81 FR 85584 - Agency Information Collection Activities Under Emergency Review by the Office of Management and Budget

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Substance Abuse and Mental Health Services Administration

Federal Register Volume 81, Issue 228 (November 28, 2016)

[Federal Register Volume 81, Number 228 (Monday, November 28, 2016)]
[Notices]
[Pages 85584-85585]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2016-28569]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Substance Abuse and Mental Health Services Administration


Agency Information Collection Activities Under Emergency Review 
by the Office of Management and Budget

    The Substance Abuse and Mental Health Services Administration 
(SAMHSA) has submitted the following request (see below) for emergency 
OMB review under the Paperwork Reduction Act (44 U.S.C. Chapter 35). 
OMB approval has been requested by January 12, 2017. A copy of the 
information collection plans may be obtained by calling the SAMHSA 
Reports Clearance Officer at (240) 276-1243.
    Title: 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''--NEW.
    OMB Number: 0930--New.
    Frequency: On Going.
    Affected public: Nurse Practitioners and Physician Assistants.
    The Substance Abuse and Mental Health Services Administration 
(SAMHSA) is requesting an emergency Office of Management and Budget 
(OMB) review and 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.
    Given the severity of the opioid epidemic, SAMHSA is requesting an 
emergency OMB approval. Emergency OMB approval will enable NPs and PAs 
to dramatically increase access to buprenorphine among individuals with 
opioid use disorder.
    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
 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.....
                                                 ---------------------------------------------------------------
    Total.......................................           1,406  ..............  ..............              93
----------------------------------------------------------------------------------------------------------------


[[Page 85585]]

    Written comments and recommendations concerning the proposed 
information collection should be sent by January 12, 2017 to the SAMHSA 
Desk Officer at the Office of Information and Regulatory Affairs, 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: 202-395-5806. 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. 2016-28569 Filed 11-25-16; 8:45 am]
 BILLING CODE 4162-20-P