{"abstract":"The Food and Drug Administration (FDA) is announcing the issuance of an Emergency Use Authorization (EUA) (the Authorization) for an in vitro diagnostic device for detection of the Ebola Zaire virus (detected in the West Africa outbreak in 2014). FDA is issuing this Authorization under the Federal Food, Drug, and Cosmetic Act (the FD&C Act), as requested by the U.S. Department of Defense (DoD). The Authorization contains, among other things, conditions on the emergency use of the authorized in vitro diagnostic device. The Authorization follows the September 22, 2006, determination by then-Secretary of the Department of Homeland Security (DHS), Michael Chertoff, that the Ebola virus presents a material threat against the U.S. population sufficient to affect national security. On the basis of such determination, the Secretary of Health and Human Services (HHS) declared on August 5, 2014, that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection of Ebola virus subject to the terms of any authorization issued under the FD&C Act. The Authorization, which includes an explanation of the reasons for issuance, 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/2014/09/17/2014-22086.html","cfr_references":[],"citation":"79 FR 55804","comment_url":null,"comments_close_on":null,"correction_of":null,"corrections":[],"dates":"The Authorization is effective as of August 5, 2014.","disposition_notes":null,"docket_ids":["Docket No. FDA-2014-N-1206"],"dockets":[],"document_number":"2014-22086","effective_on":"2014-08-05","end_page":55812,"executive_order_notes":null,"executive_order_number":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2014/09/17/2014-22086.xml","html_url":"https://www.federalregister.gov/documents/2014/09/17/2014-22086/authorization-of-emergency-use-of-an-in-vitro-diagnostic-device-for-detection-of-ebola-zaire-virus","images":{"EN17SE14.003":{"large":"https://img.federalregister.gov/EN17SE14.003/EN17SE14.003_large.png","medium":"https://img.federalregister.gov/EN17SE14.003/EN17SE14.003_medium.png","original_size":"https://img.federalregister.gov/EN17SE14.003/EN17SE14.003_original_size.png"},"EN17SE14.002":{"large":"https://img.federalregister.gov/EN17SE14.002/EN17SE14.002_large.png","medium":"https://img.federalregister.gov/EN17SE14.002/EN17SE14.002_medium.png","original_size":"https://img.federalregister.gov/EN17SE14.002/EN17SE14.002_original_size.png"},"EN17SE14.005":{"large":"https://img.federalregister.gov/EN17SE14.005/EN17SE14.005_large.png","medium":"https://img.federalregister.gov/EN17SE14.005/EN17SE14.005_medium.png","original_size":"https://img.federalregister.gov/EN17SE14.005/EN17SE14.005_original_size.png"},"EN17SE14.004":{"large":"https://img.federalregister.gov/EN17SE14.004/EN17SE14.004_large.png","medium":"https://img.federalregister.gov/EN17SE14.004/EN17SE14.004_medium.png","original_size":"https://img.federalregister.gov/EN17SE14.004/EN17SE14.004_original_size.png"},"EN17SE14.007":{"large":"https://img.federalregister.gov/EN17SE14.007/EN17SE14.007_large.png","medium":"https://img.federalregister.gov/EN17SE14.007/EN17SE14.007_medium.png","original_size":"https://img.federalregister.gov/EN17SE14.007/EN17SE14.007_original_size.png"},"EN17SE14.006":{"large":"https://img.federalregister.gov/EN17SE14.006/EN17SE14.006_large.png","medium":"https://img.federalregister.gov/EN17SE14.006/EN17SE14.006_medium.png","original_size":"https://img.federalregister.gov/EN17SE14.006/EN17SE14.006_original_size.png"},"EN17SE14.008":{"large":"https://img.federalregister.gov/EN17SE14.008/EN17SE14.008_large.png","medium":"https://img.federalregister.gov/EN17SE14.008/EN17SE14.008_medium.png","original_size":"https://img.federalregister.gov/EN17SE14.008/EN17SE14.008_original_size.png"}},"images_metadata":{"EN17SE14.003":{"large":{"identifier":"EN17SE14.003","content_type":"image/png","size":145213,"width":823,"sha":"56096f1cbb215bd1c0bba58229d1fb73","url":"https://img.federalregister.gov/EN17SE14.003/EN17SE14.003_large.png","height":1455},"medium":{"identifier":"EN17SE14.003","content_type":"image/png","size":40609,"width":400,"sha":"11a44496ae387d3c180388c70081149e","url":"https://img.federalregister.gov/EN17SE14.003/EN17SE14.003_medium.png","height":707},"original_size":{"identifier":"EN17SE14.003","content_type":"image/png","size":114617,"width":1508,"sha":"88a279560b6f0ce9298a16d9124f0385","url":"https://img.federalregister.gov/EN17SE14.003/EN17SE14.003_original_size.png","height":2667}},"EN17SE14.002":{"large":{"identifier":"EN17SE14.002","content_type":"image/png","size":174579,"width":823,"sha":"ff4e80ef10cf61a2fd95a06a4ff51e75","url":"https://img.federalregister.gov/EN17SE14.002/EN17SE14.002_large.png","height":1148},"medium":{"identifier":"EN17SE14.002","content_type":"image/png","size":63678,"width":507,"sha":"59007af5d30555d1b6d432fa1bdbee4a","url":"https://img.federalregister.gov/EN17SE14.002/EN17SE14.002_medium.png","height":707},"original_size":{"identifier":"EN17SE14.002","content_type":"image/png","size":157491,"width":1912,"sha":"b1c03ea9dc8cd8840cb5243438806778","url":"https://img.federalregister.gov/EN17SE14.002/EN17SE14.002_original_size.png","height":2667}},"EN17SE14.005":{"large":{"identifier":"EN17SE14.005","content_type":"image/png","size":148063,"width":823,"sha":"60f8a190701aa27eec0968e894c66044","url":"https://img.federalregister.gov/EN17SE14.005/EN17SE14.005_large.png","height":1412},"medium":{"identifier":"EN17SE14.005","content_type":"image/png","size":46848,"width":412,"sha":"041c578ce536162eedc7f1fc234afb9d","url":"https://img.federalregister.gov/EN17SE14.005/EN17SE14.005_medium.png","height":707},"original_size":{"identifier":"EN17SE14.005","content_type":"image/png","size":136078,"width":1554,"sha":"25a55caa25d952eff2189d329b3bf908","url":"https://img.federalregister.gov/EN17SE14.005/EN17SE14.005_original_size.png","height":2667}},"EN17SE14.004":{"large":{"identifier":"EN17SE14.004","content_type":"image/png","size":138204,"width":823,"sha":"3eea96b8c78608ffa4d0d6542e7afcac","url":"https://img.federalregister.gov/EN17SE14.004/EN17SE14.004_large.png","height":1337},"medium":{"identifier":"EN17SE14.004","content_type":"image/png","size":45000,"width":435,"sha":"fa6f1dc758dc91dd31f80fa96b35a2d2","url":"https://img.federalregister.gov/EN17SE14.004/EN17SE14.004_medium.png","height":707},"original_size":{"identifier":"EN17SE14.004","content_type":"image/png","size":12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12:15:04 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2014-09-17/pdf/2014-22086.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2014-22086.pdf?1410871505","publication_date":"2014-09-17","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2014/09/17/2014-22086.txt","regulation_id_number_info":{},"regulation_id_numbers":[],"regulations_dot_gov_info":{"supporting_documents":[],"comments_url":"https://www.regulations.gov/docketBrowser?rpp=50&so=DESC&sb=postedDate&po=0&dct=PS&D=FDA-2014-N-1206","supporting_documents_count":0,"docket_id":"FDA-2014-N-1206","regulation_id_number":null,"title":"Authorization of Emergency Use of an In Vitro Diagnostic Device for Detection of Ebola Zaire 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