,i  #aac? ,,congress  #b;d ,session  ,h4
 ,r4 #dbii  ,,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$  ,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 #bja ( ! ,controll$ ,sub/ances 
,act 7#ba ,u4,s4,c4 #haa7 is am5d$ by   
ins]t+ aft] subsection 7h7 ! foll[+3    
7i7 ,)9 #de days ( receiv+ a            

recomm5dation f ! ,secret>y to add a    
drug or sub/ance t has nev] be5 m>ket$ 9
 ! ,unit$ ,/ates to a s*$ule "u ?is     
title1 ! ,attorney ,g5]al %all1 )\t     
reg>d to ! f9d+s requir$ by subsection  
7a7 ( ?is section or section #bjb7;b71  
issue an int]im f9al rule1 "u !         
exception = good cause describ$ 9       
subp>agraph 7,b7 ( section #eec7;b7 (   
title #e1 ,unit$ ,/ates ,code1 plac+ !  
drug or sub/ance into ! s*$ule recomm5d$
 by ! ,secret>y4 ,! int]im f9al rule    
%all be made imm$iately effective "u    
section #eec7;d77#c7 ( title #e1 ,unit$ 
,/ates ,code4  4  #c4 ,enhanc+ new drug 
developm5t ,section #cjb ( ! ,controll$ 
,sub/ances ,act 7#ba ,u4,s4,c4 #hbb7 is 
am5d$ by ins]t+ aft] subsection 7g7 !   
foll[+3  7h7  7#a7 ,a p]son :o submits  
an application = regi/ration to         
manufacture or di/ribute a controll$    
sub/ance 9 accordance ) ?is section may 
indicate on ! regi/ration application t 
! sub/ance w be us$ only 9 connection ) 
cl9ical trials ( a drug 9 accordance )  

section #eje7;i7 ( ! ,f$]al ,food1      
,drug1 & ,cosmetic ,act4  7#b7 ,:5 an   
application = regi/ration to manufacture
 or di/ribute a controll$ sub/ance      
includes an indication t ! controll$    
sub/ance w be us$ only 9 connection )   
cl9ical trials ( a drug 9 accordance )  
section #eje7;i7 ( ! ,f$]al ,food1      
,drug1 & ,cosmetic ,act1 ! ,attorney    
,g5]al %all--  7,a7 make a f9al decision
 on ! application = regi/ration )9 #ahj 
days2 or  7,b7 provide notice to !      
applicant 9 writ+ (--  7i7 ! out/&+     
issues t mu/ be resolv$ 9 ord] to rea* a
 f9al decision on ! application2 &  7ii7
 ! e/imat$ date on :i* a f9al decision  
on ! application w be made4  4