,,ii  #aahth ,,congress  #ast ,session  
,s4 #bcbi  ,,in ,,the ,,senate ,,of     
,,the ,,united ,,states  ,july #ac1     
#bjbc,mr4 ,hickenlooper 7for himself and
 ,mr4 ,budd7 introduced the following   
bill2 which was read twice and referred 
to the ,committee on ,health1           
,education1 ,labor1 and ,pensions  ,a   
,,bill  ,to establish an emerging       
pathogen preparedness program within the
 ,food and ,drug ,administration to     
improve regulatory oversight of medical 
countermeasures for future pandemics4   
#a4 ,short title ,this ,act may be cited
 as the ,emerging ,pathogen             
,preparedness ,program ,authorization   
,act4  #b4 ,emerging pathogens          
preparedness program  7a7 ,in general   
,section #efe of the ,federal ,food1    
,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4
 #cfj;bbb-#d7 is amended by adding at   
the end the following3  7j7 ,emerging   
pathogens preparedness program  7#a7 ,in
 general ,the ,secretary shall establish
 a program to facilitate the            

development1 review1 licensure1         
approval1 and clearance of              
countermeasures1 and products that could
 potentially be countermeasures1 under  
the jurisdiction of the ,center for     
,biologics ,evaluation and ,research4   
7#b7 ,activities ,the activities of the 
program established under paragraph 7#a7
 may include1 either directly or by     
grant1 contract1 or cooperative         
agreement1 the following3 7,a7 ,any     
activities described in subsection 7b74 
7,b7 ,activities to advance scientific  
research related to the development of  
tools1 standards1 and approaches to     
assess the safety1 efficacy1 quality1   
and performance of countermeasures4     
7,c7 ,activities to maintain or enhance 
surveillance programs that monitor      
countermeasures4  7,d7 ,activities to   
help ensure blood safety and            
availability4  7,e7 ,prioritizing the   
research and development of platform    
vaccine technologies to support an      
emergency use authorization request     

under section #efd or an application    
under #cea7;a7 of the ,public ,health   
,service ,act4  7,f7 ,such other        
activities as the ,secretary determines 
necessary or appropriate4  7#c7 ,rule of
 construction ,nothing in this          
subsection shall be construed to alter  
the authority of the ,secretary to      
license1 approve1 clear1 or authorize   
countermeasures1 including biological   
products1 pursuant to section #cea of   
the ,public ,health ,service ,act or    
section #eje or #efd of this ,act1      
including standards of evidence and     
applicable conditions for licensure1    
approval1 clearance1 or authorization4  
4  7b7 ,authorization of appropriations 
,to carry out subsection 7j7 of section 
#efe of the ,federal ,food1 ,drug1 and  
,cosmetic ,act 7#ba ,u4,s4,c4           
#cfj;bbb-#d71 as added by subsection    
7a71 there is authorized to be          
appropriated #fj1jjj1jjj for each of    
fiscal years #bjbd through #bjbh4