Intent To Award a Single-Source Supplement To Provide the National Aging Network With Timely, Relevant, High-Quality Opportunities To Further Enhance Knowledge, Awareness and Models Related to Falls Prevention, 24805-24806 [2023-08546]
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Federal Register / Vol. 88, No. 78 / Monday, April 24, 2023 / Notices
Jeffrey M. Zirger,
Lead, Information Collection Review Office,
Office of Scientific Integrity, Office of Science,
Centers for Disease Control and Prevention.
[FR Doc. 2023–08571 Filed 4–21–23; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Medicare & Medicaid
Services
[Document Identifiers: CMS–10844]
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.
DATES: Comments on the collection(s) of
information must be received by the
OMB desk officer by May 24, 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
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SUMMARY:
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18:50 Apr 21, 2023
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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 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: New collection (Request for a
new OMB control number); Title of
Information Collection: Small Biotech
Exception; Use: Under the authority in
sections 11001 and 11002 of the
Inflation Reduction Act of 2022 (Pub. L.
117–169), the Centers for Medicare &
Medicaid Services (CMS) is
implementing the Medicare Drug Price
Negotiation Program, codified in
sections 1191 through 1198 of the Social
Security Act (the Act). In accordance
with section 1192(d)(2) of the Act, the
term ‘‘negotiation-eligible drug’’
excludes, with respect to the initial
price applicability years 2026, 2027, and
2028, a qualifying single source drug
that meets the requirements for the
exception for small biotech drugs (the
‘‘Small Biotech Exception’’).
This information is required in order
for CMS to accurately identify whether
a given drug meets the criteria for the
Small Biotech Exception in accordance
with section 1192(d)(2) of the Act. To
ensure that only covered Part D drugs
that meet the requirements for the Small
Biotech Exception are excluded from
the term ‘‘negotiation-eligible drug,’’ a
manufacturer that seeks the Small
Biotech Exception for its covered Part D
drug (‘‘Submitting Manufacturer’’) must
submit information to CMS about the
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24805
company and its products in order for
the drug to be considered for the
exception. If the Submitting
Manufacturer seeks the Small Biotech
Exception for a covered Part D drug it
acquired after December 31, 2021, the
Submitting Manufacturer must also
submit information related to the
separate entity that had the Medicare
Coverage Gap Discount Program
agreement for the drug on December 31,
2021. The Information Collection
Request Form for the Small Biotech
Exception must be submitted to CMS
before CMS establishes the selected
drug list for initial price applicability
year 2026. Form Number: CMS–10844
(OMB control number: 0938-New);
Frequency: Once; Affected Public:
Private sector, Business or other forprofit; Number of Respondents: 10;
Total Annual Responses: 10; Total
Annual Hours: 68.5. (For policy
questions regarding this collection
contact Corey Rosenberg at 410–786–
9763.)
Dated: April 19, 2023.
William N. Parham, III,
Director, Paperwork Reduction Staff, Office
of Strategic Operations and Regulatory
Affairs.
[FR Doc. 2023–08600 Filed 4–21–23; 8:45 am]
BILLING CODE 4120–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Administration for Community Living
Intent To Award a Single-Source
Supplement To Provide the National
Aging Network With Timely, Relevant,
High-Quality Opportunities To Further
Enhance Knowledge, Awareness and
Models Related to Falls Prevention
ACTION:
Notice.
The Administration for
Community Living (ACL) announces the
intent to award a single-source
supplement to the current cooperative
agreement held by the National Council
on Aging (NCOA) for the National Falls
Prevention Resource Center. The
purpose of this program is to advance
the development and expansion of
technical assistance, education, and
resources to increase public awareness
about the risk of falls and how to
prevent them; increase the number of
older adults and adults with disabilities
who participate in evidence-based
community falls prevention programs;
and support the integration and
sustainability of evidence-based falls
prevention programs within community
integrated health networks.
SUMMARY:
E:\FR\FM\24APN1.SGM
24APN1
24806
Federal Register / Vol. 88, No. 78 / Monday, April 24, 2023 / Notices
For
further information or comments
regarding this program supplement,
contact Donna Bethge, U.S. Department
of Health and Human Services,
Administration for Community Living,
Administration on Aging, Office of
Nutrition and Health Promotion
Programs, 202–795–7659,
donna.bethge@acl.hhs.gov.
SUPPLEMENTARY INFORMATION: The
purpose of this supplement is to:
• support the development of a
survey of key stakeholders to determine
falls prevention gaps, opportunities, and
priorities in the aging network and
expand the Falls Summit to capture
strategies and action steps to address
those gaps with nationally recognized
experts in falls prevention,
organizations from the health, nutrition,
and aging sectors, select federal and
state agencies, professional associations,
corporations, and foundations that have
an interest in healthy aging;
• expand upon the reach of the Falls
Prevention Awareness Week to
incorporate additional messaging
regarding healthy aging, independence
and quality of life that can be realized
by moving from falls prevention
awareness to action. This will include
crafting new messages that will be
disseminated to a broader audience to
better resonate with older adults and
their caregivers;
• provide further development of
leaders in the falls prevention network
through a fellowship program to focus
on systems change to reduce falls, falls
risk factors, and fall related injuries to
ultimately improve the lives of older
adults and save health care dollars; and
• cultivate and leverage partnerships
with traditional and new partners, such
as emergency medical services,
paramedicine, transportation, housing,
nutrition, and primary care providers to
develop clinical and community
collaborative best-practice frameworks
and models designed to address
multiple risk factors in innovative and
scalable ways that would include a
strong focus on increasing participation
in evidence-based falls prevention
programs and embedding those
programs into the aging network in
order to support healthy and active
opportunities for older adults. This
supplement would provide the
resources necessary to pilot test these
frameworks and models in
communities.
The administrative supplement for FY
2023 will be in the amount of
$2,000,000, bringing the total award for
FY 2023 to $3,000,000.
The additional funding will not be
used to begin new projects, but it will
ddrumheller on DSK120RN23PROD with NOTICES1
FOR FURTHER INFORMATION CONTACT:
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18:50 Apr 21, 2023
Jkt 259001
be used to enhance existing efforts. The
grantee will continue to provide
appropriate, quality falls prevention
resources, increase public awareness
about falls prevention and the risk of
falls, support the implementation of
evidence-based falls prevention
programs, and seek new opportunities
to embed falls prevention evidencebased programs in the community.
Program Name: National Falls
Prevention Resource Center.
Recipient: National Council on Aging
(NCOA).
Period of Performance: The
supplement award will be issued for the
third year of a five-year project period
of August 1, 2021, to July 31, 2026.
Total Award Amount: $3,000,000 in
FY 2023.
Award Type: Cooperative Agreement
Supplement.
Statutory Authority: The Older
Americans Act, Title IV; and the Patient
Protection and Affordable Care Act, 42
U.S.C. 300u–11 (Prevention and Public
Health Fund).
Basis for Award
National Council on Aging (NCOA) is
currently funded to carry out the
objectives of this project through its
current cooperative agreement entitled,
National Falls Prevention Resource
Center for the period of August 1, 2021,
through July 31, 2026. Since the
project’s implementation, the grantee
has made satisfactory progress toward
its approved work plan. The
supplement will enable the grantee to
carry their work even further, enhancing
the support they provide to the Aging
Network Falls Prevention Providers.
The additional funding will not be used
to begin new projects or activities, but
rather to enhance efforts.
NCOA is uniquely positioned to
complete the work called for under this
project. They have an already
established infrastructure and are a
known and trusted organization in the
Aging Network. Prior to this current
award, NCOA competed and was twice
awarded the National Falls Prevention
Resource Center for the past 7 years.
They have an established presence
within the Aging Network. They have a
comprehensive, interactive web-based
repository (https://ncoa.org/
professionals/health/center-for-healthyaging/national-falls-preventionresource-center) with tools and
resources, including—best practices tip
sheets, program and fidelity guidance,
Falls Prevention Awareness Week
toolkit, educational webinars, Grand
Rounds recordings, articles covering
topics from program implementation
through sustainability, resource hubs,
PO 00000
Frm 00056
Fmt 4703
Sfmt 4703
policy and practice models, the Falls
Free Checkup online screening tool and
they maintain the national falls
prevention database. Under this current
award period, they are providing
technical assistance and educational
opportunities for the Aging Network’s
Falls Prevention efforts, including
workgroups, webinars, and live
trainings. They collaborate nationally
with state falls prevention collaboratives
and host the annual Age + Action
Conference, a grantee gathering to
explore solutions to ensure equitable
aging for all, connecting with
colleagues, sharing innovative ideas,
and discussing policy solutions that can
be achieved together on behalf of older
adults. They have reached thousands of
providers using their comprehensive
database of SUAs, AAAs, and other
Falls Prevention Program stakeholders.
In addition, they have developed
partnerships with organizations,
universities, and other entities to
provide technical assistance, education,
and support for the Aging Network.
Establishing an entirely new grant
project at this time would be potentially
disruptive to the current work already
well under way. More importantly, it
could cause confusion among the Aging
Network Falls Prevention Program
Providers and stakeholders, which
could have a negative effect on training,
implementation, and support
opportunities. If this supplement were
not provided, the project would be
unable to address the significant unmet
needs of the Aging Network Falls
Prevention Program.
Dated: April 18, 2023.
Alison Barkoff,
Acting Administrator and Assistant Secretary
for Aging.
[FR Doc. 2023–08546 Filed 4–21–23; 8:45 am]
BILLING CODE 4154–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2020–N–0026]
Issuance of Priority Review Voucher;
Rare Pediatric Disease Product
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing the
issuance of a priority review voucher to
the sponsor of a rare pediatric disease
product application. The Federal Food,
Drug, and Cosmetic Act (the FD&C Act),
as amended by the Food and Drug
SUMMARY:
E:\FR\FM\24APN1.SGM
24APN1
]]>Agencies
[Federal Register Volume 88, Number 78 (Monday, April 24, 2023)]
[Notices]
[Pages 24805-24806]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-08546]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Administration for Community Living
Intent To Award a Single-Source Supplement To Provide the
National Aging Network With Timely, Relevant, High-Quality
Opportunities To Further Enhance Knowledge, Awareness and Models
Related to Falls Prevention
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Administration for Community Living (ACL) announces the
intent to award a single-source supplement to the current cooperative
agreement held by the National Council on Aging (NCOA) for the National
Falls Prevention Resource Center. The purpose of this program is to
advance the development and expansion of technical assistance,
education, and resources to increase public awareness about the risk of
falls and how to prevent them; increase the number of older adults and
adults with disabilities who participate in evidence-based community
falls prevention programs; and support the integration and
sustainability of evidence-based falls prevention programs within
community integrated health networks.
[[Page 24806]]
FOR FURTHER INFORMATION CONTACT: For further information or comments
regarding this program supplement, contact Donna Bethge, U.S.
Department of Health and Human Services, Administration for Community
Living, Administration on Aging, Office of Nutrition and Health
Promotion Programs, 202-795-7659, [email protected].
SUPPLEMENTARY INFORMATION: The purpose of this supplement is to:
support the development of a survey of key stakeholders to
determine falls prevention gaps, opportunities, and priorities in the
aging network and expand the Falls Summit to capture strategies and
action steps to address those gaps with nationally recognized experts
in falls prevention, organizations from the health, nutrition, and
aging sectors, select federal and state agencies, professional
associations, corporations, and foundations that have an interest in
healthy aging;
expand upon the reach of the Falls Prevention Awareness
Week to incorporate additional messaging regarding healthy aging,
independence and quality of life that can be realized by moving from
falls prevention awareness to action. This will include crafting new
messages that will be disseminated to a broader audience to better
resonate with older adults and their caregivers;
provide further development of leaders in the falls
prevention network through a fellowship program to focus on systems
change to reduce falls, falls risk factors, and fall related injuries
to ultimately improve the lives of older adults and save health care
dollars; and
cultivate and leverage partnerships with traditional and
new partners, such as emergency medical services, paramedicine,
transportation, housing, nutrition, and primary care providers to
develop clinical and community collaborative best-practice frameworks
and models designed to address multiple risk factors in innovative and
scalable ways that would include a strong focus on increasing
participation in evidence-based falls prevention programs and embedding
those programs into the aging network in order to support healthy and
active opportunities for older adults. This supplement would provide
the resources necessary to pilot test these frameworks and models in
communities.
The administrative supplement for FY 2023 will be in the amount of
$2,000,000, bringing the total award for FY 2023 to $3,000,000.
The additional funding will not be used to begin new projects, but
it will be used to enhance existing efforts. The grantee will continue
to provide appropriate, quality falls prevention resources, increase
public awareness about falls prevention and the risk of falls, support
the implementation of evidence-based falls prevention programs, and
seek new opportunities to embed falls prevention evidence-based
programs in the community.
Program Name: National Falls Prevention Resource Center.
Recipient: National Council on Aging (NCOA).
Period of Performance: The supplement award will be issued for the
third year of a five-year project period of August 1, 2021, to July 31,
2026.
Total Award Amount: $3,000,000 in FY 2023.
Award Type: Cooperative Agreement Supplement.
Statutory Authority: The Older Americans Act, Title IV; and the
Patient Protection and Affordable Care Act, 42 U.S.C. 300u-11
(Prevention and Public Health Fund).
Basis for Award
National Council on Aging (NCOA) is currently funded to carry out
the objectives of this project through its current cooperative
agreement entitled, National Falls Prevention Resource Center for the
period of August 1, 2021, through July 31, 2026. Since the project's
implementation, the grantee has made satisfactory progress toward its
approved work plan. The supplement will enable the grantee to carry
their work even further, enhancing the support they provide to the
Aging Network Falls Prevention Providers. The additional funding will
not be used to begin new projects or activities, but rather to enhance
efforts.
NCOA is uniquely positioned to complete the work called for under
this project. They have an already established infrastructure and are a
known and trusted organization in the Aging Network. Prior to this
current award, NCOA competed and was twice awarded the National Falls
Prevention Resource Center for the past 7 years. They have an
established presence within the Aging Network. They have a
comprehensive, interactive web-based repository (https://ncoa.org/professionals/health/center-for-healthy-aging/national-falls-prevention-resource-center) with tools and resources, including--best
practices tip sheets, program and fidelity guidance, Falls Prevention
Awareness Week toolkit, educational webinars, Grand Rounds recordings,
articles covering topics from program implementation through
sustainability, resource hubs, policy and practice models, the Falls
Free Checkup online screening tool and they maintain the national falls
prevention database. Under this current award period, they are
providing technical assistance and educational opportunities for the
Aging Network's Falls Prevention efforts, including workgroups,
webinars, and live trainings. They collaborate nationally with state
falls prevention collaboratives and host the annual Age + Action
Conference, a grantee gathering to explore solutions to ensure
equitable aging for all, connecting with colleagues, sharing innovative
ideas, and discussing policy solutions that can be achieved together on
behalf of older adults. They have reached thousands of providers using
their comprehensive database of SUAs, AAAs, and other Falls Prevention
Program stakeholders. In addition, they have developed partnerships
with organizations, universities, and other entities to provide
technical assistance, education, and support for the Aging Network.
Establishing an entirely new grant project at this time would be
potentially disruptive to the current work already well under way. More
importantly, it could cause confusion among the Aging Network Falls
Prevention Program Providers and stakeholders, which could have a
negative effect on training, implementation, and support opportunities.
If this supplement were not provided, the project would be unable to
address the significant unmet needs of the Aging Network Falls
Prevention Program.
Dated: April 18, 2023.
Alison Barkoff,
Acting Administrator and Assistant Secretary for Aging.
[FR Doc. 2023-08546 Filed 4-21-23; 8:45 am]
BILLING CODE 4154-01-P
