,,ii  #aafth ,,congress  #ast ,session  
,s4 #aefg  ,,in ,,the ,,senate ,,of     
,,the ,,united ,,states  ,may #ba1      
#bjai,ms4 ,mc,sally 7for herself and    
,ms4 ,sinema7 introduced the following  
bill2 which was read twice and referred 
to the ,committee on ,health1           
,education1 ,labor1 and ,pensions  ,a   
,,bill  ,to support endemic fungal      
disease research1 incentivize fungal    
vaccine development1 discover new       
antifungal therapies and diagnostics1   
and for other purposes4  #a4 ,short     
title2 table of contents  7a7 ,in       
general ,this ,act may be cited as the  
,finding ,orphan-disease ,remedies ,with
 ,antifungal ,research and ,development 
,act of #bjai or the ,,forward ,act of  
#bjai4  7b7 ,table of contents ,the     
table of contents for this ,act is as   
follows3 ,sec4 #a4 ,short title2 table  
of contents4,sec4 #b4 ,continuing       
support for research on endemic fungal  
diseases4,sec4 #c4 ,endemic fungal      
disease ,federal-,state match pilot     

program4,sec4 #d4 ,,fda guidance for    
industry on development of diagnostics  
and antifungal drugs and vaccines for   
,valley ,fever4,sec4 #e4 ,priority      
review2 fast track product4,sec4 #f4    
,priority review vouchers for products  
for prevention or treatment of endemic  
fungal diseases4,sec4 #g4 ,establishment
 of antifungal resistance research      
program modeled on the ,,carb-,x        
program4,sec4 #h4 ,blockchain pilot     
program for hospital data security for  
endemic fungal disease research4  #b4   
,continuing support for research on     
endemic fungal diseases ,the ,public    
,health ,service ,act is amended by     
inserting after section #cbj;,a of such 
,act 7#db ,u4,s4,c4 #bdg;d-#h7 the      
following new section3  #cbj;,b4        
,endemic fungal diseases  7a7 ,in       
general ,the ,secretary shall continue  
to conduct or support epidemiological1  
basic1 translational1 and clinical      
research related to endemic fungal      
diseases1 including coccidioidomycosis  

7commonly known as and referred to in   
this section as ,valley ,fever74  7b7   
,reports ,the ,secretary shall ensure   
that each triennial report under section
 #djc includes information on actions   
undertaken by the ,national ,institutes 
of ,health to carry out subsection 7a7  
with respect to endemic fungal diseases1
 including ,valley ,fever4  7c7 ,endemic
 ,fungal ,disease ,working ,group  7#a7 
,establishment ,the ,secretary shall    
establish a working group1 to be known  
as the ,endemic ,fungal ,disease        
,working ,group 7referred to in this    
section as the ,working ,group71        
comprised of representatives of         
appropriate ,federal agencies and other 
non-,federal entities-- 7,a7 to provide 
expertise and to review all efforts     
within the ,department of ,health and   
,human ,services related to endemic     
fungal disease2  7,b7 to help ensure    
interagency coordination and minimize   
overlap with respect to such disease2   
and  7,c7 to examine research priorities

 with respect to such disease4  7#b7    
,responsibilities ,the ,working ,group  
shall-- 7,a7 not later than #b years    
after the date of enactment of the      
,,forward ,act of #bjai1 develop or     
update a summary of-- 7i7 ongoing       
endemic fungal disease research1        
including research related to causes1   
prevention1 treatment1 surveillance1    
diagnosis1 diagnostics1 duration of     
illness1 and intervention for           
individuals with an endemic fungal      
disease2  7ii7 advances made pursuant to
 such research2  7iii7 ,federal         
activities related to endemic fungal    
disease1 including-- 7,i7               
epidemiological activities related to   
endemic fungal disease2 and  7,,ii7     
basic1 clinical1 and translational      
endemic fungal disease research related 
to the pathogenesis1 prevention1        
diagnosis1 and treatment of endemic     
fungal disease2  7iv7 gaps in endemic   
fungal disease research described in    
clause 7iii77,,ii72  7v7 the ,working   

,group's meetings required under        
paragraph 7#d72 and  7vi7 the comments  
received by the ,working ,group2  7,b7  
make recommendations to the ,secretary  
regarding any appropriate changes or    
improvements to such activities and     
research2 and  7,c7 solicit input from  
,states1 localities1 and nongovernmental
 entities1 including organizations      
representing patients1 health care      
providers1 researchers1 and industry    
regarding scientific advances1 research 
questions1 and surveillance activities4 
7#c7 ,membership ,the members of the    
,working ,group shall represent a       
diversity of scientific disciplines and 
views and shall be composed of the      
following members3 7,a7 ,federal members
 ,seven ,federal members1 consisting of 
one or more representatives of each of  
the following3 7i7 ,the ,office of the  
,assistant ,secretary for ,health4  7ii7
 ,the ,food and ,drug ,administration4  
7iii7 ,the ,centers for ,disease        
,control and ,prevention4  7iv7 ,the    

,national ,institutes of ,health4  7v7  
,such other agencies and offices of the 
,department of ,health and ,human       
,services as the ,secretary determines  
appropriate4  7,b7 ,non-,federal public 
members ,seven non-,federal public      
members1 consisting of representatives  
of the following categories3 7i7        
,physicians and other medical providers 
with experience in diagnosing and       
treating endemic fungal disease4  7ii7  
,scientists or researchers with         
expertise4  7iii7 ,patients and their   
family members4  7iv7 ,nonprofit        
organizations that advocate for patients
 with respect to endemic fungal disease4
  7v7 ,other individuals whose expertise
 is determined by the ,secretary to be  
beneficial to the functioning of the    
,working ,group4  7#d7 ,meetings ,the   
,working ,group shall meet annually4    
7#e7 ,reporting ,not later than #b years
 after the date of enactment of the     
,,forward ,act of #bjai1 and every #b   
years thereafter until termination of   

the ,working ,group pursuant to         
paragraph 7#g71 the ,working ,group     
shall-- 7,a7 submit a report on its     
activities under paragraph 7#b77;,a7 and
 any recommendations under paragraph    
7#b77;,b7 to the ,secretary1 the        
,committee on ,energy and ,commerce of  
the ,house of ,representatives1 and the 
,committee on ,health1 ,education1      
,labor1 and ,pensions of the ,senate2   
and  7,b7 make such report publicly     
available on the internet website of the
 ,department of ,health and ,human      
,services4  7#f7 ,applicability of      
,,faca ,the ,working ,group shall be    
treated as an advisory committee subject
 to the ,federal ,advisory ,committee   
,act 7#e ,u4,s4,c4 ,app474  7#g7 ,sunset
 ,the ,working ,group under this section
 shall terminate #e years after the date
 of enactment of the ,,forward ,act of  
#bjai4  7d7 ,endemic fungal disease     
defined ,in this section1 the term      
endemic fungal disease means            
blastomycosis1 coccidioidomycosis1      

histoplasmosis1 and sparotrichosis4  4  
#c4 ,endemic fungal disease             
,federal-,state match pilot program  7a7
 ,in general  7#a7 ,grants ,for each of 
fiscal years #bjba through #bjbe1 the   
,secretary of ,health and ,human        
,services shall1 subject to the         
availability of appropriations1 award   
grants through a competitive process to 
eligible entities to conduct research   
with respect to endemic fungal diseases1
 including coccidioidomycosis4  7#b7    
,peer review ,any research supported    
under this section shall be subject to  
peer review in accordance with the      
requirements applicable to research     
supported by the ,national ,institutes  
of ,health under section #dib of the    
,public ,health ,service ,act 7#db      
,u4,s4,c4 #bhi;a74  7b7 ,eligibility ,an
 entity eligible to receive a grant     
under this section is a ,state or local 
public hospital1 an institution of      
higher education 7as defined in section 
#aja of the ,higher ,education ,act of  

#aife 7#bj ,u4,s4,c4 #ajja771 a public  
health department1 or a nonprofit       
organization that has been provided     
funds from ,state or local government   
sources for epidemiological1 basic1     
translational1 and clinical research on 
endemic fungal diseases4  7c7           
,application ,an entity seeking a grant 
under this section shall submit an      
application to the ,secretary-- 7#a7 in 
such form and manner as the ,secretary  
shall prescribe2  7#b7 that contains a  
certification that the entity has       
received the funds described in         
subsection 7b7 and that specifies the   
amount of such funds2 and  7#c7 that    
contains such other information as the  
,secretary may require4  7d7 ,amount of 
grant ,the amount of a grant under this 
section shall equal 7to the extent      
practicable7 the amount of funds        
received from ,state or local government
 sources for the research that is the   
subject of the grant4  7e7 ,endemic     
fungal disease defined ,in this section1

 the term endemic fungal disease means  
blastomycosis1 coccidioidomycosis1      
histoplasmosis1 and sporotrichosis4  7f7
 ,authorization of appropriations ,there
 is authorized to be appropriated to    
carry out this section #h1jjj1jjj for   
each of fiscal years #bjba through      
#bjbe1 to remain available until        
expended4  7g7 ,sunset ,the ,secretary  
may not award grants under this section 
on or after ,october #a1 #bjbe4  #d4    
,,fda guidance for industry on          
development of diagnostics and          
antifungal drugs and vaccines for       
,valley ,fever  7a7 ,draft guidance ,not
 later than #b years after the date of  
the enactment of this ,act1 the         
,secretary of ,health and ,human        
,services1 acting through the           
,commissioner of ,food and ,drugs1 shall
 issue draft guidance for industry for  
the purposes of assisting entities      
seeking approval under the ,federal     
,food1 ,drug1 and ,cosmetic ,act 7#ba   
,u4,s4,c4 #cja et seq47 or licensure    

under section #cea of the ,public       
,health ,service ,act 7#db ,u4,s4,c4    
#bfb7 of antifungal therapies1          
diagnostics1 or vaccines1 specifically  
therapies1 diagnostics1 and vaccines    
designed to diagnose1 treat1 or prevent 
coccidioidomycosis 7commonly known as   
,valley ,fever74  7b7 ,final guidance   
,not later than #ah months after the    
close of the public comment period on   
the draft guidance issued pursuant to   
subsection 7a71 the ,secretary of       
,health and ,human ,services1 acting    
through the ,commissioner of ,food and  
,drugs1 shall finalize the draft        
guidance4  7c7 ,workshops2 good guidance
 practices ,in developing and issuing   
the guidance required by this section1  
the ,secretary of ,health and ,human    
,services shall hold at least #b public 
workshops4  #e4 ,priority review2 fast  
track product  7a7 ,priority review     
7#a7 ,in general ,section #ebd;,a7a7 of 
the ,federal ,food1 ,drug1 and ,cosmetic
 ,act 7#ba ,u4,s4,c4 #cfjn-#a7;a77 is   

amended by striking then the ,secretary 
shall give priority review to the first 
application submitted for approval for  
such drug under section #eje7;b7 and    
inserting or if the drug is a biological
 product intended to treat              
blastomycosis1 coccidioidomycosis1      
histoplasmosis1 or sporotrichosis1 then 
the ,secretary shall give priority      
review to the first application         
submitted for approval for such drug    
under section #eje7;b7 of this ,act or  
section #cea7;a7 of the ,public ,health 
,service ,act4  7#b7 ,applicability ,the
 amendment made by paragraph 7#a7       
applies to an application submitted     
under section #cea7;a7 of the ,public   
,health ,service ,act 7#db ,u4,s4,c4    
#bfb7;a77 only if such application is   
submitted on or after the date of       
enactment of this ,act4  7b7 ,fast track
 product ,section #ejf7;b77#a7 of the   
,federal ,food1 ,drug1 and ,cosmetic    
,act 7#ba ,u4,s4,c4 #cef7;b77#a77 is    
amended by striking or if the ,secretary

 designates the drug as a qualified     
infectious disease product under section
 #eje;,e7d7 and inserting 1 if the      
,secretary designates the drug as a     
qualified infectious disease product    
under section #eje;,e7d71 or if the drug
 is a biological product intended to    
treat blastomycosis1 coccidioidomycosis1
 histoplasmosis1 or sporotrichosis4  #f4
 ,priority review vouchers for products 
for prevention or treatment of endemic  
fungal diseases ,section #ebd7;a77#c7 of
 the ,federal ,food1 ,drug1 and         
,cosmetic ,act 7#ba ,u4,s4,c4           
#cfjn7a77#c77 is amended-- 7#a7 by      
redesignating subparagraph 7,s7 as      
subparagraph 7,t72 and  7#b7 by         
inserting after subparagraph 7,r7 the   
following3  7,s7 ,blastomycosis1        
coccidioidomycosis1 histoplasmosis1 and 
sporotrichosis4  4  #g4 ,establishment  
of antifungal resistance research       
program modeled on the ,,carb-,x program
  7a7 ,in general ,the ,secretary of    
,health and ,human ,services1 acting    

through the ,director of the ,biomedical
 ,advanced ,research and ,development   
,authority1 shall carry out a program1  
modeled on the ,combating ,antibiotic   
,resistant ,bacteria ,accelerator       
program of the ,department of ,health   
and ,human ,services 7commonly referred 
to as ,,carb-,x71 for research with     
respect to antifungal resistance1       
including therapies1 diagnostics1 and   
vaccines1 including for                 
coccidioidomycosis4  7b7 ,authorization 
of appropriations ,there is authorized  
to be appropriated to carry out         
subsection 7a7 #aj1jjj1jjj for each of  
fiscal years #bjba through #bjbe1 to    
remain available until expended4  #h4   
,blockchain pilot program for hospital  
data security for endemic fungal disease
 research ,part ,a of title ,,iv of the 
,public ,health ,service ,act 7#db      
,u4,s4,c4 #bha et seq47 is amended by   
adding at the end the following new     
section3  #djd,o4 ,blockchain pilot     
program for hospital data security for  

endemic fungal disease research  7a7 ,in
 general ,the ,director of ,,nih shall  
carry out a pilot program to conduct1   
support1 and facilitate auditable       
research on endemic fungal disease4 ,in 
carrying out such program1 the ,director
 of ,,nih shall-- 7#a7 award a grant to 
an eligible entity to install a         
blockchain on the servers of1 or        
otherwise provide blockchain services   
to1 the ,national ,institutes of        
,health1 and provide support with       
respect to such a blockchain1 which     
shall contain public1 unalterable data  
which includes every query made through 
the procedure established under         
subsection 7c71 as well as the identity 
of the individual who asked such a      
question1 without disclosing the results
 of such queries2  7#b7 award a grant to
 an eligible entity-- 7,a7 to provide to
 not less than #c qualified hospitals   
qualified software2 and  7,b7 to provide
 customer service to each such hospital 
with respect to such qualified software 

or any associated service2  7#c7 provide
 to such qualified hospitals any        
necessary hardware in accordance with   
subsection 7e72 and  7#d7 award grants  
to eligible entities to test the        
cybersecurity of such qualified         
hospitals by attempting to attack       
simulated data on the servers of such   
hospitals4  7b7 ,eligible entities2     
application ,the ,director of ,,nih     
shall determine whether an entity is    
eligible to receive a grant under this  
section and shall select hospitals to be
 qualified hospitals for purposes of    
this section4 ,an entity seeking a grant
 under this section1 and a hospital     
seeking to be so selected1 shall submit 
to the ,director of ,,nih an application
 in such form and manner and containing 
such information as the ,director of    
,,nih may specify4  7c7 ,data queries   
,the ,director of ,,nih shall establish1
 for purposes of allowing researchers to
 process data from a qualified          
hospital's servers pursuant to this     

section1 a procedure to determine-- 7#a7
 who can ask queries of the servers2    
7#b7 which data the hospital must       
include on such servers2 and  7#c7 which
 questions may be asked of such servers1
 and what form of de-identification of  
the servers' data is required to ensure 
privacy4  7d7 ,request for proposals    
,not later than #ij days after the date 
of the enactment of this section1 the   
,director of ,,nih shall publish in the 
,federal ,register a request for        
proposals for grants under paragraphs   
7#a71 7#b71 and 7#d7 of subsection 7a74 
7e7 ,provision of servers  7#a7 ,in     
general ,the ,director of ,,nih shall1  
in carrying out subsection 7a77#c71     
provide to qualified hospitals hardware1
 including computer servers1 sufficient 
to support qualified software4  7#b7    
,condition ,as a condition on the       
receipt of a computer server under      
paragraph 7#a71 a qualified hospital    
shall agree not to use the qualified    
software on the server to store data    

from patients of the hospital until the 
,director of ,,nih determines that      
testing performed pursuant to subsection
 7a77#d7 has determined that simulated  
data used in such software could not be 
extracted from the hospital's servers4  
7f7 ,definitions ,in this section3 7#a7 
,the term blockchain means software that
 uses a distributed digital ledger of   
cryptographically signed transactions   
that are grouped into blocks1 each of   
which-- 7,a7 is cryptographically linked
 to the previous block after validation 
and undergoing a consensus decision2 and
  7,b7 when added as a new block1 makes 
any older blocks more difficult to      
modify and is replicated across all     
copies of the ledger within the relevant
 network1 with any conflicts in such    
blocks resolved automatically using     
established rules4  7#b7 ,the term      
endemic fungal disease means            
blastomycosis1 coccidioidomycosis1      
histoplasmosis1 and sporotrichosis4     
7#c7 ,the term qualified hospital means 

a hospital that is located in a region  
in which endemic fungal disease is      
endemic4  7#d7 ,the term qualified      
software means software that uses secure
 multiparty encrypted computing to allow
 researchers to perform computations on 
encrypted data supplied by qualified    
hospitals4  7#e7 ,the term secure       
multiparty encrypted computing means a  
form of cryptography in which parties   
can jointly compute a function of inputs
 while keeping those inputs private from
 each other1 and from all other parties1
 such as multiparty homomorphic         
encryption1 threshold encryption1 and   
secure multiparty computation4  7g7     
,authorization of appropriations ,there 
is authorized to be appropriated to     
carry out this section #e1jjj1jjj for   
fiscal year #bjba1 to remain available  
until expended4  4