Agency Forms Undergoing Paperwork Reduction Act Review

In accordance with the Paperwork Reduction Act of 1995, the Centers for Disease Control and Prevention (CDC) has submitted the information collection request titled “Medication-Assisted Treatment (MAT) for Opioid Use Disorder Study” to the Office of Management and Budget (OMB) for review and approval. CDC previously published a “Proposed Data Collection Submitted for Public Comment and Recommendations” notice on August 28, 2020, to obtain comments from the public and affected agencies. CDC received two comments related to the previous notice. This notice serves to allow an additional 30 days for public and affected agency comments.

CDC will accept all comments for this proposed information collection project. The Office of Management and Budget is particularly interested in comments that:

(a) 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;

(b) Evaluate the accuracy of the agencies estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used;

(c) Enhance the quality, utility, and clarity of the information to be collected;

(d) 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 submission of responses; and

(e) Assess information collection costs.

To request additional information on the proposed project or to obtain a copy of the information collection plan and instruments, call (404) 639-7570. Comments and recommendations for the proposed information collection should be sent within 30 days of publication of this notice to www.reginfo.gov/public/do/PRAMain. Find this particular information collection by selecting “Currently under 30-day Review—Open for Public Comments” or by using the search function. Direct written comments and/or suggestions regarding the items contained in this notice to the Attention: CDC Desk Officer, Office of Management and Budget, 725 17th Street NW, Washington, DC 20503 or by fax to (202) 395-5806. Provide written comments within 30 days of notice publication.

Proposed Project

Medication-Assisted Treatment (MAT) for Opioid Use Disorder Study (OMB Control No. 0920-1218, Exp. 02/28/2021)—Revision—National Center for Injury Prevention and Control (NCIPC), Centers for Disease Control and Prevention (CDC).

Background and Brief Description

CDC seeks a one-year OMB approval to continue collecting data for Medication-Assisted Treatment (MAT) for Opioid use disorder. About 2.4 million people aged 18 or older have opioid use disorders (OUDs) in the United States. At any given time, only half of these people receive some form of treatment, which may include medication-assisted treatment (MAT) or abstinence-based psychotherapy or self-help treatments (i.e., counseling without medication [COUN]). The rise in opioid overdose deaths, up from 2014-2015 due partly to a 72% rise in synthetic opioid overdose deaths alone, shows that engaging and retaining clients in OUD treatment is an urgent public health need. Only a few studies are available to help clients and providers make informed decisions about the risks and benefits associated with the different types of MATs. This information is crucial because even though each MAT drug helps prevent withdrawal symptoms and decreases cravings, differences in treatment approach and settings influence how people respond to the medication and, thus, their long-term treatment success.

The purpose of this study is to conduct an epidemiologic, mixed-methods evaluation of OUD treatment in real-world outpatient settings. Client recruitment for this study was originally scheduled to take place between 5/1/2018 and 8/31/2019, however patient recruitment levels were lower than originally anticipated. The recruitment period was extended to 11/30/2019 to recruit additional patients. Because the follow-up period for this study is 18 months, patients recruited during the extended recruitment period (8/31/2019 to 11/30/2019) will need to complete their final 18-month Patient Questionnaire between 2/28/2021 and 5/31/2021, which is after the current OMB expiration date. The extended time period is only needed for one of the data collections instruments, thus there is a reduction in burden of 2,793 hours.

The study uses a mixed-method approach using quantitative methods such as multilevel latent growth models, propensity score matching, latent class analysis and advance mediation analysis and qualitative methods such as interactive coding and analysis for common themes. There are no costs to respondents other than their time. The total estimated burden will be 300 hours.