[Federal Register Volume 82, Number 174 (Monday, September 11, 2017)]
[Notices]
[Page 42686]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-19130]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2017-N-0809]


Issuance of Priority Review Voucher; Rare Pediatric Disease 
Product

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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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 (the 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 award of the priority review voucher. 
FDA has determined that KYMRIAH (tisagenlecleucel), manufactured by 
Novartis Pharmaceuticals Corporation, meets the criteria for a priority 
review voucher.

FOR FURTHER INFORMATION CONTACT: Gretchen Opper, 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), which was added by FDASIA, FDA will award priority review 
vouchers to sponsors of approved rare pediatric disease product 
applications that meet certain criteria. FDA has determined that 
KYMRIAH (tisagenlecleucel), manufactured by Novartis Pharmaceuticals 
Corporation, meets the criteria for a priority review voucher. KYMRIAH 
(tisagenlecleucel) is indicated for the treatment of patients up to 25 
years of age with B-cell precursor acute lymphoblastic leukemia (ALL) 
that is refractory or in second or later relapse.
    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 tohttps://www.fda.gov/ForIndustry/DevelopingProductsforRareDiseasesConditions/RarePediatricDiseasePriorityVoucherProgram/default.htm. For further 
information about KYMRIAH (tisagenlecleucel), go to the Center for 
Biologics Evaluation and Research cellular and gene therapy products 
Web site at https://www.fda.gov/BiologicsBloodVaccines/CellularGeneTherapyProducts/ApprovedProducts/default.htm.

    Dated: September 5, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-19130 Filed 9-8-17; 8:45 am]
 BILLING CODE 4164-01-P