,,ii #aaf? ,,congress #b;d ,session ,s4 #ddbg ,,9 ,,! ,,s5ate ,,( ,,! ,,unit$ ,,/ates ,augu/ #d1 #bjbj,ms4 ,hassan 7= h]self1 ,mr4 ,braun1 & ,ms4 ,murk[ski7 introduc$ ! foll[+ bill2 :i* 0 read twice & ref]r$ to ! ,committee on ,heal?1 ,education1 ,labor1 & ,p5sions ,a ,,bill ,to provide = transp>5cy 9 em]g5cy use au?orization ( vacc9e products1 & = o!r purposes4 #a4 ,%ort title ,?is ,act may be cit$ z ! ,safe ,au?orization = ,vacc9es dur+ ,em]g5cies ,act or ! ,,save ,act4 #b4 ,transp>5cy 9 em]g5cy use au?orization ( vacc9e products 7a7 ,em]g5cy use au?orizations 7#a7 ,9 g5]al ,section #efd ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;bbb-#c7 is am5d$ by add+ at ! end ! foll[+3 7n7 ,requirem5ts ) respect to vacc9e products dur+ public heal? em]g5cies 7#a7 ,em]g5cy meet+ & recomm5dations 7,a7 ,em]g5cy meet+ ,dur+ a public heal? em]g5cy decl>$ by ! ,secret>y "u section #cai ( ! ,public ,heal? ,s]vice ,act & ) respect to a reque/ to au?orize ! use ( an unapprov$ product t is a vacc9e or an unapprov$ use ( an approv$ product t is a vacc9e int5d$ to address ! public heal? ?reat t is ! subject ( su* public heal? em]g5cy1 prior to au?oriz+ use ( su* product1 subject to subp>agraph 7,b71 ! ,secret>y %all conv5e a meet+ at :i* ! ,food & ,drug ,adm9i/ration & ! sponsor ( ! product pres5t data & in=mation on ! product to ! ,vacc9es & ,relat$ ,biological ,products ,advisory ,committee = ! purpose ( review+ & provid+ recomm5dations ) respect to em]g5cy use ( ! product4 7,b7 ,exception ,if ! ,secret>y1 9 consultation ) ! ,commission]1 det]m9es t a meet+ "u subp>agraph 7,a7 ) respect to a product describ$ 9 su* subp>agraph w\ld n be 9 ! public int]e/1 ! ,secret>y may make a det]m9ation n to conv5e su* a meet+4 ,9 ! ev5t t ! ,secret>y det]m9es n to conv5e su* a meet+ pursuant to ?is subp>agraph1 ! ,secret>y %all issue a report to ! ,committee on ,heal?1 ,education1 ,labor1 & ,p5sions ( ! ,s5ate & ! ,committee on ,en]gy & ,comm]ce ( ! ,h\se ( ,repres5tatives t includes ju/ification & relevant public heal? gr\nds = su* det]m9ation4 7#b7 ,requirem5t to seek lic5sure ,an au?orization "u ?is section ) respect to an unapprov$ product t is a vacc9e or an unapprov$ use ( an approv$ product t is a vacc9e %all be condition$ on ! sponsor seek+ lic5sure ( ! product1 or ! use1 z applicable1 "u section #cea ( ! ,public ,heal? ,s]vice ,act1 at ! discretion ( ! ,secret>y1 )9 a "t p]iod det]m9$ by ! ,secret>y4 4 7#b7 ,confid5tial in=mation ,section #efd7;h77#a7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;bbb-#c7;h77#a77 is am5d$-- 7,a7 by ins]t+ 1 includ+ a summ>y review1 aft] data or in=mation2 7,b7 by /rik+ #eje7;i71 #eab7;j71 or #ebj7;g7 & ins]t+ #eje1 #eaj7k71 #eab7;j71 #eac7;f71 #eae1 #ebj7;g71 or #efd ( ?is ,act or section #cea ( ! ,public ,heal? ,s]vice ,act2 & 7,c7 by /rik+ may indirectly reveal ! exi/5ce ( su* application & ins]t+ 1 includ+ a summ>y review1 may indirectly reveal ! exi/5ce ( su* application or conta9 data or in=mation submitt$ 9 an application "u su* sections4 7b7 ,recomm5dations ) respect to vacc9es ,to address a public heal? em]g5cy ,section #cai ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bdg;d7 is am5d$ by add+ at ! end ! foll[+3 7c7 ,recomm5dations ,dur+ a public heal? em]g5cy decl>$ by ! ,secret>y "u subsection 7a71 n lat] ?an #ae days aft] ! au?orization "u section #efd ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act ( an unapprov$ product t is a vacc9e or an unapprov$ use ( an approv$ product t is a vacc9e int5d$ to address ! public heal? ?reat t is ! subject ( su* public heal? em]g5cy1 ! ,advisory ,committee on ,immunization ,practices %all submit to ! ,director ( ! ,c5t]s = ,disease ,control & ,prev5tion1 ! ,secret>y1 ! ,committee on ,heal?1 ,education1 ,labor1 & ,p5sions ( ! ,s5ate1 & ! ,committee on ,en]gy & ,comm]ce ( ! ,h\se ( ,repres5tatives-- 7#a7 recomm5dations reg>d+ vacc9ation1 includ+ prioritization ( populations = :i* ! vacc9e is au?oriz$2 or 7#b7 a report recomm5d+ t ! ,secret>y seek additional data or in=mation 9 ord] = ! committees to develop recomm5dations describ$ 9 p>agraph 7#a74 4