HHS Opioid Use Disorder Medications Correction

Content

ACTION:

Correcting amendment.

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This document corrects two outdated references that should have been deleted and one outdated reference in the final rule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 Robert.Baillieu@samhsa.hhs.gov, 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there were two outdated references that should have been deleted and one outdated reference that is in this correcting document.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 HHS is revising the section to replace the outdated text with the correct references.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

  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

Regulatory Text 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.

1. Amend § 8.3 by revising paragraph (b) to read as follows:

§ 8.3 Application for approval as an Accreditation Body.

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(b) Application for initial approval. Electronic copies of an Accreditation Body application form [SMA-163] shall be submitted to: https://dpt2.samhsa.gov/sma163/.

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1. Amend § 8.11 by revising paragraphs (a)(1) and (5) and (c)(3) to read as follows:

§ 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.

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(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 § 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.

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(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.

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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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