,i  #aai? ,,congress  #b;d ,session  ,h4
 ,r4 #gfic  ,,9 ,,! ,,h\se ,,(          
,,repres5tatives  ,febru>y #be1         
#bjbf,mr4 ,got!im] 7= himself & ,mr4    
,bacon7 introduc$ ! foll[+ bill2 :i* 0  
ref]r$ to ! ,committee on ,en]gy &      
,comm]ce  ,a ,,bill  ,to mitigate !     
effects ( ! ,,covid-#ai p&emic on       
inc5tives "u ! ,f$]al ,food1 ,drug1 &   
,cosmetic ,act = ! developm5t ( orphan  
drugs1 & = o!r purposes4  #a4 ,%ort     
title ,?is ,act may be cit$ z ,leo's    
,law4  #b4 ,mitigation ( effects (      
,,covid-#ai p&emic on orphan-drug       
developm5t inc5tives  7a7 ,9 g5]al ,9 ! 
case ( a cov]$ orphan drug1 ea* ( !     
foll[+ exclusivity p]iods is deem$ to be
 ext5d$ by #ahj days1 s long z su* p]iod
 is n expir$3  7#a7 ,! #ab-ye> p]iod    
ref]r$ to 9 subp>agraph 7,a7 ( section  
#cea7k77#g7 ( ! ,public ,heal? ,s]vice  
,act 7#db ,u4,s4,c4 #bfb7k77#g774  7#b7 
,! #e-ye> p]iod ref]r$ to 9 subsection  
7c77#c77;,e77ii7 & subsection           
7j77#e77;,f77ii7 ( section #eje ( !     

,f$]al ,food1 ,drug1 & ,cosmetic ,act   
7#ba ,u4,s4,c4 #cee74  7#c7 ,! #c-ye>   
p]iod ref]r$ to 9 ea* ( clauses 7iii7 & 
7iv7 ( subsection 7c77#c77;,e7 & clauses
 7iii7 & 7iv7 ( subsection 7j77#e77;,f7 
( section #eje ( ! ,f$]al ,food1 ,drug1 
& ,cosmetic ,act 7#ba ,u4,s4,c4 #cee74  
7#d7 ,! #g-ye> p]iod ref]r$ to 9 section
 #ebg7;a7 ( ! ,f$]al1 ,food1 ,drug1 &   
,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;cc74 
7#e7 ,9 ! case ( a cov]$ orphan drug )  
"o or m c]tifications specifi$ 9 clauses
 7ii71 7iii71 & 7iv7 ( section          
#eje7;b77#b77;,a7 ( ! ,f$]al ,food1     
,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4  
#cee7;b77#b77;,a771 or 9 subclauses     
7,,ii71 7,,iii71 & 7,,iv7 ( section     
#eje7;j77#b77;,a77vii7 ( su* ,act 7#ba  
,u4,s4,c4 #cee7;j77#b77;,a77vii771 ea*  
correspond+ pat5t-relat$ approval-delay 
p]iod 7o!r ?an a pat5t = :i* ! in=mation
 requir$ pursuant to subsection 7b7 or  
7c7 ( section #eje ( ! ,f$]al ,food1    
,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4  
#cee7 has n be5 fil$74  7b7 ,con=m+     

ext5sions ,9 addition to ! p]iods ext5d$
 "u subsection 7a7 = a cov]$ orphan     
drug1 ! foll[+ p]iods are ea* deem$ to  
be ext5d$ by #ahj days3 7#a7 ,! #d-ye>  
p]iod ref]r$ to 9 subp>agraph 7,b7 (    
section #cea7k77#g7 ( ! ,public ,heal?  
,s]vice ,act 7#db ,u4,s4,c4             
#bfb7k77#g774  7#b7 ,! #d-ye>1 #dh-mon?1
 & #g & "o-half-ye> p]iods ref]r$ to 9  
subsection 7c77#c77;,e77ii7 & subsection
 7j77#e77;,f77ii7 ( section #eje ( !    
,f$]al ,food1 ,drug1 & ,cosmetic ,act   
7#ba ,u4,s4,c4 #cee74  7c7 ,def9itions  
,9 ?is section3  7#a7 ,! t]m cov]$      
orphan drug means an orphan drug = :i*--
 7,a7 an application is submitt$ "u     
section #eje7;i7 ( ! ,f$]al ,food1      
,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4  
#cee7;i77 dur+ ! ,,covid-#ai em]g5cy    
p]iod 7)\t reg>d to :e!r ! same         
applicant has submitt$ su* application =
 ! same drug be=e ,decemb] #a1 #bjai1 = 
a diff]5t r>e disease or condition72    
7,b7 an application "u section #eje7;b7 
( ! ,f$]al ,food1 ,drug1 & ,cosmetic    

,act or "u section #cea7;a7 ( ! ,public 
,heal? ,s]vice ,act 7or a supplem5tal   
application1 z ! case may be7 is approv$
 pursuant to ! inve/igational new drug  
application ref]r$ to 9 p>agraph 7#a72 &
  7,c7 !re is no approv$ indication t is
 n = a r>e disease or condition4  7#b7  
,! t]m correspond+ pat5t-relat$ approval
 delay p]iod1 ) respect to a cov]$      
orphan drug1 means ! p]iod end+ ) ! la/ 
applicable date = ! approval ( an       
application )9 ! mean+ ( subp>agraph    
7,a71 7,b71 or 7,c7 ( section           
#eje7;c77#c7 ( ! ,f$]al1 ,food1 ,drug1 &
 ,cosmetic ,act 7#ba ,u4,s4,c4          
#cee7;c77#c771 or clause 7i71 7ii71 or  
7iii7 ( section #eje7;j77#e77;,b7 ( su* 
,act 7#ba ,u4,s4,c4 #cee7;j77#e77;,b771 
:i*ev] applies pursuant to ! applicable 
pat5t c]tification4  7#c7 ,! t]m orphan 
drug means a drug t ! ,secret>y has     
designat$ z a drug = a r>e disease or   
condition "u section #ebf7;a7 ( !       
,f$]al1 ,food1 ,drug1 & ,cosmetic ,act  
7#ba ,u4,s4,c4 #cfj;bb7a774  7#d7 ,! t]m

 ,,covid-#ai em]g5cy p]iod means ! p]iod
 beg9n+ on ,decemb] #a1 #bjai1 & end+ on
 ! date t is n lat] ?an #abj days be=e !
 date on :i* ! em]g5cy p]iod 7z def9$ 9 
section #aace7;g77#a77;,b7 ( ! ,social  
,security ,act 7#db ,u4,s4,c4           
#acbj;b-#e7;g77#a77;,b777 t]m9ates4     
7#e7 ,! t]m r>e disease or condition has
 ! mean+ giv5 su* t]m 9 section #ebf ( !
 ,f$]al ,food1 ,drug1 & ,cosmetic ,act  
7#ba ,u4,s4,c4 #cfj;bb74  7d7 ,effective
 date ,?is section takes effect ^u !    
date ( ! enactm5t ( ?is ,act1 )\t reg>d 
to :e!r ! ,secret>y has issu$ guidance  
or regulations reg>d+ ! implem5tation ( 
?is ,act4