,,ii ,cal5d> ,no4 #chh #aad? ,,congress #b;d ,session ,s4 #bjee ,,9 ,,! ,,s5ate ,,( ,,! ,,unit$ ,,/ates ,septemb] #ag1 #bjae,mr4 ,burr 7= himself1 ,mr4 ,casey1 ,mr4 ,isakson1 & ,mr4 ,rob]ts7 introduc$ ! foll[+ bill2 :i* 0 read twice & ref]r$ to ! ,committee on ,heal?1 ,education1 ,labor1 & ,p5sions ,m>* #ad1 #bjaf,report$ by ,mr4 ,alex&]1 ) an amendment,strike out all aft] ! enact+ clause & ins]t ! "p pr9t$ 9 italic ,a ,,bill ,to am5d ! ,public ,heal? ,s]vice ,act & ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act ) respect to national heal? security4 #a4 ,%ort title ,?is ,act may be cit$ z ! ,m$ical ,c\nt]measure ,innovation ,act ( #bjae4 #b4 ,m$ical c\nt]measure guidel9es 7a7 ,/rategic national /ockpile & security c\nt]measure procurem5ts ,section #cai;,f-#b ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bdg;d-#f;b7 is am5d$-- 7#a7 9 subsection 7a71 by add+ at ! end ! foll[+3 7#c7 ,utilization guidel9es ,! ,secret>y %all ensure timely & accurate recomm5d$ utilization guidel9es = qualifi$ c\nt]measures 7z def9$ 9 section #cai;,f-#a71 qualifi$ p&emic & epidemic products 7z def9$ 9 section #cai;,f-#c71 & security c\nt]measures 7z def9$ 9 subsection 7c771 includ+ = su* products 9 ! /ockpile4 2 & 7#b7 9 subsection 7g7-- 7,a7 by am5d+ p>agraph 7#d7 to read z foll[s3 7#d7 ,report on security c\nt]measure procurem5t ,n lat] ?an ,m>* #a ( ea* ye> 9 :i* ! ,secret>y det]m9es t ! am\nt ( funds available = procurem5t ( security c\nt]measures is less ?an #a1ejj1jjj1jjj1 ! ,secret>y %all submit to ! ,committee on ,appropriations & ! ,committee on ,heal?1 ,education1 ,labor1 & ,p5sions ( ! ,s5ate & ! ,committee on ,appropriations & ! ,committee on ,en]gy & ,comm]ce ( ! ,h\se ( ,repres5tatives a report detail+ ! am\nt ( su* funds available = procurem5t & ! impact su* am\nt ( fund+ w h-- 7,a7 9 meet+ ! security c\nt]measure ne$s id5tifi$ "u ?is section2 & 7,b7 on ! annual ,public ,heal? ,em]g5cy ,m$ical ,c\nt]measures ,ent]prise & ,/rategy ,implem5tation ,plan 7pursuant to section #bhaa7;d774 4 #c4 ,cl>ification on ,,b>da contract+ au?ority 7a7 ,9 g5]al ,section #cai;,f-#b7;g7 ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bdg;d-#f;b7g77 is am5d$ by add+ at ! end ! foll[+3 7#e7 ,cl>ification on contract+ au?ority ,! ,secret>y1 act+ ?r\gh ! ,director ( ! ,biom$ical ,advanc$ ,rese>* & ,developm5t ,au?ority1 %all c>ry out ! programs fund$ by ! special res]ve fund 7= ! procurem5t ( security c\nt]measures "u subsection 7c7 & = c>ry+ out section #cai,l71 includ+ ! execution ( procurem5t contracts1 grants1 & coop]ative agreem5ts pursuant to ?is section & section #cai,l4 4 7b7 ,,b>da contract+ au?ority ,section #cai,l7c77#c7 ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bdg;d-#g;c7 is am5d$ by ins]t+ 1 includ+ ! execution ( procurem5t contracts1 grants1 & coop]ative agreem5ts pursuant to ?is section be=e ! p]iod4 #d4 ,c\nt]measures budget plan ,section #bhaa7;b77#g7 ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #cjj;hh-#aj7;b77#g77 is am5d$-- 7#a7 by /rik+ ! fir/ s5t5ce & ins]t+ ,develop1 & update n lat] ?an ,m>* #a ( ea* ye>1 a coord9at$ #e-ye> budget plan bas$ on ! m$ical c\nt]measure priorities describ$ 9 subsection 7d71 includ+ ) respect to *emical1 biological1 radiological1 & nucle> ag5t or ag5ts t may pres5t a ?reat to ! ,nation1 includ+ su* ag5ts t are novel or em]g+ infecti\s diseases1 & ! correspond+ ef=ts to develop qualifi$ c\nt]measures 7z def9$ 9 section #cai;,f-#a71 security c\nt]measures 7z def9$ 9 section #cai;,f-#b71 & qualifi$ p&emic or epidemic products 7z def9$ 9 section #cai;,f-#c7 = ea* su* ?reat42 7#b7 9 subp>agraph 7,c71 by /rik+ 2 & & ins]t+ a semicolon2 7#c7 9 subp>agraph 7,d71 by /rik+ to ! appropriate committees ( ,congress ^u reque/4 & ins]t+ 1 n lat] ?an ,m>* #ae ( ea* ye>1 to ! ,committee on ,appropriations & ! ,committee on ,heal?1 ,education1 ,labor1 & ,p5sions ( ! ,s5ate & ! ,committee on ,appropriations & ! ,committee on ,en]gy & ,comm]ce ( ! ,h\se ( ,repres5tatives2 &2 & 7#d7 by add+ at ! end ! foll[+3 7,e7 n lat] ?an ,m>* #ae ( ea* ye>1 be made publicly available4 4 #e4 ,prioritiz+ ! animal rule guidance ,section #efe7;c7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;bbb-#d7;c77 is am5d$ by add+ at ! end ! foll[+3 7#c7 ,writt5 explanation ,! ,secret>y %all provide to ! ,committee on ,heal?1 ,education1 ,labor1 & ,p5sions ( ! ,s5ate & ! ,committee on ,en]gy & ,comm]ce ( ! ,h\se ( ,repres5tatives a writt5 explanation1 n lat] ?an ! la/ day ( ea* mon? aft] ! date ( enactm5t ( ! ,m$ical ,c\nt]measure ,innovation ,act ( #bjae 9 :i* ! ,secret>y fails to f9alize su* guidance1 = :y ! ,secret>y has fail$ to f9alize ! guidance z requir$ by ?is subsection4 4 #f4 ,/reaml9+ ! project bio%ield procurem5t process ,section #cai;,f-#b7;c7 ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bdg;d-#f;b7c77 is am5d$-- 7#a7 9 p>agraph 7#d77;,a77ii71 by /rik+ make a recomm5dation "u p>agraph 7#f7 t ! special res]ve fund z def9$ 9 subsection 7h7 be made available = ! procurem5t ( su* c\nt]measure & ins]t+ make available ! special res]ve fund z def9$ 9 subsection 7h7 = procurem5t ( su* c\nt]measure1 z applicable2 7#b7 9 p>agraph 7#f7-- 7,a7 by /rik+ subp>agraphs 7,a71 7,b71 & 7,e72 7,b7 by r$esignat+ subp>agraphs 7,c7 & 7,d7 z subp>agraphs 7,a7 & 7,b71 respectively2 7,c7 by am5d+ subp>agraph 7,a71 z s r$esignat$1 to read z foll[s3 7,a7 ,notice to appropriate congressional committees ,! ,secret>y %all notify ! ,committee on ,appropriations & ! ,committee on ,heal?1 ,education1 ,labor1 & ,p5sions ( ! ,s5ate & ! ,committee on ,appropriations & ! ,committee on ,en]gy & ,comm]ce ( ! ,h\se ( ,repres5tatives ( ea* decision to make available ! special res]ve fund z def9$ 9 subsection 7h7 = procurem5t ( a security c\nt]measure1 includ+1 :]e available1 ! numb] (1 ! nature (1 & o!r in=mation conc]n+ pot5tial suppli]s ( su* c\nt]measure1 & :e!r o!r pot5tial suppli]s ( ! same or simil> c\nt]measures 7 consid]$ & reject$ = procurem5t "u ?is section & ! reasons !re=e4 2 & 7,d7 9 ! head+1 by /rik+ ,recomm5dation = presid5t's approval & ins]t+ ,recomm5dations = procurem5t2 & 7#c7 9 p>agraph 7#g7-- 7,a7 by /rik+ subp>agraph 7,a72 7,b7 by /rik+ subp>agraph 7,b7 & ins]t+ ! foll[+3 7,a7 ,paym5ts f special res]ve fund ,! special res]ve fund z def9$ 9 subsection 7h7 %all be available = paym5ts made by ! ,secret>y to a v5dor = procurem5t ( a security c\nt]measure 9 accordance ) ! provisions ( ?is p>agraph4 2 & 7,c7 by r$esignat+ subp>agraph 7,c7 z subp>agraph 7,b74 #g4 ,priority review to enc\rage treatm5ts = ag5ts t pres5t national security ?reats ,sub*apt] ,e ( *apt] ,v ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;bbb et seq47 is am5d$ by ins]t+ aft] section #efe ! foll[+3 #efe;,a4 ,priority review to enc\rage treatm5ts = ag5ts t pres5t national security ?reats 7a7 ,def9itions ,9 ?is section3 7#a7 ,! t]m priority review ) respect to a human drug application z def9$ 9 section #gce7a71 means review & action by ! ,secret>y on su* application n lat] ?an #f mon?s aft] receipt by ! ,secret>y ( su* application1 z describ$ 9 ! ,manual ( ,policies & ,proc$ures 9 ! ,food & ,drug ,adm9i/ration & goals id5tifi$ 9 ! lett]s describ$ 9 section #aja7;b7 ( ! ,food & ,drug ,adm9i/ration ,safety & ,innovation ,act4 7#b7 ,priority review v\*] ,! t]m priority review v\*] means a v\*] issu$ by ! ,secret>y to ! sponsor ( a mat]ial ?reat m$ical c\nt]measure application t entitles ! hold] ( su* v\*] to priority review ( a s+le human drug application submitt$ "u section #eje7;b77#a7 or section #cea ( ! ,public ,heal? ,s]vice ,act aft] ! date ( approval ( ! mat]ial ?reat m$ical c\nt]measure application4 7#c7 ,mat]ial ?reat m$ical c\nt]measure application ,! t]m mat]ial ?reat m$ical c\nt]measure application means an application t-- 7,a7 is a human drug application z def9$ 9 section #gce7a7-- 7i7 to prev5t1 or treat h>m f a biological1 *emical1 radiological1 or nucle> ag5t id5tifi$ z a mat]ial ?reat "u section #cai;,f-#b7;c77#b77;,a77ii7 ( ! ,public ,heal? ,s]vice ,act1 or 7ii7 to mitigate1 prev5t1 or treat h>m f a condition t may result 9 adv]se heal? consequ5ces or dea? & may be caus$ by adm9i/]+ a drug1 or biological product aga9/ su* ag5t2 7,b7 ! ,secret>y deems eligible = priority review2 7,c7 is approv$ aft] ! date ( enactm5t ( ! ,m$ical ,c\nt]measure ,innovation ,act ( #bjae2 & 7,d7 is = a human drug1 no active +r$i5t 7includ+ any e/] or salt ( ! active +r$i5t7 ( :i* has be5 approv$ 9 any o!r application "u section #eje7;b77#a7 or section #cea ( ! ,public ,heal? ,s]vice ,act4 7b7 ,priority review v\*] 7#a7 ,9 g5]al ,! ,secret>y %all aw>d a priority review v\*] to ! sponsor ( a mat]ial ?reat m$ical c\nt]measure application ^u approval by ! ,secret>y ( su* mat]ial ?reat m$ical c\nt]measure application4 7#b7 ,transf]ability ,! sponsor ( a mat]ial ?reat m$ical c\nt]measure application t receives a priority review v\*] "u ?is section may transf] 7includ+ by sale7 ! entitlem5t to su* v\*] to a sponsor ( a human drug = :i* an application "u section #eje7;b77#a7 or section #cea ( ! ,public ,heal? ,s]vice ,act w be submitt$ aft] ! date ( ! approval ( ! mat]ial ?reat m$ical c\nt]measure application4 ,!re is no limit on ! numb] ( times a priority review v\*] may be transf]r$ be=e su* v\*] is us$4 7#c7 ,notification 7,a7 ,9 g5]al ,! sponsor ( a human drug application %all notify ! ,secret>y n lat] ?an #ij cal5d> days prior to submission ( ! human drug application t is ! subject ( a priority review v\*] ( an int5t to submit ! human drug application1 includ+ ! date on :i* ! sponsor int5ds to submit ! application4 ,su* notification %all be a legally b9d+ commitm5t to pay = ! us] fee to be assess$ 9 accordance ) ?is section4 7,b7 ,transf] aft] notice ,! sponsor ( a human drug application t provides notification ( ! int5t ( su* sponsor to use ! v\*] = ! human drug application "u subp>agraph 7,a7 may transf] ! v\*] aft] su* notification is provid$1 if su* sponsor has n yet submitt$ ! human drug application describ$ 9 ! notification4 7c7 ,priority review us] fee 7#a7 ,9 g5]al ,! ,secret>y %all e/abli% a us] fee program "u :i* a sponsor ( a human drug application t is ! subject ( a priority review v\*] %all pay to ! ,secret>y a fee det]m9$ "u p>agraph 7#b74 ,su* fee %all be 9 addition to any fee requir$ to be submitt$ by ! sponsor "u *apt] ,,vii4 7#b7 ,fee am\nt ,! am\nt ( ! priority review us] fee %all be det]m9$ ea* fiscal ye> by ! ,secret>y & bas$ on ! av]age co/ incurr$ by ! ag5cy 9 ! review ( a human drug application subject to priority review 9 ! previ\s fiscal ye>4 7#c7 ,annual fee sett+ ,! ,secret>y %all e/abli%1 be=e ! beg9n+ ( ea* fiscal ye> beg9n+ aft] ,septemb] #cj1 #bjae1 = t fiscal ye>1 ! am\nt ( ! priority review us] fee4 7#d7 ,paym5t 7,a7 ,9 g5]al ,! priority review us] fee requir$ by ?is subsection %all be due ^u ! submission ( a human drug application "u section #eje7;b77#a7 or section #cea ( ! ,public ,heal? ,s]vice ,act = :i* ! priority review v\*] is us$4 7,b7 ,complete application ,an application describ$ "u subp>agraph 7,a7 = :i* ! sponsor reque/s ! use ( a priority review v\*] %all be consid]$ incomplete if ! fee requir$ by ?is subsection & all o!r applicable us] fees are n paid 9 accordance ) ! ,secret>y's proc$ures = pay+ su* fees4 7,c7 ,no waiv]s1 exemptions1 r$uctions1 or refunds ,! ,secret>y may n grant a waiv]1 exemption1 r$uction1 or refund ( any fees due & payable "u ?is section4 7#e7 ,(fsett+ collections ,fees collect$ pursuant to ?is subsection = any fiscal ye>-- 7,a7 %all be deposit$ & cr$it$ z (fsett+ collections to ! acc\nt provid+ appropriations to ! ,food & ,drug ,adm9i/ration2 & 7,b7 %all n be collect$ = any fiscal ye> except to ! ext5t provid$ 9 advance 9 appropriation ,acts4 7d7 ,notice ( ,issuance ( ,v\*] & ,approval ( ,products ,"u ,v\*] ,! ,secret>y %all publi% a notice 9 ! ,f$]al ,regi/] & on ! ,int]net ,website ( ! ,food & ,drug ,adm9i/ration n lat] ?an #cj cal5d> days aft] ! occurr5ce ( ea* ( ! foll[+3 7#a7 ,! ,secret>y issues a priority review v\*] "u ?is section4 7#b7 ,! ,secret>y approves a drug pursuant to an application submitt$ "u section #eje7;b7 ( ?is ,act or section #cea7;a7 ( ! ,public ,heal? ,s]vice ,act = :i* ! sponsor ( ! application us$ a priority review v\*] "u ?is section4 7e7 ,eligibility = o!r programs ,no?+ 9 ?is section precludes a sponsor :o seeks a priority review v\*] "u ?is section f p>ticipat+ 9 any o!r inc5tive program1 includ+ "u ?is ,act1 except t no sponsor ( a mat]ial ?reat m$ical c\nt]measure application may receive m ?an "o priority review v\*] ) respect to su* drug4 7f7 ,relation to o!r provisions ,! provisions ( ?is section %all supplem5t1 n supplant1 any o!r provisions ( ?is ,act or ! ,public ,heal? ,s]vice ,act t enc\rage ! developm5t ( m$ical c\nt]measures4 4 #a4 ,%ort title ,?is ,act may be cit$ z ! ,m$ical ,c\nt]measure ,innovation ,act ( #bjaf4 #b4 ,m$ical c\nt]measure guidel9es 7a7 ,/rategic national /ockpile & security c\nt]measure procurem5ts ,section #cai;,f-#b ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bdg;d-#f;b7 is am5d$-- 7#a7 9 subsection 7a71 by add+ at ! end ! foll[+3 7#c7 ,utilization guidel9es ,! ,secret>y %all ensure timely & accurate recomm5d$ utilization guidel9es = qualifi$ c\nt]measures 7z def9$ 9 section #cai;,f-#a71 qualifi$ p&emic & epidemic products 7z def9$ 9 section #cai;,f-#c71 & security c\nt]measures 7z def9$ 9 subsection 7c771 includ+ = su* products 9 ! /ockpile4 2 & 7#b7 9 subsection 7g7-- 7,a7 by am5d+ p>agraph 7#d7 to read z foll[s3 7#d7 ,report on security c\nt]measure procurem5t ,n lat] ?an ,m>* #a ( ea* ye> 9 :i* ! ,secret>y det]m9es t ! am\nt ( funds available = procurem5t ( security c\nt]measures is less ?an #a1ejj1jjj1jjj1 ! ,secret>y %all submit to ! ,committee on ,appropriations & ! ,committee on ,heal?1 ,education1 ,labor1 & ,p5sions ( ! ,s5ate & ! ,committee on ,appropriations & ! ,committee on ,en]gy & ,comm]ce ( ! ,h\se ( ,repres5tatives a report detail+ ! am\nt ( su* funds available = procurem5t & ! impact su* am\nt ( fund+ w h-- 7,a7 9 meet+ ! security c\nt]measure ne$s id5tifi$ "u ?is section2 & 7,b7 on ! annual ,public ,heal? ,em]g5cy ,m$ical ,c\nt]measures ,ent]prise & ,/rategy ,implem5tation ,plan 7pursuant to section #bhaa7;d774 2 & #c4 ,cl>ification on ,,b>da contract+ au?ority 7a7 ,9 g5]al ,section #cai;,f-#b7;g7 ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bdg;d-#f;b7g77 is am5d$ by add+ at ! end ! foll[+3 7#e7 ,cl>ification on contract+ au?ority ,! ,secret>y1 act+ ?r\gh ! ,director ( ! ,biom$ical ,advanc$ ,rese>* & ,developm5t ,au?ority1 %all c>ry out ! programs fund$ by ! special res]ve fund 7= ! procurem5t ( security c\nt]measures "u subsection 7c7 & = c>ry+ out section #cai,l71 includ+ ! execution ( procurem5t contracts1 grants1 & coop]ative agreem5ts pursuant to ?is section & section #cai,l4 4 7b7 ,,b>da contract+ au?ority ,section #cai,l7c77#c7 ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bdg;d-#g;c7 is am5d$ by ins]t+ 1 includ+ ! execution ( procurem5t contracts1 grants1 & coop]ative agreem5ts pursuant to ?is section be=e ! p]iod4 #d4 ,c\nt]measures budget plan ,section #bhaa7;b77#g7 ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #cjj;hh-#aj7;b77#g77 is am5d$-- 7#a7 by /rik+ ! fir/ s5t5ce & ins]t+ ,develop1 & update n lat] ?an ,m>* #a ( ea* ye>1 a coord9at$ #e-ye> budget plan bas$ on ! m$ical c\nt]measure priorities describ$ 9 subsection 7d71 includ+ ) respect to *emical1 biological1 radiological1 & nucle> ag5t or ag5ts t may pres5t a ?reat to ! ,nation1 includ+ su* ag5ts t are novel or em]g+ infecti\s diseases1 & ! correspond+ ef=ts to develop qualifi$ c\nt]measures 7z def9$ 9 section #cai;,f-#a71 security c\nt]measures 7z def9$ 9 section #cai;,f-#b71 & qualifi$ p&emic or epidemic products 7z def9$ 9 section #cai;,f-#c7 = ea* su* ?reat42 7#b7 9 subp>agraph 7,c71 by /rik+ 2 & & ins]t+ a semicolon2 7#c7 9 subp>agraph 7,d71 by /rik+ to ! appropriate committees ( ,congress ^u reque/4 & ins]t+ 1 n lat] ?an ,m>* #ae ( ea* ye>1 to ! ,committee on ,appropriations & ! ,committee on ,heal?1 ,education1 ,labor1 & ,p5sions ( ! ,s5ate & ! ,committee on ,appropriations & ! ,committee on ,en]gy & ,comm]ce ( ! ,h\se ( ,repres5tatives2 &2 & 7#d7 by add+ at ! end ! foll[+3 7,e7 n lat] ?an ,m>* #ae ( ea* ye>1 be made publicly available 9 a mann] t does n compromise national security4 4 #e4 ,m$ical c\nt]measures innovation ,section #cai,l7c77#d7 ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bdg;d-#g;e7c77#d77 is am5d$ by add+ at ! end ! foll[+3 7,e7 ,m$ical c\nt]measures innovation p>tn] 7i7 ,9 g5]al ,to support ! purposes describ$ 9 p>agraph 7#b71 ! ,secret>y1 act+ ?r\gh ! ,director ( ,,b>da1 may ent] into an agreem5t 7includ+ ?r\gh ! use ( grants1 contracts1 coop]ative agreem5ts1 or o!r transactions z describ$ 9 p>agraph 7#e77 ) an indep5d5t1 non-pr(it entity to-- 7,i7 fo/] & accel]ate ! developm5t & innovation ( m$ical c\nt]measures & te*nologies t may assi/ advanc$ rese>* & developm5t ( qualifi$ c\nt]measures & qualifi$ p&emic or epidemic products1 includ+ ?r\gh ! use ( /rategic v5ture capital practices & me?ods2 7,,ii7 promote ! developm5t ( new & promis+ te*nologies t address urg5t m$ical c\nt]measure ne$s1 z id5tifi$ by ! ,secret>y2 7,,iii7 address unmet public heal? ne$s t are directly relat$ to m$ical c\nt]measure requirem5ts1 su* z novel antimicrobials = multidrug resi/ant organisms & multiuse plat=m te*nologies = diagno/ics1 prophylaxis1 vacc9es1 & !rapeutics2 & 7,,iv7 provide exp]t consultation & advice to fo/] viable m$ical c\nt]measure innovators1 includ+ help+ qualifi$ c\nt]measure innovators navigate unique indu/ry *all5ges ) respect to develop+ *emical1 biological1 radiological1 & nucle> c\nt]measure products4 7ii7 ,eligibility 7,i7 ,9 g5]al ,to be eligible to ent] into an agreem5t "u clause 7i7 an entity %all-- 7aa7 be an indep5d5t1 non-pr(it entity2 7bb7 h a demon/rat$ record ( be+ able to create l9kages betwe5 innovators & inve/ors & lev]age su* p>tn]%ips & res\rces = ! purpose ( address+ id5tifi$ /rategic ne$s ( ! ,f$]al ,gov]nm5t2 7cc7 h exp]i5ce 9 promot+ novel te*nology innovation2 7dd7 be problem driv5 & solution focus$ bas$ on ! ne$s1 requirem5ts1 & problems id5tifi$ by ! ,secret>y "u clause 7iv72 7ee7 demon/rate ! ability1 or ! pot5tial ability1 to promote ! developm5t ( m$ical c\nt]measure products2 7ff7 demon/rate exp]tise1 or ! capacity to develop or acquire exp]tise1 relat$ to te*nical & regulatory consid]ations ) respect to m$ical c\nt]measures2 & 7gg7 n be )9 ! ,dep>tm5t ( ,heal? & ,human ,s]vices4 7,,ii7 ,p>tn]+ exp]i5ce ,9 select+ an entity ) :i* to ent] into an agreem5t "u clause 7i71 ! ,secret>y %all place a high value on ! demon/rat$ exp]i5ce ( ! entity 9 p>tn]+ ) ! ,f$]al ,gov]nm5t to meet id5tifi$ /rategic ne$s4 7iii7 ,n ag5cy ,an entity t ent]s into an agreem5t "u clause 7i7 %all n be deem$ to be a ,f$]al ag5cy = any purpose1 includ+ = any purpose "u title #e1 ,unit$ ,/ates ,code4 7iv7 ,direction ,pursuant to an agreem5t ent]$ into "u ?is subp>agraph1 ! ,secret>y1 act+ ?r\gh ! ,director ( ,,b>da1 %all provide direction to ! entity t ent]s into an agreem5t "u clause 7i74 ,z "p ( ?is agreem5t ! ,director ( ,,b>da %all-- 7,i7 communicate ! m$ical c\nt]measure ne$s1 requirem5ts1 & problems to be address$ by ! entity "u ! agreem5t2 7,,ii7 develop a description ( "w to be p]=m$ by ! entity "u ! agreem5t2 7,,iii7 provide te*nical fe$back & appropriate ov]sight ov] "w c>ri$ out by ! entity "u ! agreem5t1 includ+ subsequ5t developm5t & p>tn]%ips consi/5t ) ! ne$s & requirem5ts set =? 9 ?is subp>agraph2 7,,iv7 ensure fair consid]ation ( products develop$ "u ! agreem5t 9 ord] to ma9ta9 competition to ! maximum practical ext5t1 z applicable & appropriate "u applicable provisions ( ?is section2 & 7,v7 ensure1 z a condition ( ! agreem5t-- 7aa7 a compreh5sive set ( policies t demon/rate a commitm5t to transp>5cy & acc\ntability2 7bb7 protection aga9/ conflicts ( int]e/ ?r\gh a compreh5sive set ( policies t address pot5tial conflicts ( int]e/1 e?ics1 disclosure1 & report+ requirem5ts2 7cc7 t ! entity provides mon?ly acc\nt+ on ! use ( funds provid$ "u su* agreem5t2 & 7dd7 t ! entity provides on a qu>t]ly basis1 reports reg>d+ ! progress made t[>d meet+ ! id5tifi$ ne$s set =? 9 ! agreem5t4 7v7 ,supplem5t n supplant ,activities c>ri$ out "u ?is subp>agraph %all supplem5t1 & n supplant1 o!r activities c>ri$ out "u ?is section4 7vi7 ,no e/abli%m5t ( entity ,to prev5t unnecess>y duplication & t>get res\rces effectively1 no?+ 9 ?is subp>agraph %all be con/ru$ to au?orize ! ,secret>y to e/abli% )9 ! ,dep>tm5t ( ,heal? & ,human ,s]vices an entity = ! purposes ( c>ry+ out ?is subp>agraph4 7vii7 ,transp>5cy & ov]sight ,^u reque/1 ! ,secret>y %all provide to ,congress ! in=mation provid$ to ! ,secret>y "u clause 7iv77,v77dd74 7viii7 ,indep5d5t evaluation ,n lat] ?an #d ye>s aft] ! date ( enactm5t ( ?is subp>agraph1 ! ,gov]nm5t ,acc\ntability ,(fice %all conduct an indep5d5t evaluation1 & submit to ! ,secret>y & ! appropriate committees ( ,congress a report1 conc]n+ ! activities conduct$ "u ?is subp>agraph4 ,su* report %all include recomm5dations ) respect to any agreem5t or activities c>ri$ out pursuant to ?is subp>agraph4 7ix7 ,sunset ,?is subp>agraph %all h no =ce or effect aft] ,septemb] #cj1 #bjbb4 4 #f4 ,/reaml9+ ! project bio%ield procurem5t process ,section #cai;,f-#b7;c7 ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bdg;d-#f;b7c77 is am5d$-- 7#a7 9 p>agraph 7#d77;,a77ii71 by /rik+ make a recomm5dation "u p>agraph 7#f7 t ! special res]ve fund z def9$ 9 subsection 7h7 be made available = ! procurem5t ( su* c\nt]measure & ins]t+ & subject to ! availability ( appropriations1 make available ! special res]ve fund z def9$ 9 subsection 7h7 = procurem5t ( su* c\nt]measure1 z applicable2 7#b7 9 p>agraph 7#f7-- 7,a7 by /rik+ subp>agraphs 7,a71 7,b71 & 7,e72 7,b7 by r$esignat+ subp>agraphs 7,c7 & 7,d7 z subp>agraphs 7,a7 & 7,b71 respectively2 7,c7 by am5d+ subp>agraph 7,a71 z s r$esignat$1 to read z foll[s3 7,a7 ,notice to appropriate congressional committees ,! ,secret>y %all notify ! ,committee on ,appropriations & ! ,committee on ,heal?1 ,education1 ,labor1 & ,p5sions ( ! ,s5ate & ! ,committee on ,appropriations & ! ,committee on ,en]gy & ,comm]ce ( ! ,h\se ( ,repres5tatives ( ea* decision to make available ! special res]ve fund z def9$ 9 subsection 7h7 = procurem5t ( a security c\nt]measure1 includ+1 :]e available1 ! numb] (1 ! nature (1 & o!r in=mation conc]n+ pot5tial suppli]s ( su* c\nt]measure1 & :e!r o!r pot5tial suppli]s ( ! same or simil> c\nt]measures 7 consid]$ & reject$ = procurem5t "u ?is section & ! reasons !re=e4 2 & 7,d7 9 ! head+1 by /rik+ ,recomm5dation = presid5t's approval & ins]t+ ,recomm5dations = procurem5t2 & 7#c7 9 p>agraph 7#g7-- 7,a7 by /rik+ subp>agraph 7,a72 7,b7 by /rik+ subp>agraph 7,b7 & ins]t+ ! foll[+3 7,a7 ,paym5ts f special res]ve fund ,! special res]ve fund z def9$ 9 subsection 7h7 %all be available = paym5ts made by ! ,secret>y to a v5dor = procurem5t ( a security c\nt]measure 9 accordance ) ! provisions ( ?is p>agraph4 2 & 7,c7 by r$esignat+ subp>agraph 7,c7 z subp>agraph 7,b74 #g4 ,priority review to enc\rage treatm5ts = ag5ts t pres5t national security ?reats ,sub*apt] ,e ( *apt] ,v ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;bbb et seq47 is am5d$ by ins]t+ aft] section #efe ! foll[+3 #efe;,a4 ,priority review to enc\rage treatm5ts = ag5ts t pres5t national security ?reats 7a7 ,def9itions ,9 ?is section3 7#a7 ,! t]m priority review ) respect to a human drug application z def9$ 9 section #gce7a71 means review & action by ! ,secret>y on su* application n lat] ?an #f mon?s aft] receipt by ! ,secret>y ( su* application1 z describ$ 9 ! ,manual ( ,policies & ,proc$ures 9 ! ,food & ,drug ,adm9i/ration & goals id5tifi$ 9 ! lett]s describ$ 9 section #aja7;b7 ( ! ,food & ,drug ,adm9i/ration ,safety & ,innovation ,act4 7#b7 ,priority review v\*] ,! t]m priority review v\*] means a v\*] issu$ by ! ,secret>y to ! sponsor ( a mat]ial ?reat m$ical c\nt]measure application t entitles ! hold] ( su* v\*] to priority review ( a s+le human drug application submitt$ "u section #eje7;b77#a7 or section #cea7;a7 ( ! ,public ,heal? ,s]vice ,act aft] ! date ( approval ( ! mat]ial ?reat m$ical c\nt]measure application4 7#c7 ,mat]ial ?reat m$ical c\nt]measure application ,! t]m mat]ial ?reat m$ical c\nt]measure application means an application t-- 7,a7 is a human drug application z def9$ 9 section #gce7a7-- 7i7 to prev5t1 or treat h>m f a biological1 *emical1 radiological1 or nucle> ag5t id5tifi$ z a mat]ial ?reat "u section #cai;,f-#b7;c77#b77;,a77ii7 ( ! ,public ,heal? ,s]vice ,act1 or 7ii7 to mitigate1 prev5t1 or treat h>m f a condition t may result 9 adv]se heal? consequ5ces or dea? & may be caus$ by adm9i/]+ a drug1 or biological product aga9/ su* ag5t2 & 7,b7 ! ,secret>y deems eligible = priority review2 7,c7 is approv$ aft] ! date ( enactm5t ( ! ,m$ical ,c\nt]measure ,innovation ,act ( #bjaf2 & 7,d7 is = a human drug1 no active +r$i5t 7includ+ any e/] or salt ( ! active +r$i5t7 ( :i* has be5 approv$ 9 any o!r application "u section #eje7;b77#a7 or section #cea7;a7 ( ! ,public ,heal? ,s]vice ,act4 7b7 ,priority review v\*] 7#a7 ,9 g5]al ,! ,secret>y %all aw>d a priority review v\*] to ! sponsor ( a mat]ial ?reat m$ical c\nt]measure application ^u approval by ! ,secret>y ( su* mat]ial ?reat m$ical c\nt]measure application4 7#b7 ,transf]ability ,! sponsor ( a mat]ial ?reat m$ical c\nt]measure application t receives a priority review v\*] "u ?is section may transf] 7includ+ by sale7 ! entitlem5t to su* v\*] to a sponsor ( a human drug = :i* an application "u section #eje7;b77#a7 or section #cea7;a7 ( ! ,public ,heal? ,s]vice ,act w be submitt$ aft] ! date ( ! approval ( ! mat]ial ?reat m$ical c\nt]measure application4 ,!re is no limit on ! numb] ( times a priority review v\*] may be transf]r$ be=e su* v\*] is us$4 7#c7 ,notification 7,a7 ,9 g5]al ,! sponsor ( a human drug application %all notify ! ,secret>y n lat] ?an #ij cal5d> days prior to submission ( ! human drug application t is ! subject ( a priority review v\*] ( an int5t to submit ! human drug application1 includ+ ! date on :i* ! sponsor int5ds to submit ! application4 ,su* notification %all be a legally b9d+ commitm5t to pay = ! us] fee to be assess$ 9 accordance ) ?is section4 7,b7 ,transf] aft] notice ,! sponsor ( a human drug application t provides notification ( ! int5t ( su* sponsor to use ! v\*] = ! human drug application "u subp>agraph 7,a7 may transf] ! v\*] aft] su* notification is provid$1 if su* sponsor has n yet submitt$ ! human drug application describ$ 9 ! notification4 7c7 ,priority review us] fee 7#a7 ,9 g5]al ,! ,secret>y %all e/abli% a us] fee program "u :i* a sponsor ( a human drug application t is ! subject ( a priority review v\*] %all pay to ! ,secret>y a fee det]m9$ "u p>agraph 7#b74 ,su* fee %all be 9 addition to any fee requir$ to be submitt$ by ! sponsor "u *apt] ,,vii4 7#b7 ,fee am\nt ,! am\nt ( ! priority review us] fee %all be det]m9$ ea* fiscal ye> by ! ,secret>y & bas$ on ! av]age co/ incurr$ by ! ag5cy 9 ! review ( a human drug application subject to priority review 9 ! previ\s fiscal ye>4 7#c7 ,annual fee sett+ ,! ,secret>y %all e/abli%1 be=e ! beg9n+ ( ea* fiscal ye> beg9n+ aft] ,septemb] #cj1 #bjae1 = t fiscal ye>1 ! am\nt ( ! priority review us] fee4 7#d7 ,paym5t 7,a7 ,9 g5]al ,! priority review us] fee requir$ by ?is subsection %all be due ^u ! submission ( a human drug application "u section #eje7;b77#a7 or section #cea7;a7 ( ! ,public ,heal? ,s]vices ,act = :i* ! priority review v\*] is us$4 7,b7 ,complete application ,an application describ$ "u subp>agraph 7,a7 = :i* ! sponsor reque/s ! use ( a priority review v\*] %all be consid]$ incomplete if ! fee requir$ by ?is subsection & all o!r applicable us] fees are n paid 9 accordance ) ! ,secret>y's proc$ures = pay+ su* fees4 7,c7 ,no waiv]s1 exemptions1 r$uctions1 or refunds ,! ,secret>y may n grant a waiv]1 exemption1 r$uction1 or refund ( any fees due & payable "u ?is section4 7#e7 ,(fsett+ collections ,fees collect$ pursuant to ?is subsection = any fiscal ye>-- 7,a7 %all be deposit$ & cr$it$ z (fsett+ collections to ! acc\nt provid+ appropriations to ! ,food & ,drug ,adm9i/ration2 & 7#f7 %all n be collect$ = any fiscal ye> except to ! ext5t provid$ 9 advance 9 appropriation ,acts4 7d7 ,notice ( ,issuance ( ,v\*] & ,approval ( ,products ,"u ,v\*] ,! ,secret>y %all publi% a notice 9 ! ,f$]al ,regi/] & on ! ,int]net ,website ( ! ,food & ,drug ,adm9i/ration n lat] ?an #cj cal5d> days aft] ! occurr5ce ( ea* ( ! foll[+3 7#a7 ,! ,secret>y issues a priority review v\*] "u ?is section4 7#b7 ,! ,secret>y approves a drug pursuant to an application submitt$ "u section #eje7;b7 ( ?is ,act or section #cea7;a7 ( ! ,public ,heal? ,s]vice ,act = :i* ! sponsor ( ! application us$ a priority review v\*] "u ?is section4 7e7 ,eligibility = o!r programs ,no?+ 9 ?is section precludes a sponsor :o seeks a priority review v\*] "u ?is section f p>ticipat+ 9 any o!r inc5tive program1 includ+ "u ?is ,act1 except t no sponsor ( a mat]ial ?reat m$ical c\nt]measure application may receive m ?an "o priority review v\*] issu$ "u any section ( ?is ,act ) respect to su* drug4 7f7 ,relation to o!r provisions ,! provisions ( ?is section %all supplem5t1 n supplant1 any o!r provisions ( ?is ,act or ! ,public ,heal? ,s]vice ,act t enc\rage ! developm5t ( m$ical c\nt]measures4 4 #h4 ,,gao report 7a7 ,/udy ,! ,comptroll] ,g5]al ( ! ,unit$ ,/ates %all conduct a /udy on ! effectiv5ess ( priority review v\*]s "u section #efe;,a ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7z add$ by section #g7 9 provid+ inc5tives = ! developm5t ( mat]ial ?reat m$ical c\nt]measures applications "u su* section #efe;,a4 ,9 conduct+ su* /udy1 ! ,comptroll] ,g5]al %all exam9e ! foll[+3 7#a7 ,! impact ( ! priority review v\*] 9 attract+ inve/m5t into ! developm5t ( mat]ial ?reat m$ical c\nt]measures & ! impact ( su* inve/m5t1 z applicable1 on ! developm5t ( su* c\nt]measures4 7#b7 ,h[ ! drugs = :i* priority review v\*]s 7 aw>d$ "u su* section #efe;,a-- 7,a7 address$ id5tifi$ m$ical c\nt]measure ne$s2 & 7,b7 impact$ ,unit$ ,/ates prep>$ness aga9/ *emical1 biological1 radiological1 & nucle> ?reats1 includ+ bo? id5tifi$ ?reats & naturally-occurr+ ?reats4 7#c7 ,h[ _m mat]ial ?reat m$ical c\nt]measures 7 lic5s$ or approv$1 or o!rwise significantly advanc$ 9 cl9ical developm5t1 9 ! #aj ye>s foll[+ ! enactm5t ( su* section #efe;,a comp>$ to ! #aj ye>s prior to ! enactm5t ( su* section4 7#d7 ,an analysis ( ! drugs = :i* su* priority review v\*]s 7 us$1 :i* %all include-- 7,a7 ! indications = :i* su* drugs 7 approv$ "u section #eje7;b77#a7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cee7 or section #cea7;a7 ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bfb72 7,b7 :e!r unmet m$ical ne$s 7 address$ ?r\gh ! approval ( su* drugs1 includ+1 = ea* su* drug-- 7i7 if an alt]native !rapy 0 previ\sly available to treat ! indication2 & 7ii7 if ! drug provid$ a b5efit or advantage ov] ano!r available !rapy2 7,c7 ! value ( ! priority review v\*] if transf]r$2 & 7,d7 ! l5g? ( "t betwe5 ! date on :i* a priority review v\*] 0 aw>d$ & ! date on :i* x 0 us$4 7#e7 ,) respect to ! priority review v\*] program "u su* section #efe;,a-- 7,a7 h[ _m priority review v\*]s 7 aw>d$ "u su* section #efe;,a & h[ _m ( su* aw>d$ v\*]s 7 r$eem$ = priority review ( a drug application 9 ! #aj ye>s foll[+ ! date ( enactm5t ( su* section2 7,b7 ! res\rces associat$ ) ! ,food & ,drug ,adm9i/ration implem5tation ( su* section #efe;,a & review ( applications = :i* a v\*] aw>d$ "u su* section #efe;,a is r$eem$ = priority review2 & 7,c7 recomm5dations1 if any1 ) respect to h[ su* section #efe;,a c\ld be improv$ to bett] a*ieve ! objective ( inc5tiviz+ ! timely developm5t ( m$ical c\nt]measures to address id5tifi$ *emical1 biological1 radiological1 & nucle> ?reats1 includ+ = m$ical c\nt]measures t might o!rwise n be develop$1 pot5tially eligible = an em]g5cy use au?orization1 lic5s$1 or approv$4 7b7 ,consultations ,9 conduct+ ! /udy "u subsection 7a71 ! ,comptroll] ,g5]al ( ! ,unit$ ,/ates %all consult )-- 7#a7 drug manufactur]s involv$ 9 ! rese>* & developm5t ( m$ical c\nt]measures to address biological1 *emical1 radiological1 & nucle> ?reats2 7#b7 /akehold]s involv$ 9 inve/+ 9 ! rese>* & developm5t ( m$ical c\nt]measures1 includ+ v5ture capitali/s2 7#c7 ! ,f$]al ,gov]nm5t ag5cies responsible = advanc+1 review+1 & procur+ m$ical c\nt]measures1 includ+-- 7,a7 ! ,dep>tm5t ( ,heal? & ,human ,s]vices1 includ+ ! ,(fice ( ! ,assi/ant ,secret>y = ,prep>$ness & ,response1 ! ,biom$ical ,advanc$ ,rese>* & ,developm5t ,au?ority1 & ! ,food & ,drug ,adm9i/ration2 & 7,b7 ! ,dep>tm5t ( ,def5se2 & 7#d7 biodef5se /akehold]s1 z applicable4 7c7 ,initial assessm5t ,n lat] ?an #g ye>s aft] ! date ( enactm5t ( ?is ,act1 ! ,comptroll] ,g5]al ( ! ,unit$ ,/ates %all submit to ! ,committee on ,heal?1 ,education1 ,labor1 & ,p5sions ( ! ,s5ate & ! ,committee on ,en]gy & ,comm]ce ( ! ,h\se ( ,repres5tatives an initial assessm5t ( ! effectiv5ess ( ! priority review v\*] program set =? 9 section #efe;,a ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7z add$ by section #g74 7d7 ,report ,n lat] ?an #ab ye>s aft] ! date ( enactm5t ( ?is ,act1 ! ,comptroll] ,g5]al ( ! ,unit$ ,/ates %all submit to ! ,committee on ,heal?1 ,education1 ,labor1 & ,p5sions ( ! ,s5ate & ! ,committee on ,en]gy & ,comm]ce ( ! ,h\se ( ,repres5tatives a report conta9+ ! results ( ! /udy conduct$ "u subsection 7a74 7e7 ,protection ( national security ,! ,comptroll] ,g5]al ( ! ,unit$ ,/ates %all conduct ! /udy & issue ! assessm5t & report "u ?is section 9 a mann] t does n compromise national security4 ,m>* #ad1 #bjaf,report$ ) an am5dm5t