,i  #aad? ,,congress  #b;d ,session  ,h4
 ,r4 #eabg  ,,9 ,,! ,,h\se ,,(          
,,repres5tatives  ,april #bi1 #bjaf ,mr4
 ,griffi? 7= himself1 ,mr4 ,connolly1 & 
,mr4 ,bilirakis7 introduc$ ! foll[+     
bill2 :i* 0 ref]r$ to ! ,committee on   
,en]gy & ,comm]ce  ,a ,,bill  ,to am5d !
 ,f$]al ,food1 ,drug1 & ,cosmetic ,act  
to ext5d ! exclusivity p]iod = c]ta9    
drug products develop$ or label$ s z to 
r$uce drug abuse1 & = o!r purposes4  #a4
 ,%ort title ,?is ,act may be cit$ z !  
,curb ,opioid ,misuse ,by ,advanc+      
,te*nology ,act ( #bjaf 4  #b4 ,ext5d$  
exclusivity = c]ta9 drug products to    
protect ! public heal?  7a7 ,new drug   
applications ,section #eje7;c77#c77;,e7 
( ! ,f$]al ,food1 ,drug1 & ,cosmetic    
,act 7#ba ,u4,s4,c4 #cee7;c77#c77;,e77  
is am5d$ by add+ at ! end ! foll[+3     
7vi7 ,) respect to an application       
describ$ 9 clause 7iii7 or a supplem5t  
to an application describ$ 9 clause     
7iv71 if su* application or supplem5t is
 approv$ on or aft] ! date ( enactm5t ( 

! ,curb ,opioid ,misuse ,by ,advanc+    
,te*nology ,act ( #bjaf1 ! #c-ye> p]iod 
specifi$ 9 ea* su* clause %all be ext5d$
 = an additional p]iod ( #ab mon?s if ! 
p]son submitt+ su* application or       
supplem5t provides docum5tation to !    
,secret>y demon/rat+ t ! drug t is !    
subject ( ! application or supplem5t--  
7,i7 is approv$1 9 :ole or 9 "p1 on !   
basis ( "o or m new cl9ical abuse       
pot5tial /udies2 &  7,,ii7 is approv$ ) 
label+ t *>act]izes ! abuse-det]r5t     
prop]ties ( ! drug product4  4  7b7     
,abbreviat$ new drug applications       
,section #eje7;j77#e7 ( ! ,f$]al ,food1 
,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4  
#cee7;j77#e77 is am5d$--  7#a7 9        
subp>agraph 7,b71 by add+ at ! end !    
foll[+3  7v7 ,) respect to an abbreviat$
 application describ$ 9 clause 7iv71 if 
su* application is approv$ on or aft] ! 
date ( enactm5t ( ! ,curb ,opioid       
,misuse ,by ,advanc+ ,te*nology ,act (  
#bjaf1 ! #ahj-;day p]iod specifi$ 9 su* 
clause %all be ext5d$ = an additional   

p]iod ( #fj days if ! fir/ applicant    
submitt+ ! abbreviat$ application       
provides docum5tation to ! ,secret>y    
demon/rat+ t ! li/$ drug ref]r$ to      
p>agraph 7#b77;,a77i7 & ref]5c$ 9 !     
abbreviat$ application--  7,i7 is       
approv$1 9 :ole or 9 "p1 on ! basis ( "o
 or m new cl9ical abuse pot5tial /udies2
 &  7,,ii7 is approv$ ) label+ t        
*>act]izes ! abuse-det]r5t prop]ties ( !
 drug product4  2 &  7#b7 9 subp>agraph 
7,f71 by add+ at ! end ! foll[+3  7vi7  
,) respect to an application describ$ 9 
clause 7iii7 or a supplem5t to an       
application describ$ 9 clause 7iv71 if  
su* application or supplem5t is approv$ 
on or aft] ! date ( enactm5t ( ! ,curb  
,opioid ,misuse ,by ,advanc+ ,te*nology 
,act ( #bjaf1 ! #c-ye> p]iod specifi$ 9 
ea* su* clause %all be ext5d$ = an      
additional p]iod ( #ab mon?s if ! p]son 
submitt+ su* application or supplem5t   
provides docum5tation to ! ,secret>y    
demon/rat+ t ! drug t is ! subject ( !  
application or supplem5t--  7,i7 is     

approv$1 9 :ole or 9 "p1 on ! basis ( "o
 or m new cl9ical abuse pot5tial /udies2
 &  7,,ii7 is approv$ ) label+ t        
*>act]izes ! abuse-det]r5t prop]ties ( t
 drug product4  4  7c7 ,regulations     
7#a7 ,9 g5]al ,n lat] ?an #b ye>s aft] !
 date ( ! enactm5t ( ?is ,act1 !        
,secret>y ( ,heal? & ,human ,s]vices    
7ref]r$ to 9 ?is section z ! ,secret>y7 
%all adopt f9al regulations1 :i* %all h 
be5 promulgat$ 9 accordance ) section   
#eec ( title #e1 ,unit$ ,/ates ,code1 to
 c>ry out ! am5dm5ts made by ?is        
section4  7#b7 ,re/rictions ,not)/&+ any
 o!r provision ( law1 ! ,secret>y %all  
promulgate regulations implem5t+ ?is    
section only z describ$ 9 p>agraph 7#a71
 except t ! ,secret>y may issue int]im  
guidance = p]sons claim+ eligibility = !
 ext5sion provid$ by clause 7vi7 (      
subsection 7c77#c77;,e7 or 7j77#e77;,f7 
( section #eje ( ! ,f$]al ,food1 ,drug1 
& ,cosmetic ,act 7z add$ by subsections 
7a7 & 7b77 prior to ! promulgation ( su*
 regulations4  7#c7 ,exclusivity prior  

to regulations ,! ,secret>y %all aw>d ! 
ext5sions provid$ by clause 7vi7 (      
subsection 7c77#c77;,e7 or 7j77#e77;,f7 
& by clause 7v7 ( subsection            
7j77#e77;,b7 ( section #eje ( ! ,f$]al  
,food1 ,drug1 & ,cosmetic ,act 7z add$  
by subsections 7a7 & 7b77 prior to !    
promulgation ( regulations "u ?is       
subsection1 if an application1          
supplem5t1 or abbreviat$ application    
meets ! requirem5ts = ! applicable      
ext5sion4  7d7 ,def9itions  7#a7 ,! t]m 
new cl9ical inve/igations 9 subsections 
7c77#c77;,e77iii71 7c77#c77;,e77iv71    
7j77#e77;,f77iii71 & 7j77#e77;,f77iv7 ( 
section #eje ( ! ,f$]al ,food1 ,drug1 & 
,cosmetic ,act 7#ba ,u4,s4,c4 #cee7 %all
 include new cl9ical abuse pot5tial     
/udies int5d$ to assess ! impact (      
pot5tially abuse-det]r5t prop]ties (    
drug products 9 human subjects4  7#b7 ,!
 t]ms conditions ( approval & *ange     
approv$ 9 ! supplem5t 9 subsections     
7c77#c77;,e77iii7 & 7c77#c77;,e77iv7 (  
section #eje ( ! ,f$]al ,food1 ,drug1 & 

,cosmetic ,act 7#ba ,u4,s4,c4 #cee7 %all
 include any abuse-det]r5t prop]ties ( a
 drug product subject to ! ext5sion     
provid$ by subsection 7c77#c77;,e77vi7 (
 su* section #eje 7z add$ by subsection 
7a771 su* t ! ,secret>y may n make !    
approval ( an application submitt$ "u   
subsection 7b77#b7 ( su* section #eje   
effective be=e ! expiration ( #d ye>s f 
! date ( ! approval ( ! application or  
supplem5t "u subsection 7b7 ( su*       
section #eje1 includ+ ! ext5sion "u     
subsection 7c77#c77;,e77vi7 ( su*       
section #eje1 unless ! application      
submitt$ "u subsection 7b77#b7 ( su*    
section #eje--  7,a7 is approv$1 9 :ole 
or 9 "p1 on ! basis ( "o or m new       
cl9ical abuse pot5tial /udies2 &  7,b7  
is approv$ ) label+ t *>act]izes !      
abuse-det]r5t prop]ties ( ! drug        
product4  7#c7 ,! t]ms conditions (     
approval & *ange approv$ 9 ! supplem5t 9
 subsections 7j77#e77;,f77iii7 &        
7j77#e77;,f77iv7 ( section #eje ( !     
,f$]al ,food1 ,drug1 & ,cosmetic ,act   

7#ba ,u4,s4,c4 #cee7 %all include any   
abuse-det]r5t prop]ties ( a drug product
 subject to ! ext5sion provid$ by       
subsection 7j77#e77;,f77vi7 ( su*       
section #eje 7z add$ by subsection 7b771
 su* t ! ,secret>y may n make ! approval
 ( an abbreviat$ application = a drug   
product submitt$ "u subsection 7j7 ( su*
 section #eje effective be=e !          
expiration ( #d ye>s f ! date ( !       
approval ( ! application or supplem5t "u
 subsection 7b7 ( su* section #eje1     
includ+ ! ext5sion "u subsection        
7j77#e77;,f77vi7 ( su* section #eje4    
7e7 ,relation to o!r exclusivity p]iods 
,any ext5sion "u clause 7vi7 9          
subsection 7c77#c77;,e7 or 7j77#e77;,f7 
( section #eje ( ! ,f$]al ,food1 ,drug1 
& ,cosmetic ,act 7#ba ,u4,s4,c4 #cee7 7z
 add$ by subsections 7a7 & 7b77 %all be 
9 addition to any ext5sions "u section  
#eje;,a or #eje;,e ( ! ,f$]al ,food1    
,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4  
#cee;a2 #ba ,u4,s4,c4 #cee;f7 ) respect 
to ! drug4