| 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-039 | Emergency Use Declaration (personal respiratory protective devices), 85 Fed. Reg. 13907 (Mar. 10, 2020)Emergency Use Declaration | Alex M. Azar II, Secretary of Health and Human Services | United States (federal); Department of Health and Human Services, Office of the SecretaryFederal | Mar. 2, 2020 | 2020 Q22020 Q32020 Q42021 Q12021 Q22021 Q3 | Emergency declarationSupply 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 | |
| Ex. AGY-FED-HEALTH-OTHER-072 | Federal Bureau of Prisons COVID-19 Action Plan, Phase Two: agency-wide modified operations (Mar. 13, 2020)Federal Bureau of Prisons COVID-19 Action Plan: Agency-wide Modified Operations | Federal Bureau of Prisons (Director), after coordination with DOJ and the White House | United States (federal); Federal Bureau of PrisonsFederal | Mar. 13, 2020 | 2020 Q2 | Business closureGathering capTravel and quarantineWorkplace rules | Primary source read | |
| Ex. AGY-FED-HEALTH-OTHER-086 | Press release of Mar. 16, 2020: 'Effective March 17, 2020, Social Security Offices Will Only Offer Phone Service'Effective March 17, 2020, Social Security Offices Will Only Offer Phone Service ** Online Services Remain Available ** | Social Security Administration (Andrew Saul, Commissioner; press release by Mark Hinkle, Acting Press Officer) | United States (federal); Social Security AdministrationFederal | Mar. 16, 2020 | 2020 Q22020 Q32020 Q42021 Q12021 Q22021 Q3 | Context (guidance or announcement)Business closureTelework mandateCourts and public offices | 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-012 | DEA-DC-019 (DEA066), letter granting an exception permitting transmission of DEA Form 222 by fax or scan during the COVID-19 emergencyFax/Scan 222 (final) Esign | Thomas W. Prevoznik, Deputy Assistant Administrator, Diversion Control Division, DEA (letter to the Healthcare Distribution Alliance) | United States (federal); Drug Enforcement Administration, Diversion Control DivisionFederal | Mar. 20, 2020 | 2020 Q22020 Q32020 Q42021 Q12021 Q22021 Q3 | Supply chainOther | Primary source read | |
| 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-036 | Emergency Use Authorization Declaration (medical devices, including alternative products used as medical devices), 85 Fed. Reg. 17335 (Mar. 27, 2020)Emergency Use Authorization Declaration | Alex M. Azar II, Secretary of Health and Human Services | United States (federal); Department of Health and Human Services, Office of the SecretaryFederal | Mar. 24, 2020 | 2020 Q22020 Q32020 Q42021 Q12021 Q22021 Q3 | Emergency declarationSupply chain | 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-049 | Emergency Use Authorization: Imported, Non-NIOSH-Approved Disposable Filtering Facepiece Respirators (issued Mar. 24, 2020; reissued Mar. 28, 2020, May 7, 2020 and Mar. 24, 2021; revoked July 6, 2021)Letter of Authorization, Imported Non-NIOSH-Approved Disposable Filtering Facepiece Respirators (reissued Mar. 24, 2021) | Denise M. Hinton, Chief Scientist, FDA | United States (federal); Food and Drug AdministrationFederal | Mar. 24, 2021 | 2020 Q22020 Q32020 Q42021 Q12021 Q22021 Q3 | Health care ordersSupply chain | Primary source read | |
| Ex. AGY-FED-HEALTH-OTHER-051 | Emergency Use Authorization: Ventilators, anesthesia gas machines modified for use as ventilators, positive pressure breathing devices modified for use as ventilators, ventilator tubing connectors and ventilator accessories (Mar. 24, 2020)Letter of Authorization to Manufacturers and Other Stakeholders: Ventilators | Denise M. Hinton, Chief Scientist, FDA | United States (federal); Food and Drug AdministrationFederal | Mar. 24, 2020 | 2020 Q22020 Q32020 Q42021 Q12021 Q22021 Q3 | Health care ordersSupply 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. 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. AGY-FED-HEALTH-OTHER-037 | Emergency Use Authorization Declaration (drugs and biological products), 85 Fed. Reg. 18250 (Apr. 1, 2020)Emergency Use Authorization Declaration | Alex M. Azar II, Secretary of Health and Human Services | United States (federal); Department of Health and Human Services, Office of the SecretaryFederal | Mar. 27, 2020 | 2020 Q22020 Q32020 Q42021 Q12021 Q22021 Q3 | Emergency declarationSupply chain | Primary source read | |
| Ex. AGY-FED-HEALTH-OTHER-050 | Emergency Use Authorization: Battelle Critical Care Decontamination System for decontaminating compatible N95 respirators (issued Mar. 28, 2020; reissued Jan. 21, 2021; revoked June 30, 2021)Letter of Authorization, Battelle CCDS Critical Care Decontamination System (reissued Jan. 21, 2021) | Denise M. Hinton, Chief Scientist, FDA (letter to Battelle Memorial Institute) | United States (federal); Food and Drug AdministrationFederal | Jan. 21, 2021 | 2020 Q22020 Q32020 Q42021 Q12021 Q2 | Health care ordersSupply chain | Primary source read | |
| Ex. AGY-FED-HEALTH-OTHER-073 | COVID-19 Action Plan: Phase Five (ordered Mar. 31, 2020; effective Apr. 1, 2020): inmates secured in assigned cells/quarters for 14 days; quarantine of new admissionsCOVID-19 Action Plan: Phase Five - Additional Agency-wide Actions Effective April 1 | Director, Federal Bureau of Prisons | United States (federal); Federal Bureau of PrisonsFederal | Mar. 31, 2020 | 2020 Q2 | Business closureGathering capQuarantine and isolation | Primary source read | |
| Ex. AGY-FED-HEALTH-OTHER-053 | Emergency Use Authorization: Face Shields (umbrella) (issued Apr. 9, 2020; amended Apr. 13, 2020)Letter of Authorization, Face Shields (Apr. 13, 2020) | Denise M. Hinton, Chief Scientist, FDA | United States (federal); Food and Drug AdministrationFederal | Apr. 13, 2020 | 2020 Q22020 Q32020 Q42021 Q12021 Q22021 Q3 | Health care ordersSupply chain | Primary source read | |
| Ex. AGY-FED-HEALTH-OTHER-017 | DEA-DC-027 (DEA083), letter to DEA-registered distributors and manufacturers granting an exception to the signed-delivery requirement for narcotic shipments to narcotic treatment programsDEA Dist/MNF narcotics shipments to OTP signed delivery exception (final) | William T. McDermott, Assistant Administrator, Diversion Control Division, DEA | United States (federal); Drug Enforcement Administration, Diversion Control DivisionFederal | Apr. 10, 2020 | 2020 Q22020 Q32020 Q42021 Q12021 Q22021 Q3 | Supply chainOther | Primary source read | |
| Ex. AGY-FED-HEALTH-OTHER-019 | DEA-DC-029 (DEA085), letter granting a temporary exception to the five percent rule for practitioners distributing controlled substances to other registrants during the COVID-19 emergencyDEA 5 percent practitioner exception (final) | William T. McDermott, Assistant Administrator, Diversion Control Division, DEA | United States (federal); Drug Enforcement Administration, Diversion Control DivisionFederal | Apr. 13, 2020 | 2020 Q22020 Q32020 Q42021 Q12021 Q22021 Q3 | Health care ordersSupply chainOther | Primary source read | |
| Ex. AGY-FED-HEALTH-OTHER-033 | Notice, Guidance Documents Related to Coronavirus Disease 2019 (COVID-19); Availability, 85 Fed. Reg. 27987 (May 12, 2020)Guidance Documents Related to Coronavirus Disease 2019 (COVID-19); Availability | Food and Drug Administration, HHS | United States (federal); Food and Drug AdministrationFederal | May 12, 2020 | 2020 Q22020 Q32020 Q42021 Q12021 Q22021 Q3 | Health care ordersSupply chainOther | Primary source read | |
| Ex. AGY-FED-HEALTH-OTHER-077 | COVID-19 Action Plan: Phase Seven (ordered May 18, 2020): all Phase Six measures extended through June 30, 2020COVID-19 Action Plan: Phase Seven - Agency-wide measures extended | Director, Federal Bureau of Prisons | United States (federal); Federal Bureau of PrisonsFederal | May 20, 2020 | 2020 Q2 | Business closureGathering capTravel and quarantineQuarantine and isolation | Primary source read | |
| Ex. AGY-FED-HEALTH-OTHER-054 | Emergency Use Authorization: Gowns and Other Apparel (umbrella) (May 22, 2020)Letter of Authorization, Gowns and Other Apparel | Denise M. Hinton, Chief Scientist, FDA | United States (federal); Food and Drug AdministrationFederal | May 22, 2020 | 2020 Q22020 Q32020 Q42021 Q12021 Q22021 Q3 | Health care ordersSupply chain | Primary source read | |
| Ex. AGY-FED-HEALTH-OTHER-034 | Notice, Authorization of Emergency Use of Certain Medical Devices During COVID-19; Availability, 85 Fed. Reg. 34638 (June 5, 2020)Authorization of Emergency Use of Certain Medical Devices During COVID-19; Availability | Food and Drug Administration, HHS | United States (federal); Food and Drug AdministrationFederal | June 5, 2020 | 2020 Q22020 Q32020 Q42021 Q12021 Q22021 Q3 | Health care ordersSupply chain | Primary source read | |
| Ex. AGY-FED-HEALTH-OTHER-055 | Emergency Use Authorization: Surgical Masks (umbrella) (issued Aug. 5, 2020; reissued Mar. 6, 2023)Letter of Authorization, Surgical Masks (reissued Mar. 6, 2023) | Food and Drug Administration (Office of the Chief Scientist) | United States (federal); Food and Drug AdministrationFederal | Mar. 6, 2023 | 2020 Q32020 Q42021 Q12021 Q22021 Q3 | Health care ordersSupply chain | Primary source read | |