[Federal Register Volume 82, Number 107 (Tuesday, June 6, 2017)]
[Notices]
[Pages 26114-26116]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-11632]


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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

[[Page 26115]]

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 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 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:

Address of Practice Location (NOI Item 2 and Instructions Section)

    The newly revised instructions in Section 2 now acknowledge that 
practitioners may practice at multiple practice locations, but may only 
list a practice location address that matches their DEA registration 
practice site. Furthermore, the revised section provides a link where 
practitioners may add additional practice sites.

Use of Term of ``Other Qualifying Practitioners'' (See NOI Items 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 Instructions Section 
refers to ``other qualifying practitioners,'' simply as 
``practitioners.''

Use of Term of ``Supervisory Physician or Collaborative Physician'' 
(NOI Item 8)

    The third and fourth criteria in this section created confusion 
regarding the relationship with a qualifying physician since providers 
are required to be supervised by OR work with a collaborative 
physician, but not both. Therefore, the word ``and'' was replaced by 
``or''.

Patient Limits (Item 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.

Use of Term of ``Qualifying Physician'' (NOI Item 8)

    The Controlled Substance Act (CSA) requires that NPs and PAs be 
supervised (or collaborate with) a ``qualifying physician'' when 
required by state law to work with a supervising physician (see 21 
U.S.C. 823(g)(2)(G)(iv)(III)). SAMHSA added a footnote with a 
definition of the term ``qualifying physician'' means in the context of 
the NOI. The term ``qualifying physician'' is specifically defined 
under 21 U.S.C. 823(g)(2)(G)(ii).

Certification of Qualifying Criteria (NOI Item 8)

    The law specifically authorizes NPs and PAs as eligible to apply to 
be a ``Qualifying Other Practitioner.'' However, the proposed 
Notification of Intent form asks applicants to certify that they are 
either an ``advanced practice nurse or physician assistant.'' This 
difference in terminology was considered confusing to potential 
applicants. SAMHSA revised the first attestation in Certification of 
Qualifying Criteria to read ``I certify that I am either a nurse 
practitioner or physician assistant who satisfies the definition of a 
`qualifying other practitioner.''

Identification of Training Providers (NOI Item 8)

    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 all applicable training providers from a drop 
down list.

Certification of Capacity (NOI Item 9)

    The second attestation in this section was missing a verb. SAMHSA 
corrected this error to reflect the statutory language requiring 
qualifying practitioners to attest to the capacity to provide directly 
or by referral.

Certification of Maximum Patient Load (NOI Item 10)

    It was clarified that the second option regarding increasing 
patient load to 100 refers to a second notifications (as specified in 
the analogous NOI form for physicians).

Privacy Act Information

    This section noted that medical specialty societies be used to 
verify practitioner credentials. The revised NOI replaced the words 
``medical specialty societies'' with ``relevant licensing boards to 
verify practitioners' qualifications.''
    The following table is the estimated hour burden:

----------------------------------------------------------------------------------------------------------------
                                                     Number of      Responses/                     Total burden
              Purpose of submission                 respondents     respondent     Burden hours        hours
----------------------------------------------------------------------------------------------------------------
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
 U.S.C. 823(g)(2)--Nurse Practitioners..........

[[Page 26116]]

 
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
 U.S.C. 823(g)(2)--Physician Assistants.........
                                                 ---------------------------------------------------------------
    Total.......................................           1,406  ..............  ..............              93
----------------------------------------------------------------------------------------------------------------

    Written comments and recommendations concerning the proposed 
information collection should be sent by July 6, 2017 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. 2017-11632 Filed 6-5-17; 8:45 am]
 BILLING CODE 4162-20-P