#aad? ,,congress #a/ ,session ,h4 ,r4 #f ,,an ,,act ,to accel]ate ! discov]y1 developm5t1 & deliv]y ( #ba/ c5tury cures1 & = o!r purposes4 #a4 ,%ort title2 table ( cont5ts 7a7 ,%ort title ,?is ,act may be cit$ z ! #ba/ ,c5tury ,cures ,act4 7b7 ,table ( cont5ts ,! table ( cont5ts = ?is ,act is z foll[s3 ,sec4 #a4 ,%ort title2 table ( cont5ts4 ,sec4 #b4 ,,nih & ,cures ,innovation ,fund4 ,title ,i--,discov]y ,subtitle ,a--,national ,in/itutes ( ,heal? ,fund+ ,sec4 #ajja4 ,national ,in/itutes ( ,heal? reau?orization4 ,sec4 #ajjb4 ,prize competitions4 ,subtitle ,b--,national ,in/itutes ( ,heal? ,plann+ & ,adm9i/ration ,sec4 #ajba4 ,,nih rese>* /rategic plan4 ,sec4 #ajbb4 ,increas+ acc\ntability at ! ,national ,in/itutes ( ,heal?4 ,sec4 #ajbc4 ,r$uc+ adm9i/rative burd5s ( rese>*]s4 ,sec4 #ajbd4 ,exemption = ! ,national ,in/itutes ( ,heal? f ! ,pap]work ,r$uction ,act requirem5ts4 ,sec4 #ajbe4 ,,nih travel4 ,sec4 #ajbf4 ,o!r transactions au?ority4 ,sec4 #ajbg4 ,,ncats phase ,,iib re/riction4 ,sec4 #ajbh4 ,high-risk1 high-rew>d rese>*4 ,sec4 #ajbi4 ,s5se ( ,congress on increas$ inclusion ( und]repres5t$ communities 9 cl9ical trials4 ,subtitle ,c--,support+ ,"y ,em]g+ ,sci5ti/s ,sec4 #ajda4 ,improvem5t ( loan repaym5t programs ( ! ,national ,in/itutes ( ,heal?4 ,sec4 #ajdb4 ,report4 ,subtitle ,d--,cap/one ,grant ,program ,sec4 #ajfa4 ,cap/one aw>d4 ,subtitle ,e--,promot+ ,p$iatric ,rese>* ?r\gh ! ,national ,in/itutes ( ,heal? ,sec4 #ajha4 ,national p$iatric rese>* network4 ,sec4 #ajhb4 ,global p$iatric cl9ical /udy network s5se ( ,congress4 ,sec4 #ajhc4 ,appropriate age gr\p+s 9 cl9ical rese>*4 ,subtitle ,f--,advancem5t ( ! ,national ,in/itutes ( ,heal? ,rese>* & ,data ,access ,sec4 #aaja4 ,/&>dization ( data 9 ,cl9ical ,trial ,regi/ry ,data ,bank on eligibility = cl9ical trials4 ,subtitle ,g--,facilitat+ ,collaborative ,rese>* ,sec4 #aaba4 ,cl9ical trial data sy/em4 ,sec4 #aabb4 ,national neurological diseases surveillance sy/em4 ,sec4 #aabc4 ,data on natural hi/ory ( diseases4 ,sec4 #aabd4 ,access+1 %>+1 & us+ heal? data = rese>* purposes4 ,subtitle ,h--,c\ncil = #ba/ ,c5tury ,cures ,sec4 #aada4 ,c\ncil = #ba/ ,c5tury ,cures4 ,title ,,ii--,developm5t ,subtitle ,a--,pati5t-,focus$ ,drug ,developm5t ,sec4 #bjja4 ,developm5t & use ( pati5t exp]i5ce data to enhance /ructur$ risk-b5efit assessm5t framework4 ,subtitle ,b--,qualification & ,use ( ,drug ,developm5t ,tools ,sec4 #bjba4 ,qualification ( drug developm5t tools4 ,sec4 #bjbb4 ,accel]at$ approval developm5t plan4 ,subtitle ,c--,,fda advancem5t ( ,precision ,m$ic9e ,sec4 #bjda4 ,precision m$ic9e guidance & o!r programs ( ,food & ,drug ,adm9i/ration4 ,subtitle ,d--,mod]n ,trial ,design & ,evid5ce ,developm5t ,sec4 #bjfa4 ,broad] application ( ,bayesian /ati/ics & adaptive trial designs4 ,sec4 #bjfb4 ,utiliz+ evid5ce f cl9ical exp]i5ce4 ,sec4 #bjfc4 ,/reaml9$ data review program4 ,subtitle ,e--,exp$it+ ,pati5t ,access ,sec4 #bjha4 ,s5se ( ,congress4 ,sec4 #bjhb4 ,exp&$ access policy4 ,sec4 #bjhc4 ,f9aliz+ draft guidance on exp&$ access4 ,subtitle ,f--,facilitat+ responsible manufactur] communications ,sec4 #baja4 ,facilitat+ dissem9ation ( heal? c>e economic in=mation4 ,sec4 #bajb4 ,facilitat+ responsible communication ( sci5tific & m$ical developm5ts4 ,subtitle ,g--,antibiotic ,drug ,developm5t ,sec4 #baba4 ,approval ( c]ta9 drugs = use 9 a limit$ population ( pati5ts4 ,sec4 #babb4 ,susceptibility te/ int]pretive crit]ia = microorganisms4 ,sec4 #babc4 ,enc\rag+ ! developm5t & use ( ,,dis>m drugs4 ,subtitle ,h--,vacc9e ,access1 ,c]ta9ty1 & ,innovation ,sec4 #bada4 ,timely review ( vacc9es by ! ,advisory ,committee on ,immunization ,practices4 ,sec4 #badb4 ,review ( processes & consi/5cy ( ,,acip recomm5dations4 ,sec4 #badc4 ,meet+s betwe5 ,,cdc & vacc9e develop]s4 ,subtitle ,i--,orphan product ext5sions n[2 inc5tives = c]ta9 products = limit$ populations ,sec4 #baea4 ,ext5sion ( exclusivity p]iods = a drug approv$ = a new indication = a r>e disease or condition4 ,sec4 #baeb4 ,reau?orization ( r>e p$iatric disease priority review v\*] inc5tive program4 ,subtitle ,j--,dome/ic ,manufactur+ & ,export ,effici5cies ,sec4 #bafa4 ,grants = /udy+ ! process ( cont9u\s drug manufactur+4 ,sec4 #bafb4 ,re-exportation among memb]s ( ! ,european ,economic ,area4 ,subtitle ,k--,enhanc+ comb9ation products review ,sec4 #baha4 ,enhanc+ comb9ation products review4 ,subtitle ,l--,priority ,review = ,break?r\gh ,devices ,sec4 #bbja4 ,priority review = break?r\gh devices4 ,subtitle ,m--,m$ical ,device ,regulatory ,process ,improvem5ts ,sec4 #bbba4 ,?ird-p>ty quality sy/em assessm5t4 ,sec4 #bbbb4 ,valid sci5tific evid5ce4 ,sec4 #bbbc4 ,tra9+ & ov]sight 9 lea/ burd5some appropriate means concept4 ,sec4 #bbbd4 ,recognition ( /&>ds4 ,sec4 #bbbe4 ,eas+ regulatory burd5 ) respect to c]ta9 class ,i & class ,,ii devices4 ,sec4 #bbbf4 ,advisory committee process4 ,sec4 #bbbg4 ,humanit>ian device exemption application4 ,sec4 #bbbh4 ,,clia waiv] /udy design guidance = 9 vitro diagno/ics4 ,subtitle ,n--,s5sible ,ov]sight = ,te*nology ,:i* ,advances ,regulatory ,effici5cy ,sec4 #bbda4 ,heal? s(tw>e4 ,sec4 #bbdb4 ,applicability & inapplicability ( regulation4 ,sec4 #bbdc4 ,exclusion f def9ition ( device4 ,subtitle ,o--,/reaml9+ ,cl9ical ,trials ,sec4 #bbfa4 ,protection ( human subjects 9 rese>*2 applicability ( rules4 ,sec4 #bbfb4 ,use ( non-local in/itutional review bo>ds = review ( inve/igational device exemptions & human device exemptions4 ,sec4 #bbfc4 ,alt]ation or waiv] ( in=m$ cons5t = cl9ical inve/igations4 ,subtitle ,p--,improv+ ,sci5tific ,exp]tise & ,outrea* at ,,fda ,sec4 #bbha4 ,silvio ,o4 ,conte ,s5ior ,biom$ical ,rese>* ,s]vice4 ,sec4 #bbhb4 ,enabl+ ,,fda sci5tific engagem5t4 ,sec4 #bbhc4 ,reagan-,udall ,f\ndation = ! ,food & ,drug ,adm9i/ration4 ,sec4 #bbhd4 ,collection ( c]ta9 volunt>y in=mation exempt$ f ,pap]work ,r$uction ,act4 ,sec4 #bbhe4 ,hir+ au?ority = sci5tific1 te*nical1 & pr(essional p]sonnel4 ,subtitle ,q--,exempt+ f seque/ration c]ta9 us] fees ,sec4 #bcja4 ,exempt+ f seque/ration c]ta9 us] fees ( ,food & ,drug ,adm9i/ration4 ,subtitle ,r--,o!r provisions ,sec4 #bcba4 ,s5se ( ,congress4 ,title ,,iii--,deliv]y ,subtitle ,a--,int]op]ability ,sec4 #cjja4 ,ensur+ int]op]ability ( heal? in=mation te*nology4 ,subtitle ,b--,teleheal? ,sec4 #cjba4 ,teleheal? s]vices "u ! ,m$ic>e ,program4 ,subtitle ,c--,enc\rag+ ,cont9u+ ,m$ical ,education = ,physicians ,sec4 #cjda4 ,exempt+ f manufactur] transp>5cy report+ c]ta9 transf]s us$ = educational purposes4 ,subtitle ,d--,disposable ,m$ical ,te*nologies ,sec4 #cjfa4 ,treatm5t ( c]ta9 items & devices4 ,subtitle ,e--,local cov]age decision re=ms ,sec4 #cjha4 ,improvem5ts 9 ! ,m$ic>e local cov]age det]m9ation 7,,lcd7 process4 ,subtitle ,f--,m$ic>e ,ph>maceutical & ,te*nology ,ombudsman ,sec4 #caja4 ,m$ic>e ph>maceutical & te*nology ombudsman4 ,subtitle ,g--,m$ic>e site-(-,s]vice price transp>5cy ,sec4 #caba4 ,m$ic>e site-(-,s]vice price transp>5cy4 ,subtitle ,h--,m$ic>e ,"p ,d ,pati5t ,safety & ,drug ,abuse ,prev5tion ,sec4 #cada4 ,programs to prev5t prescription drug abuse "u ,m$ic>e p>ts ,c & ,d4 ,title ,,iv--,m$icaid1 ,m$ic>e1 & ,o!r ,re=ms ,subtitle ,a--,m$icaid & ,m$ic>e ,re=ms ,sec4 #djja4 ,limit+ ,f$]al ,m$icaid reimbursem5t to ,/ates = durable m$ical equipm5t 7,,dme7 to ,m$ic>e paym5t rates4 ,sec4 #djjb4 ,exclud+ au?oriz$ g5]ics f calculation ( av]age manufactur] price4 ,sec4 #djjc4 ,m$ic>e paym5t inc5tive = ! transition f traditional x-ray imag+ to digital radiography & o!r ,m$ic>e imag+ paym5t provision4 ,sec4 #djjd4 ,treatm5t ( infusion drugs furni%$ ?r\gh durable m$ical equipm5t4 ,sec4 #djje4 ,ext5sion & expansion ( prior au?orization = p[] mobility devices 7,p,m,ds7 & accessories & prior au?orization audit limitations4 ,sec4 #djjf4 ,civil monet>y p5alties = violations relat$ to grants1 contracts1 & o!r agreem5ts4 ,subtitle ,b--,o!r ,re=ms ,sec4 #djda4 ,,spr drawd[n4 ,subtitle ,c--,miscellane\s ,sec4 #djfa4 ,lyme disease & o!r tick-borne diseases4 ,sec4 #djfb4 ,outrea* to hi/orically black colleges & univ]sities4 #b4 ,,nih & ,cures ,innovation ,fund 7a7 ,e/abli%m5t ,!re is h]eby e/abli%$ 9 ! ,treasury ( ! ,unit$ ,/ates a fund to be kn[n z ! ,,nih & ,cures ,innovation ,fund4 7b7 ,am\nts made available to ,fund 7#a7 ,9 g5]al ,!re is au?oriz$ to be appropriat$1 & appropriat$1 to ! ,,nih & ,cures ,innovation ,fund1 out ( any funds 9 ! ,treasury n o!rwise appropriat$1 #a1hfj1jjj1jjj = ea* ( fiscal ye>s #bjaf ?r\gh #bjbj4 ,! am\nts appropriat$ to ! ,,nih & ,cures ,innovation ,fund by ! prec$+ s5t5ce %all be 9 addition to any am\nts o!rwise made available to ! ,dep>tm5t ( ,heal? & ,human ,s]vices4 7#b7 ,allocation ( am\nts ,( ! am\nts made available f ! ,,nih & ,cures ,innovation ,fund = a fiscal ye>-- 7,a7 #a1gej1jjj1jjj %all be = biom$ical rese>* ( ! ,national ,in/itutes ( ,heal? "u subsection 7c77#a71 ( :i*-- 7i7 n less ?an #ejj1jjj1jjj %all be = ! ,accel]at+ ,advancem5t ,program "u subsection 7d77#b72 7ii7 n less ?an #ce p]c5t ( su* am\nts rema9+ aft] subtract+ ! allocation = ! ,accel]at+ ,advancem5t ,program %all be = e>ly /age inve/igators z def9$ 9 subsection 7g72 7iii7 n less ?an #bj p]c5t ( su* am\nts rema9+ aft] subtract+ ! allocation = ! ,accel]at+ ,advancem5t ,program %all be = high-risk1 high-rew>d rese>* "u section #dji,l ( ! ,public ,heal? ,s]vice ,act1 z add$ by section #ajbh2 & 7iv7 n m ?an #aj p]c5t ( su* am\nts 7)\t subtract+ ! allocation = ! ,accel]at+ ,advancem5t ,program7 %all be = intramural rese>*2 & 7,b7 #aaj1jjj1jjj %all be = c>ry+ out ! provisions li/$ 9 subsection 7c77#b74 7#c7 ,inapplicability ( c]ta9 provisions ,am\nts 9 ! ,,nih & ,cures ,innovation ,fund 7includ+ am\nts made available to ! ,national ,in/itutes ( ,heal?7 %all n be subject to-- 7,a7 any transf] au?ority ( ! ,secret>y ( ,heal? & ,human ,s]vices or ! ,director ( ! ,national ,in/itutes ( ,heal? "u sections #bda1 #djb;,a7c71 or #djb;,a7d7 ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bch;j1 #bhb;a7c7 & 7d77 or any o!r provision ( law 7o!r ?an ?is section72 or 7,b7 ! ,nonrecurr+ exp5ses fund "u section #bbc ( division ,g ( ! ,consolidat$ ,appropriations ,act1 #bjjh 7#db ,u4,s4,c4 #cead;a74 7c7 ,au?oriz$ uses 7#a7 ,,nih biom$ical rese>* ,am\nts 9 ! ,,nih & ,cures ,innovation ,fund t are allocat$ pursuant to subsection 7b77#b77;,a7 may only be us$ = ! purpose ( conduct+ or support+ biom$ical rese>* 7includ+ basic1 translational1 & cl9ical rese>*7 ?r\gh ! foll[+3 7,a7 ,rese>* 9 :i*-- 7i7 a pr9cipal inve/igator has a specific project or specific objectives2 & 7ii7 fund+ is ti$ to pursuit ( su* project or objectives4 7,b7 ,rese>* 9 :i*-- 7i7 a pr9cipal inve/igator has %[n promise 9 biom$ical rese>*2 & 7ii7 fund+ is n ti$ to a specific project or specific objectives4 7,c7 ,rese>* to be c>ri$ out by an e>ly /age inve/igator 7z def9$ 9 subsection 7g774 7,d7 ,rese>* to be c>ri$ out by a small bus9ess conc]n 7z def9$ 9 section #c ( ! ,small ,bus9ess ,act74 7,e7 ,! ,accel]at+ ,advancem5t ,program "u subsection 7d77#b74 7,f7 ,developm5t & implem5tation ( ! /rategic plan "u subsection 7d77#c74 7#b7 ,cures developm5t ,am\nts 9 ! ,,nih & ,cures ,innovation ,fund t are allocat$ pursuant to subsection 7b77#b77;,b7 may only be us$ = ! purpose ( c>ry+ out ! foll[+ provisions3 7,a7 ,section #bbi;,a ( ! ,public ,heal? ,s]vice ,act1 z add$ by section #aabc 7relat+ to data on natural hi/ory ( diseases74 7,b7 ,section #bjja & ! am5dm5ts made by su* section 7relat+ to developm5t & use ( pati5t exp]i5ce data to enhance /ructur$ risk-b5efit assessm5t framework74 7,c7 ,section #bjba & ! am5dm5ts made by su* section 7relat+ to qualification ( drug developm5t tools74 7,d7 ,section #bjfb & ! am5dm5ts made by su* section 7relat+ to utiliz+ evid5ce f cl9ical exp]i5ce74 7,e7 ,section #bafa 7relat+ to grants = /udy+ ! process ( cont9u\s drug manufactur+74 7,f7 ,section #bbja & ! am5dm5ts made by su* section 7relat+ to priority review = break?r\gh devices74 7,g7 ,section #bbba & ! am5dm5ts made by su* section 7relat+ to ?ird-p>ty quality sy/em assessm5ts74 7,h7 ,sections #bbda1 #bbdb1 & #bbdc & ! am5dm5ts made by su* sections 7relat+ to heal? s(tw>e74 7,i7 ,section #eac7;j7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act1 z add$ by section #bbbc 7relat+ to tra9+ & ov]sight 9 lea/ burd5some appropriate means concept74 7d7 ,,nih ,innovation ,fund 7#a7 ,coord9ation ,9 conduct+ or support+ biom$ical rese>* pursuant to funds allocat$ pursuant to subsection 7b77#b77;,a71 ! ,secret>y ( ,heal? & ,human ,s]vices1 act+ ?r\gh ! ,director ( ! ,national ,in/itutes ( ,heal?1 %all-- 7,a7 ensure coord9ation among ! national rese>* in/itutes1 ! national c5t]s1 & o!r dep>tm5ts1 ag5cies1 & (fices ( ! ,f$]al ,gov]nm5t2 & 7,b7 m9imize unnecess>y duplication4 7#b7 ,accel]at+ ,advancem5t ,program ,! ,director ( ! ,national ,in/itutes ( ,heal? %all e/abli% a program1 to be kn[n z ! ,accel]at+ ,advancem5t ,program1 "u :i*-- 7,a7 ! ,director p>tn]s ) national rese>* in/itutes & national c5t]s to accompli% important biom$ical rese>* objectives2 & 7,b7 = e #a made available by ! ,director to a national rese>* in/itute or national c5t] = a rese>* project1 ! in/itute or c5t] makes #a available = su* project f funds t are n d]iv$ f ! ,,nih & ,cures ,innovation ,fund4 7#c7 ,/rategic plan 7,a7 ,9 g5]al ,! ,director ( ! ,national ,in/itutes ( ,heal? %all ensure t sci5tifically bas$ /rategic plann+ is implem5t$ 9 support ( rese>* priorities1 includ+ ?r\gh developm5t1 use1 & updat+ ( a rese>* /rategic plan t-- 7i7 is design$ to increase ! effici5t & effective focus ( biom$ical rese>* 9 a mann] t lev]ages ! be/ sci5tific opportunities ?r\gh a delib]ative plann+ process2 7ii7 id5tifies areas1 to be kn[n z /rategic focus areas1 9 :i* ! res\rces ( ! ,,nih & ,cures ,innovation ,fund c contribute to ! goals ( exp&+ k to address1 & f9d m effective treatm5ts =1 unmet m$ical ne$s 9 ! ,unit$ ,/ates1 includ+ ! areas (-- 7,i7 biom>k]s2 7,,ii7 precision m$ic9e2 7,,iii7 infecti\s diseases1 includ+ pa?og5s li/$ z a qualify+ pa?og5 "u section #eje;,e7f7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act or li/$ or designat$ z a tropical disease "u section #ebd ( su* ,act2 & 7,,iv7 antibiotics2 7iii7 includes objectives = ea* su* /rategic focus area2 & 7iv7 ensures t basic rese>* rema9s a priority4 7,b7 ,updates & reviews ,! ,director ( ! ,national ,in/itutes ( ,heal? %all review &1 z appropriate1 update ! rese>* /rategic plan "u subp>agraph 7,a7 n less ?an e #ah mon?s4 7e7 ,transf] au?ority ,! ,committee on ,appropriations ( ! ,s5ate & ! ,committee on ,appropriations ( ! ,h\se ( ,repres5tatives may provide = ! transf] ( funds 9 ! ,,nih & ,cures ,innovation ,fund = ! purposes specifi$ 9 subsection 7c74 7f7 ,supplem5t1 n supplant2 limitations ,funds appropriat$ by subsection 7b7-- 7#a7 %all be us$ to supplem5t1 n supplant1 am\nts o!rwise made available to ! ,dep>tm5t ( ,heal? & ,human ,s]vices2 7#b7 are subject to ! requirem5ts & limitations ( ! mo/ rec5tly enact$ regul> or full-ye> cont9u+ appropriation ,act or resolution 7z ( ! date ( obligation7 = programs ( ! ,national ,in/itutes ( ,heal? or ! ,food & ,drug ,adm9i/ration1 z applicable2 & 7#c7 not)/&+ any transf] au?ority 9 any appropriation ,act1 %all n be us$ = any purpose o!r ?an ! purposes specifi$ 9 subsection 7c74 7g7 ,def9ition ,9 ?is subsection3 7#a7 ,! t]m e>ly /age inve/igator means an inve/igator :o-- 7,a7 w be ! pr9cipal inve/igator or ! program director ( ! propos$ rese>*2 7,b7 has nev] be5 aw>d$1 or has be5 aw>d$ only once1 a sub/antial1 compet+ grant by ! ,national ,in/itutes ( ,heal? = indep5d5t rese>*2 & 7,c7 is )9 #aj ye>s ( hav+ complet$-- 7i7 ! inve/igator's t]m9al degree2 or 7ii7 a m$ical resid5cy 7or ! equival5t74 7#b7 ,! t]ms national c5t] & national rese>* in/itute h ! mean+s giv5 to ^? t]ms 9 section #dja7;g7 ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bha7;g774 ,i ,discov]y ,a ,national ,in/itutes ( ,heal? ,fund+ #ajja4 ,national ,in/itutes ( ,heal? reau?orization ,section #djb;,a7a77#a7 ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bhb;a7a77#a77 is am5d$-- 7#a7 9 subp>agraph 7,b71 by /rik+ at ! end &2 7#b7 9 subp>agraph 7,c71 by /rik+ at ! end ! p]iod & ins]t+ a semicolon2 & 7#c7 by add+ at ! end ! foll[+ new subp>agraphs3 7,d7 #ca1haa1jjj1jjj = fiscal ye> #bjaf2 7,e7 #cc1cca1jjj1jjj = fiscal ye> #bjag2 & 7,f7 #cd1hea1jjj1jjj = fiscal ye> #bjah4 4 #ajjb4 ,prize competitions ,"p ,b ( title ,,iv ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bhd et seq47 is am5d$ by add+ at ! end ! foll[+3 #dji,k4 ,prize competitions = improv+ heal? outcomes & r$uc+ ,f$]al exp5ditures 7a7 ,e/abli%m5t2 goals ,! ,director ( ,,nih %all e/abli% & implem5t an ,innovation ,prizes ,program = "o or bo? ( ! foll[+ goals3 7#a7 ,id5tify+ & fund+ areas ( biom$ical sci5ce t c\ld realize significant advancem5ts ?r\gh ! creation ( a prize competition4 7#b7 ,improv+ heal? outcomes1 p>ticul>ly ) respect to human diseases & conditions = :i* public & private inve/m5t 9 rese>* is disproportionately small relative to ,f$]al ,gov]nm5t exp5ditures on prev5tion & treatm5t activities1 !reby r$uc+ ,f$]al exp5ditures on heal? programs4 7b7 ,design ( prize competitions ,n lat] ?an #f mon?s aft] ! date ( enactm5t ( ?is section1 ! ,director ( ,,nih %all-- 7#a7 design prize competitions-- 7,a7 to coop]ate ) competitors to realize innovations to id5tify & address areas ( biom$ical sci5ce t c\ld realize significant advancem5ts ?r\gh ! creation ( a prize competition2 & 7,b7 to aw>d "o or m prizes-- 7i7 if appropriate1 at ! beg9n+ ( or dur+ ! competitions1 to ! competitors ^: innovations are mo/ promis+ or demon/rate progress2 & 7ii7 at ! end ( ! competitions1 to ! competitors ^: innovations prove to be ! be/ solutions2 7#b7 ensure t ! design ( su* competitions-- 7,a7 is reali/ic1 giv5 ! am\nt ( funds to be aw>d$ z prizes2 7,b7 does n reflect any bias conc]n+ ! type ( innovations :i* w prove to be ! be/ solutions2 & 7,c7 all[s any p]son to p>ticipate z a competitor )\t reg>d to ! p]son's place ( incorporation1 prim>y place ( bus9ess1 citiz5%ip1 & resid5cy1 z applicable2 & 7#c7 submit to ! ,congress a report on ! design ( su* competitions4 7c7 ,innovation ,prizes ,advisory ,bo>d 7#a7 ,e/abli%m5t ,! ,director ( ,,nih %all e/abli% & ma9ta9 a bo>d1 to be kn[n z ! ,i-,prize ,bo>d1 to advise & assi/ ! ,director ( ,,nih 9 c>ry+ out ?is section4 7#b7 ,composition2 t]ms 7,a7 ,composition ,! ,i-,prize ,bo>d %all be compos$ ( n9e vot+ memb]s z foll[s3 7i7 ,! ,director ( ,,nih 7or ! ,director's designee74 7ii7 ,f\r memb]s appo9t$ by ! ,director ( ,,nih4 7iii7 ,"o memb] appo9t$ by ! ,speak] ( ! ,h\se ( ,repres5tatives4 7iv7 ,"o memb] appo9t$ by ! majority lead] ( ! ,s5ate4 7v7 ,"o memb] appo9t$ by ! m9ority lead] ( ! ,h\se ( ,repres5tatives4 7vi7 ,"o memb] appo9t$ by ! m9ority lead] 9 ! ,s5ate4 7,b7 ,inclusion ( c]ta9 exp]ts ,! memb]s ( ! ,i-,prize ,bo>d appo9t$ "u clauses 7ii7 ?r\gh 7vi7 ( subp>agraph 7,a7 %all1 collectively1 include m$ical1 economic1 budget>y1 innovation1 or v5ture capital exp]ts f =-pr(it & n-=-pr(it private sector entities ) exp]i5ce 9 aw>d+ prizes simil> to ! prizes "u ?is section4 7,c7 ,t]ms ,! appo9t$ memb]s ( ! ,i-,prize ,bo>d %all ea* be appo9t$ = a t]m ( #e ye>s4 7,d7 ,appo9tm5t ( initial memb]s ,! initial appo9t$ memb]s ( ! ,i-,prize ,bo>d %all be appo9t$ n lat] ?an #abj days aft] ! date ( enactm5t ( ?is section4 7#c7 ,responsibilities ,! ,i-,prize ,bo>d %all be responsible = advis+ ! ,director ( ,,nih by-- 7,a7 id5tify+ areas ( biom$ical sci5ce t c\ld realize significant advancem5ts ?r\gh ! creation ( a prize competition2 7,b7 mak+ recomm5dations on e/abli%+ ! crit]ia = prize competitions "u ?is section2 7,c7 mak+ recomm5dations on :i* bus9ess organizations or o!r entities h successfully met ! crit]ia e/abli%$ = ! prize competition2 & 7,d7 ga9+ insight f rese>*]s1 heal? economi/s1 academia1 & indu/ry on h[ to conduct prize competitions4 7d7 ,re/rictions 7#a7 ,no f9ancial conflicts ( int]e/ ,any memb] ( ! ,i-,prize ,bo>d1 & any (fic] or employee ( ! ,national ,in/itutes ( ,heal? responsible = c>ry+ out ?is section1 may n p]sonally or sub/antially p>ticipate 9 ! consid]ation or det]m9ation by ! ,i-,prize ,bo>d ( any matt] t w\ld directly or pr$ictably effect any f9ancial int]e/ (-- 7,a7 ! individual or a relative 7z su* t]m is def9$ 9 section #aji7af7 ( ! ,e?ics 9 ,gov]nm5t ,act ( #aigh7 ( ! individual2 or 7,b7 ( any bus9ess organization or o!r entity-- 7i7 ( :i* ! individual is an (fic] or employee2 7ii7 ) respect to :i* ! individual is negotiat+ = employm5t2 or 7iii7 9 :i* ! individual has any o!r f9ancial int]e/4 7#b7 ,no aw>ds to competitors likely to reap f9ancial b5efit f innovation ,! ,director ( ,,nih may n1 ) respect to an innovation1 aw>d a prize "u ?is section to any individual or entity t has a ve/$ f9ancial int]e/ 9 any product or proc$ure t is likely to be develop$ or m>ket$ because ( su* innovation4 7e7 ,process ( aw>d ,! full monet>y am\nt ( any prize aw>d$ "u ?is section %all be made available to ! prize w9n] n lat] ?an #ij days aft] ! date ( su* aw>d4 7f7 ,simulation ,! ,director ( ,,nih may-- 7#a7 aw>d "o or m contracts-- 7,a7 to p]=m a simulation ( ! prize competitions to be conduct$ "u ?is section1 bas$ on ! designs develop$ "u subsection 7b72 & 7,b7 to use ! simulation to assess ! effectiv5ess ( ! design2 & 7#b7 n lat] ?an #d mon?s aft] aw>d+ su* "o or m contracts1 submit to ! ,congress a report on ! results ( ! simulation & assessm5t4 7g7 ,implem5tation ( prize competitions 7#a7 ,9 g5]al ,! ,director ( ,,nih may ent] into an agreem5t ) "o or m entities describ$ 9 section #eja7;c71 & exempt f tax "u section #eja7;a71 ( ! ,int]nal ,rev5ue ,code ( #aihf to implem5t prize competitions bas$ on ! designs develop$ "u subsection 7b74 7#b7 ,m9imum p]c5tage = prizes ,if ! ,director ( ,,nih ent]s into an agreem5t "u p>agraph 7#a7 to provide funds or o!r assi/ance 7includ+ 9-k9d contributions & te/+ or o!r te*nical support7 to an entity to implem5t a prize competition "u ?is section-- 7,a7 n m ?an #ae p]c5t ( su* assi/ance %all be = adm9i/ration ( ! prize competition2 & 7,b7 n less ?an #he p]c5t ( su* assi/ance %all be = activities 9 direct support ( competitors su* z demon/ration1 te/+1 education1 & prize aw>ds4 7h7 ,track+2 report+ ,! ,director ( ,,nih %all-- 7#a7 collect in=mation on-- 7,a7 ! m$ical efficacy ( innovations fund$ ?r\gh ! prize competitions "u ?is section2 & 7,b7 ! actual & pot5tial effect ( ! innovations on ,f$]al exp5ditures2 & 7#b7 n lat] ?an #a ye> aft] ! conclusion ( ! prize competitions "u ?is section1 & n lat] ?an ! end ( ea* ( ! #d succe$+ ye>s1 submit to ! ,congress a report on ! in=mation collect$ "u p>agraph 7#a74 7i7 ,intellectual prop]ty 7#a7 ,prohibition on ! gov]nm5t acquir+ intellectual prop]ty rights ,! ,f$]al ,gov]nm5t may n ga9 an int]e/ 9 intellectual prop]ty develop$ by a p>ticipant 9 a prize competition "u ?is section )\t ! writt5 cons5t ( ! p>ticipant4 7#b7 ,lic5ses ,! ,f$]al ,gov]nm5t may negotiate a lic5se = ! use ( intellectual prop]ty develop$ by a p>ticipant 9 a prize competition "u ?is section4 4 ,b ,national ,in/itutes ( ,heal? ,plann+ & ,adm9i/ration #ajba4 ,,nih rese>* /rategic plan ,section #djb ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bhb7 is am5d$-- 7#a7 9 subsection 7b71 by am5d+ p>agraph 7#e7 to read z foll[s3 7#e7 %all ensure t sci5tifically bas$ /rategic plann+ is implem5t$ 9 support ( rese>* priorities z det]m9$ by ! ag5cies ( ! ,national ,in/itutes ( ,heal?1 includ+ ?r\gh developm5t1 use1 & updat+ ( ! rese>* /rategic plan "u subsection 7m72 2 & 7#b7 by add+ at ! end ! foll[+3 7m7 ,rese>* /rategic plan 7#a7 ,five-ye> plans = biom$ical rese>* /rategy 7,a7 ,9 g5]al ,= ea* successive #e-ye> p]iod beg9n+ ) ! p]iod ( fiscal ye>s #bjaf ?r\gh #bjbj1 ! ,director ( ,,nih1 9 consultation ) ! entities describ$ 9 subp>agraph 7,b71 %all develop & ma9ta9 a biom$ical rese>* /rategic plan t-- 7i7 is design$ to increase ! effici5t & effective focus ( biom$ical rese>* 9 a mann] t lev]ages ! be/ sci5tific opportunities ?r\gh a delib]ative plann+ process2 7ii7 id5tifies areas1 to be kn[n z /rategic focus areas1 9 :i* ! res\rces ( ! ,national ,in/itutes ( ,heal? c be/ contribute to ! goal ( exp&+ k on human heal? 9 ! ,unit$ ,/ates ?r\gh biom$ical rese>*2 & 7iii7 includes objectives = ea* su* /rategic focus area4 7,b7 ,entities describ$ ,! entities describ$ 9 ?is subp>agraph are ! directors ( ! national rese>* in/itutes & national c5t]s1 rese>*]s1 pati5t advocacy gr\ps1 & indu/ry lead]s4 7#b7 ,use ( plan ,! ,director ( ,,nih & ! directors ( ! national rese>* in/itutes & national c5t]s %all use ! /rategic plan-- 7,a7 to id5tify rese>* opportunities2 & 7,b7 to develop individual /rategic plans = ! rese>* activities ( ea* ( ! national rese>* in/itutes & national c5t]s t-- 7i7 h a common template2 & 7ii7 id5tify /rategic focus areas 9 :i* ! res\rces ( ! national rese>* in/itutes & national c5t]s c be/ contribute to ! goal ( exp&+ k on human heal? 9 ! ,unit$ ,/ates ?r\gh biom$ical rese>*4 7#c7 ,cont5ts ( plans 7,a7 ,/rategic focus areas ,! /rategic focus areas id5tifi$ pursuant to p>agraph 7#a77;,a77ii7 %all-- 7i7 be id5tifi$ 9 a mann] t-- 7,i7 consid]s ! return on inve/m5t to ! ,unit$ ,/ates public ?r\gh ! inve/m5ts ( ! ,national ,in/itutes ( ,heal? 9 biom$ical rese>*2 & 7,,ii7 contributes to exp&+ k to improve ! ,unit$ ,/ates public's heal? ?r\gh biom$ical rese>*2 & 7ii7 include ov]>*+ & trans-,national ,in/itutes ( ,heal? /rategic focus areas1 to be kn[n z ,mission ,priority ,focus ,areas1 :i* be/ s]ve ! goals ( prev5t+ or elim9at+ ! burd5 ( a disease or condition & sci5tifically m]it enhanc$ & focus$ rese>* ov] ! next #e ye>s4 7,b7 ,r>e & p$iatric diseases & conditions ,9 develop+ & ma9ta9+ a /rategic plan "u ?is subsection1 ! ,director ( ,,nih %all ensure t r>e & p$iatric diseases & conditions rema9 a priority4 7,c7 ,work=ce ,9 develop+ & ma9ta9+ a /rategic plan "u ?is subsection1 ! ,director ( ,,nih %all ensure t ma9ta9+ ! biom$ical work=ce ( ! future1 includ+ ! p>ticipation by sci5ti/s f gr\ps traditionally und]repres5t$ 9 ! sci5tific work=ce1 rema9s a priority4 7#d7 ,initial plan ,n lat] ?an #bgj days aft] ! date ( enactm5t ( ?is subsection1 ! ,director ( ,,nih & ! directors ( ! national rese>* in/itutes & national c5t]s %all-- 7,a7 complete ! initial /rategic plan requir$ by p>agraphs 7#a7 & 7#b72 & 7,b7 make su* initial /rategic plan publicly available on ! website ( ! ,national ,in/itutes ( ,heal?4 7#e7 ,review2 updates 7,a7 ,progress reviews ,n less ?an annually1 ! ,director ( ,,nih1 9 consultation ) ! directors ( ! national rese>* in/itutes & national c5t]s1 %all conduct progress reviews = ea* /rategic focus area id5tifi$ "u p>agraph 7#a77;,a77ii74 7,b7 ,updates ,n lat] ?an ! end ( ! #e-ye> p]iod cov]$ by ! initial /rategic plan "u ?is subsection1 & e #e ye>s !reaft]1 ! ,director ( ,,nih1 9 consultation ) ! directors ( ! national rese>* in/itutes & national c5t]s1 /akehold]s 9 ! sci5tific field1 advocates1 & ! public at l>ge1 %all-- 7i7 conduct a review ( ! plan1 includ+ ea* /rategic focus area id5tifi$ "u p>agraph 7#b77;,b72 & 7ii7 update su* plan 9 accordance ) ?is section4 4 #ajbb4 ,increas+ acc\ntability at ! ,national ,in/itutes ( ,heal? 7a7 ,appo9tm5t & t]ms ( directors ( national rese>* in/itutes & national c5t]s ,subsection 7a7 ( section #dje ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bhd7 is am5d$ to read z foll[s3 7a7 ,appo9tm5t2 t]ms 7#a7 ,appo9tm5t ,! ,director ( ! ,national ,canc] ,in/itute %all be appo9t$ by ! ,presid5t & ! directors ( ! o!r national rese>* in/itutes1 z well z ! directors ( ! national c5t]s1 %all be appo9t$ by ! ,director ( ,,nih4 ,! directors ( ! national rese>* in/itutes1 z well z national c5t]s1 %all report directly to ! ,director ( ,,nih4 7#b7 ,t]ms 7,a7 ,9 g5]al ,! t]m ( (fice ( a director ( a national rese>* in/itute or national c5t] %all be #e ye>s4 7,b7 ,removal ,! director ( a national rese>* in/itute or national c5t] may be remov$ f (fice by ! ,director ( ,,nih prior to ! expiration ( su* director's #e-ye> t]m4 7,c7 ,reappo9tm5t ,at ! end ( ! t]m ( a director ( a national rese>* in/itute or national c5t]1 ! director may be reappo9t$4 ,!re is no limit on ! numb] ( t]ms a director may s]ve4 7,d7 ,vacancies ,if ! (fice ( a director ( a national rese>* in/itute or national c5t] becomes vacant be=e ! end ( su* director's t]m1 ! director appo9t$ to fill ! vacancy %all be appo9t$ = a #e-ye> t]m />t+ on ! date ( su* appo9tm5t4 7,e7 ,transitional provision ,ea* director ( a national rese>* in/itute or national c5t] s]v+ on ! date ( enactm5t ( ! #ba/ ,c5tury ,cures ,act is deem$ to be appo9t$ = a #e-ye> t]m "u ?is subsection />t+ on su* date ( enactm5t4 4 7b7 ,comp5sation to consultants or individual sci5ti/s ,section #bjb ( ! ,dep>tm5ts ( ,labor1 ,heal? & ,human ,s]vices1 & ,education1 & ,relat$ ,ag5cies ,appropriations ,act1 #aiic 7,public ,law #ajb-cid2 #db ,u4,s4,c4 #bch;f note7 is am5d$ by /rik+ portable /ructures2 & all t foll[s & ins]t+ portable /ructures44 7c7 ,review ( c]ta9 aw>ds by directors ,section #dje7;b7 ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bhd7;b77 is am5d$ by add+ at ! end ! foll[+3 7#c7 ,be=e an aw>d is made by a national rese>* in/itute or by a national c5t] = a grant = a rese>* program or project 7commonly ref]r$ to z an ,r-s]ies grant71 o!r ?an an aw>d con/itut+ a noncompet+ r5ewal ( su* grant1 or a noncompet+ adm9i/rative supplem5t to su* grant1 ! director ( su* national rese>* in/itute or national c5t]-- 7,a7 %all review & approve ! aw>d2 & 7,b7 %all take into consid]ation-- 7i7 ! mission ( ! national rese>* in/itute or national c5t] & ! sci5tific priorities id5tifi$ 9 ! /rategic plan "u section #djb7m72 & 7ii7 :e!r o!r ag5cies are fund+ programs or projects to accompli% ! same goal4 4 7d7 ,,iom /udy on duplication 9 ,f$]al biom$ical rese>* ,! ,secret>y ( ,heal? & ,human ,s]vices %all ent] into an arrangem5t ) ! ,in/itute ( ,m$ic9e ( ! ,national ,academies 7or1 if ! ,in/itute decl9es1 ano!r appropriate entity7 "u :i* ! ,in/itute 7or o!r appropriate entity7 n lat] ?an #b ye>s aft] ! date ( enactm5t ( ?is ,act w-- 7#a7 complete a /udy on ! ext5t to :i* biom$ical rese>* conduct$ or support$ by ,f$]al ag5cies is duplicative2 & 7#b7 submit a report to ! ,congress on ! results ( su* /udy1 includ+ recomm5dations on h[ to prev5t su* duplication4 #ajbc4 ,r$uc+ adm9i/rative burd5s ( rese>*]s 7a7 ,plan ,prep>ation & implem5tation ( measures ,to r$uce adm9i/rative burd5s ,! ,director ( ! ,national ,in/itutes ( ,heal? %all prep>e a plan1 includ+ "t frames1 & implem5t measures to r$uce ! adm9i/rative burd5s ( rese>*]s fund$ by ! ,national ,in/itutes ( ,heal?1 tak+ into acc\nt ! recomm5dations1 evaluations1 & plans rese>*$ by ! foll[+ entities3 7#a7 ,! ,sci5tific ,managem5t ,review ,bo>d4 7#b7 ,! ,national ,academy ( ,sci5ces4 7#c7 ,! #bjjg & #bjab ,faculty ,burd5 ,survey conduct$ by ,! ,f$]al ,demon/ration ,p>tn]%ip4 7#d7 ,relevant recomm5dations f ! ,rese>* ,bus9ess ,models ,work+ ,gr\p4 7b7 ,report ,n lat] ?an #b ye>s aft] ! date ( enactm5t ( ?is ,act1 ! ,director ( ! ,national ,in/itutes ( ,heal? %all submit to ,congress a report on ! ext5t to :i* ! ,director has implem5t$ measures pursuant to subsection 7a74 #ajbd4 ,exemption = ! ,national ,in/itutes ( ,heal? f ! ,pap]work ,r$uction ,act requirem5ts ,section #ceah7;c77#a7 ( title #dd1 ,unit$ ,/ates ,code1 is am5d$-- 7#a7 9 subp>agraph 7,c71 by /rik+ 2 or & ins]t+ a semicolon2 7#b7 9 subp>agraph 7,d71 by /rik+ ! p]iod at ! end & ins]t+ 2 or2 & 7#c7 by ins]t+ at ! end ! foll[+ new subp>agraph3 7,e7 dur+ ! conduct ( rese>* by ! ,national ,in/itutes ( ,heal?4 4 #ajbe4 ,,nih travel ,x is ! s5se ( ,congress t p>ticipation 9 or sponsor%ip ( sci5tific conf]5ces & meet+s is ess5tial to ! mission ( ! ,national ,in/itutes ( ,heal?4 #ajbf4 ,o!r transactions au?ority ,section #dhj ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bhg;a7 is am5d$-- 7#a7 9 subsection 7b71 by /rik+ ! appropriation ( funds z describ$ 9 subsection 7g7 & ins]t+ ! availability ( funds z describ$ 9 subsection 7f72 7#b7 9 subsection 7e77#c71 by am5d+ subp>agraph 7,c7 to read z foll[s3 7,c7 ,o!r ,transactions ,au?ority ,! ,director ( ! ,c5t] %all h o!r transactions au?ority 9 ent]+ into transactions to fund projects 9 accordance ) ! t]ms & conditions ( ?is section4 2 7#c7 by /rik+ subsection 7f72 & 7#d7 by r$esignat+ subsection 7g7 z subsection 7f74 #ajbg4 ,,ncats phase ,,iib re/riction ,section #dgi ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bhg7 is am5d$-- 7#a7 prior to mak+ ! am5dm5ts "u p>agraph 7#b71 by /rik+ ,,iib ea* place x appe>s & ins]t+ ,,iii2 & 7#b7 by /rik+ ,,iia ea* place x appe>s & ins]t+ ,,iib4 #ajbh4 ,high-risk1 high-rew>d rese>* ,"p ,b ( title ,,iv ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bhd et seq471 z am5d$ by section #ajjb ( ?is ,act1 is am5d$ by add+ at ! end ! foll[+3 #dji,l4 ,high-risk1 high-rew>d rese>* program ,! director ( ea* national rese>* in/itute %all1 z appropriate-- 7#a7 e/abli% programs to conduct or support rese>* projects t pursue innovative approa*es to major contempor>y *all5ges 9 biom$ical rese>* t involve inh]5t high risk1 b h ! pot5tial to lead to break?r\ghs2 & 7#b7 set aside a specific p]c5tage ( fund+1 to be det]m9$ by ! ,director ( ,,nih = ea* national rese>* in/itute1 = su* projects4 4 #ajbi4 ,s5se ( ,congress on increas$ inclusion ( und]repres5t$ communities 9 cl9ical trials ,x is ! s5se ( ,congress t ! ,national ,in/itute on ,m9ority ,heal? & ,heal? ,disp>ities 7,,nimhd7 %\ld include )9 its /rategic plan ways to increase repres5tation ( und]repres5t$ communities 9 cl9ical trials4 ,c ,support+ ,"y ,em]g+ ,sci5ti/s #ajda4 ,improvem5t ( loan repaym5t programs ( ! ,national ,in/itutes ( ,heal? 7a7 ,9 g5]al ,"p ,g ( title ,,iv ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bhh et seq47 is am5d$-- 7#a7 by r$esignat+ ! second section #dhg;,f 7#db ,u4,s4,c4 #bhh-f2 relat+ to p$iatric rese>* loan repaym5t program7 z section #dhg;,g2 & 7#b7 by ins]t+ aft] section #dhg;,g1 z s r$esignat$1 ! foll[+3 #dhg;,h4 ,loan repaym5t program 7a7 ,9 g5]al ,! ,secret>y %all e/abli% a program1 bas$ on work=ce & sci5tific ne$s1 ( ent]+ into contracts ) qualifi$ heal? pr(essionals "u :i* su* heal? pr(essionals agree to engage 9 rese>* 9 consid]ation ( ! ,f$]al ,gov]nm5t agree+ to pay1 = ea* ye> ( engag+ 9 su* rese>*1 n m ?an #ej1jjj ( ! pr9cipal & int]e/ ( ! educational loans ( su* heal? pr(essionals4 7b7 ,adju/m5t = inflation ,beg9n+ ) respect to fiscal ye> #bjag1 ! ,secret>y may increase ! maximum am\nt specifi$ 9 subsection 7a7 by an am\nt t is det]m9$ by ! ,secret>y1 on an annual basis1 to reflect inflation4 7c7 ,limitation ,! ,secret>y may n ent] into a contract ) a heal? pr(essional pursuant to subsection 7a7 unless su* pr(essional has a sub/antial am\nt ( educational loans relative to income4 7d7 ,applicability ( c]ta9 provisions reg>d+ obligat$ s]vice ,except to ! ext5t inconsi/5t ) ?is section1 ! provisions ( sections #cch;,b1 #cch;,c1 & #cch;,e %all apply to ! program e/abli%$ "u ?is section to ! same ext5t & 9 ! same mann] z su* provisions apply to ! ,national ,heal? ,s]vice ,corps ,loan ,repaym5t ,program e/abli%$ "u section #cch;,b4 7e7 ,availability ( appropriations ,am\nts appropriat$ = a fiscal ye> = contracts "u subsection 7a7 are au?oriz$ to rema9 available until ! expiration ( ! second fiscal ye> beg9n+ aft] ! fiscal ye> = :i* ! am\nts 7 appropriat$4 4 7b7 ,update ( o!r loan repaym5t programs 7#a7 ,section #dfdz-#e7;a7 ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4#bhet-#b7;a77 is am5d$-- 7,a7 by /rik+ #ce1jjj & ins]t+ #ej1jjj2 & 7,b7 by add+ at ! end ! foll[+ new s5t5ce3 ,subsection 7b7 ( section #dhg;,h %all apply ) respect to ! maximum am\nt specifi$ 9 ?is subsection 9 ! same mann] z x applies to ! maximum am\nt specifi$ 9 subsection 7a7 ( su* section44 7#b7 ,section #dhg;,a7a7 ( su* ,act 7#db ,u4,s4,c4 #bhh-a7;a77 is am5d$-- 7,a7 by /rik+ #ce1jjj & ins]t+ #ej1jjj2 & 7,b7 by add+ at ! end ! foll[+ new s5t5ce3 ,subsection 7b7 ( section #dhg;,h %all apply ) respect to ! maximum am\nt specifi$ 9 ?is subsection 9 ! same mann] z x applies to ! maximum am\nt specifi$ 9 subsection 7a7 ( su* section44 7#c7 ,section #dhg;,b7a7 ( su* ,act 7#db ,u4,s4,c4 #bhh-b7;a77 is am5d$-- 7,a7 by /rik+ #ce1jjj & ins]t+ #ej1jjj2 & 7,b7 by add+ at ! end ! foll[+ new s5t5ce3 ,subsection 7b7 ( section #dhg;,h %all apply ) respect to ! maximum am\nt specifi$ 9 ?is subsection 9 ! same mann] z x applies to ! maximum am\nt specifi$ 9 su* subsection 7a7 ( su* section44 7#d7 ,section #dhg;,c7a77#a7 ( su* ,act 7#db ,u4,s4,c4 #bhh-c7;a77#a77 is am5d$-- 7,a7 by /rik+ #ce1jjj & ins]t+ #ej1jjj2 & 7,b7 by add+ at ! end ! foll[+ new s5t5ce3 ,subsection 7b7 ( section #dhg;,h %all apply ) respect to ! maximum am\nt specifi$ 9 ?is p>agraph 9 ! same mann] z x applies to ! maximum am\nt specifi$ 9 su* subsection 7a7 ( su* section44 7#e7 ,section #dhg;,e7a77#a7 ( su* ,act 7#db ,u4,s4,c4 #bhh-e7;a77#a77 is am5d$-- 7,a7 by /rik+ #ce1jjj & ins]t+ #ej1jjj2 & 7,b7 by add+ at ! end ! foll[+ new s5t5ce3 ,subsection 7b7 ( section #dhg;,h %all apply ) respect to ! maximum am\nt specifi$ 9 ?is p>agraph 9 ! same mann] z x applies to ! maximum am\nt specifi$ 9 su* subsection 7a7 ( su* section44 7#f7 ,section #dhg;,f7a7 ( su* ,act 7#db ,u4,s4,c4 #bhh-e;a7a771 z add$ by section #bje ( ,public ,law #ajf-eje1 is am5d$-- 7,a7 by /rik+ #ce1jjj & ins]t+ #ej1jjj2 & 7,b7 by add+ at ! end ! foll[+ new s5t5ce3 ,subsection 7b7 ( section #dhg;,h %all apply ) respect to ! maximum am\nt specifi$ 9 ?is subsection 9 ! same mann] z x applies to ! maximum am\nt specifi$ 9 su* subsection 7a7 ( su* section44 7#g7 ,section #dhg;,g ( su* ,act 7#db ,u4,s4,c4 #bhh-f1 z r$esignat$ by subsection 7a77#a771 is fur!r am5d$-- 7,a7 9 subsection 7a77#a71 by /rik+ #ce1jjj & ins]t+ #ej1jjj2 & 7,b7 9 subsection 7b71 by add+ at ! end ! foll[+ new s5t5ce3 ,subsection 7b7 ( section #dhg;,h %all apply ) respect to ! maximum am\nt specifi$ 9 subsection 7a77#a7 9 ! same mann] z x applies to ! maximum am\nt specifi$ 9 su* subsection 7a7 ( su* section44 #ajdb4 ,report ,n lat] ?an #ah mon?s aft] ! date ( ! enactm5t ( ?is ,act1 ! ,director ( ! ,national ,in/itutes ( ,heal? %all submit to ,congress a report on ef=ts ( ! ,national ,in/itutes ( ,heal? to attract1 reta91 & develop em]g+ sci5ti/s1 includ+ und]repres5t$ individuals 9 ! sci5ces1 su* z wom5 & o!r m9orities4 ,d ,cap/one ,grant ,program #ajfa4 ,cap/one aw>d ,"p ,g ( title ,,iv ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bhh et seq47 is am5d$ by add+ at ! end ! foll[+3 #dij4 ,cap/one aw>d 7a7 ,9 g5]al ,! ,secret>y may make aw>ds 7ea* ( :i*1 h]eaft] 9 ?is section1 ref]r$ to z a ,cap/one ,aw>d7 to support out/&+ sci5ti/s :o h be5 fund$ by ! ,national ,in/itutes ( ,heal?4 7b7 ,purpose ,cap/one ,aw>ds %all be made to facilitate ! successful transition or conclusion ( rese>* programs1 or = o!r purposes1 z det]m9$ by ! ,director ( ,,nih1 9 consultation ) ! directors ( ! national rese>* in/itutes & national c5t]s4 7c7 ,duration & am\nt ,! duration & am\nt ( ea* ,cap/one ,aw>d %all be det]m9$ by ! ,director ( ,,nih 9 consultation ) ! directors ( ! national rese>* in/itutes & national c5t]s4 7d7 ,limitation ,individuals :o h receiv$ a ,cap/one ,aw>d %all n be eligible to h pr9ciple inve/igator /atus on subsequ5t aw>ds f ! ,national ,in/itutes ( ,heal?4 4 ,e ,promot+ ,p$iatric ,rese>* ?r\gh ! ,national ,in/itutes ( ,heal? #ajha4 ,national p$iatric rese>* network ,section #dji;,d7d7 ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bhd;h7d77 is am5d$-- 7#a7 9 p>agraph 7#a7-- 7,a7 by /rik+ 9 consultation ) ! ,director ( ! ,eunice ,k5n$y ,%riv] ,national ,in/itute ( ,*ild ,heal? & ,human ,developm5t & 9 collaboration ) o!r appropriate national rese>* in/itutes & national c5t]s t c>ry out activities involv+ p$iatric rese>* & ins]t+ 9 collaboration ) ! national rese>* in/itutes & national c5t]s t c>ry out activities involv+ p$iatric rese>*2 7,b7 by /rik+ subp>agraph 7,b72 7,c7 by /rik+ may be compris$ (1 z appropriate & all t foll[s ?r\gh ! p$iatric rese>* consortia & ins]t+ may be compris$ (1 z appropriate1 ! p$iatric rese>* consortia2 & 7,d7 by /rik+ 2 or at ! end & ins]t+ a p]iod2 & 7#b7 9 p>agraph 7#a71 p>agraph 7#b77;,a71 ! fir/ s5t5ce ( p>agraph 7#b77;,e71 & p>agraph 7#d71 by /rik+ may ea* place x appe>s & ins]t+ %all4 #ajhb4 ,global p$iatric cl9ical /udy network s5se ( ,congress ,x is ! s5se ( ,congress t-- 7#a7 ! ,national ,in/itutes ( ,heal? %\ld enc\rage a global p$iatric cl9ical /udy network ?r\gh ! allocation ( grants1 contracts1 or coop]ative agreem5ts to supplem5t ! sal>ies ( new & e>ly inve/igators :o p>ticipate 9 ! global p$iatric cl9ical /udy network2 7#b7 ,national ,in/itutes ( ,heal? grants1 contracts1 or coop]ative agreem5ts %\ld be aw>d$1 solely = ! purpose ( supplem5t+ ! sal>ies ( new & e>ly inve/igators1 to entities t p>ticipate 9 ! global p$iatric cl9ical /udy network2 7#c7 ! ,food & ,drug ,adm9i/ration %\ld engage ! ,european ,m$ic9es ,ag5cy & o!r =eign regulatory entities dur+ ! =mation ( ! global p$iatric cl9ical /udy network to enc\rage _! p>ticipation2 & 7#d7 once a global p$iatric cl9ical /udy network is e/abli%$ & becomes op]ational1 ! ,food & ,drug ,adm9i/ration %\ld cont9ue to engage ! ,european ,m$ic9es ,ag5cy & o!r =eign regulatory entities to enc\rage & facilitate _! p>ticipation 9 ! network ) ! goal ( enhanc+ ! global rea* ( ! network4 #ajhc4 ,appropriate age gr\p+s 9 cl9ical rese>* 7a7 ,input f exp]ts ,n lat] ?an #ahj days aft] ! date ( enactm5t ( ?is ,act1 ! ,director ( ! ,national ,in/itutes ( ,heal? %all conv5e a work%op ( exp]ts on p$iatrics & exp]ts on g]iatrics to provide input on-- 7#a7 appropriate age gr\p+s to be includ$ 9 rese>* /udies involv+ human subjects2 & 7#b7 acceptable sci5tific ju/ifications = exclud+ p>ticipants f a range ( age gr\ps f human subjects rese>* /udies4 7b7 ,guidel9es ,n lat] ?an #ahj days aft] ! conclusion ( ! work%op "u subsection 7a71 ! ,director ( ! ,national ,in/itutes ( ,heal? %all publi% guidel9es-- 7#a7 address+ ! consid]ation ( age z an inclusion v>iable 9 rese>* involv+ human subjects2 & 7#b7 id5tify+ crit]ia = ju/ifications = any age-relat$ exclusions 9 su* rese>*4 7c7 ,public availability ( f9d+s & conclusions ,! ,director ( ! ,national ,in/itutes ( ,heal? %all-- 7#a7 make ! f9d+s & conclusions result+ f ! work%op "u subsection 7a7 available to ! public on ! website ( ! ,national ,in/itutes ( ,heal?2 & 7#b7 n less ?an bi5nially1 disclose to ! public on su* website ! numb] ( *ildr5 includ$ 9 rese>* t is conduct$ or support$ by ! ,national ,in/itutes ( ,heal?1 disaggregat$ by developm5tally appropriate age gr\p1 race1 & g5d]4 ,f ,advancem5t ( ! ,national ,in/itutes ( ,heal? ,rese>* & ,data ,access #aaja4 ,/&>dization ( data 9 ,cl9ical ,trial ,regi/ry ,data ,bank on eligibility = cl9ical trials 7a7 ,/&>dization 7#a7 ,9 g5]al ,section #djb7;j7 ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bhb7;j77 is am5d$-- 7,a7 by r$esignat+ p>agraph 7#g7 z p>agraph 7#h72 & 7,b7 by ins]t+ aft] p>agraph 7#f7 ! foll[+3 7#g7 ,/&>dization ,! ,director ( ,,nih %all-- 7,a7 ensure t ! regi/ry & results data bank is easily us$ by ! public2 7,b7 ensure t entries 9 ! regi/ry & results data bank are easily comp>$2 7,c7 ensure t in=mation requir$ to be submitt$ to ! regi/ry & results data bank1 includ+ recruitm5t in=mation "u p>agraph 7#b77;,a77ii77,,ii71 is submitt$ by p]sons & po/$ by ! ,director ( ,,nih 9 a /&>diz$ =mat & includes at lea/-- 7i7 ! disease or indication be+ /udi$2 7ii7 inclusion crit]ia su* z age1 g5d]1 diagnosis or diagnoses1 laboratory values1 or imag+ results2 & 7iii7 exclusion crit]ia su* z specific diagnosis or diagnoses1 laboratory values1 or prohibit$ m$ications2 & 7,d7 to ! ext5t possible1 9 c>ry+ out ?is p>agraph1 make use ( /&>d heal? c>e t]m9ologies1 su* z ! ,int]national ,classification ( ,diseases or ! ,curr5t ,proc$ural ,t]m9ology1 t facilitate electronic mat*+ to data 9 electronic heal? records or o!r relevant heal? in=mation te*nologies4 4 7#b7 ,con=m+ am5dm5t ,clause 7iv7 ( section #djb7;j77#b77;,b7 ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bhb7;j77#b77;,b77 is h]eby /rick54 7b7 ,consultation ,n lat] ?an #ij days aft] ! date ( enactm5t ( ?is ,act1 ! ,secret>y ( ,heal? & ,human ,s]vices %all consult ) /akehold]s 7includ+ pati5ts1 rese>*]s1 physicians1 indu/ry repres5tatives1 heal? in=mation te*nology provid]s1 ! ,food & ,drug ,adm9i/ration1 & /&>d sett+ organizations su* z ,,cdisc t h exp]i5ce work+ ) ,f$]al ag5cies to /&>dize heal? data submissions7 to receive advice on enhancem5ts to ! cl9ical trial regi/ry data bank "u section #djb7;j7 ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bhb7;j77 7includ+ enhancem5ts to usability1 functionality1 & se>* capability7 t are necess>y to implem5t p>agraph 7#g7 ( section #djb7;j7 ( su* ,act1 z add$ by subsection 7a74 7c7 ,applicability ,n lat] ?an #ah mon?s aft] ! date ( enactm5t ( ?is ,act1 ! ,secret>y ( ,heal? & ,human ,s]vices %all beg9 implem5tation ( p>agraph 7#g7 ( section #djb7;j7 ( ! ,public ,heal? ,s]vice ,act1 z add$ by subsection 7a74 ,g ,facilitat+ ,collaborative ,rese>* #aaba4 ,cl9ical trial data sy/em 7a7 ,e/abli%m5t ,! ,secret>y1 act+ ?r\gh ! ,commission] ( ,food & ,drugs & ! ,director ( ! ,national ,in/itutes ( ,heal?1 %all ent] into a coop]ative agreem5t1 contract1 or grant = a p]iod ( #g ye>s1 to be kn[n z ! ,cl9ical ,trial ,data ,sy/em ,agreem5t1 ) "o or m eligible entities to implem5t a pilot program ) respect to all cl9ical trial data obta9$ f qualifi$ cl9ical trials = purposes ( regi/]$ us]s conduct+ fur!r rese>* on su* data4 7b7 ,application ,eligible entities seek+ to ent] into a coop]ative agreem5t1 contract1 or grant ) ! ,secret>y "u ?is section %all submit to ! ,secret>y an application 9 su* "t & mann]1 & conta9+ su* in=mation1 z ! ,secret>y may require 9 accordance ) ?is section4 ,! ,secret>y %all n ent] into a coop]ative agreem5t1 contract1 or grant "u ?is section ) an eligible entity unless su* entity submits an application includ+ ! foll[+3 7#a7 ,a c]tification t ! eligible entity is n curr5tly & does n plan to be involv$ 9 sponsor+1 op]at+1 or p>ticipat+ 9 a cl9ical trial nor collaborat+ ) ano!r entity = ! purposes ( sponsor+1 op]at+1 or p>ticipat+ 9 a cl9ical trial4 7#b7 ,in=mation demon/rat+ t ! eligible entity c compile cl9ical trial data 9 /&>diz$ =mats us+ t]m9ologies & /&>ds t h be5 develop$ by recogniz$ /&>ds develop+ organizations ) input f div]se /akehold] gr\ps1 & in=mation demon/rat+ t ! eligible entity c de-id5tify cl9ical trial data consi/5t ) ! requirem5ts ( section #afd4ead ( title #de1 ,code ( ,f$]al ,regulations 7or successor regulations74 7#c7 ,a description ( ! sy/em ! eligible entity w use to /ore & ma9ta9 su* data1 & in=mation demon/rat+ t ?is sy/em w comply ) applicable /&>ds & requirem5ts = ensur+ ! security ( ! cl9ical trial data4 7#d7 ,a c]tification t ! eligible entity w all[ only regi/]$ us]s to access & use de-id5tifi$ cl9ical trial data1 ga!r$ f qualifi$ cl9ical trials1 & t ! eligible entity w all[ ea* regi/]$ us] to access & use su* data only aft] su* regi/]$ us] agrees 9 writ+ to ! t]ms describ$ 9 7e77#d77;,b71 & su* o!r c>efully controll$ contractual t]ms z may be def9$ by ! ,secret>y4 7#e7 ,evid5ce demon/rat+ ! ability ( ! eligible entity to ensure t regi/]$ us]s dissem9ate ! results ( ! rese>* conduct$ 9 accordance ) ?is section to int]e/$ p>ties to s]ve z a guide to future m$ical product developm5t or sci5tific rese>*4 7#f7 ,! plan ( ! eligible entity = secur+ fund+ = ! activities x w\ld conduct "u ! cl9ical trial data sy/em agreem5t f gov]nm5tal s\rces & private f\ndations1 entities1 & individuals4 7#g7 ,evid5ce demon/rat+ a prov5 track record (-- 7,a7 be+ a neutral ?ird p>ty 9 work+ ) m$ical product manufactur]s1 academic in/itutions1 & ! ,food & ,drug ,adm9i/ration2 & 7,b7 hav+ ! ability to protect confid5tial data4 7#h7 ,an agreem5t t ! eligible entity w "w ) ! ,comptroll] ,g5]al ( ! ,unit$ ,/ates = purposes ( ! /udy & report "u subsection 7d74 7c7 ,ext5sion1 expansion1 t]m9ation ,! ,secret>y1 act+ ?r\gh ! ,commission] ( ,food & ,drugs & ! ,director ( ! ,national ,in/itutes ( ,heal?1 ^u ! expiration ( ! #g-ye> p]iod ref]r$ to 9 subsection 7a71 may ext5d 7includ+ p]man5tly71 exp&1 or t]m9ate ! pilot program e/abli%$ "u su* subsection1 9 :ole or 9 "p4 7d7 ,/udy & report 7#a7 ,9 g5]al ,! ,comptroll] ,g5]al ( ! ,unit$ ,/ates %all conduct a /udy & issue a report to ! ,congress & ! ,secret>y ) respect to ! pilot program e/abli%$ "u subsection 7a71 n lat] ?an #f ye>s aft] ! date on :i* ! pilot program is e/abli%$ "u subsection 7a74 7#b7 ,/udy ,! /udy "u p>agraph 7#a7 %all-- 7,a7 review ! effectiv5ess ( ! pilot program e/abli%$ "u subsection 7a72 & 7,b7 be design$ to =mulate recomm5dations on improvem5ts to ! program4 7#c7 ,report ,! report "u p>agraph 7#a7 %all conta9 at lea/ ! foll[+ in=mation3 7,a7 ,! new discov]ies1 rese>* inquiries1 or cl9ical trials t h result$ f access+ cl9ical trial data "u ! pilot program e/abli%$ "u subsection 7a74 7,b7 ,! numb] ( times sci5ti/s h access$ su* data1 disaggregat$ by rese>* area & cl9ical trial phase4 7,c7 ,an analysis ( :e!r ! program has help$ to r$uce adv]se ev5ts 9 cl9ical trials4 7,d7 ,an analysis ( :e!r sci5ti/s h rais$ any conc]ns ab\t ! burd5 ( hav+ to %>e data ) ! sy/em e/abli%$ "u ! program &1 if s1 a description ( su* conc]ns4 7,e7 ,an analysis ( privacy & data integrity practices us$ 9 ! program4 7e7 ,def9itions ,9 ?is section3 7#a7 ,! t]m eligible entity means an entity t has exp]i5c$ p]sonnel ) cl9ical & o!r te*nical exp]tise 9 ! biom$ical sci5ces & biom$ical e?ics & t is-- 7,a7 an in/itution ( high] education 7z su* t]m is def9$ 9 section #ajja ( ! ,high] ,education ,act ( #aife 7#bj ,u4,s4,c4 #ajja77 or a consortium ( su* in/itutions2 or 7,b7 an organization describ$ 9 section #eja7;c77#c7 ( title #bf ( ! ,int]nal ,rev5ue ,code ( #aihf & exempt f tax "u section #eja7;a7 ( su* title4 7#b7 ,! t]m m$ical product means a drug 7z def9$ 9 section #bja7;g7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cca7;g7771 a device 7z def9$ 9 section #bja7;h7 ( su* ,act 7#ba ,u4,s4,c4 #cca7;h771 a biological product 7z def9$ 9 section #cea ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bfb771 or any comb9ation !re(4 7#c7 ,! t]m qualifi$ cl9ical trial means a cl9ical trial sponsor$ solely by an ag5cy ( ! ,dep>tm5t ( ,heal? & ,human ,s]vices ) respect to a m$ical product-- 7,a7 t-- 7i7 0 approv$ or cle>$ "u section #eje1 #eaj7k71 or #eae1 or has an exemption = inve/igational use 9 effect "u section #eje or #ebj7m71 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#db ,u4,s4,c4 #cja et seq472 or 7ii7 0 lic5s$ "u section #cea ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bfb7 or has an exemption = inve/igational use 9 effect "u su* section #cea2 or 7,b7 t is an inve/igational product = :i* ! orig9al developm5t 0 discont9u$ & ) respect to :i*-- 7i7 no additional "w to support approval1 lic5sure1 or cle>ance ( su* m$ical product is be+ or is plann$ to be und]tak5 by ! sponsor ( ! orig9al developm5t program1 its successors1 assigns1 or collaborators2 & 7ii7 ! sponsor ( ! orig9al inve/igational developm5t program has provid$ its cons5t to ! ,secret>y = inclusion ( data reg>d+ su* product 9 ! sy/em e/abli%$ "u ?is section4 7#d7 ,! t]m regi/]$ us] means a sci5tific or m$ical rese>*] :o has-- 7,a7 a legitimate biom$ical rese>* purpose = access+ in=mation f ! cl9ical trials data sy/em & has appropriate qualifications to conduct su* rese>*2 & 7,b7 agre$ 9 writ+ n to transf] to any o!r p]son t is n a regi/]$ us] de-id5tifi$ cl9ical trial data f qualifi$ cl9ical trials access$ ?r\gh an eligible entity1 use su* data = reasons n specifi$ 9 ! rese>* proposal1 or seek to re-id5tify qualifi$ cl9ical trial p>ticipants4 7#e7 ,! t]m ,secret>y means ! ,secret>y ( ,heal? & ,human ,s]vices4 #aabb4 ,national neurological diseases surveillance sy/em ,"p ,p ( title ,,iii ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bhj;g et seq47 is am5d$ by add+ at ! end ! foll[+3 #cii,v-#f ,surveillance ( neurological diseases 7a7 ,9 g5]al ,! ,secret>y1 act+ ?r\gh ! ,director ( ! ,c5t]s = ,disease ,control & ,prev5tion & 9 coord9ation ) o!r ag5cies z det]m9$ appropriate by ! ,secret>y1 %all-- 7#a7 enhance & exp& infra/ructure & activities to track ! epidemiology ( neurological diseases1 includ+ multiple scl]osis & ,p>k9son's disease2 & 7#b7 incorporate in=mation obta9$ ?r\gh su* activities into a /ati/ically s\nd1 sci5tifically cr$ible1 integrat$ surveillance sy/em1 to be kn[n z ! ,national ,neurological ,diseases ,surveillance ,sy/em4 7b7 ,rese>* ,! ,secret>y %all ensure t ! ,national ,neurological ,diseases ,surveillance ,sy/em is design$ 9 a mann] t facilitates fur!r rese>* on neurological diseases4 7c7 ,cont5t ,9 c>ry+ out subsection 7a71 ! ,secret>y-- 7#a7 %all provide = ! collection & /orage ( in=mation on ! incid5ce & preval5ce ( neurological diseases 9 ! ,unit$ ,/ates2 7#b7 to ! ext5t practicable1 %all provide = ! collection & /orage ( o!r available in=mation on neurological diseases1 su* z in=mation conc]n+-- 7,a7 demographics & o!r in=mation associat$ or possibly associat$ ) neurological diseases1 su* z age1 race1 e?nicity1 sex1 geographic location1 & family hi/ory2 7,b7 risk factors associat$ or possibly associat$ ) neurological diseases1 includ+ g5etic & environm5tal risk factors2 & 7,c7 diagnosis & progression m>k]s2 7#c7 may provide = ! collection & /orage ( in=mation relevant to analysis on neurological diseases1 su* z in=mation conc]n+-- 7,a7 ! epidemiology ( ! diseases2 7,b7 ! natural hi/ory ( ! diseases2 7,c7 ! prev5tion ( ! diseases2 7,d7 ! detection1 managem5t1 & treatm5t approa*es = ! diseases2 & 7,e7 ! developm5t ( outcomes measures2 & 7#d7 may address issues id5tifi$ dur+ ! consultation process "u subsection 7d74 7d7 ,consultation ,9 c>ry+ out ?is section1 ! ,secret>y %all consult ) individuals ) appropriate exp]tise1 includ+-- 7#a7 epidemiologi/s ) exp]i5ce 9 disease surveillance or regi/ries2 7#b7 repres5tatives ( national volunt>y heal? associations t-- 7,a7 focus on neurological diseases1 includ+ multiple scl]osis & ,p>k9son's disease2 & 7,b7 h demon/rat$ exp]i5ce 9 rese>*1 c>e1 or pati5t s]vices2 7#c7 heal? in=mation te*nology exp]ts or o!r in=mation managem5t speciali/s2 7#d7 cl9icians ) exp]tise 9 neurological diseases2 & 7#e7 rese>* sci5ti/s ) exp]i5ce conduct+ translational rese>* or utiliz+ surveillance sy/ems = sci5tific rese>* purposes4 7e7 ,grants ,! ,secret>y may aw>d grants to1 or ent] into contracts or coop]ative agreem5ts )1 public or private nonpr(it entities to c>ry out activities "u ?is section4 7f7 ,coord9ation ) o!r ,f$]al1 ,/ate1 & local ag5cies ,subject to subsection 7h71 ! ,secret>y %all make in=mation & analysis 9 ! ,national ,neurological ,diseases ,surveillance ,sy/em available1 z appropriate-- 7#a7 to ,f$]al dep>tm5ts & ag5cies1 su* z ! ,national ,in/itutes ( ,heal?1 ! ,food & ,drug ,adm9i/ration1 ! ,c5t]s = ,m$ic>e ,m$icaid ,s]vices1 ! ,ag5cy = ,heal?c>e ,rese>* & ,quality1 ! ,dep>tm5t ( ,vet]ans ,affairs1 & ! ,dep>tm5t ( ,def5se2 & 7#b7 to ,/ate & local ag5cies4 7g7 ,public access ,subject to subsection 7h71 ! ,secret>y %all make in=mation & analysis 9 ! ,national ,neurological ,diseases ,surveillance ,sy/em available1 z appropriate1 to ! public1 includ+ rese>*]s4 7h7 ,privacy ,! ,secret>y %all ensure t privacy & security protections applicable to ! ,national ,neurological ,diseases ,surveillance ,sy/em are at lea/ z /r+5t z ! privacy & security protections "u ,,hipaa privacy & security law 7z def9$ 9 section #cjji7;a77#b774 7i7 ,report ,n lat] ?an #d ye>s aft] ! date ( ! enactm5t ( ?is section1 ! ,secret>y %all submit a report to ! ,congress conc]n+ ! implem5tation ( ?is section4 ,su* report %all include in=mation on-- 7#a7 ! developm5t & ma9t5ance ( ! ,national ,neurological ,diseases ,surveillance ,sy/em2 7#b7 ! type ( in=mation collect$ & /or$ 9 ! ,sy/em2 7#c7 ! use & availability ( su* in=mation1 includ+ guidel9es = su* use2 & 7#d7 ! use & coord9ation ( databases t collect or ma9ta9 in=mation on neurological diseases4 7j7 ,def9ition ,9 ?is section1 ! t]m national volunt>y heal? association means a national nonpr(it organization ) *apt]s1 o!r affiliat$ organizations1 or networks 9 ,/ates ?r\gh\t ! ,unit$ ,/ates4 7k7 ,au?orization ( appropriations ,to c>ry out ?is section1 !re is au?oriz$ to be appropriat$ #e1jjj1jjj = ea* ( fiscal ye>s #bjaf ?r\gh #bjbj4 4 #aabc4 ,data on natural hi/ory ( diseases 7a7 ,s5se ( ,congress ,x is ! s5se ( ! ,congress t /udies on ! natural hi/ory ( diseases c help to facilitate & exp$ite ! developm5t ( m$ical products = su* diseases4 7b7 ,au?ority ,"p ,a ( title ,,ii ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bjb et seq47 is am5d$ by add+ at ! end ! foll[+3 #bbi;,a4 ,data on natural hi/ory ( diseases 7a7 ,9 g5]al ,! ,secret>y1 act+ ?r\gh ! ,commission] ( ,food & ,drugs1 may1 = ! purposes describ$ 9 subsection 7b7-- 7#a7 p>ticipate 9 public-private p>tn]%ips engag$ 9 "o or m activities specifi$ 9 subsection 7c72 & 7#b7 aw>d grants to pati5t advocacy gr\ps or o!r organizations det]m9$ appropriate by ! ,secret>y4 7b7 ,purposes describ$ ,! purposes describ$ 9 ?is subsection are to e/abli% or facilitate ! collection1 ma9t5ance1 analysis1 & int]pretation ( data reg>d+ ! natural hi/ory ( diseases1 ) a p>ticul> focus on r>e diseases4 7c7 ,activities ( public-,private p>tn]%ips ,! activities ( public-private p>tn]%ips 9 :i* ! ,secret>y may p>ticipate = purposes ( ?is section include-- 7#a7 coop]at+ ) o!r entities t sponsor or ma9ta9 disease regi/ries1 includ+ disease regi/ries & disease regi/ry plat=ms = r>e diseases2 7#b7 develop+ or enhanc+ a secure in=mation te*nology sy/em t-- 7,a7 has ! capacity to support data ne$s across a wide range ( disease /udies2 7,b7 is easily modifi$ z k is ga9$ dur+ su* /udies2 & 7,c7 is capable ( h&l+ increas+ am\nts ( data z m /udies are c>ri$ out2 & 7#c7 provid+ advice to cl9ical rese>*]s1 pati5t advocacy gr\ps1 & o!r entities ) respect to-- 7,a7 ! design & conduct ( disease /udies2 7,b7 ! modification ( any su* ongo+ /udies2 & 7,c7 address+ associat$ pati5t privacy issues4 7d7 ,availability ( data on natural hi/ory ( diseases ,data relat+ to ! natural hi/ory ( diseases obta9$1 aggregat$1 or o!rwise ma9ta9$ by a public-private p>tn]%ip 9 :i* ! ,secret>y p>ticipates "u subsection 7a7 %all be made available1 consi/5t ) o!rwise applicable ,f$]al & ,/ate privacy laws1 to ! public 7includ+ pati5t advocacy gr\ps1 rese>*]s1 & drug develop]s7 to help to facilitate & exp$ite m$ical product developm5t programs4 7e7 ,confid5tiality ,not)/&+ subsection 7d71 no?+ 9 ?is section au?orizes ! disclosure ( any in=mation t is a trade secret or comm]cial or f9ancial in=mation t is privileg$ or confid5tial & subject to section #eeb7;b77#d7 ( title #e1 ,unit$ ,/ates ,code1 or section #aije ( title #ah1 ,unit$ ,/ates ,code4 7f7 ,au?orization ( appropriations ,!re is au?oriz$ to be appropriat$ to c>ry out ?is section #e1jjj1jjj = ea* ( fiscal ye>s #bjaf ?r\gh #bjbj4 4 #aabd4 ,access+1 %>+1 & us+ heal? data = rese>* purposes 7a7 ,9 g5]al 7#a7 ,! ,,hite* ,act 7title ,,xiii ( division ,a ( ,public ,law #aaa-e7 is am5d$ by add+ at ! end ( subtitle ,d ( su* ,act 7#db ,u4,s4,c4 #agiba et seq47 ! foll[+3 #d ,access+1 %>+1 & us+ heal? data = rese>* purposes #acdda4 ,ref]5ces ,9 ?is "p3 7#a7 ,! rule ,ref]5ces to ! ,rule ref] to "p #afj or "p #afd1 z appropriate1 ( title #de1 ,code ( ,f$]al ,regulations 7or any successor regulation74 7#b7 ,"p #afd ,ref]5ces to a specifi$ section ( "p #afd1 ref] to su* specifi$ section ( "p #afd ( title #de1 ,code ( ,f$]al ,regulations 7or any successor section74 #acddb4 ,def9+ heal? data rese>* z "p ( heal? c>e op]ations 7a7 ,9 g5]al ,subject to subsection 7b71 ! ,secret>y %all revise or cl>ify ! ,rule to all[ ! use & disclosure ( protect$ heal? in=mation by a cov]$ entity = rese>* purposes1 includ+ /udies ^: purpose is to obta9 g5]alizable k1 to be treat$ z ! use & disclosure ( su* in=mation = heal? c>e op]ations describ$ 9 subp>agraph 7#a7 ( ! def9ition ( heal? c>e op]ations 9 section #afd4eja ( "p #afd4 7b7 ,modifications to rules = disclosures = heal? c>e op]ations ,9 apply+ section #afd4ejf ( "p #afd to ! disclosure ( protect$ heal? in=mation describ$ 9 subsection 7a7-- 7#a7 ! ,secret>y %all revise or cl>ify ! ,rule s t ! disclosure may be made by ! cov]$ entity to only-- 7,a7 ano!r cov]$ entity = heal? c>e op]ations 7z def9$ 9 section #afd4eja ( "p #afd72 7,b7 a bus9ess associate t has ent]$ into a contract "u section #afd4ejd7;e7 ( "p #afd ) a disclos+ cov]$ entity to p]=m heal? c>e op]ations2 or 7,c7 a bus9ess associate t has ent]$ into a contract "u section #afd4ejd7;e7 ( "p #afd = ! purpose ( data aggregation 7z def9$ 9 section #afd4eja ( "p #afd72 & 7#b7 ! ,secret>y %all fur!r revise or cl>ify ! ,rule s t ! limitation specifi$ by section #afd4ejf7;c77#d7 ( "p #afd does n apply to disclosures t are describ$ by subsection 7a74 7c7 ,rule ( con/ruction ,?is section %all n be con/ru$ z prohibit+ or re/rict+ a use or disclosure ( protect$ heal? in=mation = rese>* purposes t is o!rwise p]mitt$ "u "p #afd4 #acddc4 ,treat+ disclosures ( protect$ heal? in=mation = rese>* simil>ly to disclosures ( su* in=mation = public heal? purposes 7a7 ,remun]ation ,! ,secret>y %all revise or cl>ify ! ,rule s t disclosures ( protect$ heal? in=mation = rese>* purposes are n subject to ! limitation on remun]ation describ$ 9 section #afd4ejb7;a77#e77;ii77,b77#b77;ii7 ( "p #afd4 7b7 ,p]mitt$ uses & disclosures ,! ,secret>y %all revise or cl>ify ! ,rule s t rese>* activities1 includ+ comp>ative rese>* activities1 relat$ to ! quality1 safety1 or effectiv5ess ( a product or activity t is regulat$ by ! ,food & ,drug ,adm9i/ration are includ$ z public heal? activities = purposes ( :i* a cov]$ entity may disclose protect$ heal? in=mation to a p]son describ$ 9 section #afd4eab7;b77#a77;iii7 ( "p #afd4 #acddd4 ,p]mitt+ remote access to protect$ heal? in=mation by rese>*]s ,! ,secret>y %all revise or cl>ify ! ,rule s t subp>agraph 7,b7 ( section #afd4eab7;i77#a77;ii7 ( "p #afd 7prohibit+ ! removal ( protect$ heal? in=mation by a rese>*]7 does n prohibit remote access to heal? in=mation by a rese>*] s long z-- 7#a7 appropriate security & privacy safegu>ds are ma9ta9$ by ! cov]$ entity & ! rese>*]2 & 7#b7 ! protect$ heal? in=mation is n copi$ or o!rwise reta9$ by ! rese>*]4 #acdde4 ,all[+ "o-"t au?orization ( use & disclosure ( protect$ heal? in=mation = rese>* purposes 7a7 ,9 g5]al ,! ,secret>y %all revise or cl>ify ! ,rule to specify t an au?orization = ! use or disclosure ( protect$ heal? in=mation1 ) respect to an individual1 = future rese>* purposes %all be deem$ to conta9 a suffici5t description ( ! purpose ( ! use or disclosure if ! au?orization-- 7#a7 suffici5tly describes ! purposes su* t x w\ld be reasonable = ! individual to expect t ! protect$ heal? in=mation c\ld be us$ or disclos$ = su* future rese>*2 7#b7 ei!r-- 7,a7 /ates t ! au?orization w expire on a p>ticul> date or on ! occurr5ce ( a p>ticul> ev5t2 or 7,b7 /ates t ! au?orization w rema9 valid unless & until x is revok$ by ! individual2 & 7#c7 provides in/ruction to ! individual on h[ to revoke su* au?orization at any "t4 7b7 ,revocation ( au?orization ,! ,secret>y %all revise or cl>ify ! ,rule to specify t1 if an individual revokes an au?orization = future rese>* purposes su* z is describ$ by subsection 7a71 ! cov]$ entity may n make any fur!r uses or disclosures bas$ on t au?orization1 except1 z provid$ 9 p>agraph 7b77#e7 ( section #afd4ejh ( "p #afd1 to ! ext5t t ! cov]$ entity has tak5 action 9 reliance on ! au?orization4 4 7#b7 ,! table ( sections 9 section #acjja7;b7 ( su* ,act is am5d$ by add+ at ! end ( ! items relat+ to subtitle ,d ! foll[+ new items3 ,"p #d--;,access+1 ,%>+1 & ,us+ ,heal? ,data = ,rese>* ,purposes ,sec4 #acdda4 ,ref]5ces4 ,sec4 #acddb4 ,def9+ heal? data rese>* z "p ( heal? c>e op]ations4 ,sec4 #acddc4 ,treat+ disclosures ( protect$ heal? in=mation = rese>* simil>ly to disclosures ( su* in=mation = public heal? purposes4 ,sec4 #acddd4 ,p]mitt+ remote access to protect$ heal? in=mation by rese>*]s4 ,sec4 #acdde4 ,all[+ "o-"t au?orization ( use & disclosure ( protect$ heal? in=mation = rese>* purposes4 4 7b7 ,revision ( regulations ,n lat] ?an #ab mon?s aft] ! date ( ! enactm5t ( ?is ,act1 ! ,secret>y ( ,heal? & ,human ,s]vices %all revise & cl>ify ! provisions ( title #de1 ,code ( ,f$]al ,regulations1 = consi/5cy ) "p #d ( subtitle ,d ( ! ,,hite* ,act1 z add$ by subsection 7a74 ,h ,c\ncil = #ba/ ,c5tury ,cures #aada4 ,c\ncil = #ba/ ,c5tury ,cures ,title ,,ii ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bjb et seq47 is am5d$ by add+ at ! end ! foll[+3 ,e ,c\ncil = #ba/ ,c5tury ,cures #bha4 ,e/abli%m5t ,a nonpr(it corporation to be kn[n z ! ,c\ncil = #ba/ ,c5tury ,cures 7ref]r$ to 9 ?is "p z ! ,c\ncil7 %all be e/abli%$ 9 accordance ) ?is section4 ,! ,c\ncil %all be a public-private p>tn]%ip head$ by an ,executive ,director 7ref]r$ to 9 ?is "p z ! ,executive ,director71 appo9t$ by ! memb]s ( ! ,bo>d ( ,directors4 ,! ,c\ncil %all n be an ag5cy or in/rum5tality ( ! ,unit$ ,/ates ,gov]nm5t4 #bha;,a4 ,purpose ,! purpose ( ! ,c\ncil is to accel]ate ! discov]y1 developm5t1 & deliv]y 9 ! ,unit$ ,/ates ( innovative cures1 treatm5ts1 & prev5tive measures = pati5ts4 #bha;,b4 ,duties ,= ! purpose describ$ 9 section #bha;,a1 ! ,c\ncil %all-- 7#a7 fo/] collaboration & coord9ation among ! entities t comprise ! ,c\ncil1 includ+ academia1 gov]nm5t ag5cies1 indu/ry1 heal? c>e payors & provid]s1 pati5t advocates1 & o!rs engag$ 9 ! cycle ( discov]y1 developm5t1 & deliv]y ( life-sav+ & heal?-enhanc+ innovative int]v5tions2 7#b7 und]take communication & dissem9ation activities2 7#c7 publi% in=mation on ! activities fund$ "u section #bha;,d2 7#d7 e/abli% a /rategic ag5da = accel]at+ ! discov]y1 developm5t1 & deliv]y 9 ! ,unit$ ,/ates ( innovative cures1 treatm5ts1 & prev5tive measures = pati5ts2 7#e7 id5tify gaps & opportunities )9 & across ! discov]y1 developm5t1 & deliv]y cycle2 7#f7 develop & propose recomm5dations bas$ on ! gaps & opportunities s id5tifi$2 7#g7 facilitate ! int]op]ability ( ! compon5ts ( ! discov]y1 developm5t1 & deliv]y cycle2 7#h7 propose recomm5dations t w facilitate precompetitive collaboration2 7#i7 id5tify opportunities to "w )1 b n duplicate ! ef=ts (1 nonpr(it organizations & o!r public-private p>tn]%ips2 & 7#aj7 id5tify opportunities = collaboration ) organizations op]at+ outside ( ! ,unit$ ,/ates1 su* z ! ,innovative ,m$ic9es ,initiative ( ! ,european ,union4 #bha;,c4 ,organization2 adm9i/ration 7a7 ,bo>d ( directors 7#a7 ,e/abli%m5t 7,a7 ,9 g5]al ,! ,c\ncil %all h a ,bo>d ( ,directors 79 ?is "p ref]r$ to z ! ,bo>d ( ,directors71 :i* %all be compos$ ( ! ex (ficio memb]s "u subp>agraph 7,b7 & ! appo9t$ memb]s "u subp>agraph 7,c74 ,all memb]s ( ! ,bo>d %all be vot+ memb]s4 7,b7 ,ex (ficio memb]s ,! ex (ficio memb]s ( ! ,bo>d %all be ! foll[+ individuals or _! designees3 7i7 ,! ,director ( ! ,national ,in/itutes ( ,heal?4 7ii7 ,! ,commission] ( ,food & ,drugs4 7iii7 ,! ,adm9i/rator ( ! ,c5t]s = ,m$ic>e ,m$icaid ,s]vices4 7iv7 ,! heads ( five o!r ,f$]al ag5cies deem$ by ! ,secret>y to be engag$ 9 biom$ical rese>* & developm5t4 7,c7 ,appo9t$ memb]s ,! appo9t$ memb]s ( ! ,bo>d %all consi/ ( #ag individuals1 ( :om-- 7i7 eight %all be appo9t$ by ! ,comptroll] ,g5]al ( ! ,unit$ ,/ates f a li/ ( nom9ations submitt$ by lead+ trade associations-- 7,i7 f\r ( :om %all be repres5tatives ( ! bioph>maceutical indu/ry2 7,,ii7 two ( :om %all be repres5tatives ( ! m$ical device indu/ry2 & 7,,iii7 two ( :om %all be repres5tatives ( ! in=mation & digital te*nology indu/ry2 & 7ii7 n9e %all be appo9t$ by ! ,comptroll] ,g5]al ( ! ,unit$ ,/ates1 aft] solicit+ nom9ations-- 7,i7 two ( :om %all be repres5tatives ( academic rese>*]s2 7,,ii7 ?ree ( :om %all be repres5tatives ( pati5ts2 7,,iii7 two ( :om %all be repres5tatives ( heal? c>e provid]s2 & 7,,iv7 two ( :om %all be repres5tatives ( heal? c>e plans & insur]s4 7,d7 ,*air ,! ,*air ( ! ,bo>d %all be select$ by ! memb]s ( ! ,bo>d by majority vote f among ! memb]s ( ! ,bo>d4 7#b7 ,t]ms & vacancies 7,a7 ,9 g5]al ,! t]m ( (fice ( ea* memb] ( ! ,bo>d appo9t$ "u p>agraph 7#a77;,c7 %all be #e ye>s4 7,b7 ,vacancy ,any vacancy 9 ! memb]%ip ( ! ,bo>d-- 7i7 %all n affect ! p[] ( ! rema9+ memb]s to execute ! duties ( ! ,bo>d2 & 7ii7 %all be fill$ by appo9tm5t by ! appo9t$ memb]s describ$ 9 p>agraph 7#a77;,c7 by majority vote4 7,c7 ,p>tial t]m ,if a memb] ( ! ,bo>d does n s]ve ! full t]m applicable "u subp>agraph 7,a71 ! individual appo9t$ "u subp>agraph 7,b7 to fill ! result+ vacancy %all be appo9t$ = ! rema9d] ( ! t]m ( ! pr$ecessor ( ! individual4 7#c7 ,responsibilities ,n lat] ?an #ij days aft] ! date on :i* ! ,c\ncil is incorporat$ & its ,bo>d ( ,directors is fully con/itut$1 ! ,bo>d ( ,directors %all e/abli% bylaws & policies = ! ,c\ncil t-- 7,a7 are publi%$ 9 ! ,f$]al ,regi/] & available = public comm5t2 7,b7 e/abli% policies = ! selection &1 z applicable1 appo9tm5t (-- 7i7 ! (fic]s1 employees1 ag5ts1 & contractors ( ! ,c\ncil2 & 7ii7 ! memb]s ( any committees ( ! ,c\ncil2 7,c7 e/abli% policies1 includ+ e?ical /&>ds1 = ! conduct ( programs & o!r activities "u section #bha;,d2 & 7,d7 e/abli% specific duties ( ! ,executive ,director4 7#d7 ,meet+s 7,a7 ,9 g5]al ,! ,bo>d ( ,directors %all-- 7i7 meet on a qu>t]ly basis2 & 7ii7 submit to ,congress1 & make publicly available1 ! m9utes ( su* meet+s4 7,b7 ,ag5da ,! ,bo>d ( ,directors %all1 n lat] ?an #c mon?s aft] ! incorporation ( ! ,c\ncil-- 7i7 issue an ag5da 79 ?is "p ref]r$ to z ! ag5da7 outl9+ h[ ! ,c\ncil w a*ieve ! purpose describ$ 9 section #bha;,a2 & 7ii7 annually !reaft]1 9 consultation ) ! ,executive ,director1 review & update su* ag5da4 7b7 ,appo9tm5t & incorporation ,n lat] ?an #f mon?s aft] ! date ( enactm5t ( ! #ba/ ,c5tury ,cures ,act-- 7#a7 ! ,comptroll] ,g5]al ( ! ,unit$ ,/ates %all appo9t ! appo9t$ memb]s ( ! ,bo>d ( ,directors "u subsection 7a77#a77;,c72 & 7#b7 ! ex (ficio memb]s ( ! ,bo>d ( ,directors "u subsection 7a77#a77;,b7 %all s]ve z incorporators & %all take :atev] actions are necess>y to incorporate ! ,c\ncil4 7c7 ,nonpr(it ,/atus ,9 c>ry+ out ?is "p1 ! ,bo>d ( ,directors %all e/abli% su* policies & bylaws1 & ! ,executive ,director %all c>ry out su* activities1 z may be necess>y to ensure t ! ,c\ncil ma9ta9s /atus z an organization t-- 7#a7 is describ$ 9 subsection 7c77#c7 ( section #eja ( ! ,int]nal ,rev5ue ,code ( #aihf2 & 7#b7 is1 "u subsection 7a7 ( su* section1 exempt f taxation4 7d7 ,executive ,director ,! ,executive ,director %all-- 7#a7 be ! *ief executive (fic] ( ! ,c\ncil2 & 7#b7 subject to ! ov]sight ( ! ,bo>d ( ,directors1 be responsible = ! day-to-day managem5t ( ! ,c\ncil4 #bha;,d4 ,op]ational activities & assi/ance 7a7 ,9 g5]al ,! ,c\ncil %all e/abli% a suffici5t op]ational infra/ructure to fulfill ! duties specifi$ 9 section #bha;,b4 7b7 ,private sector mat*+ funds ,! ,c\ncil may accept f9ancial or 9-k9d support f p>ticipat+ entities or private f\ndations or organizations :5 su* support is deem$ appropriate4 #bha;,e4 ,t]m9ation2 report 7a7 ,9 g5]al ,! ,c\ncil %all t]m9ate on ,septemb] #cj1 #bjbc4 7b7 ,report ,n lat] ?an #a ye> aft] ! date on :i* ! ,c\ncil is e/abli%$ & ea* ye> !reaft]1 ! ,executive ,director %all submit to ! appropriate congressional committees a report on ! p]=mance ( ! ,c\ncil4 ,9 prep>+ su* report1 ! ,c\ncil %all consult ) a nongov]nm5tal consultant ) appropriate exp]tise4 #bha;,f4 ,fund+ ,= ! ea* ( fiscal ye>s #bjaf ?r\gh #bjbc1 !re is au?oriz$ to be appropriat$ #aj1jjj1jjj to ! ,c\ncil = purposes ( c>ry+ out ! duties ( ! ,c\ncil "u ?is "p4 4 ,,ii ,developm5t ,a ,pati5t-,focus$ ,drug ,developm5t #bjja4 ,developm5t & use ( pati5t exp]i5ce data to enhance /ructur$ risk-b5efit assessm5t framework 7a7 ,9 g5]al ,section #eje ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cee7 is am5d$-- 7#a7 9 subsection 7d71 by /rik+ ,! ,secret>y %all implem5t & all t foll[s ?r\gh prem>ket approval ( a drug42 & 7#b7 by add+ at ! end ! foll[+ new subsections3 7x7 ,/ructur$ risk-,b5efit assessm5t framework 7#a7 ,9 g5]al ,! ,secret>y %all implem5t a /ructur$ risk-b5efit assessm5t framework 9 ! new drug approval process-- 7,a7 to facilitate ! balanc$ consid]ation ( b5efits & risks2 & 7,b7 to develop & implem5t a consi/5t & sy/ematic approa* to ! discussion (1 regulatory decisionmak+ ) respect to1 & ! communication (1 ! b5efits & risks ( new drugs4 7#b7 ,rule ( con/ruction ,no?+ 9 p>agraph 7#a7 %all alt] ! crit]ia = evaluat+ an application = prem>ket approval ( a drug4 7y7 ,developm5t & use ( pati5t exp]i5ce data ,to enhance /ructur$ risk-,b5efit assessm5t framework 7#a7 ,9 g5]al ,n lat] ?an #b ye>s aft] ! date ( ! enactm5t ( ?is subsection1 ! ,secret>y %all e/abli% & implem5t processes "u :i*-- 7,a7 an entity seek+ to develop pati5t exp]i5ce data may submit to ! ,secret>y-- 7i7 initial rese>* concepts = fe$back f ! ,secret>y2 & 7ii7 ) respect to pati5t exp]i5ce data collect$ by ! entity1 draft guidance docum5ts1 complet$ data1 & summ>ies & analyses ( su* data2 7,b7 ! ,secret>y may reque/ su* an entity to submit su* docum5ts1 data1 & summ>ies & analyses2 & 7,c7 pati5t exp]i5ce data may be develop$ & us$ to enhance ! /ructur$ risk-b5efit assessm5t framework "u subsection 7x74 7#b7 ,pati5t exp]i5ce data ,9 ?is subsection1 ! t]m pati5t exp]i5ce data means data collect$ by pati5ts1 p>5ts1 c>egiv]s1 pati5t advocacy organizations1 disease rese>* f\ndations1 m$ical rese>*]s1 rese>* sponsors1 or o!r p>ties det]m9$ appropriate by ! ,secret>y t is int5d$ to facilitate or enhance ! ,secret>y's risk-b5efit assessm5ts1 includ+ in=mation ab\t ! impact ( a disease or a !rapy on pati5ts' lives4 4 7b7 ,guidance 7#a7 ,9 g5]al ,! ,secret>y ( ,heal? & ,human ,s]vices %all publi% guidance on ! implem5tation ( subsection 7y7 ( section #eje ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cee71 z add$ by subsection 7a74 ,su* guidance %all include-- 7,a7 ) respect to draft guidance docum5ts1 data1 or summ>ies & analyses submitt$ to ! ,secret>y "u p>agraph 7#a77;,a7 ( su* subsection1 guidance-- 7i7 specify+ ! timel9es = ! review ( su* docum5ts1 data1 or summ>ies & analyses by ! ,secret>y2 & 7ii7 on h[ ! ,secret>y w use su* docum5ts1 data1 or summ>ies & analyses to update any guidance docum5ts publi%$ "u ?is subsection or publi% new guidance2 7,b7 ) respect to ! collection & analysis ( pati5t exp]i5ce data 7z def9$ 9 p>agraph 7#b7 ( su* subsection 7y771 guidance on-- 7i7 me?odological consid]ations = ! collection ( pati5t exp]i5ce data1 :i* may include /ructur$ approa*es to ga!r+ in=mation on-- 7,i7 ! exp]i5ce ( a pati5t liv+ ) a p>ticul> disease2 7,,ii7 ! burd5 ( liv+ ) or manag+ ! disease2 7,,iii7 ! impact ( ! disease on daily life & long-t]m function+2 & 7,,iv7 ! effect ( curr5t !rapeutic options on diff]5t aspects ( ! disease2 & 7ii7 ! e/abli%m5t & ma9t5ance ( regi/ries design$ to increase und]/&+ ( ! natural hi/ory ( a disease2 7,c7 me?odological approa*es t may be us$ to assess pati5ts' beliefs ) respect to ! b5efits & risks 9 ! managem5t ( ! pati5t's disease2 & 7,d7 me?odologies1 /&>ds1 & pot5tial exp]im5tal designs = pati5t-report$ outcomes4 7#b7 ,tim+ ,n lat] ?an #c ye>s aft] ! date ( ! enactm5t ( ?is ,act1 ! ,secret>y ( ,heal? & ,human ,s]vices %all issue draft guidance on ! implem5tation ( subsection 7y7 ( section #eje ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cee71 z add$ by subsection 7a74 ,! ,secret>y %all issue f9al guidance on ! implem5tation ( su* subsection n lat] ?an #a ye> aft] ! date on :i* ! comm5t p]iod = ! draft guidance closes4 7#c7 ,work%ops 7,a7 ,9 g5]al ,n lat] ?an #f mon?s aft] ! date ( ! enactm5t ( ?is ,act & once e #f mon?s dur+ ! foll[+ #ab-mon? p]iod1 ! ,secret>y ( ,heal? & ,human ,s]vices %all conv5e a work%op to obta9 input reg>d+ me?odologies = develop+ ! guidance "u p>agraph 7#a71 includ+ ! collection ( pati5t exp]i5ce data4 7,b7 ,att5dees ,a work%op conv5$ "u ?is p>agraph %all include-- 7i7 pati5ts2 7ii7 repres5tatives f pati5t advocacy organizations1 bioph>maceutical companies1 & disease rese>* f\ndations2 7iii7 repres5tatives ( ! review+ divisions ( ! ,food & ,drug ,adm9i/ration2 & 7iv7 me?odological exp]ts ) significant exp]tise 9 pati5t exp]i5ce data4 7#d7 ,public meet+ ,n lat] ?an #ij days aft] ! date on :i* ! draft guidance is publi%$ "u ?is subsection1 ! ,secret>y ( ,heal? & ,human ,s]vices %all conv5e a public meet+ to solicit input on ! guidance4 ,b ,qualification & ,use ( ,drug ,developm5t ,tools #bjba4 ,qualification ( drug developm5t tools 7a7 ,f9d+s ,congress f9ds ! foll[+3 7#a7 ,developm5t ( new drugs has become increas+ly *all5g+ & res\rce int5sive4 7#b7 ,developm5t ( drug developm5t tools c b5efit ! availability ( new m$ical !rapies by help+ to translate sci5tific discov]ies into cl9ical applications4 7#c7 ,biom$ical rese>* consortia 7z def9$ 9 section #ejg7;f7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act1 z add$ by subsection 7c77 c play a valuable role 9 help+ to develop & qualify drug developm5t tools4 7b7 ,s5se ( ,congress ,x is ! s5se ( ,congress t-- 7#a7 ,congress %\ld promote & facilitate a collaborative ef=t among ! biom$ical rese>* consortia describ$ 9 subsection 7a77#c7-- 7,a7 to develop1 ?r\gh a transp>5t public process1 data /&>ds & sci5tific approa*es to data collection accept$ by ! m$ical & cl9ical rese>* community = purposes ( qualify+ drug developm5t tools2 7,b7 to coord9ate ef=ts t[>d develop+ & qualify+ drug developm5t tools 9 key !rapeutic areas2 & 7,c7 to enc\rage ! developm5t ( accessible databases = collect+ relevant drug developm5t tool data = su* purposes2 & 7#b7 an entity seek+ to qualify a drug developm5t tool %\ld be enc\rag$1 9 addition to consultation ) ! ,secret>y1 to consult ) biom$ical rese>* consortia & o!r individuals & entities ) exp]t k & insights t may assi/ ! reque/or & b5efit ! process = su* qualification4 7c7 ,qualification ( drug developm5t tools ,*apt] ,v ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act is am5d$ by ins]t+ aft] section #ejf;,f ! foll[+ new section3 #ejg4 ,qualification ( drug developm5t tools 7a7 ,process = qualification 7#a7 ,9 g5]al ,! ,secret>y %all e/abli% a process = ! qualification ( drug developm5t tools = a propos$ context ( use "u :i*-- 7,a7 7i7 a reque/or initiates su* process by submitt+ a lett] ( int5t to ! ,secret>y2 & 7ii7 ! ,secret>y accepts or decl9es to accept su* lett] ( int5t2 7,b7 7i7 if ! ,secret>y accepts ! lett] ( int5t1 a reque/or submits a qualification plan to ! ,secret>y2 & 7ii7 ! ,secret>y accepts or decl9es to accept ! qualification plan2 & 7,c7 7i7 if ! ,secret>y accepts ! qualification plan1 ! reque/or submits to ! ,secret>y a full qualification package2 7ii7 ! ,secret>y det]m9es :e!r to accept su* qualification package = review2 & 7iii7 if ! ,secret>y accepts su* qualification package = review1 ! ,secret>y conducts su* review 9 accordance ) ?is section4 7#b7 ,acceptance & review ( submissions 7,a7 ,9 g5]al ,! succe$+ provisions ( ?is p>agraph %all apply ) respect to ! treatm5t ( a lett] ( int5t1 a qualification plan1 or a full qualification package submitt$ "u p>agraph 7#a7 7ref]r$ to 9 ?is p>agraph z qualification submissions74 7,b7 ,acceptance factors2 nonacceptance ,! ,secret>y %all det]m9e :e!r to accept a qualification submission bas$ on factors :i* may include ! sci5tific m]it ( ! submission & ! available res\rces ( ! ,food & ,drug ,adm9i/ration to review ! qualification submission4 ,a det]m9ation n to accept a submission "u p>agraph 7#a7 %all n be con/ru$ z a f9al det]m9ation by ! ,secret>y "u ?is section reg>d+ ! qualification ( a drug developm5t tool = its propos$ context ( use4 7,c7 ,prioritization ( qualification review ,! ,secret>y may prioritize ! review ( a full qualification package submitt$ "u p>agraph 7#a7 ) respect to a drug developm5t tool1 bas$ on factors det]m9$ appropriate by ! ,secret>y1 includ+-- 7i7 z applicable1 ! sev]ity1 r>ity1 or preval5ce ( ! disease or condition t>get$ by ! drug developm5t tool & ! availability or lack ( alt]native treatm5ts = su* disease or condition2 & 7ii7 ! id5tification1 by ! ,secret>y or by biom$ical rese>* consortia & o!r exp]t /akehold]s1 ( su* a drug developm5t tool & its propos$ context ( use z a public heal? priority4 7,d7 ,engagem5t ( ext]nal exp]ts ,! ,secret>y may1 = purposes ( ! review ( qualification submissions1 ?r\gh ! use ( coop]ative agreem5ts1 grants1 or o!r appropriate me*anisms1 consult ) biom$ical rese>* consortia & may consid] ! recomm5dations ( su* consortia ) respect to ! review ( any qualification plan submitt$ "u p>agraph 7#a7 or ! review ( any full qualification package "u p>agraph 7#c74 7#c7 ,review ( full qualification package ,! ,secret>y %all-- 7,a7 conduct a compreh5sive review ( a full qualification package accept$ "u p>agraph 7#a77;,c72 & 7,b7 det]m9e :e!r ! drug developm5t tool at issue is qualifi$ = its propos$ context ( use4 7#d7 ,qualification ,! ,secret>y %all det]m9e :e!r a drug developm5t tool is qualifi$ = a propos$ context ( use bas$ on ! sci5tific m]it ( a full qualification package review$ "u p>agraph 7#c74 7b7 ,effect ( qualification 7#a7 ,9 g5]al ,a drug developm5t tool det]m9$ to be qualifi$ "u subsection 7a77#d7 = a propos$ context ( use specifi$ by ! reque/or may be us$ by any p]son 9 su* context ( use = ! purposes describ$ 9 p>agraph 7#b74 7#b7 ,use ( a drug developm5t tool ,subject to p>agraph 7#c71 a drug developm5t tool qualifi$ "u ?is section may be us$ =-- 7,a7 support+ or obta9+ approval or lic5sure 7z applicable7 ( a drug or biological product 7includ+ 9 accordance ) section #ejf7;c77 "u section #eje ( ?is ,act or section #cea ( ! ,public ,heal? ,s]vice ,act2 or 7,b7 support+ ! inve/igational use ( a drug or biological product "u section #eje7;i7 ( ?is ,act or section #cea7;a77#c7 ( ! ,public ,heal? ,s]vice ,act4 7#c7 ,rescission or modification 7,a7 ,9 g5]al ,! ,secret>y may resc9d or modify a det]m9ation "u ?is section to qualify a drug developm5t tool if ! ,secret>y det]m9es t ! drug developm5t tool is n appropriate = ! propos$ context ( use specifi$ by ! reque/or4 ,su* a det]m9ation may be bas$ on new in=mation t calls into "q ! basis = su* qualification4 7,b7 ,meet+ = review ,if ! ,secret>y resc9ds or modifies "u subp>agraph 7,a7 a det]m9ation to qualify a drug developm5t tool1 ! reque/or involv$ %all1 on reque/1 be grant$ a meet+ ) ! ,secret>y to discuss ! basis ( ! ,secret>y's decision to resc9d or modify ! det]m9ation be=e ! effective date ( ! rescission or modification4 7c7 ,transp>5cy 7#a7 ,9 g5]al ,subject to p>agraph 7#c71 ! ,secret>y %all make publicly available1 & update on at lea/ a biannual basis1 on ! ,int]net website ( ! ,food & ,drug ,adm9i/ration ! foll[+3 7,a7 ,in=mation ) respect to ea* qualification submission "u ! qualification process "u subsection 7a71 includ+-- 7i7 ! /age ( ! review process applicable to ! submission2 7ii7 ! date ( ! mo/ rec5t *ange 9 /age /atus2 7iii7 :e!r ! ext]nal sci5tific exp]ts 7 utiliz$ 9 ! developm5t ( a qualification plan or ! review ( a full qualification package2 & 7iv7 submissions f reque/ors "u ! qualification process "u subsection 7a71 includ+ any data & evid5ce conta9$ 9 su* submissions1 & any updates to su* submissions4 7,b7 ,! ,secret>y's =mal writt5 det]m9ations 9 response to su* qualification submissions4 7,c7 ,any rescissions or modifications "u subsection 7b77#c7 ( a det]m9ation to qualify a drug developm5t tool4 7,d7 ,summ>y reviews t docum5t conclusions & recomm5dations = det]m9ations to qualify drug developm5t tools "u subsection 7a74 7,e7 ,a compreh5sive li/ (-- 7i7 all drug developm5t tools qualifi$ "u subsection 7a72 & 7ii7 all surrogate endpo9ts :i* 7 ! basis ( approval or lic5sure 7z applicable7 ( a drug or biological product 7includ+ 9 accordance ) section #ejf7;c77 "u section #eje ( ?is ,act or section #cea ( ! ,public ,heal? ,s]vice ,act4 7#b7 ,relation to ,trade ,secrets ,act ,in=mation made publicly available by ! ,secret>y "u p>agraph 7#a7 %all be consid]$ a disclosure au?oriz$ by law = purposes ( section #aije ( title #ah1 ,unit$ ,/ates ,code4 7#c7 ,applicability ,no?+ 9 ?is section %all be con/ru$ z au?oriz+ ! ,secret>y to disclose any in=mation conta9$ 9 an application submitt$ "u section #eje ( ?is ,act or section #cea ( ! ,public ,heal? ,s]vice ,act t is confid5tial comm]cial or trade secret in=mation subject to section #eeb7;b77#d7 ( title #e1 ,unit$ ,/ates ,code1 or section #aije ( title #ah1 ,unit$ ,/ates ,code4 7d7 ,rule ( con/ruction ,no?+ 9 ?is section %all be con/ru$-- 7#a7 to alt] ! /&>ds ( evid5ce "u subsection 7c7 or 7d7 ( section #eje1 includ+ ! sub/antial evid5ce /&>d 9 su* subsection 7d71 or "u section #cea ( ! ,public ,heal? ,s]vice ,act 7z applicable72 or 7#b7 to limit ! au?ority ( ! ,secret>y to approve or lic5se products "u ?is ,act or ! ,public ,heal? ,s]vice ,act1 z applicable 7z 9 effect be=e ! date ( ! enactm5t ( ! #ba/ ,c5tury ,cures ,act74 7e7 ,def9itions ,9 ?is section3 7#a7 ,biom>k] 7,a7 ,! t]m biom>k] means a *>act]i/ic 7su* z a physiologic1 pa?ologic1 or anatomic *>act]i/ic or measurem5t7 t is objectively measur$ & evaluat$ z an indicator ( normal biologic processes1 pa?ologic processes1 or biological responses to a !rapeutic int]v5tion2 & 7,b7 su* t]m includes a surrogate endpo9t4 7#b7 ,biom$ical rese>* consortia ,! t]m biom$ical rese>* consortia means collaborative gr\ps t may take ! =m ( public-private p>tn]%ips & may include gov]nm5t ag5cies1 in/itutions ( high] education 7z def9$ 9 section #aja7;a7 ( ! ,high] ,education ,act ( #aife71 pati5t advocacy gr\ps1 indu/ry repres5tatives1 cl9ical & sci5tific exp]ts1 & o!r relevant entities & individuals4 7#c7 ,cl9ical outcome assessm5t 7,a7 ,! t]m cl9ical outcome assessm5t means a measurem5t ( a pati5t's symptoms1 ov]all m5tal /ate1 or ! effects ( a disease or condition on h[ ! pati5t functions2 & 7,b7 su* t]m includes a pati5t-report$ outcome4 7#d7 ,context ( use ,! t]m context ( use means1 ) respect to a drug developm5t tool1 ! circum/ances "u :i* ! drug developm5t tool is to be us$ 9 drug developm5t & regulatory review4 7#e7 ,drug developm5t tool ,! t]m drug developm5t tool includes-- 7,a7 a biom>k]2 7,b7 a cl9ical outcome assessm5t2 & 7,c7 any o!r me?od1 mat]ial1 or measure t ! ,secret>y det]m9es aids drug developm5t & regulatory review = purposes ( ?is section4 7#f7 ,pati5t-report$ outcome ,! t]m pati5t-report$ outcome means a measurem5t bas$ on a report f a pati5t reg>d+ ! /atus ( ! pati5t's heal? condition )\t am5dm5t or int]pretation ( ! pati5t's report by a cl9ician or any o!r p]son4 7#g7 ,qualification ,! t]ms qualification & qualifi$ mean a det]m9ation by ! ,secret>y t a drug developm5t tool & its propos$ context ( use c be reli$ ^u to h a specific int]pretation & application 9 drug developm5t & regulatory review "u ?is ,act4 7#h7 ,reque/or ,! t]m reque/or means an entity or entities1 includ+ a drug sponsor or a biom$ical rese>* consortia1 seek+ to qualify a drug developm5t tool = a propos$ context ( use "u ?is section4 7#i7 ,surrogate endpo9t ,! t]m surrogate endpo9t means a m>k]1 su* z a laboratory measurem5t1 radiographic image1 physical sign1 or o!r measure1 t is n itself a direct measurem5t ( cl9ical b5efit1 &-- 7,a7 is kn[n to pr$ict cl9ical b5efit & c\ld be us$ to support traditional approval ( a drug or biological product2 or 7,b7 is reasonably likely to pr$ict cl9ical b5efit & c\ld be us$ to support ! accel]at$ approval ( a drug or biological product 9 accordance ) section #ejf7;c74 7f7 ,au?orization ( appropriations ,!re are au?oriz$ to be appropriat$ to c>ry out ?is section1 #aj1jjj1jjj = ea* ( fiscal ye>s #bjaf ?r\gh #bjbj4 4 7d7 ,guidance 7#a7 ,9 g5]al ,! ,secret>y ( ,heal? & ,human ,s]vices %all1 9 consultation ) biom$ical rese>* consortia 7z def9$ 9 subsection 7f7 ( section #ejg ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7z add$ by subsection 7c777 & o!r int]e/$ p>ties ?r\gh a collaborative public process1 issue guidance to implem5t su* section #ejg t-- 7,a7 provides a conceptual framework describ+ appropriate /&>ds & sci5tific approa*es to support ! developm5t ( biom>k]s del9eat$ "u ! taxonomy e/abli%$ "u p>agraph 7#c72 7,b7 makes recomm5dations = demon/rat+ t a surrogate endpo9t is reasonably likely to pr$ict cl9ical b5efit = ! purpose ( support+ ! accel]at$ approval ( a drug "u section #ejf7;c7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cef7;c772 7,c7 ) respect to ! qualification process "u su* section #ejg-- 7i7 describes ! requirem5ts t entities seek+ to qualify a drug developm5t tool "u su* section %all obs]ve :5 engag+ 9 su* process2 7ii7 outl9es reasonable timeframes = ! ,secret>y's review ( lett]s1 qualification plans1 or full qualification packages submitt$ "u su* process2 & 7iii7 e/abli%es a process by :i* su* entities or ! ,secret>y may consult ) biom$ical rese>* consortia & o!r individuals & entities ) exp]t k & insights t may assi/ ! ,secret>y 9 ! review ( qualification plans & full qualification submissions "u su* section2 & 7,d7 includes su* o!r in=mation z ! ,secret>y det]m9es appropriate4 7#b7 ,tim+ ,n lat] ?an #bd mon?s aft] ! date ( ! enactm5t ( ?is ,act1 ! ,secret>y ( ,heal? & ,human ,s]vices %all issue draft guidance "u p>agraph 7#a7 on ! implem5tation ( section #ejg ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7z add$ by subsection 7c774 ,! ,secret>y %all issue f9al guidance on ! implem5tation ( su* section n lat] ?an #f mon?s aft] ! date on :i* ! comm5t p]iod = ! draft guidance closes4 7#c7 ,taxonomy 7,a7 ,9 g5]al ,= purposes ( in=m+ guidance "u ?is subsection1 ! ,secret>y ( ,heal? & ,human ,s]vices %all1 9 consultation ) biom$ical rese>* consortia & o!r int]e/$ p>ties ?r\gh a collaborative public process1 e/abli% a taxonomy = ! classification ( biom>k]s 7& relat$ sci5tific concepts7 = use 9 drug developm5t4 7,b7 ,public availability ,n lat] ?an #ab mon?s aft] ! date ( ! enactm5t ( ?is ,act1 ! ,secret>y ( ,heal? & ,human ,s]vices %all make su* taxonomy publicly available 9 draft =m = public comm5t4 ,! ,secret>y %all f9alize ! taxonomy n lat] ?an #ab mon?s aft] ! close ( ! public comm5t p]iod4 7e7 ,meet+ & report 7#a7 ,meet+ ,n lat] ?an #ab mon?s aft] ! date ( ! enactm5t ( ?is ,act1 ! ,secret>y ( ,heal? & ,human ,s]vices %all conv5e a public meet+ to describe & solicit public input reg>d+ ! qualification process "u section #ejg ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act1 z add$ by subsection 7c74 7#b7 ,report ,n lat] ?an #e ye>s aft] ! date ( ! enactm5t ( ?is ,act1 ! ,secret>y %all make publicly available on ! ,int]net website ( ! ,food & ,drug ,adm9i/ration a report4 ,su* report %all include1 ) respect to ! qualification process "u section #ejg ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act1 z add$ by subsection 7c71 in=mation on-- 7,a7 ! numb] ( reque/s submitt$1 z a lett] ( int5t1 = qualification ( a drug developm5t tool 7z def9$ 9 subsection 7f7 ( su* section72 7,b7 ! numb] ( su* reque/s accept$ & det]m9$ to be eligible = submission ( a qualification plan or full qualification package 7z su* t]ms are def9$ 9 su* subsection71 respectively2 7,c7 ! numb] ( su* reque/s = :i* ext]nal sci5tific exp]ts 7 utiliz$ 9 ! developm5t ( a qualification plan or review ( a full qualification package2 7,d7 ! numb] ( qualification plans & full qualification packages1 respectively1 submitt$ to ! ,secret>y2 & 7,e7 ! drug developm5t tools qualifi$ ?r\gh su* qualification process1 specifi$ by type ( tool1 su* z a biom>k] or cl9ical outcome assessm5t 7z su* t]ms are def9$ 9 subsection 7f7 ( su* section #ejg74 #bjbb4 ,accel]at$ approval developm5t plan 7a7 ,9 g5]al ,section #ejf ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cef7 is am5d$ by add+ ! foll[+ subsection3 7g7 ,accel]at$ approval developm5t plan 7#a7 ,9 g5]al ,9 ! case ( a drug t ! ,secret>y det]m9es may be eligible = accel]at$ approval 9 accordance ) subsection 7c71 ! sponsor ( su* drug may reque/1 at any "t aft] ! submission ( an application = ! inve/igation ( ! drug "u section #eje7;i7 ( ?is ,act or section #cea7;a77#c7 ( ! ,public ,heal? ,s]vice ,act1 t ! ,secret>y agree to an accel]at$ approval developm5t plan describ$ 9 p>agraph 7#b74 7#b7 ,plan describ$ ,a plan describ$ 9 ?is p>agraph1 ) respect to a drug describ$ 9 p>agraph 7#a71 is an accel]at$ approval developm5t plan1 :i* %all include agreem5t on-- 7,a7 ! surrogate endpo9t to be assess$ "u su* plan2 7,b7 ! design ( ! /udy t w utilize ! surrogate endpo9t2 & 7,c7 ! magnitude ( ! effect ( ! drug on ! surrogate endpo9t t is ! subject ( ! agreem5t t w\ld be suffici5t to =m ! prim>y basis ( a claim t ! drug is effective4 7#c7 ,modification2 t]m9ation ,! ,secret>y may require ! sponsor ( a drug t is ! subject ( an accel]at$ approval developm5t plan to modify or t]m9ate ! plan if additional data or in=mation indicates t-- 7,a7 ! plan z orig9ally agre$ ^u is no long] suffici5t to demon/rate ! safety & effectiv5ess ( ! drug involv$2 or 7,b7 ! drug is no long] eligible = accel]at$ approval "u subsection 7c74 7#d7 ,sponsor consultation ,if ! ,secret>y requires ! modification or t]m9ation ( an accel]at$ approval developm5t plan "u p>agraph 7#c71 ! sponsor %all be grant$ a reque/ = a meet+ to discuss ! basis ( ! ,secret>y's decision be=e ! effective date ( ! modification or t]m9ation4 7#e7 ,def9ition ,9 ?is section1 ! t]m accel]at$ approval developm5t plan means a developm5t plan agre$ ^u by ! ,secret>y & ! sponsor submitt+ ! plan t conta9s /udy p>amet]s = ! use ( a surrogate endpo9t t-- 7,a7 is reasonably likely to pr$ict cl9ical b5efit2 & 7,b7 is int5d$ to be ! basis ( ! accel]at$ approval ( a drug 9 accordance ) subsection 7c74 4 7b7 ,te*nical am5dm5ts ,section #ejf ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cef7 is am5d$-- 7#a7 by /rik+ 7f7 ,aw>5ess ef=ts & ins]t+ 7e7 ,aw>5ess ef=ts2 & 7#b7 by /rik+ 7e7 ,con/ruction & ins]t+ 7f7 ,con/ruction4 ,c ,,fda advancem5t ( ,precision ,m$ic9e #bjda4 ,precision m$ic9e guidance & o!r programs ( ,food & ,drug ,adm9i/ration ,*apt] ,v ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cea et seq47 is am5d$ by add+ at ! end ! foll[+3 ,j ,precision ,m$ic9e #eia4 ,g5]al ag5cy guidance on precision m$ic9e 7a7 ,9 g5]al ,! ,secret>y %all issue & p]iodically update guidance to assi/ sponsors 9 ! developm5t ( a precision drug or biological product4 ,su* guidance %all-- 7#a7 def9e ! t]m precision drug or biological product2 & 7#b7 address ! topics describ$ 9 subsection 7b74 7b7 ,c]ta9 issues ,! topics to be address$ by guidance "u subsection 7a7 are-- 7#a7 ! evid5ce ne$$ to support ! use ( biom>k]s 7z def9$ 9 section #ejg7;e77 t id5tify subsets ( pati5ts z likely respond]s to !rapies 9 ord] to /reaml9e ! conduct ( cl9ical trials2 7#b7 recomm5dations = ! design ( /udies to demon/rate ! validity ( a biom>k] z a pr$ictor ( drug or biological product response2 7#c7 ! mann] & ext5t to :i* a b5efit-risk assessm5t may be affect$ :5 cl9ical trials are limit$ to pati5t population subsets t are id5tifi$ us+ biom>k]s2 7#d7 ! developm5t ( companion diagno/ics 9 ! context ( a drug developm5t program2 & 7#e7 consid]ations = develop+ biom>k]s t in=m prescrib+ decisions = a drug or biological product1 & :5 in=mation reg>d+ a biom>k] may be includ$ 9 ! approv$ prescription label+ = a precision drug or biological product4 7c7 ,date c]ta9 = initial guidance ,! ,secret>y %all issue guidance "u subsection 7a7 n lat] ?an #ah mon?s aft] ! date ( ! enactm5t ( ! #ba/ ,c5tury ,cures ,act4 #eib4 ,precision m$ic9e reg>d+ orphan-drug & exp$it$-approval programs 7a7 ,9 g5]al ,9 ! case ( a precision drug or biological product t is ! subject ( an application submitt$ "u section #eje7;b77#a71 or section #cea7;a7 ( ! ,public ,heal? ,s]vice ,act1 = ! treatm5t ( a s]i\s or life-?reat5+ disease or condition & has be5 designat$ "u section #ebf z a drug = a r>e disease or condition1 ! ,secret>y may-- 7#a7 consi/5t ) applicable /&>ds = approval1 rely ^u data or in=mation previ\sly submitt$ by ! sponsor ( ! precision drug or biological product1 or ano!r sponsor1 provid$ t ! sponsor ( ! precision drug or biological product has obta9$ a contractual "r ( ref]5ce to su* o!r sponsor's data & in=mation1 9 an application approv$ "u section #eje7;c7 or lic5s$ "u section #cea7;a7 ( ! ,public ,heal? ,s]vice ,act1 z applicable-- 7,a7 = a diff]5t drug or biological product2 or 7,b7 = a diff]5t indication = su* precision drug or biological product1 9 ord] to exp$ite cl9ical developm5t = a precision drug or biological product t is us+ ! same or simil> approa* z t us$ to support approval ( ! prior approv$ application or lic5se1 z appropriate2 & 7#b7 z appropriate1 consid] ! application = approval ( su* precision drug or biological product to be eligible = exp$it$ review & approval programs describ$ 9 section #ejf1 includ+ accel]at$ approval 9 accordance ) subsection 7c7 ( su* section4 7b7 ,rule ( con/ruction ,no?+ 9 ?is section %all be con/ru$ to-- 7#a7 limit ! au?ority ( ! ,secret>y to approve products pursuant to ?is ,act & ! ,public ,heal? ,s]vice ,act z au?oriz$ prior to ! date ( enactm5t ( ?is section2 or 7#b7 conf] any new rights1 beyond ^? au?oriz$ "u ?is ,act prior to enactm5t ( ?is section1 ) respect to a sponsor's ability to ref]5ce in=mation conta9$ 9 ano!r application submitt$ "u section #eje7;b77#a7 ( ?is ,act or section #cea7;a7 ( ! ,public ,heal? ,s]vice ,act4 4 ,d ,mod]n ,trial ,design & ,evid5ce ,developm5t #bjfa4 ,broad] application ( ,bayesian /ati/ics & adaptive trial designs 7a7 ,proposals = use ( innovative /ati/ical me?ods 9 cl9ical protocols = drugs & biological products ,= purposes ( assi/+ sponsors 9 incorporat+ adaptive trial design & ,bayesian me?ods into propos$ cl9ical protocols & applications = new drugs "u section #eje ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cee7 & biological products "u section #cea ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bfb71 ! ,secret>y %all conduct a public meet+ & issue guidance 9 accordance ) subsection 7b74 7b7 ,guidance address+ use ( adaptive trial designs & ,bayesian me?ods 7#a7 ,9 g5]al ,! ,secret>y ( ,heal? & ,human ,s]vices1 act+ ?r\gh ! ,commission] ( ,food & ,drugs 79 ?is subsection ref]r$ to z ! ,secret>y71 %all-- 7,a7 update & f9alize ! draft guidance address+ ! use ( adaptive trial design = drugs & biological products2 & 7,b7 issue draft guidance on ! use ( ,bayesian me?ods 9 ! developm5t & regulatory review & approval or lic5sure ( drugs & biological products4 7#b7 ,cont5ts ,! guidances "u p>agraph 7#a7 %all address-- 7,a7 ! use ( adaptive trial designs & ,bayesian me?ods 9 cl9ical trials1 includ+ cl9ical trials propos$ or submitt$ to help to satisfy ! sub/antial evid5ce /&>d "u section #eje7;d7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cee7;d772 7,b7 h[ sponsors may obta9 fe$back f ! ,secret>y on te*nical issues relat$ to model+ & simulations prior to-- 7i7 completion ( su* model+ or simulations2 or 7ii7 ! submission ( result+ in=mation to ! ,secret>y2 7,c7 ! types ( quantitative & qualitative in=mation t %\ld be submitt$ = review2 & 7,d7 recomm5d$ analysis me?odologies4 7#c7 ,public meet+ ,prior to updat+ or develop+ ! guidances requir$ by p>agraph 7#a71 ! ,secret>y %all consult ) /akehold]s1 includ+ repres5tatives ( regulat$ indu/ry1 academia1 pati5t advocacy organizations1 & disease rese>* f\ndations1 ?r\gh a public meet+ to be held n lat] ?an #a ye> aft] ! date ( enactm5t ( ?is ,act4 7#d7 ,s*$ule ,! ,secret>y %all publi%-- 7,a7 ! f9al guidance requir$ by p>agraph 7#a77;,a7 n lat] ?an #ah mon?s aft] ! date ( ! public meet+ requir$ by p>agraph 7#c72 & 7,b7 ! guidance requir$ by p>agraph 7#a77;,b7 n lat] ?an #dh mon?s aft] ! date ( ! public meet+ requir$ by p>agraph 7#c74 #bjfb4 ,utiliz+ evid5ce f cl9ical exp]i5ce ,*apt] ,v ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act is am5d$ by ins]t+ aft] section #eje;,e ( su* ,act 7#ba ,u4,s4,c4 #cee;f7 ! foll[+3 #eje;,f4 ,utiliz+ evid5ce f cl9ical exp]i5ce 7a7 ,9 g5]al ,! ,secret>y %all e/abli% a program to evaluate ! pot5tial use ( evid5ce f cl9ical exp]i5ce-- 7#a7 to help to support ! approval ( a new indication = a drug approv$ "u section #eje7;b72 & 7#b7 to help to support or satisfy po/approval /udy requirem5ts4 7b7 ,evid5ce f cl9ical exp]i5ce def9$ ,9 ?is section1 ! t]m evid5ce f cl9ical exp]i5ce means data reg>d+ ! usage1 or ! pot5tial b5efits or risks1 ( a drug d]iv$ f s\rces o!r ?an r&omiz$ cl9ical trials1 includ+ f obs]vational /udies1 regi/ries1 & !rapeutic use4 7c7 ,program framework 7#a7 ,9 g5]al ,n lat] ?an #ah mon?s aft] ! date ( enactm5t ( ?is section1 ! ,secret>y %all e/abli% a draft framework = implem5tation ( ! program "u ?is section4 7#b7 ,cont5ts ( framework ,! framework %all include in=mation describ+-- 7,a7 ! curr5t s\rces ( data develop$ ?r\gh cl9ical exp]i5ce1 includ+ ongo+ safety surveillance1 regi/ry1 claims1 & pati5t-c5t]$ outcomes rese>* activities2 7,b7 ! gaps 9 curr5t data collection activities2 7,c7 ! curr5t /&>ds & me?odologies = collection & analysis ( data g5]at$ ?r\gh cl9ical exp]i5ce2 & 7,d7 ! priority areas1 rema9+ *all5ges1 & pot5tial pilot opportunities t ! program e/abli%$ "u ?is section w address4 7#c7 ,consultation 7,a7 ,9 g5]al ,9 develop+ ! program framework "u ?is subsection1 ! ,secret>y %all consult ) regulat$ indu/ry1 academia1 m$ical pr(essional organizations1 repres5tatives ( pati5t advocacy organizations1 disease rese>* f\ndations1 & o!r int]e/$ p>ties4 7,b7 ,process ,! consultation "u subp>agraph 7,a7 may be c>ri$ out ?r\gh approa*es su* z-- 7i7 a public-private p>tn]%ip ) ! entities describ$ 9 su* subp>agraph 9 :i* ! ,secret>y may p>ticipate2 or 7ii7 a contract1 grant1 or o!r arrangem5t1 z det]m9$ appropriate by ! ,secret>y ) su* a p>tn]%ip or an indep5d5t rese>* organization4 7d7 ,program implem5tation ,! ,secret>y %all1 n lat] ?an #bd mon?s aft] ! date ( enactm5t ( ?is section & 9 accordance ) ! framework e/abli%$ "u subsection 7c71 implem5t ! program to evaluate ! pot5tial use ( evid5ce f cl9ical exp]i5ce4 7e7 ,guidance = indu/ry ,! ,secret>y %all-- 7#a7 utilize ! program e/abli%$ "u subsection 7a71 its activities1 & any subsequ5t pilots or writt5 reports1 to in=m a guidance = indu/ry on-- 7,a7 ! circum/ances "u :i* sponsors ( drugs & ! ,secret>y may rely on evid5ce f cl9ical exp]i5ce = ! purposes describ$ 9 subsection 7a77#a7 or 7a77#b72 & 7,b7 ! appropriate /&>ds & me?odologies = collection & analysis ( evid5ce f cl9ical exp]i5ce submitt$ = su* purposes2 7#b7 n lat] ?an #cf mon?s aft] ! date ( enactm5t ( ?is section1 issue draft guidance = indu/ry z describ$ 9 p>agraph 7#a72 & 7#c7 n lat] ?an #dh mon?s aft] ! date ( enactm5t ( ?is section1 aft] provid+ an opportunity = public comm5t on ! draft guidance1 issue f9al guidance4 7f7 ,rule ( con/ruction 7#a7 ,subject to p>agraph 7#b71 no?+ 9 ?is section prohibits ! ,secret>y f us+ evid5ce f cl9ical exp]i5ce = purposes n specifi$ 9 ?is section1 provid$ ! ,secret>y det]m9es t suffici5t basis exi/s = any su* nonspecifi$ use4 7#b7 ,?is section %all n be con/ru$ to alt]-- 7,a7 ! /&>ds ( evid5ce "u-- 7i7 subsection 7c7 or 7d7 ( section #eje1 includ+ ! sub/antial evid5ce /&>d 9 su* subsection 7d72 or 7ii7 section #cea7;a7 ( ! ,public ,heal? ,s]vice ,act2 or 7,b7 ! ,secret>y's au?ority to require po/approval /udies or cl9ical trials1 or ! /&>ds ( evid5ce "u :i* /udies or trials are evaluat$4 #eje;,g4 ,collect+ evid5ce f cl9ical exp]i5ce ?r\gh t>get$ ext5sions ( ! ,s5t9el ,sy/em 7a7 ,9 g5]al ,! ,secret>y %all1 9 p>allel to implem5t+ ! program e/abli%$ "u section #eje;,f & 9 ord] to build capacity = utiliz+ ! evid5ce f cl9ical exp]i5ce describ$ 9 t section1 id5tify & execute pilot demon/rations to ext5d exi/+ use ( ! ,s5t9el ,sy/em surveillance infra/ructure au?oriz$ "u section #eje7k74 7b7 ,pilot demon/rations 7#a7 ,9 g5]al ,! ,secret>y-- 7,a7 %all design & implem5t pilot demon/rations to utilize data captur$ ?r\gh ! ,s5t9el ,sy/em surveillance infra/ructure au?oriz$ "u section #eje7k7 = purposes (1 z appropriate-- 7i7 g5]at+ evid5ce f cl9ical exp]i5ce to improve *>act]ization or assessm5t ( risks or b5efits ( a drug approv$ "u section #eje7;c72 7ii7 protect+ ! public heal?2 or 7iii7 advanc+ pati5t-c5t]$ c>e2 & 7,b7 may make /rategic l9kages ) s\rces ( complem5t>y public heal? data & infra/ructure ! ,secret>y det]m9es appropriate & necess>y4 7#b7 ,consultation ,9 develop+ ! pilot demon/rations "u ?is subsection1 ! ,secret>y %all-- 7,a7 consult ) regulat$ indu/ry1 academia1 m$ical pr(essional organizations1 repres5tatives ( pati5t advocacy organizations1 disease rese>* f\ndations1 & o!r int]e/$ p>ties ?r\gh a public process2 & 7,b7 develop a framework to promote appropriate transp>5cy & dialogue ab\t rese>* conduct$ "u ^! pilot demon/rations1 includ+ by-- 7i7 provid+ adequate notice to a sponsor ( a drug approv$ "u section #eje or section #cea ( ! ,public ,heal? ,s]vice ,act ( ! ,secret>y's int5t to conduct analyses ( su* sponsor's drug or drugs "u ^! pilot demon/rations2 7ii7 provid+ adequate notice ( ! f9d+s relat$ to analyses describ$ 9 clause 7i7 & an opportunity = ! sponsor ( su* drug or drugs to comm5t on su* f9d+s2 & 7iii7 ensur+ ! protection f public disclosure ( any in=mation t is a trade secret or confid5tial in=mation subject to section #eeb7;b77#d7 ( title #e1 ,unit$ ,/ates ,code1 or section #aije ( title #ah1 ,unit$ ,/ates ,code4 7#c7 ,,hipaa privacy rule2 human subject rese>* regulation ,! ,secret>y may deem su* pilot demon/rations-- 7,a7 public heal? activities1 = purposes ( :i* a use or disclosure ( protect$ heal? in=mation w\ld be p]mitt$ z describ$ 9 section #afd4eab7;b77#a7 ( title #de1 ,code ( ,f$]al ,regulations 7or any successor regulation72 & 7,b7 outside ! scope ( rese>* z def9$ 9 section #df4ajb7;d7 ( title #de1 ,code ( ,f$]al ,regulations 7or any successor regulation74 7c7 ,au?orization ( appropriations ,!re are au?oriz$ to be appropriat$ to c>ry out ?is section #c1jjj1jjj = ea* ( fiscal ye>s #bjaf ?r\gh #bjbj4 4 #bjfc4 ,/reaml9$ data review program 7a7 ,9 g5]al ,*apt] ,v ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act1 z am5d$ by section #bjfb1 is fur!r am5d$ by ins]t+ aft] section #eje;,g ( su* ,act ! foll[+3 #eje;,h4 ,/reaml9$ data review program 7a7 ,9 g5]al ,! ,secret>y %all e/abli% a /reaml9$ data review program "u :i* a hold] ( an approv$ application submitt$ "u section #eje7;b77#a7 or "u section #cea7;a7 ( ! ,public ,heal? ,s]vice ,act may1 to support ! approval or lic5sure 7z applicable7 ( ! use ( ! drug t is ! subject ( su* approv$ application = a new qualifi$ indication1 submit qualifi$ data summ>ies4 7b7 ,eligibility ,9 c>ry+ out ! /reaml9$ data review program "u subsection 7a71 ! ,secret>y may au?orize ! hold] ( ! approv$ application to include "o or m qualifi$ data summ>ies describ$ 9 subsection 7a7 9 a supplem5tal application if-- 7#a7 ! drug has be5 approv$ "u section #eje7;c7 ( ?is ,act or lic5s$ "u section #cea7;a7 ( ! ,public ,heal? ,s]vice ,act = "o or m indications1 & su* approval or lic5sure rema9s 9 effect2 7#b7 ! supplem5tal application is = approval or lic5sure 7z applicable7 "u su* section #eje7;c7 or #cea7;a7 ( ! use ( ! drug = a new qualifi$ indication "u su* section #eje7;c7 or #cea7;a72 7#c7 !re is an exi/+ database acceptable to ! ,secret>y reg>d+ ! safety ( ! drug develop$ = "o or m indications ( ! drug approv$ "u su* section #eje7;c7 or lic5s$ "u su* section #cea7;a72 7#d7 ! supplem5tal application incorporates or supplem5ts ! data submitt$ 9 ! application = approval or lic5sure ref]r$ to 9 p>agraph 7#a72 & 7#e7 ! full data sets us$ to develop ! qualifi$ data summ>ies are submitt$1 unless ! ,secret>y det]m9es t ! full data sets are n requir$4 7c7 ,public availability ( in=mation on program ,! ,secret>y %all po/ on ! public website ( ! ,food & ,drug ,adm9i/ration & update annually-- 7#a7 ! numb] ( applications review$ "u ! /reaml9$ data review program2 7#b7 ! av]age "t = completion ( review "u ! /reaml9$ data review program v]sus o!r review ( applications = new indications2 & 7#c7 ! numb] ( applications review$ "u ! /reaml9$ data review program = :i* ! ,food & ,drug ,adm9i/ration made use ( full data sets 9 addition to ! qualifi$ data summ>y4 7d7 ,def9itions ,9 ?is section3 7#a7 ,! t]m qualifi$ indication means-- 7,a7 an indication = ! treatm5t ( canc]1 z det]m9$ appropriate by ! ,secret>y2 or 7,b7 su* o!r types ( indications z ! ,secret>y det]m9es to be subject to ! /reaml9$ data review program "u ?is section4 7#b7 ,! t]m qualifi$ data summ>y means a summ>y ( cl9ical data int5d$ to demon/rate safety & effectiv5ess ) respect to a qualifi$ indication = use ( a drug4 4 7b7 ,s5se ( ,congress ,x is ! s5se ( ,congress t ! /reaml9$ data review program "u section #eje;,h ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act1 z add$ by subsection 7a71 %\ld enable ! ,food & ,drug ,adm9i/ration to make approval decisions = c]ta9 supplem5tal applications bas$ on qualifi$ data summ>ies 7z def9$ 9 su* section #eje;,h74 7c7 ,guidance2 regulations ,! ,commission] ( ,food & ,drugs-- 7#a7 %all-- 7,a7 issue f9al guidance = implem5tation ( ! /reaml9$ data review program e/abli%$ "u section #eje;,h ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act1 z add$ by subsection 7a71 n lat] ?an #bd mon?s aft] ! date ( enactm5t ( ?is ,act2 & 7,b7 include 9 su* guidance ! process = exp&+ ! types ( indications to be subject to ! /reaml9$ data review program1 z au?oriz$ by section #eje;,h7c77#a77;,b7 ( su* ,act2 & 7#b7 9 addition to issu+ guidance "u p>agraph 7#a71 may issue su* regulations z may be necess>y = implem5tation ( ! program4 ,e ,exp$it+ ,pati5t ,access #bjha4 ,s5se ( ,congress ,x is ! s5se ( ,congress t ! ,food & ,drug ,adm9i/ration %\ld cont9ue to exp$ite ! approval ( drugs designat$ z break?r\gh !rapies pursuant to section #ejf7;a7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cef7;a77 by approv+ drugs s designat$ z e>ly z possible 9 ! cl9ical developm5t process1 reg>dless ( ! phase ( developm5t1 provid$ t ! ,secret>y ( ,heal? & ,human ,s]vices det]m9es t an application = su* a drug meets ! /&>ds ( evid5ce ( safety & effectiv5ess "u section #eje ( su* ,act 7#ba ,u4,s4,c4 #cee71 includ+ ! sub/antial evid5ce /&>d "u subsection 7d7 ( su* section or "u section #cea7;a7 ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bfb7;a774 #bjhb4 ,exp&$ access policy ,*apt] ,v ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act is am5d$ by ins]t+ aft] section #efa 7#ba ,u4,s4,c4 #cfj;bbb7 ! foll[+3 #efa;,a4 ,exp&$ access policy requir$ = inve/igational drugs 7a7 ,9 g5]al ,! manufactur] or di/ributor ( "o or m inve/igational drugs = ! diagnosis1 monitor+1 or treatm5t ( "o or m s]i\s diseases or conditions %all make publicly available ! policy ( ! manufactur] or di/ributor on evaluat+ & respond+ to reque/s submitt$ "u section #efa7;b7 = provision ( su* a drug4 ,a manufactur] or di/ributor may satisfy ! requirem5t ( ! prec$+ s5t5ce by po/+ su* policy z g5]ally applicable to all ( su* manufactur]'s or di/ributor's inve/igational drugs4 7b7 ,cont5t ( policy ,a policy describ$ 9 subsection 7a7 %all include mak+ publicly available-- 7#a7 contact in=mation = ! manufactur] or di/ributor to facilitate communication ab\t reque/s describ$ 9 subsection 7a72 7#b7 proc$ures = mak+ su* reque/s2 7#c7 ! g5]al crit]ia ! manufactur] or di/ributor w consid] or use to approve su* reque/s2 & 7#d7 ! l5g? ( "t ! manufactur] or di/ributor anticipates w be necess>y to ackn[l$ge receipt ( su* reque/s4 7c7 ,no gu>antee ( access ,! po/+ ( policies by manufactur]s & di/ributors "u subsection 7a7 %all n s]ve z a gu>antee ( access to any specific inve/igational drug by any individual pati5t4 7d7 ,revis$ policy ,a manufactur] or di/ributor t has made a policy publicly available z requir$ by ?is section may revise ! policy at any "t4 7e7 ,application ,?is section %all apply to a manufactur] or di/ributor ) respect to an inve/igational drug beg9n+ on ! lat] (-- 7#a7 ! date t is #fj days aft] ! date ( enactm5t ( ! #ba/ ,c5tury ,cures ,act2 or 7#b7 ! fir/ initiation ( a phase #b or phase #c /udy 7z su* t]ms are def9$ 9 section #cab4ba7;b7 & 7c7 ( title #ba1 ,code ( ,f$]al ,regulations 7or any successor regulations77 ) respect to su* inve/igational new drug4 4 #bjhc4 ,f9aliz+ draft guidance on exp&$ access 7a7 ,9 g5]al ,n lat] ?an #ab mon?s aft] ! date ( enactm5t ( ?is ,act1 ! ,secret>y ( ,heal? & ,human ,s]vices %all f9alize ! draft guidance entitl$ ,exp&$ ,access to ,inve/igational ,drugs = ,treatm5t ,use--,qs ,z & dat$ ,may #bjac4 7b7 ,cont5ts ,! f9al guidance ref]r$ to 9 subsection 7a7 %all cle>ly def9e h[ ! ,secret>y ( ,heal? & ,human ,s]vices int]prets & uses adv]se drug ev5t data report$ by inve/igators 9 ! case ( data report$ f use "u a reque/ submitt$ "u section #efa7;b7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;bbb7b774 ,f ,facilitat+ responsible manufactur] communications #baja4 ,facilitat+ dissem9ation ( heal? c>e economic in=mation ,section #ejb7;a7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #ceb7;a77 is am5d$-- 7#a7 by /rik+ 7a7 ,if its & ins]t+ 7a77#a7 ,if its2 7#b7 by /rik+ a =mul>y committee1 or o!r simil> entity1 9 ! c\rse ( ! committee or ! entity c>ry+ out its responsibilities = ! selection ( drugs = manag$ c>e or o!r simil> organizations & ins]t+ a payor1 =mul>y committee1 or o!r simil> entity ) k & exp]tise 9 ! area ( heal? c>e economic analysis1 c>ry+ out its responsibilities = ! selection ( drugs = cov]age or reimbursem5t2 7#c7 by /rik+ directly relates & ins]t+ relates2 7#d7 by /rik+ & is bas$ on compet5t & reliable sci5tific evid5ce4 ,! requirem5ts set =? 9 section #eje7;a7 or 9 section #cea7;a7 ( ! ,public ,heal? ,s]vice ,act %all n apply to heal? c>e economic in=mation provid$ to su* a committee or entity 9 accordance ) ?is p>agraph & ins]t+ 1 is bas$ on compet5t & reliable sci5tific evid5ce1 & includes1 :]e applicable1 a conspicu\s & prom95t /atem5t describ+ any mat]ial diff]5ces betwe5 ! heal? c>e economic in=mation & ! label+ approv$ = ! drug "u section #eje or "u section #cea ( ! ,public ,heal? ,s]vice ,act4 ,! requirem5ts set =? 9 section #eje7;a7 or 9 subsections 7a7 & 7k7 ( section #cea ( ! ,public ,heal? ,s]vice ,act %all n apply to heal? c>e economic in=mation provid$ to su* a payor1 committee1 or entity 9 accordance ) ?is p>agraph2 & 7#e7 by /rik+ ,9 ?is p>agraph1 ! t]m & all t foll[s & ins]t+ ! foll[+3 7#b7 7,a7 ,= purposes ( ?is p>agraph1 ! t]m heal? c>e economic in=mation means any analysis 7includ+ ! cl9ical data1 inputs1 cl9ical or o!r assumptions1 me?ods1 results1 & o!r compon5ts und]ly+ or compris+ ! analysis7 t id5tifies1 measures1 or describes ! economic consequ5ces1 :i* may be bas$ on ! sep>ate or aggregat$ cl9ical consequ5ces ( ! repres5t$ heal? outcomes1 ( ! use ( a drug4 ,su* analysis may be comp>ative to ! use ( ano!r drug1 to ano!r heal? c>e int]v5tion1 or to no int]v5tion4 7,b7 ,su* t]m does n include any analysis t relates only to an indication t is n approv$ "u section #eje or "u section #cea ( ! ,public ,heal? ,s]vice ,act = su* drug4 4 #bajb4 ,facilitat+ responsible communication ( sci5tific & m$ical developm5ts 7a7 ,guidance ,n lat] ?an #ah mon?s aft] ! date ( enactm5t ( ?is ,act1 ! ,secret>y ( ,heal? & ,human ,s]vices %all issue draft guidance on facilitat+ ! responsible dissem9ation ( tru?ful & nonmislead+ sci5tific & m$ical in=mation n includ$ 9 ! approv$ label+ ( drugs & devices4 7b7 ,def9ition ,9 ?is section1 ! t]ms drug & device h ! mean+ giv5 to su* t]ms 9 section #bja ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cba74 ,g ,antibiotic ,drug ,developm5t #baba4 ,approval ( c]ta9 drugs = use 9 a limit$ population ( pati5ts 7a7 ,purpose ,! purpose ( ?is section is to help to exp$ite ! developm5t & availability ( treatm5ts = s]i\s or life-?reat5+ bact]ial or fungal infections 9 pati5ts ) unmet ne$s1 :ile ma9ta9+ safety & effectiv5ess /&>ds = su* treatm5ts1 tak+ into acc\nt ! sev]ity ( ! infection & ! availability or lack ( alt]native treatm5ts4 7b7 ,approval ( c]ta9 antibact]ial & antifungal drugs ,section #eje ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cee71 z am5d$ by section #bjja1 is fur!r am5d$ by add+ at ! end ! foll[+ new subsection3 7z7 ,approval ( c]ta9 antibact]ial & antifungal drugs = use 9 a limit$ population ( pati5ts 7#a7 ,process ,at ! reque/ ( ! sponsor ( an antibact]ial or antifungal drug t is int5d$ to treat a s]i\s or life-?reat5+ infection1 ! ,secret>y-- 7,a7 may execute a writt5 agreem5t ) ! sponsor on ! process = develop+ data to support an application = approval ( su* drug1 = use 9 a limit$ population ( pati5ts 9 accordance ) ?is subsection2 7,b7 %all proce$ 9 accordance ) ?is subsection only if a writt5 agreem5t is rea*$ "u subp>agraph 7,a72 7,c7 %all provide ! sponsor ) an opportunity to reque/ meet+s "u p>agraph 7#b72 7,d7 if a writt5 agreem5t is rea*$ "u subp>agraph 7,a71 may approve ! drug "u ?is subsection = su* use-- 7i7 9 a limit$ population ( pati5ts = :i* !re is an unmet m$ical ne$2 7ii7 bas$ on a /reaml9$ developm5t program2 & 7iii7 only if ! /&>ds = approval "u subsections 7c7 & 7d7 ( ?is section or lic5sure "u section #cea ( ! ,public ,heal? ,s]vice ,act1 z applicable1 are met2 & 7,e7 9 approv+ a drug 9 accordance ) ?is subsection1 subject to subp>agraph 7,d77iii71 may rely ^u-- 7i7 traditional endpo9ts1 alt]nate endpo9ts1 or a comb9ation ( traditional & alt]nate endpo9ts1 &1 z appropriate1 data sets ( a limit$ size2 & 7ii7 7,i7 additional data1 includ+ precl9ical1 ph>macologic1 or pa?ophysiologic evid5ce2 7,,ii7 noncl9ical susceptibility & ph>macok9etic data2 7,,iii7 data f phase #b cl9ical trials2 & 7,,iv7 su* o!r confirmatory evid5ce z ! ,secret>y det]m9es appropriate to approve ! drug4 7#b7 ,=mal meet+s 7,a7 ,9 g5]al ,to help to exp$ite & facilitate ! developm5t & review ( a drug = :i* a sponsor int5ds to reque/ approval 9 accordance ) ?is subsection1 ! ,secret>y may1 at ! reque/ ( ! sponsor1 conduct meet+s t provide e>ly consultation1 timely advice1 & suffici5t opportunities to develop an agreem5t describ$ 9 p>agraph 7#a77;,a7 & help ! sponsor design & conduct a drug developm5t program z effici5tly z possible1 includ+ ! foll[+ types ( meet+s3 7i7 ,an e>ly consultation meet+4 7ii7 ,an assessm5t meet+4 7iii7 ,a po/approval meet+4 7,b7 ,no alt]+ ( goals ,no?+ 9 ?is p>agraph %all be con/ru$ to alt] agre$-^u goals & proc$ures id5tifi$ 9 ! lett]s describ$ 9 section #aja7;b7 ( ! ,prescription ,drug ,us] ,fee ,am5dm5ts ( #bjab4 7,c7 ,break?r\gh !rapies ,9 ! case ( a drug designat$ z a break?r\gh !rapy "u section #ejf7;a71 ! sponsor ( su* drug may elect to utilize meet+s provid$ "u su* section ) respect to su* drug 9 lieu ( meet+s describ$ 9 subp>agraph 7,a74 7#c7 ,label+ requirem5t ,! label+ ( an antibact]ial or antifungal drug approv$ 9 accordance ) ?is subsection %all conta9 ! /atem5t ,limit$ ,population 9 a prom95t mann] & adjac5t to1 & n m prom95t ?an1 ! br& "n ( ! product4 ,! prescrib+ in=mation = su* antibact]ial or antifungal drug requir$ by section #bja4eg ( title #ba1 ,code ( ,f$]al ,regulations 7or any successor regulation7 %all also include ! foll[+ /atem5t3 ,?is drug is indicat$ = use 9 a limit$ & specific population ( pati5ts44 7#d7 ,promotional mat]ials ,! provisions ( section #ejf7;c77#b77;,b7 %all apply ) respect to approval 9 accordance ) ?is subsection to ! same ext5t & 9 ! same mann] z su* provisions apply ) respect to accel]at$ approval 9 accordance ) section #ejf7;c77#a74 7#e7 ,t]m9ation ( requirem5ts or conditions ,if a drug is approv$ 9 accordance ) ?is subsection = an indication 9 a limit$ population ( pati5ts & is subsequ5tly approv$ or lic5s$ "u ?is section or section #cea ( ! ,public ,heal? ,s]vice ,act1 o!r ?an 9 accordance ) ?is subsection1 =-- 7,a7 ! same indication & ! same conditions ( use1 ! ,secret>y %all remove any label+ requirem5ts or po/m>ket+ conditions t 7 made applicable to ! drug "u ?is subsection2 or 7,b7 a diff]5t indication or condition ( use1 ! ,secret>y %all n apply ! label+ requirem5ts & po/m>ket+ conditions t 7 made applicable to ! drug "u ?is subsection to ! subsequ5t approval ( ! drug = su* diff]5t indication or condition ( use4 7#f7 ,relation to o!r provisions ,no?+ 9 ?is subsection %all be con/ru$ to prohibit ! approval ( a drug = use 9 a limit$ population ( pati5ts 9 accordance ) ?is subsection1 9 comb9ation )-- 7,a7 an agreem5t on ! design & size ( a cl9ical trial pursuant to subp>agraphs 7,b7 & 7,c7 ( subsection 7b77#e72 7,b7 designation & treatm5t ( ! drug z a break?r\gh !rapy "u section #ejf7;a72 7,c7 designation & treatm5t ( ! drug z a fa/ track product "u section #ejf7;b72 or 7,d7 accel]at$ approval ( ! drug 9 accordance ) section #ejf7;c74 7#g7 ,rule ( con/ruction ,no?+ 9 ?is subsection %all be con/ru$-- 7,a7 to alt] ! /&>ds ( evid5ce "u subsection 7c7 or 7d7 7includ+ ! sub/antial evid5ce /&>d 9 subsection 7d772 7,b7 to waive or o!rwise preclude ! application ( requirem5ts "u subsection 7o72 7,c7 to o!rwise1 9 any way1 limit ! au?ority ( ! ,secret>y to approve products pursuant to ?is ,act & ! ,public ,heal? ,s]vice ,act z au?oriz$ prior to ! date ( enactm5t ( ?is subsection2 or 7,d7 to re/rict 9 any mann]1 ! prescrib+ ( antibiotics or o!r products by heal? c>e provid]s1 or to o!rwise limit or re/rict ! practice ( heal? c>e4 7#h7 ,effective imm$iately ,! ,secret>y %all h ! au?orities ve/$ 9 ! ,secret>y by ?is subsection beg9n+ on ! date ( enactm5t ( ?is subsection1 irrespective ( :5 & :e!r ! ,secret>y promulgates f9al regulations or guidance4 7#i7 ,def9itions ,9 ?is subsection3 7,a7 ,e>ly consultation meet+ ,! t]m e>ly consultation meet+ means a pre-inve/igational new drug meet+ or an end-(-phase-#a meet+ t-- 7i7 is conduct$ to review & rea* a writt5 agreem5t-- 7,i7 on ! scope ( ! /reaml9$ developm5t plan = a drug = :i* a sponsor int5ds to reque/ approval 9 accordance ) ?is subsection2 & 7,,ii7 :i*1 z appropriate1 may include agreem5t on ! design & size ( necess>y precl9ical & cl9ical /udies e>ly 9 ! developm5t process1 includ+ cl9ical trials ^: data are int5d$ to =m ! prim>y basis = an effectiv5ess claim2 & 7ii7 provides an opportunity to discuss expectations ( ! ,secret>y reg>d+ /udies or o!r in=mation t ! ,secret>y deems appropriate = purposes ( apply+ p>agraph 7#e71 relat+ to ! t]m9ation ( label+ requirem5ts or po/m>ket+ conditions4 7,b7 ,assessm5t meet+ ,! t]m assessm5t meet+ means an end-(-phase-#b meet+1 pre-new drug application meet+1 or pre-biologics lic5se application meet+ conduct$ to resolve que/ions & issues rais$ dur+ ! c\rse ( cl9ical inve/igations1 & details address$ 9 ! writt5 agreem5t reg>d+ po/approval commitm5ts or expansion ( approv$ uses4 7,c7 ,po/approval meet+ ,! t]m po/approval meet+ means a meet+ foll[+ initial approval or lic5sure ( ! drug = use 9 a limit$ population1 to discuss any issues id5tifi$ by ! ,secret>y or ! sponsor reg>d+ po/approval commitm5ts or expansion ( approv$ uses4 4 7c7 ,guidance ,n lat] ?an #ah mon?s aft] ! date ( enactm5t ( ?is ,act1 ! ,secret>y ( ,heal? & ,human ,s]vices1 act+ ?r\gh ! ,commission] ( ,food & ,drugs1 %all issue draft guidance describ+ crit]ia1 process1 & o!r g5]al consid]ations = demon/rat+ ! safety & effectiv5ess ( antibact]ial & antifungal drugs to be approv$ = use 9 a limit$ population 9 accordance ) section #eje7z7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act1 z add$ by subsection 7b74 7d7 ,con=m+ am5dm5ts 7#a7 ,lic5sure ( c]ta9 biological products ,section #cea7;j7 ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bfb7;j77 is am5d$-- 7,a7 by /rik+ 7j7 & ins]t+ 7j77#a72 7,b7 by ins]t+ #eje7z71 aft] #eje7p712 & 7,c7 by add+ at ! end ! foll[+ new p>agraph3 7#b7 ,9 apply+ section #eje7z7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act to ! lic5sure ( biological products "u ?is section-- 7,a7 ref]5ces to an antibact]ial or antifungal drug t is int5d$ to treat a s]i\s or life-?reat5+ infection %all be con/ru$ to ref] to a biological product int5d$ to treat a s]i\s or life-?reat5+ bact]ial or fungal infection2 & 7,b7 ref]5ces to approval ( a drug "u section #eje7;c7 ( su* ,act %all be con/ru$ to ref] to a lic5sure ( a biological product "u subsection 7a7 ( ?is section4 4 7#b7 ,misbr&+ ,section #ejb ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #ceb7 is am5d$ by add+ at ! end ! foll[+ new subsection3 7dd7 ,if x is a drug approv$ 9 accordance ) section #eje7z7 & its label+ does n meet ! requirem5ts "u p>agraph 7#c7 ( su* subsection1 subject to p>agraph 7#e7 ( su* subsection4 4 7e7 ,evaluation 7#a7 ,assessm5t ,n lat] ?an #dh mon?s aft] ! date ( enactm5t ( ?is ,act1 ! ,secret>y ( ,heal? & ,human ,s]vices %all publi% = public comm5t an assessm5t ( ! program e/abli%$ "u section #eje7z7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act1 z add$ by subsection 7b74 ,su* assessm5t %all det]m9e if ! limit$-use pa?way e/abli%$ "u su* section #eje7z7 has improv$ or is likely to improve pati5t access to novel antibact]ial or antifungal treatm5ts & assess h[ ! pa?way c\ld be exp&$ to cov] products = s]i\s or life-?reat5+ diseases or conditions beyond bact]ial & fungal infections4 7#b7 ,meet+ ,n lat] ?an #ij days aft] ! date ( ! publication ( su* assessm5t1 ! ,secret>y1 act+ ?r\gh ! ,commission] ( ,food & ,drugs1 %all hold a public meet+ to discuss ! f9d+s ( ! assessm5t1 dur+ :i* public /akehold]s may pres5t _! views on ! success ( ! program e/abli%$ "u section #eje7z7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act1 z add$ by subsection 7b71 & ! appropriat5ess ( exp&+ su* program4 7f7 ,expansion ( program ,if ! ,secret>y ( ,heal? & ,human ,s]vices det]m9es1 bas$ on ! assessm5t "u subsection 7e77#a71 evaluation ( ! assessm5t1 & any o!r relevant in=mation1 t ! public heal? w\ld b5efit f expansion ( ! limit$-use pa?way e/abli%$ "u section #eje7z7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7z add$ by subsection 7b77 beyond ! drugs approv$ 9 accordance ) su* section1 ! ,secret>y may exp& su* limit$-use pa?way 9 accordance ) su* a det]m9ation4 ,! approval ( any drugs "u any su* expansion %all be subject to ! consid]ations & requirem5ts describ$ 9 su* section #eje7z7 = purposes ( expansion to o!r s]i\s or life-?reat5+ diseases or conditions4 7g7 ,monitor+ ,! ,public ,heal? ,s]vice ,act is am5d$ by ins]t+ aft] section #cag,t 7#db ,u4,s4,c4 #bdg;b-#bb7 ! foll[+3 #cag,u4 ,monitor+ antibact]ial & antifungal drug use & resi/ance 7a7 ,monitor+ ,! ,secret>y %all use an appropriate monitor+ sy/em to monitor-- 7#a7 ! use ( antibact]ial & antifungal drugs1 includ+ ^? receiv+ approval or lic5sure = a limit$ population pursuant to section #eje7z7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act2 & 7#b7 *anges 9 bact]ial & fungal resi/ance to drugs4 7b7 ,public availability ( data ,! ,secret>y %all make summ>ies ( ! data d]iv$ f monitor+ "u ?is section publicly available = ! purposes (-- 7#a7 improv+ ! monitor+ ( important tr5ds 9 antibact]ial & antifungal resi/ance2 & 7#b7 ensur+ appropriate /ew>d%ip ( antibact]ial & antifungal drugs1 includ+ ^? receiv+ approval or lic5sure = a limit$ population pursuant to section #eje7z7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act4 4 #babb4 ,susceptibility te/ int]pretive crit]ia = microorganisms 7a7 ,9 g5]al ,section #eaa ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;a7 is am5d$ to read z foll[s3 #eaa4 ,id5tify+ & updat+ susceptibility te/ int]pretive crit]ia = microorganisms 7a7 ,purpose2 ,id5tification ( crit]ia 7#a7 ,purpose ,! purpose ( ?is section is to provide ! ,secret>y ) an exp$it$1 flexible me?od =-- 7,a7 cle>ance or prem>ket approval ( antimicrobial susceptibility te/+ devices utiliz+ updat$1 recogniz$ susceptibility te/ int]pretive crit]ia to *>act]ize ! 9 vitro susceptibility ( p>ticul> bact]ia1 fungi1 or o!r microorganisms to antimicrobial drugs2 & 7,b7 provid+ public notice ( ! availability ( recogniz$ int]pretive crit]ia to meet prem>ket submission requirem5ts or o!r requirem5ts "u ?is ,act = antimicrobial susceptibility te/+ devices4 7#b7 ,9 g5]al ,! ,secret>y %all id5tify appropriate susceptibility te/ int]pretive crit]ia ) respect to antimicrobial drugs-- 7,a7 if su* crit]ia are available on ! date ( approval ( ! drug "u section #eje ( ?is ,act or lic5sure ( ! drug "u section #cea ( ! ,public ,heal? ,s]vice ,act 7z applicable71 ^u su* approval or lic5sure2 or 7,b7 if su* crit]ia are unavailable on su* date1 on ! date on :i* su* crit]ia are available = su* drug4 7#c7 ,bases = initial id5tification ,! ,secret>y %all id5tify appropriate susceptibility te/ int]pretive crit]ia "u p>agraph 7#b71 bas$ on ! ,secret>y's review (1 to ! ext5t available & relevant-- 7,a7 precl9ical & cl9ical data1 includ+ ph>macok9etic1 ph>macodynamic1 & epidemiological data2 7,b7 ,bayesian & ph>macometric /ati/ical me?odologies2 & 7,c7 su* o!r evid5ce & in=mation z ! ,secret>y consid]s appropriate4 7b7 ,susceptibility te/ ,int]pretive ,crit]ia ,website 7#a7 ,9 g5]al ,n lat] ?an #a ye> aft] ! date ( ! enactm5t ( ! #ba/ ,c5tury ,cures ,act1 ! ,secret>y %all e/abli%1 & ma9ta9 !reaft]1 on ! website ( ! ,food & ,drug ,adm9i/ration1 a d$icat$ website t conta9s a li/ ( any appropriate new or updat$ susceptibility te/ int]pretive crit]ia /&>ds 9 accordance ) p>agraph 7#b7 7ref]r$ to 9 ?is section z ! ,int]pretive ,crit]ia ,website74 7#b7 ,li/+ ( susceptibility te/ int]pretive crit]ia /&>ds 7,a7 ,9 g5]al ,! li/ describ$ 9 p>agraph 7#a7 %all consi/ ( any new or updat$ susceptibility te/ int]pretive crit]ia /&>ds t are-- 7i7 e/abli%$ by a nationally or int]nationally recogniz$ /&>d developm5t organization t-- 7,i7 e/abli%es & ma9ta9s proc$ures to address pot5tial conflicts ( int]e/ & ensure transp>5t decisionmak+2 7,,ii7 holds op5 meet+s to ensure t !re is an opportunity = public input by int]e/$ p>ties1 & e/abli%es & ma9ta9s processes to ensure t su* input is consid]$ 9 decisionmak+2 & 7,,iii7 p]mits its /&>ds to be made publicly available1 ?r\gh ! ,national ,libr>y ( ,m$ic9e or ano!r simil> s\rce acceptable to ! ,secret>y2 & 7ii7 recogniz$ 9 :ole1 or 9 "p1 by ! ,secret>y "u subsection 7c74 7,b7 ,o!r li/ ,! ,int]pretive ,crit]ia ,website %all1 9 addition to ! li/ describ$ 9 subp>agraph 7,a71 include a li/ ( int]pretive crit]ia1 if any1 t ! ,secret>y has det]m9$ to be appropriate ) respect to legally m>ket$ antimicrobial drugs1 :]e-- 7i7 ! ,secret>y does n recognize1 9 :ole or 9 "p1 an int]pretive crit]ia /&>d describ$ "u subp>agraph 7,a7 o!rwise applicable to su* a drug2 7ii7 ! ,secret>y )draws "u subsection 7c77#a77;,b7 recognition ( a /&>d1 9 :ole or 9 "p1 o!rwise applicable to su* a drug2 7iii7 ! ,secret>y approves an application "u section #eje ( ?is ,act or section #cea ( ! ,public ,heal? ,s]vice ,act1 z applicable1 ) respect to m>ket+ ( su* a drug = :i* !re are no relevant int]pretive crit]ia includ$ 9 a /&>d recogniz$ by ! ,secret>y "u subsection 7c72 or 7iv7 because ! *>act]i/ics ( su* a drug diff] f o!r drugs ) ! same active +r$i5t1 ! int]pretive crit]ia ) respect to su* drug-- 7,i7 diff] f o!rwise applicable int]pretive crit]ia includ$ 9 a /&>d li/$ "u subp>agraph 7,a7 or int]pretive crit]ia o!rwise li/$ "u ?is subp>agraph2 & 7,,ii7 are det]m9$ by ! ,secret>y to be appropriate = ! drug4 7,c7 ,requir$ /atem5ts ( limitations ( in=mation ,! ,int]pretive ,crit]ia ,website %all include ! foll[+3 7i7 ,a /atem5t t-- 7,i7 ! website provides in=mation ab\t ! susceptibility ( bact]ia1 fungi1 or o!r microorganisms to a c]ta9 drug 7or drugs72 & 7,,ii7 ! safety & efficacy ( ! drug 9 treat+ cl9ical infections due to su* bact]ia1 fungi1 or o!r microorganisms may n h be5 e/abli%$ 9 adequate & well-controll$ cl9ical trials & ! cl9ical significance ( su* susceptibility in=mation 9 su* trials is unkn[n4 7ii7 ,a /atem5t t directs heal? c>e practition]s to consult ! approv$ product label+ = specific drugs to det]m9e ! uses = :i* ! ,food & ,drug ,adm9i/ration has approv$ ! product4 7iii7 ,any o!r /atem5t t ! ,secret>y det]m9es appropriate to adequately convey ! limitations ( ! data support+ susceptibility te/ int]pretive crit]ia /&>d li/$ on ! website4 7#c7 ,notice ,n lat] ?an ! date on :i* ! ,int]pretive ,crit]ia ,website is e/abli%$1 ! ,secret>y %all publi% a notice ( t e/abli%m5t 9 ! ,f$]al ,regi/]4 7#d7 ,inapplicability ( misbr&+ provision ,! inclusion 9 ! approv$ label+ ( an antimicrobial drug ( a ref]5ce or hyp]l9k to ! ,int]pretive ,crit]ia ,website1 9 & ( itself1 %all n cause ! drug to be misbr&$ 9 violation ( section #ejb1 or ! regulations promulgat$ !reund]4 7#e7 ,trade secrets & confid5tial in=mation ,no?+ 9 ?is section %all be con/ru$ z au?oriz+ ! ,secret>y to disclose any in=mation t is a trade secret or confid5tial in=mation subject to section #eeb7;b77#d7 ( title #e1 ,unit$ ,/ates ,code4 7c7 ,recognition ( susceptibility te/ int]pretive crit]ia f /&>d developm5t organizations 7#a7 ,9 g5]al ,beg9n+ on ! date ( ! e/abli%m5t ( ! ,int]pretive ,crit]ia ,website1 & at lea/ e #f mon?s !reaft]1 ! ,secret>y %all-- 7,a7 evaluate any appropriate new or updat$ susceptibility te/ int]pretive crit]ia /&>ds e/abli%$ by a nationally or int]nationally recogniz$ /&>d developm5t organization describ$ 9 subsection 7b77#b77;,a77i72 & 7,b7 publi% on ! public website ( ! ,food & ,drug ,adm9i/ration a notice-- 7i7 )draw+ recognition ( any diff]5t susceptibility te/ int]pretive crit]ia /&>d1 9 :ole or 9 "p2 7ii7 recogniz+ ! new or updat$ /&>ds2 7iii7 recogniz+ "o or m p>ts ( ! new or updat$ int]pretive crit]ia specifi$ 9 su* a /&>d & decl9+ to recognize ! rema9d] ( su* /&>d2 & 7iv7 mak+ any necess>y updates to ! li/s "u subsection 7b77#b74 7#b7 ,bases = updat+ int]pretive crit]ia /&>ds ,9 evaluat+ new or updat$ susceptibility te/ int]pretive crit]ia /&>ds "u p>agraph 7#a77;,a71 ! ,secret>y may consid]-- 7,a7 ! ,secret>y's det]m9ation t su* a /&>d is n applicable to a p>ticul> drug because ! *>act]i/ics ( ! drug diff] f o!r drugs ) ! same active +r$i5t2 7,b7 in=mation provid$ by int]e/$ ?ird p>ties1 includ+ public comm5t on ! annual compilation ( notices publi%$ "u p>agraph 7#c72 7,c7 any bases us$ to id5tify susceptibility te/ int]pretive crit]ia "u subsection 7a77#b72 & 7,d7 su* o!r in=mation or factors z ! ,secret>y det]m9es appropriate4 7#c7 ,annual compilation ( notices ,ea* ye>1 ! ,secret>y %all compile ! notices publi%$ "u p>agraph 7#a77;,b7 & publi% su* compilation 9 ! ,f$]al ,regi/] & provide = public comm5t4 ,if ! ,secret>y receives comm5ts1 ! ,secret>y %all review su* comm5ts &1 if ! ,secret>y det]m9es appropriate1 update pursuant to ?is subsection susceptibility te/ int]pretive crit]ia /&>ds-- 7,a7 recogniz$ by ! ,secret>y "u ?is subsection2 or 7,b7 o!rwise li/$ on ! ,int]pretive ,crit]ia ,website "u subsection 7b77#b74 7#d7 ,relation to section #ead7;c7 ,any susceptibility te/ int]pretive /&>d recogniz$ "u ?is subsection or any crit]ia o!rwise li/$ "u subsection 7b77#b77;,b7 %all be deem$ to be recogniz$ z a /&>d by ! ,secret>y "u section #ead7;c77#a74 7#e7 ,volunt>y use ( int]pretive crit]ia ,no?+ 9 ?is section prohibits a p]son f seek+ approval or cle>ance ( a drug or device1 or *anges to ! drug or ! device1 on ! basis ( susceptibility te/ int]pretive crit]ia /&>ds :i* diff] f ^? recogniz$ pursuant to p>agraph 7#a74 7d7 ,antimicrobial drug label+ 7#a7 ,drugs m>ket$ prior to e/abli%m5t ( ,int]pretive ,crit]ia ,website ,) respect to an antimicrobial drug lawfully introduc$ or deliv]$ = introduction into int]/ate comm]ce = comm]cial di/ribution be=e ! e/abli%m5t ( ! ,int]pretive ,crit]ia ,website1 a hold] ( an approv$ application "u section #eje ( ?is ,act or section #cea ( ! ,public ,heal? ,s]vice ,act1 z applicable1 = ea* su* drug-- 7,a7 n lat] ?an #a ye> aft] e/abli%m5t ( ! ,int]pretive ,crit]ia ,website1 %all submit to ! ,secret>y a supplem5tal application = purposes ( *ang+ ! drug's label+ to sub/itute a ref]5ce or hyp]l9k to su* ,website = any susceptibility te/ int]pretive crit]ia & relat$ in=mation2 & 7,b7 may beg9 di/ribution ( ! drug involv$ ^u receipt by ! ,secret>y ( ! supplem5tal application = su* *ange4 7#b7 ,drugs m>ket$ subsequ5t to e/abli%m5t ( ,int]pretive ,crit]ia ,website ,) respect to antimicrobial drugs lawfully introduc$ or deliv]$ = introduction into int]/ate comm]ce = comm]cial di/ribution on or aft] ! date ( ! e/abli%m5t ( ! ,int]pretive ,crit]ia ,website1 ! label+ = su* a drug %all include1 9 lieu ( susceptibility te/ int]pretive crit]ia & relat$ in=mation1 a ref]5ce to su* ,website4 7e7 ,special condition = m>ket+ ( antimicrobial susceptibility te/+ devices 7#a7 ,9 g5]al ,not)/&+ sections #eja1 #ejb1 #eaj1 #eac1 & #eae1 if ! conditions specifi$ 9 p>agraph 7#b7 are met 79 addition to o!r applicable provisions "u ?is *apt]7 ) respect to an antimicrobial susceptibility te/+ device describ$ 9 subsection 7f77#a71 ! ,secret>y may au?orize ! m>ket+ ( su* device = a use describ$ 9 su* subsection4 7#b7 ,conditions applicable to antimicrobial susceptibility te/+ devices ,! conditions specifi$ 9 ?is p>agraph are ! foll[+3 7,a7 ,! device is us$ to make a det]m9ation ( susceptibility us+ susceptibility te/ int]pretive crit]ia t are-- 7i7 includ$ 9 a /&>d recogniz$ by ! ,secret>y "u subsection 7c72 or 7ii7 o!rwise li/$ on ! ,int]pretive ,crit]ia ,website "u subsection 7b77#b74 7,b7 ,! label+ ( su* device prom95tly & conspicu\sly-- 7i7 includes a /atem5t t-- 7,i7 ! device provides in=mation ab\t ! susceptibility ( bact]ia & fungi to c]ta9 drugs2 & 7,,ii7 ! safety & efficacy ( su* drugs 9 treat+ cl9ical infections due to su* bact]ia or fungi may n h be5 e/abli%$ 9 adequate & well-controll$ cl9ical trials & ! cl9ical significance ( su* susceptibility in=mation 9 ^? in/ances is unkn[n2 7ii7 includes a /atem5t direct+ heal? c>e practition]s to consult ! approv$ label+ = drugs te/$ us+ su* a device1 to det]m9e ! uses = :i* ! ,food & ,drug ,adm9i/ration has approv$ su* drugs2 & 7iii7 includes any o!r /atem5t ! ,secret>y det]m9es appropriate to adequately convey ! limitations ( ! data support+ ! int]pretive crit]ia describ$ 9 subp>agraph 7,a74 7f7 ,def9itions ,9 ?is section3 7#a7 ,! t]m antimicrobial susceptibility te/+ device means a device t utilizes susceptibility te/ int]pretive crit]ia to det]m9e & report ! 9 vitro susceptibility ( c]ta9 microorganisms to a drug 7or drugs74 7#b7 ,! t]m qualifi$ infecti\s disease product means a qualifi$ infecti\s disease product designat$ "u section #eje;,e7d74 7#c7 ,! t]m susceptibility te/ int]pretive crit]ia means-- 7,a7 "o or m specific num]ical values :i* *>act]ize ! susceptibility ( bact]ia or o!r microorganisms to ! drug te/$2 & 7,b7 relat$ categorizations ( su* susceptibility1 includ+ categorization ( ! drug z susceptible1 int]m$iate1 resi/ant1 or su* o!r t]m z ! ,secret>y det]m9es appropriate4 7#d7 7,a7 ,! t]m antimicrobial drug means1 subject to subp>agraph 7,b71 a sy/emic antibact]ial or antifungal drug t-- 7i7 is int5d$ = human use 9 ! treatm5t ( a disease or condition caus$ by a bact]ium or fungus2 7ii7 may include a qualifi$ infecti\s disease product designat$ "u section #eje;,e7d72 & 7iii7 is subject to section #ejc7;b77#a74 7,b7 ,if provid$ by ! ,secret>y ?r\gh regulations1 su* t]m may include-- 7i7 drugs o!r ?an sy/emic antibact]ial & antifungal drugs2 & 7ii7 biological products 7z su* t]m is def9$ 9 section #cea ( ! ,public ,heal? ,s]vice ,act7 to ! ext5t su* products exhibit antimicrobial activity4 7g7 ,rule ( con/ruction ,no?+ 9 ?is section %all be con/ru$-- 7#a7 to alt] ! /&>ds ( evid5ce-- 7,a7 "u subsection 7c7 or 7d7 ( section #eje1 includ+ ! sub/antial evid5ce /&>d 9 section #eje7;d71 or "u section #cea ( ! ,public ,heal? ,s]vice ,act 7z applicable72 or 7,b7 ) respect to m>ket+ au?orization = devices1 "u section #eaj1 #eac1 or #eae2 7#b7 to apply ) respect to any drug1 device1 or biological product1 9 any context o!r ?an-- 7,a7 an antimicrobial drug2 or 7,b7 an antimicrobial susceptibility te/+ device t uses susceptibility te/ int]pretive crit]ia to *>act]ize & report ! 9 vitro susceptibility ( c]ta9 bact]ia1 fungi1 or o!r microorganisms to antimicrobial drugs 9 accordance ) ?is section2 or 7#c7 unless specifically /at$1 to h any effect on au?orities provid$ "u o!r sections ( ?is ,act1 includ+ any regulations issu$ "u su* sections4 4 7b7 ,con=m+ am5dm5ts 7#a7 ,repeal ( relat$ au?ority ,section #aaaa ( ! ,food & ,drug ,adm9i/ration ,am5dm5ts ,act ( #bjjg 7#db ,u4,s4,c4 #bdg;d-#e;a2 relat+ to id5tification ( cl9ically susceptible conc5trations ( antimicrobials7 is repeal$4 7#b7 ,cl]ical am5dm5t ,! table ( cont5ts 9 section #b ( ! ,food & ,drug ,adm9i/ration ,am5dm5ts ,act ( #bjjg is am5d$ by /rik+ ! item relat+ to section #aaaa4 7#c7 ,misbr&+ ,section #ejb ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #ceb71 z am5d$ by section #baba1 is fur!r am5d$ by add+ at ! end ! foll[+3 7ee7 ,if x is an antimicrobial drug & its label+ fails to con=m ) ! requirem5ts "u section #eaa7;d74 4 7#d7 ,recognition ( int]pretive crit]ia z device /&>d ,section #ead7;c77#a77;,a7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;d7c77#a77;,a77 is am5d$ by ins]t+ aft] ! ,secret>y %all1 by publication 9 ! ,f$]al ,regi/] ! foll[+3 7or1 ) respect to susceptibility te/ int]pretive crit]ia or /&>ds recogniz$ or o!rwise li/$ "u section #eaa1 by po/+ on ! ,int]pretive ,crit]ia ,website 9 accordance ) su* section74 7c7 ,report to ,congress ,n lat] ?an #b ye>s aft] ! date ( enactm5t ( ?is ,act1 ! ,secret>y ( ,heal? & ,human ,s]vices %all submit to ! ,committee on ,en]gy & ,comm]ce ( ! ,h\se ( ,repres5tatives & ! ,committee on ,heal?1 ,education1 ,labor1 & ,p5sions ( ! ,s5ate a report on ! progress made 9 implem5t+ section #eaa ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;a71 z am5d$ by ?is section4 7d7 ,reque/s = updates to ,int]pretive ,crit]ia ,website ,*apt] #ce ( title #dd1 ,unit$ ,/ates ,code1 %all n apply to ! collection ( in=mation f int]e/$ p>ties reg>d+ ! updat+ ( li/s "u p>agraph 7#b7 ( subsection 7b7 section #eaa ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7z am5d$ by subsection 7a77 & po/$ on ! ,int]pretive ,crit]ia ,website e/abli%$ "u p>agraph 7#a7 ( su* subsection 7b74 7e7 ,no effect on heal? c>e practice ,no?+ 9 ?is subtitle 7includ+ ! am5dm5ts made by ?is subtitle7 %all be con/ru$ to re/rict1 9 any mann]1 ! prescrib+ or adm9i/]+ ( antibiotics or o!r products by heal? c>e practition]s1 or to limit ! practice ( heal? c>e4 #babc4 ,enc\rag+ ! developm5t & use ( ,,dis>m drugs 7a7 ,additional paym5t = ,,dis>m drugs "u ,m$ic>e 7#a7 ,9 g5]al ,section #ahhf7;d77#e7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acieww7d77#e77 is am5d$ by add+ at ! end ! foll[+ new subp>agraph3 7,m7 7i7 ,z "p ( ! annual rulemak+ conduct$ ) respect to paym5t = subsection 7d7 hospitals = ea* fiscal ye> beg9n+ ) fiscal ye> #bjah1 ! ,secret>y %all-- 7,i7 include a li/ ( ! ,,dis>m drugs = su* fiscal ye>2 & 7,,ii7 ) respect to dis*>ges by eligible hospitals t involve a drug s li/$1 provide = an additional paym5t to be made "u ?is subsection 9 accordance ) ! provisions ( ?is subp>agraph4 7ii7 ,additional paym5ts may n be made = a drug "u ?is subp>agraph-- 7,i7 o!r ?an dur+ ! #e-;fiscal-ye> p]iod beg9n+ ) ! fiscal ye> = :i* ! drug is fir/ includ$ 9 ! li/ describ$ 9 clause 7i77,i72 & 7,,ii7 ) respect to :i* paym5t has ev] be5 made pursuant to subp>agraph 7,k74 7iii7 ,= purposes ( ?is subp>agraph1 ! t]m ,,dis>m drug means a product t is approv$ = use1 or a product = :i* an indication is fir/ approv$ = use1 by ! ,food & ,drug ,adm9i/ration on or aft] ,decemb] #a1 #bjad1 & t ! ,food & ,drug ,adm9i/ration det]m9es is an antimicrobial product 7z def9$ 9 clause 7iv77 & is int5d$ to treat an infection-- 7,i7 = :i* !re is an unmet m$ical ne$2 & 7,,ii7 :i* is associat$ ) high rates ( mortality or significant pati5t morbidity1 z det]m9$ 9 consultation ) ! ,director ( ! ,c5t]s = ,disease ,control & ,prev5tion & ! infecti\s disease pr(essional community4 7iv7 ,= purposes ( clause 7iii71 ! t]m antimicrobial product means a product t ei!r-- 7,i7 is int5d$ to treat an infection caus$ by1 or likely to be caus$ by1 a qualify+ pa?og5 7z def9$ "u section #eje;,e7f7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act72 or 7,,ii7 meets ! def9ition ( a qualifi$ infecti\s disease product "u section #eje;,e7g7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act4 ,su* det]m9ation may be revok$ only ^u a f9d+ t ! reque/ = su* det]m9ation conta9$ an untrue /atem5t ( mat]ial fact4 7v7 ,= purposes ( ?is subp>agraph1 ! t]m eligible hospital means a subsection 7d7 hospital t p>ticipates 9 ! ,national ,heal?c>e ,safety ,network ( ! ,c5t]s = ,disease ,control & ,prev5tion 7or1 to ! ext5t a simil> surveillance sy/em t includes report+ ab\t antimicrobial drugs is det]m9$ by ! ,secret>y to be available to su* hospitals1 su* simil> surveillance sy/em z ! ,secret>y may specify74 7vi7 ,subject to ! succe$+ provisions ( ?is subp>agraph1 ! additional paym5t "u ?is subp>agraph1 ) respect to a drug1 %all be 9 ! am\nt provid$ = su* drug "u section #ahdg;,a4 7vii7 ,z "p ( ! rulemak+ ref]r$ to 9 clause 7i7 = ea* fiscal ye>1 ! ,secret>y %all e/imate-- 7,i7 total add-on paym5ts 7z def9$ 9 subclause 7,i7 ( clause 7ix772 & 7,,ii7 total hospital paym5ts 7z def9$ 9 subclause 7,,ii7 ( su* clause74 7viii7 ,if ! total add-on paym5ts e/imat$ pursuant to clause 7vii77,i7 = a fiscal ye> exce$ #j4jb p]c5t ( ! total hospital paym5ts e/imat$ pursuant to clause 7vii77,,ii7 = su* fiscal ye>1 ! ,secret>y %all r$uce 9 a pro rata mann] ! am\nt ( ea* additional paym5t "u ?is subsection pursuant to ?is subp>agraph = su* fiscal ye> 9 ord] to ensure t ! total add-on paym5ts e/imat$ = su* fiscal ye> d n exce$ #j4jb p]c5t ( ! total hospital paym5ts e/imat$ = su* fiscal ye>4 7ix7 ,9 ?is subp>agraph3 7,i7 ,! t]m total add-on paym5ts means1 ) respect to a fiscal ye>1 ! total am\nt ( ! additional paym5ts "u ?is subsection pursuant to ?is subp>agraph = dis*>ges 9 su* fiscal ye> )\t reg>d to ! application ( clause 7viii74 7,,ii7 ,! t]m total hospital paym5ts means1 ) respect to a fiscal ye>1 ! total am\nt ( paym5ts made "u ?is subsection = all dis*>ges 9 su* fiscal ye>4 4 7#b7 ,con=m+ am5dm5ts 7,a7 ,no duplicative ,,ntap paym5ts ,section #ahhf7;d77#e77,k77vi7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acieww7d77#e77,k77vi77 is am5d$ by ins]t+ & if additional paym5t has nev] be5 made "u ?is subsection pursuant to subp>agraph 7,m7 ) respect to ! s]vice or te*nology be=e ! p]iod at ! end4 7,b7 ,access to price in=mation ,section #aibg7;b77#c77;,a7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acifr-#h7;b77#c77;,a77 is am5d$-- 7i7 9 clause 7ii7-- 7,i7 by /rik+ = ea* & ins]t+ 1 = ea*2 & 7,,ii7 by /rik+ & at ! end2 7ii7 9 clause 7iii7-- 7,i7 9 subclause 7,,ii71 by ins]t+ or "u section #ahhf7;d7 pursuant to p>agraph 7#e77,m7 ( su* section1 aft] #ahdg;,a12 7,,ii7 9 ! matt] foll[+ subclause 7,,iii71 by /rik+ or #ahha7;b77#ac77;,a77ii7 & ins]t+ 1 section #ahha7;b77#ac77;,a77ii71 or section #ahhf7;d77#e77,m72 & 7,,iii7 by /rik+ ! p]iod at ! end & ins]t+ 2 &2 & 7iii7 9 clause 7iv71 by /rik+ ! semicolon at ! end & ins]t+ a p]iod4 7b7 ,/udy & report on remov+ b>ri]s to developm5t ( ,,dis>m drugs 7#a7 ,/udy ,! ,comptroll] ,g5]al ( ! ,unit$ ,/ates %all1 9 consultation ) ! ,director ( ! ,national ,in/itutes ( ,heal?1 ! ,commission] ( ,food & ,drugs1 & ! ,director ( ! ,c5t]s = ,disease ,control & ,prev5tion1 conduct a /udy to-- 7,a7 id5tify & exam9e ! b>ri]s t prev5t ! developm5t ( ,,dis>m drugs1 z def9$ 9 section #ahhf7;d77#e77,m77iii7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acieww7d77#e77,m77iii771 z add$ by subsection 7a77#a72 & 7,b7 develop recomm5dations = actions to be tak5 9 ord] to ov]come any b>ri]s id5tifi$ "u subp>agraph 7,a74 7#b7 ,report ,n lat] ?an #a ye> aft] ! date ( ! enactm5t ( ?is ,act1 ! ,comptroll] ,g5]al %all submit to ,congress a report on ! /udy conduct$ "u p>agraph 7#a74 7c7 ,/udy & report on ! impact ( additional ,m$ic>e paym5t = ,,dis>m drugs on usage practices & developm5t ( resi/ance 7#a7 ,/udy ,! ,director ( ! ,c5t]s = ,disease ,control & ,prev5tion %all conduct a /udy to exam9e ! effects ( ! additional paym5t = ,,dis>m drugs "u ! ,m$ic>e ,program provid$ "u subp>agraph 7,m7 ( section #ahhf7;d77#e7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acieww7d77#e771 z add$ by subsection 7a71 on-- 7,a7 ! usage ( ,,dis>m drugs 7z def9$ by clause 7iii7 ( su* subp>agraph7 by subsection 7d7 hospitals 7z def9$ 9 section #ahhf7;d77#a77;,b7 ( su* ,act72 & 7,b7 ! developm5t ( resi/ance by individuals to su* ,,dis>m drugs4 7#b7 ,report ,n lat] ?an #c ye>s aft] ! date ( ! enactm5t ( ?is ,act1 su* ,director %all submit to ,congress a report on ! /udy conduct$ "u p>agraph 7#a74 ,h ,vacc9e ,access1 ,c]ta9ty1 & ,innovation #bada4 ,timely review ( vacc9es by ! ,advisory ,committee on ,immunization ,practices ,section #bajb7;a7 ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #cjj;aa-#b7;a77 is am5d$ by add+ at ! end ! foll[+3 7#aj7 ,advisory ,committee on ,immunization ,practices 7,a7 ,/&>d p]iods ( "t = mak+ recomm5dations ,^u ! lic5sure ( any vacc9e or any new indication = a vacc9e1 ! ,director ( ! ,program %all direct ! ,advisory ,committee on ,immunization ,practices1 at its next regul>ly s*$ul$ meet+1 to consid] ! use ( ! vacc9e4 7,b7 ,exp$it$ review pursuant to reque/ by sponsor or manufactur] ,if ! ,advisory ,committee does n make recomm5dations ) respect to ! use ( a vacc9e at ! ,advisory ,committee's fir/ regul>ly s*$ul$ meet+ aft] ! lic5sure ( ! vacc9e or any new indication = ! vacc9e1 ! ,advisory ,committee1 at ! reque/ ( ! sponsor ( ! vacc9e1 %all make su* recomm5dations on an exp$it$ basis4 7,c7 ,exp$it$ review = break?r\gh !rapies & = use dur+ public heal? em]g5cies ,if a vacc9e is designat$ z a break?r\gh !rapy "u section #ejf ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act1 & is lic5s$ "u section #cea ( ?is ,act1 ! ,advisory ,committee %all make recomm5dations ) respect to ! use ( ! vacc9e on an exp$it$ basis4 7,d7 ,def9ition ,9 ?is p>agraph1 ! t]ms ,advisory ,committee on ,immunization ,practices & ,advisory ,committee mean ! advisory committee on immunization practices e/abli%$ by ! ,secret>y pursuant to section #bbb1 act+ ?r\gh ! ,director ( ! ,c5t]s = ,disease ,control & ,prev5tion4 4 #badb4 ,review ( processes & consi/5cy ( ,,acip recomm5dations 7a7 ,review ,! ,director ( ! ,c5t]s = ,disease ,control & ,prev5tion %all conduct a review ( ! process us$ by ! ,advisory ,committee on ,immunization ,practices to evaluate consi/5cy 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 consi/5t among gr\ps4 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 #ah mon?s 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+ ! 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 #badc4 ,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 7i7 ! developm5t ( a vacc9e ) ! int5t to pursue lic5s+ ( ! vacc9e by ! ,food & ,drug ,adm9i/ration2 or 7ii7 ! production ( a vacc9e lic5s$ by ! ,food & ,drug ,adm9i/ration2 & 7,b7 vacc9e rese>*4 7#b7 7,a7 ,^u ! submission ( a writt5 reque/ = a meet+ by a vacc9e develop]1 t includes a valid ju/ification = ! meet+1 ! ,secret>y1 act+ ?r\gh ! ,director ( ! ,c5t]s = ,disease ,control & ,prev5tion1 %all conv5e a meet+ ( repres5tatives ( ! vacc9e develop] & exp]ts f ! ,c5t]s = ,disease ,control & ,prev5tion 9 immunization programs1 epidemiology1 & o!r relevant areas 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 ,9 addition to ! repres5tatives specifi$ 9 subp>agraph 7,a71 ! ,secret>y may1 ) ! agreem5t ( ! vacc9e develop] reque/+ a meet+ "u su* subp>agraph1 include 9 su* meet+ repres5tatives (-- 7i7 ! ,food & ,drug ,adm9i/ration2 & 7ii7 ! ,national ,vacc9e ,program4 7,c7 ,! ,secret>y %all conv5e a meet+ reque/$ ) a valid ju/ification "u subp>agraph 7,a7 n lat] ?an #abj 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$ or o!r demographically assess$ 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 comm]cial or f9ancial in=mation t is privileg$ or confid5tial & subject to section #eeb7;b77#d7 ( title #e1 ,unit$ ,/ates ,code1 or section #aije ( title #ah1 ,unit$ ,/ates ,code2 & 7v7 d n conta9 individually id5tifiable in=mation4 7,b7 ,! ,secret>y %all provide analyses reque/$ by a vacc9e manufactur] "u subp>agraph 7,a7 n lat] ?an #abj cal5d> days aft] receipt ( ! reque/ = ! analyses4 7#d7 ,! ,secret>y %all promptly notify a vacc9e develop] if-- 7,a7 ! ,secret>y becomes aw>e ( any significant *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 to su* in=mation may h implications = ! vacc9e develop]'s vacc9e rese>* & developm5t4 4 ,i ,orphan product ext5sions n[2 inc5tives = c]ta9 products = limit$ populations #baea4 ,ext5sion ( exclusivity p]iods = a drug approv$ = a new indication = a r>e disease or condition 7a7 ,9 g5]al ,*apt] ,v ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act1 z am5d$ by sections #bjfb & #bjfc1 is fur!r am5d$ by ins]t+ aft] section #eje;,h ( su* ,act ! foll[+3 #eje;,i4 ,ext5sion ( exclusivity p]iods = a drug approv$ = a new indication = a r>e disease or condition 7a7 ,designation 7#a7 ,9 g5]al ,! ,secret>y %all designate a drug z a drug approv$ = a new indication to prev5t1 diagnose1 or treat a r>e disease or condition = purposes ( grant+ ! ext5sions "u subsection 7b7 if-- 7,a7 prior to approval ( an application or supplem5tal application = ! new indication1 ! drug 0 approv$ or lic5s$ = m>ket+ "u section #eje7;c7 ( ?is ,act or section #cea7;a7 ( ! ,public ,heal? ,s]vice ,act b 0 n s approv$ or lic5s$ = ! new indication2 7,b7 7i7 ! sponsor ( ! approv$ or lic5s$ drug files an application or a supplem5tal application = approval ( ! new indication = use ( ! drug to prev5t1 diagnose1 or treat ! r>e disease or condition2 & 7ii7 ! ,secret>y approves ! application or supplem5tal application2 & 7,c7 ! application or supplem5tal application = ! new indication conta9s ! cons5t ( ! applicant to notice be+ giv5 by ! ,secret>y "u p>agraph 7#d7 respect+ ! designation ( ! drug4 7#b7 ,revocation ( designation 7,a7 ,9 g5]al ,except z provid$ 9 subp>agraph 7,b71 a designation "u p>agraph 7#a7 %all n be revok$ = any reason4 7,b7 ,exception ,! ,secret>y may revoke a designation ( a drug "u p>agraph 7#a7 if ! ,secret>y f9ds t ! application or supplem5tal application result+ 9 su* designation conta9$ an untrue /atem5t ( mat]ial fact4 7#c7 ,notification prior to discont9uance ( production = solely comm]cial reasons ,a designation ( a drug "u p>agraph 7#a7 %all be subject to ! condition t ! sponsor ( ! drug w notify ! ,secret>y ( any discont9uance ( ! production ( ! drug = solely comm]cial reasons at lea/ #a ye> be=e su* discont9uance4 7#d7 ,notice to public ,notice respect+ ! designation ( a drug "u p>agraph 7#a7 %all be made available to ! public4 7b7 ,ext5sion ,if ! ,secret>y designates a drug z a drug approv$ = a new indication = a r>e disease or condition1 z describ$ 9 subsection 7a77#a7-- 7#a7 7,a7 ! #d-1 #e-1 & #g-ye> p]iods describ$ 9 subsections 7c77#c77;,e77ii7 & 7j77#e77;,f77ii7 ( section #eje1 ! #c-ye> p]iods describ$ 9 clauses 7iii7 & 7iv7 ( subsection 7c77#c77;,e7 & clauses 7iii7 & 7iv7 ( subsection 7j77#e77;,f7 ( section #eje1 & ! #g-ye> p]iod describ$ 9 section #ebg1 z applicable1 %all be ext5d$ by #f mon?s2 or 7,b7 ! #d- & #ab-ye> p]iods describ$ 9 subp>agraphs 7,a7 & 7,b7 ( section #cea7k77#g7 ( ! ,public ,heal? ,s]vice ,act & ! #g-ye> p]iod describ$ 9 section #ebg1 z applicable1 %all be ext5d$ by #f mon?s2 & 7#b7 7,a7 if ! drug is ! subject ( a li/$ pat5t = :i* a c]tification has be5 submitt$ "u subsection 7b77#b77;,a77ii7 or 7j77#b77;,a77vii77,,ii7 ( section #eje or a li/$ pat5t = :i* a c]tification has be5 submitt$ "u subsections 7b77#b77;,a77iii7 or 7j77#b77;,a77vii77,,iii7 ( section #eje1 ! p]iod dur+ :i* an application may n be approv$ "u section #eje7;c77#c7 or section #eje7;j77#e77;,b7 %all be ext5d$ by a p]iod ( #f mon?s aft] ! date ! pat5t expires 7includ+ any pat5t ext5sions72 or 7,b7 if ! drug is ! subject ( a li/$ pat5t = :i* a c]tification has be5 submitt$ "u subsection 7b77#b77;,a77iv7 or 7j77#b77;,a77vii77,,iv7 ( section #eje1 & 9 ! pat5t infr+em5t litigation result+ f ! c]tification ! c\rt det]m9es t ! pat5t is valid & w\ld be infr+$1 ! p]iod dur+ :i* an application may n be approv$ "u section #eje7;c77#c7 or section #eje7;j77#e77;,b7 %all be ext5d$ by a p]iod ( #f mon?s aft] ! date ! pat5t expires 7includ+ any pat5t ext5sions74 7c7 ,relation to p$iatric & qualifi$ infecti\s disease product exclusivity ,any ext5sion "u subsection 7b7 ( a p]iod %all be 9 addition to any ext5sion ( ! p]iods "u sections #eje;,a & #eje;,e ( ?is ,act & section #cea7m7 ( ! ,public ,heal? ,s]vice ,act1 z applicable1 ) respect to ! drug4 7d7 ,limitations ,! ext5sion describ$ 9 subsection 7b7 %all n apply if ! drug designat$ "u subsection 7a77#a7 has previ\sly receiv$ an ext5sion by op]ation ( subsection 7b74 7e7 ,def9ition ,9 ?is section1 ! t]m r>e disease or condition has ! mean+ giv5 to su* t]m 9 section #ebf7;a77#b74 4 7b7 ,application ,section #eje;,g ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act1 z add$ by subsection 7a71 applies only ) respect to a drug = :i* an application or supplem5tal application describ$ 9 subsection 7a77#a77;,b77i7 ( su* section #eje;,g is fir/ approv$ "u section #eje7;c7 ( su* ,act 7#ba ,u4,s4,c4 #cee7;c77 or section #cea7;a7 ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bfb7;a77 on or aft] ! date ( ! enactm5t ( ?is ,act4 7c7 ,con=m+ am5dm5ts 7#a7 ,relation to p$iatric exclusivity = drugs ,section #eje;,a ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cee;a7 is am5d$-- 7,a7 9 subsection 7b71 by add+ at ! end ! foll[+3 7#c7 ,relation to exclusivity = a drug approv$ = a new indication = a r>e disease or condition ,not)/&+ ! ref]5ces 9 p>agraph 7#a7 to ! l5g?s ( ! exclusivity p]iods aft] application ( p$iatric exclusivity1 ! #f-mon? ext5sions describ$ 9 p>agraph 7#a7 %all be 9 addition to any ext5sions "u section #eje;,g4 2 & 7,b7 9 subsection 7c71 by add+ at ! end ! foll[+3 7#c7 ,relation to exclusivity = a drug approv$ = a new indication = a r>e disease or condition ,not)/&+ ! ref]5ces 9 p>agraph 7#a7 to ! l5g?s ( ! exclusivity p]iods aft] application ( p$iatric exclusivity1 ! #f-mon? ext5sions describ$ 9 p>agraph 7#a7 %all be 9 addition to any ext5sions "u section #eje;,g4 4 7#b7 ,relation to exclusivity = new qualifi$ infecti\s disease products t are drugs ,subsection 7b7 ( section #eje;,e ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cee;f7 is am5d$-- 7,a7 by am5d+ ! subsection head+ to read z foll[s3 ,relation to p$iatric exclusivity & exclusivity = a drug approv$ = a new indication = a r>e disease or condition4--2 & 7,b7 by /rik+ any ext5sion ( ! p]iod "u section #eje;,a & ins]t+ any ext5sion ( ! p]iods "u sections #eje;,a & #eje;,g1 z applicable14 7#c7 ,relation to p$iatric exclusivity = biological products ,section #cea7m7 ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bfb7m77 is am5d$ by add+ at ! end ! foll[+3 7#e7 ,relation to exclusivity = a biological product approv$ = a new indication = a r>e disease or condition ,not)/&+ ! ref]5ces 9 p>agraphs 7#b77;,a71 7#b77;,b71 7#c77;,a71 & 7#c77;,b7 to ! l5g?s ( ! exclusivity p]iods aft] application ( p$iatric exclusivity1 ! #f-mon? ext5sions describ$ 9 su* p>agraphs %all be 9 addition to any ext5sions "u section #eje;,g4 4 #baeb4 ,reau?orization ( r>e p$iatric disease priority review v\*] inc5tive program 7a7 ,9 g5]al ,section #ebi ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;ff7 is am5d$-- 7#a7 9 subsection 7a7-- 7,a7 9 p>agraph 7#c71 by am5d+ subp>agraph 7,a7 to read z foll[s3 7,a7 ,! disease is a s]i\s or life-?reat5+ disease 9 :i* ! s]i\s or life-?reat5+ manife/ations prim>ily affect individuals ag$ f bir? to #ah ye>s1 includ+ age gr\ps (t5 call$ neonates1 infants1 *ildr51 & adolesc5ts4 2 & 7,b7 9 p>agraph 7#d7-- 7i7 9 subp>agraph 7,e71 by /rik+ & at ! end2 7ii7 9 subp>agraph 7,f71 by /rik+ ! p]iod at ! end & ins]t+ 2 &2 & 7iii7 by add+ at ! end ! foll[+3 7,g7 is = a drug or biological product = :i* a priority review v\*] has n be5 issu$ "u section #ebd 7relat+ to tropical disease products74 2 & 7#b7 9 subsection 7b71 by /rik+ p>agraph 7#e7 & ins]t+ ! foll[+3 7#e7 ,t]m9ation ( au?ority 7,a7 ,9 g5]al ,! ,secret>y may n aw>d any priority review v\*]s "u p>agraph 7#a7 aft] ,decemb] #ca1 #bjah4 7,b7 ,exception ,not)/&+ subp>agraph 7,a71 ! sponsor ( a drug t is designat$ "u subsection 7d7 z a drug = a r>e p$iatric disease & t is ! subject ( a r>e p$iatric disease product application t is submitt$ dur+ ! p]iod beg9n+ on ! date ( enactm5t ( ! #ba/ ,c5tury ,cures ,act & end+ ! date specifi$ 9 subp>agraph 7,a7 %all rema9 eligible to receive a priority review v\*] "u p>agraph 7#a7 irrespective ( :e!r ! r>e p$iatric disease product application ) respect to su* drug is approv$ aft] ! end ( su* p]iod4 4 7b7 ,,gao /udy & report 7#a7 ,/udy ,! ,comptroll] ,g5]al ( ! ,unit$ ,/ates %all conduct a /udy on ! effectiv5ess ( aw>d+ priority review v\*]s "u section #ebi ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;ff7 9 provid+ inc5tives = ! developm5t ( drugs t treat or prev5t r>e p$iatric diseases 7z def9$ 9 subsection 7a77#c7 ( su* section7 t w\ld n o!rwise h be5 develop$4 ,9 conduct+ su* /udy1 ! ,comptroll] ,g5]al %all exam9e ! foll[+3 7,a7 ,! indications = :i* ea* drug = :i* a priority review v\*] 0 aw>d$ "u su* section #ebi 0 approv$ "u section #eje ( su* ,act 7#ba ,u4,s4,c4 #cee7 or section #cea ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bfb74 7,b7 ,:e!r ! priority review v\*] impact$ a sponsor's decision to inve/ 9 develop+ a drug to treat or prev5t a r>e p$iatric disease4 7,c7 ,an analysis ( ! drugs t utiliz$ su* priority review v\*]s1 :i* %all include-- 7i7 ! indications = :i* su* drugs 7 approv$ "u section #eje ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cee7 or section #cea ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bfb72 7ii7 :e!r unmet m$ical ne$s 7 address$ ?r\gh ! approval ( su* drugs1 includ+1 = ea* su* drug-- 7,i7 if an alt]native !rapy 0 previ\sly available to treat ! indication2 & 7,,ii7 ! b5efit or advantage ! drug provid$ ov] ano!r available !rapy2 7iii7 ! numb] ( pati5ts pot5tially treat$ by su* drugs2 7iv7 ! value ( ! priority review v\*] if transf]r$2 & 7v7 ! l5g? ( "t betwe5 ! date on :i* a priority review v\*] 0 aw>d$ & ! date on :i* x 0 us$4 7,d7 ,) respect to ! priority review v\*] program "u section #ebi ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;ff7-- 7i7 ! res\rces us$ by1 & burd5 plac$ on1 ! ,food & ,drug ,adm9i/ration 9 implem5t+ su* program1 includ+ ! effect ( su* program on ! ,food & ,drug ,adm9i/ration's review ( drugs = :i* a priority review v\*] 0 n aw>d$ or us$2 7ii7 ! impact ( ! program on ! public heal? z a result ( ! exp$it$ review ( applications = drugs t treat or prev5t non-s]i\s indications t are g5]ally us$ by ! broad] public2 & 7iii7 alt]native approa*es to improv+ su* program s t ! program is appropriately t>get$ t[>d provid+ inc5tives = ! developm5t ( cl9ically important drugs t-- 7,i7 prev5t or treat r>e p$iatric diseases2 & 7,,ii7 w\ld likely n o!rwise h be5 develop$ to prev5t or treat su* diseases4 7#b7 ,report ,n lat] ?an ,decemb] #ca1 #bjag1 ! ,comptroll] ,g5]al ( ! ,unit$ ,/ates %all submit to ! ,committee on ,en]gy & ,comm]ce ( ! ,h\se ( ,repres5tatives & ! ,committee on ,heal?1 ,education1 ,labor1 & ,p5sions ( ! ,s5ate a report conta9+ ! results ( ! /udy ( conduct$ "u p>agraph 7#a74 ,j ,dome/ic ,manufactur+ & ,export ,effici5cies #bafa4 ,grants = /udy+ ! process ( cont9u\s drug manufactur+ 7a7 ,9 g5]al ,! ,commission] ( ,food & ,drugs may aw>d grants to in/itutions ( high] education & nonpr(it organizations = ! purpose ( /udy+ & recomm5d+ improvem5ts to ! process ( cont9u\s manufactur+ ( drugs & biological products & simil> innovative monitor+ & control te*niques4 7b7 ,def9itions ,9 ?is section3 7#a7 ,! t]m drug has ! mean+ giv5 to su* t]m 9 section #bja ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cba74 7#b7 ,! t]m biological product has ! mean+ giv5 to su* t]m 9 section #cea7;i7 ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bfb7;i774 7#c7 ,! t]m in/itution ( high] education has ! mean+ giv5 to su* t]m 9 section #aja ( ! ,high] ,education ,act ( #aife 7#bj ,u4,s4,c4 #ajja74 7c7 ,au?orization ( appropriations ,!re is au?oriz$ to be appropriat$ to c>ry out ?is section #e1jjj1jjj = ea* ( fiscal ye>s #bjaf ?r\gh #bjbj4 #bafb4 ,re-exportation among memb]s ( ! ,european ,economic ,area ,section #ajjc ( ! ,controll$ ,sub/ances ,import & ,export ,act 7#ba ,u4,s4,c4 #iec7 is am5d$-- 7#a7 9 subsection 7f7-- 7,a7 9 p>agraph 7#e7-- 7i7 by /rik+ 7#e7 & ins]t+ 7#e77;,a72 7ii7 by ins]t+ 1 except t ! controll$ sub/ance may be export$ f ! second c\ntry to ano!r c\ntry t is a memb] ( ! ,european ,economic ,area be=e ! p]iod at ! end2 & 7iii7 by add+ at ! end ! foll[+3 7,b7 ,subsequ5t to any re-exportation describ$ 9 subp>agraph 7,a71 a controll$ sub/ance may cont9ue to be export$ f any c\ntry t is a memb] ( ! ,european ,economic ,area to any o!r su* c\ntry1 provid$ t-- 7i7 ! conditions applicable ) respect to ! fir/ c\ntry "u p>agraphs 7#a71 7#b71 7#c71 7#d71 7#f71 & 7#g7 are met by ea* subsequ5t c\ntry f :i* ! controll$ sub/ance is export$ pursuant to ?is p>agraph2 & 7ii7 ! conditions applicable ) respect to ! second c\ntry "u su* p>agraphs are met by ea* subsequ5t c\ntry to :i* ! controll$ sub/ance is export$ pursuant to ?is p>agraph4 2 & 7,b7 9 p>agraph 7#f7-- 7i7 by /rik+ 7#f7 & ins]t+ 7#f77;,a72 & 7ii7 by add+ at ! end ! foll[+3 7,b7 ,9 ! case ( re-exportation among memb]s ( ! ,european ,economic ,area1 )9 #cj days aft] ea* re-exportation1 ! p]son :o export$ ! controll$ sub/ance f ! ,unit$ ,/ates deliv]s to ! ,attorney ,g5]al-- 7i7 docum5tation c]tify+ t su* re-exportation has occurr$2 & 7ii7 in=mation conc]n+ ! consignee1 c\ntry1 & product4 2 & 7#b7 by add+ at ! end ! foll[+3 7g7 ,limitation ,subject to p>agraphs 7#e7 & 7#f7 ( subsection 7f7 9 ! case ( any controll$ sub/ance 9 s*$ule ,i or ,,ii or any n>cotic drug 9 s*$ule ,,iii or ,,iv1 ! ,attorney ,g5]al %all n promulgate nor en=ce any regulation1 subregulatory guidance1 or en=cem5t policy :i* imp$es re-exportation ( any controll$ sub/ance among ,european ,economic ,area c\ntries1 includ+ by promulgat+ or en=c+ any requirem5t t-- 7#a7 re-exportation f ! fir/ c\ntry to ! second c\ntry or re-exportation f ! second c\ntry to ano!r c\ntry occur )9 a specifi$ p]iod ( "t2 or 7#b7 in=mation conc]n+ ! consignee1 c\ntry1 & product be provid$ prior to exportation ( ! controll$ sub/ance f ! ,unit$ ,/ates or prior to ea* re-exportation among memb]s ( ! ,european ,economic ,area4 4 ,k ,enhanc+ comb9ation products review #baha4 ,enhanc+ comb9ation products review ,section #ejc7;g77#d77;,c7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cec7;g77#d77;,c77 is am5d$ by add+ at ! end ! foll[+ new clause3 7iii7 ,n lat] ?an #ah mon?s aft] ! date ( ! enactm5t ( ! #ba/ ,c5tury ,cures ,act1 ! ,secret>y %all issue f9al guidance t describes ! responsibilities ( ea* ag5cy c5t] reg>d+ its review ( comb9ation products4 ,! ,secret>y %all1 aft] solicit+ public comm5t1 review & update ! guidance p]iodically4 4 ,l ,priority ,review = ,break?r\gh ,devices #bbja4 ,priority review = break?r\gh devices 7a7 ,9 g5]al ,*apt] ,v ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act is am5d$-- 7#a7 9 section #eae7;d7-- 7,a7 by /rik+ p>agraph 7#e72 & 7,b7 by r$esignat+ p>agraph 7#f7 z p>agraph 7#e72 & 7#b7 by ins]t+ aft] section #eae;,a 7#ba ,u4,s4,c4 #cfj;e-#a7 ! foll[+3 #eae;,b4 ,priority review = break?r\gh devices 7a7 ,9 g5]al ,9 ord] to provide = m effective treatm5t or diagnosis ( life-?reat5+ or irrev]sibly debilitat+ human diseases or conditions1 ! ,secret>y %all e/abli% a program to provide priority review = devices-- 7#a7 repres5t+ break?r\gh te*nologies2 7#b7 = :i* no approv$ alt]natives exi/2 7#c7 (f]+ significant advantages ov] exi/+ approv$ or cle>$ alt]natives1 includ+ ! pot5tial to1 comp>$ to exi/+ approv$ or cle>$ alt]natives1 r$uce or elim9ate ! ne$ = hospitalization1 improve pati5t quality ( life1 facilitate pati5ts' ability to manage _! own c>e 7su* z ?r\gh self-direct$ p]sonal assi/ance71 or e/abli% long-t]m cl9ical effici5cies2 or 7#d7 ! availability ( :i* is 9 ! be/ int]e/ ( pati5ts4 7b7 ,reque/ = designation ,a sponsor ( a device may reque/ t ! ,secret>y designate ! device = priority review "u ?is section4 ,any su* reque/ = designation may be made at any "t prior to ! submission ( an application "u section #eae7;c71 a petition = classification "u section #eac7;f77#b71 or a notification "u section #eaj7k74 7c7 ,designation process 7#a7 ,9 g5]al ,n lat] ?an #fj cal5d> days aft] ! receipt ( a reque/ "u subsection 7b71 ! ,secret>y %all det]m9e :e!r ! device t is ! subject ( ! reque/ meets ! crit]ia describ$ 9 subsection 7a74 ,if ! ,secret>y det]m9es t ! device meets ! crit]ia1 ! ,secret>y %all designate ! device = priority review4 7#b7 ,review ,review ( a reque/ "u subsection 7b7 %all be und]tak5 by a team t is compos$ ( exp]i5c$ /aff & manag]s ( ! ,food & ,drug ,adm9i/ration & is *air$ by a s5ior manag]4 7#c7 ,designation det]m9ation ,a det]m9ation approv+ or d5y+ a reque/ "u subsection 7b7 %all be consid]$ a significant decision "u section #eag;,a & ! ,secret>y %all provide a writt51 sub/antive summ>y ( ! basis = ! det]m9ation 9 accordance ) section #eag;,a7a74 7#d7 ,reconsid]ation 7,a7 ,reque/ = reconsid]ation ,any p]son ^: reque/ "u subsection 7b7 is d5i$ may1 )9 #cj days ( ! d5ial1 reque/ reconsid]ation ( ! d5ial 9 accordance ) section #eag;,a7b7-- 7i7 bas$ ^u ! submission ( docum5ts by su* p]son2 or 7ii7 bas$ ^u su* docum5ts & a meet+ or teleconf]5ce4 7,b7 ,response ,reconsid]ation ( a designation det]m9ation "u ?is p>agraph %all be conduct$ 9 accordance ) section #eag;,a7b74 7#e7 ,)drawal ,if ! ,secret>y approves a priority review designation = a device "u ?is section1 ! ,secret>y may n )draw ! designation bas$ on ! fact t ! crit]ia specifi$ 9 subsection 7a7 are no long] met because ( ! subsequ5t cle>ance or approval ( ano!r device t 0 designat$ "u-- 7,a7 ?is section2 or 7,b7 section #eae7;d77#e7 7z 9 effect imm$iately prior to ! enactm5t ( ! #ba/ ,c5tury ,cures ,act74 7d7 ,priority review 7#a7 ,actions ,= purposes ( exp$it+ ! developm5t & review ( devices designat$ "u subsection 7c71 ! ,secret>y %all-- 7,a7 assign a team ( /aff1 includ+ a team lead] ) appropriate subject matt] exp]tise & exp]i5ce1 = ea* device = :i* a reque/ is submitt$ "u subsection 7b72 7,b7 provide = ov]sight ( ! team by s5ior ag5cy p]sonnel to facilitate ! effici5t developm5t ( ! device & ! effici5t review ( any submission describ$ 9 subsection 7b7 = ! device2 7,c7 adopt an effici5t process = timely dispute resolution2 7,d7 provide = int]active communication ) ! sponsor ( ! device dur+ ! review process2 7,e7 exp$ite ! ,secret>y's review ( manufactur+ & quality sy/ems compliance1 z applicable2 7,f7 disclose to ! sponsor 9 advance ! topics ( any consultation conc]n+ ! sponsor's device t ! ,secret>y int5ds to und]take ) ext]nal exp]ts or an advisory committee & provide ! sponsor an opportunity to recomm5d su* ext]nal exp]ts2 7,g7 = applications submitt$ "u section #eae7;c71 provide = advisory committee input1 z ! ,secret>y det]m9es appropriate 7includ+ 9 response to ! reque/ ( ! sponsor72 & 7,h7 assign /aff to be available )9 a reasonable "t to address que/ions pos$ by in/itutional review committees conc]n+ ! conditions & cl9ical te/+ requirem5ts applicable to ! inve/igational use ( ! device pursuant to an exemption "u section #ebj7;g74 7#b7 ,additional actions ,9 addition to ! actions describ$ 9 p>agraph 7#a71 = purposes ( exp$it+ ! developm5t & review ( devices designat$ "u subsection 7c71 ! ,secret>y1 9 collaboration ) ! device sponsor1 may1 z appropriate-- 7,a7 coord9ate ) ! sponsor reg>d+ e>ly agreem5t on a data developm5t plan2 7,b7 take /eps to ensure t ! design ( cl9ical trials is z effici5t z practicable1 su* z ?r\gh adoption ( %ort] or small] cl9ical trials1 application ( surrogate endpo9ts1 & use ( adaptive trial designs & ,bayesian /ati/ics1 to ! ext5t sci5tifically appropriate2 7,c7 facilitate1 to ! ext5t sci5tifically appropriate1 exp$it$ & effici5t developm5t & review ( ! device ?r\gh utilization ( timely po/m>ket data collection1 ) reg>d to applications = approval "u section #eae7;c72 & 7,d7 agree to cl9ical protocols t ! ,secret>y w consid] b9d+ on ! ,secret>y & ! sponsor1 subject to-- 7i7 *anges agre$ to by ! sponsor & ! ,secret>y2 7ii7 *anges t ! ,secret>y det]m9es are requir$ to prev5t an unreasonable risk to ! public heal?2 or 7iii7 ! id5tification ( a sub/antial sci5tific issue det]m9$ by ! ,secret>y to be ess5tial to ! safety or effectiv5ess ( ! device involv$4 7e7 ,priority review guidance 7#a7 ,cont5t ,! ,secret>y %all issue guidance on ! implem5tation ( ?is section4 ,su* guidance %all include ! foll[+3 7,a7 ,! process = a p]son to seek a priority review designation4 7,b7 ,a template = reque/s "u subsection 7b74 7,c7 ,! crit]ia ! ,secret>y w use 9 evaluat+ a reque/ = priority review4 7,d7 ,! /&>ds ! ,secret>y w use 9 assign+ a team ( /aff1 includ+ team lead]s1 to review devices designat$ = priority review1 includ+ any tra9+ requir$ = su* p]sonnel on effective & effici5t review4 7#b7 ,process ,prior to f9aliz+ ! guidance "u p>agraph 7#a71 ! ,secret>y %all propose su* guidance = public comm5t4 7f7 ,con/ruction 7#a7 ,purpose ,?is section is int5d$ to enc\rage ! ,secret>y & provide ! ,secret>y suffici5t au?orities to apply effici5t & flexible approa*es to exp$ite ! developm5t (1 & prioritize ! ag5cy's review (1 devices t repres5t break?r\gh te*nologies4 7#b7 ,con/ruction ,no?+ 9 ?is section %all be con/ru$ to alt] ! crit]ia & /&>ds = evaluat+ an application pursuant to section #eae7;c71 a report & reque/ = classification "u section #eac7;f77#b71 or a report "u section #eaj7k71 includ+ ! recognition ( valid sci5tific evid5ce z describ$ 9 section #eac7;a77#c77;,b71 & consid]ation ( ! lea/ burd5some means ( evaluat+ device effectiv5ess or demon/rat+ sub/antial equival5ce betwe5 devices ) diff]+ te*nological *>act]i/ics1 z applicable4 ,no?+ 9 ?is section alt]s ! au?ority ( ! ,secret>y to act on an application pursuant to section #eae7;d7 be=e completion ( an e/abli%m5t inspection1 z ! ,secret>y deems appropriate4 4 7b7 ,con=m+ am5dm5t relat$ to designation det]m9ations ,section #eag;,a7a77#a7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;g-#a7;a77#a77 is am5d$ by ins]t+ a reque/ = designation "u section #eae;,b1 aft] an application "u section #eae14 ,m ,m$ical ,device ,regulatory ,process ,improvem5ts #bbba4 ,?ird-p>ty quality sy/em assessm5t 7a7 ,e/abli%m5t ( ?ird-,p>ty quality sy/em assessm5t program ,*apt] ,v ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act is am5d$ by ins]t+ aft] section #ebd;,a 7#ba ,u4,s4,c4 #cfjn-#a7 ! foll[+ new section3 #ebd;,b4 ,?ird-p>ty quality sy/em assessm5t 7a7 ,accr$itation & assessm5t 7#a7 ,9 g5]al2 c]tification ( device quality sy/em ,! ,secret>y %all1 9 accordance ) ?is section1 e/abli% a ?ird-p>ty quality sy/em assessm5t program-- 7,a7 to accr$it p]sons to assess :e!r a reque/or's quality sy/em1 includ+ its design controls1 c reasonably assure ! safety & effectiv5ess ( 9-scope devices subject to device-relat$ *anges2 7,b7 "u :i* accr$it$ p]sons %all 7z applicable7 c]tify t a reque/or's quality sy/em meets ! crit]ia includ$ 9 ! guidance issu$ "u p>agraph 7#e7 ) respect to ! 9-scope devices at issue2 & 7,c7 "u :i* ! ,secret>y %all rely on su* c]tifications = purposes ( det]m9+ ! safety & effectiv5ess 7or z applicable1 sub/antial equival5ce7 ( 9-scope devices subject to ! device-relat$ *anges involv$1 9 lieu ( compliance ) ! foll[+ submission requirem5ts3 7i7 ,a prem>ket notification4 7ii7 ,a #cj-;day notice4 7iii7 ,a ,special ,,pma supplem5t4 7#b7 ,def9itions ,= purposes ( ?is section 7,a7 ! t]m device-relat$ *anges means *anges made by a reque/or ) respect to 9-scope devices1 :i* are-- 7i7 *anges to a device f\nd to be sub/antially equival5t "u sections #eac7;i7 & #eaj7k7 to a pr$icate device1 t-- 7,i7 w\ld o!rwise be subject to a prem>ket notification2 & 7,,ii7 d n alt]-- 7aa7 ! int5d$ use ( ! *ang$ device2 or 7bb7 ! fundam5tal sci5tific te*nology ( su* device2 7ii7 manufactur+ *anges subject to a #cj-;day notice2 7iii7 *anges t qualify = a ,special ,,pma ,supplem5t2 & 7iv7 su* o!r *anges relat+ to ! devices or ! device manufactur+ process z ! ,secret>y det]m9es appropriate2 7,b7 ! t]m 9-scope device means a device )9 ! scope ( devices agre$ to by ! reque/or & ! accr$it$ p]son = purposes ( a reque/ = c]tification "u ?is section2 7,c7 ! t]m prem>ket notification means a prem>ket notification "u section #eaj7k72 7,d7 ! t]m quality sy/em means ! me?ods us$ 91 & ! facilities & controls us$ =1 ! design1 manufacture1 packag+1 label+1 /orage1 in/allation1 & s]vic+ ( devices1 z describ$ 9 section #ebj7;f72 7,e7 ! t]m reque/or means a device manufactur] t is seek+ c]tification "u ?is section ( a quality sy/em us$ by su* manufactur]2 7,f7 ! t]m ,special ,,pma means a ,special ,,pma supplem5t "u section #had4ci7;d7 ( title #ba1 ,code ( ,f$]al ,regulations 7or any successor regulations72 & 7,g7 ! t]m #cj-;day notice means a notice describ$ 9 section #eae7;d77#f74 7#c7 ,accr$itation process2 accr$itation r5ewal ,except z inconsi/5t ) ?is section1 ! process & qualifications = accr$itation ( p]sons & r5ewal ( su* accr$itation "u section #gjd7;g7 %all apply ) respect to accr$itation ( p]sons & r5ewal ( su* accr$itation "u ?is section4 7#d7 ,use ( accr$it$ p>ties to conduct assessm5ts 7,a7 ,initiation ( assessm5t s]vices 7i7 ,date assessm5ts au?oriz$ ,beg9n+ aft] ! date on :i* ! f9al guidance is issu$ "u p>agraph 7#e71 an accr$it$ p]son may conduct an assessm5t "u ?is section4 7ii7 ,initiation ( assessm5ts ,use ( "o or m accr$it$ p]sons to assess a reque/or's quality sy/em "u ?is section ) respect to 9-scope devices %all be at ! initiation ( ! p]son :o regi/]s & li/s ! devices at issue "u section #eaj4 7,b7 ,comp5sation ,comp5sation = su* accr$it$ p]sons %all-- 7i7 be det]m9$ by agreem5t betwe5 ! accr$it$ p]son & ! p]son :o engages ! s]vices ( ! accr$it$ p]son2 & 7ii7 be paid by ! p]son :o engages su* s]vices4 7,c7 ,accr$it$ p]son selection ,ea* p]son :o *ooses to use an accr$it$ p]son to assess a reque/or's quality sy/em1 z describ$ 9 ?is section1 %all select ! accr$it$ p]son f a li/ ( su* p]sons publi%$ by ! ,secret>y 9 accordance ) section #gjd7;g77#d74 7#e7 ,guidance2 crit]ia = c]tification 7,a7 ,9 g5]al ,! crit]ia = c]tification ( a quality sy/em "u ?is section %all be z specifi$ by ! ,secret>y 9 guidance issu$ "u ?is p>agraph4 7,b7 ,cont5ts2 crit]ia ,! guidance "u ?is p>agraph %all include specification (-- 7i7 evaluative crit]ia to be us$ by an accr$it$ p]son to assess &1 z applicable1 c]tify a reque/or's quality sy/em "u ?is section ) respect to 9-scope devices2 & 7ii7 crit]ia = accr$it$ p]sons to apply = a waiv] (1 & exemptions f1 ! crit]ia "u clause 7i74 7,c7 ,timeframe = issu+ guidance ,! ,secret>y %all issue "u ?is p>agraph-- 7i7 draft guidance n lat] ?an #ab mon?s aft] ! enactm5t ( ! #ba/ ,c5tury ,cures ,act2 & 7ii7 f9al guidance n lat] ?an #ab mon?s aft] issuance ( ! draft guidance "u clause 7i74 7b7 ,use ( ?ird-,p>ty assessm5t 7#a7 ,assessm5t summ>y2 c]tification 7,a7 ,submission ( assessm5t to secret>y ,an accr$it$ p]son :o assesses a reque/or's quality sy/em "u subsection 7a7 %all submit to ! ,secret>y a summ>y ( ! assessm5t-- 7i7 )9 #cj days ( ! assessm5t2 & 7ii7 :i* %all include 7z applicable7-- 7,i7 ! accr$it$ p]son's c]tification t ! reque/or has satisfi$ ! crit]ia specifi$ 9 ! guidance issu$ "u subsection 7a77#e7 = quality sy/em c]tification ) respect to ! 9-scope devices at issue2 & 7,,ii7 any waiv]s or exemptions f su* crit]ia appli$ by ! accr$it$ p]son4 7,b7 ,treatm5t ( assessm5ts ,subject to action by ! ,secret>y "u subp>agraph 7,c71 ) respect to assessm5ts :i* include a c]tification "u ?is section-- 7i7 ! ,secret>y's review ( ! assessm5t summ>y %all be deem$ complete on ! day t is #cj days aft] ! date on :i* ! ,secret>y receives ! summ>y "u subp>agraph 7,a72 & 7ii7 ! assessm5t summ>y & c]tification ( ! quality sy/em ( a reque/or %all be deem$ accept$ by ! ,secret>y on su* #cj? day4 7,c7 ,actions by secret>y 7i7 ,9 g5]al ,)9 #cj days ( receiv+ an assessm5t summ>y & c]tification "u subp>agraph 7,a71 ! ,secret>y may1 by writt5 notice to ! accr$it$ p]son submitt+ su* assessm5t c]tification1 deem any su* c]tification to be provisional beyond su* #cj-;day p]iod1 susp5d$ p5d+ fur!r review by ! ,secret>y1 or o!rwise qualifi$ or cancell$1 bas$ on ! ,secret>y's det]m9ation t 7z applicable7-- 7,i7 additional in=mation is ne$$ to support su* c]tification2 7,,ii7 su* assessm5t or c]tification is unw>rant$2 or 7,,iii7 su* action ) reg>d to ! c]tification is o!rwise ju/ifi$ accord+ to su* factors & crit]ia z ! ,secret>y f9ds appropriate4 7ii7 ,acceptance ( c]tification ,if foll[+ action by ! ,secret>y "u clause 7i7 ) respect to a c]tification1 ! ,secret>y det]m9es t su* c]tification is acceptable1 ! ,secret>y %all issue writt5 notice to ! applicable accr$it$ p]son indicat+ su* acceptance4 7#b7 ,notifications to ,secret>y by c]tifi$ reque/ors or accr$it$ p]sons = program evaluation purposes 7,a7 ,annual summ>y report = device-relat$ *anges o!rwise subject to prem>ket notification ,a reque/or ^: quality sy/em is c]tifi$ "u ?is section t effectuates device-relat$ *anges ) respect to 9-scope devices1 )\t prior submission ( a prem>ket notification1 %all ensure t an annual summ>y report is submitt$ to ! ,secret>y by ! accr$it$ p]son :i*-- 7i7 describes ! *anges made to ! 9-scope device2 & 7ii7 indicates ! effective dates ( su* *anges4 7,b7 ,p]iodic notification = manufactur+ *anges o!rwise subject to #cj-;day notice ,a reque/or ^: quality sy/em is c]tifi$ "u ?is section t effectuates device-relat$ *anges ) respect to 9-scope devices1 )\t prior submission ( a #cj-;day notice1 %all provide notification to ! ,secret>y ( su* *anges 9 ! reque/or's next p]iodic report "u section #had4hd7;b7 ( title #ba1 ,code ( ,f$]al ,regulations 7or any successor regulation74 ,su* notification %all-- 7i7 describe ! *anges made2 & 7ii7 indicate ! effective dates ( su* *anges4 7,c7 ,p]iodic notification = device-relat$ *anges o!rwise subject to special pma supplem5t ,a reque/or ^: quality sy/em is c]tifi$ "u ?is section t effectuates device-relat$ *anges ) respect to 9-scope devices1 )\t prior submission ( a ,special ,,pma ,supplem5t1 %all provide notification to ! ,secret>y ( su* *anges 9 ! reque/or's next p]iodic report "u section #had4hd7;b7 ( title #ba1 ,code ( ,f$]al ,regulations 7or any successor regulation74 ,su* notification %all-- 7i7 describe ! *anges made1 includ+ a full explanation ( ! basis = ! *anges2 & 7ii7 indicate ! effective dates ( su* *anges4 7,d7 ,use ( notifications = program evaluation purposes ,in=mation submitt$ to ! ,secret>y "u subp>agraphs 7,a7 ?r\gh 7,c7 %all be us$ by ! ,secret>y = purposes ( ! program evaluation "u subsection 7d74 7c7 ,duration & effect ( c]tification ,a c]tification "u ?is section-- 7#a7 %all rema9 9 effect = a p]iod ( #b ye>s f ! date su* c]tification is accept$ by ! ,secret>y1 subject to p>agraph 7#f72 7#b7 may be r5ew$ ?r\gh ! process describ$ 9 subsection 7a77#c72 7#c7 %all cont9ue to apply ) respect to device-relat$ *anges made dur+ su* #b-ye> p]iod1 provid$ ! c]tification rema9s 9 effect1 irrespective ( :e!r su* c]tification is r5ew$ aft] su* #b-ye> p]iod2 7#d7 %all h no effect on ! ne$ to comply ) applicable submission requirem5ts specifi$ 9 subsection 7a77#a77;,c7 ) respect to any *ange p]ta9+ to 9-scope devices :i* is n a device-relat$ *ange "u subsection 7a77#b72 7#e7 %all h no effect on ! au?ority ( ! ,secret>y to conduct an inspection or o!rwise det]m9e :e!r ! reque/or has compli$ ) ! applicable requirem5ts ( ?is ,act2 & 7#f7 may be revok$ by ! ,secret>y ^u a det]m9ation t ! reque/or's quality sy/em no long] meets ! crit]ia specifi$ 9 ! guidance issu$ "u subsection 7a77#e7 ) respect to ! 9-scope devices at issue4 7d7 ,notice ( revocation ,! ,secret>y %all provide writt5 notification to ! reque/or ( a revocation pursuant to subsection 7c77#f7 n lat] ?an #aj bus9ess days aft] ! det]m9ation describ$ 9 su* subsection4 ,^u receipt ( ! writt5 notification1 ! reque/or %all satisfy ! applicable submission requirem5ts specifi$ 9 subsection 7a77#a77;,c7 = any device-relat$ *anges effectuat$ aft] ! date ( su* det]m9ation4 ,aft] su* revocation1 su* reque/or is eligible to seek re-c]tification "u ?is section ( its quality sy/em4 7e7 ,program evaluation2 sunset 7#a7 ,program evaluation & report 7,a7 ,evaluation ,! ,secret>y %all complete an evaluation ( ! ?ird-p>ty quality sy/em assessm5t program "u ?is section no lat] ?an ,janu>y #ca1 #bjba1 bas$ on-- 7i7 analysis ( in=mation f a repres5tative gr\p ( device manufactur]s obta9$ f notifications provid$ by c]tifi$ reque/ors or accr$it$ p]sons "u subsection 7b77#b72 & 7ii7 su* o!r available in=mation & data z ! ,secret>y det]m9es appropriate4 7,b7 ,report ,no lat] ?an #a ye> aft] complet+ ! evaluation "u subp>agraph 7,a71 ! ,secret>y %all issue a report ( ! evaluation's f9d+s on ! website ( ! ,food & ,drug ,adm9i/ration1 :i* %all include ! ,secret>y's recomm5dations ) respect to cont9uation & z applicable expansion ( ! program "u ?is section to encompass-- 7i7 device submissions beyond ^? id5tifi$ 9 subsection 7a77#a77;,c72 & 7ii7 device *anges beyond ^? describ$ 9 subsection 7a77#b77;,a74 7#b7 ,sunset ,?is section %all cease to be effective ,octob] #a1 #bjbb4 7f7 ,rule ( con/ruction ,no?+ 9 ?is section %all be con/ru$ to limit ! au?ority ( ! ,secret>y to reque/ & review ! complete assessm5t ( a c]tifi$ reque/or "u ?is section on a =-cause basis4 4 7b7 ,con=m+ am5dm5ts 7#a7 ,requirem5ts = prem>ket approval supplem5ts ,section #eae7;d77#e77;,a77i7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;e7d77#e77;,a77i771 z r$esignat$ by section #bbja1 is fur!r am5d$ by ins]t+ 1 subject to section #ebd;,b aft] t affects safety or effectiv5ess4 7#b7 ,requirem5ts = #cj-;day notice ,section #eae7;d77#e77;,a77ii7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;e7d77#e77;,a77ii771 z r$esignat$ by section #bbja1 is fur!r am5d$ by ins]t+ 1 subject to section #ebd;,b aft] ! date on :i* ! ,secret>y receives ! notice4 7#c7 ,requirem5ts = prem>ket notification2 te*nical correction to ref]5ce to section #eaj7k7 ,section #eaj7l7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj7l77 is am5d$ by /rik+ ( ?is subsection "u subsection 7m7 & ins]t+ ( subsection 7k7 "u subsection 7m7 or section #ebd;,b4 7#d7 ,misbr&$ devices ,section #ejb7t7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #ceb7t77 is am5d$ by ins]t+ or #ebd;,b aft] section #eai4 #bbbb4 ,valid sci5tific evid5ce ,section #eac7;a77#c77;,b7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;c7a77#c77;,b77 is am5d$-- 7#a7 by r$esignat+ clauses 7i7 & 7ii7 z subclauses 7,i7 & 7,,ii71 respectively2 7#b7 by /rik+ 7,b7 ,if ! ,secret>y & ins]t+ 7,b77i7 ,if ! ,secret>y2 & 7#c7 by add+ at ! end ! foll[+3 7ii7 ,= purposes ( clause 7i71 valid sci5tific evid5ce may include-- 7,i7 evid5ce describ$ 9 well-docum5t$ case hi/ories1 includ+ regi/ry data1 t are collect$ & monitor$ "u a protocol det]m9$ to be acceptable by ! ,secret>y2 7,,ii7 /udies publi%$ 9 pe]-review$ j\rnals2 & 7,,iii7 data collect$ 9 c\ntries o!r ?an ! ,unit$ ,/ates s long z su* data o!rwise meet ! crit]ia specifi$ 9 ?is subp>agraph4 7iii7 ,9 ! case ( a /udy publi%$ 9 a pe]-review$ j\rnal t is (f]$ z valid sci5tific evid5ce = purposes ( clause 7i71 ! ,secret>y may reque/ data und]ly+ ! /udy if-- 7,i7 ! ,secret>y1 9 mak+ su* reque/1 complies ) ! requirem5t ( subp>agraph 7,d77ii7 to consid] ! lea/ burd5some appropriate means ( evaluat+ device effectiv5ess or subsection 7i77#a77;,d7 to consid] ! lea/ burd5some means ( det]m9+ sub/antial equival5ce1 z applicable2 7,,ii7 ! ,secret>y furni%es a writt5 rationale = s reque/+ ! und]ly+ data toge!r ) su* reque/2 & 7,,iii7 if ! reque/$ und]ly+ data = su* a /udy are unavailable1 ! ,secret>y %all consid] su* /udy to be "p ( ! totality ( ! evid5ce ) respect to ! device1 z ! ,secret>y det]m9es appropriate4 4 #bbbc4 ,tra9+ & ov]sight 9 lea/ burd5some appropriate means concept 7a7 ,9 g5]al ,section #eac ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;c7 is am5d$ by add+ at ! end ! foll[+3 7j7 ,tra9+ & ov]sight 9 lea/ burd5some appropriate means concept 7#a7 ,tra9+ ,ea* employee ( ! ,food & ,drug ,adm9i/ration :o is involv$ 9 ! review ( prem>ket submissions "u section #eae or section #eaj7k71 includ+ sup]visors1 %all receive tra9+ reg>d+ ! mean+ & implem5tation ( ! lea/ burd5some appropriate means concept 9 ! context ( ! use ( t t]m 9 subsections 7a77#c77;,d7 & 7i77#a77;,d7 ( ?is section & 9 section #eae7;c77#e74 7#b7 ,guidance docum5ts 7,a7 ,draft updat$ guidance ,n lat] ?an #ab mon?s aft] ! date ( enactm5t ( ! #ba/ ,c5tury ,cures ,act1 ! ,secret>y %all issue a draft guidance docum5t updat+ ! ,octob] #d1 #bjjb1 guidance docum5t entitl$ ,! ,lea/ ,burd5some ,provision ( ! ,,fda ,mod]nization ,act ( #aiig3 ,concept & ,pr9ciples2 ,f9al ,guidance = ,,fda & ,indu/ry4 7,b7 ,meet+ ( /akehold]s ,9 develop+ su* draft guidance docum5t1 ! ,secret>y %all conv5e a meet+ ( /akehold]s to ensure a full record to support ! publication ( su* docum5t4 7#c7 ,ombudsman audit ,n lat] ?an #ah mon?s aft] ! date ( issuance ( f9al v]sion ( ! draft guidance "u p>agraph 7#b71 ! ombudsman = ! organizational unit ( ! ,food & ,drug ,adm9i/ration responsible = ! prem>ket review ( devices %all-- 7,a7 conduct1 or h conduct$1 an audit ( ! tra9+ describ$ 9 p>agraph 7#a72 & 7,b7 include 9 su* audit int]views ) a repres5tative sample ( p]sons f indu/ry reg>d+ _! exp]i5ce 9 ! device prem>ket review process4 4 7b7 ,additional in=mation reg>d+ prem>ket applications ,subsection 7c7 ( section #eae ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;e7 is am5d$ by add+ at ! end ! foll[+3 7#e7 7,a7 ,:5ev] ! ,secret>y reque/s additional in=mation f an applicant reg>d+ an application "u p>agraph 7#a71 ! ,secret>y %all consid] ! lea/ burd5some appropriate means necess>y to demon/rate device safety & effectiv5ess1 & reque/ in=mation accord+ly4 7,b7 ,= purposes ( subp>agraph 7,a71 ! t]m necess>y means ! m9imum requir$ in=mation t w\ld support a det]m9ation by ! ,secret>y t an application provides a reasonable assurance ( ! safety & effectiv5ess ( ! device4 7,c7 ,no?+ 9 ?is p>agraph alt]s ! /&>ds = prem>ket approval ( a device4 4 #bbbd4 ,recognition ( /&>ds ,section #ead7;c7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;d7c77 is am5d$-- 7#a7 9 p>agraph 7#a71 by ins]t+ aft] subp>agraph 7,b7 ! foll[+ new subp>agraphs3 7,c7 7i7 ,any p]son may submit a reque/ = recognition "u subp>agraph 7,a7 ( all or "p ( an appropriate /&>d e/abli%$ by a nationally or int]nationally recogniz$ /&>d organization4 7ii7 ,n lat] ?an #fj days aft] ! ,secret>y receives su* a reque/1 ! ,secret>y %all-- 7,i7 make a det]m9ation to recognize all1 "p1 or none ( ! /&>d t is ! subject ( ! reque/2 & 7,,ii7 issue to ! p]son :o submitt$ su* reque/ a response 9 writ+ t /ates ! ,secret>y's rationale = t det]m9ation1 includ+ ! sci5tific1 te*nical1 regulatory1 or o!r basis = su* det]m9ation4 7iii7 ,! ,secret>y %all make a response issu$ "u clause 7ii77,,ii7 publicly available1 9 su* mann] z ! ,secret>y det]m9es appropriate4 7iv7 ,! ,secret>y %all take su* actions z may be necess>y to implem5t all or "p ( a /&>d recogniz$ "u clause 7i77,i71 9 accordance ) subp>agraph 7,a74 7,d7 ,! ,secret>y %all make publicly available1 9 su* mann] z ! ,secret>y det]m9es appropriate1 ! rationale = recognition "u subp>agraph 7,a7 ( "p ( a /&>d1 includ+ ! sci5tific1 te*nical1 regulatory1 or o!r basis = su* recognition4 2 & 7#b7 by add+ at ! end ! foll[+ new p>agraphs3 7#d7 ,tra9+ on use ( /&>ds ,! ,secret>y %all provide to all employees ( ! ,food & ,drug ,adm9i/ration :o review prem>ket submissions = devices p]iodic tra9+ on ! concept & use ( recogniz$ /&>ds = purposes ( meet+ a prem>ket submission requirem5t or o!r applicable requirem5t "u ?is ,act1 includ+ /&>ds relevant to an employee's area ( device review4 7#e7 ,guidance 7,a7 ,draft guidance ,! ,secret>y %all publi% guidance id5tify+ ! pr9ciples = recogniz+ /&>ds "u ?is section4 ,9 publi%+ su* guidance1 ! ,secret>y %all consid]-- 7i7 ! exp]i5ce )1 & reliance on1 a /&>d by o!r ,f$]al regulatory au?orities & ! device indu/ry2 & 7ii7 :e!r recognition ( a /&>d w promote h>monization among regulatory au?orities 9 ! regulation ( devices4 7,b7 ,tim+ ,! ,secret>y %all publi%-- 7i7 draft guidance "u subp>agraph 7,a7 n lat] ?an #ab mon?s aft] ! date ( ! enactm5t ( ! #ba/ ,c5tury ,cures ,act2 & 7ii7 f9al guidance n lat] ?an #ab mon?s aft] ! close ( ! public comm5t p]iod = ! draft guidance "u clause 7i74 4 #bbbe4 ,eas+ regulatory burd5 ) respect to c]ta9 class ,i & class ,,ii devices 7a7 ,class ,i devices ,section #eaj7l7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj7l77 is am5d$-- 7#a7 by /rik+ ,a report "u subsection 7k7 & ins]t+ 7#a7 ,a report "u subsection 7k72 & 7#b7 by add+ at ! end ! foll[+ new p>agraph3 7#b7 ,n lat] ?an #abj days aft] ! date ( ! enactm5t ( ! #ba/ ,c5tury ,cures ,act1 ! ,secret>y %all id5tify1 ?r\gh publication 9 ! ,f$]al ,regi/]1 any type ( class ,i device t ! ,secret>y det]m9es no long] requires a report "u subsection 7k7 to provide reasonable assurance ( safety & effectiv5ess4 ,^u su* publication-- 7,a7 ea* type ( class ,i device s id5tifi$ %all be exempt f ! requirem5t = a report "u subsection 7k72 & 7,b7 ! classification regulation applicable to ea* su* type ( device %all be deem$ am5d$ to incorporate su* exemption4 4 7b7 ,class ,,ii devices ,section #eaj7m7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj7m77 is am5d$-- 7#a7 by /rik+ p>agraph 7#a7 & ins]t+ ! foll[+ new p>agraph3 7#a7 ,! ,secret>y %all-- 7,a7 n lat] ?an #fj days aft] ! date ( ! enactm5t ( ! #ba/ ,c5tury ,cures ,act-- 7i7 publi% 9 ! ,f$]al ,regi/] a notice t conta9s a li/ ( ea* type ( class ,,ii device t ! ,secret>y det]m9es no long] requires a report "u subsection 7k7 to provide reasonable assurance ( safety & effectiv5ess2 & 7ii7 provide = a p]iod ( n less ?an #fj days = public comm5t beg9n+ on ! date ( ! publication ( su* notice2 & 7,b7 n lat] ?an #ahj days aft] ! date ( ! enactm5t ( #ba/ ,c5tury ,cures ,act1 publi% 9 ! ,f$]al ,regi/] a li/ repres5t+ ! ,secret>y's f9al det]m9ation ) respect to ! devices includ$ 9 ! li/ publi%$ "u subp>agraph 7,a74 2 7#b7 9 p>agraph 7#b7-- 7,a7 by /rik+ #a day aft] ! date ( ! publication ( a li/ "u ?is subsection1 & ins]t+ #a day aft] ! date ( publication ( ! f9al li/ "u p>agraph 7#a77;,b712 & 7,b7 by /rik+ #cj-;day p]iod & ins]t+ #fj-;day p]iod2 & 7#c7 by add+ at ! end ! foll[+ new p>agraph3 7#c7 ,^u ! publication ( ! f9al li/ "u p>agraph 7#a77;,b7-- 7,a7 ea* type ( class ,,ii device s li/$ %all be exempt f ! requirem5t = a report "u subsection 7k72 & 7,b7 ! classification regulation applicable to ea* su* type ( device %all be deem$ am5d$ to incorporate su* exemption4 4 #bbbf4 ,advisory committee process 7a7 ,classification panels ,p>agraph 7#e7 ( section #eac7;b7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;c7b77 is am5d$-- 7#a7 by /rik+ 7#e7 & ins]t+ 7#e77;,a72 & 7#b7 by add+ at ! end ! foll[+3 7,b7 ,:5 a device is specifically ! subject ( review by a classification panel1 ! ,secret>y %all-- 7i7 ensure t adequate exp]tise is repres5t$ on ! classification panel to assess-- 7,i7 ! disease or condition :i* ! device is int5d$ to cure1 treat1 mitigate1 prev5t1 or diagnose2 & 7,,ii7 ! te*nology ( ! device2 & 7ii7 z "p ( ! process to ensure adequate exp]tise "u clause 7i71 give due consid]ation to ! recomm5dations ( ! p]son ^: prem>ket submission is subject to panel review on ! exp]tise ne$$ among ! vot+ memb]s ( ! panel4 7,c7 ,= purposes ( subp>agraph 7,b77ii71 ! t]m adequate exp]tise means1 ) respect to ! memb]%ip ( ! classification panel review+ a prem>ket submission1 t su* memb]%ip includes-- 7i7 two or m vot+ memb]s1 ) a specialty or o!r exp]tise cl9ically relevant to ! device "u review2 & 7ii7 at lea/ "o vot+ memb] :o is kn[l$geable ab\t ! te*nology ( ! device4 4 7b7 ,panel review process ,section #eac7;b77#f7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;c7b77#f77 is am5d$-- 7#a7 9 subp>agraph 7,a77iii71 by ins]t+ be=e ! p]iod at ! end 1 includ+ by designat+ a repres5tative :o w be provid$ a "t dur+ ! panel meet+ to address ! panel individually 7or accompani$ by exp]ts select$ by su* repres5tative7 = ! purpose ( correct+ mis/atem5ts ( fact or provid+ cl>ify+ in=mation1 subject to ! discretion ( ! panel *airp]son2 & 7#b7 by /rik+ subp>agraph 7,b7 & ins]t+ ! foll[+ new subp>agraph3 7,b7 7i7 ,any meet+ ( a classification panel = a device t is specifically ! subject ( review %all-- 7,i7 provide adequate "t = initial pres5tations by ! p]son ^: device is specifically ! subject ( a classification panel review & by ! ,secret>y2 & 7,,ii7 enc\rage free & op5 p>ticipation by all int]e/$ p]sons4 7ii7 ,foll[+ ! initial pres5tations describ$ 9 clause 7i71 ! panel may-- 7,i7 pose que/ions to a designat$ repres5tative describ$ 9 subp>agraph 7,a77iii72 & 7,,ii7 consid] ! responses to su* que/ions 9 ! panel's review ( ! device t is specifically ! subject ( review by ! panel4 4 #bbbg4 ,humanit>ian device exemption application 7a7 ,9 g5]al ,section #ebj7m7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;j7 is am5d$-- 7#a7 9 p>agraph 7#a7 by /rik+ few] ?an #d1jjj & ins]t+ n m ?an #h1jjj2 7#b7 9 p>agraph 7#b77;,a7 by /rik+ few] ?an #d1jjj & ins]t+ n m ?an #h1jjj2 & 7#c7 9 p>agraph 7#f77;,a77ii71 by /rik+ #d1jjj & ins]t+ #h1jjj4 7b7 ,guidance docum5t on probable b5efit ,n lat] ?an #ah mon?s aft] ! date ( enactm5t ( ?is ,act1 ! ,secret>y ( ,heal? & ,human ,s]vices1 act+ ?r\gh ! ,commission] ( ,food & ,drugs1 %all publi% a draft guidance docum5t t def9es ! crit]ia = e/abli%+ probable b5efit z t t]m is us$ 9 section #ebj7m77#b77;,c7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;j7m77#b77;,c774 #bbbh4 ,,clia waiv] /udy design guidance = 9 vitro diagno/ics 7a7 ,draft revis$ guidance ,n lat] ?an #ab mon?s aft] ! date ( ! enactm5t ( ?is ,act1 ! ,secret>y ( ,heal? & ,human ,s]vices %all publi% a draft guidance t-- 7#a7 revises ,section ,v4 ,demon/rat+ ,insignificant ,risk ( an ,errone\s ,result--,accuracy ( ! guidance entitl$ ,recomm5dations = ,cl9ical ,laboratory ,improvem5t ,am5dm5ts ( #aihh 7,,clia7 ,waiv] ,applications = ,manufactur]s ( ,9 ,vitro ,diagno/ic ,devices & dat$ ,janu>y #cj1 #bjjh2 & 7#b7 includes guidance on ! appropriate use ( comp>able p]=mance betwe5 a waiv$ us] & a mod]ately complex laboratory us] to demon/rate accuracy4 7b7 ,f9al revis$ guidance ,! ,secret>y ( ,heal? & ,human ,s]vices %all f9alize ! draft guidance publi%$ "u subsection 7a7 n lat] ?an #ab mon?s aft] ! comm5t p]iod = su* draft guidance closes4 ,n ,s5sible ,ov]sight = ,te*nology ,:i* ,advances ,regulatory ,effici5cy #bbda4 ,heal? s(tw>e ,section #bja ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cba7 is am5d$ by add+ at ! end ! foll[+3 7ss7 7#a7 ,! t]m heal? s(tw>e means s(tw>e t does n1 ?r\gh use ( an 9 vitro diagno/ic device or signal acquisition sy/em1 acquire1 process1 or analyze an image or physiological signal1 is n an accessory1 is n an integral "p ( a device necess>y to support ! use ( ! device1 is n us$ 9 ! manufacture & transfusion ( blood & blood compon5ts to assi/ 9 ! prev5tion ( disease 9 humans1 &-- 7,a7 is int5d$ = use = adm9i/rative or op]ational support or ! process+ & ma9t5ance ( f9ancial records2 7,b7 is int5d$ = use 9 cl9ical1 laboratory1 or adm9i/rative workfl[ & relat$ recordkeep+2 7,c7 7i7 is int5d$ = use solely 9 ! transf]1 aggregation1 conv]sion 79 accordance ) a pres5t specification71 /orage1 managem5t1 retrieval1 or transmission ( data or in=mation2 7ii7 utilizes a connectivity s(tw>e plat=m1 electronic or electrical h>dw>e1 or a physical communications infra/ructure2 & 7iii7 is n int5d$ = use-- 7,i7 9 active pati5t monitor+2 or 7,,ii7 9 controll+ or alt]+ ! functions or p>amet]s ( a device t is connect$ to su* s(tw>e2 7,d7 is int5d$ = use to organize & pres5t in=mation = heal? or wellness education or = use 9 ma9ta9+ a heal?y life/yle1 includ+ m$ication adh]5ce & heal? managem5t tools2 7,e7 is int5d$ = use to analyze in=mation to provide g5]al heal? in=mation t does n include pati5t-specific recomm5d$ options to consid] 9 ! prev5tion1 diagnosis1 treatm5t1 cure1 or mitigation ( a p>ticul> disease or condition2 or 7,f7 is int5d$ = use to analyze in=mation to provide pati5t-specific recomm5d$ options to consid] 9 ! prev5tion1 diagnosis1 treatm5t1 cure1 or mitigation ( a p>ticul> disease or condition4 7#b7 ,! t]m accessory means a product t-- 7,a7 is int5d$ = use ) "o or m p>5t devices2 7,b7 is int5d$ to support1 supplem5t1 or augm5t ! p]=mance ( "o or m p>5t devices2 & 7,c7 %all be classifi$ by ! ,secret>y-- 7i7 accord+ to its int5d$ use2 & 7ii7 indep5d5tly ( any classification ( any p>5t device ) :i* x is us$4 4 #bbdb4 ,applicability & inapplicability ( regulation ,sub*apt] ,a ( *apt] ,v ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cea et seq471 z am5d$ by section #bbba7;a71 is fur!r am5d$ by add+ at ! end ! foll[+3 #ebd;,c4 ,heal? s(tw>e 7a7 ,inapplicability ( regulation to heal? s(tw>e ,except z provid$ 9 subsection 7b71 heal? s(tw>e %all n be subject to regulation "u ?is ,act4 7b7 ,exception 7#a7 ,9 g5]al ,subsection 7a7 %all n apply ) respect to a s(tw>e product-- 7,a7 ( a type describ$ 9 subp>agraph 7,f7 ( section #bja7ss77#a72 & 7,b7 t ! ,secret>y det]m9es poses a significant risk to pati5t safety4 7#b7 ,consid]ations ,9 mak+ a det]m9ation "u subp>agraph 7,b7 ( p>agraph 7#a7 ) respect to a product to :i* su* p>agraph applies1 ! ,secret>y %all consid] ! foll[+3 7,a7 ,! likelihood & sev]ity ( pati5t h>m if ! product 7 to n p]=m z int5d$4 7,b7 ,! ext5t to :i* ! product is int5d$ to support ! cl9ical judgm5t ( a m$ical pr(essional4 7,c7 ,:e!r !re is a reasonable opportunity = a m$ical pr(essional to review ! basis ( ! in=mation or treatm5t recomm5dation provid$ by ! product4 7,d7 ,! int5d$ us] & us] environm5t1 su* z :e!r a m$ical pr(essional w use a s(tw>e product ( a type describ$ 9 subp>agraph 7,f7 ( section #bja7ss77#a74 7c7 ,delegation ,! ,secret>y %all delegate prim>y jurisdiction = regulat+ a s(tw>e product det]m9$ "u subsection 7b7 to be subject to regulation "u ?is ,act to ! c5t] at ! ,food & ,drug ,adm9i/ration *>g$ ) regulat+ devices4 7d7 ,regulation ( s(tw>e 7#a7 ,9 g5]al ,! ,secret>y %all review exi/+ regulations & guidance reg>d+ ! regulation ( s(tw>e "u ?is ,act4 ,! ,secret>y may implem5t a new framework = ! regulation ( s(tw>e & %all1 z appropriate1 modify su* regulations & guidance or issue new regulations or guidance4 7#b7 ,issuance by ord] ,not)/&+ sub*apt] ,,ii ( *apt] #e ( title #e1 ,unit$ ,/ates ,code1 ! ,secret>y may modify or issue regulations = ! regulation ( s(tw>e "u ?is ,act by adm9i/rative ord] publi%$ 9 ! ,f$]al ,regi/] foll[+ ! publication ( a propos$ ord]4 7#c7 ,areas "u review ,! review ( exi/+ regulations & guidance "u p>agraph 7#a7 may include review ( ! foll[+ areas3 7,a7 ,classification ( s(tw>e4 7,b7 ,/&>ds = developm5t ( s(tw>e4 7,c7 ,/&>ds = validation & v]ification ( s(tw>e4 7,d7 ,review ( s(tw>e4 7,e7 ,modifications to s(tw>e4 7,f7 ,manufactur+ ( s(tw>e4 7,g7 ,quality sy/ems = s(tw>e4 7,h7 ,label+ requirem5ts = s(tw>e4 7,i7 ,po/m>ket+ requirem5ts = report+ ( adv]se ev5ts4 7#d7 ,process = issu+ propos$ regulations1 adm9i/rative ord]1 & guidance ,n lat] ?an #ah mon?s aft] ! date ( enactm5t ( ?is section1 ! ,secret>y %all consult ) ext]nal /akehold]s 7includ+ pati5ts1 indu/ry1 heal? c>e provid]s1 academia1 & gov]nm5t7 to ga!r input be=e issu+ regulations1 an adm9i/rative ord]1 & guidance "u ?is subsection4 7e7 ,rule ( con/ruction ,no?+ 9 ?is section %all be con/ru$ z provid+ ! ,secret>y ) ! au?ority to regulate "u ?is ,act any heal? s(tw>e product ( ! type describ$ 9 subp>agraph 7,f7 ( section #bja7ss77#a7 unless & until ! ,secret>y has made a det]m9ation describ$ 9 subsection 7b77#a77;,b7 ) respect to su* product4 4 #bbdc4 ,exclusion f def9ition ( device ,section #bja7;h7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cba7 is am5d$-- 7#a7 9 subp>agraph 7#b71 by /rik+ or aft] or o!r animals12 7#b7 9 subp>agraph 7#c71 by /rik+ & & ins]t+ or2 & 7#c7 by ins]t+ aft] subp>agraph 7#c7 ! foll[+3 7#d7 n heal? s(tw>e 7o!r ?an s(tw>e det]m9$ to be a risk to pati5t safety "u section #ebd;,b7b771 & 4 ,o ,/reaml9+ ,cl9ical ,trials #bbfa4 ,protection ( human subjects 9 rese>*2 applicability ( rules 7a7 ,9 g5]al ,9 ord] to simplify & facilitate compliance by rese>*]s ) applicable regulations = ! protection ( human subjects 9 rese>*1 ! ,secret>y ( ,heal? & ,human ,s]vices %all1 to ! ext5t possible & consi/5t ) o!r /atutory provisions1 h>monize diff]5ces betwe5 ! ,,hhs ,human ,subject ,regulations & ! ,,fda ,human ,subject ,regulations 9 accordance ) subsection 7b74 7b7 ,avoid+ regulatory duplication & unnecess>y delays 7#a7 ,9 g5]al ,! ,secret>y %all-- 7,a7 make su* modifications to ! provisions ( ! ,,hhs ,human ,subject ,regulations1 ! ,,fda ,human ,subject ,regulations1 & ! vuln]able-populations rules z may be necess>y-- 7i7 to r$uce regulatory duplication & unnecess>y delays2 7ii7 to mod]nize su* provisions 9 ! context ( multisite & coop]ative rese>* projects2 & 7iii7 to incorporate local consid]ations1 community values1 & me*anisms to protect vuln]able populations2 & 7,b7 ensure t human subject rese>* t is subject to ! ,,hhs ,human ,subject ,regulations or to ! ,,fda ,human ,subject ,regulations may-- 7i7 use jo9t or %>$ review2 7ii7 rely ^u ! review (-- 7,i7 an indep5d5t in/itutional review bo>d2 or 7,,ii7 an in/itutional review bo>d ( an entity o!r ?an ! sponsor ( ! rese>*2 or 7iii7 use simil> arrangem5ts to avoid duplication ( ef=t4 7#b7 ,regulations & guidance ,n lat] ?an #cf mon?s aft] ! date ( enactm5t ( ?is ,act1 ! ,secret>y1 act+ ?r\gh ! relevant ag5cies & (fices ( ! ,dep>tm5t ( ,heal? & ,human ,s]vices1 includ+ ! ,(fice = ,human ,rese>* ,protections & relevant ag5cies & (fices ( ! ,food & ,drug ,adm9i/ration1 %all issue su* regulations & guidance & take su* o!r actions z may be necess>y to implem5t ?is section & help to facilitate ! broad] use ( s+le1 c5tral1 or lead in/itutional review bo>ds4 ,su* regulations & guidance %all cl>ify ! requirem5ts & policies relat+ to ! foll[+3 7,a7 ,arrangem5ts to avoid duplication describ$ 9 p>agraph 7#a77;,a77i71 includ+-- 7i7 del9eat+ ! roles ( in/itutional review bo>ds 9 multisite or coop]ative1 multisite /udies :]e "o or m local in/itutional review bo>ds are reli$ ^u1 or simil> arrangem5ts are us$2 7ii7 ! risks & b5efits to human subjects2 7iii7 /&>diz+ ! in=m$ cons5t & o!r processes & legal docum5ts2 & 7iv7 incorporat+ community values ?r\gh ! use ( local in/itutional review bo>ds :ile cont9u+ to use c5tral or lead in/itutional review bo>ds4 7,b7 ,conc]ns ab\t regulatory & legal liability contribut+ to decisions by ! sponsors ( rese>* to rely on local in/itutional review bo>ds = multisite rese>*4 7#c7 ,consultation ,9 issu+ regulations or guidance "u p>agraph 7#b71 ! ,secret>y %all consult ) /akehold]s 7includ+ rese>*]s1 academic organizations1 hospitals1 in/itutional rese>* bo>ds1 ph>maceutical1 biote*nology & m$ical device develop]s1 cl9ical rese>* organizations1 pati5t gr\ps1 & o!rs74 7c7 ,tim+ ,! ,secret>y %all complete ! h>monization describ$ 9 subsection 7a7 n lat] ?an #cf mon?s aft] ! date ( enactm5t ( ?is ,act4 7d7 ,progress report ,n lat] ?an #bd mon?s aft] ! date ( enactm5t ( ?is ,act1 ! ,secret>y %all submit to ,congress a report on ! progress made t[>d complet+ su* h>monization4 7e7 ,draft ,,nih policy ,n lat] ?an #ab mon?s aft] ! date ( enactm5t ( ?is ,act1 ! ,secret>y1 act+ ?r\gh ! ,director ( ! ,national ,in/itutes ( ,heal?1 %all f9alize ! draft policy entitl$ ,draft ,,nih ,policy on ,use ( a ,s+le ,in/itutional ,review ,bo>d = ,multi-,site ,rese>*4 7f7 ,def9itions 7#a7 ,human subject regulations ,9 ?is section3 7,a7 ,,fda human subject regulations ,! t]m ,,fda ,human ,subject ,regulations means ! provisions ( p>ts #ej1 #ef1 #cab1 & #hab ( title #ba1 ,code ( ,f$]al ,regulations 7or any successor regulations74 7,b7 ,,hhs human subject regulations ,! t]m ,,hhs ,human ,subject ,regulations means ! provisions ( subp>t ,a ( "p #df ( title #de1 ,code ( ,f$]al ,regulations 7or any successor regulations74 7,c7 ,vuln]able-populations rules ,! t]m vuln]able-populations rules-- 7i7 subject to clause 7ii71 means ! provisions ( subp>ts ,b ?r\gh ,d ( su* "p #df 7or any successor regulations72 or 7ii7 z applicable to rese>* t is subject to ! ,,fda ,human ,subject ,regulations1 means ! provisions applicable to vuln]able populations "u "p #ef ( su* title #ba 7or any successor regulations7 & subp>t ,d ( "p #ej ( su* title #ba 7or any successor regulations74 7#b7 ,o!r def9itions ,9 ?is section3 7,a7 ,in/itutional review bo>d ,! t]m in/itutional review bo>d has ! mean+ t applies to ! t]m in/itutional review bo>d "u ! ,,hhs ,human ,subject ,regulations4 7,b7 ,lead in/itutional review bo>d ,! t]m lead in/itutional review bo>d means an in/itutional review bo>d t o!rwise meets ! requirem5ts ( ! ,,hhs ,human ,subject ,regulations & ent]s into a writt5 agreem5t ) an in/itution1 ano!r in/itutional review bo>d1 a sponsor1 or a pr9cipal inve/igator to approve & ov]see human subject rese>* t is conduct$ at multiple locations4 ,ref]5ces to an in/itutional review bo>d include an in/itutional review bo>d t s]ves a s+le in/itution z well z a lead in/itutional review bo>d4 #bbfb4 ,use ( non-local in/itutional review bo>ds = review ( inve/igational device exemptions & human device exemptions 7a7 ,9 g5]al ,section #ebj ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj7;j77 is am5d$-- 7#a7 9 subsection 7g77#c7-- 7,a7 by /rik+ local ea* place x appe>s2 & 7,b7 9 subp>agraph 7,a77i71 by /rik+ :i* has be52 & 7#b7 9 subsection 7m77#d7-- 7,a7 by /rik+ local ea* place x appe>s2 & 7,b7 by /rik+ subp>agraph 7,a7 & ins]t+ ! foll[+ new subp>agraph3 7,a7 9 facilities 9 :i* cl9ical te/+ ( devices is sup]vis$ by an in/itutional review committee e/abli%$ 9 accordance ) ! regulations ( ! ,secret>y1 & 4 7b7 ,regulations ,n lat] ?an #ab mon?s aft] ! date ( ! enactm5t ( ?is ,act1 ! ,secret>y ( ,heal? & ,human ,s]vices %all revise or issue su* regulations or guidance z may be necess>y to c>ry out ! am5dm5ts made by subsection 7a74 #bbfc4 ,alt]ation or waiv] ( in=m$ cons5t = cl9ical inve/igations 7a7 ,devices ,section #ebj7;g77#c7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;j7g77#c77 is am5d$-- 7#a7 9 subp>agraph 7,d71 by /rik+ except :]e subject to su* conditions z ! ,secret>y may prescribe1 ! inve/igator & ins]t+ ! foll[+3 except :]e1 subject to su* conditions z ! ,secret>y may prescribe-- 7i7 ! propos$ cl9ical te/+ poses no m ?an m9imal risk to ! human subject & includes appropriate safegu>ds to protect ! rights1 safety1 & welf>e ( ! human subject2 or 7ii7 ! inve/igator 2 & 7#b7 9 ! matt] foll[+ subp>agraph 7,d71 by /rik+ subp>agraph 7,d7 & ins]t+ subp>agraph 7,d77ii74 7b7 ,drugs ,section #eje7;i77#d7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cee7;i77#d77 is am5d$ by /rik+ except :]e x is n feasible or x is contr>y to ! be/ int]e/s ( su* human be+s & ins]t+ except :]e x is n feasible1 x is contr>y to ! be/ int]e/s ( su* human be+s1 or ! propos$ cl9ical te/+ poses no m ?an m9imal risk to su* human be+s & includes appropriate safegu>ds z prescrib$ to protect ! rights1 safety1 & welf>e ( su* human be+s4 ,p ,improv+ ,sci5tific ,exp]tise & ,outrea* at ,,fda #bbha4 ,silvio ,o4 ,conte ,s5ior ,biom$ical ,rese>* ,s]vice 7a7 ,hir+ & ret5tion au?ority ,section #bbh ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bcg7 is am5d$-- 7#a7 9 ! section head+1 by ins]t+ & ,biom$ical ,product ,assessm5t aft] ,rese>*2 7#b7 9 subsection 7a77#a71 by /rik+ ,silvio ,o4 ,conte ,s5ior ,biom$ical ,rese>* ,s]vice1 n to exce$ #ejj memb]s & ins]t+ ,silvio ,o4 ,conte ,s5ior ,biom$ical ,rese>* & ,biom$ical ,product ,assessm5t ,s]vice 79 ?is section ref]r$ to z ! ,s]vice71 ! purpose ( :i* is to recruit & reta9 competitive & qualifi$ sci5tific & te*nical exp]ts out/&+ 9 ! field ( biom$ical rese>*1 cl9ical rese>* evaluation1 & biom$ical product assessm5t2 7#c7 by am5d+ subsection 7a77#b7 to read z foll[s3 7#b7 ,! au?ority e/abli%$ 9 p>agraph 7#a7 may n be con/ru$ to require ! ,secret>y to r$uce ! numb] ( employees s]v+ "u any o!r employm5t sy/em 9 ord] to (fset ! numb] ( memb]s s]v+ 9 ! ,s]vice4 2 7#d7 9 subsection 7b7-- 7,a7 9 ! matt] prec$+ p>agraph 7#a71 by /rik+ or cl9ical rese>* evaluation & ins]t+ 1 cl9ical rese>* evaluation or biom$ical product assessm5t2 & 7,b7 9 p>agraph 7#a71 by ins]t+ or a ma/]'s level degree 9 eng9e]+1 bio9=matics1 or a relat$ or em]g+ field1 aft] ! comma2 7#e7 9 subsection 7d77#b71 by /rik+ & %all n exce$ ! rate payable = level ,i ( ! ,executive ,s*$ule unless approv$ by ! ,presid5t "u section #ecgg7;d77#b7 ( title #e1 ,unit$ ,/ates ,code & ins]t+ & %all n exce$ ! rate payable = ! ,presid5t2 7#f7 by /rik+ subsection 7e72 & 7#g7 by r$esignat+ subsections 7f7 & 7g7 z subsections 7e7 & 7f71 respectively4 7b7 ,report ,n lat] ?an #c ye>s aft] ! date ( ! enactm5t ( ?is ,act1 ! ,secret>y ( ,heal? & ,human ,s]vices %all submit1 & publi% on ! website ( ! ,dep>tm5t ( ,heal? & ,human ,s]vices a report on ! implem5tation ( ! am5dm5ts made by subsection 7a71 includ+ :e!r ! am5dm5ts h improv$ ! ability ( ! ,food & ,drug ,adm9i/ration to hire & reta9 qualifi$ exp]ts to fulfill obligations specifi$ "u us] fee agreem5ts4 #bbhb4 ,enabl+ ,,fda sci5tific engagem5t ,x is ! s5se ( ,congress t ! p>ticipation 91 or sponsor%ip (1 sci5tific conf]5ces & meet+s is ess5tial to ! mission ( ! ,food & ,drug ,adm9i/ration4 #bbhc4 ,reagan-,udall ,f\ndation = ! ,food & ,drug ,adm9i/ration 7a7 ,bo>d ( ,directors 7#a7 ,composition & size ,section #ggj7;d77#a77;,c7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;dd7d77#a77;,c77 is am5d$-- 7,a7 by r$esignat+ clause 7ii7 z clause 7iii72 7,b7 by ins]t+ aft] clause 7i7 ! foll[+3 7ii7 ,additional memb]s ,! ,bo>d1 ?r\gh am5dm5ts to ! bylaws ( ! ,f\ndation1 may provide t ! numb] ( vot+ memb]s ( ! ,bo>d %all be a numb] 7to be specifi$ 9 su* am5dm5t7 great] ?an #ad4 ,any ,bo>d positions t are e/abli%$ by any su* am5dm5t %all be appo9t$ 7by majority vote7 by ! individuals :o1 z ( ! date ( su* am5dm5t1 are vot+ memb]s ( ! ,bo>d & p]sons s appo9t$ may repres5t any ( ! categories specifi$ 9 subclauses 7,i7 ?r\gh 7,v7 ( clause 7i71 s long z no m ?an #cj p]c5t ( ! total vot+ memb]s ( ! ,bo>d 7includ+ memb]s ^: positions are e/abli%$ by su* am5dm5t7 are repres5tatives ( ! g5]al ph>maceutical1 device1 food1 cosmetic1 & biote*nology indu/ries4 2 & 7,c7 9 clause 7iii77,i71 z r$esignat$ by subp>agraph 7,a71 by /rik+ ,! ex (ficio memb]s %all ensure & ins]t+ ,! ex (ficio memb]s1 act+ pursuant to clause 7i71 & ! ,bo>d1 act+ pursuant to clause 7ii71 %all ensure4 7#b7 ,f$]al employees all[$ to s]ve on ,bo>d ,clause 7iii77,,ii7 ( section #ggj7;d77#a77;,c7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;dd7d77#a77;,c771 z r$esignat$ by p>agraph 7#a77;,a71 is am5d$ by add+ at ! end ! foll[+3 ,= purposes ( ?is section1 ! t]m employee ( ! ,f$]al ,gov]nm5t does n include a special ,gov]nm5t employee1 z t t]m is def9$ 9 section #bjb7;a7 ( title #ah1 ,unit$ ,/ates ,code44 7#c7 ,/agg]$ t]ms ,subp>agraph 7,a7 ( section #ggj7;d77#c7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;dd7d77#c77 is am5d$ to read z foll[s3 7,a7 ,t]m ,! t]m ( (fice ( ea* memb] ( ! ,bo>d appo9t$ "u p>agraph 7#a77;,c77i71 & ! t]m ( (fice ( any memb] ( ! ,bo>d ^: position is e/abli%$ pursuant to p>agraph 7#a77;,c77ii71 %all be #d ye>s1 except t-- 7i7 ! t]ms ( (fices = ! memb]s ( ! ,bo>d initially appo9t$ "u p>agraph 7#a77;,c77i7 %all expire on a /agg]$ basis z det]m9$ by ! ex (ficio memb]s2 & 7ii7 ! t]ms ( (fice = ! p]sons initially appo9t$ to positions e/abli%$ pursuant to p>agraph 7#a77;,c77ii7 may be made to expire on a /agg]$ basis1 z det]m9$ by ! individuals :o1 z ( ! date ( ! am5dm5t e/abli%+ su* positions1 are memb]s ( ! ,bo>d4 4 7b7 ,executive ,director comp5sation ,section #ggj7;g77#b7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;dd7g77#b77 is am5d$ by /rik+ b %all n be great] ?an ! comp5sation ( ! ,commission]4 7c7 ,sep>ation ( ,funds ,section #ggj7m7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;dd7m77 is am5d$ by /rik+ are held 9 sep>ate acc\nts f funds receiv$ f entities "u subsection 7i7 & ins]t+ are manag$ z individual programmatic funds "u subsection 7i71 accord+ to be/ acc\nt+ practices4 #bbhd4 ,collection ( c]ta9 volunt>y in=mation exempt$ f ,pap]work ,r$uction ,act ,*apt] ,,vii ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act is am5d$ by ins]t+ aft] section #gjh ( su* ,act 7#ba ,u4,s4,c4 #cgi7 ! foll[+3 #gjh;,a4 ,collection ( c]ta9 volunt>y in=mation exempt$ f ,pap]work ,r$uction ,act ,*apt] #ce ( title #dd1 ,unit$ ,/ates ,code1 %all n apply to ! collection f pati5ts1 indu/ry1 academia1 & o!r /akehold]s1 ( volunt>y in=mation su* z ?r\gh volunt>y surveys or que/ionnaires1 initiat$ by ! ,secret>y4 4 #bbhe4 ,hir+ au?ority = sci5tific1 te*nical1 & pr(essional p]sonnel 7a7 ,9 g5]al ,! ,f$]al ,food1 ,drug1 & ,cosmetic ,act is am5d$ by ins]t+ aft] section #gad 7#ba ,u4,s4,c4 #cgi;d-#c7 ! foll[+3 #gad;,a4 ,additional hir+ au?ority 7a7 ,9 g5]al ,! ,secret>y may1 )\t reg>d to ! provisions ( title #e1 ,unit$ ,/ates ,code1 gov]n+ appo9tm5ts 9 ! competitive s]vice1 appo9t qualifi$ c&idates to sci5tific1 te*nical1 or pr(essional positions )9 ! foll[+ c5t]s ( ! ,food & ,drug ,adm9i/ration3 7#a7 ,! ,c5t] = ,drug ,evaluation & ,rese>*4 7#b7 ,! ,c5t] = ,biologics ,evaluation & ,rese>*4 7#c7 ,! ,c5t] = ,devices & ,radiological ,heal?4 ,su* positions %all be )9 ! competitive s]vice4 7b7 ,comp5sation 7#a7 ,9 g5]al ,not)/&+ any o!r provision ( law1 includ+ any requirem5t ) respect to ,g5]al ,s*$ule pay rates "u sub*apt] ,,iii ( *apt] #ec ( title #e1 ,unit$ ,/ates ,code1 & consi/5t ) ! requirem5ts ( p>agraph 7#b71 ! ,secret>y may det]m9e & fix-- 7,a7 ! annual rate ( pay ( any individual appo9t$ "u subsection 7a72 & 7,b7 = purposes ( reta9+ qualifi$ employees1 ! annual rate ( pay = any highly qualifi$ sci5tific1 te*nical1 or pr(essional p]sonnel appo9t$ to a position at any ( ! c5t]s li/$ "u subsection 7a7 be=e ! date ( enactm5t ( ?is section4 7#b7 ,limitation ,! annual rate ( pay e/abli%$ pursuant to p>agraph 7#a7 may n exce$ ! annual rate ( pay ( ! ,presid5t4 7c7 ,report 7#a7 ,9 g5]al ,n lat] ?an ,septemb] #cj1 #bjba1 ! ,secret>y %all submit a report to ,congress t exam9es ! ext5t to :i* ! au?ority to appo9t & reta9 p]sonnel "u ?is section enhanc$ ! ,food & ,drug ,adm9i/ration's ability to meet ! ag5cy's critical ne$ = highly qualifi$ individuals = sci5tific1 te*nical1 or pr(essional positions4 7#b7 ,recomm5dations ,! report "u p>agraph 7#a7 %all include ! recomm5dations ( ! ,secret>y on-- 7,a7 :e!r ! au?ority to appo9t p]sonnel "u ?is section %\ld be reau?oriz$2 & 7,b7 o!r p]sonnel au?orities t w\ld help ! ,food & ,drug ,adm9i/ration to bett] recruit & reta9 highly qualifi$ individuals = sci5tific1 te*nical1 or pr(essional positions 9 ! ag5cy's m$ical product c5t]s4 4 7b7 ,rule ( con/ruction ,! au?ority provid$ by section #gad;,a ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7z add$ by subsection 7a77 %all n be con/ru$ to affect ! au?ority provid$ "u section #gad ( su* ,act4 ,q ,exempt+ f seque/ration c]ta9 us] fees #bcja4 ,exempt+ f seque/ration c]ta9 us] fees ( ,food & ,drug ,adm9i/ration ,! ,balanc$ ,budget & ,em]g5cy ,deficit ,control ,act ( #aihe is am5d$-- 7#a7 9 section #bee7;g77#a77;,a7 7#b ,u4,s4,c4 #ije7;g77#a77;,a771 by ins]t+ aft] ! item relat+ to ,f9ancial ,ag5t ,s]vices ! foll[+ new item3 ,food & ,drug ,adm9i/ration1 ,sal>ies & ,exp5ses1 b only ! portion ( appropriations "u su* acc\nt correspond+ to fees collect$ "u sections #gcf1 #gch1 #gdj1 #gda1 #gdd;,b1 & #gdd;,h ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ge-iiaa-j-a-eed74 2 & 7#b7 9 section #bef7;h7 7#b ,u4,s4,c4 #ijf7;h771 by add+ at ! end ! foll[+ new p>agraph3 7#e7 ,not)/&+ any o!r provision ( law1 ?is subsection %all n apply ) respect to ! portion ( adm9i/rative exp5ses incurr$ by ! ,food & ,drug ,adm9i/ration t are fund$ ?r\gh fees collect$ "u sections #gcf1 #gch1 #gdj1 #gda1 #gdd;,b1 & #gdd;,h ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act4 4 ,r ,o!r provisions #bcba4 ,s5se ( ,congress ,x is ! s5se ( ! ,congress t record+ unique device id5tifi]s at ! po9t-(-c>e 9 electronic heal? record sy/ems c\ld significantly enhance ! availability ( m$ical device data = po/m>ket surveillance purposes4 ,,iii ,deliv]y ,a ,int]op]ability #cjja4 ,ensur+ int]op]ability ( heal? in=mation te*nology 7a7 ,int]op]ability /&>ds 7#a7 ,9 g5]al ,subtitle ,a ( title ,,xxx ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #cjj;jj-#aa et seq47 is am5d$ by add+ at ! end ! foll[+ new section3 #cjaj4 ,ensur+ int]op]ability ( heal? in=mation te*nology 7a7 ,int]op]ability ,9 ord] = heal? in=mation te*nology to be consid]$ int]op]able1 su* te*nology mu/ satisfy ! foll[+ crit]ia3 7#a7 ,secure transf] ,! te*nology all[s ! secure transf] ( all electronically accessible heal? in=mation to & f any & all heal? in=mation te*nology = au?oriz$ use "u applicable ,/ate or ,f$]al law4 7#b7 ,complete ,access to ,heal? ,in=mation ,! te*nology all[s = complete access1 ex*ange1 & use ( all electronically accessible heal? in=mation = au?oriz$ use "u applicable ,/ate or ,f$]al law )\t special ef=t by ! reque/or ( su* heal? in=mation4 7#c7 ,no in=mation block+ ,! te*nology is n configur$1 set up1 or implem5t$ to in=mation block1 z def9$ 9 section #cjaj;,a7d74 7b7 ,categories = int]op]ability /&>ds ,! categories describ$ 9 ?is subsection1 ) respect to /&>ds & ! correspond+ implem5tation specifications = det]m9+ if heal? in=mation te*nology is int]op]able1 consi/5t ) ! crit]ia describ$ 9 subsection 7a71 include at lea/ categories ( /&>ds & implem5tation specifications ) respect to ! foll[+3 7#a7 ,vocabul>y & t]m9ology4 7#b7 ,cont5t & /ructure4 7#c7 ,transport4 7#d7 ,security4 7#e7 ,s]vices4 7#f7 ,qu]y+ & reque/+ heal? in=mation = access1 ex*ange1 & use4 7c7 ,all[+ = flexibility ,a /&>d & implem5tation specification1 ) respect to su* /&>d1 t is det]m9$ "u section #cjja7;c77#e77;,d7 to be compatible ) basel9e /&>ds & implem5tation specifications 7z def9$ 9 clause 7ii7 ( su* section7 %all be treat$ z 9 compliance ) ?is section4 4 7#b7 ,guidance ,n lat] ?an ,janu>y #a1 #bjag1 ! ,secret>y ( ,heal? & ,human ,s]vices1 9 consultation ) ! ,national ,coord9ator ( ! ,(fice ( ! ,national ,coord9ator = ,heal? ,in=mation ,te*nology1 %all issue guidance ) respect to ! implem5tation ( section #cjaj ( ! ,public ,heal? ,s]vice ,act1 z add$ by p>agraph 7#a71 includ+ ) respect to def9+ & provid+ examples ( au?oriz$ use "u applicable ,/ate or ,f$]al law ( heal? in=mation4 7b7 ,improvem5ts to recomm5dation process 7#a7 ,,hit ,policy ,committee to incorporate policies = updates to int]op]ability /&>ds ,section #cjjb ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #cjj;jj-#ab7 is am5d$-- 7,a7 9 subsection 7a7-- 7i7 by /rik+ ,national ,coord9ator & ins]t+ ,secret>y1 9 consultation ) ! ,national ,coord9ator12 & 7ii7 by add+ at ! end ! foll[+ new s5t5ce3 ,! ,,hit ,policy ,committee is au?oriz$ only to provide policy & priority recomm5dations to ! ,secret>y & n au?oriz$ to o!rwise affect ! developm5t or modification ( any /&>d1 implem5tation specification1 or c]tification crit]ion "u ?is title42 & 7,b7 9 subsection 7b77#b7-- 7i7 9 subp>agraph 7,a71 9 ! fir/ s5t5ce-- 7,i7 by /rik+ ,! ,,hit ,policy ,committee & ins]t+ ,subject to subp>agraph 7,d71 ! ,,hit ,policy ,committee2 & 7,,ii7 by ins]t+ 7includ+ ! areas 9 :i* modifications & additions to int]op]ability /&>ds & implem5tation specifications1 ) respect to su* int]op]ability /&>ds1 "u section #cjaj are ne$$ = ! electronic access1 ex*ange1 & use ( heal? in=mation = purposes ( adoption ( su* modifications & additions "u section #cjjd7 aft] section #cjjd4 7ii7 by add+ at ! end ! foll[+ new subp>agraph3 7,d7 ,special rule relat$ to int]op]ability ,any recomm5dation made by ! ,,hit ,policy ,committee on or aft] ! date ( ! enactm5t ( ?is subp>agraph ) respect to int]op]ability ( heal? in=mation te*nology %all be consi/5t ) ! crit]ia describ$ 9 subsection 7a7 ( section #cjaj4 4 7#b7 ,sunset ( ,,hit ,/&>ds ,committee ,section #cjjc ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #cjj;jj-#ac7 is am5d$ by add+ at ! end ! foll[+ new subsection3 7f7 ,t]m9ation ,! ,,hit ,/&>ds ,committee %all t]m9ate on ! date t is #ij days aft] ! date ( ! enactm5t ( ?is subsection4 4 7#c7 ,/&>ds developm5t organizations ,title ,,xxx ( ! ,public ,heal? ,s]vice ,act is am5d$ by ins]t+ aft] section #cjjc ! foll[+ new section3 #cjjc;,a4 ,recomm5dations = /&>ds ?r\gh contracts ) /&>ds developm5t organizations 7a7 ,contracts 7#a7 ,9 g5]al ,= purposes ( activities conduct$ "u ?is title1 ! ,secret>y %all ent] into "o or m contracts ) heal? c>e /&>ds developm5t organizations accr$it$ by ! ,am]ican ,national ,/&>ds ,in/itute 7or ) ! ,am]ican ,national ,/&>ds ,in/itute7 to c>ry out1 directly or ?r\gh contracts ) subcontractors1 ! duties describ$ 9 subsection 7b71 z applicable4 7#b7 ,tim+ = fir/ contract ,z soon z practicable aft] ! date ( ! enactm5t ( ?is section1 ! ,secret>y %all ent] into ! fir/ contracts "u p>agraph 7#a74 7#c7 ,p]iod ( contract ,ea* contract "u p>agraph 7#a7 %all be = a p]iod det]m9$ necess>y by ! ,secret>y1 9 consultation ) ! ,national ,coord9ator1 to c>ry out ! applicable duties describ$ 9 subsection 7b74 7#d7 ,appropriate entities ,! ,secret>y %all ensure ! mo/ appropriate entities describ$ 9 p>agraph 7#a7 are select$ = ea* contract "u su* p>agraph4 7b7 ,duties 7#a7 ,initial contract ,! ,secret>y %all initially ent] into "o or m contracts "u subsection 7a77#a7 ) entities describ$ 9 su* subsection1 "u :i* ! entities-- 7,a7 %all recomm5d to ! ,secret>y-- 7i7 = adoption "u section #cjjd1 an initial set ( int]op]ability /&>ds & implem5tation specifications1 ) respect to su* /&>ds1 id5tifi$ or1 z appropriate1 develop$ by su* entities t are consi/5t ) ! crit]ia describ$ 9 subsection 7a7 ( section #cjaj1 & ) respect to ! categories describ$ 9 subsection 7b7 ( su* section2 & 7ii7 z applicable1 = purposes ( section #cjja7;c77#e77;,d71 me?ods to te/ if heal? in=mation te*nology is compatible ) heal? in=mation te*nology t applies basel9e /&>ds & implem5tation specifications 7z def9$ 9 clause 7ii7 ( su* section72 & 7,b7 may provide to ! ,secret>y recomm5dations describ$ 9 p>agraph 7#b74 7#b7 ,subsequ5t contracts ,"u ea* subsequ5t contract ent]$ into "u ?is section ) entities describ$ 9 subsection 7a77#a7 pursuant to subsection 7c71 ! entities %all recomm5d to ! ,secret>y-- 7,a7 = adoption "u section #cjjd any /&>ds 7includ+ int]op]ability /&>ds71 implem5tation specifications1 &1 to ! ext5t necess>y1 c]tification crit]ia 7& modifications1 includ+ additions1 to su* /&>ds1 specifications1 &1 to ! ext5t necess>y1 crit]ia71 :i* are 9 accordance ) ! crit]ia describ$ 9 section #cjaj2 & 7,b7 z applicable1 = purposes ( section #cjja7;c77#e77;,d71 me?ods to te/ if heal? in=mation te*nology is compatible ) basel9e /&>ds & implem5tation specifications 7z def9$ 9 clause 7ii7 ( su* section74 7#c7 ,submission to ,,ni/ ,"u ea* contract ) an entity "u ?is section1 ! entity %all submit to ! ,director ( ! ,national ,in/itute ( ,/&>ds & ,te*nology ea* recomm5dation submitt$ to ! ,secret>y by su* entity "u ?is section4 7#d7 ,consultation ,= ! purposes ( develop+ me?ods to te/ int]op]ability /&>ds & implem5tation specifications ) respect to su* /&>ds1 ! entities ) a contract "u ?is section may consult ) ! ,director ( ! ,national ,in/itute ( ,/&>ds & ,te*nology4 7c7 ,modifications & subsequ5t contracts 7#a7 ,9 g5]al ,! ,secret>y1 9 consultation ) ! ,national ,coord9ator1 %all p]iodically conduct he>+s to evaluate & review ! /&>ds1 implem5tation specifications1 & c]tification crit]ia adopt$ "u section #cjjd = purposes ( det]m9+ if modifications1 includ+ any additions1 are ne$$ ) respect to su* /&>ds1 specifications1 & crit]ia4 7#b7 ,contract trigg] ,bas$ on ! ne$s = /&>ds1 implem5tation specifications1 & c]tification crit]ia 7& modifications1 includ+ additions1 to su* /&>ds1 specifications1 & crit]ia7 "u ?is title1 z det]m9$ by ! ,secret>y1 ) due consid]ation to section #cjaj7;b7 & 9 consultation ) ! ,national ,coord9ator1 ! ,secret>y %all1 z ne$$1 ent] into contracts "u subsection 7a7 to c>ry out ! duties describ$ 9 subsection 7b77#b7 9 addition to any contract ent]$ into to c>ry out ! duties describ$ 9 subsection 7b77#a74 7d7 ,au?orization ( appropriations ,!re is au?oriz$ to be appropriat$ #aj1jjj1jjj = contracts "u subsection 7a71 to rema9 available until exp5d$4 4 7#d7 ,modifications to role ( ! ,national ,coord9ator ,section #cjja7;c77#a77;,a7 ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #cjj;jj-#aa7;c77#a77;,a77 is am5d$ by ins]t+ = recomm5dations made be=e ! date ( ! enactm5t ( ! #ba/ ,c5tury ,cures ,act1 be=e review & det]m9e4 7c7 ,adoption ,section #cjjd ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #cjj;jj-#ad7 is am5d$-- 7#a7 9 subsection 7a7-- 7,a7 9 p>agraph 7#a71 by ins]t+ aft] section #cjja7;c7 ! foll[+3 7or1 subject to subsection 7c71 9 ! case ( a /&>d1 implem5tation specification1 or crit]ion recomm5d$ on or aft] ! date ( ! enactm5t ( ! #ba/ ,c5tury ,cures ,act1 aft] ! date ( submission ( ! recomm5dation to ! ,secret>y "u section #cjjc;,a72 & 7,b7 9 p>agraph 7#b77;,b71 by /rik+ & ! ,,hit ,/&>ds ,committee2 7#b7 9 subsection 7b7-- 7,a7 9 p>agraph 7#c71 by /rik+ ) ! s*$ule publi%$ "u section #cjjc7;b77#b7 & ins]t+ ) subsection 7d72 & 7,b7 by add+ at ! end ! foll[+ new p>agraph3 7#d7 ,limitation ,! ,secret>y may n adopt any policies1 priorities1 /&>ds1 implem5tation specifications1 or c]tification crit]ia "u ?is subsection or subsection 7a7 t are inconsi/5t ) or duplicative ( an int]op]ability /&>d or implem5tation specification ) respect to su* /&>d adopt$ "u ?is section1 9 accordance ) subsections 7c7 & 7d74 ,9 ! case ( a /&>d1 specification1 or crit]ion t has be5 adopt$ "u ?is section & is inconsi/5t or duplicative ( su* an int]op]ability /&>d or specification t is subsequ5tly adopt$ "u ?is section1 su* int]op]ability /&>d or specification %all sup]c$e su* o!r /&>d1 specification1 or crit]ion & su* o!r /&>d1 specification1 or crit]ion %all no long] be consid]$ adopt$ "u ?is section beg9n+ on ! date t su* int]op]ability /&>d or specification becomes effective4 2 & 7#c7 by add+ at ! end ! foll[+ new subsections3 7c7 ,adoption ( initial int]op]ability /&>ds & implem5tation specifications ,not)/&+ ! previ\s subsections ( ?is section1 ! foll[+ %all apply 9 ! case ( ! initial set ( int]op]ability /&>ds & implem5tation specifications ) respect to su* /&>ds recomm5d$ "u section #cjjc;,a3 7#a7 ,review ( /&>ds ,n lat] ?an #ij days aft] ! date ( receipt ( recomm5dations = su* int]op]ability /&>ds & implem5tation specifications1 ! ,secret>y1 9 consultation ) ! ,national ,coord9ator & repres5tatives ( o!r relevant ,f$]al ag5cies1 su* z ! ,national ,in/itute ( ,/&>ds & ,te*nology1 %all jo9tly review su* /&>ds & implem5tation specifications & %all det]m9e :e!r or n to propose adoption ( su* /&>ds & implem5tation specifications4 7#b7 ,det]m9ation to adopt ,if1 subject to subsection 7d77#c71 ! ,secret>y det]m9es-- 7,a7 to propose adoption ( su* /&>ds & implem5tation specifications1 ! ,secret>y %all1 by regulation "u section #eec ( title #e1 ,unit$ ,/ates ,code1 det]m9e :e!r or n to adopt su* /&>ds & implem5tation specifications2 or 7,b7 n to propose adoption ( su* /&>ds & implem5tation specifications1 ! ,secret>y %all notify ! applicable entity ) a contract "u section #cjjc;,a 9 writ+ ( su* det]m9ation & ! reasons = n propos+ ! adoption ( ! recomm5dation = su* /&>ds & implem5tation specifications4 7#c7 ,publication ,! ,secret>y %all provide = publication 9 ! ,f$]al ,regi/] ( all det]m9ations made by ! ,secret>y "u p>agraph 7#a74 7d7 ,rules = adoption ,9 ! case ( a /&>d 7includ+ int]op]ability /&>d71 implem5tation specification1 or c]tification crit]ion adopt$ "u ?is section on or aft] ! date ( ! enactm5t ( ! #ba/ ,c5tury ,cures ,act1 ! foll[+ %all apply3 7#a7 ,9 g5]al ,except z provid$ 9 p>agraphs 7#b7 & 7#c71 any su* /&>d 7includ+ int]op]ability /&>d71 implem5tation specification1 or c]tification crit]ion %all be a /&>d1 specification1 or crit]ion t has be5 recomm5d$ by ! entities ) :i* ! ,secret>y has ent]$ into a contract "u section #cjjc;,a4 7#b7 ,special rule if no /&>d1 specification1 or crit]ion recomm5d$ ,if no /&>d1 implem5tation specification1 or1 to ! ext5t necess>y1 c]tification crit]ion is recomm5d$ "u p>agraph 7#a7-- 7,a7 9 ! case ( int]op]ability /&>ds & implem5tation specifications ) respect to su* /&>ds1 relat+ to a category describ$ 9 section #cjaj7;b7-- 7i7 p>agraph 7#a7 %all n apply2 & 7ii7 p>agraph 7#d7 %all apply2 or 7,b7 9 ! case ( any o!r /&>d1 implem5tation specification1 or1 to ! ext5t necess>y1 c]tification crit]ion1 relat+ to a policy or priority to c>ry out ?is title1 z det]m9$ by ! ,secret>y1 9 consultation ) ! ,national ,coord9ator-- 7i7 p>agraph 7#a7 %all n apply2 & 7ii7 p>agraph 7#d7 %all apply4 7#c7 ,au?ority to modify implem5tation specifications ,if1 foll[+ public comm5t pursuant to subsection 7c71 ! ,secret>y w\ld propose adoption ( int]op]ability /&>ds recomm5d$ "u section #cjjc;,a b = ! implem5tation specifications1 ) respect to su* /&>ds1 s recomm5d$1 ! ,secret>y may modify su* implem5tation specifications & adopt su* /&>ds & specifications 9 accordance ) subsection 7c77#b74 7#d7 ,effective date ,9 ! case ( a /&>d1 implem5tation specification1 or c]tification crit]ion = :i* !re is a det]m9ation to adopt su* /&>d1 implem5tation specification1 or c]tification crit]ion1 su* /&>d1 implem5tation specification1 or c]tification crit]ion %all be consid]$ adopt$ "u ?is section & %all be effective beg9n+ on ! date t is #ab mon?s aft] ! date ( publication ( ! f9al rule to adopt su* /&>d1 implem5tation specification1 or c]tification crit]ion4 7#e7 ,assi/ance to ! ,secret>y ,9 comply+ ) ! requirem5ts ( ?is subsection1 ! ,secret>y %all give due consid]ation to any recomm5dations ( ! ,national ,committee on ,vital & ,heal? ,/ati/ics e/abli%$ "u section #cjf7k71 & %all consult ) appropriate ,f$]al & ,/ate ag5cies & private organizations4 ,! ,secret>y %all publi% 9 ! ,f$]al ,regi/] any recomm5dation ( ! ,national ,committee on ,vital & ,heal? ,/ati/ics reg>d+ ! adoption ( a /&>d1 implem5tation specification1 or c]tification crit]ion "u ?is section4 ,any /&>d1 implem5tation specification1 or c]tification crit]ion adopt$ pursuant to ?is p>agraph %all be promulgat$ 9 accordance ) ! rulemak+ proc$ures ( sub*apt] ,,iii ( *apt] #e ( title #e1 ,unit$ ,/ates ,code4 7e7 ,all[+ = flexibility ?r\gh compatibility ) basel9e /&>ds & implem5tation specifications ,= purposes ( ?is title1 title ,,xviii ( ! ,social ,security ,act1 title ,,xix ( su* ,act1 & any o!r provision ( law1 a /&>d & implem5tation specification1 ) respect to su* /&>d1 t is det]m9$ "u section #cjja7;c77#e77;,d7 to be compatible ) basel9e /&>ds & implem5tation specifications 7z def9$ 9 clause 7ii7 ( su* section7 %all be treat$ z if su* /&>d & specification 7 an int]op]ability /&>d & implem5tation specification1 ) respect to su* int]op]ability /&>d1 adopt$ "u ?is section4 4 7d7 ,reports & notifications ,section #cjaj ( ! ,public ,heal? ,s]vice ,act1 z add$ by subsection 7a71 is am5d$ by add+ at ! end ! foll[+ new subsection3 7c7 ,dissem9ation ( in=mation 7#a7 ,initial summ>y report ,n lat] ?an ,july #a1 #bjag1 ! ,secret>y1 aft] consultation ) relevant /akehold]s1 %all submit to ,congress & provide = publication 9 ! ,f$]al ,regi/] & ! po/+ on ! ,int]net website ( ! ,(fice ( ! ,national ,coord9ator = ,heal? ,in=mation ,te*nology a report on ! foll[+3 7,a7 ,! initial set ( int]op]ability /&>ds & implem5tation specifications adopt$ "u section #cjjd7;c74 7,b7 ,! /rategies = a*iev+ widespread int]op]ability4 7,c7 ,any b>ri]s t are prev5t+ widespread int]op]ability4 7,d7 ,! plan & mile/ones1 includ+ specific /eps1 to a*ieve widespread int]op]ability4 7#b7 ,ongo+ publication ( recomm5dations ,! ,secret>y %all provide = publication 9 ! ,f$]al ,regi/]1 & ! po/+ on ! ,int]net website ( ! ,(fice ( ! ,national ,coord9ator = ,heal? ,in=mation ,te*nology1 ( all recomm5dations made "u ?is section4 4 7e7 ,c]tification & o!r en=cem5t provisions 7#a7 ,c]tification ( qualifi$ electronic heal? records 7,a7 ,9 g5]al ,section #cjjg7;b7 ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #cjj;jj-#ag7;b77 is am5d$ by /rik+ "u section #cjja7;c77#c7 to be 9 compliance ) & all t foll[s ?r\gh ! p]iod at ! end & ins]t+ "u section #cjja7;c77#c7-- 7#a7 = c]tifications made be=e ,janu>y #a1 #bjah1 to be 9 compliance ) applicable /&>ds adopt$ "u subsections 7a7 & 7b7 ( section #cjjd2 & 7#b7 = c]tifications made on or aft] ,janu>y #a1 #bjah1 to be 9 compliance ) applicable /&>ds adopt$ "u subsections 7a7 & 7b7 ( section #cjjd & to be int]op]able 9 accordance ) section #cjaj & 9 compliance ) int]op]ability /&>ds adopt$ "u section #cjjd4 4 7,b7 ,requirem5ts ( ,secret>y ,section #cjja7;c77#e7 ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #cjj;jj-#aa7;c77#e77 is am5d$-- 7i7 9 subp>agraph 7,b71 by ins]t+ be=e ! p]iod at ! end ! foll[+3 &1 = c]tifications made on or aft] ,janu>y #a1 #bjah1 ) respect to heal? in=mation te*nology1 additional crit]ia to e/abli% t ! te*nology is int]op]able1 9 accordance ) section #cjaj1 & 9 compliance ) int]op]ability /&>ds & implem5tation specifications1 ) respect to su* /&>ds1 adopt$ "u section #cjjd2 & 7ii7 by add+ at ! end ! foll[+ new subp>agraphs3 7,c7 ,en=cem5t2 dec]tifications 7i7 ,requirem5ts ,"u any program kept or recogniz$ "u subp>agraph 7,a71 ! ,secret>y %all ensure t any v5dor ( or o!r entity (f]+ to heal? c>e provid]s 7z def9$ 9 section #cjaj;,a7g77 qualifi$ electronic heal? records seek+ a c]tification ( su* records "u su* program on or aft] ,janu>y #a1 #bjah1 %all1 z a condition ( c]tification 7& ma9t5ance ( c]tification7 ( su* a record "u su* program-- 7,i7 provide to ! ,secret>y an atte/ation-- 7aa7 ! entity has implem5t$ int]op]ability /&>ds & implem5tation specifications1 ) respect to su* /&>ds1 adopt$ "u section #cjjd 7includ+ ?r\gh application ( subsection 7e7 ( su* section72 7bb7 t ! entity1 unless = a legitimate purpose specifi$ by ! ,secret>y1 has n tak5 & w n take any action t con/itutes in=mation block+ 7z def9$ 9 section #cjaj;,a7d771 ) respect to su* qualifi$ electronic heal? records2 7cc7 t includes ! pric+ in=mation describ$ 9 clause 7iii7 = purposes ( inclusion "u subsection 7f7 ( su* in=mation on ! ,int]net website ( ! ,dep>tm5t ( ,heal? & ,human ,s]vices2 t su* in=mation w be available on a public ,int]net website ( su* entity2 & t ! entity w volunt>ily provide su* in=mation to cu/om]s prior to (f]+ any qualifi$ electronic heal? records or relat$ product or s]vice 7includ+ subsequ5t updates1 add-ons1 or additional products or s]vices to be provid$ dur+ ! c\rse ( an on-go+ contract71 prospective cu/om]s 7su* z p]sons :o reque/ or receive a quotation or e/imate71 & o!r p]sons :o reque/ su* in=mation2 7dd7 t ! te*nology ) respect to su* records has publi%$ application programm+ int]faces1 ) respect to heal? in=mation )9 su* records1 = se>* & index+1 semantic h>monization & vocabul>y translation1 & us] int]face applications2 7ee7 t ! entity has successfully & rigor\sly te/$ ! real _w use ( ! record 9 ! type ( sett+ 9 :i* x w\ld be m>ket$2 & 7ff7 t ! entity has 9 place data %>+ programs or capabilities bas$ on common data elem5ts ?r\gh su* me*anisms z application programm+ int]faces )\t ! requirem5t = v5dor-specific int]faces2 7,,ii7 publi% application programm+ int]faces & associat$ docum5tation1 ) respect to heal? in=mation )9 su* records1 = se>* & index+1 semantic h>monization & vocabul>y translation1 & us] int]face applications2 & 7,,iii7 demon/rate to ! satisfaction ( ! ,secret>y t heal? in=mation f su* records are able to be ex*ang$1 access$1 & us$ ?r\gh ! use ( application programm+ int]faces )\t special ef=t1 z au?oriz$ "u applicable law4 7ii7 ,dec]tification ,"u any program kept or recogniz$ "u subp>agraph 7,a71 ! ,secret>y %all ensure t beg9n+ ,janu>y #a1 #bjai1 any qualifi$ electronic heal? records t d n satisfy ! c]tification crit]ia describ$ 9 subp>agraph 7,b7 or ) respect to :i* ! v5dor or o!r entity describ$ 9 clause 7i7 does n satisfy ! requirem5ts "u su* clause 7or is det]m9$ to be 9 violation ( ! t]ms ( ! atte/ation or o!r requirem5ts "u su* clause7 %all no long] be consid]$ z c]tifi$ "u su* program4 7iii7 ,pric+ in=mation ,= purposes ( clause 7i77,i77cc71 ! pric+ in=mation describ$ 9 ?is clause1 ) respect to a v5dor ( or o!r entity (f]+ a qualifi$ electronic heal? record1 is ! foll[+3 7,i7 ,additional types ( co/s or fees 7:e!r fix$1 recurr+1 transaction bas$1 or o!rwise7 impos$ by ! entity 7or any ?ird-p>ty f :om ! entity pur*ases1 lic5ses1 or obta9s any te*nology1 products1 or s]vices 9 connection ) ! qualifi$ electronic heal? record7 to pur*ase1 lic5se1 implem5t1 ma9ta91 upgrade1 use1 or o!rwise enable & support ! use ( capabilities to :i* su* record is to be c]tifi$ "u ?is section2 or 9 connection ) any heal? in=mation g5]at$ 9 ! c\rse ( us+ any capability to :i* ! record is to be s c]tifi$4 7,,ii7 ,limitations1 :e!r by contract or o!rwise1 on ! use ( any capability to :i* ! record is to be c]tifi$ "u ?is section = any purpose )9 ! scope ( ! record's c]tification2 or 9 connection ) any heal? in=mation g5]at$ 9 ! c\rse ( us+ any capability to :i* ! record is to be c]tifi$ "u ?is section4 7,,iii7 ,limitations1 includ+ te*nical or practical limitations ( te*nology or its capabilities1 t c\ld prev5t or impair ! successful implem5tation1 configuration1 cu/omization1 ma9t5ance1 support1 or use ( any capabilities to :i* ! record is to be c]tifi$ "u ?is section2 or t c\ld prev5t or limit ! access1 use1 ex*ange1 or portability ( any heal? in=mation g5]at$ 9 ! c\rse ( us+ any capability to :i* ! record is to be s c]tifi$4 7,d7 ,flexibility ?r\gh compatibility 7i7 ,9 g5]al ,"u any program kept or recogniz$ "u subp>agraph 7,a71 ! ,secret>y %all provide = a me?od & process by :i* a v5dor ( or o!r entity (f]+ to heal? c>e provid]s 7z def9$ 9 section #cjaj;,a7g77 qualifi$ electronic heal? records seek+ a c]tification ( su* records "u su* program on or aft] ,janu>y #a1 #bjah1 may demon/rate1 us+ su* me*anisms z a ref]5ce implem5tation model or o!r means1 t ! /&>ds & implem5tation specifications appli$ by su* entity ) respect to su* records are compatible ) basel9e /&>ds & implem5tation specifications1 includ+ by demon/rat+ su* records are able to transmit in=mation t is compatible ) qualifi$ electronic heal? records t w\ld receive su* in=mation & t apply ! basel9e /&>ds & implem5tation specifications4 ,su* a me?od & process %all ensure t any su* entity us+ a /&>d or implem5tation specification o!r ?an a basel9e /&>d or implem5tation specification demon/rates1 ?r\gh te/+1 compatibility ) ! basel9e /&>d & implem5tation specification ) respect to receiv+ in=mation4 7ii7 ,basel9e /&>ds & implem5tation specifications ,= purposes ( clause 7i71 ! t]m basel9e /&>ds & implem5tation specifications means ! int]op]ability /&>ds & implem5tation specifications1 ) respect to su* /&>ds1 adopt$ "u section #cjjd 7)\t application ( subsection 7e7 ( su* section74 4 7#b7 ,additional en=cem5t provisions "u ! ,public ,heal? ,s]vice ,act ,subtitle ,a ( title ,,xxx ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #cjj;jj-#aa et seq471 z am5d$ by subsections 7a77#a7 & 7d71 is fur!r am5d$ by add+ at ! end ! foll[+ new section3 #cjaj;,a4 ,en=cem5t me*anisms 7a7 ,inspector ,g5]al au?ority ,! ,inspector ,g5]al ( ! ,dep>tm5t ( ,heal? & ,human ,s]vices %all h ! au?ority to inve/igate claims (-- 7#a7 7,a7 v5dors (1 or o!r entities (f]+ to heal? c>e provid]s 7z def9$ 9 subsection 7g771 qualifi$ electronic heal? records 7z def9$ 9 section #cjjj7ac77 be+ 9 violation ( an atte/ation 7:e!r provid+ false in=mation at ! "t ( su* atte/ation or by act or practice conduct$ aft] su* atte/ation7 made "u section #cjja7;c77#e77;,c77i77,i71 ) respect to ! use ( su* records by a heal? c>e provid] ) respect to items & s]vices furni%$ "u ! ,m$ic>e ,program "u title ,,xviii ( ! ,social ,security ,act or ,m$icaid program "u title ,,xix ( su* ,act2 & 7,b7 v5dors (1 or o!r entities (f]+ to heal? c>e provid]s 7z def9$ 9 subsection 7g771 heal? in=mation te*nology hav+ engag$ 9 in=mation block+ 7z def9$ 9 subsection 7d771 unless = a legitimate purpose specifi$ by ! ,secret>y1 ) respect to ! use ( su* te*nology by a heal? c>e provid] ) respect to items & s]vices furni%$ "u su* a program2 7#b7 heal? c>e provid]s hav+ engag$ 9 in=mation block+ 7z s def9$71 ) respect to ! use ( heal? in=mation te*nology ) respect to items & s]vices furni%$ "u su* a program1 unless = a legitimate purpose specifi$ by ! ,secret>y2 & 7#c7 heal? in=mation sy/em provid]s 7su* z op]ators ( heal? in=mation ex*anges1 cl9ical data regi/ries1 & o!r sy/ems t facilitate ! ex*ange ( in=mation7 hav+ engag$ 9 in=mation block+ 7z s def9$71 unless = a legitimate purpose specifi$ by ! ,secret>y1 ) respect to ! use ( heal? in=mation te*nology ) respect to items & s]vices furni%$ "u su* a program4 7b7 ,in=mation %>+ provisions 7#a7 ,9 g5]al ,! ,national ,coord9ator may s]ve z a te*nical consultant to ! ,inspector ,g5]al ( ! ,dep>tm5t ( ,heal? & ,human ,s]vices & ! ,f$]al ,trade ,commission = purposes ( c>ry+ out ?is section4 ,z su* te*nical consultant1 ! ,national ,coord9ator may1 not)/&+ any o!r provision ( law1 %>e in=mation relat$ to claims or inve/igations "u subsection 7a7 ) ! ,f$]al ,trade ,commission = purposes ( su* inve/igations & %all %>e in=mation ) ! ,inspector ,g5]al1 z requir$ by law4 7#b7 ,protection f disclosure ( in=mation ,any in=mation t is receiv$ by ! ,national ,coord9ator 9 connection ) a claim or sugge/ion ( possible in=mation block+ & t c\ld reasonably be expect$ to facilitate id5tification ( ! s\rce ( ! in=mation-- 7,a7 %all n be disclos$ by ! ,national ,coord9ator except z may be necess>y to c>ry out ! purpose ( ?is section2 & 7,b7 %all be exempt f m&atory disclosure "u section #eeb ( title #e1 ,unit$ ,/ates ,code1 z provid$ by subsection 7b77#c7 ( su* section4 ,su* in=mation may be us$ by ! ,inspector ,g5]al ( ! ,dep>tm5t ( ,heal? & ,human ,s]vices or ,f$]al ,trade ,commission = report+ purposes to ! ext5t t su* in=mation c\ld n reasonably be expect$ to facilitate id5tification ( ! s\rce ( su* in=mation4 7#c7 ,non-application ( ,pap]work ,r$uction ,act ,*apt] #ce ( title #dd1 ,unit$ ,/ates ,code 7commonly ref]r$ to z ! ,pap]work ,r$uction ,act ( #aiie7 %all n apply to ! ,national ,coord9ator or to ! ,(fice ( ! ,national ,coord9ator = ,heal? ,in=mation ,te*nology ) respect to ! collection ( compla9ts relat+ to claims describ$ 9 subsection 7a74 7#d7 ,/&>diz$ process ,! ,national ,coord9ator %all implem5t a /&>diz$ process = ! public to submit reports on claims (-- 7,a7 heal? in=mation te*nology products ( v5dors 7or o!r entities (f]+ su* products to heal? c>e provid]s 7z def9$ 9 subsection 7g777 n be+ int]op]able or result+ 9 in=mation block+2 or 7,b7 actions by su* entities1 heal? c>e provid]s1 or heal? in=mation sy/em provid]s t result 9 su* te*nology n be+ int]op]able or 9 in=mation block+ ) respect to su* te*nology2 & 7,c7 any o!r act describ$ 9 subsection 7a74 ,! /&>diz$ process %all provide = ! collection ( su* in=mation z ! orig9at+ in/itution1 location1 type ( transaction1 sy/em & v]sion1 time/amp1 t]m9at+ in/itution1 locations1 sy/em & v]sion1 failure notice1 & o!r relat$ in=mation4 7c7 ,p5alty 7#a7 ,9 g5]al ,any p]son or entity describ$ 9 p>agraph 7#a71 7#b71 or 7#c7 ( subsection 7a7 det]m9$ to h committ$ on or aft] ,janu>y #a1 #bjah1 an act describ$ 9 su* respective p>agraph ) respect to ! use ( a qualifi$ electronic heal? record or heal? in=mation te*nology1 z applicable "u su* respective p>agraph1 ) respect to items & s]vices furni%$ "u ! ,m$ic>e ,program "u title ,,xviii ( ! ,social ,security ,act or ! ,m$icaid program "u title ,,xix ( su* ,act1 %all be subject to a civil monet>y p5alty 9 su* am\nt z det]m9$ appropriate by ! ,secret>y ?r\gh rulemak+4 7#b7 ,application ,subject to p>agraph 7#c71 ! provisions ( section #aabh;,a 7o!r ?an subsections 7a7 & 7b77 ( su* ,act 7#db ,u4,s4,c4 #acbj;a-#g;a7 %all apply to a civil money p5alty appli$ "u ?is subsection 9 ! same mann] z !y apply to a civil money p5alty or proce$+ "u subsection 7a7 ( su* section #aabh;,a4 7#c7 ,recov]y ( funds ,not)/&+ section #ccjb ( title #ca1 ,unit$ ,/ates ,code1 or any o!r provision ( law affect+ ! cr$it+ ( collections1 ! ,inspector ,g5]al ( ! ,dep>tm5t ( ,heal? & ,human ,s]vices may receive & reta9 = curr5t use any am\nts recov]$ "u ?is subsection4 ,9 addition to am\nts o!rwise available to ! ,inspector ,g5]al1 funds receiv$ by ! ,inspector ,g5]al "u ?is p>agraph %all be deposit$1 z an (fsett+ collection1 to ! cr$it ( any appropriation available = purposes ( c>ry+ out ?is subsection & subsection 7a7 & %all be available )\t fiscal ye> limitation & )\t fur!r appropriation4 7d7 ,in=mation block+ 7#a7 ,9 g5]al ,= purposes ( ?is section & section #cjaj1 subject to p>agraph 7#c71 ! t]m in=mation block+ means1 ) respect to ! access1 use1 & ex*ange ( qualifi$ electronic heal? records & o!r heal? in=mation te*nology1 bus9ess1 te*nical1 & organizational practices1 includ+ practices describ$ 9 p>agraph 7#b71 t-- 7,a7 prev5t or mat]ially disc\rage ! access1 ex*ange1 or use ( electronic heal? in=mation2 & 7,b7 ! actor kn[s or %\ld "k 7z def9$ 9 section #aabh;,a7i77#g7 ( ! ,social ,security ,act7 are likely to int]f]e ) ! access1 ex*ange1 or use ( electronic heal? in=mation4 7#b7 ,practices describ$ ,= purposes ( p>agraph 7#a71 ! practices describ$ 9 ?is p>agraph %all include ! foll[+3 7,a7 ,contract t]ms1 policies1 or bus9ess or organizational practices t re/rict au?oriz$ use "u applicable ,/ate or ,f$]al law ( electronic heal? in=mation or re/rict ! au?oriz$ ex*ange "u applicable ,/ate or ,f$]al law ( su* in=mation = treatm5t & o!r p]mitt$ purposes "u su* applicable law1 includ+ transitions betwe5 c]tifi$ ,,ehr te*nologies4 7,b7 ,*>g+ unreasonable prices or fees 7su* z = heal? in=mation ex*ange1 portability1 int]faces1 & full export ( heal? in=mation7 t make access+1 ex*ang+1 or us+ electronic heal? in=mation co/ prohibitive4 7,c7 ,develop+ or implem5t+ heal? in=mation te*nology 9 non/&>d ways t are likely to sub/antially increase ! co/s1 complexity1 or burd5 ( %>+ electronic heal? in=mation1 especially 9 cases 9 :i* relevant int]op]ability /&>ds or me?ods to measure int]op]ability h be5 adopt$ by ! ,secret>y4 7,d7 ,develop+ or implem5t+ heal? in=mation te*nology 9 ways t are likely to lock 9 us]s or electronic heal? in=mation1 su* z n all[+ = ! full export ( heal? in=mation2 lead to fraud1 wa/e1 or abuse2 or imp$e innovations & advancem5ts 9 heal? in=mation access1 ex*ange1 & use1 includ+ heal? in=mation te*nology-enabl$ c>e deliv]y4 7#c7 ,exceptions 7,a7 ,9 g5]al ,! t]m in=mation block+ %all n include practices t-- 7i7 are requir$ by applicable law2 or 7ii7 t ! ,secret>y1 ?r\gh regulation1 id5tifies z necess>y to protect pati5t safety1 to ma9ta9 ! privacy or security ( individuals' heal? in=mation1 or to promote competition & consum] welf>e4 7,b7 ,process ,= purposes ( subp>agraph 7,a77ii71 n lat] ?an #ab mon?s aft] ! date ( ! enactm5t ( ?is section1 ! ,secret>y %all issue regulations foll[+ ! notice & comm5t proc$ures ( section #eec ( title #e1 ,unit$ ,/ates ,code1 except t ! ,secret>y may issue ! fir/ su* regulation z an int]im f9al regulation4 7,c7 ,no en=cem5t be=e exceptions id5tifi$ ,! t]m in=mation block+ %all n include any practice or conduct occurr+ be=e ! date t is #cj days aft] ! date on :i* ! fir/ regulation 7z describ$ 9 subp>agraph 7,b77 is issu$ "u su* subp>agraph4 7,d7 ,consultation ,to ! ext5t t regulations issu$ "u ?is p>agraph def9e practices t are necess>y to promote competition & consum] welf>e1 ! ,secret>y may consult ) ! ,f$]al ,trade ,commission 9 issu+ su* regulations4 7,e7 ,application ,! t]m in=mation block+1 ) respect to an individual or entity1 %all n include an act or practice o!r ?an an act or practice committ$ by su* individual or entity4 7e7 ,treatm5t ( v5dors ) respect to pati5t safety organizations ,9 apply+ "p ,c ( title ,,ix-- 7#a7 v5dors %all be treat$ z a provid] 7z def9$ 9 section #iba7 = purposes ( report+ requirem5ts "u su* "p1 to ! ext5t t su* reports are relat$ to atte/ation requirem5ts "u section #cjja7;c77#e77;,c77i77,i72 7#b7 claims ( in=mation block+ describ$ 9 subsection 7a7 %all be treat$ z a pati5t safety activity "u su* "p = purposes ( report+ requirem5ts "u su* "p2 & 7#c7 heal? c>e provid]s t are n memb]s ( pati5t safety organizations %all be treat$ 9 ! same mann] z heal? c>e provid]s t are su* memb]s = purposes ( su* report+ requirem5ts ) respect to claims ( in=mation block+ describ$ 9 subsection 7a74 7f7 ,rulemak+ & guidance 7#a7 ,9 g5]al ,n lat] ?an #ab mon?s aft] ! date ( ! enactm5t ( ?is section1 ! ,secret>y1 9 consultation ) ! ,national ,coord9ator & ! ,inspector ,g5]al ( ! ,dep>tm5t ( ,heal? & ,human ,s]vices1 %all1 ?r\gh rulemak+1 implem5t ! provisions ( section #cjja ( ! #ba/ ,c5tury ,cures ,act1 includ+ am5dm5ts made by su* section1 relat+ to in=mation block+4 7#b7 ,non-duplication ( p5alty /ructures ,9 c>ry+ out p>agraph 7#a71 9 det]m9+ ! scope ( p5alties1 assessm5ts1 or exclusions "u su* section #cjja1 includ+ am5dm5ts made by su* section1 relat+ to in=mation block+1 ! ,secret>y %all ensure to ! ext5t possible t su* p5alties1 assessm5ts1 & exclusions d n duplicate p5alty1 assessm5t1 & exclusion /ructures t w\ld o!rwise apply ) respect to in=mation block+ & ! type ( individual or entity involv$ z ( ! day be=e ! date ( ! enactm5t ( ?is section4 7#c7 ,cl>ification ,9 c>ry+ out p>agraph 7#a71 ! ,secret>y %all ensure t heal? c>e provid]s are n p5aliz$ = actions ( v5dor (1 & o!r entities (f]+ to su* provid]s1 heal? in=mation te*nology = ! failure ( su* te*nology to meet requirem5ts = su* te*nology to be c]tifi$ "u ?is title4 7#d7 ,guidance relat+ to ,,hipaa ,n lat] ?an ,janu>y #a1 #bjag1 ! ,national ,coord9ator %all publi% guidance to cl>ify ! relation%ip ( ! provisions ( ! ,,hipaa privacy & security law1 z def9$ 9 section #cjji7;a77#b7 to in=mation block+1 includ+-- 7,a7 examples ( h[ su* provisions may result 9 in=mation block+2 & 7,b7 cl>ify+ t a heal? c>e provid] 7z def9$ 9 subsection 7g77 :o discloses heal? in=mation z all[$ "u applicable ,/ate & ,f$]al law is n liable = unlawful actions1 includ+ brea*es t occur 9 ! cu/ody ( ! recipi5t unless ! disclosure proximately cause ! brea*4 7g7 ,heal? c>e provid] def9$ ,= purposes ( ?is section1 ! t]m heal? c>e provid] means a provid] ( s]vices "u subsection 7u7 ( section #ahfa ( ! ,social ,security ,act & a suppli] "u subsection 7d7 ( su* section4 7h7 ,au?orization ( appropriations ,9 addition to am\nts made available "u subsection 7c77#c71 !re is au?oriz$ to be appropriat$ #aj1jjj1jjj = fiscal ye> #bjag to c>ry out subsection 7a71 to rema9 available until exp5d$4 4 7#c7 ,po/+s relat+ to en=cem5t on ,,hhs ,int]net website ,section #cjja ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #cjj;jj-#aa7 is am5d$ by add+ at ! end ! foll[+ new subsection3 7f7 ,en=cem5t in=mation po/$ on ,,hhs ,int]net website 7#a7 ,pric+ in=mation ,n lat] ?an ,janu>y #a1 #bjai1 ! ,national ,coord9ator %all po/ ! in=mation describ$ 9 subsection 7c77#e77;,c77,i77i77cc7 on ! public ,int]net website ( ! ,(fice ( ! ,national ,coord9ator = ,heal? ,in=mation ,te*nology 9 a mann] t all[s = comp>ison ( functionality1 price in=mation1 & o!r features among heal? in=mation te*nology products t aids 9 mak+ in=m$ decisions = pur*as+ su* a product4 7#b7 ,annual po/+ ,= #bjai & ea* subsequ5t ye>1 ! ,secret>y %all po/ on ! public ,int]net website ( ! ,dep>tm5t ( ,heal? & ,human ,s]vices a li/ ( any qualifi$ electronic heal? records ) respect to :i* c]tification has be5 )drawn "u subsection 7c77#e77;,c77ii7 dur+ su* ye> & ! v5dor ( or o!r entity (f]+ to heal? c>e provid]s 7z def9$ 9 section #cjaj;,a7g77 su* qualifi$ electronic heal? records4 7#c7 ,p]iodic review ,! ,secret>y %all p]iodically review & confirm t v5dors ( & o!r entities (f]+ to heal? c>e provid]s 7z def9$ 9 section #cjaj;,a7g77 qualifi$ electronic heal? records h publicly publi%$ application programm+ int]faces & associat$ docum5tation z requir$ by subsection 7c77#e77;,c77i77,,ii7 = purposes ( c]tification & ma9ta9+ c]tification "u any program kept or recogniz$ "u subsection 7c77#e77;,a74 4 7#d7 ,demon/ration requir$ = mean+ful ,,ehr use "u ,m$ic>e 7,a7 ,eligible pr(essionals 7i7 ,9 g5]al ,section #ahdh7o77#b77;,a7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#d7o77#b77;,a77 is am5d$ by ins]t+ aft] clause 7iii7 ! foll[+ new clause3 7iv7 ,int]op]ability ,) respect to ,,ehr report+ p]iods = paym5t ye>s beg9n+ ) #bjbj1 ! eligible pr(essional demon/rates to ! satisfaction ( ! ,secret>y1 9 accordance ) subp>agraph 7,c77i71 t dur+ su* p]iod ! pr(essional has n tak5 any action describ$ 9 subsection 7a77#b7 ( section #cjaj;,a ( ! ,public ,heal? ,s]vice ,act1 ) respect to ! use ( any c]tifi$ ,,ehr te*nology4 4 7ii7 ,h>d%ip exemption 9 case ( dec]tifi$ ,,ehr ,subp>agraph 7,b7 ( section #ahdh7;a77#g7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#d7;a77#g77 is am5d$ to read z foll[s3 7,b7 ,significant h>d%ip exception 7i7 ,9 g5]al ,! ,secret>y may1 on a case-by-case basis1 exempt an eligible pr(essional f ! application ( ! paym5t adju/m5t "u subp>agraph 7,a7 if ! ,secret>y det]m9es1 subject to annual r5ewal1 t compliance ) ! requirem5t = be+ a mean+ful ,,ehr us] w\ld result 9 a significant h>d%ip1 su* z 9 ! case ( an eligible pr(essional :o practices 9 a rural area )\t suffici5t ,int]net access4 7ii7 ,dec]tification ,! ,secret>y %all exempt an eligible pr(essional f ! application ( ! paym5t adju/m5t "u subp>agraph 7,a7 if ! ,secret>y det]m9es t su* pr(essional 0 det]m9$ to n be a mean+ful ,,ehr us] because ! c]tifi$ ,,ehr te*nology us$ by su* pr(essional is dec]tifi$ "u section #cjja7;c77#e77;,c7 ( ! ,public ,heal? ,s]vice ,act4 ,an exemption "u ! previ\s s5t5ce may be appli$ to an eligible pr(essional only1 subject to clause 7iii71 dur+ ! fir/ paym5t ye> ) respect to ! fir/ ,,ehr report+ p]iod to :i* su* dec]tification applies4 7iii7 ,duration ( dec]tification 7,i7 ,9 g5]al ,not)/&+ clause 7iv77,i71 9 no case %all an exemption by reason ( clause 7ii7 be = a p]iod ( less ?an #ab mon?s4 7,,ii7 ,ext5sion ,an exemption "u clause 7ii7 may be ext5d$1 on a case-by-case basis1 = a p]iod ( an additional #ab mon?s subject to ! limitation describ$ 9 clause 7iv77,i74 7iv7 ,limitation 7,i7 ,9 g5]al ,subject to subclause 7,,ii71 9 no case may an eligible pr(essional be grant$ an exemption "u ?is subp>agraph = m ?an #e ye>s4 7,,ii7 ,exception ,subclause 7,i7 %all n apply to an exemption by reason ( clause 7ii7 to ! ext5t necess>y to satisfy clause 7iii77,i74 4 7iii7 ,fur!r application ,section #ahdh7o77#b7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#d7o77#b77 is am5d$ by add+ at ! end ! foll[+ new subp>agraph3 7,e7 ,h>d%ip exemption 9 case ( dec]tifi$ ,,ehr ,9 ! case ( c]tifi$ ,,ehr te*nology us$ by an eligible pr(essional t is dec]tifi$ "u section #cjja7;c77#e77;,c71 dur+ ! fir/ paym5t ye> ) respect to ! fir/ ,,ehr report+ p]iod to :i* su* dec]tification applies1 ! ,secret>y %all n treat ! pr(essional z n be+ a mean+ful ,,ehr us] solely because ! te*nology us$ by su* pr(essional 0 s dec]tifi$4 ,! treatm5t ( a pr(essional "u ! previ\s s5t5ce %all be = a p]iod ( at lea/ #ab mon?s & may1 on a case-by-case basis1 be = a p]iod ( an additional #ab mon?s4 4 7,b7 ,eligible hospitals 7i7 ,9 g5]al ,section #ahhf7n77#c77;,a7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acieww7n77#c77;,a77 is am5d$ by ins]t+ aft] clause 7iii7 ! foll[+ new clause3 7iv7 ,int]op]ability ,) respect to ,,ehr report+ p]iods = paym5t ye>s beg9n+ ) #bjbj1 ! hospital demon/rates to ! satisfaction ( ! ,secret>y1 9 accordance ) subp>agraph 7,c77i71 t dur+ su* p]iod ! hospital has n tak5 any action describ$ 9 subsection 7a77#b7 ( section #cjaj;,a ( ! ,public ,heal? ,s]vice ,act1 ) respect to ! use ( any c]tifi$ ,,ehr te*nology4 4 7ii7 ,h>d%ip exemption 9 case ( dec]tifi$ ,,ehr ,subclause 7,,ii7 ( section #ahhf7;b77#c77;,b77ix7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acieww7b77#c77;,b77ix77 is am5d$ to read z foll[s3 7,,ii7 7aa7 ,! ,secret>y may1 on a case-by-case basis1 exempt a subsection 7d7 hospital f ! application ( subclause 7,i7 ) respect to a fiscal ye> if ! ,secret>y det]m9es1 subject to annual r5ewal1 t requir+ su* hospital to be a mean+ful ,,ehr us] dur+ su* fiscal ye> w\ld result 9 a significant h>d%ip1 su* z 9 ! case ( a hospital 9 a rural area )\t suffici5t ,int]net access4 7bb7 ,! ,secret>y %all exempt a subsection 7d7 hospital f ! application ( subclause 7,i7 ) respect to a fiscal ye> if ! ,secret>y det]m9es t su* hospital 0 det]m9$ to n be a mean+ful ,,ehr us] because ! c]tifi$ ,,ehr te*nology us$ by su* hospital is dec]tifi$ "u section #cjja7;c77#e77;,c7 ( ! ,public ,heal? ,s]vice ,act4 ,an exemption "u ! previ\s s5t5ce may be appli$ to a subsection 7d7 hospital only1 subject to items 7cc7 & 7dd71 dur+ ! fir/ paym5t ye> ) respect to ! fir/ ,,ehr report+ p]iod to :i* su* dec]tification applies4 7cc7 ,not)/&+ item 7ee71 9 no case %all an exemption by reason ( item 7bb7 be = a p]iod ( less ?an #ab mon?s4 7dd7 ,an exemption "u item 7bb7 may1 on a case-by-case basis1 be ext5d$ = a p]iod ( an additional #ab mon?s subject to ! limitation describ$ 9 item 7ee74 7ee7 ,subject to item 7ff71 9 no case may a hospital be grant$ an exemption "u ?is subclause = m ?an #e ye>s4 7ff7 ,item 7ee7 %all n apply to an exemption by reason ( item 7bb7 to ! ext5t necess>y to satisfy item 7cc74 4 7,c7 ,demon/ration requir$ = mean+ful ,,ehr use "u ,m$icaid ,section #aijc7t77#b7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acif;b7t77#b77 is am5d$ by add+ at ! end ! foll[+3 ,an eligible pr(essional %all n qualify z a ,m$icaid provid] "u ?is subsection1 ) respect to a ye> beg9n+ ) #bjbj1 unless su* provid] demon/rates to ! ,secret>y1 ?r\gh means su* z an atte/ation1 t ! provid] has n tak5 any action describ$ 9 subsection 7a77#b7 ( section #cjaj;,a ( ! ,public ,heal? ,s]vice ,act1 ) respect to ! use ( any c]tifi$ ,,ehr te*nology44 7#e7 ,guidance ,n lat] ?an ,janu>y #a1 #bjah1 ! ,secret>y ( ,heal? & ,human ,s]vices %all issue guidance to fur!r ! volunt>y transition ( heal? c>e provid]s betwe5 diff]5t c]tifi$ ,,ehr te*nology 7z def9$ 9 section #cjjj7a7 ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #cjj;jj7#a77 by remov+ dis9c5tives to su* transition1 :i* may include apply+ to in/ances ( su* a transition ! h>d%ip exemption au?ority "u section #ahdh7;a77#g7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#d7;a77#g771 section #ahhf7;b77#c77;,b77ix7 ( su* ,act 7#db ,u4,s4,c4 #acieww7b77#c77;,b77ix771 & o!r provisions ( law 9 exi/5ce z ( ! date ( ! enactm5t ( ?is ,act4 ,9 develop+ su* guidance1 ! ,secret>y may consult ) ! relevant ,f$]al ag5cies4 7f7 ,def9itions 7#a7 ,c]tifi$ ,,ehr te*nology ,p>agraph 7#a7 ( section #cjjj ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #cjj;jj7 is am5d$ to read z foll[s3 7#a7 ,c]tifi$ ,,ehr te*nology ,! t]m c]tifi$ ,,ehr te*nology means a qualifi$ electronic heal? record t is c]tifi$ pursuant to section #cjja7;c77#e7 z meet+ ! c]tification crit]ia def9$ 9 subp>agraph 7,b7 ( su* section t are applicable to ! type ( record involv$ 7z det]m9$ by ! ,secret>y1 su* z an ambulatory electronic heal? record = (fice-bas$ physicians or an inpati5t hospital electronic heal? record = hospitals7 includ+1 beg9n+ ,janu>y #a1 #bjah1 ) respect to :i* ! v5dor or o!r entity (f]+ su* te*nology is 9 compliance ) ! requirem5ts "u section #cjja7;c77#e77;,c77i74 4 7#b7 ,widespread int]op]ability ,section #cjjj ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #cjj;jj7 is am5d$ by add+ at ! end ! foll[+ new p>agraph3 7#ae7 ,widespread int]op]ability ,! t]m widespread int]op]ability means t1 on a nationwide basis-- 7,a7 heal? in=mation te*nology is int]op]able1 9 accordance ) section #cjaj2 & 7,b7 su* te*nology is employ$ by mean+ful ,,ehr us]s "u ! ,m$ic>e ,program "u title ,,xviii ( ! ,social ,security ,act & ! ,m$icaid program "u title ,,xix ( su* ,act & by o!r cl9icians & heal? c>e provid]s4 4 7g7 ,con=m+ am5dm5ts 7#a7 ,volunt>y use ( /&>ds ,section #cjjf ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #cjj;jj-#af7 is am5d$-- 7,a7 9 subsection 7a77#a71 by ins]t+ 1 includ+ an int]op]ability /&>d or implem5tation specification1 ) respect to su* int]op]ability /&>d1 adopt$ "u su* section aft] section #cjjd4 7,b7 9 subsection 7b71 by ins]t+ 1 includ+ ! int]op]ability /&>ds & implem5tation specifications1 ) respect to su* int]op]ability /&>ds1 adopt$ "u su* section aft] section #cjjd4 7#b7 ,,hipaa privacy & security law def9ition correction ,section #cjji7;a77#b77;,a7 ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #cjj;jj-#ai7;a77#b77;,a77 is am5d$ by /rik+ title ,,iv & ins]t+ title ,,xiii4 7#c7 ,coord9ation ( ,f$]al activities ,section #acaaa ( ! ,,hite* ,act is am5d$-- 7,a7 9 subsection 7a71 by ins]t+ be=e ! p]iod at ! end ! foll[+3 7&1 beg9n+ on ,janu>y #a1 #bjah1 t are also int]op]able "u section #cjaj ( su* ,act & 9 compliance ) int]op]ability /&>ds & implem5tation specifications1 ) respect to su* int]op]ability /&>ds1 adopt$ "u section #cjjd ( su* ,act 72 & 7,b7 9 subsection 7b71 by ins]t+ 7&1 beg9n+ on ,janu>y #a1 #bjah1 includ+ an int]op]ability /&>d or implem5tation specification1 ) respect to su* int]op]ability /&>d1 adopt$ "u section #cjjd ( su* ,act7 be=e ! ,presid5t4 7#d7 ,application to private entities ,section #acaab ( ! ,,hite* ,act is am5d$ by ins]t+ be=e ! p]iod at ! end ! foll[+3 7&1 beg9n+ on ,janu>y #a1 #bjah1 t are also int]op]able "u section #cjaj ( su* ,act & 9 compliance ) int]op]ability /&>ds & implem5tation specifications1 ) respect to su* int]op]ability /&>ds1 adopt$ "u section #cjjd ( su* ,act74 7#e7 ,,ni/ te/+ ,section #acbja ( ! ,,hite* ,act 7#db ,u4,s4,c4 #agiaa7 is am5d$-- 7,a7 9 subsection 7a71 by ins]t+ 7or1 beg9n+ ,janu>y #a1 #bjah1 9 coord9ation ) ! entities ) contracts "u section #cjjc;,a1 ) respect to /&>ds1 & implem5tation specifications "u section #cjjd7 be=e 1 ! ,director2 7,b7 9 subsection 7b71 by ins]t+ 7or1 beg9n+ ,janu>y #a1 #bjah1 9 coord9ation ) ! entities ) contracts "u section #cjjc;,a1 ) respect to /&>ds & implem5tation specifications "u section #cjjd7 be=e 1 ! ,director2 & 7,c7 by add+ at ! end ! foll[+ new subsection3 7c7 ,fund+ ,= purposes ( c>ry+ out ?is section1 9 addition to any o!r funds made available to c>ry out ?is section1 !re is au?oriz$ to be appropriat$ #ae1jjj1jjj1 to rema9 available until exp5d$4 4 7#f7 ,coord9ation ) recomm5dations = a*iev+ widespread ,,ehr int]op]ability ,section #ajf ( ! ,m$ic>e ,access & ,,*ip ,reau?orization ,act ( #bjae 7,public ,law #aad-aj7 is am5d$ by /rik+ subsection 7b74 4 7h7 ,pati5t engagem5t & emp[]m5t ,x is ! s5se ( ,congress t-- 7#a7 if ! /rategic goals t ,congress set =? 9 ! ,,hite* ,act are to be a*iev$1 int]op]ability is be/ a*iev$ ) individuals & au?oriz$ repres5tatives hav+ equal access to ! heal? in=mation ( su* individuals 9 electronic =mat2 7#b7 pati5ts h ! "r to ! entirety ( ! heal? in=mation ( su* individuals1 includ+ su* in=mation conta9$ 9 an electronic heal? record ( su* individuals2 7#c7 su* "r ext5ds to bo? /ructur$ & un/ructur$ data2 7#d7 su* "r ext5ds to au?oriz$ repres5tatives ( ! individual involv$1 su* z c>etak]s ( su* individual1 family memb]s ( su* individual1 & gu>dians ( su* individual2 & 7#e7 to fur!r facilitate access ( an individual to heal? in=mation ( su* individual-- 7,a7 heal? c>e provid]s %\ld n h ! ability to d5y a reque/ ( ! individual = access to ! entirety ( su* heal? in=mation ( su* individual2 7,b7 heal? c>e provid]s d n ne$ ! cons5t ( individuals to %>e p]sonal heal? in=mation ( su* individuals ) o!r cov]$ entities1 9 compliance ) ! ,,hipaa privacy regulations promulgat$ pursuant to section #bfd7;c7 ( ! ,heal? ,insurance ,portability & ,acc\ntability ,act ( #aiif = ! purposes ( support+ pati5t c>e1 except 9 situations :]e cons5t is specifically requir$ "u su* regulations1 su* z 9 cases relat$ to ! psy*iatric records ( ! individual involv$2 7,c7 me*anisms %\ld be utiliz$ t all[ = ! bidirectional ex*ange ( in=mation ?r\gh su* me*anisms z web portals1 appo9tm5ts1 & prescription refills1 = ! purpose ( pati5ts p>tn]+ ) provid]s to assi/ 9 manag+ heal? & c>e2 7,d7 me*anisms describ$ 9 subp>agraph 7,c7 %\ld all[ = connect+ individuals across ! cont9uum ( c>e2 7,e7 an individual has ! "r to access ! heal? in=mation ( ! individual )\t co/ to ! individual2 7,f7 me*anisms describ$ 9 subp>agraph 7,c7 %\ld all[ = data ( an individual g5]at$ by ! individual to be integrat$ into su* plat=ms z electronic heal? records2 7,g7 su* access %\ld be timely1 9 accordance ) ! ,,hipaa privacy regulations describ$ 9 subp>agraph 7,b71 & take into acc\nt communications pref]5ces ( ! individual involv$2 7,h7 an individual %\ld h ! "r to be confid5t t ! data 9 ! electronic heal? record ( ! individual p]ta9s to su* individual2 & 7,i7 ! "r describ$ 9 subp>agraph 7,h7 w promote safety & c>e coord9ation = individuals4 ,b ,teleheal? #cjba4 ,teleheal? s]vices "u ! ,m$ic>e ,program 7a7 ,provision ( in=mation by ,c5t]s = ,m$ic>e ,m$icaid ,s]vices ,n lat] ?an #a ye> aft] ! date ( ! enactm5t ( ?is ,act1 ! ,adm9i/rator ( ! ,c5t]s = ,m$ic>e ,m$icaid ,s]vices %all provide to ! committees ( jurisdiction ( ! ,h\se ( ,repres5tatives & ! ,s5ate in=mation on ! foll[+3 7#a7 ,! populations ( ,m$ic>e b5efici>ies1 su* z ^? :o are dually eligible = ! ,m$ic>e ,program "u title ,,xviii ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acie et seq47 & ! ,m$icaid program "u title ,,xix ( su* ,act 7#db ,u4,s4,c4 #acif et seq47 & ^? ) *ronic conditions1 ^: c>e may be improv$ mo/ 9 t]ms ( quality & effici5cy by ! expansion1 9 a mann] t meets or exce$s ! exi/+ 9-p]son /&>d ( c>e "u ! ,m$ic>e ,program "u title ,,xviii ( su* ,act1 ( teleheal? s]vices "u section #ahcd7m77#d7 ( su* ,act 7#db ,u4,s4,c4 #aciem7m77#d774 7#b7 ,activities by ! ,c5t] = ,m$ic>e & ,m$icaid ,innovation :i* exam9e ! use ( teleheal? s]vices 9 models1 projects1 or initiatives fund$ ?r\gh section #aaae;,a ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acae;a74 7#c7 ,! types ( high-volume s]vices 7& relat$ diagnoses7 "u su* title ,,xviii :i* might be suitable to ! furni%+ ( s]vices via teleheal?4 7#d7 ,b>ri]s t might prev5t ! expansion ( teleheal? s]vices "u section #ahcd7m77#d7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciem7m77#d77 beyond su* s]vices t are 9 effect z ( ! date ( ! enactm5t ( ?is ,act4 7b7 ,provision ( in=mation by ,med,p,a,c ,n lat] ?an ,m>* #ae1 #bjag1 ! ,m$ic>e ,paym5t ,advisory ,commission e/abli%$ "u section #ahje ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acie;b-#f7 %all1 us+ quantitative & qualitative rese>* me?ods1 provide in=mation to ! committees ( jurisdiction ( ! ,h\se ( ,repres5tatives & ! ,s5ate t id5tifies-- 7#a7 ! teleheal? s]vices = :i* paym5t c be made1 z ( ! date ( ! enactm5t ( ?is ,act1 "u ! fee-=-s]vice program "u p>ts ,a & ,b ( title ,,xviii ( su* ,act2 7#b7 ! teleheal? s]vices = :i* paym5t c be made1 z ( su* date1 "u private heal? insurance plans2 7#c7 ) respect to s]vices id5tifi$ "u p>agraph 7#b7 b n "u p>agraph 7#a71 ways 9 :i* paym5t = su* s]vices might be incorporat$ into su* fee-=-s]vice program 7includ+ any recomm5dations = ways to accompli% ?is incorporation74 7c7 ,s5se ( ,congress ,x is ! s5se ( ,congress t-- 7#a7 eligible orig9at+ sites %\ld be exp&$ beyond ^? orig9at+ sites describ$ 9 section #ahcd7m77#d77;,c7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciem7m77#d77;,c772 & 7#b7 any expansion ( teleheal? s]vices "u ! ,m$ic>e ,program %\ld-- 7,a7 recognize t telem$ic9e is ! deliv]y ( safe1 effective1 quality heal? c>e s]vices1 by a heal? c>e provid]1 us+ te*nology z ! mode ( c>e deliv]y2 7,b7 meet or exce$ ! conditions ( cov]age & paym5t ) respect to ! ,m$ic>e ,program "u title ,,xviii unless specifically address 9 subsequ5t /atute1 ( su* ,act if ! s]vice 7 furni%$ 9 p]son1 includ+ /&>ds ( c>e2 & 7,c7 involve cl9ically appropriate means to furni% su* s]vices4 ,c ,enc\rag+ ,cont9u+ ,m$ical ,education = ,physicians #cjda4 ,exempt+ f manufactur] transp>5cy report+ c]ta9 transf]s us$ = educational purposes 7a7 ,9 g5]al ,section #aabh;,g7e77#aj77;,b7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acbj;a-#g;h7e77#aj77;,b77 is am5d$-- 7#a7 9 clause 7iii71 by ins]t+ 1 includ+ pe]-review$ j\rnals1 j\rnal repr9ts1 j\rnal supplem5ts1 m$ical conf]5ce reports1 & m$ical textbooks aft] pati5t use2 & 7#b7 by add+ at ! end ! foll[+ new clause3 7xiii7 ,9 ! case ( a cov]$ recipi5t :o is a physician1 an indirect paym5t or transf] ( value to ! cov]$ recipi5t-- 7,i7 = speak+ at1 or prep>+ educational mat]ials =1 an educational ev5t = physicians or o!r heal? c>e pr(essionals t does n comm]cially promote a cov]$ drug1 device1 biological1 or m$ical supply2 or 7,,ii7 t s]ves ! sole purpose ( provid+ ! cov]$ recipi5t ) m$ical education1 su* z by provid+ ! cov]$ recipi5t ) ! tuition requir$ to att5d an educational ev5t or ) mat]ials provid$ to physicians at an educational ev5t4 4 7b7 ,effective date ,! am5dm5ts made by ?is section %all apply ) respect to transf]s ( value made on or aft] ! date ( ! enactm5t ( ?is ,act4 ,d ,disposable ,m$ical ,te*nologies #cjfa4 ,treatm5t ( c]ta9 items & devices 7a7 ,9 g5]al ,section #ahcd ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciem7 is am5d$ by add+ at ! end ! foll[+ new subsection3 7r7 ,paym5t = c]ta9 disposable devices 7#a7 ,9 g5]al ,! ,secret>y %all make sep>ate paym5t 9 ! am\nt e/abli%$ "u p>agraph 7#c7 to a home heal? ag5cy = a device describ$ 9 p>agraph 7#b7 :5 furni%$ to an individual :o receives home heal? s]vices = :i* paym5t is made "u section #ahie7;b74 7#b7 ,device describ$ ,= purposes ( p>agraph 7#a71 a device describ$ 9 ?is p>agraph is a disposable device = :i*1 z ( ,janu>y #a1 #bjae1 !re is-- 7,a7 a ,level ,i ,heal?c>e ,common ,proc$ure ,cod+ ,sy/em 7,,hcpcs7 code = :i* ! description = a pr(essional s]vice includes ! furni%+ ( su* device2 & 7,b7 a sep>ate ,level ,i ,,hcpcs code = a pr(essional s]vice t uses durable m$ical equipm5t in/ead ( su* device4 7#c7 ,paym5t am\nt ,! ,secret>y %all e/abli% ! sep>ate paym5t am\nt = su* a device su* t su* am\nt does n exce$ ! paym5t t w\ld be made = ! ,,hcpcs code describ$ 9 p>agraph 7#b77;,a7 "u section #ahcc7t7 7relat+ to paym5t = cov]$ ,,opd s]vices74 4 7b7 ,con=m+ am5dm5t ,section #ahfa7m77#e7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciex7m77#e77 is am5d$ by ins]t+ & devices describ$ 9 section #ahcd7r77#b7 aft] durable m$ical equipm5t4 7c7 ,effective date ,! am5dm5ts made by ?is section %all apply to devices furni%$ on or aft] ,janu>y #a1 #bjag4 ,e ,local cov]age decision re=ms #cjha4 ,improvem5ts 9 ! ,m$ic>e local cov]age det]m9ation 7,,lcd7 process 7a7 ,9 g5]al ,section #ahfb7l77#e7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciey7l77#e77 is am5d$ by add+ at ! end ! foll[+ new subp>agraph3 7,d7 ,local cov]age det]m9ations ,! ,secret>y %all require ea* ,m$ic>e adm9i/rative contractor t develops a local cov]age det]m9ation to make available on ! website ( su* contractor & on ! ,m$ic>e website1 at lea/ #de days be=e ! effective date ( su* det]m9ation1 ! foll[+ in=mation3 7i7 ,su* det]m9ation 9 its entirety4 7ii7 ,:]e & :5 ! propos$ det]m9ation 0 fir/ made public4 7iii7 ,hyp]l9ks to ! propos$ det]m9ation & a response to comm5ts submitt$ to ! contractor ) respect to su* propos$ det]m9ation4 7iv7 ,a summ>y ( evid5ce t 0 consid]$ by ! contractor dur+ ! developm5t ( su* det]m9ation & a li/ ( ! s\rces ( su* evid5ce4 7v7 ,an explanation ( ! rationale t supports su* det]m9ation4 4 7b7 ,effective date ,! am5dm5t made by subsection 7a7 %all apply ) respect to local cov]age det]m9ations t are propos$ or revis$ on or aft] ! date t is #ahj days aft] ! date ( ! enactm5t ( ?is ,act4 ,f ,m$ic>e ,ph>maceutical & ,te*nology ,ombudsman #caja4 ,m$ic>e ph>maceutical & te*nology ombudsman ,section #ahjh7;c7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acie;b-#i7;c77 is am5d$ by add+ at ! end ! foll[+ new p>agraph3 7#d7 ,ph>maceutical & te*nology ombudsman ,n lat] ?an #ab mon?s aft] ! date ( ! enactm5t ( ?is p>agraph1 ! ,secret>y %all provide = a ph>maceutical & te*nology ombudsman )9 ! ,c5t]s = ,m$ic>e ,m$icaid ,s]vices :o %all receive & respond to compla9ts1 grievances1 & reque/s t-- 7,a7 are f entities t manufacture ph>maceutical1 biote*nology1 m$ical device1 or diagno/ic products t are cov]$ or = :i* cov]age is be+ s\ght "u ?is title2 & 7,b7 are ) respect to cov]age1 cod+1 or paym5t "u ?is title = su* products4 ,! second s5t5ce ( p>agraph 7#b7 %all apply to ?is p>agraph 9 ! same mann] z su* s5t5ce applies to p>agraph 7#b74 4 ,g ,m$ic>e site-(-,s]vice price transp>5cy #caba4 ,m$ic>e site-(-,s]vice price transp>5cy ,section #ahcd ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciem71 z am5d$ by section #cjfa1 is fur!r am5d$ by add+ at ! end ! foll[+ new subsection3 7s7 ,site-(-,s]vice price transp>5cy 7#a7 ,9 g5]al ,9 ord] to facilitate price transp>5cy ) respect to items & s]vices = :i* paym5t may be made ei!r to a hospital outpati5t dep>tm5t or to an ambulatory surgical c5t] "u ?is title1 ! ,secret>y %all1 = #bjag & ea* ye> !reaft]1 make available to ! public via a se>*able website1 ) respect to an appropriate numb] ( su* items & s]vices-- 7,a7 ! e/imat$ paym5t am\nt = ! item or s]vice "u ! outpati5t dep>tm5t fee s*$ule "u subsection 7t7 ( section #ahcc & ! ambulatory surgical c5t] paym5t sy/em "u subsection 7i7 ( su* section2 & 7,b7 ! e/imat$ am\nt ( b5efici>y liability applicable to ! item or s]vice4 7#b7 ,calculation ( e/imat$ b5efici>y liability ,= purposes ( p>agraph 7#a77;,b71 ! e/imat$ am\nt ( b5efici>y liability1 ) respect to an item or s]vice1 is ! am\nt = su* item or s]vice = :i* an individual :o does n h cov]age "u a ,m$ic>e supplem5tal policy c]tifi$ "u section #ahhb or any o!r supplem5tal insurance cov]age is responsible4 7#c7 ,implem5tation ,9 c>ry+ out ?is subsection1 ! ,secret>y-- 7,a7 %all include 9 ! notice describ$ 9 section #ahjd7;a7 a notification ( ! availability ( ! e/imat$ am\nts made available "u p>agraph 7#a72 & 7,b7 may utilize me*anisms 9 exi/5ce on ! date ( ! enactm5t ( ?is subsection1 su* z ! portion ( ! website ( ! ,c5t]s = ,m$ic>e ,m$icaid ,s]vices on :i* in=mation comp>+ physician p]=mance is po/$ 7commonly ref]r$ to z ! ,physician ,comp>e website71 to make available su* e/imat$ am\nts "u su* p>agraph4 7#d7 ,fund+ ,= purposes ( implem5t+ ?is subsection1 ! ,secret>y %all provide = ! transf]1 f ! ,supplem5tal ,m$ical ,insurance ,tru/ ,fund "u section #ahda to ! ,c5t]s = ,m$ic>e ,m$icaid ,s]vices ,program ,managem5t ,acc\nt1 ( #f1jjj1jjj = fiscal ye> #bjae1 to rema9 available until exp5d$4 4 ,h ,m$ic>e ,"p ,d ,pati5t ,safety & ,drug ,abuse ,prev5tion #cada4 ,programs to prev5t prescription drug abuse "u ,m$ic>e p>ts ,c & ,d 7a7 ,drug managem5t program = at-,risk b5efici>ies 7#a7 ,9 g5]al ,section #ahfj;,d-#d7;c7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#aj7;c77 is am5d$ by add+ at ! end ! foll[+3 7#e7 ,drug managem5t program = at-risk b5efici>ies 7,a7 ,au?ority to e/abli% ,a ,,pdp sponsor may e/abli% a drug managem5t program = at-risk b5efici>ies "u :i*1 subject to subp>agraph 7,b71 ! ,,pdp sponsor may1 9 ! case ( an at-risk b5efici>y = prescription drug abuse :o is an enrollee 9 a prescription drug plan ( su* ,,pdp sponsor1 limit su* b5efici>y's access to cov]age = frequ5tly abus$ drugs "u su* plan to frequ5tly abus$ drugs t are prescrib$ = su* b5efici>y by "o or m prescrib]s select$ "u subp>agraph 7,d71 & disp5s$ = su* b5efici>y by "o or m ph>macies select$ "u su* subp>agraph4 7,b7 ,requirem5t = notices 7i7 ,9 g5]al ,a ,,pdp sponsor may n limit ! access ( an at-risk b5efici>y = prescription drug abuse to cov]age = frequ5tly abus$ drugs "u a prescription drug plan until su* sponsor-- 7,i7 provides to ! b5efici>y an initial notice describ$ 9 clause 7ii7 & a second notice describ$ 9 clause 7iii72 & 7,,ii7 v]ifies ) ! provid]s ( ! b5efici>y t ! b5efici>y is an at-risk b5efici>y = prescription drug abuse4 7ii7 ,initial notice ,an initial notice describ$ 9 ?is clause is a notice t provides to ! b5efici>y-- 7,i7 notice t ! ,,pdp sponsor has id5tifi$ ! b5efici>y z pot5tially be+ an at-risk b5efici>y = prescription drug abuse2 7,,ii7 in=mation describ+ all ,/ate & ,f$]al public heal? res\rces t are design$ to address prescription drug abuse to :i* ! b5efici>y has access1 includ+ m5tal heal? s]vices & o!r c\nsel+ s]vices2 7,,iii7 notice (1 & in=mation ab\t1 ! "r ( ! b5efici>y to appeal su* id5tification "u subsection 7h7 & ! option ( an automatic escalation to ext]nal review2 7,,iv7 a reque/ = ! b5efici>y to submit to ! ,,pdp sponsor pref]5ces = :i* prescrib]s & ph>macies ! b5efici>y w\ld pref] ! ,,pdp sponsor to select "u subp>agraph 7,d7 9 ! case t ! b5efici>y is id5tifi$ z an at-risk b5efici>y = prescription drug abuse z describ$ 9 clause 7iii77,i72 7,v7 an explanation ( ! mean+ & consequ5ces ( ! id5tification ( ! b5efici>y z pot5tially be+ an at-risk b5efici>y = prescription drug abuse1 includ+ an explanation ( ! drug managem5t program e/abli%$ by ! ,,pdp sponsor pursuant to subp>agraph 7,a72 7,,vi7 cle> in/ructions t expla9 h[ ! b5efici>y c contact ! ,,pdp sponsor 9 ord] to submit to ! ,,pdp sponsor ! pref]5ces describ$ 9 subclause 7,,iv7 & any o!r communications relat+ to ! drug managem5t program = at-risk b5efici>ies e/abli%$ by ! ,,pdp sponsor2 & 7,,vii7 contact in=mation = o!r organizations t c provide ! b5efici>y ) assi/ance reg>d+ su* drug managem5t program 7simil> to ! in=mation provid$ by ! ,secret>y 9 o!r /&>diz$ notices provid$ to "p ,d eligible individuals enroll$ 9 prescription drug plans "u ?is "p74 7iii7 ,second notice ,a second notice describ$ 9 ?is clause is a notice t provides to ! b5efici>y notice-- 7,i7 t ! ,,pdp sponsor has id5tifi$ ! b5efici>y z an at-risk b5efici>y = prescription drug abuse2 7,,ii7 t su* b5efici>y is subject to ! requirem5ts ( ! drug managem5t program = at-risk b5efici>ies e/abli%$ by su* ,,pdp sponsor = su* plan2 7,,iii7 ( ! prescrib] 7or prescrib]s7 & ph>macy 7or ph>macies7 select$ = su* individual "u subp>agraph 7,d72 7,,iv7 (1 & in=mation ab\t1 ! b5efici>y's "r to appeal su* id5tification "u subsection 7h7 & ! option ( an automatic escalation to ext]nal review2 7,v7 t ! b5efici>y c1 9 ! case t ! b5efici>y has n previ\sly submitt$ to ! ,,pdp sponsor pref]5ces = :i* prescrib]s & ph>macies ! b5efici>y w\ld pref] ! ,,pdp sponsor select "u subp>agraph 7,d71 submit su* pref]5ces to ! ,,pdp sponsor2 & 7,,vi7 t includes cle> in/ructions t expla9 h[ ! b5efici>y c contact ! ,,pdp sponsor4 7iv7 ,tim+ ( notices 7,i7 ,9 g5]al ,subject to subclause 7,,ii71 a second notice describ$ 9 clause 7iii7 %all be provid$ to ! b5efici>y on a date t is n less ?an #fj days aft] an initial notice describ$ 9 clause 7ii7 is provid$ to ! b5efici>y4 7,,ii7 ,exception ,9 ! case t ! ,,pdp sponsor1 9 conjunction ) ! ,secret>y1 det]m9es t conc]ns id5tifi$ ?r\gh rulemak+ by ! ,secret>y reg>d+ ! heal? or safety ( ! b5efici>y or reg>d+ significant drug div]sion activities require ! ,,pdp sponsor to provide a second notice describ$ 9 clause 7iii7 to ! b5efici>y on a date t is e>li] ?an ! date describ$ 9 subclause 7,i71 ! ,,pdp sponsor may provide su* second notice on su* e>li] date4 7,c7 ,at-risk b5efici>y = prescription drug abuse 7i7 ,9 g5]al ,= purposes ( ?is p>agraph1 ! t]m at-risk b5efici>y = prescription drug abuse means a "p ,d eligible individual :o is n an exempt$ individual describ$ 9 clause 7ii7 &-- 7,i7 :o is id5tifi$ z su* an at-risk b5efici>y ?r\gh ! use ( cl9ical guidel9es develop$ by ! ,secret>y 9 consultation ) ,,pdp sponsors & o!r /akehold]s describ$ 9 section #cada7;f77#b77;,a7 ( ! #ba/ ,c5tury ,cures ,act2 or 7,,ii7 ) respect to :om ! ,,pdp sponsor ( a prescription drug plan1 ^u enroll+ su* individual 9 su* plan1 receiv$ notice f ! ,secret>y t su* individual 0 id5tifi$ "u ?is p>agraph to be an at-risk b5efici>y = prescription drug abuse "u ! prescription drug plan 9 :i* su* individual 0 mo/ rec5tly previ\sly enroll$ & su* id5tification has n be5 t]m9at$ "u subp>agraph 7,f74 7ii7 ,exempt$ individual describ$ ,an exempt$ individual describ$ 9 ?is clause is an individual :o-- 7,i7 receives hospice c>e "u ?is title2 7,,ii7 is a resid5t ( a long-t]m c>e facility1 ( an int]m$iate c>e facility = ! m5tally ret>d$1 or ( ano!r facility = :i* frequ5tly abus$ drugs are disp5s$ = resid5ts ?r\gh a contract ) a s+le ph>macy2 or 7,,iii7 ! ,secret>y elects to treat z an exempt$ individual = purposes ( clause 7i74 7,d7 ,selection ( prescrib]s & ph>macies 7i7 ,9 g5]al ,) respect to ea* at-risk b5efici>y = prescription drug abuse enroll$ 9 a prescription drug plan (f]$ by su* sponsor1 a ,,pdp sponsor %all1 bas$ on ! pref]5ces submitt$ to ! ,,pdp sponsor by ! b5efici>y pursuant to clauses 7ii77,,iv7 & 7iii77,v7 ( subp>agraph 7,b7 7except z o!rwise provid$ 9 ?is subp>agraph71 select-- 7,i7 "o or m individuals :o are au?oriz$ to prescribe frequ5tly abus$ drugs 7ref]r$ to 9 ?is p>agraph z prescrib]s7 :o may write prescriptions = su* drugs = su* b5efici>y2 & 7,,ii7 "o or m ph>macies t may disp5se su* drugs to su* b5efici>y4 7ii7 ,reasonable access ,9 mak+ ! selections "u ?is subp>agraph-- 7,i7 a ,,pdp sponsor %all ensure t ! b5efici>y cont9ues to h reasonable access to frequ5tly abus$ drugs 7z def9$ 9 subp>agraph 7,g771 tak+ into acc\nt geographic location1 b5efici>y pref]5ce1 impact on co/%>+1 & reasonable travel "t2 & 7,,ii7 a ,,pdp sponsor %all ensure su* access 7includ+ access to prescrib]s & ph>macies ) respect to frequ5tly abus$ drugs7 9 ! case ( individuals ) multiple resid5ces & 9 ! case ( natural disa/]s & simil> em]g5cy situations4 7iii7 ,b5efici>y pref]5ces ,if an at-risk b5efici>y = prescription drug abuse submits pref]5ces = :i* 9-network prescrib]s & ph>macies ! b5efici>y w\ld pref] ! ,,pdp sponsor select 9 response to a notice "u subp>agraph 7,b71 ! ,,pdp sponsor %all-- 7,i7 review su* pref]5ces2 7,,ii7 select or *ange ! selection ( prescrib]s & ph>macies = ! b5efici>y bas$ on su* pref]5ces2 & 7,,iii7 in=m ! b5efici>y ( su* selection or *ange ( selection4 7iv7 ,exception reg>d+ b5efici>y pref]5ces ,9 ! case t ! ,,pdp sponsor det]m9es t a *ange to ! selection ( prescrib] or ph>macy "u clause 7iii77,,ii7 by ! ,,pdp sponsor is contribut+ or w\ld contribute to prescription drug abuse or drug div]sion by ! b5efici>y1 ! ,,pdp sponsor may *ange ! selection ( prescrib] or ph>macy = ! b5efici>y )\t reg>d to ! pref]5ces ( ! b5efici>y describ$ 9 clause 7iii74 7v7 ,confirmation ,be=e select+ a prescrib] 7or prescrib]s7 or ph>macy 7or ph>macies7 "u ?is subp>agraph1 a ,,pdp sponsor mu/ reque/ & receive confirmation f su* a prescrib] or ph>macy ackn[l$g+ & accept+ t ! b5efici>y involv$ is 9 ! drug managem5t program = at-risk b5efici>ies4 7,e7 ,t]m9ations & appeals ,! id5tification ( an individual z an at-risk b5efici>y = prescription drug abuse "u ?is p>agraph1 a cov]age det]m9ation made "u a drug managem5t program = at-risk b5efici>ies1 & ! selection ( prescrib] or ph>macy "u subp>agraph 7,d7 ) respect to su* individual %all be subject to reconsid]ation & appeal "u subsection 7h7 & ! option ( an automatic escalation to ext]nal review to ! ext5t provid$ by ! ,secret>y4 7,f7 ,t]m9ation ( id5tification 7i7 ,9 g5]al ,! ,secret>y %all develop /&>ds = ! t]m9ation ( id5tification ( an individual z an at-risk b5efici>y = prescription drug abuse "u ?is p>agraph4 ,"u su* /&>ds su* id5tification %all t]m9ate z ( ! e>li] (-- 7,i7 ! date ! individual demon/rates t ! individual is no long] likely1 9 ! abs5ce ( ! re/rictions "u ?is p>agraph1 to be an at-risk b5efici>y = prescription drug abuse describ$ 9 subp>agraph 7,c77i72 & 7,,ii7 ! end ( su* maximum p]iod ( id5tification z ! ,secret>y may specify4 7ii7 ,rule ( con/ruction ,no?+ 9 clause 7i7 %all be con/ru$ z prev5t+ a plan f id5tify+ an individual z an at-risk b5efici>y = prescription drug abuse "u subp>agraph 7,c77i7 aft] su* t]m9ation on ! basis ( additional in=mation on drug use occurr+ aft] ! date ( notice ( su* t]m9ation4 7,g7 ,frequ5tly abus$ drug ,= purposes ( ?is subsection1 ! t]m frequ5tly abus$ drug means a drug t is a controll$ sub/ance t ! ,secret>y det]m9es to be frequ5tly abus$ or div]t$4 7,h7 ,data disclosure ,9 ! case ( an at-risk b5efici>y = prescription drug abuse ^: access to cov]age = frequ5tly abus$ drugs "u a prescription drug plan has be5 limit$ by a ,,pdp sponsor "u ?is p>agraph1 su* ,,pdp sponsor %all disclose data1 includ+ any necess>y individually id5tifiable heal? in=mation1 9 a =m & mann] specifi$ by ! ,secret>y1 ab\t ! decision to impose su* limitations & ! limitations impos$ by ! sponsor "u ?is "p to o!r ,,pdp sponsors t reque/ su* data4 7,i7 ,education ,! ,secret>y %all provide education to enrollees 9 prescription drug plans ( ,,pdp sponsors & provid]s reg>d+ ! drug managem5t program = at-risk b5efici>ies describ$ 9 ?is p>agraph1 includ+ education-- 7i7 provid$ by ,m$ic>e adm9i/rative contractors ?r\gh ! improp] paym5t outrea* & education program describ$ 9 section #ahgd;,a7h72 & 7ii7 ?r\gh curr5t education ef=ts 7su* z ,/ate heal? insurance assi/ance programs describ$ 9 subsection 7a77#a77;,a7 ( section #aai ( ! ,m$ic>e ,improvem5ts = ,pati5ts & ,provid]s ,act ( #bjjh 7#db ,u4,s4,c4 #acie;b-#c note77 & mat]ials direct$ t[>d su* enrollees4 7,j7 ,application "u ,,ma-,,pd plans ,pursuant to section #ahfj;,d-#ba7;c77#a71 ! provisions ( ?is p>agraph apply "u "p ,d to ,,ma organizations (f]+ ,,ma-,,pd plans to ,,ma eligible individuals 9 ! same mann] z su* provisions apply "u ?is "p to a ,,pdp sponsor (f]+ a prescription drug plan to a "p ,d eligible individual4 4 7#b7 ,in=mation = consum]s ,section #ahfj;,d-#d7;a77#a77;,b7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#ajd7;a77#a77;,b77 is am5d$ by add+ at ! end ! foll[+3 7v7 ,! drug managem5t program = at-risk b5efici>ies "u subsection 7c77#e74 4 7b7 ,utilization managem5t programs ,section #ahfj;,d-#d7;c7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#ajd7;c771 z am5d$ by subsection 7a77#a71 is fur!r am5d$-- 7#a7 9 p>agraph 7#a71 by ins]t+ aft] subp>agraph 7,d7 ! foll[+ new subp>agraph3 7,e7 ,a utilization managem5t tool to prev5t drug abuse 7z describ$ 9 p>agraph 7#f77;,a774 2 & 7#b7 by add+ at ! end ! foll[+ new p>agraph3 7#f7 ,utilization managem5t tool to prev5t drug abuse 7,a7 ,9 g5]al ,a tool describ$ 9 ?is p>agraph is any ( ! foll[+3 7i7 ,a utilization tool design$ to prev5t ! abuse ( frequ5tly abus$ drugs by individuals & to prev5t ! div]sion ( su* drugs at ph>macies4 7ii7 ,retrospective utilization review to id5tify-- 7,i7 individuals t receive frequ5tly abus$ drugs at a frequ5cy or 9 am\nts t are n cl9ically appropriate2 & 7,,ii7 provid]s ( s]vices or suppli]s t may facilitate ! abuse or div]sion ( frequ5tly abus$ drugs by b5efici>ies4 7iii7 ,consultation ) ! contractor describ$ 9 subp>agraph 7,b7 to v]ify if an individual enroll+ 9 a prescription drug plan (f]$ by a ,,pdp sponsor has be5 previ\sly id5tifi$ by ano!r ,,pdp sponsor z an individual describ$ 9 clause 7ii77,i74 7,b7 ,report+ ,a ,,pdp sponsor (f]+ a prescription drug plan 7& an ,,ma organization (f]+ an ,,ma-,,pd plan7 9 a ,/ate %all submit to ! ,secret>y & ! ,m$ic>e drug integrity contractor ) :i* ! ,secret>y has ent]$ into a contract "u section #ahic ) respect to su* ,/ate a report1 on a mon?ly basis1 conta9+ in=mation on-- 7i7 any provid] ( s]vices or suppli] describ$ 9 subp>agraph 7,a77ii77,,ii7 t is id5tifi$ by su* plan sponsor 7or organization7 dur+ ! #cj-;day p]iod be=e su* report is submitt$2 & 7ii7 ! "n & prescription records ( individuals describ$ 9 p>agraph 7#e77;,c74 4 7c7 ,exp&+ ,activities ( ,m$ic>e ,drug ,integrity ,contractors 7,m,e,d,i,cs7 7#a7 ,9 g5]al ,section #ahic ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acie;ddd7 is am5d$ by add+ at ! end ! foll[+ new subsection3 7j7 ,exp&+ ,activities ( ,m$ic>e ,drug ,integrity ,contractors 7,m,e,d,i,cs7 7#a7 ,access to in=mation ,"u contracts ent]$ into "u ?is section ) ,m$ic>e drug integrity contractors 7includ+ any successor entity to a ,m$ic>e drug integrity contractor71 ! ,secret>y %all au?orize su* contractors to directly accept prescription & necess>y m$ical records f entities su* z ph>macies1 prescription drug plans1 ,,ma-,,pd plans1 & physicians ) respect to an individual 9 ord] = su* contractors to provide in=mation relevant to ! det]m9ation ( :e!r su* individual is an at-risk b5efici>y = prescription drug abuse1 z def9$ 9 section #ahfj;,d-#d7;c77#e77;,c74 7#b7 ,requirem5t = ackn[l$gm5t ( ref]rals ,if a ,,pdp sponsor or ,,ma organization ref]s in=mation to a contractor describ$ 9 p>agraph 7#a7 9 ord] = su* contractor to assi/ 9 ! det]m9ation describ$ 9 su* p>agraph1 ! contractor %all-- 7,a7 ackn[l$ge to ! sponsor or organization receipt ( ! ref]ral2 & 7,b7 9 ! case t any ,,pdp sponsor or ,,ma organization contacts ! contractor reque/+ to "k ! det]m9ation by ! contractor ( :e!r or n an individual has be5 det]m9$ to be an individual describ$ su* p>agraph1 %all in=m su* sponsor or organization ( su* det]m9ation on a date t is n lat] ?an #ae days aft] ! date on :i* ! sponsor or organization contacts ! contractor4 7#c7 ,mak+ data available to o!r entities 7,a7 ,9 g5]al ,= purposes ( c>ry+ out ?is subsection1 subject to subp>agraph 7,b71 ! ,secret>y %all au?orize ,m,e,d,i,cs to respond to reque/s = in=mation f ,,pdp sponsors & ,,ma organizations1 ,/ate prescription drug monitor+ programs1 & o!r entities delegat$ by su* sponsors or organizations us+ available programs & sy/ems 9 ! ef=t to prev5t fraud1 wa/e1 & abuse4 7,b7 ,,hipaa compliant in=mation only ,in=mation may only be disclos$ by a ,,m$ic "u subp>agraph 7,a7 if ! disclosure ( su* in=mation is p]mitt$ "u ! ,f$]al regulations 7conc]n+ ! privacy ( individually id5tifiable heal? in=mation7 promulgat$ "u section #bfd7;c7 ( ! ,heal? ,insurance ,portability & ,acc\ntability ,act ( #aiif 7#db ,u4,s4,c4 #acbj;d-#b note74 4 7#b7 ,,oig /udy & report on effectiv5ess ( ,m,e,d,i,cs 7,a7 ,/udy ,! ,inspector ,g5]al ( ! ,dep>tm5t ( ,heal? & ,human ,s]vices %all conduct a /udy on ! effectiv5ess ( ,m$ic>e drug integrity contractors ) :i* ! ,secret>y ( ,heal? & ,human ,s]vices has ent]$ into a contract "u section #ahic ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acie;ddd7 9 id5tify+1 combat+1 & prev5t+ fraud "u ! ,m$ic>e ,program1 includ+ "u ! au?ority provid$ "u section #ahic7;j7 ( ! ,social ,security ,act1 add$ by p>agraph 7#a74 7,b7 ,report ,n lat] ?an #a ye> aft] ! date ( ! enactm5t ( ?is ,act1 ! ,inspector ,g5]al %all submit to ,congress a report on ! /udy conduct$ "u subp>agraph 7,a74 ,su* report %all include su* recomm5dations = improvem5ts 9 ! effectiv5ess ( su* contractors z ! ,inspector ,g5]al det]m9es appropriate4 7d7 ,treatm5t ( c]ta9 compla9ts = purposes ( quality or p]=mance assessm5t ,section #ahfj;,d-#db ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#aeb7 is am5d$ by add+ at ! end ! foll[+ new subsection3 7d7 ,treatm5t ( c]ta9 compla9ts = purposes ( quality or p]=mance assessm5t ,9 conduct+ a quality or p]=mance assessm5t ( a ,,pdp sponsor1 ! ,secret>y %all develop or utilize exi/+ scre5+ me?ods = review+ & consid]+ compla9ts t are receiv$ f enrollees 9 a prescription drug plan (f]$ by su* ,,pdp sponsor & t are compla9ts reg>d+ ! lack ( access by ! individual to prescription drugs due to a drug managem5t program = at-risk b5efici>ies4 4 7e7 ,s5se ( congress reg>d+ use ( te*nology tools ,to combat fraud ,x is ! s5se ( ,congress t ,,ma organizations & ,,pdp sponsors %\ld consid] us+ e-prescrib+ & o!r heal? in=mation te*nology tools to support combat+ fraud "u ,,ma-,,pd plans & prescription drug plans "u p>ts ,c & ,d ( ! ,m$ic>e ,program4 7f7 ,effective date 7#a7 ,9 g5]al ,! am5dm5ts made by ?is section %all apply to prescription drug plans 7& ,,ma-,,pd plans7 = plan ye>s beg9n+ m ?an #a ye> aft] ! date ( ! enactm5t ( ?is ,act4 7#b7 ,/akehold] meet+s prior to effective date 7,a7 ,9 g5]al ,n lat] ?an ,janu>y #a1 #bjaf1 ! ,secret>y ( ,heal? & ,human ,s]vices %all conv5e /akehold]s1 includ+ individuals entitl$ to b5efits "u "p ,a ( title ,,xviii ( ! ,social ,security ,act or enroll$ "u "p ,b ( su* title ( su* ,act1 advocacy gr\ps repres5t+ su* individuals1 physicians1 ph>maci/s1 & o!r cl9icians1 retail ph>macies1 plan sponsors1 entities delegat$ by plan sponsors1 & bioph>maceutical manufactur]s = input reg>d+ ! topics describ$ 9 subp>agraph 7,b74 7,b7 ,topics describ$ ,! topics describ$ 9 ?is subp>agraph are ! topics (-- 7i7 ! anticipat$ impact ( drug managem5t programs = at-risk b5efici>ies "u p>agraph 7#e7 ( section #ahfj;,d-#d7;c7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#ajd7;c77 on co/-%>+ & ensur+ accessibility to prescription drugs = enrollees 9 prescription drug plans ( ,,pdp sponsors1 & enrollees 9 ,,ma-,,pd plans1 :o are at-risk b5efici>ies = prescription drug abuse 7z def9$ 9 subp>agraph 7,c7 ( su* p>agraph72 7ii7 ! use ( an exp$it$ appeals process "u :i* su* an enrollee may appeal an id5tification ( su* enrollee z an at-risk b5efici>y = prescription drug abuse "u su* p>agraph 7simil> to ! processes e/abli%$ "u ! ,m$ic>e ,advantage program "u "p ,c ( title ,,xviii ( ! ,social ,security ,act t all[ an automatic escalation to ext]nal review ( claims submitt$ "u su* "p72 7iii7 ! types ( enrollees t %\ld be treat$ z exempt$ individuals1 z describ$ 9 subp>agraph 7,c77ii7 ( su* p>agraph2 7iv7 ! mann] 9 :i* t]ms & def9itions 9 su* p>agraph %\ld be appli$1 su* z ! use ( cl9ical appropriat5ess 9 det]m9+ :e!r an enrollee is an at-risk b5efici>y = prescription drug abuse z def9$ 9 subp>agraph 7,c7 ( su* p>agraph2 7v7 ! in=mation to be includ$ 9 ! notices describ$ 9 subp>agraph 7,b7 ( su* p>agraph & ! /&>dization ( su* notices2 & 7vi7 ) respect to a ,,pdp sponsor 7or ,m$ic>e ,advantage organization7 t e/abli%es a drug managem5t program = at-risk b5efici>ies "u su* p>agraph1 ! responsibilities ( su* ,,pdp sponsor 7or organization7 ) respect to ! implem5tation ( su* program4 7g7 ,rulemak+ ,! ,secret>y ( ,heal? & ,human ,s]vices %all promulgate regulations bas$ on ! input ga!r$ pursuant to subsection 7f77#b77;,a74 ,,iv ,m$icaid1 ,m$ic>e1 & ,o!r ,re=ms ,a ,m$icaid & ,m$ic>e ,re=ms #djja4 ,limit+ ,f$]al ,m$icaid reimbursem5t to ,/ates = durable m$ical equipm5t 7,,dme7 to ,m$ic>e paym5t rates 7a7 ,m$icaid reimbursem5t 7#a7 ,9 g5]al ,section #aijc7;i7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acif;b7i77 is am5d$-- 7,a7 9 p>agraph 7#be71 by /rik+ or at ! end2 7,b7 9 p>agraph 7#bf71 by /rik+ ! p]iod at ! end & ins]t+ 2 or2 & 7,c7 by ins]t+ aft] p>agraph 7#bf7 ! foll[+ new p>agraph3 7#bg7 ) respect to any am\nts exp5d$ by ! ,/ate on ! basis ( a fee s*$ule = items describ$ 9 section #ahfa7n71 z det]m9$ 9 ! aggregate ) respect to ea* class ( su* items z def9$ by ! ,secret>y1 9 excess ( ! aggregate am\nt1 if any1 t w\ld be paid = su* items )9 su* class on a fee-=-s]vice basis "u ! program "u "p ,b ( title ,,xviii1 includ+1 z applicable1 "u a competitive acquisition program "u section #ahdg 9 an area ( ! ,/ate4 4 7#b7 ,effective date ,! am5dm5ts made by ?is subsection %all be effective ) respect to paym5ts = items furni%$ on or aft] ,janu>y #a1 #bjbj4 7b7 ,m$ic>e ombudsman ,section #ahjh7;c7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acie;b7c771 z am5d$ by section #caja1 is fur!r am5d$ by add+ at ! end ! foll[+ new p>agraph3 7#e7 ,monitor+ ,,dme reimbursem5t "u ,m$icaid ,! ombudsm5 "u ea* ( p>agraphs 7#a7 & 7#d7 %all evaluate ! impact ( ! competitive acquisition program "u section #ahdg1 includ+ z appli$ "u section #aijc7;i77#bg71 on b5efici>y heal? /atus & heal? outcomes4 4 #djjb4 ,exclud+ au?oriz$ g5]ics f calculation ( av]age manufactur] price 7a7 ,9 g5]al ,subp>agraph 7,c7 ( section #aibg7k77#a7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acifr-#h7k77#a77 is am5d$-- 7#a7 9 ! subp>agraph head+1 by /rik+ ,inclusion & ins]t+ ,exclusion2 7#b7 by /rik+ a new drug application & ins]t+ ! manufactur]'s new drug application2 & 7#c7 by /rik+ inclusive & ins]t+ exclusive4 7b7 ,effective date ,! am5dm5ts made by ?is section take effect on ,octob] #a1 #bjae4 #djjc4 ,m$ic>e paym5t inc5tive = ! transition f traditional x-ray imag+ to digital radiography & o!r ,m$ic>e imag+ paym5t provision 7a7 ,physician fee s*$ule 7#a7 ,paym5t inc5tive = transition 7,a7 ,9 g5]al ,section #ahdh7;b7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#d7;b77 is am5d$ by add+ at ! end ! foll[+ new p>agraph3 7#i7 ,special rule to inc5tivize transition f traditional x-ray imag+ to digital radiography 7,a7 ,limitation on paym5t = film x-ray imag+ s]vices ,9 ! case ( an imag+ s]vice 7includ+ ! imag+ portion ( a s]vice7 t is an ,x-ray tak5 us+ film & t is furni%$ dur+ #bjag or a subsequ5t ye>1 ! paym5t am\nt = ! te*nical compon5t 7includ+ ! te*nical compon5t portion ( a global s]vice7 ( su* s]vice t w\ld o!rwise be det]m9$ "u ?is section 7)\t application ( ?is p>agraph & be=e application ( any o!r adju/m5t "u ?is section7 = su* ye> %all be r$uc$ by #bj p]c5t4 7,b7 ,phas$-9 limitation on paym5t = comput$ radiography imag+ s]vices ,9 ! case ( an imag+ s]vice 7includ+ ! imag+ portion ( a s]vice7 t is an ,x-ray tak5 us+ comput$ radiography te*nology-- 7i7 9 ! case ( su* a s]vice furni%$ dur+ #bjah1 #bjai1 #bjbj1 #bjba1 or #bjbb1 ! paym5t am\nt = ! te*nical compon5t 7includ+ ! te*nical compon5t portion ( a global s]vice7 ( su* s]vice t w\ld o!rwise be det]m9$ "u ?is section 7)\t application ( ?is p>agraph & be=e application ( any o!r adju/m5t "u ?is section7 = su* ye> %all be r$uc$ by #g p]c5t2 & 7ii7 9 ! case ( su* a s]vice furni%$ dur+ #bjbc or a subsequ5t ye>1 ! paym5t am\nt = ! te*nical compon5t 7includ+ ! te*nical compon5t portion ( a global s]vice7 ( su* s]vice t w\ld o!rwise be det]m9$ "u ?is section 7)\t application ( ?is p>agraph & be=e application ( any o!r adju/m5t "u ?is section7 = su* ye> %all be r$uc$ by #aj p]c5t4 7,c7 ,comput$ radiography te*nology def9$ ,= purposes ( ?is p>agraph1 ! t]m comput$ radiography te*nology means cassette-bas$ imag+ :i* utilizes an imag+ plate to create ! image involv$4 7,d7 ,implem5tation ,9 ord] to implem5t ?is p>agraph1 ! ,secret>y %all adopt appropriate me*anisms :i* may include use ( modifi]s4 4 7,b7 ,exemption f budget neutrality ,section #ahdh7;c77#b77;,b77v7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#d7;c77#b77;,b77v77 is am5d$ by add+ at ! end ! foll[+ new subclause3 7,x7 ,r$uc$ exp5ditures attributable to inc5tives to transition to digital radiography ,effective = fee s*$ules e/abli%$ beg9n+ ) #bjag1 r$uc$ exp5ditures attributable to subp>agraph 7,a7 ( subsection 7b77#i7 & effective = fee s*$ules e/abli%$ beg9n+ ) #bjah1 r$uc$ exp5ditures attributable to subp>agraph 7,b7 ( su* subsection4 4 7#b7 ,elim9ation ( application ( multiple proc$ure paym5t r$uction 7,a7 ,9 g5]al ,section #ahdh7;b77#d7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#d7;b77#d77 is am5d$ by add+ at ! end ! foll[+ new subp>agraph3 7,e7 ,elim9ation ( application ( multiple proc$ure paym5t r$uction 7i7 ,9 g5]al ,= s]vices furni%$ on or aft] ,janu>y #a1 #bjag1 ! ,secret>y %all n apply a multiple proc$ure paym5t r$uction to ! pr(essional compon5t ( imag+ s]vices unless ! ,secret>y has publi%$ z "p ( a ,m$ic>e ,physician ,fee ,s*$ule ,propos$ ,rule ! empirical analysis describ$ 9 clause 7ii7 ) tables made available on ! website ( ! ,c5t]s = ,m$ic>e ,m$icaid ,s]vices4 7ii7 ,empirical analysis describ$ ,! empirical analysis describ$ 9 ?is clause is an analysis ( ! ,res\rce-,bas$ ,relative ,value ,scale ,data ,manag] in=mation or o!r in=mation t is us$ to det]m9e :at1 if any1 effici5cies exi/ )9 ! pr(essional compon5t ( imag+ s]vices :5 two or m /udies are furni%$ to ! same individual on ! same day4 ,su* empirical analysis %all include-- 7,i7 in=mation detail+ :i* physician "w activities ov]lap & ! r$uctions applicable to su* ov]lap2 7,,ii7 a discussion ( ! cl9ical aspects t in=m$ ! assignm5t ( ! r$uction p]c5tages describ$ 9 subclause 7,i72 7,,iii7 to ! ext5t t su* r$uctions are us$ = propos$ paym5t r$uctions1 an explanation ( h[ ! p]c5tage r$uctions = pre-s]vice1 intra-s]vice1 & po/-s]vice "w 7 det]m9$ & calculat$2 7,,iv7 o!r data us$ to det]m9e a r$uction2 & 7,v7 a demon/ration t ! ,secret>y has consult$ ) practic+ radiologi/s to ga9 k ( h[ radiologi/s int]pret /udies ( multiple body p>ts on ! same individual on ! same day4 4 7,b7 ,con=m+ am5dm5t ,section #bbj7;i7 ( ! ,protect+ ,access to ,m$ic>e ,act ( #bjad 7#db ,u4,s4,c4 #aciew-#d note7 is repeal$4 7b7 ,paym5t inc5tive = transition "u hospital outpati5t prospective paym5t sy/em ,section #ahcc7t77#af7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acie7t77#af77 is am5d$ by add+ at ! end ! foll[+ new subp>agraph3 7,f7 ,paym5t inc5tive = ! transition f traditional x-ray imag+ to digital radiography ,not)/&+ ! previ\s provisions ( ?is subsection3 7i7 ,limitation on paym5t = film x-ray imag+ s]vices ,9 ! case ( an imag+ s]vice t is an ,x-ray tak5 us+ film & t is furni%$ dur+ #bjag or a subsequ5t ye>1 ! paym5t am\nt = su* s]vice 7includ+ ! ,x-ray compon5t ( a packag$ s]vice7 t w\ld o!rwise be det]m9$ "u ?is section 7)\t application ( ?is p>agraph & be=e application ( any o!r adju/m5t "u ?is subsection7 = su* ye> %all be r$uc$ by #bj p]c5t4 7ii7 ,phas$-9 limitation on paym5t = comput$ radiography imag+ s]vices ,9 ! case ( an imag+ s]vice t is an ,x-ray tak5 us+ comput$ radiography te*nology 7z def9$ 9 section #ahdh7;b77#i77;,c77-- 7,i7 9 ! case ( su* a s]vice furni%$ dur+ #bjah1 #bjai1 #bjbj1 #bjba1 or #bjbb1 ! paym5t am\nt = su* s]vice 7includ+ ! ,x-ray compon5t ( a packag$ s]vice7 t w\ld o!rwise be det]m9$ "u ?is section 7)\t application ( ?is p>agraph & be=e application ( any o!r adju/m5t "u ?is subsection7 = su* ye> %all be r$uc$ by #g p]c5t2 & 7,,ii7 9 ! case ( su* a s]vice furni%$ dur+ #bjbc or a subsequ5t ye>1 ! paym5t am\nt = su* s]vice 7includ+ ! ,x-ray compon5t ( a packag$ s]vice7 t w\ld o!rwise be det]m9$ "u ?is section 7)\t application ( ?is p>agraph & be=e application ( any o!r adju/m5t "u ?is subsection7 = su* ye> %all be r$uc$ by #aj p]c5t4 7iii7 ,application )\t reg>d to budget neutrality ,! r$uctions made "u ?is p>agraph-- 7,i7 %all n be consid]$ an adju/m5t "u p>agraph 7#b77;,e72 & 7,,ii7 %all n be implem5t$ 9 a budget neutral mann]4 7iv7 ,implem5tation ,9 ord] to implem5t ?is subp>agraph1 ! ,secret>y %all adopt appropriate me*anisms :i* may include use ( modifi]s4 4 #djjd4 ,treatm5t ( infusion drugs furni%$ ?r\gh durable m$ical equipm5t ,section #ahdb7o77#a7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acieu7o77#a77 is am5d$-- 7#a7 9 subp>agraph 7,c71 by ins]t+ 7& includ+ a drug or biological describ$ 9 subp>agraph 7,d77i7 furni%$ on or aft] ,janu>y #a1 #bjag7 aft] #bjje2 & 7#b7 9 subp>agraph 7,d7-- 7,a7 by /rik+ infusion drugs & ins]t+ infusion drugs or biologicals ea* place x appe>s2 & 7,b7 9 clause 7i7-- 7i7 by /rik+ #bjjd & ins]t+ #bjjd1 & be=e ,janu>y #a1 #bjag2 & 7ii7 by /rik+ = su* drug4 #djje4 ,ext5sion & expansion ( prior au?orization = p[] mobility devices 7,p,m,ds7 & accessories & prior au?orization audit limitations ,section #ahcd7;a7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciem7a77 is am5d$-- 7#a7 9 p>agraph 7#ae71 by add+ at ! end ! foll[+ new subp>agraph3 7,d7 ,limitation on audits aft] advance det]m9ation ,a claim = an item t has receiv$ a provisional affirmation "u an advance det]m9ation "u ?is p>agraph or a prior au?orization "u p>agraph 7#bc7 %all n be subject to review "u section #ahic7;h7 b may be subject to audits = pot5tial fraud1 inappropriate utilization1 *anges 9 bill+ patt]ns1 or in=mation t c\ld n h be5 consid]$ dur+ ! advance det]m9ation 7su* z pro( ( item deliv]y74 2 & 7#b7 by add+ at ! end ! foll[+ new p>agraph3 7#bc7 ,prior au?orization = p[] mobility devices 7,p,m,ds7 & accessories ,n lat] ?an #ij days aft] ! date ( ! enactm5t ( ?is p>agraph1 ! ,secret>y %all1 us+ funds provid$ "u p>agraph 7#b7 ( section #djb7;a7 ( ! ,social ,security ,am5dm5ts ( #aifg & o!r funds available to ! ,secret>y-- 7,a7 ext5d at lea/ ?r\gh ,augu/ #ca1 #bjah1 ! ,,pmd ,prior ,au?orization ,demon/ration 7be+ conduct$ "u p>agraph 7#a77;,j7 ( su* section72 7,b7 beg9 to exp&1 z appropriate1 su* demon/ration to include additional p[] mobility devices & accessories z "p ( initial claims = paym5t "u ?is "p = su* devices2 & 7,c7 beg9 to exp& su* demon/ration to su* additional ,/ates or geographic areas z may be appropriate4 4 #djjf4 ,civil monet>y p5alties = violations relat$ to grants1 contracts1 & o!r agreem5ts 7a7 ,9 g5]al ,section #aabh;,a ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acbj;a-#g;a7 is am5d$ by add+ at ! end ! foll[+ new subsection3 7o7 ,any p]son 7includ+ an organization1 ag5cy1 or o!r entity1 b exclud+ a program b5efici>y1 z def9$ 9 subsection 7r77#d77 t1 ) respect to a grant1 contract1 or o!r agreem5t = :i* ! ,secret>y ( ,heal? & ,human ,s]vices provides fund+-- 7#a7 kn[+ly pres5ts or causes to be pres5t$ a specifi$ claim 7z def9$ 9 subsection 7r77#f77 "u su* grant1 contract1 or o!r agreem5t t ! p]son kn[s or %\ld "k is false or fraudul5t2 7#b7 kn[+ly makes1 uses1 or causes to be made or us$ any false /atem5t1 omission1 or misrepres5tation ( a mat]ial fact 9 any application1 proposal1 bid1 progress report1 or o!r docum5t t is requir$ to be submitt$ 9 ord] to directly or indirectly receive or reta9 funds provid$ 9 :ole or 9 "p by su* ,secret>y pursuant to su* grant1 contract1 or o!r agreem5t2 7#c7 kn[+ly makes1 uses1 or causes to be made or us$1 a false record or /atem5t mat]ial to a false or fraudul5t specifi$ claim "u su* grant1 contract1 or o!r agreem5t2 7#d7 kn[+ly makes1 uses1 or causes to be made or us$1 a false record or /atem5t mat]ial to an obligation to pay or transmit funds or prop]ty to su* ,secret>y ) respect to su* grant1 contract1 or o!r agreem5t1 or kn[+ly conceals or kn[+ly & improp]ly avoids or decreases an obligation to pay or transmit funds or prop]ty to su* ,secret>y ) respect to su* grant1 contract1 or o!r agreem5t2 or 7#e7 fails to grant timely access1 ^u reasonable reque/ 7z def9$ by su* ,secret>y 9 regulations71 to ! ,inspector ,g5]al ( ! ,dep>tm5t1 = ! purpose ( audits1 inve/igations1 evaluations1 or o!r /atutory functions ( su* ,inspector ,g5]al 9 matt]s involv+ su* grants1 contracts1 or o!r agreem5ts2 %all be subject1 9 addition to any o!r p5alties t may be prescrib$ by law1 to a civil money p5alty 9 cases "u p>agraph 7#a71 ( n m ?an #aj1jjj = ea* specifi$ claim2 9 cases "u p>agraph 7#b71 n m ?an #ej1jjj = ea* false /atem5t1 omission1 or misrepres5tation ( a mat]ial fact2 9 cases "u p>agraph 7#c71 n m ?an #ej1jjj = ea* false record or /atem5t2 9 cases "u p>agraph 7#d71 n m ?an #ej1jjj = ea* false record or /atem5t or #aj1jjj = ea* day t ! p]son kn[+ly conceals or kn[+ly & improp]ly avoids or decreases an obligation to pay2 or 9 cases "u p>agraph 7#e71 n m ?an #ae1jjj = ea* day ( ! failure describ$ 9 su* p>agraph4 ,9 addition1 9 cases "u p>agraphs 7#a7 & 7#c71 su* a p]son %all be subject to an assessm5t ( n m ?an #c times ! am\nt claim$ 9 ! specifi$ claim describ$ 9 su* p>agraph 9 lieu ( damages su/a9$ by ! ,unit$ ,/ates or a specifi$ ,/ate ag5cy because ( su* specifi$ claim1 & 9 cases "u p>agraphs 7#b7 & 7#d71 su* a p]son %all be subject to an assessm5t ( n m ?an #c times ! total am\nt ( ! funds describ$ 9 p>agraph 7#b7 or 7#d71 respectively 7or1 9 ! case ( an obligation to transmit prop]ty to ! ,secret>y ,heal? & ,human ,s]vices describ$ 9 p>agraph 7#d71 ( ! value ( ! prop]ty describ$ 9 su* p>agraph7 9 lieu ( damages su/a9$ by ! ,unit$ ,/ates or a specifi$ ,/ate ag5cy because ( su* case4 ,9 addition1 ! ,secret>y ( ,heal? & ,human ,s]vices may make a det]m9ation 9 ! same proce$+ to exclude ! p]son f p>ticipation 9 ! ,f$]al heal? c>e programs 7z def9$ 9 section #aabh;,b7f77#a77 & to direct ! appropriate ,/ate ag5cy to exclude ! p]son f p>ticipation 9 any ,/ate heal? c>e program4 7p7 ,! provisions ( subsections 7c71 7d71 & 7g7 %all apply to a civil money p5alty or assessm5t "u subsection 7o7 9 ! same mann] z su* provisions apply to a p5alty1 assessm5t1 or proce$+ "u subsection 7a74 7q7 ,) respect to a p5alty or assessm5t "u subsection 7o71 ! ,inspector ,g5]al ( ! ,dep>tm5t is au?oriz$ to receive1 & to reta9 = curr5t use1 su* am\nts ( su* p5alty or assessm5t z are necess>y to provide reimbursem5t = ! co/s ( conduct+ inve/igations & audits ) respect to su* subsection & = monitor+ compliance plans ) respect to su* subsection :5 su* p5alty or assessm5t is ord]$ by a c\rt1 volunt>ily agre$ to by ! payor1 or o!rwise4 ,funds receiv$ by su* ,inspector ,g5]al z reimbursem5t "u ! prec$+ s5t5ce %all be deposit$ to ! cr$it ( ! appropriations f :i* initially paid1 or to appropriations = simil> purposes curr5tly available at ! "t ( deposit1 & %all rema9 available = obligation = #a ye> f ! date ( ! deposit ( su* funds4 7r7 ,= purposes ( ?is subsection & subsections 7o71 7p71 & 7q73 7#a7 ,! t]m ,dep>tm5t means ! ,dep>tm5t ( ,heal? & ,human ,s]vices4 7#b7 ,! t]m mat]ial means hav+ a natural t5d5cy to influ5ce1 or be capable ( influ5c+1 ! paym5t or receipt ( money or prop]ty4 7#c7 ,! t]m o!r agreem5t includes a coop]ative agreem5t1 s*ol>%ip1 fell[%ip1 loan1 subsidy1 paym5t = a specifi$ use1 donation agreem5t1 aw>d1 or sub-aw>d 7reg>dless ( :e!r "o or m ( ! p]sons ent]+ into ! agreem5t is a contractor or sub-contractor74 7#d7 ,! t]m program b5efici>y means1 9 ! case ( a grant1 contract1 or o!r agreem5t design$ to accompli% ! objective ( aw>d+ or o!rwise furni%+ b5efits or assi/ance to individuals & = :i* ! ,secret>y ( ,heal? & ,human ,s]vices provides fund+1 an individual :o applies =1 or :o receives1 su* b5efits or assi/ance f su* grant1 contract1 or o!r agreem5t4 ,su* t]m does n include1 ) respect to su* grant1 contract1 or o!r agreem5t1 an (fic]1 employee1 or ag5t ( a p]son or entity t receives su* grant or t ent]s into su* contract or o!r agreem5t4 7#e7 ,! t]m recipi5t includes a sub-recipi5t or subcontractor4 7#f7 ,! t]m specifi$ claim means any application1 reque/1 or dem& "u a grant1 contract1 or o!r agreem5t = money or prop]ty1 :e!r or n ! ,unit$ ,/ates or a specifi$ ,/ate ag5cy has title to ! money or prop]ty1 t is n a claim 7z def9$ 9 subsection 7i77#b77 & t-- 7,a7 is pres5t$ or caus$ to be pres5t$ to an (fic]1 employee1 or ag5t ( ! ,dep>tm5t or ag5cy !re(1 or ( any specifi$ ,/ate ag5cy2 or 7,b7 is made to a contractor1 grantee1 or any o!r recipi5t if ! money or prop]ty is to be sp5t or us$ on ! ,dep>tm5t's behalf or to advance a ,dep>tm5t program or int]e/1 & if ! ,dep>tm5t-- 7i7 provides or has provid$ any portion ( ! money or prop]ty reque/$ or dem&$2 or 7ii7 w reimburse su* contractor1 grantee or o!r recipi5t = any portion ( ! money or prop]ty :i* is reque/$ or dem&$4 7#g7 ,! t]m specifi$ ,/ate ag5cy means an ag5cy ( a ,/ate gov]nm5t e/abli%$ or designat$ to adm9i/] or sup]vise ! adm9i/ration ( a grant1 contract1 or o!r agreem5t fund$ 9 :ole or 9 "p by ! ,secret>y ( ,heal? & ,human ,s]vices4 7s7 ,= purposes ( subsection 7o71 ! t]m obligation means an e/abli%$ duty1 :e!r or n fix$1 aris+ f an express or impli$ contractual1 grantor-grantee1 or lic5sor-lic5see relation%ip1 = a fee-bas$ or simil> relation%ip1 f /atute or regulation1 or f ! ret5tion ( any ov]paym5t4 4 7b7 ,con=m+ am5dm5ts ,section #aabh;,a ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acbj;a-#g;a7 is am5d$-- 7#a7 9 subsection 7d7-- 7,a7 9 p>agraph 7#a71 by ins]t+ or specifi$ claims aft] claims2 & 7,b7 9 p>agraph 7#b71 by ins]t+ or specifi$ claims aft] claims2 7#b7 9 subsection 7e71 by ins]t+ or specifi$ claim aft] claim2 & 7#c7 9 subsection 7f7-- 7,a7 by ins]t+ or specifi$ claim 7z def9$ 9 subsection 7r77#f77 aft] di/rict :]e ! claim2 7,b7 by ins]t+ 7or1 ) respect to a p]son describ$ 9 subsection 7o71 ! p]son7 aft] claimant2 7,c7 by ins]t+ t are n receiv$ by ! ,inspector ,g5]al ( ! ,dep>tm5t ( ,heal? & ,human ,s]vices "u subsection 7q7 z reimbursem5t aft] am\nts recov]$2 & 7,d7 by ins]t+ 7or1 9 ! case ( a p5alty or assessm5t "u subsection 7o71 by a specifi$ ,/ate ag5cy 7z def9$ 9 subsection 7r77#g77 aft] or a ,/ate ag5cy4 ,b ,o!r ,re=ms #djda4 ,,spr drawd[n 7a7 ,drawd[n & sale ,not)/&+ section #afa ( ! ,en]gy ,policy & ,cons]vation ,act 7#db ,u4,s4,c4 #fbda71 except z provid$ 9 subsection 7b7 ! ,secret>y ( ,en]gy %all draw d[n & sell-- 7#a7 #d million b>rels ( crude oil f ! ,/rategic ,petroleum ,res]ve dur+ fiscal ye> #bjah2 7#b7 #e million b>rels ( crude oil f ! ,/rategic ,petroleum ,res]ve dur+ fiscal ye> #bjai2 7#c7 #h million b>rels ( crude oil f ! ,/rategic ,petroleum ,res]ve dur+ fiscal ye> #bjbj2 7#d7 #h million b>rels ( crude oil f ! ,/rategic ,petroleum ,res]ve dur+ fiscal ye> #bjba2 7#e7 #aj million b>rels ( crude oil f ! ,/rategic ,petroleum ,res]ve dur+ fiscal ye> #bjbb2 7#f7 #ae million b>rels ( crude oil f ! ,/rategic ,petroleum ,res]ve dur+ fiscal ye> #bjbc2 7#g7 #ae million b>rels ( crude oil f ! ,/rategic ,petroleum ,res]ve dur+ fiscal ye> #bjbd2 & 7#h7 #ae million b>rels ( crude oil f ! ,/rategic ,petroleum ,res]ve dur+ fiscal ye> #bjbe4 ,am\nts receiv$ = a sale "u ?is subsection %all be deposit$ 9 ! ,g5]al ,fund ( ! ,treasury dur+ ! fiscal ye> 9 :i* ! sale occurs4 7b7 ,em]g5cy protection ,! ,secret>y %all n draw d[n & sell crude oil "u ?is section 9 am\nts t w\ld result 9 a ,/rategic ,petroleum ,res]ve t conta9s an inv5tory ( petroleum products repres5t+ less ?an #ij days ( em]g5cy res]ves1 bas$ on ! av]age daily level ( net imports ( crude oil & petroleum products 9 ! previ\s cal5d> ye>4 7c7 ,proce$s ,proce$s f a sale "u ?is section %all be deposit$ into ! g5]al fund ( ! ,treasury ( ! ,unit$ ,/ates4 ,c ,miscellane\s #djfa4 ,lyme disease & o!r tick-borne diseases 7a7 ,9 g5]al ,title ,,iii ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bda et seq47 is am5d$ by add+ at ! end ! foll[+ new "p3 ,w ,lyme disease & o!r tick-borne diseases #cii,,oo4 ,rese>* 7a7 ,9 g5]al ,! ,secret>y %all conduct or support epidemiological1 basic1 translational1 & cl9ical rese>* reg>d+ ,lyme disease & o!r tick-borne diseases4 7b7 ,bi5nial reports ,! ,secret>y %all ensure t ea* bi5nial report "u section #djc includes in=mation on actions und]tak5 by ! ,national ,in/itutes ( ,heal? to c>ry out subsection 7a7 ) respect to ,lyme disease & o!r tick-borne diseases1 includ+ an assessm5t ( ! progress made 9 improv+ ! outcomes ( ,lyme disease & su* o!r tick-borne diseases4 #cii,,oo-#a4 ,work+ ,gr\p 7a7 ,e/abli%m5t ,! ,secret>y %all e/abli% a p]man5t work+ gr\p1 to be kn[n z ! ,int]ag5cy ,lyme & ,tick-,borne ,disease ,work+ ,gr\p 79 ?is section & section #cii,,oo-#b ref]r$ to z ! ,work+ ,gr\p71 to review all ef=ts )9 ! ,dep>tm5t ( ,heal? & ,human ,s]vices conc]n+ ,lyme disease & o!r tick-borne diseases to ensure int]ag5cy coord9ation1 m9imize ov]lap1 & exam9e rese>* priorities4 7b7 ,responsibilities ,! ,work+ ,gr\p %all-- 7#a7 n lat] ?an #bd mon?s aft] ! date ( enactm5t ( ?is "p1 & e #bd mon?s !reaft]1 develop or update a summ>y (-- 7,a7 ongo+ ,lyme disease & o!r tick-borne disease rese>* relat$ to causes1 prev5tion1 treatm5t1 surveillance1 diagnosis1 diagno/ics1 duration ( illness1 int]v5tion1 & access to s]vices & supports = individuals ) ,lyme disease or o!r tick-borne diseases2 7,b7 advances made pursuant to su* rese>*2 7,c7 ! engagem5t ( ! ,dep>tm5t ( ,heal? & ,human ,s]vices ) p]sons t p>ticipate at ! public meet+s requir$ by p>agraph 7#e72 & 7,d7 ! comm5ts receiv$ by ! ,work+ ,gr\p at su* public meet+s & ! ,secret>y's response to su* comm5ts2 7#b7 ensure t a broad spectrum ( sci5tific viewpo9ts is repres5t$ 9 ea* su* summ>y2 7#c7 monitor ,f$]al activities ) respect to ,lyme disease & o!r tick-borne diseases2 7#d7 make recomm5dations to ! ,secret>y reg>d+ any appropriate *anges to su* activities2 & 7#e7 ensure public input by hold+ annual public meet+s t address sci5tific advances1 rese>* que/ions1 surveillance activities1 & em]g+ /ra9s 9 species ( pa?og5ic organisms4 7c7 ,memb]%ip 7#a7 ,9 g5]al ,! ,work+ ,gr\p %all be compos$ ( a total ( #ad memb]s z foll[s3 7,a7 ,f$]al memb]s ,sev5 ,f$]al memb]s1 consi/+ ( "o or m repres5tatives ( ea* (-- 7i7 ! ,(fice ( ! ,assi/ant ,secret>y = ,heal?2 7ii7 ! ,food & ,drug ,adm9i/ration2 7iii7 ! ,c5t]s = ,disease ,control & ,prev5tion2 7iv7 ! ,national ,in/itutes ( ,heal?2 & 7v7 su* o!r ag5cies & (fices ( ! ,dep>tm5t ( ,heal? & ,human ,s]vices z ! ,secret>y det]m9es appropriate4 7,b7 ,non-,f$]al public memb]s ,sev5 non-,f$]al public memb]s1 consi/+ ( repres5tatives ( ! foll[+ categories3 7i7 ,physicians & o!r m$ical provid]s ) exp]i5ce 9 diagnos+ & treat+ ,lyme disease & o!r tick-borne diseases4 7ii7 ,sci5ti/s or rese>*]s ) exp]tise4 7iii7 ,pati5ts & _! family memb]s4 7iv7 ,nonpr(it organizations t advocate = pati5ts ) respect to ,lyme disease & o!r tick-borne diseases4 7v7 ,o!r individuals ^: exp]tise is det]m9$ by ! ,secret>y to be b5eficial to ! function+ ( ! ,work+ ,gr\p4 7#b7 ,appo9tm5t ,! memb]s ( ! ,work+ ,gr\p %all be appo9t$ by ! ,secret>y1 except t ( ! non-,f$]al public memb]s "u p>agraph 7#a77;,b7-- 7,a7 "o %all be appo9t$ by ! ,speak] ( ! ,h\se ( ,repres5tatives2 & 7,b7 "o %all be appo9t$ by ! majority lead] ( ! ,s5ate4 7#c7 ,div]sity ( sci5tific p]spectives ,9 mak+ appo9tm5ts "u p>agraph 7#b71 ! ,secret>y1 ! ,speak] ( ! ,h\se ( ,repres5tatives1 & ! majority lead] ( ! ,s5ate %all ensure t ! non-,f$]al public memb]s ( ! ,work+ ,gr\p repres5t a div]sity ( sci5tific p]spectives4 7#d7 ,t]ms ,! non-,f$]al public memb]s ( ! ,work+ ,gr\p %all ea* be appo9t$ to s]ve a #d-ye> t]m & may be reappo9t$ at ! end ( su* t]m4 7d7 ,meet+s ,! ,work+ ,gr\p %all meet z (t5 z necess>y1 z det]m9$ by ! ,secret>y1 b n less ?an twice ea* ye>4 7e7 ,applicability ( ,,faca ,! ,work+ ,gr\p %all be treat$ z an advisory committee subject to ! ,f$]al ,advisory ,committee ,act4 7f7 ,report+ ,n lat] ?an #bd mon?s aft] ! date ( enactm5t ( ?is "p1 & e #bd mon?s !reaft]1 ! ,work+ ,gr\p-- 7#a7 %all submit a report on its activities1 includ+ an up-to-date summ>y "u subsection 7b77#a7 & any recomm5dations "u subsection 7b77#d71 to ! ,secret>y1 ! ,committee on ,en]gy & ,comm]ce ( ! ,h\se ( ,repres5tatives1 & ! ,committee on ,heal?1 ,education1 ,labor1 & ,p5sions ( ! ,s5ate2 7#b7 %all make ea* su* report publicly available on ! website ( ! ,dep>tm5t ( ,heal? & ,human ,s]vices2 & 7#c7 %all all[ any memb] ( ! ,work+ ,gr\p to include 9 any su* report m9ority views4 #cii,,oo-#b4 ,/rategic plan ,n lat] ?an #c ye>s aft] ! date ( enactm5t ( ?is section1 & e #e ye>s !reaft]1 ! ,secret>y %all submit to ! ,congress a /rategic plan1 in=m$ by ! mo/ rec5t summ>y "u section #cii,,oo-#a7;b77#a71 = ! conduct & support ( ,lyme disease & tick-borne disease rese>*1 includ+-- 7#a7 propos$ budget>y requirem5ts2 7#b7 a plan = improv+ outcomes ( ,lyme disease & o!r tick-borne diseases1 includ+ progress relat$ to *ronic or p]si/5t symptoms & *ronic or p]si/5t infection & co-infections2 7#c7 a plan = improv+ diagnosis1 treatm5t1 & prev5tion2 7#d7 appropriate b5*m>ks to measure progress on a*iev+ ! improvem5ts describ$ 9 p>agraphs 7#b7 & 7#c72 & 7#e7 a plan to dissem9ate ea* summ>y "u section #cii,,oo-#a7;b77#a7 & o!r relevant in=mation develop$ by ! ,work+ ,gr\p to ! public1 includ+ heal? c>e provid]s1 public heal? dep>tm5ts1 & o!r relevant m$ical gr\ps4 4 7b7 ,no additional au?orization ( appropriations ,no additional funds are au?oriz$ to be appropriat$ = ! purpose ( c>ry+ out ?is section & ! am5dm5t made by ?is section1 & ?is section & su* am5dm5t %all be c>ri$ out us+ am\nts o!rwise available = su* purpose4 #djfb4 ,outrea* to hi/orically black colleges & univ]sities ,! ,secret>y ( ,heal? & ,human ,s]vices %all conduct outrea* to hi/orically ,black colleges & univ]sities1 ,hispanic-s]v+ in/itutions1 ,native ,am]ican colleges1 & rural colleges to ensure t heal? pr(essionals f und]repres5t$ populations are aw>e ( rese>* opportunities "u ?is ,act4 ,pass$ ! ,h\se ( ,repres5tatives ,july #aj1 #bjae4;,cl]k4