,i  #aad? ,,congress  #a/ ,session  ,h4 
,r4 #bdae  ,,9 ,,! ,,h\se ,,(           
,,repres5tatives  ,may #ai1 #bjae ,mr4  
,burgess 7= himself & ,mr4 ,engel7      
introduc$ ! foll[+ bill2 :i* 0 ref]r$ to
 ! ,committee on ,en]gy & ,comm]ce  ,a  
,,bill  ,to am5d ! ,f$]al ,food1 ,drug1 
& ,cosmetic ,act to provide = e/abli%m5t
 ( a /reaml9$ data review program4  #a4 
,/reaml9$ data review program  7a7 ,9   
g5]al ,*apt] ,v ( ! ,f$]al ,food1 ,drug1
 & ,cosmetic ,act is am5d$ by ins]t+    
aft] section #eje;,f ( su* ,act 7#ba    
,u4,s4,c4 #cee;f7 ! foll[+3  #eje;,f4   
,/reaml9$ data review program  7a7 ,9   
g5]al ,! ,secret>y %all e/abli% a       
/reaml9$ data review program "u :i* a   
hold] ( an approv$ application submitt$ 
"u section #eje7;b77#a7 or "u section   
#cea7;a7 ( ! ,public ,heal? ,s]vice ,act
 may1 to support ! approval or lic5sure 
7z applicable7 ( ! use ( ! drug t is !  
subject ( su* approv$ application = a   
new qualifi$ indication1 submit qualifi$
 data summ>ies4  7b7 ,eligibility ,9    

c>ry+ out ! /reaml9$ data review program
 "u subsection 7a71 ! ,secret>y may     
au?orize ! hold] ( ! approv$ application
 to include "o or m qualifi$ data       
summ>ies describ$ 9 subsection 7a7 9 a  
supplem5tal application if--  7#a7 !    
drug has be5 approv$ "u section #eje7;c7
 ( ?is ,act or lic5s$ "u section        
#cea7;a7 ( ! ,public ,heal? ,s]vice ,act
 = "o or m indications1 & su* approval  
or lic5sure rema9s 9 effect2  7#b7 !    
supplem5tal application is = approval or
 lic5sure 7z applicable7 "u su* section 
#eje7;c7 or #cea7;a7 ( ! use ( ! drug = 
a new qualifi$ indication "u su* section
 #eje7;c7 or #cea7;a72  7#c7 !re is an  
exi/+ database acceptable to ! ,secret>y
 reg>d+ ! safety ( ! drug develop$ = "o 
or m indications ( ! drug approv$ "u su*
 section #eje7;c7 or lic5s$ "u su*      
section #cea7;a72  7#d7 ! supplem5tal   
application incorporates or supplem5ts !
 data submitt$ 9 ! application =        
approval or lic5sure ref]r$ to 9        
p>agraph 7#a72 &  7#e7 ! full data sets 

us$ to develop ! qualifi$ data summ>ies 
are submitt$1 unless ! ,secret>y        
det]m9es t ! full data sets are n       
requir$4  7c7 ,public availability (    
in=mation on program ,! ,secret>y %all  
po/ on ! public website ( ! ,food &     
,drug ,adm9i/ration & update annually-- 
7#a7 ! numb] ( applications review$ "u !
 /reaml9$ data review program2  7#b7 !  
av]age "t = completion ( review "u !    
/reaml9$ data review program v]sus o!r  
review ( applications = new indications2
 &  7#c7 ! numb] ( applications review$ 
"u ! /reaml9$ data review program = :i* 
! ,food & ,drug ,adm9i/ration made use (
 full data sets 9 addition to ! qualifi$
 data summ>y4  7d7 ,def9itions ,9 ?is   
section3 7#a7 ,! t]m qualifi$ indication
 means--  7,a7 an indication = !        
treatm5t ( canc]1 z det]m9$ appropriate 
by ! ,secret>y2 or  7,b7 su* o!r types (
 indications z ! ,secret>y det]m9es to  
be subject to ! /reaml9$ data review    
program "u ?is section4  7#b7 ,! t]m    
qualifi$ data summ>y means a summ>y (   

cl9ical data int5d$ to demon/rate safety
 & effectiv5ess ) respect to a qualifi$ 
indication = use ( a drug4  4  7b7 ,s5se
 ( ,congress ,x is ! s5se ( ,congress t 
! /reaml9$ data review program "u       
section #eje;,f ( ! ,f$]al ,food1 ,drug1
 & ,cosmetic ,act1 z add$ by subsection 
7a71 %\ld enable ! ,food & ,drug        
,adm9i/ration to make approval decisions
 = c]ta9 supplem5tal applications bas$  
on qualifi$ data summ>ies 7z def9$ 9 su*
 section #eje;,f74  7c7 ,guidance2      
regulations ,! ,commission] ( ,food &   
,drugs-- 7#a7 %all--  7,a7 issue f9al   
guidance = implem5tation ( ! /reaml9$   
data review program e/abli%$ "u section 
#eje;,f ( ! ,f$]al ,food1 ,drug1 &      
,cosmetic ,act1 z add$ by subsection    
7a71 n lat] ?an #bd mon?s aft] ! date ( 
enactm5t ( ?is ,act2 &  7,b7 include 9  
su* guidance ! process = exp&+ ! types (
 indications to be subject to ! /reaml9$
 data review program1 z au?oriz$ by     
section #eje;,f7c77#a77;,b7 ( su* ,act2 
&  7#b7 9 addition to issu+ guidance "u 

p>agraph 7#a71 may issue su* regulations
 z may be necess>y = implem5tation ( !  
program4