,,ib  ,union ,cal5d> ,no4 #cc  #aaf?    
,,congress  #a/ ,session  ,h4 ,r4 #ife  
,report ,no4 #aaf-ee1 ,p>ts ,i & ,,ii   
,,9 ,,! ,,h\se ,,( ,,repres5tatives     
,febru>y #e1 #bjai ,mr4 ,cicill9e 7=    
himself1 ,mr4 ,s5s5br5n]1 ,mr4 ,nadl]1  
,mr4 ,coll9s ( ,georgia1 ,mr4 ,wel*1 &  
,mr4 ,mc,kinley7 introduc$ ! foll[+     
bill2 :i* 0 ref]r$ to ! ,committee on   
,en]gy & ,comm]ce1 & 9 addition to !    
,committee on ! ,judici>y1 = 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$  ,may #aj1 #bjai ,additional    
sponsors3 ,mr4 ,mead[s1 ,ms4 ,f9k5au]1  
,mr4 ,doggett1 ,mr4 ,cole1 ,mr4         
,gallagh]1 ,mr4 ,lip9ski1 ,mr4 ,ru%1    
,ms4 ,mc,collum1 ,mr4 ,pallone1 ,mr4    
,p]ry1 ,mr4 ,ruiz1 ,mrs4 ,d+ell1 ,ms4   
,e%oo1 ,ms4 ,matsui1 ,mrs4 ,craig1 ,mr4 
,tonko1 ,mr4 ,gohm]t1 ,mr4 ,van ,drew1  
,ms4 ,cl>ke ( ,new ,york1 ,mr4 ,c\rtney1
 ,mr4 ,allr$1 ,ms4 ,s*ak[sky1 ,mr4 ,cr[1
 ,mr4 ,gonzalez ( ,ohio1 ,mr4 ,l>son (  

,connecticut1 ,mr4 ,mc,adams1 ,mr4      
,s*rad]1 ,mr4 ,rodney ,davis ( ,ill9ois1
 ,mr4 ,pappas1 ,mr4 ,k5n$y1 ,ms4 ,davids
 ( ,kansas1 ,mr4 ,norcross1 ,ms4        
,spanb]g]1 ,mr4 ,quigley1 ,mr4 ,deut*1  
,mr4 ,langev91 ,mr4 ,coop]1 ,mrs4       
,mc,bath1 ,mr4 ,rask91 ,ms4             
,muc>sel-,p[ell1 ,mr4 ,/anton1 ,mr4     
,jordan1 ,ms4 ,wild1 ,mr4 ,coh51 ,mr4   
,kim1 ,ms4 ,s*ri]1 ,mr4 ,joyce ( ,ohio1 
,mr4 ,case1 ,mr4 ,khanna1 ,mr4 ,david   
,scott ( ,georgia1 ,ms4 ,h\lahan1 ,mr4  
,ca/5 ( ,ill9ois1 ,mr4 ,norman1 ,ms4    
,p+ree1 ,mr4 ,c>bajal1 ,mr4 ,smi? (     
,wa%+ton1 ,ms4 ,wexton1 ,mr4 ,cisn]os1  
,mr4 ,connolly1 ,ms4 ,und]wood1 ,ms4    
,g>cia ( ,texas1 ,ms4 ,m5g1 & ,mrs4     
,bu/os  ,may #aj1 #bjai ,report$ f !    
,committee on ,en]gy & ,comm]ce ) an    
am5dm5t ,/rike out all aft] ! enact+    
clause & ins]t ! "p pr9t$ 9 italic  ,may
 #aj1 #bjai ,report$ f ! ,committee on !
 ,judici>y2 committ$ to ! ,committee ( !
 ,:ole ,h\se on ! ,/ate ( ! ,union &    
ord]$ to be pr9t$ ,= text ( introduc$   

bill1 see copy ( bill z introduc$ on    
,febru>y #e1 #bjai  ,a ,,bill  ,to      
promote competition 9 ! m>ket = drugs & 
biological products by facilitat+ !     
timely entry ( l[]-co/ g5]ic & biosimil>
 v]sions ( ^? drugs & biological        
products4  #a4 ,%ort title ,?is ,act may
 be cit$ z ! ,creat+ & ,re/or+ ,equal   
,access to ,equival5t ,samples ,act (   
#bjai or ! ,,creates ,act ( #bjai4  #b4 
,actions = delays ( g5]ic drugs &       
biosimil> biological products  7a7      
,def9itions ,9 ?is section--  7#a7 ! t]m
 comm]cially reasonable1 m>ket-bas$ t]ms
 means-- 7,a7 a nondiscrim9atory price =
 ! sale ( ! cov]$ product at or bel[1 b 
n great] ?an1 ! mo/ rec5t :olesale      
acquisition co/ = ! drug1 z def9$ 9     
section #ahdg;,a7c77#f77;,b7 ( ! ,social
 ,security ,act 7#db ,u4,s4,c4          
#aciew-#c;a7c77#f77;,b772  7,b7 a s*$ule
 = deliv]y t results 9 ! transf] ( !    
cov]$ product to ! eligible product     
develop] consi/5t ) ! tim+ "u subsection
 7b77#b77;,a77iv72 &  7,c7 no additional

 conditions are impos$ on ! sale ( !    
cov]$ product2  7#b7 ! t]m cov]$        
product--  7,a7 means-- 7i7 any drug    
approv$ "u subsection 7c7 or 7j7 (      
section #eje ( ! ,f$]al ,food1 ,drug1 & 
,cosmetic ,act 7#ba ,u4,s4,c4 #cee7 or  
biological product lic5s$ "u subsection 
7a7 or 7k7 ( section #cea ( ! ,public   
,heal? ,s]vice ,act 7#db ,u4,s4,c4      
#bfb72  7ii7 any comb9ation ( a drug or 
biological product describ$ 9 clause    
7i72 or  7iii7 :5 reasonably necess>y to
 support approval ( an application "u   
section #eje ( ! ,f$]al ,food1 ,drug1 & 
,cosmetic ,act 7#ba ,u4,s4,c4 #cee71 or 
section #cea ( ! ,public ,heal? ,s]vice 
,act 7#db ,u4,s4,c4 #bfb71 z applicable1
 or o!rwise meet ! requirem5ts =        
approval "u ei!r su* section1 any       
product1 includ+ any device1 t is m>ket$
 or int5d$ = use ) su* a drug or        
biological product2 &  7,b7 does n      
include any drug or biological product t
 appe>s on ! drug %ortage li/ 9 effect  
"u section #ejf;,e ( ! ,f$]al ,food1    

,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4  
#cef;e71 unless--  7i7 ! drug or        
biological product has be5 on ! drug    
%ortage li/ 9 effect "u su* section     
#ejf;,e cont9u\sly = m ?an #f mon?s2 or 
7ii7 ! ,secret>y det]m9es t inclusion ( 
! drug or biological product z a cov]$  
product is likely to contribute to      
alleviat+ or prev5t+ a %ortage4  7#c7 ! 
t]m device has ! mean+ giv5 ! t]m 9     
section #bja ( ! ,f$]al ,food1 ,drug1 & 
,cosmetic ,act 7#ba ,u4,s4,c4 #cba72    
7#d7 ! t]m eligible product develop]    
means a p]son t seeks to develop a      
product = approval pursuant to an       
application = approval "u subsection    
7b77#b7 or 7j7 ( section #eje ( ! ,f$]al
 ,food1 ,drug1 & ,cosmetic ,act 7#ba    
,u4,s4,c4 #cee7 or = lic5s+ pursuant to 
an application "u section #cea7k7 ( !   
,public ,heal? ,s]vice ,act 7#db        
,u4,s4,c4 #bfb7k772  7#e7 ! t]m lic5se  
hold] means ! hold] ( an application    
approv$ "u subsection 7c7 or 7j7 (      
section #eje ( ! ,f$]al ,food1 ,drug1 & 

,cosmetic ,act 7#ba ,u4,s4,c4 #cee7 or !
 hold] ( a lic5se "u subsection 7a7 or  
7k7 ( section #cea ( ! ,public ,heal?   
,s]vice ,act 7#db ,u4,s4,c4 #bfb7 = a   
cov]$ product2  7#f7 ! t]m ,,rems means 
a risk evaluation & mitigation /rategy  
"u section #eje-a ( ! ,f$]al ,food1     
,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4  
#cee-a72  7#g7 ! t]m ,,rems ) ,,etasu   
means a ,,rems t conta9s elem5ts to     
assure safe use "u section #eje-a7;f7 ( 
! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 
7#ba ,u4,s4,c4 #cee-a7;f772  7#h7 ! t]m 
,secret>y means ! ,secret>y ( ,heal? &  
,human ,s]vices2  7#i7 ! t]m s+le1 %>$  
sy/em ( elem5ts to assure safe use means
 a s+le1 %>$ sy/em ( elem5ts to assure  
safe use "u section #eje-a7;f7 ( !      
,f$]al ,food1 ,drug1 & ,cosmetic ,act   
7#ba ,u4,s4,c4 #cee-a7;f772 &  7#aj7 !  
t]m suffici5t quantities means an am\nt 
( a cov]$ product t ! eligible product  
develop] det]m9es all[s x to-- 7,a7     
conduct te/+ to support an application  
"u--  7i7 subsection 7b77#b7 or 7j7 (   

section #eje ( ! ,f$]al ,food1 ,drug1 & 
,cosmetic ,act 7#ba ,u4,s4,c4 #cee72 or 
7ii7 section #cea7k7 ( ! ,public ,heal? 
,s]vice ,act 7#db ,u4,s4,c4 #bfb7k772 & 
7,b7 fulfill any regulatory requirem5ts 
relat+ to approval ( su* an application4
  7b7 ,civil action = failure ,to       
provide suffici5t quantities ( a cov]$  
product  7#a7 ,9 g5]al ,an eligible     
product develop] may br+ a civil action 
aga9/ ! lic5se hold] = a cov]$ product  
seek+ relief "u ?is subsection 9 an     
appropriate di/rict c\rt ( ! ,unit$     
,/ates alleg+ t ! lic5se hold] has      
decl9$ to provide suffici5t quantities (
 ! cov]$ product to ! eligible product  
develop] on comm]cially reasonable1     
m>ket-bas$ t]ms4  7#b7 ,elem5ts  7,a7 ,9
 g5]al ,to prevail 9 a civil action     
br\ght "u p>agraph 7#a71 an eligible    
product develop] %all prove1 by a       
prepond]ance ( ! evid5ce--  7i7 t-- 7,i7
 ! cov]$ product is n subject to a      
,,rems ) ,,etasu2 or  7,,ii7 if ! cov]$ 
product is subject to a ,,rems )        

,,etasu-- 7aa7 ! eligible product       
develop] has obta9$ a cov]$ product     
au?orization f ! ,secret>y 9 accordance 
) subp>agraph 7,b72 &  7bb7 ! eligible  
product develop] has provid$ a copy ( ! 
cov]$ product au?orization to ! lic5se  
hold]2  7ii7 t1 z ( ! date on :i* !     
civil action is fil$1 ! product develop]
 has n obta9$ suffici5t quantities ( !  
cov]$ product on comm]cially reasonable1
 m>ket-bas$ t]ms2  7iii7 t ! eligible   
product develop] has reque/$ to pur*ase 
suffici5t quantities ( ! cov]$ product f
 ! lic5se hold]2 &  7iv7 t ! lic5se     
hold] has n deliv]$ to ! eligible       
product develop] suffici5t quantities ( 
! cov]$ product on comm]cially          
reasonable1 m>ket-bas$ t]ms--  7,i7 = a 
cov]$ product t is n subject to a ,,rems
 ) ,,etasu1 by ! date t is #ca days aft]
 ! date on :i* ! lic5se hold] receiv$ ! 
reque/ = ! cov]$ product2 &  7,,ii7 = a 
cov]$ product t is subject to a ,,rems )
 ,,etasu1 by #ca days aft] ! lat] (--   
7aa7 ! date on :i* ! lic5se hold]       

receiv$ ! reque/ = ! cov]$ product2 or  
7bb7 ! date on :i* ! lic5se hold]       
receiv$ a copy ( ! cov]$ product        
au?orization issu$ by ! ,secret>y 9     
accordance ) subp>agraph 7,b74  7,b7    
,au?orization = cov]$ product subject to
 a ,,rems ) ,,etasu  7i7 ,reque/ ,an    
eligible product develop] may submit to 
! ,secret>y a writt5 reque/ = ! eligible
 product develop] to be au?oriz$ to     
obta9 suffici5t quantities ( an         
individual cov]$ product subject to a   
,,rems ) ,,etasu4  7ii7 ,au?orization ,n
 lat] ?an #abj days aft] ! date on :i* a
 reque/ "u clause 7i7 is receiv$1 !     
,secret>y %all1 by writt5 notice1       
au?orize ! eligible product develop] to 
obta9 suffici5t quantities ( an         
individual cov]$ product subject to a   
,,rems ) ,,etasu = purposes (--  7,i7   
developm5t & te/+ t does n involve human
 cl9ical trials1 if ! eligible product  
develop] has agre$ to comply ) any      
conditions ! ,secret>y det]m9es         
necess>y2 or  7,,ii7 developm5t & te/+ t

 involves human cl9ical trials1 if !    
eligible product develop] has-- 7aa7    
7,,aa7 submitt$ protocols1 in=m$ cons5t 
docum5ts1 & in=mational mat]ials = te/+ 
t include protections t provide safety  
protections comp>able to ^? provid$ by !
 ,,rems = ! cov]$ product2 or 7,,bb7    
o!rwise satisfi$ ! ,secret>y t su*      
protections w be provid$2 &  7bb7 met   
any o!r requirem5ts ! ,secret>y may     
e/abli%4  7iii7 ,notice ,a cov]$ product
 au?orization issu$ "u ?is subp>agraph  
%all /ate t ! provision ( ! cov]$       
product by ! lic5se hold] "u ! t]ms ( ! 
au?orization w n be a violation ( !     
,,rems = ! cov]$ product4  7#c7         
,affirmative def5se ,9 a civil action   
br\ght "u p>agraph 7#a71 x %all be an   
affirmative def5se1 on :i* ! def5dant   
has ! burd5 ( p]suasion by a            
prepond]ance ( ! evid5ce--  7,a7 t1 on !
 date on :i* ! eligible product develop]
 reque/$ to pur*ase suffici5t quantities
 ( ! cov]$ product f ! lic5se hold]--   
7i7 nei!r ! lic5se hold] nor any ( its  

ag5ts1 :olesal]s1 or di/ributors 0      
engag$ 9 ! manufactur+ or comm]cial     
m>ket+ ( ! cov]$ product2 &  7ii7 nei!r 
! lic5se hold] nor any ( its ag5ts1     
:olesal]s1 or di/ributors o!rwise _h    
access to inv5tory ( ! cov]$ product to 
supply to ! eligible product develop] on
 comm]cially reasonable1 m>ket-bas$     
t]ms2  7,b7 t-- 7i7 ! lic5se hold] sells
 ! cov]$ product ?r\gh ag5ts1           
di/ributors1 or :olesal]s2  7ii7 !      
lic5se hold] has plac$ no re/rictions1  
explicit or implicit1 on its ag5ts1     
di/ributors1 or :olesal]s to sell cov]$ 
products to eligible product develop]s2 
&  7iii7 ! cov]$ product c be pur*as$ by
 ! eligible product develop] 9 suffici5t
 quantities on comm]cially reasonable1  
m>ket-bas$ t]ms f ! ag5ts1 di/ributors1 
or :olesal]s ( ! lic5se hold]2 or  7,c7 
t ! lic5se hold] made an (f] to sell    
suffici5t quantities ( ! cov]$ product  
to ! eligible product develop] at       
comm]cially reasonable m>ket-bas$ t]ms--
  7i7 = a cov]$ product t is n subject  

to a ,,rems ) ,,etasu1 by ! date t is   
#ad days aft] ! date on :i* ! lic5se    
hold] receiv$ ! reque/ = ! cov]$        
product1 & ! eligible product develop]  
did n accept su* (f] by ! date t is #g  
days aft] ! date on :i* ! eligible      
product develop] receiv$ su* (f] f !    
lic5se hold]2 or  7ii7 = a cov]$ product
 t is subject to a ,,rems ) ,,etasu1 by 
! date t is #bj days aft] ! date on :i* 
! lic5se hold] receiv$ ! reque/ = !     
cov]$ product1 & ! eligible product     
develop] did n accept su* (f] by ! date 
t is #aj days aft] ! date on :i* !      
eligible product develop] receiv$ su*   
(f] f ! lic5se hold]4  7#d7 ,me?ods =   
transmission ( reque/s = cov]$ products 
,a writt5 reque/ = a cov]$ product1 (f] 
to sell a cov]$ product1 or acceptance (
 su* an (f] betwe5 ! eligible product   
develop] & ! lic5se hold] %all be made  
by--  7,a7 c]tifi$ or regi/]$ mail )    
return receipt reque/$2  7,b7 p]sonal   
deliv]y2 or  7,c7 electronic means4     
7#e7 ,rem$ies  7,a7 ,9 g5]al ,if an     

eligible product develop] prevails 9 a  
civil action br\ght "u p>agraph 7#a71 ! 
c\rt %all--  7i7 ord] ! lic5se hold] to 
provide to ! eligible product develop]  
)\t delay suffici5t quantities ( ! cov]$
 product on comm]cially reasonable1     
m>ket-bas$ t]ms2  7ii7 aw>d to !        
eligible product develop] reasonable    
attorney's fees & co/s ( ! civil action2
 &  7iii7 aw>d to ! eligible product    
develop] a monet>y am\nt suffici5t to   
det] ! lic5se hold] f fail+ to provide  
eligible product develop]s ) suffici5t  
quantities ( a cov]$ product on         
comm]cially reasonable1 m>ket-bas$ t]ms1
 if ! c\rt f9ds1 by a prepond]ance ( !  
evid5ce--  7,i7 t ! lic5se hold] delay$ 
provid+ suffici5t quantities ( ! cov]$  
product to ! eligible product develop]  
)\t a legitimate bus9ess ju/ification2  
or  7,,ii7 t ! lic5se hold] fail$ to    
comply ) an ord] issu$ "u clause 7i74   
7,b7 ,maximum monet>y am\nt ,a monet>y  
am\nt aw>d$ "u subp>agraph 7,a77iii7    
%all n be great] ?an ! rev5ue t ! lic5se

 hold] e>n$ on ! cov]$ product dur+ !   
p]iod--  7i7 beg9n+ on-- 7,i7 = a cov]$ 
product t is n subject to a ,,rems )    
,,etasu1 ! date t is #ca days aft] !    
date on :i* ! lic5se hold] receiv$ !    
reque/2 or  7,,ii7 = a cov]$ product t  
is subject to a ,,rems ) ,,etasu1 ! date
 t is #ca days aft] ! lat] (--  7aa7 !  
date on :i* ! lic5se hold] receiv$ !    
reque/2 or  7bb7 ! date on :i* ! lic5se 
hold] receiv$ a copy ( ! cov]$ product  
au?orization issu$ by ! ,secret>y 9     
accordance ) p>agraph 7#b77;,b72 &  7ii7
 end+ on ! date on :i* ! eligible       
product develop] receiv$ suffici5t      
quantities ( ! cov]$ product4  7,c7     
,avoidance ( delay ,! c\rt may issue an 
ord] "u subp>agraph 7,a77i7 be=e        
conduct+ fur!r proce$+s t may be        
necess>y to det]m9e :e!r ! eligible     
product develop] is entitl$ to an aw>d  
"u clause 7ii7 or 7iii7 ( subp>agraph   
7,a71 or ! am\nt ( any su* aw>d4  7c7   
,limitation ( liability ,a lic5se hold] 
= a cov]$ product %all n be liable = any

 claim "u ,f$]al1 ,/ate1 or local law   
aris+ out ( ! failure ( an eligible     
product develop] to foll[ adequate      
safegu>ds to assure safe use ( ! cov]$  
product dur+ developm5t or te/+         
activities describ$ 9 ?is section1      
includ+ transportation1 h&l+1 use1 or   
disposal ( ! cov]$ product by ! eligible
 product develop]4  7d7 ,no violation ( 
,,rems ,section #eje-a ( ! ,f$]al ,food1
 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 
#cee-a7 is am5d$ by add+ at ! end !     
foll[+ new subsection3  7l7 ,provision (
 samples n a violation ( /rategy ,!     
provision ( samples ( a cov]$ product to
 an eligible product develop] 7z ^? t]ms
 are def9$ 9 section #b7;a7 ( ! ,creat+ 
& ,re/or+ ,equal ,access to ,equival5t  
,samples ,act ( #bjai7 %all n be        
consid]$ a violation ( ! requirem5ts (  
any risk evaluation & mitigation /rategy
 t may be 9 place "u ?is section = su*  
drug4  4  7e7 ,rule ( con/ruction  7#a7 
,def9ition ,9 ?is subsection1 ! t]m     
antitru/ laws-- 7,a7 has ! mean+ giv5 ! 

t]m 9 subsection 7a7 ( ! fir/ section ( 
! ,clayton ,act 7#ae ,u4,s4,c4 #ab72 &  
7,b7 includes section #e ( ! ,f$]al     
,trade ,commission ,act 7#ae ,u4,s4,c4  
#de7 to ! ext5t t su* section applies to
 unfair me?ods ( competition4  7#b7     
,antitru/ laws ,no?+ 9 ?is section %all 
be con/ru$ to limit ! op]ation ( any    
provision ( ! antitru/ laws4  #c4 ,,rems
 approval process = subsequ5t fil]s     
,section #eje-a ( ! ,f$]al ,food1 ,drug1
 & ,cosmetic ,act 7#ba ,u4,s4,c4        
#cee-a71 z am5d$ by section #b1 is fur!r
 am5d$--  7#a7 9 subsection             
7g77#d77;,b7-- 7,a7 9 clause 7i7 by     
/rik+ or aft] ! semicolon2  7,b7 9      
clause 7ii7 by /rik+ ! p]iod at ! end & 
ins]t+ 2 or2 &  7,c7 by add+ at ! end ! 
foll[+3  7iii7 accommodate diff]5t1     
comp>able aspects ( ! elem5ts to assure 
safe use = a drug t is ! subject ( an   
application "u section #eje7;j71 & !    
applicable li/$ drug4  2  7#b7 9        
subsection 7i77#a71 by /rik+ subp>agraph
 7,c7 & ins]t+ ! foll[+3  7,c7 7i7      

,elem5ts to assure safe use1 if requir$ 
"u subsection 7f7 = ! li/$ drug1 :i*1   
subject to clause 7ii71 = a drug t is ! 
subject ( an application "u section     
#eje7;j7 may use--  7,i7 a s+le1 %>$    
sy/em ) ! li/$ drug "u subsection 7f72  
or  7,,ii7 a diff]5t1 comp>able aspect (
 ! elem5ts to assure safe use "u        
subsection 7f74  7ii7 ,! ,secret>y may  
require a drug t is ! subject ( an      
application "u section #eje7;j7 & ! li/$
 drug to use a s+le1 %>$ sy/em "u       
subsection 7f71 if ! ,secret>y det]m9es 
t no diff]5t1 comp>able aspect ( !      
elem5ts to assure safe use c\ld satisfy 
! requirem5ts ( subsection 7f74  2  7#c7
 9 subsection 7i71 by add+ at ! end !   
foll[+3  7#c7 ,%>$ ,,rems ,if !         
,secret>y approves1 9 accordance )      
p>agraph 7#a77;,c77i77,,ii71 a diff]5t1 
comp>able aspect ( ! elem5ts to assure  
safe use "u subsection 7f7 = a drug t is
 ! subject ( an abbreviat$ new drug     
application "u section #eje7;j71 !      
,secret>y may require t su* diff]5t     

comp>able aspect ( ! elem5ts to assure  
safe use c be us$ ) respect to any o!r  
drug t is ! subject ( an application "u 
section #eje7;j7 or #eje7;b7 t ref]5ces 
! same li/$ drug4  2 &  7#d7 by add+ at 
! end ! foll[+3  7m7 ,sep>ate ,,rems ,:5
 us$ 9 ?is section1 ! t]ms diff]5t1     
comp>able aspect ( ! elem5ts to assure  
safe use or diff]5t1 comp>able approv$  
risk evaluation & mitigation /rategies  
means a risk evaluation & mitigation    
/rategy = a drug t is ! subject ( an    
application "u section #eje7;j7 t uses  
diff]5t me?ods or op]ational means ?an !
 /rategy requir$ "u subsection 7a7 = !  
applicable li/$ drug1 or o!r application
 "u section #eje7;j7 ) ! same su* li/$  
drug1 b a*ieves ! same level ( safety z 
su* /rategy4  4  #d4 ,rule ( con/ruction
  7a7 ,9 g5]al ,no?+ 9 ?is ,act1 !      
am5dm5ts made by ?is ,act1 or 9 section 
#eje-a ( ! ,f$]al ,food1 ,drug1 &       
,cosmetic ,act 7#ba ,u4,s4,c4 #cee-a71  
%all be con/ru$ z--  7#a7 prohibit+ a   
lic5se hold] f provid+ an eligible      

product develop] access to a cov]$      
product 9 ! abs5ce ( an au?orization "u 
?is ,act2 or  7#b7 9 any way negat+ !   
applicability ( a ,,rems ) ,,etasu1 z   
o!rwise requir$ "u su* section #eje-a1 )
 respect to su* cov]$ product4  7b7     
,def9itions ,9 ?is section1 ! t]ms cov]$
 product1 eligible product develop]1    
lic5se hold]1 & ,,rems ) ,,etasu h !    
mean+s giv5 su* t]ms 9 section #c7;a74  
,may #aj1 #bjai ,report$ f ! ,committee 
on ,en]gy & ,comm]ce ) an am5dm5t ,may  
#aj1 #bjai ,report$ f ! ,committee on ! 
,judici>y2 committ$ to ! ,committee ( ! 
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