Agency Information Collection Activities: Proposed Collection; Comment Request, 14372-14373 [2017-05419]
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14372
Federal Register / Vol. 82, No. 52 / Monday, March 20, 2017 / Notices
checking the appropriate box(es) to
indicate what information FDA may
publish on the Web site.
The reporting burden in table 5
includes only the time necessary to fill
out and send the form, as compiling the
underlying information (including selfassessment reports, Risk Factor Study
data collection, outside audits, and
supporting documentation) is accounted
for under the recordkeeping estimates in
table 4.
FDA estimates the reporting burden
for this collection of information as
follows:
TABLE 5—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
responses per
respondent
Number of
respondents
Average
burden per
response
(hours)
Total annual
responses
Activity
FDA form
Submission of ‘‘FDA National Registry Report’’.
Request for documentation
of successful completion
of staff training.
3598 ..................................
500
1
500
0.1 (6 minutes)
50
Conference for Food Protection Training Plan
and Log.
500
3
1,500
0.1 (6 minutes)
150
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
of respondents and the hours per
response on its experience with the
Program Standards. As explained
previously in this document, FDA
estimates that no more than 500
Regulatory jurisdictions will participate
in the Program Standards in any given
year. FDA estimates a total of 6 minutes
annually for each enrolled jurisdiction
to complete the form. FDA bases its
estimate on the small number of data
elements on the form and the ease of
availability of the information. FDA
estimates that, annually, 500 regulatory
jurisdictions will submit one Form FDA
3598 for a total of 500 annual responses.
Each submission is estimated to take 0.1
hour (or 6 minutes) per response for a
total of 50 hours. In addition, FDA
estimates that, annually, 500 regulatory
jurisdictions will submit three requests
for documentation of successful
completion of staff training using the
CFP Training Plan and Log for a total of
1,500 annual responses. Each
submission is estimated to take 0.1 hour
(or 6 minutes) per response for a total
of 150 hours. Thus, the total reporting
burden for this information collection is
200 hours.
Dated: March 14, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017–05414 Filed 3–17–17; 8:45 am]
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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.
PO 00000
Frm 00030
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Sfmt 4703
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
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14373
Federal Register / Vol. 82, No. 52 / Monday, March 20, 2017 / Notices
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
Number of
respondents
Purpose of submission
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 ..................................................................
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 ...............................................................
Total ..........................................................................................................
Send comments to Summer King,
SAMHSA Reports Clearance Officer,
5600 Fishers Lane, Room 15E57–B,
Rockville, Maryland 20857, OR email a
copy to summer.king@samhsa.hhs.gov.
Written comments should be received
by May 19, 2017.
Summer King,
Statistician.
[FR Doc. 2017–05419 Filed 3–17–17; 8:45 am]
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DEPARTMENT OF HOMELAND
SECURITY
U.S. Customs and Border Protection
Accreditation and Approval of Camin
Cargo Control, Inc., as a Commercial
Gauger and Laboratory
U.S. Customs and Border
Protection, Department of Homeland
Security.
ACTION: Notice of accreditation and
approval of Camin Cargo Control, Inc.,
as a commercial gauger and laboratory.
AGENCY:
sradovich on DSK3GMQ082PROD with NOTICES
CBPL No.
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:
Responses/
respondent
Burden hours
Total
burden hours
816
1
.066
54
590
1
.066
39
1,406
........................
........................
93
Notice is hereby given,
pursuant to CBP regulations, that Camin
Cargo Control, Inc., has been approved
to gauge and accredited to test
petroleum and certain petroleum
products for customs purposes for the
next three years as of May 26, 2016.
DATES: The accreditation and approval
of Camin Cargo Control, Inc., as
commercial gauger and laboratory
became effective on May 26, 2016. The
next triennial inspection date will be
scheduled for May 2019.
FOR FURTHER INFORMATION CONTACT:
Approved Gauger and Accredited
Laboratories Manager, Laboratories and
Scientific Services Directorate, U.S.
Customs and Border Protection, 1300
Pennsylvania Avenue NW., Suite
1500N, Washington, DC 20229, tel. 202–
344–1060.
SUPPLEMENTARY INFORMATION: Notice is
hereby given pursuant to 19 CFR 151.12
and 19 CFR 151.13, that Camin Cargo
Control, Inc., 31 Fulton St. Unit A, New
Haven, CT 06513, has been approved to
gauge and accredited to test petroleum
and certain petroleum products for
SUMMARY:
customs purposes, in accordance with
the provisions of 19 CFR 151.12 and 19
CFR 151.13. Camin Cargo Control, Inc.,
is approved for the following gauging
procedures for petroleum and certain
petroleum products set forth by the
American Petroleum Institute (API):
API chapters
1 ...................
3 ...................
7 ...................
8 ...................
11 .................
12 .................
17 .................
Title
Vocabulary.
Tank gauging.
Temperature Determination.
Sampling.
Physical Properties Data.
Calculations.
Maritime Measurements.
Camin Cargo Control, Inc., is
accredited for the following laboratory
analysis procedures and methods for
petroleum and certain petroleum
products set forth by the U.S. Customs
and Border Protection Laboratory
Methods (CBPL) and American Society
for Testing and Materials (ASTM):
ASTM
Title
.............
.............
.............
.............
D287
D86
D445
D4294
27–20 .............
27–48 .............
27–50 .............
D4057
D4052
D93
Standard Test Method for API Gravity of crude Petroleum and Petroleum Products
Standard Test Method for Distillation of Petroleum Products
Standard Test Method for Kinematic Viscosity of Transparent and Opaque Liquids
Standard Test Method for Sulfur in Petroleum and Petroleum Products by Energy-Dispersive X-ray Fluorescence
Spectrometry
Standard Practice for Manual Sampling of Petroleum and Petroleum Products
Standard Test Method for Density and Relative Density of Liquids by Digital Density Meter
Standard Test Methods for Flash-Point by Pensky-Martens Closed Cup Tester
27–01
27–08
27–11
27–13
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]]>Agencies
[Federal Register Volume 82, Number 52 (Monday, March 20, 2017)]
[Notices]
[Pages 14372-14373]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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 summer.king@samhsa.hhs.gov. 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
