,,ii #aaf? ,,congress #a/ ,session ,s4 #gbf ,,9 ,,! ,,s5ate ,,( ,,! ,,unit$ ,,/ates ,m>* #g1 #bjai,mrs4 ,fe9/e9 7= h]self & ,ms4 ,coll9s7 introduc$ ! foll[+ bill2 :i* 0 read twice & ref]r$ to ! ,committee on ,heal?1 ,education1 ,labor1 & ,p5sions ,a ,,bill ,to am5d ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act to ensure ! safety ( cosmetics4 #a4 ,%ort title2 table ( cont5ts 7a7 ,%ort title ,?is ,act may be cit$ z ! ,p]sonal ,c>e ,products ,safety ,act4 7b7 ,table ( cont5ts ,! table ( cont5ts = ?is ,act is z foll[s3 ,sec4 #a4 ,%ort title2 table ( cont5ts4 ,title ,i--,cosmetic ,safety ,sec4 #aja4 ,regi/ration ( cosmetics facilities & cosmetic +r$i5t /atem5ts4 ,sec4 #ajb4 ,review ( +r$i5ts & non-functional con/itu5ts4 ,sec4 #ajc4 ,good manufactur+ practices = cosmetics4 ,sec4 #ajd4 ,adv]se ev5t reports4 ,sec4 #aje4 ,records inspection2 m&atory recall au?ority4 ,sec4 #ajf4 ,label+4 ,sec4 #ajg4 ,coal t> *emicals4 ,sec4 #ajh4 ,s5se ( ! ,s5ate on animal te/+4 ,sec4 #aji4 ,preemption4 ,sec4 #aaj4 ,report+4 ,sec4 #aaa4 ,small bus9esses4 ,sec4 #aab4 ,applicability ) respect to c]ta9 cosmetics4 ,sec4 #aac4 ,en=cem5t4 ,sec4 #aad4 ,consum] in=mation4 ,title ,,ii--,fees ,relat$ to ,cosmetic ,safety ,sec4 #bja4 ,f9d+s4 ,sec4 #bjb4 ,au?ority to assess & use cosmetic safety fees4 ,sec4 #bjc4 ,direct hir+ au?ority to support activities relat$ to cosmetics4 ,i ,cosmetic ,safety #aja4 ,regi/ration ( cosmetics facilities & cosmetic +r$i5t /atem5ts 7a7 ,am5dm5ts ,*apt] ,,vi ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cfa et seq47 is am5d$ by add+ at ! end ! foll[+3 #fjd4 ,def9itions ,9 ?is *apt]3 7#a7 ,cosmetic =mulation ,! t]m cosmetic =mulation means a prep>ation ( cosmetic raw mat]ials ) a qualitatively & quantitatively set composition4 7#b7 ,cosmetic product ,! t]m cosmetic product means a prep>ation ( cosmetic raw +r$i5ts1 :i* may come 9 a range ( possible am\nts = ea* +r$i5t1 = purposes ( introduction into int]/ate comm]ce z a f9i%$ product4 7#c7 ,facility ,! t]m facility includes any factory1 w>eh\se1 or e/abli%m5t 7includ+ a factory1 w>eh\se1 or e/abli%m5t ( an import]7 t manufactures or processes cosmetic products or cosmetic =mulations1 or any o!r entity ^: "n & address appe> on ! label ( a cosmetic product4 ,su* t]m does n include-- 7,a7 beauty %ops & salons t d n o!rwise manufacture1 process1 or package cosmetics at t location2 7,b7 cosmetic product retail]s1 includ+ individual sales repres5tatives1 direct sell]s1 retail di/ribution facilities1 & ph>macies1 t d n o!rwise manufacture1 process1 or package cosmetics at t location2 7,c7 hospitals1 physicians' (fices1 & heal? c>e cl9ics2 7,d7 public heal? ag5cies & o!r nonpr(it entities t provide cosmetics directly to ! consum]2 7,e7 hotels & o!r entities t provide complim5t>y cosmetics to gue/s2 7,f7 trade %[s & o!r v5ues :]e cosmetic product samples are provid$ free ( *>ge2 7,g7 a factory1 w>eh\se1 or e/abli%m5t (-- 7i7 dome/ic manufactur]s ) less ?an #ejj1jjj 9 av]age gross annual sales ( cosmetic products 9 ! ,unit$ ,/ates = ! previ\s #c-ye> p]iod1 or less ?an #a1jjj1jjj 9 su* sales ( cosmetic products produc$ 9 a private resid5ce2 or 7ii7 entities t manufacture or comp\nd cosmetic products solely = use 9 rese>*1 tea*+1 or pilot plant production & n = sale2 or 7,h7 an e/abli%m5t t solely p]=ms "o or m ( ! foll[+ ) respect to cosmetic products3 label+1 relabel+1 packag+1 repackag+1 hold+1 or di/ribut+4 7#d7 ,=eign facility ,! t]m =eign facility means a facility t manufactures or processes a cosmetic =mulation or cosmetic product t is export$ to ! ,unit$ ,/ates )\t fur!r process+ or packag+ inside ! ,unit$ ,/ates4 ,a cosmetic is n consid]$ to h und]gone fur!r process+ or packag+ = purposes ( ?is def9ition solely on ! basis t label+ 0 add$ or t any simil> activity ( a de m9imis nature 0 c>ri$ out ) respect to ! cosmetic4 7#e7 ,non-functional con/itu5t ,! t]m non-functional con/itu5t means any sub/ance t is an incid5tal compon5t ( an +r$i5t1 a breakd[n product ( an +r$i5t or a byproduct ( ! manufactur+ process t has n be5 int5tionally add$ z a sep>ate sub/ance & s]ves no te*nical function 9 ! cosmetic4 7#f7 ,responsible p]son ,! t]m responsible p]son means-- 7,a7 ! br& own] :o is ! dome/ic or =eign manufactur] or entity ^: "n appe>s on a cosmetic product label ( a cosmetic product di/ribut$ 9 ! ,unit$ ,/ates1 except = entities describ$ 9 subp>agraphs 7,a7 ?r\gh 7,h7 ( p>agraph 7#c72 or 7,b7 a contract manufactur] :o provides cosmetic products to ! entities describ$ 9 subp>agraphs 7,a7 ?r\gh 7,h7 ( p>agraph 7#c74 4 #fje4 ,regi/ration ( cosmetic facilities 7a7 ,regi/ration & fees = exi/+ manufactur+ or process+ ( cosmetics 7#a7 ,regi/ration1 9 g5]al ,n lat] ?an ,decemb] #a1 #bjai1 & at a simil> "t 9 ea* subsequ5t ye>1 z det]m9$ by ! ,food & ,drug ,adm9i/ration1 ea* responsible p]son engag$ 9 manufactur+ or process+ a cosmetic product or a cosmetic =mulation di/ribut$ 9 ! ,unit$ ,/ates %all regi/] all ( ! responsible p]son's facilities ) ! ,food & ,drug ,adm9i/ration4 7#b7 ,fees ,if ! av]age gross annual sales 9 ! ,unit$ ,/ates ( cosmetic products ( all ( ! responsible p]son's facilities regi/]$ "u p>agraph 7#a7 = ! previ\s #c-ye> p]iod is great] ?an #aj1jjj1jjj1 a regi/ration %all n be complete "u ?is subsection until ! responsible p]son has paid any regi/ration fee requir$ "u section #gdd,l4 7b7 ,regi/ration by new facilities ,any facility fir/ engag+ aft] ! date ( enactm5t ( ! ,p]sonal ,c>e ,products ,safety ,act 9 an activity t w\ld require x to regi/] "u subsection 7a7 %all regi/] ) ! ,food & ,drug ,adm9i/ration )9 #fj days ( fir/ engag+ 9 su* activity1 & !reaft] 9 accordance ) subsection 7a74 7c7 ,contract manufactur]s ,if a facility manufactures or processes cosmetic products on behalf ( a responsible p]son1 ! ,food & ,drug ,adm9i/ration %all require only a s+le regi/ration = su* facility ev5 if su* facility is manufactur+ or process+ its own cosmetic products or cosmetic products on behalf ( m ?an #a responsible p]son4 ,su* s+le regi/ration may be submitt$ to ! ,food & ,drug ,adm9i/ration by su* facility or any responsible p]son ^: products are manufactur$ or process$ at su* facility4 7d7 ,*anges to in=mation ,a regi/rant :o has submitt$ a regi/ration "u ?is section %all notify ! ,food & ,drug ,adm9i/ration ( any *ange to ! in=mation requir$ "u subsection 7a7 or 7b7 n lat] ?an #fj days aft] ! date ( su* *ange1 unless o!rwise specifi$ by ! ,food & ,drug ,adm9i/ration4 7e7 ,=mat2 cont5ts 7#a7 ,electronic =mat ,ea* regi/ration %all be submitt$ us+ an electronic =mat1 z specifi$ 9 a regi/ration =m provid$ by ! ,food & ,drug ,adm9i/ration4 7#b7 ,cont5ts 7,a7 ,9 g5]al ,except z provid$ 9 subp>agraph 7,b71 ! regi/ration %all conta9 ! foll[+ in=mation3 7i7 ,ea* facility's "n & full address1 id5tify+ ! precise physical location ( ! facility4 7ii7 ,! id5tity ( ! facility1 includ+ ! unique facility id5tifi]1 if any1 previ\sly assign$ by ! ,food & ,drug ,adm9i/ration to ! facility "u subsection 7h74 7iii7 ,all bus9ess trad+ names us$ by ! facility4 7iv7 ,! product category or categories ( ea* cosmetic product or cosmetic =mulation manufactur$ or process$ at ! facility or on ^: label ! facility's "n & address appe>4 7v7 ,! type ( activity conduct$ at ! facility 7su* z manufactur+ or process+74 7vi7 ,! "n1 title1 /reet address1 telephone numb]1 & electronic contact in=mation ( ! em]g5cy contact = ! facility4 7vii7 ,9 ! case ( a =eign facility1 ! "n1 /reet address1 telephone numb]1 em]g5cy contact in=mation1 & "n ( ! ,unit$ ,/ates ag5t = ! facility1 &1 if available1 ! electronic contact in=mation ( ! ,unit$ ,/ates ag5t4 7viii7 ,! "n1 title1 /reet address1 telephone numb]1 & electronic contact in=mation ( ! individual submitt+ ! regi/ration4 7ix7 ,an assurance t ! ,food & ,drug ,adm9i/ration w be p]mitt$ to inspect su* facility at ! times & 9 ! mann] p]mitt$ by ?is ,act4 7x7 ,additional in=mation p]ta9+ to ! facility or to ! cosmetic products or cosmetic =mulations manufactur$ or process$ at ! facility1 or on ^: label ! facility's "n & address appe>1 includ+ all br& names kn[n to consum]s1 z ! ,food & ,drug ,adm9i/ration may require by regulation4 7xi7 ,an +r$i5t li/+ = all cosmetic products manufactur$ or process$ 9 su* facility1 9 accordance ) subsection 7f71 :i*1 = ea* relevant cosmetic product1 may be submitt$ to ! ,food & ,drug ,adm9i/ration z "p ( su* regi/ration or sep>ately4 7xii7 ,a writt5 assurance t ea* cosmetic product manufactur$ or process$ 9 su* facility has be5 sub/antiat$ = safety or c>ries ! w>n+ requir$ "u section #gdj4aj ( title #ba1 ,code ( ,f$]al ,regulations 7or any successor regulations74 ,! responsible p]son %all ma9ta9 records docum5t+ any su* sub/antiation ( safety & ! in=mation on :i* su* det]m9ation is bas$ until #e ye>s aft] ! f9i%$ product is no long] m>ket$1 except t a responsible p]son = a dome/ic company ^: sales are "u #b1jjj1jjj p] ye> %all ma9ta9 su* records = at lea/ #b ye>s aft] ! f9i%$ product is no long] m>ket$4 7,b7 ,small bus9esses 7i7 ,requirem5ts ,9 ! case ( a regi/rant describ$ 9 clause 7ii71 ! regi/ration %all conta9 ! foll[+ in=mation3 7,i7 ,ea* facility's "n & full address1 id5tify+ ! precise physical location ( ! facility4 7,,ii7 ,! "n1 title1 /reet address1 telephone numb]1 & electronic contact in=mation ( ! em]g5cy contact = ! facility4 7,,iii7 ,! consum] product category or categories ( ea* cosmetic product or cosmetic =mulation manufactur$1 process$1 pack$1 or held at ! facility or on ^: label ! facility's "n & address appe>4 7ii7 ,small bus9ess regi/rants ,a regi/rant describ$ 9 ?is clause is a dome/ic regi/rant-- 7,i7 ^: av]age gross annual sales 9 ! ,unit$ ,/ates ( cosmetic products = ! previ\s #c-ye> p]iod is betwe5 #ejj1jjj & #b1jjj1jjj 7or betwe5 #a1jjj1jjj & #b1jjj1jjj 9 ! case ( sales ( cosmetic products produc$ 9 a private resid5ce72 & 7,,ii7 :o does n produce-- 7aa7 products t are int5d$ to g on ! eye area2 7bb7 lip products ) color2 7cc7 products t are inject$2 7dd7 products t are int5d$ = int]nal use2 or 7ee7 products t are meant to alt] appe>ance = m ?an #bd h\rs4 7iii7 ,guidance ,! ,food & ,drug ,adm9i/ration %all1 aft] consultation ) ! ,small ,bus9ess ,adm9i/ration & small bus9esses t manufacture cosmetics1 provide additional guidance = small bus9esses on compliance ) ! requirem5ts ( ?is section t w\ld apply to small bus9ess regi/rants4 ,su* guidance %all include specific examples ( options = compliance t d n place an undue burd5 on small bus9esses4 7#c7 ,abbreviat$ regi/ration ,! ,food & ,drug ,adm9i/ration %all provide = an abbreviat$ regi/ration r5ewal process = any regi/rant t has n _h any *anges to ! requir$ in=mation ) respect to ! facility or facilities involv$ s9ce ! regi/rant submitt$ ! prec$+ regi/ration4 7f7 ,cosmetic product +r$i5t li/+ 7#a7 ,9 g5]al ,! +r$i5t li/+ requir$ pursuant to subsection 7e77#b77;,a77xi7 %all include-- 7,a7 ! unique id5tifi] assign$ "u section 7h71 z applicable1 (-- 7i7 ea* facility :]e ! cosmetic product is manufactur$ or process$2 & 7ii7 ! facility ^: "n & address appe> on ! label1 unless ! /atem5t is fil$ by a contract manufactur] describ$ 9 section #fjd7f77;,b72 7,b7 ! br& "n & ! full "n = ! cosmetic product z x appe>s on ! label2 7,c7 ! cosmetic product li/+ numb]1 if any1 previ\sly assign$ to ! cosmetic product by ! ,food & ,drug ,adm9i/ration "u p>agraph 7#d72 7,d7 ! applicable cosmetic category = ! cosmetic product2 7,e7 a li/ ( +r$i5ts 9 ! cosmetic product1 includ+ a range ( possible am\nts ( ea* +r$i5t1 id5tifi$ by ! "n adopt$ 9 regulations promulgat$ by ! ,food & ,drug ,adm9i/ration1 if any1 or by ! common or usual "n ( ! +r$i5t1 :i* %all include-- 7i7 a li/ ( fragrances1 flavors1 & colors t may be includ$ 9 ! product1 int]*angeably1 ) ranges ( possible am\nts1 :i* %all include-- 7,i7 9 ! case ( fragrances t are pur*as$ f a fragrance suppli]1 id5tification ( ! fragrances by ! "n or code provid$ by ! suppli]1 includ+ ! "n & contact in=mation = ! fragrance suppli]2 & 7,,ii7 9 ! case ( flavors t are pur*as$ f a flavor suppli]1 id5tification ( ! flavors by ! "n or code provid$ by ! suppli]1 includ+ ! "n & contact in=mation = ! flavor suppli]2 & 7ii7 o!r appropriate int]*angeable +r$i5ts z ! ,food & ,drug ,adm9i/ration may specify 9 regulations or guidance t may be includ$ 9 ! product1 ) ranges ( possible am\nts2 7,f7 ! title & full contact in=mation ( ea* individual submitt+ ! /atem5t2 7,g7 if applicable1 in=mation on ! label+ requir$ "u section #fab2 & 7,h7 if applicable1 in=mation %[+ t ! cosmetic +r$i5t or +r$i5ts 9 ! product meet any specifi$ conditions ( use or tol]ances requir$ foll[+ a f9al det]m9ation ( safety "u section #fjg7;d74 7#b7 ,additional in=mation ,9 ! case ( a cosmetic +r$i5t /atem5t t includes a li/ ( fragrances or flavors t are pur*as$ f a fragrance or flavor suppli] z describ$ 9 p>agraph 7#a77;,e77i71 ^u reque/ by ! ,food & ,drug ,adm9i/ration1 ! fragrance or flavor suppli] %all submit to ! ,food & ,drug ,adm9i/ration ! complete li/ ( +r$i5ts 9 specific fragrances or flavors1 n lat] ?an #cj days aft] receiv+ su* reque/4 7#c7 ,cosmetic product +r$i5t /atem5t = new or re=mulat$ cosmetic products 7,a7 ,9 g5]al ,except z provid$ "u subp>agraph 7,b71 9 ! case ( a cosmetic product t is fir/ m>ket$ aft] ! date ( enactm5t ( ! ,p]sonal ,c>e ,products ,safety ,act or a cosmetic product t is re=mulat$ aft] su* date ( enactm5t1 ! responsible p]son %all submit a cosmetic +r$i5t /atem5t to ! ,food & ,drug ,adm9i/ration )9 #fj days ( fir/ m>ket+ ! new cosmetic product or re=mulat$ cosmetic product1 & annually !reaft]4 7,b7 ,small bus9esses ,! ,food & ,drug ,adm9i/ration %all all[ a responsible p]son t is a bus9ess t meets ! applicable indu/ry-bas$ small bus9ess size /&>d e/abli%$ by ! ,adm9i/rator ( ! ,small ,bus9ess ,adm9i/ration "u section #c ( ! ,small ,bus9ess ,act to h a p]iod long] ?an #fj days to submit an initial new cosmetic +r$i5t /atem5t "u subp>agraph 7,a74 7,c7 ,def9ition ,a cosmetic product %all n be consid]$ fir/ m>ket$ or re=mulat$ aft] ! date ( enactm5t "u subp>agraph 7,a7 if ! only *ange 9 su* product is 9-- 7i7 ! am\nt ( an exi/+ +r$i5t if x is )9 ! range previ\sly report$ "u p>agraph 7#a77;,e72 or 7ii7 ! addition or subtraction ( a fragrance1 flavor1 or color1 or su* o!r int]*angeable +r$i5ts specifi$ by ! ,food & ,drug ,adm9i/ration 9 regulations or guidance1 previ\sly report$ z a pot5tial +r$i5t "u p>agraph 7#a77;,e71 if1 9 ! case ( su* an addition1 ! am\nt is )9 ! range previ\sly report$4 7#d7 ,cosmetic products li/ ,at ! "t ( ! initial submission ( any cosmetic +r$i5t /atem5t "u ?is section1 ! ,food & ,drug ,adm9i/ration %all assign a unique cosmetic product li/+ numb] to ! cosmetic +r$i5t /atem5t4 ,bas$ on su* cosmetic +r$i5t /atem5ts1 ! ,food & ,drug ,adm9i/ration %all compile & ma9ta9 a li/ ( cosmetic products di/ribut$ 9 ! ,unit$ ,/ates1 includ+ ! +r$i5ts ( ea* su* product1 & %all make available su* li/ to any ,/ate1 ^u reque/4 ,in=mation disclos$ to a ,/ate t is exempt f disclosure "u section #eeb7;b77#d7 ( title #e1 ,unit$ ,/ates ,code1 %all be treat$ z a trade secret & confid5tial in=mation by ! ,/ate4 7g7 ,incomplete or inaccurate regi/ration 7#a7 ,9 g5]al ,n e>li] ?an #aj days aft] provid+ notice ( ! int5t to cancel a regi/ration & ! basis = su* cancellation1 ! ,food & ,drug ,adm9i/ration may cancel a regi/ration "u ?is section if ! ,food & ,drug ,adm9i/ration has reasonable gr\nds to believe t ! regi/ration 0 n prop]ly complet$ or updat$ 9 accordance ) ?is section or o!rwise conta9s false1 incomplete1 or inaccurate in=mation4 7#b7 ,timely update or correction ,if1 n lat] ?an #g days aft] receipt ( a notice ( int5t to cancel1 ! responsible p]son corrects ! regi/ration 9 accordance ) ! basis = ! cancellation1 & ! requir$ regi/ration fee1 if any1 is paid1 ! ,food & ,drug ,adm9i/ration %all n cancel su* regi/ration4 7h7 ,unique id5tifi] ,at ! "t ( ! initial regi/ration ( any cosmetic facility "u ?is section1 ! ,food & ,drug ,adm9i/ration %all assign a unique id5tifi] to ! facility4 7i7 ,regi/ry ( facilities 7#a7 ,9 g5]al ,! ,food & ,drug ,adm9i/ration %all compile1 ma9ta91 & update a regi/ry ( facilities t are regi/]$ "u ?is section1 & %all remove f su* regi/ry ! "n ( any facility ^: regi/ration "u ?is section is cancell$4 ,! regi/ry %all be publicly available4 7#b7 ,public availability exceptions ,in=mation d]iv$ f ! regi/ry or regi/ration docum5ts t discloses ! resid5tial address ( a regi/rant or t discloses specific facilities :]e specific cosmetic products are manufactur$ or process$ %all n be subject to disclosure "u section #eeb ( title #e1 ,unit$ ,/ates ,code4 #fjf4 ,susp5sion ( regi/ration or cosmetic +r$i5t /atem5t 7a7 ,susp5sion ( regi/ration ( a facility ,if ! ,food & ,drug ,adm9i/ration det]m9es t a cosmetic =mulation or cosmetic product manufactur$ or process$ by a regi/]$ facility & di/ribut$ 9 ! ,unit$ ,/ates has a reasonable probability ( caus+ s]i\s adv]se heal? consequ5ces or dea? to humans1 & ! ,food & ,drug ,adm9i/ration has a reasonable belief t o!r products manufactur$ or process$ by ! facility may be simil>ly affect$ because ( a failure t _c be isolat$ to a s+le product or products or is suffici5tly p]vasive to raise conc]ns ab\t o!r products manufactur$ 9 ! facility1 ! ,food & ,drug ,adm9i/ration may susp5d ! regi/ration ( a facility4 7b7 ,susp5sion ( cosmetic +r$i5t /atem5t ,if ! ,food & ,drug ,adm9i/ration det]m9es t a cosmetic product manufactur$ 9 a regi/]$ facility has a reasonable probability ( caus+ s]i\s adv]se heal? consequ5ces or dea? to humans1 ! ,food & ,drug ,adm9i/ration may susp5d ! cosmetic +r$i5t /atem5t ( t product4 7c7 ,notice ( susp5sion ,be=e susp5d+ a facility regi/ration or a cosmetic +r$i5t /atem5t "u ?is section1 ! ,food & ,drug ,adm9i/ration %all provide-- 7#a7 notice to ! facility regi/rant ( ! cosmetic product or =mulation or o!r responsible p]son1 z appropriate1 ( ! int5t to susp5d ! facility regi/ration or ! cosmetic +r$i5t /atem5t1 :i* %all specify ! basis ( ! det]m9ation by ! ,food & ,drug ,adm9i/ration t ! facility or ! cosmetic +r$i5t %\ld be susp5d$ & recomm5dations = specific actions to avoid susp5sion2 & 7#b7 an opportunity1 )9 #b bus9ess days ( ! notice provid$ "u p>agraph 7#a71 = ! responsible p]son to address ! reasons = possible susp5sion ( ! facility regi/ration or cosmetic +r$i5t /atem5t4 7d7 ,re9/atem5t ,^u a det]m9ation by ! ,food & ,drug ,adm9i/ration t adequate gr\nds d n exi/ to cont9ue ! susp5sion actions1 ! ,food & ,drug ,adm9i/ration %all promptly vacate ! susp5sion & re9/ate ! regi/ration ( ! facility or ! cosmetic +r$i5t /atem5t4 7e7 ,effect ( susp5sion 7#a7 ,regi/ration ,if ! regi/ration ( a facility is susp5d$ "u ?is section1 no p]son %all introduce or deliv] = introduction into int]/ate comm]ce cosmetics or cosmetic products f su* facility4 7#b7 ,cosmetic +r$i5t /atem5t ,if ! cosmetic +r$i5t /atem5t = a cosmetic product is susp5d$ "u ?is section1 no p]son %all introduce or deliv] = introduction into int]/ate comm]ce any cosmetic product t is ! subject ( su* /atem5t4 7f7 ,no delegation ,! au?ority conf]r$ by ?is section to issue an ord] to susp5d a regi/ration or vacate an ord] ( susp5sion %all n be delegat$ to any (fic] or employee o!r ?an ! ,commission]4 4 #ajb4 ,review ( +r$i5ts & non-functional con/itu5ts 7a7 ,am5dm5ts ,*apt] ,,vi ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cfa et seq471 z am5d$ by section #aja1 is fur!r am5d$ by add+ at ! end ! foll[+3 #fjg4 ,review ( +r$i5ts & non-functional con/itu5ts 7a7 ,+r$i5ts & non-,functional con/itu5ts subject to review 7#a7 ,9 g5]al ,beg9n+ 9 fiscal ye> #bjbj1 ! ,food & ,drug ,adm9i/ration %all review ! safety ( ! cosmetic +r$i5ts & non-functional con/itu5ts li/$ "u p>agraph 7#c71 z modifi$ "u subsection 7c71 if applicable1 & issue an ord] "u subsection 7d7 ) respect to ! use ( ea* su* +r$i5t & pres5ce ( ea* su* non-functional con/itu5t4 7#b7 ,public notice & comm5t ,at ! initiation ( ! review ( ea* cosmetic +r$i5t or non-functional con/itu5t1 ! ,food & ,drug ,adm9i/ration %all op5 a docket = ! submission ( public comm5t & additional data relevant to ! safety ( ! +r$i5t or non-functional con/itu5t4 ,! ,food & ,drug ,adm9i/ration %all provide #fj days = public comm5t4 7#c7 ,cosmetic +r$i5ts 7,a7 ,+r$i5ts to be consid]$ 9 fir/ ye> ,dur+ fiscal ye> #bjbj1 ! ,food & ,drug ,adm9i/ration %all initiate ! review = safety ( ! foll[+ cosmetic +r$i5ts3 7i7 ,diazolid9yl urea4 7ii7 ,die?yl ph?alate4 7iii7 ,me?yl5e glycol_/me?an$iol_/=maldehyde4 7iv7 ,propyl p>ab54 7v7 ,quat]nium-#ae4 7,b7 ,+r$i5ts to be consid]$ 9 subsequ5t ye>s 7i7 ,9 g5]al ,beg9n+ 9 fiscal ye> #bjba1 ! ,food & ,drug ,adm9i/ration %all annually select & complete a safety review ( at lea/ #e cosmetic +r$i5ts or non-functional con/itu5ts t 7 n review$ 9 ! prior #c ye>s1 f a li/ det]m9$ 9 consultation ) ! cosmetic indu/ry & consum] & heal? gr\ps4 ,! ,food & ,drug ,adm9i/ration may comb9e select$ cosmetics +r$i5ts or non-functional con/itu5ts into categories = purposes ( su* review4 ,! ,food & ,drug ,adm9i/ration may modify su* li/ "u subsection 7c74 7ii7 ,consid]ations ,! det]m9ation ( :i* +r$i5ts or functional +r$i5ts w be review$ 9 a giv5 ye> %all be publiciz$ 9 annual reports to ,congress & ! public1 9 accordance ) section #faf4 ,! review ( any cosmetic +r$i5t or non-functional con/itu5t %all comm5ce ) a public ann\ncem5t by ! ,food & ,drug ,adm9i/ration & ! op5+ ( a docket z requir$ "u p>agraph 7#b74 7#d7 ,comm5t p]iod ,z "p ( ! annual report+ to ,congress & ! public "u section #faf1 ! ,food & ,drug ,adm9i/ration %all solicit public comm5t on :i* cosmetic +r$i5ts or non-functional con/itu5ts on ! li/ are ( greate/ int]e/ to be review$ next = e>ly review & :i* additional cosmetic +r$i5ts or non-functional con/itu5ts %\ld be add$ to ! li/4 ,! public may submit comm5ts to ! ,food & ,drug ,adm9i/ration at any "t dur+ ! ye> reg>d+ :i* cosmetic +r$i5ts or non-functional con/itu5ts ( int]e/ ! ,food & ,drug ,adm9i/ration may consid] dur+ t ye> or subsequ5t ye>s4 7b7 ,li/ ,! ,food & ,drug ,adm9i/ration %all ma9ta9 a li/1 po/$ on ! ,int]net website ( ! ,food & ,drug ,adm9i/ration1 ( ! cosmetic +r$i5ts & non-functional con/itu5ts = :i* f9al ord]s h be5 issu$ "u subsection 7d77#c71 ! f9d+ made = ea* su* +r$i5t or non-functional con/itu5t "u subsection 7d77#d71 z modifi$ by any ord] "u subsection 7f71 if applicable1 &1 if applicable1 compliance dates t are ! subject ( a f9al ord] "u subsection 7e74 7c7 ,initiative ( ! ,,fda ,! ,food & ,drug ,adm9i/ration may at any "t propose ! issuance ( an ord] on ! safety ( a cosmetic +r$i5t or non-functional con/itu5t t 0 n previ\sly li/$ 9 subsection 7a7 or "u section #faf7;a77#c74 ,! ,food & ,drug ,adm9i/ration %all foll[ ! same proc$ures & policies = review ( any cosmetic +r$i5t or non-functional con/itu5t s propos$ z = ! +r$i5ts & con/itu5ts review$ pursuant to subsection 7a74 7d7 ,det]m9ation on safety 7#a7 ,initial propos$ adm9i/rative ord] ,foll[+ consid]ation ( data & comm5ts to ! public docket & any o!r in=mation be=e ! ,food & ,drug ,adm9i/ration1 ! ,food & ,drug ,adm9i/ration %all det]m9e :e!r !re is adequate evid5ce to make an initial f9d+ on ! safety ( ! +r$i5t or non-functional con/itu5t4 ,if ! ,food & ,drug ,adm9i/ration det]m9es t !re is adequate evid5ce1 ! ,food & ,drug ,adm9i/ration %all issue a propos$ adm9i/rative ord] & %all po/ su* ord] on ! ,int]net website ( ! ,food & ,drug ,adm9i/ration1 not)/&+ sub*apt] ,,ii ( *apt] #e ( title #e1 ,unit$ ,/ates ,code4 7#b7 ,public comm5t ,^u publication ( ! propos$ adm9i/rative ord] describ$ 9 p>agraph 7#a71 ! ,food & ,drug ,adm9i/ration %all op5 a docket = ! submission ( public comm5t4 ,! ,food & ,drug ,adm9i/ration %all provide #cj days = public comm5t foll[+ publication ( ! propos$ adm9i/rative ord]4 7#c7 ,f9al adm9i/rative ord] ,foll[+ ! public comm5t p]iod describ$ 9 p>agraph 7#b7 & consid]ation ( comm5ts to ! public docket & any o!r in=mation be=e ! ,food & ,drug ,adm9i/ration1 ! ,food & ,drug ,adm9i/ration %all det]m9e :e!r !re is adequate evid5ce to make a f9al f9d+ on ! safety ( ! +r$i5t or non-functional con/itu5t4 ,if ! ,food & ,drug ,adm9i/ration det]m9es t !re is adequate evid5ce1 ! ,food & ,drug ,adm9i/ration %all issue a f9al adm9i/rative ord] & %all po/ su* ord] on ! ,int]net website ( ! ,food & ,drug ,adm9i/ration1 not)/&+ sub*apt] ,,ii ( *apt] #e ( title #e1 ,unit$ ,/ates ,code4 7#d7 ,det]m9ations ,9 ! propos$ adm9i/rative ord] or ! f9al adm9i/rative ord]1 z applicable1 ! ,food & ,drug ,adm9i/ration %all make a det]m9ation t ! +r$i5t or non-functional con/itu5t is-- 7,a7 safe 9 cosmetic products "u specifi$ conditions ( use or tol]ances2 7,b7 safe 9 cosmetic products )\t ! ne$ = specifi$ conditions ( use or tol]ances2 or 7,c7 n safe 9 cosmetic products4 7#e7 ,conditions ( use & tol]ances ,an ord] "u p>agraph 7#d77;,a7 %all include su* conditions on ! use ( an +r$i5t or su* tol]ances on ! pres5ce ( a non-functional con/itu5t z are necess>y = ! safety ( cosmetic products conta9+ su* +r$i5t or non-functional con/itu5t1 includ+-- 7,a7 limits on ! am\nt or conc5tration ( ! +r$i5t or non-functional con/itu5t t may be pres5t 9 a cosmetic product1 includ+ limits 9 products int5d$ = *ildr5 & o!r vuln]able populations1 & limits on use ne> ! eye or mucosal membranes2 7,b7 w>n+s t are necess>y or appropriate "u section #fab1 includ+ w>n+s relat$ to use by *ildr51 pregnant wom51 populations ) high exposure to ! +r$i5t 7su* z work]s :o are expos$ ?r\gh production practices or h&l+ ( f9al products71 or o!r vuln]able populations1 to help ensure safe use ( cosmetic products conta9+ ! +r$i5t or non-functional con/itu5t2 & 7,c7 su* o!r scre5+1 safety protocol1 or o!r simil> conditions z are necess>y = ! safety ( cosmetic products conta9+ su* +r$i5t or non-functional con/itu5t4 7#f7 ,public notice ,a f9al ord] "u ?is subsection %all set =? ! det]m9ation ( ! ,food & ,drug ,adm9i/ration on safety1 any conditions ( use or tol]ances "u subp>agraph 7,a7 or 7,b7 ( p>agraph 7#d7 & a summ>y ( ! valid sci5tific evid5ce support+ ! f9d+4 ,! ord] %all be effective ^u its publication on ! ,int]net website ( ! ,food & ,drug ,adm9i/ration & %all be consid]$ f9al ag5cy action4 7e7 ,ord] 7#a7 ,9 g5]al ,if ! ,food & ,drug ,adm9i/ration issues a f9al adm9i/rative ord] "u subp>agraph 7,a7 or 7,c7 ( subsection 7d77#d71 ! ,food & ,drug ,adm9i/ration %all1 at ! same "t z publication ( ! notice "u subsection 7d77#f71 publi% a propos$ ord] id5tify+ dates by :i* use ( ! +r$i5t or non-functional con/itu5t 9 cosmetic products %all comply ) ! f9al adm9i/rative ord]1 & provide #fj days = public comm5t1 includ+ comm5t on :e!r compliance is feasible )9 ! propos$ dates4 ,aft] consid]+ comm5ts on ! propos$ ord]1 ! ,food & ,drug ,adm9i/ration %all publi% 9 ! ,f$]al ,regi/] a f9al ord]4 7#b7 ,cont5t ,! public notice in=mation reg>d+ ! f9al ord] "u p>agraph 7#a7 %all include a summ>y t is writt5 9 pla9 & und]/&able language t is compreh5sible & mean+ful = consum]s4 ,! summ>y %all include in=mation on any conditions ( use or w>n+s requir$ "u section #fab1 includ+ ! application to vuln]able populations1 ! types ( safety /udies evaluat$1 & any additional relevant in=mation t 0 "p ( ! review process4 7f7 ,modification ( an ord] ,an ord] issu$ "u subsection 7d7 or 7e7 may be modifi$ or revok$ by ! ,food & ,drug ,adm9i/ration on ! initiative ( ! ,food & ,drug ,adm9i/ration or 9 response to a petition4 7g7 ,inadequate evid5ce 7#a7 ,notice2 ,ext5sion ,if ! ,food & ,drug ,adm9i/ration det]m9es t ! available data & in=mation are n adequate to make a propos$ or f9al det]m9ation reg>d+ safety "u subsection 7d77#d71 ) respect to a cosmetic +r$i5t or non-functional con/itu5t1 ! ,food & ,drug ,adm9i/ration %all-- 7,a7 publi% su* f9d+ on ! ,int]net website ( ! ,food & ,drug ,adm9i/ration n lat] ?an #ij days aft] ! close ( ! relevant comm5t p]iod = ! +r$i5t or non-functional con/itu5t "u subsection 7a77#b71 9 ! case ( a propos$ ord]1 or subsection 7d77#b71 9 ! case ( a f9al ord]2 & 7,b7 7i7 include a notice provid+ int]e/$ p]sons an additional #cj days f ! notice date to provide additional data & in=mation2 & 7ii7 if1 aft] ! #cj-;day p]iod "u clause 7i71 ! ,food & ,drug ,adm9i/ration det]m9es t additional safety sub/antiation ) respect to su* +r$i5t or non-functional con/itu5t is necess>y to make a safety det]m9ation-- 7,i7 include a notice specify+ an additional "t p]iod1 n to exce$ #ah mon?s f ! notice date1 dur+ :i* "t ! assurance made by a responsible p]son "u section #fje7;e77#b77;,a77xii7 ) respect to ! safety ( su* cosmetic +r$i5t or non-functional con/itu5t %all be deem$ to be 9 compliance ) ! requirem5ts ( ?is ,act1 b %all n affect f9al det]m9ations ( safety "u subsection 7d72 & 7,,ii7 plan to obta9 su* data & in=mation4 7#b7 ,det]m9ation2 ,ord] 7,a7 ,inadequate data & in=mation ,if ! ,food & ,drug ,adm9i/ration det]m9es1 aft] consid]+ any additional data & in=mation submitt$ "u p>agraph 7#a77;,b71 t ! available data & in=mation /ill are n adequate to make a det]m9ation reg>d+ safety "u subsection 7d77#d71 ! ,food & ,drug ,adm9i/ration %all1 )9 #ij days ( ! close ( ! additional "t p]iod provid$ "u p>agraph 7#a77;,b71 issue a propos$ ord] or a f9al adm9i/rative ord]-- 7i7 mak+ a det]m9ation t ! +r$i5t or non-functional con/itu5t has n be5 %[n to be safe 9 cosmetic products2 & 7ii7 expla9+ :y ! available data & in=mation are n adequate to assess ! safety ( ! +r$i5t or non-functional con/itu5t4 7,b7 ,adequate data & in=mation ,if ! ,food & ,drug ,adm9i/ration det]m9es1 aft] consid]+ any additional data & in=mation submitt$ "u p>agraph 7#a77;,b71 t ! available data & in=mation are adequate to make a det]m9ation reg>d+ safety "u subsection 7d77#d71 ! ,food & ,drug ,adm9i/ration %all1 )9 #ahj days ( ! close ( ! comm5t p]iod1 issue a propos$ ord]1 foll[$ by a f9al ord]1 on su* cosmetic +r$i5t or non-functional con/itu5t1 9 accordance ) su* subsection4 7h7 ,safety assessm5t 7#a7 ,9 g5]al ,9 assess+ ! safety ( an +r$i5t or non-functional con/itu5t1 ! ,food & ,drug ,adm9i/ration %all consid] :e!r !re is adequate evid5ce to support a reasonable c]ta9ty among compet5t sci5ti/s t ! +r$i5t is n h>mful "u ! recomm5d$ or sugge/$ conditions ( use or cu/om>y or usual use1 or t a non-functional con/itu5t is n h>mful "u ! recomm5d$ or sugge/$ tol]ance levels or ! level at :i* x is cu/om>ily or usually pres5t4 ,! ,food & ,drug ,adm9i/ration may n consid] an +r$i5t or non-functional con/itu5t h>mful solely because x c cause m9or adv]se heal? reactions1 su* z m9or transi5t all]gic reactions or m9or transi5t sk9 irritations1 9 "s us]s4 7#b7 ,factors ,9 assess+ ! safety ( an +r$i5t or non-functional con/itu5t1 ! ,food & ,drug ,adm9i/ration %all consid]1 among o!r relevant factors1 ! foll[+3 7,a7 ,! probable human exposure to ! +r$i5t or non-functional con/itu5t f expect$ use 9 cosmetics4 7,b7 ,! probable cumulative & aggregate effect 9 humans ( relevant exposure to ! +r$i5t or non-functional con/itu5t or to any *emically or ph>macologically relat$ sub/ances f use 9 cosmetics or o!r products ) simil> r\tes ( exposure "u recomm5d$ or sugge/$ conditions ( use or _! cu/om>y use1 to ! ext5t adequate data is available = analysis4 ,9 appropriate cases1 ! ,food & ,drug ,adm9i/ration may consid] available in=mation on ! total exposure to an +r$i5t or non-functional con/itu5t f all s\rces4 7,c7 ,:e!r w>n+s or recomm5dations 9 a product label requir$ "u section #fab1 z "p ( any conditions ( use or tol]ances impos$ by ! ,food & ,drug ,adm9i/ration1 w\ld be necess>y & appropriate to help ensure ! safety ( ! +r$i5t or non-functional con/itu5t4 7#c7 ,data & in=mation 7,a7 ,requir$ in=mation ,a det]m9ation t an +r$i5t or non-functional con/itu5t is safe 9 cosmetics %all be bas$ ^u adequate evid5ce submitt$ or o!rwise kn[n to ! ,food & ,drug ,adm9i/ration1 :i* %all include full reports ( all available /udies1 publi%$ or unpubli%$1 t are adequately design$ to %[ :e!r ! +r$i5t or non-functional con/itu5t is safe4 ,su* /udies may include 9 vitro & 9 silico /udies & epidemiological /udies1 biomonitor+ /udies1 & /udies focus$ on v>i\s po9ts dur+ ! lifespan ( ! subject1 t use sci5tifically valid me?odology4 7,b7 ,additional relevant in=mation ,! ,food & ,drug ,adm9i/ration %all consid] any o!r relevant in=mation relat$ to ! safety ( ! +r$i5t or non-functional con/itu5t1 includ+-- 7i7 adv]se ev5t reports2 7ii7 f9d+s & in=mation f ,/ate1 ,f$]al1 national1 & int]national entities & o!r bodies compos$ ( sci5tific & m$ical exp]ts2 7iii7 if ! +r$i5t or non-functional con/itu5t is lawfully us$ or pres5t 9 o!r products regulat$ by ! ,food & ,drug ,adm9i/ration1 ! sci5tific basis = su* use2 & 7iv7 exp]i5ce ) ! +r$i5t or non-functional con/itu5t 9 products t are di/ribut$ 9 ! ,unit$ ,/ates or 9 o!r c\ntries1 if su* exp]i5ce is well-docum5t$ & has result$ 9 sub/antial human exposure to ! +r$i5t or non-functional con/itu5t ov] "t4 7i7 ,coal-,t> ,hair ,dye ,coal-t> hair dye %all be subject to ! conditions ( section #fja7;a7 unless ! ,food & ,drug ,adm9i/ration has issu$ a f9al det]m9ation = a coal-t> hair dye +r$i5t "u subsection 7d77#d77;,c74 4 #ajc4 ,good manufactur+ practices = cosmetics 7a7 ,9 g5]al ,*apt] ,,vi ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cfa et seq471 z am5d$ by section #ajb1 is fur!r am5d$ by add+ at ! end ! foll[+3 #fjh4 ,good manufactur+ practices = cosmetics 7a7 ,9 g5]al ,! ,food & ,drug ,adm9i/ration %all review national & int]national /&>ds = cosmetic good manufactur+ practices t are 9 exi/5ce on ! date ( enactm5t ( ! ,p]sonal ,c>e ,products ,safety ,act & %all develop & implem5t1 ?r\gh regulations1 /&>ds consi/5t1 to ! ext5t ! ,food & ,drug ,adm9i/ration det]m9es practicable & appropriate1 ) su* national & int]national /&>ds = cosmetic good manufactur+ practices to ensure t requirem5ts ( ?is *apt] ) respect to ! manufacture ( cosmetic products are 9 h>mony4 7b7 ,consultation ,! /&>ds "u subsection 7a7 %all include simplifi$ good manufactur+ practices = small bus9esses t take into acc\nt ! size & scope ( ! bus9ess1 develop$ 9 consultation ) ! ,small ,bus9ess ,adm9i/ration4 7c7 ,timeframe ,! ,food & ,drug ,adm9i/ration %all publi% a propos$ rule describ$ 9 subsection 7a7 n lat] ?an #ah mon?s aft] ! date ( enactm5t ( ! ,p]sonal ,c>e ,products ,safety ,act & %all publi% a f9al su* rule n lat] ?an #c ye>s aft] su* date ( enactm5t4 4 7b7 ,effective date = cosmetic manufactur]s 7#a7 ,l>ge bus9esses ,= bus9esses ( a size great] ?an ! ,small ,bus9ess ,adm9i/ration's /&>d = a small bus9ess1 section #fjh ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7z add$ by subsection 7a77 %all take effect beg9n+ #ahj days aft] ! date on :i* ! ,food & ,drug ,adm9i/ration makes effective cosmetic good manufactur+ practices4 7#b7 ,small bus9esses ,= bus9esses ( a size t meets ! ,small ,bus9ess ,adm9i/ration's /&>d = a small bus9ess1 section #fjh ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7z add$ by subsection 7a77 %all take effect beg9n+ #b ye>s aft] ! date ! ,food & ,drug ,adm9i/ration makes effective cosmetic good manufactur+ practices4 #ajd4 ,adv]se ev5t reports ,*apt] ,,vi ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cfa et seq471 z am5d$ by section #ajc7;a71 is fur!r am5d$ by add+ at ! end ! foll[+3 #fji4 ,adv]se ev5t report+ = cosmetics 7a7 ,9 g5]al ,) respect to any cosmetic product di/ribut$ 9 ! ,unit$ ,/ates1 ! responsible p]son %all submit to ! ,food & ,drug ,adm9i/ration a report ( any s]i\s adv]se ev5t associat$ ) su* cosmetic product1 :5 us$ 9 ! ,unit$ ,/ates1 accompani$ by a copy ( ! label on or ) ! retail packag+ ( ! cosmetic1 any new m$ical in=mation1 relat$ to a submitt$ s]i\s adv]se ev5t report t is receiv$ by ! responsible p]son1 & an annual report = all adv]se ev5ts receiv$ by ! responsible p]son4 7b7 ,def9itions ,9 ?is section3 7#a7 ,an adv]se ev5t = a cosmetic product is a heal?-relat$ ev5t associat$ ) ! use ( ?is product t is adv]se4 7#b7 ,a s]i\s adv]se ev5t = a cosmetic product is an adv]se ev5t t-- 7,a7 results 9-- 7i7 dea?2 7ii7 a life-?reat5+ exp]i5ce2 7iii7 inpati5t hospitalization2 7iv7 a p]si/5t or significant disability or incapacity2 7v7 cong5ital anomaly or bir? defect2 or 7vi7 significant disfigurem5t1 includ+ s]i\s & p]si/5t ra%es or infections & significant hair loss2 or 7,b7 requires1 bas$ on appropriate m$ical judgm5t1 a m$ical or surgical int]v5tion to prev5t an outcome describ$ 9 subp>agraph 7,a74 7c7 ,submission ( reports 7#a7 ,s]i\s adv]se ev5t reports ,except z provid$ 9 p>agraph 7#b71 ) respect to a cosmetic product di/ribut$ 9 ! ,unit$ ,/ates1 ! responsible p]son %all submit a s]i\s adv]se ev5t report to ! ,food & ,drug ,adm9i/ration n lat] ?an #ae bus9ess days aft] in=mation conc]n+ ! adv]se ev5t is receiv$4 ,if a s]i\s adv]se ev5t report = a cosmetic ) drug prop]ties is fil$ us+ ,=m ,,fda #cejj;,a 7or any successor =m develop$ = su* purpose7 or its electronic equival5t = ov]-!-c\nt] drugs1 ! responsible p]son %all n h to submit a duplicative s]i\s adv]se ev5t report "u ?is section4 7#b7 ,new m$ical in=mation ,! responsible p]son %all submit to ! ,food & ,drug ,adm9i/ration any new m$ical in=mation1 relat$ to a submitt$ s]i\s adv]se ev5t report t is receiv$ by ! responsible p]son )9 #a ye> ( ! initial report1 & %all submit su* in=mation n lat] ?an #ae bus9ess days aft] ! new in=mation is receiv$ by ! responsible p]son4 7#c7 ,consolidation ( reports ,! ,food & ,drug ,adm9i/ration %all provide = sy/ems to enable ! responsible p]son to submit a s+le report t includes duplicate reports (1 or new m$ical in=mation relat$ to1 a s]i\s adv]se ev5t4 7#d7 ,annual report 7,a7 ,9 g5]al ,n lat] ?an ,m>* #a ( ea* ye>1 except z provid$ "u subp>agraph 7,c71 ! responsible p]son %all submit an electronic report = ! prior cal5d> ye> = ea* cosmetic product m>ket$ dur+ t ye>4 7,b7 ,cont5ts ,ea* report "u ?is p>agraph %all conta9 a summ>y ( all adv]se ev5ts receiv$ dur+ ! report+ p]iod1 a complete li/ ( individual reports1 & an e/imate ( ! total numb] ( product units e/imat$ to h be5 di/ribut$ to consum]s 9 ! ,unit$ ,/ates dur+ su* p]iod4 ,! report %all n include consum] compla9ts t are solely reg>d+ efficacy & d n conta9 any in=mation ab\t an adv]se ev5t4 ,! ,food & ,drug ,adm9i/ration %all fur!r specify ! cont5ts ( ! annual electronic report by regulation or guidance4 7,c7 ,small bus9ess exception ,9 ! case ( a dome/ic facility = :i* ! av]age gross annual sales 9 cosmetic products 9 ! ,unit$ ,/ates ov] ! previ\s #c-ye> p]iod is n m ?an #b1jjj1jjj1 ! responsible p]son is n requir$ to submit an annual report "u ?is p>agraph4 7#e7 ,exemption ,! ,food & ,drug ,adm9i/ration may e/abli% by regulation an exemption to any ( ! requirem5ts "u ?is subsection if ! ,food & ,drug ,adm9i/ration det]m9es t su* exemption is support$ by adequate evid5ce & w\ld h no adv]se effect on public heal?4 7d7 ,requirem5ts 7#a7 ,9 g5]al ,ea* s]i\s adv]se ev5t report "u ?is section %all be submitt$ to ! ,food & ,drug ,adm9i/ration us+ an electronic sy/em ( ! ,food & ,drug ,adm9i/ration4 ,! ,food & ,drug ,adm9i/ration %all make su* electronic sy/em available n lat] ?an #a ye> aft] ! date ( enactm5t ( ! ,p]sonal ,c>e ,products ,safety ,act4 7#b7 ,modification ,! =mat ( ! report+ sy/em may be modifi$ by ! ,food & ,drug ,adm9i/ration & ! reports may include additional in=mation4 ,! ,food & ,drug ,adm9i/ration may1 9 guidance1 fur!r specify ! =mat & cont5ts ( requir$ reports4 7#c7 ,scope ( s]i\s adv]se ev5t report ,a s]i\s adv]se ev5t report 7includ+ all in=mation submitt$ 9 ! initial report or add$ lat]7 submitt$ to ! ,food & ,drug ,adm9i/ration "u subsection 7a7 includes-- 7,a7 a report "u section #gef ) respect to safety & relat$ to a specific cosmetic product2 7,b7 a record ab\t an individual :o suff]$ ! s]i\s adv]se ev5t "u section #eeb;a ( title #e1 ,unit$ ,/ates ,code2 7,c7 a m$ical or simil> file docum5t+ ! s]i\s adv]se ev5t1 ! disclosure ( :i* w\ld con/itute a violation ( section #eeb7;b77#f7 ( su* title #e1 & %all n be publicly disclos$ unless all p]sonally id5tifiable in=mation is r$act$2 & 7,d7 contact in=mation = ! individual report+ ! s]i\s adv]se ev5t4 7#d7 ,responsibility to ga!r in=mation ,aft] an individual initiates ! report+ ( a s]i\s adv]se ev5t1 ! responsible p]son = ! cosmetic product %all actively ga!r all ( ! in=mation to complete & file ! report ) ! ,food & ,drug ,adm9i/ration4 7#e7 ,no adv]se ev5ts to report ,! ,food & ,drug ,adm9i/ration %all provide an option z "p ( ! electronic regi/ration process = ! responsible p]son to indicate if su* responsible p]son _h no adv]se ev5ts to report ov] ! previ\s ye>4 ,) respect to a responsible p]son :o receiv$ no adv]se ev5t reports = a ye>1 ! annual adv]se ev5t report requirem5t may be met by indicat+ no su* ev5ts on ! annual regi/ration =m4 7e7 ,limitation ) respect to adv]se ev5t reports ,! submission ( an adv]se ev5t report 9 compliance ) subsection 7a7 %all n con/itute an admission t ! cosmetic involv$ caus$ or contribut$ to ! adv]se ev5t4 7f7 ,contact in=mation ,! label ( a cosmetic %all be> ! dome/ic telephone numb] or electronic contact in=mation1 & x is enc\rag$ t ! label include bo? ! telephone numb] & electronic contact in=mation1 ?r\gh :i* ! responsible p]son may receive a report ( an adv]se ev5t4 7g7 ,ma9t5ance ( records ,! responsible p]son %all ma9ta9 records relat$ to ea* report ( an adv]se ev5t receiv$ by ! responsible p]son = a p]iod ( #f ye>s4 7h7 ,availability to ,/ates ,! ,food & ,drug ,adm9i/ration %all make available records submitt$ "u ?is section to any ,/ate1 ^u reque/4 ,in=mation disclos$ to a ,/ate t is exempt f disclosure "u section #eeb7;b77#d7 ( title #e1 ,unit$ ,/ates ,code1 %all be treat$ z a trade secret & confid5tial in=mation by ! ,/ate4 7i7 ,effective date ( requirem5t ) respect to s]i\s adv]se ev5ts ,! requirem5t "u ?is section to report s]i\s adv]se ev5ts %all become effective on ! date t ! ,food & ,drug ,adm9i/ration publicizes ! availability ( ! electronic sy/em describ$ 9 subsection 7d77#a74 4 #aje4 ,records inspection2 m&atory recall au?ority ,*apt] ,,vi ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cfa et seq471 z am5d$ by section #ajd1 is fur!r am5d$ by add+ at ! end ! foll[+3 #faj4 ,inspection ( cosmetic records 7a7 ,inspection ( records ,ea* manufactur] or processor ( a cosmetic %all1 at ! reque/ ( an (fic] or employee duly designat$ by ! ,food & ,drug ,adm9i/ration1 p]mit su* (fic] or employee1 ^u pres5tation ( appropriate cr$5tials & writt5 notice to su* p]son1 at reasonable times & )9 reasonable limits & 9 a reasonable mann]1 to h access to & copy-- 7#a7 all records ma9ta9$ "u section #fje7;e77#b77;,a77xii7 or #fji & 9 accordance ) ! rules promulgat$ by ! ,food & ,drug ,adm9i/ration "u section #fjh1 z applicable2 & 7#b7 except z provid$ 9 subsection 7b71 all o!r records1 if ! ,food & ,drug ,adm9i/ration-- 7,a7 has a reasonable belief t ! cosmetic-- 7i7 is adult]at$2 7ii7 has caus$ a reportable s]i\s adv]se ev5t2 or 7iii7 conta9s an +r$i5t t sub/antial new sci5tific in=mation %[s may be unsafe :5 pres5t 9 a cosmetic2 & 7,b7 provides writt5 notice ( ! basis = ! ,food & ,drug ,adm9i/ration's reasonable belief describ$ 9 subp>agraph 7,a74 7b7 ,exclusions ,no inspection au?oriz$ by ?is section %all ext5d to f9ancial data1 pric+ data1 p]sonnel data 7o!r ?an data z to qualification ( te*nical & pr(essional p]sonnel p]=m+ functions subject to ?is ,act71 rese>* data 7o!r ?an safety data71 or sales data o!r ?an %ipm5t data4 7c7 ,scope ,! requirem5ts "u subsection 7a7 apply to records ma9ta9$ by or on behalf ( su* p]son 9 any =mat 7includ+ pap] & electronic =mats7 & at any location4 7d7 ,protection ( s5sitive in=mation ,! ,food & ,drug ,adm9i/ration %all take appropriate measures to ensure t !re are effective proc$ures to prev5t ! unau?oriz$ disclosure ( any trade secret or confid5tial in=mation t is obta9$ by ! ,food & ,drug ,adm9i/ration pursuant to ?is section4 ,in=mation disclos$ to a ,/ate t is exempt f disclosure "u section #eeb7;b77#d7 ( title #e1 ,unit$ ,/ates ,code1 %all be treat$ z a trade secret & confid5tial in=mation by ! ,/ate4 7e7 ,limitations ,?is section %all n be con/ru$-- 7#a7 to limit ! au?ority ( ! ,food & ,drug ,adm9i/ration to inspect records or to require e/abli%m5t & ma9t5ance ( records "u any o!r provision ( ?is ,act2 or 7#b7 to h any legal effect on section #eeb ( title #e1 ,unit$ ,/ates ,code1 or section #aije ( title #ah1 ,unit$ ,/ates ,code4 7f7 ,submission ( records 7#a7 ,9 g5]al ,any records requir$ to be ma9ta9$ by a responsible p]son "u section #fje7;e77#b77;,a77xii7 %all1 ^u ! writt5 reque/ ( ! ,food & ,drug ,adm9i/ration to ! responsible p]son1 be provid$ to ! ,food & ,drug ,adm9i/ration )9 a reasonable timeframe n to exce$ #fj days1 9 ei!r electronic or pap] =m4 7#b7 ,crit]ia ,! ,food & ,drug ,adm9i/ration may require records "u p>agraph 7#a7 if-- 7,a7 ! ,food & ,drug ,adm9i/ration has a reasonable belief1 describ$ 9 writt5 notice1 t-- 7i7 ! f9i%$ product may be h>mful bas$ on adv]se ev5t reports or o!r sci5tific in=mation2 or 7ii7 sci5tific in=mation raises cr$ible & relevant que/ions ab\t ! safety ( ! product or any ( its +r$i5ts2 7,b7 ! ,food & ,drug ,adm9i/ration1 an exp]t regulatory body1 or an exp]t body compos$ ( sci5tific & m$ical exp]ts f9ds an +r$i5t 9 ! product to be unsafe "u ! conditions ( use ( ! product2 or 7,c7 ! ,food & ,drug ,adm9i/ration concludes t submission ( ! records w s]ve ! public heal? or o!rwise enable ! ,food & ,drug ,adm9i/ration to fulfill ! cosmetic safety purposes ( ?is section4 4 #faa4 ,m&atory recall au?ority 7a7 ,volunt>y proc$ures ,if ! ,food & ,drug ,adm9i/ration det]m9es t !re is a reasonable probability t a cosmetic is adult]at$ "u section #fja or misbr&$ "u section #fjb & ! use ( or exposure to su* cosmetic is likely to cause s]i\s adv]se heal? consequ5ces or dea?1 ! ,food & ,drug ,adm9i/ration %all provide ! responsible p]son ) an opportunity to volunt>ily cease di/ribution & recall su* article4 7b7 ,prehe>+ ord] ,to m&atorily cease di/ribution & give notice 7#a7 ,9 g5]al ,if ! responsible p]son refuses to or does n volunt>ily cease di/ribution or recall su* cosmetic )9 ! "t & 9 ! mann] prescrib$ by ! ,food & ,drug ,adm9i/ration1 ! ,food & ,drug ,adm9i/ration may ord] su* p]son to-- 7,a7 imm$iately cease di/ribution ( su* cosmetic2 & 7,b7 z applicable1 imm$iately notify all p]sons-- 7i7 manufactur+1 process+1 pack+1 transport+1 hold+1 receiv+1 di/ribut+1 or import+ & sell+ su* cosmetic2 & 7ii7 to :i* su* cosmetic has be5 di/ribut$1 transport$1 or sold 7except consum]s71 to imm$iately cease di/ribution ( su* cosmetic4 7#b7 ,requir$ additional in=mation 7,a7 ,9 g5]al ,if a cosmetic cov]$ by a recall ord] issu$ "u p>agraph 7#a77;,b7 has be5 di/ribut$ to a w>eh\se-bas$ ?ird-p>ty logi/ics provid] )\t provid+ su* provid] suffici5t in=mation to "k or reasonably det]m9e ! precise id5tity ( su* cosmetic cov]$ by a recall ord] t is 9 its possession1 ! notice provid$ by ! responsible p]son subject to ! ord] issu$ "u p>agraph 7#a77;,b7 %all include su* in=mation z is necess>y = ! w>eh\se-bas$ ?ird-p>ty logi/ics provid] to id5tify ! cosmetic4 7,b7 ,rules ( con/ruction ,no?+ 9 ?is p>agraph %all be con/ru$-- 7i7 to exempt a w>eh\se-bas$ ?ird-p>ty logi/ics provid] f ! requirem5ts ( ?is *apt]1 includ+ ! requirem5ts ( ?is section & section #faj2 or 7ii7 to exempt a w>eh\se-bas$ ?ird-p>ty logi/ics provid] f be+ ! subject ( a m&atory recall ord]4 7#c7 ,det]m9ation to limit areas affect$ ,if ! ,food & ,drug ,adm9i/ration requires a responsible p]son to cease di/ribution "u p>agraph 7#a77;,a7 ( a cosmetic1 ! ,food & ,drug ,adm9i/ration may limit ! size ( ! geographic area & ! m>kets affect$ by su* cessation if su* limitation w\ld n compromise ! public heal?4 7c7 ,he>+ on ord] ,! ,food & ,drug ,adm9i/ration %all provide ! responsible p>ty subject to an ord] "u subsection 7b7 ) an opportunity = an in=mal he>+1 to be held z soon z possible1 b n lat] ?an #b days aft] ! issuance ( ! ord]1 on ! actions requir$ by ! ord] & on :y ! cosmetic t is ! subject ( ! ord] %\ld n be recall$4 7d7 ,po/-,he>+ recall ord] & modification ( ord] 7#a7 ,am5dm5t ( ord] ,if1 aft] provid+ opportunity = an in=mal he>+ "u subsection 7c71 ! ,food & ,drug ,adm9i/ration det]m9es t removal ( ! cosmetic f comm]ce is necess>y1 ! ,food & ,drug ,adm9i/ration %all1 z appropriate-- 7,a7 am5d ! ord] to require recall ( su* cosmetic or o!r appropriate action2 7,b7 specify a timetable 9 :i* ! recall %all occur2 7,c7 require p]iodic reports to ! ,food & ,drug ,adm9i/ration describ+ ! progress ( ! recall2 & 7,d7 provide notice to consum]s to :om su* cosmetic 01 or may h be51 di/ribut$4 7#b7 ,vacat+ ( ord] ,if1 aft] su* he>+1 ! ,food & ,drug ,adm9i/ration det]m9es t adequate gr\nds d n exi/ to cont9ue ! actions requir$ by ! ord]1 or t su* actions %\ld be modifi$1 ! ,food & ,drug ,adm9i/ration %all vacate ! ord] or modify ! ord]4 7e7 ,coop]ation & consultation ,! ,food & ,drug ,adm9i/ration %all "w ) ,/ate & local public heal? (ficials 9 c>ry+ out ?is section1 z appropriate4 7f7 ,public notification ,9 conduct+ a recall "u ?is section1 ! ,food & ,drug ,adm9i/ration %all-- 7#a7 ensure t a press release is publi%$ reg>d+ ! recall1 & t al]ts & public notices are issu$1 z appropriate1 9 ord] to provide notification-- 7,a7 ( ! recall to consum]s & retail]s to :om su* cosmetic 01 or may h be51 di/ribut$2 & 7,b7 t includes1 at a m9imum-- 7i7 ! "n ( ! cosmetic subject to ! recall2 7ii7 a description ( ! risk associat$ ) su* article2 & 7iii7 to ! ext5t practicable1 in=mation = consum]s ab\t simil> cosmetics t are n affect$ by ! recall2 & 7#b7 ensure publication on ! ,int]net website ( ! ,food & ,drug ,adm9i/ration ( an image ( ! cosmetic t is ! subject ( ! press release describ$ 9 p>agraph 7#a71 if available4 7g7 ,no delegation ,! au?ority conf]r$ by ?is section to ord] a recall or vacate a recall ord] %all n be delegat$ to any (fic] or employee o!r ?an ! ,commission]4 7h7 ,effect ,no?+ 9 ?is section %all affect ! au?ority ( ! ,food & ,drug ,adm9i/ration to reque/ or p>ticipate 9 a volunt>y recall1 or to issue an ord] to cease di/ribution or to recall "u any o!r provision ( ?is *apt] or "u ! ,public ,heal? ,s]vice ,act4 4 #ajf4 ,label+ 7a7 ,9 g5]al ,*apt] ,,vi ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cfa et seq471 z am5d$ by section #aje1 is fur!r am5d$ by add+ at ! end ! foll[+3 #fab4 ,label+ 7a7 ,safety review & label+ ,foll[+ a review ( cosmetic +r$i5ts t det]m9es t w>n+s are requir$ to help ensure safe use ( cosmetic products "u section #fjg7;d77#e71 ! ,food & ,drug ,adm9i/ration %all require label+ ( cosmetics t are n appropriate = use 9 ! entire population1 includ+ w>n+s t vuln]able populations1 su* z *ildr5 or pregnant wom51 %\ld limit or avoid us+ ! product4 7b7 ,cosmetic products = pr(essional use 7#a7 ,def9ition ( pr(essional ,= purposes ( ?is section1 ) respect to cosmetics1 ! t]m pr(essional means an individual :o-- 7,a7 is lic5s$ by an (ficial ,/ate au?ority to practice 9 ! field ( cosmetology1 nail c>e1 b>b]+1 or e/hetics2 7,b7 has compli$ ) all requirem5ts set =? by ! ,/ate = su* lic5s+2 & 7,c7 has be5 grant$ a lic5se by a ,/ate bo>d or legal ag5cy or legal au?ority4 7#b7 ,li/+ ( +r$i5ts ,cosmetic products us$ & sold by pr(essionals %all li/ all +r$i5ts & w>n+s1 z requir$ = o!r cosmetic products "u ?is *apt]4 7#c7 ,pr(essional use label+ ,9 ! case ( a cosmetic product int5d$ to be us$ only by a pr(essional on acc\nt ( a specific +r$i5t or increas$ conc5tration ( an +r$i5t t requires safe h&l+ by tra9$ pr(essionals1 ! product %all be> a /atem5t z foll[s3 ,to be ,adm9i/]$ ,only by ,lic5s$ ,pr(essionals4 7c7 ,requirem5ts 7#a7 ,display ,a w>n+ requir$ "u subsection 7a7 & a /atem5t requir$ "u subsection 7b77#c7 %all be prom95tly display$-- 7,a7 9 ! prim>y language us$ on ! label2 & 7,b7 9 conspicu\s & legible type 9 contra/ by typography1 lay\t1 or color ) o!r mat]ial pr9t$ or display$ on ! label4 7#b7 ,m9imum w>n+ requirem5ts ,a responsible p]son may include on ! label+ any additional w>n+s 9 addition to ! m9imum w>n+s requir$ "u subsection 7a74 7d7 ,int]net sales ,9 ! case ( ,int]net sales ( cosmetics1 ea* ,int]net website (f]+ a cosmetic product = sale to consum]s %all provide ! same in=mation t is includ$ on ! packag+ ( ! cosmetic product z regul>ly available ?r\gh 9-p]son sales1 except in=mation t is unique to a s+le cosmetic product sold 9 a retail facility1 su* z a lot numb] or expiration date1 & ! w>n+s & /atem5ts describ$ 9 subsection 7c7 %all be prom95tly & conspicu\sly display$ on ! website4 7e7 ,contact in=mation ,! label on ea* cosmetic %all be> ! dome/ic telephone numb] or electronic contact in=mation1 & x is enc\rag$ t ! label include bo? ! telephone numb] & electronic contact in=mation1 t consum]s may use to contact ! responsible p]son ) respect to adv]se ev5ts4 ,! contact numb] %all provide a means = consum]s to obta9 additional in=mation ab\t +r$i5ts 9 a cosmetic1 includ+ ! ability to ask if a specific +r$i5t may be pres5t t is n li/$ on ! label1 includ+ :e!r a specific +r$i5t may be conta9$ 9 ! fragrance or flavor us$ 9 ! cosmetic4 ,! manufactur] ( ! cosmetic is responsible = provid+ su* in=mation1 includ+ obta9+ ! in=mation f suppli]s if x is n readily available4 ,suppli]s are requir$ to release su* in=mation ^u reque/ ( ! cosmetic manufactur]4 4 7b7 ,effective date ,section #fab ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act1 z add$ by subsection 7a71 %all take effect on ! date t is #a ye> aft] ! date ( enactm5t ( ?is ,act4 #ajg4 ,coal t> *emicals ,*apt] ,,vi ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cfa et seq471 z am5d$ by section #ajf1 is fur!r am5d$ by add+ at ! end ! foll[+3 #fac4 ,coal t> *emicals ,specific +r$i5ts 9 coal t> hair dyes may be select$ & review$ "u section #fjg4 ,if ! ,food & ,drug ,adm9i/ration reviews a coal-t> +r$i5t f\nd 9 hair dye & makes a safety det]m9ation "u section #fjg7;d7 = su* +r$i5t1 su* det]m9ation %all include consid]ation = ! safe use ( su* +r$i5t ?r\gh appropriate conditions ( use1 :i* may include a specific label requirem5t1 specifi$ limits ( conc5trations1 or o!r su* conditions ( use z ! ,food & ,drug ,adm9i/ration det]m9es appropriate1 includ+ a f9d+ ( n safe "u any conditions if appropriate4 4 #ajh4 ,s5se ( ! ,s5ate on animal te/+ 7a7 ,animal te/+ ,*apt] ,,vi ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cfa et seq471 z am5d$ by section #ajg1 is fur!r am5d$ by add+ ! foll[+3 #fad4 ,animal te/+ ,x is ! s5se ( ! ,s5ate t animal te/+ %\ld n be us$ = ! purposes ( safety te/+ on cosmetic products & %\ld be phas$ out ) ! exception ( appropriate all[ances4 4 #aji4 ,preemption ,*apt] ,,vi ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cfa et seq471 z am5d$ by section #ajh1 is fur!r am5d$ by add+ ! foll[+3 #fae4 ,preemption 7a7 ,9 g5]al ,no ,/ate or political subdivision ( a ,/ate may e/abli% or cont9ue 9 effect any requirem5t = cosmetics1 o!r ?an a requirem5t t is 9 full effect & implem5t$ on ! date ( enactm5t ( ! ,p]sonal ,c>e ,products ,safety ,act-- 7#a7 ) respect to regi/ration1 good manufactur+ practices1 m&atory recalls1 or adv]se ev5t report+2 or 7#b7 ) respect to ! safety ( a cosmetic +r$i5t or non-functional con/itu5t t is ! subject ( a f9al ord] on a det]m9ation ( safety "u ?is *apt]1 unless ! requirem5t ( ! ,/ate or political subdivision is m re/rictive ?an ! f9al ord] "u section #fjg7;d77#c74 7b7 ,safety ( cosmetic +r$i5ts & non-,functional con/itu5ts 7#a7 ,delay$ effect ( new ,/ate requirem5ts 7,a7 ,9 g5]al ,f ! date t ! ,food & ,drug ,adm9i/ration has made public ! f9al selection ( a cosmetic +r$i5t or non-functional con/itu5t to be review$ 9 ! com+ ye> "u section #fjg7;a77#c77;,b7 & op5$ ! public comm5t p]iod "u section #fjg7;a77#b71 until ! date t is "o ye> aft] ! ,food & ,drug ,adm9i/ration has made public su* selection1 no ,/ate or political subdivision ( a ,/ate may e/abli% any new requirem5t relat$ to su* cosmetic +r$i5t or non-functional con/itu5t4 7,b7 ,initial review ,) respect to ! cosmetic +r$i5ts to be review$ 9 ! fir/ ye>1 9 accordance ) section #fjg7;a77#c77;,a71 = ! #a-ye> p]iod beg9n+ on ! date t is #f mon?s aft] ! date ( enactm5t ( ! ,p]sonal ,c>e ,products ,safety ,act1 no ,/ate or political subdivision ( a ,/ate may e/abli% any new requirem5t relat$ to su* cosmetic +r$i5t or non-functional con/itu5t4 7#b7 ,scope ,subsection 7a77#b7 %all n be con/ru$ to affect ! au?ority ( a ,/ate or political subdivision ( a ,/ate ) respect to any requirem5t = ! safety ( a cosmetic +r$i5t or non-functional con/itu5t t is unrelat$ to ! scope ( ! safety assessm5t "u section #fjg4 7#c7 ,s5se ( ,congress ,x is ! s5se ( ,congress t a ,/ate or political subdivision t regulates ! safety ( cosmetics ) respect to ! heal? ( humans beyond ! scope ( section #fjg %\ld utilize ! safety assessm5t crit]ia describ$ 9 section #fjg7;h74 7c7 ,/ate requirem5t t is 9 full effect & implem5t$ ,= purposes ( ?is section3 7#a7 ,/ate requirem5t ,a ,/ate requirem5t includes a ,/ate requirem5t t is adopt$ by a ,/ate public initiative or ref]5dum4 7#b7 ,full effect & implem5t$ ,! t]m full effect & implem5t$ includes requirem5ts ( ,/ates t are implem5t$ aft] ! date ( enactm5t ( ! ,p]sonal ,c>e ,products ,safety ,act1 if su* requirem5ts are "u a law t 0 9 effect1 or a lawful program t 0 e/abli%$ & function+1 prior to ! date ( enactm5t ( ! ,p]sonal ,c>e ,products ,safety ,act4 7d7 ,limitation ,no?+ 9 ! am5dm5ts to ?is ,act made by ! ,p]sonal ,c>e ,products ,safety ,act %all be con/ru$ to preempt any ,/ate /atute1 public initiative1 ref]5dum1 or o!r ,/ate action1 except z expressly provid$ 9 ?is section4 7e7 ,sav+s ,no?+ 9 ! am5dm5ts to ?is ,act made by ! ,p]sonal ,c>e ,products ,safety ,act1 nor any /&>d1 rule1 requirem5t1 regulation1 adv]se ev5t report1 safety assessm5t1 safety det]m9ation1 sci5tific assessm5t1 or ord] issu$ or implem5t$ pursuant to su* am5dm5ts1 %all be con/ru$ to modify or o!rwise affect1 preempt1 or displace any cause ( action or ,/ate or ,f$]al law creat+ a rem$y = civil relief or crim9al cause ( action1 :e!r /atutory or bas$ 9 common law4 7f7 ,s5se ( ! ,s5ate ,x is ! s5se ( ! ,s5ate t subsection 7e7 does n negate ! o!r provisions ( ?is section4 4 #aaj4 ,report+ ,*apt] ,,vi ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cfa et seq471 z am5d$ by section #aji1 is fur!r am5d$ by add+ at ! end ! foll[+3 #faf4 ,report+ 7a7 ,p]=mance report ,beg9n+ ) fiscal ye> #bjbj1 & n lat] ?an #fj days prior to ! end ( ea* fiscal ye> = :i* fees are collect$ "u section #gdd,l1 ! ,food & ,drug ,adm9i/ration %all prep>e & submit to ,congress a report conc]n+ ! progress ( ! ,food & ,drug ,adm9i/ration 9 a*iev+ ! objectives ( ! ,p]sonal ,c>e ,products ,safety ,act dur+ su* fiscal ye> & ! future plans ( ! ,food & ,drug ,adm9i/ration = meet+ ! objectives4 ,! annual report = a fiscal ye> %all include-- 7#a7 ! numb] ( regi/]$ facilities & cosmetic +r$i5t /atem5ts on file ) ! ,food & ,drug ,adm9i/ration2 7#b7 id5tification ( ! cosmetic +r$i5ts & non-functional con/itu5ts t h be5 fully review$ = safety by ! ,food & ,drug ,adm9i/ration 9 ! prior fiscal ye> & = :i* a f9al adm9i/rative ord] has be5 releas$2 7#c7 id5tification ( at lea/ #e specific cosmetic +r$i5ts & non-functional con/itu5ts t w be review$ by ! ,food & ,drug ,adm9i/ration 9 ! next fiscal ye>2 7#d7 ! numb] ( facilities inspect$ & m&atory recalls t transpir$ dur+ t fiscal ye>2 7#e7 ! numb] ( s]i\s adv]se ev5t reports receiv$ by ! ,food & ,drug ,adm9i/ration dur+ t fiscal ye>2 & 7#f7 any tr5ds id5tifi$ by ! ,food & ,drug ,adm9i/ration ab\t adv]se ev5t reports relat$ to specific cosmetic +r$i5ts or non-functional con/itu5ts4 7b7 ,public availability ,! ,food & ,drug ,adm9i/ration %all make ! reports requir$ "u subsection 7a7 available to ! public on ! ,int]net website ( ! ,food & ,drug ,adm9i/ration on ! date ( submission ( su* reports to ,congress4 7c7 ,public input on safety review ,^u release ( ! report describ$ 9 subsection 7a71 ! ,food & ,drug ,adm9i/ration %all provide ! public ) an opportunity to provide fe$back1 at any "t dur+ ! ye>1 on ! id5tification ( +r$i5ts "u subsection 7a77#c7 by-- 7#a7 provid+ an electronic portal1 ^u release ( ! report1 enabl+ ! public to-- 7,a7 comm5t on ! cosmetic +r$i5ts or non-functional con/itu5ts "u review = ! curr5t ye>2 7,b7 recomm5d additional cosmetic +r$i5ts & non-functional con/itu5ts to be consid]$ = review = safety 9 future ye>s2 & 7,c7 comm5t on ! priorities = ! specific cosmetic +r$i5ts & non-functional con/itu5ts t ! ,food & ,drug ,adm9i/ration anticipates w be review$ 9 ! next fiscal ye>2 7#b7 ann\nc+ on ! ,int]net website ( ! ,food & ,drug ,adm9i/ration1 )9 ! fir/ #cj days ( ! new fiscal ye>1 any am5dm5ts to ! li/ ( cosmetic +r$i5ts & non-functional con/itu5ts submitt$ pursuant to subsection 7a77#c7 bas$ on public input1 pursuant to p>agraph 7#a72 & 7#c7 toge!r ) ! f9al ann\ncem5t ( at lea/ #e specific cosmetic +r$i5ts & non-functional con/itu5ts t w be review$ 9 ! com+ ye> "u section #fjg1 provid+ a comm5t p]iod = fur!r public input1 pursuant to section #fjg7;a77#b74 4 #aaa4 ,small bus9esses ,*apt] ,,vi ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cfa et seq471 z am5d$ by section #aaj1 is fur!r am5d$ by add+ at ! end ! foll[+3 #fag4 ,small bus9esses ,! ,commission]1 9 coord9ation ) ! ,adm9i/rator ( ! ,small ,bus9ess ,adm9i/ration1 %all provide te*nical assi/ance1 su* z guidance & exp]tise1 to small bus9esses reg>d+ compliance ) ! ,p]sonal ,c>e ,products ,safety ,act1 includ+ ! am5dm5ts made by su* ,act4 4 #aab4 ,applicability ) respect to c]ta9 cosmetics ,*apt] ,,vi ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cfa et seq471 z am5d$ by section #aaa1 is fur!r am5d$ by add+ at ! end ! foll[+3 #fah4 ,applicability ) respect to c]ta9 cosmetics ,9 ! case ( a cosmetic product or a facility t is subject to ! requirem5ts "u ?is *apt] & *apt] ,v1 if any requirem5t "u *apt] ,v ) respect to su* cosmetic or facility is sub/antially simil> to a requirem5t "u ?is *apt]1 ! cosmetic product or facility %all be deem$ to be 9 compliance ) ! applicable requirem5t "u ?is *apt] if su* product or facility is 9 compliance ) su* sub/antially simil> requirem5t "u *apt] ,v1 provid$ t ! product or facility has n obta9$ a waiv] f ! requirem5t "u *apt] ,v4 ,9 ! case ( a cosmetic product or facility t is subject to1 & 9 compliance )1 a fee "u sub*apt] ,c ( *apt] ,,vii1 o!r ?an a fee "u "p #aj ( su* sub*apt]1 any fee "u su* "p #aj %all be waiv$ ) respect to su* cosmetic product or facility 7) respect to cosmetic products74 4 #aac4 ,en=cem5t 7a7 ,prohibit$ acts ,section #cja ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cca7 is am5d$-- 7#a7 9 p>agraph 7e7-- 7,a7 by /rik+ #ejd1 #efd1 & ins]t+ #ejd1 #efd1 #fji1 #faj12 & 7,b7 by /rik+ #eai1 #efd1 & ins]t+ #eai1 #efd1 #fji12 7#b7 9 p>agraph 7j71 by ins]t+ #fjf1 #fjg1 #fjh1 be=e #gjd2 7#c7 9 p>agraph 7ii7-- 7,a7 by /rik+ #gfj or #gfa7 or & ins]t+ #fjd1 #gfj1 or #gfa7 or2 & 7,b7 by /rik+ #gfa7 submitt$ & ins]t+ #gfa or z describ$ 9 section #fji7 submitt$2 7#d7 9 p>agraph 7xx7 by ins]t+ or #faa aft] #dbc2 & 7#e7 by add+ at ! end ! foll[+3 7fff7 ,! failure to regi/] 9 accordance ) section #fje1 ! failure to provide any in=mation requir$ by section #fje1 or ! failure to update ! in=mation requir$ by section #fje1 z requir$4 4 7b7 ,adult]ation ,section #fja ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cfa7 is am5d$ by add+ at ! end ! foll[+3 7f7 ,if ! me?ods us$ 91 or ! facilities or controls us$ =1 its manufacture1 process+1 pack+1 or hold+ d n con=m to curr5t good manufactur+ practice1 z prescrib$ by ! ,food & ,drug ,adm9i/ration 9 accordance ) section #fjh4 7g7 ,if x conta9s1 aft] ! date prescrib$ "u section #fjg7;e71 an +r$i5t t ! ,food & ,drug ,adm9i/ration has det]m9$ "u section #fjg7;d77#d7 to be n safe1 or n safe "u ! conditions ( use recomm5d$ or sugge/$ 9 ! label or a non-functional con/itu5t t ! ,food & ,drug ,adm9i/ration has det]m9$ "u section #fjg7;d77#d7 to be n safe or n safe 9 ! am\nt pres5t 9 ! cosmetic4 7h7 ,if x is a cosmetic product = :i* assurances reg>d+ safety sub/antiation h n be5 suppli$ "u section #fje7;e77#b77;,a77xii74 4 7c7 ,misbr&+ ,section #fjb ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cfb7 is am5d$-- 7#a7 9 p>agraph 7b7-- 7,a7 by /rik+ & 7#b7 & ins]t+ 7#b72 & 7,b7 by ins]t+ 2 & 7#c7 a dome/ic address or a dome/ic telephone numb]1 & x is enc\rag$ t ! label include bo? a dome/ic address & a dome/ic telephone numb]1 ?r\gh :i* ! responsible p]son may receive a report ( an adv]se ev5t associat$ ) ! use ( su* cosmetic product aft] num]ical c\nt2 & 7#b7 by add+ at ! end ! foll[+3 7g7 ,if x has be5 manufactur$ or process$ 9 any factory1 w>eh\se1 or e/abli%m5t & ! responsible p]son1 op]ator1 or ag5t ( su* factory1 w>eh\se1 or e/abli%m5t delays1 d5ies1 or limits an inspection1 or refuses to p]mit entry or inspection4 7h7 ,if its label+ does n con=m ) a requirem5t "u section #fab4 4 7d7 ,guidance ,n lat] ?an #a ye> aft] ! date ( enactm5t ( ?is ,act1 ! ,food & ,drug ,adm9i/ration %all issue guidance t def9es ! circum/ances t w\ld con/itute delay+1 d5y+1 or limit+ inspection1 or refus+ to p]mit entry or inspection1 = purposes ( section #fjb7;g7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act1 z add$ by subsection 7c77#b74 7e7 ,imports ,section #hja7;a7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cha7;a77 is am5d$-- 7#a7 by /rik+ section #gfj or #gfa ! fir/1 ?ird1 & f\r? place su* t]m appe>s & ins]t+ section #fji1 #gfj1 or #gfa2 & 7#b7 by /rik+ #gfj or #gfa7 & ins]t+ #fjd1 #gfj1 or #gfa74 7f7 ,factory inspection ,section #gjd7;a77#a7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cgd7;a77#a77 is am5d$ by ins]t+ aft] ! ?ird s5t5ce ! foll[+3 ,9 ! case ( any p]son :o manufactures1 processes1 di/ributes1 or imports a cosmetic product1 or di/ributes a cosmetic product & affixes its "n on ! cosmetic label1 ! inspection %all ext5d to all records & o!r in=mation describ$ 9 section #faj 7reg>d+ inspection ( cosmetic records71 :5 ! /&>d = records inspections "u p>agraph 7#a7 or 7#b7 ( subsection 7a7 ( su* section applies1 subject to ! limitations "u subsections 7d7 & 7e7 ( su* section44 #aad4 ,consum] in=mation ,! ,food & ,drug ,adm9i/ration %all po/ on its ,int]net website in=mation = consum]s reg>d+-- 7#a7 f9al ord]s reg>d+ ! safety ( a cosmetic +r$i5t or non-functional con/itu5t "u section #fjg7;d77#c7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act2 7#b7 cosmetic product recalls 7includ+ volunt>y & m&atory recalls72 & 7#c7 id5tifi$ c\nt]feit cosmetic products4 ,,ii ,fees ,relat$ to ,cosmetic ,safety #bja4 ,f9d+s ,congress f9ds t ! fees au?oriz$ by ! am5dm5ts made by ?is title w be d$icat$ to cosmetic safety activities1 z set =? 9 ! goals id5tifi$ = purposes ( "p #aj ( sub*apt] ,c ( *apt] ,,vii ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act1 9 ! lett]s f ! ,secret>y ( ,heal? & ,human ,s]vices to ! ,*airman ( ! ,committee on ,heal?1 ,education1 ,labor1 & ,p5sions ( ! ,s5ate & ! ,*airman ( ! ,committee on ,en]gy & ,comm]ce ( ! ,h\se ( ,repres5tatives1 z set =? 9 ! ,congressional ,record4 #bjb4 ,au?ority to assess & use cosmetic safety fees ,sub*apt] ,c ( *apt] ,,vii ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;f et seq47 is am5d$ by add+ at ! end ! foll[+3 #aj ,fees ,relat+ to ,cosmetics #gdd,l4 ,regi/ration fee 7a7 ,assessm5t & collection 7#a7 ,9 g5]al ,beg9n+ 9 fiscal ye> #bjbj1 ! ,food & ,drug ,adm9i/ration %all assess & collect an annual fee f e responsible p]son 7ref]r$ to 9 ?is section z a regi/rant7 :o owns or op]ates any facility 7z def9$ 9 section #fjd7c77 engag$ 9 manufactur+ or process+1 or ^: "n & address appe> on ! label ( a cosmetic product di/ribut$ 9 ! ,unit$ ,/ates1 except t ?is subsection %all n apply to contract manufactur]s if a responsible p]son has already paid ! appropriate fee ) respect to ! cosmetic product1 to ensure no d\ble fees are paid4 7#b7 ,payable date ,a fee "u ?is section %all be payable dur+ ! p]iod ( initial regi/ration & on ! date ( regi/ration ea* ye> !reaft] z prescrib$ 9 section #fje7;a77#a74 7b7 ,def9itions ,9 ?is section3 7#a7 ,adju/m5t factor ,! t]m adju/m5t factor applicable to a fiscal ye> means ! ,consum] ,price ,index = all urban consum]s 7all items2 ,unit$ ,/ates city av]age7 = ,octob] ( ! prec$+ fiscal ye> divid$ by su* index = ,octob] #bjai4 7#b7 ,affiliate ,! t]m affiliate means any bus9ess entity t has a relation%ip ) a second bus9ess entity if1 directly or indirectly-- 7,a7 "o bus9ess entity controls1 or has p[] to control1 ! o!r bus9ess entity2 or 7,b7 a ?ird p>ty controls1 or has ! p[] to control1 bo? ( ! bus9ess entities4 7#c7 ,cosmetic product ,! t]m cosmetic product has ! mean+ giv5 su* t]m 9 section #fjd7b74 7#d7 ,cosmetic safety activities ,! t]m cosmetic safety activities-- 7,a7 means activities relat$ to compliance by regi/rants "u section #fje ) ! requirem5ts ( ?is ,act ) respect to cosmetics1 includ+-- 7i7 adm9i/rative activities1 su* z in=mation te*nology support1 human res\rces1 f9ancial managem5t1 ! adm9i/ration & ma9t5ance ( ! cosmetic regi/ration sy/em & ! cosmetic +r$i5t /atem5t sy/em "u section #fje1 & fee assessm5t & collection "u ?is section2 & 7ii7 implem5tation & en=cem5t activities1 su* z ! e/abli%m5t ( good manufactur+ practices1 ! review ( adv]se ev5t reports1 inspection plann+ & inspections1 & use ( en=cem5t tools2 & 7,b7 includes activities relat$ to implem5tation ( section #fjg1 reg>d+ ! review ( cosmetic +r$i5ts & non-functional con/itu5ts4 7#e7 ,gross annual sales ,! t]m gross annual sales means ! av]age ,unit$ ,/ates gross annual sales = ! previ\s #c-ye> p]iod ( cosmetics = a regi/rant1 includ+ ! sales ( all ( its affiliates1 z report$ 9 ! regi/ration "u section #fje4 7c7 ,fee sett+ & am\nts 7#a7 ,9 g5]al ,subject to subsection 7d71 ! ,food & ,drug ,adm9i/ration %all e/abli% ! fees to be collect$ "u ?is section = ea* fiscal ye> aft] fiscal ye> #bjbj1 bas$ on ! me?odology describ$ 9 p>agraph 7#c71 & %all publi% su* fees 9 a ,f$]al ,regi/] notice n lat] ?an #fj days be=e ! beg9n+ ( ea* su* fiscal ye>4 7#b7 ,fee exemption ,any regi/rant ^: gross annual sales ( cosmetic products 9 ! #c-ye> p]iod imm$iately prec$+ ! fiscal ye> = :i* ! annual fee w be paid 0 n m ?an #aj1jjj1jjj1 %all be exempt f regi/ration fees "u ?is section = t fiscal ye>4 7#c7 ,annual fee sett+ ,= fiscal ye>s #bjbj ?r\gh #bjbe1 to g5]ate a total e/imat$ annual rev5ue am\nt ( #bj1fjj1jjj1 ! am\nt ( ! regi/ration fee "u subsection 7a7 %all be z foll[s3 7,a7 ,ti] ,i-,a ,= a regi/rant t has gross annual sales ( #e1jjj1jjj1jjj or m 9 #bjah1 #a1cej1jjj4 7,b7 ,ti] ,i-,b ,= a regi/rant t has gross annual sales ( at lea/ #d1jjj1jjj1jjj p] annum b less ?an #e1jjj1jjj1jjj 9 #bjah1 #hej1jjj4 7,c7 ,ti] ,,ii-,a ,= a regi/rant t has gross annual sales ( at lea/ #c1jjj1jjj1jjj p] annum b less ?an #d1jjj1jjj1jjj 9 #bjah1 #gcj1jjj4 7,d7 ,ti] ,,ii-,b ,= a regi/rant t has gross annual sales ( at lea/ #b1jjj1jjj1jjj p] annum b less ?an #c1jjj1jjj1jjj 9 #bjah1 #faj1jjj4 7,e7 ,ti] ,,iii-,a ,= a regi/rant t has gross annual sales ( at lea/ #a1jjj1jjj1jjj p] annum b less ?an #b1jjj1jjj1jjj 9 #bjah1 #ejj1jjj4 7,f7 ,ti] ,,iii-,b ,= a regi/rant t has gross annual sales ( at lea/ #ejj1jjj1jjj p] annum b less ?an #a1jjj1jjj1jjj 9 #bjah1 #cie1jjj4 7,g7 ,ti] ,,iv-,a ,= a regi/rant t has gross annual sales ( at lea/ #bjj1jjj1jjj p] annum b less ?an #ejj1jjj1jjj 9 #bjah1 #cbe1jjj4 7,h7 ,ti] ,,iv-,b ,= a regi/rant t has gross annual sales ( at lea/ #ajj1jjj1jjj p] annum b less ?an #bjj1jjj1jjj 9 #bjah1 #bge1jjj4 7,i7 ,ti] ,v-,a ,= a regi/rant t has gross annual sales ( at lea/ #hj1jjj1jjj p] annum b less ?an #ajj1jjj1jjj 9 #bjah1 #ahe1jjj4 7,j7 ,ti] ,v-,b ,= a regi/rant t has gross annual sales ( at lea/ #fj1jjj1jjj p] annum b less ?an #hj1jjj1jjj 9 #bjah1 #ie1jjj4 7,k7 ,ti] ,,vi-,a ,= a regi/rant t has gross annual sales ( at lea/ #dj1jjj1jjj p] annum b less ?an #fj1jjj1jjj 9 #bjah1 #ae1jjj4 7,l7 ,ti] ,,iv-,b ,= a regi/rant t has gross annual sales ( at lea/ #bj1jjj1jjj p] annum b less ?an #dj1jjj1jjj 9 #bjah1 #ab1jjj4 7,m7 ,ti] ,,vii-,a ,= a regi/rant t has gross annual sales ( at lea/ #aj1jjj1jjj p] annum b less ?an #bj1jjj1jjj 9 #bjah1 #ejj4 7d7 ,adju/m5ts 7#a7 ,inflation adju/m5t 7,a7 ,9 g5]al ,= fiscal ye> #bjba & ea* subsequ5t fiscal ye>1 ! rev5ues & fee am\nts "u subsection 7c77#c7 %all be adju/$ by ! ,food & ,drug ,adm9i/ration 9 ! annual ,f$]al ,regi/] notice e/abli%+ fees 9 subsection 7c77#a71 by an am\nt equal to ! sum (-- 7i7 "o2 7ii7 ! av]age annual p]c5t *ange 9 ! co/1 p] full-"t equival5t position ( ! ,food & ,drug ,adm9i/ration1 ( all p]sonnel comp5sation & b5efits paid ) respect to su* positions = ! fir/ #c ( ! prec$+ #d fiscal ye>s = :i* data are available1 multipli$ by ! av]age proportion ( p]sonnel comp5sation & b5efits co/s to total ,food & ,drug ,adm9i/ration co/s = ! fir/ #c ye>s ( ! prec$+ #d fiscal ye>s = :i* data are available2 & 7iii7 ! av]age annual p]c5t *ange t occurr$ 9 ! ,consum] ,price ,index = urban consum]s 7,wa%+ton-,baltimore1 ,,dc#f ,,md-,,va-,,wv2 n seasonally adju/$2 all items less food & en]gy2 annual index7 = ! fir/ #c ye>s ( ! prec$+ #d ye>s = :i* data are available multipli$ by ! av]age proportion ( all co/s o!r ?an p]sonnel comp5sation & b5efits co/s to total ,food & ,drug ,adm9i/ration co/s = ! fir/ #c ye>s ( ! prec$+ #d fiscal ye>s = :i* data are available4 7,b7 ,comp\nd$ basis ,! adju/m5t made ea* fiscal ye> "u ?is subsection %all be add$ on a comp\nd$ basis to ! sum ( all adju/m5ts made ea* fiscal ye> aft] fiscal ye> #bjbj "u ?is subsection4 7#b7 ,f9al ye> adju/m5t ,= fiscal ye> #bjbe1 ! ,food & ,drug ,adm9i/ration may1 9 addition to adju/m5ts "u p>agraph 7#a71 fur!r increase ! fee rev5ues & fees e/abli%$ 9 subsection 7c7 if su* an adju/m5t is necess>y to provide = n m ?an #c mon?s ( op]at+ res]ves ( c>ryov] fees = cosmetic safety activities = ! fir/ #c mon?s ( fiscal ye> #bjbf4 ,if su* an adju/m5t is necess>y1 ! rationale = ! increase1 %all be conta9$ 9 ! annual ,f$]al ,regi/] notice e/abli%+ fees1 9 subsection 7c77#a71 = fiscal ye> #bjbe4 ,if ! ,food & ,drug ,adm9i/ration has c>ryov] balances = su* activities 9 excess ( #c mon?s ( su* op]at+ res]ves1 ! adju/m5t "u ?is subp>agraph %all n be made4 7#c7 ,workload adju/m5t 7,a7 ,9 g5]al ,= fiscal ye> #bjba & ea* subsequ5t fiscal ye>1 aft] fee rev5ues e/abli%$ 9 subsection 7c77#c7 are adju/$ = a fiscal ye> = inflation 9 accordance ) p>agraph 7#a71 ! fee rev5ues %all be adju/$ fur!r = ea* fiscal ye> to reflect *anges 9 ! workload ( ! ,food & ,drug ,adm9i/ration = actual *anges 9 workload volume due to ! process ( review+ cosmetic +r$i5ts or non-functional con/itu5ts n li/$ "u section #fjg7;b74 7,b7 ,det]m9ation ( adju/m5t ,! adju/m5t %all be det]m9$ by ! ,food & ,drug ,adm9i/ration bas$ on ! workload 9 ! mo/ rec5t #a-ye> p]iod = :i* workload data is available4 ,! ,food & ,drug ,adm9i/ration %all publi% 9 ! ,f$]al ,regi/] ! fee rev5ues & fees result+ f ! adju/m5t & ! support+ me?odologies4 7,c7 ,m9imum rev5ues ,! adju/m5t %all n result 9 fee rev5ues = a fiscal ye> t are less ?an ! sum ( ! am\nt "u subsection 7c77#c71 z adju/$ = inflation "u subp>agraph 7#a74 7e7 ,limitations 7#a7 ,9 g5]al ,) respect to ! am\nt t1 "u ! sal>ies & exp5ses acc\nt ( ! ,food & ,drug ,adm9i/ration1 is appropriat$ = a fiscal ye> = ! cosmetics program 9 ! ,c5t] = ,food ,safety & ,appli$ ,nutrition & relat$ field activities1 fees may n be assess$ "u subsection 7a7 = ! fiscal ye> unless ! am\nt s appropriat$ = ! fiscal ye> 7exclud+ ! am\nt ( fees appropriat$ = ! fiscal ye>71 is equal to or great] ?an t assess$ = fiscal ye> #bjai1 multipli$ by ! adju/m5t factor applicable to ! fiscal ye> involv$4 7#b7 ,au?ority ,if ! ,food & ,drug ,adm9i/ration does n assess fees "u subsection 7a7 dur+ any portion ( a fiscal ye> because ( p>agraph 7#a7 & if at a lat] date 9 su* fiscal ye> ! ,food & ,drug ,adm9i/ration may assess su* fees1 ! ,food & ,drug ,adm9i/ration may assess & collect su* fees1 )\t any modification 9 ! rate1 = regi/ration "u section #fje at any "t 9 su* fiscal ye>4 7f7 ,cr$it+ & availability ( fees 7#a7 ,9 g5]al ,fees au?oriz$ "u subsection 7a7 %all be collect$ & available = obligation only to ! ext5t & 9 ! am\nt provid$ 9 advance 9 appropriations ,acts4 ,su* fees are au?oriz$ to rema9 available until exp5d$4 ,su* sums z may be necess>y may be transf]r$ f ! ,food & ,drug ,adm9i/ration sal>ies & exp5ses appropriation acc\nt )\t fiscal ye> limitation to su* appropriation acc\nt = sal>ies & exp5ses ) su* fiscal ye> limitation4 ,! sums transf]r$ %all be available solely = cosmetic safety activities4 7#b7 ,collections & appropriations acts 7,a7 ,9 g5]al ,subject to subp>agraphs 7,c7 & 7,d71 ! fees au?oriz$ by ?is section %all be collect$ & available 9 ea* fiscal ye> 9 an am\nt n to exce$ ! am\nt specifi$ 9 appropriation ,acts1 or o!rwise made available = obligation = su* fiscal ye>4 7,b7 ,use ( fees & limitation ,! fees au?oriz$ by ?is section %all be collect$ & available only to defray ! co/s ( cosmetic safety activities4 7,c7 ,fee collections dur+ fir/ program ye> ,until ! date ( enactm5t ( an ,act mak+ appropriations ?r\gh ,septemb] #cj1 #bjbj1 = ! sal>ies & exp5ses acc\nt ( ! ,food & ,drug ,adm9i/ration1 fees au?oriz$ by ?is section = fiscal ye> #bjbj may be collect$ & %all be cr$it$ to su* acc\nt to rema9 available until exp5d$4 ,fees collect$ "u ?is subp>agraph %all be consid]$ discretion>y = purposes ( ! ,balanc$ ,budget & ,em]g5cy ,deficit ,control ,act ( #aihe4 7,d7 ,reimbursem5t ( />t-up am\nts ,any am\nts allocat$ to e/abli% programs "u section #fje1 prior to collection ( fees1 may be reimburs$ ?r\gh any appropriat$ fees collect$ "u ?is section1 9 su* mann] z ! ,food & ,drug ,adm9i/ration det]m9es appropriate4 ,any am\nts reimburs$ "u ?is subp>agraph %all be available = ! programs & activities = :i* funds allocat$ to e/abli% ! programs 7 available1 prior to su* allocation1 until ! end ( ! fiscal ye> 9 :i* ! reimbursem5t occurs1 not)/&+ any o!rwise applicable limits on am\nts = su* program or activities = a fiscal ye>4 7#c7 ,au?orization ( appropriations ,= ea* ( fiscal ye>s #bjbj ?r\gh #bjbf1 !re are au?oriz$ to be appropriat$ = fees "u ?is section #bj1fjj1jjj1 z adju/$ by subsection 7d74 7#d7 ,(fset ( ov]collections2 recov]y ( collection %ortfalls 7,a7 ,(fset ( ov]collections ,if ! sum ( ! cumulative am\nt ( fees collect$ "u ?is section = ! fiscal ye>s #bjbj ?r\gh #bjbd exce$s ! cumulative am\nt appropriat$ pursuant to p>agraph 7#c7 = fiscal ye>s #bjbj ?r\gh #bjbe1 ! excess am\nt %all be cr$it$ to ! appropriation acc\nt ( ! ,food & ,drug ,adm9i/ration z provid$ 9 p>agraph 7#a71 & %all be subtract$ f ! am\nt ( fees t w\ld o!rwise be au?oriz$ to be collect$ "u ?is section pursuant to appropriation ,acts = fiscal ye> #bjbf4 7,b7 ,recov]y ( collection %ortfalls 7i7 #bjbb ,= fiscal ye> #bjbb1 ! am\nt ( fees o!rwise au?oriz$ to be collect$ "u ?is section %all be increas$ by ! am\nt1 if any1 by :i* ! am\nt collect$ "u ?is section & appropriat$ = fiscal ye> #bjbj falls bel[ ! am\nt ( fees au?oriz$ = fiscal ye> #bjbj "u p>agraph 7#c74 7ii7 #bjbc ,= fiscal ye> #bjbc1 ! am\nt ( fees o!rwise au?oriz$ to be collect$ "u ?is section %all be increas$ by ! am\nt1 if any1 by :i* ! am\nt collect$ "u ?is section & appropriat$ = fiscal ye> #bba falls bel[ ! am\nt ( fees au?oriz$ = fiscal ye> #bjba "u p>agraph 7#c74 7iii7 #bjbd ,= fiscal ye> #bjbd1 ! am\nt ( fees o!rwise au?oriz$ to be collect$ "u ?is section %all be increas$ by ! am\nt1 if any1 by :i* ! am\nt collect$ "u ?is section & appropriat$ = fiscal ye> #bjbb falls bel[ ! am\nt ( fees au?oriz$ = fiscal ye> #bjbb "u p>agraph 7#c74 7iv7 #bjbe ,= fiscal ye> #bjbe1 ! am\nt ( fees o!rwise au?oriz$ to be collect$ "u ?is section %all be increas$ by ! am\nt1 if any1 by :i* ! am\nt collect$ "u ?is section & appropriat$ = fiscal ye> #bjbc falls bel[ ! am\nt ( fees au?oriz$ = fiscal ye> #bjbc "u p>agraph 7#c74 7v7 #bjbf ,= fiscal ye> #bjbf1 ! am\nt ( fees o!rwise au?oriz$ to be collect$ "u ?is section %all be increas$ 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#c74 7g7 ,effect ( failure ,to pay fees ,! ,food & ,drug ,adm9i/ration %all n consid] a regi/ration submitt$ to be complete until su* fee "u subsection 7a7 is paid4 ,until ! fee is paid1 ! regi/ration is incomplete & ! regi/rant is deem$ to h fail$ to regi/] 9 accordance ) section #fje4 7h7 ,false /atem5ts ,any /atem5t or repres5tation made to ! ,food & ,drug ,adm9i/ration %all be subject to section #ajja ( title #ah1 ,unit$ ,/ates ,code4 7i7 ,collection ( unpaid fees ,9 any case :]e ! ,food & ,drug ,adm9i/ration does n receive paym5t ( a fee assess$ "u subsection 7a71 su* fee %all be treat$ z a claim ( ! ,unit$ ,/ates ,gov]nm5t subject to sub*apt] ,,ii ( *apt] #cg ( title #ca1 ,unit$ ,/ates ,code4 7j7 ,con/ruction ,?is section may n be con/ru$ to require t ! numb] ( full-"t equival5t positions 9 ! ,dep>tm5t ( ,heal? & ,human ,s]vices1 = (fic]s1 employees1 & advisory committees n engag$ 9 cosmetic activities1 be r$uc$ to (fset ! numb] ( (fic]s1 employees1 & advisory committees s engag$4 7k7 ,records ,ea* facility %all reta9 all records necess>y to demon/rate ! facility's gross annual sales = at lea/ #b fiscal ye>s aft] su* in=mation is report$ 9 ! facility's regi/ration4 ,su* records %all be made available to ! ,food & ,drug ,adm9i/ration = review & duplication ^u reque/ ( ! ,food & ,drug ,adm9i/ration4 4 #bjc4 ,direct hir+ au?ority to support activities relat$ to cosmetics ,"p #aj ( sub*apt] ,c ( *apt] ,,vii ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act1 z add$ by section #bjb1 is am5d$ by ins]t+ aft] section #gdd,l ! foll[+3 #gdd,m4 ,direct hir+ au?ority to support activities relat$ to cosmetics 7a7 ,9 g5]al ,! ,food & ,drug ,adm9i/ration %all h direct hir+ au?ority ) respect to ! appo9tm5t ( employees into ! competitive s]vice or ! except$ s]vice to adm9i/] ! am5dm5ts made by title ,i ( ! ,p]sonal ,c>e ,products ,safety ,act4 7b7 ,sunset ,! au?ority "u subsection 7a7 %all t]m9ate on ! date t is #c ye>s aft] ! date ( enactm5t ( su* title4 4