,,ib ,union ,cal5d> ,no4 #dac #aaf? ,,congress #b;d ,session ,h4 ,r4 #dhff ,report ,no4 #aaf-eac ,,9 ,,! ,,h\se ,,( ,,repres5tatives ,octob] #bh1 #bjai,mr4 ,pallone 7= himself & ,mr4 ,gu?rie7 introduc$ ! foll[+ bill2 :i* 0 ref]r$ to ! ,committee on ,en]gy & ,comm]ce ,septemb] #ag1 #bjbj;,additional sponsor3 ,ms4 ,spanb]g] ,septemb] #ag1 #bjbj,report$ ) an am5dm5t2 committ$ to ! ,committee ( ! ,:ole ,h\se on ! ,/ate ( ! ,union & ord]$ to be printed,strike out all aft] ! enact+ clause & ins]t ! "p pr9t$ 9 italic,for text ( introduc$ bill1 see copy ( bill z introduc$ on ,octob] #bh1 #bjai ,a ,,bill ,to am5d ! #ba/ ,c5tury ,cures ,act to provide = designation ( in/itutions ( high] education t provide rese>*1 data1 & lead]%ip on cont9u\s manufactur+ z ,national ,c5t]s ( ,excell5ce 9 ,cont9u\s ,ph>maceutical ,manufactur+1 & = o!r purposes4 #a4 ,%ort title ,?is ,act may be cit$ z ! ,national ,c5t]s ( ,excell5ce 9 ,cont9u\s ,ph>maceutical ,manufactur+ ,act ( #bjbj4 #b4 ,national ,c5t]s ( ,excell5ce 9 ,cont9u\s ,ph>maceutical ,manufactur+ 7a7 ,9 g5]al ,section #cjaf ( ! #ba/ ,c5tury ,cures ,act 7#ba ,u4,s4,c4 #cii;h7 is am5d$ to read z foll[s3 #cjaf4 ,national ,c5t]s ( ,excell5ce 9 ,cont9u\s ,ph>maceutical ,manufactur+ 7a7 ,9 g5]al ,! ,secret>y ( ,heal? & ,human ,s]vices1 act+ ?r\gh ! ,commission] ( ,food & ,drugs-- 7#a7 %all solicit &1 beg9n+ n lat] ?an "o ye> aft] ! date ( enactm5t ( ! ,national ,c5t]s ( ,excell5ce 9 ,cont9u\s ,ph>maceutical ,manufactur+ ,act ( #bjbj1 receive reque/s f in/itutions ( high] education to be designat$ z a ,national ,c5t] ( ,excell5ce 9 ,cont9u\s ,ph>maceutical ,manufactur+ 79 ?is section ref]r$ to z a ,national ,c5t] ( ,excell5ce7 to support ! advancem5t & developm5t ( cont9u\s manufactur+2 & 7#b7 %all s designate any in/itution ( high] education t-- 7,a7 reque/s su* designation2 & 7,b7 meets ! crit]ia specifi$ 9 subsection 7c74 7b7 ,reque/ = designation ,a reque/ = designation "u subsection 7a7 %all be made to ! ,secret>y at su* "t1 9 su* mann]1 & conta9+ su* in=mation z ! ,secret>y may require4 ,any su* reque/ %all include a description ( h[ ! in/itution ( high] education meets or plans to meet ea* ( ! crit]ia specifi$ 9 subsection 7c74 7c7 ,crit]ia = designation describ$ ,! crit]ia specifi$ 9 ?is subsection ) respect to an in/itution ( high] education are t ! in/itution has1 z ( ! date ( ! submission ( a reque/ "u subsection 7a7 by su* in/itution-- 7#a7 physical & te*nical capacity = rese>* & developm5t ( cont9u\s manufactur+2 7#b7 manufactur+ k-%>+ networks ) o!r in/itutions ( high] education1 l>ge & small ph>maceutical manufactur]s1 g5]ic & nonprescription manufactur]s1 contract manufactur]s1 & o!r entities2 7#c7 prov5 capacity to design & demon/rate new1 highly effective te*nology = use 9 cont9u\s manufactur+2 7#d7 a track record = creat+ & transf]r+ k ) respect to cont9u\s manufactur+2 7#e7 ! pot5tial to tra9 a future work=ce = rese>* on & implem5tation ( advanc$ manufactur+ & cont9u\s manufactur+2 & 7#f7 exp]i5ce 9 p>ticipat+ 9 & lead+ a cont9u\s manufactur+ te*nology p>tn]%ip ) o!r in/itutions ( high] education1 l>ge & small ph>maceutical manufactur]s1 g5]ic & nonprescription manufactur]s1 contract manufactur]s1 & o!r entities-- 7,a7 to support companies ) cont9u\s manufactur+ 9 ! ,unit$ ,/ates2 7,b7 to support ,f$]al ag5cies ) te*nical assi/ance1 :i* may include regulatory & quality metric guidance z applicable1 = advanc$ manufactur+ & cont9u\s manufactur+2 7,c7 ) respect to cont9u\s manufactur+1 to organize & conduct rese>* & developm5t activities ne$$ to create new & m effective te*nology1 capture & dissem9ate exp]tise1 create intellectual prop]ty1 & ma9ta9 te*nological lead]%ip2 7,d7 to develop be/ practices = design+ cont9u\s manufactur+2 & 7,e7 to assess & respond to ! work=ce ne$s = cont9u\s manufactur+1 includ+ ! developm5t ( tra9+ programs if ne$$4 7d7 ,t]m9ation ( designation ,! ,secret>y may t]m9ate ! designation ( any ,national ,c5t] ( ,excell5ce designat$ "u ?is section if ! ,secret>y det]m9es su* ,national ,c5t] ( ,excell5ce no long] meets ! crit]ia specifi$ 9 subsection 7c74 ,n lat] ?an #fj days be=e ! effective date ( su* a t]m9ation1 ! ,secret>y %all provide writt5 notice to ! ,national ,c5t] ( ,excell5ce1 includ+ ! rationale = su* t]m9ation4 7e7 ,conditions = designation ,z a condition ( designation z a ,national ,c5t] ( ,excell5ce "u ?is section1 ! ,secret>y %all require t an in/itution ( high] education ent] into an agreem5t ) ! ,secret>y "u :i* ! in/itution agrees-- 7#a7 to collaborate directly ) ! ,food & ,drug ,adm9i/ration to publi% ! reports requir$ by subsection 7g72 7#b7 to %>e data ) ! ,food & ,drug ,adm9i/ration reg>d+ be/ practices & rese>* g5]at$ ?r\gh ! fund+ "u subsection 7f72 7#c7 to develop1 along ) indu/ry p>tn]s 7:i* may include l>ge & small bioph>maceutical manufactur]s1 g5]ic & nonprescription manufactur]s1 & contract manufactur]s7 & ano!r in/itution or in/itutions designat$ "u ?is section1 if any1 a roadmap = develop+ a cont9u\s manufactur+ work=ce2 7#d7 to develop1 along ) indu/ry p>tn]s & o!r in/itutions designat$ "u ?is section1 a roadmap = /r5g!n+ exi/+1 & develop+ new1 relation%ips ) o!r in/itutions2 & 7#e7 to provide an annual report to ! ,food & ,drug ,adm9i/ration reg>d+ ! in/itution's activities "u ?is section1 includ+ a description ( h[ ! in/itution cont9ues to meet & make progress on ! crit]ia li/$ 9 subsection 7c74 7f7 ,fund+ 7#a7 ,9 g5]al ,! ,secret>y %all aw>d fund+1 ?r\gh grants1 contracts1 or coop]ative agreem5ts1 to ! ,national ,c5t]s ( ,excell5ce designat$ "u ?is section = ! purpose ( /udy+ & recomm5d+ improvem5ts to cont9u\s manufactur+1 includ+ su* improvem5ts z may enable ! ,c5t]s-- 7,a7 to cont9ue to meet ! conditions specifi$ 9 subsection 7e72 & 7,b7 to exp& capacity = rese>* on1 & developm5t (1 cont9u+ manufactur+4 7#b7 ,consi/5cy ) ,,fda mission ,z a condition on receipt ( fund+ "u ?is subsection1 a ,national ,c5t] ( ,excell5ce %all agree to consid] any input f ! ,secret>y reg>d+ ! use ( fund+ t w\ld-- 7,a7 help to fur!r ! advancem5t ( cont9u\s manufactur+ ?r\gh ! ,national ,c5t] ( ,excell5ce2 & 7,b7 be relevant to ! mission ( ! ,food & ,drug ,adm9i/ration4 7#c7 ,au?orization ( appropriations ,!re is au?oriz$ to be appropriat$ to c>ry out ?is subsection #hj1jjj1jjj = ! p]iod ( fiscal ye>s #bjba ?r\gh #bjbe4 7#d7 ,rule ( con/ruction ,no?+ 9 ?is section %all be con/ru$ z preclud+ a ,national ,c5t] = ,excell5ce designat$ "u ?is section f receiv+ funds "u any o!r provision ( ?is ,act or any o!r ,f$]al law4 7g7 ,annual review & reports 7#a7 ,annual report ,beg9n+ n lat] ?an "o ye> aft] ! date on :i* ! fir/ designation is made "u subsection 7a71 & annually !reaft]1 ! ,secret>y %all-- 7,a7 submit to ,congress a report describ+ ! activities1 p>tn]%ips & collaborations1 ,f$]al policy recomm5dations1 previ\s & cont9u+ fund+1 & f9d+s (1 & any o!r applicable in=mation f1 ! ,national ,c5t]s ( ,excell5ce designat$ "u ?is section2 & 7,b7 make su* report available to ! public 9 an easily accessible electronic =mat on ! website ( ! ,food & ,drug ,adm9i/ration4 7#b7 ,review ( national c5t]s ( excell5ce & pot5tial designees ,! ,secret>y %all p]iodically review ! ,national ,c5t]s ( ,excell5ce designat$ "u ?is section to ensure t su* ,national ,c5t]s ( ,excell5ce cont9ue to meet ! crit]ia = designation "u ?is section4 7#c7 ,report on long-t]m vision ( ,,fda role ,n lat] ?an #b ye>s aft] ! date on :i* ! fir/ designation is made "u subsection 7a71 ! ,secret>y1 9 consultation ) ! ,national ,c5t]s ( ,excell5ce designat$ "u ?is section1 %all submit a report to ! ,congress on ! long-t]m vision ( ! ,dep>tm5t ( ,heal? & ,human ,s]vices on ! role ( ! ,food & ,drug ,adm9i/ration 9 support+ cont9u\s manufactur+1 includ+-- 7,a7 a national framework ( pr9ciples relat$ to ! implem5tation & regulation ( cont9u\s manufactur+2 7,b7 a plan = ! developm5t ( ,f$]al regulations & guidance = h[ advanc$ manufactur+ & cont9u\s manufactur+ c be incorporat$ into ! developm5t ( ph>maceuticals & regulatory responsibilities ( ! ,food & ,drug ,adm9i/ration2 & 7,c7 appropriate fe$back solicit$ f ! public1 :i* may include o!r in/itutions1 l>ge & small bioph>maceutical manufactur]s1 g5]ic & nonprescription manufactur]s1 & contract manufactur]s4 7h7 ,def9itions ,9 ?is section3 7#a7 ,advanc$ manufactur+ ,! t]m advanc$ manufactur+ means an approa* = ! manufactur+ ( ph>maceuticals t incorporates novel te*nology1 or uses an e/abli%$ te*nique or te*nology 9 a new or innovative way 7su* z cont9u\s manufactur+ :]e ! input mat]ials are cont9u\sly trans=m$ )9 ! process by two or m unit op]ations7 t enhances drug quality or improves ! manufactur+ process4 7#b7 ,cont9u\s manufactur+ ,! t]m cont9u\s manufactur+-- 7,a7 means a process :]e ! input mat]ials are cont9u\sly f$ into & trans=m$ )9 ! process1 & ! process$ output mat]ials are cont9u\sly remov$ f ! sy/em2 & 7,b7 consi/s ( an integrat$ process t consi/s ( a s]ies ( two or m unit op]ations4 7#c7 ,in/itution ( high] education ,! t]m in/itution ( high] education has ! mean+ giv5 su* t]m 9 section #aja7;a7 ( ! ,high] ,education ,act ( #aife 7#bj ,u4,s4,c4 #ajja7;a774 7#d7 ,secret>y ,! t]m ,secret>y means ! ,secret>y ( ,heal? & ,human ,s]vices1 act+ ?r\gh ! ,commission] ( ,food & ,drugs4 4 7b7 ,transition rule ,section #cjaf ( ! #ba/ ,c5tury ,cures ,act 7#ba ,u4,s4,c4 #cii;h71 z 9 effect on ! day be=e ! date ( ! enactm5t ( ?is section1 %all apply ) respect to grants aw>d$ "u su* section be=e su* date ( enactm5t4 ,septemb] #ag1 #bjbj,report$ ) an am5dm5t2 committ$ to ! ,committee ( ! ,:ole ,h\se on ! ,/ate ( ! ,union & ord]$ to be pr9t$