{"id":"AGY-FED-HEALTH-OTHER-038","kind":"order","level":"federal","jurisdiction":"United States (federal); Department of Health and Human Services, Office of the Secretary","state":"","metro":"","industry":"","agency":"FED-HEALTH-OTHER","eco":"","issuer":"Alex M. Azar II, Secretary of Health and Human Services","authority":"FD\u0026C Act s. 564(b)(1)(C)","instrument":"Determination of Public Health Emergency and Declaration that circumstances exist justifying emergency use of in vitro diagnostics, 85 Fed. Reg. 7316 (Feb. 7, 2020)","title":"Determination of Public Health Emergency","dateIssued":"2020-02-04","effective":"2020-02-04","end":"In force throughout 2020-2021","startDate":"2020-02-04","endDate":"2021-09-30","quarters":["2020Q2","2020Q3","2020Q4","2021Q1","2021Q2","2021Q3"],"types":["EMER","SUPPLY"],"addressees":["FDA; test developers and laboratories"],"clause":"I declared that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection and/or diagnosis of the novel coronavirus (2019-nCoV) pursuant to section 564 of the FD\u0026C Act, subject to the terms of any authorization issued under that section.... DATES: The determination and declaration took effect February 4, 2020.","enforcement":"Predicate for test EUAs","functions":["DX diagnostics","SC supply chain"],"notes":"The first federal COVID-19 emergency instrument after the section 319 declaration.","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":"AGY-FED-HEALTH-OTHER","url":"/library/AGY-FED-HEALTH-OTHER-038","exhibitUrl":"/exhibit/AGY-FED-HEALTH-OTHER-038","citation":"Alex M. Azar II, Secretary of Health and Human Services, Determination of Public Health Emergency and Declaration that circumstances exist justifying emergency use of in vitro diagnostics, 85 Fed. Reg. 7316 (Feb. 7, 2020) (Feb. 4, 2020) (Ex. AGY-FED-HEALTH-OTHER-038)","stateName":"","related":["AGY-FED-HEALTH-OTHER-040","AGY-FED-HEALTH-OTHER-039","AGY-FED-HEALTH-OTHER-036","AGY-FED-HEALTH-OTHER-037"]}