,i #aae? ,,congress #b;d ,session ,h4 ,r4 #fdba ,,9 ,,! ,,h\se ,,( ,,repres5tatives ,july #ah1 #bjah,mr4 ,sessions 7= himself1 ,mr4 ,bi%op ( ,georgia1 ,mr4 ,upton1 & ,mr4 ,bilirakis7 introduc$ ! foll[+ bill2 :i* 0 ref]r$ to ! ,committee on ,en]gy & ,comm]ce ,a ,,bill ,to advance treatm5t & cures = bl9dness & o!r ret9al conditions & to promote competitiv5ess 9 ! ,unit$ ,/ates ?r\gh a pilot program to increase fund+ = translational rese>*1 & = o!r purposes4 #a4 ,%ort title ,?is ,act may be cit$ z ! ,fa/] ,treatm5ts & ,cures = ,eye ,diseases ,act4 #b4 ,def9itions ,= purposes ( ?is ,act3 7#a7 ,applicable congressional committees ,! t]m applicable congressional committees means ! ,committees on ,en]gy & ,comm]ce & ,f9ancial ,s]vices ( ! ,h\se ( ,repres5tatives & ! ,committees on ,bank+1 ,h\s+1 & ,urban ,affairs & ,heal?1 ,education1 ,labor1 & ,p5sions ( ! ,s5ate4 7#b7 ,appropriate ,f$]al bank+ ag5cy ,! t]m appropriate ,f$]al bank+ ag5cy has ! mean+ giv5 t t]m 9 section #c ( ! ,f$]al ,deposit ,insurance ,act 7#ab ,u4,s4,c4 #ahac74 7#c7 ,co/ ,! t]m co/ has ! mean+ giv5 to ! t]m co/ ( a loan gu>antee 9 section #ejb7e77;,c7 ( ! ,f$]al ,cr$it ,re=m ,act ( #aiij 7#b ,u4,s4,c4 #ffa;a7#e77;,c774 7#d7 ,depository in/itution2 depository in/itution hold+ company ,! t]m depository in/itution & depository in/itution hold+ company h ! mean+ giv5 ^? t]ms "u section #c ( ! ,f$]al ,deposit ,insurance ,act 7#ab ,u4,s4,c4 #ahac74 7#e7 ,eye bond ,! t]m eye bond means a bond-- 7,a7 issu$ by an issu] pursuant to ?is ,act2 7,b7 ! proce$s ( :i* are us$ to fund projects select$ "u section #f7;b77#a71 except z o!rwise describ$ 9 ?is ,act2 & 7,c7 t complies ) ! regulations issu$ "u section #d4 7#f7 ,fund$ project ,! t]m fund$ project means a translational rese>* project t is select$ to be fund$ us+ ! proce$s ( an eye bond4 7#g7 ,gu>antee ,! t]m gu>antee has ! mean+ giv5 to ! t]m loan gu>antee 9 section #ejb ( ! ,f$]al ,cr$it ,re=m ,act ( #aiij 7#b ,u4,s4,c4 #ffa;a7 & includes a loan gu>antee commitm5t 7z def9$ 9 su* section #ejb74 7#h7 ,issu] ,! t]m issu] means an entity t-- 7,a7 is a depository in/itution1 a depository in/itution hold+ company1 or a brok] or deal] regi/]$ ) ! ,securities & ,ex*ange ,commission2 7,b7 complies ) ! s*$ule = ! issuance ( eye bonds e/abli%$ "u section #c7;c72 & 7,c7 complies ) ! regulations issu$ "u section #e4 7#i7 ,program ,! t]m ,program means ! ,eye ,bond ,pilot ,program e/abli%$ "u section #c4 7#aj7 ,secret>y ,! t]m ,secret>y means ! ,secret>y ( ,heal? & ,human ,s]vices1 except 9 ref]5ces to ! ,secret>y ( ! ,treasury4 7#aa7 ,/ate ,! t]m ,/ate means-- 7,a7 ea* ,/ate ( ! ,unit$ ,/ates2 7,b7 ! ,di/rict ( ,columbia2 7,c7 ! ,commonweal? ( ,pu]to ,rico2 & 7,d7 any o!r t]ritory or possession ( ! ,unit$ ,/ates4 7#ab7 ,translational rese>* ,! t]m translational rese>*-- 7,a7 means any rese>* project t is design$ to cure vision bl9dness & any conditions att5dant to vision impairm5t t are1 z det]m9$ by ! ,director ( ! ,national ,eye ,in/itute1 cong5ital to ! vision impairm5t & n incid5tal to vision impairm5t or caus$ by vision impairm5t2 7,b7 includes projects design$ to cure-- 7i7 he>+ impairm5t g5etically l9k$ to vision impairm5t1 su* z ,u%] ,syndrome2 7ii7 ret9al deg5]ative diseases su* z ret9itis pigm5tosa1 macul> deg5]ation1 & ,u%] ,syndrome2 7iii7 vision trauma due to injury su* z t exp]i5c$ by w\nd$ vet]ans2 7iv7 glaucoma2 7v7 optic n]ve disord]s t result 9 vision impairm5t or bl9dness1 su* z morn+ glory syndrome2 & 7vi7 diabetic re9opa?y2 & 7,c7 subject to subp>agraph 7,b77vi71 does n include projects design$ to cure any und]ly+ disease or condition ^: symptoms may include vision impairm5t1 su* z diabetes4 #c4 ,eye ,bond ,pilot ,program 7a7 ,e/abli%m5t ,n e>li] ?an #a ye> aft] ! date ( enactm5t ( ?is ,act1 ! ,secret>y1 9 consultation ) ! ,secret>y ( ! ,treasury & ! appropriate ,f$]al bank+ ag5cies1 %all e/abli% a pilot program to be kn[n z ! ,eye ,bond ,pilot ,program "u :i*-- 7#a7 ! ,director ( ! ,national ,eye ,in/itute %all1 9 accordance ) section #f1 select translational rese>* projects to be fund$ by eye bonds2 & 7#b7 ! ,secret>y %all-- 7,a7 provide a p>tial ,f$]al gu>antee ( ! eye bonds2 7,b7 contract ) an issu] to issue ! eye bonds2 & 7,c7 use ! proce$s f ! sale ( ! eye bonds to fund ! select$ projects & to pay = o!r relat$ exp5ses1 z p]mitt$ by ?is ,act4 7b7 ,f$]al gu>antee 7#a7 ,9 g5]al ,! ,secret>y %all gu>antee ! paym5t ( pr9cipal 7b n ! paym5t ( int]e/7 on an eye bond1 on a bond-by-bond basis1 9 an am\nt to be det]m9$ by ! ,secret>y1 b 9 no case may ! am\nt ( su* gu>antee be m ?an #ej p]c5t ( ! pr9cipal ( ! eye bond4 7#b7 ,prioritization ( taxpay] int]e/s ,all eye bonds %all be /ructur$ to give fir/ priority to protect+ ! int]e/s ( ! ,unit$ ,/ates by ensur+ t-- 7,a7 all ca% proce$s receiv$ f ! repaym5t ( an eye bond are fir/ us$ to r$uce ! am\nt ( pr9cipal gu>ante$ by ! ,secret>y "u ! t]ms ( ! eye bond2 & 7,b7 ! ,secret>y has a s5ior claim on all assets & collat]al "u ! eye bond to ! ext5t ! gu>antee provid$ by ! ,secret>y is n ext+ui%$4 7#c7 ,limitation ,! ,secret>y may n gu>antee-- 7,a7 m ?an #a1jjj1jjj1jjj = all eye bonds issu$ pursuant to ?is ,act2 & 7,b7 m ?an #bej1jjj1jjj = all eye bonds issu$ pursuant to ?is ,act 9 any s+le fiscal ye>4 7c7 ,issuance s*$ule ,! ,secret>y %all1 9 consultation ) ! ,secret>y ( ! ,treasury & issu]s1 e/abli% a s*$ule = ! issuance ( eye bonds t ensures t fund$ projects repres5t a reasonable sample ( div]se causes ( vision loss4 7d7 ,risk-,%>e pool 7#a7 ,9 g5]al ,) respect to an eye bond gu>ante$ "u ?is section1 ! ,secret>y may all[ a risk-%>e pool capitaliz$ by issu]s to provide a fir/-loss gu>antee ( ! pr9cipal & int]e/ ( su* bond1 if ! ,secret>y det]m9es t su* fir/-loss gu>antee w\ld-- 7,a7 be a robu/ s\rce ( protection = ! ,unit$ ,/ates1 z gu>antor ( ! eye bond1 t r$uces ! co/ ( ! ,f$]al gu>antee to ! ,unit$ ,/ates2 7,b7 enc\rage ! fl[ ( private sector capital into biom$ical translational rese>*2 7,c7 create a prud5t inc5tive = issu]s to contribute additional private capital = biom$ical translational rese>*2 or 7,d7 meet o!r public int]e/1 safety1 & s\ndness goals4 7#b7 ,consultation ,9 mak+ a det]m9ation "u p>agraph 7#a71 ! ,secret>y %all consult ) ! ,secret>y ( ! ,treasury & ! appropriate ,f$]al bank+ ag5cies4 7#c7 ,fund+ ,! co/ ( contract+ ) a risk-%>e pool "u ?is subsection %all be paid f ! proce$s f ! sale ( eye bonds pursuant to ! ,program4 7e7 ,equity position option = ! ,secret>y 7#a7 ,9 g5]al ,) respect to an eye bond issu$ pursuant to ?is ,act1 ! ,secret>y1 9 consultation ) ! ,secret>y ( ! ,treasury & o!r appropriate p>ties1 includ+ eye bond issu]s & inve/ors1 may negotiate an equity position = ! ,unit$ ,/ates ,gov]nm5t 9 ! projects to be fund$ by su* eye bond if ! ,secret>y det]m9es t su* an equity position w fur!r ! int]e/s ( ! ,program & ! ,unit$ ,/ates4 7#b7 ,limitations 7,a7 ,supplem5tal ,any equity position tak5 9 a project pursuant to p>agraph 7#a7 %all be supplem5tal to1 n 9 lieu (1 a gu>antee provid$ by ! ,secret>y ) respect to ! eye bond fund+ su* project4 7,b7 ,total am\nt ,! total ( am\nt ( an eye bond gu>antee "u ?is section & any equity position tak5 by ! ,secret>y 9 a project fund$ by su* bond t is supplem5tal to su* gu>antee %all n exce$ #ej p]c5t ( ! pr9cipal am\nt ( ! eye bond4 7#c7 ,notification & consultation ,prior to f9alization ( any equity position "u p>agraph 7#a71 ! ,secret>y %all notify ! applicable congressional committees & consult ) su* committees on ! propos$ t]ms ( su* equity position & :e!r tak+ su* equity position w fur!r ! int]e/s ( ! ,program & ! ,unit$ ,/ates4 7f7 ,t]m9ation ( ! program 7#a7 ,9 g5]al ,except z provid$ 9 p>agraph 7#b71 ! ,program %all t]m9ate on ! date t is #f ye>s aft] ! date ( enactm5t ( ?is ,act4 7#b7 ,e>ly t]m9ation 7,a7 ,9 g5]al ,! ,secret>y may t]m9ate ! ,program be=e ! date describ$ 9 p>agraph 7#a74 7,b7 ,congressional notification ,if ! ,secret>y det]m9es t ! ,program %all be t]m9at$ "u subp>agraph 7,a71 n lat] ?an #fj days be=e ! date on :i* ! t]m9ation is effective1 ! ,secret>y %all-- 7i7 submit to ! applicable congressional committees a report t includes-- 7,i7 a description ( ! reasons = ! t]m9ation2 7,,ii7 any corrective actions t may be tak52 & 7,,iii7 any o!r actions t may be tak5 to promote ! use ( private capital & to increase ! am\nt ( ,f$]al funds made available to c>ry out basic & translational biom$ical rese>*2 & 7ii7 make publicly available ! report describ$ 9 clause 7i74 7#c7 ,effect on eye bonds issu$ & ,f$]al gu>antees ,! t]m9ation ( ! ,program %all n affect ! validity (-- 7,a7 any eye bond issu$ be=e ! date on :i* ! ,program is t]m9at$2 or 7,b7 any ,f$]al gu>antee "u ?is ,act = an eye bond describ$ 9 subp>agraph 7,a74 7g7 ,program fund+ 7#a7 ,adm9i/rative exp5ses paid f bond sales ,except z provid$ "u p>agraph 7#b71 ! co/ ( c>ry+ out ?is ,act1 includ+ ! co/ to ! ,secret>y 9 adm9i/]+ ! ,program1 %all be recov]$ f ! proce$s f ! sale ( eye bonds pursuant to ! ,program or f fees z set =? 9 p>agraph 7#c74 7#b7 ,specific appropriation or contribution ,no gu>antee %all be made "u ?is section unless-- 7,a7 an appropriation = ! full co/ ( ! gu>antee has be5 made2 7,b7 ! ,secret>y has receiv$ f ! eye bond issu] a paym5t 9 full = ! co/ ( ! gu>antee2 or 7,c7 a comb9ation ( an appropriation & ! deposit ( a paym5t f ! bond issu] into ! ,treasury has be5 made 9 a suffici5t am\nt to cov] ! full co/ ( ! gu>antee4 7#c7 ,co/ ( ,gu>antees 7,a7 ,9 g5]al ,! ,secret>y %all *>ge & collect fees = gu>antees "u ?is section 9 am\nts ! ,secret>y det]m9es are suffici5t to recov] applicable adm9i/rative exp5ses4 7,b7 ,availability ,fees collect$ "u ?is subsection-- 7i7 %all be deposit$ by ! ,secret>y into ! ,treasury2 & 7ii7 are au?oriz$ to rema9 available until exp5d$4 #d4 ,eye bond t]ms1 conditions1 & /ructure 7a7 ,9 g5]al ,n lat] ?an #ahj days aft] ! date ( enactm5t ( ?is ,act1 ! ,secret>y1 9 consultation ) ! ,secret>y ( ! ,treasury1 ! ,*airman ( ! ,securities & ,ex*ange ,commission1 ! heads ( ! appropriate ,f$]al bank+ ag5cies1 ! ,director ( ! ,national ,in/itutes ( ,heal?1 & ! heads ( o!r ,f$]al dep>tm5ts & ag5cies & o!r int]e/$ p>ties z ! ,secret>y det]m9es appropriate1 %all issue regulations to specify ! t]ms1 conditions1 & /ructure = an eye bond4 7b7 ,auctions ,9 issu+ ! regulations "u subsection 7a7-- 7#a7 ! ,secret>y may provide = an auction to select ! pur*as]s ( eye bonds2 & 7#b7 any su* auction may include a process t m9imizes ! risk to ! ,gov]nm5t ( ! ,f$]al gu>antee involv$ by all[+ bidd]s = an eye bond to compete aga9/ ea* o!r by bidd+ on ! p]c5tage ( ! ,f$]al gu>antee "u section #d7;b7 ) respect to ! eye bond1 ) ! bid = ! l[e/ p]c5tage w9n+ ! auction1 tak+ into acc\nt o!r t]ms & conditions set by ! issu] to ensure ! l[e/ total co/ to ! ,gov]nm5t4 #e4 ,eye bond issu]s 7a7 ,issu] crit]ia ,n lat] ?an #ahj days aft] ! date ( enactm5t ( ?is ,act1 ! ,secret>y1 9 consultation ) ! ,secret>y ( ! ,treasury1 %all issue regulations-- 7#a7 to e/abli% ! crit]ia = select+ issu]s2 7#b7 to ensure t issu]s p]=m 9 a mann] t ensures ! successful issuance ( eye bonds t promote biom$ical translational rese>* 9 ! ,unit$ ,/ates2 & 7#c7 to ensure t issu]s use s\nd und]writ+ practices t protect ! int]e/s (-- 7,a7 ! ,unit$ ,/ates2 7,b7 eye bond inve/ors2 & 7,c7 ! long-t]m promotion ( translational rese>* = vision impairm5t & o!r diseases1 disabilities1 & syndromes cong5ital to vision impairm5t or caus$ by vision impairm5t1 tak+ into acc\nt features t are valuable aft] any au?orization = exp&$ use ( a limit$ ,f$]al gu>antee = biom$ical translational rese>* = o!r diseases & disabilities4 7b7 ,comp5sation = issu]s ,! issu] ( an eye bond %all be comp5sat$ f ! proce$s f ! sale ( su* eye bond at su* rate & on su* t]ms z ! ,secret>y may provide4 7c7 ,public disclosures ) respect to eye bonds 7#a7 ,9 g5]al ,n less ?an #b bus9ess days be=e ! date on :i* an issu] issues an eye bond1 ! issu] %all file ) ! ,securities & ,ex*ange ,commission1 & make available to ! public1 ! foll[+ in=mation3 7,a7 ,! nature ( all projects fund$ by ! eye bond4 7,b7 ,! "n ( any pr9cipal individual or in/itution t w be conduct+ ea* project4 7,c7 ,! mile/ones e/abli%$ = ea* project4 7,d7 ,a det]m9ation by ! issu] z to :e!r ea* project fund$ by ! eye bond has appropriately protect$ intellectual prop]ty4 7,e7 ,! /ructure ( ! eye bond4 7,f7 ,! int]e/ paym5t s*$ule = ! eye bond4 7,g7 ,! anticipat$ returns & risks ( ! eye bond4 7,h7 ,su* o!r in=mation z ! ,commission det]m9es necess>y or appropriate 9 ! public int]e/ or = ! protection ( inve/ors4 7#b7 ,rulemak+ 7,a7 ,9 g5]al ,n lat] ?an #ahj days aft] ! date ( enactm5t ( ?is ,act1 ! ,securities & ,ex*ange ,commission %all issue regulations to c>ry out ?is subsection4 7,b7 ,au?ority ( ! ,secret>y ,if ! ,securities & ,ex*ange ,commission does n issue ! regulations requir$ "u subp>agraph 7,a7 be=e ! end ( ! #ahj-;day p]iod describ$ "u subp>agraph 7,a71 ! ,secret>y %all issue regulations to c>ry out ?is subsection be=e ! end ( ! #fj-;day p]iod beg9n+ on ! end ( ! #ahj-;day p]iod describ$ "u subp>agraph 7,a74 #f4 ,translational rese>* projects 7a7 ,eligibility requirem5ts ,n lat] ?an #ahj days aft] ! date ( enactm5t ( ?is ,act1 ! ,secret>y1 9 consultation ) ! ,secret>y ( ! ,treasury1 ! ,director ( ! ,national ,eye ,in/itute1 & o!r int]e/$ p>ties1 %all issue f9al regulations = ! eligibility crit]ia = select+ translational rese>* projects t w be fund$ ?r\gh eye bonds4 ,su* regulations %all address-- 7#a7 ! /age ( cl9ical trial = projects to provide ! greate/ likelihood ( comm]cial application2 7#b7 ! v>iations among disease & conditions ne$$ to ensure suffici5t div]sification 9 ea* eye bond2 & 7#c7 ! numb] ( possible cures & treatm5ts t are ne$$ z det]m9$ by ! ,secret>y1 9 consultation ) issu]s & ! ,director ( ! ,national ,eye ,in/itute1 to ensure ! successful issuance ( eye bonds s z to protect ! ,unit$ ,/ates z gu>antor ( ! eye bonds1 includ+-- 7,a7 drug !rapies2 7,b7 g5e !rapies2 & 7,c7 artificial re/oration ( sight & simil> me*anisms4 7b7 ,selection ( projects 7#a7 ,9 g5]al ,! ,director ( ! ,national ,eye ,in/itute1 9 consultation ) ! ,director ( ! ,national ,in/itutes ( ,heal? & ! ,secret>y ( ! ,treasury1 %all select translational rese>* projects to be fund$ ) ! proce$s ( an eye bond4 7#b7 ,factors = selection ,n lat] ?an #cj days aft] ! date on :i* ! f9al regulations are issu$ "u subsection 7a71 ! ,secret>y %all submit to ! ,director ( ! ,national ,eye ,in/itute factors t ! ,director ( ! ,national ,eye ,in/itute %all consid] 9 mak+ ! selection "u p>agraph 7#a71 includ+-- 7,a7 ! am\nt ( equity any intellectual prop]ty hold] w hold 9 ! project2 7,b7 ! res\rces any individual or in/itution w be requir$ to demon/rate to ensure ! ability ( ! individual or in/itution to repay ! obligation "u ! eye bond1 reg>dless ( ! success or failure ( ! project fund$ ) ! proce$s ( ! eye bond2 7,c7 ! numb] ( projects ne$$ to ensure div]sification ( risk2 7,d7 ! mann] 9 :i* fund$ projects w be defund$ if ! int]im goals ( ! project are n satisfi$2 & 7,e7 su* o!r factors relat$ to biom$ical translational rese>* project selection z ! ,secret>y det]m9es appropriate4 7#c7 ,additional consultations 7,a7 ,9 g5]al ,9 c>ry+ out p>agraph 7#a71 ! ,director ( ! ,national ,eye ,in/itute may e/abli% any consultative body t ! ,director det]m9es is necess>y to provide = a complete1 transp>5t1 & =w>d-look+ selection ( projects4 7,b7 ,sci5tific advis]s ,9 c>ry+ out p>agraph 7#a71 ! ,director ( ! ,national ,eye ,in/itute may consult ) any gr\p ( sci5tific advis]s t ! ,director det]m9es is necess>y4 7c7 ,e/abli%m5t ( mile/ones 7#a7 ,9 g5]al ,! ,director ( ! ,national ,eye ,in/itute %all1 = ea* project fund$ by an eye bond1 e/abli% mile/ones to det]m9e ! probability ( success or failure = su* project4 7#b7 ,inclusion 9 fil+s ,! ,director ( ! ,national ,eye ,in/itute %all submit to ! issu] ( an eye bond ! mile/ones = ea* project fund$ f su* eye bond1 s su* mile/ones may be includ$ 9 ! fil+s made available by ! issu] to ! public "u section #e7;c74 7d7 ,rese>* requirem5t ,translational rese>* c>ri$ out "u a project fund$ by an eye bond %all be conduct$-- 7#a7 9 a ,/ate2 & 7#b7 by an individual or in/itution t is-- 7,a7 *>t]$ 9 accordance ) ! laws ( t ,/ate2 & 7,b7 cle>ly subject to v]ification ( b5eficial own]%ip by ! issu] &1 ^u reque/1 by ! ,secret>y4 #g4 ,inapplicability ( c]ta9 laws ,eye bonds %all n be subject to-- 7#a7 section #ae;,g ( ! ,securities ,ex*ange ,act ( #aicd 7#ae ,u4,s4,c4 #gho-#aa72 7#b7 except z provid$ "u section #e7;c71 any regi/ration or disclosure requirem5t promulgat$ by ! ,securities & ,ex*ange ,commission2 & 7#c7 section #ac ( ! ,bank ,hold+ ,company ,act ( #aief 7#ab ,u4,s4,c4 #ahea74 #h4 ,reports 7a7 ,,gao /udy & reports on o!r rese>* projects 7#a7 ,ongo+ /udy ,! ,comptroll] ,g5]al ( ! ,unit$ ,/ates %all c>ry out an ongo+ /udy to consid] :e!r a program simil> to ! ,eye ,bond ,pilot ,program "u ?is ,act %\ld be e/abli%$ = o!r biom$ical rese>* projects4 7#b7 ,report ,! ,comptroll] ,g5]al %all1 dur+ ! p]iod beg9n+ on ! date ( ! e/abli%m5t ( ! ,program & end+ on ! t]m9ation date ( ! ,program1 issue a report to ! applicable congressional committees1 n less frequ5tly ?an annually1 on all f9d+s & det]m9ations made 9 c>ry+ out ! /udy requir$ "u p>agraph 7#a74 7b7 ,reports on ! ,program ,n lat] ?an #b ye>s aft] ! date on :i* eye bonds are fir/ issu$ "u ?is ,act1 & annually !reaft] dur+ ! p]iod end+ on ! date t is #d ye>s aft] ! date on :i* eye bonds are fir/ issu$ "u ?is ,act1 ! ,comptroll] ,g5]al & ! ,director ( ! ,national ,in/itutes ( ,heal? 79 consultation ) ! ,director ( ! ,national ,c5t] = ,advanc+ ,translational ,sci5ces7 %all ea* issue a sep>ate report to ! applicable congressional committees on-- 7#a7 ! progress ( ! issuance ( eye bonds2 7#b7 ! reasons = any problems a*iev+ desir$ volumes ( eye bonds or ! ability ( ! ,program to proce$ at a fa/] pace2 7#c7 an analysis ( ! risk to ! ,gov]nm5t 9 provid+ ! ,f$]al gu>antee describ$ "u section #d7;b72 7#d7 any improvem5ts to eye bonds t ! ,secret>y %\ld consid]2 7#e7 ! applicability ( f9ancial in/rum5ts simil> to eye bonds to o!r biom$ical rese>* areas su* z canc]1 ,alzheim]'s disease1 r>e diseases or conditions 7z def9$ 9 section #ebf ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;bb77 & syndromes ( p>ticul> conc]n to *ildr52 & 7#f7 any o!r matt] t ! ,comptroll] ,g5]al or ! ,director1 respectively1 det]m9es is appropriate4