Agency Information Collection Activities: Submission for OMB Review; Comment Request, 66317-66318 [2022-23953]
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Federal Register / Vol. 87, No. 212 / Thursday, November 3, 2022 / Notices
Dated: October 28, 2022.
Miguelina Perez,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2022–23878 Filed 11–2–22; 8:45 am]
BILLING CODE 4140–01–P
National Institutes of Health
National Institute of Allergy and
Infectious Diseases; Notice of Closed
Meeting
lotter on DSK11XQN23PROD with NOTICES1
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended, notice is hereby given of the
following meeting.
The meeting will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The grant applications and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: National Institute of
Allergy and Infectious Diseases Special
Emphasis Panel; Centers for AIDS Research
(P30 Clinical Trial Not Allowed);
Developmental Centers for AIDS Research
(P30 Clinical Trial Not Allowed).
Date: December 5–6, 2022.
Time: 10:00 a.m. to 2:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institute of Allergy and
Infectious Diseases, National Institutes of
Health, 5601 Fishers Lane, Room 3G31,
Rockville, MD 20892 (Virtual Meeting).
Contact Person: Cynthia L. De La Fuente,
Ph.D., Scientific Review Officer, Scientific
Review Program, Division of Extramural
Activities, National Institute of Allergy and
Infectious Diseases, National Institutes of
Health, 5601 Fishers Lane, Room 3G31,
Rockville, MD 20852, 240–669–2740,
delafuentecl@niaid.nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.855, Allergy, Immunology,
and Transplantation Research; 93.856,
Microbiology and Infectious Diseases
Research, National Institutes of Health, HHS)
Dated: October 28, 2022.
Tyeshia M. Roberson-Curtis,
Program Analyst, Office of Federal Advisory
Committee Policy.
BILLING CODE 4140–01–P
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16:41 Nov 02, 2022
Jkt 259001
Substance Abuse and Mental Health
Services Administration
Agency Information Collection
Activities: Submission for OMB
Review; Comment Request
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
[FR Doc. 2022–23897 Filed 11–2–22; 8:45 am]
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
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
Paperwork Reduction Act (44 U.S.C.
chapter 35). To request a copy of these
documents, call the SAMHSA Reports
Clearance Officer on (240) 276–0361.
Project: Notification of Intent To Use
Schedule III, IV, or V Controlled
Medications for the Treatment of
Opioid Use Disorder 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 controlled medications for the
treatment of opioid use disorder. The
legislation set eligibility 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 meet the
qualifications for waivers set forth
under the law at the 30-, 100-, and 275patient 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 use disorder treatment that
affords practitioners greater flexibility in
the provision of Medications for Opioid
Use Disorder (MOUD).
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
PO 00000
Frm 00061
Fmt 4703
Sfmt 4703
66317
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 MOUD in a qualified
practice setting, to start treating up to
100 patients in the first year of 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 treatment of
Opioid Use Disorder 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
patients with opioid use disorder, 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 a Notice of
Intent 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.
On April 28, 2021 the Department of
Health and Human Services (HHS)
issued the new Practice Guidelines for
the Administration of Buprenorphine
for Treating Opioid Use Disorder (86 FR
22439) in an expedited manner. The
Practice Guidelines allow practitioners
who wish to obtain a 30-patient waiver
to forego the 8-hour training
requirement for physicians and 24-hour
training for other qualifying
practitioners. Practitioners utilizing this
training exemption are limited to
treating no more than 30-patients at a
time and time spent practicing under
this exemption will not qualify the
practitioner to qualify for a higher
patient level. In addition, the new
Practice Guidelines removed the
requirement to provide counseling and
other ancillary services (i.e.,
psychosocial services).
The collection of information within
the application is essential to the
implementation of SAMHSA’s mission
to reduce the impact of substance use
disorders on America’s communities.
Practitioners may use these forms for
various types of notifications: (a) New
E:\FR\FM\03NON1.SGM
03NON1
66318
Federal Register / Vol. 87, No. 212 / Thursday, November 3, 2022 / Notices
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; (d) New notification
to treat up to 100 patients, and (e) New
notification to treat up to 275 patients.
Under ‘‘new’’ notifications, practitioners
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
42 CFR citation
Subtotal ..................
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 patients with opioid use disorder;
certification of capacity to provide
directly or refer patients for appropriate
Estimated
number of
respondents
Purpose of submission
counseling and other appropriate
ancillary services; certification of
maximum patient load, certification to
use only those medication formulations
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 these forms.
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 .......................
1,800
60
600
960
1
1
1
1
0.083
0.083
0.04
0.081
149
5
24
78
..............................................................................
3,420
........................
........................
256
Burden Associated With the Final Rule That Increased the Patient Limit
8.620 (a)–(c) ..................
8.64 ...............................
8.655 .............................
Subtotal ..................
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 *.
620
620
620
312
312
312
12
1
1
1
1
1
1
1
0.5
0.5
0.5
0.5
0.5
0.5
3
310
310
310
156
156
156
36
12
1
3
36
12
1
3
36
..............................................................................
2,497
........................
........................
1,279
Burden Associated With the Final Rule That Outlined the Reporting Requirements
lotter on DSK11XQN23PROD with NOTICES1
8.635 .............................
Practitioner Reporting Form * ...............................
‘‘Qualifying Other Practitioner’’ under 21 USC
§ 823(g)(2)—Nurse Practitioners.
‘‘Qualifying Other Practitioner’’ under 21 USC
§ 823(g)(2)—Physician Assistants.
‘‘Qualifying Other Practitioner’’ under 21 USC
§ 823(g)(2)—Certified Nurse Specialists.
‘‘Qualifying Other Practitioner’’ under 21 USC
§ 823(g)(2)—Certified Nurse Mid-Wives.
‘‘Qualifying Other Practitioner’’ under 21 USC
§ 823(g)(2)—Certified Registered Nurse Anesthetists.
1,620
979
........................
1
3
0.066
4860
65
708
1
0.066
47
708
1
0.066
47
708
1
0.066
47
708
1
0.066
47
Sub Total ................
..............................................................................
5,431
1
........................
5112
Total Burden ...
..............................................................................
6,561
........................
........................
6,647
Written comments and
recommendations for the proposed
information collection should be sent
within 30 days of publication of this
notice to www.reginfo.gov/public/do/
PRAMain. Find this particular
information collection by selecting
‘‘Currently under 30-day Review—Open
for Public Comments’’ or by using the
search function.
Alicia Broadus,
Public Health Advisor.
[FR Doc. 2022–23953 Filed 11–2–22; 8:45 am]
BILLING CODE 4162–20–P
VerDate Sep<11>2014
16:41 Nov 02, 2022
Jkt 259001
PO 00000
Frm 00062
Fmt 4703
Sfmt 9990
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]]>Agencies
[Federal Register Volume 87, Number 212 (Thursday, November 3, 2022)]
[Notices]
[Pages 66317-66318]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-23953]
-----------------------------------------------------------------------
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 Paperwork
Reduction Act (44 U.S.C. chapter 35). To request a copy of these
documents, call the SAMHSA Reports Clearance Officer on (240) 276-0361.
Project: Notification of Intent To Use Schedule III, IV, or V
Controlled Medications for the Treatment of Opioid Use Disorder 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 controlled medications for the treatment of opioid use
disorder. The legislation set eligibility 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 meet 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 use disorder treatment that affords practitioners
greater flexibility in the provision of Medications for Opioid Use
Disorder (MOUD).
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 MOUD in a qualified practice setting, to
start treating up to 100 patients in the first year of 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
treatment of Opioid Use Disorder 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 patients with opioid use
disorder, 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 a Notice
of Intent 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.
On April 28, 2021 the Department of Health and Human Services (HHS)
issued the new Practice Guidelines for the Administration of
Buprenorphine for Treating Opioid Use Disorder (86 FR 22439) in an
expedited manner. The Practice Guidelines allow practitioners who wish
to obtain a 30-patient waiver to forego the 8-hour training requirement
for physicians and 24-hour training for other qualifying practitioners.
Practitioners utilizing this training exemption are limited to treating
no more than 30-patients at a time and time spent practicing under this
exemption will not qualify the practitioner to qualify for a higher
patient level. In addition, the new Practice Guidelines removed the
requirement to provide counseling and other ancillary services (i.e.,
psychosocial services).
The collection of information within the application is essential
to the implementation of SAMHSA's mission to reduce the impact of
substance use disorders on America's communities. Practitioners may use
these forms for various types of notifications: (a) New
[[Page 66318]]
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; (d) New notification to treat up to 100 patients, and (e) New
notification to treat up to 275 patients. Under ``new'' notifications,
practitioners 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 patients with opioid use disorder;
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
medication formulations 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 these forms.
----------------------------------------------------------------------------------------------------------------
Estimated
42 CFR citation Purpose of number of Responses/ Burden/ Total burden
submission respondents respondent response (hr.) (hrs.)
----------------------------------------------------------------------------------------------------------------
Notification of 1,800 1 0.083 149
Intent.
Notification to 60 1 0.083 5
Prescribe
Immediately.
Notice to Treat 600 1 0.04 24
up to 100
patients.
Notice to Treat 960 1 0.081 78
up to 275
patients.
---------------------------------------------------------------
Subtotal.................. ................ 3,420 .............. .............. 256
----------------------------------------------------------------------------------------------------------------
Burden Associated With the Final Rule That Increased the Patient Limit
----------------------------------------------------------------------------------------------------------------
8.620 (a)-(c)................. Request for 620 1 0.5 310
Patient Limit
Increase *.
Request for 620 1 0.5 310
Patient Limit
Increase *.
Request for 620 1 0.5 310
Patient Limit
Increase *.
8.64.......................... Renewal Request 312 1 0.5 156
for a Patient
Limit Increase
*.
Renewal Request 312 1 0.5 156
for a Patient
Limit Increase
*.
Renewal Request 312 1 0.5 156
for a Patient
Limit Increase
*.
8.655......................... Request for a 12 1 3 36
Temporary
Patient
Increase for an
Emergency *.
Request for a 12 1 3 36
Temporary
Patient
Increase for an
Emergency *.
Request for a 12 1 3 36
Temporary
Patient
Increase for an
Emergency *.
---------------------------------------------------------------
Subtotal.................. ................ 2,497 .............. .............. 1,279
----------------------------------------------------------------------------------------------------------------
Burden Associated With the Final Rule That Outlined the Reporting Requirements
----------------------------------------------------------------------------------------------------------------
8.635......................... Practitioner 1,620 .............. 3 4860
Reporting Form
*.
``Qualifying 979 1 0.066 65
Other
Practitioner''
under 21 USC
Sec.
823(g)(2)--Nurs
e Practitioners.
``Qualifying 708 1 0.066 47
Other
Practitioner''
under 21 USC
Sec.
823(g)(2)--Phys
ician
Assistants.
``Qualifying 708 1 0.066 47
Other
Practitioner''
under 21 USC
Sec.
823(g)(2)--Cert
ified Nurse
Specialists.
``Qualifying 708 1 0.066 47
Other
Practitioner''
under 21 USC
Sec.
823(g)(2)--Cert
ified Nurse Mid-
Wives.
``Qualifying 708 1 0.066 47
Other
Practitioner''
under 21 USC
Sec.
823(g)(2)--Cert
ified
Registered
Nurse
Anesthetists.
---------------------------------------------------------------
Sub Total................. ................ 5,431 1 .............. 5112
---------------------------------------------------------------
Total Burden.......... ................ 6,561 .............. .............. 6,647
----------------------------------------------------------------------------------------------------------------
Written comments and recommendations for the proposed information
collection should be sent within 30 days of publication of this notice
to www.reginfo.gov/public/do/PRAMain. Find this particular information
collection by selecting ``Currently under 30-day Review--Open for
Public Comments'' or by using the search function.
Alicia Broadus,
Public Health Advisor.
[FR Doc. 2022-23953 Filed 11-2-22; 8:45 am]
BILLING CODE 4162-20-P
