,,ib  ,union ,cal5d> ,no4 #dea  #aac?   
,,congress  #b;d ,session  ,h4 ,r4 #dbii
  ,report ,no4 #aac-efe1 ,p>ts ,i & ,,ii
  ,,9 ,,! ,,h\se ,,( ,,repres5tatives   
,m>* #bf1 #bjad ,mr4 ,pitts 7= himself &
 ,mr4 ,pallone7 introduc$ ! foll[+ bill2
 :i* 0 ref]r$ to ! ,committee on ,en]gy 
& ,comm]ce1 & 9 addition to ! ,committee
 on ! ,judici>y1 = a p]iod to be        
subsequ5tly det]m9$ by ! ,speak]1 9 ea* 
case = consid]ation ( su* provisions z  
fall )9 ! jurisdiction ( ! committee    
conc]n$  ,july #bi1 #bjad ,report$ f !  
,committee on ,en]gy & ,comm]ce  ,july  
#bi1 #bjad ,ref]ral to ! ,committee on !
 ,judici>y ext5d$ = a p]iod end+ n lat] 
?an ,septemb] #ai1 #bjad  ,septemb] #ai1
 #bjad ,additional sponsors3 ,mr4       
,burgess1 ,mrs4 ,mc,morris ,rodg]s1     
,mrs4 ,blackburn1 ,mr4 ,g+rey (         
,georgia1 ,mr4 ,griffi? ( ,virg9ia1 ,mr4
 ,g5e ,gre5 ( ,texas1 ,mr4 ,latta1 ,mr4 
,engel1 ,ms4 ,%ea-,port]1 ,mr4          
,butt]field1 ,mr4 ,tonko1 ,mr4 ,johnson 
( ,ohio1 ,mr4 ,h>p]1 & ,mr4 ,coll9s (   

,georgia  ,septemb] #ai1 #bjad ,report$ 
f ! ,committee on ! ,judici>y ) an      
am5dm5t ,/rike out all aft] ! enact+    
clause & ins]t ! "p pr9t$ 9 italic ,=   
text ( introduc$ bill1 see copy ( bill z
 introduc$ on ,m>* #bf1 #bjad  ,a ,,bill
  ,to am5d ! ,controll$ ,sub/ances ,act 
) respect to drug s*$ul+ recomm5dations 
by ! ,secret>y ( ,heal? & ,human        
,s]vices1 & ) respect to regi/ration (  
manufactur]s & di/ributors seek+ to     
conduct cl9ical te/+4  #a4 ,%ort title  
,?is ,act may be cit$ z ! ,improv+      
,regulatory ,transp>5cy = ,new ,m$ical  
,!rapies ,act4  #b4 ,s*$ul+ ( sub/ances 
includ$ 9 new ,,fda-approv$ drugs       
,section #bja7;a7 ( ! ,controll$        
,sub/ances ,act 7#ba ,u4,s4,c4 #haa7;a77
 is am5d$ by add+ at ! end ! foll[+3    
,any su* proce$+s initiat$ at ! reque/ (
 ! ,secret>y "u ?is subsection to       
control a drug or o!r sub/ance n        
previ\sly s*$ul$1 :]e ! ,secret>y has   
recomm5d$ ! drug or o!r sub/ance be     
plac$ 9 s*$ule ,,ii1 ,,iii1 ,,iv1 or ,v1

 %all be comm5c$ n lat] ?an #abj days   
aft] receipt ( writt5 recomm5dations f !
 ,secret>y4 ,! f9al rule %all be issu$ n
 lat] ?an #fj days aft] ! date on :i*   
bo? ! public comm5t p]iod has clos$ & ! 
drug or o!r sub/ance is ! subject ( an  
approv$ new drug application "u section 
#eje ( ! ,f$]al ,food1 ,drug1 &         
,cosmetic ,act1 unless a he>+ on !      
propos$ rule is grant$ by ! ,attorney   
,g5]al44  #c4 ,enhanc+ new drug         
developm5t ,section #cjc ( ! ,controll$ 
,sub/ances ,act 7#ba ,u4,s4,c4 #hbc7 is 
am5d$ by add+ at ! end ! foll[+3  7i7   
7#a7 ,= ! purposes ( regi/ration to     
manufacture a controll$ sub/ance "u     
subsection 7d7 ( ?is section = use only 
9 a cl9ical trial1 ! ,attorney ,g5]al   
%all regi/] an applicant or s]ve an ord]
 to %[ cause ^u an applicant pursuant to
 section #cjd7;c7 ( ?is ,act n lat] ?an 
#ahj days aft] receipt ( an application 
& all in=mation ! ,attorney ,g5]al deems
 necess>y to make a det]m9ation "u      
subsection 7d74  7#b7 ,= ! purposes (   

regi/ration to manufacture a controll$  
sub/ance "u subsection 7a7 = use only 9 
a cl9ical trial1 ! ,attorney ,g5]al     
%all1 9 accordance ) regulations issu$  
by ! ,attorney ,g5]al1 issue a notice ( 
application n lat] ?an #ij days aft]    
receipt ( an application & all in=mation
 ! ,attorney ,g5]al deems necess>y to   
issue a notice ( application4 ,foll[+ ! 
close ( ! comm5t p]iod & receipt ( all  
in=mation ! ,attorney ,g5]al deems      
necess>y to make a det]m9ation "u       
subsection 7a71 ! ,attorney ,g5]al %all 
regi/] an applicant or s]ve an ord] to  
%[ cause ^u an applicant pursuant to    
section #cjd7;c7 ( ?is ,act )9 #ahj     
days1 unless a he>+ on ! application has
 be5 grant$ by ! ,attorney ,g5]al       
pursuant to section #ajjh7;i7 ( !       
,controll$ ,sub/ances ,import & ,export 
,act4  4  ,septemb] #ai1 #bjad ,report$ 
f ! ,committee on ! ,judici>y ) an      
am5dm5t