,i  #aae? ,,congress  #b;d ,session  ,h4
 ,r4 #fbid  ,,9 ,,! ,,h\se ,,(          
,,repres5tatives  ,june #bh1 #bjah,mr4  
,%imkus 7= himself & ,mr4 ,crd5as7      
introduc$ ! foll[+ bill2 :i* 0 ref]r$ to
 ! ,committee on ,en]gy & ,comm]ce  ,a  
,,bill  ,to am5d ! ,f$]al ,food1 ,drug1 
& ,cosmetic ,act to enc\rage !          
developm5t ( priority antimicrobial     
products ?r\gh ! aw>d ( a transf]able   
exclusivity ext5sion p]iod1 & = o!r     
purposes4  #a4 ,%ort title ,?is ,act may
 be cit$ z ! ,re-,valu+ ,anti-,microbial
 ,products ,act ( #bjah or ! ,,revamp   
,act4  #b4 ,exclusivity to enc\rage     
developm5t ( novel !rapies t>get+ s]i\s 
microbial infections ,sub*apt] ,b (     
*apt] ,v ( ! ,f$]al ,food1 ,drug1 &     
,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;aa et
 seq47 is am5d$ by ins]t+ aft] section  
#ebi;,a ! foll[+3  #ecj4 ,exclusivity to
 enc\rage developm5t ( novel !rapies    
t>get+ s]i\s microbial infections  7a7  
,9 g5]al ,if ! ,secret>y approves an    
application pursuant to section #eje7;c7

 ( ?is ,act or section #cea7;a7 ( !     
,public ,heal? ,s]vice ,act = a drug t  
has be5 designat$ z a priority          
antimicrobial product "u subsection 7k71
 ! ,secret>y %all aw>d to ! hold] ( !   
application a #ab-mon? exclusivity      
ext5sion p]iod describ$ 9 subsection 7c7
 = ! sole purpose ( convey+ su*         
ext5sion1 9 :ole or 9 portions1 to o!r  
sponsors or hold]s to be appli$ )       
respect to "o or m o!r drugs--  7#a7 =  
:i* an application is submitt$ "u       
section #eje7;b77#a72  7#b7 = :i* at    
approval1 new *emical entity exclusivity
 is grant$ "u subsection                
7c77#c77;,e77ii7 & 7j77#e77;,f77ii7 (   
section #eje2 &  7#c7 t is designat$ z a
 fa/ track product "u section #ejf7;b74 
7b7 ,notice to ,secret>y ,^u mak+ a     
conveyance "u subsection 7a71 ! hold] ( 
! approv$ application = ! priority      
antimicrobial product involv$ %all      
submit a notice to ! ,secret>y includ+--
  7#a7 ! "n ( ! priority antimicrobial  
product2  7#b7 ! "n ( ! recipi5t drug2 &

  7#c7 ! duration ( ! convey$           
exclusivity ext5sion p]iod4  7c7 ,effect
 ( conveyance  7#a7 ,ext5sion ( o!r     
applicable exclusivity p]iods           
,imm$iately ^u ! ,secret>y's receipt ( a
 notice "u subsection 7b71 ) respect to 
! recipi5t drug1 ! foll[+ exclusivity   
p]iods 7z applicable7 are ea* ext5d$ by 
! convey$ exclusivity ext5sion p]iod3   
7,a7 ,! #d-ye>1 #e-ye>1 #dh-mon?1 &     
#g-ye> p]iods describ$ 9 subsections    
7c77#c77;,e77ii7 & 7j77#e77;,f77ii7 (   
section #eje4  7,b7 ,! #c-ye> p]iods    
describ$ 9 clauses 7iii7 & 7iv7 (       
subsection 7c77#c77;,e7 & clauses 7iii7 
& 7iv7 ( subsection 7j77#e77;,f7 (      
section #eje4  7,c7 ,! #g-ye> p]iod     
describ$ 9 section #ebg4  7#b7 ,drugs   
subject to li/$ pat5ts ,imm$iately ^u ! 
,secret>y's receipt ( a notice "u       
subsection 7b71 ! p]iod dur+ :i* an     
approval ( an application may n be made 
effective by op]ation ( subsection      
7c77#c7 or 7j77#e77;,b7 ( section #eje1 
z applicable1 9 ! case ( a recipi5t drug

 t is ! subject (--  7,a7 a li/$ pat5t =
 :i* a c]tification has be5 submitt$ "u 
subsection 7b77#b77;,a77ii7 or          
7j77#b77;,a77vii77,,ii7 ( section #eje2 
7,b7 a li/$ pat5t = :i* a c]tification  
has be5 submitt$ "u subsection          
7b77#b77;,a77iii7 or                    
7j77#b77;,a77vii77,,iii7 ( section #eje2
 or  7,c7 a li/$ pat5t = :i* a          
c]tification has be5 submitt$ "u        
subsection 7b77#b77;,a77iv7 or          
7j77#b77;,a77vii77,,iv7 ( section #eje  
if 9 ! pat5t infr+em5t litigation       
result+ f ! c]tification ! c\rt det]m9es
 t ! pat5t is valid & w\ld be infr+$1   
%all be ext5d$ aft] ! date ! li/$ pat5t 
expires 7includ+ any pat5t ext5sions7 = 
a p]iod equal to ! convey$ exclusivity  
ext5sion p]iod4  7d7 ,tim+ ( conveyance 
& notice ,! conveyance ( an exclusivity 
ext5sion p]iod pursuant to subsection   
7a7 & ! provision ( notice "u subsection
 7b7 %all be made no lat] ?an--  7#a7 9 
! case ( a priority antimicrobial       
product t is a drug1 ! la/ day ( ! n9?  

ye> ( ! #e-ye> p]iod describ$ 9         
subsections 7c77#c77;,e77ii7 &          
7j77#e77;,f77ii71 z ext5d$1 z           
applicable1 "u section #eje;,e2 &  7#b7 
9 ! case ( a priority antimicrobial     
product t is a biological product1 ! la/
 day ( ! elev5? ye> ( ! exclusivity     
p]iod describ$ 9 section                
#cea7k77#g77;,a7 ( ! ,public ,heal?     
,s]vice ,act applicable ) respect to su*
 product4  7e7 ,p]mitt$ transactions    
,except z provid$ 9 ?is section1 ! hold]
 ( a convey$ exclusivity ext5sion p]iod 
may sell1 ex*ange1 convey1 or hold =    
use1 su* p]iod4  7f7 ,exception ,a p]iod
 ref]r$ to 9 p>agraph 7#a7 or 7#b7 (    
subsection 7c7 %all n be ext5d$ "u su*  
subsection if ! conveyance ( an         
exclusivity ext5sion p]iod pursuant to  
subsection 7a7 or ! provision ( notice  
"u subsection 7b7 is made lat] ?an #d   
ye>s prior to ! expiration ( su* p]iod4 
7g7 ,limitations  7#a7 ,numb] ( aw>ds ,!
 ,secret>y may make n m ?an #aj aw>ds "u
 subsection 7a74  7#b7 ,aw>d = prior    

approv$ application ,a drug is n        
eligible = designation "u ?is section z 
a priority antimicrobial product if an  
application = approval or lic5sure ( su*
 drug 0 approv$ "u section #eje7;b7 or  
lic5s$ "u section #cea7;a7 ( ! ,public  
,heal? ,s]vice ,act be=e ,janu>y #a1    
#bjah4  7#c7 ,drugs int5d$ = cosmetic   
purpose ,a drug is n eligible =         
designation "u ?is section z a priority 
antimicrobial product if ! drug is      
int5d$ to promote hair gr[? or = any o!r
 cosmetic purpose4  7#d7 ,conveyance    
date ,! hold] ( an exclusivity ext5sion 
p]iod aw>d$ "u or convey$ pursuant to   
subsection 7a7 may n convey su* p]iod to
 be appli$ ) respect to a drug unless   
su* drug is or w be fir/ approv$ "u     
section #eje7;c7 on or aft] ,janu>y #a1 
#bjbc4  7h7 ,contribution ^u conveyance 
,z a condition on ! aw>d ( an           
exclusivity ext5sion p]iod to ! hold] ( 
a drug pursuant to subsection 7a71 !    
,secret>y %all require ! hold]1 ^u any  
conveyance ( ! p]iod pursuant to su*    

subsection1 9 :ole or 9 portions1 to    
make a monet>y contribution to !        
,f\ndation = ! ,national ,in/itutes (   
,heal? t--  7#a7 is 9 an am\nt t is     
equal to #e p]c5t ( ! total value ( !   
consid]ation receiv$ by ! hold] z a     
result ( ! conveyance2 &  7#b7 is       
designat$ to be us$ by ! ,f\ndation to  
conduct or support e>ly-/age rese>* on !
 developm5t ( products to treat or      
prev5t a disease attributable to a      
multi-drug resi/ant bact]ial or fungal  
pa?og54  7i7 ,relation to p$iatric      
exclusivity ,any ext5sion ( a p]iod "u  
subsection 7c7 %all be 9 addition to any
 ext5sion ( ! p]iod "u section #eje;,a (
 ?is ,act1 & any ref]5ce to a p]iod 9   
subsection 7c7 is deem$ to be a ref]5ce 
to ! p]iod z ext5d$ "u su* section      
#eje;,a1 if applicable4  7j7 ,critical  
ne$ antimicrobial priorities  7#a7      
,committee on ,develop+ ,critical ,ne$  
,antimicrobials ,n lat] ?an #fj days    
aft] ! date ( enactm5t ( ! ,re-,valu+   
,anti-,microbial ,products ,act ( #bjah1

 ! ,secret>y %all e/abli% a ,committee  
on ,develop+ ,critical ,ne$             
,antimicrobials4  7#b7 ,memb]%ip ,!     
memb]s ( ! ,committee %all include--    
7,a7 "o repres5tative ( ! ,food & ,drug 
,adm9i/ration2  7,b7 "o repres5tative ( 
! ,c5t]s = ,disease ,control &          
,prev5tion2  7,c7 "o repres5tative ( !  
,biom$ical ,advanc$ ,rese>* &           
,developm5t ,au?ority2 &  7,d7 five     
repres5tatives ( ! community ( o!r      
/akehold]s ) rese>*1 comm]cialization1  
cl9ical1 public heal?1 & economic       
exp]tise 9 ! field ( antimicrobial      
resi/ance1 :i* repres5tatives %all      
include at lea/ "o physician ) exp]i5ce 
treat+ infections caus$ by multidrug    
resi/ant organisms4  7#c7 ,duties ,!    
,committee %all-- 7,a7 n lat] ?an #fj   
days aft] all ( ! initial memb]s ( !    
,committee h be5 appo9t$1 develop &     
publi% on ! website ( ! ,(fice ( !      
,assi/ant ,secret>y = ,prep>$ness &     
,response a propos$ li/ ( critical ne$  
antimicrobial priorities consi/+ (      

specific multi-drug resi/ant bact]ial or
 fungal pa?og5s1 :i* li/ %all be        
develop$ tak+ into consid]ation--  7i7  
specific prev5tion or treatm5t (        
bact]ial or fungal infections = :i* !re 
is an unmet m$ical ne$2 &  7ii7         
susceptibility to specific              
microorganisms & treatm5t ne$ =         
multi-drug resi/ant pa?og5s2  7,b7 p]=m 
o!r activities1 z det]m9$ necess>y by ! 
,secret>y1 to support ! designation (   
priority antimicrobial products "u      
subsection 7k7 & ! review & disposition 
( applications = priority antimicrobial 
products "u subsection 7a72 &  7,c7     
develop recomm5dations to ! ,secret>y & 
! ,congress reg>d+ o!r inc5tives ne$$ to
 ensure a robu/ & r5ewable pipel9e (    
antimicrobial drugs1 ) priority giv5 to 
antimicrobial drugs t are fir/ 9 class1 
possess a novel me*anism ( action1 or   
treat a vuln]able population su* z      
*ildr54  7#d7 ,f9alization & updat+ (   
li/ ( critical ne$ antimicrobials       
priorities ,^u receipt f ! ,committee ( 

! initial propos$ li/ ( critical ne$    
antimicrobial priorities or propos$     
updates to su* li/1 ! ,secret>y %all--  
7,a7 provide a p]iod ( public notice &  
comm5t on ! proposal1 includ+ by publi%+
 ! propos$ li/ on ! ,int]net2  7,b7 hold
 public meet+s to elicit input f        
/akehold]s on ! proposal2 &  7,c7 n lat]
 ?an #ahj days aft] ! ,secret>y's       
receipt ( ! proposal1 publi% a f9al     
v]sion ( ! li/4  7#e7 ,subsequ5t updates
 ,! ,secret>y1 9 coord9ation ) !        
,committee1 %all revise1 & publi% 9     
accordance ) p>agraph 7#d71 ! li/ (     
critical ne$ antimicrobial priorities )9
 #cj days ( approval ( a product        
designat$ "u subsection 7k7 or if !     
,secret>y det]m9es x is necess>y1 b 9   
any case no lat] ?an e #b ye>s4  7#f7   
,re/riction on removal f li/ ,no        
critical ne$ antimicrobial priority may 
be remov$ f ! li/ ( critical ne$        
antimicrobial priorities until aft]     
submission ( ! report requir$ by        
subsection 7n77#a74  7k7 ,designation ( 

priority antimicrobial products  7#a7   
,reque/ ,! manufactur] or sponsor ( a   
drug may reque/ t ! ,secret>y designate 
a drug z a priority antimicrobial       
product at any "t be=e or aft]          
submission ( an application = approval  
or lic5sure ( su* drug "u section       
#eje7;b7 ( ?is ,act or section #cea7;a7 
( ! ,public ,heal? ,s]vice ,act1 z      
applicable4  7#b7 ,designation ,n lat]  
?an #fj days aft] ! submission ( a      
reque/ "u p>agraph 7#a71 ! ,secret>y1 9 
coord9ation ) ! ,committee1 %all--  7,a7
  7i7 approve ! reque/ if ! drug subject
 to ! reque/ is int5d$ to treat or      
prev5t a disease attributable to a      
multi-drug resi/ant bact]ial or fungal  
pa?og5 t is li/$ z a critical ne$       
antimicrobial priority pursuant to      
subsection 7j72 or  7ii7 disapprove !   
reque/ if ! drug subject to ! reque/ is 
n int5d$ to treat or prev5t su* a       
disease2 &  7,b7 notify ! reque/or ( su*
 action &1 = any disapproval1 include 9 
su* notification an explanation ( !     

reason = ! disapproval4  7#c7           
,limitation ,a designation "u p>agraph  
7#b7 %all n be )drawn = any reason1     
includ+ modifications to ! li/ (        
critical ne$ antimicrobial priorities1  
unless ! ,secret>y f9ds t ! reque/ = su*
 designation conta9$ an untrue /atem5t (
 mat]ial fact4  7l7 ,antimicrobial      
susceptibility te/+ devices ,z a        
condition on designation ( a priority   
antimicrobial product pursuant to       
subsection 7k71 ! sponsor ( su* product 
%all--  7#a7 make su* product available 
to antimicrobial susceptibility te/     
device manufactur]s z e>ly 9 !          
developm5t process z possible2 &  7#b7  
submit a plan = su* availability to !   
,secret>y4  7m7 ,appropriate use ,z a   
condition on designation ( a priority   
antimicrobial product pursuant to       
subsection 7k71 ! sponsor ( su* product 
%all agree to--  7#a7 id5tify1 track1 & 
make publicly available antimicrobial   
resi/ance occurr5ce data & tr5ds = su*  
product2  7#b7 develop1 ?r\gh !         

sponsor's *ief compliance (fic]1 !      
sponsor's *ief m$ical (fic]1 or ano!r   
appropriate designee1 writt5 guidel9es &
 proc$ures to ensure appropriate use (  
su* product1 includ+ appropriate--  7,a7
 promotional practices2  7,b7 education 
to enc\rage appropriate use2  7,c7      
surveillance & monitor+2 &  7,d7        
/ew>d%ip2  7#c7 develop education &     
communications /rategies = educat+ heal?
 c>e pr(essionals ab\t su* product & its
 appropriate use2 &  7#d7 submit to !   
,food & ,drug ,adm9i/ration1 beg9n+ at  
#bd mon?s aft] ! date ( approval        
pursuant to section #eje7;c7 ( ?is ,act 
or section #cea7;a7 ( ! ,public ,heal?  
,s]vice ,act ( an application = su*     
product1 & e two ye>s !reaft] s long z  
su* product is m>ket$ 9 ! ,unit$ ,/ates1
 an assessm5t ( ! sponsor's /ew>d%ip    
activities relat+ to su* product4  7n7  
,/udies  7#a7 ,jo9t /udy by ,,hhs &     
,,gao  7,a7 ,9 g5]al ,beg9n+ #e ye>s    
aft] ! date ( enactm5t ( ! ,re-,valu+   
,anti-,microbial ,products ,act ( #bjah 

or on ! date t ! ,secret>y aw>ds ! fif? 
exclusivity ext5sion p]iod "u ?is       
section1 :i*ev] is e>li]1 ! ,director ( 
! ,c5t]s = ,disease ,control &          
,prev5tion & ,comptroll] ,g5]al ( !     
,unit$ ,/ates %all conduct a /udy ( !   
effectiv5ess ( ! program "u ?is section 
= ! developm5t ( priority antimicrobial 
products4  7,b7 ,cont5ts ( ! /udy ,9    
conduct+ ! /udy "u subp>agraph 7,a71 !  
,director ( ! ,c5t]s = ,disease ,control
 & ,prev5tion & ,comptroll] ,g5]al %all 
exam9e--  7i7 ! indications & usage =   
ea* drug = :i* an exclusivity ext5sion  
p]iod 0 aw>d$ "u subsection 7a72  7ii7 !
 developm5t ( resi/ance to ea* drug =   
:i* an exclusivity ext5sion p]iod 0     
aw>d$ "u subsection 7a72  7iii7 !       
private & societal value ( ea* drug =   
:i* an exclusivity ext5sion p]iod 0     
aw>d$ "u subsection 7a72 &  7iv7 !      
impact on pati5ts & public & private    
m>kets ( ! recipi5t drug ) respect to   
:i* a convey$ exclusivity ext5sion p]iod
 0 us$4  7,c7 ,report ,n lat] ?an #a ye>

 aft] ! date by :i* ! /udy "u           
subp>agraph 7,a7 is requir$ to beg9 "u  
subp>agraph 7,a71 ! ,director ( ! ,c5t]s
 = ,disease ,control & ,prev5tion &     
,comptroll] ,g5]al %all submit to !     
,congress a report conta9+ ! results ( !
 /udy4  7#b7 ,/udy by ,,gao ,n lat] ?an 
! date t is #e ye>s aft] ! date ( ! fir/
 aw>d "u subsection 7a71 ! ,comptroll]  
,g5]al ( ! ,unit$ ,/ates %all--  7,a7   
complete a /udy on ! actual & project$  
impacts ( ! program "u ?is section on   
,f$]al exp5ditures2 &  7,b7 submit a    
report on ! results ( su* /udy to !     
,congress4  7o7 ,report on              
reau?orization ,n lat] ?an #ahj days    
aft] ! ,secret>y aw>ds ! n9? exclusivity
 ext5sion p]iod "u ?is section1 !       
,committee %all submit a report to !    
,secret>y & ! ,congress conta9+         
recomm5dations on ! reau?orization ( ?is
 section1 includ+ recomm5dations on     
increas+ ! numb] ( aw>ds all[$ by       
subsection 7g77#a74  7p7 ,def9itions ,9 
?is section3 7#a7 ,! t]m biological     

product has ! mean+ giv5 to su* t]m 9   
section #cea7;i7 ( ! ,public ,heal?     
,s]vice ,act4  7#b7 ,! t]m ,committee   
means ! ,committee on ,develop+         
,critical ,ne$ ,antimicrobials e/abli%$ 
"u subsection 7j74  7#c7 ,! t]m convey$ 
exclusivity ext5sion p]iod means an     
exclusivity ext5sion p]iod convey$      
pursuant to subsection 7a74  7#d7 ,! t]m
 priority antimicrobial product means a 
product t is designat$ "u subsection    
7k74  7#e7 ,! t]m recipi5t drug means a 
drug approv$ "u section #eje receiv+ a  
convey$ exclusivity ext5sion p]iod4  4