,,ii  #aah? ,,congress  #a/ ,session    
,s4 #adda  ,,9 ,,! ,,s5ate ,,( ,,!      
,,unit$ ,,/ates  ,may #d1 #bjbc,mr4     
,cornyn 7= himself & ,mr4 ,ka9e7        
introduc$ ! foll[+ bill2 :i* 0 read     
twice & ref]r$ to ! ,committee on       
,heal?1 ,education1 ,labor1 & ,p5sions  
,a ,,bill  ,to e/abli% a ,c5t] =        
,biom$ical ,innovation & ,developm5t 9  
ord] to accel]ate innovation &          
developm5t ( advanc$ m$ical c\nt]measure
 products4  #a4 ,%ort title ,?is ,act   
may be cit$ z ! ,accel]at+ ,biom$ical   
,innovation ,act4  #b4 ,c5t] = biom$ical
 innovation & developm5t program ,title 
,,iii ( ! ,public ,heal? ,s]vice ,act   
7#db ,u4,s4,c4 #bda et seq47 is am5d$ by
 ins]t+ aft] section #cai,l-#a ! foll[+3
  #cai,l-#b4 ,c5t] = biom$ical          
innovation & developm5t program  7a7    
,e/abli%m5t ( consortium ,n lat] ?an #a 
ye> aft] ! date ( enactm5t ( ?is        
section1 ! ,secret>y %all e/abli% a     
consortium ( n few] ?an #c in/itutions (
 high] education 7z def9$ 9 section #aja

 ( ! ,high] ,education ,act71 to        
accel]ate innovation & developm5t (     
advanc$ m$ical c\nt]measure products1   
includ+ biological products & devices1  
select$ by ! ,biom$ical ,advanc$ ,rese>*
 & ,developm5t ,ag5cy 7ref]r$ to 9 ?is  
section z ,,b>da74 ,su* consortium %all 
be kn[n z ! ,c5t] = ,biom$ical          
,innovation & ,developm5t 7ref]r$ to 9  
?is section z ! ,c5t]74  7b7 ,selection 
( p>ticipat+ in/itutions ,9 select+     
in/itutions ( high] education to        
p>ticipate 9 ! ,c5t] "u subsection 7a71 
! ,secret>y %all-- 7#a7 select eligible 
in/itutions t h-- 7,a7 exp]tise &       
capabilities 9 curr5t good manufactur+  
practices1 z def9$ 9 "p #aag ( title #ba
 ,code ( ,f$]al ,regulations 7or        
successor regulations72  7,b7 exp]i5ce 9
 te*nology innovation1 includ+ advanc$  
manufactur+ te*nologies1 t may assi/ 9  
c\nt]measure & advanc$ rese>* &         
developm5t2  7,c7 facilities ) flexible 
& adaptable advanc$ process developm5t  
capabilities2 &  7,d7 o!r relevant      

qualifications1 z det]m9$ by !          
,secret>y2  7#b7 select at lea/ "o      
in/itution ) ! capability to h&le secure
 & classifi$ in=mation1 z appropriate2 &
  7#c7 prioritize in/itutions mo/ likely
 to aid 9 ! advancem5t & innovation ( ! 
m$ical c\nt]measure products1 !         
manufactur+ processes = su* products1 & 
! execution & design ( cl9ical trials4  
7c7 ,c5t] activities ,! ,c5t] e/abli%$  
"u subsection 7a7 %all assi/ public &   
private entities 9 accel]at+ noncl9ical 
rese>* discov]ies ) respect to m$ical   
c\nt]measures ?r\gh advanc$ developm5t &
 cl9ical trials4 ,! activities ( ! ,c5t]
 may include-- 7#a7 advanc$ process     
developm5t & pilot manufactur+ to       
support cl9ical trials2  7#b7 te*nical  
assi/ance2  7#c7 contract aw>d          
managem5t2  7#d7 ref]ral & coord9ation )
 pot5tial manufactur+ p>tn]s2  7#e7     
regulatory assi/ance2  7#f7 te*nology   
transf]2 &  7#g7 program managem5t4  7d7
 ,eligible products ,a drug or device   
7includ+ a comb9ation ( "o or m drugs or

 devices7 is eligible = consid]ation &  
ref]ral by ! ,director ( ,,b>da to !    
,c5t] if su* drug or device incorporates
 a novel te*nology1 or uses an e/abli%$ 
te*nique or te*nology 9 a novel way1 t w
 sub/antially-- 7#a7 fur!r developm5t ( 
a drug or device ( int]e/2  7#b7 fulfil 
an unmet ne$2 or  7#c7 develop !        
manufactur+ process = a drug or device4 
7e7 ,int]national coord9ation ,!        
,director ( ,,b>da1 9 collaboration ) ! 
,assi/ant ,secret>y = ,global ,affairs &
 ! ,c5t] e/abli%$ "u subsection 7a71    
%all coord9ate1 z appropriate1 )        
int]national p>tn]s to enhance global   
heal? security by enc\rag+ o!r          
initiatives1 simil> to ! program        
describ$ 9 subsection 7a71 "u :i*       
int]national advanc$ developm5t networks
 support an exp&$ worldwide /rategy =   
vacc9e1 drug1 device1 & o!r c\nt]measure
 rese>*1 developm5t1 & manufactur+4  4