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HHS/SAMHSA RIN: 0930-AA39 Publication ID: Fall 2023 
Title: Medications for the Treatment of Opioid Use Disorder 

The Substance Abuse and Mental Health Services Administration (SAMHSA) will revise 42 CFR part 8 to make permanent some regulatory flexibilities for Opioid Treatment Programs (OTPs) granted under the COVID-19 Public Health Emergency (PHE), and to expand access to care for people with Opioid Use Disorder (OUD). Specifically, SAMHSA will update criteria pertaining to unsupervised doses of methadone and also initiation of buprenorphine via telemedicine. To expand access to care, SAMHSA will also update admission criteria, particularly those rules that may limit timely access to treatment in an OTP. To achieve this, sections of 42 CFR part 8 will require updating. SAMHSA’s changes will impact roughly 1900 opioid treatment programs and state opioid treatment authorities.

In response to the Consolidated Appropriations Act of 2023, which removed the requirement to obtain a waiver in order to prescribe certain schedule III-V medications for the treatment of OUD, SAMHSA issued a supplemental notice of proposed rulemaking on Feb. 13, 2023, (88 FR 9221) calling for additional public comment on SAMHSA’s plans to remove reference to the Drug Addiction Treatment Act of 2000 ( DATA  2000-Waiver) from 42 CFR part 8.

Agency: Department of Health and Human Services(HHS)  Priority: Other Significant 
RIN Status: Previously published in the Unified Agenda Agenda Stage of Rulemaking: Final Rule Stage 
Major: Yes  Unfunded Mandates: No 
CFR Citation: 42 CFR 8   
Legal Authority: 21 U.S.C. sec. 823(g)(1)   
Legal Deadline:  None
Action Date FR Cite
NPRM  12/16/2022  87 FR 77330   
Supplemental NPRM  02/13/2023  88 FR 9221   
NPRM Comment Period End  02/14/2023 
Supplemental NPRM Comment Period End  03/14/2023 
Final Action  01/00/2024 
Regulatory Flexibility Analysis Required: Yes  Government Levels Affected: State 
Small Entities Affected: Businesses  Federalism: No 
Included in the Regulatory Plan: No 
RIN Data Printed in the FR: Yes 
Agency Contact:
Dr. Neeraj Gandotra
Chief Medical Officer
Department of Health and Human Services
Substance Abuse and Mental Health Services Administration
5600 Fishers Lane, 18E67,
Rockville, MD 20857
Phone:202 823-1816