{"id":"AGY-FED-HEALTH-OTHER-033","kind":"order","level":"federal","jurisdiction":"United States (federal); Food and Drug Administration","state":"","metro":"","industry":"","agency":"FED-HEALTH-OTHER","eco":"","issuer":"Food and Drug Administration, HHS","authority":"FD\u0026C Act s. 701(h); 21 C.F.R. 10.115(g)(2)","instrument":"Notice, Guidance Documents Related to Coronavirus Disease 2019 (COVID-19); Availability, 85 Fed. Reg. 27987 (May 12, 2020)","title":"Guidance Documents Related to Coronavirus Disease 2019 (COVID-19); Availability","dateIssued":"2020-05-12","effective":"Lists guidances issued Mar. 19-Apr. 2020, each immediately in effect","end":"Each guidance in effect for the duration of the public health emergency (hand-sanitizer policies withdrawn Dec. 31, 2021; menu labeling to Nov. 7, 2023)","startDate":"2020-05-12","endDate":"2021-12-31","quarters":["2020Q2","2020Q3","2020Q4","2021Q1","2021Q2","2021Q3"],"types":["SUPPLY","HC","OTHER"],"addressees":["manufacturers, distillers, restaurants, food manufacturers, device manufacturers"],"clause":"The Food and Drug Administration (FDA or Agency) is announcing the availability of FDA guidance documents related to the Coronavirus Disease 2019 (COVID-19) public health emergency (PHE).... Enforcement Policy for Ventilators and Accessories and Other Respiratory Devices During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency (March 2020).... Temporary Policy Regarding Nutrition Labeling of Certain Packaged Food During the COVID-19 Public Health Emergency (March 2020). Temporary Policy Regarding Nutrition Labeling of Standard Menu Items in Chain Restaurants and Similar Retail Food Establishments During the COVID-19 Public Health Emergency (April 2020). Temporary Policy for Preparation of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (COVID-19) (March 19, 2020) (Updated March 27, 2020, and April 15, 2020).","enforcement":"Statement of FDA enforcement posture under 21 U.S.C. 331 for each listed policy","functions":["SC supply chain","PF production floor (converted lines)","KT kitchen and food supply","DR dining room (menu labeling)"],"notes":"Official Federal Register record of the titles and dates of the FDA COVID-19 policies, including the ventilator and shell-egg policies whose texts FDA has since removed from its site.","sourceUrl":"https://www.govinfo.gov/content/pkg/FR-2020-05-12/pdf/2020-10146.pdf","snapshot":"","fileExists":true,"fileBytes":246630,"grade":"primary","character":"","description":"","collection":"AGY-FED-HEALTH-OTHER","url":"/library/AGY-FED-HEALTH-OTHER-033","exhibitUrl":"/exhibit/AGY-FED-HEALTH-OTHER-033","citation":"Food and Drug Administration, HHS, Notice, Guidance Documents Related to Coronavirus Disease 2019 (COVID-19); Availability, 85 Fed. Reg. 27987 (May 12, 2020) (Ex. AGY-FED-HEALTH-OTHER-033)","stateName":"","related":["AGY-FED-HEALTH-OTHER-035","AGY-FED-HEALTH-OTHER-034","AGY-FED-HEALTH-OTHER-131","AGY-FED-HEALTH-OTHER-032"]}