[Federal Register Volume 86, Number 192 (Thursday, October 7, 2021)]
[Notices]
[Pages 55854-55855]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-21963]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Substance Abuse and Mental Health Services Administration


Agency Information Collection Activities: Submission for OMB 
Review; Comment Request

    Periodically, the Substance Abuse and Mental Health Services 
Administration (SAMHSA) will publish a summary of information 
collection requests under OMB review, in compliance with the Paperwork 
Reduction Act (44 U.S.C. Chapter 35). To request a copy of these 
documents, call the SAMHSA Reports Clearance Officer on (240) 276-0361.

Project: Opioid Drugs in Maintenance and Detoxification Treatment of 
Opioid Dependence--42 CFR Part 8 (OMB No. 0930-0206) and Opioid 
Treatment Programs (OTPs)--Extension

    42 CFR part 8 establishes a certification program managed by 
SAMHSA's Center for Substance Abuse Treatment (CSAT). The regulation 
requires that Opioid Treatment Programs (OTPs) be certified. 
``Certification'' is the process by which SAMHSA determines that an OTP 
is qualified to provide opioid treatment under the Federal opioid 
treatment standards established by the Secretary of Health and Human 
Services. To become certified, an OTP must be accredited by a SAMHSA-
approved accreditation body. The regulation also provides standards for 
such services as individualized treatment planning, increased medical 
supervision, and assessment of patient outcomes. This submission seeks 
continued approval of the information collection requirements in the 
regulation and of the forms used in implementing the regulation.
    SAMHSA currently has approval for the Application for Certification 
to Use Opioid Drugs in a Treatment Program Under 42 CFR 8.11 (Form SMA-
162); the Application for Approval as Accreditation Body Under 42 CFR 
8.3(b) (Form SMA-163); and the Exception Request and Record of 
Justification Under 42 CFR 8.12 (Form SMA-168), which may be used on a 
voluntary basis by physicians when there is a patient care situation in 
which the physician must make a treatment decision that differs from 
the treatment regimen required by the regulation. Form SMA-168 is a 
simplified, standardized form to facilitate the documentation, request, 
and approval process for exceptions.
    SAMHSA believes that the recordkeeping requirements in the 
regulation are customary and usual practices within the medical and 
rehabilitative communities and has not calculated a response burden for 
them. The recordkeeping requirements set forth in 42 CFR 8.4, 8.11 and 
8.12 include maintenance of the following: 5-year retention by 
accreditation bodies of certain records pertaining to accreditation; 
documentation by an OTP of the following: A patient's medical 
examination when admitted to treatment, a patient's history, a 
treatment plan, any prenatal support provided the patient, 
justification of unusually large initial doses, changes in a patient's 
dosage schedule, justification of unusually large daily doses, the 
rationale for decreasing a patient's clinic attendance, and 
documentation of physiologic dependence.
    The table that follows summarizes the annual reporting burden 
associated with the regulation, including burden associated with the 
forms. There are no changes being made to the forms.

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                                     Number of      Responses/         Total          Hours/
              Form                  respondents     respondent       responses       response       Total hours
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                     Estimated Annual Reporting Requirement Burden for Accreditation Bodies
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SMA-163.........................              54          26.055           1,407            0.28             394
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                   Estimated Annual Reporting Requirement Burden for Opioid Treatment Programs
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SMA-162.........................          651.33          17.976       11,708.91  ..............  ..............
SMA-168.........................        1,302.67          17.977       23,418.09  ..............  ..............
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    Subtotal....................            1954          17.977          35,127            0.08            2902
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        Total...................  ..............  ..............          36,534  ..............            3296
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[[Page 55855]]

    Written 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.

Carlos Graham,
Reports Clearance Officer.
[FR Doc. 2021-21963 Filed 10-6-21; 8:45 am]
BILLING CODE 4162-20-P