,i  #aae? ,,congress  #b;d ,session  ,h4
 ,r4 #fefb  ,,9 ,,! ,,h\se ,,(          
,,repres5tatives  ,july #bf1 #bjah,mr4  
,mc,carthy 7= himself1 ,mr4 ,s*weik]t1  
,ms4 ,bass1 ,ms4 ,s9ema1 & ,ms4         
,mc,sally7 introduc$ ! foll[+ bill2 :i* 
0 ref]r$ to ! ,committee on ,en]gy &    
,comm]ce  ,a ,,bill  ,to support endemic
 orphan fungal disease rese>*1          
inc5tivize ,valley ,fev] vacc9e         
developm5t1 discov] new antifungal      
!rapies & diagno/ics1 & = o!r purposes4 
#a4 ,%ort title2 table ( cont5ts  7a7 ,9
 g5]al ,?is ,act may be cit$ z ! ,f9d+  
,orphan-disease ,rem$ies ,) ,antifungal 
,rese>* & ,developm5t ,act ( #bjah or ! 
,,=w>d ,act ( #bjah4  7b7 ,table (      
cont5ts ,! table ( cont5ts = ?is ,act is
 z foll[s3  ,sec4 #a4 ,%ort title2 table
 ( cont5ts4 ,sec4 #b4 ,f9d+s4 ,sec4 #c4 
,cont9u+ support = rese>* on endemic    
orphan fungal diseases4 ,sec4 #d4       
,endemic orphan fungal disease          
,f$]al-,/ate mat* pilot program4 ,sec4  
#e4 ,,fda guidance = indu/ry on         

developm5t ( diagno/ics & antifungal    
drugs & vacc9es = ,valley ,fev]4 ,sec4  
#f4 ,includ+ antifungal biological      
products z qualifi$ infecti\s disease   
products4 ,sec4 #g4 ,priority review to 
enc\rage treatm5ts = endemic orphan     
fungal diseases4 ,sec4 #h4 ,includ+     
antifungal products 9 ! ,,c>b-,x        
program4 ,sec4 #i4 ,block*a9 pilot      
program = hospital data security =      
coccidioidomycosis rese>*4  #b4 ,f9d+s  
,congress f9ds ! foll[+3 7#a7 ,worldwide
 fungal infections1 su* z c&idiasis1    
cryptococcosis1 & asp]gillosis1 (t5 pose
 fatal opportuni/ic ?reats to           
immunologically impair$ p]sons4  7#b7   
,endemic fungal infections1 su* z       
hi/oplasmosis1 coccidioidomycosis1 &    
bla/omycosis1 occur 9 c]ta9 geographic  
regions worldwide1 includ+ 9 ! ,unit$   
,/ates1 & are acquir$ ?r\gh exposure to 
! environm5t4  7#c7 ,because ! endemic  
mycoses ref]r$ to 9 p>agraph 7#b7 are   
regional1 su* endemic mycoses d n       
receive ! same am\nt ( res\rces z       

mycoses ( worldwide di/ribution1 ev5    
?\gh )9 ! regions 9 :i* !y are endemic  
su* /ra9s pose significant public heal? 
?reats4  7#d7 ,coccidioidomycosis1 also 
kn[n z ,valley ,fev]1 is a fungal       
infection acquir$ by ! inhalation (     
spores ( c]ta9 fungi prim>ily f\nd 9 !  
soil endemic to ! ,am]ican ,s\?we/1     
includ+ 9 ,arizona1 ,cali=nia1 ,nevada1 
,new ,mexico1 ,texas1 ,utah1 & ,wa%+ton4
  7#e7 ,accord+ to ! ,morbidity &       
,mortality ,weekly ,report issu$ by !   
,c5t]s = ,disease ,control & ,prev5tion 
& dat$ ,augu/ #aa1 #bjag--  7,a7 #ig    
p]c5t ( ! all report$ cases ( ,valley   
,fev] occurr$ 9 ,cali=nia & ,arizona2   
7,b7 individuals at increas$ risk =     
sev]e ,valley ,fev] include p]sons (    
,african or ,filip9o desc5t1 pregnant   
wom51 adults 9 old] age gr\ps1 & o!r    
individuals ) weak5$ immune sy/ems2     
7,c7 ! ov]all incid5t rate ( ,valley    
,fev] peak$ 9 #bjaa & aga9 9 #bjaf2     
7,d7 9 ,cali=nia1 ! ,valley ,fev]       
incid5t rate = #bjaf 0 ! highe/ record$ 

to date1 ) #db p]c5t ( cases report$    
com+ f ,k]n ,c\nty2 &  7,e7 ! reason =  
increases 9 ,valley ,fev] cases report$ 
9 ,cali=nia 9 #bjaf is n kn[n4  7#f7    
,valley ,fev] illness ranges f          
influ5za-l symptoms to life-?reat5+ :5 !
 infection spreads to o!r p>ts ( ! body1
 includ+ ! bra94  7#g7 ,! ov]all e/imat$
 impact ( ,valley ,fev] is less ?an     
#bjj1jjj p 9 ! ,unit$ ,/ates1 ) r\ghly  
#bjj dea?s ea* ye> & ov] #aa1jjj new    
cases id5tifi$ 9 #bjaf4 ,! e/imat$      
economic impact to ! ,unit$ ,/ates is at
 lea/ #ejj1jjj1jjj f hospital1          
outpati5t1 & lo/ productivity co/s4     
7#h7 ,9 ! pa/ #fj ye>s1 only #d classes 
( antifungal comp\nds h be5 approv$ by !
 ,food & ,drug ,adm9i/ration = treatm5t 
= all fungal infections4  7#i7 ,exi/+   
antifungal !rapies (t5 d n cure ! fungal
 infection involv$ because1 simil> to h[
 bact]ia h become resi/ant to antibiotic
 !rapies1 "s fungi no long] respond to !
 curr5t limit$ antifungal !rapies t are 
design$ to treat !m4  7#aj7             

,coccidioides1 ! cause ( ,valley ,fev]1 
is n cur$ by any available drug4  7#aa7 
,al?\gh antibiotic-resi/ant bact]ial    
infections are a widely recogniz$ public
 heal? ?reat1 less is kn[n ab\t !       
effects ( antifungal resi/ance & ! burd5
 ( drug-resi/ant fungal infections4     
7#ab7 ,fungal infections are a ris+     
?reat to public heal? & ! resi/ance to  
curr5t antifungal !rapies w only        
complicate ! ,nation's response 9 ! ev5t
 ( a public heal? em]g5cy4  #c4 ,cont9u+
 support = rese>* on endemic orphan     
fungal diseases  7a7 ,9 g5]al ,subtitle 
,f ( title ,,ii ( ! #ba/ ,c5tury ,cures 
,act 7,public ,law #aad-bee7 is am5d$ by
 ins]t+ aft] section #bjfb 7#db         
,u4,s4,c4 #bhds7 ! foll[+ new section3  
#bjfb;,a4 ,endemic orphan fungal        
diseases  7a7 ,9 g5]al ,! ,secret>y (   
,heal? & ,human ,s]vices 79 ?is section 
ref]r$ to z ! ,secret>y7 %all cont9ue to
 conduct or support epidemiological1    
basic1 translational1 & cl9ical rese>*  
relat$ to endemic orphan fungal         

diseases1 includ+ coccidioidomycosis    
7commonly kn[n z & ref]r$ to 9 ?is      
section z ,valley ,fev]74  7b7 ,reports 
,! ,secret>y %all ensure t ea* tri5nial 
report "u section #djc ( ! ,public      
,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bhc7
 includes in=mation on actions und]tak5 
by ! ,national ,in/itutes ( ,heal? to   
c>ry out subsection 7a7 ) respect to    
endemic orphan fungal diseases1 includ+ 
,valley ,fev]4  7c7 ,valley ,fev] ,work+
 ,gr\p  7#a7 ,e/abli%m5t ,! ,secret>y   
%all e/abli% a work+ gr\p1 to be kn[n z 
! ,valley ,fev] ,work+ ,gr\p 7ref]r$ to 
9 ?is section z ! ,work+ ,gr\p71        
compris$ ( repres5tatives ( appropriate 
,f$]al ag5cies & o!r non-,f$]al         
entities1 to provide exp]tise & to      
review all ef=ts )9 ! ,dep>tm5t ( ,heal?
 & ,human ,s]vices relat$ to ,valley    
,fev]1 to help ensure int]ag5cy         
coord9ation & m9imize ov]lap1 & to      
exam9e rese>* priorities4  7#b7         
,responsibilities ,! ,work+ ,gr\p %all--
 7,a7 n lat] ?an #b ye>s aft] ! date (  

enactm5t ( ?is ,act1 develop or update a
 summ>y (--  7i7 ongo+ ,valley ,fev]    
rese>*1 includ+ rese>* relat$ to causes1
 prev5tion1 treatm5t1 surveillance1     
diagnosis1 diagno/ics1 duration (       
illness1 & int]v5tion = individuals )   
,valley ,fev]2  7ii7 advances made      
pursuant to su* rese>*2  7iii7 ,f$]al   
activities relat$ to ,valley ,fev]1     
includ+--  7,i7 epidemiological         
activities relat$ to ,valley ,fev]2 &   
7,,ii7 basic1 cl9ical1 & translational  
,valley ,fev] rese>* relat$ to !        
pa?og5esis1 prev5tion1 diagnosis1 &     
treatm5t ( ,valley ,fev]2  7iv7 gaps 9  
,valley ,fev] rese>* describ$ 9 clause  
7iii77,,ii72  7v7 ! ,work+ ,gr\p's      
meet+s requir$ "u p>agraph 7#d72 &  7vi7
 ! comm5ts receiv$ by ! ,work+ ,gr\p2   
7,b7 make recomm5dations to ! ,secret>y 
reg>d+ any appropriate *anges or        
improvem5ts to su* activities & rese>*2 
&  7,c7 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    
7#c7 ,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  
7i7 ,! ,(fice ( ! ,assi/ant ,secret>y = 
,heal?4  7ii7 ,! ,food & ,drug          
,adm9i/ration4  7iii7 ,! ,c5t]s =       
,disease ,control & ,prev5tion4  7iv7 ,!
 ,national ,in/itutes ( ,heal?4  7v7    
,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 7i7 ,physicians & o!r
 m$ical provid]s ) exp]i5ce 9 diagnos+ &
 treat+ ,valley ,fev]4  7ii7 ,sci5ti/s  
or rese>*]s ) exp]tise4  7iii7 ,pati5ts 
& _! family memb]s4  7iv7 ,nonpr(it     
organizations t advocate = pati5ts )    

respect to ,valley ,fev]4  7v7 ,o!r     
individuals ^: exp]tise is det]m9$ by ! 
,secret>y to be b5eficial to ! function+
 ( ! ,work+ ,gr\p4  7#d7 ,meet+s ,!     
,work+ ,gr\p %all meet annually4  7#e7  
,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 p>agraph 7#g71 ! ,work+    
,gr\p %all--  7,a7 submit a report on   
its activities "u p>agraph 7#b77;,a7 &  
any recomm5dations "u p>agraph 7#b77;,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 ! 
int]net website ( ! ,dep>tm5t ( ,heal? &
 ,human ,s]vices4  7#f7 ,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  7#g7 ,sunset ,!      
,work+ ,gr\p "u ?is section %all t]m9ate
 #e ye>s aft] ! date ( enactm5t ( ?is   

,act4  7d7 ,endemic orphan fungal       
disease def9$ ,! t]m endemic orphan     
fungal disease has ! mean+ giv5 su* t]m 
9 section #ebi;,b7a7 ( ! ,f$]al ,food1  
,drug1 & ,cosmetic ,act4  4  7b7 ,con=m+
 table ( cont5ts am5dm5t ,section #a7;b7
 ( ! #ba/ ,c5tury ,cures ,act 7,public  
,law #aad-bee7 is am5d$ 9 ! table (     
cont5ts1 by ins]t+ aft] ! item relat+ to
 section #bjfb ! foll[+3  ,sec4         
#bjfb;,a4 ,endemic orphan fungal        
diseases4  4  #d4 ,endemic orphan fungal
 disease ,f$]al-,/ate mat* pilot program
  7a7 ,9 g5]al ,= ea* ( fiscal ye>s     
#bjai ?r\gh #bjbd1 ! ,secret>y ( ,heal? 
& ,human ,s]vices %all1 subject to !    
availability ( appropriations1 aw>d     
grants ?r\gh a competitive process to   
eligible entities to conduct rese>* )   
respect to endemic orphan fungal        
diseases1 includ+ coccidioidomycosis4   
7b7 ,eligibility ,an entity eligible to 
receive a grant "u ?is section is a     
,/ate or local public hospital1 an      
in/itution ( high] education 7z def9$ 9 

section #aja ( ! ,high] ,education ,act 
( #aife 7#bj ,u4,s4,c4 #ajja771 or a    
nonpr(it organization t has be5 provid$ 
funds f ,/ate or local gov]nm5t s\rces =
 epidemiological1 basic1 translational1 
& cl9ical rese>* on endemic orphan      
fungal diseases dur+ ! #c-ye> p]iod end+
 on ! date ( ! enactm5t ( ?is ,act4  7c7
 ,application ,an entity seek+ a grant  
"u ?is section %all submit an           
application to ! ,secret>y-- 7#a7 9 su* 
=m & mann] z ! ,secret>y %all prescribe2
  7#b7 t conta9s a c]tification t !     
entity has receiv$ ! funds describ$ 9   
subsection 7b7 & t specifies ! am\nt (  
su* funds2 &  7#c7 t conta9s su* o!r    
in=mation z ! ,secret>y may require4    
7d7 ,am\nt ( grant ,! am\nt ( a grant "u
 ?is section %all equal 7to ! ext5t     
practicable7 ! am\nt ( funds receiv$ f  
,/ate or local gov]nm5t s\rces = !      
rese>* t is ! subject ( ! grant4  7e7   
,endemic orphan fungal disease def9$ ,! 
t]m endemic orphan fungal disease has ! 
mean+ giv5 su* t]m 9 section #ebi;,b ( !

 ,f$]al ,food1 ,drug1 & ,cosmetic ,act1 
z add$ by section #g4  7f7 ,au?orization
 ( appropriations ,!re are au?oriz$ to  
be appropriat$ to c>ry out ?is section  
#h1jjj1jjj = ea* ( fiscal ye>s #bjai    
?r\gh #bjbd1 to rema9 available until   
exp5d$4  7g7 ,sunset ,! ,secret>y may n 
aw>d grants "u ?is section on or aft]   
,octob] #a1 #bjbd4  #e4 ,,fda guidance =
 indu/ry on developm5t ( diagno/ics &   
antifungal drugs & vacc9es = ,valley    
,fev]  7a7 ,9 g5]al ,n lat] ?an "o ye>  
aft] ! date ( ! enactm5t ( ?is ,act1 !  
,secret>y ( ,heal? & ,human ,s]vices1   
act+ ?r\gh ! ,commission] ( ,food &     
,drugs1 %all issue draft guidance =     
indu/ry = ! purposes ( assi/+ entities  
seek+ approval "u ! ,f$]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 ,consultation ,9   
develop+ ! draft guidance "u subsection 
7a71 ! ,secret>y ( ,heal? & ,human      
,s]vices1 act+ ?r\gh ! ,commission] (   
,food & ,drugs1 %all consult )          
in/itutions ( high] education 7z def9$ 9
 section #aja ( ! ,high] ,education ,act
 ( #aife 7#bj ,u4,s4,c4 #ajja771        
rese>*]s1 & o!r relevant /akehold]s4    
7c7 ,f9al guidance ,! ,secret>y ( ,heal?
 & ,human ,s]vices1 act+ ?r\gh !        
,commission] ( ,food & ,drugs1 %all     
f9alize ! draft guidance issu$ "u       
subsection 7a7 n lat] ?an #b ye>s aft] !
 date ( ! enactm5t ( ?is ,act4  #f4     
,includ+ antifungal biological products 
z qualifi$ infecti\s disease products   
7a7 ,9 g5]al ,section #eje;,e ( ! ,f$]al
 ,food1 ,drug1 & ,cosmetic ,act 7#ba    
,u4,s4,c4 #cee;f7 is am5d$-- 7#a7 9     
subsection 7a7--  7,a7 by ins]t+ 7or1   
pursuant to section #cea ( ! ,public    
,heal? ,s]vice ,act1 9 ! case ( an      
antifungal biological product7 aft]     

pursuant to section #eje = a drug2 &    
7,b7 by /rik+ or ! #g-ye> p]iod describ$
 9 section #ebg1 & ins]t+ ! #g-ye> p]iod
 describ$ 9 section #ebg1 or1 9 ! case (
 an antifungal biological product1 !    
#ab-ye> p]iod "u section #cea7k7 ( !    
,public ,heal? ,s]vice ,act12  7#b7 9   
subsection 7c7-- 7,a7 9 p>agraph 7#a71  
by ins]t+ or1 9 ! case ( an antifungal  
biological product1 section #cea7;a7 ( !
 ,public ,heal? ,s]vice ,act aft]       
#eje7;b72 &  7,b7 9 p>agraph 7#b71 by   
ins]t+ or1 9 ! case ( an antifungal     
biological product1 section #cea ( !    
,public ,heal? ,s]vice ,act aft] #eje2  
7#c7 9 subsection 7d77#a7 by ins]t+ or1 
9 ! case ( an antifungal biological     
product1 section #cea7;a7 ( ! ,public   
,heal? ,s]vice ,act aft] #eje7;b72 &    
7#d7 9 subsection 7g71 9 ! matt] prec$+ 
p>agraph 7#a7-- 7,a7 by ins]t+ 7includ+ 
antifungal biological products7 aft]    
antifungal drug2 &  7,b7 by ins]t+ or   
prev5t aft] treat4  7b7 ,effective date 
,! am5dm5ts made by subsection 7a7 %all 

apply ) respect to applications = !     
approval ( biological products "u       
section #cea ( ! ,public ,heal? ,s]vice 
,act 7#db ,u4,s4,c4 #bfb7 submitt$ on or
 aft] ! date ( ! enactm5t ( ?is ,act4   
7c7 ,updat$ guidance ,n lat] ?an "o ye> 
aft] ! date ( ! enactm5t ( ?is ,act1 !  
,secret>y ( ,heal? & ,human ,s]vices1   
act+ ?r\gh ! ,commission] ( ,food &     
,drugs1 %all update ,qualifi$ ,infecti\s
 ,disease ,product ,designation         
,que/ions & ,answ]s ,guidance = ,indu/ry
 issu$ 9 ,janu>y #bjah1 to implem5t !   
am5dm5ts made by subsection 7a74  #g4   
,priority review to enc\rage treatm5ts =
 endemic orphan fungal diseases         
,sub*apt] ,b ( *apt] ,v ( ! ,f$]al      
,food1 ,drug1 & ,cosmetic ,act 7#ba     
,u4,s4,c4 #cfj;aa et seq47 is am5d$ by  
add+ at ! end ! foll[+ new section3     
#ebi;,b4 ,priority review to enc\rage   
treatm5ts = endemic orphan fungal       
diseases  7a7 ,def9itions ,9 ?is        
section3 7#a7 ,endemic orphan fungal    
disease ,! t]m endemic orphan fungal    

disease means a disease1 su* z          
coccidioidomycosis1 t--  7,a7 is caus$  
by a fungus2  7,b7 prim>ily occurs 9    
c]ta9 limit$ geographic regions2 &  7,c7
 is a r>e disease or condition 7z t t]m 
is def9$ 9 section #ebf7;a77#b7 ( !     
,f$]al ,food1 ,drug1 & ,cosmetic ,act   
7#ba ,u4,s4,c4 #cfj;bb7a77#b7774  7#b7  
,endemic orphan fungal disease drug     
application ,! t]m endemic orphan fungal
 disease drug application means an      
application t-- 7,a7 is a human drug    
application = a drug int5d$ = use--  7i7
 to prev5t or treat h>m f an endemic    
orphan fungal disease2 or  7ii7 to cure 
an endemic orphan fungal disease2  7,b7 
! ,secret>y det]m9es eligible = priority
 review2  7,c7 is approv$ aft] ! date ( 
enactm5t ( ?is section2 &  7,d7 is = a  
human drug1 no active +r$i5t 7includ+   
any e/] or salt ( ! active +r$i5t7 ( :i*
 has be5 approv$ 9 any o!r application  
"u section #eje7;b77#a7 or section      
#cea7;a7 ( ! ,public ,heal? ,s]vice     
,act4  7#c7 ,human drug application ,!  

t]m human drug application has ! mean+  
giv5 su* t]m 9 section #gce7a74  7#d7   
,priority review ,! t]m priority review1
 ) respect to a human drug application1 
means review & action by ! ,secret>y on 
su* application n lat] ?an #f mon?s aft]
 receipt by ! ,secret>y ( su*           
application1 z describ$ 9 ! ,manual (   
,policies & ,proc$ures 9 ! ,food & ,drug
 ,adm9i/ration & goals id5tifi$ 9 !     
lett]s describ$ 9 section #aja7;b7 ( !  
,food & ,drug ,adm9i/ration ,safety &   
,innovation ,act4  7#e7 ,priority review
 v\*] ,! t]m priority review v\*] means 
a v\*] issu$ by ! ,secret>y to ! sponsor
 ( an endemic orphan fungal disease drug
 application t entitles ! hold] ( su*   
v\*] to priority review ( a s+le human  
drug application submitt$ "u section    
#eje7;b77#a7 or section #cea7;a7 ( !    
,public ,heal? ,s]vice ,act aft] ! date 
( approval ( ! endemic orphan fungal    
disease drug application4  7b7 ,priority
 ,review ,v\*]  7#a7 ,9 g5]al ,!        
,secret>y %all aw>d a priority review   

v\*] to ! sponsor ( an endemic orphan   
fungal disease drug application ^u      
approval by ! ,secret>y ( su* endemic   
orphan fungal disease drug application4 
7#b7 ,transf]ability ,! sponsor ( a     
endemic orphan fungal disease drug      
application t receives a priority review
 v\*] "u ?is section may transf]        
7includ+ by sale7 ! entitlem5t to su*   
v\*] to a sponsor ( a human drug = :i*  
an application "u section #eje7;b77#a7  
or section #cea7;a7 ( ! ,public ,heal?  
,s]vice ,act w be submitt$ aft] ! date (
 ! approval ( ! endemic orphan fungal   
disease drug application4 ,!re is no    
limit on ! numb] ( times a priority     
review v\*] may be transf]r$ be=e su*   
v\*] is us$4  7#c7 ,notification  7,a7  
,9 g5]al ,! sponsor ( a human drug      
application %all notify ! ,secret>y n   
lat] ?an #ij cal5d> days prior to       
submission ( ! human drug application t 
is ! subject ( a priority review v\*] ( 
an int5t to submit ! human drug         
application1 includ+ ! date on :i* !    

sponsor int5ds to submit ! application4 
,su* notification %all be a legally b9d+
 commitm5t to pay = ! us] fee to be     
assess$ 9 accordance ) ?is section4     
7,b7 ,transf] aft] notice ,! sponsor ( a
 human drug application t provides      
notification ( ! int5t ( su* sponsor to 
use ! v\*] = ! human drug application "u
 subp>agraph 7,a7 may transf] ! v\*]    
aft] su* notification is provid$1 if su*
 sponsor has n yet submitt$ ! human drug
 application describ$ 9 ! notification4 
7c7 ,priority ,review ,us] ,fee  7#a7 ,9
 g5]al ,! ,secret>y %all e/abli% a us]  
fee program "u :i* a sponsor ( a human  
drug application t is ! subject ( a     
priority review v\*] %all pay to !      
,secret>y a fee det]m9$ "u p>agraph     
7#b74 ,su* fee %all be 9 addition to any
 fee requir$ to be submitt$ by ! sponsor
 "u *apt] ,,vii4  7#b7 ,fee am\nt ,!    
am\nt ( ! priority review us] fee %all  
be det]m9$ ea* fiscal ye> by ! ,secret>y
 & bas$ on ! av]age co/ incurr$ by !    
ag5cy 9 ! review ( a human drug         

application subject to priority review 9
 ! previ\s fiscal ye>4  7#c7 ,annual fee
 sett+ ,! ,secret>y %all e/abli%1 be=e !
 beg9n+ ( ea* fiscal ye> beg9n+ aft]    
,septemb] #cj1 #bjai1 = t fiscal ye>1 ! 
am\nt ( ! priority review us] fee4  7#d7
 ,paym5t  7,a7 ,9 g5]al ,! priority     
review us] fee requir$ by ?is subsection
 %all be due ^u ! submission ( a human  
drug application "u section #eje7;b77#a7
 or section #cea7;a7 ( ! ,public ,heal? 
,s]vice ,act = :i* ! priority review    
v\*] is us$4  7,b7 ,complete application
 ,an application describ$ "u subp>agraph
 7,a7 = :i* ! sponsor reque/s ! use ( a 
priority review v\*] %all be consid]$   
incomplete if ! fee requir$ by ?is      
subsection & all o!r applicable us] fees
 are n paid 9 accordance ) ! ,secret>y's
 proc$ures = pay+ su* fees4  7,c7 ,no   
waiv]s1 exemptions1 r$uctions1 or       
refunds ,! ,secret>y may n grant a      
waiv]1 exemption1 r$uction1 or refund ( 
any fees due & payable "u ?is section4  
7#e7 ,(fsett+ collections ,fees collect$

 pursuant to ?is subsection = any fiscal
 ye>-- 7,a7 %all be deposit$ & cr$it$ z 
(fsett+ collections to ! acc\nt provid+ 
appropriations to ! ,food & ,drug       
,adm9i/ration2 &  7,b7 %all n be        
collect$ = any fiscal ye> except to !   
ext5t provid$ 9 advance 9 appropriation 
,acts4  7d7 ,notice ( ,issuance ( ,v\*] 
& ,approval ( ,products ,"u ,v\*] ,!    
,secret>y %all publi% a notice 9 !      
,f$]al ,regi/] & on ! ,int]net website (
 ! ,food & ,drug ,adm9i/ration n lat]   
?an #cj cal5d> days aft] ! occurr5ce (  
ea* ( ! foll[+3  7#a7 ,! ,secret>y      
issues a priority review v\*] "u ?is    
section4  7#b7 ,! ,secret>y approves a  
drug pursuant to an application submitt$
 "u section #eje7;b7 ( ?is ,act or      
section #cea7;a7 ( ! ,public ,heal?     
,s]vice ,act = :i* ! sponsor ( !        
application us$ a priority review v\*]  
issu$ "u ?is section4  7e7 ,eligibility 
= ,o!r ,programs ,no?+ 9 ?is section    
precludes a sponsor :o seeks a priority 
review v\*] "u ?is section f p>ticipat+ 

9 any o!r inc5tive program1 includ+ "u  
?is ,act1 except t no sponsor ( a       
mat]ial ?reat m$ical c\nt]measure       
application may receive m ?an "o        
priority review v\*] issu$ "u any       
section ( ?is ,act ) respect to su*     
drug4  7f7 ,relation to ,o!r ,provisions
 ,! provisions ( ?is section %all       
supplem5t1 n supplant1 any o!r          
provisions ( ?is ,act or ! ,public      
,heal? ,s]vice ,act t enc\rage !        
developm5t ( m$ical c\nt]measures4  7g7 
,sunset ,! ,secret>y may n aw>d any     
priority review v\*]s "u subsection 7b7 
aft] ,octob] #a1 #bjbd4  4  #h4 ,includ+
 antifungal products 9 ! ,,c>b-,x       
program  7a7 ,9 g5]al ,! ,secret>y (    
,heal? & ,human ,s]vices %all1 9 c>ry+  
out ! ,combat+ ,antibiotic ,resi/ant    
,bact]ia ,accel]ator program ( !        
,dep>tm5t ( ,heal? & ,human ,s]vices    
7commonly ref]r$ to z ,,c>b-,x71 conduct
 rese>* ) respect to antifungal         
resi/ance1 includ+ !rapies1 diagno/ics1 
& vacc9es1 includ+ = coccidioidomycosis4

  7b7 ,au?orization ( appropriations    
,!re are au?oriz$ to be appropriat$ to !
 ,biodef5se ,m$ical ,c\nt]measure       
,developm5t ,fund e/abli%$ "u section   
#cai,l7d7 ( ! ,public ,heal? ,s]vice    
,act 7#db ,u4,s4,c4 #bdg;d-#g;e7d77 to  
c>ry out subsection 7a7 #aj1jjj1jjj =   
ea* ( fiscal ye>s #bjai ?r\gh #bjbd1 to 
rema9 available until exp5d$4  #i4      
,block*a9 pilot program = hospital data 
security = coccidioidomycosis rese>* ,"p
 ,a ( title ,,iv ( ! ,public ,heal?     
,s]vice ,act 7#db ,u4,s4,c4 #bha et     
seq47 is am5d$ by add+ at ! end ! foll[+
 new section3  #djd,o4 ,block*a9 pilot  
program = hospital data security =      
coccidioidomycosis rese>*  7a7 ,9 g5]al 
,! ,director ( ,,nih %all c>ry out a    
pilot program to conduct1 support1 &    
facilitate auditable rese>* on          
coccidioidomycosis 7commonly ref]r$ to z
 ,valley ,fev]74 ,9 c>ry+ out su*       
program1 ! ,director %all--  7#a7 aw>d a
 grant to an eligible entity to in/all a
 block*a9 on ! s]v]s (1 or o!rwise      

provide block*a9 s]vices to1 ! ,national
 ,in/itutes ( ,heal?1 & provide support 
) respect to su* a block*a91 :i* %all   
conta9 public1 unalt]able data :i*      
includes e qu]y made ?r\gh ! proc$ure   
e/abli%$ "u subsection 7c71 z well z !  
id5tity ( ! individual :o ask$ su* a "q1
 )\t disclos+ ! results ( su* qu]ies2   
7#b7 aw>d a grant to an eligible        
entity-- 7,a7 to provide to n less ?an  
#c qualifi$ hospitals qualifi$ s(tw>e2 &
  7,b7 to provide cu/om] s]vice to ea*  
su* hospital ) respect to su* qualifi$  
s(tw>e or any associat$ s]vice2  7#c7   
provide to su* qualifi$ hospitals any   
necess>y h>dw>e 9 accordance )          
subsection 7e72 &  7#d7 aw>d grants to  
eligible entities to te/ ! cyb]security 
( su* qualifi$ hospitals by attempt+ to 
attack simulat$ data on ! s]v]s ( su*   
hospitals4  7b7 ,eligible entities2     
application ,! ,director ( ,,nih %all   
det]m9e :e!r an entity is eligible to   
receive a grant "u ?is section & %all   
select hospitals to be qualifi$         

hospitals = purposes ( ?is section4 ,an 
entity seek+ a grant "u ?is section1 & a
 hospital seek+ to be s select$1 %all   
submit to ! ,director ( ,,nih an        
application 9 su* =m & mann] & conta9+  
su* in=mation z ! ,director ( ,,nih may 
specify4  7c7 ,data qu]ies ,! ,director 
( ,,nih %all e/abli%1 = purposes ( all[+
 rese>*]s to process data f a qualifi$  
hospital's s]v]s pursuant to ?is        
section1 a proc$ure to det]m9e--  7#a7  
:o c ask qu]ies ( ! s]v]s2  7#b7 :i*    
data ! hospital mu/ include on su*      
s]v]s2 &  7#c7 :i* que/ions may be ask$ 
( su* s]v]s1 & :at =m ( de-id5tification
 ( ! s]v]s' data is requir$ to ensure   
privacy4  7d7 ,reque/ = proposals ,n    
lat] ?an #ij days aft] ! date ( !       
enactm5t ( ?is section1 ! ,director (   
,,nih %all publi% 9 ! ,f$]al ,regi/] a  
reque/ = proposals = grants "u p>agraphs
 7#a71 7#b71 & 7#d7 ( subsection 7a74   
7e7 ,provision ( s]v]s  7#a7 ,9 g5]al ,!
 ,director ( ,,nih %all1 9 c>ry+ out    
subsection 7a77#c71 provide to qualifi$ 

hospitals h>dw>e1 includ+ comput] s]v]s1
 suffici5t to support qualifi$ s(tw>e4  
7#b7 ,condition ,z a condition on !     
receipt ( a comput] s]v] "u p>agraph    
7#a71 a qualifi$ hospital %all agree n  
to use ! qualifi$ s(tw>e on ! s]v] to   
/ore data f pati5ts ( ! hospital until !
 ,director ( ,,nih det]m9es t te/+ p]=m$
 pursuant to subsection 7a77#d7 has     
det]m9$ t simulat$ data us$ 9 su* s(tw>e
 c\ld n be extract$ f ! hospital's      
s]v]s4  7f7 ,def9itions ,9 ?is section3 
7#a7 ,! t]m block*a9 means s(tw>e t uses
 a di/ribut$ digital l$g] (             
cryptographically sign$ transactions t  
are gr\p$ into blocks1 ea* ( :i*--  7,a7
 is cryptographically l9k$ to ! previ\s 
block aft] validation & und]go+ a       
cons5sus decision2 &  7,b7 :5 add$ z a  
new block1 makes any old] blocks m      
difficult to modify & is replicat$      
across all copies ( ! l$g] )9 ! relevant
 network1 ) any conflicts 9 su* blocks  
resolv$ automatically us+ e/abli%$      
rules4  7#b7 ,! t]m qualifi$ hospital   

means a hospital t is locat$ 9 a region 
9 :i* coccidioidomycosis is endemic4    
7#c7 ,! t]m qualifi$ s(tw>e means s(tw>e
 t uses secure multip>ty encrypt$       
comput+ to all[ rese>*]s to p]=m        
computations on encrypt$ data suppli$ by
 qualifi$ hospitals4  7#d7 ,! t]m secure
 multip>ty encrypt$ comput+ means a =m (
 cryptography 9 :i* p>ties c jo9tly     
compute a function ( inputs :ile keep+  
^? inputs private f ea* o!r1 & f all o!r
 p>ties1 su* z multip>ty homomorphic    
encryption1 ?re%old encryption1 & secure
 multip>ty computation4  7g7            
,au?orization ( appropriations ,!re are 
au?oriz$ to be appropriat$ to c>ry out  
?is section #e1jjj1jjj = fiscal ye>     
#bjbj1 to rema9 available until exp5d$4 
4