,i  #aag? ,,congress  #a/ ,session  ,h4 
,r4 #cgje  ,,9 ,,! ,,h\se ,,(           
,,repres5tatives  ,june #d1 #bjba,mr4   
,griffi? introduc$ ! foll[+ bill2 :i* 0 
ref]r$ to ! ,committee on ,en]gy &      
,comm]ce  ,a ,,bill  ,to am5d ! ,f$]al  
,food1 ,drug1 & ,cosmetic ,act to       
include a safe h>bor = communication (  
in=mation ) respect to a vacc9e au?oriz$
 = em]g5cy use "u su* ,act t is provid$ 
or di/ribut$ to a heal? c>e provid]1 & =
 o!r purposes4  #a4 ,safe h>bor =       
communications ab\t vacc9es au?oriz$ =  
em]g5cy use  7a7 ,9 g5]al ,! ,f$]al     
,food1 ,drug1 & ,cosmetic ,act is am5d$ 
by ins]t+ aft] section #ejb 7#ba        
,u4,s4,c4 #ceb7 ! foll[+3  #ejb;,a4     
,safe h>bor = communications ab\t       
vacc9es au?oriz$ = em]g5cy use  7a7 ,9  
g5]al ,! communication ( in=mation      
7?r\gh writt5 or oral means71 describ$ 9
 subsection 7b71 ) respect to ! use ( a 
vacc9e au?oriz$ = em]g5cy use "u section
 #efd provid$ or di/ribut$ to a cov]$   
heal? c>e entity %all n be a basis =    

treat+ su* vacc9e z1 or be treat$ z     
evid5ce t su* vacc9e is-- 7#a7 misbr&$  
"u subsection 7a7 or 7f7 ( section #ejb2
 or  7#b7 9 violation ( section #eje or 
#efd ( ?is ,act or subsection 7a7 or 7k7
 ( section #cea7;a77#a7 ( ! ,public     
,heal? ,s]vice ,act1 z applicable4  7b7 
,in=mation describ$ ,in=mation describ$ 
9 ?is subsection is any in=mation relat+
 to a use ( a vacc9e au?oriz$ = em]g5cy 
use "u section #efd )9 ! scope ( t      
au?orization t-- 7#a7 is nei!r false nor
 mislead+1 :5 measur$ objectively aga9/ 
! in=mation available at ! "t ! /atem5t 
is made2  7#b7 is accompani$1 z requir$1
 by an appropriate disclaim]1 includ+-- 
7,a7 a /atem5t id5tify+ any diff]5ces   
betwe5 ! in=mation & any au?oriz$ label+
 ( ! vacc9e2  7,b7 a /atem5t id5tify+   
contradictory evid5ce2 &  7,c7 su* o!r  
in=mation z may be requir$ by           
regulation2 &  7#c7 is bas$ on compet5t 
& reliable sci5tific evid5ce1 z describ$
 9 subsection 7e74  7c7 ,cov]age n      
exclud$ ,! di/ribution ( in=mation t    

o!rwise meets ! requirem5ts ( ?is       
section %all n fail to meet !           
requirem5ts ( subsection 7a7 because !  
manufactur] or di/ributor ( ! vacc9e    
ab\t :i* in=mation is be+ di/ribut$     
has-- 7#a7 k t su* vacc9e is be+ us$ by 
pati5ts or heal? c>e practition]s 9 a   
mann] n describ$ 9 any au?oriz$ label+ (
 ! vacc9e1 z applicable2 or  7#b7       
objective or subjective int5t t su*     
vacc9e be us$ 9 a mann] inconsi/5t ) any
 label+1 z applicable1 ( su* vacc9e4    
7d7 ,rule ( con/ruction ,no?+ 9 ?is     
section %all be con/ru$-- 7#a7 to limit 
communication to :i* ?is section does n 
specifically apply2 or  7#b7 to alt] or 
exp& ! au?ority ( ! ,secret>y to en=ce !
 provisions ( ?is ,act ( section #cea ( 
! ,public ,heal? ,s]vice ,act1 except ) 
respect to ! communication ( in=mation  
to :i* ?is section specifically applies4
  7e7 ,def9itions ,9 ?is section3 7#a7  
,compet5t & reliable sci5tific evid5ce  
7,a7 ,9 g5]al ,9 ?is section1 ! t]m     
compet5t & reliable sci5tific evid5ce   

means evid5ce e/abli%$ ?r\gh sci5tific  
me?ods t are widely accept$ by exp]ts 9 
! relevant field & foll[$ pursuant to a 
cle> & well-describ$ protocol1 z        
sci5tifically appropriate1 reg>dless (  
:e!r su* evid5ce is support$ by #b      
adequate & well-controll$ cl9ical       
/udies4  7,b7 ,inclusions ,su* t]m may  
include in=mation-- 7i7 d]iv$ f cl9ical 
trials1 obs]vational /udies1 cl9ical    
/udies or b5* te/s t describe p]=mance1 
database reviews1 regi/ries1 pati5t     
utilization projections1 & model+       
te*niques1 & ! data1 inputs1 & compon5ts
 ( su* in=mation2  7ii7 ab\t ! effects (
 a vacc9e 9 subgr\ps def9$ by           
demographic or o!r v>iables1 includ+    
gr\ps def9$ by race1 sex1 risk factors1 
or o!r v>iables1 su* z g5omic features  
or disease sev]ity2  7iii7 relat$ to !  
au?orization = em]g5cy use "u section   
#efd1 z applicable2 &  7iv7 relat+ to ! 
safety1 effectiv5ess1 or b5efit ( a use 
or treatm5t t is au?oriz$ = em]g5cy use 
"u section #efd = a vacc9e1 includ+     

in=mation reg>d+-- 7,i7 heal? outcomes1 
pati5t or c>egiv] exp]i5ce1 or o!r      
quality metrics2 &  7,,ii7 ! comp>ative 
effectiv5ess ( a vacc9e relative to o!r 
products1 o!r heal? c>e int]v5tions1    
program & quality improvem5t            
int]v5tions1 or no int]v5tion4  7#b7    
,cov]$ heal? c>e entity ,! t]m cov]$    
heal? c>e entity means a heal? c>e      
provid]1 heal? c>e in/itution1 payor1   
=mul>y committee1 or o!r simil> entity  
c>ry+ out responsibilities = mak+ drug  
cov]age1 reimbursem5t1 or usage         
decisions on a population basis4  4