,,ii #aag? ,,congress #b;d ,session ,s4 #cehh ,,9 ,,! ,,s5ate ,,( ,,! ,,unit$ ,,/ates ,febru>y #g 7legislative day1 ,febru>y #c71 #bjbb,mr4 ,romney 7= himself & ,ms4 ,hassan7 introduc$ ! foll[+ bill2 :i* 0 read twice & ref]r$ to ! ,committee on ,heal?1 ,education1 ,labor1 & ,p5sions ,a ,,bill ,to am5d ! ,public ,heal? ,s]vice ,act to improve dome/ic manufactur+ surge capacity & capabilities = biodef5se & p&emic prep>$ness4 #a4 ,%ort title ,?is ,act may be cit$ z ! ,m$ical ,c\nt]measures ,surge ,capacity ,act ( #bjbb4 #b4 ,w>m base manufactur+ capacity = m$ical c\nt]measures 7a7 ,9 g5]al ,section #cai,l ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bdg;d-#g;e7 is am5d$-- 7#a7 9 subsection 7a77#f77;,b7-- 7,a7 by r$esignat+ clauses 7iv7 & 7v7 z clauses 7v7 & 7vi71 respectively2 7,b7 by ins]t+ aft] clause 7iii71 ! foll[+3 7iv7 activities to support1 ma9ta91 & improve dome/ic manufactur+ surge capacity & capabilities1 z appropriate1 includ+ ?r\gh ! utilization ( advanc$ manufactur+ & plat=m te*nologies1 to increase ! availability ( products t are or may become qualifi$ c\nt]measures or qualifi$ p&emic or epidemic products2 2 & 7,c7 9 clause 7vi7 7z s r$esignat$71 by ins]t+ manufactur+1 aft] improvem5t12 7#b7 9 subsection 7b7-- 7,a7 9 ! fir/ s5t5ce ( p>agraph 7#a71 by ins]t+ support = dome/ic manufactur+ surge capacity & capabilities1 aft] initiatives = innovation12 & 7,b7 9 p>agraph 7#b7-- 7i7 9 subp>agraph 7,b71 by /rik+ & at ! end2 7ii7 by r$esignat+ subp>agraph 7,c7 z subp>agraph 7,d72 & 7iii7 by ins]t+ aft] subp>agraph 7,b71 ! foll[+3 7,c7 activities to support1 ma9ta91 & improve dome/ic manufactur+ surge capacity & capabilities1 z appropriate1 includ+ ?r\gh ! utilization ( advanc$ manufactur+ & plat=m te*nologies1 to increase ! availability ( products t are or may become qualifi$ c\nt]measures or qualifi$ p&emic or epidemic products2 & 2 7#c7 9 subsection 7c7-- 7,a7 9 p>agraph 7#b77;,b71 by ins]t+ be=e ! semicolon 1 includ+ ?r\gh ! e/abli%m5t & ma9t5ance ( dome/ic manufactur+ surge capacity & capabilities1 consi/5t ) subsection 7a77#f77;,b77iv72 7,b7 9 p>agraph 7#d7-- 7i7 9 subp>agraph 7,a7-- 7,i7 9 clause 7i7-- 7aa7 9 subclause 7,i71 by /rik+ & at ! end2 & 7bb7 by add+ at ! end ! foll[+3 7,,iii7 facilitat+ su* communication1 z appropriate1 reg>d+ manufactur+ surge capacity & capabilities ) respect to qualifi$ c\nt]measures & qualifi$ p&emic or epidemic products to prep>e =1 or respond to1 a public heal? em]g5cy or pot5tial public heal? em]g5cy2 & 7,,iv7 facilitat+ su* communication1 z appropriate & 9 a mann] t does n compromise national security1 ) respect to pot5tial eligibility = ! mat]ial ?reat m$ical c\nt]measure priority review v\*] program "u section #efe;,a ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act2 2 7,,ii7 9 clause 7ii77,,iii71 by /rik+ & at ! end2 7,,iii7 by r$esignat+ clause 7iii7 z clause 7iv72 & 7,,iv7 by ins]t+ aft] clause 7ii71 ! foll[+3 7iii7 communicate regul>ly ) entities 9 receipt ( an aw>d pursuant to subp>agraph 7,b77v71 & facilitate communication betwe5 su* entities & o!r entities 9 receipt ( an aw>d pursuant to subp>agraph 7,b77iv71 z appropriate1 = purposes ( plann+ reg>d+ ! availability ( c\nt]measures & ! ma9t5ance ( dome/ic manufactur+ surge capacity & capabilities1 includ+ any plann$ uses ( su* capacity & capabilities 9 ! ne>- & mid-t]m1 & id5tification ( any significant *all5ges relat$ to ! long-t]m ma9t5ance ( su* capacity & capabilities2 & 2 7ii7 9 subp>agraph 7,b7-- 7,i7 9 clause 7iii71 by /rik+ & at ! end2 7,,ii7 9 clause 7iv71 by /rik+ ! p]iod & ins]t+ 2 &2 & 7,,iii7 by add+ at ! end ! foll[+3 7v7 aw>d contracts1 grants1 & coop]ative agreem5ts & ent] into o!r transactions to support1 ma9ta91 & improve dome/ic manufactur+ surge capacity & capabilities1 includ+ ?r\gh support+ flexible or advanc$ manufactur+1 to ensure t additional capacity is available to rapidly manufacture products t are or may become qualifi$ c\nt]measures or qualifi$ p&emic or epidemic products 9 ! ev5t ( a public heal? em]g5cy decl>ation or significant pot5tial = a public heal? em]g5cy4 2 7iii7 9 subp>agraph 7,c7-- 7,i7 9 clause 7i71 by /rik+ & at ! end2 7,,ii7 9 clause 7ii71 by /rik+ ! p]iod at ! end & ins]t+ 2 &2 & 7,,iii7 by add+ at ! end ! foll[+3 7iii7 consult ) ! ,commission] ( ,food & ,drugs1 pursuant to section #efe7;b77#b7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act1 to ensure t facilities p]=m+ manufactur+1 pursuant to an aw>d "u subp>agraph 7,b77v71 are 9 compliance ) applicable requirem5ts "u su* ,act & ?is ,act1 z appropriate1 includ+ curr5t good manufactur+ practice pursuant to section #eja7;a77#b77;,b7 ( ! ,food1 ,drug1 & ,cosmetic ,act2 & 2 7iv7 9 subp>agraph 7,d77i71 by ins]t+ 1 includ+ to improve manufactur+ capacities & capabilities = m$ical c\nt]measures be=e ! semicolon2 7v7 9 subp>agraph 7,e77ix71 by /rik+ #bjbc & ins]t+ #bjbh2 & 7vi7 by add+ at ! end ! foll[+3 7,g7 ,annual reports by aw>d recipi5ts ,z a condition ( receiv+ an aw>d "u subp>agraph 7,b77v71 a recipi5t %all develop & submit to ! ,secret>y annual reports relat$ to ! ma9t5ance ( su* capacity & capabilities1 includ+ ensur+ t su* capacity & capabilities are able to support ! rapid manufacture ( c\nt]measures z requir$ by ! ,secret>y4 2 & 7,c7 9 p>agraph 7#e71 by add+ at ! end ! foll[+3 7,h7 ,support+ w>m-base & surge capacity & capabilities ,pursuant to an aw>d "u subp>agraph 7,b77v71 ! ,secret>y may make paym5ts = activities necess>y to ma9ta9 dome/ic manufactur+ surge capacity & capabilities support$ "u su* aw>d to ensure t su* capacity & capabilities are able to support ! rapid manufacture ( c\nt]measures z requir$ by ! ,secret>y to prep>e =1 or respond to1 an exi/+ or pot5tial public heal? em]g5cy or o!rwise address ?reats t pose a significant level ( risk to national security4 ,! ,secret>y may support ! utilization ( su* capacity & capabilities "u aw>ds = c\nt]measure & product advanc$ rese>* & developm5t1 z appropriate1 to provide = ! ma9t5ance ( su* capacity & capabilities4 2 & 7#d7 9 subsection 7f7-- 7,a7 9 p>agraph 7#a71 by /rik+ ,n lat] ?an #ahj days aft] ! date ( enactm5t ( ?is subsection & ins]t+ ,n lat] ?an #ahj days aft] ! date ( enactm5t ( ! ,m$ical ,c\nt]measures ,surge ,capacity ,act ( #bjbb2 7,b7 9 p>agraph 7#b7-- 7i7 9 ! matt] prec$+ subp>agraph 7,a71 by /rik+ ?is subsection & ins]t+ ! ,m$ical ,c\nt]measures ,surge ,capacity ,act ( #bjbb2 7ii7 9 subp>agraph 7,b71 by /rik+ & at ! end2 & 7iii7 9 subp>agraph 7,c71 by /rik+ ! p]iod & ins]t+ 2 &2 & 7,c7 by add+ at ! end ! foll[+3 7,d7 plans = ! ne>-1 mid-1 & long-t]m su/a9m5t ( manufactur+ activities c>ri$ out "u ?is section1 includ+ su* activities pursuant to subsection 7c77#e77;,h71 specific actions to regul>ly assess ! ability ( recipi5ts ( an aw>d "u subsection 7c77#d77;,b77v7 to rapidly manufacture c\nt]measures z requir$ by ! ,secret>y1 & recomm5dations to address *all5ges1 if any1 relat$ to su* activities4 4