[Federal Register Volume 87, Number 168 (Wednesday, August 31, 2022)]
[Notices]
[Pages 53480-53482]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-18801]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Substance Abuse and Mental Health Services Administration


Agency Information Collection Activities: Proposed Collection; 
Comment Request

    In compliance with Section 3506(c)(2)(A) of the Paperwork Reduction 
Act of 1995 concerning opportunity for public comment on proposed 
collections of information, the Substance Abuse and Mental Health 
Services Administration (SAMHSA) will publish periodic summaries of 
proposed projects. To request more information on the proposed projects 
or to obtain a copy of the information collection plans, call the 
SAMHSA Reports Clearance Officer on (240) 276-0361.
    Comments are invited on: (a) whether the proposed collections of 
information are necessary for the proper performance of the functions 
of the agency, including whether the information shall have practical 
utility; (b) the accuracy of the agency's estimate of the burden of the 
proposed collection of information; (c) ways to enhance the quality, 
utility, and clarity of the information to be collected; and (d) ways 
to minimize the burden of the collection of information on respondents, 
including through the use of automated collection techniques or other 
forms of information technology.

Proposed 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.
    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. 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 MOUD

[[Page 53481]]

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 MOUD 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 new 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 Notification to 
treat up to 30 patients with training or without training; (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. The 
forms provide the information necessary to determine whether 
practitioners meet the qualifications for waivers set forth under the 
law at the 30E-, 30-, 100-, 275E-, and 275-patient limits. This 
includes the annual reporting requirements for practitioners with 
waivers for a 275-patient limit.
    Under ``new'' notifications, practitioners may 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; 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, as applicable; 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 this form.

----------------------------------------------------------------------------------------------------------------
                                                     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
----------------------------------------------------------------------------------------------------------------
                     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               1               3           4,860
                                 Reporting Form
                                 *.
                                ``Qualifying                 979               1           0.066              65
                                 Other
                                 Practitioner''
                                 under 21 USC
                                 Sec.
                                 823(g)(2)--Nurs
                                 e Practitioners.

[[Page 53482]]

 
                                ``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  ..............  ..............           5,112
                                                 ---------------------------------------------------------------
        Total Burden..........  ................           6,561  ..............  ..............           6,647
----------------------------------------------------------------------------------------------------------------

    Send comments to Carlos Graham, SAMHSA Reports Clearance Officer, 
5600 Fishers Lane, Room 15E57-A, Rockville, Maryland 20857, OR email a 
copy to [email protected]. Written comments should be 
received by October 31, 2022.

Carlos Graham,
Reports Clearance Officer.
[FR Doc. 2022-18801 Filed 8-30-22; 8:45 am]
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