Notice2021-21963
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
October 7, 2021
Issuing agencies
Health and Human Services DepartmentSubstance Abuse and Mental Health Services Administration
Full Text
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<title>Federal Register, Volume 86 Issue 192 (Thursday, October 7, 2021)</title>
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[Federal Register Volume 86, Number 192 (Thursday, October 7, 2021)]
[Notices]
[Pages 55854-55855]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[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 <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.
Carlos Graham,
Reports Clearance Officer.
[FR Doc. 2021-21963 Filed 10-6-21; 8:45 am]
BILLING CODE 4162-20-P
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</html>Indexed from Federal Register on October 7, 2021.
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.