#aaf? ,,congress #a/ ,session ,s4 #bgdj ,,an ,,act ,to am5d ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act to cl>ify ! regulatory framework ) respect to c]ta9 nonprescription drugs t are m>ket$ )\t an approv$ new drug application1 & = o!r purposes4 #a4 ,%ort title2 table ( cont5ts 7a7 ,%ort title ,?is ,act may be cit$ z ! ,ov]-!-,c\nt] ,monograph ,safety1 ,innovation1 & ,re=m ,act ( #bjai4 7b7 ,table ( cont5ts ,! table ( cont5ts = ?is ,act is z foll[s3 ,sec4 #a4 ,%ort title2 table ( cont5ts4,,title ,i--,,otc ,drug ,review,sec4 #aja4 ,regulation ( c]ta9 nonprescription drugs t are m>ket$ )\t an approv$ drug application4,sec4 #ajb4 ,misbr&+4,sec4 #ajc4 ,drugs exclud$ f ! ov]-!-c\nt] drug review4,sec4 #ajd4 ,treatm5t ( ,sunscre5 ,innovation ,act4,sec4 #aje4 ,annual update to ,congress on appropriate p$iatric indication = c]ta9 ,,otc c\gh & cold drugs4,sec4 #ajf4 ,te*nical corrections4,,title ,,ii--,us] ,fees,sec4 #bja4 ,%ort title2 f9d+4,sec4 #bjb4 ,fees relat+ to ov]-!-c\nt] drugs4 ,i ,,otc ,drug ,review #aja4 ,regulation ( c]ta9 nonprescription drugs t are m>ket$ )\t an approv$ drug application 7a7 ,9 g5]al ,*apt] ,v ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act is am5d$ by ins]t+ aft] section #eje;,f ( su* ,act 7#ba ,u4,s4,c4 #cee;g7 ! foll[+3 #eje;,g4 ,regulation ( c]ta9 nonprescription drugs t are m>ket$ )\t an approv$ drug application 7a7 ,nonprescription drugs m>ket$ )\t an approv$ application ,nonprescription drugs m>ket$ )\t an approv$ drug application "u section #eje1 z ( ! date ( ! enactm5t ( ?is section1 %all be treat$ 9 accordance ) ?is subsection4 7#a7 ,drugs subject to a f9al monograph2 category ,i drugs subject to a t5tative f9al monograph ,a drug is deem$ to be g5]ally recogniz$ z safe & effective "u section #bja7p77#a71 n a new drug "u section #bja7p71 & n subject to section #ejc7;b77#a71 if-- 7,a7 ! drug is-- 7i7 9 con=mity ) ! requirem5ts = nonprescription use ( a f9al monograph issu$ "u "p #ccj ( title #ba1 ,code ( ,f$]al ,regulations 7except z provid$ 9 p>agraph 7#b771 ! g5]al requirem5ts = nonprescription drugs1 & conditions or requirem5ts "u subsections 7b71 7c71 & 7k72 & 7ii7 except z p]mitt$ by an ord] issu$ "u subsection 7b7 or1 9 ! case ( a m9or *ange 9 ! drug1 9 con=mity ) an ord] issu$ "u subsection 7c71 9 a dosage =m t1 imm$iately prior to ! date ( ! enactm5t ( ?is section1 has be5 us$ to a mat]ial ext5t & = a mat]ial "t "u section #bja7p77#b72 or 7,b7 ! drug is-- 7i7 classifi$ 9 category ,i = safety & effectiv5ess "u a t5tative f9al monograph t is ! mo/ rec5tly applicable proposal or det]m9ation issu$ "u "p #ccj ( title #ba1 ,code ( ,f$]al ,regulations2 7ii7 9 con=mity ) ! propos$ requirem5ts = nonprescription use ( su* t5tative f9al monograph1 any applicable subsequ5t det]m9ation by ! ,secret>y1 ! g5]al requirem5ts = nonprescription drugs1 & conditions or requirem5ts "u subsections 7b71 7c71 & 7k72 & 7iii7 except z p]mitt$ by an ord] issu$ "u subsection 7b7 or1 9 ! case ( a m9or *ange 9 ! drug1 9 con=mity ) an ord] issu$ "u subsection 7c71 9 a dosage =m t1 imm$iately prior to ! date ( ! enactm5t ( ?is section1 has be5 us$ to a mat]ial ext5t & = a mat]ial "t "u section #bja7p77#b74 7#b7 ,treatm5t ( sunscre5 drugs ,) respect to sunscre5 drugs subject to ?is section1 ! applicable requirem5ts 9 t]ms ( con=mity ) a f9al monograph1 = purposes ( p>agraph 7#a77;,a77i71 %all be ! requirem5ts specifi$ 9 "p #ceb ( title #ba1 ,code ( ,f$]al ,regulations1 z publi%$ on ,may #ba1 #aiii1 beg9n+ on page #bgfhg ( volume #fd ( ! ,f$]al ,regi/]1 except t ! applicable requirem5ts gov]n+ effectiv5ess & label+ %all be ^? specifi$ 9 section #bja4cbg ( title #ba1 ,code ( ,f$]al ,regulations4 7#c7 ,category ,,iii drugs subject to a t5tative f9al monograph2 category ,i drugs subject to propos$ monograph or advance notice ( propos$ rulemak+ ,a drug t is n describ$ 9 p>agraph 7#a71 7#b71 or 7#d7 is n requir$ to be ! subject ( an application approv$ "u section #eje1 & is n subject to section #ejc7;b77#a71 if-- 7,a7 ! drug is-- 7i7 classifi$ 9 category ,,iii = safety or effectiv5ess 9 ! preamble ( a propos$ rule e/abli%+ a t5tative f9al monograph t is ! mo/ rec5tly applicable proposal or det]m9ation = su* drug issu$ "u "p #ccj ( title #ba1 ,code ( ,f$]al ,regulations2 7ii7 9 con=mity )-- 7,i7 ! conditions ( use1 includ+ indication & dosage /r5g?1 if any1 describ$ = su* category ,,iii drug 9 su* preamble or 9 an applicable subsequ5t propos$ rule2 7,,ii7 ! propos$ requirem5ts = drugs classifi$ 9 su* t5tative f9al monograph 9 category ,i 9 ! mo/ rec5tly propos$ rule e/abli%+ requirem5ts relat$ to su* t5tative f9al monograph & 9 any f9al rule e/abli%+ requirem5ts t are applicable to ! drug2 & 7,,iii7 ! g5]al requirem5ts = nonprescription drugs & conditions or requirem5ts "u subsection 7b7 or 7k72 & 7iii7 9 a dosage =m t1 imm$iately prior to ! date ( ! enactm5t ( ?is section1 _h be5 us$ to a mat]ial ext5t & = a mat]ial "t "u section #bja7p77#b72 or 7,b7 ! drug is-- 7i7 classifi$ 9 category ,i = safety & effectiv5ess "u a propos$ monograph or advance notice ( propos$ rulemak+ t is ! mo/ rec5tly applicable proposal or det]m9ation = su* drug issu$ "u "p #ccj ( title #ba1 ,code ( ,f$]al ,regulations2 7ii7 9 con=mity ) ! requirem5ts = nonprescription use ( su* propos$ monograph or advance notice ( propos$ rulemak+1 any applicable subsequ5t det]m9ation by ! ,secret>y1 ! g5]al requirem5ts = nonprescription drugs1 & conditions or requirem5ts "u subsection 7b7 or 7k72 & 7iii7 9 a dosage =m t1 imm$iately prior to ! date ( ! enactm5t ( ?is section1 has be5 us$ to a mat]ial ext5t & = a mat]ial "t "u section #bja7p77#b74 7#d7 ,category ,,ii drugs deem$ new drugs ,a drug t is classifi$ 9 category ,,ii = safety or effectiv5ess "u a t5tative f9al monograph or t is subject to a det]m9ation to be n g5]ally recogniz$ z safe & effective 9 a propos$ rule t is ! mo/ rec5tly applicable proposal issu$ "u "p #ccj ( title #ba1 ,code ( ,f$]al ,regulations1 %all be deem$ to be a new drug "u section #bja7p71 misbr&$ "u section #ejb7;ee71 & subject to ! requirem5t = an approv$ new drug application "u section #eje beg9n+ on ! day t is #ahj cal5d> days aft] ! date ( ! enactm5t ( ?is section1 unless1 be=e su* day1 ! ,secret>y det]m9es t x is 9 ! int]e/ ( public heal? to ext5d ! p]iod dur+ :i* ! drug may be m>ket$ )\t su* an approv$ new drug application4 7#e7 ,drugs n ,,grase deem$ new drugs ,a drug t ! ,secret>y has det]m9$ n to be g5]ally recogniz$ z safe & effective "u section #bja7p77#a7 "u a f9al det]m9ation issu$ "u "p #ccj ( title #ba1 ,code ( ,f$]al ,regulations1 %all be deem$ to be a new drug "u section #bja7p71 misbr&$ "u section #ejb7;ee71 & subject to ! requirem5t = an approv$ new drug application "u section #eje4 7#f7 ,o!r drugs deem$ new drugs ,except z provid$ 9 subsection 7m71 a drug is deem$ to be a new drug "u section #bja7p7 & misbr&$ "u section #ejb7;ee7 if ! drug-- 7,a7 is n subject to section #ejc7;b77#a72 & 7,b7 is n describ$ 9 p>agraph 7#a71 7#b71 7#c71 7#d71 or 7#e71 or subsection 7b77#a77;,b74 7b7 ,adm9i/rative ord]s 7#a7 ,9 g5]al 7,a7 ,det]m9ation ,! ,secret>y may1 on ! initiative ( ! ,secret>y or at ! reque/ ( "o or m reque/ors1 issue an adm9i/rative ord] det]m9+ :e!r !re are conditions "u :i* a specific drug1 a class ( drugs1 or a comb9ation ( drugs1 is det]m9$ to be-- 7i7 n subject to section #ejc7;b77#a72 & 7ii7 g5]ally recogniz$ z safe & effective "u section #bja7p77#a74 7,b7 ,effect ,a drug or comb9ation ( drugs %all be deem$ to n require approval "u section #eje if su* drug or comb9ation ( drugs-- 7i7 is det]m9$ by ! ,secret>y to meet ! conditions specifi$ 9 clauses 7i7 & 7ii7 ( subp>agraph 7,a72 7ii7 is m>ket$ 9 con=mity ) an adm9i/rative ord] "u ?is subsection2 7iii7 meets ! g5]al requirem5ts = nonprescription drugs2 & 7iv7 meets ! requirem5ts "u subsections 7c7 & 7k74 7,c7 ,/&>d ,! ,secret>y %all f9d t a drug is n g5]ally recogniz$ z safe & effective "u section #bja7p77#a7 if-- 7i7 ! evid5ce %[s t ! drug is n g5]ally recogniz$ z safe & effective "u section #bja7p77#a72 or 7ii7 ! evid5ce is inadequate to %[ t ! drug is g5]ally recogniz$ z safe & effective "u section #bja7p77#a74 7#b7 ,adm9i/rative ord]s initiat$ by ! secret>y 7,a7 ,9 g5]al ,9 issu+ an adm9i/rative ord] "u p>agraph 7#a7 ^u ! ,secret>y's initiative1 ! ,secret>y %all-- 7i7 make reasonable ef=ts to notify in=mally1 n lat] ?an #b bus9ess days be=e ! issuance ( ! propos$ ord]1 ! sponsors ( drugs :o h a li/+ 9 effect "u section #eaj7;j7 = ! drugs or comb9ation ( drugs t w be subject to ! adm9i/rative ord]2 7ii7 aft] any su* reasonable ef=ts ( notification-- 7,i7 issue a propos$ adm9i/rative ord] by publi%+ x on ! website ( ! ,food & ,drug ,adm9i/ration & include 9 su* ord] ! reasons = ! issuance ( su* ord]2 & 7,,ii7 publi% a notice ( availability ( su* propos$ ord] 9 ! ,f$]al ,regi/]2 7iii7 except z provid$ 9 subp>agraph 7,b71 provide = a public comm5t p]iod ) respect to su* propos$ ord] ( n less ?an #de cal5d> days2 & 7iv7 if1 aft] completion ( ! proce$+s specifi$ 9 clauses 7i7 ?r\gh 7iii71 ! ,secret>y det]m9es t x is appropriate to issue a f9al adm9i/rative ord]-- 7,i7 issue ! f9al adm9i/rative ord]1 toge!r ) a detail$ /atem5t ( reasons1 :i* ord] %all n take effect until ! "t = reque/+ judicial review "u p>agraph 7#c77;,d77ii7 has expir$2 7,,ii7 publi% a notice ( su* f9al adm9i/rative ord] 9 ! ,f$]al ,regi/]2 7,,iii7 af=d reque/ors ( drugs t w be subject to su* ord] ! opportunity = =mal dispute resolution up to ! level ( ! ,director ( ! ,c5t] = ,drug ,evaluation & ,rese>*1 :i* initially mu/ be reque/$ )9 #de cal5d> days ( ! issuance ( ! ord]1 &1 = subsequ5t levels ( appeal1 )9 #cj cal5d> days ( ! prior decision2 & 7,,iv7 except ) respect to drugs describ$ 9 p>agraph 7#c77;,b71 ^u completion ( ! =mal dispute resolution proc$ure1 in=m ! p]sons :i* s\ght su* dispute resolution ( _! "r to reque/ a he>+4 7,b7 ,exceptions ,:5 issu+ an adm9i/rative ord] "u p>agraph 7#a7 on ! ,secret>y's initiative propos+ to det]m9e t a drug describ$ 9 subsection 7a77#c7 is n g5]ally recogniz$ z safe & effective "u section #bja7p77#a71 ! ,secret>y %all foll[ ! proc$ures 9 subp>agraph 7,a71 except t-- 7i7 ! propos$ ord] %all include notice (-- 7,i7 ! g5]al categories ( data ! ,secret>y has det]m9$ necess>y to e/abli% t ! drug is g5]ally recogniz$ z safe & effective "u section #bja7p77#a72 & 7,,ii7 ! =mat = submissions by int]e/$ p]sons2 7ii7 ! ,secret>y %all provide = a public comm5t p]iod ( no less ?an #ahj cal5d> days ) respect to su* propos$ ord]1 except :5 ! ,secret>y det]m9es1 = good cause1 t a %ort] p]iod is 9 ! int]e/ ( public heal?2 & 7iii7 any p]son :o submits data 9 su* comm5t p]iod %all include a c]tification t ! p]son has submitt$ all evid5ce creat$1 obta9$1 or receiv$ by t p]son t is bo? )9 ! categories ( data id5tifi$ 9 ! propos$ ord] & relevant to a det]m9ation z to :e!r ! drug is g5]ally recogniz$ z safe & effective "u section #bja7p77#a74 7#c7 ,he>+s2 judicial review 7,a7 ,9 g5]al ,only a p]son :o p>ticipat$ 9 ea* /age ( =mal dispute resolution "u subclause 7,,iii7 ( p>agraph 7#b77;,a77iv7 ( an adm9i/rative ord] ) respect to a drug may reque/ a he>+ conc]n+ a f9al adm9i/rative ord] issu$ "u su* p>agraph ) respect to su* drug4 ,if a he>+ is s\ght1 su* p]son mu/ submit a reque/ = a he>+1 :i* %all be bas$ solely on in=mation 9 ! adm9i/rative record1 to ! ,secret>y n lat] ?an #cj cal5d> days aft] receiv+ notice ( ! f9al decision ( ! =mal dispute resolution proc$ure4 7,b7 ,no he>+ requir$ ) respect to ord]s relat+ to c]ta9 drugs 7i7 ,9 g5]al ,! ,secret>y %all n be requir$ to provide notice & an opportunity = a he>+ pursuant to p>agraph 7#b77;,a77iv7 if ! f9al adm9i/rative ord] involv$ relates to a drug-- 7,i7 t is describ$ 9 subsection 7a77#c77;,a72 & 7,,ii7 ) respect to :i* no human or non-human data /udies relevant to ! safety or effectiv5ess ( su* drug h be5 submitt$ to ! adm9i/rative record s9ce ! issuance ( ! mo/ rec5t t5tative f9al monograph relat+ to su* drug4 7ii7 ,human data /udies & non-human data def9$ ,9 ?is subp>agraph3 7,i7 ,! t]m human data /udies means cl9ical trials ( safety or effectiv5ess 7includ+ actual use /udies71 ph>macok9etics /udies1 or bioavailability /udies4 7,,ii7 ,! t]m non-human data means data f te/+ o!r ?an ) human subjects :i* provides in=mation conc]n+ safety or effectiv5ess4 7,c7 ,he>+ proc$ures 7i7 ,d5ial ( reque/ = he>+ ,if ! ,secret>y det]m9es t in=mation submitt$ 9 a reque/ = a he>+ "u subp>agraph 7,a7 ) respect to a f9al adm9i/rative ord] issu$ "u p>agraph 7#b77;,a77iv7 does n id5tify ! exi/5ce ( a g5u9e & sub/antial "q ( mat]ial fact1 ! ,secret>y may d5y su* reque/4 ,9 mak+ su* a det]m9ation1 ! ,secret>y may consid] only in=mation & data t are bas$ on relevant & reliable sci5tific pr9ciples & me?odologies4 7ii7 ,s+le he>+ = multiple relat$ reque/s ,if m ?an "o reque/ = a he>+ is submitt$ ) respect to ! same adm9i/rative ord] "u subp>agraph 7,a71 ! ,secret>y may direct t a s+le he>+ be conduct$ 9 :i* all p]sons ^: he>+ reque/s 7 grant$ may p>ticipate4 7iii7 ,presid+ (fic] ,! presid+ (fic] ( a he>+ reque/$ "u subp>agraph 7,a7 %all-- 7,i7 be designat$ by ! ,secret>y2 7,,ii7 n be an employee ( ! ,c5t] = ,drug ,evaluation & ,rese>*2 & 7,,iii7 n h be5 previ\sly involv$ 9 ! developm5t ( ! adm9i/rative ord] involv$ or proce$+s relat+ to t adm9i/rative ord]4 7iv7 ,rights ( p>ties to he>+ ,! p>ties to a he>+ reque/$ "u subp>agraph 7,a7 %all h ! "r to pres5t te/imony1 includ+ te/imony ( exp]t witnesses1 & to cross-exam9e witnesses pres5t$ by o!r p>ties4 ,:]e appropriate1 ! presid+ (fic] may require t cross-exam9ation by p>ties repres5t+ sub/antially ! same int]e/s be consolidat$ to promote effici5cy & avoid duplication4 7v7 ,f9al decision 7,i7 ,at ! conclusion ( a he>+ reque/$ "u subp>agraph 7,a71 ! presid+ (fic] ( ! he>+ %all issue a decision conta9+ f9d+s ( fact & conclusions ( law4 ,! decision ( ! presid+ (fic] %all be f9al4 7,,ii7 ,! f9al decision may n take effect until ! p]iod "u subp>agraph 7,d77ii7 = submitt+ a reque/ = judicial review ( su* decision expires4 7,d7 ,judicial review ( f9al adm9i/rative ord] 7i7 ,9 g5]al ,! proc$ures describ$ 9 section #eje7;h7 %all apply ) respect to judicial review ( f9al adm9i/rative ord]s issu$ "u ?is subsection 9 ! same mann] & to ! same ext5t z su* section applies to an ord] describ$ 9 su* section except t ! judicial review %all be tak5 by fil+ 9 an appropriate di/rict c\rt ( ! ,unit$ ,/ates 9 lieu ( ! appellate c\rts specifi$ 9 su* section4 7ii7 ,p]iod to submit a reque/ = judicial review ,a p]son eligible to reque/ a he>+ "u ?is p>agraph & seek+ judicial review ( a f9al adm9i/rative ord] issu$ "u ?is subsection %all file su* reque/ = judicial review n lat] ?an #fj cal5d> days aft] ! late/ (-- 7,i7 ! date on :i* notice ( su* ord] is publi%$2 7,,ii7 ! date on :i* a he>+ ) respect to su* ord] is d5i$ "u subp>agraph 7,b7 or 7,c77i72 7,,iii7 ! date on :i* a f9al decision is made foll[+ a he>+ "u subp>agraph 7,c77v72 or 7,,iv7 if no he>+ is reque/$1 ! date on :i* ! "t = reque/+ a he>+ expires4 7#d7 ,exp$it$ proc$ure ) respect to adm9i/rative ord]s initiat$ by ! ,secret>y 7,a7 ,imm95t haz>d to ! public heal? 7i7 ,9 g5]al ,9 ! case ( a det]m9ation by ! ,secret>y t a drug1 class ( drugs1 or comb9ation ( drugs subject to ?is section poses an imm95t haz>d to ! public heal?1 ! ,secret>y1 aft] fir/ mak+ reasonable ef=ts to notify1 n lat] ?an #dh h\rs be=e issuance ( su* ord] "u ?is subp>agraph1 sponsors :o h a li/+ 9 effect "u section #eaj7;j7 = su* drug or comb9ation ( drugs-- 7,i7 may issue an int]im f9al adm9i/rative ord] = su* drug1 class ( drugs1 or comb9ation ( drugs "u p>agraph 7#a71 toge!r ) a detail$ /atem5t ( ! reasons = su* ord]2 7,,ii7 %all publi% 9 ! ,f$]al ,regi/] a notice ( availability ( any su* ord]2 & 7,,iii7 %all provide = a public comm5t p]iod ( at lea/ #de cal5d> days ) respect to su* int]im f9al ord]4 7ii7 ,nondelegation ,! ,secret>y may n delegate ! au?ority to issue an int]im f9al adm9i/rative ord] "u ?is subp>agraph4 7,b7 ,safety label+ *anges 7i7 ,9 g5]al ,9 ! case ( a det]m9ation by ! ,secret>y t a *ange 9 ! label+ ( a drug1 class ( drugs1 or comb9ation ( drugs subject to ?is section is reasonably expect$ to mitigate a significant or unreasonable risk ( a s]i\s adv]se ev5t associat$ ) use ( ! drug1 ! ,secret>y may-- 7,i7 make reasonable ef=ts to notify in=mally1 n lat] ?an #dh h\rs be=e ! issuance ( ! int]im f9al ord]1 ! sponsors ( drugs :o h a li/+ 9 effect "u section #eaj7;j7 = su* drug or comb9ation ( drugs2 7,,ii7 aft] reasonable ef=ts ( notification1 issue an int]im f9al adm9i/rative ord] 9 accordance ) p>agraph 7#a7 to require su* *ange1 toge!r ) a detail$ /atem5t ( ! reasons = su* ord]2 7,,iii7 publi% 9 ! ,f$]al ,regi/] a notice ( availability ( su* ord]2 & 7,,iv7 provide = a public comm5t p]iod ( at lea/ #de cal5d> days ) respect to su* int]im f9al ord]4 7ii7 ,cont5t ( ord] ,an int]im f9al ord] issu$ "u ?is subp>agraph ) respect to ! label+ ( a drug may provide = new w>n+s & o!r in=mation requir$ = safe use ( ! drug4 7,c7 ,effective date ,an ord] "u subp>agraph 7,a7 or 7,b7 %all take effect on a date specifi$ by ! ,secret>y4 7,d7 ,f9al ord] ,aft] ! completion ( ! proce$+s 9 subp>agraph 7,a7 or 7,b71 ! ,secret>y %all-- 7i7 issue a f9al ord] 9 accordance ) p>agraph 7#a72 7ii7 publi% a notice ( availability ( su* f9al adm9i/rative ord] 9 ! ,f$]al ,regi/]2 & 7iii7 af=d sponsors ( su* drugs t w be subject to su* an ord] ! opportunity = =mal dispute resolution up to ! level ( ! ,director ( ! ,c5t] = ,drug ,evaluation & ,rese>*1 :i* mu/ initially be )9 #de cal5d> days ( ! issuance ( ! ord]1 & = subsequ5t levels ( appeal1 )9 #cj cal5d> days ( ! prior decision4 7,e7 ,he>+s ,a sponsor ( a drug subject to a f9al ord] issu$ "u subp>agraph 7,d7 & t p>ticipat$ 9 ea* /age ( =mal dispute resolution "u clause 7iii7 ( su* subp>agraph may reque/ a he>+ on su* ord]4 ,! provisions ( subp>agraphs 7,a71 7,b71 & 7,c7 ( p>agraph 7#c71 o!r ?an p>agraph 7#c77;,c77v77,,ii71 %all apply ) respect to a he>+ on su* ord] 9 ! same mann] & to ! same ext5t z su* provisions apply ) respect to a he>+ on an adm9i/rative ord] issu$ "u p>agraph 7#b77;,a77iv74 7,f7 ,tim+ 7i7 ,f9al ord] & he>+ ,! ,secret>y %all-- 7,i7 n lat] ?an #f mon?s aft] ! date on :i* ! comm5t p]iod closes "u subp>agraph 7,a7 or 7,b71 issue a f9al ord] 9 accordance ) p>agraph 7#a72 & 7,,ii7 n lat] ?an #ab mon?s aft] ! date on :i* su* f9al ord] is issu$1 complete any he>+ "u subp>agraph 7,e74 7ii7 ,dispute resolution reque/ ,! ,secret>y %all specify 9 an int]im f9al ord] issu$ "u subp>agraph 7,a7 or 7,b7 su* %ort] p]iods = reque/+ dispute resolution "u subp>agraph 7,d77iii7 z are necess>y to meet ! requirem5ts ( ?is subp>agraph4 7,g7 ,judicial review ,a f9al ord] issu$ pursuant to subp>agraph 7,f7 %all be subject to judicial review 9 accordance ) p>agraph 7#c77;,d74 7#e7 ,adm9i/rative ord] initiat$ at ! reque/ ( a reque/or 7,a7 ,9 g5]al ,9 issu+ an adm9i/rative ord] "u p>agraph 7#a7 at ! reque/ ( a reque/or ) respect to c]ta9 drugs1 classes ( drugs1 or comb9ations ( drugs-- 7i7 ! ,secret>y %all1 aft] receiv+ a reque/ "u ?is subp>agraph1 det]m9e :e!r ! reque/ is suffici5tly complete & =matt$ to p]mit a sub/antive review2 7ii7 if ! ,secret>y det]m9es t ! reque/ is suffici5tly complete & =matt$ to p]mit a sub/antive review1 ! ,secret>y %all-- 7,i7 file ! reque/2 & 7,,ii7 initiate proce$+s ) respect to issu+ an adm9i/rative ord] 9 accordance ) p>agraphs 7#b7 & 7#c72 & 7iii7 except z provid$ 9 p>agraph 7#f71 if ! ,secret>y det]m9es t a reque/ does n meet ! requirem5ts = fil+ or is n suffici5tly complete & =matt$ to p]mit a sub/antive review1 ! reque/or may dem& t ! reque/ be fil$ ov] prote/1 & ! ,secret>y %all initiate proce$+s to review ! reque/ 9 accordance ) p>agraph 7#b77;,a74 7,b7 ,reque/ to initiate proce$+s 7i7 ,9 g5]al ,a reque/or seek+ an adm9i/rative ord] "u p>agraph 7#a7 ) respect to c]ta9 drugs1 classes ( drugs1 or comb9ations ( drugs1 %all submit to ! ,secret>y a reque/ to initiate proce$+s = su* ord] 9 ! =m & mann] z specifi$ by ! ,secret>y4 ,su* reque/or may submit a reque/ "u ?is subp>agraph = ! issuance ( an adm9i/rative ord]-- 7,i7 det]m9+ :e!r a drug is g5]ally recogniz$ z safe & effective "u section #bja7p77#a71 exempt f section #ejc7;b77#a71 & n requir$ to be ! subject ( an approv$ application "u section #eje2 or 7,,ii7 det]m9+ :e!r a *ange to a condition ( use ( a drug is g5]ally recogniz$ z safe & effective "u section #bja7p77#a71 exempt f section #ejc7;b77#a71 & n requir$ to be ! subject ( an approv$ application "u section #eje1 if1 abs5t su* a *ang$ condition ( use1 su* drug is-- 7aa7 g5]ally recogniz$ z safe & effective "u section #bja7p77#a7 9 accordance ) subsection 7a77#a71 7a77#b71 or an ord] "u ?is subsection2 or 7bb7 subject to subsection 7a77#c71 b only if su* reque/or initiates su* reque/ 9 conjunction ) a reque/ = ! ,secret>y to det]m9e :e!r su* drug is g5]ally recogniz$ z safe & effective "u section #bja7p77#a71 :i* is fil$ by ! ,secret>y "u subp>agraph 7,a77ii74 7ii7 ,exception ,! ,secret>y is n requir$ to complete review ( a reque/ = a *ange describ$ 9 clause 7i77,,ii7 if ! ,secret>y det]m9es t !re is an inadequate basis to f9d ! drug is g5]ally recogniz$ z safe & effective "u section #bja7p77#a7 "u p>agraph 7#a7 & issues a f9al ord] ann\nc+ t det]m9ation4 7iii7 ,)drawal ,! reque/or may )draw a reque/ "u ?is p>agraph1 accord+ to ! proc$ures set =? pursuant to subsection 7d77#b77;,b74 ,not)/&+ any o!r provision ( ?is section1 if su* reque/ is )drawn1 ! ,secret>y may cease proce$+s "u ?is subp>agraph4 7,c7 ,exclusivity 7i7 ,9 g5]al ,a f9al adm9i/rative ord] issu$ 9 response to a reque/ "u ?is section %all h ! effect ( au?oriz+ solely ! ord] reque/or 7or ! lic5sees1 assignees1 or successors 9 int]e/ ( su* reque/or ) respect to ! subject ( su* ord]71 = a p]iod ( #ah mon?s foll[+ ! effective date ( su* f9al ord] & beg9n+ on ! date ! reque/or may lawfully m>ket su* drugs pursuant to ! ord]1 to m>ket drugs-- 7,i7 incorporat+ *anges describ$ 9 clause 7ii72 & 7,,ii7 subject to ! limitations "u clause 7iv74 7ii7 ,*anges describ$ ,a *ange describ$ 9 ?is clause is a *ange subject to an ord] specifi$ 9 clause 7i71 :i*-- 7,i7 provides = a drug to conta9 an active +r$i5t 7includ+ any e/] or salt ( ! active +r$i5t7 n previ\sly incorporat$ 9 a drug describ$ 9 clause 7iii72 or 7,,ii7 provides = a *ange 9 ! conditions ( use ( a drug1 = :i* new human data /udies conduct$ or sponsor$ by ! reque/or 7or = :i* ! reque/or has an exclusive "r ( ref]5ce7 7 ess5tial to ! issuance ( su* ord]4 7iii7 ,drugs describ$ ,! drugs describ$ 9 ?is clause are drugs-- 7,i7 specifi$ 9 subsection 7a77#a71 7a77#b71 or 7a77#c72 7,,ii7 subject to a f9al ord] issu$ "u ?is section2 7,,iii7 subject to a f9al sunscre5 ord] 7z def9$ 9 section #ehf7b77;,a772 or 7,,iv7 describ$ 9 subsection 7m77#a71 o!r ?an drugs subject to an active en=cem5t action "u *apt] ,,iii ( ?is ,act4 7iv7 ,limitations on exclusivity 7,i7 ,9 g5]al ,only "o #ah-mon? p]iod "u ?is subp>agraph %all be grant$1 "u ea* ord] describ$ 9 clause 7i71 ) respect to *anges 7to ! drug subject to su* ord]7 :i* are ei!r-- 7aa7 *anges describ$ 9 clause 7ii77,i71 relat+ to active +r$i5ts2 or 7bb7 *anges describ$ 9 clause 7ii77,,ii71 relat+ to conditions ( use4 7,,ii7 ,no exclusivity all[$ ,no exclusivity %all apply to *anges to a drug :i* are-- 7aa7 ! subject ( a ,ti] #b ,,otc monograph ord] reque/ 7z def9$ 9 section #gdd,l72 7bb7 safety-relat$ *anges1 z def9$ by ! ,secret>y1 or any o!r *anges ! ,secret>y consid]s necess>y to assure safe use2 or 7cc7 *anges relat$ to me?ods ( te/+ safety or efficacy4 7v7 ,new human data /udies def9$ ,9 ?is subp>agraph1 ! t]m new human data /udies means cl9ical trials ( safety or effectiv5ess 7includ+ actual use /udies71 ph>macok9etics /udies1 or bioavailability /udies1 ! results ( :i*-- 7,i7 h n be5 reli$ on by ! ,secret>y to support-- 7aa7 a propos$ or f9al det]m9ation t a drug describ$ 9 subclause 7,i71 7,,ii71 or 7,,iii7 ( clause 7iii7 is g5]ally recogniz$ z safe & effective "u section #bja7p77#a72 or 7bb7 approval ( a drug t 0 approv$ "u section #eje2 & 7,,ii7 d n duplicate ! results ( ano!r /udy t 0 reli$ on by ! ,secret>y to support-- 7aa7 a propos$ or f9al det]m9ation t a drug describ$ 9 subclause 7,i71 7,,ii71 or 7,,iii7 ( clause 7iii7 is g5]ally recogniz$ z safe & effective "u section #bja7p77#a72 or 7bb7 approval ( a drug t 0 approv$ "u section #eje4 7vi7 ,notification ( drug n available = sale ,a reque/or t is grant$ exclusivity ) respect to a drug "u ?is subp>agraph %all notify ! ,secret>y 9 writ+ )9 #a ye> ( ! issuance ( ! f9al adm9i/rative ord] if ! drug t is ! subject ( su* ord] w n be available = sale )9 #a ye> ( ! date ( issuance ( su* ord]4 ,! reque/or %all include ) su* notice !-- 7,i7 id5tity ( ! drug by e/abli%$ "n & by propriet>y "n1 if any2 7,,ii7 /r5g? ( ! drug2 7,,iii7 date on :i* ! drug w be available = sale1 if kn[n2 & 7,,iv7 reason = n m>ket+ ! drug aft] issuance ( ! ord]4 7#f7 ,in=mation reg>d+ safe nonprescription m>ket+ & use z condition = fil+ a g5]ally recogniz$ z safe & effective reque/ 7,a7 ,9 g5]al ,9 response to a reque/ "u ?is section t a drug describ$ 9 subp>agraph 7,b7 be g5]ally recogniz$ z safe & effective1 ! ,secret>y-- 7i7 may file su* reque/1 if ! reque/ includes in=mation specifi$ "u subp>agraph 7,c7 ) respect to safe nonprescription m>ket+ & use ( su* drug2 or 7ii7 if ! reque/ fails to include in=mation specifi$ "u subp>agraph 7,c71 %all refuse to file su* reque/ & require t nonprescription m>ket+ ( ! drug be pursuant to a new drug application z describ$ 9 subp>agraph 7,d74 7,b7 ,drug describ$ ,a drug describ$ 9 ?is subp>agraph is a nonprescription drug :i* conta9s an active +r$i5t n previ\sly incorporat$ 9 a drug-- 7i7 specifi$ 9 subsection 7a77#a71 7a77#b71 or 7a77#c72 7ii7 subject to a f9al ord] "u ?is section2 or 7iii7 subject to a f9al sunscre5 ord] 7z def9$ 9 section #ehf7b77;,a774 7,c7 ,in=mation demon/rat+ prima facie safe nonprescription m>ket+ & use ,in=mation specifi$ 9 ?is subp>agraph1 ) respect to a reque/ describ$ 9 subp>agraph 7,a77i71 is-- 7i7 in=mation suffici5t = a prima facie demon/ration t ! drug subject to su* reque/ has a v]ifiable hi/ory ( be+ m>ket$ & safely us$ by consum]s 9 ! ,unit$ ,/ates z a nonprescription drug "u comp>able conditions ( use2 7ii7 if ! drug has n be5 previ\sly m>ket$ 9 ! ,unit$ ,/ates z a nonprescription drug1 in=mation suffici5t = a prima facie demon/ration t ! drug 0 m>ket$ & safely us$ "u comp>able conditions ( m>ket+ & use 9 a c\ntry li/$ 9 section #hjb7;b77#a77;,a7 or designat$ by ! ,secret>y 9 accordance ) section #hjb7;b77#a77;,b7-- 7,i7 = su* p]iod z ne$$ to provide reasonable assurances conc]n+ ! safe nonprescription use ( ! drug2 & 7,,ii7 dur+ su* "t 0 subject to suffici5t monitor+ by a regulatory body consid]$ acceptable by ! ,secret>y = su* monitor+ purposes1 includ+ = adv]se ev5ts associat$ ) nonprescription use ( ! drug2 or 7iii7 if ! ,secret>y det]m9es t in=mation describ$ 9 clause 7i7 or 7ii7 is n ne$$ to provide a prima facie demon/ration t ! drug c be safely m>ket$ & us$ z a nonprescription drug1 su* o!r in=mation ! ,secret>y det]m9es is suffici5t = su* purposes4 7,d7 ,m>ket+ pursuant to new drug application ,9 ! case ( a reque/ describ$ 9 subp>agraph 7,a77ii71 ! drug subject to su* reque/ may be resubmitt$ = fil+ only if-- 7i7 ! drug is m>ket$ z a nonprescription drug1 "u conditions ( use comp>able to ! conditions specifi$ 9 ! reque/1 = su* p]iod z ! ,secret>y det]m9es appropriate 7n to exce$ #e consecutive ye>s7 pursuant to an application approv$ "u section #eje2 & 7ii7 dur+ su* p]iod1 #a1jjj1jjj retail packages ( ! drug1 or an equival5t quantity z det]m9$ by ! ,secret>y1 7 di/ribut$ = retail sale1 z det]m9$ 9 su* mann] z ! ,secret>y f9ds appropriate4 7,e7 ,rule ( application ,except 9 ! case ( a reque/ involv+ a drug describ$ 9 section #ehf7i71 z 9 effect on ,janu>y #a1 #bjag1 if ! ,secret>y refuses to file a reque/ "u ?is p>agraph1 ! reque/or may n file su* reque/ ov] prote/ "u p>agraph 7#e77;,a77iii74 7#g7 ,packag+ ,an adm9i/rative ord] issu$ "u p>agraph 7#b71 7#d77;,a71 or 7#e7 may include requirem5ts = ! packag+ ( a drug to enc\rage use 9 accordance ) label+4 ,su* requirem5ts may include unit dose packag+1 requirem5ts = products int5d$ = use by p$iatric populations1 requirem5ts to r$uce risk ( h>m f unsup]vis$ +e/ion1 & o!r appropriate requirem5ts4 ,?is p>agraph does n au?orize ! ,food & ,drug ,adm9i/ration to require /&>ds or te/+ proc$ures z describ$ 9 "p #agjj ( title #af1 ,code ( ,f$]al ,regulations4 7#h7 ,f9al & t5tative f9al monographs = category ,i drugs deem$ f9al adm9i/rative ord]s 7,a7 ,9 g5]al ,a f9al monograph or t5tative f9al monograph describ$ 9 subp>agraph 7,b7 %all be deem$ to be a f9al adm9i/rative ord] "u ?is subsection & may be am5d$1 revok$1 or o!rwise modifi$ 9 accordance ) ! proc$ures ( ?is subsection4 7,b7 ,monographs describ$ ,= purposes ( subp>agraph 7,a71 a f9al monograph or t5tative f9al monograph is describ$ 9 ?is subp>agraph if x-- 7i7 e/abli%es conditions ( use = a drug describ$ 9 p>agraph 7#a7 or 7#b7 ( subsection 7a72 & 7ii7 repres5ts ! mo/ rec5tly promulgat$ v]sion ( su* conditions1 includ+ z modifi$1 9 :ole or 9 "p1 by any propos$ or f9al rule4 7,c7 ,deem$ ord]s include h>moniz+ te*nical am5dm5ts ,! deem$ e/abli%m5t ( a f9al adm9i/rative ord] "u subp>agraph 7,a7 %all be con/ru$ to include any te*nical am5dm5ts to su* ord] z ! ,secret>y det]m9es necess>y to ensure t su* ord] is appropriately h>moniz$1 9 t]ms ( t]m9ology or cross-ref]5ces1 ) ! applicable provisions ( ?is ,act 7& regulations !reund]7 & any o!r ord]s issu$ "u ?is section4 7c7 ,proc$ure = m9or *anges 7#a7 ,9 g5]al ,m9or *anges 9 ! dosage =m ( a drug t is describ$ 9 p>agraph 7#a7 or 7#b7 ( subsection 7a7 or ! subject ( an ord] issu$ "u subsection 7b7 may be made by a reque/or )\t ! issuance ( an ord] "u subsection 7b7 if-- 7,a7 ! reque/or ma9ta9s su* in=mation z is necess>y to demon/rate t ! *ange-- 7i7 w n affect ! safety or effectiv5ess ( ! drug2 & 7ii7 w n mat]ially affect ! ext5t ( absorption or o!r exposure to ! active +r$i5t 9 comp>ison to a suitable ref]5ce product2 & 7,b7 ! *ange is 9 con=mity ) ! requirem5ts ( an applicable adm9i/rative ord] issu$ by ! ,secret>y "u p>agraph 7#c74 7#b7 ,additional in=mation 7,a7 ,access to records ,a sponsor %all submit records reque/$ by ! ,secret>y relat+ to su* a m9or *ange "u section #gjd7;a77#d71 )9 #ae bus9ess days ( receiv+ su* a reque/1 or su* long] p]iod z ! ,secret>y may provide4 7,b7 ,insuffici5t in=mation ,if ! ,secret>y det]m9es t ! in=mation conta9$ 9 su* records is n suffici5t to demon/rate t ! *ange does n affect ! safety or effectiv5ess ( ! drug or mat]ially affect ! ext5t ( absorption or o!r exposure to ! active +r$i5t1 ! ,secret>y-- 7i7 may s in=m ! sponsor ( ! drug 9 writ+2 & 7ii7 if ! ,secret>y s in=ms ! sponsor1 %all provide ! sponsor ( ! drug ) a reasonable opportunity to provide additional in=mation4 7,c7 ,failure to submit suffici5t in=mation ,if ! sponsor fails to provide su* additional in=mation )9 a "t prescrib$ by ! ,secret>y1 or if ! ,secret>y det]m9es t su* additional in=mation does n demon/rate t ! *ange does n-- 7i7 affect ! safety or effectiv5ess ( ! drug2 or 7ii7 mat]ially affect ! ext5t ( absorption or o!r exposure to ! active +r$i5t 9 comp>ison to a suitable ref]5ce product1 ! drug z modifi$ is a new drug "u section #bja7p7 & %all be deem$ to be misbr&$ "u section #ejb7;ee74 7#c7 ,det]m9+ :e!r a *ange w affect safety or effectiv5ess 7,a7 ,9 g5]al ,! ,secret>y %all issue "o or m adm9i/rative ord]s specify+ requirem5ts = det]m9+ :e!r a m9or *ange made by a sponsor pursuant to ?is subsection w affect ! safety or effectiv5ess ( a drug or mat]ially affect ! ext5t ( absorption or o!r exposure to an active +r$i5t 9 ! drug 9 comp>ison to a suitable ref]5ce product1 toge!r ) guidance = apply+ ^? ord]s to specific dosage =ms4 7,b7 ,/&>d practices ,! ord]s & guidance issu$ by ! ,secret>y "u subp>agraph 7,a7 %all take into acc\nt relevant public /&>ds & /&>d practices = evaluat+ ! quality ( drugs1 & may take into acc\nt ! special ne$s ( populations1 includ+ *ildr54 7d7 ,confid5tiality ( in=mation submitt$ to ! ,secret>y 7#a7 ,9 g5]al ,subject to p>agraph 7#b71 any in=mation1 includ+ reports ( te/+ conduct$ on ! drug or drugs involv$1 t is submitt$ by a reque/or 9 connection ) proce$+s on an ord] "u ?is section 7includ+ any m9or *ange "u subsection 7c77 & is a trade secret or confid5tial in=mation subject to section #eeb7;b77#d7 ( title #e1 ,unit$ ,/ates ,code1 or section #aije ( title #ah1 ,unit$ ,/ates ,code1 %all n be disclos$ to ! public unless ! reque/or cons5ts to t disclosure4 7#b7 ,public availability 7,a7 ,9 g5]al ,except z provid$ 9 subp>agraph 7,b71 ! ,secret>y %all-- 7i7 make any in=mation submitt$ by a reque/or 9 support ( a reque/ "u subsection 7b77#e77;,a7 available to ! public n lat] ?an ! date on :i* ! propos$ ord] is issu$2 & 7ii7 make any in=mation submitt$ by any o!r p]son ) respect to an ord] reque/$ 7or initiat$ by ! ,secret>y7 "u subsection 7b71 available to ! public ^u su* submission4 7,b7 ,limitations on public availability ,in=mation describ$ 9 subp>agraph 7,a7 %all n be made public if-- 7i7 ! in=mation p]ta9s to ph>maceutical quality in=mation1 unless su* in=mation is necess>y to e/abli% /&>ds "u :i* a drug is g5]ally recogniz$ z safe & effective "u section #bja7p77#a72 7ii7 ! in=mation is submitt$ 9 a reque/or-initiat$ reque/1 b ! reque/or )draws su* reque/1 9 accordance ) )drawal proc$ures e/abli%$ by ! ,secret>y1 be=e ! ,secret>y issues ! propos$ ord]2 7iii7 ! ,secret>y reque/s & obta9s ! in=mation "u subsection 7c7 & su* in=mation is n submitt$ 9 relation to an ord] "u subsection 7b72 or 7iv7 ! in=mation is ( ! type conta9$ 9 raw datasets4 7e7 ,updates to drug li/+ in=mation ,a sponsor :o makes a *ange to a drug subject to ?is section %all submit updat$ drug li/+ in=mation = ! drug 9 accordance ) section #eaj7;j7 )9 #cj cal5d> days ( ! date :5 ! drug is fir/ comm]cially m>ket$1 except t a sponsor :o 0 ! ord] reque/or ) respect to an ord] subject to subsection 7b77#e77;,c7 7or a lic5see1 assignee1 or successor 9 int]e/ ( su* reque/or7 %all submit updat$ drug li/+ in=mation on or be=e ! date :5 ! drug is fir/ comm]cially m>ket$4 7f7 ,approvals "u section #eje ,! provisions ( ?is section %all n be con/ru$ to preclude a p]son f seek+ or ma9ta9+ ! approval ( an application = a drug "u sections #eje7;b77#a71 #eje7;b77#b71 & #eje7;j74 ,a det]m9ation "u ?is section t a drug is n subject to section #ejc7;b77#a71 is g5]ally recogniz$ z safe & effective "u section #bja7p77#a71 & is n a new drug "u section #bja7p7 %all con/itute a f9d+ t ! drug is safe & effective t may be reli$ ^u = purposes ( an application "u section #eje7;b77#b71 s t ! applicant %all be requir$ to submit = purposes ( su* application only in=mation ne$$ to support any modification ( ! drug t is n cov]$ by su* det]m9ation "u ?is section4 7g7 ,public availability ( adm9i/rative ord]s ,! ,secret>y %all e/abli%1 ma9ta91 update 7z det]m9$ necess>y by ! ,secret>y b no less frequ5tly ?an annually71 & make publicly available1 ) respect to ord]s issu$ "u ?is section-- 7#a7 a repository ( ea* f9al ord] & int]im f9al ord] 9 effect1 includ+ ! complete text ( ! ord]2 & 7#b7 a li/+ ( all ord]s propos$ & "u developm5t "u subsection 7b77#b71 includ+-- 7,a7 a brief description ( ea* su* ord]2 & 7,b7 ! ,secret>y's expectations1 if res\rces p]mit1 = issuance ( propos$ ord]s ov] a #c-ye> p]iod4 7h7 ,developm5t advice to sponsors or reque/ors ,! ,secret>y %all e/abli% proc$ures "u :i* sponsors or reque/ors may meet ) appropriate (ficials ( ! ,food & ,drug ,adm9i/ration to obta9 advice on ! /udies & o!r in=mation necess>y to support submissions "u ?is section & o!r matt]s relevant to ! regulation ( nonprescription drugs & ! developm5t ( new nonprescription drugs "u ?is section4 7i7 ,p>ticipation ( multiple sponsors or reque/ors ,! ,secret>y %all e/abli% proc$ures to facilitate effici5t p>ticipation by multiple sponsors or reque/ors 9 proce$+s "u ?is section1 includ+ provision = jo9t meet+s ) multiple sponsors or reque/ors or ) organizations nom9at$ by sponsors or reque/ors to repres5t _! int]e/s 9 a proce$+4 7j7 ,electronic =mat ,all submissions "u ?is section %all be 9 electronic =mat4 7k7 ,effect on exi/+ regulations gov]n+ nonprescription drugs 7#a7 ,regulations ( g5]al applicability to nonprescription drugs ,except z provid$ 9 ?is subsection1 no?+ 9 ?is section sup]s$es regulations e/abli%+ g5]al requirem5ts = nonprescription drugs1 includ+ regulations ( g5]al applicability conta9$ 9 p>ts #bja1 #bej1 & #ccj ( title #ba1 ,code ( ,f$]al ,regulations1 or any successor regulations4 ,! ,secret>y %all e/abli% or modify su* regulations by means ( rulemak+ 9 accordance ) section #eec ( title #e1 ,unit$ ,/ates ,code4 7#b7 ,regulations e/abli%+ requirem5ts = specific nonprescription drugs 7,a7 ,! provisions ( section #caj4ede ( title #ba1 ,code ( ,f$]al ,regulations1 z 9 effect on ! day be=e ! date ( ! enactm5t ( ?is section1 %all be deem$ to be a f9al ord] "u subsection 7b74 7,b7 ,regulations 9 effect on ! day be=e ! date ( ! enactm5t ( ?is section1 e/abli%+ requirem5ts = specific nonprescription drugs m>ket$ pursuant to ?is section 7includ+ su* requirem5ts 9 p>ts #bja & #bej ( title #ba1 ,code ( ,f$]al ,regulations71 %all be deem$ to be f9al ord]s "u subsection 7b71 only z !y apply to drugs-- 7i7 subject to p>agraph 7#a71 7#b71 7#c71 or 7#d7 ( subsection 7a72 or 7ii7 o!rwise subject to an ord] "u ?is section4 7#c7 ,)drawal ( regulations ,! ,secret>y %all )draw regulations e/abli%+ f9al monographs & ! proc$ures gov]n+ ! ov]-!-c\nt] drug review "u "p #ccj & o!r relevant p>ts ( title #ba1 ,code ( ,f$]al ,regulations 7z 9 effect on ! day be=e ! date ( ! enactm5t ( ?is section71 or make te*nical *anges to su* regulations to ensure con=mity ) appropriate t]m9ology & cross ref]5ces4 ,not)/&+ sub*apt] ,,ii ( *apt] #e ( title #e1 ,unit$ ,/ates ,code1 any su* )drawal or te*nical *anges %all be made )\t public notice & comm5t & %all be effective ^u publication ?r\gh notice 9 ! ,f$]al ,regi/] 7or ^u su* date z specifi$ 9 su* notice74 7l7 ,guidance ,! ,secret>y %all issue guidance t specifies-- 7#a7 ! proc$ures & pr9ciples = =mal meet+s betwe5 ! ,secret>y & sponsors or reque/ors = drugs subject to ?is section2 7#b7 ! =mat & cont5t ( data submissions to ! ,secret>y "u ?is section2 7#c7 ! =mat ( electronic submissions to ! ,secret>y "u ?is section2 7#d7 consolidat$ proce$+s = appeal & ! proc$ures = su* proce$+s :]e appropriate2 & 7#e7 = m9or *anges 9 drugs1 recomm5dations on h[ to comply ) ! requirem5ts 9 ord]s issu$ "u subsection 7c77#c74 7m7 ,rule ( con/ruction 7#a7 ,9 g5]al ,?is section %all n affect ! treatm5t or /atus ( a nonprescription drug-- 7,a7 t is m>ket$ )\t an application approv$ "u section #eje z ( ! date ( ! enactm5t ( ?is section2 7,b7 t is n subject to an ord] issu$ "u ?is section2 & 7,c7 to :i* p>agraph 7#a71 7#b71 7#c71 7#d71 or 7#e7 ( subsection 7a7 d n apply4 7#b7 ,treatm5t ( products previ\sly f\nd to be subject to "t & ext5t requirem5ts 7,a7 ,not)/&+ subsection 7a71 a drug describ$ 9 subp>agraph 7,b7 may only be lawfully m>ket$1 )\t an application approv$ "u section #eje1 pursuant to an ord] issu$ "u ?is section4 7,b7 ,a drug describ$ 9 ?is subp>agraph is a drug :i*1 prior to ! date ( ! enactm5t ( ?is section1 ! ,secret>y det]m9$ 9 a propos$ or f9al rule to be ineligible = review "u ! ,,otc drug review 7z su* phrase ,,otc drug review 0 us$ 9 section #ccj4ad ( title #ba1 ,code ( ,f$]al ,regulations1 z 9 effect on ! day be=e ! date ( ! enactm5t ( ?is section74 7#c7 ,pres]vation ( au?ority 7,a7 ,no?+ 9 p>agraph 7#a7 %all be con/ru$ to preclude or limit ! applicability ( any provision ( ?is ,act o!r ?an ?is section4 7,b7 ,no?+ 9 subsection 7a7 %all be con/ru$ to prohibit ! ,secret>y f issu+ an ord] "u ?is section f9d+ a drug to be n g5]ally recogniz$ z safe & effective "u section #bja7p77#a71 z ! ,secret>y det]m9es appropriate4 7n7 ,inve/igational new drugs ,a drug is n subject to ?is section if an exemption = inve/igational use "u section #eje7;i7 is 9 effect = su* drug4 7o7 ,inapplicability ( pap]work r$uction act ,*apt] #ce ( title #dd1 ,unit$ ,/ates ,code1 %all n apply to collections ( in=mation made "u ?is section4 7p7 ,inapplicability ( notice & comm5t rulemak+ & o!r requirem5ts ,! requirem5ts ( subsection 7b7 %all apply ) respect to ord]s issu$ "u ?is section in/ead ( ! requirem5ts ( sub*apt] ,,ii ( *apt] #e ( title #e1 ,unit$ ,/ates ,code4 7q7 ,def9itions ,9 ?is section3 7#a7 ,! t]m nonprescription drug ref]s to a drug n subject to ! requirem5ts ( section #ejc7;b77#a74 7#b7 ,! t]m sponsor ref]s to any p]son m>ket+1 manufactur+1 or process+ a drug t-- 7,a7 is li/$ pursuant to section #eaj7;j72 & 7,b7 is or w be subject to an adm9i/rative ord] "u ?is section ( ! ,food & ,drug ,adm9i/ration4 7#c7 ,! t]m reque/or ref]s to any p]son or gr\p ( p]sons m>ket+1 manufactur+1 process+1 or develop+ a drug4 4 7b7 ,,gao /udy ,n lat] ?an #d ye>s aft] ! date ( enactm5t ( ?is ,act1 ! ,comptroll] ,g5]al ( ! ,unit$ ,/ates %all submit a /udy to ! ,committee on ,en]gy & ,comm]ce ( ! ,h\se ( ,repres5tatives & ! ,committee on ,heal?1 ,education1 ,labor1 & ,p5sions ( ! ,s5ate address+ ! effectiv5ess & ov]all impact ( exclusivity "u section #eje;,g ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act1 z add$ by subsection 7a71 & section #ehf;,c ( su* ,act 7#ba ,u4,s4,c4 #cfj;fff-#c71 includ+ ! impact ( su* exclusivity on consum] access4 ,su* /udy %all include-- 7#a7 an analysis ( ! impact ( exclusivity "u su* section #eje;,g = nonprescription drug products1 includ+-- 7,a7 ! numb] ( nonprescription drug products t 7 grant$ exclusivity & ! indication = :i* ! nonprescription drug products 7 det]m9$ to be g5]ally recogniz$ z safe & effective2 7,b7 :e!r ! exclusivity = su* drug products 0 grant$ =-- 7i7 a new active +r$i5t 7includ+ any e/] or salt ( ! active +r$i5t72 or 7ii7 *anges 9 ! conditions ( use ( a drug1 = :i* new human data /udies conduct$ or sponsor$ by ! reque/or 7 ess5tial2 7,c7 :e!r1 & to :at ext5t1 ! exclusivity impact$ ! reque/or's or sponsor's decision to develop ! drug product2 7,d7 an analysis ( ! implem5tation ( ! exclusivity provision 9 su* section #eje;,g1 includ+-- 7i7 ! res\rces us$ by ! ,food & ,drug ,adm9i/ration2 7ii7 ! impact ( su* provision on innovation1 z well z rese>* & developm5t 9 ! nonprescription drug m>ket2 7iii7 ! impact ( su* provision on competition 9 ! nonprescription drug m>ket2 7iv7 ! impact ( su* provision on consum] access to nonprescription drug products2 7v7 ! impact ( su* provision on ! prices ( nonprescription drug products2 & 7vi7 :e!r ! adm9i/rative ord]s initiat$ by reque/ors "u su* section #eje;,g h be5 suffici5t to enc\rage ! developm5t ( nonprescription drug products t w\ld likely n be o!rwise develop$1 or develop$ 9 z timely a mann]2 & 7,e7 :e!r ! adm9i/rative ord]s initiat$ by reque/ors "u su* section #eje;,g h be5 suffici5t inc5tive to enc\rage innovation 9 ! nonprescription drug m>ket2 & 7#b7 an analysis ( ! impact ( exclusivity "u su* section #ehf;,c = sunscre5 +r$i5ts1 includ+-- 7,a7 ! numb] ( sunscre5 +r$i5ts t 7 grant$ exclusivity & ! specific +r$i5t t 0 det]m9$ to be g5]ally recogniz$ z safe & effective2 7,b7 :e!r1 & to :at ext5t1 ! exclusivity impact$ ! reque/or's or sponsor's decision to develop ! sunscre5 +r$i5t2 7,c7 :e!r1 & to :at ext5t1 ! sunscre5 +r$i5t grant$ exclusivity _h previ\sly be5 available outside ( ! ,unit$ ,/ates2 7,d7 an analysis ( ! implem5tation ( ! exclusivity provision 9 su* section #ehf;,c1 includ+-- 7i7 ! res\rces us$ by ! ,food & ,drug ,adm9i/ration2 7ii7 ! impact ( su* provision on innovation1 z well z rese>* & developm5t 9 ! sunscre5 m>ket2 7iii7 ! impact ( su* provision on competition 9 ! sunscre5 m>ket2 7iv7 ! impact ( su* provision on consum] access to sunscre5 products2 7v7 ! impact ( su* provision on ! prices ( sunscre5 products2 & 7vi7 :e!r ! adm9i/rative ord]s initiat$ by reque/ors "u su* section #eje;,g h be5 utiliz$ by sunscre5 +r$i5t sponsors & :e!r su* process has be5 suffici5t to enc\rage ! developm5t ( sunscre5 +r$i5ts t w\ld likely n be o!rwise develop$1 or develop$ 9 z timely a mann]2 & 7,e7 :e!r ! adm9i/rative ord]s initiat$ by reque/ors "u su* section #ehf;,c h be5 suffici5t inc5tive to enc\rage innovation 9 ! sunscre5 m>ket4 7c7 ,con=m+ am5dm5t ,section #gea7;d77#a7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cgir7d77#a77 is am5d$-- 7#a7 9 ! matt] prec$+ subp>agraph 7,a7-- 7,a7 by /rik+ f9al regulation promulgat$ & ins]t+ f9al ord] "u section #eje;,g2 & 7,b7 by /rik+ & n misbr&$2 & 7#b7 9 subp>agraph 7,a71 by /rik+ regulation 9 effect & ins]t+ regulation or ord] 9 effect4 #ajb4 ,misbr&+ ,section #ejb ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #ceb7 is am5d$ by add+ at ! end ! foll[+3 7ee7 ,if x is a nonprescription drug t is subject to section #eje;,g1 is n ! subject ( an application approv$ "u section #eje1 & does n comply ) ! requirem5ts "u section #eje;,g4 7ff7 ,if x is a drug & x 0 manufactur$1 prep>$1 propagat$1 comp\nd$1 or process$ 9 a facility = :i* fees h n be5 paid z requir$ by section #gdd,m4 4 #ajc4 ,drugs exclud$ f ! ov]-!-c\nt] drug review 7a7 ,9 g5]al ,no?+ 9 ?is ,act 7or ! am5dm5ts made by ?is ,act7 %all apply to any nonprescription drug 7z def9$ 9 section #eje;,g7q7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act1 z add$ by section #aja ( ?is ,act7 :i* 0 exclud$ by ! ,food & ,drug ,adm9i/ration f ! ,ov]-!-,c\nt] ,drug ,review 9 accordance ) ! p>agraph numb]$ #be on page #idff ( volume #cg ( ! ,f$]al ,regi/]1 publi%$ on ,may #aa1 #aigb4 7b7 ,rule ( con/ruction ,no?+ 9 ?is section %all be con/ru$ to preclude or limit ! applicability ( any o!r provision ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cja et seq474 #ajd4 ,treatm5t ( ,sunscre5 ,innovation ,act 7a7 ,review ( nonprescription sunscre5 active +r$i5ts 7#a7 ,applicability ( section #eje;,g = p5d+ submissions 7,a7 ,9 g5]al ,a sponsor ( a nonprescription sunscre5 active +r$i5t or comb9ation ( nonprescription sunscre5 active +r$i5ts t1 z ( ! date ( enactm5t ( ?is ,act1 is subject to a propos$ sunscre5 ord] "u section #ehf;,c ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;fff-#c7 may elect1 by means ( giv+ writt5 notification to ! ,secret>y ( ,heal? & ,human ,s]vices )9 #ahj cal5d> days ( ! enactm5t ( ?is ,act1 to transition into ! review ( su* +r$i5t or comb9ation ( +r$i5ts pursuant to ! process set out 9 section #eje;,g ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act1 z add$ by section #aja ( ?is ,act4 7,b7 ,election ex]cis$ ,^u receipt by ! ,secret>y ( ,heal? & ,human ,s]vices ( a timely notification "u subp>agraph 7,a7-- 7i7 ! propos$ sunscre5 ord] involv$ is deem$ to be a reque/ = an ord] "u subsection 7b7 ( section #eje;,g ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act1 z add$ by section #aja ( ?is ,act2 & 7ii7 su* ord] is deem$ to h be5 accept$ = fil+ "u subsection 7b77#f77;,a77i7 ( su* section #eje;,g4 7,c7 ,election n ex]cis$ ,if a notification "u subp>agraph 7,a7 is n receiv$ by ! ,secret>y ( ,heal? & ,human ,s]vices )9 #ahj cal5d> days ( ! date ( enactm5t ( ?is ,act1 ! review ( ! propos$ sunscre5 ord] describ$ 9 subp>agraph 7,a7-- 7i7 %all cont9ue "u section #ehf;,c ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;fff-#c72 & 7ii7 %all n be eligible = review "u section #eje;,g1 add$ by section #aja ( ?is ,act4 7#b7 ,def9itions ,9 ?is subsection1 ! t]ms sponsor1 nonprescription1 sunscre5 active +r$i5t1 & propos$ sunscre5 ord] h ! mean+s giv5 to ^? t]ms 9 section #ehf ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;fff74 7b7 ,am5dm5ts to sunscre5 provisions 7#a7 ,f9al sunscre5 ord]s ,p>agraph 7#c7 ( section #ehf;,c7e7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;fff-#c7;e77 is am5d$ to read z foll[s3 7#c7 ,relation%ip to ord]s "u section #eje;,g ,a f9al sunscre5 ord] %all be deem$ to be a f9al ord] "u section #eje;,g4 4 7#b7 ,meet+s ,p>agraph 7#g7 ( section #ehf;,c7b7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;fff-#c7;b77 is am5d$-- 7,a7 by /rik+ ,a sponsor may reque/ & ins]t+ ! foll[+3 7,a7 ,9 g5]al ,a sponsor may reque/ 2 & 7,b7 by add+ at ! end ! foll[+3 7,b7 ,confid5tial meet+s ,a sponsor may reque/ "o or m confid5tial meet+s ) respect to a propos$ sunscre5 ord]1 includ+ a lett] deem$ to be a propos$ sunscre5 ord] "u p>agraph 7#c71 to discuss matt]s relat+ to data requirem5ts to support a g5]al recognition ( safety & effectiv5ess involv+ confid5tial in=mation & public in=mation relat$ to su* propos$ sunscre5 ord]1 z appropriate4 ,! ,secret>y %all conv5e a confid5tial meet+ ) su* sponsor 9 a reasonable "t p]iod4 ,if a sponsor reque/s m ?an "o confid5tial meet+ = ! same propos$ sunscre5 ord]1 ! ,secret>y may refuse to grant an additional confid5tial meet+ reque/ if ! ,secret>y det]m9es t su* additional confid5tial meet+ is n reasonably necess>y = ! sponsor to advance its propos$ sunscre5 ord]1 or if ! reque/ = a confid5tial meet+ fails to include suffici5t in=mation ^u :i* to base a sub/antive discussion4 ,! ,secret>y %all publi% a po/-meet+ summ>y ( ea* confid5tial meet+ "u ?is subp>agraph t does n disclose confid5tial comm]cial in=mation or trade secrets4 ,?is subp>agraph does n au?orize ! disclosure ( confid5tial comm]cial in=mation or trade secrets subject to #eeb7;b77#d7 ( title #e1 ,unit$ ,/ates ,code1 or section #aije ( title #ah1 ,unit$ ,/ates ,code4 4 7#c7 ,exclusivity ,section #ehf;,c ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;fff-#c7 is am5d$ by add+ at ! end ! foll[+3 7f7 ,exclusivity 7#a7 ,9 g5]al ,a f9al sunscre5 ord] %all h ! effect ( au?oriz+ solely ! ord] reque/or 7or ! lic5sees1 assignees1 or successors 9 int]e/ ( su* reque/or ) respect to ! subject ( su* reque/ & li/$ "u p>agraph 7#e77 = a p]iod ( #ah mon?s1 to m>ket a sunscre5 +r$i5t "u ?is section incorporat+ *anges describ$ 9 p>agraph 7#b7 subject to ! limitations "u p>agraph 7#d71 beg9n+ on ! date ! reque/or 7or any lic5sees1 assignees1 or successors 9 int]e/ ( su* reque/or ) respect to ! subject ( su* reque/ & li/$ "u p>agraph 7#e77 may lawfully m>ket su* sunscre5 +r$i5t pursuant to ! ord]4 7#b7 ,*anges describ$ ,a *ange describ$ 9 ?is p>agraph is a *ange subject to an ord] specifi$ 9 p>agraph 7#a7 t p]mits a sunscre5 to conta9 an active sunscre5 +r$i5t n previ\sly incorporat$ 9 a m>ket$ sunscre5 li/$ 9 p>agraph 7#c74 7#c7 ,m>ket$ sunscre5 ,! m>ket$ sunscre5 +r$i5ts describ$ 9 ?is p>agraph are sunscre5 +r$i5ts-- 7,a7 m>ket$ 9 accordance ) a f9al monograph = sunscre5 drug products set =? at "p #ceb ( title #ba1 ,code ( ,f$]al ,regulations 7z publi%$ at #fd ,f$4 ,reg4 #bgfhg72 or 7,b7 m>ket$ 9 accordance ) a f9al ord] issu$ "u ?is section4 7#d7 ,limitations on exclusivity ,only "o #ah-mon? p]iod may be grant$ p] +r$i5t "u p>agraph 7#a74 7#e7 ,li/+ ( lic5sees1 assignees1 or successors 9 int]e/ ,reque/ors %all submit to ! ,secret>y at ! "t :5 a drug subject to su* reque/ is introduc$ or deliv]$ = introduction into int]/ate comm]ce1 a li/ ( lic5sees1 assignees1 or successors 9 int]e/ "u p>agraph 7#a74 4 7#d7 ,sunset provision ,sub*apt] ,i ( *apt] ,v ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;fff et seq47 is am5d$ by add+ at ! end ! foll[+3 #ehf;,h4 ,sunset ,?is sub*apt] %all cease to be effective at ! end ( fiscal ye> #bjbb4 4 7#e7 ,treatm5t ( f9al sunscre5 ord] ,! ,f$]al ,food1 ,drug1 & ,cosmetic ,act is am5d$ by /rik+ section #ehf;,e ( su* ,act 7#ba ,u4,s4,c4 #cfj;fff-#e74 7c7 ,treatm5t ( ,au?ority ,reg>d+ ,f9alization ( ,sunscre5 ,monograph 7#a7 ,9 g5]al 7,a7 ,revision ( f9al sunscre5 ord] ,! ,secret>y ( ,heal? & ,human ,s]vices 7ref]r$ to 9 ?is subsection z ! ,secret>y7 %all am5d & revise ! f9al adm9i/rative ord] conc]n+ nonprescription sunscre5 7ref]r$ to 9 ?is subsection z ! sunscre5 ord]7 = :i* ! cont5t1 prior to ! date ( enactm5t ( ?is ,act1 0 repres5t$ by ! f9al monograph = sunscre5 drug products set =? 9 "p #ceb ( title #ba1 ,code ( ,f$]al ,regulations 7z 9 effect on ,may #ba1 #aiii74 7,b7 ,issuance ( revis$ sunscre5 ord]2 effective date ,a revis$ sunscre5 ord] describ$ 9 subp>agraph 7,a7 %all be-- 7i7 issu$ 9 accordance ) ! proc$ures describ$ 9 section #eje;,g7b77#b7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act2 7ii7 issu$ 9 propos$ =m n lat] ?an #ah mon?s aft] ! date ( enactm5t ( ?is ,act2 & 7iii7 issu$ by ! ,secret>y at lea/ #a ye> prior to ! effective date ( ! revis$ ord]4 7#b7 ,reports ,if a revis$ sunscre5 ord] issu$ "u p>agraph 7#a7 does n include provisions relat$ to ! effectiv5ess ( v>i\s sun protection factor levels1 & does n address all dosage =ms kn[n to ! ,secret>y to be us$ 9 sunscre5s m>ket$ 9 ! ,unit$ ,/ates )\t a new drug application approv$ "u section #eje ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cee71 ! ,secret>y %all submit a report to ! ,committee on ,en]gy & ,comm]ce ( ! ,h\se ( ,repres5tatives & ! ,committee on ,heal?1 ,education1 ,labor1 & ,p5sions ( ! ,s5ate on ! rationale = omission ( su* provisions f su* ord]1 & a plan & timel9e to compile any in=mation necess>y to address su* provisions ?r\gh su* ord]4 7d7 ,treatm5t ( non-,sunscre5 "t & ext5t applications 7#a7 ,9 g5]al ,any application describ$ 9 section #ehf;,f ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;fff-#f7 t 0 submitt$ to ! ,secret>y pursuant to section #ccj4ad ( title #ba1 ,code ( ,f$]al ,regulations1 z su* provisions 7 9 effect imm$iately prior to ! date ( enactm5t date ( ?is ,act1 %all be ext+ui%$ z ( su* date ( enactm5t1 subject to p>agraph 7#b74 7#b7 ,ord] reque/ ,no?+ 9 p>agraph 7#a7 precludes ! submission ( an ord] reque/ "u section #eje;,g7b7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act1 z add$ by section #aja ( ?is ,act1 ) respect to a drug t 0 ! subject ( an application ext+ui%$ "u p>agraph 7#a74 #aje4 ,annual update to ,congress on appropriate p$iatric indication = c]ta9 ,,otc c\gh & cold drugs 7a7 ,9 g5]al ,subject to subsection 7c71 ! ,secret>y ( ,heal? & ,human ,s]vices %all1 beg9n+ n lat] ?an #a ye> aft] ! date ( enactm5t ( ?is ,act1 annually submit to ! ,committee on ,en]gy & ,comm]ce ( ! ,h\se ( ,repres5tatives & ! ,committee on ,heal?1 ,education1 ,labor1 & ,p5sions ( ! ,s5ate a lett] describ+ ! progress ( ! ,food & ,drug ,adm9i/ration-- 7#a7 9 evaluat+ ! c\gh & cold monograph describ$ 9 subsection 7b7 ) respect to *ildr5 "u age #f2 & 7#b7 z appropriate1 revis+ su* c\gh & cold monograph to address su* *ildr5 ?r\gh ! ord] process "u section #eje;,g7b7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act1 z add$ by section #aja ( ?is ,act4 7b7 ,c\gh & cold monograph describ$ ,! c\gh & cold monograph describ$ 9 ?is subsection consi/s ( ! conditions "u :i* nonprescription drugs conta9+ antitussive1 expectorant1 nasal deconge/ant1 or antihi/am9e active +r$i5ts 7or comb9ations !re(7 are g5]ally recogniz$ z safe & effective1 z specifi$ 9 "p #cda ( title #ba1 ,code ( ,f$]al ,regulations 7z 9 effect imm$iately prior to ! date ( enactm5t ( ?is ,act71 & includ$ 9 an ord] deem$ to be e/abli%$ "u section #eje;,g7b7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act1 z add$ by section #aja ( ?is ,act4 7c7 ,duration ( au?ority ,! requirem5t "u subsection 7a7 %all t]m9ate z ( ! date ( a lett] submitt$ by ! ,secret>y ( ,heal? & ,human ,s]vices pursuant to su* subsection 9 :i* ! ,secret>y indicates t ! ,food & ,drug ,adm9i/ration has complet$ its evaluation & revis$1 9 a f9al ord]1 z applicable1 ! c\gh & cold monograph z describ$ 9 subsection 7a77#b74 #ajf4 ,te*nical corrections 7a7 ,imports & exports ,section #hja7;e77#d77;,e77iii7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cha7;e77#d77;,e77iii77 is am5d$ by /rik+ subp>agraph ea* place su* t]m appe>s & ins]t+ p>agraph4 7b7 ,,fda ,reau?orization ,act ( #bjag 7#a7 ,9 g5]al ,section #ije7;b77#d7 ( ! ,,fda ,reau?orization ,act ( #bjag 7,public ,law #aae-eb7 is am5d$ by /rik+ ,section #gdd;,h7e77#b77;,b7 & ins]t+ ,section #gdd;,h7f77#b77;,b74 7#b7 ,effective date ,! am5dm5t made by p>agraph 7#a7 %all take effect z ( ! enactm5t ( ! ,,fda ,reau?orization ,act ( #bjag 7,public ,law #aae-eb74 ,,ii ,us] ,fees #bja4 ,%ort title2 f9d+ 7a7 ,%ort title ,?is title may be cit$ z ! ,ov]-!-,c\nt] ,monograph ,us] ,fee ,act ( #bjai4 7b7 ,f9d+ ,! ,congress f9ds t ! fees au?oriz$ by ! am5dm5ts made 9 ?is title w be d$icat$ to ,,otc monograph drug activities1 z set =? 9 ! goals id5tifi$ = purposes ( "p #aj ( sub*apt] ,c ( *apt] ,,vii ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act1 9 ! lett]s f ! ,secret>y ( ,heal? & ,human ,s]vices to ! ,*airman ( ! ,committee on ,heal?1 ,education1 ,labor1 & ,p5sions ( ! ,s5ate & ! ,*airman ( ! ,committee on ,en]gy & ,comm]ce ( ! ,h\se ( ,repres5tatives1 z set =? 9 ! ,congressional ,record4 #bjb4 ,fees relat+ to ov]-!-c\nt] drugs ,sub*apt] ,c ( *apt] ,,vii ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;f et seq47 is am5d$ by ins]t+ aft] "p #i ! foll[+3 #aj ,fees ,relat+ to ,ov]-!-,c\nt] ,drugs #gdd,l4 ,def9itions ,9 ?is "p3 7#a7 ,! t]m affiliate means a 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#b7 ,! t]m contract manufactur+ organization facility means an ,,otc monograph drug facility :]e nei!r ! own] ( su* manufactur+ facility nor any affiliate ( su* own] or facility sells ! ,,otc monograph drug produc$ at su* facility directly to :olesal]s1 retail]s1 or consum]s 9 ! ,unit$ ,/ates4 7#c7 ,! t]m co/s ( res\rces allocat$ = ,,otc monograph drug activities means ! exp5ses 9 connection ) ,,otc monograph drug activities =-- 7,a7 (fic]s & employees ( ! ,food & ,drug ,adm9i/ration1 contractors ( ! ,food & ,drug ,adm9i/ration1 advisory committees1 & co/s relat$ to su* (fic]s1 employees1 & committees & co/s relat$ to contracts ) su* contractors2 7,b7 managem5t ( in=mation1 & ! acquisition1 ma9t5ance1 & repair ( comput] res\rces2 7,c7 leas+1 ma9t5ance1 r5ovation1 & repair ( facilities & acquisition1 ma9t5ance1 & repair ( fixtures1 furniture1 sci5tific equipm5t1 & o!r necess>y mat]ials & supplies2 & 7,d7 collect+ fees "u section #gdd,m & acc\nt+ = res\rces allocat$ = ,,otc monograph drug activities4 7#d7 ,! t]m ,,fda e/abli%m5t id5tifi] is ! unique numb] automatically g5]at$ by ,food & ,drug ,adm9i/ration's ,field ,accompli%m5ts & ,compliance ,track+ ,sy/em 7,,facts7 7or any successor sy/em74 7#e7 ,! t]m ,,otc monograph drug means a nonprescription drug )\t an approv$ new drug application :i* is gov]n$ by ! provisions ( section #eje;,g4 7#f7 ,! t]m ,,otc monograph drug activities means activities ( ! ,secret>y associat$ ) ,,otc monograph drugs & inspection ( facilities associat$ ) su* products1 includ+ ! foll[+ activities3 7,a7 ,! activities necess>y = review & evaluation ( ,,otc monographs & ,,otc monograph ord] reque/s1 includ+-- 7i7 ord]s propos+ or f9aliz+ applicable conditions ( use = ,,otc monograph drugs2 7ii7 ord]s affect+ /atus reg>d+ g5]al recognition ( safety & effectiv5ess ( an ,,otc monograph +r$i5t or comb9ation ( +r$i5ts "u specifi$ conditions ( use2 7iii7 all ,,otc monograph drug developm5t & review activities1 includ+ intra-ag5cy collaboration2 7iv7 regulation & policy developm5t activities relat$ to ,,otc monograph drugs2 7v7 developm5t ( product /&>ds = products subject to review & evaluation2 7vi7 meet+s ref]r$ to 9 section #eje;,g7i72 7vii7 review ( label+ prior to issuance ( ord]s relat$ to ,,otc monograph drugs or conditions ( use2 & 7viii7 regulatory sci5ce activities relat$ to ,,otc monograph drugs4 7,b7 ,inspections relat$ to ,,otc monograph drugs4 7,c7 ,monitor+ ( cl9ical & o!r rese>* conduct$ 9 connection ) ,,otc monograph drugs4 7,d7 ,safety activities ) respect to ,,otc monograph drugs1 includ+-- 7i7 collect+1 develop+1 & review+ safety in=mation on ,,otc monograph drugs1 includ+ adv]se ev5t reports2 7ii7 develop+ & us+ improv$ adv]se ev5t data-collection sy/ems1 includ+ in=mation te*nology sy/ems2 & 7iii7 develop+ & us+ improv$ analytical tools to assess pot5tial safety risks1 includ+ access to ext]nal databases4 7,e7 ,o!r activities necess>y = implem5tation ( section #eje;,g4 7#g7 ,! t]m ,,otc monograph ord] reque/ means a reque/ = an ord] submitt$ "u section #eje;,g7b77#e74 7#h7 ,! t]m ,ti] #a ,,otc monograph ord] reque/ means any ,,otc monograph ord] reque/ n det]m9$ to be a ,ti] #b ,,otc monograph ord] reque/4 7#i7 7,a7 ,! t]m ,ti] #b ,,otc monograph ord] reque/ means1 subject to subp>agraph 7,b71 an ,,otc monograph ord] reque/ =-- 7i7 ! reord]+ ( exi/+ in=mation 9 ! drug facts label ( an ,,otc monograph drug2 7ii7 ! addition ( in=mation to ! o!r in=mation section ( ! drug facts label ( an ,,otc monograph drug1 z limit$ by section #bja4ff7;c77#g7 ( title #ba1 ,code ( ,f$]al ,regulations 7or any successor regulations72 7iii7 modification to ! directions = use section ( ! drug facts label ( an ,,otc monograph drug1 if su* *anges con=m to *anges made pursuant to section #eje;,g7c77#c77;,a72 7iv7 ! /&>dization ( ! conc5tration or dose ( a specific f9aliz$ +r$i5t )9 a p>ticul> f9aliz$ monograph2 7v7 a *ange to +r$i5t nom5clature to align ) nom5clature ( a /&>ds-sett+ organization2 or 7vi7 addition ( an int]*angeable t]m 9 accordance ) section #ccj4a ( title #ba1 ,code ( ,f$]al ,regulations 7or any successor regulations74 7,b7 ,! ,secret>y may1 bas$ on program implem5tation exp]i5ce or o!r factors f\nd appropriate by ! ,secret>y1 *>act]ize any ,,otc monograph ord] reque/ z a ,ti] #b ,,otc monograph ord] reque/ 7includ+ re*>act]iz+ a reque/ f ,ti] #a to ,ti] #b7 & publi% su* det]m9ation 9 a propos$ ord] issu$ pursuant to section #eje;,g4 7#aj7 7,a7 ,! t]m ,,otc monograph drug facility means a =eign or dome/ic bus9ess or o!r entity t-- 7i7 is-- 7,i7 "u "o managem5t1 ei!r direct or indirect2 & 7,,ii7 at "o geographic location or address engag$ 9 manufactur+ or process+ ! f9i%$ dosage =m ( an ,,otc monograph drug2 7ii7 includes a f9i%$ dosage =m manufactur] facility 9 a contractual relation%ip ) ! sponsor ( "o or m ,,otc monograph drugs to manufacture or process su* drugs2 & 7iii7 does n include a bus9ess or o!r entity ^: only manufactur+ or process+ activities are "o or m ( ! foll[+3 production ( cl9ical rese>* supplies1 te/+1 or placem5t ( out] packag+ on packages conta9+ multiple products1 = su* purposes z creat+ multipacks1 :5 ea* monograph drug product conta9$ )9 ! ov]packag+ is already 9 a f9al packag$ =m prior to placem5t 9 ! out] ov]packag+4 7,b7 ,= purposes ( subp>agraph 7,a77i77,,ii71 sep>ate build+s or locations )9 close proximity are consid]$ to be at "o geographic location or address if ! activities conduct$ 9 su* build+s or locations are-- 7i7 closely relat$ to ! same bus9ess ent]prise2 7ii7 "u ! sup]vision ( ! same local managem5t2 & 7iii7 "u a s+le ,,fda e/abli%m5t id5tifi] & capable ( be+ inspect$ by ! ,food & ,drug ,adm9i/ration dur+ a s+le inspection4 7,c7 ,if a bus9ess or o!r entity w\ld meet crit]ia specifi$ 9 subp>agraph 7,a71 b = be+ "u multiple managem5t1 ! bus9ess or o!r entity is deem$ to con/itute multiple facilities1 "o p] managem5t entity1 = purposes ( ?is p>agraph4 7#aa7 ,! t]m ,,otc monograph drug meet+ means any meet+ reg>d+ ! cont5t ( a propos$ ,,otc monograph ord] reque/4 7#ab7 ,! t]m p]son includes an affiliate ( a p]son4 7#ac7 ,! t]ms reque/or & sponsor h ! mean+s giv5 su* t]ms 9 section #eje;,g4 #gdd,m4 ,au?ority to assess & use ,,otc monograph fees 7a7 ,types ( fees ,beg9n+ ) fiscal ye> #bjba1 ! ,secret>y %all assess & collect fees 9 accordance ) ?is section z foll[s3 7#a7 ,facility fee 7,a7 ,9 g5]al ,ea* p]son t owns a facility id5tifi$ z an ,,otc monograph drug facility on ,decemb] #ca ( ! fiscal ye> or at any "t dur+ ! prec$+ #ab-mon? p]iod %all be assess$ an annual fee = ea* su* facility z det]m9$ "u subsection 7c74 7,b7 ,exceptions 7i7 ,facilities t cease activities ,a fee %all n be assess$ "u subp>agraph 7,a7 if ! id5tifi$ ,,otc monograph drug facility-- 7,i7 has ceas$ all activities relat$ to ,,otc monograph drugs prior to ,decemb] #ca ( ! ye> imm$iately prec$+ ! applicable fiscal ye>2 & 7,,ii7 has updat$ its regi/ration to reflect su* *ange "u ! requirem5ts = drug e/abli%m5t regi/ration set =? 9 section #eaj4 7ii7 ,contract manufactur+ organizations ,! am\nt ( ! fee = a contract manufactur+ organization facility %all be equal to two-?irds ( ! am\nt ( ! fee = an ,,otc monograph drug facility t is n a contract manufactur+ organization facility4 7,c7 ,am\nt ,! am\nt ( fees e/abli%$ "u subp>agraph 7,a7 %all be e/abli%$ "u subsection 7c74 7,d7 ,due date 7i7 ,= fir/ program ye> ,= fiscal ye> #bjba1 ! facility fees requir$ "u subp>agraph 7,a7 %all be due on ! lat] (-- 7,i7 ! fir/ bus9ess day ( ,june ( #bjbj2 or 7,,ii7 #de cal5d> days aft] publication ( ! ,f$]al ,regi/] notice provid$ = "u subsection 7c77#d77;,a74 7ii7 ,subsequ5t fiscal ye>s ,= ea* fiscal ye> aft] fiscal ye> #bjba1 ! facility fees requir$ "u subp>agraph 7,a7 %all be due on ! lat] (-- 7,i7 ! fir/ bus9ess day ( ,june ( su* ye>2 or 7,,ii7 ! fir/ bus9ess day aft] ! enactm5t ( an appropriations ,act provid+ = ! collection & obligation ( fees "u ?is section = su* ye>4 7#b7 ,,otc monograph ord] reque/ fee 7,a7 ,9 g5]al ,ea* p]son t submits an ,,otc monograph ord] reque/ %all be subject to a fee = an ,,otc monograph ord] reque/4 ,! am\nt ( su* fee %all be-- 7i7 = a ,ti] #a ,,otc monograph ord] reque/1 #ejj1jjj1 adju/$ = inflation = ! fiscal ye> 7z det]m9$ "u subsection 7c77#a77;,b772 & 7ii7 = a ,ti] #b ,,otc monograph ord] reque/1 #ajj1jjj1 adju/$ = inflation = ! fiscal ye> 7z det]m9$ "u subsection 7c77#a77;,b774 7,b7 ,due date ,! ,,otc monograph ord] reque/ fees requir$ "u subp>agraph 7,a7 %all be due on ! date ( submission ( ! ,,otc monograph ord] reque/4 7,c7 ,exception = c]ta9 safety *anges ,a p]son :o is nam$ z ! reque/or 9 an ,,otc monograph ord] %all n be subject to a fee "u subp>agraph 7,a7 if ! ,secret>y f9ds t ! ,,otc monograph ord] reque/ seeks to *ange ! drug facts label+ ( an ,,otc monograph drug 9 a way t w\ld add to or /r5g!n-- 7i7 a contra9dication1 w>n+1 or precaution2 7ii7 a /atem5t ab\t risk associat$ ) misuse or abuse2 or 7iii7 an in/ruction ab\t dosage & adm9i/ration t is int5d$ to increase ! safe use ( ! ,,otc monograph drug4 7,d7 ,refund ( fee if ord] reque/ is recategoriz$ z a ,ti] #b ,,otc monograph ord] reque/ ,if ! ,secret>y det]m9es t an ,,otc monograph reque/ initially *>act]iz$ z ,ti] #a %all be re-*>act]iz$ z a ,ti] #b ,,otc monograph ord] reque/1 & ! reque/or has paid a ,ti] #a fee 9 accordance ) subp>agraph 7,a77i71 ! ,secret>y %all refund ! reque/or ! diff]5ce betwe5 ! ,ti] #a & ,ti] #b fees det]m9$ "u subp>agraphs 7,a77i7 & 7,a77ii71 respectively4 7,e7 ,refund ( fee if ord] reque/ refus$ = fil+ or )drawn be=e fil+ ,! ,secret>y %all refund #ge p]c5t ( ! fee paid "u subp>agraph 7,b7 = any ord] reque/ :i* is refus$ = fil+ or 0 )drawn be=e be+ accept$ or refus$ = fil+4 7,f7 ,fees = ord] reque/s previ\sly refus$ = fil+ or )drawn be=e fil+ ,an ,,otc monograph ord] reque/ t 0 submitt$ b 0 refus$ = fil+1 or 0 )drawn be=e be+ accept$ or refus$ = fil+1 %all be subject to ! full fee "u subp>agraph 7,a7 ^u be+ resubmitt$ or fil$ ov] prote/4 7,g7 ,refund ( fee if ord] reque/ )drawn ,if an ord] reque/ is )drawn aft] ! ord] reque/ 0 fil$1 ! ,secret>y may refund ! fee or a portion ( ! fee if no sub/antial "w 0 p]=m$ on ! ord] reque/ aft] ! application 0 fil$4 ,! ,secret>y %all h ! sole discretion to refund a fee or a portion ( ! fee "u ?is subp>agraph4 ,a det]m9ation by ! ,secret>y conc]n+ a refund "u ?is subp>agraph %all n be reviewable4 7#c7 ,refunds 7,a7 ,9 g5]al ,o!r ?an refunds provid$ pursuant to any ( subp>agraphs 7,d7 ?r\gh 7,g7 ( p>agraph 7#b71 ! ,secret>y %all n refund any fee paid "u p>agraph 7#a7 except z provid$ 9 subp>agraph 7,b74 7,b7 ,disputes conc]n+ fees ,to qualify = ! return ( a fee claim$ to h be5 paid 9 error "u p>agraph 7#a7 or 7#b71 a p]son %all submit to ! ,secret>y a writt5 reque/ ju/ify+ su* return )9 #ahj cal5d> days aft] su* fee 0 paid4 7#d7 ,notice ,)9 ! timeframe specifi$ 9 subsection 7c71 ! ,secret>y %all publi% 9 ! ,f$]al ,regi/] ! am\nt ( ! fees "u p>agraph 7#a7 = su* fiscal ye>4 7b7 ,fee rev5ue am\nts 7#a7 ,fiscal ye> #bjba ,= fiscal ye> #bjba1 fees "u subsection 7a77#a7 %all be e/abli%$ to g5]ate a total facility fee rev5ue am\nt equal to ! sum (-- 7,a7 ! annual base rev5ue = fiscal ye> #bjba 7z det]m9$ "u p>agraph 7#c772 7,b7 ! doll> am\nt equal to ! op]at+ res]ve adju/m5t = ! fiscal ye>1 if applicable 7z det]m9$ "u subsection 7c77#b772 & 7,c7 additional direct co/ adju/m5ts 7z det]m9$ "u subsection 7c77#c774 7#b7 ,subsequ5t fiscal ye>s ,= ea* ( ! fiscal ye>s #bjbb ?r\gh #bjbe1 fees "u subsection 7a77#a7 %all be e/abli%$ to g5]ate a total facility fee rev5ue am\nt equal to ! sum (-- 7,a7 ! annual base rev5ue = ! fiscal ye> 7z det]m9$ "u p>agraph 7#c772 7,b7 ! doll> am\nt equal to ! inflation adju/m5t = ! fiscal ye> 7z det]m9$ "u subsection 7c77#a772 7,c7 ! doll> am\nt equal to ! op]at+ res]ve adju/m5t = ! fiscal ye>1 if applicable 7z det]m9$ "u subsection 7c77#b772 7,d7 additional direct co/ adju/m5ts 7z det]m9$ "u subsection 7c77#c772 & 7,e7 additional doll> am\nts = ea* fiscal ye> z foll[s3 7i7 #g1jjj1jjj = fiscal ye> #bjbb4 7ii7 #f1jjj1jjj = fiscal ye> #bjbc4 7iii7 #g1jjj1jjj = fiscal ye> #bjbd4 7iv7 #c1jjj1jjj = fiscal ye> #bjbe4 7#c7 ,annual base rev5ue ,= purposes ( p>agraphs 7#a77;,a7 & 7#b77;,a71 ! doll> am\nt ( ! annual base rev5ue = a fiscal ye> %all be-- 7,a7 = fiscal ye> #bjba1 #h1jjj1jjj2 & 7,b7 = fiscal ye>s #bjbb ?r\gh #bjbe1 ! doll> am\nt ( ! total rev5ue am\nt e/abli%$ "u ?is subsection = ! previ\s fiscal ye>1 n includ+ any adju/m5ts made "u subsection 7c77#b7 or 7c77#c74 7c7 ,adju/m5ts2 annual fee sett+ 7#a7 ,inflation adju/m5t 7,a7 ,9 g5]al ,= purposes ( subsection 7b77#b77;,b71 ! doll> am\nt ( ! inflation adju/m5t to ! annual base rev5ue = fiscal ye> #bjbb & ea* subsequ5t fiscal ye> %all be equal to ! product (-- 7i7 su* annual base rev5ue = ! fiscal ye> "u subsection 7b77#b72 & 7ii7 ! inflation adju/m5t p]c5tage "u subp>agraph 7,c74 7,b7 ,,otc monograph ord] reque/ fees ,= purposes ( subsection 7a77#b71 ! doll> am\nt ( ! inflation adju/m5t to ! fee = ,,otc monograph ord] reque/s = fiscal ye> #bjbb & ea* subsequ5t fiscal ye> %all be equal to ! product (-- 7i7 ! applicable fee "u subsection 7a77#b7 = ! prec$+ fiscal ye>2 & 7ii7 ! inflation adju/m5t p]c5tage "u subp>agraph 7,c74 7,c7 ,inflation adju/m5t p]c5tage ,! inflation adju/m5t p]c5tage "u ?is subp>agraph = a fiscal ye> is equal to-- 7i7 = ea* ( fiscal ye>s #bjbb & #bjbc1 ! av]age annual p]c5t *ange t occurr$ 9 ! ,consum] ,price ,index = urban consum]s 7,wa%+ton-,baltimore1 ,,dc-,,md-,,va-,,wv2 ,n ,seasonally ,adju/$2 ,all items2 ,annual ,index7 = ! fir/ #c ye>s ( ! prec$+ #d ye>s ( available data2 & 7ii7 = ea* ( fiscal ye>s #bjbd & #bjbe1 ! sum (-- 7,i7 ! 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 ye>s ( ! prec$+ #d fiscal ye>s1 multipli$ by ! proportion ( p]sonnel comp5sation & b5efits co/s to total co/s ( ,,otc monograph drug activities = ! fir/ #c ye>s ( ! prec$+ #d fiscal ye>s2 & 7,,ii7 ! av]age annual p]c5t *ange t occurr$ 9 ! ,consum] ,price ,index = urban consum]s 7,wa%+ton-,baltimore1 ,,dc-,,md-,,va-,,wv2 ,n ,seasonally ,adju/$2 ,all items2 ,annual ,index7 = ! fir/ #c ye>s ( ! prec$+ #d ye>s ( available data multipli$ by ! proportion ( all co/s o!r ?an p]sonnel comp5sation & b5efits co/s to total co/s ( ,,otc monograph drug activities = ! fir/ #c ye>s ( ! prec$+ #d fiscal ye>s4 7#b7 ,op]at+ res]ve adju/m5t 7,a7 ,9 g5]al ,= fiscal ye> #bjba & subsequ5t fiscal ye>s1 = purposes ( subsections 7b77#a77;,b7 & 7b77#b77;,c71 ! ,secret>y may1 9 addition to adju/m5ts "u p>agraph 7#a71 fur!r increase ! fee rev5ue & fees if su* an adju/m5t is necess>y to provide op]at+ res]ves ( c>ryov] us] fees = ,,otc monograph drug activities = n m ?an ! numb] ( weeks specifi$ 9 subp>agraph 7,b74 7,b7 ,numb] ( weeks ,! numb] ( weeks specifi$ 9 ?is subp>agraph is-- 7i7 #c weeks = fiscal ye> #bjba2 7ii7 #g weeks = fiscal ye> #bjbb2 7iii7 #aj weeks = fiscal ye> #bjbc2 7iv7 #aj weeks = fiscal ye> #bjbd2 & 7v7 #aj weeks = fiscal ye> #bjbe4 7,c7 ,decrease ,if ! ,secret>y has c>ryov] balances = su* process 9 excess ( #aj weeks ( ! op]at+ res]ves ref]r$ to 9 subp>agraph 7,a71 ! ,secret>y %all decrease ! fee rev5ue & fees ref]r$ to 9 su* subp>agraph to provide = n m ?an #aj weeks ( su* op]at+ res]ves4 7,d7 ,rationale = adju/m5t ,if an adju/m5t "u ?is p>agraph is made1 ! rationale = ! am\nt ( ! increase or decrease 7z applicable7 9 fee rev5ue & fees %all be conta9$ 9 ! annual ,f$]al ,regi/] notice "u p>agraph 7#d7 e/abli%+ fee rev5ue & fees = ! fiscal ye> involv$4 7#c7 ,additional direct co/ adju/m5t ,! ,secret>y %all1 9 addition to adju/m5ts "u p>agraphs 7#a7 & 7#b71 fur!r increase ! fee rev5ue & fees = purposes ( subsection 7b77#b77;,d7 by an am\nt equal to-- 7,a7 #ad1jjj1jjj = fiscal ye> #bjba2 7,b7 #g1jjj1jjj = fiscal ye> #bjbb2 7,c7 #d1jjj1jjj = fiscal ye> #bjbc2 7,d7 #c1jjj1jjj = fiscal ye> #bjbd2 & 7,e7 #c1jjj1jjj = fiscal ye> #bjbe4 7#d7 ,annual fee sett+ 7,a7 ,fiscal ye> #bjba ,! ,secret>y %all1 n lat] ?an ! second ,monday 9 ,m>* ( #bjbj-- 7i7 e/abli% ,,otc monograph drug facility fees = fiscal ye> #bjba "u subsection 7a71 bas$ on ! rev5ue am\nt = su* ye> "u subsection 7b7 & ! adju/m5ts provid$ "u ?is subsection2 & 7ii7 publi% fee rev5ue1 facility fees1 & ,,otc monograph ord] reque/s 9 ! ,f$]al ,regi/]4 7,b7 ,subsequ5t fiscal ye>s ,! ,secret>y %all1 = ea* fiscal ye> t beg9s aft] ,septemb] #cj1 #bjba1 n lat] ?an ! second ,monday 9 ,m>* t prec$es su* fiscal ye>-- 7i7 e/abli% = su* fiscal ye>1 bas$ on ! rev5ue am\nts "u subsection 7b7 & ! adju/m5ts provid$ "u ?is subsection-- 7,i7 ,,otc monograph drug facility fees "u subsection 7a77#a72 & 7,,ii7 ,,otc monograph ord] reque/ fees "u subsection 7a77#b72 & 7ii7 publi% su* fee rev5ue am\nts1 facility fees1 & ,,otc monograph ord] reque/ fees 9 ! ,f$]al ,regi/]4 7d7 ,id5tification ( facilities ,ea* p]son t owns an ,,otc monograph drug facility %all submit to ! ,secret>y ! in=mation requir$ "u ?is subsection ea* ye>4 ,su* in=mation %all1 = ea* fiscal ye>-- 7#a7 be submitt$ z "p ( ! requirem5ts = drug e/abli%m5t regi/ration set =? 9 section #eaj2 & 7#b7 include = ea* su* facility1 at a m9imum1 id5tification ( ! facility's bus9ess op]ation z t ( an ,,otc monograph drug facility4 7e7 ,effect ( failure ,to pay fees 7#a7 ,,otc ,monograph ,drug ,facility ,fee 7,a7 ,9 g5]al ,failure to pay ! fee "u subsection 7a77#a7 )9 #bj cal5d> days ( ! due date z specifi$ 9 subp>agraph 7,d7 ( su* subsection %all result 9 ! foll[+3 7i7 ,! ,secret>y %all place ! facility on a publicly available arre>s li/4 7ii7 ,all ,,otc monograph drugs manufactur$ 9 su* a facility or conta9+ an +r$i5t manufactur$ 9 su* a facility %all be deem$ misbr&$ "u section #ejb7;ff74 7,b7 ,application ( p5alties ,! p5alties "u ?is p>agraph %all apply until ! fee e/abli%$ by subsection 7a77#a7 is paid4 7#b7 ,ord] reque/s ,an ,,otc monograph ord] reque/ submitt$ by a p]son subject to fees "u subsection 7a7 %all be consid]$ incomplete & %all n be accept$ = fil+ by ! ,secret>y until all fees ow$ by su* p]son "u ?is section h be5 paid4 7#c7 ,meet+s ,a p]son subject to fees "u ?is section %all be consid]$ ineligible = ,,otc monograph drug meet+s until all su* fees ow$ by su* p]son h be5 paid4 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 = ,,otc monograph drug activities4 7#b7 ,collections & appropriation ,acts 7,a7 ,9 g5]al ,subject to subp>agraph 7,c71 ! 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 = obligation1 = su* fiscal ye>4 7,b7 ,use ( fees & limitation ,! fees au?oriz$ by ?is section %all be available to defray increases 9 ! co/s ( ! res\rces allocat$ = ,,otc monograph drug activities 7includ+ increases 9 su* co/s = an additional numb] ( full-"t equival5t positions 9 ! ,dep>tm5t ( ,heal? & ,human ,s]vices to be engag$ 9 su* activities71 only if ! ,secret>y allocates = su* purpose an am\nt = su* fiscal ye> 7exclud+ am\nts f fees collect$ "u ?is section7 no less ?an #ab1jjj1jjj1 multipli$ by ! adju/m5t factor applicable to ! fiscal ye> involv$ "u subsection 7c77#a74 7,c7 ,compliance ,! ,secret>y %all be consid]$ to h met ! requirem5ts ( subp>agraph 7,b7 9 any fiscal ye> if ! co/s fund$ by appropriations & allocat$ = ,,otc monograph drug activities are n m ?an #ae p]c5t bel[ ! level specifi$ 9 su* subp>agraph4 7,d7 ,provision = e>ly paym5ts 9 subsequ5t ye>s ,paym5t ( fees au?oriz$ "u ?is section = a fiscal ye> 7aft] fiscal ye> #bjba71 prior to ! due date = su* fees1 may be accept$ by ! ,secret>y 9 accordance ) au?ority provid$ 9 advance 9 a prior ye> appropriations ,act4 7#c7 ,au?orization ( appropriations ,= ea* ( ! fiscal ye>s #bjba ?r\gh #bjbe1 !re is au?oriz$ to be appropriat$ = fees "u ?is section an am\nt equal to ! total am\nt ( fees assess$ = su* fiscal ye> "u ?is section4 7g7 ,collection ( unpaid fees ,9 any case :]e ! ,secret>y does n receive paym5t ( a fee assess$ "u subsection 7a7 )9 #cj cal5d> days aft] x is due1 su* fee %all be treat$ z a claim ( ! ,unit$ ,/ates ,gov]nm5t subject to sub*apt] ,,ii ( *apt] #cg ( title #ca1 ,unit$ ,/ates ,code4 7h7 ,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 employ]s1 & advisory committees n engag$ 9 ,,otc monograph drug activities1 be r$uc$ to (fset ! numb] ( (fic]s1 employees1 & advisory committees s engag$4 #gdd,n4 ,reau?orization2 report+ requirem5ts 7a7 ,p]=mance report ,beg9n+ ) fiscal ye> #bjba1 & n lat] ?an #abj cal5d> days aft] ! end ( ea* fiscal ye> !reaft] = :i* fees are collect$ "u ?is "p1 ! ,secret>y %all prep>e & submit to ! ,committee on ,en]gy & ,comm]ce ( ! ,h\se ( ,repres5tatives & ! ,committee on ,heal?1 ,education1 ,labor1 & ,p5sions ( ! ,s5ate a report conc]n+ ! progress ( ! ,food & ,drug ,adm9i/ration 9 a*iev+ ! goals id5tifi$ 9 ! lett]s describ$ 9 section #bja7;b7 ( ! ,ov]-!-,c\nt] ,monograph ,safety1 ,innovation1 & ,re=m ,act ( #bjai dur+ su* fiscal ye> & ! future plans ( ! ,food & ,drug ,adm9i/ration = meet+ su* goals4 7b7 ,fiscal report ,n lat] ?an #abj cal5d> days aft] ! end ( fiscal ye> #bjba & ea* subsequ5t fiscal ye> = :i* fees are collect$ "u ?is "p1 ! ,secret>y %all prep>e & submit to ! ,committee on ,en]gy & ,comm]ce ( ! ,h\se ( ,repres5tatives & ! ,committee on ,heal?1 ,education1 ,labor1 & ,p5sions ( ! ,s5ate a report on ! implem5tation ( ! au?ority = su* fees dur+ su* fiscal ye> & ! use1 by ! ,food & ,drug ,adm9i/ration1 ( ! fees collect$ = su* fiscal ye>4 7c7 ,public availability ,! ,secret>y %all make ! reports requir$ "u subsections 7a7 & 7b7 available to ! public on ! int]net website ( ! ,food & ,drug ,adm9i/ration4 7d7 ,reau?orization 7#a7 ,consultation ,9 develop+ recomm5dations to pres5t to ! ,congress ) respect to ! goals describ$ 9 subsection 7a71 & plans = meet+ ! goals1 = ,,otc monograph drug activities = ! fir/ #e fiscal ye>s aft] fiscal ye> #bjbe1 & = ! reau?orization ( ?is "p = su* fiscal ye>s1 ! ,secret>y %all consult )-- 7,a7 ! ,committee on ,en]gy & ,comm]ce ( ! ,h\se ( ,repres5tatives2 7,b7 ! ,committee on ,heal?1 ,education1 ,labor1 & ,p5sions ( ! ,s5ate2 7,c7 sci5tific & academic exp]ts2 7,d7 heal? c>e pr(essionals2 7,e7 repres5tatives ( pati5t & consum] advocacy gr\ps2 & 7,f7 ! regulat$ indu/ry4 7#b7 ,public review ( recomm5dations ,aft] negotiations ) ! regulat$ indu/ry1 ! ,secret>y %all-- 7,a7 pres5t ! recomm5dations develop$ "u p>agraph 7#a7 to ! congressional committees specifi$ 9 su* p>agraph2 7,b7 publi% su* recomm5dations 9 ! ,f$]al ,regi/]2 7,c7 provide = a p]iod ( #cj cal5d> days = ! public to provide writt5 comm5ts on su* recomm5dations2 7,d7 hold a meet+ at :i* ! public may pres5t its views on su* recomm5dations2 & 7,e7 aft] consid]ation ( su* public views & comm5ts1 revise su* recomm5dations z necess>y4 7#c7 ,transmittal ( recomm5dations ,n lat] ?an ,janu>y #ae1 #bjbe1 ! ,secret>y %all transmit to ! ,congress ! revis$ recomm5dations "u p>agraph 7#b71 a summ>y ( ! views & comm5ts receiv$ "u su* p>agraph1 & any *anges made to ! recomm5dations 9 response to su* views & comm5ts4 4 ,pass$ ! ,s5ate ,decemb] #aj1 #bjai4,secret>y