,,ii #aaf? ,,congress #b;d ,session ,s4 #cafa ,,9 ,,! ,,s5ate ,,( ,,! ,,unit$ ,,/ates ,janu>y #h1 #bjbj,ms4 ,w>r5 7= h]self1 ,mr4 ,m>key1 ,ms4 ,baldw91 ,ms4 ,hirono1 ,mr4 ,van ,holl51 ,mr4 ,c>d91 ,mr4 ,book]1 ,mr4 ,casey1 ,mr4 ,s&]s1 ,mr4 ,ka9e1 ,ms4 ,h>ris1 ,mr4 ,:iteh\se1 & ,mr4 ,murphy7 introduc$ ! foll[+ bill2 :i* 0 read twice & ref]r$ to ! ,committee on ,heal?1 ,education1 ,labor1 & ,p5sions ,a ,,bill ,to e/abli% ! 8,biom$ical ,innovation ,fund01 & = o!r purposes4 #a4 ,%ort title ,?is ,act may be cit$ z ! ,national ,biom$ical ,rese>* ,act4 #b4 ,def9itions ,9 ?is ,act3 7#a7 ,discretion>y appropriations ,! t]m discretion>y appropriations has ! mean+ giv5 su* t]m 9 section #bej ( ! ,balanc$ ,budget & ,em]g5cy ,deficit ,control ,act ( #aihe 7#b ,u4,s4,c4 #ijj74 7#b7 ,fund ,! t]m ,fund means ! ,biom$ical ,innovation ,fund e/abli%$ "u section #c7;a74 7#c7 ,m9imum am\nt ,! t]m m9imum am\nt1 ) respect to ! applicable entity & = an applicable fiscal ye>-- 7,a7 means ! am\nt equal to ! greate/ am\nt ( discretion>y appropriations appropriat$ to su* entity = a fiscal ye> dur+ ! p]iod beg9n+ ) fiscal ye> #bjbj & end+ ) ! fiscal ye> be=e ! applicable fiscal ye>2 & 7,b7 does n include-- 7i7 any r$uction 9 an appropriation "u a seque/ration ord] issu$ "u ! ,balanc$ ,budget & ,em]g5cy ,deficit ,control ,act ( #aihe 7#b ,u4,s4,c4 #ijj et seq472 7ii7 am\nts collect$ by ! ,secret>y ( ,heal? & ,human ,s]vices "u sub*apt] ,c ( *apt] ,,vii ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;f et seq472 7iii7 am\nts di/ribut$ "u section #c7;c77#b72 or 7iv7 am\nts appropriat$ "u a supplem5tal or em]g5cy appropriation ,act4 #c4 ,biom$ical ,innovation ,fund 7a7 ,e/abli%m5t ,!re is e/abli%$ 9 ! ,treasury ( ! ,unit$ ,/ates a fund to be kn[n z ! ,biom$ical ,innovation ,fund1 to be adm9i/]$ by ! ,secret>y ( ! ,treasury1 consi/+ (-- 7#a7 ! am\nts transf]r$ to ! ,fund "u subsection 7b72 & 7#b7 any int]e/ e>n$ on ! inve/m5t ( su* am\nts "u subsection 7d74 7b7 ,commitm5t to biom$ical innovation ,n lat] ?an ,septemb] #a1 #bjbj1 & e ye> !reaft] ?r\gh #bjbi1 ! ,secret>y ( ! ,treasury %all transf] #aj1jjj1jjj1jjj f ! g5]al fund ( ! ,treasury into ! ,fund4 7c7 ,di/ribution ( am\nts 7#a7 ,calculation ( annual fund am\nt ,= fiscal ye> #bjbj & ea* fiscal ye> !reaft]1 n lat] ?an #ae days aft] ! latt] ( ! date ( enactm5t ( an appropriation ,act mak+ full fiscal ye> appropriations = su* fiscal ye> to ! entity describ$ 9 p>agraph 7#b77;,a7 & ! date ( enactm5t ( an appropriation ,act mak+ full fiscal ye> appropriations = su* fiscal ye> to ! entity describ$ 9 p>agraph 7#b77;,b71 ! ,secret>y ( ! ,treasury %all calculate ! total am\nt 9 ! ,fund t is available to be di/ribut$ = su* fiscal ye> 9 accordance ) p>agraph 7#b74 7#b7 ,di/ribution ( am\nts 9 ! ,fund ,subject to ! o!r provisions ( ?is section1 n lat] ?an #cj days aft] a calculation is made "u p>agraph 7#a7 = a fiscal ye>1 ! ,secret>y ( ! ,treasury %all di/ribute ! am\nt available to be di/ribut$ = su* fiscal ye> to ea* ( ! foll[+ entities3 7,a7 ,! ,national ,in/itutes ( ,heal?4 7,b7 ,! ,food & ,drug ,adm9i/ration4 7#c7 ,ratio ,! am\nt t ! ,secret>y ( ! ,treasury di/ributes to an entity describ$ 9 subp>agraph 7,a7 or 7,b7 ( p>agraph 7#b7 dur+ a fiscal ye> %all be> ! same relation to ! total am\nt calculat$ "u p>agraph 7#a7 = su* fiscal ye> z ! am\nt ( discretion>y appropriations appropriat$ to su* entity = su* fiscal ye> be>s to ! total am\nt ( discretion>y appropriations appropriat$ to ! entities describ$ 9 subp>agraphs 7,a7 & 7,b7 ( p>agraph 7#b7 = su* fiscal ye>4 7#d7 ,requirem5ts = di/ribution 7,a7 ,9 g5]al ,! ,secret>y ( ! ,treasury %all di/ribute am\nts 9 ! ,fund dur+ a fiscal ye> 9 accordance ) p>agraph 7#b7 only if-- 7i7 ! discretion>y appropriations = ! entity describ$ 9 p>agraph 7#b77;,a7 is great] ?an ! applicable m9imum am\nt = su* entity = su* fiscal ye>2 & 7ii7 ! discretion>y appropriations = ! entity describ$ 9 p>agraph 7#b77;,b7 is great] ?an ! applicable m9imum am\nt = su* entity = su* fiscal ye>4 7,b7 ,subsequ5t law impact+ di/ribution 7i7 ,bel[ m9imum am\nt ,if a law is enact$ or becomes effective aft] am\nts are appropriat$ to ea* entity describ$ 9 subp>agraph 7,a7 or 7,b7 ( p>agraph 7#b7 = a fiscal ye> & su* law decreases ! am\nt appropriat$ to ei!r su* entity = su* fiscal ye> f an am\nt t is great] ?an ! applicable m9imum am\nt to an am\nt t is less ?an or equal to su* m9imum am\nt1 any am\nts t 7 di/ribut$ by ! ,secret>y ( ! ,treasury "u p>agraph 7#b7 %all rema9 s di/ribut$ = su* fiscal ye>4 7ii7 ,above m9imum am\nt ,if a law is enact$ or becomes effective aft] am\nts are appropriat$ = a fiscal ye> to ea* entity describ$ 9 subp>agraph 7,a7 or 7,b7 ( p>agraph 7#b7 & su* law increases ! am\nt appropriat$ to ei!r su* entity = su* fiscal ye> f an am\nt t is less ?an or equal to ! m9imum am\nt to an am\nt t is great] ?an su* m9imum am\nt1 & all o!r conditions = di/ribution "u ?is p>agraph are met = ! fiscal ye>1 ! am\nts 9 ! ,fund %all be di/ribut$ by ! ,secret>y ( ! ,treasury "u p>agraph 7#b7 = su* fiscal ye>4 7,c7 ,failure to meet requirem5ts ,if ! requirem5ts "u subp>agraph 7,a7 are n met dur+ a fiscal ye>1 am\nts 9 ! ,fund %all-- 7i7 n be di/ribut$ "u p>agraph 7#b72 & 7ii7 rema9 9 ! ,fund1 e>n+ int]e/ 9 accordance ) subsection 7d71 until su* requirem5ts1 or ! conditions "u subsection 7f71 are met dur+ a fiscal ye>4 7#e7 ,allocations 7,a7 ,9 g5]al ,if am\nts are di/ribut$ "u p>agraph 7#b7 dur+ a fiscal ye>1 ( ! am\nts s di/ribut$-- 7i7 #bj p]c5t %all become available = obligation dur+ ! fiscal ye> dur+ :i* ! di/ribution is made2 7ii7 #bj p]c5t %all become available = obligation dur+ ! fir/ fiscal ye> aft] ! fiscal ye> dur+ :i* ! di/ribution is made2 7iii7 #bj p]c5t %all become available = obligation dur+ ! second fiscal ye> aft] ! fiscal ye> dur+ :i* ! di/ribution is made2 7iv7 #bj p]c5t %all become available = obligation dur+ ! ?ird fiscal ye> aft] ! fiscal ye> dur+ :i* ! di/ribution is made2 & 7v7 #bj p]c5t %all become available = obligation dur+ ! f\r? fiscal ye> aft] ! fiscal ye> dur+ :i* ! di/ribution is made4 7,b7 ,availability ( am\nts ,any am\nts di/ribut$ "u p>agraph 7#b7 %all rema9 available until exp5d$4 7#f7 ,au?oriz$ uses ,am\nts di/ribut$ "u p>agraph 7#b7 f ! ,fund %all be us$ to support-- 7,a7 basic rese>* on ! und]ly+ basis = disease to bett] address disease prev5tion1 diagnosis1 & treatm5t2 7,b7 rese>* t fo/]s disruptive innovation1 su* z-- 7i7 rese>* on diseases or conditions = :i* treatm5ts exi/ b are inadequate1 includ+ *ronic & acute pa92 7ii7 rese>* on diseases or conditions = :i* !re are unmet m$ical ne$s2 7iii7 rese>* on diseases or conditions = :i* treatm5ts exi/ b ! side effect pr(iles ( su* treatm5ts limit !rapeutic pot5tial2 7iv7 rese>* on new approa*es to treatm5t ( diseases us+ drugs1 devices1 or !rapies t1 at ! "t ( di/ribution "u p>agraph 7#b71 are n us$ or are und]us$2 or 7v7 rese>* conduct$ by exp]i5c$ inve/igators ) a hi/ory ( productive & innovative rese>*1 su* t fund+ provides long-t]m /ability = su* rese>* & all[s su* inve/igators to take great] risks1 be m adv5tur\s 9 _! l9es ( inquiry1 or take ! "t to develop gr\ndbreak+ te*niques2 7,c7 rese>* relat$ to diseases t disproportionally acc\nt = ,f$]al heal? c>e sp5d+1 includ+ sp5d+ "u ! ,m$ic>e program "u title ,,xviii ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acie et seq471 ! ,m$icaid program "u title ,,xix ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acif et seq471 ! ,/ate ,*ildr5's ,heal? ,insurance ,program "u title ,,xxi ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acig;aa et seq471 ! ,,tric>e program "u *apt] #ee ( title #aj1 ,unit$ ,/ates ,code1 & hospital c>e & m$ical s]vices furni%$ by ! ,dep>tm5t ( ,vet]ans ,affairs "u *apt]s #ag & #ah ( title #ch1 ,unit$ ,/ates ,code1 su* z rese>* relat+ to-- 7i7 diseases t disproportionally impact old] individuals2 7ii7 deg5]ative diseases2 or 7iii7 *ronic conditions2 7,d7 e>ly c>e] sci5ti/s1 su* z ?r\gh-- 7i7 aw>d+ rese>* project grants t support discrete1 specifi$1 & circumscrib$ projects to be p]=m$ by ! inve/igator 9 an area repres5t+ ! specific int]e/s & compet5cies ( su* inve/igator1 to inve/igators-- 7,i7 :o are )9 #aj ye>s ( complet+ a t]m9al rese>* degree2 or 7,,ii7 :o are )9 #aj ye>s ( complet+ a m$ical resid5cy2 7ii7 aw>d+ grants t support c>e] developm5t exp]i5ces t lead to e>li] rese>* indep5d5ce2 & 7iii7 aw>d+ grants t support innovative tra9+ programs t1 9 addition to sci5tific tra9+1 provide additional tra9+ to enhance employm5t opportunities1 includ+ tra9+ 9 managem5t & bus9ess1 to-- 7,i7 graduate /ud5ts2 7,,ii7 po/-doctoral fell[s2 7,,iii7 individuals )9 #aj ye>s ( complet+ a t]m9al rese>* degree2 or 7,,iv7 individuals )9 #aj ye>s ( complet+ a m$ical resid5cy2 7,e7 rese>* ef=ts t increase ! pot5tial = break?r\gh discov]ies across a div]se set ( inve/igators1 rese>* gr\ps1 & in/itutions1 :i* may include support+-- 7i7 inve/igators t are memb]s ( traditionally und]repres5t$ racial & e?nic gr\ps2 7ii7 rese>* gr\ps t are div]se 9 size2 or 7iii7 in/itutions t increase ! geographic div]sity ( fund+ provid$ by ! ,national ,in/itutes ( ,heal?2 7,f7 ! developm5t1 review1 & po/-m>ket surveillance ( m$ical products1 z det]m9$ by ! ,secret>y ( ,heal? & ,human ,s]vices2 & 7,g7 rese>* to c>ry out ! goals ( ! /rategy & implem5tation plan = advanc+ sci5ce to promote public heal? & advance innovation 9 regulatory decision mak+ develop$ "u section #aabd ( ! ,food & ,drug ,adm9i/ration ,safety & ,innovation ,act 7#ba ,u4,s4,c4 #cic note71 & o!r su* rese>* activities to improve ! pr$ictability1 consi/5cy1 & effici5cy ( sci5ce-bas$ decision mak+ conc]n+ m$ical products1 includ+ facilitat+ ! timely introduction ( new te*nologies & me?odologies 9 a safe & effective mann] z det]m9$ by ! ,secret>y ( ,heal? & ,human ,s]vices4 7#g7 ,int]ag5cy transf]s ,am\nts di/ribut$ f ! ,fund "u p>agraph 7#b7 %all be available ?r\gh int]ag5cy transf] to support rese>* conduct$ jo9tly by ! ,national ,in/itutes ( ,heal? or ! ,food & ,dug ,adm9i/ration & o!r ,f$]al ag5cies4 7d7 ,inve/m5t ( fund balances 7#a7 ,9 g5]al ,am\nts 9 ! ,fund %all be inve/$ 9 int]e/-be>+ obligations ( ! ,unit$ ,/ates 9 ! =m ( special-issue securities1 pay+ int]e/ to ! ,fund at rates applicable to su* securities1 & su* am\nts %all be r$eemable by ! ,secret>y ( ! ,treasury1 = purposes ( di/ribution "u subsection 7c77#b74 7#b7 ,di/ribut$ am\nts ,any am\nts t h be5 di/ribut$ dur+ a fiscal ye> "u subsection 7c77#b7 %all n be consid]$ am\nts 9 ! ,fund = ! purpose ( ?is subsection4 7e7 ,prohibition ,am\nts 9 ! ,fund may n be made available = any use o!r ?an a use describ$ 9 subsection 7c77#f74 7f7 ,transf] ,to r$uce ! deficit 7#a7 ,9 g5]al ,subject to p>agraph 7#b71 if am\nts 9 ! ,fund are n di/ribut$ by ! ,secret>y ( ! ,treasury "u subsection 7c77#b7 = any #c consecutive fiscal ye>s1 ! ,secret>y ( ! ,treasury %all transf] all am\nts 9 ! ,fund to ! g5]al fund ( ! ,treasury = purposes ( r$uc+ ! ,f$]al deficit4 7#b7 ,ye> ( di/ribution ,= purposes ( p>agraph 7#a71 #c fiscal ye>s %all n be deem$ to be consecutive if dur+ any ( su* ye>s ! ,secret>y ( ! ,treasury has transf]r$ all am\nts 9 ! ,fund into ! g5]al fund ( ! ,treasury 9 accordance ) su* p>agraph4 7g7 ,reports 7#a7 ,secret>y reports 7,a7 ,9 g5]al ,n lat] ?an ,novemb] #cj1 #bjba1 & e ye> !reaft] ?r\gh #bjcj ! ,secret>y ( ! ,treasury %all submit to ! ,committee on ,appropriations ( ! ,s5ate1 ! ,committee on ,appropriations ( ! ,h\se ( ,repres5tatives1 & ! au?oriz+ committees a report on ! op]ation ( ! ,fund dur+ ! fiscal ye>4 7,b7 ,cont5ts ,ea* report %all include1 = ! fiscal ye> cov]$ by ! report1 ea* ( ! foll[+3 7i7 ,a /atem5t ( ! am\nts1 & ! s\rce ( su* am\nts1 transf]r$ to1 cr$it$ to1 & deposit$ into ! ,fund4 7ii7 ,a description ( any am\nts di/ribut$ "u subsection 7c77#b7 dur+ ! fiscal ye>4 7iii7 ,a /atem5t ( ! balance rema9+ 9 ! ,fund at ! end ( ! fiscal ye>4 7iv7 ,a /atem5t ( ! am\nts inve/$ 9 int]e/-be>+ obligations ( ! ,unit$ ,/ates1 & ! int]e/ e>n$ on su* inve/m5ts4 7#b7 ,ag5cy reports 7,a7 ,annual report+ ,= ea* fiscal ye> 9 :i* am\nts are available = obligation "u subsection 7c77#e71 ! ,director ( ! ,national ,in/itutes ( ,heal? & ! ,commission] ( ,food & ,drugs %all report on ! use ( su* am\nts 9 ! annual budget submission = su* fiscal ye> ( ! ,national ,in/itutes ( ,heal? & ! ,food & ,drug ,adm9i/ration1 respectively4 7,b7 ,,nih reports ,section #djc7;a7 ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bhc7;a77 is am5d$ by add+ at ! end ! foll[+3 7#g7 ,a summ>y ( ! use ( funds di/ribut$ "u section #c7;c77#b77;,a7 ( ! ,national ,biom$ical ,rese>* ,act to ! ,national ,in/itutes ( ,heal? f ! ,biom$ical ,innovation ,fund1 e/abli%$ "u section #c7;a7 ( su* ,act1 includ+ ! am\nts allocat$ to ea* national rese>* in/itute & national c5t]1 ! projects fund$ by su* am\nts1 ! accompli%m5ts t h result$ f su* am\nts1 & ! goals = future use ( su* am\nts4 4 7,c7 ,,fda reports ,= ea* #c-ye> p]iod beg9n+ on ! date ( enactm5t ( ?is ,act1 if am\nts are di/ribut$ "u subsection 7c77#b77;,b7 to ! ,food & ,drug ,adm9i/ration = any fiscal ye> dur+ su* #c-ye> p]iod1 ! ,commission] ( ,food & ,drugs %all submit1 to ! ,committee on ,heal?1 ,education1 ,labor1 & ,p5sions ( ! ,s5ate & ! ,committee on ,en]gy & ,comm]ce ( ! ,h\se ( ,repres5tatives1 a report t describes ! allocation ( su* am\nts )9 ! ,food & ,drug ,adm9i/ration1 ! projects fund$ by su* am\nts1 ! accompli%m5ts t h result$ f su* am\nts1 & ! goals = future use ( su* am\nts4 #d4 ,budget>y provisions 7a7 ,discretion>y sp5d+ limits ,! ,(fice ( ,managem5t & ,budget %all n include am\nts di/ribut$ "u section #c7;c77#b7 dur+ a fiscal ye> 9 det]m9+ :e!r !re has be5 a brea* ( ! discretion>y sp5d+ limits "u ! ,balanc$ ,budget & ,em]g5cy ,deficit ,control ,act ( #aihe 7#b ,u4,s4,c4 #ijj et seq47 dur+ ! fiscal ye>4 7b7 ,budget en=cem5t ,if a bill or jo9t resolution1 or am5dm5t !reto or conf]5ce report !reon1 if enact$1 w\ld cause am\nts to be di/ribut$ "u section #c7;c77#b71 ! ,*airp]son ( ! ,committee on ! ,budget ( ! ,h\se ( ,repres5tatives & ,*airp]son ( ! ,committee on ! ,budget ( ! ,s5ate %all n include ! budget>y effects ( su* di/ribution = purposes ( en=cem5t ( budget>y allocations1 aggregates1 levels1 & limits 9 ! ,h\se ( ,repres5tatives & ! ,s5ate4 #e4 ,(fsets ,x is ! s5se ( ! ,s5ate t ! am\nts transf]r$ "u section #c7;b7 %\ld be (fset completely4