,,ii #aah? ,,congress #b;d ,session ,s4 #cgcc ,,9 ,,! ,,s5ate ,,( ,,! ,,unit$ ,,/ates ,febru>y #e1 #bjbd,mr4 ,pet]s 7= himself & ,ms4 ,/ab5[7 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 e/abli%m5t ,! t]m human cell & tissue e/abli%m5t means an e/abli%m5t 7z def9$ 9 section #abga4c7;b7 ( title #ba1 ,code ( ,f$]al ,regulations 7or a successor regulation77 regulat$ by ! ,c5t] = ,biologics ,evaluation & ,rese>* "u "p #abga ( title #ba1 ,code ( ,f$]al ,regulations4 7#b7 ,human cell & tissue products ,! t]m human cell & tissue products has ! mean+ giv5 ! t]m human cells1 tissues1 or cellul> or tissue-bas$ products 9 section #abga4c7;d7 ( title #ba1 ,code ( ,f$]al ,regulations 7or a successor regulation74 7#c7 ,secret>y ,! t]m ,secret>y means ! ,secret>y ( ,heal? & ,human ,s]vices4 #c4 ,human cell & tissue products transplant public aw>5ess campaign 7a7 ,9 g5]al ,! ,secret>y %all conduct a national1 evid5ce-bas$ education campaign to increase public & heal? c>e provid] aw>5ess reg>d+ ! pot5tial risks & b5efits ( human cell & tissue products transplants4 7b7 ,consid]ation ( advice ( /akehold] exp]ts ,! ,secret>y %all develop ! education campaign "u subsection 7a7 aft] tak+ into consid]ation ! advice ( /akehold] exp]ts1 includ+ ! ,c5t]s = ,disease ,control & ,prev5tion & pr(essional associations t repres5t /akehold]s ( human cell & tissue e/abli%m5ts t manufacture human cell & tissue products ) ! highe/ risk ( transmitt+ infections to _! pati5ts4 7c7 ,grants 7#a7 ,9 g5]al ,! ,secret>y may aw>d grants to nonpr(it organizations to c>ry out activities describ$ 9 p>agraph 7#b74 7#b7 ,use ( funds ,a recipi5t ( a grant "u p>agraph 7#a7 %all use ! grant funds-- 7,a7 to increase ! k & aw>5ess ( ! public ab\t ! pot5tial risks & b5efits ( human cell & tissue products transplants1 includ+ ! risks t su* transplants may lead to infecti\s diseases1 includ+ tub]culosis1 lat5t tub]culosis infection1 & sepsis2 or 7,b7 to increase ! k & aw>5ess ( heal? c>e provid]s & heal? c>e lead]s ab\t ! pot5tial risks & b5efits ( human cell & tissue products transplants1 includ+ ! risks t su* transplants may lead to infecti\s diseases1 includ+ tub]culosis1 lat5t tub]culosis infection1 & sepsis4 7d7 ,m$ia campaigns 7#a7 ,9 g5]al ,9 c>ry+ out ! education campaign "u subsection 7a71 ! ,secret>y1 aft] tak+ into consid]ation ! advice ( /akehold] exp]ts1 may aw>d grants to1 or ent] into contracts )1 entities to e/abli% national multim$ia campaigns to increase public & heal? c>e provid] aw>5ess reg>d+ ! pot5tial risks ( human cell & tissue products transplants4 7#b7 ,inclusions ,! multim$ia campaigns "u p>agraph 7#a7 may include adv]tis+ ?r\gh television1 radio1 pr9t m$ia1 billbo>ds1 po/]s1 all =ms ( exi/+ & em]g+ social network+ m$ia1 o!r int]net m$ia1 & any o!r m$ium det]m9$ appropriate by ! ,secret>y4 #d4 ,civil p5alties = violation ( requirem5ts = human cell & tissue products 7a7 ,9 g5]al ,any p]son :o violates a requirem5t ( section #cfa ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bfd7 or "p #abga ( title #ba1 ,code ( ,f$]al ,regulations 7or successor regulations7 ) respect to human cell or tissue products %all be liable to ! ,unit$ ,/ates = a civil p5alty 9 an am\nt n to exce$ ! sum (-- 7#a7 7,a7 #bj1jjj = ea* violation2 or 7,b7 #bj1jjj = ea* day ( a cont9u+ violation2 & 7#b7 an am\nt equal to ! retail value ( ! human cell & tissue products t are ! subject ( ! violation4 7b7 ,maximum p5alty ,! total civil p5alty "u subsection 7a7 %all n exce$ #aj1jjj1jjj = all su* violations adjudicat$ 9 a s+le proce$+4 #e4 ,report to ,congress ,n lat] ?an #b ye>s aft] ! date ( enactm5t ( ?is ,act1 ! ,secret>y %all submit to ,congress a report t describes actions ,congress & ! ,food & ,drug ,adm9i/ration c\ld take to improve ! safety ( human cell & tissue products1 includ+-- 7#a7 an exam9ation ( exi/+ regulations & guidance relat+ to human cell & tissue products2 7#b7 docum5tation ( ! numb] ( human cell & tissue e/abli%m5ts t h regi/]$ ) ! ,food & ,drug ,adm9i/ration s9ce #aiih2 7#c7 h[ (t5 ! ,food & ,drug ,adm9i/ration has inspect$ human cell & tissue e/abli%m5ts s9ce #aiih1 includ+ a comp>ison ( ! inspection rates = blood e/abli%m5ts & ,s\rce ,plasma e/abli%m5ts ) ! inspection rates = su* human cell & tissue e/abli%m5ts1 pot5tial causes ( decl9es 9 su* inspections1 if applicable1 & recomm5dations to increase ,food & ,drug ,adm9i/ration res\rces1 if applicable2 & 7#d7 recomm5dations on pot5tial guidance or regulations t c\ld be issu$ or promulgat$1 z applicable1 to improve donor scre5+ = human cell & tissue products4 #f4 ,review & update ( exi/+ guidance ,! ,secret>y1 act+ ?r\gh ! ,commission] ( ,food & ,drugs1 %all-- 7#a7 n lat] ?an #a ye> aft] ! date ( enactm5t ( ?is ,act1 initiate an int]nal review ( exi/+ guidance = det]m9+ eligibility ( donors ( human cell & tissue products2 & 7#b7 n lat] ?an #c ye>s aft] ! date ( enactm5t ( ?is ,act1 issue updat$ guidance = det]m9+ eligibility ( donors ( human cell & tissue products to comply ) "p #abga ( title #ba1 ,code ( ,f$]al ,regulations 7or successor regulations71 includ+ compliance 9 det]m9+ donor eligibility 9 accordance ) subp>t ,c ( "p #abga ( title #ba1 ,code ( ,f$]al ,regulations 7or successor regulations74