,i  #aai? ,,congress  #a/ ,session  ,h4 
,r4 #bcjj  ,,9 ,,! ,,h\se ,,(           
,,repres5tatives  ,m>* #bd1 #bjbe,mrs4  
,h>%b>g] 7= h]self & ,mr4 ,s*neid]7     
introduc$ ! foll[+ bill2 :i* 0 ref]r$ to
 ! ,committee on ,en]gy & ,comm]ce  ,a  
,,bill  ,to ensure national uni=mity )  
respect to c]ta9 requirem5ts relat+ to  
pret]m infant =mula1 & = o!r purposes4  
#a4 ,pret]m infant =mula  7a7 ,/udy     
7#a7 ,9 g5]al ,! ,secret>y ( ,heal? &   
,human ,s]vices1 act+ ?r\gh !           
,commission] ( ,food & ,drugs1 %all     
/udy-- 7,a7 ! availability ( pret]m     
infant =mula 9 ! ,unit$ ,/ates2  7,b7   
,f$]al & ,/ate laws1 regulations1 ord]s1
 & requirem5ts1 includ+ "u ,/ate common 
law1 t relate to pret]m infant =mula1   
includ+ ) respect to-- 7i7 ! design1    
developm5t1 cl9ical te/+ or             
inve/igation1 =mulation1 manufacture1   
di/ribution1 sale1 donation1 pur*ase1   
m>ket+1 promotion1 packag+1 label+1     
lic5s+1 & use ( pret]m infant =mula2 or 
7ii7 any aspect ( ! safety ( pret]m     

infant =mula2  7,c7 :e!r ! ,f$]al ,food1
 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 
#cja et seq47 %\ld be am5d$ to require a
 manufactur] ( pret]m infant =mula to   
obta9 prem>ket approval = su* =mula f ! 
,food & ,drug ,adm9i/ration2 &  7,d7 if 
! ,secret>y recomm5ds su* prem>ket      
approval1 a process & correspond+       
requirem5ts = su* prem>ket approval4    
7#b7 ,recomm5dations ,n lat] ?an two    
ye>s aft] ! date ( enactm5t ( ?is ,act1 
! ,secret>y ( ,heal? & ,human ,s]vices1 
act+ ?r\gh ! ,commission] ( ,food &     
,drugs1 %all submit to ! ,congress a    
report on ! results ( ! /udy "u p>agraph
 7#a74  7b7 ,tempor>y preemption  7#a7  
,p]iod ( applicability ,?is subsection  
applies only dur+ ! p]iod-- 7,a7 beg9n+ 
on ! date ( enactm5t ( ?is ,act2 &  7,b7
 end+ on ! date t is two ye>s aft] !    
date ( enactm5t ( ?is ,act4  7#b7       
,preemption ,except z provid$ 9 p>agraph
 7#c71 no ,/ate or political subdivision
 ( a ,/ate may e/abli%1 implem5t1 or    
en=ce ) respect to pret]m infant =mula  

any requirem5t1 includ+ "u any ,/ate    
/atute1 regulation1 ord]1 or common     
law-- 7,a7 t is diff]5t f1 or 9 addition
 to1 any requirem5t applicable to pret]m
 infant =mula "u ! ,f$]al ,food1 ,drug1 
& ,cosmetic ,act 7#ba ,u4,s4,c4 #cja et 
seq471 ! ,poison ,prev5tion ,packag+    
,act ( #aigj 7#ae ,u4,s4,c4 #adga et    
seq471 or ! ,fair ,packag+ & ,label+    
,act 7#ae ,u4,s4,c4 #adea et seq472 &   
7,b7 t relates to pret]m infant =mula1  
includ+-- 7i7 ! design1 developm5t1     
cl9ical te/+ or inve/igation1 =mulation1
 manufacture1 di/ribution1 sale1        
donation1 pur*ase1 m>ket+1 promotion1   
packag+1 label+1 lic5s+1 & use ( pret]m 
infant =mula2 &  7ii7 any aspect ( !    
safety ( pret]m infant =mula4  7#c7     
,exception = civil & crim9al actions =  
willful misconduct  7,a7 ,exception     
,p>agraph 7#b7 does n preempt civil or  
crim9al actions bas$ on a requirem5t    
describ$ 9 p>agraph 7#b7 to ! ext5t su* 
actions are aga9/ a manufactur] =       
willful misconduct 9 ! manufactur+ or   

production ( pret]m infant =mula t caus$
 dea? or s]i\s physical injury4  7,b7   
,removal ,9 ! case ( a civil action     
br\ght 9 a ,/ate c\rt aga9/ a           
manufactur]1 if t manufactur] alleges t 
! law "u :i* ! action is br\ght is      
preempt$ by p>agraph 7#b71 su* action   
may be remov$ by ! manufactur] to !     
di/rict c\rt ( ! ,unit$ ,/ates = !      
di/rict & division embrac+ ! place :]e9 
! civil action is p5d+4 ,?is subp>agraph
 applies to any action p5d+ be=e1 on1 or
 aft] ! date ( enactm5t ( ?is ,act1     
except to ! ext5t t !re is a f9al       
judgm5t f :i* no appeal may be tak5 & no
 fur!r review may be s\ght f a c\rt (   
la/ resort1 includ+ ! ,supreme ,c\rt ( !
 ,unit$ ,/ates4  7,c7 ,burd5 ( pro( ,9  
det]m9+ :e!r ! exception 9 subp>agraph  
7,a7 applies1 ! pla9tiff %all h ! burd5 
( prov+ t ! crit]ia describ$ 9          
subp>agraph 7,a7 are met by cle> &      
conv9c+ evid5ce4  7#d7 ,dismissal ( p5d+
 actions ,a civil or crim9al action t is
 p5d+ z ( ! date ( enactm5t ( ?is ,act  

%all be dismiss$ to ! ext5t su* action  
seeks to implem5t or en=ce a requirem5t 
t is preempt$ by p>agraph 7#b74  7c7    
,def9itions ,9 ?is section3 7#a7 ,! t]m 
infant =mula has ! mean+ giv5 to su* t]m
 9 section #bja7z7 ( ! ,f$]al ,food1    
,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4  
#cba7z774  7#b7 ,! t]m manufactur]--    
7,a7 means a p]son :o-- 7i7 prep>es1    
recon/itutes1 or o!rwise *anges !       
physical or *emical *>act]i/ics ( a     
pret]m infant =mula2 or  7ii7 packages  
or labels a pret]m infant =mula 9 a     
conta9] = di/ribution2 &  7,b7 does n   
include a p]son tak+ actions describ$ 9 
subp>agraph 7,a7 exclusively = an infant
 "u su* p]son's direct c>e4  7#c7 ,! t]m
 pret]m infant =mula means any infant   
=mula t is exempt "u section            
#dab7;h77#a7 ( ! ,f$]al ,food ,drug1 &  
,cosmetic ,act 7#ba ,u4,s4,c4 #cej;a7h77
 & int5d$ to be adm9i/]$ to-- 7,a7 an   
infant born be=e #cg weeks ( ge/ation2  
or  7,b7 a l[-bir?-weight infant4  7#d7 
,! t]m willful misconduct means1 except 

z su* t]m is fur!r re/rict$ pursuant to 
subp>agraph 7,b71 an act or omission t  
is tak5-- 7,a7 int5tionally to a*ieve a 
wrongful purpose2  7,b7 kn[+ly )\t legal
 or factual ju/ification2 &  7,c7 9     
disreg>d ( a kn[n or obvi\s risk t is s 
great z to make x highly probable t !   
h>m w outweigh ! b5efit4