0930-0234 NOI _ No Material or Nonsubstantive Change_5-26-2021

Notification of Intent to Use Schedule III, IV, or V Opioid Drugs for the Maintenance and Detoxification Treatment of Opiate Addiction

No Material or Nonsubstantive Change Justification

The Substance Abuse and Mental Health Services Administration (SAMHSA) is requesting a no material or nonsubstantive change approval from the Office of Management and Budget (OMB) for (OMB No. 0930-0234) Notification of Intent (NOI) to Use Schedule III, IV, or V Opioid Drugs for the Maintenance and Detoxification Treatment of Opiate Addiction. This data collection expires on January 31, 2023. There are currently four forms approved under OMB No. 0930-0234: (1) Notice of Intent (NOI) Physicians for 30 and 100 Patient Limit; and (2) NOI Qualifying Other Practitioners for 30 and 100 Patient Limit; and (3) NOI 275 Patient Limit for all Qualifying Practitioners; and (4) Practitioner Reporting Form.

SAMHSA is requesting changes to two of the four approved documents. It is requesting to make no material or nonsubstantive changes to the Physicians for 30 and 100 patient limit and Qualifying Other Practitioners for 30 and 100 patient limit forms. On April 28, 2021 the Department of Health and Human Services (HHS) issued the new Practice Guidelines for the Administration of Buprenorphine for Treating Opioid Use Disorder (86 FR 22439) in an expedited manner, which prevented SAMHSA from pursuing the normal Paperwork Reduction Act (PRA) process. This data collection is essential to the implementation of SAMHSA’s mission to reduce the impact of substance use disorders on America's communities.

SAMHSA is requesting approval for the additional text to section 8 “CERTIFICATION OF QUALIFYING CRITERIA” to both the NOI Physicians for 30 and 100 Patient Limit and the NOI Qualifying Other Practitioners for 30 and 100 Patient Limit forms:

SAMHSA/HHS Buprenorphine practice guideline exemption (April 2021). These practice guidelines exempt covered practitioners licensed under state law, and who possess a valid DEA registration, from certification requirements related to training, counseling, and other ancillary services (i.e., direct provision of or referral to psychosocial services).

This exemption only applies to those treating up to 30 patients. Time spent practicing under this exemption will not qualify the practitioner for a higher patient limit.

The above text will be red in the online form. If practitioners select this option, skip logic programmed in the online form will remove the options for practitioners to provide information related to training, counseling, and other ancillary services (i.e., direct provision of or referral to psychosocial services).

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