{"abstract":"The Food and Drug Administration (FDA or Agency) is announcing the establishment of a public docket to solicit comments on FDA's publication entitled \"Approved Drug Products With Therapeutic Equivalence Evaluations\" (commonly known as the \"Orange Book\"). The Orange Book identifies drug products approved by FDA under the Federal Food, Drug, and Cosmetic Act (FD&C Act) and includes related information. As part of FDA's Drug Competition Action Plan and our continued effort to improve transparency and provide useful information to regulated industry and the public, we are seeking comments on how stakeholders and the public use the Orange Book and whether it can be improved.","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/2020/06/01/2020-11683.html","cfr_references":[],"citation":"85 FR 33165","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-1069"],"dockets":[{"supporting_documents":[],"agency_name":"FDA","documents":[{"comment_count":17,"comment_start_date":"2020-06-01","updated_at":"2023-03-01T00:20:43.144-05:00","comment_url":"https://www.regulations.gov/commenton/FDA-2020-N-1069-0001","allow_late_comments":null,"id":"FDA-2020-N-1069-0001","comment_end_date":"2020-09-01","regulations_dot_gov_open_for_comment":false}],"supporting_documents_count":0,"id":"FDA-2020-N-1069","title":"Approved Drug Products With Therapeutic Equivalence Evaluations (the Orange Book); Establishment of a Public Docket; Request for Comments"}],"document_number":"2020-11683","effective_on":null,"end_page":33167,"executive_order_notes":null,"executive_order_number":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2020/06/01/2020-11683.xml","html_url":"https://www.federalregister.gov/documents/2020/06/01/2020-11683/approved-drug-products-with-therapeutic-equivalence-evaluations-the-orange-book-establishment-of-a","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2020-11683?publication_date=2020-06-01","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2020-06-01/2020-11683/mods.xml","not_received_for_publication":null,"page_length":3,"page_views":{"count":3650,"last_updated":"2026-09-21 10:15:07 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2020-06-01/pdf/2020-11683.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2020-11683.pdf?1590756345","publication_date":"2020-06-01","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2020/06/01/2020-11683.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-1069","supporting_documents_count":0,"docket_id":"FDA-2020-N-1069","document_id":"FDA-2020-N-1069-0001","regulation_id_number":null,"title":"Approved Drug Products With Therapeutic Equivalence Evaluations (the Orange Book); Establishment of a Public Docket; Request for Comments","checked_regulationsdotgov_at":"2023-03-01T05:20:42Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":33165,"subtype":null,"title":"Approved Drug Products With Therapeutic Equivalence Evaluations (the “Orange Book”); Establishment of a Public Docket; Request for Comments","toc_doc":null,"toc_subject":null,"topics":[],"type":"Notice","volume":85}