,i #aad? ,,congress #a/ ,session ,h4 ,r4 #ghf ,,9 ,,! ,,h\se ,,( ,,repres5tatives ,febru>y #e1 #bjae ,mrs4 ,ellm]s 7= h]self & ,mr4 ,butt]field7 introduc$ ! foll[+ bill2 :i* 0 ref]r$ to ! ,committee on ,en]gy & ,comm]ce1 & 9 addition to ! ,committee on ,ways & ,means1 = a p]iod to be subsequ5tly det]m9$ by ! ,speak]1 9 ea* case = consid]ation ( su* provisions z fall )9 ! jurisdiction ( ! committee conc]n$ ,a ,,bill ,to improve access1 c]ta9ty1 & innovation ) respect to vacc9es4 #a4 ,%ort title ,?is ,act may be cit$ z ! ,vacc9e ,access1 ,c]ta9ty1 & ,innovation ,act ( #bjae4 #b4 ,table ( cont5ts ,! table ( cont5ts = ?is ,act is z foll[s3 ,sec4 #a4 ,%ort title4 ,sec4 #b4 ,table ( cont5ts4 ,title ,i--,developm5t1 ,lic5sure1 & ,recomm5dations ,sec4 #aja4 ,review ( transp>5cy & consi/5cy ( ,,acip recomm5dation process4 ,sec4 #ajb4 ,guidance on vacc9e developm5t4 ,sec4 #ajc4 ,meet+s betwe5 ,,cdc & vacc9e develop]s4 ,sec4 #ajd4 ,modifications to priority review v\*] program = tropical diseases4 ,sec4 #aje4 ,guidance on *anges to an approv$ application = biological products4 ,sec4 #ajf4 ,exp$it+ ! process = export c]tifications = vacc9es4 ,sec4 #ajg4 ,,nih vacc9e rese>*4 ,title ,,ii--,m$ic>e1 ,m$icaid1 & o!r provisions ,sec4 #bja4 ,requir+ prompt updates to ,m$ic>e program ^u issuance ( ,,acip recomm5dations4 ,sec4 #bjb4 ,,gao /udy & report on ,m$ic>e & ,m$icaid b5efici>y access = vacc9es4 ,sec4 #bjc4 ,enc\rag+ heal? plans to e/abli% programs to increase adult immunization4 ,i ,developm5t1 ,lic5sure1 & ,recomm5dations #aja4 ,review ( transp>5cy & consi/5cy ( ,,acip recomm5dation process 7a7 ,review ,! ,director ( ! ,c5t]s = ,disease ,control & ,prev5tion %all conduct a review ( ! transp>5cy & consi/5cy ( ! process us$ by ! ,advisory ,committee on ,immunization ,practices 9 =mulat+ & issu+ recomm5dations p]ta9+ to vacc9es4 7b7 ,consid]ations ,! review "u subsection 7a7 %all include assessm5t (-- 7#a7 ! crit]ia us$ to evaluate new & exi/+ vacc9es2 7#b7 ! ,grad+ ( ,recomm5dations1 ,assessm5t1 ,developm5t1 & ,evaluation 7,,grade7 approa* to ! review & analysis ( sci5tific & economic data1 includ+ ! sci5tific basis = su* approa*2 & 7#c7 ! ext5t to :i* ! processes us$ by ! work+ gr\ps ( ! ,advisory ,committee on ,immunization ,practices are transp>5t & consi/5t4 7c7 ,/akehold]s ,9 c>ry+ out ! review "u subsection 7a71 ! ,director ( ! ,c5t]s = ,disease ,control & ,prev5tion %all solicit input f vacc9e /akehold]s4 7d7 ,report ,n lat] ?an #a ye> aft] ! date ( enactm5t ( ?is ,act1 ! ,director ( ! ,c5t]s = ,disease ,control & ,prev5tion %all submit to ! appropriate committees ( ! ,congress & make publicly available a report on ! results ( ! review "u subsection 7a71 includ+ recomm5dations on improv+ ! transp>5cy & consi/5cy ( ! process describ$ 9 su* subsection4 7e7 ,def9ition ,9 ?is section1 ! t]m ,advisory ,committee on ,immunization ,practices means ! advisory committee on immunization practices e/abli%$ by ! ,secret>y ( ,heal? & ,human ,s]vices pursuant to section #bbb ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bag;a71 act+ ?r\gh ! ,director ( ! ,c5t]s = ,disease ,control & ,prev5tion4 #ajb4 ,guidance on vacc9e developm5t 7a7 ,issuance ,n lat] ?an #b ye>s aft] ! date ( enactm5t ( ?is ,act1 ! ,secret>y ( ,heal? & ,human ,s]vices %all issue f9al guidance to facilitate ! use ( accel]at$ & exp$it$ pa?ways = ! developm5t & lic5sure ( vacc9es to prev5t-- 7#a7 em]g+1 re-em]g+1 or r>e infecti\s diseases ) respect to :i* ! l[ preval5ce or nature ( ! disease may r5d] ! exi/5ce or collection ( cl9ical outcome data unlikely or impractical2 & 7#b7 infecti\s diseases ) respect to :i* curr5tly available vacc9es are n address+ ! full scope ( public heal? ne$s4 7b7 ,consid]ations ,9 develop+ ! guidance requir$ by ?is section1 ! ,secret>y ( ,heal? & ,human ,s]vices %all consid] issues relat+ to cl9ical developm5t /rategies = diseases describ$ 9 subsection 7a71 includ+ ! developm5t & acceptability ( novel cl9ical & surrogate endpo9ts1 ! use ( novel or accel]at$ /udy designs1 ! use ( obs]vational real-_w data1 ! use ( novel adjuvants1 ! use ( new te*nologies or approa*es to collect+ & monitor+ pati5t-level data1 & ! demon/ration ( efficacy ?r\gh /udies 9 heal?y volunte]s = ! purpose ( lic5sure4 #ajc4 ,meet+s betwe5 ,,cdc & vacc9e develop]s ,section #caj ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bdbo7 is am5d$ by add+ at ! end ! foll[+3 7c7 7#a7 ,9 ?is subsection1 ! t]m vacc9e develop] means a nongov]nm5tal entity engag$ 9-- 7,a7 ! developm5t or production ( a vacc9e2 & 7,b7 vacc9e rese>*4 7#b7 7,a7 ,^u ! submission ( a writt5 reque/ by a vacc9e develop]1 ! ,secret>y1 act+ ?r\gh ! ,director ( ! ,c5t]s = ,disease ,control & ,prev5tion1 %all conv5e a meet+ ( repres5tatives ( ! vacc9e develop] & exp]ts 9 immunization programs1 epidemiology1 & o!r relevant areas1 includ+ su* exp]ts f ! ,food & ,drug ,adm9i/ration & ! ,national ,vacc9e ,program1 at :i* ! ,director 7or ! ,director's designee71 = ! purpose ( in=m+ ! vacc9e develop]'s und]/&+ ( public heal? ne$s & priorities1 %all provide ! p]spectives ( ! ,c5t]s = ,disease ,control & ,prev5tion & o!r relevant ,f$]al ag5cies reg>d+-- 7i7 public heal? ne$s1 epidemiology1 & implem5tation consid]ations ) reg>d to a vacc9e develop]'s pot5tial vacc9e pr(ile2 & 7ii7 pot5tial implications ( su* p]spectives = ! vacc9e develop]'s vacc9e rese>* & developm5t plann+4 7,b7 ,! ,director ( ! ,c5t]s = ,disease ,control & ,prev5tion 7or ! ,director's designee7 %all conv5e a meet+ reque/$ "u subp>agraph 7,a7 n lat] ?an #ij bus9ess days aft] receipt ( ! reque/ = ! meet+4 7#c7 7,a7 ,^u ! submission ( a writt5 reque/ by a vacc9e develop]1 ! ,secret>y1 act+ ?r\gh ! ,director ( ! ,c5t]s = ,disease ,control & ,prev5tion1 %all provide to ! vacc9e develop] any age-bas$ disease epidemiological analyses or data t-- 7i7 are specifi$ 9 ! reque/2 7ii7 h be5 publi%$2 7iii7 h be5 p]=m$ by or are 9 ! possession ( ! ,c5t]s2 & 7iv7 are n a trade secret or o!rwise confid5tial in=mation subject to section #eeb7;b77#d7 ( title #e1 ,unit$ ,/ates ,code1 or section #aije ( title #ah1 ,unit$ ,/ates ,code4 7,b7 ,! ,secret>y %all provide analyses reque/$ by a vacc9e manufactur] "u subp>agraph 7,a7 n lat] ?an #ij bus9ess days aft] receipt ( ! reque/ = ! analyses4 7#d7 ,! ,secret>y %all promptly notify a vacc9e develop] if-- 7,a7 ! ,secret>y becomes aw>e ( any *ange to in=mation t 0-- 7i7 %>$ by ! ,secret>y ) ! vacc9e develop] dur+ a meet+ "u p>agraph 7#b72 or 7ii7 provid$ by ! ,secret>y to ! vacc9e develop] 9 "o or m analyses "u p>agraph 7#c72 & 7,b7 ! *ange may h implications = ! vacc9e develop]'s vacc9e rese>* & developm5t4 4 #ajd4 ,modifications to priority review v\*] program = tropical diseases ,section #ebd ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cfjn7 is am5d$-- 7#a7 9 subsection 7a7-- 7,a7 9 p>agraph 7#c7-- 7i7 9 ! matt] be=e subp>agraph 7,a71 by /rik+ ,?is t]m & ins]t+ ,9 ?is section1 ?is t]m2 & 7ii7 9 subp>agraph 7,r71 by /rik+ designat$ by ord] ( ! ,secret>y & ins]t+ designat$ by ! ,secret>y pursuant to p>agraph 7#d72 7,b7 by r$esignat+ p>agraph 7#d7 z p>agraph 7#e72 & 7,c7 by ins]t+ aft] p>agraph 7#c7 ! foll[+3 7#d7 ,designation ( o!r infecti\s diseases z tropical diseases 7,a7 ,9 g5]al ,! ,secret>y %all e/abli% a process "u :i* ! ,secret>y-- 7i7 us+ a me?odology t is made available to ! public on ! ,int]net site ( ! ,food & ,drug ,adm9i/ration1 designates infecti\s diseases o!r ?an ! diseases specifi$ 9 subp>agraphs 7,a7 ?r\gh 7,q7 ( p>agraph 7#c7 to be tropical diseases = purposes ( ?is section2 & 7ii7 publi%es on su* ,int]net site a complete1 updat$ li/ ( ! diseases t are tropical diseases = purposes ( ?is section4 7,b7 ,consid]ations ,9 designat+ an infecti\s disease z a tropical disease "u subp>agraph 7,a71 ! ,secret>y %all-- 7i7 consid] ! pot5tial impact ( ! disease on ! public heal? due to-- 7,i7 ! pot5tial rate ( spread ( ! disease2 & 7,,ii7 ! pot5tial sev]ity ( ! disease 9 t]ms ( human morbidity & mortality2 & 7ii7 consult ) exp]ts 9 tropical infecti\s diseases1 includ+ ! ,c5t]s = ,disease ,control & ,prev5tion1 ! ,food & ,drug ,adm9i/ration1 m$ical pr(essionals1 ! cl9ical rese>* community1 & ! ,_w ,heal? ,organization4 7,c7 ,review ,e #e ye>s1 or m frequ5tly z det]m9$ necess>y by ! ,secret>y1 ! ,secret>y %all review1 provide modifications to1 & re-publi% ! li/ publi%$ "u subp>agraph 7,a7 & any revisions made to ! me?odology = designation ( diseases "u su* subp>agraph4 2 7#b7 9 subsection 7b7-- 7,a7 9 p>agraph 7#b71 by /rik+ ,! sponsor ( a tropical disease & ins]t+3 7,a7 ,9 g5]al ,! sponsor ( a tropical disease 2 7,b7 by ins]t+ aft] su* p>agraph 7#b77;,a7 ! foll[+3 7,b7 ,notification ( transf] ,ea* p]son to :om a priority review v\*] is transf]r$ %all notify ! ,secret>y ( su* *ange 9 own]%ip ( ! v\*] n lat] ?an #cj bus9ess days aft] su* transf]4 2 7,c7 9 p>agraph 7#d71 by /rik+ ,! sponsor ( a human drug application & ins]t+3 7,a7 ,9 g5]al ,! sponsor ( a human drug application 2 & 7,d7 by ins]t+ aft] p>agraph 7#d77;,a71 z designat$ by subp>agraph 7,d71 ! foll[+3 7,b7 ,transf] aft] notice ,! sponsor ( a human drug application t provides notification ( int5t "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 ,^u su* a transf]1 not)/&+ subp>agraph 7,a71 su* sponsor %all n rema9 legally committ$ to pay a us] fee because ( ! sponsor's notification ( int5t "u su* subp>agraph4 2 & 7#c7 9 subsection 7c71 by am5d+ p>agraph 7#b7 to read z foll[s3 7#b7 ,fee am\nt ,! am\nt ( ! priority review us] fee %all be det]m9$ ea* fiscal ye> by ! ,secret>y bas$ on ! diff]5ce betwe5-- 7,a7 ! av]age co/ incurr$ by ! ag5cy 9 ! review ( a human drug application subject to priority review 9 ! previ\s fiscal ye>2 & 7,b7 ! av]age co/ incurr$ by ! ,food & ,drug ,adm9i/ration 9 ! review ( a human drug application t is n subject to priority review 9 ! previ\s fiscal ye>4 4 #aje4 ,guidance on *anges to an approv$ application = biological products ,n lat] ?an #b ye>s aft] ! date ( enactm5t ( ?is ,act1 ! ,secret>y ( ,heal? & ,human ,s]vices %all issue f9al guidance t-- 7#a7 addresses *anges 9 a lic5s$ biological product or ! label+1 production process1 quality controls1 equipm5t1 facilities1 or responsible p]sonnel = su* a product e/abli%$ 9 ! application = ! product t 0 approv$ "u section #cea ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bfb72 7#b7 does n address su* *anges = specifi$ biote*nology or specifi$ syn!tic biological products li/$ 9 section #fja4b7;c7 ( title #ba ( ! ,code ( ,f$]al ,regulation2 & 7#c7 updates & sup]s$es ! guidance entitl$ ,*anges to an ,approv$ ,application3 ,biological ,products1 t 0 issu$ by ! ,food & ,drug ,adm9i/ration 9 ,july1 #aiig4 #ajf4 ,exp$it+ ! process = export c]tifications = vacc9es ,section #hja7;e77#d7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cha7;e77#d77 is am5d$-- 7#a7 9 ! matt] foll[+ clause 7ii7 9 subp>agraph 7,a71 by /rik+ )9 #bj days ( ! receipt ( a reque/ = su* c]tification & ins]t+ )9 #bj bus9ess days ( ! receipt ( a reque/ = su* c]tification1 except t 9 ! case ( a vacc9e ! ,secret>y %all issue su* c]tification )9 #aj bus9ess days ( ! receipt ( a reque/ = su* c]tification2 & 7#b7 9 subp>agraph 7,b71 by /rik+ )9 ! #bj days prescrib$ by subp>agraph 7,a7 & ins]t+ )9 ! p]iod prescrib$ by subp>agraph 7,a74 #ajg4 ,,nih vacc9e rese>* 7a7 ,9 g5]al ,subp>t #f ( "p ,c ( title ,,iv ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bhe;f et seq47 is am5d$ by add+ at ! end ! foll[+3 #ddg;,d4 ,advancem5t ( vacc9e developm5t ,9 c>ry+ out ! g5]al purpose describ$ 9 section #ddf1 ! ,director ( ! ,in/itute %all conduct or support translational sci5ce1 rese>*1 & rese>* tra9+ to advance ! developm5t ( vacc9es = ! prev5tion ( diseases1 includ+ ! advancem5t ( vacc9e developm5t programs into cl9ical trials4 4 7b7 ,review ( ,,nih vacc9e rese>* 7#a7 ,9 g5]al ,n lat] ?an "o ye> aft] ! date ( enactm5t ( ?is ,act1 ! ,director ( ! ,national ,in/itutes ( ,heal? %all-- 7,a7 conduct a review on vacc9e rese>* be+ conduct$ or support$ by ! ,in/itutes2 & 7,b7 publi% a report on ! results ( su* review4 7#b7 ,cont5ts ,at a m9imum1 ! report "u p>agraph 7#a77;,b7 %all-- 7,a7 describe intramural & extramural vacc9e rese>* & developm5t programs t are be+ conduct$ or support$ by ! ,national ,in/itutes ( ,heal?1 includ+ ^? t are translational or cl9ical phase /udies2 7,b7 provide a summ>y ( fund+ allocations made to conduct or support ! matt]s describ$ 9 section #ddg;,d ( ! ,public ,heal? ,s]vice ,act1 z add$ by subsection 7a71 & id5tify project$ fund+ ne$s ) reg>d to future rese>* or support ) reg>d to ^! matt]s2 & 7,c7 id5tify fund+ & collaborations ) ! private sector ?r\gh-- 7i7 ! ,small ,bus9ess ,innovation ,rese>* & ,small ,bus9ess ,te*nology ,transf] programs2 & 7ii7 coop]ative rese>* & developm5t agreem5ts4 ,,ii ,m$ic>e1 ,m$icaid1 & o!r provisions #bja4 ,requir+ prompt updates to ,m$ic>e program ^u issuance ( ,,acip recomm5dations ,9 ! case t ! advisory committee on immunization practices e/abli%$ by ! ,secret>y ( ,heal? & ,human ,s]vices pursuant to section #bbb ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bag;a7 issues a recomm5dation = a vacc9e or an update to a recomm5dation = a vacc9e t ! ,secret>y is us+ "u title ,,xviii ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acie et seq47 ) respect to cov]age ( vacc9es or immunizations "u su* title1 ! ,secret>y %all det]m9e :e!r or n to update policies "u su* title ) respect to su* cov]age on a date t is n lat] ?an #fj bus9ess days aft] ! date on :i* su* advisory committee issues su* recomm5dation or update4 #bjb4 ,,gao /udy & report on ,m$ic>e & ,m$icaid b5efici>y access = vacc9es 7a7 ,/udy ,! ,comptroll] ,g5]al ( ! ,unit$ ,/ates 79 ?is section ref]r$ to z ! ,comptroll] ,g5]al7 %all conduct a /udy on ! impact ( reimbursem5t rates "u ! ,m$ic>e program "u p>ts ,b1 ,c1 & ,d ( title ,,xviii ( ! ,social ,security ,act & "u ! ,m$icaid program "u title ,,xix ( su* ,act on access by t>get$ individuals to vacc9es recomm5d$ by ! ,advisory ,committee on ,immunization ,practices ( ! ,c5t]s = ,disease ,control & ,prev5tion4 ,su* /udy %all include an analysis & det]m9ation (-- 7#a7 ! reimbursem5t rates = vacc9es "u su* p>ts ( ! ,m$ic>e program & "u ! ,m$icaid program1 includ+ ^? rates paid by a ,,pdp sponsor "u "p ,d ( title ,,xviii ( su* ,act1 ,m$ic>e ,advantage organizations "u "p ,c ( su* title1 & ,m$icaid manag$ c>e organizations 7z def9$ 9 section #aijc7m77#a77;,a7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acif;b7m77#a77;,a772 7#b7 ! numb] ( t>get$ individuals dur+ ! #c-ye> p]iod prior to ! /udy :o 7 eligible = a vacc9ation recomm5d$ by ! ,advisory ,committee on ,immunization ,practices ( ! ,c5t]s = ,disease ,control & ,prev5tion2 7#c7 ! numb] ( su* t>get$ individuals :o actually receiv$ a vacc9ation describ$ 9 p>agraph 7#b71 ) a p>ticul> breakd[n ( adults1 ! eld]ly1 & populations locat$ 9 rural or und]s]v$ communities2 & 7#d7 ! ext5t to :i* ! reimbursem5t rates "u su* p>ts ( ! ,m$ic>e program & "u ! ,m$icaid program = vacc9ations describ$ 9 p>agraph 7#b7 affect _! use by physicians or access = su* t>get$ individuals4 7b7 ,t>get$ individuals ,= purposes ( subsection 7a71 ! t]m t>get$ individual means & individual :o is-- 7#a7 7,a7 entitl$ to b5efits "u "p ,a ( title ,,xviii ( ! ,social ,security ,act or enroll$ 9 "p ,b ( su* ,act2 or 7,b7 eligible = m$ical assi/ance "u title ,,xix ( su* ,act2 & 7#b7 )9 a vuln]able population4 7c7 ,report ,n lat] ?an #b ye>s aft] ! date ( enactm5t ( ?is ,act1 ! ,comptroll] ,g5]al %all submit to ! appropriate committees ( ! ,congress a report conta9+ ! results ( ! /udy conduct$ "u subsection 7a71 includ+-- 7#a7 a summ>y ( ! f9d+s ( ! /udy2 & 7#b7 recomm5dations bas$ on ! results ( ! /udy1 includ+ recomm5dations = su* legislative & adm9i/rative action z ! ,comptroll] ,g5]al det]m9es appropriate4 #bjc4 ,enc\rag+ heal? plans to e/abli% programs to increase adult immunization 7a7 ,private heal? plans ,section #bgah ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #cjj;gg-#ah7 is am5d$ by add+ at ! end ! foll[+ new subsection3 7f7 ,programs to increase adult immunization 7#a7 ,9 g5]al ,= purposes ( ?is section1 = plan ye>s beg9n+ on or aft] ! date ( enactm5t ( ! ,vacc9e ,access1 ,c]ta9ty1 & ,innovation ,act ( #bjae1 activities t improve heal? c>e quality describ$ 9 subsection 7a77#b7 %all include programs to increase adult immunization4 7#b7 ,adm9i/ration ,n lat] ?an ,decemb] #ca1 #bjaf1 ! ,secret>y %all e/abli% /&>diz$ me?odologies1 includ+ def9itions1 = :i* activities1 & 9 :at reg>d su* activities1 con/itute programs to increase adult immunization 9 accordance ) ?is subsection4 ,! ,secret>y %all consult ) relevant /akehold]s 9 e/abli%+ su* me?odologies4 4 7b7 ,m$ic>e ,advantage & "p ,d plans ,section #aheg7;e7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#bg7;e77 is am5d$ by add+ at ! end ! foll[+ new p>agraph3 7#e7 ,inclusion ( exp5ditures on programs to increase adult immunization 9 m9imum m$ical loss ratio calculation ,= purposes ( calculat+ ! m9imum m$ical loss ratio "u p>agraph 7#d71 = plan ye>s beg9n+ at lea/ #ab mon?s aft] ! date ( enactm5t ( ?is ,act1 ! num]ator %all include any exp5ditures on programs to increase adult immunization4 4