| 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-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-124 | Interim Final Rule, Control of Communicable Diseases; Foreign Quarantine (requirements for airlines to collect and transmit designated passenger and crew information), 85 Fed. Reg. 7874 (Feb. 12, 2020)Control of Communicable Diseases; Foreign Quarantine | Centers for Disease Control and Prevention, HHS (Alex M. Azar II, Secretary) | United States (federal); Centers for Disease Control and Prevention, HHSFederal | Feb. 12, 2020 | 2020 Q22020 Q32020 Q42021 Q12021 Q22021 Q3 | Travel and quarantineWorkplace rules | Primary source read | |
| Ex. AGY-FED-HEALTH-OTHER-125 | Agency Order, Collection of Certain Data Regarding Passengers and Crew Arriving From Foreign Countries by Airlines (issued Feb. 18, 2020), 85 Fed. Reg. 10439 (Feb. 24, 2020)Collection of Certain Data Regarding Passengers and Crew Arriving From Foreign Countries by Airlines | Robert R. Redfield, M.D., Director, CDC | United States (federal); Centers for Disease Control and Prevention, HHSFederal | Feb. 18, 2020 | 2020 Q22020 Q32020 Q42021 Q12021 Q22021 Q3 | Travel and quarantineWorkplace rules | 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-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-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-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-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-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-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-131 | Notice, Process for Making Available Guidance Documents Related to Coronavirus Disease 2019, 85 Fed. Reg. 16949 (Mar. 25, 2020)Process for Making Available Guidance Documents Related to Coronavirus Disease 2019 | Food and Drug Administration, HHS | United States (federal); Food and Drug AdministrationFederal | Mar. 25, 2020 | 2020 Q22020 Q32020 Q42021 Q12021 Q22021 Q3 | Other | Primary source read | |
| Ex. AGY-FED-HEALTH-OTHER-081 | Memorandum for Director of Bureau of Prisons, Prioritization of Home Confinement As Appropriate in Response to COVID-19 Pandemic (Mar. 26, 2020)Prioritization of Home Confinement As Appropriate in Response to COVID-19 Pandemic | William P. Barr, Attorney General | United States (federal); Department of Justice, Office of the Attorney GeneralFederal | Mar. 26, 2020 | 2020 Q22020 Q32020 Q42021 Q12021 Q22021 Q3 | Other | 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-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-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 | |