| 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-009 | DEA-DC-016, COVID-19 Information Page: Telemedicine (designation that the section 802(54)(D) telemedicine allowance applies to all schedule II-V controlled substances in all areas of the United States)Use of Telemedicine While Providing Medication Assisted Treatment / COVID-19 Telemedicine (updated) | Drug Enforcement Administration, Diversion Control Division (with the HHS Secretary's designation of Mar. 16, 2020) | United States (federal); Drug Enforcement Administration, Diversion Control DivisionFederal | Mar. 16, 2020 | 2020 Q22020 Q32020 Q42021 Q12021 Q22021 Q3 | Telework mandateHealth care ordersOther | Primary source read | |
| Ex. AGY-FED-HEALTH-OTHER-001 | Notification of Enforcement Discretion for Telehealth Remote Communications During the COVID-19 Nationwide Public Health Emergency, 85 Fed. Reg. 22024 (Apr. 21, 2020)Notification of Enforcement Discretion for Telehealth Remote Communications During the COVID-19 Nationwide Public Health Emergency | Roger T. Severino, Director, Office for Civil Rights, HHS | United States (federal); Department of Health and Human Services, Office for Civil RightsFederal | Mar. 17, 2020 | 2020 Q22020 Q32020 Q42021 Q12021 Q22021 Q3 | Telework mandateHealth care ordersOther | 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-067 | VA announcement of Mar. 31, 2020: VBA closed its 56 regional offices to the public Mar. 19, 2020; benefit briefings on military installations discontinued Mar. 30, 2020; services shifted to telephone and virtual channelsVA expands virtual services to support Veterans amid regional office closures due to COVID-19 pandemic | Department of Veterans Affairs, Veterans Benefits Administration | United States (federal); Department of Veterans Affairs, Veterans Benefits AdministrationFederal | Mar. 31, 2020 | 2020 Q22020 Q32020 Q42021 Q12021 Q22021 Q3 | Context (guidance or announcement)Telework mandateCourts and public offices | 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-011 | DEA-DC-018 (DEA067), Dear Registrant letter granting an exception to separate State registration for practitioners dispensing in additional States during the COVID-19 emergencyDEA State Reciprocity (final) (Signed) | Thomas W. Prevoznik, Deputy Assistant Administrator, Diversion Control Division, DEA | United States (federal); Drug Enforcement Administration, Diversion Control DivisionFederal | Mar. 25, 2020 | 2020 Q22020 Q32020 Q42021 Q12021 Q22021 Q3 | Telework mandateHealth care ordersOther | 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-066 | VA announcement of Mar. 27, 2020 releasing the VHA COVID-19 Response Plan: elective and non-emergent procedures postponed; outpatient care shifted to telehealthVA Releases COVID-19 Response Plan | Department of Veterans Affairs | United States (federal); Department of Veterans Affairs, Veterans Health AdministrationFederal | Mar. 27, 2020 | 2020 Q2 | Context (guidance or announcement)Telework mandateHealth care orders | 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-014 | DEA-DC-022 (DEA068), letter permitting DATA-waived practitioners to prescribe buprenorphine to new patients on the basis of a telephone evaluation during the COVID-19 emergencyDEA/SAMHSA Buprenorphine Telemedicine (Final) | Thomas W. Prevoznik, Deputy Assistant Administrator, Diversion Control Division, DEA | United States (federal); Drug Enforcement Administration, Diversion Control Division (with SAMHSA)Federal | Mar. 31, 2020 | 2020 Q22020 Q32020 Q42021 Q12021 Q22021 Q3 | Telework mandateHealth care ordersOther | Primary source read | |
| Ex. AGY-FED-HEALTH-OTHER-015 | DEA-DC-023 (DEA075), How to Prescribe Controlled Substances to Patients During the COVID-19 Public Health Emergency (decision tree)How to Prescribe Controlled Substances to Patients During the COVID-19 Public Health Emergency | Drug Enforcement Administration, Diversion Control Division | United States (federal); Drug Enforcement Administration, Diversion Control DivisionFederal | Mar. 31, 2020 | 2020 Q22020 Q32020 Q42021 Q12021 Q22021 Q3 | Telework mandateHealth care ordersOther | 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 | |