,9 ! ,s5ate ( ! ,unit$ ,/ates1 ,septemb] #bi1 #bjbb4 ,am5dm5t3 ,t ! bill f ! ,h\se ( ,repres5tatives 7,h4,r4 #fhcc7 entitl$ ,an ,act to am5d title ,,xxvii ( ! ,public ,heal? ,s]vice ,act1 ! ,int]nal ,rev5ue ,code ( #aihf1 & ! ,employee ,retirem5t ,income ,security ,act ( #aigd to e/abli% requirem5ts ) respect to co/-%>+ = c]ta9 insul9 products1 & = o!r purposes41 d pass ) ! foll[+ ,/rike all aft] ! enact+ clause & ins]t ! foll[+3 #a4 ,%ort title ,?is ,act may be cit$ z ! ,cont9u+ ,appropriations & ,ukra9e ,supplem5tal ,appropriations ,act1 #bjbc4 #b4 ,table ( ,cont5ts ,sec4 #a4 ,%ort ,title4,sec4 #b4 ,table ( ,cont5ts4,sec4 #c4 ,ref]5ces4,sec4 #d4 ,paym5t to ,wid[s & ,heirs ( ,deceas$ ,memb]s ( ,congress4 ,division ,a--,cont9u+ ,appropriations ,act1 #bjbc;,division ,b--,ukra9e ,supplem5tal ,appropriations ,act1 #bjbc;,division ,c--,o!r ,matters,title ,i--,ext5sions1 ,te*nical ,corrections1 & ,o!r ,matters,title ,,ii--,budget>y ,effects,division ,d--,heal? & ,human ,s]vices ,extensions,title ,i--,m$ic>e & ,medicaid,title ,,ii--,human ,services,title ,,iii--,public ,health,title ,,iv--,indian ,health,division ,e--,vet]ans ,affairs ,ext5sions ,title ,i--,ext5sions ( au?orities relat+ to heal? care,title ,,ii--,ext5sions ( au?orities relat+ to benefits,title ,,iii--,ext5sions ( au?orities relat+ to homeless veterans,title ,,iv--,ext5sions ( o!r authorities,division ,f--,,fda ,us] ,fee ,reau?orization ,act ( #bjbb;,division ,g--,h]mit's ,peak_/,calf ,canyon ,fire ,assi/ance ,act #c4 ,ref]5ces ,except z expressly provid$ o!rwise1 any ref]5ce to ?is ,act conta9$ 9 any division ( ?is ,act %all be treat$ z ref]r+ only to ! provisions ( t division4 #d4 ,paym5t to ,wid[s & ,heirs ( ,deceas$ ,memb]s ( ,congress ,!re is h]eby appropriat$ = fiscal ye> #bjbc1 out ( any money 9 ! ,treasury n o!rwise appropriat$1 = paym5t to ,dean ,swih>t1 b5efici>y ( ,jacquel9e ,walorski-,swih>t1 late a ,repres5tative f ! ,/ate ( ,indiana1 #agd1jjj4 ,a ,cont9u+ ,appropriations ,act1 #bjbc ,! foll[+ sums are h]eby appropriat$1 out ( any money 9 ! ,treasury n o!rwise appropriat$1 & out ( applicable corporate or o!r rev5ues1 receipts1 & funds1 = ! sev]al dep>tm5ts1 ag5cies1 corporations1 & o!r organizational units ( ,gov]nm5t = fiscal ye> #bjbc1 & = o!r purposes1 namely3 #aja4 ,su* am\nts z may be necess>y1 at a rate = op]ations z provid$ 9 ! applicable appropriations ,acts = fiscal ye> #bjbb & "u ! au?ority & conditions provid$ 9 su* ,acts1 = cont9u+ projects or activities 7includ+ ! co/s ( direct loans & loan gu>antees7 t are n o!rwise specifically provid$ = 9 ?is ,act1 t 7 conduct$ 9 fiscal ye> #bjbb1 & = :i* appropriations1 funds1 or o!r au?ority 7 made available 9 ! foll[+ appropriations ,acts3 7#a7 ,! ,agriculture1 ,rural ,developm5t1 ,food & ,drug ,adm9i/ration1 & ,relat$ ,ag5cies ,appropriations ,act1 #bjbb 7division ,a ( ,public ,law #aag-ajc71 except section #ghc1 & except t section #ghe %all be appli$ by sub/itut+ #abe1jjj1jjj = #bej1jjj1jjj4 7#b7 ,! ,comm]ce1 ,ju/ice1 ,sci5ce1 & ,relat$ ,ag5cies ,appropriations ,act1 #bjbb 7division ,b ( ,public ,law #aag-ajc71 except section #eba7;c77#a74 7#c7 ,! ,dep>tm5t ( ,def5se ,appropriations ,act1 #bjbb 7division ,c ( ,public ,law #aag-ajc74 7#d7 ,! ,en]gy & ,wat] ,developm5t & ,relat$ ,ag5cies ,appropriations ,act1 #bjbb 7division ,d ( ,public ,law #aag-ajc74 7#e7 ,! ,f9ancial ,s]vices & ,g5]al ,gov]nm5t ,appropriations ,act1 #bjbb 7division ,e ( ,public ,law #aag-ajc71 except ! matt] "u ! head+ ,po/al ,regulatory ,commission 9 title ,v4 7#f7 ,! ,dep>tm5t ( ,homel& ,security ,appropriations ,act1 #bjbb 7division ,f ( ,public ,law #aag-ajc71 except sections #edd & #ede1 & includ+ title ,,ii ( division ,o ( ,public ,law #aag-ajc4 7#g7 ,! ,dep>tm5t ( ! ,int]ior1 ,environm5t1 & ,relat$ ,ag5cies ,appropriations ,act1 #bjbb 7division ,g ( ,public ,law #aag-ajc74 7#h7 ,! ,dep>tm5ts ( ,labor1 ,heal? & ,human ,s]vices1 & ,education1 & ,relat$ ,ag5cies ,appropriations ,act1 #bjbb 7division ,h ( ,public ,law #aag-ajc71 & section #afb ( division ,a ( ,public ,law #aag-dc4 7#i7 ,! ,legislative ,bran* ,appropriations ,act1 #bjbb 7division ,i ( ,public ,law #aag-ajc71 & section #f 9 ! matt] prec$+ division ,a ( ,public ,law #aag-ajc4 7#aj7 ,! ,milit>y ,con/ruction1 ,vet]ans ,affairs1 & ,relat$ ,ag5cies ,appropriations ,act1 #bjbb 7division ,j ( ,public ,law #aag-ajc74 7#aa7 ,! ,dep>tm5t ( ,/ate1 ,=eign ,op]ations1 & ,relat$ ,programs ,appropriations ,act1 #bjbb 7division ,k ( ,public ,law #aag-ajc71 except ! fir/ proviso ( section #gjfi7;e74 7#ab7 ,! ,transportation1 ,h\s+ & ,urban ,developm5t1 & ,relat$ ,ag5cies ,appropriations ,act1 #bjbb 7division ,l ( ,public ,law #aag-ajc74 #ajb4 7a7 ,no appropriation or funds made available or au?ority grant$ pursuant to section #aja = ! ,dep>tm5t ( ,def5se %all be us$ =3 7#a7 ! new production ( items n fund$ = production 9 fiscal ye> #bjbb or prior ye>s2 7#b7 ! increase 9 production rates above ^? su/a9$ ) fiscal ye> #bjbb funds2 or 7#c7 ! initiation1 resumption1 or cont9uation ( any project1 activity1 op]ation1 or organization 7def9$ z any project1 subproject1 activity1 budget activity1 program elem5t1 & subprogram )9 a program elem5t1 & = any inve/m5t items def9$ z a ,p-#a l9e item 9 a budget activity )9 an appropriation acc\nt & an ,r-#a l9e item t includes a program elem5t & subprogram elem5t )9 an appropriation acc\nt7 = :i* appropriations1 funds1 or o!r au?ority 7 n available dur+ fiscal ye> #bjbb4 7b7 ,no appropriation or funds made available or au?ority grant$ pursuant to section #aja = ! ,dep>tm5t ( ,def5se %all be us$ to initiate multi-ye> procurem5ts utiliz+ advance procurem5t fund+ = economic ord] quantity procurem5t unless specifically appropriat$ lat]4 #ajc4 ,appropriations made by section #aja %all be available to ! ext5t & 9 ! mann] t w\ld be provid$ by ! p]t95t appropriations ,act4 #ajd4 ,except z o!rwise provid$ 9 section #ajb1 no appropriation or funds made available or au?ority grant$ pursuant to section #aja %all be us$ to initiate or resume any project or activity = :i* appropriations1 funds1 or o!r au?ority 7 n available dur+ fiscal ye> #bjbb4 #aje4 ,appropriations made & au?ority grant$ pursuant to ?is ,act %all cov] all obligations or exp5ditures incurr$ = any project or activity dur+ ! p]iod = :i* funds or au?ority = su* project or activity are available "u ?is ,act4 #ajf4 ,unless o!rwise provid$ = 9 ?is ,act or 9 ! applicable appropriations ,act = fiscal ye> #bjbc1 appropriations & funds made available & au?ority grant$ pursuant to ?is ,act %all be available until :i*ev] ( ! foll[+ fir/ occurs3 7#a7 ,! enactm5t into law ( an appropriation = any project or activity provid$ = 9 ?is ,act4 7#b7 ,! enactm5t into law ( ! applicable appropriations ,act = fiscal ye> #bjbc )\t any provision = su* project or activity4 7#c7 ,decemb] #af1 #bjbb4 #ajg4 ,exp5ditures made pursuant to ?is ,act %all be *>g$ to ! applicable appropriation1 fund1 or au?orization :5ev] a bill 9 :i* su* applicable appropriation1 fund1 or au?orization is conta9$ is enact$ into law4 #ajh4 ,appropriations made & funds made available by or au?ority grant$ pursuant to ?is ,act may be us$ )\t reg>d to ! "t limitations = submission & approval ( apportionm5ts set =? 9 section #aeac ( title #ca1 ,unit$ ,/ates ,code1 b no?+ 9 ?is ,act may be con/ru$ to waive any o!r provision ( law gov]n+ ! apportionm5t ( funds4 #aji4 ,not)/&+ any o!r provision ( ?is ,act1 except section #ajf1 = ^? programs t w\ld o!rwise h high initial rates ( op]ation or complete di/ribution ( appropriations at ! beg9n+ ( fiscal ye> #bjbc because ( di/ributions ( fund+ to ,/ates1 =eign c\ntries1 grantees1 or o!rs1 su* high initial rates ( op]ation or complete di/ribution %all n be made1 & no grants %all be aw>d$ = su* programs fund$ by ?is ,act t w\ld imp+e on f9al fund+ pr]ogatives4 #aaj4 ,?is ,act %all be implem5t$ s t only ! mo/ limit$ fund+ action ( t p]mitt$ 9 ! ,act %all be tak5 9 ord] to provide = cont9uation ( projects & activities4 #aaa4 7a7 ,= entitlem5ts & o!r m&atory paym5ts ^: budget au?ority 0 provid$ 9 appropriations ,acts = fiscal ye> #bjbb1 & = activities "u ! ,food & ,nutrition ,act ( #bjjh1 activities %all be cont9u$ at ! rate to ma9ta9 program levels "u curr5t law1 "u ! au?ority & conditions provid$ 9 ! applicable appropriations ,act = fiscal ye> #bjbb1 to be cont9u$ ?r\gh ! date specifi$ 9 section #ajf7c74 7b7 ,not)/&+ section #ajf1 obligations = m&atory paym5ts due on or ab\t ! fir/ day ( any mon? t beg9s aft] ,octob] #bjbb b n lat] ?an #cj days aft] ! date specifi$ 9 section #ajf7c7 may cont9ue to be made1 & funds %all be available = su* paym5ts4 #aab4 ,am\nts made available "u section #aja = civilian p]sonnel comp5sation & b5efits 9 ea* dep>tm5t & ag5cy may be apportion$ up to ! rate = op]ations necess>y to avoid furl\ghs )9 su* dep>tm5t or ag5cy1 consi/5t ) ! applicable appropriations ,act = fiscal ye> #bjbb1 except t su* au?ority provid$ "u ?is section %all n be us$ until aft] ! dep>tm5t or ag5cy has tak5 all necess>y actions to r$uce or def] non-p]sonnel-relat$ adm9i/rative exp5ses4 #aac4 ,funds appropriat$ by ?is ,act may be obligat$ & exp5d$ not)/&+ section #aj ( ,public ,law #ia-fgb 7#bb ,u4,s4,c4 #bdab71 section #ae ( ! ,/ate ,dep>tm5t ,basic ,au?orities ,act ( #aief 7#bb ,u4,s4,c4 #bfhj71 section #cac ( ! ,=eign ,relations ,au?orization ,act1 ,fiscal ,ye>s #aiid & #aiie 7#bb ,u4,s4,c4 #fbab71 & section #ejd7;a77#a7 ( ! ,national ,security ,act ( #aidg 7#ej ,u4,s4,c4 #cjid7;a77#a774 #aad4 ,ea* am\nt incorporat$ by ref]5ce 9 ?is ,act t 0 previ\sly designat$ by ! ,congress z an em]g5cy requirem5t pursuant to sections #djja7;a77#a7 & #djja7;b7 ( ,s4 ,con4 ,res4 #ad 7#aag? ,congress71 ! concurr5t resolution on ! budget = fiscal ye> #bjbb1 or z be+ = disa/] relief pursuant to section #djje7;f7 ( su* concurr5t resolution1 is designat$ z be+ an em]g5cy requirem5t pursuant to section #djja7;a77#a7 ( su* concurr5t resolution & section #a7;e7 ( ,h4 ,res4 #aaea 7#aag? ,congress71 z engross$ 9 ! ,h\se ( ,repres5tatives on ,june #h1 #bjbb1 or z be+ = disa/] relief pursuant to section #a7;f7 ( su* ,h\se resolution1 respectively4 #aae4 7a7 ,rescissions or cancellations ( discretion>y budget au?ority t cont9ue pursuant to section #aja 9 ,treasury ,appropriations ,fund ,symbols 7,,tafs7-- 7#a7 to :i* o!r appropriations are n provid$ by ?is ,act1 b = :i* !re is a curr5t applicable ,,tafs t does receive an appropriation 9 ?is ,act2 or 7#b7 :i* are no-ye> ,,tafs & receive o!r appropriations 9 ?is ,act1 may be cont9u$ in/ead by r$uc+ ! rate = op]ations o!rwise provid$ by section #aja = su* curr5t applicable ,,tafs1 z long z do+ s does n imp+e on ! f9al fund+ pr]ogatives ( ! ,congress4 7b7 ,rescissions or cancellations describ$ 9 subsection 7a7 %all cont9ue 9 an am\nt equal to ! less] (-- 7#a7 ! am\nt specifi$ = rescission or cancellation 9 ! applicable appropriations ,act ref]5c$ 9 section #aja ( ?is ,act2 or 7#b7 ! am\nt ( balances available1 z ( ,octob] #a1 #bjbb1 f ! funds specifi$ = rescission or cancellation 9 ! applicable appropriations ,act ref]5c$ 9 section #aja ( ?is ,act4 7c7 ,no lat] ?an ,novemb] #ba1 #bjbb1 ! ,director ( ! ,(fice ( ,managem5t & ,budget %all provide to ! ,committees on ,appropriations ( ! ,h\se ( ,repres5tatives & ! ,s5ate a compreh5sive li/ ( ! rescissions or cancellations t w cont9ue pursuant to section #aja3 ,provid$1 ,t ! in=mation 9 su* compreh5sive li/ %all be p]iodically updat$ to reflect any subsequ5t *anges 9 ! am\nt ( balances available1 z ( ,octob] #a1 #bjbb1 f ! funds specifi$ = rescission or cancellation 9 ! applicable appropriations ,act ref]5c$ 9 section #aja1 & su* updates %all be transmitt$ to ! ,committees on ,appropriations ( ! ,h\se ( ,repres5tatives & ! ,s5ate ^u reque/4 #aaf4 ,am\nts made available by section #aja = ,f>m ,s]vice ,ag5cy--,agricultural ,cr$it ,insurance ,fund ,program ,acc\nt may be apportion$ up to ! rate = op]ations necess>y to accommodate approv$ applications = direct & gu>ante$ f>m own]%ip loans1 z au?oriz$ by #g ,u4,s4,c4 #aibb et seq4 #aag4 ,am\nts made available by section #aja to ! ,dep>tm5t ( ,agriculture = ,rural ,bus9ess--,coop]ative ,s]vice--,rural ,micro5trepr5eur ,assi/ance ,program may be us$ = ! co/s ( loans1 includ+ ! co/ ( modify+ su* loans1 z def9$ 9 section #ejb ( ! ,congressional ,budget ,act ( #aigd1 "u ! same t]ms & conditions z au?oriz$ by section #cgi;,e ( ! ,consolidat$ ,f>m & ,rural ,developm5t ,act 7#g ,u4,s4,c4 #bjjhs74 #aah4 ,section #bfj ( ! ,agricultural ,m>ket+ ,act ( #aidf 7#g ,u4,s4,c4 #afcf;i7 & section #idb ( ! ,live/ock ,m&atory ,report+ ,act ( #aiii 7#g ,u4,s4,c4 #afce note2 ,public ,law #ajf-gh7 %all be appli$ by sub/itut+ ! date specifi$ 9 section #ajf7c7 ( ?is ,act = ,septemb] #cj1 #bjbb4 #aai4 ,am\nts made available by section #aja to ! ,dep>tm5t ( ,comm]ce = ,economic ,developm5t ,adm9i/ration--,sal>ies & ,exp5ses may be apportion$ up to ! rate = op]ations necess>y to ma9ta9 ag5cy op]ations4 #abj4 ,am\nts made available by section #aja = ,dep>tm5t ( ,comm]ce--,national ,telecommunications & ,in=mation ,adm9i/ration--,sal>ies & ,exp5ses may be apportion$ up to ! rate = op]ations necess>y to ensure cont9u$ ov]sight ( public safety communications programs4 #aba4 ,9 addition to am\nts o!rwise provid$ by section #aja1 = ,dep>tm5t ( ,ju/ice--,f$]al ,bureau ( ,inve/igation--,sal>ies & ,exp5ses1 !re is appropriat$ #ae1cjj1jjj1 = an additional am\nt = fiscal ye> #bjbc1 to rema9 available until ,septemb] #cj1 #bjbc1 = inve/igative activities associat$ ) ,afghan resettlem5t op]ations3 ,provid$1 ,t su* am\nt is designat$ by ! ,congress z be+ = an em]g5cy requirem5t pursuant to section #djja7;a77#a7 ( ,s4 ,con4 ,res4 #ad 7#aag? ,congress71 ! concurr5t resolution on ! budget = fiscal ye> #bjbb1 & section #a7;e7 ( ,h4 ,res4 #aaea 7#aag? ,congress71 z engross$ 9 ! ,h\se ( ,repres5tatives on ,june #h1 #bjbb4 #abb4 7a7 ,not)/&+ sections #aja & #ajf1 ?r\gh ,septemb] #cj1 #bjbc1 ! ,secret>y ( ,def5se may transf] up to #c1jjj1jjj1jjj f unobligat$ balances f am\nts made available "u ! head+ ,dep>tm5t ( ,def5se--,op]ation & ,ma9t5ance--,ov]seas ,humanit>ian1 ,disa/]1 & ,civic ,aid 9 division ,c ( ,public ,law #aag-dc & division ,b ( ,public ,law #aag-gj to any appropriation acc\nt "u ! head+s ,dep>tm5t ( ,/ate & ,relat$ ,ag5cy--,dep>tm5t ( ,/ate--,adm9i/ration ( ,=eign ,affairs1 ,bilat]al ,economic ,assi/ance--,dep>tm5t ( ,/ate--,migration & ,refugee ,assi/ance1 & ,bilat]al ,economic ,assi/ance--,dep>tm5t ( ,/ate--,unit$ ,/ates ,em]g5cy ,refugee & ,migration ,assi/ance ,fund = support ( ,op]ation ,allies ,welcome or any successor op]ation3 ,provid$1 ,t ^u transf]1 su* funds %all be m]g$ ) ! appropriation to :i* su* funds are transf]r$ except t su* funds may be made available = su* purposes not)/&+ any requirem5t or limitation applicable to ! appropriation to :i* transf]r$1 includ+ sections #b7;c77#a7 & #b7;c77#b7 ( ! ,migration & ,refugee ,assi/ance ,act ( #aifb ) respect to ! ,unit$ ,/ates ,em]g5cy ,refugee & ,migration ,assi/ance ,fund & 9 sections #d7;a7 & #d7;b7 ( ! ,/ate ,dep>tm5t ,basic ,au?orities ,act ( #aief ) respect to funds transf]r$ to ! ,em]g5cies 9 ! ,diplomatic & ,consul> ,s]vice acc\nt3 ,provid$ fur!r1 ,t section #bbae ( title #aj1 ,unit$ ,/ates ,code1 %all n apply to a transf] ( funds "u ?is subsection3 ,provid$ fur!r1 ,t ! ex]cise ( ! au?ority ( ?is subsection %all be subject to prior consultation )1 & ! regul> notification proc$ures (1 ! ,committees on ,appropriations ( ! ,h\se ( ,repres5tatives & ! ,s5ate3 ,provid$ fur!r1 ,t any funds transf]r$ pursuant to ?is subsection t 7 previ\sly designat$ by ! ,congress z an em]g5cy requirem5t pursuant to ! concurr5t resolution on ! budget are designat$ by ! ,congress z be+ = an em]g5cy requirem5t pursuant to section #djja7;a77#a7 ( ,s4 ,con4 ,res4 #ad 7#aag? ,congress71 ! concurr5t resolution on ! budget = fiscal ye> #bjbb1 & section #a7;e7 ( ,h4 ,res4 #aaea 7#aag? ,congress71 z engross$ 9 ! ,h\se ( ,repres5tatives on ,june #h1 #bjbb4 7b7 ,n lat] ?an ,novemb] #a1 #bjbb & prior to any transf] ( funds pursuant to subsection 7a71 ! ,director ( ! ,(fice ( ,managem5t & ,budget %all provide to ! ,committees on ,appropriations ( ! ,h\se ( ,repres5tatives & ! ,s5ate a writt5 report on ,op]ation ,allies ,welcome or any successor op]ation3 ,provid$1 ,t su* report %all describe ! numb] & /atus ( ,afghans resid+ at ,dep>tm5t ( ,def5se & ,dep>tm5t ( ,/ate-manag$ facilities & any anticipat$ future arrivals at su* facilities2 ! /rategy & plan1 includ+ timel9e1 = adjudicat+ & relocat+ all ,afghans resid+ at ,dep>tm5t ( ,def5se or ov]seas civilian facilities & = ! transition ( op]ations & responsibilities "u ,op]ation ,allies ,welcome or any successor op]ation f ! ,dep>tm5t ( ,def5se to ! ,dep>tm5t ( ,/ate dur+ fiscal ye> #bjbc2 ! activities & responsibilities assign$ to ea* ,f$]al ag5cy involv$ 9 su* /rategy & plan2 & a sp5d plan1 conta9+ an e/imate ( ! co/s1 includ+ additional con/ruction & security co/s1 to be incurr$ by ea* su* ag5cy = c>ry+ out su* /rategy & plan1 & ! s\rces ( funds3 ,provid$ fur!r1 ,t prior to ! initial obligation ( funds transf]r$ to ! ,dep>tm5t ( ,/ate pursuant to subsection 7a71 ! ,secret>y ( ,/ate %all submit a report to su* ,committees detail+ ! roles & responsibilities ( ,dep>tm5t ( ,/ate bureaus & (fices 9 ,op]ation ,allies ,welcome or any successor op]ation4 #abc4 ,dur+ ! p]iod cov]$ by ?is ,act1 section #gad7;b77#b77;,b7 ( title #aj1 ,unit$ ,/ates ,code1 %all be appli$ by sub/itut+ ?ree ye>s = two ye>s4 #abd4 7a7 ,( ! rema9+ unobligat$ balances1 z ( ,septemb] #cj1 #bjbb1 f am\nts provid$ "u ! head+ ,afghani/an ,security ,=ces ,fund 9 title ,,ix ( division ,c ( ,public ,law #aaf-bfj1 #ajj1jjj1jjj is h]eby p]man5tly resc9d$1 & 9 addition to am\nts o!rwise provid$ by section #aja1 an am\nt ( additional new budget au?ority equival5t to ! am\nt resc9d$ pursuant to ?is subsection is h]eby appropriat$ on ,septemb] #cj1 #bjbb1 = an additional am\nt = fiscal ye> #bjbb1 to rema9 available until ,septemb] #cj1 #bjbe1 = ! same purposes & "u ! same au?orities provid$ "u su* head+ 9 ,public ,law #aaf-bfj1 9 addition to o!r funds z may be available = su* purposes4 7b7 7#a7 ,subject to p>agraph 7#b71 ?is section %all become effective imm$iately ^u enactm5t ( ?is ,act4 7#b7 ,if ?is ,act is enact$ aft] ,septemb] #cj1 #bjbb1 ?is section %all be appli$ z if x 7 9 effect on ,septemb] #cj1 #bjbb4 #abe4 ,9 addition to am\nts o!rwise provid$ by section #aja1 = ,corps ( ,eng9e]s--,civil--,con/ruction1 !re is appropriat$ #bj1jjj1jjj1 = an additional am\nt = fiscal ye> #bjbc1 to rema9 available until exp5d$1 = necess>y exp5ses relat$ to wat] & wa/ewat] infra/ructure "u section #bai ( ! ,wat] ,res\rces ,developm5t ,act ( #aiib 7#ajf ,/at4 #dhce73 ,provid$1 ,t su* am\nt is designat$ by ! ,congress z be+ = an em]g5cy requirem5t pursuant to section #djja7;a77#a7 ( ,s4 ,con4 ,res4 #ad 7#aag? ,congress71 ! concurr5t resolution on ! budget = fiscal ye> #bjbb1 & section #a7;e7 ( ,h4 ,res4 #aaea 7#aag? ,congress71 z engross$ 9 ! ,h\se ( ,repres5tatives on ,june #h1 #bjbb4 #abf4 7a7 ,dur+ ! p]iod cov]$ by ?is ,act1 title ,i ( ,public ,law #ajh-cfa 7! ,calf$ ,bay-,delta ,au?orization ,act7 7#aah ,/at4 #afha71 z am5d$ by section #bjd ( division ,d ( ,public ,law #aag-ajc1 %all be appli$ by sub/itut+ #bjbc = #bjbb ea* place x appe>s4 7b7 ,dur+ ! p]iod cov]$ by ?is ,act1 section #ajc7;f77#d77;,a7 ( title ,i ( ,public ,law #ajh-cfa 7! ,calf$ ,bay-,delta ,au?orization ,act7 7#aah ,/at4 #afif7 %all be appli$ by sub/itut+ #be1fej1jjj = #be1jjj1jjj4 #abg4 7a7 ,dur+ ! p]iod cov]$ by ?is ,act1 section #iajf7;g77#b7 ( ,public ,law #aaa-aa 7,omnibus ,public ,l& ,managem5t ,act ( #bjji7 %all be appli$ by sub/itut+ #bjbc = #bjbb4 7b7 ,dur+ ! p]iod cov]$ by ?is ,act1 section #ajd7;c7 ( ! ,reclamation ,/ates ,em]g5cy ,dr\ght ,relief ,act ( #aiia 7#dc ,u4,s4,c4 #bbad7;c77 %all be appli$ by sub/itut+ #bjbc = #bjbb4 7c7 ,dur+ ! p]iod cov]$ by ?is ,act1 section #cja ( ! ,reclamation ,/ates ,em]g5cy ,dr\ght ,relief ,act ( #aiia 7#dc ,u4,s4,c4 #bbda7 %all be appli$ by sub/itut+ #bjbc = #bjbb4 #abh4 ,9 addition to am\nts o!rwise provid$ by section #aja1 am\nts are provid$ = ,dep>tm5t ( ! ,treasury--,alcohol & ,tobacco ,tax & ,trade ,bureau--,sal>ies & ,exp5ses at a rate = op]ations ( #ad1ibi1jjj1 = an additional am\nt to adm9i/] ! ,craft ,bev]age ,mod]nization ,act import claims program1 z requir$ by ! ,taxpay] ,c]ta9ty & ,disa/] ,tax ,relief ,act ( #bjbj1 & su* am\nts may be apportion$ up to ! rate = op]ations necess>y to e/abli% & implem5t a new import claims program4 #abi4 ,not)/&+ section #aja1 title ,,ii ( division ,e ( ,public ,law #aag-ajc %all be appli$ by add+ ! foll[+ new head+ & appropriation language "u ! head+ 8,executive ,(fice ( ! ,presid5t & ,funds ,appropriat$ to ! ,presid5t03 ,(fice ( ! ,national ,cyb] ,director ,sal>ies & ,exp5ses ,= necess>y exp5ses ( ! ,(fice ( ! ,national ,cyb] ,director1 z au?oriz$ by section #ageb ( ! ,william ,m4 7,mac7 ,?ornb]ry ,national ,def5se ,au?orization ,act = ,fiscal ,ye> #bjba 7,public ,law #aaf-bhc71 #ba1jjj1jjj1 ( :i* n to exce$ #e1jjj %all be available = (ficial reception & repres5tation exp5ses4 4 #acj4 ,not)/&+ section #aja1 am\nts are provid$ = ,! ,judici>y--,c\rts ( ,appeals1 ,di/rict ,c\rts1 & ,o!r ,judicial ,s]vices--,fees ( ,jurors & ,commission]s at a rate = op]ations ( #ei1efe1jjj4 #aca4 ,9 addition to am\nts o!rwise provid$ by section #aja1 = ,! ,judici>y--,c\rts ( ,appeals1 ,di/rict ,c\rts1 & ,o!r ,judicial ,s]vices--,c\rt ,security1 !re is appropriat$ #aab1ejj1jjj1 = an additional am\nt = fiscal ye> #bjbc1 to rema9 available until exp5d$1 = security improvem5ts at ,unit$ ,/ates c\r?\ses & ,f$]al c\rt facilities3 ,provid$1 ,t n lat] ?an #ij days aft] ! date ( enactm5t ( ?is ,act1 & e #ij days !reaft] until all funds provid$ by ?is section h be5 exp5d$1 ! ,director ( ! ,adm9i/rative ,(fice ( ! ,unit$ ,/ates ,c\rts %all provide1 9 an appropriate =mat1 qu>t]ly reports on ! obligations & exp5ditures ( ! funds provid$ "u ?is section to ! ,committees on ,appropriations ( ! ,h\se ( ,repres5tatives & ! ,s5ate3 ,provid$ fur!r1 ,t su* am\nt is designat$ by ! ,congress z be+ = an em]g5cy requirem5t pursuant to section #djja7;a77#a7 ( ,s4 ,con4 ,res4 #ad 7#aag? ,congress71 ! concurr5t resolution on ! budget = fiscal ye> #bjbb1 & section #a7;e7 ( ,h4 ,res4 #aaea 7#aag? ,congress71 z engross$ 9 ! ,h\se ( ,repres5tatives on ,june #h1 #bjbb4 #acb4 ,not)/&+ any o!r provision ( ?is ,act1 except section #ajf1 ! ,di/rict ( ,columbia may exp5d local funds made available "u ! head+ ,di/rict ( ,columbia--,di/rict ( ,columbia ,funds = su* programs & activities "u ! ,di/rict ( ,columbia ,appropriations ,act1 #bjbb 7title ,,iv ( division ,e ( ,public ,law #aag-ajc7 at ! rate set =? 9 ! ,fiscal ,ye> #bjbc ,local ,budget ,act ( #bjbb 7,d4,c4 ,act #bd-dhf71 z modifi$ z ( ! date ( enactm5t ( ?is ,act4 #acc4 ,9 addition to am\nts o!rwise provid$ by section #aja1 am\nts are provid$ = ,small ,bus9ess ,adm9i/ration--,sal>ies & ,exp5ses at a rate = op]ations ( #bj1jjj1jjj1 = an additional am\nt = co/s associat$ ) ! e/abli%m5t & implem5tation ( a ,gov]nm5t-wide s]vice-disabl$ vet]an-own$ small bus9ess c]tification program )9 ! ,small ,bus9ess ,adm9i/ration1 z requir$ by section #cf ( ! ,small ,bus9ess ,act 7#ae ,u4,s4,c4 #feg;f7 & section #hfb ( ,public ,law #aaf-bhc3 ,provid$1 ,t su* am\nts may be apportion$ up to ! rate = op]ations necess>y to e/abli% & implem5t su* c]tification program3 ,provid$ fur!r1 ,t su* am\nts may be obligat$ 9 ! acc\nt & budget /ructure set =? 9 ,h4,r4 #hbid1 z pass$ by ! ,h\se ( ,repres5tatives on ,july #bj1 #bjbb4 #acd4 ,am\nts made available by section #aja = ,small ,bus9ess ,adm9i/ration--,bus9ess ,loans ,program ,acc\nt may be apportion$ up to ! rate = op]ations necess>y to accommodate increas$ dem& = commitm5ts = g5]al bus9ess loans au?oriz$ "u p>agraphs 7#a7 ?r\gh 7#ce7 ( section #g7;a7 ( ! ,small ,bus9ess ,act 7#ae ,u4,s4,c4 #fcf7;a771 = gu>antees ( tru/ c]tificates au?oriz$ by section #e7;g7 ( ! ,small ,bus9ess ,act 7#ae ,u4,s4,c4 #fcd7;g771 = commitm5ts to gu>antee loans "u section #ejc ( ! ,small ,bus9ess ,inve/m5t ,act ( #aieh 7#ae ,u4,s4,c4 #fig71 & = commitm5ts to gu>antee loans = deb5tures "u section #cjc7;b7 ( ! ,small ,bus9ess ,inve/m5t ,act ( #aieh 7#ae ,u4,s4,c4 #fhc7;b774 #ace4 ,am\nts made available by section #aja to ! ,dep>tm5t ( ,homel& ,security "u ! head+ ,f$]al ,em]g5cy ,managem5t ,ag5cy--,disa/] ,relief ,fund may be apportion$ up to ! rate = op]ations necess>y to c>ry out response & recov]y activities "u ! ,rob]t ,t4 ,/af=d ,disa/] ,relief & ,em]g5cy ,assi/ance ,act 7#db ,u4,s4,c4 #eaba et seq474 #acf4 ,not)/&+ sections #aja1 #ajd1 & #ajf1 to c>ry out ! ,h]mit's ,peak_/,calf ,canyon ,fire ,assi/ance ,act1 !re is appropriat$ #b1ejj1jjj1jjj1 to rema9 available until exp5d$1 to ! ,dep>tm5t ( ,homel& ,security = ,f$]al ,em]g5cy ,managem5t ,ag5cy--,h]mit's ,peak_/,calf ,canyon ,fire ,assi/ance ,acc\nt1 :i* %all be d]iv$ by transf] f am\nts made available "u ! head+ ,f$]al ,em]g5cy ,managem5t ,ag5cy--,disa/] ,relief ,fund 9 title ,,vi ( division ,b ( ! ,coronavirus ,aid1 ,relief1 & ,economic ,security ,act 7,public ,law #aaf-acf71 ( :i* #a1jjj1jjj %all be transf]r$ to ,(fice ( ! ,inspector ,g5]al--,op]ations & ,support = ov]sight ( activities au?oriz$ by ! ,h]mit's ,peak_/,calf ,canyon ,fire ,assi/ance ,act3 ,provid$1 ,t no am\nts may be d]iv$ f am\nts made available = major disa/]s decl>$ pursuant to ! ,rob]t ,t4 ,/af=d ,disa/] ,relief & ,em]g5cy ,assi/ance ,act 7#db ,u4,s4,c4 #eaba et seq473 ,provid$ fur!r1 ,t am\nts provid$ by ?is section %all be subject to ! same au?orities & conditions z if su* am\nts 7 provid$ by title ,,iii ( ! ,dep>tm5t ( ,homel& ,security ,appropriations ,act1 #bjbb 7division ,f ( ,public ,law #aag-ajc73 ,provid$ fur!r1 ,t n lat] ?an #ij days aft] ! date ( enactm5t ( ?is ,act1 & e #ij days !reaft] until all funds provid$ by ?is section h be5 exp5d$1 ! ,adm9i/rator ( ! ,f$]al ,em]g5cy ,managem5t ,ag5cy %all provide1 9 an appropriate =mat1 qu>t]ly reports to ! ,committees on ,appropriations ( ! ,s5ate & ! ,h\se ( ,repres5tatives on ! obligations & exp5ditures ( ! funds made available by ?is section3 ,provid$ fur!r1 ,t am\nts transf]r$ by ?is section t 7 previ\sly designat$ by ! ,congress z an em]g5cy requirem5t pursuant to ! ,balanc$ ,budget & ,em]g5cy ,deficit ,control ,act ( #aihe or a concurr5t resolution on ! budget are designat$ z an em]g5cy requirem5t pursuant to section #djja7;a77#a7 ( ,s4 ,con4 ,res4 #ad 7#aag? ,congress71 ! concurr5t resolution on ! budget = fiscal ye> #bjbb1 & section #a7;e7 ( ,h4 ,res4 #aaea 7#aag? ,congress71 z engross$ 9 ! ,h\se ( ,repres5tatives on ,june #h1 #bjbb4 #acg4 ,section #gjh7;b77#ac7 ( ! ,homel& ,security ,act ( #bjjb 7#f ,u4,s4,c4 #cdh7;b77#ac77 %all be appli$ by sub/itut+ ! date specifi$ 9 section #ajf7c7 ( ?is ,act = ,septemb] #cj1 #bjbb4 #ach4 ,dur+ ! p]iod cov]$ by ?is ,act1 section #hbb7;a7 ( ! ,homel& ,security ,act ( #bjjb 7#f ,u4,s4,c4 #chc7;a77 %all be appli$ by sub/itut+ #bjbc = #bjbb4 #aci4 7a7 ,sections #acji7;a7 & #acai ( ! ,national ,flood ,insurance ,act ( #aifh 7#db ,u4,s4,c4 #djaf7;a7 & #djbf7 %all be appli$ by sub/itut+ ! date specifi$ 9 section #ajf7c7 ( ?is ,act = ,septemb] #cj1 #bjbb4 7b7 7#a7 ,subject to p>agraph 7#b71 ?is section %all become effective imm$iately ^u enactm5t ( ?is ,act4 7#b7 ,if ?is ,act is enact$ aft] ,septemb] #cj1 #bjbb1 ?is section %all be appli$ z if x 7 9 effect on ,septemb] #cj1 #bjbb4 #adj4 ,section #hhj7;g7 ( ! ,national ,def5se ,au?orization ,act = ,fiscal ,ye> #bjag 7,public ,law #aad-cbh7 %all be appli$ by sub/itut+ ! date specifi$ 9 section #ajf7c7 ( ?is ,act = ,septemb] #cj1 #bjbb4 #ada4 ,section #baj;,g7i7 ( ! ,homel& ,security ,act ( #bjjb 7#f ,u4,s4,c4 #abdn7i77 %all be appli$ by sub/itut+ ! date specifi$ 9 section #ajf7c7 ( ?is ,act = ! date t is #d ye>s aft] ! date ( enactm5t ( ?is section4 #adb4 ,am\nts made available by section #aja = ,dep>tm5t ( ! ,int]ior--,national ,p>k ,s]vice--,national ,recreation & ,pres]vation = h]itage p>tn]%ip programs may be us$ to provide f9ancial assi/ance to any national h]itage area1 national h]itage corridor1 cultural h]itage corridor1 national h]itage p>tn]%ip1 national h]itage r\te1 national h]itage canalway1 & battlefields national hi/oric di/rict e/abli%$ z ( ,septemb] #a1 #bjbb1 not)/&+ any /atutory sunset provision t]m9at+ ! ,secret>y's au?ority to provide assi/ance to any su* area & not)/&+ any limitation on am\nts au?oriz$ to be appropriat$ ) respect to any su* area4 #adc4 ,am\nts made available by section #aja to ! ,dep>tm5t ( ! ,int]ior "u ! head+ ,work+ ,capital ,fund may be apportion$ up to ! rate = op]ations necess>y to implem5t ent]prise cyb]security safegu>ds4 #add4 7a7 ,9 addition to am\nts o!rwise provid$ by section #aja1 am\nts are provid$ = ,dep>tm5t ( ,heal? & ,human ,s]vices--,indian ,heal? ,s]vice--,indian ,heal? ,s]vices at a rate = op]ations ( #af1gba1jjj1 = an additional am\nt = co/s ( /aff+ & op]at+ facilities t 7 op5$1 r5ovat$1 or exp&$ 9 fiscal ye>s #bjbb & #bjbc1 & su* am\nts may be apportion$ up to ! rate = op]ations necess>y to /aff & op]ate su* facilities4 7b7 ,9 addition to am\nts o!rwise provid$ by section #aja1 am\nts are provid$ = ,dep>tm5t ( ,heal? & ,human ,s]vices--,indian ,heal? ,s]vice--,indian ,heal? ,facilities at a rate = op]ations ( #a1bja1jjj1 = an additional am\nt = co/s ( /aff+ & op]at+ facilities t 7 op5$1 r5ovat$1 or exp&$ 9 fiscal ye>s #bjbb & #bjbc1 & su* am\nts may be apportion$ up to ! rate = op]ations necess>y to /aff & op]ate su* facilities4 #ade4 ,9 addition to am\nts o!rwise provid$ by section #aja1 = ,dep>tm5t ( ,heal? & ,human ,s]vices--,sub/ance ,abuse & ,m5tal ,heal? ,s]vices ,adm9i/ration--,m5tal ,heal?1 !re is appropriat$ #fb1jjj1jjj1 = an additional am\nt = fiscal ye> #bjbc1 to rema9 available until ,septemb] #cj1 #bjbc1 = c>ry+ out #ihh ,suicide ,lifel9e activities & behavioral heal? crisis s]vices4 #adf4 ,9 addition to am\nts o!rwise provid$ by section #aja1 = ,dep>tm5t ( ,heal? & ,human ,s]vices--,adm9i/ration = ,*ildr5 & ,families--,l[ ,income ,home ,en]gy ,assi/ance1 !re is appropriat$ #a1jjj1jjj1jjj1 = an additional am\nt = fiscal ye> #bjbc1 to rema9 available until ,septemb] #cj1 #bjbc1 = mak+ paym5ts "u subsection 7b7 ( section #bfjb ( ! ,l[-,income ,home ,en]gy ,assi/ance ,act ( #aiha 7#db ,u4,s4,c4 #hfba et seq473 ,provid$1 ,t ( ! funds made available by ?is section1 #ejj1jjj1jjj %all be allocat$ z ?\gh ! total appropriation = su* paym5ts = fiscal ye> #bjbc 0 less ?an #a1ige1jjj1jjj3 ,provid$ fur!r1 ,t su* am\nt is designat$ by ! ,congress z be+ = an em]g5cy requirem5t pursuant to section #djja7;a77#a7 ( ,s4 ,con4 ,res4 #ad 7#aag? ,congress71 ! concurr5t resolution on ! budget = fiscal ye> #bjbb1 & section #a7;e7 ( ,h4 ,res4 #aaea 7#aag? ,congress71 z engross$ 9 ! ,h\se ( ,repres5tatives on ,june #h1 #bjbb4 #adg4 ,9 addition to am\nts o!rwise provid$ by section #aja1 = ,dep>tm5t ( ,heal? & ,human ,s]vices--,adm9i/ration = ,*ildr5 & ,families--,refugee & ,entrant ,assi/ance1 !re is appropriat$ #a1gge1jjj1jjj1 = an additional am\nt = fiscal ye> #bjbc1 to rema9 available until ,septemb] #cj1 #bjbe1 to c>ry out section #dfb ( ! ,homel& ,security ,act ( #bjjb & section #bce ( ! ,william ,wilb]=ce ,traffick+ ,victims ,protection ,reau?orization ,act ( #bjjh1 & = refugee & entrant assi/ance activities au?oriz$ by section #dad ( ! ,immigration & ,nationality ,act & section #eja ( ! ,refugee ,education ,assi/ance ,act ( #aihj3 ,provid$1 ,t su* am\nt is designat$ by ! ,congress z be+ = an em]g5cy requirem5t pursuant to section #djja7;a77#a7 ( ,s4 ,con4 ,res4 #ad 7#aag? ,congress71 ! concurr5t resolution on ! budget = fiscal ye> #bjbb1 & section #a7;e7 ( ,h4 ,res4 #aaea 7#aag? ,congress71 z engross$ 9 ! ,h\se ( ,repres5tatives on ,june #h1 #bjbb4 #adh4 ,not)/&+ section #aja1 ! fir/ p>agraph "u ! head+ ,social ,security ,adm9i/ration--,limitation on ,adm9i/rative ,exp5ses 9 title ,,iv ( division ,h ( ,public ,law #aag-ajc %all be appli$ by sub/itut+ #ac1fjb1ide1jjj = #ac1bjb1ide1jjj4 #adi4 7a7 ,dur+ ! p]iod cov]$ by ?is ,act1 subsection 7a77#a77;,a7 ( section #bejb ( ! ,afghani/an ,supplem5tal ,appropriations ,act1 #bjbb 7division ,c ( ,public ,law #aag-dc7 %all be appli$ by sub/itut+ ! date specifi$ 9 section #ajf7c7 = ,septemb] #cj1 #bjbb4 7b7 ,! am\nt provid$ by ?is section is designat$ z an em]g5cy requirem5t pursuant to section #djja7;a77#a7 ( ,s4 ,con4 ,res4 #ad 7#aag? ,congress71 ! concurr5t resolution on ! budget = fiscal ye> #bjbb1 & section #a7;e7 ( ,h4 ,res4 #aaea 7#aag? ,congress71 z engross$ 9 ! ,h\se ( ,repres5tatives on ,june #h1 #bjbb4 #aej4 ,activities au?oriz$ by "p ,a ( title ,,iv 7o!r ?an "u section #djc7;c7 or #dah7 & section #aajh7;b7 ( ! ,social ,security ,act %all cont9ue ?r\gh ! date specifi$ 9 section #ajf7c71 9 ! mann] au?oriz$ = fiscal ye> #bjbb1 & out ( any money 9 ! ,treasury ( ! ,unit$ ,/ates n o!rwise appropriat$1 !re are h]eby appropriat$ su* sums z may be necess>y = su* purpose4 #aea4 ,not)/&+ section #aja1 section #abf ( division ,j ( ,public ,law #aag-ajc %all be appli$ dur+ ! p]iod cov]$ by ?is ,act by sub/itut+ fiscal ye> #bjag & fiscal ye> #bjah = fiscal ye> #bjag4 #aeb4 ,not)/&+ section #aja1 am\nts are provid$ =-- 7#a7 ,dep>tm5t ( ,/ate & ,relat$ ,ag5cy--,dep>tm5t ( ,/ate--,adm9i/ration ( ,=eign ,affairs--,diplomatic ,programs at a rate = op]ations ( #i1bbh1ghi1jjj2 7#b7 ,bilat]al ,economic ,assi/ance--,funds ,appropriat$ to ! ,presid5t--,int]national ,disa/] ,assi/ance at a rate = op]ations ( #d1eee1dfj1jjj2 7#c7 ,bilat]al ,economic ,assi/ance--,funds ,appropriat$ to ! ,presid5t--,transition ,initiatives at a rate = op]ations ( #ajj1jjj1jjj2 7#d7 ,bilat]al ,economic ,assi/ance--,funds ,appropriat$ to ! ,presid5t--,assi/ance = ,europe1 ,eurasia & ,c5tral ,asia at a rate = op]ations ( #hej1jjj1jjj2 7#e7 ,bilat]al ,economic ,assi/ance--,dep>tm5t ( ,/ate--,migration & ,refugee ,assi/ance at a rate = op]ations ( #c1efb1ahh1jjj2 7#f7 ,int]national ,security ,assi/ance--,dep>tm5t ( ,/ate--,int]national ,n>cotics ,control & ,law ,en=cem5t at a rate = op]ations ( #a1dba1jjd1jjj2 & 7#g7 ,int]national ,security ,assi/ance--,funds ,appropriat$ to ! ,presid5t--,=eign ,milit>y ,f9anc+ ,program at a rate = op]ations ( #f1aij1dbd1jjj4 #aec4 ,dur+ ! p]iod cov]$ by ?is ,act1 section #egi ( ! ,multifamily ,assi/$ ,h\s+ ,re=m & ,af=dability ,act ( #aiig 7#db ,u4,s4,c4 #adcg;f note7 %all be appli$ by sub/itut+ #bjbc = #bjbb ea* place x appe>s4 #aed4 ,am\nts made available by section #aja to ! ,dep>tm5t ( ,h\s+ & ,urban ,developm5t = ,public & ,indian ,h\s+--,native ,hawaiian ,h\s+ ,loan ,gu>antee ,fund ,program ,acc\nt may be apportion$ up to ! rate = op]ations necess>y to accommodate dem& = commitm5ts to gu>antee loans z au?oriz$ by section #ahd;,a ( ! ,h\s+ & ,community ,developm5t ,act ( #aiib 7#ab ,u4,s4,c4 #agaez-#ac;b74 #aee4 ,9 addition to am\nts o!rwise provid$ by section #aja1 = ,dep>tm5t ( ,h\s+ & ,urban ,developm5t--,community ,plann+ & ,developm5t--,community ,developm5t ,fund1 !re is appropriat$ #b1jjj1jjj1jjj1 = an additional am\nt = fiscal ye> #bjbc1 to rema9 available until exp5d$1 = ! same purposes & "u ! same t]ms & conditions z funds appropriat$ "u su* head+ 9 title ,,viii ( ! ,disa/] ,relief ,supplem5tal ,appropriations ,act1 #bjbb 7division ,b ( ,public ,law #aag-dc71 except t su* am\nts %all be = major disa/]s t occurr$ 9 #bjba or #bjbb & ! f\r?1 tw5tie?1 & tw5ty-fir/ provisos "u su* head+ 9 su* ,act %all n apply3 ,provid$1 ,t am\nts made available "u ?is section & "u su* head+ 9 su* ,act may be us$ by a grantee to assi/ utilities z "p ( a disa/]-relat$ eligible activity "u section #aje7;a7 ( ! ,h\s+ & ,community ,developm5t ,act ( #aigd 7#db ,u4,s4,c4 #ecje7;a773 ,provid$ fur!r1 ,t su* am\nt is designat$ by ! ,congress z be+ = an em]g5cy requirem5t pursuant to section #djja7;a77#a7 ( ,s4 ,con4 ,res4 #ad 7#aag? ,congress71 ! concurr5t resolution on ! budget = fiscal ye> #bjbb1 & section #a7;e7 ( ,h4 ,res4 #aaea 7#aag? ,congress71 z engross$ 9 ! ,h\se ( ,repres5tatives on ,june #h1 #bjbb4 #aef4 ,not)/&+ section #ajf ( ?is ,act1 at any "t dur+ fiscal ye> #bjbc1 ! ,secret>y ( ,h\s+ & ,urban ,developm5t may transf] up to #a1cjj1jjj 9 unobligat$ balances f am\nts made available 9 prior ,acts "u ! head+ ,h\s+ ,programs--,project-,bas$ ,r5tal ,assi/ance to ,treasury ,appropriation ,fund ,symbol #hf ,x #jadh = ! liquidation ( obligations incurr$ 9 fiscal ye> #bjah 9 connection ) ! cont9u$ provision ( int]e/ r$uction paym5ts au?oriz$ "u section #bcf ( ! ,national ,h\s+ ,act 7#ab ,u4,s4,c4 #agaez-#a74 #aeg4 7a7 ,! rema9+ unobligat$ balances1 z ( ,septemb] #cj1 #bjbb1 f am\nts made available = ,dep>tm5t ( ,transportation--,(fice ( ! ,secret>y--,national ,infra/ructure ,inve/m5ts 9 title ,i ( division ,h ( ! ,fur!r ,consolidat$ ,appropriations ,act1 #bjbj 7,public ,law #aaf-id7 are h]eby p]man5tly resc9d$1 & 9 addition to am\nts o!rwise provid$ by section #aja1 an am\nt ( additional new budget au?ority equival5t to ! am\nt resc9d$ pursuant to ?is subsection is h]eby appropriat$ on ,septemb] #cj1 #bjbb1 = an additional am\nt = fiscal ye> #bjbb1 to rema9 available until ,septemb] #cj1 #bjbc1 & %all be available1 )\t additional competition1 = complet+ ! fund+ ( aw>ds made pursuant to ! fiscal ye> #bjbj national infra/ructure inve/m5ts program1 9 addition to o!r funds z may be available = su* purposes4 7b7 ,! rema9+ unobligat$ balances1 z ( ,septemb] #cj1 #bjbb1 f am\nts made available to ! ,dep>tm5t ( ,transportation 9 section #aje ( division ,l ( ! ,consolidat$ ,appropriations ,act1 #bjba 7,public ,law #aaf-bfj7 are h]eby p]man5tly resc9d$1 & 9 addition to am\nts o!rwise provid$ by section #aja1 an am\nt ( additional new budget au?ority equival5t to ! am\nt resc9d$ pursuant to ?is subsection is h]eby appropriat$ on ,septemb] #cj1 #bjbb1 = an additional am\nt = fiscal ye> #bjbb1 to rema9 available until ,septemb] #cj1 #bjbc1 & %all be available1 )\t additional competition1 = complet+ ! fund+ ( aw>ds made pursuant to ! fiscal ye> #bjai national infra/ructure inve/m5ts program1 9 addition to o!r funds z may be available = su* purposes4 7c7 7#a7 ,subject to p>agraph 7#b71 ?is section %all become effective imm$iately ^u enactm5t ( ?is ,act4 7#b7 ,if ?is ,act is enact$ aft] ,septemb] #cj1 #bjbb1 ?is section %all be appli$ z if x 7 9 effect on ,septemb] #cj1 #bjbb4 ,?is division may be cit$ z ! ,cont9u+ ,appropriations ,act1 #bjbc4 ,b ,ukra9e ,supplem5tal ,appropriations ,act1 #bjbc ,! foll[+ sums are appropriat$1 out ( any money 9 ! ,treasury n o!rwise appropriat$1 = ! fiscal ye> end+ ,septemb] #cj1 #bjbc1 & = o!r purposes1 namely3 ,i ,dep>tm5t ( ,def5se ,milit>y ,p]sonnel ,milit>y ,p]sonnel1 ,army ,= an additional am\nt = ,milit>y ,p]sonnel1 ,army1 #aaj1ajg1jjj1 to rema9 available until ,septemb] #cj1 #bjbc1 to respond to ! situation 9 ,ukra9e & = relat$ exp5ses4 ,milit>y ,p]sonnel1 ,navy ,= an additional am\nt = ,milit>y ,p]sonnel1 ,navy1 #dfb1jjj1 to rema9 available until ,septemb] #cj1 #bjbc1 to respond to ! situation 9 ,ukra9e & = relat$ exp5ses4 ,milit>y ,p]sonnel1 ,m>9e ,corps ,= an additional am\nt = ,milit>y ,p]sonnel1 ,m>9e ,corps1 #fjj1jjj1 to rema9 available until ,septemb] #cj1 #bjbc1 to respond to ! situation 9 ,ukra9e & = relat$ exp5ses4 ,milit>y ,p]sonnel1 ,air ,=ce ,= an additional am\nt = ,milit>y ,p]sonnel1 ,air ,=ce1 #aa1ehb1jjj1 to rema9 available until ,septemb] #cj1 #bjbc1 to respond to ! situation 9 ,ukra9e & = relat$ exp5ses4 ,op]ation & ,ma9t5ance ,op]ation & ,ma9t5ance1 ,army ,= an additional am\nt = ,op]ation & ,ma9t5ance1 ,army1 #fed1fif1jjj1 to rema9 available until ,septemb] #cj1 #bjbc1 to respond to ! situation 9 ,ukra9e & = relat$ exp5ses4 ,op]ation & ,ma9t5ance1 ,navy ,= an additional am\nt = ,op]ation & ,ma9t5ance1 ,navy1 #dcc1jce1jjj1 to rema9 available until ,septemb] #cj1 #bjbc1 to respond to ! situation 9 ,ukra9e & = relat$ exp5ses4 ,op]ation & ,ma9t5ance1 ,m>9e ,corps ,= an additional am\nt = ,op]ation & ,ma9t5ance1 ,m>9e ,corps1 #cd1ihd1jjj1 to rema9 available until ,septemb] #cj1 #bjbc1 to respond to ! situation 9 ,ukra9e & = relat$ exp5ses4 ,op]ation & ,ma9t5ance1 ,air ,=ce ,= an additional am\nt = ,op]ation & ,ma9t5ance1 ,air ,=ce1 #bfg1jhd1jjj1 to rema9 available until ,septemb] #cj1 #bjbc1 to respond to ! situation 9 ,ukra9e & = relat$ exp5ses4 ,op]ation & ,ma9t5ance1 ,space ,=ce ,= an additional am\nt = ,op]ation & ,ma9t5ance1 ,space ,=ce1 #a1gga1jjj1 to rema9 available until ,septemb] #cj1 #bjbc1 to respond to ! situation 9 ,ukra9e & = relat$ exp5ses4 ,op]ation & ,ma9t5ance1 ,def5se-,wide 7,includ+ ,transf] ( ,funds7 ,= an additional am\nt = ,op]ation & ,ma9t5ance1 ,def5se-,wide1 #d1gac1edd1jjj1 to rema9 available until ,septemb] #cj1 #bjbc1 to respond to ! situation 9 ,ukra9e & = relat$ exp5ses3 ,provid$1 ,t ( ! total am\nt provid$ "u ?is head+ 9 ?is ,act1 #c1jjj1jjj1jjj1 to rema9 available until ,septemb] #cj1 #bjbd1 %all be = ! ,ukra9e ,security ,assi/ance ,initiative3 ,provid$ fur!r1 ,t su* funds = ! ,ukra9e ,security ,assi/ance ,initiative %all be available to ! ,secret>y ( ,def5se "u ! same t]ms & conditions z are provid$ = 9 section #haci ( ! ,dep>tm5t ( ,def5se ,appropriations ,act1 #bjbb 7division ,c ( ,public ,law #aag-ajc73 ,provid$ fur!r1 ,t ( ! total am\nt provid$ "u ?is head+ 9 ?is ,act1 up to #a1ejj1jjj1jjj1 to rema9 available until ,septemb] #cj1 #bjbd1 may be transf]r$ to acc\nts "u ! head+s ,op]ation & ,ma9t5ance & ,procurem5t = replacem5t ( def5se articles f ! /ocks ( ! ,dep>tm5t ( ,def5se1 & = reimbursem5t = def5se s]vices ( ! ,dep>tm5t ( ,def5se & milit>y education & tra9+1 provid$ to ! gov]nm5t ( ,ukra9e or to =eign c\ntries t h provid$ support to ,ukra9e at ! reque/ ( ! ,unit$ ,/ates3 ,provid$ fur!r1 ,t funds transf]r$ pursuant to a transf] au?ority provid$ "u ?is head+ 9 ?is ,act %all be m]g$ ) & available = ! same purposes & = ! same "t p]iod z ! appropriations to :i* ! funds are transf]r$3 ,provid$ fur!r1 ,t ! ,secret>y ( ,def5se %all notify ! congressional def5se committees ( ! details ( su* transf]s n less ?an #ae days be=e any su* transf]3 ,provid$ fur!r1 ,t ^u a det]m9ation t all or "p ( ! funds transf]r$ f ?is appropriation are n necess>y = ! purposes provid$ h]e91 su* am\nts may be transf]r$ back & m]g$ ) ?is appropriation3 ,provid$ fur!r1 ,t ! transf] au?ority provid$ "u ?is head+ 9 ?is ,act is 9 addition to any o!r transf] au?ority provid$ by law4 ,procurem5t ,missile ,procurem5t1 ,army ,= an additional am\nt = ,missile ,procurem5t1 ,army1 #dej1jjj1jjj1 to rema9 available until ,septemb] #cj1 #bjbe1 to respond to ! situation 9 ,ukra9e & = relat$ exp5ses4 ,procurem5t ( ,ammunition1 ,army ,= an additional am\nt = ,procurem5t ( ,ammunition1 ,army1 #edj1jjj1jjj1 to rema9 available until ,septemb] #cj1 #bjbe1 = expansion ( public & private plants1 includ+ ! l& necess>y !re=1 & procurem5t & in/allation ( equipm5t1 appliances1 & ma*9e tools 9 su* plants1 = ! purpose ( increas+ production ( critical munitions to replace def5se articles provid$ to ! ,gov]nm5t ( ,ukra9e or =eign c\ntries t h provid$ support to ,ukra9e at ! reque/ ( ! ,unit$ ,/ates4 ,o!r ,procurem5t1 ,army ,= an additional am\nt = ,o!r ,procurem5t1 ,army1 #c1hij1jjj1 to rema9 available until ,septemb] #cj1 #bjbe1 to respond to ! situation 9 ,ukra9e & = relat$ exp5ses4 ,o!r ,procurem5t1 ,navy ,= an additional am\nt = ,o!r ,procurem5t1 ,navy1 #b1agj1jjj1 to rema9 available until ,septemb] #cj1 #bjbe1 to respond to ! situation 9 ,ukra9e & = relat$ exp5ses4 ,o!r ,procurem5t1 ,air ,=ce ,= an additional am\nt = ,o!r ,procurem5t1 ,air ,=ce1 #dcg1iia1jjj1 to rema9 available until ,septemb] #cj1 #bjbe1 to respond to ! situation 9 ,ukra9e & = o!r exp5ses4 ,procurem5t1 ,def5se-,wide ,= an additional am\nt = ,procurem5t1 ,def5se-,wide1 #i1ggj1jjj1 to rema9 available until ,septemb] #cj1 #bjbe1 to respond to ! situation 9 ,ukra9e & = relat$ exp5ses4 ,rese>*1 ,developm5t1 ,te/ & ,evaluation ,rese>*1 ,developm5t1 ,te/ & ,evaluation1 ,army ,= an additional am\nt = ,rese>*1 ,developm5t1 ,te/ & ,evaluation1 ,army1 #c1cjj1jjj1 to rema9 available until ,septemb] #cj1 #bjbd1 to respond to ! situation 9 ,ukra9e & = relat$ exp5ses4 ,rese>*1 ,developm5t1 ,te/ & ,evaluation1 ,navy ,= an additional am\nt = ,rese>*1 ,developm5t1 ,te/ & ,evaluation1 ,navy1 #b1jgg1jjj1 to rema9 available until ,septemb] #cj1 #bjbd1 to respond to ! situation 9 ,ukra9e & = relat$ exp5ses4 ,rese>*1 ,developm5t1 ,te/ & ,evaluation1 ,air ,=ce ,= an additional am\nt = ,rese>*1 ,developm5t1 ,te/ & ,evaluation1 ,air ,=ce1 #ii1gjd1jjj1 to rema9 available until ,septemb] #cj1 #bjbd1 to respond to ! situation 9 ,ukra9e & = relat$ exp5ses4 ,rese>*1 ,developm5t1 ,te/ & ,evaluation1 ,def5se-,wide ,= an additional am\nt = ,rese>*1 ,developm5t1 ,te/ & ,evaluation1 ,def5se-,wide1 #ca1bcj1jjj1 to rema9 available until ,septemb] #cj1 #bjbd1 to respond to ! situation 9 ,ukra9e & = relat$ exp5ses4 ,o!r ,dep>tm5t ( ,def5se ,programs ,(fice ( ! ,inspector ,g5]al ,= an additional am\nt = ,(fice ( ! ,inspector ,g5]al1 #b1jjj1jjj1 to rema9 available until ,septemb] #cj1 #bjbc1 to c>ry out reviews ( ! activities ( ! ,dep>tm5t ( ,def5se to execute funds appropriat$ 9 ?is title1 includ+ assi/ance provid$ to ,ukra9e3 ,provid$1 ,t ! ,inspector ,g5]al ( ! ,dep>tm5t ( ,def5se %all provide to ! congressional def5se committees a brief+ n lat] ?an #ij days aft] ! date ( enactm5t ( ?is ,act4 ,relat$ ,ag5cies ,intellig5ce ,community ,managem5t ,acc\nt ,= an additional am\nt = ,intellig5ce ,community ,managem5t ,acc\nt1 #ejj1jjj1 to rema9 available until ,septemb] #cj1 #bjbc1 to respond to ! situation 9 ,ukra9e & = relat$ exp5ses4 ,g5]al ,provisions--,?is ,title #aaja4 ,n lat] ?an #fj days aft] ! date ( enactm5t ( ?is ,act1 ! ,secret>y ( ,def5se1 9 coord9ation ) ! ,secret>y ( ,/ate1 %all submit a report to ! ,committees on ,appropriations1 ,arm$ ,s]vices1 & ,=eign ,affairs ( ! ,h\se ( ,repres5tatives & ! ,committees on ,appropriations1 ,arm$ ,s]vices1 & ,=eign ,relations ( ! ,s5ate on measures be+ tak5 to acc\nt = ,unit$ ,/ates def5se articles designat$ = ,ukra9e s9ce ! ,febru>y #bd1 #bjbb1 ,russian invasion ( ,ukra9e1 p>ticul>ly measures ) reg>d to su* articles t require enhanc$ end-use monitor+2 measures to ensure t su* articles rea* _! int5d$ recipi5ts & are us$ = _! int5d$ purposes2 & any o!r measures to promote acc\ntability = ! use ( su* articles3 ,provid$1 ,t su* report %all include a description ( any occurr5ces ( articles n rea*+ _! int5d$ recipi5ts or us$ = _! int5d$ purposes & a description ( any rem$ies tak53 ,provid$ fur!r1 ,t su* report %all be submitt$ 9 unclassifi$ =m1 b may be accompani$ by a classifi$ annex4 #aajb4 ,n lat] ?an #cj days aft] ! date ( enactm5t ( ?is ,act1 & e #cj days !reaft] ?r\gh fiscal ye> #bjbc1 ! ,secret>y ( ,def5se1 9 coord9ation ) ! ,secret>y ( ,/ate1 %all provide a writt5 report to ! ,committees on ,appropriations1 ,arm$ ,s]vices1 & ,=eign ,affairs ( ! ,h\se ( ,repres5tatives & ! ,committees on ,appropriations1 ,arm$ ,s]vices1 & ,=eign ,relations ( ! ,s5ate describ+ ,unit$ ,/ates security assi/ance provid$ to ,ukra9e s9ce ! ,febru>y #bd1 #bjbb1 ,russian invasion ( ,ukra9e1 includ+ a compreh5sive li/ ( ! def5se articles & s]vices provid$ to ,ukra9e & ! associat$ au?ority & fund+ us$ to provide su* articles & s]vices3 ,provid$1 ,t su* report %all be submitt$ 9 unclassifi$ =m1 b may be accompani$ by a classifi$ annex4 ,,ii ,dep>tm5t ( ,en]gy ,atomic ,en]gy ,def5se ,activities ,national ,nucle> ,security ,adm9i/ration ,def5se ,nucle> ,nonprolif]ation ,= an additional am\nt = ,def5se ,nucle> ,nonprolif]ation1 #ce1jjj1jjj1 to rema9 available until exp5d$1 to respond to ! situation 9 ,ukra9e & = relat$ exp5ses4 ,,iii ,bilat]al ,economic ,assi/ance ,funds ,appropriat$ to ! ,presid5t ,economic ,support ,fund ,= an additional am\nt = ,economic ,support ,fund1 #d1ejj1jjj1jjj1 to rema9 available until ,septemb] #cj1 #bjbd1 = assi/ance = ,ukra9e3 ,provid$1 ,t funds appropriat$ "u ?is head+ 9 ?is ,act may be made available not)/&+ any o!r provision ( law t re/ricts assi/ance to =eign c\ntries & may be made available z contributions4 ,g5]al ,provisions--,?is ,title #acja4 ,dur+ fiscal ye> #bjbc1 section #ejf7;a77#a7 ( ! ,=eign ,assi/ance ,act ( #aifa 7#bb ,u4,s4,c4 #bcah7;a77#a77 %all be appli$ by sub/itut+ #c1gjj1jjj1jjj = #ajj1jjj1jjj4 #acjb4 7a7 ,funds appropriat$ by ?is title %all be made available = direct f9ancial support = ! ,gov]nm5t ( ,ukra9e1 includ+ = ,ukra9ian fir/ respond]s1 & may be made available z a ca% transf] subject to ! requirem5ts ( subsection 7b73 ,provid$1 ,t su* funds %all be provid$ on a reimbursable basis & mat*$ by s\rces o!r ?an ! ,unit$ ,/ates ,gov]nm5t1 to ! maximum ext5t practicable3 ,provid$ fur!r1 ,t ! ,secret>y ( ,/ate or ! ,adm9i/rator ( ! ,unit$ ,/ates ,ag5cy = ,int]national ,developm5t1 z appropriate1 %all ensure ?ird-p>ty monitor+ ( su* funds3 ,provid$ fur!r1 ,t at lea/ #ae days prior to ! initial obligation ( su* funds1 ! ,secret>y ( ,/ate1 foll[+ consultation ) ! ,adm9i/rator ( ! ,unit$ ,/ates ,ag5cy = ,int]national ,developm5t1 %all c]tify & report to ! appropriate congressional committees t me*anisms = monitor+ & ov]sight ( su* funds are 9 place & function+ & t ! ,gov]nm5t ( ,ukra9e has 9 place sub/antial safegu>ds to prev5t corruption & ensure acc\ntability ( su* funds3 ,provid$ fur!r1 ,t n less ?an #de days aft] ! initial obligation ( su* funds1 ! ,inspectors ,g5]al ( ! ,dep>tm5t ( ,/ate & ! ,unit$ ,/ates ,ag5cy = ,int]national ,developm5t %all submit a report to ! appropriate congressional committees detail+ & assess+ ! me*anisms = monitor+ & safegu>ds describ$ 9 ! previ\s proviso4 7b7 ,funds made available to ! ,gov]nm5t ( ,ukra9e z a ca% transf] "u subsection 7a7 %all be subject to a memor&um ( und]/&+ betwe5 ! ,gov]nm5ts ( ! ,unit$ ,/ates & ,ukra9e t describes h[ ! funds propos$ to be made available w be us$ & ! appropriate safegu>ds to ensure transp>5cy & acc\ntability3 ,provid$1 ,t su* assi/ance %all be ma9ta9$ 9 a sep>ate1 auditable acc\nt & may n be com+l$ ) any o!r funds4 7c7 ,! ,secret>y ( ,/ate or ! ,adm9i/rator ( ! ,unit$ ,/ates ,ag5cy = ,int]national ,developm5t1 z appropriate1 %all report to ! appropriate congressional committees on ! uses ( funds provid$ = direct f9ancial support to ! ,gov]nm5t ( ,ukra9e pursuant to subsection 7a7 n lat] ?an #de days aft] ! date ( enactm5t ( ?is ,act & e #de days !reaft] until all su* funds h be5 exp5d$3 ,provid$1 ,t su* report %all include a detail$ description ( ! use ( su* funds1 includ+ categories & am\nts1 ! int5d$ results & ! results a*iev$1 a summ>y ( o!r donor contributions1 & a description ( ! ef=ts und]tak5 by ! ,secret>y & ,adm9i/rator to increase o!r donor contributions = direct f9ancial support3 ,provid$ fur!r1 ,t su* report %all also include ! metrics e/abli%$ to measure su* results4 7d7 ,funds made available = ! purposes ( subsection 7a7 %all be subject to ! regul> notification proc$ures ( ! ,committees on ,appropriations ( ! ,h\se ( ,repres5tatives & ! ,s5ate4 ,,iv ,g5]al ,provisions--,?is ,act #adja4 ,ea* am\nt appropriat$ or made available by ?is ,act is 9 addition to am\nts o!rwise appropriat$ = ! fiscal ye> involv$4 #adjb4 ,no "p ( any appropriation conta9$ 9 ?is ,act %all rema9 available = obligation beyond ! curr5t fiscal ye> unless expressly s provid$ h]e94 #adjc4 ,unless o!rwise provid$ = by ?is ,act1 ! additional am\nts appropriat$ by ?is ,act to appropriations acc\nts %all be available "u ! au?orities & conditions applicable to su* appropriations acc\nts = fiscal ye> #bjbc4 #adjd4 ,ea* am\nt provid$ by ?is division is designat$ by ! ,congress z be+ = an em]g5cy requirem5t pursuant to section #djja7;a77#a7 ( ,s4 ,con4 ,res4 #ad 7#aag? ,congress71 ! concurr5t resolution on ! budget = fiscal ye> #bjbb1 & section #a7;e7 ( ,h4 ,res4 #aaea 7#aag? ,congress71 z engross$ 9 ! ,h\se ( ,repres5tatives on ,june #h1 #bjbb4 ,?is division may be cit$ z ! ,ukra9e ,supplem5tal ,appropriations ,act1 #bjbc4 ,c ,o!r ,matt]s ,i ,ext5sions1 ,te*nical ,corrections1 & ,o!r ,matt]s #aja4 ,ext5sion ( ,,fcc ,auction ,au?ority ,section #cji7;j77#aa7 ( ! ,communications ,act ( #aicd 7#dg ,u4,s4,c4 #cji7;j77#aa77 is am5d$ by /rik+ ,septemb] #cj1 #bjbb & ins]t+ ,decemb] #af1 #bjbb4 #ajb4 ,ext5sion ( ,au?orization = ,special ,assessm5t = ,dome/ic ,traffick+ ,victims' ,fund ,section #cjad7;a7 ( title #ah1 ,unit$ ,/ates ,code1 is am5d$1 9 ! matt] prec$+ p>agraph 7#a71 by /rik+ ,septemb] #cj1 #bjbb & ins]t+ ,decemb] #af1 #bjbb4 #ajc4 ,unit$ ,/ates ,p>ole ,commission ,ext5sion 7a7 ,%ort ,title ,?is section may be cit$ z ! ,unit$ ,/ates ,p>ole ,commission ,ext5sion ,act ( #bjbb4 7b7 ,am5dm5t ( ,s5t5c+ ,re=m ,act ( #aihd ,= purposes ( section #bce7;b7 ( ! ,s5t5c+ ,re=m ,act ( #aihd 7#ah ,u4,s4,c4 #ceea note2 ,public ,law #ih-dgc2 #ih ,/at4 #bjcb71 z su* section relates to *apt] #caa ( title #ah1 ,unit$ ,/ates ,code1 & ! ,unit$ ,/ates ,p>ole ,commission1 ea* ref]5ce 9 su* section to #ce ye>s or #ce-ye> p]iod %all be deem$ a ref]5ce to #ce ye>s & #df days or #ce-ye> & #df-;day p]iod1 respectively4 #ajd4 ,ext5sion ( ,commodity ,futures ,trad+ ,commission ,cu/om] ,protection ,fund ,exp5ses ,acc\nt ,section #a7;b7 ( ,public ,law #aag-be 7#ace ,/at4 #big7 is am5d$ by /rik+ ,octob] #a1 #bjbb ea* place x appe>s & ins]t+ ,decemb] #af1 #bjbb4 ,,ii ,budget>y ,effects #bja4 ,budget>y ,effects 7a7 ,/atutory ,,paygo ,scorec>ds ,! budget>y effects ( ?is division & ea* succe$+ division %all n be ent]$ on ei!r ,,paygo scorec>d ma9ta9$ pursuant to section #d7;d7 ( ! ,/atutory ,pay-,z-,y-,g ,act ( #bjaj4 7b7 ,s5ate ,,paygo ,scorec>ds ,! budget>y effects ( ?is division & ea* succe$+ division %all n be ent]$ on any ,,paygo scorec>d ma9ta9$ = purposes ( section #dajf ( ,h4 ,con4 ,res4 #ga 7#aae? ,congress74 7c7 ,classification ( ,budget>y ,effects ,not)/&+ ,rule #c ( ! ,budget ,scorekeep+ ,guidel9es set =? 9 ! jo9t explanatory /atem5t ( ! committee ( conf]5ce accompany+ ,conf]5ce ,report #aje-bag & section #bej7;c77#h7 ( ! ,balanc$ ,budget & ,em]g5cy ,deficit ,control ,act ( #aihe1 ! budget>y effects ( ?is division & ea* succe$+ division %all n be e/imat$-- 7#a7 = purposes ( section #bea ( su* ,act2 7#b7 = purposes ( an allocation to ! ,committee on ,appropriations pursuant to section #cjb7;a7 ( ! ,congressional ,budget ,act ( #aigd2 & 7#c7 = purposes ( p>agraph 7#d77;,c7 ( section #c ( ! ,/atutory ,pay-,z-,y-,g ,act ( #bjaj z be+ includ$ 9 an appropriation ,act4 ,d ,heal? & ,human ,s]vices ,ext5sions ,i ,m$ic>e & ,m$icaid #aja4 ,ext5sion ( increas$ inpati5t hospital paym5t adju/m5t = c]ta9 l[-volume hospitals 7a7 ,9 g5]al ,section #ahhf7;d77#ab7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acieww7d77#ab77 is am5d$-- 7#a7 9 subp>agraph 7,b71 9 ! matt] prec$+ clause 7i71 by /rik+ 9 fiscal ye> #bjbc & subsequ5t fiscal ye>s & ins]t+ dur+ ! portion ( fiscal ye> #bjbc beg9n+ on ,decemb] #ag1 #bjbb1 & end+ on ,septemb] #cj1 #bjbc1 & 9 fiscal ye> #bjbd & subsequ5t fiscal ye>s2 7#b7 9 subp>agraph 7,c77i7-- 7,a7 9 ! matt] prec$+ subclause 7,i7-- 7i7 by ins]t+ or portion ( a fiscal ye> aft] = a fiscal ye>2 & 7ii7 by ins]t+ & ! portion ( fiscal ye> #bjbc beg9n+ on ,octob] #a1 #bjbb1 & end+ on ,decemb] #af1 #bjbb aft] ?r\gh #bjbb2 7,b7 9 subclause 7,,iii71 by ins]t+ & ! portion ( fiscal ye> #bjbc beg9n+ on ,octob] #a1 #bjbb1 & end+ on ,decemb] #af1 #bjbb aft] ?r\gh #bjbb2 & 7,c7 9 subclause 7,,iv71 by /rik+ fiscal ye> #bjbc & ins]t+ ! portion ( fiscal ye> #bjbc beg9n+ on ,decemb] #ag1 #bjbb1 & end+ on ,septemb] #cj1 #bjbc1 & fiscal ye> #bjbd2 & 7#c7 9 subp>agraph 7,d7-- 7,a7 9 ! matt] prec$+ clause 7i71 by ins]t+ or dur+ ! portion ( fiscal ye> #bjbc beg9n+ on ,octob] #a1 #bjbb1 & end+ on ,decemb] #af1 #bjbb aft] ?r\gh #bjbb2 & 7,b7 9 clause 7ii71 by ins]t+ & ! portion ( fiscal ye> #bjbc beg9n+ on ,octob] #a1 #bjbb1 & end+ on ,decemb] #af1 #bjbb aft] ?r\gh #bjbb4 7b7 ,implem5tation ,not)/&+ any o!r provision ( law1 ! ,secret>y ( ,heal? & ,human ,s]vices may implem5t ! provisions (1 includ+ ! am5dm5ts made by1 ?is section by program in/ruction or o!rwise4 #ajb4 ,ext5sion ( ! ,m$ic>e-dep5d5t hospital 7,,mdh7 program 7a7 ,9 g5]al ,section #ahhf7;d77#e77;,g7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acieww7d77#e77;,g77 is am5d$-- 7#a7 9 clause 7i71 by /rik+ ,octob] #a1 #bjbb & ins]t+ ,decemb] #ag1 #bjbb2 & 7#b7 9 clause 7ii77,,ii71 by /rik+ ,octob] #a1 #bjbb & ins]t+ ,decemb] #ag1 #bjbb4 7b7 ,con=m+ am5dm5ts 7#a7 ,ext5sion ( t>get am\nt ,section #ahhf7;b77#c77;,d7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acieww7b77#c77;,d77 is am5d$-- 7,a7 9 ! matt] prec$+ clause 7i71 by /rik+ ,octob] #a1 #bjbb & ins]t+ ,decemb] #ag1 #bjbb2 & 7,b7 9 clause 7iv71 by ins]t+ & ! portion ( fiscal ye> #bjbc beg9n+ on ,octob] #a1 #bjbb1 & end+ on ,decemb] #af1 #bjbb1 aft] ?r\gh fiscal ye> #bjbb4 7#b7 ,p]mitt+ hospitals to decl9e reclassification ,section #aceja7;e77#b7 ( ! ,omnibus ,budget ,reconciliation ,act ( #aiic 7#db ,u4,s4,c4 #acieww note7 is am5d$ by /rik+ or fiscal ye> #bjjj ?r\gh fiscal ye> #bjbb1 & ins]t+ fiscal ye> #bjjj ?r\gh fiscal ye> #bjbb1 or ! portion ( fiscal ye> #bjbc beg9n+ on ,octob] #a1 #bjbb1 & end+ on ,decemb] #af1 #bjbb4 #ajc4 ,ext5sion ( increas$ ,f,m,a,ps = ! t]ritories ,section #aije7;ff7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acif;d7ff77 is am5d$ by /rik+ ,decemb] #ac ea* place x appe>s & ins]t+ ,decemb] #af 9 ea* su* place4 #ajd4 ,r$uction ( ,m$ic>e ,improvem5t ,fund ,section #ahih7;b77#a7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acie;iii7b77#a77 is am5d$ by /rik+ #g1ejj1jjj1jjj & ins]t+ #g1cjh1jjj1jjj4 ,,ii ,human ,s]vices #bja4 ,ext5sion ( mat]nal1 infant1 & e>ly *ildhood home visit+ programs ,activities au?oriz$ by section #eaa ( ! ,social ,security ,act %all cont9ue ?r\gh ,decemb] #af1 #bjbb1 9 ! mann] au?oriz$ = fiscal ye> #bjbb1 & out ( any money 9 ! ,treasury ( ! ,unit$ ,/ates n o!rwise appropriat$1 !re is h]eby appropriat$ = su* purpose an am\nt equal to ! pro rata portion ( ! am\nt appropriat$ = su* activities = fiscal ye> #bjbb4 #bjb4 ,ext5sion ( *ild & family s]vices programs ,activities au?oriz$ by "p ,b ( title ,,iv ( ! ,social ,security ,act %all cont9ue ?r\gh ,decemb] #af1 #bjbb1 9 ! mann] au?oriz$ = fiscal ye> #bjbb1 & out ( any money 9 ! ,treasury ( ! ,unit$ ,/ates n o!rwise appropriat$1 !re are h]eby appropriat$ su* sums z may be necess>y = su* purpose4 ,,iii ,public ,heal? #cja4 ,ext5sion ( ! program to deem c]ta9 heal? pr(essional volunte]s employees ( ! ,public ,heal? ,s]vice "u c]ta9 circum/ances 7a7 ,9 g5]al ,section #bbd7q7 ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bcc7q77 is am5d$ by /rik+ p>agraph 7#f74 7b7 ,te*nical corrections ,section #bbd ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bcc7 is am5d$-- 7#a7 9 subsection 7g77#a77;,h77iv71 by /rik+ ?is section4 & ins]t+ ?is section742 7#b7 9 subsection 7k77#c71 by ins]t+ gov]n+ bo>d memb]s1 aft] (fic]s12 7#c7 9 subsection 7p77#g77;,a77i71 by mov+ ! m>g9 ( subclause 7,,ii7 #b ems to ! left2 & 7#d7 9 subsection 7q77#e77;,a71 by /rik+ & p>agraph 7#f74 #cjb4 ,ext5sion ( au?orization = a commission$ (fic] ( ! ,public ,heal? ,s]vice ,to accumulate excess annual leave ,= purposes ( annual leave accumulat$ 9 fiscal ye> #bjbb1 ! au?ority provid$ 9 section #bajf ( division ,c ( ,public ,law #aaf-aei 7#db ,u4,s4,c4 #baj-a note7 %all apply to su* leave by sub/itut+ #bjbb = #bjbj 9 subsections 7a7 & 7d77#b74 ,,iv ,indian ,heal? #dja4 ,ext5sion ( moratorium ,section #dbd7;a7 ( title ,,iv ( division ,g ( ,public ,law #aac-gf is am5d$ by /rik+ ,octob] #a1 #bjai & ins]t+ ,decemb] #af1 #bjbb4 ,e ,vet]ans ,affairs ,ext5sions ,i ,ext5sions ( au?orities relat+ to heal? c>e #aja4 ,ext5sion ( au?ority = collection ( copaym5ts = hospital c>e & nurs+ home c>e ,section #agaj7;f77#b77;,b7 ( title #ch1 ,unit$ ,/ates ,code1 is am5d$ by /rik+ ,septemb] #cj1 #bjbb & ins]t+ ,septemb] #cj1 #bjbd4 #ajb4 ,ext5sion ( requirem5t to provide nurs+ home c>e to c]ta9 vet]ans ) s]vice-connect$ disabilities ,section #agaj;,a7d7 ( title #ch1 ,unit$ ,/ates ,code1 is am5d$ by /rik+ ,septemb] #cj1 #bjbb & ins]t+ ,septemb] #cj1 #bjbd4 #ajc4 ,ext5sion ( au?ority to cont9ue ,,dod-,,va ,heal? ,c>e ,%>+ ,inc5tive ,fund ,section #haaa7;d77#c7 ( title #ch1 ,unit$ ,/ates ,code1 is am5d$ by /rik+ ,septemb] #cj1 #bjbc & ins]t+ ,septemb] #cj1 #bjbf4 #ajd4 ,ext5sion ( au?ority = jo9t ,dep>tm5t ( ,def5se-,dep>tm5t ( ,vet]ans ,affairs m$ical facility demon/ration fund ,section #agjd7;e7 ( ! ,national ,def5se ,au?orization ,act = ,fiscal ,ye> #bjaj 7,public ,law #aaa-hd2 #abc ,/at4 #begc71 z mo/ rec5tly am5d$ by section #gae ( ! ,national ,def5se ,au?orization ,act = ,fiscal ,ye> #bjbb 7,public ,law #aag-ha2 #ace ,/at4 #aghg71 is am5d$ by /rik+ ,septemb] #cj1 #bjbc & ins]t+ ,septemb] #cj1 #bjbd4 #aje4 ,ext5sion ( tempor>y expansion ( paym5ts & all[ances = b5efici>y travel 9 connection ) vet]ans receiv+ c>e f ,vet ,c5t]s ,section #ajd7;a7 ( ! ,honor+ ,am]ica's ,vet]ans & ,c>+ = ,camp ,lejeune ,families ,act ( #bjab 7,public ,law #aab-aed2 #abf ,/at4 #aafi71 z mo/ rec5tly am5d$ by section #c ( ! ,dep>tm5t ( ,vet]ans ,affairs ,expir+ ,au?orities ,act ( #bjba 7,public ,law #aag-db2 #ace ,/at4 #cdb71 is am5d$ by /rik+ ,septemb] #cj1 #bjbb & ins]t+ ,septemb] #cj1 #bjbc4 ,,ii ,ext5sions ( au?orities relat+ to b5efits #bja4 ,ext5sion ( au?ority to transport individuals to & f ,dep>tm5t ( ,vet]ans ,affairs facilities ,section #aaa;,a7a77#b7 ( title #ch1 ,unit$ ,/ates ,code1 is am5d$ by /rik+ ,septemb] #cj1 #bjbb & ins]t+ ,septemb] #cj1 #bjbd4 #bjb4 ,ext5sion ( au?ority to ma9ta9 regional (fice 9 ! ,republic ( ! ,philipp9es ,section #cae7;b7 ( title #ch1 ,unit$ ,/ates ,code1 is am5d$ by /rik+ ,septemb] #cj1 #bjbb & ins]t+ ,septemb] #cj1 #bjbd4 #bjc4 ,ext5sion ( au?ority = report on equitable relief provid$ due to adm9i/rative error ,section #ejc7;c7 ( title #ch1 ,unit$ ,/ates ,code1 is am5d$ by /rik+ ,decemb] #ca1 #bjbb & ins]t+ ,decemb] #ca1 #bjbd4 #bjd4 ,ext5sion ( au?ority to provide assi/ance = specially adapt$ h\s+ = disabl$ vet]ans resid+ tempor>ily 9 h\s+ own$ by a family memb] ,section #bajb;,a7e7 ( title #ch1 ,unit$ ,/ates ,code1 is am5d$ by /rik+ ,decemb] #ca1 #bjbb & ins]t+ ,decemb] #ca1 #bjbd4 #bje4 ,ext5sion ( specially adapt$ h\s+ assi/ive te*nology grant program ,section #bajh7;g7 ( title #ch1 ,unit$ ,/ates ,code1 is am5d$ by /rik+ ,septemb] #cj1 #bjbb & ins]t+ ,septemb] #cj1 #bjbd4 ,,iii ,ext5sions ( au?orities relat+ to homeless vet]ans #cja4 ,ext5sion ( au?orization ( appropriations = homeless vet]ans re9tegration programs ,section #bjba7;e77#a77;,f7 ( title #ch1 ,unit$ ,/ates ,code1 is am5d$ by /rik+ #bjbb & ins]t+ #bjbd4 #cjb4 ,ext5sion ( au?orization ( appropriations = homeless wom5 vet]ans & homeless vet]ans ) *ildr5 re9tegration grant program ,section #bjba;,a7f77#a7 ( title #ch1 ,unit$ ,/ates ,code1 is am5d$ by /rik+ #bjbb & ins]t+ #bjbd4 #cjc4 ,ext5sion ( au?ority = treatm5t & rehabilitation = s]i\sly m5tally ill & homeless vet]ans 7a7 ,g5]al treatm5t ,section #bjca7;b7 ( title #ch1 ,unit$ ,/ates ,code1 is am5d$ by /rik+ ,septemb] #cj1 #bjbb & ins]t+ ,septemb] #cj1 #bjbd4 7b7 ,additional s]vices at c]ta9 locations ,section #bjcc7;d7 ( su* title is am5d$ by /rik+ ,septemb] #cj1 #bjbb & ins]t+ ,septemb] #cj1 #bjbd4 #cjd4 ,ext5sion ( fund+ = f9ancial assi/ance = supportive s]vices = v l[-income vet]an families 9 p]man5t h\s+ ,section #bjdd7;e77#a77;,h7 ( title #ch1 ,unit$ ,/ates ,code1 is am5d$ by /rik+ & #bjbb & ins]t+ ?r\gh #bjbd4 #cje4 ,ext5sion ( fund+ = grant program = homeless vet]ans ) special ne$s ,section #bjfa7;d77#a7 ( title #ch1 ,unit$ ,/ates ,code1 is am5d$ by /rik+ #bjbb & ins]t+ #bjbd4 #cjf4 ,ext5sion ( au?ority = ! ,advisory ,committee on ,homeless ,vet]ans ,section #bjff7;d7 ( title #ch1 ,unit$ ,/ates ,code1 is am5d$ by /rik+ ,septemb] #cj1 #bjbb & ins]t+ ,septemb] #cj1 #bjbf4 ,,iv ,ext5sions ( o!r au?orities #dja4 ,ext5sion ( au?orization ( appropriations = mon?ly assi/ance all[ance "u ! ,(fice ( ,national ,vet]ans ,sports ,programs & ,special ,ev5ts ,section #cbb7;d77#d7 ( title #ch1 ,unit$ ,/ates ,code1 is am5d$ by /rik+ #bjbb & ins]t+ #bjbf4 #djb4 ,ext5sion & au?orization ( appropriations = adaptive sports programs = disabl$ vet]ans & memb]s ( ! ,arm$ ,=ces 7a7 ,au?orization ( appropriations ,subsection 7g77#a77;,b7 ( section #eba;,a ( title #ch1 ,unit$ ,/ates ,code1 is am5d$ by /rik+ & #bjbb & ins]t+ ?r\gh #bjbf4 7b7 ,ext5sion ,subsection 7l7 ( su* section is am5d$ by /rik+ #bjbb & ins]t+ #bjbf4 7c7 ,te*nical correction ,subsection 7g77#a77;,a7 ( su* section is am5d$ by /rik+ 4 = ea* ( fiscal ye>s #bjaj ?r\gh #bjbj4 #djc4 ,ext5sion ( ,advisory ,committee on ,m9ority ,vet]ans ,section #edd7;e7 ( title #ch1 ,unit$ ,/ates ,code1 is am5d$ by /rik+ ,septemb] #cj1 #bjbb & ins]t+ ,septemb] #cj1 #bjbf4 #djd4 ,ext5sion ( ,vet]ans' ,advisory ,committee on ,education ,section #cfib7;c7 ( title #ch1 ,unit$ ,/ates ,code1 is am5d$ by /rik+ ,decemb] #ca1 #bjbb & ins]t+ ,decemb] #ca1 #bjbf4 #dje4 ,ext5sion ( au?ority = transf] ( real prop]ty ,section #haah7;a77#e7 ( title #ch1 ,unit$ ,/ates ,code1 is am5d$ by /rik+ ,septemb] #cj1 #bjbb & ins]t+ ,septemb] #cj1 #bjbd4 ,f ,,fda ,us] ,fee ,reau?orization ,act ( #bjbb #a4 ,%ort title ,?is division may be cit$ z ! ,,fda ,us] ,fee ,reau?orization ,act ( #bjbb4 #b4 ,table ( cont5ts ,! table ( cont5ts = ?is division is z foll[s3 ,,division ,f--,,fda ,us] ,fee ,reau?orization ,act ( #bjbb,sec4 #a4 ,%ort title4,sec4 #b4 ,table ( cont5ts4,,title ,i--,fees ,relat+ to ,drugs,sec4 #ajja4 ,%ort title2 f9d+4,sec4 #ajjb4 ,def9itions4,sec4 #ajjc4 ,au?ority to assess & use drug fees4,sec4 #ajjd4 ,reau?orization2 report+ requirem5ts4,sec4 #ajje4 ,sunset dates4,sec4 #ajjf4 ,effective date4,sec4 #ajjg4 ,sav+s clause4,,title ,,ii--,fees ,relat+ to ,devices,sec4 #bjja4 ,%ort title2 f9d+4,sec4 #bjjb4 ,def9itions4,sec4 #bjjc4 ,au?ority to assess & use device fees4,sec4 #bjjd4 ,reau?orization2 report+ requirem5ts4,sec4 #bjje4 ,con=mity assessm5t pilot program4,sec4 #bjjf4 ,reau?orization ( ?ird-p>ty review program4,sec4 #bjjg4 ,sunset dates4,sec4 #bjjh4 ,effective date4,sec4 #bjji4 ,sav+s clause4,,title ,,iii--,fees ,relat+ to ,g5]ic ,drugs,sec4 #cjja4 ,%ort title2 f9d+4,sec4 #cjjb4 ,au?ority to assess & use human g5]ic drug fees4,sec4 #cjjc4 ,reau?orization2 report+ requirem5ts4,sec4 #cjjd4 ,sunset dates4,sec4 #cjje4 ,effective date4,sec4 #cjjf4 ,sav+s clause4,,title ,,iv--,fees ,relat+ to ,biosimil> ,biological ,products,sec4 #djja4 ,%ort title2 f9d+4,sec4 #djjb4 ,def9itions4,sec4 #djjc4 ,au?ority to assess & use biosimil> biological product fees4,sec4 #djjd4 ,reau?orization2 report+ requirem5ts4,sec4 #djje4 ,sunset dates4,sec4 #djjf4 ,effective date4,sec4 #djjg4 ,sav+s clause4,,title ,v--,reau?orization ( o!r provisions,sec4 #ejja4 ,reau?orization ( ! be/ ph>maceuticals = *ildr5 program4,sec4 #ejjb4 ,reau?orization ( ! humanit>ian device exemption inc5tive4,sec4 #ejjc4 ,reau?orization ( ! p$iatric device consortia program4,sec4 #ejjd4 ,reau?orization ( provision p]ta9+ to drugs conta9+ s+le enantiom]s4,sec4 #ejje4 ,reau?orization ( ! critical pa? public-private p>tn]%ip4,sec4 #ejjf4 ,reau?orization ( orphan drug grants4,sec4 #ejjg4 ,reau?orization ( c]ta9 device inspections4,sec4 #ejjh4 ,reau?orization ( report+ requirem5ts relat$ to p5d+ g5]ic drug applications & priority review applications4 ,i ,fees ,relat+ to ,drugs #ajja4 ,%ort title2 f9d+ 7a7 ,%ort ,title ,?is title may be cit$ z ! ,prescription ,drug ,us] ,fee ,am5dm5ts ( #bjbb4 7b7 ,f9d+ ,congress f9ds t ! fees au?oriz$ by ! am5dm5ts made by ?is title w be d$icat$ t[>d exp$it+ ! drug developm5t process & ! process = ! review ( human drug applications1 includ+ po/m>ket drug safety activities1 z set =? 9 ! goals id5tifi$ = purposes ( "p #b ( sub*apt] ,c ( *apt] ,,vii ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;g et seq471 9 ! lett]s f ! ,secret>y ( ,heal? & ,human ,s]vices to ! ,*airman ( ! ,committee on ,heal?1 ,education1 ,labor1 & ,p5sions ( ! ,s5ate & ! ,*airman ( ! ,committee on ,en]gy & ,comm]ce ( ! ,h\se ( ,repres5tatives1 z set =? 9 ! ,congressional ,record4 #ajjb4 ,def9itions 7a7 ,human drug application ,section #gce7a7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;g7#a77 is am5d$1 9 ! matt] foll[+ subp>agraph 7,b71 by /rik+ an all]g5ic extract product1 or & ins]t+ does n include an application ) respect to an all]g5ic extract product lic5s$ be=e ,octob] #a1 #bjbb1 does n include an application ) respect to a /&>diz$ all]g5ic extract product submitt$ pursuant to a notification to ! applicant f ! ,secret>y reg>d+ ! exi/5ce ( a pot5cy te/ t measures ! all]g5ic activity ( an all]g5ic extract product lic5s$ by ! applicant be=e ,octob] #a1 #bjbb1 does n include an application ) respect to4 7b7 ,prescription drug product ,section #gce7c7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;g7#c77 is am5d$-- 7#a7 by r$esignat+ subp>agraphs 7,a71 7,b71 & 7,c7 z clauses 7i71 7ii71 & 7iii71 respectively2 7#b7 by /rik+ 7#c7 ,! t]m & ins]t+ 7#c77;,a7 ,! t]m2 7#c7 by /rik+ ,su* t]m does n include :ole blood & ins]t+ ! foll[+3 7,b7 ,su* t]m does n include :ole blood 2 7#d7 by /rik+ an all]g5ic extract product1 & ins]t+ an all]g5ic extract product lic5s$ be=e ,octob] #a1 #bjbb1 a /&>diz$ all]g5ic extract product submitt$ pursuant to a notification to ! applicant f ! ,secret>y reg>d+ ! exi/5ce ( a pot5cy te/ t measures ! all]g5ic activity ( an all]g5ic extract product lic5s$ by ! applicant be=e ,octob] #a1 #bjbb12 & 7#e7 by add+ at ! end ! foll[+3 7,c7 7i7 ,if a writt5 reque/ to place a product 9 ! discont9u$ section ( ei!r ( ! li/s ref]5c$ 9 subp>agraph 7,a77iii7 is submitt$ to ! ,secret>y on behalf ( an applicant1 & ! reque/ id5tifies ! date ! product is1 or w be1 )drawn f sale1 !n = purposes ( assess+ ! prescription drug program fee "u section #gcf7;a77#b71 ! ,secret>y %all consid] su* product to h be5 includ$ 9 ! discont9u$ section on ! lat] (-- 7,i7 ! date su* reque/ 0 receiv$2 or 7,,ii7 if ! product w be )drawn f sale on a future date1 su* future date :5 ! product is )drawn f sale4 7ii7 ,= purposes ( ?is subp>agraph1 a product %all be consid]$ )drawn f sale once ! applicant has ceas$ its own di/ribution ( ! product1 :e!r or n ! applicant has ord]$ recall ( all previ\sly di/ribut$ lots ( ! product1 except t a r\t9e1 tempor>y int]ruption 9 supply %all n r5d] a product )drawn f sale4 4 7c7 ,sk9-,te/ diagno/ic product ,section #gce ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;g7 is am5d$ by add+ at ! end ! foll[+3 7#ab7 ,! t]m sk9-te/ diagno/ic product-- 7,a7 means a product-- 7i7 = prick1 scrat*1 intrad]mal1 or subcutane\s adm9i/ration2 7ii7 expect$ to produce a limit$1 local reaction at ! site ( adm9i/ration 7if positive71 r ?an a sy/emic effect2 7iii7 n int5d$ to be a prev5tive or !rapeutic int]v5tion2 & 7iv7 int5d$ to detect an imm$iate- or delay$-type sk9 hyp]s5sitivity reaction to aid 9 ! diagnosis (-- 7,i7 an all]gy to an antimicrobial ag5t2 7,,ii7 an all]gy t is n to an antimicrobial ag5t1 if ! diagno/ic product 0 au?oriz$ = m>ket+ prior to ,octob] #a1 #bjbb2 or 7,,iii7 infection ) fungal or mycobact]ial pa?og5s2 & 7,b7 includes positive & negative controls requir$ to int]pret ! results ( a product describ$ 9 subp>agraph 7,a74 4 #ajjc4 ,au?ority to assess & use drug fees 7a7 ,types ( fees 7#a7 ,human drug application fee ,section #gcf7;a7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;h7a77 is am5d$-- 7,a7 9 ! matt] prec$+ p>agraph 7#a71 by /rik+ fiscal ye> #bjah & ins]t+ fiscal ye> #bjbc2 7,b7 9 p>agraph 7#a77;,a71 by /rik+ 7c77#e7 ea* place x appe>s & ins]t+ 7c77#f72 7,c7 9 p>agraph 7#a77;,c71 by ins]t+ prior to approval aft] or 0 )drawn2 & 7,d7 9 p>agraph 7#a71 by add+ at ! end ! foll[+3 7,h7 ,exception = sk9-te/ diagno/ic products ,a human drug application = a sk9-te/ diagno/ic product %all n be subject to a fee "u subp>agraph 7,a74 4 7#b7 ,prescription drug program fee ,section #gcf7;a77#b7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;h7a77#b77 is am5d$-- 7,a7 9 subp>agraph 7,a7-- 7i7 by /rik+ ,except z provid$ 9 subp>agraphs 7,b7 & 7,c7 & ins]t+ ! foll[+3 7i7 ,paym5t ( fees ,except z provid$ 9 subp>agraphs 7,b7 & 7,c7 2 7ii7 by /rik+ subsection 7c77#e7 & ins]t+ subsection 7c77#f72 & 7iii7 by add+ at ! end ! foll[+3 7ii7 ,special rule = previ\sly discont9u$ drug products ,if a drug product t is id5tifi$ 9 a human drug application approv$ z ( ,octob] #a ( a fiscal ye> is n a prescription drug product z ( t date because ! drug product is 9 ! discont9u$ section ( a li/ ref]5c$ 9 section #gce7c77;,a77iii71 & on any subsequ5t day dur+ su* fiscal ye> ! drug product is a prescription drug product1 !n except z provid$ 9 subp>agraphs 7,b7 & 7,c71 ea* p]son :o is nam$ z ! applicant 9 a human drug application ) respect to su* product1 & :o1 aft] ,septemb] #a1 #aiib1 _h p5d+ be=e ! ,secret>y a human drug application or supplem5t1 %all pay ! annual prescription drug program fee e/abli%$ = a fiscal ye> "u subsection 7c77#f7 = su* prescription drug product4 ,su* fee %all be due on ! la/ bus9ess day ( su* fiscal ye> & %all be paid only once = ea* su* product = a fiscal ye> 9 :i* ! fee is payable4 2 & 7,b7 by am5d+ subp>agraph 7,b7 to read z foll[s3 7,b7 ,exception = c]ta9 prescription drug products ,a prescription drug program fee %all n be assess$ = a prescription drug product "u subp>agraph 7,a7 if su* product is-- 7i7 a l>ge volume p>5t]al product 7a /]ile aque\s drug product packag$ 9 a s+le-dose conta9] ) a volume great] ?an or equal to #ajj m,l1 n includ+ p[d]s = recon/itution or ph>macy bulk packages7 id5tifi$ on ! li/ compil$ "u section #eje7;j77#g72 7ii7 ph>maceutically equival5t 7z def9$ 9 section #cad4c ( title #ba1 ,code ( ,f$]al ,regulations 7or any successor regulation77 to ano!r product on ! li/ ( products compil$ "u section #eje7;j77#g7 7n includ+ ! discont9u$ section ( su* li/72 or 7iii7 a sk9-te/ diagno/ic product4 4 7b7 ,fee rev5ue am\nts 7#a7 ,9 g5]al ,p>agraph 7#a7 ( section #gcf7;b7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;h7b77 is am5d$ to read z foll[s3 7#a7 ,9 g5]al ,= ea* ( ! fiscal ye>s #bjbc ?r\gh #bjbg1 fees "u subsection 7a7 %all1 except z provid$ 9 subsections 7c71 7d71 7f71 & 7g71 be e/abli%$ to g5]ate a total rev5ue am\nt "u su* subsection t is equal to ! sum (-- 7,a7 ! annual base rev5ue = ! fiscal ye> 7z det]m9$ "u p>agraph 7#c772 7,b7 ! doll> am\nt equal to ! inflation adju/m5t = ! fiscal ye> 7z det]m9$ "u subsection 7c77#a772 7,c7 ! doll> am\nt equal to ! /rategic hir+ & ret5tion adju/m5t = ! fiscal ye> 7z det]m9$ "u subsection 7c77#b772 7,d7 ! doll> am\nt equal to ! capacity plann+ adju/m5t = ! fiscal ye> 7z det]m9$ "u subsection 7c77#c772 7,e7 ! doll> am\nt equal to ! op]at+ res]ve adju/m5t = ! fiscal ye>1 if applicable 7z det]m9$ "u subsection 7c77#d772 7,f7 ! doll> am\nt equal to ! additional direct co/ adju/m5t = ! fiscal ye> 7z det]m9$ "u subsection 7c77#e772 & 7,g7 additional doll> am\nts = ea* fiscal ye> z foll[s3 7i7 #fe1ggc1fic = fiscal ye> #bjbc4 7ii7 #be1jig1fga = fiscal ye> #bjbd4 7iii7 #ad1aed1afi = fiscal ye> #bjbe4 7iv7 #d1hfd1hfj = fiscal ye> #bjbf4 7v7 #a1cad1fbj = fiscal ye> #bjbg4 4 7#b7 ,annual base rev5ue ,p>agraph 7#c7 ( section #gcf7;b7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;h7b77 is am5d$ to read z foll[s3 7#c7 ,annual base rev5ue ,= purposes ( p>agraph 7#a71 ! doll> am\nt ( ! annual base rev5ue = a fiscal ye> %all be-- 7,a7 = fiscal ye> #bjbc1 #a1aea1ebb1ieh2 & 7,b7 = fiscal ye>s #bjbd ?r\gh #bjbg1 ! doll> am\nt ( ! total rev5ue am\nt e/abli%$ "u p>agraph 7#a7 = ! previ\s fiscal ye>1 n includ+ any adju/m5ts made "u subsection 7c77#d7 or 7c77#e74 4 7c7 ,adju/m5ts2 annual fee sett+ 7#a7 ,inflation adju/m5t ,section #gcf7;c77#a77;,b77ii7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;h7c77#a77;,b77ii77 is am5d$ by /rik+ ,wa%+ton-,baltimore1 ,,dc-,,md-,,va-,,wv & ins]t+ ,wa%+ton-,arl+ton-,alex&ria1 ,,dc-,,va-,,md-,,wv4 7#b7 ,/rategic hir+ & ret5tion adju/m5t ,section #gcf7;c7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;h7c77 is am5d$-- 7,a7 by r$esignat+ p>agraphs 7#b7 ?r\gh 7#f7 z p>agraphs 7#c7 ?r\gh 7#g71 respectively2 & 7,b7 by ins]t+ aft] p>agraph 7#a7 ! foll[+3 7#b7 ,/rategic hir+ & ret5tion adju/m5t ,= ea* fiscal ye>1 aft] ! annual base rev5ue e/abli%$ 9 subsection 7b77#a77;,a7 is adju/$ = inflation 9 accordance ) p>agraph 7#a71 ! ,secret>y %all fur!r increase ! fee rev5ue & fees by ! foll[+ am\nts3 7,a7 ,= fiscal ye> #bjbc1 #i1jjj1jjj4 7,b7 ,= ea* ( fiscal ye>s #bjbd ?r\gh #bjbg1 #d1jjj1jjj4 4 7#c7 ,capacity plann+ adju/m5t ,p>agraph 7#c71 z r$esignat$1 ( section #gcf7;c7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;h7c77 is am5d$ to read z foll[s3 7#c7 ,capacity plann+ adju/m5t 7,a7 ,9 g5]al ,= ea* fiscal ye>1 aft] ! annual base rev5ue e/abli%$ 9 subsection 7b77#a77;,a7 is adju/$ 9 accordance ) p>agraphs 7#a7 & 7#b71 su* rev5ue %all be adju/$ fur!r = su* fiscal ye>1 9 accordance ) ?is p>agraph1 to reflect *anges 9 ! res\rce capacity ne$s ( ! ,secret>y = ! process = ! review ( human drug applications4 7,b7 ,me?odology ,= purposes ( ?is p>agraph1 ! ,secret>y %all employ ! capacity plann+ me?odology utiliz$ by ! ,secret>y 9 sett+ fees = fiscal ye> #bjba1 z describ$ 9 ! notice titl$ ,prescription ,drug ,us] ,fee ,rates = ,fiscal ,ye> #bjba publi%$ 9 ! ,f$]al ,regi/] on ,augu/ #c1 #bjbj 7#he ,f$4 ,reg4 #dffea74 ,! workload categories us$ 9 apply+ su* me?odology 9 =eca/+ %all include only ! activities describ$ 9 t notice &1 z feasible1 additional activities t are directly relat$ to ! direct review ( applications & supplem5ts1 includ+ additional =mal meet+ types1 ! direct review ( po/m>ket+ commitm5ts & requirem5ts1 ! direct review ( risk evaluation & mitigation /rategies1 & ! direct review ( annual reports = approv$ prescription drug products4 ,subject to ! exceptions 9 ! prec$+ s5t5ce1 ! ,secret>y %all n include z workload categories 9 apply+ su* me?odology 9 =eca/+ any non-core review activities1 includ+ ^? activities t ! ,secret>y ref]5c$ = pot5tial future use 9 su* notice b did n utilize 9 sett+ fees = fiscal ye> #bjba4 7,c7 ,limitation ,"u no circum/ances %all an adju/m5t "u ?is p>agraph result 9 fee rev5ue = a fiscal ye> t is less ?an ! sum ( ! am\nts "u subsections 7b77#a77;,a7 7! annual base rev5ue = ! fiscal ye>71 7b77#a77;,b7 7! doll> am\nt ( ! inflation adju/m5t = ! fiscal ye>71 & 7b77#a77;,c7 7! doll> am\nt ( ! /rategic hir+ & ret5tion adju/m5t = ! fiscal ye>74 7,d7 ,publication 9 ,f$]al ,regi/] ,! ,secret>y %all publi% 9 ! ,f$]al ,regi/] notice "u p>agraph 7#f7 ( ! fee rev5ue & fees result+ f ! adju/m5t & ! me?odologies "u ?is p>agraph4 4 7#d7 ,op]at+ res]ve adju/m5t ,p>agraph 7#d71 z r$esignat$1 ( section #gcf7;c7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;h7c77 is am5d$-- 7,a7 by am5d+ subp>agraph 7,a7 to read z foll[s3 7,a7 ,increase ,= fiscal ye> #bjbc & subsequ5t fiscal ye>s1 ! ,secret>y %all1 9 addition to adju/m5ts "u p>agraphs 7#a71 7#b71 & 7#c71 fur!r increase ! fee rev5ue & fees if su* an adju/m5t is necess>y to provide = op]at+ res]ves ( c>ryov] us] fees = ! process = ! review ( human drug applications = ea* fiscal ye> 9 at lea/ ! foll[+ am\nts3 7i7 ,= fiscal ye> #bjbc1 at lea/ #h weeks ( op]at+ res]ves4 7ii7 ,= fiscal ye> #bjbd1 at lea/ #i weeks ( op]at+ res]ves4 7iii7 ,= fiscal ye> #bjbe & subsequ5t fiscal ye>s1 at lea/ #aj weeks ( op]at+ res]ves4 2 & 7,b7 9 subp>agraph 7,c71 by /rik+ p>agraph 7#e7 & ins]t+ p>agraph 7#f74 7#e7 ,additional direct co/ adju/m5t ,p>agraph 7#e71 z r$esignat$1 ( section #gcf7;c7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;h7c77 is am5d$ to read z foll[s3 7#e7 ,additional direct co/ adju/m5t 7,a7 ,increase ,! ,secret>y %all1 9 addition to adju/m5ts "u p>agraphs 7#a71 7#b71 7#c71 & 7#d71 fur!r increase ! fee rev5ue & fees-- 7i7 = fiscal ye> #bjbc1 by #dd1chf1aej2 & 7ii7 = ea* ( fiscal ye>s #bjbd ?r\gh #bjbg1 by ! am\nt set =? 9 clauses 7i7 ?r\gh 7iv7 ( subp>agraph 7,b71 z applicable1 multipli$ by ! ,consum] ,price ,index = urban consum]s 7,wa%+ton-,arl+ton-,alex&ria1 ,,dc-,,va-,,md-,,wv2 ,n ,seasonally ,adju/$2 ,all ,items2 ,annual ,index7 = ! mo/ rec5t ye> ( available data1 divid$ by su* ,index = #bjba4 7,b7 ,applicable am\nts ,! am\nts ref]r$ to 9 subp>agraph 7,a77ii7 are ! foll[+3 7i7 ,= fiscal ye> #bjbd1 #fj1ifg1iic4 7ii7 ,= fiscal ye> #bjbe1 #ce1gii1cad4 7iii7 ,= fiscal ye> #bjbf1 #ce1gii1 #cad4 7iv7 ,= fiscal ye> #bjbg1 #ce1gii1cad4 4 7#f7 ,annual fee sett+ ,p>agraph 7#f71 z r$esignat$1 ( section #gcf7;c7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;h7c77 is am5d$ by /rik+ ,septemb] #cj1 #bjag & ins]t+ ,septemb] #cj1 #bjbb4 7d7 ,cr$it+ & availability ( fees ,section #gcf7;g77#c7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;h7g77#c77 is am5d$ by /rik+ fiscal ye>s #bjah ?r\gh #bjbb & ins]t+ fiscal ye>s #bjbc ?r\gh #bjbg4 7e7 ,writt5 reque/s = waiv]s1 r$uctions1 exemptions1 & returns2 disputes conc]n+ fees ,section #gcf7;i7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;h7i77 is am5d$ to read z foll[s3 7i7 ,writt5 reque/s = waiv]s1 r$uctions1 exemptions1 & returns2 disputes conc]n+ fees ,to qualify = consid]ation = a waiv] or r$uction "u subsection 7d71 an exemption "u subsection 7k71 or ! return ( any fee paid "u ?is section1 includ+ if ! fee is claim$ to h be5 paid 9 error1 a p]son %all-- 7#a7 n lat] ?an #ahj days aft] su* fee is due1 submit to ! ,secret>y a writt5 reque/ ju/ify+ su* waiv]1 r$uction1 exemption1 or return2 & 7#b7 include 9 ! reque/ any legal au?orities "u :i* ! reque/ is made4 4 7f7 ,orphan drugs ,section #gcf7k7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;h7k77 is am5d$-- 7#a7 9 p>agraph 7#a77;,b71 by /rik+ dur+ ! previ\s ye> & ins]t+ z det]m9$ "u p>agraph 7#b72 & 7#b7 by am5d+ p>agraph 7#b7 to read z foll[s3 7#b7 ,evid5ce ( qualification ,an exemption "u p>agraph 7#a7 applies ) respect to a drug only if ! applicant involv$ submits a c]tification t ! applicant's gross annual rev5ues did n exce$ #ej1jjj1jjj = ! la/ cal5d> ye> end+ prior to ! fiscal ye> = :i* ! exemption is reque/$4 ,su* c]tification %all be support$ by-- 7,a7 tax returns submitt$ to ! ,unit$ ,/ates ,int]nal ,rev5ue ,s]vice2 or 7,b7 z necess>y1 o!r appropriate f9ancial in=mation4 4 #ajjd4 ,reau?orization2 report+ requirem5ts ,section #gcf;,b ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;h-#b7 is am5d$-- 7#a7 9 subsection 7a77#a71 by /rik+ ,beg9n+ ) fiscal ye> #bjah1 n & ins]t+ ,n2 7#b7 by /rik+ ,prescription ,drug ,us] ,fee ,am5dm5ts ( #bjag ea* place x appe>s & ins]t+ ,prescription ,drug ,us] ,fee ,am5dm5ts ( #bjbb2 7#c7 9 subsection 7a77#c77;,a71 by /rik+ ,n lat] ?an #cj cal5d> days aft] ! end ( ! second qu>t] ( fiscal ye> #bjah1 & n lat] ?an #cj cal5d> days aft] ! end ( ea* qu>t] ( ea* fiscal ye> !reaft] & ins]t+ ,n lat] ?an #cj cal5d> days aft] ! end ( ea* qu>t] ( ea* fiscal ye> = :i* fees are collect$ "u ?is "p2 7#d7 9 subsection 7a77#d71 by /rik+ ,beg9n+ ) fiscal ye> #bjbj1 ! & ins]t+ ,!2 7#e7 9 subsection 7b71 by /rik+ ,beg9n+ ) fiscal ye> #bjah1 n & ins]t+ ,n2 7#f7 9 subsection 7c71 by /rik+ ,beg9n+ ) fiscal ye> #bjah1 = & ins]t+ ,=2 & 7#g7 9 subsection 7f7-- 7,a7 9 p>agraph 7#a71 9 ! matt] prec$+ subp>agraph 7,a71 by /rik+ fiscal ye> #bjbb & ins]t+ fiscal ye> #bjbg2 & 7,b7 9 p>agraph 7#e71 by /rik+ ,janu>y #ae1 #bjbb & ins]t+ ,janu>y #ae1 #bjbg4 #ajje4 ,sunset dates 7a7 ,au?orization ,sections #gce & #gcf ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;g2 #cgi;h7 %all cease to be effective ,octob] #a1 #bjbg4 7b7 ,report+ ,requirem5ts ,section #gcf;,b ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;h-#b7 %all cease to be effective ,janu>y #ca1 #bjbh4 7c7 ,previ\s ,sunset ,provision ,effective ,octob] #a1 #bjbb1 subsections 7a7 & 7b7 ( section #ajd ( ! ,,fda ,reau?orization ,act ( #bjag 7,public ,law #aae-eb7 are repeal$4 #ajjf4 ,effective date ,! am5dm5ts made by ?is title %all take effect on ,octob] #a1 #bjbb1 or ! date ( ! enactm5t ( ?is ,act1 :i*ev] is lat]1 except t fees "u "p #b ( sub*apt] ,c ( *apt] ,,vii ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;g et seq47 %all be assess$ = all human drug applications receiv$ on or aft] ,octob] #a1 #bjbb1 reg>dless ( ! date ( ! enactm5t ( ?is ,act4 #ajjg4 ,sav+s clause ,not)/&+ ! am5dm5ts made by ?is title1 "p #b ( sub*apt] ,c ( *apt] ,,vii ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;g et seq471 z 9 effect on ! day be=e ! date ( ! enactm5t ( ?is title1 %all cont9ue to be 9 effect ) respect to human drug applications & supplem5ts 7z def9$ 9 su* "p z ( su* day7 t 7 accept$ by ! ,food & ,drug ,adm9i/ration = fil+ on or aft] ,octob] #a1 #bjag1 b be=e ,octob] #a1 #bjbb1 ) respect to assess+ & collect+ any fee requir$ by su* "p = a fiscal ye> prior to fiscal ye> #bjbc4 ,,ii ,fees ,relat+ to ,devices #bjja4 ,%ort title2 f9d+ 7a7 ,%ort title ,?is title may be cit$ z ! ,m$ical ,device ,us] ,fee ,am5dm5ts ( #bjbb4 7b7 ,f9d+ ,congress f9ds t ! fees au?oriz$ "u ! am5dm5ts made by ?is title w be d$icat$ t[>d exp$it+ ! process = ! review ( device applications & = assur+ ! safety & effectiv5ess ( devices1 z set =? 9 ! goals id5tifi$ = purposes ( "p #c ( sub*apt] ,c ( *apt] ,,vii ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;i et seq471 9 ! lett]s f ! ,secret>y ( ,heal? & ,human ,s]vices to ! ,*airman ( ! ,committee on ,heal?1 ,education1 ,labor1 & ,p5sions ( ! ,s5ate & ! ,*airman ( ! ,committee on ,en]gy & ,comm]ce ( ! ,h\se ( ,repres5tatives1 z set =? 9 ! ,congressional ,record4 #bjjb4 ,def9itions ,section #gcg ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;i7 is am5d$-- 7#a7 9 p>agraph 7#i7-- 7,a7 9 ! matt] prec$+ subp>agraph 7,a71 by /rik+ & prem>ket notification submissions & ins]t+ prem>ket notification submissions1 & de novo classification reque/s2 7,b7 9 subp>agraph 7,d71 by /rik+ & submissions & ins]t+ submissions1 & de novo classification reque/s2 7,c7 9 subp>agraph 7,f71 by /rik+ & prem>ket notification submissions & ins]t+ prem>ket notification submissions1 & de novo classification reque/s2 7,d7 9 ea* ( subp>agraphs 7,g7 & 7,h71 by /rik+ or submissions & ins]t+ submissions1 or reque/s2 & 7,e7 9 subp>agraph 7,k71 by /rik+ or prem>ket notification submissions & ins]t+ prem>ket notification submissions1 or de novo classification reque/s2 & 7#b7 9 p>agraph 7#aa71 by /rik+ #bjaf & ins]t+ #bjba4 #bjjc4 ,au?ority to assess & use device fees 7a7 ,types ( ,fees ,section #gch7;a7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;j7a77 is am5d$-- 7#a7 9 p>agraph 7#a71 by /rik+ fiscal ye> #bjah & ins]t+ fiscal ye> #bjbc2 & 7#b7 9 p>agraph 7#b7-- 7,a7 9 subp>agraph 7,a7-- 7i7 9 ! matt] prec$+ clause 7i71 by /rik+ ,octob] #a1 #bjag & ins]t+ ,octob] #a1 #bjbb2 7ii7 9 clause 7iii71 by /rik+ #ge p]c5t & ins]t+ #hj p]c5t2 & 7iii7 9 clause 7viii71 by /rik+ #c4d p]c5t & ins]t+ #d4e p]c5t2 7,b7 9 subp>agraph 7,b77iii71 by /rik+ or prem>ket notification submission & ins]t+ prem>ket notification submission1 or de novo classification reque/2 & 7,c7 9 subp>agraph 7,c71 by /rik+ or p]iodic report+ conc]n+ a class ,,iii device & ins]t+ p]iodic report+ conc]n+ a class ,,iii device1 or de novo classification reque/4 7b7 ,fee ,am\nts ,section #gch7;b7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;j7b77 is am5d$-- 7#a7 9 p>agraph 7#a71 by /rik+ #bjah ?r\gh #bjbb & ins]t+ #bjbc ?r\gh #bjbg2 7#b7 by am5d+ p>agraph 7#b7 to read z foll[s3 7#b7 ,base fee am\nts specifi$ ,= purposes ( p>agraph 7#a71 ! base fee am\nts specifi$ 9 ?is p>agraph are z foll[s3 ,fee ,type,fiscal ,ye> #bjbc;,fiscal ,ye> #bjbd;,fiscal ,ye> #bjbe;,fiscal ,ye> #bjbf;,fiscal ,ye> #bjbg,prem>ket ,application#dbe1jjjdce1jjjdde1jjjdee1jj jdgj1jjj;,e/abli%m5t ,regi/ration#f1bejf1hgeg1ajjg1egeh1dfe 2 & 7#c7 by am5d+ p>agraph 7#c7 to read z foll[s3 7#c7 ,total rev5ue am\nts specifi$ ,= purposes ( p>agraph 7#a71 ! total rev5ue am\nts specifi$ 9 ?is p>agraph are z foll[s3 7,a7 #cab1fjf1jjj = fiscal ye> #bjbc4 7,b7 #cce1gej1jjj = fiscal ye> #bjbd4 7,c7 #cej1gdf1djj = fiscal ye> #bjbe4 7,d7 #cff1dhf1cjj = fiscal ye> #bjbf4 7,e7 #dah1cdc1jjj = fiscal ye> #bjbg4 4 7c7 ,annual ,fee ,sett+2 ,adju/m5ts ,section #gch7;c7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;j7c77 is am5d$-- 7#a7 9 p>agraph 7#a71 by /rik+ #bjag & ins]t+ #bjbb2 7#b7 9 p>agraph 7#b7-- 7,a7 9 subp>agraph 7,a71 by /rik+ #bjah & ins]t+ #bjbc2 7,b7 9 subp>agraph 7,b7-- 7i7 9 ! matt] prec$+ clause 7i71 by /rik+ fiscal ye> #bjah & ins]t+ fiscal ye> #bjbc2 & 7ii7 9 clause 7ii71 by /rik+ fiscal ye> #bjaf & ins]t+ fiscal ye> #bjbb2 7,c7 9 subp>agraph 7,c71 by /rik+ ,wa%+ton-,baltimore1 ,,dc-,,md-,,va-,,wv & ins]t+ ,wa%+ton-,arl+ton-,alex&ria1 ,,dc-,,va-,,md-,,wv2 & 7,d7 9 subp>agraph 7,d71 9 ! matt] prec$+ clause 7i71 by /rik+ fiscal ye>s #bjah ?r\gh #bjbb & ins]t+ fiscal ye>s #bjbc ?r\gh #bjbg2 7#c7 9 p>agraph 7#c71 by /rik+ #bjah ?r\gh #bjbb & ins]t+ #bjbc ?r\gh #bjbg2 7#d7 by r$esignat+ p>agraphs 7#d7 & 7#e7 z p>agraphs 7#g7 & 7#h71 respectively2 & 7#e7 by ins]t+ aft] p>agraph 7#c7 ! foll[+3 7#d7 ,p]=mance improvem5t adju/m5t 7,a7 ,9 g5]al ,= ea* ( fiscal ye>s #bjbe ?r\gh #bjbg1 aft] ! adju/m5ts "u p>agraphs 7#b7 & 7#c71 ! base e/abli%m5t regi/ration fee am\nts = su* fiscal ye> %all be increas$ to reflect *anges 9 ! res\rce ne$s ( ! ,secret>y due to improv$ review p]=mance goals = ! process = ! review ( device applications id5tifi$ 9 ! lett]s describ$ 9 section #bjja7;b7 ( ! ,m$ical ,device ,us] ,fee ,am5dm5ts ( #bjbb1 z ! ,secret>y det]m9es necess>y to a*ieve an increase 9 total fee collections = su* fiscal ye> equal to ! foll[+ am\nts1 z applicable3 7i7 ,= fiscal ye> #bjbe1 ! product (-- 7,i7 ! am\nt det]m9$ "u subp>agraph 7,b77i77,i72 & 7,,ii7 ! applicable inflation adju/m5t "u p>agraph 7#b77;,b7 = su* fiscal ye>4 7ii7 ,= fiscal ye> #bjbf1 ! product (-- 7,i7 ! sum ( ! am\nts det]m9$ "u subp>agraphs 7,b77i77,,ii71 7,b77ii77,i71 & 7,b77iii77,i72 & 7,,ii7 ! applicable inflation adju/m5t "u p>agraph 7#b77;,b7 = su* fiscal ye>4 7iii7 ,= fiscal ye> #bjbg1 ! product (-- 7,i7 ! sum ( ! am\nts det]m9$ "u subp>agraphs 7,b77i77,,iii71 7,b77ii77,,ii71 & 7,b77iii77,,ii72 & 7,,ii7 ! applicable inflation adju/m5t "u p>agraph 7#b77;,b7 = su* fiscal ye>4 7,b7 ,am\nts 7i7 ,presubmission am\nt ,= purposes ( subp>agraph 7,a71 ) respect to ! ,presubmission ,writt5 ,fe$back goal1 ! am\nts det]m9$ "u ?is subp>agraph are z foll[s3 7,i7 ,= fiscal ye> #bjbe1 #ae1cif1fjj if su* goal = fiscal ye> #bjbc is met4 7,,ii7 ,= fiscal ye> #bjbf3 7aa7 #ae1cif1fjj if su* goal = fiscal ye> #bjbc is met & su* goal = fiscal ye> #bjbd is n met4 7bb7 #cf1gib1bjj if su* goal = fiscal ye> #bjbd is met4 7,,iii7 ,= fiscal ye> #bjbg3 7aa7 #ae1cif1fjj if su* goal = fiscal ye> #bjbc is met & su* goal = ea* ( fiscal ye>s #bjbd & #bjbe is n met4 7bb7 #cf1gib1bjj if su* goal = fiscal ye> #bjbd is met & su* goal = fiscal ye> #bjbe is n met4 7cc7 #dj1egb1fjj if su* goal = fiscal ye> #bjbe is met4 7ii7 ,de novo classification reque/ am\nt ,= purposes ( subp>agraph 7,a71 ) respect to ! ,de ,novo ,decision goal1 ! am\nts det]m9$ "u ?is subp>agraph are z foll[s3 7,i7 ,= fiscal ye> #bjbf1 #f1cbc1ejj if su* goal = fiscal ye> #bjbc is met4 7,,ii7 ,= fiscal ye> #bjbg3 7aa7 #f1cbc1ejj if su* goal = fiscal ye> #bjbc is met & su* goal = fiscal ye> #bjbd is n met4 7bb7 #aa1gfe1djj if su* goal = fiscal ye> #bjbd is met4 7iii7 ,prem>ket notification & prem>ket approval am\nt ,= purposes ( subp>agraph 7,a71 ) respect to ! #eaj7k7 decision goal1 #eaj7k7 ,%>$ ,outcome ,total ,"t to ,decision goal1 ,,pma decision goal1 & ,,pma ,%>$ ,outcome ,total ,"t to ,decision goal1 ! am\nts det]m9$ "u ?is subp>agraph are z foll[s3 7,i7 ,= fiscal ye> #bjbf1 #a1jbj1jjj if ! #d goals = fiscal ye> #bjbc are met4 7,,ii7 ,= fiscal ye> #bjbg3 7aa7 #a1jbj1jjj if ! #d goals = fiscal ye> #bjbc are met & "o or m ( ! #d goals = fiscal ye> #bjbd are n met4 7bb7 #c1ijf1jjj if ! #d goals = fiscal ye> #bjbd are met4 7,c7 ,p]=mance calculation ,= purposes ( ?is p>agraph1 p]=mance ( ! foll[+ goals %all be det]m9$ z specifi$ 9 ! lett]s describ$ 9 section #bjja7;b7 ( ! ,m$ical ,device ,us] ,fee ,am5dm5ts ( #bjbb & bas$ on data available1 z foll[s3 7i7 ,! p]=mance ( ! ,presubmission ,writt5 ,fe$back goal %all be bas$ on data available z (-- 7,i7 = fiscal ye> #bjbc1 ,m>* #ca1 #bjbd2 7,,ii7 = fiscal ye> #bjbd1 ,m>* #ca1 #bjbe2 & 7,,iii7 = fiscal ye> #bjbe1 ,m>* #ca1 #bjbf4 7ii7 ,! p]=mance ( ! ,de ,novo ,decision goal1 #eaj7k7 decision goal1 #eaj7k7 ,%>$ ,outcome ,total ,"t to ,decision goal1 ,,pma decision goal1 & ,,pma ,%>$ ,outcome ,total ,"t to ,decision goal %all be bas$ on data available z (-- 7,i7 = fiscal ye> #bjbc1 ,m>* #ca1 #bjbe2 & 7,,ii7 = fiscal ye> #bjbd1 ,m>* #ca1 #bjbf4 7,d7 ,goals def9$ ,= purposes ( ?is p>agraph1 ! t]ms ,presubmission ,writt5 ,fe$back goal1 ,de ,novo ,decision goal1 #eaj7k7 decision goal1 #eaj7k7 ,%>$ ,outcome ,total ,"t to ,decision goal1 ,,pma decision goal1 & ,,pma ,%>$ ,outcome ,total ,"t to ,decision goal ref] to ! goals id5tifi$ by ! same names 9 ! lett]s describ$ 9 section #bjja7;b7 ( ! ,m$ical ,device ,us] ,fee ,am5dm5ts ( #bjbb4 7#e7 ,hir+ adju/m5t 7,a7 ,9 g5]al ,= ea* ( fiscal ye>s #bjbe ?r\gh #bjbg1 aft] ! adju/m5ts "u p>agraphs 7#b71 7#c71 & 7#d71 if applicable1 if ! numb] ( hires to support ! process = ! review ( device applications falls bel[ ! ?re%olds specifi$ 9 subp>agraph 7,b7 = ! applicable fiscal ye>s1 ! base e/abli%m5t regi/ration fee am\nts %all be decreas$ z ! ,secret>y det]m9es necess>y to a*ieve a r$uction 9 total fee collections equal to ! hir+ adju/m5t am\nt "u subp>agraph 7,c74 7,b7 ,?re%olds ,! ?re%olds specifi$ 9 ?is subp>agraph are z foll[s3 7i7 ,= fiscal ye> #bjbe1 ! ?re%old is #abc hires = fiscal ye> #bjbc4 7ii7 ,= fiscal ye> #bjbf1 ! ?re%old is #ch hires = fiscal ye> #bjbd4 7iii7 ,= fiscal ye> #bjbg1 ! ?re%old is-- 7,i7 #bb hires = fiscal ye> #bjbe if ! base e/abli%m5t regi/ration fees are n increas$ by ! am\nt det]m9$ "u p>agraph 7#d77;,a77i72 or 7,,ii7 #ge hires = fiscal ye> #bjbe if su* fees are s increas$4 7,c7 ,hir+ adju/m5t am\nt ,! hir+ adju/m5t am\nt = fiscal ye> #bjbe & ea* subsequ5t fiscal ye> is ! product (-- 7i7 ! numb] ( hires by :i* ! hir+ goal specifi$ 9 subp>agraph 7,d7 = ! fiscal ye> be=e ! prior fiscal ye> 0 n met2 7ii7 #gb1hgg2 & 7iii7 ! applicable inflation adju/m5t "u p>agraph 7#b77;,b7 = ! fiscal ye> = :i* ! hir+ goal 0 n met4 7,d7 ,hir+ goals ,! hir+ goals = ea* ( fiscal ye>s #bjbc ?r\gh #bjbe are z foll[s3 7i7 ,= fiscal ye> #bjbc1 #add hires4 7ii7 ,= fiscal ye> #bjbd1 #db hires4 7iii7 ,= fiscal ye> #bjbe3 7,i7 #bd hires if ! base e/abli%m5t regi/ration fees are n increas$ by ! am\nt det]m9$ "u p>agraph 7#d77;,a77i74 7,,ii7 #hc hires if ! base e/abli%m5t regi/ration fees are increas$ by ! am\nt det]m9$ "u p>agraph 7#d77;,a77i74 7,e7 ,numb] ( hires ,= purposes ( ?is p>agraph1 ! numb] ( hires = a fiscal ye> %all be det]m9$ by ! ,secret>y z set =? 9 ! lett]s describ$ 9 section #bjja7;b7 ( ! ,m$ical ,device ,us] ,fee ,am5dm5ts ( #bjbb4 7#f7 ,op]at+ res]ve adju/m5t 7,a7 ,9 g5]al ,= ea* ( fiscal ye>s #bjbc ?r\gh #bjbg1 aft] ! adju/m5ts "u p>agraphs 7#b71 7#c71 7#d71 & 7#e71 if applicable1 if ! ,secret>y has op]at+ res]ves ( c>ryov] us] fees = ! process = ! review ( device applications 9 excess ( ! designat$ am\nt 9 subp>agraph 7,b71 ! ,secret>y %all decrease ! base e/abli%m5t regi/ration fee am\nts to provide = n m ?an su* designat$ am\nt ( op]at+ res]ves4 7,b7 ,designat$ am\nt ,subject to subp>agraph 7,c71 = ea* fiscal ye>1 ! designat$ am\nt 9 ?is subp>agraph is equal to ! sum (-- 7i7 #ac weeks ( op]at+ res]ves ( c>ryov] us] fees2 & 7ii7 #a mon? ( op]at+ res]ves ma9ta9$ pursuant to p>agraph 7#h74 7,c7 ,exclud$ am\nt ,= ! p]iod ( fiscal ye>s #bjbc ?r\gh #bjbf1 a total am\nt equal to #aah1jjj1jjj %all n be consid]$ "p ( ! designat$ am\nt "u subp>agraph 7,b7 & %all n be subject to ! decrease "u subp>agraph 7,a74 4 7d7 ,conditions ,section #gch7;g7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;j7g77 is am5d$-- 7#a7 9 p>agraph 7#a77;,a71 by /rik+ #cbj1hbe1jjj & ins]t+ #cih1eff1jjj2 & 7#b7 9 p>agraph 7#b71 by ins]t+ de novo classification reque/s1 aft] class ,,iii device14 7e7 ,cr$it+ & ,availability ( ,fees ,section #gch7;h77#c7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;j7h77#c77 is am5d$ to read z foll[s3 7#c7 ,au?orization ( appropriations 7,a7 ,9 g5]al ,= ea* ( fiscal ye>s #bjbc ?r\gh #bjbg1 !re is au?oriz$ to be appropriat$ = fees "u ?is section an am\nt equal to ! rev5ue am\nt det]m9$ "u subp>agraph 7,b71 less ! am\nt ( r$uctions det]m9$ "u subp>agraph 7,c74 7,b7 ,rev5ue am\nt ,= purposes ( ?is p>agraph1 ! rev5ue am\nt = ea* fiscal ye> is ! sum (-- 7i7 ! total rev5ue am\nt "u subsection 7b77#c7 = ! fiscal ye>1 z adju/$ "u p>agraphs 7#b7 & 7#c7 ( subsection 7c72 & 7ii7 ! p]=mance improvem5t adju/m5t am\nt = ! fiscal ye> "u subsection 7c77#d71 if applicable4 7,c7 ,am\nt ( r$uctions ,= purposes ( ?is p>agraph1 ! am\nt ( r$uctions = ea* fiscal ye> is ! sum (-- 7i7 ! hir+ adju/m5t am\nt = ! fiscal ye> "u subsection 7c77#e71 if applicable2 & 7ii7 ! op]at+ res]ve adju/m5t am\nt = ! fiscal ye> "u subsection 7c77#f71 if applicable4 4 #bjjd4 ,reau?orization2 report+ requirem5ts 7a7 ,p]=mance reports ,section #gch;,a7a7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;j-#a7;a77 is am5d$-- 7#a7 by /rik+ fiscal ye> #bjah ea* place x appe>s & ins]t+ fiscal ye> #bjbc2 7#b7 by /rik+ ,m$ical ,device ,us] ,fee ,am5dm5ts ( #bjag ea* place x appe>s & ins]t+ ,m$ical ,device ,us] ,fee ,am5dm5ts ( #bjbb2 7#c7 9 p>agraph 7#a7-- 7,a7 9 subp>agraph 7,a71 by r$esignat+ ! second clause 7iv7 7relat+ to analysis7 z clause 7v72 & 7,b7 9 subp>agraph 7,a77iv71 by /rik+ fiscal ye> #bjbj & ins]t+ fiscal ye> #bjbc2 & 7#d7 9 p>agraph 7#d71 by /rik+ #bjah ?r\gh #bjbb & ins]t+ #bjbc ?r\gh #bjbg4 7b7 ,reau?orization ,section #gch;,a7b7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;j-#a7;b77 is am5d$-- 7#a7 9 p>agraph 7#a71 by /rik+ #bjbb & ins]t+ #bjbg2 & 7#b7 9 p>agraph 7#e71 by /rik+ #bjbb & ins]t+ #bjbg4 #bjje4 ,con=mity assessm5t pilot program ,section #ead7;d7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;d7d77 is am5d$ to read z foll[s3 7d7 ,accr$itation s*eme = con=mity assessm5t 7#a7 ,9 g5]al ,! ,secret>y %all e/abli% a program "u :i*-- 7,a7 te/+ laboratories meet+ crit]ia specifi$ 9 guidance by ! ,secret>y may be accr$it$1 by accr$itation bodies meet+ crit]ia specifi$ 9 guidance by ! ,secret>y1 to conduct te/+ to support ! assessm5t ( ! con=mity ( a device to c]ta9 /&>ds recogniz$ "u ?is section2 & 7,b7 subject to p>agraph 7#b71 results f te/s conduct$ to support ! assessm5t ( con=mity ( devices z describ$ 9 subp>agraph 7,a7 conduct$ by te/+ laboratories accr$it$ pursuant to ?is subsection %all be accept$ by ! ,secret>y = purposes ( demon/rat+ su* con=mity unless ! ,secret>y f9ds t c]ta9 results ( su* te/s %\ld n be s accept$4 7#b7 ,secret>ial review ( accr$it$ laboratory results ,! ,secret>y may-- 7,a7 review ! results ( te/s conduct$ by te/+ laboratories accr$it$ pursuant to ?is subsection1 includ+ by conduct+ p]iodic audits ( su* results or ( ! processes ( accr$it$ bodies or te/+ laboratories2 7,b7 foll[+ su* review1 take additional measures "u ?is ,act1 z ! ,secret>y det]m9es appropriate1 su* z-- 7i7 susp5sion or )drawal ( accr$itation ( a te/+ laboratory or recognition ( an accr$itation body "u p>agraph 7#a77;,a72 or 7ii7 reque/+ additional in=mation ) respect to a device2 & 7,c7 if ! ,secret>y becomes aw>e ( in=mation mat]ially be>+ on ! safety or effectiv5ess ( a device = :i* an assessm5t ( con=mity 0 support$ by te/+ conduct$ by a te/+ laboratory accr$it$ "u ?is subsection1 take su* additional measures "u ?is ,act1 z ! ,secret>y det]m9es appropriate1 su* z-- 7i7 susp5sion or )drawal ( accr$itation ( a te/+ laboratory or recognition ( an accr$itation body "u p>agraph 7#a77;,a72 or 7ii7 reque/+ additional in=mation ) reg>d to su* device4 7#c7 ,report ,! ,secret>y %all make available on ! int]net website ( ! ,food & ,drug ,adm9i/ration an annual report on ! progress ( ! program "u ?is subsection4 4 #bjjf4 ,reau?orization ( ?ird-p>ty review program ,section #ebc7;c7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cfjm7c77 is am5d$ by /rik+ ,octob] #a & ins]t+ ,decemb] #ag4 #bjjg4 ,sunset dates 7a7 ,au?orization ,sections #gcg & #gch ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;i2 #cgi;j7 %all cease to be effective ,octob] #a1 #bjbg4 7b7 ,report+ requirem5ts ,section #gch;,a ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;j-#a7 %all cease to be effective ,janu>y #ca1 #bjbh4 7c7 ,previ\s sunset provisions ,effective ,octob] #a1 #bjbb1 subsections 7a7 & 7b7 ( section #baj ( ! ,,fda ,reau?orization ,act ( #bjag 7,public ,law #aae-eb7 are repeal$4 #bjjh4 ,effective date ,! am5dm5ts made by ?is title %all take effect on ,octob] #a1 #bjbb1 or ! date ( ! enactm5t ( ?is ,act1 :i*ev] is lat]1 except t fees "u "p #c ( sub*apt] ,c ( *apt] ,,vii ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;i et seq47 %all be assess$ = all submissions li/$ 9 section #gch7;a77#b77;,a7 ( su* ,act receiv$ on or aft] ,octob] #a1 #bjbb1 reg>dless ( ! date ( ! enactm5t ( ?is ,act4 #bjji4 ,sav+s clause ,not)/&+ ! am5dm5ts made by ?is title1 "p #c ( sub*apt] ,c ( *apt] ,,vii ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;i et seq471 z 9 effect on ! day be=e ! date ( ! enactm5t ( ?is title1 %all cont9ue to be 9 effect ) respect to ! submissions li/$ 9 section #gch7;a77#b77;,a7 ( su* ,act 7z def9$ 9 su* "p z ( su* day7 t on or aft] ,octob] #a1 #bjag1 b be=e ,octob] #a1 #bjbb1 7 receiv$ by ! ,food & ,drug ,adm9i/ration ) respect to assess+ & collect+ any fee requir$ by su* "p = a fiscal ye> prior to fiscal ye> #bjbc4 ,,iii ,fees ,relat+ to ,g5]ic ,drugs #cjja4 ,%ort title2 f9d+ 7a7 ,%ort title ,?is title may be cit$ z ! ,g5]ic ,drug ,us] ,fee ,am5dm5ts ( #bjbb4 7b7 ,f9d+ ,congress f9ds t ! fees au?oriz$ by ! am5dm5ts made by ?is title w be d$icat$ to human g5]ic drug activities1 z set =? 9 ! goals id5tifi$ = purposes ( "p #g ( sub*apt] ,c ( *apt] ,,vii ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;j-#da et seq471 9 ! lett]s f ! ,secret>y ( ,heal? & ,human ,s]vices to ! ,*airman ( ! ,committee on ,heal?1 ,education1 ,labor1 & ,p5sions ( ! ,s5ate & ! ,*airman ( ! ,committee on ,en]gy & ,comm]ce ( ! ,h\se ( ,repres5tatives1 z set =? 9 ! ,congressional ,record4 #cjjb4 ,au?ority to assess & use human g5]ic drug fees 7a7 ,types ( fees ,section #gdd;,b7a7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;j-#db7;a77 is am5d$-- 7#a7 9 ! matt] prec$+ p>agraph 7#a71 by /rik+ #bjah & ins]t+ #bjbc2 7#b7 9 p>agraph 7#b77;,c71 by /rik+ #bjah ?r\gh #bjbb & ins]t+ #bjbc ?r\gh #bjbg2 7#c7 9 p>agraph 7#c77;,b71 by /rik+ #bjah ?r\gh #bjbb & ins]t+ #bjbc ?r\gh #bjbg2 7#d7 9 p>agraph 7#d77;,d71 by /rik+ #bjah ?r\gh #bjbb & ins]t+ #bjbc ?r\gh #bjbg2 & 7#e7 9 p>agraph 7#e77;,d71 by /rik+ #bjah ?r\gh #bjbb & ins]t+ #bjbc ?r\gh #bjbg4 7b7 ,fee rev5ue am\nts ,section #gdd;,b7b7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;j-#db7;b77 is am5d$-- 7#a7 9 p>agraph 7#a7-- 7,a7 9 subp>agraph 7,a7-- 7i7 9 ! head+1 by /rik+ #bjah & ins]t+ #bjbc2 7ii7 by /rik+ #bjah & ins]t+ #bjbc2 & 7iii7 by /rik+ #dic1fjj1jjj & ins]t+ #ehb1ejj1jjj2 & 7,b7 by am5d+ subp>agraph 7,b7 to read z foll[s3 7,b7 ,fiscal ye>s #bjbd ?r\gh #bjbg 7i7 ,9 g5]al ,= ea* ( ! fiscal ye>s #bjbd ?r\gh #bjbg1 fees "u p>agraphs 7#b7 ?r\gh 7#e7 ( subsection 7a7 %all be e/abli%$ to g5]ate a total e/imat$ rev5ue am\nt "u su* subsection t is equal to ! base rev5ue am\nt = ! fiscal ye> "u clause 7ii71 z adju/$ pursuant to subsection 7c74 7ii7 ,base rev5ue am\nt ,! base rev5ue am\nt = a fiscal ye> ref]r$ to 9 clause 7i7 is equal to ! total rev5ue am\nt e/abli%$ "u ?is p>agraph = ! previ\s fiscal ye>1 n includ+ any adju/m5ts made = su* previ\s fiscal ye> "u subsection 7c77#c74 2 & 7#b7 9 p>agraph 7#b7-- 7,a7 9 subp>agraph 7,c71 by /rik+ "o-?ird ! am\nt & ins]t+ tw5ty-f\r p]c5t2 7,b7 9 subp>agraph 7,d71 by /rik+ ,sev5 p]c5t & ins]t+ ,six p]c5t2 & 7,c7 9 subp>agraph 7,e77i71 by /rik+ ,?irty-five p]c5t & ins]t+ ,?irty-six p]c5t4 7c7 ,adju/m5ts ,section #gdd;,b7c7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;j-#db7;c77 is am5d$-- 7#a7 9 p>agraph 7#a7-- 7,a7 9 ! matt] prec$+ subp>agraph 7,a7-- 7i7 by /rik+ #bjai & ins]t+ #bjbd2 & 7ii7 by /rik+ to equal ! product ( ! total rev5ues e/abli%$ 9 su* notice = ! prior fiscal ye> multipli$ & ins]t+ to equal ! base rev5ue am\nt = ! fiscal ye> 7z specifi$ 9 subsection 7b77#a77;,b77ii77 multipli$2 & 7,b7 9 subp>agraph 7,c71 by /rik+ ,wa%+ton-,baltimore1 ,,dc-,,md-,,va-,,wv & ins]t+ ,wa%+ton-,arl+ton-,alex&ria1 ,,dc-,,va-,,md-,,wv2 & 7#b7 by /rik+ p>agraph 7#b7 & ins]t+ ! foll[+3 7#b7 ,capacity plann+ adju/m5t 7,a7 ,9 g5]al ,beg9n+ ) fiscal ye> #bjbd1 ! ,secret>y %all1 9 addition to ! adju/m5t "u p>agraph 7#a71 fur!r increase ! fee rev5ue & fees "u ?is section = a fiscal ye>1 9 accordance ) ?is p>agraph1 to reflect *anges 9 ! res\rce capacity ne$s ( ! ,secret>y = human g5]ic drug activities4 7,b7 ,capacity plann+ me?odology ,! ,secret>y %all e/abli% a capacity plann+ me?odology = purposes ( ?is p>agraph1 :i* %all-- 7i7 be d]iv$ f ! me?odology & recomm5dations made 9 ! report titl$ ,indep5d5t ,evaluation ( ! ,,gdufa ,res\rce ,capacity ,plann+ ,adju/m5t ,me?odology3 ,evaluation & ,recomm5dations ann\nc$ 9 ! ,f$]al ,regi/] on ,augu/ #c1 #bjbj 7#he ,f$4 ,reg4 #dffeh72 & 7ii7 incorporate approa*es & attributes det]m9$ appropriate by ! ,secret>y1 includ+ approa*es & attributes made 9 su* report1 except t 9 incorporat+ su* approa*es & attributes ! workload categories us$ 9 =eca/+ res\rces %all only be ! workload categories specifi$ 9 section ,,viii4,b4#b4;e4 ( ! lett]s describ$ 9 section #cjja7;b7 ( ! ,g5]ic ,drug ,us] ,fee ,am5dm5ts ( #bjbb4 7,c7 ,limitations 7i7 ,9 g5]al ,"u no circum/ances %all an adju/m5t "u ?is p>agraph result 9 fee rev5ue = a fiscal ye> t is less ?an ! sum ( ! am\nts "u subsection 7b77#a77;,b77ii7 7! base rev5ue am\nt = ! fiscal ye>7 & p>agraph 7#a7 7! doll> am\nt ( ! inflation adju/m5t = ! fiscal ye>74 7ii7 ,additional limitation ,an adju/m5t "u ?is p>agraph %all n exce$ #c p]c5t ( ! sum describ$ 9 clause 7i7 = ! fiscal ye>1 except t su* limitation %all be #d p]c5t if-- 7,i7 = purposes ( a fiscal ye> #bjbd adju/m5t1 ! ,secret>y det]m9es t dur+ ! p]iod f ,april #a1 #bjba1 ?r\gh ,m>* #ca1 #bjbc-- 7aa7 ! total numb] ( abbreviat$ new drug applications submitt$ 0 great] ?an or equal to #b1jjj2 or 7bb7 ?irty-five p]c5t or m ( abbreviat$ new drug applications submitt$ relat$ to complex products 7z t t]m is def9$ 9 section ,,xi ( ! lett]s describ$ 9 section #cjja7;b7 ( ! ,g5]ic ,drug ,us] ,fee ,am5dm5ts ( #bjbb72 7,,ii7 = purposes ( a fiscal ye> #bjbe adju/m5t1 ! ,secret>y det]m9es t dur+ ! p]iod f ,april #a1 #bjbb1 ?r\gh ,m>* #ca1 #bjbd-- 7aa7 ! total numb] ( abbreviat$ new drug applications submitt$ 0 great] ?an or equal to #b1cjj2 or 7bb7 ?irty-five p]c5t or m ( abbreviat$ new drug applications submitt$ relat$ to complex products 7z s def9$72 7,,iii7 = purposes ( a fiscal ye> #bjbf adju/m5t1 ! ,secret>y det]m9es t dur+ ! p]iod f ,april #a1 #bjbc1 ?r\gh ,m>* #ca1 #bjbe-- 7aa7 ! total numb] ( abbreviat$ new drug applications submitt$ 0 great] ?an or equal to #b1cjj2 or 7bb7 ?irty-five p]c5t or m ( abbreviat$ new drug applications submitt$ relat$ to complex products 7z s def9$72 & 7,,iv7 = purposes ( a fiscal ye> #bjbg adju/m5t1 ! ,secret>y det]m9es t dur+ ! p]iod f ,april #a1 #bjbd1 ?r\gh ,m>* #ca1 #bjbf-- 7aa7 ! total numb] ( abbreviat$ new drug applications submitt$ 0 great] ?an or equal to #b1cjj2 or 7bb7 ?irty-five p]c5t or m ( abbreviat$ new drug applications submitt$ relat$ to complex products 7z s def9$74 7,d7 ,publication 9 ,f$]al ,regi/] ,! ,secret>y %all publi% 9 ! ,f$]al ,regi/] notice ref]r$ to 9 subsection 7a7 ! fee rev5ue & fees result+ f ! adju/m5t & ! me?odology "u ?is p>agraph4 7#c7 ,op]at+ res]ve adju/m5t 7,a7 ,9 g5]al ,= fiscal ye> #bjbd & ea* subsequ5t fiscal ye>1 ! ,secret>y may1 9 addition to adju/m5ts "u p>agraphs 7#a7 & 7#b71 fur!r increase ! fee rev5ue & fees "u ?is section = su* fiscal ye> if su* an adju/m5t is necess>y to provide op]at+ res]ves ( c>ryov] us] fees = human g5]ic drug activities = n m ?an ! numb] ( weeks specifi$ 9 subp>agraph 7,b7 ) respect to t fiscal ye>4 7,b7 ,numb] ( weeks ,! numb] ( weeks specifi$ 9 ?is subp>agraph is-- 7i7 #h weeks = fiscal ye> #bjbd2 7ii7 #i weeks = fiscal ye> #bjbe2 & 7iii7 #aj weeks = ea* ( fiscal ye> #bjbf & #bjbg4 7,c7 ,decrease ,if ! ,secret>y has c>ryov] balances = human g5]ic drug activities 9 excess ( #ab weeks ( ! op]at+ res]ves ref]r$ to 9 subp>agraph 7,a71 ! ,secret>y %all decrease ! fee rev5ue & fees ref]r$ to 9 su* subp>agraph to provide = n m ?an #ab weeks ( su* op]at+ res]ves4 7,d7 ,rationale = adju/m5t ,if an adju/m5t "u ?is p>agraph is made1 ! rationale = ! am\nt ( ! increase or decrease 7z applicable7 9 fee rev5ue & fees %all be conta9$ 9 ! annual ,f$]al ,regi/] notice "u subsection 7a7 publi%+ ! fee rev5ue & fees = ! fiscal ye> involv$4 4 7d7 ,annual fee sett+ ,section #gdd;,b7d77#a7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;j-#db7;d77#a77 is am5d$-- 7#a7 9 ! p>agraph head+1 by /rik+ #bjah ?r\gh #bjbb & ins]t+ #bjbc ?r\gh #bjbg2 & 7#b7 by /rik+ m ?an #fj days be=e ! fir/ day ( ea* ( fiscal ye>s #bjah ?r\gh #bjbb & ins]t+ lat] ?an #fj days be=e ! fir/ day ( ea* ( fiscal ye>s #bjbc ?r\gh #bjbg4 7e7 ,effect ( failure to pay fees ,! head+ ( p>agraph 7#c7 ( section #gdd;,b7g7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;j-#db7;g77 is am5d$ by /rik+ & prior approval supplem5t fee4 7f7 ,cr$it+ & availability ( fees ,section #gdd;,b7i77#c7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;j-#db7;i77#c77 is am5d$ by /rik+ fiscal ye>s #bjah ?r\gh #bjbb & ins]t+ fiscal ye>s #bjbc ?r\gh #bjbg4 #cjjc4 ,reau?orization2 report+ requirem5ts ,section #gdd;,c ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;j-#dc7 is am5d$-- 7#a7 9 subsection 7a77#a71 by /rik+ ,beg9n+ ) fiscal ye> #bjah1 n & ins]t+ ,n2 7#b7 by /rik+ ,g5]ic ,drug ,us] ,fee ,am5dm5ts ( #bjag ea* place x appe>s & ins]t+ ,g5]ic ,drug ,us] ,fee ,am5dm5ts ( #bjbb2 7#c7 9 subsection 7a77#b71 by /rik+ ,n lat] ?an #cj cal5d> days aft] ! end ( ! second qu>t] ( fiscal ye> #bjah1 & n lat] ?an #cj cal5d> days aft] ! end ( ea* qu>t] ( ea* fiscal ye> !reaft] & ins]t+ ,n lat] ?an #cj cal5d> days aft] ! end ( ea* qu>t] ( ea* fiscal ye> = :i* fees are collect$ "u ?is "p2 7#d7 9 subsection 7a77#c71 by /rik+ ,beg9n+ ) fiscal ye> #bjbj1 ! & ins]t+ ,!2 7#e7 9 subsection 7b71 by /rik+ ,beg9n+ ) fiscal ye> #bjah1 n & ins]t+ ,n2 7#f7 9 subsection 7c71 by /rik+ ,beg9n+ ) fiscal ye> #bjah1 = & ins]t+ ,=2 & 7#g7 9 subsection 7f7-- 7,a7 9 p>agraph 7#a71 9 ! matt] prec$+ subp>agraph 7,a71 by /rik+ fiscal ye> #bjbb & ins]t+ fiscal ye> #bjbg2 & 7,b7 9 p>agraph 7#e71 by /rik+ ,janu>y #ae1 #bjbb & ins]t+ ,janu>y #ae1 #bjbg4 #cjjd4 ,sunset dates 7a7 ,au?orization ,sections #gdd;,a & #gdd;,b ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;j-#da2 #cgi;j-#db7 %all cease to be effective ,octob] #a1 #bjbg4 7b7 ,report+ requirem5ts ,section #gdd;,c ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;j-#dc7 %all cease to be effective ,janu>y #ca1 #bjbh4 7c7 ,previ\s sunset provision ,effective ,octob] #a1 #bjbb1 subsections 7a7 & 7b7 ( section #cje ( ! ,,fda ,reau?orization ,act ( #bjag 7,public ,law #aae-eb7 are repeal$4 #cjje4 ,effective date ,! am5dm5ts made by ?is title %all take effect on ,octob] #a1 #bjbb1 or ! date ( ! enactm5t ( ?is ,act1 :i*ev] is lat]1 except t fees "u "p #g ( sub*apt] ,c ( *apt] ,,vii ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;j-#da et seq47 %all be assess$ = all abbreviat$ new drug applications receiv$ on or aft] ,octob] #a1 #bjbb1 reg>dless ( ! date ( ! enactm5t ( ?is ,act4 #cjjf4 ,sav+s clause ,not)/&+ ! am5dm5ts made by ?is title1 "p #g ( sub*apt] ,c ( *apt] ,,vii ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;j-#da et seq471 z 9 effect on ! day be=e ! date ( ! enactm5t ( ?is title1 %all cont9ue to be 9 effect ) respect to abbreviat$ new drug applications 7z def9$ 9 su* "p z ( su* day7 t 7 receiv$ by ! ,food & ,drug ,adm9i/ration )9 ! mean+ ( section #eje7;j77#e77;,a7 ( su* ,act 7#ba ,u4,s4,c4 #cee7;j77#e77;,a771 prior approval supplem5ts t 7 submitt$1 & drug ma/] files = ,type ,,ii active ph>maceutical +r$i5ts t 7 fir/ ref]5c$ on or aft] ,octob] #a1 #bjag1 b be=e ,octob] #a1 #bjbb1 ) respect to assess+ & collect+ any fee requir$ by su* "p = a fiscal ye> prior to fiscal ye> #bjbc4 ,,iv ,fees ,relat+ to ,biosimil> ,biological ,products #djja4 ,%ort title2 f9d+ 7a7 ,%ort ,title ,?is title may be cit$ z ! ,biosimil> ,us] ,fee ,am5dm5ts ( #bjbb4 7b7 ,f9d+ ,congress f9ds t ! fees au?oriz$ by ! am5dm5ts made by ?is title w be d$icat$ to exp$it+ ! process = ! review ( biosimil> biological product applications1 includ+ po/m>ket safety activities1 z set =? 9 ! goals id5tifi$ = purposes ( "p #h ( sub*apt] ,c ( *apt] ,,vii ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;j-#ea et seq471 9 ! lett]s f ! ,secret>y ( ,heal? & ,human ,s]vices to ! ,*airman ( ! ,committee on ,heal?1 ,education1 ,labor1 & ,p5sions ( ! ,s5ate & ! ,*airman ( ! ,committee on ,en]gy & ,comm]ce ( ! ,h\se ( ,repres5tatives1 z set =? 9 ! ,congressional ,record4 #djjb4 ,def9itions 7a7 ,adju/m5t factor ,section #gdd;,g7#a7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;j-#ea7a77 is am5d$ to read z foll[s3 7#a7 ,! t]m adju/m5t factor applicable to a fiscal ye> is ! ,consum] ,price ,index = urban consum]s 7,wa%+ton-,arl+ton-,alex&ria1 ,,dc-,,va-,,md-,,wv2 ,n ,seasonally ,adju/$2 ,all items7 = ,septemb] ( ! prec$+ fiscal ye> divid$ by su* ,index = ,septemb] #bjaa4 4 7b7 ,biosimil> biological product application ,section #gdd;,g7#d77;,b77iii7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;j-#ea7d77;,b77iii77 is am5d$-- 7#a7 by /rik+ subclause 7,,ii7 7relat+ to an all]g5ic extract product72 & 7#b7 by r$esignat+ subclauses 7,,iii7 & 7,,iv7 z subclauses 7,,ii7 & 7,,iii71 respectively4 #djjc4 ,au?ority to assess & use biosimil> biological product fees 7a7 ,types ( fees 7#a7 ,9 g5]al ,! matt] prec$+ p>agraph 7#a7 9 section #gdd;,h7a7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;j-#eb7;a77 is am5d$ by /rik+ fiscal ye> #bjah & ins]t+ fiscal ye> #bjbc4 7#b7 ,initial biosimil> biological product developm5t fee ,clauses 7iv77,i7 & 7v77,,ii7 ( section #gdd;,h7a77#a77;,a7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;j-#eb7;a77#a77;,a77 are ea* am5d$ by /rik+ #e days & ins]t+ #g days4 7#c7 ,annual biosimil> biological product developm5t fee ,section #gdd;,h7a77#a77;,b7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;j-#eb7;a77#a77;,b77 is am5d$-- 7,a7 9 clause 7i71 by ins]t+ be=e ! p]iod at ! end ! foll[+3 1 except t1 9 ! case t su* product 7includ+1 :]e applicable1 own]%ip ( ! relevant inve/igational new drug application7 is transf]r$ to a lic5see1 assignee1 or successor ( su* p]son1 & writt5 notice ( su* transf] is provid$ to ! ,secret>y1 su* lic5see1 assignee1 or successor %all pay ! annual biosimil> biological product developm5t fee2 7,b7 9 clause 7iii7-- 7i7 9 subclause 7,i71 by /rik+ or at ! end2 7ii7 9 subclause 7,,ii71 by /rik+ ! p]iod at ! end & ins]t+ 2 or2 & 7iii7 by add+ at ! end ! foll[+3 7,,iii7 be5 adm9i/ratively remov$ f ! biosimil> biological product developm5t program = ! product "u subp>agraph 7,e77v74 2 & 7,c7 9 clause 7iv71 by /rik+ is accept$ = fil+ on or aft] ,octob] #a ( su* fiscal ye> & ins]t+ is subsequ5tly accept$ = fil+4 7#d7 ,reactivation fee ,section #gdd;,h7a77#a77;,d7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;j-#eb7;a77#a77;,d77 is am5d$ to read z foll[s3 7,d7 ,reactivation fee 7i7 ,9 g5]al ,a p]son t has discont9u$ p>ticipation 9 ! biosimil> biological product developm5t program = a product "u subp>agraph 7,c71 or :o has be5 adm9i/ratively remov$ f su* program = a product "u subp>agraph 7,e77v71 %all1 if ! p]son seeks to resume p>ticipation 9 su* program1 pay all annual biosimil> biological product developm5t fees previ\sly assess$ = su* product & /ill ow$ & a fee 7ref]r$ to 9 ?is section z reactivation fee7 by ! e>li] ( ! foll[+3 7,i7 ,n lat] ?an #g days aft] ! ,secret>y grants a reque/ by su* p]son = a biosimil> biological product developm5t meet+ = ! product 7aft] ! date on :i* su* p>ticipation 0 discont9u$ or ! date ( adm9i/rative removal1 z applicable74 7,,ii7 ,^u ! date ( submission 7aft] ! date on :i* su* p>ticipation 0 discont9u$ or ! date ( adm9i/rative removal1 z applicable7 by su* p]son ( an inve/igational new drug application describ+ an inve/igation t ! ,secret>y det]m9es is int5d$ to support a biosimil> biological product application = t product4 7ii7 ,application ( annual fee ,a p]son t pays a reactivation fee = a product %all pay = su* product1 beg9n+ 9 ! next fiscal ye>1 ! annual biosimil> biological product developm5t fee "u subp>agraph 7,b71 except t1 9 ! case t su* product 7includ+1 :]e applicable1 own]%ip ( ! relevant inve/igational new drug application7 is transf]r$ to a lic5see1 assignee1 or successor ( su* p]son1 & writt5 notice ( su* transf] is provid$ to ! ,secret>y1 su* lic5see1 assignee1 or successor %all pay ! annual biosimil> biological product developm5t fee4 4 7#e7 ,effect ( failure to pay fees ,section #gdd;,h7a77#a77;,e7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;j-#eb7;a77#a77;,e77 is am5d$ by add+ at ! end ! foll[+3 7v7 ,adm9i/rative removal f ! biosimil> biological product developm5t program ,if a p]son has fail$ to pay an annual biosimil> biological product developm5t fee = a product z requir$ "u subp>agraph 7,b7 = a p]iod ( #b consecutive fiscal ye>s1 ! ,secret>y may adm9i/ratively remove su* p]son f ! biosimil> biological product developm5t program = ! product4 ,at lea/ #cj days prior to adm9i/ratively remov+ a p]son f ! biosimil> biological product developm5t program = a product "u ?is clause1 ! ,secret>y %all provide writt5 notice to su* p]son ( ! int5d$ adm9i/rative removal4 4 7#f7 ,biosimil> biological product application fee ,section #gdd;,h7a77#b77;,d7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;j-#eb7;a77#b77;,d77 is am5d$ by ins]t+ aft] or 0 )drawn ! foll[+3 prior to approval4 7#g7 ,biosimil> biological product program fee ,section #gdd;,h7a77#c7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;j-#eb7;a77#c77 is am5d$-- 7,a7 9 subp>agraph 7,a7-- 7i7 9 clause 7i71 by /rik+ & at ! end2 7ii7 by r$esignat+ clause 7ii7 z clause 7iii72 & 7iii7 by ins]t+ aft] clause 7i7 ! foll[+3 7ii7 may be disp5s$ only "u prescription pursuant to section #ejc7;b72 & 2 & 7,b7 by add+ at ! end ! foll[+3 7,e7 ,movem5t to discont9u$ li/ 7i7 ,date ( inclusion ,if a writt5 reque/ to place a product on ! li/ ref]5c$ 9 subp>agraph 7,a7 ( discont9u$ biosimil> biological products is submitt$ to ! ,secret>y on behalf ( an applicant1 & ! reque/ id5tifies ! date ! product is1 or w be1 )drawn f sale1 !n = purposes ( assess+ ! biosimil> biological product program fee1 ! ,secret>y %all consid] su* product to h be5 includ$ on su* li/ on ! lat] (-- 7,i7 ! date su* reque/ 0 receiv$2 or 7,,ii7 if ! product w be )drawn f sale on a future date1 su* future date :5 ! product is )drawn f sale4 7ii7 ,treatm5t z )drawn f sale ,= purposes ( clause 7i71 a product %all be consid]$ )drawn f sale once ! applicant has ceas$ its own di/ribution ( ! product1 :e!r or n ! applicant has ord]$ recall ( all previ\sly di/ribut$ lots ( ! product1 except t a r\t9e1 tempor>y int]ruption 9 supply %all n r5d] a product )drawn f sale4 7iii7 ,special rule = products remov$ f discont9u$ li/ ,if a biosimil> biological product t is id5tifi$ 9 a biosimil> biological product application approv$ z ( ,octob] #a ( a fiscal ye> appe>s1 z ( ,octob] #a ( su* fiscal ye>1 on ! li/ ref]5c$ 9 subp>agraph 7,a7 ( discont9u$ biosimil> biological products1 & on any subsequ5t day dur+ su* fiscal ye> ! biosimil> biological product does n appe> on su* li/1 except z provid$ 9 subp>agraph 7,d71 ea* p]son :o is nam$ z ! applicant 9 a biosimil> biological product application ) respect to su* product %all pay ! annual biosimil> biological product program fee e/abli%$ = a fiscal ye> "u subsection 7c77#e7 = su* biosimil> biological product4 ,not)/&+ subp>agraph 7,b71 su* fee %all be due on ! la/ bus9ess day ( su* fiscal ye> & %all be paid only once = ea* su* product = ea* fiscal ye>4 4 7#h7 ,biosimil> biological product fee ,section #gdd;,h7a7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;j-#eb7;a77 is am5d$ by /rik+ p>agraph 7#d74 7b7 ,fee rev5ue am\nts ,subsection 7b7 ( section #gdd;,h ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;j-#eb7 is am5d$-- 7#a7 by /rik+ p>agraph 7#a72 7#b7 by r$esignat+ p>agraphs 7#b7 ?r\gh 7#d7 z p>agraphs 7#a7 ?r\gh 7#c71 respectively2 7#c7 by am5d+ p>agraph 7#a7 7z s r$esignat$7 to read z foll[s3 7#a7 ,9 g5]al ,= ea* ( ! fiscal ye>s #bjbc ?r\gh #bjbg1 fees "u subsection 7a7 %all1 except z provid$ 9 subsection 7c71 be e/abli%$ to g5]ate a total rev5ue am\nt equal to ! sum (-- 7,a7 ! annual base rev5ue = ! fiscal ye> 7z det]m9$ "u p>agraph 7#c772 7,b7 ! doll> am\nt equal to ! inflation adju/m5t = ! fiscal ye> 7z det]m9$ "u subsection 7c77#a772 7,c7 ! doll> am\nt equal to ! /rategic hir+ & ret5tion adju/m5t 7z det]m9$ "u subsection 7c77#b772 7,d7 ! doll> am\nt equal to ! capacity plann+ adju/m5t = ! fiscal ye> 7z det]m9$ "u subsection 7c77#c772 7,e7 ! doll> am\nt equal to ! op]at+ res]ve adju/m5t = ! fiscal ye>1 if applicable 7z det]m9$ "u subsection 7c77#d772 7,f7 = fiscal ye> #bjbc an additional am\nt ( #d1dbh1hhf2 & 7,g7 = fiscal ye> #bjbd an additional am\nt ( #cbj1efi4 2 7#d7 9 p>agraph 7#b7 7z s r$esignat$7-- 7,a7 9 ! p>agraph head+1 by /rik+ 2 limitations on fee am\nts2 7,b7 by /rik+ subp>agraph 7,b72 & 7,c7 by r$esignat+ subp>agraphs 7,c7 & 7,d7 z subp>agraphs 7,b7 & 7,c71 respectively2 & 7#e7 by am5d+ p>agraph 7#c7 7z s r$esignat$7 to read z foll[s3 7#c7 ,annual base rev5ue ,= purposes ( p>agraph 7#a71 ! doll> am\nt ( ! annual base rev5ue = a fiscal ye> %all be-- 7,a7 = fiscal ye> #bjbc1 #dc1cgf1ibb2 & 7,b7 = fiscal ye>s #bjbd ?r\gh #bjbg1 ! doll> am\nt ( ! total rev5ue am\nt e/abli%$ "u p>agraph 7#a7 = ! previ\s fiscal ye>1 exclud+ any adju/m5ts to su* rev5ue am\nt "u subsection 7c77#d74 4 7c7 ,adju/m5ts2 annual fee sett+ ,section #gdd;,h7c7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;j-#eb7;c77 is am5d$-- 7#a7 9 p>agraph 7#a7-- 7,a7 9 subp>agraph 7,a7-- 7i7 9 ! matt] prec$+ clause 7i71 by /rik+ subsection 7b77#b77;,b7 & ins]t+ subsection 7b77#a77;,b72 & 7ii7 9 clause 7i71 by /rik+ subsection 7b7 & ins]t+ subsection 7b77#a77;,a72 & 7,b7 9 subp>agraph 7,b77ii71 by /rik+ ,wa%+ton-,baltimore1 ,,dc-,,md-,,va-,,wv & ins]t+ ,wa%+ton-,arl+ton-,alex&ria1 ,,dc-,,va-,,md-,,wv2 7#b7 by /rik+ p>agraphs 7#b7 ?r\gh 7#d7 & ins]t+ ! foll[+3 7#b7 ,/rategic hir+ & ret5tion adju/m5t ,= ea* fiscal ye>1 aft] ! annual base rev5ue "u subsection 7b77#a77;,a7 is adju/$ = inflation 9 accordance ) p>agraph 7#a71 ! ,secret>y %all fur!r increase ! fee rev5ue & fees by #aej1jjj4 7#c7 ,capacity plann+ adju/m5t 7,a7 ,9 g5]al ,= ea* fiscal ye>1 ! ,secret>y %all1 9 addition to ! adju/m5ts "u p>agraphs 7#a7 & 7#b71 fur!r adju/ ! fee rev5ue & fees "u ?is section = a fiscal ye> to reflect *anges 9 ! res\rce capacity ne$s ( ! ,secret>y = ! process = ! review ( biosimil> biological product applications4 7,b7 ,me?odology ,= purposes ( ?is p>agraph1 ! ,secret>y %all employ ! capacity plann+ me?odology utiliz$ by ! ,secret>y 9 sett+ fees = fiscal ye> #bjba1 z describ$ 9 ! notice titl$ ,biosimil> ,us] ,fee ,rates = ,fiscal ,ye> #bjba publi%$ 9 ! ,f$]al ,regi/] on ,augu/ #d1 #bjbj 7#he ,f$4 ,reg4 #dgbbj74 ,! workload categories us$ 9 apply+ su* me?odology 9 =eca/+ %all include only ! activities describ$ 9 t notice &1 z feasible1 additional activities t are directly relat$ to ! direct review ( biosimil> biological product applications & supplem5ts1 includ+ additional =mal meet+ types1 ! direct review ( po/m>ket+ commitm5ts & requirem5ts1 ! direct review ( risk evaluation & mitigation /rategies1 & ! direct review ( annual reports = approv$ biosimil> biological products4 ,subject to ! exceptions 9 ! prec$+ s5t5ce1 ! ,secret>y %all n include z workload categories 9 apply+ su* me?odology 9 =eca/+ any non-core review activities1 includ+ ^? activities t ! ,secret>y ref]5c$ = pot5tial future use 9 su* notice b did n utilize 9 sett+ fees = fiscal ye> #bjba4 7,c7 ,limitations ,"u no circum/ances %all an adju/m5t "u ?is p>agraph result 9 fee rev5ue = a fiscal ye> t is less ?an ! sum ( ! am\nts "u subsections 7b77#a77;,a7 7! annual base rev5ue = ! fiscal ye>71 7b77#a77;,b7 7! doll> am\nt ( ! inflation adju/m5t = ! fiscal ye>71 & 7b77#a77;,c7 7! doll> am\nt ( ! /rategic hir+ & ret5tion adju/m5t74 7,d7 ,publication 9 ,f$]al ,regi/] ,! ,secret>y %all publi% 9 ! ,f$]al ,regi/] notice "u p>agraph 7#e7 ! fee rev5ue & fees result+ f ! adju/m5t & ! me?odologies "u ?is p>agraph4 7#d7 ,op]at+ res]ve adju/m5t 7,a7 ,increase ,= fiscal ye> #bjbc & subsequ5t fiscal ye>s1 ! ,secret>y %all1 9 addition to adju/m5ts "u p>agraphs 7#a71 7#b71 & 7#c71 fur!r increase ! fee rev5ue & fees if su* an adju/m5t is necess>y to provide = at lea/ #aj weeks ( op]at+ res]ves ( c>ryov] us] fees = ! process = ! review ( biosimil> biological product applications4 7,b7 ,decrease 7i7 ,fiscal ye> #bjbc ,= fiscal ye> #bjbc1 if ! ,secret>y has c>ryov] balances = su* process 9 excess ( #cc weeks ( su* op]at+ res]ves1 ! ,secret>y %all decrease su* fee rev5ue & fees to provide = n m ?an #cc weeks ( su* op]at+ res]ves4 7ii7 ,fiscal ye> #bjbd ,= fiscal ye> #bjbd1 if ! ,secret>y has c>ryov] balances = su* process 9 excess ( #bg weeks ( su* op]at+ res]ves1 ! ,secret>y %all decrease su* fee rev5ue & fees to provide = n m ?an #bg weeks ( su* op]at+ res]ves4 7iii7 ,fiscal ye> #bjbe & subsequ5t fiscal ye>s ,= fiscal ye> #bjbe & subsequ5t fiscal ye>s1 if ! ,secret>y has c>ryov] balances = su* process 9 excess ( #ba weeks ( su* op]at+ res]ves1 ! ,secret>y %all decrease su* fee rev5ue & fees to provide = n m ?an #ba weeks ( su* op]at+ res]ves4 7,c7 ,f$]al ,regi/] notice ,if an adju/m5t "u subp>agraph 7,a7 or 7,b7 is made1 ! rationale = ! am\nt ( ! increase or decrease 7z applicable7 9 fee rev5ue & fees %all be conta9$ 9 ! annual ,f$]al ,regi/] notice "u p>agraph 7#e77;,b7 e/abli%+ fee rev5ue & fees = ! fiscal ye> involv$4 2 & 7#c7 9 p>agraph 7#e71 9 ! matt] prec$+ subp>agraph 7,a71 by /rik+ #bjah & ins]t+ #bjbc4 7d7 ,cr$it+ & availability ( fees ,subsection 7f77#c7 ( section #gdd;,h ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;j-#eb7;f77#c77 is am5d$ by /rik+ #bjah ?r\gh #bjbb & ins]t+ #bjbc ?r\gh #bjbg4 7e7 ,writt5 reque/s = waiv]s & returns2 disputes conc]n+ fees ,section #gdd;,h7h7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;j-#eb7;h77 is am5d$ to read z foll[s3 7h7 ,writt5 reque/s = waiv]s & returns2 disputes conc]n+ fees ,to qualify = consid]ation = a waiv] "u subsection 7d71 or = ! return ( any fee paid "u ?is section1 includ+ if ! fee is claim$ to h be5 paid 9 error1 a p]son %all submit to ! ,secret>y a writt5 reque/ ju/ify+ su* waiv] or return &1 except z o!rwise specifi$ 9 ?is section1 su* writt5 reque/ %all be submitt$ to ! ,secret>y n lat] ?an #ahj days aft] su* fee is due4 ,a reque/ submitt$ "u ?is p>agraph %all include any legal au?orities "u :i* ! reque/ is made4 4 #djjd4 ,reau?orization2 report+ requirem5ts ,section #gdd;,i ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;j-#ec7 is am5d$-- 7#a7 9 subsection 7a77#a71 by /rik+ ,beg9n+ ) fiscal ye> #bjah1 n & ins]t+ ,n2 7#b7 by /rik+ ,biosimil> ,us] ,fee ,am5dm5ts ( #bjag ea* place x appe>s & ins]t+ ,biosimil> ,us] ,fee ,am5dm5ts ( #bjbb2 7#c7 9 subsection 7a77#b71 by /rik+ ,beg9n+ ) fiscal ye> #bjah1 ! & ins]t+ ,!2 7#d7 9 subsection 7a77#c77;,a71 by /rik+ ,n lat] ?an #cj cal5d> days aft] ! end ( ! second qu>t] ( fiscal ye> #bjah1 & n lat] ?an #cj cal5d> days aft] ! end ( ea* qu>t] ( ea* fiscal ye> !reaft] & ins]t+ ,n lat] ?an #cj cal5d> days aft] ! end ( ea* qu>t] ( ea* fiscal ye> = :i* fees are collect$ "u ?is "p2 7#e7 9 subsection 7b71 by /rik+ ,n lat] ?an #abj days aft] ! end ( fiscal ye> #bjah & ea* subsequ5t fiscal ye> = :i* fees are collect$ "u ?is "p & ins]t+ ,n lat] ?an #abj days aft] ! end ( ea* fiscal ye> = :i* fees are collect$ "u ?is "p2 7#f7 9 subsection 7c71 by /rik+ ,beg9n+ ) fiscal ye> #bjah1 & = & ins]t+ ,=2 & 7#g7 9 subsection 7f7-- 7,a7 9 p>agraph 7#a71 9 ! matt] prec$+ subp>agraph 7,a71 by /rik+ fiscal ye> #bjbb & ins]t+ fiscal ye> #bjbg2 & 7,b7 9 p>agraph 7#c71 by /rik+ ,janu>y #ae1 #bjbb & ins]t+ ,janu>y #ae1 #bjbg4 #djje4 ,sunset dates 7a7 ,au?orization ,sections #gdd;,g & #gdd;,h ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;j-#ea1 #cgi;j-#eb7 %all cease to be effective ,octob] #a1 #bjbg4 7b7 ,report+ ,requirem5ts ,section #gdd;,i ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;j-#ec7 %all cease to be effective ,janu>y #ca1 #bjbh4 7c7 ,previ\s ,sunset ,provision ,effective ,octob] #a1 #bjbb1 subsections 7a7 & 7b7 ( section #dje ( ! ,,fda ,reau?orization ,act ( #bjag 7,public ,law #aae-eb7 are repeal$4 #djjf4 ,effective date ,! am5dm5ts made by ?is title %all take effect on ,octob] #a1 #bjbb1 or ! date ( ! enactm5t ( ?is ,act1 :i*ev] is lat]1 except t fees "u "p #h ( sub*apt] ,c ( *apt] ,,vii ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;j-#ea et seq47 %all be assess$ = all biosimil> biological product applications receiv$ on or aft] ,octob] #a1 #bjbb1 reg>dless ( ! date ( ! enactm5t ( ?is ,act4 #djjg4 ,sav+s clause ,not)/&+ ! am5dm5ts made by ?is title1 "p #h ( sub*apt] ,c ( *apt] ,,vii ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;j-#ea et seq471 z 9 effect on ! day be=e ! date ( ! enactm5t ( ?is title1 %all cont9ue to be 9 effect ) respect to biosimil> biological product applications & supplem5ts 7z def9$ 9 su* "p z ( su* day7 t 7 accept$ by ! ,food & ,drug ,adm9i/ration = fil+ on or aft] ,octob] #a1 #bjag1 b be=e ,octob] #a1 #bjbb1 ) respect to assess+ & collect+ any fee requir$ by su* "p = a fiscal ye> prior to fiscal ye> #bjbc4 ,v ,reau?orization ( o!r provisions #ejja4 ,reau?orization ( ! be/ ph>maceuticals = *ildr5 program ,section #dji;,i7d77#a7 ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bhdm7d77#a77 is am5d$ by /rik+ #be1jjj1jjj = ea* ( fiscal ye>s #bjah ?r\gh #bjbb & ins]t+ #e1bgc1igc = ! p]iod beg9n+ on ,octob] #a1 #bjbb & end+ on ,decemb] #af1 #bjbb4 #ejjb4 ,reau?orization ( ! humanit>ian device exemption inc5tive ,section #ebj7m77#f77;,a77iv7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;j7m77#f77;,a77iv77 is am5d$ by /rik+ ,octob] #a & ins]t+ ,decemb] #ag4 #ejjc4 ,reau?orization ( ! p$iatric device consortia program ,section #cje7;e7 ( ! ,food & ,drug ,adm9i/ration ,am5dm5ts ,act ( #bjjg 7,public ,law #aaj-he2 #db ,u4,s4,c4 #bhb note7 is am5d$ by /rik+ #e1bej1jjj = ea* ( fiscal ye>s #bjah ?r\gh #bjbb & ins]t+ #a1ajg1ecd = ! p]iod beg9n+ on ,octob] #a1 #bjbb1 & end+ on ,decemb] #af1 #bjbb4 #ejjd4 ,reau?orization ( provision p]ta9+ to drugs conta9+ s+le enantiom]s ,section #eje7u77#d7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cee7u77#d77 is am5d$ by /rik+ ,octob] #a & ins]t+ ,decemb] #ag4 #ejje4 ,reau?orization ( ! critical pa? public-private p>tn]%ip ,section #eff7;f7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;bbb-#e7;f77 is am5d$ by /rik+ #f1jjj1jjj = ea* ( fiscal ye>s #bjah ?r\gh #bjbb & ins]t+ #a1bfe1gec = ! p]iod beg9n+ on ,octob] #a1 #bjbb & end+ on ,decemb] #af1 #bjbb4 #ejjf4 ,reau?orization ( orphan drug grants ,section #e7;c7 ( ! ,orphan ,drug ,act 7#ba ,u4,s4,c4 #cfj;ee7c77 is am5d$ by /rik+ #cj1jjj1jjj = ea* ( fiscal ye>s #bjah ?r\gh #bjbb & ins]t+ #f1cbh1gfg = ! p]iod beg9n+ on ,octob] #a1 #bjbb1 & end+ on ,decemb] #af1 #bjbb4 #ejjg4 ,reau?orization ( c]ta9 device inspections ,section #gjd7;g77#aa7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cgd7;g77#aa77 is am5d$ by /rik+ ,octob] #a & ins]t+ ,decemb] #ag4 #ejjh4 ,reau?orization ( report+ requirem5ts relat$ to p5d+ g5]ic drug applications & priority review applications ,section #hjg ( ! ,,fda ,reau?orization ,act ( #bjag 7,public ,law #aae-eb7 is am5d$1 9 ! matt] prec$+ p>agraph 7#a71 by /rik+ ,octob] #a & ins]t+ ,decemb] #af4 ,g ,h]mit's ,peak_/,calf ,canyon ,fire ,assi/ance ,act #aja4 ,%ort title ,?is division may be cit$ z ! ,h]mit's ,peak_/,calf ,canyon ,fire ,assi/ance ,act4 #ajb4 ,f9d+s & purposes 7a7 ,f9d+s ,congress f9ds t-- 7#a7 on ,april #f1 #bjbb1 ! ,=e/ ,s]vice initiat$ ! ,las ,disp5sas-,gall9as prescrib$ burn on ,f$]al l& 9 ! ,santa ,fe ,national ,=e/ 9 ,san ,miguel ,c\nty1 ,new ,mexico1 :5 erratic w9ds 7 preval5t 9 ! area t 0 also suff]+ f sev]e dr\ght aft] _m ye>s ( insuffici5t precipitation2 7#b7 on ,april #f1 #bjbb1 ! prescrib$ burn1 :i* became kn[n z ! ,h]mit's ,peak ,fire1 exce$$ ! conta9m5t capabilities ( ! ,=e/ ,s]vice1 0 decl>$ a wildfire1 & spread to o!r ,f$]al & non-,f$]al l&2 7#c7 on ,april #ai1 #bjbb1 ! ,calf ,canyon ,fire1 also 9 ,san ,miguel ,c\nty1 ,new ,mexico1 began burn+ on ,f$]al l& & 0 lat] id5tifi$ z ! result ( a pile burn 9 ,janu>y #bjbb t rema9$ dormant "u ! surface be=e reem]g+2 7#d7 on ,april #bg1 #bjbb1 ! ,h]mit's ,peak ,fire & ! ,calf ,canyon ,fire m]g$1 & bo? fires 7 report$ z ! ,h]mit's ,peak ,fire or ! ,h]mit's ,peak_/,calf ,canyon ,fire1 :i* %all be ref]r$ to h]eaft] z ! ,h]mit's ,peak_/,calf ,canyon ,fire2 7#e7 by ,may #b1 #bjbb1 ! fire _h gr[n 9 size & caus$ evacuations 9 multiple villages & communities 9 ,san ,miguel ,c\nty & ,mora ,c\nty1 includ+ 9 ! ,san ,miguel c\nty jail1 ! ,/ate's psy*iatric hospital1 ! ,unit$ ,_w ,college1 & ,new ,mexico ,highl&s ,univ]sity2 7#f7 on ,may #d1 #bjbb1 ! ,presid5t issu$ a major disa/] decl>ation = ! c\nties ( ,colfax1 ,mora1 & ,san ,miguel1 ,new ,mexico2 7#g7 on ,may #bj1 #bjbb1 ,u4,s4 ,=e/ ,s]vice ,*ief ,r&y ,moore ord]$ a #ij-;day review ( prescrib$ burn policies to r$uce ! risk ( wildfires & ensure ! safety ( ! communities involv$2 7#h7 ! ,u4,s4 ,=e/ ,s]vice has assum$ responsibility = ! ,h]mit's ,peak_/,calf ,canyon ,fire2 7#i7 ! fire result$ 9 ! loss ( ,f$]al1 ,/ate1 local1 ,tribal1 & private prop]ty2 & 7#aj7 ! ,unit$ ,/ates %\ld comp5sate ! victims ( ! ,h]mit's ,peak_/,calf ,canyon ,fire4 7b7 ,purposes ,! purposes ( ?is ,act are-- 7#a7 to comp5sate victims ( ! ,h]mit's ,peak_/,calf ,canyon ,fire1 = injuries result+ f ! fire2 & 7#b7 to provide = ! exp$iti\s consid]ation & settlem5t ( claims = ^? injuries4 #ajc4 ,def9itions ,9 ?is ,act3 7#a7 ,adm9i/rator ,! t]m ,adm9i/rator means-- 7,a7 ! ,adm9i/rator ( ! ,f$]al ,em]g5cy ,managem5t ,ag5cy2 or 7,b7 if a ,manag] is appo9t$ "u section #ajd7;a77#c71 ! ,manag]4 7#b7 ,h]mit's peak_/calf canyon fire ,! t]m ,h]mit's ,peak_/,calf ,canyon ,fire means-- 7,a7 ! fire result+ f ! initiation by ! ,=e/ ,s]vice ( a prescrib$ burn 9 ! ,santa ,fe ,national ,=e/ 9 ,san ,miguel ,c\nty1 ,new ,mexico1 on ,april #f1 #bjbb2 7,b7 ! pile burn holdov] result+ f ! prescrib$ burn by ! ,=e/ ,s]vice1 :i* reem]g$ on ,april #ai1 #bjbb2 & 7,c7 ! m]g] ( ! two fires describ$ 9 subp>agraphs 7,a7 & 7,b71 report$ z ! ,h]mit's ,peak ,fire or ! ,h]mit's ,peak ,fire_/,calf ,canyon ,fire4 7#c7 ,indian tribe ,! t]m ,indian ,tribe means ! recogniz$ gov]n+ body ( any ,indian or ,alaska ,native ,tribe1 b&1 nation1 pueblo1 village1 community1 compon5t b&1 or compon5t res]vation individually id5tifi$ 7includ+ p>5!tically7 9 ! li/ publi%$ mo/ rec5tly z ( ! date ( enactm5t ( ?is ,act pursuant to section #ajd ( ! ,f$]ally ,recogniz$ ,indian ,tribe ,li/ ,act ( #aiid 7#be ,u4,s4,c4 #eaca74 7#d7 ,injur$ p]son ,! t]m injur$ p]son means-- 7,a7 an individual1 reg>dless ( ! citiz5%ip or ali5 /atus ( ! individual2 or 7,b7 an ,indian ,tribe1 corporation1 ,tribal corporation1 p>tn]%ip1 company1 association1 c\nty1 t[n%ip1 city1 ,/ate1 s*ool di/rict1 or o!r non-,f$]al entity 7includ+ a legal repres5tative7 t suff]$ injury result+ f ! ,h]mit's ,peak_/,calf ,canyon ,fire4 7#e7 ,injury ,! t]m injury has ! same mean+ z ! t]m injury or loss ( prop]ty1 or p]sonal injury or dea? z us$ 9 section #acdf7;b77#a7 ( title #bh1 ,unit$ ,/ates ,code4 7#f7 ,manag] ,! t]m ,manag] means an ,indep5d5t ,claims ,manag] appo9t$ "u section #ajd7;a77#c74 7#g7 ,(fice ,! t]m ,(fice means ! ,(fice ( ,h]mit's ,peak_/,calf ,canyon ,fire ,claims e/abli%$ by section #ajd7;a77#b74 7#h7 ,tribal entity ,! t]m ,tribal entity includes any ,indian ,tribe1 tribal organization1 ,indian-controll$ organization s]v+ ,indians1 ,native ,hawaiian organization1 or ,alaska ,native entity1 z su* t]ms are def9$ or us$ 9 section #aff ( ! ,work=ce ,innovation & ,opportunity ,act 7#bi ,u4,s4,c4 #cbba74 #ajd4 ,comp5sation = victims ( h]mit's peak_/calf canyon fire 7a7 ,9 g5]al 7#a7 ,comp5sation ,ea* injur$ p]son %all be eligible to receive f ! ,unit$ ,/ates comp5sation = injury suff]$ by ! injur$ p]son z a result ( ! ,h]mit's ,peak_/,calf ,canyon ,fire1 subject to ! availability ( appropriations & subject to ! ,adm9i/rator mak+ ! det]m9ations requir$ "u subsection 7d74 7#b7 ,(fice ( h]mit's peak_/calf canyon fire claims 7,a7 ,9 g5]al ,!re is e/abli%$ )9 ! ,f$]al ,em]g5cy ,managem5t ,ag5cy an ,(fice ( ,h]mit's ,peak_/,calf ,canyon ,fire ,claims4 7,b7 ,purpose ,! ,(fice %all receive1 process1 & pay claims 9 accordance ) ?is ,act4 7,c7 ,fund+ ,! ,(fice-- 7i7 %all be fund$ f funds made available to ! ,adm9i/rator = c>ry+ out ?is section2 7ii7 may appo9t & fix ! comp5sation ( su* tempor>y p]sonnel z may be necess>y1 )\t reg>d to ! provisions ( title #e1 ,unit$ ,/ates ,code1 gov]n+ appo9tm5ts 9 competitive s]vice2 & 7iii7 may reimburse o!r ,f$]al ag5cies = claims process+ support & assi/ance4 7#c7 ,option to appo9t indep5d5t claims manag] ,! ,adm9i/rator may appo9t an ,indep5d5t ,claims ,manag] to-- 7,a7 head ! ,(fice2 & 7,b7 assume ! duties ( ! ,adm9i/rator "u ?is ,act4 7#d7 ,detail ,^u ! reque/ ( ! ,adm9i/rator1 ! head ( any ,f$]al dep>tm5t or ag5cy may detail1 on a reimbursable basis1 any ( ! p]sonnel ( t dep>tm5t or ag5cy to ! ,f$]al ,em]g5cy ,managem5t ,ag5cy to assi/ ! ,ag5cy 9 c>ry+ out ! duties "u ?is ,act4 7b7 ,submission ( claims ,n lat] ?an #b ye>s aft] ! date on :i* regulations are fir/ promulgat$ "u subsection 7f71 an injur$ p]son may submit to ! ,adm9i/rator a writt5 claim = #a or m injuries suff]$ by ! injur$ p]son 9 accordance ) su* requirem5ts z ! ,adm9i/rator det]m9es to be appropriate4 7c7 ,inve/igation ( claims 7#a7 ,9 g5]al ,9 accordance ) subsection 7d71 ! ,adm9i/rator %all1 on behalf ( ! ,unit$ ,/ates1 inve/igate1 consid]1 asc]ta91 adju/1 det]m9e1 grant1 d5y1 or settle any claim = money damages ass]t$ "u subsection 7b74 7#b7 ,applicability ( /ate law ,except z o!rwise provid$ 9 ?is ,act1 ! laws ( ! ,/ate ( ,new ,mexico %all apply to ! calculation ( damages "u subsection 7d77#d74 7#c7 ,ext5t ( damages ,any paym5t "u ?is ,act-- 7,a7 %all be limit$ to actual comp5satory damages measur$ by injuries suff]$2 & 7,b7 %all n include-- 7i7 int]e/ be=e settlem5t or paym5t ( a claim2 or 7ii7 punitive damages4 7d7 ,paym5t ( claims 7#a7 ,det]m9ation & paym5t ( am\nt 7,a7 ,9 g5]al 7i7 ,paym5t ,n lat] ?an #ahj days aft] ! date on :i* a claim is submitt$ "u ?is ,act1 ! ,adm9i/rator %all det]m9e & fix ! am\nt1 if any1 to be paid = ! claim4 7ii7 ,priority ,! ,adm9i/rator1 to ! maximum ext5t practicable1 %all pay subrogation claims submitt$ "u ?is ,act only aft] pay+ claims submitt$ by injur$ p>ties t are n insurance companies seek+ paym5t z subrogees4 7,b7 ,p>amet]s ( det]m9ation ,9 det]m9+ & settl+ a claim "u ?is ,act1 ! ,adm9i/rator %all det]m9e only-- 7i7 :e!r ! claimant is an injur$ p]son2 7ii7 :e!r ! injury t is ! subject ( ! claim result$ f ! ,h]mit's ,peak_/,calf ,canyon ,fire2 7iii7 :e!r ! p]son or p]sons are o!rwise eligible to receive any am\nt det]m9$ "u clause 7iv72 & 7iv7 :e!r suffici5t funds are available = paym5t &1 if s1 ! am\nt1 if any1 to be all[$ & paid "u ?is ,act4 7,c7 ,insurance & o!r b5efits 7i7 ,9 g5]al ,9 det]m9+ ! am\nt (1 & pay+1 a claim "u ?is ,act1 to prev5t recov]y by a claimant 9 excess ( actual comp5satory damages1 ! ,adm9i/rator %all r$uce ! am\nt to be paid = ! claim by an am\nt t is equal to ! total ( insurance b5efits 7exclud+ life insurance b5efits7 or o!r paym5ts or settlem5ts ( any nature t 7 paid1 or w be paid1 ) respect to ! claim4 7ii7 ,gov]nm5t loans ,?is subp>agraph %all n apply to ! receipt by a claimant ( any gov]nm5t loan t is requir$ to be repaid by ! claimant4 7#b7 ,p>tial paym5t 7,a7 ,9 g5]al ,at ! reque/ ( a claimant1 ! ,adm9i/rator may make #a or m advance or p>tial paym5ts1 subject to ! det]m9ation requir$ "u p>agraph 7#a77;,b71 be=e ! f9al settlem5t ( a claim1 includ+ f9al settlem5t on any portion or aspect ( a claim t is det]m9$ to be sev]able4 7,b7 ,judicial decision ,if a claimant receives a p>tial paym5t on a claim "u ?is ,act1 b fur!r paym5t on ! claim is subsequ5tly d5i$ by ! ,adm9i/rator1 ! claimant may-- 7i7 seek judicial review "u subsection 7i72 & 7ii7 keep any p>tial paym5t t ! claimant receiv$1 unless ! ,adm9i/rator det]m9es t ! claimant-- 7,i7 0 n eligible to receive ! comp5sation2 or 7,,ii7 fraudul5tly procur$ ! comp5sation4 7#c7 ,rights ( insur] or o!r ?ird p>ty ,if an insur] or o!r ?ird p>ty pays any am\nt to a claimant to comp5sate = an injury describ$ 9 subsection 7a71 ! insur] or o!r ?ird p>ty %all be subrogat$ to any "r t ! claimant has to receive any paym5t "u ?is ,act or any o!r law4 7#d7 ,all[able damages 7,a7 ,loss ( prop]ty ,a claim t is paid = loss ( prop]ty "u ?is ,act may include o!rwise uncomp5sat$ damages result+ f ! ,h]mit's ,peak_/,calf ,canyon ,fire =-- 7i7 an un9sur$ or und]9sur$ prop]ty loss2 7ii7 a decrease 9 ! value ( real prop]ty2 7iii7 damage to physical infra/ructure1 includ+ irrigation infra/ructure su* z acequia sy/ems2 7iv7 a co/ result+ f lo/ subsi/5ce f hunt+1 fi%+1 firewood ga!r+1 timb]+1 graz+1 or agricultural activities conduct$ on l& damag$ by ! ,h]mit's ,peak_/,calf ,canyon ,fire2 7v7 a co/ ( re=e/ation or revegetation on ,tribal or non-,f$]al l&1 to ! ext5t t ! co/ ( re=e/ation or revegetation is n cov]$ by any o!r ,f$]al program2 & 7vi7 any o!r loss t ! ,adm9i/rator det]m9es to be appropriate = inclusion z loss ( prop]ty4 7,b7 ,bus9ess loss ,a claim t is paid = injury "u ?is ,act may include damages result+ f ! ,h]mit's ,peak_/,calf ,canyon ,fire = ! foll[+ types ( o!rwise uncomp5sat$ bus9ess loss3 7i7 ,damage to tangible assets or inv5tory1 includ+ natural res\rces4 7ii7 ,bus9ess int]ruption losses4 7iii7 ,ov]head co/s4 7iv7 ,employee wages = "w n p]=m$4 7v7 ,loss ( bus9ess net income4 7vi7 ,any o!r loss t ! ,adm9i/rator det]m9es to be appropriate = inclusion z bus9ess loss4 7,c7 ,f9ancial loss ,a claim t is paid = injury "u ?is ,act may include damages result+ f ! ,h]mit's ,peak_/,calf ,canyon ,fire = ! foll[+ types ( o!rwise uncomp5sat$ f9ancial loss3 7i7 ,increas$ mortgage int]e/ co/s4 7ii7 ,an insurance d$uctible4 7iii7 ,a tempor>y liv+ or relocation exp5se4 7iv7 ,lo/ wages or p]sonal income4 7v7 ,em]g5cy /aff+ exp5ses4 7vi7 ,debris removal & o!r cleanup co/s4 7vii7 ,co/s ( reasonable ef=ts1 z det]m9$ by ! ,adm9i/rator1 to r$uce ! risk ( wildfire1 flood1 or o!r natural disa/] 9 ! c\nties impact$ by ! ,h]mit's ,peak_/,calf ,canyon ,fire to risk levels prevail+ 9 ^? c\nties be=e ! ,h]mit's ,peak_/,calf ,canyon ,fire1 t are incurr$ n lat] ?an ! date t is #c ye>s aft] ! date on :i* ! regulations "u subsection 7f7 are fir/ promulgat$4 7viii7 ,a premium = flood insurance t is requir$ to be paid on or be=e ,may #ca1 #bjbd1 if1 z a result ( ! ,h]mit's ,peak_/,calf ,canyon ,fire1 a p]son t 0 n requir$ to pur*ase flood insurance be=e ! ,h]mit's ,peak_/,calf ,canyon ,fire is requir$ to pur*ase flood insurance4 7ix7 ,a disa/] assi/ance loan receiv$ f ! ,small ,bus9ess ,adm9i/ration4 7x7 ,any o!r loss t ! ,adm9i/rator det]m9es to be appropriate = inclusion z f9ancial loss4 7e7 ,acceptance ( aw>d ,! acceptance by a claimant ( any paym5t "u ?is ,act1 except an advance or p>tial paym5t made "u subsection 7d77#b71 %all-- 7#a7 be f9al & conclusive on ! claimant1 ) respect to all claims aris+ out ( or relat+ to ! same subject matt]2 & 7#b7 con/itute a complete release ( all claims aga9/ ! ,unit$ ,/ates 7includ+ any ag5cy or employee ( ! ,unit$ ,/ates7 "u *apt] #aga ( title #bh1 ,unit$ ,/ates ,code 7commonly kn[n z ! ,f$]al ,tort ,claims ,act71 or any o!r ,f$]al or ,/ate law1 aris+ out ( or relat+ to ! same subject matt]4 7f7 ,regulations & public in=mation 7#a7 ,regulations ,not)/&+ any o!r provision ( law1 n lat] ?an #de days aft] ! date ( enactm5t ( ?is ,act1 ! ,adm9i/rator %all promulgate & publi% 9 ! ,f$]al ,regi/] int]im f9al regulations = ! process+ & paym5t ( claims "u ?is ,act4 7#b7 ,public in=mation 7,a7 ,9 g5]al ,at ! "t at :i* ! ,adm9i/rator promulgates regulations "u p>agraph 7#a71 ! ,adm9i/rator %all publi%1 onl9e & 9 pr9t1 9 newspap]s ( g5]al circulation 9 ! ,/ate ( ,new ,mexico1 a cle>1 concise1 & easily und]/&able explanation1 9 ,engli% & ,spani%1 (-- 7i7 ! rights conf]r$ "u ?is ,act2 & 7ii7 ! proc$ural & o!r requirem5ts ( ! regulations promulgat$ "u p>agraph 7#a74 7,b7 ,dissem9ation ?r\gh o!r m$ia ,! ,adm9i/rator %all dissem9ate ! explanation publi%$ "u subp>agraph 7,a7 ?r\gh websites1 blogs1 social m$ia1 bro*ures1 pamphlets1 radio1 television1 & o!r m$ia t ! ,adm9i/rator det]m9es are likely to rea* prospective claimants4 7g7 ,consultation ,9 adm9i/]+ ?is ,act1 ! ,adm9i/rator %all consult ) ! ,secret>y ( ! ,int]ior1 ! ,secret>y ( ,en]gy1 ! ,secret>y ( ,agriculture1 ! ,adm9i/rator ( ! ,small ,bus9ess ,adm9i/ration1 o!r ,f$]al ag5cies1 & ,/ate1 local1 & ,tribal au?orities1 z det]m9$ to be necess>y by ! ,adm9i/rator1 to-- 7#a7 ensure ! effici5t adm9i/ration ( ! claims process2 & 7#b7 provide = local conc]ns4 7h7 ,election ( rem$y 7#a7 ,9 g5]al ,an injur$ p]son may elect to seek comp5sation f ! ,unit$ ,/ates = #a or m injuries result+ f ! ,h]mit's ,peak_/,calf ,canyon ,fire by-- 7,a7 submitt+ a claim "u ?is ,act2 7,b7 fil+ a claim or br++ a civil action "u *apt] #aga ( title #bh1 ,unit$ ,/ates ,code 7commonly kn[n z ! ,f$]al ,tort ,claims ,act72 or 7,c7 br++ an au?oriz$ civil action "u any o!r provision ( law4 7#b7 ,effect ( election ,9 accordance ) subsection 7e71 an election by an injur$ p]son to seek comp5sation 9 any mann] describ$ 9 p>agraph 7#a7 %all be f9al & conclusive on ! claimant ) respect to all injuries result+ f ! ,h]mit's ,peak_/,calf ,canyon ,fire t are suff]$ by ! claimant ^u acceptance ( an aw>d4 7#c7 ,arbitration 7,a7 ,9 g5]al ,n lat] ?an #de days aft] ! date ( enactm5t ( ?is ,act1 ! ,adm9i/rator %all e/abli% by regulation proc$ures "u :i* a dispute reg>d+ a claim submitt$ "u ?is ,act may be settl$ by arbitration4 7,b7 ,arbitration z rem$y ,on e/abli%m5t ( arbitration proc$ures "u subp>agraph 7,a71 an injur$ p]son t submits a disput$ claim "u ?is ,act may elect to settle ! claim ?r\gh arbitration4 7,c7 ,b9d+ effect ,an election by an injur$ p]son to settle a claim ?r\gh arbitration "u ?is p>agraph %all-- 7i7 be b9d+2 & 7ii7 preclude any ex]cise by ! injur$ p]son ( ! "r to judicial review ( a claim describ$ 9 subsection 7i74 7#d7 ,no effect on entitlem5ts ,! value ( comp5sation t may be provid$ "u ?is ,act %all n be consid]$ income or res\rces = any purpose "u any ,f$]al1 ,/ate1 or local laws1 includ+ laws relat+ to taxation1 welf>e1 & public assi/ance programs1 & no ,/ate or political subdivision !re( %all decrease any assi/ance o!rwise provid$ to an injur$ p]son because ( ! receipt ( b5efits "u ?is ,act4 7i7 ,judicial review 7#a7 ,9 g5]al ,any claimant aggriev$ by a f9al decision ( ! ,adm9i/rator "u ?is ,act may1 n lat] ?an #fj days aft] ! date on :i* ! decision is issu$1 br+ a civil action 9 ! ,unit$ ,/ates ,di/rict ,c\rt = ! ,di/rict ( ,new ,mexico1 to modify or set aside ! decision1 9 :ole or 9 "p4 7#b7 ,record ,! c\rt %all he> a civil action "u p>agraph 7#a7 on ! record made be=e ! ,adm9i/rator4 7#c7 ,/&>d ,! decision ( ! ,adm9i/rator incorporat+ ! f9d+s ( ! ,adm9i/rator %all be upheld if ! decision is support$ by sub/antial evid5ce on ! record consid]$ z a :ole4 7j7 ,attorney's & ag5t's fees 7#a7 ,9 g5]al ,no attorney or ag5t1 act+ alone or 9 comb9ation ) any o!r attorney or ag5t1 %all *>ge1 dem&1 receive1 or collect1 = s]vices r5d]$ 9 connection ) a claim submitt$ "u ?is ,act1 fees 9 excess ( ! limitations e/abli%$ "u section #bfgh ( title #bh1 ,unit$ ,/ates ,code4 7#b7 ,violation ,an attorney or ag5t :o violates p>agraph 7#a7 %all be f9$ n m ?an #aj1jjj4 7k7 ,waiv] ( requirem5t = mat*+ funds 7#a7 ,/ate & local project 7,a7 ,9 g5]al ,not)/&+ any o!r provision ( law1 a ,/ate or local project t is det]m9$ by ! ,adm9i/rator to be c>ri$ out 9 response to ! ,h]mit's ,peak_/,calf ,canyon ,fire "u any ,f$]al program t applies to an area affect$ by ! ,h]mit's ,peak_/,calf ,canyon ,fire %all n be subject to any requirem5t = ,/ate or local mat*+ funds to pay ! co/ ( ! project "u ! ,f$]al program4 7,b7 ,f$]al %>e ,! ,f$]al %>e ( ! co/s ( a project describ$ 9 subp>agraph 7,a7 %all be #ajj p]c5t4 7#b7 ,o!r ne$s program assi/ance ,not)/&+ section #djh7;g77#b7 ( ! ,rob]t ,t4 ,/af=d ,disa/] ,relief & ,em]g5cy ,assi/ance ,act 7#db ,u4,s4,c4 #eagd7;g77#b771 = any em]g5cy or major disa/] decl>$ by ! ,presid5t "u t ,act = ! ,h]mit's ,peak_/,calf ,canyon ,fire1 ! ,f$]al %>e ( assi/ance provid$ "u t section %all be #ajj p]c5t4 7#c7 ,agricultural program assi/ance 7,a7 ,9 g5]al ,not)/&+ any o!r provision ( law1 a ,/ate1 local1 or individual project t is det]m9$ by ! ,secret>y ( ,agriculture to be c>ri$ out 9 response to ! ,h]mit's ,peak_/,calf ,canyon ,fire "u any ,f$]al program t applies to an area affect$ by ! ,h]mit's ,peak_/,calf ,canyon ,fire %all n be subject to any requirem5t = ,/ate1 local1 or individual mat*+ funds to pay ! co/ ( ! project "u ! ,f$]al program4 7,b7 ,f$]al %>e ,! ,f$]al %>e ( ! co/s ( a project describ$ 9 subp>agraph 7,a7 %all be #ajj p]c5t4 7l7 ,applicability ( debt collection requirem5ts ,section #cgaa7;a7 ( title #ca1 ,unit$ ,/ates ,code1 %all n apply to any paym5t "u ?is ,act1 unless-- 7#a7 !re is evid5ce ( civil or crim9al fraud1 misrepres5tation1 pres5tation ( a false claim2 or 7#b7 a claimant 0 n eligible "u subsection 7d77#b7 ( ?is ,act to any p>tial paym5t4 7m7 ,indian comp5sation ,not)/&+ any o!r provision ( law1 9 ! case ( an ,indian ,tribe1 a ,tribal entity1 or a memb] ( an ,indian ,tribe t submits a claim "u ?is ,act-- 7#a7 ! ,bureau ( ,indian ,affairs %all h no au?ority ov]1 or any tru/ obligation reg>d+1 any aspect ( ! submission (1 or any paym5t receiv$ =1 ! claim2 7#b7 ! ,indian ,tribe1 ,tribal entity1 or memb] ( an ,indian ,tribe %all be entitl$ to proce$ "u ?is ,act 9 ! same mann] & to ! same ext5t z any o!r injur$ p]son2 & 7#c7 except ) respect to l& damag$ by ! ,h]mit's ,peak_/,calf ,canyon ,fire t is ! subject ( ! claim1 ! ,bureau ( ,indian ,affairs %all h no responsibility to re/ore l& damag$ by ! ,h]mit's ,peak_/,calf ,canyon ,fire4 7n7 ,report ,n lat] ?an #a ye> aft] ! date ( promulgation ( regulations "u subsection 7f77#a71 & annually !reaft]1 ! ,adm9i/rator %all submit to ,congress a report t describes ! claims submitt$ "u ?is ,act dur+ ! ye> prec$+ ! date ( submission ( ! report1 includ+1 = ea* claim-- 7#a7 ! am\nt claim$2 7#b7 a brief description ( ! nature ( ! claim2 & 7#c7 ! /atus or disposition ( ! claim1 includ+ ! am\nt ( any paym5t "u ?is ,act4 7o7 ,au?orization ( appropriations ,!re are au?oriz$ to be appropriat$ su* sums z are necess>y to c>ry out ?is ,act4 ,secret>y