| 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-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-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-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-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. 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-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-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-046 | Guidance for Industry: Temporary Policy Regarding Nutrition Labeling of Standard Menu Items in Chain Restaurants and Similar Retail Food Establishments During the COVID-19 Public Health Emergency (Apr. 2020)Temporary Policy Regarding Nutrition Labeling of Standard Menu Items in Chain Restaurants and Similar Retail Food Establishments During the… | Food and Drug Administration, CFSAN | United States (federal); Food and Drug Administration, Center for Food Safety and Applied NutritionFederal | Apr. 1, 2020 | 2020 Q22020 Q32020 Q42021 Q12021 Q22021 Q3 | Context (guidance or announcement)Other | 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-118 | Provider Relief Fund, Acceptance of Terms and Conditions, Relief Fund Payment from Initial $30 Billion General DistributionAcceptance of Terms and Conditions - Relief Fund Payment from Initial $30 Billion General Distribution | Secretary of Health and Human Services (terms administered by HRSA) | United States (federal); Department of Health and Human Services (Health Resources and Services Administration administering the Provider Relief Fund)Federal | Apr. 10, 2020 | 2020 Q22020 Q32020 Q42021 Q12021 Q22021 Q3 | Health care ordersOther | 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. 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-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-025 | FAQs: Provision of methadone and buprenorphine for the treatment of Opioid Use Disorder in the COVID-19 emergencyFAQs: Provision of methadone and buprenorphine for the treatment of Opioid Use Disorder in the COVID-19 emergency | SAMHSA, Center for Substance Abuse Treatment, Division of Pharmacologic Therapies | United States (federal); Department of Health and Human Services, Substance Abuse and Mental Health Services AdministrationFederal | Apr. 21, 2020 | 2020 Q22020 Q32020 Q42021 Q12021 Q22021 Q3 | Context (guidance or announcement)Health 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-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-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-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-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-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-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 | |