Document

Issuance of Priority Review Voucher; Rare Pediatric Disease Product; Withdrawal

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 v...

Department of Health and Human Services
Food and Drug Administration
  1. [Docket No. FDA-2020-N-0026]

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 The Federal Register notice was published in error and is being withdrawn.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 The Federal Register notice was published in error and is being withdrawn.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

Legal Citation

Federal Register Citation

Use this for formal legal and research references to the published document.

86 FR 55619

Web Citation

Suggested Web Citation

Use this when citing the archival web version of the document.

“Issuance of Priority Review Voucher; Rare Pediatric Disease Product; Withdrawal,” thefederalregister.org (October 6, 2021), https://thefederalregister.org/documents/2021-21823/issuance-of-priority-review-voucher-rare-pediatric-disease-product-withdrawal.