    [Federal Register Volume 85, Number 168 (Friday, August 28, 2020)]
    [Notices]
    [Pages 53376-53377]
    From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
    [FR Doc No: 2020-18997]

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    DEPARTMENT OF HEALTH AND HUMAN SERVICES

    Centers for Disease Control and Prevention

    [60Day-20-1218; Docket No. CDC-2020-0091]

    Proposed Data Collection Submitted for Public Comment and
    Recommendations

    AGENCY: Centers for Disease Control and Prevention (CDC), Department of
    Health and Human Services (HHS).

    ACTION: Notice with comment period.

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    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 and/or
    continuing information collection, as required by the Paperwork
    Reduction Act of 1995. This notice invites comment on a proposed
    information collection project titled ``Evaluation of Medication-
    Assisted Treatment (MAT) for Opioid use disorder.'' CDC will use the
    collection to continue the epidemiologic study to assess the type of
    MAT (methadone maintenance; buprenorphine; naltrexone; or, counseling,
    no MAT), and the contextual, provider, and individual factors that
    influence implementation and improved patient wellbeing.

    DATES: Written comments must be received on or before October 27, 2020.

    ADDRESSES: You may submit comments, identified by Docket No. CDC-2020-
    0091 by any of the following methods:
         Federal eRulemaking Portal: 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-D74, Atlanta, Georgia 30329.
        Instructions: All submissions received must include the agency name
    and Docket Number. CDC will post, without change, all relevant comments
    to Regulations.gov.

        Please note: Submit all comments through the Federal eRulemaking
    portal (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, MS-D74, Atlanta, Georgia 30329; phone: 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; and
        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.
        5. Assess information collection costs.

    Proposed Project

    Evaluation of Medication-Assisted Treatment (MAT) for Opioid Use
    Disorder--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.
    Approximately 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.

    [[Page 53377]]

        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 enable 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 collection instruments, thus there is a reduction in burden of
    3839 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 only cost
    to respondents will be time spent responding to the survey/screener.
    CDC requests approval for 300 annualized burden hours.

                                            Estimated Annualized Burden Hours
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                                                                                          Average
                                                         Number of       Number of      burden per     Total  burden
          Type of respondent            Form name       respondents    responses per   response  (in       hours
                                                                        respondent        hours)
    ----------------------------------------------------------------------------------------------------------------
    Patients......................  Client                       400               1           45/60             300
                                     Questionnaire
                                     18-Month Follow-
                                     up.
                                                     ---------------------------------------------------------------
        Total.....................  ................  ..............  ..............  ..............             300
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    Jeffrey M. Zirger,
    Lead, Information Collection Review Office, Office of Scientific
    Integrity, Office of Science, Centers for Disease Control and
    Prevention.
    [FR Doc. 2020-18997 Filed 8-27-20; 8:45 am]
    BILLING CODE 4163-18-P