,i  #aah? ,,congress  #b;d ,session  ,h4
 ,r4 #iidb  ,,9 ,,! ,,h\se ,,(          
,,repres5tatives  ,octob] #h1 #bjbd,mr4 
,du>te 7= himself1 ,mr4 ,/anton1 ,mr4   
,s*weik]t1 ,mr4 ,co/a1 ,mr4 ,valadao1   
,ms4 ,tokuda1 & ,mr4 ,ob]nolte7         
introduc$ ! foll[+ bill2 :i* 0 ref]r$ to
 ! ,committee on ,en]gy & ,comm]ce  ,a  
,,bill  ,to support ! developm5t1       
lic5s+1 & initial manufactur+ ( a human 
vacc9e = valley fev]4  #a4 ,%ort title  
,?is ,act may be cit$ z ! ,valley ,fev] 
,aw>5ess & ,vacc9e ,developm5t &        
,manufactur+ ,act ( #bjbd4  #b4 ,valley 
fev] vacc9e national /rategy  7a7 ,:ole 
( gov]nm5t approa*  7#a7 ,9 g5]al ,!    
,secret>y %all coord9ate ) ! relevant   
ag5cy heads to support ! developm5t1    
lic5s+1 & initial manufactur+ ( a human 
vacc9e = valley fev]4  7#b7             
,consultation ,9 implem5t+ p>agraph     
7#a71 ! ,secret>y %all consult ) exp]t  
/akehold]s on valley fev] & vacc9e      
developm5t & manufactur+4  7#c7 ,vacc9e 
,coord9ator  7,a7 ,appo9tm5t ,n lat] ?an

 #fj days aft] ! date ( ! enactm5t ( ?is
 section1 ! ,secret>y %all appo9t a     
,vacc9e ,coord9ator f among ! (ficials  
at ! ,food & ,drug ,adm9i/ration or !   
,national ,in/itutes ( ,heal?4  7,b7    
,duties ,! ,vacc9e ,coord9ator %all--   
7i7 act z a s+le po9t ( contact )9 !    
,f$]al ,gov]nm5t on matt]s relat$ to    
implem5t+ ?is section2  7ii7 n lat] #ahj
 days aft] ! date ( ! enactm5t ( ?is    
section1 & e #ahj days !reaft]1 publi%  
on ! int]net website ( ! ,dep>tm5t (    
,heal? & ,human ,s]vices a report t     
describes all ( ! activities und]tak5   
pursuant to ?is section2  7iii7 n lat]  
?an six mon?s aft] ! date ( ! enactm5t (
 ?is section1 & e six mon?s !reaft]1    
conv5e a meet+ ) ! relevant ag5cy heads 
& exp]t /akehold]s to advance !         
developm5t1 approval1 & manufactur+ ( a 
valley fev] vacc9e2 &  7iv7 id5tify ways
 to-- 7,i7 exp$ite regulatory review &  
lic5s+ ( a safe & effective valley fev] 
vacc9e1 consi/5t ) applicable safety &  
o!r requirem5ts2 &  7,,ii7 to advance ! 

developm5t1 lic5s+1 & manufactur+ ( su* 
a vacc9e4  7b7 ,valley ,fev] vacc9e     
developm5t national /rategy  7#a7 ,9    
g5]al ,n lat] ?an "o ye> aft] ! date ( !
 enactm5t ( ?is section1 ! ,secret>y1   
act+ ?r\gh ! ,vacc9e ,coord9ator & 9    
consultation ) ! relevant ag5cy heads & 
exp]t /akehold]s1 %all develop & publi% 
on ! int]net website ( ! ,dep>tm5t (    
,heal? & ,human ,s]vices a national     
/rategy to develop1 lic5se1 &           
manufacture a valley fev] vacc9e by no  
lat] ?an ,janu>y #a1 #bjcd4  7#b7       
,cont5t ,! national /rategy %all        
conta9-- 7,a7 a /atem5t ( sci5ce on     
valley fev]1 includ+ curr5t ef=ts to    
develop a valley fev] vacc9e2  7,b7 an  
assessm5t ( ! /atus ( valley fev] vacc9e
 developm5t & manufactur+1 includ+      
vacc9e m>ket viability2  7,c7 an ov]view
 ( ,f$]al rese>* fund+ made available   
ov] ! #aj ye>s prec$+ ! date ( !        
enactm5t ( ?is section to support valley
 fev] vacc9e developm5t1 includ+        
pre-cl9ical & cl9ical "w1 lic5s+1 &     

manufactur+2  7,d7 id5tifiable &        
a*ievable b5*m>ks = vacc9e developm5t & 
manufactur+1 includ+ a timel9e = valley 
fev] vacc9e developm5t & manufactur+    
consi/5t ) ! timel9e 9 p>agraph 7#a72   
7,e7 ,f$]al1 ,/ate1 & local fund+       
priorities & opportunities t actively   
support ! developm5t or manufactur+ ( a 
valley fev] vacc9e2  7,f7 recomm5dations
 = coord9ation betwe5 ,f$]al ag5cies &  
dep>tm5ts to r$uce any ov]lap ) respect 
to valley fev] vacc9e developm5t &      
manufactur+ reviews1 p]mits1 & lic5s+2  
7,g7 recomm5dations on actions ,f$]al   
ag5cies & dep>tm5ts may take to exp$ite 
! developm5t or manufactur+ ( a valley  
fev] vacc9e t d n require congressional 
au?orization2  7,h7 recomm5dations on   
actions t ,congress may take to exp$ite 
! developm5t & manufactur+ ( a valley   
fev] vacc9e2 &  7,i7 an assessm5t (--   
7i7 ! preval5ce ( valley fev] 9 ! ,unit$
 ,/ates2  7ii7 ! co/ associat$ ) treat+ 
valley fev] 9 ! ,unit$ ,/ates2 &  7iii7 
! economic impact ( valley fev] 9 !     

,unit$ ,/ates4  7#c7 ,public comm5t     
7,a7 ,9 g5]al ,n lat] ?an six mon?s aft]
 ! date ( ! enactm5t ( ?is section1 !   
,secret>y %all publi% a propos$ draft ( 
! national /rategy 9 ! ,f$]al ,regi/] & 
provide an opportunity = public comm5t  
on su* national /rategy4  7,b7          
,consid]ation ( comm5ts ,9 f9aliz+ !    
national /rategy1 ! ,secret>y %all      
consid] public comm5ts receiv$ pursuant 
to subp>agraph 7,a74  7#d7 ,exp]t       
consultation ,9 develop+ ! national     
/rategy1 ! ,secret>y1 act+ ?r\gh !      
,vacc9e ,coord9ator1 %all-- 7,a7 consult
 ) ! relevant ag5cy heads & exp]t       
/akehold]s2 &  7,b7 hold n less ?an two 
9-p]son meet+s ) ! relevant ag5cy heads 
& exp]t /akehold]s1 ( :i* "o %all be    
conduct$ prior to receiv+ public comm5ts
 on ! national /rategy & "o %all be     
conduct$ aft] su* public comm5ts are    
receiv$4  #c4 ,guidance on developm5t1  
manufactur+1 & approval ( valley fev]   
vacc9e ,! ,director ( ! ,national       
,in/itutes ( ,heal?1 ! ,commission] (   

,food & ,drugs1 & ! ,director ( ! ,c5t]s
 = ,disease ,control & ,prev5tion %all  
issue guidance on ! developm5t &        
manufactur+ ( a valley fev] vacc9e &    
approval = use ( su* vacc9e1 z          
applicable4  #d4 ,vacc9e developm5t &   
manufactur+  7a7 ,vacc9e developm5t     
program  7#a7 ,9 g5]al ,! ,secret>y1    
act+ ?r\gh ! ,vacc9e ,coord9ator & 9    
consultation ) ! relevant ag5cy heads1  
%all c>ry out a program (-- 7,a7 ent]+  
into contracts ) eligible entities to   
support & advance ! developm5t ( a      
valley fev] vacc9e2 or  7,b7 aw>d+      
grants to eligible entities "u p>agraph 
7#b74  7#b7 ,grant program  7,a7 ,9     
g5]al ,! ,secret>y may aw>d grants      
pursuant to p>agraph 7#a77;,b7 to       
support & advance ! developm5t ( a      
valley fev] vacc9e4  7,b7 ,priority ,9  
aw>d+ grants "u subp>agraph 7,a71 !     
,secret>y %all give priority to         
applicants t h comm5c$ ,phase #a1 #b1 or
 #c cl9ical trials on a valley fev]     
vacc9e4  7,c7 ,aw>d am\nt ,! am\nt ( a  

grant "u ?is p>agraph %all be n less ?an
 #ejj1jjj & n m ?an #b1ejj1jjj4  7#c7   
,comm5cem5t ,n lat] ?an #ahj days aft] !
 date ( ! enactm5t ( ?is section1 !     
,secret>y %all comm5ce ! program "u     
p>agraph 7#a74  7#d7 ,consultation      
requirem5t ,9 c>ry+ out ?is subsection1 
! ,secret>y %all consult ) physicians1  
m$ical provid]s1 sci5ti/s1 rese>*]s1    
nonpr(it entities1 advocacy gr\ps1 & o!r
 individuals ) exp]tise 9 valley fev]   
rese>* & vacc9e developm5t4  7b7 ,vacc9e
 manufactur+ program  7#a7 ,9 g5]al ,!  
,secret>y1 act+ ?r\gh ! ,vacc9e         
,coord9ator & 9 consultation ) !        
relevant ag5cy heads1 %all-- 7,a7 ent]  
into contracts ) eligible entities to   
support & advance ! manufactur+ ( a     
valley fev] vacc9e2 or  7,b7 aw>d grants
 to eligible entities "u p>agraph 7#b74 
7#b7 ,grant program  7,a7 ,9 g5]al ,!   
,secret>y may aw>d grants pursuant to   
p>agraph 7#a77;,b7 to support & advance 
! manufactur+ ( a valley fev] vacc9e4   
7,b7 ,aw>d am\nt ,! am\nt ( a grant "u  

?is p>agraph %all be n less ?an #ejj1jjj
 & n m ?an #e1jjj1jjj4  7#c7 ,comm5cem5t
 ,n lat] ?an #ahj days aft] ! date ( !  
enactm5t ( ?is section1 ! ,secret>y %all
 comm5ce ! programs "u p>agraph 7#a74   
7#d7 ,consultation requirem5t ,9 c>ry+  
out ?is subsection1 ! ,secret>y %all    
consult ) vacc9e manufactur+ exp]ts &   
o!r individuals ) exp]tise 9 valley fev]
 rese>* & vacc9e manufactur+4  #e4      
,au?orization ( appropriations ,!re are 
au?oriz$ to be appropriat$ to !         
,secret>y-- 7#a7 #a1jjj1jjj = fiscal ye>
 #bjbf to c>ry out section #b7;b72  7#b7
 #be1jjj1jjj = ! p]iod ( fiscal ye>s    
#bjbe ?r\gh #bjcj to c>ry out section   
#d7;a72 &  7#c7 #be1jjj1jjj = ! p]iod ( 
fiscal ye>s #bjbe ?r\gh #bjcj to c>ry   
out section #d7;b74  #f4 ,national      
,valley ,fev] ,regi/ry ,"p ,p ( title   
,,iii ( ! ,public ,heal? ,s]vice ,act   
7#db ,u4,s4,c4 #bhj;g et seq47 is am5d$ 
by add+ at ! end ! foll[+3  #cii,v-#h4  
,national ,valley ,fev] ,regi/ry  7a7   
,data collection & regi/ry  7#a7 ,9     

g5]al ,! ,secret>y1 act+ ?r\gh !        
,director ( ! ,c5t]s = ,disease ,control
 & ,prev5tion1 if sci5tifically         
advisable1 may-- 7,a7 c>ry out a sy/em  
to collect non-p]sonally id5tifiable    
volunt>y data on coccidioidomycosis     
7ref]r$ to 9 ?is section z valley fev]7 
& o!r fungal diseases t c be confus$ )  
valley fev] or misdiagnos$ z valley     
fev]1 includ+ in=mation ) respect to !  
incid5ce & preval5ce ( su* diseases 9 ! 
,unit$ ,/ates2 &  7,b7 ma9ta9 a national
 regi/ry 7ref]r$ to 9 ?is section z !   
,national ,valley ,fev] ,regi/ry7 = !   
collection & /orage ( ! data collect$   
pursuant to subp>agraph 7,a7 to develop 
a population-bas$ regi/ry ( cases 9 !   
,unit$ ,/ates ( valley fev] & o!r fungal
 diseases t c be confus$ ) valley fev]  
or misdiagnos$ z valley fev]4  7#b7     
,requir$ comm5cem5t tim+ ,! au?ority to 
comm5ce activities "u p>agraph 7#a7 %all
 t]m9ate on ! date t is "o ye> aft] !   
receipt ( ! report describ$ 9 subsection
 7b77#d74  7b7 ,advisory committee  7#a7

 ,e/abli%m5t ,n lat] ?an #ahj days aft] 
! date ( ! enactm5t ( ?is section1 !    
,secret>y1 act+ ?r\gh ! ,director ( !   
,c5t]s = ,disease ,control & ,prev5tion1
 %all e/abli% ! ,advisory ,committee on 
! ,national ,valley ,fev] ,regi/ry      
7ref]r$ to 9 ?is section z ! #8,advisory
 ,committee'74  7#b7 ,memb]%ip ,!       
,advisory ,committee %all be compos$ ( n
 m ?an #bg memb]s to be appo9t$ by !    
,secret>y1 act+ ?r\gh ! ,director (     
,c5t]s = ,disease ,control & ,prev5tion1
 ( :i*-- 7,a7 two-?irds ( ! memb]s ( !  
,advisory ,committee %all repres5t      
,f$]al ag5cies1 includ+ at lea/-- 7i7   
two memb]s repres5t+ ! ,national        
,in/itutes ( ,heal?1 to include1 ^u !   
recomm5dation ( ! ,director ( !         
,national ,in/itutes ( ,heal?1 "o su*   
memb] repres5t+ ! ,national ,in/itute ( 
,all]gy & ,infecti\s ,diseases2  7ii7 "o
 memb] repres5t+ ! ,dep>tm5t ( ,def5se2 
7iii7 "o memb] repres5t+ ! ,c5t]s =     
,disease ,control & ,prev5tion2  7iv7 "o
 memb] :o is a cl9ician ) exp]tise on   

valley fev] & relat$ diseases2  7v7 "o  
memb] :o is an epidemiologi/ ) exp]i5ce 
9 data regi/ries2  7vi7 "o memb] :o is a
 /ati/ician2  7vii7 "o memb] :o is an   
e?ici/2 &  7viii7 "o memb] :o is an     
exp]t 9 privacy regulations "u ! ,heal? 
,insurance ,portability & ,acc\ntability
 ,act ( #aiif 7#db ,u4,s4,c4            
#acbj;d-#f72 &  7,b7 "o-?ird ( ! memb]s 
( ! ,advisory ,committee %all be memb]s 
( ! public1 includ+ at lea/-- 7i7 "o    
memb] repres5t+ national & volunt>y     
heal? associations2  7ii7 "o memb]      
repres5t+ pati5ts ) valley fev] or _!   
family memb]s2  7iii7 "o memb] repres5t+
 cl9icians ) exp]tise on valley fev] &  
relat$ diseases2  7iv7 "o memb]         
repres5t+ epidemiologi/s ) exp]tise 9   
data regi/ries2 &  7v7 "o memb]         
repres5t+ individuals ) an int]e/ 9     
develop+ & ma9ta9+ ! ,national ,valley  
,fev] ,regi/ry4  7#c7 ,duties ,!        
,advisory ,committee %all-- 7,a7 review 
in=mation & make recomm5dations to !    
,secret>y conc]n+-- 7i7 ! developm5t &  

ma9t5ance ( ! ,national ,valley ,fev]   
,regi/ry2  7ii7 ! type ( in=mation to be
 collect$ & /or$ 9 ! ,national ,valley  
,fev] ,regi/ry2  7iii7 ! mann] 9 :i* su*
 data is to be collect$2  7iv7 ! use &  
availability ( su* data includ+         
guidel9es = su* use2 &  7v7 ! collection
 ( in=mation ab\t diseases & disord]s t 
prim>ily affect motor neurons t are     
consid]$ ess5tial to fur!r+ ! /udy &    
cure ( valley fev]2 &  7,b7 ov]see !    
,national ,valley ,fev] ,regi/ry1 if !  
,secret>y e/abli%es ! ,national ,valley 
,fev] ,regi/ry4  7#d7 ,report ,n lat]   
?an #bgj days aft] ! date on :i* !      
,advisory ,committee is e/abli%$1 !     
,advisory ,committee %all submit a      
report to ! ,secret>y conta9+ !         
in=mation review$ & ea* recomm5dation   
made "u p>agraph 7#c77;,a74  7#e7       
,t]m9ation ,! ,advisory ,committee %all 
t]m9ate on ! date t is sev5 ye>s aft] ! 
date on :i* ! report requir$ "u p>agraph
 7#d7 is submitt$4  7c7 ,grants  7#a7 ,9
 g5]al ,! ,secret>y1 act+ ?r\gh !       

,director ( ! ,c5t]s = ,disease ,control
 & ,prev5tion1 may aw>d grants to1 &    
ent] into contracts & coop]ative        
agreem5ts )1 public or private nonpr(it 
entities = ! collection1 analysis1 &    
report+ ( data on valley fev] & o!r     
fungal diseases t c be confus$ ) valley 
fev] or misdiagnos$ z valley fev]4  7#b7
 ,comm5cem5t ,aft] receiv+ ! report "u  
subsection 7b77#d71 ! ,secret>y may     
comm5ce mak+ aw>ds "u p>agraph 7#a74    
7d7 ,coord9ation ) ,f$]al1 ,/ate1 &     
local regi/ries  7#a7 ,9 g5]al ,9       
e/abli%+ ! ,national ,valley ,fev]      
,regi/ry1 ! ,secret>y1 act+ ?r\gh !     
,director ( ! ,c5t]s = ,disease ,control
 & ,prev5tion1 may-- 7,a7 id5tify1 build
 ^u1 exp&1 & coord9ate among exi/+ data1
 surveys1 regi/ries1 & o!r ,f$]al public
 heal? & environm5tal infra/ructure     
:]ev] possible1 :i* may include-- 7i7   
any regi/ry previ\sly support$ by !     
,c5t]s = ,disease ,control & ,prev5tion2
  7ii7 ,/ate-bas$ valley fev] regi/ries2
  7iii7 ! ,national ,vital ,/ati/ics    

,sy/em ( ! ,national ,c5t] = ,heal?     
,/ati/ics2 &  7iv7 any o!r exi/+ or     
relevant databases t collect or ma9ta9  
in=mation on ea* fungal disease         
recomm5d$ by ! ,advisory ,committee2 &  
7,b7 provide = rese>* access to valley  
fev] data1 z recomm5d$ by ! ,advisory   
,committee1 to ! ext5t p]mitt$ by       
applicable /atutes & regulations & 9 a  
mann] t protects privacy consi/5t )     
applicable privacy /atutes &            
regulations4  7#b7 ,coord9ation ) !     
,national ,in/itutes ( ,heal? ,consi/5t 
) applicable privacy /atutes &          
regulations1 ! ,secret>y may ensure t   
epidemiological & o!r types ( in=mation 
obta9$ "u subsection 7a7 is made        
available to ! ,director ( ! ,national  
,in/itutes ( ,heal?4  7e7 ,national &   
volunt>y heal? associations def9$ ,9 ?is
 section1 ! t]m national & volunt>y     
heal? associations means a national     
nonpr(it organization ) *apt]s or o!r   
affiliat$ organizations 9 ,/ates ?r\gh\t
 ! ,unit$ ,/ates t h-- 7#a7 exp]i5ce    

s]v+ ! population ( individuals ) valley
 fev]2 &  7#b7 h demon/rat$ exp]i5ce 9  
valley fev] rese>*1 c>e1 & pati5t       
s]vices4  4  #g4 ,def9itions ,9 ?is     
,act-- 7#a7 ! t]m eligible entity       
means-- 7,a7 an academic in/itution2    
7,b7 a nonpr(it organization2  7,c7 a   
,/ate or local gov]nm5t2 &  7,d7 a      
private entity2  7#b7 ! t]m exp]t       
/akehold]s means academic in/itutions1  
advocacy gr\ps1 cl9icians1 pati5t gr\ps1
 rese>*]s1 public heal? (ficials1       
sci5ti/s1 & vacc9e manufactures )       
exp]tise 9 valley fev]1 vacc9e          
developm5t1 or vacc9e manufactur+2  7#c7
 ! t]m relevant ag5cy heads means-- 7,a7
 ! ,director ( ! ,national ,in/itutes ( 
,heal?2  7,b7 ! ,director ( ! ,biom$ical
 ,advanc$ ,rese>* & ,developm5t         
,au?ority2  7,c7 ! ,commission] ( ,food 
& ,drugs2 &  7,d7 su* o!r heads ( ,f$]al
 ag5cies & dep>tm5ts z ! ,secret>y      
det]m9es relevant2  7#d7 ! t]m ,secret>y
 means ! ,secret>y ( ,heal? & ,human    
,s]vices2  7#e7 ! t]m valley fev] means 

coccidioidomycosis2 &  7#f7 ! t]m       
,vacc9e ,coord9ator means ! valley fev] 
vacc9e developm5t coord9ator appo9t$ "u 
section #b7;a77#c74