Issuance of Priority Review Voucher; Rare Pediatric Disease Product, 61598 [2023-19287]
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61598
Federal Register / Vol. 88, No. 172 / Thursday, September 7, 2023 / Notices
Estimated Total Annual Burden
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Authority: Sec. 5106, Public Law 111–
320, the Child Abuse Prevention and
Treatment Act Reauthorization Act of
2010, and titles IV–B and IV–E of the
Social Security Act.
Mary B. Jones,
ACF/OPRE Certifying Officer.
[FR Doc. 2023–19228 Filed 9–6–23; 8:45 am]
BILLING CODE 4184–29–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
Dated: September 1, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[Docket No. FDA–2023–N–2607]
Issuance of Priority Review Voucher;
Rare Pediatric Disease Product
AGENCY:
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Notice.
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 the priority review voucher. FDA has
determined that VEOPOZ (pozelimabbbfg), manufactured by Regeneron
Pharmaceuticals, Inc., 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, email: Cathryn.Lee@
fda.hhs.gov.
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 VEOPOZ (pozelimab-bbfg),
approved on August 18, 2023, and
manufactured by Regeneron
Pharmaceuticals, Inc., meets the criteria
for a priority review voucher. VEOPOZ
(pozelimab-bbfg) injection is indicated
for the treatment of adult and pediatric
patients 1 year of age and older with
CD55-deficient protein-losing
SUMMARY:
ddrumheller on DSK120RN23PROD with NOTICES1
[FR Doc. 2023–19287 Filed 9–6–23; 8:45 am]
Food and Drug Administration,
HHS.
ACTION:
enteropathy (PLE), also known as
CHAPLE disease.
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/
DevelopingProducts
forRareDiseasesConditions/
RarePediatricDiseasePriority
VoucherProgram/default.htm. For
further information about VEOPOZ
(pozelimab-bbfg), go to the ‘‘Drugs@
FDA’’ website at https://
www.accessdata.fda.gov/scripts/cder/
daf/.
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Food and Drug Administration
[Docket No. FDA–2023–N–1190]
Cellular, Tissue, and Gene Therapies
Advisory Committee; Notice of
Meeting; Establishment of a Public
Docket; Request for Comments—
Sickle Cell Disease
AGENCY:
Food and Drug Administration,
HHS.
Notice; establishment of a
public docket; request for comments.
ACTION:
The Food and Drug
Administration (FDA) announces a
forthcoming public advisory committee
meeting of the Cellular, Tissue, and
Gene Therapies Advisory Committee
(the Committee). The general function of
the Committee is to provide advice and
recommendations to FDA on regulatory
issues. On October 31, 2023, the
Committee will discuss and make
recommendations on biologics license
application (BLA) 125787 from Vertex
Pharmaceuticals, Inc. for exagamglogene
autotemcel (exa-cel). The applicant has
requested an indication for the
treatment of sickle cell disease in
patients 12 years and older with
recurrent vaso-occlusive crises. The
meeting will be open to the public. FDA
is establishing a docket for public
comment on this document.
DATES: The meeting will be held on
October 31, 2023, from 9 a.m. to 5 p.m.
Eastern Time.
ADDRESSES: All meeting participants
will be heard, viewed, captioned, and
recorded for this advisory committee
meeting via an online teleconferencing
SUMMARY:
PO 00000
Frm 00100
Fmt 4703
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and/or video conferencing platform.
Answers to commonly asked questions
about FDA advisory committee meetings
may be accessed at: https://
www.fda.gov/AdvisoryCommittees/
AboutAdvisoryCommittees/
ucm408555.htm.
The online web conference meeting
will be available at the following link on
the day of the meeting at https://
youtube.com/live/M90IjjxOdQg.
FDA is establishing a docket for
public comment on this meeting. The
docket number is FDA–2023–N–1190.
The docket will close on October 30,
2023. 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 October 30, 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
October 24, 2023, will be provided to
the Committee. Comments received after
that date and on October 30, 2023, 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
confidential information that you or a
third party may not wish to be posted,
such as medical information, your or
anyone else’s Social Security number, or
confidential business information, such
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do not wish to be made available to the
public, submit the comment as a
written/paper submission and in the
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07SEN1
]]>Agencies
[Federal Register Volume 88, Number 172 (Thursday, September 7, 2023)]
[Notices]
[Page 61598]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-19287]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2023-N-2607]
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 the priority review voucher. FDA has determined
that VEOPOZ (pozelimab-bbfg), manufactured by Regeneron
Pharmaceuticals, Inc., 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, email:
[email protected].
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 VEOPOZ (pozelimab-bbfg), approved on August 18,
2023, and manufactured by Regeneron Pharmaceuticals, Inc., meets the
criteria for a priority review voucher. VEOPOZ (pozelimab-bbfg)
injection is indicated for the treatment of adult and pediatric
patients 1 year of age and older with CD55-deficient protein-losing
enteropathy (PLE), also known as CHAPLE disease.
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 VEOPOZ (pozelimab-bbfg), go to the ``Drugs@FDA''
website at https://www.accessdata.fda.gov/scripts/cder/daf/.
Dated: September 1, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-19287 Filed 9-6-23; 8:45 am]
BILLING CODE 4164-01-P
