Issuance of Priority Review Voucher; Rare Pediatric Disease Product, 24806-24807 [2023-08518]
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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
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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,
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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]
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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:
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Federal Register / Vol. 88, No. 78 / Monday, April 24, 2023 / Notices
Administration Safety and Innovation
Act (FDASIA), 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
award of the priority review voucher.
FDA has determined that JOENJA
(leniolisib), approved March 24, 2023,
and manufactured by Pharming
Technologies B.V., meets the criteria for
a priority review voucher.
Cathryn Lee, Center for Drug Evaluation
and Research, Food and Drug
Administration, 10903 New Hampshire
Ave., Silver Spring, MD 20993–0002,
301–796–1394, email: Cathryn.Lee@
fda.hhs.gov.
FDA is
announcing the issuance of a priority
review voucher to the sponsor of an
approved rare pediatric disease product
application. Under section 529 of the
FD&C Act (21 U.S.C. 360ff), which was
added by FDASIA, FDA will award
priority review vouchers to sponsors of
approved rare pediatric disease product
applications that meet certain criteria.
FDA has determined that JOENJA
(leniolisib), manufactured by Pharming
Technologies B.V., meets the criteria for
a priority review voucher.
JOENJA (leniolisib) is a kinase
inhibitor indicated for the treatment of
activated phosphoinositide 3-kinase
delta (PI3Kd) syndrome (APDS) in adult
and pediatric patients 12 years of age or
older.
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 JOENJA
(leniolisib), go to the ‘‘Drugs@FDA’’
website at https://
www.accessdata.fda.gov/scripts/cder/
daf/.
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Dated: April 18, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023–08518 Filed 4–21–23; 8:45 am]
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Food and Drug Administration
[Docket No. FDA–2023–N–1259]
Advancing the Utilization and
Supporting the Implementation of
Innovative Manufacturing Approaches;
Public Workshop; Request for
Comments
AGENCY:
Food and Drug Administration,
HHS.
FOR FURTHER INFORMATION CONTACT:
SUPPLEMENTARY INFORMATION:
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Notice of public workshop;
request for comments.
ACTION:
The Food and Drug
Administration (FDA, the Agency, or
we), in cosponsorship with the DukeMargolis Center for Health Policy, is
announcing a public workshop entitled
‘‘Advancing the Utilization and
Supporting the Implementation of
Innovative Manufacturing Approaches.’’
This workshop will address innovative
manufacturing technologies for drug
and biological products and will
include a discussion of potential best
practices, case studies from previous
submissions, potential barriers to
adoption, corresponding regulatory
strategies, and the Advanced
Manufacturing Technologies
Designation Program.
DATES: The public workshop will be
held on June 8, 2023, from 9 a.m. to 4:30
p.m. Eastern Time. Either electronic or
written comments on this public
workshop must be submitted by July 8,
2023. See the SUPPLEMENTARY
INFORMATION section for registration date
and information.
ADDRESSES: The public workshop will
be held at the National Press Club, 529
14th Street NW, Washington, DC 20045.
You may submit comments as
follows. Please note that late, untimely
filed comments will not be considered.
The https://www.regulations.gov
electronic filing system will accept
comments until 11:59 p.m. Eastern Time
on July 8, 2023. Comments received by
mail/hand delivery/courier (for written/
paper submissions) will be considered
timely if they are received on or before
that date.
SUMMARY:
Electronic Submissions
Submit electronic comments in the
following way:
• Federal eRulemaking Portal:
https://www.regulations.gov. Follow the
instructions for submitting comments.
Comments submitted electronically,
including attachments, to https://
www.regulations.gov will be posted to
the docket unchanged. Because your
comment will be made public, you are
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24807
solely responsible for ensuring that your
comment does not include any
confidential information that you or a
third party may not wish to be posted,
such as medical information, your or
anyone else’s Social Security number, or
confidential business information, such
as a manufacturing process. Please note
that if you include your name, contact
information, or other information that
identifies you in the body of your
comments, that information will be
posted on https://www.regulations.gov.
• If you want to submit a comment
with confidential information that you
do not wish to be made available to the
public, submit the comment as a
written/paper submission and in the
manner detailed (see ‘‘Written/Paper
Submissions’’ and ‘‘Instructions’’).
Written/Paper Submissions
Submit written/paper submissions as
follows:
• Mail/Hand Delivery/Courier (for
written/paper submissions): Dockets
Management Staff (HFA–305), Food and
Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments
submitted to the Dockets Management
Staff, FDA will post your comment, as
well as any attachments, except for
information submitted, marked and
identified, as confidential, if submitted
as detailed in ‘‘Instructions.’’
Instructions: All submissions received
must include the Docket No. FDA–
2023–N–1259 for ‘‘Advancing the
Utilization and Supporting the
Implementation of Innovative
Manufacturing Approaches.’’ Received
comments, those filed in a timely
manner (see ADDRESSES), will be placed
in the docket and, except for those
submitted as ‘‘Confidential
Submissions,’’ publicly viewable at
https://www.regulations.gov or at the
Dockets Management Staff between 9
a.m. and 4 p.m., Monday through
Friday, 240–402–7500.
• Confidential Submissions—To
submit a comment with confidential
information that you do not wish to be
made publicly available, submit your
comments only as a written/paper
submission. You should submit two
copies total. One copy will include the
information you claim to be confidential
with a heading or cover note that states
‘‘THIS DOCUMENT CONTAINS
CONFIDENTIAL INFORMATION.’’ The
Agency will review this copy, including
the claimed confidential information, in
its consideration of comments. The
second copy, which will have the
claimed confidential information
redacted/blacked out, will be available
for public viewing and posted on
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]]>Agencies
[Federal Register Volume 88, Number 78 (Monday, April 24, 2023)]
[Notices]
[Pages 24806-24807]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-08518]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
SUMMARY: 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
[[Page 24807]]
Administration Safety and Innovation Act (FDASIA), 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 award of the priority review voucher.
FDA has determined that JOENJA (leniolisib), approved March 24, 2023,
and manufactured by Pharming Technologies B.V., meets the criteria for
a priority review voucher.
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, email:
[email protected].
SUPPLEMENTARY INFORMATION: FDA is announcing the issuance of a priority
review voucher to the sponsor of an approved rare pediatric disease
product application. Under section 529 of the FD&C Act (21 U.S.C.
360ff), which was added by FDASIA, FDA will award priority review
vouchers to sponsors of approved rare pediatric disease product
applications that meet certain criteria. FDA has determined that JOENJA
(leniolisib), manufactured by Pharming Technologies B.V., meets the
criteria for a priority review voucher.
JOENJA (leniolisib) is a kinase inhibitor indicated for the
treatment of activated phosphoinositide 3-kinase delta (PI3K[delta])
syndrome (APDS) in adult and pediatric patients 12 years of age or
older.
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/DevelopingProductsforRareDiseasesConditions/RarePediatricDiseasePriorityVoucherProgram/default.htm. For further
information about JOENJA (leniolisib), go to the ``[email protected]'' website
at https://www.accessdata.fda.gov/scripts/cder/daf/.
Dated: April 18, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-08518 Filed 4-21-23; 8:45 am]
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