{"abstract":"The Food and Drug Administration (FDA or Agency) is announcing the revocation of the Emergency Use Authorization (EUA) (the Authorization) issued to Janssen Biotech, Inc. (Janssen), for the Janssen COVID-19 Vaccine. FDA revoked the Authorization on June 1, 2023, under the Federal Food, Drug, and Cosmetic Act (FD&C Act). The revocation, which includes an explanation of the reasons for the revocation, is reprinted in this document.","action":"Notice.","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/2024/10/15/2024-23637.html","cfr_references":[],"citation":"89 FR 83021","comment_url":null,"comments_close_on":null,"correction_of":null,"corrections":[],"dates":"The Authorization is revoked as of June 1, 2023.","disposition_notes":null,"docket_ids":["Docket No. FDA-2021-N-0335"],"dockets":[{"supporting_documents":[],"agency_name":"FDA","documents":[{"comment_count":0,"comment_start_date":null,"updated_at":"2024-10-15T14:56:16.436-04:00","comment_url":"https://www.regulations.gov/commenton/FDA-2021-N-0335-0006","allow_late_comments":false,"id":"FDA-2021-N-0335-0006","comment_end_date":null,"regulations_dot_gov_open_for_comment":false}],"supporting_documents_count":0,"id":"FDA-2021-N-0335","title":"Authorizations of Emergency Use of Certain Biological Products During the COVID-19 Pandemic; Availability"}],"document_number":"2024-23637","effective_on":null,"end_page":83023,"executive_order_notes":null,"executive_order_number":null,"explanation":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2024/10/15/2024-23637.xml","html_url":"https://www.federalregister.gov/documents/2024/10/15/2024-23637/revocation-of-emergency-use-of-a-biological-product-during-the-covid-19-pandemic-availability","images":{"EN15OC24.037":{"large":"https://img.federalregister.gov/EN15OC24.037/EN15OC24.037_large.png","medium":"https://img.federalregister.gov/EN15OC24.037/EN15OC24.037_medium.png","original_size":"https://img.federalregister.gov/EN15OC24.037/EN15OC24.037_original_size.png"}},"images_metadata":{"EN15OC24.037":{"large":{"identifier":"EN15OC24.037","content_type":"image/png","size":117279,"width":823,"sha":"7ac4fc551cddb46ac63e9d877f4d5c61","url":"https://img.federalregister.gov/EN15OC24.037/EN15OC24.037_large.png","height":1173},"medium":{"identifier":"EN15OC24.037","content_type":"image/png","size":49231,"width":491,"sha":"d8318bc828d3243dabaddc15bf4023c8","url":"https://img.federalregister.gov/EN15OC24.037/EN15OC24.037_medium.png","height":700},"original_size":{"identifier":"EN15OC24.037","content_type":"image/png","size":137043,"width":1856,"sha":"4de50e18082dea5f8d4e85d0ae8e96c5","url":"https://img.federalregister.gov/EN15OC24.037/EN15OC24.037_original_size.png","height":2645}}},"json_url":"https://www.federalregister.gov/api/v1/documents/2024-23637?publication_date=2024-10-15","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2024-10-15/2024-23637/mods.xml","not_received_for_publication":null,"page_length":3,"page_views":{"count":502,"last_updated":"2026-04-04 14:15:05 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2024-10-15/pdf/2024-23637.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2024-23637.pdf?1728650734","publication_date":"2024-10-15","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2024/10/15/2024-23637.txt","regulation_id_number_info":{},"regulation_id_numbers":[],"regulations_dot_gov_info":{"supporting_documents":[],"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-2021-N-0335","supporting_documents_count":0,"docket_id":"FDA-2021-N-0335","document_id":"FDA-2021-N-0335-0006","regulation_id_number":null,"title":"Authorizations of Emergency Use of Certain Biological Products During the COVID-19 Pandemic; Availability","checked_regulationsdotgov_at":"2024-10-16T18:00:18Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":83021,"subtype":null,"title":"Revocation of Emergency Use of a Biological Product During the COVID-19 Pandemic; Availability","toc_doc":"Biological Product during the COVID-19 Pandemic; Revocation","toc_subject":"Emergency Use Authorization","topics":[],"type":"Notice","volume":89}