,i  #aag? ,,congress  #b;d ,session  ,h4
 ,r4 #fihh  ,,9 ,,! ,,h\se ,,(          
,,repres5tatives  ,m>* #h1 #bjbb,mr4    
,lev9 ( ,cali=nia 7= himself & ,mr4     
,joyce ( ,p5nsylvania7 introduc$ !      
foll[+ bill2 :i* 0 ref]r$ to !          
,committee on ,en]gy & ,comm]ce  ,a     
,,bill  ,to am5d ! ,f$]al ,food1 ,drug1 
& ,cosmetic ,act to au?orize a program  
to support ! adoption (1 & improve !    
developm5t (1 innovative approa*es to   
ph>maceutical product design &          
manufactur+1 & = o!r purposes4  #a4     
,%ort title ,?is ,act may be cit$ z !   
,drug ,manufactur+ ,innovation ,act (   
#bjbb4  #b4 ,em]g+ te*nology program    
,*apt] ,v ( ! ,f$]al ,food1 ,drug1 &    
,cosmetic ,act 7#ba ,u4,s4,c4 #bja et   
seq47 is am5d$ by ins]t+ aft] section   
#eff ( su* ,act 7#ba ,u4,s4,c4          
#cfj;bbb-#e7 ! foll[+3  #eff;,a4 ,em]g+ 
te*nology program  7a7 ,program         
e/abli%m5t  7#a7 ,9 g5]al ,! ,secret>y  
%all e/abli% a program to support !     
adoption (1 & improve ! developm5t (1   

innovative approa*es to ph>maceutical   
product design & manufactur+4  7#b7     
,actions ,9 c>ry+ out ! program "u      
p>agraph 7#a71 ! ,secret>y may-- 7,a7   
facilitate & increase communication     
betwe5 public & private entities1       
consortia1 & individuals ) respect to   
innovative ph>maceutical product design 
& manufactur+2  7,b7 solicit in=mation  
reg>d+1 & conduct or support rese>* on1 
innovative approa*es to ph>maceutical   
product design & manufactur+2  7,c7     
conv5e meet+s ) repres5tatives (        
indu/ry1 academia1 o!r ,f$]al ag5cies1  
int]national ag5cies1 & o!r int]e/$     
p]sons1 z appropriate2  7,d7 conv5e     
work+ gr\ps to support ph>maceutical    
product design & manufactur+ rese>* &   
developm5t2  7,e7 support education &   
tra9+ = regulatory /aff & sci5ti/s      
relat$ to innovative approa*es to       
ph>maceutical product design &          
manufactur+2  7,f7 conduct rese>* & te/+
 to develop or validate innovative      
approa*es to ph>maceutical product      

design & manufactur+2  7,g7 advance     
regulatory sci5ce relat$ to ! developm5t
 & review ( innovative approa*es to     
ph>maceutical product design &          
manufactur+2  7,h7 conv5e work+ gr\ps to
 support ! h>monization ( int]national  
regulatory requirem5ts relat$ to        
innovative approa*es to ph>maceutical   
product design & manufactur+2 &  7,i7   
aw>d grants or contracts to c>ry out or 
support ! program "u p>agraph 7#a74     
7#c7 ,grants & contracts ,to seek a     
grant or contract "u ?is section1 an    
entity %all submit an application-- 7,a7
 9 su* =m & mann] z ! ,secret>y may     
require2 &  7,b7 conta9+ su* in=mation z
 ! ,secret>y may require1 includ+ a     
description (-- 7i7 h[ ! entity w       
conduct ! activities to be support$     
?r\gh ! grant or contract2 &  7ii7 h[   
su* activities w fur!r rese>* &         
developm5t relat$ to1 or adoption (1    
innovative approa*es to ph>maceutical   
product design & manufactur+4  7b7      
,guidance ,! ,secret>y %all-- 7#a7 issue

 or update guidance to help facilitate !
 adoption (1 & advance ! developm5t (1  
innovative approa*es to ph>maceutical   
product design & manufactur+2 &  7#b7   
include 9 su* guidance descriptions (-- 
7,a7 any regulatory requirem5ts relat$  
to ! developm5t or review ( te*nologies 
relat$ to innovative approa*es to       
ph>maceutical product design &          
manufactur+1 includ+ regulatory         
requirem5ts necess>y = updates &        
improvem5ts to su* te*nologies aft]     
product approval2 &  7,b7 data requir$  
to demon/rate ! id5tity1 safety1 purity1
 & pot5cy ( drugs manufactur$ us+ su*   
te*nologies4  7c7 ,report to ,congress  
,n lat] ?an #d ye>s aft] ! date (       
enactm5t ( ?is section1 ! ,secret>y %all
 submit to ! ,committee on ,en]gy &     
,comm]ce ( ! ,h\se ( ,repres5tatives & !
 ,committee on ,heal?1 ,education1      
,labor1 & ,p5sions ( ! ,s5ate a report  
conta9+-- 7#a7 an annual acc\nt+ ( !    
allocation ( funds made available to    
c>ry out ?is section2  7#b7 ! numb] (   

full-"t equival5t /aff d$icat$ to !     
program "u subsection 7a77#a72  7#c7 !  
numb] ( meet+s held by ! ,food & ,drug  
,adm9i/ration1 includ+ meet+s conv5$ z  
"p ( a work+ gr\p describ$ 9 subp>agraph
 7,d7 or 7,h7 ( p>agraph 7#b7 (         
subsection 7a71 & ! topics ( ea* su*    
meet+2 &  7#d7 ! numb] ( products       
approv$ or lic5s$1 aft] ! date (        
enactm5t ( ?is section1 us+ an          
innovative approa* to ph>maceutical     
product design & manufactur+4  7d7      
,au?orization ( appropriations ,to c>ry 
out ?is section1 !re is au?oriz$ to be  
appropriat$ #bj1jjj1jjj = ea* fiscal ye>
 #bjbc ?r\gh #bjbg4  4