Notice of Approval of Product Under Voucher: Rare Pediatric Disease Priority Review Voucher; KISQALI (ribociclib), 83017 [2024-23651]
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Federal Register / Vol. 89, No. 199 / Tuesday, October 15, 2024 / Notices
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[FR Doc. 2024–23737 Filed 10–11–24; 8:45 am]
BILLING CODE 4120–01–P
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83017
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Dated: October 8, 2024.
Eric Flamm,
Acting Associate Commissioner for Policy.
Food and Drug Administration
[FR Doc. 2024–23651 Filed 10–11–24; 8:45 am]
BILLING CODE 4164–01–P
[Docket No. FDA–2018–N–1262]
Notice of Approval of Product Under
Voucher: Rare Pediatric Disease
Priority Review Voucher; KISQALI
(ribociclib)
AGENCY:
Food and Drug Administration,
HHS.
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
supplemental application for KISQALI
(ribociclib), approved September 17,
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, email: Cathryn.Lee@
fda.hhs.gov.
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
supplemental application (Supplement18) for KISQALI (ribociclib) 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 KISQALI
(ribociclib), go to the ‘‘Drugs@FDA’’
website at https://www.accessdata.
fda.gov/scripts/cder/daf/.
SUPPLEMENTARY INFORMATION:
PO 00000
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DEPARTMENT OF HEALTH AND
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Food and Drug Administration
[Docket No. FDA–2023–D–4095]
Using Relative Supersaturation To
Support ‘Urinary Tract Health’ Claims
for Adult Maintenance Cat Food;
Guidance for Industry; Availability
AGENCY:
Food and Drug Administration,
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ACTION:
Notice of availability.
The Food and Drug
Administration (FDA, Agency, or we) is
announcing the availability of a final
guidance for industry #284 entitled
‘‘Using Relative Supersaturation To
Support ‘Urinary Tract Health’ Claims
for Adult Maintenance Cat Food.’’
FDA’s Center for Veterinary Medicine
(CVM) has evaluated the use of relative
supersaturation (RSS) methodology to
support urinary tract health claims for
certain adult maintenance cat food. RSS
is a measurement that estimates the
potential for crystal formation and
bladder stone growth, which is a
common affliction in cats. This
guidance provides recommendations for
how pet food manufacturers can use
RSS methodology to substantiate
general structure or function claims that
an adult maintenance cat food supports
urinary tract health by promoting a
healthy mineral content in the urinary
tract.
DATES: The announcement of the
guidance is published in the Federal
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ADDRESSES: You may submit either
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Agency guidances at any time as
follows:
SUMMARY:
Electronic Submissions
Submit electronic comments in the
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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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comment does not include any
confidential information that you or a
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E:\FR\FM\15OCN1.SGM
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]]>Agencies
[Federal Register Volume 89, Number 199 (Tuesday, October 15, 2024)]
[Notices]
[Page 83017]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-23651]
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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; KISQALI (ribociclib)
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: 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 supplemental application for
KISQALI (ribociclib), approved September 17, 2024, meets the criteria
for redeeming 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 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 supplemental application (Supplement-18) for
KISQALI (ribociclib) 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/DevelopingProductsforRareDiseasesConditions/RarePediatricDiseasePriorityVoucherProgram/default.htm. For further
information about KISQALI (ribociclib), go to the ``Drugs@FDA'' website
at https://www.accessdata.fda.gov/scripts/cder/daf/.
Dated: October 8, 2024.
Eric Flamm,
Acting Associate Commissioner for Policy.
[FR Doc. 2024-23651 Filed 10-11-24; 8:45 am]
BILLING CODE 4164-01-P
