{"id":"FED-181","kind":"order","level":"federal","jurisdiction":"United States","state":"","metro":"","industry":"","agency":"","eco":"","issuer":"Secretary of Health and Human Services","authority":"Federal Food, Drug, and Cosmetic Act § 564 (21 U.S.C. § 360bbb-3)","instrument":"Determination of Public Health Emergency and Declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for 2019-nCoV","title":"Determination of Public Health Emergency, 85 Fed. Reg. 7316 (Feb. 7, 2020)","dateIssued":"2020-02-04","effective":"2020-02-04 (\u0027The determination and declaration took effect February 4, 2020\u0027)","end":"through the § 564 emergency (terminated 2024-2025; not verified)","startDate":"2020-02-04","endDate":"2021-09-30","quarters":["2020Q2","2020Q3","2020Q4","2021Q1","2021Q2","2021Q3"],"types":["EMER","HC"],"addressees":["FDA; manufacturers and laboratories of COVID-19 diagnostics"],"clause":"On February 4, 2020, the Secretary determined pursuant to his authority under section 564 of the FD\u0026C Act that there is a public health emergency that has a significant potential to affect national security or the health and security of United States citizens living abroad and that involves a novel (new) coronavirus (nCoV) first detected in Wuhan City, Hubei Province, China in 2019 (2019-nCoV). On the basis of this determination, he also declared that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection and/or diagnosis of this novel coronavirus (2019-nCoV) pursuant to section 564 of the FD\u0026C Act","enforcement":"Framework for FDA emergency use authorizations","functions":["context: the earliest federal emergency determination (Feb. 4, 2020); the legal basis of every COVID-19 test EUA"],"notes":"CONTEXT ONLY. The four § 564 declarations (FED-181 to FED-184) are the framework under which the tests, respirators, ventilators, drugs and vaccines that every State and federal order presupposed were lawfully marketed.","sourceUrl":"https://www.govinfo.gov/content/pkg/FR-2020-02-07/pdf/2020-02496.pdf","snapshot":"","fileExists":true,"fileBytes":177260,"grade":"primary","character":"","description":"","collection":"FED-A","url":"/library/FED-181","exhibitUrl":"/exhibit/FED-181","citation":"Secretary of Health and Human Services, Determination of Public Health Emergency and Declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for 2019-nCoV (Feb. 4, 2020) (Ex. FED-181)","stateName":"","related":["FED-184","FED-180","FED-182","FED-183","FED-074"]}