Agency Information Collection Activities: Proposed Collection; Comment Request, 52521-52522 [2019-21388]
Download as PDF
<![CDATA[
Federal Register / Vol. 84, No. 191 / Wednesday, October 2, 2019 / Notices
Contact Person: Erin E. Gray, Ph.D.,
Scientific Review Officer, Division of
Extramural Activities, National Institute of
Mental Health, National Institutes of Health,
6001 Executive Boulevard, NSC 6152B,
Bethesda, MD 20892, 301–402–8152,
erin.gray@nih.gov.
(Catalogue of Federal Domestic Assistance
Program No. 93.242, Mental Health Research
Grants, National Institutes of Health, HHS)
Dated: September 26, 2019.
Melanie J. Pantoja,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2019–21396 Filed 10–1–19; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Substance Abuse and Mental Health
Services Administration
Agency Information Collection
Activities: Proposed Collection;
Comment Request
khammond on DSKJM1Z7X2PROD with NOTICES
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 Under 21 U.S.C. 823(g)(2)
(OMB No. 0930–0234 and OMB No.
0930–0369)—Revision
The Drug Addiction Treatment Act of
2000 (‘‘DATA,’’ Pub. L. 106–310)
VerDate Sep<11>2014
16:42 Oct 01, 2019
Jkt 250001
amended the Controlled Substances Act
(21 U.S.C. 823(g)(2)) to permit
qualifying practitioners to seek and
obtain waivers to prescribe certain
approved narcotic treatment drugs for
the treatment of opiate addiction. The
legislation set eligibility requirements
and certification requirements as well as
an interagency notification review
process for practitioners who seek
waivers. To implement these provisions,
SAMHSA developed Notification of
Intent Forms that facilitate the
submission and review of notifications.
The forms provide the information
necessary to determine whether
practitioners meets the qualifications for
waivers set forth under the law at the
30-, 100-, and 275-patient limits. This
includes the annual reporting
requirements for practitioners with
waivers for a 275 patient limit. On
October 24, 2018, the Substance Use
Disorder Prevention that Promotes
Opioid Recovery and Treatment for
Patients and Communities (SUPPORT)
Act (Pub. L. 115–71) was signed into
law. Sections 3201–3202 of the
SUPPORT Act made several
amendments to the Controlled
Substances Act regarding office-based
opioid treatment that affords
practitioners greater flexibility in the
provision of medication-assisted
treatment (MAT).
The SUPPORT Act expands the
definition of ‘‘qualifying other
practitioner’’ enabling Clinical Nurse
Specialists, Certified Registered Nurse
Anesthetists, and Certified Nurse
Midwives (CNSs, CRNAs, and CNMs) to
apply for a Drug Addiction Treatment
Act of 2000 (DATA) waiver until
October 1, 2023. It also allows qualified
practitioners (i.e., MDs, DOs, NPs, PAs,
CNSs, CRNAs, and CNMs) who are
board certified in addiction medicine or
addiction psychiatry, -or- practitioners
who provide MAT in a qualified
practice setting, to start treating up to
100 patients in the first year of MAT
practice (as defined in 42 CFR 8.2) with
a waiver.
Further, the SUPPORT Act extends
the ability to treat up to 275 patients to
‘‘qualifying other practitioners’’ (i.e.,
NPs, PAs, CNSs, CRNAs, and CNMs) if
they have a waiver to treat up 100
patients for at least one year and
provide medication-assisted treatment
with covered medications (as such
terms are defined under 42 CFR 8.2) in
a qualified practice setting as described
under 42 CFR 8.615. Finally, the
SUPPORT Act also expands how
physicians could qualify for a waiver.
Under the statute now, physicians can
PO 00000
Frm 00068
Fmt 4703
Sfmt 4703
52521
qualify for a waiver if they have
received at least 8 hours of training on
treating and managing opiate-dependent
patients, as listed in the statute if the
physician graduated in good standing
from an accredited school of allopathic
medicine or osteopathic medicine in the
United States during the 5-year period
immediately preceding the date on
which the physician submits to
SAMHSA. In order to expedite the new
provisions of the SUPPORT Act,
SAMHSA sought and received a Public
Health Emergency Paperwork Reduction
Act Waiver. Practitioners may use the
form for four types of notifications: (a)
New Notification to treat up to 30
patients; (b) New Notification, with the
intent to immediately facilitate
treatment of an individual (one) patient;
(c) Second notification of need and
intent to treat up to 100 patients; and (d)
New notification to treat up to 100
patients. Under ‘‘new’’ notifications,
practitioners may make their initial
waiver requests to SAMHSA.
‘‘Immediate’’ notifications inform
SAMHSA and the Attorney General of a
practitioner’s intent to prescribe
immediately to facilitate the treatment
of an individual (one) patient under 21
U.S.C. 823(g)(2)(E)(ii). The form collects
data on the following items: Practitioner
name; state medical license number;
medical specialty; and DEA registration
number; address of primary practice
location, telephone and fax numbers;
email address; name and address of
group practice; group practice employer
identification number; names and DEA
registration numbers of group
practitioners; purpose of notification:
new, immediate, or renewal;
certification of qualifying criteria for
treatment and management of opiate
dependent patients; certification of
capacity to provide directly or refer
patients for appropriate counseling and
other appropriate ancillary services;
certification of maximum patient load,
certification to use only those drug
products that meet the criteria in the
law. The form also notifies practitioners
of Privacy Act considerations, and
permits practitioners to expressly
consent to disclose limited information
to the SAMHSA Buprenorphine
Physician and Behavioral Health
Treatment Services locators. The
following table summarizes the
estimated annual burden for the use of
this form.
E:\FR\FM\02OCN1.SGM
02OCN1
52522
Federal Register / Vol. 84, No. 191 / Wednesday, October 2, 2019 / Notices
42 CFR citation
Estimated
number of
respondents
Purpose of submission
Burden/
response
(hr.)
Responses/
respondent
Total burden
(hrs.)
Notification of Intent ........................................
Notification to Prescribe Immediately .............
Notice to Treat up to 100 patients .................
Notice to Treat up to 275 patients .................
1,500
50
500
800
1
1
1
1
0.083
0.083
0.04
1
125
4
20
65
.........................................................................
2,850
........................
........................
214
Subtotal .......................
Burden Associated with the Final Rule That Increased the Patient Limit
8.620 (a)–(c) .......................
8.64 .....................................
8.655 ...................................
Request for Patient Limit Increase * ...............
Request for Patient Limit Increase * ...............
Request for Patient Limit Increase * ...............
Renewal Request for a Patient Limit Increase *.
Renewal Request for a Patient Limit Increase *.
Renewal Request for a Patient Limit Increase *.
Request for a Temporary Patient Increase for
an Emergency *.
Request for a Temporary Patient Increase for
an Emergency *.
Request for a Temporary Patient Increase for
an Emergency *.
517
517
517
260
1
1
1
1
0.5
0.5
0.5
0.5
259
259
259
130
260
1
0.5
130
260
1
0.5
130
10
1
3
30
10
1
3
30
10
1
3
30
.........................................................................
2,361
........................
........................
1,256
Subtotal .......................
New Burden Associated with the Final Rule That Outlined the Reporting Requirements
8.635 ...................................
1,350
816
1
1
3
0.066
4,050
54
590
1
0.066
39
590
1
0.066
39
590
1
0.066
39
590
1
0.066
39
Sub Total .....................
Practitioner Reporting Form * .........................
‘‘Qualifying Other Practitioner’’ under 21
U.S.C. 823(g)(2)—Nurse Practitioners.
‘‘Qualifying Other Practitioner’’ under 21
U.S.C. 823(g)(2)—Physician Assistants.
‘‘Qualifying Other Practitioner’’ under 21
U.S.C. 823(g)(2)—Certified Nurse Specialists.
‘‘Qualifying Other Practitioner’’ under 21
U.S.C. 823(g)(2)—Certified Nurse MidWives.
‘‘Qualifying Other Practitioner’’ under 21
U.S.C. 823(g)(2)—Certified Registered
Nurse Anesthetists.
.........................................................................
4,526
........................
........................
4,260
Total Burden .........
.........................................................................
6,561
........................
........................
5,519
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 December 2, 2019.
Summer King,
Statistician.
[FR Doc. 2019–21388 Filed 10–1–19; 8:45 am]
khammond on DSKJM1Z7X2PROD with NOTICES
BILLING CODE 4162–20–P
VerDate Sep<11>2014
16:42 Oct 01, 2019
Jkt 250001
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
PO 00000
Frm 00069
Fmt 4703
Sfmt 4703
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.
E:\FR\FM\02OCN1.SGM
02OCN1
]]>Agencies
[Federal Register Volume 84, Number 191 (Wednesday, October 2, 2019)]
[Notices]
[Pages 52521-52522]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-21388]
-----------------------------------------------------------------------
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 Under 21 U.S.C. 823(g)(2) (OMB No. 0930-0234 and OMB No.
0930-0369)--Revision
The Drug Addiction Treatment Act of 2000 (``DATA,'' Pub. L. 106-
310) amended the Controlled Substances Act (21 U.S.C. 823(g)(2)) to
permit qualifying practitioners to seek and obtain waivers to prescribe
certain approved narcotic treatment drugs for the treatment of opiate
addiction. The legislation set eligibility requirements and
certification requirements as well as an interagency notification
review process for practitioners who seek waivers. To implement these
provisions, SAMHSA developed Notification of Intent Forms that
facilitate the submission and review of notifications. The forms
provide the information necessary to determine whether practitioners
meets the qualifications for waivers set forth under the law at the 30-
, 100-, and 275-patient limits. This includes the annual reporting
requirements for practitioners with waivers for a 275 patient limit. On
October 24, 2018, the Substance Use Disorder Prevention that Promotes
Opioid Recovery and Treatment for Patients and Communities (SUPPORT)
Act (Pub. L. 115-71) was signed into law. Sections 3201-3202 of the
SUPPORT Act made several amendments to the Controlled Substances Act
regarding office-based opioid treatment that affords practitioners
greater flexibility in the provision of medication-assisted treatment
(MAT).
The SUPPORT Act expands the definition of ``qualifying other
practitioner'' enabling Clinical Nurse Specialists, Certified
Registered Nurse Anesthetists, and Certified Nurse Midwives (CNSs,
CRNAs, and CNMs) to apply for a Drug Addiction Treatment Act of 2000
(DATA) waiver until October 1, 2023. It also allows qualified
practitioners (i.e., MDs, DOs, NPs, PAs, CNSs, CRNAs, and CNMs) who are
board certified in addiction medicine or addiction psychiatry, -or-
practitioners who provide MAT in a qualified practice setting, to start
treating up to 100 patients in the first year of MAT practice (as
defined in 42 CFR 8.2) with a waiver.
Further, the SUPPORT Act extends the ability to treat up to 275
patients to ``qualifying other practitioners'' (i.e., NPs, PAs, CNSs,
CRNAs, and CNMs) if they have a waiver to treat up 100 patients for at
least one year and provide medication-assisted treatment with covered
medications (as such terms are defined under 42 CFR 8.2) in a qualified
practice setting as described under 42 CFR 8.615. Finally, the SUPPORT
Act also expands how physicians could qualify for a waiver. Under the
statute now, physicians can qualify for a waiver if they have received
at least 8 hours of training on treating and managing opiate-dependent
patients, as listed in the statute if the physician graduated in good
standing from an accredited school of allopathic medicine or
osteopathic medicine in the United States during the 5-year period
immediately preceding the date on which the physician submits to
SAMHSA. In order to expedite the new provisions of the SUPPORT Act,
SAMHSA sought and received a Public Health Emergency Paperwork
Reduction Act Waiver. Practitioners may use the form for four types of
notifications: (a) New Notification to treat up to 30 patients; (b) New
Notification, with the intent to immediately facilitate treatment of an
individual (one) patient; (c) Second notification of need and intent to
treat up to 100 patients; and (d) New notification to treat up to 100
patients. Under ``new'' notifications, practitioners may make their
initial waiver requests to SAMHSA. ``Immediate'' notifications inform
SAMHSA and the Attorney General of a practitioner's intent to prescribe
immediately to facilitate the treatment of an individual (one) patient
under 21 U.S.C. 823(g)(2)(E)(ii). The form collects data on the
following items: Practitioner name; state medical license number;
medical specialty; and DEA registration number; address of primary
practice location, telephone and fax numbers; email address; name and
address of group practice; group practice employer identification
number; names and DEA registration numbers of group practitioners;
purpose of notification: new, immediate, or renewal; certification of
qualifying criteria for treatment and management of opiate dependent
patients; certification of capacity to provide directly or refer
patients for appropriate counseling and other appropriate ancillary
services; certification of maximum patient load, certification to use
only those drug products that meet the criteria in the law. The form
also notifies practitioners of Privacy Act considerations, and permits
practitioners to expressly consent to disclose limited information to
the SAMHSA Buprenorphine Physician and Behavioral Health Treatment
Services locators. The following table summarizes the estimated annual
burden for the use of this form.
[[Page 52522]]
--------------------------------------------------------------------------------------------------------------------------------------------------------
Estimated Burden/
42 CFR citation Purpose of submission number of Responses/ response Total burden
respondents respondent (hr.) (hrs.)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Notification of Intent............ 1,500 1 0.083 125
Notification to Prescribe 50 1 0.083 4
Immediately.
Notice to Treat up to 100 patients 500 1 0.04 20
Notice to Treat up to 275 patients 800 1 1 65
---------------------------------------------------------------
Subtotal........................................ .................................. 2,850 .............. .............. 214
--------------------------------------------------------------------------------------------------------------------------------------------------------
Burden Associated with the Final Rule That Increased the Patient Limit
--------------------------------------------------------------------------------------------------------------------------------------------------------
8.620 (a)-(c)....................................... Request for Patient Limit Increase 517 1 0.5 259
*.
Request for Patient Limit Increase 517 1 0.5 259
*.
Request for Patient Limit Increase 517 1 0.5 259
*.
8.64................................................ Renewal Request for a Patient 260 1 0.5 130
Limit Increase *.
Renewal Request for a Patient 260 1 0.5 130
Limit Increase *.
Renewal Request for a Patient 260 1 0.5 130
Limit Increase *.
8.655............................................... Request for a Temporary Patient 10 1 3 30
Increase for an Emergency *.
Request for a Temporary Patient 10 1 3 30
Increase for an Emergency *.
Request for a Temporary Patient 10 1 3 30
Increase for an Emergency *.
---------------------------------------------------------------
Subtotal........................................ .................................. 2,361 .............. .............. 1,256
--------------------------------------------------------------------------------------------------------------------------------------------------------
New Burden Associated with the Final Rule That Outlined the Reporting Requirements
--------------------------------------------------------------------------------------------------------------------------------------------------------
8.635............................................... Practitioner Reporting Form *..... 1,350 1 3 4,050
``Qualifying Other Practitioner'' 816 1 0.066 54
under 21 U.S.C. 823(g)(2)--Nurse
Practitioners.
``Qualifying Other Practitioner'' 590 1 0.066 39
under 21 U.S.C. 823(g)(2)--
Physician Assistants.
``Qualifying Other Practitioner'' 590 1 0.066 39
under 21 U.S.C. 823(g)(2)--
Certified Nurse Specialists.
``Qualifying Other Practitioner'' 590 1 0.066 39
under 21 U.S.C. 823(g)(2)--
Certified Nurse Mid-Wives.
``Qualifying Other Practitioner'' 590 1 0.066 39
under 21 U.S.C. 823(g)(2)--
Certified Registered Nurse
Anesthetists.
Sub Total....................................... .................................. 4,526 .............. .............. 4,260
rrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrr
Total Burden................................ .................................. 6,561 .............. .............. 5,519
--------------------------------------------------------------------------------------------------------------------------------------------------------
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 December 2, 2019.
Summer King,
Statistician.
[FR Doc. 2019-21388 Filed 10-1-19; 8:45 am]
BILLING CODE 4162-20-P
