Agency Forms Undergoing Paperwork Reduction Act Review, 8253-8254 [2022-03076]
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Federal Register / Vol. 87, No. 30 / Monday, February 14, 2022 / Notices
social, educational, and quality of life
outcomes beyond infancy and early
childhood. However, existing U.S.
population-based data are lacking on
these outcomes among those born with
CHD and the changes that may occur
with time and age. U.S. data is needed
to provide insight into the public health
questions that remain for this
population and to develop services and
allocate resources to improve long-term
health and well-being.
For this project, we will use data from
U.S. state birth defect surveillance
systems, or population-based studies
derived from them, to identify a
population-based sample of children
and adolescents 2–17 years of age born
We estimate receiving completed
surveys from 7,667 caregivers of
children and adolescents with CHD in
the birth defects surveillance systems.
To generate sufficient sample size,
accounting for non-response, from
caregivers up to 17 years after the birth
of their child with CHD, we intend to
sample 100% of eligible CHD cases
identified through select birth defect
surveillance systems. The survey takes
approximately 20 minutes to complete.
Therefore, we estimate the total annual
burden to be 2,556 hours. There are no
costs to participants other than their
time.
with CHD. We will then use state
databases and online search engines to
find current addresses for those
individuals and mail surveys to their
caregivers inquiring about the child’s
cardiac and other healthcare utilization,
barriers to healthcare, quality of life,
social and educational outcomes, and
transition of care from childhood to
adulthood, as well as needs and
experiences of the caregivers. The
information collected from this
population-based survey will be used to
inform current knowledge, allocate
resources, develop services, and,
ultimately, improve long-term health of
children and adolescents born with
CHD.
ESTIMATED ANNUALIZED BURDEN HOURS
Average
burden
per response
(in hours)
Total burden
(in hours)
Form name
Caregivers of individuals aged 2–17
years with a CHD.
Survey questionnaire .......................
7,667
1
20/60
2,556
Total ...........................................
...........................................................
........................
........................
........................
2,556
Jeffrey M. Zirger,
Lead, Information Collection Review Office,
Office of Scientific Integrity, Office of Science,
Centers for Disease Control and Prevention.
[FR Doc. 2022–03077 Filed 2–11–22; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[30–Day–22–21IE]
Agency Forms Undergoing Paperwork
Reduction Act Review
jspears on DSK121TN23PROD with NOTICES1
Number of
responses per
respondent
Number of
respondents
Type of respondents
In accordance with the Paperwork
Reduction Act of 1995, the Centers for
Disease Control and Prevention (CDC)
has submitted the information
collection request titled’’ Understanding
Health System Approaches to Chronic
Pain Management’’ 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 Sept. 27,
2021 to obtain comments from the
public and affected agencies. CDC did
not receive comments related 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.
VerDate Sep<11>2014
18:55 Feb 11, 2022
Jkt 256001
The Office of Management and Budget
is particularly interested in comments
that:
(a) 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;
(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 particular
information collection by selecting
PO 00000
Frm 00027
Fmt 4703
Sfmt 4703
‘‘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
comments within 30 days of notice
publication.
Proposed Project
Understanding Health System
Approaches to Chronic Pain
Management—New—National Center
for Injury Prevention and Control
(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 is designed to 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
E:\FR\FM\14FEN1.SGM
14FEN1
8254
Federal Register / Vol. 87, No. 30 / Monday, February 14, 2022 / Notices
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
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. Among the 46 health
systems who completed the feasibility
assessment surveys, nine were selected
for a more in-depth ‘‘evaluability
assessment’’ based on several factors
identified in the initial feasibility
(survey) assessment, as well as other
expert knowledge of potential systems.
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.
CDC requests OMB approval for an
estimated 577 annual burden hours.
There are no direct costs to respondents
other than their time to participate in
the study.
ESTIMATED ANNUALIZED BURDEN HOURS
Form name
Patient ............................................................................................................
Treatment facility staff (Including primary care clinicians, health system
leaders, and other system staff and representatives).
Patient Survey ...................................
Clinician Survey ................................
Invitation/Follow up Email .................
System Leaders Interview Guide ......
Case Study .......................................
Member Checking Sessions .............
Jeffrey M. Zirger,
Lead, Information Collection Review Office,
Office of Scientific Integrity, Office of Science,
Centers for Disease Control and Prevention.
[FR Doc. 2022–03076 Filed 2–11–22; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[60–Day–22–1283; Docket No. CDC–2022–
0019]
jspears on DSK121TN23PROD with NOTICES1
Number of
respondents
Type of respondent
Proposed Data Collection Submitted
for Public Comment and
Recommendations
Centers for Disease Control and
Prevention (CDC), Department of Health
and Human Services (HHS).
AGENCY:
VerDate Sep<11>2014
17:54 Feb 11, 2022
Jkt 256001
ACTION:
Notice with comment period.
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 Monitoring and Reporting for the
Overdose Data to Action Co-Operative
Agreement. Information collected will
provide crucial data for program
performance monitoring, budget
tracking, and where applicable, program
success for programs funded under
Overdose Data to Action (CDC–RFA–
CE19–1904).
SUMMARY:
PO 00000
Frm 00028
Fmt 4703
Sfmt 4703
667
1,313
1,980
17
30
17
Number of
responses per
respondent
1
1
2
1
1
1
Average
burden per
response
(in hours)
10/60
10/60
3/60
1
30/60
1
CDC must receive written
comments on or before April 15, 2022.
DATES:
You may submit comments,
identified by Docket No. CDC–2022–
0019 by either 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:
E:\FR\FM\14FEN1.SGM
14FEN1
Agencies
[Federal Register Volume 87, Number 30 (Monday, February 14, 2022)]
[Notices]
[Pages 8253-8254]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-03076]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[30-Day-22-21IE]
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'' Understanding Health System Approaches to
Chronic Pain Management'' 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
Sept. 27, 2021 to obtain comments from the public and affected
agencies. CDC did not receive comments related 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 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 particular
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 comments within 30 days of notice
publication.
Proposed Project
Understanding Health System Approaches to Chronic Pain Management--
New--National Center for Injury Prevention and Control (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 is designed to 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
[[Page 8254]]
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 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. Among the 46
health systems who completed the feasibility assessment surveys, nine
were selected for a more in-depth ``evaluability assessment'' based on
several factors identified in the initial feasibility (survey)
assessment, as well as other expert knowledge of potential systems.
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.
CDC requests OMB approval for an estimated 577 annual burden hours.
There are no direct costs to respondents other than their time to
participate in the study.
Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
Number of Average burden
Type of respondent Form name Number of responses per per response
respondents respondent (in hours)
----------------------------------------------------------------------------------------------------------------
Patient............................... Patient Survey.......... 667 1 10/60
Treatment facility staff (Including Clinician Survey........ 1,313 1 10/60
primary care clinicians, health Invitation/Follow up 1,980 2 3/60
system leaders, and other system Email.
staff and representatives).
System Leaders Interview 17 1 1
Guide.
Case Study.............. 30 1 30/60
Member Checking Sessions 17 1 1
----------------------------------------------------------------------------------------------------------------
Jeffrey M. Zirger,
Lead, Information Collection Review Office, Office of Scientific
Integrity, Office of Science, Centers for Disease Control and
Prevention.
[FR Doc. 2022-03076 Filed 2-11-22; 8:45 am]
BILLING CODE 4163-18-P