[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: 
[email protected].

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)
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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