,,ii  #aadth ,,congress  #ast ,session  
,s4 #adba  ,,in ,,the ,,senate ,,of     
,,the ,,united ,,states  ,may #ba1      
#bjae,mr4 ,hatch 7for himself and ,ms4  
,klobuchar7 introduced the following    
bill2 which was read twice and referred 
to the ,committee on ,health1           
,education1 ,labor1 and ,pensions  ,a   
,,bill  ,to amend the ,federal ,food1   
,drug1 and ,cosmetic ,act to authorize a
 #f-month extension of certain          
exclusivity periods in the case of      
approved drugs that are subsequently    
approved for a new indication to        
prevent1 diagnose1 or treat a rare      
disease or condition1 and for other     
purposes4  #a4 ,short title ,this ,act  
may be cited as the ,orphan ,product    
,extensions ,now ,accelerating ,cures   
and ,treatments ,act of #bjae4  #b4     
,extension of exclusivity periods for a 
drug approved for a new indication for a
 rare disease or condition  7a7 ,in     
general ,chapter ,v of the ,federal     
,food1 ,drug1 and ,cosmetic ,act is     

amended by inserting after section      
#eje;,e the following3  #eje;,f4        
,extension of exclusivity periods for a 
drug approved for a new indication for a
 rare disease or condition  7a7         
,designation  7#a7 ,in general ,the     
,secretary shall designate a drug as a  
drug approved for a new indication to   
prevent1 diagnose1 or treat a rare      
disease or condition for purposes of    
granting the extensions under subsection
 7b7 if--  7,a7 prior to approval of an 
application or supplemental application 
for the new indication1 the drug was    
approved or licensed for marketing under
 section #eje7;c7 of this ,act or       
section #cea7;a7 of the ,public ,health 
,service ,act1 but was not so approved  
or licensed for the new indication2     
7,b7  7i7 the sponsor of the approved or
 licensed drug files an application or a
 supplemental application for approval  
of the new indication for use of the    
drug to prevent1 diagnose1 or treat the 
rare disease or condition2 and  7ii7 the

 ,secretary approves the application or 
supplemental application2 and  7,c7 the 
application or supplemental application 
for the new indication contains the     
consent of the applicant to notice being
 given by the ,secretary under paragraph
 7#d7 respecting the designation of the 
drug4  7#b7 ,revocation of designation  
7,a7 ,in general ,except as provided in 
subparagraph 7,b71 a designation under  
this subsection shall not be revoked for
 any reason4  7,b7 ,exception ,the      
,secretary may revoke a designation of a
 drug under paragraph 7#a7 if the       
,secretary finds that the application or
 supplemental application resulting in  
such designation contained an untrue    
statement of material fact4  7#c7       
,notification prior to discontinuance of
 production for solely commercial       
reasons ,a designation of a drug under  
paragraph 7#a7 shall be subject to the  
condition that the sponsor of the drug  
will notify the ,secretary of any       
discontinuance of the production of the 

drug for solely commercial reasons at   
least one year before such              
discontinuance4  7#d7 ,notice to public 
,notice respecting the designation of a 
drug under paragraph 7#a7 shall be made 
available to the public4  7b7 ,extension
 ,if the ,secretary designates a drug as
 a drug approved for a new indication   
for a rare disease or condition1 as     
described in subsection 7a77#a7--  7#a7 
7,a7 the #d-1 #e-1 and #g-year periods  
described in subsections                
7c77#c77;,e77ii7 and 7j77#e77;,f77ii7 of
 section #eje1 the #c-year periods      
described in clauses 7iii7 and 7iv7 of  
subsection 7c77#c77;,e7 and clauses     
7iii7 and 7iv7 of subsection            
7j77#e77;,f7 of section #eje1 and the   
#g-year period described in section     
#ebg1 as applicable1 shall be extended  
by #f months2 or  7,b7 the #d- and      
#ab-year periods described in           
subparagraphs 7,a7 and 7,b7 of section  
#cea7k77#g7 of the ,public ,health      
,service ,act and the #g-year period    

described in section #ebg1 as           
applicable1 shall be extended by #f     
months2 and  7#b7  7,a7 if the drug is  
the subject of a listed patent for which
 a certification has been submitted     
under subsection 7b77#b77;,a77ii7 or    
7j77#b77;,a77vii77,,ii7 of section #eje 
or a listed patent for which a          
certification has been submitted under  
subsections 7b77#b77;,a77iii7 or        
7j77#b77;,a77vii77,,iii7 of section     
#eje1 the period during which an        
application may not be approved under   
section #eje7;c77#c7 or section         
#eje7;j77#e77;,b7 shall be extended by a
 period of #f months after the date the 
patent expires 7including any patent    
extensions72 or  7,b7 if the drug is the
 subject of a listed patent for which a 
certification has been submitted under  
subsection 7b77#b77;,a77iv7 or          
7j77#b77;,a77vii77,,iv7 of section #eje1
 and in the patent infringement         
litigation resulting from the           
certification the court determines that 

the patent is valid and would be        
infringed1 the period during which an   
application may not be approved under   
section #eje7;c77#c7 or section         
#eje7;j77#e77;,b7 shall be extended by a
 period of #f months after the date the 
patent expires 7including any patent    
extensions74  7c7 ,relation to pediatric
 and qualified infectious disease       
product exclusivity ,any extension under
 subsection 7b7 of a period shall be in 
addition to any extension of the periods
 under sections #eje;,a and #eje;,e of  
this ,act and section #cea7m7 of the    
,public ,health ,service ,act1 as       
applicable1 with respect to the drug4   
7d7 ,limitations ,the extension         
described in subsection 7b7 shall not   
apply if the drug designated under      
subsection 7a77#a7 has previously       
received an extension by operation of   
subsection 7b74  7e7 ,definition ,in    
this section1 the term rare disease or  
condition has the meaning given to such 
term in section #ebf7;a77#b74  4  7b7   

,application ,section #eje;,f of the    
,federal ,food1 ,drug1 and ,cosmetic    
,act1 as added by subsection 7a71       
applies only with respect to a drug for 
which an application or supplemental    
application described in subsection     
7a77#a77;,b77i7 of such section #eje;,f 
is first approved under section #eje7;c7
 of such ,act 7#ba ,u4,s4,c4 #cee7;c77  
or section #cea7;a7 of the ,public      
,health ,service ,act 7#db ,u4,s4,c4    
#bfb7;a77 on or after the date of the   
enactment of this ,act4  7c7 ,conforming
 amendments  7#a7 ,relation to pediatric
 exclusivity for drugs ,section #eje;,a 
of the ,federal ,food1 ,drug1 and       
,cosmetic ,act 7#ba ,u4,s4,c4 #cee;a7 is
 amended-- 7,a7 in subsection 7b71 by   
adding at the end the following3  7#c7  
,relation to exclusivity for a drug     
approved for a new indication for a rare
 disease or condition ,notwithstanding  
the references in subsection 7b77#a7 to 
the lengths of the exclusivity periods  
after application of pediatric          

exclusivity1 the #f-month extensions    
described in subsection 7b77#a7 shall be
 in addition to any extensions under    
section #eje;,f4  2 and  7,b7 in        
subsection 7c71 by adding at the end the
 following3  7#c7 ,relation to          
exclusivity for a drug approved for a   
new indication for a rare disease or    
condition ,notwithstanding the          
references in subsection 7c77#a7 to the 
lengths of the exclusivity periods after
 application of pediatric exclusivity1  
the #f-month extensions described in    
subsection 7c77#a7 shall be in addition 
to any extensions under section #eje;,f4
  4  7#b7 ,relation to exclusivity for  
new qualified infectious disease        
products that are drugs ,subsection 7b7 
of section #eje;,e of the ,federal      
,food1 ,drug1 and ,cosmetic ,act 7#ba   
,u4,s4,c4 #cee;f7 is amended--  7,a7 by 
amending the subsection heading to read 
as follows3 ,relation to pediatric      
exclusivity and exclusivity for a drug  
approved for a new indication for a rare

 disease or condition2 and  7,b7 by     
striking any extension of the period    
under section #eje;,a and inserting any 
extension of the periods under sections 
#eje;,a and #eje;,f1 as applicable14    
7#c7 ,relation to pediatric exclusivity 
for biological products ,section #cea7m7
 of the ,public ,health ,service ,act   
7#db ,u4,s4,c4 #bfb7m77 is amended by   
adding at the end the following3  7#e7  
,relation to exclusivity for a          
biological product approved for a new   
indication for a rare disease or        
condition ,notwithstanding the          
references in paragraphs 7#b77;,a71     
7#b77;,b71 7#c77;,a71 and 7#c77;,b7 to  
the lengths of the exclusivity periods  
after application of pediatric          
exclusivity1 the #f-month extensions    
described in such paragraphs shall be in
 addition to any extensions under       
section #eje;,f4  4