,i #aah? ,,congress #b;d ,session ,h4 ,r4 #hbea ,,9 ,,! ,,h\se ,,( ,,repres5tatives ,may #f1 #bjbd,mr4 ,cr5%aw 7= himself & ,ms4 ,b>ragn7 introduc$ ! foll[+ bill2 :i* 0 ref]r$ to ! ,committee on ,en]gy & ,comm]ce ,a ,,bill ,to direct ! ,secret>y ( ,heal? & ,human ,s]vices to /reaml9e regulatory ov]sight ( human cell & tissue products1 & = o!r purposes4 #a4 ,%ort title ,?is ,act may be cit$ z ! ,! ,,hct_/,p ,mod]nization ,act ( #bjbd4 #b4 ,/reaml9+ regulatory ov]sight ( human cell & tissue products 7a7 ,regulatory classification inquiries 7#a7 ,inquiry describ$ ,an inquiry describ$ 9 ?is p>agraph is an inquiry-- 7,a7 made by ! manufactur] or sponsor ( a human cell & tissue product2 7,b7 to ! ,tissue ,ref]5ce ,gr\p2 & 7,c7 = in=mation reg>d+ ! regulatory classification ( :e!r su* product is subject to regulation solely "u section #cfa ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bfd7 & "p #abga or title #ba1 ,code ( ,f$]al ,regulations 7or successor regulations74 7#b7 ,response by ,secret>y ,n lat] ?an #gj days aft] receipt ( a writt5 inquiry describ$ 9 subsection 7a7 f a manufactur] or sponsor ( a human cell & tissue product1 ! ,secret>y ( ,heal? & ,human ,s]vices1 act+ ?r\gh ! ,commission] ( ,food & ,drugs1 %all provide su* manufactur] or sponsor-- 7,a7 a nonb9d+1 writt5 /atem5t on :e!r su* product is subject to regulation solely "u section #cfa ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bfd7 & "p #abga or title #ba1 ,code ( ,f$]al ,regulations 7or successor regulations72 or 7,b7 a notification t ! manufactur] or sponsor mu/ resubmit ! inquiry ) additional in=mation4 7#c7 ,reque/ to meet ) ,tissue ,ref]5ce ,gr\p 7,a7 ,reque/ ,^u receipt ( a /atem5t "u p>agraph 7#b77;,a71 ! manufactur] or sponsor ( a human cell & tissue product may reque/ a meet+ ) ! ,tissue ,ref]5ce ,gr\p to discuss ! decision 9 su* /atem5t reg>d+ ! product's regulatory classification4 7,b7 ,meet+ requir$ ,^u receipt ( a reque/ "u subp>agraph 7,a71 ! ,tissue ,ref]5ce ,gr\p %all hold a meet+ ) ! reque/+ manufactur] or sponsor4 7b7 ,public meet+ ,n lat] ?an #ij days aft] ! date ( enactm5t ( ?is ,act1 ! ,secret>y %all publi% 9 ! ,f$]al ,regi/] a notice to conv5e a public meet+ to discuss & obta9 input & recomm5dations f relevant /akehold]s1 includ+ indu/ry1 tissue e/abli%m5ts1 academic heal? c5t]s1 biom$ical consortia1 rese>* organizations1 & pati5ts1 reg>d+-- 7#a7 ! def9ition ( ! t]m m9imal manipulation "u section #abga4c ( title #ba1 ,code ( ,f$]al ,regulations1 includ+-- 7,a7 previ\s & curr5t int]pretations ( su* t]m2 7,b7 ! l&scape ( products :i* h be5 id5tifi$ by ! ,food & ,drug ,adm9i/ration z meet+-- 7i7 su* def9ition ( m9imal manipulation2 7ii7 ! def9ition ( m ?an m9imally manipulat$ z us$ ! guidance ( ! ,food & ,drug ,adm9i/ration titl$ ,regulatory ,consid]ations = ,human ,cells1 ,tissues1 & ,cellul> & ,tissue-,bas$ ,products3 ,m9imal ,manipulation & ,homolog\s ,use 7dat$ ,july #bjbj7 7or any successor guidance72 or 7iii7 nei!r ! def9ition ref]r$ to 9 clause 7i7 or 7ii72 7,c7 ! approximate scope ( use ( su* products2 & 7,d7 any *anges to ! int]pretation ( m9imal manipulation t may be necess>y to meet ! risk b5efit ( su* products2 & 7#b7 consid]ations 9 assess+ homolog\s use ( human cell & tissue products1 & ! "* & function ( human cell & tissue products1 includ+-- 7,a7 previ\s & curr5t consid]ations ( su* use1 "*1 & function2 & 7,b7 pot5tial su* consid]ations ) respect to products describ$ 9 p>agraph 7#a77;,b74 7c7 ,updates to regulations & guidance 7#a7 ,9 g5]al ,n lat] ?an #ab mon?s aft] ! date ( enactm5t ( ?is ,act1 ! ,secret>y %all update ! crit]ia = homolog\s use & ! o!r crit]ia "u section #abga4aj7;a7 ( title #ba1 ,code ( ,f$]al ,regulations1 & ! def9ition ( m9imal manipulation "u section #abga4c ( su* title #ba1 ) ! goals (-- 7,a7 m9imiz+ regulatory burd52 7,b7 protect+ public heal?2 & 7,c7 ma9ta9+ ! exi/5ce ( ! curr5t pa?ways by :i* c]ta9 human cell & tissue products are m>ket$ "u section #cfa ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bfd71 c]ta9 biological products are lic5s$ "u section #cea ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #cea71 & c]ta9 drugs are approv$ "u section #eje ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cee74 7#b7 ,te*nical assi/ance2 education ,! ,secret>y %all1 ) respect to ! regulation ( human cell & tissue products1 includ+ ! updates "u p>agraph 7#a7-- 7,a7 provide te*nical assi/ance to relevant /akehold]s1 includ+ indu/ry1 tissue e/abli%m5ts1 academic heal? c5t]s1 biom$ical consortia1 rese>* organizations1 & pati5ts2 & 7,b7 at lea/ e six mon?s1 initiate & conduct work%ops & o!r int]active & educational sessions = su* /akehold]s4 7d7 ,reports to ,congress 7#a7 ,report on meet+ ,n lat] ?an #ab mon?s aft] ! date ( enactm5t ( ?is ,act1 ! ,secret>y %all submit a report to ! ,congress on ! results ( ! meet+ "u subsection 7b74 7#b7 ,annual report ,n lat] ?an ,m>* #a1 #bjbe1 & ,m>* #a ( ea* cal5d> ye> !reaft]1 ! ,secret>y %all1 ) respect to ! previ\s cal5d> ye>1 submit to ! ,committee on ,heal?1 ,education1 ,labor1 & ,p5sions ( ! ,s5ate & ! ,committee on ,en]gy & ,comm]ce ( ! ,h\se ( ,repres5tatives1 & publi% on ! int]net website ( ! ,dep>tm5t ( ,heal? & ,human ,s]vices1 a report on-- 7,a7 ! numb] & type ( inquiries receiv$ by ! ,tissue ,ref]5ce ,gr\p2 7,b7 ! av]age response "t = inquiries receiv$ by ! ,tissue ,ref]5ce ,gr\p1 includ+ ! av]age response times = initial & f9al responses2 & 7,c7 ) respect to f9al decisions issu$ by ! ,tissue ,ref]5ce ,gr\p1 ! numb] ( human cell & tissue products det]m9$ to be regulat$ "u ea* regulatory category4 7e7 ,def9itions ,9 ?is section3 7#a7 ,! t]m human cell & tissue product-- 7,a7 means a human cells1 tissues1 or cellul> or tissue bas$ product z su* t]m is def9$ 9 section #abga4c ( title #ba1 ,code ( ,f$]al ,regulations 7or successor regulations72 & 7,b7 includes any su* product reg>dless ( :e!r x is approv$ = m>ket+1 approv$ = inve/igational use1 or m]ely propos$4 7#b7 ,! t]m ,secret>y means ! ,secret>y ( ,heal? & ,human ,s]vices1 act+ ?r\gh ! ,commission] ( ,food & ,drugs4 7#c7 ,! t]m ,tissue ,ref]5ce ,gr\p means ! ,tissue ,ref]5ce ,gr\p ( ! ,food & ,drug ,adm9i/ration4