Notice of Approval of Product Under Voucher: Rare Pediatric Disease Priority Review Voucher, 72491 [2022-25644]
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72491
Federal Register / Vol. 87, No. 226 / Friday, November 25, 2022 / Notices
Number of
respondents
Respondent/data collection activity
Responses per
respondent
Hours per
response
Annual
burden hours
Data entry staff (Program Information Cover Sheet, Attendance Log, Participant Information Survey).
70
Once per program times 1,360
programs.
.20
272.0
Total Burden Hours ........................................................
........................
..................................................
........................
** 3,534
** Rounded to the nearest hour.
Dated: November 18, 2022.
Alison Barkoff,
Acting Administrator and Assistant Secretary
for Aging.
[FR Doc. 2022–25698 Filed 11–23–22; 8:45 am]
BILLING CODE 4154–01–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), as amended by the
Food and Drug 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
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 SKYRIZI
(risankizumab-rzaa), approved June 16,
2022, 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),
which was added by FDASIA, FDA will
report the issuance of rare pediatric
disease priority review vouchers and the
approval of products for which a
khammond on DSKJM1Z7X2PROD with NOTICES
SUMMARY:
VerDate Sep<11>2014
18:43 Nov 23, 2022
Jkt 259001
voucher was redeemed. FDA has
determined that the supplemental
application for SKYRIZI (risankizumabrzaa), approved June 16, 2022, 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 SKYRIZI
(risankizumab-rzaa), approved June 16,
2022, go to the ‘‘Drugs@FDA’’ website at
https://www.accessdata.fda.gov/scripts/
cder/daf/.
Dated: November 18, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022–25644 Filed 11–23–22; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2022–N–2782]
Antimicrobial Drugs Advisory
Committee; Notice of Meeting;
Establishment of a Public Docket;
Request for Comments
Food and Drug Administration,
Department of Health and Human
Services (HHS).
ACTION: Notice; establishment of a
public docket; request for comments.
AGENCY:
The Food and Drug
Administration (FDA) announces a
forthcoming public advisory committee
meeting of the Antimicrobial Drugs
Advisory Committee. The general
function of the committee is to provide
advice and recommendations to FDA on
regulatory issues. The meeting will be
open to the public. FDA is establishing
a docket for public comment on this
document.
SUMMARY:
The meeting will be held
virtually on January 24, 2023, from 9
a.m. to 4:30 p.m. Eastern Time.
ADDRESSES: Please note that due to the
impact of the COVID–19 pandemic, all
DATES:
PO 00000
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meeting participants will be joining this
advisory committee meeting via an
online teleconferencing platform.
Answers to commonly asked questions
about FDA advisory committee meetings
may be accessed at: https://
www.fda.gov/AdvisoryCommittees/
AboutAdvisoryCommittees/
ucm408555.htm.
FDA is establishing a docket for
public comment on this meeting. The
docket number is FDA–2022–N–2782.
Please note that late, untimely filed
comments will not be considered. The
docket will close on January 23, 2023.
The https://www.regulations.gov
electronic filing system will accept
comments until 11:59 p.m. Eastern Time
at the end of January 23, 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.
Comments received on or before
January 9, 2023, will be provided to the
committee. Comments received after
that date will be taken into
consideration by FDA. In the event that
the meeting is cancelled, FDA will
continue to evaluate any relevant
applications or information, and
consider any comments submitted to the
docket, as appropriate.
You may submit comments as
follows:
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
solely responsible for ensuring that your
comment does not include any
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such as medical information, your or
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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
E:\FR\FM\25NON1.SGM
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]]>Agencies
[Federal Register Volume 87, Number 226 (Friday, November 25, 2022)]
[Notices]
[Page 72491]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-25644]
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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), as amended by the
Food and Drug 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 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 SKYRIZI (risankizumab-rzaa), approved June 16, 2022,
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), which was added by
FDASIA, 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 for
SKYRIZI (risankizumab-rzaa), approved June 16, 2022, 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 SKYRIZI (risankizumab-rzaa), approved June 16, 2022,
go to the ``[email protected]'' website at https://www.accessdata.fda.gov/scripts/cder/daf/.
Dated: November 18, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-25644 Filed 11-23-22; 8:45 am]
BILLING CODE 4164-01-P
