,i  #aag? ,,congress  #b;d ,session  ,h4
 ,r4 #gjjf  ,,9 ,,! ,,h\se ,,(          
,,repres5tatives  ,m>* #i1 #bjbb,mr4    
,griffi? 7= himself & ,mr4 ,wel*7       
introduc$ ! foll[+ bill2 :i* 0 ref]r$ to
 ! ,committee on ,en]gy & ,comm]ce  ,a  
,,bill  ,to am5d ! ,f$]al ,food1 ,drug1 
& ,cosmetic ,act to improve inspections 
( =eign drug manufactur+ e/abli%m5ts1 & 
= o!r purposes4  #a4 ,%ort title ,?is   
,act may be cit$ z ! ,improv+ !         
,nation's ,safe ,ph>maceuticals &       
,excipi5ts by ,creat+ ,tools = ,inspect+
 & ,ov]see+ ,ne$$ ,supplies ,act or !   
,,inspections ,act4  #b4 ,improv+ ,,fda 
inspections  7a7 ,risk factors =        
e/abli%m5ts ,section #eaj7;h77#d7 ( !   
,f$]al ,food1 ,drug1 & ,cosmetic ,act   
7#ba ,u4,s4,c4 #cfj7;h77#d77 is am5d$-- 
7#a7 by r$esignat+ subp>agraph 7,f7 z   
subp>agraph 7,g72 &  7#b7 by ins]t+ aft]
 subp>agraph 7,e7 ! foll[+3  7,f7 ,!    
compliance hi/ory ( e/abli%m5ts 9 !     
c\ntry or region 9 :i* ! e/abli%m5t is  
locat$ t are subject to regulation "u   

?is ,act1 includ+ ! hi/ory ( violations 
relat$ to products export$ f su* c\ntry 
or region t are subject to su*          
regulation4  4  7b7 ,use ( records      
,section #gjd7;a77#d7 ( ! ,f$]al ,food1 
,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4  
#cgd7 is am5d$-- 7#a7 by r$esignat+     
subp>agraph 7,c7 z subp>agraph 7,d72 &  
7#b7 by ins]t+ aft] subp>agraph 7,b7 !  
foll[+3  7,c7 ,! ,secret>y may use any  
records or o!r in=mation t ! ,secret>y  
may inspect "u ?is section to satisfy   
requirem5ts = a preapproval or risk-bas$
 surveillance inspection1 includ+       
resolv+ ! f9d+s ( su* inspections1 if   
applicable & appropriate4  4  7c7       
,recognition ( =eign gov]nm5t           
inspections ,section #hji ( ! ,f$]al    
,food1 ,drug1 & ,cosmetic ,act 7#ba     
,u4,s4,c4 #chd;e7 is am5d$-- 7#a7 9     
subsection 7a77#a71 by ins]t+           
preapproval or be=e risk-bas$           
inspections2 &  7#b7 by add+ at ! end ! 
foll[+3  7c7 ,p]iodic review  7#a7 ,9   
g5]al ,beg9n+ n lat] ?an #a ye> aft] !  

date ( ! enactm5t ( ! ,,inspections ,act
 ! ,secret>y %all p]iodically assess    
:e!r additional arrangem5ts & agreem5ts 
) a =eign gov]nm5t or an ag5cy ( a =eign
 gov]nm5t1 z all[$ "u ?is section1 are  
appropriate4  7#b7 ,reports to ,congress
 ,beg9n+ n lat] ?an #d ye>s aft] ! date 
( ! enactm5t ( ! ,,inspections ,act1 & e
 #d ye>s !reaft]1 ! ,secret>y %all      
submit to ! ,committee on ,en]gy &      
,comm]ce ( ! ,h\se ( ,repres5tatives & !
 ,committee on ,heal?1 ,education1      
,labor & ,p5sions a report describ+ !   
f9d+s & conclusions ( ea* review        
conduct$ "u p>agraph 7#a74  4  #c4 ,,gao
 report on inspections ( =eign          
e/abli%m5ts manufactur+ drugs  7a7 ,9   
g5]al ,n lat] ?an #ah mon?s aft] ! date 
( ! enactm5t ( ?is ,act1 ! ,comptroll]  
,g5]al ( ! ,unit$ ,/ates %all submit to 
! ,committee on ,en]gy & ,comm]ce ( !   
,h\se ( ,repres5tatives & ! ,committee  
on ,heal?1 ,education1 ,labor & ,p5sions
 ( ! ,s5ate a report on inspections (   
=eign e/abli%m5ts conduct$ by !         

,secret>y ( ,heal? & ,human ,s]vices    
pursuant to subsections 7h7 & 7i7 (     
section #eaj & section #gjd ( ! ,f$]al  
,food1 ,drug1 & ,cosmetic ,act 7#ba     
,u4,s4,c4 #cfj1 #cgd7 7or a =eign       
gov]nm5t or an ag5cy ( a =eign gov]nm5t 
pursuant to section #hji ( su* ,act 7#ba
 ,u4,s4,c4 #chd;e774  7b7 ,cont5ts ,!   
report conduct$ "u subsection 7a7 %all  
include-- 7#a7 :at alt]native tools1    
includ+ remote inspections1 o!r c\ntries
 are utiliz+ to facilitate inspections (
 =eign e/abli%m5ts2  7#b7 h[ frequ5tly  
tru/$ =eign regulators conduct          
inspections ( =eign facilities t c\ld be
 useful to ! ,food & ,drug ,adm9i/ration
 to review 9 lieu ( its own inspections2
  7#c7 h[ frequ5tly & "u :at            
circum/ances1 includ+ = :at types (     
inspections1 ! ,secret>y utilizes exi/+ 
agreem5ts or arrangem5ts "u section #hji
 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic   
,act 7#ba ,u4,s4,c4 #chd;e7 & :e!r ! use
 ( su* agreem5ts c\ld be appropriately  
exp&$2  7#d7 :e!r ! ,secret>y has       

accept$ reports ( inspections (         
facilities 9 ,*9a & ,india conduct$ by  
entities ) :i* !y h ent]$ into su* an   
agreem5t or arrangem5t2  7#e7 :at       
additional =eign gov]nm5ts or ag5cies ( 
=eign gov]nm5ts ! ,secret>y has consid]$
 ent]+ into a mutual recognition        
agreem5t ) &1 if applicable1 reasons :y 
! ,secret>y decl9$ to ent] into a mutual
 recognition agreem5t ) su* =eign       
gov]nm5ts or ag5cies2  7#f7 :at tools1  
if any1 ! ,secret>y us$ to facilitate   
inspections ( dome/ic facilities t c\ld 
also be effectively utiliz$ to          
appropriately inspect =eign facilities2 
7#g7 :at /eps ! ,secret>y has tak5 to   
id5tify & evaluate tools & /rategies !  
,secret>y may use to cont9ue ov]sight ) 
respect to inspections :5 9-p]son       
inspections are disrupt$2  7#h7 h[ !    
,secret>y is consid]+ incorporat+       
alt]native tools into ! inspection      
activities conduct$ pursuant to ! ,f$]al
 ,food1 ,drug1 & ,cosmetic ,act 7#ba    
,u4,s4,c4 #cba et seq472 &  7#i7 :at    

/eps ! ,secret>y has tak5 to id5tify &  
evaluate h[ ! ,secret>y may use         
alt]native tools to address work=ce     
%ortages to c>ry out su* inspection     
activities4