,,ii ,cal5d> ,no4 #dbi #aad? ,,congress 
#b;d ,session  ,s4 #bgdb  ,,9 ,,!       
,,s5ate ,,( ,,! ,,unit$ ,,/ates  ,april 
#d1 #bjaf,mr4 ,alex&] 7= himself1 ,mrs4 
,murray1 ,mr4 ,kirk1 & ,ms4 ,w>r57      
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 am5d title ,,iv
 ( ! ,public ,heal? ,s]vice ,act reg>d+ 
! national rese>* in/itutes1 & = o!r    
purposes4  #a4 ,%ort title ,?is ,act may
 be cit$ z ! ,promot+ ,biom$ical ,rese>*
 & ,public ,heal? = ,pati5ts ,act4  #b4 
,tri5nial reports ( ,director ( ,,nih   
,section #djc ( ! ,public ,heal? ,s]vice
 ,act 7#db ,u4,s4,c4 #bhc7 is am5d$--   
7#a7 9 ! head+1 by /rik+ ,bi5nial &     
ins]t+ ,tri5nial2 &  7#b7 9 subsection  
7a7-- 7,a7 9 ! matt] prec$+ p>agraph    
7#a71 by /rik+ bi5nial & ins]t+         
tri5nial2  7,b7 by am5d+ p>agraph 7#c7  

to read z foll[s3  7#c7 ,a description (
 intra-,,nih activities1 includ+        
id5tification ( ! p]c5tage ( funds made 
available by ea* national rese>*        
in/itute & national c5t] ) respect to   
ea* applicable fiscal ye> = conduct+ or 
support+ rese>* t involves collaboration
 betwe5 ! in/itute or c5t] & #a or m o!r
 national rese>* in/itutes or national  
c5t]s & recomm5dations = promot+        
coord9ation ( in=mation among ! c5t]s ( 
excell5ce4  2  7,c7 9 p>agraph 7#d7--   
7i7 9 subp>agraph 7,b71 by /rik+        
demographic v>iables & o!r v>iables &   
ins]t+ demographic v>iables1 includ+    
biological & social v>iables & relevant 
age categories1 & det]m9ants ( heal?2 & 
7ii7 9 subp>agraph 7,c77v7-- 7,i7 by    
/rik+ demographic v>iables & su* &      
ins]t+ demographic v>iables1 includ+    
relevant age categories1 in=mation      
submitt$ by ea* national rese>* in/itute
 & national c5t] to ! ,director ( ,,nih 
"u section #dib;,b7f71 & su*2 &  7,,ii7 
by /rik+ 7reg>d+ inclusion ( wom5 &     

m9orities 9 cl9ical rese>*7 & ins]t+ &  
o!r applicable requirem5ts reg>d+       
inclusion ( demographic gr\ps2 &  7,d7 9
 p>agraph 7#f7--  7i7 9 ! matt] prec$+  
subp>agraph 7,a71 by /rik+ ! foll[+3 &  
ins]t+ ! foll[+--2  7ii7 9 subp>agraph  
7,a7--  7,i7 by /rik+ ,an evaluation &  
ins]t+ an evaluation2 &  7,,ii7 by /rik+
 ! p]iod & ins]t+ 2 &2  7iii7 by /rik+  
subp>agraphs 7,b7 & 7,d72  7iv7 by      
r$esignat+ subp>agraph 7,c7 z           
subp>agraph 7,b72 &  7v7 9 subp>agraph  
7,b71 z r$esignat$ by clause 7iv71 by   
/rik+ ,recomm5dations & ins]t+          
recomm5dations4  #c4 ,adm9i/rative burd5
 on inve/igators  7a7 ,disclosure (     
f9ancial conflicts ( int]e/  7#a7 ,9    
g5]al ,n lat] ?an #b ye>s aft] ! date ( 
enactm5t ( ?is ,act1 ! ,secret>y (      
,heal? & ,human ,s]vices 7ref]r$ to 9   
?is section z ! ,secret>y7 %all--  7,a7 
lead a review by rese>* fund+ ag5cies ( 
all regulations & policies relat$ to !  
disclosure ( f9ancial conflicts (       
int]e/1 includ+ ! m9imum ?re%old =      

report+ f9ancial conflicts ( int]e/2 &  
7,b7 make revisions1 z appropriate1 to  
h>monize exi/+ policies & r$uce         
adm9i/rative burd5 on rese>*]s :ile     
ma9ta9+ ! integrity & cr$ibility (      
rese>* f9d+s & protections ( human      
p>ticipants4  7#b7 ,consid]ations ,9    
updat+ policies "u p>agraph 7#a77;,b71 !
 ,secret>y %all consid]--  7,a7 modify+ 
! timel9es = ! report+ ( f9ancial       
conflicts ( int]e/ to j 9 "t in=mation  
by in/itutions receiv+ grant or         
coop]ative agreem5t fund+ f ! ,national 
,in/itutes ( ,heal?2  7,b7 ensur+ t     
f9ancial int]e/ disclosure report+      
requirem5ts are appropriate =1 &        
relevant to1 aw>ds t w directly fund    
rese>*1 :i* may include modification ( !
 def9ition ( ! t]m inve/igator2 &  7,c7 
updat+ any applicable tra9+ modules ( ! 
,national ,in/itutes ( ,heal? relat$ to 
,f$]al f9ancial int]e/ disclosure4  7b7 
,monitor+ ( subrecipi5ts ( fund+ f !    
,national ,in/itutes ( ,heal? ,!        
,director ( ! ,national ,in/itutes (    

,heal? %all implem5t measures to r$uce !
 adm9i/rative burd5s relat$ to monitor+ 
( subrecipi5ts ( grants by prim>y       
aw>dees ( fund+ f ! ,national ,in/itutes
 ( ,heal?1 :i* may incorporate f9d+s &  
recomm5dations f exi/+ & ongo+          
activities4 ,su* measures may include1 z
 appropriate--  7#a7 an exemption f     
subrecipi5t monitor+ requirem5ts1 ^u    
reque/ f ! prim>y aw>dees1 provid$ t--  
7,a7 ! subrecipi5t is subject to ,f$]al 
audit requirem5ts pursuant to ! ,uni=m  
,guidance ( ! ,(fice ( ,managem5t &     
,budget2  7,b7 ! prim>y aw>dee conducts 
a =mal or in=mal evaluation ( ea*       
subrecipi5t's risk ( noncompliance )    
,f$]al /atutes & regulations1 & !       
conditions ( ! subaw>d2 &  7,c7 su*     
exemption does n absolve ! prim>y aw>dee
 ( liability = misconduct by            
subrecipi5ts2 &  7#b7 ! implem5tation ( 
alt]native grant /ructures t obviate !  
ne$ = subrecipi5t monitor+1 :i* may     
include collaborative grant models all[+
 = multiple prim>y aw>dees4  7c7        

,report+ ( f9ancial exp5ditures ,!      
,secret>y1 9 consultation ) ! ,director 
( ! ,national ,in/itutes ( ,heal?1 %all 
evaluate f9ancial exp5diture report+    
proc$ures & requirem5ts = recipi5ts (   
fund+ f ! ,national ,in/itutes ( ,heal? 
& take action1 z appropriate1 to avoid  
duplication betwe5 dep>tm5t & ag5cy     
proc$ures & requirem5ts & m9imize burd5 
to fund+ recipi5ts4  7d7 ,animal c>e &  
use 9 rese>* ,n lat] ?an #b ye>s aft] ! 
date ( enactm5t ( ?is ,act1 ! ,director 
( ! ,national ,in/itutes ( ,heal?1 9    
collaboration ) ! ,secret>y (           
,agriculture & ! ,commission] ( ,food & 
,drugs1 %all complete a review (        
applicable regulations & policies = !   
c>e & use ( laboratory animals & make   
revisions1 z appropriate1 to r$uce      
adm9i/rative burd5 on inve/igators :ile 
ma9ta9+ ! integrity & cr$ibility (      
rese>* f9d+s & protection ( rese>*      
animals4 ,9 c>ry+ out ?is ef=t1 !       
,director %all seek ! input ( exp]ts1 z 
appropriate4 ,! ,director %all--  7#a7  

id5tify ways to ensure su* regulations &
 policies are n inconsi/5t1 ov]lapp+1 or
 unnecess>ily duplicative1 includ+ )    
respect to inspection & review          
requirem5ts by ,f$]al ag5cies & accr$it+
 associations2  7#b7 take /eps to       
elim9ate or r$uce id5tifi$              
inconsi/5cies1 ov]lap1 or duplication   
among su* regulations & policies2 &     
7#c7 take o!r actions1 z appropriate1 to
 improve ! coord9ation ( regulations &  
policies ) respect to rese>* )          
laboratory animals4  7e7 ,docum5tation (
 p]sonnel exp5ses ,! ,secret>y %all     
cl>ify ! applicability ( ! requirem5ts  
"u ! ,(fice ( ,managem5t & ,budget      
,uni=m ,guidance = managem5t &          
c]tification sy/ems adopt$ by entities  
receiv+ ,f$]al rese>* grants ?r\gh !    
,dep>tm5t ( ,heal? & ,human ,s]vices    
reg>d+ docum5tation ( p]sonnel exp5ses1 
includ+ cl>ification ( ! ext5t to :i*   
any flexibility to su* requirem5ts      
specifi$ 9 su* ,uni=m ,guidance applies 
to entities receiv+ grants ?r\gh !      

,dep>tm5t ( ,heal? & ,human ,s]vices4   
7f7 ,rese>* policy bo>d  7#a7           
,e/abli%m5t ,n lat] ?an #a ye> aft] !   
date ( enactm5t ( ?is ,act1 ! ,director 
( ! ,(fice ( ,managem5t & ,budget %all  
e/abli% an advisory committee1 to be    
kn[n z ! ,rese>* ,policy ,bo>d 7ref]r$  
to 9 ?is subsection z ! ,bo>d71 to      
provide ! ,director & o!r memb]s ( !    
,f$]al ,gov]nm5t ) in=mation on !       
effects ( regulations relat$ to ,f$]al  
rese>* requirem5ts4  7#b7 ,memb]%ip     
7,a7 ,9 g5]al ,! ,bo>d %all include n m 
?an #aj ,f$]al memb]s1 includ+ ea* ( !  
foll[+ ,f$]al memb]s or _! designees3   
7i7 ,! ,adm9i/rator ( ! ,(fice (        
,in=mation & ,regulatory ,affairs ( !   
,(fice ( ,managem5t & ,budget4  7ii7 ,! 
,director ( ! ,(fice ( ,sci5ce &        
,te*nology ,policy4  7iii7 ,! ,secret>y 
( ,heal? & ,human ,s]vices4  7iv7 ,!    
,director ( ! ,national ,sci5ce         
,f\ndation4  7v7 ,! secret>ies &        
directors ( o!r dep>tm5ts & ag5cies t   
support or regulate sci5tific rese>*1 z 

det]m9$ by ! ,director ( ! ,(fice (     
,managem5t & ,budget4  7,b7 ,non-,f$]al 
memb]s ,! ,bo>d %all be compris$ ( n    
less ?an #i & n m ?an #ab repres5tatives
 ( academic rese>* in/itutions1 o!r     
private1 nonpr(it rese>* in/itutions1 or
 o!r nonpr(it organizations ) relevant  
exp]tise4 ,su* memb]s %all be appo9t$ by
 a =mal process1 to be e/abli%$ by !    
,director ( ! ,(fice ( ,managem5t &     
,budget1 9 consultation ) ! ,f$]al      
memb]%ip1 & t incorporates--  7i7       
nom9ation by memb]s ( ! nonpr(it        
sci5tific rese>* community1 includ+     
academic rese>* in/itutions2 &  7ii7    
proc$ures to fill memb]%ip positions    
vacat$ be=e ! end ( a memb]'s t]m4  7#c7
 ,purpose & responsibilities ,! ,bo>d   
%all make recomm5dations reg>d+ !       
modification & h>monization (           
regulations & policies hav+ simil>      
purposes across rese>* fund+ ag5cies to 
ensure t ! adm9i/rative burd5 ( su*     
rese>* policy & regulation is m9imiz$ to
 ! greate/ ext5t possible & consi/5t )  

ma9ta9+ responsible ov]sight ( f$]ally  
fund$ rese>*4 ,activities ( ! ,bo>d may 
include--  7,a7 provid+ ?or\gh & in=m$  
analysis ( regulations & policies2  7,b7
 id5tify+ negative or adv]se consequ5ces
 ( exi/+ policies & mak+ actionable     
recomm5dations reg>d+ possible          
improvem5t ( su* policies2  7,c7 mak+   
recomm5dations ) respect to ef=ts )9 !  
,f$]al ,gov]nm5t to improve coord9ation 
( regulation & policy relat$ to rese>*2 
7,d7 creat+ a =um = ! discussion (      
rese>* policy or regulatory gaps1       
*all5ges1 cl>ification1 or h>monization 
( su* policies or regulation1 & be/     
practices2 &  7,e7 conduct+ ongo+       
assessm5t & evaluation ( regulatory     
burd51 includ+ developm5t ( metrics1    
p]iodic measurem5t1 & id5tification (   
process improvem5ts & policy *anges4    
7#d7 ,exp]t subcommittees ,! ,bo>d may  
=m tempor>y exp]t subcommittees1 z      
appropriate1 to develop timely analysis 
on press+ issues & assi/ ! ,bo>d 9      
anticipat+ future regulatory *all5ges1  

includ+ ^? em]g+ f new sci5tific        
advances4  7#e7 ,report+ requirem5ts ,n 
lat] ?an #b ye>s aft] ! date ( enactm5t 
( ?is ,act1 & once !reaft]1 ! ,bo>d %all
 submit a report to ! ,director ( !     
,(fice ( ,managem5t & ,budget1 !        
,adm9i/rator ( ! ,(fice ( ,in=mation &  
,regulatory ,affairs ( ! ,(fice (       
,managem5t & ,budget1 ! ,director ( !   
,(fice ( ,sci5ce & ,te*nology ,policy1 !
 heads ( relevant ,f$]al dep>tm5ts &    
ag5cies1 ! ,committee on ,heal?1        
,education1 ,labor1 & ,p5sions ( !      
,s5ate1 & ! ,committee on ,en]gy &      
,comm]ce ( ! ,h\se ( ,repres5tatives    
conta9+ =mal recomm5dations on !        
conceptualization1 developm5t1          
h>monization1 & reconsid]ation (        
sci5tific rese>* policy1 includ+ !      
regulatory b5efits & burd5s4  7#f7      
,sunset ,! ,bo>d %all t]m9ate on        
,septemb] #cj1 #bjbj4  7#g7 ,,gao report
 ,n lat] ?an #d ye>s aft] ! date (      
enactm5t ( ?is ,act1 ! ,comptroll]      
,g5]al ( ! ,unit$ ,/ates %all conduct an

 indep5d5t evaluation ( ! activities    
c>ri$ out by ! ,bo>d pursuant to ?is    
subsection & submit to ! appropriate    
committees ( ,congress a report reg>d+ !
 results ( ! indep5d5t evaluation4 ,su* 
report %all review & assess ! ,bo>d's   
activities ) respect to !               
responsibilities describ$ 9 p>agraph    
7#c74  #d4 ,reimbursem5t = rese>*       
sub/ances & liv+ organisms ,section #cja
 ( ! ,public ,heal? ,s]vice ,act 7#db   
,u4,s4,c4 #bda7 is am5d$-- 7#a7 9 ! flu%
 matt] at ! end ( subsection 7a7--  7,a7
 by r$esignat+ su* matt] z subsection   
7f77#a72 &  7,b7 by mov+ su* matt] s z  
to appe> at ! end ( su* section2 &  7#b7
 9 subsection 7f7 7z s r$esignat$71 by  
add+ at ! end ! foll[+3  7#b7 ,:]e      
rese>* sub/ances & liv+ organisms are   
made available "u p>agraph 7#a7 ?r\gh   
contractors1 ! ,secret>y may direct su* 
contractors to collect paym5ts on behalf
 ( ! ,secret>y = ! co/s incurr$ to make 
available su* sub/ances & organisms & to
 =w>d am\nts s collect$ to ! ,secret>y1 

9 ! "t & mann] specifi$ by ! ,secret>y4 
7#c7 ,am\nts collect$ "u p>agraph 7#b7  
%all be cr$it$ to ! appropriations      
acc\nts t incurr$ ! co/s to make        
available ! rese>* sub/ances & liv+     
organisms involv$1 & %all rema9         
available until exp5d$ = c>ry+ out      
activities "u su* acc\nts4  4  #e4      
,/reaml9+ ,,nih report+ requirem5ts  7a7
 ,trans-,,nih rese>* report+ ,section   
#djb;,a7c77#b7 ( ! ,public ,heal?       
,s]vice ,act 7#db ,u4,s4,c4             
#bhb;a7c77#b77 is am5d$-- 7#a7 by am5d+ 
subp>agraph 7,b7 to read z foll[s3  7,b7
 ,report+ ,n lat] ?an #b ye>s aft] !    
date ( enactm5t ( ,promot+ ,biom$ical   
,rese>* & ,public ,heal? = ,pati5ts     
,act1 ! head ( ea* national rese>*      
in/itute or national c5t] %all submit to
 ! ,director ( ,,nih a report1 to be    
includ$ 9 ! tri5nial report "u section  
#djc1 on ! am\nt made available by !    
in/itute or c5t] = conduct+ or support+ 
rese>* t involves collaboration betwe5 !
 in/itute or c5t] & #a or m o!r national

 rese>* in/itutes or national c5t]s4  2 
&  7#b7 9 subp>agraphs 7,d7 & 7,e7 by   
/rik+ 7,b77i7 ea* place x appe>s &      
ins]t+ 7,b74  7b7 ,fraud & abuse report+
 ,section #djc;,b ( ! ,public ,heal?    
,s]vice ,act 7#db ,u4,s4,c4 #bhc;a-#a7  
is am5d$--  7#a7 by /rik+ subsection    
7b72  7#b7 by r$esignat+ subsection 7c7 
z subsection 7b72 &  7#c7 9 subsection  
7b7 7z s r$esignat$71 by /rik+          
subsections 7a7 & 7b7 & ins]t+          
subsection 7a74  7c7 ,doctoral degrees  
report+ ,section #djc;,c7a77#b7 ( !     
,public ,heal? ,s]vice ,act 7#db        
,u4,s4,c4 #bhc;a-#b7;a77#b77 is am5d$ by
 /rik+ 7n includ+ any leaves ( abs5ce74 
7d7 ,vacc9e report+ ,section #djd;,b ( !
 ,public ,heal? ,s]vice ,act 7#db       
,u4,s4,c4 #bhc;d7 is am5d$-- 7#a7 by    
/rik+ subsection 7b72 &  7#b7 by /rik+  
7a7 ,developm5t ( ,new ,vacc9es4--,!    
,secret>y & ins]t+ ,! ,secret>y4  7e7   
,national ,c5t] = ,advanc+              
,translational ,sci5ces ,section        
#dgi7;c7 ( ! ,public ,heal? ,s]vice ,act

 7#db ,u4,s4,c4 #bhg7;c77 is am5d$--    
7#a7 9 ! subsection head+1 by /rik+     
,annual & ins]t+ ,bi5nial2 &  7#b7 9 !  
matt] prec$+ p>agraph 7#a71 by /rik+ an 
annual report & ins]t+ a report on a    
bi5nial basis4  7f7 ,review ( c5t]s (   
excell5ce  7#a7 ,repeal ,section #djd;,h
 ( ! ,public ,heal? ,s]vice ,act 7#db   
,u4,s4,c4 #bhc;j7 is repeal$4  7#b7     
,con=m+ am5dm5t ,section #cii;,,ee7c7 ( 
! ,public ,heal? ,s]vice ,act 7#db      
,u4,s4,c4 #bhj;i-#d7;c77 is am5d$ by    
/rik+ #cii;,,cc1 #djd;,h1 & ins]t+      
#cii;,,cc4  7g7 ,rapid ,,hiv te/ report 
,section #ejb7;a7 ( ! ,ryan ,:ite ,,c>e 
,act ,am5dm5ts ( #bjjj 7#db ,u4,s4,c4   
#cjj;cc note7 is am5d$--  7#a7 by /rik+ 
p>agraph 7#b72 &  7#b7 by r$esignat+    
p>agraph 7#c7 z p>agraph 7#b74  7h7     
,bi5nial report  7#a7 ,repeal ,section  
#dfd,y ( ! ,public ,heal? ,s]vice ,act  
7#db ,u4,s4,c4 #bheq-#c7 is repeal$4    
7#b7 ,con=m+ am5dm5t ,section #dfd,x7g7 
( ! ,public ,heal? ,s]vice ,act 7#db    
,u4,s4,c4 #bheq-#b7;g77 is am5d$ by     

/rik+ bi5nial report made "u section    
#dfd,y1 & ins]t+ tri5nial report made "u
 section #djc4  #f4 ,national ,vacc9e   
,injury ,comp5sation ,program  7a7      
,additional vacc9es ,section #baad7;e7 (
 ! ,public ,heal? ,s]vice ,act 7#db     
,u4,s4,c4 #cjj;aa-#ad7;e77 is am5d$ by  
add+ at ! end ! foll[+3  7#c7 ,vacc9es  
recomm5d$ = use 9 pregnant wom5 ,!      
,secret>y %all revise ! ,vacc9e ,injury 
,table includ$ 9 subsection 7a71 ?r\gh !
 process describ$ 9 subsection 7c71 to  
include vacc9es recomm5d$ by ! ,c5t]s = 
,disease ,control & ,prev5tion = r\t9e  
adm9i/ration 9 pregnant wom5 & !        
in=mation describ$ 9 subp>agraphs 7,b7 &
 7,c7 ( p>agraph 7#b7 ) respect to su*  
vacc9es4  4  7b7 ,petition cont5t       
,section #baaa ( ! ,public ,heal?       
,s]vice ,act 7#db ,u4,s4,c4 #cjj;aa-#aa7
 is am5d$ by add+ at ! end ! foll[+3    
7f7 ,mat]nal immunization  7#a7 ,9 g5]al
 ,not)/&+ any o!r provision ( law1 =    
purposes ( ?is subtitle1 bo? a woman :o 
receiv$ a cov]$ vacc9e :ile pregnant &  

any *ild :o 0 9 ut]o at ! "t su* woman  
receiv$ ! vacc9e %all be consid]$ p]sons
 to :om ! cov]$ vacc9e 0 adm9i/]$ &     
p]sons :o receiv$ ! cov]$ vacc9e4  7#b7 
,def9ition ,z us$ 9 ?is subsection1 !   
t]m *ild %all h ! mean+ giv5 t t]m by   
subsections 7a7 & 7b7 ( section #h (    
title #a1 ,unit$ ,/ates ,code1 except t1
 = purposes ( ?is subsection1 su*       
section #h %all be appli$ z if ! t]m    
include 9 subsection 7a7 ( su* section 7
 replac$ ) ! t]m mean4  4  7c7          
,petition]s ,section #baaa7;b77#b7 ( !  
,public ,heal? ,s]vice ,act 7#db        
,u4,s4,c4 #cjj;aa-#aa7;b77#b77 is am5d$ 
by add+ ,a cov]$ vacc9e adm9i/]$ to a   
pregnant woman %all con/itute m ?an "o  
adm9i/ration1 "o to ! "m & "o to ea*    
*ild 7z su* t]m is def9$ 9 subsection   
7f77#b77 :o 0 9 ut]o at ! "t su* woman 0
 adm9i/]$ ! vacc9e4 at ! end4  #g4      
,vacc9e meet+s2 report on vacc9e        
innovation  7a7 ,vacc9e meet+s ,!       
,director ( ! ,c5t]s = ,disease ,control
 & ,prev5tion %all ensure t appropriate 

/aff )9 ! relevant c5t]s & divisions ( !
 ,(fice ( ,infecti\s ,diseases1 & o!rs1 
z appropriate1 coord9ate ) respect to ! 
public heal? ne$s1 epidemiology1 &      
program plann+ & implem5tation          
consid]ations relat$ to immunization1   
includ+ ) reg>d to meet+s ) /akehold]s  
relat$ to su* topics4  7b7 ,report on   
vacc9e innovation  7#a7 ,9 g5]al ,n lat]
 ?an #a ye> aft] ! date ( enactm5t ( ?is
 ,act1 ! ,secret>y ( ,heal? & ,human    
,s]vices 7ref]r$ to 9 ?is section z !   
,secret>y71 9 collaboration )           
appropriate ag5cies or (fices )9 !      
,dep>tm5t ( ,heal? & ,human ,s]vices1   
includ+ ! ,national ,in/itute ( ,all]gy 
& ,infecti\s ,diseases & ! ,biom$ical   
,advanc$ ,rese>* & ,developm5t          
,au?ority1 %all issue to ! ,committee on
 ,heal?1 ,education1 ,labor1 & ,p5sions 
( ! ,s5ate & ! ,committee on ,en]gy &   
,comm]ce ( ! ,h\se ( ,repres5tatives1 & 
po/ publicly on ! ,int]net website ( !  
,dep>tm5t ( ,heal? & ,human ,s]vices1 a 
report on ways to promote innovation 9 !

 developm5t ( vacc9es t m9imize ! burd5 
( infecti\s disease4  7#b7 ,cont5ts ,!  
report describ$ 9 p>agraph 7#a7 %all    
review ! curr5t /atus ( vacc9e          
developm5t &1 z appropriate--  7,a7     
consid] ! optimal process to det]m9e :i*
 vacc9es w\ld be b5eficial & h[         
in=mation on su* vacc9es is dissem9at$  
to key /akehold]s2  7,b7 exam9e &       
id5tify :e!r ob/acles exi/ t inhibit !  
developm5t ( b5eficial vacc9es2 &  7,c7 
make recomm5dations ab\t h[ be/ to      
remove any ob/acles id5tifi$ "u         
subp>agraph 7,b7 9 ord] to promote &    
inc5tivize vacc9e innovation &          
developm5t4  7#c7 ,consultation ,9      
prep>+ ! report "u subsection 7a71 !    
,secret>y may consult )-- 7,a7          
repres5tatives ( relevant ,f$]al ag5cies
 & dep>tm5ts1 includ+ ! ,dep>tm5t (     
,def5se & ! ,dep>tm5t ( ,vet]ans        
,affairs2  7,b7 academic rese>*]s2  7,c7
 develop]s & manufactur]s ( vacc9es2    
7,d7 m$ical & public heal? practition]s2
  7,e7 repres5tatives ( pati5t1 policy1 

& advocacy organizations2 &  7,f7       
repres5tatives ( o!r entities1 z !      
,secret>y det]m9es appropriate4  #h4    
,te*nical updates to cl9ical trials     
database ,section #djb7;j77#b77;,d7 ( ! 
,public ,heal? ,s]vice ,act 7#db        
,u4,s4,c4 #bhb7;j77#b77;,d77 is am5d$-- 
7#a7 9 clause 7ii77,i71 by ins]t+ be=e !
 semicolon 1 unless ! responsible p>ty  
affirmatively reque/s t ! ,director (   
,,nih publicly po/ su* cl9ical trial    
in=mation = an applicable device cl9ical
 trial prior to su* date ( cle>ance or  
approval2 &  7#b7 by add+ at ! end !    
foll[+3  7iii7 ,option to make c]ta9    
cl9ical trial in=mation available e>li] 
,! ,director ( ,,nih %all in=m          
responsible p>ties ( ! option to reque/ 
t cl9ical trial in=mation = an          
applicable device cl9ical trial be      
publicly po/$ prior to ! date ( cle>ance
 or approval1 9 accordance ) clause     
7ii77,i74  7iv7 ,comb9ation products ,an
 applicable cl9ical trial = a product t 
is a comb9ation ( drug1 device1 or      

biological product %all be consid]$--   
7,i7 an applicable drug cl9ical trial1  
if ! ,secret>y det]m9es "u section      
#ejc7;g7 ( ! ,f$]al ,food1 ,drug1 &     
,cosmetic ,act t ! prim>y mode ( action 
( su* product is t ( a drug or          
biological product2 or  7,,ii7 an       
applicable device cl9ical trial1 if !   
,secret>y det]m9es "u su* section t !   
prim>y mode ( action ( su* product is t 
( a device4  4  #i4 ,compliance         
activities reports  7a7 ,def9itions ,9  
?is section3 7#a7 ,applicable cl9ical   
trial ,! t]m applicable cl9ical trial   
has ! mean+ giv5 ! t]m 9 section        
#djb7;j7 ( ! ,public ,heal? ,s]vice ,act
 7#db ,u4,s4,c4 #bhb7;j774  7#b7        
,director ( ,,nih ,! t]m ,director (    
,,nih means ! ,director ( ! ,national   
,in/itutes ( ,heal?4  7#c7 ,secret>y ,! 
t]m ,secret>y means ! ,secret>y ( ,heal?
 & ,human ,s]vices4  7b7 ,report on     
activities ,to enc\rage compliance ,n   
lat] ?an #b ye>s aft] ! date ( enactm5t 
( ?is ,act1 ! ,secret>y1 act+ ?r\gh !   

,director ( ,,nih & 9 collaboration ) ! 
,commission] ( ,food & ,drugs1 %all     
submit to ! ,committee on ,heal?1       
,education1 ,labor1 & ,p5sions ( !      
,s5ate & ! ,committee on ,en]gy &       
,comm]ce ( ! ,h\se ( ,repres5tatives1 a 
report t describes education & outrea*1 
guidance1 en=cem5t1 & o!r activities    
und]tak5 to enc\rage compliance )       
section #djb7;j7 ( ! ,public ,heal?     
,s]vice ,act 7#db ,u4,s4,c4 #bhb7;j774  
7c7 ,reports on cl9ical trials  7#a7 ,9 
g5]al ,n lat] ?an #b ye>s aft] ! f9al   
compliance date "u ! f9al rule implem5t+
 section #djb7;j7 ( ! ,public ,heal?    
,s]vice ,act1 & e #b ye>s !reaft] = !   
next #d ye>s1 ! ,secret>y1 act+ ?r\gh ! 
,director ( ,,nih & 9 collaboration ) ! 
,commission] ( ,food & ,drugs1 %all     
submit to ! ,committee on ,heal?1       
,education1 ,labor1 & ,p5sions ( !      
,s5ate & ! ,committee on ,en]gy &       
,comm]ce ( ! ,h\se ( ,repres5tatives1 a 
report describ+--  7,a7 ! total numb] ( 
applicable cl9ical trials ) complete    

data bank regi/ration in=mation regi/]$ 
dur+ ! p]iod = :i* ! report is be+      
prep>$ 7brok5 d[n by ea* ye> ( su*      
report+ p]iod72  7,b7 ! total numb] (   
applicable cl9ical trials regi/]$ dur+ !
 p]iod = :i* ! report is be+ prep>$ =   
:i* results h be5 submitt$ to ! data    
bank 7brok5 d[n by ea* ye> ( su* report+
 p]iod72  7,c7 ! activities und]tak5 by 
! ,secret>y dur+ ! p]iod = :i* ! report 
is be+ prep>$ to educate responsible    
p]sons ab\t data bank regi/ration &     
results submission requirem5ts1 includ+ 
?r\gh issuance ( guidance docum5ts1     
in=mational meet+s1 & tra9+ sessions2 & 
7,d7 ! activities describ$ 9 ! report   
submitt$ "u subsection 7b74  7#b7       
,actions to en=ce compliance ,aft] !    
,secret>y has und]tak5 ! educational    
activities describ$ 9 p>agraph          
7#a77;,c71 ! ,secret>y %all include 9   
subsequ5t reports submitt$ "u p>agraph  
7#a7 ! numb] ( actions tak5 by !        
,secret>y dur+ ! p]iod = :i* ! report is
 be+ prep>$ to en=ce compliance ) data  

bank regi/ration & results submission   
requirem5ts4  #aj4 ,appo9tm5t (         
directors ( national rese>* in/itutes & 
national c5t]s ,subsection 7a7 ( section
 #dje ( ! ,public ,heal? ,s]vice ,act   
7#db ,u4,s4,c4 #bhd7 is am5d$ z foll[s3 
7a7 ,appo9tm5t  7#a7 ,9 g5]al ,!        
,director ( ! ,national ,canc] ,in/itute
 %all be appo9t$ by ! ,presid5t & !     
,directors ( ! o!r national rese>*      
in/itutes & c5t]s %all be appo9t$ by !  
,secret>y1 act+ ?r\gh ! ,director (     
,,nih4 ,ea* ,director ( a national      
rese>* in/itute or national c5t] %all   
report directly to ! ,director ( ,,nih4 
7#b7 ,appo9tm5t  7,a7 ,t]m ,a ,director 
( a national rese>* in/itute or national
 c5t] :o is appo9t$ by ! ,secret>y1 act+
 ?r\gh ! ,director ( ,,nih1 %all be     
appo9t$ = #e ye>s4  7,b7 ,reappo9tm5t   
,at ! end ( ! t]m ( a ,director ( a     
national rese>* in/itute or national    
c5t]1 ! ,director may be reappo9t$4 ,!re
 %all be no limit on ! numb] ( t]ms t a 
,director may s]ve4  7,c7 ,vacancies ,if

 ! (fice ( a ,director ( a national     
rese>* in/itute or national c5t] becomes
 vacant be=e ! end ( su* ,director's    
t]m1 ! ,director appo9t$ to fill !      
vacancy %all be appo9t$ = a #e-ye> t]m  
/>t+ on ! date ( su* appo9tm5t4  7,d7   
,curr5t directors ,ea* ,director ( a    
national rese>* in/itute or national    
c5t] :o is s]v+ on ! date ( enactm5t ( !
 ,promot+ ,biom$ical ,rese>* & ,public  
,heal? = ,pati5ts ,act %all be deem$ to 
be appo9t$ = a #e-ye> t]m "u ?is        
subsection beg9n+ on su* date (         
enactm5t4  7,e7 ,rule ( con/ruction     
,no?+ 9 ?is subsection %all be con/ru$  
to limit ! ability ( ! ,director ( ,,nih
 or a ,director ( a national rese>*     
in/itute or c5t] to t]m9ate ! appo9tm5t 
( su* ,director ( a national rese>*     
in/itute or c5t] prior to ! expiration (
 su* ,director's #e-ye> t]m4  7#c7      
,nonapplication ( c]ta9 provision ,!    
re/rictions conta9$ 9 section #bjb ( !  
,dep>tm5ts ( ,labor1 ,heal? & ,human    
,s]vices1 & ,education1 & ,relat$       

,ag5cies ,appropriations ,act1 #aiic    
7,public ,law #ajb-cid2 #db ,u4,s4,c4   
#bch;f note7 relat$ to consultants &    
individual sci5ti/s appo9t$ = limit$    
p]iods ( "t %all n apply to ,directors  
appo9t$ "u ?is subsection4  4  #aa4     
,national ,c5t] = ,advanc+              
,translational ,sci5ces ,section        
#dgi7;b7 ( ! ,public ,heal? ,s]vice ,act
 7#db ,u4,s4,c4 #bhg7;b77 is am5d$--    
7#a7 9 p>agraph 7#a71 by /rik+ phase    
,,iia & ins]t+ phase ,,iib2 &  7#b7 9   
p>agraph 7#b7-- 7,a7 9 ! matt] prec$+   
subp>agraph 7,a71 by /rik+ phase ,,iib &
 ins]t+ phase ,,iii2  7,b7 9 subp>agraph
 7,a71 by /rik+ phase ,,iib & ins]t+    
phase ,,iii2  7,c7 9 subp>agraph 7,b71  
by /rik+ phase ,,iia & ins]t+ phase     
,,iib2 &  7,d7 9 subp>agraph 7,c71 by   
/rik+ phase ,,iib & ins]t+ phase ,,iii4 
#a4 ,%ort title ,?is ,act may be cit$ z 
! ,promot+ ,biom$ical ,rese>* & ,public 
,heal? = ,pati5ts ,act4  #b4 ,tri5nial  
reports ( ,director ( ,,nih ,section    
#djc ( ! ,public ,heal? ,s]vice ,act    

7#db ,u4,s4,c4 #bhc7 is am5d$-- 7#a7 9 !
 section head+1 by /rik+ ,bi5nial &     
ins]t+ ,tri5nial2 &  7#b7 9 subsection  
7a7-- 7,a7 9 ! matt] prec$+ p>agraph    
7#a71 by /rik+ bi5nial & ins]t+         
tri5nial2  7,b7 by am5d+ p>agraph 7#c7  
to read z foll[s3  7#c7 ,a description (
 intra-,,nih activities1 includ+        
id5tification ( ! p]c5tage ( funds made 
available by ea* national rese>*        
in/itute & national c5t] ) respect to   
ea* applicable fiscal ye> = conduct+ or 
support+ rese>* t involves collaboration
 betwe5 ! in/itute or c5t] & #a or m o!r
 national rese>* in/itutes or national  
c5t]s & recomm5dations = promot+        
coord9ation ( in=mation among ! c5t]s ( 
excell5ce4  2  7,c7 9 p>agraph 7#d7--   
7i7 9 subp>agraph 7,b71 by /rik+        
demographic v>iables & o!r v>iables &   
ins]t+ demographic v>iables1 includ+    
biological & social v>iables & relevant 
age categories1 & det]m9ants ( heal?2 & 
7ii7 9 subp>agraph 7,c77v7-- 7,i7 by    
/rik+ demographic v>iables & su* &      

ins]t+ demographic v>iables1 includ+    
relevant age categories1 in=mation      
submitt$ by ea* national rese>* in/itute
 & national c5t] to ! ,director ( ,,nih 
"u section #dib;,b7f71 & su*2 &  7,,ii7 
by /rik+ 7reg>d+ inclusion ( wom5 &     
m9orities 9 cl9ical rese>*7 & ins]t+ &  
o!r applicable requirem5ts reg>d+       
inclusion ( demographic gr\ps2 &  7,d7 9
 p>agraph 7#f7--  7i7 9 ! matt] prec$+  
subp>agraph 7,a71 by /rik+ ! foll[+3 &  
ins]t+ ! foll[+--2  7ii7 9 subp>agraph  
7,a7--  7,i7 by /rik+ ,an evaluation &  
ins]t+ an evaluation2 &  7,,ii7 by /rik+
 ! p]iod & ins]t+ 2 &2  7iii7 by /rik+  
subp>agraphs 7,b7 & 7,d72  7iv7 by      
r$esignat+ subp>agraph 7,c7 z           
subp>agraph 7,b72 &  7v7 9 subp>agraph  
7,b71 z r$esignat$ by clause 7iv71 by   
/rik+ ,recomm5dations & ins]t+          
recomm5dations4  #c4 ,adm9i/rative burd5
 on inve/igators  7a7 ,disclosure (     
f9ancial conflicts ( int]e/  7#a7 ,9    
g5]al ,n lat] ?an #b ye>s aft] ! date ( 
enactm5t ( ?is ,act1 ! ,secret>y (      

,heal? & ,human ,s]vices 7ref]r$ to 9   
?is section z ! ,secret>y7 %all--  7,a7 
lead a review by rese>* fund+ ag5cies ( 
all regulations & policies relat$ to !  
disclosure ( f9ancial conflicts (       
int]e/1 includ+ ! m9imum ?re%old =      
report+ f9ancial conflicts ( int]e/2 &  
7,b7 make revisions1 z appropriate1 to  
h>monize exi/+ policies & r$uce         
adm9i/rative burd5 on rese>*]s :ile     
ma9ta9+ ! integrity & cr$ibility (      
rese>* f9d+s & protections ( human      
p>ticipants4  7#b7 ,consid]ations ,9    
updat+ policies "u p>agraph 7#a77;,b71 !
 ,secret>y %all consid]--  7,a7 modify+ 
! timel9es = ! report+ ( f9ancial       
conflicts ( int]e/ to j 9 "t in=mation  
by in/itutions receiv+ grant or         
coop]ative agreem5t fund+ f ! ,national 
,in/itutes ( ,heal?2  7,b7 ensur+ t     
f9ancial int]e/ disclosure report+      
requirem5ts are appropriate =1 &        
relevant to1 aw>ds t w directly fund    
rese>*1 :i* may include modification ( !
 def9ition ( ! t]m inve/igator2 &  7,c7 

updat+ any applicable tra9+ modules ( ! 
,national ,in/itutes ( ,heal? relat$ to 
,f$]al f9ancial int]e/ disclosure4  7b7 
,monitor+ ( subrecipi5ts ( fund+ f !    
,national ,in/itutes ( ,heal? ,!        
,director ( ! ,national ,in/itutes (    
,heal? %all implem5t measures to r$uce !
 adm9i/rative burd5s relat$ to monitor+ 
( subrecipi5ts ( grants by prim>y       
aw>dees ( fund+ f ! ,national ,in/itutes
 ( ,heal?1 :i* may incorporate f9d+s &  
recomm5dations f exi/+ & ongo+          
activities4 ,su* measures may include1 z
 appropriate--  7#a7 an exemption f     
subrecipi5t monitor+ requirem5ts1 ^u    
reque/ f ! prim>y aw>dees1 provid$ t--  
7,a7 ! subrecipi5t is subject to ,f$]al 
audit requirem5ts pursuant to ! ,uni=m  
,guidance ( ! ,(fice ( ,managem5t &     
,budget2  7,b7 ! prim>y aw>dee conducts 
a =mal or in=mal evaluation ( ea*       
subrecipi5t's risk ( noncompliance )    
,f$]al /atutes & regulations1 & !       
conditions ( ! subaw>d2 &  7,c7 su*     
exemption does n absolve ! prim>y aw>dee

 ( liability = misconduct by            
subrecipi5ts2 &  7#b7 ! implem5tation ( 
alt]native grant /ructures t obviate !  
ne$ = subrecipi5t monitor+1 :i* may     
include collaborative grant models all[+
 = multiple prim>y aw>dees4  7c7        
,report+ ( f9ancial exp5ditures ,!      
,secret>y1 9 consultation ) ! ,director 
( ! ,national ,in/itutes ( ,heal?1 %all 
evaluate f9ancial exp5diture report+    
proc$ures & requirem5ts = recipi5ts (   
fund+ f ! ,national ,in/itutes ( ,heal? 
& take action1 z appropriate1 to avoid  
duplication betwe5 dep>tm5t & ag5cy     
proc$ures & requirem5ts & m9imize burd5 
to fund+ recipi5ts4  7d7 ,animal c>e &  
use 9 rese>* ,n lat] ?an #b ye>s aft] ! 
date ( enactm5t ( ?is ,act1 ! ,director 
( ! ,national ,in/itutes ( ,heal?1 9    
collaboration ) ! ,secret>y (           
,agriculture & ! ,commission] ( ,food & 
,drugs1 %all complete a review (        
applicable regulations & policies = !   
c>e & use ( laboratory animals & make   
revisions1 z appropriate1 to r$uce      

adm9i/rative burd5 on inve/igators :ile 
ma9ta9+ ! integrity & cr$ibility (      
rese>* f9d+s & protection ( rese>*      
animals4 ,9 c>ry+ out ?is ef=t1 !       
,director %all seek ! input ( exp]ts1 z 
appropriate4 ,! ,director %all--  7#a7  
id5tify ways to ensure su* regulations &
 policies are n inconsi/5t1 ov]lapp+1 or
 unnecess>ily duplicative1 includ+ )    
respect to inspection & review          
requirem5ts by ,f$]al ag5cies & accr$it+
 associations2  7#b7 take /eps to       
elim9ate or r$uce id5tifi$              
inconsi/5cies1 ov]lap1 or duplication   
among su* regulations & policies2 &     
7#c7 take o!r actions1 z appropriate1 to
 improve ! coord9ation ( regulations &  
policies ) respect to rese>* )          
laboratory animals4  7e7 ,docum5tation (
 p]sonnel exp5ses ,! ,secret>y %all     
cl>ify ! applicability ( ! requirem5ts  
"u ! ,(fice ( ,managem5t & ,budget      
,uni=m ,guidance = managem5t &          
c]tification sy/ems adopt$ by entities  
receiv+ ,f$]al rese>* grants ?r\gh !    

,dep>tm5t ( ,heal? & ,human ,s]vices    
reg>d+ docum5tation ( p]sonnel exp5ses1 
includ+ cl>ification ( ! ext5t to :i*   
any flexibility to su* requirem5ts      
specifi$ 9 su* ,uni=m ,guidance applies 
to entities receiv+ grants ?r\gh !      
,dep>tm5t ( ,heal? & ,human ,s]vices4   
7f7 ,rese>* policy bo>d  7#a7           
,e/abli%m5t ,n lat] ?an #a ye> aft] !   
date ( enactm5t ( ?is ,act1 ! ,director 
( ! ,(fice ( ,managem5t & ,budget %all  
e/abli% an advisory committee1 to be    
kn[n z ! ,rese>* ,policy ,bo>d 7ref]r$  
to 9 ?is subsection z ! ,bo>d71 to      
provide ! ,director & o!r memb]s ( !    
,f$]al ,gov]nm5t ) in=mation on !       
effects ( regulations relat$ to ,f$]al  
rese>* requirem5ts4  7#b7 ,memb]%ip     
7,a7 ,9 g5]al ,! ,bo>d %all include n m 
?an #aj ,f$]al memb]s1 includ+ ea* ( !  
foll[+ ,f$]al memb]s or _! designees3   
7i7 ,! ,adm9i/rator ( ! ,(fice (        
,in=mation & ,regulatory ,affairs ( !   
,(fice ( ,managem5t & ,budget4  7ii7 ,! 
,director ( ! ,(fice ( ,sci5ce &        

,te*nology ,policy4  7iii7 ,! ,secret>y 
( ,heal? & ,human ,s]vices4  7iv7 ,!    
,director ( ! ,national ,sci5ce         
,f\ndation4  7v7 ,! secret>ies &        
directors ( o!r dep>tm5ts & ag5cies t   
support or regulate sci5tific rese>*1 z 
det]m9$ by ! ,director ( ! ,(fice (     
,managem5t & ,budget4  7,b7 ,non-,f$]al 
memb]s ,! ,bo>d %all be compris$ ( n    
less ?an #i & n m ?an #ab repres5tatives
 ( academic rese>* in/itutions1 o!r     
private1 nonpr(it rese>* in/itutions1 or
 o!r nonpr(it organizations ) relevant  
exp]tise4 ,su* memb]s %all be appo9t$ by
 a =mal process1 to be e/abli%$ by !    
,director ( ! ,(fice ( ,managem5t &     
,budget1 9 consultation ) ! ,f$]al      
memb]%ip1 & t incorporates--  7i7       
nom9ation by memb]s ( ! nonpr(it        
sci5tific rese>* community1 includ+     
academic rese>* in/itutions2 &  7ii7    
proc$ures to fill memb]%ip positions    
vacat$ be=e ! end ( a memb]'s t]m4  7#c7
 ,purpose & responsibilities ,! ,bo>d   
%all make recomm5dations reg>d+ !       

modification & h>monization (           
regulations & policies hav+ simil>      
purposes across rese>* fund+ ag5cies to 
ensure t ! adm9i/rative burd5 ( su*     
rese>* policy & regulation is m9imiz$ to
 ! greate/ ext5t possible & consi/5t )  
ma9ta9+ responsible ov]sight ( f$]ally  
fund$ rese>*4 ,activities ( ! ,bo>d may 
include--  7,a7 provid+ ?or\gh & in=m$  
analysis ( regulations & policies2  7,b7
 id5tify+ negative or adv]se consequ5ces
 ( exi/+ policies & mak+ actionable     
recomm5dations reg>d+ possible          
improvem5t ( su* policies2  7,c7 mak+   
recomm5dations ) respect to ef=ts )9 !  
,f$]al ,gov]nm5t to improve coord9ation 
( regulation & policy relat$ to rese>*2 
7,d7 creat+ a =um = ! discussion (      
rese>* policy or regulatory gaps1       
*all5ges1 cl>ification1 or h>monization 
( su* policies or regulation1 & be/     
practices2 &  7,e7 conduct+ ongo+       
assessm5t & evaluation ( regulatory     
burd51 includ+ developm5t ( metrics1    
p]iodic measurem5t1 & id5tification (   

process improvem5ts & policy *anges4    
7#d7 ,exp]t subcommittees ,! ,bo>d may  
=m tempor>y exp]t subcommittees1 z      
appropriate1 to develop timely analysis 
on press+ issues & assi/ ! ,bo>d 9      
anticipat+ future regulatory *all5ges1  
includ+ ^? em]g+ f new sci5tific        
advances4  7#e7 ,report+ requirem5ts ,n 
lat] ?an #b ye>s aft] ! date ( enactm5t 
( ?is ,act1 & once !reaft]1 ! ,bo>d %all
 submit a report to ! ,director ( !     
,(fice ( ,managem5t & ,budget1 !        
,adm9i/rator ( ! ,(fice ( ,in=mation &  
,regulatory ,affairs ( ! ,(fice (       
,managem5t & ,budget1 ! ,director ( !   
,(fice ( ,sci5ce & ,te*nology ,policy1 !
 heads ( relevant ,f$]al dep>tm5ts &    
ag5cies1 ! ,committee on ,heal?1        
,education1 ,labor1 & ,p5sions ( !      
,s5ate1 & ! ,committee on ,en]gy &      
,comm]ce ( ! ,h\se ( ,repres5tatives    
conta9+ =mal recomm5dations on !        
conceptualization1 developm5t1          
h>monization1 & reconsid]ation (        
sci5tific rese>* policy1 includ+ !      

regulatory b5efits & burd5s4  7#f7      
,sunset ,! ,bo>d %all t]m9ate on        
,septemb] #cj1 #bjbj4  7#g7 ,,gao report
 ,n lat] ?an #d ye>s aft] ! date (      
enactm5t ( ?is ,act1 ! ,comptroll]      
,g5]al ( ! ,unit$ ,/ates %all conduct an
 indep5d5t evaluation ( ! activities    
c>ri$ out by ! ,bo>d pursuant to ?is    
subsection & submit to ! appropriate    
committees ( ,congress a report reg>d+ !
 results ( ! indep5d5t evaluation4 ,su* 
report %all review & assess ! ,bo>d's   
activities ) respect to !               
responsibilities describ$ 9 p>agraph    
7#c74  #d4 ,reimbursem5t = rese>*       
sub/ances & liv+ organisms ,section #cja
 ( ! ,public ,heal? ,s]vice ,act 7#db   
,u4,s4,c4 #bda7 is am5d$-- 7#a7 9 ! flu%
 matt] at ! end ( subsection 7a7--  7,a7
 by r$esignat+ su* matt] z subsection   
7f77#a72 &  7,b7 by mov+ su* matt] s z  
to appe> at ! end ( su* section2 &  7#b7
 9 subsection 7f7 7z s r$esignat$71 by  
add+ at ! end ! foll[+3  7#b7 ,:]e      
rese>* sub/ances & liv+ organisms are   

made available "u p>agraph 7#a7 ?r\gh   
contractors1 ! ,secret>y may direct su* 
contractors to collect paym5ts on behalf
 ( ! ,secret>y = ! co/s incurr$ to make 
available su* sub/ances & organisms & to
 =w>d am\nts s collect$ to ! ,secret>y1 
9 ! "t & mann] specifi$ by ! ,secret>y4 
7#c7 ,am\nts collect$ "u p>agraph 7#b7  
%all be cr$it$ to ! appropriations      
acc\nts t incurr$ ! co/s to make        
available ! rese>* sub/ances & liv+     
organisms involv$1 & %all rema9         
available until exp5d$ = c>ry+ out      
activities "u su* acc\nts4  4  #e4      
,/reaml9+ ,,nih report+ requirem5ts  7a7
 ,trans-,,nih rese>* report+ ,section   
#djb;,a7c77#b7 ( ! ,public ,heal?       
,s]vice ,act 7#db ,u4,s4,c4             
#bhb;a7c77#b77 is am5d$-- 7#a7 by am5d+ 
subp>agraph 7,b7 to read z foll[s3  7,b7
 ,report+ ,n lat] ?an #b ye>s aft] !    
date ( enactm5t ( ,promot+ ,biom$ical   
,rese>* & ,public ,heal? = ,pati5ts     
,act1 ! head ( ea* national rese>*      
in/itute or national c5t] %all submit to

 ! ,director ( ,,nih a report1 to be    
includ$ 9 ! tri5nial report "u section  
#djc1 on ! am\nt made available by !    
in/itute or c5t] = conduct+ or support+ 
rese>* t involves collaboration betwe5 !
 in/itute or c5t] & #a or m o!r national
 rese>* in/itutes or national c5t]s4  2 
&  7#b7 9 subp>agraphs 7,d7 & 7,e7 by   
/rik+ 7,b77i7 ea* place x appe>s &      
ins]t+ 7,b74  7b7 ,fraud & abuse report+
 ,section #djc;,b ( ! ,public ,heal?    
,s]vice ,act 7#db ,u4,s4,c4 #bhc;a-#a7  
is am5d$--  7#a7 by /rik+ subsection    
7b72  7#b7 by r$esignat+ subsection 7c7 
z subsection 7b72 &  7#c7 9 subsection  
7b7 7z s r$esignat$71 by /rik+          
subsections 7a7 & 7b7 & ins]t+          
subsection 7a74  7c7 ,doctoral degrees  
report+ ,section #djc;,c7a77#b7 ( !     
,public ,heal? ,s]vice ,act 7#db        
,u4,s4,c4 #bhc;a-#b7;a77#b77 is am5d$ by
 /rik+ 7n includ+ any leaves ( abs5ce74 
7d7 ,vacc9e report+ ,section #djd;,b ( !
 ,public ,heal? ,s]vice ,act 7#db       
,u4,s4,c4 #bhc;d7 is am5d$-- 7#a7 by    

/rik+ subsection 7b72 &  7#b7 by /rik+  
7a7 ,developm5t ( ,new ,vacc9es4--,!    
,secret>y & ins]t+ ,! ,secret>y4  7e7   
,national ,c5t] = ,advanc+              
,translational ,sci5ces ,section        
#dgi7;c7 ( ! ,public ,heal? ,s]vice ,act
 7#db ,u4,s4,c4 #bhg7;c77 is am5d$--    
7#a7 9 ! subsection head+1 by /rik+     
,annual & ins]t+ ,bi5nial2 &  7#b7 9 !  
matt] prec$+ p>agraph 7#a71 by /rik+ an 
annual report & ins]t+ a report on a    
bi5nial basis4  7f7 ,review ( c5t]s (   
excell5ce  7#a7 ,repeal ,section #djd;,h
 ( ! ,public ,heal? ,s]vice ,act 7#db   
,u4,s4,c4 #bhc;j7 is repeal$4  7#b7     
,con=m+ am5dm5t ,section #cii;,,ee7c7 ( 
! ,public ,heal? ,s]vice ,act 7#db      
,u4,s4,c4 #bhj;i-#d7;c77 is am5d$ by    
/rik+ #cii;,,cc1 #djd;,h1 & ins]t+      
#cii;,,cc4  7g7 ,rapid ,,hiv te/ report 
,section #ejb7;a7 ( ! ,ryan ,:ite ,,c>e 
,act ,am5dm5ts ( #bjjj 7#db ,u4,s4,c4   
#cjj;cc note7 is am5d$--  7#a7 by /rik+ 
p>agraph 7#b72 &  7#b7 by r$esignat+    
p>agraph 7#c7 z p>agraph 7#b74  7h7     

,bi5nial report  7#a7 ,repeal ,section  
#dfd,y ( ! ,public ,heal? ,s]vice ,act  
7#db ,u4,s4,c4 #bheq-#c7 is repeal$4    
7#b7 ,con=m+ am5dm5t ,section #dfd,x7g7 
( ! ,public ,heal? ,s]vice ,act 7#db    
,u4,s4,c4 #bheq-#b7;g77 is am5d$ by     
/rik+ bi5nial report made "u section    
#dfd,y1 & ins]t+ tri5nial report made "u
 section #djc4  #f4 ,national ,vacc9e   
,injury ,comp5sation ,program  7a7      
,additional vacc9es ,section #baad7;e7 (
 ! ,public ,heal? ,s]vice ,act 7#db     
,u4,s4,c4 #cjj;aa-#ad7;e77 is am5d$ by  
add+ at ! end ! foll[+3  7#c7 ,vacc9es  
recomm5d$ = use 9 pregnant wom5 ,!      
,secret>y %all revise ! ,vacc9e ,injury 
,table includ$ 9 subsection 7a71 ?r\gh !
 process describ$ 9 subsection 7c71 to  
include vacc9es recomm5d$ by ! ,c5t]s = 
,disease ,control & ,prev5tion = r\t9e  
adm9i/ration 9 pregnant wom5 & !        
in=mation describ$ 9 subp>agraphs 7,b7 &
 7,c7 ( p>agraph 7#b7 ) respect to su*  
vacc9es4  4  7b7 ,petition cont5t       
,section #baaa ( ! ,public ,heal?       

,s]vice ,act 7#db ,u4,s4,c4 #cjj;aa-#aa7
 is am5d$ by add+ at ! end ! foll[+3    
7f7 ,mat]nal immunization  7#a7 ,9 g5]al
 ,not)/&+ any o!r provision ( law1 =    
purposes ( ?is subtitle1 bo? a woman :o 
receiv$ a cov]$ vacc9e :ile pregnant &  
any *ild :o 0 9 ut]o at ! "t su* woman  
receiv$ ! vacc9e %all be consid]$ p]sons
 to :om ! cov]$ vacc9e 0 adm9i/]$ &     
p]sons :o receiv$ ! cov]$ vacc9e4  7#b7 
,def9ition ,z us$ 9 ?is subsection1 !   
t]m *ild %all h ! mean+ giv5 t t]m by   
subsections 7a7 & 7b7 ( section #h (    
title #a1 ,unit$ ,/ates ,code1 except t1
 = purposes ( ?is subsection1 su*       
section #h %all be appli$ z if ! t]m    
include 9 subsection 7a7 ( su* section 7
 replac$ ) ! t]m mean4  4  7c7          
,petition]s ,section #baaa7;b77#b7 ( !  
,public ,heal? ,s]vice ,act 7#db        
,u4,s4,c4 #cjj;aa-#aa7;b77#b77 is am5d$ 
by add+ ,a cov]$ vacc9e adm9i/]$ to a   
pregnant woman %all con/itute m ?an "o  
adm9i/ration1 "o to ! "m & "o to ea*    
*ild 7z su* t]m is def9$ 9 subsection   

7f77#b77 :o 0 9 ut]o at ! "t su* woman 0
 adm9i/]$ ! vacc9e4 at ! end4  #g4      
,vacc9e meet+s2 report on vacc9e        
innovation  7a7 ,vacc9e meet+s ,!       
,director ( ! ,c5t]s = ,disease ,control
 & ,prev5tion %all ensure t appropriate 
/aff )9 ! relevant c5t]s & divisions ( !
 ,(fice ( ,infecti\s ,diseases1 & o!rs1 
z appropriate1 coord9ate ) respect to ! 
public heal? ne$s1 epidemiology1 &      
program plann+ & implem5tation          
consid]ations relat$ to immunization1   
includ+ ) reg>d to meet+s ) /akehold]s  
relat$ to su* topics4  7b7 ,report on   
vacc9e innovation  7#a7 ,9 g5]al ,n lat]
 ?an #a ye> aft] ! date ( enactm5t ( ?is
 ,act1 ! ,secret>y ( ,heal? & ,human    
,s]vices 7ref]r$ to 9 ?is section z !   
,secret>y71 9 collaboration )           
appropriate ag5cies or (fices )9 !      
,dep>tm5t ( ,heal? & ,human ,s]vices1   
includ+ ! ,national ,in/itutes ( ,heal?1
 ! ,c5t]s = ,disease ,control &         
,prev5tion1 & ! ,biom$ical ,advanc$     
,rese>* & ,developm5t ,au?ority1 %all   

issue to ! ,committee on ,heal?1        
,education1 ,labor1 & ,p5sions ( !      
,s5ate & ! ,committee on ,en]gy &       
,comm]ce ( ! ,h\se ( ,repres5tatives1 & 
po/ publicly on ! ,int]net website ( !  
,dep>tm5t ( ,heal? & ,human ,s]vices1 a 
report on ways to promote innovation 9 !
 developm5t ( vacc9es t m9imize ! burd5 
( infecti\s disease4  7#b7 ,cont5ts ,!  
report describ$ 9 p>agraph 7#a7 %all    
review ! curr5t /atus ( vacc9e          
developm5t &1 z appropriate--  7,a7     
consid] ! optimal process to det]m9e :i*
 vacc9es w\ld be b5eficial & h[         
in=mation on su* vacc9es is dissem9at$  
to key /akehold]s2  7,b7 exam9e &       
id5tify :e!r ob/acles exi/ t inhibit !  
developm5t ( b5eficial vacc9es2 &  7,c7 
make recomm5dations ab\t h[ be/ to      
remove any ob/acles id5tifi$ "u         
subp>agraph 7,b7 9 ord] to promote &    
inc5tivize vacc9e innovation &          
developm5t4  7#c7 ,consultation ,9      
prep>+ ! report "u ?is subsection1 !    
,secret>y may consult )-- 7,a7          

repres5tatives ( relevant ,f$]al ag5cies
 & dep>tm5ts1 includ+ ! ,dep>tm5t (     
,def5se & ! ,dep>tm5t ( ,vet]ans        
,affairs2  7,b7 academic rese>*]s2  7,c7
 develop]s & manufactur]s ( vacc9es2    
7,d7 m$ical & public heal? practition]s2
  7,e7 repres5tatives ( pati5t1 policy1 
& advocacy organizations2 &  7,f7       
repres5tatives ( o!r entities1 z !      
,secret>y det]m9es appropriate4  #h4    
,te*nical updates to cl9ical trials     
database ,section #djb7;j77#b77;,d7 ( ! 
,public ,heal? ,s]vice ,act 7#db        
,u4,s4,c4 #bhb7;j77#b77;,d77 is am5d$-- 
7#a7 9 clause 7ii77,i71 by ins]t+ be=e !
 semicolon 1 unless ! responsible p>ty  
affirmatively reque/s t ! ,director (   
,,nih publicly po/ su* cl9ical trial    
in=mation = an applicable device cl9ical
 trial prior to su* date ( cle>ance or  
approval2 &  7#b7 by add+ at ! end !    
foll[+3  7iii7 ,option to make c]ta9    
cl9ical trial in=mation available e>li] 
,! ,director ( ,,nih %all in=m          
responsible p>ties ( ! option to reque/ 

t cl9ical trial in=mation = an          
applicable device cl9ical trial be      
publicly po/$ prior to ! date ( cle>ance
 or approval1 9 accordance ) clause     
7ii77,i74  7iv7 ,comb9ation products ,an
 applicable cl9ical trial = a product t 
is a comb9ation ( drug1 device1 or      
biological product %all be consid]$--   
7,i7 an applicable drug cl9ical trial1  
if ! ,secret>y det]m9es "u section      
#ejc7;g7 ( ! ,f$]al ,food1 ,drug1 &     
,cosmetic ,act t ! prim>y mode ( action 
( su* product is t ( a drug or          
biological product2 or  7,,ii7 an       
applicable device cl9ical trial1 if !   
,secret>y det]m9es "u su* section t !   
prim>y mode ( action ( su* product is t 
( a device4  4  #i4 ,compliance         
activities reports  7a7 ,def9itions ,9  
?is section3 7#a7 ,applicable cl9ical   
trial ,! t]m applicable cl9ical trial   
has ! mean+ giv5 ! t]m 9 section        
#djb7;j7 ( ! ,public ,heal? ,s]vice ,act
 7#db ,u4,s4,c4 #bhb7;j774  7#b7        
,director ( ,,nih ,! t]m ,director (    

,,nih means ! ,director ( ! ,national   
,in/itutes ( ,heal?4  7#c7 ,secret>y ,! 
t]m ,secret>y means ! ,secret>y ( ,heal?
 & ,human ,s]vices4  7b7 ,report on     
activities to enc\rage compliance ,n    
lat] ?an #b ye>s aft] ! date ( enactm5t 
( ?is ,act1 ! ,secret>y1 act+ ?r\gh !   
,director ( ,,nih & 9 collaboration ) ! 
,commission] ( ,food & ,drugs1 %all     
submit to ! ,committee on ,heal?1       
,education1 ,labor1 & ,p5sions ( !      
,s5ate & ! ,committee on ,en]gy &       
,comm]ce ( ! ,h\se ( ,repres5tatives1 a 
report t describes education & outrea*1 
guidance1 en=cem5t1 & o!r activities    
und]tak5 to enc\rage compliance )       
section #djb7;j7 ( ! ,public ,heal?     
,s]vice ,act 7#db ,u4,s4,c4 #bhb7;j774  
7c7 ,reports on cl9ical trials  7#a7 ,9 
g5]al ,n lat] ?an #b ye>s aft] ! f9al   
compliance date "u ! f9al rule implem5t+
 section #djb7;j7 ( ! ,public ,heal?    
,s]vice ,act1 & e #b ye>s !reaft] = !   
next #d ye>s1 ! ,secret>y1 act+ ?r\gh ! 
,director ( ,,nih & 9 collaboration ) ! 

,commission] ( ,food & ,drugs1 %all     
submit to ! ,committee on ,heal?1       
,education1 ,labor1 & ,p5sions ( !      
,s5ate & ! ,committee on ,en]gy &       
,comm]ce ( ! ,h\se ( ,repres5tatives1 a 
report describ+--  7,a7 ! total numb] ( 
applicable cl9ical trials ) complete    
data bank regi/ration in=mation regi/]$ 
dur+ ! p]iod = :i* ! report is be+      
prep>$ 7brok5 d[n by ea* ye> ( su*      
report+ p]iod72  7,b7 ! total numb] (   
applicable cl9ical trials regi/]$ dur+ !
 p]iod = :i* ! report is be+ prep>$ =   
:i* results h be5 submitt$ to ! data    
bank 7brok5 d[n by ea* ye> ( su* report+
 p]iod72  7,c7 ! activities und]tak5 by 
! ,secret>y to educate responsible      
p]sons ab\t data bank regi/ration &     
results submission requirem5ts1 includ+ 
?r\gh issuance ( guidance docum5ts1     
in=mational meet+s1 & tra9+ sessions2 & 
7,d7 ! activities describ$ 9 ! report   
submitt$ "u subsection 7b74  7#b7       
,actions to en=ce compliance ,aft] !    
,secret>y has und]tak5 ! educational    

activities describ$ 9 p>agraph          
7#a77;,c71 ! ,secret>y %all include 9   
subsequ5t reports submitt$ "u p>agraph  
7#a7 ! numb] ( actions tak5 by !        
,secret>y dur+ ! p]iod = :i* ! report is
 be+ prep>$ to en=ce compliance ) data  
bank regi/ration & results submission   
requirem5ts4  #aj4 ,appo9tm5t (         
directors ( national rese>* in/itutes & 
national c5t]s ,subsection 7a7 ( section
 #dje ( ! ,public ,heal? ,s]vice ,act   
7#db ,u4,s4,c4 #bhd7 is am5d$ to read z 
foll[s3  7a7 ,appo9tm5t  7#a7 ,9 g5]al  
,! ,director ( ! ,national ,canc]       
,in/itute %all be appo9t$ by !          
,presid5t1 & ! ,directors ( ! o!r       
national rese>* in/itutes & c5t]s %all  
be appo9t$ by ! ,secret>y1 act+ ?r\gh ! 
,director ( ,,nih4 ,ea* ,director ( a   
national rese>* in/itute or national    
c5t] %all report directly to ! ,director
 ( ,,nih4  7#b7 ,appo9tm5t  7,a7 ,t]m ,a
 ,director ( a national rese>* in/itute 
or national c5t] :o is appo9t$ by !     
,secret>y1 act+ ?r\gh ! ,director (     

,,nih1 %all be appo9t$ = #e ye>s4  7,b7 
,reappo9tm5t ,at ! end ( ! t]m ( a      
,director ( a national rese>* in/itute  
or national c5t]1 ! ,director may be    
reappo9t$4 ,!re %all be no limit on !   
numb] ( t]ms t a ,director may s]ve4    
7,c7 ,vacancies ,if ! (fice ( a         
,director ( a national rese>* in/itute  
or national c5t] becomes vacant be=e !  
end ( su* ,director's t]m1 ! ,director  
appo9t$ to fill ! vacancy %all be       
appo9t$ = a #e-ye> t]m />t+ on ! date ( 
su* appo9tm5t4  7,d7 ,curr5t directors  
,ea* ,director ( a national rese>*      
in/itute or national c5t] :o is s]v+ on 
! date ( enactm5t ( ! ,promot+          
,biom$ical ,rese>* & ,public ,heal? =   
,pati5ts ,act %all be deem$ to be       
appo9t$ = a #e-ye> t]m "u ?is subsection
 beg9n+ on su* date ( enactm5t4  7,e7   
,rule ( con/ruction ,no?+ 9 ?is         
subsection %all be con/ru$ to limit !   
ability ( ! ,director ( ,,nih or a      
,director ( a national rese>* in/itute  
or c5t] to t]m9ate ! appo9tm5t ( su*    

,director ( a national rese>* in/itute  
or c5t] prior to ! expiration ( su*     
,director's #e-ye> t]m4  7#c7           
,nonapplication ( c]ta9 provision ,!    
re/rictions conta9$ 9 section #bjb ( !  
,dep>tm5ts ( ,labor1 ,heal? & ,human    
,s]vices1 & ,education1 & ,relat$       
,ag5cies ,appropriations ,act1 #aiic    
7,public ,law #ajb-cid2 #db ,u4,s4,c4   
#bch;f note7 relat$ to consultants &    
individual sci5ti/s appo9t$ = limit$    
p]iods ( "t %all n apply to ,directors  
appo9t$ "u ?is subsection4  4  #aa4     
,national ,c5t] = ,advanc+              
,translational ,sci5ces  7a7 ,9 g5]al   
,section #dgi7;b7 ( ! ,public ,heal?    
,s]vice ,act 7#db ,u4,s4,c4 #bhg7;b77 is
 am5d$-- 7#a7 9 p>agraph 7#a71 by /rik+ 
phase ,,iia & ins]t+ phase ,,iib2 &     
7#b7 9 p>agraph 7#b7-- 7,a7 9 ! matt]   
prec$+ subp>agraph 7,a71 by /rik+ phase 
,,iib & ins]t+ phase ,,iii2  7,b7 9     
subp>agraph 7,a71 by /rik+ phase ,,iib &
 ins]t+ phase ,,iii2  7,c7 9 subp>agraph
 7,b71 by /rik+ phase ,,iia & ins]t+    

phase ,,iib2 &  7,d7 9 subp>agraph 7,c71
 by /rik+ phase ,,iib & ins]t+ phase    
,,iii4  7b7 ,increas$ transp>5cy        
,section #dgi ( ! ,public ,heal? ,s]vice
 ,act 7#db ,u4,s4,c4 #bhg7 is am5d$--   
7#a7 9 subsection 7c7-- 7,a7 9 p>agraph 
7#d77;,d71 by /rik+ & at ! end2  7,b7 9 
p>agraph 7#e71 by /rik+ ! p]iod & ins]t+
 a semicolon2 &  7,c7 by add+ at ! end !
 foll[+3  7#f7 ! me?ods & tools1 if any1
 t h be5 develop$ s9ce ! la/ bi5nial    
report 0 prep>$2 &  7#g7 ! me?ods &     
tools1 if any1 t h be5 develop$ & are   
be+ utiliz$ by ! ,food & ,drug          
,adm9i/ration to support m$ical product 
reviews4  2 &  7#b7 by add+ at ! end !  
foll[+3  7d7 ,inclusion ( li/ ,! fir/   
bi5nial report submitt$ "u ?is section  
aft] ! date ( enactm5t ( ?is subsection 
%all include a complete li/ ( all ( !   
me?ods & tools1 if any1 :i* h be5       
develop$ by rese>* support$ by ! ,c5t]4 
7e7 ,rule ( con/ruction ,no?+ 9 ?is     
section %all be con/ru$ z au?oriz+ !    
,secret>y to disclose any in=mation t is

 a trade secret1 or o!r privileg$ or    
confid5tial in=mation subject to section
 #eeb7;b77#d7 ( title #e1 ,unit$ ,/ates 
,code1 or section #aije ( title #ah1    
,unit$ ,/ates ,code4  4  ,april #ah1    
#bjaf,report$ ) an am5dm5t