Roger T. Severino, Director, Office for Civil Rights, HHS, 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) (Apr. 2, 2020) (Ex. AGY-FED-HEALTH-OTHER-002)
Drug Enforcement Administration, Diversion Control Division (guidance document EO-DEA213), DEA-DC-043 (EO-DEA213), guidance: Administering certain controlled substances in the parking lot of a health care provider's DEA-registered location during the COVID-19 public health emergency (July 28, 2020) (Ex. AGY-FED-HEALTH-OTHER-021)
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)
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)
Roger T. Severino, Director, Office for Civil Rights, HHS, 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) (Apr. 9, 2020) (Ex. AGY-FED-HEALTH-OTHER-003)
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the Coronavirus Disease (COVID-19) Public Health Emergency (Mar. 25, 2020; revised Apr. 2020, May 2020, Sept. 2021; superseded Sept. 5, 2023) (Ex.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)
Department of Veterans Affairs (Robert L. Wilkie, Secretary), Interim Final Rule, Authority of VA Professionals To Practice Health Care, 85 Fed. Reg. 71838 (Nov. 12, 2020) (Ex. AGY-FED-HEALTH-OTHER-061)
Robinsue Frohboese, Acting Director, Office for Civil Rights, HHS, Enforcement Discretion Regarding Online or Web-Based Scheduling Applications for the Scheduling of Individual Appointments for COVID-19 Vaccination During the COVID-19 Nationwide Public Health Emergency, 86 Fed. Reg. 11076 (Feb. 24, 2021) (Jan. 19, 2021) (Ex. AGY-FED-HEALTH-OTHER-005)
Drug Enforcement Administration, Diversion Control Division, DEA-DC-023 (DEA075), How to Prescribe Controlled Substances to Patients During the COVID-19 Public Health Emergency (decision tree) (Mar. 31, 2020) (Ex. AGY-FED-HEALTH-OTHER-015)
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)
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 Standard Menu Items in Chain Restaurants and Similar Retail Food Establishments During the COVID-19 Public Health Emergency (Apr. 2020) (Apr. 1, 2020) (Ex. AGY-FED-HEALTH-OTHER-046)
Secretary of Health and Human Services (terms administered by HRSA), Provider Relief Fund, Acceptance of Terms and Conditions, Relief Fund Payment from Initial $30 Billion General Distribution (Apr. 10, 2020) (Ex. AGY-FED-HEALTH-OTHER-118)
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)
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)
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)
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)
SAMHSA, Center for Substance Abuse Treatment, Division of Pharmacologic Therapies, FAQs: Provision of methadone and buprenorphine for the treatment of Opioid Use Disorder in the COVID-19 emergency (Apr. 21, 2020) (Ex. AGY-FED-HEALTH-OTHER-025)
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)
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)
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)
Office of Head Start, ACF, HHS, Interim Final Rule, Flexibility for Head Start Designation Renewals in Certain Emergencies, 85 Fed. Reg. 78785 (Dec. 7, 2020) (Ex. AGY-FED-HEALTH-OTHER-089)
Thomas W. Prevoznik, Deputy Assistant Administrator, Diversion Control Division, DEA, DEA-DC-018 (DEA067), Dear Registrant letter granting an exception to separate State registration for practitioners dispensing in additional States during the COVID-19 emergency (Mar. 25, 2020) (Ex. AGY-FED-HEALTH-OTHER-011)
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)
SAMHSA, Division of Pharmacologic Therapies, Center for Substance Abuse Treatment, OTP Guidance for Patients Quarantined at Home with the Coronavirus (doorstep delivery protocol) (updated Mar. 30, 2020) (Ex. AGY-FED-HEALTH-OTHER-028)
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)
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)
Drug Enforcement Administration, Diversion Control Division, 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 emergency (Mar. 27, 2020) (Ex. AGY-FED-HEALTH-OTHER-013)
Denise M. Hinton, Chief Scientist, FDA, Emergency Use Authorization: Gowns and Other Apparel (umbrella) (May 22, 2020) (Ex. AGY-FED-HEALTH-OTHER-054)
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)
Thomas W. Prevoznik, Deputy Assistant Administrator, Diversion Control Division, DEA, 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 emergency (Mar. 31, 2020) (Ex. AGY-FED-HEALTH-OTHER-014)
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)
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)
Drug Enforcement Administration, Diversion Control Division (guidance document EO-DEA192), DEA-DC-044 (EO-DEA192), guidance: Telemedicine and separate State registration (July 28, 2020) (Ex. AGY-FED-HEALTH-OTHER-022)
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)
William P. Barr, Attorney General, Memorandum for Director of Bureau of Prisons, Prioritization of Home Confinement As Appropriate in Response to COVID-19 Pandemic (Mar. 26, 2020) (Ex. AGY-FED-HEALTH-OTHER-081)
Food and Nutrition Service, USDA, Final Rule, Supplemental Nutrition Assistance Program: Pandemic Electronic Benefits Transfer (P-EBT) Integrity, 85 Fed. Reg. 70012 (Nov. 4, 2020) (Ex. AGY-FED-HEALTH-OTHER-098)
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)
Food and Drug Administration, HHS, Notice, Process for Making Available Guidance Documents Related to Coronavirus Disease 2019, 85 Fed. Reg. 16949 (Mar. 25, 2020) (Ex. AGY-FED-HEALTH-OTHER-131)
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, DEA-DC-025 (DEA078), Dear Registrant letter permitting opioid treatment programs to use the same off-site location repeatedly to deliver take-home methadone doses without separate registration (Apr. 7, 2020) (Ex. AGY-FED-HEALTH-OTHER-016)
William T. McDermott, Assistant Administrator, Diversion Control Division, DEA, DEA-DC-028 (DEA084), letter permitting DEA-registered hospitals and clinics to handle controlled substances at satellite locations under the existing registration during the COVID-19 emergency (Apr. 10, 2020) (Ex. AGY-FED-HEALTH-OTHER-018)
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)
Thomas W. Prevoznik, Deputy Assistant Administrator, Diversion Control Division, DEA, DEA-DC-030 (DEA087), letter extending the off-site take-home delivery flexibility to buprenorphine dispensed by opioid treatment programs (Apr. 21, 2020) (Ex. AGY-FED-HEALTH-OTHER-020)
Food and Drug Administration, HHS, Notice, Process for Publishing Emergency Use Authorizations for Medical Devices During Coronavirus Disease 2019, 85 Fed. Reg. 33686 (June 2, 2020) (Ex. AGY-FED-HEALTH-OTHER-035)
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)
Department of Veterans Affairs, Interim Final Rule, Home Visits in Program of Comprehensive Assistance for Family Caregivers During COVID-19 National Emergency, 85 Fed. Reg. 34523 (June 5, 2020) (Ex. AGY-FED-HEALTH-OTHER-062)
Department of Veterans Affairs, Interim Final Rule, Informed Consent and Advance Directives, 85 Fed. Reg. 31698 (May 27, 2020) (Ex. AGY-FED-HEALTH-OTHER-063)
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)
Bureau of Prisons, Department of Justice (Michael Carvajal, Director), Final Rule, Video Visiting and Telephone Calls Under the Coronavirus Aid, Relief, and Economic Security (CARES) Act, 85 Fed. Reg. 37331 (June 22, 2020) (Ex. AGY-FED-HEALTH-OTHER-071)
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)
Federal Bureau of Prisons, Temporary Security Measures Implemented: all institutions secured (Jan. 16, 2021; lifted Jan. 21, 2021) (Ex. AGY-FED-HEALTH-OTHER-079)
Federal Bureau of Prisons, COVID-19 Vaccination Status: more than 50,000 doses administered (Feb. 23, 2021) (context) (Ex. AGY-FED-HEALTH-OTHER-080)
William P. Barr, Attorney General, Memorandum for Director of Bureau of Prisons, Increasing Use of Home Confinement at Institutions Most Affected by COVID-19 (Apr. 3, 2020) (Ex. AGY-FED-HEALTH-OTHER-082)
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)
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)
