,i #aag? ,,congress #b;d ,session ,h4 ,r4 #hhbh ,,9 ,,! ,,h\se ,,( ,,repres5tatives ,septemb] #ad1 #bjbb,ms4 ,ku/] introduc$ ! foll[+ bill2 :i* 0 ref]r$ to ! ,committee on ,en]gy & ,comm]ce ,a ,,bill ,to address pot5tial conflicts ( int]e/ among entities s]v+ z ,food & ,drug ,adm9i/ration contractors1 & = o!r purposes4 #a4 ,%ort title ,?is ,act may be cit$ z ! ,,fda ,e?ics ,act ( #bjbb4 #b4 ,requirem5ts reg>d+ ongo+ report+ ( contractor conflicts ( int]e/ 7a7 ,9 g5]al ,! ,secret>y ( ,heal? & ,human ,s]vices %all require entities t contract ) ! ,food & ,drug ,adm9i/ration-- 7#a7 to disclose1 on an ongo+ basis dur+ ! t]m ( ! contract1 any in=mation relat$ to pot5tial & actual conflicts ( int]e/1 includ+ conflicts ( int]e/ conc]n+ ! contractor's p]sonnel1 consultants1 & subcontractors2 & 7#b7 dur+ ! t]m ( ! contract1 to refra9 f ent]+ into consult+ or o!r contractual arrangem5ts ) any p]son to p]=m "w t may reasonably create a pot5tial or actual conflict ( int]e/1 )\t receiv+ ! writt5 approval ( ! contract+ (fic] be=e ! execution ( ! contractual arrangem5t4 7b7 ,regulations ,n lat] ?an #ah mon?s aft] ! date ( enactm5t ( ?is ,act1 ! ,secret>y1 9 consultation ) ! ,f$]al ,acquisition ,regulatory ,c\ncil1 %all issue regulations to c>ry out subsection 7a74 #c4 ,requirem5ts reg>d+ waiv]s relat+ to organizational conflicts ( int]e/ 7a7 ,9 g5]al ,! ,secret>y ( ,heal? & ,human ,s]vices 7ref]r$ to 9 ?is section z ! ,secret>y7 %all1 n lat] ?an #ad days aft] aw>d+ a contract relat+ to ! ,food & ,drug ,adm9i/ration1 publi%1 on ! website ( ! ,food & ,drug ,adm9i/ration1 a notification ( any waiv] ( any requirem5ts reg>d+ a pot5tial or actual organizational conflict ( int]e/ grant$ to ! contractor4 ,su* notification %all be made publicly available 9 an easily accessible =mat1 & %all include ! "n ( ! contract1 ! contractor receiv+ ! waiv]1 ! o!r contracts or cli5ts t creat$ ! pot5tial or actual organizational conflict ( int]e/1 & ! ef=ts t ! contractor plans to take to mitigate ! pot5tial or actual organizational conflict ( int]e/4 7b7 ,regulations ,n lat] ?an #ah mon?s aft] ! date ( enactm5t ( ?is ,act1 ! ,secret>y1 9 consultation ) ! ,f$]al ,acquisition ,regulatory ,c\ncil1 %all issue regulations to c>ry out subsection 7a74 #d4 ,re/rictions on consult+ firms s]v+ z ,,fda contractors 7a7 ,prohibition aga9/ c]ta9 contracts 7#a7 ,9 g5]al ,subject to p>agraph 7#b71 ! ,secret>y ( ,heal? & ,human ,s]vices 7ref]r$ to 9 ?is section z ! ,secret>y7 %all n aw>d a contract relat+ to ! duties ( ! ,food & ,drug ,adm9i/ration to any p]son provid+ consult+ s]vices 7ref]r$ to 9 ?is section z a consult+ firm7 unless su* contract provides t1 dur+ ! re/rict$ p]iod describ$ 9 p>agraph 7#c71 subject to p>agraph 7#b71 no individual employee or subcontractor ( su* consult+ firm may provide s]vices to bo?-- 7,a7 ! ,food & ,drug & ,adm9i/ration "u ! consult+ firm's contract2 & 7,b7 7i7 a p]son engag$ 9 ! developm5t or manufactur+ ( a device1 drug1 or biological product2 or 7ii7 any o!r private entity engag$ 9 activities regulat$ by ! ,food & ,drug ,adm9i/ration4 7#b7 ,exception 7,a7 ,9 g5]al ,! ,secret>y may issue an exception to ! requirem5t "u p>agraph 7#a7 ) respect to an employee or subcontractor ( a consult+ firm only if ! ,secret>y or designee det]m9es 9 writ+ t !re is a compell+ reason to aw>d a contract ) su* consult+ firm ) su* exception4 ,! ,secret>y %all n delegate ! au?ority to issue exceptions "u ?is subp>agraph bel[ ! level ( head ( a contract+ activity4 7,b7 ,report+ ,n lat] ?an #ad days aft] issu+ an exception "u subp>agraph 7,a71 ! ,secret>y %all publi%1 on ! website ( ! ,food & ,drug ,adm9i/ration1 a notification ( ! exception4 ,su* notification %all be made publicly available 9 an easily accessible =mat1 & %all include-- 7i7 ! "n ( ! contract2 7ii7 ! consult+ firm receiv+ ! exception1 & ! employee or subcontractor to :om ! exception applies2 7iii7 ! o!r contracts or cli5ts t w\ld1 9 ! abs5ce ( ! exception1 cause ! consult+ firm to be 9 violation ( p>agraph 7#a72 & 7iv7 ! ef=ts t ! consult+ firm plans to take to mitigate any pot5tial or actual conflict ( int]e/ aris+ f ! o!r "w ( its employees or subcontractors4 7#c7 ,re/rict$ p]iod 7,a7 ,9 g5]al ,= purposes ( p>agraph 7#a71 ! re/rict$ p]iod is ! p]iod t-- 7i7 beg9s :5 ! applicable employee or subcontractor ( ! consult+ firm fir/ provides s]vices "u ! consult+ firm's contract2 & 7ii7 ends n less ?an ! applicable p]iod specifi$ 9 subp>agraph 7,b7 aft] ! la/ date on :i* su* employee or subcontractor provides s]vices "u ! consult+ firm's contract4 7,b7 ,applicable p]iod specifi$ ,= purposes ( subp>agraph 7,a77ii71 ! applicable p]iod specifi$ 9 ?is subp>agraph is-- 7i7 #cj days2 or 7ii7 su* long] p]iod ( "t z ! ,secret>y may specify aft] consultation ) ! ,f$]al ,acquisition ,regulatory ,c\ncil1 :i* %all apply ) respect to all exceptions issu$ "u p>agraph 7#b74 7b7 ,regulations ,n lat] ?an #ah mon?s aft] ! date ( enactm5t ( ?is ,act1 ! ,secret>y1 9 consultation ) ! ,f$]al ,acquisition ,regulatory ,c\ncil1 %all issue regulations to c>ry out subsection 7a74 7c7 ,def9ition ,9 ?is section1 ! t]m consult+ s]vices-- 7#a7 means provid+ advice or recomm5dations to improve organizational effectiv5ess2 & 7#b7 does n include s]vices provid$ pursuant to a contract relat$ to regulatory sci5ce rese>*1 public heal? surveillance1 or in=mation te*nology1 or s]vices provid$ by a small bus9ess conc]n4