[Federal Register Volume 84, Number 207 (Friday, October 25, 2019)]
[Notices]
[Pages 57447-57448]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-23252]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2018-N-1262]


Notice of Approval of Product Under Voucher: Rare Pediatric 
Disease Priority Review Voucher

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the 
issuance of approval of a product redeeming a priority review voucher. 
The Federal Food, Drug, and Cosmetic Act (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 issuance of vouchers 
as well as the approval of products redeeming a

[[Page 57448]]

voucher. FDA has determined that an efficacy supplement for DESCOVY 
(emtricitabine and tenofovir alafenamide) approved October 3, 2019, 
meets the redemption criteria.

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-
796-9858, email: althea.cuff@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: Under section 529 of the FD&C Act (21 U.S.C. 
360ff), which was added by FDASIA, FDA will report the issuance of rare 
pediatric disease priority review vouchers and the approval of products 
for which a voucher was redeemed. FDA has determined that an efficacy 
supplement for DESCOVY (emtricitabine and tenofovir alafenamide) 
approved October 3, 2019, meets the redemption criteria.
    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 DESCOVY (emtricitabine and tenofovir alafenamide) 
efficacy supplement approved October 3, 2019, go to the ``[email protected]'' 
website at https://www.accessdata.fda.gov/scripts/cder/daf/.

    Dated: October 21, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-23252 Filed 10-24-19; 8:45 am]
BILLING CODE 4164-01-P


