,i  #aaf? ,,congress  #a/ ,session  ,h4 
,r4 #edjb  ,,9 ,,! ,,h\se ,,(           
,,repres5tatives  ,decemb] #aa1         
#bjai,mr4 ,got!im] 7= himself & ,mr4    
,upton7 introduc$ ! foll[+ bill2 :i* 0  
ref]r$ to ! ,committee on ,ways &       
,means1 & 9 addition to ! ,committee on 
,en]gy & ,comm]ce1 = a p]iod to be      
subsequ5tly det]m9$ by ! ,speak]1 9 ea* 
case = consid]ation ( su* provisions z  
fall )9 ! jurisdiction ( ! committee    
conc]n$  ,a ,,bill  ,to direct !        
,secret>y ( ,heal? & ,human ,s]vices1   
act+ ?r\gh ! ,commission] ( ,food &     
,drugs1 to conduct a /udy on high-risk1 
high-rew>d drugs1 & = o!r purposes4  #a4
 ,%ort title ,?is ,act may be cit$ z !  
,protect+ ,am]ica's ,life ,sav+ ,m$ic9es
 ,act ( #bjai4  #b4 ,/udy on high-risk1 
high-rew>d drugs  7a7 ,9 g5]al ,n lat]  
?an #ahj days aft] ! date ( ! enactm5t (
 ?is ,act1 ! ,secret>y ( ,heal? & ,human
 ,s]vices1 act+ ?r\gh ! ,commission] (  
,food & ,drugs1 %all conduct a /udy to  
det]m9e :i* ( ! drugs t are be+ te/$ 7z 

( su* date ( enactm5t7 "u subsection 7i7
 ( section #eje ( ! ,f$]al ,food1 ,drug1
 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cee7  
are unlikely to be approv$ "u subsection
 7c7 ( su* section1 b w\ld1 if approv$1 
address an unmet m$ical ne$ = ! treatm5t
 ( a s]i\s or life-?reat5+ disease or   
condition or a r>e disease or condition4
  7b7 ,submission to ,treasury ,n lat]  
?an #ahj days aft] ! completion ( ! /udy
 "u subsection 7a71 ! ,secret>y ( ,heal?
 & ,human ,s]vices1 act+ ?r\gh !        
,commission] ( ,food & ,drugs1 %all     
transmit to ! ,secret>y ( ! ,treasury   
7or ! ,secret>y's delegate7 a li/ ( !   
drugs t ! ,secret>y ( ,heal? & ,human   
,s]vices det]m9es meets ! crit]ia       
specifi$ 9 subsection 7a74  #c4 ,cr$it =
 cl9ical te/+ exp5ses = c]ta9 high-risk1
 high-rew>d drugs  7a7 ,9 g5]al ,subp>t 
,d ( "p ,,iv ( sub*apt] ,a ( *apt] #a ( 
! ,int]nal ,rev5ue ,code ( #aihf is     
am5d$ by add+ at ! end ! foll[+ new     
section3  #de,t4 ,cl9ical te/+ exp5ses =
 c]ta9 high-risk1 high-rew>d drugs  7a7 

,9 g5]al ,= purposes ( section #ch1 !   
cr$it det]m9$ "u ?is section = ! taxable
 ye> is an am\nt equal to #be 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#b7
 ,cl9ical te/+ ,! t]m cl9ical te/+ means
 any human cl9ical te/+-- 7,a7 :i* is   
c>ri$ out ) respect to a drug on a li/  
submitt$ to ! ,secret>y "u subsection   
7b7 ( ! ,protect+ ,am]ica's ,life ,sav+ 
,m$ic9es ,act ( #bjai1  7,b7 :i*        
occurs-- 7i7 aft] ! date su* li/ is s   
submitt$1 &  7ii7 be=e ! date on :i* an 
application ) respect to su* drug is    
approv$ "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 ,act4  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 ,special rules  7#a7 ,c]ta9 rules   
made applicable ,rules simil> to ! rules
 ( p>agraphs 7#a7 & 7#b7 ( section      
#da7;f7 %all apply = purposes ( ?is     
section4  7#b7 ,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  4  7b7 ,cr$it 
made "p ( g5]al bus9ess cr$it           
,subsection 7b7 ( section #ch ( !       
,int]nal ,rev5ue ,code ( #aihf is am5d$ 
by /rik+ plus at ! end ( p>agraph 7#ca71
 by /rik+ ! p]iod at ! end ( p>agraph   
7#cb7 & ins]t+ 1 plus1 & by add+ at !   
end ! foll[+ new p>agraph3  7#cc7 !     
cr$it det]m9$ "u section #de,t4  4  7c7 

,cl]ical am5dm5t ,! table ( sections =  
subp>t ,d ( "p ,,iv ( sub*apt] ,a (     
*apt] #a ( su* ,code is am5d$ by add+ at
 ! end ! foll[+ new item3  ,sec4 #de,t4 
,cl9ical te/+ exp5ses = c]ta9 high-risk1
 high-rew>d drugs44  7d7 ,effective date
 ,! am5dm5ts made by ?is section %all   
apply to taxable ye>s beg9n+ aft] ! date
 ( ! enactm5t ( ?is ,act4