,,ii #aai? ,,congress #b;d ,session ,s4 #dhhe ,,9 ,,! ,,s5ate ,,( ,,! ,,unit$ ,,/ates ,june #bd1 #bjbf,mr4 ,pet]s 7= himself & ,mr4 ,m>%all7 introduc$ ! foll[+ bill2 :i* 0 read twice & ref]r$ to ! ,committee on ,heal?1 ,education1 ,labor1 & ,p5sions ,a ,,bill ,to require ! ,secret>y ( ,heal? & ,human ,s]vices to conduct a national1 evid5ce-bas$ education campaign to increase public & heal? c>e provid] aw>5ess reg>d+ ! pot5tial risks & b5efits ( human cell & tissue products transplants1 & = o!r purposes4 #a4 ,%ort title ,?is ,act may be cit$ z ! ,%&ra ,eis5ga ,human ,cell & ,tissue ,product ,safety ,act4 #b4 ,def9itions ,9 ?is ,act3 7#a7 ,human cell & tissue product ,! t]ms human cell & tissue product & human cell & tissue products h ! mean+ giv5 ! t]m human cells1 tissues1 or cellul> or tissue-bas$ products 9 section #abga4c7;d7 ( title #ba1 ,code ( ,f$]al ,regulations 7or successor regulations74 7#b7 ,secret>y ,! t]m ,secret>y means ! ,secret>y ( ,heal? & ,human ,s]vices4 7#c7 ,tissue ,ref]5ce ,gr\p ,! t]m ,tissue ,ref]5ce ,gr\p means ! ,tissue ,ref]5ce ,gr\p ( ! ,food & ,drug ,adm9i/ration4 #c4 ,human cell & tissue products transplant public aw>5ess campaign ,! ,secret>y %all support ! developm5t & dissem9ation ( educational mat]ials to in=m heal? c>e pr(essionals & o!r appropriate pr(essionals ab\t issues surr\nd+-- 7#a7 organ1 tissue1 & eye donation1 includ+ evid5ce-bas$ me?ods to approa* pati5ts & _! families2 7#b7 ! availability ( any donor scre5+ te/s2 & 7#c7 o!r relevant aspects ( donation4 #d4 ,civil p5alties = violation ( requirem5ts = human cell & tissue products ,section #cfh ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bga7 is am5d$ by add+ at ! end ! foll[+3 7d7 7#a7 ,any p]son :o1 on or aft] ! date ( ! enactm5t ( ! ,%&ra ,eis5ga ,human ,cell & ,tissue ,product ,safety ,act1 violates a requirem5t ( subp>t ,c or ,d ( section #abga ( title #ba1 ,code ( ,f$]al ,regulations 7or successor regulations71 ) respect to human cell or tissue products regulat$ "u section #cfa %all be liable to ! ,unit$ ,/ates = a civil p5alty 9 an am\nt n to exce$ ! sum (-- 7,a7 7i7 #bj1jjj = ea* violation2 & 7ii7 9 ! case ( a violation t cont9ues aft] ! ,secret>y provides writt5 notice to su* p]son1 #bj1jjj = ea* subsequ5t day on :i* ! violation cont9ues2 & 7,b7 an am\nt equal to ! retail value ( ! human cell & tissue products t are ! subject ( ! violation4 7#b7 ,! total civil p5alty "u p>agraph 7#a7 may n exce$ #aj1jjj1jjj = all su* violations adjudicat$ 9 a s+le proce$+4 7#c7 ,9 ?is subsection1 ! t]m human cell & tissue products has ! mean+ giv5 ! t]m human cells1 tissues1 or cellul> or tissue-bas$ products 9 section #abga4c7;d7 ( title #ba1 ,code ( ,f$]al ,regulations 7or successor regulations74 4 #e4 ,/reaml9+ regulatory ov]sight ( human cell & tissue products 7a7 ,in=mation on human cell & tissue products 7#a7 ,website ,! ,secret>y1 act+ ?r\gh ! ,commission] ( ,food & ,drugs1 %all publi% on ! public website ( ! ,food & ,drug ,adm9i/ration-- 7,a7 educational mat]ials ab\t ! ,tissue ,ref]5ce ,gr\p2 & 7,b7 be/ practices = obta9+ a timely1 accurate recomm5dation reg>d+ human cell & tissue products f ! ,tissue ,ref]5ce ,gr\p4 7#b7 ,public in=mation ,n lat] ?an #a ye> aft] ! date ( ! enactm5t ( ?is ,act1 & annually = ! subsequ5t #c ye>s1 ! ,secret>y1 act+ ?r\gh ! ,commission] ( ,food & ,drugs1 %all publi% on ! public website ( ! ,food & ,drug ,adm9i/ration-- 7,a7 ! numb] ( human cell & tissue e/abli%m5ts t regi/]$ ) ! ,food & ,drug ,adm9i/ration on or aft] ,janu>y #a1 #bjai2 7,b7 ! numb] ( inspections conduct$ by ! ,food & ,drug ,adm9i/ration ( human cell & tissue e/abli%m5ts on or aft] ,janu>y #a1 #bjai1 includ+ a comp>ison ( ! numb] ( inspections = blood e/abli%m5ts ) ! numb] ( inspections = su* human cell & tissue e/abli%m5ts2 7,c7 ! numb] & type ( inquiries to ! ,tissue ,ref]5ce ,gr\p 9 ! prec$+ ye>2 & 7,d7 ! av]age response "t = submissions to ! ,tissue ,ref]5ce ,gr\p 9 ! prec$+ ye>1 includ+ av]age initial & f9al response "t4 7#c7 ,education ,! ,secret>y1 act+ ?r\gh ! ,commission] ( ,food & ,drugs1 %all1 ) respect to ! regulation ( human cell & tissue products-- 7,a7 provide in=mation to relevant /akehold]s1 includ+ indu/ry1 tissue e/abli%m5ts1 academic heal? c5t]s1 biom$ical consortia1 rese>* organizations1 & pati5ts2 & 7,b7 conduct work%ops & o!r int]active & educational sessions = su* /akehold]s to help support regulatory pr$ictability & sci5tific advancem5t1 z appropriate4 7b7 ,human cell & tissue product sci5tific & regulatory updates ,section #cbje ( ! ,food & ,drug ,omnibus ,re=m ,act ( #bjbb 7title ,,iii ( division ,,ff ( ,public ,law #aag-cbh7 is am5d$ by /rik+ be/ practices & all t foll[s ?r\gh o!r cellul> !rapies & ins]t+ be/ practices on g5]at+ sci5tific data necess>y to fur!r facilitate ! developm5t ( c]ta9 human cell-1 tissue-1 & cellul>-bas$ m$ical products 7& ! late/ sci5tific in=mation ab\t su* products71 namely1 /em cell & o!r cellul> !rapies4 7c7 ,public docket ,n lat] ?an #fj days aft] ! date ( ! enactm5t ( ?is ,act1 ! ,secret>y %all e/abli% a public docket to receive writt5 comm5ts relat$ to-- 7#a7 ! approa*es recomm5d$ = discussion dur+ ! public work%op describ$ 9 section #cbje ( ! ,food & ,drug ,omnibus ,re=m ,act ( #bjbb 7title ,,iii ( division ,,ff ( ,public ,law #aag-cbh72 & 7#b7 mod]niz+ ! regulation ( human cell & tissue products1 includ+ consid]ations associat$ ) assess+ m9imal manipulation & homolog\s use 7z su* t]ms are def9$ 9 section #abga4c ( title #ba1 ,code ( ,f$]al ,regulations 7or successor regulations77 ( human cell & tissue products4 7d7 ,report to ,congress ,n lat] ?an ,septemb] #cj1 #bjbf1 ! ,secret>y %all summ>ize ! approa*es discuss$ 9 ! public work%op describ$ 9 section #cbje ( ! ,food & ,drug ,omnibus ,re=m ,act ( #bjbb 7title ,,iii ( division ,,ff ( ,public ,law #aag-cbh7 & ! public docket describ$ 9 subsection 7c71 & develop recomm5dations reg>d+ ! regulation ( human cell & tissue products1 includ+ provisions "u sections #abga4aj7;a7 & #abga4c ( title #ba1 ,code ( ,f$]al ,regulations1 tak+ into acc\nt-- 7#a7 regulatory burd52 7#b7 sci5tific developm5ts2 7#c7 access to human cell & tissue products regulat$ "u section #cfa ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bfd72 & 7#d7 protect+ public heal?4