,i  #aai? ,,congress  #b;d ,session  ,h4
 ,r4 #hcci  ,,9 ,,! ,,h\se ,,(          
,,repres5tatives  ,april #af1 #bjbf,ms4 
,matsui 7= h]self1 ,mr4 ,cr5%aw1 ,ms4   
,s*ri]1 & ,mrs4 ,h9son7 introduc$ !     
foll[+ bill2 :i* 0 ref]r$ to !          
,committee on ,en]gy & ,comm]ce  ,a     
,,bill  ,to am5d ! ,f$]al ,food1 ,drug1 
& ,cosmetic ,act to enhance drug        
manufactur+ am\nt in=mation report+1 & =
 o!r purposes4  #a4 ,%ort title ,?is    
,act may be cit$ z ! ,drug ,orig9       
,transp>5cy ,act ( #bjbf4  #b4 ,enhanc$ 
drug manufactur+ am\nt in=mation report+
  7a7 ,9 g5]al ,section #eaj7;j77#c7 ( !
 ,f$]al ,food1 ,drug1 & ,cosmetic ,act  
7#ba ,u4,s4,c4 #cfj7;j77#c77 is am5d$-- 
7#a7 9 subp>agraph 7,a71 by add+ or 7#b7
 aft] p>agraph 7#a72 &  7#b7 by add+ at 
! end ! foll[+3  7,c7 ,ea* report       
submitt$ pursuant to subp>agraph 7,a7 ) 
respect to a drug %all--  7i7 include   
additional in=mation z may be specifi$  
by ! ,secret>y 9 regulation or guidance 
reg>d+ ! supply *a9 = su* drug1 su* z-- 

7,i7 ! id5tity ( ! respective suppli]s (
 ea* active ph>maceutical +r$i5t1 active
 ph>maceutical +r$i5t int]m$iate1 &     
9-process mat]ial us$ 9 su* manufacture1
 prep>ation1 propagation1 comp\nd+1 or  
process+ ( ! drug2 &  7,,ii7 !          
respective am\nts ( su* drug t 7        
manufactur$1 prep>$1 propagat$1         
comp\nd$1 or process$ us+ an active     
ph>maceutical +r$i5t1 active            
ph>maceutical +r$i5t int]m$iate1 &      
9-process mat]ial f ea* su* id5tifi$    
suppli]2 &  7ii7 be submitt$ m frequ5tly
 ?an annually1 9 accordance ) a report+ 
s*$ule z may be specifi$ by ! ,secret>y 
9 su* regulation or guidance1 b n m     
frequ5tly ?an #d times p] ye>4  7,d7    
,any additional in=mation specifi$ 9    
regulation or guidance pursuant to      
subp>agraph 7,c7 %all be a requir$      
elem5t ( reports "u ?is p>agraph n e>li]
 ?an #f mon?s aft] ! date on :i* su*    
regulation or guidance is issu$ 9 f9al  
=m 7& 9 no ev5t %all ! abs5ce ( any     
regulation or guidance issu$ "u         

subp>agraph 7,c7 affect ! requirem5t to 
report z describ$ 9 subp>agraph 7,a774  
4  7b7 ,con=m+ am5dm5t ,section         
#eaj7;j77#c77;,b7 ( ! ,f$]al ,food1     
,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4  
#eaj7;j77#c77;,b77 is am5d$ by /rik+    
subp>agraph 7,a7 & ins]t+ ?is p>agraph4 
#c4 ,require drug label+ to include     
orig9al manufactur] & supply *a9        
in=mation ,section #ejb ( ! ,f$]al      
,food1 ,drug1 & ,cosmetic ,act 7#ba     
,u4,s4,c4 #ceb7 is am5d$-- 7#a7 9       
p>agraph 7b7--  7,a7 by /rik+ 7b7 ,if 9 
a package & ins]t+ 7b77#a7 ,if 9 a      
package2  7,b7 by /rik+ a label conta9+ 
7#a7 ! "n & place & ins]t+  a label     
conta9+-- 7,a7 ! "n & place  2  7,c7 by 
/rik+ or di/ributor2 & 7#b7 an accurate 
/atem5t & ins]t+ or di/ributor2 &  7,b7 
an accurate /atem5t  2  7,d7 by /rik+ "u
 clause 7#b7 ( ?is p>agraph & ins]t+ "u 
?is clause2 &  7,e7 by ins]t+ at ! end !
 foll[+3  7#b7 7,a7 ,subject to clause  
7,c71 if x is a drug1 includ+ an active 
ph>maceutical +r$i5t1 unless x be>s a   

label conta9+ ! "n & place ( bus9ess1 & 
unique facility id5tifi] ( ! orig9al    
manufactur] ( su* drug or active        
ph>maceutical +r$i5t1 except t !        
,secret>y may provide1 by regulation1 = 
reasonable v>iations 9 ! implem5tation (
 su* label+ requirem5ts4  7,b7 ,subject 
to clause 7,c71 if x is a drug t is an  
active ph>maceutical +r$i5t1 unless any 
accompany+ c]tificate ( analysis conta9s
 ! "n & place ( bus9ess1 & unique       
facility id5tifi] ( ! orig9al           
manufactur] ( ! active ph>maceutical    
+r$i5t4  7,c7 ,! ,secret>y may provide1 
by regulation1 = reasonable v>iations 9 
! implem5tation ( label+ requirem5ts    
specifi$ 9 ?is subp>agraph4  2 &  7#b7  
by ins]t+ aft] p>agraph 7c7 ! foll[+3   
7d7 7#a7 ,subject to subp>agraph 7#b71  
if x is a drug1 includ+ an active       
ph>maceutical +r$i5t1 unless x be>s     
label+ conta9+ ! "n & place ( bus9ess   
(--  7,a7 ! orig9al manufactur] ( ea*   
active ph>maceutical +r$i5t2  7,b7 ea*  
manufactur]1 if diff]5t f ! orig9al     

manufactur]2 &  7,c7 ! pack] or         
di/ributor1 if any4  7#b7 ,! ,secret>y  
may provide1 by regulation1 = reasonable
 v>iations or an alt]native placem5t = !
 label+ requirem5ts specifi$ 9          
subp>agraph 7#a71 includ+ by electronic 
means4  4