Rule2026-03577
Medications for the Treatment of Opioid Use Disorder; Correction
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
February 23, 2026
Effective
February 23, 2026
Issuing agencies
Health and Human Services Department
Abstract
This document corrects two outdated references that should have been deleted and one outdated reference in the final rule that appeared in the February 2, 2024 Federal Register titled "Medications for the Treatment of Opioid Use Disorder," specifying final modified and updated certain provisions related to Opioid Treatment Program (OTP) accreditation, certification, and standards for the treatment of Opioid Use Disorder with Medications for Opioid Use Disorders in OTPs. The effective date of the final rule was April 2, 2024, and the compliance date was October 2, 2024.
Full Text
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<title>Federal Register, Volume 91 Issue 35 (Monday, February 23, 2026)</title>
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[Federal Register Volume 91, Number 35 (Monday, February 23, 2026)]
[Rules and Regulations]
[Pages 8381-8382]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2026-03577]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Office of the Secretary
42 CFR Part 8
RIN 0930-AA39
Medications for the Treatment of Opioid Use Disorder; Correction
AGENCY: Substance Abuse and Mental Health Services Administration
(SAMHSA), Department of Health and Human Services (HHS).
ACTION: Correcting amendment.
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SUMMARY: This document corrects two outdated references that should
have been deleted and one outdated reference in the final rule that
appeared in the February 2, 2024 Federal Register titled ``Medications
for the Treatment of Opioid Use Disorder,'' specifying final modified
and updated certain provisions related to Opioid Treatment Program
(OTP) accreditation, certification, and standards for the treatment of
Opioid Use Disorder with Medications for Opioid Use Disorders in OTPs.
The effective date of the final rule was April 2, 2024, and the
compliance date was October 2, 2024.
DATES: Effective on February 23, 2026.
FOR FURTHER INFORMATION CONTACT: Robert Baillieu, MD, DHSc, MPH, (240)
276-1244, or <a href="/cdn-cgi/l/email-protection#d486bbb6b1a6a0fa96b5bdb8b8bdb1a194a7b5b9bca7b5fabcbca7fab3bba2"><span class="__cf_email__" data-cfemail="9ac8f5f8ffe8eeb4d8fbf3f6f6f3ffefdae9fbf7f2e9fbb4f2f2e9b4fdf5ec">[email protected]</span></a>, Center Substance Abuse
Treatment.
SUPPLEMENTARY INFORMATION:
I. Background
In FR Doc. 2024-01693 of February 2, 2024, the Medications for the
Treatment of Opioid Use Disorder final rule (89 FR 7528), there were
two outdated references that should have been deleted and one outdated
reference that is in this correcting document.
II. Summary of Errors
Section 8.3(b) of the regulation erroneously references
Accreditation Body application form SMA-167. HHS is correcting the text
to reference form SMA-163.
Section 8.11 of the regulation currently links to section 303(g)(1)
of the Controlled Substances Act instead of section 303(h), which is
the correct reference, and to 42 CFR 8.4(b)(1)(iii), a section which
does not exist in the final rule, instead of 42 CFR 8.4(b). HHS is
revising the section to replace the outdated text with the correct
references.
Publication of this document constitutes final action on these
changes under the Administrative Procedure Act (APA) (5 U.S.C. 553).
The APA generally exempts rules from the requirements of notice and
comment rulemaking when an agency ``for good cause finds (and
incorporates the finding and a brief statement of reasons therefor in
the rules issued) that notice and public procedure thereon are
impracticable, unnecessary, or contrary to the public interest'' (5
U.S.C. 553(b)(B)).
HHS has determined that notice and public comment are unnecessary
because this amendment to the regulation provides only technical or
non-substantive changes to specify the location of cross-referenced
regulations currently in effect. Such technical, non-substantive
changes are ``routine determination[s], insignificant in nature and
impact, and inconsequential to the industry and to the public.'' (Mack
Trucks, Inc. v. EPA, 682 F.3d 87, 94 (D.C. Cir. 2012)) (quotation marks
and citation omitted). Accordingly, HHS for good cause finds that
notice and public procedure thereon are unnecessary for changing this
regulation.
In addition, HHS finds good cause for these amendments to become
effective on the date of publication of this action. The APA allows an
effective date of less than 30 days after publication as ``provided by
the agency for good cause found and published with the rule'' (5 U.S.C.
553(d)(3)). A delayed effective date is unnecessary in this case
because the amendments do not impose any new regulatory requirements on
affected parties, and affected parties do not need
[[Page 8382]]
time to ``adjust to the new regulation'' before the rule takes effect.
(Am. Federation of Government Emp., AFL-CIO v. Block, 655 F.2d 1153,
1156 (D.C. Cir. 1981). Therefore, HHS finds good cause for these
amendments to become effective on the date of publication of this
action.
III. Waiver of Proposed Rulemaking
Section 1871(b)(1) of the Social Security Act (the Act) requires
the Secretary to provide for notice of a proposed rule in the Federal
Register and provide a period of not less than 60 days for public
comment. In addition, section 1871(e)(1)(B)(i) of the Act mandates a
30-day delay in effective date after issuance or publication of a rule.
Section 1871(b)(2)(C) of the Act provides an exception from the notice
and 60-day comment period and delay in effective date requirements of
the Act, under the good cause standard set forth in 5 U.S.C. 553(b)(B).
Section 1871(e)(1)(B)(ii) of the Act provides an exception from the
delay in effective date requirements of the Act as well. Section
553(b)(B) authorizes an agency to dispense with normal notice and
comment rulemaking procedures for good cause if the agency makes a
finding that the notice and comment process is impracticable,
unnecessary, or contrary to the public interest, and includes a
statement of the finding and the reasons for it in the rule. In
addition, section 1871(e)(1)(B)(ii) of the Act allows the agency to
avoid the 30-day delay in effective date where the waiver is necessary
to comply with statutory requirements, or such delay is contrary to the
public interest and the agency includes in the rule a statement of the
finding and the reasons for it.
In our view, this correcting document does not constitute a
rulemaking that would be subject to these requirements. This document
merely corrects typographical errors in the Medications for the
Treatment of Opioid Use Disorder final rule. The corrections contained
in this document are consistent with, and do not make substantive
changes to, the policies and payment methodologies that were proposed,
subject to notice and comment procedures, and adopted in the
Medications for the Treatment of Opioid Use Disorder final rule. As a
result, the corrections made through this document are intended to
resolve inadvertent errors so that the Medications for the Treatment of
Opioid Use Disorder final rule accurately reflects the policies adopted
therein.
In addition, even if this were a rulemaking to which the notice and
comment and delayed effective date requirements applied, we find that
there is good cause to waive such requirements. Undertaking further
notice and comment procedures to incorporate the corrections in this
document into the Medications for the Treatment of Opioid Use Disorder
final rule or delaying the effective date of the corrections are
unnecessary because we are not making any substantive revisions to the
Medications for the Treatment of Opioid Use Disorder final rule, but
rather, we are simply correcting the Code of Federal Regulations to
reflect the policies that we previously proposed, received public
comment on, and subsequently finalized in the Medications for the
Treatment of Opioid Use Disorder final rule. Further comment is not
needed to inform our decision to rectify the ministerial errors noted
in this final rule and correction. For these reasons, we believe there
is good cause to waive notice and comment and delay in effective date,
even if they were required.
List of Subjects in 42 CFR Part 8
Administrative practice and procedure, Health professions,
Methadone, Reporting and recordkeeping requirements, Substance misuse.
Accordingly, 42 CFR part 8 is corrected by making the following
correcting amendments:
PART 8--MEDICATIONS FOR THE TREATMENT OF OPIOID USE DISORDER
0
1. The authority citation for part 8 continues to read as follows:
Authority: 21 U.S.C. 823; 42 U.S.C. 257a, 290aa(d), 290dd-2,
300x-23, 300x-27(a), 300y-11.
0
2. Amend Sec. 8.3 by revising paragraph (b) to read as follows:
Sec. 8.3 Application for approval as an Accreditation Body.
* * * * *
(b) Application for initial approval. Electronic copies of an
Accreditation Body application form [SMA-163] shall be submitted to:
<a href="https://dpt2.samhsa.gov/sma163/">https://dpt2.samhsa.gov/sma163/</a>.
* * * * *
0
3. Amend Sec. 8.11 by revising paragraphs (a)(1) and (5) and (c)(3) to
read as follows:
Sec. 8.11 Opioid Treatment Program certification.
(a) * * *
(1) An OTP must be the subject of a current, valid certification
from the Secretary to be considered qualified by the Secretary under
section 303(h) of the Controlled Substances Act (21 U.S.C. 823(h)(1))
to dispense MOUD in the treatment of OUD. An OTP must be determined to
be qualified under section 303(h) of the Controlled Substances Act and
must be determined to be qualified by the Attorney General under
section 303(h), to be registered by the Attorney General to dispense
MOUD to individuals for treatment of OUD.
* * * * *
(5) OTPs that are certified and are seeking certification renewal,
and who have been granted accreditation for 1 year by an Accreditation
Body as provided under Sec. 8.4(b), may receive a conditional
certification for one year unless the Secretary determines that such
conditional certification would adversely affect patient health. An OTP
must obtain a standard 3-year certification, as described in paragraph
(a)(3) of this section, within the 1-year conditional certification
period. If standard accreditation is not obtained by the OTP within the
1-year conditional certification period, the OTP's conditional
certification will lapse, and the Attorney General will be notified
that the OTP's registration should be revoked.
* * * * *
(c) * * *
(3) Within 5 days after it reaches a final determination that an
OTP meets the requirements for certification in this section; the
Secretary will notify the Drug Enforcement Administration that the OTP
has been determined to be qualified to provide OUD treatment under
section 303(h) of the Controlled Substances Act.
* * * * *
Robert F. Kennedy, Jr.,
Secretary, Department of Health and Human Services.
[FR Doc. 2026-03577 Filed 2-20-26; 8:45 am]
BILLING CODE 4162-20-P
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