[Federal Register Volume 84, Number 232 (Tuesday, December 3, 2019)]
[Notices]
[Pages 66211-66213]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-26001]
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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) 276-1243.
Project: Notification of Intent To Use Schedule III, IV, or V Opioid
Drugs for the Maintenance and Detoxification Treatment of Opiate
Addiction 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 narcotic treatment drugs for the treatment of opiate
addiction. The legislation set eligibility requirements 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
meets the qualifications for waivers set forth under the law at the
[[Page 66212]]
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 treatment that affords practitioners
greater flexibility in the provision of medication-assisted treatment
(MAT).
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 MAT in a qualified practice setting, to start
treating up to 100 patients in the first year of MAT 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 medication-assisted treatment 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 opiate-dependent
patients, 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 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. Practitioners may use the form for four types of
notifications: (a) New 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; and (d) New notification to treat up to 100
patients. 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; 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 opiate dependent
patients; 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 drug products 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 Burden/
42 CFR citation Purpose of number of Responses/ response Total burden
submission respondents respondent (hrs.) (hrs.)
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Notification of 1,500 1 0.083 125
Intent.
Notification to 50 1 0.083 4
Prescribe
Immediately.
Notice to Treat up 500 1 0.04 20
to 100 patients.
Notice to Treat up 800 1 1 65
to 275 patients.
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Subtotal......... 2,850 .............. .............. 214
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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 Patient 517 1 0.5 259
Limit Increase *.
Request for Patient 517 1 0.5 259
Limit Increase *.
Request for Patient 517 1 0.5 259
Limit Increase *.
8.64...................... Renewal Request for 260 1 0.5 130
a Patient Limit
Increase *.
Renewal Request for 260 1 0.5 130
a Patient Limit
Increase *.
Renewal Request for 260 1 0.5 130
a Patient Limit
Increase*.
8.655..................... Request for a 10 1 3 30
Temporary Patient
Increase for an
Emergency *.
Request for a 10 1 3 30
Temporary Patient
Increase for an
Emergency *.
Request for a 10 1 3 30
Temporary Patient
Increase for an
Emergency *.
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Subtotal......... 2,361 .............. .............. 1,256
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New Burden Associated with the Final Rule That Outlined the Reporting Requirements
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8.635..................... Practitioner 1,350 1 3 4,050
Reporting Form *.
``Qualifying Other 816 1 0.066 54
Practitioner''
under 21 U.S.C.
823(g)(2)--Nurse
Practitioners.
[[Page 66213]]
``Qualifying Other 590 1 0.066 39
Practitioner''
under 21 U.S.C.
823(g)(2)--Physicia
n Assistants.
``Qualifying Other 590 1 0.066 39
Practitioner''
under 21 U.S.C.
823(g)(2)--Certifie
d Nurse Specialists.
``Qualifying Other 590 1 0.066 39
Practitioner''
under 21 U.S.C.
823(g)(2)--Certifie
d Nurse Mid-Wives.
``Qualifying Other 590 1 0.066 39
Practitioner''
under 21 U.SC.
823(g)(2)--Certifie
d Registered Nurse
Anesthetists.
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Subtotal......... 4,526 .............. .............. 4,260
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Total Burden... 6,561 .............. .............. 5,519
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Written comments and recommendations concerning the proposed
information collection should be sent by January 2, 2020 to the SAMHSA
Desk Officer at the Office of Information and Regulatory Affairs,
Office of Management and Budget (OMB). To ensure timely receipt of
comments, and to avoid potential delays in OMB's receipt and processing
of mail sent through the U.S. Postal Service, commenters are encouraged
to submit their comments to OMB via email to:
[email protected]. Although commenters are encouraged to send
their comments via email, commenters may also fax their comments to:
202-395-7285. Commenters may also mail them to: Office of Management
and Budget, Office of Information and Regulatory Affairs, New Executive
Office Building, Room 10102, Washington, DC 20503.
Summer King,
Statistician.
[FR Doc. 2019-26001 Filed 12-2-19; 8:45 am]
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