,i  #aah? ,,congress  #a/ ,session  ,h4 
,r4 #eggc  ,,9 ,,! ,,h\se ,,(           
,,repres5tatives  ,septemb] #bg1        
#bjbc,mr4 ,posey introduc$ ! foll[+     
bill2 :i* 0 ref]r$ to ! ,committee on   
,en]gy & ,comm]ce  ,a ,,bill  ,to am5d !
 ,public ,heal? ,s]vice ,act to remove  
c]ta9 liability protections = c]ta9     
biological products & o!r drugs if !    
sponsor !re( fails to disclose to !     
public all non-exempt data )9 !         
biological product file or drug         
application1 & = o!r purposes4  #a4     
,%ort title ,?is ,act may be cit$ z !   
,consum] ,vacc9e ,safety & ,protection  
,act ( #bjbc4  #b4 ,disclosure (        
non-exempt data requir$ = c]ta9         
biological products & o!r drugs ,section
 #cai;,f-#c ( ! ,public ,heal? ,s]vice  
,act 7#db ,u4,s4,c4 #bdg;d-#f;b7 is     
am5d$ by add+ at ! end ! foll[+3  7j7   
,disclosure ( non-,exempt data requir$  
7#a7 ,cov]$ products ,9 ?is subsection1 
! t]m cov]$ product means a cov]$       
c\nt]measure t-- 7,a7 is a biological   

product or o!r drug2 &  7,b7 is au?oriz$
 = em]g5cy use "u section #efd ( !      
,f$]al ,food1 ,drug1 & ,cosmetic ,act on
 or aft] ! date ( enactm5t ( ! ,consum] 
,vacc9e ,safety & ,protection ,act (    
#bjbc1 irrespective ( :e!r ! biological 
product or drug lat] receives approval  
or lic5sure "u section #eje ( ! ,f$]al  
,food1 ,drug1 & ,cosmetic ,act or       
section #cea ( ?is ,act4  7#b7          
,disclosure by sponsors  7,a7 ,9 g5]al  
,subject to subp>agraph 7,c71 ! sponsor 
( a cov]$ product %all disclose to !    
public1 9 an easily accessible location 
on ! website ( ! sponsor ( ! cov]$      
product-- 7i7 9 ! case ( a biological   
product1 all data & in=mation available 
= public disclosure "u section          
#fja4ea7;e7 ( title #ba1 ,code ( ,f$]al 
,regulations 7or successor regulations72
 &  7ii7 9 ! case ( ano!r drug1 all data
 & in=mation available = public         
disclosure "u section #cad4dcj ( title  
#ba1 ,code ( ,f$]al ,regulations 7or    
successor regulations74  7,b7 ,tim+ ,!  

sponsor ( a cov]$ product %all1 )       
respect to any data or in=mation requir$
 to be disclos$ by subp>agraph 7,a71    
make ! disclosure n lat] ?an #aj days   
aft] ! lat] (-- 7i7 ! date on :i* !     
,food & ,drug ,adm9i/ration au?orizes ! 
em]g5cy use ( ! cov]$ product "u section
 #efd ( ! ,f$]al ,food1 ,drug1 &        
,cosmetic ,act2 &  7ii7 ! date on :i* ! 
data or in=mation becomes available to !
 sponsor4  7,c7 ,exceptions ,!          
disclosure requirem5t 9 subp>agraph 7,a7
 does n apply ) respect to-- 7i7 a trade
 secret or confid5tial comm]cial or     
f9ancial in=mation z def9$ 9 section    
#bj4fa ( title #ba1 ,code ( ,f$]al      
,regulations 7or successor regulations72
 or  7ii7 p]sonally id5tifiable         
in=mation4  7#c7 ,disclosure by ,,hhs   
7,a7 ,9 g5]al ,subject to subp>agraph   
7,b71 ! ,secret>y %all-- 7i7 n lat] ?an 
#aj days aft] ! ,food & ,drug           
,adm9i/ration au?orizes ! em]g5cy use ( 
a cov]$ product "u section #efd ( !     
,f$]al ,food1 ,drug1 & ,cosmetic ,act or

 approves or lic5ses a cov]$ product "u 
section #eje ( su* ,act or section #cea 
( ?is ,act1 disclose to ! public1 9 an  
easily accessible location on ! website 
( ! ,dep>tm5t ( ,heal? & ,human         
,s]vices1 all data & in=mation requir$  
by p>agraph 7#b7 to be disclos$ by !    
sponsor ( ! product2 &  7ii7 n lat] ?an 
#cj days aft] receiv+ any additional su*
 data & in=mation1 s disclose su* data &
 in=mation4  7,b7 ,exception ,!         
disclosure requirem5t 9 subp>agraph 7,a7
 does n apply ) respect to data &       
in=mation exempt$ f disclosure by       
p>agraph 7#b77;,c74  7#d7 ,en=cem5t     
aga9/ sponsors = failure to disclose    
7,a7 ,exclusion f def9ition ( cov]$     
c\nt]measure ,not)/&+ subsection        
7i77#a71 a cov]$ product is deem$ to be 
exclud$ f ! def9ition ( a cov]$         
c\nt]measure = purposes ( ! provisions (
 ?is section 7o!r ?an ?is subsection7 & 
section #cai;,f-#d if-- 7i7 ! cov]$     
product is adm9i/]$ on or aft] ! date ( 
enactm5t ( ! ,consum] ,vacc9e ,safety & 

,protection ,act ( #bjbc2 &  7ii7 !     
sponsor ( ! cov]$ product is det]m9$ by 
! ,secret>y to h kn[+ly fail$ to make a 
disclosure requir$ by p>agraph 7#b7 )   
respect to ! cov]$ product4  7,b7       
,ineligibility = ,,fda aw>ds1 funds1 or 
o!r b5efits ,if ! sponsor ( a cov]$     
product is det]m9$ by ! ,secret>y to h  
kn[+ly fail$ to make a disclosure       
requir$ by p>agraph 7#b7 ) respect to ! 
cov]$ product1 su* sponsor %all be      
treat$ z ineligible = ! aw>d ( any      
grant1 coop]ative agreem5t1 or loan or =
 any new grant ( em]g5cy use            
au?orization1 exp&$ access1 or approval 
or lic5sure ( any product "u section    
#cea ( ?is ,act or any provision ( !    
,f$]al ,food1 ,drug1 & ,cosmetic ,act s 
long z su* sponsor cont9ues to be 9     
violation ( su* requirem5t4  7#e7       
,en=cem5t aga9/ ,,hhs = failure to      
disclose ,a p>ty injur$ by a cov]$      
product ) respect to :i* ! ,secret>y    
fail$ to c>ry out ! ,secret>y's duties  
"u p>agraph 7#c7 may br+ an action 9 !  

appropriate di/rict c\rt ( ! ,unit$     
,/ates = appropriate relief1 includ+    
damages4  4