,,ii  #aad? ,,congress  #a/ ,session    
,s4 #fba  ,,9 ,,! ,,s5ate ,,( ,,!       
,,unit$ ,,/ates  ,m>* #b1 #bjae,mrs4    
,fe9/e9 7= h]self1 ,ms4 ,coll9s1 ,mrs4  
,gillibr&1 & ,ms4 ,w>r57 introduc$ !    
foll[+ bill2 :i* 0 read twice & ref]r$  
to ! ,committee on ,heal?1 ,education1  
,labor1 & ,p5sions  ,a ,,bill  ,to am5d 
! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 
to ensure ! safety & effectiv5ess (     
m$ically important antimicrobials       
approv$ = use 9 ! prev5tion & control ( 
animal diseases1 9 ord] to m9imize !    
developm5t ( antibiotic-resi/ant        
bact]ia4  #a4 ,%ort title ,?is ,act may 
be cit$ z ! ,prev5t+ ,antibiotic        
,resi/ance ,act ( #bjae4  #b4 ,purpose  
,! purpose ( ?is ,act is to ensure !    
safety & effectiv5ess ( m$ically        
important antimicrobials approv$ = use 9
 ! prev5tion & control ( animal         
diseases1 9 ord] to m9imize ! developm5t
 ( antibiotic-resi/ant bact]ia4  #c4    
,evid5ce ( safety ( m$ically important  
vet]9>y antimicrobials  7a7             

,applications p5d+ or submitt$ aft]     
enactm5t ,section #eab7;d77#a7 ( !      
,f$]al ,food1 ,drug1 & ,cosmetic ,act   
7#ba ,u4,s4,c4 #cfj;b7d77#a77 is am5d$--
  7#a7 9 ! fir/ s5t5ce--  7,a7 9        
subp>agraph 7,h71 by /rik+ or at ! end2 
7,b7 9 subp>agraph 7,i71 by ins]t+ or at
 ! end2 &  7,c7 by ins]t+ aft]          
subp>agraph 7,i7 ! foll[+3  7,j7 )      
respect to a m$ically important         
antimicrobial 7z def9$ 9 subsection     
7q771 ! applicant has fail$ to          
demon/rate t a ,new ,animal ,drug       
,application = an antimicrobial label$ =
 disease prev5tion or control fails to  
meet ! crit]ia 9 subsection             
7q77#b77;,a72  2 &  7#b7 9 ! second     
s5t5ce1 by /rik+ 7,a7 ?r\gh 7,i7 &      
ins]t+ 7,a7 ?r\gh 7,j74  7b7 ,ensur+    
judici\s use 9 animals ( m$ically       
important antimicrobials ,section #eab (
 ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act
 7#ba ,u4,s4,c4 #cfj;b7 is am5d$ by add+
 at ! end ! foll[+3  7q7 ,ensur+        
judici\s use 9 animals ( m$ically       

important antimicrobials  7#a7          
,applicability ,?is subsection applies  
to m$ically important antimicrobials    
approv$ = use 9 a food-produc+ animal-- 
7,a7 7i7 = :i* !re is 9 effect an       
approval ( an application or an         
exemption "u subsection 7b71 7i71 or 7j7
 ( section #eje2 or  7ii7 t is o!rwise  
m>ket$ = human use2  7,b7 = :i* ! ,food 
& ,drug ,adm9i/ration has initiat$ or   
complet$ )drawal or modification ( an   
approv$ label = gr[? promotion1 fe$     
effici5cy1 or o!r production use or     
ov]-!-c\nt] use1 9 accordance ) !       
,guidance = ,indu/ry entitl$1 ,new      
,animal ,drugs & ,new ,animal ,drug     
,comb9ation ,products1 ,adm9i/]$ 9 or on
 ,m$icat$ ,fe$ or ,dr9k+ ,wat] (        
,food-,produc+ ,animals3 ,recomm5dations
 = ,drug ,sponsors = ,volunt>ily ,align+
 ,product ,use ,conditions ) ,,gfi #bji1
 publi%$ 9 ,decemb] #bjac2 &  7,c7 = :i*
 ! ,food & ,drug ,adm9i/ration has      
approv$ a label-- 7i7 = disease control 
or prev5tion at ! same or simil> dosage 

level z applicable = ! approv$          
production use describ$ 9 subp>agraph   
7,b72  7ii7 t does n specify an         
explicitly def9$ duration ( !rapy2 or   
7iii7 specify+ a dosage t is n expect$  
to treat a specific bact]ial pa?og54    
7#b7 ,review ( disease prev5tion &      
control approvals  7,a7 ,9 g5]al ,n lat]
 ?an ,janu>y #a1 #bjag1 ! ,secret>y %all
 initiate a process :]eby--  7i7 n lat] 
?an ,janu>y #a1 #bjah1 a sponsor ( an   
antimicrobial drug describ$ 9 p>agraph  
7#a7 %all submit to ! ,secret>y evid5ce 
demon/rat+ t1 ) respect to su* drug--   
7,i7 !re is evid5ce ( effectiv5ess 9    
controll+ or prev5t+ bact]ial disease2  
7,,ii7 an approv$ use is consi/5t )     
accept$ vet]9>y practice2  7,,iii7 an   
approv$ use is l9k$ to a specific       
etiologic ag5t2  7,,iv7 an approv$ use  
is appropriately t>get$ to animals at   
risk ( develop+ a specific bact]ial     
disease2  7,v7 an approv$ use has an    
explicitly def9$ duration ( !rapy2 &    
7,,vi7 !re is reasonable c]ta9ty ( no   

h>m to human heal? due to ! developm5t (
 antimicrobial resi/ance2 &  7ii7 7,i7  
if ! ,secret>y det]m9es t ! evid5ce     
submitt$ "u clause 7i7 is suffici5t to  
demon/rate t ! drug meets ! requirem5ts 
describ$ 9 subclauses 7,i7 ?r\gh 7,,vi7 
( su* clause1 n lat] ?an ,decemb] #ca1  
#bjah1 ! ,secret>y %all issue a revis$  
label approval = ! antimicrobial drug1 z
 necess>y2 or  7,,ii7 if ! ,secret>y    
det]m9es t ! evid5ce submitt$ "u clause 
7i7 is insuffici5t to demon/rate t !    
drug meets ! requirem5ts describ$ 9     
subclauses 7,i7 ?r\gh 7,,vi7 ( su*      
clause1 n lat] ?an ,decemb] #ca1 #bjah1 
! ,secret>y %all )draw approval ( any   
indication claims describ$ 9 p>agraph   
7#a77;,c7 = :i* ! ,secret>y det]m9es !  
evid5ce is insuffici5t &1 z necess>y1   
issue a revis$ label approval4  7,b7    
,)drawal ( claims ,on or be=e ,janu>y   
#a1 #bjah1 ! sponsor ( a drug describ$ 9
 p>agraph 7#a7 may reque/ ! approval ( !
 ,secret>y to remove any label claim    
describ$ 9 p>agraph 7#a77;,c71 & !      

,secret>y %all approve any su* reque/ &1
 z necess>y1 issue a revis$ label4 ,!   
sponsor %all n be requir$ to submit !   
evid5ce requir$ "u subp>agraph 7,a77i7 )
 respect to any claim s )drawn4  7#c7   
,exemptions ,9 ! case ( a drug t is a   
m$ically important antimicrobial = :i* !
 ,secret>y grants an exemption "u       
section #eje7;i71 ! )drawal ( indication
 claims 9 a food-produc+ animal 9       
accordance ) p>agraph 7#b77;,b7 %all be 
effective on ! date t is #b ye>s aft] ! 
date on :i* ! ,secret>y grants !        
exemption1 unless1 n lat] ?an #b ye>s   
aft] ! date on :i* ! ,secret>y grants ! 
exemption1 ! ,secret>y provides a writt5
 det]m9ation ( int5t to ext5d !         
exemption4  7#d7 ,def9ition ,9 ?is      
subsection1 ! t]m m$ically important    
antimicrobial means a drug t--  7,a7 is 
int5d$ = use 9 food-produc+ animals2 &  
7,b7 is compos$ :olly or p>tly (--  7i7 
any k9d ( p5icill91 tetracycl9e1        
macrolide1 l9cosamide1 /reptogram91     
am9oglycoside1 sulfonamide1             

cephalospor91 or fluoroqu9olone2 or     
7ii7 a drug f an antimicrobial class t  
is li/$ z highly important1 critically  
important1 or important by ! ,_w ,heal? 
,organization 9 ! late/ edition ( its   
publication entitl$ ,critically         
,important ,antimicrobials = ,human     
,m$ic9e 7or a successor publication74  4
  #d4 ,s5se ( ! ,s5ate reg>d+ vet]9>y   
ov]sight ( use ( m$ically important     
antimicrobials  7a7 ,9 g5]al ,x is !    
s5se ( ! ,s5ate t a valid               
vet]9>ian-cli5t-pati5t relation%ip %\ld 
exi/ to ensure t m$ically important     
antimicrobials are us$ 9 food-produc+   
animals 9 a mann] t is consi/5t )       
pr(essionally accept$ be/ practices4    
7b7 ,vet]9>ian-,cli5t-,pati5t           
relation%ip ,9 ?is section1 ! t]m       
vet]9>ian-cli5t-pati5t relation%ip means
 a relation%ip 9 :i* all ( ! foll[+     
crit]ia are met3  7#a7 ,! vet]9>ian has 
assum$ ! responsibility = mak+ m$ical   
judgm5ts reg>d+ ! heal? ( ! pati5t & !  
cli5t has agre$ to foll[ ! vet]9>ian's  

in/ructions4  7#b7 ,! vet]9>ian has     
suffici5t k ( ! pati5t to initiate at   
lea/ a g5]al or prelim9>y diagnosis ( ! 
m$ical condition ( ! pati5t4 ,?is means 
t ! vet]9>ian is p]sonally acqua9t$ ) ! 
keep+ & c>e ( ! pati5t by virtue (--    
7,a7 a timely exam9ation ( ! pati5t by !
 vet]9>ian2 or  7,b7 m$ically           
appropriate & timely visits by !        
vet]9>ian to ! premises :]e ! animal or 
animals are kept4  7#c7 ,! vet]9>ian is 
readily available = foll[-up evaluation 
or has arrang$ = vet]9>y em]g5cy cov]age
 & cont9u+ c>e & treatm5t4  7#d7 ,!     
vet]9>ian provides ov]sight ( treatm5t1 
compliance1 & outcome4  7#e7 ,pati5t    
records are ma9ta9$4