[Federal Register Volume 89, Number 108 (Tuesday, June 4, 2024)]
[Notices]
[Pages 47973-47974]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-12197]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Substance Abuse and Mental Health Services Administration


Agency Information Collection Activities: Proposed Collection; 
Comment Request

    In compliance with Section 3506(c)(2)(A) of the Paperwork Reduction 
Act of 1995 concerning opportunity for public comment on proposed 
collections of information, the Substance Abuse and Mental Health 
Services Administration (SAMHSA) will publish periodic summaries of 
proposed projects. To request more information on the proposed projects 
or to obtain a copy of the information collection plans, call the 
SAMHSA Reports Clearance Officer on (240) 276-0361.
    Comments are invited on: (a) whether the proposed collections of 
information are 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; and (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.

Project: Medications for the Treatment of Opioid Use Disorder--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 use disorder treatment under the federal 
opioid use disorder 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, medical care, 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 Medications for the Treatment of Opioid Use Disorder 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 OTP 
practitioners when there is a patient care situation in which the OTP 
practitioner must make a treatment decision that falls outside of the 
required standards delineated in 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 medical history, a 
care plan, any prenatal support provided the patient if applicable, the 
medical rationale for initial starting doses above 50mg, the medical 
rationale for a patient's dosage schedule, and care decisions made as a 
result of follow-up medical examinations.
    The tables that follow summarizes the annual reporting burden 
associated with the regulation, including burden associated with the 
forms. There are minor changes to these forms to improve data 
collection, remove unnecessary questions, and align terms with the 
final 42 CFR part 8 rule released February 2, 2024.

[[Page 47974]]



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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.........................          751.33          17.976          13,506            0.08           1,081
SMA-168.........................        1,302.67          17.977          23,418            0.08           1,873
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    Subtotal....................           2,054          17.977          36,925            0.08           2,954
        Total...................  ..............  ..............          38,332  ..............           3,348
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    Send comments to SAMHSA Reports Clearance Officer, 5600 Fisher 
Lane, Room 15E45, Rockville, MD 20852 OR email a copy to 
[email protected]. Written comments should be received by August 
5, 2024.

Alicia Broadus,
Public Health Advisor.
[FR Doc. 2024-12197 Filed 6-3-24; 8:45 am]
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