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Federal Register / Vol. 86, No. 15 / Tuesday, January 26, 2021 / Notices
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and Prevention 30Day211218

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 MedicationAssisted 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 6397570.
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 ReviewOpen 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 3955806. Provide written comments within 30 days of notice publication.
Proposed Project Medication-Assisted Treatment MAT for Opioid Use Disorder Study OMB Control No. 09201218, Exp. 02/
28/2021RevisionNational 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 selfhelp treatments i.e., counseling without medication COUN. The rise in opioid overdose deaths, up from 20142015

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, mixedmethods 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.

ESTIMATED ANNUALIZED BURDEN HOURS
Number of respondents
Type of respondents
Form name
Patients

Client Questionnaire 18-month follow-up

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400

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Number of responses per respondent 1

Average burden per response in hours 45/60