| Ex. AGY-FED-HEALTH-OTHER-043 | Guidance for Industry and FDA Staff: Enforcement Policy for Ventilators and Accessories and Other Respiratory Devices During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency (March 2020)Enforcement Policy for Ventilators and Accessories and Other Respiratory Devices During the Coronavirus Disease 2019 (COVID-19) Public… | Food and Drug Administration, CDRH | United States (federal); Food and Drug Administration, Center for Devices and Radiological HealthFederal | Mar. 22, 2020 | 2020 Q22020 Q32020 Q42021 Q12021 Q22021 Q3 | Context (guidance or announcement)Health care ordersSupply chainOther | Primary source read | |
| Ex. AGY-FED-HEALTH-OTHER-038 | Determination of Public Health Emergency and Declaration that circumstances exist justifying emergency use of in vitro diagnostics, 85 Fed. Reg. 7316 (Feb. 7, 2020)Determination of Public Health Emergency | Alex M. Azar II, Secretary of Health and Human Services | United States (federal); Department of Health and Human Services, Office of the SecretaryFederal | Feb. 4, 2020 | 2020 Q22020 Q32020 Q42021 Q12021 Q22021 Q3 | Emergency declarationSupply chain | Primary source read | |
| Ex. AGY-FED-HEALTH-OTHER-044 | Guidance: Enforcement Policy for Face Masks and Respirators During the Coronavirus Disease (COVID-19) Public Health Emergency (Mar. 25, 2020; revised Apr. 2020, May 2020, Sept. 2021; superseded Sept. 5, 2023)Enforcement Policy for Face Masks and Respirators During the Coronavirus Disease (COVID-19) Public Health Emergency | Food and Drug Administration, CDRH | United States (federal); Food and Drug Administration, Center for Devices and Radiological HealthFederal | Mar. 25, 2020 | 2020 Q22020 Q32020 Q42021 Q12021 Q22021 Q3 | Context (guidance or announcement)Face-covering requirementSupply chainOther | Confirmed from a secondary source | |
| Ex. FED-010 | Determination that a Public Health Emergency Exists Nationwide as the Result of the 2019 Novel CoronavirusDetermination that a Public Health Emergency Exists | Alex M. Azar II, Secretary of Health and Human Services | United StatesFederal | Jan. 31, 2020 | 2020 Q22020 Q32020 Q42021 Q12021 Q22021 Q3 | Emergency declaration | Primary source read | |
| Ex. AGY-FED-HEALTH-OTHER-041 | Guidance for Industry: Temporary Policy for Preparation of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (COVID-19) (Mar. 19, 2020; updated Mar. 27 and Apr. 15, 2020, and later)Temporary Policy for Preparation of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (COVID-19) | Food and Drug Administration, CDER | United States (federal); Food and Drug Administration, Center for Drug Evaluation and ResearchFederal | Mar. 19, 2020 | 2020 Q22020 Q32020 Q42021 Q12021 Q22021 Q3 | Context (guidance or announcement)Supply chainOther | Primary source read | |
| Ex. AGY-FED-HEALTH-OTHER-042 | Guidance for Industry: Temporary Policy for Manufacture of Alcohol for Incorporation Into Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (COVID-19) (Mar. 24, 2020; updated Mar. 27 and Apr. 15, 2020, and later)Temporary Policy for Manufacture of Alcohol for Incorporation Into Alcohol-Based Hand Sanitizer Products During the Public Health Emergency… | Food and Drug Administration, CDER | United States (federal); Food and Drug Administration, Center for Drug Evaluation and ResearchFederal | Mar. 24, 2020 | 2020 Q22020 Q32020 Q42021 Q12021 Q22021 Q3 | Context (guidance or announcement)Supply chainOther | Primary source read | |
| Ex. AGY-FED-HEALTH-OTHER-058 | IHS Coronavirus (COVID-19) News page listing the Tribal and Urban Indian Organization Leader letters of Mar. 9, 16, 23 and 27, 2020 (archived Mar. 29, 2020)Coronavirus (COVID-19) / News: Tribal and Urban Indian Organization Leader Messages on COVID-19 | Indian Health Service (Principal Deputy Director Rear Adm. Michael D. Weahkee) | United States (federal); Department of Health and Human Services, Indian Health ServiceFederal | Mar. 29, 2020 | 2020 Q2 | Emergency declarationHealth care orders | Confirmed from a secondary source | |
| Ex. FED-181 | Determination of Public Health Emergency and Declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for 2019-nCoVDetermination of Public Health Emergency, 85 Fed. Reg. 7316 (Feb. 7, 2020) | Secretary of Health and Human Services | United StatesFederal | Feb. 4, 2020 | 2020 Q22020 Q32020 Q42021 Q12021 Q22021 Q3 | Emergency declarationHealth care orders | Primary source read | |
| Ex. AGY-FED-HEALTH-OTHER-045 | Guidance for Industry: Temporary Policy Regarding Nutrition Labeling of Certain Packaged Food During the COVID-19 Public Health Emergency (Mar. 26, 2020)Temporary Policy Regarding Nutrition Labeling of Certain Packaged Food During the COVID-19 Public Health Emergency | Food and Drug Administration, CFSAN | United States (federal); Food and Drug Administration, Center for Food Safety and Applied NutritionFederal | Mar. 26, 2020 | 2020 Q22020 Q32020 Q42021 Q12021 Q22021 Q3 | Context (guidance or announcement)Supply chainOther | Primary source read | |
| Ex. FED-016 | Renewal of Determination that a Public Health Emergency Exists (July 19, 2021)Renewal of Determination that a Public Health Emergency Exists | Xavier Becerra, Secretary of HHS | United StatesFederal | July 19, 2021 | 2021 Q3 | Emergency declaration | Primary source read | |
| Ex. SEC-10-001 | Executive Order 13909, Prioritizing and Allocating Health and Medical Resources to Respond to the Spread of COVID-19Prioritizing and Allocating Health and Medical Resources to Respond to the Spread of COVID-19, 85 Fed. Reg. 16227 (Mar. 23, 2020) | President (Executive Order 13909) | United StatesFederal | Mar. 18, 2020 | 2020 Q22020 Q32020 Q42021 Q12021 Q22021 Q3 | Supply chain | Primary source read | |
| Ex. FED-015 | Renewal of Determination that a Public Health Emergency Exists (April 15, 2021)Renewal of Determination that a Public Health Emergency Exists | Xavier Becerra, Secretary of HHS | United StatesFederal | Apr. 15, 2021 | 2021 Q22021 Q3 | Emergency declaration | Primary source read | |
| Ex. AGY-DEFENSE-GUARD-026 | Force Health Protection Guidance for the Novel Coronavirus Outbreak (Jan. 30, 2020)Force Health Protection Guidance for the Novel Coronavirus Outbreak | Under Secretary of Defense for Personnel and Readiness (Matthew P. Donovan) | Department of Defense (department-wide)Federal | Jan. 30, 2020 | 2020 Q22020 Q32020 Q42021 Q12021 Q22021 Q3 | Emergency declarationHealth care ordersQuarantine and isolation | Primary source read | |
| Ex. ECO-A-064 | Temporary Final Rule, Prioritization and Allocation of Certain Scarce or Threatened Health and Medical Resources for Domestic Use, 44 C.F.R. part 328, 85 Fed. Reg. 20195 (Apr. 10, 2020)Prioritization and Allocation of Certain Scarce or Threatened Health and Medical Resources for Domestic Use | Federal Emergency Management Agency, Department of Homeland Security (Administrator Peter T. Gaynor) | United StatesFederal | Apr. 7, 2020 | 2020 Q22020 Q3 | Supply chain | Primary source read | |
| Ex. FED-011 | Renewal of Determination that a Public Health Emergency Exists (April 21, 2020)Renewal of Determination that a Public Health Emergency Exists | Alex M. Azar II, Secretary of HHS | United StatesFederal | Apr. 21, 2020 | 2020 Q22020 Q3 | Emergency declaration | Primary source read | |
| Ex. FED-012 | Renewal of Determination that a Public Health Emergency Exists (July 23, 2020)Renewal of Determination that a Public Health Emergency Exists | Alex M. Azar II, Secretary of HHS | United StatesFederal | July 23, 2020 | 2020 Q32020 Q4 | Emergency declaration | Primary source read | |
| Ex. FED-013 | Renewal of Determination that a Public Health Emergency Exists (October 2, 2020)Renewal of Determination that a Public Health Emergency Exists | Alex M. Azar II, Secretary of HHS | United StatesFederal | Oct. 2, 2020 | 2020 Q42021 Q1 | Emergency declaration | Primary source read | |
| Ex. FED-014 | Renewal of Determination that a Public Health Emergency Exists (January 7, 2021)Renewal of Determination that a Public Health Emergency Exists | Alex M. Azar II, Secretary of HHS | United StatesFederal | Jan. 7, 2021 | 2021 Q12021 Q2 | Emergency declaration | Primary source read | |
| Ex. FED-017 | Renewal of Determination that a Public Health Emergency Exists (October 15, 2021)Renewal of Determination that a Public Health Emergency Exists | Xavier Becerra, Secretary of HHS | United StatesFederal | Oct. 15, 2021 | | Emergency declaration | Primary source read | |
| Ex. FED-070 | Executive Order 13909Prioritizing and Allocating Health and Medical Resources to Respond to the Spread of COVID-19, 85 Fed. Reg. 16227 (Mar. 23, 2020) | President Donald J. Trump | United States (all health and medical resources needed to respond to COVID-19)Federal | Mar. 18, 2020 | 2020 Q22020 Q32020 Q42021 Q12021 Q22021 Q3 | Supply chain | Primary source read | |
| Ex. FED-075 | Temporary Final Rule, Prioritization and Allocation of Certain Scarce or Threatened Health and Medical Resources for Domestic UsePrioritization and Allocation of Certain Scarce or Threatened Health and Medical Resources for Domestic Use, 85 Fed. Reg. 20195 (Apr. 10… | Federal Emergency Management Agency, DHS | United States (all exports of covered PPE)Federal | Apr. 7, 2020 | 2020 Q22020 Q3 | Travel and quarantineSupply chain | Primary source read | |
| Ex. SEC-01-011 | Renewal of Determination that a Public Health Emergency Exists (July 19, 2021, effective July 20, 2021)Renewal of Determination That A Public Health Emergency Exists | Secretary of HHS | United StatesFederal | July 19, 2021 | 2021 Q3 | Emergency declaration | Confirmed from a secondary source | |
| Ex. SEC-01-013 | Temporary Final Rule, Prioritization and Allocation of Certain Scarce or Threatened Health and Medical Resources for Domestic Use, 44 C.F.R. part 328, 85 Fed. Reg. 20195Prioritization and Allocation of Certain Scarce or Threatened Health and Medical Resources for Domestic Use | FEMA, Department of Homeland Security | United StatesFederal | Apr. 10, 2020 | 2020 Q22020 Q32020 Q42021 Q12021 Q2 | Supply chain | Primary source read | |
| Ex. SEC-10-013 | Memorandum on Allocating Certain Scarce or Threatened Health and Medical Resources to Domestic UseMemorandum on Allocating Certain Scarce or Threatened Health and Medical Resources to Domestic Use | President (Memorandum for the Secretaries of HHS and Homeland Security) | United StatesFederal | Apr. 3, 2020 | 2020 Q22020 Q32020 Q42021 Q12021 Q2 | Travel and quarantineSupply chain | Primary source read | |
| Ex. AGY-FED-HEALTH-OTHER-052 | Emergency Use Authorization: NIOSH-approved air purifying respirators for health care personnel (issued Mar. 2, 2020; reissued Mar. 28, 2020 and July 12, 2021)Letter of Authorization to CDC, NIOSH-Approved Air Purifying Respirators (reissued July 12, 2021) | Jacqueline A. O'Shaughnessy, Acting Chief Scientist, FDA (letter to CDC) | United States (federal); Food and Drug AdministrationFederal | July 12, 2021 | 2020 Q22020 Q32020 Q42021 Q12021 Q22021 Q3 | Health care ordersSupply chain | Primary source read | |