,,ii #aae? ,,congress #b;d ,session ,s4 #bcae ,,9 ,,! ,,s5ate ,,( ,,! ,,unit$ ,,/ates ,janu>y #ag1 #bjah,mr4 ,isakson 7= himself & ,mr4 ,casey7 introduc$ ! foll[+ bill2 :i* 0 read twice & ref]r$ to ! ,committee on ,heal?1 ,education1 ,labor1 & ,p5sions ,a ,,bill ,to am5d ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act to cl>ify ! regulatory framework ) respect to c]ta9 nonprescription drugs t are m>ket$ )\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] ,drug ,safety1 ,innovation1 & ,re=m ,act4 7b7 ,table ( cont5ts ,! table ( cont5ts = ?is ,act is z foll[s3 ,sec4 #a4 ,%ort title2 table ( cont5ts4,,title ,i--,regulation ( nonprescription drugs,sec4 #aja4 ,regulation ( c]ta9 nonprescription drugs t are m>ket$ )\t an approv$ new drug application4,sec4 #ajb4 ,misbr&+4,sec4 #ajc4 ,con=m+ am5dm5ts to ! ,sunscre5 ,innovation ,act4,sec4 #ajd4 ,drugs exclud$ f ov]-!-c\nt] review4,sec4 #aje4 ,con=m+ am5dm5t4,sec4 #ajf4 ,annual update to ,congress on appropriate p$iatric indication = c]ta9 c\gh & cold monograph drugs4,,title ,,ii--,fees relat+ to monograph drugs,sec4 #bja4 ,%ort title2 f9d+s4,sec4 #bjb4 ,au?ority to access & use fees4 ,i ,regulation ( nonprescription drugs #aja4 ,regulation ( c]ta9 nonprescription drugs t are m>ket$ )\t an approv$ new drug application ,*apt] ,v ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act is am5d$ by ins]t+ aft] section #eje;,f 7#ba ,u4,s4,c4 #cee;g7 ! foll[+3 #eje;,g4 ,regulation ( c]ta9 nonprescription drugs t are m>ket$ )\t an approv$ new drug application 7a7 ,def9itions ,9 ?is section3 7#a7 ,nonprescription drug ,! t]m nonprescription drug means a drug1 an active +r$i5t1 or a comb9ation ( active +r$i5ts t is n subject to section #ejc7;b77#a74 7#b7 ,reque/or ,! t]m reque/or means a p]son or gr\p ( p]sons m>ket+1 manufactur+1 process+1 or develop+ a drug4 7#c7 ,sponsor ,! t]m sponsor means a p]son or gr\p ( p]sons m>ket+1 manufactur+1 or process+ a drug & :o has a li/+ 9 effect "u section #eaj7;j7 = su* drug4 7b7 ,monograph drugs 7#a7 ,9 g5]al ,) respect to a nonprescription drug t1 on or aft] ! date ( enactm5t ( ! ,ov]-!-,c\nt] ,drug ,safety1 ,innovation1 & ,re=m ,act1 is introduc$ or deliv]$ = introduction 9 int]/ate comm]ce = :i* an approv$ application "u section #eje is n requir$1 ! foll[+ %all apply3 7,a7 ,a nonprescription drug is deem$ to be g5]ally recogniz$ z safe & effective )9 ! mean+ ( section #bja7p77#a7 & n a new drug "u section #bja7p7 if-- 7i7 7,i7 su* drug is-- 7aa7 7,,aa7 subject to a f9al monograph issu$ "u "p #ccj ( title #ba1 ,code ( ,f$]al ,regulations1 z ( ! date ( enactm5t ( ! ,ov]-!-,c\nt] ,drug ,safety1 ,innovation1 & ,re=m ,act2 7,,bb7 9 con=mity ) ! conditions = nonprescription use ( su* monograph & ! g5]al requirem5ts specifi$ = nonprescription drugs1 includ+ any modifications to ^? conditions made "u subsections 7c71 7d71 & 7j72 & 7,,cc7 except z p]mitt$ by an adm9i/rative ord] issu$ "u subsection 7c7 or a m9or *ange 9 ! drug 9 con=mity ) subsection 7d71 is 9 a dosage =m t has be5 us$ to a mat]ial ext5t & = a mat]ial "t )9 ! mean+ ( section #bja7p77#b72 or 7bb7 7,,aa7 ! subject ( a t5tative f9al monograph t is ! mo/ rec5tly applicable proposal or det]m9ation issu$ "u "p #ccj ( title #ba1 ,code ( ,f$]al ,regulations1 z ( ! date ( enactm5t ( ! ,ov]-!-,c\nt] ,drug ,safety1 ,innovation1 & ,re=m ,act2 7,,bb7 classifi$ 9 category ,i = safety & effectiv5ess "u su* t5tative f9al monograph2 7,,cc7 9 con=mity ) ! conditions = nonprescription use ( su* t5tative f9al monograph1 any subsequ5t det]m9ation by ! ,secret>y1 & ! g5]al conditions = nonprescription drugs1 includ+ any modifications ( ^? conditions "u subsections 7c71 7d71 & 7j72 & 7,,dd7 except z p]mitt$ by an adm9i/rative ord] issu$ "u subsection 7c7 or a m9or *ange 9 ! drug 9 con=mity ) subsection 7d71 is 9 a dosage =m t has be5 us$ to a mat]ial ext5t & = a mat]ial "t )9 ! mean+ ( section #bja7p77#b72 or 7,,ii7 ! active +r$i5t 9 su* drug is 9 con=mity )-- 7aa7 ! requirem5ts ( a f9al adm9i/rative ord] issu$ "u subsection 7c7 det]m9+ t su* drug "u ! specific conditions ( use is g5]ally recogniz$ z safe & effective )9 ! mean+ ( section #bja7p77#a72 & 7bb7 ! g5]al requirem5ts = nonprescription drugs1 includ+ any modifications ( ! requirem5ts "u subsections 7c71 7d71 & 7j72 & 7ii7 su* drug is-- 7,i7 n classifi$ 9 ,category ,,ii = safety or effectiv5ess "u a t5tative f9al monograph2 or 7,,ii7 det]m9$ by ! ,secret>y to be n safe & effective1 9 a f9al monograph or preamble to a rule t is ! mo/ rec5tly applicable proposal or det]m9ation issu$ "u "p #ccj ( title #ba1 ,code ( ,f$]al ,regulations4 7,b7 ,a nonprescription drug may be introduc$ into int]/ate comm]ce if su* drug is-- 7i7 7,i7 n classifi$ 9 ,category ,,ii = safety or effectiv5ess "u a t5tative f9al monograph2 or 7,,ii7 det]m9$ by ! ,secret>y to be n safe & effective1 9 a f9al monograph or preamble to a rule t is ! mo/ rec5tly applicable proposal or det]m9ation issu$ "u "p #ccj ( title #ba1 ,code ( ,f$]al ,regulations2 & 7ii7 7,i7 7aa7 ! subject ( a t5tative f9al monograph t is ! mo/ rec5tly applicable proposal or det]m9ation issu$ "u "p #ccj ( title #ba1 ,code ( ,f$]al ,regulations2 7bb7 classifi$ 9 category ,,iii = safety or effectiv5ess 9 ! preamble ( a propos$ rule e/abli%+ su* t5tative f9al monograph2 7cc7 9 con=mity ) ! mo/ rec5tly propos$ or f9al rule e/abli%+ or propos+ conditions ( nonprescription use publi%$ 9 ! ,f$]al ,regi/] relat$ to su* t5tative f9al monograph & ! g5]al requirem5ts = nonprescription drugs1 includ+ any modifications ( ^? requirem5ts "u subsections 7c7 & 7j72 & 7dd7 9 a dosage =m t has be5 us$ to a mat]ial ext5t & = a mat]ial "t )9 ! mean+ ( section #bja7p77#b72 or 7,,ii7 7aa7 ! subject ( a propos$ monograph or advance notice ( propos$ rulemak+ t is ! mo/ rec5tly applicable proposal or det]m9ation issu$ "u "p #ccj ( title #ba1 ,code ( ,f$]al ,regulations2 7bb7 classifi$ 9 category ,i = safety & effectiv5ess "u su* propos$ monograph or advance notice ( propos$ rulemak+2 7cc7 9 con=mity ) ! mo/ rec5tly propos$ or f9al rule e/abli%+ or propos+ conditions ( nonprescription use publi%$ 9 ! ,f$]al ,regi/] relat$ to su* propos$ monograph or advance notice ( propos$ rulemak+ & ! g5]al requirem5ts = nonprescription drugs1 includ+ any modifications ( ^? requirem5ts "u subsections 7c7 & 7j72 & 7dd7 9 a dosage =m t has be5 us$ to a mat]ial ext5t & = a mat]ial "t )9 ! mean+ ( section #bja7p77#b74 7,c7 ,a nonprescription drug may be introduc$ into int]/ate comm]ce if-- 7i7 su* drug is classifi$ 9 category ,,ii = safety or effectiv5ess "u a t5tative f9al monograph1 or ! ,secret>y has det]m9$ su* drug n to be safe & effective 9 a f9al monograph or preamble to a rule t is ! mo/ rec5tly applicable proposal or det]m9ation issu$ "u "p #ccj ( title #ba1 ,code ( ,f$]al ,regulations2 & 7ii7 ! ,secret>y det]m9es )9 #f mon?s ( ! date ( enactm5t ( ! ,ov]-!-,c\nt] ,drug ,safety1 ,innovation1 & ,re=m ,act1 t x is 9 ! int]e/ ( public heal? to ext5d ! p]iod dur+ :i* ! drug may be m>ket$ )\t an approv$ new drug application "u section #eje4 7,d7 ,a drug t is subject to ! f9al monograph = sunscre5 drug products set =? at "p #ceb ( title #ba1 ,code ( ,f$]al ,regulations 7z publi%$ at volume #fd page #bgfhg ( ! ,f$]al ,regi/]71 %all comply ) ! requirem5ts ( t monograph1 except t ! te/+ requirem5ts = effectiv5ess & ! provisions gov]n+ label+ %all be 9 accordance ) section #bja4cbg ( title #ba1 ,code ( ,f$]al ,regulations 7z 9 effect on ! date ( enactm5t ( ! ,ov]-!-,c\nt] ,drug ,safety1 ,innovation1 & ,re=m ,act71 or su* *anges to ^? requirem5ts z may be made "u subsections 7c71 7d71 & 7j74 7#b7 ,new drugs ,a nonprescription drug is a new drug )9 ! mean+ ( section #bja7p7 & subject to ! requirem5ts ( section #eje if ! drug is-- 7,a7 n describ$ 9 subp>agraph 7,a71 7,b71 or 7,d7 ( p>agraph 7#a7 & n 9 con=mity ) subsection 7d72 7,b7 n subject to an adm9i/rative f9al ord] pursuant to subsection 7c72 or 7,c7 n a nonprescription sunscre5 active +r$i5t or comb9ation ( +r$i5ts subject to a f9al sunscre5 ord]1 z def9$ 9 section #ehf7b74 7#c7 ,monograph drug ,a nonprescription drug t is 9 compliance ) p>agraph 7#a7 %all be ref]r$ to 9 ?is section z a monograph drug4 7#d7 ,rules ( con/ruction 7,a7 ,9 g5]al ,?is section %all n affect ! treatm5t or /atus ( a nonprescription drug subject to section #eje-- 7i7 t1 on ! date ( enactm5t ( ! ,ov]-!-,c\nt] ,drug ,safety1 ,innovation1 & ,re=m ,act1 is m>ket$ )\t an application approv$ "u section #eje2 & 7ii7 to :i* subp>agraphs 7,a71 7,b71 7,c71 & 7,d7 ( p>agraph 7#a7 d n apply4 7,b7 ,applicability ( o!r provisions ,no?+ 9 ?is p>agraph %all be con/ru$ to preclude or limit ! applicability ( any o!r provision ( ?is ,act4 7,c7 ,no effect on o!r au?orities ,no?+ 9 ?is subsection %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 & effective4 7c7 ,adm9i/rative ord]s 7#a7 ,9 g5]al 7,a7 ,g5]ally recogniz$ z safe & effective ,! ,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 requirem5ts "u :i* a specific drug1 class ( su* drugs1 or comb9ation ( su* drugs is det]m9$ to be1 aft] sub/antive review ( evid5ce-- 7i7 n subject to section #ejc7;b77#a72 7ii7 g5]ally recogniz$ z safe & effective )9 ! mean+ ( section #bja7p77#a72 & 7iii7 n requir$ to be approv$ "u section #eje4 7,b7 ,n g5]ally recogniz$ z safe & effective ,! ,secret>y %all issue an ord] det]m9+ t a drug is n g5]ally recogniz$ z safe & effective )9 ! mean+ ( section #bja7p77#a7 = ! specifi$ requirem5ts if1 aft] sub/antive review ( evid5ce1 ! ,secret>y det]m9es t-- 7i7 ! evid5ce %[s t ! drug is n g5]ally recogniz$ z safe & effective )9 ! mean+ ( section #bja7p77#a72 or 7ii7 ! evid5ce is inadequate to %[ t ! drug is g5]ally recogniz$ z safe & effective )9 ! mean+ ( section #bja7p77#a74 7#b7 ,nonapplication ( c]ta9 requirem5ts ,! requirem5ts ( sub*apt] ,,ii ( *apt] #e ( title #e1 ,unit$ ,/ates ,code1 %all n apply ) respect to adm9i/rative ord]s issu$ "u ?is section4 7#c7 ,adm9i/rative ord]s initiat$ by ! ,secret>y2 citiz5 petitions 7,a7 ,9 g5]al ,except z provid$ 9 p>agraph 7#e71 9 issu+ an adm9i/rative ord] "u p>agraph 7#a7 on ! initiative ( ! ,secret>y1 ! ,secret>y %all-- 7i7 n lat] ?an #b bus9ess days be=e issuance ( ! propos$ ord]1 in=mally communicate ! p5d+ issuance ( ! ord] to sponsors ( drugs t w be subject to su* ord]2 7ii7 aft] mak+ any su* in=mal communication-- 7,i7 issue su* a propos$ adm9i/rative ord] by publi%+ x on ! int]net website ( ! ,food & ,drug ,adm9i/ration & include 9 su* ord] ! reasons = ! issuance ( su* ord]2 & 7,,ii7 publi% 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] satisfy+ ! requirem5ts ( 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 b su* ord] %all n take effect until ! "t = reque/+ judicial review "u p>agraph 7#d77;,d77ii7 has expir$2 7,,ii7 publi% a notice ( availability ( su* f9al adm9i/rative ord] 9 ! ,f$]al ,regi/]2 7,,iii7 af=d reque/ors ( products t w be subject to su* ord] ! opportunity = =mal dispute resolution up to ! level ( ! ,director ( ! ,c5t] = ,drug ,evaluation & ,rese>*1 :i* initially %all 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#d77;,b71 ^u completion ( ! =mal dispute resolution proc$ure1 in=m ! p]son or p]sons :i* s\ght su* dispute resolution ( _! "r to reque/ a he>+4 7,b7 ,special requirem5ts ) respect to c]ta9 monograph drugs ,:5 issu+ an adm9i/rative ord] "u p>agraph 7#a7 on ! initiative ( ! ,secret>y 7except z provid$ "u p>agraph 7#e77 propos+ to det]m9e t a monograph drug describ$ 9 subsection 7b77#a77;,b7 is n g5]ally recogniz$ z safe & effective )9 ! mean+ ( section #bja7p77#a71 ! ,secret>y %all foll[ ! proc$ures 9 subp>agraph 7,a7 except t-- 7i7 ! propos$ 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 )9 ! mean+ ( section #bja7p77#a72 & 7,,ii7 ! =mat = submissions by int]e/$ p]sons2 7ii7 ! ,secret>y %all provide = a public comm5t p]iod ( n 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 )9 ! mean+ ( section #bja7p77#a74 7,c7 ,citiz5 petitions 7i7 ,9 g5]al ,! ,secret>y may issue an adm9i/rative ord] "u p>agraph 7#a7 9 response to a citiz5 petition submitt$ "u section #aj4cj ( title #ba1 ,code ( ,f$]al ,regulations 7or any successor regulation71 subject to clause 7ii74 7ii7 ,effect ( petition ,no?+ 9 clause 7i7 %all be con/ru$ to provide an alt]native to1 or o!rwise supplant or sup]s$e-- 7,i7 ! processes ?r\gh :i* a reque/or may seek an adm9i/rative ord] pursuant to p>agraph 7#f72 or 7,,ii7 ! fee /ructure "u section #gdd,l-#a7;a77#b74 7#d7 ,he>+s2 judicial review 7,a7 ,9 g5]al ,a p]son :o p>ticipat$ 9 ea* level ( =mal dispute resolution "u p>agraph 7#c77;,a77iv77,,iii7 ( an adm9i/rative ord] ) respect to a drug may reque/ a he>+ conc]n+ a f9al adm9i/rative ord] issu$ "u p>agraph 7#c77;,a77iv7 ) respect to su* drug4 ,su* p]son may 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 ,! ,secret>y is n requir$ to provide notice & an opportunity = a he>+ pursuant to p>agraph 7#c77;,a77iv7 if ! f9al adm9i/rative ord] involv$ relates to a drug-- 7i7 t is describ$ 9 subclause 7,i7 or 7,,ii7 ( subsection 7b77#a77;,b77i72 & 7ii7 ) respect to :i* no data relevant to ! safety or effectiv5ess ( su* drug h be5 submitt$ to ! adm9i/rative record s9ce ! issuance ( ! mo/ rec5t t5tative f9al monograph relat+ to su* drug 7or1 z applicable1 s9ce ! deem+ ( su* t5tative f9al monograph z a f9al adm9i/rative ord] "u p>agraph 7#g774 7,c7 ,he>+ proc$ures 7i7 ,d5ial ( reque/ = he>+ ,if ! ,secret>y det]m9es t a reque/ = a he>+ "u subp>agraph 7,a7 ) respect to a f9al adm9i/rative ord] issu$ "u p>agraph 7#c77;,a77iv71 does n e/abli% ! 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] ,! ,secret>y %all appo9t a presid+ (fic] ( a he>+ reque/$ "u subp>agraph 7,a7 :o-- 7,i7 is n an employee ( ! ,c5t] = ,drug ,evaluation & ,rese>*2 & 7,,ii7 has n previ\sly be5 involv$ 9 ! developm5t ( ! applicable adm9i/rative ord] or 9 ! 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 ,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 ,! 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 ,"t 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 a reque/ = su* review n lat] ?an #fj cal5d> days aft] ! late/ (-- 7,i7 ! date on :i* notice ( su* ord] is publi%$2 7,,ii7 ! date on :i* any he>+ ) respect to su* ord] is d5i$ "u subp>agraph 7,c77i72 7,,iii7 ! date on :i* a f9al decision is made foll[+ any he>+ ) respect to su* ord] "u subp>agraph 7,c77v72 or 7,,iv7 if no he>+ is reque/$1 ! date on :i* ! "t = reque/+ a he>+ expires4 7#e7 ,exp$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 monograph drug poses an imm95t haz>d to ! public heal?1 ! ,secret>y may1 aft] in=mally communicat+ ) any sponsor t w be ! subject ( su* det]m9ation1 n lat] ?an #dh h\rs be=e issuance ( an ord] "u ?is subp>agraph-- 7,i7 issue an int]im f9al adm9i/rative ord] = su* drug or comb9ation ( drugs "u p>agraph 7#a71 toge!r ) a detail$ /atem5t ( ! reasons = su* ord]2 7,,ii7 publi% 9 ! ,f$]al ,regi/] a notice ( availability ( su* ord]2 & 7,,iii7 provide = a public comm5t p]iod ( at lea/ #de cal5d> days aft] issuance ( su* int]im f9al ord]4 7ii7 ,nondelegation ,! ,secret>y may n delegate ! au?ority to issue an int]im f9al adm9i/rative ord] "u ?is subp>agraph4 7,b7 ,safety label+ *anges 7i7 ,9 g5]al ,9 ! case ( a det]m9ation by ! ,secret>y t a *ange 9 ! label+ ( a drug1 class ( drugs1 or comb9ation ( drugs subject to ?is section is reasonably expect$ to mitigate a significant or unreasonable risk ( a s]i\s adv]se ev5t associat$ ) use ( ! drug1 ! ,secret>y may1 aft] in=mally communicat+ ) any sponsor t w be ! subject ( su* det]m9ation1 n lat] ?an #dh h\rs be=e issuance ( an ord] "u ?is subp>agraph-- 7,i7 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,,ii7 publi% 9 ! ,f$]al ,regi/] a notice ( availability ( su* ord]2 & 7,,iii7 provide = a public comm5t p]iod ( at lea/ #de cal5d> days aft] issuance ( su* int]im f9al ord]4 7ii7 ,cont5t ( ord] ,an int]im f9al ord] issu$ "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>y1 :i* date1 9 ! case ( an ord] "u subp>agraph 7,b7 t includes *anges to ! packag+ ( ! drug1 %all n be e>li] ?an ! day aft] ! date on :i* ! comm5t p]iod describ$ 9 subp>agraph 7,b77i77,,iii7 ends4 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 ( drugs t w be subject to su* an ord] ! opportunity = =mal dispute resolution up to ! level ( ! ,director ( ! ,c5t] = ,drug ,evaluation & ,rese>*1 :i* initially %all be )9 #de cal5d> days ( ! issuance ( ! ord]2 &1 = subsequ5t levels ( appeal1 )9 #cj cal5d> days ( ! prior decision4 7,e7 ,he>+s 7i7 ,9 g5]al ,a sponsor ( a drug subject to a f9al ord] issu$ "u subp>agraph 7,d7 :o p>ticipat$ 9 ea* level ( =mal dispute resolution "u subp>agraph 7,d77iii7 may reque/ a he>+ on su* ord]4 ,! provisions ( subp>agraphs 7,a71 7,b71 & 7,c7 ( p>agraph 7#d7 %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#c77;,a77iv74 7ii7 ,ref]5ces ,= purposes ( a he>+ "u ?is subp>agraph1 ! ref]5ces 9 subp>agraphs 7,a71 7,b71 & 7,c7 ( p>agraph 7#d7-- 7,i7 to ea* level ( dispute resolution "u p>agraph 7#c77;,a77iv77,,iii7 %all be deem$ to mean ea* level ( =mal dispute resolution "u subp>agraph 7,d77iii72 & 7,,ii7 to f9al adm9i/rative ord] issu$ "u p>agraph 7#c77;,a77iv7 %all be deem$ to mean f9al ord] "u subp>agraph 7,d77i74 7,f7 ,f9al ord] ,n lat] ?an #a ye> aft] ! date on :i* an int]im f9al ord] is issu$ "u subp>agraph 7,a7 or 7,b71 ! ,secret>y %all issue a f9al ord] 9 accordance ) p>agraph 7#a7 & complete any requir$ he>+4 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#d77;,d74 7,h7 ,cl>ification ,p>agraph 7#c7 %all n apply to ! ord]s issu$ "u ?is p>agraph4 7#f7 ,adm9i/rative ord] initiat$ by reque/ 7,a7 ,9 g5]al ,9 issu+ an adm9i/rative ord] "u p>agraph 7#a7 at ! reque/ ( a reque/or or a gr\p ( reque/ors ) 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 subject to subp>agraph 7,d71 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$+s ) respect to issu+ an adm9i/rative ord] 9 accordance ) p>agraphs 7#c7 & 7#d72 & 7iii7 except z provid$ 9 subp>agraph 7,d77v71 if ! ,secret>y det]m9es t a reque/ does n meet ! requirem5ts = fil+ or is n suffici5tly complete or =matt$ to p]mit a sub/antive review1 ! reque/or may elect t ! ,secret>y file ! reque/ ov] prote/1 & ! ,secret>y %all initiate proce$+s to review ! reque/ 9 accordance ) p>agraph 7#c77;,a74 7,b7 ,reque/ to initiate proce$+s 7i7 ,9 g5]al ,a reque/or seek+ an adm9i/rative ord] ) 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 )9 ! mean+ ( 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 or a new condition ( use ( a drug is g5]ally recogniz$ z safe & effective )9 ! mean+ ( section #bja7p77#a71 exempt f section #ejc7;b77#a71 & n requir$ to be ! subject ( an approv$ application "u section #eje1 if su* drug is-- 7aa7 describ$ 9 subsection 7b77#a77;,a72 or 7bb7 describ$ 9 subsection 7b77#a77;,b71 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 )9 ! mean+ ( section #bja7p77#a71 :i* is fil$ by ! ,secret>y "u subp>agraph 7,a77ii77,i74 ,! ,secret>y is n requir$ to complete review ( ! reque/ = a *ange describ$ 9 subclause 7,,ii7 if ! ,secret>y det]m9es1 9 accordance ) subp>agraph 7,d71 t !re is an inadequate basis to f9d ! drug is g5]ally recogniz$ z safe & effective "u p>agraph 7#a7 & issues a f9al ord] ann\nc+ t det]m9ation4 7ii7 ,)drawal ( reque/ ,! reque/or may )draw a reque/ "u ?is p>agraph1 accord+ to ! proc$ures e/abli%$ by ! ,secret>y4 ,not)/&+ any o!r provision ( ?is section1 if su* reque/ is )drawn1 ! ,secret>y %all cease proce$+s "u ?is subp>agraph4 7,c7 ,product diff]5tiation 7i7 ,9 g5]al ,a f9al adm9i/rative ord] issu$ 9 response to a reque/ "u ?is p>agraph %all h ! effect ( provid+ ! ord] reque/or 7or ! lic5sees1 assignees1 or successors 9 int]e/ ( su* reque/or ) respect to ! subject ( su* ord] & li/$ "u clause 7v77 ! exclusive "r1 = a p]iod ( #b ye>s1 to m>ket drugs "u ?is section incorporat+ *anges describ$ 9 clause 7ii71 subject to ! limitations "u clause 7iv71 & beg9n+ on ! date ! reque/or 7or any su* lic5sees1 assignees1 or successors 9 int]e/ ( su* reque/or7 may lawfully m>ket su* drugs pursuant to ! ord]4 7ii7 ,*anges describ$ ,a *ange describ$ 9 ?is clause is a *ange subject to an ord] specifi$ 9 clause 7i71 :i*-- 7,i7 p]mits a drug to conta9 an active +r$i5t n previ\sly incorporat$ 9 a m>ket$ drug li/$ 9 clause 7iii72 or 7,,ii7 p]mits a *ange 9 ! conditions ( use ( a drug1 = :i* 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 ,m>ket$ drugs ,! m>ket$ drugs li/$ 9 ?is clause are drugs-- 7,i7 m>ket$ 9 accordance ) a f9al monograph issu$ "u "p #ccj ( title #ba1 ,code ( ,f$]al ,regulations 7includ+ conditions ( use !reund]71 z 9 effect on ! day be=e ! date ( enactm5t ( ?is section2 7,,ii7 m>ket$ z category ,i or ,,iii 9 accordance ) a t5tative f9al monograph issu$ "u su* "p #ccj 7includ+ conditions ( use & any applicable subsequ5t det]m9ations !reund]71 z s 9 effect2 7,,iii7 m>ket$ z category ,i 9 accordance ) an advance notice ( propos$ rulemak+ issu$ "u su* "p #ccj 7includ+ conditions ( use & any applicable subsequ5t det]m9ations !reund]71 z s 9 effect2 7,,iv7 m>ket$ 9 accordance ) a f9al ord] issu$ "u ?is section2 or 7,v7 describ$ 9 subsection 7b77#a77;,c71 o!r ?an drugs subject to an active en=cem5t action "u section #cjc4 7iv7 ,limitations on product diff]5tiation 7,i7 ,only "o p]iod ,only "o #b-ye> p]iod may be grant$ p] drug "u clause 7i7 ) respect to any *ange describ$ 9 clause 7ii74 7,,ii7 ,exclusions ,no p]iod ( product diff]5tiation "u ?is subp>agraph %all apply to *anges to a drug t are-- 7aa7 ,ti] #b *anges describ$ 9 section #gdd,l7#ad77;,a72 7bb7 safety-relat$ *anges describ$ 9 section #gdd,l-#a7;a77#b77;,c71 requir$ "u p>agraph 7#e71 or any o!r *ange ! ,secret>y det]m9es necess>y to ensure safe use2 or 7cc7 *anges relat$ to me?ods ( te/+ safety or efficacy4 7v7 ,li/+ ( lic5sees1 assignees1 or successors 9 int]e/ ,! reque/ors ( an ord] describ$ 9 clause 7i7 %all1 z applicable1 submit to ! ,secret>y1 at a "t :5 a f9i%$ dosage =m subject to su* ord] is introduc$ or deliv]$ = introduction into int]/ate comm]ce1 a li/ ( lic5sees1 assignees1 or successors 9 int]e/ t h ! exclusive "r describ$ 9 su* clause4 7vi7 ,human data def9$ ,= purposes ( ?is subp>agraph1 ! t]m human data means data f cl9ical trials ( safety or effectiv5ess1 or ph>macok9etics or bioavailability /udies4 7,d7 ,in=mation reg>d+ safe nonprescription m>ket+ & use z a condition = fil+ a ,,grase reque/ 7i7 ,9 g5]al ,9 response to a reque/ "u ?is p>agraph t a drug describ$ 9 clause 7ii7 be g5]ally recogniz$ z safe & effective1 ! ,secret>y-- 7,i7 may file su* reque/1 if ! reque/ includes in=mation specifi$ "u clause 7iii7 ) respect to safe nonprescription m>ket+ & use ( su* drug2 or 7,,ii7 if ! reque/ fails to include in=mation specifi$ "u clause 7iii71 %all refuse to file su* reque/ & may require t nonprescription m>ket+ ( ! drug be pursuant to a new drug application z describ$ 9 clause 7iv74 7ii7 ,drug describ$ ,a drug describ$ 9 ?is clause is a monograph drug t conta9s an active +r$i5t n previ\sly incorporat$ 9 a drug-- 7,i7 m>ket$ 9 accordance ) a f9al monograph issu$ "u "p #ccj ( title #ba1 ,code ( ,f$]al ,regulations 7includ+ conditions ( use "u su* "p71 z 9 effect on ! day be=e ! date ( enactm5t ( ?is section2 7,,ii7 m>ket$ z category ,i 9 accordance ) a t5tative f9al monograph issu$ "u "p #ccj ( title #ba1 ,code ( ,f$]al ,regulations 7includ+ conditions ( use & any applicable subsequ5t det]m9ations "u su* "p71 z 9 effect on ! day be=e ! date ( enactm5t ( ?is section2 or 7,,iii7 m>ket$ 9 accordance ) a f9al ord] issu$ "u ?is section4 7iii7 ,suffici5t in=mation = a ?re%old demon/ration ( nonprescription m>ket+ & use ,in=mation specifi$ 9 ?is subp>agraph1 ) respect to a reque/ describ$ 9 clause 7i77,i71 is-- 7,i7 in=mation suffici5t = a ?re%old 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 7,,ii7 if ! drug has n be5 previ\sly m>ket$ 9 ! ,unit$ ,/ates z a nonprescription drug1 in=mation suffici5t = a ?re%old demon/ration t ! drug 0 m>ket$ & safely us$ 9 a =eign c\ntry "u conditions ( m>ket+ & use-- 7aa7 = su* p]iod ( "t z ne$$ to provide reasonable assurances conc]n+ ! safe nonprescription use ( ! drug2 & 7bb7 dur+ su* p]iod ( "t1 0 subject to suffici5t monitor+ by a regulatory body ( any c\ntry li/$ 9 section #hjb7;b77#a77;,a7 or any c\ntry designat$ by ! ,secret>y 9 accordance ) section #hjb7;b77#a77;,b72 or 7,,iii7 if ! ,secret>y det]m9es t in=mation describ$ 9 subclause 7,i7 or 7,,ii7 is n ne$$ to provide a ?re%old demon/ration t ! drug c be safely m>ket$ & us$ z a nonprescription drug1 o!r in=mation ! ,secret>y det]m9es suffici5t = su* purposes4 7iv7 ,m>ket+ pursuant to new drug application ,9 ! case ( a reque/ describ$ 9 clause 7i77,,ii71 ! drug subject to su* reque/ may be re-submitt$ = fil+ only if-- 7,i7 ! drug is m>ket$ z a nonprescription drug1 "u conditions ( use comp>able to ! requirem5ts specifi$ 9 ! reque/1 = su* p]iod ( ! "t z ! ,secret>y det]m9es appropriate 7n to exce$ #e consecutive ye>s7 pursuant to an application approv$ "u section #eje2 & 7,,ii7 dur+ su* p]iod ( "t1 #a1jjj1jjj retail packages ( ! drug1 or an equival5t quantity ( ! active +r$i5t or +r$i5ts ( su* drug z det]m9$ by ! ,secret>y1 7 di/ribut$ = retail sale1 z det]m9$ 9 su* mann] z ! ,secret>y may require4 7v7 ,rule ( application ,if ! ,secret>y refuses to file a reque/ "u ?is subp>agraph1 ! reque/or may n file ov] prote/ "u subp>agraph 7,a77iii7 unless ! reque/ involves a drug describ$ 9 section #ehf7i7 z 9 effect on ,janu>y #a1 #bjag4 7#g7 ,treatm5t ( f9al & t5tative f9al monographs ,a f9al monograph or t5tative f9al monograph e/abli%+ requirem5ts ( use = a drug describ$ 9 subsection 7b77#a7 %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$ures ( ?is subsection4 7#h7 ,packag+ 7,a7 ,9 g5]al ,an adm9i/rative ord] issu$ "u p>agraph 7#c71 7#e77;,a71 or 7#f7 may include requirem5ts = ! packag+ ( a drug1 su* z to promote use 9 accordance ) label+1 unit dose packag+1 or requirem5ts to prev5t accid5tal ov]dose or +e/ion1 misuse1 or abuse1 includ+ by p$iatric populations4 ,! ,secret>y %all consid]1 z appropriate1 any su* nonprescription drugs curr5tly available1 & ! impact ( ! removal ( su* drugs )\t su* packag+ & ! *ang+ ( su* packag+ on pati5ts & manufactur]s :5 e/abli%+ su* requirem5ts4 7,b7 ,effective date ,requirem5ts = packag+ 9 an adm9i/rative ord] "u p>agraph 7#e77;,b7 %all n take effect e>li] ?an ! day aft] ! date on :i* ! comm5t p]iod "u p>agraph 7#e77;,b77i77,,iii7 ends4 7,c7 ,cl>ification ,?is p>agraph does n au?orize ! ,secret>y to require special packag+ or *ild-resi/ant packag+ "u ! ,poison ,prev5tion ,packag+ ,act ( #aigj4 7d7 ,proc$ure = m9or *anges 7#a7 ,9 g5]al ,m9or *anges 9 ! dosage =m ( a drug t is describ$ 9 clause 7i77,i77aa77,,cc7 or 7ii7 ( subsection 7b77#a77;,a7 may be made by a reque/or )\t ! issuance ( an adm9i/rative ord] "u subsection 7c7 if-- 7,a7 ! reque/or ma9ta9s in=mation 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$i5t 9 comp>ison to a suitable ref]5ce product2 7,b7 ! reque/or submits updat$ drug li/+ in=mation = ! drug 9 accordance ) ! requirem5ts ( section #eaj7;j7 )9 #cj cal5d> days ( ! date on :i* ! drug is fir/ introduc$ into int]/ate comm]ce ) ! *ange2 & 7,c7 ! *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 ,! reque/or %all submit to ! ,secret>y1 "u section #gjd7;a77#d71 records reque/$ by ! ,secret>y relat$ to a m9or *ange )9 #ae bus9ess days ( receiv+ su* reque/1 or su* long] p]iod z ! ,secret>y may provide4 ,su* reque/ %all be specific to a company & limit$ to ! product & ! m9or *ange t prompt$ su* reque/4 ,su* reque/ %all be specific to a company & limit$ to ! product & ! m9or *ange t prompt$ su* reque/4 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$i5t1 ! ,secret>y-- 7i7 may s in=m ! reque/or ( ! drug 9 writ+2 & 7ii7 provide ! reque/or ( ! drug ) a reasonable opportunity to provide additional in=mation4 7,c7 ,failure to submit suffici5t in=mation ,if ! reque/or fails to provide su* additional in=mation )9 ! prescrib$ "t1 or if ! ,secret>y det]m9es t su* additional in=mation does n demon/rate t ! *ange does n affect ! safety or effectiv5ess ( ! drug or mat]ially affect ! ext5t ( absorption or o!r exposure to ! active +r$i5t1 ! drug z modifi$ is a new drug )9 ! mean+ ( section #bja7p7 & %all be deem$ to be misbr&$ "u section #ejb7;ee74 7#c7 ,det]m9+ :e!r *ange w affect safety or effectiv5ess 7,a7 ,9 g5]al ,! ,secret>y %all issue "o or m adm9i/rative ord]s "u subsection 7c7 specify+ requirem5ts = det]m9+ :e!r a m9or *ange made by a reque/or 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$i5t 9 ! drug 9 comp>ison to a suitable ref]5ce product1 toge!r ) guidance = apply+ ^? ord]s to specific dosage =ms4 7,b7 ,/&>d practices & special ne$s ( populations ,! ord]s & guidance issu$ by ! ,secret>y "u subp>agraph 7,a7 %all take into acc\nt relevant public /&>ds & /&>d practices = evaluat+ ! quality ( drug products & may take into acc\nt special ne$s ( populations1 includ+ *ildr54 7e7 ,in=mation submitt$ by reque/ors 7#a7 ,confid5tial in=mation ,any in=mation1 includ+ reports ( te/+ conduct$ on ! drug or drugs involv$1 t is submitt$ by a reque/or 9 connection ) proce$+s on an adm9i/rative ord] "u ?is section 7or any m9or *ange "u subsection 7d77 & is a trade secret or confid5tial in=mation subject to section #eeb7;b77#d7 ( title #e1 ,unit$ ,/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 limitations ,! ,secret>y %all make available to ! public any in=mation 7o!r ?an in=mation conta9$ 9 subject-level data sets1 su* z ^? d]iv$ f individual case report =ms7 submitt$ by a reque/or 9 support ( a reque/ "u subsection 7c77#f77;,a7 z ( ! date on :i* ! propos$ ord] is issu$ unless-- 7,a7 ! in=mation p]ta9s to ph>maceutical quality1 unless su* in=mation is necess>y to e/abli% /&>ds "u :i* a drug is g5]ally recogniz$ z safe & effective )9 ! mean+ ( section #bja7p77#a72 7,b7 ! in=mation is submitt$ 9 a reque/or-initiat$ reque/1 b ! reque/or )draws su* reque/ be=e ! ,secret>y issues ! propos$ ord] 9 accordance ) )drawal proc$ures e/abli%$ by ! ,secret>y2 or 7,c7 ! ,secret>y o!rwise obta9s ! in=mation "u subsection 7d74 7f7 ,public availability ( adm9i/rative ord]s ,! ,secret>y %all e/abli%1 ma9ta91 update 7z ! ,secret>y det]m9es necess>y1 b n less frequ5tly ?an annually71 & make available on ! int]net website ( ! ,food & ,drug ,adm9i/ration-- 7#a7 a repository ( ea* f9al adm9i/rative ord] & int]im f9al ord] issu$ "u subsection 7c7 t is 9 effect1 includ+ ! complete text ( ! adm9i/rative ord]2 & 7#b7 a li/+ ( all adm9i/rative ord]s propos$ & "u developm5t on ! initiative ( ! ,secret>y "u ?is section1 includ+-- 7,a7 a brief description ( ! adm9i/rative ord]2 & 7,b7 ! expectations ( ! ,secret>y1 = issuance ( propos$ adm9i/rative ord]s ov] a #c-ye> p]iod4 7g7 ,updates to drug li/+ in=mation ,a sponsor :o makes a *ange to a drug o!r ?an a *ange 9 dosage =m1 :i* is 9 con=mity ) ! requirem5ts "u subp>agraph 7,a7 or 7,b7 ( subsection 7b77#a71 %all n be subject to ! requirem5ts ( subsection 7c7 or 7d7 ) respect to su* *ange1 & %all submit updat$ drug li/+ in=mation = ! drug 9 accordance ) ! requirem5ts ( section #eaj7;j7 )9 #cj cal5d> days ( ! date on :i* ! drug1 ) ! *ange1 is fir/ introduc$ or deliv]$ = introduction into int]/ate comm]ce4 7h7 ,approvals "u section #eje ,?is section %all n be con/ru$ to preclude a sponsor ( a drug or reque/or f seek+ or ma9ta9+ ! approval ( an application = su* drug "u subsection 7b77#a71 7b77#b71 or 7j7 ( section #eje4 ,a det]m9ation "u ?is section t a drug is n subject to section #ejc7;b77#a71 is g5]ally recogniz$ z safe & effective )9 ! mean+ ( section #bja7p77#a71 & is n a new drug "u section #bja7p71 %all con/itute a f9d+ ( safety & effectiv5ess = purposes ( section #eje7;b77#b7 s t ! applicant %all be requir$ to submit only t in=mation ne$$ to support ! modification ( ! drug t is subject to ! det]m9ation "u ?is section4 7i7 ,developm5t advice to reque/ors or sponsors 7#a7 ,9 g5]al ,! ,secret>y %all e/abli% proc$ures "u :i* reque/ors may meet ) appropriate (ficials ( ! ,food & ,drug ,adm9i/ration to obta9 advice on ! /udies & o!r in=mation necess>y to support reque/s "u ?is section & o!r matt]s relevant to ! regulation ( monograph drugs & ! developm5t ( new monograph drugs "u ?is section4 7#b7 ,p>ticipation ( multiple sponsors ,! ,secret>y %all e/abli% proc$ures to facilitate effici5t p>ticipation by multiple reque/ors 9 proce$+s "u ?is section1 includ+ provision = jo9t meet+s ) multiple reque/ors or ) organizations nom9at$ by reque/ors to repres5t _! int]e/s 9 a proce$+4 7#c7 ,private meet+s ) reque/ors ,! proc$ures e/abli%$ "u ?is subsection %all include appropriate provision = confid5tial meet+s ) reque/ors ) respect to discussion ( matt]s involv+ confid5tial comm]cial in=mation or trade secrets4 7j7 ,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 ,9 g5]al ,section #caj4ede ( title #ba1 ,code ( ,f$]al ,regulations1 z 9 effect on ! date ( enactm5t ( ?is section1 %all be deem$ to be f9al adm9i/rative ord] "u subsection 7c74 7,b7 ,o!r regulations ,regulations e/abli%+ requirem5ts = specific nonprescription drugs m>ket$ pursuant to ?is section t are 9 effect on ! day be=e ! date ( enactm5t ( ?is section 7includ+ su* requirem5ts 9 p>ts #bja1 #bej1 & #ccj ( title #ba1 ,code ( ,f$]al ,regulations71 %all be deem$ to be f9al adm9i/rative ord]s "u subsection 7c7 only z su* requirem5ts apply to monograph drugs4 7,c7 ,effective date p]iod ,unless )drawn or revis$ by ! ,secret>y1 ! regulations "u title #ba ( ! ,code ( ,f$]al ,regulations t are describ$ 9 subp>agraph 7,b7 %all rema9 9 effect ) respect to drugs n subject to subp>agraph 7,a71 7,b71 7,c71 or 7,d7 ( subsection 7b77#a74 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 ,act71 or make te*nical *anges to su* regulations to ensure con=mity ) appropriate t]m9ology & cross ref]5ces1 to ! ext5t ne$$ to effectuate or h>monize ! provisions ( ?is section4 ,not)/&+ sub*apt] ,,ii ( *apt] #e ( title #e1 ,unit$ ,/ates ,code1 any su* )drawal or te*nical am5dm5ts %all be made )\t public notice & comm5t & be effective ^u publication ?r\gh notice 9 ! ,f$]al ,regi/] 7or ^u su* date z specifi$ 9 su* notice74 7k7 ,guidance 7#a7 ,issuance ,! ,secret>y %all issue guidance t provides-- 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$+s & ! proc$ures = su* proce$+s :]e appropriate2 & 7,e7 = m9or *anges 9 drugs1 recomm5dations on h[ to comply ) ! requirem5ts 9 adm9i/rative ord]s issu$ "u subsection 7c77#c74 7l7 ,electronic =mat ,all submissions "u ?is section %all be 9 an electronic =mat specifi$ by ! ,secret>y aft] provid+ a p]iod = public comm5t4 7m7 ,inapplicability ( ,pap]work ,r$uction ,act ,*apt] #ce ( title #dd1 ,unit$ ,/ates ,code1 %all n apply to collections ( in=mation made "u ?is section4 4 #ajb4 ,misbr&+ ,section #ejb ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #ceb7 is am5d$ by ins]t+ aft] subsection 7dd7 ! foll[+3 7ee7 ,if x is a nonprescription drug t is n ! subject ( an application approv$ "u section #eje1 & does n comply ) ! requirem5ts "u section #eje;,g4 7ff7 ,if x is a drug = :i* fees "u section #gdd,l-#a h be5 assess$ b h n be5 paid4 4 #ajc4 ,con=m+ am5dm5ts to ! ,sunscre5 ,innovation ,act 7a7 ,review ( nonprescription +r$i5ts subject to ,sunscre5 ,innovation ,act 7#a7 ,p5d+ sunscre5 +r$i5ts ,nonprescription sunscre5 active +r$i5ts or comb9ations ( sunscre5 active +r$i5ts subject1 on ! date ( enactm5t ( ?is ,act1 to a propos$ sunscre5 ord]1 z def9$ 9 section #ehf7g7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;fff7#g771 %all-- 7,a7 cont9ue to be review$ 9 accordance ) section #ehf;,c ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;fff-#c72 or 7,b7 be review$ "u section #eje;,g ( su* ,act ^u notification ( ! ,secret>y by ! sponsor t su* sponsor elects to h su* +r$i5t or comb9ation ( +r$i5ts review$ "u su* section #eje;,g1 & su* propos$ sunscre5 ord] "u su* section #ehf;,c %all be consid]$ a propos$ adm9i/rative ord] "u section #eje;,g7c77#c77;,a77ii7 ( su* ,act4 7#b7 ,p5d+ nonsunscre5 +r$i5ts ,! sponsor ( any application describ$ 9 section #ehf;,f ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;fff-#f7 t 0 submitt$ to ! ,secret>y ( ,heal? & ,human ,s]vices 7ref]r$ to 9 ?is section z ! ,secret>y7 pursuant to section #ccj4ad ( title #ba1 ,code ( ,f$]al ,regulations 7z 9 effect on ! day be=e ! date ( enactm5t ( ?is ,act71 %all-- 7,a7 notify ! ,secret>y t ! sponsor elects to )draw su* application2 or 7,b7 notify ! ,secret>y t ! sponsor elects = su* +r$i5t to be consid]$ "u section #eje;,g ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act1 & any propos$ ord] "u su* section #ehf;,f %all be consid]$ a propos$ adm9i/rative ord] "u section #eje;,g7c77#c77;,a77ii7 ( t ,act4 7#c7 ,+r$i5ts submitt$ aft] ! date ( enactm5t ( section #ejf;,g ,any +r$i5t t is eligible = review "u section #ejf;,g ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act & is submitt$ aft] ! date ( enactm5t ( ?is ,act %all be consid]$ "u t section4 7b7 ,meet+s reg>d+ sunscre5 +r$i5ts ,section #ehf;,c7b7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;fff-#c7;b77 is am5d$ by add+ at ! end ! foll[+3 7#aa7 ,meet+s ) sponsors ,a sponsor may reque/ an individual1 confid5tial meet+ to discuss ! data requirem5ts to support a g5]al recognition ( safety & effectiv5ess ) respect to ! subject ( a p5d+ sunscre5 +r$i5t4 ,! ,secret>y %all respond )9 #ad cal5d> days ( ! reque/ & s*$ule su* meet+ )9 #de cal5d> days1 or )9 su* timel9e z specifi$ 9 ! lett]s describ$ 9 section #bja ( ! ,ov]-!-,c\nt] ,drug ,safety1 ,innovation1 & ,re=m ,act4 ,if a sponsor reque/s m ?an "o confid5tial meet+ = ! same reque/1 ! ,secret>y may refuse to grant an additional confid5tial meet+ reque/ if ! ,secret>y det]m9es su* additional confid5tial meet+ is n reasonably necess>y = ! sponsor to advance its reque/4 ,! ,secret>y %all publi% a po/-meet+ summ>y on ! int]net website ( ! ,food & ,drug ,adm9i/ration ( any confid5tial meet+ t does n disclose confid5tial bus9ess in=mation4 ,su* meet+s %all n be requir$ to comply ) guidance issu$ by ! ,secret>y address+ =mal meet+s = sponsors ( human drug applications1 z def9$ 9 section #gce4 4 7c7 ,product diff]5tiation ,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 ,product diff]5tiation 7#a7 ,9 g5]al ,a f9al sunscre5 ord] %all h ! effect ( provid+ ! 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 ! exclusive "r1 = a p]iod ( #b ye>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-- 7,a7 p]mits a sunscre5 to conta9 an active +r$i5t n previ\sly incorporat$ 9 a m>ket$ sunscre5 li/$ 9 p>agraph 7#c72 or 7,b7 p]mits a *ange 9 ! conditions ( use ( a sunscre5 +r$i5t1 = :i* human data /udies conduct$ or sponsor$ by ! reque/or 7or = :i* ! reque/or has an exclusive "r ( ref]5ce7 7 ess5tial to ! issuance ( su* ord]4 7#c7 ,m>ket$ sunscre5 ,! m>ket$ sunscre5 +r$i5ts describ$ ?is p>agraph are sunscre5 +r$i5ts-- 7,a7 m>ket$ 9 accordance ) a f9al monograph issu$ "u "p #ccj ( title #ba1 ,code ( ,f$]al ,regulations 7includ+ conditions ( use !reund]71 z 9 effect on ! day be=e ! date ( enactm5t ( ?is section2 7,b7 m>ket$ z category ,i or ,,iii 9 accordance ) a t5tative f9al monograph issu$ "u su* "p #ccj 7includ+ conditions ( use & any applicable subsequ5t det]m9ations !reund]71 z s 9 effect2 7,c7 m>ket$ z category ,i 9 accordance ) an advance notice ( propos$ rulemak+ issu$ "u su* "p #ccj 7includ+ conditions ( use & any applicable subsequ5t det]m9ations !reund]71 z s 9 effect2 or 7,d7 m>ket$ 9 accordance ) a f9al ord] issu$ "u ?is section4 7#d7 ,limitations on product diff]5tiation 7,a7 ,only "o p]iod ,only "o #b-ye> p]iod may be grant$ p] +r$i5t "u p>agraph 7#a74 7,b7 ,exclusions ,no p]iod ( product diff]5tiation "u ?is subp>agraph %all apply to *anges to a sunscre5 t are-- 7i7 ,ti] #b *anges describ$ 9 section #gdd,l7#ad77;,a72 7ii7 safety-relat$ *anges describ$ 9 section #gdd,l-#a7;a77#b77;,c71 requir$ "u section #eje;,g7c77#e71 or any o!r *ange ! ,secret>y det]m9es necess>y to ensure safe use2 or 7iii7 *anges relat$ to me?ods ( te/+ safety or efficacy4 7#e7 ,li/+ ( lic5sees1 assignees1 or successors 9 int]e/ ,reque/ors %all submit to ! ,secret>y at ! "t :5 a f9al dosage =m subject to su* reque/ is introduc$ or deliv]$ = introduction into int]/ate comm]ce1 a li/ ( lic5sees1 assignees1 or successors 9 int]e/ t h ! exclusive "r describ$ 9 p>agraph 7#a74 7#f7 ,human data def9$ ,= purposes ( ?is subsection1 ! t]m human data means data f cl9ical trials ( safety or effectiv5ess 7includ+ actual use /udies71 ph>macok9etics1 or bioavailability4 4 7d7 ,sunscre5 ,innovation ,act am5dm5ts ,section #ehf;,c7e7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;fff-#c7;e77 is am5d$ by /rik+ p>agraph 7#c7 & ins]t+ ! foll[+3 7#c7 ,relation%ip to ord]s "u section #eje;,g ,a f9al sunscre5 ord] %all be deem$ to be a f9al adm9i/rative ord] "u section #eje;,g & subject to ! applicable provisions "u su* section #eje;,g1 includ+ ) respect to am5dm5t ( su* ord]4 4 7e7 ,preclusion ( new sunscre5 submissions2 option ,to transf] submissions to ,,otc monograph ord] process 7#a7 ,sunset ,beg9n+ on ! date ( enactm5t ( ?is ,act1 section #ehf;,a ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;fff-#a7 %all h no =ce or effect4 7#b7 ,option ,to transf] submissions to ,,otc monograph ord] process 7,a7 ,9 g5]al ,any p]son :o submitt$ a reque/ describ$ 9 subp>agraph 7,b7 may1 at any "t prior to ! sunset ( sub*apt] ,i ( *apt] ,v ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;fff et seq47 "u section #ehf;,h ( su* ,act1 )draw su* reque/ f ! process "u su* sub*apt] & resubmit su* reque/ z an ord] reque/ "u section #eje;,g ( su* ,act4 7,b7 ,reque/s ,a reque/ describ$ 9 ?is subp>agraph is-- 7i7 a reque/ "u section #ehf;,a ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act submitt$ be=e ! date ( enactm5t ( ?is ,act2 or 7ii7 a p5d+ reque/ describ$ 9 section #ehf7f74 7f7 ,treatm5t ( au?ority reg>d+ f9alization ( sunscre5 monograph ,section #ehf;,e ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;fff-#e7 is am5d$ to read z foll[s3 #ehf;,e4 ,sunscre5 ord] 7a7 ,9 g5]al 7#a7 ,revision ( f9al sunscre5 ord] ,n lat] ?an ,novemb] #bf1 #bjai1 ! ,secret>y %all am5d & revise ! f9al adm9i/rative ord] conc]n+ nonprescription sunscre5 7ref]r$ to 9 ?is section z ! sunscre5 ord]7 = :i* ! sub/ance1 prior to ! date ( enactm5t ( ! ,ov]-!-,c\nt] ,drug ,safety1 ,innovation1 & ,re=m ,act1 0 repres5t$ by /ay$ regulations "u "p #ceb ( title #ba1 ,code ( ,f$]al ,regulations4 7#b7 ,issuance ( revis$ sunscre5 ord]2 effective date ,a revis$ sunscre5 ord] describ$ 9 p>agraph 7#a7 %all be-- 7,a7 effective n lat] ?an ,novemb] #bf1 #bjai2 & 7,b7 issu$ by ! ,secret>y at lea/ #cj cal5d> days prior to su* date4 7b7 ,reports ,if a revis$ sunscre5 ord] issu$ "u subsection 7a7 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 #eje1 ! ,secret>y %all submit a report to ! ,committee on ,heal?1 ,education1 ,labor1 & ,p5sions ( ! ,s5ate & ! ,committee on ,en]gy & ,comm]ce ( ! ,h\se ( ,repres5tatives 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 4 7g7 ,sunset ( process "u ,sunscre5 ,innovation ,act ,sub*apt] ,i ( *apt] ,v ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;fff et seq471 z am5d$ by subsection 7f71 is fur!r am5d$ by ins]t+ at ! end ! foll[+ new section3 #ehf;,h4 ,sunset ,?is sub*apt] %all no long] be effective ^u ! lat] (-- 7#a7 a f9al det]m9ation by ! ,secret>y "u ?is sub*apt] ) respect to e reque/ describ$ 9 section #ehf;,a7b77#b7 7o!r ?an any )drawn reque/s & reque/s resubmitt$ z ord] reque/s "u section #eje;,g72 or 7#b7 ! effective date ( ! revis$ sunscre5 ord] describ$ 9 section #ehf;,e7a77#b74 4 #ajd4 ,drugs exclud$ f ov]-!-c\nt] review 7a7 ,9 g5]al ,no?+ 9 ?is ,act 7or ! am5dm5ts made by ?is ,act7 %all apply to any nonprescription drug :i* 0 exclud$ by ! ,food & ,drug ,adm9i/ration f ! ,ov]-!-,c\nt] ,drug ,review 9 accordance ) ! /atem5t set out at 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 provision ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act4 #aje4 ,con=m+ am5dm5t ,section #gea7;d77#a7 ( ! ,f$]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 & ins]t+ f9al ord]2 & 7,b7 by /rik+ & n misbr&$2 & 7#b7 9 subp>agraph 7,a71 by /rik+ regulation 9 effect & ins]t+ regulation or ord] 9 effect4 #ajf4 ,annual update to ,congress on appropriate p$iatric indication = c]ta9 c\gh & cold monograph drugs 7a7 ,9 g5]al ,n lat] ?an "o ye> aft] ! date ( enactm5t ( ?is ,act & annually !reaft]1 ! ,secret>y ( ,heal? & ,human ,s]vices 7ref]r$ to 9 ?is section z ! ,secret>y7 %all submit to ! ,committee on ,heal?1 ,education1 ,labor1 & ,p5sions ( ! ,s5ate & ! ,committee on ,en]gy & ,comm]ce ( ! ,h\se ( ,repres5tatives 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* *ildr51 ?r\gh ! adm9i/rative ord] process "u section #eje;,g7b7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act1 z add$ by section #aja4 7b7 ,c\gh & cold monograph describ$ ,! c\gh & cold monograph describ$ 9 ?is subsection consi/s ( ! conditions "u :i* nonprescription drug products 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$]al ,regulations 7z 9 effect on ! day be=e ! date ( enactm5t ( ?is ,act71 & includ$ 9 an adm9i/rative ord] deem$ e/abli%$ "u su* section #eje;,g7b7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act4 7c7 ,duration ( au?ority ,subsection 7a7 %all h no =ce or effect beg9n+ on ! date on :i* ! ,secret>y submits a lett] "u subsection 7a7 9 :i* ! ,secret>y indicates t ! ,food & ,drug ,adm9i/ration has complet$ its evaluation & revis$1 9 a f9al adm9i/rative ord]1 z applicable1 ! c\gh & cold monograph 9 accordance ) ?is section4 ,,ii ,fees relat+ to monograph drugs #bja4 ,%ort title2 f9d+s 7a7 ,%ort title ,?is title may be cit$ z ! ,ov]-!-,c\nt] ,monograph ,us] ,fee ,act ( #bjah4 7b7 ,f9d+s ,! ,congress f9ds t ! fees au?oriz$ by ! am5dm5ts made 9 ?is title w be d$icat$ t[>d ! regulation ( monograph drugs "u section #eje;,g ( ! ,f$]al1 ,food1 ,drug1 & ,cosmetic ,act1 z set =? 9 ! goals id5tifi$ = purposes ( su* section1 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 access & use 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 monograph drugs #gdd,l4 ,def9itions ,= purposes ( ?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 a monograph drug facility :]e nei!r ! own] ( su* manufactur+ facility nor any affiliate ( su* own] or facility sells su* 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$ = monograph drug activities means ! exp5ses 9 connection ) 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 & 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,l-#a & acc\nt+ = res\rces allocat$ = monograph drug activities4 7#d7 ,! t]m firm e/abli%m5t id5tifi] is ! unique numb] automatically g5]at$ by ! ,field ,accompli%m5ts & ,compliance ,track+ ,sy/em ( ! ,food & ,drug ,adm9i/ration4 7#e7 ,! t]m monograph drug %all h ! mean+ giv5 ! t]m "u section #eje;,g4 7#f7 ,! t]m monograph drug activities means activities ( ! ,secret>y associat$ ) monograph drug products & inspection ( facilities associat$ ) su* products1 includ+-- 7,a7 ! activities necess>y = review & evaluation ( monograph drugs & monograph drug ord] reque/s1 includ+-- 7i7 ord]s propos+ or f9aliz+ applicable requirem5ts ( use = monograph drugs products2 7ii7 ord]s affect+ /atus reg>d+ g5]al recognition ( safety & effectiv5ess ( a monograph drug +r$i5t or comb9ation ( +r$i5ts "u specifi$ requirem5ts ( use2 7iii7 all monograph drug developm5t & review activities1 includ+ intra-ag5cy collaboration2 7iv7 regulation & policy developm5t activities relat$ to monograph drugs2 7v7 developm5t ( product /&>ds = products subject to review & evaluation2 7vi7 meet+s reg>d+ monograph drug activities2 7vii7 review ( label+ prior to issuance ( ord]s relat$ to monograph drugs or conditions ( use2 & 7viii7 regulatory sci5ce activities relat$ to monograph drugs2 7,b7 inspections relat$ to monograph drugs2 7,c7 monitor+ ( cl9ical & o!r rese>* conduct$ 9 connection ) monograph drugs2 7,d7 safety activities ) respect to monograph drugs1 includ+-- 7i7 collect+1 develop+1 & review+ safety in=mation on 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 databases2 & 7,e7 o!r activities necess>y = implem5tation ( section #eje;,g4 7#g7 7,a7 ,! t]m monograph drug facility means a =eign or dome/ic bus9ess or o!r entity-- 7i7 t is "u "o managem5t1 ei!r direct or indirect2 7ii7 at "o geographic location or address engag$ 9 manufactur+ or process+ a monograph drug 9 f9i%$ dosage =m2 7iii7 includes a f9i%$ dosage =m manufactur] facility or an affiliate !re( 9 a contractual relation%ip ) a monograph drug reque/or or reque/ors to manufacture or process monograph drugs2 & 7iv7 does n include a bus9ess or o!r entity ^: only manufactur+ or process+ activities relate to-- 7,i7 production ( cl9ical rese>* supplies2 7,,ii7 te/+2 or 7,,iii7 packag+ ( packag$ f9al dosages 9 a mann] t does n affect ! drug4 7,b7 ,= purposes ( subp>agraph 7,a71 sep>ate build+s or locations )9 close proximity are consid]$ to be at #a geographic location or address if ! activities conduct$ 9 !m are-- 7i7 closely relat$ to ! same bus9ess ent]prise2 7ii7 "u ! sup]vision ( ! same local managem5t2 & 7iii7 "u a s+le firm 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 ! def9ition ( a facility "u ?is p>agraph 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#h7 ,! t]m monograph drug meet+ means any meet+ reg>d+ ! cont5t ( a propos$ monograph drug ord] reque/4 7#i7 ,! t]m monograph drug product means a monograph drug product t is m>ket$ )\t an approv$ new drug application 9 accordance ) section #eje;,g4 7#aj7 ,! t]m monograph drug ord] reque/ means a reque/ = an ord] "u section #eje;,g = ! issuance ( an adm9i/rative ord] = a *ange to ! monograph drug product4 7#aa7 ,! t]m monograph drug reque/or means an entity submitt+ a monograph drug ord] reque/ or a monograph drug meet+ reque/ or any o!r inquiry relat+ to a reque/ = an ord] or developm5t ( a monograph drug ord] reque/4 7#ab7 ,! t]m p]son includes an affiliate !re(4 7#ac7 ,! t]m ,ti] #a monograph drug ord] reque/ means any monograph drug ord] reque/ n det]m9$ to be a ,ti] #b monograph drug ord] reque/4 7#ad7 7,a7 ,! t]m ,ti] #b monograph drug ord] reque/ means subject to subp>agraph 7,b71 a monograph drug ord] reque/ =-- 7i7 ! reord]+ ( exi/+ in=mation 9 ! drug facts label ( a monograph drug product2 7ii7 ! addition ( in=mation to ! o!r in=mation section ( ! drug facts label ( a nonprescription drug product1 z limit$ by "p #bja4ff7;c77#g7 ( title #ba1 ,code ( ,f$]al ,regulations2 7iii7 modification to ! directions = use section ( ! drug facts label ( a nonprescription drug product1 if su* *anges con=m to *anges made pursuant to section #eje;,g7d72 7iv7 ! /&>dization ( ! conc5tration or dose ( a specific f9aliz$ +r$i5t )9 a p>ticul> f9aliz$ monograph2 7v7 a *ange to +r$i5t nom5clature to align ) nom5clature ( a /&>ds-sett+ organization2 or 7vi7 addition ( an int]*angeable t]m 9 accordance ) "p #ccj4a ( title #ba1 ,code ( ,f$]al ,regulations4 7,b7 ,! ,secret>y may1 bas$ on program implem5tation exp]i5ce or o!r factors f\nd appropriate by ! ,secret>y1 *>act]ize any monograph drug ord] reque/ z a ,ti] #b monograph drug ord] reque/ 7includ+ recategoriz+ a reque/ f ,ti] #a to ,ti] #b7 & publi% su* det]m9ation 9 a propos$ ord] issu$ pursuant to section #eje;,g7c74 #gdd,l-#a4 ,au?ority to assess & use monograph drug fees 7a7 ,types ( fees ,beg9n+ ) fiscal ye> #bjah1 ! ,secret>y %all assess & collect fees 9 accordance ) ?is section z foll[s3 7#a7 ,facility fee 7,a7 ,9 g5]al ,except z provid$ 9 subp>agraph 7,b71 ea* p]son t owns a facility id5tifi$ z a 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 ,exception 7i7 ,9 g5]al ,a fee %all n be assess$ "u subp>agraph 7,a7 if ! id5tifi$ monograph drug facility has ceas$ all activities relat$ to monograph drug products prior to ! publication ( ! ,notice "u subp>agraph ,c & has updat$ its regi/ration to reflect su* *ange "u ! requirem5ts = drug e/abli%m5t regi/ration set =? 9 section #eaj4 7ii7 ,fee am\nt ,! am\nt ( ! fee = a contract manufactur+ organization facility %all be equal to two-?irds ! am\nt ( ! fee = a monograph drug facility t is n a contract manufactur+ organization facility4 7,c7 ,due date ,= ea* fiscal ye>1 ! facility fees requir$ "u subp>agraph 7,a7 %all be due on ! lat] (-- 7i7 ! fir/ bus9ess day ( ,april ( su* ye>2 & 7ii7 ! fir/ bus9ess day aft] ! date ( enactm5t ( an appropriations ,act provid+ = ! collection & obligation ( fees "u ?is section = su* ye>4 7#b7 ,monograph drug ord] reque/ fee 7,a7 ,9 g5]al ,ea* p]son t submits a monograph drug ord] reque/ %all be subject to a fee = a monograph drug ord] reque/4 ,! monograph drug ord] reque/ fee "u p>agraph 7#b7 %all be-- 7i7 = a ,ti] #a monograph drug ord] reque/1 #ejj1jjj1 adju/$ = inflation = ! fiscal ye> 7z det]m9$ "u subsection 7c77#a772 & 7ii7 = a ,ti] #b monograph drug ord] reque/ o!r ?an a ,ti] #a reque/1 #ajj1jjj adju/$ = inflation = ! fiscal ye> 7z det]m9$ "u subsection 7c77#a774 7,b7 ,due date ,! monograph drug ord] reque/ fees requir$ "u subp>agraph 7,a7 %all be due on ! date ( submission ( ! monograph drug ord] reque/4 7,c7 ,exception = c]ta9 safety *anges ,a p]son :o is nam$ z ! reque/or 9 a monograph drug ord] %all n be subject to a fee "u subp>agraph 7,a7 if ! ,secret>y f9ds t ! monograph drug ord] reque/ seeks to *ange ! ,drug ,facts label+ ( a monograph drug product 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 ( ! monograph drug product4 7,d7 ,refund ( fee if ord] reque/ is recategoriz$ z a ti] #b monograph drug ord] reque/ ,if ! ,secret>y det]m9es t a monograph drug reque/ initially *>act]iz$ z ,ti] #a %\ld be re-*>act]iz$ z a ,ti] #b monograph drug 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/ t is refus$ = fil+4 7,f7 ,fees = ord] reque/s previ\sly refus$ = fil+ or )drawn be=e fil+ ,a monograph drug 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$4 ,! ,secret>y %all h ! sole discretion to refund a fee or a portion ( ! fee "u ?is subp>agraph4 ,a det]m9ation by ! ,secret>y conc]n+ a refund "u ?is p>agraph %all n be reviewable4 7#c7 ,refunds 7,a7 ,9 g5]al ,o!r ?an refunds "u subp>agraphs 7,d7 ?r\gh 7,g7 ( p>agraph 7#b71 ! ,secret>y %all n refund any fee paid "u ?is subsection1 except z provid$ 9 subp>agraph 7,b74 7,b7 ,disputes conc]n+ fees ,to qualify = ! return ( a fee claim$ to h be5 paid 9 error "u ?is p>agraph1 a p]son %all submit to ! ,secret>y a writt5 reque/ ju/ify+ su* return )9 #ahj cal5d> days aft] su* fee 0 paid4 7b7 ,fee rev5ue am\nts 7#a7 ,fiscal ye> #bjah ,= fiscal ye> #bjah1 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> #bjah 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 #bjai ?r\gh #bjbb1 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> #bjai4 7ii7 #f1jjj1jjj = fiscal ye> #bjbj4 7iii7 #g1jjj1jjj = fiscal ye> #bjba4 7iv7 #c1jjj1jjj = fiscal ye> #bjbb4 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> #bjah1 #h1jjj1jjj2 & 7,b7 = fiscal ye>s #bjai ?r\gh #bjbb1 ! 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> #bjai & 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,b74 7,b7 ,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 #bjai ?r\gh #bjbj1 ! 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 #bjba & #bjbb1 ! 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 ( monograph drug activities 7z def9$ 9 subsection 7a77 = ! 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 ( monograph drug activities = ! fir/ #c ye>s ( ! prec$+ #d fiscal ye>s4 7#b7 ,op]at+ res]ve adju/m5t 7,a7 ,= fiscal ye> #bjah & subsequ5t fiscal ye>s1 ! ,secret>y may1 9 addition to adju/m5ts "u p>agraphs 7#a7 & 7#b71 fur!r increase ! fee rev5ue & fees if su* an adju/m5t is necess>y to provide op]at+ res]ves ( c>ryov] us] fees = monograph drug activities = ! numb] ( weeks specifi$ 9 subp>agraph 7,b74 7,b7 ,= ea* fiscal ye> ! numb] ( weeks ( op]at+ res]ves %all be no m ?an-- 7i7 #c weeks = fiscal ye> #bjah2 7ii7 #g weeks = fiscal ye> #bjai2 7iii7 #aj weeks = fiscal ye> #bjbj2 7iv7 #aj weeks = fiscal ye> #bjba2 & 7v7 #aj weeks = fiscal ye> #bjbb4 7,c7 ,if1 = fiscal ye>s #bjai ?r\gh #bjbb1 ! ,secret>y has c>ryov] balances = monograph drug activities 9 excess ( ! numb] ( weeks ( su* op]at+ res]ves specifi$ 9 subp>agraph ,b1 ! ,secret>y %all r$uce su* fee rev5ue & fees to provide = n m ?an ! numb] ( weeks ( su* op]at+ res]ves specifi$ 9 subp>agraph 7,b77v74 7,d7 ,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#e7 e/abli%+ fee rev5ue & fees = ! fiscal ye> involv$4 7#c7 ,additional direct co/ adju/m5t ,! ,secret>y %all1 9 addition to adju/m5ts "u p>agraphs 7#a7 & 7#b71 fur!r increase ! fee rev5ue by an am\nt equal to-- 7,a7 #ad1jjj1jjj = fiscal ye> #bjah2 7,b7 #g1jjj1jjj = fiscal ye> #bjai2 7,c7 #d1jjj1jjj = fiscal ye> #bjbj2 7,d7 #c1jjj1jjj = fiscal ye> #bjba2 & 7,e7 #c1jjj1jjj = fiscal ye> #bjbb4 7#d7 ,annual fee sett+ 7,a7 ,fiscal ye> #bjah ,! ,secret>y %all1 n lat] ?an ,janu>y #ca1 #bjah-- 7i7 e/abli% monograph drug facility fees = fiscal ye> #bjah "u subsection 7a77#a71 bas$ on ! rev5ue am\nt = su* ye> "u subsection 7b7 & ! adju/m5ts provid$ "u ?is subsection2 & 7ii7 publi% su* fee rev5ue & facility fees 9 ! ,f$]al ,regi/]4 7,b7 ,subsequ5t fiscal ye>s ,! ,secret>y %all1 n lat] ?an ,janu>y #ca ( ea* fiscal ye> t beg9s aft] ,septemb] #cj1 #bjah1 e/abli% = ea* su* fiscal ye>1 bas$ on ! rev5ue am\nts "u subsection 7b7 & ! adju/m5ts provid$ "u ?is subsection-- 7i7 monograph drug facility fees "u subsection 7a77#a72 7ii7 monograph drug ord] reque/ fees "u subsection 7a77#b72 & 7iii7 publi% su* fee rev5ue1 facility fees1 & monograph drug ord] reque/ fees 9 ! ,f$]al ,regi/]4 7d7 ,id5tification ( facilities ,ea* p]son t owns a monograph drug facility %all submit to ! ,secret>y ! in=mation requir$ "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 ( a monograph drug facility4 7e7 ,effect ( failure ,to pay fees 7#a7 ,9 g5]al ,a monograph drug 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 h be5 paid4 7#b7 ,effect on eligibility = meet+s ,if a monograph drug reque/or fails to pay a fee assess$ "u subsection 7a71 ! reque/or %all be consid]$ ineligible = monograph drug meet+s4 7f7 ,monograph drug facility fee ,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 ! ,secret>y plac+ ! facility on a publicly available arre>s li/ until su* fee has be5 paid4 7g7 ,cr$it+ & availability ( fees 7#a7 ,9 g5]al ,subject to p>agraph 7#b77;,d71 fees au?oriz$ "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 = monograph drug activities4 7#b7 ,collections & appropriation 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 = 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$ = 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$4 7,c7 ,compliance ,! ,secret>y %all be consid]$ to h met ! requirem5ts ( subp>agraph 7,b7 9 any fiscal ye> if ! co/s fund$ by appropriations & allocat$ = ! monograph drug activities are n m ?an #ae p]c5t bel[ ! level specifi$ 9 su* subp>agraph4 7,d7 ,fee collection dur+ fir/ program ye> ,until ! date ( enactm5t ( an ,act mak+ appropriations & provid+ = ! collection & obligation ( fees "u ?is section ?r\gh ,septemb] #cj1 #bjah1 = ! sal>ies & exp5ses acc\nt ( ! ,food & ,drug ,adm9i/ration1 fees au?oriz$ by ?is section = fiscal ye> #bjah may be collect$ & %all be cr$it$ to su* acc\nt & rema9 available until exp5d$4 7,e7 ,provision = e>ly paym5ts 9 subsequ5t ye>s ,paym5t ( fees au?oriz$ "u ?is section = a fiscal ye> 7aft] fiscal ye> #bjah71 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 #bjah ?r\gh #bjbb1 !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 7h7 ,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 #ca4 7i7 ,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 monograph drug activities1 be r$uc$ to (fset ! numb] ( (fic]s1 employees1 & advisory committees s engag$4 #gdd,l-#b4 ,reau?orization2 report+ requirem5ts 7a7 ,p]=mance report ,beg9n+ ) fiscal ye> #bjah1 & n lat] ?an #abj cal5d> days aft] ! end ( ea* fiscal ye> !reaft] = :i* fees are collect$ "u ?is "p1 ! ,secret>y %all prep>e & submit to ! ,committee on ! ,heal?1 ,education1 ,labor1 & ,p5sions ( ! ,s5ate & ! ,committee on ,en]gy & ,comm]ce ( ! ,h\se ( ,repres5tatives a report conc]n+ ! progress ( ! ,food & ,drug ,adm9i/ration 9 a*iev+ ! goals id5tifi$ 9 ! lett]s describ$ 9 section #bja ( ! 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> #bjah & ea* subsequ5t fiscal ye> = :i* fees are collect$ "u ?is "p1 ! ,secret>y %all prep>e & submit to ! ,committee on ,heal?1 ,education1 ,labor1 & ,p5sions ( ! ,s5ate & ! ,committee on ,en]gy & ,comm]ce ( ! ,h\se ( ,repres5tatives 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 = monograph drug activities = ! fir/ #e fiscal ye>s aft] fiscal ye> #bjbb1 & = ! reau?orization ( ?is "p = su* fiscal ye>s1 ! ,secret>y %all consult )-- 7,a7 ! ,committee on ,heal?1 ,education1 ,labor1 & ,p5sions ( ! ,s5ate2 7,b7 ! ,committee on ,en]gy & ,comm]ce ( ! ,h\se ( ,repres5tatives2 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$]al ,regi/]2 7,c7 provide = a p]iod ( #cj cal5d> days = ! public to provide writt5 comm5ts on su* recomm5dations2 7,d7 hold a meet+ at :i* ! public may pres5t its views on su* recomm5dations2 & 7,e7 aft] consid]ation ( su* public views & comm5ts1 revise su* recomm5dations z necess>y4 7#c7 ,transmittal ( recomm5dations ,n lat] ?an ,janu>y #ae1 #bjbb1 ! ,secret>y %all transmit to ,congress ! revis$ 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