,i  #aah? ,,congress  #b;d ,session  ,h4
 ,r4 #gbdh  ,,9 ,,! ,,h\se ,,(          
,,repres5tatives  ,febru>y #f1 #bjbd,mr4
 ,c>t] ( ,georgia 7= himself1 ,ms4      
,b>ragn1 ,mrs4 ,h>%b>g]1 ,mr4 ,bu*anan1 
,mr4 ,c>t] ( ,l\isiana1 ,mr4 ,waltz1    
,ms4 ,de,lauro1 ,mr4 ,nehls1 ,mr4 ,good5
 ( ,texas1 ,mr4 ,cr5%aw1 & ,mr4         
,fitzpatrick7 introduc$ ! foll[+ bill2  
:i* 0 ref]r$ to ! ,committee on ,en]gy &
 ,comm]ce  ,a ,,bill  ,to am5d ! ,f$]al 
,food1 ,drug1 & ,cosmetic ,act to       
e/abli% a process = ! qualification (   
noncl9ical te/+ me?ods to r$uce &       
replace ! use ( animals 9 noncl9ical    
rese>*1 improve ! pr$ictivity (         
noncl9ical te/+ me?ods1 & r$uce         
developm5t "t = a biological product or 
o!r drug1 & = o!r purposes4  #a4 ,%ort  
title ,?is ,act may be cit$ z ! ,,fda   
,mod]nization ,act #c4j4  #b4           
,noncl9ical te/+ me?ods qualification   
process at ! ,food & ,drug ,adm9i/ration
  7a7 ,9 g5]al ,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 #ejg ! foll[+3   
#ejg;,a4 ,noncl9ical te/+ me?ods        
qualification process  7a7 ,9 g5]al     
7#a7 ,process description ,! ,secret>y  
%all e/abli% a process = ! qualification
 ( a noncl9ical te/+ me?od1 ) respect to
 drugs1 "u :i*-- 7,a7 p]sons may reque/ 
qualification ( a noncl9ical te/+ me?od 
= a p>ticul> context ( use2 &  7,b7 !   
,secret>y %all grant or d5y su* reque/ 9
 accordance ) ?is section4  7#b7        
,initiation ,! ,secret>y %all initiate !
 process "u p>agraph 7#a7 n lat] ?an #a 
ye> aft] ! date ( enactm5t ( ?is        
section4  7b7 ,eligible noncl9ical te/+ 
me?ods ,to be eligible = qualification  
"u ?is section1 a noncl9ical te/+ me?od 
%all-- 7#a7 be int5d$ to replace or     
r$uce animal te/+2 &  7#b7 ei!r-- 7,a7  
improve ! pr$ictivity ( noncl9ical te/+ 
= safety & efficacy2 or  7,b7 r$uce     
developm5t "t = a drug 7includ+ any     
biological product74  7c7 ,qualification
 ( noncl9ical te/+ me?ods  7#a7 ,process

 ,! ,secret>y %all e/abli% a process =  
submission ( a reque/ "u subsection 7a74
  7#b7 ,cont5ts ,at a m9imum1 a reque/  
"u subsection 7a7 %all include prelim9>y
 in=mation demon/rat+ t ! noncl9ical    
te/+ me?od meets ! crit]ia describ$ 9   
subsection 7b7 9 a p>ticul> context (   
use4  7#c7 ,advice reg>d+ ! me?od (     
noncl9ical te/+ ,! ,secret>y may        
facilitate ! developm5t & review (      
prelim9>y in=mation submitt$ pursuant to
 p>agraph 7#b7 9 a reque/ "u subsection 
7a7 by-- 7,a7 provid+ timely advice to1 
& int]action )1 ! p]son submitt+ !      
reque/ reg>d+ ! developm5t ( ! me?od (  
noncl9ical te/+2 &  7,b7 involv+ s5ior  
manag]s & exp]i5c$ /aff ( ! ,food &     
,drug ,adm9i/ration1 z appropriate1 9 a 
collaborative1 cross-discipl9>y review (
 ! propos$ me?od ( noncl9ical te/+4     
7#d7 ,engagem5t ( ext]nal exp]ts ,9     
review+ a reque/ "u subsection 7a71 !   
,secret>y may-- 7,a7 ?r\gh ! use (      
coop]ative agreem5ts or o!r appropriate 
me*anisms1 consult ) biom$ical rese>*   

consortia & o!r exp]t /akehold]s )      
specific exp]tise 9 noncl9ical te/+     
me?ods2 &  7,b7 consid] recomm5dations (
 biom$ical rese>* consortia or o!r      
qualifi$ exp]ts 9 decid+ :e!r to grant  
or d5y ! reque/4  7#e7 ,review ( reque/s
  7,a7 ,tim+ ,n lat] ?an #ahj cal5d>    
days aft] ! receipt ( a reque/ "u       
subsection 7a71 ! ,secret>y %all det]m9e
 :e!r to grant or d5y ! reque/4  7,b7   
,det]m9ation ,9 review+ a noncl9ical    
te/+ me?od pursuant to a reque/ "u      
subsection 7a71 ! ,secret>y %all det]m9e
 :e!r to grant or d5y ! reque/ bas$ on  
:e!r ! me?od satisfies ! crit]ia li/$ 9 
subsection 7b7 z demon/rat$ by-- 7i7 !  
in=mation submitt$ 9 ! reque/ or        
supplem5ts !reto2 &  7ii7 any additional
 in=mation provid$ by ext]nal exp]ts4   
7,c7 ,qualification decision ,if !      
,secret>y det]m9es pursuant to          
subp>agraph 7,b7 t a noncl9ical te/+    
me?od satisfies ! crit]ia li/$ 9        
subsection 7b71 ! ,secret>y %all grant !
 reque/ = qualification ( ! me?od 9 a   

p>ticul> context ( use4  7d7 ,effects ( 
qualification ,if ! ,secret>y qualifies 
a noncl9ical te/+ me?od pursuant to a   
reque/ "u ?is section-- 7#a7 ! me?od    
%all be available = use by ! hold] ( !  
qualification or a p]son au?oriz$ by su*
 hold] = drug developm5t 9 ! p>ticul>   
context ( use = :i* ! me?od is qualifi$2
 &  7#b7 ! ,secret>y %all-- 7,a7 exp$ite
 ! developm5t & review ( an application 
submitt$ "u section #eje ( ?is ,act or  
section #cea ( ! ,public ,heal? ,s]vice 
,act1 includ+ supplem5tal applications1 
= drugs t are develop$ us+ ! qualifi$   
noncl9ical te/+ me?od2 &  7,b7 all[ !   
hold] ( ! qualification or a p]son      
au?oriz$ by su* hold] to ref]5ce or rely
 ^u1 9 an application submitt$ "u       
section #eje ( ?is ,act or section #cea 
( ! ,public ,heal? ,s]vice ,act1 includ+
 a supplem5tal application1 data &      
in=mation ab\t ! qualification ( !      
noncl9ical te/+ me?od 9 ! same context (
 use = :i* ! qualification 0 grant$4    
7e7 ,review ( applications utiliz+      

qualifi$ noncl9ical te/+ me?ods ,!      
,secret>y %all exp$ite ! developm5t &   
review ( an application submitt$ "u     
section #eje ( ?is ,act or section #cea 
( ! ,public ,heal? ,s]vice ,act = drugs 
= :i* a noncl9ical te/+ me?od qualifi$  
"u ?is section is us$4  7f7 ,transp>5cy 
7#a7 ,submission ( report to ,congress  
,n lat] ?an #b ye>s aft] ! date (       
enactm5t ( ?is section & annually       
!reaft]1 ! ,secret>y %all publi% on !   
website ( ! ,food & ,drug ,adm9i/ration 
& submit to ! ,committee on ,heal?1     
,education1 ,labor1 & ,p5sions ( !      
,s5ate & ! ,committee on ,en]gy &       
,comm]ce ( ! ,h\se ( ,repres5tatives a  
report conta9+ an evaluation ( ! process
 "u ?is section4  7#b7 ,cont5ts ( report
 ,ea* report "u p>agraph 7#a7 %all      
include-- 7,a7 = ! p]iod cov]$ by !     
report-- 7i7 ! types ( noncl9ical te/+  
me?ods qualifi$ "u ! process2  7ii7 !   
numb] ( reque/s = qualification "u      
subsection 7a71 & ! numb] ( su* reque/s 
t h be5 grant$2  7iii7 ! av]age numb] ( 

cal5d> days = ! review ( reque/s "u     
subsection 7a7 be=e grant+ or d5y+ su*  
reque/s2  7iv7 an analysis ( ! factors t
 result 9 det]m9ations to qualify or n  
qualify a noncl9ical te/+ me?od "u ?is  
section2 &  7v7 ! numb] ( applications  
receiv$ "u section #eje ( ?is ,act or   
section #cea ( ! ,public ,heal? ,s]vice 
,act t rely on a noncl9ical te/+ me?od  
qualifi$ "u ?is section1 & ! numb] ( su*
 applications approv$2 &  7,b7 = ! p]iod
 beg9n+ on ! date ( enactm5t ( ?is      
section ?r\gh ! end ( ! p]iod cov]$ by !
 report1 ! numb] ( animals e/imat$ to h 
be5 sav$ z a result ( ! process "u ?is  
section4  7g7 ,noncl9ical te/+ me?od    
def9$ ,9 ?is section1 ! t]m noncl9ical  
te/+ me?od has ! mean+ giv5 to su* t]m 9
 section #eje7z7 except t su* t]m       
excludes any animal te/4  4  7b7 ,public
 meet+ ,n lat] ?an #ahj days aft] ! date
 ( enactm5t ( ?is ,act1 ! ,secret>y (   
,heal? & ,human ,s]vices %all publi% 9 !
 ,f$]al ,regi/] a notice to conv5e a    
public meet+ to discuss & obta9 input & 

recomm5dations f relevant /akehold]s1   
includ+ regulat$ indu/ry1 biom$ical     
consortia1 contract rese>*              
organizations1 & pati5ts1 reg>d+-- 7#a7 
! goals & scope ( ! process "u #ejg;,a (
 ! ,f$]al ,food1 ,drug1 & ,cosmetic     
,act1 z add$ by subsection 7a72  7#b7 a 
framework1 proc$ures1 & requirem5ts =   
su* process2 &  7#c7 ways 9 :i* ! ,food 
& ,drug ,adm9i/ration w support ! use ( 
noncl9ical te/+ me?ods to replace or    
r$uce ! use ( animals 9 noncl9ical te/+4
  7c7 ,,fda guidance  7#a7 ,noncl9ical  
te/+ me?ods qualification process ,!    
,secret>y ( ,heal? & ,human ,s]vices1   
act+ ?r\gh ! ,commission] ( ,food &     
,drugs1 %all-- 7,a7 n lat] ?an #a ye>   
aft] ! date ( ! public meet+ "u         
subsection 7b71 propose guidance on !   
goals & implem5tation ( ! process "u    
section #ejg;,a ( ! ,f$]al ,food1 ,drug1
 & ,cosmetic ,act1 z add$ by subsection 
7a72  7,b7 provide a p]iod = public     
comm5t on su* propos$ guidance2 &  7,c7 
n lat] ?an #a ye> aft] ! end ( su*      

public comm5t p]iod1 f9alize su*        
guidance4  7#b7 ,cont5ts ,! guidance "u 
p>agraph 7#a7 %all address-- 7,a7 !     
process by :i* a p]son may reque/       
qualification "u section #ejg;,a ( !    
,f$]al ,food1 ,drug1 & ,cosmetic ,act1 z
 add$ by subsection 7a72  7,b7 !        
eligibility crit]ia "u subsection 7b7 ( 
su* section #ejg;,a2  7,c7 ! in=mation t
 a p]son reque/+ su* qualification is   
requir$ to submit "u subsection 7c7 (   
su* section #ejg;,a2 &  7,d7 h[ !       
,secret>y int5ds to evaluate reque/s "u 
su* section #ejg;,a4  #c4 ,regulations  
on noncl9ical te/+ me?ods  7a7 ,9 g5]al 
,n lat] ?an #ij days aft] ! date (      
enactm5t ( ?is ,act1 ! ,secret>y (      
,heal? & ,human ,s]vices1 act+ ?r\gh !  
,commission] ( ,food & ,drugs1 %all     
initiate a rulemak+ "u section #eec (   
title #e1 ,unit$ ,/ates ,code1 to       
implem5t section #eje7z7 ( ! ,f$]al     
,food1 ,drug1 & ,cosmetic ,act 7#ba     
,u4,s4,c4 #cee7z774  7b7 ,te*nical      
am5dm5t ,section #eje ( ! ,f$]al ,food1 

,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4  
#cee7 is am5d$ by designat+ ! second    
subsection 7z7 7relat+ to cl9ical trial 
div]sity action plans71 z add$ by       
section #cfja7;a7 ( ! ,heal? ,ext5d]s1  
,improv+ ,access to ,m$ic>e1 ,m$icaid1 &
 ,,*ip1 & ,/r5g!n+ ,public ,heal? ,act (
 #bjbb 7division ,,ff ( ,public ,law    
#aag-cbh71 z subsection 7aa74