Issuance of Priority Review Voucher; Rare Pediatric Disease Product, 84337 [2023-26652]
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Federal Register / Vol. 88, No. 232 / Tuesday, December 5, 2023 / Notices
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Xavier Becerra,
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Services.
[FR Doc. 2023–26512 Filed 12–4–23; 8:45 am]
BILLING CODE 4164–01–P
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.
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), FDA will
award priority review vouchers to
sponsors of approved rare pediatric
disease product applications that meet
certain criteria. FDA has determined
that XENPOZYME (olipudase alfa-rpcp),
manufactured by Genzyme Corporation,
meets the criteria for a priority review
voucher. XENPOZYME (olipudase alfarpcp) is indicated for treatment of noncentral nervous system manifestations
of acid sphingomyelinase deficiency
(ASMD) in adult and pediatric patients.
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/RarePediatricDisease
PriorityVoucherProgram/default.htm.
For further information about
XENPOZYME (olipudase alfa-rpcp), go
to the ‘‘Drugs@FDA’’ website at https://
www.accessdata.fda.gov/scripts/cder/
daf/.
Dated: November 30, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
[FR Doc. 2023–26652 Filed 12–4–23; 8:45 am]
Food and Drug Administration
BILLING CODE 4164–01–P
[Docket No. FDA–2020–N–0026]
Issuance of Priority Review Voucher;
Rare Pediatric Disease Product
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
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 (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 award
of priority review voucher. FDA has
determined that XENPOZYME
(olipudase alfa-rpcp), manufactured by
Genzyme Corporation, meets the criteria
for a priority review voucher.
khammond on DSKJM1Z7X2PROD with NOTICES
SUMMARY:
16:35 Dec 04, 2023
Food and Drug Administration
[Docket No. FDA–2017–N–5569]
Notice.
VerDate Sep<11>2014
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Jkt 262001
Agency Information Collection
Activities; Submission for Office of
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Comment Request; Medical Devices;
Device Tracking
AGENCY:
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Notice.
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SUMMARY:
PO 00000
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84337
Submit written comments
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Find this particular information
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FOR FURTHER INFORMATION CONTACT:
JonnaLynn Capezzuto, Office of
Operations, Food and Drug
Administration, Three White Flint
North, 10 a.m.–12 p.m., 11601
Landsdown St., North Bethesda, MD
20852, 301–796–3794, PRAStaff@
fda.hhs.gov.
In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
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SUPPLEMENTARY INFORMATION:
Medical Devices; Device Tracking—21
CFR Part 821
OMB Control Number 0910–0442—
Extension
Section 519(e)(1) of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C.
360i(e)(1)) provides that FDA may
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III medical device, if the device meets
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the failure of the device would be
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[Federal Register Volume 88, Number 232 (Tuesday, December 5, 2023)]
[Notices]
[Page 84337]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-26652]
-----------------------------------------------------------------------
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 (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 award of priority review voucher. FDA has determined that
XENPOZYME (olipudase alfa-rpcp), manufactured by Genzyme Corporation,
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.
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), FDA will award priority review vouchers to sponsors of approved
rare pediatric disease product applications that meet certain criteria.
FDA has determined that XENPOZYME (olipudase alfa-rpcp), manufactured
by Genzyme Corporation, meets the criteria for a priority review
voucher. XENPOZYME (olipudase alfa-rpcp) is indicated for treatment of
non-central nervous system manifestations of acid sphingomyelinase
deficiency (ASMD) in adult and pediatric patients.
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 XENPOZYME (olipudase alfa-rpcp), go to the
``Drugs@FDA'' website at https://www.accessdata.fda.gov/scripts/cder/daf/.
Dated: November 30, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-26652 Filed 12-4-23; 8:45 am]
BILLING CODE 4164-01-P
