[Federal Register Volume 89, Number 153 (Thursday, August 8, 2024)]
[Notices]
[Pages 64942-64943]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-17647]


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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: Medications for the Treatment of Opioid Use Disorder--42 CFR 
Part 8 (OMB No. 0930-0206) and Opioid Treatment Programs (OTPs)--
Revision

    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, 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 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 8.11(h) 
(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 
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 table that follows 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.

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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
Subtotal........................           2,054          17.977          36,925            0.08           2,954
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    Total.......................  ..............  ..............          38,332  ..............           3,348
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[[Page 64943]]

    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.

Alicia Broadus,
Public Health Advisor.
[FR Doc. 2024-17647 Filed 8-7-24; 8:45 am]
BILLING CODE 4162-20-P