scope:

APPLICABILITY AND SCOPE

This Instruction:

Applies to the Office of the Secretary of Defense, the Military Departments, the Chairman of the Joint Chiefs of Staff, the Combatant Commands, the Office of the Inspector General of the Department of Defense, the Defense Agencies, the DoD Field Activities, and all other organizational entities within the Department of Defense (hereafter referred to collectively as the "DoD Components").

PURPOSE

This Instruction:

Reissues Reference (a) as a DoD Instruction in accordance with the guidance in Reference (b) and the authority in Reference (c).

Updates policy and assigns responsibility for compliance with Reference (d); sections 1107 and 1107a of title 10, United States Code (U.S.C.) (Reference (e)); Executive Order 13139 (Reference (f)); and Parts 50, 56, 312, Subpart I of Part 314, Subpart G of Part 601 of title 21, Code of Federal Regulations (Reference (g)), for application of FDA rules to force health protection programs of the Department of Defense involving medical products required to be used under an Emergency Use Authorization (EUA) or an investigational new drug (IND) application.

Incorporates responsibilities of the Secretary of the Army as the Lead Component for the use of medical products under EUAs or IND applications.