Proposed Data Collection Submitted for Public Comment and Recommendations

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.

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