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
PL 115-92 (H.R.4374), enacted 12/12/2017

131 STAT. 2023 
PUBLIC LAW 115–92—DEC. 12, 2017 
Public Law 115–92 
115th Congress 
An Act 
To amend the Federal Food, Drug, and Cosmetic Act to authorize additional emer-
gency 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 Representatives of 
the United States of America in Congress assembled, 
SECTION 1. ADDITIONAL EMERGENCY USES FOR MEDICAL PRODUCTS 
TO REDUCE DEATHS AND SEVERITY 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 Cos-
metic Act (21 U.S.C. 360bbb–3) is amended— 
(1) in subsection (b)— 
(A) in paragraph (1), by amending subparagraph (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, radiological, or nuclear 
agent or agents; or 
‘‘(ii) an agent or agents that may cause, or are 
otherwise associated with, an imminently life-threat-
ening and specific risk to United States military 
forces;’’; and 
(B) by adding at the end the following: 
‘‘(6) MILITARY EMERGENCIES.—In the case of a determina-
tion described in paragraph (1)(B), the Secretary shall deter-
mine, within 45 calendar days of such determination, whether 
to make a declaration 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 emergency use is made by 
the Secretary of Defense; and’’. 
(b) EMERGENCY USES FOR MEDICAL PRODUCTS.— 
21 USC 
360bbb–3c. 
Time period. 
Determinations. 
Dec. 12, 2017 
[H.R. 4374] 
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131 STAT. 2024 
PUBLIC LAW 115–92—DEC. 12, 2017 
(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 development of a medical product, review of 
investigational new drug applications under section 505(i) of 
the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(i)), 
review of investigational device exemptions under section 520(g) 
of such Act (21 U.S.C. 360j(g)), and review of applications 
for approval and clearance of medical products under sections 
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 applications for licensing of vaccines or blood 
as biological 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 spe-
cific and imminently life-threatening risk to United States mili-
tary forces of attack with an agent or agents, and the medical 
product that is the subject of such application, 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 Serv-
ices, acting through the Commissioner of Food and Drugs, 
shall take action to expedite the development and review of 
an applicable application or notification with respect to a med-
ical 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 interactive commu-
nication with, the sponsor regarding the development of 
the medical product to ensure that the development pro-
gram to gather the nonclinical and clinical data necessary 
for approval or clearance is as efficient as practicable; 
(C) involving senior managers and experienced review 
staff, as appropriate, in a collaborative, cross-disciplinary 
review; 
(D) assigning a cross-disciplinary project lead for the 
review team to facilitate an efficient review of the develop-
ment 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 practicable, when scientifically 
appropriate, such as by minimizing the number of patients 
exposed to a potentially less efficacious treatment; 
(F) applying any applicable Food and Drug Administra-
tion program intended to expedite the development and 
review of a medical product; and 
(G) in appropriate circumstances, permitting expanded 
access to the medical product during the investigational 
phase, in accordance with applicable requirements of the 
Food and Drug Administration. 
(3) ENHANCED COLLABORATION AND COMMUNICATION.—In 
order to facilitate enhanced collaboration and communication 
Time periods. 
Determination. 
Review. 
Notification. 
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131 STAT. 2025 
PUBLIC LAW 115–92—DEC. 12, 2017 
LEGISLATIVE HISTORY—H.R. 4374: 
CONGRESSIONAL RECORD, Vol. 163 (2017): 
Nov. 15, considered and passed House. 
Nov. 16, considered and passed Senate. 
with respect to the most current priorities of the Department 
of Defense— 
(A) the Food and Drug Administration shall meet with 
the Department of Defense and any other appropriate 
development partners, such as the Biomedical Advanced 
Research and Development Authority, on a semi-annual 
basis for the purposes of conducting a full review of the 
relevant products in the Department of Defense portfolio; 
and 
(B) the Director of the Center for Biologics Evaluation 
and Research shall meet quarterly with the Department 
of Defense to discuss the development status of regenera-
tive medicine advanced therapy, blood, and vaccine medical 
products and projects that are the highest priorities to 
the Department of Defense (which may include freeze dried 
plasma products and platelet alternatives), 
unless the Secretary of Defense determines that any such 
meetings are not necessary. 
(4) MEDICAL PRODUCT.—In this subsection, the term ‘‘med-
ical product’’ means a drug (as defined in section 201 of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321)), a device 
(as defined in such section 201), or a biological product (as 
defined in section 351 of the Public Health Service Act (42 
U.S.C. 262)). 
(c) REPEAL.—Effective as of the enactment of the National 
Defense Authorization Act for Fiscal Year 2018, subsection (d) of 
section 1107a of title 10, United States Code, as added by section 
716 of the National Defense Authorization Act for Fiscal Year 
2018, is repealed. 
Approved December 12, 2017. 
Effective date. 
10 USC 1107a 
note. 
Definition. 
Review. 
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