#aaf? ,,congress  #a/ ,session  ,h4 ,r4 
#bejg  ,,an ,,act  ,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 ( #bjai4    
#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+ #bjbd2 &  7,b7 9
 p>agraph 7#b7 by /rik+ #bjai & ins]t+  
#bjbd4  #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+           
#ca1jjj1jjj2  7,b7 by /rik+ #bjae &     
ins]t+ #bjbj2 &  7,c7 by /rik+ #bjai &  
ins]t+ #bjbd2 &  7#b7 9 p>agraph 7#b7-- 
7,a7 by /rik+ #h1jjj1jjj & ins]t+       
#bi1fej1jjj2  7,b7 by /rik+ #bjae &     
ins]t+ #bjbj2 &  7,c7 by /rik+ #bjai &  
ins]t+ #bjbd4  #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  #i4 ,,nam  
report on ! mod]nization ( newborn      
scre5+  7a7 ,/udy ,n lat] ?an #fj days  

aft] ! date ( ! enactm5t ( ?is ,act1 !  
,secret>y ( ,heal? & ,human ,s]vices    
%all seek to ent] into an agreem5t ) !  
,national ,academy ( ,m$ic9e 79 ?is     
section ref]r$ to z ,,nam7 7or if ,,nam 
decl9es to ent] into su* an agreem5t1   
ano!r appropriate entity7 "u :i* ,,nam1 
or su* o!r appropriate entity1 agrees to
 conduct a /udy on ! foll[+3 7#a7 ,!    
uni=m scre5+ panel review &             
recomm5dation processes to id5tify      
factors t impact decisions to add new   
conditions to ! uni=m scre5+ panel1 to  
describe *all5ges pos$ by newly nom9at$ 
conditions1 includ+ l[-incid5ce         
diseases1 late onset v>iants1 & new     
treatm5ts )\t long-t]m efficacy data4   
7#b7 ,! b>ri]s t preclude ,/ates f add+ 
new uni=m scre5+ panel conditions to _! 
,/ate scre5+ panels ) recomm5dations on 
res\rces ne$$ to help ,/ates implem5t   
uni=m scre5+ panel recomm5dations4  7#c7
 ,! curr5t /ate ( f$]ally & privately   
fund$ newborn scre5+ rese>* )           
recomm5dations = optimiz+ ! capacity (  

?is rese>*1 includ+ pilot+ multiple     
prospective conditions at once &        
address+ r>e disease que/ions4  7#d7    
,new & em]g+ te*nologies t w\ld p]mit   
scre5+ = new categories ( disord]s1 or  
w\ld make curr5t scre5+ m effective1 m  
effici5t1 or less exp5sive4  7#e7       
,te*nological & o!r infra/ructure ne$s  
to improve timel9ess ( diagnosis & %ort-
 & long-t]m foll[-up = infants id5tifi$ 
?r\gh newborn scre5+ & improve public   
heal? surveillance4  7#f7 ,curr5t &     
future communication & educational ne$s 
= priority /akehold]s & ! public to     
promote und]/&+ & k ( a mod]niz$ newborn
 scre5+ sy/em ) an emphasis on evolv+   
communication *annels & messag+4  7#g7  
,! ext5t to :i* newborn scre5+ yields   
bett] data on ! disease preval5ce =     
scre5$ conditions & improves long-t]m   
outcomes = ^? id5tifi$ ?r\gh newborn    
scre5+1 includ+ exi/+ sy/ems support+   
su* data collection & recomm5dations =  
sy/ems t w\ld all[ = improv$ data       
collection4  7#h7 ,! impact on newborn  

morbidity & mortality 9 ,/ates t adopt  
newborn scre5+ te/s includ$ on ! uni=m  
panel4  7b7 ,public /akehold] meet+ ,9 !
 c\rse ( complet+ ! /udy describ$ 9     
subsection 7a71 ,,nam or su* o!r        
appropriate entity %all hold n less ?an 
"o public meet+ to obta9 /akehold] input
 on ! topics ( su* /udy4  7c7 ,report ,n
 lat] ?an #ah mon?s aft] ! effective    
date ( ! agreem5t "u subsection 7a71 su*
 agreem5t %all require ,,nam1 or su* o!r
 appropriate entity1 to submit to !     
,secret>y ( ,heal? & ,human ,s]vices & !
 appropriate committees ( jurisdiction (
 ,congress a report conta9+-- 7#a7 !    
results ( ! /udy conduct$ "u subsection 
7a72  7#b7 recomm5dations to mod]nize ! 
processes describ$ 9 subsection 7a77#a72
 &  7#c7 recomm5dations = su*           
legislative & adm9i/rative action z     
,,nam1 or su* o!r appropriate entity1   
det]m9es appropriate4  7d7 ,au?orization
 ( appropriations ,!re is au?oriz$ to be
 appropriat$ #b1jjj1jjj = ! p]iod (     
fiscal ye>s #bjbj & #bjba to c>ry out   

?is section4  ,pass$ ! ,h\se (          
,repres5tatives ,july #bd1 #bjai4;,cl]k4