,,ii  #aae? ,,congress  #a/ ,session    
,s4 #fbi  ,,9 ,,! ,,s5ate ,,( ,,!       
,,unit$ ,,/ates  ,m>* #ad1 #bjag,mrs4   
,fe9/e9 7= h]self & ,ms4 ,coll9s7       
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
 ! prev5tion1 control1 & treatm5t (     
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 ( #bjag4  #b4 ,purpose  
,! purpose ( ?is ,act is to ensure !    
safety & effectiv5ess ( m$ically        
important antimicrobials approv$ = use 9
 ! prev5tion1 control1 & treatm5t (     
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     
7r771 ! applicant has fail$ to          
demon/rate t a new animal drug          
application = an antimicrobial label$ = 
disease prev5tion or control meets !    
crit]ia 9 subsection 7r77#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  7r7
 ,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* !       
,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] #bjac applies2 &    
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 #bjai1 ! ,secret>y %all
 initiate a process ( review+ m$ically  
important antimicrobials describ$ 9     
p>agraph 7#a71 9 accordance )           
subp>agraph 7,b74  7,b7 ,review (       
approval  7i7 ,9 g5]al ,if1 n lat] ?an  
,janu>y #a1 #bjbj1 a sponsor ( an       
antimicrobial drug describ$ 9 p>agraph  
7#a7 submits to ! ,secret>y suffici5t   
evid5ce to 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 t>gets a       
specific bact]ial pa?og52  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 n a reasonable  
probability ( risk to ! public heal? due
 to ! developm5t ( antimicrobial        

resi/ance1  ! ,secret>y1 n lat] ?an     
,decemb] #ca1 #bjbj1 %all issue a revis$
 label approval = su* antimicrobial     
drug1 z necess>y4  7ii7 ,insuffici5t    
evid5ce ,if ! sponsor ( an antimicrobial
 drug describ$ 9 p>agraph 7#a7 does n   
submit suffici5t evid5ce z describ$ 9   
clause 7i7 by ,decemb] #ca1 #bjbj1 !    
,secret>y %all )draw approval ( any     
indication claims describ$ 9 p>agraph   
7#a77;,b7 = :i* ! sponsor does n submit 
evid5ce or = :i* ! ,secret>y det]m9es ! 
evid5ce submitt$ is insuffici5t &1 z    
necess>y1 issue a revis$ label approval4
  7,c7 ,)drawal ( claims ,on or be=e    
,janu>y #a1 #bjbj1 ! 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;,b71 & ! ,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,b77i7 ) respect to any    
claim s )drawn4  7#c7 ,exemptions ,9 !  

case ( a drug t is a m$ically important 
antimicrobial = :i* ! ,secret>y grants  
an exemption "u section #eje7;i71 !     
)drawal ( indication claims 9 a         
food-produc+ animal 9 accordance )      
p>agraph 7#b77;,b7 %all be effective on 
! date t is #b ye>s aft] ! date on :i* !
 ,secret>y grants ! exemption1 unless1 n
 lat] ?an #b ye>s aft] ! date on :i* !  
,secret>y grants ! exemption1 !         
,secret>y provides a writt5 det]m9ation 
( int5t to ext5d ! exemption4  7#d7     
,def9ition  7,a7 ,9 g5]al ,9 ?is        
subsection1 ! t]m m$ically important    
antimicrobial means a drug t--  7i7 is  
int5d$ = use 9 food-produc+ animals2 &  
7ii7 is compos$ :olly or p>tly (--  7,i7
 any k9d ( p5icill91 tetracycl9e1       
macrolide1 l9cosamide1 /reptogram91     
am9oglycoside1 sulfonamide1             
cephalospor91 or fluoroqu9olone1 or any 
drug includ$ 9 ! li/ pursuant to updates
 "u subp>agraph 7,b72 or  7,,ii7 a drug 
f an antimicrobial class t is li/$ z    
highly important1 critically important1 

or important 9 ,app5dix ,a ( ! ,guidance
 = ,indu/ry entitl$1 ,evaluat+ ! ,safety
 ( ,antimicrobial ,new ,animal ,drugs ) 
,reg>d to ,_! ,microbiological ,effects 
on ,bact]ia ( ,human ,heal? ,conc]n 7or 
any successor guidance74  7,b7 ,review &
 updates ,! ,secret>y %all conduct      
p]iodic reviews ( ! drugs includ$ 9 !   
li/ describ$ 9 subp>agraph 7,a77ii77,i71
 & add to or remove f su* li/ any drugs 
t ! ,secret>y det]m9es appropriate4 ,a  
review %all be und]tak5 at ! ,secret>y's
 discretion1 b n less ?an once e five   
ye>s4  4  #d4 ,vet]9>y ov]sight ( use ( 
m$ically important antimicrobials  7a7  
,9 g5]al ,a valid vet]9>ian-cli5t-pati5t
 relation%ip %\ld exi/ to ensure t      
m$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