,,ii  #aag? ,,congress  #b;d ,session   
,s4 #cdih  ,,9 ,,! ,,s5ate ,,( ,,!      
,,unit$ ,,/ates  ,janu>y #ac            
7legislative day1 ,janu>y #aj71         
#bjbb,mr4 ,kelly 7= himself1 ,ms4       
,s9ema1 & ,mrs4 ,fe9/e97 introduc$ !    
foll[+ bill2 :i* 0 read twice & ref]r$  
to ! ,committee on ,heal?1 ,education1  
,labor1 & ,p5sions  ,a ,,bill  ,to      
support endemic fungal disease rese>*1  
inc5tivize fungal vacc9e developm5t1    
discov] new antifungal !rapies &        
diagno/ics1 & = o!r purposes4  #a4 ,%ort
 title  7a7 ,9 g5]al ,?is ,act may be   
cit$ z ! ,f9d+ ,orphan-disease ,rem$ies 
,) ,antifungal ,rese>* & ,developm5t    
,act ( #bjbb or ! ,,=w>d ,act ( #bjbb4  
7b7 ,table ( cont5ts ,! table ( cont5ts 
= ?is ,act is z foll[s3 ,sec4 #a4 ,%ort 
title4,sec4 #b4 ,cont9u+ support =      
rese>* on endemic fungal diseases4,sec4 
#c4 ,endemic fungal disease work+       
gr\p4,sec4 #d4 ,,fda guidance = indu/ry 
on developm5t ( diagno/ics & antifungal 
drugs & vacc9es = ,valley ,fev]4,sec4   

#e4 ,priority review2 fa/ track         
product4,sec4 #f4 ,priority review v\*]s
 = products = prev5tion or treatm5t (   
endemic fungal diseases4,sec4 #g4       
,combat+ antimicrobial resi/ance        
bioph>maceutical accel]ator program4    
#b4 ,cont9u+ support = rese>* on endemic
 fungal diseases ,! ,public ,heal?      
,s]vice ,act is am5d$ by ins]t+ aft]    
section #ddg;,c ( su* ,act 7#db         
,u4,s4,c4 #bhe;f-#d7 ! foll[+ new       
section3  #ddg;,d4 ,endemic fungal      
diseases  7a7 ,9 g5]al ,! ,director ( ! 
,in/itute %all-- 7#a7 cont9ue to conduct
 or support epidemiological1 basic1     
translational1 & cl9ical rese>* relat$  
to endemic fungal diseases1 includ+     
coccidioidomycosis 7commonly kn[n z &   
ref]r$ to 9 ?is section z ,valley       
,fev]72 &  7#b7 subject to !            
availability ( appropriations1 make     
grants to1 or ent] into contracts )1    
public or nonpr(it private entities to  
conduct su* rese>*4  7b7 ,reports ,!    
,director ( ! ,in/itute %all ensure t   

ea* tri5nial report "u section #djc     
includes in=mation on actions und]tak5  
by ! ,national ,in/itutes ( ,heal? to   
c>ry out subsection 7a7 ) respect to    
endemic fungal diseases1 includ+ ,valley
 ,fev]4  7c7 ,au?orization (            
appropriations ,9 addition to o!r am\nts
 available = ! purposes ( c>ry+ out ?is 
section1 !re is au?oriz$ to be          
appropriat$ to c>ry out ?is section     
#bj1jjj1jjj = ea* ( fiscal ye>s #bjbb   
?r\gh #bjbf = su* purpose4  4  #c4      
,endemic fungal disease work+ gr\p  7a7 
,e/abli%m5t ,! ,secret>y ( ,heal? &     
,human ,s]vices 7ref]r$ to 9 ?is section
 z ! ,secret>y7 %all e/abli% a work+    
gr\p1 to be kn[n z ! ,endemic ,fungal   
,disease ,work+ ,gr\p 7ref]r$ to 9 ?is  
section z ! ,work+ ,gr\p71 compris$ (   
repres5tatives ( appropriate ,f$]al     
ag5cies & o!r non-,f$]al entities-- 7#a7
 to provide exp]tise & to review all    
ef=ts )9 ! ,dep>tm5t ( ,heal? & ,human  
,s]vices relat$ to endemic fungal       
disease2  7#b7 to help ensure int]ag5cy 

coord9ation & m9imize ov]lap ) respect  
to su* disease2 &  7#c7 to exam9e rese>*
 priorities ) respect to su* disease4   
7b7 ,responsibilities ,! ,work+ ,gr\p   
%all-- 7#a7 n lat] ?an #b ye>s aft] !   
date ( enactm5t ( ?is ,act1 develop or  
update a summ>y (-- 7,a7 ongo+ endemic  
fungal disease rese>*1 includ+ rese>*   
relat$ to causes1 prev5tion1 treatm5t1  
surveillance1 diagnosis1 diagno/ics1    
duration ( illness1 & int]v5tion =      
individuals ) an endemic fungal disease2
  7,b7 advances made pursuant to su*    
rese>*2  7,c7 ! impact ( viral          
respiratory illnesses1 includ+          
,,covid-#ai1 & fungal lung diseases &   
pneumonias2  7,d7 ,f$]al activities     
relat$ to endemic fungal disease1       
includ+-- 7i7 epidemiological activities
 relat$ to endemic fungal disease2 &    
7ii7 basic1 cl9ical1 & translational    
endemic fungal disease rese>* relat$ to 
! pa?og5esis1 prev5tion1 diagnosis1 &   
treatm5t ( endemic fungal disease2  7,e7
 gaps 9 endemic fungal disease rese>*   

describ$ 9 subp>agraph 7,d77ii72  7,f7 !
 ,work+ ,gr\p's meet+s requir$ "u       
subsection 7d72 &  7,g7 ! comm5ts       
receiv$ by ! ,work+ ,gr\p2  7#b7 make   
recomm5dations to ! ,secret>y1 includ+ a
 propos$ /rategy relat$ to developm5t ( 
!rapeutics & vacc9es1 reg>d+ any        
appropriate *anges or improvem5ts to su*
 activities describ$ 9 p>agraph 7#a72 & 
7#c7 9 implem5t+ ?is subsection1 solicit
 input f ,/ates1 localities1 &          
nongov]nm5tal entities1 includ+         
organizations repres5t+ pati5ts1 heal?  
c>e provid]s1 rese>*]s1 & indu/ry reg>d+
 sci5tific advances1 rese>* que/ions1 & 
surveillance activities4  7c7 ,memb]%ip 
,! memb]s ( ! ,work+ ,gr\p %all repres5t
 a div]sity ( sci5tific discipl9es &    
views & %all be compos$ ( ! foll[+      
memb]s3 7#a7 ,f$]al memb]s ,sev5 ,f$]al 
memb]s1 consi/+ ( "o or m repres5tatives
 ( ea* ( ! foll[+3 7,a7 ,! ,(fice ( !   
,assi/ant ,secret>y = ,heal?4  7,b7 ,!  
,food & ,drug ,adm9i/ration4  7,c7 ,!   
,c5t]s = ,disease ,control & ,prev5tion4

  7,d7 ,! ,national ,in/itutes ( ,heal?4
  7,e7 ,su* o!r ag5cies & (fices ( !    
,dep>tm5t ( ,heal? & ,human ,s]vices z !
 ,secret>y det]m9es appropriate4  7#b7  
,non-,f$]al public memb]s ,sev5         
non-,f$]al public memb]s1 consi/+ (     
repres5tatives ( ! foll[+ categories3   
7,a7 ,physicians & o!r m$ical provid]s )
 exp]i5ce 9 diagnos+ & treat+ endemic   
fungal disease4  7,b7 ,sci5ti/s or      
rese>*]s ) exp]tise4  7,c7 ,pati5ts & _!
 family memb]s4  7,d7 ,nonpr(it         
organizations t advocate = pati5ts )    
respect to endemic fungal disease4  7,e7
 ,o!r individuals ^: exp]tise is det]m9$
 by ! ,secret>y to be b5eficial to !    
function+ ( ! ,work+ ,gr\p4  7d7 ,meet+s
 ,! ,work+ ,gr\p %all meet annually4    
7e7 ,report+ ,n lat] ?an #b ye>s aft] ! 
date ( enactm5t ( ?is ,act1 & e #b ye>s 
!reaft] until t]m9ation ( ! ,work+ ,gr\p
 pursuant to subsection 7g71 ! ,work+   
,gr\p %all-- 7#a7 submit a report on its
 activities "u subsection 7b77#a7 & any 
recomm5dations "u p>agraph 7b77#b7 to ! 

,secret>y1 ! ,committee on ,en]gy &     
,comm]ce ( ! ,h\se ( ,repres5tatives1 & 
! ,committee on ,heal?1 ,education1     
,labor1 & ,p5sions ( ! ,s5ate2 &  7#b7  
make su* report publicly available on ! 
website ( ! ,dep>tm5t ( ,heal? & ,human 
,s]vices4  7f7 ,applicability ( ,,faca  
,! ,work+ ,gr\p %all be treat$ z an     
advisory committee subject to ! ,f$]al  
,advisory ,committee ,act 7#e ,u4,s4,c4 
,app474  7g7 ,sunset ,! ,work+ ,gr\p "u 
?is section %all t]m9ate #e ye>s aft] ! 
date ( enactm5t ( ?is ,act4  7h7        
,endemic fungal disease def9$ ,9 ?is    
section1 ! t]m endemic fungal disease   
means bla/omycosis1 coccidioidomycosis1 
hi/oplasmosis1 & sp>otri*osis4  #d4     
,,fda guidance = indu/ry on developm5t (
 diagno/ics & antifungal drugs & vacc9es
 = ,valley ,fev]  7a7 ,draft guidance ,n
 lat] ?an #b ye>s aft] ! date ( enactm5t
 ( ?is ,act1 ! ,secret>y ( ,heal? &     
,human ,s]vices1 act+ ?r\gh !           
,commission] ( ,food & ,drugs1 %all     
issue draft guidance = indu/ry = !      

purposes ( assi/+ entities seek+        
approval "u ! ,f$]al ,food1 ,drug1 &    
,cosmetic ,act 7#ba ,u4,s4,c4 #cja et   
seq47 or lic5sure "u section #cea ( !   
,public ,heal? ,s]vice ,act 7#db        
,u4,s4,c4 #bfb7 ( antifungal !rapies1   
diagno/ics1 or vacc9es1 specifically    
!rapies1 diagno/ics1 & vacc9es design$  
to diagnose1 treat1 or prev5t           
coccidioidomycosis 7commonly kn[n z     
,valley ,fev]74  7b7 ,f9al guidance ,n  
lat] ?an #ah mon?s aft] ! close ( !     
public comm5t p]iod on ! draft guidance 
issu$ pursuant to subsection 7a71 !     
,secret>y ( ,heal? & ,human ,s]vices1   
act+ ?r\gh ! ,commission] ( ,food &     
,drugs1 %all f9alize ! draft guidance4  
7c7 ,work%ops2 good guidance practices  
,9 develop+ & issu+ ! guidance requir$  
by ?is section1 ! ,secret>y ( ,heal? &  
,human ,s]vices %all hold at lea/ #b    
public work%ops4  #e4 ,priority review2 
fa/ track product  7a7 ,priority review 
7#a7 ,9 g5]al ,section #ebd;,a7a7 ( !   
,f$]al ,food1 ,drug1 & ,cosmetic ,act   

7#ba ,u4,s4,c4 #cfjn-#a7;a77 is am5d$ by
 /rik+ !n ! ,secret>y %all give priority
 review to ! fir/ application submitt$ =
 approval = su* drug "u section #eje7;b7
 & ins]t+ or if ! drug is a biological  
product int5d$ to treat                 
coccidioidomycosis1 !n ! ,secret>y %all 
give priority review to ! fir/          
application submitt$ = approval = su*   
drug "u section #eje7;b7 ( ?is ,act or  
section #cea7;a7 ( ! ,public ,heal?     
,s]vice ,act4  7#b7 ,applicability ,!   
am5dm5t made by p>agraph 7#a7 applies   
only to any application submitt$ "u     
section #cea7;a7 ( ! ,public ,heal?     
,s]vice ,act 7#db ,u4,s4,c4 #bfb7;a77 on
 or aft] ! date ( enactm5t ( ?is ,act4  
7b7 ,fa/ track product ,section         
#ejf7;b77#a7 ( ! ,f$]al ,food1 ,drug1 & 
,cosmetic ,act 7#ba ,u4,s4,c4           
#cef7;b77#a77 is am5d$ by /rik+ or if ! 
,secret>y designates ! drug z a qualifi$
 infecti\s disease product "u section   
#eje;,e7d7 & ins]t+ 1 if ! ,secret>y    
designates ! drug z a qualifi$ infecti\s

 disease product "u section #eje;,e7d71 
or if ! drug is a biological product    
int5d$ to treat coccidioidomycosis4  #f4
 ,priority review v\*]s = products =    
prev5tion or treatm5t ( endemic fungal  
diseases ,section #ebd7;a77#c7 ( !      
,f$]al ,food1 ,drug1 & ,cosmetic ,act   
7#ba ,u4,s4,c4 #cfjn7a77#c77 is am5d$-- 
7#a7 by r$esignat+ subp>agraph 7,s7 z   
subp>agraph 7,t72 &  7#b7 by ins]t+ aft]
 subp>agraph 7,r7 ! foll[+3  7,s7       
,coccidioidomycosis4  4  #g4 ,combat+   
antimicrobial resi/ance bioph>maceutical
 accel]ator program ,p>agraph 7#d7 (    
section #cai,l7c7 ( ! ,public ,heal?    
,s]vice ,act 7#db ,u4,s4,c4             
#bdg;d-#g;e7c77 is am5d$ by add+ at !   
end ! foll[+3  7,g7 ,combat+            
antimicrobial resi/ance bioph>maceutical
 accel]ator program  7i7 ,9 g5]al ,!    
,secret>y1 act+ ?r\gh ! ,director (     
,,b>da1 %all implem5t /rategic          
initiatives1 to be kn[n z ! ,combat+    
,antimicrobial ,resi/ance               
,bioph>maceutical ,accel]ator ,program1 

includ+ by build+ on exi/+ programs & by
 aw>d+ contracts1 grants1 & coop]ative  
agreem5ts1 or ent]+ into o!r            
transactions-- 7,i7 to optimize ! use ( 
antimicrobials 9 human & animal heal?   
sett+s2  7,,ii7 to support innovative   
c&idate products 9 precl9ical & cl9ical 
developm5t t r$uce antimicrobial        
resi/ance2 &  7,,iii7 to support rese>* 
) respect to infection prev5tion &      
control to sl[ ! spread ( resi/ant      
bact]ia1 fungi1 & viruses4  7ii7        
,ref]5ces ,except z o!rwise specifi$1   
any ref]5ce to ! ,combat+ ,antibiotic   
,resi/ant ,bact]ia ,bioph>maceutical    
,accel]ator or ! ,,c>b-,x program 9 any 
/atute1 ,executive ord]1 rule1          
regulation1 directive1 or o!r ,f$]al    
docum5t is deem$ to be a ref]5ce to !   
,combat+ ,antimicrobial ,resi/ance      
,bioph>maceutical ,accel]ator ,program  
"u ?is subp>agraph4  7iii7 ,au?orization
 ( appropriations  7,i7 ,9 g5]al ,to    
c>ry out ! program "u clause 7i71 !re is
 au?oriz$ to be appropriat$ #ejj1jjj1jjj

 = ! p]iod ( fiscal ye>s #bjbb ?r\gh    
#bjbf1 to rema9 available until exp5d$4 
7,,ii7 ,requirem5t ,( ! am\nts made     
available to c>ry out ! program "u      
clause 7i7 = ! p]iod ( fiscal ye>s #bjbb
 ?r\gh #bjbf1 n less ?an #aj p]c5t %all 
be us$ to support antifungal product    
developm5t4  4