,,ii  #aag? ,,congress  #b;d ,session   
,s4 #djcg  ,,9 ,,! ,,s5ate ,,( ,,!      
,,unit$ ,,/ates  ,april #g1 #bjbb,ms4   
,/ab5[ 7= h]self & ,ms4 ,smi?7 introduc$
 ! foll[+ bill2 :i* 0 read twice &      
ref]r$ to ! ,committee on ,heal?1       
,education1 ,labor1 & ,p5sions  ,a      
,,bill  ,to am5d ! ,public ,heal?       
,s]vice ,act to increase ! transp>5cy ( 
ph>maceutical rese>* co/s1 & = o!r      
purposes4  #a4 ,%ort title ,?is ,act may
 be cit$ z ! ,ph>maceutical ,rese>*     
,transp>5cy ,act ( #bjbb4  #b4          
,expansion ( regi/ry & results data bank
 to include co/s ( drug cl9ical trials  
7a7 ,9 g5]al ,section #djb7;j7 ( !      
,public ,heal? ,s]vice ,act 7#db        
,u4,s4,c4 #bhb7;j77 is am5d$-- 7#a7 by  
r$esignat+ p>agraph 7#g7 z p>agraph     
7#h72 &  7#b7 by ins]t+ aft] p>agraph   
7#f7 ! foll[+ new p>agraph3  7#g7       
,creation ( cl9ical trial co/ data      
repository  7,a7 ,g5]ally ,! ,secret>y1 
act+ ?r\gh ! ,director ( ,,nih1 %all    
create a publicly available ,f$]al      

website to s]ve z a repository ( co/    
data = all applicable drug cl9ical      
trials 79 ?is p>agraph ref]r$ to z ! co/
 data repository74 ,su* repository %all 
be se>*able by ! foll[+ crit]ia3 7i7 ,! 
responsible p>ty or sponsor ( !         
applicable drug cl9ical trial1 or any   
entity fund+ ! applicable drug cl9ical  
trial4  7ii7 ,! "n ( ! int]v5tion1      
includ+ any drug be+ /udi$ 9 !          
applicable drug cl9ical trial4  7iii7 ,!
 /udy phase ( ! applicable drug cl9ical 
trial4  7iv7 ,! />t date & completion   
date ( ! applicable drug cl9ical trial4 
7v7 ,su* o!r crit]ia z ! ,secret>y deems
 appropriate4  7,b7 ,co/ data def9$ ,=  
purposes ( ?is p>agraph1 ! t]m co/ data 
includes ! foll[+ in=mation3 7i7 ,!     
total co/ ( ! applicable drug cl9ical   
trial4  7ii7 ,! co/ ( ! trial p] pati5t4
  7iii7 ,exp5ditures = ea* ( ! foll[+   
categories3 7,i7 ,p]sonnel4  7,,ii7 ,any
 int]v5tion or treatm5t t is adm9i/]$ 9 
"o or m arms ( ! applicable drug cl9ical
 trial4  7,,iii7 ,mat]ials & supplies4  

7,,iv7 ,heal? c>e s]vices provid$ to    
subjects4  7,v7 ,site managem5t4  7,,vi7
 ,laboratory4  7,,vii7 ,equipm5t4       
7,,viii7 ,! allocable portion ( any     
facilities co/s1 adm9i/rative co/s1 or  
o!r co/s t are n solely attributable to 
! applicable drug cl9ical trial4  7,,ix7
 ,su* o!r categories z ! ,secret>y may  
id5tify by regulation4  7,c7 ,po/+ (    
cl9ical trial co/ data  7i7 ,9 g5]al    
,except z provid$ 9 clause 7iii71 ea*   
responsible p>ty ( an applicable drug   
cl9ical trial %all po/ co/ data = t     
trial to ! co/ data repository no lat]  
?an #a ye> aft] ! completion date ( !   
trial4  7ii7 ,=mat & me?odology ( po/+  
,a co/ data po/+ "u clause 7i7 %all--   
7,i7 include individual data po9ts = !  
in=mation requir$ "u subp>agraphs       
7,b77i7 & 7,b77ii71 sep>at$ by ye>2     
7,,ii7 include individual data po9ts =  
ea* category li/$ "u subp>agraph        
7,b77iii71 sep>at$ by ye>2  7,,iii7     
limit ! co/ ( ! int]v5tion or treatm5t  
"u subp>agraph 7,b77iii77,,ii7 to       

manufactur+ co/s unless ! responsible   
p>ty ( ! trial 0 requir$ to pur*ase !   
int]v5tion or treatm5t f an unaffiliat$ 
?ird p>ty2  7,,iv7 include detail$      
docum5tation & me?odology = !           
calculation ( co/s id5tifi$ "u          
subp>agraph 7,b77iii77,,viii72 &  7,v7  
include a sign$ c]tification t ! po/$   
data is complete & accurate4  7iii7     
,delay$ po/+ ( co/ data & ext5sions     
7,i7 ,seek+ initial approval ( drug1 or 
approval ( a new use ,if ! responsible  
p>ty = an applicable drug cl9ical trial 
submits a c]tification t p>agraph       
7#c77;,e77iv7 or p>agraph 7#c77;,e77v7  
applies to su* trial1 ! responsible p>ty
 %all po/ co/ data "u clause 7i7 at ! "t
 t cl9ical trial in=mation is requir$ to
 be submitt$ "u ! applicable p>agraph4  
7,,ii7 ,ext5sion = good cause ,!        
,director ( ,,nih may provide an        
ext5sion ( ! deadl9e = po/+ ( co/ data  
"u clause 7i7 if ! responsible p>ty = ! 
trial submits to ! ,director a writt5   
reque/ t demon/rates good cause = !     

ext5sion & provides an e/imate ( ! date 
on :i* ! in=mation w be po/$4 ,!        
,director ( ,,nih may grant m ?an "o su*
 ext5sion = a cl9ical trial1 b "u no    
circum/ances %all an ext5sion "u ?is    
subclause ext5d beyond ! date t is #ah  
mon?s aft] ! completion date ( ! trial4 
7,,iii7 ,ext5sion to e/abli% necess>y   
infra/ructure ,if necess>y to e/abli% ! 
necess>y infra/ructure to accept1       
organize1 & po/ co/ data submitt$ "u    
clause 7i71 ! ,director ( ,,nih may     
ext5d ! deadl9e = ! po/+ ( co/ data "u  
clause 7i7 to n lat] ?an #b ye>s aft] ! 
date ( enactm5t ( ! ,ph>maceutical      
,rese>* ,transp>5cy ,act ( #bjbb4       
7,,iv7 ,rule ( con/ruction ,?is clause  
%all n be con/ru$ to h any effect on    
report+ obligations ( ! responsible p>ty
 "u provisions o!r ?an ?is p>agraph4    
7,d7 ,l9k+ to co/ data repository  7i7  
,creation ( field ,! ,director ( ,,nih  
%all create a field )9 ! regi/ry &      
results data bank to include an         
electronic l9k to ! relevant co/ data   

po/+ "u subp>agraph 7,c77i74  7ii7 ,po/+
 ,! responsible p>ty = an applicable    
drug cl9ical trial %all po/ 9 ! field   
creat$ "u clause 7i7 a l9k to ! relevant
 co/ data po/+ no lat] ?an #e days aft] 
initial po/+ ( ! co/ data "u subp>agraph
 7,c77i74  7,e7 ,rulemak+  7i7 ,9 g5]al 
,! ,secret>y %all promulgate regulations
 to c>ry out ?is p>agraph t include--   
7,i7 def9itions = ea* category (        
in=mation id5tifi$ 9 subp>agraph 7,b72  
7,,ii7 /&>ds = allocat+ fix$ exp5ditures
 across multiple ye>s ( an applicable   
drug cl9ical trial2  7,,iii7 a /&>d =mat
 = ! submission & po/+ ( co/ data "u ?is
 p>agraph2  7,,iv7 proc$ures1 /&>ds1 &  
requirem5ts = ! report+ docum5tation &  
me?odology requir$ "u subp>agraph       
7,c77ii77,,iv72 &  7,v7 any o!r         
proc$ures1 /&>ds1 or requirem5ts        
necess>y to ensure public transp>5cy (  
co/ data z requir$ by ?is p>agraph4     
7ii7 ,initial regulations ,! ,secret>y  
%all-- 7,i7 n lat] ?an "o ye> aft] !    
date ( enactm5t ( ! ,ph>maceutical      

,rese>* ,transp>5cy ,act ( #bjbb1       
propose initial regulations "u clause   
7i72 &  7,,ii7 n lat] ?an #b ye>s aft]  
su* date ( enactm5t1 f9alize su*        
regulations4  7,f7 ,applicability ,!    
requirem5ts ( ?is p>agraph apply only to
 applicable drug cl9ical trials ) a />t 
date on or aft] ! date ( enactm5t ( !   
,ph>maceutical ,rese>* ,transp>5cy ,act 
( #bjbb4  4  7b7 ,con=m+ *anges ,section
 #djb7;j7 ( ! ,public ,heal? ,s]vice    
,act 7#db ,u4,s4,c4 #bhb7;j771 z am5d$  
by subsection 7a71 is fur!r am5d$-- 7#a7
 9 p>agraph 7#a77;,a77iv71 by /rik+     
p>agraph 7#b7 or "u p>agraph 7#c7 &     
ins]t+ p>agraph 7#b71 7#c71 or 7#g72    
7#b7 9 p>agraph 7#d7-- 7,a7 9           
subp>agraph 7,a71 by /rik+ p>agraph 7#b7
 or p>agraph 7#c7 & ins]t+ p>agraph     
7#b71 7#c71 or 7#g72 &  7,b7 9          
subp>agraph 7,b77i71 by /rik+ p>agraphs 
7#b7 & 7#c7 ea* place x appe>s & ins]t+ 
p>agraphs 7#b71 7#c71 & 7#g72 &  7#c7 9 
p>agraph 7#e7-- 7,a7 9 subp>agraph 7,a71
 by /rik+ p>agraphs 7#b7 & 7#c7 ea*     

place x appe>s & ins]t+ p>agraphs 7#b71 
7#c71 & 7#g72 &  7,b7 9 subp>agraph     
7,e77i71 by /rik+ p>agraphs 7#b7 or 7#c7
 & ins]t+ p>agraph 7#b71 7#c71 or 7#g74 
#c4 ,disclosure ( rese>* & developm5t   
exp5ditures by drug manufactur]s        
,section #ac ( ! ,securities ,ex*ange   
,act ( #aicd 7#ae ,u4,s4,c4 #ghm7 is    
am5d$ by add+ at ! end ! foll[+3  7s7   
,disclosure ( rese>* & developm5t       
exp5ditures by drug manufactur]s  7#a7  
,def9itions ,9 ?is subsection3 7,a7     
,drug ,! t]m drug means any product =   
:i* "o or m compon5ts h be5 ! subject ( 
any ( ! foll[+ applications fil$ ) !    
,food & ,drug ,adm9i/ration3 7i7 ,a new 
drug application 7or supplem5tal new    
drug application7 fil$ "u subsection 7b7
 or 7j7 ( section #eje ( ! ,f$]al ,food1
 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 
#cee74  7ii7 ,a biologic product        
application 7or supplem5tal application7
 fil$ "u subsection 7a7 or 7k7 ( section
 #cea ( ! ,public ,heal? ,s]vice ,act   
7#db ,u4,s4,c4 #bfb74  7,b7 ,drug       

manufactur] issu] ,! t]m drug           
manufactur] issu] means an issu] t-- 7i7
 is requir$ to file an annual report ) !
 ,commission "u subsection 7a72 &  7ii7 
engages 9 ! developm5t1 manufacture1 or 
m>ket+ ( any drug4  7#b7 ,disclosure    
7,a7 ,9 g5]al ,subject to ! o!r         
provisions ( ?is p>agraph1 ! ,commission
 %all issue rules t require ea* drug    
manufactur] issu]'s annual report "u    
subsection 7a7 to include in=mation     
reg>d+ ! drug manufactur] issu]'s rese>*
 & developm5t exp5ditures ) respect to--
 7i7 a drug2 &  7ii7 any prelim9>y      
rese>* or developm5t ( a drug product or
 drug sub/ance1 z ^? t]ms are def9$ 9   
section #cad4c ( title #ba1 ,code (     
,f$]al ,regulations 7or any successor   
regulation7 = :i* ! drug manufactur]    
issu] has n submitt$ an application     
describ$ 9 clause 7i7 or 7ii7 ( p>agraph
 7#a77;,a74  7,b7 ,initial rules ,!     
,commission %all-- 7i7 n lat] ?an #a ye>
 aft] ! date ( enactm5t ( !             
,ph>maceutical ,rese>* ,transp>5cy ,act 

( #bjbb1 propose initial rules "u       
subp>agraph 7,a72 &  7ii7 n lat] ?an #b 
ye>s aft] ! date ( enactm5t describ$ 9  
clause 7i71 f9alize ! rules requir$ "u  
subp>agraph 7,a74  7,c7 ,requir$        
in=mation ,! in=mation requir$ "u       
subp>agraph 7,a7 %all include total     
exp5ditures1 :i* %all be disaggregat$ to
 ea* /age ( drug rese>* & developm5t1   
includ+-- 7i7 basic rese>*2  7ii7       
pre-cl9ical rese>*2  7iii7 phase ,i ( a 
cl9ical inve/igation ( a new drug1 z    
describ$ 9 section #cab4ba7;a7 ( title  
#ba1 ,code ( ,f$]al ,regulations1 or any
 successor regulation2  7iv7 phase ,,ii 
( a cl9ical inve/igation ( a new drug1 z
 describ$ 9 section #cab4ba7;b7 ( title 
#ba1 ,code ( ,f$]al ,regulations1 or any
 successor regulation2  7v7 phase ,,iii 
( a cl9ical inve/igation ( a new drug1 z
 describ$ 9 section #cab4ba7;c7 ( title 
#ba1 ,code ( ,f$]al ,regulations1 or any
 successor regulation2 &  7vi7 po/-m>ket
 /udies or cl9ical trials requir$ "u    
section #eje7o7 ( ! ,f$]al ,food1 ,drug1

 & ,cosmetic ,act 7#ba ,u4,s4,c4        
#cee7o774  7,d7 ,limitations calculation
 ,! calculation ( exp5diture in=mation  
disclos$ "u subp>agraph 7,a7 %all n     
include ! foll[+ in=mation1 al?\gh su*  
in=mation may be disclos$ sep>ately3 7i7
 ,co/s incurr$ 9 connection ) lic5s+    
agreem5ts or acquir+ intellectual       
prop]ty4  7ii7 ,! co/ ( m]g]s or        
acquisitions4  7iii7 ,any intangible    
co/s1 includ+ e/imates1 adju/m5ts1 &    
assumptions relat$ to ! risk ( failure1 
or ! risk associat$ ) seek+ regulatory  
approval by ! ,food & ,drug             
,adm9i/ration or ano!r ag5cy4  7iv7 ,!  
e/imat$ co/ ( capital4  7#c7            
,consultation 9 rulemak+ ,9 issu+ rules 
"u ?is subsection1 ! ,commission-- 7,a7 
%all consult ) ! ,commission] ( ,food & 
,drugs & ! ,director ( ! ,national      
,in/itutes ( ,heal?2 &  7,b7 may consult
 ) ! head ( any o!r ,f$]al ag5cy or     
entity t ! ,commission det]m9es is      
relevant4  4  #d4 ,sev]ability ,if any  
provision ( ?is ,act1 an am5dm5t made by

 ?is ,act1 or ! application ( any su*   
provision or am5dm5t to any p]son or    
circum/ance is held to be               
uncon/itutional1 ! rema9d] ( !          
provisions ( ?is ,act1 ! am5dm5ts made  
by ?is ,act1 & ! application ( su*      
provisions & am5dm5ts to any p]son or   
circum/ance %all n be affect$ !reby4