82 FR 26114 - Agency Information Collection Activities: Submission for OMB Review; Comment Request

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

Federal Register Volume 82, Issue 107 (June 6, 2017)

Page Range		26114-26116
FR Document		2017-11632
Federal Register, Volume 82 Issue 107 (Tuesday, June 6, 2017)
[Federal Register Volume 82, Number 107 (Tuesday, June 6, 2017)]
[Notices]
[Pages 26114-26116]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2017-11632]


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

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
Federal Register / Vol. 82, No. 107 / Tuesday, June 6, 2017 / Notices 26115

Paperwork Reduction Act (44 U.S.C. are ones that contain the active NOI. The term ‘‘qualifying physician’’ is
Chapter 35). To request a copy of these ingredient buprenorphine. specifically defined under 21 U.S.C.
documents, call the SAMHSA Reports Below are the following changes: 823(g)(2)(G)(ii).
Clearance Officer on (240) 276–1243. Address of Practice Location (NOI Item Certification of Qualifying Criteria (NOI
Project: Notification of Intent To Use 2 and Instructions Section) Item 8)
Schedule III, IV, or V Opioid Drugs for The newly revised instructions in
the Maintenance and Detoxification The law specifically authorizes NPs
Section 2 now acknowledge that and PAs as eligible to apply to be a
Treatment of Opiate Addiction by a practitioners may practice at multiple
‘‘Qualifying Other Practitioner’’—(OMB ‘‘Qualifying Other Practitioner.’’
practice locations, but may only list a However, the proposed Notification of
No. 0930–0369)—Revision practice location address that matches Intent form asks applicants to certify
The Substance Abuse and Mental their DEA registration practice site. that they are either an ‘‘advanced
Health Services Administration Furthermore, the revised section practice nurse or physician assistant.’’
(SAMHSA) is requesting a revision from provides a link where practitioners may This difference in terminology was
the Office of Management and Budget add additional practice sites.
considered confusing to potential
(OMB) for approval of the Notification Use of Term of ‘‘Other Qualifying applicants. SAMHSA revised the first
of Intent to Use Schedule III, IV, or V Practitioners’’ (See NOI Items 1, 2, 6, attestation in Certification of Qualifying
Opioid Drugs for the Maintenance and and 11) Criteria to read ‘‘I certify that I am either
Detoxification Treatment of Opiate a nurse practitioner or physician
Addiction by a ‘‘Qualifying Other The Statute section 823(g)(2)(B)(i)
refers to both physicians and mid-level assistant who satisfies the definition of
Practitioner.’’ The Notification of Intent a ‘qualifying other practitioner.’’
would allow SAMHSA to determine providers as ‘‘qualifying practitioners.’’
whether other practitioners are eligible Therefore in order to avoid confusion Identification of Training Providers
to prescribe certain approved narcotic and redundancy the revised NOI (NOI Item 8)
treatment medications for the Instructions Section refers to ‘‘other
qualifying practitioners,’’ simply as The previous NOI required that the
maintenance or detoxification treatment practitioner to write-in the name of
of opioid addiction. ‘‘practitioners.’’
training provider(s)’ name(s). The
This Notification of Intent is a result Use of Term of ‘‘Supervisory Physician revised NOI allows practitioners to
of the Comprehensive Addiction and or Collaborative Physician’’ (NOI Item 8) select all applicable training providers
Recovery Act (Pub. L. 114–198), which
The third and fourth criteria in this from a drop down list.
was signed into law on July 22, 2016.
section created confusion regarding the
The law establishes criteria for nurse Certification of Capacity (NOI Item 9)
relationship with a qualifying physician
practitioners (NPs) and physician since providers are required to be
assistants (PAs) to qualify for a waiver The second attestation in this section
supervised by OR work with a was missing a verb. SAMHSA corrected
to prescribe covered medications. To be collaborative physician, but not both.
eligible for a waiver, the NP or PA must: this error to reflect the statutory
Therefore, the word ‘‘and’’ was replaced language requiring qualifying
Be licensed under State law to prescribe by ‘‘or’’.
schedule III, IV, or V medications for the practitioners to attest to the capacity to
treatment of pain; fulfill qualification Patient Limits (Item 6: Purpose of provide directly or by referral.
requirements in the law for training and Notification) Certification of Maximum Patient Load
experience; and fulfill qualification Language was added allowing (NOI Item 10)
requirements in the law for appropriate practitioners who have treated 30
supervision by a qualifying physician. It was clarified that the second option
patients for at least one year to increase
SAMHSA has the responsibility to regarding increasing patient load to 100
their patient limit to 100. This second
receive, review, approve, or deny waiver refers to a second notifications (as
notification to treat 100 patients was
requests. specified in the analogous NOI form for
omitted in the original NOI form.
Practitioners who meet the statutory physicians).
requirements will be eligible to Use of Term of ‘‘Qualifying Physician’’
(NOI Item 8) Privacy Act Information
prescribe only those opioid treatment
medications that are controlled in The Controlled Substance Act (CSA) This section noted that medical
Schedules III, IV, or V, under the requires that NPs and PAs be supervised specialty societies be used to verify
Controlled Substance Act (CSA), that (or collaborate with) a ‘‘qualifying practitioner credentials. The revised
are specifically approved by the Food physician’’ when required by state law NOI replaced the words ‘‘medical
and Drug Administration (FDA) for the to work with a supervising physician specialty societies’’ with ‘‘relevant
treatment of opioid addiction, and are (see 21 U.S.C. 823(g)(2)(G)(iv)(III)). licensing boards to verify practitioners’
not the subject of an ‘‘adverse SAMHSA added a footnote with a qualifications.’’
determination.’’ The only medications definition of the term ‘‘qualifying The following table is the estimated
that currently fulfill these requirements physician’’ means in the context of the hour burden:

Number of Responses/ Total burden
Purpose of submission Burden hours
respondents respondent hours
mstockstill on DSK30JT082PROD with NOTICES

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 U.S.C.
823(g)(2)—Nurse Practitioners .................................................................... 816 1 .066 54

VerDate Sep<11>2014 20:52 Jun 05, 2017 Jkt 241001 PO 00000 Frm 00074 Fmt 4703 Sfmt 4703 E:\FR\FM\06JNN1.SGM 06JNN1
26116 Federal Register / Vol. 82, No. 107 / Tuesday, June 6, 2017 / Notices

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 U.S.C.
823(g)(2)—Physician Assistants .................................................................. 590 1 .066 39

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

Written comments and ADDRESSES: Nominations must be in the Office of Management and Budget
recommendations concerning the writing and submitted via email to (OMB).1
proposed information collection should HCFAC.application@hud.gov. The HCFAC shall consist of not more
be sent by July 6, 2017 to the SAMHSA Individuals that do not have internet than 12 individuals appointed by the
Desk Officer at the Office of Information access may submit nominations to Secretary. The membership will equally
and Regulatory Affairs, Office of Marjorie George, Housing Program represent the mortgage industry, real
Management and Budget (OMB). To Technical Specialist, U.S. Department of estate industry, consumers, and HUD-
ensure timely receipt of comments, and Housing and Urban Development, Office approved housing counseling agencies.
to avoid potential delays in OMB’s of Housing Counseling, Office of Each member shall be appointed in his
receipt and processing of mail sent Outreach and Capacity Building, 200 or her individual capacity for a term of
through the U.S. Postal Service, Jefferson Avenue, Suite 300, Memphis, 3 years and may be reappointed at the
commenters are encouraged to submit TN 38103. discretion of the Secretary. Of the 12
their comments to OMB via email to: members first appointed to the HCFAC
FOR FURTHER INFORMATION CONTACT:
OIRA_Submission@omb.eop.gov. in 2016, 4 were appointed for an initial
Marjorie George, Housing Program
Although commenters are encouraged to term of 1 year, 4 were appointed for a
Technical Specialist, Office of Housing
send their comments via email, term of 2 years, and 4 were appointed
Counseling, U.S. Department of Housing
commenters may also fax their for a term of 3 years. The initial 12
and Urban Development, 200 Jefferson
comments to: 202–395–7285. appointments were made by the
Avenue, Suite 300, Memphis, TN 38103;
Commenters may also mail them to: Secretary on June 1, 2016, and the one-
telephone number (901) 544–4228 (this
Office of Management and Budget, year appointees terms will expire on
is not a toll-free number). Persons who
Office of Information and Regulatory May 31, 2017. This notice indicates the
have difficulty hearing or speaking may Secretary’s decision to reappoint to new
Affairs, New Executive Office Building, access this number via TTY by calling
Room 10102, Washington, DC 20503. three-year terms the original appointees
the toll-free Federal Relay Service at for consumer, mortgage, and housing
Summer King, (800) 877–8339 (toll-free number). counseling and to solicit applications to
Statistician. Individuals with questions may also address a vacancy for real estate due to
[FR Doc. 2017–11632 Filed 6–5–17; 8:45 am]
email HCFAC.application@hud.gov and a withdrawal from consideration.
in the subject line write ‘‘HCFAC
BILLING CODE 4162–20–P
application question.’’ III. Nominations for the Housing
SUPPLEMENTARY INFORMATION:
Counseling Federal Advisory
Committee
DEPARTMENT OF HOUSING AND I. Background and Authority HUD is seeking nominations for an
URBAN DEVELOPMENT The Housing Counseling Federal individual whose experience is
Advisory Committee (HCFAC) is representative of the real estate industry
[Docket No. FR–5858–N–07] congressionally mandated to provide to fill one vacancy. Individuals may
advice to the Office of Housing nominate themselves. Nominees must
Solicitation of Appointment
Counseling (OHC) (Pub. L. 111–203). be U.S. citizens, and cannot be
Nominations to the Housing
The HCFAC provides the OHC valuable employees of the U.S. Government. All
Counseling Federal Advisory
advice regarding its mission to provide nominees will be serving in their
Committee
individuals and families with the ‘‘individual capacity’’ and not in a
AGENCY: Office of the Assistant knowledge they need to obtain, sustain, ‘‘representative capacity,’’ therefore, no
Secretary for Housing—Federal Housing and improve their housing through a Federally-registered lobbyists may serve
Commissioner, Department of Housing strong national network of HUD- on the HCFAC.2 Individual capacity, as
and Urban Development (HUD). approved housing counseling agencies clarified by OMB, refers to individuals
ACTION: Notice of Solicitation of and HUD-certified counselors. The who are appointed to committees to
Appointment Nominations. HCFAC, however, has no role in
reviewing or awarding of OHC housing 1 See 76 FR 61756 (‘‘Final Guidance on

SUMMARY: The Department of Housing counseling grants and procurement Appointments of Lobbyists to Federal Boards and
Commissions’’); and 79 FR 47482 (‘‘Revised
and Urban Development (HUD) contracts. The HCFAC is subject to the Guidance on Appointment of Lobbyists to Federal
established the Housing Counseling requirements of the Federal Advisory Advisory Committees, Boards, and Commissions’’);
Federal Advisory Committee (HCFAC) Committee Act (5 U.S.C. Appendix), 41 see also https://www.whitehouse.gov/the:press-
mstockstill on DSK30JT082PROD with NOTICES

on April 14, 2015. This notice invites CFR parts 101–6 and 102–3, and office/presidential-memorandum-lobbyists-agency-
boards-and-commissions (‘‘Lobbyist on Agency
the public to nominate individuals to Presidential Memorandum ‘‘Final Boards and Commissions’’).
fill one vacancy representing the real Guidance on Appointments of Lobbyists 2 See 79 FR 47482 (‘‘Revised Guidance on

estate industry for a three-year term. to Federal Boards and Commissions,’’ Appointment of Lobbyists to Federal Advisory
dated June 18, 2010, along with any Committees, Boards, and Commissions’’) (clarifying
DATES: Please submit nominations as
that federally registered lobbyists may not serve on
soon as possible, but no later than June relevant guidance published in the advisory committee, board, or Commission in an
21, 2017. Federal Register or otherwise issued by ‘‘individual capacity.’’).

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Document Created: 2017-06-06 06:21:11
Document Modified: 2017-06-06 06:21:11
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		82 FR 26114
82 FR 26114 - Agency Information Collection Activities: Submission for OMB Review; Comment Request

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

Federal Register Volume 82, Issue 107 (June 6, 2017)

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