Notice2024-15998

Determination of Regulatory Review Period for Purposes of Patent Extension; XENPOZYME; Correction

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
July 22, 2024

Issuing agencies

Health and Human Services DepartmentFood and Drug Administration

Abstract

The Food and Drug Administration (FDA or the Agency) is correcting a notice that appeared in the Federal Register of July 2, 2024. The document announced the determination of the regulatory review period for XENPOZYME (olipudase alfa-rpcp) for purposes of patent extension. The document was published with an incorrect patent number. This notice corrects the patent number.

Full Text

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<title>Federal Register, Volume 89 Issue 140 (Monday, July 22, 2024)</title>
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[Federal Register Volume 89, Number 140 (Monday, July 22, 2024)]
[Notices]
[Page 59121]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2024-15998]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket Nos. FDA-2023-E-3130 and FDA-2023-E-3135]


Determination of Regulatory Review Period for Purposes of Patent 
Extension; XENPOZYME; Correction

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; correction.

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SUMMARY: The Food and Drug Administration (FDA or the Agency) is 
correcting a notice that appeared in the Federal Register of July 2, 
2024. The document announced the determination of the regulatory review 
period for XENPOZYME (olipudase alfa-rpcp) for purposes of patent 
extension. The document was published with an incorrect patent number. 
This notice corrects the patent number.

FOR FURTHER INFORMATION CONTACT: Beverly Friedman, Office of Regulatory 
Policy, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 
51, Rm. 6250, Silver Spring, MD 20993, 301-796-3600.

SUPPLEMENTARY INFORMATION: In the Federal Register of Tuesday, July 2, 
2024 (89 FR 54829), appearing on pg. 54830, in the first paragraph of 
the third column, under Section I. Background of the SUPPLEMENTARY 
INFORMATION section, the patent numbers are corrected to read ``U.S. 
Patent Nos. 8,349,319 and 8,658,162.''

    Dated: July 16, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024-15998 Filed 7-19-24; 8:45 am]
BILLING CODE 4164-01-P


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Indexed from Federal Register on July 22, 2024.

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