[Federal Register Volume 86, Number 15 (Tuesday, January 26, 2021)]
[Notices]
[Pages 7094-7095]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-01693]



[[Page 7094]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[30Day-21-1218]


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.

                                        Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
                                                                                                      Average
                                                                     Number of       Number of      burden per
          Type of respondents                   Form name           respondents    responses per   response  (in
                                                                                    respondent        hours)
----------------------------------------------------------------------------------------------------------------
Patients..............................  Client Questionnaire 18-             400               1           45/60
                                         month follow-up.
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[[Page 7095]]

Jeffrey M. Zirger,
Lead, Information Collection Review Office, Office of Scientific 
Integrity, Office of Science, Centers for Disease Control and 
Prevention.
[FR Doc. 2021-01693 Filed 1-25-21; 8:45 am]
BILLING CODE 4163-18-P