{"abstract":"The Food and Drug Administration (FDA or the Agency) is reopening the comment period for the notice entitled \"Listing of Patent Information in the Orange Book; Establishment of a Public Docket; Request for Comments\" that appeared in the Federal Register of June 1, 2020. The notice announced the establishment of a docket to solicit comments on the listing of patent information in the FDA publication \"Approved Drug Products With Therapeutic Equivalence Evaluations\" (commonly known as the \"Orange Book\"). The Agency is taking this action in response to the recently enacted Orange Book Transparency Act of 2020, which was signed into law on January 5, 2021.","action":"Notice; reopening of comment period.","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/2021/03/16/2021-05327.html","cfr_references":[],"citation":"86 FR 14450","comment_url":null,"comments_close_on":"2021-05-15","correction_of":null,"corrections":[],"dates":"FDA is reopening the comment period for the notice published on June 1, 2020 (85 FR 33169). Submit either electronic or written comments by April 15, 2021.","disposition_notes":null,"docket_ids":["Docket No. FDA-2020-N-1127"],"dockets":[{"supporting_documents":[],"agency_name":"FDA","documents":[{"comment_count":4,"comment_start_date":"2021-03-16","updated_at":"2023-02-28T22:35:14.524-05:00","comment_url":"https://www.regulations.gov/commenton/FDA-2020-N-1127-0024","allow_late_comments":null,"id":"FDA-2020-N-1127-0024","comment_end_date":"2021-04-16","regulations_dot_gov_open_for_comment":false}],"supporting_documents_count":0,"id":"FDA-2020-N-1127","title":"Listing of Patent Information in the Orange Book; Establishment of a Public Docket; Request for Comments"}],"document_number":"2021-05327","effective_on":null,"end_page":14451,"executive_order_notes":null,"executive_order_number":null,"explanation":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2021/03/16/2021-05327.xml","html_url":"https://www.federalregister.gov/documents/2021/03/16/2021-05327/listing-of-patent-information-in-the-orange-book-establishment-of-a-public-docket-request-for","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2021-05327?publication_date=2021-03-16","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2021-03-16/2021-05327/mods.xml","not_received_for_publication":null,"page_length":2,"page_views":{"count":529,"last_updated":"2026-04-24 16:15:04 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2021-03-16/pdf/2021-05327.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2021-05327.pdf?1615812316","publication_date":"2021-03-16","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2021/03/16/2021-05327.txt","regulation_id_number_info":{},"regulation_id_numbers":[],"regulations_dot_gov_info":{"supporting_documents":[],"comments_count":4,"agency_id":"FDA","comments_url":"https://www.regulations.gov/docketBrowser?rpp=50&so=DESC&sb=postedDate&po=0&dct=PS&D=FDA-2020-N-1127","supporting_documents_count":0,"docket_id":"FDA-2020-N-1127","document_id":"FDA-2020-N-1127-0024","regulation_id_number":null,"title":"Listing of Patent Information in the Orange Book; Establishment of a Public Docket; Request for Comments","checked_regulationsdotgov_at":"2023-03-01T03:35:13Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":14450,"subtype":null,"title":"Listing of Patent Information in the Orange Book; Establishment of a Public Docket; Request for Comments; Reopening of Comment Period","toc_doc":"Listing of Patent Information in the Orange Book","toc_subject":"Request for Comments:\n","topics":[],"type":"Notice","volume":86}