,i  #aac? ,,congress  #a/ ,session  ,h4 
,r4 #ageg  ,,9 ,,! ,,h\se ,,(           
,,repres5tatives  ,april #be1 #bjac ,mr4
 ,posey 7= himself & ,mrs4 ,c>olyn ,b4  
,maloney ( ,new ,york7 introduc$ !      
foll[+ bill2 :i* 0 ref]r$ to !          
,committee on ,en]gy & ,comm]ce  ,a     
,,bill  ,to direct ! ,secret>y ( ,heal? 
& ,human ,s]vices to conduct or support 
a compreh5sive /udy comp>+ total heal?  
outcomes1 includ+ risk ( autism1 9      
vacc9at$ populations 9 ! ,unit$ ,/ates )
 su* outcomes 9 unvacc9at$ populations 9
 ! ,unit$ ,/ates1 & = o!r purposes4  #a4
 ,%ort title ,?is ,act may be cit$ z !  
,vacc9e ,safety ,/udy ,act4  #b4 ,f9d+s 
,! ,congress f9ds z foll[s3  7#a7       
,secur+ ! heal? ( ! ,nation's *ildr5 is 
our mo/ important conc]n z p>5ts &      
/ew>ds ( ! ,nation's future4  7#b7 ,!   
,nation's vacc9e program has greatly    
r$uc$ human suff]+ f infecti\s disease  
by prev5t+ & r$uc+ ! outbreak (         
vacc9e-prev5table diseases4  7#c7 ,total
 heal? outcomes are ! be/ measure ( !   

success ( any public heal? ef=t1 includ+
 security f bo? *ronic & infecti\s      
disease4  7#d7 ,*ildhood immunizations  
are an important tool 9 protect+ *ildr5 
f infecti\s disease4  7#e7 ,! numb] (   
immunizations adm9i/]$ to infants1      
pregnant wom51 *ildr51 te5ag]s1 & adults
 has gr[n dramatically ov] rec5t ye>s4  
7#f7 ,! incid5ce ( *ronic1 unexpla9$    
diseases su* z autism1 le>n+            
disabilities1 & o!r neurological        
disord]s appe>s to h increas$           
dramatically 9 rec5t ye>s4  7#g7        
,individual vacc9es are te/$ = safety1 b
 little safety te/+ has be5 conduct$ =  
int]action effects ( multiple vacc9es4  
7#h7 ,! /rategy ( aggressive1 e>ly      
*ildhood immunization aga9/ a l>ge numb]
 ( infecti\s diseases has nev] be5 te/$ 
9 its entirety aga9/ alt]native         
/rategies1 ei!r = safety or = total     
heal? outcomes4  7#i7 ,*ildhood         
immunizations are ! only heal?          
int]v5tions t are requir$ by ,/ates (   
all citiz5s 9 ord] to p>ticipate 9 civic

 society4  7#aj7 ,public confid5ce 9 !  
managem5t ( public heal? c only be      
ma9ta9$ if ^! ,/ate gov]nm5t-m&at$1 mass
 vacc9ation programs--  7,a7 are te/$   
rigor\sly & 9 _! entirety aga9/ all     
reasonable safety conc]ns2 &  7,b7 are  
v]ifi$ 9 _! entirety to produce sup]ior 
heal? outcomes4  7#aa7 ,!re are num]\s  
,unit$ ,/ates populations 9 :i* a       
practice ( no vacc9ation is foll[$ & :i*
 !re=e provide a natural comp>ison gr\p 
= comp>+ total heal? outcomes4  7#ab7   
,no comp>ative /udy ( su* heal? outcomes
 has ev] be5 conduct$4  7#ac7 ,giv5 ris+
 conc]n ov] ! high rates ( *ildhood     
neurodevelopm5tal disord]s su* z autism 
& o!r *ronic conditions1 ! ne$ = su*    
/udies is becom+ urg5t4  #c4 ,/udy on   
heal? outcomes 9 vacc9at$ & unvacc9at$  
,am]ican populations  7a7 ,9 g5]al ,!   
,secret>y ( ,heal? & ,human ,s]vices 79 
?is ,act ref]r$ to z ! ,secret>y71 act+ 
?r\gh ! ,director ( ! ,national         
,in/itutes ( ,heal?1 %all conduct or    
support a compreh5sive /udy--  7#a7 to  

comp>e total heal? outcomes1 includ+ !  
incid5ce & risk ( autism1 9 vacc9at$    
populations 9 ! ,unit$ ,/ates ) su*     
outcomes 9 unvacc9at$ populations 9 !   
,unit$ ,/ates2 &  7#b7 to det]m9e :e!r  
exposure to vacc9es or vacc9e compon5ts 
is associat$ ) autism spectrum disord]s1
 *ronic conditions1 or o!r neurological 
conditions4  7b7 ,rule ( con/ruction    
,no?+ 9 ?is ,act %all be con/ru$ to     
au?orize ! conduct or support ( any /udy
 9 :i* an individual or population is   
enc\rag$ or inc5tiviz$ to rema9         
unvacc9at$4  7c7 ,qualifications ,)     
respect to ea* inve/igator c>ry+ out !  
/udy "u ?is section1 ! ,secret>y %all   
ensure t ! inve/igator--  7#a7 is       
objective2  7#b7 is qualifi$ to c>ry out
 su* /udy1 z evid5c$ by tra9+ exp]i5ces 
& demon/rat$ skill2  7#c7 is n curr5tly 
employ$ by any ,f$]al1 ,/ate1 or local  
public heal? ag5cy2  7#d7 is n curr5tly 
a memb] ( a bo>d1 committee1 or o!r     
entity responsible = =mulat+            
immunization policy on behalf ( any     

,f$]al1 ,/ate1 or local public heal?    
ag5cy or any compon5t !re(2  7#e7 has no
 hi/ory ( a /rong position on ! ?im]osal
 or vacc9e safety controv]sy2 &  7#f7 is
 n curr5tly an employee (1 or o!rwise   
directly or indirectly receiv+ funds f1 
a ph>maceutical company or ! ,c5t]s =   
,disease ,control4  7d7 ,t>get          
populations ,! ,secret>y %all seek to   
include 9 ! /udy "u ?is section         
populations 9 ! ,unit$ ,/ates t h       
traditionally rema9$ unvacc9at$ =       
religi\s or o!r reasons1 :i* populations
 may include ,old ,ord] ,ami%1 memb]s ( 
cl9ical practices 7su* z ! ,homefir/    
practice 9 ,*icago7 :o *oose alt]native 
m$ical practices1 practition]s (        
an?roposophic life/yles1 & o!rs :o h    
*os5 n to be vacc9at$4  7e7 ,tim+ ,n    
lat] ?an #abj days aft] ! date ( !      
enactm5t ( ?is ,act1 ! ,secret>y %all   
issue a reque/ = proposals to conduct ! 
/udy requir$ by ?is section4 ,n lat] ?an
 #abj days aft] receipt ( any su*       
proposal1 ! ,secret>y %all approve or   

disapprove ! proposal4 ,if ! ,secret>y  
disapproves ! proposal1 ! ,secret>y %all
 provide ! applicant involv$ ) a writt5 
explanation ( ! reasons = ! disapproval4
  7f7 ,transp>5cy ,to facilitate fur!r  
rese>* by ! ,secret>y or o!rs1 !        
,secret>y %all ensure ! pres]vation (   
all data1 includ+ all data sets1        
collect$ or us$ = purposes ( ! /udy "u  
?is section4