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DOD/DODOASHA RIN: 0720-AB31 Publication ID: Spring 2011 
Title: TRICARE; Coverage of National Cancer Institute (NCI) Sponsored Phase I Studies 
Abstract: This rule adds coverage of National Cancer Institute (NCI) sponsored Phase I studies for certain beneficiaries. The NCI sponsored clinical treatment trials are conducted in a series of steps called phases. Phase I trials are the first studies conducted in people. They evaluate how a new drug should be given (by mouth, injected into the blood, or injected into the muscle), how often, and what dose is safe. 
Agency: Department of Defense(DOD)  Priority: Substantive, Nonsignificant 
RIN Status: Previously published in the Unified Agenda Agenda Stage of Rulemaking: Completed Actions 
Major: No  Unfunded Mandates: No 
CFR Citation: 32 CFR 199   
Legal Authority: 10 USC ch 55    5 USC 301   
Legal Deadline:  None
Timetable:
Action Date FR Cite
NPRM  06/22/2009  74 FR 29435   
NPRM Comment Period End  08/21/2009    
Final Action  01/13/2011  76 FR 2253   
Final Action Effective  02/14/2011    
Regulatory Flexibility Analysis Required: No  Government Levels Affected: None 
Small Entities Affected: No  Federalism: No 
Included in the Regulatory Plan: No 
RIN Data Printed in the FR: No 
Agency Contact:
John Kugler
Department of Defense
Office of Assistant Secretary for Health Affairs
1200 Defense Pentagon,
Washington, DC 20301-1200
Phone:703 681-0064
Email: john.kugler@tma.osd.mil