{"id":"AGY-FED-HEALTH-OTHER-039","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 Declaration (personal respiratory protective devices), 85 Fed. Reg. 13907 (Mar. 10, 2020)","title":"Emergency Use Declaration","dateIssued":"2020-03-02","effective":"2020-03-02","end":"In force throughout 2020-2021","startDate":"2020-03-02","endDate":"2021-09-30","quarters":["2020Q2","2020Q3","2020Q4","2021Q1","2021Q2","2021Q3"],"types":["SUPPLY","EMER"],"addressees":["FDA; respirator manufacturers, importers and users"],"clause":"he also declared that circumstances exist justifying the authorization of emergency use of personal respiratory protective devices during the COVID-19 outbreak, 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 2, 2020.","enforcement":"Predicate for the respirator EUAs","functions":["SC supply chain (N95 respirators)","IC infection control"],"notes":"","sourceUrl":"https://www.govinfo.gov/content/pkg/FR-2020-03-10/pdf/2020-04823.pdf","snapshot":"","fileExists":true,"fileBytes":199488,"grade":"primary","character":"","description":"","collection":"AGY-FED-HEALTH-OTHER","url":"/library/AGY-FED-HEALTH-OTHER-039","exhibitUrl":"/exhibit/AGY-FED-HEALTH-OTHER-039","citation":"Alex M. Azar II, Secretary of Health and Human Services, Emergency Use Declaration (personal respiratory protective devices), 85 Fed. Reg. 13907 (Mar. 10, 2020) (Mar. 2, 2020) (Ex. AGY-FED-HEALTH-OTHER-039)","stateName":"","related":["AGY-FED-HEALTH-OTHER-036","AGY-FED-HEALTH-OTHER-037","AGY-FED-HEALTH-OTHER-038","AGY-FED-HEALTH-OTHER-040"]}