[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.

----------------------------------------------------------------------------------------------------------------
                                                     Estimated                        Burden/
      42 CFR citation            Purpose of          number of      Responses/       response      Total burden
                                 submission         respondents     respondent        (hrs.)          (hrs.)
----------------------------------------------------------------------------------------------------------------
                            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.
                                                 ---------------------------------------------------------------
                               Subtotal.........           2,850  ..............  ..............             214
----------------------------------------------------------------------------------------------------------------
                     Burden Associated with the Final Rule That Increased the Patient Limit
----------------------------------------------------------------------------------------------------------------
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 *.
                                                 ---------------------------------------------------------------
                               Subtotal.........           2,361  ..............  ..............           1,256
----------------------------------------------------------------------------------------------------------------
               New Burden Associated with the Final Rule That Outlined the Reporting Requirements
----------------------------------------------------------------------------------------------------------------
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.
                                                 ---------------------------------------------------------------
                               Subtotal.........           4,526  ..............  ..............           4,260
                                                 ---------------------------------------------------------------
                                 Total Burden...           6,561  ..............  ..............           5,519
----------------------------------------------------------------------------------------------------------------

    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]
 BILLING CODE 4162-20-P