,,ii #aah? ,,congress #b;d ,session ,s4 #ddbf ,,9 ,,! ,,s5ate ,,( ,,! ,,unit$ ,,/ates ,may #bc1 #bjbd,mr4 ,braun 7= himself1 ,mrs4 ,gillibr&1 ,mr4 ,cram]1 ,mr4 ,man*91 ,mr4 ,s*mitt1 ,mr4 ,padilla1 ,mr4 ,vance1 ,mr4 ,book]1 ,mr4 ,hawley1 ,mr4 ,wel*1 & ,ms4 ,murk[ski7 introduc$ ! foll[+ bill2 :i* 0 read twice & ref]r$ to ! ,committee on ,heal?1 ,education1 ,labor1 & ,p5sions ,a ,,bill ,to am5d ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act to e/abli% a "t-limit$ conditional approval pa?way1 subject to specific obligations1 = c]ta9 drugs & biological products1 & = o!r purposes4 #a4 ,%ort title ,?is ,act may be cit$ z ! ,promis+ ,pa?way ,act #b4j4 #b4 ,conditional approval ( new human drugs = individuals ) r>e1 progressive1 & s]i\s diseases 7a7 ,9 g5]al ,sub*apt] ,a ( *apt] ,v ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cea et seq47 is am5d$ by add+ at ! end ( ! foll[+3 #ebd;,c4 ,conditional approval ( human drugs = individuals ) r>e1 progressive1 & s]i\s diseases 7a7 ,conditional approval2 priority review2 o!r designations 7#a7 ,9 g5]al ,! sponsor ( a drug may file ) ! ,secret>y an application = conditional approval ( an eligible drug describ$ 9 subsection 7b74 ,! ,secret>y %all approve or d5y su* application 9 accordance ) subsection 7c74 7#b7 ,priority review ,! ,secret>y %all give priority review to an application = conditional approval ( an eligible drug describ$ 9 subsection 7b74 7#c7 ,o!r designations ,if a drug t is grant$ conditional approval "u ?is section is eligible = a special designation by ! ,secret>y "u ?is ,act1 includ+ z a drug = a r>e disease or condition "u section #ebf1 all applicable b5efits ( su* o!r designation %all be available = use "u su* conditional approval1 includ+ any tax cr$its & waiv+ ( fees "u *apt] ,,vii4 7#d7 ,o!r programs ,a sponsor ( a drug seek+ conditional approval ( su* drug "u ?is section may also seek designation1 exclusivity1 or approval1 z applicable1 ( su* drug "u o!r applicable provisions ( ?is ,act or ! ,public ,heal? ,s]vice ,act1 subject to ! requirem5ts ( su* provisions4 7b7 ,eligibility 7#a7 ,9 g5]al ,a drug may be eligible = conditional approval "u ?is section if su* drug is int5d$ to treat a disease or condition t is-- 7,a7 rapidly progressive1 t]m9al1 & has sub/antial unmet m$ical ne$1 z det]m9$ by ! ,secret>y2 or 7,b7 a r>e disease or condition 7z def9$ 9 section #ebf7;a77#b77 t results 9 a sub/antially %ort5$ lifespan1 sub/antial r$uction 9 quality ( life1 or o!r sub/antial adv]se heal? effects1 z det]m9$ by ! ,secret>y4 7#b7 ,exclusion f eligibility ,a drug t is int5d$ to treat or respond to a mat]ial ?reat id5tifi$ by ! ,secret>y ( ,homel& ,security "u section #cai;,f-#b7;c77#b77;,a77ii7 %all n be eligible = conditional approval "u ?is section4 7c7 ,/&>d ( review = conditional approval 7#a7 ,requirem5ts ,! ,secret>y %all only approve an application = conditional approval ( a drug "u ?is section if-- 7,a7 ! ,secret>y det]m9es t-- 7i7 7,i7 evid5ce ( safety = ! drug has be5 e/abli%$ by-- 7aa7 ! completion ( a phase #a cl9ical inve/igation ( ! drug 7z describ$ 9 section #cab4ba ( title #ba1 ,code ( ,f$]al ,regulations 7or successor regulations772 or 7bb7 ano!r demon/ration ( safety1 z det]m9$ appropriate by ! ,secret>y2 & 7,,ii7 evid5ce ( effectiv5ess 9 treat+ a giv5 indication 7:i* indication is congru5t ) ! eligibility requirem5ts ( subsection 7b771 z e/abli%$ by an ongo+ or complet$ phase #b cl9ical inve/igation ( ! drug 7z describ$ 9 section #cab4ba ( title #ba1 ,code ( ,f$]al ,regulations 7or successor regulations772 or 7ii7 9 ! case ( a drug t is int5d$ to treat a t]m9al p$iatric r>e disease or condition 7z def9$ 9 section #ebf7;a77#b77 t does n pr$om9ately affect adults-- 7,i7 evid5ce ( safety = ! drug has be5 e/abli%$ 9 accordance ) clause 7i77,i72 & 7,,ii7 ! drug %[s prelim9>y evid5ce ( cl9ical effectiv5ess bas$ ^u /udies 9 animal models2 & 7,b7 ! sponsor has provid$ a writt5 affirmation ( ! sponsor's int5t to pursue "u section #eje ( ?is ,act or section #cea ( ! ,public ,heal? ,s]vice ,act approval ( ! drug1 :i* affirmation %all include a ju/ification & a plan = pursu+ su* approval4 7#b7 ,roll+1 real-"t review 7,a7 ,9 g5]al ,if ! ,secret>y det]m9es1 aft] prelim9>y evaluation ( data submitt$ by ! sponsor1 t a drug may meet ! /&>d = conditional approval1 ! sponsor may submit portions ( an application = conditional approval ( a drug "u ?is section = evaluation by ! ,secret>y be=e ! sponsor submits a complete application1 :i* submission %all include-- 7i7 a s*$ule = submission ( in=mation necess>y to make ! application complete2 & 7ii7 a paym5t ( any fee t may be requir$ "u section #gcf4 7,b7 ,review ,! ,secret>y-- 7i7 %all evaluate ea* application submitt$ "u subp>agraph 7,a7 to assess :e!r su* application is complete or ready to be fil$2 & 7ii7 may comm5ce review ( portions ( su* application = approval4 7#c7 ,use ( real-_w evid5ce 7,a7 ,9 g5]al ,! ,secret>y %all all[ ! use ( real _w evid5ce 7z def9$ 9 section #eje;,f7b771 includ+ real _w data us$ to g5]ate real _w evid5ce1 & ( ext]nal s\rces ( data1 includ+ prospective or retrospective natural hi/ory data1 to support an application = conditional approval "u ?is section4 7,b7 ,data integrity requirem5ts ,9 us+ evid5ce describ$ 9 subp>agraph 7,a7 to support an application = conditional approval "u ?is section1 ! sponsor %all consid] ! guidance ( ! ,food & ,drug ,adm9i/ration entitl$ ,data ,/&>ds = ,drug & ,biological ,product ,submissions ,conta9+ ,real-,_w ,data & dat$ ,decemb] #bjbc 7or successor guidance74 7d7 ,,fda au?ority ,to )draw conditional approval 7#a7 ,9 g5]al ,! ,secret>y may )draw ! conditional approval ( a drug "u ?is section if-- 7,a7 aft] adequate review ( appropriate safety data1 includ+ data f an obs]vational regi/ry e/abli%$ "u subsection 7g71 ! ,secret>y det]m9es t su* data no long] supports conditional approval2 7,b7 ! ,secret>y det]m9es t ! application = conditional approval submitt$ "u subsection 7a77#a7 conta9$ an untrue /atem5t ( mat]ial fact2 or 7,c7 ! ,secret>y det]m9es t ! drug is no long] eligible "u subsection 7b74 7#b7 ,,fda exam9ation au?ority 7,a7 ,9 g5]al ,= purposes det]m9+ :e!r to )draw ! conditional approval ( a drug "u p>agraph 7#a71 ! ,secret>y may-- 7i7 review any available cl9ical data made available ?r\gh cl9ical trials or an obs]vational regi/ry "u subsection 7g71 applicable to su* drug2 & 7ii7 det]m9e :e!r ! sponsor ( su* drug is 9 violation ( a requirem5t e/abli%$ "u p>agraph 7#c7 or 7#d7 ( section #eje7o7 or section #eje-a ) respect to ! drug4 7,b7 ,transp>5cy 7i7 ,9 g5]al ,! ,secret>y may require drug sponsors & obs]vational regi/ries "u subsection 7g7 to submit ! data describ$ 9 subp>agraph 7,a7 = ! purposes ( ! review "u t subp>agraph4 7ii7 ,f9es ,! ,secret>y may levy f9es on sponsors & obs]vational regi/ries t d n comply ) a reque/ = data "u clause 7i7 )9 su* reasonable timeframe z is e/abli%$ by ! ,secret>y4 7#c7 ,effect ( )drawal 7,a7 ,availability to new pati5ts 7i7 ,9 g5]al ,if a conditional approval is )drawn "u ?is subsection1 ! sponsor may n make ! drug available to any new pati5ts1 b may cont9ue to make su* drug available to pati5ts :o />t$ tak+ ! drug prior to ! date ( )drawal4 7ii7 ,effect ,no?+ 9 ?is subp>agraph %all be con/ru$ to require-- 7,i7 a pati5t to cont9ue tak+ a conditionally approv$ drug if su* pati5t decides to /op tak+ su* drug2 or 7,,ii7 ! sponsor to ensure su* drug cont9ues to be manufactur$ aft] ! date ( )drawal4 7,b7 ,civil monet>y p5alty ,any sponsor :o makes available to new pati5ts a drug = :i* conditional approval has be5 )drawn "u ?is subsection %all be subject to su* civil monet>y p5alty z is det]m9$ by ! ,secret>y4 7#d7 ,)drawal notice ,^u det]m9+ to )draw ! conditional approval ( a drug "u p>agraph 7#a71 ! ,secret>y %all submit writt5 notice to ! sponsor ( su* drug & su* )drawal %all be effective on ! date t is #ad days aft] ! date ( su* submission ( notice4 7#e7 ,appeals ,n lat] ?an #ahj days aft] ! date ( enactm5t ( ! ,promis+ ,pa?way ,act #b4j1 ! ,secret>y1 by rule1 %all e/abli% a process by :i* a sponsor ( a drug = :i* conditional approval 0 )drawn "u p>agraph 7#a7 may appeal su* )drawal4 7#f7 ,automatic )drawal 7,a7 ,9 g5]al ,if ! sponsor ( a drug t receives conditional approval "u ?is section does n submit an application = r5ewal ( su* conditional approval "u subsection 7f77#b7 by ! deadl9e "u t subsection1 su* conditional approval %all automatically be )drawn 9 accordance ) p>agraph 7#c7 on ! date on :i* su* conditional approval expires4 7,b7 ,m>ket+ requirem5t ,if any drug t receives conditional approval "u ?is section is n br\ght to m>ket )9 #a ye> ( ! date on :i* ! conditional approval is grant$1 su* conditional approval1 along ) any b5efits describ$ 9 subsection 7a77#c71 %all automatically be )drawn 9 accordance ) p>agraph 7#c7 on su* date4 7,c7 ,no "r to appeal2 effect ( automatic )drawal 7i7 ,9 g5]al ,a sponsor %all n h ! "r to appeal an automatic )drawal "u ?is p>agraph4 7ii7 ,effect ,! ,secret>y %all h no means or p[] to prev5t an automatic )drawal "u ?is p>agraph f occurr+4 7e7 ,label+2 review ( mat]ials 7#a7 ,9 g5]al ,sponsors may n make available to pati5ts a drug conditionally approv$ "u ?is section1 unless-- 7,a7 all label+ & adv]tis+ ( su* drug conta9s ! /atem5t conditionally approv$ = a limit$ population 9 a prom95t mann] & adjac5t to1 & n m prom95t ?an-- 7i7 ! propriet>y "n ( su* drug1 if any2 or 7ii7 if !re is no propriet>y "n1 ! e/abli%$ "n ( su* drug1 if any1 z def9$ 9 section #ejb7;e77#c71 or1 9 ! case ( a drug t is a biological product1 ! prop] "n1 z def9$ by regulation2 & 7,b7 ! prescrib+ in=mation = ! drug requir$ by section #bja4eg ( title #ba1 ,code ( ,f$]al ,regulations 7or any successor regulation7 includes ! foll[+ /atem5t3 ,?is drug is conditionally approv$ = use 9 a limit$ & specific population4 ,?is drug has n receiv$ full approval by ! ,food & ,drug ,adm9i/ration4 ,conditional approval ( ?is drug may be )drawn at %ort notice44 7#b7 ,submission ,n lat] ?an #de days be=e su* mat]ials are di/ribut$1 all promotional1 educational1 & m>ket+ mat]ials = su* drug %all be submitt$ to ! ,secret>y = review4 7#c7 ,public li/ ,! ,secret>y %all ma9ta9 a li/ ( all drugs conditionally approv$ "u ?is section on a publicly accessible website4 ,su* website %all briefly describe :at ea* conditionally approv$ drugs is & li/ ! #a or m diseases or conditions = :i* ! drug is indicat$4 7f7 ,r5ewal ( conditional approval2 requirem5t ,to br+ drug to m>ket 7#a7 ,duration2 r5ewals ,! conditional approval = a drug "u ?is section is effective = a #b-ye> p]iod4 ,! sponsor may reque/ r5ewal ( su* conditional approval = up to #c subsequ5t #b-ye> p]iods4 ,conditional approval ) respect to a drug %all n exce$ a total ( #h ye>s f ! initial date ! drug 0 grant$ conditional approval4 7#b7 ,applications = r5ewal ( conditional approval 7,a7 ,9 g5]al ,except z provid$ 9 subp>agraph 7,c71 ! sponsor ( a drug seek+ a r5ewal ( conditional approval = su* drug "u ?is subsection %all submit to ! ,secret>y1 n lat] ?an #ahj days be=e ! date on :i* su* conditional approval expires1 an application t conta9s ! applicable in=mation describ$ 9 p>agraph 7#c7 9 a /&>diz$ =mat det]m9$ by ! ,secret>y4 7,b7 ,process = grant+ r5ewals ,n lat] ?an #ahj days aft] ! date ( enactm5t ( ! ,promis+ ,pa?way ,act #b4j1 ! ,secret>y1 by rule1 %all e/abli% ! process = grant+ a r5ewal "u ?is subsection4 7,c7 ,exemption = small population diseases 7i7 ,9 g5]al ,! ,secret>y %all exempt f ! requirem5ts ( subp>agraph 7,a7 & p>agraph 7#c7 an application = a r5ewal ( conditional approval = a drug "u ?is subsection if ! ,secret>y det]m9es t ! population affect$ by ! disease or condition t ! drug is int5d$ to treat does n support additional prelim9>y evid5ce ( effectiv5ess 7z def9$ 9 p>agraph 7#c77;,d774 7ii7 ,application = exemption ,sponsors may submit an application = exemption "u ?is subp>agraph n lat] ?an #ahj days be=e ! date on :i* ! conditional approval expires4 7iii7 ,application process ,n lat] ?an #ahj days aft] ! date ( enactm5t ( ! ,promis+ ,pa?way ,act #b4j1 ! ,secret>y %all e/abli% a /&>diz$ application process = purposes ( ?is subp>agraph4 7iv7 ,deadl9e ,! ,secret>y %all approve or d5y an application "u ?is subp>agraph be=e ! date on :i* ! conditional approval expires4 7v7 ,appeals ,n lat] ?an #ahj days aft] ! date ( enactm5t ( ! ,promis+ ,pa?way ,act #b4j1 ! ,secret>y %all e/abli% a process "u :i* a sponsor my appeal a d5ial ( an application "u ?is subp>agraph4 7#c7 ,additional prelim9>y evid5ce ( effectiv5ess ,! in=mation describ$ 9 ?is p>agraph is ! foll[+3 7,a7 ,= ! fir/ approval r5ewal ,) respect to an application "u p>agraph 7#b7 = ! fir/ r5ewal ( conditional approval = a drug "u ?is subsection1 additional prelim9>y evid5ce ( effectiv5ess ( ! drug1 z comp>$ to ! evid5ce provid$ 9 ! initial application = conditional approval = ! drug "u subsection 7c74 7,b7 ,= ! second approval r5ewal ,) respect to an application "u p>agraph 7#b7 = ! second r5ewal ( conditional approval = a drug "u ?is subsection1 additional prelim9>y evid5ce ( effectiv5ess ( ! drug1 z comp>$ to ! evid5ce provid$ 9 ! r5ewal application describ$ 9 subp>agraph 7,a74 7,c7 ,= ! f9al approval r5ewal ,) respect to an application "u p>agraph 7#b7 = ! ?ird r5ewal ( conditional approval = a drug "u ?is subsection1 a writt5 affirmation f ! head ( ! drug's review division ( ! ,(fice ( ,new ,drugs or ! ,(fice ( ,!rapeutic ,products ass]t+ t a ?ird r5ewal is necess>y-- 7i7 = pati5ts :o h b5efitt$ f su* drug to reta9 access to su* drug2 & 7ii7 to g5]ate additional prelim9>y evid5ce ( effectiv5ess = ! purposes ( atta9+ approval "u section #eje ( ?is ,act or section #cea ( ! ,public ,heal? ,s]vice ,act4 7,d7 ,def9ition ,9 ?is p>agraph1 ! t]m prelim9>y evid5ce ( effectiv5ess means-- 7i7 cl9ical evid5ce g5]at$ by an ongo+ or complet$ cl9ical trial conduct$ 9 accordance ) section #aa4bb ( title #db1 ,code ( ,f$]al ,regulations 7or successor regulations72 7ii7 real-_w evid5ce 7z def9$ 9 section #eje;,f7b772 or 7iii7 evid5ce f an obs]vational regi/ry "u subsection 7g74 7#d7 ,d5ial ( r5ewal on ! basis ( data fraud ,! ,secret>y may d5y ! application = r5ewal ( conditional approval = a drug "u ?is subsection if ! ,secret>y1 9 conduct+ a review "u subsection 7d77#b71 f9ds t ! evid5ce provid$ 9 su* application "u subp>agraph 7,a7 or 7,b7 ( p>agraph 7#c7 0 fraudul5tly manipulat$ by ! applicable obs]vational regi/ry & t su* application sub/antially relies on su* data4 7g7 ,obs]vational regi/ries 7#a7 ,e/abli%m5t 7,a7 ,9 g5]al ,subject to subp>agraph 7,c71 ! sponsor ( a drug conditionally approv$ "u ?is section %all e/abli% an obs]vational regi/ry1 = pati5ts :o are or w be treat$ ) su* drug1 t p]ta9s to ! disease or condition t ! drug is int5d$ to treat4 7,b7 ,regi/ries ,9 e/abli%+ an obs]vational regi/ry = a drug "u subp>agraph 7,a71 ! sponsor may-- 7i7 e/abli% a new obs]vational regi/ry2 7ii7 use an exi/+ obs]vational regi/ry t p]ta9s to ! disease or condition su* drug is int5d$ to treat2 7iii7 comb9e #a or m exi/+ obs]vational regi/ries t p]ta9 to ! disease or condition su* drug is int5d$ to treat ) a new obs]vational regi/ry2 or 7iv7 comb9e #b or m exi/+ obs]vational regi/ries t p]ta9 to ! disease or condition su* drug is int5d$ to treat4 7,c7 ,approval ( regi/ry & "r to appeal ,n lat] ?an #ahj days aft] ! date ( enactm5t ( ! ,promis+ ,pa?way ,act #b4j1 ! ,secret>y %all e/abli%-- 7i7 a process to approve or d5y ! e/abli%m5t ( an obs]vational regi/ry "u subp>agraph 7,a72 & 7ii7 a process = sponsors t receiv$ su* a d5ial to appeal ! d5ial4 7#b7 ,requirem5t = pati5ts to enroll 9 obs]vational regi/ry 7,a7 ,9 g5]al ,a drug conditionally approv$ "u ?is section %all n be made available to a pati5t unless su* pati5t is enroll$ 9 ! applicable obs]vational regi/ry describ$ 9 p>agraph 7#a74 7,b7 ,in=m$ cons5t 7i7 ,9 g5]al ,prior to enroll+ 9 an obs]vational regi/ry "u subp>agraph 7,a71 a pati5t %all provide in=m$ cons5t 9 accordance ) clause 7ii74 7ii7 ,application ( c]ta9 requirem5ts ,! requirem5ts = in=m$ cons5t "u "p #ej ( sub*apt] ,a ( *apt] ,i ( title #ba1 ,code ( ,f$]al ,regulations 7or successor regulations71 %all apply to enrollm5t an obs]vational regi/ry "u ?is p>agraph4 7#c7 ,submission ( pati5t data 7,a7 ,9 g5]al ,! sponsor ( a drug conditionally approv$ "u ?is section %all be responsible = obta9+ & submitt+ pati5t data to ! applicable obs]vational regi/ry describ$ 9 p>agraph 7#a74 7,b7 ,submission /&>ds ,n lat] ?an #ahj days aft] date ( enactm5t ( ! ,promis+ ,pa?way ,act #b4j1 ! ,secret>y %all e/abli% data submission /&>ds = sponsors to comply ) = purposes ( subp>agraph 7,a7 to ensure t regi/ry data is consi/5t & cl9ically in=m$4 7#d7 ,requirem5ts = regi/ries ,an obs]vational regi/ry describ$ 9 p>agraph 7#a7 = a drug conditionally approv$ "u ?is section may be op]at$ by ! sponsor ( su* drug or1 at ! sponsor's discretion1 a ?ird p>ty1 =-pr(it organization1 or nonpr(it organization4 7#e7 ,risk & b5efit data 7,a7 ,9 g5]al ,! sponsor ( a drug conditionally approv$ "u ?is section %all submit relevant risk & b5efit data to ! applicable obs]vational regi/ry describ$ 9 p>agraph 7#a74 7,b7 ,onl9e portal ,! ,secret>y %all op]ate an onl9e portal on an exi/+ website ( ! ,secret>y = sponsors to submit data describ$ 9 subp>agraph 7,a74 7#f7 ,accessibility 7,a7 ,9 g5]al ,an obs]vational regi/ry describ$ 9 p>agraph 7#a7 %all-- 7i7 n lat] ?an #cj days aft] receipt ( a reque/1 provide pati5ts 7or _! designat$ repres5tatives7 ) access to su* pati5t's p]sonal regi/ry in=mation2 & 7ii7 provide approv$ rese>*]s & m$ical pr(essionals access to de-id5tifi$ & aggregat$ data f ! regi/ry = ! purposes ( indication- & disease-specific & translational rese>* into conditions & diseases relat+ to ! disease or condition t ! drug track$ by ! obs]vational regi/ry is int5d$ to treat4 7,b7 ,approv$ rese>*]s & m$ical pr(essionals ,n lat] ?an #ahj days aft] ! date ( enactm5t ( ! ,promis+ ,pa?way ,act #b4j1 ! ,secret>y1 by rule1 %all e/abli% a process = approv+ rese>*]s & m$ical pr(essionals = purposes ( subp>agraph 7,a77ii74 7#g7 ,effect ,no?+ 9 ?is section %all be con/ru$ to modify or limit ! ,secret>y's au?ority to require = a drug conditionally approv$ "u ?is section any type ( po/approval /udy "u any o!r provision ( law1 includ+ sections #eje7o77#c71 #eje;,b1 & #ejf4 7h7 ,pursuit ( a diff]5t indication 7#a7 ,9 g5]al ,9 ! case ( a drug conditionally approv$ "u ?is section = :i* su* approval 0 )drawn "u subsection 7d71 expir$ "u subsection 7f77#a71 or 0 d5i$ = r5ewal "u subsection 7f77#d71 n lat] ?an #b ye>s aft] ! date ( )drawal1 expiration1 or d5ial1 z applicable1 ! sponsor ( su* drug %all h ! opportunity to petition ! ,secret>y to receive conditional approval ( su* drug1 9 accordance ) ?is section1 = a diff]5t indication4 7#b7 ,process ,n lat] ?an #ahj days aft] ! date ( enactm5t ( ! ,promis+ ,pa?way ,act #b4j1 ! ,secret>y %all e/abli% a process = petitions "u p>agraph 7#a74 7i7 ,transition to o!r =ms ( approval 7#a7 ,9 g5]al ,a drug t receives conditional approval "u ?is section may be grant$ approval "u section #eje ( ?is ,act or section #cea ( ! ,public ,heal? ,s]vice ,act dur+ ! p]iod 9 :i* su* conditional approval is 9 effect4 ,effective on ! date on :i* approval = su* drug is grant$ "u section #eje ( ?is ,act or section #cea ( ! ,public ,heal? ,s]vice ,act1 su* conditional approval %all be automatically )drawn 9 accordance ) subsection 7d77#c74 7#b7 ,consid]ation ( c]ta9 evid5ce ,9 det]m9+ :e!r to approve "u section #eje ( ?is ,act or section #cea ( ! ,public ,heal? ,s]vice ,act a drug t has receiv$ conditional approval "u ?is section1 ! ,secret>y may consid] evid5ce f ! obs]vational regi/ry = ! drug "u subsection 7g74 7j7 ,in=m$ cons5t 7#a7 ,9 g5]al ,prior to be+ prescrib$ a drug conditionally approv$ "u ?is section1 a pati5t %all provide in=m$ cons5t 9 accordance ) p>agraph 7#b74 7#b7 ,application ( c]ta9 requirem5ts ,! requirem5ts = in=m$ cons5t "u "p #ej ( sub*apt] ,a ( *apt] ,i ( title #ba1 ,code ( ,f$]al ,regulations 7or successor regulations71 %all apply to drugs conditionally approv$ "u ?is section4 7#c7 ,obs]vational regi/ries ,an obs]vational regi/ry e/abli%$ = a drug 9 accordance ) subsection 7g7 may obta91 & ma9ta9 records (1 in=m$ cons5t ( a pati5t on behalf ( ! drug sponsor1 9 accordance ) p>agraph 7#b74 7#d7 ,common rule ,drugs conditionally approv$ "u ?is section %all comply ) subp>t ,a ( "p #df ( title #de1 ,code ( ,f$]al ,regulations 7commonly kn[n z ! ,common ,rule7 7or successor regulations71 if applicable4 7k7 ,limitation on liability ,) respect to any claim "u ,/ate law relat+ to a drug made available pursuant to a grant ( conditional approval "u ?is section1 no liability %all lie aga9/ a sponsor or manufactur] ( ! drug1 or any heal? c>e provid] :o prescribes or adm9i/]s ! drug1 abs5t int5tional wrongdo+4 7l7 ,report to ,congress 7#a7 ,9 g5]al ,n lat] ?an #b ye>s aft] ! date ( enactm5t ( ! ,promis+ ,pa?way ,act #b4j1 & once e #b ye>s !reaft]1 ! ,secret>y1 9 collaboration ) drug sponsors1 %all submit a report to ,congress on all drugs grant$ conditional approval "u ?is section4 ,su* report %all include-- 7,a7 an e/imat$ numb] ( pati5ts treat$ ) ea* su* drug1 & ! numb] ( pati5ts track$ 9 an obs]vational regi/ry "u subsection 7g7 ) respect to ea* su* drug1 if applicable2 7,b7 a discussion1 at an aggregate level 1 ( ! types & am\nts ( data obta9$ ?r\gh obs]vational regi/ries "u subsection 7g71 su* z pati5t treatm5ts & uses1 l5g? ( use1 side effects enc\nt]$1 relevant biom>k]s1 scan results1 cause ( dea? & h[ long ! pati5t liv$1 & adv]se drug effects2 7,c7 a li/ ( all su* drugs = :i* an application = approval "u ?is section1 or an application = an ext5sion ( conditional approval "u ?is section1 has be5 submitt$2 & 7,d7 ! numb] ( all applications grant$ & d5i$ conditional approval "u ?is section4 7#b7 ,sponsor p>ticipation ,n lat] ?an #ahj days be=e ! date on :i* ! ,secret>y submits a report "u p>agraph 7#a71 ! sponsor ( a drug conditionally approv$ "u ?is section %all provide to ! ,secret>y ! in=mation describ$ 9 subp>agraphs 7,a7 & 7,b7 ( p>agraph 7#a71 z applicable4 7#c7 ,notice au?ority ,! ,secret>y may notify sponsors ( drugs conditionally approv$ "u ?is section & obs]vational regi/ries "u subsection 7g7 z necess>y to complete a report "u p>agraph 7#a74 4 7b7 ,con=m+ am5dm5t ,section #eje7;a7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cee7;a77 is am5d$ by ins]t+ 1 or !re is 9 effect a conditional approval "u section #ebd;,c ) respect to su* drug be=e ! p]iod4 7c7 ,reimbursem5t 7#a7 ,private heal? insur]s ,section #bgai;,a ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #cjj;gg-#ai;a7 is am5d$ by add+ at ! end ! foll[+3 7f7 ,cov]age ( c]ta9 drugs ,a gr\p heal? plan or heal? insurance issu] (f]+ gr\p or individual heal? insurance cov]age %all provide cov]age =1 & %all n impose any co/ %>+ requirem5ts =1 drugs conditionally approv$ "u section #ebd;,c ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act = pati5ts :o h ! disease or condition ! drug is int5d$ to treat4 4 7#b7 ,f$]al heal? c>e programs ,! requirem5t "u subsection 7f7 ( section #bgai;,a ( ! ,public ,heal? ,s]vice ,act 7z add$ by p>agraph 7#a77 %all apply ) respect to cov]age det]m9ations "u a ,f$]al heal? c>e program 7z def9$ 9 section #aabh;,b7f7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acbj;a-#g;b7f777 9 ! same mann] su* requirem5t applies "u su* subsection 7f74 7#c7 ,con=m+ am5dm5t ,section #aibg7k77#b77;,a77i7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acifr-#h7k77#b77;,a77i77 is am5d$-- 7,a7 by /rik+ or :i* & ins]t+ 1 :i*2 & 7,b7 by ins]t+ 1 or :i* is conditionally approv$ "u section #ebd;,c ( su* ,act be=e ! semicolon4