,,ii #aac? ,,congress #b;d ,session ,s4 #babf ,,9 ,,! ,,s5ate ,,( ,,! ,,unit$ ,,/ates ,m>* #ac1 #bjad ,mrs4 ,box] 7= h]self & ,mr4 ,kirk7 introduc$ ! foll[+ bill2 :i* 0 read twice & ref]r$ to ! ,committee on ,heal?1 ,education1 ,labor1 & ,p5sions ,a ,,bill ,to laun* a national /rategy to support reg5]ative m$ic9e ?r\gh ! e/abli%m5t ( a ,reg5]ative ,m$ic9e ,coord9at+ ,c\ncil1 & = o!r purposes4 #a4 ,%ort title ,?is ,act may be cit$ z ! ,reg5]ative ,m$ic9e ,promotion ,act ( #bjad4 #b4 ,f9d+s ,congress f9ds ! foll[+3 7#a7 ,reg5]ative m$ic9e has ! pot5tial to treat _m *ronic diseases1 promote economic gr[?1 & r$uce heal? c>e sp5d+ 9 ! ,unit$ ,/ates4 7#b7 ,reg5]ative m$ic9e products h already successfully treat$ num]\s heal? conditions & h ! pot5tial to provide cures1 treatm5ts & diagno/ics = a range ( diseases & disabilities includ+ diabetes1 sp9al cord injury1 he>t disease1 /roke1 v>i\s =ms ( canc]1 & o!r age-relat$ conditions t repres5t a huge quality ( life1 social1 & economic burd5 on society4 7#c7 ,a ,unit$ ,/ates national /rategy on reg5]ative m$ic9e is critical to ensure t ?is te*nology fulfills its pot5tial to cure & treat diseases & disabilities1 r$uce ov]all heal? c>e sp5d+1 & promote economic gr[?4 7#d7 ,! ,dep>tm5t ( ,def5se has /at$ t reg5]ative m$ic9e has ! pot5tial to treat _m battlefield injuries su* z burns1 t x has ! pot5tial to heal w\nds )\t sc>r+1 & t x has ! pot5tial to be us$ = crani(acial recon/ruction1 limb recon/ruction1 reg5]ation1 & transplantation4 7#e7 ,! ,dep>tm5t ( ,heal? & ,human ,s]vices & ! ,multi-,ag5cy ,tissue ,eng9e]+ ,sci5ce ,int]ag5cy ,work+ ,gr\p h endors$ a national initiative to support rese>* & product developm5t 9 reg5]ative m$ic9e4 7#f7 ,! ,dep>tm5t ( ,heal? & ,human ,s]vices has said ! pot5tial b5efits ( reg5]ative m$ic9e 9 improv$ heal? c>e & economic sav+s are enorm\s4 ,/ates t h inve/$ 9 reg5]ative m$ic9e h exp]i5c$ economic gr[? & see future gr[? pot5tial1 includ+ an increase 9 biote* employm5t1 payroll increases1 & proportional impacts on tax receipts4 #c4 ,report on ongo+ ,f$]al programs & activities reg>d+ reg5]ative m$ic9e ,n lat] ?an #ij days aft] ! date ( ! enactm5t ( ?is ,act1 ! ,comptroll] ,g5]al ( ! ,unit$ ,/ates %all provide = ! completion1 & submission to ,congress1 ( a report id5tify+ all ongo+ ,f$]al programs & activities reg>d+ reg5]ative m$ic9e4 #d4 ,e/abli%m5t ( ,reg5]ative ,m$ic9e ,coord9at+ ,c\ncil 7a7 ,e/abli%m5t ,! ,secret>y ( ,heal? & ,human ,s]vices %all e/abli%1 9 ! ,(fice ( ! ,secret>y1 a ,reg5]ative ,m$ic9e ,coord9at+ ,c\ncil 79 ?is section ref]r$ to z ! ,c\ncil74 7b7 ,composition ,! ,c\ncil %all be compos$ ( ! foll[+3 7#a7 ,! ,secret>y ( ,comm]ce4 7#b7 ,! ,secret>y ( ,def5se4 7#c7 ,! ,secret>y ( ,heal? & ,human ,s]vices4 7#d7 ,! ,secret>y ( ! ,treasury4 7#e7 ,! ,secret>y ( ,vet]ans ,affairs4 7#f7 ,! ,adm9i/rator ( ! ,ag5cy = ,heal?c>e ,rese>* & ,quality4 7#g7 ,! ,adm9i/rator ( ! ,c5t]s = ,m$ic>e ,m$icaid ,s]vices4 7#h7 ,! ,commission] ( ,food & ,drugs4 7#i7 ,! ,director ( ! ,national ,in/itutes ( ,heal?4 7#aj7 ,! ,director ( ! ,national ,in/itutes ( ,/&>ds & ,te*nology4 7#aa7 ,su* o!r memb]s z may be appo9t$ by ! ,secret>y ( ,heal? & ,human ,s]vices4 7c7 ,*air ,! ,secret>y ( ,heal? & ,human ,s]vices %all be ! ,*air ( ! ,c\ncil4 7d7 ,memb]s appo9t$ by ,secret>y ,! memb]s ( ! ,c\ncil appo9t$ by ! ,secret>y ( ,heal? & ,human ,s]vices "u subsection 7b77#aa7 %all include heal? insur]s1 reg5]ative m$ic9e rese>*]s f academic in/itutions1 pati5t advocates1 p]sons ) exp]tise 9 drug discov]y1 p]sons ) exp]tise 9 drug developm5t1 p]sons ) exp]tise 9 basic rese>*1 p]sons ) exp]tise 9 translational rese>*1 p]sons ) exp]tise 9 m$ical device developm5t1 p]sons ) exp]tise 9 biomat]ials1 & p]sons ) exp]tise 9 cl9ical rese>*4 7e7 ,functions ,! ,c\ncil %all-- 7#a7 prep>e1 & keep up-to-date1 a national /rategy to support rese>* into reg5]ative m$ic9e & enable ! developm5t ( drugs1 biological products1 m$ical devices1 & biomat]ials = use 9 reg5]ative m$ic9e2 7#b7 develop national goals = reg5]ative m$ic9e rese>* & product developm5t2 7#c7 prep>e a plan specify+ priorities = rese>* into reg5]ative m$ic9e2 7#d7 id5tify s\rces ( fund+ = rese>* into reg5]ative m$ic9e2 7#e7 id5tify areas :]e su* fund+ is inadequate or duplicative2 7#f7 make recomm5dations reg>d+ ,f$]al regulatory1 reimbursem5t1 & o!r policies t w support developm5t & m>ket+ ( reg5]ative m$ic9e products2 7#g7 develop cons5sus /&>ds reg>d+ sci5tific issues critical to regulatory approval ( reg5]ative m$ic9e products2 & 7#h7 det]m9e ! ne$ = e/abli%+ c5t]s ( excell5ce or consortia to fur!r advance reg5]ative m$ic9e4 7f7 ,transp>5cy2 report+ requirem5ts 7#a7 ,transp>5cy ,! ,c\ncil %all adopt proc$ures to ensure ! receipt ( public input1 su* z hold+ public /akehold] meet+s or creat+ advisory bo>ds4 7#b7 ,annual reports ,! ,c\ncil %all submit an annual report on its activities to ,congress1 ! ,director ( ! ,national ,in/itutes ( ,heal?1 & ! ,commission] ( ,food & ,drugs4 ,ea* su* report %all-- 7,a7 provide details on progress 9 meet+ goals id5tifi$ by ! ,c\ncil = reg5]ative m$ic9e2 7,b7 provide recomm5dations reg>d+ fund+1 regulatory1 or o!r policies to a*ieve reg5]ative m$ic9e goals id5tifi$ by ! ,c\ncil2 7,c7 id5tify reg5]ative m$ic9e products curr5tly on ! m>ket & ^? 9 developm5t2 7,d7 id5tify reg5]ative m$ic9e rese>* & te*nological advances & discov]ies t occurr$ 9 ! previ\s ye>2 & 7,e7 assess ! impact ( reg5]ative m$ic9e on ! ,nation's economy1 includ+ ) respect to-- 7i7 ! numb] ( p employ$ 9 companies or rese>* in/itutions work+ 9 reg5]ative m$ic9e2 7ii7 ! numb] ( companies pursu+ reg5]ative m$ic9e products2 & 7iii7 increases 9 tax rev5ues4