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Q`c. 78 J`kmfy,K`. =6 Jfrob ?, 456=

Ufrt HH

Mnpfrtjnkt `a Bnfctb fkm Bujfk _nrvhons

A``m fkm Mrug Fmjhkhstrfth`k

46 OAT Ufrt 656A``m Cfdnchkg9 Tnvhsh`k `a tbn Kutrhth`k fkm _uppcnjnkt Afots Cfdncs;4565 68951 And 42, 456= Ilt 4?4556 U@ 55555 Arj 55556 Ajt =767 _ajt =767 N9SATSAJS5?JTU4._GJ 5?JTU4

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66225 Anmnrfc Tnghstnr / Q`c. 78, K`. =6/ J`kmfy, Jfrob ?, 456= / Ur`p`snm Tucns

MNUFT]JNK] @A BNFC]B FKMB^JFK _NTQHON_

A``m fkm Mrug Fmjhkhstrfth`k

46 OAT Ufrt 656

\M`olnt K`. AMF4564K6465Z

THK 5865FA44

A``m Cfdnchkg9 Tnvhsh`k `a tbnKutrhth`k fkm _uppcnjnkt Afots Cfdncs

FGNKOX9 A``m fkm Mrug Fmjhkhstrfth`k,BB_.FO]H@K9 Ur`p`snm rucn.

_^JJFTX9 ]bn A``m fkm MrugFmjhkhstrfth`k (AMF, tbn Fgnkoy, `rwn) hs pr`p`shkg t` fjnkm hts cfdnchkgrngucfth`ks a`r o`kvnkth`kfc a``ms fkmmhntfry suppcnjnkts t` pr`vhmn upmftnmkutrhth`k hka`rjfth`k `k tbn cfdnc t`fsshst o`ksujnrs hk jfhktfhkhkg bnfctbymhntfry prfothons. ]bn upmftnm

hka`rjfth`k hs o`kshstnkt whtb ourrnktmftf `k tbn fss`ohfth`ks dntwnnkkutrhnkts fkm obr`kho mhsnfsns `rbnfctb-rncftnm o`kmhth`ks, rnacnotsourrnkt pudcho bnfctb o`kmhth`ks hk tbn^khtnm _tftns, fkm o`rrnsp`kms t` knwhka`rjfth`k `k o`ksujnr dnbfvh`r fkmo`ksujpth`k pfttnrks. Wn frn pr`p`shkgt` upmftn tbn chst `a kutrhnkts tbft frnrnquhrnm `r pnrjhttnm t` dn mnocfrnm dyFprhc 4, 456= (snn tbn Ufpnrw`rlTnmuoth`k Fot `a 688> snoth`k `a tbhsm`oujnkt). _nn snoth`k HHH `a tbhsm`oujnkt a`r tbn pr`p`snm naanothvnmftn `a f ahkfc rucn dfsnm `k tbhspr`p`snm rucn.FMMTN__N_9 X`u jfy sudjht o`jjnkts,hmnkthahnm dy M`olnt K`. AMF4564K6465, fkm/`r Tngucft`ry Hka`rjfth`kKujdnr (THK) 5865FA44, dy fky `a tbna`cc`whkg jntb`ms, nxonpt tbfto`jjnkts `k hka`rjfth`k o`ccnoth`khssuns ukmnr tbn Ufpnrw`rl Tnmuoth`kFot `a 688> just dn sudjhttnm t` tbn@aahon `a Hka`rjfth`k fkm Tngucft`ryFaafhrs, @aahon `a Jfkfgnjnkt fkmDumgnt (@JD) (snn tbn Ufpnrw`rl

Tnmuoth`k Fot `a 688> snoth`k `a tbhsm`oujnkt).

Ncnotr`kho _udjhssh`ks

_udjht ncnotr`kho o`jjnkts hk tbna`cc`whkg wfy9

Anmnrfc nTucnjflhkg U`rtfc9 bttp9//www.rngucfth`ks.g`v. A`cc`w tbnhkstruoth`ks a`r sudjhtthkg o`jjnkts.

Wrhttnk _udjhssh`ks

_udjht wrhttnk sudjhssh`ks hk tbna`cc`whkg wfys9

Jfhc/Bfkm mnchvnry/O`urhnr (a`rpfpnr sudjhssh`ks)9 Mhvhsh`k `a M`olntsJfkfgnjnkt (BAF?5>), A``m fkm MrugFmjhkhstrfth`k, >?15 Ahsbnrs Cfkn, Tj.6516, T`olvhccn, JM 452>4.

Hkstruoth`ks9 Fcc sudjhssh`ks rnonhvnmjust hkocumn tbn Fgnkoy kfjn fkmM`olnt K`. AMF4564K6465 fkm THK5865FA44 a`r tbhs rucnjflhkg. Fcco`jjnkts rnonhvnm jfy dn p`stnmwhtb`ut obfkgn t` bttp9//www.rngucfth`ks.g`v, hkocumhkg fky

pnrs`kfc hka`rjfth`k pr`vhmnm. A`rfmmhth`kfc hka`rjfth`k `k sudjhtthkgo`jjnkts, snn tbn O`jjnkts bnfmhkg`a tbn _^UUCNJNK]FTX HKA@TJF]H@Ksnoth`k `a tbhs m`oujnkt.

M`olnt9 A`r foonss t` tbn m`olnt t`rnfm dfolgr`ukm m`oujnkts `ro`jjnkts rnonhvnm, g` t` bttp9//www.rngucfth`ks.g`v fkm hksnrt tbnm`olnt kujdnr, a`ukm hk drfolnts hk tbnbnfmhkg `a tbhs m`oujnkt, hkt` tbn_nfrob d`x fkm a`cc`w tbn pr`jptsfkm/`r g` t` tbn Mhvhsh`k `a M`olntsJfkfgnjnkt, >1?5 Ahsbnrs Cfkn, rj.6516, T`olvhccn, JM 452>4.

A@T A^T]BNT HKA@TJF]H@K O@K]FO]9Dcflncny Ahtzpftrhol, Onktnr a`r A``m_fanty fkm Fppchnm Kutrhth`k (BA_2?5), A``m fkm Mrug Fmjhkhstrfth`k,>655 Ufhkt Drfkob Ulwy., O`ccngn Ufrl,JM 457=5, 4=5=54>=48, njfhc9Kutrhth`kUr`grfj_tfaaEamf.bbs.g`v.

Whtb rngfrm t` tbn hka`rjfth`ko`ccnoth`k9 M`jhkh Dnfk, @aahon `aHka`rjfth`k Jfkfgnjnkt, A``m fkmMrug Fmjhkhstrfth`k, 6?>5 Uhoofrm Mr.,UH>5=55], T`olvhccn, JM 452>5,M`jhkh.dnfkEamf.bbs.g`v._^UUCNJNK]FTX HKA@TJF]H@K9

]fdcn `a O`ktnkts

Nxnouthvn _ujjfry

H. Dfolgr`ukmF. Cngfc Futb`rhtyD. Knnm ]` ^pmftn tbn Kutrhth`k Afots fkm

_uppcnjnkt Afots Cfdncs6. Tftns a Obr`kho Mhsnfsn4. Mhntfry Tno`jjnkmfth`ks, O`ksnksus

Tnp`rts, fkm Kfth`kfc _urvny Mftf?. O`ksujnr ^sn fkm ^kmnrstfkmhkg `a tbn

Kutrhth`k Afots Cfdnc=. @tbnr Tncnvfkt O`kshmnrfth`ks>. Ohthznk Unthth`ks1. Fmvfkon K`thons `a Ur`p`snm

Tucnjflhkg (FKUTJs)

7. Hjpfot `k @tbnr Tngucfth`ksO. Afot`rs a`r Jfkmft`ry r Q`cuktfry

Mnocfrfth`k a K`k-_tftut`ry Kutrhnkts6. Afot`rs O`kshmnrnm4. Fppr`fob a`r Jfkmft`ry Mnocfrfth`k?. Fppr`fob a`r Q`cuktfry Mnocfrfth`k

HH. ]bn Ur`p`snm TucnF. Ofc`rhns6. Ofc`rhns Ar`j Aft4. Ofc`rhns Ar`j _fturftnm Aft

?. ]w` ]b`usfkm Ofc`rhns fs tbn TnanrnkonOfc`rho Hktfln Cnvnc

=. Unronkt MQ Mnocfrfth`k a`r Ofc`rhnsD. Aft6. ]`tfc Aft4. _fturftnm Aft?. ]rfks Aft=. U`cyuksfturftnm Aft>. J`k`uksfturftnm AftO. Ob`cnstnr`c6. Jfkmft`ry Mnocfrfth`k4. MTQM. Ofrd`bymrftn6. ]`tfc Ofrd`bymrftn4. _ugfrs?. Fmmnm _ugfrs=. _ugfr Fco`b`cs>. Mhntfry Ahdnr1. @tbnr Ofrd`bymrftnN. Ur`tnhk6. Jfkmft`ry fkm Q`cuktfry Mnocfrfth`k4. Fkfcythofc Jntb`ms?. MTQA. _`mhuj6. Jfkmft`ry Mnocfrfth`k4. MTQG. Acu`rhmn6. Q`cuktfry Mnocfrfth`k4. MTQB. Nssnkthfc Qhtfjhks fkm Jhknrfcs `a

Uudcho Bnfctb _hgkhahofkon6. Nssnkthfc Qhtfjhks fkm Jhknrfcs ]bft

Frn Jfkmft`ry

4. Nssnkthfc Qhtfjhks fkm Jhknrfcs ]bftFrn Q`cuktfry?. @tbnr Nssnkthfc Qhtfjhks fkm Jhknrfcs=. _ujjfryH. Tnanrnkon Mfhcy Hktflns a`r Qhtfjhks fkm

Jhknrfcs6. Knnm ]` ^pmftn TMHs4. Fppr`fob ]` _ntthkg TMHs9 NFT Qnrsus

TMF?. Fppr`fob ]` _ntthkg TMHs9 Fmnquftn

Hktfln=. Fppr`fob ]` _ntthkg TMHs9 ]`cnrfdcn

^ppnr Hktfln Cnvnc>. Fppr`fob ]` _ntthkg TMHs9 U`pucfth`k-

Wnhgbtnm Qnrsus U`pucfth`k-O`vnrfgn1. Mnocfrfth`k `a tbn Fds`cutn Fj`ukts `a

Qhtfjhks fkm Jhknrfcs

7. Hssuns O`konrkhkg _pnohaho Qhtfjhks fkmJhknrfcsI. ^khts a Jnfsurn, Fkfcythofc Jntb`ms,

fkm ]nrjs a`r Qhtfjhks fkm Jhknrfcs6. _`mhuj, U`tfsshuj, O`ppnr, fkm

Obc`rhmn4. A`cftn fkm A`cho Fohm?. Qhtfjhks F, M, fkm NL. Cfdnchkg `a A``ms a`r Hkafkts, X`ukg

Obhcmrnk, fkm Urngkfkt `r CfotfthkgW`jnk

6. Fgn Tfkgn a`r Hkafkts fkm X`ukgObhcmrnk

4. Jfkmft`ry Mnocfrfth`k `a Ofc`rhns fkm_tftut`rhcy Tnquhrnm Kutrhnkts

QnrMftn Jfr36>;4565 68951 And 42, 456= Ilt 4?4556 U@ 55555 Arj 55554 Ajt =756 _ajt =754 N9SATSAJS5?JTU4._GJ 5?JTU4

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66226Anmnrfc Tnghstnr / Q`c. 78, K`. =6/ J`kmfy, Jfrob ?, 456= / Ur`p`snm Tucns

?. Mnocfrfth`k a K`k-_tftut ry Kutrhnkts@tbnr ]bfk Nssnkthfc Qhtfjhks fkmJhknrfcs

=. Mnocfrfth`k `a Nssnkthfc Qhtfjhks fkmJhknrfcs

>. MTQs fkm TMHs a`r Hkafkts 7 ]br`ugb 64J`ktbs `a Fgn

1. MTQs fkm TMHs a`r Obhcmrnk 6 ]br`ugb? Xnfrs `a Fgn

7. MTQs fkm TMHs a`r Urngkfkt fkm

Cfotfthkg W`jnkC. Mhntfry _uppcnjnkts6. Jfkmft`ry Mhntfry Hkgrnmhnkts4. A`cftn fkm A`cho Fohm?. ^khts `a Jnfsurn=. @rmnr `a Kutrhnkts Mnocfrnm `k tbn Cfdnc>. _udp`pucfth`ks1. A``tk`tnJ. A`rjft6. Hkornfshkg tbn Ur`jhknkon `a Ofc`rhns

fkm _nrvhkg _hzn4. Obfkghkg tbn @rmnr `a tbn _nrvhkg

_hzn fkm _nrvhkgs Unr O`ktfhknrMnocfrfth`ks fkm Hkornfshkg tbnUr`jhknkon `a _nrvhkgs Unr O`ktfhknr

?. Thgbt-Iusthayhkg tbn VufkthtfthvnFj`ukts Mnocfrnm hk tbn _nrvhkg _hzn

_tftnjnkt=. Obfkghkg tbn Fj`ukt Unr _nrvhkg_tftnjnkt

>. Mnocfrfth`k a Ofc`rhns Ar`j Aft1. Urnsnktfth`k `a Unronkt MQs7. Ucfonjnkt `a Fmmnm _ugfrs2. Mnocfrfth`k a Fds`cutn Fj`ukts a

Qhtfjhks fkm Jhknrfcs8. _hkgcn fkm Mufc O`cujk Cfdnchkg65. ]bn A``tk`tn66. ^sn `a Bhgbchgbthkg Whtb f ]ypn

Hktnrjnmhftn Dntwnnk D`cm `r Nxtrf D`cmfkm Tngucfr ]ypn

64. Fmmhth`k `a B`rhz`ktfc Chkn Dnknftbtbn Kutrhth`k Afots Bnfmhkg

6?. Tnpcfohkg ]`tfc Ofrd`bymrftn Whtb]`tfc Ofrds

6=. Fctnrkfthvn Qhsufc A`rjfts/A`kts

K. O`jpchfkon6. Cnvnc a Qfrhfkon Fcc`wnm a`r tbn Cfdnc

Mnocfrfth`k `a _pnohaho Kutrhnkts4. Jntb`ms ^snm ]` Mntnrjhkn

O`jpchfkon?. Tno`rms Tnquhrnjnkts=. Hkocush`k `a U`tfsshuj fs f Jhknrfc>. Tnquhrnjnkts a`r @tbnr Ofrd`bymrftn,

_`cudcn fkm Hks`cudcn Ahdnr, Fmmnm_ugfrs, fkm _ugfr Fco`b`cs

@. ]nobkhofc Fjnkmjnkts6. Obfkghkg tbn Kfjn `a tbn Ur`grfj

@aahon4. Obfkghkg tbn Uudchofth`k Mftn `a Tnp`rt

Hko`rp`rftnm dy Tnanrnkon?. Ucfhk Cfkgufgn Nmhts

HHH. Ur`p`snm Naanothvn fkm O`jpchfkon Mftns

HQ. Fkfcyshs `a HjpfotsQ. Ufpnrw`rl Tnmuoth`k Fot `a 688>QH. Fkfcyshs `a Nkvhr`kjnktfc HjpfotQHH. AnmnrfchsjQHHH. O`jjnktsHR. Tnanrnkons

Nxnouthvn _ujjfry

Uurp`sn `a tbn Tngucft`ry Foth`k

AMF hs pr`p`shkg t` fjnkm tbnrngucfth`ks a`r tbn kutrhth`k cfdnchkg `ao`kvnkth`kfc a``ms fkm mhntfrysuppcnjnkts t` fsshst o`ksujnrs hkjfhktfhkhkg bnfctby mhntfry prfothons.

A`cc`whkg tbn pfssfgn `a tbn Kutrhth`kCfdnchkg fkm Nmuofth`k Fot (KCNF) `a6885 (tbn 6885 fjnkmjnkts) (Uud. C.656>?>), wbhob fmmnm snoth`k =5?(q) `atbn Anmnrfc A``m, Mrug, fkm O`sjnthoFot (tbn AM&O Fot) (46 ^._.O. ?=?(q)),wn hssunm vfrh`us rngucfth`ks rncftnm t`kutrhth`k hka`rjfth`k `k a``m cfdncs,hkocumhkg tbn mnocfrfth`k `a kutrhnkts,

tbn a`rjft a`r kutrhth`k cfdnchkg,rnanrnkon vfcuns a`r usn hk mnocfrhkg tbnkutrhnkt o`ktnkt, fkm fcc`wfkons a`ronrtfhk spnohahnm pr`muots t` dn nxnjptar`j kutrhth`k cfdnchkg (656.8 (46 OAT656.8)). Hk fmmhth`k, a`cc`whkg tbnpfssfgn `a tbn Mhntfry _uppcnjnktBnfctb fkm Nmuofth`k Fot (M_BNF) `a688= (Uud. C. 65?=67 fkm 46 ^._.O.?46(aa)), wn fjnkmnm `ur a``m cfdnchkgrngucfth`ks t` nstfdchsb rnquhrnjnkts a`rkutrhth`k cfdnchkg `a mhntfrysuppcnjnkts (656.8(i)(1) fkm 656.?1)._noth`k =5?(q) `a tbn AM&O Fot spnohahnsonrtfhk kutrhnkts t` dn mnocfrnm hk

kutrhth`k cfdnchkg, fkm futb`rhzns tbn_norntfry `a Bnfctb fkm Bujfk _nrvhonst` rnquhrn `tbnr kutrhnkts t` dn mnocfrnmha tbn _norntfry mntnrjhkns tbft fkutrhnkt whcc pr`vhmn hka`rjfth`krngfrmhkg tbn kutrhth`kfc vfcun `a suoba``m tbft whcc fsshst o`ksujnrs hkjfhktfhkhkg bnfctby mhntfry prfothons.]bn _norntfry fcs` bfs mhsornth`k ukmnrsnoth`k =5?(q) `a tbn AM&O Fot t`rnj`vn, dy rngucfth`k fkm ukmnr onrtfhkohroujstfkons, kutrhnkt hka`rjfth`k tbfths `tbnrwhsn nxpchohtcy rnquhrnm hk a``mcfdnchkg ukmnr tbhs snoth`k.

Wn frn pr`p`shkg t` rnvhsn `urrngucfth`ks t` pr`vhmn upmftnm kutrhth`k

hka`rjfth`k `k tbn cfdnc fkm hjpr`vnb`w tbn kutrhth`k hka`rjfth`k hsprnsnktnm t` o`ksujnrs, hk chgbt `aourrnkt sohnkthaho nvhmnkon, mhntfryrno`jjnkmfth`ks `a j`st rnonkto`ksnksus rnp`rts, fkm pudchoo`jjnkts rnonhvnm hk rnsp`ksn t`fmvfkon k`thons `a pr`p`snmrucnjflhkg. AMF hkvhtns o`jjnkt `k htsusn `a tbn j`st rnonkt o`ksnksus rnp`rtsfkm wbntbnr tbn hka`rjfth`k fkm mftf`k wbhob AMF rnchns ar`j suob rnp`rtsa`r pr`p`snm obfkgns hs o`kshstnkt whtbourrnkt sohnkthaho hka`rjfth`k.

_ujjfry `a tbn Jfi`r Ur`vhsh`ks `a tbn

Tngucft`ry Foth`k hk Vunsth`kWn mhsouss tbn knnm t` upmftn tbn

Kutrhth`k Afots fkm _uppcnjnkt Afotscfdncs hk snoth`k H.D., fkm `ur sohnkthahoo`kshmnrfth`ks a`r jfkmft`ry fkmv`cuktfry mnocfrfth`k `a kutrhnkts frnprnsnktnm hk snoth`k H.O. Hk snoth`ks HH.F.tbr`ugb HH.L., wn mhsouss pr`vhsh`ksrncftnm t` tbn mnocfrfth`k, rnanrnkonvfcuns, fkfcythofc jntb`ms, fkmmnahkhth`ks `a kutrhnkts tbft frn rnquhrnm`r pnrjhttnm t` dn mnocfrnm `k tbnKutrhth`k Afots cfdnc `a o`kvnkth`kfc

a``ms, wbnrnfs o`rrnsp`kmhkg obfkgnst` tbn _uppcnjnkt Afots cfdnc `a mhntfrysuppcnjnkts frn prnsnktnm hk snoth`kHH.C. Wn prnsnkt `ur o`kshmnrfth`ksrncftnm t` tbn a`rjft `a tbn Kutrhth`kAfots fkm _uppcnjnkt Afots cfdncs hksnoth`k HH.J., fkm mhsouss hssuns rncftnmt` o`jpchfkon whtb tbn pr`p`snmrnquhrnjnkts hk snoth`k HH.K. _`jn `a

tbn lny pr`p`snm foth`ks fkmo`kshmnrfth`ks `a tbn pr`p`snm rucn frnbhgbchgbtnm hk tbhs m`oujnkt.

Fj`kg `tbnr fjnkmjnkts rncftnm t`mnocfrfth`k `a kutrhnkts, wn frnpr`p`shkg t` rnj`vn tbn mnocfrfth`k `aOfc`rhns ar`j aft dnofusn ourrnktsohnkon supp`rts f vhnw tbft tbn typn `aaft hs j`rn rncnvfkt tbfk `vnrfcc t`tfc afthktfln hk hkornfsnm rhsl `a obr`khomhsnfsns. Hk fmmhth`k, rnj`vfc `a tbnofc`rhns ar`j aft mhsoc`surn bfm k`naanot `k o`ksujnrs iumgjnkts `apr`muot bnfctbaucknss, foourfoy hkhmnkthayhkg kutrhnkt o`ktnkts `a

pr`muots, `r pnronpth`ks hk AMFso`ksujnr rnsnfrob.O`kshmnrhkg ourrnkt sohnkon fkm

rno`jjnkmfth`ks rncftnm t` fmmnmsugfrs, wn frn fcs` pr`p`shkg t` rnquhrntbn mnocfrfth`k `a fmmnm sugfrs, tbftwhcc pr`vhmn o`ksujnrs whtbhka`rjfth`k tbny knnm t` hjpcnjnkt tbnmhntfry rno`jjnkmfth`ks `a tbn MhntfryGuhmnchkns a`r Fjnrhofks, 4565 (4565MGF).

Wn frn fcs` pr`p`shkg t` upmftn tbnchst `a vhtfjhks fkm jhknrfcs `a pudchobnfctb shgkhahofkon. Wn ourrnktcyrnquhrn tbn jfkmft`ry mnocfrfth`k `apnronkt Mfhcy Qfcuns (MQs) `a vhtfjhks

F fkm O, ofcohuj fkm hr`k. Wn fkfcyznmtbn kutrhnkt hkfmnqufoy a`r vhtfjhksfkm jhknrfcs dfsnm `k dh`jfrlnr mftffkm t`tfc mhntfry hktfln (o`kvnkth`kfca``ms fkm mhntfry suppcnjnkts) ushkgKfth`kfc Bnfctb fkm Kutrhth`kNxfjhkfth`k _urvny (KBFKN_) mftffkm `tbnr afot`rs a`r jfkmft`ry fkmv`cuktfry mnocfrfth`k mhsoussnm hksnoth`k H.O. t` mntnrjhkn wbhob nssnkthfcvhtfjhks fkm jhknrfcs sb`ucm dnhkocumnm fs kutrhnkts `a pudcho bnfctbshgkhahofkon. Dfsnm `k tbhs fkfcyshs, wnfrn k`t pr`p`shkg fky obfkgns t` tbnourrnkt rnquhrnjnkt a`r jfkmft`ry

mnocfrfth`k `a ofcohuj fkm hr`k. Hkfmmhth`k, wn frn pr`p`shkg t` rnquhrntbn mnocfrfth`k `a vhtfjhk M fkmp`tfsshuj, fkm t` pnrjht, rftbnr tbfkrnquhrn, tbn mnocfrfth`k `a vhtfjhks Ffkm O.

Whtb rnspnot t` rnanrnkon vfcuns usnmt` mnocfrn pnronkt MQs `a kutrhnkts,shkon 688?, knw rnp`rts ar`j tbnHksthtutn `a Jnmhohkn (H@J) fkm `tbnro`ksnksus fkm p`choy rnp`rts (a`rnxfjpcn, tbn 4565 MGF fkm tbn Tnp`rt`a tbn Mhntfry Guhmnchkns Fmvhs`ryO`jjhttnn `k tbn Mhntfry Guhmnchkns a`r

QnrMftn Jfr36>;4565 68951 And 42, 456= Ilt 4?4556 U@ 55555 Arj 5555? Ajt =756 _ajt =754 N9SATSAJS5?JTU4._GJ 5?JTU4

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6622?Anmnrfc Tnghstnr / Q`c. 78, K`. =6/ J`kmfy, Jfrob ?, 456= / Ur`p`snm Tucns

jfy dn lnpt fs `rhghkfc rno`rms, fs truno`phns, `r ncnotr`khofccy, fkmjfkuafoturnrs just pr`vhmn tb`snrno`rms t` us a`r hkspnoth`k fkm o`pyhkgup`k rnqunst murhkg fk hkspnoth`k.

Wn fkthohpftn tbft o`ksujnrnmuofth`k naa`rts w`ucm dn knnmnm t`bncp whtb o`ksujnr ukmnrstfkmhkg fkmusn `a hka`rjfth`k prnsnktnm ukmnr tbn

obfkgns t` tbn Kutrhth`k Afots fkm_uppcnjnkt Afots cfdncs pr`p`snm hktbhs rucn. Wn pcfk t` usn tbn rnsucts `a`ur o`ksujnr rnsnfrob t` bncp hka`rj`ur auturn foth`ks `k tbhs hssun.

Ahkfccy, wn frn pr`p`shkg fk naanothvnmftn `a 15 mfys fatnr tbn mftn `a tbn ahkfcrucns pudchofth`k hk tbn AnmnrfcTnghstnr whtb f o`jpchfkon mftn 4 ynfrsfatnr tbn naanothvn mftn. Wn hkvhtno`jjnkt `k tbn pr`p`snm o`jpchfkonmftn. Hk fmmhth`k t` tbn pr`p`snmo`jpchfkon mftn, wn hkvhtn o`jjnkt `kvfrh`us `tbnr hssuns, fs sujjfrhznm hk

snoth`k RH.

O`sts fkm Dnknahts

Wn bfvn mnvnc`pnm `kno`jprnbnkshvn prnchjhkfry rngucft`ry

hjpfot fkfcyshs tbft prnsnkts tbndnknahts fkm o`sts `a tbhs pr`p`snm rucnfs wncc fs tbn pr`p`snm rucns nkthtcnmA``m Cfdnchkg9 _nrvhkg _hzns `a A``ms]bft Ofk Tnfs`kfdcy Dn O`ksujnm ft@kn Nfthkg @oofsh`k< Mufc O`cujkCfdnchkg< ^pmfthkg, J`mhayhkg, fkmNstfdchsbhkg Onrtfhk Tnanrnkon Fj`uktsOust`jfrhcy O`ksujnm< _nrvhkg _hzn a`r

Drnftb Jhkts< fkm ]nobkhofcFjnkmjnkts tflnk t`gntbnr. ]bnoujucfthvn hjpfot `a tbnsn tw`kutrhth`k cfdnchkg pr`p`sfcs, tflnk fs fwb`cn, hs sb`wk hk tbn a`cc`whkg tfdcn.

_^JJFTX @A O@_]_ FKM DNKNAH]_\Hk dhcch`ks `a 4566 $Z

Dnknahts O`sts Knt dnknahts

Urnsnkt Qfcun (UQ)9?% ............................................................................................................................. $?6.= $4.? $48.67% ............................................................................................................................. 46.6 4.? 62.2

Fkkufchznm (?% UQ Fj`ukt)?% ............................................................................................................................. 4.5 5.4 6.2

Fkkufchznm (7% UQ Fj`ukt)7% ............................................................................................................................. 6.8 5.4 6.7

K`tns9 O`jpchfkon pnrh`m hs 4= j`ktbs. O`sts hkocumn rncfdnchkg fkm rna`rjucfth`k o`sts, wbhob frn `kn-thjn o`sts, fs wncc fs rno`rmlnnphkgo`sts, wbhob rnour. Urnsnkt vfcuns `a rncfdnchkg fkm rna`rjucfth`k o`sts frn nquhvfcnkt ft ? `r 7 pnronkt dnofusn wn o`ksnrvfthvncy fssujn tbfttbnsn `kn-thjn o`sts frn hkourrnm up`k pudchofth`k `a tbn rucn hkstnfm `a ft tbn nkm `a tbn o`jpchfkon pnrh`m. Tno`rmlnnphkg o`sts, dnofusn `atbnhr rnourrhkg kfturn, mhaanr dy mhso`ukt rftn< b`wnvnr, suob o`sts o`jprhsn f vnry sjfcc pnronktfgn `a t`tfc o`sts.

H. Dfolgr`ukm

]bn 6885 fjnkmjnkts fmmnm snoth`k=5?(q) t` tbn AM&O Fot, wbhob spnohahns,hk pfrt fkm whtb onrtfhk nxonpth`ks, tbfta``m hs mnnjnm jhsdrfkmnm ukcnss htscfdnc `r cfdnchkg dnfrs kutrhth`khka`rjfth`k a`r onrtfhk kutrhnkts. ]`

hjpcnjnkt tbn 6885 fjnkmjnkts, `kIfkufry 1, 688?, AMF hssunm snvnrfcrucns, hkocumhkg A``m Cfdnchkg9Jfkmft`ry _tftus `a Kutrhth`k Cfdnchkgfkm Kutrhnkt O`ktnkt Tnvhsh`k, A`rjfta`r Kutrhth`k Cfdnc (tbn 688? kutrhnkto`ktnkt ahkfc rucn)< A``m Cfdnchkg2 AT 4578< >2 AT 4451< >2 AT 4448,rnspnothvncy). AMF pudchsbnmrngucfth`ks rncftnm t`9 (6) Mnocfrfth`k `a

kutrhnkts `k a``m cfdnchkg, hkocumhkgkutrhnkts tbft frn rnquhrnm `r pnrjhttnmt` dn mnocfrnm fkm tbn a`rjft a`r suobmnocfrfth`k< (4) cfdnc rnanrnkon vfcunsa`r usn hk mnocfrhkg tbn kutrhnkt o`ktnkt`a f a``m `k hts cfdnc `r cfdnchkg< (?) tw`typns `a rnanrnkon vfcuns, TnanrnkonMfhcy Hktflns (TMHs) a`r vhtfjhks fkmjhknrfcs fkm Mfhcy Tnanrnkon Qfcuns(MTQs) a`r onrtfhk kutrhnkts, wbhob frnusnm t` mnocfrn kutrhnkt o`ktnkts fspnronkt MQs `k tbn Kutrhth`k Afotscfdnc< (=) nxnjpth`ks a`r onrtfhkspnohahnm pr`muots< fkm (>) f shjpchahnm

a`rj `a kutrhth`k cfdnchkg fkm tbnohroujstfkons hk wbhob suob shjpchahnmkutrhth`k cfdnchkg ofk dn usnm. (_nn 656.8.) Ncsnwbnrn hk tbhs hssun `a tbnAnmnrfc Tnghstnr, wn frn pudchsbhkg fpr`p`snm rucn tbft whcc fjnkm tbnmnahkhth`k `a f shkgcn-snrvhkg o`ktfhknr,rnquhrn mufc o`cujk cfdnchkg a`r onrtfhk

o`ktfhknrs, upmftn tbn rnanrnkonfj`ukts oust`jfrhcy o`ksujnm fkmsnrvhkg shzns a`r snvnrfc a``m pr`muotoftng`rhns fkm fjnkm tbn snrvhkg shzna`r drnftb jhkts.

Hk 688=, M_BNF dnofjn cfw. Fj`kg`tbnr tbhkgs, M_BNF fjnkmnm snoth`k=5?(q)(>)(A) `a tbn AM&O Fot dy fmmhkgspnohaho rnquhrnjnkts tbft rncftn t` tbncfdnchkg `a mhntfry suppcnjnkt pr`muots.Foo`rmhkgcy, wn fjnkmnm `ur a``mcfdnchkg rngucfth`ks t` nstfdchsbrnquhrnjnkts a`r kutrhth`k cfdnchkg `amhntfry suppcnjnkts ( 656.8(i)(1) fkm656.?1).

]bn rngucft`ry bhst`ry, `ur rfth`kfcna`r nxhsthkg rnquhrnjnkts, fkm AMFfothvhthns rncftnm t` kutrhth`k cfdnchkg `aa``ms fkm mhntfry suppcnjnkts frnmnsorhdnm hk Tnanrnkon 6.

F. Cngfc Futb`rhty

Wn frn pr`p`shkg t` upmftn tbnKutrhth`k Afots cfdnc fkm _uppcnjnktAfots cfdnc, fs snt a`rtb hk tbhs pr`p`snmrucn, o`kshstnkt whtb `ur futb`rhty hksnoth`k =5?(q) `a tbn AM&O Fot. _noth`k=5?(q)(6) `a tbn AM&O Fot stftns tbft fa``m sbfcc dn mnnjnm t` dn jhsdrfkmnm

ha, whtb onrtfhk nxonpth`ks, ht afhcs t`dnfr kutrhth`k cfdnchkg fkm hmnkthahnsspnohaho kutrhnkt fkm ofc`rhn hka`rjfth`krnquhrnm hk cfdnchkg. _noth`k=5?(q)(4)(F) `a tbn AM&O Fot pr`vhmnstbn _norntfry, fkm dy mncngfth`k, AMF,whtb mhsornth`k t` rnquhrn dy rngucfth`kkutrhth`k hka`rjfth`k fd`ut kutrhnkts`tbnr tbfk tb`sn spnohahnm hk snoth`k=5?(q)(6) `a tbn AM&O Fot t` fsshsto`ksujnrs hk jfhktfhkhkg bnfctbymhntfry prfothons. _noth`k =5?(q)(4)(D) `atbn AM&O Fot pnrjhts tbn _norntfry, fkm

dy mncngfth`k, AMF, t` rnj`vnhka`rjfth`k rncfthkg t` f kutrhnktrnquhrnm dy snoth`k =5?(q)(6) `r=5?(q)(4)(F) `a tbn AM&O Fot ha tbn_norntfry mntnrjhkns tbft ht hs k`tknonssfry t` fsshst o`ksujnrs hkjfhktfhkhkg bnfctby mhntfry prfothons.O`kshstnkt whtb tbnsn futb`rhthns, wn frnpr`p`shkg t` rnvhsn onrtfhk kutrhnktmnocfrfth`ks hk tbn Kutrhth`k Afots cfdncfkm _uppcnjnkt Afots cfdnc. Hkfmmhth`k, AMFs futb`rhty hkocumnssnoth`k 4(d)(6) `a tbn 6885 fjnkmjnkts(46 ^._.O. ?=? k`tn). _pnohahofccy,snoth`k 4(d)(6)(F) `a tbn 6885fjnkmjnkts rnquhrns kutrhth`k cfdnchka`rjfth`k dn o`kvnynm hk f jfkknrtbft nkfdcns tbn pudcho t` rnfmhcy`dsnrvn fkm o`jprnbnkm tbnhka`rjfth`k fkm t` ukmnrstfkm htsrncfthvn shgkhahofkon hk tbn o`ktnxt `a ft`tfc mfhcy mhnt. _uob snoth`k stftns tbftsuob hka`rjfth`k sb`ucm dn o`kshstnkt

QnrMftn Jfr36>;4565 68951 And 42, 456= Ilt 4?4556 U@ 55555 Arj 5555> Ajt =756 _ajt =754 N9SATSAJS5?JTU4._GJ 5?JTU4

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6622= Anmnrfc Tnghstnr / Q`c. 78, K`. =6/ J`kmfy, Jfrob ?, 456= / Ur`p`snm Tucns

whtb ourrnkt sohnkthaho lk`wcnmgn fd`utkutrhnkts fkm bnfctb. Wn frn pr`p`shkgobfkgns t` MQs (TMHs fkm MTQs, fsfppchofdcn) a`r s`jn kutrhnkts, wbhobvfcuns frn usnm t` ofcoucftn tbn pnronktMQ a`r usn `k a``m cfdncs. ]bn usn `arnanrnkon vfcuns dfsnm `k ourrnktsohnkon fkm tbn usn `a suob vfcuns t`ofcoucftn tbn pnronkt MQ fsshsts

o`ksujnrs hk o`jprnbnkmhkg tbnkutrhth`k hka`rjfth`k fkm hts rncfthvnshgkhahofkon hk f t`tfc mfhcy mhnt. Wn frnfcs` pr`p`shkg obfkgns t` tbn a`rjftpnrtfhkhkg t` hka`rjfth`k `k tbn pnronktMQ vfcun. Aurtbnr, snoth`k 4(d)(6)(O) `atbn 6885 fjnkmjnkts sthpucftns tbftrngucfth`ks sbfcc pnrjht tbn cfdnc `rcfdnchkg `a a``m t` hkocumn kutrhth`khka`rjfth`k wbhob hs hk fmmhth`k t` tbnhka`rjfth`k rnquhrnm dy suob snoth`k=5?(q) \`a tbn AM&O FotZ fkm wbhob hs`a tbn typn mnsorhdnm hk sudpfrfgrfpb(6)(`r (4) a suob snoth`k . . . . Wn frnpr`p`shkg obfkgns t` tbn v`cuktfry

mnocfrfth`k `a onrtfhk kutrhnkts hk tbnKutrhth`k Afots cfdnc o`kshstnkt whtbsuob futb`rhty.

@tbnr rncnvfkt futb`rhthns hkocumnsnoth`ks 756(f), =5?(f)(6) fkm 456(k) `atbn AM&O Fot (46 ^._.O. ?76(f), 46^._.O. ?=?(f)(6), fkm 46 ^._.O. ?46(k),rnspnothvncy). ^kmnr snoth`k 756(f) `atbn AM&O Fot, tbn Fgnkoy jfy hssunrngucfth`ks a`r tbn naahohnkt nka`ronjnkt`a tbn AM&O Fot hk `rmnr t` naanotuftnf o`kgrnssh`kfc `dinothvn nxprnssnmncsnwbnrn hk tbn Fot (Fss`ohfth`k aFjnrhofk Ubyshohfks fkm _urgn`ks, Hko.v AMF, 441 A. _upp. 4m 45= (M.M.O.4554) (ohthkg Ubfrj. Jars. Fssk. v AMF,

=2= A. _up. 6678, 662? (M. Mnc. 6825).)Wn frn rncyhkg `k `ur futb`rhty ukmnr

snoth`ks =5?(q), =5?(f), 456(k) fkm756(f) `a tbn AM&O Fot, t` pr`p`snrno`rm rnquhrnjnkts t` supp`rt kutrhnktmnocfrfth`ks hk cfdnchkg a`r fmmnmsugfrs, mhntfry ahdnr, s`cudcn ahdnr,hks`cudcn ahdnr, vhtfjhk N, fkm a`cftn/a`cho fohm, ukmnr onrtfhk ohroujstfkons,s` tbft wn ofk mntnrjhkn o`jpchfkonwhtb cfdnchkg rnquhrnjnkts fkm tflnnka`ronjnkt foth`k, fs knnmnm. A`rtbnsn kutrhnkts, fs nxpcfhknm hk snoth`kHH.K., tbnrn hs k` F@FO `aahohfc jntb`m`a fkfcyshs `a F@FO Hktnrkfth`kfc `r

`tbnr rnchfdcn `r fppr`prhftn fkfcythofcpr`onmurn, `tbnrwhsn rnquhrnm dy 656.8(g), fvfhcfdcn a`r AMF t` qufkthaytbn mnocfrnm fj`ukt `a tbn kutrhnkt,ukmnr onrtfhk ohroujstfkons. _noth`k656.8(g) snts a`rtb tbn stfkmfrms a`rfoourfoy `a tbn fj`ukt stftnjnkts `akutrhnkts `k a``m cfdncs. Afhchkg t`foourftncy stftn tbn fj`ukts `a kutrhnkts`k tbn cfdnc ukmnr 656.8(g) w`ucmrnsuct hk f pr`muot dnhkg jhsdrfkmnm.^kmnr snoth`k =5?(q) `a tbn AM&O Fot,f a``m just dnfr, hk hts cfdnc `r cfdnchkg,tbn fj`ukt `a tbn kutrhnkt tbn a``m

o`ktfhks. J`rn`vnr, tbn kutrhnktmnocfrfth`k just dn trutbauc fkm k`tjhscnfmhkg ukmnr snoth`ks =5?(f)(6) fkm456(k) `a tbn AM&O Fot. ]bus, wbnk fa``m pr`muot o`ktfhks mhntfry ahdnr(wbntbnr s`cudcn, hks`cudcn, `r fo`jdhkfth`k `a d`tb) fkm fmmnm k`k-mhgnsthdcn ofrd`bymrftn(s) tbft m`ns k`tjnnt tbn mnahkhth`k `a mhntfry ahdnr, wn

frn pr`p`shkg t` rnquhrn jfkuafoturnrst` jfln fkm lnnp onrtfhk wrhttnkrno`rms t` vnrhay tbn fj`ukt `a fmmnmk`k-mhgnsthdcn ofrd`bymrftn tbft m`nsk`t jnnt tbn mnahkhth`k `a mhntfry. Wbnkvhtfjhk N hs prnsnkt hk f a``m fs fjhxturn `a fcc rfo-f-t`o`pbnr`c fontftnfkm TTT-f-t`o`pbnr`c, wn frn pr`p`shkgt` rnquhrn jfkuafoturnrs t` jfln fkmlnnp wrhttnk rno`rms t` vnrhay tbnfj`ukt `a fcc rfo-f-t`o`pbnr`c fontftnfmmnm t` tbn a``m fkm TTT-f-t`o`pbnr`chk tbn ahkhsbnm a``m. Wbnk f jhxturn `aa`cftn fkm a`cho fohm hs prnsnkt hk f a``m,wn frn pr`p`shkg t` rnquhrn

jfkuafoturnrs t` jfln fkm lnnp rno`rmst` vnrhay tbn fj`ukt `a a`cho fohm fmmnmt` tbn a``m fkm a`cftn hk tbn ahkhsbnma``m. Wbnk fmmnm sugfrs fs wncc fskfturfccy `oourrhkg sugfrs frn prnsnkt hkf a``m, wn frn pr`p`shkg t` rnquhrnjfkuafoturnrs t` jfln fkm lnnp rno`rmst` vnrhay tbn mnocfrnm fj`ukt `a fmmnmsugfrs hk tbn a``m. Ahkfccy, wn frnpr`p`shkg t` rnquhrn jfkuafoturnrs t`jfln fkm lnnp rno`rms t` vnrhay tbnmnocfrnm fj`ukt `a fmmnm sugfrs hkspnohaho a``ms, fc`kn `r hk o`jdhkfth`kwhtb kfturfccy `oourrhkg sugfrs, wbnrntbn fmmnm sugfrs frn sudinot t`anrjnktfth`k.

]bn pr`p`snm rno`rm rnquhrnjnkts a`rtbnsn kutrhnkts, ukmnr tbn ohroujstfkonsmnsorhdnm, frn mnshgknm t` nksurn tbfttbn kutrhnkt mnocfrfth`ks frn foourftn,trutbauc fkm k`t jhscnfmhkg, dfsnm `khka`rjfth`k lk`wk `kcy t` tbnjfkuafoturnr, fkm t` afohchtftn naahohnktfkm naanothvn foth`k t` nka`ron tbnrnquhrnjnkts wbnk knonssfry. @urfutb`rhty t` nstfdchsb rno`rmsrnquhrnjnkts bfs dnnk upbncm ukmnr`tbnr pr`vhsh`ks `a tbn AM&O Fot wbnrnAMF bfs a`ukm suob rno`rms t` dnknonssfry (Kfth`kfc O`kanoth`knrsFss`o. v Ofchafk`, >18 A.4m 185, 18?8=

(M.O. Ohr. 6872). ]bn rno`rms wn pr`p`snt` rnquhrn frn `kcy a`r a``ms a`r wbhobfk fmnquftn fkfcythofc jntb`m hs k`tfvfhcfdcn. ]bn rno`rms w`ucm fcc`w us t`vnrhay tbn mnocfrnm fj`ukt `a nfob `atbnsn kutrhnkts fkm tbft suob fj`ukt hstrutbauc fkm k`t jhscnfmhkg. ]bus, tbnpr`p`snm rno`rms rnquhrnjnkts w`ucmbncp hk tbn naahohnkt nka`ronjnkt `a tbnAM&O Fot.

]bn futb`rhty grfktnm t` AMF ukmnrsnoth`ks 756(f), =5?(q), =5?(f)(6) fkm456(k) `a tbn AM&O Fot k`t `kcyhkocumns futb`rhty t` nstfdchsb rno`rms

rnquhrnjnkts, dut fcs` hkocumns foonsst` suob rno`rms. Whtb`ut suob futb`rhty,tbn kutrhnkt mnocfrfth`ks a`r tbnsnspnohaho kutrhnkts tbft AMF bfsmntnrjhknm frn knonssfry t` fsshsto`ksujnrs hk jfhktfhkhkg bnfctbymhntfry prfothons ukmnr snoth`k=5?(q)(4)(F) `a tbn AM&O Fot frn,prfothofccy spnflhkg, k`t nka`ronfdcn.

Whtb`ut foonss t` suob rno`rms, AMFw`ucm k`t lk`w wbntbnr tbn fj`uktmnocfrnm `k tbn cfdnc `r hk tbn cfdnchkg`a nfob tbnsn kutrhnkts, ukmnr tbnohroujstfkons mnsorhdnm, hs trutbauc fkmk`t jhscnfmhkg ukmnr snoth`ks =5?(f)(6)fkm 456(k) `a tbn AM&O Fot. ]bnhktr`muoth`k `r mnchvnry a`r hktr`muoth`khkt` hktnrstftn o`jjnron `a fjhsdrfkmnm a``m hs f pr`bhdhtnm fotukmnr snoth`k ?56(f) `a tbn AM&O Fot(46 ^._.O. ??6(f)). ]bus, t` mntnrjhknwbntbnr tbn a``m hs jhsdrfkmnm fkm tbnjfkuafoturnr bfs o`jjhttnm fpr`bhdhtnm fot, wn just bfvn foonss t`

tbn jfkuafoturnrs rno`rms tbft wn frnrnquhrhkg dn jfmn fkm lnpt ukmnrsnoth`ks =5?(q), =5?(f)(6), 456(k) fkm756(f) `a tbn AM&O Fot. Afhcurn t` jflnfkm lnnp rno`rms fkm pr`vhmn tbnrno`rms t` AMF, fs mnsorhdnm hkpr`p`snm 656.8(g)(65) fkm (g)(66),w`ucm rnsuct hk tbn a``m dnhkgjhsdrfkmnm ukmnr snoth`ks =5?(q) fkm=5?(f)(6) `a tbn AM&O Fot.

D. Knnm ]` ^pmftn tbn Kutrhth`k Afotsfkm _uppcnjnkt Afots Cfdncs

AMF ahrst hssunm rngucfth`ks rncftnm t`tbn Kutrhth`k Afots cfdnc hk 688?. Wnbfvn k`t upmftnm tbn Kutrhth`k Afots

cfdnc shkon tbn 455? trfks aft rucnjflhkg(12 AT =6=?=< Iucy 66, 455?) `rnstfdchsbnm knw `r upmftnm MQs a`rkutrhnkts shkon 688> (15 AT 1761=). _hkon tbft thjn, tbnpudcho bnfctb pr`ahcn `a tbn ^._.p`pucfth`k bfs obfkgnm (n.g., hkornfsnhk `dnshty), knw hka`rjfth`k bfs dno`jnfvfhcfdcn fd`ut kutrhnkt mnahkhth`ks (n.g.,vhtfjhk N), rnanrnkon hktfln vfcuns, fkmfkfcythofc jntb`ms, fkm knw mhntfryrno`jjnkmfth`ks (snn snoth`k H.D.4.)bfvn dnnk pudchsbnm. Fs f rnsuct, wn frnrno`kshmnrhkg wbft kutrhnkts wn sb`ucmrnquhrn `r pnrjht t` dn chstnm `k tbn

Kutrhth`k Afots cfdnc fkm wbft kutrhnktrnanrnkon hktfln vfcuns wn sb`ucm usn fsf dfshs a`r ofcoucfthkg tbn pnronkt MQshk a``m cfdnchkg. Wn fcs` o`kshmnrnmo`rrnsp`kmhkg obfkgns t` tbn_uppcnjnkt Afots cfdncs. Wn mhsoussspnohaho kutrhnkt mnocfrfth`ks hk grnftnrmntfhc hk snoth`k HH. _noth`k H.D. hkocumnsfk `vnrvhnw `a hka`rjfth`k wno`kshmnrnm wbnk a`rjhkg `ur tnktfthvno`kocush`ks, hkocumhkg sohnkthaho fkmtnobkhofc mftf fkm rno`jjnkmfth`ks,ohthznk pnthth`ks sudjhttnm t` us, fkmpudcho o`jjnkts t` prnvh`us rnqunsts

QnrMftn Jfr36>;4565 68951 And 42, 456= Ilt 4?4556 U@ 55555 Arj 55551 Ajt =756 _ajt =754 N9SATSAJS5?JTU4._GJ 5?JTU4

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6622>Anmnrfc Tnghstnr / Q`c. 78, K`. =6/ J`kmfy, Jfrob ?, 456= / Ur`p`snm Tucns

a`r o`jjnkt hk fmvfkon k`thons `apr`p`snm rucnjflhkg `k t`phos rncftnmt` tbhs pr`p`snm rucn. Wn fcs`o`kshmnrnm tbn r`cn `a kutrhth`k cfdnchkgt` fsshst o`ksujnrs hk jfhktfhkhkgbnfctby mhntfry prfothons fkmo`ksujnrs usn fkm ukmnrstfkmhkg `atbn Kutrhth`k Afots cfdnc.

6. Tftns `a Obr`kho MhsnfsnObr`kho mhsnfsns, suob fs bnfrt

mhsnfsn, ofkonr fkm str`ln frn tbncnfmhkg ofusns `a mnftb fkm mhsfdhchty hktbn ^khtnm _tftns, fkm foo`ukt a`r 75pnronkt `a fcc mnftbs hk tbn ^khtnm_tftns (Tna. 4). Hk 455>, 6?? jhcch`kFjnrhofks, fcj`st `kn `ut `a nvnry tw`fmucts, bfm ft cnfst `kn obr`kho hccknss(Tna. 4). Fk nsthjftnm ?7 pnronkt `aFjnrhofks suaanr ar`j ofrmh`vfsoucfrmhsnfsn (OQM) (Tna. ?), 66.? pnronkt `atbn p`pucfth`k 45 ynfrs fkm `cmnr bfsmhfdntns, ?> pnronkt `a fmucts bfs prn-mhfdntns (Tna. =), fkm =6 pnronkt `a tbnp`pucfth`k hs prnmhotnm t` dn mhfgk`snmwhtb ofkonr murhkg tbnhr chanthjn (Tna.>). Wbhcn tbn ofusns `a tbnsn obr`khomhsnfsns frn jucthafot`rhfc, p``r mhnt hsf o`ktrhduthkg afot`r fss`ohftnm whtbj`rdhmhty fkm j`rtfchty (Tna. 1). Jfkykutrhnkts frn fss`ohftnm whtb obr`khomhsnfsn rhsl. A`r nxfjpcn, mhnts c`w hksfturftnm aft fkm ob`cnstnr`c, fkm/`rs`mhuj frn fss`ohftnm whtb f mnornfsnmrhsl `a OQM (>2 AT 47?8< Ifkufry 1,688?, fkm >2 AT 4245< Ifkufry 1, 688?).Fmnquftn `r hkornfsnm hktfln `a ofcohujfkm vhtfjhk M jfy mnornfsn tbn rhsl `a`stn`p`r`shs (7? AT >1=77< _nptnjdnr48, 4552).

@dnshty rftns bfvn hkornfsnmmrfjfthofccy `vnr tbn cfst tbrnn mnofmns.Dntwnnk 6871 fkm 6825 fkm 4557 fkm4552, `dnshty rftns hkornfsnm j`rn tbfktw`a`cm (ar`j 6> t` ?= pnronkt) hk fmuctsfkm j`rn tbfk tbrnna`cm (ar`j > t` 67pnronkt) fj`kg obhcmrnk fkmfm`cnsonkts (Tnas. 1 t` 2). Mftfpudchsbnm dy tbn ^._. Onktnrs a`rMhsnfsn O`ktr`c fkm Urnvnkth`k (OMO)hkmhoftn tbft 12 pnronkt `a fmucts fkmfd`ut ?4 pnronkt `a obhcmrnk fgnm 4 t`68 ynfrs hk tbn ^._. p`pucfth`k frn`vnrwnhgbt `r `dnsn (Tnas. 7 fkm 2).Nxonsshvn d`my wnhgbt hs f rhsl afot`r a`r

obr`kho mhsnfsns suob fs bnfrt mhsnfsn,s`jn a`rjs `a ofkonr, fkm typn HHmhfdntns (Tna. 8). ]bn 4565 MGFfaahrjnm tbn r`cn `a `vnr o`ksujpth`k `aofc`rhns fkm pbyshofc hkfothvhty fs tbnprhjfry rhsl afot`rs o`ktrhduthkg t` fknphmnjho `a `vnrwnhgbt fkm `dnshty hktbhs o`uktry, fkm urgnm a`r f a`ous `khjpr`vnm kutrhth`k fkm pbyshofcfothvhty ob`hons fj`kg Fjnrhofks (Tna.1).

Ncnvftnm dc``m prnssurn, fk hjp`rtfktrhsl afot`r a`r OQM (Tna. 65), faanotsfd`ut `kn-tbhrm `a tbn ^._. fmuct

p`pucfth`k (Tna. 4). Bhgb hktflns `as`mhuj frn mhrnotcy fss`ohftnm whtbncnvftnm dc``m prnssurn (Tna. 65).Fvnrfgn s`mhuj hktfln a`r tbn ^._.p`pucfth`k = ynfrs `a fgn fkm `cmnr hsfppr`xhjftncy ?,1>5 jg/m (Tna. 66).Fcj`st fcc Fjnrhofks o`ksujn j`rns`mhuj tbfk tbn cnvncs rno`jjnkmnm dytbn 4565 MGF (Tna. 64)

Aurtbnrj`rn, wbhcn o`konrks hk rnonktynfrs bfvn cfrgncy sbhatnm fwfy ar`jkutrhth`kfc mnahohnkohns, s`jnp`pucfth`k sudgr`ups jfy o`ksujnnxonss ofc`rhns dut sthcc o`ksujnhkfmnquftn fj`ukts `a onrtfhkjhor`kutrhnkts suob fs hr`k, vhtfjhk M,ofcohuj fkm p`tfsshuj (snn snoth`kHH.B.).

]bn jfkmft`ry mnocfrfth`k `akutrhnkts tbft bfvn pudcho bnfctbshgkhahofkon, tbn usn `a upmftnm MQs

dfsnm `k ourrnkt sohnkthaho nvhmnkon,fkm tbn usn `a f a`rjft a`r tbn Kutrhth`kAfots cfdnc t` fsshst whtb o`ksujnr usnfkm ukmnrstfkmhkg ofk bncp o`ksujnrsjfln hka`rjnm a``m ob`hons t` o`ksujnf kutrhth`kfccy fmnquftn mhnt wbhcnj`kht`rhkg ofc`rhn hktfln fkm c`wnrhkgtbnhr rhsl `a s`jn obr`kho mhsnfsns.

4. Mhntfry Tno`jjnkmfth`ks, O`ksnksusTnp`rts, fkm Kfth`kfc _urvny Mftf

f. H@J Mhntfry Tnanrnkon HktflnsTnp`rts (H@J MTH Tnp`rts)Hk 688=,tbn A``m fkm Kutrhth`k D`frm (AKD) `atbn Hksthtutn `a Jnmhohkn (H@J)hmnkthahnm prhkohpcns a`r tbnmnvnc`pjnkt `a f knw snt `a rnanrnkonvfcuns tbft o`ucm nxpfkm fkm rnpcfontbn H@Js Tno`jjnkmnm Mhntfry

Fcc`wfkons (TMFs) `a 6828 (Tnas. 6?fkm 6=). F o`jprnbnkshvn rnvhnw fkmfppchofth`k `a f gr`whkg d`my `akutrhth`kfc sohnkon rnsnfrob rnsuctnm hktbn mnvnc`pjnkt `a f snt `a rnanrnkonvfcuns, o`ccnothvncy lk`wk fs MTHs,pudchsbnm ar`j 6887 t` 4565 (Tna. 6>).]bn MTHs rnprnsnkt f sbhat hk tbn wfytbft rnanrnkon vfcuns frn nstfdchsbnm `rhktnkmnm a`r usn. Hk o`ktrfst t` prnvh`usnmhth`ks `a TMFs (n.g., tbn 6812 fkm6828 TMFs), wbhob hkv`cvnmnstfdchsbhkg shkgcn vfcuns a`r nfobkutrhnkt whtb fppr`prhftn fmiustjnktsa`r fgn, snx fkm pbysh`c`ghofc stftus, tbn

knw MTH arfjnw`rl o`kshstnm `a a`uroftng`rhns `a rnanrnkon vfcuns. ]bnsnoftng`rhns hkocumn tbn NsthjftnmFvnrfgn Tnquhrnjnkt (NFT), TMF,Fmnquftn Hktfln (FH) fkm ]`cnrfdcn^ppnr Hktfln Cnvnc (^C). A`rjfor`kutrhnktsofrd`bymrftns, afts,fkm pr`tnhktbn H@J mnvnc`pnm f knwsnt `a rnanrnkon vfcuns ofccnm tbnFoonptfdcn Jfor`kutrhnkt Mhstrhduth`kTfkgns (FJMTs).

]bn NFT hs tbn fvnrfgn mfhcy kutrhnkthktfln cnvnc tbft hs nsthjftnm t` jnnt tbnrnquhrnjnkts `a bfca `a tbn bnfctby

hkmhvhmufcs hk f pfrthoucfr chan stfgn fkmgnkmnr gr`up. NFTs frn usnm a`rfssnsshkg tbn stfthsthofc pr`dfdhchty `afmnqufoy `a kutrhnkt hktflns `a gr`ups`a pn`pcn. ]bn TMF hs fk nsthjftn `a tbnfvnrfgn hktfln cnvnc tbft jnnts tbnkutrhnkt rnquhrnjnkts `a knfrcy fcc (87t` 82 pnronkt) bnfctby hkmhvhmufcs hk fpfrthoucfr chan stfgn fkm gnkmnr gr`up.

]bn TMF hs snt ushkg tbn NFT. Hkgnknrfc, tbn TMF hs tbn NFT pcus tw`thjns tbn stfkmfrm mnvhfth`k `a tbn NFT.]bn TMF hs usnm t` pcfk kutrhnkthktflns a`r hkmhvhmufcs t` nksurn f c`wpr`dfdhchty `a hkfmnqufoy. Kutrhnktswhtb NFTs fkm TMFs hkocumnofrd`bymrftn, pr`tnhk, vhtfjhk F,vhtfjhk O, vhtfjhk N, tbhfjhk,rhd`acfvhk, khfohk, vhtfjhk D1, a`cftn,vhtfjhk D64, o`ppnr, h`mhkn, hr`k,jfgknshuj, pb`spb`rus, sncnkhuj,zhko, ofcohuj fkm vhtfjhk M.

Fk FH hs tbn cnvnc mntnrjhknm a`r fknssnkthfc kutrhnkt `r f kutrhnkt tbft hs

dnknahohfc a`r bujfk bnfctb wbnk tbnrnhs hksuaahohnkt nvhmnkon t` ofcoucftn fkNFT a`r tbft kutrhnkt, fkm tbnrna`rnhksuaahohnkt nvhmnkon `k wbhob t`nstfdchsb fk TMF. FHs ofk dn dfsnm `kf vfrhnty `a mftf, hkocumhkg sohnkthahonvhmnkon fd`ut tbn nssnkthfchty `a fkutrhnkt (h.n., ob`chkn, dh`thk, acu`rhmn),nxpnrhjnktfc mftf `k rhsl rnmuoth`k `aobr`kho mhsnfsn (h.n., mhntfry ahdnr,p`tfsshuj), fkm jnmhfk hktflns `a fkutrhnkt ushkg kfth`kfc survny mftf (h.n.,vhtfjhk L, pfkt`tbnkho fohm, obr`jhuj,jfkgfknsn, chk`cnho fohm, fkm \fcpbfZ-chk`cnkho fohm). Fctb`ugb tbnrn hs cnssonrtfhkty fd`ut fk FH vfcun tbfk fd`ut

fk TMF vfcun, tbn FH hs shjhcfrcymnshgknm t` o`vnr tbn knnms `a knfrcy fcchkmhvhmufcs. ]bn H@J Mhntfry UcfkkhkgTnp`rt fkm Mhntfry Fssnssjnkt Tnp`rtk`tnm tbft tbn FH sb`ucm dn usnm whtbcnss o`kahmnkon ha ht bfs k`t dnnknstfdchsbnm fs tbn jnfk hktfln `a fbnfctby gr`up.

]bn ^C hs tbn bhgbnst fvnrfgn mfhcyhktfln cnvnc chlncy t` p`sn k` rhsl `afmvnrsn bnfctb naanots a`r knfrcy fccpn`pcn hk f pfrthoucfr gr`up. ]bn ^C hsk`t hktnkmnm t` dn f rno`jjnkmnm cnvnc`a hktfln. ]bn ^C hs usnm t` fssnss tbnrhsl `a fmvnrsn bnfctb naanots ar`j

nxonsshvn kutrhnkt hktfln. Fs hktflnfd`vn tbn ^C hkornfsns, s` m`ns tbnp`tnkthfc a`r rhsl `a fmvnrsn bnfctbnaanots. Kutrhnkts whtb ^Cs hkocumnvhtfjhk F, vhtfjhk O, vhtfjhk M,vhtfjhk N, khfohk, vhtfjhk D1, a`cftn,ob`chkn, ofcohuj, o`ppnr, acu`rhmn,h`mhkn, hr`k, jfgknshuj, jfkgfknsn,j`cydmnkuj, pb`spb`rus, sncnkhuj,zhko, s`mhuj, fkm obc`rhmn.

J`rn`vnr, wbhcn tbn prnvh`us TMFsprhjfrhcy a`ousnm `k rnmuohkg tbnhkohmnkon `a mhsnfsns `a kutrhnktmnahohnkoy hk tbn p`pucfth`k, tbn MTHs

QnrMftn Jfr36>;4565 68951 And 42, 456= Ilt 4?4556 U@ 55555 Arj 55557 Ajt =756 _ajt =754 N9SATSAJS5?JTU4._GJ 5?JTU4

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66221 Anmnrfc Tnghstnr / Q`c. 78, K`. =6/ J`kmfy, Jfrob ?, 456= / Ur`p`snm Tucns

k`w tfln hkt` o`kshmnrfth`k mftf `kobr`kho mhsnfsn rhsl, suob fs bnfrtmhsnfsn, fkm mnvnc`pjnktfcfdk`rjfchthns, suob fs tnrft`gnkhohty,rftbnr tbfk `kcy tbn shgks `a mnahohnkoy.Ahkfccy, wbnrn suaahohnkt mftf nxhst, tbnMTHs tfln hkt` foo`ukt tbn p`tnkthfc

dnknaht `r rhsl t` bnfctb a sudstfkonstbft frn k`t nssnkthfc (suob fs mhntfry

ahdnr fkm acu`rhmn) tbft frn hk fmmhth`kt` tbn jfor`kutrhnkts `a t`tfcofrd`bymrftn, pr`tnhk, fkm aft, fkm tbnjhor`kutrhnkt vhtfjhks fkm jhknrfcspnrjhttnm `r rnquhrnm `k tbn Kutrhth`kAfots cfdnc (Tna. 6>). Dnghkkhkg hk 6887,tbn H@J dngfk pudchsbhkg hts MTHs a`rtb`sn vhtfjhks, jhknrfcs, fkmjfor`kutrhnkts tbft frn nssnkthfc hkbujfks `r pr`vhmn f dnknahohfc r`cn hkbujfk bnfctb (Tnas. 61 t` 44). Hkfmmhth`k, tbn H@J fcs` snt FJMTs a`rofrd`bymrftns, aft, fkm pr`tnhk (Tna. 4?).]bn FJMT a`r f jfor`kutrhnkt hs dfsnm`k tbn fj`ukt `a tbn jfor`kutrhnkt tbft

hs fss`ohftnm whtb f rnmuonm rhsl `aobr`kho mhsnfsn wbhcn pr`vhmhkgfmnquftn hktflns `a nssnkthfc kutrhnkts.]bn FJMT hs nxprnssnm fs f rfkgn `apnronkt nknrgy hktfln (n.g., 45 t` ?>pnronkt `a ofc`rhns ar`j t`tfc aft a`rfmucts `vnr 62 ynfrs `a fgn). ]bn MTHsfkm FJMTs wnrn snt a`r tbn a`cc`whkgchan stfgn gr`ups9 Hkafkts (5 t` 1 fkm 7t` 64 j`ktbs)< t`mmcnrs (6 t` ? ynfrs)5, >6 t` 75, fkm grnftnr tbfk 75ynfrs)< fkm prngkfkt fkm cfotfthkgw`jnk.

d. H@J Mhntfry Ahdnr Tnp`rtHk 4556,tbn H@J Ufknc `k tbn Mnahkhth`k `aMhntfry Ahdnr (tbn H@J Mhntfry AhdnrUfknc) rnsp`kmnm t` `ur rnqunst t`pr`vhmn mnahkhth`ks a`r mhntfry ahdnr

dfsnm `k hts r`cn hk bujfk pbysh`c`gyfkm bnfctb. ]bn H@J Mhntfry Ahdnr Ufkncmnvnc`pnm tw` oftng`rhns `a mnahkhth`ks`a ahdnr9 Mhntfry Ahdnr fkm FmmnmAhdnr hk hts rnp`rt Mhntfry TnanrnkonHktflns9 Ur`p`snm Mnahkhth`k `a MhntfryAhdnr (tbn H@J Mhntfry Ahdnr Tnp`rt)(Tna. 4=).

o. H@J Mhntfry Fssnssjnkt Tnp`rtHk4555, tbn H@J _udo`jjhttnn `k

Hktnrprntfth`k fkm ^sns `a MhntfryTnanrnkon Hktflns (H@J usns O`jjhttnn)pudchsbnm tbn rnp`rt, MTHs Fppchofth`khk Mhntfry Fssnssjnkt (H@J MhntfryFssnssjnkt rnp`rt) `k b`w t` usn tbnMTHs a`r mhntfry fssnssjnkt `ahkmhvhmufcs fkm gr`ups.

m. H@J Cfdnchkg Tnp`rtHk 455?, tbnH@J O`jjhttnn `k kutrhth`k cfdnchkg(H@J Cfdnchkg O`jjhttnn) o`kshmnrnmb`w tbn MTHs ofk dn usnm t` mnvnc`pfppr`prhftn rnanrnkon vfcuns a`rkutrhth`k cfdnchkg fkm pudchsbnm htsrnp`rt, o`-aukmnm dy AMF, MTH Guhmhkg

Urhkohpcns a`r Kutrhth`k Cfdnchkg fkmA`rthahofth`k (tbn H@J Cfdnchkg Tnp`rt)(Tna. 4>), whtb tbn g`fc `a bfvhkg fkupmftnm kutrhth`k cfdnc tbft o`ksujnrsofk usn t` jfln hka`rjnm mhntfryob`hons.

n. H@J Mhntfry Ucfkkhkg Tnp`rtHk455?, tbn H@J _udo`jjhttnn `khktnrprntfth`k fkm usns `a MTHs (H@J

^sns O`jjhttnn) pudchsbnm f rnp`rt,MTHs Fppchofth`k hk Mhntfry Ucfkkhkg(H@J Mhntfry Ucfkkhkg Tnp`rt) (Tna. 41)`k b`w t` usn tbn MTHs a`r pcfkkhkghktflns `a hkmhvhmufcs fkm gr`ups. ]bhsrnp`rt mhsoussns tbn usn `a tbn MTHs a`ra``m fkm suppcnjnkt cfdncs.

a. H@J _`mhuj _trftnghns Tnp`rtHk4552, tbn H@J o`kvnknm f O`jjhttnn`k _trftnghns t` Tnmuon _`mhuj Hktflnhk tbn ^khtnm _tftns t` fmmrnss fO`kgrnssh`kfc rnqunst a`rrno`jjnkmfth`ks fd`ut vfrh`us jnfkstbft o`ucm dn njpc`ynm t` rnmuonmhntfry s`mhuj hktfln t` cnvncsrno`jjnkmnm dy tbn 455> MGF (cnsstbfk 4,?55 jg/m fkm k` j`rn tbfk 6,>55jg/m a`r Farhofk-Fjnrhofks, pn`pcnwhtb bypnrtnksh`k, fkm jhmmcn-fgnmfkm `cmnr fmucts). ]bn O`jjhttnnsrnp`rt, _trftnghns t` Tnmuon _`mhujHktfln hk tbn ^khtnm _tftns (H@J_`mhuj _trftnghns Tnp`rt), pudchsbnm hk4565, fj`kg `tbnr strftnghns, mhsoussnsb`w tbn cfdnchkg `a s`mhuj `k a``ms ofksnrvn fs f supp`rthkg strftngy a`rrnmuohkg s`mhuj hktfln (Tna. 47).

g. H@J Ar`kt-@a-Ufolfgn Kutrhth`kTfthkg _ystnjs fkm _yjd`cs Ubfsn Hfkm Ubfsn HH Tnp`rtsHk 4565, tbn H@JO`jjhttnn `k Ar`kt-`a-Ufolfgn (A@U)

Kutrhth`k Tfthkg _ystnjs fkm _yjd`csrnvhnwnm tbn nxhsthkg A@U systnjs fkmtbnhr ukmnrcyhkg kutrhth`k orhtnrhf. Hk tbnUbfsn H rnp`rt, tbn H@J hmnkthahnm tbnkutrhnkts a`r wbhob tbnrn wfs suaahohnktnvhmnkon `a tbnhr r`cn hk obr`kho mhsnfsnrhsl fkm wbhob sb`ucm dn hkocumnm hk fA@U cfdnc (Tna. 42). Hk 4564, tbn H@Jpudchsbnm hts pbfsn HH rnp`rt tbftrno`jjnkmnm mnvnc`phkg f shkgcnstfkmfrmhznm A@U rfthkg systnj fkmupmftnm tbnhr rno`jjnkmfth`ks a`rkutrhnkts t` dn hkocumnm `k tbn A@Ucfdnc (Tna. 48).

b. H@J _`mhuj Hktfln hk U`pucfth`ks

Tnp`rtHk 4564 tbn H@J o`kvnknm fO`jjhttnn t` rnvhnw fkm fssnss tbndnknahts fkm fmvnrsn `uto`jns (ha fky)`a rnmuohkg tbn s`mhuj hktfln hk tbnp`pucfth`k, pfrthoucfrcy hk tbn rfkgn `a6,>55 t` 4,?55 jg/m. ]bn O`jjhttnnwfs fcs` fslnm t` spnohahofccy njpbfshznrncnvfkt sudgr`ups hk tbn fkfcyshshkocumhkg tb`sn >5 ynfrs `a fgn fkm`cmnr, Farhofk Fjnrhofks, fkm tb`snwhtb mhfdntns, obr`kho lhmkny mhsnfsn,fkm o`kgnsthvn bnfrt afhcurn. ]bn Tnp`rtwfs pudchsbnm hk Jfy `a 456? fkma`ousnm hts ahkmhkgs fkm o`kocush`ks `k

nvhmnkon a`r fss`ohfth`ks dntwnnks`mhuj hktfln fkm tbn rhsl `a OQM-rncftnm nvnkts fkm j`rtfchty.

h. Mhntfry Guhmnchkns a`r Fjnrhofks(MGF), 4565]bn 4565 MGF,mnvnc`pnm i`hktcy dy tbn ^._.Mnpfrtjnkt `a Fgrhoucturn (^_MF) fkmtbn ^._. Mnpfrtjnkt `a Bnfctb fkmBujfk _nrvhons (BB_), pr`vhmn snvnrfc

lny rno`jjnkmfth`ks hkocumhkgrno`jjnkmfth`ks fd`ut mhntfrypfttnrks, fs wncc fs qufkthtfthvn hktflnrno`jjnkmfth`ks whtb rnspnot t`jhor`kutrhnkts fkm jfor`kutrhnkts,j`st `a wbhob frn dfsnm `k tbn H@J MTHrnp`rts (Tna. 1). Hk f anw ofsns, tbn 4565MGF pr`vhmnm qufkthtfthvn hktflnrno`jjnkmfth`ks a`r onrtfhk kutrhnkts(h.n., ob`cnstnr`c fkm sfturftnm aft) tbftwnrn k`t pr`vhmnm dy tbn H@J MTHrnp`rts (Tna. 1). ]bn 4565 MGFnjpbfshznm tbn hjp`rtfkon `a jnnthkga``m fkm kutrhnkt rno`jjnkmfth`kswbhcn dfcfkohkg ofc`rhn knnms (Tna. 1).

J`rn hka`rjfth`k rngfrmhkg tbnsohnkthaho dfshs tbft hka`rjnm tbnmnvnc`pjnkt `a tbn 4565 MGF ofk dna`ukm hk tbn Tnp`rt `a tbn MhntfryGuhmnchkns Fmvhs`ry O`jjhttnn `k tbnMhntfry Guhmnchkns a`r Fjnrhofks, 4565(4565 MGFO) (Tna. ?5). Fk hjp`rtfktk`tn rncftnm t` tbn 4565 MGF hs tbnspnohahnm hktnkmnm fumhnkon a`r htsrno`jjnkmfth`ks (Tna. 1). Ar`j tbn6825s ukthc 688>, tbn MGFs wnrntfrgntnm t`wfrm bnfctby Fjnrhofks fkmmnshgknm t` pr`vhmn fmvhon t` bnfctbyhkmhvhmufcs fd`ut a``m ob`hons tbftpr`j`tn bnfctb fkm prnvnkt mhsnfsn(Tnas. ?6 t` ?=). Hk 4555, tbn

rno`jjnkmfth`ks spnohahnm fk fumhnkon`a bnfctby obhcmrnk fgns 4 ynfrs fkm`cmnr fkm fmucts `a fky fgn, fkm tbn455> MGF pr`vhmnm rno`jjnkmfth`ksa`r tbn gnknrfc pudcho fgn 4 ynfrs fkm`cmnr. (Tnas. ?> fkm ?1). Wbhcn tbnMGFs bfvn fcwfys tflnk hkt` foo`ukttbn knnms `a sudp`pucfth`ks, tbn j`strnonkt 4565 MGF g`ns dny`km tbntrfmhth`kfc tfrgnt `a f bnfctbyfumhnkon t` pr`vhmn obr`kho mhsnfsn,k`thkg tbn rnfchty tbft f cfrgnpnronktfgn `a Fjnrhofks frn `vnrwnhgbt`r `dnsn fkm/`r ft rhsl `a vfrh`usobr`kho mhsnfsns (Tna. 1).

i. Kfth`kfc Bnfctb fkm Kutrhth`kNxfjhkfth`k _urvny (KBFKN_)]bnKBFKN_ pr`vhmns tbn prhjfry s`uron`a hka`rjfth`k `k tbn bnfctb fkmkutrhth`kfc stftus `a fmucts fkm obhcmrnkhk tbn ^khtnm _tftns. ]bn survnynxfjhkns f kfth`kfccy rnprnsnktfthvnsfjpcn `a fd`ut >,555 pnrs`ks nfobynfr. ]bnsn pnrs`ks frn c`oftnm hko`ukthns for`ss tbn o`uktry. ]bn survnyo`jdhkns hktnrvhnws, wbhob hkocumnmnj`grfpbho, s`oh`no`k`jho, mhntfry,fkm bnfctb-rncftnm qunsth`ks, fkmpbyshofc nxfjhkfth`ks, wbhob o`kshst `a

QnrMftn Jfr36>;4565 68951 And 42, 456= Ilt 4?4556 U@ 55555 Arj 55552 Ajt =756 _ajt =754 N9SATSAJS5?JTU4._GJ 5?JTU4

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66227Anmnrfc Tnghstnr / Q`c. 78, K`. =6/ J`kmfy, Jfrob ?, 456= / Ur`p`snm Tucns

jnmhofc, mnktfc, fkm pbysh`c`ghofcjnfsurnjnkts, fs wncc fs cfd`rft`rytnsts fmjhkhstnrnm dy bhgbcy trfhknmjnmhofc pnrs`kknc (Tna. ?7).

?. O`ksujnr ^sn fkm ^kmnrstfkmhkg `atbn Kutrhth`k Afots Cfdnc

]bn Kutrhth`k Afots cfdnc hs hktnkmnmt` bncp o`ksujnrs jfln hka`rjnm a``m

ob`hons fkm jfhktfhk bnfctby mhntfryprfothons. O`ksujnrs dnofjnhkornfshkgcy fwfrn `a tbn knw cfdnc hktbn ynfrs a`cc`whkg hjpcnjnktfth`k `atbn 6885 fjnkmjnkts, fkm rnp`rtnmushkg a``m cfdncs j`rn `atnk hk tbnhrpurobfshkg mnohsh`ks o`jpfrnm t` tbnhrusn dna`rn tbn hktr`muoth`k `a tbnKutrhth`k Afots cfdnc (Tna. ?2).

Mftf ar`j f kfth`kfccy rnprnsnktfthvnsfjpcn `a ^._. fmucts o`ccnotnm tbr`ugbAMFs Bnfctb fkm Mhnt _urvnys suggnsttbft tbn arnqunkoy `a a``m cfdnc usnfj`kg o`ksujnrs pr`grnsshvncyhkornfsnm dntwnnk 4554 fkm 4552 (Tnas.?8 t` =6). A`r nxfjpcn, tbn pnronktfgn`a o`ksujnrs rnp`rthkg tbft tbny `atnkrnfm f a``m cfdnc tbn ahrst thjn tbnypurobfsn f a``m pr`muot r`sn ar`j ==pnronkt hk 4554 t` >= pnronkt hk 4552.Fj`kg tb`sn hkmhofthkg tbny rnfm a``mcfdncs wbnk purobfshkg f pr`muot a`rtbn ahrst thjn, tw`-tbhrms `a tbnj hk4552 rnp`rtnm ushkg tbn cfdnc t` snn b`wbhgb `r c`w tbn a``m wfs hk ofc`rhns,sfct, vhtfjhks `r aft, wbhcn j`rn tbfkbfca sfhm tbny usnm cfdncs t` gnt fgnknrfc hmnf `a tbn kutrhth`kfc o`ktnkt `atbn pr`muot. F shjhcfr hkornfsn hkrnp`rtnm usn `a a``m cfdncs bfs fcs` dnnksb`wk ushkg mftf ar`j tbn Kfth`kfc

Bnfctb fkm Kutrhth`k Nxfjhkfth`k_urvnys 45574552 fkm 45586565. ]bnpnronkt `a w`rlhkg fgn fmucts tbftrnp`rtnm ushkg tbn Kutrhth`k Afots Ufknc(KAU) fcwfys `r j`st `a tbn thjn wbnksb`pphkg a`r a``m hkornfsnm t` =4% hk45584565 ar`j ?=% hk 45574552.Fj`kg `cmnr fmucts tbn pnronktfgnhkornfsnm t` >7% hk 45584565 ar`j>6% hk 45574552. (Tna. =4).

O`ksujnr rnsnfrob mftf suggnst tbft,mnsphtn tbn whmnsprnfm usn `a a``mcfdncs, onrtfhk ncnjnkts `a tbn Kutrhth`kAfots cfdnc jfy knnm hjpr`vnjnkt. A`rnxfjpcn, s`jn o`ksujnrs bfvn

mhaahoucty ukmnrstfkmhkg tbn o`konpt `apnronkt MQ (Tnas. =? fkm ==) `r frno`kausnm dy tbn cfdnc a``tk`tn tbft chstsMQs a`r onrtfhk kutrhnkts dfsnm `k f4,555 fkm 4,>55 ofc`rhn mhnt (Tna. =>).

_noth`k 4(d)(6)(F) `a tbn 6885fjnkmjnkts jfkmftnm tbft AMFrngucfth`ks hjpcnjnkthkg snoth`k =5?(q)`a tbn AM&O Fot rnquhrn tbft kutrhth`kcfdnchkg just dn o`kvnynm t` tbn pudchohk f jfkknr wbhob nkfdcns tbn pudcho t`rnfmhcy `dsnrvn fkm o`jprnbnkm suobhka`rjfth`k fkm t` ukmnrstfkm htsrncfthvn shgkhahofkon hk tbn o`ktnxt `a f

t`tfc mfhcy mhnt. Hk pfrthoucfr, tbnpnronkt MQ `a f kutrhnkt prnsnkt hk a``mhs mnocfrnm `k a``m cfdncs t` bncpo`ksujnrs ukmnrstfkm tbn rncfthvnshgkhahofkon `a kutrhth`k hka`rjfth`k hktbn o`ktnxt `a f t`tfc mfhcy mhnt, o`jpfrntbn kutrhth`kfc vfcuns `a a``m pr`muots,fkm t` pcfk gnknrfc mhnts (>2 AT 4451 ft446?< Ifkufry 1, 688?). Wn fcs` k`tnm

tbft tbn pnronkt MQ hka`rjfth`k fmvhsnstbn o`ksujnr b`w juob `a frno`jjnkmnm hktfln `a tbft kutrhnkt hspr`vhmnm dy tbn a``m (>2 AT 4578 ft464?< Ifkufry 1, 688?). Wn mnvnc`pnmtbn tnrj Mfhcy Qfcun t` rnanr t` fccrnanrnkon vfcuns `k tbn kutrhth`k cfdnc(MTQs fkm TMHs). Wn k`tnm tbft s`jn `atbn rnanrnkon vfcuns wnrn hktnkmnm t`guhmn o`ksujnrs rncfthvn t` jfxhjujhktflns (MTQs) (n.g., sfturftnm aft), wbhcn`tbnrs wnrn hktnkmnm t` snrvn fs tbn

dfshs a`r pcfkkhkg gnknrfc mhnts t` jnntkutrhnkt rnquhrnjnkts (TMHs) (n.g.,vhtfjhk O) (>2 AT 4578 ft 464=). @ur

rnsnfrob ft tbn thjn sb`wnm tbft tbntnrj Mfhcy Qfcun wfs gnknrfccyukmnrst``m dy o`ksujnrs fs f p`hkt `arnanrnkon (>2 AT 4578 ft 464>).

Hk `rmnr t` mntnrjhkn f kutrhth`kcfdnchkg a`rjft tbft o`ucm dn usnm j`stnaanothvncy dy o`ksujnrs, wn o`kmuotnmo`ksujnr rnsnfrob fkm nvfcuftnmrnsnfrob o`kmuotnm dy `tbnrs hko`kshmnrhkg rnquhrnjnkts a`r tbnkutrhth`k cfdnc a`rjft (>2 AT 4578 ft466>4646). Wbnk fvfhcfdcn, wn usnmnjphrhofc mftf `k b`w o`ksujnrs usnfkm ukmnrstfkm tbn cfdnc hk pr`p`shkgwbft hka`rjfth`k sb`ucm dn mnocfrnm `ktbn cfdnc fkm b`w. Wn usnm a`ous gr`up

mftf t` hka`rj wbft wn w`ucm tnst hknxpnrhjnktfc stumhns, dut mhm k`t rncy`k suob mftf t` jfln p`choy mnohsh`ks._nvnrfc o`jjnkts t` tbn FKUTJssudjhttnm a`ous gr`up mftf. B`wnvnr,wn frn k`t rncyhkg `k a`ous gr`up mftfa`r tbn pr`p`snm obfkgns t` tbnKutrhth`k Afots cfdnc dnofusn a`ousgr`ups m` k`t yhncm jnfkhkgaucqufkthtfthvn ahkmhkgs fkm frn k`t fdcn t`supp`rt o`kocush`ks fd`ut tbnrncfth`ksbhps dntwnnk tbn prnsnktfth`k`a cfdnc hka`rjfth`k fkm o`ksujnrrnsp`ksns. Fs suob, tbny ofkk`t dn usnmt` mrhvn tbn mnvnc`pjnkt `a p`chohns,

pr`grfjs, fkm snrvhons. U`choy jflnrsfkm nmuoft`rs ofk usn a`ous gr`upsahkmhkgs t` tnst fkm rnahkn tbnhr hmnfs,

dut sb`ucm tbnk o`kmuot aurtbnrrnsnfrob dna`rn jflhkg hjp`rtfktmnohsh`ks suob fs fm`pthkg knw p`chohnsfkm fcc`ofthkg `r rnmhrnothkg shgkhahofktrns`urons t` supp`rt tbnsn p`chohns.

Wn bfvn o`jpcntnm `kn stumy tbftnxfjhknm mufc-o`cujk cfdncs fkm wfyst` hkornfsn pr`jhknkon `a onrtfhk cfdnchka`rjfth`k, fkm hktnkm t` o`kthkun t`pnra`rj rnsnfrob murhkg tbhs rucnjflhkgpr`onss t` nvfcuftn b`w vfrhfth`ks hk

cfdnc a`rjft jfy faanot o`ksujnrukmnrstfkmhkg fkm usn `a tbn Kutrhth`kAfots cfdnc. Hssuns t` dn fmmrnssnmhkocumn b`w f mnocfrfth`k `a Fmmnm_ugfrs fkm fctnrkfthvn a``tk`tnstftnjnkt jfy hkacunkon o`ksujnr usn`a tbn cfdnc.

]bn `vnrfcc g`fc `a tbnsn stumhns hs t`fssnss f o`ksujnrs fdhchty t` usn tbn

Kutrhth`k Afots cfdnc fkm fssnss fo`ksujnrs prnanrnkons rncftnm t`pr`p`snm j`mhahofth`ks `a tbn Kutrhth`kAfots cfdnc a`rjft. Hk fmmhth`k, tbnstumhns whcc bncp us a`ous `ur naa`rts `ko`ksujnr nmuofth`k fs wncc fs nkbfkon`ur ukmnrstfkmhkg `a wbntbnrj`mhahofth`ks t` tbn Kutrhth`k Afotscfdnc a`rjft o`ucm bncp o`ksujnrs jflnj`rn hka`rjnm ob`hons dfsnm `k tbnhrpnronpth`ks `a tbn kutrhth`kfc fttrhdutnsfkm `vnrfcc bnfctbaucknss `a f a``mpr`muot. (_nn fcs` mhsoussh`k hk snoth`kHH.J.)

=. @tbnr Tncnvfkt O`kshmnrfth`ks

Hk mnvnc`phkg tbhs pr`p`snm rucn, wno`kshmnrnm obfkgns tbft w`ucm fsshsto`ksujnrs hk jfhktfhkhkg bnfctbymhntfry prfothons fkm rno`gkhzn tbft ht hshjp`rtfkt a`r tbn upmftnm Kutrhth`kAfots cfdnc t` dn usnauc fkm rncnvfkt t`tbn Fjnrhofk p`pucfth`k. Wbhcn tbnKutrhth`k Afots cfdnc hka`rjfth`k bfsknvnr dnnk k`r hs ht k`w tfrgntnm t`hkmhvhmufcs whtb foutn `r obr`khomhsnfsn, wn frn o`kshmnrhkg tbn cfrgnp`rth`k `a tbn ^._. p`pucfth`k tbft hs ftrhsl a`r obr`kho mhsnfsn hk pr`p`shkgobfkgns t` tbn cfdncs o`ktnkt fkma`rjft. ]bn p`pucfth`k ft rhsl a`r

obr`kho mhsnfsn hkocumns tb`sn wb` frn`vnrwnhgbt, fkm tbnrna`rn ft hkornfsnmrhsl `a onrtfhk obr`kho mhsnfsns, `r tb`snwb` frn `dnsn, cnfmhkg t` f vfrhnty `ao`jpchofth`ks hkocumhkg mhfdntns fkmOQM. ]bhs fppr`fob hs o`kshstnkt whtbtbn knw H@J MTHs, wbhob frn a`rbnfctby hkmhvhmufcs, hkocumhkg tb`sn ft-rhsl `a mhsnfsn, dut k`t a`r hkmhvhmufcswhtb foutn `r obr`kho mhsnfsn `r kutrhnktmnahohnkohns (Tna. 6>). _hjhcfrcy, tbnMGFs frn a`r Fjnrhofks fgns 4 ynfrsfkm `cmnr, hkocumhkg tb`sn ft rhsl `aobr`kho mhsnfsn. Wbhcn o`ksujnrs whtbfoutn `r obr`kho mhsnfsn, suob fs

`dnshty, OQM, `r mhfdntns, jfy dn fdcnt` usn qufkthtfthvn hka`rjfth`k `k tbncfdnc t` a`cc`w fmvhon tbny bfvnrnonhvnm ar`j f bnfctb ofrn pr`anssh`kfco`konrkhkg tbnhr o`kmhth`ks, tbnkutrhnkt mnocfrfth`ks fkm pnronkt MQs`k tbn cfdnc frn t` bncp o`ksujnrs jflnj`rn hka`rjnm ob`hons t` o`ksujn fbnfctby mhnt fkm k`t hktnkmnm a`r tbnochkhofc jfkfgnjnkt `a fk nxhsthkgmhsnfsn. Hk fmmhth`k, wn rno`gkhzn tbnhjp`rtfkon `a anmnrfc rngucfth`ksrnacnothkg tbn j`st ourrnkt sohnkon. Hkmnvnc`phkg tbhs pr`p`snm rucn, wn

QnrMftn Jfr36>;4565 68951 And 42, 456= Ilt 4?4556 U@ 55555 Arj 55558 Ajt =756 _ajt =754 N9SATSAJS5?JTU4._GJ 5?JTU4

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66222 Anmnrfc Tnghstnr / Q`c. 78, K`. =6/ J`kmfy, Jfrob ?, 456= / Ur`p`snm Tucns

o`kshmnrnm knw sohnkthaho nvhmnkon fkmmhntfry rno`jjnkmfth`ks fd`ut tbnrncfth`ksbhp dntwnnk kutrhnkts fkmbnfctb.

Ahkfccy, wn rno`gkhzn tbft tbn g`fc `afsshsthkg o`ksujnrs hk jfhktfhkhkgbnfctby mhntfry prfothons rnquhrns tbftwn o`kshmnr onrtfhk prfothofchthns. A`rnxfjpcn, fs wn k`tnm hk tbn 688?

kutrhnkt o`ktnkt ahkfc rucn (>2 AT 4578ft 4657), wbhcn tbn 6885 fjnkmjnktspnrjht tbn _norntfry `a Bnfctb fkmBujfk _nrvhons t` hkocumn hk tbnKutrhth`k Afots cfdnc fky hka`rjfth`kfd`ut f kutrhnkt tbft whcc fsshsto`ksujnrs hk jfhktfhkhkg bnfctbymhntfry prfothons, tbnrn hs k`t r``j `ktbn cfdnc a`r fcc hka`rjfth`k tbft jfy dnrncftnm t` jfhktfhkhkg bnfctby mhntfryprfothons. _pfon o`kstrfhkts `k tbn cfdnc`a j`st a``ms jfln mnocfrhkg fccnssnkthfc kutrhnkts hjprfothofc. Hkfmmhth`k, bfvhkg f cfrgn fj`ukt `ahka`rjfth`k `k tbn cfdnc o`ucm hktnranrn

whtb o`ksujnrs fdhchthns t` usn tbnhka`rjfth`k tbft bfs tbn grnftnst pudchobnfctb shgkhahofkon. ]bnrna`rn, k`t `kcyfrn wn fwfrn `a tbn fj`ukt fkm a`rjft`a jfkmft`ry hka`rjfth`k `k tbn cfdnc,

dut wn rno`gkhzn tbft chjhts t` tbnv`cuktfry hka`rjfth`k frn knonssfry, s`tbft v`cuktfry hka`rjfth`k m`ns k`tocuttnr tbn cfdnc, m`ns k`t jhscnfm,o`kausn, `r `vnrwbncj tbn o`ksujnr,fkm m`ns k`t tfln fwfy pr`jhknkon `afkm njpbfshs `k tbn rnquhrnmhka`rjfth`k.

>. Ohthznk Unthth`ks

_hkon 688?, wn rnonhvnm f kujdnr `a

ohthznk pnthth`ks rnqunsthkg tbft AMFjfln vfrh`us obfkgns t` tbn Kutrhth`kfkm _uppcnjnkt Afots cfdncs. Wn frnfmmrnsshkg f kujdnr `a hssuns rfhsnm hktbn a`cc`whkg pnthth`ks whtbhk tbhspr`p`snm rucn9 (6) ]bn Ofc`rhn O`ktr`cO`ukohc sudjhttnm f ohthznk pnthth`k `kFprhc 6?, 688> (M`olnt K`. AMF688>U56=4) rnqunsthkg tbft AMF pnrjht tbnusn `a tbn tnrj p`cy`cs hk chnu `asugfr fco`b`cs `k tbn Kutrhth`k Afotscfdnc (bttp9//www.rngucfth`ks.g`v/#!m`olntMntfhc-U-56=4)< (4)tbn Fjnrhofk O`o`f Tnsnfrob Hksthtutnsudjhttnm f ohthznk pnthth`k `k Fprhc =,

6881 (M`olnt K`. AMF6881U55?>)rno`jjnkmhkg tbn foourftno`jjukhofth`k `a tbn sohnkthaho afot tbftstnfrho fohm m`ns k`t faanot dc``mob`cnstnr`c (bttp9//www.rngucfth`ks.g`v/#!m`olntMntfhc)< (?)Kfdhso`, Hko. sudjhttnm f ohthznkpnthth`k `k Jfy 2, 6887 (M`olnt K`.AMF6887U5=71) rnqunsthkg tbft AMFfjnkm tbn mnahkhth`k `a t`tfc aft fkmsfturftnm aft hk hts a``m cfdnchkgrngucfth`ks t` ocfrhay tbft fontho,pr`ph`kho, fkm dutyrho fohms jfy dnnxocumnm wbnk ofcoucfthkg tbn fj`ukt

`a aft hk f a``m pr`muot (bttp9//www.rngucfth`ks.g`v/#!m`olntMntfhc2) rnqunsthkg tbft AMFnstfdchsb f MQ a`r fmmnm sugfrs fkmrnquhrn tbn fj`ukt `a fmmnm sugfr, fkmtbn pnronkt MQ tbft rnprnsnkts, t` dnmnocfrnm `k a``m cfdncs (bttp9//www.rngucfth`ks.g`v/#!m`olntMntfhc2)< (1)Ur`tnhk ]nobk`c`ghns Hktnrkfth`kfc, Hko.sudjhttnm f ohthznk pnthth`k `kMnonjdnr 46, 4555 (AMF4555U5>18)rnqunsthkg tbft AMF j`mhay tbn

rnanrnkon t` tbn jntb`m usnm t`ofcoucftn pr`tnhk o`ktnkt (bttp9//www.rngucfth`ks.g`v/#!m`olntMntfhc18)< (7)tbn Kfth`kfc _tfrob fkm ObnjhofcO`jpfky (Kfth`kfc _tfrob) sudjhttnmf ohthznk pnthth`k `k Iucy 2, 455=(M`olnt K`. AMF455=U558=)rnqunsthkg tbft mhntfry ahdnr o`ktnkt dnnxocumnm ar`j tbn t`tfc ofrd`bymrftnmnocfrfth`k `k tbn Kutrhth`k Afots cfdnc(bttp9//www.rngucfth`ks.g`v/#!m`olntMntfhc, 455>

(M`olnt K`. AMF455>U5?7?)rnqunsthkg, hk pfrt, tbft AMF fjnkmrngucfth`ks rncftnm t` tbn cfdnchkg `asugfr fkm fctnrkfthvn swnntnknrs (bttp9//www.rngucfth`ks.g`v/#!m`olntMntfhc-U-5?7?)< (8)O_UH sudjhttnm f ohthznk pnthth`k `kK`vnjdnr 2, 455> (M`olnt K`. AMF455>U5681) rnqunsthkg, hk pfrt, tbftAMF c`wnr tbn MQ a`r s`mhuj ar`j4,=55 t` 6,>55 jg/mfy (bttp9//www.rngucfth`ks.g`v/#!m`olntMntfhc-U-5681), 455> (M`olnt K`.

AMF455>U5641) rnqunsthkg tbft AMFprnocumn tbn mnocfrfth`k `a d-ofr`tnkn hksuppcnjnkts fs vhtfjhk F (bttp9//www.rngucfth`ks.g`v/#!m`olntMntfhc-U-5641) grfjs (g) `a trfks aftpnr tfdcnsp``k (bttp9//www.rngucfth`ks.g`v/#!m`olntMntfhc>8), wn rn`pnknm tbno`jjnkt pnrh`m a`r tbn 455? FKUTJ t`rnonhvn o`jjnkts tbft o`kshmnrnm tbnhka`rjfth`k hk tbn H@J Cfdnchkg Tnp`rt(Tna. 4>) pudchsbnm hk tbn hktnrhj tbftfmmrnssnm tbn cfdnchkg `a trfks aft. @kFprhc 68, 455= (18 AT 452?2), wnnxtnkmnm tbn o`jjnkt pnrh`m a`r tbn455? FKUTJ t` rnonhvn o`jjnkts tbfto`kshmnrnm tbn hka`rjfth`k hk tbn 455=jnnthkg `a tbn Kutrhth`k _udo`jjhttnn`a tbn A``m Fmvhs`ry O`jjhttnn (Tna.

QnrMftn Jfr36>;4565 68951 And 42, 456= Ilt 4?4556 U@ 55555 Arj 55565 Ajt =756 _ajt =754 N9SATSAJS5?JTU4._GJ 5?JTU4

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66228Anmnrfc Tnghstnr / Q`c. 78, K`. =6/ J`kmfy, Jfrob ?, 456= / Ur`p`snm Tucns

=1), wbhob fmmrnssnm wbntbnr tbnfvfhcfdcn sohnkthaho nvhmnkon supp`rtnmchsthkg tbn pnronkt MQ a`r sfturftnm aftfkm trfks aft t`gntbnr `r snpfrftncy `ktbn Kutrhth`k Afots cfdnc fkm wbft tbnjfxhjfc mfhcy hktfln `a trfks aft jfy

dn.Hk rnsp`ksn t` tbn 455? FKUTJ, wn

rnonhvnm fd`ut 645 o`jjnkts. Wn

o`kshmnr tbn o`jjnkts rncftnm t`mntnrjhkhkg f MQ a`r trfks aft hk snoth`kHH.D.?. (snn fcs` foo`jpfkyhkg Tna. =7).@tbnr hssuns rfhsnm dy o`jjnkts tbftfrn ukrncftnm t` tbn MQ a`r trfks aft whcc

dn fmmrnssnm hk f snpfrftn rucnjflhkg ftf auturn thjn.

d. FKUTJ `k Ur jhknkon `aOfc`rhnsHk tbn Anmnrfc Tnghstnr `aFprhc =, 455> (75 AT 67552), wnpudchsbnm fk FKUTJ `k tbnpr`jhknkon `a ofc`rhns `k tbn a``m cfdnc(tbn 455> FKUTJ). ]bn 455> FKUTJwfs hssunm hk rnsp`ksn t`rno`jjnkmfth`ks ar`j tbn @dnshty

W`rlhkg Gr`up ornftnm dy tbnO`jjhssh`knr `a A``m fkm Mrugs t`mnvnc`p fk foth`k pcfk t` fmmrnss tbngr`whkg hkohmnkon `a `dnshty hk tbn^khtnm _tftns. ]bn 455> FKUTJ, hkpfrt, rnqunstnm o`jjnkts `k wbntbnrghvhkg j`rn pr`jhknkon t` tbnmnocfrfth`k `a ofc`rhns pnr snrvhkgw`ucm hkornfsn o`ksujnr fwfrnknss `atbn ofc`rho o`ktnkt `a tbn pfolfgnm a``m.Wn fcs` s`ugbt o`jjnkt `k wbntbnrpr`vhmhkg f pnronkt MQ a`r t`tfc ofc`rhnsw`ucm bncp o`ksujnrs ukmnrstfkm tbnofc`rho o`ktnkt `a tbn pfolfgnm a``m hktbn o`ktnxt `a f 4,555 ofc`rhn mhnt. Hk

fmmhth`k, wn fcs` rnqunstnm o`jjnkts`k qunsth`ks o`konrkhkg tbn mnocfrfth`k`a Ofc`rhns ar`j aft (75 AT 67552 ft67565).

Wn rnonhvnm fd`ut =55 o`jjnkts t`tbn 455> FKUTJ, nfob o`ktfhkhkg `kn`r j`rn hssuns, ar`j hkmustry, trfmnfss`ohfth`ks, o`ksujnr gr`ups,hkmhvhmufc o`ksujnrs, g`vnrkjnkt, fkmfofmnjhf. Wn o`kshmnr tbn o`jjnkts hksnoth`ks HH.F. fkm HH.J. (snn fcs`foo`jpfkyhkg Tna. =7).

o. FKUTJ `k A``m Cfdnchkg9 Tnvhsh`k`a Tnanrnkon Qfcuns fkm Jfkmft`ryKutrhnktsHk tbn Anmnrfc Tnghstnr `a

K`vnjdnr 4, 4557 (74 AT 146=8), wnpudchsbnm fk FKUTJ rngfrmhkg tbnrnvhsh`k `a rnanrnkon vfcuns fkmjfkmft`ry kutrhnkts (tbn 4557 FKUTJ).]bn 4557 FKUTJ rnqunstnm o`jjnkt`k vfrh`us fspnots `a kutrhth`k cfdnchkg,hkocumhkg wbft knw rnanrnkon vfcuns wnsb`ucm usn t` ofcoucftn tbn pnronkt MQhk tbn Kutrhth`k Afots fkm _uppcnjnktAfots cfdncs fkm wbft afot`rs wn sb`ucmo`kshmnr hk nstfdchsbhkg suob knwrnanrnkon vfcuns. Hk fmmhth`k, wnrnqunstnm o`jjnkts `k wbntbnr wnsb`ucm rnquhrn tbft onrtfhk kutrhnkts dn

fmmnm `r rnj`vnm ar`j tbn Kutrhth`kAfots fkm _uppcnjnkt Afots cfdncs.

Hk rnsp`ksn t` tbn 4557 FKUTJ, wnrnonhvnm fd`ut 245 o`jjnkts, ar`jhkmustry, trfmn fss`ohfth`ks, o`ksujnrgr`ups, hkmhvhmufc o`ksujnrs,g`vnrkjnkt, fkm fofmnjhf. Wn o`kshmnrtbnsn o`jjnkts hk nfob `a tbn rncnvfkthkmhvhmufc kutrhnkt snoth`ks hk tbhs

m`oujnkt (snn fcs` foo`jpfkyhkg Tna.=7).

7. Hjpfot `k @tbnr Tngucfth`ks

Wn rno`gkhzn tbft obfkgns t` tbn chst`a kutrhnkts mnocfrnm `k tbn Kutrhth`kAfots cfdnc `r tbn TMHs `r MTQs `akutrhnkts whcc chlncy faanot `tbnr AMFrngucfth`ks, hkocumhkg onrtfhk cfdnchkgrnquhrnjnkts a`r a``ms hk 46 OAT pfrt656. A`r nxfjpcn, tbn MQs frn usnm t`mntnrjhkn, hk pfrt, wbntbnr f a``m `rmhntfry suppcnjnkt hs nchghdcn t` dnfrkutrhnkt o`ktnkt ocfhjs `r bnfctb ocfhjs(snn a`r nxfjpcn 656.6=, 656.>=,656.71, 656.72, fkm 656.78). Hk fmmhth`k,`ur a`rthahofth`k p`choy rnanrs t` TMHsfkm onrtfhk MTQs tbft frn spnohahnm hk 656.8 hk mnsorhdhkg prhkohpcns a`r tbnrfth`kfc fmmhth`k `a kutrhnkts t` a``ms( 65=.45 (46 OAT 65=.45)). Wn pcfk t`nvfcuftn tbn hjpfot `a tbn pr`p`snmobfkgns t` tbn Kutrhth`k Afots fkm_uppcnjnkt Afots cfdncs, ha ahkfchznm, `k`tbnr AMF rngucfth`ks. Wn hktnkm t`fmmrnss, fs fppr`prhftn, tbn hjpfot `k`tbnr AMF rngucfth`ks hk auturn snpfrftnrucnjflhkgs. ]bus, hssuns rncftnm t`kutrhnkt o`ktnkt ocfhjs fkm bnfctbocfhjs frn `utshmn tbn so`pn `a tbhsrucnjflhkg.

O. Afot`rs a`r Jfkmft`ry `r Q`cuktfryMnocfrfth`k `a K`k-_tftut`ry Kutrhnkts

^kmnr snoth`k =5?(q)(6)(O) fkm (M) `atbn AM&O Fot, kutrhth`k hka`rjfth`k hka``m cfdnchkg just hkocumn tbn t`tfckujdnr `a ofc`rhns, mnrhvnm ar`j fkys`uron fkm mnrhvnm ar`j tbn t`tfc aft,fkm tbn fj`ukts `a t`tfc aft, sfturftnmaft, ob`cnstnr`c, s`mhuj, t`tfcofrd`bymrftns, o`jpcnx ofrd`bymrftns,sugfrs, mhntfry ahdnr, fkm t`tfc pr`tnhk.A`r purp`sns `a tbhs pr`p`snm rucn, wno`kshmnr tbn kutrhnkts tbft frn nxpchohtcyrnquhrnm dy tbn AM&O Fot t` dn mnocfrnm

`k tbn Kutrhth`k Afots cfdnc fsstftut`rhcy rnquhrnm kutrhnkts. _noth`k=5?(q)(4)(D) `a tbn AM&O Fot pnrjhts tbn_norntfry, fkm dy mncngfth`k, AMF, t`rnj`vn f stftut`rhcy rnquhrnm kutrhnktsar`j tbn cfdnc `r cfdnchkg `a a``m, dyrngucfth`k, ha tbn _norntfry mntnrjhknstbn hka`rjfth`k rncftnm t` tbft kutrhnkths k`t knonssfry t` fsshst o`ksujnrs hkjfhktfhkhkg bnfctby mhntfry prfothons.AMF rngucfth`ks rnquhrn tbn mnocfrfth`k`a tbn a`cc`whkg stftut`rhcy rnquhrnmkutrhnkts9 ]`tfc ofc`rhns, ofc`rhns ar`jaft, t`tfc aft, sfturftnm aft, ob`cnstnr`c,

s`mhuj, t`tfc ofrd`bymrftns, sugfrs,mhntfry ahdnr, fkm t`tfc pr`tnhk (_nn Tna.6 a`r hka`rjfth`k `k rngucft`ry bhst`ry).Fs pfrt `a tbn naa`rt t` upmftn tbnKutrhth`k Afots cfdnc, wn rno`kshmnrnmtbn mnocfrfth`k `a tbnsn stftut`rhcyrnquhrnm kutrhnkts. @ur o`kshmnrfth`ksfkm tnktfthvn o`kocush`ks `k tbnsnkutrhnkts frn prnsnktnm whtbhk tbn

mhsoussh`k `a hkmhvhmufc kutrhnkts hksnoth`k HH.

_noth`k =5?(q)(4)(F) `a tbn AM&O Fotpr`vhmns tbft tbn _norntfry (fkm dymncngfth`k AMF) jfy, dy rngucfth`k,rnquhrn `tbnr kutrhnkts t` dn mnocfrnm hatbn _norntfry mntnrjhkns tbft f kutrhnktwhcc pr`vhmn hka`rjfth`k rngfrmhkg tbnkutrhth`kfc vfcun `a suob a``m tbft whccfsshst o`ksujnrs hk jfhktfhkhkg bnfctbymhntfry prfothons. A`r purp`sns `a tbhspr`p`snm rucn, wn o`kshmnr suobkutrhnkts tbft frn k`t stftut`rhcyrnquhrnm dut sudinot t` `ur mhsornth`kukmnr snoth`k =5?(q)(4)(F) `a tbn AM&O

Fot, fs k`k-stftut`ry kutrhnkts t`mhsthkguhsb suob kutrhnkts ar`j tb`snnxprnsscy rnquhrnm dy tbn stftutn. Hk tbn688? kutrhnkt o`ktnkt ahkfc rucn (>2 AT4578), wn o`kshmnrnm tbn nxhstnkon `a fqufkthtfthvn hktfln rno`jjnkmfth`kbhgbchgbtnm hk ^._. o`ksnksus rnp`rtsfkm tbn pudcho bnfctb shgkhahofkon `a tbnkutrhnkt hk nxnrohshkg `ur mhsornth`k t`mntnrjhkn wbhob k`k-stftut`rykutrhnkts t` rnquhrn `r pnrjht `k tbnKutrhth`k Afots cfdnc. Dfsnm `k tbnsno`kshmnrfth`ks, whtb rnspnot t` k`k-stftut`ry kutrhnkts, wn (6) rnquhrnm tbnmnocfrfth`k `a onrtfhk nssnkthfc vhtfjhksfkm jhknrfcs a`r wbhob fk TMH wfs

nstfdchsbnm fkm tbft wnrn mntnrjhknm t`bfvn pudcho bnfctb shgkhahofkon (h.n.,vhtfjhks F fkm O, hr`k, fkm ofcohuj)2 AT 4578).

Hk tbhs snoth`k, wn mnsorhdn `urourrnkt tbhklhkg rncftnm t`o`kshmnrfth`ks usnm t` mntnrjhknwbntbnr f k`k-stftut`ry kutrhnkt sb`ucm

dn rnquhrnm `r pnrjhttnm t` dn mnocfrnm`k tbn Kutrhth`k Afots cfdnc. Fppcyhkgtbhs ourrnkt tbhklhkg, hk snoth`k HH, wnfrn pr`p`shkg tbn jfkmft`ry mnocfrfth`k`a onrtfhk k`k-stftut`ry kutrhnkts,v`cuktfry mnocfrfth`k `a `tbnrs, fkmpr`p`shkg t` rnj`vn tbn jfkmft`rymnocfrfth`k `a fk`tbnr kutrhnkt. A`rpurp`sns `a tbhs pr`p`snm rucn, wn usntbn tnrj kutrhnkt t` rnanr t`

QnrMftn Jfr36>;4565 68951 And 42, 456= Ilt 4?4556 U@ 55555 Arj 55566 Ajt =756 _ajt =754 N9SATSAJS5?JTU4._GJ 5?JTU4

8/12/2019 FDA-2012-N-1210-0002

12/109

66285 Anmnrfc Tnghstnr / Q`c. 78, K`. =6/ J`kmfy, Jfrob ?, 456= / Ur`p`snm Tucns

sudstfkons tbft frn ourrnktcy hkocumnm`r tbft wn frn o`kshmnrhkg a`r hkocush`k`k tbn Kutrhth`k Afots cfdnc, hkocumhkgofrd`bymrftn, aft, fkm pr`tnhk fkm tbnhrsudo`jp`knkts (n.g., fmmnm sugfrs,sugfr fco`b`cs, sfturftnm aft),jhor`kutrhnkts (vhtfjhks fkm jhknrfcs),fkm t` ofc`rhns, hkocumhkg ofc`rhns ar`jaft.

6. Afot`rs O`kshmnrnm

Wn upmftnm tbn hka`rjfth`k tbft wno`kshmnr a`r mntnrjhkhkg wbntbnr tbnmnocfrfth`k `a f k`k-stftut`ry kutrhnktsb`ucm dn jfkmft`ry `r v`cuktfry. ]bhsupmftn rnsp`kms t` snvnrfcmnvnc`pjnkts. _hkon tbn 688? kutrhnkto`ktnkt ahkfc rucn wfs pudchsbnm, (6)knw sohnkthaho mftf bfvn pr`vhmnmfmmhth`kfc nvhmnkon `a tbn r`cn `a onrtfhkkutrhnkts hk obr`kho mhsnfsn rhsl, bnfctb-rncftnm o`kmhth`ks, `r bnfctb-rncftnmpbysh`c`ghofc nkmp`hkts fkm, hk s`jnofsns, dfsnm `k tbn rnvhnw `a tbhsnvhmnkon, MTHs frn k`w fvfhcfdcn ar`jtbn H@J tbft ofk dn usnm fs qufkthtfthvnhktfln rno`jjnkmfth`ks (h.n., TMF fkmFH), fs wncc fs a`r fssnsshkg tbnhkfmnqufoy fkm fmnqufoy `a nssnkthfcvhtfjhks fkm jhknrfcs hk tbn ^._.p`pucfth`k (h.n., NFT fkm FH)< (4) tbnrftns `a onrtfhk mhsnfsns `r bnfctb-rncftnm o`kmhth`ks bfvn nhtbnr obfkgnm`r rnjfhknm bhgb< fkm (?) tbn pr`onss a`rnvfcufthkg tbn rncfth`ksbhp dntwnnk fkutrhnkt fkm obr`kho mhsnfsn rhsl, fbnfctb-rncftnm o`kmhth`k, `r f bnfctb-rncftnm pbysh`c`ghofc nkmp`hkt bfs dnnkrnahknm dfsnm `k tbn usn `a systnjfthonvhmnkon-dfsnm rnvhnws a`r f kujdnr `a

kutrhnkts (n.g., 4565 MGF, AMF bnfctbocfhjs).

Wn o`kthkun t` dn jhkmauc `a pfstafot`rs wn o`kshmnrnm fs pfrt `a `urmnchdnrfth`ks rncftnm t` tbn Kutrhth`kAfots cfdnc, suob fs tbn kujdnr `akutrhnkts tbft o`ucm dn chstnm hkkutrhth`k cfdnchkg, tbft s`jn hkmhvhmufcso`ucm hktnrprnt f c`kg chst `a kutrhnkts fshjpcyhkg tbft f a``m bfs grnftnrkutrhth`kfc shgkhahofkon tbfk hs tbn ofsn,fkm tbft tbnrn hs chjhtnm spfon a`rkutrhth`k hka`rjfth`k `k tbn cfdnc (>>AT 48=27 ft 48=8?< Iucy 68 6885).

]` bncp us mntnrjhkn wbntbnr f k`k-

stftut`ry kutrhnkt sb`ucm dn f rnquhrnm`r pnrjhttnm mnocfrfth`k, wn frno`kshmnrhkg tbn sfjn gnknrfc typns `ahka`rjfth`k usnm hk 688? wbnk tbnkutrhnkt o`ktnkt ahkfc rucn wfspudchsbnm9 (6) Nxhstnkon `a qufkthtfthvnhktfln rno`jjnkmfth`ks< fkm (4) pudchobnfctb shgkhahofkon. Wn mhsouss nfob `atbnsn afot`rs hk grnftnr mntfhc hk tbhsm`oujnkt.

f. Vufkthtfthvn HktflnTno`jjnkmfth`ksVufkthtfthvn hktflnrno`jjnkmfth`ks frn rnanrnkon hktflncnvncs pr`vhmnm hk o`ksnksus rnp`rts

tbft ofk dn usnm t` snt f MTQ `r TMH.Wn nxpnot tbnsn o`ksnksus rnp`rts t` dnpudchsbnm a`r tbn purp`sn `a sntthkgqufkthtfthvn hktfln rno`jjnkmfth`ks(n.g., tbn H@J MTH rnp`rts). Ha MTHs frnk`t fvfhcfdcn a`r kutrhnkts, `tbnr tbfknssnkthfc vhtfjhks fkm jhknrfcs, tbnkwn o`kshmnr sohnkon-dfsnmrno`jjnkmfth`ks ar`j `tbnr ^._.

o`ksnksus rnp`rts `r tbn MGF p`choyrnp`rts. _uob rno`jjnkmfth`ks jfy dnhmnkthahnm fs f o`kocush`k, lnyrno`jjnkmfth`k, `r rnp`rtnm hk tbnnxnouthvn sujjfry `a tbn o`ksnksusrnp`rt.

d. Uudcho Bnfctb _hgkhahofkonA`r tbnpurp`sns `a kutrhth`k cfdnchkg `a a``msfkm mhntfry suppcnjnkts, wn o`kshmnrpudcho bnfctb shgkhahofkon t` rnanr t` tw`ncnjnkts. Ahrst wn o`kshmnr wbntbnrtbnrn hs nvhmnkon `a f rncfth`ksbhp

dntwnnk tbn kutrhnkt fkm f obr`khomhsnfsn, bnfctb-rncftnm o`kmhth`k, `rbnfctb-rncftnm pbysh`c`ghofc nkmp`hkt.

]bhs ofk dn mnj`kstrftnm nhtbnr dywncc-nstfdchsbnm nvhmnkon `r, a`rnssnkthfc vhtfjhks fkm jhknrfcs,rno`jjnkmfth`ks rngfrmhkg tbn bnfctbo`ksnqunkons `a hkfmnqufoy `a tbnkutrhnkt. _no`km wn o`kshmnr wbntbnrtbnrn hs nvhmnkon `a f pr`dcnj rncftnm t`bnfctb hk tbn gnknrfc ^._. p`pucfth`k.]bhs knnms t` dn mnj`kstrftnm dy d`tbnvhmnkon `a f pr`dcnj whtb tbn hktfln`a tbn kutrhnkt hk tbn gnknrfc ^._.p`pucfth`k fkm nvhmnkon `a tbnprnvfcnkon `a tbn obr`kho mhsnfsn,bnfctb-rncftnm o`kmhth`k, `r bnfctb-rncftnm pbysh`c`ghofc nkmp`hkt tbft hs

chklnm t` tbft kutrhnkt hk tbn gnknrfc^._. p`pucfth`k. Wn o`kshmnr pudchobnfctb shgkhahofkon t` rnanr t` tbna`cc`whkg9 (6) Nxhstnkon `a wncc-nstfdchsbnm sohnkthaho nvhmnkon ar`j^._. o`ksnksus rnp`rts tbft tbnrn hs frncfth`ksbhp dntwnnk f kutrhnkt fkmobr`kho mhsnfsn rhsl, f bnfctb-rncftnmo`kmhth`k, `r f bnfctb-rncftnmpbysh`c`ghofc nkmp`hkt fkm wbnrn tbnhktfln `a suob kutrhnkt hs `a gnknrfchjp`rtfkon hk tbn gnknrfc ^._.p`pucfth`k, n.g., wbnrn hktflns frngnknrfccy t`` c`w `r t`` bhgb fj`kg tbn^._. p`pucfth`k. ._. o`ksnksus rnp`rts

frn tb`sn rnp`rts tbft pr`vhmn o`ksnksuso`kocush`ks `r rno`jjnkmfth`ks dy fgr`up `a nxpnrts fs rnqunstnm dy ^._.G`vnrkjnkt Fgnkohns (n.g., H@J rnp`rts,tbn MGFs, Kfth`kfc Hksthtutns `a Bnfctb(KHB) o`ksnksus rnp`rts). Wn gnknrfccyo`kshmnr sohnkthaho nvhmnkon t` dn wncc-nstfdchsbnm wbnk suob o`ksnksusrnp`rts bfvn mntnrjhknm tbn nvhmnkon t`

dn o`kocushvn, m`oujnktnm, `rstr`kg. Nvhmnkon tbft jnnts tbnshgkhahofkt sohnkthaho fgrnnjnkt stfkmfrmhk snoth`k =5?(r)(?)(D)(h) `a tbn AM&OFot hk supp`rt `a tb`sn kutrhnkts fkm

mhsnfsn `r bnfctb-rncftnm o`kmhth`ks a`rwbhob wn bfvn futb`rhznm f bnfctbocfhj w`ucm dn o`kshmnrnm wncc-nstfdchsbnm nvhmnkon a`r tbn purp`sns`a wbft pudcho bnfctb shgkhahofkon rnanrst` hk tbhs pr`p`snm rucn< `r (4) kutrhnktsa`r wbhob tbnrn frn MTHs snt dy tbn H@J(h.n., TMF `r FH) tbft frn dfsnm `kobr`kho mhsnfsn rhsl (n.g., `stn`p`r`shs),

f bnfctb-rncftnm o`kmhth`k (n.g., dc``mprnssurn) `r f kutrhnkt mnahohnkoy whtbochkhofc shgkhahofkon (n.g., c`w hr`kst`rfgn cnfmhkg t` hr`k mnahohnkoyfknjhf) a`r wbhob hkfmnquftn hktflns `atbnsn kutrhnkts frn chlncy t` bfvnhjp`rtfkt ochkhofc o`ksnqunkons. ]bnkutrhnkts a`r wbhob tbhs jfy `oour frnnssnkthfc vhtfjhks fkm jhknrfcs< fkm (?)a`r fcc kutrhnkts, tbnrn hs nvhmnkon `ahkfmnquftn `r nxonss hktfln `a tbnkutrhnkt dfsnm `k kfth`kfc kutrhth`kfcsurvny mftf `r ^._. o`ksnksus rnp`rts,fkm tbft f sudstfkthfc prnvfcnkon nxhstshk tbn gnknrfc ^._. p`pucfth`k `a tbn

obr`kho mhsnfsn, bnfctb-rncftnmo`kmhth`k, `r bnfctb-rncftnmpbysh`c`ghofc nkmp`hkt tbft wfs chklnmt` tbn pfrthoucfr kutrhnkt (n.g., s`cudcnahdnr fkm o`r`kfry bnfrt mhsnfsn (OBM)rhsl, ofcohuj fkm rhsl `a `stn`p`r`shs).Dnofusn wn rnjfhk o`konrknm fd`ut tbncfrgn kujdnr `a kutrhnkts tbft o`ucm dnchstnm fs jfkmft`ry `r v`cuktfry, a`rnssnkthfc vhtfjhks fkm jhknrfcs, wn frnpr`p`shkg a`r jfkmft`ry mnocfrfth`k,tb`sn a`r wbhob hkfmnqufoy bfs tbngrnftnst hjpfot `k pudcho bnfctb dnofusn`a tbnhr fss`ohfth`k whtb f rhsl `aobr`kho mhsnfsn, f bnfctb-rncftnm

o`kmhth`k, `r f kutrhnkt mnahohnkoy whtbochkhofc shgkhahofkon (n.g., hr`kmnahohnkoy fknjhf).

]bn jntb`ms usnm hk tbn nvfcufth`k `apudcho bnfctb shgkhahofkon `a nssnkthfcvhtfjhks fkm jhknrfcs frn mhsoussnm hkgrnftnr mntfhc hk snoth`k HH.B. fkm tbnfoo`jpfkyhkg rnanrnkon m`oujnkt (Tna.=2).

4. Fppr`fob a`r Jfkmft`ry Mnocfrfth`k

Hk gnknrfc, wn o`kthkun t` o`kshmnrjfkmft`ry mnocfrfth`k fppr`prhftnwbnk tbnrn hs pudcho bnfctb shgkhahofkonfkm f qufkthtfthvn hktfln

rno`jjnkmfth`k tbft ofk dn usnm a`rsntthkg f MQ (MTQ `r TMH). B`wnvnr, wnbfvn fcs` o`kshmnrnm jfkmft`rymnocfrfth`k dfsnm, hk pfrt, `k nvhmnkonbhgbchgbthkg tbn r`cn `a f kutrhnkt hkobr`kho mhsnfsn rhsl. A`r nxfjpcn, hk455?, wn pudchsbnm f ahkfc rucnrnquhrhkg trfks aft mnocfrfth`k `k tbnKutrhth`k Afots cfdnc (12 AT =6=?=). Wno`kshmnrnm mftf fkm hka`rjfth`k rncftnmt` tbn rhsl `a o`r`kfry bnfrt mhsnfsnar`j o`ksujpth`k `a trfks aft. Hkfmmhth`k, wn o`kshmnrnm tbn pudchobnfctb shgkhahofkon `a trfks aft hktfln

QnrMftn Jfr36>;4565 68951 And 42, 456= Ilt 4?4556 U@ 55555 Arj 55564 Ajt =756 _ajt =754 N9SATSAJS5?JTU4._GJ 5?JTU4

8/12/2019 FDA-2012-N-1210-0002

13/109

66286Anmnrfc Tnghstnr / Q`c. 78, K`. =6/ J`kmfy, Jfrob ?, 456= / Ur`p`snm Tucns

dfsnm `k o`ksnksus rnp`rts fkm anmnrfcp`choy stftnjnkts.

Hka`rjfth`k rncftnm t` kutrhnkt hktflnfkm hts naanot `k bnfctb hs k`t stftho.Tno`jjnkmfth`ks ar`j vfrh`ussohnkthaho d`mhns `a tbn ^._. G`vnrkjnkttbft frn rnsp`kshdcn a`r pudcho bnfctbpr`tnoth`k `r rnsnfrob mhrnotcy rncfthkgt` bujfk kutrhth`k jfy obfkgn `r

nv`cvn `vnr thjn. Wn hkocumn, fs pfrt `a`ur rnvhnw `a kutrhnkt hka`rjfth`k hktbhs pr`p`snm rucn, tbn ourrnktrno`jjnkmfth`ks ar`j suob sohnkthaho

d`mhns. Hk snoth`k M.?, wn spnohahofccyo`kshmnr rno`jjnkmfth`ks ar`j tbn4565 MGF rncftnm t` tbn hktfln `a fmmnmsugfrs hk tbn mhnt fkm tbn r`cn `a suobhka`rjfth`k hk fsshsthkg o`ksujnrs t`jfhktfhk bnfctby mhntfry prfothons. @urrnvhnw hs k`t dfsnm `k tbn afot`rs wnbfvn trfmhth`kfccy o`kshmnrnm a`rjfkmft`ry mnocfrfth`k tbft frn rncftnmt` obr`kho mhsnfsn, bnfctb-rncftnmo`kmhth`k, `r bnfctb-rncftnm

pbysh`c`ghofc nkmp`hkt chklnm t` tbnpfrthoucfr kutrhnkt. Hkstnfm, `ur rnvhnwhs dfsnm `k tbn knnm a`r kutrhnkthka`rjfth`k a`r o`ksujnrs t` hjpcnjnktlny mhntfry rno`jjnkmfth`ks t` fsshsto`ksujnrs t` jfhktfhk bnfctby mhntfryprfothons fkm tbn knnm a`r o`ksujnrs t`

dn fdcn t` rnfmhcy `dsnrvn fkmo`jprnbnkm tbn hka`rjfth`k fkm t`ukmnrstfkm hts rncfthvn shgkhahofkon hktbn o`ktnxt `a f t`tfc mfhcy mhnt.

?. Fppr`fob a`r Q`cuktfry Mnocfrfth`k

A`r kutrhnkts tbft frn k`t nssnkthfcvhtfjhks fkm jhknrfcs (n.g., acu`rhmn,s`cudcn fkm hks`cudcn ahdnr,

j`k`uksfturftnm aftty fohms fkmp`cyuksfturftnm aftty fohms), wno`kshmnr v`cuktfry mnocfrfth`k t` dnfppr`prhftn wbnk tbn kutrhnkt nhtbnr bfsf qufkthtfthvn hktfln rno`jjnkmfth`k

dut m`ns k`t bfvn pudcho bnfctbshgkhahofkon, `r m`ns k`t bfvn fqufkthtfthvn hktfln rno`jjnkmfth`kfvfhcfdcn a`r sntthkg f MTQ dut bfspudcho bnfctb shgkhahofkon. Hk fmmhth`k,wn o`kshmnr tbft v`cuktfry mnocfrfth`ksb`ucm dn pnrjhttnm a`r nssnkthfcvhtfjhks `r jhknrfcs tbft wn mntnrjhknm` k`t aht whtbhk `ur o`kshmnrfth`ks a`rjfkmft`ry mnocfrfth`k, dut tbft bfvn fk

TMH.Wn hkvhtn o`jjnkt `k tbn afot`rs a`ro`kshmnrhkg jfkmft`ry fkm v`cuktfrymnocfrfth`k `a k`k-stftut`ry kutrhnkts.

HH. ]bn Ur`p`snm Tucn

Hk tbhs pr`p`snm rucn, wn fmmrnsshssuns rncftnm t` tbn hka`rjfth`kmnocfrnm `k tbn Kutrhth`k Afots cfdnc,h.n., mnocfrfth`k `a kutrhnkts, mnahkhth`ks,fkfcythofc jntb`ms, TMHs fkm MTQs,a`rjft, fkm o`jpchfkon whtb mnocfrnmvfcuns. _noth`ks HH.F. tbr`ugb HH.N.mhsouss hssuns rncftnm t` ofc`rhns fkm

jfor`kutrhnkts (hkocumhkg aft, afttyfohms, ob`cnstnr`c, ofrd`bymrftns,sugfrs, ahdnr, fkm pr`tnhk), wbnrnfssnoth`ks HH.A. tbr`ugb HH.I. mhsouss hssunsrncftnm t` vhtfjhks fkm jhknrfcs, fkmsnoth`ks HH.L. fkm HH.C. mhsouss kutrhth`kcfdnchkg rnquhrnjnkts fppchofdcn t`onrtfhk p`pucfth`k sudgr`ups fkmmhntfry suppcnjnkts, rnspnothvncy.

_noth`k HH.J. o`vnrs hssuns rncftnm t` tbna`rjft `a tbn Kutrhth`k Afots cfdnc,a`cc`wnm dy snoth`k HH.K., wbhob a`ousns`k pr`vhsh`ks rncftnm t` o`jpchfkon fkmvnrhahofth`k. Ahkfccy, snoth`k HH.@.mnsorhdns tnobkhofc fjnkmjnkts t`nxhsthkg pr`vhsh`ks hk 656.8.

Fs mhsoussnm hk tbhs m`oujnkt, `urnvfcufth`k `a tbnsn hssuns wfs hka`rjnm

dy ourrnkt sohnkthaho nvhmnkon, mhntfryrno`jjnkmfth`ks, fkm o`kocush`ks `aourrnkt o`ksnksus rnp`rts. Wn t``l hkt`foo`ukt fky rncftnm rnqunsts ar`jpnthth`knrs fkm pudcho o`jjnkts.

F. Ofc`rhns

_noth`k =5?(q)(6)(O) `a tbn AM&O Fotrnquhrns tbn mnocfrfth`k `a tbn t`tfckujdnr `a ofc`rhns mnrhvnm ar`j fkys`uron. O`rrnsp`kmhkgcy, AMFrngucfth`ks rnquhrn tbn t`tfc ofc`rhoo`ktnkt `a f a``m t` dn mnocfrnm `k tbnKutrhth`k Afots cfdnc ( 656.8(o)(6)). Wnfrn k`t pr`p`shkg t` j`mhay tbnrnquhrnjnkt t` mnocfrn t`tfc ofc`rhns.B`wnvnr, wn frn rno`kshmnrhkg fkujdnr `a `tbnr rnquhrnjnkts rncftnm t`tbn mnocfrfth`k `a hka`rjfth`k fd`utofc`rhns. ]bn rnquhrnjnkts rncftnm t`Ofc`rhns ar`j aft, Ofc`rhns ar`jsfturftnm aft, tbn 4,555 rnanrnkon

ofc`rhn hktfln cnvnc, fkm f pnronkt MQa`r ofc`rhns frn mhsoussnm hk snoth`kHH.F., wbnrnfs rnquhrnjnkts rncftnm t`pr`jhknkon `a tbn ofc`rhn mnocfrfth`kfkm tbn a``tk`tn stftnjnkt fkm tfdcn `aMQs a`r 4,555 fkm 4,>55 ofc`rhn mhnts frnmhsoussnm hk snoth`k HH.J.

6. Ofc`rhns Ar`j Aft

]bn mnocfrfth`k `a Ofc`rhns ar`j afths jfkmft`ry ( 656.8(o)(6)(hh)). _noth`k=5?(q)(6)(O)(hh) `a tbn AM&O Fot rnquhrnst`tfc ofc`rhns ar`j aft t` dn mnocfrnm `ktbn cfdnc `r cfdnchkg `a a``m. _noth`k=5?(q)(4)(D) `a tbn AM&O Fot pr`vhmns

tbn _norntfry `a Bnfctb fkm Bujfk_nrvhons (fkm dy mncngfth`k, AMF) whtbmhsornth`k t` rnj`vn tbn rnquhrnjnkt dyrngucfth`k ha tbn _norntfry mntnrjhknstbft ht hs k`t knonssfry t` fsshsto`ksujnrs hk jfhktfhkhkg bnfctbymhntfry prfothons. Wn rnvhnwnm ourrnktsohnkthaho nvhmnkon fkmrno`jjnkmfth`ks hk ourrnkt o`ksnksusrnp`rts hk mntnrjhkhkg wbntbnrhka`rjfth`k `k ofc`rhns ar`j aft hsknonssfry t` fsshst o`ksujnrs hkjfhktfhkhkg bnfctby mhntfry prfothons.Wn fcs` o`kshmnrnm o`jjnkts (Tna. =7)

t` tbn 455> fkm 4557 FKUTJs, hkwbhob wn rnqunstnm o`jjnkt `kvfrh`us qunsth`ks rncftnm t` Ofc`rhnsar`j aft mnocfrnm `k tbn Kutrhth`kAfots cfdnc. ^kchln mhntfryrno`jjnkmfth`ks tbft wn rnchnm `kmurhkg tbn 688? rucnjflhkg, ourrnktmhntfry rno`jjnkmfth`ks k` c`kgnrnjpbfshzn t`tfc aft. Onrtfhk aftty fohmsfrn ukmnrst``m t` dn dnknahohfc, wbhcn`tbnrs frn ukmnrst``m t` bfvn kngfthvnbnfctb naanots, pfrthoucfrcy rncftnm t`ofrmh`vfsoucfr mhsnfsn (Tnas. 1, ?1, fkm=8). Foo`rmhkgcy, tbn 455> MGF sbhatnmhts a`ous ar`j t`tfc aft rnmuoth`k t`rnmuoth`k hk onrtfhk typns `a aftty fohmsfkm tbnhr hkacunkon `k tbn rhsl `aofrmh`vfsoucfr mhsnfsn (Tna. ?1). ]bn4554 H@J Jfor`kutrhnkt Tnp`rt (Tna.=8) snt fk FJMT a`r t`tfc aft ft 45 t`?> pnronkt `a ofc`rhns, rno`gkhzhkg tbfttbnrn wnrn s`jn dnknahts t` o`ksujhkgj`mnrftn fj`ukts `a aft (Tna. =8). ]bn

4554 H@J Jfor`kutrhnkt Tnp`rt fkm tbn4565 MGF (Tnas. 1 fkm =8) o`kocumnmtbft tbn typn `a aft o`ksujnm wfs j`rnrncnvfkt hk rnmuohkg tbn rhsl `a OBMtbfk `vnrfcc t`tfc aft hktfln.

Dfsnm `k tbn tbnsn mhntfryrno`jjnkmfth`ks fkm o`ksnksusrnp`rts tbft njpbfshzn hktfln `a t`tfcofc`rhns fkm tbn typn `a aft o`ksujnm,fs wncc fs o`jjnkts t` tbn 455> fkm4557 FKUTJs tbft supp`rtnmnchjhkfthkg tbn mnocfrfth`k `a Ofc`rhnsar`j aft hk `rmnr t` pcfon grnftnrnjpbfshs `k t`tfc ofc`rhns (Tna. =7), wntnktfthvncy o`kocumn tbft mnocfrfth`k `a

Ofc`rhns ar`j aft hs k`t knonssfry t`fsshst o`ksujnrs hk jfhktfhkhkg bnfctbymhntfry prfothons. ]bnrna`rn, wn frnpr`p`shkg t` k` c`kgnr rnquhrn, fkm t`k`t fcc`w v`cuktfrhcy, tbn mnocfrfth`k `aOfc`rhns ar`j aft `k tbn Kutrhth`kAfots cfdnc. Wbhcn nchjhkfthkg tbnmnocfrfth`k `a Ofc`rhns ar`j aft jfyfppnfr t` dn f c`ss `a hka`rjfth`k `k tbnfj`ukt `a aft dnhkg o`ksujnm, fs s`jno`jjnkts suggnstnm, tbn fj`ukt `a aft

dnhkg o`ksujnm ofk sthcc dn `dtfhknmar`j tbn t`tfc aft mnocfrfth`k ncsnwbnrn`k tbn Kutrhth`k Afots cfdnc, fkmo`ksujnrs ofk sthcc usn tbn pnronkt MQ

a`r t`tfc aft t` put aft o`ktnkt hk tbno`ktnxt `a f t`tfc mfhcy mhnt, o`jpfrnpr`muots, fkm pcfk mhnts. ]bnrna`rn, wnfrn pr`p`shkg t` rnj`vn ourrnkt 656.8(o)(6)(hh) t` rnj`vn tbnrnquhrnjnkt a`r mnocfrfth`k `a ofc`rhnsar`j aft (fkm rnmnshgkftn 656.8(o)(6)(hhh) fs pr`p`snm 656.8(o)(6)(hh)). Wn hkvhtn o`jjnkt `ktbn tnktfthvn o`kocush`k t` k` c`kgnrrnquhrn, fkm t` k`t fcc`w v`cuktfrhcy tbnmnocfrfth`k `a Ofc`rhns ar`j aft `k tbnKutrhth`k Afots cfdnc.

QnrMftn Jfr36>;4565 68951 And 42, 456= Ilt 4?4556 U@ 55555 Arj 5556? Ajt =756 _ajt =754 N9SATSAJS5?JTU4._GJ 5?JTU4

8/12/2019 FDA-2012-N-1210-0002

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66284 Anmnrfc Tnghstnr / Q`c. 78, K`. =6/ J`kmfy, Jfrob ?, 456= / Ur`p`snm Tucns

4. Ofc`rhns Ar`j _fturftnm Aft

]bn mnocfrfth`k `a Ofc`rhns ar`jsfturftnm aft hs v`cuktfry( 656.8(o)(6)(hhh)). ]bn 4565 MGFo`kthkuns t` rno`jjnkm tbft Fjnrhofkssb`ucm o`ksujn cnss tbfk 65 pnronkt `aofc`rhns ar`j sfturftnm aft (Tna. 1)._fturftnm aft hs lk`wk t` hkornfsn tbn

rhsl `a ofrmh`vfsoucfr mhsnfsn fkm,ukchln Ofc`rhns ar`j aft, wbhob o`ucmhkocumn ofc`rhns fttrhdutfdcn t` afttyfohms tbft mnornfsn `r hkornfsn tbn rhsl`a onrtfhk mhsnfsns, Ofc`rhns ar`jsfturftnm aft w`ucm pr`vhmnhka`rjfth`k fd`ut ofc`rhns ar`j f s`uronlk`wk t` hkornfsn mhsnfsn rhsl (Tna. =8).Wn o`kshmnrnm tbn rno`jjnkmfth`ks hkourrnkt o`ksnksus rnp`rts fs wncc fs tbno`jjnkts (Tna. =7) rnonhvnm hk rnsp`ksnt` tbn 4557 FKUTJ rnqunsthkgo`jjnkt `k wbntbnr tbn mnocfrfth`k `aOfc`rhns ar`j sfturftnm aft sb`ucmo`kthkun t` dn v`cuktfry `r wbntbnr htsb`ucm dn jfkmft`ry.

Dfsnm `k tbn rno`jjnkmfth`ks hkourrnkt o`ksnksus rnp`rts fkmsupp`rtnm dy jfky o`jjnkts, wntnktfthvncy o`kocumn tbft jfkmft`rymnocfrfth`k `a Ofc`rhns ar`j sfturftnmaft hs k`t knonssfry dnofusn tbn fj`ukt`a sfturftnm aft dnhkg o`ksujnm ofk sthcc

dn `dtfhknm ar`j tbn t`tfc sfturftnm aftmnocfrfth`k ncsnwbnrn `k tbn Kutrhth`kAfots cfdnc. Fmmhth`kfccy, fs whtb t`tfcaft, o`ksujnrs ofk sthcc usn tbn pnronktMQ a`r sfturftnm aft t` put sfturftnm afto`ktnkt hk tbn o`ktnxt `a f t`tfc mfhcymhnt, o`jpfrn pr`muots, fkm pcfk mhnts.B`wnvnr, dnofusn tbnrn hs str`kg

nvhmnkon fss`ohfthkg bhgbnr hktflns `asfturftnm aft whtb bhgbnr c`w-mnkshtychp`pr`tnhk (CMC) ob`cnstnr`c cnvncs,hka`rjfth`k `k Ofc`rhns ar`j sfturftnmaft ofk fsshst o`ksujnrs hk jfhktfhkhkgbnfctby mhntfry prfothons. ]bnrna`rn, wnfrn k`t pr`p`shkg t` obfkgn tbn ourrnktv`cuktfry cfdnchkg `a Ofc`rhns ar`jsfturftnm aft hk tbn Kutrhth`k Afotscfdnc fs spnohahnm hk 656.8(o)(6)(hhh).B`wnvnr, o`kshmnrhkg `ur pr`p`sfc t`nchjhkftn tbn mnocfrfth`k `a Ofc`rhnsar`j aft `k tbn Kutrhth`k Afots cfdnc(snn snoth`k HH.F.6.), wn frn pr`p`shkg t`rnvhsn 656.8(o)(6)(hhh) fkm (m)(>) t`

spnohay tbft tbn stftnjnkt Ofc`rhnsar`j sfturftnm aft, wbnk mnocfrnm,just dn hkmnktnm ukmnr tbn stftnjnkt `aofc`rhns. Hk fmmhth`k, wn frn pr`p`shkgt` rnmnshgkftn 656.8(o)(6)(hhh) fspr`p`snm 656.8(o)(6)(hh).

?. ]w` ]b`usfkm Ofc`rhns fs tbnTnanrnkon Ofc`rho Hktfln Cnvnc

Unr AMF rngucfth`ks, f rnanrnkonofc`rhn hktfln cnvnc `a 4,555 ofc`rhns hsusnm t` snt MTQs a`r t`tfc aft, sfturftnmaft, t`tfc ofrd`bymrftn, pr`tnhk, fkmmhntfry ahdnr (656.8(o)(8)). Hk fmmhth`k,

wn rnquhrn f a``tk`tn `k tbn Kutrhth`kAfots cfdnc tbft stftns, Unronkt MfhcyQfcuns frn dfsnm `k f 4,555 ofc`rhn mhnt.X`ur mfhcy vfcuns jfy dn bhgbnr `rc`wnr mnpnkmhkg `k y`ur ofc`rhnknnms, a`cc`wnm dy f tfdcn whtb onrtfhkMQs dfsnm `k 4,555 fkm 4,>55 ofc`rhnmhnts (656.8(o)(8)). Hk rno`kshmnrhkg tbn4,555 ofc`rhns rnanrnkon hktfln cnvnc, wn

o`kshmnrnm rncnvfkt rno`jjnkmfth`ksar`j tbn H@J jfor`kutrhnkt rnp`rt tbftpr`vhmnm nsthjftnm nknrgy rnquhrnjnkts(NNTs) fkm tbn H@J Cfdnchkg Tnp`rt(Tnas. 4> fkm >5). Wn fcs` o`kshmnrnmo`jjnkts (Tna. =7) rnonhvnm hk rnsp`ksnt` tbn 4557 FKUTJ, hk wbhob wn fslnmwbntbnr 4,555 ofc`rhns sb`ucm o`kthkunt` dn usnm fs tbn rnanrnkon ofc`rhn hktflncnvnc fkm fslnm qunsth`ks rncftnm t` tbnusn `a tbn NNTs.

Fk NNT hs f MTH snt dy tbn H@J a`rnknrgy hktfln fkm hs mnahknm fs tbnmhntfry nknrgy hktfln tbft hs prnmhotnm t`jfhktfhk nknrgy dfcfkon hk f bnfctby

fmuct `a mnahknm fgn, gnkmnr, wnhgbt,bnhgbt, fkm cnvnc `a pbyshofc fothvhtyo`kshstnkt whtb g``m bnfctb. ]bn H@Jsnt NNTs a`r fcc chan-stfgn fkm gnkmnrgr`ups fkm dfsnm tbnsn NNTs `k k`rjfcwnhgbt hkmhvhmufcs (h.n., DJH 3 4>) (Tna.>5). ]bn H@J Cfdnchkg O`jjhttnno`kshmnrnm wbntbnr tbnrn wfs f dfshs t`usn tbn NNTs a`r mnvnc`phkg f knwrnanrnkon ofc`rhn hktfln cnvnc a`rjfor`kutrhnkts hk kutrhth`k cfdnchkg.]bn H@J Cfdnchkg O`jjhttnn k`tnm tbftushkg tbn NNT t` mnrhvn f rnanrnkonofc`rhn hktfln cnvnc w`ucm rnquhrnjflhkg fssujpth`ks fd`ut bnhgbt,wnhgbt, fkm pbyshofc fothvhty cnvnc.

Aurtbnrj`rn, tbn nqufth`ks usnm t`ofcoucftn tbn NNTs wnrn dfsnm `kk`rjfc wnhgbt hkmhvhmufcs< b`wnvnr,tbn Fjnrhofk p`pucfth`k bfs f bhgbprnvfcnkon `a `vnrwnhgbt fkm `dnshty.]bus, tbn H@J Cfdnchkg O`jjhttnna`ukm tbft tbn mftf knonssfry t` usn tbnNNT o`konpt fs tbn dfshs a`r f rnanrnkonofc`rhn hktfln cnvnc a`r kutrhth`k cfdnchkgwnrn hko`jpcntn fkm ht o`ucm k`trno`jjnkm tbn fppr`fob (Tna. 4>). ]bnH@J Cfdnchkg O`jjhttnn o`kocumnmtbft rntfhkhkg tbn ourrnkt 4,555rnanrnkon ofc`rhn hktfln cnvnc w`ucm dntbn dnst fppr`fob fs ht w`ucm pr`vhmn

o`kthkuhty fkm w`ucm k`t nko`urfgnbhgbnr ofc`rhn hktfln fkm`vnro`ksujpth`k `a nknrgy (Tna. 4>).

Wn fgrnn whtb tbn H@J CfdnchkgTnp`rt fkm o`jjnkts hk rnsp`ksn t` tbn4557 FKUTJ (Tna. =7) tbft tbn NNTs m`k`t pr`vhmn fk fppr`prhftn dfshs a`r tbnmnrhvfth`k `a f rnanrnkon ofc`rhn hktflncnvnc a`r tbn purp`sn `a kutrhth`kcfdnchkg. ]bn NNTs frn hkacunkonm dyvfrh`us pfrfjntnrs suob fs fgn, gnkmnr,bnhgbt, wnhgbt, fkm pbyshofc fothvhtycnvnc (UFC), wbhob jflns ht obfccnkghkgt` o`jdhkn tbn NNTs hkt` f shkgcn

rnanrnkon ofc`rhn hktfln cnvnc fppchofdcnt` tbn gnknrfc p`pucfth`k. Aurtbnr, fcc `atbn o`jjnkts supp`rtnm tbn usn `a tbn4,555 ofc`rhn rnanrnkon hktfln cnvnc.

]bnrna`rn, wn frn k`t pr`p`shkg fkyobfkgns t` tbn ourrnkt usn `a 4,555rnanrnkon ofc`rhn hktfln cnvnc fs tbn

dfshs a`r sntthkg MTQs a`r t`tfc aft,sfturftnm aft, t`tfc ofrd`bymrftn, mhntfry

ahdnr, fkm pr`tnhk, fs spnohahnm hk 656.8(o)(8).

=. Unronkt MQ Mnocfrfth`k a`r Ofc`rhns

Ourrnkt rngucfth`ks m` k`t pr`vhmn a`rf MTQ a`r ofc`rhns. _ntthkg f MTQ a`rofc`rhns w`ucm knonsshtftn tbnmntnrjhkfth`k `a f qufkthtfthvn hktflnrno`jjnkmfth`k a`r ofc`rhns. ]`mntnrjhkn fk fppr`prhftn MTQ a`rofc`rhns, wn rnvhnwnm rno`jjnkmfth`kshk ourrnkt o`ksnksus rnp`rts. Wn fcs`o`kshmnrnm o`jjnkts (Tna. =7) rnonhvnmhk rnsp`ksn t` tbn 455> fkm 4557FKUTJs, hk wbhob wn fslnm wbntbnrpr`vhmhkg f pnronkt MQ mhsoc`surn a`rt`tfc ofc`rhns w`ucm fsshst o`ksujnrs hkukmnrstfkmhkg tbn ofc`rho o`ktnkt `a tbnpfolfgnm a``m hk tbn o`ktnxt `a f 4,555ofc`rhn mhnt. ]bn H@J jfor`kutrhnktrnp`rt hs tbn j`st rnonkt o`ksnksusrnp`rt tbft pr`vhmns qufkthtfthvn hktflnrno`jjnkmfth`ks a`r ofc`rhns (Tna. >5),fkm tb`sn qufkthtfthvn hktflnrno`jjnkmfth`ks frn tbn NNTs. A`r tbnsfjn rnfs`ks tbft NNTs frn k`tfppr`prhftn a`r sntthkg tbn rnanrnkonofc`rhn hktfln cnvnc fs mnsorhdnmprnvh`uscy, tbnsn NNTs frn k`tfppr`prhftn a`r sntthkg f MQ a`r ofc`rhns.Ahrst, tbn NNTs m` k`t fppcy t`

`vnrwnhgbt hkmhvhmufcs, fkm frntbnrna`rn k`t fppchofdcn t` f sudstfkthfcp`rth`k `a tbn gnknrfc p`pucfth`k._no`km, o`jdhkhkg tbn NNTs hkt` fshkgcn, jnfkhkgauc rnanrnkon vfcun hsobfccnkghkg dnofusn tbny vfry dy fgn,gnkmnr, bnhgbt, wnhgbt, fkm UFC. Hkfmmhth`k, MTQs wnrn nstfdchsbnm a`rtb`sn kutrhnkts tbft frn hjp`rtfkt hkmhnt fkm bnfctb hktnrrncfth`ksbhps fkm/`r dfsnm `k ofc`rho hktfln (>> AT 48=71ft 48=78< Iucy 68, 6885). Foo`rmhkgcy,j`st `a tbn MTQs bfvn dnnk dfsnm `kqufkthtfthvn hktfln rno`jjnkmfth`ksfss`ohftnm whtb obr`kho mhsnfsn rhsl `r

f bnfctb-rncftnm o`kmhth`k (n.g., t`tfc aft,sfturftnm aft, ob`cnstnr`c, fkm mhntfryahdnr). Hk o`ktrfst, tbn NNTs frn knhtbnrfss`ohftnm whtb obr`kho mhsnfsn rhsl `rf bnfctb-rncftnm o`kmhth`k, k`r frn tbnyhktnkmnm t` dn trnftnm fs f shkgcnrno`jjnkmnm vfcun tbft ofk dn fppchnmt` tbn gnknrfc ^._. p`pucfth`k. ]bus, wntnktfthvncy o`kocumn tbft tbnrn hs k`fppr`prhftn qufkthtfthvn hktflnrno`jjnkmfth`k fkm wn frn k`t fwfrn`a fky `tbnr mftf `r hka`rjfth`k `kwbhob f MTQ a`r ofc`rhns ofk dnmntnrjhknm. Fctb`ugb f jfi`rhty `a

QnrMftn Jfr36>;4565 68951 And 42, 456= Ilt 4?4556 U@ 55555 Arj 5556= Ajt =756 _ajt =754 N9SATSAJS5?JTU4._GJ 5?JTU4

8/12/2019 FDA-2012-N-1210-0002

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6628?Anmnrfc Tnghstnr / Q`c. 78, K`. =6/ J`kmfy, Jfrob ?, 456= / Ur`p`snm Tucns

o`jjnkts t` tbn FKUTJs supp`rtnmtbn fmmhth`k `a f pnronkt MQ a`r t`tfcofc`rhns, wn frn k`t pnrsufmnm t`pr`p`sn t` rnquhrn `r pnrjht suobmnocfrfth`k mun t` tbn cfol `a fkfppr`prhftn qufkthtfthvn hktflnrno`jjnkmfth`k `r `tbnr mftf `rhka`rjfth`k `k wbhob AMF o`ucm rncy t`nstfdchsb f MTQ a`r ofc`rhns. Wn hkvhtn

o`jjnkt `k tbn tnktfthvn o`kocush`kk`t t` nstfdchsb f MTQ a`r ofc`rhns fkmhkocumn f pnronkt MQ a`r tbn mnocfrfth`k`a ofc`rhns.

]bnrna`rn, wn frn k`t pr`p`shkg t` sntf MTQ a`r ofc`rhns fkm, fs f rnsuct, fpnronkt MQ mnocfrfth`k a`r ofc`rhnsw`ucm dn knhtbnr rnquhrnm k`rpnrjhttnm.

D. Aft

Hk snoth`k HH.D., wn mhsousso`kshmnrfth`ks rncftnm t` mnahkhth`ks,mnocfrfth`k, fkm MTQs a`r t`tfc aft,sfturftnm aft, trfks aft, j`k`uksfturftnmaft, fkm p`cyuksfturftnm aft.

6. ]`tfc Aft

f. Mnahkhth`kAMF mnahkns aft, t`tfc`r t`tfc aft hk 656.8(o)(4) fs fstftnjnkt `a tbn kujdnr `a g `a t`tfc afthk f snrvhkg mnahknm fs t`tfc chphm afttyfohms fkm nxprnssnm fs trhgcyonrhmns.

Hk 6887, wn rnonhvnm f ohthznk pnthth`kar`j Kfdhso`, Hko. (M`olnt K`. AMF6887U5=71) rnqunsthkg tbft AMFfjnkm tbn mnahkhth`ks `a t`tfc aft fkmsfturftnm aft hk hts a``m cfdnchkgrngucfth`ks t` ocfrhay tbft fontho,pr`ph`kho, fkm dutyrho fohms jfy dnnxocumnm wbnk ofcoucfthkg tbn fj`ukt

`a aft hk f a``m pr`muot (bttp9//www.rngucfth`ks.g`v/# !m`olntMntfhc6). ]bn obfhk cnkgtb

`a f aftty fohm mntnrjhkns hts pbyshofcpr`pnrthns (Tna. >6). _b`rt-obfhk afttyfohms frn o`jp`ukms tbft frn s`cudcn hkwftnr. Fs tbn obfhk cnkgtb hkornfsns,wftnr-s`cudhchty mnornfsns (Tna. >6)._b`rt obfhk fohms suob fs fontho,pr`ph`kho, fkm dutyrho fohms frn sthcco`kshmnrnm aftty fohms fctb`ugb tbny frnwftnr s`cudcn. Aurtbnrj`rn, tbnobfrfotnrhstho anfturn `a f aftty fohm hs ftnrjhkfc ofrd`xyc gr`up fttfobnm t` fobfhk `a fclyc gr`ups o`ktfhkhkg ofrd`kft`js `a wbhob tbnsn sb`rt obfhk fohmsfrn o`jp`snm (Tna. >4).

Wn mntnrjhkn tbn fj`ukt `a tbnjfi`r jfor`kutrhnkts (ofrd`bymrftn, aft,

fkm pr`tnhk) hk f a``m pr`muot dy tbnhrobnjhofc o`jp`shth`k. Wn tnktfthvncyo`kocumn tbft tbn pnthth`knr mhm k`tpr`vhmn f sohnkthaho dfshs `k wbhob wno`ucm rncy t` pr`p`sn t` nxocumn fontho,pr`ph`kho, fkm dutyrho fohms ar`j tbnmnahkhth`k `a t`tfc aft dfsnm `kmhaanrnkons hk obnjhofc o`jp`shth`k.J`rn`vnr, tbn pnthth`knr mhm k`t nxpcfhkwby wn sb`ucm mnahkn t`tfc aft dfsnm `kpbysh`c`ghofc mhaanrnkons hmnkthahnm a`rsuob aftty fohms o`jpfrnm t` `tbnr afttyfohms, nvnk ha trun, fkm k`t rntfhk `urourrnkt fppr`fob t` mnahkn t`tfc aft

dfsnm `k obnjhofc o`jp`shth`k.

]bnrna`rn, wn frn k`t pr`p`shkg fkyobfkgns t` tbn ourrnkt mnahkhth`k `at`tfc aft. Wn rnqunst o`jjnkt `k `urtnktfthvn o`kocush`k tbft fontho,pr`ph`kho, fkm dutyrho fohms sb`ucm k`t

dn nxocumnm ar`j tbn mnahkhth`k a t`tfcaft.

]` ocfrhay wbft wn o`kshmnr t` dn faftty fohm, wn frn pr`p`shkg t` mnahknaftty fohms hk 656.8(o)(4) fsfchpbftho ofrd`xycho fohms o`kshsthkg `af obfhk `a flyc gr`ups fkm obfrfotnrhznm

dy f tnrjhkfc ofrd`xyc gr`up. ]bhsmnahkhth`k hs o`kshstnkt whtb `tbnr

shjhcfr mnahkhth`ks a`ukm hk kutrhth`kfkm obnjhstry rnanrnkons (Tnas. >6 t`>=). Wn rnqunst o`jjnkt `k tbnpr`p`snm mnahkhth`k `a aftty fohms.

d. Jfkmft`ry Mnocfrfth`k_noth`k=5?(q)(6)(M) `a tbn AM&O Fot rnquhrnstbn mnocfrfth`k