Notice2022-18801
Agency Information Collection Activities: Proposed Collection; 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
August 31, 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 168 (Wednesday, August 31, 2022)</title>
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[Federal Register Volume 87, Number 168 (Wednesday, August 31, 2022)]
[Notices]
[Pages 53480-53482]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[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.
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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 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.
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Sub Total................. ................ 5,431 .............. .............. 5,112
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Total Burden.......... ................ 6,561 .............. .............. 6,647
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Send comments to Carlos Graham, SAMHSA Reports Clearance Officer,
5600 Fishers Lane, Room 15E57-A, Rockville, Maryland 20857, OR email a
copy to <a href="/cdn-cgi/l/email-protection#672406150b0814492015060f060a2714060a0f1406490f0f1449000811"><span class="__cf_email__" data-cfemail="c281a3b0aeadb1ec85b0a3aaa3af82b1a3afaab1a3ecaaaab1eca5adb4">[email protected]</span></a>. 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]
BILLING CODE 4162-20-P
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