,i #aaf? ,,congress #a/ ,session ,h4 ,r4 #abji ,,9 ,,! ,,h\se ,,( ,,repres5tatives ,febru>y #ac1 #bjai,ms4 ,roybal-,all>d 7= h]self & ,mr4 ,calv]t7 introduc$ ! foll[+ bill2 :i* 0 ref]r$ to ! ,committee on ,en]gy & ,comm]ce ,a ,,bill ,to am5d ! ,public ,heal? ,s]vice ,act to ensure t non-animal me?ods are prioritiz$1 :]e applicable & feasible1 9 proposals = all rese>* to be conduct$ or support$ by ! ,national ,in/itutes ( ,heal?1 & = o!r purposes4 #a4 ,%ort title ,?is ,act may be cit$ z ! ,humane & ,exi/+ ,alt]natives 9 ,rese>* & ,te/+ ,sci5ces ,act ( #bjai or ! ,,he>ts ,act ( #bjai4 #b4 ,f9d+s ,congress f9ds ! foll[+3 7#a7 ,! ,national ,in/itutes ( ,heal? has support$ life-sav+ rese>* t has greatly improv$ ! heal? & well-be+ n only ( ,am]icans b also ( p ar\nd ! _w4 7#b7 ,mu* ( ?is rese>* has reli$ on animals4 ,x is e/imat$ t betwe5 #ag million & #bb million animals are us$ annually 9 ! ,unit$ ,/ates 9 rese>*1 education1 & te/+4 7#c7 ,at ! same "t1 h[ev]1 a great deal ( rese>* t utiliz$ animal /udies yield$ no b5efits = humans4 ,= example1 accord+ to ,,nih itself1 approximately #cj p]c5t ( promis+ m$ications h fail$ 9 human cl9ical trials because !y are f\nd to be toxic despite promis+ pre-cl9ical /udies 9 animal models4 ,ab\t #fj p]c5t ( c&idate drugs fail due to lack ( efficacy4 7#d7 ,! laboratory use ( animals has also long be5 an issue ( public conc]n because animals w1 9 mo/ cases1 exp]i5ce fe>1 pa91 disease or surg]y1 & e>ly dea?4 7#e7 ,mu* m has become kn[n ab\t ! unsuitability ( animal models = /udy+ human disease & _m m humane1 co/-effective1 & sci5tifically suitable non-animal me?ods are available4 7#f7 ,"u ! sy/em ( ov]sight e/abli%$ by ! ,animal ,welf>e ,act 7,public ,law #hi-edd71 rese>*]s are suppos$ to consid] alt]natives to animal use or pa9ful proc$ures & %\ld n unnecess>ily duplicate previ\s exp]im5ts4 ,h[ev]1 ov]sight is g5]ally weak & little he$ is paid to ! use ( non-animal me?ods or ! avoidance ( duplication1 !reby unnecess>ily subject+ animals to pa91 suff]+1 & dea?4 7#g7 ,a sy/em ( active inc5tives is ne$$ to enc\rage rese>*]s to utilize humane1 co/-effective1 & sci5tifically suitable non-animal me?ods4 #c4 ,animals 9 rese>* ,section #die ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bhi;d7 is am5d$ to read z foll[s3 #die4 ,animals 9 rese>* 7a7 ,9 g5]al ,! ,secret>y1 act+ ?r\gh ! ,director ( ,,nih1 %all1 ) respect to all rese>* conduct$ or support$ by ! ,national ,in/itutes ( ,heal?1 d ! foll[+3 7#a7 ,e/abli% a sy/em ( mean+ful inc5tives to enc\rage ! use ( exi/+ humane & sci5tifically satisfactory non-animal me?ods 9 rese>* proposals4 7#b7 ,ensure t1 be=e any rese>* involv+ ! use ( animals is approv$ or p]=m$-- 7,a7 all sci5tifically satisfactory non-animal me?ods = obta9+ ! results s\ght h be5 fully evaluat$2 & 7,b7 a detail$ explanation & an analysis ( ! h>ms & b5efits ( su* use ( animals h be5 complet$4 7#c7 ,ensure t-- 7,a7 rese>* proposals are review$ by at lea/ "o p]son :o has exp]tise 9 non-animal rese>* me?ods2 & 7,b7 review]s ( ! rese>* proposals h access to a ref]5ce libr>ian ) exp]tise 9 evaluat+ ! adequacy ( ! se>*es = non-animal me?ods describ$ 9 ! rese>* proposals4 7#d7 ,e/abli% & ma9ta9 rese>* proposal guidel9es = ! foll[+3 7,a7 ,conduct+ ?or\gh se>*es = non-animal alt]natives to ! use ( animals = biom$ical & behavioral rese>*4 7,b7 ,c>ry+ out analyses ( ! h>ms & b5efits ( ! use ( animals 9 propos$ rese>* to assess :e!r ! h>ms t w\ld be caus$ to animals 9 t]ms ( suff]+1 pa91 & di/ress are ju/ifi$ by ! expect$ outcomes1 tak+ into acc\nt e?ical consid]ations & ! expect$ b5efits to human be+s1 animals1 or ! environm5t4 7#e7 ,e/abli% & ma9ta9 animal c>e guidel9es = ! foll[+3 7,a7 ,! prop] c>e ( animals to be us$ 9 biom$ical & behavioral rese>*4 7,b7 ,! prop] treatm5t ( animals :ile be+ us$ 9 su* rese>*4 ,guidel9es "u ?is p>agraph %all require-- 7i7 ! appropriate use ( tranquiliz]s1 analgesics1 ane/hetics1 p>alytics1 & eu?anasia = animals 9 su* rese>*2 & 7ii7 appropriate pre-surgical & po/-surgical vet]9>y m$ical & nurs+ c>e = animals 9 su* rese>*4 ,su* guidel9es %all n be con/ru$ to prescribe me?ods ( rese>*4 7,c7 ,! organization & op]ation ( animal c>e committees 9 accordance ) subsection 7b74 7b7 ,animal c>e committees 7#a7 ,9 g5]al ,! guidel9es "u subsection 7a77#e77;,c7 %all require animal c>e committees at ea* entity :i* conducts biom$ical & behavioral rese>* ) funds provid$ "u ?is ,act 7includ+ ! ,national ,in/itutes ( ,heal? & ! national rese>* in/itutes7 to assure compliance ) ! guidel9es e/abli%$ "u subsection 7a77#e74 7#b7 ,appo9tm5t ( memb]s ,ea* animal c>e committee %all-- 7,a7 be appo9t$ by ! *ief executive (fic] ( ! entity = :i* ! committee is e/abli%$2 7,b7 be compos$ ( n few] ?an ?ree memb]s2 & 7,c7 include at lea/ "o individual :o has no association ) su* entity & at lea/ "o doctor ( vet]9>y m$ic9e4 7#c7 ,requirem5ts ,ea* animal c>e committee ( a rese>* entity %all-- 7,a7 review ! c>e & treatm5t ( animals 9 all animal /udy areas & facilities ( ! rese>* entity at lea/ semiannually to evaluate compliance ) applicable guidel9es e/abli%$ "u subsection 7a77#e7 = appropriate animal c>e & treatm5t2 7,b7 keep appropriate records ( reviews conduct$ "u subp>agraph 7,a72 & 7,c7 = ea* review conduct$ "u subp>agraph 7,a71 file ) ! ,director ( ,,nih at lea/ annually-- 7i7 a c]tification t ! review has be5 conduct$2 & 7ii7 reports ( any violations ( ! guidel9es "u subsection 7a77#e7 or assurances requir$ "u p>agraph 7#a7 :i* 7 obs]v$ 9 su* review & :i* h cont9u$ aft] notice by ! committee to ! rese>* entity involv$ ( ! violations4 7#d7 ,m9ority views ,reports fil$ "u p>agraph 7#c77;,c7 %all include any m9ority views fil$ by memb]s ( ! committee4 7c7 ,applications & contracts 7#a7 ,cont5ts ,! ,director ( ,,nih %all require ea* applicant = a grant1 contract1 or coop]ative agreem5t involv+ rese>* on animals :i* is adm9i/]$ by ! ,national ,in/itutes ( ,heal? or any national rese>* in/itute to include 9 its application or contract proposal-- 7,a7 assurances satisfactory to ! ,director ( ,,nih t-- 7i7 ! applicant meets ! requirem5ts "u p>agraphs 7#b71 7#c71 7#d71 & 7#e7 ( subsection 7a7 & has an animal c>e committee :i* meets ! requirem5ts ( subsection 7b72 & 7ii7 sci5ti/s1 animal te*nicians1 & o!r p]sonnel involv$ ) animal c>e1 treatm5t1 & use by ! applicant h available to !m in/ruction or tra9+ 9-- 7,i7 ! humane practice ( animal ma9t5ance & exp]im5tation2 & 7,,ii7 ! concept1 availability1 & use ( rese>* or te/+ me?ods t replace ! use ( animals1 limit ! use ( animals1 or limit animal di/ress2 7,b7 a /atem5t ( ! reasons = ! use ( animals 9 ! rese>* to be conduct$ ) funds provid$ "u su* grant or contract2 7,c7 a /atem5t ( assurance t a sci5tifically satisfactory non-animal me?od ( obta9+ ! result s\ght is n available2 & 7,d7 an analysis ( ! h>ms & b5efits ( ! use ( animals 9 ! propos$ rese>* assess+ :e!r ! h>ms t w\ld be caus$ to animals 9 t]ms ( suff]+1 pa91 & di/ress is ju/ifi$ by ! expect$ outcomes1 tak+ into acc\nt e?ical consid]ations & ! expect$ b5efits to human be+s1 animals1 or ! environm5t4 7#b7 ,regulatory process ,not)/&+ subsection 7a77#b7 ( section #eec ( title #e1 ,unit$ ,/ates ,code1 regulations "u ?is subsection %all be promulgat$ 9 accordance ) ! notice & comm5t requirem5ts ( su* section4 7d7 ,susp5sion or revocation ,if ! ,director ( ,,nih det]m9es t-- 7#a7 ! conditions ( animal c>e1 treatm5t1 or use 9 an entity :i* is receiv+ a grant1 contract1 or coop]ative agreem5t involv+ rese>* on animals "u ?is title d n meet applicable guidel9es e/abli%$ "u subsection 7a77#e72 7#b7 ! entity has be5 notifi$ by ! ,director ( ,,nih ( su* det]m9ation & has be5 giv5 a reasonable opportunity to take corrective action2 & 7#c7 no action has be5 tak5 by ! entity to correct su* conditions1 ! ,director ( ,,nih %all susp5d or revoke su* grant1 contract1 or coop]ative agreem5t "u su* conditions z ! ,director det]m9es appropriate4 7e7 ,protection ( c]ta9 in=mation ,no guidel9e or regulation promulgat$ "u subsection 7a77#e7 or 7c7 may require a rese>* entity to disclose publicly trade secrets or comm]cial or f9ancial in=mation :i* is privileg$ or confid5tial4 4