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. 

1 Be it enacted by the Senate and House of Representa2 tives of the United States of America in Congress assembled, 


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1 SECTION 1. ADDITIONAL EMERGENCY USES FOR MEDICAL 

2 PRODUCTS TO REDUCE DEATHS AND SEVER3 ITY OF INJURIES CAUSED BY AGENTS OF 

4 WAR. 

5 (a) FDA AUTHORIZATION FOR MEDICAL PRODUCTS

6 FOR USE IN EMERGENCIES.—Section 564 of the Federal 

7 Food, Drug, and Cosmetic Act (21 U.S.C. 360bbb–3) is 

8 amended— 

9 (1) in subsection (b)— 

10 (A) in paragraph (1), by amending sub11 paragraph (B) to read as follows: 

12 ‘‘(B) a determination by the Secretary of 

13 Defense that there is a military emergency, or 

14 a significant potential for a military emergency, 

15 involving a heightened risk to United States 

16 military forces, including personnel operating 

17 under the authority of title 10 or title 50, 

18 United States Code, of attack with— 

19 ‘‘(i) a biological, chemical, radio20 logical, or nuclear agent or agents; or 

21 ‘‘(ii) an agent or agents that may 

22 cause, or are otherwise associated with, an 

23 imminently life-threatening and specific 

24 risk to United States military forces;’’; and 

25 (B) by adding at the end the following: 


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1 ‘‘(6) MILITARY EMERGENCIES.—In the case of 

2 a determination described in paragraph (1)(B), the 

3 Secretary shall determine, within 45 calendar days 

4 of such determination, whether to make a declara5 tion under paragraph (1), and, if appropriate, shall 

6 promptly make such a declaration.’’; and 

7 (2) in subsection (c)— 

8 (A) in paragraph (3), by striking ‘‘; and’’ 

9 and inserting ‘‘;’’; 

10 (B) by redesignating paragraph (4) as 

11 paragraph (5); and 

12 (C) by inserting after paragraph (3) the 

13 following: 

14 ‘‘(4) in the case of a determination described in 

15 subsection (b)(1)(B)(ii), that the request for emer16 gency use is made by the Secretary of Defense; 

17 and’’. 

18 (b) EMERGENCY USES FOR MEDICAL PRODUCTS.— 

19 (1) IN GENERAL.—The Secretary of Defense 

20 may request that the Secretary of Health and 

21 Human Services, acting through the Commissioner 

22 of Food and Drugs, take actions to expedite the de23 velopment of a medical product, review of investiga24 tional new drug applications under section 505(i) of 

25 the Federal Food, Drug, and Cosmetic Act (21 


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1 U.S.C. 355(i)), review of investigational device ex2 emptions under section 520(g) of such Act (21 

3 U.S.C. 360j(g)), and review of applications for ap4 proval and clearance of medical products under sec5 tions 505, 510(k), and 515 of such Act (21 U.S.C. 

6 355, 360(k), 360(e)) and section 351 of the Public 

7 Health Service Act (42 U.S.C. 262), including appli8 cations for licensing of vaccines or blood as biologi9 cal products under such section 351, or applications 

10 for review of regenerative medicine advanced therapy 

11 products under section 506(g) of the Federal Food, 

12 Drug, and Cosmetic Act (21 U.S.C. 356(g)), if there 

13 is a military emergency, or significant potential for 

14 a military emergency, involving a specific and immi15 nently life-threatening risk to United States military 

16 forces of attack with an agent or agents, and the 

17 medical product that is the subject of such applica18 tion, submission, or notification would be reasonably 

19 likely to diagnose, prevent, treat, or mitigate such 

20 life-threatening risk. 

21 (2) ACTIONS.—Upon a request by the Secretary 

22 of Defense under paragraph (1), the Secretary of 

23 Health and Human Services, acting through the 

24 Commissioner of Food and Drugs, shall take action 

25 to expedite the development and review of an appliVerDate Sep 11 2014 01:19 Nov 17, 2017 Jkt 079200 PO 00000 Frm 00004 Fmt 6652 Sfmt 6201 E:\BILLS\H4374.RDS H4374

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1 cable application or notification with respect to a 

2 medical product described in paragraph (1), which 

3 may include, as appropriate— 

4 (A) holding meetings with the sponsor and 

5 the review team throughout the development of 

6 the medical product; 

7 (B) providing timely advice to, and inter8 active communication with, the sponsor regard9 ing the development of the medical product to 

10 ensure that the development program to gather 

11 the nonclinical and clinical data necessary for 

12 approval or clearance is as efficient as prac13 ticable; 

14 (C) involving senior managers and experi15 enced review staff, as appropriate, in a collabo16 rative, cross-disciplinary review; 

17 (D) assigning a cross-disciplinary project 

18 lead for the review team to facilitate an effi19 cient review of the development program and to 

20 serve as a scientific liaison between the review 

21 team and the sponsor; 

22 (E) taking steps to ensure that the design 

23 of the clinical trials is as efficient as prac24 ticable, when scientifically appropriate, such as 


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1 by minimizing the number of patients exposed 

2 to a potentially less efficacious treatment; 

3 (F) applying any applicable Food and 

4 Drug Administration program intended to expe5 dite the development and review of a medical 

6 product; and 

7 (G) in appropriate circumstances, permit8 ting expanded access to the medical product 

9 during the investigational phase, in accordance 

10 with applicable requirements of the Food and 

11 Drug Administration. 

12 (3) ENHANCED COLLABORATION AND COMMU13 NICATION.—In order to facilitate enhanced collabo14 ration and communication with respect to the most 

15 current priorities of the Department of Defense— 

16 (A) the Food and Drug Administration 

17 shall meet with the Department of Defense and 

18 any other appropriate development partners, 

19 such as the Biomedical Advanced Research and 

20 Development Authority, on a semi-annual basis 

21 for the purposes of conducting a full review of 

22 the relevant products in the Department of De23 fense portfolio; and 

24 (B) the Director of the Center for Bio25 logics Evaluation and Research shall meet quarVerDate Sep 11 2014 01:19 Nov 17, 2017 Jkt 079200 PO 00000 Frm 00006 Fmt 6652 Sfmt 6201 E:\BILLS\H4374.RDS H4374

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1 terly with the Department of Defense to discuss 

2 the development status of regenerative medicine 

3 advanced therapy, blood, and vaccine medical 

4 products and projects that are the highest pri5 orities to the Department of Defense (which 

6 may include freeze dried plasma products and 

7 platelet alternatives), 

8 unless the Secretary of Defense determines that any 

9 such meetings are not necessary. 

10 (4) MEDICAL PRODUCT.—In this subsection, 

11 the term ‘‘medical product’’ means a drug (as de12 fined in section 201 of the Federal Food, Drug, and 

13 Cosmetic Act (21 U.S.C. 321)), a device (as defined 

14 in such section 201), or a biological product (as de15 fined in section 351 of the Public Health Service Act 

16 (42 U.S.C. 262)). 

17 (c) REPEAL.—Effective as of the enactment of the 

18 National Defense Authorization Act for Fiscal Year 2018, 

19 subsection (d) of section 1107a of title 10, United States 


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1 Code, as added by section 716 of the National Defense 

2 Authorization Act for Fiscal Year 2018, is repealed. 

Passed the House of Representatives November 15, 

2017. 

Attest: KAREN L. HAAS, 

Clerk. 


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