,i #aad? ,,congress #a/ ,session ,h4 ,r4 #ajff ,,9 ,,! ,,h\se ,,( ,,repres5tatives ,febru>y #be1 #bjae ,mr4 ,coll9s ( ,new ,york 7= himself & ,mr4 ,pompeo7 introduc$ ! foll[+ bill2 :i* 0 ref]r$ to ! ,committee on ,en]gy & ,comm]ce ,a ,,bill ,to am5d ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act to promote ! use ( adaptive trial designs1 ,bayesian me?ods1 & o!r innovative /ati/ical me?ods 9 cl9ical protocols = drugs1 biological products1 & devices1 & ) respect to ! requirem5t to conduct po/approval /udies & cl9ical trials1 & = o!r purposes4 #a4 ,%ort title ,?is ,act may be cit$ z ! ,cl9ical ,trials ,mod]nization ,act ( #bjae4 #b4 ,cl9ical trial mod]nization 7a7 ,proposals = use ( innovative /ati/ical me?ods 9 cl9ical protocols = drugs1 biological products1 & devices ,*apt] ,v ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act is am5d$ by ins]t+ aft] section #ejf;,f 7#ba ,u4,s4,c4 #cef;f7 ! foll[+ new section3 #ejg4 ,cl9ical trial mod]nization 7a7 ,9 g5]al ,to promote ! effici5cy ( ! developm5t & regulatory review & approval1 lic5sure1 or cle>ance ( drugs1 biological products1 & devices & ! timely availability ( innovative treatm5ts1 ! ,secret>y %all1 aft] provid+ notice & an opportunity = public comm5t1 e/abli% & implem5t a framework ?r\gh :i*-- 7#a7 sponsors ( drugs1 biological products1 or devices may submit to ! ,secret>y a proposal = ! incorporation ( adaptive trial designs1 ,bayesian me?ods1 or o!r alt]native /ati/ical me?ods into propos$ cl9ical protocols & m>ket+ applications = drugs1 biological products1 or devices2 & 7#b7 ! ,secret>y w commit to timel9es = review+ & provid+ fe$back on proposals s submitt$4 4 7b7 ,guidance address+ use ( adaptive trial designs & ,bayesian me?ods 7#a7 ,9 g5]al ,! ,secret>y ( ,heal? & ,human ,s]vices1 act+ ?r\gh ! ,commission] ( ,food & ,drugs 79 ?is subsection ref]r$ to z ! ,secret>y71 %all-- 7,a7 update & f9alize ! draft guidance address+ ! use ( adaptive trial design = drugs & biological products2 & 7,b7 issue draft guidance on ! use ( ,bayesian me?ods 9 ! developm5t & regulatory review & approval1 lic5sure1 or cle>ance ( drugs1 biological products1 & devices4 7#b7 ,cont5ts ,! guidances "u p>agraph 7#a7 %all-- 7,a7 e/abli% or cl>ify /&>ds = us+ adaptive trial designs & ,bayesian me?ods 9 cl9ical trials1 includ+ cl9ical trials t =m ! prim>y basis = approval1 cle>ance1 or lic5sure ( ! products involv$ 7su* z trials t provide sub/antial evid5ce = ! approval ( drugs72 7,b7 e/abli% a me*anism = sponsors to obta9 fe$back f ! ,secret>y "u section #ejg1 z add$ by subsection 7a71 on te*nical issues relat$ to model+ & simulations prior to-- 7i7 completion ( su* model+ or simulations2 or 7ii7 ! submission ( result+ in=mation to ! ,secret>y2 7,c7 specify ! types ( quantitative & qualitative in=mation requir$ = review2 & 7,d7 specify ! recomm5d$ analysis me?odology4 7#c7 ,public meet+ ,prior to updat+ or develop+ ! guidances requir$ by p>agraph 7#a71 ! ,secret>y %all consult1 ?r\gh a public meet+ to be held no lat] ?an #a ye> aft] ! date ( enactm5t ( ?is ,act1 ) /akehold]s includ+ repres5tatives ( regulat$ indu/ry1 academia1 pati5t advocacy organizations1 & disease rese>* f\ndations4 7#d7 ,s*$ule ,! ,secret>y %all1 aft] provid+ notice & opportunity = public comm5t1 publi%-- 7,a7 ! f9al guidance requir$ by p>agraph 7#a77;,a7 n lat] ?an #f mon?s aft] ! date ( ! public meet+ requir$ by p>agraph 7#c72 & 7,b7 ! guidance requir$ by p>agraph 7#a77;,b7 n lat] ?an #ab mon?s aft] ! date ( ! public meet+ requir$ by p>agraph 7#c74 7#e7 ,review & revision ( guidance docum5ts ,n lat] ?an #dh mon?s aft] ! date ( enactm5t ( ?is ,act1 ! ,secret>y %all review &1 z appropriate1 revise ! guidance docum5ts requir$ by subp>agraphs 7,a7 & 7,b7 ( p>agraph 7#a7 to reflect developm5ts 9 /ati/ical me?ods t c\ld be appropriate = use 9 cl9ical trials1 includ+ cl9ical trials t-- 7,a7 =m ! prim>y basis = approval1 cle>ance1 or lic5sure ( drugs1 biological products or devices2 or 7,b7 provide sub/antial evid5ce = ! approval ( drugs4 #c4 ,evaluations ( requir$ po/approval /udies & cl9ical trials 7a7 ,9 g5]al ,section #eje7o77#c7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cee7o77#c77 is am5d$ by add+ at ! end ! foll[+ new subp>agraph3 7,g7 ,evaluations ( requir$ po/approval /udies & cl9ical trials 7i7 ,9 g5]al ,! ,secret>y %all e/abli% a process "u :i* ! ,secret>y1 on ! initiative ( ! ,secret>y or at ! reque/ ( a responsible p]son1 %all p]iodically evaluate a po/approval /udy or cl9ical trial requir$ to be conduct$ "u ?is p>agraph to det]m9e :e!r-- 7,i7 ! trial or /udy is no long] sci5tifically w>rant$2 or 7,,ii7 ! design1 or ! timel9es applicable to ! completion (1 ! /udy or trial %\ld be r5egotiat$ because ( *anges 9 m$ical practice or ! /&>d ( c>e4 7ii7 ,n sci5tifically w>rant$ ,9 ! case ( a det]m9ation "u clause 7i77,i7 t a po/approval /udy or cl9ical trial requir$ to be conduct$ "u ?is p>agraph is no long] sci5tifically w>rant$1 ! ,secret>y %all no long] require ! responsible p]son to conduct ! /udy or trial4 7iii7 ,r5egotiation ,9 ! case ( a det]m9ation "u clause 7i77,,ii7 t ! design1 or ! timel9es applicable to ! completion (1 a po/approval /udy or cl9ical trial requir$ to be conduct$ "u ?is p>agraph %\ld be r5egotiat$1 ! ,secret>y %all ent] into negotiations ) ! responsible p]son to make su* *anges z may be necess>y to su* design or timel9es z ! ,secret>y det]m9es are necess>y4 4 7b7 ,guidance ,n lat] ?an "o ye> aft] ! date ( ! enactm5t ( ?is ,act1 ! ,secret>y %all issue draft guidance on ! implem5tation ( subp>agraph 7,g7 ( section #eje7o77#c7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cee7o77#c771 z add$ by subsection 7a74 ,n lat] ?an two ye>s aft] su* date ( enactm5t1 ! ,secret>y %all issue f9al guidance on su* implem5tation4