,,ii ,cal5d> ,no4 #bde #aad? ,,congress 
#a/ ,session  ,s4 #dha  ,,9 ,,! ,,s5ate 
,,( ,,! ,,unit$ ,,/ates  ,febru>y #ab1  
#bjae,mr4 ,hat* 7= himself1 ,mr4        
,:iteh\se1 & ,mrs4 ,murray7 introduc$ ! 
foll[+ bill2 :i* 0 read twice & ref]r$  
to ! ,committee on ,heal?1 ,education1  
,labor1 & ,p5sions  ,octob] #a1         
#bjae,report$ by ,mr4 ,alex&]1 ) an     
amendment,strike out all aft] ! enact+  
clause & ins]t ! "p pr9t$ 9 italic  ,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   
#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 issue a sci5tific & 
m$ical evaluation & recomm5d controls "u
 ! ,controll$ ,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 issue a sci5tific
 & m$ical evaluation & recomm5d controls
 "u ! ,controll$ ,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 issue a sci5tific & 
m$ical evaluation & recomm5d controls "u
 ! ,controll$ ,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 issue a sci5tific & 
m$ical evaluation & recomm5d controls "u
 ! ,controll$ ,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 issue a sci5tific & m$ical          
evaluation & recomm5d controls "u !     
,controll$ ,sub/ances ,act1 a           
det]m9ation to grant ! reque/ to add su*
 drug to ! index %all n take effect     
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 issue a       
sci5tific & m$ical evaluation & recomm5d
 controls "u ! ,controll$ ,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 
control ! drug 9 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$ical evaluation & ! s*$ul+            
recomm5dation 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  
or #ega ( ! ,f$]al ,food1 ,drug1 &      
,cosmetic ,act or section #cea7;a7 ( !  
,public ,heal? ,s]vice ,act1 or index$ a
 drug "u section #egb ( ! ,f$]al ,food1 
,drug1 & ,cosmetic ,act1 ) respect to ! 
drug describ$ 9 p>agraph 7#a74  7#c7 ,a 
rule issu$ by ! ,attorney ,g5]al "u     
p>agraph 7#a7 %all become imm$iately    
effective z an int]im f9al rule )\t     
requir+ ! ,attorney ,g5]al to demon/rate
 good cause !re=4 ,! int]im f9al rule   

%all give int]e/$ p]sons ! opportunity  
to comm5t & to reque/ a he>+4 ,aft] !   
conclusion ( su* proce$+s1 ! ,attorney  
,g5]al %all issue a f9al rule 9         
accordance ) ! s*$ul+ crit]ia (         
subsections 7b71 7c71 & 7d7 ( ?is       
section & section #bjb7;b74  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 7i71 )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$ or index$ "u !       
relevant provision ( ! ,public ,heal?   
,s]vice ,act or ,f$]al ,food1 ,drug1 &  
,cosmetic ,act2 &  7,b7 h p]mission =   
comm]cial m>ket+ or use4  7#b7 ,9 ?is   
subsection1 ! t]m cov]$ 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   
#d4 ,re-,exportation ,among ,memb]s ( ! 

,european ,economic ,area ,section #ajjc
 ( ! ,controll$ ,sub/ances ,import &    
,export ,act 7#ba ,u4,s4,c4 #iec7 is    
am5d$-- 7#a7 9 subsection7f7--  7,a7 9  
p>agraph 7#e7-- 7i7 by /rik+ 7#e7 &     
ins]t+ 7#e77;,a72  7ii7 by ins]t+ 1     
except t ! controll$ sub/ance may be    
export$ f a second c\ntry t is a memb] (
 ! ,european ,economic ,area to ano!r   
c\ntry t is a memb] ( ! ,european       
,economic ,area1 provid$ t ! fir/ c\ntry
 is also a memb] ( ! ,european ,economic
 ,area be=e ! p]iod at ! end2 &  7iii7  
by add+ at ! end ! foll[+3  7,b7        
,subsequ5t to any re-exportation        
describ$ 9 subp>agraph 7,a71 a controll$
 sub/ance may cont9ue to be export$ f   
any c\ntry t is a memb] ( ! ,european   
,economic ,area to any o!r su* c\ntry1  
if--  7i7 ! conditions applicable )     
respect to ! fir/ c\ntry "u p>agraphs   
7#a71 7#b71 7#c71 7#d71 7#f71 & 7#g7 are
 met by ea* subsequ5t c\ntry f :i* !    
controll$ sub/ance is export$ pursuant  
to ?is p>agraph2 &  7ii7 ! conditions   

applicable ) respect to ! second c\ntry 
"u p>agraphs 7#a71 7#b71 7#c71 7#d71    
7#f71 & 7#g7 are met by ea* subsequ5t   
c\ntry to :i* ! controll$ sub/ance is   
export$ pursuant to ?is p>agraph4  2 &  
7,b7 9 p>agraph 7#f7-- 7i7 by /rik+ 7#f7
 & ins]t+ 7#f77;,a72 &  7ii7 by add+ at 
! end ! foll[+3  7,b7 ,9 ! case (       
re-exportation among memb]s ( !         
,european ,economic ,area1 )9 #cj days  
aft] ea* re-exportation1 ! p]son :o     
export$ ! controll$ sub/ance f ! ,unit$ 
,/ates deliv]s to ! ,attorney ,g5]al--  
7i7 docum5tation c]tify+ t su*          
re-exportation has occurr$2 &  7ii7     
in=mation conc]n+ ! consignee1 c\ntry1 &
 product4  2 &  7#b7 by add+ at ! end ! 
foll[+3  7g7 ,limitation ,subject to    
p>agraphs 7#e7 & 7#f7 ( subsection 7f7 9
 ! case ( any controll$ sub/ance 9      
s*$ule ,i or ,,ii or any n>cotic drug 9 
s*$ule ,,iii or ,,iv1 ! ,attorney ,g5]al
 %all n promulgate nor en=ce any        
regulation1 subregulatory guidance1 or  
en=cem5t policy :i* imp$es              

re-exportation ( any controll$ sub/ance 
among ,european ,economic ,area         
c\ntries1 includ+ by promulgat+ or en=c+
 any requirem5t t--  7#a7 re-exportation
 f ! fir/ c\ntry to ! second c\ntry or  
re-exportation f ! second c\ntry to     
ano!r c\ntry occur )9 a specifi$ p]iod (
 "t2 or  7#b7 in=mation conc]n+ !       
consignee1 c\ntry1 & product be provid$ 
prior to exportation ( ! controll$      
sub/ance f ! ,unit$ ,/ates or prior to  
ea* re-exportation among memb]s ( !     
,european ,economic ,area4  4  ,octob]  
#a1 #bjae,report$ ) an am5dm5t