(b)(4)(b)(4) CONFIDENTIALCONFIDENTIAL
(b)(4)(b)(4)
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MayMay 16,16, 20142014
Ms.Ms. ChristineChristine A.A. Sannerud,Sannerud, Ph.D.Ph.D. . DrugDrug EnforcementEnforcement AdministrationAdministration ' ~T6 DrugDrug && ChemicalChemical EvaluationEvaluation (ODE)(ODE) 87018701 MorrissetteMorrissette DriveDrive • ; Springfield,Springfield, VAVA 2215222152 ' • • '
. (b)(4);(b)(7)(E)b)(4);(b)(7)(E) Subject:Subject: requestsrequests ReclassificationReclassification ofof CodeineCodeine (for(for conversion)conversion) InventoryInventory
DearDear Dr.Dr. Sannerud:Sannerud:
(b)(4)(b)(4) manufacturingmanufacturing registrationregistration (b)(4);(b)(7)(E) jbX4)(b)(7)(E) requests[requests thethe DEADEA allowallow usus toto reclassifyreclassify 694,518694,518 gramsgrams asas basebase ofof CodeineCodeine (for(for conversion)conversion) toto CodeineCodeine (for(for sale).sale). ,
WeWe produceproduce aa materialmaterial atat thethe (b)(p>X4)4) |sitesite calledcalled codeinecodeine alkaloidalkaloid technicaltechnical (CAT).(CAT). TheThe problemproblem wewe havehave isis thethe CATCAT producedproduced atat (b)(pw4) |cannotcannot bebe usedused inin thethe productionproduction ofof CodeineCodeine PhosphatePhosphate duedue toto ourour DMFDMF fifilings,lings, soso allall CATCAT productionproduction forfor codeinecodeine phosphatephosphate isis produced inin thethe[W) (b)(4) site.|site. OurOur customercustomerpW^manufacturing b)(4) manufacturing registrationregistration b)(4),(b)(7)(E) numbernumber fb)(4);(b)(7)(E) | hashas expressedexpressed anan interestinterest inin purchasingpurchasing CodeineCodeine PhosphatePhosphate forfor aa grandfatheredgrandfathered codeinecodeine antitussiveantitussive application,application, meaningmeaning wewe cancan useuse thethe CATCAT producedproduced forfor (b)(4)(b)(4) site.site.
BetweenBetween Nl(b>(4>4) ]wewe havehave aa largelarge inventoryinventory ofof material.material. InIn 20122012_ wewe werewere producingproducing CATCAT forfor conversionconversion intointo HydrocoHydrocodone done Bitartrate,Bitartrate, andand wewe plannedplanned onon sellingselling tonstons ofof thisthis 'material'material toto "(b>(4>4) asas perper ourour contract.contract. (b)(fb>W4) jbackedbacked offoff onon orderingordering HydrocodoneHydrocodone Bitartrate,Bitartrate, leavingleaving usus withwith aa largelarge inventory.inventory. BecauseBecause wewe areare notnot producingproducing anyany HydrocodoneHydrocodone BitartrateBitartrate thisthis yearyear (or(or nextnext year),year), wewe wouldwould likelike toto taketake twotwo batchesbatches ofof CATCAT in inventory at (b)(4) (b)(4) in inventory at[bi(4i b>(4> that[that isis inin thethe quotaquota classificationclassification asas CodeineCodeine (for(for conversion),conversion), andand callcall itit CodeineCodeine (for(for sale).sale). OnceOnce thethe DEADEA grantsgrants thethe permission, thethe reclassifiedreclassified CATCAT willwill undergoundergo aa purification process andand be convertedconverted intointo CodeineCodeine Phosphate.
(b)(4)(b)(4)
Vol. I PagePage 715715 CONFIDENTIAL
WeWe requestrequest thethe DEADEA considerconsider thethe informationinformation presentedpresented andand allowallow |(bX4)(b)(4) toto reclassifyreclassify upup toto 694,518694,518 grainsgrams ofof CATCAT producedproduced asas CodeineCodeine (for(for conversion)conversion) toto CodeineCodeine (for(for sale).sale). ThisThis will allowallow usus toto avoidavoid productionproduction ofof CodeineCodeine (for(for sale) starting materialmaterial andand reducereduce ourour inventoryinventory ofof thethe recentlyrecently slow movingmoving CodeineCodeine (for(for conversion)conversion) material.material.
ThankThank youou forfor yourour considerationconsideration inin thisthis matter.matter. Should you havehave anyany questions,questions, pleaseplease contactcontact meatf^)me at b)(6) ~ px4)(b)(4) | considersconsiders thisthis commercialcommercial informationinformation privilegedprivileged andand confidential.confidential. WeWe believebelieve thethe releaserelease of thisthis informationinformation will likelylikely cause [^^substantial(b)(4) substantial competitive harm.harm.
V erv trulytrul vours.Our (b)(6)b)(6)
DEA Materials ControlContro Manager
(b)(4)(b)(4) 2
Vol. I PagePage 716716 Substance 2011 2012 % Change 2013 % Change 2014*2014' % Change Amphetamine (D,L)(D,L) 9,703.48 10,938.9510,938.95 12.73%12.73% 10,928.2010,928.20 -0.10% 11,921.3911,921.39 9.09% Amphetamine (D)(D) 10,597.7010,597.70 11,725.3011,725.30 10.64%10.64% 11,597.1011,597.10 -1.09% 12,584.0012,584.00 8.51% Cocaine 48.53 44.03 -9.28%-9.28% 39.63 -9.99%-9.99% 37.17 -6.21%-6.21% Codeine 26,170.71 22,758.28 -13.04% 21,716.68 -4.58% 22,238.3822,238.38 2.40% DihydrocodeineDihydrocodeine 107.21107.21 75.02 -30.03% 36.22 -51.72% 6.76 -81.33% DiphenoxylateDiphenoxylate 462.60 413.01 -10.72% 406.20 -1.65% 382.07 -5.94% DronabinolDronabinol 110.82110.82 106.13106.13 -4.24% 110.92110.92 4.52% 115.78115.78 4.38% EphedrineEphedrine - 1,535.521,535.52 1,973.121,973.12 28:50% 2,083.14 5.58% 2,203.60 5.78% FentanylFentanyl 539.85 575.07 6.53% 548.23 -4.67% 544.38 -0.70% HydrocodoneHydrocodone 64,933.52 63,163.25 -2.73% 61,575.69 -2.51% 59,479.05 -3.40% HydromorphoneHydromorphone 1,675.271,675.27 1,912.391,912.39 14.15%14.15% 1,926.071,926.07 0.72% 1,857.151,857.15 -3.58% LevorphanolLevorphanol 0.32 1.541.54 378:02% 2.33 51.13% 2.53 8.41% LisdexamfetamineUsdexamfetamine 12,336.1812,336.18 14,001.2914,001.29 13.50%13.50% 13,653.6513,653.65 -2.48%-2.48% 14,525.0114,525.01 6.38% Meperidine 2,303.07 1,885.591,885.59 -18.13% 1,537.311,537.31 -18.47% 1,364.131,364.13 -11.27% Methadone 7,639.42 6,776.34 -11.30% 5,804.38 -14.34% 5,531.24 -4.71% MethamphetamineMethamphetamine 13.8613.86 14.4014.40 3.87% 13.0913.09 -9.11% 12.4812.48 -4.65% MethylphenidateMethylphenidate 19,212.6319,212.63 19,534.8419,534.84 1.68%1.68% 17,949.1317,949.13 -8.12%-8.12% 18,613.5818,613.58 3.70% MorphineMorphine 30,435.83 28,705.35 -5.69%-5.69% 26,266.30 -8.50%-8.50% 25,445.23 -3.13%-3.13% Nalbuphine 61.42 63.60 3.55% 42.02 -33.93% 39.88 -5.08% Naloxone 391.27 430.32 9.98% 478.98 11.31%11.31% 497.20 3.80% NaltrexoneNaltrexone 4.56 0.00 -99.98% 0.00 1-100.00%100.00% 0.00 0.00% Opium 84.96 81.02 -4.63%-4.63% 77.44 -4A2%-4.42% 77.41 -0.03%-0.03% Oxycodone 70,885.82 66,702.94 -5.90%-5.90% 60,308.91 -9.59%-9.59% 59,796.79 -0.85%-0.85% Oxymorphone 2,655.74 1,958.251,958.25 -26.26% 1,865.581,865.58 -4.73% 1,951.681,951.68 4.62% PentazocinePentazocine 839.71 698.43 -16.82% 563.20 -19.36% 411.38 -26.96% PentobarbitalPentobarbital 79.12 46.62 41.07%-41.07% 24.25 -47.99% 29.66 22.34% PseudoephedrinePseudoephedrine 104,476.73104,476.73 93,931.68 -10.09%-10.09% 93,125.29 -0.86%-0.86% 100,386.58100,386,58 7.80% RemifentanilRemifentanil 1.051.05 1.111.11 5.83% 1.161.16 5.09% 1.201.20 3.53% Secobarbital 20.78 15.6715.67 -24.59% 11.9811.98 -23.55% 10.4810.48 -12.52% Sufentanil 0.05 0.05 -2.53% 0.05 -7.93% 0.04 -24.36%
*Estimates"Estimates based on JanJan-Mar-Mar 2014 DataData
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E51): 22.003000 ALLNLPRODINEAlUVLPROOINE Vol. I Page 719 \ J J ' i u 8 w» 2010 I Bask Clam 0142-0 0111.111 APOI § I W0101112,1s» l ? i A 7) Poo I S Eel: Anal PO PI equoato0:a 5.000 (WS Eat si 5F 5 * n 5 % § X 000000* i 5 I a § 401 Pmjacted knontory Adi A.1.1c.s, o c i 8 2012 Storm o. 2015 Tots/ PO 2013 low/nay 21:11i PdojeeNd Ezpores 2:314 Po/omen Sen 0 2010 Peo)oono1 Ma PeoMoo2 a/moo 2014 0E4 § 2 Nom MS RIKPleited MO 3014 Re•taed MO 2012 2012 0/4/ MO Said ? 4 ft C 2 S I m K DEA S. ft Salt• 3 3 § J 3 Company a 3 2 K 3 J fn S 1 ? f ! r i. § Ul 0.000 0000 0.000 5 000 0 0.000 13000 5750 «A 5 000 5.000 0033 0 000 0000 o 003 » § P cr X (b)(4);(b)(7)(E) S § 0000 4.000 lit V 4 Ow COW (A §15 5000 5 000 lis 0000 0 000 0000 0 000o a.000 0.000 1.000 § 2.750 ill ill S'S §g P 111 ill 115 ill ail 5 I I 1 s MO Tota11: 10000 10 000 § 2014 ilnal1n1lial APO; 150005 2014 SOW Ravlafd APO: 0.000o MA Eat /20i • knitla1APCI• 1 • FDA EMI: 15.000£ y!s fill! El 5 nil (2304 Innfal Is 1/AS 0.o fill APO • 1 • 1115 EMS 15000 m 5 > CARF£NTANIL r 2 "0 0) CD -n| DO Page 720o Vol. I CO &a*fcBaskCUM Clow: 00M-A00934 10182016Initial 1313121APO *PaWcrtc«fw«l» W41404018 PDA E»l. TftUlTWAPQ PORaqueatfri: Requite!: 4.230.0054.230.025002000 FDA Pal: IKS1415E«t* E.t HO DCA UQ Salt* ««2DUU« iftara e* 2015 Tcud TO 2CIJ lr»*fiU»ry 2014 U *vta 7014 too,K-todSa'e* 20<3 f»reje«« EapottJ an 4 rrejectad ln%enic*y 201«£>BA Pr. A*q A**H Cafc Companycarnosny OCADEAHum km 2013H*q»miMtMO2012008,441.03 M4 MO 20112013Sale. Seel 20x32043 DrA 81C1 % el 21:13 5106 Snare er 2012 Taud PO 2013 0454,1ort 2014 Projected E4 parts 7014 Prolected Sales 2015 Prop.-00 Expatt MI 4 Projected 1000010/0 2014DM P(010‘44.0 0nwnteay Atq Avall Gk oooo 0 000 5000 ocoo 1 000 •soot 0.000 5000so)o 0.0000.000 0a000 MO 30350.74330250.765.030000 00.000MO 00000 000 0000 0.000 5.000 0000 1.003 ox 0.000 |(b)(4):(b)(7)(E)(b)(4);(b)(7)(E) 3.431.313 123 7.534.625 C4» 0DO3 30.216.71B COO 0 000 fi.7SC.482 000 1.(24700 000 24.031,070 250 M.33,000,000030000 om mo 34.50&5M24,506,591.000000 29.400.042240 ,04/.tTOOD 3S3SQ.76S00336220365.020 01*10.801 2.43E313 128 7,534,025000 0000 30,500,718.000 0000 11,750.482000 1.024,702.0:0 24.031.070 250 KOToW*:140 Tata: y>30300005.000003000000 ?4.S0eS*tt©24.506.500.000 20123142104110194.14 f(mi tnHkJ ATO; APO: 55.0O355,030000000 CM 003 20142014f 214.3JliMi fUvUW 2.0.4•441/4P2:ATO: OC0000CO FDArar,Cat eg:r2o14|281 4 toMal tninlalAPO APO' • 11 • FOA800.C>l|: Eat:: 35.000.00022.030002COO 00.0 IUSIMSE*C DBC(201 (20.1414;ttal4 Initial flPO APO« •1 1 •114.0IIAS Ell): Est): 55,000.00355.0.00,000COO NntaPieter kC« 2M53055Pre P InitialInitialAPQ: APO: 40.000.0C4140.000,0000CO 000 wtthwish btrfTu:bterren 50.CCO.0C050,000,000000oco (b)(4)b)(4) b)(4)b)(4) CODEINE (FOR(POP. CONVERSION) Vol. I PagePage 721 J J J 3 s % I 2 0 K r") Basle clam 905049 201$ InIWI APO Workshvirt* m I -- 32 2 { Ssj I 70181P0o R4oussr.40: 24230293.940 FDA Est S* w WS5? 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VON PecjeAted tceenton, 00A lAcc 2016 2004 out 8 E Acquitted 61Q MO SIMS %I:0201354W _ r I ^ V x 0.000 o to 000 13221 0 000 4.000 0.000o 5000 0000 22356007 o 0005 m 5000 0.000 3.760 5 .- s 1.5 (b)(4);(b)(7)(E)X S "If 0 000 0060 14300 IIS oof ssf IIs Hi o s §8 «» ft IIS 15056 II HE ss? 0.000 ADM isl 1.000 « m 8 III 10.000 00.000 0507 1.022650507 C500 K 12.066 lip ' i § 5 5 I 70111s: 15.000 156005 j» 2614 final Wig APO: 15.000 1 P 1 o 2014 FNOI ftwelscd APO: " 0000 * ill 5 <5 FDA Ell: 12014100,4 APO.D 1 t FDA Ett6 15000 £ (P» Si UU 5 II D H im WO Egg: C2614 in1061I APIA • 6.I44.5 6.41): 15.000 § I 0515 PropOted 66041 APO: 15002 I SI " I 58 tekh ISS buf!sr: 16.750 8 a R 3 s I o s BULK (NON c OEXTROPROPDXYPHENE, 5 "O QJ CD -vi l\J Page 723W Vol. I CQ BtlkCkai:Bask Close: BtZC-O41790 2012015S lnllU!APQWofk»ho«1» fnIllat APO Workithoets FDA Ecu Total70141PQ P0Requeued; Requested: B.0.113.000111.000 FOA Est IMS16,5t*»: Eat Shar^of MlSToUlPQ 2011 tn*e«tlory 2014 Ptojected EiportS 2014 Projected Sek* 2015 ftefcdatf Ciport* 2014 Prefecled ln*i Aflj Avail Cak HQ SsssssiCompany DEAAuftiDEA NW, ma2013Waq^Uad Requested HOMO W1*Kf»««lMa2014 R orrued MO M1J&i«2013 Sales »13DCAMQS4k*2013 DfA MO 5ales *Aol2013&ak»V. 012013 41.14. Sham of 201575141PQ 2013 Inverdory 2614 Projecurd Elporls nil Protected S4105 2015 Proledr5 Expo Mc 2014 Poojedr4 Inremory Atli Avail Cal; 140 e.ooo 0.003 SOOO ODOO 1 000 3.750 1250 (b)(4)b)(4);(b)(7)(E) (b)(7)(E) $000$000 5.00C5.000 ocoo0.0013 7.SM.7947.956704 ODOO01300 occc*400 0.007 Dm 5.0:0 6.000 1000 3.750 1250 0.000 3000 O.D00 153*5 MdS9 17.817 SOOO5.000 5.5.000WO 0.7840.704 7.684.7.158.764764 00.0000OO 08720.872 U914.54545 0500 3.000 0.030 15945 14659 17617 9.1 10 983 202.423 000 COOO 50.750 000 0000 154.051 OCC 211817250 241283 985 80.CCO.00080500.000 B0.500.0DC50600.000 7.M7.CCO7687.050 7.884.7S47606764 1.0001,000 9.110.188 202.423.000 0.000 55250.000 0.000 164,063.000 211617250 241 203665 0.000 1,00Q.DK> OtKC OOCC 290 220 578873 1.0OOOOO1,000.000 250000MAK D2CCD200 7.994.7847.966.704 OCOODow 02280215 136136.960050 0.000 1,000.030 0.005 0000 290220 675.825 241 ,870.878 WQToUh;MO fo14b: 81.01001610.000000 802SD.OOO69,360000 241.970.078 20142614Final Frolln11161APCZInitial API* 80,80060506.600000 70145014Final Ffn.lReriMd R.riMMdAPQ: APO: O.OCO0.000 FDAFDAExtEat: (2014(10/4Initial APQAP13• • 11 . FDAFDAEft): £11): M.EOO.DO060,660.006 IMS Eat |2014(2014lmtulAPQ'1 APO' 1* • «3NOEftIV Est) M50800000.600.000 20152015Prcpoeed Proposedk»U*1 01010APO; AM: 8161,100.000,100 000 wth*50 JiXbirfk*:25% Duller. 101375501375000003 DSHYDROCOOEINECMHYDROCODENE Vol. I Page 724 136046jiIc Ciao*:C!a»t: 012000120-0 20151811W2016 Ir.lllj! APOAPG WarNshaotsWorMta** ToutTaUI POPO Raquelat:Haq*«tt«a: 9.153.0008.U3000 FDAFDA EU:Em: 1143IMS Est:Ell: CompanyCompany DEA0£AN«m Nun 20152015 RaqueamdRtqu«M«0 MQMQ 20142014 ReWitaRevtaed MOMQ 20132013 SatesSato* 20532013 DEADEA MCIV Q Sales 14 of 2013 Saks Share x12015 lowl PO 2013 Inventory 2014 Projected Everts 2014 Projected Soled 2015 Projected Exports 2014 Projected Safes H«f 2013 Sale® SharW 201$ Total PQ 2013 lnvanl«ry 2014 Projects Etporta 2*14 Sales 2015 Pnv«c4 Eaporta 2014 Meernotytt**nvny AdiA 449170tels:tfQ Toiali: 111010.00061,010 COO 40.290.09060.2fiO.OW 20742014 Flea!Final innialInitial APO:APO: 60.600.000fiO.6O0.0M 20142014 FinalFinal RevisedR*vii«f APQ:ATQ" 0.0300000 FDAFQA EatEaC 1291412014 WadhVtUt APQAPQ *11 aFDAFDA Es*Esq: so.soq.oco00.600.000 11431M3 C31:Est: (2014(2014 InitialInWal APOAPQ • •11 • •1145IMS (opCat}: 90,600.000B0.600000 20152015 ProposedPropatarf inMalinitial APQ: 31.10061.100 003000 withwttn 23%25* buffo:bufTar 101.375000101.375X00 J DIHYDROCODEINEDIMYDROCOD&NE Vol. I PagePage 725 r o o> s o I £ 2 o I? « *2 "WI ) 2 Omsk Class: •..rel 2015101141 APO WOrkfolteots 8 1 3 1000 VOA Est: Total PO Raquerled: 3 1559 Eat. 3 ill 1 £ ill T» S S31i a IMi f ! « U I I S s •s s ! I •« S o "S r s S * I r i°Ss 3 3 = E * | s 5 s jlll rs a Sill ? I s a olil * s O 5 s ? a 3 j | O1 i 3 X 2014 Projected Iroovotory3 AN Aveil Cafe 2014 ReVIted MO 2013 Silks 21393 DEA MO Saks IS of 2013 Saks Shim of 2015 Total Pa 3013 Inventory 2014 Projected Espotts 2014 Projettid 561t1 2016 Pro}ecte 0 Easelsg BIS Kum 2014 Riquested MO o §11 Company § Oa I o ~ rtoI § * s III UJ s s I b 0.000 0200 0.000 I! 0.500 1.500 2.000 2000 0000 702127.000 axe 0 ON § 1.500 § O b i N H (b)(4);(b)(7)(E) "S3 § o 0010 12464.000 0.001 13449.000 3 0.000 27.000.000 ,0,110./50 27.000.000 702122.000 0.001 § 0.000 I 455.002 O b I ~ = 5 b S O 070900.000 580,000.000 701.757.000 702122.000 0090 0.490 185.000.000 10.400.000 570.400.000 0000 334.793.000 046,070.550 § S N § a" § » 1 I 5 14Q Teta':- 647.402.000 5040023100 I'll sin I f Has lilt 1014 PI/Warn:1M APO: 600,000.000 1 ssa 2014 Mal Revisal APO: 0.000 II 2l li •5 ? VOA Eat (30141n Mal APO' 1 • FOA Eat); 800,000.000 £ » 1910 Eat: (1014 Inatal APO' 1 • 114$ (Mr 000,000.000 £ x : E J( ? .C s I | 5 5 * I if 3 I! 1 £ ? & s 2011 Proposed Initial APO: 1070000.000 1).2144•NI 2014 perefro sevised APO end (b)(4)j mud iow request value la 7014 i 14110 s 25% bolter? 1,737.500000 uf 5 o it * | S 0: 5 a OIPHENOXYLATE (FOR SALE) CO CM N- CL (D cn Vol. I Pagero 726 / IWKBasic cms;Mass: 91B04J95104 20201aIB IffilltftoitlaiAPQ APQ VtfMkMttetSWoduthcots FDA E»1! TotalTotalPQ PO Regulated: 50005.000 FDA Eilt IMS(415 E4tEat 2814 PnfNiM S»l«t 20 U P/"0|tc»d E*ports 2014 Projected Inventory Adj Avail Ca!t Company QEANufflDEA Num lJ1iKeqwe«ted2015 Requested MOMO 20142014 RjtWm3Reeked MQMCI KlJSaWa2012 Sales 20120133 CCA CEA HQMO 5.-i»541os %X ofof 20152013Sain Sales StoreShareof o12015JfltS Ton TotalI PQRC Mia2012 Inventoryinventory 20142014 ProjectedProjerata EifottaEtyma, 2014 Projected Dales 20{0 Projected Upon" 2014 Frojeeted Inventory Adj Avail C.els cooo 1044 2.059 0JM 0206 1000 5 000 C.744 0000 0«00 2058 |(b)(4):(b)(7)(E)(b)(4) (b)(7)(E) 20002.000 20002.000 0205 one t000 5.000 0244 0.000 apix 0.000 1.544 HQMCI total*;Tattle: 20002.000 2.0002.000 20142014 PMlFInslInBUJAPQ: initial AP= 2.000 20142014 FU*lR«*iwtlW>Q;Anal RoVialt6 APO; 0.CO30.030 FDAFDA IvtEst (2014 1aUa| APQAPQ' t 1I *a FDAFDACtl): 30002.050 IMSIMSE*l: Est <2014MU InitialintUal APQAPO'* 1 1 •»a IMSIMOE«tJ: EMI: 2.0002003 ETHYLMORPHINE Vol. I PagePage 727727 r r. V n 2 5 8 < 1 £ 3 I O 5 Is S? i? .. WOrtalheels (U < 2015 10[4141 APO £5 B44144 Ots: = s 6 5 £ 3 i FIJA Ul 1002.2713,255 in 7s4411 PO Requmsted: s IMO Est: I f ! imim a 1 ""rssjsa a 1 i aodoooooO s s rnyr I I 2 " 2f § 4 a s {15183838 | E°s'SS8S° 2 8 £oooaoooa rt s j ieaSSSSKS a s's 2 A I i iS§S8§l§8 I s. jssssnss -*°*tl8§8 I z 8 8 Ig i ? 2 Total P0 2013 ['amatory 2014 Protected Exports 2014 Projected Sales 2015 Projected Exports 7014 Pro4c;:led IraIntory Arri Avon Fait NO 2014 Rer1oed NO 2013 Sales 2013 DU% MD Saks 14. 04 2013 Salem Snared 2013 1 i DEA Num 2015 Requested o Company 5 d 8 °rn§r 9 r-~ -O -C 0.000 4 000 0.000 1 1.000 3,626 | 0 000 0.151 i 5.000 0.000 995,926.931 0000 1 1 5.000 o 1 aS5§s2§ a 3 8 * I 8 " § (b)(4) (b)(7)(E) § 63,542.000 0000 too.woboo 0.000 50000.000 153.66%000 37,083,924 i 131.000000 36,960 000 191,026.931 0017 q 200,000000 1 1 o S 1 1 0.000 1.711 2256 iJsjS 0.000 0.600 5„J!8 931 0.000 0,541 1 Dla I Jiis* 0,538 926.931 o 2.000 1 2000 i •> 8 " S * 1 S 02.330.000 , 0 003 1.300000 10.090.500 0,112.451 101000 0.000 § 9.062000 0,009 o ,3.030 998,9213,911 § 13,91 14,151,003 1 o 8 s S S 5 § 230.549.000 445,120 000 0.000 260,1153000 518.865,000 0245 245,863.607 0,000 § § 475, 245,042.030 091.826,435 o I DX.000 451.271 000 § a 5 w § § 3 S S 122,00 000 8.50,527.000 0000 380.205.000 511.514.500 547,201.705 298.656 000 § 0646 § 645.039.000 509,92E131 ° 070,000,000 010,000.000 1 eg 8 5 5 8 * § 17.597,000 0.000 33,000000 0,000 13,000.000 25,107.750 0.004 4,474.954 § § 35.000 .000 4,460030 896920,971 Q 16,000,000 1 3. «» 8 S * 5" 7,214.900 4.050.000 ' . 13.500 000 6,600 100 0.000 995.925.4131 0.000 0.000 0000 0.000 5.500.000 0001 § 5 ? " 8 8. I I i 110 Totals: 1,604,837.000 1,459,029.033 § I iiii ill! Ills Ills ? 7014 F1nul loNlal APCr. 1.657.000 000 § ° 2059 Final 13tvlsed APO: 0.000 £?? I I !! 5 fx FDA Est:12954 InDIA1 AK' • 1 • FDA Esty 1.637,000 000 § I s 1145 Est 12014 Initial APO' 1 • a45 040. 1.687000 000 o,is. ?! i IS If 7015 Proposedif ',aim A/542„. 1,557,000.000 whin 25%6x10.11 2,118,750.003 Li- I I FENTANYL Q. CO CvJ h- G»mw O£ANum_20t8 *equ«ll»d COmpien. 0EA Nom 2010 lieeeetted 140MO 20/42014 iterisadK«Y»»d MOMO 20132013 SalesSaMa 20132011 01/1.110CtA UQ SeesSai«t 11.% ofof 2013541es201J SaW* ShamSSw»o<20l5TettlPa at 2015 Total PO 20132013 lnyerdoiyinvwUxy 20147014 ProjectedPreset** EvansEaporu 20042014 ProjasiedProjected Sales5*ta» 2015201SPfcj* UQ Tet«la: oooc ottSatab: 101.005.000101.00s.000 0.000 01,004.0008I.CC4.00C 20142014 Flnalfinal MedalInrtlal APO:APQ: 0.0000 000 20142C14 FinalFinal Revised APO:APG: 0000oooo FDAFDAEsI: Ell: {2014<2014 MOW*1*1 APOAPQ •* 11 4* FOAFDA Fro:Esl): 0.0003COC MSIMS EreEtC 0014<2014 kraalInRUl APO'APO * 11 •111.3IMS EsWE%lf 0.000aooo 20152013 Propoied10441APO:rropottd Initial APQ: 110.000.000110.000 000 1•110i*tlh23 V. HyDROCODONEHYDROCODONE (FOR(FOR CONVERSION) Vol. I PagePage 729 0»«tC 04110 C1.444:CImi: 9417-I3snj~a 20152015 InitialiniCLal AFC(AFQ WorkstvertSWorXtheeM 7001TotalPO Po 41.004.00; 4%577262.74092J77.»2.r49 MAEFCACit; 1145IMSC«4: Esl. Company DEADEAHi*2_ailS Not., ADS Req44,4LedRM}ueit«l 140MQ 2014 R0414441 MO 2011 Sees 2014 £ 2014 TUvimX MQ 2013 20152fit>0eA«aS4»»i °EA ma &On %% 0.1ol 2011 a.... sm..SK*r» ofOf 2011WHToUl7041 POPO 10112013 4...erserytnrerJ0«Y 704 ', sleeted Expe.M. 2014 Prorectod Sai.. 2016 Projects41Expartt Pr044.,:.0 ...May *di Avail Cat. MO 2014 Pfc^oetod Export* 2914 Prof«<**d 2016 Prot»d««J Exports 2014 Prc+mXwl fciv«T*ofy Ad, AvrfCifc MQ (b)(4)(b)(4), (b)(7)(E) SOCK1yooa 5sooo DX 0 ocooODO 4300,101.3534S.0M.169.JW 0.000 7.000 5.751 0 000 4.030 0.000 11000 3 (b)(7)(E) 0 000 0000 0.0S1 o ooo 4.000 9X00 IMC 0.100 3.7M 0 IM axpaa700,000 000000 01,400 000 0000 45,001,164.155 0.000 0.000 MO . 99,400 OOQ e.ooo 45«|.tM3S5 0 000 0 000 0000ocoo 00M0 200.0000002cc.eoo.oco 0.000 60.016000eo.owooo 74.550:0077 ,25.450.000 0X00 74 * 50 000 129.450 COO 20.00070 000 20.00020000 1.5753.575 45,655,165.15546.CM.16S.WS 0000OOOO 7,167 74.093 0.000 5000 0_000 69094 70.570 7.567 74 093 0.D0Q 5 000 0.000 69C34 TOJ70 96.460 169.000000 96 460 31UMG00 175.079.0001?S.0T«.ee0 19,742.00039.742 000 45.005,1691-5545.0W.l6S.i5S 0.0010001 0110700101.901001 12/56000• 2CSJ.0CC 9.000 166,000.600JMO0C000 0000 5,000700 140,502.750 3.44.101:01 QXQO o.ooa 5X00000 140. SC. 7 50 344.909 001 20,000000000 3Q.COa.O0O.000 13,274,159.00013.274,159X00 =AS2.824.00022 852.426 OCO 40.0«5.0W,18SJ5S,3169353 0.5070.507 47.045459.00447.090.499 004 7,747.741 s ,I74.005 12,200.00112j»0X00 21,471.711000 0.000 7,102.029 SDII 70267,5C2,750 26 000,900000 .170JXX 23,464.231000 OOOQ 3,102.529.000 20.26I.5CZ.7S0 2B.00C 000000 7702.000.0013,603.000.000 1,0155.910.0001.865.91 0X00 144,021.000149.721.009 47.060,169353tS.Ma.KUSS 0.0030 003 105,456.809308.406 809 2,071,070.0002X31 0.000 7.100.000000 0_000 1,903,000003 2,574,410000 16,706011 ,670 008 OOCC 3.1 OC.OOCXOO c.ooe 1,963.000000 2.S3841O.O00 38.706 311 25002,00035.003,000 000000 22.158.367.00022 651.367X00 10.075.427.55010 075.426JSC 45030,1691504 SOW. 169.355 5.401 37250,155.119a 3.055.630.000 0.000 ?9.001.000.000 0_000 6,565000 COO 19,960,002.175 29,002,000.000 0.401 37750.130 090 3 655.035.000 0.000 29.0C2 OOCOOO eeoc SWM0MQ 19.9W.302.17S 79,003.000. OOO tosco,aoTcalia.ooo.ooo.ooo 2,184.7190002. 104.7 18.000 0054/2000605.442 030 45,068,169.05545.066.169355 0,011 1247,70.3411747.705X43 220 .C*40.030 0.000 c4f,c000koel 0.000 1,290,594.250 4,162,152 429 0X13 2*M.M0.M0 C.C00 tAU 000000 oooa 4fi,6«.OOOOOa•60,.°00 AA 3^95J94JW 4,167.152 429 11,600.00001011, 600.000 .000 6,081,512.0006.901 .532X00 102552_000103J52.0CO 45.066,109,35045.0Cfl,169JJS5 0.022 214.019.097214 C 19.997 1,70.502000 0.000 4.150000.500 4000 1203.600000 0,120,275_1X 9,120,275.530 O.OC2 3J4S.S03X0O 0.000 9.1SO.OOO.COO ooao 1 703.600000 8,120^75.500 6.120 275JOC MOMQTaWh; T001.7: 76790,020.9906Q.T9a.02S.OC0 51,555,191.000 67,796,405.600 13J 59.1 91.WO 67.rn.409.MO 20143014F*«IWtl«IAPG: F1.11-00.41 AF0-. 79,700,0907g,7M.CC0 /CO300 2014201 4 Finalfinal Per.4441Revved AFC!:APO: 000O.DOO 706E4.0fDAEAtp014iutijtAPCr (2011 4,41411P 141 • GOAFDA ES*Ekt): P3701,00370,700,000.000 000 las1US 010CiC (7014(8314 intl.!Mil! APOAPQ . *11 • 4ikes1*8 Est):£»Q; 79,74079,?O0.M».Q0Q.000 000 HYDROCODONEtrfOROCODONE (FOR SALE) Vol. I PagePage 730 . J J ? i 5 I § u 1 Initial APO W0 Basics CL.n•: .1640 2016 0100066 r. X - < i FDA Cm, TOW ii Pt1 Rwlsws1e0: 5.247.006.420 8? 114.5 E•1‘?? s | 3 f I e 3 s 1 f 3 3 § 140 ? 5 v » 5 201 P roihrted 3,9199. 4.7 AdiA91.21 C.k B g c P.Jecard Salr• E.7ort4 70" 7', 1449•4,9 8 S B Total 201114;v941ry 7414 Prolec1941 2014 3 £ 5 » E9perts 8 r 1 PQ Company DEA S N00 :016 0.exp.m....d 470 7011 RwoLseel M0 .0132 Saks 20130U 140.3.44 1(.91 2111 091es 31.999 917013 § - i * § o b oI 0000 1 000 5750 0.000 2 4400 . 0000 - 1000 0000 4900 3474,774079s 0,000 0900 0.049 m I .1 « § (b)(4) (b)(7)(E) i « I o 36,00000C 57.523.000 I © = 0.000 30.000000 0.030 64.040003 62664 74700.000 4600 2.674,775-s 079 0.000 0 000 0.000 s 8 i s § o 0,000 63.344 59.5.15 30000 »J 40,447 0000 14,000 )0000 10.000 2421 4674,774079g 0.000 4.267 o 1 i 5 1 1 a o 0000 0.000 54.600009 016,000 000 233 C 000 0.003 112.00000 114004000 77,030 003 0.060 4514005.079g 0000 0000 § s % 1 S 1 8 134000003 53,6412.021 569,S44,000 3 V 0,000 3 5.900000 366449000 a 623.176 000 514996.044 074919.114 3474;775.079S 0 1 PO 4(46,004.655 202715 006 § 1 1 3 3 1 251,600300 1 522.491500 356000,000 S h> U 5,000 156.000400 0.200 u 251,602.0.00 336000 000 444200000 114,796.000 4$04.775.079S 5.094 411200.32:2 s § 1 1 3 r9,301.7f0 8 333,529,005 14 1 0,000 1,160000,000 3 U» i* 917,620000 '32 S 000 1645,000000 1,179.610400 997.232=a 2,57,4,773.079 2279 1463,733.533' 197659.000 6760 1 3 i 1 1 n 1 1640.111.061 1 0.000 024,000 200 2.000.000 300 Iff U 3 2,059,000 000 ii 655,997,350 9400 2060.040.139.4 1474414009 1,1691101469 3.574.775,079-S 0.379 2.419.9)6.344 g§ss§§S§s£ SSSSSSisgn sttiigs 8 1 t Mil.- I 888888888* 8 8 poioi 114730.444 .5 !;S8S8;S5» 64.000000 96,674000 as;ssi 0.000 8888K8&88 IsSiLjc. — SsSSslili5 ooa^apoppc 3S333!liaT ? 3"sbbIo> 9.300 113.500.1)00 '3 IIIIIIISl1 i.SgX? illlihlil 11,110000 Mill. £ 65,370.169 140,600.090 07.701000 44642.000SSbsIo.p 3,574,776079 0.012 4.495,209931 1 i i I ' 14991c.S 4.701261 000 4.266472 060 g I 2014g F43.1k.tui AKr 5,4003432.000 § p8 2014? Fit91114•1.,-.1690: 0440 § 5 900,E4t, 70141.'9:al A.Pci • 1 • FI2A E60: 5,400,000000yi li § is* till 1 II PAS Eat 17014 9,13.1fill AM • 1 • MIS Em); 5,406.000.900 • i | 2019 Pro06190 i APat 5.03 0 .000.000 ii s if §* ii with 2.VA b4.414, 6,250,000ss 000 * S o s FfYDROVORPHONE3 CO -vl CD Q) "0 Vol. I PageCQ 731 Baal/Oa*U ClamClass: 0126.00226-0 20151nIttal2015 initial APOAPO WorkaheetaWorksheets TotalToUl P0PO 010tarotettPs^wvstod: 0.0000 000 FDAFDA Eat.•Est 1MSIMS Fatl-tfc CompanyCompany DCADCA NamNwm 20152013 RequtstedAenutsutf MONO 20142M4 ResitiadRevlsaO HOMO 2012»1S SilasSabs 20132013 DEA MO Sates 14(42013 Sales Sraft .51 2015 Total PC. 20111:we/dory nu Projected Exporla 2011. Projected Sales 2016 Projected EA alts 2014 Projected lowensory Atli Avail Vale MO OEA MO Salts % of 2013 safes S*a« ol 2013 Total PO 2013 Inventory »1 4 Projected L*?ora 2014 Projects a So Ms 20t» PrsjteUtf Eaport* 2014 Projected Inventor* AdjAvallCafc MO 2.000 O.OQG 0,000 0200 5.500 0.000 0.000 1.500 (b)(4)|(b)(4);(b)(7)(E) (b)(7)(E) 2.0002 000 2-000 0.000 11000o.ooo 0.0000000 0.0000 000 a. coo oocc OSOG 000 1.300 tSOO 1,5001500 mqTouterTotals: 2.0002000 2.000 410 2000 1,0001.W0 20112014 foalFinal InInitial tlal APO;APO; 4.0004.000 20142014 FinalFinal Rtel►edRevised APO:APCJ-. 0.000oooo FDAFDA Est;Eat (2014(2014 InIttalinitial APCIAP« "11 • *FDAFDA Eat):EslJ: 4.000 I MsIMS Est:Eat: (2014(2014 loft:alInitial APO'APQ • 11 • 1110IMS EEst).10: 1.0004000 I( SOMETHADO N£ Vol. I Page 732 Baslecuat: Class: SM8-09143.0 20120165 UiftCal WhigAPQ APQWorksheets Worksheets FoulTotalPQ PORequested: Requested: 05030.503 FDAFDAEsc Est: IUSMISEH: Est 201 4 Projected Sales 2015 Prodded Eaperls 2014 Projected inventory Adj Avail Cak: Ma CompanyCompany DEADEAMum Num 20152015Requeued R44404440MQ 44412C1 20144 Rcvu«tf RoutedHQ MQ 20132013Saks Saks 20132013Dt* OVAMQ MOSales Sales *%of ofM13 2013Saka Saks ShareSnareof of2 1.S00 MQMCITotals: Totals: 2.0002.000 2.0002.000 1.500 20142014Final Finalinitial lfints1AP0tAPQ: 3.0303.000 20142014Plrul FinalRevised Ravli40APQ; APO: 0.0000.000 FDAFDAEat Est(2014 (2014tnhial UMW'APQ APO• •1 1 • FDAFDAEat): Lap 3.K»3.000 IMSIMSEat Est(2014 (2914Initial InitialAPQ APO •t I • IMSIRSEatf: Eat): 3.DM0000 LEVO-ALPHACETYLMEL£VO-AI»PHAC£TVlMETHADOL THAD OL (LAMA(LAAM Vol. I PagePage 733 r«i r r a 3 4 3 Q s 1 1 a « 4 Cask Clan:n 0210-0 2015 105041 AAQ Workthteie 11 Is 2 3 £ o § Total PQ Requested:? 0.000 GOA Eat: OAS Er:: £ ? 8 « S « 1* « n 8 2 o 2 a « 8 «JS »* 1" 21 8 •J 8 s | i- 8 t I a 8 V» £ T3 u II i { 5 si o» v si SI 8 5 1§ a II * s II 4 s § « s 4 * C e- 3 er 1 i I | 1 ems..+..•. OPA 4y.n » 9401144001Exports 2014 Projected Sales 2015 Projected Exports 2014 Projected 1:04440044y Attj Avail § g & 2305 5caucsted MO 2014 Arrived 2013 Wiz 2013 05AP:0050u Si 44 201334144 Share of 2015 T01.0 PO 2013 Ins•entary 2014 Cho Q MO MO «n s ci 8 8 ' ri o ' 1 - 01 r« (b)(4);(b)(7)(E) 2000 2.000 0.330 0.320 LOW 0100 2.015 0.000 1.500 0.000 i.sse 3.022 2.530 S I pi § n § m ? MO Totals:w 2.000 2,000 2.538 Ifai I §811 sals H ills s'oss ' 2014 Final 10041 APO: 150.00 ! 2004 PAW Revised APO: 0.000 S a f! FDA Ea: 120111:011141 APO • 1 140A PAW 150.000 5 3 IMO Est (2014 India] APQ • 1 •« 1PAS FAQ: 150.000 * if £ 1 a a w 1 2015 ProgArtedl! - IOW APO: 4.000 with 25%K buffer.I i wi 5.0031 O a —I § Ul LEVOMETHORPHAN£ X h- Q- co ^r Oxon:m.4y PL*0E44,hum, 20152015Request** lie.que41,41UQ 14Q 201*2014 RavrsetJRevisedNQ 61131 20132013 SafeslIsSes 201320, 3 OP*0EA MQ410Sales *% <4 20132012 Saw*Sates RtiaMal00.* el2015 21113 TotalTotalPQ 2013 Inventory ?ui22044 Pre^xtad Experts 2014 PrOjaetad SaWk 201 J Projected £*pcXtC 2014 Projected InVrafcny Adj A»«d Cate MQ 5.4144s 01 F12 2013 Inventory Pioj.n.d Exports 2014 Protartad Sales 2015 PrOKII.<1 Expottc 2014 Projected Lnr.,,,, AziAv.d c..,/‘ MO 3.000 3.000 OOOC • 1 .907.000 o.occ oooo 0000 0000 D 500 0000 (500 (b)(4);(b)(7)(E)(b)(4) (b)(7)(E) 2.000 2_000 0 000 ' 1907900 ckoco o oco o 000 o oco o soo 0 WO 1.500 1.SO01.400 22.(100000 2.600.000 1.5M.OOO 1.907 000 i.oor.ooo 1.000 4.1 »7 000 42000 6.000 2.09*000 0 000 Ul«000 12ZQOQ0 2,600.000 2.500.000 1.546.000 1.907.000 1,907.000 1000 4.107.000 42.000 0.000 2.094 000 0000 1 .2 I 0 000 1,210403 2,4.0GoOt UQMO Iot*H:Totals: 3.6C2.0002502.000 1,600.00a1,600.00o 2.CQ2.OO0 21,4222_1)00 J01*0014 Fin*]Fieull.1111.41APO:IflRUI APQ: 1,0001,000900.coo 20142014 FinalFirulRevised Revined APO:APO: 0.0000.000 FDAFDA E«LELL' tWI(20144 InitialInkLal APQ111, 13-. 11 PDAFOA EtlpEslr 1.6001,440 000000 WSmos Csi;to; 1201442014 WilliIntliatAPO APO *'11 41145IMS E»I]:Eon: 1,6000001,600000 IQISPrnpcMd2015 Proposed InitialInftlalAPQ: AP117 3,7002,700 000000 wifti.11125% 257. buffer:btrtf.r 3.37SOCO3.175 000 LEVORPiLEVORPUANOL iANOL Vol. I PagePage 735 fiiiicElaslc Clan:Class: V..O-Disaaa-0 »lfi2010 1011161APCIWork6heettsInitial APQ Wortt$he C9flig*aYCOrnoanol OEANufflDEA Nom 201$R«qt*S«cdMQ2015 RequesSed UP 2tM4R»vHfdMO2014 Revised MD 2&n5aW»2011 5aSas 20132011 D£ADEA UQfAC1 S«ta«Sias 7.Df20«Sa*i%of 2013 5then Stwi*Shore ofat 20121115(Total lola11710PQ 20192010 141.0..1'lnv*n1<*T 2(1*7614 Pro^cte^Projected Ci^rtsExports 7414TOIL Projected SainSalem 301570151P UQHO totals:Totals; 1.260.316.000U6ft.51C.C00 mftiawo710.010,003 757.242A28757;242.4N 2014 FinalPift•I InitialLnkial AAQ:APO: S.KXKXMM05,000000000 2014 Final K»vH» Qther«r considerations:ceesiceennarre * has not submittedsuNWtted requesthequelL as noff 5-1-14.5-1.1 a„ leftl0Ft voicssneflvoicerni.a 5-27-14 requestingrequesting update atel business plans inin 2015 5-70 sutmithrd- SOISAppfceetKxis,2055 appfioatton.s, rrvependiiv)roeperidtne requestrequest * 4.000fcg.4.000kq. will leave APQAINC1 3€tfromnet from 2014 (b)(4)(b)(4) (b)(4)(b)(4) MEPERIDINEMEP ERIDNE Vol. I Page 736 Q«ak134 • ic Cut*:Cass: »23*-0923Z-0 2016 IrtitkllititiAt APQAPO Wocksl.ets ratalTotal PQPO Raquestxd:R»qw**U4; o.ooo0 006 F94HUE**: Est IMS0222 C«t:E41: CMTipMrCempeny CEAW«mCEA Rom 2(]13R. MQLAO Tot"H:To2AN: 3(b0i Otu 3000 2«002.000 MUfln.12014 final Mttal166141 APQ:APO: 50005003 2014 FinalFinn 1 Rat,4444RovW APQ:A006 00000.000 FOAFDA Ed:CH: 1201442014161122100W-.nbl *PQ • 1 •a P0VOAA Cil}:(412: Jooo5000 1146IMS EstCsS 12014(2914 kiftil!NitLI APQAPO 4. 1 4a NS515E.1),£tf); S.OOO3.000 NEPERIOINE-INTERmEDIATE-AMEPEHlOlNS-lNTERMEDlATe-A < Vol. I PagePage 737 0.sic '292.0 20162019InKUl Ini(1.1APaAPQ W<**&bo©ttW042410019 ToUlTotalPQ PO Ra^twtltd:12 ocontl. 11000000 fFDAda E»i:E., IMS:Ks £•*:Eat CompanyCompany P£AHy*lOSA Nrnn 20152015 RaipiMWdFteRueetod UQMO WM2011Rt,lM4 R*91.11120UQ 20132011SakiSAM 20120133 DEA DEAWO 140 Safe*Sales %>7.9fOf 20192011Sakt Gales Sfuia5h... ofof2015 2915 ToUlCoia190TO 20120151...yr/or/5 Inaatitory 2DH201. PfOiacUdProjoc9a.£ Export.*p tfQ Total*: SQCO 7.G0C *4.011 2.0 ToUls: 5 002 7000 14.011 2014I014 FinalFlrullnasIAPO:lnHUl APQ: 9O009 000 20UFhilR»»l*««JAPO;1014 FlimIRrrised APO; 0.OOO0.000 fCAFDA E*CEst (201(20144 InJiWIni11.1APQ APQ•M 1 • Fr OADAUM:EH}: 90009 MO m111.5 utEst (soi10010i wtu0)6.1wom*us APO .1 • us u\y.t.is: owe0 OM MEPERlDlNe-lNTERMEDlA7e-9MEPERIOINE-INTERMEMATE-13 Vol. I PagePage 738 (Utuctsa*:0■010Ctiat: 92M-092140 20162006 i«vu»1Initialapq APOWort»arwta Wor1111.916 7ouiTotalPQ PORnjLieittd: Roque at& 0-0000.000 FDAF00€«: E11: WSCsl-Otis Est Fin/Tina D£AMi*nDEAN um 20120155 Rk PelvestedUrtlKJ MO140 701*2014R«*e»«1 Res1sadMQ MO 20132013S«*» Ss1e3 20152013DEAfcK2S*tart DE. 14.1&Bars f,%of of2013 2013&•** Sates Sh*r«Shareof 012115 20157 MQMO ToU(»:Totals: 3.QO01.000 1D005 000 2-«O02.900 20UF%u1toiWAPQ;2014 Final UAW APO; 5000tow 201*2014f itatal(Ml ««*(vsd RarfsodAM: APO: 0.0000500 FoACci:ruA€ se.(201* (2014 LnllilIoILIAPQ APO.4 11.* FDAFDAtit): Est): 5000S.030 fUnosS FSCEst(M1* (2014 InkUl101:U.(/03'1sWQ 1 *«3 ve3 E«l)iEst); 5.6.000COO mEFER,DINE.INTERmEouvis.cMEPeRlDlN6-1NTERMEOWTe-C Vol. I PagePage 739 &sic6*iic Cies,:CUss: 924C.0M4C4J 20162015 Int1141ItlMlI APOAPQ WarIustoosteWorksheets T4411Total POPO Requested:Requested: 5.000S.000 FDAfDA£»i: Eat: WO[Matte £tt: ciataacomanypa fry DEAD€AWi*n (iim 2016201 6 itsquatt441RequestedMg MO 20142014 FlauntedRevised RIOMQ 20110041201 a Sales 2a122013 CEACEA MOMQ SatesSa'44 %* at 2013 Sales 5fiereStiM*ef»lB 912014 TotalToUl POPQ 2013NliUiverrtCfY tnventory 20142014 Projected Etports 21114 Rejected Salsa 1016 Projected Evora 1914 Projected Inventory Adj Avail Cats MO of 2013 Sales Protected Etpohs *« 1 4 projected SaMa 2016 Piejected Eaperts 20H frroj«ted Inventory Adj Avail Celt MQ 5.0005.000 5000 0.003o.ooo 00000.000 0000oooo 0000 0.000 0.000 4400 0,000 1.000 3150 (b)(4);(b)(7)(E)(b)(4);(b)(7)(E) sooo 0.000 c.coo aooo 4.000 DO00 1.0O0 3.150 0Q 293250 5.0005.000 50005600 0.000o.e» 0.000o.oao 00000 000 0000 0000 0.000 A.000 0.000 4.000 3150 O.OOfl q.ooo 0.000 1.000 COO0 4.0C0 3.750 4.0024.000 MOMQ Totals:ToUlf : 10.00010 .000 10.00010.000 4.250*260 20142014F1IUI Flul !MAIOInHUI APC.1:APQ: 150201SO00 20142014 Melrin»l RevisedRaised AP10:APQ: 6.000oooo FOAFDA EstS2g110011d(MUMill APOAPQ. 11 4« FDAFOAt*1): tag: 15.20)1S.C00 IWOIMS EstEst: j2014l»H In111.11Ifihlal APt0APQ • •11 • 1045IMS Ecu: 15.63015.600 / METAMETAZOCINE2OCINE Vol. I Page 740 bukMAL C*m«:MUM 9202300WO xni2015 tnnuitntualAPQ APOvyotKinMii Woritshoos ff) topiTotalpq PO r»4w»iRgoammd:«t: iB.3M,re714,134.1171127m; rOAEif:404 Eat lMSi*tIMS Est -.04?017 2013 S*U» 2013 DEA HOSMi % <* »13 S*lei sru<6 of 2G1S Total PQ »ii iivMiofy SOI* Fiojeen^ fc*p©r» 20M Projected &9i«« »1 5 Pro;««ttd E»twrt» 2014 Pk>)«ci»j lovHRtorr W|Av»uc*ic uo Ccxnpwy44010.07 CCAorAMum mums 20123155 Re ia394.95T.07S UOTOMli:MO Totals: 20.166.015.20.166.011000030 13.026.67415026474000 CCO /0.354057415 20142014 Flets11,60•1infiA wo: APO: 25.500,25500,003030COO 000 20143014 1MFind P«vto*«d4...64.1APQ:APO: O.OOOQ1:13D FDA£»tFOA EAt (2014(2014 UiftUItnitlalAPQ 420.1• 1 • FDAFDA E4lfcEs* 7S.500.0CC73400,040.000QOO |USEfctpQ1*'nttUiJ04.6 Est Inittra APC-1*APQ - 1 • IMSIPS E»aEsti: 24.29495026.298.950.000K*> ©OwrCOWconsiderations: am /14020:1113: Fbi?4T1(b)(41 dosingrJostng as0311503BMuctiuftes aiRItfta the end400of o120142014 20142014140MQ 6,376.000.0006,376000.00D 20120133 MQ MO 6,3216.329.000023000 POO V*aIna nflwnear suppGarfs)guppGsr(s)foi for ttictraj»lcottf|(hW4)the cul10m021(h)(41 I*IF «*rat 6PPar«.'4apParett el41Itti this Vimelime caieisales InIn201320 10 K*|fori — 4| AKCOSARcos 5,816.0005,616.000 000000 (b)(4) IMSHAS 3,100.0003,10000.000600 20142014 PQPO 5.673.7650.573.764.00COO 20132013 PQPo S.617.1MCCO4,617.13,3080 AfiCOSARCO$ 2C142014 loptop diitrftmoraOtstrilemors i«caFvingtecatvIrig w1,4 T1 TT P~*2014 03.24.4•1 CmOlaiDuke.rtwfc*» D.1.4•34H• mg. ore, C.Newars Tsw ar WPM OcaHaDeo 20 61.3e• .fer Kmkm. p41w1 C*tK»01191 •i/ NF*N rfiR< >ie>s" 1.7BS.320.723 :3 .0 Tm.:4)•44.02,40) (b)(4);(b)(7)(E)(b)(4),(b)(7)(E) vv !we: 11,04 Ae.s••• 1,786.320./23 : PE7rtA00N6'W0QiPPETHArANv4sce. 'L 7.230, 53P.W5.03S630,035.035 ;- METn4DO»it;r?&ee«ktr, Koattrzsee, CMCH IPErapDEino.T,T MlliMMllV:i.LKAPOJt 52*141.796629,141.796 2,845.49T.K«2445,497.556 • M£THAOOt4EMETHADONE Vol. I PagePage 741741 1 L MeasureMeasure : :TotTot KgKg (Absolute)(Absolute) TotTot KgKg TotTot KgKg TotTot KgKg Carr/12/2011CalYr/ 12/20 11 CalYr/12/2012CalYr/12/2012 CalYr/12/2013CalYr/ 12/2013 L i (b)(4)(b)(4) i 3,764.83,764.8 4,115.14,115.1 3,100.03,100.0 3,856.73,856,7 2,542.82,542.8 2,399.32,399.3 0.00.0 98.898.8 2813281.7 10.910.9 13.113.1 15.315.3 6.96.9 6.56.5 7.97.9 0.10.1 0,10.1 0.10.1 0.00.0 0.00.0 0.00.0 C © 20062006 IMSIMS Health.Health. All rightsrights reserved.reserved. Page:Page: 1-11-1 27/05/1427/05/14 Vol. I Pageage 742 N BasleBasicClass: Class: 025449264-0 20152015 InitialInitialAPQ APQWorksheets Worksheets TotalTotalPQ PQRequested: Requested: 0.0000.000 FDAFDAEst: EM: IMSIMSEst: Est: CompanyCompany OEAUumClEA plum 20152015Requested RequestedMQ MQ 20142014Revised RevisedMQ MO 20102013Sales Sales 20132013DEA DEAMQ MOSales Sales %%of of2013 2013Sales Sales ShamShareof of201 2015S Total TotalPQ PO 20132O13ImonUuy Inventory 20142014 Projected Espprts Exports AdjAdjAvail AvailCslc Calc HQMO 0.000 7.500 (b)(4);(b)(7)(E)(b)(4);(b)(7)(E) 10.00010.000 10.00010.000 0.0000.000 22.287.908.00022,287,508.000 O.OOO0.000 0.0000.000 0.0000.600 0.000 7,500 5.0005.000 0900 668,946.500 1.025,700.000 1,148.000.0001,148,000.000 822.975.000822.975.000 194.755.000194,755.000 22.287.908.00022,207,908,000 00090.009 0.0000.000 66.287.00066.287.000 0.000 666.946.530 1,025,700.000 0.000 2,170,972.000 O.OOO 10,574,712.750 16,200,000.000 16,200,000.00016,200,000.000 11,928.84590011,920,645.000 10.78010,780285.000285,000 22.287.908.00022,287,908,030 0.4840.484 0.000 2,170,972.000 0.000 10,574,712.750 18,200,000.000 4.4,560,000.000960,000.000 5,070.739.0005,070,739.000 4,002,598.0004,002,598.000 22.287,908.000222875008.000 0.1800,100 0.0000.000 1.258,1251,258,126.000000 O.OOO0.000 4,746,648.7504,748,648.750 4.960.000.0004,080,000.000 22.18S.7O5.0Qfl MQMQTotals: Totals: 22.308.010.00022,308,010.000 17,622.369.00017,822.369,000 22.165.705.000 20142014Final FinalInitial InitialAPQ: APQ: 31,100.000.00031.100.000.000 20142044Final FinalRevised RevisedAPQ: APO: O.OOO0.000 FDAFDAEst: Est: (2014(2014 InitialInitialAPQ APO ' 1 FDAFDAEst}: EMI: 31.100.000.00031,100,000.000 IMSIMS EstEst: (2014(2014InNialInitial APQ APQ'' 1f »t• IMSIMSEst}: Est): 31.100,000.00031,100,000 000 7015 Proposedposed InitialtaltialAPQ: APQ: 27900.000.00027,500,000.000 (b)(4) (b)(4) I buffer:buffer: 34.37S.000.00034,375,000.000 OuterOther considerateconsiders 1(b)(4)b)(4) has not [tor 2014 oror 2015 in 2013|(b)(4)b)(4) "MQQ waswas 9,000X91"9,O0O1c9 Lvaszeros zero not doarwnoCie Iss pickedpicked upup b)(4)b)(4) justomcts,stomers,so so addadd 50%50% ofoftheir their 20132013 quotaquota toto proposedproposed APQAPO METHADONEMETHADONE-1NTERMEDIATE-INTERMEDIATE Vol. I PagePage 743 V v. 3 S*2I 5 Hii I 3 % — Ilri I j m ?: Hi m 9 S $ a " J ss 8 M H n U P P P 11 1 B Slol I till B a * tj a » s G6 SUISSE ! S I fcSlllf.t 5 Q1 iiiiiiis 2 a 2 - s i - 2 8 m S I S ?j 2 Issllooi § iiiiiiis V?| g oissS p ° iiiilii r § c VjIlilifiSV, V| V< Vj v ^ t> 8- §|8§lllr 1* Vol. I I 8 I I oooooaoE f llsS'ill 5 * U 5 z I 0) s3N1HddOhl CQ ^ 0A § CD 8) SSs -^1 u u- v-'Sa p 2 4^ '» i* v* n at a b J 8sa3s88° 4^ » 8 fi* I* a | 8 3? (i401S)JIANO d 8 h 3 S o o i f? I S 8 § I I 1 ! M 3. I e o d o 1O p p iiiiiii a 7 A O ^4 U S. § ~ g 5 s 2 | § 1 1 i 1 1 „ | §!§§§§§* 8 «A p DO 0 9 O p O 1 i i 1 1 i i s I a I- sa i | | ill § i § i I £ 1o§?^spo0e * 1 1 =* IS2SS§1^ J a m 38. ! ISHj I m*§88 r r C < I i c I! .. it Rafe Clna: 1300.13 1015 Initial ANA Workstepts 31 £ 5 « « I B "i TotaJP0 Regulated:I 42,041.144197 FDA Ea: i DAS Est: -.031 £ I ? 5 j- 8 £ I-'IIPI11 1 Iipil1!!1 i JJ!3MIJ£I9 * 3 3 I s i§ggiiiii§ I iodoOOOOO® t"S°«»32I° •i I r>Mii(r JflMOKJOJOO puis I smsisiu | I Z siiliiiisi ill 70000POO<*0 i§lH5|fi§ § DEA NA 2016 ReemearEd 110 3514 A.A.:a ma 2063 bales 2013 DEA MO Sales %of 20 43 Sales Slure el 2011 1001 PO 2013 kwentant 2014 P.4..ted Exp.n. 2014We/1e...1 Sales 20111 Proicael EaRana 2014 R1011010.111, Company 1 160RY 841 Av.a Cafe Ma H-HflilPI i " a" S lu "pgiiiu 0000 COM 0000 4.000 0000 1.000 5000 5.000 35,757 656635 0.030 0030 § 3 0.724 5 ! 3170 (b)(4),(b)(7)(E) s 20.000 100000 2.113 2030 150.076 0030 ' 0000 201.576 - 100.000 15,737E5664S 0.004 "»* § 1 172.934 zu 213206 P " a s?;rm §111111 218600.003 0.000 ? 0.000 0000 0000 0.000 0033 h 0,000 210000600 isisuss.ns 0.600 § 216.000000 e " ' 0E00 " a' rtS »-I 1 y £ ifl * - * 0.000 4,700005.000 0.000 4,703000.000 4,776,667.003 3271207040 3,918.311,102 71.327000 1 71.226.000 f • 3 35,757056.635 0.091 ,63s..39S.500 c S s s § 1 S 5,142043377 j 2 M = O S 15,463466001 11209250.000 0000 63,72250.000 43603000030 14244200000 12010014000 15,733E16.631 4,)+31 5)11,436.000 639260 000 1 14,1112.416.300 17492.597,030 5. am a 2 ' " 11 COCO 0000 1.002003 11003 i 1000.000 1,020.000 0.360 0.000 0.411 1 oval 350.000 35,707.606.631 a * 750033 s 1 s =- a N 5" 5 I j Jf *» S R 6.721E29000 0 000 21,061,000.000 0200 5357033.000 "- zkoaz000.000 16.047,148.030 0.440 10.226.130.492 1 10647.631230 " I? 16,135,576AM 30,707,656.635 a 23 06S 3 S g I 032.1 43 1 "" V 7.060020000 0000 1003.000600 0806 1200000.000 3.40.000.063 4,200.010.000 0.004 10,797.656415 0,000 0.000 0200 0 1 1.650.000.000 o S 1 a * 450000000 0000 0.000 35,87.656,63s opm com o.cco 0060 490,000000 cox 0.000 0.000 430.000.000 tf I 1 y> 2 I | = 8 i s * I 1 * MO /nubs: 34, 100.10.000 42,964.554.0041 52,047,456302 lili Slag III a i § §§11 2014 Fkull rt1.1AP170 30,003,000.003 "•§ 2014 Final Reves..3 APO: . 11 Ms) §3 t f# s n FDA Est 0014 In16.11 APCI • 5 • Pal 50000,000.030 s s § 111S Eat 12014 laZial APO '1 ..13/0 Eat): 4043%030000 V S fL 1 s 2 MORPHINE (FOR SALE) h- Q- m Vol. I Page03 0) 0014 Propectad Sales ProiectiK1 E.,.•:,4. 2011 Prolodsd h.,...Ason, A.44,..i Asa ConyCoaspartyny OEAN«nDEA &km 2015201.5 R*qu8«t*«5Requested 140fc*Q M142014 R«wtw MQ14,1 TOUM:Tout,: 543,450.000511,450,003 15520048S.OOOOOO 000 1,394,2172501.M4.217JM 26142014 F«mIFisal InflWAPQ;IniltAl APO: 500.MO.000500.000000 20142.01/ FlmlFlAatRorlso4APG:R«vh*4 APQ; 10000.000 FDA £«iEst: (HlAtnUai(2014 tnItIll APQAPO 1• 1 «• FOA £«);Est). 500,000 000 IMS111.5 Cit:Est: (2614(2014 inKkJInittslAFAPQ,Q *. 1I • MSist0 £*t):Est): 5OO.D0C0QQ500.000 00.3 1012016J PmpwdPropos4d ln«WAPQ;Lnittat APO: 550.00C0M510000000 %*fthwhin 1SA.IS* twflef;bisfler. 617,500617,500000000 OPIUM,OPIUM TINCTURE Vol. I PagePage 746 _ ' 1 BalkBaiteCUtt: Class: M1Ma61,-0 2Q162016 Initial APQ WortsfHMrt*Worhstseets ToulTotal PGPO Requested: «.i2*.coc86.126 000 FOAFDA Eft:E«: !MSIMS Eri:til! 2044 companycomoanv DEAPEA HumNum 2016016 Requestedmvnttd MO 10142014 Revice.11,40Rrvtied MQ 2012012J SalesSale» 20132053 0EAUQDEA MO SakJSal. * MQMO TciUti:Total.: 56.000.60053.000.000 5«513,271.271.000 COO Se.lW.-J5050.150 150 MI2014 FinalFlml UliiWkullal APQ:*PA: 50.000.62,000.DM000 2014 finalfi6.l RevisedBavlMKl APQ:APO: 0 000OW FQAFOA Est,Est. (201C201411110..1« Initial APQ ' 1 s FDA Ertl:Eatj: W.OOO.OOQ94E01000 IMS11.,..5 Ell,C«: (2014(2914 Initial APO '1' 1 *OAS(MS Est}till: OC.OW.OOO90,000.000 OPIUM, POWDERED Vol. I PagePage 747 I § §§ § "1!!!!! I r I'MIII " Utii 5 R si§§§gg§ I — MM 1 a ISSIIIBS j€»OOQOOO u 8 "11 s o §§!§§§§§ Joflodooo <3 8 CO *1111111 si ^r h- ii I "s-SS s § CD O) r SlSSIsll 8 03 risir* CL l -*35 If 2 5§SS22ii Vol. I a o o o o Q o I •t j S ' I 2MMMHfH slllllll t SS I §1 IS 3cf SSi- o' o" I issiisi § ^ 2 2 £ 3 3 8 £ n A A I " 3 s .'HiSif ! §H§ §§18 I g§1? 5 §5 V I'll7, SV,5 K *A i3 r g i c si 5 I t C LU si «! S! 1 i. P a — 5? ii£ a. S- y r I n ! is Q s gin if BASIC OASS:C1.455: 2015201S initialInitial Quota WorksheetsWortubeets OripJvbMOrlpsuk. 9330 Company: (b)(4) 3T5TF TOJOT1000.0 1U0U.U31104.01 Request:Request• 1200.0 1131.0 19007.019000.0 5351.0 3264.0 612.5612-5 430.0 Cuf/cntGwent Year MQ:MO: 1100.0 1674,01674.0 (burrIbupienorphine teransphine pd]pd) 20732.20732.0D 3204.0 324.0374X3 (PO(PQ Inventory]Inventory) 327.0 Year tndend Inventoryinventory 3.2 2535 1570.82579.8 100702007. 0 amt n«arftd substance MQ yfeUyield arm needed substance MQMIt yield amiamt needed subs*ybta 1000X00 203S.23R2095.234 tot*tothlAeerlerlI needed 1200.0001200X00 1126.667 21MB.OS221946.052 3965.2583965.256 1000.000 1K1HAL0117141. MQ*M0.1 1079.125 2399531 oilest need 1771.8331771X33 15733491573549 . 28536.30378536303 4770.5734770573 1079.125 MQ;MO: 397Q.OOO 1140.0001COO.OOO 1000.000 Total initialInitial HQs;MOs: 1200.0001200.000 11278071127.000 19E0000019000.050 3970.= Totaltotal MQj:Mets: 27297.00027297.= othersOthers 0.0C60.005 27297.00527297.075 FORTH?FURTHERR CALCUtAttOflSCO.1CtRAVIONS Proposed InHlatAPQInliatAPil 2730027307 prlpavlneasipavine Vol. I Page 749 J APPLICATIONAPPLICATION PORFOR INDIVIDUALI-NDIVIDUAL MANUFACTURINGMANUFACTURING QUOTAQUOTA lequestleaueet ID.XD.(119726[119726 IdoEp')ate SubmittedSubmitted I 01-MAY-1401-MAY-14 fameName ofof BbhIcBasic CIabuClass oror LintList 11 chagiicalChemical (only 11 Parnor DBA-1B3)DRA-16.4) 1RIPAVTNKDRIPAVINE - ,-. - . .a.. . , . IIIII M L Orug Coda Jameblame andand AddressAddress otof RegistrantRecristrabb ..,nassade MOMMETIVNIIMMI9330-0 (b)(4) Juota• ota YearYear 2A2015IS 3.3AHA RegistrationRegistration Numbar|(b)(4);(b)(7)(E)Number Contact jJsrBnnVhVFb ' -X no (b)(6)(b)(6) Itaailail AddAddressrase >b)(4):(b)(6)b)(4).(b)(6) (Phon«Phone HoNo NOTSrVOTEr AllA11 QuantitiesQuantities «t«are eoto InhmampArpraaeedaaaaa d Idin QramoGrano ofof AnbydroueAnhydrous Acid,Acid, BaaBean,ft, oror AlkaloidalkaloLd(not(not asea 9glaceaire> . Cuotau• otae Pi4.vic-.-iJyPrevicuel !iflmdI.au d 3vb PSADEA 2015 Quota Aequo p tod JuataQuota HistoryNiatory 20212013 20142014 2015 Quota Requested 1.000,000.01.000000.0 1,100.0001 100.000.00 0.00.0 1,200,000.01,200,000.0 ltc Preceding Year S3tlratc lor Eacioate Cor Year Production CataData 2nd2nd Precedingpreceding YearYear let PrUCOCUP9 2nar eatfmstr for estimate far Year CurrentCurrent YearYear RequestedRequested InventoryInventory asas ofof DecDec 1131 la1,16i.167 C o.c0.0 0.C0.0 0.(0.. a.a.BulkBulk ControlledControlled Substance/LiarSubstance/List 11 Chemical...Chemical O.C 0-<0. O.C0.t 0.00.0 0.. b.b.In-Proceaelr\-Proc«38 Material..Material 0.(0. 0.00.0 o.c0.0 0.0O.. c.C. containedContained inin FINISHEDFINISHED DosageDosage Forma.Forms 1,167.03.167. 0.00.0 O.C0.0 O.C0.. bisposition1Sale)JispoBiciontSale) /Utilization/Utilization ' 1,200,000,0 640,094,640,094.. 0.00.. 1,200,000.01,200,000. 1,200,000. a .Domeotic, a.00meatic 0.0.. 0.00.0 O.C0.. O.C0.. bb ExportsExports 640,094.640.094.. 0.00.0 1.200,1,200,000.000. . 1,200,1.200.000..000. 0 4cquAcquisition/Production1 a 1 1 lcrj / produc t ion 731,569.731,560.0 0.00.0 1,200,1 200 000.0000 0 1,200,000.01,200,000.. a . Domestic Sources . , a,Domeatic Sources 711,711,560.0S6 9. 0.00.0 1,200,1,200,000.0'000 .0 1,200,1,200,000..000. c reIf ihothe PurpcoePurpone isis toto ManufactureManufacture AnctherAnCther SubstanceSubstanee(81,(si , FurnishForni oh thethe FollowingF01101(11%9 Information:Information: Amp ant Used for tbla Purpose % Yield HiName ofof He*Ma. f}uh«taxve«Monatanes DrugDrug aMpliat limed for thin Pur o • 11 Yield 2012 2013 20152015 Est. Quantity [flat, collation Tiee Product DevalopamntDevelopment DoaageDamage Torntorn j StrengthStrength Unit*Unite/Patch/Hatch tfil of BatchaaBatcham BatchSatoh PurposePµapage Met. Quantity let. Completion ?Lae of Transfer c rranaforTransfer Registrant r ExplanationItavaenetion of Transfer • flatsData of Doatruoticn,Destruction]|_ __ Explanation;.lenotion 4 of Pkga Purpose total Quantity Packaging Product NanaHaan I Strength 1 Onits/PkgOnits/PAg I 0 of Vega Forgone I Total Quantity ItemdtkaRemarks | As there is no specific 3ripavineOripavine mfg quota isId requested tcte convert oripavine,orlpovine to a BuprenorphincDuprenorphine Intermediateintermediate forl(b)(4)for|(b)(4) I As there in no specific 1200 kg drug cede the the Intermediateintermediate quota is being requested for orlpavineoripavine as we have been instructedInstructed in.thein the past,past. 1200 kg reelectsreflects nodeatmodest growth for the product over 2014. . . L i Vol. 1I PagePage 750750 APPLICATION PPRFOR INDIVIDUAL BUOMPACTURINUMANUFACTURING QUOTA Requestequest Ill.1106S0IP.lil86So bate Submitted'Submit tedT 2625-MAR-14-MAR-14 NasMujf_Ba9l.s_ClAte_5i_Iils.t_l_fiblaiA__QIJUM_Qr—taist_l_ChemicalChemical (only(only 11 Deroar DEA-11391DBA- 1691 _- QBJtemajs AchedUlOILidt_HUMbar3.chedule/Llas_Nunihar_ .21 Haasams and AddraaaAddress of RecristrantRegistrant PruePtus Code 9330-0 (b)(4)(b)(4) QuotaBuota YearYaar 2015 PEADBA Registration NumbNumber4b)(4)PX7XE)e rJb)(4):(b)(7)(E) Contact PersonfhlffllPerson (hKBI I Wax.Fax. HoNo (b)(6)bY6) gmailBgtftll Add COSsaeB VhVAIAIVRIfhVAWhVfil II rionefhona No 5032,KOTBi All QUI0titi00Quantltioo areIt) to babe D€pExprapaad d inIn QriupGrans etof AnhydgquiAnhydrous Acl ProductionProduction Data lnd2nd Preceding Year taelot Preceding Year ;intimateEstimate for SatimateSBtiiMte forlor YeazYeas Current Year ReWratadRtqyeat«d QJz- inventory as of Dec 31 253,4134.Cs253,4B4.0j e7 .0 0.0O.C 0.00 . C a.euika. Bulk Controlled Subatanee/Substancc/LiLiot ot I1 Chemical...Chemical.., n c.o 0o,c.6, •jjh.1 .td 6 (....^00.0 0,0o.c 0o.o 0 bb.In-Froseso. In-Pro=C9Q Material 0.0OA 0.0 0.0 D.0D. 0 c. Contained in FINISHED Dosage FormsForms.. 253,484.02S3.4B4 .0 0.0MI 0.6O.C O.C biepos£tion(SaleP/UtilizationJlspoaitionlSalel /Utilization 154.943.0154, 943. ( 0.0 1.131, 300.0poo.c, 1,131,000.01.131,000.0 a.00neetlea.comeatle : 0.0o.c 0.0O.O 0.0o.d 0.0o.o b exportsExport a 154.943.01S4. 943.C 0.&0.0 1.131.000.01, 131, 000. q 1.131.000.01,131, 000.0 Acquisition/Productionftcquia i t i©n/Productian 154,690.0154, 690 0.0 1,111,000.f\lf 131,000.0 1,131,000.01,131, 000.0 a.Domeetica. Domestic SourcesSources.. 154.690.0164 , 690 . 1 0.00,0 1,111,000,61*131- j 000.01 .• 1,111,000.01,131, 000-0 IfIf the Purpose isie tota ManufactureManUfacttre Another substance(s),Substance fa] , Furnish the FollowingPollewing Information;Information Ko»«Nerve ofo t Now SnbetsncoSubotfcfieo Drug ^neuritAmount UaedUsed for tbiathi> ParRurpoac ode 4\ YloLdYield 2012 2013 2015 • 116, 000 K 45.0045. 00 4TDROMORPRONEHYDRONOR PHONE --2.cA.t\a71'..CA72-TY-11(w.!1(! F'P)) 9150-0 0 0 116,000 • '201%0APHONSJXYJ4CRPK0NE (FOR{FOR SALE) 9652-09652 -B 35,05335,051 17,21717,237 166166,, 000000 1✓... , 45.00 r-1.- TiM4 Product oevelepftentDBV0lo{matie Dosage TormFom f seString sorbeh snits/Hatchanita/Bateh 44. of Dutch..Bitobee PatchBotch PurposePurpoD« Roc.Hat. Quantity [Bit.Out. Completion Ti«« Transferrze.UA far Registrant SaplanationExplanation of Transfer Date of Dagen:taloaDestruction I| Raplepatlog_?1,3matio. Packaging Product KoaoMaas Strength [ Vnite/Pkgvai ti/n# I| 0» of Pkgspxa» I| PU99020Furpota I| Total Quantity RoaarkoRemark* ~lauocauota leie for£or supply ofo£ 500SOO Kg totoj(b)(4);(b)(7)(E) tb)(4)(0(7)(E) Egall1(b)(4) hill also use oripavineOripavine for internal conversion to Oxymorphoneymorphono and Ryoromorphone.Hydromorphone . see supporting documentationoocumentation sunmitesuomitceci via email for sales breakdown. • • • , Vol. 1I PagePage 751751 APPLICATIONAPPLICATION FOEFOR INDIVIDUAL MANUFACTURINGMANUFACTURING QUOTAQUOTA Baqugata- est ID,ID.119506[119506 bate•ate SubmitSubmittedtad 29-APS-1429-APR-14 ei uaAJ.es. ) L DRIPAVINE•V . Schedule/List• Number X tame and Addraaa of Bflgjgtgaat. orua coda 9330-0 (b)(4)(b)(7XE)(b)(4);(b)(7)(E) jvjotauota YaarYear 20IS2.15 •RAISA RegistrationRegistration NumberNumb e (b)(4):(b)(7)(E)(b)(4);(b)(7)(E) lontactr...37-4-T4WrIrrrViParson hlffil rax,7, 11.7np 111 (b)(6)(b)(6) Email.:=CliEltPLITTilAddress. ;b)(4);(b)(6)b)(4);(b)(6) [Phono Wo KOISl&OM All Ou.ntitJ."Quantlries «r«are toto bobe Eacoreoood1:sprawled Inin QtaitoGrams ofof Anhydcou.Anh deous Acid Baaa.Base c»•r Alkaloidlkal•i• (notnot «as 8alf?Salts ., gvsotafl Prftviwmty issued by PER •biotn ate HistoryHistory 20132013 2 014 20152015 QuqtaQuota aequoRequestedJ ted 10,400,000.0 10,732,298.010,712,299.0 0.0 19,000,19,000,000,0000 . 0 2ati Diepoeition.ispositionfsaleUptilization(Sale) /Utilization 10,277, 775.0 IMEIMEIEMEo.c MILIE0 .0 15,777,776.0DOWESEIMI LPEEUREE * , Domestic . s.Domeatic o.c0. . 0.0O.. o.cO. . o.cO.. bb Exports.Exports 19,777,776.0 16,777, 776.Q 13EMO.C EIMMIEMDIEWISECIEIIMIIKEKEENECE0.0 "Vcquieltcquisiclon/Productionion/ Production o.c o.o 19,000.19,000,000.0000. C] 19,000.19.000,000.•POQ.O a. Domestic Sources.. 1 .11MILIEMII IIIMX 1 a.Donestic Sources 0.0 19.000,000.01 19.000, 000.0 =1.11M 01.Ec NIIMINWIE 19,000 000.0 19.0001 000.0 Iff thflthe Purpo3«tPurpose iflin to Manufacture AncthorAnother SubstanceSubstanC4(a), \ (( (0(^QoCjsSba0b 693 )\ 1 ) Est. Quantity [Bet, completion Tixo Product Development DotageDosage PoroPorn Strength TinObits/HatchIts /Batch IS of Batches Batch Purpose set. Quantity c transfermeter Registrant Sxplanatrplanatiootlao of transfer ' . DatoDate of DestructionDeorruction I Explanation'Demotion • | Total quantity Packagingackeging Product KaneRamo Strength3t»»n9tb | Onlta/yltaDelte/Pkg | 0< of PkgsFfc3» PurpoeePurpose Total Quantity Renarknrka • 7 L Vol. 1I PagePage 752752 APPLICATION PORFOR INDIVIDUAL MANUFACTURING QUOTA bequestRequest ID.1119630IP. 1X19630 laatebate SubmittedSubmlttedT 0101-MAY-X4-MAY-14 Name'lame ofof, BasicBaalc. ClassClaaa. oror. ListMat. 1X. ChemicaChemical fonivfonlv 1 eeper i)RA-1991DBA-1691 MI1RJLPMIHSMI= —_ pchaduie/LietSchadule/Llet HumberHumbar Z. klamanaa andend ftddraaaneldreaa ofat RortiarrantSaalttant T2IMI)ry ContactContact_P,ers liersoraft)EES II Pax.ax aNoa (b)(6)(b)(6) EmailSma i lAddro Addresso3e VIDW41(b)(6) I Phone'bono NoNo. HOTZiVOTE, All Quantities are to bobe ErprospedSrprqssed inIn OronoQrmi of Anhydrous /cidAcid.er Paso,Base, or AlkaloidAlkeloid(not(not as£i Setts).9elt») QuotasQuota's Previously faeuedIssued by DEADCA Quotaiuota HietoryHistory 10191013 20141014 20153015 Quote RequestedR^yaogtod 3,126,000.01,120. 000.0 3,282,650,03, 263,650,0 0.0 5,151,000.05. 151. 000.0 ProductradUCtiOaloa Data Std2r.d Preceding Year lot Preceding Year &Sti IfIf the Purposepurpose isia coto Manufacture Another Substancele),AubstanceHa) , PurnishFurni3h the Following Information:Information; • HemeName of NewMew Substance Drug AaauntAmount CoedUsed for chicChic FurnoaaPuiyctj tk Yield 2012 Ir 2013 1 2015 WDnOMOnPHONEWOROMORP0ONR 0150-0SISO-O 1.140,2101. 140,220 1,965,400.341. 965.400.34 2,, 06006 0,, 000300 1171..20 ' 43' C.::) r---•-•; A t) g Product DovelopmentDevelopment Dosage PornfrttronvthPora Strength Delta/BatchUnite/Bitch 'a'9 of DetcheaBatches I Batchbatch Purpose I Eat.Get. Quantity Est.Set. Completion TineTina --1 Transfer RegiatrantlRegistrant Explanation oeof Transfer ... DateDote of DestructionDent ruction -1I Explanation . ' PackagingPackaging Product DanaHome 'SStrengthtrength I| Unlta/FkgUnita/Pkg | 4t of PkgoPkge 1 Purpose 1| Total Quantity I C . RemarksKeaarke • - 2.092,0002,B92,OOC grams for conversion to bydromarphone,hydrOmorphone, loss on production estimated at. 1,071,000 grams 1,000 grams for oripaVineoripavine referenceetandards/conversionreference acandardB/convftrslon to hydromcrphonehydromorphono for reference standardsatandards L Vol. 1I Page 753 APPLICATION FOR INDIVIDUALINDIVIDUAL MANUFACTURING!NAMFACTURING QUOTA RequestRequest ID4119606ID. [119606 batefcaato SubmittedSubmit tad"T 30-APR-APR--1414 poleJams of BanjoBasic 'ClassClacii_ar_Lla.t or Lint 1 1 Chemical (only(only 1 urnmar DRnRft-iast -1891 LL ORIMINEQRIPAVINE AramdulniLintlehadul a /Li fl C KUIflilflrNumbsr 2 Name030 and addeadAddteas of RealNaciatfaciatrantmm . Augleug Code ,3330.r09110-0_ (b)(4)(b)(4) Quotafuota FearYear 2015201S DEAIRA Registration NumberNumber(b)(4)PX7XE)(b)(4);(b)(7)(E) ContactTantaet korP.araoaKbKbT )(6) lax.lax. .Ho.flo _ (b)(6)(b)(6) ~mi1gnmil, Add?«ag_|FhW4WhWfi^Address h1(411hVAI >none'hone WoNo. KOTSjVDTS: All DuvetQusotitioo Lige ere«r« to babe' gagfaprwgdaaaaaa inla OrmaGrans of JmhyerotuArdaVdrOda Acid, Baa»,Baal,. or AlkaloidAlkaloldinotfgfltjtf, am sales).ft" It*) — ~ . Quota. Previously issuedIssued bvjPEftby DEA Quotaeta History 203.32013 2014 2915201S quotaQuota RequestedS«4uaat«d 700,000.3700,000.0 612.500.0612. 500.0 0.0 1, ass,000,000.0000.o ProductionProduct lot Data led2nd Preceding fearYear lot1#S Preceding YQ^rYves Estimate for EatlnateRatinsee for Year CUrreetCurrent Year Se Dispositton(Sa1e1/Utilizationlispogitlon (Sale J /Utilization -67.0-67. c 0.0 1,000,000.01,000, 000.0 1,000,000.01,000, 000.0 a.Domeatic..a. Domestic 7.00.0 4.00.0 O.0 . 0 0o.c.0 b Exports b Exports 67.0 0.0t0.0 1,000,000.1,000. 000. c 1.000.000.01,000,000.0 Acquisition/Productiontequi sit ion/ Production 327,581.4327, 581.0 0.q0.0 1,000.900.C\1, ODD, 000. C 1,000,000.0 a.Domestica. Domestic SourcesSources.. 127,501.327, SB 1.0 0.0 1,000,000.01,000, 000. 0 1,000,000.01,000, 000.0 IfIf the Purpose 19Is COto Manufacture Another Subetance(si.Subetance (a) , Furnish the Following Information:Information; HeaaHama of DewWow SubatenceSubntesce Drug. Amount Uacjmad for thinfchia Purposemaroons 'a% YieldVia/d 2012 I___ 20132 013 201S2015 Ouprenorphiseiuprenorphlne baaebase 0000.0000O-C 0 0 500,00050 0 , 000 50.00SO. 00 Ougrenorphinelupreno rphine HC1 0000-0 0 0 500,000 50.00SO.OO Produrt.DevelopmentProduct D*v a lepmant Dosageboaaga Form Strength tJnita/BatchVolts/Batch ilIf etof BatcheaBatches I Batchmatch PurposePurpoee Hat.Hot. Quantity [Eat.Set. CepaletionCompletion TineTito Transferrrenefer RegiatrantPagiatrant I SupExplanationlane tIon of Transferrrantfer DateData of Destructionpaatru stlon | jftlaatciotExplanation rf | Total Quantity lectagingPoCkagihfl Product BaneNona StrengthStrong th TfpltT/PkjUnita/Pkg I 9# of PkgaPkgo PurposePutpoa* Total Quantity ' Seaarkasmacks *altietep.ultistep conversion of Intermediateintermediate purchased from a CFOCMO against procurement quota to Buprenorphine basebaae and euprenorphineBuprenorphine HC1C/ against manufacturing quota. L Vol. 1I PagePage 754754 st ' APPLICATIOHAPPLICATION FORFOR IKBIVIDUALINDIVIDUAL MANUFACTURING21ANQFACTURINO QUOTAQUOTA Re Sant.ac.t-Qontact P.orflonPereon(b)(61fhifRi 'ax.ex. NoNo (b)(6) Smallgmail addressAddress b)(4):(b)(6)b)(4).(b)(6) 'hcnchone MoNo, KOTSxNOTST HIell Qu.ntiti.0Quantities ...are COto baba Bror.B.odexpreeeed Inin qrnaadrama otof AnbydromAnhydrous Acid,Acid, Bn.Bass,*>, oror AlkaloidAlkaloidtnot(nor. meao 9alt«>.SaltO ' Quotasuota(' PrevlouolyPreviouoly Iasugd_byIssued by PEAD2A 2013 2514 2015 Quota. Requested 3uot»Quota BittoryBistory 2013 2014 i, 2015 Quota Requested 0.0 410,000.0430,000.0 0.0 1,000,004.01,000,000.0 R4ciir4(a tar Vear Production DataData 2ndsad PrecedingPreceding X«*rlair 1stOct PrecedingPreceding X«urYear EaCinaCBEstimate if*for RACIV2E0 far rear CurrentCurrant fearYear ReqjeatedRequested inventoryInventory asas of DecDec 3131 O.C0.e 0.0 23,23,000.0500. C 33.000023,000.0 a.a.BulkBulk Controlled Subatance/LtatSubstance/List 1I Chemical...Chemical o.cO. 0.0 o.c0.0 0.0 b.ln-Proeeas Material b.In-Proeeea Material o.cO. 0,0 O.CO. 0,00.0 C,c. Contained in FINISHEDFINISHED Dosage FormsForms O.C0. . 0.0 2323,000.0, 000 . C 2323,000.0OOO.Q Disposicion(8a10/0tilizationDisposition (Sal a) /Utilization O.C0. 0.0 1,403,1,403,000,0000. C 1,403,1,401,000,0000.0 aa.Domestic.Domestic O.C0.0 0.0 O.C0,0 0.0 bb Exports.Exports Ojf0.0 0.00,0 1,403,000,0 1,403,000.0 " tttO the Purpose lato to KaiuiHacCuraVsoofacture AnotherAnther SubstanceSubstance(sI,(s| , FurnishFurnish the Following InformaciotnInformacioot % Tiald llamaNaas otof NowNor SubatftnceSubstance • Drug AmountAmount PacdUsed Corfor thiathis .PurposePurpose t Yield 2012 I 2013 J 20X52025 c«t. Quantity [set. Completion Tina Product Development DoicgiDosage Form Strength Uotte/BfttchOmits/Patch | If0 of Batch**Batches BatobBatch PurpoaePurpose Yat. Ouaotity !Bet. CalaplaLltalt TIM& c Transfertttflfltor Raglfltraat^Registrant Explanationamplanation of Trail*Transferfar • OftDateto of PeptructlvaDestructive! Ixplanatier,Explanation « of Pkga furpoao Total Quantity Packaging Product Nam*Name StrangStrengthth | Pnlte/Pkggaits/Pkg 0 Of Pkgm purpose Total Quantity TT.1-') 1 4N (A. \ Ovv ,N* \. ! V RemoRema^Ko a 303,000gI0 3,000g is planned fortor use in Hydromorphonemydromorphone and 1,3l, Jbd, 0,00DgOOOg is planned forfox use in OXyMOrphone.Oxymorphone . • C Vol. 1I PagePage 755755 e*««eEusic cu*.:Marv: »iU4etA3 20162018Initial lerful APQAPQ Worti*hc«t»Worksllects TflUITotal PCPQ Reqt»*r*d:R Nuevo's.: 55000 000 FQACsl:F OA est: tW3INStit Est Adj Avail Celc UQ Corn poly DgAOP-ANun Nun 2«1fl2010 RequestedRequested WQMO 20142014 fc*r«*dPetssed UQMS 20«is»im2013 Sales 701170%3Oea DEA ufj1.06.41es£*ke* H%n a 22U7313ssUm Sates SMlSeam del TDlfi7016 TotalTotal PQPO 20132013Inventory 'memory 20142014 ProfMttdProjected ExikhIsExports 20142071 ProjectedProjected &ak*Bak. 20120111 Projected Proioctext Export*Expern 20142011P/t^ecWd Projectedhrfnlf>ry h•mtory Adj Avail Cale MO 0.000 fl.OM 6.000 4.DC0 DOM 1.000 O.QCO 4.000 (b)(4);(b)(7)(E)(b)(4) (b)(7)(E) SJ1M3000 00000 000 o.eoo0.000 5.624.337.0005.624.322 000 0.0000.000 0,000 0.000 0 000 4 003 01:00 1.000 0000 4.000 6.15r.KS.OOO 5.63*. 3?2. fXO ocoo ST2.6/S.OOO 0.000 1.403,509 DOC DOM Vlfl1.J20.000 5^47.Ma.WO 1.6CO.DOC.OOO I1.4013,000000AOO.OOOJJOO 6.157.639000 5.Q4.3.22 COO 5i24.322.OCO5$94.322000 10001.000 • 5400 172.679.030 0 000 1402.509000 0900 1.101220000 5347.556900 1.6013,000.000 l,BOa.D05»OO 6,157.633 «0 1iC0.OO4.OOO hiarouH:MO TotOs6 1,600.005000 6,157,639000 1,660,0.04.003 2014F«vlViliM2014 6,341 lelthl APOAPQ: 77,400,000.000400,000000 20U2011 FtoxlFind R+Ai*4R4o1641 *WtAPSt OOOQ0.000 f0AE«t(7aU^«l*lAPa*1FDA Est• (20 14 brillal AP 10 • 1 • FDAFDA En}:Ea*: 7.400.0007.400.010.000000 (M3OASE*t Esc <2014MOM WtUIAPQ*fr 10I APO• 1Se4 IMS1/4 S £z«:Eldi 7.400.DO3D00ZA00001.000 201126119 prapmedPsoposed WUaJAPOrlottu7 APO: fi.WO.OOOOCO6.660000 °CO wifliveal ZSVit-ftfer:25% nude n 6i5a.OCO.OOO6290.000000 0UM4Cow considerations.considerations: tooboltedknd 01o1 historicalhigorial APO.APO. requestedtoque sled MO.MO, Qfonteffittanide VQMO loIn determinedeerrnine avflavy APOAPOI RequestedRequasted MOMO ©ranted&anted MQMO 20102010 S,6CG,000.0005,699,003.390 S.600,003.00®5,000,003000 S.6OO.COO.OC05,600,000.000 20112011 5,200,000.0005,200,000000 5.120.0005.120.000 000000 5.120.000.0M5,120,000.000 20122012 7,600,0000007,600,000.000 e.e.aoa.coo000.000.000 000 7.5427,542,000.000.000.000 20132013 6.200.000.0008,200,000.030 9.003.0000.053,000 000 S.S40.045.0005,840,045.900 20142914 77,400,000.033,400.000.003 7.400.0007.4130.000 000cxr 6.157.639.0006.157.639.900 6.600,000.0005,800,000.000 2.184,0000007.184,000 .000 6.051.936.6006,051,938.830 6.676,645.6006,678,645.600 OXYCODONE (FOR CONVERSION) Vol. I PagePage 756 #mal) rm) BASIC CLASS: 2014 InitialInitial Quota Worksheets Oxycodone (conversion) 9143-A (b)(4)b)(4) Company: Request: • 2000.0 (will change after APQ pub) Current YearYearMQ: MQ: 6157.6 Year end inventory 942.9 Calculations amt needed substance MQ yield oxymorphone (sale) 2462.296 1403.509 0.570 total needed 2462.296 INITIALINITIAL MQs est need 3674.401 MQ: Total InitialInitial MQs: 3700.000 0.005 Total MQs: .3700.005.3700.005 + others =5 3700.005 FURTHER CALCULATIONS Proposed InitialInitial APQ 65806680 used historical avg Vol. I PagePage 757 V1, APPLICATIONAPPLICATION FORFOR INDIVIDUALINDIVIDUAL MANUFACTURINGMANUFACTURING QUOTAQUOTA iequ'eategnent IP.I119S14ID119514 ; batesate SubmittedSubmitted'I 29-APR-1429-APR-14 lamaame gfof a3n contactContact parsonPerim fhwftt(11VRI ax.ax. NoNo (b)(6)DX6) SnailEmail AddraaaAddress b)(4):(b)(6)b)(4) (b)(6) ihonoIle HoNo. HOT*.POT': *11All Quaacitl.*QUabeieise *reate toCo babe n.orti...dRepressed inin Oramdrams otof Xr^A'm,mArdaydrova *f* Qiisposition(sale)/VtilizationBposition isale ) /gtili zat Ion r 1,403 , 509 .0 1,403,509. 0 0J0.0 0.00., 1,403,509.0 1,403,509 aA.Docescie.Doneatlc . . o.o O.C o.o0.0 o.oO.• 0.• 0 bb ExportsExports — . . . 1. 403.5 09 . 0 1,403,509.0 0.CO. O.C-• 1.403.509.0 1.403.509.' \c tyu i s i t i on/ Product 1 on cccitation/Production 1,600. 000 .C 0.C0.' 0.00.' 1,600,000.0 1,600,000 aa.Domentic.Domestic Sources.*SourCee 1,600,000 O.C0., O.C0.. 1,600,000.01,600 000 1,500,000.01.600 000.0 It21 thethe PurposePurpose isis toto ManufactureManufacture AnotherAnother substancela)sunstancels),, FurnishFurnish thethe FollowingPolloving Information*Information: % Yield KaneWant OfOf NewNeu QuhotaneoBubotaneo ' DrugDrug taovntPaaen.utt OBodgeed forfor tbiaChia PucpoaoPurprao S Yield II1 22001212 ) 20132013 I 20152015 57,00 OXYKOHPHOH8OXYNORPNONB (FORWOE SALE)SALE) 9Gf»2-B9652.-21 5,036,6135,836,613 5.933,6005.937.600 1,403,5091,403,509 57.00 • Units/ Batch Batch Purpose Sst. Cuuclty jgQt . completion Tina ProductProduct DaVolopsJontDaveLopaeat DosageDosage ponsFora i Strengthstrength gnite/Bateh t4 ofof Batchesgateau.. Match Purpose Est. Quantity rat. ccaplotlon Sloe c rraaeferrooster BegiRegistrantstrut | ExplanationExplanation ofof TrusterTransfer PatePate of PaPeetructlonstruct ion f faplanatlQPlanatioo • | Total Quantl t/~ PeckaglngPackaging Product t keearkelexnarks . . Vol. I Page 758 n r r 3 I I i n II i! f Ostia CU.*: 914343 2313 1344.1 APO 36/041460eAta5 II a si 2 I 3 i 7001150 Requrattst 20,211,764 100 FDA Est 1 1145 0.4: T * ? i •2 S«a8S8!:<5S » « s I B I ! SftHSjqsiqsSR I |ii!!!!!§! OT « 8 s 8 JJ 8 J 1 B z '"ililMl 8 "st!!!!P a "SSS2SSSES < "anvOotc>o>nO "• i " |§lii|ll!l jg 3 8 s-"3§zlSIS Hoociooooeo 8 5 CA4Dparryr DEA Num 20/114946r0511,10 2012 94.44•40 SAO 70123244>158318111 2013 DEA140 Dates 164,92213 Saks Shored 2011 Too l PQ 2011bryrrtary 2014 Psoiot00 Esp.:As 2014 ProisYss04 0. 4.4" 201"ft :1.. 0 C.F.'114 V"" 4.0..."' 1.14AvAJCAlc 120 $3U33*§S -38531° §?§2§i§s§ M§utlt*s 1 o «1, 55 ' iiihiiii 10.060 5.000 7.520 7400E235 3641 0.000 ' 1.136 2, 00 0 000 5000 0000 1000 5.250 0.1147 «a 8 1 o (b)(4) (b)(7)(E) -1 60.000 60.099 9.624 76,004,231364 0.090 6377 1101106 0020 31.033 0.000 810.606 83.1.103 1559360 s"s'!i ISSSSSs o> " » S 8. - 5335*55 v « •> 1 o 5g||l|« 2 6,421,000 000 1,005,030000 49,1162.000 76,591,255164 0.001 41,152001 22,106000 0000 6423.000000 0.200 28,000.000 1 ,010,003.966 5.441.142000 ¥> - ' I!H! K o 1 w S 8 40 s d 8 2700,000 000 1.266006000 297,105000 14,391255504 0.004 261,233.06 769019030 0700 2,700,000m 0,001 796.721000 1 6158163> 50 1393,431044 R •* R' no' S 3 £ g 8 •- £ — 1 d a 13,030,000030 24.000.009.W — 14,619.041 800 78.531315.684 6.169 11.207156.550 14,101.612070 DA00 15,8106020m 0.000 6,907,225.000 29,726,196,901 11699,121.653 8 r 2 o 5 2 5 8 * S - 1 £ 8 69,202,000030 64,131,406.000 * 433 06010 CCO 79,934256514 0.561 40,136614.441 71,551,160.000 0000 64,401,000 OA 3000 1084000.000 65,463,717.300 46670,047.533 t» £ •» r< ~ 8 8 1 a 2,000030 1,000.003 66.6.357.290 16,191255344 0.011 074,005.701 02,406= 3,300 2.003030 9.000 0.000 70,04103 976.359.175 *i a ^ « * IS 5 W i; s 8 b i § 1 S ^ — » 11.110,606.6,50 24.000.962000 16451966.0062 76.091.255.514 6112 145615.21.054 11,102,045.200 4600,061.000 10,507 .01.4 .000 0200 91517.0:0.074) 25.394.511.700 5019.605142 HQ fiKpninyCore MIUj.0.2A Nowt MIFHsqucitedHO2012 Requested MO MlHwkrtUQ2014 Re'--" M0 J3liraliS»M* Shea M132213 OEAOF.A I4QKO SatrtiSWee to(SnSikit of 2312 9001 ShirtSheerof M2018Ml 8 TotalTore1PC PO 20112013 hwrrrtcrr1.,,crimy 20142014 Pr»i»ctKlPreisstedE*pcjta E.,. Ml*2114 Praj^VrlPicriss.2.elS»Vm Se*, Ml2016E Projected Amoco-15ferport> trp4rts 2Q|l201. PrtfrsOpdPrOiertedk.»«Mf*y hwniewory A4JAerjAv*UC** Ar.i.IC.0 MO 4000 (b)(4);(b)(7)(E)(b)(4) (b)(7)(E) 5I 00CWO 0.0000.000 o.occ017.171 7.M1.7dfl^057.7g1,7.54.65-5 OOCC0,003 0.0000000 9.W00000 0.0000000 4X00&COO CW30 030 1XO01DDO G.00Q0,030 4 500 0000 1,737.631 000 6.639.671 300 11,066.790347 16.9CO.OOO10900000000000 H.MO.OW.flOO11.200.000.002 e.300,508«*6,300,5311022 7,793,748.0007,723,720,020 0.6560339 3,033.123.4770033335.417 1J7J.762.0W1,975,752.003 ooco0000 16.132,103.00010.&12,503.000 0000 1737633000 9.639.621 500 1108290347 fi24.DOO.OOD 7,167,461.730 a,aw.®* 421 4411.000000 51.000 .00 2,6072,607500.000JOO.OOO 1,4631,423,211,211.000020 ?,733,7M1,793,786.000000 0.1920.102 1.162.643.6211,192,643.223 K9.MOOOOn9.680 000 0.0M0000 5\3130000003,000 000 oooo0000 234202030 2,122,191,7SO 3267,004 321 OD00 0000 1,000.000 l.OWOOG1000.000 oooo0000 oooo0.000 ?.7fiJ,?M.OOO7,723,774.000 0.0000.000 oooo0.000 00000.000 OOOO0.0:0 11,000020,000.000 00.000000 0.000 0203 1.000.000 16.626,626 M9 HQMO TeAiU:T eloiai 47.352,006.00017.)22,026 OCC 13.B07.S09.00015207509.000 16.62.10.626 669 M142014 FtwJfctUHIlPQ:Find irstOal 2o.ooo.ooo.ooo20000000000 »142014 r«*-lFew. H*vU*JRwisrel APQ:APO: 0.0000,000 FQAWA Est:Est pai4(2014 knklsiletlel «Q'APO. 1I •• FCFOAA EM]:Et0: 7020,000,000000.COO, DOC .000 IMSius Est:Est (J0l4(T014 hutialAPQ1leirial APO • 11 » IMSIms Est):Esti: 20.tttl.OM.00020,030,000000 Mia201E PropMftdProposed Initialh.M.IAPO:APG: 17.500.00017.500000 000000 «Miwire 7i%36.4 hL*l*r.Wren 31,875.00021205,000 000000 . OXVMOflPHONEOXYMORPHONE (f(FOROR CONVERSION}CONVERSION) Vol. I PagePage 760 1 BASIC CLASS: 2015201S Initialinitial Quota Worksheets Oxymorphone (conversion) 9652-A Company: (b)(4)b)(4) Request: 16900.0 451.0 1.0 Current Year MQ: 11300.0 2607.52607.S 400.0 2013 Year end inventory 1579.01S79.0 269.7 0.0 Calculations amt needed substance MQ yield amt needed substance MQ yield amt needed substance MQ yield noroxymorphone (cony)(conv) 16825.397 10600.000'10600.000- 0.630 451.000 (fo(for (b)(4)b)(4) nal-drugs) 1.000 refrefstds stds noroxymorphone (s(sale) a te) 10.64610.646 6.707 0.630 total needed 16836.043 451.000 1.0001.000 INITIALINITIAL MQs est need 22291.054 945.947 1.2501.250 MQ: Total InitialInitial MQs: 16900.000 451.000 1.000 Total MQs: 17352.00017352.000 + others 17352.00017352.000 FURTHER CALCULATIONS Established InitialInitial APQ 1750017500 oxymorphone (conversion) Vol. I PagePage 761 t APPLICATIONAPPLICATION TORFOR INDIVIDUALINDIVZDDAL MANUFACTURINGMANUFACTURING QUOTA Requestaaqveat ID.tllSS07r(3. 19.507 (batapate Submitted]Submitted, 29 -APR--APR-1414 NameIflgifl ofof BasicFinnic ClannClaim oror LiLietnfc 1 Chemicalchemical (onlylnarjatk,ULU{only 1631 c OXYMOR2HONE_CEORSONYERELOWWVMORPKONE (FOR CONVERSION) Schedule/ListSchBdulo/Tilfif HnmharNumber A0 L 9CS2-A KamamAtle andand AddraaoAddress ofof RealatranhRegistrant jucwi_Cg.deElnlq_Cade : 902-A (b)(4)b)(4) Quotaquota Yea*Year . 201S2015 DEAEA RegistrationRegistration Nixmbetj(b)(4);(b)(7)(E)Rumber(b)(4),(b)(7)(E) Contactlontaot personpereon (b)(6) I ?sm.ax. WO _ (b)(6) *Ail A0dreas (b)(4);(b)(6)(b)(4)(b)(6) Phonehone MoNo ariTH.NOTEle allAll au.gcicl..Quantities «raars to hahelS5RijadEjpraaaod Inin Oraaeaeons ofof AahvW:otuAnhytxotte Acid, a*ac,Sane, oror AlkaloldfrKStalkaloid(not a,se Bales]mate) "" QuotasQuotas PreviouslyPreyioosly IssuedIssued byby PEAAEA 2015 Cuota Requested 3uetaQuote HistoryHistory 22013013 20142014 2015 Quota Requested. 9,400,000.05,400,030.0 11,11,300,0004300,000.0 0,00.0 16,10,000,000.0900,000.0 Eotirncc for Year Productionroduetion Data andand PrecedingPreceding YearVCAl. lotint PrecedingPreceding YearYear EstimateEstimate for!or Estimate for Yceir CurrentCurrent YearYear Revested;invested Inventory aaas otof DecDec 3131 11.579.762. 579 . 762.C. 0.0 739,737,623.0633.0 737,631.0717,631.0 a,e.BulkBulk Controlledcontrolled SubsSubstance/Lieccan ce/ Disc 1 Chemical.,.Chemical._ 0.CO. 0.0 1,000,1,000,000.0000-0 1,000,000.01.000.000.0 b0.1n. In-Proceas-Process Materialmaterial - • 0.0O. 0.0 o.oo.d 0o.o. ( C. containedContained Inin FIHISHEOPINIONED Cosage0osage FormaForms 1,1 579,762.0579 762. 0.0 1,737,6331,737,633.0.0 1,1 737,717,611.0633. < Disposition(sale)/utilizationDUpoa ition (Sale) /Util Lzat i©n 0.0 0.0 16,632,16,832,103.0103 .0 16,16,632,103.0B32, 103 .C a0.0coeetse.Domestic 0.0 o.o0.0 0.00,0 o.c0.0 bb Exports 16.632, 103.0 O.O0.6 O.O0.0 , 16,632,10316,632,103.01.0 16,632,103.0 ACquisition/ProductionAcqu i a 1 1 i on/ Product ton O.C0. 0. 16,900,000.0 16,900,000.0 a.a.DomesticDomestic Sources.Sources . o.c0.c( 0.O. 16,900,16,900,000.0OOO.Q 16,16,900,000.0900, 000.0 If the Purpose is to Manufacture AnotherAnother SubstanceSubacance(s),(s) , Furnish the Following Information;Information: H*s0Name atof HawNev BubsBuhateneftCane e 1 Drug JuaotmtAmount jJjedUaed _totfor cblothin Purpose.Po one »al Yield 2012 J 2013 22015Olfi W0ROXYMORPHONEROBOXYMORPMONE (FOR SALE) 9660-b9662-B 0 0 6.707 61.0063.00 ! productProduct DsvalopoentDevelopment Dosage vetoPorn 1I Btretgthn raogth j otxlta/BatchOnits/Batch I 64 of BstcboeBatchom Batch PurpoflPUtpoela* jI gstrOuabtltysat. Quantity {Est.|Eat. CorgletlonCompletion TinaTiMe . . c Explenatlvu of Transfer "transferTransfer Registranthegietren Explanation of Tranmfer I.- • Dstenote of DestructionDeetructionl| ExplanationEsPlanetion "i Packaging Product NansName StrengthStronger Ij Pulf/PkgUnitm/Pkg j 4I of PkgmFkga I PurpommPurpas a j Total OusPtltyQuantity Remarks • • • c . . • ... Vol. I Page 762762 APPLICATIONAPPLICATION FORFOR INDIVIDUALronivrnuaL MANUFACTURMANUFACTURINGINQ QUOTAQUOTA .*. 01 -MAY- 14 « — (b)(6) Contactcon a reraonXbwmhVB) bX6) 'hone Mo. Pmeil AddrCBH-Address JhVAWhVmh1(111(hVRI I phone lig. NOTENOTE'i AllAll QuatvcitieaQuantities mrmire 10to baba ExprooaadExproosed 1in Orem alof Anhydrou*Anhydrous Acid,Acid B*a*,Base. oror AlkaloidAlkaloid(not(not aaas SaUi)Salta; QuotaBQuotas PreviouslyPreyieuelyisnuedIsauod byby PEADEA aois Quota Requested QuotaJuota Historyeistory 20132011 20142014 1015 Quota Requested 4S1, 000.0 3,3,010,649.0030,649.0 2.607,2,607,509.0SC9-<1 0.00.0 451,000.0 Sotinat© lot eiilindte for Year productionroduction DataDbte 2nd2nd preeedl&gerecedieg YearYear lotlot PrecedingPreceding YearYear Botimate far Estimate for rear CurrentCurrent YearYear aequeitedRequested Inventory as of Dec 11 Inventory as of Oec 31 624,000.0 624, 000, C 269,650,0269.680.0 0.CO.0 624,000.0 624,000 a.a.BulkBulk ControlledControlled SubSubezanceltletusance/List 11 Chemical...Chemical 0.C 0.0O. 00.0. 0 0.00.0‘ 0. b. In* Process Material - Q.C b.In-Proccas Material o.o0. 0.0 0.00.0 O. C.C. ContainedContained Inin FINISHEDFINISHED DoaageDosage FormsPores 260,269 690,600.Oj 0.C0.0 624,624.800.0goo. 0 624,000624.000.C Oisposition(Sale)/Vtilization>i Bpo9ition If thethe PurposePurpose isis toto ManufactureManufacture MotherAnother 3ubatence Bat. Quantity [tat. "Cceoplotloo Tlao ProductProduct DavoiopiuuitDevelopment Cong*0 aaaaa PomPorn StrengthStrength jI UniteVnita/Batch/Batch |f *V ofof BitchowBeecham |I BatchBotch PurpoiaPurpose Est. OusatAry [Eat. Coopletion 'thee fransforTritISCOr RegistrantRegistrant I SaplanatioaExplenstion of TcenaferTransfer • DateDat ofet PwattuctloaTDestructionT— EglroaUgflExplanation . . • .r • Purpoao Total Quantity 2Packaging0eCkaging Product N&n©Mama Strength [riTTCte/PkgUnite /Pkg | f* of Hg»Pkg. f Purp000 I T9tal Quantity Roaarkoemark° [ProductionProduction lose estimated at 2,000 gratnagrams 1,000 grams to support reference standard business c Vol. I Page 763 r r r O 4 0.ya/0/01I , 3,0 il|s-S* i |!!IW |3I8 jppr S 1019 0001.1 ill 2214 Qm.la 0./9,1 112.0 030.• 5 /919.15 2 a 3119 41111 P8C/A0A PNC7•60/3 0 5,211 9,100 /%57 1 •sJlii ism f ? $1Inl 3/03,37N/33n. Cm,. g 01 11 72/1 IS.N./: 1.2311 .1, 54r3`.no 4/rVV I 050 OV,Tokr•V COW,Srl non 1393.33, 9o31 IN% 1095 -511 01/.3orphter Cu/Know1 s 1.23, 0/3309 Con//cr3/430,-339.37 33/1 15 421 611 `01/53noffnwer33 Cc.330/0/93 0.-3.13.7.330/ CtfArIKICA 161 94 j 3,5110 35//3/1.304/as, Sec 975 Oeynaxplwre Salo 1 Os, / haw Salt Onecl.319,su 0 0 0 Onrstrorph.unr Solo loons, 0 fjl=c= fjjS-5 W/nS S3, 03 Cons., Adet01.no, JH C4nr./51 & SS*1 ii«! H i liii I 7011 01471114/593etary C.1.r.L4114.64 Qum. Cram., NO OTOS 140/3•NryCnka1.1k...4 Q.44 7013 End./ ...mar. 111 511 2011 F./3/1112 1.17..3/3 II 7.11.1 le e41.1c u/s/c/1/1 7 1 ne/1/91001031manonal 1013 Ara/Lank Lod. las. 711 311 2074 Ao/11Ante EneL 110 S 1 ? I 3 10/4 0,91 c ./. 831 975 7015 A.91 (2,51/ 3,5110 7114 7X-3-2.45, .911Q....4(3.1 ..../44,931 /0 33334:ncr3) 0 1 111 ' 1011 Otrivattexa 2015177/ispan, rro 1 s- 5.131 591 511 S/1.G 1,777 3 1 11,9513 Procesn321oasol (411.17 15119 225 Prnocolnle121 til Loa.% S'abels/126In,tiors 314 §3 si i! H il Sf 2114 Eedie/ 193.3.1.• 115 14/1 1015 Cochni Fr/melon al C5034/1431 lo% 1(4an0/3 240% 71.4% Coaver6/0 so % 11.4% Jsgas fsSSS Ity,11//44 ills 35;3 LEti 0.... 53 II si as} 23 53 I! '3/111.2103/.4,31sro 335 $111 ELI Dols. l/ont 591 2 1 iL 593 10150.0 1.10953+ ones 1,111 5* *•= 970 ciLL. 1731 A/efile I I ? § s I § 1 f.o% 1.,60.0f, I 140 .-5014 LP1.11.t, 416a.sor. 147 |j|s-5 T 3i7j0.1|||s-s 5/370. 3 ljs-s Addia./...41 !S*I ilj! 0•42.-.1 s ?«M I Ctrreal nil l"l - i 10110:40 7/0/01.03C41n/1•11.5ea (Z.. G.nel 7015 CO //1.1 In. /.4.1-3 0.1.1.110a; 4.:4. 7013 1..enitrycott9S 111 017 2011 7.....lrft1/5/23/rt 689 Non3 u.1.3,7c m.0331/1 I I IN:m .4301V nuurt a/ 0 201] A..114114» Cad. Car. 199 761 7114 AV .frah.tr End. la, al ? § 5 j| S®i 1 is V iii 3114 AA Quols 7.000 2,095 7010 1.11 (2113g. 1 I 2 ils 5 /not 101/ iloo31,3//3/0t Quot9 mauled /3 mown ) 67/ i 1 I Si ±0 IOLSInsp.../nions 5 1014 239 U003 ? 3 5 :1 tilts r* Silt" 1 000 1,9119 j '•a| 54 II \\n jH" .10.333.1 421: '§3 is! /3.17.331 Prvesen9 leHno 113' 1 1101 I.,li! 9/13143951,/./....y 133.33-.41.413k 49 /19 R.3 15,917 1 no {7 /3 (TT o ?! M il M f C.341.,1.3 //sun 01.8.4 24 201/ 1,009 6n 2011 1 ,A1•10107 C.000//34911.4 % VOsew.d 77.110 41.00'. C.c. trsnl m 11/ V.L331 59,1% ^isla j i- lias? 10.• aaji as 8 :: ?! II MC fill 201] T.7119.203icra 1 416 8 2011E. 1)S20111:1031 I! 0903,000130 2011 CO 1)..f,ti1 RN 511 2011E, 1,018 * Eg 1.050 8 33/mrarc cnrs 1,5002 I I s ! I SO% 11.1e0103y A.1979/11.43I 751 50%. Irnealory A11/5/44.3. 5n jljlj i I | E971151.ATC ON R.E131.6231111C U ill! g mj I 2 ll- e: WAIL 2015OunoCalc p ACTUAL TO DATE Q7117/EA LAS E ^Jl Hi 1A'1111 LNC13 Js gl! pi I* b It < f'r j I . 1.0/./si NO aatgort /77153A0A /4•14..r/nn Notostin0 CPS..40A Prom/ N. 3/03p4/1 1:75-1/04/ il J ei ss 6 jl a s a'; ii - Tore/ 1/12171 34/3/.0 Ing.01 13 Sup MWC 30 .1.2 i D.L111,11.411 3 $5.14 11135C 911110 Do...ri;33. Yield MWC orsor 1opul MK' C & ! I i I I I 1 o a * f I 02 0% 1 11111 050 LVS/A0An. Cnn.083139/31313unefrl'on.rnon 0 694% 1_0117 0 1701 111117 ._ 1//01 ,,,7/ 1 0111 ,311) CI'S- AC,* 1.1 01.4t OHRYPI*011. I'M 1,411,3/.33 610 j j a. si ^ 3 i 53 ^ 11 -t ?: I ss i I : 3 §5 i gg S§ II I * 5 to 0032 I LmrSar 419 71 651 10110 ' 104 795 1 ni NI , 077 1, 0 10111 94 0/7%-A0A ...] folk Os3 /....3/4./.3.. ro Ur 1 027 710% 1 0131 1 900 _ C9SACIA OX,..11therK »• 9.067 419 02011 1.111 "II TOTAL C-110.AlJA TOTAL CPS/AVA ij Cale |! 2011(70=r3/ f! 3 i J rf % j! WrIMATE ONItELLSAINT4C Input lo Tow,. /11.1 0,1.61 Co.£ by S Uj •j s ? 1 S |F ACTUAL /RAIZ 10 DATE QL'OTA WTT11171C127.ASE 0/....3.1.3 50ep 1100 13119C af Asp 913p jl j| |f * P 1* If laps: /// Trec..4 19393.3,390.11 L. 6% Tlepet 0.3.70311 et Una Iny £S2_5S i I Jl 34 0311143.1 2 ii i i Mi Is S 6 » E 177,3,3,sc. sd.? 52.41.1 13/37/0 3.1 //j .14. .9.4p Ng. 1... 95 .4p 1.93' 20. 5142 Slop 41.2 &:13ymorpb..../...C..,rsion s * ; 52 Oe.yerarp i 4.4 F3. C.//r.rz le. COSS to CON!) 010 91 SO. 1111100 4 ,, {27 4 ~ l I .. a is 5 • . 2 n CO1,1 co COMA1 9' 93.5% 1000' 0 0 10010 2,074 I 1111 III N 1.11%77 7 To1..1 12/ .13/91 0 02i 3 j. i lllh 4 M • USA, 111! si=§ 0.117.64..4 For SIP* £S££ = ~g~ Ills 2 3 1||2 Osysserp5/4•4 Tar Salo COM 0[1391 7,500 915% 3 1.121_1 },S90 IU\ 90 -use S 0, SsSS ISHS agi£ Ss3S 'Mil Sg|° 5SSS lill = ' u \- CO 913% 1 1217 /01 5 572 003.011. rC 41 7190 65 Or. 000n= tcx1 .1..:N) ! 0/21/91 193. 591 15 4.1 97 2 2 22 ?• u 11131 i 712% : 17131 ,1:0/.01 le 1973.1 101 610% 0 0910 tit 371 191 141 17.101 4- 97 53 L.11 O LSW .0Nal 2.101 1 1211 I3. I C 1,701 99101 10007 I AM .71. POM k/01.01 710 71.2% 1 1111 07. .201/ 111 281 /4/11 96 .11, I I- 09.0111 O = = OMIT FO 0 90 2% 1 000.3 0 7 781 et . / 1 16 45 III TAW , 1' . 121 t ! | '1'..J (I111 OW) (-"1 A 5 3 I s b)(4) I C0611dent141 4/1012014 Page 1 h- CL CD ^r Vol. I Page03 OJ WZ V.«s EIS CharmCcrmf Alid1AtfdJ,1004iflood t],,-,-,,, Qirral »1< tT9-Q«lp».£x 1014 C.T5., Corlpo.ime Frila>«B**r?_Cj*fi>lHo«, enion Cafic-41411m. c..4.14 GnatCi it 1013 C7S-0 rip. v.( •• So yvatbr‘ C•Soll.1., • M» CTS-Oiip«»»— IaT»qt*r» OkntM*"" _ Q,.../ 70111ft 1 1 EndangEr-in* ln.mr"Yluxy'fY ;5R7J* 731 2nla Enclin. It..attest, 1.M »1 jl> 1 4 Surfing b*oM.y ]VA 144.6 ....1,n1.0c ram.,ii 0ll IIII N., salo5Sc :mem.% n hfc«i mlnble maifflll f> 7011Acsilabd.7011 4vil»M. fo,l1,,,,.todL lav. /{A7M TM Snit AVallabl. I L . V.. ?ttn*i dUiJ. Lad, to* afljf 10117011 API*Fi(>a» Qum. 5.317 8,11/1MHO 1 s.»? 20ISaOISAFIQm» 1421 QUA. 3 111 :014J1H Onpas.....:Pupps****'- »,ng_ 2011}0iiDill...bur: Kwgigg; Marynr.M«gjigfa£gi>gigi k , Ctwr,urn. on r - 1,110 1,190 1,..Motphmp.21.., kr(a Cumw.n. . Oyvirc.plyer,CKsmnpSo— fr.4ft*..:nns,,.'ifiwni,,,,"> lad I } n41 >,04 I vwi 0‘Osyrwurfxy:,./nrsph.n. fm'fr»C< Cowman, &EU ChnnwpIvnc fr. Safe 1111 1„my 640 llil Ml 0,17,,,,Im 44 S.1c 4.27 gSSgtf!" S*1* AHL 301301 I 4fesainiEolict Imv-mi.nr 1#7./I>M 1,411 ..4,14. liii 10132015K»dl> Cs 14.*il»r« 1,374 C4a..re..4CwiWi i•u %•*. V.•4.1.1v«.w«i An:41V, 171.1m: Coors rtsa t. V. Yt...... 21% CMKffWt.£ Vr ^trW (b)(4)(b)(4) l^fpfldrntMl.rdidentoal 4 /1I1hO1a page 2 k 4/iafroi* Pa*«2 Vol. I PagePage 765 APPLICATIONAPPLICATION FORFOR INDIVIDUALINDIVIDUAL MANDFACTORIHOMANUFACTURING QUOTAQUOTA HoquoBtOIii7f;WIEE57111970010, IX 19790 jPatoate SubmittedSubmitted 02 -MAY--MAY-la Namlaae of Panic CIbbb or Lint-. I ghwnleal (only 1 par PEA--189) p9) L 3XVHORarMORPHONE_IMEPHONE (PQR CONVERSIONCOMIEVaD3 g/-fcadulft/r/i.Hachedule/Liatt MumbecNumber JL0 Hmb',an andand Addresa gfof Ryqletr.entRealetrent - „ Area)l*ug CodeCode 96529652-A-A ;I:0(4) Quotaquota YearYear 2P4S2015 dbaDEA RogloctationRegistration Number|(b)(4);(b)(7)(E)Numbe bY4)0X7XE) ) Cvntacfe Paraon Mi]loW61 ax.fix PoNo !b)(6)bX6) Phone'hona HoNo. SP—Ail Address :b)(4);(b)(6)b)(4),(0(6) 1 • NOT*VOTE'r AllAil QuantitioaQuantities «r«are loto b«be gyproaaedExpressed inis qrana_otOVA,. of Anhydrouaanhydrous Acld._BaBw,aoid,__liese. Ctor AlkaloidAlteloiefnot[not mmea galta),.Salts) ' QuaeQuotasaa_Prcvi Previouslyquo ly IssuedIssued bvby PEADEA Quota Raijueotad QuotaQuota. HistoryHistory ' _ 20132013 20142014" 2D1S21115 Quote Requested • 0.0 C0.0.0 5-00.0 1,000.0 lac Preceding Tew ?atimuts for Cetiavco for Tear Production DataData 2ndInd PrecedingPreceding Vcar'fear let Preceding Year ratLaate Ler Patience for rear CurrentCurrent YaarYear Requestedarqueeted Inventory as oEof Dec 31 0.00,0 0-00.0 o.0.1 _ 0,Co.o a.a.BulkBulk Controlled Substance/Substance/ListList 1 Chemical...chemical 0.0 0.0 0.PAN, O.C0.0 b. In-Process Material . o.c b.In-Proceae materiel 0.0 0.0 0.0.0 0.0 c. Contained in FINISHEDFINISHED Dosage FormsForms 0.0 0,00.0 o0.. 1:1 0J0.01 DispositionlSale)/Utilizationdisposition (Sale) /Ut Llizatign 1,000. 0, O.tf0.0 1,000.0 1,000.0.I a.a.DomesticDomestic 0.1 0. 0.0oil 0.30. ... o.c b Exports b Exports 0 . Q-3o.k 1,000.01,000,0 1,000.0 Acquisition/Acquisition/ProductionProduct ion O.Co.4 0.0o.1 1,000.01000.oi 1,000-01000.y a.e.DonesticDomestic Sources..Sources o.oo.c( o.c0.4 1,000.01,000.oi 1,000.0hoot. ifIf chathe Purpose isfa to Manufacture Another SubstanceSubstancefe),la) , Furnish the Following mfInformation;ornation; \ Yield NobsKane Ofof NowNew Substance Drug AmountAmount Uaadgeed for thlathis PurpoaaPurple. I % Yield 2012 f 20132023 1 22015015 Product DavalopsantDevelop:mat PoaagsDosage FunsPorn f StraogthStrength UnitAnita/Batcha /Batch I4 coft Batch**batches HatchBatch PurpoaoPurpose BatEat.. Quantity |S»t.Zit. CompletionConplation IlnaTins • Transferrrannfor ftsglatrtntRegiotrent Explanation of TTransfercons far PatsDate 9tof PoatructlonlDestruction SaplaantlonExplanation _ . • | Total Quantity PeekagingPackaging Product Has*Nana T strength JI Phitp/PAgunite/PAP I« of Pkgs I PurposePurpoas I Total Quantity R«oaarko=arbor to support reference etandardestandards business • L Vol. I Page 766766 J J J ' I I Ou10 C140: 66510S 2013I O Ini114115P12?. S 5 WorksheetsI oN) S 1 T►w-S PO s? 11e4e44140:s SI 9348.441.070I FDA Est IM2 SI Est ,040I. r S n 3 I § I 8 8 •M i 5 -< 3 8 (? S. MO a _. s <* r I U I I P004004 249443 2014 en:odes kreammey Adj Ara p s i I «* 1 1 3 314 elei.eses Exports 2014 Preteek4 3410 2015 Coe I Rxri►d Uwe .02013700 PO 2013 kesetay 2, cors0467I DEK Nem ta I gReamud Ma 2014 00 1013 3.144 2013 210A 02 S4144 "A of 41113 11810 a u 8 O § 0243 5.000 0.003 0.000 3.601.592.0711 --I 0000 0.000 000? 0.000 4030 0.000 1000 3.753 5S X (b)(4);(b)(7)(E) "J § 2773.03 u "8 ~ - t» 236264 206 901 60.000 40.000 4011 30013921 073 0003 3009 215.866 0.000 10000 0070 - V v a 5 J* 8 i »J 1 49303.420 l» f p I 2300.00 123011.500 10000.000 10.000.030w 4020.003„ te 3004502 0/1 0.303 6.143.008 29682003 0.000 104.000.000 0.000 t p {- c §13 3 •! 1 8 s = d 637,142000 433069673 - H 285,541.003 719000.000 611 ASSAM 410.613S S 000 3/604492.0111 0,115 384,009,739 211,211.000 0 000 623,000.000 0.000 -« 5 S i in - 'S > 937,393123 ^ 1 473030000 2,907,231.793 w !!{ o g 2 S 0.000 507,000.000 2010346.000 2002050000§ 3034,0020111 0.177 2001,07.700I 1032391023 0.000 944.061000 »• « - .1* 'a ^ 6 14019 366 s 3 20462.118 u £ S l« 1 0000 0000 3000.000 aocooto 41030.660 3.044.5921111f 0012 30.977067 34030.700 0000 3.000.000 kl 5 8 l> 601.3703168 'u U OQOoppOj* > u o m 387000.000 03,477.250 6 8 8SS3SS.Sij DOODOflOg- »j 1 0000 3.301000.000 003134030 330.405.000i 36011 ,597071 0.092 306025.454 510,730.000 0.000 1,277.000.000 3 — £3SS5SSo SSI'S 3 IIillHi 5 O lllllllii h liiiio'ituiauD r>nao6eooC Iglllllil u g ooooooaov 11888811 ililiin, 370,071 000 171004058 iiiiliils u 8 0 81=35111* - S3lSSiv®8 U 275,630.003 ililiin! 25 o .. s «tiaoC>l*o»5?S- iiiiig^if .8 b •i s 1020,000.000 210,000.000IttllSts.i 0,39 000 3604.597.0711 0.002 7017.645 795,121.000 0.000 610293000 0.660 2 r* s '2 2311079.111V » I «> g 1 MOg ToOls: 6,105.063,000 40.36065.000"5 2014| RAO 606414,0; 620000000001 1 20142 rma1Reeked Apo: 0.600 » FDAg Elk 0 00 30114 APO • 1► FDA 60: 6200,000000 £l l«i" 81 00g Est 00141,0601IIS! APO' 1. VAS Esq: Is 0.« 406040220011 ill , l 5 2 £ OXYMCOMONEa § O m (MR SALE! -a ""-J -si 0) CD O) Vol. I PageCO 767 Basta Cu.: elaal 1016201* InitialInitial APQAPO Wortc*he«tiWorksheets Total POPQffaqiMtlvd: Pa oattoO: 0.000 FDAPDA Est:Em: ihl9IV9 Eat:EM: Corroatty.Ca/rpriy (MAKS:paOEAKtm 20120155 Mectuuted»!«d MOIrtQ W1440141,140sed MOHQ 2013234784.4;&**• 201320100E.*OEA MelHQ SloeSal*» M012071561.%of201JS*lr, 504r4 of 3012013S TolalTo1.41P10PQ 20132011 Irmabiv*o*oftf meg NU»14 Projected ExportsElfportf 2D142014 ProjectedPrejaetJd 54144 20t52013 ProjectedP*aJ»cUsi upon::L"fpOft4 2014 PsoldeteaurvemoryPlo(a«l«l Mrtrtlory AtfJAdJ AvailAvel GUCall MetNQ (b)(4);(b)(7)(E)(b)(4)|(b)(7)(E) 2.0002.030 2.000 oooo0.000 00000.060 0002oooo 0.000.000 0400oooo 0.000 05M0.503 oooo0.000 1S00USM 1.5001.M0 ISCO14» IO2W1 Touts:Totals: 2.0002000 2COO2060 15001 500 2014 Finalfinal 1041410PC:InrtitlAPO: 22,020000 10142014 Flfln-lMI BarbedR««fe«d APO: C.OOC0.000 IVAEDA Eat:EM: 12014(2014 lattfat AMAPO * 1 • « FOAfOA Egli:Ekl): 2.0002.0011 11i1ins EatE«t 12011(2014 InitialInhklAPG* APO° 1 • « ilt4l¥S EstkE*lfc 2.0002.01 RACEMETHORPRACE METHORP HAN Vol. I PagePage 768 r r o 3 i a I 5 o s 2 u | h Sails ttiss:.. 473gt 2016 Initial APO Via itaheala §3 u 52 I » t 8 EC Total PO iteausstad:i 2,317,676 FOA Est A s WS Est .035 svP 2 ill = ^ HP 5 a fill 8 flit i 1 8 I | ? sill 2 w I 3 a a s t; r 5 Sill S 5 rr ! i ! l a | i Sill I I n ;P§ a Ills | €§11 I S R I | I z CompanyV, DEA tarn 20 Sltequattsd HO 2014 Revissd HO 2013 Salts 2012 °Ea 440 sous % 01 l0i0 saws stirs 072013Yosal Pa 201210.010N 2014 Projected Es pans 2014 Projaded Sates 2013 Projeciad Espana 2014 Pm/Wad Inventory MI alel 0 C,ats ill o n HO ° lu a "It -II a g 4000 r- 5,000 3.000 0000 0E53 0000 0.00:1 0000 1.000 o 0,000 " T 4.000 0000 a si 1750 a (b)(4);(b)(7)(E) — a § a S o f» unto 1020.000 0.000 0.633 0000 2,723.000 1020.000 a 0.000 2.723 033 • 1 2121.000 0000 o 0000 3,407250 — a § o i o B 1.000.000 5,163000 mow 0.053 0000 0.000 mow 0.000 500.000 MOW 5,000000 073.750 Easoco 8 I fJ 2 i 5 a i 8 s Ma ! TOWS: 2.423.020 2,040000 3,3172000 5 His S s-s8 ""8 §811 1. PIS - Gk 310 5°a? 888 " i 6 1.000.000 i°5S 1.000.000 404.700 21231.700 =DM . 0630 200 § (b)(4) (b)(7)(E) 0.130 106624.033 611470 0.000 d 8 000 3.378.050 1000000 <5 I i I 2.000 2.000 0.000 2031.700 1.500 I 0.000 0.000% 0.000 0.000 3 0500 . o 0.000§ 1.500 ^ ^ 2.000 o * § 88 700.000 650.000 251.000 2631.700 0.096 J 74224617 5 548 000 o 00001 366000 « 3 700,000 127.000i 0000 362.750 1 o S n X. 8 2.500000 2618.600 2246.000 2.031.700 0.756 3173,400.91:0 2.220000 1,600.000 2174.000 0000 1,709.000 3,331500 2.300.000 | 1 1 i | § 3 1 . MCI Totals: 4,202000 3666.000 4,302.000 111! III! « 188 Ills illl r?.s. 2014 Final Irt1tis1APO: 5004.000 2014 Final FfirvIsad APO: 0.000 •4 If Is FDA Est: (3 014 1nIt(al APO • 14 FOA Est): 5.004,000 W n 8 WS Est: (2014 1011141 APQ • 1• 142S Ea): 0.745026 r> «! 5 ui ? SUF NTAN31. ^ h- o CL Vol. I Page03 O) CD 770 tUa*6a.0,0 CUts;Clots: 117101740-0 2015 1hi 11illi1.1I APQAPO 1Nolubcot•WorMtMtl Y MaWO Totolt:Tee•Ic 9,104,C16DC09,101410000 2.305.7312.303731.000MO 17,190,92.121617,118,9232*8 IOU»i4 finalF Oaf m«4ilAPo:terial APO: 14.000,000=14.000,006 O00 2014 finalFinal R»tIm4APQ:Rov11401lP12: COOD0003 fFDADA EarE«e {201402014 WlUI5511.0.111P0*PQ '• 1 • KAf€A Estl:B»0 : 11,000.00000014,600.000 00ft 1KBTIES. Eat (MM(2094 Wti-Iinnai APOAPO'* 1 • IUSUtt EHVEstv 14,000.00000014,000.000 oca 301lamsa Prop..]Pnpotri InfcUl101.0.1APO:APQ: 10.00090010.OM.000 Ma000 *«hafi*byiT»roath 16% bvrtor. 1lfl00,000000f 2,600,000 000 TAPENTAOOLTAP ENTADOL Vol. I PagePage 771 r r r 1 I 3 2 8 Jl rusk Clams: i, 91334 • 1012 init15 APQ WOrkill•lett it ss § I S Tett( PC 5 100 110 001 10A Est 1442 C.0 ' rs*5im i f I rrtuii « ] 3 I ^dOoacaaao f 2 3 j r. S82S55g3S rrU'j? - SSI i I | S T | 3 t i*i«isu« I . 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Q_ V • SectionSection 306(a)306(a) ofof thethe ControlledControlled SubstancesSubstances ActAct (CSA)(CSA) requiresrequires thethe AttorneyAttorney GeneralGeneral toto establishestablish L,, limitslimits onon thethe productionproduction ofof eacheach basicbasic classclass ofof scheduleschedule I Iandand IIII controlledcontrolled substancessubstances and for the list and for the list I Ichemicalschemicals ephedrine,ephedrine, pseudoephedrine,pseudoephedrine, andand phenylpropanolamine.phenylpropanolamine. ThisThis responsibilityresponsibility hashas sincesince beenbeen delegateddelegated toto thethe AdministratorAdministrator ofof thethe DrugDrug EnforcementEnforcement AdministrationAdministration (DEA),(DEA), whowho hashas redelegatedredelegated toto thethe DeputyDeputy Administrator,Administrator. ' •• TheThe attachedattached FederalFederal RegisterRegister notice,notice, preparedprepared forfor youryour signature,signature, proposesproposes toto establishestablish calendarcalendar yearyear 2015201 5 aggregateaggregate productionproduction quotasquotas (APQ)(APQ) forfor eacheach basicbasic classclass ofof scheduleschedule II andand IIII controlledcontrolled substancessubstances andand assessmentassessment ofof annualannual needsneeds (AAN)(AAN) forfor thethe listlist II chemicalschemicals ephedrine,ephedrine, phenylpropanolamine,phenylpropanolamine, andand pseudoephedrinepseudoephedrine forfor whichwhich thethe UnitedUnited StatesStates hashas medical,medical, scientific,scientific, industrial,industrial, export,export, andand reservereserve stockstock requirements.requirements. •• AsAs statedstated inin thethe 2013201 3 FederalFederal RegisterRegister NoticesNotices DEADEA continuescontinues toto addadd anan additionaladditional 25%25% toto thethe APQAPQ forfor scheduleschedule IIII substancessubstances andand scheduleschedule II substancessubstances thatthat areare usedused toto produceproduce drugsdrugs thatthat havehave aa medicalmedical needneed (specifically,(specifically, GHBGHB andand tetrahydrocannabinols)tetrahydrocannabinols) inin anan efforteffort toto preventprevent potentialpotential drugdrug shortageshortage issues.issues. •• TheThe FederalFederal DrugDrug AdministrationAdministration (FDA)(FDA) hashas notnot yetyet respondedresponded toto DEA'sDEA's annualannual letter,letter, sentsent onon FebruaryFebruary 18,18, 2014,2014, whichwhich requestsrequests informationinformation onon new,new, continuing,continuing, andand discontinueddiscontinued drugdrug productsproducts containingcontaining scheduleschedule IIII substances,substances. Therefore,Therefore, thisthis informationinformation couldcould notnot bebe consideredconsidered inin thethe analysisanalysis forfor thethe currentcurrent proposedproposed adjustmentsadjustments Le AnAn expeditedexpedited reviewreview andand publicationpublication isis requestedrequested toto ensureensure anan uninterrupteduninterrupted supplysupply ofof scheduleschedule II andand IIII controlledcontrolled substancessubstances andand thethe listlist I1 chemicalschemicals ephedrine,ephedrine, phenylpropanolamine,phenylpropanolamine, andand pseudoephedrinepseudoephedrine forfor medical,medical, scientific,scientific, industrial,industrial, andand exportexport requirementsrequirements ofof thethe U.S.U.S. •• theThe followingfollowing pointspoints provideprovide briefbrief explanationsexplanations forfor somesome ofof thethe proposedproposed AANAAN && APQAPQ values:values; ScheduleSchedule II substancessubstances •• TheThe APQAPQ forfor betamethadolbetamethadol isis proposedproposed asas anan increaseincrease fromfrom zerozero forfor 2014,20 14, basedbased onon oneone registrantregistrant applicationapplication receivedreceived asas ofof MayMay 21,21, 2014.2014. ApplicationsApplications cancan bebe receivedreceived throughoutthroughout thethe yearyear andand thosethose receivedreceived duringduring thethe commentcomment periodperiod willwill bebe consideredconsidered atat thatthat time.time. •• TheThe APQAPQ forfor morphinemorphine-n-oxide-n-oxide isis proposedproposed asas anan increaseincrease fromfrom 2014.2014. TheThe changechange isis basedbased onon receivingreceiving requestsrequests fromfrom bulkbulk manufacturersmanufacturers forfor thisthis substance.substance. TheThe manufacturingmanufacturing ofof thisthis substancesubstance willwill bebe usedused forfor analyticalanalytical standards,standards, reference,reference, andand researchresearch material.material. •• TheThe APQAPQ forfor marihuanamarihuana isis proposedasproposed as aa decreasedecrease fromfrom 2014,2014, but not zero hecomse-to accommodate aa bulkbulk manufacturermanufacturer withwith anewa "new synthesissynthesis routeroute forfor manufacturingmanufacturing APIAPI forfor dronabinol.dronabinol. •* TheThe APQAPQ forfor tetrahydrocannabinolstetrahydrocannabinols isis proposedproposed asas anan increaseincrease fromfrom 20142014 toto accommodateaccommodate aa newnew bulk manufacturermanufacturer thatthat will supplysupply dosagedosage formform manufacturers conductingconducting product developmentdevelopment effortsefforts toto formulateformulate FDA approvedapproved genericsgenerics toto dronabinol.dronabinol. LL OD/ODQ/ODEQOD/ODQ/ODEQ 6/4/146/4/14 Page -1- 1 -- ofof 22 Vol. I Page 773 Schedule II substances The APQs for amobarbital, dihydrocodeine,dihydroeodeine, diphenoxylate, ecgonine, levorphanol, and opium (tincture) are proposed as increases to accommodate changes in registrant requirements and L • domestic market demands. • The APQs for amphetamine (for conversion) and lisdexamfetamine are proposed to accommodate increased registrants' requirements based on brand holder exporting to new markets overseas and changes in domestic market demands. . • The APQs for oripavine and noroxymorphone (for sale) are proposed as increases to accommodate the change in synthesis and growing domestic demand for nal-drugs, and specifically Narcan, by legislators, police, and paramedics in states with rising heroin deaths. • The APQs for amphetamine (for sale), codeine (for conversion), hydromorpbone,hydromorphone, methadone intermediate, methamphetaminc,methamphetamine, methylphenidate, nabilone, oxycodone (for conversion), oxycodone (for sale), oxymorphoneoxymorphonc (for conversion), phenylacetone, tapentadol, and thebainethebainc were proposed as decreases from 2014 based on registrant applications received as of May 21, 2014. • Applications can be received throughout the year and those received during the comment period will be considered at that time. List I Chemicals • The AAN for ephedrine (for conversion) is proposed as a decrease from 2014 based on registrant applications received as of May 21, 2014. Applications can be received throughout the year and L those received during the comment period will be considered at that time. L • •« The AAN for phenylpropanolamincphenylpropanolamine (for sale) and pseudoephedrine (for conversion) were proposed based on registrant applications received as of May 21, 2014. Applications can be received throughout the year and those received during the comment period will be considered at that time. OD/ODQ/ODEQ 6/4/14 Page - 2 - of 2 Vol. I Page 774 BILLING CODE 4410-09-P DEPARTMENT OF JUSTICE Drug Enforcement Administration [Docket[Docket No. DEA-3931DEA-393] Proposed Aggregate Production Quotas for Schedule I and II Controlled Substances and Assessment of Annual Needs for the List I Chemicals Ephedrine, Pseudoephedrine, and Phenylpropanolamine for 2015 AGENCY: Drug Enforcement Administration, Department of Justice. ACTION: Notice with request for comments. SUMMARY: The Drug Enforcement Administration proposes to establish the 2015201 5 aggregate production quotas for controlled substances in schedules I and II of the Controlled Substances Act and assessment of annual needs for the list I chemicals ephedrine, pseudoephedrine, and phenylpropanolamine. DATES: Interested persons may file written comments on this notice in accordance with 21 CFR 1303.11(c)1303.1 1(c) and 1315.11(d).1315.1 1(d). Electronic comments must be submitted, and written comments must be postmarked, on or before [INSERT[INSERT 30 DAYS AFTER PUBLICATION IN THE FEDERAL REGISTER].REGISTER], Commenters should be aware that the electronic Federal Docket Management System will not accept comments after midnight Eastern Time on the last day of the comment period. ADDRESSES: To ensure proper handling of comments, please reference "Docket No. DEA-393" on all electronic and written correspondence. The DEA encourages that all comments be submitted electronically through the Federal eRulemaking Portal which provides the ability to type short comments directly into the comment field on the Web Vol. I Page 775 page or attach a file for lengthier comments. Please go to http://www.regulations.gov and follow the online instructions at that site for submitting comments. Paper comments that duplicate electronic submissions are not necessary. Should you, however, wish to submit written comments, in lieu of electronic comments, they should be sent via regular or express mail to: Drug Enforcement Administration, Attention: DEA Federal Register Representative/ODW, 8701 Morrissette Drive, Springfield, Virginia 22152. FOR FURTHER INFORMATION CONTACT: Erika Gehrmann, Office of Diversion Control, Drug Enforcement Administration, 8701 Morrissette Drive, Springfield, Virginia 22152, Telephone: (202) 598-6812. SUPPLEMENTARY INFORMATION: Posting of Public Comments Please note that all comments received in response to this docket are considered part of the public record and will be made available for public inspection online at http://www.regulations.gov. Such information includes personal identifying information (such as your name, address, etc.) voluntarily submitted by the commenter. The Freedom of Information Act (FOIA) applies to all comments received. If you want to submit personal identifying information (such as your name, address, etc.) as part of your comment, but do not want it to be made publicly available, you must include the phrase "PERSONAL IDENTIFYING INFORMATION" in the first paragraph of your comment. You must also place all the personal identifying information you do not want made publicly available in the first paragraph of your comment and identify what information you want redacted. 2 Vol. I Page 776 If you want to submit confidential business information as part of your comment, but do not want it to be made publicly available, you must include the phrase "CONFIDENTIAL BUSINESS INFORMATION" in the first paragraph of your comment. You must also prominently identify the confidential business information to be redacted within the comment. If a comment has so much confidential business information that it cannot be effectively redacted, all or part of that comment may not be made publicly available. Comments containing personal identifying information or confidential business information identified as directed above will be made publicly available in redacted form. An electronic copy of this document is available at http://www.regulations.govhttp://www.reguIations.gov for easy reference. If you wish to personally inspect the comments and materials received or the supporting documentation the DEA used in preparing the proposed action, these materials will be available for public inspection by appointment. To arrange a viewing, please see the "For Further Information Contact" paragraph above. Legal Authority Section 306 of the Controlled Substances Act (CSA), 21 U.S.C. 826, requires the Attorney General to determine the total quantity and establish aggregate production quotas for each basic class of controlled substance listed in schedules I and II and for the list I1 chemicals ephedrine, pseudoephedrine, and phenylpropanolamine. This responsibility has been delegated to the Administrator of the DEA pursuant to 28 CFR 0.100(b). The Administrator, in turn, has redelegated that authority to the Deputy Administrator, pursuant to 28 CFR pt. 0 subpt. R, App. Analysis for Proposed 2015 Aggregate Production Quotas and Assessment of 3 Vol. I Page 777 Annual Needs The proposed year 2015 aggregate production quotas and assessment of annual needs represent those quantities of schedule I and II controlled substances, and the list I chemicals ephedrine, pseudoephedrine, and phenylpropanolamine, to be manufactured in the United States in 2015 to provide for the estimated medical, scientific, research, and industrial needs of the United States, lawful export requirements, and the establishment and maintenance of reserve stocks. These quotas include imports of ephedrine, pseudoephedrine, and phenylpropanolamine but do not include imports of controlled substances necessary to provide for the medical, scientific, or other legitimate needs of the United States. In determining the proposed 2015 aggregate production quotas and assessment of annual needs, the DEA has taken into account the criteria that the DEA is required to consider in accordance with 21 U.S.C. 826(a), 21 CFR 1303.111303.1 1 (aggregate production quotas for controlled substances), and 212 1 CFR 1315.111315.11 (assessment of annual needs for ephedrine, pseudoephedrine, and phenylpropanolamine). The DEA proposes the aggregate production quotas and assessment of annual needs for 2015 by considering: (1) total net disposal of the class or chemical by all manufacturers and chemical importers during the current and two preceding years; (2) trends in the national rate of net disposal of the class or chemical; (3) total actual (or estimated) inventories of the class or chemical and of all substances manufactured from the class or chemical, and trends in inventory accumulation; (4) projected demand for such class or chemical as indicated by procurement and chemical import quotas requested in accordance with 21 CFR 1303.12,1303.12, 1315.32,1315.32, and 1315.34;1315.34; and (5) other factors affecting the medical, scientific, research, and 4 Vol. I Page 778 industrial needs in the United States, lawful export requirements, and reserve stocks, as the Deputy Administrator finds relevant. Other factors the DEA considered in calculating the aggregate production quotas, but not the assessment of annual needs, include product development requirements of both bulk and finished dosage form manufacturers, and other pertinent information. In determining the proposed 2015 assessment of annual needs, the DEA used the calculation methodology previously described in the 2010 and 2011201 1 assessment of annual needs (74 FR 60294, Nov. 20, 2009, and 75 FR 79407, Dec. 20, 2010, respectively). The DEA also specifically considered that inventory allowances granted to individual manufacturers may not always result in the availability of sufficient quantities to maintain an adequate reserve stock pursuant to 21 U.S.C. 826(a), as intended. See 21 CFR 1303.24.1303.24. This would be concerning if a natural disaster or other unforeseen event resulted in substantial disruption to the amount of controlled substances available to provide for legitimate public need. As such, the DEA proposes to include in all schedule II aggregate production quotas, and certain schedule I aggregate production quotas (gamma-hydroxybutyric acid and tetrahydrocannabinols), an additional 25% of the estimated medical, scientific, and research needs as part of the amount necessary to ensure the establishment and maintenance of reserve stocks. The resulting established aggregate production quotas will reflect these included amounts. This action will not affect the ability of manufacturers to maintain inventory allowances as specified by regulation. The DEA expects that maintaining this reserve in certain established aggregate production quotas will mitigate adverse public effects if an unforeseen event resulted in substantial disruption to the amount of controlled substances available to 5 Vol. I Page 779 provide for legitimate public need, as determined by the DEA. The DEA does not anticipate utilizing the reserve in the absence of these circumstances. The Deputy Administrator, therefore, proposes to establish the 2015 aggregate production quotas for the following schedule I and II controlled substances and assessment of annual needs for the list I chemicals ephedrine, pseudoephedrine, and phenylpropanolamine, expressed in grams of anhydrous acid or base, as follows: Proposed Established Basic Class 2015 Quotas (g) Schedule I (1-Penty1-1H-indo1-3-y1)(2,2,3,3-tetramethylcyclopropypmethanone(l-Pentyl-lH-indol-3-yl)(2,2,3,3-tetramethylcyclopropyl)methanone 1515 (UR-144) [1-(5-Fluoro-penty1)-1H-indo1-3-y1](2,2,3,3-[ 1 -(5-Fluoro-pentyl)- 1 H-indol-3-yl](2,2,3,3- 1515 tetramethylcyclopropyl)methanone (XLR(XLR1 1 11) ) 1-(1,3-Benzodioxo1-5-y1)-2-(methy1 -( 1 ,3-Benzodioxol-5-yl)-2-(methylamino)butan- lam ino)butan-1-one1 -one (butylone) 1515 1-(1,3-Benzodioxo1-5-y1)-2-(methyl-(l,3-Benzodioxo!-5-y!)-2-(methylamino)pentan-l-one lam ino)pentan-l-one (pentylone) 1515 1-(1-Phenylcyclohexyl)pyrrolidine1 -( 1 -Phenylcyclohexyl)pyrrolidine 1010 1-(5-FluoropentyI)-3-(1-naphthoyl)indole1 -(5-Fluoropentyl)-3-( 1 -naphthoyl)indole (AM2201)(AM220 1 ) 45 1-(5-FluoropentyI)-3-(2-iodobenzoyl)indole1 -(5-Fluoropentyl)-3-(2-iodobenzoyl)indole (AM694) 45 1-[1-(2-Thienyl)cyclohexyl]piperidine1 -[ 1 -(2-Thienyl)cyclohexyl]piperidine 1515 142-(4-Morpholinypethy1]-3-(1-naphthoyl)indole1 -[2-(4-Morpholinyl)ethyl]-3-( 1 -naphthoyl)indole (JWH-200)(J WH-200) 45 1-Butyl-3-(1-naphthoyl)indole1 -Butyl-3-( 1 -naphthoyl)indole (JWH-073) 45 1-Cyclohexylethy1-3-(2-methoxyphenylacetyl)indolel-Cyclohexylethyl-3-(2-methoxyphenylacetyl)indole (SR(SR-18-18 and RCS-8)RCS-8) 45 1-Hexy1-3-(1-naphthoyl)indole1 -Hexyl-3-( 1 -naphthoyl)indole (JWH-019)(J WH-0 1 9) 45 1-Methyl-4-phenyl-4-propionoxypiperidinel-Methyl-4-phenyl-4-propionoxypiperidine 2 1-Penty1-3-(1-naphthoyl)indolel-Pentyl-3-(l-naphthoyl)indole (JWH-018 and AM678) 45 1-Penty1-3-(2-chlorophenylacetyl)indolel-Pentyl-3-(2-chlorophenylacetyl)indole (JWH-203) 45 1-Penty1-3-(2-methoxyphenylacetyl)indolel-Pentyl-3-(2-methoxyphenylacetyl)indole (JWH-250) 45 1-Penty1-3-(4-chloro-l-naphthoyl)indole1 -Pentyl-3-(4-chloro- 1 -naphthoyl)indo!e (JWH-398)(J WH-398) 45 1-Penty1-3-(4-methyl-1-naphthoyl)indole1 -Pentyl-3-(4-methyl- 1 -naphthoyl)indole (JWH-122)(J WFI- 1 22) 45 1-Penty1-3-[(4-methoxy)-benzoyl]l-Pentyl-3-[(4-methoxy)-benzoyl]indole indole (SR(SR-19,-19, RCS-4)RCS-4) 45 1-Penty1-3-[1-(4-methoxynaphthoy1)]indole1 -Pentyl-3-[ 1 -(4-methoxynaphthoyl)]indole (JWH-081)(J WH-08 1 ) 45 6 Vol. I Page 780 2-(2,5-Dimethoxy-4-n-propylphenyl)ethanamine (2C(2C-P)-P) 30 2-(2,5-Dimethoxy-4-ethylphenyl)ethanamine (2C(2C-E)-E) 30 2-(2,5-Dimethoxy-4-methylphenyl)ethanamine (2C(2C-D)-D) 30 2-(2,5-Dimethoxy-4-nitro-phenyl)ethanamine (2C(2C-N)-N) 30 2-(2,5-Dimethoxyphenyl)ethanamine (2C(2C-H)-H) 30 2-(4-Bromo-2,5-dimethoxypheny1)-N-(2-methoxybenzyl)ethanamine2-(4-Bromo-2,5-dimethoxyphenyl)-N-(2-methoxybenzyl)ethanamine 15 (25B-NBOMe; 2C-B-NBOMe; 25B; Cimbi-36) 2-(4-Chloro-2,5-dimethoxyphenyl)ethanamine (2C(2C-C)-C) 30 2-(4-Chloro-2,5-dimethoxypheny1)-N-(2-methoxybenzyl)ethanam2-(4-Chloro-2,5-dimethoxyphenyl)-N-(2-methoxybenzyl)ethanamine ine 1515 (25C-NBOMe; 2C-C-NBOMe; 25C; Cimbi-82) 2-(4-Iodo-2,5-dimethoxyphenyl)ethanamine (2C(2C-I)-I) 30 2-(4-Iodo-2,5-dimethoxyphenyl)-N-(2-methoxybenzyl)ethanamine 1515 (251-NBOMe; 2C-1-NBOMe;2C-I-NBOMe; 251; Cimbi-5) 2-(Methylamino)-1-phenylpentan-l-one2-(Methy lamino)- 1 -phenylpentan- 1 -one (pentedrone) 1515 2,5-Dimethoxy-4-ethylamphetamine (DOET) 25 2,5-Dimethoxy-4-n-propylthiophenethylamine 25 2,5-Dimethoxyamphetamine 25 2[4-(Ethylthio)-2,5-dimethoxyphenydethanamine2-[4-(Ethylthio)-2,5-dimethoxyphenyl]ethanamine (2C(2C-T-2)-T-2) 30 2[4-(Isopropylthio)-2,5-dimethoxyphenyl]ethanamine2-[4-(lsopropylthio)-2,5-dimethoxyphenyl]ethanamine (2C(2C-T-4)-T-4) 30 3,4,5-Trimethoxyamphetamine3,4,5-Trimethoxyamphetamine 25 3,4-Methylenedioxyamphetamine (MDA) 55 3,4-Methylenedioxymethamphetamine (MDMA) 50 3,4-Methylenedioxy-N-ethylamphetamine (MDEA) 40 3,4-Methylenedioxy-N-methylcathinone (methylone) 50 3,4-Methylenedioxypyrovalerone (MDPV) 35 3-Fluoro-N-methylcathinone (3(3-FMC)-FMC) 1515 3-Methylfentanyl 2 3-Methylthiofentanyl 2 4-Bromo-2,5-dimethoxyamphetamine (DOB) 25 4-Bromo-2,5-dimethoxyphenethylamine (2(2-CB)-CB) 25 4-Fluoro-N-methylcathinone (4(4-FMC)-FMC) 1515 4-Methoxyamphetamine 100100 4-Methyl-2,5-dimethoxyamphetamine (DOM) 25 4-Methylaminorex 25 4-Methyl-N-ethylcathinone (4-MEC) 15 4-Methyl-N-methylcathinone (mephedrone) 45 7 Vol. I Page 781 4-Methyl-alpha-pyrrolidinopropiophenone (4-MePPP) 1515 5-(1,1-Dimethylhepty1)-2-[(1R,38)-3-hydroxycyclohexyl]-phenol5-( 1 , 1 -Dimethylheptyl)-2-[( 1 R,3S)-3-hydroxycyclohexyl]-phenol 68 5-(1,1-Dimethy5-(1,1 -Dimethyloctyl)-2-[( locty I)-2-[(1R,31 R,3S)-3-hydroxycyclohexyl]-phenol S)-3-hydroxycyclohexyI]-phenol 53 (cannabicyclohexanol or CP-47,497 C8-homolog) 5-Methoxy-3,4-methylenedioxyamphetamine 25 5-Methoxy-N,N-diisopropyltryptamine 25 5-Methoxy-N,N-dimethyltryptam5-Methoxy-N,N-d imethyltryptam ine 25 Acetyl-alpha-methylfentanyl 2 Acetyldihydrocodeine 2 Acetylmethadol 2 Allylprodine 2 Alphacetylmethadol 2 alpha-Ethyltryptamine 25 Alphameprodine 2 Alphamethadol 2 alpha-Methylfentanyl 2 alpha-Methylthiofentanyl 2 alpha-Methyltryptamine (AMT) 25 alpha-Pyrrolidinobutiophenone (a-PBP) 1515 alalpha-Pyrrolidinopentiophenone pha-Pyrrol id i nopentiophenone (a-PVP) 1515 Aminorex 25 Benzylmorphine 2 Betacetylmethadol 2 beta-Hydroxy-3-methylfentanylbeta-Hydroxy-3 -m ethy I fentany I 2 beta-Hydroxyfentanylbeta-Hydroxy fentany I 2 Betameprodine 2 Betamethadol 4 Betaprodine 2 BufotenineBufoten ine 3 CathCathinone inone 70 Codeine methylbromide 5 CodeineCodeine-N-oxide-N-oxide 200 Desomorphine 5 DiethyltryptamDiethyltryptamine ine 25 Difenoxin 50 Dihydromorphine 3,990,000 8 Vol. I Page 782 Dimethyltryptamine 35 Dipipanone 5 Fenethylline 5 gamma-Hydroxybutyric acid 70,250,000 Heroin 25 Hydromorphinol 2 Hydroxypethidine 2 Ibogaine 5 Lysergic acid diethylamide (LSD) 35 Marihuana 21,000 Mescaline 25 Methaqualone 10 Methcathinone 25 Methyldesorphine 5 Methyldihydromorphine 2 Morphine methylbromide 5 Morphine methylsulfonate 5 Morphine-N-oxideMorphine-N-oxide 350 N-(N-(1-Adamanty1)-1-penty1-1H-indazole-3-carboxamide1 -Adamanty1)- 1 -pentyl- 1 H-indazole-3-carboxamide (AKB48)(AKB48) 15 N-(1-Amino-3,3-dimethyl-l-oxobutan-2-y1)-1-pentyl-IH-indazole-3-N-( 1 -Amino-3,3-dimethyl- 1 -oxobutan-2-yl)- 1 -pentyl- 1 H-indazole-3- 1515 carboxamide (ADB-PINACA) N-(N-(1-Amino-3-methyl-l-oxobutan-2-y1)-1-(4-fluorobenzy1)-1H-indazole-1 -Amino-3-methyl- 1 -oxobutan-2-yl)- 1 -(4-fluorobenzyl)- 1 H-indazole- 1515 3-carboxamide (AB-FUBINACA) N,N-Dimethylamphetamine 25 Naphthylpyrovalerone (naphyrone) 1515 N-Benzylpiperazine 25 N-Ethyl-l-phenylcyclohexylamine 5 N-EthylamphetamN-Ethylamphetamine ine 24 N-Hydroxy-3,4-methylenedioxyamphetamineN-Hydroxy-3 ,4-methy lened ioxyamphetam ine 24 Noracymethadol 2 Norlevorphanol 52 Normethadone 2 Normorphine 18 Phenomorphan 2 PsiPsilocybin locybin 30 PsiPsilocyn locyn 30 9 Vol. I Page 783 Quinolin-8-ylQuinol in-8-y! 11-(5-fluoropenty1)-1-(5-fluoropentyl)- 1 H-indole-3-carboxylate11- indole-3-carboxylate (5-fluoro-PB-(5-fluoro-PB- 15 22;22; 5F-PB-22)5F-PB-22) Quinolin-8-ylQuin°lin-8-yl l-pentyl-lH-indole-3-carboxylatel-penty1-1H-indole-3-carboxylate (PB-22;(PB-22; QUP1C)QUPIC) 15 TTetrahydrocannabinolsetrahydrocannabinols 497,500497,500 ThiofentanylThiofentanyl 22 TilidineTilidine 10 TrimeperidineTrimeperid ine 2 Schedule IIII 1-Phenylcyclohexylam1 -Phenylcyclohexylamine ine 5 1-Piperidinocyclohexanecarbonitrile1-P iperid inocyclohexanecarbon itrile 5 4-Anilino-N-phenethyl-4-piperidine4-Anilino-N-phenethyl-4-piperidine (ANPP) 2,687,500 AlfentanilA lfentan il 17,625 Alphaprodine 3 Amobarbital 25,125 Amphetamine (for conversion) 21,875,000 Amphetamine (for sale) 37,500,000 CarfentanilCarfentan il 19 Cocaine 240,000 Codeine (for conversion) 50,000,000 Codeine (for sale) 46,125,000 Dextropropoxyphene 19 Dihydrocodeine 101,375 Diphenoxylate 1,337,500 Ecgonine 174,375 Ethylmorphine 3 Fentanyl 2,108,750 Glutethimide 3 Hydrocodone (for conversion) 137,500 Hydrocodone (for sale) 99,625,000 Hydromorphone 6,250,000 Isomethadone 5 levo-Alphacetylmethadol (LAAM)(LAAM) 4 Levomethorphan 5 Levorphanol 3,375 LisdexamfetamLisdexamfetamine ine 29,750,000 Meperidine 6,250,000 Meperidine IntermediateIntermediate-A-A 6 Meperidine IntermediateIntermediate-B-B 1111 Meperidine IntermediateIntermediate-C-C 6 Metazocine 1919 1010 Vol. I Page 784784 MethadoneMethadone(for (for sale)sale) 31,875,00031,875,000 MethadoneMethadone IntermediateIntermediate 34,375,00034,375,000 MethamphetamineMethamphetamine 2,061,3752,061,375 [1,250,000[1,250,000 gramsgramsof oflevo-desoxyephedrine levo-desoxyephedrine forfor useuse inin aa non-controlled,non-controlled, non-prescriptionnon-prescription product;product; 750,000750,000 gramsgrams forfor methamphetaminemethamphetamine mostlymostly forfor conversionconversion toto aa scheduleschedule IIIIII product;product; andand 61,37561,375 gramsgrams forfor methamphetaminemethamphetamine (for(for sale)]sale)] MethylphenidateMethylphenidate 83,750,00083,750,000 MorphineMorphine (for(for conversion)conversion) 91,250,00091,250,000 MorphineMorphine (for(for sale)sale) 62,500,00062,500,000 NabiloneNabilone 18,75018,750 NoroxymorphoneNoroxymorphone (for(for conversion)conversion) 17,500,000 NoroxymorphoneNoroxymorphone (for(for sale)sale) 1,475,000 OpiumOpium (powder)(powder) 112,500 OpiumOpium (tincture)(tincture) 687,500687,500 OripavineOripavine 22,750,00022,750,000 OxycodoneOxycodone (for(for conversion)conversion) 8,350,0008,350,000 OxycodoneOxycodone (for sale)sale) 137,500,000 OxymorphoneOxymorphone (for conversion)conversion) 21,875,00021,875,000 OxymorphoneOxymorphone (for sale)sale) 7,750,000 Pentobarbital 35,000,00035,000,000 Phenazocine 6 Phencyclidine 19 Phenmetrazine 3 Phenylacetone 9,375,000 Racemethorphan 3 Remifentanil 3,750 Secobarbital 215,003 Sufentanil 6,255 Tapentadol 12,500,000 Thebaine 125,000,000 List II Chemicals Ephedrine (for conversion) 1,000,000 Ephedrine (for sale) 3,000,000 Phenylpropanolamine (for conversion) 44,800,000 Phenylpropanolamine (for sale) 8,500,000 Pseudoephedrine (for conversion) 7,000 Pseudoephedrine (for sale) 224,500,000 1111 Vol. I PagePage 785785 The Deputy Administrator further proposes that aggregate production quotas for all other schedule I and II controlled substances included in 21 CFR 1308.111308.1 1 and 1308.121308.12 remain at zero. Pursuant to 21 CFR 1303.131303.13 and 21 CFR 1315.13,1315.13, upon consideration of the relevant factors, the Deputy Administrator may adjust the 2015 aggregate production quotas and assessment of annual needs as necessary. Comments In accordance with 21 CFR 1303.11(c)1303.1 1(c) and 1315.11(d),1315.1 1(d), any interested person may submit written comments on or objections to these proposed determinations. Based on comments received in response to this notice, the Deputy Administrator may hold a public hearing on one or more issues raised. 21 CFR 1303.11(c)1303.1 1(c) and 1515.11(e).1515.1 1(e). In the event the Deputy Administrator decides to hold such a hearing, the Deputy Administrator will publish a notice of the hearing in the Federal Register. After consideration of any comments or objections, or after a hearing, if one is held, the Deputy Administrator will issue and publish in the Federal Register a final order establishing the 2015 aggregate production quota for each basic class of controlled substance and establishing the assessment of annual needs for the list I chemicals ephedrine, pseudoephedrine, and phenylpropanolamine. 21 CFR 1303.11(c)1303.1 1(c) and 1315.11(f).1315.11(f). Dated: Thomas M. Harrigan, Deputy Administrator. 1212 Vol. I Page 786 37772 Federal Register/ Vol. 79, No. 127/127 /Wednesday, Wednesday, July 2, 29142014/Notices / Notices INTERNATIONAL TRADE DATES: Interested persons may fifilele comment and identify what information COMMISSION written comments on this notice in you want redacted. L accordance with 21 CFR 1303.11(c)1303.11(c) and IfIf you want to submit confidential fi[USITClSITC SESE-14-0231-14-0231 1315.11(d).1315.11(d). Electronic comments must business information as part of your be submitted, and written comments comment, but do not want it to barnaclebe made Sunshine Act Meetings must be postmarked, on or before publicly available, you must include the phrase "CONFIDENTIAL BUSINESS AGENCY HOLDING THE MEETING: United August 1,1. 2014. Commenters should be INFORMATIONINFORMATION",' in the first paragraph States International Trade Commission. aware that the electronic Federal Docket of your comment. You must also TIMEtime ANDand DATE:date: July 11,11, 2014 atet 11u a.m. Management System will not accept comments after midnight Eastern Time prominently identify the confidential PLACE: Room 101.101. 500 E Street SW., on the last day of the comment period. business information to be redacted Washington, DC 20438.20436, Telephone: within the comment. If ua comment has ADDRESSES:addresses: To ensure proper handling (202) 205-2000. so much confidential business comments, please reference "Docket STATUS:status: Open to the public. of comments, please reference "Docket information that it cannot be effectively No. ➢EADEA-393"-393" on all electronic and MATTERS TO BE CONSIDERED: redacted.redacted, all or part of that comment written correspondence. The DEA 1.1. Agendas for future meetings: None. may not be made publicly available. encourages that all comments be 2. Minutes. Comments containing personal submitted electronically through the 3. Ratification List. identifying information or confidential 70a—TA-515-521 Federal eRulemaking Portal which 4. Vote in Inv. Nos. 701-TA-515-S21 Federal eRulemaking Portal which business information identified as provides the ability to type short and 73173 l-TA-125—TA-125I-12571-1257 provides the ability to directed above will be made publicly comments directly into the comment (PreljninarYKertain(PreliminaryKCertain Steel Nails from comments directly into available in redacted form. India, Korea.Korea, Malaysia, Oman, Taiwan, field on the Web page or attach a file for An electronic copy of this document Turkey, and Vietnam). The Commission lengthier comments. Please go to hap:/i«p; is available at http:// is currently scheduled to complete endand //www.regulations.gov//www.reguiations.gov and followfoliow the www.regulations.gov for oasyeasy reference. file its determinations on July 14,14, 2014; online instructions at that site for If you wish to personally inspect the views of the Commission are currently submitting comments. Paper comments comments and materials received or the scheduled to he completed and filed on that duplicate electronic submissions supporting documentation the DEA July 21.21, 2014. are notnol necessary. Should you, however, used in preparing the proposed action, 5. Outstanding action jackets: None. wish to submit written comments, in . these materials will be available for In accordance with Commission '• In accordance lieu of electronic comments.comments, they public inspection by appointment. To above, not policy, subject mattermattor listed above, not should be sent via regular or express arrange a viewing, please see the FOR disposed of at the scheduled meeting.meeting, mail to: Drug Enforcement FURTHER INFORMATICSINFORMATION CONTACT agenda of the may be carried over to the agenda of the Administration.Administration, Attention: DEA Federal paragraph above,above. following meeting. Register Representative/ODW, 8701 Legal Authority ➢yBy order of the Commission: Morrissettc Drive, Springfield, Virginia L 22152. Issued: June 30.2014.30. 2014. 22152. Section 306 of the Controlled Substances Act (CSA). 21 U.S.C. 826, William R. Bishop, FOR FURTHER INFORMATIONINFORMATION CONTACT: Act 826, requires the Attorney General to SupervisoryHearingsSupervisory Hearings and informationInformation Erika Gehrmann.Gehrmann, Office of Diversion determine the total quantity and Officer. Control, Drug Enforcement establish aggregate production quotas :FR[FR DOC.Doc. 1014-136792014-1S679 Filed 6-30-14:6-30-14; 4:15 pm] Administration, 8701 MorrissetteMorrlssette Drive, for each basic class of controlled BiLLINO8ILUN0 CODE 702D-02-9702D-02-P Springfield, Virginia 22152, Telephone: substance listed in schedules I and II (202) 598-6812. substance and for the list I chemicals ephedrine, SUPPLEMENTARY INFORMATION:INFORMATION: pseudnephedrine,pseudoephedrine, and DEPARTMENT OFOP JUSTICE phenylpropanolamine. This Posting of Public Comments responsibility has been delegated to the Drug Enforcement Administration Please note that all comments Administrator of the DEA pursuant to [Docket[Docket No. DEA-393] received in response to this docket are 28 CFR 0.100(b),0.100(b). The Administrator, in considered part of the public record and turn, has redelegatedrcdelegatcd that authority to Proposed Aggregate Production will be made available forfar public the Deputy Administrator, pursuant to Quotas for Schedule II and IIII Controlled inspection online at http://http:/) 28 CFR part 0 subpart R, App. Substances and Assessment of www.regulations.gov.www.reguiations.gov. Such information Analysis for Proposed 2015 Aggregate Annual Needs for the List II Chemicals includes personal identifying.identifying . Analysis for Proposed 2015 Production Quotas, and Assessment of Ephedrine, Pseudoephedrine, and information (such as your name, Production Quotas and Assessment of PtienylpropanGlamlnePhenylpropanolamine for 2015 address.address, etc.) voluntarily submitted by Annual Needs the commenter. The proposed year 2015 aggregate AGENCY:agency: Drug Enforcement the commenter. The proposed production quotas and assessment of Administration. Department of Justice. The Freedom of Information Act production quotas and assessment of (FOIA) applies to all comments annual needs represent those quantities ACTION: Notice with request for (FOIA) received. If you want to submit personal of schedule I and II controlled comments. identifying information (such as your substances, and the list I chemicals SUMMARY:summary: The Drug Enforcement name, address, etc.)otc.Jas as part. of your ephedrine, psoudoophedrine,psoudoophedrine. and Administration proposes to establish the comment, but do not want it totn be made phenylpropanolaminu.phenylpropanolamine, to be 2015 aggregate production quotas for publicly available, you must include the manufactured in the United Stales in controlled substances in schedules 1I and phrase "PERSONAL IDENTIFYING 2015 to provide for the estimated II of the Controlled Substances Act and INFORMATION" in the firstfust paragraph medical, scientific, research, and assessment of annual needs for the list of your comment. You must also place industrial needs of the United States, I chemicals ephedrine, all the personal identifying information lawful export requirements, and the L ppseudoephedrine. d ph d 'n andnd you do not want made publicly establishment and maintenance of phenylpropanolamine. available Inin the first paragraph of your reserve stocks. These quotas include Vol. I Page 787 Federal Register/ Vol. 79, No. 127/Wednesday,127/Wednesday. July 2, 20142014/Notices /Notices 37773 importsimports of ephedrine.ephedrine, pseudoephedrine, (5)(5) other factors affecting the medical, II aggregate production quotas (gamma-(gamma- and phenylpropanolamine hut do not scientific, research,research, and industrialindustrial needs hydroxybutyrichydroxybulyric acid and c tetrahydrocannabinols), an additional includeinclude importsimports of controlled inin the United States, lawfullawful export substancessuhslances necessary to provide for the requirements,requirements, and reservereserve stocks, as the 25% of the estimated medical, medical, scientific, or other legitimatelegitimate Deputy Administrator fifindsnds relevant.relevant. scientific, and researchresearch needs as part of needs of the United States. Other factors the DEA considered inin the amount necessary to ensure the InIn determining the proposed 2015 calculating the aggregate production establishment and maintenance of aggregate production quotas and quotas, but not the assessment of annual reservereserve stocks. The resultingresulting established assessment of annual needs, the DEA needs, includeinclude product development aggregate production quotas will reflectreflect has taken intointo account the criteria that requirementsrequirements of both hulkbulk and finished these includedincluded amounts. This action the DEA isis requiredrequired to consider inin dosage form manufacturers, and other will not affect the ability of accordance with 21 U.S.C. 826(a), 21 pertinent information.information. InIn determining manufacturers to maintain inventoryinventory CFR 1303.11 (aggregate(aggregate production the Proposedproposed 2015 assessment of annual allowances as specified by regulation.regulation, quotas for controlled substances), and needsneeds, the DEA used the calculation The DEA expects that maintaining this 21 CFR 1315.11 (assessment(assessment of annual methodology previously described inin reservereserve inin certain established aggregate needs for ephedrine, pseudoephedrine, the 2010 and 2011 assessment of annual production quotas will mitigate adverse and phenylpropanolamine). The DEA needs (74(74 FR 60294.60294, Nov. 20,20. 2009, and public.public effects ifif an unforeseen event proposes the aggregate production 75 FR 79407, Dec. 20. 2010, resultedresulted inin sblistanlialsubstantial disruption to the quotas and assessment of annual needs respectively).respectively). amount of controlled substances for 2015 by considering: (1)(1) Total net The DEA also specifically considered available to provide for legitimatelegitimate disposal of the class or chemical by all that inventoryinventory allowances granted to public need, as determined by the DEA. manufacturers and chemical importersimporters individualindividual manufacturers may not The DEA does not anticipate utilizing during the current and two preceding always resultresult inin the availability of the reservereserve inin the absence of these years: (2)(2) trends inin the national raterate of sufficient quantities to maintain an circumstances. net disposal of the class or chemical;chemical: (3)(3) adequate reservereserve stock pursuant to 21 The ➢eputyDeputy Administrator.Administrator, therefore, total actual (or(or estimated) inventoriesinventories of U.S.C. 826(e),026(a), as intended.intended. See 21 CFR proposes to establish the 2015 aggregate the class or chemical and of all 1303.24. This would be concerning_ ifif a production quotas for the following substances manufactureckfrommanufaclured from the class natural disaster or other unforeseen - schedule-II and IIII controlled substances or chemical.chemical, and trends inin inventoryinventory - event resultedresulted inin substantial disruption and assessment of annualneedsannual" needs for the accumulation; (4)(4) projected demand for to the amount of controlled substances listlist II chemicals,chemicals ephedrine, such class or chemical asas. indicatedindicated by available to provide for legitimatelegitimate pseudoephedrine, and procurement and chemical importimport public need. As such, the DEA proposes phenylpropanolamine, expressed inin quotas requestedrequested inin accordance with 21 to Includeinclude inin all schedule IIII aggregate grams of anhydrous acid or base, as CPRCFR 1303.12, 1315.32.1315.32, and 1315.34; and production quotas, and certain schedule follows: Proposed es-es Basic class tablished 2015 quotas (g)(g) Schedule II (1(1-Peptyl-1H-indol-3-yl)(2,2.3,3-letramethytcyctopropyl)me1hanone -Penty1-1H-indo1-3-0(2.2.3,3-tetramethyloyclopropyl)melhanone (UR-144)(UR-144) 15 [1.(5.Fluoresenty0-1H-indc1-3111(2,2.3,3-letramethyleyclopropyl)methanone[1-(5-Huoro-pentyl)-1H-iodol-3-yl|(2,2.3,3-letramethylcyclppropyl)methanone (XLR11)(XLR1 1) 15 1-(1.3-Benzodiovul-5-y1)-2-(methylamlno)bulan-11-(1,3-Berizodioxol-S-yl)-2-(melhyiarrilno)bulan-1-on8-ena (butylone)(butylone) 15 1-(1.3-Benzodio9M-5.y1)-21-(1,3-Benzodioxol-5-yl)-2L(meihylamino)pentan-l-one,(meihylamlno)Pentan-1-one (pentylone)(pentylone) ; 15 1-(1-Phenylcycloheryl)pyrrondine1-<1-Phenylcyclohexyl)pyrrolidirie - 10 1-(5-Fluoropenty9-3.(1-naphlhoylinclole1-(5-Fluoropertyl)-3-(1-naphthoyl)indole (AM2201)(AM2201) 45 1-(5-Fluoropenly9-3.(2-iodobenzoyOindolel-(S-Fluoroperityl)-3-(2-iodobenzoyi)indole (AM694)(AM694) 45 111-(2-Thienyl)eyclohocApiperidine1-[1-(2-Thionyl)cycloheicyl|piperidine 15 112-(4-Morpholinyl)elhy11-3-(1.naphlhoHindole1-(2-(4-Morpbolinyl)eihyl|-3-(l-naphthoyl)indole (JWH-200)(JWH-200) 45 1-Buly1.3.(1-naphthoyl)Indolel-Gulyl-3-(1-naphthoyl)lndol0 (JWH-073)(JWH-073) 45 1-Cyclohexylelhyl-342-melhoxyphenylacetypindola1-Cyclohexylelhyl-3-(2-melhoxyphenylaeetyl)ifidole (SR(SR-18-18 andarid RCSRCS-8)-8) 45 1-Hexy1-3-(1-naphtheyl)indOle1-Haxyl-3-(l-naphlhoyl)indole (JWH-019)(JWH-019) 45 1-Methyl-4-phenyl-4-propOnoxypiper;thie1-Methyl-4-phenyl-4-propionoxypiperid:rie .. 2 1-Pent91-3-(1-naphlhoyl)indole.(JWH-018VPentyl-3-(1-naphthoyl)indolB.(JWH-Oia'and'AM678)" and WM678). '; 45 1-PenN1.3.(2.chlorophenylacetylkodole1-Pentyl-3-(2-chlorophenylaeetyl)indole (JW1-1-203)(JWH-203) 45 I.Penty1-3.(2-reethonchenyfacetvl)indole1-Pentyl-3-(2-me(hoxyplieny (acetyl) indole (JWH-250)(JVVH-250) I :... 45 1-Penty1-3-(4-chloro-1-naphihoyl)indole1-Pentyl-3-(4-chioro-l-naphlhoyl)indole (JWH-398)(JWH-390) 45 1-Penty1.3-(4-methyl-1-napnthoyl)indole1-Pentyl-3-(4-melhyl-1.naphthoyl)indole (JWH-122)(JWH-122) 45 1-Penty1-31(4.methory)-benzcy9indola1-Pentyl-3-((4-methoxy)-benzoyl]indole (SR(SR-19.-19, RCSRCS-4)-4) 45 1-Pentyl.3.11-(4-methoxynaphthoylflindole1-Pertyl-3-[1-(4-methoxynaphUioyl)lindole (JWF1-081)(JWH-081) : 45 2-(2,5-Cirnethoxy-4.n.pronylpbeny0stanamine2-{215-Oimelhoxy-4-n-pi'opylpheriyl)etliariamine (20-P)(2C-P) . 30 2-(2,5-Dimeihoxy.4-elhylphenyl)elhanamine2-(2,5-Dimethoxy-4-ethylpheriyl)elhanamine (2C(2C-E)-E) 30 2-(2,5-Dimethoxy-4-melhyphenyl)mhanamins2-<2,S-Oimethoxy-4-melMrylphenyl)eihanamine (2C-0)(2C-D) : 30 2-(2,5-Dimelhoxy-4-nilro-phenyl)ethanamine2-(2.S-Dimelhoxy-4-nilro-phenyl)ethanamine (2C(2C-N)-N) : 30 2-(2,5.Dimathoxyphenyl)ethanamine2-(2,5-Dimelhoxyphenyl)ethanamine (2C(2C-H)-H) 30 2-(4-13mmo-2.5-dirnelhoxypheny1)-N-(29methoxybenzyl)elhar2-(4-Bromo-2,5-dimeihoxyphenyl)-N-(2-methoxybenzyl)elharamlne mine (2513.NBOMe;(25B-NBOMe; 2C-B-11130Me;2C-B-MBOM6; 258;25B: CidCimbi-36)-11)1-36) 15 2.(4-Chlom-2,5-dimethexyphenyllelhanamlne2-(4-Chloro-2,S-dimeiho*yphenyljsihanamlne (2c(2C-C)-c) 30 2-(4.Chlore-2,5.dimethoxypheny1)-N-(2-melhoxybenzyl)ethanamlne2-(4-Chloro-2,5-dimelhoxyphenyl)-N-(2-me1hoxybenzyl)ethanamlne (25C-NROMe:(25C-NBOMe; 2C-C-NBOMe; 25C; Cimbi-82) 15 2-(4-lodo-2.5-dirnethoxyphenyl)elbanamine2-{4-lodo-2,5-dimeihoxyphenyl)ethanamine (261)(2C-I) 30 2-(4-ludo-2.5-dimathoxyPtuany1)-N-(2-melhonytenzyl)ethenemine2-(4-lndo-2,S-dimathoxyphenyl)-N-(2-methoxybenzyl)elhafiamine (251-NBOMo;(251-NBOMo; 2C-l-NBOMe; 251;251: Cimbi-5) 15 2.(Methylamino)-1-pnenylpentand2-{Methylamiho)-1-phenylpentan-1-one one (oentedrone)(pentodrono) ... 15 Vol. I PagePage 788 > A -• o to IA s o z w -j N9 & V> A g" ft Ss P Z o_ < n r? PS £- 3 Q. CD •n M It 2014 / NotiCeS Wednesday,•< (Lily 2, vj CO No. 127/ sj Federal Register / V01. 79, 37774 OQ • © ts> Proposed15 es- in & o> S> IA w CD A CO Basice class tablished 2015 r w D) quotas111 (g) 2.5.Dimelhoxy-4-elhylamphelamine3 (DOET) 25 25 i» 2,5-Dimelhost4-n-propylirdophenothylamino s" 2,5-Dirnethogyamphelamine 25 2.[4.(Ethylthio)-2.5.dimethcxyphanyllethanamine (2Co -T-2) 30 ® Ofi Hi 30 2-(4-(IscpropAinio).2,5-dimelhosyphenyllethanamine (2C-T-4)& 3,4.5-Trimelhoxyamptelamine 1111 25 3,4-Mathylenedioxyamphetamtne (MDA) 55 3,4-Methylenedioxymethamphelamine (MDMA) 50 40 3,4-Methylenedioxy-N-othylamptielamins (MDEA) s i I I ! ; I 3,4-Methylenedloxy.N.methylcathInone (mothylono) 5 50. 3.4.Methylenedoxypyrovalerone (MDPV) 35 3-Fluoro-N-mothyloathinone (3-RAC) 15 3.Methyllentanyl 2 I j I 3-Methyllhiolentanyl ! 2 4-Bromo-2,5-dimethoxyamphelamine (DOB) 25 4-51mmo-2,5.dimethoxyphenethylamine(2cs) i 25 4.Fluoro.N.methy1cathinone (4-FMC) : 15 : 111 : ! I 4-Mathoxyamphelamine it! 100 4-Methyl-2,5-dirnethosyamphetamine (DOM) ' 1 25 i : ; i I I 4.Methylaminorex 1 25 4-Methyl-N-eihylcallenono (4-MEC) 1 15 i I I I I I 1 4-Methyl.N.methylcathinone (meptedrone) i 45 4-Methyldilpha-pynolidinopioPioPhonono (4.AlePPP) ! 15 6.(1,1.0imelhylhepty1)-2.1(11,1,3S)-3-hydroxycyclehexyll-phenol r 68 ! 2. i o k : I s e. i S 53 5.(1,1.0imethyloctY0-2-((111.35)-3.hydroxycydoheryllahenolf!l (cannabicyclohexanol or CP-47,497 C8-bornolog) ; II I I II II ! 2 5-Mathoxy-3.4-methylenedioxyamphetamine I! 5-Methoxy-N.N-cliisopropyluyplamine 2 I : 5.1vIethoxy-N.N-dirnelhyltryplamine I 2 Acetyl-alpha-mathyllentanyl : Acetyldhydrocodeine Acetylmethadol Allylprodino I I i 1 I I i j Alphacetylmathadol i!lllI,i!!!lirMSf":|!*lIi S«coMM«KKK2S35saSS58!SMro5asSSSS!S8SB88 alpha.Ethyleyptamine i 2 M r i I 1 Alphamoprodine i w ill! if ill! • I II II 1 ] Alphamethadd i ro : III alpha-Methyllentanyl III alpha-Methylihiofentanyl ro alpha.Methyltniptamine (AMT) 2 cn m i 1 alpha.Pyreoldinobutiophenone (a-PBP) I vi § 1 alpha-Pyrrolidinopentiophenone (a-PVP)II! 3 AminoreS 2 Dilenorin 50 ID id P i P 1 j ! 3.990,000 Dihydromorphine i UOOVVI801S 1 M | M 35 i Dimethyltryplamine ! in ! ; Mclean!, ! 5 in nil i!!! I I M : ! ! i Fenelhylline : o o o g g "ro ! I i 70,250,000 • gamma-Elydroxybuiyric acid : in 10 : i i j M M ; ! * : Heroin Jm: 25 10 : 1 Nil |m 2 ill! i : l!i! IN! "II Hydromorphinol III! Hydroxypethidne 2to Ibogaine 5in u O 35 Lysergic acid diethylamide (LSO) ; o © M ; \ ! i : \ I i I I 21,000 I I Marihuana II Mescaline 25to 10-> Melharlealene ro Mellicathinone 25tfiOyioci 5in Methyldescrphine r 2to I Methyldihydromorphino wmi— CD 0) "0 CD co -J Vol. I PageCO 789 Federal RegisterRegister/ / VOl.Vol. 79, NO,No. 127127/ / WedneSday.Wednesday. Julyly 2,2. 2014/Notices 37775 Proposed es-es • Basic class tablished 2015 L, °LOOMSquotas (g)(g) Morphine methylbromide 5 Morphine Mettylsulfonatemethylsulfonate 5 MorphineMorphine-N-oxide-N-oxide 350 N-(1-Adamentyl)-1-pentyl-1H-Indazole-3-carboxamdeN-(1-Adamantyl)-1-pentyl-1H-indazole-3-carboxamide (AKB48)(AKB48) 15 N-(1-Aminc-3,3-climethy1-1-exobutan-2-y1)-1-penly1-1H-Indazola-3-earboxamideN-(1-Amino-3,3-dimelhyM-oxobutan-2-yl)-1-penlyl-1H-indazole-3-carbOxannid9 (A0B-PINACA)(ADB-PINACA) 15 N.(1amino-3-methyl-l-ozobutan-2-y11-1-(4-fluorobenz)N-(1-Amino-3-methyM-oxobutan-2-yl>-1-(4-fluorobenzylMH-indazole-3-carboxamide,11-1H-indazole-3-cartexamide (M3-FUBINACA)(AB-FUBINACA) 15 N.N-N.N-DimelhylamphetamineDimelhylamphetamine 25 NapMhylpyrovaleroneNaphlhylpyrovalerono (naphyrone)(naphyrone) 15 25 N-BenzylpiperazineN-Benzy1pipera2ine - : N-Elhyl-l-phenylcyclohexylamineN-Elhyl-1 -phenylcydohexylamina 5 N-ElhylemphalamineN-Elhylamphelamine 24 N-Hydroxi-3,4-methylenedioxyamphatamineN-Hydroxy-3,4-methy!enedioxyamphatamine • 24 NoracyrnelhadolNoracymelhadcl ••• 2 NorlevorphandNorlcvorphanol .' 52 NOMIethadoneNormethadone 2 Normorphine 18 Phenomorphan 2 Pallocybin 30 Psilocyn 30 Quinclin-811QuinoHn-8-yl 1l-(S-fluoropentyl)-1H-indCle-3-carboxylato-(5-flucropentyI)-1H-indole-3-carboxylato (5-fluoro.PB-22;(S-fluoro-PB-22; 5F-PB-22)SF-PB-22) 15 Quinolin-8-y1Quinolin-8-yl 1-penty1-1N-indole-3-carbaxylate1-pentyMH-indole-3-carboxylate (PB-22:(PB-22: OUPIC)QUPIC) 15IS TotrahydrocannabinolsTetrahydrocannabinols 497.500 Thiofenlanyl 2 Tilidine 10 Trimeperidine 2 Schedule IIII 1-Phenylcyclohexylamine 5 1-Piperidinecyclohexanecarbonitdle1-Plperidinocyclohexanecarbonitrile 5 4-Anilino-N-phenethy1-4-piperidine4-Anilino-N-phenethyl-4-piperidine (ANPP)(ANPP) ... 2,587,500 Allentanil 17.625 Alphaprodine 3 AmobarbitakAmobarbitat 25,125 Amphetamine (for(for conversion) 21,675,00021,875,000 'Amphetamine'Amphetamine (for(for sale) 37.500.00037,500.000 CarfentanilCarfenianil ; 19 Cocaine 240,000 CodeineCodoinc (for(for conversion) 50,000,000 Codeine (for(for sale) 48,125.00046.125,000 DextropropexypheneDextropropoxyphene 19 Dihydr000deineDihydrocodeine 101,375 Diphenoxylate .:' 1,337,500 EcgonineEegonine 174,375 EthylrnorphineEihylmorphine 3 Fenlanyl 2,108.750 GlutethimidaGlutethimide 3 HydrocodoneHydrooodono (for(for conversion) 137,500 Hydrocodone (for(for sale) 99,625,00099.625,000 Hydromorphone 6.250.0006,250.000 IsornethedoneIsomelhedone 5 revaalphacetylmethadollevo-Alphacetylmethadol (LAAM)(LAAM) 4 Levomethorphan 5 'LevarphanolLevorphanol 3,375 ❑sdexamfetamineLisdexamfetamine 29,750,000 MoperidlneMeperidine 6,250,0006,250.000 Meperidine IntermediateInfermediate-A-A a. 6 Meperidine IntermediateInlermediate-B-13 II11 Meperidine Intermediatelniermediate-C-C : 6 Metazocine 19 Methadone (Mr(for sale) 31,675,00031,875,000 Methadone IntermediateIntermediate 34,375,000 metamphelamineMelhamphotamine 2,061.3752,061,375 [1(1 ,25%000 ,260,000 grams of lavoelesozyciphethinelevo-desoxyephedrine for use Inin a nonnon-controlled,-controlled, non-prescription product; 750.000750,000 grams for methamphetmethamphetamlne mine mostly forlor conversion to a schedule IllIII product; and 61,37561 ,375 grams forlor rnethamphetaminemethamphetamine (tor(for sale)]. 83,750,000 Methylphenidale ...: 83,750,000 91,250,000 Morphine (for(for conversion) 62,500.000 Morphine (for(for sale) 62,50%000 18,750 Nabilone 17500,00017.500,000 NOrOxyrnorphOneNoroxymorphone (far(for conversion) Vol. I PagePage 790 f 37776 Federal Register/Vol. 79, No. 127/Wednesday,127/Wednesday, July 2, 2014 /Notices Proposed es-es Basic classdass tablished 2015 c.,c quotas(9)quotas(g) NoroxymorphoneNoroxymorprtone (for(for sale) 1.475,000 Opium (powder)(powder) 112,500 Opium (tincture)(tincture) 667,500587,500 OtipavineOripavine 22,750,00022.750,000 Oxycodone (tor(for- conversion) .... 8.350,000 OxycedeneOxycodone (for(for sale) 137.500,000 Oxymorphone(forOxymorphone (for conversion) 21.875,000 Oxymorphone (for(for sale) . 7.750,0007.760,000 Pentobarbital 35,000,000 PhenazocinePhenazoeine 6 Phencyclidine 19 PhenmatrazinePhenmetrazine 3 PhenylacetonePrienylacotone 9,375,0009,375.000 PacemethorphanRacemethorphan 3 Remllentanll 3,750 Secobarbital 215,003 SufantanilSufentanil 6,2555.255 TapentadolTapemadd 12.50012.500,000 000 Thebaine 125,000,000126.000, COO List II Chemicals EphedrineEpbedrine (for(for conversion) 1,000,0001,000.000 EphedrineEphedrino (for(far sale) 3,000,0003.QOO.OOO PhonylpropanolaminePhenylpropanolamine (for(lor conversion) 44.800.00044,000.000 Phenylpropanolamine (for(for sale) 8,500.0000,500.000 EseucloophddrinePscudoephedrine (tar(for conversion) .• 7,0007.000 PseudoephedrinePseudoeph edrine (ler(for sale) 224.500.00022d.SOO.OQO The Deputy Administrator further pseudoephedrine.pseudoephedrine, and between October 2003 and September proposes thatthai aggregate production phenylpropanolamine. 21 CFR 2013. It also discusses regulatory quotas forfar all other schedule I and II 1303.11(c)1303. life] and 1315.11().1315.11(1]. impacts on State, local, and tribal c controlled substances included inin 21 governments, small business, wages.wages, L Dated: JuneJuno 26, 2014. and economic growth. Chapter IIH offers CFR 1308.111308.11 and 1308.121308.12 remain at Thomas M. Harrigan, zero. Pursuant tolo 21 CFR 1303.13 and 21 recommendations for regulatory reform. Deputy Administrator. CFR 1315.13,1315.13, upon consideration of the Part II summarizes agency compliance (FR[FR Doc. 2014-155492014-15C49 Filedfiled 7-1-14: 8:438;4S ailam) relevant factors, the Deputy with the Unfunded Mandates Reform Administrator may adjust the 2015 BILLINGBILLINQ COVECOCO 4410-09-P Act.Act aggregateaggrogate production quotas and OMBMB requests that comments be assessment of annual needs as submitted electronically to OMB by necessary. ' OFFICE OF MANAGEMENT AND September 2.2, 2014 through BUDGET www.regulations.gay.www.reguhtion3.gov. Comments DATES: To ensure consideration of Draft 2014 Report to Congress on the In accordance with 21 CFR 1303.11(c)1303.11(c) comments as OMB prepares this Draft Benefits and CastsCosts of Federal person Report for submission to Congress, and 1315.11(d).1315.11(d), any interested person Regulations and Unfunded Mandates may submit written comments on or.or . comments must be in writing and on State, Local, and Tribal EntitiesEntitles objections to these proposed received by September 2, 2014. determinations. Based anon comments.comments . AGENCY:agency: Executive Office of the ADDRESSES: Submit comments byby one of received in response to this notice, the President, Office of Management and the following methorlsmethods: Deputy Administrator may hold aa. Budget. , • www.regulations.gov: Direct public hearing on one or more issues AG110N:ACTION: Notice of availability and comments to Docket ID OMBOMB-2014--2014- raised. 21 CFR 1203.11(c)i303.11(c) and request for comments. 0002 " 1515.11(e).1515.11(e). In the event the Deputy • Fax.Fax: (202) 395-72E5395-7285 • Administrator decides to hold such a SUMMARY:summary: The Office of Management • Mail: Office of Information and hearing, the Deputy Administrator will and ➢udgetBudget (OMB) requests comments Regulatory Affairs. Office of publish a notice of the hearing in the on its Draft 2014 Report to Congress onan Management and Budget, Attn: Mabel Federal Register. After consideration of the Benefits and Costs of Federal EcholsEchols, NEOBNEOB, Room -1020210202, 725 17th17th any comments or objections, or after a Regulations, available at: Mtp://http:// Street NW..NW., Washington, DC 20503. To hearing, if one is held, the Deputy, www.whitehouse.goviamblinlaregwww.whiiehouse.gov/ontb/inforeg_ ensure that your comments are received,received. Administrator will issue and publish in regpoLrepons_congress/.regpol_reports congress/. The Draft we recommend that comments on this the Federal Register a final order Report is divided into two pans.parts. Part I draft repealreport be electronically submitted.submitted, establishing the 2015 aggregate contains two chapters. Chapter I All comments and recommendations production quota for each basic class of examines the benefits and costs of major submitted in response to this notice will controlled substance and establishing Federal regulations issued in fiscal year be made available to the public,public. the assessment of annual needs for the 2013 and summarizes the benefits and including by posting them on OMB's Lc list I chemicals ephedrine, costs of major regulationsregulations issuedissued Web site. For this reason, please do not Vol. I Page 791 ftespcmc DdjeBru P CnmaanvLCnranfinv 1—CommentCerement— AmrmntAmount Response Pnm^.icd-AFQ.Prnpotrd APO EaiaMidudPdatifishrt1APQ APO ' Change «B*NBOMe2WNBOMe " ineremg AP(1 ^PQ sufficient 151.5 1515. (b)(4)(b)(4) increase APO _5 4r0 suniciene - 25C-11•1130kle • irilnaM&EQ-i bilt1 ,... iS _APOAPQ_sufficient sufficient li15 1515 • 2SI-NBQMe2SI-1•030Mc inctcaicinrrease APQAPO iS A£0APO SHlItfiMsueient IS15 J515 1£M£1•FMC jr^rp-a^*increase ftPOAPO i5 • APQAPO wjQcientsufficient 1515 II15 - 1-fMC4-FMC • jmiratcilgorase APQ.6PC) X5 APQ^ufTirignlAPO sufficient li15 1515 - 5 APQ sufTtcienl 15 .15 - 4-MEC4-MEC infTMSCincrease APQAPO 5 APO sufficient IS .I5 - UMcPPP4./..1ePPP jnrrmicincrease APO AS AMApO '"jTicietilsufficiertL • Ji13 Ji15 - 5.nuoro-Pn-2?5•Fluoro.P13-22 iiirmap-APf)increase APO AS APO loasicni Ji13 Ji13 • 5 APQ gufficienl 15 15 . AR-HJBFNArAAll,R113114ArA MflttSCincrease APQAPO S APO onftinicni • 15 . IS - ADB-PINACAAPB-PiyACA .ipgiase APQ 5 £Pft^ifTtsig!l II " liIS - < APO ?ufticicni 15 15 dpha-PBPalpha•PBP mcre.nciliac-sic APQAK) S APO sufficient 15 • IS alpha-PVPalpha-PVP i"""fincrease APQAPO • iS APQAPO sufficicnlsuffionet i li15 15 - APQsufTtdeni 30.000.000 30.000.000 • nmchetaiTiineamphetamine (far(far salclsale) ' iaaiaaftAEQiflaVAleit.EC1 lAM-tan1 807 6111(), APO Sufficient 30 000 000 301100,000 • APQ .iflicieni . 2jj&ooo 2. 150.000 AhEiANIT ieopssittor, 14.AEO'APQ' iJimaoI 12011(13,. APO sufficient 2.159.000 2.150000 - 15 15 buiylonebutvlone —inatase.e.D._jpof-"^ apo 55 APQAPO sufficientsufficient 15 • 15. - endeinccodeitteifor(foe sale!sale) ' incitrtcincrease APQAPO 25,501,000 . justified.mild. merestincrease APQAPO *36.000.00036,009000 39.600.00039,605.000 2,700,0902.700.000 ^ 1 00.000 tiihvdracodcinedatydruc.odeine iafitflwciactraseAPIIAPI"! lamaaIRO 000 • justify:1justified. increaseincreaseAPQ APO 81.10081.10D ' 181.100181_100 100.000 LSZififfi 1,020,000 - diphenoxylatedinherioxylate inrre.fgmere se APQAPO '. 740.000740_000 APQAPO sufficientsufficient 1.070,000 1.070,000 indifted. increase APQ 1.687,000 1.720.000 il00$L . fentanvlfetrarlY1 Jnticasc^EQ.inseMic.(5e0 940.000940,000 justified. incrcase_APO 1.687.000 1720000 52,000 79.700.000 79.700.000 hvdfocodoneCfnrlly_d recede n e am salelsalel ifiCrtlitG aeq;APO 32.3ft2.00Q32 107 OM frpOaPOsufficient sufficient 79 700 000 79 700,000 6M.QOO hydiomnrrilinnehudromomlinne Jarrm: Affl, ..,2> <»5SR'S AnnMO justifiedmulled, incrtiwinervim_APOAPO 5,000,0005.000,000 5600.C005 600.000 600.000 iarrenco.820 3.000 lcvornhanollevoruhanol iocimAincroim flPflAN) 5 650 justified,justified, increaseincrease APQAPO 2.705 $,7005_700 3.000 104,000 marihuana ,_._increaseincrcast APQAPO IQO.QM-MO 5504 - iudified,justified. increase.inceease_APOAPQ 21.00021.000 125.000125,000 • 104,000 • morphine ffor<(Tot conversion) . Jiuicaaincrrve APfiAN) 26251-OW76 751 000 APQAPO sufficientsufficient • 7371,000,000 ono 009 73,000.00073.000,000 riphvTfincr.inhvmrie increaseincrease APtlAPO i5 APQAPo sufficientsufficient 15 ' • 15 iiisii fieri. increase APQ 1 8700.000 28.000,000 9.800000 ' siw*mcoripayinc inennvcincrease APQAPO mm6231000_ indified increase APO ._18 200 000 28 0001300 9,800.000, oxycodoneommodone (for(for conversion^conversion) , in&raycj\POincir-tsojs PO 35 QOQ.QQQ,(100 000.„ _APQAPO sufficientsufficient 6,680,0006,680,000 <5O,680.680 ,000 000 justified, increase APQ 17.500,000 73.200.000 5.700,000 flevmojphoneomenombone i(foefor conversion)Callyersinn1 bflcasc;neve-ace APQA pn ..„6(\ IMti 1 ffOODm iustico. 4:roue APO • . 17,5ovoo 73.200.000 5.700.000 ^,200.000 . oxvmonihonemcvntorphone Ifor(for sale) - ,__inemiseincrease A£Q_APO 1 6QQ.QOO600,000, APQAPO sufficientsufficient 6220.000 _1_200.000 PD-22PB-22 _itatass_AECLirerease APO AS APQAPO sufficientpufPici PlutnbtrNumber of resistregistrants/entitiesrants/entities commenting: S PfumbtrNumber of drug*drugs commented on: 32 32 . . . . J3BEA Qnmiml Cnnmanv fnmmmT Amnurbt HesnonscResponse Pmnnsrrt A AN F.SUhlhh AAN Chiuipr.rhanne Number of reglstranK/entiriesretistran Wenders commenting:cornenenting: 0 Number of List 1 chemicals commented on;on: 0 Additional DrugDrue Considerations;Considerations: Rcaopnae PsyinntekaPf1 .folfl hi titled APQ Change Ikueflruti Remonse . IssntiltshrcLAE.(2 Chu= 10(1 / _3lfirclanilAfentanil indTMicincrease justifieditotifiedtmsrdbaaed nnon rfi'i-TTrnniremistrant_analicafiootanntifimtnnt lilfiQlkitn 14LL252 200_ 100 . • cocaine :; - intttatinerrqse iniifirdMoifind hdfftlbasectarijnerevedwi inciminl demand 192.000 220.000 .28.00028.000- S - 200 305. LJi 1/ codeinp-n-omdccodeinc-n-ocidc insfrarin-react iiiniiird'ossified basedhued nnon tcgiitncHleal151=11anolitatinasacalicaliaas 200 301,, OS • . AdditionalA d Inconel CtiemicalChemical Conalderationa:Considerations: ImpDrug . ' Resonnse PreinostelPrannaed.AAM AAN EifitliilialFleahlished AAN ThanrcChange , i.ooo.ooolv^ enhedrineephedrine (forffor salelsale) reviewed finalfilial A6NAAN for0'2911-20142(11 1-21)14. avp ofofAANAAN 3,000.0003,000,000 ±mm4.000 000 1.000.00e • - I . . • 2015201 S Proposed IrMalIniiat APO AAN CreatedCreaied by °DEOQDEQ oncn 5-844Q-6-14 Summary 012015ol 201 S proposedproposod initial commontscornmerrts receivadrcceivctd as o(84-14of 8-4-14 Vol. I Page 792 ' .» '« ' 4 v- (b)(4)(b)(4) •1 A ! y\ JulyJuly 31,31, 20142014 • • • V .• ' -r ' r ; ,• •: ' ' ActingActing-Deputy-Deputy AdinitiStratorAdministrator .? Drug Enforcement Adininisti'aticjnninistvat* alAi-gnfoiverneni.'Adi. . t .s. WaShington,Washington, D.C.D.C. 2053720537" .. ] -A .• • . . ' Attn:Attn: DEAPEA FederalFederal RegisterRegister RepresentativeRepresentative rDocketTDocket No.No. DEA-3931DEA-3931 ThisThis letterletter constitutesconstitutes (b)(4)1(b)(4) ]commentscomments onon thethe ProposedProposed InitialInitial AggregateAggregate ProductionProduction QuotasQuotas forfor 2015,2015, asas publishedpublished inin FederalFederal ReRegister t ister onon JulyJuly 2,2, FRFR Vol.Vol. 79,79, No.No. 127,127, pagespages 37772-37776.37772-37776. InTn lightlight ofof thethe factfact thatthat|(b)(4) (b)(4) |hashas nono knowledgeknowledge ofof eithereither thethe amountsamounts ofof anyany availableavailable aggregateaggregate quotasquotas oror thethe plannedplanned allocationallocation ofof anyany aggregate,aggregate, (b)(4)(b)(4) "[requestsrequests thatthat DEADEA makemake anyany adjustmentsadjustments toto thethe aggregateaggregate quotasquotas sufficientsufficient toto satisfysatisfy itsits requestsrequests forfor increasedincreased manufacturingmanufacturing quotas,quotas, whichwhich areare outlinedoutlined below, BecauseBecause thisthis commentcomment containscontains confidentialconfidential business informationinformation onon itsits manufacturingmanufacturing quotaquota needs,needs, wewe alsoalso requestrequest thatthat DEADEA treattreat thisthis entireentire documentdocument asas confidential.confidential. AllAll requestsrequests belowbelow areare statedstated inin gramsgrams anhydrousanhydrous basebase ("AA").("AA"). 83338333 4-Anilino-N-phenethy1-4-peperidinc4-Anilino~N-phenethyM-peperidinc (ANPP)(ANPP) (b)(4) (b)(4) requestsrequests thatthat thethe initialinitial aggregateaggregate be sufficientsufficient toto includeinclude itsits requestrequest forfor 1,320,0001,320,000 gramsgrams AA ofof 4-Anilino-N-phenethyl-4-peperidine manufacturing quotaquota forfor 2015.2015. ' 91209120 DihydrocodeineDihydrocodeine (b)(4)[(b)(4) [requestsrequests thatthat thethe initialinitial aggregate bebe sufficientsufficient toto includeinclude itsits request forfor 180,0001 80,000 grainsgrams AA ofof DihydrociodeineDihydrocodeine manufacturing quota forfor 2015.2015. 91709170 DiphenoxylateDiphenoxylate . (b)(4)b)(4) requestsrequests thatthat thethe initialinitial aggregate be sufficientsufficient toto includeinclude itsits request forfor 740,1740,000 t 1 gramsgrains AA of DiphenoxylateDiphenoxylate manufacturing quota for 2015.20 15. Contains Confidential and ProprietaryProprietary informationinformation Vol. I Page 793 ' *r (b)(4)(b)(4) RE:RE: 20152015 RevisedRevised InitialInitial AggregateAggregate QuotaQuota RequestsRequests forforKb><4) (b)(4) 98019801 FentanylFentanyl |(b)(4)(b)(4) ""[requestsrequests (hatthat thethe initialinitial aggregateaggregate bebe sufficientsufficient toto includeinclude itsits requestrequest forfor 940,000940,000 gramsgrams AAAA ofof FentanylFentanyl manufacturingmanufacturing quotaquota forfor 202015.1 5, 92209220 Levorphanol (b)(4)(b)(4) requestsrequests thatthat thethe initialinitial aggregateaggregate bebe sufficientsufficient toto includeinclude itsits requestrequest forfor 5,6005,600 gramsgrams AAAA ofof LevorphanolLevorphanol manufacturingmanufacturing quotaquota forfor 2015,2015. 91439143 OxycodoneOxycodone (for conversion) fb)(4)(b)(4) |requestsrequests thatthat thethe initialinitial aggregateaggregate bebe sufficient toto includeinclude itsits requestrequest forfor 3,000,000 gramsgrams AAAA ofof OxycodoneOxycodone (for(for conversion)conversion) manufacturingmanufacturing quotaquota torfor 2015,2015. 96529652 OxymorphoncOxymorphone (for(for sale) (b)(4)b)(4) requestsrequests thatthat thethe initialinitial aggregateaggregate bebe sufficient toto includeinclude Itsits requestrequest forfor 1,600,000,. $ I,0I I grams AAAA of Oxymorphone (for sale) manufacturingManufacturing quota forfor 202015.1 5. AllAlt other quota requestsrequests remainremain unchangedunchanged fromfrom [(b)(4)'(b)(4) original request.request. Sincerely, (b)(6)(b)(6) Supervisor, Controlled Substance Compliance (b)(6) (b)(4);(b)(6) Contains Confidential and ProprietaryProprietary InformationInformation Vol. I PagePage 794794 .• A"VA L ;1)1(4)(b)(4) ;1)1(4)(b)(4) JulyJuly 30,30, 20142014 DrugDrug Enforcement AdministrationAdministration Attention:Attention: DEADEA FederalFederal RegisterRegister RepresentativeJODWRepresentative/ODW 87018701 MorrissetteMorrissette Drive,Drive, Springfield,Springfield, VirginiaVirginia 2215222152 RE: Docket No. DEA-393 (b)(4) (b)(4) [CommentComment toto Federal Register Volume 79, NumberNumber 127127 (Wednesday,(Wednesday, JulyJuly 2,2, 2014)2014) Notices Pages 37772-3777637772-37776 FR Doc No: 2014-155492014-15549 Dear DEA Federal Register Representative: / ;b)(4) fb)(4) |herewith comment toto aa portion ofof thethe ^ above referenced Federal Register proposal.proposal, Specifically,Specifically, (b)(4)(b>(4> believesbelieves thatthat Proposed 2015 L Aggregate Production QuotasQuotas forfor ScheduleSchedule II andand IfH Congo11Controlled • Su stances and Assessment of Substances and Assessment of Annual Needs for thethe List I Chemicals Ephedrine, Pseudoephedrine, and PhenylpropanolarninePhenylpropanolamine forfor thethe listedlisted drug codes below may not be adequateadequate forfor the medical, scientific,scientific, research andand industrialindustrial needs of thethe United States. Drug Drug Code .' Codeine (-ic-;)(-fe") 9050 MorphineMorphine forfor Conversion 9300 OxymorphoneQxymorphone for Conversion 9652 Hydrocodone (-Cc(-frs")) 9193 OripavineQripavine 9330 HydroniorphoneHydromorphone 9150 Rc.pards. (b)(6)(b)(6) L Director, Controlled Substance Compliance Vol. I Page 795 . IMSIMS DataData 2(201-112014.2014 (es(est) ) 2 Substance 2011 2012 % Change 2013 % Change 2014* % Change Amphetamine (D,L)(D,L) 9,703.48 10,938.9810,938.96 12.73%12.73% 10,928.3210,928.32 -0.10% 11,781.2211,781.22 7.80% Amphetamine (D)(D) 10,594.6610,594.66 11,725.3611,725.36 10.67%10.67% 11,597.1811,597.18 -1.09% 12,428.0812,426.08 7.16% Cocaine 48.53 44.03 -9.28% 39.63 -a99%-9.99% 37.76 -4.73% Codeine 26,170.71 22,758.42 -13.04% 21,717.57 -4.57% 20,712.17 -4.63% DihydrocodeineDihydrocodeine 107.21107,21 75.02 -30.03% 36.22 -51.72% 4.33 -88.04% Diphenoxylate 462.60 413.01 -10.72% 406.21 -1.65% 387.76 -4.54% Dronabinol 110.82110.82 106.13106.13 -4.24% 110.93110.93 4.52% 115.72115.72 4.32% EphedrineEphedrine 1,535.521,535.52 1,973.121,973.12 28.50% 2,083.35 5.59% 2,175.64 4.43% FentanylFentanyl 539.85 575.08 6.53% 548.24 4.67%-4.67% 536.96 -Z06%-2.06% HydrocodoneHydrocodone 64,934.12 63,178.66 -2.70% 61,628.67 -2.45% 59,076.69 -4.14% HydromorphoneHydromorphone 1,675.271,675.27 1,912.791,912.79 14.18%14.18% 1,926.371,926.37 0.71% 1,828.211,828.21 -5.10% LevorphanolLevorphanol 0.32 1.541.54 378.02% 2.33 51.13% 2.61 11.65%11.65% Lisdexamfetamine 12,336.1812,336.18 14,001.3014,001.30 13.50%13.50% 13,653.6613,653.66 -2.48% 14,195.7814,195.78 3.97% Meperidine 2,303.07 1,885.751,885.75 -18.12% 1,537.431,537.43 -18.47% 1,296.651,296.65 -15.66% Methadone 7,639.42 6,776.37 -11.30% 5,804.95 -14.34% 5,358.57 -7.69% Methamphetamine 13.8613.86 14.4014.40 3.87% 13.0913.09 -9.11% 12.3312.33 -5.82% -8.12% 17,989.12 0.22% MethylphenidateMethylphenidate 19,212.6319.212.63! 19,534.8919,534.89 1.68%1.68% 17,949.1917,949.19 -8.12% 17,989.12 MorphineMorphine 30,435.83 28,705.57 -5.68% 26,267.70 -8.49% 25,007.07 -4.80% Nalbuphine 61.42 63.63 3.60% 42.05 -33.92%-33.92% 39.10 -7.01%-7.01% Naloxone 391.27 430.32 9.98% 478.98 11.31%11.31% 502.16 4.84% Naltrexone 4.56 0.00 -99.98% 0.00 -100.00% 0.00 0.00% Opium 84.96 81.02 -4.63% 77.44 -4.43% 76.79 -0.84% Oxycodone 70,885.8270,685.82 66,7031466*703:74 -5.90% 60,313.66 -9.58% 58,971.27 -2.23% Oxymorphone 2,655.74 1,958.251,958.25 -26.26% 1,865.591,865.59 -4.73% 1,936.851,936.85 3.82% PentazocinePentazocine 839.71 698.43 -16.82% 563.20 -19.36% 412.71 -26.72% Pentobarbital 79.12 46.62 -41.07% /7 24.25 -47.99% 22.90 -5.55% Pseudoephedrine 104,476.73104,476.73 93,933.95 -10.09% 93,208,9493,208.94 -0.77% 92,381.64 -0.89% RemifentanilRemifentanil 1.051.05 1.111.11 5.83% 1.161.16 5.10% 1.211.21 4.14% Secobarbital 20.78 15.6715.67 -24.59% 11.9811.98 -23.55% 11.2611.26 -6.01% Sufentanil 0.05 0.05 -2.53% 0.05 -7.93% 0.04 -11.50% *Estimates•Estimates based on JanJan-Jun-Jun 2014 DataData Vol. I PagePage 796 BasicBasic Class;Class; 70152015Initial InitialAPQ APQ'' rw Itti FDAEsi: 015 TotalTotalPQ PO R-Req.q. 326.100.000326.100.000 FDA Est 015 imsIMSe»t Eat -.021-.021 (used(usedfenlamjl fenlarryl111%) SJtaro bt 20 IS Tacal PQ 20 13 Inventory 2014 Projected Eaporta 2014 Projected Saloa 2014 Projected Inventory Adj Avail Cafe MQ CompanyCompany OEANumORA Num 2C1S2015 RequealadRequestedMQ MQ 20142014 RaisedRevisedMQ NQ 20132013 SaksSales 20132013DEA OEA MQMO SalesSates f,5G <*3013of 2013 S-lesS.411 Saar* o12015 Ten! Pa 2013 Inventory 2014 Projected Exports 2014 Projected Salsa 2011Projected Inventory Adr Avail Oak MO 1000 326.003 73? 210,631.000 0.000 1.20S.1&.M0 52Q.039.000 830.123.250 530,123.250 (b)(4),(b)(7)(E)(b)(4);(b)(7)(E) 1.1,320,000.000320,000.000 1.040.0001640000000000 777,062777,962.000 000 777,876717,8)6640940 1.000 128,093137 210,631:000 0.000 1,205,129.000 520039.000 939,123.250 536,123.250 c.ooo 9000.000 4,105.200 4.920.00ft 4,020.000 13.50013.500000000 6.5600006,560.000 0.0»0.000 777,876.940717,976.940 0.0000.000 00000000 0.0000.000 0.000 6000.000 4,105.200 4.920.000 4,920.030 943.043.250 KqMO Totair.Totele. 1,333,500.0001,333,500.000 1,046,560.0001,046,560.000 693.043.250 20142014FlMl Final InitialIn16a1APO:APQ; 2,150,0002,150,000.000000 30142014Final Float Revised APQ:APO: 0.0000.000 FOAFDA Eat:Eat (2014{2014 tnWllInitial APQAPO'* 1 • FDAFDA E«t»:Est): 2,162.2500002,182,250.000 IMSINS Eat:014{201 {20144 1nWatlnItlatAPQ APO • 11* IMSIMS EctJ:Esti: 2,10S,710.00C2,105,710.000 APQAPO •irffieiasuffieknt,M, nono aadjui djustfuerdtenant requited required \ 4-ANILINO-N-PHENETHYL-4-PIPERd'ANILINO-N-PHENETHYL-4- PIPER . Vol. I PagePage 797797 Bilk;BaskCtaaa; Cuss; /....g14) 2015MUialAPQWc2016 /01.6a I APQ Wt FDA Eat: . nta ToWPQRequ.Tala1PO Ram., KM.OOOIGLOOS FDA Est: , Na iMSfilt:IMS6it: Share of 2015 Tela I PQ 2013 Inventory 2014 Projected Eaport* 2014 Prejo clod Sales 2014 Projected Inventory M] Avail Gale HQ CompanyBuoyant, DEANumI015R*qo»a1«dMQDEA Num 2015 Priumftel MQ 20142011Rcvltod Ras1144HQ Ma 20132613Sale* Saks 201320130€A DEAMQ MOSate# Sates *of2013Sates%o{ 2013 Sales Share of 2015 Total PQ 2012 Ifsvamory 2014 Projected £spoor 2011 Projo clod Salsa 2514 Projected Invorrtory 0.4.1Avatl Cale Mel oooo 0.000 0.000 0.500 1600 1.SOO 1.500 (b)(4);(b)(7)(E)(b)(4),(b)(7)(E) 2.0002.000 22.000000 C.OCO0.000 4,636.0005.830.000 0.0000000 0.000 0.000 0.000 0.500 1.500 1.500 1,500 104 000 6.937.000 0.000 13,760.000 6.916.000 1 7.262.740 0.361.000 14,100.00014,100.000 14.06011.640.000000 S.63C.OCO5.836.000 5,636.0005,838.000 11.000000 104.000 8.937,000 0.000 13,700600 6,936.000 17,262.750 0.361.000 9,162.500 MQMOTotal*: Totals: 14,102.00014,102.000 14.08214.062.002000 9,362.500 20142011FlmllitWMAPQ: Final Inklal OPQ: 14,100.00014,100.000 20142014Final FlnalRsvUed Ra vim dAPQ: APQ: C.0M0.003 FDAFDAEat Est[2014 12014Initial Inkla1APOAPQ' •1 I.« FDAFOAE*1): Eat): 14.1O0.OC014.100,000 IMSMSE*t; Eat(2014 (2014001NitnHlal APG APO`' 1 1 • 1*5MSE«); 6a1); 14,100.00014,100.000 20157015 EalsbliahEatablishAPQ: APO: 14,200.00011,200.000 20162016Eatabfiah EstabtahAPQ APO with25* 25%buffer: bolter 17.75000017.750.000 ALFENTANIL Vol. I PagePage 798798 BulrEtuk Clatft:Ctass: 30152015164141Initial APQ APC1Wort<*h«ota Worksh0016 FOA £ftt: TotalTaw PC.PC R^jiML44.luta,IL. ' 25.734,229.9*026.734,226.942 t"."11111) 112A Est: • 04 / IMS116SCat 0411 0 Calc0.16(JahiQ UsingCFIt 04R60n; 60% CoaiyjnyC408449•90v DEA0E4 Ui*nsatn 2015201s RequestedRequesoselNO MCI 201*2014 RevtSedPosm•c1MQ MO 3013S*ki2017 Sal. ?Ol32013 0£AMOSa»o*IDEA 140 Saks *«420l35ati*% al 2913 S . 5hai»<*Sham 4420152015 T©UITotalPQ PO 20120131arantory3 Victory «*U2311Prc,««*»d Projected Exp.,1 2QU2011Projected PraiactadS.W>* Sabc MM2011Pr*^«c4®d PrcitasedInventory a...46264y AdjAv*'4C**cA4i Ars1 Oak v...”1 WO1.4.0 C.000 V.500 ofloa 5.000 lOOO 5.10Q -O.Wfl 50CC (b)(4);(b)(7)(E)(b)(4) (b)(7)(E) 50CCsOCO 500Q5 330 OfiOQOw7 24.011.115.52526011.100526 0.0000.000 0.000 1070 0.000 5.000 48100 5.100 -0050 5000 odoo 25 000 <04 004 IQ7.Q20 -91.456 10ODQ0100000 too100600coo 1.0391.019 25.0126.011.1743201 .1 74.526 O.DOO0.000 1,1461.144 43.59140.693 0.600 26.000 1a1 WS 101.020 -91.458 100100.800DOo 556 £70 600 D.OM 0.030 SM.670.toQ 555.670.0C6 535.00567E096000 COO 0.0000.000 0M30.000 26.6*26,011.178.5261.174575 00.000000 COM0,1700 a.0,000ooo a.ooc(LOW 556070660 O. 0.030 554,670.033 Ss:2020_00C 296.600 000 2l4.197.00O 453«23?.7S0 -124.104.541 296.0OO too 296.000236.000OOD 003 146.OOO.Q0O140000400 106,657.006106,667.000 20.011.124.011.17632675-525 6.06*6.604 1117,615.227J 7.631.127 430,397.000.93.797.000 o.occ0980 216 .000 000 214.197.000 457297.750 -124.104.441 296,000 030 3.592.1 MOM 13,737.672DM 12.624.442221 1 1.600,000 Ooa 11.Q0C.O0Q11.60C.000000 000 13.145,613.60013,145,612_0073 1i.022.449.OM12_022,441.030 35.011.17552526011,170526 0.4620.462 11281,05197713,281051377 S.175,3712510001 261.000 150.220000150220000 103010,200400000J.4M.000 5,092.152000 11,737,67211)0 12,624412221 11130,000 1100 8.923000 000 16.369.123.750 19301.036698 10.303.026658 25,501,00025,501,300 000000 17231365.00017,231,565.000 13,120,41913,120119.000000 25.011.17552616.011,171,526 0.5065_505 14,548.200.31811,549.200.95! 5.127.J0O.DCO5.177600000 OOCti0006 19,1(5,000.00019,160,8490.000 8.923W3 000 16269,571150 19.1018226.698 10,303,024596 ' 0.006 730.600 231.537 I.OOOCOO1,000000 1.000.0C61000,110 1.3301.730 26.0126,0111715241,170.526 OOM13 000 1.4691,461 O.tXffl0.000 ODOO0 300 1,000.1,0073030WO '0.000 750.000 251.617 I.OOO.OM1.000003 147430 000 1,9 16.1 83D60 7.M4.4W657 J. 544 ,490.857 4,915,0000004,915,300000 2.J54.9U.OOO2.954.311.000 J771,641.00011.541 .000 25.011,1752&011,170576525 Q.0270027 786,141746,141.066DOS o.oco0,000 00000030 3.3.478603.1004 78.000.000 147130 000 1,016.185_503 1,514,490.657 2.544,190.657 34.303292-W9 MQTotab:140 Totals: 43.151,16300043.141,163000 33.05133061,197.030,197.066 14.303292.551 MUFku1kUCi«1M'Q:2011 rirw hiiN PPCX 36.9to.O00.00O36.900.000.003 20142014 FWU*raft tevi£«dRevisad*PO:AfQ: o.ooo0.000 FDAFDA 830 (2D(201414 klttk)Ink101APOAPG * 1 • FOA019146141:,£»t): 35,42436.421MG.OQO 000003 IMS0/0Cat Est |M1(20114 WfcilIn70-11A1 APQ110 1' 1 • fMSOAS BUJ:Est): 1531111600JQ2.606 COO000 MH7011Proposed PaNkssed167112111PCtInitial APQ: 16.900.C0616,906.200.006600 70iaj«Ubli5h«d2011 rtatArshedAPQ." APO: 19.600.006.CDO19.6170.000009 2*rfE*tabU«*»0Eststids1.1APGAPO ytlVSat 710: bvflerr 49.5M.OOODO049,503.007400 ZOlSavt,201 APQAFC( ^juatmeSHaMI t*4sad oaonHofttnco't 01664.4000's iocfttt*4incr. es-ed*«£ort •Azort requlrmwiu COO6lNE APPLICATIONAPPLICATION FORFOR INDIVIDUALINDIVIDUAL MANUFACTURINGMANUFACTURING QUOTAQUOTA Request IP.111.11202681120268 batebate SubmittedSubmitted' 3131-JUL-14-JTJL-14 Sana..KAMP of01—BnflicBaalc PlanaClass aror t.IatList 11 ChemicalChamixall (oz].fonlv 11 Mlner DBA-mu -189]18 91 0 caPECHECOQEINE (FOR SALS)SAL£1 sghaduIe/LlatGchedule/Liet Muabar.NUMber 0 c fameName and AddiflaaAddreas p*of Rsgl«ygntRaoiatrant _Prucr...CodeDrug coda 9050-B9050-8 (b)(4) QuotaGuota YearYoar 201S2015 PEA RegistrationRegistration NusibeiNuraber(b)(4),(b)(7)(E)(b)(4);(b)(7)(E) contactContact _F.eraaaKb)(6) FermORW(6) FaFax.a, Ngtry (b)(6) gmAilsail M Ifrf the Purpose is to Manufacture AnotherAnother SubstanceSubstance(s).la) . Furnish the Following Information:Infexwation: HbmWeft. ofet f««New SuhotanceDuhatance Drug AmountAmount qaadCoed torPox...thisthie PurposePunka o \S Yield 2012 ~~I1 2013 I' 301S2015 1 Productpesasct Development DoaigaDosage TomEons 0Strengthtrength tfnlti/flatchVaita/Match •1 of.e BfcCcheeMacchia Batch Purpose E«t.Eat. Quantity [Eat,Eat. Completioncoopletion ?imoTime c Transferrr^ncfgr A»gl*tr*nt|Aegiotrant F ------ExplanationExplanetien Ofed r*Tranafarana fat • . DateData of PeatDestruction/ruction | Explanation • Packaging Product NanaNone Strength UnltD/PXgOhlto/Prg I If of pkgaAkso i Purpose J Total Quantity AeaarkaRemarks productionProduction lossloos estimated at 2,291.0002,291,000 gramsgrame 1,000 gramagrams to support reference standard business Replaces ApplicationApplicaticn Reference4Reference# 119691U3691 i 7? • LORIZDf<( sportski epo s ---~ iI )>7 7y7> 6_0(64.A(jxfeo^A ^w\k'(faC1 .V061,C.:- z()to IA t-i es«£St-t_ e-A/ --r (Q^ooo 000 to\5 Q.__ '"... . \ --I's:J.-- • it) \ 5 -eizi-3' -, --4- 1 qg z.l% \ 1 9 • 4ki..v:_,1 II ' _.= •JI- e,irpt)11:.. k-V OVACCoWvr<£.....) c 1\ % \ 1-4-1 Vol. I Page 800800 Codeine fromfrom PT vqukemenliequi4emenis r".111) 4 runalInitial ltl201114 101410U QuotaQuote CrmtGrant CoitimtntComment 2020151 5 Quota Apr-Apr-IS1 5 Au[-l5Aug-1S DollDelia a CommentConitornt CPS-ACCPS-ACAA *.2906_290 1 CPSCPS-ACA-ACA 73007_500 >5.03075.000 73007.504 • Co5IXo3cMiT75rT3Ictotal t..od..in; .10, 2, 1e Iniijalinniel groigam, 17.231.56517,23! 365 TuU)Toed CodeineCadotn6 for Sale;Sale: 25.5«'^825.5001:0 CodeineCodstnt FarFor SaleSalo (frolfro*|(b)(4)|CPS) (b)(4) Ps) 4,9714971 0g3kgB Codeine For Sale 5.700 11,00011.000 S.3QO5,300 '17147.1.7Codtiate2014 (b)(4 ) Ced(i«i< EbotyltalcPboipbalclnventorj grontstry 1With11/th CSTcnlCaartnni 20120154fbWjc b)(4) Codanns!odcine Phosphate Inventorygar ntory CakolarrontCakolariont QnUQw•i CalculationsCalculation* 2013 EndinlInvadorx.Kndina Inventory 2,522 2014 EadmnEddinA InventotyInventory im2,135 NonNan saleablesa1c...71c maigna]macer.1 U12 NooNon aleabkralcaldo miletrgenalnil 0O 70172015 MailableAvail4b1/ End.fal In,In*. 2,5105,550 2014 AvailableAveilabh End. Inn-Inv. 2,1352,1)5 4,071 11,0001 1,060 2014 API QmQuotaou 4,971 1015 API QygiaWt. 4- 2014 DispositionsDiggothfaiy 20|5Dii«ni?ions:2015 Ddrov:ions Sale*Salcs 4,7554JS5 Salt*Sales 7,992 Procc54w&Pro“ssin,g, U»gLosses sm(592) Praccasipy,Proccssiet.1,teesLo**« 1.,276) ZU142014 EndingEgfag InurnasayInvenlory 2,1352,153 1015101S Ending ravcnlory7.•cotary 3J4T521167 CaavertedCenrelied igon %%YearendYearrnd 59.9% Converted:Converted toro %7/. Vearendl'nantnel --.6 60.7% kgt,512,1hate"lr kgt,8gs, baicIn 2013 Diipo5ilicmi_Disposition, 2.1102,300 10142014 Eg.Est. DispcattoniDisposition, ±2114,75% 201421514 blEst. Disposition*Cbsporttions 4,755 ;0I52015 E^TEst. Pispomk>«DiNpacitioas 7.9927,992 _ Airra^gAverage 3.5675,567 AveAveraget&t 6.37?6,173 W/»50% InKnlarf[memory AlUwunrAlt...tut., 1,314 $0%511'A lovgniqcylortntory AllowanceAZ:mu:mg 3.117 ACTUAL YEAR TO DATE (JUNEJUNE30,30, I014)101 4J ESTIMATE UNO.N 101530LS Q"X«q..4. C*leCer NetrO output Lot*LOS, by Inputinput toto OutputOi.dpus Lai*L.031 by l»p*lawol lloa PrtttelsF»W«l NetAlel •utpnHgavial Description [»prt[mind toio SupStap Pr«mP rarest YiddYield qfof steprot; _ _I<2_Ow StepStsp of•fNtepStep fltprep DcwiptionPcwiiptioc StepStop ViddYield , pTof air,tlrp boasLo« by stepslop CPS.ACACPS'ACA toto CodeineCodrinc for SaleSalc 18251,825 1454 1%I'/. 1,535L535 4,0154,005 33.456476 CP5-ACACPS-ACA .7to CodeineCodotno forfor SaleSalo 13,07513.076 #4ga 1% 11,200ll.COO CodeineCutItint forfor SoleSale Code***Cobela torfor -Saleftale Codonts(ftCodcineffe CPS) to CodeineCodeinr Phorpbr,Phosphate r 122L1,211. »,.s65.5%% 1.079L079 114"%1145) 2,653 3.4315.03E <44>]4-4-4:) Cudeuv:(&Cotour:(8r CPS1CPS) [gto CodcincCodeine PhoiphatCP6o:phate n.ooo11.040 #1.5%66.5% 9,740 tl.Xl)'1.1, 6) Codeine Hios?Vi*gPhosphate Finished _ 995%99.6% O0 *.51?4,517 4,5451010 <7jClt CodeineCndoinc PhosphateFbosphatoFiaishodFinished 9.740 9991 »%8% 9.724 1(1411 A? ToTotallal 1140U4o| 4.132i Total q.77tQI L.7751 xVZ^ I *-3 -kl With Current I011J0LC CPS-CodimclnvaitoryCPS-Coo:Niue 1natation , CtkbUtioiUCaltoltltotts Qn*1kQama 2015 CPS-CodnftfCPS-Codrube levfulory1 e4ttulony CalculationsCilrutnions ZD2013I j Ending;Ending IntInventory onto, 1,867 2014 EndingEnding Inuceno,Ir^catcry 12iZ2,247 NooNon alcafclcalcakto malenalrnatcrla/ NooNan tilciWotalcahre materialremenal 0 \Ti 10132013 AtiA•ailablnilabl* End. Inv.Inv. 1¢671^67 2014 AvedaMeAvallabk End-End. Inlav-, iiil2,247 2014 API QuiQuayou 6.2906,290 2015 API QuoLiQuota 15.00013.000 2014 DispoacoayDispositions. 20201515 DiipontiiDirpostriens - ConvertedConvcdstf toto ACA fixCoo Sale 59100,910 ContortodConverted tokr ACA fa/for 5?lcS81u 13.076_,13.076 :0120144 tiding InwgtgfV U*L2,217 1015jQ15Ejidin| Ending larefltcrylard/tory 4,171 ConvertedCoonr.ss1 to % Yearend 37.9%57.9% ConvertedCuorortsd toto Va58 YcHYeti endond <39%45.97. kg'i861, batsb'" _kLjIb™kit, base 2Q132013 Disposition*GnposIttors i.WI5,941 30142014 fc:Ed: DitpoptionsDiipoHtipo* 5,910 2014 farDjiggfllitetEs: Dispdedioes 3.9105.910 2020)515 Er.Est. Dny>qtk>tuDirposItaria I3.C176131175 • 9,493 Average 5,925 Average Ill%3u% Inventorylavrwtory Allo—aarrAllow., i™1,775 1530%% IntnutoryInventon AftoiAtl•wanco 2.8412,811 2012015S Fo«ta*lF. ort cast TUT? Total.Total, beto 2015 OoWooierOntonier DEA*DEAD' Salt ,Toid,bRBToi al, ke3 'b)(4)(b)(4) EXPORT 8.03700000 5,920 EXPORT 2.0CXJ2,0(51.1 1,06nMEO EXPORT 600 444441 EXPokEXPORT i ZOOzoo III141 ->3qQ\L,0(\.n ? io.to<10.000 im7,992 ->3qovO^vA = n ? ^ ' l uq C\r/r IXC - %it:7'7T ) n. \ Pagepage 1 1(b)(4)(b)(4) Fonfldenilaleinficlential 7^30/20147/30)2014 -2-\ _\\sm Vol. I PagePage 801801. 2- 6~, / `1°to CodeineCodeine Fromfrom P.It /41"11)ltequireMentSequipments loitunouInitial 2014 AdditionalAdditional AprilApril TujuTTAugust Delta 20|4Quoia2014 Quota GrantGrant 20142014Grant Groot CommentComment 2012015S Quota Quota SubmissionSubmission regionrevision Delta CommentComment 1^.395 (2.60?) MorphineMorphine foarCgnwigonfor Conversion forfor CodCod forfor SateSate 10.43110.431 14,14,501<01 MorphineMorphine forfor ConversionConversion 23,00022.000 19,395 0.6051 6,855 6.855 MorphineMorphine forfor ConversionConversion forfor 14-HM14-HM • 00 999999 MorphineMorphine Torfor ConversionConversion forfor 14-HM14-HM 00 6,855 6,055 23,000 26,250 4.2SC TotalTotal MorphineMorphine forfor ConversionConversion 10.43110.431 1S.5P015,500 Total,Total MorphineMorphine forfor ConversionConversion 22,000 26,250 4,250 TotalTotal CodeineCodeine forfor Tool Codeine fot Sale: SaleSale InitialInitialgram grant Total Codeine for Sale: 25,500 kgB CodeineCodeine Fotfor SaleSale (from(fionsMorplune) Morphine) 12.26012,260 17.231.56517.231,565 k*BItstB CodeineCodeine FotFor SaleSole [9,00019,000 14.500 w.JQfrt(4.5061 25,500 kgB 20201dillorphine14 Morphine forfor ConversionConversion IInventoryaventory rawiInitial 2014 - K3Additional CalculationsColculstions GrantGrant 20142014 GrantGreet 301S2015Morphine Morphine forfor CoPVtrilonCatlYtedidl InventoryInventoryCalculations Calculations 20320133 EndingEndir.g Inventoryinventory 2.4542.454 2.454'2.454 20142014 Endingadult; InventoryInventory 2,8332.833 NonNon saleablesaleable materialrnaerial 33 33 NonNon sakabksaleable materialmaterial .. ., 00 ZD!20133 Available Available End-End. Inv.Inv. 2,4512,451 • 2,4512,451 20142014 AvailableAvailable End,Eod. lav.Inv. 1.8332,833 26,250 20142014 APIAN QuotaQuota 10,431 14,501 20152015 APIAPI Quota 26,250 20142014 Dispositions: 20152015 Dispositions;Dispositions: Converted toto Codeine 13.12013,120 13.12013,120 Converted toto Codeine 15.516 ConvertedConvened toto 14-HM14-11M 00 999999 ConvenedConverted roto 14-HM14-HM 6.8556,855 Proc^svjiE Losses ProcessingProcessing LossesLosses - - Processing Losses - 20142014 EndingEnding InventoryInventory -238-238 2.8332,833 10152015 EndingEnding InventoryIenenlory 6.7126,712 30.0% Converted toto % VearendYearend -2.2-2.2%/. 25.8%25.8%. ConvertedConcerted to%to % Yearend 30.0% kgr,kgs, basebase Ikpa,tt*} basebase 20132013 Disposition*Dispositions 7.6":;7,872 - 20142014 £st.Eat. Dispositions [4.11914,119 2014 Est.Ert. Dispositions H.H914,119 2012015S Est.Est Dispositions 22,372 Average 18.245 Average 10,995 Avenge 18,245 9.123 SQ%50% InventoryInventory Allowance 5.498 50%50% InventoryInventory AllowanceAl/owarwe ..,_ 9,123 •mrW101 2014CodeiM2014 Codeine PhosphatePlico plate fromfront Morphine CurrtalCurrent 20152016 Codeine PhosphatePhovhate fromfrom Morphine Inventoryloveolory InventoryInventory CalcnlCaked a hongliO.S QuoiaQuota Calculations . 2013 Ending Jnvefitory'inventory 2,644 2014 Ending InventoryInventory 2.747 NcmNon saleable material 26 NorNon ukablcsaleable material 0 2013 Available End. Inv.Inv. 2,618 2014 Available End. lav.Inv. • ^472,747 2015 API Quota . 14.500 2014 API Quota 12,260[2,260 2015 All Q1101.1 . 14.500 2014 Dispositions: 202015IS Dispositions: SaksSates 11,360 Sales 11.176 Processing Losses 22(772a Processing LoSvesLostts iLmi(1,015) 2014 Ending Inventory 2.7472,747• 201S2015 Ending InveoloryInsectary 5r0S65,056 Cefivtrttd tr» % Yrarend 44.9% Converted toto % Yearend 24.8% Cooverted to % Yearend 44.9% Icy, base Igt,hes, base 2013 Dispositions 10,761 2014 Est.Est Dispositions 11,36011.360 2014 EstEst. Dispositions 11,36011.360 2D201515 Esl.F-st DispositionsDispositionS 11,176 ' Average 11,06011.060 Average 11,268 S Page 1 (b)(4)!b)(4) ;onfidentialonfidential 7/30/2014 Page 1 Vol. I Page 802802 Codeine Ffomf*From M Hiequiremcntsequiremtrits 4 T.611ESTI MATE ON REMAININGREMAI NI NG ACTUAL YEAR TO DATE (JUNEMINE 30, 2014) QUOTA IQISQuptaCatc2015 Quota Cole Input coro Net output LLenzcat by InpdtInput toto Output of Loss by NetMt output oforI-oss J-*ss by Description Step Process Yield MWCAINVC of atepstep Hepstep StepSlcp Step aiepimp DcioiptionDeseri_p lion Input toto Step Process Yield MWC step . Hepstep CPS -AM-AMAA toto Morphine foefoe CowCons. 7,6527,657 SS.60%85.60% 66646,554 <.5294,529 3,8762,876 CPS-AMACPS-AMA toto Morphine for CoovCons. 30,666 85,60%85.60% 26,250 Codeine for SafeSale Codeine for*for SaleSak LOS 14,500 MocphiwcMorphine for ConvCons. loto Codeine foefor SafeSale 7,478 890%89.0% 1.05i .as 5.9866,980 5,642 mi5,272 MonvbineMorphine for ConvCony toto Codeine for SaleSalo 15,516 89.00%89.03% 1.05 14,500 ,-- (923)MX) CgdgncjjrCodeine( fr Morph)Alcirt9 toto Codeine PhosphatePlios-phete 5.220 93.60%43.60% 0864,880 (334,(334' 5,7755,'ZS 5,406 . i',nt(3701 4 ,cocIcinc(frOxkincifr Morph)Monthl toto Codeine Phosphate 14,50014,800 9393.60% 60% 13,57213,572 Codeine PftcsphatcPhosphate Finished 5,114 99,36%49,36% 5,081 1CPI33) 5,490 1,4555,455 (33:ras; CodeineCodes,? PhotohatcPtioi phptc finishedFinished 13.572I3,572 9936%49.35% 13,48513,485 (87(17n1 TotalToUl (357)CM) 110511105) Total 11.015t(1-0151 20IS Forecast 2015 2015 Tatar, It*kg Total, CtalotnttCustomer PEADEA «it Salt 1*BligR , CommgntComment , (b)((b)(4);(b)(7)(E)4):(b)(7)(E) 1,900 U06±L 1,340000300 1222226 HSHY 158 117 v A 300 222 ,..-1" 300 222 ' Include,lnclu4a StS<&2-^ ~2^1) GeneticGeneric ZSzsm- ,4- ns SidcoBidto ZCOS-4-) 1\Sl\ 12,10012.100 8,9540,954 BG0J40115AC0360115 tokD,C41,02_, mjiT- 45 33 — Total 15,103 11.126l 1, [76 . COMBINED CODEINE INVENTORY (TASMAN AND MORPHINE CODEINE) I 7,58 TOFWith Current } ems? 2014 TotalTorii Codeine Inventorylove biOry Calculations Quota 2015 Total Codeine Inventory CalculationsCalcidations 20132011 EndingEndes, InvcnioryInveniort 5,166 2014 Ending Inventory 4,882 KenNon Itlcablesaleable rmlcriaJ=retied 38 Non,Non saleable material 1I) 2013 Available End. Inv. 5,1285,121 20142024 Available End. Inv. 4,882 20201414 API Quota 17,232 20152315 API Quota 25.50025,500 2014 Dispositions;Dispositions. 2015 DigDispositionspositions:- SalesSoles 16.11416,114 SaksSales 14,16819,168 Processing LosiesLosses _ 0.363)(1,363) Processing Losses (2,291),(um 20201414 EndingEndirty: InventoryIrnrculory 4.5BZ4,882 2015 Ending Inventory 8,923 Converted toto %'I. VcarcodYearend 33.4% Converted toto % VearendYearend 50.6% kitkg's, bajcboar kgs. base 20132313 Dispositions 13,14113.141 2014 Est.EST_ Dispositions 16,114 20142314 Est. Dispositions 16,11416.114 2020151 5 Est. Dispositions 19,168 AverageAvcrapc 14,62814.628 Average 17,641 SQ%SO./. Inventory Allowance 7,314 Sft%50% InveInventorynfflry Allowance 8.8218,821 -4«£ L.m o •q- \ ^ (b)(4)!b)(4) Confidential 7/30/20W7/30/2014 Page 2 Vol. I Page 803 V S 3 J 2 [ « * Saa. CI4s4:J 2015 00.0.1 APO Workartetrs J § J I i 8? I ,r Total PO RoqualL,S 9.113.000 049 Esa. * « « | 5 " Stun,a of 201S Cok llama coF 2 » i 3 j si r ! 5 * s I ? I 1 I i 8 J if 1 I S 8 rv> f 3 5 is I* S 8 s s 3 3 I ( J ° a I m S § T E 6 I E.lste Projected imam CO Istalot3 SPA tram 2015 Parposted Ma 2014 Iliar1444 MO 2013 Stns 2313 DEA MC/3a1.. %ot 2013 54144 Total PO 20133..434y 7004 Prop9stal Esparta 2014 Palraltal 5404 2910 Projected 2014 traentay Aisj Avail Clic 50% MO - § § §8 s" o o 8 S f § o A a000 0.000 • 4.000 1 750 1250 m? 7.900.704 ospoo &DX CT . 5011 5000 0.072 0.000 3000 5000 "5 ss (b)(4) (b)(7)(E) . * 8 5 § OOP y 8 i o i o O v? 5 000 5„ CCO 0 764 2.90.7134 0E00 0 872 IA 945 0000 3.000 0.000 05.946 14 959 .14 606 5 OM 3 2 § IS I § v, s . : 1 u 8 o — 1 v ? •2 § ** 100,000.000 soma.=I 7.507.coa 2989.764 1000 9,100.950 202,423.000 COCO 184.250.020 0000 422,917.000 21t.917.250 46.794 265 107.283 Igo 8 p 8888 SH--8 SHs § 5 OOP91 «» gills §§§§ §s §18 B8B8* 8 K §151 = a nt'tf 1 o BB88S s fills •** § 1.007000.-I 250000 0.200 7.088.764 0.000 0.228 136960 0000 1,000 000 coop 0.000 290220 . 675.025 67502-8 3 I I I 2 s 1 § I MO 5trtafs:! 181,010.000 50.260.000 107069 613 § § 2014 43t4 InIttal APO; 00.600.000I p § 2014 Pl.naa Ravls.or APO: 0.000= S i I FDA 64t, pa 14 In141•1 API).1 • %Oa Eaty 80500? 000 S £ in § §§ 35 : Mil * Ii Itol Est Mu liji 54941 APO • 1 . MS Et* 80500 000 S § I i | 5 § § " 2015 Proposali E*1400415 APO: 01,000.000 •• s > 2015 Establishedi APO: •81,100.000 B Si H I as With11 35% beta; 726.375063 i Di1 -011DROCOCEINE I o 03 CD CD 7 Vol. I PageCQ 804 /1 .111, 1) e»«c0.510 cu»:015"; 20182012 Inrtllt1414051APQAPQ iN045506514WortihMf* T.MJ1T01.5100PO Req..,Gfcjufl«v 1lOOO 000 r°48114)1 IRSi»se#c Esc -0 S*Jro55.5ro 4*2013es< 2015 CA\cC.4.16 u«lrvfl1.5.14.0 CfflCFR 50*5401 Eaporla 2014 P05)ociod Salus 2013 ProuotAu Elport4 2014 51544.61.4a1mmukuy 11.1)015.110406 InvOldIrwOAt *aMCI CompanyCoi^pfWtf PeanutDEA Num JOlS2055 ReloctR©*t*1if«1,A1 MO 3014ft»¥** MOTotott:NO To130: 771.652.000 909,002909,0)2 000 76OC8.7S070 4.508.950 2014 FlMNflMMF16411611141/ APO;APO. <00.090.000600,000.030 2014201,1 FlMlRovliidF16.1115951540 APQ:AFC: 1.0J1.0M0001.02 1.0.20 000 FDA E»CE oC l»1(201410.1114.14 InHlal APO •' 1 • FDA£»1];FDAE.511, SCO600.000000.000 000 IMS1145 £*tCat 12814{2014 Initial64041 APOA.P01 ' 1 .• IMS111.5 E«i|:64, 1: 572.760«B572.760000 2012015S Proc.0.10Propo**! EmtaNish ApD: 1,031,¢5,1001.03 l.aoo 000 APQAFC) ufrta'nat,falTkiell, no adjuktmentrsqltddaelu•tenent moulted DTHENOXYLATEDIPHENOXYLATE (FOR SALE) Vol. I PagePage 805 c r r --Ws) a w> 5 1 s «» I If ° a ..1 001111 APO 2015 WOrlif w Basic Claw*: .8 M £ CO S | s 1,007,215233 FDA eat:. .015 70141 PO Requ. u/ Lrw) «• 118$ Est: -.02I u « - 8 si U = ;?dS°l:S'SE0 s: J $ w s £ s ? {88S9SII8 *v Sli§li§ll , f I Share i t ; s 3 2 of 1015 ^ 5"S"Ss5S: S s Cate DOI CFA | ^odoQodoo 5 8 Jotibdo'Soo S tf&oiaafltfli®* o § fsi Z? * 5 ITIIIH 5 !§ssl§ss§ s sgslisiii i r§~ai§H 1 i 3 « i ollT e 3 I MO Rovlsed MO 1013 Saws MI DEA litet Satos % of 2013 Salsa Total PC1 2013 Inventory 2014 Proisetod Es potta 2014 Projected Sales 2414 Projected Om ntory ArE Avail Cate Uhroot MO *8 Company DEA Nom 1315 Requested 2014 nwWgmT^Q 60% ISSSSSSi 5SSS5SS8 -rtfl«oc?lo §3 " §§SSS§i§ $ a -Q •Q m" § o 1 0.000 0101 4000 1.003 3.826 0.000 0.000 S a " 5000 9.000 0.000 998926.931 I 0.045 runs 5.000 I a £' o § ^ (b)(4);(b)(7)(E) s 8' X » 1 153069.000 200,000.000 151.000000 36,860.000 698.926.933 0.037 37.266.703 53,892.000 0.602 200.000,000 50.000000 | 79.441.378 153069000 111 111 ")' i a .- o § § 1.010 0.500 1.711 3 2.258 2.000 0.438 0.000 0.542 0000 s 2.000 908.926.931 S .1.932 2 2000 * =S|S' r- § a 5 1 n 3 -SS- I = 1009000 10040.500 0000 13.330.000 1 g 0009 9,157.365 103.000 3 : 13330.000 .151.000 9.082.000 899926.931 1 14,060.493 03.330000 11 1 § g |S 1 M si S § g 5113005.000 1 230,5413.000 0,000 600000.000 736.303.000 5 247,075.415 | ; 600,030.000 461.271.000 24$,042.000 998,926.931 0.245 1 332.341010 5111.886030 r. III 1 111 m i a 1 a s 1 1 831.614.500 903,111.000 375.260.000 8 940,000.000 645,030.003 258.606.000 2 a" 1 910,000.000 998,92E131 0.646 1350.390081 9 169.170.003 996.084.601 940009,000 § * ™ m 1 o S 1 » 13,000.000 25,107750 0024.203 " I 4.497.010 17.597.000 33,000.000 3 * 33.000.000 16.000000 4.4601300 990920131 0.004 0.000 2 25,197.750 " » » § § O i = 13,500.000 6.600000 0.000 900120501 0.000 0 000 WIN 0 000 8.500.000 7.214900 4,950.000 3 3 00000 4.950.000 . * ™ a 1 § s S i i s I S Mg Totals: 1.799,837.000 1.459,029.000 1.656.0113.750 2 III 3 lis IUI Iiil 1 2014 Foists 181601 APO: 0687000.003 a S 2014 Floe Rsi Ased APO: 0.000 If o u. 5 II 5 s FDA Eat:12014 %RN APO • 1. FDA Esti: 1,712,305.000 Ui " 3 s | £ 1765 Est. (20141nd:111 APO' 1• • NS Est: 1,65E247603 e fc 111 2 5 i i e » I - s % I APO NJ? ustroo M made bated Ors wen toloofrom AtiPP sod FDA entrhara II 1! 3 ? § a S 2913 Eslabltsh APO:.. 1.720.903000 a £ a 2 u ? * 2 S 2913 Establish APO *MI 23% buffer: 2.150000.000 > i z if FENTANYL CD o CO CL 0) 05 Vol. I PageTO 806 Vol. I Vol. (D O) CL CO o 008h- abed (D'Th's tiCU)3N013000tICIAN § I § s ! 3! T.)9.0sthiy 5 paint,'" tuoc:tu, b. w 7,,, ? 5- I } 1 'I | s § 5 0013. b /l00) 1 , 3 Col 0Z100P4C fi Sh91.- L.171•110 i 1 H § 5 9 L !? 1. 0010096YCLI 4393 .61fl • . 0.101.70.0ggoZ) VO3 c 01 6 1 0066 xdYP.a 11. 211.6 211462 USs Kits s' I" iiii i ( 1 030 00000Caz 42,40m 170.41.1.13 Pt 62 i 330115.99t9S occr9Z1.900.0 :01.103 1 0001 a J r § port0sV9i.3'94) ! 8 ? s 0000 Viciagr6iE ZOO 0 Sig'631'990 6, 000 Z6legC1 0002[6'1106 000 00'009 11 » 1 r; corszeorre 000r09.909.9 8 m S 3 3,4 Ezt..trt 009,0Zroti'9 Coo 009"gon 003'4100'05 CO *! (i a 3. 9 1 " 2 3 S « a 95C0,91 990 sg, oar Z gg'S09 03031 Z f Ore 000000'000'ot 97..crEt0. 000 9100 1 t 9c.to gzo 000'0 000.60Z'Z tzsrtgo'94rg 5 8. gto'90r, gf.r C 00000060/9 000'000'961'0 n S 2" asr , e6 q * 1 1 " I i 2 5 " ; ZgrZ(3.9$4.90 Sit'561 6-90'gt 0130Lt'610.9t 003 199193'4 000000ZACN a C043 9 love I; «i oacr000'tocrc SOt'S9C'619.66 0000 -09.009.0 5 i 3 SLt LOS 096'61 0000001,95'9 000'000'00060 « 2 u 3 2 § 8 2 J 2- 3 s g W0 S. '0 tts' 0 10 SSC 691450'Cr cogrizegrg OW 003'191'1 - 000 GOO 000 1tEr 00D0 i «i 000'019111'1 ggrZ0r9g, k't om'cielso't g. I. 8 000 0 k.IP net 001,0001111'1 030 003.00 *» « 8 " I. » 2 § 5 tnrtfrt.'6CL'91 SSS:691 990'Sr CO3 3L9.0101:0 000 OS l',106t sf 000 0000006Z 00000001 MO lag 101'0 1 I- OTZZOS.19VOL 000 g4S-605't0 ItL'iltqC l'111't $ j 2 9 aCULOS'ISZ'OL 000500'001'9 001 r 2 S=.35S s V» 5 M. R 5 R e 2 OCa 0 Ai 11009'1- 0010 000f og1;0439 tst1:911. LLD 0 990'09L 990'0r 0006500000 003 00000Z i - COo j ? 1 S. 0017000019 67,2 n osrttym:1 ocancIE,51 coo cao 019 003.9 a 2 •* = 3 3. 8 'S 5. *51155 s 3 s - 166'01 039 COS'S woo ssc 691 050'sr 000 000009'0 2 d 000009'S OCVOtgrOZ 0030 060'0 00'100.00 3 0000 110'6 1, 3 0000 3 000061'[ r* 3 8 2 I m0002:50! 000010'00 000000'64C a60 003126001 11,9'061'00 1000 sscok's.90'01, 1 "~2§52 ,60'01,C 06056''110' c>' 8 000'0 n 00000096E s 5. !S5S:S!? 000 S - OSCL09'Of I 00C - 35 3"2J5|?3 1 " § S"8«.?SrS MOCK g 5,061 000 0 909'691:390's. 019'0 00000 00000 09712- 000'0 064,0 " ? 3 otsw 160'69 COOS »*. * - I 2 0070 POr'66 000 00e. 000 000000'000 000'0 COO 0 000 0 SSC'59 Vows. Docro COO s CG0 ott'SZt oocroS " s r'fiZt 000055'1.4 00G00004 *1 3 Q g | * ! rgaihu? § g s- £ © 0000 1900 0000 3000 10(6919905* 0000 COO 9 0005 m 0000 000'1 • ? I •* 601'0 SOLO 000g ddn8S2tS«3! (9)(L)(q)(v)(q) ° Qodooopooo ' §iii§g§§gig '8*|"S8ll85 " is(sii?h«s IS?§§§||||2 1 5 AutOoro i J s od,t...1.10 0100 Z ,,,....01 y,Loo Oton j, 0 LW i0...., t$ a.i.,,1 (Ice PT, .,• -$01,1v3ij gtoZ 1,L-1.5 el& 019 0-, 63)09iar on l rN 030 - S"?8?!8SSS;a !iv 0,11, 40 tsssssssaass j j a Ow 800' 6 4.JtI1.10.: A3010o.oi 6100 i§ii§i§igiii r» "I'l'lll I 5§iS§i§§§§§i orwsP-41, -., !0.1.1 1.100 .41. 463 61.1,1 5 ! •5 1.E 2610,11.^V Aptoo....100100.1.1.111az S ^AooaQeoodOo l88lS8S825s8 tssiHlissu "tfioiAiAinnviininvi - 5 giJ3;2 •8 B J s S iil81oll§lI§ f I 2 a ! a 1 | 5 5sgS2l*2S*3S s i'SJSSJSSSS! rrsihsiH 1*0 - 4.7 OM j .-th•te w * St( 91VICI'SCIa 00 1.103 § LZO-- 1.3 Y00 5 k ap„, H 33 tgs,130igsg.. i S .g091.L.4W1 CdO1.,4, ch 0100 J! I ! 5 S r r L r "S BasleBxale CWflt:01,16a, 1 2015201516thInitial el APQAPO Wort*Work Total00141 PQ Raq:Reqix 11) " S.S07.S2M290,507,526.429 FDA Fat:Eat; -067067 IM9EA1'PAS Ear . 051-051 Slumsnare of 201s2015 2014 ProtectproiecdedwJ CalclHIngCa1c Using CFR Projected Saiee Inventory AdJ Avail Caic so% Invent Comnanv OFA WarnNorn 2015015 R«Qjcst*?dReounattri VQMO 2014 ReviledRevised MOMQ 2013 5a1eaSale* 20132012 DCDEAA MOMQ SalesSale* .4%©f2013S*m of 2013 Salsa Total70141 POPQ 2d20133 tnverdoryinventory 2012014J prereeradProjected Eaport*Esporet 201*2014 Prolectea Sates Inventory AdJ AvaIl Cale 5.0.4,1noent UQMO (b)(4);b)(4);(b)(7)(E) (b)(7)(E) 5.000 5.0005000 00000,000 3,574,775,0793.S74.775 079 COOO0_003 COCOC.000 00000.000 0.0003000 4.9904.CC0 1.0001000 , 3.7501750 0250 5.000 64,06000064.CW.000 76.700.00076,700.000 00.000000 1574,775.0793 574.775.079 C.COO0_030 0.000 0.o.ooo000 0.0003000 63.03100063.003 300 26.000.09020 000 OCC 57.52557.525.003000 4320.000-7.525000 57325_00057.525000 30_00030.000 3030CCO 090 2921 3374.775.0793 574 775 079 cooo0_030 4.5004.50C 49.44745.447 0000 14.00014.000 6154963 MB 59,58559 505 -52322•52.322 30_99030.000 0000 1160001 16.COC 0:0000 78.0007E1,300.060OCX) oocc0.000 3,574,775.0793,574,775 079 0000oocc coco0,090 80000.000 00000 000 112.470.000112.47O.0C0 0 000 59.500_00050 500 000 52,970.03051.970000 78,090.0007fl.300.000 165.700.000I65.70C.000 =9.064.000229.064 000 128402128.462 930433 3.574.7750793.574,775 079 90360C36 197,918.181197,918.101 35,92035.9JO 696 0.0000 000 165,700.000165,700 0» 0.0000000 196.730_522108730522 205,379.031205,379.OS I 185.700_000165.700.000 iio.ooacoc 625.170.003625178.000 553,208000558,299 OCC 679,936.334679.036 334 3.574.7753374,775.079070 9.590C. 190 1,047.5563531.347.556.353 209210.335209^10.035 5,900_0005.900 000 568.344.000568.344 COC 330.000 000 574.137.028 1257,247,9061.257,247.906 574,127026574.137.C26 S34.CCC.OOO514000.000 4*5.000445,00300000C 134,7163M.71SOOO 900 3,574,775.0593.574.775 079 0.0940094 51515,683.2725.653.272 251,602000251,602.000 0.0000000 534.000.000 251.602251,632.000000 522.451400522.451.500 5593.252.00093252.090 622.451.920622.8Sl.S00 1,150,990.0001 .iso.ccc.ooo 1.179.0101.179.010000 000 997.252.900997252.000 3,574.7750793.574.775.079 0279 1,536430.0201.536.430.020 392,859003352,059.000 1,750i.raoooo 000 937.02O.MO937.820.000 S35.539.0OO515339.030 1.175.500501,175.501.750 1.532.421.02515*2.421.02S 1,170,601.7501.470.801.750 €77.000000 1,690.1 11663 2.58S.DCO.0O02.553,000 .000 1.417*^181.fi74,1115 000OM }389605.400t.309.605 400 3,5747753>74.77S079 075 ojag0359 2.141.2222141.222.819819 055,997.5506S5.W7.550 oooo0_000 22,425,000.00a.425,01X1.00 0 677,000.000 ,l..6.96.111.863.698.111.463 2.«89.<17.4742.889.417.474 1,698.111663 I14.BO8.057 114,008.057 3300.000.000>3.000.000 97.7197.7111 030000 44.542.00044,542.000 .3.574,775.079• 3.574.773.079 0.012 68.62424568.624.245 31.18031,109_003000 0000 123.500.000133.5CO.300 84.000.33Q64000.020 96.675.00096870,000 111,608.057 114,ens 057 4.5SOJ69.995 MQMO TfltaU:Totals: 5.569.9935,569.993.0ODOCC *337.4364.337.430.000000 4,590.209.595 2014 FliUlFinal ro4.141 APQ;APO: 5.400,5400,000,000OCC 000 2014 Final RevtvedRevisor! APQ:APQ, COOO0.000 FDA Eat (2814(2014 InitialInkral APQAPO •. 1 • FOAFDA Est):Esti: SJfil.flOO5.761,800000000 IMSISIS EM:Eat 12014|2Q1* InitialMnlol APQAPO'' 1I. 11,13IM3 tllj;8115: 5.124.600.0CQ6,124.600.000 APQAPO adjustmentadlosunar• baudbased on Increased enoapo.r1pen requirement*requirement& fo»|(b)(47for (b)(4) 23123156 EaubfahEatattish APQAPO'- S.600.000.0005.600,000.000 ...Jfitf&Ubllib2104fratattan APQAPO wtthwttfc 25%2511 averfcufftr 7.000.0000007000,7.000,030000 Zotf- <**- HYDROMORPHONEHYDR0M0RPH0N6 Vol. I PagePage 808 * APPLICATIONAPPLICATION FORFOR INDIVIDUALINDIVIDUAL MANUFACTURINGHANUFACTVRIRG QUOTAQUOTA 31 -JUL- 14 RoquostRequest ID-|l20281ID. 120291 bataTate SubmittedSubmitted 31-JUL-14 dame of_Banic C1an or List 1 ChamlealCheisiOe.LIOLLLYL2orDEllml-B91(only 1 par DEA-1B9) Schedule /Ll at Nuaber. 2. HYDRomORPHONEDROMORPHONE schedule/T.4ot Nuzber 2 ftiruq Code 3120-0- - Name andand AddraesAddreee ofof RoglptrnntReclietraint, ...... Pry: Code 9150-0 £ luota Year 2015 (b)(4)(b)(4) quota Year 2015 OEAOSA RagiRegistrationaeration NumberNumber(b)(4);(b)(7)(E) (b)(4);(b)(7)(E) pp b)(6)b)(6) Rat-Fax. NoNo (b)(6)(b)(6) ftnal\ail, AddressAddrpos5 hValDIVRI \ PbgtiO_Ha2114110134, HOT*NomJ AllAll QuantltlooQuaatitine areare toto bobe E*praaa«dExpressed Inin Qtiaidrama atof AnbydrouaAnhydrous Acid,Acid, Baae.Base, otor klfcaloldfoptalteleid(nRS < inventorynventory asas ofof DecDec 3131 677,000.0 855.855.997.55997. SS O.CO. 677.677.000.0000. ( 677,000.0 a.a.HulkBulk ControlledControlled Sutoatance/ListSubstance/List 1I Chemical...Chemical a 0.C0.0 O.CO. O.C0.0, o.c0,0 b.b.In-ProcessKn-Prcceos MaterialMaterial o.c 0 .( o^c O.CO. D.0 0.0 677,000.0 c.c. ContainedContained inin FINISHEDPINISHED DosageDosage FormaForm 855.855 997.55997 55 0. Itf Chethe PurposePurpose isis toto ManufactureManufacture AnochorAnother SubotancelsJSubotanceiel.. FurnishFurnish thethe FollowingFollowing Information:information: "Bid for this Purponc \ Yield KtiaNana ofof Nowxaw 9ubetancesubstance DrugDrug amount Used !or this Pox cue % Yield 20132012 I1 20132012 ? 201S2015 Batch Purpose Bet. Quantity [Est. Ccaplutica Time ProductProduct DevelopmentDevelopment borageDosage FormForm Strengthstrength Uaita/BatohUnite/Mash •t ofof BatchesBatches Batch Purpose Eat. Duatitity Est. Completion Time r*«oaforansfor RegisRegietrantcrant |l £xpExplanationlone tion ofof TransferTransfer DataDate of Destruction^Destruction Applanationixplaaat.oa • Total Quantity Packagingackaming Product KaneNana TtVangthStrangsh j~iini.tr/FXg~~y~Unitm/Pkg 1I ooft gkgcPkgs PUrpoeoPurpose I Total Ou tttttt • Remarksmarks Productionroduction lossloas estimated at 3,000 grans 1,000 gcamsgrams to support reference standard business Replaces application reference#references 11963419624 ' • • Vol. I Page 809809 HydromorphoneHydro ma rphone am41St ReCireMert5Requ rementj Initial 1014J9}4 A^diiwuiAddIt:onal 2014 2015 Qbo» Apr*l5 Aug-10 Delta 2014 Qca>1aQ.Kbia Grant Grant 2015 Quota Apv.15 Ali^lS Delta 5.15,13919 77,009.000 1,861 CPS AQAAOA SJ395,139 5.8505,850 CPS AQAAOA 5,150 6.2306230 1.080 OnpsIoneOiipavine (TOR) _ 3.2843,244 5.2525050 OripavincfTOR)Oripavirc (TORT 5,150 1.080 2.SB42,5134 S25525 HydecriorphoneHydror,orphene (ITMH) Iultuill 2014 Addition*!A ddetional 2014 2014 Inventorylove niory Calculations HMHILMH Grant Grant 201520i 5 InVenlarylny»pi»ry Calculation!Clittafil0111 ,- 521 20120133 Ending Inventoryloventerry 874074 874 20120144 EndingFs+,1oo, Inventory 321 Non i&lenblesaleable nuierie!materiel Ifi18 18i R NonsalNon saleablecable materielmittens] 0 2011 Available EndCfed. Inv.lav. 156456 156506 2014 Available Ea&Fad. Inv. 521921 • QL,,,,,, 1.675 2,110 2015 API QuouQuola 2,5542,5E4 1- 2^42014 APIApt Quota 1,675 2,110 202014M Disp,:itior.vDisposition^ 20152915 DispoDisposition*: uonv 242S2429 SaidSales 2,2512,258 2,257,92.257.9 SalesSalts Processing Losses (187)0871 (1872)n V2), ProcessinxProcessing Losses Q1(3) 2014 EodosgEnding Inventory 86 510.9520.9 20152010 EndingRodicy Ipvtcforyinventory 677477 / ConvertCenverteded ttoa % YearYearendend 4.7% 28.6V#21.6% ConvertedCoerseried toto 54Y. VeareodYearend 24.9%21.9% bga,ligs, basebate lip,tobiM }Mr, 2014 Estimated Dispositions Z2582251 20152013 DisootitiDilsloutionsona 1,3911.391 20(4 Estimated Dispositions 2425 20N2014 Estimated DispositionsDisposition* 2,158 2015201 5 Estimated Dispositions 2425 Average 2341 Average 1.8241,824 Average 2341 50%50%. Inventory AllowanceAltmann 912 54%SO% Inventory Allowance 1.171 ACTUAL YEAR TO DATE <5/31/1(0(31/14)4 REMAINING QUOTAOIJOTA ADADDITIONALD ITI ONA L QUOTA 2015 Quota CalcCale Net outputoutpui 1cmloss by Inputinpui toto OutputOimput InnsLoss by InpoiInp«i toto Output ovof H»Lose by NrtenfputNye oorpot LassLoss by of ittpatop Stepstep DesenptionDescription Input toto Step faicaikroecsa Yield of stepasap «fepseep Step olof StepStet., step •_ Step Step step Description Input to10 St_cg_Step Protr-15Frocrtl V.tldYield CPS-AOA RequiremeurtReguircmegft CPS-AOACI'S-AOA ReqvirrRaqytrcucpli r.sr.is CPS-AOCPS-AOAA toto Technical On papavanevine CFS-AOACPS-AOA toto Technical OripavineOripnvine (TOR)(ToR) 1,9711,977 90.12%9(12.1 1,782 1,6661.666 1,502L.S02 2.IS22,582 1,966 (TOR) 6.6,182182 9090.112%2_% 3.S715 571 OrOripavinelp*viae O0 rip*riparinevine • CPS-AOA toto Technical OriptvineOtipzvine CFS-AOACPS-AOA toto Technical OripavioeOriptvire (TOR) 1,7821.782 90,12% 1,6061.606 1,502 1,3531.363 2,182 1,966 ITOR)(TOR) 5.6715.571 90.12% 5,020 4,383 (63(631)S) TORTORioDihydfocripavine to DIhydroaripavine (DHO)(OHO) t 1,606 87,30%87.10% 1,4071,402 <2Qj](20/1 1£L1,353 1,181 []721 1,966 1,7171.717 (250(2009> TOR'toDHQTOR to DHO 5,0205,070 87.30%87,30% 4,383 4,3834.181 82.50%62.50% 3,616 (767;(767) DHO toto Purified Dihyd(Q«ip«vincDihyd/Ooeipavine fpDHO)(pDITO) 11111,412 82,50%82.5014 1,165 <3171{2171 1,181 975 (21((2tl7>1 1 i!!l1,717 1,416 (J0I300011 IMOPHOtopDHO to pDHO 'DHO1.)110 toto PunfiedPurified D'hydrooripavinrDibydrooripavine (pDHO)(pD110) DHO to PurifiedPunficd DihydtoonpavineDihydroonpavine 303 82.50% 250 forfor AcAesir-3si ci 0 82.50%82.50!. 0 0 0 0 a9 o0 o0 s(pDHO) forlfhVd.),(b)(4) .. 303 Total Total-row 11hsu1, (3- 15591(5>0I ' Total 13,:'35)* 1^5) HydrocnorphoaeHyde ornorphoat ForPer Sale llydromarphonfHydeoroorphont For SdrS-vk -I . 3313 78.00% 2,544 pDHO iQto HydramorphoneTHMH)Hydron hone (HMI() 1,030 78 00% SG3703 1,117 171871 558SCR 435-135 ,pD110pDHOloHMH to 11M11 3.313 78_00% 2,5842.584 99,87%99_87% 2.S812,581 (3) KMHFLMI1 Sized 11& Packaged 1,294 99.87% 1,2921,792 fij1.1 871 8701170 ell011 435 435 111I 1 1 HMHFOAM Sized & Packaged 1*1 0 7979.04•!.04% ' 0 Reprocessin,,Reprocessing DOSOO S HMHbLMH B77077 79.04% 693 1104)N 84) RegrocesungRtpTowair.g 00005S 15M31HM3T Total TTT(3, Total-row (IN')Cl^>» \it515 777sit Total Imo'irasnsn 2514 irssitissnsRAeTilitianal 2114 29142014 Inventorylavenlory CalculationsCalculation, TOR Grant Grant 20IS2015 Inventory CalculationsCalcalal ions TOR 20132713 Ending Inventory 161 161 7014 Er.dingEnding Inventory 1,1161,316 Non saleable mr.crialmaterial 10 10 N'nnNon saleable rnatenalmaterial 0 10112013 Available End. IpV.(no. IS1551 151 10142014 Available End,End- Inv.lev. 1.)16U16 2014 API Quota 3,284 5.25Q5,250 2015 API Quota 6.230 2014 Diapositions:Diipositioat: 1015 DisposlooniDisposiPcnr- 3,616 Conversion to HydromcBjjNooeHydrom 15 f P45oPag* 1l ;b)(4)(b)(4) Confidentialanfi dential 7/30/2014 Vol. I PagePage 810 HydfpmofphcneHydromorphoneam am Requirement* Rectulrentent5 ¥ i/fji bate i*i>kgs,b"t base kgs, bate 20l4E*cia\ated Diipoiitiont 2,705 20UDi62011 Dispositions. 20201414 CFi^Orlpavine LPS-UttpormeInventory Inventory Ta'rSalTolstoiTOT1 2014 A&HlIofulTKTAdditional 2014J Calculations GrulGreat CfMllCALM 20IS2015CPS-Oripavine CPS.OripavintInventory ?memoryCalculations Colculatiwu 1,161 20120133 EflriinahidingInventory Inventory 786786 786716 302014H Endinj*EndingL-ivctmyy DiventOrY 1.161 0 NonNonsaleable saleablematerial mstrrial 22 72 WonNonsaleable saleablematerial material 0 30 1 4 Avail able End, lrrv. 1,161 1012013J Available AvailableErA Led.Inv. Inv. 714714 16*164 3014 Avail a ble End. Inv. 1,161 3015 API Quota 7,WO 20201414 API APIQuota Quota 3,1395.139 5,8505,850 2015 API Quota 7,000 20142014Disposition*: Dispositions• 202015IS Diap<»;tioa»: Dispositions: Convert^Convertedtr> toOripavine 0ripavine 3,4665,466 , 5,4663,466 Com/&ncdConvenedio toOripavinc Oripavine 6,1626,102 1,9*7 20142014Eodiag EndingInvito Inventoryry 457457 1,1681,168 30153015Ending Endinglovealorr Inventor, 1,917 Coavcned to % Vtircnd 34,1% Om*er1dConversedto to% 55 Y k*t,ba« fcgs.kg,.faw bate Las, base 5,466 20112013Disposition* Dispositions 2.0042.004 30142014 EstimatedEstimatedDitposiliorn Di sposili on t 5,465 6,162 20|42014 EsEstimatedlimited Disposition! Dispositions 5,4665,466 20152015Estimated EstimatedDtipasiiiont Dispositions 6,1112 Average 5,834 AvengeAverage 3,7153,735 Avesaftc 5,824 30'/. Inventory Allowance 1.747 SO'/i30% InventoryInventoryAllowance Allowance 1,1201,120 30% Inventory Allowance 1.747 1015 Hydromorpbotic for Sale Forecast 10142014 HydromorptiopgRydromorphooefor for SaleS111CFprecut Forecast I 2015 Hydrocnoi one for Sale Forecasti 2G15 Total, kg 2015 102015IS Total,Total,kg kg MlSToeal.2015 Taal. 2015 Tom!, kg 2015 Customer UFA M Salt Total, kgfl CustemcrCustomer PEADEA U6 a SaltSill M Customer' 13T. a Salt ,Total, kgB k12 50 50 (b)(4);(b)(7)(E) 45 (b)(4);(b)(7)(E)(b)(4);(b)(7)(E) 50 *545 (b)(4);(b)(7)(E) SO 45 100 89 3131 3828 100 89 312 130130 116116 350350 312 355 316 111l 1010 355 316 540 481 542542 482482 540 481 667 594 1616 14L4 667 594 104 93 to10 9 104 93 13 99 8 15 13 2 2 184 t64164 2 2 SO 4S 376378 336316 SO 45 8 7 411411 366366 8 7 10 27 138118 123111 30 27 IOC 200200 178 100 ii89 200 178 4242 3717 200 171 136 121 22 22 136 121 17 \S_ 3535 3111 ., 17 15 2,714 2,425 150 J13434 I Tali!Total 2,724 2,415 28 25 47 42 lfllS2015 OriptvtoeOripavioe forfor Sale ForecastPolecat t 20 15 Total, »*£ 2015 1015 Total log 2015 DCA« Salt Total, UfiB 6 5c . Customer DEA4 Salt Total, kgB EXPORT 350 M26 2323 :t>)(4>b)(4) EXPORT 350 Pa* Vol. I PagePage 811 / 1.11) BuieBaalc Ctikt;creel: 20120155 InitialInitial APQAPO Works!W071131 'el' ) Total PitPQ Requ.Rcquv 4.347.0004,347,003 FDA Est:Eat: ~) 11.15JMSEst EnC .117 ShiesShart etOf 2015 CaleCilc UsingUsififl CFMCFR Corm:AntCompany DEAPEA NumMum 2015 RequestedFetjucsled MOMQ 2014 Revised Ligfcq »120133 SalesSeles 2013 DEAOEA MOHQ SalesSafes % of 30132013 SatesSeles Total P01PQ 23132013 invent:4yInventory 20142074 ProjectedPr«jarted ExportsE*porti 2Q142014 Projected SaltaSates 2014 FreieetedProdded InventoryInventory liojAdj AvailAVIii Galecafe SQV,50% Inventlitvwnt MOWQ (b)(4);(b)(7)(E)(b)(4);(b)(7)(E) 2.0002000 2.0002000 0.000 1,407.0001,907.000 Q.OCG0.000 0.000 0.000 00000.000 0.5000.300 1.500 1.1001.500 •1000-1-030 2.000 5,600.000 3,6000403.600.000 1,007.0301 .907.000 1007.0001,307.000 1.0001.00C 4,347.000 42.000 6.000 4.934C004,494.000 1,038.0031.630.000 2.731.5002,731.500 7,601.7507.631.750 5.600.0005,600.000 MOMQ Totals: S.5002.000602.000 3,602.000 5,602.0005,502.000 2014 Final initialInitial APO:API:: 1,600.0001,600 000 I0142014 Final RevitedRevised APQ:APO: 00000.000 FDAFCA FahEll; (2014 InitialinHifll APQAPO * 1 • FDA Eat):Eml): 1.600.0301.600.000 IMS Est: (2014(20« lnlitalinitial APQ-1APCI. 1 • 1MSIMS Est):Gal): 1,7661,708.400 400 26132015 Proposed InitialInilulAPQ: APO; 2.700.0002.700.003 2015 EstablishedErtaWisfxd APQ:APO: 5.700.0005,700.000 2015 Established APQAFO wWiwith 25*25% hater:buffer: 7,1257.12S 000 .1' \ LEVORPHANOLLEVORPKANOL Vol. I PagePage 812 RailsfadeClAti Cis":: 20162016Initial 101031APQ APOWork Work FOA EM: Tela!7014190PQffeqtM. Req.. 1.3J2.T73.00C1.322,773,000 r."1411) FOAESt: IMSIM'SEst: Est:. 3014Pro)e 65,438.207.625 MQMO Totan:Totals; 73.302.00573,302 005000 000 Sfl.BI50,612.11752.875 OCfl oca 65,436.207 E25 201*2014Final Elna1107041AP9InfllilAFQ:. 73.000,000.00073,000,300000 20142014Final Flr.liFterrisedRevised APQ; APO, 0.0000.000 FDAE*t:l2014lilHk1Fps Est 1201A ['VW APQ'iAPQ • 1 • FOAE*t):FDA Est): 73.COO.OOO.T0,000,000000 COO IMSOn £tf.Est 12014(2014 IniUalinitialAPQ APO'• 1 1 • IMSIVIS E*1):Es0: 73,000.000.00023.009000,000 APQAPOs surtIcumctonl, ion!,no nOadjustment adjust:1+millre^uinti required ;) MORPHINE (FOR CONVERSION) Vol. I PagePage 813 s APPLICATIONAPPLICATION FORFOR INDIVIDUALINDIVIDUAL KANOPACTURINOMANUFACTURING QUOTAQUOTA 31-JUL- 14 RequestRequest IP.|l2.Q271ID. 20271 bateate Submitted)Submitted 11-3M-14 game of Basic Class1-tUL-Itler. or Lilly 11 chflmlr.alChemical (oplv(only 11 parper PBA-ia.ll.DEA-11121_ 40EPRIUE 4FOR CONVERSION) iehedula.'T.latC, dule/Liet NumberNumber S.0 Jrug Coda 93CP-A MamaName aniand_AddroseArid roan ofof RegistrantAssaatr.ant run Code 9100-A luota Year 201S (b)(4)(b)(4) uota Year 2015 >BAEA RegistrationRegistration Numbe:Number(b)(4)(b)(7)(E)(b)(4):(b)(7)(E) :ontactrontact ParBonl(b)(6)Per by6) ax.ax. Hotto (b)(6) Wo gmail Addre b)(4):(b)(6)b)(4)(b)(6) I 'honghone No. , or AlUlcldlnot as salta) HGTBiMarrs A11111 QuantitiesQuantities «r«aro tDtobe he Kxproaaodnapreased Inin Gransarmee atof AnhydrousAnhydrous_keid,Acid ttsaeamae, or Alkaloid(not 9.1 3.tl. QuotasQuotas ProviooplvPrcyiouely IbuIssuedUfld byby PEADEA 2014 20 IS Quota Requested Ouoceota HistoryHistory 20133013 2014 2015 Quota Requested Qu • 26,251,000.0 12,796,12,796,000.0000.0 IS,15,500,0E0.0500, OCO.O 0.00.4 • 26,251,000.0 Year lot Preceding Veer EBClmaitfl for Kstinst* for Year ProductionProduction Data QcvlInd PrecedingPreceding Year lee Preceding Year retleate for ascieate for Year Data Rcqi:f 3-fld .. CurrentCurrent YearYear Requested as o f Dec 11 inventoryInventory as of Dec 31 6,712,000.0 6,712, QCO.O 2,451,207.2,451, 207.0 0.00.0 6,712,030.0 6,712,000.0 a.a.11ulkBulk controlledControlled Substance/ListSubstance/List 11 Chemical...Chemical o.t 0.O. 0.00.0 0.00.0 0.0 b.b.In-ProcessIn- process MaterialMaterial 0. 0..0 0.0 00,0 o.q Forms ...... 6,712. 000. c.c. ContainedContained InIn FINISHEDFINISHED DosageDosage Forms 2,451,207.2,451,202.0 a0.0 64,722,000.0712, too 0 4,712,000.0 Dispoaition(Sale)ftilizationllspoait ion (Sale) /Utilisation 22. 171,000, 22, 371, 000.0, S,5.787.0767.0 o.o0.0 22,371,000.01 22,371,000. a . DornoG t ic ... o.< a.Domeatic . 0.00.0 o.o0.0 0.0.0 0.t b Exports 22,371,000.0 b Exports 5.787.05,287.0 0.00.0 22,22,371,000.0371. OOP. 0[ 22,37L,000.0 IcquAcquisition/productionis i tionj Product ion C 0.0O.b 0.0.0 26,26,251,000.02S1, 000.0 26,26,251,000.0251, 000. a.a.DomeaticDomestic sources..Sources. 26, 251, 000 .0 0.00.0 00.4 26,26,251,000.02S1, 000. 0 26,251,000.0 ifIf thethe Purposepurpose iais toto ManufactureManufacture AnotherAnother SubstanceSubstance(0.(e| , FurnishFurnish thethe FollowingFollowing InfoiraaticniInformation: Amount Ujaj tor tblc Purpose \ Yield N«ce07AO ofof NewRev SubstanceSubstance DrugDrag Amount Deed foe thie pnepear, % Yield 2013 20122012 2013 1 2015 7, 400.960 14,500 93.45 :ot)BINECODEINE (FOR SALE)SALE) 90S0-B9050-8 10.276.S1110,7/6,811 7,400.960 14,500 91.45 Purpose Bee . Quantity iBatV CrapletIon Tia»e ProductProduct QevalcpneacDevelopment DossgeDosage FormTerm StrengthStrength Unite/BatchVaite/metch 1 #0 ofof BatchesBatches BatchPatch Purpose Sot. Quantity Est. Completion Time c rtaMitotTeamster Registrant"]Regiutrent i ExplanationEmplanstlou ooft TransferTransfer . CatsDate ofof CestructionDestruction![ ExplanationExplanation • Pur poa e j Tot el Quantity Packagingpackaging Product NaaeName Strength Pnite/PhgUnite/Pr0 |j I8 of Ffcflsraga Purpose Total Quantity RemarksDomarko 22.371,00022,371/000 grams for conversion to codeine for sale, of which 6,855,000o,oss.000 gramagrave for conversion to 1414-14K-HM 1,000 grams to support reference standard busineoobusiness Replaces Application ReferencedReferennell 119668119688 . 1 i • I > Vol. I PagePage 814814 Codeine From MiMc r... )quirementsqolremenis / rassrairjinitial 2314 Additional April August Submission revilioureVil Delta 2d70141 4 Quota Grant 2014Granf2014 Grant CommentCornmeal 10152015 QuoinQuota Submission OKI Comment Morphine forfor Conversion forfor Cod forrot SaleSsle 10,41110.431 14,50114;501 Morphine forfor ConConversionversion 22,000 19,39510,395 (2.6U5)(2.605) Morphine forfor Conversion forfor 14411414j|M 0 999 Morphine forfor ConversiooConversion forfor 1414-KM-EM 0 6,855 6,855 Tola!Total Morphine Icefor Conversion 10,431 15.50015,500 Total MosthineMorphine for Conversion 11,00022,000 26,23126450 4,250 Total Codeine forfor Sale Initial grant TctilTotal Codeine forfor Sale.Sale: (4.500) 25,500 kgBkg13 Codeine ForFot Sale (fiom(horn Morphine) 12,260 17,231.565 kgBkgE3 Codeine For Sate 19,000 14,500 <4. 50H> 20142Z11.1 hlorPhineMorphine for Conversion InventoryInventory Initialinnsran 2014 AdditiooaiAdditional Calculations Grant 20)42014 Grant 10152015 Morphine for Conversion Inventory Calculations 2013 Ending Inventory 2,454 2,454 2014 Ending Inventoryinvenlory 2,833 NonNoa saleablesalcabk material 3 3 KonNon saleable material 0 2013 Available End. Inv. . 2,4512,44t 1,4512,451 10142014 Available End. !sty.Inv, 2,8332,853 2014 API Quota 10,431 14,50114.301 '• 2015 APIAll QuoQuotala 26,126,250SO 2014 Dispositions: 10152015 DispositionsDisposition*: Converted toto Codeine 13,120 13,12013.120 Converted 1oto Codeine 1515,5161516 ConvertedConvened toto 1414-HM-HM 0 999 Convened toto 14-11M14-HM 6,SS56,555 Processing Losses - Processing LossesJuncoes - 2014 EndingErvdiag Inventors-Inventory •135-119 1,8332,833 1012015S Locliogfcndiug Inventory 6,7116,712 Converted toto % YorcildYearend •2,2%-3,2% 25.8%25.5% ConvertedConverged toto % YearYearendend 30-0%30.0% , lira,kgs, base Vgs,lcr,s, base 12013 Dispositions 7,fl727,572 2014 Est. DispositionsDispositions, 14,119 2014 Est. Dispositions 14,11914.119 20120155 Est.EST. DispositionsDispositions, 22.37222,372 Average 10,995 Average 18.245 50%50%. Inventory Allowance _ 5.4985,498 50%50%. Inventory Allowance 9,123 "WUTTWith 2014 Codeine Phosphate from Morphine CurrentCumot 20t52015 Codeine Phosphate from Morphine Inventory Inventory Calculations Quota Calculation!Calculations 2013 Ending Inventory 2.6442,644 2014 Ending InaientoDInventory, ' 2,7472.747 Non saleable material 26 Non saleable material 0 2013 Available End.End, Inv.inv. 2,618 10142014 Available End, Ion,lav. 3.7472,747 20201414 API Quota 12,260 2015 API Quota 14.500 ZtlH2014 Dispositions: 2015 Dispositions: Sales 11,3601 1,360 Sales 11,176 Processing Losses <2221(772), Processing Losses (1,0151(1,015) 10142014 Ending Inventoryinventory 2,747 10152015 EndingFading Inventory 5,056S£5£ 44.9% Converted toto %'A YeaYearendrend 24.8% Converted toCo %V. YenrendYearend 44.9?. kg*,]cgs, lutebase . - fcgs,kgs, batebase 20132011 Dispositions 10.761 2020141 4 Est,Est. Dispositions 11,360 2014 Est. Dispositions 11,36011,3643 2012015S Est, Dispositions 11,176 Average 11,06011.060 Average 11,268 50%5I5% Inventory Allowance 5.530 Sft%511% Inventory AllowanceALlowance 5,634 PagePagel 1 !b)(4)b)(4) Confidential 7/30/2014 Vol. I PagePage 815 CodeineCodeine FromFrom McMc/4°4184)quiretnentsqulrecnents / C5TIMaT£0NESTIMATE ON kEMAlNiN^'REMAINING ACTUALACTUALYEAR YEARTO TO DATEDATE(JUNE (JUNE30, JO,2014) 2014) QUOTAQ1110TA 20151015Quota QuotaCalc Care InputInput toto NetNet outputoutput i/»ilass byby Inputluput toto OutputOutput ofof LossLoss byby NetNet outputoutput oiof LessLoss byby MWC itep step DescriptionDescription StepStep ProtestProcess YkldYield MWCMWC ofofstep step stepstep StepStep StepSeep stepstep DescriptionDescription InputInput toto StepStep ProcessProcess YieldYield MWC 1 rep step 85.60% 26,250 Ci'S-AMACPS-AMA toto MorphineMorphine fafoer Convmom. 7,6577,617 8SW-85.60% 6,56,554S< 4,5294,529 3,8763,876 CPS-AMCPS-AMAA in MorphineMorphine foefor ConvCony 30.66*30.666 85.60%. 26,250 (CodemaCodeine forfor SateSale CodeineCodeine foefor SaleSale 15.516 89.00% 1.05 14,500 MMorphineOf£tunc forfor ConvConylo toCodeine Codeine foefor SaleSale 7,4787,478 890%89.0% 1.051.05 0,9886,988 5,6425,642 5,2725,272 Morphine forfor ConvCorivto to CodeineCodeine forfor SaleSale 15,516 8900% 1.05 14,500 13.572 i93ft CodcineffrCodeineat MotphlMorph]to toCodeine Codeine PhosphatePhosphate 5,2205,220 93.00%93.60% 4,8804,886 <334t43 14 I 5,7755,775 5,4005,406 1t370)37111 CodeineffrCodeine(fr Morph)Morish) totoCodeine Codeine PhosphatePhosphate 14.50014,500 90.00%91450% 13.572 19281 13,485 tS7t Codeine PhosphatePhosphate Finished 5,1145,114 99.36%99,36% 5,0815,031 (.331(331 5.4905,490 5,4555,455 (351(351 CodeineCodeine PhosphatePhosphate FinishedFinished • • 13,572 9936%9936% 13,485 1671 U-OISj TotalTotal <3tV?|(367) t-M5>0033 TotalTotal (1.015) 2015 Forecast 2015 2012015S Total, Tonal, kgkg TotalTotal. CustomerCustomer PEAKDEA 8 StiltSali JjgBliel3 CommentCommen1 (b)(4);(b)(7)(E)(b)(4),(b)(7)(E) 1,900 1,406 300300 222222 158 117 300300 222222 300300 222222 includesIncludes Generic !b)(4)b)(4) 12,10012 100 8,9548,954 4545 3333 Total 15,103 111.1761.176 COMBINED CODEINE INVENTORYINVENTORY (TASMAN AND MORPHINE CODEINE) With Current 10142014 Total Codeine InventoryInventory Calculation*Calctdatioen Quota 202015IS Total CudCodeinetine InventoryInventory CalcCalculationsulatkiru 20132 013 Ending InvtruaiyInventory 5,1665,I66 2014 EndEndingrng InventoryInventory 4.8S24,882 N'onNon saleable material 38 Non sakablesaleable material 0 2013 Available End. lev.Iev. 5.128 2014 Available End.End, InInc.v. 4,882 2014 API Quota 17,232 2015 ATIAPI Quota 25,500 2014 Dispositions: 2015 Dispositions:Dispositions- Sales 16,114 Sales 19.16819,168 Processing Losses (1.363)(1,362) ProcessingPionessine Losses (2.291)(2,291 20142 014 Ending Inventory 4,882 ZglS2015 EadjppEnding InventoryInventor/ 8,923 Converted toto % Yearend 33.4%33,4% Converted toto % YcarendYearend SO.50.6%6% 1‘83,to balebate kgs,kg", base 2013 Dispositions 13.14113,141 2014 Est. Dispositions 16,11416.114 2014 Est. Dispositions 16,114 20152011 EstEst. Dispositions 19,168 17.641 Average 14,628 Average . . 17.641 7.314 S0*/« Inventory Allowanee 3.821 SO%50% Inventory Allowance 7.314 _V 50% Inventory Allowance 8.821 Page 2 (b)(4)(b)(4) Confidential 7/30/2014 Page 2 Vol. I Page 816816 0*yrnor^>on«Chwrnonf.boe• fo I' •E&r4.2447 TO3444144.05TiT «>1.0/4 miall ni^gi *r»as 15 DriU llll1/14Qm<. (twin C^xCon cCrontiw CMnWu SCL•Q•••.• Are-15 Airk15 bell. 12.9CQ IPSC-AOAPSE•Ar.)t 5.2)20.2)2 T56 402 !<*<1661 [KSC.AUA1•SC.AUA 5.H93,239 12.000 7J6I7.141_ 42£. |Kjarhjr jp, C-aivcnkrt 22,000 42S0 NtophixicrCcwMeephon tor Conon. 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Story*MerpAireirx k*I.4 CcT>micMamenice • 1,1101590 044233364 kr CaDown n11pe ee.l~da b)(4 AA gaolII be auk:Mar 2.012. CX)DWf*crtc lc» tattfna« 6.745 Suhj irowCTS ii Itajy-fl fa old I»cnci. tsinR ilaf 41 1»PI fer ?0lS. Q»ymocp2>o«KthrfinantAtene fo*fa CftiinuoCOweenon 3.0217071 jjll1121 04)4eserptecne Ite Cenniiina 1.745 otd ow 4. I.O. for 201S. 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(b)(4),15)(4' 1) CamtUiAC.9,454051aw Cakint Calcine 11.12011.110 11.12011.110 0*V«rtfld4:441,4c35:195(OUodfiM cmtrre 13.51615.315 CiOimatamner b»ihatrd .a «olJtold toe*tth p»4ip...10v.iD fth Qf-kraJordcradfor 4. 2012015.S. C0T»lTT-dCon wriedit! 16 I114191«4(M TO Ctfwnni la i4 i^r SLwfJotuiff uglVaMBlOTftJO^OrWyt: btfOfrHfri W999 99? C."44,trzi ut 14:31.1 MM6.653 .1411.0F czi9crIxm .1.1.120 do 9e6tErmie b. 455.54=541 Piocaimp119a50;52 Ijom1.mars - . 1554.4,6,im£ Leta/ - 2114 Lading frogmen _4jyr-4,237 7,8)57,531 Mll£*4»£k>wilw71015 FA 5.014•44,1ary_IWr iiLLL5,71t taste Oaf tal5Yfiwnd Yearr4 1IJT.-al , . ttlS21194 CwVrKrJCe9,4144-,1» a %¥f«lt*414 Yco 44442 xiv. k£LUM4 9, 11544 to141;5 kmmMa 101)1011l>.txwilx»u 19 rporibou 7J217,171 20142014 E*.EA. DkspcwUoothsmaLott _ H.m14,119 20H1014 En.PiwuiuofuEa Dispotticar U.IH14,1 197 2015191$E9Eg plcfagpci^.t 3.591 27,17:12 372 A>q>fl*.1.scn56 IftW10,990 ArmiT5,54E9 - "i1(145tuT ln»«4ofy AC*Wf»c4~ 51 V» ImtBtny All*w*»ct .955:15.m.aity.k.Lmranes 2S5,496 .55Y.1039att-t, Alfmrtme 9,12)4,121. TOT 7 1gal 1414.1 B.U* Bunti r*»i T»i«l i twfp««, kjB iUlch B»Kh I TW»J TcnJ Mott, Paw% 1•444/ 7.4.1 ..-.1.. kl.B Bab+ B41.9t 7941 119441 WM., kat T-oJ Uq Tr-om LMtylli^ Output. r >0145914 QiOry...rpimo>rfi» > tfCminlaiC.4 C.45,444w PiForm., 20151015 Oiym>4iinWCamifwOr/warp/m.4148 Caverltamt f.Foram, Onl—tCo:dam:we I DtAWLISA/4 I kniMl1.54.61/ 8*6bat, C»tt« I CEAIDP1411 if t74z151 t«B (b)(4)!b)(4);(b)(7)(E) (b)(7)(E) 1A57Ltt37 UU (b)(4)(b)(4);(b)(7)(E) (b)(7)(E) 6.00 5.1)11 (b)(4)(b)(4) .55191451,alunfid^ntial 2/JO/2QI43/14/2014 2 Vol. I PagePage 818 Basic Cb*kMass: 20152016 Initialinitial AAPOPO WoWorks!'rfclf PDAFDA Cat: T*rtj|Total PQPO RoftwR000 1,130,0050001 ,130,005.000 "'WI ) Col: IMSIMS EtfEst: ShoeShare at04 2&152015 20i4ProJpewd2914 Projected CalcCale UsingUalog CFRCPR 50V.SOY. 2013 inventory 2014 ProjerteO fi*porli 2014 Proje rt«d Sa*»9alos InventoryVora ntory AdjAd) Avail CatcCsic inventIn.ra «QMO Company DEANvmCEA Num 20lSR.«|ueatwa2015 Requested WQMO 2014 Revl*edRevised MQMG1 10132013 Sale*Sales 2013 DEA MQ Sale*Sales %otY• of 2013 SalesSale* Total PQ 2013 Imentary 2014 Projected Exports 2014 Projected 35.ooa.oQ3 ?i.DS4.aao 386.554 .000 0.C54 1.W0.7W01.503.768 14.352.000 D.0000000 3fl.000.00D30000.005 19,004300019,ooo.ooC 37,014.03037.014.000 74.511,48574,311,465 3737.014.000 014000 (b)(4);(b)(7)(E) 53,450.00053,455 030 35.000003 21,054000 356554 000 0054 (b)(4) (b)(7)(E) 203.91 4 OCO 45Z.390.2SQ 1.279.90S.765 450.000.000450000.000 430.00Q.OOO430,003,000 365.GO0.D3a565000000 306.654.000300.654000 0.S460.646 1,066,474.2121,068.474.212 173,107.900173,187.000 O.OOO0000 440.000.000440000000 203.914 452390250 1.279.905765 450.OOC.COO460000000 40.000.00040000000 oooo0000 o.ooo0.000 386.6543663.654 000 0 000 0.000 o.ccc0.000 00000.000 40,00040000 000 0.0000000 . c.ooo0000 40.000.000 40.000.00040000.000 MO ToUli:Totals: S43.4V3DM543.450 230 465,000 000 527,014.000 ZOMRnatlnR^IAPQ;2014 Flnat 500.000500,000030DDQ 2014 PinalFinal Revised APQ:APO: 00000200 FDA EatEst (2014potAIrdtalInhlal APO •. 1 4 FDA EmJ:Est): 500.000.000500.000 063 1185IM5 Est: (20(IOU1 4 InitialInklsi APO *• 1I *+11.151HS E*H:Est1: 50C.8CO.IW0500.900000 2012515S PropowdProposed InitialIndia! 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Sing a 12 slogulilli OM OdV moui 410Z 00106 :ate* 3 5 s ? ii o W) s o C, r>, L r 1 V. * APPLICATIONAPPLICATION FORFOR INDIVIDUALINDIVIDUAL HAHUPACTCKISGNANUFACTURINO QUOTAQUOTA bato Submitted | 26 -MAR- 14 RoguestRequest IP.IU86S0ID.116650 Date Submitted 26 -MAR-14 NnmpName atof HaniBasisa CIClassAnn oror LloKLkst.,1_Qhamical1 Chemical (only(only'l'1 p«rper DEA-189)DRA-199) gchadule/Llae Number 3RIPAY1KEOnpAvINE 'clledule/Lidt Negabe_r . 2.2 c briiCT code 9330-0 L HamsHigimAnsUddreseand Add roc a ofof Rasjjtfxa"^Reairstrant rua Code 9330-0 Year 2015 (b)(4)(b)(4) " juotaotu Year 2015 >eaEA RegistrationRegistration Nunbor|(b)(4);(b)(7)(E)number (b)(4);(b)(7)(E) CoateatContact PflgflonFb1(61Pernoallb)(6) fra.nx. No (b)(6)(b)(6) Phone Hp Small,=ail IrlHrdAddressae IVI1V41(hVA)hV4WhVf^ ;Phone No. NQTSj00r01 Mlall QimntQuantitieaitiafl ar«are toto b«be grprrgrrdExpreseed Inin Qraaadrama ofof AnhydrousAnhydrous acidAcid, gMBfRama, oror ftlfcAloldtnoCAlAaloicl(aoa »»aff 8alt«)arnica). QupcagQuotas PreviousPreviouslyly TeamedIssued byby DC&DEA [ 2015 Quota Requested Juot*Own* HistoryHistory 20132013 20142014 2015 Quota Requested 1,131,000.0 1,467,0391,467,039.0.0 1,674,3161,674,110.0. 0 0.00.0 1,131,000.0 T«»r lot Preceding rear Satirute Jot Eatir-ace for Tfear Production DataData 2r.d2nd Ps«ctdirgPreceding Tear tat Preceding Year Setimate For Estirate For Year CurrentCurrent *«arYear FcqyeaCcfiRequested inventoryL40antOry asas ooft DecDec 3131 253.464.0253,404.0` 0.0 o.c0.0 OJ0.0 a.04.601hBulk ControlledControlled Substance/ListSubstance/List 1 Chemical...Chemical o.o o.c0.0 0.00.0 00.0.0 0.0 b.ln-Proceoob.In-Proceos MaterialMaterial 0.0 o.c o.c0.0 o.o0.0 0.e- 0.0 c . Contained in FINISHED Dosage Forms 0.0 0.0 c. Contained in FINISHED DOsage Forms 25^,464701253 464.0 0.00.0 0. 0.0 Disposition(Sale)/UtilizationJlsposft ion (Sale) /Utilization 1,131,000.0 154154.942.0, 043 JOT0.0 1.1,111,090.0131,000.0| 1,131,000.0 aa.Donestic.Domestic o.o o.c O.C 0.0.9 0.0 O.* 0.0 bb ExportsExports. . 1,131,000.0 154/943154,943.0 o.o"0.0 1,131.1,131.000000. 1,111 000 0 &cquiAcquisition/Productionsit ion /Production 1,131, 000.0 154.154,690.0690. t O.C0.0 1,131,1,131,00C.000 .0 1.131 000. a.a.DomeaticDomestic Sources..Sources 1, 131,000.0 154,690.154.690.0C O.C0.0 1.131,000,01,131,000. , 1,131,000. IfII th#the PurposePurpose iais CoCo ManufactureMenuFaCtUre AnotherAnother SubstanceSubmtance(S),(a) , FurnishFurnish thethe FollowingFollowing Information:Information: \ Held j-'aaaKano ofof tiougee SubetaACeSubatanCe DrugDrug AiLOUDtAmount UagdDead forfor thishis Purpose•oaa % Yield , 20122022 2013 I 20132015 0 116.000 45.00 HYDHOMORPHONEHYDROHORPHONE 91SO-09150-0 00 0 116,000 45.00 17,237 146.000^' 45. OC DXYK0RPHCWEOXYKORPHONE (FOR 3*LE)SALE) 9652-B 15.05335.053 ' 17,2]] 166.000 45.00 Batcbefl Batch Purpoae *tt. Quantity |Egr- COBplecionTlaa ProductProduct DgvalopaantDevelopment PoaagaDamage FormForm StrongStrengthth tfnitw/BfttebVnite/natch #B ofof Batches Batch Serpent' I Mat. Quantity rEet. COOplotioo Tian • . L Transfertransfer itegUtrantRogiatrant jI RxploaationRoplisoation ofod Tr*n»forrriostor !s OntoDate of Destruction J Explanationtaplanstion Purpoaa j~Totpl Quantity Packaging Product IfanoHaas Strength |I Unito/FkgUnite/Pkg |I *P of PkgePkgm Purpose 1 Total Quantity . ' RemarksRanarfce Quota is for supply of 500 Kg totol(111611(h)(7)(F)|(hW4WhW7VR kb)(4)Idill1(b)(4) h*111 algQalso use Oripavine forCor internal conversion to 9xynorphoneOxyworphone and HydromorpfconeHydromorphone.. Seesee supporting documentation submitted via er.allemail for sales breakdown.treakeoum. Lc Vol. I PagePage 821821 * APPLICATIONAPPLICATION FORFOR INDIVIDUALINDIVIDUAL MANUFACTURINGMANUFACTURING QUOTAQUOTA , equest;t I0.119726ID .1119726" 4atebo to Submitted'Submitted I 0101-KAY-lT-MAY-14 at 1 Chemical (only 1 oar DIA-161) L ^RTPAVIMSIFAVINE Schedule/LintSchedule /Lint NumberNamhor 22 Hftafl and AddroaB of Roolatrant _Egg3KUO CedeCodft_ 9330-03^Q-Q (b)(4)(b)(4) uotaiuota YearYear 20152015 EA3EA RegistrationRegistration Number{b)(4)PX7XE)Number ;b)(4);(b)(7)(E) ceatBSJ^Earao_t_Egte MS) NNo (b)(6)(b)(6) smallail AddressAddteaq 1h)(41(h)(6)bW4VmV6i .5mehone No,No NomfJOTRi AllAll QuantitiesQuantities areru toto bebm EwortuniedBypraoaqd inla GrandOr? ofof AnhydronaAnhydroua Acid.Acid. Base.Baac, oror Alkaloid(nosAlkaloid (not adaa Salta).Salca) •uotaaOuoeaa PreviouslPreviously IssuedRaved bby DEAPER • Quotaeta Hiatt:1:yHistory 20132013 20142014 20152015 QuotaQuota RequestedRequest «d 1,000,000.01,000,000-0 1.100.000.01,100,000.0 0.00.0 1,200,000.01.200,000.0 •Production reduction DataData Ind2nd PrecedingPreceding YearYear tattat PrecedingPreceding YearYeir EstimateEstimate forfor PatleateEstimate forfor YearYear CurrentCurrent loneYear RequestedRequested Inventorynventory asss ofof DecDec 313L 3.3,367.0167.0 0.•0.0 O.0.0 0.o.o• aohilka. Bui* Controlledcontrolled Substance/ListSubstance/List 11 ChemicalChemical... O.•o.c 0.00.0 O.0.0 0.o.q• b.Ia-Processb. 3n-Procc8P MaterialMaterial ...... 0.•o.c O.0.0 o.c• 0o.c C. Contained in FINISHED Dosage Forms C. Contained in FINISHED Doeage Forma 3,167.03, 167 . Q 0..0.0 0o.c O.0.( •isposicien{5alel/Utilization5ispcsicicn Itf thethe PurposePurpose la!• toto ManufactureManufacture AnotherAnother SubstanCele).Substance l») . FurnishFurnish thethe FOL1ovingFollowing Information;Information NameNajho ofof NewHow SubstanceSufcetancs DrugDrug Amounttoount UsedOaed forfor thinthis PurposeRurpoaa 1.4 YieldVisld 20122012 20132013 20152035 . . ProductProduct DevelopmentDevelopment nonageBoaage Form Strength Units/Batch IS of Batches BatchBatch Purpose Rot.Est. QuantityQuantity sot.|Cst . CenplationCataplstien Time Fonm I Strength | Unitn/Batch 1 i of Batches Puzpoee1 Tias Ir.nafarwaster RegiattaatSagl.ttmt | ImplanetionExplanation O1of TranateeTransfer • DatePate ofof DeeteuctionPea tract Loa IbcplanationExplanation PackagingPackaging PredwctProduct NanaWm# strengthstrength I Vnits/ftsonit./Pks j 0•of of Pkg6Pfcgs PurPOnePurpooe J IntelTotal QuantityQuantity BlearkaRenarkcj Oripavine3ripavine mfgmfg quotaquota isis requestedrequested toto convertconvert oripavineoripavine toto aa BuprenorphineBuprenorphlne lntereediateIntermediate forfor f[b)(4)b)(4) AsAs therethere isia nono specificspecific the past_ 1200 kg drug3rug codecode thethe thethe IntermediateIntermediate quotaquota isIs beingbeing requestedrequested forfor oripavineoripavine anoo wewe havehave beenbeen instructedinstructed inin Che past.. 1200 kg reflectsreflects modestmodest growthgrowth forfor thethe productproduct overover 2014.2014. Lc Vol. I Page 822822 •« APPLICATIONAPPLICATION FORPOR INDIVIDUALINDIVIDUAL MANUFACTURINGMANUFACTURING QUOTAQUOTA bate Submitted 29-APR-14 Roquaatequeet ID.|ll9S06ID.119906 hate Submitted! 29-APR-14 1 per PEA-IBS) ame of Das CClane or List 1 Chemical (only(only l_per._DSA.7189) Schedule /List Numbur X QRXPAVIMSRIPAVINE d tedllle/List Number 2 L PruEAEA RegistrationRegietration Number bX4),(b)(7XE) NO 0(6) ContactContact ParPersonasa h)(61mi L~I ex. No (b)(6) T= he tl«a No Smalltmail AddreAddress l|)(4);(b)(6)(b)(4),(b)(6) hone No. or Alfcaloldinot _se_S«lta> KQTBtNOTSt >11all DuamtlclepQuantitieu areare Coto belad EXPieeaodExp d Inin OramaGrano ofef AnhydrouBanhydroua Acid,Reid B«a«.Dame. or Alkalaid(not as Salta). QuotasQuotas PreviouslyPreviously 1Iosued_hyLACA Quota Requested 2013 2014 2015 Jucta: 110ta HistoryEistOry 2013 2014 2015 Quota Raqueated 19,000,000. 0 10,10,400,000.04DC( 000.0 10,712,10,722,298.0298.0 0.00.0 19,000,000.0 Eot 1 pa co for rear 3nd Preceding Year lot Preceding Year Eatlnate for Production Data 2nd Preceding Year lot Preceding Year Latinate tor satimsce for Year reoduction Data Requested CurrentCurrent YearYear sequeated InventoryInventory aeas of00 DecDec 2131 216,179 . 0 116, 17 9. Q 69,69,2E2.0202. C O.C0.0 316,179.0 316,179.0 a.a.BUlkSulk controlledCantrolled Substaocc/LintSubstance/Lint 11 Chemical...Chemical—. 3.0 0. O.C 00.0, 0.0 0.0 .1 b.ln-Proceoo Material 0 O.C b.In-Proceed Material O.C0.0 O.C0.0 0.0 0.0 O.C 216,179 316. 179 ,C c.c. ContainedContained inin FINISHEDFINISHED DosageDosage FormaForma 69,26260.202.0.0 0.0 316.179.0 316,179.0 >Disposition(Sale)/Utilizationimposition (Sale) /Utilization O.C 16,777,770.0 16, 777, 770. C 0.0 0 . 18,777,778,0 18.777,778.0 HI O.C aa.Dooestic.Domestic. O.CIo.o aa.c.c O.C0.0 0.1 b Exports . . . 16, 777, 778. C b Exporta 0.G0.0' O.C0.4 16,18,777,776.0777.776.0 18,777,778.0 VequieitRequisition/Productionion/ Product ion 0. 19. 000,000.0 19,000,000.0 0.o.d o. 19,000,000.0L 19,000,000.0 na.Eomentic. Cameatic SourcesSources . 0.0.0 00.t 19,19,000,C00.0000, COO .0 ' 19.000,000.019.000.000.0, IfIf tbsthe PurposePurpoas isis tato ManufactureManufaCtUre AnotherAnother SubstanceSubetancals1,I b) , FurnishFurnish chethe FollowingFollowing Information:Information: >r thla Furx>oa« % Yield HamsNana ofof HewNew EubutanceSubstance DrugDrug . Ax.201_yued for this Purplysa % Yield 22012012 i 20132013 I 2C152015 3,530. 34S 7.3S4.770 ,^100 18 . 777,778 77.00 3XYM0RPH0KEWYBORMORE CFCfl(PCB COWVERSIONICONVERSIONI 9662-A9652.A 3,530,345 2.854,278 a ,)61(%/10,T77,77S 77.00 I.W40. ?MI6 If05.5%.0(feLtrt.-1" # fif Betehoa Sot. Quantity Bat. Completion Tiao ProductProduct EnvelopmentDevelopment DaaageDemise Formform I StrengthStrength j Pnlts/BatchUnits/Batch T 0 de Beacham BatchBatch PurposePurses., let. Quantity Sat. Completion limo rrrnefnrTtanstar Registrant!Registrant ExplanationExplanation ofot transferTransfer V4 L Explanation CatDateo_ ofel DocDeutructionTtruetlonT Explanation • t of Pkga Fuxpoa • I Total Quantity PiCkagingPackaging Product far-Namea Strength | Pnlcs/PXqUnite/8%0 |I 0 a! Pkga Porpsoo 1 Total Quantity • • ROSaarksRemark* . . • • L Vol. I Page 823823 APPLICATIONAPPLICATION FORFOR INDIVIDUALINDIVIDUAL MANUFACTURINGMANUFACTURING QUOTAQUOTA teqUgSCest /D.120202XD. |l2Q262~ DateIpate SubmittedSubmlteedT 31-JUL-1431-JUL-I4 of Basic clase_or List 1 Chemical_(onlv 1 Der DRA-18911 ffohadulft/LlBt Number 2 LL 3RIPAV.INBIPAVIN2 Schedule/List_Number_ 2. nanaems endand AddressAddrnim ofof ReeiettantRegistrant PrueDrug CodeCoda 9330-0i»330r.0 (b)(4)(b)(4) 2uota3uota YearYear 20152015 • )EAPK RegistrationRegloc ration Number(b)(4),(b)(7)(E)Number (b)(4);(b)(7)(E) ~onnap-t.ontact PeragnParaon](b)(6)(b)(6) PaxPax. NOMo (b)(6)(b)(6) Smallall AddressAddress 'h)(41t'hlC4. VChlfai (h)(6) r 241orlephone No.No. Kora.mots i AllAll QuantitiesQuantities aroa*u toto beba ExpreesadgxpreBSad InIn Ora=On ofof Anhydrouatohvdtou. Acid,Acid. name,B«««, oror Alkalold(netAlXalotdlnot as» Saito).S.lt.l QuotasQUOt PrevieuslyPreviously IssuedI sailed byby DEADEA Quotauota HiutaryHistory 2013203-3 20142014 20152015 QuotaQuota ReQueetadRequested 3,124,000.03, 126,000.0 3,202,650.03 , 293 , 650-0 0.00.0 6,231,000.06,231.000.0 ProductreductionIon DataBafcn 2nd3nd PrecedingPreceding roarvoar :or•oc PrecedingPreceding Yeartfear estimateBatinaeo forfor Esti..teBatlcatu forfor VeerY«*r CurrentCurrent YearYoar RequestedRogues ced InventoryInventory asas ofof DecDec 313i 0.4O.C 0.ro.c 2,176,000.02, 176, 000 . 0 2,176,000.02, 176,000,0 caulka. Bulk ControlledControlled Subatance/ListSubstance/list 11 chemicalChemical... 151.100.0151,100.0 0O.C t 0o.c O.o.c b.In-Processb. In-Proceaa MaterialMaterial 0.0L0.0 0-Co.c 0.0.0 0.0o.c c. ContainedContained inin FINISHEDFINISHED Doeage Forms c. Doflage Forms 151,100.0151,100.0. 0O.C C 2,176,000.02. 176,000.0 2.176.000.02. 176,000.0 JlapoeitispOsitiOn(Sale)/UtiliZAtiOnion (Sale) /Utilization 4,676.7054,676.70; 0.0O.C 3.616.000.3. 616.000. 13,,616,000.0616. 000. C a.pomestica. Domestic 0,0750.07; 0.0O.C 350,000.350.000, 350,000.03S0, 000.0 hb ExportsExports 4,676,704 ,676 .71 0.0O.C 3,966,000.3 , 966 ,000. 3,966.000.d3, 966. 000. C &ccguloitionisroductiongu i s i t Ion/ P ro due tion 2,001,510.2.003, 510. O.C. 55,151, 151 000.0000.0 5,151,000.05, 151. 000. C a.Domestica. Domestic SourcesSources,. 22,003. 001,510S10 0 0,O.C 5,1515,151, 000.0000.0( 5,101,000.0S. IS 1.000.0 Iff thethe PurposePurpoae leIs toto ManufactureManufacture AnotherAnother Substance(e),Substance (e) . FurnishFurnish thethe FollowingFollowing Information;Information? NameMaiaa ofof HeyHaw OubstencoSwfeetanca DrugDrug AmountAnount usedUsed forfor thisthis PurpooeS*urpouc t6 YieldYield 20122012 1 .2013.2013 I 20152015 <*DRCM0RYDROMORPHONEPHONE 9150-0siso- o 1,140,2201, 140, 220 1.965.1,965,4400.00.243« 2,564,000‘'2,594.000T7' 76.00TB-00 btiorw02€> y^v n\.oK<,-(7A-e$•-e--^ 2,60°Z,c>oc> _.) ProductProduct DevelopmentDovelnpifcQPt DecaysDgonja FormFonaj StrengthStrength I| Unita/BatchUnite /batch I 6I ofof HatchemBatches Betel'Batch POrp0611Purpaaa Eat.But. QuantityQuantity [Eat.Eat. CompletionCompletion TimeTime L izanrforxansfor RaglatrantRaglatraat ExplanationExplanation ofof 7reneforTransfer DataPato ofof DeutructienPoptructica I ExplanstienBxplanatl on Packagingackeging ProductProduct HamaNana StrengthStrength [ gaits/Pk.;fnita/Pkq 1[ I% ofof Pkg.Pig* PurpoesPurpoae i Total Quantity ternariesemarks 3,616,000,616,000 grams forCor converalonconversion to hydromorphone, Logoboss on production estimated at 1.405,0001.405,000 gramsgram® 1,0001,000 gramsgrans forfor oripavineoripavlne referenceeference atandards/conversionstandards/conversion toto hydromorphonehydroiaorphone forfor referencereference standardsstandards Replaces application reference4119630reference# 119630 L Vol. I PagePage 824824 1 APPLICATIONAPPLICATION FOR INDIVIDUAL MANUFACTURINGMANUFACTURING QUOTAQUOTA Raquaatequest ia.|ll9606ID.i119606 batatuts Submitted IL 30 -APR--APR-14IT ame of Basic glaaaClaIIe or List 1 ChomtcalChemical {anlvla lv 1 uarnor DEA-18S1EA-1891 2 aeiPAv..iNsTPAVINE S.eSchediagiLletho iJuJLoZL taSLjiu»hs!C. Number t____---- c Uamn nnri MrtrnHa of Heglncrant pruaDrug CodaCode S>330-t>9330-0 amp and Address of Reaistrant (b)(4)b)(4) Juotopuota Year 20152015 DEA)SA RsglaeraclonRegistration NumberNumber(b)(4)0X7YE)(b)(4);(b)(7)(E) contactontect Pergontb)(6)Porno bX61 I FIX.Fax, HONo (b)(6) Phone No emailail AddraaaAddress |7hWWhVfiVFIV41(hVRI L _Phone No. WOTEiwarn Allall Quantities areate toto bebe ExproHBdExpressed Inin OraasGraze ofor AnhydrousAnhydrous Acid,Acid, Baaa,Bees, qror AlkaloidAlksloid(nac(not asas Salts)Salts). QuotasOuotai Previously Inloaneda vied byby PEADEA •Quota Requested juotnatm HistoryHiotery 2013 2014 32015015 'Quote Requested 1, 000,000.0 too,700,ooo.o00D-0 €12,417,500,05C0.0 0.0 1,000,000.0 2nd Preceding Vcar lor preceding rear SatinetsSas/mace for£er £stlnat«Setimate for Tee*Year Productionreduction EataData lad Preceding Year lam Preceding Yens CurrantCurrent y*urYear RequestedRequested Inventory as of Dee 31 nventory as of 0.C 1, 400,000 .0 1,400, 000. < 324,264324,264.0.0 0.0 /400,000.0! 1,400,000.0 a.4.13ulkBulk Controlled Substance/List i1 Chemical...chemical 0.0o.a 0.0 o.c0.0k c.c.o b. In-Proceaa Material P.M-Process Material 0.0o.o o.c0.0 o.c0.4k o.o0.0 c. Contained in FINISHEDFINISHED DosageDOsage FormaForms...... 324.264.0 O.C0.0 1.400,000.01.400,000,0 1.400,000.01,400,000.0 -a I 3iapoeition{Salelisposition(Sale)/Utilization/Utilization 000, ( 6?67.0 0.0.0 1,1,000000,000. 000. 1,000,1,000,000,E a .-DomesticDomestic 0.0.0 0.0.0 0. o.c0.0 bb Exports ...... 67767.0 0.0.0 11, 000,000.000 000 1,000,000.0 icquinltcquisition/ProductiOnion/Production 337,581.0327.581.0 0. 1,000,000.01,000,000. 1,1.000.000.0POP, 000. C a.a.DomeaticDomes tic Sources..Sources 327,327 S61581 . 0 0,0. 1,000,000.1,000,000.0 1,000.000.01,000,000.0 It the Purpose is to Manufacture Another SubatancelaJSubetancelal,, Furnish the FollowingPolleving Information;Information, S Yield Nae*llama of HewHey SubstanceSubatance DW3Drug AaountAmount PflfidOs d tor Chiph1 Pu 8« % Yield _, 30122012 22013013 51 2015 0 500.000 60.00 Juprenorphioeuprenorphine base 0000-0oooo-o 0 0 500,000 50.00 500. 000 50.00 Suprenoxphineuprenorphine HClNCI 0000-0ooco-o 0 0c 500.000 50.00 Batch Purpose' Ket. Quantity |ejC. Completion Tine -ProductProduct Development Dosage PermForm I StrangStranythth I Unite/Batchwilts/patch •4 of Batchespatched eatah Purpoili Mgt. Quantity 16at. Completion Tina rreaaferroaster Registrant ExplanationEsslanstioa of TransferSranefer OttoDate of DeeDentructlonftraction! Expleuatiosg>plep»Clon Purpoao j Total Quantity Packagingackaging Product FaceDana StresgtaStrength PBltfl/PAgUnita/skg I| I ofCf rkqerfcga' Purpsau Total gusetity leaark*emarke ... iultistepultistep conversion of intermediate purchased from a cmoCM0 against procurement quota toco BuprenorphineBuprenarphine basebaae and 8uprenorphineBuprenocphine HClCl against manufacturing quota. L Vol. I PagePage 825825 w• APPLICATIONAPPLICATION FORPOR INDIVIDUALINDIVIDUAL MANUFACTURINGNANUPACTURING QUOTAQUOTA RequestRequest iri.ID.118690.Iiiesso . batsbate gubgletedSubmitted!I 22T7 -MAR--MAR-141 4 pane of Basiq_Claee or LioWilomicaLionlylnor12E111201 Chemical tonlv 1 par PEA- 18 9) 9RIPAVINg3RIPAVIHE Ichedule/Llflt _RmeiborNumber 2.2 LL >rpg. .Coda laiJJjiO. Hajietape andand AddrepaAddress ftof "vqi-PtffBntRegistrant 9330-0 (b)(4) Datauata YearYear 20152015 ISARA RegiotrationRegistration Numbermumbar(b)(4),(b)(7)(E)(b)(4);(b)(7)(E) l.- Contact PQ eon (b)(6)b)(6) Fax,.ax..Hy No (b)(6)bX6) gmail Address 'h»4Wh»fSI> > phemane MO.No _ KoTEROTE'i Allall Qnanc.lt.loflQuantities aroare toto 5.be XAorooBodZagregeed inin QrnpBCrams otof AnPvotQuakneydrous Ada,Reid, 9.see... ator AllaloMlnotAlkaloldinot flflall 3flltolSalts) Quota*Quotas Ptoviouolypreviously IssuedIssued byby DEADEA 2015 Quota RoquoMtod JuotaQuota HistoryRiotory 20112013 20142014 2015 Quota Requested 0.00.0 430,430,000.0000.0 0.00.0 1,000,000.01,000,400.0 Egtlnstu for Eoelti&tc for year Production DataData 2nd2nd ProccdtngPreceding YuarYear latlet PrectdinoPreceding y-nrYear Eetleota for Estivate for Year currentcurrent yearYear 1 Requestedlequented Inventory asas ofof DecDec 3131 0.00. C0.0.0 23,23,000.0000 k 23,000.023,000. a.BulXa.nulx controlledcontrolled Substance/Substance/ListList 11 Chemical...Chemical..., 0.0 0.0• 00.0.0 0.CO. b.ln-Proceseb.ln-Pracess MaterialMaterial 0.0 o.c 0.0Q, 0.0O. 0. 0 0 cC.. ContainedContained inin FINISHEDFINISHED DosageDosage FormaPores 0,00. 0.00.0 23,000.023,000.0 2323,000., OOQ . C DispositionOiSposltion4Salel/Qtillzacion(Sale) /Utilisation 0.0o. 0.0.or 1.103.000.01,413,000.0 1,103,000.01,403,000. aa.Domeattc.Domestic, 0. 0.0 0.0 0.0. 0.0 0.0 O. b ExportaExports 1,403. QOD.O b O.Co. 0.0.0 1,403,000,01,443,000.0 1.403.000.0 ftcquisition/PraductAcquisition/Productionion O.C0.0 O.C0.0 1,000,000.01,000,000.0 1,000,000.01,000,000. a.Domentica.Donentio Sources...Sources 0.00.0 0.00.d 1.1 000,000.0000 000.0 1,000,000,01 000 000. t If thethe PurposePurpose i»is toto ManufactureManufacture AnotherAnother substanceSubstance(s)ts) , PurniehPurnieh thethe FollowingFollowing InformationsInformation; \ Yield ft/annSame ofof N«»New Substancesubstance StvgDrys AmountAmaw ill2Lia:m1.Quad £oz thifl2411 1 1'9EPolisPuryoaa % Yield 2Q122012 " I 20332013 II 20152015 . Quantity jBae. Coapiatlon Tina ProductProduct DevelopmentDevelopment OcaageDosage PcnrForm . Strength UnitHVoitn/Batch/Batch «0 ofof BatchesBatches BatchBatch PurposePurpose I BitRat. Quantity Bat. Completion Time ...,0 Transferranefer Registrant II ExplanationMagianstion of Tr#njfTransfer.O* , c • . . Date of Dentructiooneetructioo [1 BjcplanationExplanation Total Quantity Packaging Product KaneName Strength |I Onite/PhgVnita/pkg | Ili of Pkga I _ purpoaa70r00ae Quantity I 1.1f.tal Remark°Ramarku , 7^ 103.000g103, QOOg iaLe planned for use 1nIn 'Hydromorphone"Hydromorphone and 1,100.0009l,100,000g is planned for use in Oxymorphone. li 2.4.3t5V__s) • t Lc Vol. I PagePage 826826 DarlaBads Class:Ctes*: 20152015 InitialInitial APOAPQ WeWo TotalTen P0I PQ ReglAcqc 5.0005.000 "1.141) FDAFCAEat; Est; IMSIMS Est:Esl: VANNfTnrrnan* Aar...! DEAnf A NumAlun 29152015 RequestedRequested MCIMQ 2014W14 RevisedRcvtetd MCIMQ 2013201JS»lr* Salt 20512013DEA DEA MOMQ SalesSale* %*gf of 2012 Salta Snare as 2015 Tan' PO 2013 Lrivitistory ecila Paltered Exports 2014 Projected Sara Acij Avail Cale Cale Using CFR SO% avant MO 2013 Sate* SMr* or 2015 Total pq 231Jlnv*nloiY 2014 Projacud Enporta 2014 Pnijaettd Sates Aoj A**4 Cilc Cale Uaing CFA SO* Irwonl MQ (b)(4);(b)(7)(E)(b)(4),(b)(7)(E) 5.000s.coo • aweo.ooo 0.000 5,624,322.050 0001:1 0000 0030 0.000 4000 0.000 4.020 5 000 0000 5.624.322OO0 o.oco 0.000 O.COO 0000 4 000 0.000 4.M0 6000 3,000,000.0003.000,000.COO 6,157,639.0005.1 57,639 000 5,624,3220005,624,322 COO 5624,322.000S.624,322 000 1.0001.000 5.0005000 972,579.550572,879.000 DODO0 000 2,507018,0002,807.018.000 5547,808.5005.347,888500 -2,784804.000-3.764,064.000 3,000,000.0003,000.000 000 3,000.035 6.157,530 000 3000,005.000 MOMQ Tanta!Tauter 3,000005.000000 6.167.B3H noo 3.000,005 000 20142014 FinalFlml Yt15WWJtel APQ:APa* 7,400,000.0007,400.000 000 20142D14 FinalFinal RasRavlaad,14441APC0APQ: 0.0050.003 FDAFDA EatCat; 12014(2014 InitialInitial APO'APQ % t 1• FDAFDA Eta)!Et«): 7,400,0000007.400.DD0 000 IMSIMS r.5e:Cat: 1281i[2PU InitialInitial APOAPQ •- 11 • IMSIMS Est):Eat): 7,400,000,0807.-00.000 000 APOAPQ sufficientsufficient, nono adjustmentadjuatrrem rerequiredquires! OXYCODONE (FOR{FOR CONVERSION) Vol. I PagePage 827 C r r 2 |5 3 « 2015191641 APO si 2 2 35 5 3 3S .. Bask C1ass:s2 110241 Worksheets s sl 2 ui si 11 2 § « Slunitlf 301$ is? t*s°§ o | | I !§»> % 2 g w g * a s 1 2 | 2. a i > •f I z 1 iiill 2 2 I i S inn 4 3 Hill £ slits 1*3*1 ri s & i 2 Company2 > DEA Num£ 7015 Requested 00 2014 RtViged 110 3013 5Ades 2013 DEA 02 Alma %612013 Sates Total PQ 2013 Inkreedery 2014 Projected Expel*/ 2014 Projected Sales invintory Adj Aral! Cak SO% (mune MCI 1 "S8« 8 8 czr E e. ° stss o i §3§§ H ° §111 (» r> 1 5.000 0000 ' 7,793.780003 0005 aoco 0.000 0000 4,000 1.000 0.000 4000 5030 0.000 . » 8 b~ S 5 S fl o § ? S 3 • ffl 5 n (b)(4);(b)(7)(E) ai *i" at o S a 8 - S 1 I S E 16000,000.000 11200.000000i 8,300,588.000 7,793,768000 6869 5031159.477 1.579.762.000 0.000 10.812.103000 1.731050.000 9,859,521.500 20058,79030 13068,790347 § 8 i O d § E- w ° ii; * « o 1 1,000.000 0.000 0.000 7,793.769,000 0010 0.000 0.000 0.000 1000.000 0.000 0 000 1.000.000 1,000.000 ^ 2 I s 8 APPLICATIOMPORAPPLICATION POR INDIVIDUAL WUTOPACTORINGMANUFACTURING QUOTA Requestcomsat ID.1119501ID,|ll3S0T i [DataGate Submitted 2929-APR-M-APR-14 fame of• BasicBaale Clau_sr_,LiatClftnn or Lint 1 Chemical(only tonlv l_mor1 per DEA-1091P&A-X89) 0 •XYMOSPNONRJXyWORrHQM B (FOR( fOR-CONVERSION)CQPVERS ION)- . Scheduls/LlBtCheduleiList HumberNumber SL fameAna nnriAnd AdelroomAddrnnn ofnf RecriotriaRpqinfrrnnt t Drugrug CodeCoda' 9652-A (b)(4)(b)(4) luotauota rearTear 2015 iEARA Registration Number(b)(4),(b)(7YE)Number (b)(4) ; (b)(7)( E ) Contactma g 15 41thl(R1 I 'ax.a NoNg (b)(6)(b)(6) fcaall1 AddreaaA r KbV4V(bV6i(101(41(101(61 I ihsaa JS9 tfOT2»NOM All OuantitleaQuancitioe aroare to bobe lixpreassdZxpraoaed inIn DramsCrama ofot Anhydrous AcidAcid, BaseBass, or Alkaloid,AlCaloidUnat(not as•• SaSalt* tel.1 . Quotas PrevicuslyPreviously Issuedl9auad by DCAOCA •Quota eta History 2013 2014 2015 Quota Requested 9,400,000.09,400, 000.0 11,300,000.0 0.0 16,90016,900,000.0 000 0 fftts-raace- for HatimAceBeitiMate fortor rearYear Productionreduction Data 2nd Preceding Year 1stlac Preceding HearYear estsoate.for Current 'rearYear sequestedflequeeted Inventorynventory as of Dec 31 1,579,762.1,579, 762. < 0.O.C 737,633.073"?. 633 .0 737,6330737,433 ,0 0.13141ka. Bulk Controlled Substance/ListSubatance/List 1 Chemical... O.o.< O.0.( 1,000,000.01,000, ooo.o 1,000,0001,000,000. 0 bb.. In-ProcensIn- Process Material O.0 . ( 00.0 O.o.c O.0.0 Dosage Forme c. Contained in FINISHED Dosage Forms...... 1,579.762.1,579, 762. C 0.0-9 11, 737737, 633.0633 .0 11, 737737,633. 633 0 •lspositionlEalel/UtilizationDlspo<ionlSalu} /Utllizat ion 0O.C O.•O.O 16,632,103.16. 932, 103 .0 16,032,103.016, 932", "103.0 a.Derneatiea . DoroeBtic . . O.O.C 0.•O.C 0.•O.C 0.0.0 b Exports b Exports. l O.C 0,•0.0 1616, 832032, 103.0 16,832,101.016, 832,103.0 . L \cquicquisition/Productlong icion/ Production 0. O.C' 16.900.000.016. 900, 000.0 16,900,000.016,900.000.0 a,DOmeSC1Ca, Domestic SourcesSources.. ' 0. O.C 16,900,000.016, 900. goo.c 1616. 900900, 000OOO.O', 0 0.. O.q 1 Lff the Purpose isi9 COco Manufacture Another Substancele),Subetance (e) , FUrniahFurnish the Following Information; Vu&oNemo of NewMew substanceSubstinCo Drug tegMtAmount UflgdUsed for this PuPurpoa* ea.& tH VieldYield 2012 i 2013 1 20167015 WROXVMORPitONEOROXYMORPRONS (FOR(FOR SALESSALE> 6666-B3660-2 0 0 6,707 63.00<3 .00 'OROXYMORPROSSsOROXYWORPHOA'B (FOR(FOR CONVERSION) 9666-A966 S-A 3,328.9523,326.952 4,333.939 14,025,39616,625,396 63.0063 .00 Productproduct DoVallbrheatDevelopment Dosagepostage TOMOrona StrgnStrength Oaica/Batchalca/atitcri *f of BatcbaBpatches Batch Purpose Eat.Bat. Quantity |E«c.Eat. completionCompletion TineTime c •Transfer wieder RegistrantAogietrant Explanation of Transfer Date of Deetruction]DBBtrUCCiOD ] trplanationexplanation •'ae &akagin;keg log Product Name Strength 1 CaitaiNcgCnlts/Pkg | 69 ofot PkgaMfrs Purpose 1| Total Quantity Remarksrke • Lc Vol. I Page 829 f a APPLICATION FOR INnzvrimALINDIVIDUAL MANUFACTURXNGMANUFACTURING QUOTA RequestSequeet IID.119502.11 19 SOB beteate SubmittedaubmlttedT 2929-APR-14-APR-14 ijame ofgl Basic3n aig Clasp(?lann oro r ListLint 11 Chemical (onlytonlv 1I oertier DNADBA-1891-1891 NONXTMORPHONEMOBOXYMORPHfiNB (FOR(FOR CONVERSIORICONVERSION) pohodolo/LiotichcdulB/Lint; ymifeftrNumber A.0 Nam {ContactContact >PBrBon|(bK41 (b)(41 px.'fl*. NO (b)(6)(b)(6) pmaiLgypij AWrees.Addrooe (b)(4)(b)(6)(b)(4);(b)(6) .Phone^ae No.Wo 90111HOTEi All OuancitioaQUelsCitided areait to b Jot Preceding Year LatinateEociute fortor PearYear Production DateData 2o42nd Preceding Year let Preceding Year EstimateEocloate for Current Year Re Inventory as of DecEtc 31 745.525.0745.525,0 O.0.C 1,230,032.0 11,230,032.0,230,032.0 a.Buika. Bulk Controlled Substance/ListSubstance /List 1I Chemical...Chemical . . . 318,905.0310, 505 . 0 0.10.C 1,314,035.0 1.31», 314,4.035.0035 ( b.rn.procese Material ' b. in-proeeae Material 0.a0.0 D.0.C 0.0 0.00-( o.c. Contained inIn FINISHED Dosage Forms ...... 1,064,034.01,064, 034 . 0 O.0.{ 2,544,067.0 2.544.067.02.544, 007. < Dispoeition(eale)/UtilieetionJlaposition (Sale) /Utilization 0.0 0.e0.C 8.170.000.06. 170, QOO.O 8,/70,000.0B, 170, 000.0 a. Domestic o.Domeatic G.0o.c 0.6o.o1 0.0 a,qo . c b Exports . , b 0.0o.c 0.00.C 0,170.000,08, 170, 000, < 0,170,000.03,170,000,0 ..., AcquialeiOn/PrOduCtionAcquisition/Production 0.00. 0.00. 10,600,000.410, 600, OOP. 14.600.000.g10,600,000.0 a.Domeatica. Domestic SourcesSources.. 0.00 0.00 10,600,000.010,600,000 10,600,000.0 ._. IfIf the Purpose it to Manufacturemanufacture Another Substance(s),substance ---671CTiS Prod:actProduct DevelopmentD»v«lapa«nc DosageDoaaga ForaFern EltrallgthStrangth 1 UnitedVelitf011itChant eh I It of aatehaeBittehafi I hatchbatch PurposePurpooe I Eat.Est. Quantity [tat.Est. CompletionCenplotion TimeTiom e Explanation of Transfer traneforrranafor Registrant I| •. DsteDate of Destruction1DoflCruc tloo j_ Explanation FackagingPackaging Product Hem.Koto* I Strength I| Unlte/PfcgVoite/Pkg | f* ofOf rkcaF*go I PlaRp0m6PatpCaO ^1 Total QuantityQuantity" . . 'RemarksRemarks Vol. I Page 830 APPLICATION roxFOX INDIVIDUALINDIVIDUAL MANUFACTURING QUOTA NeguestEegweot ID.1119509ID. 1119503 patetoatB SubmittedSubmittad | 2929-APR-14-APR-14 K.lama .13 of Basic ClappPlana or iteplist 1 Chemicalhg 1, al (only 1 earpar GRAQBA-1B<)) -11391 NOROXYMORREQNE {FOR. SALE) ISchodule/LlBtSchedule List Number Qo c Fame and Addressftdflrggg Ofif RerietrantPg<7lgcr»nt Gruarun CodeCoda _____SS6O-A9668-B (b)(4)(b)(4) Quotaluoca Year 2015 DEAJEA Registration Humber|(b)(4);(b)(7)(E)Number(b)(4)XIDX7YE) ;oDtactIqntact PereonthVRIParson 'h»m II ^ax.ax. No (b)(6) ?mail Address b)l4i:(b)l6)b)(41(b)(6) Phone NoKo SorraNOTE) )11All OusatItiaaOuantlUai areon Coto bobe Expressedtxprooooil Inle aromaOtooo ofot anhydrousAntvdrouo aeldLjlHeld, Bw,e,er or slasAlt»lold Iff the Purpose isla to Manufacture Another Substance(s).Subatance<3) , FuriiiithFurnish the FollowingInformation;Following Infonriation; KuaoNano of HowNee SubotancsSufcotanca •' Drug amountA«oun_t_Pfled Heed for thisthio PurpCfleYu ae %I Yield 2012 2013 20IS 2012 1 2013 J 2015 ProductProduce DevoiopmentDevolop&aat DosageDcaaga Poemrone Strength.Strength Units/BetebUnite/Batch Ifl ofo( betcheefi»tch«« Batch PurposePuxpgeo Ij rat.BSC. guautityQuantity jget.rat. Coapletlpncoasyletton TimeTiro« I Tranetas"ranafex Sagiotrantriglatrarit ExplanationExpleasttem of TransferTr/motet Pata,Date _otof DeitxuctloaDestruction TI ExplanationamUMtlgP PackagingPackaging Product NameNano I . Strength I Cnlta/PkgUnita/Pig 4f of PkgsPkgo PurposePurpoaa I Total Quantity ]remarksReaiarks L Vol. I PagePage 831831 APPLICATIONAPPLICATION FORFOR INDIVIDUALINDIVIDUAL MANUFACTURINGNANUPACTURING QUOTAQUOTA Requestijaauaat ID,ID.1197801119790 bateate SubmittedSubmitted I 02-HAY-lT02-NAY-14 TameName efof Run-ir.Basic ClaaaClaes oror LiatLint l1 ChemicalChemical (only 1: . peg.oar PBA-199)DRA-189) OXYMORPRONE3XYM0RPHCHB (FOR( fOB— CONVERSCONVERSION)I QN ) — — AChedule/LiatSchedule /Mat NumberNumber Si RamaSame andand AddressAddress ->tof RegistrantReatetrant PruqPrua Co4eCede 965P-A9652-A c Ouota laar 2015 (b)(4)b)(4) Quota Year 2015 deabEA RegistrationRegistration NumberNoedoer(b)(4)0X7XE)(b)(4);(b)(7)(E) Contact PBrBBnVb)(6i•:r:-, b)(6) I 'Fax.pax. NoNo (b)(6) PhqDB No BsalJ-AfldtepgEstai_ Kb)(4);(b)(6)b)(4)1b)(6) Phone No. BofsiUOTai AllAll QttaBtltZiSQuentitiee 5x5are toto bebe BuoroaaadErg d inis flmadrawn oofI AnhydrouaAnhydrous Aold.Acid,Jjgfl 13.T1, oror AlkaloidAlkaloid(not{not a. BftlflSaltel. fluQuoeaeoca a PreviouslyPrsvfouslo looucdIssued byby O&A0Th 20 IS Quota R©<|ueeted QuotaQuote HistoryHistory 20132013 20142014 2015 Quota Requested 0.0 0.0 0.0 1,000.0 lac Preceding Year Bacieuiee for EeclMte for Yea* Production DataData 2nd2nd PrecedingSreeedtns YearYear lac staccatos Year Rscieuts far Estivate far rear CurrentCurrent YearYear RfijuoatcdRequested InventoryInventory asas otof DecDec 3131 o.c0.0 Q.O0.0 o.cO. o.c0.0 a.a.BulkBulk Controlled Substance/LietSubstance/List 11 Chemical...chemical... o.c0.0 0.0 o.cO. c.oC.0 b.In-Prcccssb.In-Procesa Materialmaterial o.c0.0 0.0 o.cO. o.c0. C. Contained in FINISHEDFINISHED Dosage FormsForms o.c0.0 o.c0.0 o.c0 o.cO. DispositionDisposition(Sale)/Uttlizatton(Sale) /Utilizat ion o.co.ck 00.0. c 1,000,01,003,0 1,000.0 a .Domestic a.Comestic o.c0.0 0.0 o.c0.0 o.c0.0. b Exports b Exports o.c0.0 o.c0.0 1,000.0 1,000.0 'htcquisitequisition/Broductionion / Product Ion o.c0.0 o.c0.0 1,000.0 i.ooo.C1.000.0 a,0,0omasticDomestic sources..sourcea o.c0.0 o.c0.0 1,1,000.0000.0 1,000.0 If cheshe PurpcotisPurpose le co ManufactureHanufacture AnotherAnother SubstanceSubetance(s).(sj . Furnish the FollowingFellOwing Information! % Yield JJtuaaNemo of NewNew Substance Drug Aaouatkno :a UocdDead foefor zhiethis PurpoaoPurpose t Yield 2012 1I 2013 2015 Hatch Purpose Sat. Quantity* jBat. Completion tine Product Davslopcantnevelarment Coaagstroupe FormFora I 3tStrengthrang th II Onita/DacehQuits/Beech •f of BatchajiRetches Batch Purpose Hat. Quantity Bat. Completion fine rganafcgframafer RagloRegletranttreat jI ExplanationHs:planation of TransferTrampfer L • PateDate otof DeatrvctlpaDestruction r ExplanationI...tic. Total Quantity PaCkagingPackaging Productproduct Han#Rase Strength | Vnlta/PkgValte/Pkg |f 0I ofOf Pkg.Pkjs Purpose Total Quantity • Remarks toLa supportaupporc reference standards business ---' Vol. I Page 832832 'i A APPLICATIONAPPLICATION FORFOR INDIVIDUALINDIVIDUAL MANUFACTURINGMANUFACTURING QUOTAQUOTA 31 -JUL- H Request«quest ID.ID.F20272[120272 tPatipSate SubmittedSubmitted I 31-JUL-14 {isms»m« fitof BasleBasic ClassClass oror r. fantaetcontact ParaonPereo (0(6)(b)(6) pax.ax. NoNu (b)(6) 'hona NO gMail Address (b)(4):(b)(6)(b)(4).(b)(6) . _,phone No. . . >!4ftiMOTE* 111All SuontlkloiQuest/Cleo oreere toto bebe BamraaaadBxproomed lain OreaeOrem& oofC tohvdroui.enhvdroua told.Acid, Bairn,He_se, ocor »l*aIoldAlkeloid(notInoe a»eo salt.)State). Quctaauctae Previouslyre,' MI5. Y laaucd_ 86,20. byby PEA 2015 Quota Raquaated Suotapuota HlatOryHistory 2012202.1 20142014 2015 Quota Requested 3,3,010,449.W030,649.0' 2,751,000.02,7514 4200,0 O.O0.0 6,6,151,000.0151,000.0 lot Preceding Year Efltinate tor Eactraatc 14 r Year Productiontproduction DataData 2nd2nd PrecedingPreceding YearYear tot Preceding Year detieste for Hartnett 'Or Veer CurrentCurrent YearYear RequestedRequeated inventoryInventory asas ofof DecDec 3131 269,660269,680.0. 0 0.00.0 1,1,663,000.0663, OQfl .0 1,663,000,01,663,000.0 a.a.DulkBulk ControlledControlled Substance/Substance/fiatHat 11 chemical...Chemical 0.C 0.00.6 0.00.0k 0.00.0‘ 0.0 b. In-Process Material, b.In-Process Material 0.00.0 0.00.0 o.o0.0 o.c0.0 c.c. ContainedContained inin FINISHEDFINISHED DosageDosage Porm3Forms 269,660269,600.0.0 0.00.0 1,1,663,000,0663 , 000 . Q 11.663,000.. 663, 000. C Disposition,DispositiontSale)/Utilization(Sale) /Utilization S, 130, OflO. 0 17.0177,017.0. 0 0.00.0 S.5,130,000.0130, 0D0. 5,130,000.0 a. Domestic. a.Domestic 1,1,416,201.0416,201.0 0.00.0 0.0.0 0.00.0 b ExportsExports 5,130,000.0 b 1,493,218.01,492,210.0 JL40.0 5,5,t130,000-,000.3000.01 5,130,000.0 Acquisition/ProductionAcquisition/Production 1, 317,096.0 0. 6. 151,000. 0 6,6,151,000.0151, 000. C a. Domestic Sources.. 1,317,098.0 0.0 6,151.000. a.Domeatie Sources 0. 6. 151,000 .0 6,151,000.0 1,1,117,098.0317,098.0 0.0 6,151,000.0 6,151,004.u ItIf thethe PurposePurpose iala toto ManufactureManufacture Anotheranother Subseaneesubacance(0,{a) , FurniehFurnieh thethe FollowingPolloning Information;Information, % YUid K*a«Nerve ofof NavNW aubniancaSubetent6 CrugDrug L AnountAmount Ooad(rasa forfor thlataimtHIpeseFuTpaaa % Yield 20122012 I 20132013 I 20152015 Batch Purpose . Sit. Quantity [Bit. Completion Tina ProductProduct DevelopmentDevelopment DesignDosage PeraPere StxongtbStrength Unltp/EBtChEmits/Batch fI ofof Gate*latcheshe a I Batch Purpose . pet. Quantity IBet. Completion Time franpfirTransfer aeqlatr»ntRediatrent [ Explanation of TrahafarTransfer L DataDate of gaddedtructiontmiction 1 Explanation Purpose | Total Quantity^] Packagingackeging Product NameVnme Strength palta/gkgVnito/Pkg |I tS of Pkqaekes I Purpose I Total Cuantity RemarksReworks productionProduction loss esteatimated'atimated 'at 31;00031,-000 grams 1,000 grams COco support reference standard business Replaces application reference#referencelf 119700119706 / Vol. I PagePage 833833 r r r f £ i I I E 043.00,34..-.I ?....1111) n Reclo,o...1 s Ulil 4434 8.4.115..si aj'H Hi m 1114 2514 1 * m 2 al! I i Cr.., .4ovIS Dona WU Gras1 NU. II 1013 Qr... Apr-11 Q4•14 S5 mm. 0,900 1,661 5,119 11:360 7,61 P5C-A0A 5132 P5C.o0A 3 t J Hi K I Ma/66x fa. 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CS*Wv3II.44.ruilw% .4%YOrw4 YeAnowi •it.-It l*1% 2,5.11 X C.....4.4 ...% y.,44...4.4 .11111, 1.,,,64,4 fcELtei lOUDi 10H En. Piipwiiit** ii.in X11106»pM',i.nots.n. T.«l11,72 1014 Est. DiTrAiliM1 4.)19 2014 £»-l.Di um. 2015 Ee. Ditpw«ia»i 22.VJ2 1014 Es, Dupes i4,H»14 119 29,3 E13, 1,1,7444i66i 21112 A*Burraze 10,7951019.5 A^cmAocrl?r I*M115,241 •a v. uninlevy AD 9,1?) 54%5110rfc®7OT in, ra roc, A1.17.44n4.:4 1491) 3S5:Tnismory-7[11o4.4.464 9.121 733" TBiI.4.1 t raz S.kb EU*A Total T-U tot* T«td T.UI 8.4423 1344.4. T.14.I 7'...1 . 4'7.1. 4. E.M. a...a T..7 T.4.1 "-'p4.145 Koo*«ro<1,1.464,- of w«. riww Um kj l"H, O-tjmA, T-JU. i.ASUki Hxcwktrwf la fit, m**. tx»Vy 1*^, Ouiy*. Tn«lL« uAMaW 14,46. 1".0414 •44p., LAN a, b,,ad, Owty44, T.411.. 4 'LLAMA 14r 4 001.., T•1411. 4. 414 Fr IV^ri^bn '''MAb'''‘.r'' LP'''KuB ' PYfaU"'"' " r u.. ilf».I. " KxD 1..r..Kt9 tua Hit Con-r*km P*Mrf|Wl*»Drut tiptir4 _ BaifUl13.416.64 K111 , Ybtd_likkl «.a4413 !..«*,»st4h KEGI K«a646E I *,»1,48 , KO Cm, rrin 1.44r11413n 11.41.21... ti,k174 11444 B.0 41u, KI01 1413 KO /QS 1 Calwar.14= VOL. Wn A4Jl Crenr61 • MirrtxK.r C«v»n4—> Mori*1111: too1114Tur forCi CamL*nJo«L 41.4.4n 2.46•74,164 lia Cowesr14., its. 999 949 191 Rjf% TfiT 7,216 MM c^aoaphhmC#S AOA . 111Q7 4I ITT39) UX ISO7511 i.'M1,110 199 CVSAlMte HI ItilS Oi> annual; if Ca4>» n 2 pw(b)(4) CfenfidrnfUlCznftdrntIal 7/M/201*76(2/ 2 014 f Vol. I PagePage 835 * I I o» 114,14 CO's: 20168 initial APO MOAKb 5 *) -2 if 3 IS Hs i FDA 641: . Na 76141 PO Peg2 3614,401.070 8. INISM Col: .006 r 2014 Projected a Cele Using CFA :6 U f? I fa ,1 9 s 2 s m I 3 I o 3 g H S s ! 1 ? 2 S p 8 2 U I § s. u I 5 2 i z 8 Elpolts Cate % g 30131owentory 2114 P.opmerd 2014 Ogoietted Sates tritorAory Adj Avail 50%159091 MQ « CompanyI DCA Num 2010 Framlytted SAO 2611 Revised 4.10 101 Sales 2011 CEA tACI 541e4 %Of 2013 900.1000.000000200 31tat• 012013 Tota1 PO ' U « kj si I o 8 In y „8 5.000 3000 0.000 33,,604004? ,5,50:9 0710 0.000 0.007 - 0.000 4.000 1.000 1.755 0243 5.000 3 (b)(4);(b)(7)(E)3 4 n i- 8 fl 8 ~ 0000 00E100 4.211 300092071y 4212 216.006 0.000 10.000 25426E 706.001 -245.590 60.000 O d t IU £ -5 H i 8 - « N S 5 fr )n 168.000.000 141.000.010 8,820000 v 6,814.001 23,6E12000 0.000 166,000000 25000000 125011.500 46,125.002 566000.000 0 » S Vj § Op? S 1 s (ft m sis s l. y ? 713,000.000Hs- GI 0.13311 001 413.633.000 1004E02.071 0.11$ 211,218.000 0.000 423.000000 295641.000 617,142000 471,501749 617,142000 • 0 i» J Ills. J Hs I p 8 i a f 1 •>! an 1 5 y 1,400,000.000'§ 2,810.810.000 2,802.150E00 3,604,302071 0.T77 7,80142..115044..1:643 1.132,591.000 0.000 1,442061E00 501,319000 2017.391150 1.714,360801 1,800.000000 O ' b - s .» p * I e »* in 1 M - « y 1000900i 3000000 41,930.080 9,404502.071 0.912 34.090.280 0000 1,000)000 0.000 28402315 1E015.915 1.000.000 » D >> I a s S.S! o § s Kl tr> i 8 i . y 381,000.000 3.601,000.000 1.182734.030 330405000? 3,684502071 0.092 111,19080 310739.000 0.0E0 1277,000.4100 1.120,154.750 402,703.410 1,181,734.000 ilifih,1 Dt 8s;ssn0i; (J : 81888888 S5 88888888s sli •2 Ifllpl I iiiiiiii o 3 QOOQOOSfih ililiiM" >£4Dta»»n!; s fl '8^3- 9§|§§3SSf SCSBBSSSt; an I flllllii! s-ss51>of , §§181818 gel's S liiiiiiis i5 y 1,120E00000i 210,000000 7,650.000 3004592871 0.003 7.578,570 298020.000 0.000 816.200000 275090.030 379371000 172,308,462 170,371.0E0 § I i * 8 § I MO Totals: 7,105.065.000§ 4.002015000 3,949,312.000 I a 3414 Fin.6 tAittat APO: eAT.,0,0(1.1.000* 2614 Foal RevIstslAPOt' 0.000 3 s | FDA Eat 110141n8141 APQ '5 4 FDA Egg: 8.202000.000o> P M » lit! 2 fill i Mil o> *! IMS Eat 12014uu 411141 AP Q• 1 4 MS Eau : 6.436840.000 201$ pd 40051 501227.0008 1011 Ardiad 1401' 4,062055.000 E|| 28 -1 ILO 414 dung||| e 169.549.737 2 i S I eat coded for APO 5,712,601.707Ills i I I i Apo solciant ftp} adjustrosrd reqvind > s I i X 8 OXYMORPHONE (FOR SALE)E O) CO CO CD Q 0) "D Vol. I PageC 836 L 20152015Establish Establish AdjustedAdjusted AggregateAggregate ProductionProduction QuotasQuotas andand AnnualAnnual AssessmentAssessment ofof NeedsNeeds •• SectionSection 306(a)306(a) ofofthe the ControlledControlled SubstancesSubstances ActAct (CSA)(CSA) requiresrequires thethe AttorneyAttorney GeneralGeneral toto establishestablish thetheproduction production amountamount ofof eacheach basicbasic classclass ofofSchedule Schedule II andand IIII controlledcontrolled substancessubstances andand forforthe the ListList 1I chemicalschemicalsephedrine, ephedrine,pseudoephedrine, pseudoephedrine, andand phenylpropanolamine.phenylpropanolamine. ThisThis responsibilityresponsibility hashas beenbeen delegateddelegated toto thethe AdministratorAdministrator ofofthe the DrugDrug EnforcementEnforcement AdministrationAdministration (DEA),(DEA), andand redelcgatedredelegated toto thethe DeputyDeputy Administrator.Administrator. •• DEADEA regulationsregulations allowallow thethe DeputyDeputy AdministratorAdministrator toto reviserevise thethe establishedestablished annualannual aggregateaggregate productionproduction quotaquota (APQ)(APQ) andand assessmentassessment ofof annualannual needsneeds (AAN)(AAN) afterafter reviewreview ofof pertinentpertinent informationinformation providedprovided fromfrom variousvarious sourcessources includingincluding DEADEA-registered-registered manufacturersmanufacturers andand thethe FoodFood andand DrugDrug AdministrationAdministration (FDA).(FDA). •• TheThe attachedattached FederalFederal RegisterRegister notice,notice, preparedprepared forfor youryour signature,signature, reflectsreflects thethe calendarcalendar yearyear 2020151 5 establishedestablished aggregateaggregate productionproduction quotasquotas (APQ)(APQ) forfor schedulesschedules II andand IIII controlledcontrolled substancessubstances andand assessmentassessment ofof annualannual needsneeds (AAN)(AAN) forfor thethe listlist II chemicalschemicals ephedrine,ephedrine, phenylpropanolamine,phenylpropanolamine, andand pseudoephedrinepseudoephedrine forfor whichwhich thethe UnitedUnited StatesStates hashas medical,medical, scientific,scientific, industrial,industrial, exportexport andand reservereserve stockstock requirements.requirements. ' •• AsAs statedstated inin thethe 20132013 FederalFederal RegisterRegister Notices,Notices, DEADEA continuescontinues toto addadd anan additionaladditional 25%25% toto thethe APQAPQ forfor schedule IIII substances and thosethose schedule II substances thatthat are usedused toto produceproduce drugs thatthat havehave a medicalmedical needneed (specifically, GHBGH13 and tetrahydrocannabinols)tetrahydrocannabinols) toto preventprevent potentialpotential drug shortage issues.issues. L • ExpeditiousExpeditious reviewreview andand publicationpublication ofof thisthis noticenotice isis necessarynecessary toto ensureensure anan uninterruptableuninterruptable supply ofof schedule II andand IIII controlledcontrolled substances asas wellwell asas listlist II chemicalschemicals ephedrine,ephedrine, phenylpropanolamine,phenylpropanolamine, and pseudoephedrinepseudoephedrine forfor thethe legitimatelegitimate medical,medical, scientific, industrial,industrial, and export requirementsrequirements of thethe U.S.U.S. • The following points provide brief explanations of the changes from the proposed revised AAN & APQ values: List 1I Chemicals: • OD is recommendingrecommending an increase in thethe AAN for ephedrine (for sale). The increase is based on increased domestic sales and import requirements from registrant applications and projected demand for allergy and flu season. Controlled Substances: • OD is recommending an increase in the APQ for alfentanil. The increase is based on the increased domestic sales and exports. • •• OD is recommending an increase in the APQ for cocaine. The increase is based on the increased domestic product which leads to the production of cocaine as a by-product. ^ • OD is recommending an increase in the APQ for codeine (for sale). The increase is based L on the increased domestic sales and exports. DEAJOD/ODQDEA/OD/ODQ 8/12/2014 Page I1 of 22 Vol. I Page 837837 •• ODOD isis recommendingrecommending anan increaseincrease inin thethe APQAPQ forfor codeine-n-oxide.codeine-n-oxide. TheThe increaseincrease isisbased based onon L thethe increasedincreased domesticdomestic salessales andand thethe needneed forfor increasedincreased referencereference standards.standards. •• ODOD isis recommendingrecommending anan increaseincrease inin thethe APQAPQ forfor dihydrocodeine.dihydrocodeine. TheThe increaseincrease isis basedbased onon thethe increasedincreased domesticdomestic sales.sales. •• ODOD isis recommendingrecommending.anan increaseincrease inin thethe APQAPQ forfor fentanyl.fentanyl. TheThe increaseincrease isis basedbased onon thethe increasedincreased domesticdomestic salessales andand productproduct developmentdevelopment efforts,efforts. . •• ODOD isis recommendingrecommending anan increaseincrease inin thethe APQAPQ forfor hydromorphone.hydromorphene. TheThe increaseincrease isis basedbased onon thethe increasedincreased domesticdomestic salessales andand exports.exports. . . •• ODOD isis recommendingrecommending anan increaseincrease inin thethe APQAPQ forfor levorphanol.levorphanol. TheThe increaseincrease isis basedbased onon thethe increasedincreased domesticdomestic sales.sales. . •• ODOD isis recommendingrecommending anan increaseincrease inin thethe APQAPQ forfor marihuana.marihuana. TheThe increaseincrease isis basedbased onon thethe requirementsrequirements fromfrom bulkbulk manufacturersmanufacturers toto supplysupply cannabidiolcannabidiol oror otherother marihuanamarihuana extractsextracts toto dosage-formdosage-form manufacturersmanufacturers conductingconducting productproduct developmentdevelopment activitiesactivities withwith thethe objectiveobjective ofof receivingreceiving FDAFDA approvalapproval ofof theirtheir products.products. • OD isis recommendingrecommending an increaseincrease inin thethe APQAPQ forfor oripavine. TheThe increaseincrease isis basedbased on thethe ' increasedincreased domestic sales and exports of hydromorphonehydromorphone and thethe non-controllednon-controlled substances naltrexone,naltrexone, naloxone,naloxone, and nalbuphinenalbuphine which utilizeutilize oripavine as thethe starting material. cL • • ODOD isis recommendingrecommending anan increaseincrease inin thethe APQAPQ forfor oxymorphoneoxymorphone (for(for conversion).conversion). TheThe increaseincrease isis basedbased onon thethe increasedincreased domesticdomestic sales and exportsexports thethe non-controllednon-controlled substances naltrexone,naltrexone, naloxone,naloxone, and nalbuphinenalbuphine whichwhich utilizeutilize oxymorphone (for conversion)conversion) inin thethe route of synthesis. ' • c DEA/OD/ODQDEA/OD/ODQ 8/12/20148/12/2014 Page 22 of 2 Vol. I Page 838838 L BillingBilling CodeCode 4410-09-P4410-09-P DEPARTMENTDEPARTMENT OFOF JUSTICEJUSTICE DrugDrug EnforcementEnforcement AdministrationAdministration [Docket[Docket No.No. DEA-393]DEA-393] EstablishedEstablished AggregateAggregate ProductionProduction QuotasQuotas forfor ScheduleSchedule II andand IIII ControlledControlled SubstancesSubstances andand AssessmentAssessment ofof AnnualAnnual NeedsNeeds forfor thethe ListList II ChemicalsChemicals Ephedrine,Ephedrine, Pseudoephedrine,Pseudoephedrine, andand PhenylpropanolaminePhenylpropanolamine forfor 20152015 AGENCY:AGENCY: DrugDrug EnforcementEnforcement AdministrationAdministration (DEA),(DEA), DepartmentDepartment ofof JusticeJustice (DOJ).(DOJ). ACTION:ACTION: Notice.Notice. SUMMARY:SUMMARY: ThisThis noticenotice establishesestablishes thethe 20152015 aggregateaggregate productionproduction quotasquotas forfor controlledcontrolled substancessubstances inin schedulesschedules I1 andand IIII ofof thethe ControlledControlled SubstancesSubstances ActAct (CSA)(CSA) andand thethe assessmentassessment ofof annualannual needsneeds forfor thethe listlist II chemicalschemicals ephedrine,ephedrine, pseudoephedrine,pseudoephedrine, andand phenylpropanolamine.phenylpropanolamine. (b)(6) FORFOR FURTHERFURTHER INFORMATIONINFORMATION CONTACT:CONTACT: ExecutiveExecutive Assistant,Assistant, OfficeOffice c ofof DiversionDiversion Control,Control, DrugDrug EnforcementEnforcement Administration,Administration, 87018701 MorrissetteMorrissette Drive,Drive, Springfield,Springfield, VAVA 22152,22152, Telephone:Telephone: (b)(6)(b)(6) SUPPLEMENTARYSUPPLEMENTARY INFORMATION:INFORMATION: LegalLegal AuthorityAuthority SectionSection 306306 ofof thethe ControlledControlled SubstancesSubstances ActAct (CSA)(CSA) (21(21 U.S.C.U.S.C. 826)826) requiresrequires thethe AttorneyAttorney GeneralGeneral toto establishestablish aggregateaggregate productionproduction quotasquotas forfor eacheach basicbasic classclass ofof controlledcontrolled substancesubstance listedlisted inin schedulesschedules II andand IIII andand forfor ephedrine,ephedrine, pseudoephedrine,pseudoephedrine, andand phenylpropanolamine.phenylpropanolamine. ThisThis responsibilityresponsibility hashas beenbeen delegateddelegated toto thethe AdMinistratorAdministrator ofof thethe DrugDrug Enforcement AdministrationAdministration (DEA)(DEA) throughthrough 2828 CFRCFR 0.100(b).0. 100(b). TheThe Administrator, inin turn,turn, haShas redelegatedredelegated thisthis functionfunction toto thethe DeputyDeputy Administrator,Administrator, pursuant toto 2828 CFRCFR pt. 00 subpt.subpt. R, App.App. BackgroundBackground c TheThe 2015201 5 aggregateaggregate production quotasquotas andand assessmentassessment ofof annualannual needs representrepresent thosethose quantities of scheduleschedule I1 and II controlled substancessubstances and thethe listlist II chemicals ephedrine, 11 Vol. I Page 839839 in the United States in 2015 to LL pseudoephedrine, and phenylpropanolamine to be manufactured in the United States in 2015 to provide for the estimated medical, scientific, research, and industrial needs of the United States, lawful export requirements, and the establishment and maintenance of reserve stocks. These quotas include imports of ephedrine, pseudoephedrine, and phenylpropanolamine but do not include imports of controlled substances for use in industrial processes. On July 2, 2014, a notice titled, "Proposed Aggregate Production Quotas for Schedule I and II Controlled Substances and Proposed Assessment of Annual Needs for the List iI Chemicals Ephedrine, Pseudoephedrine, and Phenylpropanolamine for 2015," was published in the Federal Register (79 FR 37772). That notice proposed the 2015 aggregate production quotas for each basic class of controlled substance listed in schedules I and II and the 201520 1 5 assessment of annual needs for the list I chemicals ephedrine, pseudoephedrine, and phenylpropanolamine. All L interested persons were invited to comment on or object to the proposed aggregate production quotas and the proposed assessment of annual needs on or before August 1,1, 2014. Comments Received Five comments from DEA-registered manufacturers were received within the published comment period, offering comments on a total of 32 schedule I and II controlled substances. No comments were received for the list I chemicals ephedrine, pseudoephedrine, and phenylpropanolamine. Commenters stated that the proposed aggregate production quotas for 1-1- (1,3-13enzodioxo1-5-y1)-2-(methylamino)butan-( 1 ,3-Benzodioxol-5-yl)-2-(methylamino)butan- l1 -one (butylone), 1-(1,3-Benzodioxo1-5-y1)-2-1 -(1 ,3-Benzodioxol-5-yl)-2- (methylamino)pentan-(methylamino)pentan-l-one I -one (pentylone), 2-(4-Bromo-2,5-dimethoxypheny1)-N-(2-2-(4-Bromo-2,5-dimcthoxyphenyl)-JV-(2- methoxybenzyBethanaminemethoxybenzyl)ethanamine (25B-NBOMe), 2-(4-Chloro-2,5-dimethoxypheny1)-N-(2-2-(4-Chloro-2,5-dimethoxyphenyl)-Ar-(2- methoxybenzyBethanaminemethoxybenzyI)ethanamine (25C-NBOMe), 2-(4-Iodo-2,5-dimethoxyphenyl)-N-(2-2-(4-Iodo-2,5-dimethoxyphenyl)-jV-(2- Lc methoxybcnzyl)ethanaminc (25I-NBOMe),(251-NBOMe), 2-(Methylamino)-1-phenylpentan-2-(Methylamino)-l-phenylpentan-l-one 1-one (pentedrone), 3-Fluoro-N-methylcathinone3-Fluoro-Ar-methylcathinone (3(3-FMC),-FMC), 4-Fluoro-N-methylcathinone (4(4-FMC),-FMC), 4- 2 Vol. I Page 840 L Anilino-jV-phenethyl-4-piperidineAnilino-N-phenethyl-4-piperidine (ANPP),(ANPP),4-Methyl-vV-ethylcathinone 4-Methyl-N-ethylcathinone (4-MEC),(4-MEC),4-Methyl-a- 4-Methyl-a- pyrrolidinopropiophenonepyrrolidinopropiophenone (4-MePPP),(4-MePPP), o/p/w-Pyrrolidinobutiophenonealpha-Pyrrondinobutiophenone (ct-PBP),(a-PBP),alpha- alpha- PyirolidinopentiophenonePyrrolidinopentiophenone (a-PVP),(a-PVP), amphetamineamphetamine (for(for sale),sale), codeinecodeine (for(for sale),sale), dihydrocodeine,dihydrocodeine, diphenoxylate,diphenoxylate, fentanyl,fentanyl, hydrocodonehydrocodone (for(for sale),sale), hydromorphone,hydromorphone, levorphanol,levorphanol, marihuana,marihuana, morphinemorphine (for(for conversion),conversion), jV-(I-Amino-3,3-dimethyl-l-oxobutan-2-yl)-l-pentyl-l//-indazole-3-N-(l-Amino-3,3-dimethyl-l-oxobutan-2-y1)-1-penty1-1Thindazole-3- carboxamidecarboxamide (ADB-PINACA),(ADB-PfNACA), N-(N-(11 --AminoAmino-3-methyl--3-methyl-I1 - -oxobutan-2-y1)-1-(4-fluorobenzy0-1H-oxobutan-2-y1)- 1 -(4-fluorobenzyl)- 1 H- indazole-3-carboxamideindazole-3-carboxamide (AB-FUBINACA),(AB-FUBINACA), naphthylpyrovaleronenaphthylpyrovalerone (naphyrone),(naphyrone), oripavine,oripavine, oxycodonepxycodone (for(for conversion),conversion), oxymorphoneoxymorphone (for(for conversion),conversion), oxymorphoneoxymorphone (for(for sale),sale), Quinolin-Quinolin- 8-yl8-y1 l-(5-fluoropentyl)-l/f-indole-3-carboxylate1-(5-fluoropentyl)-1H-indole-3-carboxylate (5'-Flouro-PB-22),(5-Flouro-PB-22), andand Quinolin-8-ylQuinolin-8-yl 1-pentyl-1-penty1- l//-indole-3-carboxylate1H-indole-3-carboxylate (PB-22)(PB-22) werewere insufficientinsufficient toto provideprovide forfor thethe estimatedestimated medical,medical, scientific, research,research, and industrialindustrial needsneeds of thethe UnitedUnited States, exportexport requirements,requirements, and thethe LL establishment and maintenance of reservereserve stocks. DeterminationDetermination ofof 20152015 AggregateAggregate ProductionProduction QuotasQuotas andand AssessmentAssessment ofof AnnualAnnual NeedsNeeds InIn determiningdetermining thethe 2020151 5 aggregate production quotas and assessment of annual needs, thethe DEA has taken into consideration the above comments along with the factors set forth at 21 CFR 1303.11 and 21 CFR 1315.11, in accordance with 21 U.S.C. 826(a), and other relevant factors, includingincluding thethe consideration of 20201414 manufacturing quotas, current 2014 sales and inventories,inventories, 2015 export requirements, industrial use, additional applications for quotas, as well as information'information on research and product development requirements. Based on this information, the DEA has determined that adjustments to the proposed aggregate production quotas and assessment of annual needs for alfentanil, cocaine, codeine-N-oxide,codeine-N-oxide, codeine (for sale), dihydrocodeine, fentanyl, hydromorphone, icvorphanol,levorphanol, marihuana, oripavine, oxymorphone Lc (for conversion), and ephedrine (for sale) are warranted. This notice reflects thosethose. adjustments. 3 Vol. I Page 841841 Regarding 1-0I-(I,3-Benzodioxol-5-yl)-2-(methyiamino)butan-l-one ,3-13enzodioxo1-5-y1)-2-(methylamino)butan-l-one (butylone), 1-(1,3-I -(1,3- L.L Benzodioxo1-5-y1)-2-(methylamino)pentan-l-oneBen2odioxol-5-yl)-2-(methylamino)pentan-I-one (pentylone), 2-(4-Bromo-2,5- dimethoxypheny1)-N-(2-methoxybenzypethanaminedimethoxyphcnyl)-/V-(2-methoxybenzyl)ethanamine (25B-NBOMe), 2-(4-Chloro-2,5- dimethoxypheny1)-N-(2-methoxybenzyBethanaminedimethoxyphenyl)-//-(2-methoxybenzyl)ethanamine (25C-NBOMe), 2-(4-lodo-2,5-2-(4-Iodo-2,5- dimethoxypheny1)-N-(2-methoxybenzyBethanaminedimethoxyphenyl)-A^-(2-methoxybenzyl)ethanamine (251-NBOMe), 2-(Methylamino)-1-2-(Methylamino)-l- phenylpentan-l-onephenylperitan-l-one (pentedrone),(pentedrone), 3-Fluoro-N-methylcathinone3 -Fluoro-iV-methylcathinone (3(3-FMC),-FMC), 4-Fluoro-N-4-Fluoro-jV- methylcathinone (4(4-FMC),-FMC), 4-Anilino-N-phenethy1-4-piperidine4-Anilino-ALphenethyl-4-piperidine (ANPP), 4-Methyl-N-4-Methyl-iV- ethylcathinone (4-MEC), 4-Methyl-a-pyrrolidinopropiophenone (4-MePPP), alpha- Pyrrolidinobutiophenone (a-PBP), alpha-Pyrrolidinopentiophenonea/p/w-Pyrrolidinopentiophcnone (a-PVP), amphetamine (for sale), dihydrocodeine, fentanyl, hydromorphone, levorphanol, marihuana, N-(1-Amino-3,3-iV-(l-Amino-3,3- dimethyl-l-oxobutan-2-y1)-1-penty1-1H-indazole-3-carboxamidedimethyl- 1 -oxobutan-2-yl)- 1 -pentyl-l//-indazole-3-carboxamide (ADB-PINACA),(ADB-PINACA), NN-(-(11-Amino-Amino-- -oxobutan-2-y1)-1-(4-fluorobenzy1)-11/-indazole-3-carboxamide (AB-FUBINACA),(AB-FUBINACA), Lc 33-methyl--methyl- 1 -oxobutan-2-yl)- 1 -(4-fluorobenzyl)- 1 //-indazole-3-carboxamide naphthylpyrovalerone (naphyrone), oxycodone (for conversion), oxymorphone (for sale), Quinolin-8-y1Quinolin-8-yl 1-(5-fluoropenty1)-111-indole-3-carboxylatel-(5-fluoropentyl)-l//-indole-3-carboxylate (5-Flouro-PB-22), and Quinolin-8-yl 1-penty1-1H-indole-3-carboxylatel-pentyl-l//-indole-3-carbo.xylate (PB-22), the DEA has determined that the proposed aggregate production quotas are sufficient to provide for the 2015 estimated medical, scientific, research, and industrial needs of the United States, export requirements, and the establishment and maintenance of reserve stocks. This notice finalizes these aggregate production quotas at the same amounts as proposed. As described in the previously published notice proposing the 2015 aggregate production quotas and assessment of annual needs, the DEA has specifically considered that inventory allowances granted to individual manufacturers may not always result in the availability of pursuant to 21 U.S.C. 826(a), as CL sufficient quantities to maintain an adequate reserve stock pursuant to 21 U.S.C. 826(a), as intended. See 21 CFR 1303.24.1303.24. This would be concerning if a natural disaster or other 4 Vol. I Page 842 unforeseenunforeseen eventevent resulted in substantial disruption to the amount of controlled substances L resulted in substantial disruption to the amount of controlled substances availableavailable toto provideprovide forfor legitimatelegitimate publicpublic need.need. AsAs such,such, thethe DEADEA hashas includedincluded inin allall proposedproposed revisedrevised scheduleschedule IIII aggregateaggregate productionproduction quotas,quotas, andand certaincertain scheduleschedule II aggregateaggregate productionproduction quotas,quotas, anan additionaladditional 25%25% ofof thethe estimatedestimated medical,medical, scientific,scientific, andand researchresearch needsneeds asas partpart ofof thethe amountamount necessarynecessary toto ensureensure thethe establishmentestablishment andand maintenancemaintenance ofof reservereserve stocks.stocks. TheThe resultingresulting • • revisedrevised establishedestablished aggregateaggregate productionproduction quotaquota willwill reflectreflect thesethese includedincluded amounts.amounts. ThisThis actionaction willwill notnot affectaffect thethe abilityability ofof manufacturersmanufacturers toto maintainmaintain inventoryinventory allowancesallowances asas specifiedspecified byby regulation.regulation. TheThe DEADEA expectsexpects thatthat maintainingmaintaining thisthis reservereserve inin certaincertain establishedestablished aggregateaggregate productionproduction quotasquotas willwill mitigatemitigate adverseadverse publicpublic effectseffects ifif anan unforeseenunforeseen eventevent resultsresults inin thethe substantialsubstantial disruptiondisruption toto thethe amountamount ofof controlledcontrolled substancessubstances availableavailable toto provideprovide forfor legitimatelegitimate publicpublic need,need, asas determineddetermined byby thethe DEA.DEA. TheThe DEADEA doesdoes notnot anticipateanticipate utilizingutilizing thethe reservereserve inin thethe LL absenceabsence ofof thesethese circumstances.circumstances. InIn accordanceaccordance withwith 2121 USCUSC 826,826, 212 1 CFRCFR 1303.11,1 303. 1 1 , andand 2121 CFRCFR 1315.11,13 1 5. 1 1, thethe DeputyDeputy AdministratorAdministrator herebyhereby establishesestablishes thethe 20152015 aggregateaggregate productionproduction quotasquotas forfor thethe followingfollowing scheduleschedule II andand IIII controlledcontrolled substancessubstances andand thethe 2015201 5 assessmentassessment ofof annualannual needsneeds forfor thethe listlist II chemicalschemicals ephedrine,ephedrine, pseudoephedrine,pseudoephedrine, andand phenylpropanolamine,phenylpropanolamine, expressed.expressed inin gramsgrams ofof anhydrousanhydrous acidacid oror base,base, asas follows:follows: - EstablishedEstablished BasicBasic ClassClass 20152015 QuotasQuotas (g)(g) ScheduleSchedule II (1-Penty1-1H-indo1-3-yi)(2,2,3,3-tetramethylcyclopropyl)methanone(l-Pentyl-l//-indol-3-yl)(2,2,3,3-tetramethy1cyclopropyl)methanone 15IS (UR-I(UR-144) 44) • _ [1-(5-Fluoro-pentyl)-1H-indol-3-y1](2,2,3,3-[l-(5-Fluoro-pentyl)-l/f-indol-3-yl](2,2,3,3- 1515 tetramethylcyclopropyl)methanonetetramcthylcyclopropyl)methanone (Xrsi(XLR1 1)1) 1-(1,3-Benzodioxo1-5-y1)-2-(methylamino)butan-l-onel-(l,3-Benzodioxol-5-yl)-2-(methylamino)butan-l-one (butylone)(butylone) 1515 1-0,3-Benzodioxo1-5-y1)-2-(methylamino)pentan-l-onel-(l,3-Benzodioxol-5-yl)-2-(methylamino)pentan-l-one (pentylone)(pentylone) 1515 L 1-(1-Phenylcyclohexyl)pyrrolidinel-(l-Phenylcyclohexyl)pyrrolidine 1010 1-(5-Eluoropentyl)-3-(1-naphthoyOindole1 -(5-FJuoropentyl)-3 -( l-naphthoyI)indole (AM2201)(AM220 1 ) 45 5 Vol. I Page 843843 l-(5-Fluoropentyl)-3-(2-iodobenzoyl)indole1-(5-Fluoropentyl)-3-(2-icdobenzoyl)indole (AM694)(A1\4694) 4545 l-[l-(2-Thienyl)cyclohexyl]piperidine1-11-(2-Thienyl)cyclohexylThiperidine 15 l-[2-(4-Morpholinyl)ethyl]-3-(l-naphthoyl)indole142-(4-MorpholinyDethyl]-3-(1-naphthoyDindole (JWH-200)(JWH-200) 4545 l-Butyl-3-(L-naphthoyl)indole1-Butyl-3-(1-naphthoyDindole (JWH-073)(JWH-073) 4545 • !-CycIohexylethyl-3-(2-methoxyphenylacetyi)indoIe1-Cyclohexy1ethyl-3-(2-methoxyphenylacetyl)indole (SR-1(SR-188 andand 4545 RCS-8)RCS-8) \1-Mexy1-3-(1-naphthoyDindole-Hexyl-3-(l-naphthoyl)indole (JWH-0(JWM-019)1 9) 4545 l-Methyl-4-phenyl-4-propionoxypiperidine1-Methyl-4-phenyl-4-propionoxypiperidine ' 22 l-Pentyl-3-(l-naphthoyl)indole1-Penty1-3-(1-naphthoyDindole (JWH-Q1(JWH-0188 andand AM678)AM678) . 4545 11-Penty1-3-(2-chlorophenylacety0indole-Pentyl-3-(2-chlorophenylacetyI)indole (JWH-203)(JWH-203) 4545 11-Penty1-3-(2-methoxyphenylacetyl)indole-Pentyl-3 -(2-methoxyphenylacetyl)indole (JWH-25Q)(JWH-250) 4545 1-Penty1-3-(4-chloro-l-naphthoyDindole1 -Pentyl-3-(4-chloro-l-naphthoyl)indole (JWH-398) 4545 1I-Penty1-3-(4-methyl-1-naphthoyDindole-Pentyl-3-(4-methyl-l-naphthoyI)indole (JWH-122)(JWH-122) 4545 l-Pentyl-3-[(4-methoxy)-benzoyl]I-Pentyl-3-[(4-methoxy)-benzoyl]indoleindole (SR-1(SR-19,9, RCS-4)RCS-4) 4545 l-Pentyl-3-[l-(4-mcthoxynaphthoyl)]indole1-Penty1-3-[1-(4-methoxynaphthoy1)] indole (JWH-081)(JWII-08 I) 4545 2-(2,5-Dimethoxy-4-«-propylphenyl)ethanamine2-(2,5-Dimethoxy-4-n-propylphenyDethanamine (2C-P)(2C-P) 30 2-(22-(2,5-Dimethoxy-4-ethylphenyl)ethanamine, 5 -Dimethoxy-4-ethylphenyl)ethanamine (2C-E)(2C-E) 30 2-(2,5-Dimethoxy-4-methylphenyl)ethanamine2-(2,5-Dimethoxy-4-methylphenyl)cthanamine (2C-D)(2C-D) 30 2-(2,5-Dimethoxy-4-nitro-phenyl)ethanamine2-(2,5-Dimethoxy-4-nitro-phenyDethanamine (2C-N)(2C-N) 30 C 2-(2,5-DimethoxyphenyI)ethanamine2-(2,5-Dimethoxyphenyl)ethanamine (2C-H)(2C-11) 30 2-(4-Bromo-2,5-dimethoxyphenyl)-jV-(2-methoxybenzyl)ethanamine2-(4-Bromo-2,5-dimethoxyphenyl)-N-(2-methoxybenzyl)ethanamine 15 (25B-NBOMe; 2C-B-NBOMe; 25B; Cimbi-36) 2-(4-Chloro-2,5-dimcthoxyphenyl)ethanamme2(4-Chloro-2,5-dimethoxyphenyDethanamIne (2C-C)(2C-C) 30 2-(4-Chloro-2,5-dimethoxyphenyl)-Ar-(2-methoxybenzyl)ethanamine2-(4-Chloro-2,5-dimethoxypheny1)-N-(2-methoxybenzyDethanamine 15 (25C-NBOMe; 2C-C-NBOMe; 25C; Cimbi-82) 2-(4-lodo-2,5-dimethoxyphenyl)ethanamine2-(4-Iodo-2a5-dimethoxypheriyl)ethanamine (2C(2C-I)-I) 30 2-(4-Iodo-2,5-dimethoxyphenyI)-7/-(2-methoxybenzyI)ethan2-(4-lodo-2,5-dimethoxyphenyl)-N-(2-methoxybenzyl)ethanamineamine 15 (251-NBOMe; 2C-I-NBOMe; 251; Cimbi-5) 2-(Methylamino)-l-phenylpentan-l-one2-(Methylamino)-1-phenylpentan-I-one (pentedrone) 15 2,5-Dimethoxy-4-ethylamphetamine (DOET)(POET) 25 2,5-Dimethoxy-4-n-propylthiophenethylamine2a5-Dimethoxy-4-/i-propylthiophenethylamine 25 2,5-Dimethoxyamphetamine 25 2[4-(Ethylthio)-2,5-dimethoxyphenyllethanamine2-[4-(£thylthio)-2,5-dimethoxyphenyl]ethana[nine (2C(2C-T-2)-T-2) 30 ' 2[4-(Isopropylthio)-2,5-dimethexyphenyl]ethanamine2-[4-(Isopropylthio)-2,5-dimethoxyphenyl]ethanamine (2C(2C-T-4)-T-4) 30 3,4,5-Trimethoxyamphetamine 25 3,4-Methylenedioxyamphetamine (MDA) 55 3,4-Methylenedioxymethamphetamine (MDMA) 50 3,4-Methylenedioxy-N-ethylamphetamine3 ,4-Methylenedioxy-N-ethylamphetamine (MIJEA)(MDEA) 40 3,4-Methylenedioxy-N-methyleathinone3,4-Methylenedioxy-Ar--methylcathinone (methylone)(methylone) 50 3,4-Methylenedioxypyrovalerone3 ,4-Methylenedioxypyrovalerone (MDPV)(MDPV) 3535 6 Vol. I Page 844844 3-Fluoro-N-methylcathinone3-Fiiioro-vV-methylcathinone (3(3-FMC)-FMC) 1515 L 3-Methylfentanyl ' 2 • 3-Methylthiofentanyl3-MethyIthiofentanyl 2 4-Bromo-2,5-dimethoxyamphetaminc (DOB) 25 4-Bromo-2,5-dimethoxyphenethylamine4-Bromo-2,5-dimethoxyphenethylamihe (2(2-CB)-CB) 25 4-Fluoro-N-methyldathinone4-Fluoro-Ar-methylcathinone (4(4-FMC)-FMC) 1155 4-Methoxyamphetamihe4-Methoxyamphetamibe 100100 4-Methyl-2,5-dimethoxyamphetamine (DOM) 25 4-Methylaminorex 25 4-Methyl-N-ethylcathinone4-Methyl-jV-ethyIcathinonc (4-MEC) • 1515 4-Methyl-N-methylcathinone (mephedrone) 45 4-Methyl-a-pyrrolidinopropiophenone4-MethyI-a-pyrrolidinopropiophenone (4-MePPP) 1515 5-05-(l,l-Dimethylheptyl)-2-[(lfl,3S)-3-hydroxycyclohexyl]-pheriol ,1 -Dimethylhepty1)-2-[(1R,3S)-3-hydroxycyclohexyl]-phenol 68 ,1-Dimethyl o ctyI)-2-[(1R,38)-3-hydroxycyclohexyl]1 /?,3 7 Vol. I Page 845 BufotenineBufotenine 33 L CathinoneCathinone 7070 CodeineCodeine mettoylbromidemethylbromide 55 Codeine-A^-oxideCodeine-N-oxide 305305 DesomorphineDesomorphine 55 DiethyltryptamineDiethyltryptamine 2525 DifenoxinDifenoxin 5050 DihydromorphineDihydromorphine 3,990,0003,990,000 DimethyltryptamineDimethyltryptamine 3535 DipipanoneDipipanone 55 FenethyllineFenethylline 55 guwmo-Hydroxybutyricgamma-Hydroxybutyric acid 70,250,00070,250,000 Heroin 25 HydromorphinolHydromorphinol 22 HydroxypethidineHydroxypethidine 22 Ibogaine 5 Lysergic acid diethylamide (LSD) 35 Marihuana 125,000 Mescaline 25 Methaqualone 10 Methcathinone 25 Methyldesorphine 5 Methyldihydromorphine 2 Morphine methylbromide 5 Morphine methylsulfonate 5 Morphine-N-oxideMorphine-N-oxide 350 N-(N-(1-AdamantyI)-1-pentyl-IH-indazole-3-carboxarnide1 -Adamantyl)- 1 -pentyL- 1 /7-indazo le-3 - carboxamide (AKB48) 15 //-(l-Amino-3,3-dimethyl-l-oxobutan-2-yl)-l-pentyl-l//-indazole-N-(1-Amino-3,3-dimethy1-1-oxobutan-2-34)-1-penty1-1H-indazole- 15 3-carboxamide (ADB-PINACA) ;V-(l-Amino-3-methyl-l-oxobutan-2-yl)-l-(4-fluorobenzyl)-l//-N-(1-Amino-3-methyl-l-oxobutan-2-y1)-1-(4-fluorobenzy1)-1H- 1515 indazole-3-carboxamide (AB-FUB1NACA)(AB-FUBINACA) N,N-Dimethylamphetamine^/-Dimethyl amphetamine 25 Naphthylpyrovalerone (naphyrone) 1515 N-Benzylpiperazine 25 N-Ethyl-lN-Ethyl-l-phenylcyclohexylaminerphenylcyclohexylamine 5 N-EthylamphetamincAr-Ethylamphetaminc 24 N-Hydroxy-3,4-methylenedioxyamphetamineiV-Hydroxy-3,4-methylenedioxyamphctamine 24 c Noracymethadol 2 Norlevorphanol 52 88 Vol. I Page 846846 Normethadone 2 c Normorphine 1818 Phenomorphan . 2 Psilocybin 30 . Psilocyn 30 Quinolin-8-y1Quinolin-8-yl 1-(5-fluoropentyl)-IH-indole-3-carboxylate1 -(5 -fluoropenty1)- 1 //-indole-3 -carboxylate (5-fluoro- 1515 P3-22;PB-22; 5F-PB-22) Quinolin-8-yll-perity1-1H-indole-3-carboxylateQuinolin-8-yl l-pentyl-l/j-indole-3-carboxylate (PB-22; QUPIC) 1515 Tetrahydrocannabinols 497,500 . Thiofentanyl 2 Tilidine 1010 Trimeperidine 2 Schedule II 11 -P-Phenylcyclohexylamine henylcyclohexylamine 5 1-Piperidinocyclohexanecarbonitrile1-Piperidinocyclohexanecarbonitrile 5 4-Anilino-N-phenethyl-4-piperidine4-Anilino-7/-phenethyl-4-piperidine (ANPP) 2;687,5002i687,500 Alfentanil 17,75017,750 Alphaprodine 3 .< AmobarhitalAmobarbital 25,125 k Amphetamine (for conversion) 21,875,000 Amphetamine (for sale) 37,500,000 Carfentanil 1919 Cocaine 275,000 Codeine (for conversion) 50,000,000 Codeine (for sale) 49,500,000 Dextropropoxyphene 1919 Dihydrocodeine 226,375 Diphenoxylate 1,337,5001,337,500 Ecgonine 174,375174,375 Ethylmorphine 3 Fentanyl 2,150,000 Glutethimidc 3 Hydrocodone (for conversion) 137,500137,500 Hydrocodone (for sale) 99,625,000 Hydromorphone 7,000,000 Isomethadone 5 _ Levo-alphacetylmethadol (LAAM) 4 Levomethorphan 5 Levorphanol 7,125 Lisdexamfetamine 29,750,000 c Meperidine 6,250,000 Meperidine IntermediateIntermediate-A-A 6 Meperidine IntermediateIntermediate-B-B 1111 9 Vol. I Page 847 MeperidineMe eridine Intermediate-CIntermediate-C 6 L MetazocineMetazocine 19 MethadoneMethadone (for(for sale)sale) 31,875,00031,875,000 MethadoneMethadone IntermediateIntermediate 34,375,00034,375,000 i MethamphetamineMethamphetamine 2,061,3752,061,375 [1,250,000[1,250,000 gramsgrams ofof /evo-desoxyephedrinelevo-desoxyephedrine forfor useuse inin aa non-controlled,non-controlled nonnon- prescriptionprescription product;product; 750,000750,000 gramsgrams forfor methamphetaminemethamphetamine mostlymostly for.for conversionconversion toto aa scheduleschedule IIIIII product;product; andand 61,37561,375 gramsgrams for.for methamphetaminemethamphetamine (for(for sale)]sale)] Methylphenidate 83,750,000 Morphine (for(for conversion)conversion) 91,250,00091,250,000 MorphineMorphine (for(for sale) 62,500,00062,500,000 NabiloneNabilone 18,750 NoroxymorphoneNoroxymorphone (for(for conversion)conversion) 17,500,000 NoroxymorphoneNoroxymorphone (for sale) 1,475,000 Opium (powder) 112,500 Opium (tincture) 687,500 Oripavine 35,000,000 Oxycodone (for conversion) 8,350,000 Oxycodone (for sale) 137,500,000 Oxymorphone (for conversion) 29,000,000 Oxymorphone (for sale) 7,750,000 Pentobarbital 35,000,000 PhenazocinePhenazocine 6 Phencyclidine 19 Phenmetrazine 3 Phenylacetone 9,375,000 Racemethorphan 3 Remifentanil 3,750 Secobarbital 215,003 Sufentanil 6,255 Tapentadol 12,500,000 Thebaine 125,000,000 List I Chemicals Ephedrine (for conversion) 1,000,0001,000,000 Ephedrine (for(for sale) 4,000,000 Phenylpropanolamine (for(for conversion) 44,800,000 Phenylpropanolamine (for sale) 8,500,000 Pseudoephedrine (for conversion) 7,000 Pseudoephedrine (for sale) 224,500,000 L The Deputy Administrator alsoalso establishes aggregateaggregate production quotas forfor allall other scheduleschedule II andand IIII controlledcontrolled substancessubstances includedincluded inin 2121 CFRCFR 1308.111308.1 L andand 1308.121308.12 atat zero.zero. Pursuant toto 2121 CFRCFR 1303.131303.13 andand 2121 CFRCFR 1315.13,1315.13, upon considerationconsideration ofof thethe relevantrelevant factors,factors, thethe DeputyDeputy 1010 Vol. I Page 848848 AdministratorAdministrator maymay adjustadjust thethe2015 2015 aggregateaggregateproduction production quotasquotas andand assessmentassessment ofofannual annual needsneeds L asas needed.needed. - Dated:Dated: ThomasThomas M.M. Harrigan,Harrigan, DeputyDeputy AdministratorAdministrator L L 1111 Vol. I Page 849849 OC:OC: LL OD:OD: OD/D:OD/D: ODX:ODX: ODXS:ODXS: ODW:ODW: ODQ:ODQ: ODQQDQp>X6) MO) 08-15-14]08-15-14 WebeimsWebcims ## ODEQODEQ 141 4 -- (DFN#:(DFN#: 680-03680-03 DrugDrug controlcontrol filesfiles -- ManufacturingManufacturing andand ProcurementProcurement quotas)quotas) c LL 1212 Vol. I Page 850850 5321653216 FederalFederal Register/Vol.Register/Vol. 79,79, No.No. 173173/Monday, /Monday, SeptemberSeptember 8,8, 2014/Notices2014,/Notices equipmentequipment manufacturers,manufacturers, separationseparation ofof thethe UnitedUnited States.States. ControlledControlled pseudoephedrine,pseudoephedrine, andand L systemsystem designers,designers, andand endend users,users, substancessubstances havehave thethe potentialpotential forfor abuseabuse phenylpphenylpropanolamine. ropanoiamine. CommentersCommenters andand dependencedependence andand areare controlledcontrolled toto statedstated thatthat thethe proposedproposed aggregateaggregate PatriciaPatricia A.A. Brink,Brink, protectprotect thethe publicpublic healthhealth andand safety.safety productionproduction quotasquotas forfor 141,3-l-(l,3- Di:yensDirector-ofof CivilCivil EnforcementEnforcement, AntitrustAn titrust SectionSection 306306 ofof thethe ControlledControlled Benzodioxo1-5-y1)-2-(methylamino)Benzodioxol-S*yl)-2-(metliylamino) Division.Division. SubstancesSubstances ActAct (CSA)(CSA) (21.(21 U.S.C.U.S.C. 826)826) buten-l-onebutan-i-one (butylone),141,3-(butylone), 1-(1,3- Itm[FR DcDoc.c. 2014412862014-21286 FiledFiled 0-5-14:9—5-14; 5:458:45 emlami requiresrequires thethe AttorneyAttorney GeneralGeneral toto Benzodioxol-5-y1)-2-(methylamino)Benzodioxol-5-yl)-2-(methy!amino) MOOGBILUHO CODECODE PP establishestablish aggregateaggregate productionproduction quotasqiuotas pentan-1-onepentan-l-one (pentylone),(pentylone), 2-(4-Bromo.2-(4-Bromo- forfor eacheach basicbasic classclass ofof controlledcontrolled 2.5-dimethoxypheny1)-N42-2,5-dimethoxyphenyl)-N-(2- substancesubstance listedlisted inin schedulesschedules II andand IIII methexybenzyllethanaminemethoxyhenzyOethanaoUne (MB-(25B- DEPARTMENTDEPARTMENT OFOF JUSTICEJUSTICE andand forfor ephedrine,ephedrine, pseudoephedrine,pseudoephedrine, NBOMe),NBOMe), 244-Chloro-2,5-2-(4-Chloro-2,5- andand phonylpropanolamine.phenylpropanolamine. ThisThis dimethoxypheny1)-N-(2-dimethoxy phenyl) -iV-(2- DrugDrug EnforcementEnforcement AdministrationAdministration responsibilityresponsibility hashas beenbeen delegateddelegated toto thethe methoxyhenzyl)ethanaminemethoxyhenzyljethanamine (25C-(25C- [Docket(Docket No.No. DEA-3931DEA-393] AdministratorAdministrator ofof thethe DEADEA throughthrough 2828 NBOMe),NBOMe], 2-(4-lodo-2,5-2-(4-Iodo-2,5* CFRCFR 0.100(b).0.100(b). TheThe Administrator,Administrator, inin dimethoxyphenyi)-N-(2-dimethoxyphenyl)-N-(2- EstablishedEstablished AggregateAggregate ProductionProduction turn,turn, hashas redelegatedredelogalad thisthis functionfunction toto thethe methoxybenzyllethanaminemethoxybenzyl)ethananune (251-(251- QuotasQuotas forfor ScheduleSchedule II andand IIII ControlledControlled DeputyDeputy Administrator,Administrator, pursuantpursuant toto 262B NBOMe),NBOMe), 2-(Methylamino)-1-2-(Methylamino)-l-" SubstancesSubstances andand Assessment otof CFRCFR pt.pt. 00 subpt.subpt. R.R, App.App. phenylpentan-l-onephenylpertfan-J-orte (pentadrone),(pentudrone), 33-- AnnualAnnual NeedsNeeds forfor thethe ListList I1 ChemicalsChemicals Fl uoro-N-methyl cathinene (3-FMC), 4- Background Fluoro-lV-methylcathinone (3-FMC), 4- Ephedrine,Ephedrine, PseudoephedrIne,Pseudoephedrine, andand Background Fluoro-N-methylcathinoneFluoro-iV-methylcathinone (4(4-FMC).-FMC), 4-4- PhenyipropanolaminePhenylpropanolamine forfor 20152015 TheThe 20152015 aggregateaggregate productionproduction quotasquotas Anilino-N-phenethyL-4-piperidineAnilino-Af-phenethyl-4-piperidine endend assessmentassessment ofof annualannual needsneeds AGENCY:AGENCY: DrugDrug EnforcementEnforcement (ANPP),(ANPP), 4-Methyl-N-ethylcathinone4-Methyl-A,-ethyleathinone (4-(4- representrepresent thosethose quantitiesquantities ofof scheduleschedule II AdministrationAdministration (DEA)(DEA), DepartmentDepartment ofof MEC).MEC). 4-Methyl-a-4-Metliyl-a- andand II11 controlledcontrolled substancessubstances andand thethe listlist justiceJustice (DO)).(DO)). pyrrolidinopropiophenonepyrrolidinopropiophenone (4,54ePP9).(4-MePPP). I1 chemicalschemicals ephedrine,ephedrine, alpha-Pyrrolidinobutiophenonea/pho-Pyrrolidinobutiophenonc (a-la- ACTION:ACTION: Notice.Notice. pseudoephedrine,pseudoephedrine, andand PRP),PBP), olpha-PyrrolidinopentiophenoneolpIio-Pyrrolidinopantiaphenone phenylpropanolamine SUMMARY:SUMMARY: ThisThis noticenotice establishesestablishes thethe ' 1 phenylpropanolamine tota behe (a-PVP),(a-I'VP), amphetamineamphetamine (for(for sale),sale), initialinitial 20152015 aggregateaggregate productionproduction quotasquotas manufacturedmanufactured inin thethe UnitedUnited StatesStates inin codeinecodeine (for(for sale),sale), dihydrocodeine,dihydrocodeine, , 20152015 toto provideprovide forfor the estimatedestimated forfor controlledcontrolled substancessubstances inin schedulesschedules I1 the diphenoxylate,diphenoxylate, fentanyl,fentanyl, hydrocodonehydrocodone medical, scientific,scientific, research,research, andand andand IIII ofof thethe ControlledControlled SubstancesSubstances ActAct medical, (for(for sale).sale), hydromorphone,hydromorphone, levorphanol.levorphanol. industrialindustrial needsneeds ofof thethe UnitedUnited States,States, (CSA)(CSA) andand thethe assessmentassessment ofof annualannual , marihuana,marihuana, morphinemorphine (for(for conversion),conversion), needsneeds forfor thethe listlist II chemicalschemicals ephedrine,ephedrine, lawfullaw^ exporte*Port requirements,requirements, andand thethe N-(1-Amino-3,3-dhnothyl-l-exobuten-2-N-(l-Amina-3.3-diuioUiyl-1-oxobulan-2- establishment pseudoephedrine,pseudoephedrine, andand establishment andand maintenancemaintenance ofot y1)-1-penty1-1Thindazole-3-carboxamideyl)-l-pentyl-lH-indazole-3-carboxamide reserve include phenylpropanolamine. reserve stocks.stocks. TheseThese quotasquotas include (ADB-PINACA),(ADB-PINACA), N-Ilamino-3-methyl-A'.;i-Amino-3-methyl- ' importsimports ofof ephedrine,ephedrine. pseudoephedrine,pseudoephedrine. 1-oxobutan-2-y1)-1-(4-fluorobanzyl)-1H-l-oxobutan-2-yl)-l-(4-fluocohanzyl)-lH- c DATES: Effective date:date: Effective andana phenylpropanolamine but dodo not indmole-3-carboxamideindazole-3-carboxamide (AB-(AB- SeptemberSeptembers, 8, 2014.2014. includeinclude importsimports ofof controlledcontrolled FUBINACA), naphthylpyroveleronenaphthylpyrovalerone FORFOR FURTHERFURTHER INFORMATIONINFORMATION CONTACT: substancessubstances forfor useuse inin industrialindustrial (naphyrone).(naphyrone), oripavine.oripavine. oxycodoneoxycodone (for(for ImeldaImelda Paredes.Paredos. ExecutiveExecutive Assistant,Assistant, processes.processes. conversion).conversion), oxymorphoneoxymorphone (for(for ➢rug OfficeOffice ofof DiversionDiversion Control,Control, Drug OnOn JulyJuly 2,2, 2014.2014, aa noticenotice titled,titled. conversion).conversion), oxymorphoneoxymorphone (for(for sale),sale), EnforcementEnforcement Administration,Administration, 87018701 "Proposed"Proposed AggregateAggregate ProductionProduction QuotasQuotas Quinolin-8-ylQuinolin-8-yl 1-(5-fluaropenty11-1H-l*(5-fluoropentyl)-lff- MorrissetteMorrissette Drive,Drive, Springfield,Springfield, VAVA forfor ScheduleSchedule II andand IIII ControlledControlled indole-3-carboxylateindole-3-carboxylate (5-Flouro-PB-22).(5-Plouro-PB-22), 22152, Telephone: (202)(202) 598-6612.598-6612, Substances andand Proposed Assessment of andand Quinolin-8-yl 1-penty1-11Mndole-3-l-pentyl-lH-indole-3- SUPPLEMENTARY INFORMATION:INFORMATION: Annual Needs forfor thethe List II Chemicals carboxylate (PB-22)(PB-22) were insufficientinsufficient toto Ephedrine,Ephodrine, Pseudoephedrine,Pseudoephedrine, andand provide for the estimated medical. LegalLegal AuthorityAuthority provide for the estimated medical. PhenylpropanulaminoPhenylpropanolamine forfor 2015"2015" waswas scientific,scientific, research,research, andand industrialindustrial needsneeds TheThe DrugDrug EnforcementEnforcement published inin thethe FederalFederal Register.Register. 707Q FRFR ofof thethe UnitedUnited States,States, exportexport AdministrationAdministration (DEA)(DEA) implementsimplements andand 37772.37772. ThisThis noticenotice proposed thethe 20152015 requirements,requirements, endand thethe establishmentestablishment enforcesenforces titlestitles IIII andand IBIII ofof thethe aggregateaggregate production quotasquotas forfor eacheach andand maintenance ofof reservereserve stocks.stocks. ComprehensiveComprehensive Drug Abuse Prevention basic classclass ofof controlledcontrolled substancesubstance listedlisted Determination of 2015 Aggregate and Control Act of 1970,1970, as amended. inin schedulesschedules I and II andand the 2015 Production QuotasQuotas andand Assessment ofof Titles IIII andand IIIIII areare referredreferred toto asas thethe assessmentassessment ofof annualannual needs forfor thethe listlist Annual Needs "Controlled"Controlled SubstancesSubstances Act" andand thethe II chemicalschemicals ephedrine,ephedrine, "Controlled"Controlled SubstancesSubstances ImportImport andand pseudoephedrine,pseudoephedrine. andand InIn determining thethe 20152015 aggregateaggregate Export Act."Act," respectively,respectively, andand areare phonylpropanolamine.phenylpropanolamine. All interestedinterested production quotas andand assessmentassessment of collectively referredreferred toto asas thethe persons were invitedinvited toto commentcomment onon oror annualannual needs, thethe DEA has takentaken intoinlo "Controlled"Controlled Substances Act" or thethe object toto thethe proposed aggregateaggregate consideration thethe aboveabove commentscomments "CSA""CSA" forfor thethe purpose ofof thisthis action.action. 2121 production quotasquotas andand thethe proposed aalong long withwith thethe factorsfactors setset forthforth atat 2121 U.S.C. 801-971.801-971. The DEA publishes thethe assessmentassessment of annual needs on or before CFR 1303.111303.11 andand 21 CFR.1315.11,CFR 1315.11, inin implementingimplementing regulations forfor thesethese August 1,1, 2014. accordance with 21 U.S.C. 826826 (a),(a), and statutesstatutes inin titletitle 21 of thethe Code of Federal other relevant factors,factors, includingincluding thethe Comments Received Regulations (CFR),(CFR), parts 13001300 toto 1321.1321. consideration of 2014 manufacturing The CSA and itsits implementingimplementing Five comments were received fromfrom quotas, current 2014 salessales and regulations are designed toto prevent, DEA-registered manufacturers within inventories.inventories. 2015 export requirements.requirements, detect,detect, andand eliminateeliminate thethe diversiondiversion ofof thethe published commentcomment period.period, offeringoffering industrialindustrial use, additionaladditional applicationsapplications controlledcontrolled substancessubstances andand listedlisted commentscomments onon aa totaltotal ofof 3232 scheduleschedule I1 forfor quotas,quotas, asas wellwell asas informationinformation onon chemicals Intointo the illicit market while and II controlled substances.substances. None of research and product development L providing for the legitimate medical, the respondents commented on the list requirements. Based on this scientific, research, and industrial needs I chemicals ephedrine. information, the DEA has determined Vol. I Page 851 FederalFederal Register/Register/Vol.Vol. 79,79, No.No. 173/Monday,173 /Monday, SeptemberSeptember 8,8, 2014/Notices2014/ Notices 5321753217 thatthatadjustments adjustmentsto tothe theproposed proposed catboxamidacarboxamide (ADB-PINACA),(ADB-PINACA),N-{ N-(11-- publicpublicneed. need.As Assuch, such, thetheDEA DEAhas has L aggregateaggregateproduction productionquotas quotasand and Amino-3-methyl-l-axobutan*2-yl)-l-(4-Am ino-3-methyl-l-oxobutan-2-yll-1-(4- includedincludedin in allallestablished establishedschedule scheduleII II assessmentassessment ofofannua) annualneeds needsfor for fluorobenzyl)-ltf-indazole-3-fluorobenzy11-1H-indazole-3- aggregateaggregateproduction production quotas,quotas,and and certaincertain alfentanil,alfentanil,cocaine, cocaine,codeine-N-oxide, codeine-N-oxide. carhoxamidecarhoxamide(AB-FUBINACA). (AB-FUBINACA), scheduleschedule1 Iaggregate aggregateproduction productionquotas, quotas, codeinecodeine(for (forsale), sale),dihydrocodeine, dihydrocodeine, naphthylpyrovaleronenaphthylpyrovalerone(naphycone), (naphyrone). ananadditional additional 25%25%of ofthe theestimated estimated fentanyl,fentanyl,hydromorphone, hydramorphone;levorphanol, levorphenol, oxycodoneoxyeadone(for (forconversion), conversion), medical,medical,scientific, scientific,and andresearch researchneeds needs marihuana,marihuana,oripavine. oripavine.oxymorphone oxymorphone oxymorphoneoxymorphone (for(forsale). sale).Quinolin-8-yl Quinolin-8-yl 1- asaspart partof ofthe theamount amountnecessary necessaryto to (for(forconversion), conversion),and and ephedrineephedrine (for(for (5-fkioropentyl)-lH»indole-3-(5-fluoropenty 0-111-Indole-3- ensureensure thethe establishmentestablishmentand and sale]sale) arearewarranted. warranted.This Thisnotice notice reflectsreflects carboxylatecarboxylate (5-Flouro-PB-22),(5-Flouro-P13-22), andand maintenancemaintenance ofof reservereserve stocks.stocks.The The thosethose adjustments.adjustments. Quinolin-8-yiQuinolin-8-y11.penty1-1H-indole-3-l-pentyl-lH-indcle-3- resultingresulting establishedestablishedaggregate aggregate RegardingRegarding l-(l,3-Ben2odiaxol-5-yl)-2-1-(1.3-BenzodioxoL-5-y1)-2- carboxylatecarboxylate (PB-22),(1313-22), thethe DEADEAhas has productionproductionquota quota willwill reflectreflect thesethese (methylaroino)butan-l-one(methylamino)butan-1-one (butylone),(butylone), determineddetermined thatthat thethe proposedproposed aggregateaggregate includedincludedamounts. amounts, ThisThis actionactionwill will notnot 1-(l,3-Benzodioxol-5-yl)-2-1-(1,3-13enzodioxol-5-y1)-2- productionproduction quotasquotes arearesufficient sufficient toto affectaffect thethe abilityabilityof of manufacturersmanufacturers toto (methylamino)pentah-l-one.(pentylone),(methylamino)pentab-1-one,(pentylone). provideprovidefor for thethe2015 2015estimated estimated medical,medical. maintainmaintain inventoryinventoryallowances allowancesas as 2-(4-Bromo-2,5-dimethoxyphenyl)-N-(2-2-(4-Bromo-2,5-dimethoxyphenyI)-N-(2- scientific,scientific.research, research,and and industrialindustrial needsneeds specifiedspecifiedby byregulation. regulation.The The DEADEA methoxybenzyl)ethanaminemethoxybenzgethanamine (25B-(2513- ofof thethe UnitedUnitedStates, Stales,export export expectsexpectsthat thatmaintaining maintainingthis thisreserve reserve inin NBOMe),11130Me),2-(4-Chloro-2,5- 244-Chloro.2,S. requirements,requirements,and and thetheestablishment establishment certaincertain establishedestablished aggregateaggregate productionproduction dimethoxyphonyI)-iV-(2-dimethoxyphonyll-N-(2- andandmaintenance maintenance ofofreserve reserve stocks.stocks. ThisThis quotasquotaswill will mitigatemitigate adverseadverse publicpublic methoxybenzyl]ethanaminemetboxybenzyl)ethanamine (25C-(25C- noticenotice finalizesfinalizes thesethese aggregateaggregate effectsaffects ififan an unforeseenunforeseen eventevent resultsresults inin NBOMe),NBOMe), 2-(4-Iodo-2,5-2-(4-lodo.2,5- productionproduction quotasquotas atat thethe samesame amountsamounts thethe substantialsubstantial disruptiondisruption toto thethe amountamount dimethoxyphenyl)-N-(2-dimethoxyphenyll-N-(2- asas proposed,proposed, ofof controlledcontrolled substancessubstances availableavailable toto methoxybenzyl)ethanaminomethoxybenzyllethanamine (251-(251- AsAs describeddescribed inin thethe previouslypreviously provideprovide forfor legitimatelegitimate publicpublic need,need, asas NBOMe),NBOMe), 2-(Methylamino)-l-2-(Mathylamino)-1- publishedpublished noticenotice proposingproposing thethe 20152015 determineddetermined byby thethe DEA.DEA. TheThe DEADEA doesdoes phenylpentan-l-onephenylpentan-1-one (pentedrone),(pentedrone), 3-3- aggregateaggregateproduction production quotasquotasand end notnot anticipateanticipate utilizingutilizingthe the reservereserve inin Fluoro-N-methylcathinoneFluaro.N-methylcathinone (3-FMC),(3-FMC), 4-4- assessmentassessment ofofannual annual needs,needs, thethe DEADEA thethe absenceabsence ofof thesethese circumstances.circumstances. Fluoro-N-methylcathinoneFluoro-N-methylcathinone (4-FMC),(4-FMC), 4-4- hashas specificallyspecifically consideredconsidered thatthat InIn accordanceaccordance withwith 2121 U.S.C.U.S.C. 826,826, 2121 Anilino-N-phenethyl-4-piperidineAnilino-N-phenetlay1-4-piperidine inventoryinventory allowancesallowancesgranted granted tcto CFRCFR 1303.11,1303.11. andand 2121 CFRCFR 1315.1315.11,11, thethe (ANPP),(AMP)), 4-Methyl-W-ethylcalhinone4-Methyl-MdthylcaLhinone (4- individualindividual manufacturersmanufacturers maymay notnot DeputyDeputy AdministratorAdministrator herebyhereby MEC),MEC). 4-Methyl-a-4-Methyl-a- alwaysalways resultresult inin thethe availabilityavailability ofof establishesestablishes thethe 20152015 aggregateaggregate pyrrolidlnopropiophenonepyrrolidlnopropiophenone (4-MePPP),(4-Me1)1313). sufficientsufficient quantitiesquantities toto maintainmaintain anan productionproduction quotasquotas forfor thethe followingfollowing c/pho-Pyrrolidinobutiophononealpha-Ityrrolidinobutiophonone (a-(a- adequateadequate reservereserve stockstock pursuantpursuant toto 2121 scheduleschedule II andand IIII controlledcontrolled substancessubstances PBP), aJpha-Pyrrolidinopentiophenoneelpha-Pyrrolidthopentiophenone U.S.C.D.S.C. 826(a), asas intended.intended. See 2121 CFRCFR andand thethe 20152015 assessmentassessment ofof annualannual (a-PVP),(a-PVP). amphetamineamphetamine (for(for sale),sale), 1303,24.1303.24. ThisThis wouldwould behe concerningconcerning ifif aa needsneeds forfor thethe listlist II chemicalschemicals ephedrine.ephedrine. dihydrocodeine,dihydrocodeine, fentanyl,fentanyt, naturalnatural disasterdisaster oror otherother unforeseenunforeseen pseudoephedrine,pseudoephedrine, andand L hydromorphone,hydromorphone, levorphanol,levorphanol. eventevent resultedresulted inIn substantialsubstantial disruptiondisruption phenylpropanolamine,phenylpropanolemine. expressedexpressed inin marihuana.marihuana. N-(l-Amino-3,3-dimethyl-l-N-(1-Amino-3,3-dimethy1-1- toto thethe amountamount ofof controlledcontrolled substancessubstances gramsgrams ofof anhydrousanhydrous acidacid oror base,base, asas oxobutan-2-yl)-l-pentyl-lH-indazole-3-oxabutan-2-y11-1-penty1-1H-indazole-3- availableavailable toto provideprovide forfor legitimatelegitimate follows:follows: Established BasicBasic classclass 2015 quotas (g)(g) Schedule II (1-Pentyl-1H-indol-3-y!K2,2,3.3-tetrame!hylcyclop/opyl)methanone(1-Penty1-1H-indol-3-y1)(2,2,3.3-totramethylcyclopropylmethanone (UR-144) 15 [1-(S-Fluoro-pertyl)-1H-indol-3-ylI(2,2,3.3-letfamethylcyclopropy1)methancne[1-(5-Fluoro-pen1y1)-1Windol-3-y11(22,3.34etramethylcyclopropyl)methanone (XLR11)(XLR11) 15 1-(1,3-Benzodioxol-5-yl)-2-(methylaiTiino)bctan-1-one(13-Benzedioxol-511)72-(methyla mino)butan-l-one (butylone)(butylone) 15 1-(1,3-Benzodioxol-5-yl)-2-(methylarrino)pentan-l-one1.(1,343enzoiliexid-5-y)-2-(methylaminMpentan-l.one (penlylone)(penlylone) 15 1-(1-Phenylcye[ohexyl)pyrrolidine1-(1-Phenylcyclonexylpyrno1dine 10 1-(S-Fluo'ropentyl)-3-(1-naphlhoyl)lndole145-Fludropeny)-3-(1-naphihoylyndole (AM2201)(AM2201) • 4545 i-(5-Fluofopentyl)-3-(2-iodobenzoyl)indole1-(5-Fluoropenty1)-3-(2-iodobenroyhindole (AM694)(AM694) 4545 1-(1-(2-TTiienyt)eyclohexyilplperidine1-11-(2-11denyl)cyclohexygolperidine 15 112-(4-Morphollnyl)ethy11-3-(1-naphlhoyl)tndele1-(2-(4-Morpholinyl)ethyl]-3-(1-naphthoyl)inclole (JWH-200) 45 1-Buty1-3-(1-naphthoW)indola1-Butyl-3-(1-naphthoyl)indole (JWH-073) . 45 1-Cyclohexylelhy1-312-malhoxyphenylacetyl)indoleVCyclohexylelhyl-3-(2-melhoxyphenyl3cetyl)indole (SR(SR-18-18 and RCSRCS-8)-8) 45 1-Hexy1-3-(1-naphlhoyl)indolel-Hexyl-3-(1-naphihoyl)indole (JWH-019) — 45 1.Methyl-4.pheny1-4-propionoxypiperldlnel-Metbyl-A-pbenyM-prcpienoxypipe/Jdine 2 45 1-Penlyl-3-(1-naphlhoyl)indole1-Penly1-3-(1-naphthayl)indole (JWH-016(JVVH-018 and AM678)AM878) 45 1.Penly5342-chlorophenylacelyl)indole1-Penlyl;3-(2-cblofopbcnylacelyl)indole (JWH-203) 45 (JWH-203) 45 1-Pardyl-3-(2-melhoxyphenylacetyl)inclolel-Peniyl-3-(2-methoxyphenylacetyl)indole (JWH-250) .. 45 1•Per5y1-344-chlaro-1-raphthaylyndoleVPenlyl-3-(4 Vol. I Page 852852 -O -a '43 Z N 2 9 CO > 5 .2 u •a 2 N M V u u. w O CO E IO a. C o a 6 o BO 03 u 53218 Federal03 Register/Vol. 79, No. 1 7 3 /Monday, September 8, 2014 /NotiCeS sj «» |I Uj£ s 1 & Established 3 3 Basic class 2015 quotas (9) U>tfl^U>^ggU|U>OOO^tf)^N ' 1 CD Z o 8 2 w. 5 i\ I Si !M £ a io *r Itlllliliis mgiiiiic sf £ <0 q» 2-(44odo-2.5-dImethexyphenyl)-N-(2-methoxybonzyl)ethanamlne (251-MB0Ms; 2C-1-NBOMe; 251; Cimbi-5) • 15 cT 1 • s I I S 2-(Methylemlno)-1-phenylpentan-1-one (pentedrone) ; 15 ! 2,5.Oimethoxy-4-ethylamphotamine (00E7) 1 25 I ! 1 II I i 2,5-Olmethoxy-4-ntropylthiophenethylamine Hiiliii! 25 1 Z5-Dimethoryamphetamlne Hi 25 !|||||||IIIIIIIIIIIIUIIIIIIIIiiiiiiiiiiiiii!iiiiiim !!!iiiii!!Iliiil!llEfli!liIliillli!Ililiiililllli!!!l!! i 1 i 2-14-(Ethylthio)-2,5-dimelhozyphenyliethanamine (2C-T-2) MM 30 T 1 1 I 2(4-(Isopronyllhio)-2,5-dimethoxyPhanyllethanamine (2C-T-4) :l!li! 30 ill 1 ! ! i iiili ; i I 3,4,5-Thmetho)ryampheMmine mty 25 i ! 1 I i i ! i 3,4-Meltslenedioxyamphotamine (MDA) : 55 M 1 ! I ; I 3,4-Melhylenerfoxymethamphetamine (M DMA) ! 50 1 M 3,4-Meihylenedioxy-Methylamphelamine (MOEA) I 40 f I : j I 3,4-Melhylenedioxy-MmelhythathInone (methylene) I 50 is 3,4-Melhylenedioxypyrovalerone (MOPV) 35 i i 3-Fluora-At-melhylcathinone (3-FMC) 1 15 1 1 2 3,,Melhyllentanyl 1 ^ 3-Methylthielentanyl in 2 ! i i I 4-Bromo.2,5-dimelhexyamphetamme (00B) I 25 ! 25 443rome-2,5-dimethozyphenethylamine (2.08) ! 4-Fluom-Mmethyleathinene (4-FMC) i 16 1 i i •; ! \ \ I i i 4-Methoxyamphetamine ii 100 1 4-Methyl-2,5-dimethoxyamphetamlne (DOM) 25 1 4-Methylaminorex i 25 1 4.Methyl-N-ethyleathinene (4-MEC) ..iiitli 15 H 45 4-MethypNmelhylcaOinone (mephedrone) , I II Ml ! ! • 4•Methyhapyrrolidinoptopiophenene (4-mePPP) IJI 15 I§1 1 Is- 5-(1,1-Dimethylhcely1)-2-81FISS)-3-hydroxytyclohexyll-Phenol - 68 1 5-(1.1-DImethyleety1)-2-81F1,35)-3-hydroxycyclohexyll-phenol (cannabicyclohexanola or CP-47,497 C6-homolog) 53 ; j SMethoxy-3.4-mothylenedioxyamPhetarnine .. l. 25 II II! if! ! • i : I 5-Mathoxy-N.MdlisoproPyltrypiamine 1 25 ! ! I i I 5-Methmey-N,Mdimethylltyptamine 1 25 f ! M i 2 I 1 Acelyka/pha-methyllentanyl C4 f M I • M 1 2 AcetyldihydrocOdelne flllllliilll J i : M h I ; 2 1 Acetylmethadol CM j ! I 1 I 1 2 i Allyiprodinc C-J I 1 i ! ! 1 i 2 M 1 Alphacetylmethadol CM i 1 5 in 25 a(phatthyltryptamine Alphameprodlne , ! 2 Alphamelhadel i ! 2 I : \ ! I I ! I era-Methyllenlanyl ii 2 2 alpha-Methylthiolentanyl W»-r-CI alpha-Melnyltryetamine (AMT) ui 25 i I I i j i i I 15 alpha-Prolidinobutiophenene (“438P) aiplia-Pyrrolidinopentiophenone (a-PVP) 15 i j Amino= . 1 25 II : lllln ll"" M : ! i Benzylmorphine 1 2 : :- 1 : ! i Betacolylmethadol ii 2 1 bota-Hydroxy-3-melhyllenlanyl ; 2 1 : : I : : beta-Hydroxylentanyl ii 2 1 2 B atom optedIna 1 : I I ! : ! : Beta meth add 1 4 ll Betaprodlne 1 2 i ; I I X I I S » I 1 3 i Bufotenine N. 1 calthnone ii 70 ! O Codeine methylbromido m 1 ; I : II l|!! i • MM: i 1 305 Codeine-ALoxide 1 I : 1 5 Desomorehine M II : 1 25 Diethyltryptemine (/) ; li \ I : 1 50 « O o. 8 Difenexin n 11 MM ; ! : i : 1 3,990,000 Dihydromorphine C*3 : ; : Dimethyltryptamlne 1 3 II M Dipipanone t M : : g 8 ™. Feneihylline s II ; N ! i : 70,250,00 gamma-Hydroxybutyrth acid «M ! M 2 Heroin CM III I M : : Hydromerphinel C* M i 5 : MI Hydroxypethidine in Mi M M : : HI ill! Mil il : I IS : IQOUJOlflifl thogaine OOCN II o ; N i : • 3 «». Lysergic acid diethylamde (LSD) 8 2 j I : : : : 125.00 J Marihuana 1 n M 2 Mescaline «*{S 1 Melhaqualone I 1 1 ] 1 2 Melhcathlnone 1 o \ ! I ; i ! ; i I I i I I Methyldesorphlne i co io co 0_ a) O) Vol. I PageCD 853 Federal Register/Vol.Register/ Vol. 79, No. 173173/Monday, /Monday, September 8, 2014/Notices 53219 EstablishedEstaDlished c Basic class 2015201 5 quotas (g) MethyldlhydMelhyldlhydromorphine romorphine 2 Morphine mothythromidemethytbromide 5 Morphine methylsollonatemethylsulfonate 5 Morphine-ALoAdeMorphine-ffcxide 350 N-(1-Adamanly1)-1-penty1-1H-indazde-3-carboxarnide(V-(1-Adarnanlyl)-1-pcntyl-1H-indazole-3-carboxamide (AKB4B)(AKB48) 1515 Ar(1-Arnino-3,341methyl-1-oxobutan-2-y1)-1-penty1-1H-indazole..3.carboxamide7A(1-Arnlno-3,3-dlmethtf-1-oxobutan-2-yl)-1-pentyl-1H-indazole-3-earboxaniide (AOB-PINACA)(ADB-PINACA) 1515 N-(1iV-(1-AmIno-3-meUiyl-1-oxobutan-2-yl)-1-(4-flijorobenzyl)-1H-lnda20le-3-carboxamide -Arnino-3-methyl-l-oxobutan-210-1-(4.fluorobem)1)-1H-Indazole-3-carboxamide (AB.FUBINACA)(AB-FUBINACA) .. 1515 (.1,AuDimelhylamphetamineN.W-Dimelhylaitiphetamine 25 NaphihylpyrovaleroneNaphlhylpyrovalerone (naphyrone) - - 1516 MBenzylpiperazineAf-Benzylpiperaane 25 N-Ethyl-1-nhenylcyclohexylamlneW-Ethyl-1-phenylcydohBxytamlne 5 AtEthylampheramineN-Ethylamphetamine 24 N-Hydroxy-3,4-methylenedioxyamphetamineN-Hydroxy-3,4-meihylenedioxyamphetamlne 24 NoracymelhadolNoracymethadoi 2 NorlevorphanolNorlevorphanoi 52 Normetha.doneNormethadone . 2 Normorphine 1B18 PhenornorphanPhenomorphan 2 PsilocybinPsilocyblr 30 Psilocyn 30 Quinolin-811Ouinclin-8-yl 1-(5-quoropenty1)-1H-Indole-3-carboxylate1 (5-fluoropentyl)-1 rif-lndole-3-carboxylate (5-fluoro-P8-22;(5-fluoro-PB-22; 5F.PB.22)5F-PB-22) 1515 Quinolin-811Quinolin-8-yl 1-panly1-1H-indole-3-carborylate1-pentyl-1H-indole-3-carboxylate (P13-22;(P8-22; QUPIC) 1515 TetrahydrocannahinolsTetrahydrocannabinols 497,500 ThiofentanylThiolentanyl 2 1010 Trimeperidine . 2 Schedule II • 1-Phenyloyclohexylamine1-Phenyfcyclohexylamln# 5 1-Pipeddinocyclohexanecarbonitrile1-Plperidinoeyclohexanecarbonitrile 5 4-AnNno-N•phenethyl-4-piperidine4-Anltino-N-phenethyl-4-piperidine (ANPP) 2,687.5002,687,500 Allentanll 17,75017,750 AlpheprodineAlphaprodine 3 AmobarbitalAmobarOltal 25,125 c Amphetamine (for conversion) 21,875.00921,875.000 Amphetamine41°rAmphetamine (for sale) 37,500,00037,500.000 CarlentanilCaiientanil 1919 Cocaine 275.000275,000 Codeine (for conversion) 50,000.000 Codeine (for sale) 49,500.000 DextropropoxypheneDcxtropropoxyphene 1919 Dihydrocodeine 226,375 DiphonoxylateDiphenoxylate 1,337,5001,337.500 ECO011ifleEcgonine 174.375174.375 Ethylmorphine 3 Fentanyl 2,150.000 Glutethimide 3 Hydrocodone (for conversion) 137,500137.500 Hydrocodone (for sale) 99,625,000 Hydromorphone 7,000.000 IsomethadoneIsomefhadone 5 Levo-alphacelylmethadol (LRAM)(LAAM) 4 LevomathorphanLevomethorphan 5S Levorphanol 7.125 UsdexamfetamineLisdexamfetamire 29,750,000 Meperidine 6,250,000 Meperidine IntermediateIntermediaie-A-A 6 MeparidineMeperidine IntermediateIntermediale-B-13 1111 meparldneMeperidine IntermediateInfermediate-C-C 6 MetazoclneMetaeoelne 1919 Methadone (for sale)safe) 31,675,000 Methadone Intermediateintermediate 34,375.00034,375,000 Methamphetamlne 2,061,3752,051,375 (1,250,000(1,250.000 grams of favo-desoxyephedrine/evo-desoxyephedrine for use in a nonnon-controlled,-controlled, non-prescription product; 750,000750.000 grams for methamphetaminemethampheiamine mostly for conversion to a schedule-Ill111 product; and 61,375 grams for methamphetaminemeihamphetamine (for(far sale)] MethylphenidateMeihyiphenldate 83,750,000 MorphineMorpnine Pr(for conversion) 91,250,000 Morphine (for sale) 62,500,000 NNabilone Io'l ne 16,75018,750 c '7,50000017,500,000 Noroxymorphone (Ion(for conversion) .. Vol. I Page 854 53220 Federal Register/Vol. 79, No,No. 173/Monday,173/Monday, September 8, 2014/Notices Established L Basic class 2015 quotas (0)(g) Noroxymorphone (for(lor sale) .. 1,475,0001.475,000 Opium (powder) 112500112,500 Opium (tincture) 667,500 35,000,000 OripavIneOripavlne 35,000,000 Oxycodone (for(lor conversion) ..... 8,350.0008,350,000 137.500,000137,500,000 Oxycodone (for sate)sate] 29,000,000 Oxymorphone (for conversion) . 29,000.000 Oxymorphone (for sale) 7,750,000 35,000,000 Pentobarbital 35,000,000 6a PtienazodnePhenamoine 19 Phencyclidine 19 3 PhenmetrazinePhenmetrazire 3 9,376,030 Phenylacetone 9,375,000 3 flacemethorphan 3 3,750 RemaentanaRemifentanil 3,750 215,003 Secobarbital 215,003 6,255 SulantanaSufentanil 6,255 12,500,000 Tapen134°1Tapenladol 12,500.000 125,000.000 ThebalneThepalne 125,000.000 List I Chemicals 1,000,000 Ephedrine (for conversion) 1,000,000 4,000,000 EphedrlneEphedrine (for sale) 4,000,000 PhenylpropanolaminePhenylpropenolamine (for conversion) 44,800,000 Phenylpropanolamine (for sale) 6500.0006,500,000 PseudoepheddnePseudoephedrine (for conversion) 7,000 nseudoepheddnePseudoephedrlne (for sale) .. 224,500.000224,500,000 The Deputy Administrator also interchange meeting entitled "Realizing nnco.nano.gov, NNCONNCO. Additional establishes aggregate production quotas thetho Promise of Carbon Nanotubes— • information is posted at:t: http:// for all other schedule 1I and II controlled Challenges,Challenges. Opportunities and the nono.gov/2014CNTTechInterchenge.narto.gov/20l4CNTTech[nterchange. substances included in 21 CFR 1308.11 Pathway to Commercialization" on Registration: RegistrationRegist align opens on c • and 1308.121306.12 at zero.zero, In accordance with September 15, 2019.2014. The meeting will September 8, 2014. Due to space 21 CFR 1303.13 and 21 CFR 1315.13, be sponsored by the National limitations, pre-registrationpre-registration for the NanatechnologyNanotechnology Initiative (NM)(NN1) and co- upon consideration of the relevant technical interchange meeting is sponsored by the National Aeronautics factors, the Deputy Administrator may required. Written notices of production and Space Administration (NASA).(NASA], The adjust the 2015 aggregate production participation by email should be sent to annual needs objectives of this meeting are to identify, quotas and assessment of annual needs [email protected]@nnco.nano.gov or mailed to needed. discuss, and report the technical as needed. ➢ianaDiana Petreski, 4201 Wilson Blvd.. barriers preventing thetho production of Dated: September 2.2, 2014. Stafford II, Suite 905,405, Arlington, VA carbon nanotube-based materials with ThamesThomas M. Harrigan.Harrigan, 22230. Please provide your full name, electrical and mechanical properties 22230. Deputy Administrator. or mailing Deputy approaching theoretical values, and to title, affiliation and, email. . . . (FR(FR not.Doc. zets-zissa2014-21280 Filed 9-5-14: 8:45 coam]ol explore ways to overcome these barriers.barriers, address when registering. Registration is CHUNGGRAM CODE 4110-09-94410-09-P Obstacles preventing the full on a first-come,first-come, first-servedfirst-served basis until exploitation of the multifunctional capacity is reached. Written or nature of carbon nanolubenanotube materials will electronic comments should be OFFICE OF SCIENCE AND also be discussed. This oneone-day-day meeting submitted by email to dpetreski@ TECHNOLOGY POLICY will assemble some of the Nation's nnco.nano.gov until doseclose of business leading experts in carbon nanotube September 10.10. 2014. National Nanotechnology Coordination research and development, as well as Meeting Accommodations:Accommodations; Office Federal executives and experts from the Federal Individuals requiring special government, academia,academia. and private Nanoscale Science, Engineering, and accommodation to access this meeting sector. Technology Subcommittee; Committee should contact Diana Petreski at 703-703 on Technology, National Science and DATES:dates: The technical interchange 292-7922 at least five business days Technology Council; Meeting meeting will be held Monday,Monday. prior to the meeting so that appropriate September 15,15, 20120144 from 8:00 a.m. until arrangements can be made. ACTION: Notice of public meeting. 5:15 p.m. Ted Wackier,Wackier. . AD0RESSES:ADDRESSES: The technical interchange SUMMARY: The National Nanotechnology Deputy Chief of StaffStaf/and and Assistant Director. meeting will be held at the National Coordination Office (NNCO),(NNCO). on behalf Piled 9-5-14: S:4S amlami Aeronautics and Space Administration |FRIFR Doc.Dec. 2014-21201 riled 9-5-14; B:44 of thothe Nanoscale Science, Engineering, (NASA) Headquarters, 30030Q E Street BILLINGBILLINO CODE P and Technology INSET)(NSET) Subcommittee Washington, DC 20546. of the Committee on Technology, Southwest, NNational t onel Science and Technology FOR FURTHER INFORMATION, CONTACT: Dr. Council (NSTC), will hold a technical Tarek Fadel,Fade I, 703-292-7926,703-292-7926. Vadat@tfadel® Vol. I Page 855 1 &i2! CODEINECODEINE 22,756.72822,756.728 21,747.58621,747.588 -4.43%-4.43% 21,716.91521,716.915 -0.14%-0 14% 27,997.46127,997.461 28.92%28.92% •:piHYb^p^bEiNE;;::;:-..0,1f5YORPcOPPNE. ., '"' ••:•' v.V.#Si02i • 'v ^ssz-vy^-' ^5&a%-W;; ;.:r-;:si3i4:: ;:\^.;;.--9or7^^^;.:}--^ii^:1 136 d:30* DIPHENOXYLATE DIPHENOXYLATE 413.016413.016 411.425411.425 -0.39%-0.39% 385.932385.932 -6.20%-6.20% 369.646389.646 ' 0.96%0.96% v:141;#7, .DRONABINOL'LDR0441401-: " ' : V' ' j-'. V, v 1e6:04 • - '4'^6%4:10% ;:.' . • • -A9% .:;: 1/03105 -.W^tar4.W, EPHEDRINEEPHEDRINE 1,972.0901,972.090 2,079.3012,079.301 5.44%5.44% 2,234.6292,234.629 7.47%7.47% 2,133.2842433.284 -4.54%-4.54% ;-Y?' 0,15% 1.01% HYDROCOOONE 63,179.515 61,710.790 -2.32%-2.320/a 56,372.63556,372.635 -8.65%-8.65°A, 50,046.77350,046.773 -11.22%-11.22% •* ,s1' wSgoHoftpH^ENYOROMOkPHONe - ; ; : : ; v.:::-r.-4^%V^^i}7K^>-.1;75;41W. • A-4% LEVORPHANOL 1.544 2.314 49.87% 2.691 16.29% 2.882 7.11% , , • ;uSDE»WEtAMlN6>^'^v;\:419DE.CAMEETXMINE1 :it: 1114.0 •! ri'133 0 kY ° MEPERIDINE 1,880.965 1,522.736 -19.04%-19.04% 1,243.493 -18.34%-18.34% 1,147.0861,147.088 -7.75%-7.75% :::67,77.086'.; , . ' 0E0744 'O' ' ' '4 ",-14:34% , ''2'.5,isui§1.- .. , . r s V l" >:v •!,; • -5;5456 , 4,957.31®4.952210" - -.5--5.060%0510 METHAMPHETAMINE 14.399 13.192 -8.38% 11.910 -9.72% 11.278 -5.30% 20,17E.674, METHYU>ttENIOATe/4ETNYLPflENIDATE**•* :'-.':iX,7S9J7te210Sa$ 9 " ' 20,137:90420;13X-9114 ;.•- ' , ';-7,4S%..4 .46954 : 20,175,671 ; :. 0Jl9%049% • :• 18,103.33i18,993.332 . ' -V -6.36%. MORPHINE 28,706.443 26,272.879 -8.48% 24,603.452 -6.35% 24,084.883 -2.11% NALBUPHINE ./ - 63.599 41.766; -3433%0 NRISIOMiNE. , - 63.599 :• . . 41.766 : •' ' -34.33% : ' • l?4d;8i5S; ; ';:"-2.15%\-. ^ -10.26% NALOXONE 433.684 481.367 10.99% 522.199 8.48% 550.850 5.49% 1ACTRECONLNALTREXONE- . . :;'646.518''646•510 ; , ' 743.S93243,553 . . is.02%15.02% ,: . -927,2449n.244 ; ! 24,70%24.70% : . . i,3M:8381.388-08 49:78%49.78% NoraxymorphoneNoroxymorphone products (sum) 1,143.801 1,266.726 10.75% 1,490.310 17.65% 1,976.362 32.61% "J.-: _4,41% ;OPIpeiUW ; 7: : s a' , . . Y^O.96680.966 •vv : 74497 V :' : 76.702767<» y y 49294 ':y74,97T74; 9-12/ , ' /;.-2.25%-2•25% OXYCODONE 66,704.849 60,357.506 -9.52% 58,911.473 -2.40•2.40%0/0 59,620.924 1.20% dXYKORPHONE . ; • -4.84% 346,64 • 1^553;' ' , 0.84% PENTAZOCINE 698.430 565.292 -19.06% 422.871 -2S.19%-25.19% 428.603 1.36% PENTO0401TALRENTOBARfelTAL:, ; ••i 4&6i2 ;. • j.-«.p3%' -{'SO '(S3£7^:p77j^2:. ,'^-04% PHENYLPROPANOLAMINE 2.966 #DIV/0! 1.058 -64.34% 0.792 -25.11% '08ElfreW^EPflE^NE**.*:66.0H EDRiNE 4, ' •;:i8718^53-^>186,43&i»U:187.867.353.' '186,416285- V; \-"^;T6%:'7 181,452,065lWi4S^-;:V ' I -1-2:^%^ .103,27}^ y -43ib9% REMIFENTANIL . 1.1051.105 1.1581.158 4.75% 1.2251.225 5.83% 1.2701.270 3.71% v V SBSOBARBTTM. - - : V;-. 11&67P;5.670 , . ,Y;/ 12.Q40i2.Q4P - ^ : -23.11%-23/17% '•'.'•.••• 111431:470.'" /V>42?3%\`13354 ;112.4&0.2•48D' f:'8.BlVc8' 81% SUFENTANIL 0.051 0.047 -8.82%-8.62% 0.041 -11.40% 0.042 1.94% Tt^enVaPolV4. 6414 61:1' . : • "'V '." 6,388.4486,?8B.'449;.‘ -V -55;98&7.66a 89.$ 6. '.••••-6:i4%-• -6.24% . >••• 55;645;,768..6454766 'y'; Y.7:-5:?4%.75.74% • ' 5,6481XS,642.812 : 4-95%rQ;lS5% 2015 Data based on Jan -• Mar 2015 data * corrected basedbased on historicalhistorical IM5IMS data for d,Id,l andand d "*• addedadded dexmethylphenidate toto mehtylphenidatemehtylphenidate !MSIMS DATADATA 20122012 -• 20152015 (est)(est) •••• «* corrected based on IMSIMS capture of OTC marketmarket Vol. I PagePage 856 •"V?" FederalFederal Register/Vol.Register/ Vol. BO,80, No.No. 116116 /Wednesday,/Wednesday,Y, JuneJune 17,17. 20152015/Notices /Notices 3969334693 managementmanagement strategiesstrategies forfor FireFire IslandIsland continuationcontinuation oror recurrencerecurrence ofof materialmaterial thethe FederalFederal RegisterRegister onon JanuaryJanuary 26.26, NationalNational SeashoreSeashore forfor thethe nextnext 1515 toto 2020 injuryinjury toto anan industryindustry inin thethe UnitedUnited 2015.2015. BOBO FRFR 3982,3982, SiemensSiemens HealthcareHealthcare c yearsyears toto supportsupport thethe protectionprotection ofof StatesStates withinwithin aa reasonablyreasonably foreseeableforeseeable Diagnostics,Diagnostics, Inc.,Inc., Attn:Attn: RA,RA, 100100 GBCGBC importantimportant naturalnatural rotresources-mimes andand time.time. Drive,Drive, MalLstopMailstop 514.514. Newark.Newark. DelawareDelaware processes;processes: significantsignificant recreationrecreation 1970210702 appliedapplied toto bebe registeredregistered asas aa BackgroundBackground resources;resources; culturalcultural resourcesresources ofof national,national, manufacturermanufacturer ofof certaincertain basicbasic classesclasses ofof state,state, andand locallocal significance;significance; andand TheThe Commission,Commission, pursuantpursuant toto sectionsection controlledcontrolled substances.substances. NoNo commentscomments oror residentialresidential communities.communities. 751(c)751(c) ofof thethe TariffTariff ActAct ofof 19301930 (19(19 objectionsobjections werewere submittedsubmitted toto thisthis notice.notice. TheThe parkpark isis composedcomposed ofof twotwo distinctdistinct U.S.C.U.S.C. 1675(c)),1675(c)), institutedinstituted thesethese reviewsreviews TheThe DEADEA hashas consideredconsidered thethe factorsfactors inin unitsunits—the—the batherbarrier islandistand thatthat runsruns onon AprilApril 1,1, 20142014 (79(79 FRFR 18311)18311) andand 2121 U.S.C.U.S.C. 823(a)823(a) andand determineddetermined thatthat parallelparallel toto thethe southsouth shoreshore ofof LongLong determineddetermined onon fulyJuly 7,7, 20142014 thatthat itit wouldwould thet}je registrationregistration ofof SiemensSiemens HealthcareHealthcare IslandIsland andand thethe 613613-acre-acre WilliamWilliam FloydFloyd conductconduct fullfull reviewsreviews (79(79 FRFR 42049,42049, fulyJuly Diagnostics,Diagnostics, Inc.Inc. toto manufacturemanufacture thethe EstateEstate situatedsituated onon thethe southsouth shoreshore ofof 111.IB. 2014).2014). NoticeNotice ofof thethe schedulingscheduling ofof basicbasic classesclasses ofof controlledcontrolled substancessubstances isis LongLong IslandIsland nearnear thethe easteast endend ofof FireFire thethe Commission'sCbmmission's reviewsreviews andand ofof aa consistentconsistent withwith thethe publicpublic interestinterest andand Island.Island. ToTo addressaddress thethe specificspecific needsneeds ofof publicpublic hearinghearing toto bebe heldheld inin connectionconnection withwilh UnitedUnited StatesStates obligationsobligations underunder thesethese twotwo distinctdistinct units,units, thethe DraftDraft GMP/GMP/ therewiththerewith waswas givengiven byby postingposting copiescopies Internationalinternational treaties,treaties, conventions,conventions, oror EISEIS includesincludes twotwo setssets ofof alternatives.alternatives. ofof thethe noticenotice inin thethe OfficeOffice ofof thethe protocolsprotocols inin effecteffect onon MayMay 1,1, 1971.1971. TheThe OneOne addressesaddresses parkpark-wide-wide alternativesalternatives Secretary,Secretary, U.S.U.S. InternationalInternational TradeTrade DEADEA investigatedinvestigated thethe company'scompany's forfor FireFire IslandIsland NationalNational SeashoreSeashore withwith aa Commission.Commission, Washington,Washington, DC,DC, andand byby maintenancemaintenance ofof effectiveeffective controlscontrols primaryprimary emphasisemphasis onon thethe harrierbarrier islandisland publishingpublishing thethe noticenotice inin thethe FederalFederal againstagainst diversiondiversion byby inspectinginspecting andand andand includesincludes aa nono-action-action alternativealternative andand RegisterRegister onon NovemberNovember 14.14. 20142014 (79(79 FRFR testingtesting thethe company'scompany's physicalphysical securitysecurity twotwo actionaction alternatives.alternatives. TheThe otherother setset ofof 63299).68299). TheThe hearinghearing waswas heldheld inin systems,systems, verifyingverifying thethe company'scompany's alternativesalternatives focusesfocuses specificallyspecifically onon thethe Washington,Washington, DC,DC, onon MarchMarch 26,26, 2015,2015, compliancecompliance withwith statestate andand local laws,laws, WilliamWilliam FloydFloyd EstateEstate andand includesincludes aa no.no- andand allall personspersons whowho requestedrequested thethe andand reviewingreviewing thethe company'scompany's actionaction andand aa singlesingle actionaction alternative.alternative. opportunityopportunity werewere permittedpermitted toto appearappear inin backgroundbackground andand history.history, TheThe DraftDraft GMP/EISGMP/EIS alsoalso incorporatesincorporates personperson oror byby counsel.counsel. Therefore.Therefore, pursuantpursuant toto 2121 U.S.C.U.S.C. plansplans farfor thethe OtisOtis PikePike HighHigh DunesDunes FireFire TheThe CommissionCommission mademade thesethese 623(a).823(a), anda/id inin accordanceaccordance withwith 212) CFRCFR IslandIsland WildernessWilderness andand includesincludes aa draftdraft determinationsdeterminations pursuantpursuant toto sectionsection 1301.33,1301.33, thothe aboveabove-named-named companycompany isis WildernessWilderness StewardshipStewardship PlanPlan forfor publicpublic 751(c)751(c) ofof thethe TariffTariff ActAct ofof 19301930 (19(19 grantedgranted registrationregistration esas aa bulkbulk reviewreview concurrentconcurrent withwith thethe DraftDraft GMP/GMFI U.S.G.U.S.C. 1675(c)).1675(c)). ItIt completedcompleted andand filedfiled manufacturermanufacturer ofof thethe basicbasic classesclasses ofof EIS.EIS. itsits determinationsdeterminations inin thesethese reviewsreviews onon controlledcontrolled substancessubstances listed:listed: June 11, 2015,2015, TheThe viewsviews ofof thethe FORFOR FURTHERFURTHER INFORMATIONINFORMATION CONTACT:CONTACT: June 11, EllenEllen Carlson.Carlson, NI'S/NortheastNFS/Northeast Region,Region, 1515 CommissionCommission areare containedcontained inin LISITCUSITC ControlledControlled substancesubstance ScheduleSchedule Publication 45384538 (June(June 2015),20 15). entitledentitled . StateState Street,Street, Boston,Boston, MAMA 02019.02019. Phone: CitricCitric AcidAcid andand CertainCertain CitrateCitrate saltsSofts TetrahydreeennablnolsTetrahydrocannabinols (7370)(7370) I L (617)(617) 223-5046.223-5048. Email: FireIsland_Firejslar\d_ fromfrom CanadaConcdq midand Chino:China: InvestigationInvestigation EcgonineEcgorine (9180)(9180) II GlOPOnps.gov.GMP®nps.gov. II Nas.Nos. 701701-TA-4SS-TA -456 andand 731731-TA-l-TA -1151-151 Morphine (9300)(9300) Dated: June1,1, 2015.201S. Thebaine (9333) II Dated: June 11521152 (Review).(Review). (9333) MichaelMichael A,A, Caldwell,Caldwell, ByBy orderorder ofof thethe Commission.Commission. RegionalRegional Director.Director, NortheastNortheast Region,Region. NationalNational TheThe companycompany plansplans to.produceto produce thethe 2015. PorkPark Service.Service. Issued:Issued: luneJune 12,12, 201S. listedlisted controlledcontrolled substancessubstances inin bulkbulk toto LisaLisa R.R, Barton,Barton, IFRIFR DOC,DOC, 2015-142015-14927 92 7 FledHied 6-16-15:6-16-1S; 6:450:4S am]ami be used inin thotho manufacture ofof reagentsreagents SecretarySecretary toto thethe Commission. andand drug calibrator controls which are BILLINGBILLING CODECODE 4.110MI9-WV-P-WV-P drug calibrator controls which are intIFRnoc. non. 2015-14a032015-14363 FiledFiled 6-16-156-16-1S; 88:45 aream] DEA exempt products. BILLINGBILLING CODECODE 7020-02.TOM-OW InIn referencereference toto drugdrug codecode 7370737Q thethe companycompany plansplans toto bulkbulk manufacturemanufacture aa INTERNATIONALINTERNATIONAL TRADETRADE syntheticsynthetic tetrahydrocannabinol.tetrahydrocannabinol. NoNo COMMISSIONCOMMISSION DEPARTMENTDEPARTMENT OF JUSTICE other activity forfor thisthis drug codecode isis (investigation(investigation Nos.Nos. 701701-TA-456-TA-456 andand 731731-- authorizedauthorized forfor thisthis registration.registration. TATA-l-1151-1152151-1152 (Review)](Review)] DrugDrug EnforcementEnforcement Administration Dated: funoJune 11.2015.11. 2015. CitricCitric AcidAdd andand CertainCertain CitrateCitrate SaltsSalts [Docket[Docket No.No. DEA-3921OEA-392] JosephJoseph T.T. RannarrIsl,R&nnaz2i$l, FromFrom CanadaCanada andand ChinaChina DeputyAssistanDepuly Assistant t Administrator.Administrator. Manufacturer of Controlled Manufacturer of Controlled (FR(FT? Doc.Doc. 2015-145122015-14912 FledFiled 5-16-15;S-16-15; 8:.158:45 am|ml DeterminationDetermination Substances Registration:Registration: Siemens BILLINGSILLING CODE 4410-09-14410-09-P1 On thethe basis of thethe record I1 developed HealthcareHealthcare Diagnostics,Diagnostics, Inc.Inc. inin thethe subjectsubject five-yearfive-year reviews, thethe ACTION: Notice of registration. Dnitecl,StatesUnited-States International Trade DEPARTMENTDEPARTMENT OF JUSTICE CommissionCommission ("Commission")("Commission") SUMMARY:SUMMARY: SiemensSiemens HealthcareHealthcare „ determines,determines, pursuant toto thethe TariffTariff ActAct ofof Diagnostics,Diagnostics, Inc.Inc. appliedapplied toto bebe registeredregistered Drugaru9 EnforcementEnforcement AdministrationAdministration 1930.1930. thatthat revocationrevocation ofof thethe asas aa manufacturer ofof certaincertain basicbasic [Docket[Docket No.No. 0EA-4119OEA-411F] countervailing duty order on citric acid classes of controlled substances.substances. The and certain citrate saltssalts from China and Drug Enforcement Administration the antidumping duty orders on citric (DEA)(DEA) grants Siemens Healthcare acidacid andand cercertain lain citrate saltssalts from China Diagnostics. Inc. registrationregistration asas aa andand CanadaCanada would be likelylikely toto leadlead toto manufacturer ofof thosethose controlledcontrolled ,aw-> AGENCY: DrugDrug Enforcement substances.substances. 1 TheThe recordrecord leIs defineddefined inin sec.sec. 201.21020?. 2(f) ofof thethe Administration.Administration, Department ofof Justice.Justice. SUPPLEMENTARY INFORMATION:INFORMATION; By notice L CCommission's m 'RIRules oftractPractice anend Procedureel I(19 ACTION: FinalF;na, order.order, CFR 207.1(01207,2(0). dated January 9,9. 2015, and published in - — - Vol. I Page 874 t 3469434694 FederalFederal RegisterRegister/Vol. / V01. 80,80, No,No. 116/Wednesday,116/ Wednesday, JuneJune 17,17, 2015/Notices2015/Notic.es SUMMARY:SUMMARY: ThisThis finalfinal orderorder establishesestablishes AdministratorAdministrator ofof thethe ➢EA,DBA, 262B CFRCFR appreciatesappreciates thethe supportsupport forfor thisthis adjustedadjusted thethe adjustedadjusted 20152015 aggregateaggregate productionproduction 0.100.0.100. 2015201S aggregateaggregate productionproduction quotaquota forfor c quotasquotas forfor difenoxin,difenoxin. diphenoxylatediphenoxylate (for(for difenoxin,difenoxin, diphenoxylatediphenoxylate (for BackgroundBackground (for conversion),conversion), andand marijuana.marijuana. conversion),conversion), andand marijuana,marijuana, whichwhich isis initial 2015 OATES:DATES: ThisThis orderorder isis effectiveeffective JuneJune 17,17. TheThe DEADEA establishedestablished thethe initial 201S intendedintended toto provideprovide forfor thethe estimatedestimated aggregateaggregate productionproduction quotasquotas andand 2015.2015. scientific,scientific, research,research, andand industrialindustrial needsneeds assessmentsassessments forfor annualannual needneed onon ofof thethe UnitedUnited States.States. 5041FOR FURTHERFURTHER INFomitematiINFORMATION cMITAcT:CONTACT: JohnJohn SeptemberSeptember 8,8, 20142014 (79(79 FRFR 53216).53216). ThatThat R.R. Scherbenske,Scherbenske, OfficeOffice ofof DiversionDiversion noticenotice stipulatedstipulated that,that, asas providedprovided forfor inin DeterminationDetermination forfor AdjustingAdjusting thethe Control,Control, DrugDrug EnforcementEnforcement 2121 CFRCFR 1303.131303.13 andand 2121 CFRCFR 1315.13,1315.13, allall AggregateAggregate ProductionProduction QuotasQuotasfor for Administration.Administration. 87018701 MorrissetteMorrissette Drive,Drive, aggregateaggregate productionproduction quotasquotas andand Difenoxin.DiphenoxylateDifenoxin, Diphenoxylate (for(fnr Springfield.Springfield. VirginiaVirginia 22152.22152, Telephone:Telephone; assessmentsassessments ofof annualannual needneed areare subjectsubject Conversion),Conversion), andand MarijuanaMarijuana (202)590-6812.(202) 59B-6812. toto adjustment.adjustment. BasedBased onon unanticipatedunanticipated InIn accordanceaccordance withwith 2121 CFRCFR 1303,13,1303.13, SUPPLEMENTARYSUPPLEMENTARY INFORMATION:INFORMATION: medical,medical, scientific.scientific, research,research, andand thethe DEADEA hashas takentaken intointo considerationconsideration industrialindustrial needsneeds ofof thethe UnitedUnited Stales,Stales, legalLegal AuthorityAuthority thethe aboveabove commentscomments alongelong withwith thethe thethe DEADEA proposedproposed toto adjustadjust thethe relevantrelevant 20142014 year-endyear-end inventories,inventories, TheThe DEADEA implementsimplements andand enforcesenforces establishedestablished 20152015 aggregateaggregate productionproduction initialinitial 20152015 manufacturingmanufacturing quotas.quotas, 20152015 titlestitles UII andand IIIHI ofof thethe ComprehensiveComprehensive quotasquotas forfor thethe scheduleschedule II andand ❑f! exportexport requirements,requirements, actualactual andand DrugDrug AbuseAbuse PreventionPrevention andand ControlControl ActAct controlledcontrolled substancessubstances difenoxin,difenoxin, projectedprojected 20152015 sales,sales, researchresearch andand ofof 1970.1970. asas amended.amended. 2121 U.S.C.U.S.C. 801-971.801-971. diphenoxylatediphenoxylate (for(for conversion],conversion), andand productproduct developmentdevelopment requirements,requirements, andand Titles.11Titles. II andand IIIIII areare referredreferred toto asas thethe marijuanamarijuana toto bebe manufacturedmanufactured inin thethe informationinformation derivedderived fromfrom additionaladditional "Controlled"Controlled SubstancesSubstances Act"Act" andand thethe UnitedUnited StatesStates inin 2015.2015. TheThe noticenotice ofof applicationapplications forfor manufacturingmanufacturing quotaquota "Controlled"Controlled SubstancesSubstances ImportImport andand proposedproposed adjustmentadjustment waswas publishedpublished inin receivedreceived sincesince thethe AprilApril 8.20158. 2015 ExportExport Act,"Act," respectively,respectively, andand areare thethe FederalFederal RegisterRegister onon Wednesday.Wednesday, publicationpublication ofof thethe noticenotice ofof proposedproposed collectivelycollectively referredreferred toto asas thethe AprilApril 8,8, 20152015 (80(80 FRFK 18867).18867). AllAll adjustmentadjustments toto thethe aggregateaggregate productionproduction "Controlled"Controlled SubstancesSubstances Act"Act" oror thethe interestedinterested personspersons werewere invitedInvited toto quotasquotas forfor difenoxin,difenoxin, diphenoxylatediphenoxylate (for(for "CSA""CSA" forfor thethe purposespurposes ofof thisthis action.action. commentcomment onon oror objectobject toto thethe proposedproposed conversionconversion), , andand marijuana.marijuana. UponUpon TheThe DEADEA publishespublishes thethe implementingimplementing adjustedadjusted aggregateaggregate productionproduction quotasquotas onon consideraticonsideration n ofof thethe above,above, thethe ActingActing regulationsregulations forfor thesethese statutesstatutes Inin titletitle 2121 oror beforebefore MayMay 8,8, 2015.2015. AdministraAdministrator or has determined to ofof thethe CodeCode ofof FederalFederal RegulationsRegulations has determined to Comments Received increase the 2015 aggregate production (CFR),(CFR), ChapterChapter II.II. TheThe CSACSA andand itsits Comments Received increase the 2015 aggregate production quotasquotas forfor difenoxindifenoxin andand marijuanamarijuana Implementingimplementing regulationsregulations areare designeddesigned TwoTwo companies,companies, oneone institutioninstitution ofof beyond tha which was previously toto prevent,prevent, detect,detect, andand eliminateeliminate thethe higherhigher education,education, andand fivefive privateprivate beyond that which was previously proposed.proposed. Regarding the aggregate diversiondiversion ofof controlledcontrolled substancessubstances andand citizenscitizens submittedsubmitted timelytimely commentscomments inin Regarding the aggregate productionproduction quotaquota for diphenoxylate (for listedlisted chemicalschemicals intointo thethe illicitillicit marketmarket responseresponse toto thethe proposedproposed adjustmentadjustment ofof for diphenoxylate (for L conversion the Acting Administrator whilewhile providingproviding forfor thethe legitimatelegitimate thesethese threethree controlledcontrolled substances.substances. TheThe conversion), the Acting Administrator hashas determdetermined ned thatthat thethe proposedproposed medical,medical, scientific,scientific, research,research, andand commentscomments fromfrom thethe institutioninstitution ofof higherhigher aggregate p oduction quota adjustment industrialindustrial needsneeds ofof thethe UnitedUnited States. educationeducation andand oneone ofof thethe privateprivate aggregate production quota adjustment Slates. for this sub tance is sufficient to meet ControlledControlled substancessubstances havehave thethe potentialpotential citizenscitizens werewere inin supportsupport ofof thethe proposedproposed for this substance is sufficient to meet thethe current 2015 estimated medical, forfor abuseabuse andand dependencedependence andand areare increasesincreases forfor thesethese threethree controlledcontrolled current 2015 estimated medical, scientific,scientific, research, and industrial needs controlledcontrolled toto protectprotect thethe publicpublic healthhealth substances.substances. TheThe twotwo companiescompanies andand oneone research, and industrial needs ofof thethe Unit d States and to provide for , andand safety.safety. privateprivate citizencitizen supportedsupported thetbe proposedproposed United States and to provide for . SectionSection 306306 ofof thethe ControlledControlled adjustmentadjustment andand requestedrequested furtherfurther adequateadequate rereserve erve stock.stock. SubstancesSubstances ActAct (CSA)(CSA) (21(21 U.S.C.U.S.C. 626)B26) increase'sincrease's toto thethe APQsAPQs toto supportsupport PursuantPursuant toto thethe above,above, thethe ActingActing requiresrequires thethe AttorneyAttorney GeneralGeneral toto research,research, additionaladditional productproduct ' AdministraAdministrator or herebyhereby establishesestablishes thethe establishestablish aggregateaggregate productionproduction quotasquotas developmentdevelopment efforts,efforts, andand increasesincreases inin 20152015 aggreaggregate ate productionproduction quotasquotas forfor forfor eacheach basicbasic classclass ofof controlledcontrolled manufacturingmanufacturing demands.demands. FurtherFurther difenoxin,difenoxin, diphenoxylatediphenoxylate (for(for substancesubstance listedlisted inin schedulesschedules II andand IIII commentscomments receivedreceived fromfrom threethree privateprivate conversionconversion], , andand marijuana,marijuana, expressedexpressed eacheach year.year, TheThe AttorneyAttorney GeneralGeneral hashas citizenscitizens werewere outsideoutside thethe scopescope ofof thethe inin gramsgrams ofof anhydrousanhydrous acidacid oror base.base, asas delegateddelegated thisthis functionfunction toto thethe proposed APQ notice. TheThe DEA follows:follows: Previously Adjusted eslablishedestablished Basic classclass——scheduleschedule II 20152015 quernquota 20152015 quotacuo'a (9) (9)(9) (9) DitenoxinDifenoxin 5050 11,00011,000 MarijuanaMarijuana 125,000125.000 656,000658.000 Previously Adjusted established Basic ciclass—schedulehedule IIII 2015 quota 2015 quotaquota ICU(9) (0)(9) DahenoxylateDiphenoxylate (tor(lor conversion)conversion) 00 75,00075.000 c Vol. I Page 875875 FederalFederal Register/Register/Vol.Vol. 80,80, No.No. 116/116 /Wednesday, 1Nednesday, JuneJune 17,17, 2015/Notices2015 /Notices 3469534695 Dated:Dated:Juno Juno11, 11,2015.2013. BackgroundBackground OnOnMarch March20, 20,2015, 2015,the theDEA DEA ChuckChuckRosenberg, Rosenberg, published a notice titled, "Controlled c Section 306 of the Controlled ActingActingAdntinislra Administrator.tor. Substances: 2015 Proposed Aggregate SubstancesSubstances ActActtfsssfK'c(CSA) (CSA)(21 (21U.S.C. U.S.C.326,826] 826) s^ssr^issssproduction Quotas for Three [FR[FRDoc Doc.2015-14910 CO15-14910Filed Filed6-16-15; a-15-I5:8:45 8:45oml aml Production Quotas for Three requiresrequiresthe theAttorney AttorneyGeneral Generalto to TemporarilyTemporarilyControlled ControlledSynthetic Synthetic BILLINGmustsCODE cane4410-09-P smo-as-P establishestablishaggregate aggregateproduction productionquotas quotas Cannabinoids"Cannabinoids"in inthe theFederal FederalRegister Register controlled forfor eacheachbasic basic classclassof ofcontrolled (8Q(80ra FR ig034]<15034].That Thatnotice noticeproposed proposedthe the suhstancesuhstance listedlistedin inschedules schedules II andandII II 2Q15 aggcegate prodoction quotas for DEPARTMENTDEPARTMENT OFOFJUSTICE JUSTICE 2015 aggregate production quotas for andand forfor ephedrine,ephedrine, pseudoephedrine,pseudoephedrine, AB-CHMINACA,AB-CHMINACA, AB-PINACA,AD-PINACA, andand THJ-THJ- and phenylpropanolamine. The DrugDrugEnforcement EnforcementAdministration Administration and phenylpropanolamine. The 2201.2201. InterestedInterested personspersonswere wereinvited invitedto to AttorneyAttorney GeneralGeneralhas has delegateddelegatedthis this Mmmentcommenton onor or objectobjectt0 to^ theproposed proposed authorsauthorityto to thetheAdministrator Administrator of the [DocketpocketNo. No.DEA-410F] DEA-4109 of the aggregateaggregate productionproductionquotas quotas forforAB- AB- DEA.DEA. 2828 CFRCFR0.100(b). 0.100(b). CHMINACA,CHMINACA,AB-PINACA. AB-P1NACA,and andTHJ- THJ. ControlledControlledSubstances; Substances:2015 2015 OnOnJanuary January 30.30,2015, 2015.the theDEA DEA 22012201on onor or beforebeforeApril April 20,20,2015. 2015.No No EstablishedEstablishedAggregate Aggregate ProductionProduction publishedpublishedin inthe the FederalFederalRegister Registera a finalfinal commentscomments werewerereceived, received. QuotasQuotas torforThree ThreeTemporarily Temporarily orderorderto to temporarilytemporarily placeplace threethree Established Aggregate ControlledControlled SyntheticSyntheticCannabinoids Cannabinoids syntheticsyntheticcannabinoids, cannabinoids.N-(l-amino-3- N-(1-amina-a- AnalysisAnalydis forfor2015 2015 Established Aggregate mothyl-l-oxobutan-2-yl)-l-methy1-1-attobutan-2-y1)-1- ProductionProduction QuotasQuotas AGENCY:AGENCY: Drug Enforcement (cyclohexylmethyl)-lH-indazole-3-(cyclohexylmethyl)-1H-indazole-3- InIn determiningdetermining thethe 20152015 aggregateaggregate Administration,Administration. Department ofof Justice.Justice carboxamidecarboxamide (AB-CHMINACA),(AB-CHMINACA),N-(i- N-(1- productionproduction quotasquotas forfor N-(l-amino-3-N-(1-amino-3- action: ALMON: Final order.order. amino-3-methyl-l-oxobutan-2-yl)-l-emino-3-rtlethy1-1-oxobutan-2-y1)-1- metliyl-l-oxobutan-2-yl)-i-methy1-1-oxobutan-2-y1).1- pentyl-lH-indazoIo-3-carboxamfdepenty1-1H-indazOle-3-carboxamide (AB-(AR- (cyclohexylmethylk1H-indazole-3- SUMMARY:SUMMARY: ThisThis finalfinalorder order establishesestablishes (cycIohexyImethyJ)-lH-indazole-3- PINACA),PINACA), andand (l-(S-fluoropentyl)-lH-kld5-fIuoropentyI)-1H- carboxamidecarboxamide (AB-CHMINACA).(AB-CHMINAGA). N-(1- thethe initialinitial 20152015 aggregateaggregate productionproduction N-(l- indazol-3-yl)(naphthalen-l-indazoL-3-yII(naphthalen.1• amino-3-methyl-l-oxobutan-2-yl]-l-amino-3-methy1-1-oxobutan-211)-1- quotasquotas forfor threethree temporarilytemporarily controlledcontrolled yfimethanoneyfirnethanone (THJ-2201).(TH).2201), intointo scheduleschedule pentyl-lH-indazole-3-carboxamidepenty1-1H-indazole.3-earboxamide (AB- syntheticsynthetic cannabinoids;cannabinoids:11-(1-amino-3-N-(l-amino-3- (AB- II ofofthe the CSACSA (80(80 FRFR 5042),5042), makingmakingall all PINACA),PINACA), and 11.(5-f1uoropentyI]-lH- methyl-l-oxobutan-2-yl]-l-methyl-1-oxobutan-2-y1]-1- and |l-(S-fluoropentyl]-lH- regulatoryregulatory controlscontrols pertainingpertainingto to inda2o1-3-y1I(naphthalen--l- (cyclohexylmethyl)-iH-indazole-3-(cyclohexylmethylk1H-indazole-3- indazol-3-yl](naphthiilen-l- scheduleschedule II controlledcontrolled substances yl)melhanoneylimethanone (THJ-2201),(TH1-2201). thethe DEADEA hashas carboxamidecarboxamide (AB-CHMINACA).(ARCHMINACA). N-(l-N- (1- applicable toto AB-CHMINACA,AB-CHMINACA, AB-AB- taken Into consideration the factors set amino-3-methyl-i-oxobutan-2-yl)-l-amino-3-methy1-1-oxobutan-2.y1).1. taken into consideration the factors set PINACA,PINACA. and THJ-2201.THl-220 5111,bincludingisntcallu ng thethe forthforth at 21 CFR 1303.11, pursuant to 21 pentyl-lH-indazole-3-carboxamidopenty1.1H.indazole-3-earboxamide (AB- pursuant to 21 requirementrequirement toto obtain aa manufacturing U.S.C. 826(a), and other relevant factors, PINACA),PINACA). and [l-(5-fluoropentyl)-lH-11-(5-fluoropentyl)-1H- 826(a), and other relevant factors, quotaquota pursuant toto 21 CFR part 1303. including 2015 export requirements, lndazol-3-yll(naphtbalen-l-Indazol-3-yll(naphthalen.1. including 2015 export requirements, The 2015 aggregate production quotas industrial use, applications for quotas. yljmethanoneyfirnethanone (THJ-2201).(THJ-2201). production quotas industrial use, applications for quotas, forfor AB-CHMINACA.AB-CHMINACA. AB-PINACA,AB-PINACA, andend asas wellwell asas informationinformation onon researchresearch andand DATES: Effective JuneJune 17. 2015. C 17, 2015. THJ-2201THJ-2201 representrepresent thosethose quantitiesquantities thatthat productproduct developmentdevelopment requirements.requirements. forFOR furtherFURTHER informationINFORMATION contact:CONTACT: JohnJohn raaymay bebe manufactured inin thethe United Pursuant toto 2121 U.S.C. 626626 andand inin R. Scherbenske.Scherbonske. OfficeOffice ofofDiversion StatesStates inin 20120155 toto provide forfor thethe" accordanceaccordance withwith 2121CFR CFR 1303.11, thethe Control.Control. Drug Enforcement estimatedestimated scientific,scientific, research,research, andand ActingActing AdministratorAdministrator hereby establishesestablishes 6701 Administration;Administration; Mailing Address:Address: 8701 industrialindustrial needs ofof thethe United States,States, thethe 20152015 aggregateaggregate production quotasquotas forfor Morrissetta Drive, Springfield. Virginia-Virginia- lawful export requirements, and thethe AB-CHMINACA, AB-PINACA. and THJ-TI-11- 22152; Telephone: (202) 508-6812.598-6612. establishment and maintenance of 2201, expressed in grams of anhydrous SUPPLEMENTARY INFORMATION: reserve stocks. acid or base, as follows:follows: Established Basic class—class—scheduleschedule I 2015 quota (9)(el N-(1-amlrw-3-meihyl-1-oxobutan-2-yl)-1-(cyclohexy!nnethy|)-iH-lrdazole-3-eart)oxamltie1)1-(1-amino-3-rnethyl-1-exobutan-211)-1-(eyelehexylmethyl)-1(1.1ndazole.3.carboxamIde (AB-CHMINACA)(AB-CHMINACA) 15 N-(1-amino-3-methyMN-(1-amino.3.methyl-l-exobutan-219-1.penty1-1H-Indazole.3.carboxamiCe-oxobutari-2-yl)-1-penlyl-1 H-inda2o!e-3-carboxamlde (AB-PINACA)(AB-PINACA) 15 (l-(5-tluoropeatyi)-1H-indazoi-3-yl](naphthalen-l-yl]methanone(11541uoropenty8-1Hdridazol.3-yll(naphthalen.1-yllrnethenorie (THJ-2201) 15 InIn accordance with 21 CFR 1303.13. DEPARTMENT OF JUSTICE SUPPLEMENTARY INFORMATION: By notice upon consideration of the relevant dated February 11.11, 2015,2015.andand published Enforcement AdmInistratNn factors,factors. the Acting Administrator may Drug Enforcement Administration in the Federal Register on February 19, adjust the 2015 aggregate production 2015,802015, 80 FR 3902,8902, Mylan Technologies. (Docket[Docket No. DEA-392] quotas for AB-CHMINACA.AB-CHMINACA, AB- Inc.,Inc., 110 Lake Street, Saint Albans, Vermont 05478 applied to be registered PINACA.PINACA, and THJ-2201 as needed. Importer of Controlled Substances as an importer of certain basic classes of Dated:Daled: Junelune 11,11.2015. 2015. Registration: Mylan Technologies, Inc.inc. controlled substances. No comments or Chuck Rosenberg, objections were submitted for this ACTION:action; Notice of registration. objections were submitted for this Acting AdMildS11910t.Administrator. notice. the factors in [FR|FR Dec.Doc. 2015-140052015-14909 Filed 0-10-15:lj-10-15; 8:458:43 am]ami SUMMARY:summary; Mylan Technologies, Inc.Inc. The DEA has considered the factors in applied to be registered as an importer 21 U.S.C. 823, 952(a) and 958(a) and MONOBILLING CODECOOE 44io-tol-li4410-49-f applied to be registered as an importer 21 U.S.C. 823, 962(a) and 958(a) and of certain basic classes of controlled determined that the registrationregistration of substances. The Drug.Drug Enforcement Mylan Technologies, Inc.Inc. to importimport the Administration (DEA](DEA) Grantsgrants Mylan basic classes of controlled substances isis Technologies, Inc.Inc. registrationregistration as an consistent with the public interestinterest and Cc importer of those controlled substances with United States obligations under importer of those controlled substances. with United States obligations under Vol. I PagePage 876876 tUViUIV ' 1 CtQjf FederalFederal Register/Vol.Register/ Vol. BDBO, No.No. 67/Wednesday,67/ Wednesday, AprilApril 6,B, 20152015 /Notices/ Notices 1866718867 COLORADOCOLORADO MecklenburgMackleuburg CountyCounty whichwhich werewere mademade inin FYFY 2014.2014. TheThe inventoryinventory informationinformation is organized by PPark k CCounty unty Oaten,Outen, R.F.,R.F., Pottery.Pottery, 430430 JeffersonJefferson Si..St., is organized by L 15000103 function to show how contracted Matthews,Matthews, 15000183 function to show how contracted TarryallTarryall RuralRural HistoricHistoric Landscape,Landscape, Cty.Cty. Rd.Rd. resourcesresources areare distributeddistributed throughoutthroughout thethe 77.77. MilepostsMiJeposts 2.42.4 toto 41.13.43.8. Jefferson,Jefferson, OHIOOHIO agency.agency. TheThe inventoryinventory has been 1500017015000170 has been HamiltonHamilton CountyCounty developeddeveloped inin accordanceaccordance withwith guidanceguidance SanSan JuanJuan ComityCounty UnitedUnited StatesStates PostPost OfficeOffice andand CourtCourt House,House, issuedissued onon NovemberNovember 5,5, 20102010 byby thethe SoundSound DemocratDemocrat MillMill andand MineMine andand SilverSilver 100100 E.E. 5015th St..St.. Cincinnati.Cincinnati. 1500018415000184 OfficeOffice ofof ManagementManagement andand Budget'sBudget's Office of Federal Procurement Policy QueenQueen Mine.Mine. (Mining(Mining ResourcesResources ofof SanSan OttawaOttawa CountyCounty Office of Federal Procurement Policy JuanJuan County.County, ColoradoColorado MPS)MPS) AddressAddrsss (OFPP).(OFPP). OFPP'sOFPP's guidanceguidance Isis availableavailable atat Perry'sPerry's VictoryVictory andand InternationalInternational PeacePeace Restricted.Restricted. Silverton.Silverton. 1500017115000171 http://invw.whitchouse.govisitesthttp://ivww.ivhitchoijse.gov/siles/ MemorialMemorial (Boundary(Boundary Increase).Increase). 9393 defoulUffies/omb/procuremenilmemo/defoult/files/omb/procurement/mcmo/ MARYLANDMARYLAND ➢elawareDelaware Ave.,Ave., PutPul-in-Bay,-in-Buy, 1500010515000185 service-cone:vet-inventories-guidance-service-controct-inventories'guidance- TENNESSEE BaltimoreBaltimore IndependentIndependent citycity TENNESSEE 1laszoiapdt10520l0.pdf. TheThe FYFY 20142014 inventoryinventory McOonoghMcDonogh PlacePlace HistoricHistoric District,District, N.N. GrundyGrundy CountyCounty plannedplanned analysisanalysis providesprovides informationinformation Broadway, E. Eager, McDonogh & E. Chose on which functional areas will be Broadway, E. Eager, McDonogh & E. Cliuse ChristChrist EpiscopalEpiscopal Church,Church. 530530 10th10th St.,St., TracyTracy on which functional areas will be Sts., Baltimore. 15000172 Sts., Baltimore. 1S000172 City,City. 15000186150001 86 reviewedreviewed byby thethe agency,agency, TheThe UnitedUnited StatesStates InternationalInternational TradeTrade CommissionCommission CharlesCharles CountyCounty • . ShelbyShelby CountyCounty hashas postedposted itsits FYFY 20142014 inventory,inventory. FYFY MallowsMallows Bay—WklewaterBay—Widewaler HistoricHistoric andand One Hundred North Main Building. 100 NI One Hundred North Main Building. 100 N. 20142014 plannedplanned analysis,analysis, andand FYFY 20132013 ArcheologicalArcheological District.District, OffOff CharlesCharles CountyCounty Main SI. Mall Memphis, 15000187 Main SI. Mall, Memphis. 15000187 inventoryinventory analysisanalysis atat thethe followingfollowing link:link: shorelineshoreline atat SandySandy PL.PL. Nenjeraoy,Nanjcmoy, %VESTWEST VIRGINIA littp://www.usitc.gov/procurementihttp://www.usitc.gov/procurement/. 1560017315000173 VIRGINIA FORFOR FURTHERFURTHER INFORMATIONINFORMATION CONTACT:CONTACT: MISSOURI MarionMarion CountyCuunty MISSOURI . QuestionsQuestions regardingregarding thetho serviceservice contractcontract DunbarDunbar School,School, 103103 HighHigh St.,St.. Fairmont,Fairmont, St.St. LouisLouis IndependentIndependent citycity ' 15000188 inventoryinventory shouldshould bebe directeddirected toto DebraDcbra 15000188 Bridge. U.S. International Trade WoodwardWoodward andand TiermanTierman PrintingPrinting CompanyCompany Bridge, U.S. International Trade WISCONSINWISCONSIN Commission, Office of Procurement, 500 Building,Building. 15191519 TowerTower GroveGrove Ave.,Ave., St.St. Commission, Office of Procurement, 500 Louis.Louis, 1500017415000174 SheboyganSheboygan CountyCounty EE StreetStreet SW..SW., Washington,Washington, DCDC 20436,2043G, oror at 202-205-2009 or Prange, Eliza. House. 605 Erie Ave., at 202-205-2004 ordebrabridgeedebra.br/dge® • NEWNEW HAMPSHIREHAMPSHIRE Prange, Eliza. House, 605 Erie Ave., usitc,gote, Sheboygan,Sheboygan, 1500010915OOO109 usilc.gov. Cans County Cnos County ByBy orderorder ofof thethe Commission.Commission. WYOMINGWYOMING Burgess,Burgess, GeorgeGeorge E.,E,. Schuol—NotreSchool—Notre DameDame Dated:Dated: AprilApril 3.3. 2015.2015. Schol, 411 School St., Berlin, TetonTeton CountyCounty HighHigh Schal, 411 School St., Berlin, LisaLisa R.R. Barton,Barton, 1500017515000175 Haldeman Barns, 5460 W. WY 22, Wilson, c Hardeman Barns, 5450 W. WY 22, Wilson, SecretarySecretory toto thethe Commission.Commission. 1500019015000190 NEWNEW JERSEYJERSEY IFRIFR Doc.Dor, 2015-08950201S-08050 FiledFiled 4-7-15;8:454-7-15; 8:45 amiam! BILLING 000E 7020-02-P SussexSussex CountyCounty (FR(FR DocDdc. 2015-080072015-08007 FiledFiled 4-7-15:8:454-7-15: S:4S mutam) BILLING CODE 702O-OS-P B10.810 000E 4312-81-P WaterlooWaterloo VillageVillage (Boundary(Soundary Increase),Increase), BILLING CODE 4312-51-P MusconetcongMusconetcong ItR. && Cty.Cty. Rd.Rd. 604.604. EyramByram DEPARTMENTOEPARTMENTOF OF JUSTICE Township,Township, 1500017615000176 JUSTICE INTERNATIONALINTERNATIONAL TRADETRADE NEWNEW YORKYORK DrugDrug EnforcementEnforcement AdministrationAdministration COMMISSIONCOMMISSION BrunsBrunx CountyCounty [Docket[Docket No.No; DEA-411N1OEA-411N] Availability of FY 2013 Service CrotanaCroiona PlayPlay Center, 1700 Fulton Ave., PublicPublic Availability of FY 2013 Service Center, 1700 Fullcn Ave., Analysis, FY 2014 Controlled Substances: Proposed Bronx,Bronx, 15000177150C0177 ContractContract InventoryInventory Analysis, FY 2014 Controlled Substances: Proposed ServiceService ContractContract inventory,Inventory, andand FYFY AdjustmentsAdjustments tOto thethe AggregateAggregate SuffolkSuffolk CountyCounty 20142014 ServiceService ContractContract InventoryInventory ProductionProduction QuotasQuotas forfor Dllenoxin,Dlfenoxln, SylvesterSylvester Manor,Manor, 8080 N.N. FerryFerry Rd.,Rd., ShelterShelter PlannedPlanned AnalysisAnalysis DiphenoxylateDiphenoxylate (for(for conversion),conversion], andand Island.Island, 1500017815000178 MarijuanaMarijuana AGENCY:AGENCY: U.S.U.S. InternationalInternational TradeTrade NORTHNORTH CAROLINACAROLINA Commission.Commission. AGENCY:AGENCY: DrugDrug EnforcementEnforcement Administration, Department of Justice. AsheAshe CountyCounty . ACTION:action: Notice.Notice. Administration, Department of Justice. ACTION: Notice with request for Ash° County Memorial hospital, (Ashe ACTION: Notice with request for Ashs County Memorial Hospital. (Ashe SUMMARY:SUMMARY: InIn accordanceaccordance withwith SectionSection comments. County.County. NorthNorth Carolina,Carolina, c.c. 1799-19551799-1955 comments. 743743 ofof DivisionDivision CC ofof thethe ConsolidatedConsolidated MPS)MPS) 410410 McConnellMcConnell St..St.. Jefferson,Jefferson, AppropriationsAppropriations ActAct ofof 20102010 (Pub.[Pub. L.L. SUMMARY:SUMMARY: TheThe DrugDrug EnforcementEnforcement -" 10000170150D0176 111-117),111-117), thetho U.S.U.S. InternationalInternational TradeTrade AdministrationAdministration isis proposingproposing toto adjustadjust BeaufortBeaufort CountyCounty CommissionCommission isis publishingpublishing thisthis noticenotice toto thethe establishedestablished 20152013 aggregateaggregate production quota for difenoxin, BelhavenBcihaven CommercialCommercial HistoricHistoric District,District, 260-260 adviseadviss thethe publicpublic ofof thetho availabilityavailability ofof production quota for difenoxin, 292292 E.E. MainMain && 246-288,246-288, 251-229251-279 PamlicoPamlico thethe FYFY 20132013 ServiceService ContractContract InventoryInventory diphenoxylatediphenoxylate (for(for conversion),conversion), andand Sts.,Sts.. Belhaven,Belhaven, 1500016015000180 Analysis,Analysis, thethe FYFY 20142014 ServiceService ContractContract marijuanamarijuana whichwhich areare scheduleschedule II andand IIII Inventory, and the FY 2014 Service controlledcontrolled substancessubstances underunder thethe GuilfordGuilford CountyCounty Inventory, and the FY 2014 Service ContractContract InventoryInventory PlannedPlanned Analysis.Analysis. ControlledControlled SubstancesSubstances Act.Act. Willis.Willis, lamesfames H.H. andand AnneAnnB B., House, 707 B., House. 70" The FYFY 2013 inventoryinventory analysisanalysis DATES:dates: InterestedInterested personspersons maymay fifilele BlairBlair St., Greensboro, 1500010115000181 providesprovides informationinformation on specific serviceservice writtenWritten comments on thisthis noticenotice inin HarnettHarnett CountyCounty contractcontract actionsactions thatthat werewere analyzedanalyzed asas accordanceaccordance withwith 2121 CFRCFR 1303.13,1303.13. the FY 2013 Inventory. The 2014 Electronic comments must be ErwinErwin CommercialCommercial HistoricHistoric District,District, 100too partpart ofof the FY 2013 inventory. The 2014 Electronic comments must be ➢enimDenim ➢rive,Drivo. 101-127101-127 E.E. HH && 103-111103-111 S.S. inventoryinventory providesprovides informationinformation onon submitted,submitted, andand writtenwritten commentscomments mustmust L 13th Sts., Erwin, 15000162 serviceservice contract actions over $25,000 be postmarked, on or before May G. 13th Sts.. Erwin, 15000102 contract actions over $25,000 be postmarked, on or before May 8, Vol. I PagePage 877877 1886818868 FederalFederal Register/Vol.Register/Vol. 80,00, No.No. 6767/Wednesday, /Wednesday, AprilApril 8,8, 20152015 // NoticesNotices 2015.2015. CommentersCommenters shouldshould bebe awareaware thatthat INFORMATION"INFORMATION" inin thethe firstfirst paragraphparagraph forfor eacheach basicbasic classclass ofof controlledcontrolled L thethe electronicelectronic FederalFederal DocketDocket ofof youryour comment.comment. YouYou mustmust alsoalso placeplace substancesubstance listedlisted inin schedulesschedules II andand IIII ManagementManagement SystemSystem willwill notnot acceptaccept allall thetho personalpersonal identifyingidentifying informationinformation eacheach year.year. TheThe AttorneyAttorney GeneralGeneral hashas commentscomments afterafter 11:5911:59 pm.p.m. EasternEastern TimeTime youyou dodo notnot wantwant mademade publiclypublicly delegateddelegated thisthis functionfunction toto thethe onon thethe lastlast dayday ofof thethe commentcomment period.period. availableavailable inin thethe fifirstrst paragraphparagraph ofof youryour AdministratorAdministrator ofof thethe DEA.DEA, 2828 CFRCFR ADDRESSES:addresses: ToTo ensureensure properproper handlinghandling commentcomment andand identifyidentify whatwhat informationinformation 0.100.0.100.lOa. youyou wantwant redacted.redacted. ofof comments,comments, pleaseplease referencereference "Docket"Docket BackgroundBackground No.No. DEA-411N"DEA-411N" onon allall correspondence.correspondence, IfIf youyou wantwant toto submitsubmit confidentialconfidential initial 2015 includingincluding anyany attachments.attachments. TheThe DrugDrug businessbusiness informationinformation asas partpart ofof youryour TheThe DEADEA establishedestablished thethe initial 2015 EnforcementEnforcement AdministrationAdministration encouragesencourages comment,comment, butbut dodo notnot wantwant itit toto bebe mademade aggregateaggregate productionproduction quotasquotas andand thatthat allall commentscomments hebe submittedsubmitted publiclypublicly available,available, youyou mustmust includeinclude thethe assessmentsassessments ofof annualannual needneed anon electronicallyelectronically throughthrough thethe FederalFederal phrasephrase "CONFIDENTIAL"CONFIDENTIAL BUSINESSBUSINESS SeptemberSeptember 8.8, 20142014 (79[79 FRFR 53216).S3216). ThatThat eRulemakingeRulemaking PortalPortal whichwhich providesprovides thethe INFORMATION"INFORMATION" inin thethe firstfirst paragraphparagraph noticenotice stipulatedstipulated that,that, asas providedprovided forfor Inin abilityability toto typetype shortshort commentscomments directlyditectly •' ofof youryour. comment.comment. YouYou^ mustmust alsoalso_ 2121 CFRCFR 1303.13,1303.13. allall aggregateaggregate intointo thethe commentcomment fifieldeld onon thethe WebWeb pagepage prominentlyprominently identifyidentify confidentialconfidential productionproduction quotasquotas andand assessmentsassessments ofof oror attachattach aa filefile forfor lengthierlengthier comments.comments. businessbusiness informationinformation toto bebe redactedredacted annualannual needneed areare subjectsubject toto adjustment.adjustment. PleasePlease gogo toto http://www.regulations.govhttp://www.regulations.gov withinwithin thethe comment.comment, BasedBased onon unanticipatedunanticipated medical,medical, andand fallowfollow thethe onlineonline instructionsinstructions atat CommentsComments containingContaining personalpersonal scientific,scientific, research,research, andand industrialindustrial needsneeds thatthat sitesite forfor submittingsubmitting comments.comments. UponUpon identifyingidentifying informationinformation andand confidentialconfidential ofof thethe UnitedUnited StatesStates thetha DEADEA proposesproposes completioncompletion ofof youryour submissionsubmission youyou willwill businessbusiness informationinformation identifiedidentified andand toto adjustadjust thethe establishedestablished 20152015 aggregateaggregate receivereceive aa CommentComment TrackingTracking NumberNumber forfor located'oca,ed as39 directeddirected aboveabove willwill generallygenerally productionproduction quotasquotas forfor thethe scheduleschedule I1 andand II controlled substances difenoxin, youryour comment.comment. PleasePlease bebe awareaware thatthat bebe mademade availableavailable inin redactedredacted form.form. IfIf aa II controlled substances difenoxin, commentcomment haslias soso muchmuch confidentialconfidential diphenoxylatodiphenoxylate (for(for conversion),conversion), andand submittedsubmitted commentscomments areare notnot marijuana to be manufactured in the instantaneouslyinstantaneously availableavailable forfor publicpublic businessbusiness informationinformation oror personalpersonal marijuana to be manufactured in the identifying information cannot bebe UnitedUnited StatesStates inin 2015.2015. TheThe adjustmentadjustment viewview onon Regulations.gov.Regulations.gov. IfIf youyou havehave identifying information thatthat itit cannot effectively redacted,allall oror partpart ofof thatthat isis necessarynecessary toto provideprovide forfor thethe estimatedestimated receivedreceived aa CommentComment TrackingTracking Number,Number, effectively redacted, comment may not be made publicly medical,medical, scientific,scientific, research.research, andand youryour commentcomment hashas beenbeen successfullysuccessfully comment may not be made publicly available. Comments posted to littp:// industrial needsneeds ofof thethe UnitedUnited States.States. submittedsubmitted andand therethere isis nono needneed toto available. Comments posted to bttp:// industrial www.regulations.govwww.teguIations.gov maymay includeinclude anyany lawfullawful exportexport requirements,requirements, andand thethe resubmitresubmit thethe samesame comment.comment. PaperPaper personalpersonal identifyingidentifying informationinformation (such(such establishmentestablishment andand maintenancemaintenance ofof commentscomments thatthat duplicateduplicate electronicelectronic asas name,name, address,address, andand phonephone number) reservereserve stocks.stocks. _ submissionssubmissions areare notnot necessarynecessary endand areare number) includedincluded inin thethe texttext ofof youryour electronicelectronic InIn proposingproposing thethe adjustment,adjustment, thethe discouraged.discouraged. ShouldShould youyou wishwish toto mailmail aa submission that is not Identified as AdministratorAdministrator hashas takentaken intointo accountaccount paperpaper commentcomment inin lieulie u ofof anan electronicelectronic submission that is not identified as directed above as confidential. the>ho followingfollowing criteriacriteria inin accordanceaccordance comment,comment, itit shouldshould bebe sentsent viavia regularregular directed above as confidential. AnAn electronicelectronic copycopy ofof thisthis documentdocument withwith 2121 CFRCFR 1303.13:1303.13: (1)(1) ChangesChanges inin c oror expressexpress mailmail to:to: DrugDrug EnforcementEnforcement isis availableavailable atat http://http:// demanddemand forfor thethe basicbasic class.class, changeschanges inin Administration, Attention: DEADEA Federal www.regulations.gov forfor easyeasy reference.reference, thethe national raterate of net disposal forfor thethe 8701 Register Representative/ODXL,Representative/ODXL. 8701 , ...... class,class, andand changeschanges inin thethe raterate ofof netnet MorrissetteMorrissette Drive,Drive, Springfield,Springfield, VirginiaVirginia LegalLegal AuthorityAuthority disposaldisposal byby thethe registrantsregistrants holdingholding 22152.22152. TheThe DrugDrug EnforcementEnforcement individualindividual manufacturingmanufacturing quotasquotas forfor thethe FORFOR FURTHERFURTHER INFORMATIONINFORMATION CONTACT:CONTACT: AdministrationAdministration (DEA)(DEA) implementsimplements andand class;class; (2)(2) whetherwhether anyany increasedincreased demanddemand ImeldaImelda L. Paredes.Paredcs, Office of Diversion enforcesenforces titlestitles IIIT andand IIIIff of thethe oror changeschanges. inin thethe nationaland/ornational and/or Control, Drug Enforcement ComprehensiveComprehensive Drug Abuse Prevention individualindividual ratesrates of net disposaldisposal arcare Administration; Mailing Address: 87018701 andand ControlControl Act ofof 1970,1970, asas amended.amended. 2121 temporary,temporary, shortshort term,term, oror longlong term;term; (3)(3) MorrissetteMorrissette Drive.Drive. Springfield,Springfield. VirginiaVirginia U.S.C.U.S.C. 801-971.601-971, TitlesTitles IIII andand IIIHi areare whetherwhether anyany increasedincreased demanddemand forfor thatthat 22152,22152, TelephoneTelephone (202)(202) 598-6612.590-6812. referredreferred toto asas thethe "Controlled"Controlled classclass cancan bebe metmet throughthrough existingexisting SUPPLEMENTARYSUPPLEMENTARY INFORMATION:INFORMATION: SubstancesSubstances Act" andand thethe "Controlled"Controlled inventories,inventories, increasedincreased individualindividual SubstancesSubstances ImportImport andand Export Act," manufacturing quotas,quotas, oror increasedincreased Posting of Public CommentsComments Posting of Public respectively,respectively, andend areare collectivelycollectively importation,importation, without increasingincreasing thethe Please note thatthat allall commentscomments referredreferred toto asas thethe "Controlled"Controlled aggregateaggregate production quota;quota; (4)(4) whether receivedreceived Inin responseresponse toto thisthis docketdocket areare SubstancesSubstances Act" oror thethe "CSA""CSA" forfor thethe anyany decreaseddecreased demanddemand will resultresult inin consideredconsidorcd part ofof thethe public record.record. purpose ofof thisthis action.action. The DEA excessiveexcessive inventoryinventory accumulationaccumulation by allall They will, unless reasonablereasonable causecause isis publishes thethe implementingimplementing regulationsregulations persons registeredregistered toto handle thethe class;class; given,given, be made availableavailable by thethe Drug forfor thesethese statutesstatutes inin titletitle 2121 ofof thethe CodeCode andand (5)(5) otherother factorsfactors affectingaffecting thethe Enforcement Administration forfor public ofof Federal Regulations (CFR),(CFR). chapterchapter II.II. medical, scientific,scientific, research.research, andand inspectioninspection online at http://http:/l The CSACSA and itsits implementingimplementing industrialindustrial needs ofof thethe United StatesStates www.regulations.gov.www.i-egubtions.gov. Such informationinformation regulations are designed to prevent, and lawfullawful export requirements, as the includesincludes personal identifyingidentifying detect,detect, andand eliminateeliminate thethe diversiondiversion ofof Administrator findsfinds relevant.relevant. informationinformation (such(such asas youryour name, controlledcontrolled substancessubstances andand listedlisted Analysis forfor Adjusting thethe Established address,address, etc.)eic.) voluntarily submittedsubmitted byby chemicalschemicals intointo thethe illicitillicit market whilewhile 2015201S Aggregate Production QuotaQuota forfor thethe commenter. TheTho Freedom ofof providing for thethe legitimatelegitimate medical, Difenoxin and Diphenoxylate (for(for Informationinformation Act applies to all comments scientific, research.research, and industrialindustrial needs Conversion) received. If you want to submitsubmit personal of the United States. Controlled identifyingidentifying informationinformation (such(such as your substancessubstances have the potential for abuse Since thetho establishment of the initialinitial name,name, address.adtfress, etc.)etc.) asas part ofof youryour andand dependencedependence andand areare controlledcontrolled toto 20152015 aggregateaggregate production quotas,quotas, thethe comment, butbut do not wantwant itit toto bebe protect theIke public healthhealth and safety.safety. DEADEA has receivedreceived requestsrequests fromfrom DEADEA posted online or made available inin thethe Section 306 of thetho CSA (21(21 U.S.C. registered manufacturers toto manufacture c public docket, you must includeinclude thethe 626)826) requires thethe Attorney General toto difenoxin and diphenoxylate (for(for phrase "PERSONAL"PERSONAL IDENTIFYINGIDENTIFYING establish aggregate production quotas conversion) toto supportsupport thethe manufacture Vol. I Page 878 / FederalFederal Register/Vol.Register/ Vol. 80,80, No,No, 6767/Wednesday, /Wednesday, AprilApril 8,8, 20152015/Notices /Notices 1886918869 ofof prescriptionprescription drugdrug productsproducts approvedapproved Dated:Dated: AprilApril 1,t, 20152015.. ChemicalChemical SensorSensor andand SensingSensing MethodMethod c byby thethe FoodFood andand DrugDrug AdministrationAdministration MicheleMlchele M.M, Leonharl.Leonharl, forfor UseUse Therewith,"Therewith," NASANASA CaseCase No.No. (FDA)(FDA] forfor thethe treatmenttreatment ofof chronicchronic Administrator.Administrator. LAR-17579-1;LAR-17579-1; U.S.U.S. PatentPatent ApplicationApplication diarrheadiarrhea andand forfor thethe treatmenttreatment ofof , IraIFR Doc.Doc. 2015-0804221)15-08042 FiledFiled 4-7-15;4-7-15. B:458:45 amlami No.No. 14/215,79314/215,793 titledtitled "Wireless"Wireless diarrheadiarrhea associatedassociated withwith irritableirritable bowelbowel Chemical Sensor and Sensing eu.1.11111BILLING CODEeooe 0410-09-1.4410-C9-P Chemical Sensor and SensingMethodMethod syndromesyndrome (1BS).{IBS/.1 1TheseThese FDAFDA approvedapproved forfor UseUse Therewith,"Therewith," NASANASA CaseCase No.No. productsproducts havehave notnot beenbeen manufacturedmanufactured LAR-17579-2;LAR-17579-2; U.S.U.S. PatentPatent No.No. sincesince 20092009 duedue toto FDAFDA-regulated-regulated 8,167,2048,167,204 B2B2 titledtitled "Wireless"Wireless DamageDamage NATIONALNATIONAL AERONAUTICSAERONAUTICS ANDAND manufacturingmanufacturing issuesissues andand therethere isis nono Location Sensing System," NASA Case SPACESPACE ADMINISTRATIONADMINISTRATION Location Sensing System," NASA Case existingexisting genericgeneric oror therapeutictherapeutic No.No. LAR-17593-1.LAR-17593-1; U.S.U.S. PatentPatent No.No. equivalent.equivalent. (Notice(Notice (15-026)1(15-026)1 8,179,2038,179,203 B2B2 titledtitled "Wireless"Wireless ElectricalElectrical DeviceDevice UsingUsing OpenOpen-Circuit-Circuit ElementsElements AnalysisAnalysis forfor AdjustingAdjusting thethe EstablishedEstablished Not|ee o( |ntent to Grant aPartiallyPartially Notice of Intent To Grant a HavingHaving NoNo ElectricalElectrical Connections,Connections," 20152015 AggregateAggregate ProductionProduction QuotaQuota forfor Exclusive License Exclusive License NASANASA CaseCase No. LAR-17711-1; U.S. MarijuanaMarijuana No. LAR-17711-1: U.S. PatentPatent ApplicationApplication NaNo. 14/193,88114/193,861 titledtitled SinceSince thethe establishmentestablishment ofof thethe initialinitial MaimAGENCY: National Aeronautics and Space Administration.National Aeronautics and "Wireless"Wireless TemperatureTemperature SensingSensing (lavingHaving 20152015 aggregate.productianaggregate.production quotas,quotas, thethe Space Adminis a ion. NoNo ElectricalElectrical ConnectionsConnections andand SensingSensing DEADEA hashas receivedreceived notificationnotiGcation fromfrom DEADEA ACTION:action: NoticeNotice ofoflntent Intent toto GrantGrant Method for Use Therewith," NASA Case Partially Exclusive License. Method for Use Therewith," NASA Case registeredregistered manufacturersmanufacturers thatthat researchresearch Parffaliy Exclusive License, No.No. LAR-17747-1-CON;LAR-17747-1-CON; U.S.U.S. PatentPatent andand productproduct developmentdevelopment involvinginvolving SUMMARY:summary: ThisThis noticenotice isis issuedissued inin ApplicationApplication No.No. 1317913,62813/796,626 fititledlled cannabidiol,cannabidiol, isis increasingincreasing beyondbeyond thatthat accordanceaccordance withwith 3535 U.S.C.U.S.C. 209(e)209(e) andand 3737 "Method"Method ofof MappingMapping AnomaliesAnomalies inin previouslypreviously anticipatedanticipated forfor 2015.2015. TheThe CFR 404.7(a](l)(i). gives . HomogenousHomogenous Material."Material." NASANASA CaseCase No.No. associatedassociated productproduct developmentdevelopment CFR 404.7(e)(1)((). NASANASA herebyhereby gives noticenotice ofof itsits intentintent toto grantgrant aa partiallypartially LA11-17845-1LAR-17848-1 totoGLSEQ, GLSEQ, LLCLLC havinghaving itsits activitiesactivities areare relatedrelated toto processprocess license in the United States to principalprincipal placeplace ofof businessbusiness inin OwensOwens validation and commercialization exclusiveexclusive license in the United States la validation and commercialization CrossCross Roads.Roads. Alabama.Alabama. TheThe fieldsfields ofof useuse activities, including qualification practicepractice thethe inventioninvention describeddescribed andand activities, including qualification claimed in U.S. Patent No. 7.066,593 132 may be limited to, but not necessarily be activitiesactivities relatedrelated toto potentialpotential U.S.U.S. FoodFood claimed in U.S. Patent No. 7,086,593 B2 ' may be limited to, but not necessarily he titled "Magnetic Field Response limited to, safety related and non-safety andand DrugDrug Administration submission titled "Magnetic Field Response limited to. safety related and non-safety Administration submission MeasurementMeasurement AcquisitionAcquisition System,"System," relatedrelated instrumentationinstrumentation andand controlcontrol support.support. LAR-16908-1; U.S. systems for nuclear facilities, including Additionally,Additionally, thethe DEADEA hashas alsoalso NASANASA CaseCase No.No. LAR-16908-1; U.S. systems for nuclear facilities, including 7,159174 advanced safety related and non-safety receivedreceived notificationnotification fromfrom thethe NationalNational PatentPatent No,No 7,159,774B2B2 titledtitled advanced safety related and non-safety Measurement related instrumentation systems for InstituteInstitute onon DrugDrug AbuseAbuse (NIDA)(NIDA) thatthat itit "Magnetic"Magnetic FieldField ResponseResponse Measurement related instrumentation systems for - - severesevere accidentaccident monitoringmonitoring withinwithin requiredrequired additionaladditional suppliessupplies ofof AcquisitionAcquisition System."System." NASANASA CaseCase No.No. nuclearnuclear powerpower plantsplants andand nuclearnuclear marijuanamarijuana toto bebe manufacturedmanufactured inin 20152015 toto LAR-17280-1;LAR-17280-l; U.S.U.S. PatentPatent No.No. Field storagestorage facilities.facilities. TheThe patentpatent rightsrights inin pprovide 'd ffor ongoingng g andand anticipatedanticipated 7,075,295E127,075,295 B2 titledtitled "Magnetic"Magnetic Field L thesethese inventionsinventions havehave beenbeen assignedassigned toto researchresearch effortsefforts involvinginvolving marijuana.marijuana. ResponseResponse SensorSensor forfor ConductiveConductive NASA Case No. thethe UnitedUnited StatesStates ofof AmericaAmerica asas NIDAN3DA isis ae componentcomponent ofof thethe NationalNational Media,"Media," NASA Case No. LAR-16571-1:LAR-16571-l; representedrepresented byby thethe AdministratorAdministrator ofof thethe InstitutesInstitutes ofof HealthHealth andand thethe U.S.U.S. U.S.U.S. PatentPatent No.No. 7,589,5257,589,525 812B2 titledtitled NationalNational AeronauticsAeronautics andand SpaceSpace DepartmentDepartment ofof HealthHealth andand HumanHuman "Magnetic"Magnetic FieldField ResponseResponse SensorSensor forfor NASA Case No, Administration.Administration. TheThe prospectiveprospective ServicesServices whichwhich overseesoversees thethe cultivation.cultivation, ConductiveConductive Media,"Media," NASA Case No, partiallypartially exclusiveexclusive licenselicense willwiil complycomply productionproduction andand distributiondistribution ofof researchresearch-- LAR-16571-2;LAR-16571-2; U.S.U.S. PatentPatent No.No. 7.769.932 B2 titled "Magnetic Field withwith thethe termsterms andand conditionsconditions ofof 3535 gradegrade marijuanamarijuana onon behalfbehalf ofof thethe UnitedUnited 7,759,932 B2 titled "Magnetic Field Conductive U.S.C.U.S.C. 209209 andand 3737 CFRCFR 404.7.404.7. StatesStates Government,Government, pursuantpursuant toto thethe ResponseResponse SensorSensor forfor Conductive LAR-16571-3; SingleSingle ConventionConvention onon NarcoticNarcotic DrugsDrugs Media,"Media," NASANASA CaseCase No.No. LAR-16571-3; DATES:OATEs: TheThe prospectiveprospective partiallypartially 8,430,327 B2 titled (March(March 30,30, 1961,101961, 18 USTUST 1407).1407). U.S.U.S. PatentPatent No.No. 8,430,327 B2 titled exclusiveexclusive licenselicense maymay bebe grantedgranted unless,unless, TheThe Administrator,Administrator, therefore.therefore, "Wireless"Wireless SensingSensing SystemSystem UsingUsing OpenOpen-- withinwithin fiGfteenfteen (15)(15) daysdays fromfrom thethe datedate ofof proposesproposes toto adjustadjust thethe 20152015 aggregateaggregate Circuit,Circuit, ElectricallyElectrically-Conductive-Conductive SpiralSpiral-- thisthis publishedpublished notice,notice, NASANASA receivesreceives productionproduction quotasquotas forfor difenaxin,difenoxin, TraceTrace Sensor,"Sensor," NASANASA CaseCase No.No. LAR-LAR- writtenwritten objectionsobjections includingincluding evidenceevidence diphenoxylatediphenoxylate (for(for conversion),conversion), andand 17294-1;17294-1; U.S.U.S. PatentPatent No.No. 7,683,7977,683,797 B2B2 andand argumentargument thatthat establishestablish thatthat thethe marijuana,marijuana, expressedexpressed inin gramsgrams ofof titledtitled "Damage"Damage Detection/LocatingDetection/Locating grantgrant ofof thethe licenselicense wouldwould notnot bebe anhydrousanhydrous acidacid oror base,base, asas follows:follows: SystemSystem ProvidingProviding ThermalThermal Protection,"Protection," consistentconsistent withwith thethe requirementsrequirements ofof 3535 NASANASA CaseCase No.No. LAR-17295-1;LAR-17295-1; U.S.U.S. U.S.C.U.S.C. 209209 andand 3737 CFRCFR 404.7.404.7. PreviouslyPreviously PatentPatent No.No. 7,902.8157,902.815 B2B2 titledtitled "Wireless"Wireless CompetingCompeting applications completed and BasicBasic (lats.class- AdjustedAdjusted 20152015 applications completed and establishedestablished System and Method for Collecting scheduleschedule I I quotaQuota System and Method for Collecting receivedreceived byby NASANASA withinwithin fifteenfifteen (15)(15) 20152015 quotaquota MotionMotion andand NonNon-Motion-Motion RelatedRelated DataData ofof daysdays ofof thethe datedate ofof thisthis publishedpublished noticenotice aa RotatingRotating System,"System," NASANASA CaseCase No.No, objections to the DifenoxInDifenoxin ... 50SO gg 9,0009,000g 9 willwill alsoalso hehe treatedtreated asas objections to the LAR-17433-1: U.S. Patent No. MarijuanaMarijuana .... 125.000125,000 9g 400,000400,000 g LAR-i 7433-1; U.S. Patent No. grantgrant ofof thethe contemplatedcontemplated partially 8,042,7398.042,739 B2B2 titledtitled "Wireless"Wireless TamperTamper exclusiveexclusive license.license. DetectionDetection SensorSensor andand SensingSensing System,"System," response to Previously ObjectionsObjections submittedsubmitted inin response to BasicBasic class-class- Adjusted 20152015 NASA CaseCase No. LAR-17444-1; U.S. schedule 0 establishedestablished thisthis notice willwill not bebe made availableavailable toto schedule II quotaquota Patent No. 7,711,5097,711,509 112B2 titledtitled "Method"Method 20152015 quotaquota thethe publicpublic forfor inspectioninspection and,and, t0to thethe ofof CalibratingCalibrating aa FluidFluid-Level-Level extentextent permittedpermitted by law,law, willwill not bebe Diphonoxylat- Zero 75,000975,000 g Measurement System,'System," NASA CaseCase No. aphenexYla1- Zero Measurement releasedreleased under thethe Freedom ofof ee (fer(for con-con LAR-17460-1;LAR-l 7480-1; U.S. Patent No. Informationinformation Act,Act. 55 U.S.C. 552.552. version).version). 7,814,7867,814,786 112B2 titledtitled "Wireless"Wireless SensingSensing SystemSystem forfor NonNon-Invasive-Invasive Monitoring ofof ADDRESSES:aodresses: ObjectionsObjections relatingrelating t0to thethe Attributes Ofof ContentsContents inin aa Container,"Container," prospective licenselicense may be submittedsubmitted toto ' silenexinDifenoxin Itchedule(schedule I)I) Isis thethe aoctivo tote U.S. Patent Counsel,Counsel, Office of Chief Counsel. ppharmaceutical arm ' ligingredient d' IIn theh diarrheaea NASA CaseCase No. LAR-17488-1:LAR-17488-1; U.S. Office of Chief Counsel, L Research Center, MS 30, preparationpreparation (soh(schedule dole VlV|. Patent No. 8,673.649E128,673.649 E2 titledtitled "Wireless"Wireless NASA Langley Research Center, MS 30. Vol. I Page 879879 FederalFederal Register/Val.Register/Vol. BO,80, No.No. 116116/Wednesrlay, /Wednesday, luneJune 17,17, 2015/Notices2015/Notices 3469534695 Dated:Dated; JuneJune IL11, 2015.2015. ' BackgroundBackground OnOn MarchMarch 20.20, 2015,2015, thethe DEADEA ChuckChuck Rosenberg,Rosenberg, publishedpublished aa noticenotice titled,titled, "Controlled"Controlled SectionSection 306306 ofof thethe ControlledControlled L AActing t' g Adm"Administrator. rot Substances:Substances: 20152015 ProposedProposed AggregateAggregate L SubstancesSubstances ActAct (GSA)(CSA) (21(21 U.S.C.U.S.C. 826)826) . ProductionProduction QuotasQuotas forfor ThreeThree (FR(Fit DocDoc. 2015-119102011-14910 FiledFiled 6-111-15;B-1&-1S; 8215atel0:45 ami requires Attorney General to requires thethe Attorney General to TemporarilyTemporarily ControlledControlled SyntheticSynthetic BILLINGBILLING CODECODE 4110-09-P4410-09-P establish aggregate production establish aggregate production quotasquotas Cannabinoids"Cannabinoids" inin thethe FederalFederal RegisterRegister forfor eacheach basicbasic classclass ofof controlledcontrolled (80(80 FRFR 15034).15034). ThatThat noticenotice proposedproposed thethe substancesubstance listedlisted inin schedulesschedules II andand IIII DEPARTMENT OF JUSTICE 20152015 aggregateaggregate productionproduction quotasquotas forfor DEPARTMENT OF JUSTICE and for ephedrine, pscudoophedrine, and for ephedrine. pseudoophedrine, AB-CHMINACA,AB-CHMtNACA, AB-PINACA,AB-PINACA, andandTHJ- TIll- andand phenylpropanolamine.phenylpropanolamine. TheThe DrugDrug EnforcementEnforcement AdministrationAdministration 2201.2201. InterestedInterested personspersons werewere invitedinvited toto Attorney has delegated this Attorney GeneralGeneral has delegated this commentcomment onon oror objectobject toto thethe proposedproposed authorityauthority toto thethe AdministratorAdministrator ofof thethe [Docket[Docket No.No. DEA-4109DEA-41 OF) aggregateaggregate productionproduction quotasquotas forfor AB-AB- DEA.DEA. 2828 CFRCFR 0.100(h).0.100(b). CHMINACA,CHMINACA, AB-PINACA,AB-PINACA. andand TH1.THJ- f OnOn JanuaryJanuary 30,30, 2015,2015. thethe DEADEA 22012201 onon oror beforebefore AprilApril 20,20, 2015.2035. NoNo publishedublished inin thethe FederalFederal RegisterRegister aa finalfinal commentscomments werewere received.received. 4 rorderorder toto temporarilytemporarily placeplace threethree .^yntheticsnthetic cannabinoids,N-(1-amino.3.cannabinoids, N-(i-amino-3- AnalysisAnalysis forfor 20152015 EstablishedEstablished AggregateAggregate "methyl-methy1-1-axobutan-2-y1)-1-l-oxobutan-2-yl)-l- ProductionProduction QuotasQuotas AGENCY:agency: DrugDrug EnforcementEnforcement (cyclohoxylmethylk1H-indazole-3-(cyclohoxylmethyl)-lH-indazole-3- InIn determiningdetermining thethe 20152015 aggregateaggregate Administration,Administration, DepartmentDepartment ofof Justice.Justice, carboxamidecarboxamide (AB-CHMINACA),(AB-CHMINACA), N.(1-N-(l- productionproduction quotasquotas forfor N.(1-amino-3-N-(l-amino-3- ACTION:ACTION; FinalFinal order.order. amino-3-rnethy1-1.oxobutan-2-yfiamino-3-methyM-oxobutan-2-yl]-l- -1- mathyl-Fuxobutan-2-31)-1-methyl-l-oxobutan-2-yIl-l- . pentyl-th-indazole-3-carboxamidepentyl-lH-indazole-3-carboxamide (AR(AB- (cyclohexylmethyl)-1H-indazole-3-(cyclohexylmethyl).lH-indazolc-3- SUMMARY:SUMMary: ThisThis fifinalnal orderorder establishesestablishes £IN/CA), and [Ms-fluoropentyU-lH- PINACA), end (1-(5-fluoropenty1).1H. carboxamidecarboxamide (AB-CHMINACA),(AB-CHMINACA), N-(1.N-(i- thethe initialinitial 20152015 aggregateaggregate productionproduction indazol-3.yl|(naphthalen-l- indazol-3-ylfinaphthalen-1- annno-3-methyl-1-oxobutan-2-yI)-1-amino-3-methyl-l-oxobutan-2-yl)-l- quotasquotas forfor threethree temporarilytemporarily controlledcontrolled yl)methanone (THJ-2201), into schedule yfirnethanone (TIIJ-2201), into schedule penty1-111-Indazole.3-cuboxamidepentyl-lH-indazole-3-carboxamide (AB-(AB- syntheticsynthetic cannabinoids:N-(1-amine-3-cannabinoids: N-(l-amino-3- [of(he CSA [80 FR 5042)i makillg all I of the CSA (80 FR 5042), making all PINACA),PINACA), andand (1-(5-fluoropentyI)-1H-[l-(5-fluoropentyl)-lH- methyl-1-oxobutan-2-y1)-1-methyl-l-oxobutan-2-yl)-l- regulatory controls pertaining to . regulatory controls pertaining to indazol-3-ylJ(naphthalen-l- (cyclohexylmethyl)-1H-indazole-3-(cyclohexyImethyI)-lH;.ndazo e-3- sc£cduleI controlled substances schedule I controlled substances yfimethanoneyljmethanone (TH1-2201),(THJ-2201), thethe DEADEA has"has" carboxamidecarboxamide (AB-CHMINACA),(AB-CHMINACA), N-(1-N-(l- applicable to AB-CHMINACA, AB- applicable to AB-CHMINACA, AB- takentaken intointo considerationconsideration thethe factors set amino-3-mothyl-1-exobutan-2.yl)-1.amino-3-mothyl-l-oxobutan.2.yl)-l- factors set PINACA,pjnaca, andand THJ-2201.THJ-2201, Includingincluding thethe pursuant to 21 I penty1-111-indazole-3-carboxamide (AB- forthforth atat 2121 CFRCFR 1303.11,1303.11, pursuant to 21 r«"Carh0Xamn B' requirementrequirement toto obtainobtain aa manufacturingmanufacturing U.S.C.U.S.C. 826(a),826(a), andend otherother relevantrelevant factors,factors, PINACA),PINACA), andand 11-(5.fluorapentyl)-1H-[l.(5.fluoropenty])-lH- quotaMota pursuantpursuantt0 to 2121 CFRCFR partpart 1303,1303, requirements, indazol.3-yll(naphthaIen-1. includingincluding 20152015 exportexport requirements, The 2015 aggregate production quotas industrialindustrial Use,use, applicationsapplications forfor quotas,quotas, yfimethanoneyDmethanone (TH1-2201).(THJ-2201). 'forTheAB-CHMINACA,2015 aggregateAB-PINACA.production quotasand for AB-CHMINACA, AB-PINACA, and asas wellwell asas informationinformation onon researchresearch andand DATES:DATES: EffectiveEffective JuneJune 17,17, 2015.2015. TH1-2201THJ-2201 representrepresent thosethose quantitiesquantities thatthat productproduct developmentdevelopment requirements.requirements. L FOR FURTHER information contact: John may L FOR FURTHER INFORMATION CONTACT: John be manufactured in thoUnitedUnited PursuantPursuant toto 2121 U.S.G.U.S.C. 826826 andand inin may be manufactured in the KR. Scherbenske,Scherbenske, OfficeOffice ofof DiversionDiversion StatesStates inin 2015201 5 toto provideprovide forfor thethe accordanceaccordance with 2121 CFRCFR 1303.11,1303.11, thethe Control,Control, DrugDrug EnforcementEnforcement estimatedestimated scientific,scientific, research,research, andand ActingActing AdministratorAdministrator herebyhereby establishesestablishes Administration:MailingAdministration; Mailing Address:Address; 87018701 industrialindustrial needsneeds ofof thethe UnitedUnited Stales,States, thethe 20152015 aggregateaggregate productionproduction quotasquotas forfor MortissatteMorrissotte Drive,Drive, Springfield,Springfield, VirginiaVirginia lawfullawful exportexport requirements,requirements, andand thethe AB-CHMINACA.AB-CHMINACA. AB-FINACA,AB-PINACA, andand TH1.THJ- 22152;22152; Telephone: (202)(202) 5O8-6812.598-6812. establishmentestablishment andand maintenancemaintenance ofof 2201,2201 , expressedexpressed inin gramsgrams ofof anhydrousanhydrous SUPPLEMENTARYSUPPLEMENTARY INEORMADONIINFORMATION: reservereserve stocks.stocks. acidacid oror base.base, asas follows:follows: EstablishedEstablished BasicBasic classclass—schedule—schedule II 20152015 quotaquota (9)(9) N-(1-amino-3-methyl-1-oxabutan-211)-11cyclohexylmethyl)-1H-Indazole-3-carboxamideN-(T-amirio-3-fretfiyf-l-<3>MDufati-2-y!)-t-(cyctoftexyknethyi)-tH-indazole-3-ca'be>xamWe (AB-CHMINACA)(AB-CHMINACA) 1515 N-(1-amino-3.methy1-1-exobutan-210-1-pentyi-114.1ndazole-3-carboxamIdeN-(l-arriino-3-methyl-1-oxobutan-2-yl)-l-pemyl-1H-lndazo1e-3-carboxamlde (AB-PINACA)(AB-PINACA) 1515 11-(5-11uoropenly1)-1H.indaw1-311(naphtnalen.111)methanonoll-(5-llLoropenlyl)-lH-indazol-3-yi](naphthalen-l-yl)methanono (THJ-2201)(THJ-2201) 1515 InIn accordanceaccordance withwith 2121 CFRCFR 1303.13,1303.13, DEPARTMENTDEPARTMENT OFOF JUSTICEJUSTICE SUPPLEMENTARYSUPPLEMENTARY INFORMATION:INFORMATION! ByBy noticenotice uponupon considerationconsideration ofof thethe relevantrelevant dateddated FebruaryFebruary 11,11, 2015,2015, andand publishedpublished factors,factors, thethe Acting Administrator maymay Drugrug EnforcementEnforcement Administration inin thethe FederalFederal RegisterRegister on FebruaryFebruary 19.19, adjust thetho 2015 aggregate production 2015, 80 FRFR 8002,8902, MylanMylan Technologies, [Docket[Oocket No.No. DEA-392]DEA-392] quotas forfor AB-CHMINACA, AB- Inc.,Inc., 110110 LakeLake Street, Saint Albans, Vermont 05478 appliedapplied toto hebe registeredregistered PINACA,PINACA, andand THJ-2201THJ-2201 asas needed.needed. ImporterImporter ofof ControlledControlled SubstancesSubstances asas anan importerimporter ofof certaincertain basicbasic classesclasses ofof Registration:Registration: MylanMylan Technologies,Technologies, Inc.Inc. Dated:Dated: luneJune 11.11, 2015.2015. controlledcontrolled substances.substances. NoNo commentscomments oror ChuckChuck Rosenberg,Rosenberg, ACTION: NoticeNotice ofof registration.registration. objectionsobjections wore submittedsubmitted forfor thisthis Acting Administrator. notice.notice. IFRIFRDoe. Doc. 2015-14E092015-14909 FiledFilod 66-16-15:8:45-10-IS: 8:45 anilami SUMMARY: MylanMylan Technologies, Inc.Inc. The DEADEA hashas considered the factorsfactors inin importer 21 U.S.C. 823, 952(a) and 958(a) and BILLINGBELLING CODE 41104410-09-P-C9-P applied to be registeredregistered as an importer 21 U.S.C. 823, 952(a) and 958(a) and ofof certaincertain basicbasic classesclasses ofof controlledcontrolled determineddetermined thatthat thethe registrationregistration ofof substances.substances. The DrugDrug EnforcementEnforcement MylanMylan Technologies, Inc.Inc. toto Importimport thethe Administration (DEA)(DEA) grantsgrants MylanMylan basicbasic classesclasses ofof controlledcontrolled substancessubstances isis Technologies, Inc.Inc. registrationregistration asas anan consistentconsistent with thethe publicpublic interestinterest andand LL importerimporter of those controlled substances. with UnitedUnited States obligations under Vol. I PagePage 880 4 « .vsaaad? H9«vw 'J oojr 1503415034 FederalFederal Register/Vol.Register/ Vol, 80,80, No.No. 54/Friday,54/Friday, MarchMarch 20,20, 20152015/Notices /Notices TheThe publicationpublication ofof thisthis noticenotice opensopens PINACA),PINACA), andand {145-BuoropentyB-1H-{l-(5-fluocopentyl)-lH- instantaneouslyinstantaneously availableavailable forfor publicpublic L aa periodperiod forfor publicpublic commentcomment onon thethe indazol-3-yll(naphthalen-1-jndazol-S-ylJfjiaphthalen-l- viewview onon Regulations.gov.Regulations.gov. IfIf youyou havehave proposedproposed ConsentConsent Decree.Decree. CommentsComments yl)methanoneyljmethanone (THJ-2201)(THJ-2201) werewere receivedreceived aa CommentComment TrackingTracking Number,Number, shouldshould bebe addressedaddressed toto thethe AssistantAssistant temporarilytemporarily placedplaced inin scheduleschedule II ofof thethe youryour commentcomment hashas beenbeen successfullysuccessfully AttorneyAttorney General,General, EnvironmentEnvironment andand ControlledControlled SubstancesSubstances ActAct byby aa fifinalnal submittedsubmitted andand therethere isis nono needneed toto NaturalNatural ResourcesResources ➢ivision,Division, andand shouldshould orderorder publishedpublished byby thethe DrugDrug resubmitresubmit thethe samesame comment.comment. PaperPaper referrefer toto UnitedUnited StatesStates andand thethe StateState ofof EnforcementEnforcement AdministrationAdministration onon Januarylauuary commentscomments. ththatat duplicateduplicate anan electronicelectronic IndianaIndiana v.v. ExideExide Technologies,Technologies, O.J.D.J. Ref.Ref. 3D,30, 20152015 (80(80 FRFR 5042).5042). ThisThis meansmeans thatthat submissionsubmission areare notnot necessarynecessary andand areare . . No.No. 90-5-2-1-11003.90-5-2-3 -J 1 003. AllAll commentscomments - anyany personperson thatthat wisheswishes toto manufacturemanufacture discouraged.discouraged. ShouldShould youyou wishwish toto mailmail aa mustmust bebe submittedsubmitted nono laterlater thanthan thirtythirty AB-CHMINACA,AB-CHMINACA, AB-PINACA,AB-PINACA, oror THf-THJ- paperpaper commentcomment inin lieulieu ofof anan electronicelectronic (30)(30) daysdays afterafter thethe publicationpublication datedate ofof 22012201 afterafter JanuaryJanuary 30,30, 2015,201S, mustmust bebe comment,comment, itit shouldshould bebe sentsent viavia regularregular thisthis notice.notice. CommentsComments maymay bebe registeredregistered withwith thethe DrugDrug EnforcementEnforcement oror expressexpress mailmail to:to: DrugDrug EnforcementEnforcement submittedsubmitted eithereither byby emailemail oror byby mail:mail: AdministrationAdministration andand havehave obtainedobtained aa Administration,Administration, Attention:Attention: DEADBA FederalFederal manufacturingmanufacturing quotaquota pursuantpursuant toto 2121 RegisterRegister Representative/011%L,Representative/ODXL, 87018701 ToTo submitsubmit CFR Morrissette Drive, Springfield, Virginia SendSend Ththemem a:to: CFR partpart 1303.1303. Morrissette Drive, Springfield, Virginia comments:comments: TheThe DrugDrug EnforcementEnforcement 22152.22152. AdministrationAdministration cannotcannot issueissue individualindividual ByBy emailemail pubcomment-eelenrd@pubcomment-ees. enrd@ FORFOR FURTHERFURTHER INFORMATIONINFORMATION CONTACT:CONTACT: manufacturingmanufacturing quotasquotas forfor AB-AB- usciej.gov.usdoj.gov. ImeldaImelda L.L. Paredes,Parades. OfficeOffice ofof DiversionDiversion ByBy mailmail AssistantAssistant AttorneyAttorney GeneralGeneral CHMINACA,CHMINACA, AB-PINACA,AB-PINACA, oror TH1-2201TfIJ-2201 Control,Control, DrugDrug EnforcementEnforcement until it establishes U.S.U.S. DOJ—ENRODOJ— ENRD until it establishes aggregateaggregate productionproduction Administration;Administration; MailingMailing Address:Address: 87018701 Therefore, this notice P.O.P.O. BoxBox 16117611 quotas,quotas. Therefore, this notice, , proposesproposes, MorrissetteMorrissette Drive,Drive, Springfield,Springfield, VirginiaVirginia Washington, 20044- Washington, D.C.D.C. 20044 the 2015 aggregate production quotas for 22152; Telephone: (202) 596-6812. 7611.7611, AB-CHRENACA, AB-PINACA. and THE SUPPLEMENTARY INFORMATION: 2201.2201. DuringDuring thethe publicpublic commentcomment period,period, DATES:DATES: InterestedInterested personspersons maymay filefile PostingPosting ofof PublicPublic CommentsComments thethe ConsentConsent DecreeDecree maymay bebe examinedexamined writtenwritten commentscomments onon thisthis noticenotice inin PleasePlease notenote thatthat allall commentscomments andand downloadeddownloaded atat thisthis JusticeJustice accordanceaccordance withwith 2121 CFRCFR 1303.11(c).1303.11(c). received in response to this docket are ➢epartmentDepartment WebWeb site:site: http://http:// received in response to this docket are ElectronicElectronic commentscomments mustmust behe considered part of the public record and www.usdolgovienrd/Consent_www.usdoj.gov/enrd/Consent_ considered part of the public record and submitted,submitted, andand writtenwritten commentscomments mustmust willwill bebe mademade availableavailable forfor public Decrees.html.Decrees.html. WeWe willwill provide aa paperpaper public bebe postmarked, onon oror beforebefore April 20,20, inspectioninspection onlineonline atat http://http:// copycopy ofof thethe ConsentConsent Decree uponupon 2015.2015. CommentersCommentors shouldshould bebe awareaware thatthat www.regutvww.regulations.gov. lationsgov. SuchSuch informationinformation writtenwritten requestrequest andand paymentpayment ofof thethe electronicelectronic FederalFederal DocketDocket includesincludes personalpersonal identifyingidentifying reproductionreproduction costscosts (at(at 2525 centscents perper ManagementManagement SystemSystem willwill notnot acceptaccept informationinformation (such(such asas youryour name.name, page).page). PleasePlease mailmail youryour requestrequest andand aa commentscomments afterafter 11:5911:59 p.m.p.m. EasternEastern TimeTime . address,address, etc.) voluntarilyvoluntarily submittedsubmitted byby checkhk or mmoney y orderd pyblpayable toto thethe etc.) c onon thethe lastlast dayday ofof thethe commentcomment period.period. thethe commenter,commenter, UnitedUnited StatesStates TreasuryTreasury to:to: ConsentConsent BasedBased onon commentscomments receivedreceived inin TheThe FreedomFreedom ofof InformationInformation ActAct DecreeDecree Library.Library. U.S.U.S. DOJ—ENRD,DOJ—ENRD, P.O.P.O. responseresponse toto thisthis Notice, thethe appliesapplies toto allall commentscomments received.received. IfIf you BoxBox 7611, Washington, DC 20044-7611. 7511, Washington, DC 20044-7611. AdministratorAdministrator maymay holdhold aa publicpublic wantWant toto submitsubmit personalpersonal identifyingidentifying TheThe costcost forfor aa paperpaper copycopy ofof thethe hearinghearing onon onoone oror moremore issuesissues raised.raised. InIn informationinformation (such(such asas youryour name.name, ConsentConsent ➢ecreeDecree isis 58.25.58.25. thethe eventevent thethe AdministratorAdministrator decidesdecides inin address,address, etc.)etc.) asas partpart ofof youryour comment,comment, RandallRandall M.M- Slone,Stone, herher solesole discretiondiscretion toto holdhold suchsuch aa butbut dodo notnot wantwant itit toto bebe postedposted onlineonline ActingActingAssistant Assistant SectionSection ChiefChief, hearing,hearing, thethe AdministratorAdministrator willwill publishpublish oror mademade availableavailable inin thethe publicpublic docket,docket, EnvironmentalEnvironmental EnforcementEnforcement Section,Section, aa noticenotice ofof anyany suchsuch heatinghearing inin thethe youyou mustmust includeinclude thethe phrasephrase EnvironmentEnvironment andandNatural Natural ResourcesResources Division.Division. FederalFederal Register.Register. AfterAfter considerationconsideration ofof "PERSONAL"PERSONAL IDENTIFYINGIDENTIFYING IFRIfr Oendoc. 2015-0636920i5-t»6369 FiledFiled 3-10-1S;3-io-i5; fleiSa:4s emlam| anyany commentscomments andand afterafter aa hearing,hearing, ifif oneone INFORMATION"INFORMATION" inin thethe firstfirst paragraphparagraph BILLINGBIUING CODECODE 441044I0-1S-P-1s-e isis held,held, thethe AdministratorAdministrator willwill publish ofof youryour comment.comment. YouYou mustmust alsoalso placeplace inin thethe FederalFederal RegisterRegister aa finalfinal orderorder allall thethe personalpersonal identifyingidentifying informationinformation establishingestablishing thethe 20152015 aggregateaggregate youyou dodo notnot wantwant publicly availableavailable inin DEPARTMENTDEPARTMENT OFOF JUSTICEJUSTICE production quotasquotas forfor AB-CIIMINACA,AB-CHMINACA, thethe fifirstrst paragraph ofof youryour commentcomment andand ABRINACA,ABrFINACA, andand THJ-2201.THJ-2201. identifyidentify whatwhat informationinformation youyou wantwant DrugDrug EnforcementEnforcement AdministrationAdministration ADDRESSES:ADDRESSES: ToTo ensureensure properproper handling redacted.redacted. (Docket[Docket No.No. DEA-41D1DEA-410] ofof comments,comments, please referencereference "Docket"Docket IfIf youyou wantwant toto submitsubmit confidentialconfidential No.No. DEA-410"DEA-410" onon allall correspondence,correspondence, business informationinformation asas part ofof youryour ControlledControlled Substances:Substances: 2015201 5 ProposedProposed includingincluding anyany attachments,attachments. The LintDrug comment,comment, but dodo not want itit toto be made Aggregate for Aggregate ProductionProduction QuotasQuotas for Enforcement Administration encouragesencourages publicly available,available, you must includeinclude thethe Three Temporarily ControlledControlled thatthat allall commentscomments be submittedsubmitted , phrase "CONFIDENTIAL"CONFIDENTIAL BUSINESS SyntheticSynthetic CannabinoldsCannablnolds electronicallyeloctronically throughthrough thethe Federal INFORMATION"INFORMATION" inin thethe fifirstrst paragraphparagraph AGENCY:agency: DrugDrug EnforcementEnforcement eRulemakingcRulemaking Portal whichwhich provides thethe ofof your comment.comment. YouYon must alsoalso identify confidential Administration, Department of lusting.Justice. abilityability toto typetype shortshort commentscomments directly prominently identify confidential intointo thethe commentcomment fieldfield onon thethe Web page business informationinformation toto be redactedredacted ACnON:action: NoticeNotice with requestrequest forfor or attachattach aa filefile forfor lengthierlengthier comments.comments. within thethe comment.comment. IfIf aa commentcomment has comments. Please go toto http://www.regulotions.govhttp://www.regulations.gov soso much confidential business SUMMARY: Three syntheticsynthetic cannabinoids: andand followfollow thethe online instructionsinstructions atat informationinformation thatthat itit cannot be effectively N-(1-amino-3-methyl-t-oxobutan-2-y1)-N-(l-amino-3-ineuiyl-i-oxobutan-2-yl)- thatthat sitesite forfor submittingsubmitting comments.comments. UponUpon redacted,redacted, allall oror partport ofof thatthat commentcomment 1-(cyclohexylmethyl)-1H-indazole-3-l-fcyclohexylmethyl)-lH-inda2o)e-3- completion of your submissionsubmission you willwill may not bebe posted onlineonline oror mademade carboxamide (AB-CHMINACA).(AB-CHMINACA). NN-(l--(1- receive aa Comment Tracking Number forfor available inin thethe public docket.docket, c amino-3-methyl-l-oxobutan-2-yl)-l-n1 -3-rn thy1-1-oxobutan-2-y1)-1- your comment:comment. Please be aware thatthat Comments containing personal pentyla.H-indazole-3-carboxamidepentyl-lH-indazole-3-carboxamide (AB-(AB- submittedsubmitted comments are not identifyingidentifying informationinformation or confidential Vol. I Page 881881 t. FederalFederal Register/Vol.Register/ Vol. 80,80, No.No. 54/Friday,54/Friday, MarchMarch 20,20, 20152015/Notices /Notices 1503515035 businessbusiness informationinformation identifiedidentified asas syntheticsynthetic cannabinoids:cannabinoids: N-(1-amino.3-N-(l-amino-3- InIn determiningdetermining thethe 20152015 aggregateagg regate L directeddirected aboveabove willwill bebe mademade publiclypublicly methyl.1.oxobutan-2-y1)-1-methyM-oxobutan-2-yl)-l- productionproduction quotasquotas ofof thesethese threethree availableavailable inin redactedredacted form.form. (cyclone{cyclohexylraethylJ-JH-indazole-H- xylmethyl)-1H-indazol syntheticsynthetic cannabinolds,cannabinoids, thethe AnAn electronicelectronic copycopy ofof thisthis documentdocument carboxamidecarboxamide (A13.CHMINACA),(AB-CHMINACA), N-(1-N-(l- AdministratorAdministrator consideredconsidered thethe followingfollowing isis availableavailable atat Mind/htlp:// amino-3-methyl-1-oxobutan-2-y1)-1-amino-3-methyl-l-oxobutan-2-yl)-l- factorsfactors inin accordanceaccordance withwith 2121 U.S.C.U.S.C. www.regularianagovwww.regulatians.gov forfor easyeasy reference.reference. pentyl-thdndazole-3-carboxamidepentyl-lH-indazole-3-carboxamide (AB-(AB- 826(a)826(a) andand 2121 CFRCFR 1303.11(h):1303.11(b): (1)(1) TotalTotal IfIf youyou wishwish toto personallypersonally inspectinspect thethe PINACA),PINACA), andand I1-(5-fluoropentyl)-1H-|l-(5-fluoropnntyl)-lH- netnet disposaldisposal ofof thethe classclass byby allall commentscomments andand materialsmaterials received,received, thesethese indazol-3-yl)fnaphtha1en-1-,indazol-3-yl](naphthalen-l- manufacturersmanufacturers duringduring thethe currentcurrent andand 22 preceding materialsmaterials willwill bebe availableavailable forfor publicpublic yihnethanoneyl)methanone (THJ-2201)(THI-2201) intointo scheduleschedule precedingyears;years; (2)(2) trendstrends inin thethe national rate of net disposal of the class; inspectioninspection bybv appointment.appointment. ToTo arrangearrange I Iofof thethe GSACSA (79(79 FRFR 75767).75767). OnOn JanuaryJanuary national rate of net disposal of the class; aa viewing,viewing, pleaseplease see the FOR FURTHER (3) total estimated inventories of the see the FOR further 30,30, 2015,2015, thethe DEADEA publishedpublished inin thethe , . (3) total estimated inventories of the INFORMATIONINFORMATION CONTACTCONTACT basic class and of all substances paragraphparagraph above.above. FederalFederal RegisterRegister aa finalfinal orderorder toto basic class and of all substances manufacturedmanufactured fromfrom thethe class,class, andand trendstrends LegalLegal AuthorityAuthority andand BackgroundBackground temporarilytemporarily placeplace thesethese threethree syntheticsynthetic inin inventoryinventory accumulation;accumulation; (4)(4) projectedprojected cannabinoidscannabinoids inin scheduleschedule [ofI of thethe CSACSA SectionSection 306306 ofof thethe ControlledControlled demanddemand forfor eacheach classclass asas indicatedindicated byby (80(80 FRFR 5042),5042). makingmaking allall regulatoryregulatory • SubstancesSubstances ActAct (CSA),(CSA), 2121 U.S.C.U.S.C. 826,826, procurementprocurement quotasquotas requestedrequested pursuantpursuant controlscontrols pertainingpertaining toto scheduleschedule II requiresrequires thatthat thethe AttorneyAttorney GeneralGeneral toto 2121 CFRCFR 1303.12;1303.12; andand (5)(5) otherother factorsfactors controlledcontrolled substancessubstances applicableapplicable toto thethe establishestablish aggregateaggregate productionproduction quotasquotas affectingaffecting medical,medical, scientific,scientific, research,research, manufacturemanufacture ofof thesethese threethree syntheticsynthetic forfor eacheach basicbasic classclass ofof controlledcontrolled andand indifstrialindustrial needs of the United cannabinoids,cannabinoids, includingincluding thethe needs of the United substancesubstance listedlisted inin schedulesschedules I 1andand IIII StatesStates andand lawfullawful exportexport requirements,requirements, requirementrequirement toto establishestablish anan aggregateaggregate eacheach year.year. ThisThis responsibilityresponsibility hashas beenbeen asas thethe AdministratorAdministrator fifindsnds relevant.relevant. productionproduction quotaquota pursuantpursuant toto 2121 U.S.C.U.S.C. delegateddelegated toto thethe AdministratorAdministrator ofof thethe TheseThese quotasquotas dodo notnot includeinclude importsimports ofof 826826 andand 2121 CFRCFR partpart 1303.1303. DrugDrug EnforcementEnforcement AdministrationAdministration controlledcontrolled substancessubstances forfor useuse inin IDEAL(DEA). 2828 CFRCFR 0.100.0.100. AB-CHMINACA,AB-CHMINACA, AB.PINACA.AB-PINACA, andand industrialindustrial processes.processes. TheThe DEADEA establishedestablished thethe 20152015 THJ-2201THJ-2201 werewere nonnon-controlled-controlled TheThe Administrator,Administrator, therefore,therefore, aggregateaggregate productionproduction quotasquotas forfor substancessubstances whenwhen thethe aggregateaggregate proposesproposes thatthat thethe annualannual 20152015 aggregateaggregate substancessubstances inin schedulesschedules II andand IIII onon productionproduction quotasquotas forfor scheduleschedule I 1andand IIII productionproduction quotasquotas farfor thethe followingfollowing SeptemberSeptember 8.8, 20142014 (79(79 FRFR 53216).53216). substancessubstances werewere established.established. ThereforeTherefore temporarilytemporarily controlledcontrolled scheduleschedule II Subsequently,Subsequently, onon DecemberDecember 19,19, 2014,2014, nono aggregateaggregate productionproduction quotasquotas forfor AB.AB- controlledcontrolled substances,substances, expressedexpressed inin DEADEA publishedpublished inin thethe FederalFederal RegisterRegister 1 CIIMINACA,CHMINACA, AB-PINACA,AB-PINACA, andand THETHJ- gramsgrams ofof anhydrousanhydrous acidacid oror base,base, bebo aa noticenotice ofof intentintent toto temporarilytemporarily placeplace 33 22012201 werewere establishedestablished atat thatthat time.time. establishedestablished asas follows:follows: ProposedProposed class—schedule I 2015 quota L BasicBasic class—schedule I 2015(9)(juota N-(1-errino-3-methyl-1-oxobulao-2.y1).1.(cyclohexylmolhell-1H-IndazoieN-(1-amlno-3-rtiethyM-oxobutan-2-yl)-1-(cyclotiexylmclhyl)-1H-lndazoie-3-carboxamide-3-carooxamide (AB-CHMINACA)(AB-CHMINACA) 1515 NN-(1-aitiino-3-meihyM-oxobutan-2-yl)-1-pentyMH-ln(la20le-3-carboxamlde-(1-are ino-3-methyl-l-oxebulan-211)-1-pentyl-1H-Indazole-3-earboxamIde (AB-PINAGA)(AB-PINACA) 1515 (14S4uoropenty1)-1H-Indazol-3-ylgnaptilhaten-1-ylimethanone(1-(5-fluoropentyl)-1H-lndazol-3-yiKnaphlbaleri-i-yl)methanonB (TH..1-22011(THJ-2201) 1515 Bated.Dated; MarchMarch 12,12, 2015.2015. InstituteInstitute forfor EnvironmentalEnvironmental ConflictConflict NUCLEARNUCLEAR REGULATORYREGULATORY MicheleMichete M.M. Lennhart,Lennhart, Resolution,Resolution, andand UdallUdall CenterCenter forfor StudiesStudies COMMISSIONCOMMISSION SidiruniseaAdministrator. tor. inin PublicPublic Policy/NativePolicy/Native NationsNations InstituteInstitute 1111[FR DecDoc. 2015-0945n2015-00456 FiledFiled 3-19-15:3-19-15; 5:458:40 amtami forfor Leadership,Leadership, Management,Management, andand (NRC-2015-0001)IN RC-201 5-0001] BILLINGBIILINO CODECODE 4410-09.4410-08-P Policy/UdallPolicy/Uriah Archives,Archives, andand resolutionsresolutions relatedrelated toto thethe OperatingOperating ProceduresProcedures ofof SunshineSunshine ActAct MeetingsMeetings thethe BoardBoard ofof TrusteesTrustees andand thethe ParksParks inin FocusFocus Fund,Fund. Inc.Inc. (6) Financial end 0 March 23, 30, April 6, 13. 20. 27, MORRISMORRIS K.K. UDALLUDALL AND STEWART L. (6) Financial and DATES: March 23, 30, April 6, 13. 20. 27, AND STEWART L. Internal Controls Update; (7) Ethics 2015. UDALLUDALL FOUNDATIONFOUNDATION Internal Controls Update; (7) Ethics 2015. Briefing:Briefing; (8)(8) ProgramProgram PanelPanel && PLACE:place: CommissionersCommissioners' ConferenceConference SunshineSunshine ActAct MeetingsMeetings Discussion:Discussion; andand (9)(9) AppropriationsAppropriations Room,Room, 1155511555 RockvilleRockville Pike,Pike, Rockville,Rockville, • Update.Update. .. Maryland.Maryland. TIMETIME ANDAND DATE:DATE: 0:000:00 a.m.a.m. toto 9:004 :00 p.m.,p.m., CONTACTCONTACT PERSONPERSON FORFOR MOREMORE INFORMATION: Thursday, April 1616, 2015.2015. INFORMATION: STATUS:STATUS: Public andand Closed.Closed. Philip J.J. Lemanski, Executive Director, PLACE:place: The officesoffices of thethe MorrisMoiris K. 130130 SmithSouth ScottScott Avenue,Avenue, Tucson, AZ WeekWeek ofof MarchMarch 23,23, 20152015—Tentative—Tentative UdellUdall andand StewartStewart L.L. UdallUdall Foundation,Foundation, Tucson, AZ 85701,85701, (520)(520) 901-8500.901-8500. 130130 SouthSouth ScottScott Avenue,Avenue, Tucson.Tucson, AZAZ Thursday,Thursday, MarchMarch 26,26, 20152015 85701.85701. Dated:Daied: MarchMarch 16.16, 2015.2015. 9:309:30 a.m.a.m. BriefingBriefing on Security Issues STATUS:STATUS: ThisThis meetingmeeting ofof thethe BoardBoard ofof PhilipPhilip J.J. Lemanski,Lemanski, on Security Issues (ClosecD-Ex.(Closed—Ex. 1)1) TrusteesTrustees willwill bebe openopen toto thethe public.public. ExecutiveExecutive Thirster, Mons K. Udall and Director, Morris K. Udall and 1:30 p.m. Briefing on Security Issues MATTERSMATTERS TOTO BEBE CONSIDERED:CONSIDERED: (I)(l) Chair'sChair's StewartStewart L.L. UdallUdall Foundation,Foundation, andand &demiFederal 1:30 p.m. Briefing on Security Issues (Closed(Closed——Ex.Ex. 1) Remarks; (2)(2) Executive Director'sDirector's RegisterRegister LiaisonLiaison Officer.Officer. 1) Overview IFR[FR Nac.Doc. 2015-095562015-06556 Filed 3-18-15:4:15 pin] Remarks; (3)(3) Overview ofof TrusteeTrustee Filed 3-18-18; 4:15 ]Jrn| Friday.Friday, MarchMarch 27.27, 20152015 Responsibilities; (4)(4) Board OfficersOfficers && BILLING9ILLINO CODECODE an20-ni-BM2D-FW-# CommitteeCommittee Elections; (5)(5) ConsentConsent 9:309:30 a.m.a.m. Briefing anon Threat c Agenda Approval, includingincluding program Environment Assessment (Closed(Closed-— reportsreports of thethe Education Programs, U.S. Ex.Ex.!) 1) Vol. I Page 882882 J J J 2015 Riwt.d; APO Basic Claes:t 905043 Workah..am 2 If 8 FDA s it Est S C5 PO Totd(C12.F13), 27,210,759.001is 12 151-9 IF Est: 21% ki £ 3 5 o 3 5 X s Dm, 00149 3 I $ 3 I 5 1 £ f CFR 20% Um ot I 3 B I 2014 Protected CMc ire a § c 8 e12014 Ed 2015 toted PO 11100010n4 2315 Exports nq CFA§ B 5 5 f i % Sala • Stun 97%Iner.1 Ruel 1 2015 MO 100 s Compsny DEA Nun Rsq.4.1! 2015 MC 2314 Sae. 2014 Tote! %Ode 1.50) 0.000 •1800 • K S 5.000 5000 0,000 25,005,542.315 0.003 0.030 .1.60, 0.000= m K (b)(4) (b)(7)(E)§ 0.000 coo, i 35,665 42.664 4.063 10.742 100.000 25,005,501.310B 0.000 100.000 33.826 I 0.000 0000 § 0.000 OM 0.000 S 628,000.000 020.000030 0000 2500$.542.3198 0000 0.000 2 K 247,150.000N 0.000 00,2724 t 1 130.700.741 0.000 1 zw000.ox 241,202.000 2 S 0009 266,483.393 298,003.000 5,005,5? 42219 8 £ 3* 5 U M?6; = § §§§?§* : N 10,4115,214225 12/32.454226 3,913,229.003'S 2,086849.000 0.000 pp. S 5 .5 10,400,000.000 1 1.8co.00 000 5,779,025003 25,605„.42.319 0,343 9222,125,230I -425774 § 505.534 0.000 -494.924 0.000 S 1,000.000 1,000.000 1.108 25605,542,319§ 0.000 4.431 S a £ O 20,690021.52)3 0000 8 8 s 0.000 17,575,913.381 K 16,928,427.216 . 1,200,520.000 5 0.620 I 25,501000000 18 ,714000.000 15.885.650.000 25,705,542719g . £ - 3lfM8klS al§§§I§«.g 1,095,014.095 oppooo«o~ £ §§§§§§§§ llllllii liiiiiiioOpOOCOo §§-§«§ 0003 § i§si§§§§ llllllii" 31 iigiiisi1 S IlisipS; - ?is3?5 SSSS5SSS 0.000 950,158.382 2338SIS3 IS»SSo8p| Ikklklll3 1,0113,1£01.003 009,547.030SKP!fi#pf 0027 Z43,620218' 7,546.003 3 2,070000030 25,805,542 319ISHSHif : " 5 § 04200 3 £ I 21,02.2.1es.Is7 I IO a £ £ a 2,696,844.000 8 i a -3 i I ,411,291.033 8 6,449,008.750 MO Totals: 40496,205.000 'I 25,056.541.5% Float /nine APO-. 33,600000000 > g * O 3 3 Proposed Revised: 51,(n2,320 020 (1MS cc( c5g 000102U> cOtreol AP() than rounded up)1 s ! I J & r- III ! I? ?s 5 ?! (0[6125% burfer); I Pro po see tieedred 3.815.400,003 (64,0617,1500 rounded up) 2. Ftnal Payload APO: 0.000 5 I n S S MO Noocl.P0. 1.6 - Rented MO • Inventory: 5 1757.777.233 cP1 03%:. W.473.202 2014 toPial APO: 39,900000E0 FDA Est . 2014 APO '41 • FDA Er* 25020,540.030 ilium M fHiilli sisMin Ills s» IMS Est. 2016 APO • (1 • IMS ** 47,571,480 OW I I 1 "Q Penerin2 requests:1 2015100„ ? Is 8 * 5 I I Cone214er DEANA.. cu ern MO qpuist possible you.| di/t..,00, - s 3 | 'I 11,070.0000m 13,003,000.000 2,000003003e m 16,400,000.000 — g 3 - g (b)(4) (b)(7)(E)3 B § s '§ 16,170.000030 25,250,000000 24,531,000.000 7,701,000.000-i u M III III Ills III III C "I 3 1,910.186.000 3,070.000.000mis 3,070.000400 1 ;753,014.1111 000 i ! 11,614,814.0005 rfi s - § « CODEINEg (FOR SALE) § «r "0 Q) CO CD CO Page w Vol. I May 14,14, 2015 Dr. Christine SSaanerud amend Drug Enforcement Administration Office of Diversion Control 8701 MorrisetteMomsette Drive Springfield, VA 22152 Dear Dr. Saruaerud:Sannerud: (b)(4)(b)(4);(b)(7)(E) (b)(7)(E) lisis requestingrequesting an increase inin 2015 CPS morphine (9670)(9670) and CPS codeine (9670) procurement quota. |(b)(4);b)(4) |alsoalso requests additional 2015 morphine for sale (9300), morphine forfor conversion (9300),(9300), and codeine for salesale (9050)(9050) manufacturing quota. 2015 Granted Requested IncreaseIncrease Quota Category Material Name Quota (kg)(kg) Quota(kg) M(kg) CPSCPS-Morphine-Morphine -— 9670 NET 38,99938,999 80,00080,000 41,001 Procurement CPSCPS-Morphine--Morphine — 9670 asas kgBKgB 31,199 64,000 32,80132,801 CPSCPS-Codeine-Codeine —-9670 9670 NET 6,3666,366 9,988 3,6223.622 LL Procurement CPSCPS-Codeine-d ine —- 9670 as kgB j 5,417 8,500 3,083 Total Morphine300 for Conversion Manufacturing 13,46313,463 24,60024300 11,03711,037 --9300 9 Morphine for Conversion forfor 24,097 10,63410,634 24,097 Codeine Morphine for Conversion forfor 403 403 403 oxyrnorphoneoxymorphone Manufacturing Morphine forforSale-9300 Sale — 9300 19.54619.546 26,000 6,454 Manufacturing CodeineCodeine For Sale -- 9050 16,76916,769 28,250 (f\ - 11,48111,481 >1 •• . Current Situation 1))(4) •• CPS Morphine isis thethe startingstarting material forfor twotwo ;|'b"'Jl [hug• g products: Morphine Sulfate and Codeine Phosphate (via(via morphine for conversionconversion category). ' •• Morphine salessales have increased over 2014. 1(b)(4)(b)(4) [holdsbolds a contract withwithKb)(4);(b)(7)(E) 'W(4) (b)(7)(E) landand . |(b)(4)-(b)(7)(E)~frequiringb)(4)(b)(7)(E) -equiririg supply of 80% of theirtheir requirements. As a result of exhausting inventory fromfrom another supplierj(b)(4)supplierjfb)(4) [willwill reqrequireuire [b)(4)b)(4) |toto begin supplyingsupplying in 2015.'_b)(4)2015. 1(b)(4) |hasbas already suppliedsnpplied initial,initial, uti-forecastedun-forecasted quantities.quantities, [(b)(4)b)(4) |expectsxpects demand toto be approximately 4,000 toto 6, 000 kg saltsalt due inin part to base business not previously suppliedsupplied by |(b)(4)(b)(4) |but also driven by substitutionsubstitution forfor hydrcoodone.hydrocodone. •• |(b)(4)(b)(4) Codeine|Codeine sales have increased significantly compared toto recent years. This may potentially be attributed toto the reschedulinrescheduling of hydrocodocehydrocodone and the movement of physicians to other scheduleschedule ila-Vffl-V pain medication.nadication.[ ;b1(4)bK4) keyey codeinecodeine customer,customerJW(4) (b)(4) |hashas requested supplysupply increase for I 2015 of 18.00018,000 kg saltsalt and isis predicting 22,000 kg salt requirement forfor. 2016. L Page 11 of 20 CONFIDENTIAL BUSINESS INFORMATION Vol. I Page 884884 L Procurement and Manufacturing Quota Increase Request -(b)(4)(b)(4);(b)(7)(E) (b)(7)(E) CPS Morphine (9670) , CPS Codeine (9670), Morphine for Conversion (9300), Morphine for Sale (9300)<9300) and Codeine for Sale (9050) May 14,14,2015 2015 • Tasman codeine sales slowly increase as suUSppcucustomersliedstomeo rs on board andandp)W " 4) 'international{international sites consume thetbe Tasman API.API.|(b)(4) (b)(4) |has supplied )'b)(4) Ihistorically since the Tasman introduction. In 20I4Kb)(4)2014 ;b)(4) ' (received'received qualification samples with bulk API delivered in 2015. (b)(4)WW {will will be requiring qualification material in 2015 with commercial volume in 2016. • The requested quota increases will provide adequate morphine and codeine inventory to support our fifirstrst quarter 2015 sales and will be under the 5(1%50% year-end level requirementrequirement. • With the recent change to reporting CPS as net and with the increase API demand, the initial CPS MorphineMo .hine and CPS Codeine procurement quota grant does not provide enough material to support the[[b)(4)the ;b)(4) [201515 production plan for both morphine for sale and codeine for sale while allowing for adequate year-end inventory to support IQ2016. TheHie CPS needed to produce the planned "volumes'volumes of morphine and codeine can be found in Appendix A. Timing • The current CPS Morphine and CPS Codeine procurement quota grant will impactimpact the supply chain in November. . • The additional morphine for sale quota is required in the fall to support the remaining 2015 production and provide adequate year-end inventory. • The additional codeine is required by June to support the remaining 2015 production and provide adequate year-end inventory. Quota JustificationjustiB cation -— Process Losses,Losses. Morphine Sales « |(b)(4) b)(4) s notifying DEA in this letter of the actual processing losses for the purified morphine sulfate stepssteps (PMS)(FMS) and codeine phosphate stepssteps (CPI(CPH).-1). The quota requested includes replacement quota for the material lost inin the waste water streams.streams. The process losses for both products can be found in Appendix A. • 2015 Morphine sales are shown in Table I and the 2015201 5 Codeine sales are shown in Table ILIL Supporting POs available can be found in Appendix B. L Page 2 of 20 CONFIDENTIAL BUSINESS INFORMATION Vol. I Page 885885 L Procurement and Manufacturing Quota Increase Request --|(b)(4)i(b)(7)(E)|(b)(4):(b)(7)(E) CPS Morphine (9670) , CPS Codeine (9670), Morphine for Conversion (9300), Morphine for Sale (9300) and Codeine for Sale (9050) May 14, 2015 Table 1:I: 2015 Codeine for Sale YTD SaksSales and Forecast 2015 Codeine from Mor7hlneMorphine Sales, kg Base JanJan- - May • Joly-In1y- Oct-- 2815MIS Customer RegReg# 4 April June • Sept Dec Total (b)(4)(b)(7)(E)(b)(4);(b)(7)(E) 0.1 -, - - 0.1 - 44.4 88.8 - 1332133^ 0.1 - - - 0.1 50.1 166.5 111.0111.0 134.7 46X3462-3 - . coSta 372.2 370.0 1,462.21.462.21 1,446.7✓1 ,446.7, ' 3,651.23fiS12 Oft 0 42.3 421.8421. B 252.3 716.57163 1.0 0.7 - 1.7 101.9I01.9 11.8 44.4 96.2 254.32543 0.2 - 0.2 858.2 606.1 966.4 - 2,430.12^30.7 L 75_5755 18.518.5 44.094.0 2.2 - - - 2.2.23 . . _ . 1 . _ - - • 111.0lli.O 111,0. 481.0 1,342.41,342,4 t 2,045.43,045,4 692.6692,6 865.8 w 1,858.91,858,9 2,516.02316.0 5955,933.333 (c,87%35 3{6,A:ire4), . _ . . Total 1307.42307.4 2,597.42397-4 5,224.3S 084.3 V 5,535.95335.9 15,725.115,725,1 Intercompany Movement for |;b)(4):(b)(7)(E)b)(4):(b)(7)(E) 0.80.B - testing 2015 Codeine from Tasman Sales, kg Base (b)(4).(b)(7)(E)(b)(4);(b)(7)(E) 1,110.01,110.0 1,184.01,184.0 740.0 1,480.01,480.0 4,514.0 37.7 - - _ 37.7 107,3107.3 - - - 107.3107.3 0.0 - - - 0.0 - 296.0 - ,_ 370.0 666.0 Total 1,255.1 1,480.0 5,325.1 Total 1,255.1 1,480.0i 740.0 1,850.01,850.0 5,325.1 Intercompany Movement forfor (b)(4):(b)(7)(E);b)(4);(b)(7)(E) 0.5 - - testing LL Page 33 of 20 CONFIDENTIAL BUSINESS INFORMATION Vol. I PageRage 886886 ProcurementProcurement andand ManufacturingManufacturing QuotaQuota IncreaseIncrease RequestRequest -|(b)(4);(b)(7)(E)- b)(4)(b)(7)(E) '• . CPSCPS MorphineMorphine (9670),(9670), CPSCPS CodeineCodeine (9670),(9670), MorphineMorphine forfor ConversionConversion (9300),(9300), MorphineMorphine forfor SaleSale (9300)(9300) andand Codeine forfor SaleSale (9030)(9050) MayMay 14, 2015. TableTable II:II: 20152015 MorphineMorphine forfor SaleSale YTDYTD SalesSales andanti ForecastForecast Jan-.Ru2- May - InlyJuly Oct- 2015 CustomerCustornzr Rcg#Reg # 1 AprilApril JtlneJune StptSept DecDec TotalTotal (b)(4);(b)(7)(E)(b)(4)(b)(7)(E) 0.50.5 - - OS0.5 0.20.2 - - .. 030.2 657.3657.3 1,630.5 1,687.5 3,975.33,9783 7.5 - 14.3143 - 21.821.8 233.3 36.8 - 29B.5298.5 S6SS568.5 - - 600.0 - 600.0600.0 0.7 - - - 0.70.7 86.4 95,395.3 150.0 - 3M.6331.6 1.51,5 - 0.8 0.8 3.0 - - - •' 159.0 159.0 - 198.8 - 198.8 150.0 - 150.0 225.0 525.0 - 18.8 - 37.5 56356.3 73.0 - 60.0 133.0 . _ . . - 300.0 300.0 300.0 900.0 - 9.0 - 9.0 3,369.43369.4 - 4,500.0 750.0 8,6I9A8,619.4 51,051.0 - 51.0 22.1 - - 22.1 - 257.3 198.0 - 4553 83Xi 83.0 - - 83.0 481.9 360.3 543.8 915.0 2,301.02301.0 1 3.8 - - 3.8 I16.6116.6 749.7 - - 866.38663 Total 5,287.15387.1 3,457.53,4573 6,766.56,766-S 4,373343733 19,884.3193843 Intercompany Movement for \b)(4)(b)(7)(E)(b)(4);(b)(7)(E) 1.01.0 - - - • testing Page 4 of 20 . CONFIDENTIAL BUSINESS INFORMATION Vol. I Page 887887 Procurement and Manufacturing Quota increaseIncrease Request - ,ib)(4);(b)(7)(E)b)(4) (b)(7)(E) CPS Morphine (9670), CPS Codeine (9670), Morphine for Conversion (9300), Morphine for Sale (9300) and Codeine for Sale (9050) May 14,14. 2015 Inventory . . As noted in the tables below, the current quota grants do not provide (b(b><4))(4) [sufficientsufficient quota to meet our projected 2015 dispositions nor to end 2015 with sufficient inventory to meet firstfirst quarter 2016 projected dispositions.dispositions, The quantities requested take into account processing losses. Table HI:DM CPS-MorphineCPS-Morphine Procurement Quota Request kg Base kg NET With Additional With Additional 2015 CPS-MorphineCPS-Morphine Inventory Current 2015 Current 2015 Calculations Quota Grant Quota Grant 2014 Ending Inventory 8,101 8,101 10,107'10,107 10,107ID, 107 Non saleable material ... 2 2 2 2 2014 Available End. Inv. 8,099 8,099 10,105 10,10510,105 2015 CPS Quota kgB 31,199 64,000 38,999 80,000 20132015 Dispositions: Converted to AMA for SaleSalt 30,110 30,110 37,638 37,638 Converted to AMA for ConvCony 28,02426,024 28,024 35,030 35,030 2015 Ending Inventory -18,836 13,96513,965 -23,564 17,437 Converted to % YeaYearendrend -41.1% 30.5% kgs,kgq, base 2014 Dispositions 33,516 201520 1 5 Estimated Dispositions 58.134 Average . 45,825 30% Inventory Allowance 13,74813,748 Page 5 of 20 CONFIDENTIAL BUSINESS INFORMATION Vol. I Page 888 ProcurementProcurement andand ManufacturingManufacturing QuotaQuota IncreaseIncrease RequestRequest —~|tbK4) ;b)(4) | CPSCPS MorphineMorphine (9670),(9670), CPSCPS CodeineCodeine (9670),(9670), MorphineMoiphine forfor ConversionConversion (9300),(9300), MorphineMorphine forfor SaleSale (9300)(9300) andand CodeineCodeine forfor SaleSale (9050)(9050) MayMay 14,14, 20152015 TableTable IV:IV: MorphineMorphine forfor ConversionConversion ManufacturingManufacturing QuotaQuota RequestRequest InitialInitial AdditionalAdditional 20152015 20152015 GrantGrant GrantGrant 20142014 EndingEnding InventoryInventory 1,9991,999 1,9991,999 NonNon saleablesaleable materialmaterial 33 33 20I42014 AvailableAvailable End.End. Inv.Inv. 1,9961,996 1,9961,996 20152015 APIAPI QuotaQuota 13,46313,463 24,50024,300 20152015 Dispositions:Dispositions: ConvertedConvened toto CodeineCodeine 23,05923,059 23,05923,059 ConvertedConverted toto I414-HM-HM 00 403403 ProcessingProcessing LossesLosses 4 9 V01 aLitiNIF.4. 20152015 EndingEnding InventoryInventory -7,600-7,600 3,0353,035 ConvertedConverted toto %% YearendYearend -42.2%.42.2% 16.8%16.8% kgs,kgs, basebase 20142014 DispositionsDispositions 12,57212,572 20152015 Est.Est. DispositionsDispositions 23,05923,059 AverageAverage 17,81517,815 50%50% InventoryInventory AllowanceAllowance 8,9088,908 Page 6 of 20 CONFIDENTIAL BUSINESS INFORMATION Vol. I Page 889889 ProcurementProcurement andand ManufacturingManufacturing QuotaQuota IncreaseIncrease RequestRequest —-(b)(4)(b)(4);(b)(7)(E) (b)(7)(E) CPSCPS MorphineMorphine (9670),(9670), CPSCPS CodeineCodeine (9670),(9670), MorphineMorphine forfor ConversionConversion (9300),(9300), MorphineMorphine forfor SaleSale (9300)(9300) andand CodeineCodeine forfor SaleSale (9050)(9050) MayMay 14,14. 2.0152015 TableTable V:V: MorphineMorphine forfor SaleSale ManufacturingManufacturing QuotaQuota RequestRequest InitialIn! tied 20152015 AddltionsdAdditional GrantGrant 201S2015 GrantGrant 20142014 EndingEnding InventoryInventory 6,9516,951 6,9516,951 NonNoil saleablesaleable materialmaterial 5656 5656 20142014 AvailableAvailable End.End Thlav.y. 6,8956,895 6,8956.895 20152015 APIAPI QuotaQuota 19,54619,546 26,03026,000 20152015 Dispositions;Dispositions; SalesSales 19,88419,884 19,88419,884 OfitIl . (•f93T, , Ji®i ProcessingProcessing LossesLosses mm,'`., , ,,:„Y)wsmms 4-?2(5;4r 8) 20152015 EndingEnding InventoryInventory 2,6262.626 7,5437,543 ConvertedConverted toto %% YearendYearend 14.6%14.6% 41.9%41.9% - kgs,kgs.bra bass 20142014 DispositionsDispositions 16,11316,113 20152015 EstimatedEstimated DispositionsDispositions 19,88419,884 l AverageAverage 17,99917,999 SO%50% InventoryInventory AllowanceAllowance 8,9998,999 Page 7 of 2A20 CONFIDENTIAL BUSINESS INFORMATIONINFORMATION Vol. I Page 890 ProcurementProcurement andand ManufacturingManufacturing QuotaQuota IncreaseIncrease RequestRequest -|(b)(4);(b)(7)(E)(b)(4) (b)(7)(E) CPSCPS MorphineMotphine (9670),(9670), CPSCPS CodeineCodeine (9670),(9670), MorphineMorphine forfor Conversiononversion (9300),300), MorphineMorphine forfor SaleSale (9300)(9300) andand CodeineCodeine forfor SateSate (9050)(9050) ' MayMay 14,t4,2015 2015 TableTable VItVI; CPSCPS-Codelne-Codeine ProcurementProcurement QuotaQuota RequestRequest kgkg BaseBase kgkg NETNET WithWith AdditionalAdditional WithWith AdditionalAdditional 20152015 CPSCPS-Codeine-Codeine InventoryInventory CurrentCurrent 2015 Current 2415 CalculationsCalculations 2015 Current 2015 QuotaQuota GrantGrant QuotaQuota GrantGrant 20142014 EndingEnding InventoryInventory I,7871,787 1,7871,787 2,1002,100 2,1002,100 NonNon saleablesaleable materialmaterial 00 00 00 00 20142014 AvailableAvailable End.End, biv.Inv. 1,7871,787 1,7871,787 2,1002,100 2,1002,100 2015201S CPSCPS QuotaQuota (kgB)(ItgB) 5,4175,417 8,5008,500 6,3666,366 9,9889,983 20152015 Dispositions:Dispositions: ConvertedConverted toto ACAACA forfor SaleSale 8,0366,036 8,0368,036 9,4439.443 9,4439,443 20152015 EndingEnding InventoryInventory _ -832•832 L2512,251 -977-977 2,6462,646 ConvertedConverted toto %% YearendYearend -11,8%-11,8% 32.1%32,1% kgs,kgs, basebase 20142014 DispositionsDispositions 6,0076,007 20152015 Est.Est. DispositionsDispositions 8,0368,036 • AverageAverage 7,0217,021 30%30% InventoryInventory AllowanceAllowance , 2,1062,106 TableTable VII:VII: CodeineCodeine fromfrom MorphineMorphine forfor SaleSale ManufacturingManufacturing QuotaQuota RequestRequest WithWith AdditionalAdditional CurrentCurrent 20152015 QuotaQuota GrantGrant 20142014 EndingEnding InventoryInventory 2,3722,372 2,3722,372 NonNon saleablesaleable materialmaterial 2828 2826 20142014 AvailableAvailable End. Inv.Inv. 2,3442344 2,3442344 20152015 APIAPI QuotaQuota 12,58112,581 21,50021,500 20152015 Dispositions:Dispositions: SalesSales 15,72515,725 15,72515,725 Processing Losses ielt(9.S0)mmmmi, VaktiOYA4. 20152015 Ending InventoryInventory .1,7381,738 6,5506350 ConvertedConverted toto %% Yearend -13.0%•13.0% .49.0%49.0% kgs, base 20142014 DispositionsDispositions 11,00111,001 2015 Est. Dispositions 15,72515,725 Average 13,36313,363 50% Inventory Allowance 6,681 Page 8 of 2020 CONFIDENTIALCONFIDENTIAL BUSINESS INFORMATION Vol. I Page 891891 ProcurementProcurement andand ManufacturingManufacturing QuotaQuota IncreaseIncrease RequestRequest -X4b>(4);(b>(7>(E)b)(4) (b)(7)(E) | CPSCPS MorphineMorphine (9670),(9670), CPSCPS CodeineCodeine (9670),(9670), MorphineMorphine forfor ConversionConversion (9300),(9300), MorphineMorphine forfor SaleSale (9300)(9300) andand CodeineCodeine forfor SaleSale (9050)(9050) MayMay 14,14, 20152015 TableTable VIII:VIII: CodeineCodeine fromfrom TasmanTasman forfor SaleSale ManufacturingManufacturing QuotaQuota RequestRequest WithWith CurrentCurrent AdditionalAdditional QuoteQuota 20152015 GrantGrant 20142014 EndingEnding InventoryInventory 2,0452,045 U452,043 NonNon saleablesaleable materialmaterial 99 99 20142014 Available Rad.End. Inv.Inv. 2,0362,036 2,0362,036 20152015 APIAPI QuotaQuota 4,1884,188 6,7506,750 20152015 Dispositions:Dispositions: SalesSales 5,3255,325 5,3255,325 3-7..,.. 4i,,4, - 4 ,;.., .1, ,_,..,:• n ry Processing Losses ;0;,CW(083)*..Zsin Iif tlitMill (88 ) i(A 20152015 Ending InventoryInventory 1616 2,5782378 ConvertedConverted toto %% YearendYearend 0.3%0.3% 50.2%50.2% - legs,kgs, basebase 20142014 DispositionsDispositions 4,9414,941 2015 Est. Dispositions 5,2515,251 2015 Est. Dispositions : AverageAverage 5,096 50%30% Inventory AllowanceAllowance 2,5482,548 ThankThanh you inin advanceadvance forfor consideringconsidering thisthis request. IfIf you require any additionaladditional information,information, please dodo not hesitate toto contactcontact me atat (b)(6)(b'<6) Best regards. ;b)(6)(b)(6) Director,[rector, Controlledontro SubstanceU•S ce Campomplianceiance Page 9 of 20 CONFIDENTIAL BUSINESS INFORMATION Vol. I Page 892 ProcurementProcurement andand ManufacturingManufacturing QuotaQuota IncreaseIncrease RequestRequest —-(b)(4)(b)<4) (b)(7)(E)(b)(7)(E) CPSCPS MorphineMorphine (9670),(9670), CPSCPS CodeineCodeine (9670),(9670), MorphineMorphine forfor ConversionConversion (9300),1300), MorphineMorphine forfor SaleSale (9300)(9300) andand CodeineCodeine forfor SaleSale (9050)(9050) MayMay 14,14, 20152015 AppendixAppendix AA MorphineMorphine andand CodeineCodeine ProcessProcess LossLoss InformationInformation APPENDIXAPPENDIX AA-I-I CPS-CPS- MorphineMorphine RequirementsRequirements andand MorphineMorphine Production,Production, kgkg BASEBASE PROCESSPROCESS LOSSESLOSSES BASEDBASED ONON 20142014 ESTIMATEESTIMATE WITHWITH YIELDSYIELDS FORFOR CURRENTCURRENT GRANTGRANT ADDITIONALADDITIONAL QUOTAQUOTA NetNet LossLoss InputInput LassLoss InputInput toto ProcessProcess outputoutput ofof byby toto OutputOutput byby Description Step Description Step YieldYield stepstep stepSt*! StepStep ofof StepStep step*{g> CPSCPS-AMA-AMA RequirementsRequirements CPSCPS-AMA-AMA toto MorphineMorphine forfor SaleSale 22,63622,636 86.35%86.35% 19,54619,546 7,4747,474 6,4546,454 CPSCPS-AMA-AMA toto MorphineMorphine forfor ConyConv 7,6577,657 85.64%85.64% 6.5576,557 20,36720367 17,4431 7,443 TOTALTOTAL CPSCPS-AMA-AMA ImBkgB 30,29330393 _27,84227342 1 StandardStandard processingprocessing yieldsyields areare usedused toto determinedetermine output_output . APPENDIXAPPENDIX AA-Z-Z MorphineMorphine forfor SaleSale 20I52015 ProductionProduction andand EstimatedEstimated ProcessProcess Loss,Loss, kgkg BASEBASE PROCESSPROCESS LOSSESLOSSES BASEDBASED ONON 20142014 ESTIMATEESTIMATE WITHWITH YIELDSYIELDS FORFOR CURRENTCURRENT GRANTGRANT ADDITIONALADDITIONAL QUOTAQUOTA NetNet of Inputpu t InputInput toto ProcessProcess LossLoss OutputOutput LossLoss DeriDescription tion outoutputput of Intoto , StepStep YieldYield by stepstep ofof StepStep by stepstep stepstep StepStep MorphineMorphine forfor SaleSale MorphineMorphine toto MorphineMorphine SulfateSulfate 19,54619,546 80.13%80.13% 15,66215,662 (3,884)(3,884) 7,6427,642 6,1246,124 (1,518)(1.516) MorphineMorphine SulfateSulfate FinishingFinishing 15,66215,662 99.70%99.70% 15,61515,615 (47)(47) 6,1246,124 6,1056.105 (18)(18) TotalTotal _ (3,931)(3.931) (1,537) - (1.337) Page 1010 of 20 CONFIDENTIAL BUSINESS INFORMATION Vol. I Page 893893 ProcurementProcurement andandManufacturing ManufacturingQuota Quota IncreaseIncreaseRequest Request ---(b)(!b)(4);(b)(7)(E)4) (b)(7)(E) I CPSCPSMorphine Morphine (9670),(9670),CPS CPS CodeineCodeine (9670),(9670), MorphineMorphinefor forconversion ConversiorT(9300),(,wuO), Morphine Morphinefor for SaleSale (9300)(9300) andandCodeine Codeine forfor SaleSale (9050)(9050) MayMay 14,14, 20152015 APPENDIXAPPENDIXA-3 A-3 CodeineCodeine forfor SaleSale (Morphine)(Morphine)2015 2015Production Production andand EstimatedEstimatedProcess Process Loss,Imss,kg kgBASE BASE PROCESSPROCESS LOSSESLOSSES BASEDBASED ONON,20142014 YIELDSYIELDS FORFOR ESTIMATEESTIMATE WITHWITH CURRENTCURRENT GRANTGRANT ADDITIONALADDITIONAL QUOTAQUOTA NetNet LossLoss InputInput toto ProcessProcess output byby InputInput toto Output LossLow byby DescriptionDescription StepStep YieldYield MWCMWC ofofstep step stepstep► Step ofof StepStep stepstep CPS-AMACPS-AMA toto MorphineMorphine forfor ConvCony 15.72015,720 85.64%85.64% 13.46313,463 13.30412,304 10.53710,537 CodeineCodeine forfor SaleSale MorphineMorphine forfor ConvCony toto CodeineCc seine forfor SateSale 13,493 88.8%88.8% 1.051.05 1238112,581 9,5669,566 8,9198,919 Codctitc(frCodeine(fr Morph) toto Codeine Phosphate 12,581 93.60%93.60% 11,77611,776 (805) 9,4229,422 8,8198,819 (603)(603) CodeineCodeine PhosphatePhosphate FinishedFinished 11,77611,776 99-28%99.29% 11,691 (85)(85) 8,9038,903 8,8398,839 cf.:4) Total (890) (667) Total _ I ...I- __ (890) (667) APPENDIXAPPENDIX A-4 Codeine forfor Sale (Tasman)(Tasrnan) 20152015 Production and Estimated Process Loss, kg BASE PROCESS LOSSESLOSSES BASED ON 20142014 YIELDSYIELDS ESTIMATEESTIMATE WITHWITH FORFOR CURRENT GRANT ADDITIONAL QUOTA NetNet LossLoss Input • Process output by toto Output Loss by Description InputInput toto Step Yield of step , step Step of Step step 4,188 3.050 2,562 CPS-ACACPS-ACA toto Codeine forfor Sale 4,9864.986 84.0% 4,188 3,450i 2,562 Codeine forfor Sale r Codeine(fr CPS) to Codeine Phosphate 4,188 87.8% 3,677 (511) , 2,692 2364 (328) Codeine Phosphate Finished 3,677 99.3% 3,650 1261(26) 2,364 23472,347 (17) Total (537) _ (346) Page 11II of 20 CONFIDENTIAL BUSINESS INFORMATION Vol. I Page 894 Procurement and Manufacturing Quota Increase Request -pX4)—(b)(4) (b)(7)(E) I CPS Morphine (9670), CPS Codeine (9670), Morphine for Conversion (9300),( 300), Morphine for SaJeSale (9300) and Codeine for Sale (9050) . May 14,14,2015 2015 ' " Appendix B Purchase Orders (b)(4)[b)(4);(b)(6) (b)(6) Page 1212 of 20 CONFIDENTIAL BUSINESS INFORMATION Vol. I Page 895895 , ProcurementProcurement andand ManufacturingManufacturing QuotaQuota IncreaseIncrease RequestRequest —~ft>)ffl;(b)(7)(E) b)(4) (b)(7)(E) I • CPSCPS MorphineMorphine (9670),(9670), CPSCPS CodeineCodeine (9670),(9670), MorphineMorphine forfor ConversionConversion (93(93UU), ), MorphineMorphine forfor SaleSale (9300)(9300) andand CodeineCodeine forfor SaleSale (9050)(9050) MayMay 14,14, 20152015 AppendixAppendix BB PurchasePurchase OrdersOrders (b)(4)(b)(6)b)(4)Kb)(6) Page 1313 of 20 CONFIDENTIAL BUSINESS INFORMATION Vol. I Page 896896 ProcurementProcurement andand ManufacturingManufacturing QuotaQuota IncreaseIncrease RequestRequest _,(b)(4)-|(b)ffl,(b)(7)(E) (b)(7)(E) | CPSCPS MorphineMorphine (9670),(9670), CPSCPS CodeineCodeine (9670),(9670), MorphineMorphine forfor ConversionConversion (9300),(9300), MorphineMorphine forfor SaleSale (9300)(9300) andand. CodeineCodeine forfor SaleSale (9050)(9050) MayMay 14,14, 20152015 AppendixAppendix 13B PurchasePurchase OrdersOrders (b)(4)(b)(4);(b)(6) (b)(6) Page 1414 of 20 CONFIDENTIAL BUSINESS INFORMATION Vol. I Page 897 ProcurementProcurement andandManufacturing Manufacturing'Quota Quota IncreaseIncreaseRequest Request -|W(4);(b)(7)(E)|— b)(4) (b)(7)(E) CPSCPSMorphine Morphine (9670),(9670), CPSCPSCodeine Codeine (9670),(9670),Morphine Morphinefor for ConversionConversion(9300), 9300),Morphine Morphinefor for SaleSale (9300)(9300) andandCodeine Codeinefor for SaleSale (9050)(9050) MayMay 14,14, 20152015 AppendixAppendix BBPurchase Purchase OrdersOrders ' (b)(4);(b)(6);(b)(7)(E)(b)(4) (b)(6).(b)(7)(E) Page 1515 of 20 CONFIDENTIAL BUSINESS INFORMATION Vol. I Page 898898 Procurement and Manufacturing Quota Increase Request -—(b)(4)(b)ffl;(b)(7)(E) (b)(7)(E) CPS Morphine (9670), CPS Codeine (9670), Morphine for Conversion (9300), Morphine for Sale (9300) endand Codeine for Sale (9050) May 14, 2015 . Appendix B Purchase Orders ' (b)(4)(b)(4);(b)(6);(b)(7)(E) (b)(6) (b)(7)(E) rktgcrage iuj.o U1ui Artixm CONFIDENTIAL BUSINESS INFORMATION Vol. I Page 899 ProcurementProcurement andandManufacturing ManufacturingQuota QuotaIncrease IncreaseRequest Request-|(b)ffl:(b)(7)(Er — (b)(4) (b)(7)(E) • CPSCPS MorphineMorphine(9670), (9670), CPSCPSCodeine Codeine(9670), (9670),Motphinefor Morphine for ConversionConversion (9300),(9300), MorphineMorphinefor for SaleSale (9300)(9300)and and CodeineCodeinefor for SaleSale (9050)(9050) ' MayMay 14,201514, 2015 AppendixAppendixB BPurchase Purchase OrdersOrders • ' . (b)(4);(b)(6);(b)(7)(E)(b)(4) (b)(6),(b)(7)(E) Page 1717 of 20 ' CONFIDENTIAL BUSINESS INFORMATION Vol. I Page 900 ProcurementProcurement andandManufacturing ManufacturingQuota QuotaIncrease IncreaseRequest Request-—|(b)(4);(b)(7)(E)(b)(4) (b)(7)(E) CPSCPSMorphine Morphine (9670),(9670), CPSCPSCodeine Codeine(9670), (9670), MorphineMorphine forforConversion Conversion(9300), (9300),Morphine Morphinefor for SaleSale (9300)(9300) andand CodeineCodeine forforSale Sale (9050)(9050) . ' • MayMay 14,14, 20152015 ; . . AppendixAppendix S8Purchase Purchase OrdersOrders '' (b)(4);(b)(6);(b)(7)(E)(b)(4) (b)(6) (b)(7)(E) Page 1818 of 20 CONFIDENTIAL BUSINESS INFORMATION Vol. I Page 901 Procurement and Manufacturing Quota Increase Request -|(b)ffl- (b)(4) (b)(7)(E)(bX7XE) CPS Morphine (9670), CPS Codeine (9670), Morphine for Conversion (9300), Morphine for Sale (9300) and Codeine for Sale (9050) May 14,14,2015 2015 Appendix B Purchase Orders ' . ' . ' (b)(4)(b)(4);(b)(6);(b)(7)(E) (b)(6) (b)(7)(E) Page 19 of 20 CONFIDENTIAL BUSINESS INFORMATION Vol. I Page 902 b)(4) ProcurementProcurement andand ManufacturingManufacturing QuotaQuota IncreaseIncrease RequestRequest--X-|(b)<4):(bK7) (b)(4)(b)(4);(b)(7)(E) (b)(7)(E) Page 20 of 20 CONFIDENTIAL BUSINESS INFORMATION Vol. I Page 903 /-) n 201520 IS FiribmidR«vsM»d APOAPQ Beale Clark WM-09601-0 WoriceavbenWafcohMta ra78441IMA..P12Total(CU»PT?): 1,131,0040001.131.004400 FDAFDA Ee:Erf: •.000 MSIKS EstEst ..0-41 GoirrporrfCompany DEAOCA MumHim 2062CH 100MQ R./ 0w 20151102015 MO 20142014 Za4=4$•*« =14W14 T84.41Tt*^ Ss'.Alia* %*«f20l4S»J»« of 2614 Soh. Shag*Sti*M 44of 20167016 TaalTc4«l POPQ 217142«14 Imvertrorybw»«to»y 20152015 P764.7144PM**-* ExportsLxpctU C4181.14u7pC*fc IMiftfl CATIcm V%*rtt 1716.edh**nt CaleCatelMngCFRf0%lAVM« Wm CFR 50%18.2•82 P0.2Rn»l»|Q MO (b)(4).(b)(7)(E)(b)(4);(b)(7)(E) 5.0005000 6.0006.000 0.0000.000 1,120,169.4871.180.160.467 06000.000 0000'0.000' 0.100C.100 0.000O.DOO 43,1000.100 -0-0.(00.100 ooxo0.000 500,000.000200,000 000 1sa,e,es1 S3,609 cooCOO Ita39.013.000-13.000 1,5)0,169.41371,100,169.447 00330033 37.633.02437.BMB24 55,605.0005S.6O5.O0O 00000-000 -6621.C60•4.03 1.0» 1,440.6301.440.930 0=00 000 • 216,090.000216.000.000 136.000.000136.003 COO 512.080.000112.000.0*1 1,100,160.4671,180.180.487 00940.094 100500301toe.soe.301 6,7101106,740.110 100,062000ieo,ooo.ooo 311,720662S11.7W.6d2 334,415267334.4 1&267 0.0000 000 4000 co:00 20002.000 20002000 04670.46? 1,100,162.4671,190.188.467 0000aooo 0.4140.444 2.2622282 0.000 -1,705•I.70S •11111•1.911 0.000 13,130.03313.330000 Ickeactcuo10.(MO.000 10.17110010.174.000 1,1/0,1514671,120,183.467 00093009 6.0107320,608.732 2,503.0002,503 000 0=0C-000 10,0667=10.MS.7Q2 /2,126.7P612.12&760 0,0030.000 440,003000600,000.003 618.605_0WS 16.605 000 773,tos273. ICS 000000 1,190,109.4871,190.1 OB 487 02290229 259.520459258.520.459 387,124.000307,124 000 0.000O.OOO -49.737.004-49.7J7.004 6,662.623S.S®4J3 0000O.OOO 990.030.000860X00. W 621.515,003631X15-000 736,6=1600738AMjOOQ 1,190.106,4471.190,199.467 0821OJDI 701,610,225701.018-225 232,750000232.756X00 • 331,091.090331 .061.000 1,010,620.0031.010.Q20803 1,1130.384.6571,160.334. 0W 0000O000 3,033.0003.033.000 *LIMO0X03 0.coa0.000 1,160060,4871. 160.160.407 0000aooo 0003aooo 0_0000X00 00030400 00000000 .. -0.0030400 0003aooo 43,003.00043X00.000 29,00030025,000.000 16,359.00016,356.000 1.180.5&34671.190.109.467 60110014 15.544,61115.544.914 14,100=014,100.000 0.000O.OOO 9048.2599.040.259 935715168460.519 00000 000 13,500-00013X00-000 00000.0OO 00000J»0 1,190.1694671,190.160.467 00000X00 006/0O.OOO 0000o.oco 0.0000.000 • 00000000 00000 000 0=00000 110MQTcuhk! Tc4414, 2,077,637.0002,077.637.000 1,675,748=01,675,746X00 1,190,169.4671,180,168.487 1396,090.492689,090.462 511,081.000si 1,081 .000 1262.295,706u«2.28l.706 0000O.OOO FIns1Hn.l InitialInitial APO:APO; 1,720,000.0001,720.000 000 Propem4dPropo*«d Ra444.86, 1,640,000.0001.940.000 000 ProposodPnjpo«#d Ft.erisadFUtt^0 (64th(»r+th 25Y.25* buffer):butfar): 2,500,000.0002X08.080 000 FoalRralfWvWdAPO: R.'M.d APO: 0000OCCO UGN..4=Hwd=pcr-PIT 1.5IX -- HQ-Invenfory:- bwwiwr- -670330.492979.330.492 CFRCfflSO*: 80% 4163.539.125963.Sa9.f2S 20142014 InitialUwti«l APO:APO; 70670000001.M7.000 000 FDAFDA Eat=Eat - 20142014 A1APQ, 0 •• (1• FDAFOA Est},E«7 1.670,5401,676.540 000OOC 1148IMS Eel,E«i<- 20142014 APOAPQ •1 (1(1 • 114sIMS Es*E*tp 1,699,961.3001.699X61.300 Pendlno1.418•818Ponding hMfuaala V60,from; CornparrrComp*fry DEADCANui*i Mum 2015110MISUORaquaai i7,4quest carr4r4currant /AOMX p644.04.4powftHflrtt grolt dHhranca (b)(4)(b)(4);(b)(7)(E) (b)(7)(E) 690880.000 6 00 000000 031,515831.S1S.000 COO 990000/100990.000.0® 158,4650001S0.49S.OOO (rut(rat 09 123253;123233; sholidshoJd bet>e grantottgrantod 159kg158kg butbut limitedHmrted toto 404tg40kg byty APO)APQ) 3,000.0003,000 OOO 00000000 400400.000 000 sop400 603ooo (ref(ref 09 123549;123549; grantedgranlod .4kg).4kg) 115,8851 is.aasooo 00310141ictal 1054.000l_2M.ooo rernaisOn9remaining APOAPC Ve&ITAmtiveiirAHu L( Vol. I Page 904 c r r 2 8 2315 R.714ed APQ i * a s£ 1 Worlaheeis Beek CIA.: 314341 S3 sS i s 2 1 5 P0 ne61101.4P0): 67,645,603.013 F0A £45 ..011 643 E.t .012 • si§ll§§ll§§l joodcooooo'ob I I s * i 5 5 elSg§lsS2|s2 i 5 ! ? 3 3 * I 5 S « 8 ?SSsil§s231i I ! g a 8 l ]«!!: i JnoOOOOOcjaoo SS8I11SI§§§§ tsil§§§§§§§§§ 8 o r-riU^s " I 181888888888 i * 8 .gUllllllli g f®8§l|||8§|§ t 2013 Total PO 2014 7716 Prolected Export. c.ie WON CFR 30%111'44,4 Col‘ W CFA 5011, Smart Simi 60:1 Stales .A012014 Salad mare of 61.. rimy « 2018140 Saiee 2014 Totel ooOQddon g CrEAAure 2016 1a0 Y140,..al 2014 ^ggo° §§§§§§§§111 -ig°°ES|°§i5 s Co.c0,0 6 p S* 1H £ 0.001 1,035 0.000 .1.67.5 -1.035 0.003 2 10000 10.072 0030 75,1 72.840.417 01:00 2 "2 1 ' kb)(4) (b)(7)(E) *' 000019 0.000 •790.153 -184729 0.000 7.547 § 1 65200 60000 6.417 75,172.040.417 00:0 = = 1 1 3 immI * « mnrn 116.390.700 0000 101,535830 245,006787 0.002 0004 238.010 231 * 2 A.M, X0 AOC 4.642.015000 201,726.000 76,172/M0.417 1 * g 8 0030 0.030 0,000 0.000 0.500 0000 0.000 ° 100,033 000 100.000.005 0.030 n.172,040,417 1 § * 8 » 0.000 0,000 0.000 0 000 0.000 0.003 - i S. g im- S22 5,100,000000 1,150,000.003 0.002 76,172640.417 0.000 - MS s - i gig 8 W y| 364,673.000 0.200 1,166,670 092 1,457767,171 0700 5 || 1,193 al 1 .80e * a 4,050,000.000 2,460,622 1550 1.322,366700 75,172,840.417 02110 v :• 5 S * HM8 o 6,902,467.510 14,546,073000 -5,493,006.737 3.913,307.163 0.002 0.000 3 B 4 16.00000.000 16,900,000 000 7,7 I4,405,000 75.172,840.417 0.103 2 2 §. | W 0.000 14.749.253,293 45,410,577.743 0.000 19,572,710000 ° 60,003,000.000 75,470,000.000 47,157246.000 75,172840.411 0,827 42.600.740.020 I - ° t 0.000 2000 0.000 0000 0.000 5 U 0.530 8 M | 0.000 0.070 I? 2000050 2.000.000 75.177040.417 r M » s ff » i m Is' m J 16,231599.360 33371532000 4,200,000000 16,033,147.104 20,400,414.075 0.000 0241 = 10.34/1.003.030 14.300.003003 10,036.001.000 76.172840,417 ; g M 4,016,000.000 2,510.0004{40 0 0700 000 75.172,840.417 0.008 550296.681 P71.934.000 0.000 104,101.696 231,111652 0.000 I © g 9 } I S 8 ; 5 2 § 5 s I 1 f § 1 I r~ I a 5 1.10 704414: 123633,070000 100037,707000 75,172,040417 44 569,513684 4,330,003 411.4 .770.27,7 0.000 If 55g 18 t IE 1 Fl nal Mal &PO: 110,003,000.000 6 3 5 3 & 5 si Proposed P•v1440: 111.320.000.300 (1%45 pct chg., § g I I - f 5 Prrixeed FI•vleed (with 21% W040. 139.150,000.000 | ° 1 iH§§ | RAO 1 Bev iaad APO: cow 5 8 e 1 1 iP mm ?2*8 I I I 1 1 I 1 • 1110NeedaP0/ 1,5- liey{sodh03 . inventory: 49,774,603AM / CFA 501: -47,007.030 VA H 8 1 2011 Initial APO, 110 603.000,020 SJ 23 ! 1 *1 s ?! SCASS 6.1.17014 WO • (1 . FOA 117,149.007.003 § 1 a 14:3 Est = 2014* APQ Ists (ea): 120,031 500.000 I I Pending flaq.sks: 1=1 Hi lit ill a Hi 5 3=3 1 i 5 COW CEA 71.4rn 2015140 Requ4al cort.01110 pos.1014 gren1 ddlereno• ii §1 §1 8 18 X c -Q o 5,100,000000 1,350053.000 5,100,000.000 3.762.000000 § (b)(4) (b)(7)(E) 8 17.536.700.000 14,303.000000 17.270,003.003 3001,000 000 § I 6,717,000.000 I § i 3 1 3,062,293.030 current avalabla APO I x> i I a 3,654,707.000 000(0106 i 8 B o u> o s OXYCODONE FOR SALE) js °- o d> . 18.18418.184 881,350.945881 ,350.943 )2'1- 102,201.000 2,273.000 " 5,110 454.600454.600 37.92237.922 2.2782.278 181,625.113181,525.113 15,240.5001 5,240.500 171,313 C 6,705.350 & 512.370512.370 ^7^050 7.4657.465 _ _ 229.067 ~ Y4040,923.092 923.092 D I'A aero 26.385 27.462 C-7 2_ 0 • 991.529 'J 1 TZ O _ . 290.035 Grand Total 1,314,839.6171,314,839^617 )4° LL b)(4 OXYCODONE SALES pjARCOSRCOS 2014 (2) *N Vol. I Page 906 ni 20152015K©v»** Compeer, DEAOEAFfcn gum 2016mbmiU<|UM] KO Recluse 2016TO16UQ SAO 20142D14&41M 540ss 2014»1 4 TotalT<*«l Soho6«»-* % of 2014 9.1.4 Shave at 20157400Total P0PO 2014201 4 Inseertoryln»ootofy 2016701 6 ProlectedPro^cMf ExportsExpo*. tailCaic thingIHing CFRCFB 29%*7* InventItvmI C.lcCMc 9.190tMhic CRScm 501Ewm Irmo/brr»f* FlrolFhlftlQ 140 0.900 0.000 0.000 0 000 (b)(4)(b)(4);(b)(7)(E) (b)(7)(E) SoouS000 5.0005000 0.0300.000 ' 458.703450.700 0.0000.000 0.0000.000 O.OOO 00000.000 OOCC 0 030 0000 1,310.0001.30O0O0 1,155.0001 .356.000 D0000 OW 459,789459.789 0.000D.000 0.0030 000 0.0000000 a0000 coo 0.0000000 0.000O000 0.0000.000 5.0005.000 5.0005.000 0.0000000 45045S7A3 789 0.0000.000 0.000O.OOT 00000 000 00000 000 a0000.000 0.0000000 0.0030.000 1,320.0001.820.300 1,8200091.820 000 454.000450.000 459,789459.789 00980 996 2.074.4342.074434 2.055.0002.055000 0.0000000 841,784841.764 852.703652.793 0.000 10001.000 000000 0.0000.300 00000 000 459.789459 789 0.0000.000 0.0000.000 483.945483045 0.0000.000 483945-483.945 483.845-463.045 0.0000 000 5.0005.000 5.0005.000 0.7890.789 459.789459.789 0.0320.002 3.5683 566 0.0168.010 0.0000.000 48184818 4.8174.837 0.090c.oco 410MO Toteb:Touts; 4.1350004.135.000 2.590.0002.090.000 459.789459.769 2.530,9635.371.980 0.0000.000 182-437162.437 0.0000.000 FinalFinal klas1APOtInXUI APQ: 3003,0003,000 000 PropoeedProponed Aovired:fWviM* 3.35A.4033350 400 ProposedPropowd ReVieedRnWd (w00(wWi 25%25* t•r11•r):buff"): 4,185,0034.186 000 (4,200(<300 wourmingraving up)up) FlAstRaNheaKiRfu! JUW^APO; APO: 0.0000000 NOMQ Noe&No*fcPQ* PC1• 1.5-1.6- Rev144,1fl»vU*d MO-HQ- lerroniery:Ifr»«f4e*y: .2,411-2.411063 083 CFRCWW*: 60%: -2,818.515-2,810518 201420I4IOHMAPQ: Initlal AP4 3003.0003,000.000 FDAFDA Est,Eat c 20142014 APO«PO •• (1f| ♦4 FDAFDA Eat):EM): 3,172.2003,172.200 t*SII9S E.1Brt -20142014 APOAPQ "(1(1 .1149 EA4): 31113,111300 300 Pe.dirs2PmdinQ Rettosela:RequonJa: Ceregsmy DF_ADEAHtan 14i= 201530261$MQR**»*t Fisw4s•St 2015*>15 110UG (b)(4)Kb)(4):(b)(7)(E) (b)(7)(E) 1.3001 JOT 000000 1,155.0001.1 35 000 9000quota grantedgranted vla9waa 41101short 200g.230g: reftel tI 121501121501 REMREMIFENTANIL IFENTANIL Vol. I PagePage 907907 201S2015 ProposedProposed AdjustedAdjusted AggregateAggregate Production Quotas and Assessment of Annual Needs L Production Quotas and Assessment of Annual Needs • SectionSection 306(a)306(a) ofofthe the ControlledControlled SubstancesSubstances ActAct (CSA)(CSA) requiresrequires thetheAttorney Attorney GeneralGeneral toto establishestablish limitslimits onon thethe productionproduction ofof schedulesschedules II andand IIII controlledcontrolled substances.substances. ThisThis responsibilityresponsibility hashas sincesince beenbeen delegateddelegated toto thethe AdministratorAdministratorof ofthe the DrugDrug EnforcementEnforcement AdministrationAdministration (DEA),(DEA), whowho hashasre- re- delegateddelegated thisthis responsibilityresponsibility toto thethe DeputyDcputy AdministratorAdministrator ofof thethe DEA.DEA. •• TheThe attachedattached FederalFederal RegisterRegister notice,notice, preparedprepared forfor youryour signature,signature, proposesproposes toto adjustadjust thethe calendarcalendar yearyear 2020151 5 aggregateaggregate productionproduction quotasquotas ((APQ)APQ) forfor eacheach basicbasic classclass ofofschedule schedule II andand IIII controlledcontrolled substancessubstances andand assessmentassessment ofof annualannual needsneeds (AAN)(AAN) forfor thethe listlist II chemicalschemicals ephedrine,ephedrine, phenylpropanolamine,phenylpropanolamine, andand pseudoephedrinepseudoephedrine forfor whichwhich thethe UnitedUnited StatesStates hashas medical,medical, scientific,scientific, industrial,industrial, export,export, andand reservereserve stockstock requirements.requirements. ' •• AsAs statedstated inin thethe 20132013 FederalFederal RegisterRegister Notices,Notices, DEADEA continuescontinues toto addadd anan additionaladditional 25%25% toto thethe APQAPQ forfor scheduleschedule IIII substancessubstances andand thosethose scheduleschedule II substancessubstances thatthat areare usedused toto produceproduce drugsdrugs thatthat havehave aa medicalmedical needneed (specifically,(specifically, GHBGHB andand tetrahydrocannabinols)tetrahydrocannabinols) toto preventprevent potentialpotential drugdrug shortageshortage issues.issues. , •• TheThe FederalFederal DrugDrug AdministrationAdministration (FDA)(FDA) hashas respondedresponded toto DEA'sDEA' s annualannual letter,letter, whichwhich requestsrequests informationinformation on new,new, continuing,continuing, and discontinueddiscontinued drugdrug productsproducts containingcontaining schedule IIII substances. Therefore,Therefore, thisthis informationinformation isis considered inin thethe analysis forfor thethe current proposedproposed adjustments. ExpeditiousExpeditious reviewreview andand publicationpublication ofof thisthis noticenotice isis necessarynecessary toto ensure anan uninterruptableuninterruptable supplysupply of L'L • schedule II andand IIII controlledcontrolled substances asas wellwell asas listlist II chemicalschemicals ephedrine,ephedrine, phenylpropanolamine,phenylpropanolamine, andand pseudoephedrinepseudoephedrine forfor thethe legitimatelegitimate medical,medical, scientific, industrial,industrial, and exportexport requirementsrequirements ofof thethe U.S.U.S. • The following points provide brief explanations of the changes from the proposed initial AAN & APQ values: List 1 chemicals • No changes proposed. Schedule II substances • The APQ for (1-Penty1-1H-indol-3-y1)(2,2,3,3-tetramethylcyclopropyl)methanone(l-Pentyl-lH-indol-3-yl)(2,2,3,3-tetramethylcycIopropyl)methanone (UR-144), 11-(5-Fluoro-penty1)-1H-indo1-3-y11(2,2,3,3-tetramethylcyclopropyl)methanone[l-(5-Fluoro-pentyl)-lH-indol-3-yI](2,2,3,3-tetramcthylcyclopropyl)methanone (XLR11), 1- (1,3-Benzodioxo1-5-y1)-2-(methylamino)butan-l-one(l,3-Benzodioxol-5-yl)-2-(methylamino)butan-l-one (butylone), 1-(1,3-13enzodioxo1-5-y1)-2-l-(l,3-Bonzodioxol-5-yl)-2- (methylamino)pentan-1-one(mcthylamino)pentan-l-one (pentylone), 2-(4-Bromo-2,5-dimethoxyphenyl)-N-(2- mcthoxybenzyl)ethanamine (25B-NBOMe; 2C-B-NBOMe; 25B;2513; Cimbi-36), 2-(4-Chloro-2,5- dimethoxypheny1)-N-(2-methoxybenzyDethanaminedimethaxyphenyl)-N-(2-methoxybenzyl)ethanaminc (25C-NBOMe; 2C-C-NBOMe; 25C; Cimbi-82), 3-Fluoro-N-methylcathinone (3(3-FMC),-FMC), 4-Fluoro-N-methylcathinone (4(4-FMC),-FMC), 4- Methyl-N-ethylcathinone (4-MEC), 4-Methyl-a-pyrrolidinopropiophenone (4-MePPP),(4-MePPP), alpha-aJpha- Pyrrolidinobutiophenonc (a(a-PBP),-P1311), alpha-Pyrrolidinopentiophenoncalpha-PyrroIidinopentiophcnonc (a-PVP), Desomorphine, N-(1-Adamanty1)-1-penty1-1H-indazoIe-3-carboxamideN-(l-Adamantyl)-l«pentyl-lH-indazoIe-3-carboxamide (AKB48), N-(l-Amino-3,3-dimethyl-l- OD/ODQ/ODEQ 5/19/15 Page - I1 -• of 2 Vol. I Page 908908 oxobiitan-2-yl)-l-pentyl-lH-iiidazo[e-3-carboxamideoxobutan-2-yl)-1-pentyl-1H-indazole-3-carboxamide (ADB-PINACA),(ADB-PINACA), N-(l-Amino-3-methyl-l-N-(1-Amino-3-methyl-1- LL oxobutan-2-yI)-I-(4-ftuorobenzyI)-lH-indazoIe-3-carboxamideoxobutan-2-y1)-1-(4-fluorohenzy1)-111-indazole-3-carboxamide (AB-FUBINACA),(AB-FUBINACA), NaphthylpyrovaleroneNaphthylpyrovalerone (naphyrone),(naphyrone),QuinoIin-8-yl Quinnlin-8-y1 l-(5-fluoropentyI)-lH-indole-3-carboxylatc1-(5-fluoropenty1)-1H-indole-3-carboxylate (S-fluoro-PB-22;(5-fluoro-PB-22;5F-PB-22), 5F-PB-22), QuinoIin-8-yIQuinolin-8-yll-penty1-1H-indde-3-carboxylatel-pentyl-lH-indole-3-carboxyIate (PB-22;(PB-22; QUPIC),QUPIC), Heroin,Heroin,Normorphinc, Normorphine,and and Tilidine,.Tilidine,. TheThe manufacturingmanufacturing ofofthese thesesubstances substanceswill will bebe usedused forfor analyticalanalytical 'standards,standards, reference,reference, andand researchresearch material.material. NewNew DEADEA registrant(s)registrant(s) enteringentering thethe referencereference standardstandard marketmarket atat thethe bulkbulk manufacturingmanufacturing level.level. •• TheThe APQAPQ forfor Para-Fluorofentanyl,Para-Fluorofentanyl, Parahexyl,Parahexyl, andand PholcodinePholcodine werewere increasedincreased fromfrom 2erozero duedue toto requests'requests'to to manufacturemanufacture thesethese substancessubstances forfor analyticalanalytical standards,standards, reference,reference, andand researchresearch material.material. \ •• TheThe APQAPQ forfor TetrahydrocannabinolsTetrahydrocannabinols waswas increaseincrease duedue toto increasedincreased productproduct developmentdevelopment effortsefforts byby DEADEA registeredregistered manufacturers.manufacturers. . ScheduleSchedule IIII substancessubstances •• TheThe APQAPQ forfor Dextropropoxyphene,Dextropropoxyphene, Levomethorphan,Levomethorphan, Meperidine-IntermediateMeperidine-Intermediate B,B, andand PhcncyclidinePhencyclidine werewere increasedincreased duedue toto increasedincreased registrantregistrant requirements.requirements. TheThe manufacturingmanufacturing ofof thesethese • substancessubstances willwill bebe usedused forfor analyticalanalytical standards,standards, reference,reference, andand researchresearch material.material. NewNew DEADEA registrant(s)registrant(s) enteringentering thethe referencereference standardstandard marketmarket atat thethe bulkbulk manufacturingmanufacturing level.level. •• TheThe APQAPQ forfor CodeineCodeine (for(for sale)sale) isis proposedproposed toto increaseincrease basedbased onon analysisanalysis ofof IMSIMS HealthIlealth Data,Data, whichwhich shows anan increaseincrease inin prescriptionprescription salessales thatthat appearsappears toto coincidecoincide withwith thethe reschedulingrescheduling ofof FDAFDA caw, approvedapproved hydrocodonehydrocodone productsproducts fromfrom schedule IIIIII toto schedule .. • TheThe APQAPQ forfor FentanylFentanyl isis proposedproposed toto increaseincrease basedbased onon aa DEADEA registeredregistered bulkbulk manufacturer'smanufacturer's improvementimprovement of theirtheir synthesissynthesis routeroute toto manufacturemanufacture fentanylfentanyl fromfrom ANPP.ANPP. ' • The APQ forfor Methylphenidate isis proposedproposed toto increaseincrease basedbased on thethe FDA downgrading thethe efficacy ratingrating forfor twotwo generic manufacturers of thethe brand Concerta® . This change isis toto allow thethe remainingremaining authorized generic and brand manufacturers toto supply thethe entire domestic market. This will avert a ^, possible shortage due toto APQ limitations.limitations. • TheThe APQAPQ forfor Oxycodone (for sale) isis proposedproposed toto increaseincrease basedbased on additional productproduct development efforts as dosage formform manufacturersmanufacturers qualify a second supplier of API as requiredrequired byby thethe FDA.FDA. • The APQ for Remifentanil was increased due to new applications from registrants conducting bulk API product development efforts or supporting dosage form manufacturers in dosage form product development efforts. ^ OD/ODQ/ODEQ 5/19/15 Page-Page - 2 --of of 2 Vol. I Page 909 BILLINGBILLING CODECODE 4410-09-P4410-09-P L DEPARTMENTDEPARTMENT OFOF JUSTICEJUSTICE DrugDrug EnforcementEnforcement AdministrationAdministration IDocketNo.pocket No. DEA-411|DEA-4111 ProposedProposed AdjustmentsAdjustments toto thethe AggregateAggregate ProductionProduction QuotasQuotas forfor ScheduleSchedule II andand IIH ControlledControlled SubstancesSubstances andand AssessmentAssessment ofof AnnualAnnual NeedsNeeds forfor thethe ListList .II ChemicalsChemicals Ephedrine,Ephedrine, Pseudoephedrine,Pseudoephedrine, andand PhenylpropanolaminePhenylpropanolamine forfor 20152015 AGENCYAGENCY:: DrugDrug EnforcementEnforcement AdministrationAdministration (DEA),(DEA), DepartmentDepartment ofof Justice.Justice. ACTION:ACTION: NoticeNotice withwith requestrequest forfor comments.comments. SUMMARY: The Drug Enforcement Administration proposes toto adjust thethe 2015 aggregate production quotas for several controlled substances in schedules I and II of thethe L Controlled Substances ActAct and assessment of annual needsneeds forfor thethe listlist II chemicals ephedrine, pseudoephedrine,pseudoephedrine, and phenylpropanolamine.phenylpropanolamine. DATES: . Interested persons may filetile written comments on this notice in accordance with 21 CFR 1303.11(c)1303.1 1(c) and 1315.1I315.11(d).1(d). Electronic comments must be submitted, and written comments must be postmarked, on or before [INSERT 30 DAYS AFTER PUBLICATION IN THE FEDERAL REGISTER]. Commenters should be aware that the electronic Federal Docket Management System will not accept comments after midnight Eastern Time on the last day of the comment period. ADDRESSES:ADDRESSES; To ensure proper handling of comments, please reference "Docket No. DEA-411"DEA-41 1" on all electronic and written correspondence. The DEA encourages that all comments be submitted electronically through the Federal eRulemaking Portal at http://www.regulations.gov. Paper comments that duplicate electronic submissions are Vol. I Page 910 LL notnot necessary.necessary. ShouldShould you,you, however,however, wishwish toto submitsubmit writtenwritten commentscomments viavia regularregular oror expressexpress mail,mail, theythey shouldshould bebe sentsent to:to: DrugDrug EnforcementEnforcement Administration,Administration, Attention:Attention: DEADEA FederalFederal RegisterRegister Representative/ODW,Representative/ODW, 87018701 MorrissetteMorrissette Drive,Drive, Springfield,Springfield, VirginiaVirginia 22152.22152. FORFOR FURTHERFURTHER INFORMATIONINFORMATION CONTACT:CONTACT: JohnJohn R.R. Scherbenske,Schcrbenske, OfficeOffice ofof DiversionDiversion Control,Control, DrugDrug EnforcementEnforcement Administration,Administration, 87018701 MorrissetteMorrissette Drive,Drive, Springfield,Springfield, VirginiaVirginia 22152,22152, Telephone:Telephone: (202)(202) 598-6812.598-6812. SUPPLEMENTARYSUPPLEMENTARY INFORMATION:INFORMATION: PostingPosting ofof PublicPublic CommentsComments AllAll commentscomments receivedreceived areare consideredconsidered partpart ofof thethe publicpublic recordrecord andand willwill bebe mademade availableavailable forfor publicpublic inspectioninspection onlineonline atat http://www.regulations.gov.http://www.regulations.gov. SuchSuch informationinformation address, etc.) voluntarily LL includesincludes personalpersonal identifyingidentifying informationinformation (such(such asas youryour name,name, address, etc.) voluntarily submittedsubmitted byby thethe commenter.commenter. TheThe FreedomFreedom ofof InformationInformation ActAct (FOIA)(FOIA) appliesapplies toto allall commentscomments received.received. IfIf youyou wantwant toto submitsubmit personalpersonal identifyingidentifying informationinformation (such(such asas youryour name,name, address,address, etc.)etc.) asas partpart ofof youryour comment,comment, butbut dodo notnot wantwant itit toto bebe mademade publiclypublicly available,available, youyou mustmust includeinclude thethe phrasephrase "PERSONAL"PERSONAL IDENTIFYINGIDENTIFYING INFORMATION"INFORMATION" inin thethe firstfirst paragraphparagraph ofof youryour comment.comment. You must alsoalso place allall thethe personal identifyingidentifying informationinformation you dodo not want mademade publiclypublicly availableavailable inin thethe firstfirst paragraphparagraph ofof youryour commentcomment andand identifyidentify whatwhat informationinformation youyou wantwant redacted.redacted. IfIf youyou wantwant toto submitsubmit confidentialconfidential businessbusiness informationinformation asas partpart ofof youryour comment,comment, butbut dodo notnot wantwant itit toto bebe mademade publicly available,available, youyou mustmust includeinclude thethe phrase L "CONFIDENTIAL"CONFIDENTIAL BUSINESS INFORMATION" in the first paragraph of your 22 Vol. I Page 91191 1 L comment.comment. YouYou mustmust alsoalso prominentlyprominently identifyidentify thethe confidentialconfidential businessbusiness informationinformation toto bebe redactedredacted withinwithin thethe comment.comment. IfIf aa commentcomment hashas soso muchmuch confidentialconfidential businessbusiness informationinformation thatthat itit cannotcannot bebe effectivelyeffectively redacted,redacted, allall oror partpart ofof thatthat commentcomment maymay notnot bebe mademade publiclypublicly available.available. CommentsComments containingcontaining personalpersonal identifyingidentifying informationinformation oror confidentialconfidential businessbusiness informationinformation identifiedidentified asas directeddirected aboveabove wiiiwill bebe mademade publiclypublicly availableavailable inin redactedredacted form.form. AnAn electronicelectronic copycopy ofof thisthis documentdocument isis availableavailable atat http://www.regulations.govhttp://www.regulations.gav forfor easyeasy reference.reference. IfIf youyou wishwish toto personallypersonally inspectinspect thethe commentscomments and materialsmaterials receivedreceived or thethe supportingsupporting documentationdocumentation thethe DEADEA usedused inin preparingpreparing thethe proposedproposed action,action, thesethese materials will be available forfor publicpublic inspectioninspection by appointment. To arrange a viewing, please see thethe "For Further Information Contact" paragraph above. L LegalLegal AuthorityAuthority . Section 306 of thethe Controlled Substances Act (CS(CSA),A), 2211 U.S.C. 826, requiresrequires thethe Attorney General toto determine thethe totaltotal quantity and establish aggregate production quotas for each basic class of controlled substance listed in schedules I and II and for the list I chemicals ephedrine, pseudoephedrine, and phenylpropanolamine. This responsibility has been delegated to the Administrator of the DEA pursuant to 28 CFR 0.0.100(6).100(b). The Administrator, in turn, has redelegated that authority to the Deputy Administrator, pursuant to 28 CFR pt. 0 subpt. R, App. The DEA published the established aggregate production quotas for schedule I and II controlled substances and established assessment of annual needs for the list I chemicals ephedrine, pseudoephedrine, and phenylpropanolamine for 2015 in the Federal Register LL (79(79 FR 53216) on September 8, 2014. That notice stipulated that, in accordance with 21 3 Vol. I Page 912 L CFR 1303.131303.13 and 1315.13,1315.13, all aggregate production quotas and assessments of annual need are subject to adjustment. Analysis for Proposed Adjusted 2015 Aggregate Production Quotas and Assessment of Annual Needs The DEA proposes to adjust the established 2015 aggregate production quotas for certain schedule I and II controlled substances to be manufactured in the United States in 2015 to provide for the estimated medical, scientific, research, and industrial needs of the United States, for lawful export requirements, and for the establishment and maintenance of reserve stocks. These quotas do not include imports of controlled substances for use in industrial processes. The DEA also proposes to adjust the established 2015 assessment of annual needs for the list I chemicals ephedrine, pseudoephedrine, and c phenylpropanolamine to be manufactured in and imported to the United States in 2015 to provide for the estimated medical, scientific, research, and industrial needs of the United States, lawful export requirements, and the establishment and maintenance of reserve stocks. In proposing the adjustment, the DEA has taken into account the criteria that the DEA is required to consider in accordance with 21 CFR 1303.131303.13 and 21 CFR 1315.13.1315.13. The DEA determines whether to propose an adjustment of the aggregate production quotas for basic classes of schedule I and II controlled substances and assessment of annual needs for ephedrine, pseudoephedrine, and phenylpropanolamine by considering: (I)(1) changes in the demand for that class or chemical, changes in the national rate of net diSposaldisposal of the class or chemical, and changes in the rate of net disposal of the class or chemical by registrants holding individual manufacturing quotas for the class; (2) whether any 4 Vol. I Page 913 LL increasedincreased demanddemand forfor thatthat classclass oror chemical,chemical, thethe nationalnational and/or, and/or individualindividual ratesrates ofof netnet disposaldisposal ofof thatthat classclass oror chemicalchemical areare temporary,temporary, shortshort term,term, oror longlong term;term; (3)(3) whetherwhether anyany increasedincreased demanddemand forfor thatthat classclass oror chemicalchemical cancan bebe metmet throughthrough existingexisting inventories,inventories, increasedincreased individualindividual manufacturingmanufacturing quotas,quotas, oror increasedincreased importation,importation, withoutwithout increasingincreasing thethe aggregateaggregate productionproduction quota;quota; (4)(4) whetherwhether anyany decreaseddecreased demanddemand forfor thatthat classclass oror chemicalchemical willwill resultresult inin excessiveexcessive inventoryinventory accumulationaccumulation byby allall personspersons registeredregistered toto handlehandle thatthat classclass oror chemical;chemical; andand (5)(5) otherother factorsfactors affectingaffecting medical,medical, scientific,scientific, research,research, andand industrialindustrial needsneeds inin thethe UnitedUnited StatesStates andand lawfullawful exportexport requirements,requirements, asas thethe DeputyDeputy AdministratorAdministrator findsfinds relevant.relevant. TheThe DEADEA alsoalso consideredconsidered updatedupdated informationinformation obtainedobtained fromfrom 201420 14 year-endyear-end inventories,inventories, 201420 1 4 dispositiondisposition datadata submittedsubmitted byby quotaquota applicants,applicants, estimatesestimates ofof thethe medicalmedical c needsneeds ofof thethe UnitedUnited States,States, productproduct development,development, andand otherother informationinformation mademade availableavailable toto thethe DEADEA afterafter thethe initialinitial aggregateaggregate productionproduction quotasquotas andand assessmentassessment ofof annualannual needsneeds hadhad beenbeen established.established. OtherOther factorsfactors thethe DEADEA consideredconsidered inin calculatingcalculating thethe aggregateaggregate productionproduction quotas,quotas, butbut notnot thethe assessmentassessment ofof annualannual needs,needs, includeinclude productproduct developmentdevelopment requirementsrequirements ofof bothboth bulkbulk andand finishedfinished dosagedosage formform manufacturers,manufacturers, andand otherother pertinentpertinent information.information. InIn determiningdetermining thethe proposedproposed adjustedadjusted 20152015 assessmentassessment ofof annualannual needs,needs, thethe DEADEA usedused thethe calculationcalculation methodologymethodology previouslypreviously describeddescribed inin thethe 201020 1 0 andand 201120 1 1 establishedestablished assessmentassessment ofof annualannual needsneeds (74(74 FRFR 60294,60294, Nov.Nov. 20,20, 2009,2009, andand 7575 FRFR 79407,79407, Dec.Dec. 20,20, 2010,2010, respectively).respectively). AsAs describeddescribed inin thethe previouslypreviously publishedpublished noticenotice establishingestablishing thethe 20152015 aggregateaggregate production quotas andand assessmentassessment of annualannual needs, thethe DEADEA hashas specificallyspecifically considered thatthat inventoryinventory allowancesallowances grantedgranted toto individualindividual manufacturersmanufacturers maymay notnot alwaysalways resultresult inin 55 Vol. I Page 914914 L the availability of sufficient quantities to maintain an adequate reserve stock pursuant to 21 U.S.C. 826(a), as intended. See 21 CFR 1303.24.1303.24. This would be concerning if a natural disaster or other unforeseen event resulted in substantial disruption to the amount of controlled substances available to provide for legitimate public need. As such, the DEA has included in all proposed adjusted schedule II controlled substance aggregate production quotas, and certain proposed adjusted schedule I controlled substancesubstance- aggregate production quotas, an additional 25% of the estimated medical, scientific, and research needs as part of the amount necessary to ensure the establishment and maintenance of reserve stocks. The resulting adjusted established aggregate production quotas will reflect these included amounts. This action will not affect the ability of manufacturers to maintain inventory allowances as specified by regulation. The DEA c expects that maintaining this reserve in certain established aggregate production quotas will mitigate adverse public effects if an unforeseen event resulted in substantial disruption to the amount of controlled substances available to provide for legitimate public need, asas. determined by the DEA. The DEA does not anticipate utilizing the reserve in the absence of these circumstances. TheTHe Deputy Administrator, therefore, proposes to adjust the 2015 aggregate production quotas for certain schedule I and II controlled substances and assessment of annual needs for the list I chemicals ephedrine, pseudoephedrine,pseudocphedrine, andand. phenylpropanolamine, expressed in grams of anhydrous acid or base, as follows: c 6 Vol. I Page 915 Proposed Established LL Adjusted 2015 Basic Class 2015 Quotas Quotas • (g) M(g) Schedule II (1-Penty1-1H-indo1-3-y1)(2,2,3,3-( 1-Pentyl- l^f-indol-3 -yl)(2,2,3,3- 15 25 tetramethylcyclopropyl)methanonete;ramethylcyclopropyl)methanone (IJR-144)(UR- 1 44) H-(5-Fluoro-penty1)-111-indol-3-y11(2,2,3,3-[l-(5-Fluoro-pentyl)-l//-indol-3-yl3(2,2,3,3- 15 25 tetramethylcyclopropyl)methanonetetramethylcyclopropyQmethanone (XLR(XLR I1 I)1 ) [1{5-fluoropenty1)-[l-(5-fluoropentyl)-l//-indazol-3-yl}(naphthalen-I- I H-indazol-3-yl](naphthalen-1- 15IS no change yl)methanoneyQmethanone (THJ-2201)(THJ-220 1 ) 1-(1,3-Benzodioxo1-5-y1)-2-(methylamino)hutan-l-one1 -{l,3-Benzodioxol-5-yl)-2-(me(hylamino)butan-l -one 15 25 (butylone)(butylone) I-(1,3-Benzodioxol-5-yl)-2-(methylamino)pentan-t-onel-(l,3-Benzodioxol-5-yl)-2-(methylamino)pentan-l-one IS15 25 (pentylone)(pentylone) 1-(1-Phenyleyclohexyl)pyrrolidine1 -(1 -Phenylcyclohexyl)pyrrolidine 10 no change 1-(5-Fluoropenty1)-3-(1-naphthoyeindole1 -(5-Fluoropentyl)-3-( 1 -naphthoyl)indole (AM2201)(AM220 1 ) 45 no change 1-(5-Fluoropenty1)-3(2-iodobenzoypindolel-(5-F!uoropentyl)-3-(2-iodobenzoyI)indole (AM694)(AM694) 45 no change 141-(2-ThienypcyclohexylipiperidineI-[l-(2-Thienyl)cyclohexyl]piperidine 15 no change 142-(4-Morpholinypethy1]-3-(I-naphthoyflindolel-[2-(4-Morpholinyl)ethyl]-3-(l-naphthoyl)indole (MB(JWH-- 45 no change 200) 1l-Butyl-3-(l-Butyl-3-(1-naphthoyl)indole (JWH-073)(JWH-073) 45 no change L 1-Cyclohexylethy1-3-(2-methoxyphenylacetypindole] -CyclohexylethyI-3-(2-methoxyphenylacetyl)indole (SR(SR-- 45 no change 18 and RCSRCS-8)-8) 1-11exy1-3-(1-naphthoyl)indole1 -Hexyl-3-( 1 -naphthoyl)indole (JWH-019)(JWH-0 19) 45 no change 1-Methyl-4-phenyl-4-propionoxypiperidinel-Methyl-4-phenyI-4-propionoxypiperidine 2 no change 1-Penty1-3-(1-naphthoypindolel-Pentyl-3-(l-naphthoyI)indole (INVH-0(JWH-018 18 and AM678) 45 no change 1-Penty1-3-(2-chlorophenylacetyl)indolel-Pentyl-3-(2-chlorophenylacetyl)indole (JWH-203)(JWH-203) 45 no change 1-Penty1-3-(2-methoxyPhenylacetyl)indolel-Pentyl-3-(2-methoxyphenylacetyl)indole (1WH-250)(JWH-250) 45 no change 1-Penty1-3-(4-chloro-1 -Pentyl-3-(4-chloro- 1 -naphthoyl)indole -naphthoy[)indo!e (1W11-398)(JWH-398) 45 no change 1-Pentyl-l-Pentyl-3-(4-methyl-l-naphthoyl)indole.3-(4-methyl- 1 -naphthoyBindole (IWEI-122)(JWH-122) 45 no change 1-Pcnty1-3[(4-methoxy)-benzoyl]indolel-Pcntyl-3-[(4-methoxy)-benzoyI]indole (SR(SR-19,-19, RCSRCS-4)-4) 45 no change 1-Penty1-311-(4-methoxynaphthoyl)]indolel-Pentyl-3-[l-(4-methoxynaphthoyl)]indole (1(JWH-081)WH-081) 45 no change 2-(2,5-Dimethoxy-4-n-propylphenyl)ethanamine2-(2,5-Dimethoxy-4-«-propylphenyl)ethanamine (2C(2C-P)-P) 30 no change 2-(2,5-Dimethoxy-4-ethylphenypethanamine2-(2,5-Dimethoxy-4-ethylphenyl)ethanamine (2C(2C-E)-E) 30 no change 2-(2,5-Dimethoxy-4-methylphenyBethanamine2-(2,5-Dimethoxy-4-methy[pheny])ethanamine (2C(2C-D)-D) 30 no change 2-(2,5-Dimethoxy-4-nitro-phenyl)ethanamine2-(2,5-Dimethoxy-4-nitro-phenyI)ethanamine (2C(2C-N)-N) 30 no change 2-(2,5-Dimethoxyphenyl)ethanamine (2C(2C-H)-H) 30 no change 2-(4-Bromo-2,5-dimethoxyphenyI)-N-(2-2-(4-Bromo-2,5-dimethoxyphenyl)-N-(2- 15 25 L methoxybenzyl)ethanamine (258-NBOMe;(25B-NBOMc; 2C-B-NBOMe;2C-B-NBQMe; 7 Vol. I PagePage 916 LL 25B; Cimbi-36) 2-(4-Chloro-2,5-dimethoxyphenyl)ethanamine (2C(2C-C)-C) 30 no change 2-(4-Chloro-2,5-dimethoxypheny1)-N-(2-2-(4-Chloro-2,5-dimethoxyphenyl)-A''-(2- methoxybenzyl)ethanamine (25C-NBOMe;(25C-NBOMe; 2C-C-NBOMe; 15 25 25C; Cimbi-82) 2-(4-ledo-2,5-dimethoxyphenyDethanamine2-(4-Iodo-2,5-dimethoxyphenyl)ethanamine (2C-1)(2C-I) 30 no change 2-(4-Iodo-2,5-dimethoxypheny1)-N-(2-2-(4-Iodo-2,5-dimethoxyphenyl)-Af-(2- methoxybenzyl)ethanamincmethoxybenzyl)ethanamine (251-NBOMe;(251-NBOMe; 2C2C-I--I- 15 • no change NBOMe; 251;25I;Cimbi-5) Cimbi-5) 2-(Methylamino)-1-phenylpentan-12-(Methylamino)-I-phenylpentan-l-one-one (pentedrone)(pentedrone) 15 no change 2,5-Dimethoxy-4-ethylamphctamine2,5:Dimethoxy-4-ethylamphctamine (DOET)(DOET) 25 no change 2,5-Dimethoxy-4-n-propyithiophenethylamine2,5-Dimethoxy-4-n-propylthiophenethylamine 25 no change 2,5-Dimethoxyamphetamine 25 no change 2[4-(Ethylthio)-2,5-dimethoxyphenyliethanamine2-[4-(Ethylthio)-2,5-dimethoxyphenyl)ethanamine (2C(2C-T--T- 30 no change 2)21 2[4-(lsopropylthio)-2,5-dimethoxyphenyllethanamine2-[4-(lsopropylthio)-2,5-dimethoxyphenyl]ethanamine 30 no change (2C(2C-T-4)-T-4) 3,4,5-Trimethoxyamphetamine 25 no change 3,4-Methylenedioxyamphetamine3,4-Methylencdioxyamphetamine (MDA)(MDA) 55 no change 3,4-Methylenedioxymethamphetamine3 ,4-Methylenedioxymethamphetamine (MDMA)(MDMA) 50 no change Lc 3,4-Mohylenedioxy-N-ethylamphetamine3,4-Mcthylenedioxy-fV-ethylamphetamine (MDEA)(MDEA) 40 no change 3,4-Methylenedioxy-N-methylcathinone3,4-Methylenedioxy-iV-methylcathinone (methylone)(methylone) 50 no change 3,4-Methylenedioxypyrovalerone (MDPV)(MDPV) 35 no change 3-Fluoro-N-methylcathinone3-Fluoro- 4-Methoxyamphetamine 100 no change 4-Methyl-2,5-dimethoxyamphetamine4-Methyl-2,5-dimethoxyamphelaminc (DOM)(DOM) 25 no change 4-Methylaminorex 25 no change 4-Methyl-N-ethylcathinone4-Methyl-jV-ethylcathinone (4-MEC)(4-MEC) 15 25 4-Methyl-N-methylcathinone4-Methyl-iY-methylcathinone (mephedrone)(mephedrone) 45 no change 4-Methyl-a-pyrrolidinopropiophenone (4-MePPP)(4-MePPP) 15 25 5-(1,1-Dimethylhepty1)-2-1(1R,38)-3-hydroxycyclohexyli-5-(l,l-Dimethylheptyl)-2-[(l/?,35)-3-hydroxycyclohexyl]- 68 no change phenol L 5-(1,1-Dimethylocty1)-21(1R,3S)-3-hydroxycyclohexylk5-(l , 1 -Dimethyloctyl)-2-[( 1 /?,35)-3-hydroxycyclohexyl]- 53 no change 8 Vol. I PagePage 917 L phenol (cannabicyclohexanol or CP-47,497,C8-homolog)CP-47,497.C8-homolog) 5-Methoxy-3,4-methylenedioxyamphetamine5-Methoxy-3,4-methyienedioxyamphetamine 25 no change 5-Methoxy-N,N-diisopropyltryptamine5-Methoxy-/W-diisopropyltryptamine 25 no change 5-Methoxy-N,N-dimethyltryptamine5-Methoxy-N,jV-dimethyltryptamine 25 151511 change Acetyl-alpha-methylfentanylAcetyl-a/p/io-methylfentanyl 2 no change Acetyldihydrocodeine 2 no change Acetylmethadol 2 no change Allylprodine 2 no change Alphacetylmethadol 2 no change alpha-Ethyltryptaminea/p/jn-Ethyltryptamine 25 no change Alphameprodine 2 no change Alphamethadol 2 no change alpha-Methylfentanyla/pAcr-Methylfentanyl 2 no change alpha-Methylthiofentanyln/pAo-Methyltfriofentanyl 2 no change alpha-Methyltryptamineo/p/w-Methyltryptamine (AMT) 25 no change alpha-Pyrrolidinobutiophenoneo/pAa-Pyrrolidinobutiophenone (a-PBP)(a-PBP) 15 25 alpha-Pyrrolidinopentiophenoneo/pte-Pyrrolidinopentiophenone (a-PVP)(o-PVP) 15 25 c Aminorex 25 no change Benzylmorphine 2 no change Betacetylmethadol 2 no change beta-Hydroxy-3-methylfentanyli^ta-Hydroxy-3-methylfentanyl 2 no change beta-Hydroxyfentanylheta-Hydroxyfentanyl 2 no change Betameprodine 2 no change Betamethadol 4 no change Betaprodine 2 no change Bufotenine 3 no change Cathinone 70 no change Codeine methylbromide 5 no change CodeineCodeine-/V-oxide-N-oxide 305 no change Desomorphine 5 25 Diethyltryptamine 25 no change Difenoxin 11,000 no change Dihydromorphine 3,990,000 no change DimethyltryptamineDimethyltryptamine 35 no change no change c DipipanoneDipipanone 5 9 Vol. I PagePage 918 LL Fenethyllinc 5 no change gamma-Hydroxyhutyricga/wna-Hydroxybutyric acid 70,250,000 no change Heroin 25 50 Hydromorphinol 2 no change Hydroxypethidine 2 no change IbogaineIbogaine 5 no change Lysergic acid diethylamide (LSD)(LSD) 35 no change Marihuana 658,000 no change Mescaline 25 no change Methaqualone 10 no change Methcathinone 25 no change Methyldesorphine 5 no change Methyldihydromorphine 2 no change Morphine methylbromide 5 no change Morphine methylsulfonate 5 no change MorphineMorphine-A'-oxide-N-oxide 350 no change N-(1-Adamanty1)-1-penty1-1H-indazole-3-carboxamideN-( 1 -Adamantyl)- 1 -pentyl- 1 W-indazole-3-carboxamide 15 25 (AKB4S)(AKB48) N-(1-Amino-3,3-dimethyl-l-oxobutan-2-y1)-1-penty1-1H-A^l-AminoO^-dimethyl-l-oxobutan^-y^-l-pentyl-l//1 L 15 25 indazole-3-carboxamideindazole-3-carboxamide (ADB-PINACA)(ADB-PINACA) N-(1-Amino-3-methy1-1-oxobutan-2-y1)-1-(4-7V-(l-Amino-3-methyl-l-oxobutan-2-yl)-l-(4- fluorobenzyl)-1H-indazole-3-carboxamidefluorobenzyl)-l//-indazole-3-carboxamide (AB-(AB- 15 25 FUBINACA) N-(1-Amino-3-methy1-1-oxobutan-2-y1)-1-N-( 1 -Amino-3 -methyl- 1 -oxobutan-2-yl)- 1 - (cyclohexylmethyl)-1Thindazole-3-carboxamide(cyclohexylmethyl)-l//-indazole-3-carboxamide (AB-(AB- 15 no change CHMINACA) N-(1-Amino-3-methyl-l-oxobutan-2-y1)-1-penty1-1N-( 1 -Amino-3 -methyl- 1 -oxobutan-2-yl)-l -pentyl-1H- 15 no change indazole-3-carboxamideindazole-3-carboxamide (AB-PINACA)(AB-PINACA) N,N-DimethylamphetamincAyV-Dimethylamphetaminc 25 no change Naphthylpyrovalerone (naphyrone)(naphyrone) 15 25 N-Benzylpiperazine 25 no change N-Elhyl-I-phenyleyclohcxylamineN-Ethyl- 1 -phenylcyclohcxylamine 5 no change N-EthylamphetaminejV-Ethylamphetamine 24 no change N-Hydroxy-3A-methylenedioxyamphetamineAf-Hydroxy-3,4-methylenedioxyamphetamine 24 no change Noracymethadol 2 no change Norlevorphanol 52 no change ^ Normethadone 2 no change NonnorphineNormorphine 18 40 1010 Vol. I PagePage 919 L Para-fluorofentanyl .. zero 5 Parahexyl zero 5 Phenomorphan 2 no change Pholcodine zero 5 Psilocybin 30 no change Psilocyn 30 no change Quinolin-8-y1Quinolin-8-yl 1-(5-fluoropcnty0-1H-indole-3-carboxylate|-(5-fluoropcntyl)-l//-indole-3-carboxylate 15 25 (5-tluoro-PB-22;(S-fluoro-PB-22; 5F-PB-22) Quinolin-8-yl l-penty1-1H-indole-3-carboxylatel-pentyl- l//-indole-3-carboxylate (PR(PB-22;-22; 15 25 QUPIC) : ' Tetrahydrocannabinols 497,500 511,250 Thiofentanyl 2 no change Tilidine 10 25 Trimeperidine 2 no change Schedule IIII 1-Phenyleyclohexylaminel-Phenylcyclohexylamine 5 no change 1-Piperidinocyclohexanecarbonitrile1-Piperidinocyclohexanccarbonitrile 5 no change 4-Anilino-N-phenethy1-4-piperidine4-Anilino-vV-phenethyl-4-piperidine (ANPP)(ANPP) 2,687,500 no change Alfentanil 17,750 no change ' Alphaprodine 3 no change Amobarbital 25,125 no change Amphetamine (for(for conversion) .• 21,875,000 no change Amphetamine (for(for sale) . .. 37,500,000 no change Carfentanil 19 no change Cocaine 275,000 no change Codeine (for(for conversion) 50,000,000 no change Codeine (for(for sale) .. 49,500,000 63,900,000 Dextropropoxyphene 19 45 Dihydrocodeine 226,375 .• no change Diphenoxylate (for(for conversion) 75,000 no change Diphenoxylate (for(for sale) 1,337,500 no change Ecgonine 174,375 no change Ethylmorphine 3 no change Fentanyl 2,150,000 2,300,000 Glutethimide 3 no change L Hydrocodone (for(for conversion) 137,500 no change 11 Vol. I PagePage 920 L Hydrocodone (for sale) 99,625,000 no change Hydromorphone 7,000,000 no change Isomethadone 5 no change Levo-alphacetylmethadol (LAAM) .44 no change Levomethorphan 5 30 Levorphanol 7,125 no change Lisdexamfetamine 29,750,000 no change Meperidine 6,250,000 no change Meperidine IntermediateIntermediate-A-A 6 no change Meperidine IntermediateIntermediate-B-B 11II 32 Meperidine IntermediateIntermediate-C-C 6 no change Metazocine 1919 no change Methadone (for sale) 31,875,000 no change Methadone Intermediate 34,375,000 no change Methamphetamine 2,061,375 no change [1,250,000[1,250,000 grams of /evo-desoxyephedrine for use in a nonnon-controlled,-controlled, non-prescription product; 750,000 grams for methamphetamine mostly for conversion too a schedule III product; and 61,375 grams for methamphetamine (for sale)] Methylphenidate 83,750,000 87,500,000 Morphine (for conversion) 91,250,000 no change Morphine (for sale) 62,500,000 no change Nabilone 18,75018,750 no change Noroxymorphone (for conversion) • 17,500,00017,500,000 no change Noroxymorphone (for sale) 1,475,0001,475,000 no change Opium (powder) 112,500112,500 no change Opium (tincture) 687,500 no change Oripavine 35,000,000 no change Oxycodone (for conversion) 8,350,000 no change Oxycodone (for sale) 137,500,000137,500,000 139,150,000139,150,000 Oxymorphone (for conversion) 29,000,000 no change Oxymorphone (for sale) 7,750,000 no change Pentobarbital 35,000,000 no change no change J Phenazocine 6 no change Phencyclidine 1919 38 PhenmetrazinePhenmefrazine 3 no change Phenylacetone 9,375,000 no change 1212 Vol. I Page 921 LL Racemethorphan 3 no change RemifentanilRcmifentanil 3,750 4,200 SccobarbitalSecobarbital 215,003 no change •' SuferaanilSufentanil .6,2556,255 no change Tapentadol 12,500,00012,500,000 no change Thebaine 125,000,000125,000,000 no change List I Chemicals Ephedrine (for conversion) 1,000,0001,000,000 no change Ephedrine (for sale) 4,000,000 no change PhcnylpropanolaminePhenylpropanolamine (for conversion) 44,800,000 no change Phenylpropanolamine (for sale) 8,500,000 no change Pseudoephedrine (for conversion) 7,000 no change Pseudoephedrine (for sale) 224,500,000 no change The Deputy Administrator further proposes that aggregate production quotas for all other schedule I and II controlled substances included in 21 CFR 1308.11308.1 l1 and 1308.121308.12 LL remain at zero. Pursuant to 21 CFR 1303.131303.13 and 21 CFR 1315.13,1315.13, upon consideration of the relevant factors, the Deputy Administrator may adjust the 2015201 5 aggregate production quotas and assessment of annual needs as needed. Comments Pursuant to 21 CFR 1303.11(c)1303.11(c) and I315.11(d),1315.1 1(d), any interested person may submit written comments on or objections to these proposed determinations. Based on comments received in response to this notice, the Deputy Administrator may hold a public hearing on one or more issues raised. 21 CFR 1303.11(c)1303.11(c) and 1515.11(e).1515.11(e). In the event the Deputy Administrator decides to hold such a hearing, the Deputy Administrator will publish a notice of the hearing in the Federal Register. After consideration of any comments or objections, or after a hearing, if one is held, theJhe Deputy Administrator will issue and publish in the Federal Register a final order establishing any adjustment of L 1313 Vol. I Page 922 LL 201520 1 5 aggregate production quota for each basic class of controlled substance and established assessment of annual needs for the list I1 chemicals ephedrine, pseudoephedrine, and phenylpropanolamine. 21 CFR 1303.11(c)1303.ll(c)and and 1315.11(f).1315.11(f). Dated: John S.J. Riley, Acting Deputy AdministratorAdministrator. Lc LL 1414 Vol. I Page 923 LL OC: OD:OD: OD/D:OD/D: ODX:ODX: ODXS:ODXS: ODW:ODW: ODWAnalysi:ODWAnalyst:. ODQ:ODQ: ODQ:ODQ:•Kb)(6) b)(6) (date)date) SBF-CMSBF-CM# # ODEQODEQ S:\ODQ\FederalS:\ODQ\Federal Register\Register\ LL L 1515 Vol. I Page 924 C*9. 39156 Federal Register/Register/Vol. Vol. BO,BO,. No. 130 /Wednesday, July 8, 20152015/Notlces /Notices Dated: July 1.2015.1. 2015. submitted and there isis no need to An electronic copy of this document RobedRobert W. Middleton, resubmitresubmit the same comment. Paper isis available at http:// L unenv.regulations.govwww.regulalians.gov for easy reference.reference. Deputy Chief, Office ofOffshereofOffshore Regulatory comments that duplicate electronic necessary and are Programs. submissions are not necessary and are Legal Authority and Background IFS|FR Doe.Doc. 2015-180752015—16675 Filed 7-7-15:8:45 allami discouraged. Should you wish to mail a paper comment inIn lieulieu of an electronic Section 306 of the Controlled BILLINGSILLING CODE 41110-Vil-le4310-VH-P paper comment.comment, itit should be sent via regularregular Substances Act (CSA),(CSA), 21 U.S.C. 826, or express mail to: Drug Enforcement requiresrequires the Attorney General to Administration, Attention: DEA Federal determine the total quantity and DEPARTMENT OF JUSTICE establish aggregate production quotas Register Representative/ODL, 8701 establish for each basic class of controlled - Drugrug Enforcement Administration Morrissette Drive,Drive. Springfield.Springfield, Virginia substance listedlisted inin schedules landI and IIII 22152. [Docket[Docket No. DEA-418P)DEA-418P] and for the listlist II chemicals ephedrine. FOR FURTHER INFORMATIONINFORMATION CONTACT: John pseudoephedrine, and to the Proposed Adjustments to the R. Scherbenske.Scherbensko. Office of Diversion phenylpropanolamine. This Aggregate Production Quotas for Control, Drug Enforcement responsibilityresponsibility has been delegated to the Schedule II and IIII Controlled Administration, 8701 MorrisselteMorrissette Drive, Administrator of the DEA. 28 CFR Substances and Assessment of Springfield, VirginiaViiginia 22152, Telephone: 0.100(b). Annual Needs for(or the List II Chemicals (202)(202) 598-6812.596-6812. The DEA established the 2015 Ephedrine, Pseudoephedrine, and aggregate production quotas for PhenylpropanolamlnePhenylpropanolamine for 2015201 5 SUPPLEMENTARY INFORMATION:INFORMATION: substances inin schedules II and II11 and the assessment ofofannual annual needs for the listlist AGENCY: Drug Enforcement Posting of Public Comments II chemicals ephedrine. Administration.Administration, Department of Justice. Please note that allail comments pseudoephedrine, and ACTION: Notice with requestrequest for receivedreceived inin responseresponse to this docket arearc phenylpropanolamine on September 8,6, comments. considered part of the public recordrecord and 2014 (79(79 FR 53216). That notice accordance with 21 SUMMARY: The Drug Enforcement will be made available for'publicfor public stipulated that, inin accordance with 21 CFR 1303.13 and 1315.13, all aggregate Administration proposes to adjust the inspectioninspection online at blip://http:// production quotas endand assessments of 2015 aggregate production quotas for www.regulations.gov. Such informationinformation annual need are subject to adjustment. several controlled substances inin includesincludes personal identifyingidentifying schedules II and IIII of the Controlled informationinformation (such(such as your name, Analysis for Proposed Adjusted 2015 Substances Act and the assessment of address.address, etc.)otc.) voluntarily submitted by Aggregate Production Quotas and annual needsnoods for the listlist II chemicals the commenter.commenter, Assessment of Annual Needs pseudoephedrine, and ephedrine,ephedrine. pseudoephedrine, and The Freedom of InformationInformation Act The DEA proposes to adjust the phenylpropanolamine. c (FOIA)(FOIA) applies to all comments established 2015 aggregate production personal OATES: InterestedInterested persons may fifilele - received.received. IfIf you want to submit personal quotas for certain schedule II and IIII written comments on this notice inin identifyingidentifying informationinformation (such(such as your controlled substances to be accordance with 21 CFR 1303.13(c) and name, address.address, etc.) as part of your manufactured inin the United SlatesStates inin 1315.13(4).1315.13(d). Electronic comments must comment, but do not want itit to be 2015 to provide for the estimated be submitted, and written comments posted online or made available inin the medical, scientific, research,research, and must be postmarked, on or before public docket, you must includeinclude the Industrialindustrial needs of the United States, August 7.7, 2015. Commenters should be phrase "PERSONAL IDENTIFYINGIDENTIFYING lawfullawful export requirements,requirements, and the aware that the electronic Federal Docket INFORMATION"INFORMATION" inin the first paragraph establishment and maintenance of Management System will not accept • of your comment. You must also place reservereserve stocks. These quotas do not comments after 11:59 p.m. Eastern Time all the personal identifyingidentifying informationinformation includeinclude importsimports of controlled on the lastlast day of the comment period. you do not want made publicly substances for use inin Industrialindustrial the first paragraph of your AmmEsses:aodresses; To ensure proper handling available inin the first paragraph of your processes. ThoThe DEA isis not proposing to comment and identifyidentify what informationinformation of comments, please referencereference "Docket adjust the established 2015 assessment you want redacted.redacted. No. DEA-418P" on all correspondence.correspondence, of annual needs for the listlist II chemicals includingincluding any attachments. The Drug IfIf you_ want to submit confidential ephedrine, pseudoephedrine, and Enforcement Administration encourages business informationinformation as part of your phenylpropanolamine to be that all comments be submitted comment, but do not want itit to be made manufactured inin and importedimported intointo the electronically through the Federal publicly available, you must includeinclude the United States inin 2015 to provide for the eRulemaking Portal which provides the phrase "CONFIDENTIAL BUSINESS estimated medical.medical, scientific, research,research, ability to type short comments directly INFORMATION"INFORMATION" inin the first paragraph and industrialindustrial needs of the United intointo the comment field on the Web page of your comment. You must also States, lawfullawful export requirements,requirements, and or attach a file for lengthierlengthier comments. prominently identifyidentify the confidential the establishment and maintenance of Please go to hitp://www.regulations.govhttp://www.regulations.gov business InformationInformation to be redactedredacted reservereserve stocks. and follow the online instructionsinstructions at within the comment. IfIf a comment has InIn proposing the adjustment, the DEA that site for submitting comments. Upon so much confidential business has taken intointo account the criteria that completion of your submission you will informationinformation that itit cannot be effectively the DEA isis requiredrequired to consider inin receivereceive a Comment Tracking Number for redacted,redacted, all or part of that comment accordance with 21 CFR 1303.13 and 21 your comment. Please be aware that may not hebe made available inin the public CFR 1315.13. The DEA determines submitted comments are not docket. Comments containing personal whether to propose an adjustment of the instantaneouslyinstantaneously available for public identifyingidentifying informationinformation or confidential aggregate production quotas for basic view on Regulations.gov.Regulatians.gov. IfIf you have business informationinformation identifiedidentified as classes of schedule II and IIII controlled L received' d a CComment mm ntTTracking g NNumber, mb directed above will be made publicly substances and assessment of annual your comment has been successfully available inin redactedredacted form. needs for ephedrine. pseudoephedrine, Vol. I PagePage 925 •a 3 1 1 s S " £ . Federal8 Register/Vol. 80, No. 130/Wednesday, My 8, 2015 /Notices 391157 J "S Ill J3 sisllflllJll!Ssiil!1lpsl!i!!l! -§^S-S|2|g5w-^«S2s|g8|.SS4^2"s!e3g3-2^-= =2l I IllllPiIlllilllf !isjgrsl-|i3|aiii°si4igi"gsi||5^£ii| 3bbS |||f|-2l||^i£pr||'|g|-|||ps'ss-g2j|| 2 ^-3-s"il.«i4lsls8i.i23!s,ySo2 fl o",»«Ot!,o03S3'SaNM>o-nclSeSB and FS** siF-ii «UM O b.,3 © considering (11 Changes in the demandg the DEA after the initial aggregate included in all proposed adjusted ^_c~32«c5 £orT}5is<»>«-'®E§cS2 .5 « o M 8 changes in the production quotas and assessment of schedule II controlled substance for that class or chemical, ljjlf-3"! §3« "o t5 Hill 2---3-2I o"ooa!sJ®«SE-E a-? ^SSlSi'l'&ss-08 mitigate adverse public So"2£3"".-^S'"EE2 5®" « „ quotas will ,5 *•* aggregate production quotas and §l|l^|o § 1111311 - "> chemical will result in excessive g I M li^-8 e « £ effects if an unforeseen event results in — s o C «0-S-k-»v>i2 inventory accumulation by all persons assessment of annual needs, the DEA S "d lis" "Ill S registered to handle that class or has specifically considered that 8 ® " If, 1 S Q " « controlled substances available to Ma-s g « chemical; and (5) other factors affecting inventory allowances granted to a-S M a J.-slI "---5S ^ provide for legitimate public need, as u ,| individual manufacturers, 21 CFR o 3 medical, scientific, research, and -c |-i"l I 2 W sl sli-J determined by the DEA. The DEA does .y c'-O £ 1303.24, may not always result in the e<5 = needs in the United States £3!'>o0»u2 industrial 2 - 3 83 l-H ifli « not anticipate utilizing the reserve in | and lawful export requirements, as the availability of sufficient quantities to - ^ £ ^j-a || the absence of these circumstances. adequate reserve stock £8^1! maintain an Acting Administratorft| finds relevant. S™ls3 — < g)-s O u 153! The DEA also° considered= updated pursuant to 21 U.S.C. 626(a). as The Acting Administrator, therefore, |s|l £3j« "I s| 2 § >»d §•3 . 1 proposes to adjust the 2015 aggregate information obtained from 2014 year- intended. This would be concerning if .2 "C N- 2 &=§ 11 1||^ M s U production quotas for certain schedule I end inventories, 2014 disposition data a natural disaster ar other unforeseen 13 |-sf Ii « 3 £ 2 J submitted by quota applicants, event resulted in substantial disruption and II controlled substances expressed Si „ b i i! estimates of the" a> E medical needs of the to the amount of controlled substances in grams of anhydrous acid or base, as J 1 United States,VI * a. product2 development, available to provide for legitimate follows: T3 fig go %% *& ii° ,m Proposed|ii * Established s O 2015 Quotas Adjusted 2015 Basle« class Quotas 2 > (9) (g) * Schedule1 T> "3 ; I 2.14 ioioiniA)AO|oifluiu)U)mu)(v^ioiA^(n|n^ogooom OlOJCCYOJCecCCCCCCCCCCCCCCCCCGOJ mmoinmoocooooocoooooooooooou^ 5 2 slim It! tl Iflli {}!f| "* ¥ ££ lit I1III (1-Peniy1-1H-Indol-3.y1)(2,2,3,3-tetramelhylcycloondnyl)methanoneipif (LIF1-144) 15 25 5 !i||f =4 l?i (1.(5-ReorasentyfilH-indel-311)(2,2,3,3-tetramethyleyelopropyl)methananeS (XLR11) 15 25 i i- o C w. Ail [1(5-11uoropenty1).1H-Inda2o1-3113(naphthalen-lil)meinanone (THJ-2201) i 15 no change 9 I! 5Si til 1-(1,3-Benzodionol-5-y1)-2-(methylamlno)butan-1-cnelbutylona) 1 'i 15 25 «? I 1.(1,3.Benzedierol.5.y1).2.imethylamlnajpentan-l-one (pentylone) i 15 25 | firfi oooovoo'SuuSooo'Souoooo C]4IQ!(l9>d)S4)4)9Ofitl0)4IUQCfiOS) CCCCCCCCCCCCCCCCCCCCG D) lit 1-0.Phenyleyeloberyfipyrrolidine ill-tlfllHSllilllilt? ill ill M 10 no change I 1 ?II II o) 1-(5•Fluaropenyl)-3{t-naphthoygindoleri (AM2201) 45 no change ItllJ 1 o> 1-(5-Fluerepenty1)-312-10dobenzoyDindole (AM694) i 45 no change S til I!!|!f!!ltl!ttf o) l! 141-(2.Thieny)cydeharyllpipeddine i|J^II|l|liHli!! i| if 15 no change ? |f 1-[2.(4-Morpholinygethy11.3-0-naphthoygindole (.1WH-200) 45 no changen fcf 2 oi ? IS 1-Buty1-3-(1-naphlhoyl)indole (JWH-073) ii is 45 no change o I 1 Sl?|IIi|!l I nt 1-Cyclohexylethy1-342-methoxyphenylacetPlindeleg.£ (SR-le and RCS-5) 45 no change ft it II 415 o 1-11exy1.341.naphtbayginaole (MH-019) i 1 45 no change nocDoaioioioicn ac.Si&S.S.S^.f If#®#* 1-Methyl-4-phenp-4-proolonexypiperidine I 2 no change 1-Penty1-3-(1-naphlhoyl)indole1 f it (JWH-018 and AM678) 45 no change ? 1-penty1-3-(2-chloropnenytheetPlindoie1 5- (JWH- 203) 45 no change 1 5- it 1-Penty1-3.(2-methioxyphenylacety0Indolei (JW11-250) 45 no change 1 i 1-Penty1-3-(4-chloro-l-naphthoynindole2- (JW/1-398) 45 no change ! 1-Penty1-3-(4-methyltnaphtheyllindole2- s h (JVVH-122) .45 no change _ 1-Penty1-3.(14-melhoxy).0enzoyllindoleI 5 ? (SR-19, RCS-4) 45 no change ! ± 2-9 1.Penty1-3-i144-methoxynanntheyillndolei (JWH-051) 45 no change SSSSSts || gf Hi}! 2-(2,5-pirnethext4-n-prepylpheny)ethenamine (2C-P) . 30 no change 2-12,5-131methoxy-4-ethylphanybethanarnine9 1 (2C-E) 30 no changec> 9 If a 1 | 2.(2,5-Ciniethcxy-4-methylphenyl)ethanaminem??? (2C-0) ' 30 no change o> 9 1 |1| 30 no change J 212,5-Dimethoxy-4-nitro-phenynelhanamine (2C-N) o 9 1 I II 2-(2,5-Cimethoxyphenypelhanamine (2C-H) ir 30 no change CM m J> ci I ^ 01 1 2-(4-Bromo-2.5-dirnethoxypnenyll-N.(2-methoxyhenzyl)ethanamlnesV.E (25B-N130Me: 2C-B-NBOMe; 15 25 | 2513; Cimbi.36). o i I I i * o ± S i e o £ w. 2-(4-Chlero-2,5-dimethoxyphenynethanamine1 (2C-C) 30 no change 0_ Established Proposed 2015 Quotas Adjusted 2015 Quotas L Basic class (9)(9) (al(9) 1515 12525 2-(4-Chlom-2,S.dimethoxyphenyI)-Aa(22-(4-Ch1ora-2,5-dimethoxyphenyI)-iV-(2-m0thoxybenzy()ethanamine-m etho,tybenzygethanamine (25C-NBOMe;(Z5C-NBOMe; 2C-C-NBOMe;2C-C-NSOMe; 25C25C; ambi-82).Clmbi-82). . 30 no change 2-(4-lodo-2.5-MmethozyPhenyl)elhanamine2-(4-lodo-2.5-Cimethoxyphenyi)elhanamine (2C-I) 251; 1515 no change 2-(4-lodo-2,5-dlmeOoxypheny1)-N-(2-methoxybenzyl)ethanamine2-(4-iodo-2,5-dlmethoxypheny.l)-W-(2-methoxybenzy1)ethanamine (251-NBOMe;(251-NBOMe; 2C-1-I2C-l-NBOMe;,1B0Me; 251; Cimbi-5).lc 1516 nochangeno change 2-(methylamino)-Iphenylpentan-tone2-(Methylamino)-i;phenyipentan-Vone (pentedrOne)(pentedrone) 25 nochangeno change 25-Dimelhoxy.4-ethylamphelamine2,5-Dimelhoxy-4-elhylamphetamine (DOE1)(DOET) 25£5 no change 2,5.11methoxy-4-n-propylthioPhenethylamine2,5-Qimelhoxy-4-n-propyHhiophenethyfamine 25 no change 2,5-Dimethoxyamphetamine 30 no change 2-(4-(51hylthio)-2,5-dimethozyPhenygelhanamlne2-|4-(Elhylthio)-2.5-dimethoxyphenyllclhanarrine (20-T-2)(2C-T-2) 30 no change 2(4-(lsopropylthio)-2.5-dimelhoxyphenyljethanamino2-[4-(lsopropylthio)-2,6-di(Tielhoxyphenyl]ethanamino (2C(2C-T-4)-T-4) 25 no change 3,4,5-TrImethoxyamphetaniine3,4.5-TrlmeUioxyamphetafriine 5535 mcno change 3.4-Methylenedioxyamphetimine3,4-Methylenedioxyamphetamine (MOA)(MOA) 50 no change 3,4.Methylenedionmethemphelamine3.4-MelhylenedioxymeiharTphelamine (MOMA)(MOMA) 40 no change 3,4-Methylenedloxy-Na3.4-Methylenedloxy-W-ethylampheternifie (MDEA) 50 nochangeno change 3,4-Methylenedioxy-AamethylcathIncne3,4-Methylenedioxy-N.melhylcathincne (methylene)(methylene) 35 nochangeno change 3,4-Methylenedioxypyrovalcrene3,4-Methylenedioxypyrovalcrone (MDPV)(MDPV) 1515 25 3-Flucro-namethylcathinone3-Fluoro-N-methylcathinone (3(3-FMC)-FMC) 2 no change 3-Melhyllentanyl3-Methylfentanyl 2 no change 3-Malhylthlofentany13-Methyllhlofentany l 25 nochangeno change 4-Brerno-2.5-dimeLhoxyamphetamine4-Bromo*2,5-dimetho*yamph«amine (DCB)(DOB) — 25 nochangeno change 4-13romo-Z5-dimethoxyPhenethylamine4-Bromo-2.5-dimethoxyphenethylamine (2(2-CB)-GB) 15 25 4-Fluoro-Aamelhylcalhinone4-FKioro-W-meihyleaihinone (4(4-FMC)-FMC) . 100 nochangeno change 4-Melhoxyamphetamine 4-Meihoxyamphetamine 25 no change 4-Melhy1.2,5-dimelhoxyamPhetamine4-Methyl-2,5-dimelhoxyamphetamioe (Dom)(DOM) 25 nochangeno change 4-Meihylamirorex-Methyl 4 115 25 4-Methyl-N-ethylcathinone4-Methyl-W-ethylcathinore (4-MEC)(4-MEC) 445 no change 4-Methyl.AFmethylcaihinore4-Methy(-iVmelhyfcalhinone (mephedrona)(mephedrone) 115 25 4-Methyl-o-pyrrolidinoproPloPhenone4-Methyl-a-pyrrolidinoproplophenone (4-MaPPP)(4-MePPP) 668 nochangeno change 5-(1,1-Dirnothylheptsol)-24(1R,35)-35-(1,1-Dimothylheptyl)-2-[|1fl,3S)-3-hy{Jroxycyc!ohexyl]-phenol-hydroxycyclohexyl]thenol CP-47.497 553 no change 5-(1.1-6-(1,vDimethykx:tyi)-2-((lfl.3S)-3-hydfoxycyclohexyl]-Phenol-U1P,35)-3-hydroxycyclohexyll-phenol((1 (cannabicyolohexanol(cannabicyclohaxanol or CP-47,497 CB-homolog).C3-homolog). 225 no changeChange 5.Methoxy-3,4-methylenedloxyamPhetamineS-Methoxy-3.4-methylenedioxyamphetarrine c 225 no change 5-Methoxy-Wadasopropynryplamine5-Methoxy-W.N-diisopropylttyplamine 225 no change 5-Melhoxy-N,N-dirnethyliryPlamine5-Melhoxy-W.W-dimethyltrypiamine 2 no change Acetykerphemethylfentanyl - Acetyl-a(o/ie-rtisthylfentanyt 2 no change Acelyldhydrocodeine Acelyldihydrocodeine 2 no change Acelylmelhadot Aceiylmeihadol 2 no change AllylprocaneAllylprodine 2 no change AlphacelylmelhadolAlphacetyimethadol 225 no change arphe-Ethyltryptaminea{aba-Elhyltoptamine 2 no change MpharneprodineAlphameprodine 2 no change Alphamethadol 2 no change elphe-Methylfentanyla/pha-Methylfentanyl 2 no change elphe-Methylthiefentanylafcha-Methylthiofentanyl 225 no change alphe-Methyltrypterninea/pba-Methyltryptamine (AMT)(AMT) 115 25 alpha-Pyrrolidinchutophenonea/pha-Ryrrolidinohuliophenorte (a(a-PBP)-:BP) 115 25 alpha-PyrrolWinopenliophenone3lpt>a-PYrr£>lklinopenllophenor>e (a-PVP) — 225 no change - ArnIncrexAmlrorex 2 no change BenzylmorphineBenzylmorphlne 2 no change eetacetylmethadolBetacotylmethadol : .. ... 2 no change beta-Hydroxy-3-methyllentanylfiera-Hydroxy-3-meihyitenlariyl 2 no change bera.Hydroxylentanylfiera-Hydroxytenlarryl 2 no changechangB SetarneprodineBetanneproaine 4 no change Betarnethadol 2 no change SetaeBetaprodlne rodhe 3 noho change &MentheBufotonina 770 no change Cath&oneCathinone 5 no change methylbremidemethyibromide Codeine 305 no change Codeine..N.oxideCodeine-N-oxide 5 25 DasomorphineOesomorphine - 25 no change DiethyltryptamlneDiethyUryptamlne 11.0001 1 ,000 no change Difenoxin 3,990.0003,990,000 no change DthydromorphineDihydromorphine - 35 no change DimethylttyptamineDimethyltryptamine 5 nochangeno change - Diplpanone 5 no change Fenethylline 1 Ferethyllino 70,250.00070,250,000 no change acidadd gamma-Hydroxyboardcgaro/na-Hydroxybutyric 25 50SO Heroin 2 no change c HydromorPhinolHyd'omorphinol Vol. I PagePage 927 Federal Register/Val.Register/ Vol. 80, No. 130/Wednesday, July 8, 2015/2015/Notices Notices 39159 Established Proposed 2015 Quotas Adjusted 2015 c Basic class Quotas (9)(9) • (9)is) HydroxypethiclineHydroxypethtdine • 2 no change 5 no change lhogaine Lysergic acid diethylamide (LSD)(LSD) I 35 no change 658,000 no °tingechange Marihuana 25 no change Mescaline no change MelhaqualoneMeihaqualone 10 no change MelhcathinoneMelhcathinorxe I 25 no change change MerhyldesorphineMethyldesorphine 5 no change Merhyld.hydrernorphineMethyldihydromorphine 2 no change 5 no change Morphine methylbrOmidemethylbromlde 5 no change Morphine methylsulfonate ...~ 5 no Mange MorphinoNoxideMorphino-W-oxide 350 no change N.(1-Adamanty1)-1-pentyl-1H-indazole-3-carboxamideN (1-Adamantyl)-1-pentyl-iH-inda2ole-3-carboxamlde (AKB48)(AKB48) 15 25 N.(1-Amino-3,3-dimerhyl-1-oxobutan-211)-1.Pentyl-1H-Indazole-3-carboxamideN {1-Amino-3,3-dimeihyi-1-oxobutan-2-yl)-1-pentyMH-indazole-3-cartioxamidB (ADB-PINACA)(ADB-PINACA) 15 25 N-(1-Amino-3.methy1-1-oxoloutan-211)-1-(441uorohenzyl)-1H-Indaz010A/-(1-Amino-3-methyI-l-oxobutari-2-yl)-1-(4-fluorobenzyl)-1H-indazole-3-carboxamide-3-carboxamide (AB-(A8- 15 25 FUBINACA). N-(1-Amino-3-methy1-1N-(1-Amino-3-methyM -oxobutan-2.y1)-1-(cyclohexylmethyl)-1H-Indazolo-3-carboxamIdeoxobutar-2-yl)-1-(cyclohexylmethyi)-i H-lndazoic-3-carboxamlde (AB-(AB- 15 no change CHMINACA). . . N-(1-Amino-3-methyl.1-oxebutan-2-y1)-1-pentyl-11AP(1.Amino-3-methyM-oxobutan-2-yl)-1-pcntyMH-indazole-3-earboxam!de-tindazolo-3-carboxam!de (AB-PINACA)(AB-PINACA) 15 no change 1,4N-ClimethylamphetarnineN.N-Dimethylamphetamine : 25 no change Naphthylpyrovalerone (naphyrone)(naphyrone) 15 25 N.BenzylpiperazineN-Benzylpiperazine - 25 no change N-Eihyl.1-phenylcyclohexylamlneW-Elhyl-1 -phenylcyctohexylamlne 5 no change 24 no change NElhylamphelamineAf-Elhylamphelamine 24 no change MHydroxy-3,4-methylenedioxyamphetamineA/-Hydroxy-3,4-meihylenedioxyamphetamine 24 no change Noracymethadol 2 no change Norlevorphanol - 52 no change Normethadone 2 no change 18 40 NorrnorphineNormorphine 113 40 Pare-fluordenianylPara-ftuorolenianyl zero 5S Parahexyl zero 5S Phenomorphan - 2 no change nholcaline zero 5 c 30 no change Psilocybin 30 no change PalocynPsilocyn 30 Claindin-811115-11uoroponly1FIffindole-3-catioxylateQuinolin-0-yl l-(5-lluoropontyl)-lH-indo1e-3-earboxylate (5Auorc-P8-22(5-lluoro-PB-22; 5F6F-PB-22)-P0-22) 15 25 Oulnolin.8.y1Quinolln-8-yl 1-peniy1-1H-Indole-3-carboxylate1-paniyt-i K-tndola-3-carboxylate (P13-22;(PB-22; QUPIC)QUP1C) 15 25 TetranydnocannabinolsTetrahydrocannabinols 497,500 511,250 ThiefThiofentanyl ant anyl 2 no change Tilidlne - , 10 25 TrImeparldineTrimeperidine 2 no change Schedule IIII 1-Phenylcyclohexylamine1-Phcnylcyclohexylamine 5S no change 1-Piperidlnocyclohexanecarbonihile1-PiperidlnocyclohexanecarbonitrUe 5 no change 4-Anilino-N-phenerhyl-4-piperidine4-Anilino-W-phenelhyl-4-piperidine (ANPP)(ANPP) 2,687,500 no change AllentanilAlfentanll 17,7501 7,750 no change MphaprodineAlphaprodine 3 no change Amobarbital 25,125 no change Amphetamine (Ion(lor conversion) 21,875,000 no change Amphetamine (for(for sale) 37,500.00037,500,000 no change Carlentanil 19 no change Cocaine 275.000275,000 no change Codeine (for(for conversion) 50,000,000 no change Codeine (for(for sale) 49,500,000 63.900,00063,900,000 Dextropropoxyphene 19 45 031ydrucodeineOihydrocodcine 226,375 no change Diphenoxylate (for(for conversion) 75.00075,000 no change OlphenoxylateDiphenoxylate (for(for sale) 1,337,500 no change Ecgonine 174,375 no change EthylrnorphineEthylmorphine 3 no change Fentanyl 2,150,000 2300,0002,300,000 ClutetdmideGlutethimide ' 3 no change Hydrocodone (lor(lor conversion) 137,500 no change HydrecodoneHydrocodone (lor(lor sale) .. 99,625,000 no change Hydromorphone 7,000,000 no change IsomethadoneIsomethadone 5 no change Leyo-alph.acetylmethadolLevo-aiphaeetylmeihadol (LAAM)(LAAM) 4 no change LevomeinorphanLevomethorphan 5 30 c 7,125 no change Levorphanol Vol. I PagePage 928 39160 Federal Register/Vol.Register/ Vol. 80, No. 130/Wednesday.130/ Wednesday. July 8.8, 20152015/Notines /Notices Established Proposed 2015 Quotas Adjusted 2015 L Basic class QuotasQuoias (9) 0) (9)(9) Lisdexamletaminelisdexamfetamlno 29,750,00029,750.000 no change meperldineMeperidine 6,260,0006,250,000 no changeCharge MeneridineMeperidine IntermediateIntermediate-A-A . 6 no change Meperidine IntermediateIntermediale-B-El . 11 32 MoporldineMeperidine IntermediateIntermediaie-C-O . 6 no change MetazocineMeiazocine 19 no change Methadone (for('or sale) 31,815,00031,675,000 no change Methadone IntermediateIntermediate 34,375,000 no changecharge MelhamphetamineMeihamphetamine 2061,3752,061,375 no changecharge 11,250000(1,250,000 grams ofol levo-desoxyephedrinelevo-dasoxyephedrlne fortor use inin a nonnon-controlled,-controlled, non-prescription product; 750750,000 000 grams fortor rnethamphetaminemethamphetamine mostly for conversion to a schedule IllIII product; and 61,375 grams for melhamphetaminemeihamphetamine (for(for sale)Isale)] Methylphenidate 133,150,00063,750,000 67,500.00007,500.000 Morphine (for(for conversion) 91,250,000 no change Morphine (for(for sale) 62,600,00062,500,000 no change NeftioneNaWione 18,75016,750 no change NoroxyrnorphoneNoroxymorphone (tor(tor conversion) . 17,500,000 no change no Noroxymorphone (tor(lor sale) 1,475,000 ro change Opium (powder)(powder) 112,500 no change Opium (tincture)(tincture) 687,500 noro change OdpavineOripavine 35.000,00035,000,OX no change OxyoodoneOxycodone (for(for conversion) 8,350,000 no change OgoodoneOxycodone (for(for sale) 137.500,000137,500,000 139,150,000139,150.000 Oxymorphone (for(for conversion) 29000,00029,000,000 no change OxymorphonoOxymorphone (for(for sale) 7,750,000 no change Pentobarbital 35,000,000 no changeChange Phone/00wPhenazoclna ... 6 no change PhencyclidinePhancyclldlne 19 38 PhenmetrazinePhenmetrazlne 3 no change PhonylacetonePhenylacetone 9,376,000S.37S.OOO no change Racemelhorphan 3 no change • 3.750 4.200 c RemitRemifentanil ardent] 3,750 4200 SecobarbilalSecobarbital 215,003 no change Sufentanil 6,2556.255 no change TapentadolTapentadai 12.50000012.500,000 no change Thebaine 125,000,000 no change List II Chemicals EphedrineEphcdrire (for(for conversion) 1,000,0001,000,MO no change Ephedrine (for(for sale) 4,000,000 no change Phenylpropanolamine (for(for conversion) 44,80000044,800,000 no change Phenylpropanolamine (for(for sale) 6.5110.0006,500,000 no change Pseudoephedrine (for(for conversion) 7,000 no change Pseudoephedrine (for(for sale) 224,500,000 no change The Acting Administrator further receivedreceived inin responseresponse tolo this notice, the phenylpropanolamine. 21 CFR proposes that aggregate production Acting Administrator may hold a public 1303.13(c) and 1315.13(fl.1315.13(f). quotas for all other schedule II and II hearing on one or more issuesissues raised.raised. 21 Dated: JulyJuly1,20l5. 1.2015. controlled substances includedincluded inin 21 CFR 1303,13(c)1303.13(c) and 1315.13(e). InIn the controlled Chuck Rosenberg.Rosenberg, CFR 1308.11 and 1308.12 remainremain at event the Acting Administrator decides Acting Administrator. zero. InIn accordance with 21 CFR to hold such a hearing, the Acting (FR(FR Doc. 2015-16699201S-16699 Filed 7-7-15;7-7-15:8:45 8:45 analaiu| 1303.13 and 21 CFR 1315.13,1315.13. upon Administrator will publish a notice of consideration of thetha relevantrelevant factors.factors, the thetha hearing inin the Federal Register. BILLING9ILUNO CODECODS P Acting Administrator may fartherfurther adjust After consideration of any comments or the 2015 aggregate production quotas objections, or after a hearing.hearing, ifif one isis and assessment of annual needs as hold, the Acting Administrator will needed. issueissue and publish inin the Federal Register a final order establishing any Comments adjustment of the 2015 aggregate InIn accordance with 21 CFR 1303.13(c) production quota for each basic class of and 1315.13(d), any interestedinterested person controlled substance and established may submit written comments on or assessment of annual needs for thetha listlist objections to thosethese proposed I1 chemicals ephedrine,ephedrine. • c determinations. Based on comments pseudoephedrine. and Vol. I PagePage 929 Drag I Cnmnanv Comment Pfllfl Cnmnanv Comment AmountAmount - ResponseResponse ProposedProposed APOARO. RevisedBtviscd APO ChantsChange • codeine (forI for sale)sale! . (b)(4)(b)(4) increaseincrease APOA PO 5,484,0005,484,000 sufficient APQAPO availableavailable 63300,00063.900.00Q - 63.900,00063.900.00Q codeinecodeine (for(for sale)sale) , increaseincrease APO 6,636.0006.636.000 • sufficientsufficient APQAPO availableavailable seesee aboveabove seesee aboveabove. see aabove Ye codeine (for(for sale)sale) codeine increase_Aincrease APO PO 3.884,0673.884.061 sufficientsufficient APQAPO availableavailable seesee aboveabove seesee aboveabove seeSee aboveabove . . fentanylfemanyl increase_AEOincrease APO 38,48538.485 sufficient APQAPO available 2,300,0002.300,000 3100.0041300.0(10 .. . oammabvdroxvbutrichvdroxvhutric acidacid eamma increaseincrease APOAPO 7.5007.SOO sufficientsufficient APQAPO availableavailable 70,250.00070.250.00(1 70.250.00070.2g0.Q0O • hydrocodonehvdrocodone (for( for sale)sale! increase APO _1 sufficientsufficient APQ available increaseJtPO ' 1.830_0001 .830.000 APO available 99,625,00099.625.000 99,625,00099.625.000 --_- methadone increaseincrease APO _ 2,718,1592.718.159 sufficient APOAPO available 31,875,00031.87S.OOO 31,875.00031.875.000 methadonemethadone intermediateintermediate increaseincrease APO 1,800,6341.800.634 sufficientsufficient APQAPO availableavailable 34,375,00034,375,000 34,375,00034.375.000 -_, methylphenidaremethylphenidate increaseincrease APQ 9,186,2369,186,236 adjust APQ 87,500,00087.500,000 96,750,00096,750,000 9,250,0009.250,000 innmorphineiirie (for(for conversion) increascAPOincrease APO 4,499,9874,499,987 sufficientsufficient APQAPO available 91,500,00091.500,000 91,500,00091.500,000 - oripavine increaseAPOincrease APO 1,823,0381,823,038 sufficientsufficient APQAPO availableavailable 35,000,0003 S,000.000 35,000.0003S.OOO.OOO - oxvcodoneoxycodone (for( for sale) increaseincrease APO 2,510,0002.510,000 adjustadjust APQAPO 139,150,000139,150,000 /4I.375,000141,375,000 2,225.000 oxmenitioneoxvmorphone (for(for conversion) inefeAscincrease APO 3,130,0003,190,000 sufficient APQAPO available 29,000,00029.000.000 29.000,00029,000.000 - oxvmorphone (for(for sale)sate! inerease_APQincrease APO 150,000150,000 sufficientsufficient APO availableavailable 7.750,0007.750,000 7,750.0007,750.000 - 1 NumberNumber of registrants/entitiesregistrants/entities commenting: 5 NumberNumher of drugs commented on: 1212 1212 r CMPACMKA Chemical Company Comnanv CommentConvncpl AmountAmount ResponseResponse Pronose,e1Pronosed AANA AN RevisedRevised AANAAIS ChangeCJjQnEE- NumberNumber of registrants/entitiesregistrants/entities commenting: 0 Number ofof ListList II chemicals commented on: 00 Additional DrugDrug Considerations: n"ruerim ResnonseResponse. ProposedProposed. RevisedRevised Change dihvdroetorphinedihvdroelornhine (b)(4)(b)(4) no available code 9334 APQdrugAPQ drug code 9334 33 . i3, ethylnkorphjneethvlmorohine nono available APQ, drug code 9190 33 55 2 morphinectorphinc HClI?CI no available APQ drug code 9059 ' - 3 33 racemracemethorpban ethomhan ' no available APQ drug code 9732 33 _S5 2 nteemorfihanracemorphan nnnn availableavailable APQ drug code 9733 - 33 33 fentanyllentanyl 1(b)(4)Mm lendingding applicationapplication #4 123706,123706, 123955123955 • 2,300,0002.300,000 see above seesee above . 1 Additional Chemical Considerations: DrugDruK ResnonseResponse Proposed Revised ChariotChange - _ • _ -** the proposed and revisedrevised values includeinc!ude25% 25% buffer for C11Cll substances 2015 Proposed Revised APQ AAN Created by 00E0OOEQ on 8-12-15 Summary ofol proposed revisedrevised comments receivedreceived as of 7-21-157-21-1 5 Vol. I PagePage 930 Lc AUGAUG 11 00 20152015. AugustAugust 6,6, 20152015 DrugDrug EnforcementEnforcement AdministrationAdministration Attention:Attention: .DEADEA FederalFederal RegisterRegister Representative/ODLRepresentative/ODL 8701870 1. MorrissetteMorrissette DriveDrive 'Springfield,Springfield, VAVA 2215222152 Subject:Subject: DocketDocket No,No, DEA-418PDEA-418P DearDear Sirs:Sirs: (b)(6) ooff (b)(6)H ] manufacturingmanufacturing registrationregistration (b)(4),(b)(7)(E) p)ffl;(b)(7)(ET|amam submittingsubmitting thisthis commentcomment onon thethe 20152015 ProposedProposed AdjustmentsAdjustments toto thethe AggregateAggregate ProductionProduction QuotaQuota forfor variousvarious productsproducts asas publishedpublished inin thethe JulyJuly 8,8, 20152015 FederalFederal Register.Register. WeWe considerconsider thethe informationinformation inin thisthis firstfirst paragraphparagraph toto bebe "PERSONAL"PERSONAL IDENTIFYINGIDENTIFYING INFORMATION"INFORMATION" andand thisthis informationinformation shouldshould not be releasedreleased under thethe Freedom ofof InformationInformation ActAct per 55 USC Sec.Sec. 552(b)(4).552(b)(4). InIn addition,addition, thethe followingfollowing informationinformation isis "CONFIDENTIAL"CONFIDENTIAL BUSINESSBUSINESS INFORMATION".INFORMATION". TheThe followingfollowing items'items' manufacturingmanufacturing quotaquota shouldshould bebe increasedincreased byby thethe identifiedidentified quantity:quantity: (i)(i) HydrocodoneHydrocodone (for(for sale)sale) by 1,830,0001,830,000 gramsgrams asas base. AsAs noted herein,herein, thisthis firstfirst paragraphparagraph ofof thisthis letterletter containscontains personalpersonal identifyingidentifying andand confidentialconfidential business c informationinformation andand shouldshould bebe redactedredacted inin itsits entiretyentirety fromfrom anyany publicpublic docket.docket. ' WeWe feelfeel thethe proposed quantitiesquantities forfor thethe material mentionedmentioned aboveabove areare notnot sufficientsufficient toto provideprovide forfor adequate suppliessupplies forfor thethe medical, scientific,scientific, researchresearch and industrialindustrial needs of thethe United States,States, andand forfor thethe lawfullawful export requirements,requirements, andand thatthat thethe quotasquotas shouldshould be increasedincreased toto covercover ourour needs. For thesethese itemsitems anan appropriateappropriate Electronic DEA QuotaQuota Application Form 189189 will be submittedsubmitted shortlyshortly pertaining toto thethe itemsitems forfor which wewe areare submittingsubmitting comments.comments. Very trulytruly yours Lc Vol. I PanePage 931 Page 1I of 1] Lc As of: 8/7/15 10:2110:21 AM Received: August 04, 201520 1 5 Status: DoNotPost PUBLIC SUBMISSIONSUBMISSION Tracking No. 1ljz-8kda-I0srjz-81ctia-10sr Comments Due: August 07, 2015 Submission Type: Web Docket: DEA-20DEA-2015-001I15-001 1 Adjustments to the Aggregate Production.Production Quotas for Schedule I and II Controlled Substances and Assessment of Annual Needs for the List I1 Chemicals Ephedrine, Pseudoephedrine, and Phenylpropanolamine for 201520 1 5 Comment On: DEA-20DEA-2015-0011-000115-001 1-0001 Proposed Adjustments toto the Aggregate Production Quotas for Schedule I and III1 Controlled Substances and Assessment of Annual Needs for the List I Chemicals Ephedrine, Pseudoephedrine, and Phenylpropanolamine for 2015201 5 - Document: DEA-20DEA-2015-0011-DRAFT-00051 5-001 l-DRAFT-0005 Comment on FR Doc # N/A r Submitter Information Name: (b)(6) General Comment Re: Comments on Proposed Adjustments to the Aggregate Production Quotas for Schedule I and II ControlledControlled. Substances and Assessment of Annual Needs for the List I Chemicals *"N Ephedrine, Pseudoephedrine, and Phenylpropanolamine for 2015 on behalf of the following • registrant: (b)(4)(b)(4) Attachments Docket No. DEA-418P|(b)(4TDEA-418P (b)(4) Comment https://www.fdms.gov/fdms/getcontent?objectld2=0900006481bcl842&format=xml&showo...https://www.fdms.gov/fdms/getcontent?objectld=0900 006481bc1842&format=xml&showo... 8/7/2015 Vol. I Page 932 (b)(4)(b)(4) AugustAugust 4,4, 20152015 DeputyDeputy AdministratorAdministrator DrugDrug EnforcementEnforcement AdministrationAdministration Washington,Washington, D.C.D.C. 2053720537 Attn:Attn: DEAPEA FederalFederal RegisterRegister ReoresentativeRepresentative [DocketfDocketNo. No. DEA-418P)PEA-41 8PI ThisThis letterletter constitutesconstitutes (b)(4) Jcomments comments onon the.tho.Proposed Proposed RevisedRevised AggregateAggregate ProductionProduction QuotasQuotas forfor 2015,201 5, asas publishedpublished inin FederalFederal RegisterRegister onon JulyJuly 8,8, 2015,2015, FRFR VolumeVolume 80,80, No.No. 130,130, pagespages 39156-39160.39156-39160. ItIt shouldshould bebe consideredconsidered toto bebe ConfidentialConfidential BusinessBusiness Information.Information. ' . InIn lightlight ofof thethe factfact thatthat|(b)(4) (b)(4) hasHias nono knowledgeknowledge ofof eithereither thethe amountsamounts ofof anyany availableavailable aggregateaggregate quotasquotas oror DEA'sDEA's plannedplanned allocationallocation ofof anyany aggregate,(b)(augregatej(b)(4)4) requestsrequests thatthat DEAPEA makemake anyany adjustmentsadjustments toto thethe aggregateaggregate quotasquotas sufficientsufficient toto satisfysatisfy ourour requestsrequests forfor increasedincreased manufacturingmanufacturing quotas,quotas, whichwhich areare outlinedoutlined below.below. BecauseBecause thisthis commentcomment containscontains proprietaryproprietary informationinformation onon ourour manufacturingmanufacturing quotaquota needs,needs, (b)(4)|(b)(4) jalsoalso requestsrequests thatthat DEAPEA treattreat thisthis entireentire documentdocument asas confidential.confidential, 5 ? AllAll requestsrequests belowbelow areare statedstated inin gramsgrams anhydrousanhydrous basebase ("AA").("AA"). 90509050 CodeineCodeine (for(for Sale)Sale) (b)(4)|(b)(4) j-eq•equestsnests thatthat thethe revisedrevised aggregateaggregate bebe sufficientsufficient toto includeinclude (b)(4)P"(4) requestrequest forfor 6,636,0006,636,000 gramsgrains AA ofof codeinecodeine (for(for Sale)Sale) manufacturing quotaquota forfor 2015,2015, referencereference DEADBA onlineonline subinissionsubmission numbernumber 123843.123843. 98019801 FentanylFentanvl (b)(4)|(b)(4) 'requests[requests thatthat thethe revisedrevised aggregateaggregate bebe sufficientsufficient toto includeinclude (b)(4)|M(4) requestrequest forfor 38,48538,485 gramsgrams AAAA ofof fentanylfentanyl manufacturingmanufacturing quotaquota forfor 2015,2015, referencereference DEADEA onlineonline submissionsubmission number 124116.1241 16. 20102010 GammaGamina HydroxybutyricHydroxybutyric AcidAcid Kb)(4)(b)(4) 'requests Requests that the revisedrevised aggregateaggregate be sufficientsufficient toto includeinclude|(b)(4) (b)(4) | request forfor 7,500 grams AA of gammagamma hydroxybutyric acid manufacturing quota forfor 2015, 3 reference DEA online submissionsubmission number 124113.1241 13. i L 3 i ContainsContains ConfidentialConfidential andand ProprietaryProprietary BusinessBusiness InformationInformation PagePage 11 ofof 22 Vol. I PagePage 933933 92509250Methadone Methadone p4)(b)(4) ]requcstsrequeststhat thatthe therevised revised aggregateaggregatebe besufficient sufficientto to includeincludeN<4> (b)(4) requestrequest forfor2,718,159 2,718,159grams gramsAA AAof ofmethadone methadonemanufacturing manufacturingquota quota forfor2015, 2015,reference reference DEADEAonline onlinesubmission submissionnumber number 1241124112.12. 91709170Methadone Methadone IntermediateIntermediate 1(b)(4)(b)(4) Irequestsrequests thatthat thetherevised revised aggregateaggregatebe be sufficientsufficientto to include!^4)include (b)(4) | requestrequest forfor 1,800,634I,800,634 gramsgrams AAAA ofofMethadone Methadone IntermediateIntermediate manufacturingmanufacturing quotaquota forfor2015, 2015, referencereference DEADEA onlineonline submissionsubmission numbernumber 1241124111.1 1 . 93309330Oripavine Oripavine |(bjffl(b)(4) Irequestsrequests thatthat thethe revisedrevised aggregateaggregate bebe sufficientsufficient toto includeinclude1(b)(4) (b)(4) requestrequest forfor 1,823,0381,823,038 gramsgrams AAAA ofoforipavine oripavine manufacturingmanufacturing quotaquota forfor 2015,2015, referencereference DEA➢EA onlineonline submissionsubmission numbernumber 1241124115.15, AllAll otherother quotaquota requestsrequests remainremain unchangedunchanged fromp<4'from (b)(4) originaloriginal request.request. Sincerely, (b)(6) L Supervisor,Supervisor, ControlledControlled SubstanceSubstance ComplianceCompliance (b)(4) I J(b)(4) (b)(6)b)(6) j(b)(4);(b)(6)1(b)(4),(b)(6) I i 1 I t i i i L i s s Page 2 of 2 ! Contains Confidential and Proprietary Business Informationinformation Page 2 of 2 f y a Vol. I PagePage 934 (b)(4)!b)(4) PagePage 1 1ofof 1 I AsAs of:of: 8/7/158/7/15 9:449:44 AMAM LL Received:Received: AugustAugust 04,04, 201520 15 Status:Status: Pending_PostPending_Post PUBLICPUBLIC SUBMISSIONSUBMISSION TrackingTracking No.No. 1Ijz-8kd8-q82kjz-8kd8-q82k CommentsComments Due:Due: AugustAugust 07,07, 201520 1 5 SubmissionSubmission Type:Type: WebWeb Docket:Docket: DEA-2015-001DEA-2015-001 I 1 AdjustmentsAdjustments toto thethe AggregateAggregate ProductionProduction QuotasQuotas forfor ScheduleSchedule I Iandand Il11 ControlledControlled SubstancesSubstances andand AssessmentAssessment ofof AnnualAnnual NeedsNeeds forfor thethe ListList 11 ChemicalsChemicals Ephedrine,Ephedrine, Pseudoephedrine,Pseudoephedrine, andand PhenylpropanolaminePhenylpropanolamine forfor 201520 15 CommentComment On:On: DEA-2015-0011-0001DEA-2015-001 1-0001 PrOposedProposed AdjustmentsAdjustments toto thethe AggregateAggregate ProductionProduction QuotasQuotas forfor ScheduleSchedule II andand IIII ControlledControlled SubstancesSubstances andand AssessmentAssessment ofof AnnualAnnual NeedsNeeds forfor thethe ListList I1 ChemicalsChemicals Ephedrine,Ephedrine, Pseudoephedrine,Pseudoephedrine, andand PhenylpropanolaminePhenylpropanolamine forfor 2015201 5 Document:Document: DEA-2015-0011-DRAFT-0003DEA-2015-001 l-DRAFT-0003 CommentComment onon FRFR DocDoc #I# N/AN/A r SubmitterSubmitter InformationInformation Name:Name: (b)(4)[(b)(4) L • Address:Address: UnitedUnited States,States, Email:Email: (b)(4)|(b)(4);(b)(6) (b)(6) GeneralGeneral CommentComment SeeSee attachedattached file(s)file(s) AttachmentsAttachments DocketDocket DEA-418PDEA-418P(b>(4* (b)(4) CommentComment https://www.fdms.gov/fdms/getcontent?objectld=0900006481bc14b7&fonnat=xml&showo...https://www.fdms.gov/fdms/getcontent?objectld=090000648 1 bcl4b7&format=xml&showo... 8/7/20158/7/20 15 Vol. I Page 935935 (b)(4);b)(4) L ConfidentialConfidential Business Information AugustAugust 4,4, 20152015 Drug Enforcement AdministrationAdministration Attn:Attn: DEA Federal Register Representative/ODW 87018701 Morrissette Drive Springfield, VirginiaVirginia 2215222152 RE;RE: Docket No. DEA-418PDEA-4-i8P TevaTeva Pharmaceuticals Comment Dear DEA Federal Register Representative, M0 1(b)(4) -] hereby requests an increaseincrease toto thethe 2015 adjusted aggregate production quota forfor codeine (for sale), CSA code 9050.|'b)(4)90501(6)(4) | believes thethe proposed new levellevel of 63.9 metric tonstons may not be adequate forfor thethe medical, scientific, research and industrial needs of thethe United States. Confidential Business Since thethe rescheduling of hydrocodone combination products fromfrom schedule IIIill toto Information schedule IIit in October 2015, thethe codeine combination products market has observed a significant increase in sales, specifically in sales of APAP/codeineAPAPicodeine combination tablets,tablets, which remain schedule Ill.III. c ,b)(4)bx™ jitself itself has observed a 70.7% increase in APAP/codeine combination tabletstablets Confidential (in termsterms of codeine base content). Our market share, per IMS, has remained Business relatively steady, indicating all manufacturers are observing similar increases in Information sales. Reference Table 1 for year-by-yearyear-by-year APAP/CodelneAPAP/Codeine tablettablet sales (kg codeine base). (b)(4) |isis requesting DEA taketake into account our sales data (in kg codeine base), and the corresponding % increase relative to 2014 sales when calculating a 2015 Final Aggregate Production Quota. b)(4) 1 20142014 sales of 4.499 MT base Confidential codeine represented 9.8% of the 2014 Final Aggregate Production Quota. Business (b)(4)(b)(4) |prcjected•rojected 2015 sales of 7.822 MT are 12.2% of the 2015 Proposed InformationInformation Adjusted• usted Aggregate Production Quota and represent a 70.7% increase over 2014 sales. To reiterate, DEA proposed adjusted aggregate of 63.9 metric tons represents an increase of justjust 38.5% over the 2014 final adjusted aggregate production quota of 46.125 MT. : • Administrative Offices: Lc ;b)(4)(b)(4) Vol. I PagePage 936 Confidential Business InformationInformation Table 1.1.1(b)(4):b)(4) |Codeine/APAPCodeine/APAP Combination Tablet Historical and Projected Sales in Terms of Codeine Base Content kgkg~~ kg kg kg ' 7kg codeine base codeine base codeine base codeine base codeine base Year 2011 (actual) 2012 (actual) 2013 (actual) 2014 (actual) 2015 (Projected) Confidential Sales 4556.151 _I 4638.9164638.9,16 4633.833 4499.7784499,778 7822.236* Business 2015 projected satessales informationInformation represent an increase of 2011-2014^X4)2011-2014 Jp)(4) jyearlyyearly codeine/APAP combination products sales 3240.067 kg base over . Notes average, inin terms of codeine base content = 4582.169 kg. 2012011-20141-2014 yearly sales average • (or 70.7%) 'Projected*Projected satessales =g 2015 sales (asfas of 30June201S)30June2015) x 3653651/ day ofof_yearyear =--- 3872.972387B.972 kg x 365/1365/121B1 = 7822.236. In addition to the commercial quota needs outlined above,plffl b)(4) lalso also plans to consume 644 kg of codeine base for site transfer purposes (development(development quota). ifIf you have any questions, please feel free to contact me at (0)(6) (b)(6)(b)(6) or by email at[(b>W;(b>(6>at (b)(4) (b)(6) Sincerely, Confidential (b)(4)(b)(4) Business (b)(6)(b)(6) InformationInformation Senior Manager DEA Compliance • Vol. I PagePage 937 Confidential BusinessBusiness InformationInformation DocketDocket No,No. DEA-418PDEA-418P 2014 andand ProjectedProjected 20152015 Acetominophen/Codeine Tablet SalesSales ;b)(4)(b)(4) 2014MUSatet 54144 PalancyPotency solulbaftle Dayay ofol YearYM' 11a4IWIStid Sold I=Altsalt {k9}(fcq) aasebasolkfl) Ikg) ACETAN1NgACETAMINOPHEN PNEN && CODEINECOCclNE TBTB 300/1514G3D0/15HG 100100 1315 100100 365365 2.22311231 40.6554Q.tS8 2929717 717 ACETAMINOPHENACETAMINOPHEN &6 CODEINECOPE3NE TBTB 3300/30MG00/ 10/40 VID130 3030 100106 365365 16.13346.1331 551779580.776 429.776479.776 ACETANINDI71191ACETAMINOPHEN && CODEINECOOHItE TB300/30MG300/10MG lowIMP 35 icon1066 365385 0,6420642] 3470943470.84 25532588496 406 ACETAMINOPHENACETAMINOPHEN &t. CODEINECODEINE 713TB 300164/403W60MG 100 boHI 100100 385365 18,2E3318J2S3] 1314.9241314.974 973.044973.644 ACETAMINOPHENACETAMINOPHEN &&C00BNE CODEINE TOT8 303L601463001E0H6 500SOP 8060 600 385 1,0451.698 1 610-26102 451.548 ACETAMINOPHACETAMINOPHEN EN &OtCODBNE CODEINE taTB 330/69M63M/60KG 10001060 60 60:10tooo 385 sofl9| 63.78S3.76 47,197 Confidential TaziTotal 6080.7816080.781 4499.7704499.771 Business InformationInformation 2015iTTTTJnrrrrti Plai Saks (JansJunJatvOun AspAval PdencyPotency vs91.1bolVeuaiisitoiCe DeyPaydTw. of Year Mn Awe UH bluebase !,cETAmINO9NENACETAMINOPHEN 6h CODEINECOOHNE TBTB 3130/ISNG30071SMS 100100 1515 1001C0 181181 18,75018.750 50.66050.868 37.49337.493 ACEACETAMINOPHEN-TAMINMIEN &5 CODEINECOOSNE TBIB 300/30MG3MQ0HG 100100. 10 100100 161181 183.638183,838 1110.9591110.859 622-110577-110 ACETAMINOPHENACETAMINOPHEN &8 CODEINECODEatE TBTB meg31W33MS P.m 1000IQQO 30I 1D001000 161181 61.09281.097 4906.8424905.842 3630.3233830,323 ACETAMINOPHENACETAMINOPHEN & CODEINE TB 300/60HG 100100 80 100100 181181 220,515228.510 2749.718 .2329.2028 132133 ACETAMINOPHEN &A CODEINE TB 300/$4P300760 MG40 500 60 500 1131181 69.36219.352 11701170 743 853888349 349 ACETAMINOPHEN &ft CODEINECOSSNE TB 300/60MG3 00160HQ 10001033 50 10001000 161151 4.8904,590 691.603691.883 437.831437831 Total 10570.54210570.592 7622.2187522238 Lc Lc Vol. I Page 938 L (b)(4)(b)(4) (b)(4)(b)(4) July 31,31, 20152015 Drug Enforcement Administration DEA Federal Register RepresentativelODLRepresentative/ODL 8701 MorrissetteMoirissette Drive Springfield, Virginia 22152 RE: Docket No. DEA-418P Noramco Comment toto Federal Register Volume 80, Number 130/Wednesday,130/Wednesday, July 8,8, 2015 Notices Pages 39156-39160 FR Doc No: 2015-16699 Dear DEA Federal Register Representative: (b)(4) 1(b)(4) _ perewith1herewith comment to a portion of the above referenced Federal Register proposal. Specifically,Specifically",|(b)(4) (b)(4) 1 believes that 2015 Proposed ( Aggregate Production Quotas forfor Schedule I and TIII Controlled Substances and Assessment of L Annual Needs for the List I Chemicals Ephedrine, Pseudoephedrine, and Phenylpropanolamine for the listed drugdrag codes below may not be adequate for thethe medical, scientific, research and industrial needs of the United States.States. Drug Drug Code Methylphenidate 17241724 Codeine 9050 Morphine for Conversion 9300 OxymorphoneQxymorphone for Conversion 9652 OxymorphoneQxymorphone 9652 Retards,ds (b)(6)(b)(6) Director,'rector, Controlledontro Substanceu stance complianceompliance Lc Vol. I Page 939939 (b)(4)I))(4) (b)(4);(b)(6);b1(4)(b)(6) Drug Enforcement Administration * Attn: DEA Federal Register Representative/ODLRepress ntative/ODL 8701 Morrissette Drive Springfield, VA 2212215252 July 15, 2015 Subject:Subject Docket No. DEA-418FDEA-418P - Oxycodone (for sale) Dear Federal Register Representative, "PERSONAL IDENTIFYING INFORMATION" to be redacted isIs P><4>(b)(4) [(b)(4)(b)(4) (registrationregistration number |(b)(4);(b)(7)(E)(b)(4) (b)(7)(E) ("CONFIDENTIAL"CONFIDENTIAL BUSINESS INFORMATION"INFORMATION" to be redacted includes increased sales volumes from 694 kg (624{624 kg as base) inin 2014 to 2,469 kg (2,222 kg as base) in 2015 and a 33% manufacturing loss. pw'b)(4) (isis a registered manufacturer p>)(4);(b)(7)(E)(b)(4) (b)(7)(E) |ofof Oxycodone (for sale). 1(b)(4)(b)(4) lis is providing comment to the Proposed Adjustments to the Aggregate Production Quota for 2015 for Oxycodone (for sale) based on the information provided below. On June 12, 2015,;b){2015,Tb>ffi4) Irequestedrequested an Increaseincrease of 3,514 kg inin itsits 2015 Oxycodone (for(for sale) manufacturing quota over its then granted quota of 2,510 kg. On June 29, 2015, [(b)(4)(b)(4) was only granted an increase of 1,0041 ,004 kg "due to the limitations of the currently established aggregate production quota, no additional oxycodone (for safe)sale) can be authorized at this time.' p4)b)(4) " |wasas granted 502 kg for a new high ABUK process and 502 kg for our regularregular lowlow impuimpurity ty material. One batch of Oxycodone BaseBase which consumes 502 kg of quota will yieldield -375—375 kg (337.5 kg as base) of saleable Oxycodone HCI, Low impurityImpurity material.material.^4) (b)(4) |hashas 545 kg (490.5 kg as base) of lowlow impurityimpurity sales for fourth quarter 2015 and currently has no saleable lowlow impurityimpurity inventory.inventory. (b)(4)(b)(4) ~~jss requestingrequesting that the aaggregate r ate production quota for Oxycodone (for(for sale) be increasIncreased by 1,5061.506 kg to allowallowpW (b)(4) (toa makemake-three three additional batches. These batches will bebe used to meet the balance oof 201520.15 sasales es plus January through April 2016 sales of 10401040 kg (936(936 kg as base). i. A table detailing customers' registrationregistration numbers,numbers, their actual year to date purchases, their c open '20120155 purchase orders and their forecastsforecasts for the balance of 2015 was provided to DEADEA with our quota requestrequest ReferenceReference # 123773.123773. Vol. IPagePage 940 (b)(4)(b)(4) 2/2 L Inla your calculations itit isis importantimportant toto rememberremember that therethere isis an —33%~33% manufacturing lossloss between the point that DEADEA requiresrequires [WW(b)(4) |toto count quota as consumed and the finalfinal saleable product. Therefore, thethe additional 1,5061 ,506 kg of quota toto be requestedrequested will only yield approximately 1,1251,125 kgkg (1,012.5(1,012.5 kgkg as base)base) of saleable product.product. ;b1(4);b)(4) respectfullyrespectfully requestsrequests that thethe 2015 aggregateaggregate productionproduction quota forfor Oxycodone (for(for sale) bebe increasedincreased byby at leastleast 1,506,0001,506,000 grams toto allow forfor itsits request,request, ifIf you havehave anyany questions or requirerequire additionaladditional information,information, pleaseplease feelfeel freefree toto contact meme directly.directly. Sincerely,Sincerely, (b)(4)(b)(4) (b)(6)(b)(6) DEADEA Compliance ManagerMenagar LL (b)(6)per Lc Vol. IPagePage 941941 y / ^ •- (b)(4)(b)(4) 'AUGAlt 00 77 kir?) Drug Enforcement AdministrationAdministration (b)(4);(b)(6)(b)(4),(b)(6) Attn:Attn: DEA Federal Register Representative/ODLRepresentative/DDL 87018701 Morrissette Drive Springfield, VAVA 2215222152 AugustAugust 5,5, 20152015 Subject: Docket No. DEA-41DEA-418P8P -— Oxycodone (for sale) AMENDEDAMENDED Dear Federal Register Representative, "PERSONAL IDENTIFYING INFORMATION" to be redacted isp'Wis (b)(4) L (b)(4)W(4) Jegistration'egistration numberl(b)(4);(b)(7)(E)numberl(b)(4),(b)(7)(E) ~~| "CONFIDENTIAL BUSINESS INFORMATION" toto be redacted includes increased sales volumes fromfrom 694 kg (624 kg as base) in 2014 to 3,862 kg (3,476 kg as base) in 2015 and a 33% manufacturing loss.loss, j(b)(4);(b)(7)(E)(b)(4) (b)(7)(E) jsis a registeredregjStered manufacturer |(b)(4):(b)(7)(E) (b)(4) (b)(7)(E) | of Oxycodone (for sale).|WWsale). (b)(4) lisis providing comment to the Proposed Adjustments to the Aggregate Production Quota for 2015 for Oxycodone (for sale) based on the information provided below, On June 12, 2012015,S, |(b)<4) (b)(4) [requestedrequested an increase of 3,514 kg in its 2015 Oxycodone (for sale) manufacturing quota over its then granted quota of 2,510 kg. On June 29, 2015, IWffl(b)(4) I was only granted an increase of 1,004 kg "due to the limitations of the currently established aggregate production quota, no additional oxycodone (for sale) can be authorized at this time." (WW(b)(4) |waswas granted 502 kg for a new high ABUK process and '502502 kg for our regular low impurity material. ItIt is important to remember that there is an -33%—33% manufacturing loss between the point that DEAPEA requiresl(b)(4)requires^ jtoto count quota as consumed and the final saleable product. Therefore, one batch of Oxycodone Base consumes 502 kg of quota but yields only -375—375 kg (337.5 kg as base) of saleable Oxycodone Hydrochloride, Low ImpurityImpurity material. On July 27, p4)(b)(4) | received a purchase order for 15001 500 kg for lowlow impurityimpurity material for fourth quarter 2015. A copy will be provided to DEA with the quota application. Purchase orders for fourth quarter total 1,5401,540 kg (1,386 kg as base) for lowlow impurity material. |(b)(4)(b)(4) [currentlycurrently has no saleable lowlow impurityimpurity inventory.inventory. L ((b)(4)(b)(4) (iss requestingrequesting that the a•aggregate regate production quota for Oxycodone (for(for sale) be increase•increased by 2,510 kg to allow [(b)(4)b)(4) [toto makemake five additional batches. These batches plus Vol. IPagePage 942 } (b)(4)(b)(4) 2122/2 L thethe oneone batchbatch grantedgranted atat thethe endend ofof JuneJune willwill yieldyield —2,250~2,25G kgkg ofof saleablesaleable product.product. SeeSee tabletable belowbelow forfor inventoryinventory numbers.numbers. . . MVMPitilie.iiidiiiiiiii.i . ''. -: '4 ,M4*- .' ? '• HlghfABUKCi;Iiiii*BUK 11 .. !,:`,$, ...-, OpenOpen 20152015 PO'sPO s 15401540 I kgkg MakeMake 375375 kg 20152015 ForecastForecast 205205 kgkg :SellSell 160160 kg 20162016 Q1Q1 SafesSales 500500 kgk£ AvailableAvailable 215215 kgM TotalTotal SalesSales 22452245 kg MakeMake 66 batchesbatches 22502250 kg BalanceBalance 55 kgkg AA tabletable detailingdetailing customers'customers' registrationregistration numbers,numbers,, theirtheir actualactual yearyear toto datedate purchases,purchases, theirtheir openopen 20152015 purchasepurchase ordersorders andand theirtheir forecastsforecasts forfor thethe balancebalance ofof 20152015 was providedprovided toto DEADEA with quotaquota requestrequest ReferenceReference ## 123773.123773. AnAn updatedupdated eversionversion will bebe providedprovided with thethe nextnext quotaquota request.request. (b)(4):t»(4> Irespectfullyrespectfully requestsrequests thatthat thethe 20152015 aggregateaggregate productionproduction quotaquota forfor OxycodoneOxycodone (for(for L sale)sale) bebe increasedincreased byby atat leastleast 2,510,0002,510,000 gramsgrams toto allowallow forfor itsits request.request. IfIf youyou havehave anyany quettionsquestions oror requirerequire additionaladditional information,information, pleaseplease feelfeel freefree toto contactcontact meme directly.directly. .. Sincerely,Sincerely, . (b)(4)(b)(4) (b)(6)(b)(6) DEADEA Compliance ManagerManager (b)(6)(b)(6) J c Vol. I PagePage 943943 "w) DataData DEA DrugDrug Quota RequestRequoat 1010 Status Submitted Quota Typo Number Company DrugDrug NanaNamo CodeCode Year RequestedRequested Quota Currant Quota frientaseiDecreaseIn ere otoTDeeree fta (b)(4)(b)(4);(b)(7)(E) (b)(7)(E) 4-AN1LINO-N-PKENETHYL-4-4-ANILINO-N-PHENETHYL-4- 123712123712 PendingPonding 0202-JUN-15-JUN-15 MAN PIPEIRIDINEPIPERIOINE (ANPP)(ANPP) 8.8333-0-333.0 2015 235,490.000235,400.000 215,000.000 20,400.000 123843123843 New 2525-JUN-15-JUN-15 MAN CODEINE (FOR(FOR SALE) saso-£39050-6 2015201 S 20,000,0'00.00020,000,000.000 13,363,697.00013,363,697.000 8,638,303.0006,636,303.000 124044124044 NewNew 22-JUL-1522-JUL-1S MANMAN CODEINE (FOR(FOR SALE)SALE) 9050-B90S0-B 20152015 27,251,000.000 21,767,000.00021,767,000.000 5,484,000.0005,484,000.000 12,120,303.00012,120,303.000 124116124116 NOWNew • 04-AUG,1504-AUG-1 5 MAN . FENTANYLFENTANYL j • 9801-09801 -O 20152015 910,000.000910,000.000 071.515.000671 ,515,000 38.485.00038,435.000 1 65$ (b)(4);(b)(7)(E)[b)(4);(b)(7)(E) 123955123S55 NewNew 09-1UL-15OO-JUL-15 MAN'MAN FENTANYLFENTANYL 9301.09801-0 20152015 195,800.000195,800.000 136,000.000136,000.000 59,600.00059.600.000 98,285.00098,285.000 124113124113 Now 04-AUG-1504-AUG-15"- MANMAN GAMMA HYDROXYBUTYRICHYDROXYSUTYRIC ACID 2010-020104) 2015 7,500.0007,500.000 .. 0.000O.OQO 7,500.0007,500.000 124014124014 PendingPending 16•JUL-151S-JUL-15 MANMAN HYDROCODONEHYDROCODONE (FOR(FOR SALE) 9193-8 2015 5,900.000 5,900.0005.900.000 0.0000.000 124163124163 New 04-AUG-1508-AUG-15 MAN HYDROCODONEHYDROCODONE (FOR(FOR SALE)SALE) 9193.89193-B 20152015 2,481,653.0002,461,653.000 -"1241,653.000 1,241,653.000 1,220,000.0001.220,0004300 124112124112 New 04-AUG-1504-AUG-1S MAN METHADONEMETHADONE 9250-09250-0 2015 14,100,000.00014.100.000.000 11.381,84/.00011.381,841.000 2,718,153.0002.718.159.000 L- 1241111241 1 1 New 04-AUG-15 `-MAN METHADONEMETHADONE-INTERMEDIATE-INTERMEDIATE 9254-0 2015 16,000,000.00016,000,000.000 14.199.386.00014,199.368.000 1,800,634.0001,800,634.000 r 1 124038124038 PendingPending 22-JUL-1522-JUL-1E MANMAN METHYLPHENIDATEMETHYLPHENIDATE 1724-01724-0 20152015 28,187,000.00028,187,000.000 27,949,764.00027,949,764.000 237,238.000237,236.000 % 237,238.000237,236.000 1124042 24042 NewNow 22-JUL-1522-JUL-15 MANMAN MORPHINE (FOR(FOR CONVERSION)CONVERSION) 9300-A9300-A 2015 23,501,000.00023,501 ,000.000 19,001,01319,001,013.000 000 4,499,987.0004,499,987.000 NOROXYMORPHONE (FOR(FOR 124061124061 NewNew 23-JUL-15 MAN CONVERSION) 9668-A9668-A 2015 1,329,285.0001,329,285.000 729,265.000 600,020.000600,000.000 (b)(4);(b)(7)(E)(b)(4);(b)(7)(E) 124126124126 NewNew 05-AUG-1505-AUG-15 MANMAN ORIPAVINE 9330-09330-0 20152015 12,300,000.00012,300,000.000 10,476,96200010,476,962.000 1,023,034.0001,823,038.000 124161124181 New 07-AUG-1507-AUG-1 5 MAN OXYCODONE (FOR(FOR SALE) 9143-89143-B 2015201S 6,024,000.0006,024,000:<100 3,514,000.0003,514.000.000 2,510,000.000 2,510,000.000 OXYMOROXYMORPHONE PHONE (FOR(FOR 124049124049 PendingPonding 22-JUL-1522-JUL-15 MANMAN CONVERSION) 9652-A9652-A 20152015 5,456,000.000S.456.000.000 2,268,000.0002,268,000.000 3,190,000.0003,190,000.000 20152015 pendingpanding MOMQ requestsrequests asas ofof 8-10-158-10-15 Vol. I PagePage 944 ; , IMSIMS data 2012-2015 (jun)(jun) opiate salts est year 2012 2013 2014 6months 2015 est year Molecule 2015 KG KG KG KG KG c CODEINE 22,756.728122j756.7281 21,747.808821,747.8089 21,719.2066 13,853.5453 27,707.0906 HYDROCODONE 63,179.5151 61,711.0281 56,376.7266S6, 376.7266 24,594.5385 49,189.077 HYDROMORPHONE , ' 1,913.0402 1,927.6179 1,834.5971 852.8523 1705.7046 MORPHINE . 26,706.443128)706.4431 . 26,272.7352 24,604.3908 11,924.7271 23,849.4542 OXYCODONE =1:'66,704.849.66^704.849 60,357.3128 58,914.83 29,802.5075 59,605.015 OXYMORPHONE 1,958.2805 1;863.40051,863.4005 1,930.5344 980.6512 1961.3024 r with c.f. 2012 2013 2014 2015 2015 est.est Molecule %o/o chgehg KG.KG KG • KG KG KG CODEINE .. 16,839.978816,839.9788 16,093.3785 16,072.2129 10,251.6235 20,503.247 27.6% HYDROCODONEHYOROCODONE i' 38,539.5042 37,643.7271 34,389.8032 15,002,668515,002.6685 30,005.337 -12.7% HYDROMORPHONE 1,702.6058 1,715.5799 1,632.7914 759,0385 1,518.0771 -7.0% MORPHINE 21,529.8323 19,704.5514 18,453.2931 8,943.54538,943. 54S3 17,887.0907 -3.1% OXYCODONE 60,034.364 54,321.582 53,023.347 26,822.25726,622.257 53,644.514 1.2% OXYMORPHONE 1,742.8696 1,658,4264 1,718.1756 872.7796 1,745.55911,74S.SS91 1.6% KG Audit from July 2009 to June 2015.201S. - / A. IncludesIncludes all available columns. | ltle'Itle NSP KG L4^ 'ub Title Audit NSPKG --— Report Filters ---— Molecule CODEINE, HYDROCODONE, HYDROMORPHONE, MORPHINE, OXYCODONE, OXYMORPHONE, restrictedrestricted to: 4.4- HYDROXYBUTYRIC ACID, ALPENTANIL,ALFENTANIL, ALPRAZOLAM, AMOBARBITAL,AMO0ARBITAL, ATOMOXETINE, BELLADONA,BEILADONA, BENZPHETAMINE, BUPRENORPHINE, BUPROPION, BUTABARBITAL,8UTABARBITAL, BUTALBITAL, BUTORPHANOL, CAREINOYAMINE,CARBINOXAMIN6, CARISOPRODOL, CHLORAL HYDRATE, CHLORDIAZEPDXIDE,CHLORDIAZEPOXIDE, CLONAZEPAM, CLORAZEPATE, COCAINE, CODEINE, CYCLOBENZAPR/NE,CYCLODENZAPRINE, DEXMETHYLPHENIDATE, DECROAMPHETAMINE,DEXTROAMPHETAMINE, DEKTROMETHORPHAN,DEXTROMETHORPHAN, DIAZEPAM, DICHLORALPHENAZONE,D1CHLORALPHENAZONE, DIETHYLPROPION,D2ETHYLPROPION, DIFENOXIN, DIHYDROCODEINE, DIPHENtITORAMINE,DIPHENHYDRAMINE, DIPHENOXYLATE, DRONABINOL, EPHEDRINE,EPHEDR1NE, ESTAZOLAM, ESZOPICLONE, 55NTANTL,FENTANYL, FLUOXETINE, FLUOXYMESTERONE, FLURAZEPAM,aURAZEPAM, FOSPROPOFOL, GABAPENT1N,GABAPENTIN, HYDROCODONE, HYDROMORPHONE, KETAMINE, lACOSAMIDE,LACOSAMIDE, LEVORPHANOL, USDEXAMFETAMINE,LISDEXAMFETAMINE, LORAZEPAM, LORCASERIN, MEPERIDINE, MEPROBAMATE, METHADONE, METHAMPHETAMINE, METHOHDETAL,METHOHEXITAL, METHYLPHENIDATE,M ETHYLPHENIDATE, METHYLPHENOBARBITAL, METHYLTESTOSTERONE, MIDAZOLAM, MODAFINIL, MORPHINE, NABILONE, NALBUPHINE, NALOXONE, NALTREXONE, NANDROLONE, OPIUM, OXANDROLONE, OXAZEPAM, OXYCODONE, OXYMETHOLONE, OXYMORPHONE, PEMOLINE, PENTAZOCINE, PENTOBARBITAL, PERAMPANEL, PHENDIMETRAZINE,PHENDIMETRAZ1NE, PHENOBARBITAL,PHENOBARBrTAL, PHENTERMINE, PHENYLEPHRINE, PHENYLPROPANOLAMINE, PREGABAUN, PROPOFOL, PROPDXYPHPROPOXYPHENE, ENE, PSEUDOEPHEDRINE, QUAZEPAM, REMIFENTANIL,RE MI FENTANIL, RETIGABINE, SECOBARBITAL, SIBUTRAMINE, STANOZOLOI.,STANOZOLOL, SOPENTANIL,SUFENTANIL, SUVOREXANT, TAPENTADOL,TAPcNTADOL, TEMAZEPAM, TESTOSTERONE, THIOPENTAL, TRAMADOL, TRIAZOLAM, ZALEPLON, ZOLPIDEM Month 2012, 2013, 2014, 2015 . r DEA Confidential created 8-3-15 Vol. I PagePage 945 2015 Final Adjusted Aggregate Production Quotas and Annual Assessment of Needs L (CSA)(CSA) requiresrequires the Attorney. General to establish the • Section 306(a) of the Controlled Substances Act production amountamount- of each basic class of Schedule II and IIII controlled substances and for the List II chemicals ephedrine; pseudoephedrine, and phenylpropanolamine. This responsibilityresponsibility has been delegated to the Administrator of the DrugDrug EnforcementEnforcement Administration (DEA).(DEA). • DEA regulations allow the Administrator to revise the established annual aggregate production quota (APQ) and assessment of annual needs (AAN) after review of pertinent informationinformation provided from various sources includingincluding DEA-registeredDEA-registercd manufacturers and the Food and Drug Administration (FDA).(FDA). • The attached Federal Register notice, prepared for your signature, reflectsreflects the calendar year 201520 15 final adjusted aggregate production quotas (APQ)(APQ) for schedules II and IIII controlled substances and assessment of annual needs (AAN)(AAN) for the listlist II chemicals ephedrine, phenylpropanolamine, and pseudoephedrine for which the UnitedUnited States has medical, scientific, industrial,industrial, export and reservereserve stock requirements. • As stated inin the 201320 1 3 Federal Register Notices, DEA continues to add an additional 25% to the APQ for schedule IIII substances and those schedule II substances that arearc used to produce drugs that have a medical need (specifically,(specifically, OHSGHB and tetrahydrocannabinols) to prevent potential drug shortage issues.issues. • ExpeditiousExpeditious reviewreview and publication of this notice isis necessary to ensure an uninterruptable supply of schedule I1 and IIII controlled substances as well as listlist II chemicals ephedrine, phenylpropanolamine, and pseudoephedrine for the legitimatelegitimate medical, scientific, industrial,industrial, and export requirementsrequirements of the L U.S.U.S. • The following points provide brief explanations of the changes from the proposed revisedreyised AAN & APQ values: List 11 Chemicals: •« No further adjustments Controlled Substances: • OD isis recommending an increaseincrease inin the APQs for Dihydroetorphine, Ethylmorphine, Etorphine HCI, Racemethorphan,Racemcthorphan, Racemorphan. The increaseincrease isis based on registrant applications and,and projected demand for referencereference standards. • OD isis recommendingrecommending an increaseincrease inin the APQ for Methylphenidate based on the FDAFDA downgrading the efficacy ratingrating for two generic manufacturers of the brand Concerta® .. This change isis to allow the remainingremaining authorized generic and brand manufacturers to supply the entire domestic market. This will avert a possible shortage due to APQ limitations.limitations. • OD isis recommending an increaseincrease inin the APQ for Oxycodone (for sale). The increaseincrease isis based on additional new purchase orders and batch size requirements at thethe. bulk manufacturer level.level. OD/ODQ/ODEQ 8/17/15 PagePage 11 of 11 Vol. I PagePage 946 LL BillingBilling CodeCode4410-09-P 4410-09-P DEPARTMENTDEPARTMENT OFOF JUSTICEJUSTICE DrugDrug EnforcementEnforcement AdministrationAdministration [Docket[Docket No.No. DEA-418F]DEA-418F] FinalFinal AdjustedAdjusted AggregateAggregate ProductionProduction QuotasQuotas forfor ScheduleSchedule .II andand IIII ControlledControlled SubstancesSubstances andand AssessmentAssessment ofof AnnualAnnual NeedsNeeds forfor thethe ListList II ChemicalsChemicals Ephedrine,Ephedrine, Pseudoephedrine,Pseudoephedrine, andand PhenylpropanolaminePhenylpropanolamine forfor 20152015 AGENCY:AGENCY: DrugDrug EnforcementEnforcement Administration,Administration, DepartmentDepartment ofof Justice.Justice. ACTION:ACTION: FinalFinal order.order. SUMMARY:SUMMARY: ThisThis finalfinal orderorder establishesestablishes thethe finalfinal adjustedadjusted 20152015 aggregateaggregate productionproduction quotasquotas forfor controlledcontrolled substancessubstances inin schedulesschedules 1I andand IIII ofof thethe ControlledControlled SubstancesSubstances ActAct L andand thethe assessmentassessment ofof annualannual needsneeds forfor thethe listlist I1 chemicalschemicals ephedrine,ephedrine, pseudoephedrine,pseudoephedrine, andand phenylpropanolamine.phenylpropanolamine. DATES:DATES: ThisThis orderorder isis effectiveeffective [INSERT[INSERT DATEDATE OFOF PUBLICATIONPUBLICATION ININ THETHE FEDERALFEDERAL REGISTER].REGISTER]. FORFOR FURTHERFURTHER INFORMATIONINFORMATION CONTACT:CONTACT: JohnJohn R.R. Scherbenske,Scherbenske, OfficeOffice ofof DiversionDiversion Control,Control, DrugDrug EnforcementEnforcement Administration,Administration, 87018701 MorrissetteMorrissette Drive,Drive, Springfield,Springfield, VirginiaVirginia 22152;22152; Telephone:Telephone: (202)(202) 598-6812.598-6812. SUPPLEMENTARYSUPPLEMENTARY INFORMATION:INFORMATION: LegalLegal AuthorityAuthority TheThe DrugDrug EnforcementEnforcement AdministrationAdministration (DEA)(DEA) implementsimplements andand enforcesenforces titlestitles IIII andand 111III of thethe Comprehensive Drug Abuse Prevention andand Control Act of 1970,1 970, asas amended.amended. L 2121 U.S.C.U.S.C. 801-971.801-971. TitlesTitles HII andand IIIIII areare referredreferred toto asas thethe "Controlled"Controlled SubstancesSubstances Act"Act" 11 Vol. I Page 947947 ( andand thethe "Controlled"Controlled SubstancesSubstances ImportImport andand ExportExport Act,"Act," respectively,respectively, andand areare L collectivelycollectively referredreferred toto asas thethe "Controlled"Controlled SubstancesSubstances Act"Act" oror thethe "CSA""CSA" forfor thethe purposespurposes ofof thisthis action.action. TheThe DEADEA publishespublishes thethe implementingimplementing regulationsregulations forfor thesethese statutesstatutes inin titletitle 2121 ofof thethe CodeCode ofof FederalFederal RegulationsRegulations (CFR),(CFR), chapterchapter II.II. TheThe CSACSA andand itsits implementingimplementing regulationsregulations areare designeddesigned toto prevent,prevent, detect,detect, andand eliminateeliminate thethe diversiondiversion ofof controlledcontrolled substancessubstances andand listedlisted chemicalschemicals intointo thethe illicitillicit marketmarket whilewhile providingproviding forfor thethe legitimatelegitimate medical,medical, scientific, research,research, andand industrialindustrial needsneeds ofof thethe UnitedUnited States.States. ControlledControlled substances havehave thethe potentialpotential forfor abuse and dependencedependence and are controlledcontrolled toto protectprotect thethe publicpublic healthhealth andand safety.safety. SectionSection 306306 ofof thethe CSACSA (21(21 U.S.C.U.S.C. 826) requiresrequires thethe AttorneyAttorney GeneralGeneral toto establishestablish aggregate production quotas for each basic class of controlled substance listedlisted inin and phenylpropanolamine. This L schedules II and II and for ephedrine, pseudoephedrine, and phenylpropanolamine. This responsibilityresponsibility hashas beenbeen delegated toto thethe AdministratorAdministrator of thethe DEA. 28 CFR 0.100(b). Background The DEA established the initial 2015 aggregate production quotas for controlled substances in schedules I and II and thethe assessment of annual needs for thethe list II chemicals ephedrine, pseudoephedrine, and phenylpropanolamine on September 8,8,2014. 2014. 79 FR 53216. That notice stated that the DEA could adjust, as needed, the established aggregate production quotas and assessment of animalannual needs in accordance with 21 CFR 1303.131303.13 andand21 21 CFRCFR1315.13. 1315.13. The proposed adjusted 2015 aggregate production quotas for controlled substances in schedules I and II and assessment of annual needs for the list I chemicals ephedrine, pseudoephedrine, and phenylpropanolamine were subsequentlysubsequendy published in the Federal Register on July 8, 2015, 80 FR 39156, in consideration of the 2 Vol. I Page 948 c outlined criteria. All interested persons were invited to comment on or object to the proposed adjusted 201520 1 5 aggregate production quotas and assessment of annual needs on or before August 7, 2015. Analysis for Final Adjusted 2015 Aggregate Production Quotas and Assessment of Annual Needs Consideration has been given to the criteria outlined in (hethe July 8, 2015, notice.ofnotice of proposed adjusted aggregate production quotas and assessment of annual needs, 80 FR 39156, in accordance with 21 CFR 1303.13 and 21 CFR 1315.13.1315.13. Five companies submitted timely comments regarding twelve schedule I and II controlled substances. These comments suggested that the proposed adjusted aggregate production quotas for codeine (for sale), fentanyl, gamma hydroxybutric acid, hydrocodone (for sale), , methadone, methadone intermediate, methylphenidate, morphine (for(for conversion), c methadone, methadone oripavine, oxycodone (for sale), oxymorphone (for conversion), and oxymorphone (for sale)sale) were insufficient to provide for the estimated medical, scientific, research, and industrialindustrial needs of the United States, for export requirements, and for the establishment and maintenance of reserve stocks. The DEA did not receive any comments related to thethe proposal not toto adjust,theadjust.the 201520 1 5 assessment of annual needs for ephedrine, pseudoephedrine, and phenylpropanolamine. * In accordance with 21 CFR 1303.13,1303.13, the DEA has taken into consideration the above comments alongalong with thethe relevant 2014 year-end inventories,inventories, initialinitial 2015 manufacturing and import quotas, 2015 export requirements, actual and projected 2015 sales, research and product development requirements, and the additional quota applications received. Upon consideration of the above, the Administrator determined that the proposed 3 Vol. I Page 949949 L adjustedadjusted 2020151 5 aggregateaggregate productionproduction quotasquotas forfor dihydroetorphine,dihydroetorphine, ethylmorphine,ethylmorphine, etorphineetorphine HC1,MCI, racemethorphan,racemethorphan, racemorphan,racemorphan, methylphenidate,methylphenidate, andand oxycodoneoxycodone (for(for sale)sale) requiredrequired additionaladditional considerationconsideration andand herebyhereby furtherfurther adjustsadjusts thethe proposedproposed 20120155 aggregateaggregate productionproduction quotasquotas forfor thesethese substances.substances. RegardingRegarding codeinecodeine (for(for sale),sale), fentanyl,fentanyl, gammagamma hydroxybutrichydroxybutric acid,acid, hydrocodonehydrocodone (for(for sale),sale), methadone,methadone, methadonemethadone intermediate,intermediate, morphinemorphine (for(for conversion),conversion), oripavine,oripavine, oxymorphoneoxymorphone (for(for conversion),conversion), and oxymorphoneoxymorphone . (for sale) thethe AdministratorAdministrator herebyhereby determinesdetermines thatthat thethe proposedproposed adjusted 2015 aggregate productionproduction quotasquotas forfor thesethese substancessubstances asas publishedpublished inin thethe FederalFederal RegisterRegister onon JulyJuly 8,8, 2015,2015, 80 FRFR 39156,39156, areare sufficient toto meetmeet thethe currentcurrent 20152015 estimatedestimated medical,medical, scientific, research,research, andand industrialindustrial needsneeds ofof thethe UnitedUnited States andand toto provideprovide forfor adequateadequate reservereserve stock. c As described in the previouslypreviously publishedpublished notice establishing the 2015 aggregate productionproduction quotas and assessment of annual needs,needs, thethe DEA hashas specifically considered thatthat inventoryinventory allowances granted toto individualindividual manufacturers may riotnot always resultresult inin the availability of sufficient quantities to maintain an adequate reserve stock pursuant to 21 U.S.C. 826(a), as intended. See 21 CFR 1303.24. This would be concerning if a natural disaster or other unforeseen event resulted in substantial disruption to the amount of controlled substances available to provide for legitimate public need. As such, the DEA included in all schedule 11II aggregate production quotas, and certain schedule ]1 aggregate production quotas, an additional 25% of the estimated medical, scientific, and research needs as part of the amount necessary to ensure the establishment and maintenance of reserve stocks. The final established aggregate production quotas will reflect these included amounts. This action will not affect the ability of manufacturers to c 4 Vol. I Page 950 Lc maintainmaintain inventoryinventory allowancesallowances asas specifiedspecified byby regulation.regulation. TheThe DEADEA expectsexpects thatthat maintainingmaintaining thisthis reservereserve inin certaincertain establishedestablished aggregateaggregate productionproduction quotasquotas willwill mitigatemitigate adverseadverse publicpublic effectseffects ifif anan unforeseenunforeseen eventevent resultsresults inin substantialsubstantial disruptiondisruption toto thethe amountamount ofof controlledcontrolled substancessubstances availableavailable toto provideprovide forfor legitimatelegitimate publicpublic need,need, asas determineddetermined byby thethe DEA.DEA. TheThe DEADEA doesdoes notnot anticipateanticipate utilizingutilizing thethe reservereserve inin thethe absenceabsence ofof thesethese circumstances.circumstances. PursuantPursuant toto thethe above,above, thethe AdministratorAdministrator herebyhereby finalizesfinalizes thethe 20120155 aggregateaggregate productionproduction quotasquotas forfor thethe followingfollowing schedule II and IIII controlledcontrolled substances'substanceS and thethe 20152015 assessment of annual needsneeds forfor thethe listlist II chemicalschemicals ephedrine,ephedrine, pseudoephedrine,pseudoephedrine, and phenylpropanolamine,phenylpropanolamine, expressedexpressed inin gramsgrams ofof anhydrousanhydrous acidacid oror base,base, asas follows:follows: Final Adjusted Basic class 2015 Quotas (g) Schedule I (l-Pentyl-lH-indol-3-yl)(2,2,3,3-tetramethylcyclopropyL)methanonc(UR-(l-Pentyl-IFI-indol-3-y1)(2,2,3,3-tetramethylcyclopropypmethanone (UR- 25 144) 25 [1-[l-(5-Fluoro-pentyl)-lH-indoI-3-yl](2, (5-Fluoro-penty1)-1H-indo1-3-yl](2,2,3,3-2,3,3- 25 y tetramethylcyclopropyi)mcthanonctetramethylcyclopropyfimetharione (XLR1(XLRI 1)I) [fl-(5-fluoropenty1)41-1-indazol-3-yllinaphthalen-l-yemethanone1 -(5-fluoropentyl> 1 H-indazol-3-yl](naphthalen- 1 -yl)methanone (TH(TH5—J- 15 v 2201) : 1-(1,3-Benzodioxo1-5-y1)-2-(methylamino)butan-l-onel-(li3-Benzodioxol-5-yl)-2-(methylamino)butan-l-one (butylone) 25 \/✓ 1-(1,3-Benzodioxo1-5-yI)-2-(methylamino)pentan-l-onel-(l13-BenzodioxoI-5-yl)-2-(methylamino)pentan-l-one (pentylone) 25 / 1-(11 -(1 -Phenylcyclohexyl)pyrrolidine-Phenylcyclohexylpyrrolidine 10 Il-(5-Fluoropentyl)-3-(l-naphthoyl)indole -(5-Fluoropentyl)-3-(1-naphthoyl)indole (AM2201) 45 v 1-(5-Fluoropentyl)-3-(2-iodobenzoyDindolel-(5-FIuoropentyl)-3-(2-iodobenzoyl)indole.(AM694) (AM694) 45 v 1-[1-(2-Thl-[l-(2-Thienyl)cyclohexyl]piperidine enyl)eyclohexyl]piperidine 15 / 1-[2-(4-MorpholinyBethy1]-3-(1-naphthoyeindolel-[2-(4-Morpholinyl)ethyl]-3-(l-naphthoyl)indole (JWH-200) 45 1-Butyl-3-0-naphthoyDindolel-Butyl-3-(l-naphthoyI)indole (JWH-073) 45 s/ l-Cyclohexylethy1-3-(2-methoxyphenylacetyl)indolel-CycIohcxylethyl-3-(2-methoxyphenylacetyl)indole (SR(SR-18-18 and RCSRCS-8)-8) 45 l-Hexy1-3-(1-naphthoyl)indolel-Hexyl-3-(l-naphthoyl)indole (JWH-019) • 45 J L 1-Methyl-4-phenyl-4-propionoxypiperidinel-Methyl-4-phenyl-4-propionoxypiperidine 2 v 5 Vol. I Page 951 1-Penty1-3-(1-naphthoyeindole1 -Pentyl-3-( 1 -naphthoyl)indole (JWH-018(J WH-0 1 8 and AM678) 45 L 1-Penty1-3-(2-chlorophenylacetypindolel-PentyI-3-(2-chlorophenylacetyl)indole (1WH-203)(JWH-203) 45 v 1-Penty1-3-(2-methoxyphenylacetypindolel-Pertfyl-3-(2-methoxyphenylacety!)indole OWH-250)(JWH-250) 45 y 1-Penty1-3-(4-chloro-1-naphthoyDindolel-Penty[-3-(4-chloro-l-naphthoyl)indo!e (JWH-398) 45 1-Penty1-3-(4-methyl-1-naphthoyl)indolel-Pentyi-3-(4-methyl-I-naphthoyl)indole (JWH-122) 45 1-Penty1-3-[(4-methoxy)-benzoyflindolel-Pentyl-3-[(4-methoxy)-benzoyl]indole (SR(SR-19,-19, RCSRCS-4)-4) 4545_y 1-Penty1-341-(4-methoxynaphthoyl)]indolel-Pentyl-3-[l-(4-methoxynaphthoyl)]indole (JWH-081)(JWH-08 1) 45 -y 2-(2,5-Dimethoxy-4-n-propylphenyl)ethanamine (2C(2C-P)-P) 30 ^ ' 2-(2,5-Dimethoxy-4-ethylphenyl)ethanamine (2C(2C-E)-E) 30 2-(2,5-Dimethoxy-4-methylphenypethanarnine2-(2,5-Dimethoxy-4-methylphenyl)ethanamine (2C(2C-D)-D) 30 ^ 2-(2,5-Dimethoxy-4-nitro-phenyl)ethanamine (2C(2C-N)-N) 30 y 2-(2,5-Dimethoxyphenypethanamine2-(2,5-DimethoxyphenyI)ethanamine (2C(2C-H)-H) 30 y 2-(4-Bromo-2,5-dimethoxypheny1)-N-(2-methoxybenzyflethanamine2-(4-Bromo-2>5-dimethoxyphenyl)-N-(2-methoxybenzyl)ethanamine 25 y (25B-NBOMe; 2C-B-NBOMe; 25B; Cimbi-36) 2-(4-Chloro-2,5-dimethoxyphenyl)ethanamine2-(4-Chloro-2,5-dimethoxyphenyl)ethanaminc (2C(2C-C)-C) 30 2-(4-Chloro-2,5-dimethoxypheny1)-N-(2-methoxybenzyflethanamine2-(4-Chloro-2,5-dimethoxyphenyl)-N-(2-methoxyben7-yl)ethanamine 25 / (25C-NBOMe; 2C-C-NBOMe; 25C; Cimbi-82) 2-(4-lodo2,5-dimethoxyphenyl)ethanamine2-(4-Iodo-2,5-dimethoxyphenyl)echanamine (2C(2C-I)-I) 30 2-(4-1odo-2,5-dimethoxypheny1)-N-(2-methoxybenzyl)ethanamine2-(4-Iodo-2,5-dimethoxyphenyl)-N-(2-methoxybenzyl)ethanamine (25I-(251- 1515 / NBOMe; 2C-I-NBOMe; 251; Cimbi-5) Lc 2-(Methylamino)-1-phenylpentan-2-(Methylamino)- 1 -phenylpentan- 11 -one (pentedrone) 1515 2,5-Dimethoxy-4-ethylamphetaminc (DOET) 25 ^ 2,5-Dimethoxy-4-n-propylthiophenethylamine 25 i/ 2,5-Dimethoxyamphetamine 25 2-[4-(Ethylthio)-2,5-dimethoxyphenyl]ethanamine (2C(2C-T-2)-T-2) 30 v 2[4-(Isopropylthio)-2,5-dimethoxyphenyliethanamine2-[4-(Isopropylthio)-2,5-dimethoxyphenyl]ethanamine (2C(2C-T-4)-T-4) 30 ^ 3,4,5-Trimethoxyamphetamine3,4,5-Tnmethoxyamphetamine 25 y 3,4-Methylenedioxyamphetamine (MDA) 55 3,4-Methylenedioxymethamphetamine3,4-Methylencdioxymethamphetamine (MDMA) 50 / 3,4-Methylenedioxy-N-cthylamphetamine (MDEA) 40 y 3,4-Methylenedioxy-N-methylcathinone (methylone) 50 3,4-Methylencdioxypyrovalerone3,4-Methylcncdioxypyrovalerone (MDPV) 35 y 3-Fluoro-N-methylcathinone (3(3-FMC)-FMC) 25 J 3-Methylfentanyl 2 y 3-Methylthiofentanyl 2 J 4-Bromo-2,5-dimethoxyamphetamine (DOB) 25 * 4-Bromo-2,5-dimethoxyphenethylamine (2(2-CB)-CB) 2525" y 4-Fluoro-N-methylcathinone (4(4-FMC)-FMC) 25 '/ iy c 4-Methoxyamphetamine 100100 \ 6 Vol. I Page 952 4-Methyl-2,5-dimethoxyamphetamine4-Methyl-2,5-dimethoxyamphetamine(DOM) (DOM) 2525]/ LC 4-Methylaminorex '• 25 4-Methyl-N-ethylcathinone (4-MEC) 25 c/ 4-Methyl-N-methylcathinone (mephedrone) 45 / 4-Methyl-a-pyrrolidinopropiophenone (4-MePPP) 25 ^ 5-(I5-(l1l-Dimethylheptyl)-2-[(lR,3S)-3-hydroxycyclohexyl]-phenol , 1-Dimethylhept yI)-2 -[(1R,35)-3-hydro xycyclohexyl ]-phenol 68 y 5-(15-(l J-Dimethylocty1)-2-KIR,38)-3-hydroxycyclohexyli-phenol, 1 -Dimethyloctyl)-2-[( 1 R,3 S)-3-hydroxycycIohexyl]-phenol 53 (cannabicyclohexanol or CP-47,497 C8-homolog) 5-Methoxy-3,4-methylenedioxyamphetamine 25 y 5-Methoxy-N,N-diisopropyltryptamine 25 5-Methoxy-N,N-dimethyltryptamine 25 v/ Acetyl-alpha-methylfentanyl 2 y Acetyldihydrocodeine 2 / Acetylmethadol 2 / Allylprodine 2 Alphacetylmethadol 2 alpha-Ethyttryptaminealpha-Ethyltryptamine .. 25 / Alphameprodine 2 i/ Alphamethadol ~22 y alpha-Methylfentanyl ~22 y c alpha-Methylthiofentanyl 2 y alpha-Methyltryptamine (AMT) 2525/ . alpha-Pyrrolidinobutiophenonealpha-PyrrolidinobuIiophenone (a-PBP) 25 alpha-Pyrrolidinopentiophenone (a-PVP)(q-PVP) 25 Aminorex 25 BenzylmorphineBertzylmorphine 2 Betacetylmethadol 2 beta-Hydroxy-3-methylfentanyl 2 V beta-Hydroxyfentanyl 2 y BetameprodineBctameprodine 2 ^ Betamethadol 4 BetaprodineBctaprodine 2 y Bufotenine 3 y Cathinone . 70 y Codeine methylbromide 5 y CodeineCodeine-N-oxide-N-oxide 305 Desomorphine 25 y DiethyluyptamineDiethyltryptamine 25 Difenoxin 11,00011,000 7 Vol. I Page 953 Dihydromorphine 3,990,000 c Dimethyltryptamine 35 Dipipanone 5 Fenethylline 5 gamma-Hydroxybutyric acid 70,250,000 v" Heroin 50 Hydromorphinol 2 Hydroxypethidine 2 Ibogaine 5 Lysergic acid diethylamide (LSD) 35 Marihuana 658,000 • Mescaline 25 Methaqualone 1010 MethcathinoneMethcathinonc 25 / Methyldesorphine 5 ^ Methyldihydromorphine 2 Morphine methylbromidemethyibromide 5 Morphine methylsulfonate '' 5 V MorphineMorphine-N-oxide-N-oxide 350 c/ N-(I-Adamantyl)-I-pentyl-1$-indazole-3-carboxamideN-(I-Adamantyl)-l-pentyMH-indazole-3-carboxamide (AKB48) 25 N-(1-Amino-3,3-dimethyl-l-oxobutan-2-y1)-1-pentyl-lH-indazole-3-N-( 1 -Amino-3 ,3 -dimethyl- 1 -oxobutan-2-yl)- 1 -pentyl- 1 H-indazole-3- 25 carboxamide (ADB-PINACA) N-(1-Amino-3-methy1-1-oxobutan-2-y1)-l-(4-fluorobenzyl)-1H-indazole- 25 N-( 1 -Amino-3 -methyl- 1 -oxobutan-2-yl)- 1 -(4-fluorobenzyl)- 1 H-indazole- X 3-carboxamide (AB-FUBINACA) N-(1-Amino-3-inethyl±oxobutan-2-y1)-1-(cyclohexylmethyl)-11N-(l-Amino-3-methyl-l-oxobutan-2-yl)-l-:(cyclohexylmethyI)-lH--1- ' 15 indazole-3-carboxamide (AB-CHMINACA) N-(1-Amino-3-methyl-l-oxobutan-2-y1)-1-pentyl-111-indazole-3-N-(l-Amino-3-methyl-l-oxobutan-2-yl)-l-pentyl-lH-indazole-3- 1515 X carboxamide (AB-PINACA) N,N-Dimethylamphetamine 25 X Naphthylpyrovalerone (naphyrone) 25 N-Benzylpiperazine 25 V N-Ethyl-l-phenyleyclohexylamineN-Ethyl- 1 -phenylcyclohcxylamine 5 N-Ethylamphetamine 24 N-Hydroxy-3,4-methylenedioxyamphetamine 24 Noracymethadol 2 Norlevorphanol 52 X Normethadone 2 Normorphine , 40 sj Para-fluorofentanyl 5 \/ 8 Vol. I Page 954 Parahexyl 5 L Phenomorphan 2 Pholcodine 5 Psilocybin 30 ^ Psilocyn 30 y* Quin°lin-8-y1Quinolin-8-yl 1-(5-fluoropenty1)-1H-indole-3-carboxylatel-(5-fluoropentyl)-lH-indole-3-carboxylate (5-fluoro-PB- 25 22;22;'5F-PB-22).5F-PB-22) . Quinolin-8-y1Quinolin-8-yl l-pentyl-II-1-indole-3-carboxylatel-pentyl-lH-indole-3-carboxylate (PB-22; QUPIC) 25 Tetrahydrocannabinols 511,250 i/' Thiofentanyl 2 Tilidine 25 Trimeperidine 2 Schedule 1111 1-Phenylcyclohexylamine1 -Phenylcyclohexylamine 5 1-Piperidinocyclohexanecarbonitrile1-Piperidinocyclohexanecarbonitrile 5 4-Anilino-N-phenethyl-4-piperidine (ANPP) 2,687,500 Alfentanil 17,75017,750 / Alphaprodine 3 / Amobarbital 25,125 / Amphetamine (for conversion) 21,875,000 L Amphetamine (for sale) 37,500,000 ^ Carfentanil 1919" / Cocaine 275,000 Codeine (for conversion) 50,000,000 Codeine (for sale) 63,900,000 Dextropropoxyphene 45 Dihydrocodeine 226,375 •V Dihydroetorphine 3 Diphenoxylate (for conversion) 75,000 DiphcnoxylateDiphenoxylate (for sale) 1,337,5001,337,500 w Ecgonine 174,375174,375 Ethylmorphine 5 V Etorphine hydrochloride 3 - Fentanyl 2,300,000 Glutethimide 3 ^ Hydrocodone (for conversion) 137,500137,500 v^"- Hydrocodone (for sale) 99,625,000 ^ Hydromorphone 7,000,000 ^ IsomethadoneIsomcthadone 5 L Levo-alphacetylmethadol (LAAM) 4 \/ 9 Vol. I Page 955 Levomethorphan 30 / L LcvorphanolLcVorphanol 7,125 / LisclexarnfetamineLisdcxamfetamine 29,750,000 Meperidine 6,250,000 ,/ Meperidine IntermediateIntermediate-A-A 6 l/" Meperidine IntermediateIntermediate-B-B 32 (/" Meperidine IntermediateIntermediate-C-C 6 Metazocine 19w ^ Methadone (for sale) 31,875,000 ^ Methadone Intermediate 34,375,000 / MethamphetaminMethamphetamine/V 2,061,375 ^ [1,250,000[1,250,000 grams ooflcvo-desoxyephedrine cvo-desOxyephedrine for use in a nonnon-controlled,-controlled, non-prescription . product; 750,000 j^rarosr s for methamphetamine mostly for conversion to a schedule III product; and 61,375 ^ramsrams for methamphetamincmethamphetamine (for sale)] . MethylphenidateMethylphenidatc 96,750,000 Morphine (for conversion) 91,250,000 Morphine (for sale) 62,500,000 v/ Nabilone 18,75018,750 / Noroxymorphone (for conversion) 17,500,00017,500,000 Noroxymorphone (for sale) 1,475,0001,475,000 c Opium (powder) 112,500112,500 / Opium (tincture) 687,500 / Oripavine 35,000,000 V Oxycodone (for conversion) 8,350,0008,350,000./ Oxycodone (for sale) 141,375,000141,375,000 Oxymorphone (for conversion) 29,000,000 ^ Oxymorphone (for sale)-sale) 7,750,000 / Pentobarbital 35,000,000 / Phenazocine 6 PhencyclidinePhencyclidirie 38 Phenmetrazine 3 4/ Phenylacetone 9,375,000 Racemethorphan 5 Racemorphan 3 RemifentanilRemifcntanil 4,200 SecoharbitalSecobarbital 215,003 Sufentanil 6,255 / Tapentadol 12,500,00012,500,000 l/ Lc Thebaine 125,000,000125,000,000 k/ 1010 Vol. I Page 956 ListList II ChemicalsChemicals EphedrineEphedrine (for(for conversion)conversion) 1,000,000 EphedrineEphedrine (for(for sale)sale) 4,000,0004,000,000 PhenylpropanolaminePhenylpropanolamine (for(for conversion)conversion) 44,800,00044,800,000 PhenylpropanolaminePhenylpropanolamine (for(for sale)sale) 8,500,0008,500,000 PseudoephedrinePseudoephedrine (for(for conversion)conversion) 7,0007,000 PseudoephcdrinePseudoephedrine (for(for sale)sale) 224,500,000224,500,000 AggregateAggregate productionproduction quotasquotas forfor allall otherother schedule II and 1111 controlledcontrolled substancessubstances includedincluded inin 2121 CFRCFR 1308.11 andand 1308.12 remainremain atat zero.zero. Dated:Dated: ChuckChuck Rosenberg,Rosenberg, ActingActing Administrator.Administrator. 1111 - Vol. I Page 957 L A:A: AX:AX: OC:OC: OD:OD: CCR:CCR: CCO:CCO: CC:CC: ODX:ODX: ODXL:ODXL: ODODW: W: ODWODWjnalyst-.analyst: ODQ:ODQ:_ ODEQODEQ. (b)(6)(b)(6) DFN:DFN: 630630-07-FederaI-07-Federal RegisterRegister c SBF-CMSBF-CM ti# ODEQ-15-841ODEQ-15-841 1212 Vol. I Page 958 -3=^ 5564255642 FederalFederal Register/Register /Vol.Vol. 60,80, No.No. 1791 79 / /Wednesday,Wednesday, SeptemberSeptember 16,18, 20152015 / /NoticesNotices JeanJean Sanneman,Sonneman, substancessubstances havehave thethe potentialpotential forfor abuseabuse establishmentestablishment andand maintenancemaintenance ofof L BureauBureau ofof LandLand Management.Management. InformationInformation andand dependencedependence andand areare controlledcontrolled toto reservereserve stocks.stocks. TheThe DEADEA diddid notnot receivereceive CollectionCollection ClearanceClearance Officer.Officer, BureauBureau ofof LandLand protectprotect thethe publicpublic healthhealth andand safety.safety. anyany commentscomments relatedrelated toto thethe proposalproposal Management.Management. SectionSection 306306 ofof thethe CSACSA (21(21 U.S.0U.S.U. notnot toto adjustadjust thethe 201.52015 assessmentassessment ofof IFR[FR Doc.Doc. 2015-232572015*23257 FtIodFilod 9-15-15;8:452ml9-15-15; 8:45 om) 826)026) requiresrequires thethe AttorneyAttorney GeneralGeneral toto annualannual needsneeds forfor ephedrine,ephedrine, BILLINGBILLING CODECODE 4310-14-P4310-W-P establishestablish aggregateaggregate productionproduction quotasquotas pseudoephedrine,pseudoephedrine, andand forfor eacheach basicbasic classclass ofof controlledcontrolled phenylpropanolamine.phenylpropanolamine. substancesubstance listedlisted inin schedulesschedules I 1andand IIII InIn accordanceaccordance withwith 2121 CFRCFR 1303.13,1303.13, pseudoephedrine, DEPARTMENTDEPARTMENT OFOF JUSTICEJUSTICE andand forfor ephedrine,ephedrine, pseudoephedrine, thethe DEADEA hashas takentaken intointo considerationconsideration andand phenylpropanolamine.phenylpropanolamine. ThisThis thethe aboveabove commentscomments alongalong withwith thethe DrugDrug EnforcementEnforcement AdministrationAdministration responsibilityresponsibility hashas beenbeen delegateddelegated toto thethe relevantrelevant 20142014 year-endyear-end inventories.inventories, AdministratorAdministrator ofof ththee DEA.DEA. 2823 CFRCFR initialinitial 20152015 manufacturingmanufacturing andand importimport (Docket(Docket No.No. DEA-418F)DEA-418F] 0.100(b).0.100(b). quotas.quotas, 20152015 exportexport requirements,requirements, actualactual and projected 2015 sales, research and FinalFinal AdjustedAdjusted AggregateAggregate Production and projected 2015 sales, research and Production BackgroundBackground product development requirements, and QuotasQuotas forfor ScheduleSchedule I Iandand IIII ControlledControlled product development requirements, and TheThe DEADEA establishedestablished thethe initialinitial 20152015 the additional quota applications SubstancesSubstances andand AssessmentAssessment ofof the additional quota applications aggregateaggregate productionproduction quotasquotas forfor received.received. UponUpon consideration of the AnnualAnnual NeedsNeeds forlor thethe ListList I IChemicalsChemicals consideration of the controlledcontrolled substancessubstances inin schedulesschedules I 1andand above, the Administrator determined Ephedrine,Ephedrine, Pseudoephedrine,Pseudoephedrine, andand above, the Administrator determined 11II andand thethe assessmentassessment ofof annualannual needsneeds thatthat thethe proposed adjusted 2015 PhenylpropanolaminePhenylpropanolamine forfor 20152015 proposed adjusted 2015 forfor thethe listlist I 1chemicalschemicals ephedrine,ephedrine, aggregateaggregate productionproduction quotasquotas forfor AGENCY:agency: DrugDrug EnforcementEnforcement pseudoephedrine,pseudoephedrine, andand dihydroetorphina,dihydroetorphins, ethylmorphine,ethylmorphine, Administration,Administration, DepartmentDepartment ofof Justice.Justice. phonylpropanolaminephenylpropanolamine onon SeptemberSeptember 8.0. etorphineetorphine HCI,HC1, recemethorphan,raceroethorphan, 53216. That notice stated ACTION:ACTION: FinalFinal order.order. 2014.2014. 7979 FRFR 53216. That notice stated racemorphan.racemorphan, methylphenidate,melhylphenidate. andand thatthat thethe DEADEA couldcould adjust,adjust, asas needed.needed, oxycochoneoxycodone (for(for sale)sale) requiredrequired additionaladditional. SUMMARY:SUMMARY: ThisThis finalfinal orderorder establishesestablishes thethe establishedestablished aggregateaggregate productionproduction considerationconsideration andand herebyhereby furtherfurther adjustsadjusts thethe finalfinal adjustedadjusted 20152015 aggregateaggregate quotasquotas andand assessmentassessment ofof annualannual needsneeds thethe proposedproposed 20152015 aggregateaggregate productionproduction productionproduction quotasquotas forfor controlledcontrolled inin accordanceaccordance withwith 2121 CFRCFR 1303.131303.13 andand quotasquotas forfor thesethese substances.substances. RegardingRegarding substancessubstances inin schedulesschedules I Iandand 11II ofof thethe 2121 CFRCFR 1315.13.1315.13. TheThe proposedproposed adjustedadjusted codeinecodeine (for(for sale),sale), fentanyl,fentanyl, gammagamma ControlledControlled SubstancesSubstances ActAct andand thethe 20152015 aggregateaggregate productionproduction quotasquotas forfor hydroxybutrichydroxybutric acid.acid, hydrocodonehydrocodone (for(for assessmentassessment ofof annualannual needsneeds forfor thethe listlist controlledcontrolled substancessubstances inin schedulesschedules landI and sale).sale), methadone,methadone, methadonemethadone Ichemicalschemicals ephedrine,ephedrine, HandII and assessmentassessment ofof annualannual needsneeds forfor intermediate,intermediate, morphinemorphine (for(for pseudoephedrine.pseudoephedrine. andand thethe listlist I Ichemicalschemicals ephedrine.ephedrine, conversion),conversion), oripavine,oripavina, oxymorphoneoxymorphone phenylpropanolamine.phenylpropanolamine. pseudoephedrine,pseudoephedrine, andand (for(for conversion),conversion), andand oxymorphoneoxymorphone (for(for phenylpropanolaminephenylpropanolamine werewere sale) the Administrator hereby . DATES:dates: ThisThis orderorder isis effectiveeffectivo SeptemberSeptember sale) the Administrator hereby subsequentlysubsequently publishedpublished inin thethe FederalFederal determinesdetermines thatthat thethe proposedproposed adjustedadjusted L 16,16, 2015.2015. RegisterRegister onon JulyJuly 8,0, 2015,2015, 8080 FRFR 39156,39156, 20152015 aggregateaggregate productionproduction quotasquotas forfor FORFOR FURTHERFURTHER INFORMATIONINFORMATION CONTACT:CONTACT: JohnJohn outlined criteria. inin considerationconsideration ofof thethe outlined criteria. thesethese substancessubstances asas publishedpublished inin thethe R.R. Scherbenske,Scherbenske, OfficeOffice ofof DiversionDiversion AllAll interestedinterested personspersons werewere InvitedInvited toto FederalFederal RegisterRegister onon JulyJuly 8,8, 2015.2015, 8080 FRFR Control,Control, DrugDrug EnforcementEnforcement commentcomment onon oror objectobject toto thethe proposedproposed 39156,39156, areare sufficientsufficient toto meetmeet thethe currentcurrent Administration.Administration. 87018701 MorrissetteMorrissette Drive,Drive, adjustedadjusted 20152015 aggregateaggregate productionproduction 20152015 estimatedestimated medical,medical, scientific.scientific, Springfield,Springfield, VirginiaVirginia 22152;22152; Telephone:Telephone: quotasquotas andand assessmentassessment ofof annualannual needsneeds research,research, andand industrialindustrial needsneeds ofof thethe (202)(202) 598-6812.598-6812. onon oror beforebefore AugustAugust 7,7, 2015.2015. UnitedUnited StatesStales andand toto provideprovide forfor SUPPLEMENTARYSUPPLEMENTARY INFORMATION:INFORMATION: adequateadequate reserve stock AnalysisAnalysis forfor FinalFinal AdjustedAdjusted 201521115 reserve stock. AsAs describeddescribed inin thethe previouslypreviously LegalLegal AuthorityAuthority AggregateAggregate ProductionProduction QuotasQuotas andand publishedpublished noticenotice establishingestablishing thethe 20152015 AssessmentAssessment ofof AnnualAnnual NeedsNeeds TheThe DrugDrug EnforcementEnforcement aggregateaggregate productionproduction quotasquotas andand has been given to the AdministrationAdministration (DEA)(DEA) implementsimplements andand ConsiderationConsideration has been given to the assessmentassessment ofof annualannual needs,needs, thethe DEADEA outlined in the 2015, enforcesenforces tidestitles IIII andand IIIIII ofof thethe criteriacriteria outlined in theJulyJuly 6.6, 2015, haslias specificallyspecifically consideredconsidered thatthat ComprehensiveComprehensive DrugDrug AbuseAbuse PreventionPrevention noticenotice ofof proposedproposed adjustedadjusted aggregateaggregate inventoryinventory allowancesallowances grantedgranted toto andand ControlControl ActAct ofof 1970.1970. asas amended.amended. 2121 productionproduction quotasquotas andand assessmentassessment ofof individualindividual manufacturersmanufacturers maymay notnot U.S.C.U.S.C. 801-971.801-971. TidesTitles IIII andand III111 areare annualannual needs,needs, 8080 FRFR 39156.39156, inin alwaysalways resultresult inin thethe availabilityavailability ofof referredreferred toto asas thethe "Controlled"Controlled accordanceaccordanco withwith 2121 CFRCFR 1303.131303.13 andand 2121 sufficientsufficient quantitiesquantities toto maintainmaintain anan SubstancesSubstances Act"Act" andand thethe "Controlled"Controlled CFRCFR 1315.13.1315.13. FiveFive companiescompanies submittedsubmitted adequateadequate reservereserve stockstock pursuantpursuant toto 2121 SubstancesSubstances ImportImport andand ExportExport Act,"Act," timelytimely commentscomments regardingregarding twelvetwelve U.S.G.U.S.C. 826(a),826(a), asas intended.intended. SeeSee 2121 CFRCFR respectively,respectively, endend areare collectivelycollectively scheduleschedule II andand IIII controlledcontrolled substances.substances. 1303.29.1303.24. ThisThis wouldwould bebe concerningconcerning ifif aa referredreferred toto asas thethe "Controlled"Controlled TheseThese commentscomments suggestedsuggested thatthat thethe naturalnatural disasterdisaster oror otherother unforeseenunforeseen SubstancesSubstances Act"Act" oror thethe "CSA""CSA" forfor thethe proposedproposed adjustedadjusted aggregateaggregate productionproduction eventevent resultedresulted inin substantialsubstantial disruptiondisruption purposespurposes ofof thisthis action.action. TheThe DEADEA quotasquotas forfor codeinecodeine (for(for sale).sale), fentanyl,ientanyi, toto thethe amountamount ofof controlledcontrolled substancessubstances publishespublishes thethe implementingimplementing regulationsregulations gammagamma hydroxybutrichydroxybutric acid.acid, availableavailable toto provideprovide forfor legitimatelegitimate forfor thesethese statutesstatutes inin titletitle 2121 ofof thethe CodeCode hydrocodonehydrocodone (for(for sale),sale), methadone,methadone, publicpublic need.need. AsAs such,such, thethe DEADEA includedincluded ofof FederalFederal RegulationsRegulations (CFR),(CFR], chapterchapter II.II. methadonemethadone intermediate.intermediate, inin allall scheduleschedule IIII aggregateaggregate productionproduction TheThe CSACSA andand itsits implementingimplementing methylphenidate,mathylphenidate, morphinemorphine (for(for quotas,quotas, andand certaincertain scheduleschedule II aggregateaggregate regulationsregulations areare designeddesigned toto prevent.prevent, conversion),conversion), oripavine,oripavine, oxycodoneoxycodone (for(for production quotas,quotas, anan additionaladditional 25%25% ofof detect,detect, andand eliminateeliminate thethe diversiondiversion ofof sale).sale), oxymorphoneoxymorphone (for(for conversion).conversion), thethe estimatedestimated medical,medical, scientific,scientific, andand controlledcontrolled substancessubstances andand listedlisted andand oxymorphoneoxymorphone (for(for sale)sale) werewere researchresearch needs asas part ofof thethe amountamount chemicalschemicals intointo thethe illicitillicit marketmarket whilewhile insufficientinsufficient toto provideprovide forfor thethe estimatedestimated necessarynecessary toto ensureensure thethe establishmentestablishment providingproviding forfor thethe legitimatelegitimate medical,medical, medical,medical, scientific,scientific, research,research, endend andand maintenancemaintenance ofof reservereserve stocks.stocks. TheThe L scientific,' ti reresearch, arch andel •industrial cl t i t needsd industriald t • .I needsd offththe UUnited 't dStStales, i ffor Ffinal I establishedtbl'hdggaggregate gt pproduction d t' ofof thethe UnitedUnited States.States. ControlledControlled exportexport requirements.requirements, andand forfor thethe quotasquotas willwill reflectreflect thesethese includedincluded Vol. I Page 959959 < a re §• l c- 5 S tji i ? £ 1791 Wednesday, 5 SeptemberI5 | 16, 2015/Notices 55643 Federal Register/Vol.f BD, No. S 3 2 I g amounts. This action will not affect the * disruption to the amount of controlled aggregate production quotas forjhe p.g P. — ® S\£ abilityli of manufacturers to maintain substances available to provide for following schedule I and II controlled r Ol C s — g II l§t a. g 111 Ml inventory5'g-s allowances as specified by legitimate public need, as determined substances and the 2015 assessment of g re«cA^ 2 PS i rogulation.3 The DEA expects that by the DEA. The DEA does not annual needs for the list ['chemicals CL— 3">l?r i I • II S"sr2g.g — maintaining3 this reserve in certain anticipate utilizing the reserve in the ephedrine, - pseudoephedrine, and s 8-§JfS2: ^-oo o <= 8 established aggregate production quotas absence of these circumstances. phenylpropanolamine,"E-S expressed in 3»i5 f}.s.§s^§.g- gagg-SVg1 2.-a O-rt s-8-srPs? assail^ Sa^S-ls1- u q- I ,5ts"-s will mitigate adverse public effects if an Pursuant to the above, the grams of anhydrous^l^S-SS-S acid or base, as HI ^fl"§P'! tr c- —7Sa®<->-c>c I'g-i i'Sasflg & O to o"3 §S !££§•? 8lil£i?l ifSHiih moa)00-^ llHIIli Ii?l>Ht rsiSlaii s-fls-a-s^a la,aS£8Js- ||r > IIIPlp illlllsf oJ^CjCjo £-ir!f|i&r unforeseen event results in substantial Administrator hereby finalizes^ the 2015 follows: Final adjusted— K 2 SI 22 cn Basicg" s class 2015 quotas (0) Schedule!E i 1 (1-Penryl-1H.indol3ryl)(2,2,3,3Aetramethylcyclaprept4)methanOne? (1.1R-144) 25 x; d (1.(5-Fluoro-penty1)-1H-indol-3-y11(2,2,3.3-talramethylcyclopropyqmethanone (XLR11)w 25 i3« i 111 15 11-(5.tuo(Openty1)-1H-Indazol-3-ylEnaphthalen-1-yqmethanone (THJ-2201) ~§1 ' 1-(1,3-Benzodioxol-5.1/0-2.(melhylarrine)bulan-1-one (butylono)O 25 ilfji O 3 mil 25 1-(1.3-Beneodioxel-5.0)2-(methylambo)pentan-1.onellil Iltll (pentylone)fl||! •g§i|l 1-(1-Phenylcyclohexyl)pymnIldlne ? ! 10 1-(5-Flueropenty1)-3-(1-naphlboylbndole (AM2201) i 45 If! I "»!£&»* llpl 45 1-(5-Fluorapenty1)-3-(2-iodobenaoynindole (AM694)Hi fr; 1.11-(2-Thlenyl)cydehexyl)pipe ridine}i| 15 l| 45 II 1-12-(4-Morpholinyl)ethy11-3-(1-naphthoyl)Indole I! (JWH-200) "4 45 1-Butyl-3-(1-naphthoyljindele (JW11-073)M i 0> & 45 Ill |j 1-Cyclohexylethyl-3.(2-melhoxyphenylacelyqindole1! (SR-113 and RCS-8) : Ul I-Hoxyb3-(1-naphthoy0lndole (JWH-019) 1 45 1-Maihyl-4.phenyl-4.propionoxypiperidine I 2 i 1-Penly1-3-(1-naphlhoyllindolegXl (JWH-016 and AM678) 45 S 1-Penly1-3-(2-chlorophenylacetyqindole§ (JWH-203) 45 I 1-Penly1-3-(2-metboxyphenylacelyI)indole? (JWH-250)IpltfMi 45 1-Perayba-(4-cblaro-l-napbtboygindole§ (JWH-395) 45 1-Penly1-3-(4-methyl-1-naphtheynindole (JWH-122) 45 45 ?^ 1-Penty1.34(4.melhoxy)-benzoyFindole (611-19. RCS-4) rM l 45 1-Penly1-3-11-(4-melhoxynaptehoynlIndoleI (JWH-081) f i 2-(2,5-Dimelboxy-4-n-propylpheny)ethanamine§r£Tf~F^if (2C-P) 30 2-(2,5.01me1boxy-4-elhylphenynalhanaminef (2C-E) 30 r M 2-(2,5-Dimelhoxy-4-melhylphenyl)elhanamlnef (2C-D) no 2.(2,5-Dimelhoxy.4.nitro-phenyl)ethanamineIII!! (2C-N) 30 2.(2.5:Dimethoxyphenyl)ethanaminel§4§ IllillltiiiHif (20-H) 30 z g 1 | M cn ? S § * ® P 25 & 2.(4.Bromo-2,5.dimethoxypheny1)-N-(2-methoxybenzylbelhanammeIN (258-NBOMe; 2C-B-NBOMe: 25B; Cim01-36) : : i 2.(4.Chloro-2.5-dimethoxyphenyl)elhanamine1'3'^f If (2C-C) 30 *-i es; |1 N: y\ ?! 2.(4-Chloro-2,5-dimelhoxypheny1).N.(2-melhoxybenzyl)ethanaminoI! Si to I! O (25C-NBOMe; 2C-C-NBOMe; 25C;P! Cen1q1-62)Sis 25 : i 30 2.(4.1odo-2,5-dirnethozyphenyhethanamine*1* (2C-1) |! 2 i!?i? 2i fO cn 2. *< li Si si 2: -T ?! 15 §£§' 2-(4.1odo-2.5.thmethoxyphenyb-N1-(2-melhoxybenzyl)elhanamine (25HNBOMe;-M 20-I-NBOMe; 251; Cimbi-5) i 15 Hill! 2.(Melbylamlno)-1-phenylf≥enten-1-une (pentedrone)i|rp|| 25 2.5-Dimelhoxy-4-elbylampholarninei-6 (DOET) ffl!fl|!ifpl!sll!ll! 25 2,5-Dimethoxy-4-n-propylthiophenelhYlemineII tip! 25 2,5-DImelhoxyamphetemine illtllllltllfllllilltl! 30 244-(EthylthiO)-2,5-dimelhoxyphenyllelhanarmneJ (20-T-2) =- as i in 30 I fol< 2.(4-(lsopropyllhio)-2,541imelhoxyphenyqethanamineill (2C-T-4) I 25 3.4,5-Trimethoxyamphelaminei-^A^ 3.4-Methylenedioxyamphemmlne (MDA) 55 50 34-Meihylenedioxymethamphelamlne24 (M DMA) 3,4-Melhylenedi0xy-N-ethylamphetamine (MDEA) 40 - 50 w< IPI 3.4-Methylenedioxy-N-methylcathlnone1-? (methylene) 3.4-Melhylenedioxypyrovalerune (MDPV) i 35 i 25 rtllll! Sllplri!! tnm 3-Fluoro.N.methyteathInone1-5 (3-FMC) . ! ! 2 3-Methyllenlanyl I 3-Mathyllhlolentanyl 2 4.Bromo-2,5-dlmethoxyampbelamlne (DOB) 25 111! © 25 4-Bromo-2,5-dImethoxyphenethYlamlne ( 2-CE1) 25 ff Hll I|I! 4-Fluom-N-methylcathIncne (4-FMC) fill 4-Methoxyamphetamine 100 1! 25 !! 4-Methyl-2.5-dimethoxyamphatamIne1: (DOM) 25 4-Mainylamlnoreq 1 4-Mathyl-N-Mtlylcallenene (4-MEG) 25 4-metnyl-Nmethylcatninone (mephedrona) 45 4-Methyba-pyrrolldlqopropiophenone (4-MePPP)%ri 25 5-(1.1.1)Imethylhepty1)-24(1R,35).3.hydroxycyclohexylj-phenolo 68 I 3 o £ g o £ «o 2 3?? — 2 llf s 53 5 II if! -47,497 CZeomolog) ..... 5-(1,1421methylocly1)-2-[(1F135)-3-bydroxycyclohexyllUH -phenol (cannableyelohexanol or GP 5-Melhoxy-3,4-Methylenedioxyamenetamine 25 5-Metboxy-N,N-diisopmpy0ryptamine^sifssSrii Will) 25 H 25 r 5-Melhoxy-N,N-eimethyltryptamine 2 ?ii^!l^i4lV|3VV'Ji3§iniMi888!i i ^3 Acetybalphametnyttentanyl|llliilllplkmiffffl|l€l||f|||||iijff||?5$5=s5p§^|||§lici il!l|lls|! "0 0) CD CD CO O Vol. I PageCO 960 55644 Federal Register/Vol. 80, No. 17979 /Wednesday, September 16, 2012015/Notices /NeticeS Final adjusted Basic class 2015 quotas L (g)(9) 2 ACetyldihydrocodeineAcetyldihydrocodeine 2 2 AcetylmethadolAcatylmeihadol 2 2 AlfylprodineAllylprodine 2 2 AlphaceiylmethadolAlphacelylmelhadol alpha-Elhyltryptaminealpha-EIhyltryptamine 25 2 Alphameprodine 2 2 Alphamethadol 2 2 alpha.Methyllentanylalpha-Methyilentanyt 2 2 alpha-Methylthiotentanylatpha-Methylthiofentanyl 2 alpha-Methyluyptaminealpha-Methyltryptamine (AMT)(AWT) 25 25 alpha-Pyrrolldinobutlophenonealpha-Pyfolldinobullopfienone (a-PBP)(a-PBP) 25 25 alpha-PyrrolldlnoPentioptenonealpha-Pyrrolldlnopentiophenone (a-PVP)(a-PVP) 25 25 AminorexArrinorex 2 BenzylmorphineSenzyimorphine - ; 2 BetacetylmethadolBctaeetyimethsdol — 2 beta.Hydroxy-3-melnyllentanylbeta-Kydfoxy-3-methyllentanyl • 2 beta-Hydroxylentanylbeta-Hydroxyfcntanyl 2 Betameprodine 4 BetamethadolBetarr.ethadol 2 &tap/termBetaprodmo - 3 BufolenineBufetenine 70 Cathinone 5 Codeine methylbromide 305 CodeineCodeine-N-oxide-NI-oxide 25 DesornorphineDesomwphine 25 DiethyltrypiamlneDiethylirypiamlne 11.00011,000 DifenoxinDi/sneotin 3,990,000 Dihydromorphlne n 35 DimethyltryptamineDimethyltryplamine 35 5 Dipipanone 5 Fenethylline 70,250,000 gamma-Hydroxyloutyricgamrria-Hydroxybutyric acid 50 Heroin 2 HydromorphinolHyflromorphirol 2 L HydroxypethidineHydroxypettiidine 5 lbogaineIbogalne 35 Lysergic acid diethylamide (LSD)(LSD) 658.000658,000 Marihuana 25 Mescaline — 10 Methaqualone 25 MethcalninoneMethcalhinor.e 5 Methyldesorphine 2 MethyldihydrornerPhineMethyldihydromorphine 5 Morphine methylbromide 5 Morphine methylsullonatemethylsulfonate 350 MorphineMorphine-N-oxide-N-oxide 25 N-(1-Adamanly1).1.penty1-1H-Indazole-3-oarboxamideN-(i-Adamantyl)-1-pentyl-1H-indazoie-3-carBoxamide (AKB46)(AKB48) 25 14-(1-Arano-3,3-dimethyl-l-oxebtitan-211)-1-Penty1-1H-indazoleN-(1-Arr.lno-3,3'dirr!ethyl-1-oxcbutan-2-yl)-1-pentyl-1H-irida2o!e-3-carboxamkJe-3-carboxamide (ADB-PINACA)(ADB-PINACA) N.(1-Arrino-3-methyl-1-oxobutan-211)-1-(4-11uorobenz14)-1H-Indazole-3-carboxamideN.(i-Arrino-3-methyl-1-oxobutan-2-yl)-1-(4-lluorobenzyl)-1H-indazole-3-carboxamide (AB-FUEll(AB-FUBINACA) MAGA) 25 51-(1-Arnino-3-methy1-1-oxobutan-211)1-(cyclohexylmothyl)-1H-IneazoleN-(1-Airino-3-methy1-1-oxobjtan-2-yl)-1-(cyclohexylmothy])-1H-indazole-3-carboxamide-3-carboxamide (AB-CHMIMACA)(AB-CHMINACA) 1515 1515 N-(1-Amino-3.methyl-1.oxobutan-211)-1-Penty1-1HN-(l-Amino-3-methyl-1-oxobutan-2-yl)-1-pentyl-1H-indazole-3-carboxamide-Indazole-3-CarboxamIde (AB-PINACA)(AB-PINACA) 25 N,N.OimethylamphelamineN.N-Qimelhylamphelamina : 25 NaphthyipyrovaleroneNaphthylpyrovalerone (naphyrone) ... ...... 25 N-Benzylpiperazine 5 N-Ethyl-1.-phenylcyclohexylaminoN-Ethyl-1-phenylcyclohexyiamino •'•••• 24 N-EthylamphetarnineN-Ethylamphetamine 24 N-HydN-Hydroxy-3,4-methyleneflioxyamphetamine rOXy-3,4-methylenedroxyamphetamine 2 Noracymelhadol 52 NorlevoNorlevorphanot rpha nol 2 NormethadoneNormeihadone 40 NormorphineNormorphinc 5 Para-fluorolentanyl 5 Parahexyl 2 Phenomorphan 5 Pholcodine 30 PsilocybinPsiloeybin 30 Psilocyn 25 Quinaln.8.y11-(5-fluoropenty151H-Indole.3.carboxylateQuinoiln-8-yl 1-(5-fluoroperityl)-t H-indola-3-carDoxylate (5-flunro-PB-22;(5-fluoro-PB-22; 5F-PB-22) 25 c' ave. Cuinolln-15111-penty1-1H-Indole-3-carboxylateQuinolin-8-yl 1-pentyl-1H-lrdo1e-3-carboxytale (PB-22;(PB-22; QUPIC) 511,250 TotrahydrocannablnelsTetrahydrocannabinols 2 TMThlofentanyl t 1 nyl ... 25 Tilicline Vol. I PagePage 961 Federal Register/Vol.Register/ Vol. BO, No. 179/Wednesday.79/Wednesday, September 16.16, 202015/Notices 15/Notices 55645 Final adjusted Basic class 2015 quotas (g)(9) Trimeperidine ' 2 Schedule IIII 11-Phenylcyclohexylamirte-Phenylcyclohexylamine 5 1-Piperid1-Piperiqlnocyclohexanecarbonltrile Inocyclohennecarbonitrile 5 4-Aniline-N-phenelhy1-4-plperidine4-Anilino-N-phenelhyl-4-plperidine (MVP)(AMPP) 2,687,5002,637,500 AlfentandAlferttanil 17,750 Alphaprodine 3 AmoberbealAmobaitiltal 25,125 Amphetamine (for(for conversion) 21,87521,375,050 000 Amphetamine (for(for sale) 37.500,00037,500,000 CarlentanilCarfentanil 19 Cocaine . 275.000275,000 Codeine (for(for conversion) 50,000,000 Codeine (forfor sale) 63,900,000 LlextropropoxypheneDcxtropropoxyphene 45 ElihydrocodeineDihydrocodeine 226,375 DihydroetorphineOihydroetorphine ' 3 EliphenoxylateDiphenoxylate (for(forcenversion) conversion) ]5,00075,000 CiphenoxylateDiphenoxylate (for(for sale) 1,337,500 174,375 Ecgonine 5S Ethylmorphine Elorphine hydrochloride 3 2,300.0002,300,000 Fentanyl 3 GlutethirnIdeGlutethimlde . Hydrocodone (ter(lor conversion) 137,500 99.625.000 HydrovodonoHydrocodorto dor(lor sale) . 99.625.000 7,000,000 Hydromorphone 7.000.000 5 IsomethadoneIsomethadone ; Levo-alphacetylmethadolLevo-alphacetylmeihadol (LAAM)(LAAM) 4 30 Levomelhorphan 30 7,125 LevorphanolLevorphanal 29,750,00029.750,000 LisdexamfetammeLisdexamfetamine 6,250,000 L Meperidine 6 Meperidine IntermediateIntermediate-A-A 32 Meperidine Intermediatelntecmediate-B-13 6 Meperidine IntermediateInterrr.edlate-C C 19 Metazocine 31,875,000 Methadone (for(for sale) 34,375.00034,375,000 Methadone IntermediateIntermediate 2,061,375 MethamphetamlneMethamphetamine [1,250,000[1,250,000 grams of leve-desonephedrInelevo-desoxyephedrlne for(or use InIn a nonnon-controllcd,-controlled, non-prescriptionnon-prescrlptlon product; 750,000 grams for methamphelamlnemethamphelamine mostly for conversion to a schedule IIIIII product; and 61,375 grams for methamphetamlnemethamphetamine (for(for sale)sale)] Methylphenidate 95,750,00096,750.000 91,250.000250,000 Morphine (for(for conversion) 91 62,500,00062,500.000 Morphine (for(for sale) 18,750 Nabilone 17,500,000 Noroxymorphone (for(for conversion) 1,475.0001,475,000 Noroxymorphone (for(for sale) 112,500 Opium (powder)(powder) 687,500 Opium (tincture)(tincture) 35,000,000 OripaeineOripavine 8,350,000 OxycodonoOxycodone (for(for conversion) 141,375,000 Oxycodone (for(for sale) 29.000.000 OgroorphoneOxymorphone (for(for conversion) .... 29,000,000 7,750,000 OxymorphoneOxymorphonc (for(for sale) 35,000,000 Pentobarbital 6 PhenazocinePhenazocinc 38 Phencyclidine 3 Phenmetrazine 9,375,0009,375.000 Phenylacetone 5 HacernethorphanBacemelhorphan 3 PacemorphanBacemo/phan 4,200 HemifentanilBemifentanll 215,003 SeenbarbilalSecobarbital v 6,255 SuleniannSufentanil 12,500,000 TapontadolTapentadol 125,000,000 L ThThebalne b I Vol. I PagePage 962 55646 Federal Register/Vol.Register/ Vol. 80, No. 179179/Wednesday, /Wednesday, September 16,16, 20152015/Notices /Notices HealFinal adjusted Basic class 2015 quotas (9) List I ChemicalsChomlcals EphedrineEphedrire ((or(tor conversion) 1,000,000t.OCO.OOO Ephedrine (tor(lor sale) 4,000,000 PhenytpropanolaminePhenylpropanolamine (for conversion) 44,800,000 Phenylpropanolamine (for sale) 6,500,000 PsoudoophodrinePscudoephodrino (for conversion) 7,0007.000 PseudoephedrinePseirdosphedrine (for(far sale) 224,500.000 Aggregate production quotas for all before such rate is to take effect. SecSee 79 engaging in noticenotico-and-comment-and-comment other schedule I and II controlled FR 9851. ndemaking,rulemaking, the Department published a substances included in 212 1 CFR 1308.111308.11 Pursuant to Executive Order 1365813658 Final Rule on October 7. 2014 to and 1308,121308,12 remain at zero. ' endand its implementing regulations at 29 implement the Executive Order. See 79 CFR part 10, notice is hereby given that FR 60634. The final regulations, set Dated: September 10,10, 2015. CFR part 10, notice is hereby given that FR 60634. The final regulations, set beginning January I,1, 2016, the forth at 29 CFR part 10,10. established Chuck Rosenberg, Executive Order minimum wage rate standards and procedures for Acting Administrator. that generally must be paid to workers implementing and enforcing the (FR(PR Dan.Doc. 2015-23199 Filed 9-15-15: 0:956:45 amlami performing work on or in connectinnconnection minimum wage protections of the atuNoBILLING cooaCOOS 4413-09-e441S-OT-A with covered contracts is 210.15510.15 per Order. hour. Notice is also hereby given that,that. The Executive.OrderExecutive.Order and its beginning January I,1, 2016, the required implementing regulations require the DEPARTMENT OF LABOR minimum cash wage that generally must Secretary to determine the applicable be paid to tipped employees performing minimum wage rale to be paid to Secretary Office of the Secretary work on or in connection with covered workers performing work on or in contracts is 55. 65 per hour. connection with covered contracts on an Establishing a Minimum Wage for contracts is $5,85 per hour. annual basis.basis, beginning January 1,l, 2016. Contractors, Notice atof Rate Change Inin DATES: This notice is effective on See 79 FR 9851; 29 CFR 10.1(a)(2),10.1(a)(2), Effect as of January 1, 2016 September 16,16, 2015. 10.5(a)(2),10.5(a)(2), 10.12(a).10.12(a). Sections 2(a) and (b)(b] FOR FURTHER INFORMATIONINFORMATION CONTACT: AGENCY;AGENCY: Wage and Hour Division, of the Order establish the methodology Robert Waterman, Acting Director, that the Secretary must use to determine Department of Labor. Division of Regulations, Legislation, and the annual inflationinflation-based-based increases to c ACTION: Notice. Interpretation,interpretation, Wage and Hour ➢ivision,Division, the minimum wage rate. See 79 FR U.S. Department of Labor. Room S--S- sUMMARY:SUMMARY: The Wage and Hour Division 9851. These provisions, which are 3502, 200 Constitution Avenue NW., (Will])(WHD) of the U.S. Department of Labor implemented in 29 CFR 10,5(b).10.5(b), explain Washington, DC 20210; telephone: (202) (the Department) is issuing this notice to that the applicable minimum wage 693-0406 (this is not a tolltoll-hee-free announce the applicable Minimumtninimum determined by the Secretary for each number). Copies of this notice may be wage rate to be paid to workers calendar year shall be: alternative formats (Large performing work on or in connection obtained in alternative formats (Large (i) Not less ththanan the amount in effect with Federal contracts covered by Print, Braille, Audio Tape, or Disc), on the date of such determination; Executive Order 13658,13658, beginning upon request, by calling (202) 693-0023 (ii) Increased from such amount by January 1.1, 2016. (not a tolltoll-free-free number). TTY/TTOTTY/TTD the annual percentage increase in the Executive Order 13658,13658, Establishing a callers may dial tolltoll-free-free (877) 889-5627 Consumer Price indexIndex for Urban Wage Minimum Wage for Contractors (the to obtain information or request Earners and Clerical Workers (CPI(CPI-WJ—W) Executive Order or the Order), was materials in alternative formats. (United States city average, all items, signed by President Barack Ohama on SUPPLEMENTARY INFORMATION:INFORMATION: not seasonally adjusted).adjusted), or its successor February 12.12. 2014, and raised the hourly publication, as determined by the L Executive Order 1365813658 Background minimum wage paid by contractors to Bureau of Labor Statistics (BLS):(BLS); and and Requirements for Determining workers performing work on covered (iii) Rounded to the nearest multiple Annual Increases to the Minimum Federal contracts to: $10.10 per hour, of $0.05. Wage Rate beginningJanuary January 1,1, 2015; and Section 2(b) of the Executive Order beginning January 1.1. 2016, and annually Executive Order 1385813658 was signed by further provides that, in calculating the thereafter, an amount determined by the President`BarackPresidenfBarack Ohama on February annual percentage increase in the CPI Secretary of Labor (the Secretary) in 12.12, 2014, and raised the hourly for purposes of determining the new accordance with the methodology set minimum wage paid by contractorscontracfors to minimum wage rate, the Secretary shall forth in the Order.Order, See 79 FR 9851. The workers performing work on or in compare such CPI for the most recent Secretary's determination ofoftho the connection with covered Federal month, quarter, or year available (as Executive Order minimum wage rate contracts to 510.10 per hour, beginning selected by the Secretary prior to the also affects the minimum hourly cash January 1.1, 2015; and beginning January fifirstrst year for which a minimum wage is wage that must be paid to tipped 1,1 , 2016. and annually thereafter, anon in effect) with the CPI for the same employees performing work on or in amount determined by the Secretary month in the preceding year.year, the same connection with covered contracts pursuant to the Order. See 79 FR 9651.9851. quarter in the preceding year, or the beginning January 1,1, 2016. See 79 FR The Executive Order directed the preceding year, respectively. See 7079 FR 9851-52. The Secretary is required to Secretary to issue regulations to 9851. In order to calculate the annual pprovide 'd noticeti to the public of the new Implementimplement the Order's requirements. percentage increase inIn the CPI, the L Department elected in its Final Rule minimum wage rate at least 90 days See 79 FR 9852. Accordingly, after Department elected in its Vol. I Page 963 ri 3 « 9 s- s, s= | - o. * -> * -S