86 FR 191 pg. 55619 - Issuance of Priority Review Voucher; Rare Pediatric Disease Product; Withdrawal
Type: NOTICEVolume: 86Number: 191Page: 55619
Page: 55619Docket number: [Docket No. FDA-2020-N-0026]
FR document: [FR Doc. 2021-21823 Filed 10-5-21; 8:45 am]
Agency: Health and Human Services Department
Sub Agency: Food and Drug Administration
Official PDF Version: PDF Version
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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 The Federal Register notice was published in error and is being withdrawn.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 The Federal Register notice was published in error and is being withdrawn.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]
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