Notice2024-22474
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
October 1, 2024
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 information collection, as required by the Paperwork Reduction Act of 1995. This notice invites comment on a proposed information collection project titled "Comprehensive Evaluation of the Implementation and Uptake of the CDC Clinical Practice Guideline for Prescribing Opioids for Pain". This data collection is designed to allow CDC to evaluate the 2022 CDC Clinical Practice Guidelines for opioid prescription practices.
Full Text
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<title>Federal Register, Volume 89 Issue 190 (Tuesday, October 1, 2024)</title>
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[Federal Register Volume 89, Number 190 (Tuesday, October 1, 2024)]
[Notices]
[Pages 79925-79926]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2024-22474]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[60Day-24-24IV; Docket No. CDC-2024-0071]
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 information
collection, as required by the Paperwork Reduction Act of 1995. This
notice invites comment on a proposed information collection project
titled ``Comprehensive Evaluation of the Implementation and Uptake of
the CDC Clinical Practice Guideline for Prescribing Opioids for Pain''.
This data collection is designed to allow CDC to evaluate the 2022 CDC
Clinical Practice Guidelines for opioid prescription practices.
DATES: CDC must receive written comments on or before December 2, 2024.
ADDRESSES: You may submit comments, identified by Docket No. CDC-2024-
0071 by either of the following methods:
<bullet> Federal eRulemaking Portal: <a href="http://www.regulations.gov">www.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://www.regulations.gov">www.regulations.gov</a>.
Please note: Submit all comments through the Federal eRulemaking
portal (<a href="http://www.regulations.gov">www.regulations.gov</a>) 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, H 21-8, Atlanta, Georgia 30329; Telephone: 404-639-7570;
Email: <a href="/cdn-cgi/l/email-protection#0966646b496a6d6a276e667f"><span class="__cf_email__" data-cfemail="57383a351734333479303821">[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
Comprehensive Evaluation of the Implementation and Uptake of the
CDC Clinical Practice Guideline for Prescribing Opioids for Pain--New--
National Center for Injury Prevention and Control (NCIPC), Centers for
Disease Control and Prevention (CDC).
Background and Brief Description
Beginning in the 1990s, opioid prescribing rates for pain
management steadily increased until 2010, remained steady until 2012,
and have declined since then. The increase in opioid prescribing rates
corresponded with increases in opioid-involved overdose deaths, which
initially primarily involved prescription opioids (natural and semi-
synthetic opioids and methadone). In response to this emerging crisis,
CDC issued the CDC Guideline for Prescribing Opioids for Chronic Pain--
United States, 2016 (2016 CDC Guideline). Implementing the 2016 CDC
Guideline was associated with reductions in opioid prescribing and
increases in use of non-opioid medications for pain. At the same time,
laws and policies related to prescribing opioids were instituted that
misapplied or were inconsistent with the 2016 CDC Guideline,
potentially contributing to patient harm. In 2022, CDC released the CDC
Clinical Practice Guideline for Prescribing Opioids for Pain--United
States, 2022, which provided up to date evidence regarding pain
management approaches and re-emphasizes the need for prescribers to be
focused on patient-centered care to provide effective pain management.
CDC is comprehensively evaluating the uptake, implementation, and
outcomes of the 2022 CDC Clinical Practice Guideline on evidence-based
care for pain management to understand its impact.
[[Page 79926]]
To meet CDC's goal for a rigorous, comprehensive evaluation, this
collection is proposing a mixed-method quasi-experimental design with
the following three aims to evaluate the 2022 CDC Clinical Practice
Guideline:
<bullet> Aim 1: Dissemination--Assess CDC's efforts in
disseminating the 2022 CDC Clinical Practice Guideline.
<bullet> Aim 2: Impact--Evaluate the impact of the 2022 CDC
Clinical Practice Guideline through population-wide changes in
prescribing practices for opioids and medications for opioid use
disorder.
<bullet> Aim 3: Implementation--Evaluate the implementation of the
2022 CDC Clinical Practice Guideline from perspectives of patients,
caregivers, clinicians; and leaders from health systems, payers,
professional associations, and medical boards.
This evaluation will include systematic collection and analysis of
a range of primary and secondary data sources. To answer the research
questions, we will employ qualitative synthesis and analytic
approaches, quantitative analyses, and various mixed-methods
approaches. Primary data collection efforts include a web-based survey
conducted among a national sample of clinicians, virtual interviews
with clinicians, virtual interviews with dentists, virtual interviews
with leaders from professional organizations, payers, medical boards,
and health systems, and virtual focus groups with patients and
caregivers.
The CDC will use this information collection to evaluate the
dissemination, impact, and implementation of the 2022 CDC Clinical
Practice Guideline to ensure that Americans have access to safer,
effective ways of managing their pain. CDC requests OMB approval for an
estimated 325 annual burden hours. There is no cost to respondents
other than their time.
Estimated Annualized Burden Hours
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Number of Average burden
Type of respondents Form name Number of responses per per response Total burden
respondents respondent (in hours) (in hours)
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Clinicians.................... Clinician Survey 200 1 10/60 33
Invitation...... 1,000 1 5/60 83
Follow up Emails 1,000 1 5/60 83
Clinician 10 1 1 10
Interview.
Dentists...................... Dentist 2 1 1 2
Interview.
Health System Leaders......... Health System 3 2 1 6
Leaders
Interview.
Payers........................ Payer Interview. 3 2 1 6
Professional Association Professional 3 2 1 6
Leaders. Association
Leaders
Interview.
Medical Board Leaders......... Medical Board 3 2 1 6
Leaders
Interview.
Patients...................... Patient Focus 15 3 1 45
Groups.
Caregivers.................... Caregiver Focus 15 2 1 30
Groups.
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Total..................... ................ .............. .............. .............. 325
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Jeffrey M. Zirger,
Lead, Information Collection Review Office, Office of Public Health
Ethics and Regulations, Office of Science, Centers for Disease Control
and Prevention.
[FR Doc. 2024-22474 Filed 9-30-24; 8:45 am]
BILLING CODE 4163-18-P
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