,,ii  #aai? ,,congress  #a/ ,session    
,s4 #ceaj  ,,9 ,,! ,,s5ate ,,( ,,!      
,,unit$ ,,/ates  ,decemb] #af1 #bjbe,mr4
 ,budd 7= himself & ,ms4 ,hassan7       
introduc$ ! foll[+ bill2 :i* 0 read     
twice & ref]r$ to ! ,committee on       
,heal?1 ,education1 ,labor1 & ,p5sions  
,a ,,bill  ,to improve ! inspections (  
drug e/abli%m5ts engag$ 9 ! manufacture1
 prep>ation1 propagation1 or process+ ( 
biosimil> biological products conduct$  
by ! ,food & ,drug ,adm9i/ration1 & =   
o!r purposes4  #a4 ,%ort title ,?is ,act
 may be cit$ z ! ,biosimil> ,inspection 
,mod]nization ,act ( #bjbe4  #b4        
,def9itions ,9 ?is ,act-- 7#a7 ! t]m    
biosimil> biological product means a    
biological product lic5s$ "u section    
#cea7k7 ( ! ,public ,heal? ,s]vice ,act 
7#db ,u4,s4,c4 #bfb7k772  7#b7 ! t]m    
biosimil> biological product e/abli%m5t 
means an e/abli%m5t engag$ 9 !          
manufacture1 prep>ation1 propagation1 or
 process+ ( a biosimil> biological      
product & regi/]$ "u subsection 7b77#a71

 7c77#a71 or 7i7 ( section #eaj ( !     
,f$]al ,food1 ,drug1 & ,cosmetic ,act   
7#ba ,u4,s4,c4 #cfj72 &  7#c7 ! t]m     
,secret>y means ! ,secret>y ( ,heal? &  
,human ,s]vices1 act+ ?r\gh !           
,commission] ( ,food & ,drugs4  #c4     
,public meet+ & report on mutual        
recognition agreem5ts  7a7 ,public meet+
 ,n lat] ?an #ahj days aft] ! date (    
enactm5t ( ?is ,act1 ! ,secret>y %all   
conduct a public meet+ on ! use ( mutual
 recognition agreem5ts = purposes (     
c>ry+ out inspections "u section #gjd ( 
! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 
7#ba ,u4,s4,c4 #cgd7 ( e/abli%m5ts      
engag$ 9 ! manufacture1 prep>ation1     
propagation1 or process+ ( a biosimil>  
biological product1 includ+ a discussion
 (-- 7#a7 h[ mutual recognition         
agreem5ts are utiliz$ ) respect to !    
inspection ( biosimil> biological       
product e/abli%m5ts1 & areas =          
improvem5ts 9 su* inspections conduct$  
pursuant to su* agreem5ts2 &  7#b7 areas
 9 :i* use ( mutual recognition         

agreem5ts c\ld be exp&$ to apply beyond 
compliance inspections "u section #gjd (
 ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act
 7#ba ,u4,s4,c4 #cgd71 includ+ = use 9  
conjunction ) remote regulatory         
assessm5ts1 inspections conduct$ by     
tru/$ =eign p>tn]s id5tifi$ by ! ,food &
 ,drug ,adm9i/ration1 & virtual         
int]actions ) subject matt] exp]ts4  7b7
 ,report ,n lat] ?an #ahj days aft] !   
public meet+ "u subsection 7a7 is       
conduct$1 ! ,secret>y %all issue to !   
,committee on ,heal?1 ,education1       
,labor1 & ,p5sions ( ! ,s5ate & !       
,committee on ,en]gy & ,comm]ce ( !     
,h\se ( ,repres5tatives1 & make publicly
 available1 a report t includes         
recomm5dations on ! use ( mutual        
recognition agreem5ts = purposes (      
conduct+ inspections ( biosimil>        
biological product e/abli%m5ts4  #d4    
,ensur+ flexibility 9 inspection tools  
,! ,secret>y %all update inspection     
processes & exi/+ tools to advance a    
risk-bas$ approa* to evaluate1 includ+  

conduct+ inspections1 ( e/abli%m5ts     
engag$ 9 ! manufacture1 prep>ation1     
propagation1 or process+ ( biosimil>    
biological products to enable ! ,food & 
,drug ,adm9i/ration to-- 7#a7 increase  
utilization ( remote regulatory         
assessm5ts "u section #gjd ( ! ,f$]al   
,food1 ,drug1 & ,cosmetic ,act 7#ba     
,u4,s4,c4 #cgd71 9 accordance ) !       
guidance issu$ by ! ,food & ,drug       
,adm9i/ration1 titl$ ,conduct+ ,remote  
,regulatory ,assessm5ts--,que/ions &    
,answ]s 7,june #bd1 #bjbe7 7or any      
successor guidance72 &  7#b7 maximize ! 
use ( alt]native tools set =? 9 !       
guidance describ$ 9 p>agraph 7#a7 to    
improve inspection effici5cy4  #e4 ,,fda
 /rategic plan on dome/ic inspection    
improvem5ts = biosimil> biological      
facilities ,n lat] ?an #a ye> aft] !    
date ( enactm5t ( ?is ,act1 ! ,secret>y 
%all develop & publi% a /rategic plan on
 ways ! ,food & ,drug ,adm9i/ration w   
address *all5ges ) respect to !         
inspection ( dome/ic biosimil>          

biological product e/abli%m5ts1 includ+ 
reg>d+-- 7#a7 recruit+ & reta9+         
inspections /aff2  7#b7 *all5ges        
specific to inspect+ dome/ic biosimil>  
biological product e/abli%m5ts2  7#c7   
improv+ int]nal communication among all 
,food & ,drug ,adm9i/ration p]sonnel    
involv$ 9 inspections ( biosimil>       
biological product e/abli%m5ts2 &  7#d7 
exp&+ opportunities = ext]nal           
communications ) sponsors ( applications
 "u section #cea7k7 ( ! ,public ,heal?  
,s]vice ,act 7#db ,u4,s4,c4 #bfb7k771   
includ+ in=m+ su* sponsors ab\t pot5tial
 inspection requirem5ts & resolv+ out/&+
 inspection relat$ que/ions e>li] 9 !   
review process4