,i #aac? ,,congress #a/ ,session ,h4 ,r4 #bbhe ,,9 ,,! ,,h\se ,,( ,,repres5tatives ,june #f1 #bjac ,mr4 ,ma!son introduc$ ! foll[+ bill2 :i* 0 ref]r$ to ! ,committee on ,en]gy & ,comm]ce ,a ,,bill ,to am5d ! ,public ,heal? ,s]vice ,act to enhance ef=ts to address antimicrobial resi/ance1 & = o!r purposes4 #a4 ,%ort title ,?is ,act may be cit$ z ! ,/rategies to ,address ,antimicrobial ,resi/ance ,act4 #b4 ,f9d+s ,! ,congress f9ds z foll[s3 7#a7 ,! adv5t ( ! antibiotic era has sav$ millions ( lives & all[$ = incr$ible m$ical progress2 h[ev]1 ! increas$ use & ov]use ( antimicrobial drugs h correlat$ ) increas$ rates ( antimicrobial resi/ance4 7#b7 ,?r\gh mutation z well z o!r me*anisms1 bact]ia & o!r infecti\s disease-caus+ organisms--viruses1 fungi1 & p>asites--develop resi/ance to antimicrobial drugs ov] "t4 ,! m antimicrobial drugs are us$1 :e!r appropriately or inappropriately1 ! m ?is contributes to ! developm5t ( antimicrobial resi/ance4 7#c7 ,sci5tific evid5ce sugge/s t ! developm5t ( antimicrobial resi/ance 9 humans is n due only to use ( antimicrobial drugs 9 humans1 b also may be caus$ by ! use ( antimicrobial drugs 9 food-produc+ animals4 7#d7 ,a /udy e/imates t 9 #bjje m ?an #id1jjj invasive me?icill9-resi/ant ,/aphylococcus aureus 7,,mrsa7 bact]ial infections occurr$ 9 ! ,unit$ ,/ates & m ?an #ah1ejj ( ^! infections result$ 9 dea?--#g times m ?an a decade e>li]4 7#e7 ,! #bjji ,influ5za ,a3 ,h#a,n#a virus outbreak1 & ! ye>ly seasonal influ5za outbreaks1 exac]bate conc]ns ab\t antiviral resi/ance giv5 t s few antivirals are available to treat influ5za z well z second>y bact]ial infections due to ,,mrsa1 antibiotic-resi/ant ,/reptococcus pneumonia1 & o!r bact]ia t cause respiratory diseases4 ,giv5 t1 dur+ ! #aiah influ5za p&emic1 _m ?\s&s ( dea?s 7 caus$ by complications due to second>y bact]ial infections & n by ! influ5za virus itself4 7#f7 ,ea* ye>1 ne>ly #b1jjj1jjj p contract bact]ial infections 9 hospitals & approximately #ij1jjj ( ^! p die f ^! infections4 ,_m ( ^! infections are resi/ant to "o or m commonly us$ antibiotics4 7#g7 ,a #bjab /udy conduct$ at ,columbia ,univ]sity 7,cl9ical ,infecti\s ,disease1 ,septemb] #bjab7 f\nd t ea* antibiotic-resi/ant infection co/1 on av]age1 ov] #ae1jjj m to treat ?an susceptible infections4 7#h7 ,! co/s ( antimicrobial-resi/ant infections 9 t]ms ( lives lo/ & ! economy w only rise z antimicrobial resi/ance cont9ues to spread4 #c4 ,antimicrobial resi/ance task =ce ,section #cai;,e ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bdg;d-#e7 is am5d$-- 7#a7 9 subsection 7a7-- 7,a7 9 ! subsection head+1 by /rik+ ,task ,=ce & ins]t+ ! foll[+3 ,antimicrobial ,resi/ance ,(fice1 ,task ,=ce1 & ,advisory ,bo>d2 7,b7 9 p>agraph 7#a7-- 7i7 by /rik+ z ( ! date ( ! enactm5t ( ?is section & ins]t+ z ( ,septemb] #cj1 #bjjf2 & 7ii7 by add+ at ! end ! foll[+3 ,! ,secret>y %all1 n lat] ?an #a ye> aft] ! date ( enactm5t ( ! ,/rategies to ,address ,antimicrobial ,resi/ance ,act1 direct ! ,assi/ant ,secret>y ( ,heal? to e/abli% an ,antimicrobial ,resi/ance ,(fice & appo9t a director to t ,(fice4 ,! ,secret>y %all1 n lat] ?an #a ye> aft] ! date ( enactm5t ( su* ,act1 e/abli% ! ,public ,heal? ,antimicrobial ,advisory ,bo>d z an advisory bo>d to ! ,director ( ! ,antimicrobial ,resi/ance ,(fice4 ,! ,director ( ! ,antimicrobial ,resi/ance ,(fice %all s]ve z ! ,director ( ! ,antimicrobial ,resi/ance ,task ,=ce4 ,to avoid duplication & ensure t ,f$]al res\rces are us$ effici5tly & effectively1 ! ,director %all "w 9 conjunction ) ! ,f$]al ag5cies repres5t$ on ! ,task ,=ce to coord9ate all antimicrobial resi/ance activities und]tak5 & support$ by ! ,f$]al ,gov]nm5t1 includ+ ! activities & budget>y allocations ( ! ,(fice1 ,task ,=ce1 & ,public ,heal? ,antimicrobial ,advisory ,bo>d42 7,c7 by am5d+ p>agraph 7#b7 to read z foll[s3 7#b7 ,memb]s 7,a7 ,memb]s ( ! antimicrobial resi/ance task =ce ,! task =ce describ$ 9 p>agraph 7#a7 %all be compos$ ( repres5tatives ( su* ,f$]al ag5cies z ! ,secret>y det]m9es necess>y1 includ+ repres5tation ( ! foll[+3 7i7 ,! ,antimicrobial ,resi/ance ,(fice4 7ii7 ,! ,assi/ant ,secret>y = ,prep>$ness & ,response4 7iii7 ,! ,biom$ical ,advanc$ ,rese>* & ,developm5t ,au?ority4 7iv7 ,! ,c5t]s = ,disease ,control & ,prev5tion4 7v7 ,! ,food & ,drug ,adm9i/ration4 7vi7 ,! ,national ,in/itutes ( ,heal?4 7vii7 ,! ,ag5cy = ,heal?c>e ,rese>* & ,quality4 7viii7 ,! ,c5t]s = ,m$ic>e ,m$icaid ,s]vices4 7ix7 ,! ,heal? ,res\rces & ,s]vices ,adm9i/ration4 7x7 ,! ,dep>tm5t ( ,agriculture4 7xi7 ,! ,dep>tm5t ( ,education4 7xii7 ,! ,dep>tm5t ( ,def5se4 7xiii7 ,! ,dep>tm5t ( ,vet]ans ,affairs4 7xiv7 ,! ,environm5tal ,protection ,ag5cy4 7xv7 ,! ,dep>tm5t ( ,homel& ,security4 7xvi7 ,! ,unit$ ,/ates ,ag5cy = ,int]national ,developm5t4 7,b7 ,memb]s ( ! public heal? antimicrobial advisory bo>d 7i7 ,9 g5]al ,! ,public ,heal? ,antimicrobial ,advisory ,bo>d %all be compos$ ( #ai vot+ memb]s1 appo9t$ by ! ,secret>y4 ,su* memb]s %all include exp]ts f ! m$ical pr(essions 7includ+ hospital & community-bas$ physicians71 ph>macy1 public heal?1 vet]9>y1 rese>*1 & int]national heal? communities1 z well z "o repres5tative f a public int]e/ gr\p4 7ii7 ,t]ms ,ea* memb] appo9t$ "u clause 7i7 %all be appo9t$ = a t]m ( #c ye>s1 except t ( ! #ai memb]s fir/ appo9t$-- 7,i7 #f %all be appo9t$ = a t]m ( #ab mon?s2 & 7,,ii7 #f %all be appo9t$ = a t]m ( #b ye>s4 7iii7 ,*air ,! ,secret>y %all appo9t a ,*air ( ! ,public ,heal? ,antimicrobial ,advisory ,bo>d f among its memb]s to lead & sup]vise ! activities ( ! ,advisory ,bo>d4 7iv7 ,disclosure ( f9ancial int]e/s ,prior to a meet+ ( ! ,public ,heal? ,antimicrobial ,advisory ,bo>d1 ea* memb] ( ! ,advisory ,bo>d %all disclose to ! ,secret>y any pot5tial1 relevant f9ancial int]e/s z def9$ "u section #bjh7;a7 ( title #ah1 ,unit$ ,/ates ,code4 2 7,d7 9 p>agraph 7#c77;,b71 by /rik+ 9 consultation ) ! task =ce describ$ 9 p>agraph 7#a7 & & ins]t+ act+ ?r\gh ! ,director ( ! ,antimicrobial ,resi/ance ,(fice & ! ,director ( ! ,c5t]s = ,disease ,control & ,prev5tion1 & 9 consultation )2 & 7,e7 by am5d+ p>agraph 7#d7 to read z foll[s3 7#d7 ,meet+s & duties 7,a7 ,antimicrobial resi/ance (fice duties ,! ,director ( ! ,antimicrobial ,resi/ance ,(fice1 work+ 9 conjunction ) ! ,f$]al ag5cies t are repres5t$ on ! task =ce describ$ 9 p>agraph 7#a71 %all issue an update to ! ,public ,heal? ,action ,plan to ,combat ,antimicrobial ,resi/ance )9 #a ye> ( ! e/abli%m5t ( ! ,(fice & annually !reaft]4 ,! updates %all include enhanc$ plans = address+ antimicrobial resi/ance 9 ! ,unit$ ,/ates & int]nationally4 ,! ,director ( ! ,(fice %all po/ on a website ^! updates z well z summ>ies ( all non-propriet>y data ! ,task ,=ce makes available4 ,! ,director ( ! ,antimicrobial ,resi/ance ,(fice %all "w 9 conjunction ) ! ,f$]al ag5cies t are repres5t$ on ! task =ce describ$ 9 p>agraph 7#a71 & 9 consultation ) ! ,public ,heal? ,antimicrobial ,advisory ,bo>d1 to-- 7i7 e/abli% b5*m>ks = a*iev+ ! goals set =? 9 ! action plan2 7ii7 assess ! ongo+1 obs]v$ patt]ns ( em]g5ce ( antimicrobial resi/ance1 & _! impact on cl9ical outcomes 9 t]ms ( h[ pati5ts feel1 function1 or survive2 7iii7 assess h[ antimicrobial products are be+ us$ 9 humans1 animals1 plants1 & ! environm5t & ! risks & b5efits ( ^? uses 9 fur!r+ ! developm5t ( resi/ance & ! implications !re( = pati5t safety & public heal?2 7iv7 e/abli% a priority li/ ( human infecti\s diseases ) ! greate/ ne$ = developm5t ( new po9t-(-c>e & o!r diagno/ics1 antimicrobial drugs1 & vacc9es1 & 9 p>ticul> s]i\s & life-?reat5+ resi/ant infections1 = :i* !re are few or no diagno/ic1 treatm5t1 or prev5tion options2 7v7 recomm5d basic1 cl9ical1 epidemiological1 prev5tion1 & translational rese>* :]e additional f$]ally support$ /udies may be b5eficial2 7vi7 recomm5d h[ to support antimicrobial developm5t ?r\gh ,food & ,drug ,adm9i/ration activities1 includ+ ?r\gh ! ag5cy's ,critical ,pa? ,initiative & ! ,reagan-,udall ,f\ndation2 7vii7 recomm5d h[ be/ to /r5g!n & l9k antimicrobial resi/ance-relat$ surveillance & prev5tion & control activities2 & 7viii7 collaborate ) ! ,assi/ant ,secret>y = ,prep>$ness & ,response to ensure t /rategies to address antimicrobial-resi/ance are coord9at$ ) initiatives aim$ at p&emic influ5za1 sev]e acute respiratory syndrome1 & biot]rorism4 7,b7 ,antimicrobial resi/ance task =ce meet+s & duties 7i7 ,meet+s ,! ,antimicrobial ,resi/ance ,task ,=ce %all conv5e p]iodically z ! ,director ( ! ,antimicrobial ,resi/ance ,task ,=ce det]m9es to be appropriate1 b n few] ?an twice a ye>1 to consid] issues relat+ to antimicrobial resi/ance4 7ii7 ,public heal? action plan ,at lea/ twice a ye>1 ! task =ce describ$ 9 p>agraph 7#a7 %all h a meet+ to review1 discuss1 & fur!r develop ! ,public ,heal? ,action ,plan to ,combat ,antimicrobial ,resi/ance fir/ issu$ by ! int]ag5cy task =ce on antimicrobial resi/ance 9 #bjja4 ,among o!r issues1 ! task =ce may discuss & review1 bas$ on curr5t ne$ or conc]n-- 7,i7 antimicrobial cl9ical susceptibility conc5trations propos$1 e/abli%$1 or updat$ by ! ,food & ,drug ,adm9i/ration2 7,,ii7 data obta9$ by gov]nm5t ag5cies &1 z possible1 by private s\rces on em]g+ antimicrobial resi/ance relat$ to cl9ical outcomes z well z data relat$ to h[ antimicrobial drugs may h be5 us$ inappropriately2 7,,iii7 surveillance data & prev5tion & control activities reg>d+ em]g+ antimicrobial resi/ance f reliable s\rces includ+ ! ,c5t]s = ,disease ,control & ,prev5tion1 ! ,food & ,drug ,adm9i/ration1 ! ,dep>tm5t ( ,def5se1 ! ,dep>tm5t ( ,vet]ans ,affairs1 ! ,dep>tm5t ( ,agriculture1 ! ,environm5tal ,protection ,ag5cy1 & z feasible f private s\rces & int]national bodies2 7,,iv7 data on ! am\nt ( antimicrobial products us$ 9 humans1 animals1 plants1 & ! environm5t f reliable s\rces1 includ+ data f ! ,c5t]s = ,disease ,control & ,prev5tion1 ! ,food & ,drug ,adm9i/ration1 ! ,environm5tal ,protection ,ag5cy1 ! ,dep>tm5t ( ,vet]ans ,affairs1 ! ,c5t]s = ,m$ic>e ,m$icaid ,s]vices1 ! ,dep>tm5t ( ,homel& ,security1 & ! ,dep>tm5t ( ,agriculture1 & z feasible f private s\rces & int]national bodies2 7,v7 ! impact ( antimicrobial resi/ance on human heal? result+ f ! approval ( antimicrobial drugs = use 9 humans1 animals1 or plants 7includ+ consid]ation ( & recomm5dations on pot5tial managem5t plans to limit & r$uce ! negative impacts ( su* resi/ance on human heal? & consid]ation ( ! b5efits to animal heal? & food safety72 7,,vi7 reports ( f$]ally support$ antimicrobial resi/ance rese>* & antimicrobial drug1 relat$ diagno/ics1 & vacc9e developm5t = antimicrobial resi/ant infections 7su* z me?icill9-resi/ant ,/aphylococcus aureus 7,,mrsa77 & o!r rese>* activities 7includ+ cl9ical1 epidemiological1 prev5tion1 & translational rese>*7 obta9$ f ,f$]al ag5cies1 z well z reports ( rese>* sponsor$ by o!r c\ntries1 indu/ry1 & non-gov]nm5tal organizations2 7,,vii7 reports on ef=ts by ! ,food & ,drug ,adm9i/ration to develop policies & guidance :i* enc\rage antimicrobial drug1 relat$ diagno/ics1 & vacc9e developm5t & appropriate use :ile ma9ta9+ high /&>ds = safety & effectiv5ess2 7,,viii7 quality measures1 :i* may include heal? plan employ] data & in=mation set 7,,h$is7 measures1 p]ta9+ to appropriate use ( antimicrobial drugs2 & 7,,ix7 o!r data & issues ! task =ce describ$ 9 p>agraph 7#a7 id5tifies z relevant to ! issue ( antimicrobial resi/ance4 7iii7 ,p5d+ applications ,! ,food & ,drug ,adm9i/ration may consult ) ! ,director ( ! ,antimicrobial ,resi/ance ,(fice conc]n+ ! p5d+ application ( any antimicrobial drug application submitt$ to ! ,secret>y "u section #eje or #eab ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act or ! ,public ,heal? ,s]vice ,act4 7,c7 ,public heal? antimicrobial advisory bo>d meet+s & duties 7i7 ,meet+s ,! ,public ,heal? ,antimicrobial ,advisory ,bo>d %all meet z ! ,*air ( ! ,public ,heal? ,antimicrobial ,advisory ,bo>d det]m9es to be appropriate1 pref]ably 9 conjunction ) meet+s ( ! ,antimicrobial ,resi/ance ,task ,=ce1 b n few] ?an #b times ea* ye>4 7ii7 ,recomm5dations ,! ,public ,heal? ,antimicrobial ,advisory ,bo>d %all make recomm5dations to ! ,secret>y1 & ! ,antimicrobial ,resi/ance ,(fice1 reg>d+-- 7,i7 ways to enc\rage ! availability ( an adequate supply ( safe & effective antimicrobial products1 relat$ diagno/ics1 & vacc9es2 7,,ii7 rese>* priorities & o!r measures 7su* z antimicrobial drug resi/ance managem5t plans7 to enhance ! safety & efficacy ( antimicrobial products2 7,,iii7 h[ be/ to implem5t & update ! goals ( ! ,public ,heal? ,action ,plan to ,combat ,antimicrobial ,resi/ance2 7,,iv7 inc5tives necess>y to e/abli% uni=m me*anisms 7:i* c\ld include electronic surveillance sy/ems7 & data sets = ,/ate & local report+ ( resi/ance2 7,v7 ! adequacy ( exi/+ ,unit$ ,/ates antimicrobial resi/ance & use surveillance2 7,,vi7 ! developm5t ( a national plan = ! collection & analysis ( isolates ( resi/ant pa?og5s1 includ+ e/abli%+ priorities z to :i* isolates %\ld be collect$2 & 7,,vii7 areas = gov]nm5t1 nongov]nm5t1 & int]national coop]ation to /r5g!n implem5tation ( ! ,public ,heal? ,action ,plan to ,combat ,antimicrobial ,resi/ance4 7,d7 ,availability ( in=mation ,! ,antimicrobial ,resi/ance ,(fice %all ensure t all in=mation %all be made available to ! public on ! website describ$ 9 subp>agraph 7,a7 consi/5t ) section #i ( ! ,/rategies to ,address ,antimicrobial ,resi/ance ,act4 2 7#b7 by am5d+ subsection 7b7 to read z foll[s3 7b7 ,antimicrobial resi/ance /rategic rese>* plan ,! ,secret>y1 act+ ?r\gh ! ,director ( ! ,national ,in/itutes ( ,heal?1 work+ 9 consultation ) ! ,director ( ! ,c5t]s = ,disease ,control & ,prev5tion1 ! ,assi/ant ,secret>y = ,prep>$ness & ,response1 ! ,director ( ! ,biom$ical ,advanc$ ,rese>* & ,developm5t ,au?ority1 ! ,director ( ! ,antimicrobial ,resi/ance ,(fice1 ! ,public ,heal? ,antimicrobial ,advisory ,bo>d1 & o!r non-gov]nm5t exp]ts1 includ+ repres5tatives f pr(essional societies & ! ph>maceutical1 vacc9e1 & m$ical device indu/ries1 & o!r ,f$]al ag5cies %all develop a blue-ribbon antimicrobial resi/ance /rategic rese>* plan t /r5g!ns exi/+ epidemiological1 int]v5tional1 cl9ical1 behavioral1 translational1 & basic rese>* ef=ts to advance ! und]/&+ (-- 7#a7 ! developm5t1 implem5tation1 & efficacy ( int]v5tions to prev5t & control ! em]g5ce & transmission ( antimicrobial resi/ance2 7#b7 h[ be/ to optimize antimicrobial effectiv5ess :ile limit+ ! em]g5ce ( resi/ance1 includ+ address+ issues relat$ to duration ( !rapy1 effectiv5ess ( !rapy 9 self-resolv+ diseases1 & det]m9+ populations mo/ likely to b5efit f antimicrobial drugs2 7#c7 ! ext5t to :i* specific uses ( antimicrobial products 9 humans1 animals1 plants1 & o!r uses accel]ates developm5t & transmission ( antimicrobial resi/ance2 7#d7 ! natural hi/ories ( infecti\s diseases 7includ+ def9+ ! disease1 diagnosis1 sev]ity1 & ! "t c\rse ( illness72 7#e7 ! developm5t ( new !rapeutics1 includ+ antimicrobial drugs1 biologics1 & devices aga9/ resi/ant pa?og5s1 & 9 p>ticul> diseases = :i* few or no !rapeutics are 9 developm5t2 7#f7 ! developm5t & te/+ ( m$ical diagno/ics to id5tify pati5ts ) infecti\s disease & id5tify ! exact cause ( infecti\s diseases syndromes1 p>ticul>ly ) respect to ! detection ( pa?og5s resi/ant to antimicrobial drugs2 7#g7 ! epidemiology1 pa?og5esis1 me*anisms1 & g5etics ( antimicrobial resi/ance2 & 7#h7 ! sequ5c+ ( ! g5omes1 or o!r ,,dna analysis1 or o!r comp>ative analysis ( priority pa?og5s 7z det]m9$ by ! ,public ,heal? ,antimicrobial ,advisory ,bo>d71 9 collaboration ) ! ,dep>tm5t ( ,def5se & ! ,jo9t ,g5ome ,in/itute ( ! ,dep>tm5t ( ,en]gy4 2 7#c7 9 subsection 7c7-- 7,a7 by ins]t+ act+ ?r\gh ! ,director ( ! ,antimicrobial ,resi/ance ,(fice1 aft] ,! ,secret>y12 & 7,b7 by /rik+ memb]s ( ! task =ce describ$ 9 subsection 7a712 7#d7 9 subsection 7d77#a71 by ins]t+ 1 ?r\gh ! ,antimicrobial ,resi/ance ,(fice1 aft] ,! ,secret>y2 7#e7 9 subsection 7e7-- 7,a7 by am5d+ ! subsection head+ to read z foll[s3 ,improv+ ,uptake & ,measurem5t ( ,antimicrobial ,/ew>d%ip2 7,b7 9 p>agraph 7#a7-- 7i7 by ins]t+ 1 act+ ?r\gh ! ,director ( ! ,antimicrobial ,resi/ance ,(fice1 aft] ,! ,secret>y2 & 7ii7 by /rik+ judici\s use ( antimicrobial drugs or control ! spread ( antimicrobial-resi/ant pa?og5s & ins]t+ ! uptake & measurem5t ( antimicrobial /ew>d%ip programs 9 ! ,nation's heal? c>e facilities2 7,c7 9 p>agraph 7#b71 by /rik+ laboratory2 7,d7 9 p>agraph 7#c71 by ins]t+ 1 act+ ?r\gh ! ,antimicrobial ,resi/ance ,(fice1 aft] ,! ,secret>y2 & 7,e7 by add+ at ! end ! foll[+ new p>agraphs3 7#d7 ,def9ition ( antimicrobial /ew>d%ip ,= purposes ( ?is subsection & ,act1 antimicrobial /ew>d%ip means coord9at$ int]v5tions design$ to improve & measure ! appropriate use ( antimicrobial ag5ts1 includ+ promot+ ! use ( antimicrobials only :5 cl9ically indicat$1 &1 :5 antimicrobials are indicat$1 promot+ ! selection ( ! optimal antimicrobial drug regim5 includ+ dos+1 duration ( !rapy1 & r\te ( adm9i/ration4 7#e7 ,pref]5ce 9 mak+ aw>ds ,9 mak+ aw>ds "u p>agraph 7#a71 ! ,secret>y %all give pref]5ce to eligible entities t w use grant funds to e/abli% demon/ration projects t lead to ! developm5t ( quality measures = heal? c>e provid]s prescrib+ antimicrobial drugs4 2 7#f7 by r$esignat+ subsections 7f7 & 7g7 z subsections 7i7 & 7j71 respectively2 & 7#g7 by ins]t+ aft] subsection 7e7 ! foll[+ new subsections3 7f7 ,appropriate antimicrobial use ,! ,secret>y1 act+ ?r\gh ! ,director ( ! ,c5t]s = ,disease ,control & ,prev5tion1 %all take su* additional actions z foll[s3 7#a7 ,to pilot & te/ heal? c>e quality measures to help provid]s1 facilities1 & heal? sy/ems measure & b5*m>k appropriate antimicrobial use4 ,z appropriate1 ! ,director %all "w ) /&>d sett+ organizations 7su* z ! ,national ,quality ,=um1 ! ,jo9t ,commission1 & ! ,national ,committee = ,quality ,assurance7 to det]m9e if any su* measure is suitable = national quality report+ ef=ts4 7#b7 ,to develop me?ods to help provid]s1 facilities1 & heal? sy/ems measure & improve appropriate antimicrobial use1 includ+ me?ods & tools to assess ! *ange 9 antimicrobial use1 ! impact on antibiotic resi/ance & adv]se effects 7su* z ,clo/ridium difficile infections71 & ! economic impact & co/ sav+s ( antimicrobial /ew>d%ip programs4 7g7 ,collection ( human antimicrobial consumption & resi/ance tr5d data 7#a7 ,antimicrobial ,use ,data ,! ,director ( ! ,c5t]s = ,disease ,control & ,prev5tion %all "w ) private v5dors1 heal? c>e organizations1 ph>macy b5efit manag]s1 & o!r entities to obta9 reliable & comp>able human antimicrobial drug consumption data 7includ+ volume antimicrobial di/ribution data & antimicrobial use1 includ+ prescription data7 by ,/ate or metropolitan area4 7#b7 ,antimicrobial ,resi/ance ,tr5d ,data ,! ,director ( ! ,c5t]s = ,disease ,control & ,prev5tion %all int5sify & exp& _! ef=ts to collect antimicrobial resi/ance data includ+ ?r\gh ! e/abli%m5t ( an ,antimicrobial ,resi/ance ,surveillance & ,laboratory ,network1 e/abli%$ 9 section #d ( ! ,/rategies to ,address ,antimicrobial ,resi/ance ,act1 & developm5t ( a fully automat$ antimicrobial resi/ance & use module )9 ! ,national ,heal?c>e ,safety ,network4 ,! ,director %all seek to collect data f electronic m$ication adm9i/ration reports 7e,m,a,r7 & laboratory sy/ems to produce regul> reports on antimicrobial resi/ance patt]ns & antimicrobial use4 7#c7 ,mean+ful ,use ,report+ ,! ,(fice ( ! ,national ,coord9ator = ,heal? ,in=mation ,te*nology %all "w ) ! ,director ( ! ,c5t]s = ,disease ,control & ,prev5tion to det]m9e h[ be/ antimicrobial use1 susceptibility1 & resi/ance data c be incorporat$ into mean+ful use report+4 7#d7 ,report ,n lat] ?an #b ye>s aft] ! date ( ! enactm5t ( ! ,/rategies to ,address ,antimicrobial ,resi/ance ,act1 & e two ye>s !reaft]1 ! ,director ( ! ,c5t]s = ,disease ,control & ,prev5tion %all submit to ! ,committee on ,en]gy & ,comm]ce ( ! ,h\se ( ,repres5tatives & ! ,committee on ,heal?1 ,education1 ,labor & ,p5sions ( ! ,s5ate & make available on ! ag5cy's website a report summ>iz+ key tr5ds & major issues relat$ to antimicrobial resi/ance & use 9 ! ,unit$ ,/ates4 ,ea* su* report %all include ! mo/ relevant & up-to-date data available f ! infecti\s diseases & surveillance programs ( ! ,c5t]s = ,disease ,control & ,prev5tion4 ,ea* su* report %all-- 7,a7 outl9e major issues & ?reats 9 antimicrobial resi/ance fac+ ! ,unit$ ,/ates2 7,b7 provide data on ! incid5ce1 preval5ce1 morbidity1 mortality1 & g5]al societal burd51 includ+ economic1 ( antimicrobial resi/ant pa?og5s2 7,c7 provide updates on resi/ance patt]ns & antimicrobials use data & pot5tial impacts on human heal? & pati5t safety2 7,d7 articulate activities ( ! ,c5t]s = ,disease ,control & ,prev5tion t>get$ t[>d measur+ & prev5t+ ! spread ( drug resi/ant pa?og5s2 7,e7 describe any int]national developm5ts t may impact antimicrobial resi/ance 9 ! ,unit$ ,/ates2 & 7,f7 id5tify ! major gaps t ! ,nation faces 9 ! areas ( antimicrobial resi/ance surveillance1 prev5tion1 use1 & antimicrobial /ew>d%ip4 7h7 ,ensure access to antimicrobial resi/ance data & rese>* ,! ,director ( ! ,antimicrobial ,resi/ance ,(fice %all "w ) ! ,f$]al ag5cies repres5t$ on ! ,antimicrobial ,resi/ance ,task ,=ce to id5tify relevant data & =mats1 & me*anisms = communicat+ su* data to ! ,antimicrobial ,resi/ance ,(fice & ,antimicrobial ,resi/ance ,task ,=ce &1 9 a mann] consi/5t ) section #i ( ! ,/rategies to ,address ,antimicrobial ,resi/ance ,act1 ) ! ,public ,heal? ,antimicrobial ,advisory ,bo>d & ! public1 includ+ relevant data obta9$ by ! ag5cies ?r\gh contracts ) o!r organizations1 includ+-- 7#a7 use & cl9ical outcomes data on pati5ts receiv+ antimicrobial drugs = ! treatm5t1 prev5tion1 or diagnosis ( infection or infecti\s diseases2 7#b7 surveillance data reg>d+ em]g+ antimicrobial drug resi/ance & exi/+ resi/ance patt]ns2 7#c7 susceptibility data relat$ to antimicrobial drug use2 7#d7 data relat$ to ! am\nt ( antimicrobial products us$ 9 humans1 animals1 plants1 & ! environm5t2 7#e7 data f f$]ally fund$ rese>* int5d$ to support antimicrobial drug1 vacc9e1 & relat$ diagno/ics developm5t2 7#f7 data demon/rat+ ! impact ( rese>*1 surveillance1 & prev5tion & control initiatives 9 und]/&+ & controll+ antimicrobial resi/ance2 & 7#g7 data reg>d+ implem5tation & evaluation ( int]v5tions to improve antimicrobial drug prescrib+ practices4 4 #d4 ,antimicrobial resi/ance surveillance & laboratory network 7a7 ,9 g5]al ,! ,secret>y ( ,heal? & ,human ,s]vices1 act+ ?r\gh ! ,director ( ! ,c5t]s = ,disease ,control1 %all e/abli% at lea/ #aj ,antimicrobial ,resi/ance ,surveillance & ,laboratory ,network sites1 build+ ^u ! intramural & extramural programs & laboratories ( ! ,c5t]s = ,disease ,control & ,prev5tion1 to int5sify1 /r5g!n1 & exp& ! national capacity to-- 7#a7 monitor ! em]g5ce & *anges 9 ! patt]ns ( antimicrobial resi/ant pa?og5s2 7#b7 describe1 confirm1 & z necess>y facilitate a response to local or regional outbreaks ( resi/ant pa?og5s2 7#c7 assess & describe antimicrobial resi/ance patt]ns to in=m public heal? & improve prev5tion practices2 7#d7 obta9 isolates ( pa?og5s1 & 9 p>ticul>1 pa?og5s t %[ new or atypical patt]ns ( resi/ance adv]sely affect+ public heal?2 7#e7 /udy ! epidemiology ( infections f su* pa?og5s2 7#f7 evaluate commonly us$ antimicrobial susceptibility te/+ me?ods to improve ! accuracy ( resi/ance te/+ & report+2 & 7#g7 z necess>y1 develop novel diagno/ic te/s capable ( detect+ new or em]g+ resi/ance 9 pa?og5s4 7b7 ,geographic di/ribution ,! sites e/abli%$ "u subsection 7a7 %all be geographically di/ribut$ across ! ,unit$ ,/ates4 7c7 ,nonduplication ( curr5t national capacity ,! sites e/abli%$ "u subsection 7a7 may be bas$ 9 academic c5t]s1 heal? dep>tm5ts1 & exi/+ surveillance & laboratory sites4 #e4 ,cl9ical trials network on antibact]ial resi/ance 7a7 ,9 ,g5]al ,! ,secret>y1 act+ ?r\gh ! ,director ( ! ,national ,in/itute ( ,all]gy & ,infecti\s ,diseases1 %all e/abli% a ,cl9ical ,trials ,network on ,antibact]ial ,resi/ance to enhance1 /r5g!n1 & exp& rese>* on cl9ical sci5ce1 antibact]ial & diagno/ic developm5t1 & optimal usage /rategies1 & %all1 at a m9imum-- 7#a7 facilitate rese>* to bett] und]/& resi/ance me*anisms & h[ to prev5t1 control1 & treat resi/ant organisms2 7#b7 advance cl9ical trial ef=ts to develop antimicrobial !rapies1 vacc9es & diagno/ics1 & evaluate & optimize _! usage2 7#c7 conduct cl9ical rese>* to develop natural hi/ories ( resi/ant infecti\s diseases2 7#d7 exam9e pati5t outcomes ) curr5tly available antimicrobial !rapy & validate & improve ^u biom>k]s & o!r surrogate endpo9ts2 & 7#e7 /udy %ort] treatm5t duration & e>ly cessation ( antimicrobial !rapy = treatm5t efficacy & effect on developm5t ( resi/ance4 7b7 ,lead]%ip ,gr\p = a ,cl9ical ,rese>* ,network on ,antibact]ial ,resi/ance ,! ,secret>y1 act+ ?r\gh ! ,director ( ! ,national ,in/itute ( ,all]gy & ,infecti\s ,diseases1 %all e/abli% a ,lead]%ip ,gr\p = ! ,cl9ical ,rese>* ,network on ,antibact]ial ,resi/ance describ$ 9 subsection 7a7 to develop & implem5t a compreh5sive cl9ical rese>* ag5da to address antibact]ial resi/ance t takes into consid]ation ! recomm5dations conta9$ 9 ! ,/rategic ,rese>* ,plan on ,antimicrobial ,resi/ance develop$ 9 accordance ) section #cai;,e ( ! ,public ,heal? ,s]vice ,act4 ,! ,lead]%ip ,gr\p %all provide support = ! foll[+ compon5ts-- 7#a7 sci5tific lead]%ip & op]ations2 7#b7 network laboratories2 & 7#c7 /ati/ical & data managem5t4 7c7 ,appropriations ,!re are au?oriz$ to be appropriat$ f ! exi/+ budget ( ! ,national ,in/itute ( ,all]gy & ,infecti\s ,diseases1 #ajj1jjj1jjj annually = ea* ( fiscal ye>s #bjad ?r\gh #bjbj to c>ry out ?is section4 #f4 ,regional prev5tion collaboratives ,! ,secret>y1 act+ ?r\gh ! ,director ( ! ,c5t]s = ,disease ,control & ,prev5tion1 %all "w ) ,/ate heal? dep>tm5ts to support regional prev5tion collaboratives design$ to int]rupt & prev5t ! transmission ( significant antibiotic resi/ant pa?og5s be+ transmitt$ across heal? c>e sett+s 9 a geographic region4 ,su* regional prev5tion collaboratives %all "w to-- 7#a7 id5tify significant drug resi/ant pa?og5s be+ transmitt$ across heal? c>e sett+s locally2 7#b7 implem5t evid5ce-bas$ int]v5tions to int]rupt & prev5t ! transmission ( su* pa?og5s2 & 7#c7 evaluate ! impact ( su* measures on hospital readmissions1 transitions ( c>e1 rates ( heal? c>e associat$ infections1 or any o!r relevant measures t *>act]ize ! heal? or economic impact ( ! collaboratives4 #g4 ,prev5tion ,epic5t]s ,to provide ! regional prev5tion collaboratives e/abli%$ "u section #f ) tools1 /rategies1 & evid5ce-bas$ int]v5tions1 ! ,director ( ! ,c5t]s = ,disease ,control & ,prev5tion may int5sify & exp& academic public heal? p>tn]%ips ?r\gh ! "w ( ! ,prev5tion ,epic5t]s ,program ( ! ,c5t]s ( ,disease ,control & ,prev5tion4 ,! ,c5t]s = ,disease ,control & ,prev5tion & ! epic5t]s p>ticipat+ 9 su* program %all "w ) ! regional prev5tion collaboratives to-- 7#a7 evaluate new & exi/+ int]v5tions to prev5t or limit ! em]g5ce ( antimicrobial resi/ance ?r\gh\t ! geographic region ( ! collaboratives2 7#b7 facilitate public heal? rese>* on ! prev5tion & control ( resi/ant organisms2 & 7#c7 assess ! feasibility1 co/-effectiv5ess1 & appropriat5ess ( surveillance & prev5tion programs 9 diff]+ heal? c>e & in/itutional sett+s4 #h4 ,cont9uation ( curr5t programs ,subsection 7j7 ( section #cai;,e ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bdg;d-#e71 z r$esignat$ by section #c7f71 is am5d$ by ins]t+ & = ea* ( ! fiscal ye>s #bjad ?r\gh #bjah aft] #bjjf4 #i4 ,protection ( confid5tial & national security in=mation ,except z o!rwise requir$ by law1 ?is ,act 7& ! am5dm5ts made by ?is ,act7 %all n p]mit public disclosure ( trade secrets1 confid5tial comm]cial in=mation1 or mat]ial inconsi/5t ) national security t is obta9$ by any p]son "u ?is ,act 7or am5dm5ts made by ?is ,act74