,i  #aae? ,,congress  #a/ ,session  ,h4 
,r4 #bjbe  ,,9 ,,! ,,h\se ,,(           
,,repres5tatives  ,april #f1 #bjag ,mr4 
,griffi? 7= himself & ,mr4 ,co/ello (   
,p5nsylvania7 introduc$ ! foll[+ bill2  
:i* 0 ref]r$ to ! ,committee on ,en]gy &
 ,comm]ce  ,a ,,bill  ,to am5d section  
#eje7;c77#c77;,e7 ( ! ,f$]al ,food1     
,drug1 & ,cosmetic ,act to prev5t c]ta9 
applications f be+ consid]$ ineligible =
 approval "u section #eje7;c7 ( su* ,act
 on ! basis t ! propos$ label+ includes 
in=mation describ+ abuse-det]r5t        
prop]ties t o!rwise w\ld be block$ by   
exclusivity "u clause 7iii7 or 7iv7 (   
section #ejc7;c77#c77;,e7 ( su* ,act1 & 
= o!r purposes4  #a4 ,%ort title ,?is   
,act may be cit$ z ! ,abuse-,det]r5t    
,opioids ,plan = ,tomorr[ ,act ( #bjag4 
#b4 ,label+ in=mation describ+          
abuse-det]r5t prop]ties  7a7 ,9 g5]al   
,subp>agraph 7,e7 ( section #eje7;c77#c7
 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic   
,act 7#ba ,u4,s4,c4 #cee7;c77#c77 is    
am5d$ by add+ at ! end ! foll[+ new     

clause3  7vi7 ,a drug = :i* an          
application 7or a supplem5t to an       
application7 describ$ 9 subsection      
7b77#b7 is submitt$ %all n be consid]$  
ineligible = approval "u ?is subsection 
on ! basis t its label+ includes        
in=mation describ+ ! abuse-det]r5t      
prop]ties ( ! drug 7includ+             
abuse-det]r5t claims7 t o!rwise w\ld be 
block$ by exclusivity "u clause 7iii7 or
 7iv7 ( ?is subp>agraph if-- 7,i7 !     
inve/igation or inve/igations reli$ ^u  
by ! applicant = approval ( ! label+    
in=mation 7 conduct$ by or = ! applicant
 or ! applicant has obta9$ a "r (       
ref]5ce or use f ! p]son by or = :om !  
inve/igation or inve/igations 7         
conduct$2 &  7,,ii7 ! drug has mean+ful 
te*nological diff]5ces comp>$ to ! drug 
o!rwise protect$ by exclusivity "u      
clause 7iii7 or 7iv7 ( ?is subp>agraph4 
4  7b7 ,guidance ,! ,secret>y ( ,heal? &
 ,human ,s]vices %all--  7#a7 n lat] ?an
 #ah mon?s aft] ! date ( enactm5t ( ?is 
,act1 issue draft guidance reg>d+ ! aw>d

 & scope ( exclusivity "u clauses 7iii7 
& 7iv7 ( section #eje7;c77#c77;,e7 ( !  
,f$]al ,food1 ,drug1 & ,cosmetic ,act   
7#ba ,u4,s4,c4 #cee7;c77#c77;,e77 =     
drugs ) prop]ties design$ to det] abuse 
& ! exception to su* exclusivity        
describ$ 9 clause 7vi7 ( su* section    
#eje7;c77#c77;,e71 z add$ by subsection 
7a72 &  7#b7 n lat] ?an #ah mon?s aft] !
 close ( ! p]iod = receiv+ public       
comm5ts on su* draft guidance1 publi%   
f9al guidance on ! topics describ$ 9    
p>agraph 7#a74  7c7 ,effective date ,!  
am5dm5t made by subsection 7a7 applies )
 respect to applications1 & supplem5ts  
to applications1 t are submitt$ or p5d+ 
"u section #eje7;b7 ( ! ,f$]al ,food1   
,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4  
#cee7;b77 on or aft] ,janu>y #a1 #bjag4