[Federal Register Volume 87, Number 212 (Thursday, November 3, 2022)]
[Notices]
[Pages 66317-66318]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-23953]


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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: Notification of Intent To Use Schedule III, IV, or V 
Controlled Medications for the Treatment of Opioid Use Disorder Under 
21 U.S.C. 823(g)(2) (OMB No. 0930-0234 and OMB No. 0930-0369)--Revision

    The Drug Addiction Treatment Act of 2000 (``DATA,'' Pub. L. 106-
310) amended the Controlled Substances Act (21 U.S.C. 823(g)(2)) to 
permit qualifying practitioners to seek and obtain waivers to prescribe 
certain approved controlled medications for the treatment of opioid use 
disorder. The legislation set eligibility and certification 
requirements as well as an interagency notification review process for 
practitioners who seek waivers. To implement these provisions, SAMHSA 
developed Notification of Intent Forms that facilitate the submission 
and review of notifications. The forms provide the information 
necessary to determine whether practitioners meet the qualifications 
for waivers set forth under the law at the 30-, 100-, and 275-patient 
limits. This includes the annual reporting requirements for 
practitioners with waivers for a 275-patient limit. On October 24, 
2018, the Substance Use Disorder Prevention that Promotes Opioid 
Recovery and Treatment for Patients and Communities (SUPPORT) Act (Pub. 
L. 115-71) was signed into law. Sections 3201-3202 of the SUPPORT Act 
made several amendments to the Controlled Substances Act regarding 
office-based opioid use disorder treatment that affords practitioners 
greater flexibility in the provision of Medications for Opioid Use 
Disorder (MOUD).
    The SUPPORT Act expands the definition of ``qualifying other 
practitioner'' enabling Clinical Nurse Specialists, Certified 
Registered Nurse Anesthetists, and Certified Nurse Midwives (CNSs, 
CRNAs, and CNMs) to apply for a Drug Addiction Treatment Act of 2000 
(DATA) waiver until October 1, 2023. It also allows qualified 
practitioners (i.e., MDs, DOs, NPs, PAs, CNSs, CRNAs, and CNMs) who are 
board certified in addiction medicine or addiction psychiatry, -or- 
practitioners who provide MOUD in a qualified practice setting, to 
start treating up to 100 patients in the first year of practice (as 
defined in 42 CFR 8.2) with a waiver. Further, the SUPPORT Act extends 
the ability to treat up to 275 patients to ``qualifying other 
practitioners'' (i.e., NPs, PAs, CNSs, CRNAs, and CNMs) if they have a 
waiver to treat up 100 patients for at least one year and provide 
treatment of Opioid Use Disorder with covered medications (as such 
terms are defined under 42 CFR 8.2) in a qualified practice setting as 
described under 42 CFR 8.615. Finally, the SUPPORT Act also expands how 
physicians could qualify for a waiver. Under the statute now, 
physicians can qualify for a waiver if they have received at least 8 
hours of training on treating and managing patients with opioid use 
disorder, as listed in the statute if the physician graduated in good 
standing from an accredited school of allopathic medicine or 
osteopathic medicine in the United States during the 5-year period 
immediately preceding the date on which the physician submits a Notice 
of Intent to SAMHSA. In order to expedite the new provisions of the 
SUPPORT Act, SAMHSA sought and received a Public Health Emergency 
Paperwork Reduction Act Waiver.
    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. The Practice Guidelines allow practitioners who wish 
to obtain a 30-patient waiver to forego the 8-hour training requirement 
for physicians and 24-hour training for other qualifying practitioners. 
Practitioners utilizing this training exemption are limited to treating 
no more than 30-patients at a time and time spent practicing under this 
exemption will not qualify the practitioner to qualify for a higher 
patient level. In addition, the new Practice Guidelines removed the 
requirement to provide counseling and other ancillary services (i.e., 
psychosocial services).
    The collection of information within the application is essential 
to the implementation of SAMHSA's mission to reduce the impact of 
substance use disorders on America's communities. Practitioners may use 
these forms for various types of notifications: (a) New

[[Page 66318]]

Notification to treat up to 30 patients; (b) New Notification, with the 
intent to immediately facilitate treatment of an individual (one) 
patient; (c) Second notification of need and intent to treat up to 100 
patients; (d) New notification to treat up to 100 patients, and (e) New 
notification to treat up to 275 patients. Under ``new'' notifications, 
practitioners make their initial waiver requests to SAMHSA. 
``Immediate'' notifications inform SAMHSA and the Attorney General of a 
practitioner's intent to prescribe immediately to facilitate the 
treatment of an individual (one) patient under 21 U.S.C. 
823(g)(2)(E)(ii). The form collects data on the following items: 
Practitioner name; state medical license number; medical specialty; and 
DEA registration number; address of primary practice location, 
telephone and fax numbers; email address; name and address of group 
practice; group practice employer identification number; names and DEA 
registration numbers of group practitioners; purpose of notification: 
new, immediate, or renewal; certification of qualifying criteria for 
treatment and management of patients with opioid use disorder; 
certification of capacity to provide directly or refer patients for 
appropriate counseling and other appropriate ancillary services; 
certification of maximum patient load, certification to use only those 
medication formulations that meet the criteria in the law. The form 
also notifies practitioners of Privacy Act considerations and permits 
practitioners to expressly consent to disclose limited information to 
the SAMHSA Buprenorphine Physician and Behavioral Health Treatment 
Services locators. The following table summarizes the estimated annual 
burden for the use of these forms.

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                                                     Estimated
        42 CFR citation            Purpose of        number of      Responses/        Burden/      Total burden
                                   submission       respondents     respondent    response (hr.)      (hrs.)
----------------------------------------------------------------------------------------------------------------
                                Notification of            1,800               1           0.083             149
                                 Intent.
                                Notification to               60               1           0.083               5
                                 Prescribe
                                 Immediately.
                                Notice to Treat              600               1            0.04              24
                                 up to 100
                                 patients.
                                Notice to Treat              960               1           0.081              78
                                 up to 275
                                 patients.
                                                 ---------------------------------------------------------------
    Subtotal..................  ................           3,420  ..............  ..............             256
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                     Burden Associated With the Final Rule That Increased the Patient Limit
----------------------------------------------------------------------------------------------------------------
8.620 (a)-(c).................  Request for                  620               1             0.5             310
                                 Patient Limit
                                 Increase *.
                                Request for                  620               1             0.5             310
                                 Patient Limit
                                 Increase *.
                                Request for                  620               1             0.5             310
                                 Patient Limit
                                 Increase *.
8.64..........................  Renewal Request              312               1             0.5             156
                                 for a Patient
                                 Limit Increase
                                 *.
                                Renewal Request              312               1             0.5             156
                                 for a Patient
                                 Limit Increase
                                 *.
                                Renewal Request              312               1             0.5             156
                                 for a Patient
                                 Limit Increase
                                 *.
8.655.........................  Request for a                 12               1               3              36
                                 Temporary
                                 Patient
                                 Increase for an
                                 Emergency *.
                                Request for a                 12               1               3              36
                                 Temporary
                                 Patient
                                 Increase for an
                                 Emergency *.
                                Request for a                 12               1               3              36
                                 Temporary
                                 Patient
                                 Increase for an
                                 Emergency *.
                                                 ---------------------------------------------------------------
    Subtotal..................  ................           2,497  ..............  ..............           1,279
----------------------------------------------------------------------------------------------------------------
                 Burden Associated With the Final Rule That Outlined the Reporting Requirements
----------------------------------------------------------------------------------------------------------------
8.635.........................  Practitioner               1,620  ..............               3            4860
                                 Reporting Form
                                 *.
                                ``Qualifying                 979               1           0.066              65
                                 Other
                                 Practitioner''
                                 under 21 USC
                                 Sec.
                                 823(g)(2)--Nurs
                                 e Practitioners.
                                ``Qualifying                 708               1           0.066              47
                                 Other
                                 Practitioner''
                                 under 21 USC
                                 Sec.
                                 823(g)(2)--Phys
                                 ician
                                 Assistants.
                                ``Qualifying                 708               1           0.066              47
                                 Other
                                 Practitioner''
                                 under 21 USC
                                 Sec.
                                 823(g)(2)--Cert
                                 ified Nurse
                                 Specialists.
                                ``Qualifying                 708               1           0.066              47
                                 Other
                                 Practitioner''
                                 under 21 USC
                                 Sec.
                                 823(g)(2)--Cert
                                 ified Nurse Mid-
                                 Wives.
                                ``Qualifying                 708               1           0.066              47
                                 Other
                                 Practitioner''
                                 under 21 USC
                                 Sec.
                                 823(g)(2)--Cert
                                 ified
                                 Registered
                                 Nurse
                                 Anesthetists.
                                                 ---------------------------------------------------------------
    Sub Total.................  ................           5,431               1  ..............            5112
                                                 ---------------------------------------------------------------
        Total Burden..........  ................           6,561  ..............  ..............           6,647
----------------------------------------------------------------------------------------------------------------

    Written comments and recommendations for the proposed information 
collection should be sent within 30 days of publication of this notice 
to www.reginfo.gov/public/do/PRAMain. Find this particular information 
collection by selecting ``Currently under 30-day Review--Open for 
Public Comments'' or by using the search function.

Alicia Broadus,
Public Health Advisor.
[FR Doc. 2022-23953 Filed 11-2-22; 8:45 am]
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