82 FR 27832 - Proposed Data Collection Submitted for Public Comment and Recommendations

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention

Federal Register Volume 82, Issue 116 (June 19, 2017)

The Centers for Disease Control and Prevention (CDC), as part of its continuing efforts to reduce public burden and maximize the utility of government information, invites the general public and other Federal agencies to take this opportunity to comment on proposed and/or continuing information collections, as required by the Paperwork Reduction Act of 1995. This notice invites comment on a proposed information collection entitled ``Evaluation of Medication-Assisted Treatment (MAT) for Opioid use disorder.'' CDC will use the collection to conduct an 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 over a two-year follow up period.

[Federal Register Volume 82, Number 116 (Monday, June 19, 2017)]
[Notices]
[Pages 27832-27833]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2017-12736]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[60Day-17-17ACE; Docket No. CDC-2017-0043]


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.

-----------------------------------------------------------------------

SUMMARY: The Centers for Disease Control and Prevention (CDC), as part 
of its continuing efforts to reduce public burden and maximize the 
utility of government information, invites the general public and other 
Federal agencies to take this opportunity to comment on proposed and/or 
continuing information collections, as required by the Paperwork 
Reduction Act of 1995. This notice invites comment on a proposed 
information collection entitled ``Evaluation of Medication-Assisted 
Treatment (MAT) for Opioid use disorder.'' CDC will use the collection 
to conduct an 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 over a two-year follow up 
period.

DATES: Written comments must be received on or before August 18, 2017.

ADDRESSES: You may submit comments, identified by Docket No. CDC-2017-
0043 by any of the following methods:
     Federal eRulemaking Portal: Regulations.gov. Follow the 
instructions for submitting comments.
     Mail: Leroy A. Richardson, 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. All relevant comments received will be posted 
without change to Regulations.gov, including any personal information 
provided. For access to the docket to read background documents or 
comments received, go to Regulations.gov.

    Please note: All public comment should be submitted 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 Leroy A. Richardson, 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 OMB for approval. To 
comply with this requirement, we are publishing this notice of a 
proposed data collection as described below.
    Comments are invited on: (a) Whether the proposed collection of 
information is necessary for the proper performance of the functions of 
the agency, including whether the information shall have practical 
utility; (b) the accuracy of the agency's estimate of the burden of the 
proposed collection of information; (c) ways to enhance the quality, 
utility, and clarity of the information to be collected; (d) ways to 
minimize the burden of the collection of information on respondents, 
including through the use of automated collection techniques or other 
forms of information technology; and (e) estimates of capital or start-
up costs and costs of operation, maintenance, and purchase of services 
to provide information. Burden means the total time, effort, or 
financial resources expended by persons to generate, maintain, retain, 
disclose or provide information to or for a Federal agency. This 
includes the time needed to review instructions; to develop, acquire, 
install and utilize technology

[[Page 27833]]

and systems for the purpose of collecting, validating and verifying 
information, processing and maintaining information, and disclosing and 
providing information; to train personnel and to be able to respond to 
a collection of information, to search data sources, to complete and 
review the collection of information; and to transmit or otherwise 
disclose the information.

Proposed Project

    Evaluation of Medication-Assisted Treatment (MAT) for Opioid use 
disorder--New--National Center for Injury Prevention and Control 
(NCIPC), Centers for Disease Control and Prevention (CDC).

Background and Brief Description

    CDC seeks a three-year OMB approval to collect evaluation 
information 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 evaluation is to conduct an epidemiologic, 
mixed-methods evaluation of OUD treatment in real-world outpatient 
settings. The study aims to have 3,000 participants from real-world 
outpatient settings to better understand the relationship between type 
of MAT and individual, provider, and contextual characteristics related 
to retention in treatment and abstinence from opioid use. The sites 
will be located across 10 diverse metropolitan statistical areas (MSAs) 
with four sites in each MSA. At each site, about 75 participants are 
expected to participate for a total of 300 per MSA. Across all MSAs, 
the study will aim to have 750 client participants in each of the four 
treatment conditions (MMT, BUP, NAL, and COUN).
    The study will use 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. The only cost to respondents will be time spent responding to 
the survey/screener.

                                        Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
                                                                     Number of    Average burden
      Type of respondents        Instrument name     Number of     responses per   per response    Total burden
                                                    respondents     respondent        (hours)         (hours)
----------------------------------------------------------------------------------------------------------------
Provider site staff...........  Client                        15             100            5/60             125
                                 Permission Form.
                                Visit Form......              15             525           10/60           1,313
                                Site Director                 15               2               1              30
                                 Questionnaire.
                                Focus Groups....              27               1           90/60              41
Client respondents............  Client Screener.           1,333               1            5/60             111
                                Client Check-in.           1,000               2           15/60             500
                                Client                     2,412               1           49/60           1,978
                                 Questionnaire.
                                Focus Groups....              27               1           90/60              41
    Total.....................                                                                             4,139
----------------------------------------------------------------------------------------------------------------


Leroy A. Richardson,
Chief, Information Collection Review Office, Office of Scientific 
Integrity, Office of the Associate Director for Science, Office of the 
Director, Centers for Disease Control and Prevention.
[FR Doc. 2017-12736 Filed 6-16-17; 8:45 am]
BILLING CODE 4163-18-P