,,ii  #aaeth ,,congress  #ast ,session  
,h4 ,r4 #dcgd  ,,in ,,the ,,senate ,,of 
,,the ,,united ,,states  ,november #ae1 
#bjag,received  ,,an ,,act  ,to amend   
the ,federal ,food1 ,drug1 and ,cosmetic
 ,act to authorize additional emergency 
uses for medical products to reduce     
deaths and severity of injuries caused  
by agents of war1 and for other         
purposes4  #a4 ,additional emergency    
uses for medical products to reduce     
deaths and severity of injuries caused  
by agents of war  7a7 ,,fda             
authorization for medical products for  
use in emergencies ,section #efd of the 
,federal ,food1 ,drug1 and ,cosmetic    
,act 7#ba ,u4,s4,c4 #cfj;bbb-#c7 is     
amended-- 7#a7 in subsection 7b7--  7,a7
 in paragraph 7#a71 by amending         
subparagraph 7,b7 to read as follows3   
7,b7 a determination by the ,secretary  
of ,defense that there is a military    
emergency1 or a significant potential   
for a military emergency1 involving a   
heightened risk to ,united ,states      

military forces1 including personnel    
operating under the authority of title  
#aj or title #ej1 ,united ,states ,code1
 of attack with--  7i7 a biological1    
chemical1 radiological1 or nuclear agent
 or agents2 or  7ii7 an agent or agents 
that may cause1 or are otherwise        
associated with1 an imminently          
life-threatening and specific risk to   
,united ,states military forces2  2 and 
7,b7 by adding at the end the following3
  7#f7 ,military emergencies ,in the    
case of a determination described in    
paragraph 7#a77;,b71 the ,secretary     
shall determine1 within #de calendar    
days of such determination1 whether to  
make a declaration under paragraph 7#a71
 and1 if appropriate1 shall promptly    
make such a declaration4  2 and  7#b7 in
 subsection 7c7-- 7,a7 in paragraph     
7#c71 by striking 2 and and inserting 22
  7,b7 by redesignating paragraph 7#d7  
as paragraph 7#e72 and  7,c7 by         
inserting after paragraph 7#c7 the      
following3  7#d7 in the case of a       

determination described in subsection   
7b77#a77;,b77ii71 that the request for  
emergency use is made by the ,secretary 
of ,defense2 and  4  7b7 ,emergency uses
 for medical products  7#a7 ,in general 
,the ,secretary of ,defense may request 
that the ,secretary of ,health and      
,human ,services1 acting through the    
,commissioner of ,food and ,drugs1 take 
actions to expedite the development of a
 medical product1 review of             
investigational new drug applications   
under section #eje7;i7 of the ,federal  
,food1 ,drug1 and ,cosmetic ,act 7#ba   
,u4,s4,c4 #cee7;i771 review of          
investigational device exemptions under 
section #ebj7;g7 of such ,act 7#ba      
,u4,s4,c4 #cfj;j7g771 and review of     
applications for approval and clearance 
of medical products under sections #eje1
 #eaj7k71 and #eae of such ,act 7#ba    
,u4,s4,c4 #cee1 #cfj7k71 #cfj7;e77 and  
section #cea of the ,public ,health     
,service ,act 7#db ,u4,s4,c4 #bfb71     
including applications for licensing of 

vaccines or blood as biological products
 under such section #cea1 or            
applications for review of regenerative 
medicine advanced therapy products under
 section #ejf7;g7 of the ,federal ,food1
 ,drug1 and ,cosmetic ,act 7#ba         
,u4,s4,c4 #cef7;g771 if there is a      
military emergency1 or significant      
potential for a military emergency1     
involving a specific and imminently     
life-threatening risk to ,united ,states
 military forces of attack with an agent
 or agents1 and the medical product that
 is the subject of such application1    
submission1 or notification would be    
reasonably likely to diagnose1 prevent1 
treat1 or mitigate such life-threatening
 risk4  7#b7 ,actions ,upon a request by
 the ,secretary of ,defense under       
paragraph 7#a71 the ,secretary of       
,health and ,human ,services1 acting    
through the ,commissioner of ,food and  
,drugs1 shall take action to expedite   
the development and review of an        
applicable application or notification  

with respect to a medical product       
described in paragraph 7#a71 which may  
include1 as appropriate--  7,a7 holding 
meetings with the sponsor and the review
 team throughout the development of the 
medical product2  7,b7 providing timely 
advice to1 and interactive communication
 with1 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 practicable2  7,c7      
involving senior managers and           
experienced review staff1 as            
appropriate1 in a collaborative1        
cross-disciplinary review2  7,d7        
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 
sponsor2  7,e7 taking steps to ensure   
that the design of the clinical trials  
is as efficient as practicable1 when    

scientifically appropriate1 such as by  
minimizing the number of patients       
exposed to a potentially less           
efficacious treatment2  7,f7 applying   
any applicable ,food and ,drug          
,administration program intended to     
expedite the development and review of a
 medical product2 and  7,g7 in          
appropriate circumstances1 permitting   
expanded access to the medical product  
during the investigational phase1 in    
accordance with applicable requirements 
of the ,food and ,drug ,administration4 
7#c7 ,enhanced collaboration and        
communication ,in order to facilitate   
enhanced collaboration and communication
 with respect to the most current       
priorities of the ,department of        
,defense--  7,a7 the ,food and ,drug    
,administration shall meet with the     
,department of ,defense and any other   
appropriate development partners1 such  
as the ,biomedical ,advanced ,research  
and ,development ,authority1 on a       
semi-annual basis for the purposes of   

conducting a full review of the relevant
 products in the ,department of ,defense
 portfolio2 and  7,b7 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 therapy1 blood1 and   
vaccine medical products and projects   
that are the highest priorities to the  
,department of ,defense 7which may      
include freeze dried plasma products and
 platelet alternatives71  unless the    
,secretary of ,defense determines that  
any such meetings are not necessary4    
7#d7 ,medical product ,in this          
subsection1 the term medical product    
means a drug 7as defined in section #bja
 of the ,federal ,food1 ,drug1 and      
,cosmetic ,act 7#ba ,u4,s4,c4 #cba771 a 
device 7as defined in such section      
#bja71 or a biological product 7as      
defined in section #cea of the ,public  
,health ,service ,act 7#db ,u4,s4,c4    
#bfb774  7c7 ,repeal ,effective as of   

the enactment of the ,national ,defense 
,authorization ,act for ,fiscal ,year   
#bjah1 subsection 7d7 of section #aajg;a
 of title #aj1 ,united ,states ,code1 as
 added by section #gaf of the ,national 
,defense ,authorization ,act for ,fiscal
 ,year #bjah1 is repealed4  ,passed the 
,house of ,representatives ,november    
#ae1 #bjag4,karen ,l4 ,haas1,clerk