[Federal Register Volume 82, Number 121 (Monday, June 26, 2017)]
[Notices]
[Page 28860]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-13236]
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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 Brineura (cerliponase alfa) manufactured by
Biomarin Pharmaceuticals 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., Bldg. 22, Rm. 6484, Silver Spring, MD 20993-0002, 301-
796-4061, FAX: 301-796-9858, 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
Brineura (cerliponase alfa) manufactured by Biomarin Pharmaceuticals
Inc., meets the criteria for a priority review voucher. Brineura
(cerliponase alfa) is indicated to slow the progression of loss of
ambulation in symptomatic pediatric patients 3 years of age and older
with late infantile neuronal ceroid lipofuscinosis type 2 (CLN2), also
known as tripeptidyl peptidase 1 (TPP1) deficiency.
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 Brineura (cerliponase alfa) go to the ``Drugs@FDA''
Web site at https://www.accessdata.fda.gov/scripts/cder/daf/.
Dated: June 20, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-13236 Filed 6-23-17; 8:45 am]
BILLING CODE 4164-01-P