{"abstract":"The Food and Drug Administration (FDA or Agency) is announcing 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\"). We are soliciting comments on the types of patents currently listed in the Orange Book and the impact that any change to current patent listing practices may have on drug product development. This notice is not intended to communicate our regulatory expectations on these issues but is instead intended to seek early input from the public to inform further regulatory action if determined to be appropriate.","action":"Notice; establishment of a public docket; request for comments.","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/2020/06/01/2020-11684.html","cfr_references":[],"citation":"85 FR 33169","comment_url":null,"comments_close_on":"2020-08-31","correction_of":null,"corrections":[],"dates":"Submit either electronic or written comments by August 31, 2020.","disposition_notes":null,"docket_ids":["Docket No. FDA-2020-N-1127"],"dockets":[{"supporting_documents":[],"agency_name":"FDA","documents":[{"comment_count":17,"comment_start_date":"2020-06-01","updated_at":"2023-03-01T02:50:34.791-05:00","comment_url":"https://www.regulations.gov/commenton/FDA-2020-N-1127-0001","allow_late_comments":null,"id":"FDA-2020-N-1127-0001","comment_end_date":"2020-09-01","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":"2020-11684","effective_on":null,"end_page":33173,"executive_order_notes":null,"executive_order_number":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2020/06/01/2020-11684.xml","html_url":"https://www.federalregister.gov/documents/2020/06/01/2020-11684/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/2020-11684?publication_date=2020-06-01","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2020-06-01/2020-11684/mods.xml","not_received_for_publication":null,"page_length":5,"page_views":{"count":5405,"last_updated":"2026-06-24 04:15:03 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2020-06-01/pdf/2020-11684.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2020-11684.pdf?1590756345","publication_date":"2020-06-01","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2020/06/01/2020-11684.txt","regulation_id_number_info":{},"regulation_id_numbers":[],"regulations_dot_gov_info":{"supporting_documents":[],"comments_count":17,"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-1127-0001","regulation_id_number":null,"title":"Listing of Patent Information in the Orange Book; Establishment of a Public Docket; Request for Comments","checked_regulationsdotgov_at":"2023-03-01T07:50:33Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":33169,"subtype":null,"title":"Listing of Patent Information in the Orange Book; Establishment of a Public Docket; Request for Comments","toc_doc":null,"toc_subject":null,"topics":[],"type":"Notice","volume":85}