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 Department of Health and Human Services Centers for Disease Control and Prevention [60Day-24-24IV; Docket No. CDC-2024-0071]
 AGENCY: Centers for Disease Control and Prevention (CDC), Department of Health and Human Services (HHS).
 ACTION: Notice with comment period.
 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: 
                        *omb@cdc.gov.*


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.
                    ( print 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 Type of respondents
Form name
Number of
                             respondents
Number of
                             responses per 
                             respondent
Average
                             burden per 
                             response 
                             (in hours)
Total burden (in hours)Clinicians
Clinician Survey
200
1
10/60
33Invitation
1,000
1
5/60
83Follow up Emails
1,000
1
5/60
83Clinician Interview
10
1
1
10Dentists
Dentist Interview
2
1
1
2Health System Leaders
Health System Leaders Interview
3
2
1
6Payers
Payer Interview
3
2
1
6Professional Association Leaders
Professional Association Leaders Interview
3
2
1
6Medical Board Leaders
Medical Board Leaders Interview
3
2
1
6Patients
Patient Focus Groups
15
3
1
45Caregivers
Caregiver Focus Groups
15
2
1
30Total




325
 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