#aae? ,,congress #a/ ,session ,h4 ,r4 #dcgd ,,an ,,act ,to am5d ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act to au?orize additional em]g5cy uses = m$ical products to r$uce dea?s & sev]ity ( injuries caus$ by ag5ts ( w>1 & = o!r purposes4 #a4 ,additional em]g5cy uses = m$ical products to r$uce dea?s & sev]ity ( injuries caus$ by ag5ts ( w> 7a7 ,,fda au?orization = m$ical products = use 9 em]g5cies ,section #efd ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;bbb-#c7 is am5d$-- 7#a7 9 subsection 7b7-- 7,a7 9 p>agraph 7#a71 by am5d+ subp>agraph 7,b7 to read z foll[s3 7,b7 a det]m9ation by ! ,secret>y ( ,def5se t !re is a milit>y em]g5cy1 or a significant pot5tial = a milit>y em]g5cy1 involv+ a height5$ risk to ,unit$ ,/ates milit>y =ces1 includ+ p]sonnel op]at+ "u ! au?ority ( title #aj or title #ej1 ,unit$ ,/ates ,code1 ( attack )-- 7i7 a biological1 *emical1 radiological1 or nucle> ag5t or ag5ts2 or 7ii7 an ag5t or ag5ts t may cause1 or are o!rwise associat$ )1 an imm95tly life-?reat5+ & specific risk to ,unit$ ,/ates milit>y =ces2 2 & 7,b7 by add+ at ! end ! foll[+3 7#f7 ,milit>y em]g5cies ,9 ! case ( a det]m9ation describ$ 9 p>agraph 7#a77;,b71 ! ,secret>y %all det]m9e1 )9 #de cal5d> days ( su* det]m9ation1 :e!r to make a decl>ation "u p>agraph 7#a71 &1 if appropriate1 %all promptly make su* a decl>ation4 2 & 7#b7 9 subsection 7c7-- 7,a7 9 p>agraph 7#c71 by /rik+ 2 & & ins]t+ 22 7,b7 by r$esignat+ p>agraph 7#d7 z p>agraph 7#e72 & 7,c7 by ins]t+ aft] p>agraph 7#c7 ! foll[+3 7#d7 9 ! case ( a det]m9ation describ$ 9 subsection 7b77#a77;,b77ii71 t ! reque/ = em]g5cy use is made by ! ,secret>y ( ,def5se2 & 4 7b7 ,em]g5cy uses = m$ical products 7#a7 ,9 g5]al ,! ,secret>y ( ,def5se may reque/ t ! ,secret>y ( ,heal? & ,human ,s]vices1 act+ ?r\gh ! ,commission] ( ,food & ,drugs1 take actions to exp$ite ! developm5t ( a m$ical product1 review ( inve/igational new drug applications "u section #eje7;i7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cee7;i771 review ( inve/igational device exemptions "u section #ebj7;g7 ( su* ,act 7#ba ,u4,s4,c4 #cfj;j7g771 & review ( applications = approval & cle>ance ( m$ical products "u sections #eje1 #eaj7k71 & #eae ( su* ,act 7#ba ,u4,s4,c4 #cee1 #cfj7k71 #cfj7;e77 & section #cea ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bfb71 includ+ applications = lic5s+ ( vacc9es or blood z biological products "u su* section #cea1 or applications = review ( reg5]ative m$ic9e advanc$ !rapy products "u section #ejf7;g7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cef7;g771 if !re is a milit>y em]g5cy1 or significant pot5tial = a milit>y em]g5cy1 involv+ a specific & imm95tly life-?reat5+ risk to ,unit$ ,/ates milit>y =ces ( attack ) an ag5t or ag5ts1 & ! m$ical product t is ! subject ( su* application1 submission1 or notification w\ld be reasonably likely to diagnose1 prev5t1 treat1 or mitigate su* life-?reat5+ risk4 7#b7 ,actions ,^u a reque/ by ! ,secret>y ( ,def5se "u p>agraph 7#a71 ! ,secret>y ( ,heal? & ,human ,s]vices1 act+ ?r\gh ! ,commission] ( ,food & ,drugs1 %all take action to exp$ite ! developm5t & review ( an applicable application or notification ) respect to a m$ical product describ$ 9 p>agraph 7#a71 :i* may include1 z appropriate-- 7,a7 hold+ meet+s ) ! sponsor & ! review team ?r\gh\t ! developm5t ( ! m$ical product2 7,b7 provid+ timely advice to1 & int]active communication )1 ! sponsor reg>d+ ! developm5t ( ! m$ical product to ensure t ! developm5t program to ga!r ! noncl9ical & cl9ical data necess>y = approval or cle>ance is z effici5t z practicable2 7,c7 involv+ s5ior manag]s & exp]i5c$ review /aff1 z appropriate1 9 a collaborative1 cross-discipl9>y review2 7,d7 assign+ a cross-discipl9>y project lead = ! review team to facilitate an effici5t review ( ! developm5t program & to s]ve z a sci5tific liaison betwe5 ! review team & ! sponsor2 7,e7 tak+ /eps to ensure t ! design ( ! cl9ical trials is z effici5t z practicable1 :5 sci5tifically appropriate1 su* z by m9imiz+ ! numb] ( pati5ts expos$ to a pot5tially less efficaci\s treatm5t2 7,f7 apply+ any applicable ,food & ,drug ,adm9i/ration program int5d$ to exp$ite ! developm5t & review ( a m$ical product2 & 7,g7 9 appropriate circum/ances1 p]mitt+ exp&$ access to ! m$ical product dur+ ! inve/igational phase1 9 accordance ) applicable requirem5ts ( ! ,food & ,drug ,adm9i/ration4 7#c7 ,enhanc$ collaboration & communication ,9 ord] to facilitate enhanc$ collaboration & communication ) respect to ! mo/ curr5t priorities ( ! ,dep>tm5t ( ,def5se-- 7,a7 ! ,food & ,drug ,adm9i/ration %all meet ) ! ,dep>tm5t ( ,def5se & any o!r appropriate developm5t p>tn]s1 su* z ! ,biom$ical ,advanc$ ,rese>* & ,developm5t ,au?ority1 on a semi-annual basis = ! purposes ( conduct+ a full review ( ! relevant products 9 ! ,dep>tm5t ( ,def5se portfolio2 & 7,b7 ! ,director ( ! ,c5t] = ,biologics ,evaluation & ,rese>* %all meet qu>t]ly ) ! ,dep>tm5t ( ,def5se to discuss ! developm5t /atus ( reg5]ative m$ic9e advanc$ !rapy1 blood1 & vacc9e m$ical products & projects t are ! highe/ priorities to ! ,dep>tm5t ( ,def5se 7:i* may include freeze dri$ plasma products & platelet alt]natives71 unless ! ,secret>y ( ,def5se det]m9es t any su* meet+s are n necess>y4 7#d7 ,m$ical product ,9 ?is subsection1 ! t]m m$ical product means a drug 7z def9$ 9 section #bja ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cba771 a device 7z def9$ 9 su* section #bja71 or a biological product 7z def9$ 9 section #cea ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bfb774 7c7 ,repeal ,effective z ( ! enactm5t ( ! ,national ,def5se ,au?orization ,act = ,fiscal ,ye> #bjah1 subsection 7d7 ( section #aajg;a ( title #aj1 ,unit$ ,/ates ,code1 z add$ by section #gaf ( ! ,national ,def5se ,au?orization ,act = ,fiscal ,ye> #bjah1 is repeal$4 ,pass$ ! ,h\se ( ,repres5tatives ,novemb] #ae1 #bjag4;,cl]k4