Notice2024-12197
Agency Information Collection Activities: Proposed Collection; 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
June 4, 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 108 (Tuesday, June 4, 2024)</title>
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[Federal Register Volume 89, Number 108 (Tuesday, June 4, 2024)]
[Notices]
[Pages 47973-47974]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[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
<a href="/cdn-cgi/l/email-protection#4033212d2833213032210033212d2833216e2828336e272f36"><span class="__cf_email__" data-cfemail="4f3c2e22273c2e3f3d2e0f3c2e22273c2e6127273c61282039">[email protected]</span></a>. 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]
BILLING CODE 4162-20-P
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