Notice2021-20843
Proposed Data Collection Submitted for Public Comment and Recommendations
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
September 27, 2021
Issuing agencies
Health and Human Services DepartmentCenters for Disease Control and Prevention
Abstract
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.
Full Text
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<title>Federal Register, Volume 86 Issue 184 (Monday, September 27, 2021)</title>
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[Federal Register Volume 86, Number 184 (Monday, September 27, 2021)]
[Notices]
[Pages 53313-53315]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2021-20843]
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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
AGENCY: Centers for Disease Control and Prevention (CDC), Department of
Health and Human Services (HHS).
ACTION: Notice with comment period.
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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 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.
DATES: CDC must receive written comments on or before November 26,
2021.
ADDRESSES: You may submit comments, identified by Docket No. CDC-2021-
0103 by any of the following methods:
<bullet> Federal eRulemaking Portal: <a href="http://Regulations.gov">Regulations.gov</a>. Follow the
instructions for submitting comments.
<bullet> 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 <a href="http://Regulations.gov">Regulations.gov</a>.
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
[[Page 53314]]
H21-8, Atlanta, Georgia 30329; phone: 404-639-7570; Email: <a href="/cdn-cgi/l/email-protection#4b2426290b282f28652c243d"><span class="__cf_email__" data-cfemail="c2adafa082a1a6a1eca5adb4">[email protected]</span></a>.
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 (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 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.
Estimated Annualized Burden Hours
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Number of Average burden
Type of respondent Form name Number of responses per per response Total burden
respondents respondent (in hours) (in hours)
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Patient....................... Patient Survey.. 667 1 10/60 111
Treatment facility staff Primary Care 1,313 1 10/60 219
(Including primary care Clinician 1,980 2 3/60 198
clinicians, health system Survey.
leaders, and other system Invitation/
staff and representatives). Follow up Email.
Health System 17 1 1 17
Leaders Group
Interview Guide.
Case Study 30 1 30/60 15
Interview Guide.
[[Page 53315]]
Member Checking 17 1 1 17
(Validation)
Sessions
Interview Guide.
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Total..................... ................ .............. .............. .............. 577
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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. 2021-20843 Filed 9-24-21; 8:45 am]
BILLING CODE 4163-18-P
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