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DOD/DODOASHA RIN: 0720-AB23 Publication ID: Spring 2011 
Title: TRICARE; Off-Label Uses of Devices; Partial List of Examples of Unproven Drugs, Devices, and Medical Treatments or Procedures 
Abstract: This rule revises the definition of "unlabeled or off-label drug" to "off-label use of a drug or device." This revision is consistent with the regulatory framework under the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq). Additionally, this rule removes the partial list of examples of unproven drugs, devices, and medical treatments or procedures proscribed under section 199.4(g)(15). As it is determined that reliable evidence demonstrates that previously unproven drugs, devices, and medical treatments or procedures have proven medical effectiveness, TRICARE has removed them from the list and authorized medically necessary care. This removal of the partial list is necessary as the list will never be completely current and is only a partial list of examples. The removal of this partial list does not change or eliminate any benefits that are currently available under the TRICARE program. 
Agency: Department of Defense(DOD)  Priority: Substantive, Nonsignificant 
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 USC 301    10 USC ch 55   
Legal Deadline:  None
Action Date FR Cite
NPRM  08/10/2004  69 FR 48433   
NPRM Comment Period End  10/12/2004    
Second NPRM  08/31/2009  74 FR 44797   
Second NPRM Comment Period End  10/30/2009    
Final Action  06/00/2011    
Regulatory Flexibility Analysis Required: No  Government Levels Affected: None 
Federalism: No 
Included in the Regulatory Plan: No 
RIN Data Printed in the FR: No 
Related RINs: Previously reported as 0720-AA88 
Agency Contact:
Rene Morrell
Department of Defense
Office of Assistant Secretary for Health Affairs
1200 Defense Pentagon,
Washington, DC 20301
Phone:303 676-3618