,i  #aac? ,,congress  #a/ ,session  ,h4 
,r4 #hbj  ,,9 ,,! ,,h\se ,,(            
,,repres5tatives  ,febru>y #bf1 #bjac   
,mr4 ,waxman 7= himself & ,ms4          
,slaught]7 introduc$ ! foll[+ bill2 :i* 
0 ref]r$ to ! ,committee on ,en]gy &    
,comm]ce  ,a ,,bill  ,to am5d ! ,f$]al  
,food1 ,drug1 & ,cosmetic ,act to       
enhance ! report+ requirem5ts p]ta9+ to 
use ( antimicrobial drugs 9 food        
animals4  #a4 ,%ort title ,?is ,act may 
be cit$ z ! ,deliv]+ ,antimicrobial     
,transp>5cy 9 ,animals ,act ( #bjac4    
#b4 ,f9d+s ,! ,congress f9ds ! foll[+3  
7#a7 ,antimicrobials are ( critical     
importance to public heal? & to !       
,am]ican economy4  7#b7 ,use (          
antimicrobials1 :e!r 9 human m$ic9e or 9
 agriculture1 contributes to !          
developm5t & spread ( antimicrobial     
resi/ance4  7#c7 ,data f ! ,food & ,drug
 ,adm9i/ration 7,,fda7 indicate t       
approximately #hj p]c5t ( all           
antimicrobials sold 9 ! ,unit$ ,/ates1  
ov] #bi1jjj1jjj p\nds 9 #bjji1 7 sold = 

use 9 food animals4  7#d7 ,a /udy       
publi%$ 9 ,septemb]1 #bjab1 9 ,proce$+s 
( ! ,national ,academy ( ,sci5ces ( !   
,unit$ ,/ates ( ,am]ica f\nd t ev5 l[   
doses ( antimicrobials 9 animal fe$ =   
%ort p]iods ( "t increas$ ! preval5ce ( 
! bact]ia ,e4 coli & ! preval5ce &      
div]sity ( antimicrobial resi/ance g5es 
9 bact]ia 9 pigs4  7#e7 ,public ,law    
#aaj-caf1 ! ,animal ,drug ,us] ,fee     
,am5dm5ts ( #bjjh1 requires produc]s (  
drugs us$ 9 food animals to provide     
specifi$ in=mation annually to ! ,,fda  
on ! sales & indications = use ( su*    
drugs4  7#f7 ,a ,septemb] #bjaa /udy by 
! ,gov]nm5t ,acc\ntability ,(fice f\nd t
 ! data provid$ to ! ,,fda "u ! ,animal 
,drug ,us] ,fee ,am5dm5ts ,act ( #bjjh  
lack$ suffici5t details necess>y to     
analyze tr5ds 9 antimicrobial resi/ance1
 su* z in=mation on actual drug use 9   
specific food-produc+ animal species4   
#c4 ,purpose ,! purpose ( ?is ,act is to
 provide ! ,food & ,drug ,adm9i/ration &
 ! public ) bett] in=mation on ! use (  

antimicrobial drugs 9 animals us$ = food
 to--  7#a7 enable public heal? (ficials
 & sci5ti/s to bett] und]/& & int]pret  
tr5ds & v>iations 9 rates ( microbial   
resi/ance to su* antimicrobial drugs2   
7#b7 improve ! und]/&+ ( ! relation%ip  
betwe5 antimicrobial drug use 9 animals 
us$ = food & antimicrobial drug         
resi/ance 9 microbes 9 & on animals &   
humans2 &  7#c7 id5tify int]v5tions to  
prev5t & control su* antimicrobial drug 
resi/ance4  #d4 ,enhanc$ report+        
requirem5ts  7a7 ,reports ,section      
#eab7l7 ( ! ,f$]al ,food1 ,drug1 &      
,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;b7l77
 is am5d$ by /rik+ p>agraph 7#c7 &      
ins]t+ ! foll[+3  7#c7 7,a7 ,9 ! case ( 
ea* new animal drug describ$ 9 p>agraph 
7#a7 t conta9s an antimicrobial active  
+r$i5t1 ! sponsor ( ! drug %all submit  
an annual report to ! ,secret>y on !    
am\nt ( ea* antimicrobial active +r$i5t 
9 ! drug t is sold or di/ribut$ = use 9 
food-produc+ animals1 includ+ in=mation 
on any di/ributor-label$ product4  7,b7 

,ea* report "u ?is p>agraph %all specify
 ! am\nt ( ea* antimicrobial active     
+r$i5t--  7i7 by conta9] size1 /r5g?1 & 
dosage =m2  7ii7 by quantities di/ribut$
 to ea* ,/ate dome/ically & by          
quantities export$2 &  7iii7 by dosage  
=m1 includ+ 7= ea* dosage =m7 ! kn[n or 
e/imat$ am\nts ( ! antimicrobial active 
+r$i5t sold or di/ribut$ = use 9 ea*    
food-produc+ animal = :i* ! new animal  
drug is approv$1 includ+ a description (
 ! me?ods us$ to det]m9e or e/imate !   
am\nts4  7#d7 7,a7 ,subject to          
subp>agraph 7,b71 9 ! case ( animal fe$ 
9 f9al =mulation be>+ or conta9+ a new  
animal drug = :i* report+ is requir$ "u 
p>agraph 7#c71 a live p\ltry deal]1 sw9e
 contractor1 or fe$ lot op]ator :o      
pur*ases1 contracts1 or manufactures su*
 fe$ %all submit to ! ,secret>y an      
annual report t specifies1 by           
food-produc+ animal = :i* ! new animal  
drug is approv$ &1 :]e applicable z     
det]m9$ by ! ,secret>y1 by production   
class ( su* animal--  7i7 ! am\nt ( ea* 

antimicrobial active +r$i5t conta9$ p]  
kilogram ( ea* su* fe$ sold or di/ribut$
 = t animal &1 :]e applicable1          
production class2  7ii7 ! quantity ( su*
 fe$ sold or di/ribut$ = t animal &1 :]e
 applicable1 production class2 &  7iii7 
= ea* su* fe$ sold or di/ribut$ "u a    
vet]9>y fe$ directive--  7,i7 !         
indications = :i* ! fe$ 0 sold or       
di/ribut$ & ! quantities ( su* fe$ t 7  
sold or di/ribut$ p] ea* su* indication2
  7,,ii7 ! numb] ( individuals ( !      
food-produc+ animal &1 :]e applicable1 !
 production class to :i* ! fe$ 0 int5d$2
 &  7,,iii7 ! l5g? ( "t ov] :i* ! fe$ 0 
int5d$ to be provid$ to ! animals & !   
dose ( ! active antimicrobial +r$i5t !  
animals 7 int5d$ to receive4  7,b7 7i7  
,subp>agraph 7,a7 does n apply to a live
 p\ltry deal]1 sw9e contractor1 or fe$  
lot op]ator if ! total value ( ! live   
animals own$1 pur*as$1 sold1 contract$  
=1 or o!rwise controll$ by ! deal]1     
contractor1 or op]ator1 directly or     
?r\gh subsidi>ies or affiliates1 p] ye>1

 does n exce$--  7,i7 #aj1jjj1jjj2 or   
7,,ii7 su* o!r sum z ! ,secret>y may    
specify ?r\gh regulation4  7ii7 ,!      
,secret>y may specify ?r\gh regulation  
alt]native report+ requirem5ts1 includ+ 
via pilot programs or bas$ on ! results 
( pilot programs--  7,i7 to improve !   
accuracy ( reports2  7,,ii7 to less5 !  
burd5 ( report+2  7,,iii7 to facilitate 
! ,secret>y's ability to provide public 
summ>ies ( ! reports2 or  7,,iv7 to     
improve ! ,secret>y's ability to use !  
reports1 or ! public's ability to use ! 
summ>ies "u p>agraph 7#e71 to und]/& !  
relation%ip betwe5 sales1 di/ribution1 &
 end-use practices ) respect to fe$     
conta9+ new animal drugs describ$ 9     
p>agraph 7#a7 & antimicrobial resi/ance 
tr5ds 9 microbes 9 animals1 animal food 
products1 & humans4  7#e7 7,a7 ,ea*     
report "u p>agraph 7#c7 or 7#d7 %all--  
7i7 be submitt$ electronically n lat]   
?an ,m>* #ca ea* ye>2  7ii7 cov] ! p]iod
 ( ! prec$+ cal5d> ye>2  7iii7 include  
sep>ate in=mation = ea* mon? ( su*      

cal5d> ye>2 &  7iv7 be 9 su* =mat z !   
,secret>y may require4  7,b7 ,9 specify+
 a =mat "u subp>agraph 7,a77iv71 !      
,secret>y %all seek to ensure t su* =mat
 enables ! data report$ to be integrat$ 
or o!rwise easily associat$ & comp>$ )  
data f o!r ,f$]al databases conta9+ data
 on--  7i7 drug sales = human use2 &    
7ii7 rates ( antimicrobial resi/ance 9  
bact]ia 9 & on animals1 animal food     
products1 & p4  7,c7 ,! ,secret>y may   
%>e in=mation report$ "u p>agraph 7#c7  
or 7#d7 ) ! ,antimicrobial ,resi/ance   
,task ,=ce e/abli%$ "u section #cai;,e (
 ! ,public ,heal? ,s]vice ,act4  7,d7   
7i7 ,n lat] ?an ,novemb] #cj ea* ye>1 ! 
,secret>y %all make publicly available  
summ>ies ( ! in=mation report$ "u       
p>agraphs 7#c7 & 7#d74  7ii7 ,= ea*     
summ>y "u clause 7i71 except z provid$ 9
 clause 7iii71 ! ,secret>y %all--  7,i7 
report data by antimicrobial drug class2
  7,,ii7 = ea* su* antimicrobial drug   
class1 specify--  7aa7 ! quantity (     
drugs sold or di/ribut$ p] dosage =m2   

7bb7 ! p]c5tage ( drugs sold or         
di/ribut$ ) label$ indications t fall )9
 ea* ( ! foll[+ categories3 gr[?        
promotion1 fe$ effici5cy1 or o!r        
production purposes2 disease prev5tion2 
disease control2 & disease treatm5t2    
7cc7 ! quantity ( drugs sold or         
di/ribut$ p] ea* ( ! foll[+ m>ket+      
categories3 ov]-!-c\nt]1 prescription1 &
 vet]9>y fe$ directive2  7dd7 ! quantity
 ( drugs sold or di/ribut$ p] ,/ate (   
sale or di/ribution2 &  7ee7 ! kn[n or  
e/imat$ quantity ( drugs sold or        
di/ribut$ = ea* food-produc+ animal &1  
:]e feasible1 production class ( su*    
animal2 &  7,,iii7 = ea* fe$ sold or    
di/ribut$ "u a vet]9>y food directive = 
:i* report+ is requir$ "u p>agraph 7#d71
 include ! in=mation report$ pursuant to
 subclauses 7,i71 7,,ii71 & 7,,iii7 (   
p>agraph 7#d77;,a77iii74  7iii7 ,= any  
antimicrobial drug class ) few] ?an #c  
sponsors ( approv$ new animal drugs1    
in/ead ( report+ data "u clause 7ii71 ! 
,secret>y %all = ea* su* class--  7,i7  

report data by category ( importance ( !
 antimicrobial drugs )9 t class to human
 m$ic9e1 z det]m9$ by ! ,secret>y2 &    
7,,ii7 to ! ext5t feasible = ea* su*    
category1 specify--  7aa7 ! quantity (  
drugs sold or di/ribut$ p] dosage =m2   
7bb7 ! p]c5tage ( drugs sold or         
di/ribut$ ) label$ indications t fall )9
 ea* ( ! foll[+ categories3 gr[?        
promotion1 fe$ effici5cy1 or o!r        
production purposes2 disease prev5tion2 
disease control2 & disease treatm5t2    
7cc7 ! quantity ( drugs sold or         
di/ribut$ p] ea* ( ! foll[+ m>ket+      
categories3 ov]-!-c\nt]1 prescription1 &
 vet]9>y fe$ directive2 &  7dd7 !       
quantity ( drugs sold or di/ribut$ p]   
,/ate ( sale or di/ribution4  7iv7 ,9   
c>ry+ out ?is subp>agraph1 ! ,secret>y  
%all report data 9 a mann] consi/5t )   
protect+ bo? national security &        
confid5tial bus9ess in=mation4  7,e7 ,9 
?is p>agraph1 ! t]ms live p\ltry deal] &
 sw9e contractor h ! mean+s giv5 to ^?  
t]ms 9 section #b ( ! ,pack]s &         

,/ocky>ds ,act1 #aiba4  4  7b7 ,rule (  
application ,! am5dm5t made by ?is      
section applies to reports "u p>agraphs 
7#c7 & 7#d7 ( section #eab7l7 ( ! ,f$]al
 ,food1 ,drug1 & ,cosmetic ,act 7#ba    
,u4,s4,c4 #cfj;b7l77 7z am5d$ by        
subsection 7a77 t cov] ! p]iod ( cal5d> 
ye> #bjad or any subsequ5t cal5d> ye>4  
,! provisions ( section #eab7l77#c7 (   
su* ,act1 z 9 effect ! day be=e ! date (
 enactm5t ( ?is ,act1 apply to reports t
 cov] ! p]iod ( cal5d> ye> #bjac4  #e4  
,enhanc$ collaboration betwe5 ! ,food & 
,drug ,adm9i/ration & ! ,dep>tm5t (     
,agriculture ,! ,secret>y ( ,heal? &    
,human ,s]vices1 act+ ?r\gh !           
,commission] ( ,food & ,drugs1 %all     
increase collaboration & coord9ation ) !
 ,secret>y ( ,agriculture to exp& &     
coord9ate ! collection ( data on ! use (
 antimicrobial drugs 9 or on cattle1    
sw9e1 *ick5s1 turkeys1 & su* o!r        
food-produc+ animal species z agre$ to  
by ! ,secret>y ( ,heal? & ,human        
,s]vices & ! ,secret>y ( ,agriculture1  

includ+ by provid+ in=mation to !       
,secret>y ( ,agriculture = use by--     
7#a7 ! ,animal & ,plant ,heal?          
,inspection ,s]vice to help in=m its    
collection ( data ?r\gh ! ,national     
,animal ,heal? ,monitor+ ,sy/em2 &  7#b7
 ! ,economic ,rese>* ,s]vice to help    
in=m its collection ( data ?r\gh !      
,agricultural ,res\rce ,managem5t       
,survey4  #f4 ,action by ,gov]nm5t      
,acc\ntability ,(fice  7a7 ,publication 
( f9al guidance ,n lat] ?an #ahj days   
aft] ! date ( enactm5t ( ?is ,act1 !    
,secret>y ( ,heal? & ,human ,s]vices    
%all publi% a f9al v]sion ( draft       
guidance #bac1 entitl$ ,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 #bji4  7b7    
,report by ,,gao  7#a7 ,9 g5]al ,n lat] 
?an #c ye>s aft] ! publication ( f9al   
guidance pursuant to subsection 7a71 !  

,comptroll] ,g5]al ( ! ,unit$ ,/ates    
%all comm5ce a /udy to evaluate--  7,a7 
! volunt>y approa* us$ by ! ,food &     
,drug ,adm9i/ration to elim9ate         
injudici\s use ( antimicrobial drugs 9  
food-produc+ animals2 &  7,b7 !         
effectiv5ess ( ! data collection        
activities conduct$ by ! ,food & ,drug  
,adm9i/ration reg>d+ antimicrobial      
resi/ance4  7#b7 ,report ,n lat] ?an #a 
ye> aft] comm5c+ ! /udy requir$ by      
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