Agency Information Collection Activities: Proposed Collection; Comment Request, 2005-2006 [2025-00399]
Download as PDF
Federal Register / Vol. 90, No. 6 / Friday, January 10, 2025 / Notices
review by the Office of Management and
Budget under the authority of the
Paperwork Reduction Act of 1995 (44
U.S.C. Chapter 35).
The Administrator of the Centers for
Medicare & Medicaid Services (CMS),
Chiquita Brooks-LaSure, having
reviewed and approved this document,
authorizes Chyana Woodyard, who is
the Federal Register Liaison, to
electronically sign this document for
purposes of publication in the Federal
Register.
Chyana Woodyard,
Federal Register Liaison, Centers for Medicare
& Medicaid Services.
[FR Doc. 2025–00385 Filed 1–8–25; 8:45 am]
BILLING CODE 4120–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Medicare & Medicaid
Services
[Document Identifiers: CMS–10069]
Agency Information Collection
Activities: Proposed Collection;
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
60 days for public comment on the
proposed action. Interested persons are
invited to send comments regarding our
burden estimates 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 must be received by
March 11, 2025.
ADDRESSES: When commenting, please
reference the document identifier or
OMB control number. To be assured
khammond on DSK9W7S144PROD with NOTICES
SUMMARY:
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17:28 Jan 08, 2025
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consideration, comments and
recommendations must be submitted in
any one of the following ways:
1. Electronically. You may send your
comments electronically to https://
www.regulations.gov. Follow the
instructions for ‘‘Comment or
Submission’’ or ‘‘More Search Options’’
to find the information collection
document(s) that are accepting
comments.
2. By regular mail. You may mail
written comments to the following
address: CMS, Office of Strategic
Operations and Regulatory Affairs,
Division of Regulations Development,
Attention: Document Identifier/OMB
Control Number: ll, Room C4–26–05,
7500 Security Boulevard, Baltimore,
Maryland 21244–1850.
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
FOR FURTHER INFORMATION CONTACT:
William N. Parham at (410) 786–4669.
SUPPLEMENTARY INFORMATION:
Contents
This notice sets out a summary of the
use and burden associated with the
following information collections. More
detailed information can be found in
each collection’s supporting statement
and associated materials (see
ADDRESSES).
CMS 10069 Rural Community Hospital
Demonstration Program Application
Under the 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
requires Federal agencies to publish a
60-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.
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Frm 00069
Fmt 4703
Sfmt 4703
2005
Information Collections
1. Type of Information Collection
Request: Reinstatement of a previously
approved collection; Title of
Information Collection: Rural
Community Hospital Demonstration
Program Application; Use: CMS is
requesting the information collection
request previously approved under
OMB control number 0938–0880, the
Medicare Waiver Demonstration/Model
Application, be reinstated. The approval
lapsed due to an administrative
oversight.
The Centers for Medicare & Medicaid
Services (CMS) has operated the
statutory Rural Community Hospital
(RCH) Demonstration since 2004. The
authorizing statute instructed CMS to
test cost-based payment for Medicare
inpatient services for rural hospitals
with fewer than 51 beds that are not
eligible to be Critical Access Hospitals
(CAH).
The RCH Demonstration Program was
initially authorized by section 410A of
the Medicare Modernization Act (MMA)
of 2003. Following the initial 5-year
authorization, the demonstration has
been extended 3 times, each time for an
additional 5 years—first, by Sections
3123 and 10313 of the Affordable Care
Act; then by section 15003 of the 21st
Century Cures Act; and by section 128
of the Consolidated Appropriations Act
of 2021. Currently, the demonstration
has 20 participants out of a maximum
of 30 hospitals, and it is scheduled to
end in 2028.
For previous authorizations, CMS has
issued a Request for Applications (RFA)
to solicit applications for the
demonstration program. For the last
solicitation, in 2017, CMS received 51
applications for 13 open spaces. CMS is
planning on a new RFA to fill the ten
spaces that are currently open.
Per the RFA, applications are
requested in identical format, regardless
of the specific goals and projects of the
individual applicants. The standardized
application format is not controversial,
and it will reduce burden on applicants
and reviewers. Responses are strictly
voluntary. The standard format will
enable CMS to select proposals that
meet CMS objectives and show the best
potential for success.
The RFA will ask interested hospitals
to provide a problem statement,
strategies for ongoing financial viability,
goals for participation in the
demonstration, and plans for
collaboration with other providers in
the area. Applications will be submitted
in the user-friendly format outlined in
the Medicare Waiver Demonstration/
Model Application.
E:\FR\FM\10JAN1.SGM
10JAN1
2006
Federal Register / Vol. 90, No. 6 / Friday, January 10, 2025 / Notices
A panel of evaluators will be
assembled and utilize a standardized
rubric to score the submitted proposals
and identify hospitals with the highest
scores. Results will be used to guide the
future of the Medicare and Medicaid
programs and to inform reform
initiatives. Form Number: CMS–10069
(OMB control number: 0938–0880);
Frequency: Once; Affected Public:
Business or other for-profits and Notfor-profit institutions; Number of
Respondents: 30; Total Annual
Responses: 30; Total Annual Hours:
2,400. (For policy questions regarding
this collection contact Alexis Lilly at
410–786–3501).
William N. Parham, III,
Director, Division of Information Collections
and Regulatory Impacts, Office of Strategic
Operations and Regulatory Affairs.
[FR Doc. 2025–00399 Filed 1–8–25; 8:45 am]
BILLING CODE 4120–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Administration for Children and
Families
Amendment of the Statement of
Organizations, Functions and
Delegation of Authority
Office of Refugee Resettlement,
Administration for Children and
Families, Department of Health and
Human Services.
ACTION: Notice of amendment.
AGENCY:
The Administration for
Children and Families (ACF) is
amending the Statement of
Organization, Functions and Delegation
of Authority (‘‘Statement’’) issued in the
Federal Register on April 28, 2009. The
Statement delegated specific provisions
of the William Wilberforce Trafficking
Victims Protection Reauthorization Act
of 2008, Public Law 110–457, section
235 from the Assistant Secretary for
Children and Families to the Director of
the Office of Refugee Resettlement. This
amendment modifies the Statement to
authorize the Director of the Office of
Refugee Resettlement to redelegate the
listed authorities contained within the
Statement.
DATES: This amendment of the April 28,
2009, Statement of Organization,
Functions and Delegation of Authority
is effective on date of signature.
FOR FURTHER INFORMATION CONTACT:
Toby Biswas, Director of Policy,
Division of Unaccompanied Children
Policy, Unaccompanied Children
Bureau, Office of Refugee Resettlement,
khammond on DSK9W7S144PROD with NOTICES
SUMMARY:
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17:28 Jan 08, 2025
Jkt 265001
Administration for Children and
Families, Department of Health and
Human Services, Washington, DC, (202)
205–4440 or UCPolicyRegulatoryAffairs@acf.hhs.gov.
SUPPLEMENTARY INFORMATION:
The first paragraph of the Statement
of Organization, Functions and
Delegation of Authority issued in the
Federal Register on April 28, 2009 (74
FR 19232) currently reads as follows:
‘‘Notice is hereby given that I delegate
to the Director of the Office of Refugee
Resettlement the following authority
delegated to the Assistant Secretary for
Children and Families by the Secretary
of the Department of Health and Human
Services (HHS) under the William
Wilberforce Trafficking Victims
Protection Reauthorization Act of 2008,
Public Law 110–457, section 235.’’
This paragraph is amended to read as
follows:
‘‘Notice is hereby given that I have
delegated to the Director of the Office of
Refugee Resettlement, with authority to
re-delegate, the following authority
delegated to the Assistant Secretary for
Children and Families by the Secretary
of the Department of Health and Human
Services (HHS) under the William
Wilberforce Trafficking Victims
Protection Reauthorization Act of 2008,
Public Law 110–457, section 235.’’
The intention of this amendment is to
provide notice to the public of the
Assistant Secretary’s delegation of
authority provided in subsequent
portions of the notice, as well as the
authority to redelegate the listed
authorities.
All other provisions of the Statement
of Organization, Functions and
Delegation of Authority issued in the
Federal Register on April 28, 2009 (74
FR 19232) will remain unchanged.
Meg Sullivan,
Principal Deputy Assistant Secretary for the
Administration for Children and Families,
performing the delegable duties of the
Assistant Secretary for Children and Families.
[FR Doc. 2025–00262 Filed 1–8–25; 8:45 am]
BILLING CODE 4184–45–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2018–N–1262]
Notice of Approval of Product Under
Voucher: Rare Pediatric Disease
Priority Review Voucher; ALYFTREK
(vanzacaftor, tezacaftor, and
deutivacaftor)
AGENCY:
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing the
issuance of approval of a product
redeeming a priority review voucher.
The Federal Food, Drug, and Cosmetic
Act (FD&C Act) authorizes FDA to
award priority review vouchers to
sponsors of approved rare pediatric
disease product applications that meet
certain criteria. FDA is required to
publish notice of the issuance of priority
review vouchers as well as the approval
of products redeeming a priority review
voucher. FDA has determined that the
application for ALYFTREK (vanzacaftor,
tezacaftor, and deutivacaftor), approved
December 20, 2024, meets the criteria
for redeeming a priority review voucher.
SUMMARY:
FOR FURTHER INFORMATION CONTACT:
Cathryn Lee, Center for Drug Evaluation
and Research, Food and Drug
Administration, 10903 New Hampshire
Ave., Silver Spring, MD 20993–0002,
301–796–1394.
FDA is
announcing the approval of a product
redeeming a rare pediatric disease
priority review voucher. Under section
529 of the FD&C Act (21 U.S.C. 360ff),
FDA will report the issuance of rare
pediatric disease priority review
vouchers and the approval of products
for which a voucher was redeemed.
FDA has determined that the
application for ALYFTREK (vanzacaftor,
tezacaftor, and deutivacaftor) tablets
meets the redemption criteria.
For further information about the Rare
Pediatric Disease Priority Review
Voucher Program and for a link to the
full text of section 529 of the FD&C Act,
go to https://www.fda.gov/ForIndustry/
DevelopingProductsforRareDiseases
Conditions/RarePediatricDiseasePriority
VoucherProgram/default.htm. For
further information about ALYFTREK
(vanzacaftor, tezacaftor, and
deutivacaftor), go to the ‘‘Drugs@FDA’’
website at https://
www.accessdata.fda.gov/scripts/cder/
daf/.
SUPPLEMENTARY INFORMATION:
Dated: January 3, 2025.
P. Ritu Nalubola,
Associate Commissioner for Policy.
[FR Doc. 2025–00341 Filed 1–8–25; 8:45 am]
BILLING CODE 4164–01–P
Food and Drug Administration,
HHS.
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10JAN1
Agencies
[Federal Register Volume 90, Number 6 (Friday, January 10, 2025)]
[Notices]
[Pages 2005-2006]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2025-00399]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
[Document Identifiers: CMS-10069]
Agency Information Collection Activities: Proposed Collection;
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 60 days for public comment on
the proposed action. Interested persons are invited to send comments
regarding our burden estimates 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 must be received by March 11, 2025.
ADDRESSES: When commenting, please reference the document identifier or
OMB control number. To be assured consideration, comments and
recommendations must be submitted in any one of the following ways:
1. Electronically. You may send your comments electronically to
https://www.regulations.gov. Follow the instructions for ``Comment or
Submission'' or ``More Search Options'' to find the information
collection document(s) that are accepting comments.
2. By regular mail. You may mail written comments to the following
address: CMS, Office of Strategic Operations and Regulatory Affairs,
Division of Regulations Development, Attention: Document Identifier/OMB
Control Number: __, Room C4-26-05, 7500 Security Boulevard, Baltimore,
Maryland 21244-1850.
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 N. Parham at (410) 786-4669.
SUPPLEMENTARY INFORMATION:
Contents
This notice sets out a summary of the use and burden associated
with the following information collections. More detailed information
can be found in each collection's supporting statement and associated
materials (see ADDRESSES).
CMS 10069 Rural Community Hospital Demonstration Program Application
Under the 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 requires Federal agencies
to publish a 60-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.
Information Collections
1. Type of Information Collection Request: Reinstatement of a
previously approved collection; Title of Information Collection: Rural
Community Hospital Demonstration Program Application; Use: CMS is
requesting the information collection request previously approved under
OMB control number 0938-0880, the Medicare Waiver Demonstration/Model
Application, be reinstated. The approval lapsed due to an
administrative oversight.
The Centers for Medicare & Medicaid Services (CMS) has operated the
statutory Rural Community Hospital (RCH) Demonstration since 2004. The
authorizing statute instructed CMS to test cost-based payment for
Medicare inpatient services for rural hospitals with fewer than 51 beds
that are not eligible to be Critical Access Hospitals (CAH).
The RCH Demonstration Program was initially authorized by section
410A of the Medicare Modernization Act (MMA) of 2003. Following the
initial 5-year authorization, the demonstration has been extended 3
times, each time for an additional 5 years--first, by Sections 3123 and
10313 of the Affordable Care Act; then by section 15003 of the 21st
Century Cures Act; and by section 128 of the Consolidated
Appropriations Act of 2021. Currently, the demonstration has 20
participants out of a maximum of 30 hospitals, and it is scheduled to
end in 2028.
For previous authorizations, CMS has issued a Request for
Applications (RFA) to solicit applications for the demonstration
program. For the last solicitation, in 2017, CMS received 51
applications for 13 open spaces. CMS is planning on a new RFA to fill
the ten spaces that are currently open.
Per the RFA, applications are requested in identical format,
regardless of the specific goals and projects of the individual
applicants. The standardized application format is not controversial,
and it will reduce burden on applicants and reviewers. Responses are
strictly voluntary. The standard format will enable CMS to select
proposals that meet CMS objectives and show the best potential for
success.
The RFA will ask interested hospitals to provide a problem
statement, strategies for ongoing financial viability, goals for
participation in the demonstration, and plans for collaboration with
other providers in the area. Applications will be submitted in the
user-friendly format outlined in the Medicare Waiver Demonstration/
Model Application.
[[Page 2006]]
A panel of evaluators will be assembled and utilize a standardized
rubric to score the submitted proposals and identify hospitals with the
highest scores. Results will be used to guide the future of the
Medicare and Medicaid programs and to inform reform initiatives. Form
Number: CMS-10069 (OMB control number: 0938-0880); Frequency: Once;
Affected Public: Business or other for-profits and Not-for-profit
institutions; Number of Respondents: 30; Total Annual Responses: 30;
Total Annual Hours: 2,400. (For policy questions regarding this
collection contact Alexis Lilly at 410-786-3501).
William N. Parham, III,
Director, Division of Information Collections and Regulatory Impacts,
Office of Strategic Operations and Regulatory Affairs.
[FR Doc. 2025-00399 Filed 1-8-25; 8:45 am]
BILLING CODE 4120-01-P