#aai? ,,congress  #a/ ,session  ,h4 ,r4 
#abfb  ,,an ,,act  ,to am5d ! ,f$]al    
,food1 ,drug1 & ,cosmetic ,act ) respect
 to molecul>ly t>get$ p$iatric canc]    
inve/igations1 & = o!r purposes4  #a4   
,%ort title2 table ( cont5ts  7a7 ,%ort 
title ,?is ,act may be cit$ z ! ,mikaela
 ,naylon ,give ,kids a ,*ance ,act4  7b7
 ,table ( cont5ts ,! table ( cont5ts =  
?is ,act is z foll[s3  ,sec4 #a4 ,%ort  
title2 table ( cont5ts4 ,sec4 #b4       
,rese>* into p$iatric uses ( drugs2     
additional au?orities ( ,food & ,drug   
,adm9i/ration reg>d+ molecul>ly t>get$  
canc] drugs4 ,sec4 #c4 ,ensur+          
completion ( p$iatric /udy requirem5ts4 
,sec4 #d4 ,,fda report on ,,prea        
en=cem5t4 ,sec4 #e4 ,ext5sion ( au?ority
 to issue priority review v\*]s to      
enc\rage treatm5ts = r>e p$iatric       
diseases4 ,sec4 #f4 ,limitations on     
exclusive approval or lic5sure ( orphan 
drugs4 ,sec4 #g4 ,program = p$iatric    
/udies ( drugs4 ,sec4 #h4 ,organ        
,procurem5t & ,transplantation ,network4

 ,sec4 #i4 ,e/abli%m5t ( ,abraham       
,accords ,(fice )9 ,food & ,drug        
,adm9i/ration4 ,sec4 #aj4 ,increas+     
transp>5cy 9 g5]ic drug applications4   
,sec4 #aa4 ,m$ic>e ,improvem5t ,fund4   
#b4 ,rese>* into p$iatric uses ( drugs2 
additional au?orities ( ,food & ,drug   
,adm9i/ration reg>d+ molecul>ly t>get$  
canc] drugs  7a7 ,9 g5]al  7#a7         
,additional active +r$i5t = application 
drug2 limitation reg>d+ novel-comb9ation
 application drug ,section              
#eje;,b7a77#c7 ( ! ,f$]al ,food1 ,drug1 
& ,cosmetic ,act 7#ba ,u4,s4,c4         
#cee;c7a77#c77 is am5d$-- 7,a7 by       
r$esignat+ subp>agraphs 7,b7 & 7,c7 z   
subp>agraphs 7,c7 & 7,d71 respectively2 
&  7,b7 by /rik+ subp>agraph 7,a7 &     
ins]t+ ! foll[+3  7,a7 ,9 g5]al ,=      
purposes ( p>agraph 7#a77;,b71 !        
inve/igation describ$ 9 ?is p>agraph is 
a molecul>ly t>get$ p$iatric canc]      
inve/igation (--  7i7 ! drug or         
biological product = :i* ! application  
ref]r$ to 9 su* p>agraph is submitt$2 or

  7ii7 su* drug or biological product   
us$ 9 comb9ation )--  7,i7 an active    
+r$i5t ( a drug or biological product-- 
7aa7 = :i* an approv$ application "u    
section #eje7;j7 "u ?is ,act or "u      
section #cea7k7 ( ! ,public ,heal?      
,s]vice ,act is 9 effect2 &  7bb7 t is  
det]m9$ by ! ,secret>y1 aft]            
consultation ) ! applicant1 to be "p ( !
 /&>d ( c>e = treat+ a p$iatric canc]2  
or  7,,ii7 an active +r$i5t ( a drug or 
biological product--  7aa7 = :i* an     
approv$ application "u section #eje7;b7 
( ?is ,act or section #cea7;a7 ( !      
,public ,heal? ,s]vice ,act to treat an 
adult canc] is 9 effect & is held by !  
same p]son submitt+ ! application "u    
p>agraph 7#a77;,b72 &  7bb7 t is direct$
 at a molecul> t>get t ! ,secret>y      
det]m9es to be sub/antially relevant to 
! gr[? or progression ( a p$iatric      
canc]4  7,b7 ,additional requirem5ts    
7i7 ,design ( inve/igation ,a molecul>ly
 t>get$ p$iatric canc] inve/igation     
ref]r$ to 9 subp>agraph 7,a7 %all be    

design$ to yield cl9ically mean+ful     
p$iatric /udy data t is ga!r$ us+       
appropriate =mulations = ea* age gr\p = 
:i* ! /udy is requir$1 reg>d+ dos+1     
safety1 & prelim9>y efficacy to in=m    
pot5tial p$iatric label+4  7ii7         
,limitation ,an inve/igation describ$ 9 
subp>agraph 7,a77ii7 may be requir$ only
 if ! drug or biological product = :i* !
 application ref]r$ to 9 p>agraph       
7#a77;,b7 conta9s ei!r--  7,i7 a s+le   
new active +r$i5t2 or  7,,ii7 m ?an "o  
active +r$i5t1 if an application = !    
comb9ation ( active +r$i5ts has n       
previ\sly be5 approv$ b ea* active      
+r$i5t is 9 a drug product t has be5    
previ\sly approv$ to treat an adult     
canc]4  7iii7 ,results (                
already-complet$ precl9ical /udies (    
application drug ,) respect to an       
inve/igation requir$ pursuant to        
p>agraph 7#a77;,b71 ! ,secret>y may     
require ! results ( any complet$        
precl9ical /udies relevant to ! initial 
p$iatric /udy plan be submitt$ to !     

,secret>y at ! same "t t ! initial      
p$iatric /udy plan requir$ "u subsection
 7e77#a7 is submitt$4  7iv7 ,rule (     
con/ruction reg>d+ inactive +r$i5ts ,)  
respect to a comb9ation ( active +r$i5ts
 ref]r$ to 9 subp>agraph 7,a77ii71 su*  
subp>agraph %all n be con/ru$ z address+
 ! use ( inactive +r$i5ts ) su*         
comb9ation4  4  7#b7 ,det]m9ation (     
applicable requirem5ts ,section         
#eje;,b7e77#a7 ( ! ,f$]al ,food1 ,drug1 
& ,cosmetic ,act 7#ba ,u4,s4,c4         
#cee;c7e77#a77 is am5d$ by add+ at ! end
 ! foll[+3 ,! ,secret>y %all det]m9e    
:e!r subp>agraph 7,a7 or 7,b7 (         
subsection 7a77#a7 applies ) respect to 
an application be=e ! date on :i* !     
applicant is requir$ to submit ! initial
 p$iatric /udy plan "u p>agraph         
7#b77;,a744  7#c7 ,cl>ify+ applicability
 ,section #eje;,b7a77#a7 ( ! ,f$]al     
,food1 ,drug1 & ,cosmetic ,act 7#ba     
,u4,s4,c4 #cee;c7a77#a77 is am5d$ by    
add+ at ! end ! foll[+3  7,c7 ,rule (   
con/ruction ,no application t is subject

 to ! requirem5ts ( subp>agraph 7,b7    
%all be subject to ! requirem5ts (      
subp>agraph 7,a71 & no application 7or  
supplem5t to an application7 t is       
subject to ! requirem5ts ( subp>agraph  
7,a7 %all be subject to ! requirem5ts ( 
subp>agraph 7,b74  4  7#d7 ,con=m+      
am5dm5ts ,section #eje;,b7a7 ( ! ,f$]al 
,food1 ,drug1 & ,cosmetic ,act 7#ba     
,u4,s4,c4 #cee;c7a77 is am5d$--  7,a7 9 
p>agraph 7#c77;,c71 z r$esignat$ by     
p>agraph 7#a77;,a7 ( ?is subsection1 by 
/rik+ inve/igations describ$ 9 ?is      
p>agraph & ins]t+ inve/igations ref]r$  
to 9 subp>agraph 7,a72 &  7,b7 9        
p>agraph 7#c77;,d71 z r$esignat$ by     
p>agraph 7#a77;,a7 ( ?is subsection1 by 
/rik+ ! assessm5ts "u p>agraph 7#b77;,b7
 & ins]t+ ! assessm5ts requir$ "u       
p>agraph 7#a77;,a74  7b7 ,guidance ,!   
,secret>y ( ,heal? & ,human ,s]vices1   
act+ ?r\gh ! ,commission] ( ,food &     
,drugs1 %all-- 7#a7 n lat] ?an #ab mon?s
 aft] ! date ( enactm5t ( ?is ,act1     
issue draft guidance on ! implem5tation 

( ! am5dm5ts made by subsection 7a72 &  
7#b7 n lat] ?an #ab mon?s aft] clos+ !  
comm5t p]iod on su* draft guidance1     
f9alize su* guidance4  7c7              
,applicability ,! am5dm5ts made by ?is  
section apply ) respect to any          
application "u section #eje7;b7 ( !     
,f$]al ,food1 ,drug1 & ,cosmetic ,act   
7#ba ,u4,s4,c4 #cee7;b77 & any          
application "u section #cea7;a7 ( !     
,public ,heal? ,s]vice ,act 7#db        
,u4,s4,c4 #bfb7;a771 t is submitt$ on or
 aft] ! date t is #c ye>s aft] ! date ( 
enactm5t ( ?is ,act4  7d7 ,reports to   
,congress  7#a7 ,secret>y ( ,heal? &    
,human ,s]vices ,n lat] ?an #f ye>s aft]
 ! date ( enactm5t ( ?is ,act1 !        
,secret>y ( ,heal? & ,human ,s]vices    
%all submit to ! ,committee on ,en]gy & 
,comm]ce ( ! ,h\se ( ,repres5tatives & !
 ,committee on ,heal?1 ,education1      
,labor1 & ,p5sions ( ! ,s5ate a report  
on ! ,secret>y's ef=ts1 9 coord9ation ) 
indu/ry1 to ensure implem5tation ( !    
am5dm5ts made by subsection 7a74  7#b7  

,,gao /udy & report  7,a7 ,/udy ,n lat] 
?an #h ye>s aft] ! date ( enactm5t ( ?is
 ,act1 ! ,comptroll] ,g5]al ( ! ,unit$  
,/ates %all conduct a /udy ( !          
effectiv5ess ( requir+ assessm5ts &     
inve/igations describ$ 9 section #eje;,b
 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic   
,act 7#ba ,u4,s4,c4 #cee;c71 z am5d$ by 
subsection 7a71 9 ! developm5t ( drugs &
 biological products = p$iatric canc]   
indications1 includ+ consid]ation ( any 
b5efits to1 or burd5s on1 p$iatric canc]
 drug developm5t4  7,b7 ,f9d+s ,n lat]  
?an #aj ye>s aft] ! date ( enactm5t (   
?is ,act1 ! ,comptroll] ,g5]al %all     
submit to ! ,committee on ,en]gy &      
,comm]ce ( ! ,h\se ( ,repres5tatives & !
 ,committee on ,heal?1 ,education1      
,labor1 & ,p5sions ( ! ,s5ate a report  
conta9+ ! f9d+s ( ! /udy conduct$ "u    
subp>agraph 7,a74  #c4 ,ensur+          
completion ( p$iatric /udy requirem5ts  
7a7 ,equal acc\ntability = p$iatric /udy
 requirem5ts ,section #eje;,b7d7 ( !    
,f$]al ,food1 ,drug1 & ,cosmetic ,act   

7#ba ,u4,s4,c4 #cee;c7d77 is am5d$--    
7#a7 9 p>agraph 7#a71 by /rik+ ,beg9n+  
#bgj & ins]t+ ,noncompliance            
lett]4--,beg9n+ #bgj2  7#b7 9 p>agraph  
7#b7--  7,a7 by /rik+ ,! drug or &      
ins]t+ ,effect ( noncompliance4--,! drug
 or2 &  7,b7 by /rik+ 7except t ! drug  
or biological product %all n be subject 
to action "u section #cjc7 & ins]t+     
7except t ! drug or biological product  
%all be subject to action "u section    
#cjc only if su* p]son demon/rat$ a lack
 ( due dilig5ce 9 satisfy+ ! applicable 
requirem5t72 &  7#c7 by add+ at ! end ! 
foll[+3  7#c7 ,limitation ,! ,secret>y  
%all n issue en=cem5t actions "u section
 #cjc = failures "u ?is subsection 9 !  
case ( a drug or biological product t is
 no long] m>ket$4  4  7b7 ,due dilig5ce 
,section #eje;,b7d7 ( ! ,f$]al ,food1   
,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4  
#cee;c7d771 z am5d$ by subsection 7a71  
is fur!r am5d$ by add+ at ! end !       
foll[+3  7#d7 ,due dilig5ce ,be=e !     
,secret>y may conclude t a p]son fail$  

to submit or o!rwise meet a requirem5t z
 describ$ 9 ! matt] prec$+ p>agraph     
7#a71 ! ,secret>y %all--  7,a7 issue a  
noncompliance lett] pursuant to p>agraph
 7#a72  7,b7 provide su* p]son ) a      
#de-;day p]iod beg9n+ on ! date (       
receipt ( su* noncompliance lett] to    
respond 9 writ+ z set =? 9 su* p>agraph2
 &  7,c7 aft] review+ su* writt5        
response1 det]m9e :e!r ! p]son          
demon/rat$ a lack ( due dilig5ce 9      
satisfy+ su* requirem5t4  4  7c7 ,con=m+
 am5dm5ts ,section #cjc7;f77#d77;,a7 ( !
 ,f$]al ,food1 ,drug1 & ,cosmetic ,act  
7#ba ,u4,s4,c4 #ccc7;f77#d77;,a77 is    
am5d$ by /rik+ or #eje-a & ins]t+       
#eje-a1 or #eje;,b4  7d7 ,transition    
rule ,! ,secret>y ( ,heal? & ,human     
,s]vices may take en=cem5t action "u    
section #cjc ( ! ,f$]al ,food1 ,drug1 & 
,cosmetic ,act 7#ba ,u4,s4,c4 #ccc7 only
 = failures describ$ 9 section          
#eje;,b7d7 ( su* ,act 7#ba ,u4,s4,c4    
#cee;c7d77 t occur on or aft] ! date t  
is #ahj days aft] ! date ( enactm5t (   

?is ,act4  #d4 ,,fda report on ,,prea   
en=cem5t ,section #ejh7;b7 ( ! ,food &  
,drug ,adm9i/ration ,safety &           
,innovation ,act 7#ba ,u4,s4,c4         
#cee;c-#a7;b77 is am5d$--  7#a7 9       
p>agraph 7#aa71 by /rik+ ! semicolon at 
! end & ins]t+ 1 includ+ an evaluation (
 compliance ) deadl9es provid$ = 9      
def]rals & def]ral ext5sions22  7#b7 9  
p>agraph 7#ae71 by /rik+ & at ! end2    
7#c7 9 p>agraph 7#af71 by /rik+ ! p]iod 
at ! end & ins]t+ 2 &2 &  7#d7 by add+  
at ! end ! foll[+3  7#ag7 a li/+ (      
p5alties1 settlem5ts1 or paym5ts "u     
section #cjc ( ! ,f$]al ,food1 ,drug1 & 
,cosmetic ,act 7#ba ,u4,s4,c4 #cec7 =   
failure to comply ) requirem5ts "u su*  
section #eje;,b1 includ+1 = ea* p5alty1 
settlem5t1 or paym5t1 ! "n ( ! drug1 !  
sponsor !re(1 & ! am\nt ( ! p5alty1     
settlem5t1 or paym5t impos$4  4  #e4    
,ext5sion ( au?ority to issue priority  
review v\*]s to enc\rage treatm5ts = r>e
 p$iatric diseases  7a7 ,ext5sion       
,p>agraph 7#e7 ( section #ebi7;b7 ( !   

,f$]al ,food1 ,drug1 & ,cosmetic ,act   
7#ba ,u4,s4,c4 #cfj;ff7b77 is am5d$ by  
/rik+ ,decemb] #bj1 #bjbd1 unless & all 
t foll[s ?r\gh ! p]iod at ! end & ins]t+
 ,septemb] #cj1 #bjbi44  7b7 ,us] fee   
paym5t ,section #ebi7;c77#d7 ( ! ,f$]al 
,food1 ,drug1 & ,cosmetic ,act 7#ba     
,u4,s4,c4 #cfj;ff7c77#d77 is am5d$ by   
/rik+ subp>agraph 7,a7 & ins]t+ !       
foll[+3  7,a7 ,9 g5]al ,! priority      
review us] fee requir$ by ?is subsection
 %all be due ^u ! submission ( a human  
drug application "u section #eje7;b77#a7
 or section #cea7;a7 ( ! ,public ,heal? 
,s]vice ,act = :i* ! priority review    
v\*] is us$4 ,all o!r us] fees associat$
 ) ! human drug application %all be due 
z requir$ by ! ,secret>y or "u          
applicable law4  4  7c7 ,,gao report on 
effectiv5ess ( r>e p$iatric disease     
priority v\*] aw>ds 9 inc5tiviz+ r>e    
p$iatric disease drug developm5t  7#a7  
,,gao /udy  7,a7 ,/udy ,! ,comptroll]   
,g5]al ( ! ,unit$ ,/ates %all conduct a 
/udy ( ! effectiv5ess ( aw>d+ r>e       

p$iatric disease priority v\*]s "u      
section #ebi ( ! ,f$]al ,food1 ,drug1 & 
,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;ff71 
z am5d$ by subsection 7a71 9 !          
developm5t ( human drug products t treat
 or prev5t r>e p$iatric diseases 7z     
def9$ 9 su* section #ebi74  7,b7        
,cont5ts ( /udy ,9 conduct+ ! /udy "u   
subp>agraph 7,a71 ! ,comptroll] ,g5]al  
%all exam9e ! foll[+3  7i7 ,!           
indications = ea* drug or biological    
product t-- 7,i7 is ! subject ( a r>e   
p$iatric disease product application 7z 
def9$ 9 section #ebi ( ! ,f$]al ,food1  
,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4  
#cfj;ff77 = :i* a priority review v\*] 0
 aw>d$2 &  7,,ii7 0 approv$ "u section  
#eje ( ! ,f$]al ,food1 ,drug1 &         
,cosmetic ,act 7#db ,u4,s4,c4 #cee7 or  
lic5s$ "u section #cea ( ! ,public      
,heal? ,s]vice ,act 7#db ,u4,s4,c4      
#bfb74  7ii7 ,:e!r1 & to :at ext5t1 an  
unmet ne$ relat$ to ! treatm5t or       
prev5tion ( a r>e p$iatric disease 0 met
 ?r\gh ! approval or lic5sure ( su* a   

drug or biological product4  7iii7 ,!   
size ( ! company to :i* a priority      
review v\*] 0 aw>d$ "u section #ebi ( ! 
,f$]al ,food1 ,drug1 & ,cosmetic ,act   
7#ba ,u4,s4,c4 #cfj;ff7 = su* a drug or 
biological product4  7iv7 ,! value ( su*
 priority review v\*] if transf]r$4  7v7
 ,id5tification ( ea* drug = :i* a      
priority review v\*] aw>d$ "u su*       
section #ebi 0 us$4  7vi7 ,! size ( !   
company us+ ea* priority review v\*]    
aw>d$ "u su* section #ebi4  7vii7 ,!    
l5g? ( ! p]iod ( "t betwe5 ! date on :i*
 a priority review v\*] 0 aw>d$ "u su*  
section #ebi & ! date on :i* x 0 us$4   
7viii7 ,:e!r1 & to :at ext5t1 an unmet  
ne$ relat$ to ! treatm5t or prev5tion ( 
a r>e p$iatric disease 0 met ?r\gh !    
approval "u section #eje ( ! ,f$]al     
,food1 ,drug1 & ,cosmetic ,act 7#db     
,u4,s4,c4 #cee7 or lic5sure "u section  
#cea ( ! ,public ,heal? ,s]vice ,act    
7#db ,u4,s4,c4 #bfb7 ( a drug = :i* a   
priority review v\*] 0 us$4  7ix7 ,:e!r1
 & to :at ext5t1 companies 7 motivat$ by

 ! availability ( priority review v\*]s 
"u section #ebi ( ! ,f$]al ,food1 ,drug1
 & ,cosmetic ,act 7#ba ,u4,s4,c4        
#cfj;ff7 to attempt to develop a drug = 
a r>e p$iatric disease4  7x7 ,:e!r1 & to
 :at ext5t1 p$iatric review v\*]s aw>d$ 
"u su* section 7 successful 9 /imulat+  
developm5t & exp$it$ pati5t access to   
drug products = treatm5t or prev5tion ( 
a r>e p$iatric disease t w\ldn't o!rwise
 take place )\t ! inc5tive provid$ by   
su* v\*]s4  7xi7 ,! impact ( su*        
priority review v\*]s on ! workload1    
review process1 & public heal?          
prioritization ef=ts ( ! ,food & ,drug  
,adm9i/ration4  7xii7 ,any o!r inc5tives
 9 ,f$]al law t exi/ = companies        
develop+ drugs or biological products   
describ$ 9 clause 7i74  7#b7 ,report on 
f9d+s ,n lat] ?an #e ye>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 ,labor1 &        

,p5sions ( ! ,s5ate a report conta9+ !  
f9d+s ( ! /udy conduct$ "u p>agraph     
7#a74  #f4 ,limitations on exclusive    
approval or lic5sure ( orphan drugs  7a7
 ,9 g5]al ,section #ebg ( ! ,f$]al      
,food1 ,drug1 & ,cosmetic ,act 7#ba     
,u4,s4,c4 #cfj;cc7 is am5d$--  7#a7 9   
subsection 7a71 9 ! matt] foll[+        
p>agraph 7#b71 by /rik+ same disease or 
condition & ins]t+ same approv$ use or  
indication )9 su* r>e disease or        
condition2  7#b7 9 subsection 7b7--     
7,a7 9 ! matt] prec$+ p>agraph 7#a71 by 
/rik+ same r>e disease or condition &   
ins]t+ same approv$ use or indication = 
:i* su* #g-ye> p]iod applies to su*     
already approv$ or lic5s$ drug2 &  7,b7 
9 p>agraph 7#a71 by ins]t+ 1 relat+ to !
 approv$ use or indication1 aft] ! ne$s2
  7#c7 9 subsection 7c77#a71 by /rik+   
same r>e disease or condition z !       
already approv$ drug & ins]t+ same use  
or indication = :i* ! already approv$ or
 lic5s$ drug 0 approv$ or lic5s$2 &     
7#d7 by add+ at ! end ! foll[+3  7f7    

,approv$ use or indication def9$ ,9 ?is 
section1 ! t]m approv$ use or indication
 means ! use or indication approv$ "u   
section #eje ( ?is ,act or lic5s$ "u    
section #cea ( ! ,public ,heal? ,s]vice 
,act = a drug designat$ "u section #ebf 
= a r>e disease or condition4  4  7b7   
,application ( am5dm5ts ,! am5dm5ts made
 by subsection 7a7 %all apply ) respect 
to any drug designat$ "u section #ebf ( 
! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 
7#ba ,u4,s4,c4 #cfj;bb71 reg>dless ( !  
date on :i* ! drug 0 s designat$1 &     
reg>dless ( ! date on :i* ! drug 0      
approv$ "u section #eje ( su* ,act 7#ba 
,u4,s4,c4 #cee7 or lic5s$ "u section    
#cea ( ! ,public ,heal? ,s]vice ,act    
7#db ,u4,s4,c4 #bfb74  #g4 ,program =   
p$iatric /udies ( drugs ,section        
#dji;,i7d77#a7 ( ! ,public ,heal?       
,s]vice ,act 7#db ,u4,s4,c4             
#bhdm7d77#a77 is am5d$ by /rik+ section1
 & all t foll[s ?r\gh ! p]iod at ! end &
 ins]t+ section1 #be1jjj1jjj = ea* (    
fiscal ye>s #bjbf ?r\gh #bjbh44  #h4    

,organ ,procurem5t & ,transplantation   
,network ,section #cgb ( ! ,public      
,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bgd7
 is am5d$--  7#a7 9 subsection 7b77#b7--
 7,a7 by mov+ ! m>g9s ( subp>agraphs    
7,m7 ?r\gh 7,o7 #b ems to ! left2  7,b7 
9 subp>agraph 7,a7-- 7i7 9 clause 7i71  
by /rik+ 1 & & ins]t+ 2 &2 &  7ii7 9    
clause 7ii71 by /rik+ ! comma at ! end &
 ins]t+ a semicolon2  7,c7 9 subp>agraph
 7,c71 by /rik+ tw5ty-f\r-h\r telephone 
s]vice & ins]t+ #bd-;h\r telephone or   
in=mation te*nology s]vice2  7,d7 9 ea* 
( subp>agraphs 7,b7 ?r\gh 7,m71 by /rik+
 ! comma at ! end & ins]t+ a semicolon2 
7,e7 9 subp>agraph 7,n71 by /rik+       
transportation1 & & ins]t+              
transportation22  7,f7 9 subp>agraph    
7,o71 by /rik+ ! p]iod & ins]t+ a       
semicolon2 &  7,g7 by add+ at ! end !   
foll[+3  7,p7 enc\rage ! integration (  
electronic heal? records sy/ems ?r\gh   
application programm+ int]faces 7or     
successor te*nologies7 among hospitals1 
organ procurem5t organizations1 &       

transplant c5t]s1 includ+ ! use (       
automat$ electronic hospital ref]rals & 
! grant ( remote1 electronic access to  
hospital electronic heal? records (     
pot5tial donors by organ procurem5t     
organizations1 9 a mann] t complies ) ! 
privacy regulations promulgat$ "u !     
,heal? ,insurance ,portability &        
,acc\ntability ,act ( #aiif1 at "p #afj 
( title #de1 ,code ( ,f$]al             
,regulations1 & subp>ts ,a1 ,c1 & ,e (  
"p #afd ( su* title 7or any successor   
regulations72 &  7,q7 consid] e/abli%+ a
 da%bo>d to display ! numb] (           
transplants p]=m$1 ! types ( transplants
 p]=m$1 ! numb] & types ( organs t ent]$
 ! ,organ ,procurem5t & ,transplantation
 ,network sy/em & fail$ to be           
transplant$1 & o!r appropriate /ati/ics1
 :i* %\ld be updat$ m frequ5tly ?an     
annually4  2 &  7#b7 by add+ at ! end ! 
foll[+3  7d7 ,regi/ration fees  7#a7 ,9 
g5]al ,! ,secret>y may collect          
regi/ration fees f any memb] ( ! ,organ 
,procurem5t & ,transplantation ,network 

= ea* transplant c&idate su* memb]      
places on ! li/ describ$ 9 subsection   
7b77#b77;,a77i74 ,su* regi/ration fees  
%all be collect$ & di/ribut$ only to    
support ! op]ation ( ! ,organ           
,procurem5t & ,transplantation ,network4
 ,su* regi/ration fees are au?oriz$ to  
rema9 available until exp5d$4  7#b7     
,collection ,! ,secret>y may collect !  
regi/ration fees "u p>agraph 7#a7       
directly or ?r\gh aw>ds made "u         
subsection 7b77#a77;,a74  7#c7          
,di/ribution ,any am\nts collect$ "u ?is
 subsection %all--  7,a7 be cr$it$ to ! 
curr5tly applicable appropriation1      
acc\nt1 or fund ( ! ,dep>tm5t ( ,heal? &
 ,human ,s]vices z discretion>y (fsett+ 
collections2 &  7,b7 be available1 only 
to ! ext5t & 9 ! am\nts provid$ 9       
advance 9 appropriations ,acts1 to      
di/ribute su* fees among aw>dees        
describ$ 9 subsection 7b77#a77;,a74     
7#d7 ,transp>5cy ,! ,secret>y %all--    
7,a7 promptly po/ on ! website ( !      
,organ ,procurem5t & ,transplantation   

,network--  7i7 ! am\nt ( regi/ration   
fees collect$ "u ?is subsection f ea*   
memb] ( ! ,organ ,procurem5t &          
,transplantation ,network2 &  7ii7 a li/
 ( activities su* fees are us$ to       
support2 &  7,b7 update ! in=mation po/$
 pursuant to subp>agraph 7,a71 z        
applicable = ea* cal5d> qu>t] = :i* fees
 are collect$ "u p>agraph 7#a74  7#e7   
,,gao review ,n lat] ?an #b ye>s aft] ! 
date ( enactm5t ( ?is subsection1 !     
,comptroll] ,g5]al ( ! ,unit$ ,/ates    
%all1 to ! ext5t data are available--   
7,a7 conduct a review conc]n+ !         
activities "u ?is subsection2 &  7,b7   
submit to ! ,committee on ,heal?1       
,education1 ,labor1 & ,p5sions & !      
,committee on ,f9ance ( ! ,s5ate & !    
,committee on ,en]gy & ,comm]ce ( !     
,h\se ( ,repres5tatives1 a report on su*
 review1 includ+ relat$ recomm5dations1 
z applicable4  7#f7 ,sunset ,! au?ority 
to collect regi/ration fees "u p>agraph 
7#a7 %all expire on ! date t is #c ye>s 
aft] ! date ( enactm5t ( ! ,mikaela     

,naylon ,give ,kids a ,*ance ,act4  4   
#i4 ,e/abli%m5t ( ,abraham ,accords     
,(fice )9 ,food & ,drug ,adm9i/ration   
7a7 ,9 g5]al ,*apt] ,x ( ! ,f$]al ,food1
 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 
#cia et seq47 is am5d$ by add+ at ! end 
! foll[+3  #ajae4 ,abraham ,accords     
,(fice  7a7 ,9 g5]al ,! ,secret>y1 act+ 
?r\gh ! ,commission] ( ,food & ,drugs1  
%all e/abli% )9 ! ,food & ,drug         
,adm9i/ration an (fice1 to be kn[n z !  
,abraham ,accords ,(fice1 to be head$ by
 a director4  7b7 ,(fice ,n lat] ?an two
 ye>s aft] ! date ( enactm5t ( ?is      
section1 ! ,secret>y %all--  7#a7 9     
consultation ) ! gov]nm5ts ( ,abraham   
,accords c\ntries1 z well z appropriate 
,unit$ ,/ates ,gov]nm5t diplomatic &    
security p]sonnel-- 7,a7 select !       
location ( ! ,abraham ,accords ,(fice 9 
an ,abraham ,accords c\ntry2 &  7,b7    
e/abli% su* (fice2 &  7#b7 assign to su*
 (fice su* p]sonnel ( ! ,food & ,drug   
,adm9i/ration z ! ,secret>y det]m9es    
necess>y to c>ry out ! functions ( su*  

(fice4  7c7 ,duties ,! ,secret>y1 act+  
?r\gh ! ,director ( ! ,abraham ,accords 
,(fice1 %all-- 7#a7 aft] ! ,abraham     
,accords ,(fice is e/abli%$--  7,a7 z "p
 ( ! ,food & ,drug ,adm9i/ration's "w to
 /r5g!n ! int]national ov]sight (       
regulat$ commodities1 provide te*nical  
assi/ance to regulatory p>tn]s 9        
,abraham ,accords c\ntries on /r5g!n+   
regulatory ov]sight & conv]g+ regulatory
 requirem5ts = ! ov]sight ( regulat$    
products1 includ+ good manufactur+      
practices & o!r issues relevant to      
manufactur+ m$ical products t are       
regulat$ by ! ,food & ,drug             
,adm9i/ration2 &  7,b7 facilitate       
int]actions betwe5 ! ,food & ,drug      
,adm9i/ration & int]e/$ p>ties 9        
,abraham ,accords c\ntries1 includ+ by  
%>+ relevant in=mation reg>d+ ,unit$    
,/ates regulatory pa?ways ) su* p>ties1 
& facilitate fe$back on ! rese>*1       
developm5t1 & manufactur+ ( products    
regulat$ 9 accordance ) ?is ,act2 &     
7#b7 c>ry out o!r functions & activities

 z ! ,secret>y det]m9es to be necess>y  
to c>ry out ?is section4  7d7 ,abraham  
,accords c\ntry def9$ ,9 ?is section1 ! 
t]m ,abraham ,accords c\ntry means a    
c\ntry id5tifi$ by ! ,dep>tm5t ( ,/ate z
 hav+ sign$ ! ,abraham ,accords         
,decl>ation4  7e7 ,national security    
,no?+ 9 ?is section %all be con/ru$ to  
require any action inconsi/5t ) a       
national security recomm5dation provid$ 
by ! ,f$]al ,gov]nm5t4  4  7b7 ,report  
to ,congress  7#a7 ,9 g5]al ,n lat] ?an 
#c ye>s aft] ! date ( enactm5t ( ?is    
,act1 ! ,secret>y ( ,heal? & ,human     
,s]vices %all submit to ! ,congress a   
report on ! ,abraham ,accords ,(fice1   
includ+--  7,a7 an evaluation ( h[ !    
,(fice has advanc$ progress t[>d        
con=mance ) ,food & ,drug ,adm9i/ration 
regulatory requirem5ts by manufactur]s 9
 ! ,abraham ,accords c\ntries2  7,b7 a  
num]ical c\nt ( p>ties t ! ,(fice has   
help$ facilitate int]actions or fe$back 
pursuant to section #ajae7;c77#a77;,b7 (
 ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act

 7z add$ by subsection 7a772  7,c7 a    
summ>y ( te*nical assi/ance provid$ to  
regulatory p>tn]s 9 ,abraham ,accords   
c\ntries pursuant to subp>agraph 7,a7 ( 
su* section #ajae7;c77#a72 &  7,d7      
recomm5dations = increas+ & improv+     
coord9ation betwe5 ! ,food & ,drug      
,adm9i/ration & entities 9 ,abraham     
,accords c\ntries4  7#b7 ,abraham       
,accords c\ntry def9$ ,9 ?is subsection1
 ! t]m ,abraham ,accords c\ntry has !   
mean+ giv5 su* t]m 9 section #ajae7;d7 (
 ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act
 7z add$ by subsection 7a774  #aj4      
,increas+ transp>5cy 9 g5]ic drug       
applications  7a7 ,9 g5]al ,section     
#eje7;j77#c7 ( ! ,f$]al ,food1 ,drug1 & 
,cosmetic ,act 7#ba ,u4,s4,c4           
#cee7;j77#c77 is am5d$ by add+ at ! end 
! foll[+3  7,h7  7i7 ,^u reque/ 79      
controll$ correspond5ce or an analog\s  
process7 by a p]son t has submitt$ or   
int5ds to submit an abbreviat$          
application "u ?is subsection = a drug t
 is requir$ by regulation to conta9 "o  

or m ( ! same inactive +r$i5ts 9 ! same 
conc5trations z ! li/$ drug ref]r$ to1  
or = :i* ! ,secret>y det]m9es !re is a  
sci5tific ju/ification = an approa* t is
 9 vitro1 9 :ole or 9 "p1 to be us$ to  
demon/rate bioequival5ce = a drug if su*
 a drug conta9s "o or m ( ! same        
inactive +r$i5ts 9 ! same conc5trations 
z ! li/$ drug ref]r$ to1 ! ,secret>y    
%all in=m ! p]son :e!r su* drug is      
qualitatively & quantitatively ! same z 
! li/$ drug4 ,! ,secret>y may also      
provide su* in=mation to su* a p]son on 
! ,secret>y's own initiative dur+ !     
review ( an abbreviat$ application "u   
?is subsection = su* drug4  7ii7        
,not)/&+ section #cja7;j71 if !         
,secret>y det]m9es t su* drug is n      
qualitatively or quantitatively ! same z
 ! li/$ drug1 ! ,secret>y %all id5tify &
 disclose to ! p]son--  7,i7 ! +r$i5t or
 +r$i5ts t cause su* drug n to be       
qualitatively or quantitatively ! same z
 ! li/$ drug2 &  7,,ii7 = any +r$i5t =  
:i* !re is an id5tifi$ quantitative     

deviation1 ! am\nt ( su* deviation4     
7iii7 ,if ! ,secret>y det]m9es t su*    
drug is qualitatively & quantitatively !
 same z ! li/$ drug1 ! ,secret>y %all n 
*ange or resc9d su* det]m9ation aft] !  
submission ( an abbreviat$ application =
 su* drug "u ?is subsection unless--    
7,i7 ! =mulation ( ! li/$ drug has be5  
*ang$ & ! ,secret>y has det]m9$ t !     
prior li/$ drug =mulation 0 )drawn =    
reasons ( safety or effectiv5ess2 or    
7,,ii7 ! ,secret>y makes a writt5       
det]m9ation t ! prior det]m9ation mu/ be
 *ang$ because an error has be5         
id5tifi$4  7iv7 ,if ! ,secret>y makes a 
writt5 det]m9ation describ$ 9 clause    
7iii77,,ii71 ! ,secret>y %all provide   
notice & a copy ( ! writt5 det]m9ation  
to ! p]son mak+ ! reque/ "u clause 7i74 
7v7 ,! disclosures au?oriz$ "u clauses  
7i7 & 7ii7 are disclosures au?oriz$ by  
law1 includ+ = purposes ( section #aije 
( title #ah1 ,unit$ ,/ates ,code4 ,?is  
subp>agraph %all n o!rwise be con/ru$ to
 au?orize ! disclosure ( nonpublic      

qualitative or quantitative in=mation   
ab\t ! +r$i5ts 9 a li/$ drug1 or to     
affect ! /atus1 if any1 ( su* in=mation 
z trade secret or confid5tial comm]cial 
in=mation = purposes ( section #cja7;j7 
( ?is ,act1 section #eeb ( title #e1    
,unit$ ,/ates ,code1 or section #aije ( 
title #ah1 ,unit$ ,/ates ,code4  4  7b7 
,guidance  7#a7 ,9 g5]al ,n lat] ?an "o 
ye> aft] ! date ( enactm5t ( ?is ,act1 !
 ,secret>y ( ,heal? & ,human ,s]vices   
%all issue draft guidance1 or update    
guidance1 describ+ h[ ! ,secret>y w     
det]m9e :e!r a drug is qualitatively &  
quantitatively ! same z ! li/$ drug 7z  
su* t]ms are us$ 9 section              
#eje7;j77#c77;,h7 ( ! ,f$]al ,food1     
,drug1 & ,cosmetic ,act1 z add$ by      
subsection 7a771 includ+ ) respect to   
assess+ p,h adju/]s4  7#b7 ,process ,9  
issu+ guidance "u ?is subsection1 !     
,secret>y ( ,heal? & ,human ,s]vices    
%all-- 7,a7 publi% draft guidance2  7,b7
 provide a p]iod ( at lea/ #fj days =   
comm5t on ! draft guidance2 &  7,c7 aft]

 consid]+ any comm5ts receiv$ & n lat]  
?an "o ye> aft] ! close ( ! comm5t p]iod
 on ! draft guidance1 publi% f9al       
guidance4  7c7 ,applicability ,section  
#eje7;j77#c77;,h7 ( ! ,f$]al ,food1     
,drug1 & ,cosmetic ,act1 z add$ by      
subsection 7a71 applies beg9n+ on ! date
 ( enactm5t ( ?is ,act1 irrespective ( !
 date on :i* ! guidance requir$ by      
subsection 7b7 is f9aliz$4  #aa4 ,m$ic>e
 ,improvem5t ,fund ,section             
#ahih7;b77#a7 ( ! ,social ,security ,act
 7#db ,u4,s4,c4 #acie;iii7b77#a77 is    
am5d$ by /rik+ #a1djc1jjj1jjj & ins]t+  
#b1fbb1jjj1jjj4  ,pass$ ! ,h\se (       
,repres5tatives ,decemb] #a1            
#bjbe4;,cl]k4