Issuance of Priority Review Voucher; Rare Pediatric Disease Product, 52782 [2022-18519]
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Federal Register / Vol. 87, No. 166 / Monday, August 29, 2022 / Notices
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[FR Doc. 2022–18734 Filed 8–25–22; 4:15 pm]
BILLING CODE 4163–18–P
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:
[FR Doc. 2022–18519 Filed 8–26–22; 8:45 am]
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 ZYNTEGLO
(betibeglogene autotemcel),
manufactured by bluebird bio, 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 ZYNTEGLO (betibeglogene
autotemcel), manufactured by bluebird
bio, Inc., meets the criteria for a priority
review voucher. ZYNTEGLO is
indicated for the treatment of adult and
pediatric patients with +-thalassemia
who require regular red blood cell
transfusions.
For further information about the Rare
Pediatric Disease Priority Review
Voucher Program and for a link to the
SUMMARY:
PO 00000
Dated: August 22, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
Food and Drug Administration,
HHS.
ACTION:
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 ZYNTEGLO,
go to the Center for Biologics Evaluation
and Research’s Approved Cellular and
Gene Therapy Products website at
https://www.fda.gov/vaccines-bloodbiologics/cellular-gene-therapyproducts/approved-cellular-and-genetherapy-products.
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SUMMARY:
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[Federal Register Volume 87, Number 166 (Monday, August 29, 2022)]
[Notices]
[Page 52782]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-18519]
-----------------------------------------------------------------------
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 ZYNTEGLO (betibeglogene autotemcel), manufactured by bluebird bio,
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 ZYNTEGLO (betibeglogene autotemcel),
manufactured by bluebird bio, Inc., meets the criteria for a priority
review voucher. ZYNTEGLO is indicated for the treatment of adult and
pediatric patients with [szlig]-thalassemia who require regular red
blood cell transfusions.
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
ZYNTEGLO, 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: August 22, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-18519 Filed 8-26-22; 8:45 am]
BILLING CODE 4164-01-P
