,,ib ,union ,cal5d> ,no4 #dga #aaf?     
,,congress  #b;d ,session  ,h4 ,r4 #effh
 ,report ,no4 #aaf-egc ,,9 ,,! ,,h\se   
,,( ,,repres5tatives  ,janu>y #bd1      
#bjbj,ms4 ,matsui 7= h]self & ,mr4      
,gu?rie7 introduc$ ! foll[+ bill2 :i* 0 
ref]r$ to ! ,committee on ,en]gy &      
,comm]ce  ,novemb] #af1                 
#bjbj;,additional sponsor3 ,mr4 ,taylor 
,novemb] #af1 #bjbj,report$ ) an        
am5dm5t2 committ$ to ! ,committee ( !   
,:ole ,h\se on ! ,/ate ( ! ,union &     
ord]$ to be printed,strike out all aft] 
! enact+ clause & ins]t ! "p pr9t$ 9    
italic,for text ( introduc$ bill1 see   
copy ( bill z introduc$ on ,janu>y #bd1 
#bjbj  ,a ,,bill  ,to am5d ! ,f$]al     
,food1 ,drug1 & ,cosmetic ,act to       
mod]nize ! label+ ( c]ta9 g5]ic drugs1 &
 = o!r purposes4  #a4 ,%ort title ,?is  
,act may be cit$ z ! ,mak+ ,objective   
,drug ,evid5ce ,revisions = ,new ,label+
 ,act ( #bjbj or ! ,,mod]n ,label+ ,act 
( #bjbj4  #b4 ,mod]niz+ ! label+ ( c]ta9
 g5]ic drugs ,*apt] ,v ( ! ,f$]al ,food1

 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 
#cea et seq47 is am5d$ by ins]t+ aft]   
section #ejc;,c ! foll[+3  #ejc;,d4     
,process to update label+ = c]ta9 drugs 
7a7 ,def9itions ,= purposes ( ?is       
section3 7#a7 ,! t]m cov]$ drug means a 
drug approv$ "u section #eje7;c7-- 7,a7 
= :i* !re are no unexpir$ pat5ts includ$
 9 ! li/ "u section #eje7;j77#g7 & no   
unexpir$ p]iod ( exclusivity2  7,b7 =   
:i* ! approval ( ! application has be5  
)drawn = reasons o!r ?an safety or      
effectiv5ess2 &  7,c7 = :i*-- 7i7 7,i7  
!re is new sci5tific evid5ce available  
p]ta9+ to ! exi/+ conditions ( use t is 
n reflect$ 9 ! label+2  7,,ii7 ! approv$
 label+ does n reflect curr5t legal &   
regulatory requirem5ts = cont5t or =mat2
 or  7,,iii7 !re is a relevant accept$  
use 9 cl9ical practice t is n reflect$ 9
 ! approv$ label+2 &  7ii7 updat+ !     
label+ w\ld b5efit ! public heal?4  7#b7
 ,! t]m p]iod ( exclusivity1 ) respect  
to a drug approv$ "u section #eje7;c71  
means any p]iod ( exclusivity "u clause 

7ii71 7iii71 or 7iv7 ( section          
#eje7;c77#c77;,e71 clause 7ii71 7iii71  
or 7iv7 ( section #eje7;j77#e77;,f71 or 
section #eje;,a1 #eje;,e1 or #ebg4  7#c7
 ,! t]m g5]ic v]sion means a drug       
approv$ "u section #eje7;j7 ^: ref]5ce  
li/$ drug is a cov]$ drug4  7#d7 ,! t]m 
relevant accept$ use means a use = a    
drug 9 cl9ical practice t is support$ by
 sci5tific evid5ce t appe>s to !        
,secret>y to meet ! /&>ds = approval "u 
section #eje4  7#e7 ,! t]m select$ drug 
means a cov]$ drug = :i* ! ,secret>y has
 det]m9$ ?r\gh ! process "u subsection  
7c7 t ! label+ %\ld be *ang$4  7b7      
,id5tification ( cov]$ drugs ,!         
,secret>y may id5tify cov]$ drugs = :i* 
label+ updates w\ld provide a public    
heal? b5efit4 ,to assi/ 9 id5tify+ cov]$
 drugs1 ! ,secret>y may d "o or bo? ( ! 
foll[+3 7#a7 ,ent] into coop]ative      
agreem5ts or contracts ) public or      
private entities to review ! available  
sci5tific evid5ce conc]n+ su* drugs4    
7#b7 ,seek public input conc]n+ su*     

drugs1 includ+ input on :e!r !re is a   
relevant accept$ use 9 cl9ical practice 
t is n reflect$ 9 ! approv$ label+ ( su*
 drugs or :e!r new sci5tific evid5ce is 
available reg>d+ ! conditions ( use =   
su* drug1 by-- 7,a7 hold+ "o or m public
 meet+s2  7,b7 op5+ a public docket = ! 
submission ( public comm5ts2 or  7,c7   
o!r means1 z ! ,secret>y det]m9es       
appropriate4  7c7 ,selection ( drugs =  
updat+ ,if ! ,secret>y det]m9es1 )      
respect to a cov]$ drug1 t ! available  
sci5tific evid5ce meets ! /&>ds "u      
section #eje = add+ or modify+ in=mation
 to ! label+ or provid+ supplem5tal     
in=mation to ! label+ reg>d+ ! use ( !  
cov]$ drug1 ! ,secret>y may initiate !  
process "u subsection 7d74  7d7         
,initiation ( ! process ( updat+ ,if !  
,secret>y det]m9es t label+ *anges are  
appropriate = a select$ drug pursuant to
 subsection 7c71 ! ,secret>y %all       
provide notice to ! hold]s ( approv$    
applications = a g5]ic v]sion ( su* drug
 t-- 7#a7 summ>izes ! f9d+s support+ !  

det]m9ation ( ! ,secret>y t ! available 
sci5tific evid5ce meets ! /&>ds "u      
section #eje = add+ or modify+ in=mation
 or provid+ supplem5tal in=mation to !  
label+ ( ! cov]$ drug pursuant to       
subsection 7c72  7#b7 provides a cle>   
/atem5t reg>d+ ! additional1 modifi$1 or
 supplem5tal in=mation = su* label+1    
accord+ to ! det]m9ation by ! ,secret>y 
7includ+1 z applicable1 modifications to
 add ! relevant accept$ use to ! label+ 
( ! drug z an additional indication = ! 
drug72 &  7#c7 /ates :e!r ! /atem5t "u  
p>agraph 7#b7 applies to ! select$ drug 
z a class ( cov]$ drugs or only to a    
specific drug product4  7e7 ,response to
 notification ,)9 #cj days ( receipt (  
notification provid$ by ! ,secret>y     
pursuant to subsection 7d71 ! hold] ( an
 approv$ application = a g5]ic v]sion ( 
! select$ drug %all-- 7#a7 agree to     
*ange ! approv$ label+ to reflect !     
additional1 modifi$1 or supplem5tal     
in=mation ! ,secret>y has det]m9$ to be 
appropriate2 or  7#b7 notify ! ,secret>y

 t ! hold] ( ! approv$ application does 
n believe t ! reque/$ label+ *anges are 
w>rant$ & submit a /atem5t detail+ !    
reasons :y su* *anges are n w>rant$4    
7f7 ,review ( application hold]'s       
response  7#a7 ,9 g5]al ,^u receipt ( ! 
application hold]'s response1 !         
,secret>y %all promptly review ea*      
/atem5t receiv$ "u subsection 7e77#b7 & 
det]m9e :i* label+ *anges pursuant to ! 
,secret>y's notice "u subsection 7d7 are
 appropriate1 if any4 ,if ! ,secret>y   
disagrees ) ! reasons :y su* label+     
*anges are n w>rant$1 ! ,secret>y %all  
provide opportunity = discussions ) !   
application hold]s to rea* agreem5t on  
:e!r ! label+ = ! cov]$ drug %\ld be    
updat$ to reflect available sci5tific   
evid5ce1 & if s1 ! cont5t ( su* label+  
*anges4  7#b7 ,*anges to label+ ,aft]   
consid]+ all responses f ! hold] ( an   
approv$ application "u p>agraph 7#a7 or 
7#b7 ( subsection 7e71 & any discussion 
"u p>agraph 7#a71 ! ,secret>y may ord]  
su* hold] to make ! label+ *anges !     

,secret>y det]m9es are appropriate4 ,su*
 hold] ( an approv$ application %all--  
7,a7 update its pap] label+ = ! drug at 
! next pr9t+ ( t label+2  7,b7 update   
any electronic label+ = ! drug )9 #cj   
days ( su* ord]2 &  7,c7 submit ! revis$
 label+ ?r\gh ! =m1 ,supplem5t--,*anges 
,be+ ,effect$4  7g7 ,violation ,if !    
hold] ( an approv$ application = ! g5]ic
 v]sion ( ! select$ drug does n comply )
 ! requirem5ts ( subsection 7f77#b71 su*
 g5]ic v]sion ( ! select$ drug %all be  
deem$ to be misbr&$ "u section #ejb4    
7h7 ,limitations2 g5]ic drugs  7#a7 ,9  
g5]al ,) respect to any label+ *ange    
requir$ "u ?is section1 ! g5]ic v]sion  
%all be deem$ to h ! same conditions (  
use & ! same label+ z its ref]5ce li/$  
drug = purposes ( clauses 7i7 & 7v7 (   
section #eje7;j77#b77;,a74 ,any label+  
*ange s requir$ %all n h any legal      
effect = ! applicant t is diff]5t ?an ! 
legal effect t w\ld h result$ if a      
supplem5tal application _h be5 submitt$ 
& approv$ to con=m ! label+ ( ! g5]ic   

v]sion to a *ange 9 ! label+ ( ! ref]5ce
 drug4  7#b7 ,supplem5tal applications  
,*anges to label+ made 9 accordance )   
?is section %all n be eligible = an     
exclusivity p]iod "u ?is ,act4  7#c7    
,selection ( drugs ,no?+ 9 ?is section  
%all be con/ru$ to give ! ,secret>y !   
au?ority to id5tify a drug z a cov]$    
drug or select a drug label = updat+    
solely bas$ on ! availability ( new     
safety in=mation4 ,^u id5tification ( a 
drug z a cov]$ drug1 ! ,secret>y may !n 
consid] ! availability ( new1           
additional1 or diff]5t safety in=mation 
9 det]m9+ :e!r ! drug is a select$ drug 
& 9 det]m9+ :at label+ *anges are       
appropriate4  7#d7 ,ma9t5ance ( label+  
,no?+ 9 ?is section %all be con/ru$ to  
affect ! responsibility ( ! hold] ( an  
approv$ application "u section #eje7;j7 
to ma9ta9 its label+ 9 accordance )     
exi/+ requirem5ts1 includ+ subp>t ,b (  
"p #bja & sections #cad4gj & #cad4ig (  
title #ba1 ,code ( ,f$]al ,regulations  
7or any successor regulations74  7i7    

,rules ( con/ruction  7#a7 ,approval    
/&>ds ,?is section %all n be con/ru$ z  
alt]+ ! applicability ( ! /&>ds =       
approval ( an application "u section    
#eje4 ,no ord] %all be issu$ "u ?is     
subsection unless ! sci5tific evid5ce   
support+ ! *ang$ label+ meets ! /&>ds = 
approval applicable to any *ange to     
label+ "u section #eje4  7#b7 ,secret>y 
au?ority ,no?+ 9 ?is section %all be    
con/ru$ to limit ! au?ority ( !         
,secret>y to require label+ *anges "u   
section #eje7o74  7j7 ,reports ,n lat]  
?an #d ye>s aft] ! date ( ! enactm5t ( !
 ,mak+ ,objective ,drug ,evid5ce        
,revisions = ,new ,label+ ,act ( #bjbj1 
& e #d ye>s !reaft]1 ! ,secret>y %all   
prep>e & submit to ! ,committee on      
,en]gy & ,comm]ce ( ! ,h\se (           
,repres5tatives & ! ,committee on       
,heal?1 ,education1 ,labor1 & ,p5sions (
 ! ,s5ate1 a report t-- 7#a7 describes !
 actions ( ! ,secret>y "u ?is section1  
includ+-- 7,a7 ! numb] ( cov]$ drugs &  
description ( ! types ( drugs !         

,secret>y has select$ = label+ *anges & 
! rationale = su* recomm5d$ *anges2 &   
7,b7 ! numb] ( times ! ,secret>y ent]$  
into discussions conc]n+ a disagreem5t )
 an application hold] or hold]s & a     
summ>y ( ! decision reg>d+ a label+     
*ange1 if any2 &  7#b7 includes any     
recomm5dations ( ! ,secret>y = modify+ !
 program "u ?is section4  4  ,novemb]   
#af1 #bjbj,report$ ) an am5dm5t2        
committ$ to ! ,committee ( ! ,:ole ,h\se
 on ! ,/ate ( ! ,union & ord]$ to be    
pr9t$