82 FR 59622 - Issuance of Priority Review Voucher; Rare Pediatric Disease Product

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 82, Issue 240 (December 15, 2017)

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 MEPSEVII (vestronidase alfa-vjbk), manufactured by Ultragenyx Pharmaceutical, Inc., meets the criteria for a priority review voucher.

[Federal Register Volume 82, Number 240 (Friday, December 15, 2017)]
[Notices]
[Pages 59622-59623]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2017-27049]


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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

[[Page 59623]]

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 MEPSEVII (vestronidase 
alfa-vjbk), manufactured by Ultragenyx Pharmaceutical, Inc., meets the 
criteria for a priority review voucher.

FOR FURTHER INFORMATION CONTACT: Althea Cuff, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Silver Spring, MD 20993-0002, 301-796-4061, Fax: 301-
796-9856, 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), 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 
MEPSEVII (vestronidase alfa-vjbk), manufactured by Ultragenyx 
Pharmaceutical, Inc., meets the criteria for a priority review voucher. 
MEPSEVII (vestronidase alfa-vjbk) is indicated for the treatment of 
Mucopolysaccharidosis type VII (MPS VII, Sly Syndrome).
    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 MEPSEVII (vestronidase alfa-vjbk), go to the 
``Drugs@FDA'' website at https://www.accessdata.fda.gov/scripts/cder/daf/.

    Dated: December 12, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017-27049 Filed 12-14-17; 8:45 am]
 BILLING CODE 4164-01-P