,,ii  #aad? ,,congress  #a/ ,session    
,s4 #dha  ,,9 ,,! ,,s5ate ,,( ,,!       
,,unit$ ,,/ates  ,febru>y #ab1 #bjae,mr4
 ,hat* 7= himself & ,mr4 ,:iteh\se7     
introduc$ ! foll[+ bill2 :i* 0 read     
twice & ref]r$ to ! ,committee on       
,heal?1 ,education1 ,labor1 & ,p5sions  
,a ,,bill  ,to am5d ! ,controll$        
,sub/ances ,act & ! ,f$]al ,food1 ,drug1
 & ,cosmetic ,act ) respect to drug     
s*$ul+ recomm5dations by ! ,secret>y (  
,heal? & ,human ,s]vices1 & ) respect to
 regi/ration ( manufactur]s &           
di/ributors seek+ to conduct cl9ical    
te/+1 & = o!r purposes4  #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  7a7  
,effective date ( approval  7#a7        
,effective date ( drug approval ,section
 #eje ( ! ,f$]al ,food1 ,drug1 &        
,cosmetic ,act 7#ba ,u4,s4,c4 #cee7 is  
am5d$ by add+ at ! end ! foll[+3  7x7   
,date ( approval 9 ! case ( recomm5d$   

controls "u ! ,,csa  7#a7 ,9 g5]al ,9 ! 
case ( an application "u subsection 7b7 
) respect to a drug = :i* ! ,secret>y   
provides notice to ! sponsor t !        
,secret>y int5ds to recomm5d controls "u
 ! ,controll$ ,sub/ances ,act1 approval 
( su* application %all n take effect    
until ! int]im f9al rule controll+ !    
drug is issu$ 9 accordance ) section    
#bja7;j7 ( ! ,controll$ ,sub/ances ,act4
  7#b7 ,date ( approval ,= purposes (   
?is section1 ) respect to an application
 describ$ 9 p>agraph 7#a71 ! t]m date ( 
approval %all mean ! lat] (-- 7,a7 !    
date an application "u subsection 7b7 is
 approv$ "u subsection 7c72 or  7,b7 !  
date ( issuance ( ! int]im f9al rule    
controll+ ! drug4  4  7#b7 ,effective   
date ( approval ( biological products   
,section #cea ( ! ,public ,heal? ,s]vice
 ,act 7#db ,u4,s4,c4 #bfb7 is am5d$ by  
add+ at ! end ! foll[+3  7n7 ,date (    
approval 9 ! case ( recomm5d$ controls  
"u ! ,,csa  7#a7 ,9 g5]al ,9 ! case ( an
 application "u subsection 7a7 ) respect

 to a biological product = :i* !        
,secret>y provides notice to ! sponsor t
 ! ,secret>y int5ds to recomm5d controls
 "u ! ,controll$ ,sub/ances ,act1       
approval ( su* application %all n take  
effect until ! int]im f9al rule         
controll+ ! biological product is issu$ 
9 accordance ) section #bja7;j7 ( !     
,controll$ ,sub/ances ,act4  7#b7 ,date 
( approval ,= purposes ( ?is section1 ) 
respect to an application describ$ 9    
p>agraph 7#a71 ref]5ces to ! date (     
approval ( su* application1 or lic5sure 
( ! product subject to su* application1 
%all mean ! lat] (--  7,a7 ! date an    
application is approv$ "u subsection    
7a72 or  7,b7 ! date ( issuance ( !     
int]im f9al rule controll+ ! biological 
product4  4  7#c7 ,effective date (     
approval ( animal drugs  7,a7 ,9 g5]al  
,section #eab ( ! ,f$]al ,food1 ,drug1 &
 ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;b7  
is am5d$ by add+ at ! end ! foll[+3  7q7
 ,date ( approval 9 ! case ( recomm5d$  
controls "u ! ,,csa  7#a7 ,9 g5]al ,9 ! 

case ( an application "u subsection 7b7 
) respect to a drug = :i* ! ,secret>y   
provides notice to ! sponsor t !        
,secret>y int5ds to recomm5d controls "u
 ! ,controll$ ,sub/ances ,act1 approval 
( su* application %all n take effect    
until ! int]im f9al rule controll+ !    
drug is issu$ 9 accordance ) section    
#bja7;j7 ( ! ,controll$ ,sub/ances ,act4
  7#b7 ,date ( approval ,= purposes (   
?is section1 ) respect to an application
 describ$ 9 p>agraph 7#a71 ! t]m date ( 
approval %all mean ! lat] (-- 7,a7 !    
date an application "u subsection 7b7 is
 approv$ "u subsection 7c72 or  7,b7 !  
date ( issuance ( ! int]im f9al rule    
controll+ ! drug4  4  7,b7 ,conditional 
approval ,section #ega7;d7 ( ! ,f$]al   
,food1 ,drug1 & ,cosmetic ,act 7#ba     
,u4,s4,c4 #cfj;ccc7d77 is am5d$ by add+ 
at ! end ! foll[+3  7#d7 7,a7 ,9 ! case 
( an application "u subsection 7a7 )    
respect to a drug = :i* ! ,secret>y     
provides notice to ! sponsor t !        
,secret>y int5ds to recomm5d controls "u

 ! ,controll$ ,sub/ances ,act1          
conditional approval ( su* application  
%all n take effect until ! int]im f9al  
rule controll+ ! drug is issu$ 9        
accordance ) section #bja7;j7 ( !       
,controll$ ,sub/ances ,act4  7,b7 ,=    
purposes ( ?is section1 ) respect to an 
application describ$ 9 subp>agraph 7,a71
 ! t]m date ( approval %all mean ! lat] 
(--  7i7 ! date an application "u       
subsection 7a7 is conditionally approv$ 
"u subsection 7b72 or  7ii7 ! date (    
issuance ( ! int]im f9al rule controll+ 
! drug4  4  7,c7 ,index+ ( legally      
m>ket$ unapprov$ new animal drugs       
,section #egb ( ! ,f$]al ,food1 ,drug1 &
 ,cosmetic ,act 7#ba ,u4,s4,c4          
#cfj;ccc-#a7 is am5d$ by add+ at ! end !
 foll[+3  7k7 ,9 ! case ( a reque/ "u   
subsection 7d7 to add a drug to ! index 
"u subsection 7a7 ) respect to a drug = 
:i* ! ,secret>y provides notice to !    
p]son fil+ ! reque/ t ! ,secret>y int5ds
 to recomm5d controls "u ! ,controll$   
,sub/ances ,act1 a det]m9ation to grant 

! reque/ to add su* drug to ! index %all
 n take effect1 & ! ,secret>y %all n li/
 ! drug on su* index1 until ! int]im    
f9al rule controll+ ! drug is issu$ 9   
accordance ) section #bja7;j7 ( !       
,controll$ ,sub/ances ,act4  4  7#d7    
,date ( approval = designat$ new animal 
drugs ,section #egc7;c7 ( ! ,f$]al      
,food1 ,drug1 & ,cosmetic ,act 7#ba     
,u4,s4,c4 #cfj;ccc-#b7;c77 is am5d$ by  
add+ at ! end ! foll[+3  7#c7 ,=        
purposes ( det]m9+ ! #g-ye> p]iod (     
exclusivity "u p>agraph 7#a7 = a drug = 
:i* ! ,secret>y int5ds to recomm5d      
controls "u ! ,controll$ ,sub/ances     
,act1 ! drug %all n be consid]$ approv$ 
or conditionally approv$ until ! date t 
! int]im f9al rule controll+ ! drug is  
issu$ 9 accordance ) section #bja7;j7 ( 
! ,controll$ ,sub/ances ,act4  4  7b7   
,s*$ul+ ( newly approv$ drugs ,section  
#bja ( ! ,controll$ ,sub/ances ,act 7#ba
 ,u4,s4,c4 #haa7 is am5d$ by ins]t+ aft]
 subsection 7i7 ! foll[+3  7j7  7#a7 ,) 
respect to a drug ref]r$ to 9 subsection

 7f71 if ! ,secret>y ( ,heal? & ,human  
,s]vices recomm5ds t ! ,attorney ,g5]al 
add ! drug to s*$ule ,,ii1 ,,iii1 ,,iv1 
or ,v pursuant to subsections 7a7 & 7b71
 ! ,attorney ,g5]al %all1 n lat] ?an #ij
 days aft] ! date describ$ 9 p>agraph   
7#b71 issue an int]im f9al rule         
controll+ ! drug 9 accordance ) su*     
subsections & section #bjb7;b7 us+ !    
proc$ures describ$ 9 p>agraph 7#c74     
7#b7 ,! date describ$ 9 ?is p>agraph    
%all be ! lat] (-- 7,a7 ! date on :i* ! 
,attorney ,g5]al receives ! sci5tific & 
m$ical evaluation & recomm5dations f !  
,secret>y ( ,heal? & ,human ,s]vices 9  
accordance ) subsection 7b72 or  7,b7 ! 
date on :i* ! ,attorney ,g5]al receives 
notification f ! ,secret>y ( ,heal? &   
,human ,s]vices t ! ,secret>y has       
approv$ an application "u section       
#eje7;c71 #eab1 #ega1 or #egb ( ! ,f$]al
 ,food1 ,drug1 & ,cosmetic ,act or      
section #cea7;a7 ( ! ,public ,heal?     
,s]vice ,act ) respect to ! drug        
describ$ 9 p>agraph 7#a74  7#c7 ,a rule 

issu$ by ! ,attorney ,g5]al "u p>agraph 
7#a7 %all be 9 accordance ) ! proc$ures 
provid$ 9 subsection 7a71 except t !    
rule %all become imm$iately effective z 
an int]im f9al rule )\t requir+ !       
,attorney ,g5]al to demon/rate good     
cause !re=4 ,aft] publication ( ! int]im
 f9al rule1 ! ,attorney ,g5]al %all     
issue a f9al rule 9 accordance ) !      
proc$ures provid$ 9 subsection 7a74  4  
7c7 ,ext5sion ( pat5t t]m ,section #aef 
( title #ce1 ,unit$ ,/ates ,code1 is    
am5d$-- 7#a7 9 subsection 7d77#a71 9 !  
matt] prec$+ subp>agraph 7,a71 by ins]t+
 1 or 9 ! case ( a drug product describ$
 9 subsection 7i7 )9 ! sixty-day p]iod  
beg9n+ on ! cov]$ date 7z def9$ 9       
subsection 7i77 aft] m>ket+ or use2 &   
7#b7 by add+ at ! end ! foll[+3  7i7    
7#a7 ,= purposes ( ?is section1 if !    
,secret>y ( ,heal? & ,human ,s]vices    
provides notice to ! sponsor ( an       
application or reque/ = approval1       
conditional approval1 or index+ ( a drug
 product = :i* ! ,secret>y int5ds to    

recomm5d controls "u ! ,controll$       
,sub/ances ,act1 beg9n+ on ! cov]$ date1
 ! drug product %all be consid]$ to--   
7,a7 h be5 approv$2 &  7,b7 h p]mission 
= comm]cial m>ket+ or use4  7#b7 ,9 ?is 
subsection1 ! t]m cov]$ date means !    
lat] (-- 7,a7 ! date an application is  
approv$--  7i7 "u section               
#cea7;a77#b77;,c7 ( ! ,public ,heal?    
,s]vice ,act2 or  7ii7 "u section       
#eje7;b7 or #eab7;c7 ( ! ,f$]al ,food1  
,drug1 & ,cosmetic ,act2  7,b7 ! date an
 application is conditionally approv$ "u
 section #ega7;b7 ( ! ,f$]al ,food1     
,drug1 & ,cosmetic ,act2  7,c7 ! date a 
reque/ = index+ is grant$ "u section    
#egb7;d7 ( ! ,f$]al ,food1 ,drug1 &     
,cosmetic ,act2 or  7,d7 ! date (       
issuance ( ! int]im f9al rule controll+ 
! drug "u section #bja7;j7 ( !          
,controll$ ,sub/ances ,act4  4  #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 = use only 9 
a cl9ical trial1 ! ,attorney ,g5]al %all
 regi/] ! applicant1 or s]ve an ord] to 
%[ cause ^u ! applicant 9 accordance )  
section #cjd7;c71 n lat] ?an #ahj days  
aft] ! date on :i* ! application is     
accept$ = fil+4  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] ! 
application is accept$ = fil+4 ,n lat]  
?an #ij days aft] ! date on :i* ! p]iod 
= comm5t pursuant to su* notice ends1 ! 
,attorney ,g5]al %all regi/] !          
applicant1 or s]ve an ord] to %[ cause  
^u ! applicant 9 accordance ) section   
#cjd7;c71 unless ! ,attorney ,g5]al has 
grant$ a he>+ on ! application "u       
section #ajjh7;i7 ( ! ,controll$        
,sub/ances ,import & ,export ,act4  4