,,ii  #aag? ,,congress  #b;d ,session   
,s4 #eabc  ,,9 ,,! ,,s5ate ,,( ,,!      
,,unit$ ,,/ates  ,novemb] #ag1 #bjbb,mr4
 ,book] 7= himself & ,mr4 ,paul7        
introduc$ ! foll[+ bill2 :i* 0 read     
twice & ref]r$ to ! ,committee on !     
,judici>y  ,a ,,bill  ,to am5d !        
,controll$ ,sub/ances ,act to modify !  
regi/ration requirem5ts relat+ to       
rese>*1 & = o!r purposes4  #a4 ,%ort    
title ,?is ,act may be cit$ z !         
,break?r\gh ,!rapies ,act4  #b4         
,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$ by add+ at !   
end ! foll[+ new subsection3  7l7       
,special provisions = ^? conduct+ c]ta9 
rese>* ) s*$ule i controll$ sub/ances   
7#a7 ,9 g5]al ,not)/&+ subsection 7f71 a
 practition] may conduct rese>* t is    
describ$ by p>agraph 7#b7 & t is ) #a or
 m s*$ule ,i sub/ances if "o ( ! foll[+ 
conditions is satisfi$3 7,a7 ,rese>*] ) 

a curr5t s*$ule ,i or ,,ii rese>*       
regi/ration ,if ! practition] is regi/]$
 to conduct rese>* ) a controll$        
sub/ance 9 s*$ule ,i or ,,ii1 !         
practition] may conduct rese>* "u ?is   
p>agraph #cj days aft] ! practition] has
 s5t a notice to ! ,attorney ,g5]al     
conta9+ ! foll[+ in=mation1 ) respect to
 ea* sub/ance ) :i* ! rese>* w be       
conduct$3 7i7 ,! *emical "n ( !         
sub/ance4  7ii7 ,! quantity ( ! sub/ance
 to be us$ 9 su* rese>*4  7iii7         
,demon/ration t ! rese>* is 9 ! category
 describ$ by p>agraph 7#b71 :i*         
demon/ration c be satisfi$-- 7,i7 9 !   
case ( a grant1 contract1 coop]ative    
agreem5t1 or o!r transaction1 or        
intramural rese>* project1 by id5tify+ !
 sponsor+ ag5cy & supply+ in=mation     
relat$ to ! grant1 contract1 coop]ative 
agreem5t1 o!r transaction1 or project2  
or  7,,ii7 9 ! case ( an application "u 
section #eje7;i7 ( ! ,f$]al ,food1      
,drug1 & ,cosmetic ,act1 by supply+ !   
application numb] & ! sponsor ( record  

on su* application4  7iv7 ,demon/ration 
t ! rese>*] is au?oriz$ to conduct      
rese>* ) respect to ! sub/ance "u ! laws
 ( ! ,/ate 9 :i* ! rese>* w take place4 
7,b7 ,rese>*] )\t a curr5t s*$ule ,i or 
,,ii  7i7 ,rese>* regi/ration ,if !     
practition] is n curr5tly regi/]$ 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,a71 )  
respect to ea* sub/ance ) :i* ! rese>* w
 be conduct$1 & ! ,attorney ,g5]al w    
treat su* notice z a suffici5t          
application = a rese>* regi/ration4 ,n  
lat] ?an #de days ( receiv+ su* a notice
 t conta9s all in=mation requir$ by     
subp>agraph 7,a71 ! ,attorney ,g5]al    
%all regi/] ! applicant1 or s]ve an ord]
 to %[ cause ^u ! applicant 9 accordance
 ) section #hbd7;c7 ( ?is title4  7,c7  
,v]ification ( in=mation ,on reque/ f ! 
,attorney ,g5]al1 ! ,secret>y ( ,heal? &
 ,human ,s]vices or ! ,secret>y (       
,vet]ans ,affairs1 z appropriate1 %all  

v]ify in=mation submitt$ by an applicant
 "u subp>agraph 7,a77iii74  7#b7 ,rese>*
 subject to exp$it$ proc$ure ,rese>* is 
describ$ by ?is p>agraph if-- 7,a7 !    
rese>* is ! subject ( an application "u 
section #eje7;i7 ( ! ,f$]al ,food1      
,drug1 & ,cosmetic ,act = ! inve/igation
 ( a drug :i* is 9 effect 9 accordance )
 section #cab4dj ( title #ba1 ,code (   
,f$]al ,regulations2 or  7,b7 ! rese>*  
is conduct$ by ! ,dep>tm5t ( ,heal? &   
,human ,s]vices or ! ,dep>tm5t (        
,vet]ans ,affairs or is 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 ( ,vet]ans ,affairs1
 or a ,/ate heal? dep>tm5t4  7#c7       
,electronic submissions ,! ,attorney    
,g5]al %all provide a means to p]mit    
practition]s to submit notifications "u 
p>agraph 7#a7 electronically4  7#d7     
,limitation on am\nts ,a practition]    
conduct+ rese>* ) a s*$ule ,i sub/ance  
pursuant to ?is subsection %all only be 

p]mitt$ to possess ! am\nts ( s*$ule ,i 
sub/ance id5tifi$ 9-- 7,a7 !            
notification to ! ,attorney ,g5]al "u   
p>agraph 7#a72 or  7,b7 a supplem5tal   
notification t ! practition] may s5d if 
! practition] ne$s additional am\nts = !
 rese>*1 :i* supplem5tal notification   
%all include ! regi/rant's "n1 !        
additional quantity ne$$ ( ! sub/ance1 &
 an atte/ation t ! rese>* to be conduct$
 ) ! sub/ance is consi/5t ) ! scope ( ! 
rese>* t 0 ! subject ( ! notification "u
 p>agraph 7#a74  7#e7 ,importation &    
exportation requirem5ts n affect$ ,no?+ 
9 ?is section alt]s ! requirem5ts ( "p  
,a ( title ,,iii1 reg>d+ ! importation &
 exportation ( controll$ sub/ances4  4  
7b7 ,sep>ate regi/rations n requir$ =   
additional rese>*] 9 same in/itution    
,section #cjb ( ! ,controll$ ,sub/ances 
,act 7#ba ,u4,s4,c4 #hbb7 is am5d$ 9    
subsection 7c71 by add+ ! foll[+        
p>agraph3  7#d7 ,an ag5t or employee ( a
 rese>* in/itution t is conduct+ rese>* 
) a controll$ sub/ance if-- 7,a7 su*    

ag5t or employee is act+ )9 ! scope ( 8 
or h] pr(essional practice2  7,b7 ano!r 
ag5t or employee ( su* 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/]$2     
7ii7 au?orizes su* ag5t or employee to  
p]=m rese>* "u ! regi/]$ rese>*]'s      
regi/ration2 &  7iii7 affirms t all acts
 tak5 by su* ag5t or employee involv+   
controll$ sub/ances %all be attributable
 to ! regi/]$ rese>*]1 z if ! rese>*] _h
 directly committ$ su* acts1 = purposes 
( any proce$+ "u section #cjd7;a7 7#ba  
,u4,s4,c4 #hbd7;a77 to susp5d or revoke 
! regi/ration ( ! regi/]$ 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;a7 7#ba ,u4,s4,c4  
#hbd7;a771 to all[ su* ag5t or employee 

to possess su* sub/ance )\t a sep>ate   
regi/ration4  4  7c7 ,s+le regi/ration =
 relat$ rese>* sites ,su* section #cjb  
is fur!r am5d$ 9 subsection 7e7 by add+ 
at ! end ! foll[+ new p>agraph3  7#c7   
7,a7 ,not)/&+ p>agraph 7#a71 a p]son    
regi/]$ to conduct rese>* ) a controll$ 
sub/ance "u section #cjc7;f7 may conduct
 su* rese>* "u a s+le regi/ration if--  
7i7 su* rese>* occurs exclusively on    
sites all ( :i* are )9 ! same city or   
c\nty & are "u ! control ( ! same       
in/itution1 organization1 or ag5cy2 &   
7ii7 ! rese>*] notifies ! ,attorney     
,g5]al ( all sites :]e ! rese>* w be    
conduct$ or :]e ! controll$ sub/ance w  
be /or$ or adm9i/]$ prior to comm5c+ su*
 rese>*4  7,b7 ,a site describ$ by      
subp>agraph 7,a7 %all be includ$ 9 su*  
regi/ration only if ! rese>*] has       
notifi$ ! ,attorney ,g5]al ( su* site-- 
7i7 9 ! application = su* regi/ration2  
or  7ii7 be=e ! rese>* is conduct$1 or  
be=e ! controll$ sub/ance is /or$ or    
adm9i/]$1 at su* site4  7,c7 ,!         

,attorney ,g5]al may1 9 consultation ) !
 ,secret>y ( ,heal? & ,human ,s]vices1  
issue regulations address+-- 7i7 ! mann]
 9 :i* controll$ sub/ances may be       
deliv]$ to ! rese>* sites describ$ 9    
subp>agraph 7,a72  7ii7 ! /orage &      
security ( controll$ sub/ances at su*   
rese>* sites2  7iii7 ! ma9t5ance (      
records = su* rese>* sites2 &  7iv7 any 
o!r matt]s necess>y to ensure effective 
controls aga9/ div]sion at su* rese>*   
sites4  4  7d7 ,new inspection n requir$
 9 c]ta9 situations ,su* section #cjb is
 fur!r am5d$ 9 subsection 7f7-- 7#a7 by 
/rik+ 7f7 ,! & ins]t+ 7f77#a7 ,!2 &     
7#b7 by add+ a new p>agraph1 z foll[s3  
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$4  7,b7    
,no?+ 9 ?is p>agraph %all prohibit !    
,attorney ,g5]al f conduct+ any         
inspection if ! ,attorney ,g5]al deems x
 necess>y to ensure t ! regi/rant       
ma9ta9s effective controls aga9/        
div]sion4  4  7e7 ,cont9uation ( rese>* 
on sub/ances newly add$ to s*$ule i ,su*
 section #cjb is fur!r am5d$ by add+ at 
! end ! foll[+ new subsection3  7h7     
,cont9uation ( rese>* on sub/ances newly
 add$ to s*$ule ,i ,if a p]son is       
conduct+ rese>* on a sub/ance at ! "t ! 
sub/ance is add$ to s*$ule ,i1 & su*    
p]son is already regi/]$ to conduct     
rese>* ) a controll$ sub/ance 9 s*$ule  
,i1 !n-- 7#a7 ! p]son %all1 n lat] ?an  
#ij days ( ! s*$ul+ ( ! newly s*$ul$    
sub/ance1 submit a complet$ application 
= regi/ration or modification ( exi/+   
regi/ration1 to conduct rese>* on su*   
sub/ance1 9 accordance ) ! regulations  
issu$ by ! ,attorney ,g5]al2  7#b7 !    
p]son may1 not)/&+ subsections 7a7 &    

7b71 cont9ue to conduct ! rese>* on su* 
sub/ance until ! p]son )draws su*       
application or until ! ,attorney ,g5]al 
s]ves on ! p]son an ord] to %[ cause    
propos+ ! d5ial ( ! application pursuant
 to section #cjd7;c72  7#c7 if !        
,attorney ,g5]al s]ves su* an ord] to %[
 cause & ! p]son reque/s a he>+1 su*    
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 
ref]r$ to 9 t p>agraph to a manufactur] 
or di/ributor ( su* sub/ance1 receipt ( 
su* copy by su* manufactur] or          
di/ributor %all con/itute suffici5t     
evid5ce t ! p]son is au?oriz$ to receive
 su* sub/ance4  4  7f7 ,treatm5t ( c]ta9
 manufactur+ activities z co9cid5t to   
rese>* ,su* section #cjb 7#ba ,u4,s4,c4 
#hbb7 is fur!r am5d$ by add+ at ! end ! 
foll[+ new subsection3  7j7 ,treatm5t ( 
c]ta9 manufactur+ activities z co9cid5t 
to rese>*  7#a7 ,9 g5]al ,except z      

specifi$ 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 li/$ 9 p>agraph 7#b71
 )\t be+ requir$ to obta9 a manufactur+ 
regi/ration1 if su* activities are p]=m$
 = ! purpose ( ! rese>* & if !          
activities & ! quantities ( ! sub/ance  
involv$ 9 ^? activities are /at$ 9--    
7,a7 a notification submitt$ to !       
,attorney ,g5]al "u section #cjc7l72    
7,b7 a protocol fil$ ) an application = 
regi/ration approval1 "u section        
#cjc7;f72 or  7,c7 a notification to !  
,attorney ,g5]al t includes !           
regi/rant's "n & 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 ! in=mation provid$ z 
"p ( a notification submitt$ to !       
,attorney ,g5]al "u section #cjc7l7 7#ba
 ,u4,s4,c4 #hbc7l77 or a rese>* protocol
 fil$ ) ! application = regi/ration     
approval2 &  7,b7 dosage =m developm5t  
/udies p]=m$ = ! purpose ( satisfy+     
,,fda regulatory requirem5ts = submitt+ 
an inve/igational new drug application4 
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$ures ,section #cjc ( su*  
,act 7#ba ,u4,s4,c4 #hbc7 is fur!r am5d$
 by add+ at ! end ! foll[+ new          
subsection3  7m7 ,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>* ) su*
 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>* ) su*    
sub/ances2 &  7,c7 h[ su* process &     
crit]ia diff] f ^? applicable to        
applications to conduct rese>* ) o!r    
controll$ sub/ances 9 ! same s*$ule4    
7#b7 ,tim+ ( po/+ ,! ,attorney ,g5]al   
%all make su* in=mation public ^u mak+  
su* det]m9ation1 reg>dless ( :e!r a     
practition] has submitt$ su* an         
application at t "t4  4  #c4 ,curr5tly  
accept$ m$ical use ) sev]e re/rictions  
7a7 ,def9itions ,section #ajb ( !       
,controll$ ,sub/ances ,act 7#ba         
,u4,s4,c4 #hjb7 is am5d$ by ins]t+ aft] 
p>agraph 7#g7 ! foll[+3  7#g7 7,a7      
,subject to subp>agraph 7,b71 ! t]m     
curr5tly accept$ m$ical use ) sev]e     
re/rictions1 ) respect to a drug or o!r 

sub/ance1 includes a drug or o!r        
sub/ance t is an active moiety or active
 +r$i5t 7:e!r 9 natural or syn!tic =m7 (
 an inve/igational new drug = :i* a     
waiv] is 9 effect "u section #eje7;i7 ( 
! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 
7#ba ,u4,s4,c4 #cee7;i77 or section     
#cea7;a77#c7 ( ! ,public ,heal? ,s]vice 
,act 7#db ,u4,s4,c4 #bfb7;a77#c77 & t ! 
,secret>y-- 7i7 designates z a          
break?r\gh !rapy "u section #ejf7;a7 ( !
 ,f$]al ,food1 ,drug1 & ,cosmetic ,act  
7#ba ,u4,s4,c4 #cef7;a772 or  7ii7      
au?orizes = exp&$ access "u subsection  
7b7 or 7c7 ( section #efa ( ! ,f$]al    
,food1 ,drug1 & ,cosmetic ,act 7#ba     
,u4,s4,c4 #cfj;bbb71 ei!r alone or z "p 
( a !rapeutic protocol1 to treat pati5ts
 ) s]i\s or life-?reat5+ diseases = :i* 
no comp>able or satisfactory !rapies are
 available4  7,b7 ,a drug or o!r        
sub/ance %all n meet ! crit]ia "u       
subp>agraph 7,a7 = hav+ a curr5tly      
accept$ m$ical use ) sev]e re/rictions  
if-- 7i7 9 ! case ( a drug or o!r       

sub/ance describ$ 9 subp>agraph         
7,a77ii7-- 7,i7 ! ,secret>y places !    
exp&$ access or protocol = su* drug on  
cl9ical hold z describ$ 9 section       
#cab4db ( title #ba1 ,code ( ,f$]al     
,regulations 7or any successor          
regulations72  7,,ii7 !re is no o!r     
inve/igational new drug conta9+ ! drug  
or o!r sub/ance = :i* exp&$ access has  
be5 au?oriz$ "u section #efa7;a7 ( !    
,f$]al ,food1 ,drug1 & ,cosmetic ,act   
7#ba ,u4,s4,c4 #cfj;bbb7a772 &  7,,iii7 
! drug or o!r sub/ance does n meet !    
requirem5ts ( subp>agraph 7,a77i72 or   
7ii7 ! drug or o!r sub/ance is an active
 moiety or active +r$i5t 7:e!r natural  
or syn!tic7 ( an application approv$ "u 
section #eje ( ! ,f$]al ,food1 ,drug1 & 
,cosmetic ,act 7#ba ,u4,s4,c4 #cee7 or  
section #cea ( ! ,public ,heal? ,s]vice 
,act 7#db ,u4,s4,c4 #bfb74  4  7b7      
,au?ority & crit]ia = classification (  
sub/ances ,section #bja7;j7 ( !         
,controll$ ,sub/ances ,act 7#ba         
,u4,s4,c4 #haa7;j77 is am5d$-- 7#a7 9   

p>agraph 7#a71 by ins]t+ a drug         
designat$ z a break?r\gh !rapy "u       
section #ejf7;a7 ( ! ,f$]al ,food1      
,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4  
#cef7;a771 or a drug au?oriz$ = exp&$   
access "u subsection 7b7 or 7c7 (       
section #efa ( ! ,f$]al ,food1 ,drug1 & 
,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;bbb7 
aft] subsection 7f712 &  7#b7 9 p>agraph
 7#b7-- 7,a7 9 subp>agraph 7,a71 by     
/rik+ 2 or & ins]t+ a semicolon2  7,b7 9
 subp>agraph 7,b71 by /rik+ ! p]iod at !
 end & ins]t+ a semicolon2 &  7,c7 by   
add+ at ! end ! foll[+3  7,c7 ! date on 
:i* ! ,attorney ,g5]al receives         
notification f ! ,secret>y ( ,heal? &   
,human ,s]vices t ! ,secret>y has       
designat$ a drug z a break?r\gh !rapy "u
 section #ejf7;a7 ( ! ,f$]al ,food1     
,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4  
#cef7;a77 or au?oriz$ a drug = exp&$    
access "u subsection 7b7 or 7c7 (       
section #efa ( ! ,f$]al ,food1 ,drug1 & 
,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;bbb72
 or  7,d7 ! date on :i* ! ,attorney     

,g5]al receives any writt5 notification 
demon/rat+ t ! ,secret>y1 be=e ! date ( 
enactm5t ( ?is subp>agraph1 designat$ a 
drug z a break?r\gh !rapy "u section    
#ejf7;a7 ( ! ,f$]al ,food1 ,drug1 &     
,cosmetic ,act 7#ba ,u4,s4,c4 #cef7;a77 
or au?oriz$ a drug = exp&$ access "u    
subsection 7b7 or 7c7 ( section #efa ( !
 ,f$]al ,food1 ,drug1 & ,cosmetic ,act  
7#ba ,u4,s4,c4 #cfj;bbb74  4