Issuance of Priority Review Voucher; Rare Pediatric Disease Product, 1097 [2024-00263]
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Federal Register / Vol. 89, No. 6 / Tuesday, January 9, 2024 / Notices
Responses: 30; Total Annual Hours:
1,790. (For policy questions regarding
this collection contact: Beverly Boston
at 410–786–4186.)
3. Title of Information Collection:
Behavioral Health Clinic Quality Data
Reporting; Type of Information
Collection Request: Revision of an active
collection of information request; Use:
This Information Collection concerns
the Behavioral Health Clinic Quality
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‘‘Reporting Template’’ or ‘‘Template’’),
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Respondents: 429; Total Annual
Responses: 1,009; Total Annual Hours:
6,814. (For policy questions regarding
this collection contact: Beverly Boston
at 410–786–4186.)
Dated: January 4, 2024.
William N. Parham, III,
Director, Division of Information Collections
and Regulatory Impacts, Office of Strategic
Operations and Regulatory Affairs.
[FR Doc. 2024–00205 Filed 1–8–24; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
khammond on DSKJM1Z7X2PROD with NOTICES
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:
16:38 Jan 08, 2024
FOR FURTHER INFORMATION CONTACT:
Myrna Hanna, Center for Biologics
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 71, Rm. 7301,
Silver Spring, MD 20993–0002, 240–
402–7911.
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 CASGEVY (exagamglogene
autotemcel), manufactured by Vertex
Pharmaceuticals, Inc., meets the criteria
for a priority review voucher.
CASGEVY (exagamglogene
autotemcel) is indicated for treatment of
sickle cell disease in patients 12 years
of age and older with recurrent vasoocclusive crises.
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/industry/
developing-products-rare-diseasesconditions/rare-pediatric-disease-rpddesignation-and-voucher-programs. For
further information about CASGEVY
(exagamglogene autotemcel), go to the
Center for Biologics Evaluation and
Research’s Approved Cellular and Gene
Therapy Products website at https://
www.fda.gov/vaccines-blood-biologics/
cellular-gene-therapy-products/
approved-cellular-and-gene-therapyproducts.
SUPPLEMENTARY INFORMATION:
Dated: January 4, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024–00263 Filed 1–8–24; 8:45 am]
Notice.
VerDate Sep<11>2014
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 CASGEVY
(exagamglogene autotemcel),
manufactured by Vertex
Pharmaceuticals, Inc., meets the criteria
for a priority review voucher.
SUMMARY:
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1097
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2014–N–0987]
Agency Information Collection
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for the Collection of Qualitative Data
on Tobacco Products and
Communications
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E:\FR\FM\09JAN1.SGM
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]]>Agencies
[Federal Register Volume 89, Number 6 (Tuesday, January 9, 2024)]
[Notices]
[Page 1097]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-00263]
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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 the priority review voucher. FDA has determined
that CASGEVY (exagamglogene autotemcel), manufactured by Vertex
Pharmaceuticals, Inc., meets the criteria for a priority review
voucher.
FOR FURTHER INFORMATION CONTACT: Myrna Hanna, Center for Biologics
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 71, Rm. 7301, Silver Spring, MD 20993-0002, 240-
402-7911.
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 CASGEVY (exagamglogene autotemcel),
manufactured by Vertex Pharmaceuticals, Inc., meets the criteria for a
priority review voucher.
CASGEVY (exagamglogene autotemcel) is indicated for treatment of
sickle cell disease in patients 12 years of age and older with
recurrent vaso-occlusive crises.
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/industry/developing-products-rare-diseases-conditions/rare-pediatric-disease-rpd-designation-and-voucher-programs. For further information about CASGEVY
(exagamglogene autotemcel), go to the Center for Biologics Evaluation
and Research's Approved Cellular and Gene Therapy Products website at
https://www.fda.gov/vaccines-blood-biologics/cellular-gene-therapy-products/approved-cellular-and-gene-therapy-products.
Dated: January 4, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024-00263 Filed 1-8-24; 8:45 am]
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