,,ii #aai? ,,congress #a/ ,session ,s4 #bebi ,,9 ,,! ,,s5ate ,,( ,,! ,,unit$ ,,/ates ,july #cj1 #bjbe,mr4 ,hu/$ 7= himself & ,ms4 ,hassan7 introduc$ ! foll[+ bill2 :i* 0 read twice & ref]r$ to ! ,committee on ,heal?1 ,education1 ,labor1 & ,p5sions ,a ,,bill ,to increase ! cl>ity & pr$ictability ( ! process = develop+ applications = ,rx-to-nonprescription swit*es4 #a4 ,increas+ ! cl>ity & pr$ictability ( ! process = develop+ applications = ,rx-to-nonprescription swit*es 7a7 ,9 g5]al ,section #eje7;b7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cee7;b77 is am5d$ by add+ at ! end ! foll[+3 7#g7 ,rx-to-nonprescription swit*es 7,a7 ,meet+s ,any p]son plann+ to submit an application = an ,rx-to-nonprescription swit* may submit to ! ,secret>y a writt5 reque/ = a meet+1 = purposes ( develop+ a plan = su* application t addresses ! pot5tial risks to public heal? ( su* swit* & ! evid5ce necess>y to support su* application1 includ+ ! design ( any necess>y /udies1 & ! =mat & cont5t ( ! plann$ application4 ,! ,secret>y may grant su* a meet+1 z appropriate1 consi/5t ) e/abli%$ proc$ures = grant+ meet+s )1 & provid+ to1 applications "u ?is section4 ,ea* su* meet+ %all be docum5t$ 9 meet+ m9utes4 7,b7 ,guidance 7i7 ,9 g5]al ,n lat] ?an #ah mon?s aft] ! date ( enactm5t ( ?is p>agraph1 ! ,secret>y %all issue guidance to increase ! cl>ity & pr$ictability ( ! process & /&>ds = approval ( applications = nonprescription drugs "u ?is section1 includ+ 9 ! case ( applications = an ,rx-to-nonprescription swit*1 especially ) respect to prescription drugs ) well-e/abli%$ safety pr(iles = :i* an applicant may seek approval = nonprescription use4 7ii7 ,cont5ts ,! guidance "u clause 7i7 %all-- 7,i7 describe h[ publi%$ reports 9 m$ical lit]ature1 any previ\s f9d+ ( safety or effectiv5ess = ! drug "u ?is section1 ! results ( significant human exp]i5ce ) ! drug1 unpubli%$ /udies & o!r data1 & o!r s\rces ( in=mation may be us$ to support an application = a nonprescription drug1 includ+ 9 ! context ( an application = an ,rx-to-nonprescription swit*2 7,,ii7 set =? proc$ures = sponsors to reque/ meet+s describ$ 9 subp>agraph 7,a7 & docum5t ! recomm5dations made 9 su* meet+s2 7,,iii7 describe evid5ti>y expectations to support approval ( an application = a nonprescription drug1 includ+ 9 ! context ( an application = an ,rx-to-nonprescription swit*1 includ+ h[ sponsors c demon/rate t consum]s c appropriately self-select & use ! drug & compreh5d ! nonprescription drug label2 & 7,,iv7 provide recomm5dations = h[ me*anisms1 9 addition to ! requir$ ,drug ,facts ,label1 su* z mobile applications & decisions aids1 c be incorporat$ into ! in=mation submitt$ 9 support ( an application = an ,rx-to-nonprescription swit*4 7,c7 ,plan to engage ) /akehold]s ,n lat] ?an #a ye> aft] ! date ( enactm5t ( ?is p>agraph1 ! ,secret>y %all develop & make publicly available on ! website ( ! ,food & ,drug ,adm9i/ration a plan to engage /akehold]s on /eps & factors = application hold]s & o!r /akehold]s to consid] 9 id5tify+ approv$ prescription drugs t may be promis+ c&idates = applications = an ,rx-to-nonprescription swit*4 7,d7 ,def9ition ,! t]m ,rx-to-nonprescription swit* means ! approval ( an application1 or supplem5tal application1 z applicable1 submitt$ "u ?is section by ! hold] ( an approv$ application = a prescription drug seek+ approval to m>ket su* drug z a nonprescription drug1 includ+ =-- 7i7 a full ,rx-to-nonprescription swit*1 "u :i* a drug previ\sly approv$ = prescription use only is-- 7,i7 approv$ = nonprescription use "u ! same conditions ( use z appli$ to ! drug :5 approv$ = prescription use2 or 7,,ii7 approv$ = nonprescription use subject to "o or m additional conditions = nonprescription use2 & 7ii7 a p>tial ,rx-to-nonprescription swit*1 "u :i* ! drug is approv$ = nonprescription use only "u c]ta9 conditions ( use describ$ 9 ! approv$ label+1 :ile ! drug o!rwise rema9s approv$ = prescription use only4 7,e7 ,rule ( con/ruction ,no?+ 9 ?is p>agraph %all be con/ru$ to-- 7i7 sup]s$e or modify ! au?ority ( ! ,secret>y "u section #eje;,g ) respect to ! regulation ( ,,otc monograph drugs2 or 7ii7 au?orize ! disclosure by ! ,secret>y ( confid5tial comm]cial in=mation or trade secrets4 4 7b7 ,,gao ,report 7#a7 ,9 g5]al ,n lat] ?an #a ye> aft] ! date ( enactm5t ( ?is ,act1 ! ,comptroll] ,g5]al ( ! ,unit$ ,/ates %all submit to ! ,committee on ,heal?1 ,education1 ,labor1 & ,p5sions ( ! ,s5ate & ! ,committee on ,en]gy & ,comm]ce ( ! ,h\se ( ,repres5tatives a report t evaluates-- 7,a7 ! numb] applications = an ,rx-to-nonprescription swit* approv$ dur+ ! p]iod beg9n+ on ,octob] #a1 #bjbb1 & end+ on ! date ( ! report2 7,b7 ! numb] ( drugs = :i* an application = an ,rx-to-nonprescription swit* 0 approv$ dur+ su* p]iod subject to an additional condition = nonprescription use2 7,c7 among ! drugs = :i* an application = a full or p>tial ,rx-to-nonprescription swit* 0 approv$ dur+ su* p]iod1 ! av]age l5g? ( "t f receipt by ! ,food & ,drug ,adm9i/ration ( ! application to ! approval ( su* application2 7,d7 ! numb] ( p>tial ,rx-to-nonprescription swit* applications approv$ dur+ su* p]iod1 & ! numb] ( applications = su* a p>tial swit* n approv$2 7,e7 any b>ri]s to timely & pr$ictable review ( applications = an ,rx-to-nonprescription swit*2 7,f7 engagem5t by ! ,food & ,drug ,adm9i/ration ) public /akehold]s1 includ+ public meet+s or additional activities to support review ( applications = an ,rx-to-nonprescription swit*2 & 7,g7 opportunities = collaboration betwe5 ! ,c5t] = ,drug ,evaluation & ,rese>* & ! ,c5t]s = ,m$ic>e ,m$icaid ,s]vices = ! purpose ( analyz+ heal? insurance claims data = commonly prescrib$ drugs t appe> to be suitable = an ,rx-to-nonprescription swit*4 7#b7 ,def9ition ,9 ?is subsection1 ! t]m ,rx-to-nonprescription swit* has ! mean+ giv5 su* t]m 9 p>agraph 7#g7 ( section #eje7;b7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #bdd7;b771 z add$ by subsection 7a74