[Federal Register Volume 82, Number 52 (Monday, March 20, 2017)]
[Notices]
[Pages 14372-14373]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-05419]
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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) 276-1243.
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
Opioid Drugs for the Maintenance and Detoxification Treatment of Opiate
Addiction by a ``Qualifying Other Practitioner''--(OMB No. 0930-0369)--
Revision
The Substance Abuse and Mental Health Services Administration
(SAMHSA) is requesting a revision from the Office of Management and
Budget (OMB) for approval of the Notification of Intent to Use Schedule
III, IV, or V Opioid Drugs for the Maintenance and Detoxification
Treatment of Opiate Addiction by a ``Qualifying Other Practitioner. The
Notification of Intent would allow SAMHSA to determine whether other
practitioners are eligible to prescribe certain approved narcotic
treatment medications for the maintenance or detoxification treatment
of opioid addiction.
This Notification of Intent is a result of the Comprehensive
Addiction and Recovery Act (Pub. L. 114-198), which was signed into law
on July 22, 2016. The law establishes criteria for nurse practitioners
(NPs) and physician assistants (PAs) to qualify for a waiver to
prescribe covered medications. To be eligible for a waiver, the NP or
PA must: Be licensed under State law to prescribe schedule III, IV, or
V medications for the treatment of pain; fulfill qualification
requirements in the law for training and experience; and fulfill
qualification requirements in the law for appropriate supervision by a
qualifying physician. SAMHSA has the responsibility to receive, review,
approve, or deny waiver requests.
Practitioners who meet the statutory requirements will be eligible
to prescribe only those opioid treatment medications that are
controlled in Schedules III, IV, or V, under the
[[Page 14373]]
Controlled Substance Act (CSA), that are specifically approved by the
Food and Drug Administration (FDA) for the treatment of opioid
addiction, and are not the subject of an ``adverse determination.'' The
only medications that currently fulfill these requirements are ones
that contain the active ingredient buprenorphine.
Below are the following changes:
Use of Term of ``Qualifying Practitioners'' (NOI Sections 1, 2, 6, and
11)
The Statute Section 823(g)(2)(B)(i) refers to both physicians and
mid-level providers as ``qualifying practitioners.'' Therefore in order
to avoid confusion and redundancy, the revised NOI refers to ``other
qualifying practitioners,'' simply as ``practitioners''.
Patient Limits (See NOI Section 6: Purpose of Notification)
Language was added allowing practitioners who have treated 30
patients for at least one year to increase their patient limit to 100.
This second notification to treat 100 patients was omitted in the
original NOI form.
Identification of Training Providers
The previous NOI required that the practitioner to write in the
name of training provider(s)' name(s). The revised NOI allows
practitioners to select training providers from a list.
The following table is the estimated hour burden:
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Number of Responses/ Total burden
Purpose of submission respondents respondent Burden hours hours
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Notification of Intent for Qualifying Other 816 1 .066 54
Practitioner to Use Schedule III, IV, or V
Opioid Drugs for the Maintenance and
Detoxification Treatment of Opiate Addiction by
a ``Qualifying Other Practitioner'' under 21
USC Sec. 823(g)(2)--Nurse Practitioners......
Notification of Intent for Qualifying Other 590 1 .066 39
Practitioner to Use Schedule III, IV, or V
Opioid Drugs for the Maintenance and
Detoxification Treatment of Opiate Addiction by
a ``Qualifying Other Practitioner'' under 21
USC Sec. 823(g)(2)--Physician Assistants.....
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Total....................................... 1,406 .............. .............. 93
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Send comments to Summer King, SAMHSA Reports Clearance Officer,
5600 Fishers Lane, Room 15E57-B, Rockville, Maryland 20857, OR email a
copy to [email protected]. Written comments should be received
by May 19, 2017.
Summer King,
Statistician.
[FR Doc. 2017-05419 Filed 3-17-17; 8:45 am]
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