,,ii  #aag? ,,congress  #a/ ,session    
,s4 #behi  ,,9 ,,! ,,s5ate ,,( ,,!      
,,unit$ ,,/ates  ,augu/ #c1 #bjba,mrs4  
,blackburn 7= h]self & ,mr4 ,m55dez7    
introduc$ ! foll[+ bill2 :i* 0 read     
twice & ref]r$ to ! ,committee on       
,heal?1 ,education1 ,labor1 & ,p5sions  
,a ,,bill  ,to am5d ! #ba/ ,c5tury      
,cures ,act to provide = designation (  
in/itutions ( high] education t provide 
rese>*1 data1 & lead]%ip on advanc$ &   
cont9u\s manufactur+ z ,national ,c5t]s 
( ,excell5ce 9 ,cont9u\s ,ph>maceutical 
,manufactur+1 & = o!r purposes4  #a4    
,%ort title ,?is ,act may be cit$ z !   
,secur+ ,am]ica's ,m$ic9e ,cab9et ,act (
 #bjba4  #b4 ,national ,c5t]s (         
,excell5ce 9 ,advanc$ & ,cont9u\s       
,ph>maceutical ,manufactur+  7a7 ,9     
g5]al ,section #cjaf ( ! #ba/ ,c5tury   
,cures ,act 7#ba ,u4,s4,c4 #cii;h7 is   
am5d$ to read z foll[s3  #cjaf4         
,national ,c5t]s ( ,excell5ce 9 ,advanc$
 & ,cont9u\s ,ph>maceutical ,manufactur+
  7a7 ,9 g5]al ,! ,secret>y ( ,heal? &  

,human ,s]vices1 act+ ?r\gh !           
,commission] ( ,food & ,drugs-- 7#a7    
%all solicit &1 beg9n+ n lat] ?an "o ye>
 aft] ! date ( enactm5t ( ! ,secur+     
,am]ica's ,m$ic9e ,cab9et ,act ( #bjba1 
receive reque/s f in/itutions ( high]   
education1 or consortia ( in/itutions ( 
high] education1 to be designat$ z a    
,national ,c5t] ( ,excell5ce 9 ,advanc$ 
& ,cont9u\s ,ph>maceutical ,manufactur+ 
79 ?is section ref]r$ to z a ,national  
,c5t] ( ,excell5ce7 to support !        
advancem5t1 developm5t1 & implem5tation 
( advanc$ & cont9u\s ph>maceutical      
manufactur+2 &  7#b7 %all s designate n 
m ?an #e in/itutions ( high] education  
or consortia ( su* in/itutions t-- 7,a7 
reque/ su* designation2 &  7,b7 meet !  
crit]ia specifi$ 9 subsection 7c74  7b7 
,reque/ = designation ,a reque/ =       
designation "u subsection 7a7 %all be   
made to ! ,secret>y at su* "t1 9 su*    
mann]1 & conta9+ su* in=mation z !      
,secret>y may require4 ,any su* reque/  
%all include a description ( h[ !       

in/itution ( high] education1 or        
consortium ( in/itutions ( high]        
education1 meets or plans to meet ea* ( 
! crit]ia specifi$ 9 subsection 7c74    
7c7 ,crit]ia = designation describ$ ,!  
crit]ia specifi$ 9 ?is subsection )     
respect to an in/itution ( high]        
education1 or consortium ( in/itutions (
 high] education1 are t ! in/itution or 
consortium has1 z ( ! date ( !          
submission ( a reque/ "u subsection 7a7 
by su* in/itution or consortium-- 7#a7  
physical & te*nical capacity = rese>*1  
developm5t1 implem5tation1 &            
demon/ration ( advanc$ & cont9u\s       
ph>maceutical manufactur+2  7#b7        
manufactur+ k-%>+ networks ) o!r        
in/itutions ( high] education1 l>ge &   
small ph>maceutical manufactur]s1 g5]ic 
& nonprescription manufactur]s1 contract
 manufactur]s1 & o!r relevant entities2 
7#c7 prov5 capacity to design1 develop1 
implem5t1 & demon/rate new1 highly      
effective te*nologies = use 9 advanc$ & 
cont9u\s ph>maceutical manufactur+2     

7#d7 a track record = creat+1 pres]v+1 &
 transf]r+ k ) respect to advanc$ &     
cont9u\s ph>maceutical manufactur+2     
7#e7 ! prov5 ability to facilitate tra9+
 ( an adequate future work=ce = rese>*  
on1 & implem5tation (1 advanc$ &        
cont9u\s ph>maceutical manufactur+2 &   
7#f7 exp]i5ce 9 p>ticipat+ 9 & lead+    
advanc$ & cont9u\s ph>maceutical        
manufactur+ te*nology p>tn]%ips ) o!r   
in/itutions ( high] education1 l>ge &   
small ph>maceutical manufactur]s1 g5]ic 
& nonprescription manufactur]s1 contract
 manufactur]s1 & o!r relevant entities--
 7,a7 to support companies seek+ to     
implem5t advanc$ & cont9u\s             
ph>maceutical manufactur+ 9 ! ,unit$    
,/ates2  7,b7 to support ,f$]al ag5cies 
) te*nical assi/ance & employee tra9+1  
:i* may include regulatory & quality    
metric guidance z applicable1 & h&s-on  
tra9+1 = advanc$ & cont9u\s             
ph>maceutical manufactur+2  7,c7 )      
respect to advanc$ & cont9u\s           
ph>maceutical manufactur+1 to organize &

 conduct rese>* & developm5t activities 
ne$$ to create new & m effective        
te*nology1 develop & %>e k1 create      
intellectual prop]ty1 & ma9ta9          
te*nological lead]%ip2  7,d7 to develop 
be/ practices = design+ & implem5t+     
advanc$ & cont9u\s ph>maceutical        
manufactur+ processes2 &  7,e7 to assess
 & respond to ! national work=ce ne$s = 
advanc$ & cont9u\s ph>maceutical        
manufactur+1 includ+ ! developm5t &     
implem5t+ ( tra9+ programs4  7d7        
,t]m9ation ( designation ,! ,secret>y   
may t]m9ate ! designation ( any         
,national ,c5t] ( ,excell5ce designat$  
"u ?is section if ! ,secret>y det]m9es  
su* ,national ,c5t] ( ,excell5ce no     
long] meets ! crit]ia specifi$ 9        
subsection 7c74 ,n lat] ?an #ij days    
be=e ! effective date ( su* a t]m9ation1
 ! ,secret>y %all provide writt5 notice 
to ! ,national ,c5t] ( ,excell5ce1      
includ+ ! rationale = su* t]m9ation4    
7e7 ,conditions = designation ,z a      
condition ( designation z a ,national   

,c5t] ( ,excell5ce "u ?is section1 !    
,secret>y %all require t an in/itution (
 high] education or consortium (        
in/itutions ( high] education ent]s into
 an agreem5t ) ! ,secret>y "u :i* !     
in/itution or consortium agrees-- 7#a7  
to collaborate directly ) ! ,food &     
,drug ,adm9i/ration to publi% ! reports 
requir$ by subsection 7g72  7#b7 to %>e 
data ) ! ,food & ,drug ,adm9i/ration    
reg>d+ be/ practices & rese>* g5]at$    
?r\gh ! fund+ "u subsection 7f72  7#c7  
to develop1 along ) indu/ry p>tn]s 7:i* 
may include l>ge & small                
bioph>maceutical manufactur]s1 g5]ic &  
nonprescription manufactur]s1 & contract
 rese>* organizations or contract       
manufactur]s t c>ry out drug developm5t 
& manufactur+ activities7 & ano!r       
in/itution or consortium designat$ "u   
?is section1 if any1 a roadmap =        
develop+ an advanc$ & cont9u\s          
ph>maceutical manufactur+ work=ce2  7#d7
 to develop1 along ) indu/ry p>tn]s &   
o!r in/itutions or consortia ( su*      

in/itutions designat$ "u ?is section1 a 
roadmap = /r5g!n+ exi/+1 & develop+ new1
 relation%ips ) o!r in/itutions ( high] 
education or consortia !re(2 &  7#e7 to 
provide an annual report to ! ,food &   
,drug ,adm9i/ration reg>d+ !            
in/itution's or consortium's activities 
"u ?is section1 includ+ a description ( 
h[ ! in/itution or consortium cont9ues  
to meet & make progress on ! crit]ia    
specifi$ 9 subsection 7c74  7f7 ,fund+  
7#a7 ,9 g5]al ,! ,secret>y %all aw>d    
fund+1 ?r\gh grants1 contracts1 or      
coop]ative agreem5ts1 to ! ,national    
,c5t]s ( ,excell5ce designat$ "u ?is    
section = ! purpose ( /udy+ & recomm5d+ 
improvem5ts to advanc$ & cont9u\s       
ph>maceutical manufactur+1 includ+ su*  
improvem5ts z may enable ! ,c5t]s-- 7,a7
 to cont9ue to meet ! conditions        
specifi$ 9 subsection 7e72  7,b7 to exp&
 capacity = rese>* on1 & developm5t (1  
advanc$ & cont9u\s ph>maceutical        
manufactur+2 &  7,c7 to implem5t rese>* 
infra/ructure 9 advanc$ & cont9u\s      

ph>maceutical manufactur+ suitable =    
accel]at+ ! developm5t ( drug products  
ne$$ to respond to em]g+ m$ical ?reats1 
su* z em]g+ drug %ortages1 quality      
issues disrupt+ ! supply *a91 epidemics 
& p&emics1 & o!r su* situations requir+ 
! rapid developm5t ( new products or new
 manufactur+ processes4  7#b7 ,consi/5cy
 ) ,,fda mission ,z a condition on      
receipt ( fund+ "u ?is subsection1 a    
,national ,c5t] ( ,excell5ce %all agree 
to consid] any input f ! ,secret>y      
reg>d+ ! use ( fund+ t w\ld-- 7,a7 help 
to fur!r ! advancem5t ( advanc$ &       
cont9u\s ph>maceutical manufactur+ ?r\gh
 ! ,national ,c5t] ( ,excell5ce2 &  7,b7
 be relevant to ! mission ( ! ,food &   
,drug ,adm9i/ration4  7#c7 ,au?orization
 ( appropriations ,!re is au?oriz$ to be
 appropriat$ to c>ry out ?is subsection 
#hj1jjj1jjj = ! p]iod ( fiscal ye>s     
#bjbb ?r\gh #bjbf4  7#d7 ,rule (        
con/ruction ,no?+ 9 ?is section %all be 
con/ru$ z preclud+ a ,national ,c5t] =  
,excell5ce designat$ "u ?is section f   

receiv+ funds "u any o!r provision ( ?is
 ,act or any o!r ,f$]al law4  7g7       
,annual review & reports  7#a7 ,annual  
report ,beg9n+ n lat] ?an "o ye> aft] ! 
date on :i* ! fir/ designation is made  
"u subsection 7a71 & annually !reaft]1 !
 ,secret>y %all-- 7,a7 submit to        
,congress a report describ+ !           
activities1 p>tn]%ips & collaborations1 
,f$]al policy recomm5dations1 previ\s & 
cont9u+ fund+1 & f9d+s (1 & any o!r     
applicable in=mation f1 ! ,national     
,c5t]s ( ,excell5ce designat$ "u ?is    
section2 &  7,b7 make su* report        
available to ! public 9 an easily       
accessible electronic =mat on ! website 
( ! ,food & ,drug ,adm9i/ration4  7#b7  
,review ( ,national ,c5t]s ( ,excell5ce 
& pot5tial designees ,! ,secret>y %all  
p]iodically review ! ,national ,c5t]s ( 
,excell5ce designat$ "u ?is section to  
ensure t su* ,national ,c5t]s (         
,excell5ce cont9ue to meet ! crit]ia =  
designation "u ?is section4  7#c7       
,report on long-t]m vision ( ,,fda role 

,n lat] ?an #b ye>s aft] ! date on :i* !
 fir/ designation is made "u subsection 
7a71 ! ,secret>y1 9 consultation ) !    
,national ,c5t]s ( ,excell5ce designat$ 
"u ?is section1 %all submit a report to 
,congress on ! long-t]m vision ( !      
,dep>tm5t ( ,heal? & ,human ,s]vices on 
! role ( ! ,food & ,drug ,adm9i/ration 9
 support+ advanc$ & cont9u\s            
ph>maceutical manufactur+1 includ+--    
7,a7 a national framework ( pr9ciples   
relat$ to ! implem5tation & regulation (
 advanc$ & cont9u\s ph>maceutical       
manufactur+2  7,b7 a plan = ! developm5t
 ( ,f$]al regulations & guidance = h[   
advanc$ & cont9u\s ph>maceutical        
manufactur+ c be incorporat$ into !     
developm5t ( ph>maceuticals & regulatory
 responsibilities ( ! ,food & ,drug     
,adm9i/ration2  7,c7 a plan = developm5t
 ( ,f$]al regulations or guidance = h[  
advanc$ & cont9u\s ph>maceutical        
manufactur+ w be review$ by ! ,food &   
,drug ,adm9i/ration2 &  7,d7 appropriate
 fe$back solicit$ f ! public1 :i* may   

include o!r in/itutions ( high]         
education1 l>ge & small bioph>maceutical
 manufactur]s1 g5]ic & nonprescription  
manufactur]s1 & contract manufactur]s4  
7h7 ,def9itions ,9 ?is section3 7#a7    
,advanc$ ,! t]m advanc$1 ) respect to   
ph>maceutical manufactur+1 ref]s to an  
approa* t incorporates novel te*nology1 
or uses an e/abli%$ te*nique or         
te*nology 9 a new or innovative way1 t  
enhances drug quality or improves !     
p]=mance ( a manufactur+ process4  7#b7 
,cont9u\s ,! t]m cont9u\s1 ) respect to 
ph>maceutical manufactur+1 ref]s to a   
process-- 7,a7 :]e ! input mat]ials are 
cont9u\sly f$ into & trans=m$ )9 !      
process1 & ! process$ output mat]ials   
are cont9u\sly remov$ f ! sy/em2 &  7,b7
 t consi/s ( an integrat$ process t     
consi/s ( a s]ies ( two or m simultane\s
 unit op]ations4  7#c7 ,in/itution (    
high] education ,! t]m in/itution (     
high] education has ! mean+ giv5 su* t]m
 9 section #aja7;a7 ( ! ,high]          
,education ,act ( #aife 7#bj ,u4,s4,c4  

#ajja7;a774  7#d7 ,secret>y ,! t]m      
,secret>y means ! ,secret>y ( ,heal? &  
,human ,s]vices1 act+ ?r\gh !           
,commission] ( ,food & ,drugs4  4  7b7  
,transition rule ,section #cjaf ( ! #ba/
 ,c5tury ,cures ,act 7#ba ,u4,s4,c4     
#cii;h71 z 9 effect on ! day be=e ! date
 ( ! enactm5t ( ?is section1 %all apply 
) respect to grants aw>d$ "u su* section
 be=e su* date ( enactm5t4