,i  #aag? ,,congress  #b;d ,session  ,h4
 ,r4 #fdhc  ,,9 ,,! ,,h\se ,,(          
,,repres5tatives  ,janu>y #be1 #bjbb    
,ms4 ,e%oo introduc$ ! foll[+ bill2 :i* 
0 ref]r$ to ! ,committee on ,en]gy &    
,comm]ce  ,a ,,bill  ,to am5d ! ,f$]al  
,food1 ,drug1 & ,cosmetic ,act to cl>ify
 report+ requirem5ts = e/abli%m5ts )9 a 
=eign c\ntry engag$ 9 ! manufacture1    
prep>ation1 propagation1 comp\nd+1 or   
process+ ( an active ph>maceutical      
+r$i5t1 & = o!r purposes4  #a4 ,%ort    
title ,?is ,act may be cit$ z ! ,improv$
 ,transp>5cy ( ,=eign ,drug ,manufactur+
 ,act ( #bjbb4  #b4 ,report+ requirem5t 
= drug manufactur]s  7a7 ,e/abli%m5ts 9 
a =eign c\ntry ,section #eaj7;i7 ( !    
,f$]al ,food1 ,drug1 & ,cosmetic ,act   
7#ba ,u4,s4,c4 #cfj7;i77 is am5d$ by    
ins]t+ at ! end ! foll[+3  7#e7 ,!      
requirem5ts ( p>agraphs 7#a7 & 7#b7 %all
 apply to e/abli%m5ts )9 a =eign c\ntry 
engag$ 9 ! manufacture1 prep>ation1     
propagation1 comp\nd+1 or process+ ( any
 drug1 includ+ ! active ph>maceutical   

+r$i5t1 t is requir$ to be li/$ pursuant
 to subsection 7j74 ,su* requirem5ts    
%all apply reg>dless ( :e!r ! drug or   
active ph>maceutical +r$i5t und]goes    
fur!r manufacture1 prep>ation1          
propagation1 comp\nd+1 or process+ at a 
sep>ate e/abli%m5t or e/abli%m5ts       
outside ! ,unit$ ,/ates prior to be+    
import$ or (f]$ = import into ! ,unit$  
,/ates4  4  7b7 ,li/+ ( drugs ,section  
#eaj7;j77#a7 ( ! ,f$]al ,food1 ,drug1 & 
,cosmetic ,act 7#ba ,u4,s4,c4           
#cfj7;j77#a77 is am5d$--  7#a7 9        
subp>agraph 7,d71 by /rik+ & at ! end2  
7#b7 9 subp>agraph 7,e71 by /rik+ !     
p]iod at ! end & ins]t+ 2 &2 &  7#c7 by 
add+ at ! end ! foll[+3  7,f7 9 ! case (
 a drug conta9$ 9 ! applicable li/1 a   
c]tification t ! regi/rant has--  7i7   
id5tifi$ e o!r kn[n e/abli%m5t :]e      
manufactur+ is p]=m$ = ! drug2 &  7ii7  
notifi$ ea* kn[n =eign e/abli%m5t engag$
 9 ! manufacture1 prep>ation1           
propagation1 comp\nd+1 or process+ ( !  
drug1 includ+ ! active ph>maceutical    

+r$i5t1 ( ! inclusion ( ! drug 9 ! li/ &
 ! obligation to regi/]4  4  7c7        
,qu>t]ly report+ on am\nt ( drugs       
manufactur$ ,section #eaj7;j77#c77;,a7 (
 ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act
 7z add$ by section #caab ( ! ,,c>es    
,act 7,public ,law #aaf-acf77 is am5d$  
by /rik+ annually & ins]t+ once dur+ !  
mon? ( ,m>* ( ea* ye>1 once dur+ ! mon? 
( ,june ( ea* ye>1 once dur+ ! mon? (   
,septemb] ( ea* ye>1 & once dur+ ! mon? 
( ,decemb] ( ea* ye>4