Approaches to Chronic Pain
Management. The proposed study is
designed to evaluate the effects of
evidence-based guidelines related to
chronic pain management and opioid
prescribing.

SUMMARY:

CDC must receive written
comments on or before November 26,
2021.

DATES:

You may submit comments,
identified by Docket No. CDC–2021–
0103 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.

ADDRESSES:

Please note: Submit all comments through
the Federal eRulemaking portal
(regulations.gov) or by U.S. mail to the
address listed above.

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

FOR FURTHER INFORMATION CONTACT:

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Federal Register / Vol. 86, No. 184 / Monday, September 27, 2021 / Notices

H21–8, Atlanta, Georgia 30329; phone:
404–639–7570; Email: omb@cdc.gov.
SUPPLEMENTARY INFORMATION: Under the
Paperwork Reduction Act of 1995 (PRA)
(44 U.S.C. 3501–3520), Federal agencies
must obtain approval from the Office of
Management and Budget (OMB) for each
collection of information they conduct
or sponsor. In addition, the PRA also
requires Federal agencies to provide a
60-day notice in the Federal Register
concerning each proposed collection of
information, including each new
proposed collection, each proposed
extension of existing collection of
information, and each reinstatement of
previously approved information
collection before submitting the
collection to the OMB for approval. To
comply with this requirement, we are
publishing this notice of a proposed
data collection as described below.
The OMB is particularly interested in
comments that will help:
1. Evaluate whether the proposed
collection of information is necessary
for the proper performance of the
functions of the agency, including
whether the information will have
practical utility;
2. Evaluate the accuracy of the
agency’s estimate of the burden of the
proposed collection of information,
including the validity of the
methodology and assumptions used;
3. Enhance the quality, utility, and
clarity of the information to be
collected;
4. Minimize the burden of the
collection of information on those who
are to respond, including through the
use of appropriate automated,
electronic, mechanical, or other
technological collection techniques or
other forms of information technology,
e.g., permitting electronic submissions
of responses; and
5. Assess information collection costs.
Proposed Project
Understanding Health System
Approaches to Chronic Pain
Management—New—National Center
for Injury Prevention and Control

Opioids for Chronic Pain’’) through the
‘‘Generic Clearance for the Collection of
Routine Customer Feedback’’ (OMB
Control No. 0920–1050). This brief
eligibility assessment consisting of
surveys was sent to approximately 250
health systems to understand the
landscape of health systems and the
types of guidelines or policies
implemented, and what strategies were
used to do so. Of 250 health systems
contacted, 46 responded and were
considered for the following
preliminary phase—the evaluability
assessment.
The purpose of this data collection
effort is to: (1) Obtain an enhanced
understanding of facilitators and
barriers to guideline-concordant
management of chronic pain and opioid
prescribing (including access to MOUD)
at the health system level, in order to
improve patient outcomes while
maximizing patient safety and to
facilitate uptake by clinicians and
health systems, (2) describe unintended
benefits and consequences to guideline/
policy implementation, and (3) identify
racial and ethnic disparities in
guideline/policy implementation.
This mixed-methods, pre-post
evaluation of health systems’
implementation of chronic pain
management and opioid prescribing
policies/guidelines, and the resultant
outcomes requires both primary data
collection (such as surveys, key
informant interviews, focus groups,
etc.), and secondary data collection
(such as administrative, EHR, pharmacy
dispensing, prescribing data, etc.) efforts
to adequately answer the research
questions. While secondary data (QI
measures) from health system EHRs will
provide longitudinal pre-post measures,
primary data is needed to understand
the characteristics and mechanisms of
practice and patient change that can be
attributed to the policies and guidelines.
The total burden is estimated to be
577 hours annually. There are no direct
costs to respondents other than their
time to participate in the study.

(NCIPC), Centers for Disease Control
and Prevention (CDC).
Background and Brief Description
CDC requests OMB approval for three
years for this new data collection. This
study will evaluate the effects of
evidence-based guidelines related to
chronic pain management and opioid
prescribing, including access to
medications for opioid use disorder
(MOUD) for patients and clinicians in
primary care settings among a diverse
sample of health systems.
Since 1999, nearly 841,000 people
have died from drug overdose in the
United States. Over 70% of drug
overdose deaths in 2019 involved an
opioid. From 1999 to 2019, nearly
247,000 people died in the United
States from overdoses involving
prescription opioids, with rates of
deaths involving prescription opioids
more than quadrupling from 1999 to
2019. In response, a range of clinical
practice guidelines, policies, and
regulations have been released in recent
years to address the opioid overdose
epidemic, with the goals of supporting
safer opioid prescribing, improving
diagnosis and treatment of OUD, and
reducing overdose deaths in the United
States.
To design this evaluation, we
previously conducted and completed a
‘‘Feasibility Assessment of Health
Systems’’ via surveys to determine the
range of policies and guidelines being
implemented by health systems,
followed by an ‘‘evaluability
assessment’’ by means of interviews
with leaders of nine health systems. For
the purposes of this evaluation,
‘‘Chronic pain management policies/
guidelines’’ refers to policies/guidelines
that may include prescribing of opioid
medications, nonpharmacologic
therapies, and/or non-opioid
medications for chronic pain, as well as
OUD assessment and treatment.
In early 2020, CDC requested OMB
approval for a Feasibility Assessment of
Health Systems (‘‘Feedback on the use
of the CDC Guideline for Prescribing

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ESTIMATED ANNUALIZED BURDEN HOURS
Number of
respondents

Number of
responses per
respondent

Average
burden per
response
(in hours)

Total burden
(in hours)

Type of respondent

Form name

Patient ...............................................
Treatment facility staff (Including primary care clinicians, health system leaders, and other system
staff and representatives).

Patient Survey ..................................
Primary Care Clinician Survey .........
Invitation/Follow up Email ................

667
1,313
1,980

1
1
2

10/60
10/60
3/60

111
219
198

Health System Leaders Group Interview Guide.
Case Study Interview Guide ............

17

1

1

17

30

1

30/60

15

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Federal Register / Vol. 86, No. 184 / Monday, September 27, 2021 / Notices
ESTIMATED ANNUALIZED BURDEN HOURS—Continued
Type of respondent

Member Checking (Validation) Sessions Interview Guide.
Total ...........................................

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

Jeffrey M. Zirger,
Lead, Information Collection Review Office,
Office of Scientific Integrity, Office of Science,
Centers for Disease Control and Prevention.
[FR Doc. 2021–20843 Filed 9–24–21; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention

Proposed Data Collection Submitted
for Public Comment and
Recommendations
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.
This notice invites comment on an
existing information collection project
titled the CDC Worksite Health
Scorecard. The collection is an
organizational assessment and planning
tool designed to help employers identify
gaps in their health promotion programs
and prioritize high-impact strategies for
health promotion at their worksites.
DATES: CDC must receive written
comments on or before November 26,
2021.
SUMMARY:

You may submit comments,
identified by Docket No. CDC–2021–
0099 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

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1

17

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

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

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

577

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:
404–639–7570; Email: omb@cdc.gov.
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;

SUPPLEMENTARY INFORMATION:

Frm 00054

Fmt 4703

Total burden
(in hours)

1

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.

PO 00000

Average
burden per
response
(in hours)

17

FOR FURTHER INFORMATION CONTACT:

[60Day–21–1014; Docket No. CDC–2021–
0099]

ADDRESSES:

Number of
responses per
respondent

Number of
respondents

Form name

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3. Enhance the quality, utility, and
clarity of the information to be
collected;
4. Minimize the burden of the
collection of information on those who
are to respond, including through the
use of appropriate automated,
electronic, mechanical, or other
technological collection techniques or
other forms of information technology,
e.g., permitting electronic submissions
of responses; and
5. Assess information collection costs.
Proposed Project
CDC Worksite Health ScoreCard (CDC
ScoreCard) (OMB Control No. 0920–
1014, Exp. 3/31/2022)—Extension—
National Center for Chronic Disease
Prevention and Health Promotion
(NCCDPHP), Centers for Disease Control
and Prevention (CDC).
Background and Brief Description
In the United States, chronic diseases
such as heart disease, obesity, and
diabetes are among the leading causes of
death and disability. Although chronic
diseases are among the most common
and costly health problems, they are
also among the most preventable.
Adopting healthy behaviors—such as
eating nutritious foods, being physically
active, and avoiding tobacco use—can
prevent the devastating effects and
reduce the rates of these diseases.
Employers are recognizing the role
they can play in creating healthy work
environments and providing employees
with opportunities to make healthy
lifestyle choices. To support these
efforts, the Centers for Disease Control
and Prevention (CDC) developed an
online organizational assessment tool
called the CDC Worksite Health
Scorecard.
The CDC Worksite Health Scorecard
is a tool designed to help employers
assess whether they have implemented
evidence-based health promotion
interventions or strategies in their
worksites to prevent heart disease,
stroke, and related conditions such as
hypertension, diabetes, and obesity. The
assessment contains 151 core yes/no
questions with an additional 20 optional
demographic questions divided into 19

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