,,ii  #aaeth ,,congress  #ast ,session  
,s4 #fbi  ,,in ,,the ,,senate ,,of ,,the
 ,,united ,,states  ,march #ad1         
#bjag,mrs4 ,feinstein 7for herself and  
,ms4 ,collins7 introduced the following 
bill2 which was read twice and referred 
to the ,committee on ,health1           
,education1 ,labor1 and ,pensions  ,a   
,,bill  ,to amend the ,federal ,food1   
,drug1 and ,cosmetic ,act to ensure the 
safety and effectiveness of medically   
important antimicrobials approved for   
use in the prevention1 control1 and     
treatment of animal diseases1 in order  
to minimize the development of          
antibiotic-resistant bacteria4  #a4     
,short title ,this ,act may be cited as 
the ,preventing ,antibiotic ,resistance 
,act of #bjag4  #b4 ,purpose ,the       
purpose of this ,act is to ensure the   
safety and effectiveness of medically   
important antimicrobials approved for   
use in the prevention1 control1 and     
treatment of animal diseases1 in order  
to minimize the development of          

antibiotic-resistant bacteria4  #c4     
,evidence of safety of medically        
important veterinary antimicrobials  7a7
 ,applications pending or submitted     
after enactment ,section #eab7;d77#a7 of
 the ,federal ,food1 ,drug1 and         
,cosmetic ,act 7#ba ,u4,s4,c4           
#cfj;b7d77#a77 is amended--  7#a7 in the
 first sentence--  7,a7 in subparagraph 
7,h71 by striking or at the end2  7,b7  
in subparagraph 7,i71 by inserting or at
 the end2 and  7,c7 by inserting after  
subparagraph 7,i7 the following3  7,j7  
with respect to a medically important   
antimicrobial 7as defined in subsection 
7r771 the applicant has failed to       
demonstrate that a new animal drug      
application for an antimicrobial labeled
 for disease prevention or control meets
 the criteria in subsection             
7r77#b77;,a72  2 and  7#b7 in the second
 sentence1 by striking 7,a7 through 7,i7
 and inserting 7,a7 through 7,j74  7b7  
,ensuring judicious use in animals of   
medically important antimicrobials      

,section #eab of the ,federal ,food1    
,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4
 #cfj;b7 is amended by adding at the end
 the following3  7r7 ,ensuring judicious
 use in animals of medically important  
antimicrobials  7#a7 ,applicability     
,this subsection applies to medically   
important antimicrobials approved for   
use in a food-producing animal--  7,a7  
7i7 for which there is in effect an     
approval of an application or an        
exemption under subsection 7b71 7i71 or 
7j7 of section #eje2 or  7ii7 that is   
otherwise marketed for human use2  7,b7 
for which the ,guidance for ,industry   
entitled1 ,new ,animal ,drugs and ,new  
,animal ,drug ,combination ,products1   
,administered in or on ,medicated ,feed 
or ,drinking ,water of ,food-,producing 
,animals3 ,recommendations for ,drug    
,sponsors for ,voluntarily ,aligning    
,product ,use ,conditions with ,,gfi    
#bji1 published in ,december #bjac      
applies2 and  7,c7 for which the ,food  
and ,drug ,administration has approved a

 label-- 7i7 for disease control or     
prevention at the same or similar dosage
 level as applicable for the approved   
production use described in subparagraph
 7,b72  7ii7 that does not specify an   
explicitly defined duration of therapy2 
or  7iii7 specifying a dosage that is   
not expected to treat a specific        
bacterial pathogen4  7#b7 ,review of    
disease prevention and control approvals
  7,a7 ,in general ,not later than      
,january #a1 #bjai1 the ,secretary shall
 initiate a process of reviewing        
medically important antimicrobials      
described in paragraph 7#a71 in         
accordance with subparagraph 7,b74  7,b7
 ,review of approval  7i7 ,in general   
,if1 not later than ,january #a1 #bjbj1 
a sponsor of an antimicrobial drug      
described in paragraph 7#a7 submits to  
the ,secretary sufficient evidence to   
demonstrating that1 with respect to such
 drug--  7,i7 there is evidence of      
effectiveness in controlling or         
preventing bacterial disease2  7,,ii7 an

 approved use is consistent with        
accepted veterinary practice2  7,,iii7  
an approved use targets a specific      
bacterial pathogen2  7,,iv7 an approved 
use is appropriately targeted to animals
 at risk of developing a specific       
bacterial disease2  7,v7 an approved use
 has an explicitly defined duration of  
therapy2 and  7,,vi7 there is not a     
reasonable probability of risk to the   
public health due to the development of 
antimicrobial resistance1  the          
,secretary1 not later than ,december    
#ca1 #bjbj1 shall issue a revised label 
approval for such antimicrobial drug1 as
 necessary4  7ii7 ,insufficient evidence
 ,if the sponsor of an antimicrobial    
drug described in paragraph 7#a7 does   
not submit sufficient evidence as       
described in clause 7i7 by ,december    
#ca1 #bjbj1 the ,secretary shall        
withdraw approval of any indication     
claims described in paragraph 7#a77;,b7 
for which the sponsor does not submit   
evidence or for which the ,secretary    

determines the evidence submitted is    
insufficient and1 as necessary1 issue a 
revised label approval4  7,c7           
,withdrawal of claims ,on or before     
,january #a1 #bjbj1 the sponsor of a    
drug described in paragraph 7#a7 may    
request the approval of the ,secretary  
to remove any label claim described in  
paragraph 7#a77;,b71 and the ,secretary 
shall approve any such request and1 as  
necessary1 issue a revised label4 ,the  
sponsor shall not be required to submit 
the evidence required under subparagraph
 7,b77i7 with respect to any claim so   
withdrawn4  7#c7 ,exemptions ,in the    
case of a drug that is a medically      
important antimicrobial for which the   
,secretary grants an exemption under    
section #eje7;i71 the withdrawal of     
indication claims in a food-producing   
animal in accordance with paragraph     
7#b77;,b7 shall be effective on the date
 that is #b years after the date on     
which the ,secretary grants the         
exemption1 unless1 not later than #b    

years after the date on which the       
,secretary grants the exemption1 the    
,secretary provides a written           
determination of intent to extend the   
exemption4  7#d7 ,definition  7,a7 ,in  
general ,in this subsection1 the term   
medically important antimicrobial means 
a drug that--  7i7 is intended for use  
in food-producing animals2 and  7ii7 is 
composed wholly or partly of--  7,i7 any
 kind of penicillin1 tetracycline1      
macrolide1 lincosamide1 streptogramin1  
aminoglycoside1 sulfonamide1            
cephalosporin1 or fluoroquinolone1 or   
any drug included in the list pursuant  
to updates under subparagraph 7,b72 or  
7,,ii7 a drug from an antimicrobial     
class that is listed as highly          
important1 critically important1 or     
important in ,appendix ,a of the        
,guidance for ,industry entitled1       
,evaluating the ,safety of              
,antimicrobial ,new ,animal ,drugs with 
,regard to ,their ,microbiological      
,effects on ,bacteria of ,human ,health 

,concern 7or any successor guidance74   
7,b7 ,review and updates ,the ,secretary
 shall conduct periodic reviews of the  
drugs included in the list described in 
subparagraph 7,a77ii77,i71 and add to or
 remove from such list any drugs that   
the ,secretary determines appropriate4  
,a review shall be undertaken at the    
,secretary's discretion1 but not less   
than once every five years4  4  #d4     
,veterinary oversight of use of         
medically important antimicrobials  7a7 
,in general ,a valid                    
veterinarian-client-patient relationship
 should exist to ensure that medically  
important antimicrobials are used in    
food-producing animals in a manner that 
is consistent with professionally       
accepted best practices4  7b7           
,veterinarian-,client-,patient          
relationship ,in this section1 the term 
veterinarian-client-patient relationship
 means a relationship in which all of   
the following criteria are met3  7#a7   
,the veterinarian has assumed the       

responsibility for making medical       
judgments regarding the health of the   
patient and the client has agreed to    
follow the veterinarian's instructions4 
7#b7 ,the veterinarian has sufficient   
knowledge of the patient to initiate at 
least a general or preliminary diagnosis
 of the medical condition of the        
patient4 ,this means that the           
veterinarian is personally acquainted   
with the keeping and care of the patient
 by virtue of--  7,a7 a timely          
examination of the patient by the       
veterinarian2 or  7,b7 medically        
appropriate and timely visits by the    
veterinarian to the premises where the  
animal or animals are kept4  7#c7 ,the  
veterinarian is readily available for   
follow-up evaluation or has arranged for
 veterinary emergency coverage and      
continuing care and treatment4  7#d7    
,the veterinarian provides oversight of 
treatment1 compliance1 and outcome4     
7#e7 ,patient records are maintained4