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DOD/DODOASHA RIN: 0720-AB83 Publication ID: Spring 2023 
Title: TRICARE Coverage of Clinical Trials and Termination of Expanded Access Treatments 
Abstract:

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).

 

 
Agency: Department of Defense(DOD)  Priority: Other Significant 
RIN Status: Previously published in the Unified Agenda Agenda Stage of Rulemaking: Final Rule Stage 
Major: No  Unfunded Mandates: No 
CFR Citation: 32 CFR 199   
Legal Authority: 5 U.S.C. 301    10 U.S.C. ch 55   
Legal Deadline:  None
Timetable:
Action Date FR Cite
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 
Additional Information: 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."
Regulatory Flexibility Analysis Required: Undetermined  Government Levels Affected: Undetermined 
Federalism: No 
Included in the Regulatory Plan: Yes 
RIN Data Printed in the FR: No 
Related RINs: Related to 0720-AB81, Related to 0720-AB82 
Agency Contact:
Jennifer Stankovic
Department of Defense
Office of Assistant Secretary for Health Affairs
16401 E Centretech Parkway,
Aurora, CO 80011-9066
Phone:303 676-3742
Email: jennifer.l.stankovic.civ@health.mil