{"abstract":"The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for BRAVECTO 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 U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that animal drug product.","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/2018/02/12/2018-02761.html","cfr_references":[],"citation":"83 FR 6033","comment_url":null,"comments_close_on":"2018-08-13","correction_of":null,"corrections":[],"dates":"Anyone with knowledge that any of the dates as published (see the SUPPLEMENTARY INFORMATION section) are incorrect may submit either electronic or written comments and ask for a redetermination by April 13, 2018. 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 August 13, 2018. See \"Petitions\" in the SUPPLEMENTARY INFORMATION section for more information.","disposition_notes":null,"docket_ids":["Docket No. FDA-2015-E-2079"],"dockets":[{"supporting_documents":[],"agency_name":"FDA","documents":[{"comment_count":0,"comment_start_date":"2018-02-12","updated_at":"2023-03-01T01:46:15.912-05:00","comment_url":"https://www.regulations.gov/commenton/FDA-2015-E-2079-0007","allow_late_comments":null,"id":"FDA-2015-E-2079-0007","comment_end_date":"2018-04-14","regulations_dot_gov_open_for_comment":false}],"supporting_documents_count":0,"id":"FDA-2015-E-2079","title":"Patent Extension Application for BRAVECTO® Patent No. 7,662,972"}],"document_number":"2018-02761","effective_on":null,"end_page":6034,"executive_order_notes":null,"executive_order_number":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2018/02/12/2018-02761.xml","html_url":"https://www.federalregister.gov/documents/2018/02/12/2018-02761/determination-of-regulatory-review-period-for-purposes-of-patent-extension-bravecto","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2018-02761?publication_date=2018-02-12","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2018-02-12/2018-02761/mods.xml","not_received_for_publication":null,"page_length":2,"page_views":{"count":1358,"last_updated":"2026-10-23 00:15:04 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2018-02-12/pdf/2018-02761.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2018-02761.pdf?1518183988","publication_date":"2018-02-12","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2018/02/12/2018-02761.txt","regulation_id_number_info":{},"regulation_id_numbers":[],"regulations_dot_gov_info":{"supporting_documents":[],"comments_count":0,"agency_id":"FDA","comments_url":"https://www.regulations.gov/docketBrowser?rpp=50&so=DESC&sb=postedDate&po=0&dct=PS&D=FDA-2015-E-2079","supporting_documents_count":0,"docket_id":"FDA-2015-E-2079","document_id":"FDA-2015-E-2079-0007","regulation_id_number":null,"title":"Patent Extension Application for BRAVECTO® Patent No. 7,662,972","checked_regulationsdotgov_at":"2023-03-01T06:46:15Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":6033,"subtype":null,"title":"Determination of Regulatory Review Period for Purposes of Patent Extension; BRAVECTO","toc_doc":"BRAVECTO","toc_subject":"Determinations of Regulatory Review Periods for Purposes of Patent Extensions:","topics":[],"type":"Notice","volume":83}