,i  #aad? ,,congress  #a/ ,session  ,h4 
,r4 #bfbi  ,,9 ,,! ,,h\se ,,(           
,,repres5tatives  ,june #c1 #bjae ,mr4  
,%imkus 7= himself & ,mr4 ,g5e ,gre5 (  
,texas7 introduc$ ! foll[+ bill2 :i* 0  
ref]r$ to ! ,committee on ,en]gy &      
,comm]ce  ,a ,,bill  ,to am5d ! ,f$]al  
,food1 ,drug1 & ,cosmetic ,act ) respect
 to ! approval ( c]ta9 antibact]ial &   
antifungal drugs1 & = o!r purposes4  #a4
 ,%ort title ,?is ,act may be cit$ z !  
,antibiotic ,developm5t to ,advance     
,pati5t ,treatm5t ,act4  #b4 ,approval (
 c]ta9 drugs = use 9 a limit$ population
 ( pati5ts  7a7 ,purpose ,! purpose (   
?is section is to help exp$ite !        
developm5t & availability ( treatm5ts = 
s]i\s or life-?reat5+ bact]ial or fungal
 infections 9 pati5ts ) unmet ne$s1 :ile
 ma9ta9+ safety & effectiv5ess /&>ds =  
su* treatm5ts1 tak+ into acc\nt !       
sev]ity ( ! infection & ! availability  
or lack ( alt]native treatm5ts4  7b7    
,approval ( c]ta9 antibact]ial &        
antifungal drugs ,section #eje ( !      

,f$]al ,food1 ,drug1 & ,cosmetic ,act   
7#ba ,u4,s4,c4 #cee7 is am5d$ by add+ at
 ! end ! foll[+ new subsection3  7x7    
,approval ( c]ta9 antibact]ial &        
antifungal drugs = use 9 a limit$       
population ( pati5ts  7#a7 ,process ,at 
! reque/ ( ! sponsor ( an antibact]ial  
or antifungal drug t is int5d$ to treat 
a s]i\s or life-?reat5+ infection1 !    
,secret>y--  7,a7 may execute a writt5  
agreem5t ) ! sponsor on ! process =     
develop+ data to support an application 
= approval ( su* drug1 = use 9 a limit$ 
population ( pati5ts 9 accordance ) ?is 
subsection2  7,b7 %all proce$ 9         
accordance ) ?is subsection only if a   
writt5 agreem5t is rea*$ "u subp>agraph 
7,a72  7,c7 %all provide ! sponsor ) an 
opportunity to reque/ meet+s "u p>agraph
 7#b72  7,d7 if a writt5 agreem5t is    
rea*$ "u subp>agraph 7,a71 may approve !
 drug "u ?is subsection = su* use--  7i7
 9 a limit$ population ( pati5ts = :i*  
!re is an unmet m$ical ne$2  7ii7 bas$  
on a /reaml9$ developm5t program2 &     

7iii7 only if ! /&>ds = approval "u     
subsections 7c7 & 7d7 ( ?is section or  
lic5sure "u section #cea ( ! ,public    
,heal? ,s]vice ,act1 z applicable1 are  
met2 &  7,e7 9 approv+ a drug 9         
accordance ) ?is subsection1 subject to 
subp>agraph 7,d77iii71 may rely ^u--    
7i7 traditional endpo9ts1 alt]nate      
endpo9ts1 or a comb9ation ( traditional 
& alt]nate endpo9ts1 &1 z appropriate1  
data sets ( a limit$ size2 &  7ii7  7,i7
 additional data1 includ+ precl9ical1   
ph>macologic1 or pa?ophysiologic        
evid5ce2  7,,ii7 noncl9ical             
susceptibility & ph>macok9etic data2    
7,,iii7 data f phase #b cl9ical trials2 
&  7,,iv7 su* o!r confirmatory evid5ce z
 ! ,secret>y det]m9es appropriate to    
approve ! drug4  7#b7 ,=mal meet+s  7,a7
 ,9 g5]al ,to help exp$ite & facilitate 
! developm5t & review ( a drug = :i* a  
sponsor int5ds to reque/ approval 9     
accordance ) ?is subsection1 ! ,secret>y
 may1 at ! reque/ ( ! sponsor1 conduct  
meet+s t provide e>ly consultation1     

timely advice1 & suffici5t opportunities
 to develop an agreem5t describ$ 9      
p>agraph 7#a77;,a7 & help ! sponsor     
design & conduct a drug developm5t      
program z effici5tly z possible1 includ+
 ! foll[+ types ( meet+s3  7i7 ,an e>ly 
consultation meet+4  7ii7 ,an assessm5t 
meet+4  7iii7 ,a po/approval meet+4     
7,b7 ,no alt]+ ( goals ,no?+ 9 ?is      
p>agraph %all be con/ru$ to alt] agre$  
^u goals & proc$ures id5tifi$ 9 ! lett]s
 describ$ 9 section #aja7;b7 ( !        
,prescription ,drug ,us] ,fee ,am5dm5ts 
( #bjab4  7,c7 ,break?r\gh !rapies ,9 ! 
case ( a drug designat$ z a break?r\gh  
!rapy "u section #ejf7;a71 ! sponsor (  
su* drug may elect to utilize meet+s    
provid$ "u su* section ) respect to su* 
drug 9 lieu ( meet+s describ$ 9         
subp>agraph 7,a74  7#c7 ,label+         
requirem5t ,! label+ ( an antibact]ial  
or antifungal drug approv$ 9 accordance 
) ?is subsection %all conta9 ! /atem5t  
,limit$ ,population 9 a prom95t mann] & 
adjac5t to1 & n m prom95t ?an1 ! br& "n 

( ! product4 ,! prescrib+ in=mation =   
su* antibact]ial or antifungal drug     
requir$ by section #bja4eg ( title #ba1 
,code ( ,f$]al ,regulations 7or any     
successor regulation7 %all also include 
! foll[+ /atem5t3 ,?is drug is indicat$ 
= use 9 a limit$ & specific population (
 pati5ts44  7#d7 ,promotional mat]ials  
,! provisions ( section                 
#ejf7;c77#b77;,b7 %all apply ) respect  
to approval 9 accordance ) ?is          
subsection to ! same ext5t & 9 ! same   
mann] z su* provisions apply ) respect  
to accel]at$ approval 9 accordance )    
section #ejf7;c77#a74  7#e7 ,t]m9ation (
 requirem5ts or conditions ,if a drug is
 approv$ 9 accordance ) ?is subsection =
 an indication 9 a limit$ population (  
pati5ts & is subsequ5tly approv$ or     
lic5s$ "u ?is section or section #cea ( 
! ,public ,heal? ,s]vice ,act1 o!r ?an 9
 accordance ) ?is subsection1 =--  7,a7 
! same indication & ! same conditions ( 
use1 ! ,secret>y %all remove any label+ 
requirem5ts or po/m>ket+ conditions t 7 

made applicable to ! drug "u ?is        
subsection2 or  7,b7 a diff]5t          
indication or condition ( use1 !        
,secret>y %all n apply ! label+         
requirem5ts & po/m>ket+ conditions t 7  
made applicable to ! drug "u ?is        
subsection to ! subsequ5t approval ( !  
drug = su* diff]5t indication or        
condition ( use4  7#f7 ,relation to o!r 
provisions ,no?+ 9 ?is subsection %all  
be con/ru$ to prohibit ! approval ( a   
drug = use 9 a limit$ population (      
pati5ts 9 accordance ) ?is subsection1 9
 comb9ation )--  7,a7 an agreem5t on !  
design & size ( a cl9ical trial pursuant
 to subp>agraphs 7,b7 & 7,c7 (          
subsection 7b77#e72  7,b7 designation & 
treatm5t ( ! drug z a break?r\gh !rapy  
"u section #ejf7;a72  7,c7 designation &
 treatm5t ( ! drug z a fa/ track product
 "u section #ejf7;b72 or  7,d7 accel]at$
 approval ( ! drug 9 accordance )       
section #ejf7;c74  7#g7 ,rule (         
con/ruction ,no?+ 9 ?is subsection %all 
be con/ru$--  7,a7 to alt] ! /&>ds (    

evid5ce "u subsection 7c7 or 7d7        
7includ+ ! sub/antial evid5ce /&>d 9    
subsection 7d772  7,b7 to waive or      
o!rwise preclude ! application (        
requirem5ts "u subsection 7o72  7,c7 to 
o!rwise1 9 any way1 limit ! au?ority ( !
 ,secret>y to approve products pursuant 
to ?is ,act & ! ,public ,heal? ,s]vice  
,act z au?oriz$ prior to ! date (       
enactm5t ( ?is subsection2 or  7,d7 to  
re/rict 9 any mann]1 ! prescrib+ (      
antibiotics or o!r products by heal? c>e
 provid]s1 or to o!rwise limit or       
re/rict ! practice ( heal? c>e4  7#h7   
,effective imm$iately ,! ,secret>y %all 
h ! au?orities ve/$ 9 ! ,secret>y by ?is
 subsection beg9n+ on ! date ( enactm5t 
( ?is subsection1 irrespective ( :5 &   
:e!r ! ,secret>y promulgates f9al       
regulations or guidance4  7#i7          
,def9itions ,9 ?is subsection3 7,a7     
,e>ly consultation meet+ ,! t]m e>ly    
consultation meet+ means a              
pre-inve/igational new drug meet+ or an 
end-(-phase #a meet+ t--  7i7 is        

conduct$ to review & rea* a writt5      
agreem5t-- 7,i7 on ! scope ( ! /reaml9$ 
developm5t plan = a drug = :i* a sponsor
 int5ds to reque/ approval 9 accordance 
) ?is subsection2 &  7,,ii7 :i*1 z      
appropriate1 may include agreem5t on !  
design & size ( necess>y precl9ical &   
cl9ical /udies e>ly 9 ! developm5t      
process1 includ+ cl9ical trials ^: data 
are int5d$ to =m ! prim>y basis = an    
effectiv5ess claim2 &  7ii7 provides an 
opportunity to discuss expectations ( ! 
,secret>y reg>d+ /udies or o!r in=mation
 t ! ,secret>y deems appropriate =      
purposes ( apply+ p>agraph 7#e71 relat+ 
to ! t]m9ation ( label+ requirem5ts or  
po/m>ket+ conditions4  7,b7 ,assessm5t  
meet+ ,! t]m assessm5t meet+ means an   
end-(-phase #b meet+1 pre-new drug      
application meet+1 or pre-biologics     
lic5se application meet+ conduct$ to    
resolve que/ions & issues rais$ dur+ !  
c\rse ( cl9ical inve/igations1 & details
 address$ 9 ! writt5 agreem5t reg>d+    
po/approval commitm5ts or expansion (   

approv$ uses4  7,c7 ,po/approval meet+  
,! t]m po/approval meet+ means a meet+  
foll[+ initial approval or lic5sure ( ! 
drug = use 9 a limit$ population1 to    
discuss any issues id5tifi$ by !        
,secret>y or ! sponsor reg>d+           
po/approval commitm5ts or expansion (   
approv$ uses4  4  7c7 ,guidance ,n lat] 
?an #ah mon?s aft] ! date ( enactm5t (  
?is ,act1 ! ,secret>y ( ,heal? & ,human 
,s]vices1 act+ ?r\gh ! ,commission] (   
,food & ,drugs1 %all issue draft        
guidance describ+ crit]ia1 process1 &   
o!r g5]al consid]ations = demon/rat+ !  
safety & effectiv5ess ( antibact]ial &  
antifungal drugs to be approv$ = use 9 a
 limit$ population 9 accordance )       
section #eje7x7 ( ! ,f$]al ,food1 ,drug1
 & ,cosmetic ,act1 z add$ by subsection 
7b74  7d7 ,con=m+ am5dm5ts  7#a7        
,lic5sure ( c]ta9 biological products   
,section #cea7;j7 ( ! ,public ,heal?    
,s]vice ,act 7#db ,u4,s4,c4 #bfb7;j77 is
 am5d$-- 7,a7 by /rik+ 7j7 & ins]t+     
7j77#a72  7,b7 by ins]t+ #eje7x71 aft]  

#eje7p712 &  7,c7 by add+ at ! end !    
foll[+ new p>agraph3  7#b7 ,9 apply+    
section #eje7x7 ( ! ,f$]al ,food1 ,drug1
 & ,cosmetic ,act to ! lic5sure (       
biological products "u ?is section--    
7,a7 ref]5ces to an antibact]ial or     
antifungal drug t is int5d$ to treat a  
s]i\s or life-?reat5+ infection %all be 
con/ru$ to ref] to a biological product 
int5d$ to treat a s]i\s or life-?reat5+ 
bact]ial or fungal infection2 &  7,b7   
ref]5ces to approval ( a drug "u section
 #eje7;c7 ( su* ,act %all be con/ru$ to 
ref] to a lic5sure ( a biological       
product "u subsection 7a7 ( ?is section4
  4  7#b7 ,misbr&+ ,section #ejb ( !    
,f$]al ,food1 ,drug1 & ,cosmetic ,act   
7#ba ,u4,s4,c4 #ceb7 is am5d$ by add+ at
 ! end ! foll[+ new subsection3  7dd7   
,if x is a drug approv$ 9 accordance )  
section #eje7x7 & its label+ does n meet
 ! requirem5ts "u p>agraph 7#c7 ( su*   
subsection1 subject to p>agraph 7#e7 (  
su* subsection4  4  7e7 ,evaluation     
7#a7 ,assessm5t ,n lat] ?an #dh mon?s   

aft] ! date ( enactm5t ( ?is ,act1 !    
,secret>y ( ,heal? & ,human ,s]vices    
%all publi% = public comm5t an assessm5t
 ( ! program e/abli%$ "u section #eje7x7
 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic   
,act1 z add$ by subsection 7b74 ,su*    
assessm5t %all det]m9e if ! limit$-use  
pa?way e/abli%$ "u su* section #eje7x7  
has improv$ or is likely to improve     
pati5t access to novel antibact]ial or  
antifungal treatm5ts & assess h[ !      
pa?way c\ld be exp&$ to cov] products = 
s]i\s or life-?reat5+ diseases or       
conditions beyond bact]ial & fungal     
infections4  7#b7 ,meet+ ,n lat] ?an #ij
 days aft] ! date ( ! publication ( su* 
assessm5t1 ! ,secret>y1 act+ ?r\gh !    
,commission] ( ,food & ,drugs %all hold 
a public meet+ to discuss ! f9d+s ( !   
assessm5t1 dur+ :i* public /akehold]s   
may pres5t _! views on ! success ( !    
program e/abli%$ "u section #eje7x7 ( ! 
,f$]al ,food1 ,drug1 & ,cosmetic ,act1 z
 add$ by subsection 7b71 & !            
appropriat5ess ( exp&+ su* program4  7f7

 ,expansion ( program ,if ! ,secret>y ( 
,heal? & ,human ,s]vices det]m9es1 bas$ 
on ! assessm5t "u subsection 7e77#a71   
evaluation ( ! assessm5t1 & any o!r     
relevant in=mation1 t ! public heal?    
w\ld b5efit f expansion ( ! limit$-use  
pa?way e/abli%$ "u section #eje7x7 ( !  
,f$]al ,food1 ,drug1 & ,cosmetic ,act 7z
 add$ by subsection 7b77 beyond ! drugs 
approv$ 9 accordance ) su* section1 !   
,secret>y may exp& su* limit$-use pa?way
 9 accordance ) su* a det]m9ation4 ,!   
approval ( any drugs "u any su*         
expansion %all be subject to !          
consid]ations & requirem5ts describ$ 9  
su* section #eje7x7 = purposes (        
expansion to o!r s]i\s or life-?reat5+  
diseases or conditions4  7g7 ,monitor+  
,! ,public ,heal? ,s]vice ,act is am5d$ 
by ins]t+ aft] section #cag,t 7#db      
,u4,s4,c4 #bdg;b-#bb7 ! foll[+3  #cag,u4
 ,monitor+ antibact]ial & antifungal    
drug use & resi/ance  7a7 ,monitor+ ,!  
,secret>y %all use an appropriate       
monitor+ sy/em to monitor-- 7#a7 ! use (

 antibact]ial & antifungal drugs1       
includ+ ^? receiv+ approval or lic5sure 
= a limit$ population pursuant to       
section #eje7x7 ( ! ,f$]al ,food1 ,drug1
 & ,cosmetic ,act2 &  7#b7 *anges 9     
bact]ial & fungal resi/ance to drugs4   
7b7 ,public availability ( data ,!      
,secret>y %all make summ>ies ( ! data   
d]iv$ f monitor+ "u ?is section publicly
 available = ! purposes (--  7#a7       
improv+ ! monitor+ ( important tr5ds 9  
antibact]ial & antifungal resi/ance2 &  
7#b7 ensur+ appropriate /ew>d%ip (      
antibact]ial & antifungal drugs1 includ+
 ^? receiv+ approval or lic5sure = a    
limit$ population pursuant to section   
#eje7x7 ( ! ,f$]al ,food1 ,drug1 &      
,cosmetic ,act4  4  #c4 ,susceptibility 
te/ int]pretive crit]ia = microorganisms
  7a7 ,9 g5]al ,section #eaa ( ! ,f$]al 
,food1 ,drug1 & ,cosmetic ,act 7#ba     
,u4,s4,c4 #cfj;a7 is am5d$ to read z    
foll[s3  #eaa4 ,id5tify+ & updat+       
susceptibility te/ int]pretive crit]ia =
 microorganisms  7a7 ,purpose2          

,id5tification ( crit]ia  7#a7 ,purpose 
,! purpose ( ?is section is to provide !
 ,secret>y ) an exp$it$1 flexible me?od 
=-- 7,a7 cle>ance or prem>ket approval (
 antimicrobial susceptibility te/+      
devices utiliz+ updat$1 recogniz$       
susceptibility te/ int]pretive crit]ia  
to *>act]ize ! 9 vitro susceptibility ( 
p>ticul> bact]ia1 fungi1 or o!r         
microorganisms to antimicrobial drugs2 &
  7,b7 provid+ public notice ( !        
availability ( recogniz$ int]pretive    
crit]ia to meet prem>ket submission     
requirem5ts or o!r requirem5ts "u ?is   
,act = antimicrobial susceptibility te/+
 devices4  7#b7 ,9 g5]al ,! ,secret>y   
%all id5tify appropriate susceptibility 
te/ int]pretive crit]ia ) respect to    
antimicrobial drugs--  7,a7 if su*      
crit]ia are available on ! date (       
approval ( ! drug "u section #eje ( ?is 
,act or lic5sure ( ! drug "u section    
#cea ( ! ,public ,heal? ,s]vice ,act 7z 
applicable71 ^u su* approval or         
lic5sure2 or  7,b7 if su* crit]ia are   

unavailable on su* date1 on ! date on   
:i* su* crit]ia are available = su*     
drug4  7#c7 ,bases = initial            
id5tification ,! ,secret>y %all id5tify 
appropriate susceptibility te/          
int]pretive crit]ia "u p>agraph 7#b71   
bas$ on ! ,secret>y's review (1 to !    
ext5t available & relevant--  7,a7      
precl9ical & cl9ical data1 includ+      
ph>macok9etic1 ph>macodynamic1 &        
epidemiological data2  7,b7 ,bayesian & 
ph>macometric /ati/ical me?odologies2 & 
7,c7 su* o!r evid5ce & in=mation z !    
,secret>y consid]s appropriate4  7b7    
,susceptibility te/ ,int]pretive        
,crit]ia ,website  7#a7 ,9 g5]al ,n lat]
 ?an #a ye> aft] ! date ( ! enactm5t ( !
 ,antibiotic ,developm5t to ,advance    
,pati5t ,treatm5t ,act1 ! ,secret>y %all
 e/abli%1 & ma9ta9 !reaft]1 on ! website
 ( ! ,food & ,drug ,adm9i/ration1 a     
d$icat$ website t conta9s a li/ ( any   
appropriate new or updat$ susceptibility
 te/ int]pretive crit]ia /&>ds 9        
accordance ) p>agraph 7#b7 7ref]r$ to 9 

?is section z ! ,int]pretive ,crit]ia   
,website74  7#b7 ,li/+ ( susceptibility 
te/ int]pretive crit]ia /&>ds  7,a7 ,9  
g5]al ,! li/ describ$ 9 p>agraph 7#a7   
%all consi/ ( any new or updat$         
susceptibility te/ int]pretive crit]ia  
/&>ds t are--  7i7 e/abli%$ by a        
nationally or int]nationally recogniz$  
/&>d developm5t organization t-- 7,i7   
e/abli%es & ma9ta9s proc$ures to address
 pot5tial conflicts ( int]e/ & ensure   
transp>5t decisionmak+2  7,,ii7 holds   
op5 meet+s to ensure t !re is an        
opportunity = public input by int]e/$   
p>ties1 & e/abli%es & ma9ta9s processes 
to ensure t su* input is consid]$ 9     
decisionmak+2 &  7,,iii7 p]mits its     
/&>ds to be made publicly available1    
?r\gh ! ,national ,libr>y ( ,m$ic9e or  
ano!r simil> s\rce acceptable to !      
,secret>y2 &  7ii7 recogniz$ 9 :ole1 or 
9 "p1 by ! ,secret>y "u subsection 7c74 
7,b7 ,o!r li/ ,! ,int]pretive ,crit]ia  
,website %all1 9 addition to ! li/      
describ$ 9 subp>agraph 7,a71 include a  

li/ ( int]pretive crit]ia1 if any1 t !  
,secret>y has det]m9$ to be appropriate 
) respect to legally m>ket$             
antimicrobial drugs1 :]e--  7i7 !       
,secret>y does n recognize1 9 :ole or 9 
"p1 an int]pretive crit]ia /&>d describ$
 "u subp>agraph 7,a7 o!rwise applicable 
to su* a drug2  7ii7 ! ,secret>y )draws 
"u subsection 7c77#a77;,b7 recognition (
 a /&>d1 9 :ole or 9 "p1 o!rwise        
applicable to su* a drug2  7iii7 !      
,secret>y approves an application "u    
section #eje ( ?is ,act or section #cea 
( ! ,public ,heal? ,s]vice ,act1 z      
applicable1 ) respect to m>ket+ ( su* a 
drug = :i* !re are no relevant          
int]pretive crit]ia includ$ 9 a /&>d    
recogniz$ by ! ,secret>y "u subsection  
7c72 or  7iv7 because ! *>act]i/ics (   
su* a drug diff] f o!r drugs ) ! same   
active +r$i5t1 ! int]pretive crit]ia )  
respect to su* drug--  7,i7 diff] f     
o!rwise applicable int]pretive crit]ia  
includ$ 9 a /&>d li/$ "u subp>agraph    
7,a7 or int]pretive crit]ia o!rwise li/$

 "u ?is subp>agraph2 &  7,,ii7 are      
det]m9$ by ! ,secret>y to be appropriate
 = ! drug4  7,c7 ,requir$ /atem5ts (    
limitations ( in=mation ,! ,int]pretive 
,crit]ia ,website %all include ! foll[+3
  7i7 ,a /atem5t t-- 7,i7 ! website     
provides in=mation ab\t ! susceptibility
 ( bact]ia1 fungi1 or o!r microorganisms
 to a c]ta9 drug 7or drugs72 &  7,,ii7 !
 safety & efficacy ( ! drug 9 treat+    
cl9ical infections due to su* bact]ia1  
fungi1 or o!r microorganisms may n h be5
 e/abli%$ 9 adequate & well-controll$   
cl9ical trials & ! cl9ical significance 
( su* susceptibility in=mation 9 su*    
trials is unkn[n4  7ii7 ,a /atem5t t    
directs heal? c>e practition]s to       
consult ! approv$ product label+ =      
specific drugs to det]m9e ! uses = :i* !
 ,food & ,drug ,adm9i/ration has approv$
 ! product4  7iii7 ,any o!r /atem5t t ! 
,secret>y det]m9es appropriate to       
adequately convey ! limitations ( ! data
 support+ susceptibility te/ int]pretive
 crit]ia /&>d li/$ on ! website4  7#c7  

,notice ,n lat] ?an ! date on :i* !     
,int]pretive ,crit]ia ,website is       
e/abli%$1 ! ,secret>y %all publi% a     
notice ( t e/abli%m5t 9 ! ,f$]al        
,regi/]4  7#d7 ,inapplicability (       
misbr&+ provision ,! inclusion 9 !      
approv$ label+ ( an antimicrobial drug (
 a ref]5ce or hyp]l9k to ! ,int]pretive 
,crit]ia ,website1 9 & ( itself1 %all n 
cause ! drug to be misbr&$ 9 violation (
 section #ejb1 or ! regulations         
promulgat$ !reund]4  7#e7 ,trade secrets
 & confid5tial in=mation ,no?+ 9 ?is    
section %all be con/ru$ z au?oriz+ !    
,secret>y to disclose any in=mation t is
 a trade secret or confid5tial in=mation
 subject to section #eeb7;b77#d7 ( title
 #e1 ,unit$ ,/ates ,code4  7c7          
,recognition ( susceptibility te/       
int]pretive crit]ia f /&>d developm5t   
organizations  7#a7 ,9 g5]al ,beg9n+ on 
! date ( ! e/abli%m5t ( ! ,int]pretive  
,crit]ia ,website1 & at lea/ e #f mon?s 
!reaft]1 ! ,secret>y %all--  7,a7       
evaluate any appropriate new or updat$  

susceptibility te/ int]pretive crit]ia  
/&>ds e/abli%$ by a nationally or       
int]nationally recogniz$ /&>d developm5t
 organization describ$ 9 subsection     
7b77#b77;,a77i72 &  7,b7 publi% on !    
public website ( ! ,food & ,drug        
,adm9i/ration a notice-- 7i7 )draw+     
recognition ( any diff]5t susceptibility
 te/ int]pretive crit]ia /&>d1 9 :ole or
 9 "p2  7ii7 recogniz+ ! new or updat$  
/&>ds2  7iii7 recogniz+ "o or m p>ts ( !
 new or updat$ int]pretive crit]ia      
specifi$ 9 su* a /&>d & decl9+ to       
recognize ! rema9d] ( su* /&>d2 &  7iv7 
mak+ any necess>y updates to ! li/s "u  
subsection 7b77#b74  7#b7 ,bases =      
updat+ int]pretive crit]ia /&>ds ,9     
evaluat+ new or updat$ susceptibility   
te/ int]pretive crit]ia /&>ds "u        
p>agraph 7#a77;,a71 ! ,secret>y may     
consid]--  7,a7 ! ,secret>y's           
det]m9ation t su* a /&>d is n applicable
 to a p>ticul> drug because !           
*>act]i/ics ( ! drug diff] f o!r drugs )
 ! same active +r$i5t2  7,b7 in=mation  

provid$ by int]e/$ ?ird p>ties1 includ+ 
public comm5t on ! annual compilation ( 
notices publi%$ "u p>agraph 7#c72  7,c7 
any bases us$ to id5tify susceptibility 
te/ int]pretive crit]ia "u subsection   
7a77#b72 &  7,d7 su* o!r in=mation or   
factors z ! ,secret>y det]m9es          
appropriate4  7#c7 ,annual compilation (
 notices ,ea* ye>1 ! ,secret>y %all     
compile ! notices publi%$ "u p>agraph   
7#a77;,b7 & publi% su* compilation 9 !  
,f$]al ,regi/] & provide = public       
comm5t4 ,if ! ,secret>y receives        
comm5ts1 ! ,secret>y w review su*       
comm5ts &1 if ! ,secret>y det]m9es      
appropriate1 update pursuant to ?is     
subsection susceptibility te/           
int]pretive crit]ia /&>ds--  7,a7       
recogniz$ by ! ,secret>y "u ?is         
subsection2 or  7,b7 o!rwise li/$ on !  
,int]pretive ,crit]ia ,website "u       
subsection 7b77#b74  7#d7 ,relation to  
section #ead7;c7 ,any susceptibility te/
 int]pretive /&>d recogniz$ "u ?is      
subsection or any crit]ia o!rwise li/$  

"u subsection 7b77#b77;,b7 %all be deem$
 to be recogniz$ z a /&>d by ! ,secret>y
 "u section #ead7;c77#a74  7#e7         
,volunt>y use ( int]pretive crit]ia     
,no?+ 9 ?is section prohibits a p]son f 
seek+ approval or cle>ance ( a drug or  
device1 or *anges to ! drug or ! device1
 on ! basis ( susceptibility te/        
int]pretive crit]ia /&>ds :i* diff] f ^?
 recogniz$ pursuant to p>agraph 7#a74   
7d7 ,antimicrobial drug label+  7#a7    
,drugs m>ket$ prior to e/abli%m5t (     
,int]pretive ,crit]ia ,website ,)       
respect to an antimicrobial drug        
lawfully introduc$ or deliv]$ =         
introduction into int]/ate comm]ce =    
comm]cial di/ribution be=e ! e/abli%m5t 
( ! ,int]pretive ,crit]ia ,website1 a   
hold] ( an approv$ application "u       
section #eje or section #cea ( ! ,public
 ,heal? ,s]vice ,act1 z applicable1 =   
ea* su* drug--  7,a7 n lat] ?an #a ye>  
aft] e/abli%m5t ( ! ,int]pretive        
,crit]ia ,website1 %all submit to !     
,secret>y a supplem5tal application =   

purposes ( *ang+ ! drug's label+ to     
sub/itute a ref]5ce or hyp]l9k to su*   
,website = any susceptibility te/       
int]pretive crit]ia & relat$ in=mation2 
&  7,b7 may beg9 di/ribution ( ! drug   
involv$ ^u receipt by ! ,secret>y ( !   
supplem5tal application = su* *ange4    
7#b7 ,drugs m>ket$ subsequ5t to         
e/abli%m5t ( ,int]pretive ,crit]ia      
,website ,) respect to antimicrobial    
drugs lawfully introduc$ or deliv]$ =   
introduction into int]/ate comm]ce =    
comm]cial di/ribution on or aft] ! date 
( ! e/abli%m5t ( ! ,int]pretive ,crit]ia
 ,website1 ! label+ = su* a drug %all   
include1 9 lieu ( susceptibility te/    
int]pretive crit]ia & relat$ in=mation1 
a ref]5ce to su* ,website4  7e7 ,special
 condition = m>ket+ ( antimicrobial     
susceptibility te/+ devices  7#a7 ,9    
g5]al ,not)/&+ sections #eja1 #ejb1     
#eaj1 #eac1 & #eae1 if ! conditions     
specifi$ 9 p>agraph 7#b7 are met 79     
addition to o!r applicable provisions "u
 ?is *apt]7 ) respect to an             

antimicrobial susceptibility te/+ device
 describ$ 9 subsection 7f77#a71 !       
,secret>y may au?orize ! m>ket+ ( su*   
device = a use describ$ 9 su*           
subsection4  7#b7 ,conditions applicable
 to antimicrobial susceptibility te/+   
devices ,! conditions specifi$ 9 ?is    
p>agraph are ! foll[+3 7,a7 ,! device is
 us$ to make a det]m9ation (            
susceptibility us+ susceptibility te/   
int]pretive crit]ia t are--  7i7 includ$
 9 a /&>d recogniz$ by ! ,secret>y "u   
subsection 7c72 or  7ii7 o!rwise li/$ on
 ! ,int]pretive ,crit]ia ,website "u    
subsection 7b77#b74  7,b7 ,! label+ (   
su* device prom95tly & conspicu\sly--   
7i7 includes a /atem5t t--  7,i7 !      
device provides in=mation ab\t !        
susceptibility ( bact]ia & fungi to     
c]ta9 drugs2 &  7,,ii7 ! safety &       
efficacy ( su* drugs 9 treat+ cl9ical   
infections due to su* bact]ia or fungi  
may n h be5 e/abli%$ 9 adequate &       
well-controll$ cl9ical trials & !       
cl9ical significance ( su*              

susceptibility in=mation 9 ^? in/ances  
is unkn[n2  7ii7 includes a /atem5t     
direct+ heal? c>e practition]s to       
consult ! approv$ label+ = drugs te/$   
us+ su* a device1 to det]m9e ! uses =   
:i* ! ,food & ,drug ,adm9i/ration has   
approv$ su* drugs2 &  7iii7 includes any
 o!r /atem5t ! ,secret>y det]m9es       
appropriate to adequately convey !      
limitations ( ! data support+ !         
int]pretive crit]ia describ$ 9          
subp>agraph 7,a74  7f7 ,def9itions ,9   
?is section3 7#a7 ,! t]m antimicrobial  
susceptibility te/+ device means a      
device t utilizes susceptibility te/    
int]pretive crit]ia to det]m9e & report 
! 9 vitro susceptibility ( c]ta9        
microorganisms to a drug 7or drugs74    
7#b7 ,! t]m qualifi$ infecti\s disease  
product means a qualifi$ infecti\s      
disease product designat$ "u section    
#eje;,e7d74  7#c7 ,! t]m susceptibility 
te/ int]pretive crit]ia means--  7,a7 "o
 or m specific num]ical values :i*      
*>act]ize ! susceptibility ( bact]ia or 

o!r microorganisms to ! drug te/$2 &    
7,b7 relat$ categorizations ( su*       
susceptibility1 includ+ categorization (
 ! drug z susceptible1 int]m$iate1      
resi/ant1 or su* o!r t]m z ! ,secret>y  
det]m9es appropriate4  7#d7  7,a7 ,! t]m
 antimicrobial drug means1 subject to   
subp>agraph 7,b71 a sy/emic antibact]ial
 or antifungal drug t-- 7i7 is int5d$ = 
human use 9 ! treatm5t ( a disease or   
condition caus$ by a bact]ium or fungus2
  7ii7 may include a qualifi$ infecti\s 
disease product designat$ "u section    
#eje;,e7d72 &  7iii7 is subject to      
section #ejc7;b77#a74  7,b7 ,if provid$ 
by ! ,secret>y ?r\gh regulations1 su*   
t]m may include-- 7i7 drugs o!r ?an     
sy/emic antibact]ial & antifungal drugs2
 &  7ii7 biological products 7z su* t]m 
is def9$ 9 section #cea ( ! ,public     
,heal? ,s]vice ,act7 to ! ext5t su*     
products exhibit antimicrobial activity4
  7g7 ,rule ( con/ruction ,no?+ 9 ?is   
section %all be con/ru$-- 7#a7 to alt] !
 /&>ds ( evid5ce--  7,a7 "u subsection  

7c7 or 7d7 ( section #eje1 includ+ !    
sub/antial evid5ce /&>d 9 section       
#eje7;d71 or "u section #cea ( ! ,public
 ,heal? ,s]vice ,act 7z applicable72 or 
7,b7 ) respect to m>ket+ au?orization = 
devices1 "u section #eaj1 #eac1 or #eae2
  7#b7 to apply ) respect to any drug1  
device1 or biological product1 9 any    
context o!r ?an--  7,a7 an antimicrobial
 drug2 or  7,b7 an antimicrobial        
susceptibility te/+ device t uses       
susceptibility te/ int]pretive crit]ia  
to *>act]ize & report ! 9 vitro         
susceptibility ( c]ta9 bact]ia1 fungi1  
or o!r microorganisms to antimicrobial  
drugs 9 accordance ) ?is section2 or    
7#c7 unless specifically /at$1 to h any 
effect on au?orities provid$ "u o!r     
sections ( ?is ,act1 includ+ any        
regulations issu$ "u su* sections4  4   
7b7 ,con=m+ am5dm5ts  7#a7 ,repeal (    
relat$ au?ority ,section #aaaa ( ! ,food
 & ,drug ,adm9i/ration ,am5dm5ts ,act ( 
#bjjg 7#db ,u4,s4,c4 #bdg;d-#e;a2 relat+
 to id5tification ( cl9ically           

susceptible conc5trations (             
antimicrobials7 is repeal$4  7#b7       
,misbr&+ ,section #ejb ( ! ,f$]al ,food1
 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 
#ceb71 z am5d$ by section #a1 is fur!r  
am5d$ by add+ at ! end ! foll[+3  7ee7  
,if x is an antimicrobial drug & its    
label+ fails to con=m ) ! requirem5ts "u
 section #eaa7;d74  4  7#c7 ,recognition
 ( int]pretive crit]ia z device /&>d    
,section #ead7;c77#a77;,a7 ( ! ,f$]al   
,food1 ,drug1 & ,cosmetic ,act 7#ba     
,u4,s4,c4 #cfj;d7c77#a77;,a77 is am5d$  
by ins]t+ aft] ! ,secret>y %all1 by     
publication 9 ! ,f$]al ,regi/] ! foll[+3
 7or1 ) respect to susceptibility te/   
int]pretive crit]ia or /&>ds recogniz$  
or o!rwise li/$ "u section #eaa1 by po/+
 on ! ,int]pretive ,crit]ia ,website 9  
accordance ) su* section74  7c7 ,report 
to ,congress ,n lat] ?an two ye>s aft] !
 date ( enactm5t ( ?is ,act1 ! ,secret>y
 ( ,heal? & ,human ,s]vices %all submit 
to ! ,committee on ,en]gy & ,comm]ce ( !
 ,h\se ( ,repres5tatives & ! ,committee 

on ,heal?1 ,education1 ,labor1 &        
,p5sions ( ! ,s5ate a report on !       
progress made 9 implem5t+ section #eaa (
 ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act
 7#ba ,u4,s4,c4 #cfj;a71 z am5d$ by ?is 
section4  7d7 ,reque/s = updates to     
,int]pretive ,crit]ia ,website ,*apt]   
#ce ( title #dd1 ,unit$ ,/ates ,code1   
%all n apply to ! collection ( in=mation
 f int]e/$ p>ties reg>d+ ! updat+ ( li/s
 "u p>agraph 7#b7 ( subsection 7b7 (    
section #eaa ( ! ,f$]al ,food1 ,drug1 & 
,cosmetic ,act 7z am5d$ by subsection   
7a77 & po/$ on ! ,int]pretive ,crit]ia  
,website e/abli%$ "u p>agraph 7#a7 ( su*
 subsection 7b74  7e7 ,no effect on     
heal? c>e practice ,no?+ 9 ?is ,act     
7includ+ ! am5dm5ts made by ?is ,act7   
%all be con/ru$ to re/rict1 9 any mann]1
 ! prescrib+ or adm9i/]+ ( antibiotics  
or o!r products by heal? c>e            
practition]s1 or to limit ! practice (  
heal? c>e4