,,ii ,cal5d> ,no4 #dbg #aad? ,,congress 
#b;d ,session  ,s4 #bgjj  ,,9 ,,!       
,,s5ate ,,( ,,! ,,unit$ ,,/ates  ,m>*   
#ag1 #bjaf,mr4 ,alex&] 7= himself &     
,mrs4 ,murray7 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 update ! au?oriz+ provisions
 relat+ to ! work=ces ( ! ,national     
,in/itutes ( ,heal? & ! ,food & ,drug   
,adm9i/ration1 & = o!r purposes4  #a4   
,%ort title ,?is ,act may be cit$ z !   
,,fda & ,,nih ,work=ce ,au?orities      
,mod]nization ,act4  #b4 ,silvio ,o4    
,conte s5ior biom$ical rese>* s]vice    
7a7 ,hir+ & ret5tion au?ority ,section  
#bbh ( ! ,public ,heal? ,s]vice ,act    
7#db ,u4,s4,c4 #bcg7 is am5d$-- 7#a7 9 !
 section head+1 by ins]t+ & ,biom$ical  
,product ,assessm5t aft] ,rese>*2  7#b7 
9 subsection 7a7-- 7,a7 9 p>agraph 7#a71

 by /rik+ ,silvio ,o4 ,conte ,s5ior     
,biom$ical ,rese>* ,s]vice1 n to exce$  
#ejj memb]s & ins]t+ ,silvio ,o4 ,conte 
,s5ior ,biom$ical ,rese>* & ,biom$ical  
,product ,assessm5t ,s]vice 79 ?is      
section ref]r$ to z ! ,s]vice71 n to    
exce$ #b1jjj memb]s1 ! purpose ( :i* is 
to recruit & reta9 out/&+ & qualifi$    
sci5tific & te*nical exp]ts 9 ! fields (
 biom$ical rese>*1 cl9ical rese>*       
evaluation1 & biom$ical product         
assessm5t2  7,b7 by am5d+ p>agraph 7#b7 
to read z foll[s3  7#b7 ,! au?ority     
e/abli%$ 9 p>agraph 7#a7 may n be       
con/ru$ to require ! ,secret>y to r$uce 
! numb] ( employees s]v+ "u any o!r     
employm5t sy/em 9 ord] to (fset ! numb] 
( memb]s s]v+ 9 ! ,s]vice4  2 &  7,c7 by
 add+ at ! end ! foll[+3  7#c7 ,!       
,secret>y %all assign exp]ts "u ?is     
section to ag5cies )9 ! ,dep>tm5t (     
,heal? & ,human ,s]vices tak+ into      
acc\nt ! ne$ = ! exp]tise ( su* exp]t4  
2  7#c7 9 subsection 7b7-- 7,a7 9 !     
matt] prec$+ p>agraph 7#a71 by /rik+ or 

cl9ical rese>* evaluation & ins]t+ 1    
cl9ical rese>* evaluation1 or biom$ical 
product assessm5t2 &  7,b7 9 p>agraph   
7#a71 by ins]t+ or a doctoral or ma/]'s 
level degree 9 eng9e]+1 bio9=matics1 or 
a relat$ or em]g+ field1 aft] ! comma2  
7#d7 9 subsection 7d77#b71 by /rik+ &   
%all n exce$ ! rate payable = level ,i (
 ! ,executive ,s*$ule unless approv$ by 
! ,presid5t "u section #ecgg7;d77#b7 (  
title #e1 ,unit$ ,/ates ,code & ins]t+ &
 %all n exce$ ! am\nt ( annual          
comp5sation 7exclud+ exp5ses7 specifi$ 9
 section #ajb ( title #c1 ,unit$ ,/ates 
,code2  7#e7 by /rik+ subsection 7e72 & 
7#f7 by r$esignat+ subsections 7f7 & 7g7
 z subsections 7e7 & 7f71 respectively4 
7b7 ,,gao /udy  7#a7 ,9 g5]al ,!        
,comptroll] ,g5]al ( ! ,unit$ ,/ates    
%all conduct a /udy ( ! effectiv5ess ( !
 am5dm5ts to section #bbh ( ! ,public   
,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bcg7
 made by subsection 7a7 & ! impact ( su*
 am5dm5ts1 if any1 on all ag5cies or    
dep>tm5ts ( ! ,dep>tm5t ( ,heal? &      

,human ,s]vices1 &1 n lat] ?an #d ye>s  
aft] ! date ( enactm5t ( ?is ,act1 %all 
submit a report bas$ on su* /udy to !   
,committee on ,heal?1 ,education1       
,labor1 & ,p5sions ( ! ,s5ate & !       
,committee on ,en]gy & ,comm]ce ( !     
,h\se ( ,repres5tatives4  7#b7 ,cont5t (
 /udy & report ,! /udy & report "u      
p>agraph 7#a7 %all include an exam9ation
 ( ! ext5t to :i* recruitm5t & ret5tion 
( out/&+ & qualifi$ sci5tific1 m$ical1  
or te*nical exp]ts 9 ! fields (         
biom$ical rese>*1 cl9ical rese>*        
evaluation1 & biom$ical product         
assessm5t has improv$ or o!rwise has be5
 affect$ by ! am5dm5ts to section #bbh (
 ! ,public ,heal? ,s]vice ,act 7#db     
,u4,s4,c4 #bcg7 made by subsection 7a71 
includ+ by det]m9+1 dur+ ! p]iod betwe5 
! date ( enactm5t ( ?is ,act & !        
completion ( ! /udy--  7,a7 ! total     
numb] ( memb]s recruit$ & reta9$ "u !   
,s5ior ,biom$ical ,rese>* & ,biom$ical  
,product ,assessm5t ,s]vice "u su*      
section #bbh1 & ! effect ( increas+ !   

numb] ( memb]s eligible = su* ,s]vice2  
7,b7 ! numb] ( memb]s ( su* ,s5ior      
,biom$ical ,rese>* & ,biom$ical ,product
 ,assessm5t ,s]vice hir$ ) a doctoral   
level degree 9 biom$ic9e or a relat$    
field1 or doctoral or ma/]'s level      
degree 9 eng9e]+1 bio9=matics1 or a     
relat$ or em]g+ field2 &  7,c7 h[ _m    
,s5ior ,biom$ical ,rese>* & ,biom$ical  
,product ,assessm5t ,s]vice memb]s h be5
 hir$ by ea* ag5cy or dep>tm5t ( !      
,dep>tm5t ( ,heal? & ,human ,s]vices1 & 
h[ su* ,dep>tm5t assigns su* memb]s to  
ea* ag5cy or dep>tm5t4  #c4 ,hir+       
au?ority = sci5tific1 te*nical1 &       
pr(essional p]sonnel  7a7 ,9 g5]al ,!   
,f$]al ,food1 ,drug1 & ,cosmetic ,act is
 am5d$ by ins]t+ aft] section #gad 7#ba 
,u4,s4,c4 #cgi;d-#c7 ! foll[+3  #gad;,a4
 ,hir+ au?ority = sci5tific1 te*nical1 &
 pr(essional p]sonnel  7a7 ,9 g5]al ,!  
,secret>y may1 )\t reg>d to ! provisions
 ( title #e1 ,unit$ ,/ates ,code1 gov]n+
 appo9tm5ts 9 ! competitive s]vice1     
appo9t out/&+ & qualifi$ c&idates to    

sci5tific1 te*nical1 or pr(essional     
positions t support ! developm5t1       
review1 & regulation ( m$ical products4 
,su* positions %all be )9 ! competitive 
s]vice4  7b7 ,comp5sation  7#a7 ,9 g5]al
 ,not)/&+ any o!r provision ( law1      
includ+ any requirem5t ) respect to     
,g5]al ,s*$ule pay rates "u sub*apt]    
,,iii ( *apt] #ec ( title #e1 ,unit$    
,/ates ,code1 & consi/5t ) ! requirem5ts
 ( p>agraph 7#b71 ! ,commission] ( ,food
 & ,drugs may det]m9e & fix--  7,a7 !   
annual rate ( pay ( any individual      
appo9t$ "u subsection 7a72 &  7,b7 =    
purposes ( reta9+ qualifi$ employees1 ! 
annual rate ( pay = any qualifi$        
sci5tific1 te*nical1 or pr(essional     
p]sonnel appo9t$ to a position describ$ 
9 subsection 7a7 be=e ! date ( enactm5t 
( ?is section4  7#b7 ,limitation ,!     
annual rate ( pay e/abli%$ pursuant to  
p>agraph 7#a7 may n exce$ ! am\nt (     
annual comp5sation 7exclud+ exp5ses7    
specifi$ 9 section #ajb ( title #c1     
,unit$ ,/ates ,code4  7#c7 ,public      

availability ,! annual rate ( pay       
provid$ to an individual 9 accordance ) 
?is section %all be publicly available  
in=mation4  7c7 ,rule ( con/ruction ,!  
au?orities "u ?is section %all n be     
con/ru$ to affect ! au?ority provid$ "u 
section #gad4  7d7 ,report on work=ce   
plann+  7#a7 ,9 g5]al ,n lat] ?an #ah   
mon?s aft] ! date ( enactm5t ( ! ,,fda &
 ,,nih ,work=ce ,au?orities             
,mod]nization ,act1 ! ,secret>y %all    
submit a report on work=ce plann+ to !  
,committee on ,heal?1 ,education1       
,labor1 & ,p5sions ( ! ,s5ate & !       
,committee on ,en]gy & ,comm]ce ( !     
,h\se ( ,repres5tatives t exam9es !     
ext5t to :i* ! ,food & ,drug            
,adm9i/ration has a critical ne$ =      
qualifi$ individuals = sci5tific1       
te*nical1 or pr(essional positions1     
includ+--  7,a7 an analysis ( ! work=ce 
ne$s at ! ,food & ,drug ,adm9i/ration & 
! ,secret>y's /rategic plan = address+  
su* ne$s1 includ+ ?r\gh use ( ! au?ority
 "u ?is section2 &  7,b7 a recruitm5t & 

ret5tion plan = hir+ qualifi$ sci5tific1
 te*nical1 & pr(essional c&idates1 :i*  
may include ! use (--  7i7 recruitm5t   
?r\gh non-gov]nm5tal recruitm5t or      
placem5t ag5cies2  7ii7 recruitm5t ?r\gh
 academic in/itutions2  7iii7 recruitm5t
 or hir+ bonuses1 if applicable2  7iv7  
recruitm5t us+ t>get$ direct hir+       
au?orities2 &  7v7 ret5tion ( qualifi$  
sci5tific1 te*nical1 & pr(essional      
employees us+ ! au?ority "u ?is section1
 or o!r applicable au?orities ( !       
,secret>y4  7#b7 ,recomm5dations ,!     
report "u p>agraph 7#a7 may include !   
recomm5dations ( ! ,commission] ( ,food 
& ,drugs t w\ld help ! ,food & ,drug    
,adm9i/ration to bett] recruit & reta9  
qualifi$ individuals = sci5tific1       
te*nical1 or pr(essional positions at ! 
ag5cy4  4  7b7 ,,gao /udy & report  7#a7
 ,9 g5]al ,! ,comptroll] ,g5]al ( !     
,unit$ ,/ates %all conduct a /udy ( !   
ability ( ! ,food & ,drug ,adm9i/ration 
to hire1 tra91 & reta9 qualifi$         
sci5tific1 te*nical1 & pr(essional /aff1

 n includ+ contractors1 necess>y to     
fulfill ! mission ( ! ,food & ,drug     
,adm9i/ration to protect & promote      
public heal?4 ,n lat] ?an ,janu>y #a1   
#bjbb1 ! ,comptroll] ,g5]al %all submit 
a report on su* /udy to ! ,committee on 
,heal?1 ,education1 ,labor1 & ,p5sions (
 ! ,s5ate & ! ,committee on ,en]gy &    
,comm]ce ( ! ,h\se ( ,repres5tatives4   
7#b7 ,cont5ts ( /udy ,! ,comptroll]     
,g5]al %all include 9 ! /udy & report "u
 p>agraph 7#a7-- 7,a7 in=mation ab\t !  
progress ( ! ,food & ,drug ,adm9i/ration
 9 recruit+ & reta9+ qualifi$ sci5tific1
 te*nical1 & pr(essional /aff out/&+ 9 !
 field ( biom$ical rese>*1 cl9ical      
rese>* evaluation1 & biom$ical product  
assessm5t2  7,b7 ! ext5t to :i* critical
 /aff+ ne$s exi/ at ! ,food & ,drug     
,adm9i/ration1 & b>ri]s to hir+1 tra9+1 
& reta9+ qualifi$ /aff1 if any2  7,c7 an
 exam9ation ( ! recruitm5t & ret5tion   
/rategies ( ! ,food & ,drug             
,adm9i/ration1 includ+ exam9+ any       
/rategic work=ce plan1 focus$ on improv+

 sci5tific1 te*nical1 & pr(essional /aff
 recruitm5t & ret5tion2 &  7,d7         
recomm5dations = pot5tial improvem5ts t 
w\ld address /aff+ ne$s ( ! ,food &     
,drug ,adm9i/ration4  #d4 ,e/abli%m5t ( 
food & drug adm9i/ration int]c5t]       
in/itutes  7a7 ,9 g5]al ,*apt] ,x ( !   
,f$]al ,food1 ,drug1 & ,cosmetic ,act   
7#ba ,u4,s4,c4 #cia et seq47 is am5d$ by
 add+ at ! end ! foll[+3  #ajad4 ,food &
 ,drug ,adm9i/ration ,int]c5t]          
,in/itutes  7a7 ,9 g5]al ,! ,secret>y   
%all e/abli% "o or m ,int]c5t]          
,in/itutes )9 ! ,food & ,drug           
,adm9i/ration 7ref]r$ to 9 ?is section z
 an ,in/itute7 = a major disease area or
 areas4 ,) respect to ! major disease   
area ( focus ( an ,in/itute1 su*        
,in/itute %all develop & implem5t       
processes = coord9ation ( activities1 z 
applicable to su* major disease area or 
areas1 betwe5 ! ,c5t] = ,drug           
,evaluation & ,rese>*1 ! ,c5t] =        
,biologics ,evaluation & ,rese>*1 & !   
,c5t] = ,devices & ,radiological ,heal? 

7= ! purposes ( ?is section1 ref]r$ to z
 ! ,c5t]s74 ,su* activities may         
include--  7#a7 coord9ation ( /aff f !  
,c5t]s ) div]se product exp]tise 9 !    
diagnosis1 cure1 mitigation1 treatm5t1  
or prev5tion ( ! specific diseases      
relevant to ! major disease area ( focus
 ( ! ,in/itute2  7#b7 /reaml9+1 :]e     
appropriate1 ! review ( m$ical products 
to diagnose1 cure1 mitigate1 treat1 or  
prev5t ! major disease area ( focus ( ! 
,in/itute1 apply+ relevant /&>ds "u     
sections #eje1 #eaj7k71 & #eae ( ?is    
,act & section #cea ( ! ,public ,heal?  
,s]vice ,act1 & o!r applicable          
au?orities2  7#c7 promotion ( sci5tific 
programs )9 ! ,c5t]s relat$ to ! major  
disease area ( focus ( ! ,in/itute2     
7#d7 developm5t ( programs & enhancem5t 
( /rategies to recruit1 tra91 & provide 
cont9u+ education opportunities = !     
p]sonnel ( ! ,c5t]s ) exp]tise relat$ to
 ! major disease area ( focus ( !       
,in/itute2  7#e7 enhancem5t ( !         
int]actions ( ! ,c5t]s ) pati5ts1       

sponsors1 & ! ext]nal biom$ical         
community reg>d+ ! major disease area ( 
focus ( ! ,in/itute2 &  7#f7            
facilitation ( ! collaborative          
relation%ips ( ! ,c5t]s ) o!r ag5cies )9
 ! ,dep>tm5t ( ,heal? & ,human ,s]vices 
reg>d+ ! major disease area ( focus ( ! 
,in/itute4  7b7 ,implem5tation plan     
,prior to e/abli%+ an ,in/itute "u      
subsection 7a71 & n lat] ?an #a ye> aft]
 ! date ( enactm5t ( ! ,,fda & ,,nih    
,work=ce ,au?orities ,mod]nization ,act1
 ! ,secret>y %all publi% a draft        
implem5tation plan = su* ,in/itute1 &   
provide = n less ?an #fj cal5d> days =  
public comm5t on su* plan4  7c7 ,tim+ ,!
 ,secret>y %all e/abli% at lea/ "o      
,in/itute "u subsection 7a7 )9 #a ye> ( 
! clos+ ( ! public comm5t p]iod "u      
subsection 7b71 unless ! ,secret>y      
det]m9es t e/abli%+ su* ,in/itute w\ld n
 be feasible or w\ld n b5efit ! public  
heal?1 & publi%es su* det]m9ation on !  
public ,int]net website ( ! ,food &     
,drug ,adm9i/ration4  7d7 ,t]m9ation (  

in/itutes ,! ,secret>y may t]m9ate any  
,in/itute e/abli%$ pursuant to ?is      
section if ! ,secret>y det]m9es su*     
,in/itute is no long] b5efitt+ ! public 
heal?4 ,n less ?an #fj days prior to s  
t]m9at+ an ,in/itute1 ! ,secret>y %all  
provide public notice1 includ+ !        
rationale = su* t]m9ation4  4  7b7      
,te*nical am5dm5ts ,*apt] ,x ( ! ,f$]al 
,food1 ,drug1 & ,cosmetic ,act 7#ba     
,u4,s4,c4 #cia et seq47 is am5d$-- 7#a7 
by r$esignat+ section #ajab z section   
#ajac2 &  7#b7 by r$esignat+ ! second   
section #ajaa 7) respect to improv+ !   
tra9+ ( ,/ate1 local1 t]ritorial1 &     
tribal food safety (ficials71 z add$ by 
section #bji7;a7 ( ! ,,fda ,food ,safety
 ,mod]nization ,act 7,public ,law       
#aaa-cec71 z section #ajab4  #e4        
,sci5tific meet+s  7a7 ,9 g5]al         
,sci5tific meet+s t are att5d$ by       
sci5tific or m$ical p]sonnel1 or o!r    
pr(essionals1 ( ! ,dep>tm5t ( ,heal? &  
,human ,s]vices = :om att5dance at su*  
meet+ is directly relat$ to _!          

pr(essional duties & ! mission ( !      
,dep>tm5t--  7#a7 %all n be consid]$    
conf]5ces = ! purposes ( comply+ )      
,f$]al report+ requirem5ts conta9$ 9    
annual appropriations ,acts or 9 ?is    
section2 &  7#b7 %all n be consid]$     
conf]5ces = purposes ( a re/riction     
conta9$ 9 an annual appropriations ,act1
 bas$ on ,(fice ( ,managem5t & ,budget  
,memor&um ,m-#ab-ab or any o!r          
regulation re/rict+ su* travel4  7b7    
,limitation ,no?+ 9 ?is section %all be 
con/ru$ to exempt travel = sci5tific    
meet+s f ,f$]al regulations relat+ to   
travel4  7c7 ,reports ,ea* op]at+       
division ( ! ,dep>tm5t ( ,heal? & ,human
 ,s]vices %all prep>e1 & po/ on an      
,int]net website ( ! op]at+ division1 an
 annual report on sci5tific meet+       
att5dance & relat$ travel sp5d+ = ea*   
fiscal ye>4 ,su* report %all include--  
7#a7 g5]al in=mation conc]n+ ! sci5tific
 meet+ activities involv$2  7#b7        
in=mation conc]n+ ! total am\nt exp5d$ =
 su* meet+s2  7#c7 a description ( all  

su* meet+s t 7 att5d$ by sci5tific or   
m$ical p]sonnel1 or o!r pr(essionals1 ( 
ea* su* op]at+ division :]e ! total     
am\nt exp5d$ by ! op]at+ division       
associat$ ) ea* su* meet+ are 9 excess (
 #cj1jjj1 includ+--  7,a7 ! total am\nt 
( meet+ exp5ses incurr$ by ! op]at+     
division = su* meet+2  7,b7 ! location (
 su* meet+2  7,c7 ! date ( su* meet+2   
7,d7 a brief explanation on h[ su* meet+
 advanc$ ! mission ( ! op]at+ division2 
&  7,e7 ! total numb] ( individuals ^:  
travel exp5ses or o!r sci5tific meet+   
exp5ses 7 paid by ! op]at+ division2 &  
7#d7 ) respect to any su* meet+ :]e !   
total exp5ses to ! op]at+ division      
exce$$ #aej1jjj1 a description ( !      
exceptional circum/ances t necessitat$ !
 exp5diture ( su* am\nts4  #f4          
,reagan-,udall ,f\ndation = ! ,food &   
,drug ,adm9i/ration  7a7 ,bo>d (        
,directors  7#a7 ,composition & size    
,section #ggj7;d77#a77;,c7 ( ! ,f$]al   
,food1 ,drug1 & ,cosmetic ,act 7#ba     
,u4,s4,c4 #cgi;dd7d77#a77;,c77 is       

am5d$--  7,a7 by r$esignat+ clause 7ii7 
z clause 7iii72  7,b7 by ins]t+ aft]    
clause 7i7 ! foll[+3  7ii7 ,additional  
memb]s ,! ,bo>d1 ?r\gh am5dm5ts to !    
bylaws ( ! ,f\ndation1 may provide t !  
numb] ( vot+ memb]s ( ! ,bo>d %all be a 
numb] 7to be specifi$ 9 su* am5dm5t7    
great] ?an #ad4 ,any ,bo>d positions t  
are e/abli%$ by any su* am5dm5t %all be 
appo9t$ 7by majority vote7 by !         
individuals :o1 z ( ! date ( su*        
am5dm5t1 are vot+ memb]s ( ! ,bo>d &    
p]sons s appo9t$ may repres5t any ( !   
categories specifi$ 9 subclauses 7,i7   
?r\gh 7,v7 ( clause 7i71 s long z no m  
?an #cj p]c5t ( ! total vot+ memb]s ( ! 
,bo>d 7includ+ memb]s ^: positions are  
e/abli%$ by su* am5dm5t7 are            
repres5tatives ( ! g5]al ph>maceutical1 
device1 food1 cosmetic1 & biote*nology  
indu/ries4  2 &  7,c7 9 clause          
7iii77,i71 z r$esignat$ by subp>agraph  
7,a71 by /rik+ ,! ex (ficio memb]s %all 
ensure & ins]t+ ,! ex (ficio memb]s1    
act+ pursuant to clause 7i71 & ! ,bo>d1 

act+ pursuant to clause 7ii71 %all      
ensure4  7#b7 ,f$]al employees all[$ to 
s]ve on ,bo>d ,clause 7iii77,,ii7 (     
section #ggj7;d77#a77;,c7 ( ! ,f$]al    
,food1 ,drug1 & ,cosmetic ,act 7#ba     
,u4,s4,c4 #cgi;dd7d77#a77;,c771 z       
r$esignat$ by p>agraph 7#a77;,a71 is    
am5d$ by add+ at ! end ! foll[+3 ,=     
purposes ( ?is section1 ! t]m employee (
 ! ,f$]al ,gov]nm5t does n include a    
special ,gov]nm5t employee1 z t t]m is  
def9$ 9 section #bjb7;a7 ( title #ah1   
,unit$ ,/ates ,code44  7#c7 ,/agg]$ t]ms
 ,subp>agraph 7,a7 ( section            
#ggj7;d77#c7 ( ! ,f$]al ,food1 ,drug1 & 
,cosmetic ,act 7#ba ,u4,s4,c4           
#cgi;dd7d77#c77 is am5d$ to read z      
foll[s3  7,a7 ,t]m ,! t]m ( (fice ( ea* 
memb] ( ! ,bo>d appo9t$ "u p>agraph     
7#a77;,c77i71 & ! t]m ( (fice ( any     
memb] ( ! ,bo>d ^: position is e/abli%$ 
pursuant to p>agraph 7#a77;,c77ii71 %all
 be #d ye>s1 except t--  7i7 ! t]ms (   
(fices = ! memb]s ( ! ,bo>d initially   
appo9t$ "u p>agraph 7#a77;,c77i7 %all   

expire on a /agg]$ basis z det]m9$ by ! 
ex (ficio memb]s2 &  7ii7 ! t]ms ( (fice
 = ! p]sons initially appo9t$ to        
positions e/abli%$ pursuant to p>agraph 
7#a77;,c77ii7 may be made to expire on a
 /agg]$ basis1 z det]m9$ by !           
individuals :o1 z ( ! date ( ! am5dm5t  
e/abli%+ su* positions1 are memb]s ( !  
,bo>d4  4  7b7 ,executive ,director     
comp5sation ,section #ggj7;g77#b7 ( !   
,f$]al ,food1 ,drug1 & ,cosmetic ,act   
7#ba ,u4,s4,c4 #cgi;dd7g77#b77 is am5d$ 
by /rik+ b %all n be great] ?an !       
comp5sation ( ! ,commission]4  7c7      
,sep>ation ( ,funds ,section #ggj7m7 ( !
 ,f$]al ,food1 ,drug1 & ,cosmetic ,act  
7#ba ,u4,s4,c4 #cgi;dd7m77 is am5d$ by  
/rik+ are held 9 sep>ate acc\nts f funds
 receiv$ f entities "u subsection 7i7 & 
ins]t+ are manag$ z individual          
programmatic funds "u subsection 7i71   
accord+ to be/ acc\nt+ practices4  #g4  
,,nih rese>* in=mation collection       
exempt$ f ,pap]work ,r$uction ,act      
,section #cja ( ! ,public ,heal? ,s]vice

 ,act 7#db ,u4,s4,c4 #bda7 is am5d$ by  
add+ to ! end ! foll[+3  7f7 ,pap]work  
r$uction ,sub*apt] ,i ( *apt] #ce (     
title #dd1 ,unit$ ,/ates ,code1 %all n  
apply to ! collection ( in=mation dur+ !
 conduct ( rese>* by ! ,national        
,in/itutes ( ,heal?4  4  #h4 ,/udies ,! 
,f$]al ,food1 ,drug1 & ,cosmetic ,act is
 am5d$-- 7#a7 9 section #eje7k77#e7 7#ba
 ,u4,s4,c4 #cee7k77#e77--  7,a7 9       
subp>agraph 7,a71 by ins]t+ & aft] !    
semicolon2  7,b7 by /rik+ subp>agraph   
7,b72 &  7,c7 by r$esignat+ subp>agraph 
7,c7 z subp>agraph 7,b72  7#b7 9 section
 #eje;,a 7#ba ,u4,s4,c4 #cee;a71 by     
/rik+ subsection 7p72  7#c7 9 section   
#eje;,b 7#ba ,u4,s4,c4 #cee;c7-- 7,a7 by
 /rik+ subsection 7l72 &  7,b7 by       
r$esignat+ subsection 7m7 z subsection  
7l72 &  7#d7 9 section #ebc 7#ba        
,u4,s4,c4 #cfjm71 by /rik+ subsection   
7d74  #a4 ,%ort title ,?is ,act may be  
cit$ z ! ,,fda & ,,nih ,work=ce         
,au?orities ,mod]nization ,act4  #b4    
,silvio ,o4 ,conte s5ior biom$ical      

rese>* s]vice  7a7 ,hir+ & ret5tion     
au?ority ,section #bbh ( ! ,public      
,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bcg7
 is am5d$-- 7#a7 9 ! section head+1 by  
ins]t+ & ,biom$ical ,product ,assessm5t 
aft] ,rese>*2  7#b7 9 subsection 7a7--  
7,a7 9 p>agraph 7#a71 by /rik+ ,silvio  
,o4 ,conte ,s5ior ,biom$ical ,rese>*    
,s]vice1 n to exce$ #ejj memb]s & ins]t+
 ,silvio ,o4 ,conte ,s5ior ,biom$ical   
,rese>* & ,biom$ical ,product ,assessm5t
 ,s]vice 79 ?is section ref]r$ to z !   
,s]vice71 n to exce$ #b1jjj memb]s1 !   
purpose ( :i* is to recruit & reta9     
out/&+ & qualifi$ sci5tific & te*nical  
exp]ts 9 ! fields ( biom$ical rese>*1   
cl9ical rese>* evaluation1 & biom$ical  
product assessm5t2  7,b7 by am5d+       
p>agraph 7#b7 to read z foll[s3  7#b7 ,!
 au?ority e/abli%$ 9 p>agraph 7#a7 may n
 be con/ru$ to require ! ,secret>y to   
r$uce ! numb] ( employees s]v+ "u any   
o!r employm5t sy/em 9 ord] to (fset !   
numb] ( memb]s s]v+ 9 ! ,s]vice4  2 &   
7,c7 by add+ at ! end ! foll[+3  7#c7 ,!

 ,secret>y %all assign exp]ts "u ?is    
section to ag5cies )9 ! ,dep>tm5t (     
,heal? & ,human ,s]vices tak+ into      
acc\nt ! ne$ = ! exp]tise ( su* exp]t4  
2  7#c7 9 subsection 7b7-- 7,a7 9 !     
matt] prec$+ p>agraph 7#a71 by /rik+ or 
cl9ical rese>* evaluation & ins]t+ 1    
cl9ical rese>* evaluation1 or biom$ical 
product assessm5t2 &  7,b7 9 p>agraph   
7#a71 by ins]t+ or a doctoral or ma/]'s 
level degree 9 eng9e]+1 bio9=matics1 or 
a relat$ or em]g+ field1 aft] ! comma2  
7#d7 9 subsection 7d77#b71 by /rik+ &   
%all n exce$ ! rate payable = level ,i (
 ! ,executive ,s*$ule unless approv$ by 
! ,presid5t "u section #ecgg7;d77#b7 (  
title #e1 ,unit$ ,/ates ,code & ins]t+ &
 %all n exce$ ! am\nt ( annual          
comp5sation 7exclud+ exp5ses7 specifi$ 9
 section #ajb ( title #c1 ,unit$ ,/ates 
,code2  7#e7 by /rik+ subsection 7e72 & 
7#f7 by r$esignat+ subsections 7f7 & 7g7
 z subsections 7e7 & 7f71 respectively4 
7b7 ,,gao /udy  7#a7 ,9 g5]al ,!        
,comptroll] ,g5]al ( ! ,unit$ ,/ates    

%all conduct a /udy ( ! effectiv5ess ( !
 am5dm5ts to section #bbh ( ! ,public   
,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bcg7
 made by subsection 7a7 & ! impact ( su*
 am5dm5ts1 if any1 on all ag5cies or    
dep>tm5ts ( ! ,dep>tm5t ( ,heal? &      
,human ,s]vices1 &1 n lat] ?an #d ye>s  
aft] ! date ( enactm5t ( ?is ,act1 %all 
submit a report bas$ on su* /udy to !   
,committee on ,heal?1 ,education1       
,labor1 & ,p5sions ( ! ,s5ate & !       
,committee on ,en]gy & ,comm]ce ( !     
,h\se ( ,repres5tatives4  7#b7 ,cont5t (
 /udy & report ,! /udy & report "u      
p>agraph 7#a7 %all include an exam9ation
 ( ! ext5t to :i* recruitm5t & ret5tion 
( out/&+ & qualifi$ sci5tific1 m$ical1  
or te*nical exp]ts 9 ! fields (         
biom$ical rese>*1 cl9ical rese>*        
evaluation1 & biom$ical product         
assessm5t has improv$ or o!rwise has be5
 affect$ by ! am5dm5ts to section #bbh (
 ! ,public ,heal? ,s]vice ,act 7#db     
,u4,s4,c4 #bcg7 made by subsection 7a71 
includ+ by det]m9+1 dur+ ! p]iod betwe5 

! date ( enactm5t ( ?is ,act & !        
completion ( ! /udy--  7,a7 ! total     
numb] ( memb]s recruit$ & reta9$ "u !   
,s5ior ,biom$ical ,rese>* & ,biom$ical  
,product ,assessm5t ,s]vice "u su*      
section #bbh1 & ! effect ( increas+ !   
numb] ( memb]s eligible = su* ,s]vice2  
7,b7 ! numb] ( memb]s ( su* ,s5ior      
,biom$ical ,rese>* & ,biom$ical ,product
 ,assessm5t ,s]vice hir$ ) a doctoral   
level degree 9 biom$ic9e or a relat$    
field1 or doctoral or ma/]'s level      
degree 9 eng9e]+1 bio9=matics1 or a     
relat$ or em]g+ field2 &  7,c7 h[ _m    
,s5ior ,biom$ical ,rese>* & ,biom$ical  
,product ,assessm5t ,s]vice memb]s h be5
 hir$ by ea* ag5cy or dep>tm5t ( !      
,dep>tm5t ( ,heal? & ,human ,s]vices1 & 
h[ su* ,dep>tm5t assigns su* memb]s to  
ea* ag5cy or dep>tm5t4  #c4 ,hir+       
au?ority = sci5tific1 te*nical1 &       
pr(essional p]sonnel  7a7 ,9 g5]al ,!   
,f$]al ,food1 ,drug1 & ,cosmetic ,act is
 am5d$ by ins]t+ aft] section #gad 7#ba 
,u4,s4,c4 #cgi;d-#c7 ! foll[+3  #gad;,a4

 ,hir+ au?ority = sci5tific1 te*nical1 &
 pr(essional p]sonnel  7a7 ,9 g5]al ,!  
,secret>y may1 )\t reg>d to ! provisions
 ( title #e1 ,unit$ ,/ates ,code1 gov]n+
 appo9tm5ts 9 ! competitive s]vice1     
appo9t out/&+ & qualifi$ c&idates to    
sci5tific1 te*nical1 or pr(essional     
positions t support ! developm5t1       
review1 & regulation ( m$ical products4 
,su* positions %all be )9 ! competitive 
s]vice4  7b7 ,comp5sation  7#a7 ,9 g5]al
 ,not)/&+ any o!r provision ( law1      
includ+ any requirem5t ) respect to     
,g5]al ,s*$ule pay rates "u sub*apt]    
,,iii ( *apt] #ec ( title #e1 ,unit$    
,/ates ,code1 & consi/5t ) ! requirem5ts
 ( p>agraph 7#b71 ! ,commission] ( ,food
 & ,drugs may det]m9e & fix--  7,a7 !   
annual rate ( pay ( any individual      
appo9t$ "u subsection 7a72 &  7,b7 =    
purposes ( reta9+ qualifi$ employees1 ! 
annual rate ( pay = any qualifi$        
sci5tific1 te*nical1 or pr(essional     
p]sonnel appo9t$ to a position describ$ 
9 subsection 7a7 be=e ! date ( enactm5t 

( ?is section4  7#b7 ,limitation ,!     
annual rate ( pay e/abli%$ pursuant to  
p>agraph 7#a7 may n exce$ ! am\nt (     
annual comp5sation 7exclud+ exp5ses7    
specifi$ 9 section #ajb ( title #c1     
,unit$ ,/ates ,code4  7#c7 ,public      
availability ,! annual rate ( pay       
provid$ to an individual 9 accordance ) 
?is section %all be publicly available  
in=mation4  7c7 ,rule ( con/ruction ,!  
au?orities "u ?is section %all n be     
con/ru$ to affect ! au?ority provid$ "u 
section #gad4  7d7 ,report on work=ce   
plann+  7#a7 ,9 g5]al ,n lat] ?an #ah   
mon?s aft] ! date ( enactm5t ( ! ,,fda &
 ,,nih ,work=ce ,au?orities             
,mod]nization ,act 1 ! ,secret>y %all   
submit a report on work=ce plann+ to !  
,committee on ,heal?1 ,education1       
,labor1 & ,p5sions ( ! ,s5ate & !       
,committee on ,en]gy & ,comm]ce ( !     
,h\se ( ,repres5tatives t exam9es !     
ext5t to :i* ! ,food & ,drug            
,adm9i/ration has a critical ne$ =      
qualifi$ individuals = sci5tific1       

te*nical1 or pr(essional positions1     
includ+--  7,a7 an analysis ( ! work=ce 
ne$s at ! ,food & ,drug ,adm9i/ration & 
! ,secret>y's /rategic plan = address+  
su* ne$s1 includ+ ?r\gh use ( ! au?ority
 "u ?is section2 &  7,b7 a recruitm5t & 
ret5tion plan = hir+ qualifi$ sci5tific1
 te*nical1 & pr(essional c&idates1 :i*  
may include ! use (--  7i7 recruitm5t   
?r\gh non-gov]nm5tal recruitm5t or      
placem5t ag5cies2  7ii7 recruitm5t ?r\gh
 academic in/itutions2  7iii7 recruitm5t
 or hir+ bonuses1 if applicable2  7iv7  
recruitm5t us+ t>get$ direct hir+       
au?orities2 &  7v7 ret5tion ( qualifi$  
sci5tific1 te*nical1 & pr(essional      
employees us+ ! au?ority "u ?is section1
 or o!r applicable au?orities ( !       
,secret>y4  7#b7 ,recomm5dations ,!     
report "u p>agraph 7#a7 may include !   
recomm5dations ( ! ,commission] ( ,food 
& ,drugs t w\ld help ! ,food & ,drug    
,adm9i/ration to bett] recruit & reta9  
qualifi$ individuals = sci5tific1       
te*nical1 or pr(essional positions at ! 

ag5cy4  4  7b7 ,,gao /udy & report  7#a7
 ,9 g5]al ,! ,comptroll] ,g5]al ( !     
,unit$ ,/ates %all conduct a /udy ( !   
ability ( ! ,food & ,drug ,adm9i/ration 
to hire1 tra91 & reta9 qualifi$         
sci5tific1 te*nical1 & pr(essional /aff1
 n includ+ contractors1 necess>y to     
fulfill ! mission ( ! ,food & ,drug     
,adm9i/ration to protect & promote      
public heal?4 ,n lat] ?an ,janu>y #a1   
#bjbb1 ! ,comptroll] ,g5]al %all submit 
a report on su* /udy to ! ,committee on 
,heal?1 ,education1 ,labor1 & ,p5sions (
 ! ,s5ate & ! ,committee on ,en]gy &    
,comm]ce ( ! ,h\se ( ,repres5tatives4   
7#b7 ,cont5ts ( /udy ,! ,comptroll]     
,g5]al %all include 9 ! /udy & report "u
 p>agraph 7#a7-- 7,a7 in=mation ab\t !  
progress ( ! ,food & ,drug ,adm9i/ration
 9 recruit+ & reta9+ qualifi$ sci5tific1
 te*nical1 & pr(essional /aff out/&+ 9 !
 field ( biom$ical rese>*1 cl9ical      
rese>* evaluation1 & biom$ical product  
assessm5t2  7,b7 ! ext5t to :i* critical
 /aff+ ne$s exi/ at ! ,food & ,drug     

,adm9i/ration1 & b>ri]s to hir+1 tra9+1 
& reta9+ qualifi$ /aff1 if any2  7,c7 an
 exam9ation ( ! recruitm5t & ret5tion   
/rategies ( ! ,food & ,drug             
,adm9i/ration1 includ+ exam9+ any       
/rategic work=ce plan1 focus$ on improv+
 sci5tific1 te*nical1 & pr(essional /aff
 recruitm5t & ret5tion2 &  7,d7         
recomm5dations = pot5tial improvem5ts t 
w\ld address /aff+ ne$s ( ! ,food &     
,drug ,adm9i/ration4  #d4 ,e/abli%m5t ( 
,food & ,drug ,adm9i/ration ,int]c5t]   
,in/itutes  7a7 ,9 g5]al ,*apt] ,x ( !  
,f$]al ,food1 ,drug1 & ,cosmetic ,act   
7#ba ,u4,s4,c4 #cia et seq47 is am5d$ by
 add+ at ! end ! foll[+3  #ajad4 ,food &
 ,drug ,adm9i/ration ,int]c5t]          
,in/itutes  7a7 ,9 g5]al ,! ,secret>y   
%all e/abli% "o or m ,int]c5t]          
,in/itutes )9 ! ,food & ,drug           
,adm9i/ration 7ref]r$ to 9 ?is section z
 an ,in/itute7 = a major disease area or
 areas4 ,) respect to ! major disease   
area ( focus ( an ,in/itute1 su*        
,in/itute %all develop & implem5t       

processes = coord9ation ( activities1 z 
applicable to su* major disease area or 
areas1 betwe5 ! ,c5t] = ,drug           
,evaluation & ,rese>*1 ! ,c5t] =        
,biologics ,evaluation & ,rese>*1 & !   
,c5t] = ,devices & ,radiological ,heal? 
7= ! purposes ( ?is section1 ref]r$ to z
 ! ,c5t]s74 ,su* activities may         
include--  7#a7 coord9ation ( /aff f !  
,c5t]s ) div]se product exp]tise 9 !    
diagnosis1 cure1 mitigation1 treatm5t1  
or prev5tion ( ! specific diseases      
relevant to ! major disease area ( focus
 ( ! ,in/itute2  7#b7 /reaml9+1 :]e     
appropriate1 ! review ( m$ical products 
to diagnose1 cure1 mitigate1 treat1 or  
prev5t ! major disease area ( focus ( ! 
,in/itute1 apply+ relevant /&>ds "u     
sections #eje1 #eaj7k71 #eac7;f77#b71 & 
#eae ( ?is ,act & section #cea ( !      
,public ,heal? ,s]vice ,act1 & o!r      
applicable au?orities2  7#c7 promotion (
 sci5tific programs )9 ! ,c5t]s relat$  
to ! major disease area ( focus ( !     
,in/itute2  7#d7 developm5t ( programs &

 enhancem5t ( /rategies to recruit1     
tra91 & provide cont9u+ education       
opportunities = ! p]sonnel ( ! ,c5t]s ) 
exp]tise relat$ to ! major disease area 
( focus ( ! ,in/itute2  7#e7 enhancem5t 
( ! int]actions ( ! ,c5t]s ) pati5ts1   
sponsors1 & ! ext]nal biom$ical         
community reg>d+ ! major disease area ( 
focus ( ! ,in/itute2 &  7#f7            
facilitation ( ! collaborative          
relation%ips ( ! ,c5t]s ) o!r ag5cies )9
 ! ,dep>tm5t ( ,heal? & ,human ,s]vices 
reg>d+ ! major disease area ( focus ( ! 
,in/itute4  7b7 ,public process ,!      
,secret>y %all provide a p]iod = public 
comm5t dur+ ! "t t ea* ,in/itute is be+ 
implem5t$4  7c7 ,tim+ ,! ,secret>y %all 
e/abli% at lea/ "o ,in/itute "u         
subsection 7a7 be=e ! date t is #a ye>  
aft] ! date ( enactm5t ( ! ,,fda & ,,nih
 ,work=ce ,au?orities ,mod]nization     
,act4  7d7 ,t]m9ation ( in/itutes ,!    
,secret>y may t]m9ate any ,in/itute     
e/abli%$ pursuant to ?is section if !   
,secret>y det]m9es su* ,in/itute is no  

long] b5efitt+ ! public heal?4 ,n less  
?an #fj days prior to s t]m9at+ an      
,in/itute1 ! ,secret>y %all provide     
public notice1 includ+ ! rationale = su*
 t]m9ation4  4  7b7 ,te*nical am5dm5ts  
,*apt] ,x ( ! ,f$]al ,food1 ,drug1 &    
,cosmetic ,act 7#ba ,u4,s4,c4 #cia et   
seq47 is am5d$-- 7#a7 by r$esignat+     
section #ajab z section #ajac2 &  7#b7  
by r$esignat+ ! second section #ajaa 7) 
respect to improv+ ! tra9+ ( ,/ate1     
local1 t]ritorial1 & tribal food safety 
(ficials71 z add$ by section #bji7;a7 ( 
! ,,fda ,food ,safety ,mod]nization ,act
 7,public ,law #aaa-cec71 z section     
#ajab4  #e4 ,sci5tific meet+s  7a7 ,9   
g5]al ,sci5tific meet+s t are att5d$ by 
sci5tific or m$ical p]sonnel1 or o!r    
pr(essionals1 ( ! ,dep>tm5t ( ,heal? &  
,human ,s]vices = :om att5dance at su*  
meet+ is directly relat$ to _!          
pr(essional duties & ! mission ( !      
,dep>tm5t--  7#a7 %all n be consid]$    
conf]5ces = ! purposes ( comply+ )      
,f$]al report+ requirem5ts conta9$ 9    

annual appropriations ,acts or 9 ?is    
section2 &  7#b7 %all n be consid]$     
conf]5ces = purposes ( a re/riction     
conta9$ 9 an annual appropriations ,act1
 bas$ on ,(fice ( ,managem5t & ,budget  
,memor&um ,m-#ab-ab or any o!r          
regulation re/rict+ su* travel4  7b7    
,limitation ,no?+ 9 ?is section %all be 
con/ru$ to exempt travel = sci5tific    
meet+s f ,f$]al regulations relat+ to   
travel4  7c7 ,reports ,ea* op]at+       
division ( ! ,dep>tm5t ( ,heal? & ,human
 ,s]vices %all prep>e1 & po/ on an      
,int]net website ( ! op]at+ division1 an
 annual report on sci5tific meet+       
att5dance & relat$ travel sp5d+ = ea*   
fiscal ye>4 ,su* report %all include--  
7#a7 g5]al in=mation conc]n+ ! sci5tific
 meet+ activities involv$2  7#b7        
in=mation conc]n+ ! total am\nt exp5d$ =
 su* meet+s2  7#c7 a description ( all  
su* meet+s t 7 att5d$ by sci5tific or   
m$ical p]sonnel1 or o!r pr(essionals1 ( 
ea* su* op]at+ division :]e ! total     
am\nt exp5d$ by ! op]at+ division       

associat$ ) ea* su* meet+ are 9 excess (
 #cj1jjj1 includ+--  7,a7 ! total am\nt 
( meet+ exp5ses incurr$ by ! op]at+     
division = su* meet+2  7,b7 ! location (
 su* meet+2  7,c7 ! date ( su* meet+2   
7,d7 a brief explanation on h[ su* meet+
 advanc$ ! mission ( ! op]at+ division2 
&  7,e7 ! total numb] ( individuals ^:  
travel exp5ses or o!r sci5tific meet+   
exp5ses 7 paid by ! op]at+ division2 &  
7#d7 ) respect to any su* meet+ :]e !   
total exp5ses to ! op]at+ division      
exce$$ #aej1jjj1 a description ( !      
exceptional circum/ances t necessitat$ !
 exp5diture ( su* am\nts4  #f4          
,reagan-,udall ,f\ndation = ! ,food &   
,drug ,adm9i/ration  7a7 ,bo>d (        
,directors  7#a7 ,composition & size    
,section #ggj7;d77#a77;,c7 ( ! ,f$]al   
,food1 ,drug1 & ,cosmetic ,act 7#ba     
,u4,s4,c4 #cgi;dd7d77#a77;,c77 is       
am5d$--  7,a7 by r$esignat+ clause 7ii7 
z clause 7iii72  7,b7 by ins]t+ aft]    
clause 7i7 ! foll[+3  7ii7 ,additional  
memb]s ,! ,bo>d1 ?r\gh am5dm5ts to !    

bylaws ( ! ,f\ndation1 may provide t !  
numb] ( vot+ memb]s ( ! ,bo>d %all be a 
numb] 7to be specifi$ 9 su* am5dm5t7    
great] ?an #ad4 ,any ,bo>d positions t  
are e/abli%$ by any su* am5dm5t %all be 
appo9t$ 7by majority vote7 by !         
individuals :o1 z ( ! date ( su*        
am5dm5t1 are vot+ memb]s ( ! ,bo>d &    
p]sons s appo9t$ may repres5t any ( !   
categories specifi$ 9 subclauses 7,i7   
?r\gh 7,v7 ( clause 7i71 s long z no m  
?an #cj p]c5t ( ! total vot+ memb]s ( ! 
,bo>d 7includ+ memb]s ^: positions are  
e/abli%$ by su* am5dm5t7 are            
repres5tatives ( ! g5]al ph>maceutical1 
device1 food1 cosmetic1 & biote*nology  
indu/ries4  2 &  7,c7 9 clause          
7iii77,i71 z r$esignat$ by subp>agraph  
7,a71 by /rik+ ,! ex (ficio memb]s %all 
ensure & ins]t+ ,! ex (ficio memb]s1    
act+ pursuant to clause 7i71 & ! ,bo>d1 
act+ pursuant to clause 7ii71 %all      
ensure4  7#b7 ,f$]al employees all[$ to 
s]ve on ,bo>d ,clause 7iii77,,ii7 (     
section #ggj7;d77#a77;,c7 ( ! ,f$]al    

,food1 ,drug1 & ,cosmetic ,act 7#ba     
,u4,s4,c4 #cgi;dd7d77#a77;,c771 z       
r$esignat$ by p>agraph 7#a77;,a71 is    
am5d$ by add+ at ! end ! foll[+3 ,=     
purposes ( ?is section1 ! t]m employee (
 ! ,f$]al ,gov]nm5t does n include a    
special ,gov]nm5t employee1 z t t]m is  
def9$ 9 section #bjb7;a7 ( title #ah1   
,unit$ ,/ates ,code44  7#c7 ,/agg]$ t]ms
 ,subp>agraph 7,a7 ( section            
#ggj7;d77#c7 ( ! ,f$]al ,food1 ,drug1 & 
,cosmetic ,act 7#ba ,u4,s4,c4           
#cgi;dd7d77#c77 is am5d$ to read z      
foll[s3  7,a7 ,t]m ,! t]m ( (fice ( ea* 
memb] ( ! ,bo>d appo9t$ "u p>agraph     
7#a77;,c77i71 & ! t]m ( (fice ( any     
memb] ( ! ,bo>d ^: position is e/abli%$ 
pursuant to p>agraph 7#a77;,c77ii71 %all
 be #d ye>s1 except t--  7i7 ! t]ms (   
(fices = ! memb]s ( ! ,bo>d initially   
appo9t$ "u p>agraph 7#a77;,c77i7 %all   
expire on a /agg]$ basis z det]m9$ by ! 
ex (ficio memb]s2 &  7ii7 ! t]ms ( (fice
 = ! p]sons initially appo9t$ to        
positions e/abli%$ pursuant to p>agraph 

7#a77;,c77ii7 may be made to expire on a
 /agg]$ basis1 z det]m9$ by !           
individuals :o1 z ( ! date ( ! am5dm5t  
e/abli%+ su* positions1 are memb]s ( !  
,bo>d4  4  7b7 ,executive ,director     
comp5sation ,section #ggj7;g77#b7 ( !   
,f$]al ,food1 ,drug1 & ,cosmetic ,act   
7#ba ,u4,s4,c4 #cgi;dd7g77#b77 is am5d$ 
by /rik+ b %all n be great] ?an !       
comp5sation ( ! ,commission]4  7c7      
,sep>ation ( ,funds ,section #ggj7m7 ( !
 ,f$]al ,food1 ,drug1 & ,cosmetic ,act  
7#ba ,u4,s4,c4 #cgi;dd7m77 is am5d$ by  
/rik+ are held 9 sep>ate acc\nts f funds
 receiv$ f entities "u subsection 7i7 & 
ins]t+ are manag$ z individual          
programmatic funds "u subsection 7i71   
accord+ to be/ acc\nt+ practices4  #g4  
,,nih rese>* in=mation collection       
exempt$ f ,pap]work ,r$uction ,act      
,section #cja ( ! ,public ,heal? ,s]vice
 ,act 7#db ,u4,s4,c4 #bda7 is am5d$ by  
add+ to ! end ! foll[+3  7f7 ,pap]work  
r$uction ,sub*apt] ,i ( *apt] #ce (     
title #dd1 ,unit$ ,/ates ,code1 %all n  

apply to ! collection ( in=mation dur+ !
 conduct ( rese>* by ! ,national        
,in/itutes ( ,heal?4  4  #h4 ,/udies ,! 
,f$]al ,food1 ,drug1 & ,cosmetic ,act is
 am5d$-- 7#a7 9 section #eje7k77#e7 7#ba
 ,u4,s4,c4 #cee7k77#e77--  7,a7 9       
subp>agraph 7,a71 by ins]t+ & aft] !    
semicolon2  7,b7 by /rik+ subp>agraph   
7,b72 &  7,c7 by r$esignat+ subp>agraph 
7,c7 z subp>agraph 7,b72  7#b7 9 section
 #eje;,a 7#ba ,u4,s4,c4 #cee;a71 by     
/rik+ subsection 7p72  7#c7 9 section   
#eje;,b 7#ba ,u4,s4,c4 #cee;c7-- 7,a7 by
 /rik+ subsection 7l72 &  7,b7 by       
r$esignat+ subsection 7m7 z subsection  
7l72 &  7#d7 9 section #ebc 7#ba        
,u4,s4,c4 #cfjm71 by /rik+ subsection   
7d74  #i4 ,summ>y level review ,section 
#eje7;c7 ( ! ,f$]al ,food1 ,drug1 &     
,cosmetic ,act 7#ba ,u4,s4,c4 #cee7;c77 
is am5d$ by add+ at ! end ! foll[+3     
7#e7 7,a7 ,! ,secret>y may rely ^u      
qualifi$ data summ>ies to support !     
approval ( a supplem5tal application1 ) 
respect to a qualifi$ indication = a    

drug1 submitt$ "u subsection 7b7 or     
section #cea7;a7 ( ! ,public ,heal?     
,s]vice ,act1 if su* supplem5tal        
application complies ) subp>agraph 7,b74
  7,b7 ,a supplem5tal application is    
eligible = review z describ$ 9          
subp>agraph 7,a7 only if-- 7i7 !re is   
exi/+ data available & acceptable to !  
,secret>y demon/rat+ ! safety ( ! drug2 
&  7ii7 all data us$ to develop !       
qualifi$ data summ>ies are submitt$ to !
 ,secret>y z "p ( ! supplem5tal         
application4  7,c7 ,9 ?is p>agraph-- 7i7
 ! t]m qualifi$ indication means an     
indication = a drug t ! ,secret>y       
det]m9es to be appropriate = summ>y     
level review "u ?is p>agraph2 &  7ii7 ! 
t]m qualifi$ data summ>y means a summ>y 
( cl9ical data t demon/rates ! safety & 
effectiv5ess ( a drug ) respect to a    
qualifi$ indication4  4  #aj4 ,drug     
surveillance  7a7 ,new drugs ,section   
#eje7k77#e7 ( ! ,f$]al ,food1 ,drug1 &  
,cosmetic ,act 7#ba ,u4,s4,c4           
#cee7k77#e771 z am5d$ by section #h1 is 

fur!r am5d$--  7#a7 9 subp>agraph 7,a71 
by /rik+ 1 bi-weekly scre5+ & ins]t+    
scre5+s2  7#b7 9 subp>agraph 7,b71 z    
r$esignat$ by section #h7a77;,c71 by    
/rik+ ! p]iod at ! end & ins]t+ 2 &2 &  
7#c7 by add+ at ! end ! foll[+3  7,c7   
make available on ! ,int]net website ( !
 ,food & ,drug ,adm9i/ration--  7i7     
guidel9es1 develop$ ) input f exp]ts    
qualifi$ by sci5tific tra9+ & exp]i5ce  
to evaluate ! safety & effectiv5ess (   
drugs1 t detail be/ practices = drug    
safety surveillance us+ ! ,,fda ,adv]se 
,ev5t ,report+ ,sy/ems2 &  7ii7 crit]ia 
= public po/+ ( adv]se ev5t signals4  4 
7b7 ,,fa]s revision ,section            
#eje7r77#b77;,d7 ( ! ,f$]al ,food1      
,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4  
#cee7r77#b77;,d77 is am5d$ by /rik+ 81  
by #ah mon?s0 & all t foll[s ?r\gh !    
semicolon at ! end ( ! subp>agraph &    
ins]t+ & mak+ publicly available on !   
,int]net ,web site e/abli%$ "u p>agraph 
7#a7 be/ practices = drug safety        
surveillance activities = drugs newly   

approv$ "u ?is section or section #cea (
 ! ,public ,heal? ,s]vice ,act24  7c7   
,risk evaluation & mitigation /rategies 
,section #eje-a7;f77#e7 ( ! ,f$]al      
,food1 ,drug1 & ,cosmetic ,act 7#ba     
,u4,s4,c4 #cee-a7;f77#e77 is am5d$--    
7#a7 9 ! matt] prec$+ subp>agraph 7,a71 
by ins]t+ or o!r advisory committee aft]
 7or successor committee72 &  7#b7 9    
subp>agraph 7,b71 by /rik+ at lea/      
annually1 & ins]t+ p]iodically4  #aa4   
,biological product innovation ,section 
#cea7;j7 ( ! ,public ,heal? ,s]vice ,act
 7#db ,u4,s4,c4 #bfb7;j77 is am5d$ by   
/rik+ except t & all t foll[s ?r\gh !   
p]iod at ! end & ins]t+ 8except t--     
7#a7 a product = :i* a lic5se has be5   
approv$ "u ?is section %all n be requir$
 to h an approv$ application "u section 
#eje ( su* ,act2 &  7#b7 ^? provisions (
 ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act
 t ref] to an (ficial comp5dium z def9$ 
"u section #bja7;j7 ( su* ,act %all n   
apply to a biological product subject to
 regulation "u ?is section4  4  #ab4    

,exp&$ access policy ,*apt] ,v ( !      
,f$]al ,food1 ,drug1 & ,cosmetic ,act is
 am5d$ by ins]t+ aft] section #efa 7#ba 
,u4,s4,c4 #cfj;bbb7 ! foll[+3  #efa;,a4 
,exp&$ access policy requir$ =          
inve/igational drugs  7a7 ,9 g5]al ,!   
manufactur] or di/ributor ( "o or m     
inve/igational drugs = ! diagnosis1     
cure1 mitigation1 treatm5t1 or prev5tion
 ( "o or m s]i\s diseases or conditions 
%all make available ! policy ( !        
manufactur] or di/ributor on evaluat+ & 
respond+ to reque/s submitt$ "u section 
#efa7;b7 = provision ( su* a drug4  7b7 
,public availability ( exp&$ access     
policy ,! policies "u subsection 7a7    
%all be made public & readily available1
 su* z by po/+ su* policies on a        
publicly available ,int]net website4    
,su* policies may be g5]ally applicable 
to all inve/igational drugs ( su*       
manufactur] or di/ributor4  7c7 ,cont5t 
( policy ,a policy describ$ 9 subsection
 7a7 %all include-- 7#a7 contact        
in=mation = ! manufactur] or di/ributor 

to facilitate communication ab\t reque/s
 describ$ 9 subsection 7a72  7#b7       
proc$ures = mak+ su* reque/s2  7#c7 !   
g5]al crit]ia ! manufactur] or          
di/ributor w use to evaluate su* reque/s
 = individual pati5ts1 & = responses to 
su* reque/s2 &  7#d7 ! l5g? ( "t !      
manufactur] or di/ributor anticipates w 
be necess>y to ackn[l$ge receipt ( su*  
reque/s4  7d7 ,no gu>antee ( access ,!  
po/+ ( policies by manufactur]s &       
di/ributors "u subsection 7a7 %all n    
s]ve z a gu>antee ( access to any       
specific inve/igational drug by any     
individual pati5t4  7e7 ,revis$ policy  
,no?+ 9 ?is section %all prev5t a       
manufactur] or di/ributor f revis+ a    
policy requir$ "u ?is section at any "t4
  7f7 ,application ,?is section %all    
apply to a manufactur] or di/ributor )  
respect to an inve/igational drug beg9n+
 on ! lat] (--  7#a7 ! date t is #fj    
cal5d> days aft] ! date ( enactm5t ( !  
,,fda & ,,nih ,work=ce ,au?orities      
,mod]nization ,act2 or  7#b7 ! fir/     

initiation ( a phase #b or phase #c /udy
 7z su* t]ms are def9$ 9 section        
#cab4ba7;b7 & 7c7 ( title #ba1 ,code (  
,f$]al ,regulations 7or any successor   
regulations77 ) respect to su*          
inve/igational drug4  4  #ac4 ,f9aliz+  
draft guidance on exp&$ access  7a7 ,9  
g5]al ,n lat] ?an #a ye> aft] ! date (  
enactm5t ( ?is ,act1 ! ,secret>y (      
,heal? & ,human ,s]vices %all f9alize ! 
draft guidance entitl$ ,exp&$ ,access to
 ,inve/igational ,drugs = ,treatm5t     
,use--,qs  ,z1 dat$ ,may #bjac4  7b7    
,cont5ts ,! f9al guidance describ$ 9    
subsection 7a7 %all expla9 h[ !         
,secret>y ( ,heal? & ,human ,s]vices    
consid]s & uses adv]se drug ev5t data   
report$ by inve/igators 9 ! case ( data 
report$ f use "u a reque/ submitt$ "u   
section #efa7;b7 ( ! ,f$]al ,food1      
,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4  
#cfj;bbb7b774  #ad4 ,am5dm5ts to !      
,orphan ,drug ,act ,section #e ( !      
,orphan ,drug ,act 7#ba ,u4,s4,c4       
#cfj;ee7 is am5d$-- 7#a7 9 subsection   

7a71 by /rik+ p>agraph 7#a7 & ins]t+ !  
foll[+3 7#a7 defray+ ! co/s ( develop+  
drugs = r>e diseases or conditions1     
includ+ qualifi$ te/+ exp5ses1 2 &  7#b7
 9 subsection 7b77#a7-- 7,a7 9          
subp>agraph 7,a77ii71 by /rik+ 8&0 aft] 
! semicolon2  7,b7 9 subp>agraph 7,b71  
by /rik+ ! p]iod & ins]t+ 82 &02 &  7,c7
 by add+ at ! end ! foll[+3  7,c7       
prospectively plann$ & design$          
obs]vational /udies & o!r analyses      
conduct$ to assi/ 9 ! und]/&+ ( !       
natural hi/ory ( a r>e disease or       
condition & 9 ! developm5t ( a !rapy1   
includ+ /udies & analyses to--  7i7     
develop or validate a drug developm5t   
tool relat$ to a r>e disease or         
condition2 or  7ii7 und]/& ! full       
spectrum ( ! disease manife/ations1     
includ+ describ+ g5otypic & ph5otypic   
v>iability & id5tify+ & def9+ di/9ct    
subpopulations affect$ by a r>e disease 
or condition4  4  #ae4 ,/&>ds =         
reg5]ative m$ic9e & advanc$ !rapies     
,sub*apt] ,a ( *apt] ,v ( ! ,f$]al      

,food1 ,drug1 & ,cosmetic ,act 7#ba     
,u4,s4,c4 #cea et seq47 is am5d$ by     
ins]t+ aft] section #ejf;,f ! foll[+3   
#ejf;,g4 ,/&>ds = reg5]ative m$ic9e &   
advanc$ !rapies  7a7 ,9 ,g5]al ,!       
,secret>y1 9 consultation ) ! ,national 
,in/itute ( ,/&>ds & ,te*nology &       
/akehold]s 7includ+ reg5]ative m$ic9e & 
advanc$ !rapies manufactur]s & cl9ical  
trial sponsors1 contract manufactur]s1  
academic in/itutions1 practic+          
cl9icians1 reg5]ative m$ic9e & advanc$  
!rapies indu/ry organizations1 & /&>d   
sett+ organizations71 %all facilitate an
 ef=t to coord9ate & prioritize !       
developm5t ( /&>ds1 ?r\gh a transp>5t   
public process1 t w help support product
 developm5t1 evaluation1 & review1 )    
respect to reg5]ative m$ic9e & advanc$  
!rapies1 ?r\gh regulatory pr$ictability1
 includ+ ) reg>d to manufactur+         
processes & controls = reg5]ative m$ic9e
 & advanc$ !rapies products4  7b7       
,activities  7#a7 ,9 ,g5]al ,9 c>ry+ out
 ?is section1 ! ,secret>y %all cont9ue  

to-- 7,a7 id5tify opportunities to help 
advance ! developm5t ( reg5]ative m$ic9e
 & advanc$ !rapies2  7,b7 id5tify       
opportunities = ! developm5t (          
laboratory regulatory sci5ce rese>* &   
docum5t>y /&>ds t ! ,secret>y det]m9es  
w\ld help support ! developm5t1         
evaluation1 & review ( reg5]ative m$ic9e
 & advanc$ !rapies ?r\gh regulatory     
pr$ictability2 &  7,c7 "w ) /akehold]s1 
su* z ^? describ$ 9 subsection 7a71 z   
appropriate1 9 ! developm5t ( su* /&>ds4
  7#b7 ,regulations & guidance ,aft] !  
developm5t ( /&>ds z describ$ 9         
subsection 7a71 ! ,secret>y %all review 
relevant regulations & guidance &1 ?r\gh
 a transp>5t public process1 update su* 
regulations & guidance z ! ,secret>y    
det]m9es appropriate4  7c7 ,def9ition ,=
 purposes ( ?is section1 ! t]m          
#8reg5]ative m$ic9e & advanc$ !rapies'  
includes cell !rapy1 g5e !rapy1         
g5e-modifi$ cell !rapy1 !rapeutic tissue
 eng9e]+ products1 human cell & tissue  
products1 & comb9ation products us+ any 

su* !rapies or products4  4  #af4 ,good 
guidance practices  7a7 ,9 ,g5]al       
,section #gja7;h77#a77;,c7 ( ! ,f$]al   
,food1 ,drug1 & ,cosmetic ,act 7#ba     
,u4,s4,c4 #cga7;h77#a77;,c77 is am5d$-- 
7#a7 by mov+ ! m>g9 ( clause 7ii7 #b ems
 to ! left2 &  7#b7 by add+ at ! end !  
foll[+3  7iii7 ,:5 propos+ or f9aliz+   
any guidance docum5t "u ?is subp>agraph1
 ! ,secret>y %all include 9 ! guidance  
docum5t a /atem5t1 ! cont5ts ( :i* are  
committ$ to ! discretion ( ! ,secret>y--
  7,i7 expla9+ :y ! int]pretation or    
policy set =? 9 su* guidance docum5t is 
be+ provid$ 9 a nonb9d+ guidance docum5t
 & n e/abli%$ ?r\gh rulemak+2 &  7,,ii7 
id5tify+ ea* specific /atutory provision
 or regulation be+ int]pret$ 9 !        
guidance docum5t or au?oriz+ a policy   
decision describ$ 9 ! guidance docum5t4 
4  7b7 ,effective date ,! am5dm5t made  
"u subsection 7a77#b7 %all take effect )
 respect to any applicable guidance     
docum5ts t are issu$ on or aft] ! date t
 is #c mon?s aft] ! date ( enactm5t (   

?is ,act4  #ag4 ,pap]work ,r$uction ,act
 ,waiv] ,dur+ a ,public ,heal? ,em]g5cy 
,section #cai ( ! ,public ,heal? ,s]vice
 ,act 7#db ,u4,s4,c4 #bdg;d7 is am5d$ by
 add+ at ! end ! foll[+3  7f7           
,det]m9ation ) respect to pap]work      
r$uction act waiv] dur+ a public heal?  
em]g5cy  7#a7 ,det]m9ation ,if !        
,secret>y det]m9es1 aft] consultation ) 
su* public heal? (ficials z may be      
necess>y1 t--  7,a7  7i7 ! crit]ia set  
=? = a public heal? em]g5cy "u p>agraph 
7#a7 or 7#b7 ( subsection 7a7 has be5   
met2 or  7ii7 a disease or disord]1     
includ+ a novel & em]g+ public heal?    
?reat1 is significantly likely to become
 a public heal? em]g5cy2 &  7,b7 !      
circum/ances ( su* public heal? em]g5cy1
 or pot5tial = su* significantly likely 
public heal? em]g5cy1 includ+ ! specific
 prep>ation = & response to su* public  
heal? em]g5cy or ?reat1 necessitate a   
waiv] f ! requirem5ts ( sub*apt] ,i (   
*apt] #ce ( title #dd1 ,unit$ ,/ates    
,code 7commonly ref]r$ to z ! ,pap]work 

,r$uction ,act72  !n ! requirem5ts ( su*
 sub*apt] ,i ) respect to volunt>y      
collection ( in=mation %all n be        
applicable dur+ ! imm$iate inve/igation 
(1 & response to1 su* public heal?      
em]g5cy dur+ ! p]iod ( su* public heal? 
em]g5cy or ! p]iod ( "t necess>y to     
det]m9e if a disease or disord]1 includ+
 a novel & em]g+ public heal? ?reat1 w  
become a public heal? em]g5cy z provid$ 
= 9 ?is p>agraph4 ,! requirem5ts ( su*  
sub*apt] ,i ) respect to volunt>y       
collection ( in=mation %all n be        
applicable dur+ ! imm$iate po/-response 
review reg>d+ su* public heal? em]g5cy  
if su* imm$iate po/-response review does
 n exce$ a reasonable l5g? ( "t4  7#b7  
,transp>5cy ,if ! ,secret>y det]m9es t a
 waiv] is necess>y "u p>agraph 7#a71 !  
,secret>y %all promptly po/ on !        
,int]net website ( ! ,dep>tm5t ( ,heal? 
& ,human ,s]vices a brief ju/ification =
 su* waiv]1 ! anticipat$ p]iod ( "t su* 
waiv] w be 9 effect1 & ! ag5cies &      
(fices )9 ! ,dep>tm5t ( ,heal? & ,human 

,s]vices to :i* su* waiv] %all apply1 & 
update su* in=mation po/$ on ! ,int]net 
website ( ! ,dep>tm5t ( ,heal? & ,human 
,s]vices1 z applicable4  7#c7           
,effectiv5ess ( waiv] ,any waiv] "u ?is 
subsection %all take effect on ! date on
 :i* ! ,secret>y po/s in=mation on !    
,int]net website z provid$ = 9 ?is      
subsection4  7#d7 ,t]m9ation ( waiv] ,^u
 det]m9+ t ! circum/ances necessitat+ a 
waiv] "u p>agraph 7#a7 no long] exi/1 ! 
,secret>y %all promptly update !        
,int]net website ( ! ,dep>tm5t ( ,heal? 
& ,human ,s]vices to reflect ! t]m9ation
 ( su* waiv]4  7#e7 ,limitations  7,a7  
,p]iod ( waiv] ,! p]iod ( a waiv] "u    
p>agraph 7#a7 %all n exce$ ! p]iod ( "t 
= ! relat$ public heal? em]g5cy1 includ+
 a public heal? em]g5cy decl>$ pursuant 
to subsection 7a71 & any imm$iate       
po/-response review reg>d+ ! public     
heal? em]g5cy consi/5t ) ! requirem5ts (
 ?is subsection4  7,b7 ,subsequ5t       
compliance ,an initiative subject to a  
waiv] "u p>agraph 7#a7 t is ongo+ aft] !

 date on :i* ! waiv] expires1 %all be   
subject to ! requirem5ts ( sub*apt] ,i (
 *apt] #ce ( title #dd1 ,unit$ ,/ates   
,code1 & ! ,secret>y %all ensure t      
compliance ) su* requirem5ts occurs 9 z 
timely a mann] z possible bas$ on !     
applicable circum/ances1 b n to exce$   
#cj cal5d> days aft] ! expiration ( !   
applicable waiv]4  4  #ah4 ,te*nical    
corrections  7a7 ,ref]5ces ,except z    
o!rwise expressly provid$1 :5ev] 9 ?is  
subsection an am5dm5t is express$ 9 t]ms
 ( an am5dm5t to a section or o!r       
provision1 ! ref]5ce %all be consid]$ to
 be made to t section or o!r provision (
 ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act
 7#ba ,u4,s4,c4 #cja et seq474  7b7     
,am5dm5ts  7#a7 ,prohibit$ ,acts        
,section #cja7r7 ( ! ,act 7#ba ,u4,s4,c4
 #cca7r77 is am5d$ by ins]t+ 1 drug1    
aft] device ea* place ! t]m appe>s4     
7#b7 ,new ,drugs ,section #eje ( ! ,act 
7#ba ,u4,s4,c4 #cee7 is am5d$--  7,a7 9 
subsection 7d71 9 ! la/ s5t5ce1 by /rik+
 prem>ket approval & ins]t+ m>ket+      

approval2 &  7,b7 9 subsection          
7q77#e77;,a71 by /rik+ subsection       
7b77#b7 or 7j7 ( ! ,act or #cea7k7 &    
ins]t+ subsection 7b77#b7 or 7j7 ( ?is  
section or section #cea7k74  7#c7 ,risk 
evaluation & mitigation /rategies       
,section #eje-a7;h7 ( ! ,act 7#ba       
,u4,s4,c4 #cee-a7;h77 is am5d$-- 7,a7 9 
p>agraph 7#b77;,a77iii7--  7i7 9 !      
clause head+1 by /rik+ label & ins]t+   
label+2  7ii7 by /rik+ label ea* place !
 t]m appe>s & ins]t+ label+2 &  7iii7 by
 /rik+ sponsor & ins]t+ responsible     
p]son2 &  7,b7 9 p>agraph 7#h71 by /rik+
 & 7#g74 & ins]t+ & 7#g74  7#d7         
,p$iatric /udy plans ,section #eje;,b ( 
! ,act 7#ba ,u4,s4,c4 #cee;c7 is am5d$--
 7,a7 9 subsection 7e7--  7i7 9 p>agraph
 7#b7-- 7,i7 9 subp>agraph 7,a71 9 !    
matt] prec$+ clause 7i71 by ins]t+ /udy 
aft] initial p$iatric ea* place ! t]m   
appe>s2 &  7,,ii7 9 subp>agraph 7,b71 9 
! subp>agraph head+1 by /rik+ initial   
plan & ins]t+ initial p$iatric /udy     
plan2  7ii7 9 p>agraph 7#e71 by ins]t+  

agre$ initial p$iatric /udy be=e plan 9 
! p>agraph head+2 &  7iii7 9 p>agraph   
7#f71 by /rik+ agre$ initial p$iatric   
plan & ins]t+ agre$ initial p$iatric    
/udy plan2 &  7,b7 9 subsection 7f77#a71
 by ins]t+ & any significant am5dm5ts to
 su* plans1 aft] agre$ initial p$iatric 
/udy plans14  7#e7 ,discont9uance or    
int]ruption 9 ! production ( live-sav+  
drugs ,section #ejf;,c ( ! ,act 7#ba    
,u4,s4,c4 #cef;c7 is am5d$-- 7,a7 9     
subsection 7c71 by /rik+ discont9uation 
& ins]t+ discont9uance2 &  7,b7 9       
subsection 7g77#a71 by /rik+ section    
#eje7;j7 t c\ld help & ins]t+ section   
#eje7;j71 t c\ld help4  7#f7 ,annual    
report+ on drug %ortages ,section       
#ejf;,c-#a7;a7 ( ! ,act 7#ba ,u4,s4,c4  
#cca7;a77 is am5d$1 9 ! matt] be=e      
p>agraph 7#a7--  7,a7 by /rik+ ,n lat]  
?an ! end ( cal5d> ye> #bjac1 & n lat]  
?an ! end ( ea* cal5d> ye> !reaft]1 &   
ins]t+ ,n lat] ?an ,m>* #ca ( ea* cal5d>
 ye>1 2 &  7,b7 by ins]t+ 1 ) respect to
 ! prec$+ cal5d> ye>1 aft] a report4    

7#g7 ,drug %ortage li/ ,section         
#ejf;,e7b77#c77;,e7 ( ! ,act 7#ba       
,u4,s4,c4 #cef;e7b77#c77;,e77 is am5d$  
by /rik+ discont9uation & ins]t+        
discont9uance4  7#h7 ,inspections (     
e/abli%m5ts ,section #eaj7;h7 ( ! ,act  
7#ba ,u4,s4,c4 #cfj7;h77 is am5d$-- 7,a7
 9 p>agraph 7#d71 9 ! matt] prec$+      
subp>agraph 7,a71 by /rik+ e/abli%+ !   
risk-bas$ s*$ul$ & ins]t+ e/abli%+ a    
risk-bas$ s*$ule2 &  7,b7 9 p>agraph    
7#f7-- 7i7 9 subp>agraph 7,a71 by /rik+ 
fiscal & ins]t+ cal5d> ea* place ! t]m  
appe>s2 &  7ii7 9 subp>agraph 7,b71 by  
/rik+ an active +r$i5t ( a drug1 a f9i%$
 drug product1 or an excipi5t ( a drug &
 ins]t+ an active +r$i5t ( a drug or a  
f9i%$ drug product4  7#i7               
,classification ( devices int5d$ = human
 use ,section #eac7;f77#b77;,a7 ( ! ,act
 7#ba ,u4,s4,c4 #cfj;c7f77#b77;,a77 is  
am5d$--  7,a7 9 clause 7i71 by /rik+ )9 
#cj days2 &  7,b7 9 clause 7iv71 by     
/rik+ l[-mod]ate & ins]t+ l[ to mod]ate4
  7#aj7 ,prem>ket approval ,section     

#eae7;a77#a7 ( ! ,act 7#ba ,u4,s4,c4    
#cfj;e7a77#a77 is am5d$ by /rik+ subject
 to a an ord] & ins]t+ subject to an    
ord]4  7#aa7 ,program to improve !      
device recall sy/em ,section #eah;,a ( !
 ,act 7#ba ,u4,s4,c4 #cfj;h-#a7 is      
am5d$--  7,a7 by /rik+ subsection 7c72 &
  7,b7 by r$esignat+ subsection 7d7 z   
subsection 7c74  7#ab7 ,unique device   
id5tifi] ,section #eai7;f7 ( ! ,act 7#ba
 ,u4,s4,c4 #cfj;i7f77 is am5d$ by /rik+ 
& life su/a9+ & ins]t+ or life su/a9+4  
7#ac7 ,priority review = qualifi$       
infecti\s disease products ,section     
#ebd;,a ( ! ,act 7#ba ,u4,s4,c4         
#cfjn-#a7 is am5d$--  7,a7 by /rik+ ,if 
! ,secret>y & ins]t+ ! foll[+3  7a7 ,9  
,g5]al ,if ! ,secret>y  2  7,b7 by /rik+
 any & ins]t+ ! fir/2 &  7,c7 by add+ at
 ! end ! foll[+3  7b7 ,con/ruction ,no?+
 9 ?is section %all prohibit ! ,secret>y
 f giv+ priority review to a human drug 
application or efficacy supplem5t       
submitt$ = approval "u section #eje7;b7 
t o!rwise meets ! crit]ia = ! ,secret>y 

to grant priority review4  4  7#ad7     
,consultation ) ext]nal exp]ts on r>e   
diseases1 t>get$ !rapies1 & g5etic      
t>get+ ( treatm5ts ,section             
#efi7;a77#b77;,a7 ( ! ,act 7#ba         
,u4,s4,c4 #cfj;bbb-#h7;a77#b77;,a77 is  
am5d$1 9 ! fir/ s5t5ce1 by /rik+        
subsection 7c7 & ins]t+ subsection 7b74 
7#ae7 ,optimiz+ global cl9ical trials   
,section #efi;,a7c7 ( ! ,act 7#ba       
,u4,s4,c4 #cfj;bbb-#h;a7c77 is am5d$ by 
ins]t+ or "u ! ,public ,heal? ,s]vice   
,act aft] ?is ,act4  7#af7 ,use (       
cl9ical inve/igation data f outside !   
,unit$ ,/ates ,section #efi;,b ( ! ,act 
7#ba ,u4,s4,c4 #cfj;bbb-#h;b7 is am5d$  
by /rik+ drug or device & ins]t+ drug1  
biological product1 or device ea* place 
! t]m appe>s4  7#ag7 ,m$ical gases      
def9itions ,section #ege7a77;,h7 ( !    
,act 7#ba ,u4,s4,c4 #cfj;ddd7#a77;,h77  
is am5d$-- 7,a7 by ins]t+ = a new drug  
aft] any p]iod ( exclusivity2 &  7,b7 by
 ins]t+ or any p]iod ( exclusivity = a  
new animal drug "u section              

#eab7;c77#b77;,f71 aft] section         
#eje;,a14  7#ah7 ,regulation ( m$ical   
gases ,section #egf7;a7 ( ! ,act 7#ba   
,u4,s4,c4 #cfj;ddd-#a7;a77 is am5d$--   
7,a7 9 ! matt] prec$+ subp>agraph 7,a7 (
 p>agraph 7#a71 by ins]t+ :o seeks to   
initially introduce or deliv] =         
introduction a designat$ m$ical gas into
 int]/ate comm]ce aft] any p]son2 &     
7,b7 9 p>agraph 7#c7-- 7i7 9 subp>agraph
 7,a7--  7,i7 9 clause 7i77,,viii71 by  
ins]t+ = a new drug aft] any p]iod (    
exclusivity2 &  7,,ii7 9 clause 7ii71 9 
! matt] prec$+ subclause 7,i71 by ins]t+
 ! be=e f9al use2 &  7ii7 9 subp>agraph 
7,b7-- 7,i7 9 clause 7i71 by ins]t+ = a 
new drug aft] any p]iod ( exclusivity2 &
  7,,ii7 9 clause 7ii71 by ins]t+ a     
comma aft] drug product4  7#ai7         
,inapplicability ( drug fees to         
designat$ m$ical gases ,section #egg (  
?is ,act 7#ba ,u4,s4,c4 #cfj;ddd-#b7 is 
am5d$ by ins]t+ or #gdj7;a7 aft] section
 #gcf7;a74  7#bj7 ,conflicts ( int]e/   
,section #gab7;e77#a77;,b7 ( ! ,act 7#ba

 ,u4,s4,c4 #cgi;d-#a7;e77#a77;,b77 is   
am5d$ by /rik+ s]vices & ins]t+ s]vice4 
7#ba7 ,au?ority to assess & use         
biosimil> biological product fees       
,section #gdd;,h7a7 ( ! ,act 7#ba       
,u4,s4,c4 #cgi;j-#eb7;a77 is am5d$--    
7,a7 9 p>agraph 7#a77;,a77v71 by /rik+  
,biosimil>s ,us] ,fee ,act ( #bjab &    
ins]t+ ,biosimil> ,us] ,fee ,act (      
#bjab2 &  7,b7 9 p>agraph 7#b77;,b71 by 
/rik+ ,biosimil>s ,us] ,fee ,act ( #bjab
 & ins]t+ ,biosimil> ,us] ,fee ,act (   
#bjab4  7#bb7 ,regi/ration ( comm]cial  
import]s  7,a7 ,am5dm5t ,section        
#hja7s77#b7 ( ! ,act 7#ba ,u4,s4,c4     
#cha7s77#b77 is am5d$ by add+ at ! end !
 foll[+3  7,d7 ,effective date ,9       
e/abli%+ ! effective date ( !           
regulations "u subp>agraph 7,a71 !      
,secret>y %all1 9 consultation ) !      
,secret>y ( ,homel& ,security act+ ?r\gh
 ,u4,s4 ,cu/oms & ,bord] ,protection1 z 
det]m9$ appropriate by ! ,secret>y (    
,heal? & ,human ,s]vices1 provide a     
reasonable p]iod ( "t = an import] ( a  

drug to comply ) good import] practices1
 tak+ into acc\nt diff]5ces among       
import]s & types ( imports1 includ+ bas$
 on ! level ( risk pos$ by ! import$    
product4  4  7,b7 ,con=m+ am5dm5t       
,section #gad ( ! ,food & ,drug         
,adm9i/ration ,safety & ,innovation ,act
 7,public ,law #aab-add2 #abf ,/at4     
#ajgd7 is am5d$ by /rik+ subsection 7d74
  7#bc7 ,recognition ( =eign gov]nm5t   
inspections ,section #hji7;a77#b7 ( !   
,act 7#ba ,u4,s4,c4 #chd;e7a77#b77 is   
am5d$ by /rik+ conduction & ins]t+      
conduct+4  7#bd7 ,f9d+s relat+ to drug  
approval ,section #ija7;a77#a77;,a7 ( ! 
,food & ,drug ,adm9i/ration ,safety &   
,innovation ,act 7,public ,law #aab-add2
 #ba ,u4,s4,c4 #cef note7 is am5d$ by   
/rik+ s]i\s & life-?reat5+ diseases &   
ins]t+ s]i\s or life-?reat5+ diseases4  
7#be7 ,report+ ( inclusion ( demographic
 subgr\ps ,section #ijg ( ! ,food &     
,drug ,adm9i/ration ,safety &           
,innovation ,act 7,public ,law #aab-add2
 #abf ,/at4 #ajib1 #ajic7 is am5d$--    

7,a7 9 ! section head+1 by /rik+        
,biologics 9 ! head+ & ins]t+           
,biological ,products2 &  7,b7 9        
subsection 7a77#b77;,b71 by /rik+       
applications = new drug applications &  
ins]t+ new drug applications4  7#bf7    
,combat+ prescription drug abuse        
,section #aabb ( ! ,food & ,drug        
,adm9i/ration ,safety & ,innovation ,act
 7,public ,law #aab-add2 #abf ,/at4     
#aaab1 #aaac7 is am5d$--  7,a7 9        
subsection 7a77#b71 by /rik+ dep5dance &
 ins]t+ dep5d5ce2 &  7,b7 9 subsection  
7c71 by /rik+ promulgate & ins]t+ issue4
  ,april #ah1 #bjaf,report$ ) an am5dm5t