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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 [www.gpo.gov]
[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:
     Federal eRulemaking Portal: www.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 www.regulations.gov.
    Please note: Submit all comments through the Federal eRulemaking 
portal (www.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, H 21-8, Atlanta, Georgia 30329; Telephone: 404-639-7570; 
Email: [email protected].

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:
     Aim 1: Dissemination--Assess CDC's efforts in 
disseminating the 2022 CDC Clinical Practice Guideline.
     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.
     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)
----------------------------------------------------------------------------------------------------------------
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.
                                                 ---------------------------------------------------------------
    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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