[Federal Register Volume 86, Number 205 (Wednesday, October 27, 2021)]
[Notices]
[Page 59405]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-23336]


-----------------------------------------------------------------------

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 RETHYMIC (allogeneic processed thymus tissue-agdc), manufactured 
by Enzyvant Therapeutics, GmbH, 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 RETHYMIC (allogeneic processed thymus tissue-
agdc), manufactured by Enzyvant Therapeutics, GmbH, meets the criteria 
for a priority review voucher. RETHYMIC (allogeneic processed thymus 
tissue-agdc) is indicated for immune reconstitution in pediatric 
patients with congenital athymia. RETHYMIC (allogeneic processed thymus 
tissue-agdc) is not indicated for the treatment of patients with severe 
combined immunodeficiency (SCID).
    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 
RETHYMIC (allogeneic processed thymus tissue-agdc), go to the Center 
for Biologics Evaluation and Research 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: October 19, 2021.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2021-23336 Filed 10-26-21; 8:45 am]
BILLING CODE 4164-01-P


