{"abstract":"The Food and Drug Administration (FDA) is announcing the revocation of the Emergency Use Authorization (EUA) (the Authorization) issued to Battelle Memorial Institute for the Battelle Critical Care Decontamination System. FDA revoked the Authorization on April 30, 2021, under the Federal Food, Drug, and Cosmetic Act (FD&C Act) as requested by Battelle Memorial Institute on April 2, 2021. 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/2021/05/28/2021-11384.html","cfr_references":[],"citation":"86 FR 28849","comment_url":null,"comments_close_on":null,"correction_of":null,"corrections":[],"dates":"The Authorization for the Battelle Critical Care Decontamination System is revoked as of April 30, 2021.","disposition_notes":null,"docket_ids":["Docket No. FDA-2021-N-0455"],"dockets":[],"document_number":"2021-11384","effective_on":null,"end_page":28851,"executive_order_notes":null,"executive_order_number":null,"explanation":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2021/05/28/2021-11384.xml","html_url":"https://www.federalregister.gov/documents/2021/05/28/2021-11384/revocation-of-authorization-of-emergency-use-of-a-medical-device-during-covid-19-availability","images":{"EN28MY21.011":{"large":"https://img.federalregister.gov/EN28MY21.011/EN28MY21.011_large.png","original_size":"https://img.federalregister.gov/EN28MY21.011/EN28MY21.011_original_size.png"}},"images_metadata":{"EN28MY21.011":{"large":{"identifier":"EN28MY21.011","content_type":"image/png","size":109783,"width":822,"sha":"51a40e90c95fa9705b3c69c7bb7d0362","url":"https://img.federalregister.gov/EN28MY21.011/EN28MY21.011_large.png","height":1130},"original_size":{"identifier":"EN28MY21.011","content_type":"image/png","size":76797,"width":1586,"sha":"ddd6eecde321946bea28d0400a2048f7","url":"https://img.federalregister.gov/EN28MY21.011/EN28MY21.011_original_size.png","height":2180}}},"json_url":"https://www.federalregister.gov/api/v1/documents/2021-11384?publication_date=2021-05-28","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2021-05-28/2021-11384/mods.xml","not_received_for_publication":null,"page_length":3,"page_views":{"count":2758,"last_updated":"2026-04-04 12:15:04 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2021-05-28/pdf/2021-11384.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2021-11384.pdf?1622119547","publication_date":"2021-05-28","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2021/05/28/2021-11384.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-0455","supporting_documents_count":0,"docket_id":"FDA-2021-N-0455","document_id":"FDA-2021-N-0455-0001","regulation_id_number":null,"title":"Revocation of Authorization of Emergency Use of a Medical Device During COVID-19; Availability","checked_regulationsdotgov_at":"2021-05-29T03:30:11Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":28849,"subtype":null,"title":"Revocation of Authorization of Emergency Use of a Medical Device During COVID-19; Availability","toc_doc":"Revocation of Authorization of Emergency Use of a Medical Device During COVID19; Availability","toc_subject":null,"topics":[],"type":"Notice","volume":86}