,i  #aai? ,,congress  #a/ ,session  ,h4 
,r4 #dgji  ,,9 ,,! ,,h\se ,,(           
,,repres5tatives  ,july #bc1 #bjbe,ms4  
,morrison 7= h]self1 ,mr4 ,simpson1 ,ms4
 ,s*ri]1 & ,mr4 ,langwor?y7 introduc$ ! 
foll[+ bill2 :i* 0 ref]r$ to !          
,committee on ,en]gy & ,comm]ce  ,a     
,,bill  ,to am5d ! ,public ,heal?       
,s]vice ,act to reau?orize c]ta9        
programs "u "p ,a ( title ,,xi ( su*    
,act relat+ to g5etic diseases1 & = o!r 
purposes4  #a4 ,%ort title ,?is ,act may
 be cit$ z ! ,newborn ,scre5+ ,saves    
,lives ,reau?orization ,act ( #bjbe4    
#b4 ,improv$ newborn & *ild scre5+ &    
foll[-up = h]itable disord]s  7a7       
,purposes ,section #aaji7;a7 ( ! ,public
 ,heal? ,s]vice ,act 7#db ,u4,s4,c4     
#cjj;b-#h7;a77 is am5d$--  7#a7 9       
p>agraph 7#a71 by /rik+ enhance1 improve
 or & ins]t+ facilitate1 enhance1       
improve1 or2  7#b7 by am5d+ p>agraph    
7#c7 to read z foll[s3  7#c7 to develop1
 & deliv] to p>5ts1 families1 & pati5t  
advocacy & support gr\ps1 educational   

programs t-- 7,a7 address newborn scre5+
 c\nsel+1 te/+ 7includ+ newborn scre5+  
pilot /udies71 foll[-up1 treatm5t1      
specialty s]vices1 & long-t]m c>e2  7,b7
 assess ! t>get audi5ce's curr5t k1     
incorporate heal? communications        
/rategies1 & measure impact2 &  7,c7 are
 at appropriate lit]acy levels2  2 &    
7#c7 9 p>agraph 7#d7-- 7,a7 by /rik+    
foll[up & ins]t+ foll[-up2 &  7,b7 by   
ins]t+ be=e ! semicolon at ! end !      
foll[+3 1 includ+ re-engag+ pati5ts :o h
 n receiv$ recomm5d$ foll[-up s]vices & 
supports4  7b7 ,approval factors        
,section #aaji7;c7 ( ! ,public ,heal?   
,s]vice ,act 7#db ,u4,s4,c4             
#cjj;b-#h7;c77 is am5d$--  7#a7 by /rik+
 or w use & ins]t+ w use2 &  7#b7 by    
ins]t+ 1 or w use am\nts receiv$ "u su* 
grant to enhance capacity &             
infra/ructure to facilitate ! adoption  
(1 be=e ! guidel9es & recomm5dations4   
#c4 ,advisory committee on h]itable     
disord]s 9 newborns & *ildr5 ,section   
#aaaa ( ! ,public ,heal? ,s]vice ,act   

7#db ,u4,s4,c4 #cjj;b-#aj7 is am5d$--   
7#a7 9 subsection 7b7--  7,a7 9 p>agraph
 7#e71 by ins]t+ & adopt process        
improvem5ts aft] take appropriate /eps2 
7,b7 9 p>agraph 7#g7 by /rik+ & at !    
end2  7,c7 by r$esignat+ p>agraph 7#h7 z
 p>agraph 7#i72  7,d7 by ins]t+ aft]    
p>agraph 7#g7 ! foll[+3  7#h7 develop1  
ma9ta91 & publi% on a publicly          
accessible website consum]-fri5dly      
mat]ials detail+-- 7,a7 ! uni=m scre5+  
panel nom9ation process1 includ+ data   
requirem5ts1 /&>ds1 & ! use (           
int]national data 9 nom9ation           
submissions2 &  7,b7 ! process = obta9+ 
te*nical assi/ance = submitt+ nom9ations
 to ! uni=m scre5+ panel & detail+ !    
in/ances 9 :i* ! provision ( te*nical   
assi/ance w\ld introduce a conflict (   
int]e/ = memb]s ( ! ,advisory           
,committee2 &  2 &  7,e7 9 p>agraph     
7#i71 z r$esignat$--  7i7 by r$esignat+ 
subp>agraphs 7,k7 & 7,l7 z subp>agraphs 
7,l7 & 7,m71 respectively2 &  7ii7 by   
ins]t+ aft] subp>agraph 7,j7 ! foll[+3  

7,k7 ! appropriate & recomm5d$ use (    
safe & effective g5etic te/+ by heal?   
c>e pr(essionals 9 newborns & *ildr5 )  
an initial diagnosis ( a disease or     
condition *>act]iz$ by a v>iety ( g5etic
 causes & manife/ations2  2 &  7#b7 9   
subsection 7g7--  7,a7 9 p>agraph 7#a7  
by /rik+ #bjai & ins]t+ #bjcj2 &  7,b7 9
 p>agraph 7#b7 by /rik+ #bjai & ins]t+  
#bjcj4  #d4 ,cle>+h\se ( newborn scre5+ 
in=mation ,section #aaab7;c7 ( ! ,public
 ,heal? ,s]vice ,act 7#db ,u4,s4,c4     
#cjj;b-#aa7;c77 is am5d$ by /rik+ &     
supplem5t1 n supplant1 exi/+ in=mation  
%>+ ef=ts & ins]t+ & complem5t o!r      
,f$]al newborn scre5+ in=mation %>+     
activities4  #e4 ,laboratory quality &  
surveillance ,section #aaac ( ! ,public 
,heal? ,s]vice ,act 7#db ,u4,s4,c4      
#cjj;b-#ab7 is am5d$--  7#a7 9          
subsection 7a7-- 7,a7 9 p>agraph 7#a7-- 
7i7 by /rik+ p]=mance evaluation        
s]vices1 & ins]t+ developm5t ( new      
scre5+ te/s12 &  7ii7 by /rik+ & at !   
end2  7,b7 9 p>agraph 7#b7-- 7i7 by     

/rik+ p]=mance te/ mat]ials & ins]t+ te/
 p]=mance mat]ials2 &  7ii7 by /rik+ !  
p]iod at ! end & ins]t+ 2 &2 &  7,c7 by 
add+ at ! end ! foll[+3  7#c7 p]=mance  
evaluation s]vices to enhance disease   
detection1 includ+ ! developm5t ( tools1
 res\rces1 & infra/ructure to improve   
data analysis1 te/ result int]pretation1
 data h>monization1 & dissem9ation (    
laboratory be/ practices4  2 &  7#b7 9  
subsection 7b7 to read z foll[s3  7b7   
,surveillance activities ,! ,secret>y1  
act+ ?r\gh ! ,director ( ! ,c5t]s =     
,disease ,control & ,prev5tion1 & tak+  
into consid]ation ! exp]tise ( !        
,advisory ,committee on ,h]itable       
,disord]s 9 ,newborns & ,*ildr5 e/abli%$
 "u section #aaaa1 %all provide = !     
coord9ation ( national surveillance     
activities1 includ+-- 7#a7 /&>diz+ data 
collection & report+ ?r\gh ! use (      
electronic & o!r =ms ( heal? records to 
a*ieve real-"t data = track+ & monitor+ 
! newborn scre5+ sy/em1 f ! initial     
positive scre5 ?r\gh diagnosis &        

long-t]m c>e managem5t2 &  7#b7 by      
promot+ data %>+ l9kages betwe5 ,/ate   
newborn scre5+ programs & ,/ate-bas$    
bir? defects & developm5tal disabilities
 surveillance programs to help families 
connect ) s]vices to assi/ 9 evaluat+   
long-t]m outcomes4  4  #f4 ,hunt] ,kelly
 rese>* program ,section #aaaf ( !      
,public ,heal? ,s]vice ,act 7#db        
,u4,s4,c4 #cjj;b-#ae7 is am5d$--  7#a7 9
 subsection 7a77#a7-- 7,a7 by /rik+ may 
& ins]t+ %all2 &  7,b7 9 subp>agraph    
7,d7-- 7i7 by ins]t+ 1 or ) a high      
probability ( be+ recomm5d$ by1 aft]    
recomm5d$ by2 &  7ii7 by /rik+ t scre5+s
 are ready = nationwide implem5tation & 
ins]t+ t reliable newborn scre5+        
te*nologies are pilot$ & ready = use2 & 
7#b7 9 subsection 7b7 to read z foll[s3 
7b7 ,fund+ ,9 c>ry+ out ! rese>* program
 "u ?is section1 ! ,secret>y & !        
,director %all ensure t entities receiv+
 fund+ ?r\gh ! program w provide        
assurances1 z practicable1 t su*        
entities w "w 9 consultation ) ,/ate    

dep>tm5ts ( heal?1 z appropriate4  4    
#g4 ,au?orization ( appropriations =    
newborn scre5+ programs & activities    
,section #aaag ( ! ,public ,heal?       
,s]vice ,act 7#db ,u4,s4,c4 #cjj;b-#af7 
is am5d$--  7#a7 9 p>agraph 7#a7-- 7,a7 
by /rik+ #aa1ijj1jjj & ins]t+           
#bj1hhc1jjj2  7,b7 by /rik+ #bjae &     
ins]t+ #bjbf2 &  7,c7 by /rik+ #bjai &  
ins]t+ #bjcj2 &  7#b7 9 p>agraph 7#b7-- 
7,a7 by /rik+ #h1jjj1jjj & ins]t+       
#bb1bej1jjj2  7,b7 by /rik+ #bjae &     
ins]t+ #bjbf2 &  7,c7 by /rik+ #bjai &  
ins]t+ #bjcj4  #h4 ,in/itutional review 
bo>ds2 e?ics guidance program ,section  
#ab ( ! ,newborn ,scre5+ ,saves ,lives  
,reau?orization ,act ( #bjad 7#db       
,u4,s4,c4 #bhi note7 is am5d$ to read z 
foll[s3  #ab4 ,in/itutional review      
bo>ds2 e?ics guidance program ,rese>* on
 nonid5tifi$ newborn dri$ blood spots   
%all be consid]$ second>y rese>* 7z t   
t]m is def9$ 9 section #df4ajd7;d77#d7 (
 title #de1 ,code ( ,f$]al ,regulations 
7or successor regulations77 )           

nonid5tifi$ biospecim5s = purposes (    
f$]ally fund$ rese>* conduct$ pursuant  
to ! ,public ,heal? ,s]vice ,act 7#db   
,u4,s4,c4 #bjj et seq474  4