,,ii #aaf? ,,congress #a/ ,session ,s4 #aefg ,,9 ,,! ,,s5ate ,,( ,,! ,,unit$ ,,/ates ,may #ba1 #bjai,ms4 ,mc,sally 7= h]self & ,ms4 ,s9ema7 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 title2 table ( cont5ts 7a7 ,9 g5]al ,?is ,act may be cit$ z ! ,f9d+ ,orphan-disease ,rem$ies ,) ,antifungal ,rese>* & ,developm5t ,act ( #bjai or ! ,,=w>d ,act ( #bjai4 7b7 ,table ( cont5ts ,! table ( cont5ts = ?is ,act is z foll[s3 ,sec4 #a4 ,%ort title2 table ( cont5ts4,sec4 #b4 ,cont9u+ support = rese>* on endemic fungal diseases4,sec4 #c4 ,endemic fungal disease ,f$]al-,/ate mat* pilot program4,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 ,e/abli%m5t ( antifungal resi/ance rese>* program model$ on ! ,,c>b-,x program4,sec4 #h4 ,block*a9 pilot program = hospital data security = endemic fungal disease rese>*4 #b4 ,cont9u+ support = rese>* on endemic fungal diseases ,! ,public ,heal? ,s]vice ,act is am5d$ by ins]t+ aft] section #cbj;,a ( su* ,act 7#db ,u4,s4,c4 #bdg;d-#h7 ! foll[+ new section3 #cbj;,b4 ,endemic fungal diseases 7a7 ,9 g5]al ,! ,secret>y %all 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]74 7b7 ,reports ,! ,secret>y %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 ,endemic ,fungal ,disease ,work+ ,gr\p 7#a7 ,e/abli%m5t ,! ,secret>y %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 7#b7 ,responsibilities ,! ,work+ ,gr\p %all-- 7,a7 n lat] ?an #b ye>s aft] ! date ( enactm5t ( ! ,,=w>d ,act ( #bjai1 develop or update a summ>y (-- 7i7 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 7ii7 advances made pursuant to su* rese>*2 7iii7 ,f$]al activities relat$ to endemic fungal disease1 includ+-- 7,i7 epidemiological activities relat$ to endemic fungal disease2 & 7,,ii7 basic1 cl9ical1 & translational endemic fungal disease rese>* relat$ to ! pa?og5esis1 prev5tion1 diagnosis1 & treatm5t ( endemic fungal disease2 7iv7 gaps 9 endemic fungal disease 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$ical provid]s ) exp]i5ce 9 diagnos+ & treat+ endemic fungal disease4 7ii7 ,sci5ti/s or rese>*]s ) exp]tise4 7iii7 ,pati5ts & _! family memb]s4 7iv7 ,nonpr(it organizations t advocate = pati5ts ) respect to endemic fungal disease4 7v7 ,o!r individuals ^: exp]tise is det]m9$ 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 ( ! ,,=w>d ,act ( #bjai1 & 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$]al ,advisory ,committee ,act 7#e ,u4,s4,c4 ,app474 7#g7 ,sunset ,! ,work+ ,gr\p "u ?is section %all t]m9ate #e ye>s aft] ! date ( enactm5t ( ! ,,=w>d ,act ( #bjai4 7d7 ,endemic fungal disease def9$ ,9 ?is section1 ! t]m endemic fungal disease means bla/omycosis1 coccidioidomycosis1 hi/oplasmosis1 & sp>otri*osis4 4 #c4 ,endemic fungal disease ,f$]al-,/ate mat* pilot program 7a7 ,9 g5]al 7#a7 ,grants ,= ea* ( fiscal ye>s #bjba ?r\gh #bjbe1 ! ,secret>y ( ,heal? & ,human ,s]vices %all1 subject to ! availability ( appropriations1 aw>d grants ?r\gh a competitive process to eligible entities to conduct rese>* ) respect to endemic fungal diseases1 includ+ coccidioidomycosis4 7#b7 ,pe] review ,any rese>* support$ "u ?is section %all be subject to pe] review 9 accordance ) ! requirem5ts applicable to rese>* support$ by ! ,national ,in/itutes ( ,heal? "u section #dib ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bhi;a74 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 a public heal? dep>tm5t1 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 fungal diseases4 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 fungal disease def9$ ,9 ?is section1 ! t]m endemic fungal disease means bla/omycosis1 coccidioidomycosis1 hi/oplasmosis1 & sporotri*osis4 7f7 ,au?orization ( appropriations ,!re is au?oriz$ to be appropriat$ to c>ry out ?is section #h1jjj1jjj = ea* ( fiscal ye>s #bjba ?r\gh #bjbe1 to rema9 available until exp5d$4 7g7 ,sunset ,! ,secret>y may n aw>d grants "u ?is section on or aft] ,octob] #a1 #bjbe4 #d4 ,,fda guidance = indu/ry on developm5t ( diagno/ics & antifungal drugs & vacc9es = ,valley ,fev] 7a7 ,draft guidance ,n lat] ?an #b ye>s aft] ! date ( ! enactm5t ( ?is ,act1 ! ,secret>y ( ,heal? & ,human ,s]vices1 act+ ?r\gh ! ,commission] ( ,food & ,drugs1 %all issue draft guidance = indu/ry = ! purposes ( assi/+ entities seek+ approval "u ! ,f$]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 bla/omycosis1 coccidioidomycosis1 hi/oplasmosis1 or sporotri*osis1 !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 to an application submitt$ "u section #cea7;a7 ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bfb7;a77 only if su* application is submitt$ 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 bla/omycosis1 coccidioidomycosis1 hi/oplasmosis1 or sporotri*osis4 #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$esignat+ subp>agraph 7,s7 z subp>agraph 7,t72 & 7#b7 by ins]t+ aft] subp>agraph 7,r7 ! foll[+3 7,s7 ,bla/omycosis1 coccidioidomycosis1 hi/oplasmosis1 & sporotri*osis4 4 #g4 ,e/abli%m5t ( antifungal resi/ance rese>* program model$ on ! ,,c>b-,x program 7a7 ,9 g5]al ,! ,secret>y ( ,heal? & ,human ,s]vices1 act+ ?r\gh ! ,director ( ! ,biom$ical ,advanc$ ,rese>* & ,developm5t ,au?ority1 %all c>ry out a program1 model$ on ! ,combat+ ,antibiotic ,resi/ant ,bact]ia ,accel]ator program ( ! ,dep>tm5t ( ,heal? & ,human ,s]vices 7commonly ref]r$ to z ,,c>b-,x71 = rese>* ) respect to antifungal resi/ance1 includ+ !rapies1 diagno/ics1 & vacc9es1 includ+ = coccidioidomycosis4 7b7 ,au?orization ( appropriations ,!re is au?oriz$ to be appropriat$ to c>ry out subsection 7a7 #aj1jjj1jjj = ea* ( fiscal ye>s #bjba ?r\gh #bjbe1 to rema9 available until exp5d$4 #h4 ,block*a9 pilot program = hospital data security = endemic fungal disease rese>* ,"p ,a ( title ,,iv ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bha et seq47 is am5d$ by add+ at ! end ! foll[+ new section3 #djd,o4 ,block*a9 pilot program = hospital data security = endemic fungal disease rese>* 7a7 ,9 g5]al ,! ,director ( ,,nih %all c>ry out a pilot program to conduct1 support1 & facilitate auditable rese>* on endemic fungal disease4 ,9 c>ry+ out su* program1 ! ,director ( ,,nih %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 endemic fungal disease means bla/omycosis1 coccidioidomycosis1 hi/oplasmosis1 & sporotri*osis4 7#c7 ,! t]m qualifi$ hospital means a hospital t is locat$ 9 a region 9 :i* endemic fungal disease is endemic4 7#d7 ,! 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#e7 ,! 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 is au?oriz$ to be appropriat$ to c>ry out ?is section #e1jjj1jjj = fiscal ye> #bjba1 to rema9 available until exp5d$4 4