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)
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)
Food and Drug Administration, CDRH, 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the Coronavirus Disease (COVID-19) Public Health Emergency (Mar. 25, 2020; revised Apr. 2020, May 2020, Sept. 2021; superseded Sept. 5, 2023) (Ex. AGY-FED-HEALTH-OTHER-044)
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)
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)
Food and Drug Administration, CFSAN, Guidance for Industry: Temporary Policy Regarding Nutrition Labeling of Certain Packaged Food During the COVID-19 Public Health Emergency (Mar. 26, 2020) (Ex. AGY-FED-HEALTH-OTHER-045)
President (Executive Order 13909), Executive Order 13909, Prioritizing and Allocating Health and Medical Resources to Respond to the Spread of COVID-19 (Mar. 18, 2020) (Ex. SEC-10-001)
Federal Emergency Management Agency, Department of Homeland Security (Administrator Peter T. Gaynor), Temporary Final Rule, Prioritization and Allocation of Certain Scarce or Threatened Health and Medical Resources for Domestic Use, 44 C.F.R. part 328, 85 Fed. Reg. 20195 (Apr. 10, 2020) (Apr. 7, 2020) (Ex. ECO-A-064)
President Donald J. Trump, Executive Order 13909 (Mar. 18, 2020) (Ex. FED-070)
Federal Emergency Management Agency, DHS, Temporary Final Rule, Prioritization and Allocation of Certain Scarce or Threatened Health and Medical Resources for Domestic Use (Apr. 7, 2020) (Ex. FED-075)
FEMA, Department of Homeland Security, Temporary Final Rule, Prioritization and Allocation of Certain Scarce or Threatened Health and Medical Resources for Domestic Use, 44 C.F.R. part 328, 85 Fed. Reg. 20195 (Apr. 10, 2020) (Ex. SEC-01-013)
President (Memorandum for the Secretaries of HHS and Homeland Security), Memorandum on Allocating Certain Scarce or Threatened Health and Medical Resources to Domestic Use (Apr. 3, 2020) (Ex. SEC-10-013)
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)
Secretary of Defense Mark T. Esper, Memorandum, Guidance for Commanders on Risk-Based Changing of Health Protection Condition Levels During the Coronavirus Disease 2019 Pandemic (May 19, 2020) (Ex. AGY-DEFENSE-GUARD-044)
Chief Management Officer of the Department of Defense, Memorandum, COVID-19 - Move to Health Protection Condition BRAVO PLUS (HPCON B+) of the Pentagon Reservation Plan for Resilience (Nov. 24, 2020) (Ex. AGY-DEFENSE-GUARD-052)
Director of Administration and Management (Michael B. Donley), Memorandum, Coronavirus Disease 2019 - Transition to Health Protection Condition Bravo on the Pentagon Reservation (July 30, 2021) (Ex. AGY-DEFENSE-GUARD-083)
Director of Administration and Management, Memorandum, Coronavirus Disease 2019 - Transition to Health Protection Condition Bravo Plus on the Pentagon Reservation (Sept. 7, 2021) (Ex. AGY-DEFENSE-GUARD-115)
Centers for Disease Control and Prevention and Occupational Safety and Health Administration (joint), Meat and Poultry Processing Workers and Employers: Interim Guidance from CDC and the Occupational Safety and Health Administration (OSHA) (Apr. 26, 2020) (Ex. DUT-FED-061)
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)
Alex M. Azar II, Secretary of Health and Human Services, Emergency Use Authorization Declaration (drugs and biological products), 85 Fed. Reg. 18250 (Apr. 1, 2020) (Mar. 27, 2020) (Ex. AGY-FED-HEALTH-OTHER-037)
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)
Director, Defense Health Agency, DHA-AI 3020.01, Return to the Workplace Staffing Plan in the COVID-19 Environment (June 4, 2020; published June 12, 2020) (Ex. AGY-DEFENSE-GUARD-029)
Food and Drug Administration, HHS, Notice, Guidance Documents Related to Coronavirus Disease 2019 (COVID-19); Availability, 85 Fed. Reg. 27987 (May 12, 2020) (Ex. AGY-FED-HEALTH-OTHER-033)
President (Executive Order 13910), Executive Order 13910, Preventing Hoarding of Health and Medical Resources To Respond to the Spread of COVID-19 (Mar. 23, 2020) (Ex. SEC-10-002)
President (Executive Order 13911), Executive Order 13911, Delegating Additional Authority Under the Defense Production Act With Respect to Health and Medical Resources To Respond to the Spread of COVID-19 (Mar. 27, 2020) (Ex. SEC-10-003)
President Donald J. Trump, Executive Order 13909 (Mar. 18, 2020) (Ex. ECO-A-060)
FEMA, Temporary Final Rule, Prioritization and Allocation of Certain Scarce or Threatened Health and Medical Resources for Domestic Use; Exemptions, 85 Fed. Reg. 22021 (Apr. 21, 2020) (Apr. 17, 2020) (Ex. ECO-A-065)
FEMA, Temporary Final Rule, Prioritization and Allocation of Certain Scarce and Critical Health and Medical Resources for Domestic Use, 85 Fed. Reg. 48113 (Aug. 10, 2020) (Ex. ECO-A-066)
FEMA, Temporary Final Rule, Prioritization and Allocation of Certain Scarce and Critical Health and Medical Resources for Domestic Use, 85 Fed. Reg. 86835 (Dec. 31, 2020) (Ex. ECO-A-067)
FEMA, Temporary Final Rule, Prioritization and Allocation of Certain Scarce and Critical Health and Medical Resources for Domestic Use; Additional Exemptions, 86 Fed. Reg. 31448 (June 14, 2021) (Ex. ECO-A-068)
FEMA, Correction, Prioritization and Allocation of Certain Scarce or Threatened Health and Medical Resources for Domestic Use, 85 Fed. Reg. 22622 (Apr. 23, 2020) (Ex. ECO-A-075)
FEMA, Department of Homeland Security, Prioritization and Allocation of Certain Scarce or Threatened Health and Medical Resources for Domestic Use, temporary final rule, 85 Fed. Reg. 20195 (Apr. 10, 2020) (Ex. SEC-02-010)
Federal Emergency Management Agency, DHS, Temporary final rule, Prioritization and Allocation of Certain Scarce or Threatened Health and Medical Resources for Domestic Use, 44 C.F.R. part 328 (Apr. 10, 2020) (Ex. SEC-10-004)
President (Executive Order 13944), Executive Order 13944, Combating Public Health Emergencies and Strengthening National Security by Ensuring Essential Medicines, Medical Countermeasures, and Critical Inputs Are Made in the United States (Aug. 6, 2020) (Ex. SEC-10-006)
FEMA, DHS, Temporary final rule, Prioritization and Allocation of Certain Scarce and Critical Health and Medical Resources for Domestic Use (extension with modifications) (Aug. 10, 2020) (Ex. SEC-10-008)
FEMA, DHS, Temporary final rule, Prioritization and Allocation of Certain Scarce and Critical Health and Medical Resources for Domestic Use (second extension) (Dec. 31, 2020) (Ex. SEC-10-009)
Centers for Disease Control and Prevention, HHS, Notice, Temporary Suspension of Dogs Entering the United States From High-Risk Rabies Countries, 86 Fed. Reg. 32041 (June 16, 2021) (Ex. AGY-FED-HEALTH-OTHER-126)
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)
Denise M. Hinton, Chief Scientist, FDA, Emergency Use Authorization: Face Shields (umbrella) (issued Apr. 9, 2020; amended Apr. 13, 2020) (Ex. AGY-FED-HEALTH-OTHER-053)
President, Executive Order 13909 (Mar. 18, 2020) (Ex. SEC-01-014)
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)
Director, Defense Health Agency, DHA-AI 3020.01, Change 2 (Nov. 3, 2020) (Ex. AGY-DEFENSE-GUARD-030)
Denise M. Hinton, Chief Scientist, FDA, Emergency Use Authorization: Gowns and Other Apparel (umbrella) (May 22, 2020) (Ex. AGY-FED-HEALTH-OTHER-054)
President Donald J. Trump, Executive Order 13911 (Mar. 27, 2020) (Ex. ECO-A-063)
President Donald J. Trump, Executive Order 13910 (Mar. 23, 2020) (Ex. FED-071)
President Donald J. Trump, Executive Order 13911 (Mar. 27, 2020) (Ex. FED-072)
Federal Emergency Management Agency, DHS, Temporary Final Rule extending and modifying the PPE allocation rule (Dec. 31, 2020) (Ex. FED-078)
President, Executive Order 13911 (Mar. 27, 2020) (Ex. SEC-01-022)
Food and Drug Administration, HHS, Notice, Revocation of Authorization of Emergency Use of Certain Medical Devices During COVID-19; Availability, 86 Fed. Reg. 48712 (Aug. 31, 2021) (Ex. AGY-FED-HEALTH-OTHER-048)
William T. McDermott, Assistant Administrator, Diversion Control Division, DEA, DEA-DC-027 (DEA083), letter to DEA-registered distributors and manufacturers granting an exception to the signed-delivery requirement for narcotic shipments to narcotic treatment programs (Apr. 10, 2020) (Ex. AGY-FED-HEALTH-OTHER-017)
Food and Drug Administration, HHS, Notice, Authorization of Emergency Use of Certain Medical Devices During COVID-19; Availability, 85 Fed. Reg. 34638 (June 5, 2020) (Ex. AGY-FED-HEALTH-OTHER-034)
Denise M. Hinton, Chief Scientist, FDA (letter to Battelle Memorial Institute), 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) (Ex. AGY-FED-HEALTH-OTHER-050)
Food and Drug Administration (Office of the Chief Scientist), Emergency Use Authorization: Surgical Masks (umbrella) (issued Aug. 5, 2020; reissued Mar. 6, 2023) (Ex. AGY-FED-HEALTH-OTHER-055)
President Donald J. Trump, Executive Order 13910 (Mar. 23, 2020) (Ex. ECO-A-061)
Federal Emergency Management Agency, DHS, Notification of Exemptions to the PPE allocation rule (Apr. 17, 2020) (Ex. FED-076)
Federal Emergency Management Agency, DHS, Temporary Final Rule extending and modifying the PPE allocation rule (Aug. 10, 2020) (Ex. FED-077)
Federal Emergency Management Agency, DHS, Notification of Additional Exemptions to the PPE allocation rule (June 11, 2021) (Ex. FED-079)
Occupational Safety and Health Administration, U.S. Department of Labor, Occupational Exposure to COVID-19; Emergency Temporary Standard, 29 C.F.R. 1910.502, 86 Fed. Reg. 32376 (June 21, 2021) (Ex. FED-080)
Secretary of Health and Human Services, Emergency Use Declaration: personal respiratory protective devices (Mar. 2, 2020) (Ex. FED-182)
President, Executive Order 13910 (Mar. 23, 2020) (Ex. SEC-01-015)
William T. McDermott, Assistant Administrator, Diversion Control Division, DEA, DEA-DC-029 (DEA085), letter granting a temporary exception to the five percent rule for practitioners distributing controlled substances to other registrants during the COVID-19 emergency (Apr. 13, 2020) (Ex. AGY-FED-HEALTH-OTHER-019)
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)
Federal Bureau of Prisons, Bureau to Resume Social Visitation: non-contact social visits to resume Oct. 3, 2020 under Phase Nine modifications (Sept. 30, 2020) (Ex. AGY-FED-HEALTH-OTHER-078)
Occupational Safety and Health Administration, Guidance on Returning to Work (OSHA 4045, June 2020) (June 17, 2020) (Ex. DUT-FED-013)
Secretary of Health and Human Services (Xavier Becerra), Extension of Designation of Scarce Materials or Threatened Materials Subject to COVID-19 Hoarding Prevention Measures; Extension of Effective Date With Modifications, 86 Fed. Reg. 35810 (July 7, 2021) (Ex. ECO-A-071)
Secretary of Health and Human Services, Notice of Designation of Scarce Materials or Threatened Materials Subject to COVID-19 Hoarding Prevention Measures (Mar. 25, 2020) (Ex. FED-074)
Secretary of Health and Human Services, Emergency Use Authorization Declaration: medical devices, including alternative products used as medical devices (Mar. 24, 2020) (Ex. FED-183)
Secretary of Health and Human Services, Notice of Designation of Scarce Materials or Threatened Materials Subject to COVID-19 Hoarding Prevention Measures, 85 Fed. Reg. 17592 (Mar. 30, 2020) (Mar. 25, 2020) (Ex. SEC-07-006)
OSHA, Directorate of Enforcement Programs (Patrick J. Kapust, Acting Director), to Regional Administrators and State Plan Designees, Memorandum, Temporary Enforcement Guidance - Healthcare Respiratory Protection Annual Fit-Testing for N95 Filtering Facepieces During the COVID-19 Outbreak (Mar. 14, 2020) (Ex. AGY-FED-LABOR-IMMIGRATION-015)
Secretary of Health and Human Services (Alex M. Azar II), Notice of Designation of Scarce Materials or Threatened Materials Subject to COVID-19 Hoarding Prevention Measures, 85 Fed. Reg. 17592 (Mar. 30, 2020) (Mar. 25, 2020) (Ex. ECO-A-062)
Secretary of Health and Human Services, Extension of Designation of Scarce Materials or Threatened Materials Subject to COVID-19 Hoarding Prevention Measures Under Executive Order 13910 and Section 102 of the Defense Production Act of 1950, 85 Fed. Reg. 45895 (July 30, 2020) (Ex. ECO-A-069)
Acting Secretary of Health and Human Services, Extension of Designation of Scarce Materials or Threatened Materials Subject to COVID-19 Hoarding Prevention Measures; Extension of Effective Date With Modifications, 86 Fed. Reg. 7731 (Feb. 1, 2021) (Ex. ECO-A-070)
Centers for Disease Control and Prevention with the South Dakota Department of Health (Steinberg et al.), COVID-19 Outbreak Among Employees at a Meat Processing Facility - South Dakota, March-April 2020, MMWR 69(31):1015-1019 (Aug. 7, 2020) (Ex. ECO-A-082)
Centers for Disease Control and Prevention, HHS, Temporary Extension and Modification of the Framework for Conditional Sailing Order (Oct. 25, 2021) (Ex. FED-033)
CDC, HHS, Temporary Extension and Modification of Framework for Conditional Sailing Order (Oct. 25, 2021), 86 Fed. Reg. 59720 (Oct. 28, 2021) (Ex. SEC-06-007)
Secretary of Health and Human Services, Extension of Designation of Scarce Materials or Threatened Materials Subject to COVID-19 Hoarding Prevention Measures; Extension of Effective Date With Modifications, 86 Fed. Reg. 35810 (July 7, 2021) (Ex. SEC-07-031)
Secretary of Health and Human Services, Extension of Designation of Scarce Materials or Threatened Materials Subject to COVID-19 Hoarding Prevention Measures, 85 Fed. Reg. 45895 (July 30, 2020) (July 23, 2020) (Ex. SEC-07-034)
Secretary of Health and Human Services, Extension of Designation of Scarce Materials or Threatened Materials; Correction of Extension Date, 85 Fed. Reg. 83975 (Dec. 23, 2020) (Ex. SEC-07-035)
Secretary of Health and Human Services, Extension of Designation of Scarce Materials or Threatened Materials; Extension of Effective Date With Modifications, 86 Fed. Reg. 7731 (Feb. 1, 2021) (Ex. SEC-07-036)
OSHA Directorate of Enforcement Programs to Regional Administrators and State Plan Designees, Memorandum, Enforcement Guidance for Respiratory Protection and the N95 Shortage Due to the Coronavirus Disease 2019 (COVID-19) Pandemic (Apr. 3, 2020) (Ex. AGY-FED-LABOR-IMMIGRATION-016)
OSHA Directorate of Enforcement Programs, Memorandum, Enforcement Guidance on Decontamination of Filtering Facepiece Respirators in Healthcare During the COVID-19 Pandemic (Apr. 24, 2020) (Ex. AGY-FED-LABOR-IMMIGRATION-022)
Centers for Disease Control and Prevention, Considerations for Restaurants and Bars (updated May 27, 2020) (Ex. DUT-FED-064)
U.S. Department of Transportation (Office of the Secretary), U.S. Department of Transportation COVID-19 Workplace Safety Plan (Feb. 19, 2021) (Ex. AGY-AVIATION-SURFACE-038)
U.S. Department of Transportation, U.S. Department of Transportation COVID-19 Workplace Safety Plan, updated June 25, 2021 (Ex. AGY-AVIATION-SURFACE-039)
Principal Director, Defense Pricing and Contracting, Class Deviation 2020-O0013, CARES Act Section 3610 Implementation (Apr. 8, 2020), with DFARS 231.205-79 (Ex. AGY-DEFENSE-GUARD-061)
96th Test Wing, Eglin AFB (published on eglin.af.mil), COVID-19: Service reductions, closures, cancellations, updates (running notice, published Apr. 16, 2020; first posted Mar. 20, 2020) (Ex. AGY-DEFENSE-GUARD-103)
Joint Base Lewis-McChord (I Corps; 62d Airlift Wing memorandum of Aug. 12, 2021 for Team McChord), JBLM COVID-19 Response Factsheet (as of Aug. 18, 2021) (Ex. AGY-DEFENSE-GUARD-134)
Secretary of Homeland Security (Acting Secretary Chad F. Wolf), through USCIS, Temporary final rule, Temporary Changes to Requirements Affecting H-2A Nonimmigrants Due to the COVID-19 National Emergency, 85 Fed. Reg. 21739 (Apr. 20, 2020), adding 8 C.F.R. 214.2(h)(21) (Ex. AGY-FED-LABOR-IMMIGRATION-003)
Secretary of Homeland Security, through USCIS, Temporary final rule, Temporary Changes to Requirements Affecting H-2B Nonimmigrants Due to the COVID-19 National Emergency, 85 Fed. Reg. 28843 (May 14, 2020), adding 8 C.F.R. 214.2(h)(23) (Ex. AGY-FED-LABOR-IMMIGRATION-004)
Secretary of Homeland Security, through USCIS, Temporary final rule, Temporary Changes to Requirements Affecting H-2A Nonimmigrants Due To the COVID-19 National Emergency: Partial Extension of Certain Flexibilities, 85 Fed. Reg. 51304 (Aug. 20, 2020) (Ex. AGY-FED-LABOR-IMMIGRATION-005)
Secretary of Homeland Security, through USCIS, Temporary final rule, Temporary Changes to Requirements Affecting H-2A Nonimmigrants Due to the COVID-19 National Emergency: Extension of Certain Flexibilities, 85 Fed. Reg. 82291 (Dec. 18, 2020) (Ex. AGY-FED-LABOR-IMMIGRATION-006)
OSHA Directorate of Enforcement Programs, Memorandum, Expanded Temporary Enforcement Guidance on Respiratory Protection Fit-Testing for N95 Filtering Facepieces in All Industries During the COVID-19 Pandemic (Apr. 8, 2020) (Ex. AGY-FED-LABOR-IMMIGRATION-018)
Secretary of Agriculture Sonny Perdue (USDA Office of Communications release), USDA press release, 'USDA To Implement President Trump's Executive Order On Meat and Poultry Processors' (Apr. 28, 2020) (Ex. AGY-FED-LANDS-SCIENCE-COURTS-006)
Centers for Disease Control and Prevention, COVID-19 Response Team (Dyal et al.), COVID-19 Among Workers in Meat and Poultry Processing Facilities - 19 States, April 2020, MMWR 69(18):557-561 (early release May 1, 2020; May 8, 2020) (Ex. ECO-A-080)
President Donald J. Trump, Executive Order 13917, Delegating Authority Under the Defense Production Act With Respect to Food Supply Chain Resources, 85 Fed. Reg. 26313 (Apr. 28, 2020) (Ex. FED-073)
CMS, Quality, Safety & Oversight Group, QSO-20-30-NH, Nursing Home Reopening Recommendations for State and Local Officials (May 18, 2020; REVISED Mar. 10, 2021; expired Mar. 10, 2021) (Ex. FED-157)
The President and the White House Coronavirus Task Force, Guidelines for Opening Up America Again (Apr. 16, 2020) (Ex. FED-192)
Congress (Pub. L. 116-136), CARES Act s. 3222 (Nutrition Services) and s. 3223 (Continuity of Service... Under Title V of the Older Americans Act) (Mar. 27, 2020) (Ex. SEC-24-002)
