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)
Roger T. Severino, Director, Office for Civil Rights, HHS, Notification of Enforcement Discretion for Telehealth Remote Communications During the COVID-19 Nationwide Public Health Emergency, 85 Fed. Reg. 22024 (Apr. 21, 2020) (Mar. 17, 2020) (Ex. AGY-FED-HEALTH-OTHER-001)
Social Security Administration (Andrew Saul, Commissioner; press release by Mark Hinkle, Acting Press Officer), Press release of Mar. 16, 2020: 'Effective March 17, 2020, Social Security Offices Will Only Offer Phone Service' (Ex. AGY-FED-HEALTH-OTHER-086)
SAMHSA, COVID-19 Public Health Emergency Response and 42 CFR Part 2 Guidance (Mar. 19, 2020) (Ex. AGY-FED-HEALTH-OTHER-027)
Food and Drug Administration, CDER, 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) (Ex. AGY-FED-HEALTH-OTHER-041)
Department of Veterans Affairs, Veterans Benefits Administration, 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 channels (Ex. AGY-FED-HEALTH-OTHER-067)
Federal Bureau of Prisons, Updates to BOP COVID-19 Action Plan: Inmate Movement (Mar. 19, 2020) (Ex. AGY-FED-HEALTH-OTHER-074)
Thomas W. Prevoznik, Deputy Assistant Administrator, Diversion Control Division, DEA, DEA-DC-017 (DEA065), Dear Registrant letter on early refills and 90-day supplies of controlled substances during the COVID-19 emergency (Mar. 20, 2020) (Ex. AGY-FED-HEALTH-OTHER-010)
Thomas W. Prevoznik, Deputy Assistant Administrator, Diversion Control Division, DEA (letter to the Healthcare Distribution Alliance), DEA-DC-019 (DEA066), letter granting an exception permitting transmission of DEA Form 222 by fax or scan during the COVID-19 emergency (Mar. 20, 2020) (Ex. AGY-FED-HEALTH-OTHER-012)
Food and Drug Administration, CDRH, 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) (Mar. 22, 2020) (Ex. AGY-FED-HEALTH-OTHER-043)
Department of Veterans Affairs, National Cemetery Administration, VA announcement of Mar. 20, 2020: committal services and military funeral honors discontinued at all national cemeteries effective Mar. 23, 2020; witnesses limited to immediate family of no more than ten (Ex. AGY-FED-HEALTH-OTHER-065)
Alex M. Azar II, Secretary of Health and Human Services, Emergency Use Authorization Declaration (medical devices, including alternative products used as medical devices), 85 Fed. Reg. 17335 (Mar. 27, 2020) (Mar. 24, 2020) (Ex. AGY-FED-HEALTH-OTHER-036)
Food and Drug Administration, CDER, 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) (Ex. AGY-FED-HEALTH-OTHER-042)
Denise M. Hinton, Chief Scientist, FDA, 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) (Ex. AGY-FED-HEALTH-OTHER-049)
Denise M. Hinton, Chief Scientist, FDA, 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) (Ex. AGY-FED-HEALTH-OTHER-051)
