,,ii #aah? ,,congress #a/ ,session ,s4 #ahdd ,,9 ,,! ,,s5ate ,,( ,,! ,,unit$ ,,/ates ,june #g1 #bjbc,ms4 ,baldw9 7= h]self & ,mr4 ,mull97 introduc$ ! foll[+ bill2 :i* 0 read twice & ref]r$ to ! ,committee on ,heal?1 ,education1 ,labor1 & ,p5sions ,a ,,bill ,to am5d ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act to reau?orize us] fee programs relat+ to new animal drugs & g5]ic new animal drugs4 #a4 ,%ort title ,?is ,act may be cit$ z ! ,animal ,drug & ,animal ,g5]ic ,drug ,us] ,fee ,am5dm5ts ( #bjbc4 #b4 ,table ( cont5ts ,! table ( cont5ts = ?is ,act is ! foll[+3 ,sec4 #a4 ,%ort title4,sec4 #b4 ,table ( cont5ts4,,title ,i--,fees ,relat+ to ,animal ,drugs,sec4 #aja4 ,%ort title2 f9d+4,sec4 #ajb4 ,def9itions4,sec4 #ajc4 ,au?ority to assess & use animal drug fees4,sec4 #ajd4 ,reau?orization2 report+ requirem5ts4,sec4 #aje4 ,sav+s clause4,sec4 #ajf4 ,effective date4,sec4 #ajg4 ,sunset dates4,,title ,,ii--,fees ,relat+ to ,g5]ic ,animal ,drugs,sec4 #bja4 ,%ort title2 f9d+4,sec4 #bjb4 ,au?ority to assess & use g5]ic new animal drug fees4,sec4 #bjc4 ,reau?orization2 report+ requirem5ts4,sec4 #bjd4 ,sav+s clause4,sec4 #bje4 ,effective date4,sec4 #bjf4 ,sunset dates4,,title ,,iii--,support+ ,animal & ,human ,health,sec4 #cja4 ,report+ requirem5ts4,sec4 #cjb4 ,def9ition ( major species4,sec4 #cjc4 ,antimicrobial resi/ance4 ,i ,fees ,relat+ to ,animal ,drugs #aja4 ,%ort title2 f9d+ 7a7 ,%ort title ,?is title may be cit$ z ! ,animal ,drug ,us] ,fee ,am5dm5ts ( #bjbc4 7b7 ,f9d+ ,congress f9ds t ! fees au?oriz$ by ! am5dm5ts made 9 ?is title w be d$icat$ t[>d exp$it+ ! animal drug developm5t process & ! review ( new & supplem5tal animal drug applications & inve/igational animal drug submissions z set =? 9 ! goals id5tifi$ = purposes ( "p #d ( sub*apt] ,c ( *apt] ,,vii ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;j-#aa et seq471 9 ! lett]s f ! ,secret>y ( ,heal? & ,human ,s]vices to ! ,*airman ( ! ,committee on ,en]gy & ,comm]ce ( ! ,h\se ( ,repres5tatives & ! ,*airman ( ! ,committee on ,heal?1 ,education1 ,labor1 & ,p5sions ( ! ,s5ate z set =? 9 ! ,congressional ,record4 #ajb4 ,def9itions ,section #gci ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;j-#aa7 is am5d$-- 7#a7 9 p>agraph 7#c71 by /rik+ national drug code & ins]t+ ,national ,drug ,code2 & 7#b7 by am5d+ p>agraph 7#h77;,i7 to read z foll[s3 7,i7 ,! activities necess>y = implem5tation ( ! ,unit$ ,/ates & ,european ,union ,mutual ,recognition ,agreem5t = ,ph>maceutical ,good ,manufactur+ ,practice ,inspections1 & ! ,unit$ ,/ates & ,unit$ ,k+dom ,mutual ,recognition ,agreem5t ,sectoral ,annex = ,ph>maceutical ,good ,manufactur+ ,practices1 & o!r mutual recognition agreem5ts1 ) respect to animal drug products subject to review1 includ+ implem5tation activities prior to & foll[+ product approval4 4 #ajc4 ,au?ority to assess & use animal drug fees 7a7 ,9 g5]al ,section #gdj7;a77#a77;,a77ii7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;j-#ab7;a77#a77;,a77ii77 is am5d$-- 7#a7 9 subclause 7,i71 by /rik+ & at ! end2 7#b7 9 subclause 7,,ii71 by /rik+ ! p]iod at ! end & ins]t+ 2 &2 & 7#c7 by add+ at ! end ! foll[+3 7,,iii7 an application = conditional approval "u section #ega ( a new animal drug = :i* an animal drug application submitt$ "u section #eab7;b77#a7 has be5 previ\sly approv$ "u section #eab7;d77#a7 = ano!r int5d$ use4 4 7b7 ,fee rev5ue am\nts ,section #gdj7;b77#a7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;j-#ab7;b77#a77 is am5d$ to read z foll[s3 7#a7 ,9 g5]al ,subject to subsections 7c71 7d71 7f71 & 7g71 = ea* ( fiscal ye>s #bjbd ?r\gh #bjbh1 ! fees requir$ "u subsection 7a7 %all be e/abli%$ to g5]ate a total rev5ue am\nt ( #cc1ejj1jjj4 4 7c7 ,annual fee sett+2 adju/m5ts 7#a7 ,annual fee sett+ ,section #gdj7;c77#a7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;j-#ab7;c77#a77 is am5d$ to read z foll[s3 7#a7 ,annual fee sett+ ,n lat] ?an #fj days be=e ! />t ( ea* fiscal ye> beg9n+ aft] ,septemb] #cj1 #bjbc1 ! ,secret>y %all-- 7,a7 e/abli% = t fiscal ye> animal drug application fees1 supplem5tal animal drug application fees1 animal drug sponsor fees1 animal drug e/abli%m5t fees1 & animal drug product fees bas$ on ! rev5ue am\nts e/abli%$ "u subsection 7b7 & ! adju/m5ts provid$ "u ?is subsection2 & 7,b7 publi% su* fee rev5ue am\nts & fees 9 ! ,f$]al ,regi/]4 4 7#b7 ,inflation adju/m5t ,section #gdj7;c77#b7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;j-#ab7;c77#b77 is am5d$-- 7,a7 9 subp>agraph 7,a7-- 7i7 9 ! matt] prec$+ clause 7i71 by /rik+ #bjbj & ins]t+ #bjbe2 & 7ii7 9 clause 7iii71 by /rik+ ,baltimore & ins]t+ ,arl+ton-,alex&ria2 & 7,b7 9 subp>agraph 7,b71 by /rik+ #bjbj & ins]t+ #bjbe4 7#c7 ,workload adju/m5ts ,section #gdj7;c77#c7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;j-#ab7;c77#c77 is am5d$-- 7,a7 9 subp>agraph 7,a7-- 7i7 9 ! matt] prec$+ clause 7i7-- 7,i7 by /rik+ #bjbj & ins]t+ #bjbe2 & 7,,ii7 by /rik+ subp>agraphs 7,b7 & 7,c7 & ins]t+ subp>agraph 7,b72 7ii7 9 clause 7i7 by /rik+ & at ! end2 & 7iii7 by /rik+ clause 7ii7 & ins]t+ ! foll[+3 7ii7 su* adju/m5t %all be made = ea* fiscal ye> t ! adju/m5t det]m9$ by ! ,secret>y is great] ?an #c p]c5t1 except = ! fir/ fiscal ye> t ! adju/m5t is great] ?an #c p]c5t2 & 7iii7 ! ,secret>y %all publi% 9 ! ,f$]al ,regi/] notice "u p>agraph 7#a7 ! am\nt ( su* adju/m5t & ! support+ me?odologies4 2 7,b7 by /rik+ subp>agraph 7,b72 & 7,c7 by r$esignat+ subp>agraph 7,c7 z subp>agraph 7,b74 7#d7 ,f9al ye> adju/m5t ,section #gdj7;c77#d7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;j-#ab7;c77#d77 is am5d$ to read z foll[s3 7#d7 ,op]at+ res]ve adju/m5t 7,a7 ,9 g5]al ,= fiscal ye> #bjbe & ea* subsequ5t fiscal ye>1 aft] ! fee rev5ue am\nt e/abli%$ "u subsection 7b7 is adju/$ 9 accordance ) p>agraphs 7#b7 & 7#c71 ! ,secret>y %all-- 7i7 increase ! fee rev5ue am\nt = su* fiscal ye>1 if necess>y to provide an op]at+ res]ve ( n less ?an #ab weeks2 or 7ii7 if ! ,secret>y has an op]at+ res]ve 9 excess ( ! numb] ( weeks specifi$ 9 subp>agraph 7,c7 = t fiscal ye>1 ! ,secret>y %all decrease ! fee rev5ue am\nt to provide n m ?an ! numb] ( weeks specifi$ 9 subp>agraph 7,c7 = t fiscal ye>4 7,b7 ,c>ryov] us] fees ,= purposes ( ?is p>agraph1 ! op]at+ res]ve ( c>ryov] us] fees = ! process = ! review ( animal drug applications does n include c>ryov] us] fees t h n be5 appropriat$4 7,c7 ,numb] ( weeks ( op]at+ res]ves ,! numb] ( weeks ( op]at+ res]ves specifi$ 9 ?is subp>agraph is-- 7i7 #bb weeks = fiscal ye> #bjbe2 7ii7 #bj weeks = fiscal ye> #bjbf2 7iii7 #ah weeks = fiscal ye> #bjbg2 & 7iv7 #af weeks = fiscal ye> #bjbh4 7,d7 ,publication ,if an adju/m5t to ! op]at+ res]ve is made "u ?is p>agraph1 ! ,secret>y %all publi% 9 ! ,f$]al ,regi/] notice "u p>agraph 7#a7 ! rationale = ! am\nt ( ! adju/m5t & ! support+ me?odologies4 4 7d7 ,exemption f fees ,section #gdj7;d77#d7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;j-#ab7;d77#d77 is am5d$ to read z foll[s3 7#d7 ,exemption f fees ,fees "u p>agraphs 7#b71 7#c71 & 7#d7 ( subsection 7a7 %all n apply ) respect to any p]son :o is ! nam$ applicant or sponsor ( an animal drug application1 supplem5tal animal drug application1 or inve/igational animal drug submission if su* application or submission involves ! int5tional g5omic alt]ation ( an animal t is int5d$ to produce a drug1 device1 or biological product subject to fees "u section #gcf1 #gch1 #gdd;,b1 or #gdd;,h4 4 7e7 ,cr$it+ & availability ( fees 7#a7 ,au?orization ( appropriations ,section #gdj7;g77#c7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;j-#ab7;g77#c77 is am5d$ by /rik+ #bjai ?r\gh #bjbc & ins]t+ #bjbd ?r\gh #bjbh4 7#b7 ,collection %ortfalls ,section #gdj7;g7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;j-#ab7;g77 is am5d$-- 7,a7 9 p>agraph 7#c71 by /rik+ & p>agraph 7#e72 & 7,b7 by /rik+ p>agraph 7#e74 #ajd4 ,reau?orization2 report+ requirem5ts ,section #gdj;,a ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;j-#ac7 is am5d$-- 7#a7 9 subsection 7a71 by /rik+ #bjah & ins]t+ #bjbc2 7#b7 by /rik+ #bjai ea* place x appe>s 9 subsections 7a7 & 7b7 & ins]t+ #bjbd2 & 7#c7 9 subsection 7d7-- 7,a7 9 p>agraph 7#a71 by /rik+ #bjbc & ins]t+ #bjbh2 & 7,b7 9 p>agraph 7#e71 by /rik+ #bjbc & ins]t+ #bjbh4 #aje4 ,sav+s clause ,not)/&+ ! am5dm5ts made by ?is title1 "p #d ( sub*apt] ,c ( *apt] ,,vii ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;j-#aa et seq471 z 9 effect on ! day be=e ! date ( enactm5t ( ?is title1 %all cont9ue to be 9 effect ) respect to animal drug applications & supplem5tal animal drug applications 7z def9$ 9 su* "p z ( su* day7 t on or aft] ,octob] #a1 #bjah1 b be=e ,octob] #a1 #bjbc1 7 accept$ by ! ,food & ,drug ,adm9i/ration = fil+ ) respect to assess+ & collect+ any fee requir$ by su* "p = a fiscal ye> prior to fiscal ye> #bjbd4 #ajf4 ,effective date ,! am5dm5ts made by ?is title %all take effect on ,octob] #a1 #bjbc1 or ! date ( ! enactm5t ( ?is ,act1 :i*ev] is lat]1 except t fees "u "p #d ( sub*apt] ,c ( *apt] ,,vii ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;j-#aa et seq471 z am5d$ by ?is title1 %all be assess$ = animal drug applications & supplem5tal animal drug applications receiv$ on or aft] ,octob] #a1 #bjbc1 reg>dless ( ! date ( ! enactm5t ( ?is ,act4 #ajg4 ,sunset dates 7a7 ,au?orization ,sections #gci & #gdj ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #ba ,u4,s4,c4 #cgi;j-#aa2 #cgi;j-#ab7 %all cease to be effective ,octob] #a1 #bjbh4 7b7 ,report+ requirem5ts ,section #gdj;,a ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;j-#ac7 %all cease to be effective ,janu>y #ca1 #bjbi4 7c7 ,previ\s sunset provision ,effective ,octob] #a1 #bjbc1 subsections 7a7 & 7b7 ( section #ajg ( ! ,animal ,drug ,us] ,fee ,am5dm5ts ( #bjah 7,public ,law #aae-bcd7 are repeal$4 ,,ii ,fees ,relat+ to ,g5]ic ,animal ,drugs #bja4 ,%ort title2 f9d+ 7a7 ,%ort title ,?is title may be cit$ z ! ,animal ,g5]ic ,drug ,us] ,fee ,am5dm5ts ( #bjbc4 7b7 ,f9d+ ,congress f9ds t ! fees au?oriz$ by ! am5dm5ts made 9 ?is title w be d$icat$ t[>d exp$it+ ! g5]ic new animal drug developm5t process & ! review ( abbreviat$ applications = g5]ic new animal drugs1 supplem5tal abbreviat$ applications = g5]ic new animal drugs1 & inve/igational submissions = g5]ic new animal drugs z set =? 9 ! goals id5tifi$ = purposes ( "p #e ( sub*apt] ,c ( *apt] ,,vii ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;j-#ba et seq471 9 ! lett]s f ! ,secret>y ( ,heal? & ,human ,s]vices to ! ,*airman ( ! ,committee on ,en]gy & ,comm]ce ( ! ,h\se ( ,repres5tatives & ! ,*airman ( ! ,committee on ,heal?1 ,education1 ,labor & ,p5sions ( ! ,s5ate z set =? 9 ! ,congressional ,record4 #bjb4 ,au?ority to assess & use g5]ic new animal drug fees 7a7 ,g5]ic ,inve/igational ,new ,animal ,drug ,file ,fee ,section #gda7;a7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;j-#ba7;a77 is am5d$ by add+ at ! end ! foll[+3 7#d7 ,g5]ic inve/igational new animal drug file fee 7,a7 ,9 g5]al 7i7 ,new file reque/ ,ea* p]son t submits a reque/ to e/abli% a g5]ic inve/igational new animal drug file on or aft] ,octob] #a1 #bjbc1 %all be assess$ a fee z e/abli%$ "u subsection 7c74 7ii7 ,new submission to e/abli%$ file ,ea* p]son t makes a submission to a g5]ic inve/igational new animal drug file on or aft] ,octob] #a1 #bjbc1 :]e su* file 0 e/abli%$ prior to ,octob] #a1 #bjbc1 %all be assess$ a fee = ! fir/ submission on or aft] ,octob] #a1 #bjbc1 z e/abli%$ "u subsection 7c74 7,b7 ,paym5t 7i7 ,new file reque/ ,! fee requir$ by subp>agraph 7,a77i7 %all be due ^u submission ( ! reque/ to e/abli% ! g5]ic inve/igational new animal drug file4 7ii7 ,new submission to e/abli%$ file ,! fee requir$ by subp>agraph 7,a77ii7 %all be due ^u ! fir/ submission to ! g5]ic inve/igational new animal drug file4 7,c7 ,exceptions 7i7 ,t]m9at+ an exi/+ g5]ic inve/igational new animal drug file ,if a p]son makes a submission to ! g5]ic inve/igational new animal drug file to t]m9ate t file1 ! p]son %all n be subject to a fee "u subp>agraph 7,a77ii7 = t submission4 7ii7 ,transf]r+ an exi/+ g5]ic inve/igational new animal drug file ,if a p]son makes a submission to ! g5]ic inve/igational new animal drug file to transf] t file to a diff]5t g5]ic new animal drug sponsor1 ! p]son %all n be subject to a fee "u subp>agraph 7,a77ii7 = t submission4 4 7b7 ,fee rev5ue am\nts ,section #gda7;b7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;j-#ba7;b77 is am5d$-- 7#a7 9 p>agraph 7#a7-- 7,a7 by /rik+ #bjai ?r\gh #bjbc & ins]t+ #bjbd ?r\gh #bjbh2 & 7,b7 by /rik+ #ah1ccf1cdj & ins]t+ #be1jjj1jjj2 & 7#b7 9 p>agraph 7#b7-- 7,a7 9 subp>agraph 7,a7-- 7i7 by /rik+ #be p]c5t & ins]t+ #bj p]c5t2 & 7ii7 by ins]t+ be=e ! semicolon at ! end ! foll[+3 & fees "u subsection 7a77#d7 7relat+ to g5]ic inve/igational new animal drug files72 7,b7 9 subp>agraph 7,b71 by /rik+ #cg4e p]c5t & ins]t+ #dj p]c5t2 & 7,c7 9 subp>agraph 7,c71 by /rik+ #cg4e p]c5t & ins]t+ #dj p]c5t4 7c7 ,annual fee sett+2 adju/m5ts 7#a7 ,annual fee sett+ ,section #gda7;c77#a7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;j-#ba7;c77#a77 is am5d$ to read z foll[s3 7#a7 ,annual fee sett+ ,! ,secret>y %all e/abli%1 n lat] ?an #fj days be=e ! />t ( ea* fiscal ye> beg9n+ aft] ,septemb] #cj1 #bjbc1 = t fiscal ye>-- 7,a7 abbreviat$ application fees t are bas$ on ! rev5ue am\nts e/abli%$ "u subsection 7b71 ! adju/m5ts provid$ "u ?is subsection1 & ! am\nt ( fees anticipat$ to be collect$ "u subsection 7a77#d7 dur+ t fiscal ye>2 7,b7 g5]ic new animal drug sponsor fees1 & g5]ic new animal drug product fees1 bas$ on ! rev5ue am\nts e/abli%$ "u subsection 7b7 & ! adju/m5ts provid$ "u ?is subsection2 & 7,c7 a g5]ic inve/igational new animal drug file fee ( #ej1jjj = ea* reque/ or submission describ$ 9 subsection 7a77#d77;,a74 4 7#b7 ,inflation adju/m5t ,section #gda7;c77#b7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;j-#ba7;c77#b77 is am5d$-- 7,a7 9 subp>agraph 7,a7-- 7i7 9 ! matt] prec$+ clause 7i71 by /rik+ #bjbj & ins]t+ #bjbe2 & 7ii7 9 clause 7iii71 by /rik+ ,baltimore & ins]t+ ,arl+ton-,alex&ria2 & 7,b7 9 subp>agraph 7,b71 by /rik+ #bjbj & ins]t+ #bjbe4 7#c7 ,workload adju/m5t ,section #gda7;c77#c7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;j-#ba7;c77#c77 is am5d$-- 7,a7 9 subp>agraph 7,a7-- 7i7 9 ! matt] prec$+ clause 7i71 by /rik+ #bjbj & ins]t+ #bjbe2 7ii7 9 clause 7i7-- 7,i7 by /rik+ & inve/igational g5]ic new animal drug protocol submissions & ins]t+ inve/igational g5]ic new animal drug protocol submissions1 reque/s to e/abli% a g5]ic inve/igational new animal drug file1 & g5]ic inve/igational new animal drug meet+ reque/s2 & 7,,ii7 by /rik+ 2 & & ins]t+ a semicolon2 7iii7 by r$esignat+ clause 7ii7 z clause 7iii72 & 7iv7 by ins]t+ aft] clause 7i7 ! foll[+3 7ii7 if ! workload adju/m5t calculat$ by ! ,secret>y "u clause 7i7 exce$s #be p]c5t1 ! ,secret>y %all use #be p]c5t = ! adju/m5t2 & 2 & 7,b7 9 subp>agraph 7,b71 by /rik+ #bjba ?r\gh #bjbc & ins]t+ #bjbf ?r\gh #bjbh4 7#d7 ,f9al ye> adju/m5t ,section #gda7;c77#d7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;j-#ba7;c77#d77 is am5d$-- 7,a7 by /rik+ #bjbc ea* place x appe>s & ins]t+ #bjbh2 & 7,b7 by /rik+ #bjbd & ins]t+ #bjbi4 7d7 ,fee waiv] or r$uction2 exemption f fees ,subsection 7d7 ( section #gda ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;j-#ba7 is am5d$ to read z foll[s3 7d7 ,fee waiv] or r$uction ,! ,secret>y %all grant a waiv] f1 or a r$uction (1 "o or m fees assess$ "u subsection 7a7 :]e ! ,secret>y f9ds t ! g5]ic new animal drug is int5d$ solely to provide = a m9or use or m9or species indication4 4 7e7 ,effect ( failure ,to pay fees ,section #gda7;e7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;j-#ba7;e77 is am5d$ by /rik+ ,! ,secret>y may discont9ue & ins]t+ ,a reque/ to e/abli% a g5]ic inve/igational new animal drug file t is submitt$ by a p]son subject to fees "u subsection 7a7 %all be consid]$ incomplete & %all n be accept$ = action by ! ,secret>y until all fees ow$ by su* p]son h be5 paid4 ,! ,secret>y may discont9ue4 7f7 ,assessm5t ( fees ,section #gda7;f77#b7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;j-#ba7;f77#b77 is am5d$ by /rik+ sponsors1 & g5]ic new animal drug products at any "t & ins]t+ products1 g5]ic new animal drug sponsors1 & g5]ic inve/igational new animal drug files at any "t4 7g7 ,cr$it+ & availability ( fees ,section #gda7;g7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;j-#ba7;g77 is am5d$-- 7#a7 9 p>agraph 7#c71 by /rik+ #bjai ?r\gh #bjbc & ins]t+ #bjbd ?r\gh #bjbh2 7#b7 by /rik+ ! second p>agraph 7#d7 7relat+ to ,(fset71 z add$ by section #bjb ( ! ,animal ,g5]ic ,drug ,us] ,fee ,am5dm5ts ( #bjac 7,public ,law #aac-ad72 & 7#c7 by add+ at ! end ! foll[+3 7#e7 ,recov]y ( collection %ortfalls ,! am\nt ( fees o!rwise au?oriz$ to be collect$ "u ?is section %all be increas$-- 7,a7 = fiscal ye> #bjbf1 by ! am\nt1 if any1 by :i* ! am\nt collect$ "u ?is section & appropriat$ = fiscal ye> #bjbd falls bel[ ! am\nt ( fees au?oriz$ = fiscal ye> #bjbd "u p>agraph 7#c72 7,b7 = fiscal ye> #bjbg1 by ! am\nt1 if any1 by :i* ! am\nt collect$ "u ?is section & appropriat$ = fiscal ye> #bjbe falls bel[ ! am\nt ( fees au?oriz$ = fiscal ye> #bjbe "u p>agraph 7#c72 & 7,c7 = fiscal ye> #bjbh1 by ! am\nt1 if any1 by :i* ! am\nt collect$ "u ?is section & appropriat$ = fiscal ye>s #bjbf & #bjbg 7includ+ e/imat$ collections = fiscal ye> #bjbg7 falls bel[ ! am\nt ( fees au?oriz$ = su* fiscal ye>s "u p>agraph 7#c74 4 7h7 ,def9itions ,section #gda7k7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;j-#ba7k77 is am5d$-- 7#a7 by r$esignat+ p>agraphs 7#h71 7#i71 7#aj71 & 7#aa7 z p>agraphs 7#i71 7#aj71 7#aa71 & 7#ac71 respectively2 7#b7 by ins]t+ aft] p>agraph 7#g7 ! foll[+3 7#h7 ,g5]ic inve/igational new animal drug meet+ reque/ ,! t]m g5]ic inve/igational new animal drug meet+ reque/ means a reque/ submitt$ by a g5]ic new animal drug sponsor to meet ) ! ,secret>y to discuss an inve/igational submission = a g5]ic new animal drug4 2 7#c7 9 p>agraph 7#aa7 7z s r$esignat$71 by add+ at ! end ! foll[+3 7,i7 ,! activities necess>y = exploration & implem5tation ( ! ,unit$ ,/ates & ,european ,union ,mutual ,recognition ,agreem5t = ,ph>maceutical ,good ,manufactur+ ,practice ,inspections1 & ! ,unit$ ,/ates & ,unit$ ,k+dom ,mutual ,recognition ,agreem5t ,sectoral ,annex = ,ph>maceutical ,good ,manufactur+ ,practices1 & o!r mutual recognition agreem5ts1 ) respect to g5]ic new animal drug products subject to review1 includ+ implem5tation activities prior to & foll[+ product approval4 2 & 7#d7 by ins]t+ aft] p>agraph 7#aa7 7z s r$esignat$7 ! foll[+3 7#ab7 ,reque/ to e/abli% a g5]ic inve/igational new animal drug file ,! t]m reque/ to e/abli% a g5]ic inve/igational new animal drug file means ! submission to ! ,secret>y ( a reque/ to e/abli% a g5]ic inve/igational new animal drug file to conta9 inve/igational submissions = a g5]ic new animal drug4 4 #bjc4 ,reau?orization2 report+ requirem5ts ,section #gdb ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;j-#bb7 is am5d$-- 7#a7 9 subsection 7a71 by /rik+ #bjah & ins]t+ #bjbc2 7#b7 by /rik+ #bjai ea* place x appe>s 9 subsections 7a7 & 7b7 & ins]t+ #bjbd2 & 7#c7 9 subsection 7d71 by /rik+ #bjbc ea* place x appe>s & ins]t+ #bjbh4 #bjd4 ,sav+s clause ,not)/&+ ! am5dm5ts made by ?is title1 "p #e ( sub*apt] ,c ( *apt] ,,vii ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;j-#ba et seq471 z 9 effect on ! day be=e ! date ( enactm5t ( ?is title1 %all cont9ue to be 9 effect ) respect to abbreviat$ applications = a g5]ic new animal drug & supplem5tal abbreviat$ applications = a g5]ic new animal drug 7z def9$ 9 su* "p z ( su* day7 t on or aft] ,octob] #a1 #bjah1 b be=e ,octob] #a1 #bjbc1 7 accept$ by ! ,food & ,drug ,adm9i/ration = fil+ ) respect to assess+ & collect+ any fee requir$ by su* "p = a fiscal ye> prior to fiscal ye> #bjbd4 #bje4 ,effective date ,! am5dm5ts made by ?is title %all take effect on ,octob] #a1 #bjbc1 or ! date ( ! enactm5t ( ?is ,act1 :i*ev] is lat]1 except t fees "u "p #e ( sub*apt] ,c ( *apt] ,,vii ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;j-#ba et seq471 z am5d$ by ?is title1 %all be assess$ = abbreviat$ applications = a g5]ic new animal drug & supplem5tal abbreviat$ applications = a g5]ic new animal drug receiv$ on or aft] ,octob] #a1 #bjbc1 reg>dless ( ! date ( enactm5t ( ?is ,act4 #bjf4 ,sunset dates 7a7 ,au?orization ,section #gda ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;j-#ba7 %all cease to be effective ,octob] #a1 #bjbh4 7b7 ,report+ requirem5ts ,section #gdb ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;j-#bb7 %all cease to be effective ,janu>y #ca1 #bjbi4 7c7 ,previ\s sunset provision ,effective ,octob] #a1 #bjbc1 subsections 7a7 & 7b7 ( section #bjf ( ! ,animal ,g5]ic ,drug ,us] ,fee ,am5dm5ts ( #bjah 7,public ,law #aae-bcd7 are repeal$4 ,,iii ,support+ ,animal & ,human ,heal? #cja4 ,report+ requirem5ts ,section #gdj;,a ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;j-#ac71 z am5d$ by section #ajd1 is fur!r am5d$-- 7#a7 9 subsection 7a7-- 7,a7 by /rik+ ,beg9n+ ) & ins]t+ ! foll[+3 7#a7 ,9 g5]al ,beg9n+ ) 2 & 7,b7 by add+ at ! end ! foll[+3 7#b7 ,cont5ts ,! report "u p>agraph 7#a7 %all include ! foll[+3 7,a7 ,data1 analysis & discussion ( ! *anges 9 ! numb] ( individuals hir$ & fund$ by fees collect$ pursuant to section #gdj1 & data1 analysis1 & discussion ( ! numb] ( full-"t equival5ts 9 ! animal drug review program1 includ+ a breakd[n by fund+ f fees collect$ pursuant to section #gdj v]sus budget au?ority1 & by ea* (fice )9 ! ,c5t] = ,vet]9>y ,m$ic9e1 ! ,(fice ( ,regulatory ,affairs1 & ! ,(fice ( ! ,commission]4 7,b7 ,data1 analysis1 & discussion ( ! *anges 9 ! fee rev5ue am\nts & co/s = ! process = ! review ( animal drug applications1 includ+ id5tify+-- 7i7 ! driv]s ( su* *anges2 & 7ii7 *anges 9 ! total co/ p] full-"t equival5t 9 ! animal drug review program4 7,c7 ,data1 analysis1 & discussion ( *anges 9 ! av]age full-"t equival5t h\rs requir$ to complete review ( ea* type ( animal drug application4 7,d7 ,= fiscal ye>s #bjbd & #bjbe1 ( ! meet+ reque/s f animal drug sponsors = :i* ! ,secret>y has det]m9$ t a face-to-face meet+ is appropriate1 ! numb] ( face-to-face meet+s reque/$ by sponsors to be conduct$ 9 p]son 79 su* mann] z ! ,secret>y %all prescribe on ! website ( ! ,food & ,drug ,adm9i/ration71 & ! numb] ( su* 9-p]son meet+s grant$ by ! ,secret>y4 2 & 7#b7 9 subsection 7d7-- 7,a7 9 p>agraph 7#e71 by ins]t+ a comma aft] p>agraph 7#d72 7,b7 by r$esignat+ p>agraph 7#f7 z p>agraph 7#g72 7,c7 by ins]t+ aft] p>agraph 7#e7 ! foll[+3 7#f7 ,updates to ,congress ,! ,secret>y1 9 consultation ) regulat$ indu/ry1 %all provide regul> updates on negotiations on ! reau?orization ( ?is "p to ! ,committee on ,heal?1 ,education1 ,labor1 & ,p5sions ( ! ,s5ate & ! ,committee on ,en]gy & ,comm]ce ( ! ,h\se ( ,repres5tatives4 2 & 7,d7 9 p>agraph 7#g7 7z s r$esignat$7-- 7i7 9 subp>agraph 7,a7-- 7,i7 by /rik+ ,be=e pres5t+ ! recomm5dations develop$ "u p>agraphs 7#a7 ?r\gh 7#e7 to ,congress1 ! ,secret>y & ins]t+ ,! ,secret>y2 & 7,,ii7 by ins]t+ be=e ! p]iod at ! end ! foll[+3 1 n lat] ?an #cj days aft] ea* su* negotiation meet+2 & 7ii7 9 subp>agraph 7,b71 by ins]t+ 1 9 suffici5t detail1 aft] %all summ>ize4 #cjb4 ,def9ition ( major species ,section #bja7nn7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cba7nn77 is am5d$ by ins]t+ 1 or remove species f1 aft] add species to4 #cjc4 ,antimicrobial resi/ance 7a7 ,report on ,antimicrobial ,/ew>d%ip ,n lat] ?an ,decemb] #ca1 #bjbc1 ! ,secret>y ( ,heal? & ,human ,s]vices1 act+ ?r\gh ! ,commission] ( ,food & ,drugs1 %all submit to ! ,committee on ,en]gy & ,comm]ce ( ! ,h\se ( ,repres5tatives & ! ,committee on ,heal?1 ,education1 ,labor1 & ,p5sions ( ! ,s5ate a report describ+-- 7#a7 activities conduct$ by ! ,c5t] = ,vet]9>y ,m$ic9e ( ! ,food & ,drug ,adm9i/ration 7ref]r$ to 9 ?is section z ! ,c5t]7 dur+ ! p]iod ( fiscal ye>s #bjai ?r\gh #bjbc to support antimicrobial /ew>d%ip 9 vet]9>y sett+s1 includ+ ongo+ activities & ! t>get$ completion date ( su* activities2 & 7#b7 ) respect to antimicrobial /ew>d%ip 9 vet]9>y sett+s-- 7,a7 ! goals ( ! ,c5t] reg>d+ support+ antimicrobial /ew>d%ip 9 vet]9>y sett+s2 7,b7 activities ! ,c5t] plans to execute dur+ ! p]iod ( fiscal ye>s #bjbd ?r\gh #bjbh to support su* goals1 includ+ t>get$ completion dates = su* activities2 & 7,c7 metrics ! ,c5t] plans to use to evaluate progress t[>d its goals reg>d+ support+ antimicrobial /ew>d%ip 9 vet]9>y sett+s4 7b7 ,annual progress reports ,n lat] ?an #abj days aft] ! end ( ea* fiscal ye> dur+ :i* fees are collect$ "u section #gdj1 ! ,secret>y %all submit to ! ,committee on ,en]gy & ,comm]ce ( ! ,h\se ( ,repres5tatives & ! ,committee on ,heal?1 ,education1 ,labor1 & ,p5sions ( ! ,s5ate a report t includes-- 7#a7 a description ( activities conduct$ by ! ,c5t] 9 ! prior fiscal ye> to support antimicrobial /ew>d%ip 9 vet]9>y sett+s1 includ+ progress made t[>d goals & activities specifi$ 9 subsection 7a77#b72 7#b7 9 ! case ( an incomplete activity describ$ 9 subsection 7a77#b77;,b7 = :i* ! t>get completion date has pass$-- 7,a7 an explanation = :y su* t>get completion date 0 n met2 & 7,b7 if applicable1 ! updat$ expect$ completion date = su* activity2 7#c7 a description ( em]g+ *all5ges relat$ to antimicrobial /ew>d%ip 9 vet]9>y sett+s t impact ,c5t] activities2 & 7#d7 a description ( activities und]tak5 to inc5tivize ! developm5t ( new drugs = ! treatm5t1 prev5tion1 or control ( bact]ial diseases 9 animals4