Notice2021-21823
Issuance of Priority Review Voucher; Rare Pediatric Disease Product; Withdrawal
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
October 6, 2021
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
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 The Federal Register notice was published in error and is being withdrawn.
Full Text
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<title>Federal Register, Volume 86 Issue 191 (Wednesday, October 6, 2021)</title>
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[Federal Register Volume 86, Number 191 (Wednesday, October 6, 2021)]
[Notices]
[Page 55619]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2021-21823]
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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.
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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notice was published in error and is being withdrawn.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Register notice was published in error and is being withdrawn.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
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</html>Indexed from Federal Register on October 6, 2021.
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