{"abstract":"The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled \"Orange Book--Questions and Answers.\" This guidance is intended to assist interested parties (including prospective drug product applicants, drug product applicants, and approved application holders) in utilizing the Approved Drug Products with Therapeutic Equivalence Evaluations (commonly known as the Orange Book). This guidance provides answers to commonly asked questions FDA has received from interested parties regarding the Orange Book.","action":"Notice of availability.","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/2020/06/01/2020-11682.html","cfr_references":[],"citation":"85 FR 33167","comment_url":null,"comments_close_on":"2020-08-31","correction_of":null,"corrections":[],"dates":"Submit either electronic or written comments on the draft guidance by August 31, 2020 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance.","disposition_notes":null,"docket_ids":["Docket No. FDA-2020-D-1068"],"dockets":[{"supporting_documents":[{"title":"Orange Book Questions and Answers Guidance for Industry - Draft","document_id":"FDA-2020-D-1068-0006"},{"title":"Orange Book—Questions and Answers; Guidance for Industry; Availability","document_id":"FDA-2020-D-1068-0005"},{"title":"Orange Book Questions and Answers; Guidance for Industry; Draft Guidance","document_id":"FDA-2020-D-1068-0002"},{"title":"Orange Book—Questions and Answers; Draft Guidance for Industry; Availability","document_id":"FDA-2020-D-1068-0001"}],"agency_name":null,"documents":[{"comment_count":0,"comment_start_date":"2020-06-01","updated_at":"2023-03-01T00:19:42.288-05:00","comment_url":"https://www.regulations.gov/commenton/FDA-2020-D-1068-0001","allow_late_comments":null,"id":"FDA-2020-D-1068-0001","comment_end_date":"2020-09-01","regulations_dot_gov_open_for_comment":false}],"supporting_documents_count":4,"id":"FDA-2020-D-1068","title":"Orange Book – Questions and Answers; Draft Guidance for Industry; Availability"}],"document_number":"2020-11682","effective_on":null,"end_page":33169,"executive_order_notes":null,"executive_order_number":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2020/06/01/2020-11682.xml","html_url":"https://www.federalregister.gov/documents/2020/06/01/2020-11682/orange-book-questions-and-answers-draft-guidance-for-industry-availability","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2020-11682?publication_date=2020-06-01","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2020-06-01/2020-11682/mods.xml","not_received_for_publication":null,"page_length":3,"page_views":{"count":1451,"last_updated":"2026-09-21 00:15:04 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2020-06-01/pdf/2020-11682.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2020-11682.pdf?1590756344","publication_date":"2020-06-01","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2020/06/01/2020-11682.txt","regulation_id_number_info":{},"regulation_id_numbers":[],"regulations_dot_gov_info":{"supporting_documents":[{"title":"Orange Book Questions and Answers Guidance for Industry - Draft","document_id":"FDA-2020-D-1068-0006"},{"title":"Orange Book—Questions and Answers; Guidance for Industry; Availability","document_id":"FDA-2020-D-1068-0005"},{"title":"Orange Book Questions and Answers; Guidance for Industry; Draft Guidance","document_id":"FDA-2020-D-1068-0002"},{"title":"Orange Book—Questions and Answers; Draft Guidance for Industry; Availability","document_id":"FDA-2020-D-1068-0001"}],"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-2020-D-1068","supporting_documents_count":4,"docket_id":"FDA-2020-D-1068","document_id":"FDA-2020-D-1068-0001","regulation_id_number":null,"title":"Orange Book – Questions and Answers; Draft Guidance for Industry; Availability","checked_regulationsdotgov_at":"2023-03-01T05:19:41Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":33167,"subtype":null,"title":"Orange Book-Questions and Answers; Draft Guidance for Industry; Availability","toc_doc":null,"toc_subject":null,"topics":[],"type":"Notice","volume":85}