{"id":"AGY-FED-HEALTH-OTHER-037","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":"Emergency Use Authorization Declaration (drugs and biological products), 85 Fed. Reg. 18250 (Apr. 1, 2020)","title":"Emergency Use Authorization Declaration","dateIssued":"2020-03-27","effective":"2020-03-27 (determination effective Feb. 4, 2020)","end":"In force throughout 2020-2021","startDate":"2020-03-27","endDate":"2021-09-30","quarters":["2020Q2","2020Q3","2020Q4","2021Q1","2021Q2","2021Q3"],"types":["SUPPLY","EMER"],"addressees":["FDA; drug and biologic manufacturers"],"clause":"he also declared that circumstances exist justifying the authorization of emergency use of drugs and biological products during the COVID-19 pandemic, pursuant to section 564 of the FD\u0026C Act, subject to the terms of any authorization issued under that section.... DATES: The determination was effective February 4, 2020, and this declaration is effective March 27, 2020.","enforcement":"Predicate for FDA drug and vaccine EUAs","functions":["SC supply chain","IC infection control (therapeutics, vaccines)"],"notes":"Predicate for every COVID-19 vaccine and therapeutic EUA of 2020-2021, and therefore for the vaccination mandates of Q3 2021.","sourceUrl":"https://www.govinfo.gov/content/pkg/FR-2020-04-01/pdf/2020-06905.pdf","snapshot":"","fileExists":true,"fileBytes":178407,"grade":"primary","character":"","description":"","collection":"AGY-FED-HEALTH-OTHER","url":"/library/AGY-FED-HEALTH-OTHER-037","exhibitUrl":"/exhibit/AGY-FED-HEALTH-OTHER-037","citation":"Alex M. Azar II, Secretary of Health and Human Services, Emergency Use Authorization Declaration (drugs and biological products), 85 Fed. Reg. 18250 (Apr. 1, 2020) (Mar. 27, 2020) (Ex. AGY-FED-HEALTH-OTHER-037)","stateName":"","related":["AGY-FED-HEALTH-OTHER-036","AGY-FED-HEALTH-OTHER-039","AGY-FED-HEALTH-OTHER-038","AGY-FED-HEALTH-OTHER-040"]}