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.
Issuing agencies
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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