,,ii  #aac? ,,congress  #a/ ,session    
,s4 #hie  ,,9 ,,! ,,s5ate ,,( ,,!       
,,unit$ ,,/ates  ,may #h1 #bjac ,mrs4   
,gillibr& 7= h]self1 ,mrs4 ,fe9/e91 &   
,ms4 ,coll9s7 introduc$ ! foll[+ bill2  
:i* 0 read twice & ref]r$ to !          
,committee on ,heal?1 ,education1       
,labor1 & ,p5sions  ,a ,,bill  ,to      
improve ! ability ( ! ,food & ,drug     
,adm9i/ration to /udy ! use (           
antimicrobial drugs 9 food-produc+      
animals4  #a4 ,%ort title ,?is ,act may 
be cit$ z ! ,antimicrobial ,data        
,collection ,act4  #b4 ,rese>* programs 
to /udy antimicrobial resi/ance  7a7    
,def9itions ,9 ?is ,act--  7#a7 ! t]m   
,commission] means ! ,commission] (     
,food & ,drugs2 &  7#b7 ! t]m ,secret>y 
means ! ,secret>y ( ,heal? & ,human     
,s]vices4  7b7 ,comm5cem5t ( pilot data 
collection & analysis program ,!        
,secret>y1 act+ ?r\gh ! ,commission]1   
%all develop a rese>* program or        
programs to /udy ! relation%ip betwe5 ! 
sales1 di/ribution1 end-use practices ( 

animal drugs conta9+ an antimicrobial   
active +r$i5t 9 food-produc+ animals &  
antimicrobial resi/ance tr5ds4 ,!       
,secret>y may also consid] any o!r      
available s\nd in=mation1 sci5ce1       
rese>*1 exp]tise1 or program designs 9  
c>ry+ out ?is subsection4  7c7 ,purpose 
( programs ,any rese>* program develop$ 
"u subsection 7b7 %all be develop$ 9    
ord] to bett] det]m9e--  7#a7 !         
relation%ips betwe5 sales data1         
di/ribution data1 & end-usage data (    
animal drugs conta9+ an antimicrobial   
active +r$i5t 9 food-produc+ animals to 
in=m policies ( ,food & ,drug           
,adm9i/ration reg>d+ data collection &  
regulation ( antimicrobial products 9   
agriculture1 includ+ consid]ation ( !   
pot5tial value & feasibility ( data f   
vet]9>y fe$ directives & o!r s\rces2 &  
7#b7 ! relation%ips betwe5 ! use (      
animal drugs conta9+ an antimicrobial   
active +r$i5t 9 food-produc+ animals &  
tr5ds 9 antimicrobial resi/ance1 includ+
 by us+ ! data collect$ ?r\gh !         

,national ,antimicrobial ,resi/ance     
,monitor+ ,sy/em or o!r /udies reg>d+   
resi/ance levels 9 bact]ia associat$ )  
food-produc+ animals4  7d7 ,consultation
 ,any rese>* program develop$ "u        
subsection 7b7 %all be develop$ 9       
consultation ) ! ,secret>y (            
,agriculture1 :i* %all include at a     
m9imum consultation ) ! ,"u ,secret>y = 
,food ,safety1 ! ,"u ,secret>y = ,m>ket+
 & ,regulatory ,programs1 & ! ,"u       
,secret>y = ,rese>*1 ,education1 &      
,economics at ! ,dep>tm5t (             
,agriculture4 ,to ! ext5t practicable1  
su* ,"u ,secret>ies %all provide        
assi/ance 9 develop+ & conduct+ su*     
rese>* programs4  7e7 ,implem5tation ,n 
lat] ?an #ahj days aft] ! date (        
enactm5t ( ?is ,act1 ! ,secret>y %all   
implem5t ! rese>* program or programs   
develop$ "u subsection 7b74 ,! ,secret>y
 %all analyze data f su* program or     
programs to det]m9e ! contribution ( su*
 data to /udy+ antimicrobial resi/ance &
 e/abli%+ ! antimicrobial data          

collection /rategy z describ$ 9 section 
#c7;b77#a77;,b74  #c4 ,reports to       
,congress2 developm5t ( data collection 
/rategy  7a7 ,initial report ,z soon z  
practicable aft] ! date ( enactm5t ( ?is
 ,act1 ! ,secret>y %all--  7#a7 submit  
to ,congress a report t--  7,a7         
describes ! rese>* design & goals = !   
rese>* program or programs develop$ "u  
section #b7;b72 &  7,b7 includes a ne$s 
assessm5t1 consid]+ broad s\rces ( data 
& models on antimicrobial use 9         
food-produc+ animals t ! ,food & ,drug  
,adm9i/ration may ne$ or f :i* ! ,food &
 ,drug ,adm9i/ration c\ld b5efit1 to    
improve ! evaluation ( ,food & ,drug    
,adm9i/ration programs reg>d+           
antimicrobial resi/ance & h[ a sy/ematic
 & valid data collection /rategy w be   
design$ to comply ) subsection          
7b77#a77;,b72 &  7#b7 make su* report   
publicly available4  7b7 ,report reg>d+ 
results & recomm5dations ,n lat] ?an #b 
ye>s aft] ! date ( enactm5t ( ?is ,act1 
! ,secret>y %all--  7#a7 submit to      

,congress a report t--  7,a7 describes !
 compreh5sive results ( any rese>*      
program or programs develop$ "u section 
#b7;b71 includ+ ) respect to !          
det]m9ations made pursuant to p>agraphs 
7#a7 & 7#b7 ( section #b7;c72 &  7,b7   
provides recomm5dations = develop+ an   
antimicrobial data collection /rategy   
bas$ on ! in=mation conta9$ 9 ! comm5ts 
to ! ,advanc$ ,notice ( ,propos$        
,rulemak+ entitl$ ,antimicrobial ,animal
 ,drug ,di/ribution ,report+ 7#gg ,f$4  
,reg4 #ddagg 7,july #bg1 #bjab77 & any  
relevant in=mation obta9$ 9 ! rese>*    
pilot program c>ri$ out "u section #b2 &
  7#b7 make su* report publicly         
available4  #d4 ,enhanc$ report+ &      
publication ( sales data  7a7 ,9 g5]al  
,section #eab7l77#c77;,e7 ( ! ,f$]al    
,food1 ,drug1 & ,cosmetic ,act 7#ba     
,u4,s4,c4 #cfj;b7l77#c77;,e77 is am5d$--
  7#a7 by r$esignat+ clauses 7i7 & 7ii7 
z subclauses 7,i7 & 7,,ii72  7#b7 by    
/rik+ ,! ,secret>y %all make summ>ies ( 
! in=mation report$ "u ?is p>agraph     

publicly available1 except t-- & ins]t+ 
7i7 ,n lat] ?an a date e/abli%$ by !    
,secret>y = #bjad1 & on su* date 9 ea*  
ye> !reaft]1 ! ,secret>y %all make      
publicly available a summ>y ( !         
in=mation 7includ+ dosage =m in=mation1 
if practicable7 report$ "u ?is p>agraph 
= ! previ\s ye>1 except t--2 &  7#c7 by 
ins]t+ aft] subclause 7,,ii71 z         
r$esignat$ by p>agraph 7#a71 ! foll[+3  
7ii7 ,9 mak+ ! summ>ies available "u ?is
 subp>agraph1 ! foll[+ %all apply3  7,i7
 ,! ,secret>y %all segregate !          
categories ( am\nts report$ into !      
foll[+ #b subcategories1 aft]           
consultation ) applicable               
classifications z det]m9$ by !          
,secret>y1 subject to subclause 7,,iv73 
7aa7 ,! volume ( drugs ( importance to  
human m$ic9e4  7bb7 ,! volume ( drugs n 
( importance to human m$ic9e4  7,,ii7 ,z
 practicable1 ! ,secret>y %all segregate
 am\nts report$ into ! foll[+3  7aa7    
,conta9] size4  7bb7 ,/r5g?4  7cc7      
,dosage =m4  7dd7 ,m>ket+ /atus4        

7,,iii7 ,9 any cross-tabulation ( !     
am\nts report$ ) any report+ category1 !
 ,secret>y %all include ! categories ,n 
,indep5d5tly ,report$ & ,n ,indep5d5tly 
,report$ ,export4  7,,iv7 ,e #e ye>s1 ! 
,secret>y %all reevaluate !             
classifications consult$ "u subclause   
7,i7 aft] opportunity = public comm5t4  
7iii7 ,! ,secret>y %all maximize !      
quality1 accuracy1 detail1 & specificity
 ( data made publicly available 9 !     
summ>ies "u ?is subp>agraph1 to ! ext5t 
practicable1 su* z reg>d+ ! type1       
e/imat$ level ( exposure1 & t>get       
animals ( antimicrobial drugs4 ,9 c>ry+ 
out ! prec$+ s5t5ce1 ! ,secret>y may    
provide additional in=mation 9 su*      
summ>ies4  7iv7 ,! ,secret>y %all       
conduct an annual evaluation ( !        
effectiv5ess ( & compliance ) relevant  
policies & programs ( ! ,food & ,drug   
,adm9i/ration reg>d+ antimicrobial drug 
sales = food-produc+ animals1 & use (   
su* drugs & antimicrobial resi/ance1 us+
 valid & robu/ p]=mance metrics4 ,beg9n+

 9 #bjad1 ! ,secret>y %all include ) ea*
 annual summ>y made publicly available  
"u ?is subp>agraph a report t describes 
! results ( ! evaluation conduct$ "u ?is
 clause ) respect to ! prec$+ ye>4  4   
7b7 ,reissuance ,n lat] ?an #c ye>s aft]
 ! date ( enactm5t ( ?is ,act1 !        
,secret>y %all reissue ! summ>y reports 
issu$ be=e #bjab "u section             
#eab7l77#c77;,e7 ( ! ,f$]al ,food1      
,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4  
#cfj;b7l77#c77;,e77 us+ ! =mat design$ =
 ! #bjab summ>y report4 ,! ,secret>y    
%all publi% ! reissu$ reports 9 "o      
comb9$ publication4  #e4 ,action to     
protect public & animal heal?  7a7      
,publication ( f9al guidance  7#a7 ,9   
g5]al ,n lat] ?an #ahj days aft] ! date 
( enactm5t ( ?is ,act1 ! ,secret>y %all 
publi% a f9al v]sion ( ! draft ,volunt>y
 ,guidance #bac ( ! ,food & ,drug       
,adm9i/ration 7entitl$ ,new ,animal     
,drugs & ,new ,animal ,drug ,comb9ation 
,products ,adm9i/]$ 9 or on ,m$icat$    
,fe$ or ,dr9k+ ,wat] ( ,food-,produc+   

,animals3 ,recomm5dations = ,drug       
,sponsors = ,volunt>ily ,align+ ,product
 ,use ,conditions ) ,,gfi #bji74  7#b7  
,effect ( subsection ,no?+ 9 ?is        
subsection %all be con/ru$ to affect any
 o!r obligations ( ! ,food & ,drug      
,adm9i/ration reg>d+ ! au?orities ( su* 
,adm9i/ration to regulate antimicrobial 
drugs & protect public heal?4  7b7      
,report by ,,gao  7#a7 ,9 g5]al ,n lat] 
?an #c ye>s aft] ! conclusion ( ! rese>*
 pilot program or programs develop$ "u  
section #b1 ! ,comptroll] ,g5]al ( !    
,unit$ ,/ates %all comm5ce a /udy to    
evaluate--  7,a7 ! approa*es us$ by !   
,food & ,drug ,adm9i/ration to elim9ate 
injudici\s use ( antimicrobial drugs 9  
food-produc+ animals2 &  7,b7 !         
effectiv5ess ( ! data collection        
activities c>ri$ out by ! ,food & ,drug 
,adm9i/ration reg>d+ antimicrobial      
resi/ance4  7#b7 ,report ,n lat] ?an #a 
ye> aft] comm5c+ ! /udy describ$ 9      
p>agraph 7#a71 ! ,comptroll] ,g5]al ( ! 
,unit$ ,/ates %all submit to !          

,committee on ,heal?1 ,education1       
,labor1 & ,p5sions ( ! ,s5ate & !       
,committee on ,en]gy & ,comm]ce ( !     
,h\se ( ,repres5tatives a report t      
describes ! results ( su* /udy4