,i  #aac? ,,congress  #a/ ,session  ,h4 
,r4 #bjca  ,,9 ,,! ,,h\se ,,(           
,,repres5tatives  ,may #af1 #bjac ,mr4  
,m>key 7= himself1 ,mr4 ,waxman1 ,ms4   
,de,lauro1 & ,ms4 ,s*ak[sky7 introduc$ !
 foll[+ bill2 :i* 0 ref]r$ to !         
,committee on ,en]gy & ,comm]ce  ,a     
,,bill  ,to am5d title ,,iv ( ! ,public 
,heal? ,s]vice ,act to exp& ! cl9ical   
trial regi/ry data bank1 & = o!r        
purposes4  #a4 ,%ort title ,?is ,act may
 be cit$ z ! ,trial & ,exp]im5tal       
,/udies ,transp>5cy ,act ( #bjab or !   
,,te/ ,act4  #b4 ,exp&$ cl9ical trial   
regi/ry data bank  7a7 ,9 g5]al ,section
 #djb7;j7 ( ! ,public ,heal? ,s]vice    
,act 7#db ,u4,s4,c4 #bhb7;j77 is am5d$--
  7#a7 9 p>agraph 7#a77;,a7--  7,a7 9   
clause 7ii7--  7i7 by am5d+ subclause   
7,i7 to read z foll[s3  7,i7 an         
int]v5tional /udy ( a device subject to 
section #eaj7k71 #eae1 or #ebj7m7 ( !   
,f$]al ,food1 ,drug1 & ,cosmetic ,act1  
includ+ any int]v5tional /udy ( a device
 conduct$ outside ( ! ,unit$ ,/ates !   

results ( :i* are submitt$ to !         
,secret>y 9 support ( a ,,pma 7z su* t]m
 is def9$ 9 section #had4c7;e7 ( title  
#ba1 ,code ( ,f$]al ,regulations72 a    
prem>ket notification requir$ "u section
 #eaj7k7 ( ! ,f$]al ,food1 ,drug1 &     
,cosmetic ,act2 or a ,,hde 7z su* t]m is
 def9$ 9 section #had4c7m7 ( title #ba1 
,code ( ,f$]al ,regulations74  2 &  7ii7
 9 subclause 7,,ii7--  7,i7 by /rik+    
p$iatric2 &  7,,ii7 by ins]t+ t involves
 data collection f human subjects be=e !
 p]iod at ! end2  7,b7 by am5d+ clause  
7iii7 to read z foll[s3  7iii7          
,applicable drug cl9ical trial ,! t]m   
applicable drug cl9ical trial means an  
int]v5tional /udy ( a drug subject to   
section #eje ( ! ,f$]al ,food1 ,drug1 & 
,cosmetic ,act or to section #cea ( ?is 
,act1 includ+ any int]v5tional /udy ( a 
drug conduct$ outside ( ! ,unit$ ,/ates 
! results ( :i* are submitt$ to !       
,secret>y 9 support (--  7,i7 an ,,ind  
7z su* t]m is def9$ 9 section #cab4c (  
title #ba1 ,code ( ,f$]al ,regulations72

  7,,ii7 an application fil$ "u         
subsection 7b7 or 7j7 ( su* section #eje
 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic   
,act2 or  7,,iii7 an application = a    
lic5se "u section #cea4  2  7,c7 by     
r$esignat+ clauses 7iv7 ?r\gh 7ix7 z    
clauses 7v7 ?r\gh 7x71 respectively2    
7,d7 aft] clause 7iii71 by ins]t+ !     
foll[+ new clause3  7iv7 ,int]v5tional  
/udy ,= purposes ( clauses 7ii7 & 7iii71
 ! t]m int]v5tional /udy means a /udy 9 
human be+s 9 :i* individuals are assign$
 by an inve/igator1 bas$ on a protocol1 
to receive specific int]v5tions to      
evaluate _! effects on biom$ical or     
heal?-relat$ outcomes4  2 &  7,e7 9     
clause 7vi71 z r$esignat$ by subp>agraph
 7,c7--  7i7 9 ! head+1 by ins]t+ 2     
prim>y completion date aft] date2 &     
7ii7 by ins]t+ 1 also ref]r$ to z prim>y
 completion date1 be=e means2  7#b7 9   
p>agraph 7#b7--  7,a7 9 subp>agraph     
7,a77ii7--  7i7 by r$esignat+ subclauses
 7,,ii71 7,,iii71 & 7,,iv7 z subclauses 
7,,iii71 7,,iv71 & 7,v71 respectively2  

7ii7 by ins]t+ aft] subclause 7,i7 !    
foll[+3  7,,ii7 support+ docum5ts1      
includ+--  7aa7 cons5t docum5ts us$ to  
enroll subjects into ! trial1 z approv$ 
by ! ,in/itutional ,review ,bo>d or     
equival5t committee prior to ! />t ( !  
trial2 &  7bb7 protocol docum5ts1 z     
approv$ by ! ,in/itutional ,review ,bo>d
 or equival5t committee prior to ! />t (
 ! trial2  2 &  7iii7 9 subclause       
7,,iv71 z s r$esignat$1 9 item 7cc71 by 
ins]t+ 7or1 9 ! case ( a location       
outside ( ! ,unit$ ,/ates1 o!r          
appropriate location in=mation7 aft] zip
 code2  7,b7 9 subp>agraph 7,c77ii7 by  
/rik+ #ba days aft] & ins]t+ be=e2 &    
7,c7 by am5d+ subp>agraph 7,d7 to read z
 foll[s3  7,d7 ,po/+ ( ,data ,!         
,director ( ,,nih %all ensure t cl9ical 
trial in=mation = an applicable cl9ical 
trial submitt$ 9 accordance ) ?is       
p>agraph is po/$ publically 9 ! regi/ry 
data bank n lat] ?an #cj days aft] su*  
submission is det]m9$ to meet ! quality 
crit]ia e/abli%$ by ! ,director ( ,,nih4

  2  7#c7 9 p>agraph 7#c7--  7,a7 9     
subp>agraph 7,c7--  7i7 by /rik+ ,n lat]
 ?an #a ye> & all t foll[s ?r\gh ! colon
 & ins]t+ ,subject to subp>agraph       
7#b77;,c71 ! ,secret>y %all include 9 ! 
regi/ry & results data bank ! foll[+    
elem5ts = an applicable cl9ical trial32 
&  7ii7 by add+ at ! end ! foll[+ new   
clause3  7v7 ,support+ docum5ts ,f9al   
cons5t & protocol docum5ts1 includ+ all 
dat$ am5dm5ts to ! initial v]sion ( su* 
docum5ts1 z approv$ by ! ,in/itutional  
,review ,bo>d or equival5t committee4  2
  7,b7 9 subp>agraph 7,d7--  7i7 by     
/rik+ clauses 7ii7 & 7iv72  7ii7 9      
clause 7iii7--  7,i7 by /rik+ subclause 
7,,iii72 &  7,,ii7 by r$esignat+        
subclause 7,,iv7 z subclause 7,,iii72 & 
7iii7 by r$esignat+--  7,i7 clause 7iii7
 z clause 7ii72 &  7,,ii7 clauses 7v7   
?r\gh 7vii7 z clauses 7iii7 ?r\gh 7v71  
respectively2  7,c7 9 subp>agraph 7,e7--
  7i7 by /rik+ clauses 7i7 ?r\gh 7v7 &  
ins]t+ ! foll[+3  7i7 ,9 g5]al ,except z
 provid$ 9 clauses 7ii7 & 7iii71 !      

responsible p>ty = an applicable cl9ical
 trial %all submit to ! ,director (     
,,nih = inclusion 9 ! regi/ry & results 
data bank ! cl9ical trial in=mation     
describ$ 9 subp>agraph 7,c7 n lat] ?an  
#a ye> aft] ! prim>y completion date (  
su* trial4  7ii7 ,delay$ submission (   
results ) c]tification ,if ! responsible
 p>ty = an applicable cl9ical trial     
submits a c]tification t an applicable  
cl9ical trial involves a drug describ$ 9
 clause 7iii7 or a device describ$ 9    
clause 7iv71 ! responsible p>ty %all    
submit to ! ,director ( ,,nih1 =        
inclusion 9 ! regi/ry & results data    
bank1 ! cl9ical trial in=mation describ$
 9 subp>agraphs 7,c7 & 7,d7 n lat] ?an !
 e>lie/ ( ! foll[+3  7,i7 ,! lat] (--   
7aa7 #cj days aft] ! drug or device is  
approv$1 lic5s$1 or cle>$1 z applicable2
 or  7bb7 #a ye> aft] ! prim>y          
completion date ( ! applicable cl9ical  
trial4  7,,ii7 ,! date t is #b ye>s aft]
 ! prim>y completion date ( ! applicable
 cl9ical trial4  7iii7 ,drug describ$ ,a

 drug describ$ 9 ?is clause is a drug t 
conta9s an active +r$i5t1 includ+ any   
e/] or salt1 t has n be5 an +r$i5t 9 a  
drug approv$ 9 any o!r application "u   
section #eje ( ! ,f$]al ,food1 ,drug1 & 
,cosmetic ,act or lic5s$ = any use "u   
section #cea ( ?is ,act4  7iv7 ,device  
describ$ ,a device describ$ 9 ?is clause
 is a device t has n be5 approv$ or     
cle>$ = any use "u section #eaj7k7 or "u
 section #eae or #ebj7m7 ( ! ,f$]al     
,food1 ,drug1 & ,cosmetic ,act4  2  7ii7
 by r$esignat+ clause 7vi7 z clause 7v72
 &  7iii7 by add+ at ! end ! foll[+3    
7vi7 ,public po/+s relat$ to delays &   
ext5sions ,in=mation submitt$ by !      
responsible p>ty z "p ( a c]tification =
 delay$ submission ( results submitt$ "u
 clause 7ii7 or a reque/ = ext5sion     
submitt$ "u clause 7v7 %all be po/$     
publically 9 ! regi/ry data bank4  2    
7,d7 by /rik+ subp>agraph 7,f72  7,e7 by
 r$esignat+ subp>agraphs 7,g7 ?r\gh 7,i7
 z subp>agraphs 7,f7 ?r\gh 7,h71        
respectively2 &  7,f7 9 subp>agraph     

7,f71 z s r$esignat$1 by ins]t+ be=e !  
p]iod at ! end ! foll[+3 is det]m9$ to  
meet ! quality crit]ia e/abli%$ by !    
,director ( ,,nih2 &  7#d7 9 p>agraph   
7#d77;,b7--  7,a7 9 clause 7i77,,ii71 by
 /rik+ 7#c77;,e77iii7 & ins]t+          
7#c77;,e77ii72 &  7,b7 9 clause         
7ii77,,ii7--  7i7 by /rik+ by bo?2 &    
7ii7 by /rik+ & p>agraph                
7#c77;,d77ii77,,ii774  7b7              
,implem5tation ,! ,secret>y ( ,heal? &  
,human ,s]vices %all implem5t ! am5dm5ts
 made by subsection 7a7 n lat] ?an #f   
mon?s aft] ! date ( enactm5t ( ?is ,act4
  #c4 ,report+ requirem5t ,n lat] ?an #b
 ye>s aft] ! date ( ! enactm5t ( ?is    
,act1 & annually !reaft]1 ! ,director ( 
! ,national ,in/itutes ( ,heal? & !     
,commission] ( ! ,food & ,drug          
,adm9i/ration %all ea* submit to !      
,committee on ,en]gy & ,comm]ce ( !     
,h\se ( ,repres5tatives & ! ,committee  
on ,heal?1 ,education1 ,labor1 &        
,p5sions ( ! ,s5ate a report t includes 
! foll[+3  7#a7 ,bas$ on in=mation t is 

readily available 9 ! data bank describ$
 9 section #djb7;j7 ( ! ,public ,heal?  
,s]vice ,act 7#db ,u4,s4,c4 #bhb7;j77-- 
7,a7 ! numb] ( trials t ! ,director or  
,commission]1 z applicable1 has id5tifi$
 z trials t are likely to be subject to 
! report+ requirem5ts ( su* section2    
7,b7 ( ! trials id5tifi$ "u subp>agraph 
7,a71 ! e/imat$ numb]s & p]c5tages ( su*
 trials--  7i7 t h complete regi/ration 
in=mation2 &  7ii7 t h met ! result     
report+ requirem5ts ( section #djb7;j7 (
 ! ,public ,heal? ,s]vice ,act2 &  7,c7 
:e!r results ( ! trials h be5 submitt$  
by ! responsible p>ty by ! due dates    
outl9$ 9 section #djb7;j7 ( ! ,public   
,heal? ,s]vice ,act &1 if n1 :e!r       
c]tifications = delay$ submission ( su* 
results1 or reque/s = ext5sions1 h be5  
submitt$ by ! responsible p>ty4  ,=     
purposes ( ?is p>agraph1 ! ,secret>y may
 use an algori?m or o!r te*nique =      
effici5tly review+ l>ge am\nts ( data4  
7#b7 ,a description ( any actions tak5  
to consult ) o!r ,f$]al ag5cies "u      

#djb7;j77#e77;,a77iv7 ( ! ,public ,heal?
 ,s]vice ,act4  7#c7 ,9 ! case ( a      
report submitt$ by ! ,commission] ( !   
,food & ,drug ,adm9i/ration1 a          
description ( any en=cem5t actions tak5 
= violations ( section #cja7;jj7 ( !    
,f$]al ,food1 ,drug1 & ,cosmetic ,act   
7#ba ,u4,s4,c4 #cca7;jj771 includ+--    
7,a7 w>n+ lett]s or f9es impos$ relat$  
to report+ requirem5ts2 &  7,b7 any     
inquiries made to responsible p>ties to 
in=m ^? p>ties ( any pot5tial en=cem5t  
action4  7#d7 ,9 ! case ( a report      
submitt$ by ! ,director ( ! ,national   
,in/itutes ( ,heal?1 a description ( any
 actions tak5 to )hold grant funds f    
responsible p>ties t are n compliant ) !
 requirem5ts ( ?is section z indicat$ 9 
#djb7;j77#e77;,a7 ( ! ,public ,heal?    
,s]vice ,act4  #d4 ,rulemak+ relat$ to  
=eign cl9ical /udies  7a7 ,drugs ,n lat]
 ?an #a ye> aft] ! date ( enactm5t ( ?is
 ,act1 ! ,secret>y ( ,heal? & ,human    
,s]vices %all issue f9al regulations to 
am5d section #cab4abj ( title #ba1 ,code

 ( ,f$]al ,regulations 7relat+ to =eign 
cl9ical /udies n conduct$ "u an ,,ind7  
to require t cl9ical trial in=mation =  
su* a =eign cl9ical /udy be submitt$ =  
inclusion 9 ! regi/ry & results data    
bank 9 accordance ) section #djb7;j7 ( !
 ,public ,heal? ,s]vice ,act 7#db       
,u4,s4,c4 #bhb7;j771 z am5d$ by ?is     
,act1 z a condition = ! acceptance ( su*
 /udy z support = an ,,ind 7z su* t]m is
 def9$ 9 section #cab4c ( title #ba1    
,code ( ,f$]al ,regulations7 or         
application = m>ket+ approval 7an       
application "u section #eje ( ! ,f$]al  
,food1 ,drug1 & ,cosmetic ,act 7#ba     
,u4,s4,c4 #cee7 or section #cea ( !     
,public ,heal? ,s]vice ,act 7#db        
,u4,s4,c4 #bfb774  7b7 ,devices ,n lat] 
?an #a ye> aft] ! date ( enactm5t ( ?is 
,act1 ! ,secret>y ( ,heal? & ,human     
,s]vices %all issue f9al regulations    
7includ+ regulations am5d+ section      
#had4ae ( title #ba1 ,code ( ,f$]al     
,regulations 7relat+ to rese>* conduct$ 
outside ! ,unit$ ,/ates77 to require t  

cl9ical trial in=mation = /udies        
conduct$ outside ! ,unit$ ,/ates be     
submitt$ = inclusion 9 ! regi/ry &      
results data bank 9 accordance ) section
 #djb7;j7 ( ! ,public ,heal? ,s]vice    
,act 7#db ,u4,s4,c4 #bhb7;j771 z am5d$  
by ?is ,act1 z a condition = !          
acceptance ( su* /udies to support a    
,,pma 7z su* t]m is def9$ 9 section     
#had4c7;e7 ( title #ba1 ,code ( ,f$]al  
,regulations71 a prem>ket notification  
requir$ "u section #eaj7k7 ( ! ,f$]al   
,food1 ,drug1 & ,cosmetic ,act 7#ba     
,u4,s4,c4 #cfj7k771 or ,,hde 7z su* t]m 
is def9$ 9 section #had4c7m7 ( title    
#ba1 ,code ( ,f$]al ,regulations74