,,ii  #aahth ,,congress  #ast ,session  
,s4 #cdfd  ,,in ,,the ,,senate ,,of     
,,the ,,united ,,states  ,december #ab1 
#bjbc,mr4 ,kelly 7for himself 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 #bjbc or the       
,,forward ,act of #bjbc4  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 working         
group4,sec4 #d4 ,expanding tropical     

disease product priority review voucher 
program to encourage prevention and     
treatment of coccidioidomycosis4,sec4   
#e4 ,combating antimicrobial resistance 
biopharmaceutical accelerator program4  
#b4 ,continuing support for research on 
endemic fungal diseases ,the ,public    
,health ,service ,act is amended by     
inserting after section #ddg;,d of such 
,act 7#db ,u4,s4,c4 #bhe;f-#e7 the      
following new section3  #ddg;,e4        
,endemic fungal diseases  7a7 ,in       
general ,the ,director of the ,institute
 shall-- 7#a7 continue to conduct or    
support basic1 translational1 and       
clinical research related to fungal     
diseases found in the ,united ,states1  
including coccidioidomycosis 7commonly  
known as and referred to in this section
 as ,valley ,fever72 and  7#b7 subject  
to the availability of appropriations1  
make grants to1 or enter into contracts 
with1 public or nonprofit private       
entities to conduct such research4  7b7 
,reports ,the ,director of the          

,institute 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 such fungal diseases1   
including coccidioidomycosis4  7c7      
,authorization of appropriations ,in    
addition to other amounts available for 
the purposes of carrying out this       
section1 there is authorized to be      
appropriated to carry out this section  
#bj1jjj1jjj for each of fiscal years    
#bjbd through #bjbh for such purpose4  4
  #c4 ,endemic fungal disease working   
group  7a7 ,establishment ,the          
,secretary of ,health and ,human        
,services 7referred to in this section  
as the ,secretary7 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 fungal disease in  
the ,united ,states2  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
  7b7 ,duties ,the ,working ,group      
shall-- 7#a7 make recommendations to the
 ,secretary1 including an updated       
strategy related to development of      
therapeutics and vaccines for endemic   
fungal diseases1 that shall-- 7,a7 take 
into account ongoing fungal disease     
research1 including for animals1 that   
may be adapted for human use2  7,b7     
identify gaps in endemic fungal disease 
research1 including basic1 clinical1 and
 translational research related to the  
pathogenesis1 prevention1 diagnosis1 and
 treatment of such diseases2 and  7,c7  
include recommendations for             
congressional action to spur additional 

research and product development for    
fungal diseases2 and  7#b7 in           
implementing this subsection1 solicit   
input from ,states1 ,tribes1 localities1
 and nongovernmental entities1 including
 organizations representing patients1   
health care providers1 researchers1 and 
industry regarding scientific advances1 
research questions1 and surveillance    
activities4  7c7 ,membership ,the       
members of the ,working ,group shall    
represent a diversity of scientific     
disciplines 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 7,a7 ,the ,office of the     
,assistant ,secretary for ,health1 who  
shall serve as ,chair4  7,b7 ,the ,food 
and ,drug ,administration4  7,c7 ,the   
,centers for ,disease ,control and      
,prevention4  7,d7 ,the ,national       
,institutes of ,health1 who shall serve 
as ,vice ,chair4  7,e7 ,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 7,a7 ,physicians1           
veterinarians1 and other medical        
providers with experience in diagnosing 
and treating endemic fungal disease4    
7,b7 ,scientists or researchers with    
expertise in endemic fungal disease4    
7,c7 ,patients who have been diagnosed  
with an endemic fungal disease and      
family members or caregivers of such    
patients1 as applicable4  7,d7          
,nonprofit organizations that advocate  
for patients with respect to endemic    
fungal disease4  7,e7 ,other individuals
 whose expertise is determined by the   
,secretary to be beneficial to the      
functioning of the ,working ,group4  7d7
 ,meetings ,the ,working ,group shall   
meet not less frequently than annually4 
7e7 ,reporting ,not later than #a year  

after the date of enactment of this     
,act1 and annually thereafter until     
termination of the ,working ,group      
pursuant to subsection 7g71 the         
,secretary shall-- 7#a7 submit a report 
on recommendations received under       
subsection 7b77#a7 to the ,committee on 
,health1 ,education1 ,labor1 and        
,pensions of the ,senate and the        
,committee on ,energy and ,commerce of  
the ,house of ,representatives2 and     
7#b7 make such report publicly available
 on the website of the ,department of   
,health and ,human ,services4  7f7      
,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  7g7 ,sunset ,the ,working      
,group under this section shall         
terminate #e years after the date of    
enactment of this ,act4  7h7 ,endemic   
fungal disease defined ,in this section1
 the term endemic fungal disease means  
blastomycosis1 coccidioidomycosis1      

histoplasmosis1 and sparotrichosis4  #d4
 ,expanding tropical disease product    
priority review voucher program to      
encourage prevention and treatment of   
coccidioidomycosis ,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 ,coccidioidomycosis4  4
  #e4 ,combating antimicrobial          
resistance biopharmaceutical accelerator
 program ,paragraph 7#d7 of section     
#cai,l7c7 of the ,public ,health        
,service ,act 7#db ,u4,s4,c4            
#bdg;d-#g;e7c77 is amended by adding at 
the end the following3  7,h7 ,combating 
antimicrobial resistance                
biopharmaceutical accelerator program   
7i7 ,in general ,the ,secretary1 acting 
through the ,director of ,,barda1 shall 
implement strategic initiatives1 to be  
known as the ,combating ,antimicrobial  

,resistance ,biopharmaceutical          
,accelerator ,program1 including by     
building on existing programs and by    
awarding contracts1 grants1 and         
cooperative agreements1 or entering into
 other transactions-- 7,i7 to optimize  
the use of antimicrobials in human      
health settings2  7,,ii7 to support     
innovative candidate products in        
preclinical and clinical development    
that reduce antimicrobial resistance2   
and  7,,iii7 to support research with   
respect to infection prevention and     
control to slow the spread of resistant 
bacteria1 fungi1 and viruses4  7ii7     
,references ,except as otherwise        
specified1 any reference to the         
,combating ,antibiotic ,resistant       
,bacteria ,biopharmaceutical            
,accelerator or the ,,carb-,x program in
 any statute1 ,executive order1 rule1   
regulation1 directive1 or other ,federal
 document is deemed to be a reference to
 the ,combating ,antimicrobial          
,resistance ,biopharmaceutical          

,accelerator ,program under this        
subparagraph4  7iii7 ,authorization of  
appropriations  7,i7 ,in general ,to    
carry out the program under clause 7i71 
there is authorized to be appropriated  
#ejj1jjj1jjj for the period of fiscal   
years #bjbd through #bjbh1 to remain    
available until expended4  7,,ii7       
,requirement ,of the amounts made       
available to carry out the program under
 clause 7i7 for the period of fiscal    
years #bjbd through #bjbh1 not less than
 #bj percent shall be used to support   
antifungal product development4  4