0720-AB83 202304 Unified Agenda of Federal Regulatory and Deregulatory Actions 0720 Office of Assistant Secretary for Health Affairs DODOASHA 0700 Department of Defense DOD TRICARE Coverage of Clinical Trials and Termination of Expanded Access Treatments

The Department of Defense is finalizing an interim final rule to amend 32 CFR part 199 to include coverage that was temporarily added for the treatment use of investigation drugs under U.S. Food and Drug Administration-approved expanded access programs for the treatment of coronavirus disease 2019 (COVID-19) and for National Institute of Allergy and Infectious Disease-sponsored clinical trials for the treatment or prevention of COVID-19. This rule will also finalize the expanded access provision in the interim final rule titled "TRICARE Coverage of Certain Medical Benefits in Response to the COVID-19 Pandemic” (32 CFR part 199, 0720-AB82), which published in the Federal Register on September 3, 2020 (85 FR 54914-54924).

]]> Other Significant Previously Published in The Unified Agenda Final Rule Stage No No 32 CFR 199 5 U.S.C. 301 10 U.S.C. ch 55 Yes Interim Final Rule 10/30/2020 85 FR 68753 Interim Final Rule Effective 10/30/2020 Interim Final Rule Comment Period End 11/30/2020 Final Action 10/00/2023 The interim final rule was titled "TRICARE Coverage of National Institute of Allergy and Infectious Disease Coronavirus Disease 2019 Clinical Trials." The final rule will be titled "TRICARE Coverage of Clinical Trials and Termination of Expanded Access Treatments." Undetermined Undetermined No No No No 0720-AB81 Related to 0720-AB82 Related to Jennifer Stankovic 0720 Office of Assistant Secretary for Health Affairs DODOASHA 303 676-3742 jennifer.l.stankovic.civ@health.mil 16401 E Centretech Parkway, Aurora CO 80011-9066