Notice of Approval of Product Under Voucher: Rare Pediatric Disease Priority Review Voucher, 4307 [2024-01164]
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Federal Register / Vol. 89, No. 15 / Tuesday, January 23, 2024 / Notices
Number of
respondents
Study
Number of
responses per
respondent
Average
burden hours
per response
Burden hours
Refugee Cash and Medical Assistance Federal Financial Report (ORR–2)
Supplemental Data Collection ......................................................................
Refugee Support Services Federal Financial Report (SF–425) Supplemental
Data Collection .............................................................................................
66
1
1.67
110
53
4
4
848
Totals ........................................................................................................
768
Avg: 2.7
Avg: 8.9
20,555
Burden Estimates—New Requests
Based on use of this generic, we have
revised burden estimates for the next 3
years.
Instrument
Number of
respondents
Number of
responses per
respondent
Average
burden hours
per response
Burden hours
Mandatory Grant Financial Reports .................................................................
1,200
3
9
32,400
Comments: The Department
specifically requests comments on (a)
whether the proposed collection of
information is necessary for the proper
performance of the functions of the
agency, including whether the
information shall have practical utility;
(b) the accuracy of the agency’s estimate
of the burden of the proposed collection
of information; (c) the quality, utility,
and clarity of the information to be
collected; and (d) ways to minimize the
burden of the collection of information
on respondents, including through the
use of automated collection techniques
or other forms of information
technology. Consideration will be given
to comments and suggestions submitted
within 60 days of this publication.
Mary B. Jones,
ACF/OPRE Certifying Officer.
[FR Doc. 2024–01206 Filed 1–22–24; 8:45 am]
BILLING CODE 4184–88–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
khammond on DSKJM1Z7X2PROD with NOTICES
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
SUMMARY:
VerDate Sep<11>2014
17:41 Jan 22, 2024
Jkt 262001
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 (Supplement35) for COSENTYX (secukinumab),
approved June 16, 2020, 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
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 (Supplement35) for COSENTYX (secukinumab)
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 COSENTYX
(secukinumab), go to the ‘‘Drugs@FDA’’
website at https://www.accessdata.fda.
gov/scripts/cder/daf/.
PO 00000
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Dated: January 17, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024–01164 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–D–5430]
Characterization of Metallic Coatings
and/or Calcium Phosphate Coatings on
Orthopedic Devices; Draft Guidance
for Industry and Food and Drug
Administration Staff; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice of availability.
The Food and Drug
Administration (FDA or Agency) is
announcing the availability of the draft
guidance entitled ‘‘Characterization of
Metallic Coatings and/or Calcium
Phosphate Coatings on Orthopedic
Devices.’’ This draft guidance document
provides recommendations for
premarket submissions for orthopedic
devices that contain metallic coatings
and/or calcium phosphate coatings on
the surface. This draft guidance is not
final nor is it for implementation at this
time.
DATES: Submit either electronic or
written comments on the draft guidance
by March 25, 2024 to ensure that the
Agency considers your comment on this
draft guidance before it begins work on
the final version of the guidance.
ADDRESSES: You may submit comments
on any guidance at any time as follows:
SUMMARY:
E:\FR\FM\23JAN1.SGM
23JAN1
]]>Agencies
[Federal Register Volume 89, Number 15 (Tuesday, January 23, 2024)]
[Notices]
[Page 4307]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-01164]
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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-35) for COSENTYX (secukinumab), approved June 16, 2020,
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-35) for
COSENTYX (secukinumab) 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 COSENTYX (secukinumab), 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. 2024-01164 Filed 1-22-24; 8:45 am]
BILLING CODE 4164-01-P
