#aae? ,,congress  #b;d ,session  ,h4 ,r4
 #ehaa  ,,an ,,act  ,to am5d ! ,f$]al   
,food1 ,drug1 & ,cosmetic ,act ) respect
 to po/approval /udy requirem5ts = c]ta9
 controll$ sub/ances1 & = o!r purposes4 
#a4 ,po/approval /udy requirem5ts  7a7  
,purposes ( /udy ,section               
#eje7o77#c77;,b7 ( ! ,f$]al ,food1      
,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4  
#cee7o77#c77;,b77 is am5d$ by add+ at ! 
end ! foll[+3  7iv7 ,to assess a        
pot5tial r$uction 9 effectiv5ess ( !    
drug = ! conditions ( use prescrib$1    
recomm5d$1 or sugge/$ 9 ! label+ !re(   
if--  7,i7 ! drug involv$-- 7aa7 is or  
conta9s a sub/ance = :i* a li/+ 9 any   
s*$ule is 9 effect 7on a tempor>y or    
p]man5t basis7 "u section #bja ( !      
,controll$ ,sub/ances ,act2 or  7bb7 is 
a drug t has n be5 approv$ "u ?is       
section or lic5s$ "u section #cea ( !   
,public ,heal? ,s]vice ,act1 = :i* an   
application = su* approval or lic5sure  
is p5d+ or anticipat$1 & = :i* !        
,secret>y provides notice to ! sponsor t

 ! ,secret>y int5ds to issue a sci5tific
 & m$ical evaluation & recomm5d controls
 "u ! ,controll$ ,sub/ances ,act2 &     
7,,ii7 ! pot5tial r$uction 9            
effectiv5ess c\ld result 9 ! b5efits ( !
 drug no long] outweigh+ ! risks4  4    
7b7 ,e/abli%m5t ( requirem5t ,section   
#eje7o77#c77;,c7 ( ! ,f$]al ,food1      
,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4  
#cee7o77#c77;,c77 is am5d$ by /rik+ su* 
requirem5t & all t foll[s ?r\gh safety  
in=mation4 & ins]t+ ! foll[+3 su*       
requirem5t--  7i7 9 ! case ( a purpose  
describ$ 9 clause 7i71 7ii71 or 7iii7 ( 
subp>agraph 7,b71 only if ! ,secret>y   
becomes aw>e ( new safety in=mation2 &  
7ii7 9 ! case ( a purpose describ$ 9    
clause 7iv7 ( su* subp>agraph1 if !     
,secret>y det]m9es t new effectiv5ess   
in=mation exi/s4  4  7c7 ,applicability 
,section #eje7o77#c7 ( ! ,f$]al ,food1  
,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4  
#cee7o77#c77 is am5d$ by add+ at ! end !
 foll[+ new subp>agraph3  7,g7          
,applicability ,! conduct ( a /udy or   

cl9ical trial requir$ pursuant to ?is   
p>agraph = ! purpose specifi$ 9         
subp>agraph 7,b77iv7 %all n be consid]$ 
a new cl9ical inve/igation = ! purpose (
 a p]iod ( exclusivity "u clause 7iii7  
or 7iv7 ( subsection 7c77#c77;,e7 or    
clause 7iii7 or 7iv7 ( subsection       
7j77#e77;,f74  4  7d7 ,new effectiv5ess 
in=mation def9$ ,section #eje7o77#b7 ( !
 ,f$]al ,food1 ,drug1 & ,cosmetic ,act  
7#ba ,u4,s4,c4 #cee7o77#b77 is am5d$ by 
add+ at ! end ! foll[+ new subp>agraph3 
7,d7 ,new effectiv5ess in=mation ,! t]m 
new effectiv5ess in=mation1 ) respect to
 a drug t is or conta9s a controll$     
sub/ance = :i* a li/+ 9 any s*$ule is 9 
effect 7on a tempor>y or p]man5t basis7 
"u section #bja ( ! ,controll$          
,sub/ances ,act1 means new in=mation    
ab\t ! effectiv5ess ( ! drug1 includ+ a 
new analysis ( exi/+ in=mation1 d]iv$   
f--  7i7 a cl9ical trial2 an adv]se ev5t
 report2 a po/approval /udy or cl9ical  
trial 7includ+ a /udy or cl9ical trial  
"u p>agraph 7#c772  7ii7 pe]-review$    

biom$ical lit]ature2  7iii7 data d]iv$ f
 ! po/m>ket risk id5tification &        
analysis sy/em "u subsection 7k72 or    
7iv7 o!r sci5tific data det]m9$ to be   
appropriate by ! ,secret>y4  4  7e7     
,con=m+ am5dm5ts ) respect to label+    
*anges ,section #eje7o77#d7 ( ! ,f$]al  
,food1 ,drug1 & ,cosmetic ,act 7#ba     
,u4,s4,c4 #cee7o77#d77 is am5d$-- 7#a7 9
 subp>agraph 7,a7--  7,a7 9 ! head+1 by 
ins]t+ or new effectiv5ess aft] safety2 
7,b7 by /rik+ safety in=mation & ins]t+ 
new safety in=mation or new effectiv5ess
 in=mation su*2 &  7,c7 by /rik+        
believes %\ld be & ins]t+ believes      
*anges %\ld be made to2  7#b7 9         
subp>agraph 7,b77i7--  7,a7 by /rik+ new
 safety in=mation & by ins]t+ new safety
 in=mation or new effectiv5ess          
in=mation2 &  7,b7 by ins]t+            
indications1 aft] box$ w>n+s12  7#c7 9  
subp>agraph 7,c71 by ins]t+ or new      
effectiv5ess in=mation aft] safety      
in=mation2 &  7#d7 9 subp>agraph 7,e71  
by ins]t+ or new effectiv5ess in=mation 

aft] safety in=mation4  7f7 ,rule (     
con/ruction ,no?+ 9 ! am5dm5ts made by  
?is section %all be con/ru$ to alt]1 9  
any mann]1 ! mean+ or application ( !   
provisions ( p>agraph 7#c7 ( section    
#eje7o7 ( ! ,f$]al ,food1 ,drug1 &      
,cosmetic ,act 7#ba ,u4,s4,c4 #cee7o77 )
 respect to ! au?ority ( ! ,secret>y (  
,heal? & ,human ,s]vices to require a   
po/approval /udy or cl9ical trial = a   
purpose specifi$ 9 clauses 7i7 ?r\gh    
7iii7 ( subp>agraph 7,b7 ( su* p>agraph 
7#c7 or p>agraph 7#d7 ( su* section     
#eje7o7 ) respect to ! ,secret>y's      
au?ority to require safety label+       
*anges4  ,pass$ ! ,h\se (               
,repres5tatives ,june #ai1 #bjah4;,cl]k4