Notice2024-17647
Agency Information Collection Activities: Submission for OMB Review; Comment Request
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
August 8, 2024
Issuing agencies
Health and Human Services DepartmentSubstance Abuse and Mental Health Services Administration
Full Text
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<title>Federal Register, Volume 89 Issue 153 (Thursday, August 8, 2024)</title>
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[Federal Register Volume 89, Number 153 (Thursday, August 8, 2024)]
[Notices]
[Pages 64942-64943]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[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 <a href="http://www.reginfo.gov/public/do/PRAMain">www.reginfo.gov/public/do/PRAMain</a>. 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
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</html>Indexed from Federal Register on August 8, 2024.
This is legal information, not legal advice. Laws vary by jurisdiction and change frequently. Always verify current law with official sources and consult a licensed attorney in your jurisdiction for advice on your specific situation.