,i #aah? ,,congress #b;d ,session ,h4 ,r4 #geci ,,9 ,,! ,,h\se ,,( ,,repres5tatives ,m>* #e1 #bjbd,mr4 ,fitzpatrick 7= himself & ,mr4 ,bi%op ( ,georgia7 introduc$ ! foll[+ bill2 :i* 0 ref]r$ to ! ,committee on ,en]gy & ,comm]ce ,a ,,bill ,to require ! ,secret>y ( ! ,treasury to gu>antee ,bio,bonds 9 ord] to provide fund+ = loans to eligible biom$ical companies & univ]sities to c>ry out cl9ical trials approv$ by ! ,food & ,drug ,adm9i/ration1 & = o!r purposes4 #a4 ,%ort title ,?is ,act may be cit$ z ! ,long-t]m ,opportunities = ,advanc+ ,new ,/udies = ,biom$ical ,rese>* ,act or ! ,,loans = ,biom$ical ,rese>* ,act4 #b4 ,biobonds program 7a7 ,9 g5]al ,n lat] ?an #ahj days aft] ! date ( enactm5t ( ?is ,act1 ! ,secret>y ( ! ,treasury1 9 consultation ) ! ,secret>y ( ,heal? & ,human ,s]vices1 %all e/abli% a program1 to be kn[n z ! ,bio,bonds ,program1 to increase innovative biom$ical rese>* into !rapies to address unmet m$ical ne$s1 "u :i* biom$ical rese>*]s seek+ to conduct cl9ical trials ) respect to a drug or device1 b :o _c secure appropriate fund+ to conduct su* trials1 receive f9ancial assi/ance ?r\gh-- 7#a7 ! pur*as+ ( loans by fiscal ag5ts "u section #c2 & 7#b7 ! sale & gu>antee ( ,bio,bonds collat]aliz$ by su* loans "u section #d4 7b7 ,biom$ical rese>*]s eligible = f9ancial assi/ance 7#a7 ,9 g5]al ,a p]son %all be eligible to receive a loan "u ! ,bio,bonds ,program if su* p]son is conduct+ or seek+ to conduct rese>* ) respect to a drug or device t is-- 7,a7 int5d$ = use to meet an unmet m$ical ne$ 7z det]m9$ by ! ,secret>y ( ,heal? & ,human ,s]vices72 & 7,b7 "u inve/igation 9 a controll$ cl9ical trial "u-- 7i7 an inve/igational drug application 9 effect "u section #eje7;i7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cee7;i77 or section #cea7;a77#c7 ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bfb7;a77#c77 7z applicable72 or 7ii7 an inve/igational device exemption 9 effect "u section #ebj7;g7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;j7g774 7#b7 ,rulemak+ ,! ,secret>y ( ! ,treasury1 9 consultation ) ! ,secret>y ( ,heal? & ,human ,s]vices1 %all issue rules to c>ry out ?is subsection4 #c4 ,pur*ase ( loans by fiscal ag5ts 7a7 ,9 g5]al ,fiscal ag5ts %all pur*ase loans-- 7#a7 made to an eligible recipi5t "u section #b7;b7 = ! purpose ( conduct+ ! applicable cl9ical trial describ$ 9 t section2 & 7#b7 ) respect to :i* ! fiscal ag5t det]m9es t ! borr[] has ! ability to repay ! loan1 bas$ on collat]al & f9ancial capabilities & n on ! prospects = success ( ! cl9ical trial4 7b7 ,priority = pur*ase ( loans ,! ,secret>y ( ! ,treasury %all issue rules to require fiscal ag5ts1 9 pur*as+ loans "u ?is section1 to pur*ase loans ) respect to a div]se range ( biom$ical projects & n to favor "o disease or disability1 & to give priority to loans ) pot5tial to address unmet public heal? ne$s across ! spectrum ( diseases & disabilities2 7c7 ,maximum loan am\nt ,a fiscal ag5t may n pur*ase loans 9 any "o ye> ) respect to a s+le recipi5t 9 an am\nt m ?an #be1jjj1jjj4 7d7 ,loan t]ms & conditions 7#a7 ,9 g5]al ,! ,secret>y ( ! ,treasury1 9 consultation ) ! ,secret>y ( ,heal? & ,human ,s]vices1 %all issue rules-- 7,a7 to e/abli% crit]ia = ! t]ms = loans t are eligible = pur*ase "u ?is section2 7,b7 to e/abli% crit]ia = ! int]e/ rate = loans t are eligible = pur*ase "u ?is section1 :i* %all be bas$ on applicable rates = obligations ( ! ,dep>tm5t ( ! ,treasury ( comp>able maturity plus a rate to be det]m9$ by ! ,secret>y ( ! ,treasury to reflect-- 7i7 prevail+ m>ket conditions2 7ii7 taxpay] protection2 & 7iii7 ! ne$ to ensure ample fund+ = cl9ical trials describ$ 9 section #b2 7,c7 9 accordance ) p>agraph 7#b71 to e/abli% an upfront fee ( n great] ?an #a p]c5t ( ea* loan pr9cipal am\nt at orig9ation to cov] adm9i/rative & f9anc+ co/s associat$ ) ! loans eligible = pur*ase "u ?is section2 & 7,d7 to p]mit ! use ( w>rants & simil> in/rum5ts ) respect to loans t are eligible = pur*ase "u ?is section1 :]e necess>y to protect taxpay] int]e/s4 7#b7 ,fees 7,a7 ,9 g5]al ,fees e/abli%$ "u p>agraph 7#a77;,c7 %all be f9anc$ by addition ( ! appropriate am\nt reflect+ ea* upfront fee to ! balance ( ea* loan ^u orig9ation & %all be collect$ 9 conc]t ) all loan paym5ts collect$ by ! fiscal ag5t4 7,b7 ,requirem5t ,if a loan is repaid ahead ( its /at$ maturity1 becomes del9qu5t1 or defaults1 !n ! full unpaid balance ( a fee e/abli%$ "u p>agraph 7#a77;,c7 t rema9s at su* "t %all be add$ to ! pr9cipal t mu/ be fully satisfi$4 #d4 ,bio,bonds 7a7 ,issuance ,ea* fiscal ag5t t pur*ases a loan "u section #c %all issue bonds1 to be kn[n z ,bio,bonds1 collat]aliz$ by su* loans1 & sell ! ,bio,bonds to inve/ors4 7b7 ,bio,bond gu>antee ,! ,secret>y ( ! ,treasury %all provide a gu>antee ( n great] ?an #ij p]c5t ( ! paym5t ( pr9cipal 7b n ! paym5t ( int]e/7 = a ,bio,bond4 7c7 ,auctions ,! ,secret>y ( ! ,treasury may-- 7#a7 au?orize fiscal ag5ts to use an auction to select ! pur*as]s ( ,bio,bonds2 & 7#b7 require su* auction to include a process t m9imizes ! risk to ! ,f$]al ,gov]nm5t ( ! ,f$]al gu>antee involv$ by all[+ bidd]s = a ,bio,bond to compete aga9/ ea* o!r by bidd+ on ! p]c5tage ( ! ,f$]al gu>antee "u subsection 7b7 ) respect to ! ,bio,bond1 ) ! bid = ! l[e/ p]c5tage w9n+ ! auction1 tak+ into acc\nt o!r t]ms & conditions set by ! issu] to ensure ! l[e/ total co/ to ! ,f$]al ,gov]nm5t4 7d7 ,portfolio div]sity ,) respect to an issuance ( ,bio,bonds & ! loans collat]aliz+ su* issuance1 n great] ?an #ae p]c5t ( ! pr9cipal am\nt ( su* issuance may relate to a gr\p ( relat$ diseases or disabilities 7z def9$ by ! ,secret>y ( ,heal? & ,human ,s]vices74 7e7 ,prioritization ( taxpay] int]e/s ,all proce$s receiv$ f ,biobond issuance %all be inve/$ 9 obligations ( ! ,f$]al ,gov]nm5t 9 ord] to ensure a rev5ue /ream 9 addition to loan repaym5t t protects taxpay]s4 ,all ,bio,bonds %all be /ructur$ to give fir/ priority to protect+ ! int]e/s ( ! ,unit$ ,/ates by ensur+ t-- 7#a7 all ca% proce$s receiv$ f ! repaym5t ( a ,bio,bond & income d]iv$ f loan-proce$ re9ve/m5t are fir/ us$ to r$uce ! am\nt ( pr9cipal gu>ante$ by ! ,secret>y ( ! ,treasury2 7#b7 ! ,secret>y ( ! ,treasury has a s5ior claim on all assets & collat]al "u a ,bio,bond to ! ext5t ! gu>antee provid$ by ! ,secret>y is n ext+ui%$2 & 7#c7 to ! ext5t t a ,biobond is fully repaid )\t resort to ! gu>antee1 all proce$s f re9ve/$ funds %all be ! prop]ty ( ! ,unit$ ,/ates4 7f7 ,rule ( con/ruction ,no?+ 9 ?is section may be con/ru$ to prohibit und]writ]s f v>y+ t]ms & conditions consi/5t ) ! rules issu$ by ! ,secret>y ( ! ,treasury ) respect to ,bio,bonds4 #e4 ,fiscal ag5ts 7a7 ,9 g5]al ,! ,secret>y ( ! ,treasury %all contract ) in/itutions to c>ry out ! duties ( fiscal ag5ts "u ?is ,act1 "u su* crit]ia z ! ,secret>y det]m9es appropriate4 7b7 ,s\nd und]writ+ practices ,! ,secret>y ( ! ,treasury %all issue rules to ensure t fiscal ag5ts use s\nd und]writ+ practices t protect ! int]e/s (-- 7#a7 ! ,unit$ ,/ates2 7#b7 ,bio,bond inve/ors2 & 7#c7 ! long-t]m promotion ( innovative biom$ical rese>* into !rapies to address unmet m$ical ne$s4 7c7 ,comp5sation ,a fiscal ag5t %all be comp5sat$ = p]=m+ duties "u ?is ,act f ! proce$s f ! sale ( ,biobonds issu$ by ! fiscal ag5t1 at su* rate & on su* t]ms z ! ,secret>y ( ! ,treasury may provide4 7d7 ,rulemak+ ,n lat] ?an #ahj days aft] ! date ( enactm5t ( ?is ,act1 ! ,secret>y ( ! ,treasury %all issue f9al rules to c>ry out ?is section4 #f4 ,reports 7a7 ,,gao /udy & reports on o!r rese>* projects 7#a7 ,ongo+ /udy ,! ,comptroll] ,g5]al ( ! ,unit$ ,/ates %all c>ry out an ongo+ /udy to consid] :e!r a program simil> to ! ,bio,bonds ,program %\ld be e/abli%$ = o!r biom$ical rese>* projects4 7#b7 ,report ,! ,comptroll] ,g5]al %all issue a report to ! ,congress1 n less frequ5tly ?an annually1 on all f9d+s & det]m9ations made 9 c>ry+ out ! /udy requir$ "u p>agraph 7#a74 7b7 ,reports on ! ,bio,bonds ,program ,n lat] ?an #b ye>s aft] ! date on :i* ,bio,bonds are fir/ issu$1 & annually !reaft] dur+ ! p]iod end+ on ! date t is #d ye>s aft] ! date on :i* ,bio,bonds are fir/ issu$1 ! ,comptroll] ,g5]al & ! ,secret>y ( ! ,treasury1 9 consultation ) ! ,secret>y ( ,heal? & ,human ,s]vices1 %all ea* issue a sep>ate report to ! ,congress on-- 7#a7 ! progress ( ! issuance ( ,bio,bonds2 7#b7 ! reasons = any problems a*iev+ desir$ volumes ( ,bio,bonds or ! ability ( ! ,bio,bonds ,program to proce$ at a fa/] pace2 7#c7 an analysis ( ! risk to ! ,gov]nm5t 9 provid+ ! ,f$]al gu>antee describ$ "u section #d7;b72 7#d7 any recomm5d$ improvem5ts to ! ,bio,bonds ,program2 & 7#e7 any o!r matt] t ! ,comptroll] ,g5]al or ! ,secret>y1 respectively1 det]m9es is appropriate4 #g4 ,au?orization ( appropriations 7a7 ,9 g5]al ,!re is au?oriz$ to be appropriat$ to ! ,secret>y ( ! ,treasury to pay = ! co/ ( gu>antee+ ,bio,bonds "u ?is ,act #aj1jjj1jjj1jjj = ea* ( fiscal ye>s #bjbe1 #bjbf1 & #bjbg4 7b7 ,program fund+ 7#a7 ,adm9i/rative exp5ses paid f bond sales ,except z provid$ "u p>agraph 7#b71 ! co/ ( c>ry+ out ?is ,act1 includ+ ! co/ to ! ,secret>y ( ! ,treasury 9 adm9i/]+ ! ,bio,bond ,program1 %all be recov]$ f ! proce$s f ! sale ( ,bio,bonds or f fees z set =? 9 p>agraph 7#c74 7#b7 ,specific appropriation or contribution ,no gu>antee %all be made "u ?is ,act unless-- 7,a7 an appropriation = ! full co/ ( ! gu>antee has be5 made2 7,b7 ! ,secret>y has receiv$ f ! ,bio,bond issu] a paym5t 9 full = ! co/ ( ! gu>antee2 or 7,c7 a comb9ation ( an appropriation & ! deposit ( a paym5t f ! ,bio,bond issu] has be5 made 9 a suffici5t am\nt to cov] ! full co/ ( ! gu>antee4 7#c7 ,gu>antee fees ,! ,secret>y ( ! ,treasury %all *>ge & collect fees = gu>antees "u ?is ,act 9 am\nts ! ,secret>y det]m9es are suffici5t to recov] applicable adm9i/rative exp5ses1 & su* fees-- 7,a7 %all be available to ! ,secret>y1 )\t fur!r appropriation1 to pay = ! adm9i/rative exp5ses relat$ to gu>antees "u ?is ,act2 & 7,b7 are au?oriz$ to rema9 available until exp5d$4 #h4 ,def9itions ,9 ?is ,act1 ! foll[+ def9itions apply3 7#a7 ,co/ ,! t]m co/ has ! mean+ giv5 to ! t]m co/ ( a loan gu>antee 9 section #ejb7e77;,c7 ( ! ,f$]al ,cr$it ,re=m ,act ( #aiij 7#b ,u4,s4,c4 #ffa;a7#e77;,c774 7#b7 ,eligible recipi5t ,! t]m eligible recipi5t means a p]son describ$ "u section #b7;b74 7#c7 ,fiscal ag5t ,! t]m fiscal ag5t means a p]son select$ z a fiscal ag5t "u section #e7;a74