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

---
identifier: "/us/fr/2024-15998"
source: "fr"
legal_status: "authoritative_unofficial"
title: "Determination of Regulatory Review Period for Purposes of Patent Extension; XENPOZYME; Correction"
title_number: 0
title_name: "Federal Register"
section_number: "2024-15998"
section_name: "Determination of Regulatory Review Period for Purposes of Patent Extension; XENPOZYME; Correction"
positive_law: false
currency: "2024-07-22"
last_updated: "2024-07-22"
format_version: "1.1.0"
generator: "[email protected]"
agency: "Health and Human Services Department"
document_number: "2024-15998"
document_type: "notice"
publication_date: "2024-07-22"
agencies:
  - "Health and Human Services Department"
  - "Food and Drug Administration"
fr_citation: "89 FR 59121"
fr_volume: 89
docket_ids:
  - "Docket Nos. FDA-2023-E-3130 and FDA-2023-E-3135"
fr_action: "Notice; correction."
---


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

**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.