Document ID: FDA-2020-N-0026-0014
Agency: fda
Document Type: Notice
Title: Issuance of Priority Review Voucher;
Rare Pediatric Disease Product;
Withdrawal
Posted Date: 2021-10-06T04:00Z

[Federal Register Volume 86, Number 191 (Wednesday, October 6, 2021)]
[Notices]
[Page 55619]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-21823]

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

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; Withdrawal

AGENCY: Food and Drug Administration, Health and Human Services (HHS).

ACTION: Notice; withdrawal.

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

SUMMARY: The Food and Drug Administration (FDA) is withdrawing the 
notice that published in the Federal Register of September 30, 2021, 
that announced the issuance of a priority review voucher to the sponsor 
of a rare pediatric disease product application. The Federal Register 
notice was published in error and is being withdrawn.

FOR FURTHER INFORMATION CONTACT: Stephen Ripley, 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: In the Federal Register of September 30, 
2021 (86 FR 54219) in FR Doc. 2021-21311, FDA announced the issuance of 
a priority review voucher to the sponsor of a rare pediatric disease 
product application for RETHYMIC (allogeneic processed thymus tissue-
agdc), manufactured by Enzyvant Therapeutics, GmbH. The Federal 
Register notice was published in error and is being withdrawn.

    Dated: October 1, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-21823 Filed 10-5-21; 8:45 am]
BILLING CODE 4164-01-P