United States Government Publishing Office publisher pbl distributor dst United States National Archives and Records Administration Office of the Federal Register author aut Government Organization text government publication eng FR Regulatory Information 2026_register executive 2026-08-15 article Notices D09002ee1e6dc373a D09002ee1e6dc3793 United States Department of Health and Human Services originator org United States Government Agency or Subagency United States Food and Drug Administration originator org United States Government Agency or Subagency The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for BIZENGRI and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that human biological product. 91 FR 53261 https://www.govinfo.gov/app/details/FR-2026-08-17/2026-16713 2026-16713 fr17au26-40 4164-01-P Docket Nos. FDA-2025-E-0485 FDA-2025-E-0486 FDA-2025-E-0488 FDA-2025-E-0489 and FDA-2025-E-0490 https://www.govinfo.gov/app/details/FR-2026-08-17/2026-16713 https://www.govinfo.gov/content/pkg/FR-2026-08-17/html/2026-16713.htm https://www.govinfo.gov/content/pkg/FR-2026-08-17/pdf/2026-16713.pdf 2 p. 53261 53262 91 FR 53261 Determination of Regulatory Review Period for Purposes of Patent Extension; BIZENGRI; Federal Register Vol. 91, Issue NOTICE 2026-16713 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 2026-10-16 Docket Nos. FDA-2025-E-0485 FDA-2025-E-0486 FDA-2025-E-0488 FDA-2025-E-0489 and FDA-2025-E-0490 4164-01-P 2026-16713 Notice.

The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for BIZENGRI and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that human biological product.

Anyone with knowledge that any of the dates as published (see SUPPLEMENTARY INFORMATION) are incorrect may submit either electronic or written comments and ask for a redetermination by October 16, 2026. Furthermore, any interested person may petition FDA for a determination regarding whether the applicant for extension acted with due diligence during the regulatory review period by February 16, 2027. See "Petitions" in the SUPPLEMENTARY INFORMATION section for more information. Patrick Clouser, Office of the Commissioner, Food and Drug Administration, 240-402-5276. Determination of Regulatory Review Period for Purposes of Patent Extension Bizengri, https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf https://www.regulations.gov Vol. 91, no. 157 Office of the Federal Register, National Archives and Records Administration 2026-08-17 continuing daily deposited born digital 184 p. Table of Contents: AE 2.7: GS 4.107: AE 2.106: KF70.A2 https://www.govinfo.gov/app/details/FR-2026-08-17 P0b002ee1e6da2248 0097-6326 0042-1219 0364-1406 769-004-00000-9 000582072 f:fr17au26 https://www.govinfo.gov/app/details/FR-2026-08-17 https://www.govinfo.gov/content/pkg/FR-2026-08-17/pdf/FR-2026-08-17.pdf https://www.govinfo.gov/content/pkg/FR-2026-08-17/xml/FR-2026-08-17.xml fdlp 53181 53356 DGPO 2026-08-15 2026-08-15 FR-2026-08-17 machine generated eng FR FR-2026-08-17 91 157