,i  #aaith ,,congress  #b;d ,session    
,h4 ,r4 #gfic  ,,in ,,the ,,house ,,of  
,,representatives  ,february #be1       
#bjbf,mr4 ,gottheimer 7for himself and  
,mr4 ,bacon7 introduced the following   
bill2 which was referred to the         
,committee on ,energy and ,commerce  ,a 
,,bill  ,to mitigate the effects of the 
,,covid-#ai pandemic on incentives under
 the ,federal ,food1 ,drug1 and         
,cosmetic ,act for the development of   
orphan drugs1 and for other purposes4   
#a4 ,short title ,this ,act may be cited
 as ,leo's ,law4  #b4 ,mitigation of    
effects of ,,covid-#ai pandemic on      
orphan-drug development incentives  7a7 
,in general ,in the case of a covered   
orphan drug1 each of the following      
exclusivity periods is deemed to be     
extended by #ahj days1 so long as such  
period is not expired3  7#a7 ,the       
#ab-year period referred to in          
subparagraph 7,a7 of section #cea7k77#g7
 of the ,public ,health ,service ,act   
7#db ,u4,s4,c4 #bfb7k77#g774  7#b7 ,the 

#e-year period referred to in subsection
 7c77#c77;,e77ii7 and subsection        
7j77#e77;,f77ii7 of section #eje of the 
,federal ,food1 ,drug1 and ,cosmetic    
,act 7#ba ,u4,s4,c4 #cee74  7#c7 ,the   
#c-year period referred to in each of   
clauses 7iii7 and 7iv7 of subsection    
7c77#c77;,e7 and clauses 7iii7 and 7iv7 
of subsection 7j77#e77;,f7 of section   
#eje of the ,federal ,food1 ,drug1 and  
,cosmetic ,act 7#ba ,u4,s4,c4 #cee74    
7#d7 ,the #g-year period referred to in 
section #ebg7;a7 of the ,federal1 ,food1
 ,drug1 and ,cosmetic ,act 7#ba         
,u4,s4,c4 #cfj;cc74  7#e7 ,in the case  
of a covered orphan drug with one or    
more certifications specified in clauses
 7ii71 7iii71 and 7iv7 of section       
#eje7;b77#b77;,a7 of the ,federal ,food1
 ,drug1 and ,cosmetic ,act 7#ba         
,u4,s4,c4 #cee7;b77#b77;,a771 or in     
subclauses 7,,ii71 7,,iii71 and 7,,iv7  
of section #eje7;j77#b77;,a77vii7 of    
such ,act 7#ba ,u4,s4,c4                
#cee7;j77#b77;,a77vii771 each           

corresponding patent-related            
approval-delay period 7other than a     
patent for which the information        
required pursuant to subsection 7b7 or  
7c7 of section #eje of the ,federal     
,food1 ,drug1 and ,cosmetic ,act 7#ba   
,u4,s4,c4 #cee7 has not been filed74    
7b7 ,conforming extensions ,in addition 
to the periods extended under subsection
 7a7 for a covered orphan drug1 the     
following periods are each deemed to be 
extended by #ahj days3 7#a7 ,the #d-year
 period referred to in subparagraph 7,b7
 of section #cea7k77#g7 of the ,public  
,health ,service ,act 7#db ,u4,s4,c4    
#bfb7k77#g774  7#b7 ,the #d-year1       
#dh-month1 and #g and one-half-year     
periods referred to in subsection       
7c77#c77;,e77ii7 and subsection         
7j77#e77;,f77ii7 of section #eje of the 
,federal ,food1 ,drug1 and ,cosmetic    
,act 7#ba ,u4,s4,c4 #cee74  7c7         
,definitions ,in this section3  7#a7    
,the term covered orphan drug means an  
orphan drug for which-- 7,a7 an         

application is submitted under section  
#eje7;i7 of the ,federal ,food1 ,drug1  
and ,cosmetic ,act 7#ba ,u4,s4,c4       
#cee7;i77 during the ,,covid-#ai        
emergency period 7without regard to     
whether the same applicant has submitted
 such application for the same drug     
before ,december #a1 #bjai1 for a       
different rare disease or condition72   
7,b7 an application under section       
#eje7;b7 of the ,federal ,food1 ,drug1  
and ,cosmetic ,act or under section     
#cea7;a7 of the ,public ,health ,service
 ,act 7or a supplemental application1 as
 the case may be7 is approved pursuant  
to the investigational new drug         
application referred to in paragraph    
7#a72 and  7,c7 there is no approved    
indication that is not for a rare       
disease or condition4  7#b7 ,the term   
corresponding patent-related approval   
delay period1 with respect to a covered 
orphan drug1 means the period ending    
with the last applicable date for the   
approval of an application within the   

meaning of subparagraph 7,a71 7,b71 or  
7,c7 of section #eje7;c77#c7 of the     
,federal1 ,food1 ,drug1 and ,cosmetic   
,act 7#ba ,u4,s4,c4 #cee7;c77#c771 or   
clause 7i71 7ii71 or 7iii7 of section   
#eje7;j77#e77;,b7 of such ,act 7#ba     
,u4,s4,c4 #cee7;j77#e77;,b771 whichever 
applies pursuant to the applicable      
patent certification4  7#c7 ,the term   
orphan drug means a drug that the       
,secretary has designated as a drug for 
a rare disease or condition under       
section #ebf7;a7 of the ,federal1 ,food1
 ,drug1 and ,cosmetic ,act 7#ba         
,u4,s4,c4 #cfj;bb7a774  7#d7 ,the term  
,,covid-#ai emergency period means the  
period beginning on ,december #a1 #bjai1
 and ending on the date that is not     
later than #abj days before the date on 
which the emergency period 7as defined  
in section #aace7;g77#a77;,b7 of the    
,social ,security ,act 7#db ,u4,s4,c4   
#acbj;b-#e7;g77#a77;,b777 terminates4   
7#e7 ,the term rare disease or condition
 has the meaning given such term in     

section #ebf of the ,federal ,food1     
,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4
 #cfj;bb74  7d7 ,effective date ,this   
section takes effect upon the date of   
the enactment of this ,act1 without     
regard to whether the ,secretary has    
issued guidance or regulations regarding
 the implementation of this ,act4