Agency Information Collection Activities: Submission for OMB Review; Comment Request, 80723-80724 [2023-25601]
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Federal Register / Vol. 88, No. 222 / Monday, November 20, 2023 / Notices
concert, to acquire voting shares of
Hutsonville Banc Corp., and thereby
indirectly acquire voting shares of
Farmers & Merchants Bank of
Hutsonville, both of Hutsonville,
Illinois.
B. Federal Reserve Bank of Kansas
City (Jeffrey Imgarten, Assistant Vice
President) One Memorial Drive, Kansas
City, Missouri 64198. Comments can
also be sent electronically to
KCApplicationComments@kc.frb.org:
1. Jeanette Postier and Stephen
Postier, both of York, Nebraska; to
become members of the Postier Family
Group, a group acting in concert, to
acquire additional voting shares of
Henderson State Company, and thereby
indirectly acquire additional voting
shares of Henderson State Bank, both of
Henderson, Nebraska.
Board of Governors of the Federal Reserve
System.
Michele Taylor Fennell,
Deputy Associate Secretary of the Board.
[FR Doc. 2023–25617 Filed 11–17–23; 8:45 am]
BILLING CODE P
with the standards of section 4 of the
BHC Act.
Unless otherwise noted, comments
regarding the applications must be
received at the Reserve Bank indicated
or the offices of the Board of Governors,
Ann E. Misback, Secretary of the Board,
20th Street and Constitution Avenue
NW, Washington, DC 20551–0001, not
later than December 5, 2023.
A. Federal Reserve Bank of Dallas
(Karen Smith, Director, Mergers &
Acquisitions) 2200 North Pearl Street,
Dallas, Texas 75201–2272. Comments
can also be sent electronically to
Comments.applications@dal.frb.org:
1. First New Mexico Financial
Corporation, Deming, New Mexico; to
engage de novo through its subsidiaries,
ArmsLength, LLC, and Five Seven Five,
LLC, both of Deming, New Mexico, in
extending credit and servicing loans
pursuant to section 225.28(b)(1) of the
Board’s Regulation Y.
Board of Governors of the Federal Reserve
System.
Michele Taylor Fennell,
Deputy Associate Secretary of the Board.
ddrumheller on DSK120RN23PROD with NOTICES1
[FR Doc. 2023–25613 Filed 11–17–23; 8:45 am]
80723
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.
Comments on the collection(s) of
information must be received by the
OMB desk officer by December 20, 2023.
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, please access the CMS PRA
website by copying and pasting the
following web address into your web
browser: https://www.cms.gov/
Regulations-and-Guidance/Legislation/
PaperworkReductionActof1995/PRAListing.
DATES:
FEDERAL RESERVE SYSTEM
BILLING CODE P
Notice of Proposals To Engage in or
To Acquire Companies Engaged in
Permissible Nonbanking Activities
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
FOR FURTHER INFORMATION CONTACT:
Centers for Medicare & Medicaid
Services
SUPPLEMENTARY INFORMATION:
The companies listed in this notice
have given notice under section 4 of the
Bank Holding Company Act (12 U.S.C.
1843) (BHC Act) and Regulation Y, (12
CFR part 225) to engage de novo, or to
acquire or control voting securities or
assets of a company, including the
companies listed below, that engages
either directly or through a subsidiary or
other company, in a nonbanking activity
that is listed in § 225.28 of Regulation Y
(12 CFR 225.28) or that the Board has
determined by Order to be closely
related to banking and permissible for
bank holding companies. Unless
otherwise noted, these activities will be
conducted throughout the United States.
The public portions of the
applications listed below, as well as
other related filings required by the
Board, if any, are available for
immediate inspection at the Federal
Reserve Bank(s) indicated below and at
the offices of the Board of Governors.
This information may also be obtained
on an expedited basis, upon request, by
contacting the appropriate Federal
Reserve Bank and from the Board’s
Freedom of Information Office at
https://www.federalreserve.gov/foia/
request.htm. Interested persons may
express their views in writing on the
question whether the proposal complies
VerDate Sep<11>2014
17:42 Nov 17, 2023
Jkt 262001
[Document Identifier: CMS–10390 and CMS–
10865]
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
SUMMARY:
PO 00000
Frm 00037
Fmt 4703
Sfmt 4703
William Parham at (410) 786–4669.
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: Extension of a currently
approved collection; Title of
Information Collection: Hospice Quality
Reporting Program; Use: On July 1,
2014, hospices began using a newly
created data collection instrument,
E:\FR\FM\20NON1.SGM
20NON1
ddrumheller on DSK120RN23PROD with NOTICES1
80724
Federal Register / Vol. 88, No. 222 / Monday, November 20, 2023 / Notices
titled the ‘‘Hospice Item Set’’ (HIS)
V1.00.0. The HIS is used for the
collection of quality measure data
related to the Hospice Quality Reporting
Program (HQRP), and the HIS V1.00.0
specified the collection of data items
that supported seven Consensus Based
Entity (CBE) endorsed Quality Measures
(QMs) for hospice. On April 1, 2017,
hospices began using an updated HIS
V2.00.0, which includes the same items
from the HIS V1.00.0 along with the
addition of several new items for use in
new measures, measure refinement,
patient record matching, and future
public reporting. Data collected from the
HIS are used to calculate the seven CBEendorsed QMs and the CBE-endorsed
Hospice and Palliative Care Composite
Process Measure—Comprehensive
Assessment at Admission QM.
During the FY 2021 rule, the Hospice
Visits when Death is Imminent measure
pair was removed and replaced with the
claims-based Hospice Visits in Last
Days of Life (HVLDL) measure. The
reduction in provider burden and costs
occurred when CMS replaced the HISbased HVWDII quality measure via the
HIS information collection request that
OMB approved on February 16, 2021.
CMS is requesting to extend the
expiration date. The HIS V3.00.0
consists of data elements that are
designed to collect standardized,
patient-level data for the following
domains of care: pain, respiratory status,
medications, patient preferences and
beliefs and values. The HIS V3.00.0 was
developed specifically for use by
hospices and contains data elements
that we can use to collect patient-level
data to calculate eight CBE endorsed
quality measures. Form Number: CMS–
10390 (OMB control number: 0938–
1153); Frequency: On Occasion;
Affected Public: State, Local, or Tribal
Governments, Private Sector (not-forprofit institutions); individuals or
households; Number of Respondents:
5,640; Total Annual Responses:
2,763,850; Total Annual Hours:
1,323,883. (For policy questions
regarding this collection contact
Jermama Keys at (410) 786–7778.)
2. Type of Information Collection
Request: New collection (Request for a
new OMB control number); Title of
Information Collection: Monoclonal
Antibodies Directed Against Amyloid
for the Treatment of Alzheimer’s
Disease; Use: On April 7, 2022, CMS
finalized the national coverage
determination (NCD) to cover FDA
approved monoclonal antibodies
(mAbs) directed against amyloid for the
treatment of Alzheimer’s disease (AD)
under coverage with evidence
development (CED) in patients who
VerDate Sep<11>2014
17:42 Nov 17, 2023
Jkt 262001
have a clinical diagnosis of mild
cognitive impairment (MCI) due to AD
or mild AD dementia, both with
confirmed presence of amyloid beta
pathology consistent with AD. For antiamyloid mAbs that have accelerated
approval, the mAb may be covered in a
randomized controlled trial conducted
under an investigational new drug (IND)
application or any NIH sponsored trial.
For antiamyloid mAbs that have
traditional FDA approval (as opposed to
accelerated approval), the NCD specifies
coverage under CED in CMS approved
prospective comparative studies, where
data may be collected in a registry. In
addition to satisfying the study criteria
specified in the NCD, CMS approved
studies for anti-amyloid mAbs that have
received traditional FDA approval must
address all of the questions below:
• Does the antiamyloid mAb
meaningfully improve health outcomes
(i.e., slow the decline of cognition and
function) for patients in broad
community practice?
• Do benefits, and harms such as
brain hemorrhage and edema, associated
with use of the antiamyloid mAb,
depend on characteristics of patients,
treating clinicians, and settings?
• How do the benefits and harms
change over time?
In order to remove the data collection
requirement under this coverage with
evidence development (CED) NCD or
make any other changes to the existing
policy, we must formally reopen and
reconsider the policy. CMS supported
development of a registry, the
‘‘Monoclonal Antibodies Directed
Against Amyloid for the Treatment of
Alzheimer’s Disease CED Study
Registry’’ (mAb Registry), to facilitate
coverage under the NCD. Additionally,
CMS is working with multiple
organizations preparing to open their
own registries. Once more registries are
available, they will also be listed at
https://www.cms.gov/medicare/
coverage-evidence-development/
monoclonalantibodies-directed-againstamyloid-treatment-alzheimers-diseasead, and clinicians will be able to choose
which registry to participate in.
The data collected and analyzed in
the CMS-supported mAb Registry and
potential CMS-approved registries will
be used by to determine if monoclonal
antibodies directed against amyloid for
the treatment of Alzheimer’s Disease
(AD) is reasonable and necessary (e.g.,
improves health outcomes) for Medicare
beneficiaries under section
1862(a)(1)(A) of the Act. CMS is
collecting information to learn more
about which individuals benefit the
most from this drug. CMS refers to this
as coverage with evidence development
PO 00000
Frm 00038
Fmt 4703
Sfmt 4703
or CED. The information being collected
via registry will be analyzed to assist
clinicians and patients make informed
treatment decisions. Furthermore, data
from the mAb Registry will assist the
pharmaceutical industry and the Food
and Drug Administration (FDA) in
surveillance of the quality, safety and
efficacy of these types of drugs. Form
Number: CMS–10865 (OMB control
number: 0938–NEW); Frequency:
Annually; Affected Public: Business or
other for-profits and Not-for-profit
institutions; Number of Respondents:
40,000; Number of Responses: 40,000;
Total Annual Hours: 3,320. (For policy
questions regarding this collection,
contact Lori Ashby at 410–786–6322.)
Dated: November 15, 2023.
William N. Parham, III,
Director, Paperwork Reduction Staff, Office
of Strategic Operations and Regulatory
Affairs.
[FR Doc. 2023–25601 Filed 11–17–23; 8:45 am]
BILLING CODE 4120–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Medicare & Medicaid
Services
[Document Identifier: CMS–10398 #37]
Medicaid and Children’s Health
Insurance Program (CHIP) Generic
Information Collection Activities:
Proposed Collection; Comment
Request
Centers for Medicare &
Medicaid Services, Health and Human
Services (HHS).
ACTION: Notice.
AGENCY:
On May 28, 2010, the Office
of Management and Budget (OMB)
issued Paperwork Reduction Act (PRA)
guidance related to the ‘‘generic’’
clearance process. Generally, this is an
expedited process by which agencies
may obtain OMB’s approval of
collection of information requests that
are ‘‘usually voluntary, low-burden, and
uncontroversial collections,’’ do not
raise any substantive or policy issues,
and do not require policy or
methodological review. The process
requires the submission of an
overarching plan that defines the scope
of the individual collections that would
fall under its umbrella. On October 23,
2011, OMB approved our initial request
to use the generic clearance process
under control number 0938–1148
(CMS–10398). It was last approved on
April 26, 2021, via the standard PRA
process which included the publication
of 60- and 30-day Federal Register
SUMMARY:
E:\FR\FM\20NON1.SGM
20NON1
]]>Agencies
[Federal Register Volume 88, Number 222 (Monday, November 20, 2023)]
[Notices]
[Pages 80723-80724]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-25601]
=======================================================================
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
[Document Identifier: CMS-10390 and CMS-10865]
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.
DATES: Comments on the collection(s) of information must be received by
the OMB desk officer by December 20, 2023.
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, please access
the CMS PRA website by copying and pasting the following web address
into your web browser: https://www.cms.gov/Regulations-and-Guidance/Legislation/PaperworkReductionActof1995/PRA-Listing.
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: Extension of a currently
approved collection; Title of Information Collection: Hospice Quality
Reporting Program; Use: On July 1, 2014, hospices began using a newly
created data collection instrument,
[[Page 80724]]
titled the ``Hospice Item Set'' (HIS) V1.00.0. The HIS is used for the
collection of quality measure data related to the Hospice Quality
Reporting Program (HQRP), and the HIS V1.00.0 specified the collection
of data items that supported seven Consensus Based Entity (CBE)
endorsed Quality Measures (QMs) for hospice. On April 1, 2017, hospices
began using an updated HIS V2.00.0, which includes the same items from
the HIS V1.00.0 along with the addition of several new items for use in
new measures, measure refinement, patient record matching, and future
public reporting. Data collected from the HIS are used to calculate the
seven CBE-endorsed QMs and the CBE-endorsed Hospice and Palliative Care
Composite Process Measure--Comprehensive Assessment at Admission QM.
During the FY 2021 rule, the Hospice Visits when Death is Imminent
measure pair was removed and replaced with the claims-based Hospice
Visits in Last Days of Life (HVLDL) measure. The reduction in provider
burden and costs occurred when CMS replaced the HIS-based HVWDII
quality measure via the HIS information collection request that OMB
approved on February 16, 2021. CMS is requesting to extend the
expiration date. The HIS V3.00.0 consists of data elements that are
designed to collect standardized, patient-level data for the following
domains of care: pain, respiratory status, medications, patient
preferences and beliefs and values. The HIS V3.00.0 was developed
specifically for use by hospices and contains data elements that we can
use to collect patient-level data to calculate eight CBE endorsed
quality measures. Form Number: CMS-10390 (OMB control number: 0938-
1153); Frequency: On Occasion; Affected Public: State, Local, or Tribal
Governments, Private Sector (not-for-profit institutions); individuals
or households; Number of Respondents: 5,640; Total Annual Responses:
2,763,850; Total Annual Hours: 1,323,883. (For policy questions
regarding this collection contact Jermama Keys at (410) 786-7778.)
2. Type of Information Collection Request: New collection (Request
for a new OMB control number); Title of Information Collection:
Monoclonal Antibodies Directed Against Amyloid for the Treatment of
Alzheimer's Disease; Use: On April 7, 2022, CMS finalized the national
coverage determination (NCD) to cover FDA approved monoclonal
antibodies (mAbs) directed against amyloid for the treatment of
Alzheimer's disease (AD) under coverage with evidence development (CED)
in patients who have a clinical diagnosis of mild cognitive impairment
(MCI) due to AD or mild AD dementia, both with confirmed presence of
amyloid beta pathology consistent with AD. For anti-amyloid mAbs that
have accelerated approval, the mAb may be covered in a randomized
controlled trial conducted under an investigational new drug (IND)
application or any NIH sponsored trial. For antiamyloid mAbs that have
traditional FDA approval (as opposed to accelerated approval), the NCD
specifies coverage under CED in CMS approved prospective comparative
studies, where data may be collected in a registry. In addition to
satisfying the study criteria specified in the NCD, CMS approved
studies for anti-amyloid mAbs that have received traditional FDA
approval must address all of the questions below:
Does the antiamyloid mAb meaningfully improve health
outcomes (i.e., slow the decline of cognition and function) for
patients in broad community practice?
Do benefits, and harms such as brain hemorrhage and edema,
associated with use of the antiamyloid mAb, depend on characteristics
of patients, treating clinicians, and settings?
How do the benefits and harms change over time?
In order to remove the data collection requirement under this
coverage with evidence development (CED) NCD or make any other changes
to the existing policy, we must formally reopen and reconsider the
policy. CMS supported development of a registry, the ``Monoclonal
Antibodies Directed Against Amyloid for the Treatment of Alzheimer's
Disease CED Study Registry'' (mAb Registry), to facilitate coverage
under the NCD. Additionally, CMS is working with multiple organizations
preparing to open their own registries. Once more registries are
available, they will also be listed at https://www.cms.gov/medicare/coverage-evidence-development/monoclonalantibodies-directed-against-amyloid-treatment-alzheimers-disease-ad, and clinicians will be able to
choose which registry to participate in.
The data collected and analyzed in the CMS-supported mAb Registry
and potential CMS-approved registries will be used by to determine if
monoclonal antibodies directed against amyloid for the treatment of
Alzheimer's Disease (AD) is reasonable and necessary (e.g., improves
health outcomes) for Medicare beneficiaries under section 1862(a)(1)(A)
of the Act. CMS is collecting information to learn more about which
individuals benefit the most from this drug. CMS refers to this as
coverage with evidence development or CED. The information being
collected via registry will be analyzed to assist clinicians and
patients make informed treatment decisions. Furthermore, data from the
mAb Registry will assist the pharmaceutical industry and the Food and
Drug Administration (FDA) in surveillance of the quality, safety and
efficacy of these types of drugs. Form Number: CMS-10865 (OMB control
number: 0938-NEW); Frequency: Annually; Affected Public: Business or
other for-profits and Not-for-profit institutions; Number of
Respondents: 40,000; Number of Responses: 40,000; Total Annual Hours:
3,320. (For policy questions regarding this collection, contact Lori
Ashby at 410-786-6322.)
Dated: November 15, 2023.
William N. Parham, III,
Director, Paperwork Reduction Staff, Office of Strategic Operations and
Regulatory Affairs.
[FR Doc. 2023-25601 Filed 11-17-23; 8:45 am]
BILLING CODE 4120-01-P
