Notice2022-03076
Agency Forms Undergoing Paperwork Reduction Act Review
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
February 14, 2022
Issuing agencies
Health and Human Services DepartmentCenters for Disease Control and Prevention
Full Text
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<title>Federal Register, Volume 87 Issue 30 (Monday, February 14, 2022)</title>
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[Federal Register Volume 87, Number 30 (Monday, February 14, 2022)]
[Notices]
[Pages 8253-8254]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2022-03076]
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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 <a href="http://www.reginfo.gov/public/do/PRAMain">www.reginfo.gov/public/do/PRAMain</a>. 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
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Number of Average burden
Type of respondent Form name Number of responses per per response
respondents respondent (in hours)
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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
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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
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