Alex M. Azar II, Secretary of Health and Human Services, Determination of Public Health Emergency and Declaration that circumstances exist justifying emergency use of in vitro diagnostics, 85 Fed. Reg. 7316 (Feb. 7, 2020) (Feb. 4, 2020) (Ex. AGY-FED-HEALTH-OTHER-038)
Alex M. Azar II, Secretary of Health and Human Services, Declaration Under the Public Readiness and Emergency Preparedness Act for Medical Countermeasures Against COVID-19, 85 Fed. Reg. 15198 (Mar. 17, 2020) (Mar. 10, 2020) (Ex. AGY-FED-HEALTH-OTHER-040)
Centers for Disease Control and Prevention, HHS (Alex M. Azar II, Secretary), 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) (Ex. AGY-FED-HEALTH-OTHER-124)
Robert R. Redfield, M.D., Director, CDC, 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) (Ex. AGY-FED-HEALTH-OTHER-125)
Food and Drug Administration, HHS, 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) (Feb. 29, 2020) (Ex. AGY-FED-HEALTH-OTHER-032)
Alex M. Azar II, Secretary of Health and Human Services, Emergency Use Declaration (personal respiratory protective devices), 85 Fed. Reg. 13907 (Mar. 10, 2020) (Mar. 2, 2020) (Ex. AGY-FED-HEALTH-OTHER-039)
Jacqueline A. O'Shaughnessy, Acting Chief Scientist, FDA (letter to CDC), Emergency Use Authorization: NIOSH-approved air purifying respirators for health care personnel (issued Mar. 2, 2020; reissued Mar. 28, 2020 and July 12, 2021) (Ex. AGY-FED-HEALTH-OTHER-052)
Department of Veterans Affairs (Secretary Robert Wilkie), 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 centers (Ex. AGY-FED-HEALTH-OTHER-064)
Federal Bureau of Prisons (Director), after coordination with DOJ and the White House, Federal Bureau of Prisons COVID-19 Action Plan, Phase Two: agency-wide modified operations (Mar. 13, 2020) (Ex. AGY-FED-HEALTH-OTHER-072)
Thomas W. Prevoznik, Deputy Assistant Administrator, Diversion Control Division, DEA (letter to Assistant Secretary Elinore McCance-Katz, SAMHSA), 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) (Mar. 16, 2020) (Ex. AGY-FED-HEALTH-OTHER-008)
Drug Enforcement Administration, Diversion Control Division (with the HHS Secretary's designation of Mar. 16, 2020), 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) (Mar. 16, 2020) (Ex. AGY-FED-HEALTH-OTHER-009)
SAMHSA (Assistant Secretary for Mental Health and Substance Use), Opioid Treatment Program (OTP) Guidance (Mar. 16, 2020; updated Mar. 19, 2020): blanket take-home exceptions (Ex. AGY-FED-HEALTH-OTHER-026)
