{"abstract":"The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for EDWARDS SAPIEN 3 TRANSCATHETER PULMONARY VALVE and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of applications to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of patents which claim that medical device.","action":"Notice.","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN SERVICES","name":"Health and Human Services Department","id":221,"url":"https://www.federalregister.gov/agencies/health-and-human-services-department","json_url":"https://www.federalregister.gov/api/v1/agencies/221","parent_id":null,"slug":"health-and-human-services-department"},{"raw_name":"Food and Drug Administration","name":"Food and Drug Administration","id":199,"url":"https://www.federalregister.gov/agencies/food-and-drug-administration","json_url":"https://www.federalregister.gov/api/v1/agencies/199","parent_id":221,"slug":"food-and-drug-administration"}],"body_html_url":"https://www.federalregister.gov/documents/full_text/html/2025/06/25/2025-11601.html","cfr_references":[],"citation":"90 FR 27023","comment_url":null,"comments_close_on":"2025-08-25","correction_of":null,"corrections":[],"dates":"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 August 25, 2025. 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 December 22, 2025. See \"Petitions\" in the SUPPLEMENTARY INFORMATION section for more information.","disposition_notes":null,"docket_ids":["Docket Nos. FDA-2022-E-2187","FDA-2022-E-2190","FDA-2022-E-2191","FDA-2022-E-2192","FDA-2022-E-2193"],"dockets":[{"supporting_documents":[],"agency_name":"FDA","documents":[{"comment_count":0,"comment_start_date":"2025-06-25","updated_at":"2025-08-26T00:07:09.485-04:00","comment_url":"https://www.regulations.gov/commenton/FDA-2022-E-2187-0006","allow_late_comments":false,"id":"FDA-2022-E-2187-0006","comment_end_date":"2025-08-26","regulations_dot_gov_open_for_comment":false}],"supporting_documents_count":0,"id":"FDA-2022-E-2187","title":"Patent Term Extension Application for Edwards SAPIEN® 3 Transcatheter Pulmonary Valve System with Alterra® U.S. Patent No. 10,537,423"},{"supporting_documents":[],"agency_name":"FDA","documents":[{"comment_count":0,"comment_start_date":"2025-06-25","updated_at":"2025-08-26T00:07:10.153-04:00","comment_url":"https://www.regulations.gov/commenton/FDA-2022-E-2190-0006","allow_late_comments":false,"id":"FDA-2022-E-2190-0006","comment_end_date":"2025-08-26","regulations_dot_gov_open_for_comment":false}],"supporting_documents_count":0,"id":"FDA-2022-E-2190","title":"Patent Term Extension Application for Edwards SAPIEN® 3 Transcatheter Pulmonary Valve System with Alterra® U.S. Patent No. 10,413,407"},{"supporting_documents":[],"agency_name":"FDA","documents":[{"comment_count":0,"comment_start_date":"2025-06-25","updated_at":"2025-08-26T00:07:09.829-04:00","comment_url":"https://www.regulations.gov/commenton/FDA-2022-E-2191-0006","allow_late_comments":false,"id":"FDA-2022-E-2191-0006","comment_end_date":"2025-08-26","regulations_dot_gov_open_for_comment":false}],"supporting_documents_count":0,"id":"FDA-2022-E-2191","title":"Patent Term Extension Application for Edwards SAPIEN 3 SAPIEN 3 Transcatheter Pulmonary Valve System with Alterra U.S. Patent No. 10,179,047"},{"supporting_documents":[],"agency_name":"FDA","documents":[{"comment_count":1,"comment_start_date":"2025-06-25","updated_at":"2025-08-26T00:07:09.158-04:00","comment_url":"https://www.regulations.gov/commenton/FDA-2022-E-2192-0006","allow_late_comments":false,"id":"FDA-2022-E-2192-0006","comment_end_date":"2025-08-26","regulations_dot_gov_open_for_comment":false}],"supporting_documents_count":0,"id":"FDA-2022-E-2192","title":"Patent Term Extension Application for Edwards SAPIEN® 3 Edwards SAPIEN® 3 Transcatheter Pulmonary Valve System with Alterra® U.S. Patent No. 9,119,716"},{"supporting_documents":[],"agency_name":"FDA","documents":[{"comment_count":23,"comment_start_date":"2025-06-25","updated_at":"2025-08-26T01:55:55.076-04:00","comment_url":"https://www.regulations.gov/commenton/FDA-2022-E-2193-0006","allow_late_comments":false,"id":"FDA-2022-E-2193-0006","comment_end_date":"2025-08-26","regulations_dot_gov_open_for_comment":false}],"supporting_documents_count":0,"id":"FDA-2022-E-2193","title":"Patent Term Extension Application for 3Edwards SAPIEN® 3 Transcatheter Pulmonary Valve System with Alterra® for U.S. Patent No. 9,393,110"}],"document_number":"2025-11601","effective_on":null,"end_page":27025,"executive_order_notes":null,"executive_order_number":null,"explanation":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2025/06/25/2025-11601.xml","html_url":"https://www.federalregister.gov/documents/2025/06/25/2025-11601/determination-of-regulatory-review-period-for-purposes-of-patent-extension-edwards-sapien-3","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2025-11601?publication_date=2025-06-25","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2025-06-25/2025-11601/mods.xml","not_received_for_publication":null,"page_length":3,"page_views":{"count":101,"last_updated":"2026-04-04 18:15:03 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2025-06-25/pdf/2025-11601.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2025-11601.pdf?1750769110","publication_date":"2025-06-25","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2025/06/25/2025-11601.txt","regulation_id_number_info":{},"regulation_id_numbers":[],"regulations_dot_gov_info":{"supporting_documents":[],"comments_count":23,"agency_id":"FDA","comments_url":"https://www.regulations.gov/docketBrowser?rpp=50&so=DESC&sb=postedDate&po=0&dct=PS&D=FDA-2022-E-2193","supporting_documents_count":0,"docket_id":"FDA-2022-E-2193","document_id":"FDA-2022-E-2193-0006","regulation_id_number":null,"title":"Patent Term Extension Application for 3Edwards SAPIEN® 3 Transcatheter Pulmonary Valve System with Alterra® for U.S. Patent No. 9,393,110","checked_regulationsdotgov_at":"2025-08-27T08:55:03Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":27023,"subtype":null,"title":"Determination of Regulatory Review Period for Purposes of Patent Extension; [EDWARDS SAPIEN 3 TRANSCATHETER PULMONARY VALVE]","toc_doc":"Edwards Sapien 3 Transcatheter Pulmonary Valve","toc_subject":"Determination of Regulatory Review Period for Purposes of Patent Extension","topics":[],"type":"Notice","volume":90}