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 The Federal Register notice was published in error and is being withdrawn.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 The Federal Register notice was published in error and is being withdrawn.