Agency Information Collection Activities: Submission for OMB Review; Comment Request, 22438-22439 [2021-08796]
Download as PDF
<![CDATA[
22438
Federal Register / Vol. 86, No. 80 / Wednesday, April 28, 2021 / Notices
as trustee, both of Leawood, Kansas;
and the Bruce L. Bachman Trust for
Tyler J. Bachman, Tyler J. Bachman, as
trustee, both of Shawnee, Kansas; to join
the Bachman Family Control Group, a
group acting in concert, to retain voting
shares of First Centralia Bancshares,
Inc., and thereby indirectly retain voting
shares of First Heritage Bank, both of
Centralia, Kansas.
Board of Governors of the Federal Reserve
System, April 23, 2021.
Michele Taylor Fennell,
Deputy Associate Secretary of the Board.
[FR Doc. 2021–08872 Filed 4–27–21; 8:45 am]
BILLING CODE P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Medicare & Medicaid
Services
[Document Identifier: CMS–10326 and CMS–
10340]
Agency Information Collection
Activities: Submission for OMB
Review; Comment Request
Centers for Medicare &
Medicaid Services, Health and Human
Services (HHS).
ACTION: Notice.
AGENCY:
The Centers for Medicare &
Medicaid Services (CMS) is announcing
an opportunity for the public to
comment on CMS’ intention to collect
information from the public. Under the
Paperwork Reduction Act of 1995
(PRA), federal agencies are required to
publish notice in the Federal Register
concerning each proposed collection of
information, including each proposed
extension or reinstatement of an existing
collection of information, and to allow
a second opportunity for public
comment on the notice. Interested
persons are invited to send comments
regarding the burden estimate or any
other aspect of this collection of
information, including the necessity and
utility of the proposed information
collection for the proper performance of
the agency’s functions, the accuracy of
the estimated burden, ways to enhance
the quality, utility, and clarity of the
information to be collected, and the use
of automated collection techniques or
other forms of information technology to
minimize the information collection
burden. April 28, 2021.
DATES: Comments on the collection(s) of
information must be received by the
OMB desk officer by May 28, 2021.
ADDRESSES: Written comments and
recommendations for the proposed
jbell on DSKJLSW7X2PROD with NOTICES
SUMMARY:
VerDate Sep<11>2014
19:17 Apr 27, 2021
Jkt 253001
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.
To obtain copies of a supporting
statement and any related forms for the
proposed collection(s) summarized in
this notice, you may make your request
using one of following:
1. Access CMS’ website address at
website address at: https://
www.cms.gov/Regulations-andGuidance/Legislation/
PaperworkReductionActof1995/PRAListing.html.
FOR FURTHER INFORMATION CONTACT:
William Parham at (410) 786–4669.
SUPPLEMENTARY INFORMATION: Under the
Paperwork Reduction Act of 1995 (PRA)
(44 U.S.C. 3501–3520), federal agencies
must obtain approval from the Office of
Management and Budget (OMB) for each
collection of information they conduct
or sponsor. The term ‘‘collection of
information’’ is defined in 44 U.S.C.
3502(3) and 5 CFR 1320.3(c) and
includes agency requests or
requirements that members of the public
submit reports, keep records, or provide
information to a third party. Section
3506(c)(2)(A) of the PRA (44 U.S.C.
3506(c)(2)(A)) requires federal agencies
to publish a 30-day notice in the
Federal Register concerning each
proposed collection of information,
including each proposed extension or
reinstatement of an existing collection
of information, before submitting the
collection to OMB for approval. To
comply with this requirement, CMS is
publishing this notice that summarizes
the following proposed collection(s) of
information for public comment:
1. Type of Information Collection
Request: Reinstatement without change
of a currently approved collection; Title
of Information Collection: Electronic
Submission of Medicare Graduate
Medical Education (GME) Affiliation
Agreements; Use: Existing regulations at
§ 413.75(b) permit hospitals that share
residents to elect to form a Medicare
GME affiliated group if they are in the
same or contiguous urban or rural areas,
if they are under common ownership, or
if they are jointly listed as program
sponsors or major participating
institutions in the same program by the
accrediting agency. The purpose of a
Medicare GME affiliated group is to
provide flexibility to hospitals in
structuring rotations under an aggregate
full time equivalent (FTE) resident cap
when they share residents. The existing
PO 00000
Frm 00055
Fmt 4703
Sfmt 4703
regulations at § 413.79(f)(1) specify that
each hospital in a Medicare GME
affiliated group must submit a Medicare
GME affiliation agreement (as defined
under § 413.75(b)) to the Medicare
Administrative Contractor (MAC)
servicing the hospital and send a copy
to the Centers for Medicare and
Medicaid Services’ (CMS) Central
Office, no later than July 1 of the
residency program year during which
the Medicare GME affiliation agreement
will be in effect.
CMS will use the information
contained in electronic affiliation
agreements as documentation of the
existence of Medicare GME affiliations,
and to verify that the affiliations being
formed by teaching hospitals for the
purposes of sharing their Medicare GME
FTE cap slots are valid according to
CMS regulations. CMS will also use
these affiliation agreements as reference
materials when potential issues
involving specific affiliations arise.
While we have used hard copies of
affiliation agreements for those same
purposes in the past, we implemented
this electronic submission process in
order to expedite and ease the process
of retrieving, analyzing and evaluating
affiliation agreements. Form Number:
CMS–10326 (OMB control number:
0938–1111); Frequency: Annually;
Affected Public: Private Sector, Business
or other for profits, Not for profit
institutions; Number of Respondents:
125; Total Annual Responses: 125; Total
Annual Hours: 166. (For policy
questions regarding this collection
contact Shevi Marciano at 410–786–
2874.)
2. Type of Information Collection
Request: Revision of a currently
approved collection; Title of
Information Collection: Collection of
Encounter Data from MA Organizations
Use: Section 1853(a)(3)(B) of the Act
directs CMS to require MA
organizations and eligible organizations
with risk-sharing contracts under 1876
to ‘‘submit data regarding inpatient
hospital services . . . and data
regarding other services and other
information as the Secretary deems
necessary’’ in order to implement a
methodology for ‘‘risk adjusting’’
payments made to MA organizations
and other entities. Risk adjustments to
enrollee monthly payments are made in
order to take into account ‘‘variations in
per capita costs based on [the] health
status’’ of the Medicare beneficiaries
enrolled in an MA plan.
CMS collects encounter data for
beneficiaries enrolled in MA
organizations, section 1876 Cost Health
Maintenance Organizations (HMOs)/
Competitive Medical Plans (CMPs),
E:\FR\FM\28APN1.SGM
28APN1
Federal Register / Vol. 86, No. 80 / Wednesday, April 28, 2021 / Notices
Programs of All-inclusive Care for the
Elderly (PACE) organizations, and
MMPs. For PACE organizations and
MMPs, encounter data serves essentially
the same purposes as it does for the MA
program (for Part C and Part D risk
adjustment). To 1876 Cost Plans that
offer Part D coverage, CMS makes risk
adjusted, capitated monthly payments
for Part D.
MA organizations, Part D
organizations, 1876 Cost Plans, MMPs
and PACE organizations must use a
CMS approved Network Service Vendor
to establish connectivity with the CMS
secure network for operational
purposes. Once connectivity is
established, these entities must submit
required documents to CMS’s front-end
contractor to obtain security access
credentials. Form Number: CMS–10340
(OMB control number: 0938–1152);
Frequency: Annually; Affected Public:
Private Sector, Business or other forprofits, Not-for-profits institutions;
Number of Respondents: 733; Total
Annual Responses: 1,068,204,429; Total
Annual Hours: 35,618,366. (For policy
questions regarding this collection
contact Michael P. Massimini at 410–
786–1560.)
Dated: April 22, 2021.
William N. Parham, III,
Director, Paperwork Reduction Staff, Office
of Strategic Operations and Regulatory
Affairs.
[FR Doc. 2021–08796 Filed 4–27–21; 8:45 am]
BILLING CODE 4120–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Practice Guidelines for the
Administration of Buprenorphine for
Treating Opioid Use Disorder
Office of the Secretary,
Department of Health and Human
Services.
ACTION: Notice.
AGENCY:
The Practice Guidelines for
the Administration of Buprenorphine
for Treating Opioid Use Disorder
provides eligible physicians, physician
assistants, nurse practitioners, clinical
nurse specialists, certified registered
nurse anesthetists, and certified nurse
midwives, who are state licensed and
registered by the DEA to prescribe
controlled substances, an exemption
from certain statutory certification
requirements related to training,
counseling and other ancillary services
(i.e., psychosocial services).
DATES: This guidance takes effect April
28, 2021.
jbell on DSKJLSW7X2PROD with NOTICES
SUMMARY:
VerDate Sep<11>2014
19:17 Apr 27, 2021
Jkt 253001
FOR FURTHER INFORMATION CONTACT:
Neeraj Gandotra MD, Chief Medical
Officer, Substance Abuse Mental Health
Services Administration, 5600 Fishers
Lane 18E67, Rockville, MD 20857,
neeraj.gandotra@samhsa.hhs.gov.
SUPPLEMENTARY INFORMATION:
A. Background
The Drug Addiction Treatment Act of
2000 (DATA 2000), which amended the
Controlled Substances Act (CSA), was
passed in order to improve access to
treatment for Opioid Use Disorder
(OUD) by allowing practitioners to
prescribe approved Schedule III through
V medications for OUD treatment
without the need to hold a separate
registration for this purpose. The CSA
permits qualified practitioners to
dispense certain opioid treatment
medications for the treatment of OUD.
Addressing the perceived barriers
around prescribing buprenorphine by
exempting practitioners from the
certification requirements related to
training, counseling and other ancillary
services (i.e., psychosocial services),
may increase the availability of
Medication-based Opioid Use Disorder
Treatment (MOUD), and help address
barriers to care for OUD.
Buprenorphine, an FDA-approved
medication for opioid use disorder, is an
opioid partial agonist that produces
effects such as euphoria or respiratory
depression at low to moderate doses.
However, these effects are weaker than
full opioid agonists such as methadone
and heroin. Given these properties
confer a lower diversion risk,
buprenorphine prescriptions are
preferable to other medications in the
office based setting.
B. Purpose of the Practice Guidelines
Under certain conditions, the attached
Practice Guidelines exempt eligible
physicians, physician assistants, nurse
practitioners, clinical nurse specialists,
certified registered nurse anesthetists,
and certified nurse midwives
(hereinafter collectively referred to as
‘‘practitioners’’), from the certification
requirements related to training,
counseling and other ancillary services
(i.e., psychosocial services) under 21
U.S.C. 823(g)(2)(B)(i)–(ii). This action is
needed in order to expand access to
buprenorphine for opioid use disorder
treatment. Specifically, the exemption
allows these practitioners to treat up to
30 patients with OUD using
buprenorphine without having to make
certain training related certifications.
This exemption also allows
practitioners to treat patients with
buprenorphine without certifying as to
their capacity to provide counseling and
PO 00000
Frm 00056
Fmt 4703
Sfmt 4703
22439
ancillary services. This exemption
specifically addresses reported barriers
of the training requirement. Providers
are still required to submit an
application designated as a ‘‘Notice of
Intent’’ in order to prescribe
buprenorphine for the treatment of
Opioid Use Disorder.
C. Authority: 21 U.S.C.
823(g)(2)(H)(i)(II)
Practice Guidelines for the
Administration of Buprenorphine for
Treating Opioid Use Disorder
Pursuant to 21 U.S.C.
823(g)(2)(H)(i)(II), the Department of
Health and Human Services (HHS),
issues these practice guidelines
regarding the eligibility of physicians,
physician assistants, nurse practitioners,
clinical nurse specialists, certified
registered nurse anesthetists, and
certified nurse midwives (hereinafter
collectively referred to as
‘‘practitioners’’) for a waiver under 21
U.S.C. 823(g)(2).
The United States faces an opioid
overdose epidemic that has engendered
a public health crisis and prematurely
ended thousands of American lives. For
the year ending in August 2020,
provisional data from the Centers for
Disease Control and Prevention show
that overdose deaths have increased
26.8 percent compared to the previous
12 months, to more than 88,000 deaths.
These deaths disproportionately affect
working Americans with families, with
the highest rates of opioid overdose
deaths occurring in individuals between
the ages of 25 and 54. Those who
succumb to overdose leave spouses
without partners, children without
parents, and parents without children.
Medication-based treatment for
opioid-use disorder (OUD), as part of a
comprehensive treatment plan that may
also include counseling and behavioral
therapies, is an effective approach that
can sustain recovery and prevent
overdose. In order for a practitioner to
dispense (including prescribe)
buprenorphine for OUD, the practitioner
must satisfy the requirements of 21
U.S.C. 823(g)(1) or 823(g)(2). Under
§ 823(g)(1), ‘‘practitioners who dispense
narcotic drugs to individuals for
maintenance treatment or detoxification
treatment shall obtain annually a
separate [DEA] registration for that
purpose.’’ The ‘‘Attorney General shall
register an applicant to dispense
narcotic drugs to individuals for
maintenance treatment or detoxification
treatment (or both).’’ See 21 U.S.C.
823(g)(1).
Alternatively, a practitioner may seek
a waiver from this registration
E:\FR\FM\28APN1.SGM
28APN1
]]>Agencies
[Federal Register Volume 86, Number 80 (Wednesday, April 28, 2021)]
[Notices]
[Pages 22438-22439]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-08796]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
[Document Identifier: CMS-10326 and CMS-10340]
Agency Information Collection Activities: Submission for OMB
Review; Comment Request
AGENCY: Centers for Medicare & Medicaid Services, Health and Human
Services (HHS).
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Centers for Medicare & Medicaid Services (CMS) is
announcing an opportunity for the public to comment on CMS' intention
to collect information from the public. Under the Paperwork Reduction
Act of 1995 (PRA), federal agencies are required to publish notice in
the Federal Register concerning each proposed collection of
information, including each proposed extension or reinstatement of an
existing collection of information, and to allow a second opportunity
for public comment on the notice. Interested persons are invited to
send comments regarding the burden estimate or any other aspect of this
collection of information, including the necessity and utility of the
proposed information collection for the proper performance of the
agency's functions, the accuracy of the estimated burden, ways to
enhance the quality, utility, and clarity of the information to be
collected, and the use of automated collection techniques or other
forms of information technology to minimize the information collection
burden. April 28, 2021.
DATES: Comments on the collection(s) of information must be received by
the OMB desk officer by May 28, 2021.
ADDRESSES: 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.
To obtain copies of a supporting statement and any related forms
for the proposed collection(s) summarized in this notice, you may make
your request using one of following:
1. Access CMS' website address at website address at: https://www.cms.gov/Regulations-and-Guidance/Legislation/PaperworkReductionActof1995/PRA-Listing.html.
FOR FURTHER INFORMATION CONTACT: William Parham at (410) 786-4669.
SUPPLEMENTARY INFORMATION: Under the Paperwork Reduction Act of 1995
(PRA) (44 U.S.C. 3501-3520), federal agencies must obtain approval from
the Office of Management and Budget (OMB) for each collection of
information they conduct or sponsor. The term ``collection of
information'' is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3(c) and
includes agency requests or requirements that members of the public
submit reports, keep records, or provide information to a third party.
Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) requires
federal agencies to publish a 30-day notice in the Federal Register
concerning each proposed collection of information, including each
proposed extension or reinstatement of an existing collection of
information, before submitting the collection to OMB for approval. To
comply with this requirement, CMS is publishing this notice that
summarizes the following proposed collection(s) of information for
public comment:
1. Type of Information Collection Request: Reinstatement without
change of a currently approved collection; Title of Information
Collection: Electronic Submission of Medicare Graduate Medical
Education (GME) Affiliation Agreements; Use: Existing regulations at
Sec. 413.75(b) permit hospitals that share residents to elect to form
a Medicare GME affiliated group if they are in the same or contiguous
urban or rural areas, if they are under common ownership, or if they
are jointly listed as program sponsors or major participating
institutions in the same program by the accrediting agency. The purpose
of a Medicare GME affiliated group is to provide flexibility to
hospitals in structuring rotations under an aggregate full time
equivalent (FTE) resident cap when they share residents. The existing
regulations at Sec. 413.79(f)(1) specify that each hospital in a
Medicare GME affiliated group must submit a Medicare GME affiliation
agreement (as defined under Sec. 413.75(b)) to the Medicare
Administrative Contractor (MAC) servicing the hospital and send a copy
to the Centers for Medicare and Medicaid Services' (CMS) Central
Office, no later than July 1 of the residency program year during which
the Medicare GME affiliation agreement will be in effect.
CMS will use the information contained in electronic affiliation
agreements as documentation of the existence of Medicare GME
affiliations, and to verify that the affiliations being formed by
teaching hospitals for the purposes of sharing their Medicare GME FTE
cap slots are valid according to CMS regulations. CMS will also use
these affiliation agreements as reference materials when potential
issues involving specific affiliations arise. While we have used hard
copies of affiliation agreements for those same purposes in the past,
we implemented this electronic submission process in order to expedite
and ease the process of retrieving, analyzing and evaluating
affiliation agreements. Form Number: CMS-10326 (OMB control number:
0938-1111); Frequency: Annually; Affected Public: Private Sector,
Business or other for profits, Not for profit institutions; Number of
Respondents: 125; Total Annual Responses: 125; Total Annual Hours: 166.
(For policy questions regarding this collection contact Shevi Marciano
at 410-786-2874.)
2. Type of Information Collection Request: Revision of a currently
approved collection; Title of Information Collection: Collection of
Encounter Data from MA Organizations Use: Section 1853(a)(3)(B) of the
Act directs CMS to require MA organizations and eligible organizations
with risk-sharing contracts under 1876 to ``submit data regarding
inpatient hospital services . . . and data regarding other services and
other information as the Secretary deems necessary'' in order to
implement a methodology for ``risk adjusting'' payments made to MA
organizations and other entities. Risk adjustments to enrollee monthly
payments are made in order to take into account ``variations in per
capita costs based on [the] health status'' of the Medicare
beneficiaries enrolled in an MA plan.
CMS collects encounter data for beneficiaries enrolled in MA
organizations, section 1876 Cost Health Maintenance Organizations
(HMOs)/Competitive Medical Plans (CMPs),
[[Page 22439]]
Programs of All-inclusive Care for the Elderly (PACE) organizations,
and MMPs. For PACE organizations and MMPs, encounter data serves
essentially the same purposes as it does for the MA program (for Part C
and Part D risk adjustment). To 1876 Cost Plans that offer Part D
coverage, CMS makes risk adjusted, capitated monthly payments for Part
D.
MA organizations, Part D organizations, 1876 Cost Plans, MMPs and
PACE organizations must use a CMS approved Network Service Vendor to
establish connectivity with the CMS secure network for operational
purposes. Once connectivity is established, these entities must submit
required documents to CMS's front-end contractor to obtain security
access credentials. Form Number: CMS-10340 (OMB control number: 0938-
1152); Frequency: Annually; Affected Public: Private Sector, Business
or other for-profits, Not-for-profits institutions; Number of
Respondents: 733; Total Annual Responses: 1,068,204,429; Total Annual
Hours: 35,618,366. (For policy questions regarding this collection
contact Michael P. Massimini at 410-786-1560.)
Dated: April 22, 2021.
William N. Parham, III,
Director, Paperwork Reduction Staff, Office of Strategic Operations and
Regulatory Affairs.
[FR Doc. 2021-08796 Filed 4-27-21; 8:45 am]
BILLING CODE 4120-01-P
