82 FR 57757 - Agency Forms Undergoing Paperwork Reduction Act Review

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

Federal Register Volume 82, Issue 234 (December 7, 2017)

[Federal Register Volume 82, Number 234 (Thursday, December 7, 2017)]
[Notices]
[Pages 57757-57758]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2017-26399]



[[Page 57757]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[30Day-17-17ACE]


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 Disorders 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 
June, 19, 2017 to obtain comments from the public and affected 
agencies. CDC received three 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 or send an email to [email protected]. 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

    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

    This is a new Information Collection Request. CDC requests a three-
year OMB approval.
    About 2 million people aged 12 or older in the United States have 
Opioid Use Disorders (OUDs) related to prescription opioids and almost 
600,000 have OUDs related to heroin use (SAMHSA, 2015). OUD is a 
problematic pattern of opioid use that cause significant impairment or 
distress characterized by unsuccessful efforts to control use and 
failures to fulfill obligations social, at work, or school, yet many of 
these people do not receive OUD treatment. Given the continued need for 
treatment and the urgency of the opioid epidemic, further understanding 
of the individual and contextual factors that may impact treatment 
outcomes is needed. To help address this need, the CDC is conducting a 
study of 60 Opioid Use Disorder (OUD) treatment facilities and four 
primary care facilities located in 11 metropolitan statistical areas 
across the United States. The respondent universe includes individuals 
in the United States who receive some form of OUD treatment in the 11 
MSAs.
    Prospective participants will be eligible if they are 18 to 64 
years of age and initiating one of four primary treatments for OUD: 
Methadone maintenance treatment (MMT), buprenorphine (BUP), naltrexone 
(NTX), or counseling treatment without medication (COUN). The study 
aims to enroll 3,560 clients across all sites to better understand the 
relationship between type of Medication Assisted Treatment (MAT) and 
individual and treatment facility characteristics, and contextual 
factors.
    The information gained from this data collection will help inform 
policy makers, communities, and providers on how individual 
characteristics and contextual factors may impact client outcomes. The 
MAT study will also provide a unique perspective for three reasons: (1) 
It assesses the treatment, individual, and contextual factors that 
influence implementation and outcomes in real-world settings; (2) its 
large target sample size (n = 3,560); and, (3) the long follow-up 
window (i.e., 24-month follow-up period with clients). CDC has 
collaborated with other relevant federal agencies to avoid duplication 
and maximize efficiencies in data collection. The MAT Study design and 
protocols have been reviewed and shared with colleagues from the 
Substance Abuse and Mental Health Services Administration (SAMHSA) and 
the National Institute on Drug Abuse (NIDA).
    Four overarching evaluation questions guide the MAT Study. These 
questions drive the research design, and CDC developed this data 
collection effort to, specifically, address these evaluation questions. 
This data collection effort captures a series of outcome measures 
including the associated benefits (e.g., reductions in morbidity, 
mortality, and drug overdoses; improvements in socioeconomic outcomes 
and health-related quality of life [HRQOL]) and potential risks (e.g., 
side effects, diversion potential) of each treatment alternative.
    The study will use a mixed-methods approach using quantitative 
methods such as multilevel latent growth models, propensity score 
matching, latent class analysis and advanced mediation analysis and 
qualitative methods such as interactive coding and analysis for common 
themes.
    The total estimated annualized burden for this collection is 3,093 
hours. The only cost to respondents will be time spent responding to 
the surveys.

                                        Estimated Annualized Burden Hours
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                                                                                     Number of    Average burden
          Type of respondents                   Form name            Number of     responses per   per response
                                                                    respondents     respondent      (in hours)
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Clients...............................  Client Screener.........           1,583               1            5/60
                                        Client Check-In.........           1,187               2           15/60

[[Page 57758]]

 
                                        Client Questionnaire               1,187               1           52/60
                                         Baseline.
                                        Client Questionnaire 12-             930               1           45/60
                                         Month Follow-up.
                                        Client Questionnaire 24-             744               1           45/60
                                         Month Follow-up.
                                        Client Focus Groups.....              27               1           90/60
Treatment facility staff..............  Staff Focus Groups......              27               1           90/60
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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. 2017-26399 Filed 12-6-17; 8:45 am]
 BILLING CODE 4163-18-P