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

---
identifier: "/us/fr/2021-21823"
source: "fr"
legal_status: "authoritative_unofficial"
title: "Issuance of Priority Review Voucher; Rare Pediatric Disease Product; Withdrawal"
title_number: 0
title_name: "Federal Register"
section_number: "2021-21823"
section_name: "Issuance of Priority Review Voucher; Rare Pediatric Disease Product; Withdrawal"
positive_law: false
currency: "2021-10-06"
last_updated: "2021-10-06"
format_version: "1.1.0"
generator: "[email protected]"
agency: "Health and Human Services Department"
document_number: "2021-21823"
document_type: "notice"
publication_date: "2021-10-06"
agencies:
  - "Health and Human Services Department"
  - "Food and Drug Administration"
fr_citation: "86 FR 55619"
fr_volume: 86
docket_ids:
  - "Docket No. FDA-2020-N-0026"
fr_action: "Notice; withdrawal."
---


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 The *Federal Register* notice was published in error and is being withdrawn.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 The *Federal Register* notice was published in error and is being withdrawn.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