,i #aag? ,,congress #a/ ,session ,h4 ,r4 #cdcg ,,9 ,,! ,,h\se ,,( ,,repres5tatives ,may #bj1 #bjba,mr4 ,ru% 7= himself1 ,mr4 ,fitzpatrick1 ,mr4 ,bi%op ( ,georgia1 ,mr4 ,c>son1 ,mr4 ,coh51 ,mr4 ,coop]1 ,mr4 ,danny ,k4 ,davis ( ,ill9ois1 ,mr4 ,grijalva1 ,mr4 ,lev9 ( ,cali=nia1 ,mr4 ,s*neid]1 ,ms4 ,sewell1 & ,mr4 ,?ompson ( ,mississippi7 introduc$ ! foll[+ bill2 :i* 0 ref]r$ to ! ,committee on ,en]gy & ,comm]ce ,a ,,bill ,to require ! ,secret>y ( ,heal? & ,human ,s]vices 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 ( ,heal? & ,human ,s]vices1 9 consultation ) ! ,secret>y ( ! ,treasury1 %all e/abli% a program1 to be kn[n z ! ,biobonds ,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* trials 7z det]m9$ by ! ,secret>y ( ! ,treasury71 receive f9ancial assi/ance ?r\gh-- 7#a7 ! pur*as+ ( loans by fiscal ag5ts "u section #c2 & 7#b7 ! sale & gu>antee ( ,biobonds compris$ ( ^! loans "u section #d4 7b7 ,biom$ical rese>*]s eligible = f9ancial assi/ance 7#a7 ,9 g5]al ,a p]son %all be eligible to receive a loan "u ! ,biobonds ,program if su* p]son is conduct+ or seek+ to conduct rese>* ) respect to a drug or device t is-- 7,a7 int5d$ = 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 ( ,heal? & ,human ,s]vices1 9 consultation ) ! ,secret>y ( ! ,treasury1 %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 = ! purpose ( conduct+ ! applicable cl9ical trial2 & 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 = loans ,! ,secret>y ( ,heal? & ,human ,s]vices %all issue rules to require fiscal ag5ts1 9 pur*as+ loans "u ?is section1 to-- 7#a7 pur*ase loans ) respect to a div]se range ( biom$ical projects & n to favor "o disease or disability1 b ) priority giv5 to loans ) pot5tial to address unmet public heal? ne$s across ! spectrum ( diseases & disabilities2 7#b7 consid] z an important crit]ion = pur*as+ loans ) respect to cl9ical trials t !y are be+ conduct$ by wom5 rese>*]s or rese>*]s :o are memb]s ( a racial & e?nic m9ority gr\p or disabl$2 & 7#c7 prioritize pur*as+ loans ) respect to cl9ical trials t include1 :]e appropriate1 repres5tative levels ( wom51 memb]s ( a racial & e?nic m9ority gr\ps1 disabl$ individuals1 & o!r div]se p>ticipants1 z specifi$ 9 guidance issu$ "u section #eje7;b7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act4 7c7 ,maximum loan am\nt ,a fiscal ag5t may n pur*ase loans 9 any "o ye> ) respect to a s+le recipi5t 9 an am\nt m ?an #be1jjj1jjj4 7d7 ,loan t]ms & conditions ,! ,secret>y ( ,heal? & ,human ,s]vices1 9 consultation ) ! ,secret>y ( ! ,treasury1 %all issue rules to-- 7#a7 e/abli% crit]ia = ! t]ms = loans t are eligible = pur*ase "u ?is section2 7#b7 e/abli% crit]ia = ! int]e/ rate = loans t are eligible = pur*ase "u ?is section1 :i* %all be bas$ on applicable rates = obligations ( ! ,dep>tm5t ( ! ,treasury ( comp>able maturity plus a rate to be det]m9$ by ! ,secret>y ( ! ,treasury to reflect-- 7,a7 prevail+ m>ket conditions2 7,b7 taxpay] protection2 & 7,c7 ! ne$ to ensure ample fund+ = cl9ical trials describ$ "u section #b2 & 7#c7 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 #d4 ,bio,bonds 7a7 ,issuance ,! fiscal ag5ts %all issue bonds1 to be kn[n z ,bio,bonds1 collat]aliz$ by loans pur*as$ "u ?is ,act1 & sell ! ,bio,bonds to inve/ors4 7b7 ,bio,bond gu>antee ,! ,secret>y ( ,heal? & ,human ,s]vices %all provide a gu>antee on ! paym5t ( pr9cipal 7b n ! paym5t ( int]e/7 = ea* ,bio,bond1 on a bond-by-bond basis1 9 an am\nt to be det]m9$ by ! ,secret>y1 b 9 no case may ! am\nt ( su* gu>antee be m ?an #ij p]c5t ( ! pr9cipal ( ! ,bio,bond4 7c7 ,size ( issuances ,! ,secret>y ( ,heal? & ,human ,s]vices1 9 consultation ) ! ,secret>y ( ! ,treasury1 %all e/abli% ! size ( ea* ,bio,bond issuance1 to ensure m>ket acceptance1 portfolio div]sification1 & ! protection ( taxpay] int]e/s4 7d7 ,auctions ,! ,secret>y ( ,heal? & ,human ,s]vices 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 ! ,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$]al gu>antee "u subsection 7b7 ) respect to ! ,bio,bond1 ) ! bid = ! l[e/ p]c5tage w9n+ ! auction1 tak+ into acc\nt o!r t]ms & conditions set by ! issu] to ensure ! l[e/ total co/ to ! ,gov]nm5t4 7e7 ,portfolio div]sity ,) respect to an issuance ( ,bio,bonds & ! loans collat]aliz+ su* issuance1 no m ?an #ae p]c5t ( ! pr9cipal am\nt ( su* issuance may relate to a gr\p ( relat$ diseases or disabilities 7z def9$ by ! ,secret>y ( ,heal? & ,human ,s]vices74 7f7 ,prioritization ( taxpay] int]e/s ,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 are fir/ us$ to r$uce ! am\nt ( pr9cipal gu>ante$ by ! ,secret>y ( ,heal? & ,human ,s]vices2 & 7#b7 ! ,secret>y ( ,heal? & ,human ,s]vices 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%$4 #e4 ,fiscal ag5ts 7a7 ,9 g5]al ,! ,secret>y ( ! ,treasury %all contract ) in/itutions to c>ry out ! duties ( fiscal ag5ts "u ?is ,act1 "u su* crit]ia z ! ,secret>y ( ,heal? & ,human ,s]vices1 9 consultation ) ! ,secret>y ( ! ,treasury1 det]m9es appropriate4 7b7 ,s\nd und]writ+ practices ,! ,secret>y ( ! ,treasury %all issue rules to ensure t fiscal ag5ts use s\nd und]writ+ practices t protect ! int]e/s (-- 7#a7 ! ,unit$ ,/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$1 ! ,comptroll] ,g5]al & ! ,secret>y ( ,heal? & ,human ,s]vices %all ea* issue a sep>ate report to ! ,congress on-- 7#a7 ! progress ( ! issuance ( ,bio,bonds2 7#b7 ! reasons = any problems a*iev+ desir$ volumes ( ,bio,bonds or ! ability ( ! ,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 ! ,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 ( ,heal? & ,human ,s]vices to pay = ! co/ ( gu>antee+ ,bio,bonds "u ?is ,act #aj1jjj1jjj1jjj = ea* ( fiscal ye>s #bjbb1 #bjbc1 & #bjbd4 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 ( ,heal? & ,human ,s]vices 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 ! bond issu] into ! ,treasury has be5 made 9 a suffici5t am\nt to cov] ! full co/ ( ! gu>antee4 7#c7 ,co/ ( gu>antees 7,a7 ,9 g5]al ,! ,secret>y ( ,heal? & ,human ,s]vices %all *>ge & collect fees = gu>antees "u ?is ,act 9 am\nts ! ,secret>y det]m9es are suffici5t to recov] applicable adm9i/rative exp5ses4 7,b7 ,availability ,fees collect$ "u ?is subsection-- 7i7 %all be deposit$ by ! ,secret>y into ! ,treasury2 & 7ii7 are au?oriz$ to rema9 available until exp5d$4 #h4 ,def9itions ,9 ?is ,act3 7#a7 ,co/ ,! t]m co/ has ! mean+ giv5 to ! t]m co/ ( a loan gu>antee 9 section #ejb7e77;,c7 ( ! ,f$]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