82 FR 14372 - Agency Information Collection Activities: Proposed Collection; Comment Request

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

Federal Register Volume 82, Issue 52 (March 20, 2017)

Page Range		14372-14373
FR Document		2017-05419

Federal Register, Volume 82 Issue 52 (Monday, March 20, 2017)

[Federal Register Volume 82, Number 52 (Monday, March 20, 2017)]
[Notices]
[Pages 14372-14373]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2017-05419]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Substance Abuse and Mental Health Services Administration


Agency Information Collection Activities: Proposed Collection; 
Comment Request

    In compliance with Section 3506(c)(2)(A) of the Paperwork Reduction 
Act of 1995 concerning opportunity for public comment on proposed 
collections of information, the Substance Abuse and Mental Health 
Services Administration (SAMHSA) will publish periodic summaries of 
proposed projects. To request more information on the proposed projects 
or to obtain a copy of the information collection plans, call the 
SAMHSA Reports Clearance Officer on (240) 276-1243.
    Comments are invited on: (a) Whether the proposed collections of 
information are necessary for the proper performance of the functions 
of the agency, including whether the information shall have practical 
utility; (b) the accuracy of the agency's estimate of the burden of the 
proposed collection of information; (c) ways to enhance the quality, 
utility, and clarity of the information to be collected; and (d) ways 
to minimize the burden of the collection of information on respondents, 
including through the use of automated collection techniques or other 
forms of information technology.

Proposed 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

[[Page 14373]]

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:

Use of Term of ``Qualifying Practitioners'' (NOI Sections 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 refers to ``other 
qualifying practitioners,'' simply as ``practitioners''.

Patient Limits (See NOI Section 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.

Identification of Training Providers

    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 training providers from a list.
    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
----------------------------------------------------------------------------------------------------------------

    Send comments to Summer King, SAMHSA Reports Clearance Officer, 
5600 Fishers Lane, Room 15E57-B, Rockville, Maryland 20857, OR email a 
copy to [email protected]. Written comments should be received 
by May 19, 2017.

Summer King,
Statistician.
[FR Doc. 2017-05419 Filed 3-17-17; 8:45 am]
 BILLING CODE 4162-20-P

14372 Federal Register / Vol. 82, No. 52 / Monday, March 20, 2017 / Notices

checking the appropriate box(es) to out and send the form, as compiling the for under the recordkeeping estimates in
indicate what information FDA may underlying information (including self- table 4.
publish on the Web site. assessment reports, Risk Factor Study FDA estimates the reporting burden
The reporting burden in table 5 data collection, outside audits, and for this collection of information as
includes only the time necessary to fill supporting documentation) is accounted follows:

TABLE 5—ESTIMATED ANNUAL REPORTING BURDEN 1
Average
Number of
Number of Total annual burden per
Activity FDA form responses per Total hours
respondents responses response
respondent (hours)

Submission of ‘‘FDA Na- 3598 .................................. 500 1 500 0.1 (6 minutes) 50
tional Registry Report’’.
Request for documentation Conference for Food Pro- 500 3 1,500 0.1 (6 minutes) 150
of successful completion tection Training Plan
of staff training. and Log.

Total ........................... ........................................... ........................ ........................ ........................ ........................... 200
1 There are no capital costs or operating and maintenance costs associated with this collection of information.

FDA bases its estimates of the number DEPARTMENT OF HEALTH AND Proposed Project: Notification of Intent
of respondents and the hours per HUMAN SERVICES To Use Schedule III, IV, or V Opioid
response on its experience with the Drugs for the Maintenance and
Program Standards. As explained Substance Abuse and Mental Health Detoxification Treatment of Opiate
previously in this document, FDA Services Administration Addiction by a ‘‘Qualifying Other
estimates that no more than 500 Practitioner’’—(OMB No. 0930–0369)—
Regulatory jurisdictions will participate Agency Information Collection Revision
in the Program Standards in any given Activities: Proposed Collection; The Substance Abuse and Mental
year. FDA estimates a total of 6 minutes Comment Request Health Services Administration
annually for each enrolled jurisdiction (SAMHSA) is requesting a revision from
In compliance with Section the Office of Management and Budget
to complete the form. FDA bases its
3506(c)(2)(A) of the Paperwork (OMB) for approval of the Notification
estimate on the small number of data
Reduction Act of 1995 concerning of Intent to Use Schedule III, IV, or V
elements on the form and the ease of
opportunity for public comment on Opioid Drugs for the Maintenance and
availability of the information. FDA
proposed collections of information, the Detoxification Treatment of Opiate
estimates that, annually, 500 regulatory
Substance Abuse and Mental Health Addiction by a ‘‘Qualifying Other
jurisdictions will submit one Form FDA
Services Administration (SAMHSA) Practitioner. The Notification of Intent
3598 for a total of 500 annual responses.
will publish periodic summaries of would allow SAMHSA to determine
Each submission is estimated to take 0.1
proposed projects. To request more whether other practitioners are eligible
hour (or 6 minutes) per response for a to prescribe certain approved narcotic
information on the proposed projects or
total of 50 hours. In addition, FDA treatment medications for the
to obtain a copy of the information
estimates that, annually, 500 regulatory maintenance or detoxification treatment
collection plans, call the SAMHSA
jurisdictions will submit three requests of opioid addiction.
Reports Clearance Officer on (240) 276–
for documentation of successful This Notification of Intent is a result
1243.
completion of staff training using the of the Comprehensive Addiction and
CFP Training Plan and Log for a total of Comments are invited on: (a) Whether Recovery Act (Pub. L. 114–198), which
1,500 annual responses. Each the proposed collections of information was signed into law on July 22, 2016.
submission is estimated to take 0.1 hour are necessary for the proper The law establishes criteria for nurse
(or 6 minutes) per response for a total performance of the functions of the practitioners (NPs) and physician
of 150 hours. Thus, the total reporting agency, including whether the assistants (PAs) to qualify for a waiver
burden for this information collection is information shall have practical utility; to prescribe covered medications. To be
200 hours. (b) the accuracy of the agency’s estimate eligible for a waiver, the NP or PA must:
of the burden of the proposed collection Be licensed under State law to prescribe
Dated: March 14, 2017. schedule III, IV, or V medications for the
of information; (c) ways to enhance the
Leslie Kux, quality, utility, and clarity of the treatment of pain; fulfill qualification
Associate Commissioner for Policy. information to be collected; and (d) requirements in the law for training and
[FR Doc. 2017–05414 Filed 3–17–17; 8:45 am] ways to minimize the burden of the experience; and fulfill qualification
BILLING CODE 4164–01–P collection of information on requirements in the law for appropriate
respondents, including through the use supervision by a qualifying physician.
sradovich on DSK3GMQ082PROD with NOTICES

of automated collection techniques or SAMHSA has the responsibility to
receive, review, approve, or deny waiver
other forms of information technology.
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

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Federal Register / Vol. 82, No. 52 / Monday, March 20, 2017 / Notices 14373

Controlled Substance Act (CSA), that Use of Term of ‘‘Qualifying patients for at least one year to increase
are specifically approved by the Food Practitioners’’ (NOI Sections 1, 2, 6, and their patient limit to 100. This second
and Drug Administration (FDA) for the 11) notification to treat 100 patients was
treatment of opioid addiction, and are The Statute Section 823(g)(2)(B)(i) omitted in the original NOI form.
not the subject of an ‘‘adverse refers to both physicians and mid-level Identification of Training Providers
determination.’’ The only medications providers as ‘‘qualifying practitioners.’’
that currently fulfill these requirements Therefore in order to avoid confusion The previous NOI required that the
are ones that contain the active and redundancy, the revised NOI refers practitioner to write in the name of
ingredient buprenorphine. to ‘‘other qualifying practitioners,’’ training provider(s)’ name(s). The
Below are the following changes: simply as ‘‘practitioners’’. revised NOI allows practitioners to
Patient Limits (See NOI Section 6: select training providers from a list.
Purpose of Notification) The following table is the estimated
Language was added allowing hour burden:
practitioners who have treated 30

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

Send comments to Summer King, SUMMARY: Notice is hereby given, customs purposes, in accordance with
SAMHSA Reports Clearance Officer, pursuant to CBP regulations, that Camin the provisions of 19 CFR 151.12 and 19
5600 Fishers Lane, Room 15E57–B, Cargo Control, Inc., has been approved CFR 151.13. Camin Cargo Control, Inc.,
Rockville, Maryland 20857, OR email a to gauge and accredited to test is approved for the following gauging
copy to summer.king@samhsa.hhs.gov. petroleum and certain petroleum procedures for petroleum and certain
Written comments should be received products for customs purposes for the petroleum products set forth by the
by May 19, 2017. next three years as of May 26, 2016. American Petroleum Institute (API):
Summer King, DATES: The accreditation and approval
Statistician. of Camin Cargo Control, Inc., as API chapters Title
commercial gauger and laboratory
[FR Doc. 2017–05419 Filed 3–17–17; 8:45 am]
became effective on May 26, 2016. The 1 ................... Vocabulary.
BILLING CODE 4162–20–P
next triennial inspection date will be 3 ................... Tank gauging.
scheduled for May 2019. 7 ................... Temperature Determination.
FOR FURTHER INFORMATION CONTACT: 8 ................... Sampling.
DEPARTMENT OF HOMELAND 11 ................. Physical Properties Data.
Approved Gauger and Accredited
SECURITY 12 ................. Calculations.
Laboratories Manager, Laboratories and
Scientific Services Directorate, U.S. 17 ................. Maritime Measurements.
U.S. Customs and Border Protection
Customs and Border Protection, 1300
Accreditation and Approval of Camin Pennsylvania Avenue NW., Suite Camin Cargo Control, Inc., is
Cargo Control, Inc., as a Commercial 1500N, Washington, DC 20229, tel. 202– accredited for the following laboratory
Gauger and Laboratory 344–1060. analysis procedures and methods for
SUPPLEMENTARY INFORMATION: Notice is petroleum and certain petroleum
AGENCY: U.S. Customs and Border
Protection, Department of Homeland hereby given pursuant to 19 CFR 151.12 products set forth by the U.S. Customs
Security. and 19 CFR 151.13, that Camin Cargo and Border Protection Laboratory
Control, Inc., 31 Fulton St. Unit A, New Methods (CBPL) and American Society
ACTION: Notice of accreditation and
Haven, CT 06513, has been approved to for Testing and Materials (ASTM):
approval of Camin Cargo Control, Inc.,
gauge and accredited to test petroleum
as a commercial gauger and laboratory.
and certain petroleum products for

CBPL No. ASTM Title
sradovich on DSK3GMQ082PROD with NOTICES

27–01 ............. D287 Standard Test Method for API Gravity of crude Petroleum and Petroleum Products
27–08 ............. D86 Standard Test Method for Distillation of Petroleum Products
27–11 ............. D445 Standard Test Method for Kinematic Viscosity of Transparent and Opaque Liquids
27–13 ............. D4294 Standard Test Method for Sulfur in Petroleum and Petroleum Products by Energy-Dispersive X-ray Fluorescence
Spectrometry
27–20 ............. D4057 Standard Practice for Manual Sampling of Petroleum and Petroleum Products
27–48 ............. D4052 Standard Test Method for Density and Relative Density of Liquids by Digital Density Meter
27–50 ............. D93 Standard Test Methods for Flash-Point by Pensky-Martens Closed Cup Tester

VerDate Sep<11>2014 18:36 Mar 17, 2017 Jkt 241001 PO 00000 Frm 00031 Fmt 4703 Sfmt 4703 E:\FR\FM\20MRN1.SGM 20MRN1

Document Created: 2017-03-18 01:10:52
Document Modified: 2017-03-18 01:10:52

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		82 FR 14372

82 FR 14372 - Agency Information Collection Activities: Proposed Collection; Comment Request

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

Federal Register Volume 82, Issue 52 (March 20, 2017)

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