{"abstract":"The Food and Drug Administration (FDA) has determined the regulatory review period for VALCYTE 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 Patents and Trademarks, Department of Commerce, for the extension of a patent that claims that human 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/2003/02/19/03-3872.html","cfr_references":[],"citation":"68 FR 8027","comment_url":null,"comments_close_on":null,"correction_of":null,"corrections":[],"dates":null,"disposition_notes":null,"docket_ids":["Docket No. 01E-0403"],"dockets":[],"document_number":"03-3872","effective_on":null,"end_page":8028,"executive_order_notes":null,"executive_order_number":null,"explanation":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2003/02/19/03-3872.xml","html_url":"https://www.federalregister.gov/documents/2003/02/19/03-3872/determination-of-regulatory-review-period-for-purposes-of-patent-extension-valcyte","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/03-3872?publication_date=2003-02-19","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2003-02-19/03-3872/mods.xml","not_received_for_publication":null,"page_length":2,"page_views":{"count":38,"last_updated":"2026-04-04 18:15:03 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2003-02-19/pdf/03-3872.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":null,"publication_date":"2003-02-19","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2003/02/19/03-3872.txt","regulation_id_number_info":{},"regulation_id_numbers":[],"regulations_dot_gov_info":{},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":8027,"subtype":null,"title":"Determination of Regulatory Review Period for Purposes of Patent Extension; VALCYTE","toc_doc":"VALCYTE","toc_subject":"Human drugs:","topics":[],"type":"Notice","volume":68}