,i #aaf? ,,congress #b;d ,session ,h4 ,r4 #fgjh ,,9 ,,! ,,h\se ,,( ,,repres5tatives ,may #e1 #bjbj,mr4 ,bu*anan introduc$ ! foll[+ bill2 :i* 0 ref]r$ to ! ,committee on ,en]gy & ,comm]ce ,a ,,bill ,to support ! advanc$ manufactur+ te*nologies program ( ! ,food & ,drug ,adm9i/ration1 to e/abli% ,national ,c5t]s ( ,excell5ce 9 ,advanc$ ,ph>maceutical ,manufactur+1 & = o!r purposes4 #a4 ,%ort title ,?is ,act may be cit$ z ! ,secur+ ,am]ica's ,m$ic9e ,cab9et ,act ( #bjbj4 #b4 ,advanc$ manufactur+ te*nologies program ,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;,b4 ,advanc$ manufactur+ te*nologies program 7a7 ,9 g5]al ,n lat] ?an #a ye> aft] ! date ( enactm5t ( ! ,secur+ ,am]ica's ,m$ic9e ,cab9et ,act ( #bjbj1 ! ,secret>y %all cont9ue 9 effect ! program to evaluate & approve new drug manufactur+ te*nologies t are includ$ 9 an application1 or supplem5t to an application1 = a drug "u subsection 7b7 or 7j7 ( section #eje ( ?is ,act or = a biological product submitt$ "u subsection 7a7 or 7k7 ( section #cea ( ! ,public ,heal? ,s]vice ,act4 7b7 ,designation ,! ,secret>y %all designate a me?od ( manufactur+ a drug z an advanc$ manufactur+ te*nology "u ?is section if ! drug manufactur] demon/rates t su* te*nology is likely to-- 7#a7 prev5t or resolve a drug %ortage2 7#b7 ma9ta9 an adequate supply ( critical m$ications = national em]g5cies2 or 7#c7 promote ! adoption ( innovative approa*es to drug product design & manufactur+4 7c7 ,consultation ,if ! ,secret>y designates a me?od ( manufactur+ z an advanc$ manufactur+ te*nology "u ?is section1 ! ,secret>y %all take actions to exp$ite ! developm5t & implem5tation ( su* me?od ( manufacture = purposes ( approval ( ! application "u subsection 7c7 or 7j7 ( section #eje ( ?is ,act or subsection 7a7 or 7k7 ( section #cea ( ! ,public ,heal? ,s]vice ,act1 :i* may include1 z appropriate-- 7#a7 hold+ meet+s betwe5 ! sponsor ( ! application & appropriate ,food & ,drug ,adm9i/ration /aff ?r\gh\t ! developm5t ( ! te*nology2 7#b7 provid+ timely advice to1 & int]active communication )1 ! sponsor reg>d+ ! developm5t ( ! te*nology2 & 7#c7 involv+ s5ior manag]s & exp]i5c$ /aff ( ! ,food & ,drug ,adm9i/ration1 z appropriate1 9 a collaborative1 cross-discipl9>y review ( ! me?od ( manufactur+4 7d7 ,evaluation ( an ,advanc$ ,manufactur+ ,te*nology 7#a7 ,package ,a sponsor :o receives designation ( an advanc$ manufactur+ te*nology "u ?is section %all provide ! ,secret>y ) a package ( sci5tific evid5ce support+ ! implem5tation ( ! advanc$ manufactur+ te*nology 9 a p>ticul> context-(-use4 7#b7 ,evaluation ,)9 #ij days ( receiv+ ! package1 ! ,secret>y %all det]m9e :e!r a designat$ advanc$ manufactur+ te*nology is validat$ = ! propos$ context ( use bas$ on ! sci5tific m]it ! support+ evid5ce provid$ by ! sponsor4 7#c7 ,effect ( ,approval ,^u approval1 ! same sponsor may rely ^u ! advanc$ manufactur+ te*nology = use across multiple manufactur+ product l9es )9 ! same context-(-use )\t hav+ to re-submit data to ! ,secret>y validat+ ! und]ly+ te*nology4 7e7 ,implem5tation & ,report+ 7#a7 ,public meet+ ,! ,secret>y %all publi% 9 ! ,f$]al ,regi/] a notice ( a public meet+ to be held no lat] ?an #a ye> aft] ! date ( enactm5t ( ! ,secur+ ,am]ica's ,m$ic9e ,cab9et ,act ( #bjbj to discuss & obta9 input & recomm5dations f /akehold]s reg>d+ ! goals & scope (1 & a suitable framework & proc$ures & requirem5ts =1 ! program "u ?is section4 7#b7 ,program guidance ,! ,secret>y %all-- 7,a7 n lat] ?an #a ye> aft] ! date ( enactm5t ( ! ,secur+ ,am]ica's ,m$ic9e ,cab9et ,act ( #bjbj1 issue draft guidance reg>d+ ! goals & implem5tation ( ! program "u ?is section2 & 7,b7 n lat] ?an #b ye>s aft] ! date ( enactm5t ( ! ,secur+ ,am]ica's ,m$ic9e ,cab9et ,act ( #bjbj1 issue f9al guidance ) respect to ! implem5tation ( su* program4 7#c7 ,report ,! ,secret>y %all make available on ! int]net website ( ! ,food & ,drug ,adm9i/ration an annual report on ! progress ( ! program "u ?is section4 4 #c4 ,national ,c5t] ( ,excell5ce 9 ,advanc$ ,ph>maceutical ,manufactur+ ,*apt] ,x ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cia et seq47 is am5d$ by add+ at ! end ! foll[+3 #ajae4 ,national ,c5t] ( ,excell5ce 9 ,advanc$ ,ph>maceutical ,manufactur+ 7a7 ,9 g5]al ,! ,secret>y %all designate in/itutions ( high] education z ,national ,c5t]s ( ,excell5ce 9 ,advanc$ ,ph>maceutical ,manufactur+1 includ+ cont9u\s ph>maceutical manufactur+4 7b7 ,eligibility ,to be eligible = designation "u subsection 7a7 an entity %all-- 7#a7 be an in/itution ( high] education2 7#b7 demon/rate-- 7,a7 ! physical & te*nical capacity = rese>* & developm5t ( advanc$ ph>maceutical manufactur+2 7,b7 a record ( transf]r+ sci5tific k to ! m>ketplace2 7,c7 scalable manufactur+ k1 :i* may be ?r\gh collaborations ( o!r in/itutions ( high] education1 bioph>maceutical manufactur]s1 or o!r entities2 7,d7 ! ability to tra9 a future work=ce = rese>* on & implem5tation ( advanc$ ph>maceutical manufactur+2 & 7,e7 ! ability to support ,f$]al ag5cies ) te*nical assi/ance = advanc$ ph>maceutical te*nologies1 ) an emphasis on creat+ a secure national ph>maceutical /ockpile & ! ability to rapidly address drug %ortages2 & 7#c7 submit an application to ! ,secret>y at su* "t1 9 su* =m1 & 9 su* mann] z ! ,secret>y may require4 7c7 ,t]m9ation ,! ,secret>y may t]m9ate ! designation ( an entity designat$ "u subsection 7a7 ^u a det]m9ation t ! entity no long] meets ! requirem5ts ( subsection 7b74 7d7 ,annual report ,n lat] ?an #a ye> aft] ! date on :i* ! fir/ designation is made "u subsection 7a71 & annually !reaft]1 ! ,secret>y %all submit a report to ,congress on ! activities ( ! entities designat$ "u su* subsection4 7e7 ,au?orization ( appropriations ,to c>ry out ?is section1 !re are au?oriz$ to be appropriat$ #ajj1jjj1jjj = ! p]iod ( fiscal ye> #bjba ?r\gh #bjbe4 4