,,ii #aae? ,,congress #b;d ,session ,s4 #bffi ,,9 ,,! ,,s5ate ,,( ,,! ,,unit$ ,,/ates ,april #af1 #bjah ,mr4 ,hat* 7= himself1 ,mr4 ,b5net1 ,mr4 ,donnelly1 & ,mr4 ,"y7 introduc$ ! foll[+ bill2 :i* 0 read twice & ref]r$ to ! ,committee on ,heal?1 ,education1 ,labor1 & ,p5sions ,a ,,bill ,to provide = accel]at$ approval ( pa9 & addiction !rapies4 #a4 ,%ort title ,?is ,act may be cit$ z ! ,advanc+ ,innovation 9 ,alt]native ,pa9 & ,addiction ,!rapies ,act4 #b4 ,accel]at$ approval ( pa9 & addiction !rapies 7a7 ,purpose ,x is ! purpose ( ?is section to cl>ify ! appropriate processes = enc\rag+ & exp$it+ ! review ( non-opioid or non-addictive m$ical products to treat *ronic or acute pa9 or sub/ance use disord]s4 7b7 ,draft guidance 7#a7 ,9 g5]al ,n lat] ?an #a ye> aft] ! date ( enactm5t ( ?is ,act1 ! ,secret>y ( ,heal? & ,human ,s]vices 7ref]r$ to 9 ?is section z ! ,secret>y71 act+ ?r\gh ! ,commission] ( ,food & ,drugs1 %all issue draft guidance1 cl>ify+ ! me?ods & processes by :i* ! ,food & ,drug ,adm9i/ration may provide accel]at$ approval = non-opioid or non-addictive drugs develop$ to treat *ronic or acute pa9 or sub/ance use disord]s4 7#b7 ,cont5ts ,! guidance "u p>agraph 7#a7 %all address-- 7,a7 eligibility requirem5ts = su* drugs to receive accel]at$ approval2 7,b7 opportunities = engagem5t ) ! ,food & ,drug ,adm9i/ration ) respect to ! accel]at$ approval pa?way2 7,c7 consid]ations = diff]5t types ( pa9 & product me*anism ( action2 & 7,d7 pot5tial crit]ia = novel surrogate or int]m$iate cl9ical endpo9ts or biom>k]s to assess pa94 7c7 ,f9al guidance ,n lat] ?an #f mon?s aft] ! close ( ! p]iod = public comm5t on ! draft guidance "u subsection 7b71 ! ,secret>y %all f9alize su* guidance4 7d7 ,data 9 p]=mance reports 7#a7 ,9 g5]al ,z a compon5t ( ! annual p]=mance report "u section #gcf;,b7a7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;h-#b7;a771 ! ,secret>y %all include in=mation1 z appropriate1 on policies & processes ( ! ,division ( ,ane/hesia1 ,analgesia1 & ,addiction ,products ( ! ,food & ,drug ,adm9i/ration 7ref]r$ to 9 ?is section z ! ,,daaap7 = ! accel]at$ approval pa?way ) respect to drugs develop$ to treat pa9 or sub/ance use disord]s1 dur+ ! previ\s fiscal ye>4 7#b7 ,cont5ts ,in=mation submitt$ z a "p ( ! p]=mance reports "u section #gcf;,b7a7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act may address-- 7,a7 ! numb] ( reque/s = accel]at$ approval submitt$ to ! ,,daaap = non-opioid or non-addictive m$ical products2 7,b7 ! numb] ( applications = accel]at$ approval t ! ,,daaap grant$1 & a description ( ! common reasons = grant+ applications = accel]at$ approval2 7,c7 ! numb] ( applications = accel]at$ approval t ! ,,daaap d5i$1 & a description ( ! common reasons = d5y+ applications = accel]at$ approval2 7,d7 ! p]c5tage ( products 9 su* review division :i* met ! review goals id5tifi$ 9 ! lett]s describ$ 9 section #aja7;b7 ( ! ,prescription ,drug ,us] ,fee ,am5dm5ts ( #bjag 7,public ,law #aae-eb72 7,e7 ag5cy ef=ts to ensure consi/5cy across review divisions 9 ! metrics & processes by :i* new drug applications = non-addictive or non-opioid products int5d$ to treat pa9 are review$2 7,f7 a discussion & summ>y ( ! common reasons = applications :i* did n meet ! review goals id5tifi$ 9 ! lett]s describ$ 9 section #aja7;b7 ( ! ,prescription ,drug ,us] ,fee ,am5dm5ts ( #bjag 7,public ,law #aae-eb71 z applicable & appropriate2 & 7,g7 recomm5dations to bett] enable utilization ( ! accel]at$ approval pa?way4 #c4 ,break?r\gh !rapy /atus = pa9 & addiction !rapies 7a7 ,draft guidance 7#a7 ,9 g5]al ,n lat] ?an #a ye> aft] ! date ( enactm5t ( ?is ,act1 ! ,secret>y ( ,heal? & ,human ,s]vices 7ref]r$ to 9 ?is section z ! ,secret>y71 act+ ?r\gh ! ,commission] ( ,food & ,drugs1 %all issue draft guidance1 cl>ify+ ! me?ods & processes by :i* ! ,food & ,drug ,adm9i/ration may provide a break?r\gh !rapy designation = non-opioid or non-addictive drugs or devices develop$ to treat *ronic or acute pa9 or sub/ance use disord]s4 7#b7 ,cont5ts ,! guidance "u p>agraph 7#a7 %all address-- 7,a7 eligibility requirem5ts = su* drugs & devices to receive break?r\gh !rapy designation2 7,b7 opportunities = engagem5t ) ! ,food & ,drug ,adm9i/ration ) respect to ! break?r\gh !rapy pa?way2 7,c7 specific actions to ensure t ! design ( ! cl9ical trials is z effici5t z practicable1 :5 applicable & sci5tifically appropriate1 = su* drugs & devices2 & 7,d7 ! application ( organizational commitm5t ( ! ,food & ,drug ,adm9i/ration to facilitat+ break?r\gh designation = qualifi$ drugs & devices1 includ+ involvem5t ( s5ior manag]s ( ! ,food & ,drug ,adm9i/ration = su* drugs & devices4 7b7 ,f9al guidance ,n lat] ?an #f mon?s aft] ! close ( ! p]iod = public comm5t on ! draft guidance "u subsection 7a71 ! ,secret>y %all f9alize su* guidance4 7c7 ,data 9 p]=mance reports 7#a7 ,9 g5]al ,z a compon5t ( ! p]=mance reports "u sections #gcf;,b7a7 & #gch;,a7a7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;h-#b1 #cgi;j-#a71 ! ,secret>y %all include in=mation1 z appropriate1 on policies & processes ( ! ,division ( ,ane/hesia1 ,analgesia1 & ,addiction ,products ( ! ,food & ,drug ,adm9i/ration 7ref]r$ to 9 ?is section z ! ,,daaap7 = ! break?r\gh !rapy pa?way1 ) respect to drugs & devices develop$ to treat *ronic or acute pa9 or sub/ance use disord]s1 dur+ ! previ\s fiscal ye>4 7#b7 ,cont5ts ,in=mation provid$ z a compon5t ( ! p]=mance reports "u sections #gcf;,b7a7 & #gch;,a7a7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act may address-- 7,a7 ! numb] ( reque/s = break?r\gh !rapy designation submitt$ to ! ,,daaap2 7,b7 ! numb] ( applications = break?r\gh !rapy designation t ! ,,daaap grant$1 & a description ( ! common reasons = grant+ applications = break?r\gh !rapy designation2 7,c7 ! numb] ( applications = break?r\gh !rapy designation t ! ,,daaap d5i$1 & a description ( ! common reasons = d5y+ applications = break?r\gh !rapy designation2 & 7,d7 recomm5dations to bett] enable utilization ( ! break?r\gh !rapy designation pa?way = non-addictive or non-opioid products int5d$ to treat pa94