II 
115TH CONGRESS 
1ST SESSION H. R. 4374 
IN THE SENATE OF THE UNITED STATES 
NOVEMBER 15, 2017 
Received 
AN ACT 
To amend the Federal Food, Drug, and Cosmetic Act to 
authorize additional emergency uses for medical products 
to reduce deaths and severity of injuries caused by 
agents of war, and for other purposes. 
Be it enacted by the Senate and House of Representa-
tives of the United States of America in Congress assembled, 
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SECTION 1. ADDITIONAL EMERGENCY USES FOR MEDICAL 
PRODUCTS TO REDUCE DEATHS AND SEVER-
ITY OF INJURIES CAUSED BY AGENTS OF 
WAR. 
(a) FDA AUTHORIZATION FOR MEDICAL PRODUCTS 
FOR USE IN EMERGENCIES.—Section 564 of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 360bbb–3) is 
amended— 
(1) in subsection (b)— 
(A) in paragraph (1), by amending sub-
paragraph (B) to read as follows: 
‘‘(B) a determination by the Secretary of 
Defense that there is a military emergency, or 
a significant potential for a military emergency, 
involving a heightened risk to United States 
military forces, including personnel operating 
under the authority of title 10 or title 50, 
United States Code, of attack with— 
‘‘(i) a biological, chemical, radio-
logical, or nuclear agent or agents; or 
‘‘(ii) an agent or agents that may 
cause, or are otherwise associated with, an 
imminently life-threatening and specific 
risk to United States military forces;’’; and 
(B) by adding at the end the following: 
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‘‘(6) MILITARY EMERGENCIES.—In the case of 
a determination described in paragraph (1)(B), the 
Secretary shall determine, within 45 calendar days 
of such determination, whether to make a declara-
tion under paragraph (1), and, if appropriate, shall 
promptly make such a declaration.’’; and 
(2) in subsection (c)— 
(A) in paragraph (3), by striking ‘‘; and’’ 
and inserting ‘‘;’’; 
(B) by redesignating paragraph (4) as 
paragraph (5); and 
(C) by inserting after paragraph (3) the 
following: 
‘‘(4) in the case of a determination described in 
subsection (b)(1)(B)(ii), that the request for emer-
gency use is made by the Secretary of Defense; 
and’’. 
(b) EMERGENCY USES FOR MEDICAL PRODUCTS.— 
(1) IN
GENERAL.—The Secretary of Defense 
may request that the Secretary of Health and 
Human Services, acting through the Commissioner 
of Food and Drugs, take actions to expedite the de-
velopment of a medical product, review of investiga-
tional new drug applications under section 505(i) of 
the Federal Food, Drug, and Cosmetic Act (21 
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U.S.C. 355(i)), review of investigational device ex-
emptions under section 520(g) of such Act (21 
U.S.C. 360j(g)), and review of applications for ap-
proval and clearance of medical products under sec-
tions 505, 510(k), and 515 of such Act (21 U.S.C. 
355, 360(k), 360(e)) and section 351 of the Public 
Health Service Act (42 U.S.C. 262), including appli-
cations for licensing of vaccines or blood as biologi-
cal products under such section 351, or applications 
for review of regenerative medicine advanced therapy 
products under section 506(g) of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 356(g)), if there 
is a military emergency, or significant potential for 
a military emergency, involving a specific and immi-
nently life-threatening risk to United States military 
forces of attack with an agent or agents, and the 
medical product that is the subject of such applica-
tion, submission, or notification would be reasonably 
likely to diagnose, prevent, treat, or mitigate such 
life-threatening risk. 
(2) ACTIONS.—Upon a request by the Secretary 
of Defense under paragraph (1), the Secretary of 
Health and Human Services, acting through the 
Commissioner of Food and Drugs, shall take action 
to expedite the development and review of an appli-
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cable application or notification with respect to a 
medical product described in paragraph (1), which 
may include, as appropriate— 
(A) holding meetings with the sponsor and 
the review team throughout the development of 
the medical product; 
(B) providing timely advice to, and inter-
active communication with, the sponsor regard-
ing the development of the medical product to 
ensure that the development program to gather 
the nonclinical and clinical data necessary for 
approval or clearance is as efficient as prac-
ticable; 
(C) involving senior managers and experi-
enced review staff, as appropriate, in a collabo-
rative, cross-disciplinary review; 
(D) assigning a cross-disciplinary project 
lead for the review team to facilitate an effi-
cient review of the development program and to 
serve as a scientific liaison between the review 
team and the sponsor; 
(E) taking steps to ensure that the design 
of the clinical trials is as efficient as prac-
ticable, when scientifically appropriate, such as 
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