[Federal Register Volume 84, Number 191 (Wednesday, October 2, 2019)]
[Notices]
[Pages 52521-52522]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-21388]


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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 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 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.

[[Page 52522]]



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                                                                                             Estimated                        Burden/
                   42 CFR citation                           Purpose of submission           number of      Responses/       response      Total burden
                                                                                            respondents     respondent         (hr.)          (hrs.)
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                      Notification of Intent............           1,500               1           0.083             125
                                                      Notification to Prescribe                       50               1           0.083               4
                                                       Immediately.
                                                      Notice to Treat up to 100 patients             500               1            0.04              20
                                                      Notice to Treat up to 275 patients             800               1               1              65
                                                                                         ---------------------------------------------------------------
    Subtotal........................................  ..................................           2,850  ..............  ..............             214
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                                         Burden Associated with the Final Rule That Increased the Patient Limit
--------------------------------------------------------------------------------------------------------------------------------------------------------
8.620 (a)-(c).......................................  Request for Patient Limit Increase             517               1             0.5             259
                                                       *.
                                                      Request for Patient Limit Increase             517               1             0.5             259
                                                       *.
                                                      Request for Patient Limit Increase             517               1             0.5             259
                                                       *.
8.64................................................  Renewal Request for a Patient                  260               1             0.5             130
                                                       Limit Increase *.
                                                      Renewal Request for a Patient                  260               1             0.5             130
                                                       Limit Increase *.
                                                      Renewal Request for a Patient                  260               1             0.5             130
                                                       Limit Increase *.
8.655...............................................  Request for a Temporary Patient                 10               1               3              30
                                                       Increase for an Emergency *.
                                                      Request for a Temporary Patient                 10               1               3              30
                                                       Increase for an Emergency *.
                                                      Request for a Temporary Patient                 10               1               3              30
                                                       Increase for an Emergency *.
                                                                                         ---------------------------------------------------------------
    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 Reporting Form *.....           1,350               1               3           4,050
                                                      ``Qualifying Other Practitioner''              816               1           0.066              54
                                                       under 21 U.S.C. 823(g)(2)--Nurse
                                                       Practitioners.
                                                      ``Qualifying Other Practitioner''              590               1           0.066              39
                                                       under 21 U.S.C. 823(g)(2)--
                                                       Physician Assistants.
                                                      ``Qualifying Other Practitioner''              590               1           0.066              39
                                                       under 21 U.S.C. 823(g)(2)--
                                                       Certified Nurse Specialists.
                                                      ``Qualifying Other Practitioner''              590               1           0.066              39
                                                       under 21 U.S.C. 823(g)(2)--
                                                       Certified Nurse Mid-Wives.
                                                      ``Qualifying Other Practitioner''              590               1           0.066              39
                                                       under 21 U.S.C. 823(g)(2)--
                                                       Certified Registered Nurse
                                                       Anesthetists.
    Sub Total.......................................  ..................................           4,526  ..............  ..............           4,260
rrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrr
        Total Burden................................  ..................................           6,561  ..............  ..............           5,519
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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 December 2, 2019.

Summer King,
Statistician.
[FR Doc. 2019-21388 Filed 10-1-19; 8:45 am]
 BILLING CODE 4162-20-P