Notice of Approval of Product Under Voucher: Rare Pediatric Disease Priority Review Voucher, 4309 [2024-01160]
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807, subpart E .........................................................................
814, subparts A through E ......................................................
812 ...........................................................................................
‘‘Requests for Feedback and Meetings for Medical Device
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Dated: January 17, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024–01158 Filed 1–22–24; 8:45 am]
BILLING CODE 4164–01–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
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 (Supplement1) for ZEPOSIA (ozanimod), approved
May 27, 2021, 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: Cathryn.Lee@
fda.hhs.gov.
SUPPLEMENTARY INFORMATION: FDA is
announcing the approval of a product
redeeming a rare pediatric disease
SUMMARY:
khammond on DSKJM1Z7X2PROD with NOTICES
review by the Office of Management and
Budget (OMB) under the Paperwork
Reduction Act of 1995 (PRA) (44 U.S.C.
3501–3521). The collections of
information in the following table have
been approved by OMB:
21 CFR part or guidance
58 .............................................................................................
VerDate Sep<11>2014
17:41 Jan 22, 2024
Jkt 262001
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 (Supplement1) for ZEPOSIA (ozanimod) 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/
DevelopingProductsforRare
DiseasesConditions/RarePediatric
DiseasePriorityVoucherProgram/
default.htm. For further information
about ZEPOSIA (ozanimod), go to the
‘‘Drugs@FDA’’ website at https://
www.accessdata.fda.gov/scripts/cder/
daf/.
Dated: January 17, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024–01160 Filed 1–22–24; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2023–N–5746]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Record Retention
Requirements for the Soy Protein and
Reduced Risk of Coronary Heart
Disease Health Claim
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA, Agency, or we) is
SUMMARY:
PO 00000
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4309
OMB control No.
0910–0120
0910–0231
0910–0078
0910–0756
0910–0485
0910–0119
announcing an opportunity for public
comment on the proposed collection of
certain information by the Agency.
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 of an
existing collection of information, and
to allow 60 days for public comment in
response to the notice. This notice
solicits comments on the record
retention requirements for the soy
protein/coronary heart disease (CHD)
health claim.
DATES: Either electronic or written
comments on the collection of
information must be submitted by
March 25, 2024.
ADDRESSES: 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 at the end of
March 25, 2024. Comments received by
mail/hand delivery/courier (for written/
paper submissions) will be considered
timely if they are received on or before
that date.
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confidential information that you or a
third party may not wish to be posted,
such as medical information, your or
E:\FR\FM\23JAN1.SGM
23JAN1
]]>Agencies
[Federal Register Volume 89, Number 15 (Tuesday, January 23, 2024)]
[Notices]
[Page 4309]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-01160]
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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
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
(Supplement-1) for ZEPOSIA (ozanimod), approved May 27, 2021, 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-1) for ZEPOSIA
(ozanimod) 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 ZEPOSIA (ozanimod), go to the ``Drugs@FDA'' website
at https://www.accessdata.fda.gov/scripts/cder/daf/.
Dated: January 17, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024-01160 Filed 1-22-24; 8:45 am]
BILLING CODE 4164-01-P
