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)

Page Range		85584-85585
FR Document		2016-28569

Federal Register, Volume 81 Issue 228 (Monday, 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]


-----------------------------------------------------------------------

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

85584 Federal Register / Vol. 81, No. 228 / Monday, November 28, 2016 / Notices

DEPARTMENT OF HEALTH AND Drive, Room 5210, MSC 7846, Bethesda, MD Maintenance and Detoxification
HUMAN SERVICES 20892, (301) 435–1246, edwardss@ Treatment of Opiate Addiction by a
csr.nih.gov. ‘‘Qualifying Other Practitioner. The
National Institutes of Health (Catalogue of Federal Domestic Assistance Notification of Intent would allow
Program Nos. 93.306, Comparative Medicine; SAMHSA to determine whether other
Center For Scientific Review; Notice of 93.333, Clinical Research, 93.306, 93.333, practitioners are eligible to prescribe
Closed Meetings 93.337, 93.393–93.396, 93.837–93.844,
93.846–93.878, 93.892, 93.893, National
certain approved narcotic treatment
Pursuant to section 10(d) of the Institutes of Health, HHS) medications for the maintenance or
Federal Advisory Committee Act, as detoxification treatment of opioid
Dated: November 21, 2016. addiction.
amended (5 U.S.C. App.), notice is
Sylvia L. Neal,
hereby given of the following meetings. This Notification of Intent is a result
The meetings will be closed to the Program Analyst, Office of Federal Advisory
of the Comprehensive Addiction and
Committee Policy.
public in accordance with the Recovery Act (Pub. L. 114–198), which
provisions set forth in sections [FR Doc. 2016–28415 Filed 11–25–16; 8:45 am]
was signed into law on July 22, 2016.
552b(c)(4) and 552b(c)(6), Title 5 U.S.C., BILLING CODE 4140–01–P
The law establishes criteria for nurse
as amended. The grant applications and practitioners (NPs) and physician
the discussions could disclose assistants (PAs) to qualify for a waiver
confidential trade secrets or commercial DEPARTMENT OF HEALTH AND
to prescribe covered medications. To be
property such as patentable material, HUMAN SERVICES
eligible for a waiver, the NP or PA must:
and personal information concerning Substance Abuse and Mental Health be licensed under State law to prescribe
individuals associated with the grant Services Administration schedule III, IV, or V medications for the
applications, the disclosure of which treatment of pain; fulfill qualification
would constitute a clearly unwarranted Agency Information Collection requirements in the law for training and
invasion of personal privacy. Activities Under Emergency Review by experience; and fulfill qualification
Name of Committee: Center for Scientific the Office of Management and Budget requirements in the law for appropriate
Review Special Emphasis Panel, Member supervision by a qualifying physician.
Conflict: Psychiatric Disorders and The Substance Abuse and Mental SAMHSA has the responsibility to
Addiction. Health Services Administration receive, review, approve, or deny waiver
Date: December 13, 2016. (SAMHSA) has submitted the following requests.
Time: 1:00 p.m. to 3:00 p.m. request (see below) for emergency OMB
Agenda: To review and evaluate grant Practitioners who meet the statutory
review under the Paperwork Reduction
applications. requirements will be eligible to
Act (44 U.S.C. Chapter 35). OMB
Place: National Institutes of Health, 6701 prescribe only those opioid treatment
Rockledge Drive, Bethesda, MD 20892, approval has been requested by January
medications that are controlled in
(Telephone Conference Call). 12, 2017. A copy of the information
Schedules III, IV, or V, under the
Contact Person: Samuel C Edwards, Ph.D., collection plans may be obtained by
Controlled Substance Act (CSA), that
IRG Chief, Center for Scientific Review, calling the SAMHSA Reports Clearance
National Institutes of Health, 6701 Rockledge are specifically approved by the Food
Officer at (240) 276–1243.
Drive, Room 5210, MSC 7846, Bethesda, MD and Drug Administration (FDA) for the
Title: Notification of Intent to Use
20892, (301) 435–1246, edwardss@ treatment of opioid addiction, and are
Schedule III, IV, or V Opioid Drugs for
csr.nih.gov. not the subject of an ‘‘adverse
the Maintenance and Detoxification
Name of Committee: Center for Scientific determination.’’ The only medications
Treatment of Opiate Addiction by a
Review Special Emphasis Panel, Member that currently fulfill these requirements
Conflict: Neurovirology, Neuroimmunology, ‘‘Qualifying Other Practitioner’’—NEW.
OMB Number: 0930—New. are ones that contain the active
Neurodevelopmental Disorders, and ingredient buprenorphine.
Anticancer Drugs. Frequency: On Going.
Date: December 15, 2016. Affected public: Nurse Practitioners Given the severity of the opioid
Time: 1:00 p.m. to 3:00 p.m. and Physician Assistants. epidemic, SAMHSA is requesting an
Agenda: To review and evaluate grant The Substance Abuse and Mental emergency OMB approval. Emergency
applications. Health Services Administration OMB approval will enable NPs and PAs
Place: National Institutes of Health, 6701 to dramatically increase access to
Rockledge Drive, Bethesda, MD 20892,
(SAMHSA) is requesting an emergency
Office of Management and Budget buprenorphine among individuals with
(Telephone Conference Call).
Contact Person: Samuel C. Edwards, Ph.D., (OMB) review and approval of the opioid use disorder.
IRG Chief, Center for Scientific Review, Notification of Intent to Use Schedule The following table is the estimated
National Institutes of Health, 6701 Rockledge III, IV, or V Opioid Drugs for the hour burden:

Number of Responses/ Total burden
Purpose of submission Burden hours
respondents respondent hours

Notification of Intent for Qualifying Other 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
§ 823(g)(2)—Nurse Practitioners .................................................................. 816 1 .066 54
Notification of Intent for Qualifying Other Practitioner to Use Schedule III,
mstockstill on DSK3G9T082PROD with NOTICES

IV, or V Opioid Drugs for the Maintenance and Detoxification Treatment
of Opiate Addiction by a ‘‘Qualifying Other Practitioner’’ under 21 USC
§ 823(g)(2)—Physician Assistants ............................................................... 590 1 .066 39

Total .......................................................................................................... 1,406 ........................ ........................ 93

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Federal Register / Vol. 81, No. 228 / Monday, November 28, 2016 / Notices 85585

Written comments and Project: National Mental Health This request for a revision seeks to
recommendations concerning the Services Survey (N–MHSS) (OMB No. change the content of the currently
proposed information collection should 0930–0119)—Revision approved abbreviated N–MHSS (i.e., N–
be sent by January 12, 2017 to the MHSS–Locator) survey instrument, and
SAMHSA Desk Officer at the Office of The Substance Abuse and Mental the previously approved 2014 and 2016
Information and Regulatory Affairs, Health Services Administration full-scale N–MHSS (OMB No. 0930–
OMB. To ensure timely receipt of (SAMHSA), Center for Behavioral 0119) to accommodate two related N–
comments, and to avoid potential delays Health Statistics and Quality (CBHSQ) MHSS activities:
in OMB’s receipt and processing of mail is requesting a revision to the National (1) collection of information from the
sent through the U.S. Postal Service, Mental Health Services Survey (N– total N–MHSS universe of mental health
commenters are encouraged to submit MHSS) (OMB No. 0930–0119), which treatment facilities during 2017, 2018,
their comments to OMB via email to: expires on February 28, 2017. The N– and 2019; and
OIRA_Submission@omb.eop.gov. MHSS provides annual national and (2) collection of information on newly
Although commenters are encouraged to state-level data on the number and identified facilities throughout the year
send their comments via email, characteristics of mental health as they are identified so that new
commenters may also fax their treatment facilities in the United States facilities can quickly be added to the
comments to: 202–395–5806. and biennial national and state-level online Locator.
Commenters may also mail them to: data on the number and characteristics The survey mode for both data
Office of Management and Budget, of persons treated in these facilities. collection activities will be web with
Office of Information and Regulatory The N–MHSS will provide updated telephone follow-up. A paper
Affairs, New Executive Office Building, information about facilities for questionnaire will also be available to
Room 10102, Washington, DC 20503. SAMHSA’s online Behavioral Health facilities who request one.
Treatment Services Locator (see: https:// The database resulting from the N–
Summer King,
findtreatment.samhsa.gov), which was MHSS will be used to update
Statistician.
last updated with information from the SAMHSA’s online Behavioral Health
[FR Doc. 2016–28569 Filed 11–25–16; 8:45 am] abbreviated N–MHSS (N–MHSS-Locator Treatment Services Locator and to
BILLING CODE 4162–20–P Survey) in 2015. An abbreviated N– produce an electronic version of a
MHSS (N–MHSS-Locator Survey) will national directory of mental health
be conducted in 2017 and 2019 to facilities, for use by the general public,
DEPARTMENT OF HEALTH AND update the information about facilities behavioral health professionals, and
HUMAN SERVICES in the online Locator. A full-scale N– treatment service providers. In addition,
Substance Abuse and Mental Health MHSS will be conducted in 2018 to a data file derived from the survey will
Services Administration collect (1) information about facilities be used to produce a summary report
needed for updating the online Locator, providing national and state-level
Agency Information Collection such as the facility name and address, outcomes. The summary report and a
Activities: Submission for OMB specific services offered, and special public-use data file will be used by
Review; Comment Request client groups served and (2) additional researchers, mental health professionals,
information about client counts and the State governments, the U.S. Congress,
Periodically, the Substance Abuse and demographics of persons treated in and the general public.
Mental Health Services Administration these facilities. Three small surveys are The request for OMB approval will
(SAMHSA) will publish a summary of proposed for adding new facilities to the include a request to conduct an
information collection requests under online Locator as they become known to abbreviated N–MHSS-Locator survey in
OMB review, in compliance with the SAMHSA. Both the 2017 N–MHSS- 2017 and 2019, and the full-scale N–
Paperwork Reduction Act (44 U.S.C. Locator Survey and the addition of new MHSS in 2018.
Chapter 35). To request a copy of these facilities to the online Locator will use The following table summarizes the
documents, call the SAMHSA Reports the same N–MHSS-Locator Survey estimated annual response burden for
Clearance Officer on (240) 276–1243. instrument. the N–MHSS:

ESTIMATED ANNUAL RESPONSE BURDEN FOR THE N–MHSS
Responses
Number of Average hours Total burden
Type of respondent per respond-
respondents per response hours
ent

Facilities in N–MHSS-Locator Survey universe in 2017 and 2019 ................. 17,000 1 0.42 7,140
Newly identified facilities in Between-Survey Update in 2017, 2018, and
2019 1 ........................................................................................................... 1,700 1 0.42 714
Facilities in full-scale N–MHSS universe in 2018 ............................................ 17,000 1 0.75 12,750

Average Annual Total ............................................................................... 18,700 1 0.62 9,724
1 Collection of information on newly identified facilities throughout the year, as they are identified, so that new facilities can quickly be added to
the Locator.
mstockstill on DSK3G9T082PROD with NOTICES

Written comments and Information and Regulatory Affairs, sent through the U.S. Postal Service,
recommendations concerning the Office of Management and Budget commenters are encouraged to submit
proposed information collection should (OMB). To ensure timely receipt of their comments to OMB via email to:
be sent by December 28, 2016 to the comments, and to avoid potential delays OIRA_Submission@omb.eop.gov.
SAMHSA Desk Officer at the Office of in OMB’s receipt and processing of mail Although commenters are encouraged to

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Document Created: 2018-02-14 08:35:52
Document Modified: 2018-02-14 08:35:52

Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Notices
FR Citation		81 FR 85584

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

DEPARTMENT OF HEALTH AND HUMAN SERVICESSubstance Abuse and Mental Health Services Administration

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

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