,,ii ,cal5d> ,no4 #ah #aai? ,,congress  
#a/ ,session  ,s4 #cca  ,,9 ,,! ,,s5ate 
,,( ,,! ,,unit$ ,,/ates  ,janu>y #cj1   
#bjbe,mr4 ,cassidy 7= himself1 ,mr4     
,he9ri*1 ,mr4 ,grassley1 ,mr4 ,m>%all1  
,mr4 ,"y1 ,mr4 ,da9es1 ,mr4 ,r\nds1     
,mrs4 ,capito1 ,mr4 ,s*mitt1 ,mr4       
,k5n$y1 ,mr4 ,gallego1 ,ms4 ,hassan1    
,ms4 ,cortez ,ma/o1 ,mrs4 ,%ahe51 ,mr4  
,k+1 ,mr4 ,kelly1 ,mr4 ,cornyn1 ,mr4    
,hawley1 ,mr4 ,tillis1 ,mr4 ,graham1    
,mr4 ,cruz1 ,mrs4 ,britt1 ,mrs4         
,blackburn1 ,mr4 ,lee1 & ,mrs4 ,moody7  
introduc$ ! foll[+ bill2 :i* 0 read     
twice & ref]r$ to ! ,committee on !     
,judici>y  ,m>* #c1 #bjbe,report$ by    
,mr4 ,grassley1 ) an amendment,strike   
out all aft] ! enact+ clause & ins]t !  
"p pr9t$ 9 italic  ,a ,,bill  ,to am5d !
 ,controll$ ,sub/ances ,act ) respect to
 ! s*$ul+ ( f5tanyl-relat$ sub/ances1 & 
= o!r purposes4  #a4 ,%ort title ,?is   
,act may be cit$ z ! ,halt ,all ,le?al  
,traffick+ ( ,f5tanyl ,act or ! ,,halt  
,f5tanyl ,act4  #b4 ,class s*$ul+ (     

f5tanyl-relat$ sub/ances ,section       
#bjb7;c7 ( ! ,controll$ ,sub/ances ,act 
7#ba ,u4,s4,c4 #hab7;c77 is am5d$ by    
add+ at ! end ( s*$ule ,i ! foll[+3  7e7
 7#a7 ,unless specifically exempt$ or   
unless li/$ 9 ano!r s*$ule1 any mat]ial1
 comp\nd1 mixture1 or prep>ation :i*    
conta9s any quantity ( a f5tanyl-relat$ 
sub/ance1 or :i* conta9s ! salts1       
isom]s1 & salts ( isom]s ( a            
f5tanyl-relat$ sub/ance :5ev] ! exi/5ce 
( su* salts1 isom]s1 & salts ( isom]s is
 possible )9 ! specific *emical         
designation4  7#b7 ,= purposes (        
p>agraph 7#a71 except z provid$ 9       
p>agraph 7#c71 ! t]m f5tanyl-relat$     
sub/ance means any sub/ance t is        
/ructurally relat$ to f5tanyl by #a or m
 ( ! foll[+ modifications3 7,a7 ,by     
replacem5t ( ! ph5yl portion ( ! ph5e?yl
 gr\p by any monocycle1 :e!r or n fur!r 
sub/itut$ 9 or on ! monocycle4  7,b7 ,by
 sub/itution 9 or on ! ph5e?yl gr\p )   
alkyl1 alk5yl1 alkoxyl1 hydroxyl1 halo1 
haloalkyl1 am9o1 or nitro gr\ps4  7,c7  

,by sub/itution 9 or on ! pip]id9e r+ ) 
alkyl1 alk5yl1 alkoxyl1 e/]1 e!r1       
hydroxyl1 halo1 haloalkyl1 am9o1 or     
nitro gr\ps4  7,d7 ,by replacem5t ( !   
anil9e r+ ) any aromatic monocycle :e!r 
or n fur!r sub/itut$ 9 or on ! aromatic 
monocycle4  7,e7 ,by replacem5t ( !     
,n-propionyl gr\p ) ano!r acyl gr\p4    
7#c7 ,a sub/ance t satisfies ! def9ition
 ( ! t]m f5tanyl-relat$ sub/ance 9      
p>agraph 7#b7 %all none!less n be treat$
 z a f5tanyl-relat$ sub/ance subject to 
?is s*$ule if ! sub/ance-- 7,a7 is      
controll$ by action ( ! ,attorney ,g5]al
 "u section #bja2 or  7,b7 is o!rwise   
expressly li/$ 9 a s*$ule o!r ?an ?is   
s*$ule4  7#d7 7,a7 ,! ,attorney ,g5]al  
may by ord] publi% 9 ! ,f$]al ,regi/] a 
li/ ( sub/ances t satisfy ! def9ition ( 
! t]m f5tanyl-relat$ sub/ance 9 p>agraph
 7#b74  7,b7 ,! abs5ce ( a sub/ance f a 
li/ publi%$ "u subp>agraph 7,a7 does n  
negate ! control /atus ( ! sub/ance "u  
?is s*$ule if ! sub/ance satisfies !    
def9ition ( ! t]m f5tanyl-relat$        

sub/ance 9 p>agraph 7#b74  4  #c4       
,regi/ration requirem5ts relat$ to      
rese>*  7a7 ,alt]native regi/ration     
process = s*$ule ,i rese>* ,section #cjc
 ( ! ,controll$ ,sub/ances ,act 7#ba    
,u4,s4,c4 #hbc7 is am5d$-- 7#a7 by      
r$esignat+ ! second subsection 7l7      
7relat+ to requir$ tra9+ = prescrib]s7 z
 subsection 7m72 &  7#b7 by add+ at !   
end ! foll[+3  7n7 ,special provisions =
 practition]s conduct+ c]ta9 rese>* )   
s*$ule ,i controll$ sub/ances  7#a7 ,9  
g5]al ,not)/&+ subsection 7g71 a        
practition] may conduct rese>* describ$ 
9 p>agraph 7#b7 ( ?is subsection ) #a or
 m s*$ule ,i sub/ances 9 accordance )   
subp>agraph 7,a7 or 7,b7 ( p>agraph 7#c7
 ( ?is subsection4  7#b7 ,rese>* subject
 to exp$it$ proc$ures ,rese>* describ$ 9
 ?is p>agraph is rese>* t-- 7,a7 is )   
respect to a drug t is ! subject ( an   
inve/igational use exemption "u section 
#eje7;i7 ( ! ,f$]al ,food1 ,drug1 &     
,cosmetic ,act 7#ba ,u4,s4,c4 #cee7;i772
 or  7,b7 is-- 7i7 conduct$ by !        

,dep>tm5t ( ,heal? & ,human ,s]vices1 ! 
,dep>tm5t ( ,def5se1 or ! ,dep>tm5t (   
,vet]ans ,affairs2 or  7ii7 fund$ p>tly 
or entirely by a grant1 contract1       
coop]ative agreem5t1 or o!r transaction 
f ! ,dep>tm5t ( ,heal? & ,human         
,s]vices1 ! ,dep>tm5t ( ,def5se1 or !   
,dep>tm5t ( ,vet]ans ,affairs4  7#c7    
,exp$it$ proc$ures  7,a7 ,rese>*] ) a   
curr5t s*$ule ,i or ,,ii rese>*         
regi/ration  7i7 ,9 g5]al ,if a         
practition] is regi/]$ to conduct rese>*
 ) a controll$ sub/ance 9 s*$ule ,i or  
,,ii1 ! practition] may conduct rese>*  
"u ?is subsection on & aft] ! date t is 
#cj days aft] ! date on :i* !           
practition] s5ds a notice to ! ,attorney
 ,g5]al conta9+ ! foll[+ in=mation1 )   
respect to ea* sub/ance ) :i* !         
practition] w conduct ! rese>*3 7,i7 ,! 
*emical "n ( ! sub/ance4  7,,ii7 ,!     
quantity ( ! sub/ance to be us$ 9 !     
rese>*4  7,,iii7 ,demon/ration t !      
rese>* is 9 ! category describ$ 9       
p>agraph 7#b71 :i* demon/ration may be  

satisfi$-- 7aa7 9 ! case ( a grant1     
contract1 coop]ative agreem5t1 or o!r   
transaction1 or intramural rese>*       
project1 by id5tify+ ! sponsor+ ag5cy & 
supply+ ! numb] ( ! grant1 contract1    
coop]ative agreem5t1 o!r transaction1 or
 project2 or  7bb7 9 ! case ( an        
application "u section #eje7;i7 ( !     
,f$]al ,food1 ,drug1 & ,cosmetic ,act   
7#ba ,u4,s4,c4 #cee7;i771 by supply+ !  
application numb] & ! sponsor ( record  
on ! application4  7,,iv7 ,demon/ration 
t ! rese>*] is au?oriz$ to conduct      
rese>* ) respect to ! sub/ance "u ! laws
 ( ! ,/ate 9 :i* ! rese>* w take place4 
7ii7 ,v]ification ( in=mation by ,,hhs  
or ,,va ,^u reque/ f ! ,attorney ,g5]al1
 ! ,secret>y ( ,heal? & ,human ,s]vices1
 ! ,dep>tm5t ( ,def5se1 or ! ,secret>y (
 ,vet]ans ,affairs1 z appropriate1 %all 
v]ify in=mation submitt$ by an applicant
 "u clause 7i77,,iii74  7,b7 ,rese>*]   
)\t a curr5t s*$ule ,i or ,,ii rese>*   
regi/ration  7i7 ,9 g5]al ,if a         
practition] is n regi/]$ to conduct     

rese>* ) a controll$ sub/ance 9 s*$ule  
,i or ,,ii1 ! practition] may s5d a     
notice to ! ,attorney ,g5]al conta9+ !  
in=mation li/$ 9 subp>agraph 7,a77i71 ) 
respect to ea* sub/ance ) :i* !         
practition] w conduct ! rese>*4  7ii7   
,attorney ,g5]al action ,! ,attorney    
,g5]al %all-- 7,i7 treat notice receiv$ 
"u clause 7i7 z a suffici5t application 
= a rese>* regi/ration2 &  7,,ii7 n lat]
 ?an #de days ( receiv+ su* a notice t  
conta9s all in=mation requir$ "u        
subp>agraph 7,a77i7-- 7aa7 regi/] !     
applicant2 or  7bb7 s]ve an ord] to %[  
cause ^u ! applicant 9 accordance )     
section #cjd7;c74  7#d7 ,electronic     
submissions ,! ,attorney ,g5]al %all    
provide a means to p]mit a practition]  
to submit a notification "u p>agraph    
7#c7 electronically4  7#e7 ,limitation  
on am\nts ,a practition] conduct+ rese>*
 ) a s*$ule ,i sub/ance "u ?is          
subsection may only possess ! am\nts (  
s*$ule ,i sub/ance id5tifi$ 9-- 7,a7 !  
notification to ! ,attorney ,g5]al "u   

p>agraph 7#c72 or  7,b7 a supplem5tal   
notification t ! practition] may s5d if 
! practition] ne$s additional am\nts = !
 rese>*1 :i* supplem5tal notification   
%all include-- 7i7 ! "n ( ! practition]2
  7ii7 ! additional quantity ne$$ ( !   
sub/ance2 &  7iii7 an atte/ation t !    
rese>* to be conduct$ ) ! sub/ance is   
consi/5t ) ! scope ( ! rese>* t 0 !     
subject ( ! notification "u p>agraph    
7#c74  7#f7 ,importation & exportation  
requirem5ts n affect$ ,no?+ 9 ?is       
subsection alt]s ! requirem5ts ( "p ,a (
 title ,,iii1 reg>d+ ! importation &    
exportation ( controll$ sub/ances4  7#g7
 ,inspector ,g5]al report ,n lat] ?an #a
 ye> aft] ! date ( enactm5t ( ! ,halt   
,all ,le?al ,traffick+ ( ,f5tanyl ,act1 
! ,inspector ,g5]al ( ! ,dep>tm5t (     
,ju/ice %all complete a /udy1 & submit  
to ,congress a report !reon1 ab\t rese>*
 describ$ 9 p>agraph 7#b7 ( ?is         
subsection ) f5tanyl4  4  7b7 ,sep>ate  
regi/rations n requir$ = additional     
rese>*] 9 same in/itution  7#a7 ,9 g5]al

 ,section #cjb7;c7 ( ! ,controll$       
,sub/ances ,act 7#ba ,u4,s4,c4 #hbb7;c77
 is am5d$ by add+ at ! end ! foll[+3    
7#d7 ,an ag5t or employee ( a rese>*    
in/itution t is conduct+ rese>* ) a     
controll$ sub/ance if-- 7,a7 ! ag5t or  
employee is act+ )9 ! scope ( !         
pr(essional practice ( ! ag5t or        
employee2  7,b7 ano!r ag5t or employee (
 ! in/itution is regi/]$ to conduct     
rese>* ) a controll$ sub/ance 9 ! same  
s*$ule2  7,c7 ! rese>*] :o is s         
regi/]$-- 7i7 in=ms ! ,attorney ,g5]al (
 ! "n1 position title1 & employ+        
in/itution ( ! ag5t or employee :o is n 
sep>ately regi/]$2  7ii7 au?orizes t    
ag5t or employee to p]=m rese>* "u !    
regi/ration ( ! regi/]$ rese>*]2 &      
7iii7 affirms t any act tak5 by t ag5t  
or employee involv+ a controll$ sub/ance
 %all be attributable to ! regi/]$      
rese>*]1 z if ! rese>*] _h directly     
committ$ ! act1 = purposes ( any proce$+
 "u section #cjd7;a7 to susp5d or revoke
 ! regi/ration ( ! regi/]$ rese>*]2 &   

7,d7 ! ,attorney ,g5]al does n1 )9 #cj  
days ( receiv+ ! in=mation1             
au?orization1 & affirmation describ$ 9  
subp>agraph 7,c71 refuse1 = a reason    
li/$ 9 section #cjd7;a71 to all[ ! ag5t 
or employee to possess ! sub/ance )\t a 
sep>ate regi/ration4  4  7#b7 ,te*nical 
correction ,section #cjb7;c77#c7 ( !    
,controll$ ,sub/ances ,act 7#ba         
,u4,s4,c4 #hbb7;c77#c77 is am5d$ by     
/rik+ 7#be7 & ins]t+ 7#bg74  7c7 ,s+le  
regi/ration = relat$ rese>* sites       
,section #cjb7;e7 ( ! ,controll$        
,sub/ances ,act 7#ba ,u4,s4,c4 #hbb7;e77
 is am5d$ by add+ at ! end ! foll[+3    
7#d7 7,a7 ,not)/&+ p>agraph 7#a71 a     
p]son regi/]$ to conduct rese>* ) a     
controll$ sub/ance "u section #cjc7;g7  
may conduct ! rese>* "u a s+le          
regi/ration if-- 7i7 ! rese>* occurs    
exclusively on sites all ( :i* are--    
7,i7 )9 ! same city or c\nty2 &  7,,ii7 
"u ! control ( ! same in/itution1       
organization1 or ag5cy2 &  7ii7 be=e    
comm5c+ ! rese>*1 ! rese>*] notifies !  

,attorney ,g5]al ( ea* site :]e-- 7,i7 !
 rese>* w be conduct$2 or  7,,ii7 !     
controll$ sub/ance w be /or$ or         
adm9i/]$4  7,b7 ,a site describ$ 9      
subp>agraph 7,a7 %all be includ$ 9 a    
regi/ration describ$ 9 t subp>agraph    
only if ! rese>*] has notifi$ !         
,attorney ,g5]al ( ! site-- 7i7 9 !     
application = ! regi/ration2 or  7ii7   
be=e ! rese>* is conduct$1 or be=e !    
controll$ sub/ance is /or$ or adm9i/]$1 
at ! site4  7,c7 ,! ,attorney ,g5]al    
may1 9 consultation ) ! ,secret>y1 issue
 regulations address+1 ) respect to     
rese>* sites describ$ 9 subp>agraph     
7,a7-- 7i7 ! mann] 9 :i* controll$      
sub/ances may be deliv]$ to ! rese>*    
sites2  7ii7 ! /orage & security (      
controll$ sub/ances at ! rese>* sites2  
7iii7 ! ma9t5ance ( records = ! rese>*  
sites2 &  7iv7 any o!r matt]s necess>y  
to ensure effective controls aga9/      
div]sion at ! rese>* sites4  4  7d7 ,new
 inspection n requir$ 9 c]ta9 situations
 ,section #cjb7;f7 ( ! ,controll$       

,sub/ances ,act 7#ba ,u4,s4,c4 #hbb7;f77
 is am5d$-- 7#a7 by /rik+ 7f7 ,! &      
ins]t+ 7f77#a7 ,!2 &  7#b7 by add+ at ! 
end ! foll[+3  7#b7 7,a7 ,if a p]son is 
regi/]$ to conduct rese>* ) a controll$ 
sub/ance & applies = a regi/ration1 or =
 a modification ( a regi/ration1 to     
conduct rese>* ) a second controll$     
sub/ance t is 9 ! same s*$ule z ! fir/  
controll$ sub/ance1 or is 9 a s*$ule ) a
 high] num]ical designation ?an ! s*$ule
 ( ! fir/ controll$ sub/ance1 a new     
inspection by ! ,attorney ,g5]al ( !    
regi/]$ location is n requir$4  7,b7    
,no?+ 9 subp>agraph 7,a7 %all prohibit !
 ,attorney ,g5]al f conduct+ an         
inspection t ! ,attorney ,g5]al det]m9es
 necess>y to ensure t a regi/rant       
ma9ta9s effective controls aga9/        
div]sion4  4  7e7 ,cont9uation ( rese>* 
on sub/ances newly add$ to s*$ule ,i    
,section #cjb ( ! ,controll$ ,sub/ances 
,act 7#ba ,u4,s4,c4 #hbb7 is am5d$ by   
add+ at ! end ! foll[+3  7h7            
,cont9uation ( rese>* on sub/ances newly

 add$ to s*$ule ,i ,if a p]son is       
conduct+ rese>* on a sub/ance :5 !      
sub/ance is add$ to s*$ule ,i1 & ! p]son
 is already regi/]$ to conduct rese>* ) 
a controll$ sub/ance 9 s*$ule ,i-- 7#a7 
n lat] ?an #ij days aft] ! s*$ul+ ( !   
newly s*$ul$ sub/ance1 ! p]son %all     
submit a complet$ application =         
regi/ration or modification ( exi/+     
regi/ration1 to conduct rese>* on !     
sub/ance1 9 accordance ) regulations    
issu$ by ! ,attorney ,g5]al = purposes (
 ?is p>agraph2  7#b7 ! p]son may1       
not)/&+ subsections 7a7 & 7b71 cont9ue  
to conduct ! rese>* on ! sub/ance       
until-- 7,a7 ! p]son )draws !           
application describ$ 9 p>agraph 7#a7 (  
?is subsection2 or  7,b7 ! ,attorney    
,g5]al s]ves on ! p]son an ord] to %[   
cause propos+ ! d5ial ( ! application "u
 section #cjd7;c72  7#c7 if ! ,attorney 
,g5]al s]ves an ord] to %[ cause z      
describ$ 9 p>agraph 7#b77;,b7 & ! p]son 
reque/s a he>+1 ! he>+ %all be held on  
an exp$it$ basis & n lat] ?an #de days  

aft] ! reque/ is made1 except t ! he>+  
may be held at a lat] "t if s reque/$ by
 ! p]son2 &  7#d7 if ! p]son s5ds a copy
 ( ! application describ$ 9 p>agraph    
7#a7 to a manufactur] or di/ributor ( ! 
sub/ance1 receipt ( ! copy by !         
manufactur] or di/ributor %all con/itute
 suffici5t evid5ce t ! p]son is au?oriz$
 to receive ! sub/ance4  4  7f7         
,treatm5t ( c]ta9 manufactur+ activities
 z co9cid5t to rese>* ,section #cjb ( ! 
,controll$ ,sub/ances ,act 7#ba         
,u4,s4,c4 #hbb71 z am5d$ by subsection  
7e71 is am5d$ by add+ at ! end ! foll[+3
  7i7 ,treatm5t ( c]ta9 manufactur+     
activities z co9cid5t to rese>*  7#a7 ,9
 g5]al ,except z provid$ 9 p>agraph     
7#c71 a p]son :o is regi/]$ to p]=m     
rese>* on a controll$ sub/ance may p]=m 
manufactur+ activities ) small          
quantities ( t sub/ance1 includ+        
activities describ$ 9 p>agraph 7#b71 )\t
 be+ requir$ to obta9 a manufactur+     
regi/ration1 if-- 7,a7 ! activities are 
p]=m$ = ! purpose ( ! rese>*2 &  7,b7 ! 

activities & ! quantities ( ! sub/ance  
involv$ 9 ! activities are /at$ 9-- 7i7 
a notification submitt$ to ! ,attorney  
,g5]al "u section #cjc7n72  7ii7 a      
rese>* protocol fil$ ) an application = 
regi/ration approval "u section         
#cjc7;g72 or  7iii7 a notification to ! 
,attorney ,g5]al t includes-- 7,i7 ! "n 
( ! regi/rant2 &  7,,ii7 an atte/ation t
 ! rese>* to be conduct$ ) ! small      
quantities ( manufactur$ sub/ance is    
consi/5t ) ! scope ( ! rese>* t is !    
basis = ! regi/ration4  7#b7 ,activities
 includ$ ,activities p]mitt$ "u p>agraph
 7#a7 include-- 7,a7 process+ ! sub/ance
 to create extracts1 t9ctures1 oils1    
solutions1 d]ivatives1 or o!r =ms ( !   
sub/ance consi/5t )-- 7i7 ! in=mation   
provid$ z "p ( a notification submitt$  
to ! ,attorney ,g5]al "u section        
#cjc7n72 or  7ii7 a rese>* protocol fil$
 ) an application = regi/ration approval
 "u section #cjc7;g72 &  7,b7 dosage =m 
developm5t /udies p]=m$ = ! purpose (   
reque/+ an inve/igational new drug      

exemption "u section #eje7;i7 ( ! ,f$]al
 ,food1 ,drug1 & ,cosmetic ,act 7#ba    
,u4,s4,c4 #cee7;i774  7#c7 ,exception   
reg>d+ m>ihuana ,! au?ority "u p>agraph 
7#a7 to manufacture sub/ances does n    
include ! au?ority to gr[ m>ihuana4  4  
7g7 ,transp>5cy reg>d+ special proc$ures
 ,section #cjc ( ! ,controll$ ,sub/ances
 ,act 7#ba ,u4,s4,c4 #hbc71 z am5d$ by  
subsection 7a71 is am5d$ by add+ at !   
end ! foll[+3  7o7 ,transp>5cy reg>d+   
special proc$ures  7#a7 ,9 g5]al ,if !  
,attorney ,g5]al det]m9es1 ) respect to 
a controll$ sub/ance1 t an application  
by a practition] to conduct rese>* ) !  
sub/ance %\ld be consid]$ "u a process1 
or subject to crit]ia1 diff]5t f !      
process or crit]ia applicable to        
applications to conduct rese>* ) o!r    
controll$ sub/ances 9 ! same s*$ule1 !  
,attorney ,g5]al %all make public1      
includ+ by po/+ on ! website ( ! ,drug  
,en=cem5t ,adm9i/ration-- 7,a7 !        
id5tities ( all sub/ances = :i* su*     
det]m9ations h be5 made2  7,b7 ! process

 & crit]ia t %all be appli$ to          
applications to conduct rese>* ) ^?     
sub/ances2 &  7,c7 h[ ! process &       
crit]ia describ$ 9 subp>agraph 7,b7     
diff] f ! process & crit]ia applicable  
to applications to conduct rese>* ) o!r 
controll$ sub/ances 9 ! same s*$ule4    
7#b7 ,tim+ ( po/+ ,! ,attorney ,g5]al   
%all make in=mation describ$ 9 p>agraph 
7#a7 public ^u mak+ a det]m9ation       
describ$ 9 t p>agraph1 reg>dless ( :e!r 
a practition] has submitt$ su* an       
application at t "t4  4  #d4 ,te*nical  
correction on controll$ sub/ances       
disp5s+ ,effective z if includ$ 9 !     
enactm5t ( ,public ,law #aag-cbh-- 7#a7 
section #abeb7;a7 ( division ,,ff (     
,public ,law #aag-cbh 7#acf ,/at4 #efha7
 is am5d$1 9 ! matt] be+ ins]t$ into    
section #cjb7;e7 ( ! ,controll$         
,sub/ances ,act1 by /rik+ #cjc7;g7 &    
ins]t+ #cjc7;h72  7#b7 section #abfb (  
division ,,ff ( ,public ,law #aag-cbh   
7#acf ,/at4 #efha7 is am5d$-- 7,a7 9    
subsection 7a7-- 7i7 9 ! matt] prec$+   

p>agraph 7#a71 by /rik+ #cjc7;g7 &      
ins]t+ #cjc7;h72  7ii7 9 ! matt] be+    
/rick5 by subsection 7a77#b71 by /rik+  
7g77#a7 & ins]t+ 7h77#a72 &  7iii7 9 !  
matt] be+ ins]t$ by subsection 7a77#b71 
by /rik+ 7g7 ,practition]s & ins]t+ 7h7 
,practition]s2 &  7,b7 9 subsection     
7b7-- 7i7 9 ! matt] be+ /rick5 by       
p>agraph 7#a71 by /rik+ #cjc7;g77#a7 &  
ins]t+ #cjc7;h77#a72  7ii7 9 ! matt] be+
 ins]t$ by p>agraph 7#a71 by /rik+      
#cjc7;g7 & ins]t+ #cjc7;h72  7iii7 9 !  
matt] be+ /rick5 by p>agraph 7#b77;,a71 
by /rik+ #cjc7;g77#b7 & ins]t+          
#cjc7;h77#b72  7iv7 9 ! matt] be+ /rick5
 by p>agraph 7#c71 by /rik+             
#cjc7;g77#b77;,b7 & ins]t+              
#cjc7;h77#b77;,b72  7v7 9 ! matt] be+   
/rick5 by p>agraph 7#e71 by /rik+       
#cjc7;g7 & ins]t+ #cjc7;h72 &  7vi7 9 ! 
matt] be+ /rick5 by p>agraph 7#f71 by   
/rik+ #cjc7;g7 & ins]t+ #cjc7;h72 &     
7#c7 section #abfc7;b7 ( division ,,ff (
 ,public ,law #aag-cbh 7#acf ,/at4      
#efhe7 is am5d$-- 7,a7 by /rik+         

#cjc7;g77#b7 & ins]t+ #cjc7;h77#b72 &   
7,b7 by /rik+ 7#ba ,u4,s4,c4            
#hbc7;g77#b77 & ins]t+ 7#ba ,u4,s4,c4   
#hbc7;h77#b774  #e4 ,rulemak+  7a7      
,int]im f9al rules ,! ,attorney ,g5]al--
 7#a7 %all1 n lat] ?an #f mon?s aft] !  
date ( enactm5t ( ?is ,act1 issue rules 
to implem5t ?is ,act & ! am5dm5ts made  
by ?is ,act2 &  7#b7 may issue ! rules  
"u p>agraph 7#a7 z int]im f9al rules4   
7b7 ,proc$ure = f9al rule  7#a7         
,effectiv5ess ( int]im f9al rules ,a    
rule issu$ by ! ,attorney ,g5]al z an   
int]im f9al rule "u subsection 7a7 %all 
become imm$iately effective z an int]im 
f9al rule )\t requir+ ! ,attorney ,g5]al
 to demon/rate good cause !re=1 not)/&+ 
subp>agraph 7,b7 ( section #eec7;b7 (   
title #e1 ,unit$ ,/ates ,code4  7#b7    
,opportunity = comm5t & he>+ ,an int]im 
f9al rule issu$ "u subsection 7a7 %all  
give int]e/$ p]sons ! opportunity to    
comm5t & to reque/ a he>+4  7#c7 ,f9al  
rule ,aft] ! conclusion ( su* proce$+s1 
! ,attorney ,g5]al %all issue a f9al    

rule to implem5t ?is ,act & ! am5dm5ts  
made by ?is ,act 9 accordance ) section 
#eec ( title #e1 ,unit$ ,/ates ,code4   
#f4 ,p5alties  7a7 ,9 g5]al ,section    
#dja7;b77#a7 ( ! ,controll$ ,sub/ances  
,act 7#ba ,u4,s4,c4 #hda7;b77#a77 is    
am5d$-- 7#a7 9 subp>agraph 7,a77vi71 by 
ins]t+ or a f5tanyl-relat$ sub/ance aft]
 any analogue (                         
,n-ph5yl-,n-#a-7b-ph5yle?yl7-#d-pip]id9y
l propanamide2 &  7#b7 9 subp>agraph    
7,b77vi71 by ins]t+ or a f5tanyl-relat$ 
sub/ance aft] any analogue (            
,n-ph5yl-,n-#a-7b-ph5yle?yl7-#d-pip]id9y
l propanamide4  7b7 ,importation &      
exportation ,section #ajaj7;b7 ( !      
,controll$ ,sub/ances ,import & ,export 
,act 7#ba ,u4,s4,c4 #ifj7;b77 is am5d$--
 7#a7 9 p>agraph 7#a77;,f71 by ins]t+ or
 a f5tanyl-relat$ sub/ance aft] any     
analogue (                              
,n-ph5yl-,n-#a-7b-ph5yle?yl7-#d-pip]id9y
l propanamide2 &  7#b7 9 p>agraph       
7#b77;,f71 by ins]t+ or a f5tanyl-relat$
 sub/ance aft] any analogue (           

,n-ph5yl-,n-#a-7b-ph5yle?yl7-#d-pip]id9y
l propanamide4  7c7 ,def9ition (        
f5tanyl-,relat$ sub/ance ,section #ajb (
 ! ,controll$ ,sub/ances ,act 7#ba      
,u4,s4,c4 #hjb7 is am5d$ by add+ at !   
end ! foll[+3  7#fj7 ,! t]m             
f5tanyl-relat$ sub/ance has ! mean+ giv5
 ! t]m 9 subsection 7e77#b7 ( s*$ule ,i 
( section #bjb7;c74  4  #g4             
,applicability2 o!r matt]s  7a7 ,9 g5]al
 ,irrespective ( ! date on :i* ! rules  
requir$ by section #d are f9aliz$1 !    
am5dm5ts made by ?is ,act apply beg9n+ z
 ( ! date ( enactm5t ( ?is ,act4  7b7   
,rule ( con/ruction ,no?+ 9 ! am5dm5ts  
made by ?is ,act may be con/ru$ z       
evid5ce t1 9 apply+ sections            
#dja7;b77#a7 & #ajaj7;b7 ( ! ,controll$ 
,sub/ances ,act 7#ba ,u4,s4,c4          
#hda7;b77#a71 #ifj7;b77 ) respect to    
conduct occurr+ be=e ! date ( ! enactm5t
 ( ?is ,act1 a f5tanyl-relat$ sub/ance  
7z def9$ by su* am5dm5ts7 is n an       
analogue (                              
,n-ph5yl-,n-#a-7b-ph5yle?yl7-#d-pip]id9y

l propanamide4  7c7 ,s5se ( ,congress   
,congress agrees ) ! int]pretation ( !  
,controll$ ,sub/ances ,act 7#ba         
,u4,s4,c4 #hja et seq47 9 ,unit$ ,/ates 
v4 ,mc,cray1 #cdf ,f4 ,supp4 #c;d #cfc  
7,w4,d4,n4,y4 #bjah74  #a4 ,%ort title  
,?is ,act may be cit$ z ! ,halt ,all    
,le?al ,traffick+ ( ,f5tanyl ,act or !  
,,halt ,f5tanyl ,act4  #b4 ,class s*$ul+
 ( f5tanyl-relat$ sub/ances ,section    
#bjb7;c7 ( ! ,controll$ ,sub/ances ,act 
7#ba ,u4,s4,c4 #hab7;c77 is am5d$ by    
add+ at ! end ( s*$ule ,i ! foll[+3  7e7
 7#a7 ,unless specifically exempt$ or   
unless li/$ 9 ano!r s*$ule1 any mat]ial1
 comp\nd1 mixture1 or prep>ation :i*    
conta9s any quantity ( a f5tanyl-relat$ 
sub/ance1 or :i* conta9s ! salts1       
isom]s1 & salts ( isom]s ( a            
f5tanyl-relat$ sub/ance :5ev] ! exi/5ce 
( su* salts1 isom]s1 & salts ( isom]s is
 possible )9 ! specific *emical         
designation4  7#b7 ,= purposes (        
p>agraph 7#a71 except z provid$ 9       
p>agraph 7#c71 ! t]m f5tanyl-relat$     

sub/ance means any sub/ance t is        
/ructurally relat$ to f5tanyl by #a or m
 ( ! foll[+ modifications3 7,a7 ,by     
replacem5t ( ! ph5yl portion ( ! ph5e?yl
 gr\p by any monocycle1 :e!r or n fur!r 
sub/itut$ 9 or on ! monocycle4  7,b7 ,by
 sub/itution 9 or on ! ph5e?yl gr\p )   
alkyl1 alk5yl1 alkoxyl1 hydroxyl1 halo1 
haloalkyl1 am9o1 or nitro gr\ps4  7,c7  
,by sub/itution 9 or on ! pip]id9e r+ ) 
alkyl1 alk5yl1 alkoxyl1 e/]1 e!r1       
hydroxyl1 halo1 haloalkyl1 am9o1 or     
nitro gr\ps4  7,d7 ,by replacem5t ( !   
anil9e r+ ) any aromatic monocycle :e!r 
or n fur!r sub/itut$ 9 or on ! aromatic 
monocycle4  7,e7 ,by replacem5t ( !     
,n-propionyl gr\p ) ano!r acyl gr\p4    
7#c7 ,a sub/ance t satisfies ! def9ition
 ( ! t]m f5tanyl-relat$ sub/ance 9      
p>agraph 7#b7 %all none!less n be treat$
 z a f5tanyl-relat$ sub/ance subject to 
?is s*$ule if ! sub/ance-- 7,a7 is      
controll$ by action ( ! ,attorney ,g5]al
 "u section #bja2 or  7,b7 is o!rwise   
expressly li/$ 9 a s*$ule o!r ?an ?is   

s*$ule4  7#d7 7,a7 ,! ,attorney ,g5]al  
may by ord] publi% 9 ! ,f$]al ,regi/] a 
li/ ( sub/ances t satisfy ! def9ition ( 
! t]m f5tanyl-relat$ sub/ance 9 p>agraph
 7#b74  7,b7 ,! abs5ce ( a sub/ance f a 
li/ publi%$ "u subp>agraph 7,a7 does n  
negate ! control /atus ( ! sub/ance "u  
?is s*$ule if ! sub/ance satisfies !    
def9ition ( ! t]m f5tanyl-relat$        
sub/ance 9 p>agraph 7#b74  4  #c4       
,regi/ration requirem5ts relat$ to      
rese>*  7a7 ,alt]native regi/ration     
process = s*$ule ,i rese>* ,section #cjc
 ( ! ,controll$ ,sub/ances ,act 7#ba    
,u4,s4,c4 #hbc7 is am5d$-- 7#a7 by      
r$esignat+ ! second subsection 7l7      
7relat+ to requir$ tra9+ = prescrib]s7 z
 subsection 7m72 &  7#b7 by add+ at !   
end ! foll[+3  7n7 ,special provisions =
 practition]s conduct+ c]ta9 rese>* )   
s*$ule ,i controll$ sub/ances  7#a7 ,9  
g5]al ,not)/&+ subsection 7g71 a        
practition] may conduct rese>* describ$ 
9 p>agraph 7#b7 ( ?is subsection ) #a or
 m s*$ule ,i sub/ances 9 accordance )   

subp>agraph 7,a7 or 7,b7 ( p>agraph 7#c7
 ( ?is subsection4  7#b7 ,rese>* subject
 to exp$it$ proc$ures ,rese>* describ$ 9
 ?is p>agraph is rese>* t-- 7,a7 is )   
respect to a drug t is ! subject ( an   
inve/igational use exemption "u section 
#eje7;i7 ( ! ,f$]al ,food1 ,drug1 &     
,cosmetic ,act 7#ba ,u4,s4,c4 #cee7;i772
 or  7,b7 is-- 7i7 conduct$ by !        
,dep>tm5t ( ,heal? & ,human ,s]vices1 ! 
,dep>tm5t ( ,def5se1 or ! ,dep>tm5t (   
,vet]ans ,affairs2 or  7ii7 fund$ p>tly 
or entirely by a grant1 contract1       
coop]ative agreem5t1 or o!r transaction 
f ! ,dep>tm5t ( ,heal? & ,human         
,s]vices1 ! ,dep>tm5t ( ,def5se1 or !   
,dep>tm5t ( ,vet]ans ,affairs4  7#c7    
,exp$it$ proc$ures  7,a7 ,rese>*] ) a   
curr5t s*$ule ,i or ,,ii rese>*         
regi/ration  7i7 ,9 g5]al ,if a         
practition] is regi/]$ to conduct rese>*
 ) a controll$ sub/ance 9 s*$ule ,i or  
,,ii1 ! practition] may conduct rese>*  
"u ?is subsection on & aft] ! date t is 
#cj days aft] ! date on :i* !           

practition] s5ds a notice to ! ,attorney
 ,g5]al conta9+ ! foll[+ in=mation1 )   
respect to ea* sub/ance ) :i* !         
practition] w conduct ! rese>*3 7,i7 ,! 
*emical "n ( ! sub/ance4  7,,ii7 ,!     
quantity ( ! sub/ance to be us$ 9 !     
rese>*4  7,,iii7 ,demon/ration t !      
rese>* is 9 ! category describ$ 9       
p>agraph 7#b71 :i* demon/ration may be  
satisfi$-- 7aa7 9 ! case ( a grant1     
contract1 coop]ative agreem5t1 or o!r   
transaction1 or intramural rese>*       
project1 by id5tify+ ! sponsor+ ag5cy & 
supply+ ! numb] ( ! grant1 contract1    
coop]ative agreem5t1 o!r transaction1 or
 project2 or  7bb7 9 ! case ( an        
application "u section #eje7;i7 ( !     
,f$]al ,food1 ,drug1 & ,cosmetic ,act   
7#ba ,u4,s4,c4 #cee7;i771 by supply+ !  
application numb] & ! sponsor ( record  
on ! application4  7,,iv7 ,demon/ration 
t ! rese>*] is au?oriz$ to conduct      
rese>* ) respect to ! sub/ance "u ! laws
 ( ! ,/ate 9 :i* ! rese>* w take place4 
7ii7 ,v]ification ( in=mation by ,,hhs  

or ,,va ,^u reque/ f ! ,attorney ,g5]al1
 ! ,secret>y ( ,heal? & ,human ,s]vices1
 ! ,dep>tm5t ( ,def5se1 or ! ,secret>y (
 ,vet]ans ,affairs1 z appropriate1 %all 
v]ify in=mation submitt$ by an applicant
 "u clause 7i77,,iii74  7,b7 ,rese>*]   
)\t a curr5t s*$ule ,i or ,,ii rese>*   
regi/ration  7i7 ,9 g5]al ,if a         
practition] is n regi/]$ to conduct     
rese>* ) a controll$ sub/ance 9 s*$ule  
,i or ,,ii1 ! practition] may s5d a     
notice to ! ,attorney ,g5]al conta9+ !  
in=mation li/$ 9 subp>agraph 7,a77i71 ) 
respect to ea* sub/ance ) :i* !         
practition] w conduct ! rese>*4  7ii7   
,attorney ,g5]al action ,! ,attorney    
,g5]al %all-- 7,i7 treat notice receiv$ 
"u clause 7i7 z a suffici5t application 
= a rese>* regi/ration2 &  7,,ii7 n lat]
 ?an #de days ( receiv+ su* a notice t  
conta9s all in=mation requir$ "u        
subp>agraph 7,a77i7-- 7aa7 regi/] !     
applicant2 or  7bb7 s]ve an ord] to %[  
cause ^u ! applicant 9 accordance )     
section #cjd7;c74  7#d7 ,electronic     

submissions ,! ,attorney ,g5]al %all    
provide a means to p]mit a practition]  
to submit a notification "u p>agraph    
7#c7 electronically4  7#e7 ,limitation  
on am\nts ,a practition] conduct+ rese>*
 ) a s*$ule ,i sub/ance "u ?is          
subsection may only possess ! am\nts (  
s*$ule ,i sub/ance id5tifi$ 9-- 7,a7 !  
notification to ! ,attorney ,g5]al "u   
p>agraph 7#c72 or  7,b7 a supplem5tal   
notification t ! practition] may s5d if 
! practition] ne$s additional am\nts = !
 rese>*1 :i* supplem5tal notification   
%all include-- 7i7 ! "n ( ! practition]2
  7ii7 ! additional quantity ne$$ ( !   
sub/ance2 &  7iii7 an atte/ation t !    
rese>* to be conduct$ ) ! sub/ance is   
consi/5t ) ! scope ( ! rese>* t 0 !     
subject ( ! notification "u p>agraph    
7#c74  7#f7 ,importation & exportation  
requirem5ts n affect$ ,no?+ 9 ?is       
subsection alt]s ! requirem5ts ( "p ,a (
 title ,,iii1 reg>d+ ! importation &    
exportation ( controll$ sub/ances4  7#g7
 ,inspector ,g5]al report ,n lat] ?an #a

 ye> aft] ! date ( enactm5t ( ! ,halt   
,all ,le?al ,traffick+ ( ,f5tanyl ,act1 
! ,inspector ,g5]al ( ! ,dep>tm5t (     
,ju/ice %all complete a /udy1 & submit  
to ,congress a report !reon1 ab\t rese>*
 describ$ 9 p>agraph 7#b7 ( ?is         
subsection ) f5tanyl4  4  7b7 ,sep>ate  
regi/rations n requir$ = additional     
rese>*] 9 same in/itution  7#a7 ,9 g5]al
 ,section #cjb7;c7 ( ! ,controll$       
,sub/ances ,act 7#ba ,u4,s4,c4 #hbb7;c77
 is am5d$ by add+ at ! end ! foll[+3    
7#d7 ,an ag5t or employee ( a rese>*    
in/itution t is conduct+ rese>* ) a     
controll$ sub/ance if-- 7,a7 ! ag5t or  
employee is act+ )9 ! scope ( !         
pr(essional practice ( ! ag5t or        
employee2  7,b7 ano!r ag5t or employee (
 ! in/itution is regi/]$ to conduct     
rese>* ) a controll$ sub/ance 9 ! same  
s*$ule2  7,c7 ! rese>*] :o is s         
regi/]$-- 7i7 in=ms ! ,attorney ,g5]al (
 ! "n1 position title1 & employ+        
in/itution ( ! ag5t or employee :o is n 
sep>ately regi/]$2  7ii7 au?orizes t    

ag5t or employee to p]=m rese>* "u !    
regi/ration ( ! regi/]$ rese>*]2 &      
7iii7 affirms t any act tak5 by t ag5t  
or employee involv+ a controll$ sub/ance
 %all be attributable to ! regi/]$      
rese>*]1 z if ! rese>*] _h directly     
committ$ ! act1 = purposes ( any proce$+
 "u section #cjd7;a7 to susp5d or revoke
 ! regi/ration ( ! regi/]$ rese>*]2 &   
7,d7 ! ,attorney ,g5]al does n1 )9 #cj  
days ( receiv+ ! in=mation1             
au?orization1 & affirmation describ$ 9  
subp>agraph 7,c71 refuse1 = a reason    
li/$ 9 section #cjd7;a71 to all[ ! ag5t 
or employee to possess ! sub/ance )\t a 
sep>ate regi/ration4  4  7#b7 ,te*nical 
correction ,section #cjb7;c77#c7 ( !    
,controll$ ,sub/ances ,act 7#ba         
,u4,s4,c4 #hbb7;c77#c77 is am5d$ by     
/rik+ 7#be7 & ins]t+ 7#bg74  7c7 ,s+le  
regi/ration = relat$ rese>* sites       
,section #cjb7;e7 ( ! ,controll$        
,sub/ances ,act 7#ba ,u4,s4,c4 #hbb7;e77
 is am5d$ by add+ at ! end ! foll[+3    
7#d7 7,a7 ,not)/&+ p>agraph 7#a71 a     

p]son regi/]$ to conduct rese>* ) a     
controll$ sub/ance "u section #cjc7;g7  
may conduct ! rese>* "u a s+le          
regi/ration if-- 7i7 ! rese>* occurs    
exclusively on sites all ( :i* are--    
7,i7 )9 ! same city or c\nty2 &  7,,ii7 
"u ! control ( ! same in/itution1       
organization1 or ag5cy2 &  7ii7 be=e    
comm5c+ ! rese>*1 ! rese>*] notifies !  
,attorney ,g5]al ( ea* site :]e-- 7,i7 !
 rese>* w be conduct$2 or  7,,ii7 !     
controll$ sub/ance w be /or$ or         
adm9i/]$4  7,b7 ,a site describ$ 9      
subp>agraph 7,a7 %all be includ$ 9 a    
regi/ration describ$ 9 t subp>agraph    
only if ! rese>*] has notifi$ !         
,attorney ,g5]al ( ! site-- 7i7 9 !     
application = ! regi/ration2 or  7ii7   
be=e ! rese>* is conduct$1 or be=e !    
controll$ sub/ance is /or$ or adm9i/]$1 
at ! site4  7,c7 ,! ,attorney ,g5]al    
may1 9 consultation ) ! ,secret>y1 issue
 regulations address+1 ) respect to     
rese>* sites describ$ 9 subp>agraph     
7,a7-- 7i7 ! mann] 9 :i* controll$      

sub/ances may be deliv]$ to ! rese>*    
sites2  7ii7 ! /orage & security (      
controll$ sub/ances at ! rese>* sites2  
7iii7 ! ma9t5ance ( records = ! rese>*  
sites2 &  7iv7 any o!r matt]s necess>y  
to ensure effective controls aga9/      
div]sion at ! rese>* sites4  4  7d7 ,new
 inspection n requir$ 9 c]ta9 situations
 ,section #cjb7;f7 ( ! ,controll$       
,sub/ances ,act 7#ba ,u4,s4,c4 #hbb7;f77
 is am5d$-- 7#a7 by /rik+ 7f7 ,! &      
ins]t+ 7f77#a7 ,!2 &  7#b7 by add+ at ! 
end ! foll[+3  7#b7 7,a7 ,if a p]son is 
regi/]$ to conduct rese>* ) a controll$ 
sub/ance & applies = a regi/ration1 or =
 a modification ( a regi/ration1 to     
conduct rese>* ) a second controll$     
sub/ance t is 9 ! same s*$ule z ! fir/  
controll$ sub/ance1 or is 9 a s*$ule ) a
 high] num]ical designation ?an ! s*$ule
 ( ! fir/ controll$ sub/ance1 a new     
inspection by ! ,attorney ,g5]al ( !    
regi/]$ location is n requir$4  7,b7    
,no?+ 9 subp>agraph 7,a7 %all prohibit !
 ,attorney ,g5]al f conduct+ an         

inspection t ! ,attorney ,g5]al det]m9es
 necess>y to ensure t a regi/rant       
ma9ta9s effective controls aga9/        
div]sion4  4  7e7 ,cont9uation ( rese>* 
on sub/ances newly add$ to s*$ule ,i    
,section #cjb ( ! ,controll$ ,sub/ances 
,act 7#ba ,u4,s4,c4 #hbb7 is am5d$ by   
add+ at ! end ! foll[+3  7h7            
,cont9uation ( rese>* on sub/ances newly
 add$ to s*$ule ,i ,if a p]son is       
conduct+ rese>* on a sub/ance :5 !      
sub/ance is add$ to s*$ule ,i1 & ! p]son
 is already regi/]$ to conduct rese>* ) 
a controll$ sub/ance 9 s*$ule ,i-- 7#a7 
n lat] ?an #ij days aft] ! s*$ul+ ( !   
newly s*$ul$ sub/ance1 ! p]son %all     
submit a complet$ application =         
regi/ration or modification ( exi/+     
regi/ration1 to conduct rese>* on !     
sub/ance1 9 accordance ) regulations    
issu$ by ! ,attorney ,g5]al = purposes (
 ?is p>agraph2  7#b7 ! p]son may1       
not)/&+ subsections 7a7 & 7b71 cont9ue  
to conduct ! rese>* on ! sub/ance       
until-- 7,a7 ! p]son )draws !           

application describ$ 9 p>agraph 7#a7 (  
?is subsection2 or  7,b7 ! ,attorney    
,g5]al s]ves on ! p]son an ord] to %[   
cause propos+ ! d5ial ( ! application "u
 section #cjd7;c72  7#c7 if ! ,attorney 
,g5]al s]ves an ord] to %[ cause z      
describ$ 9 p>agraph 7#b77;,b7 & ! p]son 
reque/s a he>+1 ! he>+ %all be held on  
an exp$it$ basis & n lat] ?an #de days  
aft] ! reque/ is made1 except t ! he>+  
may be held at a lat] "t if s reque/$ by
 ! p]son2 &  7#d7 if ! p]son s5ds a copy
 ( ! application describ$ 9 p>agraph    
7#a7 to a manufactur] or di/ributor ( ! 
sub/ance1 receipt ( ! copy by !         
manufactur] or di/ributor %all con/itute
 suffici5t evid5ce t ! p]son is au?oriz$
 to receive ! sub/ance4  4  7f7         
,treatm5t ( c]ta9 manufactur+ activities
 z co9cid5t to rese>* ,section #cjb ( ! 
,controll$ ,sub/ances ,act 7#ba         
,u4,s4,c4 #hbb71 z am5d$ by subsection  
7e71 is am5d$ by add+ at ! end ! foll[+3
  7i7 ,treatm5t ( c]ta9 manufactur+     
activities z co9cid5t to rese>*  7#a7 ,9

 g5]al ,except z provid$ 9 p>agraph     
7#c71 a p]son :o is regi/]$ to p]=m     
rese>* on a controll$ sub/ance may p]=m 
manufactur+ activities ) small          
quantities ( t sub/ance1 includ+        
activities describ$ 9 p>agraph 7#b71 )\t
 be+ requir$ to obta9 a manufactur+     
regi/ration1 if-- 7,a7 ! activities are 
p]=m$ = ! purpose ( ! rese>*2 &  7,b7 ! 
activities & ! quantities ( ! sub/ance  
involv$ 9 ! activities are /at$ 9-- 7i7 
a notification submitt$ to ! ,attorney  
,g5]al "u section #cjc7n72  7ii7 a      
rese>* protocol fil$ ) an application = 
regi/ration approval "u section         
#cjc7;g72 or  7iii7 a notification to ! 
,attorney ,g5]al t includes-- 7,i7 ! "n 
( ! regi/rant2 &  7,,ii7 an atte/ation t
 ! rese>* to be conduct$ ) ! small      
quantities ( manufactur$ sub/ance is    
consi/5t ) ! scope ( ! rese>* t is !    
basis = ! regi/ration4  7#b7 ,activities
 includ$ ,activities p]mitt$ "u p>agraph
 7#a7 include-- 7,a7 process+ ! sub/ance
 to create extracts1 t9ctures1 oils1    

solutions1 d]ivatives1 or o!r =ms ( !   
sub/ance consi/5t )-- 7i7 ! in=mation   
provid$ z "p ( a notification submitt$  
to ! ,attorney ,g5]al "u section        
#cjc7n72 or  7ii7 a rese>* protocol fil$
 ) an application = regi/ration approval
 "u section #cjc7;g72 &  7,b7 dosage =m 
developm5t /udies p]=m$ = ! purpose (   
reque/+ an inve/igational new drug      
exemption "u section #eje7;i7 ( ! ,f$]al
 ,food1 ,drug1 & ,cosmetic ,act 7#ba    
,u4,s4,c4 #cee7;i774  7#c7 ,exception   
reg>d+ m>ihuana ,! au?ority "u p>agraph 
7#a7 to manufacture sub/ances does n    
include ! au?ority to gr[ m>ihuana4  4  
7g7 ,transp>5cy reg>d+ special proc$ures
 ,section #cjc ( ! ,controll$ ,sub/ances
 ,act 7#ba ,u4,s4,c4 #hbc71 z am5d$ by  
subsection 7a71 is am5d$ by add+ at !   
end ! foll[+3  7o7 ,transp>5cy reg>d+   
special proc$ures  7#a7 ,9 g5]al ,if !  
,attorney ,g5]al det]m9es1 ) respect to 
a controll$ sub/ance1 t an application  
by a practition] to conduct rese>* ) !  
sub/ance %\ld be consid]$ "u a process1 

or subject to crit]ia1 diff]5t f !      
process or crit]ia applicable to        
applications to conduct rese>* ) o!r    
controll$ sub/ances 9 ! same s*$ule1 !  
,attorney ,g5]al %all make public1      
includ+ by po/+ on ! website ( ! ,drug  
,en=cem5t ,adm9i/ration-- 7,a7 !        
id5tities ( all sub/ances = :i* su*     
det]m9ations h be5 made2  7,b7 ! process
 & crit]ia t %all be appli$ to          
applications to conduct rese>* ) ^?     
sub/ances2 &  7,c7 h[ ! process &       
crit]ia describ$ 9 subp>agraph 7,b7     
diff] f ! process & crit]ia applicable  
to applications to conduct rese>* ) o!r 
controll$ sub/ances 9 ! same s*$ule4    
7#b7 ,tim+ ( po/+ ,! ,attorney ,g5]al   
%all make in=mation describ$ 9 p>agraph 
7#a7 public ^u mak+ a det]m9ation       
describ$ 9 t p>agraph1 reg>dless ( :e!r 
a practition] has submitt$ su* an       
application at t "t4  4  #d4 ,te*nical  
correction on controll$ sub/ances       
disp5s+ ,effective z if includ$ 9 !     
enactm5t ( ,public ,law #aag-cbh-- 7#a7 

section #abeb7;a7 ( division ,,ff (     
,public ,law #aag-cbh 7#acf ,/at4 #efha7
 is am5d$1 9 ! matt] be+ ins]t$ into    
section #cjb7;e7 ( ! ,controll$         
,sub/ances ,act1 by /rik+ #cjc7;g7 &    
ins]t+ #cjc7;h72  7#b7 section #abfb (  
division ,,ff ( ,public ,law #aag-cbh   
7#acf ,/at4 #efha7 is am5d$-- 7,a7 9    
subsection 7a7-- 7i7 9 ! matt] prec$+   
p>agraph 7#a71 by /rik+ #cjc7;g7 &      
ins]t+ #cjc7;h72  7ii7 9 ! matt] be+    
/rick5 by subsection 7a77#b71 by /rik+  
7g77#a7 & ins]t+ 7h77#a72 &  7iii7 9 !  
matt] be+ ins]t$ by subsection 7a77#b71 
by /rik+ 7g7 ,practition]s & ins]t+ 7h7 
,practition]s2 &  7,b7 9 subsection     
7b7-- 7i7 9 ! matt] be+ /rick5 by       
p>agraph 7#a71 by /rik+ #cjc7;g77#a7 &  
ins]t+ #cjc7;h77#a72  7ii7 9 ! matt] be+
 ins]t$ by p>agraph 7#a71 by /rik+      
#cjc7;g7 & ins]t+ #cjc7;h72  7iii7 9 !  
matt] be+ /rick5 by p>agraph 7#b77;,a71 
by /rik+ #cjc7;g77#b7 & ins]t+          
#cjc7;h77#b72  7iv7 9 ! matt] be+ /rick5
 by p>agraph 7#c71 by /rik+             

#cjc7;g77#b77;,b7 & ins]t+              
#cjc7;h77#b77;,b72  7v7 9 ! matt] be+   
/rick5 by p>agraph 7#e71 by /rik+       
#cjc7;g7 & ins]t+ #cjc7;h72 &  7vi7 9 ! 
matt] be+ /rick5 by p>agraph 7#f71 by   
/rik+ #cjc7;g7 & ins]t+ #cjc7;h72 &     
7#c7 section #abfc7;b7 ( division ,,ff (
 ,public ,law #aag-cbh 7#acf ,/at4      
#efhe7 is am5d$-- 7,a7 by /rik+         
#cjc7;g77#b7 & ins]t+ #cjc7;h77#b72 &   
7,b7 by /rik+ 7#ba ,u4,s4,c4            
#hbc7;g77#b77 & ins]t+ 7#ba ,u4,s4,c4   
#hbc7;h77#b774  #e4 ,rulemak+  7a7      
,int]im f9al rules ,! ,attorney ,g5]al--
 7#a7 %all1 n lat] ?an #f mon?s aft] !  
date ( enactm5t ( ?is ,act1 issue rules 
to implem5t ?is ,act & ! am5dm5ts made  
by ?is ,act2 &  7#b7 may issue ! rules  
"u p>agraph 7#a7 z int]im f9al rules4   
7b7 ,proc$ure = f9al rule  7#a7         
,effectiv5ess ( int]im f9al rules ,a    
rule issu$ by ! ,attorney ,g5]al z an   
int]im f9al rule "u subsection 7a7 %all 
become imm$iately effective z an int]im 
f9al rule )\t requir+ ! ,attorney ,g5]al

 to demon/rate good cause !re=1 not)/&+ 
subp>agraph 7,b7 ( ! undesignat$ matt]  
foll[+ p>agraph 7#d7 ( section #eec7;b7 
( title #e1 ,unit$ ,/ates ,code4  7#b7  
,opportunity = comm5t & he>+ ,an int]im 
f9al rule issu$ "u subsection 7a7 %all  
give int]e/$ p]sons ! opportunity to    
comm5t & to reque/ a he>+4  7#c7 ,f9al  
rule ,aft] ! conclusion ( su* proce$+s1 
! ,attorney ,g5]al %all issue a f9al    
rule to implem5t ?is ,act & ! am5dm5ts  
made by ?is ,act 9 accordance ) section 
#eec ( title #e1 ,unit$ ,/ates ,code4   
#f4 ,p5alties  7a7 ,9 g5]al ,section    
#dja7;b77#a7 ( ! ,controll$ ,sub/ances  
,act 7#ba ,u4,s4,c4 #hda7;b77#a77 is    
am5d$-- 7#a7 9 subp>agraph 7,a77vi71 by 
ins]t+ or a f5tanyl-relat$ sub/ance aft]
 any analogue (                         
,n-ph5yl-,n-#a-7b-ph5yle?yl7-#d-pip]id9y
l propanamide2 &  7#b7 9 subp>agraph    
7,b77vi71 by ins]t+ or a f5tanyl-relat$ 
sub/ance aft] any analogue (            
,n-ph5yl-,n-#a-7b-ph5yle?yl7-#d-pip]id9y
l propanamide4  7b7 ,importation &      

exportation ,section #ajaj7;b7 ( !      
,controll$ ,sub/ances ,import & ,export 
,act 7#ba ,u4,s4,c4 #ifj7;b77 is am5d$--
 7#a7 9 p>agraph 7#a77;,f71 by ins]t+ or
 a f5tanyl-relat$ sub/ance aft] any     
analogue (                              
,n-ph5yl-,n-#a-7b-ph5yle?yl7-#d-pip]id9y
l propanamide2 &  7#b7 9 p>agraph       
7#b77;,f71 by ins]t+ or a f5tanyl-relat$
 sub/ance aft] any analogue (           
,n-ph5yl-,n-#a-7b-ph5yle?yl7-#d-pip]id9y
l propanamide4  7c7 ,def9ition (        
f5tanyl-relat$ sub/ance ,section #ajb ( 
! ,controll$ ,sub/ances ,act 7#ba       
,u4,s4,c4 #hjb7 is am5d$ by add+ at !   
end ! foll[+3  7#fj7 ,! t]m             
f5tanyl-relat$ sub/ance has ! mean+ giv5
 ! t]m 9 subsection 7e77#b7 ( s*$ule ,i 
( section #bjb7;c74  4  #g4             
,applicability2 o!r matt]s  7a7 ,9 g5]al
 ,irrespective ( ! date on :i* ! rules  
requir$ by section #e are f9aliz$1 !    
am5dm5ts made by ?is ,act apply beg9n+ z
 ( ! date ( enactm5t ( ?is ,act4  7b7   
,rule ( con/ruction ,no?+ 9 ! am5dm5ts  

made by ?is ,act may be con/ru$ z       
evid5ce t1 9 apply+ sections            
#dja7;b77#a7 ( ! ,controll$ ,sub/ances  
,act 7#ba ,u4,s4,c4 #hda7;b77#a77 &     
#ajaj7;b7 ( ! ,controll$ ,sub/ances     
,import & ,export ,act 7#ba ,u4,s4,c4   
#ifj7;b77 ) respect to conduct occurr+  
be=e ! date ( ! enactm5t ( ?is ,act1 a  
f5tanyl-relat$ sub/ance 7z def9$ by su* 
am5dm5ts7 is n an analogue (            
,n-ph5yl-,n-#a-7b-ph5yle?yl7-#d-pip]id9y
l propanamide4  7c7 ,s5se ( ,congress   
,congress agrees ) ! int]pretation ( !  
,controll$ ,sub/ances ,act 7#ba         
,u4,s4,c4 #hja et seq47 9 ,unit$ ,/ates 
v4 ,mc,cray1 #cdf ,f4 ,supp4 #c;d #cfc  
7,w4,d4,n4,y4 #bjah74  ,m>* #c1         
#bjbe,report$ ) an am5dm5t