| Ex. AGY-FED-HEALTH-OTHER-040 | Declaration Under the Public Readiness and Emergency Preparedness Act for Medical Countermeasures Against COVID-19, 85 Fed. Reg. 15198 (Mar. 17, 2020)Declaration Under the Public Readiness and Emergency Preparedness Act for Medical Countermeasures Against COVID-19 | Alex M. Azar II, Secretary of Health and Human Services | United States (federal); Department of Health and Human Services, Office of the SecretaryFederal | Mar. 10, 2020 | 2020 Q22020 Q32020 Q42021 Q12021 Q22021 Q3 | Emergency declarationHealth care ordersOther | Primary source read | |
| Ex. AGY-FED-HEALTH-OTHER-032 | Policy for Diagnostics Testing in Laboratories Certified To Perform High Complexity Testing Under CLIA Prior to Emergency Use Authorization for Coronavirus Disease-2019 During the Public Health Emergency; Immediately in Effect Guidance, 85 Fed. Reg. 13138 (Mar. 6, 2020)Policy for Diagnostics Testing in Laboratories Certified To Perform High Complexity Testing Under the Clinical Laboratory Improvement… | Food and Drug Administration, HHS | United States (federal); Food and Drug AdministrationFederal | Feb. 29, 2020 | 2020 Q22020 Q32020 Q42021 Q12021 Q22021 Q3 | Health care ordersOther | 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-064 | VA announcement of Mar. 10, 2020: 'No Visitor' stance and suspension of new admissions at all VA nursing homes (community living centers) and spinal cord injury and disorder centersVA announces safeguards to protect nursing home and spinal cord injury patients | Department of Veterans Affairs (Secretary Robert Wilkie) | United States (federal); Department of Veterans Affairs, Veterans Health AdministrationFederal | Mar. 10, 2020 | 2020 Q22020 Q3 | Context (guidance or announcement)Gathering capHealth care orders | Primary source read | |
| Ex. AGY-FED-HEALTH-OTHER-008 | DEA-DC-015, Exception to 21 C.F.R. 1301.74(h) for Narcotic Treatment Programs (take-home delivery by NTP staff, law enforcement or National Guard)SAMHSA Exemption - NTP Deliveries (Coronavirus) | Thomas W. Prevoznik, Deputy Assistant Administrator, Diversion Control Division, DEA (letter to Assistant Secretary Elinore McCance-Katz, SAMHSA) | United States (federal); Drug Enforcement Administration, Diversion Control DivisionFederal | Mar. 16, 2020 | 2020 Q22020 Q32020 Q42021 Q12021 Q22021 Q3 | Health care ordersOther | 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-026 | Opioid Treatment Program (OTP) Guidance (Mar. 16, 2020; updated Mar. 19, 2020): blanket take-home exceptionsOpioid Treatment Program (OTP) Guidance | SAMHSA (Assistant Secretary for Mental Health and Substance Use) | United States (federal); Substance Abuse and Mental Health Services AdministrationFederal | Mar. 16, 2020 | 2020 Q22020 Q32020 Q42021 Q12021 Q22021 Q3 | Health 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-027 | COVID-19 Public Health Emergency Response and 42 CFR Part 2 GuidanceCOVID-19 Public Health Emergency Response and 42 CFR Part 2 Guidance | SAMHSA | United States (federal); Substance Abuse and Mental Health Services AdministrationFederal | Mar. 19, 2020 | 2020 Q22020 Q32020 Q42021 Q12021 Q22021 Q3 | Context (guidance or announcement)Health care ordersOther | Primary source read | |
| Ex. AGY-FED-HEALTH-OTHER-010 | DEA-DC-017 (DEA065), Dear Registrant letter on early refills and 90-day supplies of controlled substances during the COVID-19 emergencyEarly RX Refill (OMB 3-20-20) | Thomas W. Prevoznik, Deputy Assistant Administrator, Diversion Control Division, DEA | United States (federal); Drug Enforcement Administration, Diversion Control DivisionFederal | Mar. 20, 2020 | 2020 Q22020 Q32020 Q42021 Q12021 Q22021 Q3 | Health care ordersOther | 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-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-013 | DEA-DC-021 (DEA073), letter to practitioner registrants and pharmacists announcing temporary exceptions for oral schedule II prescriptions in emergency situations during the COVID-19 emergencyOral CII for regular CII script (Final) | Drug Enforcement Administration, Diversion Control Division | United States (federal); Drug Enforcement Administration, Diversion Control DivisionFederal | Mar. 27, 2020 | 2020 Q22020 Q32020 Q42021 Q12021 Q22021 Q3 | Health care ordersOther | 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-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. AGY-FED-HEALTH-OTHER-028 | OTP Guidance for Patients Quarantined at Home with the Coronavirus (doorstep delivery protocol) (updated Mar. 30, 2020)OTP Guidance for Patients Quarantined at Home with the Coronavirus | SAMHSA, Division of Pharmacologic Therapies, Center for Substance Abuse Treatment | United States (federal); Substance Abuse and Mental Health Services AdministrationFederal | Mar. 30, 2020 | 2020 Q22020 Q32020 Q42021 Q12021 Q22021 Q3 | Context (guidance or announcement)Health care ordersQuarantine and isolationOther | 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-002 | Enforcement Discretion Under HIPAA To Allow Uses and Disclosures of Protected Health Information by Business Associates for Public Health and Health Oversight Activities in Response to COVID-19, 85 Fed. Reg. 19392 (Apr. 7, 2020)Enforcement Discretion Under HIPAA To Allow Uses and Disclosures of Protected Health Information by Business Associates for Public Health… | Roger T. Severino, Director, Office for Civil Rights, HHS | United States (federal); Department of Health and Human Services, Office for Civil RightsFederal | Apr. 2, 2020 | 2020 Q22020 Q32020 Q42021 Q12021 Q22021 Q3 | Health care ordersOther | Primary source read | |
| Ex. AGY-FED-HEALTH-OTHER-016 | DEA-DC-025 (DEA078), Dear Registrant letter permitting opioid treatment programs to use the same off-site location repeatedly to deliver take-home methadone doses without separate registrationOff-site OTP delivery method (Final) | Thomas W. Prevoznik, Deputy Assistant Administrator, Diversion Control Division, DEA | United States (federal); Drug Enforcement Administration, Diversion Control DivisionFederal | Apr. 7, 2020 | 2020 Q22020 Q32020 Q42021 Q12021 Q22021 Q3 | Health care ordersOther | Primary source read | |
| Ex. AGY-FED-HEALTH-OTHER-003 | Enforcement Discretion Regarding COVID-19 Community-Based Testing Sites (CBTS) During the COVID-19 Nationwide Public Health Emergency, 85 Fed. Reg. 29637 (May 18, 2020)Enforcement Discretion Regarding COVID-19 Community-Based Testing Sites (CBTS) 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 | Apr. 9, 2020 | 2020 Q22020 Q32020 Q42021 Q12021 Q22021 Q3 | Health 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 | |