,,ii #aag? ,,congress #a/ ,session ,s4 #aagf ,,9 ,,! ,,s5ate ,,( ,,! ,,unit$ ,,/ates ,april #ae1 #bjba,ms4 ,smi? 7= h]self & ,mr4 ,cassidy7 introduc$ ! foll[+ bill2 :i* 0 read twice & ref]r$ to ! ,committee on ,heal?1 ,education1 ,labor1 & ,p5sions ,a ,,bill ,to e/abli% a grant program to support ! manufacture & /ockpil+ ( ess5tial g5]ic antibiotic drugs4 #a4 ,%ort title ,?is ,act may be cit$ z ! ,on%or+ ,ess5tial ,antibiotics ,act4 #b4 ,ess5tial g5]ic antibiotic program 7a7 ,grant program 7#a7 ,e/abli%m5t ,n lat] ?an #fj days aft] ! date ( enactm5t ( ?is ,act1 ! ,secret>y %all e/abli% a program to provide grants to manufactur]s ( ess5tial g5]ic antibiotic drugs1 or ! active ph>maceutical +r$i5t or key />t+ mat]ial ( an ess5tial g5]ic antibiotic drug1 to support activities describ$ 9 p>agraph 7#c74 7#b7 ,eligible entities ,! ,secret>y %all aw>d grants "u ?is subsection to n m ?an #c manufactur]s ( an ess5tial g5]ic antibiotic drug4 ,ea* su* recipi5t %all be a manufactur] t-- 7,a7 has implem5t$ & ma9ta9s an effective quality managem5t sy/em1 "u p>ts #baj & #baa ( title #ba1 ,code ( ,f$]al ,regulations 7or any successor regulations72 7,b7 has a /rong record ( compliance ) ! requirem5ts ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cja et seq472 7,c7 uses complex ph>maceutical manufactur+ to produce a f9i%$ drug product or active ph>maceutical +r$i5t pursuant to an application approv$ "u section subsection 7c7 or 7j7 ( section #eje ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cee72 7,d7 commits to us+ advanc$ manufactur+ 9 its manufactur+ op]ations2 & 7,e7 has exi/+ manufactur+ facilities & op]ations 9 ! ,unit$ ,/ates4 7#c7 ,use ( funds ,a recipi5t ( a grant "u ?is subsection may use su* grant funds to-- 7,a7 ) respect to manufactur+ an ess5tial g5]ic antibiotic drug-- 7i7 exp&1 upgrade1 or recommission an exi/+ manufactur+ facility locat$ 9 ! ,unit$ ,/ates2 or 7ii7 con/ruct a new manufactur+ facility 9 ! ,unit$ ,/ates2 & 7,b7 manufacture ess5tial g5]ic antibiotic drugs4 7b7 ,use ( funds ,to pur*ase ess5tial g5]ic antibiotic drugs = /ockpil+ ,! ,secret>y may use am\nts appropriat$ "u ?is section to pur*ase1 /ore1 /ockpile1 or disposition ess5tial g5]ic antibiotic drugs manufactur$ 9 ! ,unit$ ,/ates4 7c7 ,def9itions ,= purposes ( ?is section3 7#a7 ,active ph>maceutical +r$i5t ,! t]m active ph>maceutical +r$i5t has ! mean+ giv5 su* t]m 9 section #gdd;,a ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;j-#da74 7#b7 ,ess5tial g5]ic antibiotic drug ,! t]m ess5tial g5]ic antibiotic drug means an antibact]ial or antifungal drug approv$ by ! ,food & ,drug ,adm9i/ration "u section #eje7;j7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cee7;j77 t ! ,secret>y det]m9es to be m$ically necess>y to h available at all times 9 an am\nt adequate to s]ve pati5t ne$s1 includ+ beta-lactams 7includ+ p5icill9 & cephalospor9 d]ivatives7 & non-beta lactams 7includ+ tetracycl9e & am9oglycoside d]ivatives74 7#c7 ,key />t+ mat]ial ,! t]m key />t+ mat]ial means any compon5t ( a drug t ! ,secret>y det]m9es to be critical to ! safety & effectiv5ess ( ! drug4 7#d7 ,secret>y ,! t]m ,secret>y means ! ,secret>y ( ,heal? & ,human ,s]vices4 7#e7 ,unit$ ,/ates ,! t]m ,unit$ ,/ates means ! #ej ,/ates1 ! ,di/rict ( ,columbia1 t]ritories1 & ,tribal l&s4 7d7 ,fund+ ,= purposes ( c>ry+ out ?is section1 !re is appropriat$1 out ( am\nts 9 ! ,treasury n o!rwise appropriat$1 #ejj1jjj1jjj = fiscal ye> #bjba1 to rema9 available ?r\gh ,septemb] #cj1 #bjbc4 #c4 ,/udy & report 7a7 ,9 g5]al ,! ,secret>y ( ,heal? & ,human ,s]vices 7ref]r$ to 9 ?is section z ! ,secret>y7 %all ent] into a contract ) an entity "u :i* su* entity c>ries out a /udy on ! manufacture ( ess5tial g5]ic antibiotic drugs & issues a report t includes-- 7#a7 recomm5dations ab\t :i* antibiotics ! ,secret>y %\ld prioritize = purposes ( ! program "u section #b1 bas$ on factors t include necessity ( use1 vuln]ability to =eign supply *a9 disruptions1 & availability ( alt]natives2 & 7#b7 ! expect$ effect ( increas$ dome/ic manufactur+ ( drugs on drug co/s to consum]s4 7b7 ,au?orization ,to c>ry out ?is section1 !re is au?oriz$ to be appropriat$ #b1jjj1jjj = fiscal ye> #bjba1 to rema9 available until ,septemb] #cj1 #bjbb4