2024-15998. Determination of Regulatory Review Period for Purposes of Patent Extension; XENPOZYME; Correction

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Department of Health and Human Services

Food and Drug Administration

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

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice; correction.

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.