Notice2022-23953
Agency Information Collection Activities: Submission for OMB Review; Comment Request
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
November 3, 2022
Issuing agencies
Health and Human Services DepartmentSubstance Abuse and Mental Health Services Administration
Full Text
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<title>Federal Register, Volume 87 Issue 212 (Thursday, November 3, 2022)</title>
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[Federal Register Volume 87, Number 212 (Thursday, November 3, 2022)]
[Notices]
[Pages 66317-66318]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[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.)
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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.
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Subtotal.................. ................ 3,420 .............. .............. 256
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Burden Associated With the Final Rule That Increased the Patient Limit
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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 *.
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Subtotal.................. ................ 2,497 .............. .............. 1,279
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Burden Associated With the Final Rule That Outlined the Reporting Requirements
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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.
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Sub Total................. ................ 5,431 1 .............. 5112
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Total Burden.......... ................ 6,561 .............. .............. 6,647
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Written comments and recommendations for the proposed information
collection should be sent within 30 days of publication of this notice
to <a href="http://www.reginfo.gov/public/do/PRAMain">www.reginfo.gov/public/do/PRAMain</a>. 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]
BILLING CODE 4162-20-P
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</html>Indexed from Federal Register on November 3, 2022.
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