H. R. 4374 

One Hundred Fifteenth Congress 

of the 

United States of America 

AT THE FIRST SESSION 

Begun and held at the City of Washington on Tuesday, 

the third day of January, two thousand and seventeen 

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 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 Cosmetic 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-threatening 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 determination described in paragraph (1)(B), the Secretary shall determine, 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.— 
H. R. 4374—2 

(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 specific and imminently 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 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 Services, 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 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 interactive communication with, the sponsor regarding 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 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 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 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 Administration 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 
H. R. 4374—3 

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 regenerative 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 ‘‘medical 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. 

Speaker of the House of Representatives. 

Vice President of the United States and

President of the Senate.