,,ii ,cal5d> ,no4 #dbh #aad? ,,congress 
#b;d ,session  ,s4 #bgac  ,,9 ,,!       
,,s5ate ,,( ,,! ,,unit$ ,,/ates  ,m>*   
#ag1 #bjaf,mr4 ,alex&] introduc$ !      
foll[+ bill2 :i* 0 read twice & ref]r$  
to ! ,committee on ,heal?1 ,education1  
,labor1 & ,p5sions  ,april #ah1         
#bjaf,report$ by ,mr4 ,alex&]1 ) an     
amendment,strike out all aft] ! enact+  
clause & ins]t ! "p pr9t$ 9 italic  ,a  
,,bill  ,to provide = ! implem5tation ( 
a ,precision ,m$ic9e ,initiative4  #a4  
,%ort title ,?is ,act may be cit$ z !   
,advanc+ ,precision ,m$ic9e ,act (      
#bjaf4  #b4 ,precision m$ic9e initiative
  7a7 ,9 g5]al ,! ,secret>y ( ,heal? &  
,human ,s]vices 7ref]r$ to 9 ?is section
 z ! ,secret>y7 is enc\rag$ to e/abli% &
 c>ry out an initiative1 to be kn[n z ! 
,precision ,m$ic9e ,initiative1 to      
augm5t ef=ts to address disease         
prev5tion1 diagnosis1 & treatm5t4  7b7  
,compon5ts ,! ,initiative describ$ "u   
subsection 7a7 may include--  7#a7      
develop+ a network ( sci5ti/s to assi/ 9

 c>ry+ out ! purposes ( ! ,initiative2  
7#b7 develop+ new approa*es = address+  
sci5tific1 m$ical1 public heal?1 &      
regulatory sci5ce issues2  7#c7 apply+  
g5omic te*nologies to provide data on ! 
molecul> basis ( disease2  7#d7 collect+
 in=mation volunt>ily provid$ by a      
div]se cohort ( individuals t c be us$  
to bett] und]/& heal? & disease2 &  7#e7
 o!r activities det]m9$ appropriate by !
 ,secret>y to advance ! goals ( !       
,initiative4  7c7 ,au?ority ( !         
,secret>y ,9 c>ry+ out ?is section1 !   
,secret>y may--  7#a7 coord9ate ) !     
,secret>y ( ,en]gy1 private indu/ry1 &  
o!rs det]m9$ appropriate by ! ,secret>y 
to id5tify & address ! advanc$          
sup]comput+ ne$s = ! ,initiative        
describ$ "u subsection 7a72  7#b7       
develop & utilize public-private        
p>tn]%ips2 &  7#c7 lev]age exi/+ data   
s\rces4  7d7 ,requirem5ts ,9 !          
implem5tation ( ! ,initiative "u        
subsection 7a71 ! ,secret>y %all--  7#a7
 ensure ! collaboration ( ! ,national   

,in/itutes ( ,heal?1 ! ,food & ,drug    
,adm9i/ration1 & ! ,(fice ( ! ,national 
,coord9ator = ,heal? ,in=mation         
,te*nology2  7#b7 comply ) exi/+ laws & 
regulations = ! protection ( human      
subjects involv$ 9 rese>*1 includ+ !    
protection ( p>ticipant privacy2  7#c7  
implem5t policies & me*anisms =         
appropriate secure data %>+ across      
sy/ems t include protections = privacy &
 security ( data2 &  7#d7 consid] !     
div]sity ( ! cohort to ensure inclusion 
( a broad range ( p>ticipants1 includ+  
consid]ation ( biological1 social1 & o!r
 det]m9ants ( heal? t contribute to     
heal? disp>ities4  #a4 ,%ort title ,?is 
,act may be cit$ z ! ,advanc+ ,precision
 ,m$ic9e ,act ( #bjaf4  #b4 ,precision  
m$ic9e initiative  7a7 ,9 g5]al ,!      
,secret>y ( ,heal? & ,human ,s]vices    
7ref]r$ to 9 ?is section z ! ,secret>y7 
is enc\rag$ to e/abli% & c>ry out an    
initiative1 to be kn[n z ! ,precision   
,m$ic9e ,initiative1 to augm5t ef=ts to 
address disease prev5tion1 diagnosis1 & 

treatm5t4  7b7 ,compon5ts ,! ,initiative
 describ$ "u subsection 7a7 may         
include--  7#a7 develop+ a network (    
sci5ti/s to assi/ 9 c>ry+ out ! purposes
 ( ! ,initiative2  7#b7 develop+ new    
approa*es = address+ sci5tific1 m$ical1 
public heal?1 & regulatory sci5ce       
issues2  7#c7 apply+ g5omic te*nologies1
 su* z :ole g5omic sequ5c+1 to provide  
data on ! molecul> basis ( disease2     
7#d7 collect+ in=mation volunt>ily      
provid$ by a div]se cohort ( individuals
 t c be us$ to bett] und]/& heal? &     
disease2 &  7#e7 o!r activities det]m9$ 
appropriate by ! ,secret>y to advance ! 
goals ( ! ,initiative4  7c7 ,au?ority ( 
! ,secret>y ,9 c>ry+ out ?is section1 ! 
,secret>y may--  7#a7 coord9ate ) !     
,secret>y ( ,en]gy1 private indu/ry1 &  
o!rs det]m9$ appropriate by ! ,secret>y 
to id5tify & address ! advanc$          
sup]comput+ ne$s = ! ,initiative        
describ$ "u subsection 7a72  7#b7       
develop & utilize public-private        
p>tn]%ips2 &  7#c7 lev]age exi/+ data   

s\rces4  7d7 ,requirem5ts ,9 !          
implem5tation ( ! ,initiative "u        
subsection 7a71 ! ,secret>y %all--  7#a7
 ensure ! collaboration ( ! ,national   
,in/itutes ( ,heal?1 ! ,food & ,drug    
,adm9i/ration1 & ! ,(fice ( ! ,national 
,coord9ator = ,heal? ,in=mation         
,te*nology2  7#b7 comply ) exi/+ laws & 
regulations = ! protection ( human      
subjects involv$ 9 rese>*1 includ+ !    
protection ( p>ticipant privacy2  7#c7  
implem5t policies & me*anisms =         
appropriate secure data %>+ across      
sy/ems t include protections = privacy &
 security ( data2 &  7#d7 consid] !     
div]sity ( ! cohort to ensure inclusion 
( a broad range ( p>ticipants1 includ+  
consid]ation ( biological1 social1 & o!r
 det]m9ants ( heal? t contribute to     
heal? disp>ities4  #c4 ,protection (    
privacy ( individuals :o are rese>*     
subjects  7a7 ,9 g5]al ,subsection 7d7 (
 section #cja ( ! ,public ,heal? ,s]vice
 ,act 7#db ,u4,s4,c4 #bda7 is am5d$ to  
read z foll[s3  7d7 ,protection (       

privacy ( individuals :o are rese>*     
subjects  7#a7 ,issuance ( c]tificate   
7,a7 ,9 g5]al ,if a p]son is engag$ 9   
biom$ical1 behavioral1 cl9ical1 or o!r  
rese>*1 9 :i* id5tifiable1 s5sitive     
in=mation is collect$ 7includ+ rese>* on
 m5tal heal? & rese>* on ! use & effect 
( alcohol & o!r psy*oactive drugs71 !   
,secret>y1 9 coord9ation ) o!r          
,dep>tm5ts1 z applicable--  7i7 %all    
issue to su* p]son a c]tificate (       
confid5tiality to protect ! privacy (   
individuals :o are ! subjects ( su*     
rese>* if ! rese>* is fund$ :olly or 9  
"p by ! ,f$]al ,gov]nm5t2 &  7ii7 may1  
^u application by a p]son engag$ 9      
rese>*1 issue to su* p]son a c]tificate 
( confid5tiality to protect ! privacy ( 
su* individuals if ! rese>* is n s      
fund$4  7,b7 ,result ( c]tificate       
,except z provid$ 9 subp>agraph 7,c71   
any p]son to :om a c]tificate is issu$  
"u subp>agraph 7,a7 to protect ! privacy
 ( individuals describ$ 9 su*           
subp>agraph %all n disclose or provide  

to any o!r p]son n connect$ ) ! rese>* !
 "n ( su* an individual or any          
in=mation1 docum5t1 or biospecim5 t     
conta9s id5tifiable1 s5sitive in=mation 
ab\t su* an individual & t 0 creat$ or  
compil$ = purposes ( ! rese>*4  7,c7    
,exceptions ,! disclosure prohibition 9 
subp>agraph 7,b7 %all n apply to        
disclosure or use t is-- 7i7 requir$ by 
,f$]al1 ,/ate1 or local laws1 exclud+   
in/ances describ$ 9 subp>agraph 7,d72   
7ii7 necess>y = ! m$ical treatm5t ( !   
individual to :om ! in=mation1 docum5t1 
or biospecim5 p]ta9s2  7iii7 made ) !   
cons5t ( ! individual to :om !          
in=mation1 docum5t1 or biospecim5       
p]ta9s2 or  7iv7 made = ! purposes ( o!r
 sci5tific rese>* t is 9 compliance )   
applicable ,f$]al regulations gov]n+ !  
protection ( human subjects 9 rese>*4   
7,d7 ,prohibition on compell+ disclosure
 ,any p]son to :om a c]tificate is issu$
 "u subp>agraph 7,a7 to protect !       
privacy ( an individual describ$ 9 su*  
subp>agraph %all n1 9 any ,f$]al1 ,/ate1

 or local civil1 crim9al1 adm9i/rative1 
legislative1 or o!r proce$+1 disclose or
 provide ! "n ( su* individual or any   
su* in=mation1 docum5t1 or biospecim5 t 
conta9s id5tifiable1 s5sitive in=mation 
ab\t ! individual & t 0 creat$ or       
compil$ = purposes ( ! rese>*4  7,e7    
,immunity ,id5tifiable1 s5sitive        
in=mation protect$ "u subp>agraph 7,a71 
& all copies !re(1 %all be immune f !   
legal process1 & %all n1 )\t ! cons5t ( 
! individual to :om ! in=mation p]ta9s1 
be admissible z evid5ce or us$ = any    
purpose 9 any action1 suit1 or o!r      
judicial1 legislative1 or adm9i/rative  
proce$+4  7,f7 ,t]ms ( protection       
,id5tifiable1 s5sitive in=mation        
collect$ by a p]son to :om a c]tificate 
has be5 issu$ "u subp>agraph 7,a71 & all
 copies !re(1 %all be subject to !      
protections af=d$ by ?is section =      
p]petuity4  7,g7 ,m9imiz+ adm9i/rative  
burd5 ,! ,secret>y %all take /eps to    
m9imize ! burd5 to rese>*]s1 /reaml9e ! 
process1 & r$uce ! "t x takes to comply 

) ! requirem5ts ( ?is subsection4  7#b7 
,rule ( con/ruction ,no?+ 9 ?is         
subsection %all be con/ru$ to limit !   
access ( an individual :o is a subject (
 rese>* to in=mation ab\t himself or    
h]self collect$ dur+ su* individual's   
p>ticipation 9 ! rese>*4  7#c7          
,def9itions ,= purposes ( ?is           
subsection1 ! t]m id5tifiable1 s5sitive 
in=mation means in=mation t is ab\t an  
individual & t is ga!r$ or us$ dur+ !   
c\rse ( rese>* describ$ 9 p>agraph      
7#a77;,a7 &--  7,a7 ?r\gh :i* an        
individual is id5tifi$2 or  7,b7 = :i*  
!re is a risk1 z det]m9$ by curr5t      
sci5tific practices or /ati/ical me?ods1
 t "s comb9ation ( ! in=mation1 !       
reque/1 & o!r available data s\rces c\ld
 be us$ to d$uce ! id5tity ( an         
individual4  4  7b7 ,applicability      
,beg9n+ on ! date ( enactm5t ( ?is ,act1
 all p]sons engag$ 9 rese>* & au?oriz$  
by ! ,secret>y ( ,heal? & ,human        
,s]vices to protect in=mation "u section
 #cja7;d7 ( ! ,public ,heal? ,s]vice    

,act 7#db ,u4,s4,c4 #bda7;d77 prior to !
 date ( enactm5t ( ?is ,act %all be     
subject to ! requirem5ts ( su* section  
7z am5d$ by ?is ,act74  #d4 ,protection 
( id5tifiable1 s5sitive in=mation       
,section #cja ( ! ,public ,heal? ,s]vice
 ,act 7#db ,u4,s4,c4 #bda7 is am5d$ by  
add+ at ! end ! foll[+3  7f7 7#a7 ,!    
,secret>y may exempt f disclosure "u    
section #eeb7;b77#c7 ( title #e1 ,unit$ 
,/ates ,code1 biom$ical in=mation t is  
ab\t an individual & t is ga!r$ or us$  
dur+ ! c\rse ( biom$ical rese>* if--    
7,a7 an individual is id5tifi$2 or  7,b7
 !re is a risk1 z det]m9$ by curr5t     
sci5tific practices or /ati/ical me?ods1
 t "s comb9ation ( ! in=mation1 !       
reque/1 & o!r available data s\rces c\ld
 be us$ to d$uce ! id5tity ( an         
individual4  7#b7 7,a7 ,ea* det]m9ation 
( ! ,secret>y "u p>agraph 7#a7 to exempt
 in=mation f disclosure %all be made 9  
writ+ & accompani$ by a /atem5t ( !     
basis = ! det]m9ation4  7,b7 ,ea* su*   
det]m9ation & /atem5t ( basis %all be   

available to ! public1 ^u reque/1 ?r\gh 
! ,(fice ( ! ,*ief ,,foia ,(fic] ( !    
,dep>tm5t ( ,heal? & ,human ,s]vices4   
7#c7 ,no?+ 9 ?is subsection %all be     
con/ru$ to limit a rese>* p>ticipant's  
access to in=mation ab\t su* p>ticipant 
collect$ dur+ ! p>ticipant's            
p>ticipation 9 ! rese>*4  4  #e4 ,data  
%>+ ,section #djb7;b7 ( ! ,public ,heal?
 ,s]vice ,act 7#db ,u4,s4,c4 #bhb7;b77  
is am5d$-- 7#a7 9 p>agraph 7#bc71 by    
/rik+ & at ! end2  7#b7 9 p>agraph      
7#bd71 by /rik+ ! p]iod & ins]t+ 2 &2 & 
7#c7 by ins]t+ aft] p>agraph 7#bd7 !    
foll[+3  7#be7 may require recipi5ts (  
,,nih grants or coop]ative agreem5ts to 
%>e sci5tific data1 to ! ext5t feasible1
 g5]at$ f su* ,,nih grants or coop]ative
 agreem5ts 9 a mann] t is consi/5t ) all
 applicable ,f$]al laws & regulations1  
includ+ su* laws & regulations = !      
protection (--  7,a7 human rese>*       
p>ticipants1 includ+ ) respect to       
privacy1 security1 in=m$ cons5t1 &      
protect$ heal? in=mation2  7,b7         

propriet>y int]e/s1 confid5tial         
comm]cial in=mation1 & ! intellectual   
prop]ty rights ( ! fund+ recipi5t2 &    
7,c7 national1 homel&1 & economic       
security int]e/s4  4  #f4 ,high-risk1   
high-rew>d rese>*  7a7 ,9 g5]al ,section
 #djb ( ! ,public ,heal? ,s]vice ,act   
7#db ,u4,s4,c4 #bhb7 is am5d$ by add+ at
 ! end ! foll[+3  7m7 ,high-risk1       
high-rew>d rese>*  7#a7 ,9 g5]al ,!     
,director ( ,,nih may approve1 aft]     
consid]ation ( a proposal "u p>agraph   
7#b77;,a71 reque/s by ! national rese>* 
in/itutes & c5t]s1 or program (fices )9 
! ,(fice ( ! ,director1 to engage 9     
transactions o!r ?an a contract1 grant1 
or coop]ative agreem5t ) respect to     
projects = high-impact1 cutt+-edge      
rese>* t fo/]s sci5tific creativity &   
increases fundam5tal biological und]/&+ 
lead+ to ! prev5tion1 diagnosis1 or     
treatm5t ( diseases & disord]s4  7#b7   
,requirem5ts ,! au?ority provid$ "u ?is 
subsection may be us$ to conduct or     
support high-impact1 cutt+-edge rese>*  

describ$ 9 p>agraph 7#a7 us+ ! o!r      
transactions au?ority describ$ 9 su*    
p>agraph if ! in/itute1 c5t]1 or (fice--
  7,a7 submits a proposal to ! ,director
 ( ,,nih = ! use ( su* au?ority be=e    
conduct+ or support+ ! rese>*1 includ+  
:y ! use ( su* au?ority is ess5tial to  
promot+ ! success ( ! project2  7,b7    
receives approval = ! use ( su* au?ority
 f ! ,director ( ,,nih2 &  7,c7 = ea*   
ye> 9 :i* ! in/itute1 c5t]1 or (fice has
 us$ su* au?ority 9 accordance ) ?is    
subsection1 submits a report to !       
,director ( ,,nih on ! activities ( !   
in/itute1 c5t]1 or (fice relat+ to su*  
rese>*4  4  7b7 ,report to ,congress ,n 
lat] ?an ,septemb] #cj1 #bjbj1 !        
,secret>y ( ,heal? & ,human ,s]vices1   
act+ ?r\gh ! ,director ( ! ,national    
,in/itutes ( ,heal?1 %all conduct an    
evaluation ( ! activities "u subsection 
7m7 ( section #djb ( ! ,public ,heal?   
,s]vice ,act 7#db ,u4,s4,c4 #bhb71 z    
add$ by subsection 7a71 & submit a      
report to ! ,committee on ,heal?1       

,education1 ,labor1 & ,p5sions ( !      
,s5ate & ! ,committee on ,en]gy &       
,comm]ce ( ! ,h\se ( ,repres5tatives on 
! results ( su* evaluation4  7c7 ,duties
 ( directors ( in/itutes ,section       
#dje7;b77#a7 ( ! ,public ,heal? ,s]vice 
,act 7#db ,u4,s4,c4 #bhd7;b77#a77 is    
am5d$-- 7#a7 by r$esignat+ subp>agraphs 
7,c7 ?r\gh 7,l7 z subp>agraphs 7,d7     
?r\gh 7,m71 respectively2 &  7#b7 by    
ins]t+ aft] subp>agraph 7,b71 ! foll[+3 
7,c7 %all1 z appropriate1 conduct &     
support rese>* t has ! pot5tial to      
trans=m ! sci5tific field1 has inh]5tly 
high] risk1 & t seeks to address major  
curr5t *all5ges2  4  ,april #ah1        
#bjaf,report$ ) an am5dm5t