{"abstract":"The Food and Drug Administration (FDA or Agency) announced the completion of the first phase of the enhanced Purple Book on February 24, 2020. FDA is transitioning the current table format \"Purple Book: Lists of Licensed Biological Products with Reference Product Exclusivity and Biosimilarity or Interchangeability Evaluations\" to a searchable, public-facing online database entitled \"Purple Book: Database of FDA-Licensed Biological Products.\" FDA is establishing a docket for public comment to gather stakeholder feedback on the new database to inform the next phase of development.","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/2020/03/05/2020-04539.html","cfr_references":[],"citation":"85 FR 12927","comment_url":null,"comments_close_on":"2020-05-04","correction_of":null,"corrections":[],"dates":"Submit either electronic or written comments by May 4, 2020. FDA is establishing a docket for public comment. The docket number is FDA- 2020-N-0437. The docket will close on May 4, 2020.","disposition_notes":null,"docket_ids":["Docket No. FDA-2020-N-0437"],"dockets":[{"supporting_documents":[],"agency_name":"FDA","documents":[{"comment_count":9,"comment_start_date":"2020-03-05","updated_at":"2023-02-28T13:43:58.696-05:00","comment_url":"https://www.regulations.gov/commenton/FDA-2020-N-0437-0001","allow_late_comments":null,"id":"FDA-2020-N-0437-0001","comment_end_date":"2020-05-05","regulations_dot_gov_open_for_comment":false}],"supporting_documents_count":0,"id":"FDA-2020-N-0437","title":"Purple Book Enhancement; Establishment of a Public Docket; Request for Comments"}],"document_number":"2020-04539","effective_on":null,"end_page":12928,"executive_order_notes":null,"executive_order_number":null,"explanation":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2020/03/05/2020-04539.xml","html_url":"https://www.federalregister.gov/documents/2020/03/05/2020-04539/purple-book-enhancement-establishment-of-a-public-docket-request-for-comments","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2020-04539?publication_date=2020-03-05","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2020-03-05/2020-04539/mods.xml","not_received_for_publication":null,"page_length":2,"page_views":{"count":838,"last_updated":"2026-04-04 14:15:05 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2020-03-05/pdf/2020-04539.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2020-04539.pdf?1583329529","publication_date":"2020-03-05","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2020/03/05/2020-04539.txt","regulation_id_number_info":{},"regulation_id_numbers":[],"regulations_dot_gov_info":{"supporting_documents":[],"comments_count":9,"agency_id":"FDA","comments_url":"https://www.regulations.gov/docketBrowser?rpp=50&so=DESC&sb=postedDate&po=0&dct=PS&D=FDA-2020-N-0437","supporting_documents_count":0,"docket_id":"FDA-2020-N-0437","document_id":"FDA-2020-N-0437-0001","regulation_id_number":null,"title":"Purple Book Enhancement; Establishment of a Public Docket; Request for Comments","checked_regulationsdotgov_at":"2023-02-28T18:43:57Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":12927,"subtype":null,"title":"Purple Book Enhancement; Establishment of a Public Docket; Request for Comments","toc_doc":null,"toc_subject":null,"topics":[],"type":"Notice","volume":85}