,i  #aacth ,,congress  #ast ,session    
,h4 ,r4 #hbj  ,,in ,,the ,,house ,,of   
,,representatives  ,february #bf1 #bjac 
,mr4 ,waxman 7for himself and ,ms4      
,slaughter7 introduced the following    
bill2 which was referred to the         
,committee on ,energy and ,commerce  ,a 
,,bill  ,to amend the ,federal ,food1   
,drug1 and ,cosmetic ,act to enhance the
 reporting requirements pertaining to   
use of antimicrobial drugs in food      
animals4  #a4 ,short title ,this ,act   
may be cited as the ,delivering         
,antimicrobial ,transparency in ,animals
 ,act of #bjac4  #b4 ,findings ,the     
,congress finds the following3  7#a7    
,antimicrobials are of critical         
importance to public health and to the  
,american economy4  7#b7 ,use of        
antimicrobials1 whether in human        
medicine or in agriculture1 contributes 
to the development and spread of        
antimicrobial resistance4  7#c7 ,data   
from the ,food and ,drug ,administration
 7,,fda7 indicate that approximately #hj

 percent of all antimicrobials sold in  
the ,united ,states1 over #bi1jjj1jjj   
pounds in #bjji1 were sold for use in   
food animals4  7#d7 ,a study published  
in ,september1 #bjab1 in ,proceedings of
 the ,national ,academy of ,sciences of 
the ,united ,states of ,america found   
that even low doses of antimicrobials in
 animal feed for short periods of time  
increased the prevalence of the bacteria
 ,e4 coli and the prevalence and        
diversity of antimicrobial resistance   
genes in bacteria in pigs4  7#e7 ,public
 ,law #aaj-caf1 the ,animal ,drug ,user 
,fee ,amendments of #bjjh1 requires     
producers of drugs used in food animals 
to provide specified information        
annually to the ,,fda on the sales and  
indications for use of such drugs4  7#f7
 ,a ,september #bjaa study by the       
,government ,accountability ,office     
found that the data provided to the     
,,fda under the ,animal ,drug ,user ,fee
 ,amendments ,act of #bjjh lacked       
sufficient details necessary to analyze 

trends in antimicrobial resistance1 such
 as information on actual drug use in   
specific food-producing animal species4 
#c4 ,purpose ,the purpose of this ,act  
is to provide the ,food and ,drug       
,administration and the public with     
better information on the use of        
antimicrobial drugs in animals used for 
food to--  7#a7 enable public health    
officials and scientists to better      
understand and interpret trends and     
variations in rates of microbial        
resistance to such antimicrobial drugs2 
7#b7 improve the understanding of the   
relationship between antimicrobial drug 
use in animals used for food and        
antimicrobial drug resistance in        
microbes in and on animals and humans2  
and  7#c7 identify interventions to     
prevent and control such antimicrobial  
drug resistance4  #d4 ,enhanced         
reporting requirements  7a7 ,reports    
,section #eab7l7 of the ,federal ,food1 
,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4
 #cfj;b7l77 is amended by striking      

paragraph 7#c7 and inserting the        
following3  7#c7 7,a7 ,in the case of   
each new animal drug described in       
paragraph 7#a7 that contains an         
antimicrobial active ingredient1 the    
sponsor of the drug shall submit an     
annual report to the ,secretary on the  
amount of each antimicrobial active     
ingredient in the drug that is sold or  
distributed for use in food-producing   
animals1 including information on any   
distributor-labeled product4  7,b7 ,each
 report under this paragraph shall      
specify the amount of each antimicrobial
 active ingredient--  7i7 by container  
size1 strength1 and dosage form2  7ii7  
by quantities distributed to each ,state
 domestically and by quantities         
exported2 and  7iii7 by dosage form1    
including 7for each dosage form7 the    
known or estimated amounts of the       
antimicrobial active ingredient sold or 
distributed for use in each             
food-producing animal for which the new 
animal drug is approved1 including a    

description of the methods used to      
determine or estimate the amounts4  7#d7
 7,a7 ,subject to subparagraph 7,b71 in 
the case of animal feed in final        
formulation bearing or containing a new 
animal drug for which reporting is      
required under paragraph 7#c71 a live   
poultry dealer1 swine contractor1 or    
feed lot operator who purchases1        
contracts1 or manufactures such feed    
shall submit to the ,secretary an annual
 report that specifies1 by              
food-producing animal for which the new 
animal drug is approved and1 where      
applicable as determined by the         
,secretary1 by production class of such 
animal--  7i7 the amount of each        
antimicrobial active ingredient         
contained per kilogram of each such feed
 sold or distributed for that animal    
and1 where applicable1 production class2
  7ii7 the quantity of such feed sold or
 distributed for that animal and1 where 
applicable1 production class2 and  7iii7
 for each such feed sold or distributed 

under a veterinary feed directive--     
7,i7 the indications for which the feed 
was sold or distributed and the         
quantities of such feed that were sold  
or distributed per each such indication2
  7,,ii7 the number of individuals of   
the food-producing animal and1 where    
applicable1 the production class to     
which the feed was intended2 and        
7,,iii7 the length of time over which   
the feed was intended to be provided to 
the animals and the dose of the active  
antimicrobial ingredient the animals    
were intended to receive4  7,b7 7i7     
,subparagraph 7,a7 does not apply to a  
live poultry dealer1 swine contractor1  
or feed lot operator if the total value 
of the live animals owned1 purchased1   
sold1 contracted for1 or otherwise      
controlled by the dealer1 contractor1 or
 operator1 directly or through          
subsidiaries or affiliates1 per year1   
does not exceed--  7,i7 #aj1jjj1jjj2 or 
7,,ii7 such other sum as the ,secretary 
may specify through regulation4  7ii7   

,the ,secretary may specify through     
regulation alternative reporting        
requirements1 including via pilot       
programs or based on the results of     
pilot programs--  7,i7 to improve the   
accuracy of reports2  7,,ii7 to lessen  
the burden of reporting2  7,,iii7 to    
facilitate the ,secretary's ability to  
provide public summaries of the reports2
 or  7,,iv7 to improve the ,secretary's 
ability to use the reports1 or the      
public's ability to use the summaries   
under paragraph 7#e71 to understand the 
relationship between sales1             
distribution1 and end-use practices with
 respect to feed containing new animal  
drugs described in paragraph 7#a7 and   
antimicrobial resistance trends in      
microbes in animals1 animal food        
products1 and humans4  7#e7 7,a7 ,each  
report under paragraph 7#c7 or 7#d7     
shall--  7i7 be submitted electronically
 not later than ,march #ca each year2   
7ii7 cover the period of the preceding  
calendar year2  7iii7 include separate  

information for each month of such      
calendar year2 and  7iv7 be in such     
format as the ,secretary may require4   
7,b7 ,in specifying a format under      
subparagraph 7,a77iv71 the ,secretary   
shall seek to ensure that such format   
enables the data reported to be         
integrated or otherwise easily          
associated and compared with data from  
other ,federal databases containing data
 on--  7i7 drug sales for human use2 and
  7ii7 rates of antimicrobial resistance
 in bacteria in and on animals1 animal  
food products1 and people4  7,c7 ,the   
,secretary may share information        
reported under paragraph 7#c7 or 7#d7   
with the ,antimicrobial ,resistance     
,task ,force established under section  
#cai;,e of the ,public ,health ,service 
,act4  7,d7 7i7 ,not later than         
,november #cj each year1 the ,secretary 
shall make publicly available summaries 
of the information reported under       
paragraphs 7#c7 and 7#d74  7ii7 ,for    
each summary under clause 7i71 except as

 provided in clause 7iii71 the          
,secretary shall--  7,i7 report data by 
antimicrobial drug class2  7,,ii7 for   
each such antimicrobial drug class1     
specify--  7aa7 the quantity of drugs   
sold or distributed per dosage form2    
7bb7 the percentage of drugs sold or    
distributed with labeled indications    
that fall within each of the following  
categories3 growth promotion1 feed      
efficiency1 or other production         
purposes2 disease prevention2 disease   
control2 and disease treatment2  7cc7   
the quantity of drugs sold or           
distributed per each of the following   
marketing categories3 over-the-counter1 
prescription1 and veterinary feed       
directive2  7dd7 the quantity of drugs  
sold or distributed per ,state of sale  
or distribution2 and  7ee7 the known or 
estimated quantity of drugs sold or     
distributed for each food-producing     
animal and1 where feasible1 production  
class of such animal2 and  7,,iii7 for  
each feed sold or distributed under a   

veterinary food directive for which     
reporting is required under paragraph   
7#d71 include the information reported  
pursuant to subclauses 7,i71 7,,ii71 and
 7,,iii7 of paragraph 7#d77;,a77iii74   
7iii7 ,for any antimicrobial drug class 
with fewer than #c sponsors of approved 
new animal drugs1 instead of reporting  
data under clause 7ii71 the ,secretary  
shall for each such class--  7,i7 report
 data by category of importance of the  
antimicrobial drugs within that class to
 human medicine1 as determined by the   
,secretary2 and  7,,ii7 to the extent   
feasible for each such category1        
specify--  7aa7 the quantity of drugs   
sold or distributed per dosage form2    
7bb7 the percentage of drugs sold or    
distributed with labeled indications    
that fall within each of the following  
categories3 growth promotion1 feed      
efficiency1 or other production         
purposes2 disease prevention2 disease   
control2 and disease treatment2  7cc7   
the quantity of drugs sold or           

distributed per each of the following   
marketing categories3 over-the-counter1 
prescription1 and veterinary feed       
directive2 and  7dd7 the quantity of    
drugs sold or distributed per ,state of 
sale or distribution4  7iv7 ,in carrying
 out this subparagraph1 the ,secretary  
shall report data in a manner consistent
 with protecting both national security 
and confidential business information4  
7,e7 ,in this paragraph1 the terms live 
poultry dealer and swine contractor have
 the meanings given to those terms in   
section #b of the ,packers and          
,stockyards ,act1 #aiba4  4  7b7 ,rule  
of application ,the amendment made by   
this section applies to reports under   
paragraphs 7#c7 and 7#d7 of section     
#eab7l7 of the ,federal ,food1 ,drug1   
and ,cosmetic ,act 7#ba ,u4,s4,c4       
#cfj;b7l77 7as amended by subsection    
7a77 that cover the period of calendar  
year #bjad or any subsequent calendar   
year4 ,the provisions of section        
#eab7l77#c7 of such ,act1 as in effect  

the day before the date of enactment of 
this ,act1 apply to reports that cover  
the period of calendar year #bjac4  #e4 
,enhanced collaboration between the     
,food and ,drug ,administration and the 
,department of ,agriculture ,the        
,secretary of ,health and ,human        
,services1 acting through the           
,commissioner of ,food and ,drugs1 shall
 increase collaboration and coordination
 with the ,secretary of ,agriculture to 
expand and coordinate the collection of 
data on the use of antimicrobial drugs  
in or on cattle1 swine1 chickens1       
turkeys1 and such other food-producing  
animal species as agreed to by the      
,secretary of ,health and ,human        
,services and the ,secretary of         
,agriculture1 including by providing    
information to the ,secretary of        
,agriculture for use by--  7#a7 the     
,animal and ,plant ,health ,inspection  
,service to help inform its collection  
of data through the ,national ,animal   
,health ,monitoring ,system2 and  7#b7  

the ,economic ,research ,service to help
 inform its collection of data through  
the ,agricultural ,resource ,management 
,survey4  #f4 ,action by ,government    
,accountability ,office  7a7            
,publication of final guidance ,not     
later than #ahj days after the date of  
enactment of this ,act1 the ,secretary  
of ,health and ,human ,services shall   
publish a final version of draft        
guidance #bac1 entitled ,new ,animal    
,drugs and ,new ,animal ,drug           
,combination ,products ,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 #bji4  7b7       
,report by ,,gao  7#a7 ,in general ,not 
later than #c years after the           
publication of final guidance pursuant  
to subsection 7a71 the ,comptroller     
,general of the ,united ,states shall   
commence a study to evaluate--  7,a7 the
 voluntary approach used by the ,food   

and ,drug ,administration to eliminate  
injudicious use of antimicrobial drugs  
in food-producing animals2 and  7,b7 the
 effectiveness of the data collection   
activities conducted by the ,food and   
,drug ,administration regarding         
antimicrobial resistance4  7#b7 ,report 
,not later than #a year after commencing
 the study required by paragraph 7#a71  
the ,comptroller ,general of the ,united
 ,states shall submit to the ,committee 
on ,health1 ,education1 ,labor1 and     
,pensions of the ,senate and the        
,committee on ,energy and ,commerce of  
the ,house of ,representatives a report 
that describes the results of such      
study4