,i  #aah? ,,congress  #b;d ,session  ,h4
 ,r4 #hchj  ,,9 ,,! ,,h\se ,,(          
,,repres5tatives  ,may #ad1 #bjbd ,mr4  
,gre5 ( ,t5nessee 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$  ,a ,,bill  ,to crim9alize      
fraudul5t /atem5ts made ) respect to    
cl9ical vacc9e trials4  #a4 ,%ort title 
,?is ,act may be cit$ z ! ,vacc9es ,9   
,trial ,& ,liability ,act ( #bjbd or !  
,,vital ,act ( #bjbd4  #b4 ,m$ical      
rese>* company or sponsor  7a7 ,9 g5]al 
,*apt] #dg ( title #ah1 ,unit$ ,/ates   
,code1 is am5d$ by add+ at ! end !      
foll[+3  #ajda4 ,cl9ical vacc9e trial   
fraud ,:oev]1 be+ a m$ical rese>*       
company or sponsor1 makes a fraudul5t   
/atem5t to1 or conceals f1 any dep>tm5t 
or ag5cy ( ! ,unit$ ,/ates1 any mat]ial 
data collect$ f a cl9ical vacc9e trial1 

%all be f9$ "u ?is title1 imprison$ n m 
?an #e ye>s1 or bo?4  4  7b7 ,cl]ical   
am5dm5t ,! table ( sections = *apt] #dg 
( title #ah1 ,unit$ ,/ates ,code1 is    
am5d$ by add+ at ! end ! foll[+3  #ajda4
 ,cl9ical vacc9e trial fraud4  4  #c4   
,scope ( au?orization ,section #efd7;c7 
( ! ,f$]al ,food1 ,drug1 & ,cosmetic    
,act 7#ba ,u4,s4,c4 #cfj;bbb-#c7;c77 is 
am5d$-- 7#a7 9 p>agraph 7#d71 by /rik+ &
  7#b7 by r$esignat+ p>agraph 7#e7 z    
p>agraph 7#f72 &  7#c7 by ins]t+ aft]   
p>agraph 7#d7 ! foll[+3  7#e7 !         
au?orization is bas$ on a c]tification  
by a m$ical rese>* company or sponsor t 
no fraudul5t mat]ial /atem5ts 7 made1 & 
no mat]ial in=mation 0 conceal$1 )      
respect to ! circum/ances describ$ "u   
subsection 7b77#a7 or ! crit]ia "u ?is  
subsection2 &  4  #d4 ,revision &       
revocation ,section #efd7;g77#b7 ( !    
,f$]al ,food1 ,drug1 & ,cosmetic ,act   
7#ba ,u4,s4,c4 #cfj;bbb-#c7;g77#b77 is  
am5d$--  7#a7 9 subp>agraph 7,b71 by    
/rik+ or at ! end2  7#b7 by r$esignat+  

subp>agraph 7,c7 z subp>agraph 7,d72 &  
7#c7 by ins]t+ aft] subp>agraph 7,b7 !  
foll[+3  7,c7 ! ,secret>y det]m9es t    
fraudul5t mat]ial /atem5ts 7 made1 or   
mat]ial in=mation 0 conceal$1 ) respect 
to ! circum/ances describ$ "u subsection
 7b77#a7 or ! crit]ia "u subsection 7c72
 or  4  #e4 ,exception to limitation on 
liability ,section #b7;b77#a7 ( !       
,trickett ,w5dl]1 ,frank ,mongiello1    
,jordan ,mc,linn1 & ,mat!w ,bell9a ,"r  
to ,try ,act ( #bjag 7#ba ,u4,s4,c4     
#cfj;bbb-#j;a note7 is am5d$-- 7#a7 9   
subp>agraph 7,a71 by ins]t+ 1 unless a  
fraudul5t mat]ial /atem5t 0 made1 or    
mat]ial in=mation 0 conceal$1 ) respect 
to data collect$ f a cl9ical trial ( !  
inve/igational drug be=e ! semicolon2 & 
7#b7 9 subp>agraph 7,b71 by ins]t+ 1    
includ+ a fraudul5t mat]ial /atem5t     
made1 or mat]ial in=mation conceal$1 )  
respect to data collect$ f a cl9ical    
trial ( ! inve/igational drug be=e !    
p]iod4  #f4 ,exception to t>get$        
liability protections = p&emic &        

epidemic products ,section #cai;,f-#c ( 
! ,public ,heal? ,s]vice ,act 7#db      
,u4,s4,c4 #bdg;d-#f;d7c77 is am5d$--    
7#a7 9 subsection 7c7-- 7,a7 9 p>agraph 
7#a77;,a7--  7i7 by r$esignat+ clauses  
7i71 7ii71 & 7iii7 z subclauses 7,i71   
7,,ii71 & 7,,iii71 respectively2  7ii7  
by mov+ subclauses 7,i71 7,,ii71 &      
7,,iii71 z r$esignat$1 #b ems to ! "r2  
7iii7 by /rik+ ! p]iod at ! end (       
subclause 7,,iii71 z r$esignat$2  7iv7  
by /rik+ subsection 7d71 d5ote & ins]t+ 
! foll[+3  subsection 7d7-- 7i7 d5ote  2
 &  7v7 by add+ at ! end ! foll[+3  7ii7
 includes--  7,i7 mak+ a fraudul5t      
mat]ial /atem5t ) respect to data       
collect$ f a cl9ical trial2 or  7,,ii7  
conceal+ mat]ial in=mation ) respect to 
data collect$ f a cl9ical trial4  2 &   
7,b7 9 p>agraph 7#e77;,a7-- 7i7 9 !     
matt] prec$+ clause 7i71 by /rik+       
subsection 7d7 if-- & ins]t+ subsection 
7d7--2  7ii7 9 clause 7i7-- 7,i7 by     
ins]t+ if be=e nei!r2 &  7,,ii7 by /rik+
 or at ! end2  7iii7 9 clause 7ii7--    

7,i7 by ins]t+ if be=e su* an en=cem5t2 
&  7,,ii7 by /rik+ ! p]iod at ! end &   
ins]t+ 2 &2 &  7iv7 by add+ at ! end !  
foll[+3  7iii7 unless ! ,secret>y       
det]m9es1 aft] notice & opportunity = a 
he>+1 t a fraudul5t mat]ial /atem5t 0   
made1 or mat]ial in=mation 0 conceal$1  
by a cov]$ p]son ) respect to data      
collect$ f a cl9ical trial ( a cov]$    
c\nt]measure4  2  7#b7 9 subsection 7d7 
by add+ at ! end ! foll[+3  7#aa7 ,aw>d 
( damages ,not)/&+ any o!r provision (  
law1 ! am\nt ( an aw>d ( damages made to
 a pla9tiff may n be r$uc$ because ( any
 o!r aw>d = damages ! pla9tiff may      
receive z a result ( su* claim4  2 &    
7#c7 subsection 7e71 by /rik+ p>agraph  
7#g74  #g4 ,national ,vacc9e ,injury    
,comp5sation ,program ,section #babb ( !
 ,public ,heal? ,s]vice ,act 7#db       
,u4,s4,c4 #cjj;aa-#bb7 is am5d$ by add+ 
at ! end ! foll[+3  7f7 ,liability  7#a7
 ,fraudul5t mat]ial /atem5t ,no civil   
action aga9/ a vacc9e manufactur] or    
vacc9e sponsor %all be b>r$ "u ?is "p if

 ! ,secret>y det]m9es1 aft] notice &    
opportunity = a he>+1 t a fraudul5t     
mat]ial /atem5t 0 made1 or mat]ial      
in=mation 0 conceal$1 by a vacc9e       
manufactur] ) respect to data collect$ f
 a cl9ical trial ( a vacc9e4  7#b7 ,aw>d
 ( damages  7,a7 ,9 g5]al ,not)/&+ any  
o!r provision ( law1 an pla9tiff br++ a 
claim pursuant to p>agraph 7#a7 may--   
7i7 seek comp5sation "u ! program       
e/abli%$ "u ?is "p2 &  7ii7 concurr5tly 
br+ an action ) respect to su* claim 9  
any appropriate ,unit$ ,/ates di/rict   
c\rt4  7,b7 ,aw>d ( damages ,not)/&+ any
 o!r provision ( law1 ! am\nt ( an aw>d 
( damages made to a pla9tiff = a claim  
pursuant to p>agraph 7#a7 may n be r$uc$
 on ! basis ( any o!r damages ! pla9tiff
 may receive z a result ( su* claim4    
7#c7 ,applicability ) respect to        
,,covid-#ai vacc9e ,not)/&+ any o!r     
provision ( law1 a civil action aga9/ a 
vacc9e manufactur] pursuant to p>agraph 
7#a7 ) respect to a vacc9e relat$ to    
,,covid-#ai may be made at any "t4  7#d7

 ,,covid-#ai def9ition ,9 ?is section1 !
 t]m ,,covid-#ai means ! coronavirus    
disease caus$ by ! sev]e acute          
respiratory syndrome coronavirus #b or !
 ,,s>s-,co,v-#b4 ,?is t]m also relates  
to any & all v>iations ( t virus ( :i*  
!re is no t]m9ation date = ?is t]m4  #h4
 ,liability he>+  7a7 ,fraudul5t mat]ial
 or /atem5ts ,9 ! case t ! ,secret>y (  
,heal? & ,human ,s]vices det]m9es t a   
vacc9e manufactur] or vacc9e sponsor has
 made fraudul5t mat]ial or /atem5ts or  
conceal$ mat]ial in=mation ) respect to 
a situation describ$ 9 ?is ,act1 or an  
am5dm5t made by ?is ,act1 ! ,secret>y   
%all & provide su* manufactur] or       
sponsor #cj days to refute a det]m9ation
 made 9 a he>+ describ$ 9 subsection    
7b74  7b7 ,he>+  7#a7 ,9 g5]al ,!       
,secret>y %all det]m9e a date1 "t1 &    
=mat = a he>+ "u ?is subsection1 includ+
 a requirem5t t ! vacc9e manufactur] or 
vacc9e sponsor provide any reque/$      
docum5t to ! ,secret>y n m ?an five days
 be=e ! he>+4  7#b7 ,=mat ,! =mat ( a   

he>+ "u p>agraph 7#a7 %all be det]m9$ by
 ! ,secret>y4  7#c7 ,publication ,any   
writt5 or v]bal te/imony submitt$ by !  
vacc9e manufactur] or vacc9e sponsor at 
! he>+ "u p>agraph 7#a7 %all be publi%$ 
on ! int]net website ( ! ,secret>y (    
,heal? & ,human ,s]vices4  7c7 ,does n  
provide in=mation ,9 ! case t ! vacc9e  
manufactur] or vacc9e sponsor does n    
respond to ! ,secret>y 9 accordance )   
?is section1 an initial det]m9ation (   
fraud %all be ma9ta9$ & %all h ! full   
=ce & effect ( ?is ,act4