,,ii  #aai? ,,congress  #b;d ,session   
,s4 #dhge  ,,9 ,,! ,,s5ate ,,( ,,!      
,,unit$ ,,/ates  ,june #bc1 #bjbf,mr4   
,b5net 7= himself1 ,mr4 ,"y1 ,mrs4      
,gillibr&1 ,mr4 ,r\nds1 & ,mr4          
,hick5loop]7 introduc$ ! foll[+ bill2   
:i* 0 read twice & ref]r$ to !          
,committee on ,heal?1 ,education1       
,labor1 & ,p5sions  ,a ,,bill  ,to am5d 
! ,public ,heal? ,s]vice ,act to e/abli%
 a program to develop innovative        
antimicrobial drugs t>get+ ! mo/ *all5g+
 pa?og5s & mo/ ?reat5+ infections1 & =  
o!r purposes4  #a4 ,%ort title ,?is ,act
 may be cit$ z ! ,pione]+ ,antimicrobial
 ,subscriptions ,to ,end ,upsurg+       
,resi/ance ,act ( #bjbf or ! ,,pa/eur   
,act ( #bjbf4  #b4 ,purpose ,! purpose (
 ?is ,act is to ensure ! availability ( 
antimicrobials to-- 7#a7 /imulate a new 
age ( rese>*1 developm5t1 & m>ket access
 to lifesav+ m$ic9es2  7#b7 ensure !    
appropriate use ( lifesav+ m$ic9es2     
7#c7 ma9ta9 ! highe/ m$ical c>e /&>ds = 
,am]ican pati5ts2  7#d7 promote national

 heal? sy/em prep>$ness2 &  7#e7 def5d !
 ,unit$ ,/ates & its milit>y4  #c4      
,develop+ antimicrobial innovations     
,title ,,iii ( ! ,public ,heal? ,s]vice 
,act 7#db ,u4,s4,c4 #bda et seq47 is    
am5d$ by add+ at ! end ! foll[+3  ,x    
,u4,s4 ,,novel ,,antimicrobial ,,supply 
,,contracts  #cii,,pp4 ,contract        
application1 aw>d1 & implem5tation  7a7 
,9 g5]al ,! ,secret>y may ent] into     
contracts ) sponsors ( eligible         
antimicrobials = ! purpose ( ensur+ !   
availability ( su* eligible             
antimicrobials4  7b7 ,eligible          
antimicrobial ,to be eligible = a       
contract "u ?is section1 an             
antimicrobial drug %all-- 7#a7 treat a  
pa?og5-- 7,a7 includ$ z an urg5t or     
s]i\s ?reat 9 ! mo/ rec5t ,antibiotic   
,resi/ance ,?reats 9 ! ,unit$ ,/ates    
report publi%$ by ! ,c5t]s = ,disease   
,control & ,prev5tion2 or  7,b7 t !     
,secret>y has det]m9$ appropriate 9     
consultation ) ! ,advisory ,gr\p        
e/abli%$ "u section #cii,,pp-#a2 &  7#b7

 address an unmet m$ical ne$4  7c7      
,applications  7#a7 ,submission ,to be  
eligible to ent] into a contract "u ?is 
section1 a sponsor ( an eligible        
antimicrobial %all submit to ! ,secret>y
 an application n lat] ?an #b ye>s aft] 
! date on :i* ! eligible antimicrobial  
is-- 7,a7 approv$ "u section #eje7;c7 ( 
! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 
7includ+ 9 accordance ) section #ejf7;h7
 ( su* ,act72 or  7,b7 lic5s$ "u section
 #cea7;a7 ( ?is ,act4  7#b7 ,cont5ts ,an
 application submitt$ "u p>agraph 7#a7 )
 respect to an eligible antimicrobial-- 
7,a7 %all include-- 7i7 appropriate     
in=mation to det]m9e ! score ( !        
eligible antimicrobial 9 accordance ) ! 
me?odology e/abli%$ "u subsection 7d72 &
  7ii7 su* o!r in=mation z ! ,secret>y  
det]m9es appropriate2 &  7,b7 is n      
requir$ to include in=mation relat+ to  
pric+ or rese>* & developm5t co/s ( !   
eligible antimicrobial4  7#c7 ,review ,n
 lat] ?an #ij days aft] ! date on :i* ! 
,secret>y receives an application "u ?is

 subsection ) respect to an eligible    
antimicrobial 7includ+ a revis$         
application "u p>agraph 7#d771 !        
,secret>y %all-- 7,a7 review !          
application2  7,b7 if ! eligible        
antimicrobial's score is bel[ ! m9imum  
scor+ ?re%old describ$ 9 subsection     
7d77#a77;,b71 d5y ! application2 &  7,c7
 if ! eligible antimicrobial's score    
meets or exce$s su* m9imum scor+        
?re%old1 approve ! application &        
calculate annual paym5ts = ! contract "u
 subsection 7f74  7#d7 ,revis$          
applications ,beg9n+ #a ye> aft] ! d5ial
 ( an application ) respect to an       
eligible antimicrobial "u p>agraph 7#c71
 & n m frequ5tly ?an once e #b ye>s     
!reaft]1 ! sponsor ( ! eligible         
antimicrobial may submit to ! ,secret>y 
a revis$ application = ! eligible       
antimicrobial ) additional in=mation t  
may mat]ially affect ! eligible         
antimicrobial's score "u subsection 7d74
  7d7 ,scor+  7#a7 ,9 g5]al ,n lat] ?an 
#bgj days aft] ! date ( enactm5t ( ?is  

"p1 ! ,secret>y1 9 consultation ) !     
,advisory ,gr\p e/abli%$ "u section     
#cii,,pp-#a1 ! ,assi/ant ,secret>y =    
,prep>$ness & ,response1 ! ,director ( !
 ,biom$ical ,advanc$ ,rese>* &          
,developm5t ,au?ority1 & ! ,commission] 
( ,food & ,drugs1 %all promulgate       
regulations1 aft] ! consid]ation (      
comm5ts receiv$ 9 response to a public  
reque/ = in=mation & a public he>+1     
e/abli%+-- 7,a7 a quantitative scor+    
me?odology = eligible antimicrobials =  
:i* applications are submitt$ "u ?is    
section2 &  7,b7 a m9imum scor+ ?re%old 
t ! score ( an eligible antimicrobial "u
 p>agraph 7#b7 mu/ meet or exce$ 9 ord] 
= ! sponsor ( su* eligible antimicrobial
 to ent] into a contract "u ?is section4
  7#b7 ,me?odology ,an eligible         
antimicrobial %all receive a score1     
calculat$ by po9ts aw>d$ bas$ on crit]ia
 develop$ 9 consultation ) ! ,advisory  
,gr\p e/abli%$ "u section #cii,,pp-#a )9
 ! foll[+ ?ree categories1 ) a weight+  
assign$ to ea* crit]ion e/abli%$ "u su* 

categories & a great] numb] ( po9ts     
result+ 9 a high] score3 7,a7 ,category 
i ,! eligible antimicrobial's major     
contributions to pati5t c>e1 includ+--  
7i7 improv+ cl9ical outcomes = pati5ts )
 multi-drug-resi/ant infections2  7ii7  
improv$ dose frequ5cy2  7iii7 r$uc$     
toxicity2  7iv7 r$uctions 9 adv]se      
ev5ts2 &  7v7 b5efits f ! eligible      
antimicrobial's r\te ( adm9i/ration1    
especially ?r\gh oral adm9i/ration or m 
?an "o adm9i/ration me?od4  7,b7        
,category ii ,! innovative *>act]i/ics (
 ! eligible antimicrobial1 includ+-- 7i7
 be+ a fir/-approv$ antimicrobial drug t
 has ! pot5tial to address1 or has !    
evid5ce ( address+1 unmet m$ical ne$s = 
! treatm5t ( a s]i\s or life-?reat5+    
infection1 or1 to a less] ext5t1 second 
& ?ird drugs t treat su* infection2     
7ii7 conta9+ no active moiety 7z def9$ 9
 section #cad4c ( title #ba1 ,code (    
,f$]al ,regulations 7or any successor   
regulations77 t has be5 approv$ 9 any   
o!r application "u section #eje7;b7 ( ! 

,f$]al ,food1 ,drug1 & ,cosmetic ,act & 
conta9+ no active +r$i5t lic5s$ 9 any   
o!r biological product lic5se           
application "u section #cea7;a7 ( ?is   
,act2  7iii7 be+ a memb] ( a new class (
 drugs ) a novel t>get or novel mode (  
action t are di/9ctly diff]5t f ! t>get 
or mode ( any antimicrobial drug approv$
 "u su* section #eje7;b7 or lic5s$ "u   
su* section #cea7;a72 &  7iv7 address+ a
 multi-drug resi/ant infection ?r\gh a  
novel *emical scaffold or mode ( action4
  7,c7 ,category iii ,! b5efit ( !      
eligible antimicrobial to heal? sy/ems &
 public heal?1 includ+-- 7i7 n be+      
affect$ by cross-resi/ance to "o or m   
antimicrobials approv$ "u su* section   
#eje7;b7 or lic5s$ "u su* section       
#cea7;a72  7ii7 manufactur+ capabilities
 )9 ! ,unit$ ,/ates2  7iii7 improv$     
product /ability & /orage2  7iv7        
increas$ activity aga9/ resi/ance       
me*anisms2 &  7v7 r$uction ( ! economic 
or population burd5 ( antimicrobial     
resi/ance 9 ! ,unit$ ,/ates4  7e7       

,contract requirem5ts ,z a condition (  
ent]+ into a contract "u ?is section )  
respect to an eligible antimicrobial1 ! 
sponsor ( ! eligible antimicrobial      
%all-- 7#a7 beg9n+ on ! date t is #cj   
days aft] ! sponsor receives its fir/   
paym5t "u ! contract & = ! rema9d] ( !  
contract t]m1 ensure-- 7,a7 ! comm]cial 
availability ( ! eligible antimicrobial 
9 ! ,unit$ ,/ates2 &  7,b7 suffici5t    
supply ( ! eligible antimicrobial =     
antimicrobial susceptibility te/ device 
manufactur]s2  7#b7 id5tify1 track1 &   
publicly report drug resi/ance data &   
tr5ds us+ available data relat$ to !    
eligible antimicrobial1 includ+ ! use ( 
data collect$ by ! ,secret>y "u section 
#cii,,pp-#b7;c72  7#c7 develop &        
implem5t education & communications     
/rategies = heal? c>e pr(essionals &    
pati5ts conc]n+ ! appropriate use ( !   
eligible antimicrobial1 su* z-- 7,a7    
in=mation f label+ approv$ by ! ,food & 
,drug ,adm9i/ration2 &  7,b7            
communications = individuals ) limit$   

,engli% pr(ici5cy & individuals )       
disabilities2  7#d7 submit to !         
,secret>y a plan reg>d+ ! appropriate   
use ( ! eligible antimicrobial1 includ+ 
be/ practices = antimicrobial /ew>d%ip &
 a g5]al description ( h[ ! product w be
 m>ket$4 ,! appropriate use plan may    
include a plan to collect data on !     
impact ( diagno/ics1 antimicrobial      
/ew>d%ip programs1 & o!r appropriate use
 ef=ts on pati5t outcomes & heal?-c>e   
co/s2  7#e7 ^u ! reque/ ( ! ,secret>y1  
submit to ! ,secret>y a plan = regi/]+ !
 eligible antimicrobial 9 c\ntries o!r  
?an ! ,unit$ ,/ates :]e an unmet m$ical 
ne$ exi/s2  7#f7 und]take ef=ts to      
ensure a reliable drug supply *a91      
includ+1 9 ! ev5t ( ! ,food & ,drug     
,adm9i/ration det]m9+ t a %ortage exi/s 
= ! eligible antimicrobial1 n lat] ?an  
#cj days aft] su* det]m9ation submitt+  
to ! ,secret>y a plan to address su*    
%ortage2  7#g7 beg9n+ on ! date t is #cj
 days aft] ! sponsor receives its fir/  
paym5t "u ! contract & = ! rema9d] ( !  

contract t]m1 manufacture ! eligible    
antimicrobial drug at a volume t        
reasonably ensures ! availability (     
suffici5t quantities ( ! drug to meet ! 
ne$s ( individuals ) ! disease or       
condition = :i* ! eligible antimicrobial
 is approv$ 9 ! ,unit$ ,/ates2  7#h7    
abide by manufactur+ & environm5tal be/ 
practices = ! control ( dis*>ge (       
antimicrobial active ph>maceutical      
+r$i5ts & o!r antimicrobial ag5ts or    
products1 includ+ ! antibiotic          
manufactur+ /&>d develop$ by ! ,,amr    
,indu/ry ,alliance 7z describ$ 9 !      
report titl$ ,m9imiz+ risk ( develop+   
antibiotic resi/ance & aquatic          
ecotoxicity 9 ! environm5t result+ f !  
manufactur+ ( human antibiotics publi%$ 
9 ,may #bjbe7 or seek+ a su/a9ability   
c]tification f ,,bsi ,/&>ds ,limit$2 &  
7#i7 abide by su* o!r t]ms z ! ,secret>y
 may require "u ! contract4  7f7 ,annual
 paym5ts  7#a7 ,9 g5]al ,pursuant to a  
contract ent]$ into "u ?is section1 !   
,secret>y %all make annual paym5ts to ! 

sponsor ( an eligible antimicrobial = ! 
duration ( ! contract t]m4 ,su* paym5ts 
%all beg9 n lat] ?an #ahj days aft] !   
date on :i* ! ,secret>y approves !      
contract4  7#b7 ,calculation sy/em ,!   
,secret>y1 9 consultation ) !           
,adm9i/rator ( ! ,c5t]s = ,m$ic>e       
,m$icaid ,s]vices1 %all promulgate      
regulations e/abli%+ a sy/em = !        
calculation ( ! annual paym5ts describ$ 
9 p>agraph 7#a74 ,su* sy/em %all adh]e  
to ! foll[+3 7,a7 ,m9imum & maximum     
am\nt ,an annual paym5t may n be less   
?an #ge1jjj1jjj or m ?an #cjj1jjj1jjj1  
adju/$ on an annual basis 9 accordance )
 ! consum] price index = all urban      
consum]s 7all items2 ,unit$ ,/ates city 
av]age74  7,b7 ,adju/m5t = net rev5ue ,!
 annual paym5t %all be adju/$ d[nw>d by 
! am\nt ( net rev5ue f sales 9 ! ,unit$ 
,/ates ( ! eligible antimicrobial dur+ !
 previ\s #ab-mon? p]iod1 includ+ any    
legally m&at$ or volunt>y disc\nts &    
rebates provid$ by ! sponsor ( !        
eligible antimicrobial1 su* z volume    

disc\nts1 prompt pay disc\nts1 ca%      
disc\nts1 free goods t are cont+5t on   
any pur*ase requirem5t1 *>gebacks1 &    
rebates4  7#c7 ,disclosure ( in=mation  
,! ,secret>y may require ! sponsor ( an 
eligible antimicrobial to disclose to ! 
,secret>y su* in=mation z ! ,secret>y   
requires to calculate an annual paym5t  
"u ?is subsection4 ,not)/&+ any o!r     
provision ( law1 su* in=mation %all be  
kept confid5tial & may n be-- 7,a7      
disclos$ by ! ,secret>y to any entity1  
includ+ o!r gov]nm5tal or private       
p>ties1 9 a =m t reveals ! id5tity ( a  
specific manufactur] or ! prices *>g$ = 
drugs by su* manufactur]2 or  7,b7 us$  
by ! ,secret>y = any purpose o!r ?an    
calculat+ ! annual paym5ts "u ?is       
subsection4  7#d7 ,t]m9ation ( paym5ts  
,! ,secret>y may cease annual paym5ts   
pursuant to a contract ent]$ into "u ?is
 section if ! ,secret>y det]m9es t !    
sponsor ( ! eligible antimicrobial      
subject to su* contract-- 7,a7 p]man5tly
 )draws ! eligible antimicrobial f !    

m>ket 9 ! ,unit$ ,/ates2  7,b7 mat]ially
 fails to meet "o or m ( ! requirem5ts  
describ$ 9 subsection 7e7 aft] notice by
 ! ,secret>y & an opportunity to        
correct2 or  7,c7 does n conduct ) due  
dilig5ce a po/m>ket /udy requir$ to be  
complet$ by ! ,food & ,drug             
,adm9i/ration dur+ ! t]m ( ! contract4  
7#e7 ,rule ( con/ruction ,no?+ 9 ?is    
subsection %all be con/ru$ z au?oriz+ ! 
,secret>y-- 7,a7 to disclose any        
in=mation t is a trade secret or        
confid5tial in=mation subject to section
 #eeb7;b77#d7 ( title #e1 ,unit$ ,/ates 
,code1 or section #aije ( title #ah1    
,unit$ ,/ates ,code2 or  7,b7 to use    
evid5ce f comp>ative cl9ical            
effectiv5ess rese>* 9 a mann] t treats  
ext5d+ ! life ( an eld]ly1 disabl$1 or  
t]m9ally ill individual z ( l[] value   
?an ext5d+ ! life ( an individual :o is 
y\ng]1 nondisabl$1 or n t]m9ally ill = !
 purposes ( calculat+ annual paym5ts "u 
?is subsection1 includ+ 9 su* a way t   
w\ld limit pati5t access4  7g7 ,contract

 t]m  7#a7 ,l5g? ( t]m ,! t]m ( a       
contract ent]$ into "u ?is section %all 
end on ! e>li] (-- 7,a7 ! date t is #aj 
ye>s aft] ! date on :i* ! contract is   
approv$2 &  7,b7 ! date on :i* !        
,secret>y det]m9es at lea/ "o drug or   
biological product is-- 7i7 approv$ or  
lic5s$ 7z applicable7-- 7,i7 "u section 
#eje7;j7 ( ! ,f$]al ,food1 ,drug1 &     
,cosmetic ,act1 us+ ! contract          
antimicrobial z ! li/$ drug2 or  7,,ii7 
"u section #cea7k7 ( ! ,public ,heal?   
,s]vice ,act1 us+ ! contract            
antimicrobial z ! ref]5ce product2 &    
7ii7 m>ket$ pursuant to su* approval or 
lic5sure4  7#b7 ,effect ,a contract %all
 rema9 9 effect = ! t]m describ$ 9      
p>agraph 7#a7 ev5 if ! pa?og5 treat$ by 
! eligible antimicrobial is lat] remov$ 
f ! ,antibiotic ,resi/ance ,?reats 9 !  
,unit$ ,/ates report describ$ 9         
subsection 7b77#a77;,a74  7h7 ,o!r      
gov]nm5t p>ticipation ,! ,secret>y %all 
make ef=ts to increase ! p>ticipation ( 
o!r gov]nm5tal bodies 9 (f]+ f9ancial   

inc5tives to create comm]cial access to 
new & novel antimicrobials t are simil> 
to ! contracts "u ?is section4  7i7     
,au?ority ve/$ 9 ! secret>y ,! au?ority 
ve/$ 9 ! ,secret>y by ?is section to    
ent] into contracts may be p]=m$ )\t    
reg>d to su* provisions ( law or        
regulations relat+ to ! mak+1 p]=mance1 
am5dm5t1 or modification ( contracts ( !
 ,unit$ ,/ates1 z ! ,secret>y may       
det]m9e to be inconsi/5t ) ! fur!rance (
 ! purposes ( ?is "p4  #cii,,pp-#a4     
,critical ne$ antimicrobial advisory    
gr\p  7a7 ,9 g5]al ,n lat] ?an #fj days 
aft] ! date ( enactm5t ( ?is "p1 !      
,secret>y %all e/abli% a ,critical ,ne$ 
,antimicrobial ,advisory ,gr\p 7ref]r$  
to 9 ?is "p z ! ,advisory ,gr\p7 &      
appo9t its memb]s4  7b7 ,memb]s ,!      
,advisory ,gr\p %all be compos$ ( #ae   
memb]s1 to be appo9t$ by ! ,secret>y z  
foll[s3 7#a7 #d individuals :o are      
physicians bo>d-c]tifi$ 9 infecti\s     
diseases4  7#b7 #d individuals :o are   
exp]ts ) demon/rat$ exp]tise 9          

antimicrobial resi/ance1 heal?          
economics1 or rese>* & developm5t or    
comm]cialization ( antimicrobial drugs4 
7#c7 #d individuals to s]ve z pati5t    
advocates1 :o are well v]s$ 9           
antimicrobial treatm5t or resi/ance1    
ei!r z pati5ts !mselves or z c>etak]s4  
7#d7 #c additional individuals :o meet !
 qualifications specifi$ 9 p>agraph     
7#a71 7#b71 or 7#c74  7c7 ,*air ,9      
addition to ! memb]s appo9t$ "u         
subsection 7b71 ! ,secret>y %all appo9t 
#a individual to s]ve z a non-vot+ ,*air
 ( ! ,advisory ,gr\p4 ,su* individual   
%all meet ! qualifications specifi$ 9   
p>agraph 7#a71 7#b71 or 7#c7 (          
subsection 7b74  7d7 ,conflicts ( int]e/
 ,9 appo9t+ memb]s "u subsection 7b7 & a
 ,*air "u subsection 7c71 ! ,secret>y   
%all ensure t no memb] 7includ+ ! ,*air7
 receives dur+ ! individual's t]m (     
s]vice ) ! ,advisory ,gr\p comp5sation 9
 any mann] f a comm]cial or =-pr(it     
entity t develops or int5ds to develop  
antimicrobial drugs4 ,9 implem5t+ !     

requirem5ts ( ?is "p1 ! ,secret>y %all  
prohibit ,advisory ,gr\p memb]s 7includ+
 ! ,*air7 f p>ticipat+ 9 any p>ticul>   
,advisory ,gr\p matt] t w h a direct &  
pr$ictable effect on _! f9ancial        
int]e/s4  7e7 ,applicability ( ,,faca   
7#a7 ,9 g5]al ,except z o!rwise provid$ 
9 ?is section1 *apt] #aj ( title #e1    
,unit$ ,/ates ,code 7commonly ref]r$ to 
z ! ,f$]al ,advisory ,committee ,act7   
%all apply to ! ,advisory ,gr\p4  7#b7  
,t]m9ation ,section #ajac ( su* title   
7relat+ to ! t]m9ation ( advisory       
committees7 %all n apply to ! ,advisory 
,gr\p4  #cii,,pp-#b4 ,enc\rag+          
appropriate use ( antimicrobials &      
combat+ resi/ance  7a7 ,heal? facility  
grant program  7#a7 ,9 g5]al ,n lat] ?an
 #a ye> aft] ! date ( enactm5t ( ?is "p1
 ! ,secret>y1 act+ ?r\gh ! ,director ( !
 ,c5t]s = ,disease ,control & ,prev5tion
 79 ?is subsection ref]r$ to z !        
,secret>y71 %all e/abli% a grant program
 to support hospital1 skill$ nurs+      
facility1 & o!r heal? c>e facility      

ef=ts-- 7,a7 to judici\sly use          
antimicrobial drugs1 su* z by e/abli%+  
or implem5t+ appropriate use programs1  
includ+ infecti\s disease teleheal?     
programs1 us+ appropriate diagno/ic     
tools1 p>tn]+ ) academic hospitals1     
increas+ heal? c>e-associat$ infection  
report+ & prev5tion ef=ts1 & monitor+   
antimicrobial resi/ance2 &  7,b7 to     
p>ticipate 9 ! ,national ,heal?c>e      
,safety ,network ,antimicrobial ,use &  
,resi/ance ,module or ! ,em]g+          
,infections ,program                    
,heal?c>e-,associat$ ,infections        
,community ,int]face activity ( ! ,c5t]s
 = ,disease ,control & ,prev5tion1 z    
specifi$ by ! ,secret>y1 relat+ to      
antimicrobial drugs4  7#b7              
,prioritization ,9 aw>d+ grants "u      
p>agraph 7#a71 ! ,secret>y %all         
prioritize heal? c>e facilities )\t an  
exi/+ program to judici\sly use         
antimicrobial drugs1 subsection 7d7     
hospitals 7z def9$ 9 section            
#ahhf7;d77#a77;,b7 ( ! ,social ,security

 ,act7 t are locat$ 9 rural areas 7z    
def9$ 9 section #ahhf7;d77#b77;,d7 ( su*
 ,act71 critical access hospitals 7z    
def9$ 9 section #ahfa7mm77#a7 ( su*     
,act71 hospitals s]v+ ,tribal           
populations1 & safety-net hospitals4    
7#c7 ,/&>ds = use ( grant funds ,9      
implem5t+ or exp&+ an antibiotic        
/ew>d%ip program1 an entity receiv+ a   
grant "u p>agraph 7#a7 %all adh]e to    
nationally recogniz$ guidel9es & be/    
practices1 includ+ adequate /aff+1 =    
improv+ antibiotic use4  7b7            
,antimicrobial /ew>d%ip pilot program = 
outpati5t facilities  7#a7              
,antimicrobial /ew>d%ip pilot program = 
outpati5t facilities ,n lat] ?an #b ye>s
 aft] ! date ( enactm5t ( ?is "p1 !     
,secret>y1 9 consultation ) ! ,director 
( ! ,c5t]s = ,disease ,control &        
,prev5tion & ! ,adm9i/rator ( ! ,c5t]s =
 ,m$ic>e  ,m$icaid ,s]vices 79 ?is      
subsection ref]r$ to z ! ,secret>y71    
%all e/abli% a pilot program to make    
grants to entities to implem5t or exp&  

antibiotic /ew>d%ip programs 9 outpati5t
 facilities4  7#b7 ,implem5tation ,9    
develop+ ! pilot program1 ! ,secret>y   
%all consult ) pr(essional societies )  
exp]tise 9 antibiotic /ew>d%ip4  7#c7   
,eligible entities ,to be eligible to   
receive a grant "u p>agraph 7#a71 an    
entity %all be-- 7,a7 a physician2  7,b7
 a hospital outpati5t dep>tm5t2  7,c7 an
 urg5t c>e sett+ describ$ 9 p>agraph    
7#e77;,a72 or  7,d7 a retail cl9ic      
describ$ 9 p>agraph 7#e77;,b74  7#d7    
,/&>ds = use ( grant funds ,9 implem5t+ 
or exp&+ an antibiotic /ew>d%ip program 
?r\gh a grant "u ?is subsection1 an     
entity %all adh]e to nationally         
recogniz$ guidel9es & be/ practices1    
includ+ adequate /aff+1 = improv+       
antibiotic use4  7#e7 ,prioritization ,9
 aw>d+ grants "u p>agraph 7#a71 !       
,secret>y %all prioritize-- 7,a7 urg5t  
c>e sett+s1 su* z facilities t use      
,place ( ,s]vice ,code #bj = urg5t c>e  
develop$ by ! ,c5t]s = ,m$ic>e  ,m$icaid
 ,s]vices 7or any successor code72 &    

7,b7 retail cl9ics1 mean+ facilities t  
are co-locat$ ) a ph>macy or o!r retail 
comm]cial e/abli%m5t1 su* z ^? t use    
,place ( ,s]vice ,code #ag = walk-9     
retail heal? cl9ics develop$ by ! ,c5t]s
 = ,m$ic>e  ,m$icaid ,s]vices 7or any   
successor code74  7#f7 ,report ,n lat]  
?an #e ye>s aft] ! date ( enactm5t ( ?is
 "p1 ! ,secret>y %all submit to         
,congress a report on ! impacts ( !     
pilot program1 includ+ recomm5dations = 
exp&+ antimicrobial /ew>d%ip to         
additional outpati5t sett+s4  7c7       
,surveillance & report+ ( antimicrobial 
use & resi/ance  7#a7 ,9 g5]al ,!       
,secret>y1 act+ ?r\gh ! ,director ( !   
,c5t]s = ,disease ,control & ,prev5tion1
 %all use ! ,national ,heal?c>e ,safety 
,network & o!r appropriate surveillance 
sy/ems to collect data & assess tr5ds 9 
antimicrobial resi/ance & antibiotic &  
antifungal use1 su* z-- 7,a7 appropriate
 conditions & measures causally relat$  
to antimicrobial resi/ance1 includ+     
types ( infections1 ! s\rce or body     

sites ( infections1 ! demographic       
in=mation ( pati5ts ) infections1       
infection onset 9 a community or        
hospital sett+1 increas$ l5g?s (        
hospital /ay1 increas$ co/s1 & rates (  
mortality2 &  7,b7 *anges 9 bact]ial &  
fungal resi/ance to antimicrobial drugs1
 includ+ *anges 9 p]c5t resi/ance1      
preval5ce ( antimicrobial-resi/ant      
infections1 rates ( mortality1 & o!r su*
 *anges4  7#b7 ,antimicrobial use data  
,! ,secret>y1 act+ ?r\gh ! ,director ( !
 ,c5t]s = ,disease ,control &           
,prev5tion1 %all obta9 reliable &       
comp>able human antibiotic & antifungal 
drug consumption data 7includ+1 z       
available & appropriate1 volume         
antimicrobial di/ribution data &        
antibiotic & antifungal use data1       
includ+ prescription data7 by ,/ate or  
metropolitan areas4 ,to accompli% ?is1 !
 ,secret>y may "w )1 z appropriate1     
,f$]al dep>tm5ts & ag5cies 7includ+ !   
,dep>tm5t ( ,vet]ans ,affairs1 !        
,dep>tm5t ( ,def5se1 ! ,dep>tm5t (      

,homel& ,security1 ! ,bureau ( ,prisons1
 ! ,indian ,heal? ,s]vice1 & ! ,c5t]s = 
,m$ic>e  ,m$icaid ,s]vices71 private    
v5dors1 heal? c>e organizations1 ph>macy
 b5efit manag]s1 & o!r entities4  7#c7  
,antimicrobial resi/ance tr5d data ,!   
,secret>y1 act+ ?r\gh ! ,director ( !   
,c5t]s = ,disease ,control & ,prev5tion1
 %all int5sify & exp& ef=ts to collect  
antimicrobial resi/ance data & enc\rage 
adoption ( ! ,antimicrobial ,use &      
,resi/ance ,module or o!r appropriate   
module )9 ! ,national ,heal?c>e ,safety 
,network & o!r appropriate surveillance 
sy/ems among all heal? c>e facilities   
across ! cont9uum ( c>e1 includ+1 z     
appropriate1 acute c>e hospitals1       
dialysis facilities1 nurs+ homes1       
ambulatory surgical c5t]s1 & o!r        
ambulatory heal? c>e sett+s 9 :i*       
antimicrobial drugs are r\t9ely         
prescrib$4 ,! ,secret>y %all seek to    
collect su* data f electronic m$ication 
adm9i/ration reports & laboratory sy/ems
 to produce ! reports describ$ 9        

p>agraph 7#e74  7#d7 ,diagno/ics data ,!
 ,secret>y %all collect data on te/s us$
 to diagnose & in=m ! appropriate       
treatm5t ( infections 9 heal? c>e       
sett+s4 ,?is includes data on !         
implem5tation ( diagno/ic /ew>d%ip to   
ensure ! appropriate use ( a diagno/ic  
te/ be=e a treatm5t is prescrib$1 & !   
use ( diagno/ics 9 monitor+ & track+    
infecti\s diseases4 ,! ,secret>y %all   
collect data on ! use ( diagno/ic te/s  
?r\gh ! ,national ,heal?c>e ,safety     
,network 79 ?is p>agraph ref]r$ to z !  
,,nhsn7 ,antimicrobial ,use & ,resi/ance
 ,module or o!r appropriate ,,nhsn      
module4 ,^! ef=ts %all be implem5t$ 9   
collaboration ) ext]nal /akehold]s1     
includ+ infecti\s disease pr(essional   
societies1 pati5t advocacy              
organizations1 heal? c>e sy/ems &       
pr(essionals1 & ! diagno/ics indu/ry4   
7#e7 ,public availability ( data ,beg9n+
 on ! date t is #b ye>s aft] ! date (   
enactm5t ( ?is "p1 ! ,secret>y %all1 = !
 purposes ( improv+ ! monitor+ (        

important tr5ds 9 antimicrobial use &   
resi/ance1 &1 z appropriate1 pati5t     
outcomes 9 relation to antimicrobial    
resi/ance-- 7,a7 make ! data describ$ 9 
p>agraphs 7#a7 ?r\gh 7#d7 publicly      
available ?r\gh reports & web updates   
issu$ on a regul> basis t is n less ?an 
annually2 &  7,b7 exam9e opportunities  
to make su* data available 9 ne> real   
"t4  #cii,,pp-#c4 ,def9itions ,9 ?is "p3
 7#a7 ,antimicrobial drug ,! t]m        
antimicrobial drug-- 7,a7 means-- 7i7 a 
drug t directly inhibits replication (  
or kills bact]ia or fungi1 or acts on ! 
sub/ances produc$ by su* bact]ia or     
fungi1 relevant to ! propos$ indication 
at conc5trations likely to be atta9able 
9 humans to a*ieve ! int5d$ !rapeutic   
effect2 &  7ii7 a biological product t  
acts directly on bact]ia or fungi or on 
! sub/ances produc$ by su* bact]ia or   
fungi2 &  7,b7 does n include-- 7i7 a   
drug t a*ieves ! effect describ$ 9      
subp>agraph 7,a77i7 only at a           
conc5tration t _c reasonably be /udi$ 9 

humans because ( its anticipat$         
toxicity2 or  7ii7 a vacc9e4  7#b7      
,contract ,! t]m contract means a       
transaction o!r ?an a procurem5t        
contract1 grant1 or a coop]ative        
agreem5t4  7#c7 ,contract antimicrobial 
,! t]m contract antimicrobial means an  
antimicrobial drug or biological product
 = :i* a contract "u ?is "p is 9 effect4
  7#d7 ,eligible antimicrobial ,! t]m   
eligible antimicrobial means an         
antimicrobial drug or biological product
 t satisfies ! eligibility crit]ia      
describ$ 9 section #cii,,pp7b74         
#cii,,pp-#d4 ,appropriations  7a7 ,9    
g5]al ,to c>ry out ?is "p1 !re is       
au?oriz$ to be appropriat$1 &           
appropriat$1 to ! ,secret>y1 out (      
am\nts 9 ! ,treasury n o!rwise          
appropriat$1 #f1jjj1jjj1jjj = fiscal ye>
 #bjbf1 to rema9 available until exp5d$4
  7b7 ,allocation ,! ,secret>y may use n
 m ?an #f4e p]c5t ( ! am\nts appropriat$
 "u subsection 7a7 to c>ry out section  
#cii,,pp-#b4  7c7 ,em]g5cy designation  

7#a7 ,9 g5]al ,! am\nts provid$ by ?is  
section are designat$ z an em]g5cy      
requirem5t pursuant to section #d7;g7 ( 
! ,/atutory ,pay-,z-,y-,g ,act ( #bjaj4 
7#b7 ,designation 9 s5ate ,9 ! ,s5ate1  
?is section is designat$ z an em]g5cy   
requirem5t pursuant to section #daab7;a7
 ( ,h4 ,con4 ,res4 #ga 7#aae?           
,congress71 ! concurr5t resolution on ! 
budget = fiscal ye> #bjah4  4