,i  #aai? ,,congress  #a/ ,session  ,h4 
,r4 #fjhi  ,,9 ,,! ,,h\se ,,(           
,,repres5tatives  ,novemb] #ah1         
#bjbe,ms4 ,h\lahan 7= h]self1 ,mr4      
,baird1 ,ms4 ,ross1 & ,mr4 ,r\z]7       
introduc$ ! foll[+ bill2 :i* 0 ref]r$ to
 ! ,committee on ,sci5ce1 ,space1 &     
,te*nology  ,a ,,bill  ,to e/abli% a    
,bioph>maceutical ,c5t] ( ,excell5ce1 & 
= o!r purposes4  #a4 ,%ort title ,?is   
,act may be cit$ z ! ,biomanufactur+    
,excell5ce ,act ( #bjbe4  #b4 ,f9d+s2   
s5se ( ,congress  7a7 ,f9d+s ,congress  
f9ds ! foll[+3  7#a7 ,biote*nology is ! 
design+ & eng9e]+ ( biological sy/ems4  
,biote*nology all[s sci5ti/s to gr[     
ev]y?+ f m$ic9es to crops to mat]ials1  
enabl+ biology by design4  7#b7         
,biote*nology holds ! pot5tial = !      
,unit$ ,/ates to trans=m its milit>y    
capabilities1 /r5g!n food security &    
agricultural resili5ce1 & cure          
life-?reat5+ diseases1 b x holds t same 
pot5tial = o!r c\ntries4 ,! c\ntries t  
ma/] biote*nology fir/ w ga9 ! ability  

to %ape h[ ^? te*nologies are us$ =     
decades to come4  7#c7 ,biote*nology    
unlocks ! capabilities ( produc+ m$ic9es
 via biological sy/ems1 kn[n z          
bioph>maceutical manufactur+4           
,bioph>maceutical manufactur+ w enable  
bett] & less invasive treatm5ts t ext5d 
& improve lives4  7#d7 ,by inve/+ 9     
biomanufactur+1 ! ,unit$ ,/ates         
,gov]nm5t w\ld r$uce dep5d5cy on =eign  
supply *a9s4  7#e7 ,= ,unit$ ,/ates     
manufactur]s1 ! bigge/ roadblock to     
comm]cialization is prov+ t _! products 
& processes c scale & produce a return  
on inve/m5t4 ,biomanufactur+ requires   
flexible & af=dable infra/ructure =     
developm5t1 to ensure t innovative      
products c rapidly move f ! lab to      
comm]cial-scale production4  7b7 ,s5se (
 ,congress ,x is ! s5se ( ,congress t-- 
7#a7 to realize ! pot5tial (            
biote*nology1 ! ,unit$ ,/ates ,gov]nm5t 
%\ld e/abli% a bioph>maceutical         
manufactur+ c5t] ( excell5ce2  7#b7 !   
c5t] %\ld facilitate & accel]ate        

manufactur+ innovation1 support good    
manufactur+ practices1 & provide =      
collaboration among public1 private1 &  
nonpr(it in/itutions2 &  7#c7 ! c5t]    
%\ld also facilitate tra9+ = work]s to  
op]ate biote*nology tools & equipm5t &  
to bol/] tal5t ?r\gh\t ! biote*nology   
sector4  #c4 ,e/abli%m5t ( ,national    
,bioph>maceutical ,c5t] ( ,excell5ce ,! 
,national ,in/itute ( ,/&>ds &          
,te*nology ,act 7#ae ,u4,s4,c4 #bga et  
seq47 is am5d$--  7#a7 by r$esignat+    
section #cf z section #cg2 &  7#b7 by   
ins]t+ aft] section #ce ! foll[+3  #cf4 
,national ,bioph>maceutical ,c5t] (     
,excell5ce  7a7 ,e/abli%m5t ( ,c5t] (   
,excell5ce  7#a7 ,9 g5]al ,! ,director  
%all aw>d a grant to or ent] into an o!r
 transaction agreem5t )1 on a           
competitive basis1 an eligible entity to
 e/abli% & op]ate a c5t] ( excell5ce to 
be kn[n z ! ,national ,bioph>maceutical 
,manufactur+ ,c5t] ( ,excell5ce 79 ?is  
section ref]r$ to z ! ,c5t] (           
,excell5ce74  7#b7 ,objectives ,!       

objectives ( ! ,c5t] ( ,excell5ce       
include--  7,a7 advanc+ ! sci5ce (      
bioph>maceutical manufactur+1 especially
 ) respect to products ( p>ticul>       
importance to ! national security1 heal?
 security1 or economic security ( !     
,unit$ ,/ates1 includ+ by-- 7i7 develop+
 & demon/rat+ flexible bioph>maceutical 
manufactur+ te*nologies & sy/ems2  7ii7 
improv+ up/ream & d[n/ream processes =  
multiple bioph>maceutical manufactur+   
plat=ms or product modalities2  7iii7   
improv+ bioph>maceutical manufactur+    
equipm5t & capabilities2 &  7iv7 r$uc+  
supply bottl5ecks & /r5g!n+ supply *a9  
self-suffici5cy ?r\gh demon/ration (    
innovative te*nologies2  7,b7 support+  
good manufactur+ practices1 quality by  
design1 & /&>dization ( *emi/ry1        
manufactur+1 & controls to ensure       
effective & effici5t manufactur+ & to   
improve ! regulation ( innovative me?ods
 ( manufactur+2  7,c7 advanc+ work=ce   
tra9+ & developm5t by work+ )           
educational & community p>tn]s to bol/] 

biote*nology tal5t2  7,d7 develop+ !    
sci5ce ( & deploy+ ! infra/ructure =    
innovative bioph>maceutical manufactur+ 
by engag+ )--  7i7 in/itutions ( high]  
education2  7ii7 small1 m$ium1 & l>ge   
ph>maceutical manufactur]s2  7iii7      
,f$]al1 ,/ate1 & local gov]nm5t ag5cies 
& in/itutes2  7iv7 non-pr(it            
organizations2  7v7 pr(essional         
organizations2 &  7vi7 any o!r entity ! 
,director consid]s relevant2  7,e7 %>+ )
 ! head ( any ,executive ag5cy t ov]sees
 ! plann+1 managem5t1 or coord9ation (  
,f$]al activities relat+ to biote*nology
 rese>* g5]at$ by ! ,c5t] ( ,excell5ce1 
includ+ data reg>d+ be/ practices =     
bioph>meceutical manufactur+2 &  7,f7   
any o!r objective ! ,director consid]s  
relevant4  7#c7 ,fund+ ,! ,director %all
 aw>d ! ,c5t] ( ,excell5ce fund+ = any (
 ! foll[+3 7,a7 ,to facilitate !        
con/ruction ( facilities necess>y to    
accompli% ! objectives describ$ 9       
p>agraph 7#b74  7,b7 ,to conduct        
collaborative rese>* on new te*nology = 

scal+ bioph>maceutical manufactur+ 9 !  
,unit$ ,/ates = comm]cial production4   
7,c7 ,to facilitate work=ce tra9+       
programs = bioph>maceutical manufactur+4
  7,d7 ,to fund relevant rese>* &       
programs = ! developm5t (               
bioph>maceutical manufactur+4  7b7      
,application2 aw>d  7#a7 ,9 g5]al ,n    
lat] ?an #ahj days aft] ! date ( !      
enactm5t ( ?is section1 ! ,director %all
 solicit applications f eligible        
entities specifi$ 9 p>agraph 7#b7 & aw>d
 to or ent] into ) "o su* entity a grant
 or o!r transaction agreem5t to e/abli% 
! ,c5t] ( ,excell5ce4  7#b7 ,eligibility
 ,an entity is eligible to submit an    
application pursuant to p>agraph 7#a7   
if-- 7,a7 ! entity is--  7i7 a          
public-private p>tn]%ip2  7ii7 an       
in/itution ( high] education2 or  7iii7 
a consortia ( entities specifi$ 9       
clauses 7i7 or 7ii72 &  7,b7 ! entity is
 n a ,f$]al entity4  7#c7 ,cont5t (     
application ,an application submitt$ by 
an entity pursuant to p>agraph 7#a7 %all

 include-- 7,a7 examples f ! entity (   
previ\s rese>*1 developm5t1             
implem5tation1 & demon/ration (         
innovative practices ( bioph>maceutical 
manufactur+2  7,b7 a description ( !    
mann] by :i* ! entity plans to advance !
 sci5ce ( bioph>maceutical manufactur+1 
especially ) respect to products (      
p>ticul> importance to ! national       
security1 heal? security1 or economic   
security ( ! ,unit$ ,/ates2  7,c7 a     
description ( ! mann] by :i* ! entity   
plans to incorporate good manufactur+   
practices1 quality by design1 &         
/&>dization ( *emi/ry1 manufactur+1 &   
controls1 & simil> guidance to ensure   
effective & effici5t manufactur+ & to   
make innovative me?ods ( manufactur+ m  
und]/&able to ,executive ag5cies t are  
task$ ) regulat+ su* me?ods2  7,d7      
examples ( tra9+s facilitat$ by ! entity
 t prep>e work]s = ! biote*nology       
sector2  7,e7 a description ( any exi/+ 
p>tn]%ips ) educational or community    
p>tn]s t help facilitate work=ce tra9+ =

 ! biote*nology sector2  7,f7 a         
description ( any exp]i5ce p>ticipat+ 9 
or lead+ bioph>maceutical manufactur+   
p>tn]%ips1 includ+ ^? ) in/itutions (   
high] education1 ph>maceutical          
manufactur]s1 non-pr(it organizations1 &
 gov]nm5tal ag5cies-- 7i7 to organize & 
conduct rese>* & developm5t aim$ at--   
7,i7 creat+ & /&>diz+ new & m effective 
te*nology2  7,,ii7 develop+ be/         
practices & %>+ k ab\t su* te*nology2   
7,,iii7 creat+ intellectual prop]ty2 &  
7,,iv7 ma9ta9+ te*nological lead]%ip 9 !
 ,unit$ ,/ates2  7ii7 to support !      
deploym5t ( innovative practices &      
infra/ructure ( bioph>maceutical        
manufactur+ 9 ! ,unit$ ,/ates2 &  7iii7 
to support develop+ a skill$ work=ce    
ready to use innovations 9 !            
bioph>maceutical manufactur+ sector2 &  
7,g7 a description ( h[ ! entity int5ds 
to utilize any funds au?oriz$ "u ?is    
section to build or exp& facilities &   
infra/ructure to a*ieve any ( !         
objectives describ$ 9 subsection        

7a77#b74  7#d7 ,selection ,crit]ia ,9   
select+ an applicant = a grant or o!r   
transaction agreem5t "u p>agraph 7#a71 !
 ,director %all consid] ! foll[+3  7,a7 
,! pot5tial ( ! applicant to e/abli% a  
,c5t] ( ,excell5ce t w\ld a*ieve !      
objectives set =? 9 subsection 7a77#b74 
7,b7 ,! pa/ p]=mance ( ! applicant 9    
bioph>maceutical manufactur+ work=ce    
developm5t & ! pot5tial ( ! applicant to
 support work=ce developm5t activities 9
 v>i\s regions ?r\gh\t ! ,unit$ ,/ates4 
7,c7 ,! ext5t to :i* ! applicant        
proposes to lev]age ! activities ( o!r  
bioph>maceutical manufactur+ innovation1
 developm5t1 & scal+ initiatives4  7,d7 
,:e!r ! propos$ location = ! ,c5t] (    
,excell5ce is proximate to o!r          
biomanufactur+ infra/ructure1 tra9+     
facilities1 or indu/rial clu/]s4  7,e7  
,! "t ! applicant e/imates is ne$$ = !  
,c5t] ( ,excell5ce to be fully          
op]ational & to />t deliv]+ impact4     
7,f7 ,! am\nt ( co-inve/m5t committ$ by 
,f$]al1 ,/ate1 private1 & o!r s\rces to 

e/abli% ! ,c5t] ( ,excell5ce4  7,g7 ,any
 additional crit]ia t ! ,director       
consid]s relevant4  7c7 ,annual reports 
7#a7 ,initial report ,n lat] ?an "o ye> 
aft] ! date on :i* ! ,director aw>ds to 
or ent]s into ) an eligible entity a    
grant or o!r transaction agreem5t to    
e/abli% ! ,c5t] ( ,excell5ce "u         
subsection 7b77#a71 ! ,director %all    
submit to ,congress a report describ+ ! 
progress on e/abli%+ ! ,c5t] (          
,excell5ce1 includ+--  7,a7 !           
con/ruction ( facilities2  7,b7 any     
activities1 p>tn]%ips1 & collaborations 
by ! ,c5t] ( ,excell5ce2 &  7,c7 any o!r
 in=mation reg>d+ ! =mation ( ! ,c5t] ( 
,excell5ce t ! ,director consid]s       
relevant4  7#b7 ,progress report ,n lat]
 ?an "o ye> aft] ! date on :i* op]ations
 at ! ,c5t] ( ,excell5ce (ficially beg91
 ! ,director %all submit to ,congress a 
report describ+--  7,a7 ! activities1   
p>tn]%ips1 collaborations1 & f9d+s ( !  
,c5t] ( ,excell5ce2 &  7,b7 any o!r     
in=mation reg>d+ ! ,c5t] ( ,excell5ce t 

! ,director consid]s relevant4  7#c7    
,f9al report ,n lat] ?an #e ye>s aft] ! 
date on :i* op]ations at ! ,c5t] (      
,excell5ce (ficially beg91 ! ,director  
%all submit to ,congress a report       
describ+-- 7,a7 ! activities1 p>tn]%ips1
 collaborations1 & f9d+s ( ! ,c5t] (    
,excell5ce2 &  7,b7 any o!r in=mation   
reg>d+ ! ,c5t] ( ,excell5ce t !         
,director consid]s relevant4  7#d7      
,publication ,! ,director %all make !   
reports requir$ by p>agraphs 7#a71 7#b71
 & 7#c7 available to ! public 9 an      
easily accessible electronic =mat on a  
website ( ! ,f$]al ,gov]nm5t t includes 
in=mation on biote*nology4  7d7         
,intellectual ,prop]ty ,! ,director %all
 ensure t1 prior to comm5c+ op]ations1 !
 ,c5t] ( ,excell5ce1 9 consultation )   
simil> exi/+ in/itutions1 su* z         
,manufactur+ ,,usa in/itutes 7z def9$ 9 
section #cd7;d771 e/abli%es intellectual
 prop]ty guidel9es = rese>* conduct$ )9 
or 9 collaboration ) ! ,c5t] (          
,excell5ce4  7e7 ,au?orization (        

,appropriations ,!re is au?oriz$ to be  
appropriat$ to ! ,director to c>ry out  
?is section #abj1jjj1jjj = fiscal ye>   
#bjbf4  7f7 ,def9itions ,9 ?is section3 
7#a7 ,biomanufactur+ ,! t]m             
biomanufactur+ means ! application (    
biote*nology to manufactur+4  7#b7      
,bioph>maceutical ,! t]m                
bioph>maceutical means a ph>maceutical  
drug product manufactur$ us+1 extract$  
f1 or syn!siz$ f liv+ cells or          
biological organisms4  7#c7             
,biote*nology ,! t]m biote*nology means 
! application ( sci5ce or eng9e]+1      
directly or indirectly1 to--  7,a7 a    
liv+ organism2  7,b7 a "p or product ( a
 liv+ organism2 or  7,c7 a modifi$ =m ( 
subp>agraph 7,a7 or 7,b74  7#d7         
,executive ag5cy ,! t]m ,executive      
ag5cy--  7,a7 has ! mean+ giv5 t t]m 9  
section #aje ( title #e1 ,unit$ ,/ates  
,code2 &  7,b7 includes ! ,executive    
,(fice ( ! ,presid5t & ! ,(fice ( !     
,vice ,presid5t4  7#e7 ,in/itution (    
high] education ,! t]m in/itution (     

high] education has ! mean+ giv5 t t]m 9
 section #aja ( ! ,high] ,education ,act
 ( #aife 7#bj ,u4,s4,c4 #ajja74  4