,i  #aad? ,,congress  #a/ ,session  ,h4 
,r4 #ceci  ,,9 ,,! ,,h\se ,,(           
,,repres5tatives  ,septemb] #ag1 #bjae  
,mr4 ,b\/any 7= himself1 ,mr4 ,?ompson (
 ,cali=nia1 ,mr4 ,pauls51 ,mr4 ,%imkus1 
& ,mr4 ,g5e ,gre5 ( ,texas7 introduc$ ! 
foll[+ bill2 :i* 0 ref]r$ to !          
,committee on ,ways & ,means  ,a ,,bill 
,to am5d ! ,int]nal ,rev5ue ,code (     
#aihf to all[ a cr$it aga9/ tax =       
cl9ical te/+ exp5ses = qualifi$         
infecti\s disease drugs & rapid         
diagno/ic te/s4  #a4 ,%ort title ,?is   
,act may be cit$ z ! ,re9vigorat+       
,antibiotic & ,diagno/ic ,innovation    
,act ( #bjae4  #b4 ,cl9ical te/+ exp5ses
 = qualifi$ infecti\s disease products  
7a7 ,9 g5]al ,subp>t ,d ( "p ,,iv (     
sub*apt] ,a ( *apt] #a ( ! ,int]nal     
,rev5ue ,code ( #aihf is am5d$ by add+  
at ! end ! foll[+ new section3  #de,s4  
,cl9ical te/+ exp5ses = qualifi$        
infecti\s disease products  7a7 ,g5]al  
rule ,= purposes ( section #ch1 !       
qualifi$ infecti\s disease product cr$it

 det]m9$ "u ?is section = ! taxable ye> 
is an am\nt equal to #ej p]c5t ( !      
qualifi$ cl9ical te/+ exp5ses = !       
taxable ye>4  7b7 ,qualifi$ cl9ical te/+
 exp5ses ,= purposes ( ?is section--    
7#a7 ,qualifi$ cl9ical te/+ exp5ses     
7,a7 ,9 g5]al ,except z o!rwise provid$ 
9 ?is p>agraph1 ! t]m qualifi$ cl9ical  
te/+ exp5ses means ! am\nts :i* are paid
 or incurr$ by ! taxpay] dur+ ! taxable 
ye> :i* w\ld be describ$ 9 subsection   
7b7 ( section #da if su* subsection 7   
appli$ ) ! modifications set =? 9       
subp>agraph 7,b74  7,b7 ,modifications  
,= purposes ( subp>agraph 7,a71         
subsection 7b7 ( section #da %all be    
appli$-- 7i7 by sub/itut+ cl9ical te/+ =
 qualifi$ rese>* ea* place x appe>s 9   
p>agraphs 7#b7 & 7#c7 ( su* subsection1 
&  7ii7 by sub/itut+ #ajj p]c5t = #fe   
p]c5t 9 p>agraph 7#c77;,a7 ( su*        
subsection4  7,c7 ,exclusion = am\nts   
fund$ by grants1 etc ,! t]m qualifi$    
cl9ical te/+ exp5ses %all n include any 
am\nt to ! ext5t su* am\nt is fund$ by  

any grant1 contract1 or o!rwise by ano!r
 p]son 7or any gov]nm5tal entity74  7,d7
 ,special rule ,= purposes ( ?is        
p>agraph1 section #da %all be deem$ to  
rema9 9 effect = p]iods aft] enactm5t ( 
?is section4  7#b7 ,cl9ical te/+  7,a7  
,9 g5]al ,! t]m cl9ical te/+ means any  
human cl9ical te/+-- 7i7 :i* is c>ri$   
out "u an exemption = a drug be+ te/$ z 
an antibiotic or antifungal drug "u     
section #eje7;i7 ( ! ,f$]al ,food1      
,drug1 & ,cosmetic ,act 7or regulations 
issu$ "u su* section71  7ii7 :i* occurs 
be=e ! date on :i* an application )     
respect to su* drug is approv$ "u       
section #eje7;b7 ( su* ,act or1 if !    
drug is a biological product1 be=e !    
date on :i* a lic5se = su* drug is issu$
 "u section #cea ( ! ,public ,heal?     
,s]vice ,act1 &  7iii7 :i* is conduct$  
by or on behalf ( ! taxpay] to :om      
exemption "u section #eje7;i7 ( su* ,act
 is grant$4  7,b7 ,te/+ mu/ be relat$ to
 use z qualifi$ infecti\s disease       
product ,human cl9ical te/+ %all be tak5

 into acc\nt "u subp>agraph 7,a7 only to
 ! ext5t su* te/+ is relat$ to ! use ( !
 drug z a qualifi$ infecti\s disease    
product4  7c7 ,coord9ation ) cr$it =    
increas+ rese>* exp5ditures  7#a7 ,9    
g5]al ,except z provid$ 9 p>agraph 7#b71
 any qualifi$ cl9ical te/+ exp5ses = a  
taxable ye> to :i* an election "u ?is   
section applies %all n be tak5 into     
acc\nt = purposes ( det]m9+ ! cr$it     
all[able "u section #da = su* taxable   
ye>4  7#b7 ,exp5ses includ$ 9 det]m9+   
base p]iod rese>* exp5ses ,any qualifi$ 
cl9ical te/+ exp5ses = any taxable ye>  
:i* are qualifi$ rese>* exp5ses 7)9 !   
mean+ ( section #da7;b77 %all be tak5   
into acc\nt 9 det]m9+ base p]iod rese>* 
exp5ses = purposes ( apply+ section #da 
to subsequ5t taxable ye>s4  7d7         
,def9itions & special rules  7#a7       
,qualifi$ infecti\s disease product ,=  
purposes ( ?is section1 ! t]m qualifi$  
infecti\s disease product means any drug
 or biological product = human use t--  
7,a7 is int5d$ to treat a s]i\s or      

life-?reat5+ infection1 includ+ ^? caus$
 by--  7i7 an antibact]ial or antifungal
 resi/ant pa?og5 7includ+ novel or em]g+
 infecti\s pa?og5s71 or  7ii7 qualify+  
pa?og5s li/$ by ! ,secret>y ( ,heal? &  
,human ,s]vices "u section #eje;,e7f7 ( 
! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 
7#ba ,u4,s4,c4 #cea et seq471 &  7,b7 is
 int5d$ to treat an infection = :i* !re 
is an unmet m$ical ne$ z def9$ by !     
,secret>y ( ,heal? & ,human ,s]vices4   
7#b7 ,special limitation on =eign te/+  
7,a7 ,9 g5]al ,no cr$it %all be all[$ "u
 ?is section ) respect to any cl9ical   
te/+ conduct$ outside ! ,unit$ ,/ates   
unless--  7i7 su* te/+ is conduct$      
outside ! ,unit$ ,/ates because !re is  
an insuffici5t te/+ population 9 !      
,unit$ ,/ates1 &  7ii7 su* te/+ is      
conduct$ by a ,unit$ ,/ates p]son or by 
any o!r p]son :o is n relat$ to !       
taxpay] to :om exemption "u section     
#eje7;i7 ( ! ,f$]al ,food1 ,drug1 &     
,cosmetic ,act is grant$4  7,b7         
,insuffici5t te/+ population ,= purposes

 ( ?is section1 ! te/+ population 9 !   
,unit$ ,/ates is insuffici5t if !re are 
n )9 ! ,unit$ ,/ates ! numb] ( available
 & appropriate human subjects ne$$ to   
produce reliable & timely data f !      
cl9ical inve/igation4  7#c7 ,c]ta9 rules
 made applicable ,rules simil> to !     
rules ( p>agraphs 7#a7 & 7#b7 ( section 
#da7;f7 %all apply = purposes ( ?is     
section4  7#d7 ,election ,?is section   
%all apply to any taxpay] = any taxable 
ye> only if su* taxpay] elects 7at su*  
"t & 9 su* mann] z ! ,secret>y may by   
regulations prescribe7 to h ?is section 
apply = su* taxable ye>4  7e7           
,transf]ability  7#a7 ,9 g5]al ,any     
taxpay] hold+ a cr$it "u ?is section may
 transf] = valuable consid]ation unus$ b
 o!rwise all[able cr$it = use by a      
qualifi$ ph>maceutical rese>* taxpay]4  
,a taxpay] t transf]s any am\nt ( cr$it 
"u ?is section %all file a notification 
( su* transf] to ! ,secret>y 9          
accordance ) proc$ures & =ms prescrib$  
by ! ,secret>y4  7#b7 ,use ( transf]r$  

cr$it ,any qualifi$ ph>maceutical rese>*
 taxpay] t receives cr$it t has be5     
transf]r$ %all use su* cr$it = ! taxable
 ye> 9 :i* ! transf] occurr$4 ,any unus$
 am\nts ( su* cr$it may be c>ri$ back or
 =w>d to o!r taxable ye>s 9 accordance )
 section #ci4  7#c7 ,def9ition (        
qualifi$ ph>maceutical rese>* taxpay] ,=
 purposes ( ?is section1 ! t]m qualifi$ 
ph>maceutical rese>* taxpay] means any  
dome/ic corporation ! prim>y mission (  
:i* is ph>maceutical rese>* or          
developm5t4  4  7b7 ,made "p ( bus9ess  
cr$it ,section #ch7;b7 ( su* ,code is   
am5d$ by /rik+ plus at ! end ( p>agraph 
7#ce71 by /rik+ ! p]iod at ! end (      
p>agraph 7#cf7 & ins]t+ 1 plus1 & by    
add+ at ! end ! foll[+ new p>agraph3    
7#cg7 ! qualifi$ infecti\s disease      
product cr$it det]m9$ "u section        
#de,s7a74  4  7c7 ,cl]ical am5dm5ts ,!  
table ( sections = subp>t ,d ( "p ,,iv (
 sub*apt] ,a ( *apt] #a ( su* ,code is  
am5d$ by add+ at ! end ! foll[+ new     
item3  #de,s4 ,cl9ical te/+ exp5ses =   

qualifi$ infecti\s disease products4  4 
7d7 ,effective date ,! am5dm5t made by  
?is section %all apply to am\nts paid or
 incurr$ aft] ! date ( ! enactm5t ( ?is 
,act4  #c4 ,cl9ical te/+ exp5ses = rapid
 infecti\s diseases diagno/ic te/s  7a7 
,9 g5]al ,subp>t ,d ( "p ,,iv ( sub*apt]
 ,a ( *apt] #a ( ! ,int]nal ,rev5ue     
,code ( #aihf1 z am5d$ by section #b1 is
 am5d$ by add+ at ! end ! foll[+ new    
section3  #de,t4 ,cl9ical te/+ exp5ses =
 rapid infecti\s diseases diagno/ic te/s
  7a7 ,g5]al rule ,= purposes ( section 
#ch1 ! cr$it det]m9$ "u ?is section = ! 
taxable ye> is an am\nt equal to #ej    
p]c5t ( ! qualifi$ cl9ical te/+ exp5ses 
= ! taxable ye>4  7b7 ,qualifi$ cl9ical 
te/+ exp5ses ,= purposes ( ?is section--
 7#a7 ,qualifi$ cl9ical te/+ exp5ses    
7,a7 ,9 g5]al ,except z o!rwise provid$ 
9 ?is p>agraph1 ! t]m qualifi$ cl9ical  
te/+ exp5ses means ! am\nts :i* are paid
 or incurr$ by ! taxpay] dur+ ! taxable 
ye> :i* w\ld be describ$ 9 subsection   
7b7 ( section #da if su* subsection 7   

appli$ ) ! modifications set =? 9       
subp>agraph 7,b74  7,b7 ,modifications  
,= purposes ( subp>agraph 7,a71         
subsection 7b7 ( section #da %all be    
appli$-- 7i7 by sub/itut+ cl9ical te/+ =
 qualifi$ rese>* ea* place x appe>s 9   
p>agraphs 7#b7 & 7#c7 ( su* subsection1 
&  7ii7 by sub/itut+ #ajj p]c5t = #fe   
p]c5t 9 p>agraph 7#c77;,a7 ( su*        
subsection4  7,c7 ,exclusion = am\nts   
fund$ by grants1 etc ,! t]m qualifi$    
cl9ical te/+ exp5ses %all n include any 
am\nt to ! ext5t su* am\nt is fund$ by  
any grant1 contract1 or o!rwise by ano!r
 p]son 7or any gov]nm5tal entity74  7,d7
 ,special rule ,= purposes ( ?is        
p>agraph1 section #da %all be deem$ to  
rema9 9 effect = p]iods aft] enactm5t ( 
?is section4  7#b7 ,cl9ical te/+  7,a7  
,9 g5]al ,! t]m cl9ical te/+ means any  
human cl9ical te/+-- 7i7 :i* is c>ri$   
out "u an exemption = a device be+ te/$ 
"u section #ebj7;g7 ( ! ,f$]al ,food1   
,drug1 & ,cosmetic ,act 7or regulations 
issu$ "u su* section71  7ii7 :i* is     

relat$ only to su* use z a qualifi$     
rapid infecti\s diseases diagno/ic te/1 
7iii7 :i* occurs be=e ! date on :i* an  
application ) respect to su* device     
receives prem>ket approval1 if requir$1 
"u section #eae ( su* ,act1 or receives 
cle>ance1 if requir$1 "u section #eaj7k7
 ( su* ,act1 &  7iv7 :i* is conduct$ by 
or on behalf ( ! taxpay] to :om !       
exemption "u section #ebj7;g7 ( su* ,act
 0 grant$4  7c7 ,coord9ation ) cr$it =  
increas+ rese>* exp5ditures  7#a7 ,9    
g5]al ,except z provid$ 9 p>agraph 7#b71
 any qualifi$ cl9ical te/+ exp5ses = a  
taxable ye> to :i* an election "u ?is   
section applies %all n be tak5 into     
acc\nt = purposes ( det]m9+ ! cr$it     
all[able "u section #da = su* taxable   
ye>4  7#b7 ,exp5ses includ$ 9 det]m9+   
base p]iod rese>* exp5ses ,any qualifi$ 
cl9ical te/+ exp5ses = any taxable ye>  
:i* are qualifi$ rese>* exp5ses 7)9 !   
mean+ ( section #da7;b77 %all be tak5   
into acc\nt 9 det]m9+ base p]iod rese>* 
exp5ses = purposes ( apply+ section #da 

to subsequ5t taxable ye>s4  7d7         
,def9itions & special rules  7#a7       
,qualifi$ rapid infecti\s diseases      
diagno/ic te/ ,= purposes ( ?is section1
 ! t]m qualifi$ rapid infecti\s diseases
 diagno/ic te/ means an 9-vitro         
diagno/ic 7,,ivd7 device t provides     
results 9 less ?an f\r h\rs & t is us$  
to id5tify or detect ! pres5ce1         
conc5tration1 or *>act]i/ics ( a s]i\s  
or life-?reat5+ infection1 includ+ ^?   
caus$ by 7#a7 an antibact]ial or        
antifungal resi/ant pa?og51 includ+     
novel or em]g+ infecti\s pa?og5s or 7#b7
 qualify+ pa?og5s li/$ by ! ,secret>y ( 
,heal? & ,human ,s]vices "u ,*apt] ,v   
7#ba ,u4,s4,c4 #cea et seq47 section    
#eje;,e7f74  7#b7 ,special limitation on
 =eign te/+  7,a7 ,9 g5]al ,no cr$it    
%all be all[$ "u ?is section ) respect  
to any cl9ical te/+ conduct$ outside !  
,unit$ ,/ates unless--  7i7 su* te/+ is 
conduct$ outside ! ,unit$ ,/ates because
 !re is an insuffici5t te/+ population 9
 ! ,unit$ ,/ates1 &  7ii7 su* te/+ is   

conduct$ by a ,unit$ ,/ates p]son or by 
any o!r p]son :o is n relat$ to !       
taxpay] to :om ! exemption "u section   
#ebj7;g7 ( ,f$]al ,food1 ,drug1 &       
,cosmetic ,act 0 grant$4  7,b7          
,insuffici5t te/+ population ,= purposes
 ( ?is section1 ! te/+ population 9 !   
,unit$ ,/ates is insuffici5t if !re are 
n )9 ! ,unit$ ,/ates ! numb] ( available
 & appropriate human subjects ne$$ to   
produce reliable & timely data f !      
cl9ical inve/igation4  7#c7 ,c]ta9 rules
 made applicable ,rules simil> to !     
rules ( p>agraphs 7#a7 & 7#b7 ( section 
#da7;f7 %all apply = purposes ( ?is     
section4  7#d7 ,election ,?is section   
%all apply to any taxpay] = any taxable 
ye> only if su* taxpay] elects 7at su*  
"t & 9 su* mann] z ! ,secret>y may by   
regulations prescribe7 to h ?is section 
apply = su* taxable ye>4  7e7           
,transf]ability  7#a7 ,9 g5]al ,any     
taxpay] hold+ a cr$it "u ?is section may
 transf] = valuable consid]ation unus$ b
 o!rwise all[able cr$it = use by a      

qualifi$ diagno/ics rese>* taxpay]4 ,a  
taxpay] t transf]s any am\nt ( cr$it "u 
?is section %all file a notification (  
su* transf] to ! ,secret>y 9 accordance 
) proc$ures & =ms prescrib$ by !        
,secret>y4  7#b7 ,use ( transf]r$ cr$it 
,any qualifi$ diagno/ics rese>* taxpay] 
t receives cr$it t has be5 transf]r$    
%all use su* cr$it = ! taxable ye> 9 :i*
 ! transf] occurr$4 ,any unus$ am\nts ( 
su* cr$it may be c>ri$ back or =w>d to  
o!r taxable ye>s 9 accordance ) section 
#ci4  7#c7 ,def9ition ( qualifi$        
diagno/ics rese>* taxpay] ,= purposes ( 
?is section1 ! t]m qualifi$ diagno/ics  
rese>* taxpay] means any dome/ic        
corporation t d]ives-- 7,a7 any gross   
income f rese>* or developm5t on        
diagno/ic te/s us$ to id5tify or detect 
! pres5ce1 conc5tration or *>act]i/ics (
 a s]i\s or life-?reat5+ infecti\s      
disease or pa?og52 or  7,b7 any gross   
income f rese>* or developm5t on        
qualifi$ infecti\s disease products )9 !
 mean+ giv5 to su* t]m 9 section        

#eje;,e7g7 ( ! ,f$]al1 ,food1 ,drug1 &  
,cosmetic ,act2 or  7,c7 m ?an #ej p]c5t
 ( its gross income f activities relat$ 
to heal? c>e4  4  7b7 ,made "p ( bus9ess
 cr$it ,section #ch7;b7 ( su* ,code1 z  
am5d$ by section #b1 is am5d$ by /rik+  
plus at ! end ( p>agraph 7#cf71 by /rik+
 ! p]iod at ! end ( p>agraph 7#cg7 &    
ins]t+ 1 plus1 & by add+ at ! end !     
foll[+ new p>agraph3  7#ch7 ! cr$it     
det]m9$ "u section #de,t7a74  4  7c7    
,cl]ical am5dm5t ,! table ( sections =  
subp>t ,d ( "p ,,iv ( sub*apt] ,a (     
*apt] #a ( su* ,code1 z am5d$ by section
 #b1 is am5d$ by add+ at ! end ! foll[+ 
new item3  ,sec4 #de,t4 ,cl9ical te/+   
exp5ses = rapid infecti\s diseases      
diagno/ic te/s4  4  7d7 ,effective date 
,! am5dm5t made by ?is section %all     
apply to am\nts paid or incurr$ aft] !  
date ( ! enactm5t ( ?is ,act4