2012 Established Aggregate Production Quotas
• Section 306(a) of the Controlled Substances Act (CSA) requires the Attorney General to establish limits on the production of schedules I and II controlled substances. This responsibility has since been delegated to the Administrator of the Drug Enforcement Administration (DEA).
• The regulations require that DEA revise the aggregate production quota (APQ) annually after review of pertinent information provided from various sources including DEA-registered manufacturers and the Food and Drug Administration (FDA).
• The attached Federal Register seeks to establish the APQ for 2012. A table summarizing the APQ and the changes made to the proposed established value are attached for reference.
• OD is recommending an increase in the APQ for alfentanil. This increase is based on increased exportation requirements.
• OD is recommending an increase in the APQ for dihydrocodeine. This increase is based on increased manufacturing requirements.
• OD is recommending an increase in the APQ for diphenoxylate. This increase is based on increased sales.
• OD is recommending an increase in the APQ for bydromorphinol. This increase is based on the increased need for reference standards.
• OD is recommending an increase in the APQ for lisdexamfetamine. This increase is based on increased exportation requirements.
• OD is recommending an increase in the APQ for meperidine. The increase is due to increased sales.
• OD is recommending an increase in the APQ for meperidine intermediate A. This increase is based on the increased need for reference standards.
• OD is recommending an increase in the APQ for meperidine intermediate B. This increase is based on the increased need for reference standards.
• OD is recommending an increase in the APQ for meperidine intermediate C. This increase is based on the increased need for reference standards.
• OD is recommending an increase in the APQ for morphine-N-oxide. This increase is based on the increased need for reference standards.
• OD is recommending an increase in the APQ for nabilone. The increase is to support product development efforts.
DEA/OD/ODQ
Vol. I Page 433 • OD is recommending an increase in the APQ for pentobarbital. The increase is due to increased sales and because'(f)(4) ]now properly assesses their quota at the initial manufacturing stage vs. the final finished product. The majority ofthis increase is accounting for their manufacturing losses.
• OD is recommending an increase in the APQ for properidine. This increase is based on the increased need for reference standards.
• OD is recommending an increase in the APQ for tapentadol. This increase is to support product development efforts. Currently Tapentadol ether is manufactured outside the US, the product development efforts will allow a shift to domestic manufacturing.
DEA/OD/ODQ
Vol. I Page 434 Aggregate Production Quotas (all values are In grams unless Indicated otherwise)
Controlled Substance Final Revised initial Final Revised Proposed Initial Initial N.N-Oimethylamphetamine 2 2 "2 2 2 N-EihylaVphetamirie I : 2 2 2 2 N-Hydroxy-3.4-Methylenedioxyamphetamine i- 2 2 2 2 2012 Schedule!;.. 2010 2011 2011 2012"" Noracymethadol 2 2 2 2 2 NorJcyorphanoJ__ _. 52 _« 52 52 52 Normethadone • 2 2 2 2. 2 Normorphine . 16 18 18 18 13 Para-fluorofenlanyl 2 2 2 2 2 Phenomorphan 2 2 2 2 2 Phojcodine 2 2 2 2 2 - j Psilocybin 2 2 2 2 Psiiocyn . 2 2 2 2 2 Tetrahydrocannabinols 264.000 393,000 393,000 393,000 393,000 Thiofentanyl . 2 2 2 2 2 Tilidine "" *" " 10 10 10 10 '10 Trimeperidine 2 2 2 2 2 Controlled Substance Final Revised Initial Final Revised Proposed Initial Initial
Schedule II: 2010 2011 2011 2012 2012 1-Phenyfcyclohexylamine 2 2 2 2 2 l-Piperdinocyclohexanecarbonitrile 0 1 2 2 4-Anilino-N-phenethyl-4-piperidine (ANPP) 1.100,000 2,500,000 1 .800,0001 1.800,000 1,800,000 Alfentanil 8,000 6,000 12,800; 11,600 15,000 Aiphaprodine _ 2 2 2 2 2 Amobarbjtal 3 40,007 40.007! 40,007 40,007 Amphetamine (for conversion) 7,500,000 7,500,000 8,500,000 8,500,000 8.500,000 Amphalamine (for sale) 18,600,000 18.600,000 26,300,000 25,300,000 _ 25,300.000 CarfenTanil 200 0 0 0 0 Cocaine : 247,000 247,000 __.216JOO 216,000 216,000 Codeine (for conversion) I 65,000,000 V5.b6b.000 65,000,000 65,000,000 65,000,000 Codeine (for salel . " 39,605.000" 39,605,000 39,605,000 39,60S,000 39,605,000 Oextropropoxyphene 92,000,000 92,000,000 7 7 7 Dihydrccodeine _ 800,000 800,000 _ 255,000 _255.000 400,000 Diphenoxylate ' ' 827,000 827,000 " 730,000 foo'obo ' 900,000 Ecgonjne 83,000 83,000 83,000 63,000 83,000 Ethylmorphine 2 2 . 2 2 2 Fenlanyl 1,423,000 1,428,000 1,426,000 1,426,000 1 ,423000 GlJtethimide . IJ2_ 2l"_" 2 2,~_ 2= Hydrocodone (for sale) 55.QOO.OOV 55,000,000! 59,000,000 "59,000,000 59,000,000 Hydromorphone 3.455,000: • 3,455.OOOl ~ 3,455.000 3,455,000 3,455,000 isomethadone 11 jT~ 2 4 A Levo-alphacetylmethadol (LAAM) 3 3 3 3 Levomethorphan 5 2 2 2 Levorphanol 10,000 10,000 3,600 3,600 3,600 Lisdexamfetamine 9,000.000 9,000,000 10,400,000 10,400,000 12,000,000 Meperidine ... 6,600,000 6,600,000 5,500,000 5,200,000 _5. 500, 000 M e p e ridine Intermediate-A 3 3 3 3 5 Meperidine Intermediale-B 7 7 7 7 9 Meperidine Intermediate-C 3 3 3 3 5 Melazocine 5 5 5 5 Methadone (for sale) 20,600.0001 20,000,000 20,000,000 20,000,000 20.000,000 Methadone Intermediate 26.000.0001 26,000,000 26,000,000 " 26.000,000 26,000,000 Methampheiamine 3,130,0001" ""3,130.000 3,130,000 3,130,000 3,130,000 _ levo-desoxvephedrine 7S0.000 750,000 750,000 " 750,000 750,000 meth amphelam ire (for convers ion! 2,331,000 2,331,000 2.331,000 2,331,000 2,331,000 _ methamphetamine (for sale) 49,0001 49,000 ' 49,000 49,000 49,000 Melhylphenidale 50,000,0001 50,000,000 56,000,000 56,000,000 56,000,000 Morphine (for conversion) 63.OOQ.OOOI ~ 83.000.000 70,000,000 83^000,000 83,000,000 Morphine (for sale) 39,000,000 39,000,000 39,000,000 39.000.000 39,000,000, Nabilono 9.002 10,502 10,5021 10,502 20,5021 Noroxymqrphonejfor conversion) 9.000.0001 9,000,000 7,200,0001 7,200,000 7,200,000 Koroxymorphone (for sale) 41,000 401,0001 401,000 401,000 401,000 Opium (powdered) 230,000. 230,000 _ 63,000 _ 63,000 63,000 Opium (tincture) " i?5QQ,dbo "1 .500.000 1,000,000 1,000,000 1,000,000
Page 2
Vol. I Page 435 Aggregate Production Quotas (all values are in grams unless indicated otherwise)
Controlled Substance Final Revised Initial Final Revised Proposed Initial Initial Oripayijie _ 15,000,000 15,000,000 5,000,000 6,000,000 9,600, 000 Oxycodone (for conversion) . 5.600,000 " " "5.600,000 ^57600,000 5,606,000 "5,600.000 Oxy'codone'(forsate) 105,500,000 105,500,000 96.000,000 96,000,000" 9,800,000 Schedule II: . "" 2010 ' 201 f 2011 2012 2012 Oxymorphoneffor conversion) 12,800,000 _ 12,800,000 12,800,000 12.80070D01 12,800,000 Oxymorphone (for sale) ... "" 3.070,000 ' 3,070,000' 3.070,000 "" 5,500,000? " 3,070,000 Pentobarbital . . 28.660,006 _ 28,660,000 34,000^000 31 ,000,0001 34,000.000 Phenazccine 1 5 _5i 5 5 Phencydidine . 24 24 24 24 Phenme!»02ina 2 2 2 2 2 Phenyiacetone7_ „ 12,500,001 8,000.000 e.ooo,oool 8,000,000 16,000*,"000 Pr?perid^ie 2 Racemethorphan 2 2 2 " 2 2 Remifentanil 2,500 2,500 2,500 2,500" 2,500 Secobarbital "67,000 260,002 336,002 336,002 336,002 Sufentanil 7,OOql _ _71000| 5,000 _ 5,000 5,000 Tapentadol ' 1600",oo'o" *" 1.000,006 403.000 l'_ 243,000 " 5.406606 thebaine 126,000,OOOl "126.000,000 116,666,000 116",O'OO.OOO 11,600,000
PageS
Vol. I Page 436 Dr"g Proposed APQ Establish APQ Change 3,4-Methylenedioxy-N-melhylcathinone (melhylone) 8.0 8.0 3,4-Methylenedioxypyrovalerone (MDPV) 8.0 8.0 4-Meihyl-N-methylcathinone (mephedrone) 8.0 8.0 11,600.0 IS.000.0 3,400.0 alfentanil i dihydrocodeine 255,000.0 400,000.0 145,000.0 500.000.0 900,000.0 400,000.0 diphenoxylate i gamma hydroxybutyric acid 29,000,000.0 47,000,000.0 18,000,000.0 hydromorphinol 2.0 54.0 52.0 lisdexamfetamine 10.400,000.0 12,000,000.0 1,600,000.0 meperidine 5,200,000.0 5,500,000.0 300,000.0 meperidine - intermediate A 3.0 5.0 2.0 meperidine - intermediate B 7.0 9.0 2.0 meperidine - intermediate C 3.0 5A 2.0 morphine-N-oxidc 6054)' 655.0 50.0 10,502.0 20.502.0 10.000.0 nabilone i i pentobarbital 31,000,000.0 34,000,000.0 3,000,000.0 phenylacetone 8.000,000.0 16,000,000.0 8,000,000.0 properidine 2.0 2.0 tapentadol 243,000.0 5,400,000.0 5,157,000.0
Vol. I Page 437 Billing Code 4410-09-M
DEPARTMENT OF JUSTICE-
Drug Enforcement Administration
[Docket No. DEA # 358E]
Controlled Substances: Established Aggregate Production Quotas for 2012
AGENCY: Drug Enforcement Administration (DEA), Department of Justice.
ACTION: Notice.
SUMMARY: This notice establishes the initial 2012 aggregate production quotas for controlled substances in Schedules I and II of the Controlled Substances Act (CSA).
EFFECTIVE DATE: [INSERT DATE OF PUBLICATION IN FEDERAL REGISTER]
FOR FURTHER INFORMATION CONTACT: John W. Partridge, Office of Diversion
Control, Drug Enforcement Administration, 8701 Morrissette Drive, Springfield, VA 221 52,
Telephone: (202) 307-7165.
SUPPLEMENTARY INFORMATION: Section 306 of the Controlled Substances Act (CSA)
(21 U.S.C. 826) requires that the Attorney General establish aggregate production quotas for each basic class of controlled substance listed in Schedules I and II. This responsibility has been delegated to the Administrator of the DEA by 28 CFR 0. 1 00.
The 2012 aggregate production quotas represent those quantities of Schedule I and II controlled substances that may be produced in the United States in 2012 to provide adequate supplies of each substance for the estimated medical, scientific, research, and industrial needs of the United States, lawful export requirements, and the establishment and maintenance of reserve
1
Vol. I Page 438 stocks. 21 U.S.C. 826(a) and 21 CFR 1303.11. These quotas do not include imports of controlled substances for use in industrial processes.
On October 2 1 , 20 1 1 , a notice entitled "Controlled Substances: Proposed Aggregate
Production Quotas for 2012" was published in the Federal Register (76 FR 65537). That notice . proposed the 2012 aggregate production quotas for each basic class of controlled substance listed in Schedules I and II. All interested persons were invited to comment on or object to the proposed aggregate production quotas on or before November 21,2011.
Sixteen responses (eleven from DEA registered manufacturers, and five from other members of the public) were received within the published comment period, offering comments on a total of 37 Schedule I and II controlled substances. Several comments discussed the national prescription drug abuse epidemic and urged DEA to reduce quotas for prescription painkillers and opioids. Addressing prescription drug abuse requires a multi-faceted approach which includes education, treatment, and enforcement.
The quota system is specifically designed to operate within the statutory framework of the
CSA, in conjunction with other controls to enable DEA to monitor the movement of controlled substances and certain chemicals into and through the closed system of distribution to help prevent diversion of such substances into the illicit market. Through the quota system, DEA limits the amount of those substances and chemicals manufactured each year to those quantities that will provide for the estimated medical, scientific, research, and industrial needs, lawful export requirements, and the establishment and maintenance of reserve stocks for the United
States. All aspects of the closed system of distribution must work together to reduce or eliminate the diversion of controlled substances.
2
Vol. I Page 439 Other commentcrs stated that the proposed aggregate production quotas for alfentanil, amphetamine (for sale), codeine (for conversion), codeine (for sale), dihydrocodeine, dihydromorphine, diphenoxylate, hydrocodone (for sale), hydromorphinol, levorphanol, lisdexamfetamine, meperidine, meperidine intermediate A, meperidine intermediate B, meperidine intermediate C, methadone, methadone intermediate, methamphetamine, methylphenidate, morphine (for conversion), morphine (for sale), morphine-N-oxide, nabilone, noroxymorphone (for conversion), noroxymorphone (for sale), opium (tincture), oripavine, oxycodone (for conversion), oxycodone (for sale), oxymorphone (for conversion), oxymorphone
(for sale), pentobarbital, phenylacetone, properidine, sufentanil, tapentadol, and thebaine were insufficient to provide for the estimated medical, scientific, research, and industrial needs of the
United States, export requirements, and the establishment and maintenance of reserve stocks.
In determining the aggregate production quotas, DEA has taken into consideration the above comments along with the factors set forth at 21 CFR 1303.11(b), in accordance with
21 U.S.C. 826(a), and other relevant factors including the consideration of 201 1 manufacturing quotas, current 201 1 sales and inventories, 2012 export requirements, additional applications for quotas, as well as information on research and product development requirements. Based on this information, DEA determined that adjustments to the proposed aggregate production quotas for alfentanil, dihydrocodeine, diphenoxylate, hydromorphinol, lisdexamfetamine, meperidine, meperidine intermediate A, meperidine intermediate B, meperidine intermediate C, morphine-
N-oxide, nabilone, pentobarbital, phenylacetone, properidine, and tapentadol are warranted. This notice reflects those adjustments.
When DEA published the Proposed Aggregate Production Quotas for 2012 on
3
Vol. I Page 440 October 21, 201 1, that notice proposed that all Schedule 1 and II controlled substances included
in 21 CFR 1308.11 and 1308.21 but not specifically referenced in that notice be established at
zero. That reference extended to the three synthetic cathinones (4-methyl-N-methylcathinone;
3,4-methylenedioxy-N-methylcathinone; and 3,4,melhylenedioxypyrovalerone) that were
temporarily placed in Schedule I pursuant to the final order also published on October 21, 201 1,
at 76 FR 65371. No comments were received within the published comment period regarding
the proposed quota for the three synthetic cathinones, however, DEA has determined, based on
the information described above, that an increase from the proposed quota of zero is warranted
for all three substances. This notice reflects those adjustments.
Regarding amphetamine (for sale), codeine (for conversion), codeine (for sale),
dihydromorphine, hydrocodone (for sale), levoiphanol, methadone, methadone intermediate,
methamphetamine, methylphenidate, morphine (for conversion), morphine (for sale),
noroxymorphone (for conversion), noroxymorphone (for sale), opium (tincture), oripavine,
oxycodone (for conversion), oxycodone (for sale), oxymorphone (for conversion), oxymorphone
(for sale), sufentanil, and thebaine, DEA has determined that the proposed initial 2012 aggregate
production quotas are sufficient to meet the current 201 2 estimated medical, scientific, research,
and industrial needs of the United States. This notice finalizes these aggregate production quotas
• at the same amounts as proposed.
In accordance with 21 U.S.C. 826 and 21 CFR 1303.1 1, the Administrator hereby
determines that the 2012 aggregate production quotas for the following controlled substances,
expressed in grams of anhydrous acid or base, be established as follows:
4
Vol. I Page 441 Basic Class - Schedule I Established 2012 Quotas l-[2-(4-Morpholinyl)ethyl1-3-(l-naphthoyl)indole (JWH-200) 45 e 1 -Butyl-3-( 1 -naphthoyl)indole (JWH-073) 45 g l-Methyl-4-phenyl-4-propionoxypiperidine IS 1 -Pentyl-3-( 1 -naphthoyl)indole (JWH-0 1 8) 45_S. 2,5-Dimethoxyamphctamitie lA 2,5-Dimcthoxy-4-ethylamphetamine (POET) 2g 2,5-Dimethoxy-4-n-propylthiophenethylamine la 3-Methylfentanyl IS 3-Methylthiofentany l \ ^ IS 3,4-Methylenedioxyamphetamine (MDA) 22_g. 3,4-Methylenedioxy-N-ethylamphetamine (MDEA) ill 3,4-Methylenedioxy-N-methylcathinone (methylone) la 3,4-Mcthylcnedioxymcthamphetamine (MDMA) US 3 ,4-Methylenedioxypyrovalerone (MDPV) Sg. 3,4,5-Trimethoxyamphetamine IS 4-Bromo-2,5-dimethoxyamphetamine (DOB) la 4-Bromo-2,5-dimethoxyphenethylamine (2-CB) la 4-Methoxyamphetamine 21A 4-Methylaminorex 2g 4-Methyl-2,5-dimethoxyamphetamine (DOM) Is 4-Methyl-N-methylcathinone (mephedrone) la 5-(l,l-Dimethylheptyl>2-[(lR,3S)-3-hydroxycyclohexyl}-phenol 68 g 5-(l,l-Dimethyloctyl>2-[(lR,3S)-3-hydroxycyclohexyl}-phenol 53 s 5-Methoxy-3,4-methylenedioxyamphetamine Is. 5-Methoxy-N,N-diisopropyItryptamine la Acetyl-alpha-methylfentanyl la Acetyldihydrocodeine la Acetylmethadol Is. Allylprodine la Alphacetylmethadol la Aipha-cthyltryptamine la Alphamcprodine la Aiphamethadol la Alpha-methylfentanyl la Alpha-methylthiofentanyl la Alpha-methyltryptamine (AMT) la Aminorex la Benzylmorphine la Betacetylmethadol la Beta-hydroxy-3-methylfentanyl la Beta-hydroxyfentanyl la
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Vol. I Page 442 Betameprodine 2 & Betamethadol 2g Betaprodine IS Bufotenine Al Cathinone 4_g. Codeine-N-oxide 602 g Diethyltryptamine liL Difenoxin 50 g Dihydromorphine 3,608,000 g Dimethyltryptaroine l£ Gamma-hydroxybutyric acid 47,000,000 g Heroin 20 e Hydromorphinol 54 g Hydroxypethidine lA Ibogaine 1a Lysergic acid diethylamide (LSD) 16 g Marihuana 21,000 g Mescaline 5g Methaqualone 10£ Methcathinone is. Methyldihydromorphine 2A Morphine-N-oxide 655 g N-Benzylpiperazine 1A N,N-Dimethylamphetamine lA N-Ethylamphetamine lA N-Hydroxy-3,4-methylenedioxyamphetamine 2g .Noracymethadol lA Norlevorphanol HA Normethadone lA Normorphine ili Para-fluorofentanyl lA Phenomorphan lA Pholcodine lA Properidine 2g Psilocybin 2jL Psilocyn lA Tetrahydrocannabinols 393,000 g Thiofentanyl lA Tilidine 10g Trimeperidine 2g
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Vol. I Page 443 Basic Class - Schedule II Established 2012 Quotas 1 -Phenylcyclohexylamine 2g 1-piperdinocyclohexanecarbonitrile 1& 4-Anilino-N-phenethyl-4-piperidine (ANPP) 1,800,000 g Alfentanil 15,000 g Alphaprodine 2jL Amobarbital 40,007 g Amphetamine (for conversion) 8,S00,0Q0 g Amphetamine (for sale) 25,300,000 g Cocaine 216,000 r Codeine (for conversion) 65,000,000 g Codeine (for sale) 39,605,000 g Dextropropoxyphene H Dihydrocodeine 400,000 g Diphenoxylate 900,000 g Ecgonine 83,000 g Ethylmorphine AjL Fentanyl 1,428,000 g Glutethimide IK Hydrocodone (for sale) 59,000,000 g Hydromorphone 3,455,000 g Isomethadone Levo-alphacetylmethadol (LAAM) 1A Levomethorphan Is. Levorphanol 3,600 g Lisdexamfetamine 12,000,000 g Meperidine 5,500,000 g Meperidine Intermediate-A IB. Meperidine Intermcdiate-B IS Meperidine Intermediate-C 5g Metazocine • Methadone (for sale) 20,000,000 g Methadone Intermediate 26,000,000 g Methamphetamine 3,130,000 g [750,000 grams of levo-dcsoxyephedrine for use in a non-controlled, non-prescription product; 2,331,000 grams for methamphetamine mostly for conversion to a schedule III product; and 49,000 grams for methamphetamine (for sale)1 Methylphenidate 56,000,000 g Morphine (for conversion) 83,000,000 g Morphine (for sale) 39,000,000 g Nabilone 20,502 g Noroxymorphone (for conversion) 7,200,000 g
7
Vol. I Page 444 Noroxymorphone (for sale) 401,000 g Opium (powder) 63,000 g Opium (tincture) 1,000,000 g Oripavine 9,800,000 g Oxycodone (for conversion) 5,600,000 g Oxycodone (for sale) 98,000,000 g Oxymorphone (for conversion) 12,800,000 g Oxymorphone (for sale) 5,500,000 g Pentobarbital 34,000,000 g Phenazocine Phencyclidine 24^ Phenmetrazine 2g Phenylacetone 16,000,000 g Racemethorphan Remifentanil 2,500 g Secobarbital 336,002 g Sufentanil 5,000 g Tapentadol 5,400,000 g Thebaine 1 16,000,000 g
The Administrator further determines that aggregate production quotas for all other
Schedule I and II controlled substances included in 21 CFR 1308.11 and 1308.12 be established
at zero. All aggregate production quotas are subject to adjustment pursuant to 21 CFR 1303.13.
Dated: Michele M. Leonhart Administrator
8
V.
Vol. I Page 445 OC: OD: OD/D:_ ODX:_ ODXL; ODXS: CC: CCR: ODW: ODQ:CAS_ ODEQ:p6T ]1 2-02- 11 S:\ODQ\Fed Reg\2012 Established Aggregate Production Quota Webcims # ODE- 1 1-654 (DFN: 630-08 -Quotas)
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Vol. I Page 446 201 1 final Rev Comments ) ) V
Drag Company 1 Camani Amoonl RcipOflSf Prepaid APQ t»uMi
Ncmtxr afregbifaeu/Mlitlfs com a eating: 15 (Ave non-registrants) Number of drugi com m toted ea: 37 I five were for reduction ofall opioid dregs)
Vol. I Page 447 701 1 Final Ravi- Comments ) ) )
Addiltaail Comidffikin*: Rni'twl Change Drat Reasons* Proposed. i|*nf la shifl from importation io domrtilc manufacturing once FDA approval is granted for their manufacturing (b)(4) f1 E.COO.OQO.O 16.DOO.OOO ft 3,000.000.0 pKcT)y1'4cct0ftC process in .2012 fhW4^ kurrently Vol. I Page 448 (b)(4) RECEIVED ODE 201 1 NOV 21 PK 2: S3 Drug Enforcement Administration Office of Diversion Control Attn: DEA Federal Register Representative/OD 8701 Morrissette Drive Springfield, VA 22152 November 14, 2011 Re: Docket Number DEA-358 Dear Sir or Madame: This comment is in response to Federal Register Docket Number DEA-358, the Proposed Aggregate Production Quotas for 2012 as published on October 21, 201 1. This letter contains Confidential Business Information highlighted with red print, to be redacted prior to online publication or posting. The proposed aggregate production quota listed for Noroxymorphone (for sale) is 401,000 grams. Our firm requests that this quota be increased to at least 1,200,000 grams, which is the quantity our firm expects to manufacture during 2012. Our firm is under contract to gjw a multinational pharmaceutical firm, to manufacture the bulk Active Pharmaceutical Ingredient (API) for mPEG-Naloxol, also known as NKTR-118. This material has been deemed by DEA to be a derivative of noroxymorphone (drug code 9668), pursuant to a Controlled Status Determination letter from DEA dated July 17, 2010. We have received a letter of intent from|(b)(4) ] indicating that they expect to purchase 1,200 kilograms of NKTR-118 oxalate salt from (b)(4) during 2012. A copy of that letter is attached. At a conversion rate of 0.88, 1 ,200 kg of oxalate salt equates to 1 ,056 kilograms of base. We are requesting that the aggregate be increased to allow the manufacturing of that quantity of material, as well as a small percentage of overage, to provide for a year-end inventory to meet requirements for the first quarter of 2013, as well as a quantity required for sampling and production losses. (b)(4) Vol. I Page 449 (b)(4) Drug Enforcement Administration November 14, 201 1 Your consideration of this request is appreciated. If vou have any questions, or require further information, please telephone me at rl<6' Ior contact me via e-mail atf»b><6> | • L Sincerely, (b)(6) DEA Regulatory Specialist attachment: a/s (b)(4) Vol. I Page 450 (b)(4) (b)(4) Sodertalje 11 November, 2011 (b)(4) is having the compound NKTR-118 oxalate in an R&D clinical programme, and preparations for commercial manufacturing of the Drug Product are on going. We intend to have 1200 kgs of NKTR-1 18 oxalate under drug code for noroxymorphone manufactured at fb)(4) (b)(4) )n 2012- Regards, (b)(4);(b)(6) (b)(4);(b)(7)(E) • 3 a Vol. I Page 451 RECEIVED ODE [I] CONFIDENTIAL 2011 NOV 18 AM 6: 35 SENT VIA E-MAIL November 1 6, 20 1 1 DBA Headquarters Attention: DEA Federal Register Representative/ODL 8701 Morrissctte Drive Springfield, VA 22152 Subject: Docket No. DEA-358 Dear Sirs: (b)(4);(b)(6) manufacturing registration [b)ffl;(b)(7)(E) ^ am submitting this comment on the 2012 Proposed Aggregate Production Quota for various products as published in the October 21, 201 ! Federal Register. We consider the information in this first paragraph to be "PERSONAL IDENTIFYING INFORMATION" and this information should not be released under the Freedom of Information Act per 5 (JSC Sec. 552(b)(4). In addition, the following information is "CONFIDENTIAL BUSINESS INFORMATION". The following items' manufacturing quota should be increased by the identified quantity: (i) Alfentanil by 3,500 grams as base; (ii) Amphetamine (for sale) by 3,200,000 grams as base; (iii) Codeine (for conversion) by 1,100,000 grams as base; (iv) Dihydromorphine by 300,000 grams as base; (v) Diphenoxylate by 15,000 grams as base; (vi) Hydrocodone by 3,020,000 grams as base; (vii) Meperidine by 26,800 grams as base; (viii) Melhamphetamine by 8,000 grams as base; (ix) Metliy lphen idate by 2,1 50,000 grams as base; (x) Sufentanil .by 300 grams as base; (xi) Hydromorphinol by 1 gram as base; (xii) Pethidine Intermediate A by 1 gram a base; (xiii) Pethidine Intermediate B by 1 gram as base; (xiv) Pethidine Intermediate C by I gram as base; and (xv) Properidinc by I gram as base. As noted herein, this first paragraph of this letter contains personal identifying and confidential business information and should be redacted in its entirety from any public docket. We fee! the proposed quantities for the material mentioned above is not sufficient to provide for adequate supplies for the medical, scientific, research and industrial needs of the United States, and for the lawful export requirements, and that the quotas should be increased to cover our needs. The appropriate DEA Form 1 89 will be or have been submitted pertaining to the items for which we submitted comments. Very truly yours Vol. I Page 452 received Q] CONFIDENTIAL SENT VIA E-MAIL 201 1 NOV 18 AH 6: 35 November 1 6, 20 1 1 DEA Headquarters Attention: DEA Federal Register Representative/ODL 8701 Morrissette Drive Springfield, VA 22152 Subject: Docket No. DEA-3 58 Dear Sirs: r> (b)(4);(b)(6) manufacturing registration fb)(4);(b)(7)(E) | am submitting this comment on the 2012 Proposed Aggregate Production Quota for various products as published in the October 21, 201 1 Federal Register. We consider the information in this first paragraph to be "PERSONAL IDENTIFYING INFORMATION" and this information should not be released under the Freedom of Information Act per 5 USC Sec. 552(b)(4). In addition, the following information is "CONFIDENTIAL BUSINESS INFORMATION". The following items' manufacturing quota should be increased by the identified quantity: (t) Meperidine by 93,000 grams as base; (ii) Methadone by 805,000 grams as base; (iii) Methadone Intermediate by 1,500,000 grams as base; and (jv) Morphine (for conversion) by 900,000 grams as base. As noted herein, this first paragraph of this letter contains personal identifying and confidential business information and should be redacted in its entirety from any public docket. We feel the proposed quantities for the.material mentioned above is not sufficient to provide for adequate supplies for the medical, scientific, research and industrial needs of the United States, and for the lawful export requirements, and that the quotas should be increased to cover our . needs. The appropriate DEA Form 189's will be or have been submitted pertaining to the items for which we submitted comments. Very truly yours Vol. I Page 453 (b)(4) RECEIVED ODE 201 1 NOV 16 AH 9= 02 (b)(4);(b)(6) DEA Headquarters Attn: DEA Federal Register Representative/OD 8701 Morrissette Drive Springfield, VA 22152 November 11, 2011 Subject: Docket No. DEA-358 - Morphine-N-oxide Dear Federal Register Representative By the end of November, (b)(4);(b)(7)(E) will be requesting to be registered as a manufacturer of Morphine-N-oxide. We are providing comment to the proposed aggregate production quota for 2012 for Morphine-N-oxide. (b)(4) is requesting the aggregate be increased by at least 50 grams to allow sufficient aggregate for fW) |to be granted 50 grams of manufacturing quota in order to manufacture Morphine-N-oxide as a reference standard to be used in the analysis primarily of Morphine Sulfate but also other opiate drug products and drug substances. Morphine-N-oxide is a potential known impurity in Morphine Sulfate and possibly other opiates. (b)(4) respectfully requests that the 2012 aggregate production quota for Morphine-N- oxide be increased by at least 50 grams to allow for our request. If you have any questions or require additional information, please feel free to contact me directly. Sincerely (b)(4);(b)(6) DEA Compliance Manager (b)(4) Vol. I Page 454 (b)(4) RECEIVED ODE 201 1 NOV 16 AM 9: 02 (b)(4);(b)(6) DEA Headquarters Attn: DEA Federal Register Representative/OD 8701 Morrissette Drive Springfield, VA 221 52 November 11, 2011 Subject: Docket No. DEA-358 - Hydromorphinol Dear Federal Register Representative, (b)(4) is a registered manufacturer | :b)(4) is requesting the aggregate be increased by at least 50 grams to allow sufficient aggregate for fbK4) |to be granted 50 grams of manufacturing quota in order to manufacture Hydromorphinol as a reference standard to be used primarily in the analysis of Oxymorphone but also other opiate drug product and drug substances. Hydromorphinol is a potential known impurity in Oxymorphone and our Oxymorphone customers have already requested this reference standard. (b)(4) respectfully requests that the 2012 aggregate production quota for Hydromorphinol be increased by at least 50 grams to allow for our request. If you have any questions or require additional information, please feel free to contact me directly. Sincerely, (b)(4);(b)(6) DEA Compliance Manager (b)(4) Vol. I Page 455 CONFIDENTIAL BUSINESS INFORMATION (b)(4) RECEIVED ode: 201 1 NOV 2 1 PH1)!32 18 November 2.01 1 DEA Federal Register Representative/OD 8701 Morrissette Drive Springfield, VA 22152 RE: Docket No. DEA-358 Proposed Revised Aggregate Production Quotas for 2012 Tapentadol (9780) CONFIDENTIAL BUSINESS INFORMA TION !b)(4) requests that the DEA revise the 2012 aggregate production quota to establish at least 1200 kg ol 201 1 Tapentadol aggregate manufacturing quota. |(b)(4)'(bK7KE) 'is developing tapentadol hydrochloride to support several generic pharmaceutical companies who plan to file generic versions of this active pharmaceutical ingredient (API). The goal for these companies is to submit Abbreviated New Drug Applications (ANDA) in late 2012. To' support this development schedule, manufacturing quota in excess of the Proposed Aggregate Production Quota for 2012 (Docket DEA-358) will be required. (b)(4) anticipates two manufacturing campaigns in 2012. The first will conclude in January 2012. This campaign is a continuation of production started in December 201 1 . |(b)(4> had hoped to complete this campaign in 201 1, but manufacturing delays will require a portion of this production to slip into January 2012. The second campaign is planned for March-April 2012. This will allow API to be formulated and stability studies completed to support ANDA submission in Q4 2012. |M(4> ~{anticipates manufacturing requirement -900 kg (900,000 grams) in 20 1 2 to meet these needs. Customers have provided the following forecasts for Tapentadol HC1 demand in 2012: CONFIDENTIA L BUSINESS INFORMA TION Customer Demand base form (kg) (b)(4) 154.8 258.0 129.0 116.1 77.4 172.0 TOTAL 907.3 "iibiw (b)(4) Page 1 of 2 Vol. I Page 456 CONFIDENTIAL BUSINESS INFORMATION The customer forecasts total 907.3 kg (base); the 243 kg proposed 2012 aggregate quota will not be sufficient to support these customers. |(b>(4> 1 requests that the DEA revise the 2012 aggregate production quota to establish at least 1200 kg of Tapentadol aggregate manufacturing quota. lhas only requested 120 kg ofquota for 2012 but due to the latest numbers forecasted by our customers, we will be submitting an increased 2012 quota request to support our planned 2012 campaigns. This aggregate quota increase is essential to support the development ofgeneric drug version of this drug in accordance with U.S. Drug Price Competition and Patent Term Restoration Act of 1984. Thank you for your consideration of this request. P esnectfully vours 1(b)(6) Director of US Operations (b)(4) Page 2 of 2 Vol. I Page 457 file:///C:/D0CUME~3/User/L0CALS~ I /Temp/DHA-201 1-00 14-D... REg/VED As of: November ziyiM 1. 1 Receive^ ^Qxember 21, 2011 PUBLIC SUBMISSION Status: ? Docket: DEA-20II-00L4 Controlled Substances: Proposed Aggregate Production Quotas for 2012 ae Comment On: DEA-20 11 -00 14-0001 CD 33 •c m Controlled Substances: Proposed Aggregate Production Quotas for 2012 rv> On am rn-c -a rn Document: DEA-201 1-O0I4-DRAFT-OOO6 3E C? Comment on FR Doc U 20 1 1-27283 fj . TV Submitter Information Name: <6> Address: b)(4) Email: tb)(4):(b)(6) Phone: Fax: pK6) Organization: 1(b)(4) General Comment The attached file constitutes|(b)(4) jcommcnts on the Proposed Initial Aggregate Production Quotas for 2012, as published in the Federal Register on October 21, 20 1 1, FR Vol. 76. !b)(6) Supervisor, Controlled Substance Compliance b)(4);(b)(6) Attachments 2012 Initial Aggregate Comment 'b)(4):(b)(7)(E) Vol. I Page 458 (b)(4) • ) (b)(4) 3 ! ! ! i November 21, 2011 Acting Deputy Administrator Drug Enforcement Administration Washington, D.C. 20537 Attn: PEA Federal Register Representative [Docket No. DEA-3581 This letter constitutes comments on the Proposed Initial Aggregate Production Quotas for 2012, as published in Federal Register on October 21, 2011, FR Vol. 76, No. 204, pages 65537-65540. I n I ight of the fact that (b)(4) ihas no knowledge of either the amounts of any available aggregate quotas or the planned allocation of any aggregate, (bM I: requests that DEA make any adjustments to the aggregate quotas sufficient to satisfy its requests for increased manufacturing quotas, which are outlined below. Because this comment contains proprietary information on its manufacturing quota needs, we also request that DEA treat this entire document as confidential. All requests below are stated in grams anhydrous base ("AA"). 9050 Codeine (for conversion) (b)(4) requests that the initial aggregate be sufficient to include its request for 36,000,000 grains AA of Codeine (for conversion) manufacturing quota for 2012. 9120 Dihydrocodeinc [(b)(4) requests that the initial aggregate be sufficient to include its request for 280,000 grams AA of Dihydrocodeine manufacturing quota for 2012. 9170 Diphenoxylate t (b)(4) requests that the initial aggregate be sufficient to include its request for 950,000 grams AA of Diphenoxylate manufacturing quota for 2012. Vol. I Page 459 November 21, 2011 DEA Federal Register Representative Page 2 of 3 (Docket- No, DEA-358] 9193 Hydrocodone (for sale) (b)(4) Requests that the initial aggregate be sufficient to include its request for ? 31,000,000 grams AA of Hydrocodone (for saie) manufacturing quota for 2012. < s 9220 Levorphanol . f (b)(4) | requests that the initial aggregate be sufficient to include its request for 6,100 grams AA of Levorphanol manufacturing quota for 2012. 9230 Meperidine (b)(4) requests that the initial aggregate be sufficient to include its request for 2,100,000 grams AA of Meperidine manufacturing quota for 2012. 1724 Methylphenidate (b)(4) requests that the initial aggregate be sufficient to include its request for 7,400,000 grams AA of Methylphenidate manufacturing quota for 2012. 9300 Morphine (for conversion) (b)(4) jrequests that the initial aggregate be sufficient to include its request for i 46,000,000 grams AA of Morphine (for conversion) manufacturing quota for 2012. i: I 9300 Morphine {for Sale) !: li (b)(4) requests that the initial aggregate be sufficient to include its request for 23,000,000 grams AA of Morphine (for Sale) manufacturing quota for 2012. 9668 Noroxymorphone (for conversion) (b)(4) requests that the initial aggregate be sufficient to include its request for 4,800,000 grams AA of Noroxymorphone (for conversion) manufacturing quota for 2012. 9630 Opium Tincture (b)(4) requests that the initial aggregate be sufficient to include its request for 1,000,000 grams AA of Opium Tincture manufacturing quota for 2012. 9330 Oripavine |(b)(4) jrequests that the initial aggregate be sufficient to include its request for 7,000,000 grams AA of Oripavine manufacturing quota for 2012. !: Contains Confidential and Proprietary Information ii 1 Vol. I Page 460 November 21, 201 1 DEA Federal Register Representative Page 3 of 3 [Docket No. DEA-358] I; i 9143 Oxycodone (for conversion) i (b)(4) requests that the initial aggregate be sufficient to .include its request for ;s Si 7,000,000 grams AA of Oxycodone (for conversion) manufacturing quota for 2012. Ll 9652 Oxymorphone (for conversion) [(b)(4) requests that the initial aggregate be sufficient to include its request for 7,000,000 grams AA of Oxymorphone (for conversion) manufacturing quota for 2012, 9652 Oxymorphone (for sale) (b)(4) requests that the initial aggregate be sufficient to include its request for 4,000,000 grams AA of Oxymorphone (for sale) manufacturing quota for 2012. 9740 Sufentanil (b)(4) requests that the initial aggregate be sufficient to include its request for 2,100 grams AA of Sufentanil manufacturing quota for 2012. All other quota requests remain unchanged from original request. Sincerely, ji (b)(6) ! i= i; Supervisor, Controlled Substance Compliance 8 b)(4);(b)(6) !i : >1 ii Contains Confidential and Proprietary information i Vol. I Page 461 fi I e:///C:/DOCUME~ 1/User/L0CALS~ 1 /Temp/DEA-20 11-0014-000... As of: November 16, 201 1 Received: November 16, 2011 Status: Posted PUBLIC SUBMISSION Posted: November 16, 20 11 TVacking No. 80f6dc4 1 Comments Due: November 21, 201 1 Submission Type: Web Docket: DEA-201 1-0014 Controlled Substances: Proposed Aggregate Production Quotas for 2012 Comment On: DHA-201 1-0014-0001 Controlled Substances: Proposed Aggregate Production Quotas for 2012 Document: DEA-201 1-0014-0002 Comment on FR Doc U 2011-27283 . V-.1 Submitter Information Name: Ada Giudice-Tompson Address: 452 Athabasca Drive ' 4 1 00 Gait Ocean Drive Fort Lauderdale, Florida 33308 U.S.A., Ontario, Canada, L6A3S2 Email: [email protected] Phone:905 417-3153 General Comment RE: Docket No. DEA-358 Controlled Substances: Proposed Aggregate Production Quotas for 2012 As a bereaved mother who lost my only child Michael to a prescribed opioid T offer these comments on the DEA's proposed aggregate production quotas for Schedule I and II opioids in 2012: • End the epidemic of death and addiction caused by prescription opioid drugs by ensuring that opioids are regulated, marketed and prescribed to patients who are terminally ill or short term for severe pain; not for long term use. • The destruction we have witnessed clearly highlights the inherent dangers of opioids. To focus on the misuse of opioids is to continue to cloak them in a veil of legitimacy. It is the responsibility' and duty of the DEA to significantly reduce the quotas for Schedule 1 and II drugs and avoid the overproduction and saturation of the market which has contributed to this epidemic of legally prescribed Heroin-like drugs. 11/ 1 6/20 11 2:26 PM 1 of2 Vol. I Page 462 filc:///C:/DOCUME~l/User/LOCALS~l/Temp/DEA-20 11-00 14-000... Sincerely Ada Giudice-Tompson 1 1/16/201 1 2:26 PM 2 of 2 Vol. I Page 463 November 6, 2011 Drug Enforcement Administration Attention: DEA Federal Register Representative/OD 8701 Morrissette Drive Springfield* VA 22152 RE: Docket No. DEA-358 Controlled Substances: Proposed Aggregate Production Quotas for 2012 On behalfofAdvocates for the Reform of Prescription Opioids, Inc. (ARPO), I offer these comments on the DEA's proposed aggregate production quotas for Schedule II opioids in 2012. ARPO foimed earlier this year with the goal of ending the epidemic of death and addiction caused by prescription opioid drugs by ensuring that opioids are regulated, marketed, prescribed and used in an evidence-based manner. Many of our members are bereaved parents who lost a child to prescription opioids. In my case, I lost my eighteen year-old daughter Emily after she consumed one OxyConttn pill given to her by a relative. Others in.our group are struggling with an addicted family member; the majority of these cases began due to an injury that led to an opioid prescription. The United States and other developed countries around the world .are currently in what has been termed a prescription drug epidemic. The term, "epidemic", has been used by Office ofNational Drug Control Policy Director Gil Kerlikowske, the Centers for Disease Control, National Insitute on Drug Abuse Director Nora Volkow, SAMHSA, coroners and others to refer to the prescription drag crisis we are currently facing. In her remarks before a Congressional' subcommittee earlier this year, DEA Administrator Michele Leonhart stated that "Prescription drug abuse is a serious problem. Reducing prescription drug abuse is vital to the health and welfare of the American people." (Leonhart 2011). Of some 35,450 deaths in the United States in 2008, more than 20,000 of these deaths were attributed to prescription drugs, and of those 14,800 deaths were attributed to prescription opioids (CDC 201 1). According to the DEA website, the mission of the Drug Enforcement Administration (DEA) is to enforce the controlled substances laws and regulations of the United States. In fulfillment of this mission, DEA establishes production quotas for Schedule I and II drugs every year. In her Congressional remarks earlier this year, Administrator Leonhart stated that "DEA establishes manufacturing and procurement quotas each year for schedule I and II controlled substances in order to avoid the overproduction of these substances, for the purpose of reducing the risk of diversion to illicit traffic. Accordingly, the quota system serves the vital purpose of reducing the risk ofdiversion" (Leonhart 201 1). If this is indeed the objective of the quota system, the 1 Administrator Leonhart also stated: "The economic impact on the United States from the non-medical use of prescription opioids in 2006 was estimated at $53.4. billion". Vol. I Page 464 following information casts serious doubt on the effectiveness of DEA's administration of its quota system. Here is a graph showing the steady increase in DEA production quotas for most Schedule II opioids: . 700000 600000 500000 400000 300000 200000 100000 0 1996 1997 1998 1999 2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 DEA Production Quotas for Schedule II Opioids, 1996-2009 (kg). Includes quotas for codeine, fentanyl, hydrocodone, hydromorphone, meperidine, methadone, morphine, opium, oxycodone, oxymorphone and thebaine. Source: DEA website. . In the United Stales during roughly this same time period, deaths from prescription opioids have risen in parallel with the increase in supply: 16000 14000 12000 10000 8000 6000 4000 2000 0 1999 2000 2001 2002 2003 2004 2005 2006 2007 2008 Annual deaths from opioid analgesics. United States, 1999-2008. Source: CDC. Vol. I Page 465 These two trend lines are clearly very highly correlated (Pearson correlation coefficient = 0.94 for years 1 999-2008), providing evidence of the close relationship between the supply of prescription opioids, as represented by the DEA quotas, and deaths from these same drugs. Following is a graph from the Centers for Disease Control that shows that the rate of deaths and treatment admissions attributed to prescription opioids have steadily risen in lock step with sales of prescription opioids in the United States: Rates of prescription painkiller sales, deaths and substance abuse treatment admissions (1999-2010). 8 Sales 7 6 Deaths 5 A? 0> £ 4 ; >; Treatment -A- Sales per kilograms per 10.000 people 3 l 2 i O"* Deaths per 100,000 people '9—- Treatment admissions per 10.000 people 1 i o i 0 N«^ 4 4 4 4 4 4 4 4 4 4 4 SOURCE: CDC Vital Signs, November 201 1. CDC references: National Vital Statistics System, f 999-2008; Automation of Reports and Consolidated Orders System (ARCOS) ofthe Drug Enforcement Administration (DEA), 1999-2010; Treatment Episode Data Set, 1999-2009 These graphics vividly establish that deaths and addictions from prescription opioids have continued to rise unabated as DEA production quotas have been increased. It is abundantly clear that the steadily increasing supply of opioids that is made possible through DEA's production quotas is driving the prescription opioid epidemic. The time has come for DEA to finally recognize that its production quotas enable the production of drugs that kill and addict thousands ofAmericans and other citizens throughout the world each year. Thus, DEA is directly responsible for enabling the American drug production system to mass produce huge quantities of narcotics that are killing people and destroying lives. To consider only the benefits that these medications provide is to ignore a major public health problem that is being driven by DEA's drug quota policies. With all of the problems brought on by the mass production of oxycodone in this country, a 2012 proposal to allow the production of 103,600 kg (114 tons), a 1,747% increase over the amount produced in 1996, the year OxyContin first came on the market, is unconscionable and reflects a complete disregard for the loss of life that this drug has caused. Vol. I Page 466 According to CDC, in 2010 about 12 million Americans aged 12 or older (about one in twenty) reported using prescription opioids nonmedically, enough to medicate every American adult around the clock for a month (CDC 201 1). This constitutes proof that these powerful and deadly narcotics have over-saturated our society. The DEA has approved these massive increases in the legal supply of prescription opioids without evidence that these narcotics are safe or effective for chronic noncancer pain. Rather than taking the drug companies' or FDA's word for it, why does DEA not conduct its own investigation on the efficacy of these drugs and how the drug companies propose to use them? A good place to begin your investigation is the website of Physicians for Responsible Opioid Prescribing (PROP) at: http://www.responsibleonioidnrescribing.org/. Our own website also provides up to date medical research on prescription opioids: http://www.rxreform.org/. The time has come for-DEA to do the right thing - it must roll back the production quotas to save lives. Sincerely, Peter W. Jackson, President Advocates for the Reform of Prescription Opioids www.rxreform.org References: CDC 2011. CDC Vital Signs. littD://www.cdc.gov/VitalSigns/PainkillerOverdoses/ffLatsstFindings CDC 2011. Vital Signs: Overdoses of Prescription Opioid Pain Relievers - United States, 1999 2008. Morbidity and Mortality Weekly Report, November 2, 2011. http://www.cdc.gQv/mm wr/r>review/mmwrhtml/mm6043a4.htm?s cid=tnm6oa-3aa w Leonhart, M. 2011. "Warning: The Growing Danger of Prescription Drug Diversion". Statement for the Record of Michele M. Leonhart, Administrator, Drug Enforcement Administration before the United States Department of Justice Subcommittee on Commerce, Manufacturing and Trade, Committee on Energy and Commerce, United States House of Representatives." April 14, 201 1. Vol. I Page 467 file:///C:/DOCUME~ l/User/LOCALS-1/Temp/DEA-201 1-00!4-000... As of: November 17,2011 Received: November 17, 201 1 Status: Posted PUBLIC SUBMISSION Posted: November 1 7, 201 1 - Tracking No. 80fGed6c Comments Due: November 21 , 201 1 Submission Type: Web Docket: DEA-20 11-00 14 Controlled Substances; Proposed Aggregate Production Quotas for 2012 Comment On: DEA-201 1-0014-0001 Controlled Substances: Proposed Aggregate Production Quotas for 2012 Document: DEA-20 11 -00 14-0004 Comment on FR Doc # 201 1-27283 Submitter Information Name: Jeremy S Mirabile Address: 301 Justice Lane Bunnell, FL, 32110 Phone:386-236-1748 Fax: 386-236-1823 Organization: Stewart-Marchman-Act Behavioral Healthcare General Comment Docket No DEA-358 As Deputy Medical Director for Addictions for the Stewart-Marchman-Act Behavioral Healthcare and the Director of the Vince Carter Sanctuary I am asking that you significantly cut back the production quotas for 2012. The market is already flooded with these drugs of which a significant percentage then becomes available on the street. I 1 of 1 11/17/2011 3:06 PM Vol. I Page 468 file:///C:/DOCUME~I/User/LOCM-S- i/Terap/DEA-20 11-001 4-000... As of: November 17, 201 1 Received: November 17, 201 1 Status: Posted PUBLIC SUBMISSION Posted: November 17, 201 1 Tracking No. 80f6ee67 Comments Due: November 21, 201 1 Submission Type: Web Docket: DEA-201 1-0014 Controlled Substances: Proposed Aggregate Production Quotas for 20 12 Comment On: DEA-201 1-0014-0001 Controlled Substances: Proposed Aggregate Production Quotas for 2012 Document: DEA-201 1-00 14-0005 Comment on FR Doc # 201 1-27283 Submitter Information Name: Trudy Duffy Address: 1011 Faulkner St New Smyrna Beach, FL, General Comment - Re: Docket No. DEA-358 Controlled Substances A recent Center for Disease Control report states "Enough prescription painkillers were prescribed in 201 0 to medicate every American adult around the clock for a month." We are living in the midst of a public health tragedy stemming from the damage inflicted on society by the use and oversupply ofprescription opioids. The quota system, which should serve to reduce the risk of diversion, could have either helped to avoid or reduce this epidemic. The rising level of public awareness and the lack of government oversight to date gives the DEA an opportunity to become an active participant in curbing this epidemic. Repo'rts generated by the CDC, USDHHS and NIH are all clear indicators of an oversaturation of the market with deadly consequences. In 9/11 terms, "the system is blinking red". I live in Florida where excessive unit doses are shipped. The manufacturers are aware of the oversupply, diversion and their culpability. The epidemic begins with production and in the past reducing manufacturing quotas cut abuse successfully for other drugs. Is the influence of the pharm companies driving the decision? Prescription opiods sanctioned by the government, over-promoted and highly prescribed, with known potential for abuse and diversion is a public health tragedy. The DEA must take action now. To not do so is unthinkable. In Volusia County, Florida a recent Drug Task Force Forum attracted over 300 participants. Our I of2 11/17/2011 4:26 PM Vol. I Page 469 file:///C:/DOClJME~l/User/LQCALS~l/Tenip/DEA-201 1-0014-000... courts, jails, hospitals and treatment facilities are now recognizing the ramifications of opioid addiction and are overwhelmed. Too many are suffering and too many have died. 1 urge you to read the data. You have the power and the responsibility to make a difference. 11/17/2011 4:26 PM v?n Vol. I Page 470 file:///C:/DOCUME~l/User/LOCALS~l/Tetnp/DEA-201 1-0014-000... As of: November 23, 201 1 Received: November 21, 20 1 1 Status: Posted PUBLIC SUBMISSION Posted: November 23, 201 1 TYacking No. 80f72703 Comments Due: November 21, 201 1 Submission Type: E-mail Docket: DEA-201I-0014 Controlled Substances: Proposed Aggregate Production Quotas for 2012 Comment On: DEA-20 1 1-00 14-0001 " Controlled Substances: Proposed Aggregate Production Quotas for 2012 Document: DEA-201 1-0014-0006 SG Comment 201 1-1 1-19 Submitter Information Name: S G Address: Myrtle Beach, SC, General Comment NOVEMBER 19, 2010 TO THE DRUG ENFORCEMENT ADMINISTRATION ATTENTION: DEA FEDERAL REGISTER REPRESENTA1IVE/OD 8701 MORRISSETTE DRIVE SPRINGFIELD,VA 22152 The proposal to allow the continued massive production quotas for 2012 of Schedule II opioids, such as 103,600 kg ofoxycodone, needs to be urgently re-asscsscd, especially in light of the mounting death toll caused by this and other prescription narcotics. As documented by the CDC, the growing volume of op io id-re latcd mortality is clearly related to the volume of opioid sales and prescribing, which have been excessive and inappropriate across the nation, especially for chronic noncancer pain. The promotion and marketing of OxyContin and other opioids for expanded use well beyond that of cancer pain, was based upon false premises in the absence of scientific validation, and done for commercial and political objectives and motivations. It is unfortunate that the DEA was swayed by the myths and misinformation spread by the opioid drug companies and a misguided pain 'management' industry dangerously overly-focused on narcotics. Over the past ten years, the risky practice of opioid overprescribing has lead to an - epidemic and public health crisis of addiction, abuse, crime, overdose and death Vol. I Page 471 file:///C.7DOCUME~l/User/LOCALS--l/Temp/DEA-2011-00 14-000... throughout the nation with no end in sight. Diversion of widely available and accessible prescription opioids has had a catastrophic effect on our youth, while providing many opioid-dependent and addicted patients with illegal sources of income and facilitating involvement in related criminal activities, which have significantly increased during these hard economic times.The death toli continues to rise, with over 6000 prescription opioid-related deaths in the state of Florida alone during 2010, with oxycodone accounting for about one-third of these, as per data from the Office of the Florida Medical Examiners. A group of medical experts have put together a website of medical information for physicians, containing multiple evidence-based studies including the recent CDC data, which seeks to reverse the dangerous practices and misconceptions about prescription opioids which underlie the disastrous consequences stemming from the massive overuse and oversupply of prescription narcotics, such as oxycodone. The link to this website can be accesssed at: www.responsibleopioidprescribing.org. It is apparent from the videos of this site that leaders in the pain management community have now re-assessed and reversed their initially misinformed attitudes about opioid prescribing, and now acknowledge the very clear risks of widespread, nonselective opioid use for chronic noncanccr pain, especially at higher doses, and the lack of evidence for their long-term effectiveness. It is hoped that the DEA will re-evaluate its position on production quotas for Schedule II opioids, and return to the initial approach it had ten years ago when it closed down the Comprehensive Pain Clinic of Myrtle Beach, SC, one of the nation's first 'pill mills'. If it had followed-up and adhered to the same strategy over the ensuing years, the current opioid epidemic with its mounting toll of addiction and death and the massive proliferation of the Florida 'pill-mills' [which are now spreading to other stales], could have been significantly curtailed. Sincerely, SO Myrtle Beach, SC 11/19/11 Vol. I Page 472 2012 Establish Initial Aggregate Production Quotas • Section 306(a) of the Controlled Substances Act (CSA) requires the Attorney General to establish limits on the production of schedules I and II controlled substances. This responsibility has since been delegated to the Administrator of the Drug Enforcement Administration (DEA). • The attached Federal Register notice, prepared for your signature, established initial year 2012 aggregate production quotas (APQ) for schedules I and II controlled substances for which the United States has medical, scientific, industrial, export and reserve stock requirements. Also attached is a list of the 2010 and proposed 201 1 APQs for these substances for comparison. • Expeditious publication of this notice is necessary to ensure that quota is available at the beginning of 2012 for manufacturing. The following points provide brief explanations of the changes from the proposed APQ values: • Schedule I substances • The APQ for 4-methyl-N-methyIcathinone, 3,4-methylenedioxy-N-methylcathinone, 3,4,methylenedioxypyrovalerone, hydromorphinol, morphine-N-oxide, and properidine were increased due to additional applications received to support the manufacturing of diagnostic kits and or reference standards. • The APQ for gamma hydroxybutyric acid was increased to support new product development and validation efforts. Schedule II substances • The APQ for alfentanil and lisdexamfetamine were increased to support increased exportation requirements. • The APQ for meperidine intermediate A, meperidine intermediate B, and meperidine intermediate C were increased due to additional applications received to support the manufacturing of diagnostic kits and or reference standards. • The APQ for nabilone and tapentadol were increased to support new product development and validation efforts which would allow for the domestic manufacturing of these substances. • The APQ for dihydrocodeine, diphenoxylate, meperidine, pentobarbital and phenylacetone were increased due to additional applications received to support the manufacturing efforts. • The APQ for noroxymorphone (for sale) was not increased to support new manufacturing of NKTR-1 18, or mPEG-Naloxol which falls under the basic drug class noroxymorphone. Vol. I Page 473 Aggregate Production Quotas (all values are In grams unless indicated otherwise) Final Revised Proposed Initial Controlled Substance Final Revised Initial Initial 2011 2012 20l2~ Schedule I: 2010 2011 45 4? 45 l"-f2"-"(4-Morpholinvl']eUi"vll-3-(1-napfithovl)indole (jWH-200) 0 0 '.t. 1-BulvKS-n-raohthovllindole (JWH-073) 0 0 • 45 45: 45 1-MBthyj-4-phenyM-propiondxypiperidine 0 2 2 2 ?i 45 1-Penlyl-3-(1-raphthoyl)iridole (JWH-016) 0 0 45 45: r 2.5-Oimetfioxyamphetamine 2! 2 T. 2 2 2.5_-6imethoxy^4-Elhylamphetamine (POET) 2 2 2 2 2 2>-Diinethoxy-^(nj-propylthiophenethylamine 0 2 2 2 3-Metliylfentariyl 2 2 2! 2 2 3-Melhyithiofenlanyl 2 2 2 2 2 3.4-Metlivlenedioxvamphetaroine (MDA) . _ 20 22 22; 22 22 3.4-Methylenedioxy-N-Elhylamphelamine (MDEA) 10 15 15 IS 15 3,4-Methylenedioxy'N-melhylcalhinone (methylore) 8 3.4-Methyieredioxyrr,elhamp*h'etamine (MDMA) 20" 22 22 22 22 3.4-Methvtenedioxypyrovaierone (MDPV) e 3.4,5-Tfimethoxyamphetamine 2 2 2 2 2 4-Bromo-2.5-Dimethoxyamphetamine (DOB) . 2'. 2 2 2 2 4-Bromo-2.5-bimelhoxypfienethylamine (2-CB)" 2 2 2 2 2 4-Methoxyamphetamine 77 77 77 77 77 4-Methyiaminorex 2 2 2 2 2 4-Me{~hyl-2,5-Dirr»etnoxyamphetamirie (POM) 2 2 2 2 2 4-Methyl-N-methyicalhinone (mephedrone) 8 5-(1 ,i-Pimethylhep'tyl)-2-[(1R.3"sil3-hydroxycyctohexyl)-phenol 0 0 6B 68 ' 68 5-(1,l"-Dimeihyloctyl)-24(1R,3S)-3-hyd'roxycyclohexyl1-pheno1 0 0 53 53 53 5-Mei"hoxy-3.4-"Methvlenedioxyamphetamine 2 2 2 2 2 5-Melhoxy-N,N-diisopropyltryptamirie 0 2 2 2 2 Acetyi-alpfra-methylfenlanyl 2 2 2 2 ACQlyldihydrocodeine 2 2 2 2 2 Acetylmethadoi " ' " 2 2 2 21 2 Allylpradine 2 2 2 2' 2 Alphacetylmelhadol 2 2 T" 2: 2 Alpha-ethyltiyptamine 2 2 2 2 2 Alphameprodine 2 2 2 2 2 Alghamethadol 2 2 2 2 2 Alpha-methylfentanyl 2 2 2 2 2 Alpha-methylthiofentanyl 2 2 2 2 . 2 Alpha-methyltiyptamine (AMT) 2 " 2 2 2 Aminorex 2 2 2 2 2 2 Benzylmorpjiine 2 2 2 2 Belacetylmethadol 2 2 2 2 2 Bela-hvdroxy-3-methvifenta nyl 2 2 2 2 2 • --T Bela-hyd roxyfenlanyl 2 '2 2 2 Belarneprodine _ _ . 2 2 J... 2 2 Belamethadol 2 2 2 2 2 Beiaprodine 2 2 2 2 2 3 Bjfotemne 3 3 3 3 4 4 Cathinone ... 3 4 4 602 Codeine-N-Oxide 602 602 602 602 2 Diethyllryptamine 2 2 2 2 60 50 50 DUenoxin 3.000 3.000 pThydromorphine ^ 3.606,000 3,608,000 3,608,000 3,608.000 3,608.000 7 7 0 imelhyltryptamine 3 7 7 Gamrra-hydroxybJtyric acid 52.156.000 3.000,000. 5.772,000 29,000,000! 47,000.000 20' 20 i 20 Heroin 20 20 54 Hydromorphinol 2 2 2 "21 2 2 HydroxypeJWdine_ . , . 2 2 2 5 5 lbogaine _ 1 5 5 16 16 Lysergic Acid Diethylamide 15 16 16 21,000 21,000 21.000 21,000 Marihuana _ 21,000 5 5 Mescaline 5 5 5 10 10 Methaqualone 7 10 10 4 4 Melhcathinone 4 4 4 2 2 2 MethyldihydromoDhine 2 2 : 605 655 Moiphine-N-oxide 605 1 605I 605 — 2 N-Berizylpiperazine " 2 2 2 2 Page 1 Vol. I Page 474 Aggregate Production Quotas (all values are in grams unless indicated otherwise) Final Revised | Final Revised Initial Final Revisedi Proposed [Controlled substance i I Initial 2010 2011 2011 2012 Schedule!:, 2009 0 0 45 45 1-[2-(4-Morpholi nyIJelhyI i-(1 -nai 0. tiUty|V^i.n^4^j^e(JWH'-073L " 0 0 0 45 45 2 ' l-Methvl-a-phenvi-4-propioroxypiperidine 0 0 2 2 i-Pentylj-tl-naphthovlilndole (JWH-018) 0 "0 0 45 45 2,5-Dimeir>"oxyarrphetamine 2 2 2 2 2 2,5:Dimelh^^EthylOT£lietamine (DOET] . _ . 2: 2 2 2 2 2.5-Dimethoxy:4-(n)-propylthiophenethylamine 0 0 2 2 2 3-^thylfentanyl_ 2! 2 2 2 2 2 2 2 3-Methylthiofentany l 2 2 3.4-Methvlenedioxyamphetarnlne*(MPA) . 25 20 22 22 22 3,4-Metfivlened'ioxy-N-Ethylamphetamine (MDEA) 10 10 15 15 15 20 22 22 22 l4-Methylenedioxvrnethamphstamine(MDMA) 20 2 3,4,5-ffimeilioxvamphetamine 2 2 2 2 2 4-Bromo-2.5-"Oimelhoxyamphetamirie (DOB) 2 1!" 2 4-8romo-2.5-Dimeth"oxyphene'thylamine (2-CB)_ 2 2 2 21 2 77 4-Melhoxyamphetamine 27 77 w: 2 4-Methylamjnorex 2 2 2 4-Meihyl-2,5-Dimethoxyamphetamine (DOM) 21 2 2 2 2 5.il!.DimethyiheDtylV2-f7lR.3Sl-3-hvd"roxveyclohexyH-phen( 01 0 0 66i "69 5-(t,1-Dimethyloctyl)-2-r(1R.3S)-3-hydroxycyclohexylKphenol 0 0 0 531 53 5-Metho'xy-3,4-Methylenedioxyamphetamine 2 2 2 2 2 5-Methoxy-N,N-diisopropyitryptarnine 5 0 2 2 Acetvl-alpha-methyjfentanyi 2 2 2 2 2 Acetyldihvdrocodeine 21 2 2 2 2 Acetyimethadol 2 2 2 2 2 2 Aliylprodine 2 2 2 2 Alphacetylmethadol 2 2 2 2 2 Alpha-ejhyUrypiamine 2T~ 2 2 2 2 ' Alpiiameprodine 2 2 2 2 Alphamethadof 2 2 2 2 Alpha-methylfenlanyl __ 2 2 2 2 2 Alpha-methylthblentanyl j 2 2 2 2 2 Alpha-methyltryptamine (AMT) 0 2 2 2 2 Aniiiiorex 2 2 2 2 2 Benzylmorphire 2 2 2 2 2 Betacetylmetliadol 2 2 2 2 2 Beta-hydroxy-3-rnethylfentanyi 2 2 2 2 2 Beta-hydroxyfentanyl . . 2 2 2 2 2 Betameprodine '2 2 2 2 2 Betamethadol 2 2 2 2 2 2 2 2 2 2 Bufolenirie . 3 3 3 3 3 Cathjnpne 3 3 4 4 4 Codaine-N-Qxide 602 602 602 602 602 Dielhyltryptamine 2 2 2 2 2 50 Difenoxin 3,000 3,000 3,000 50 Dihydromorphine 3,132,000 3.608,000 . 3,608,000 3.608,000 • 3,608,000 Dimethyltryptamine 3 3 7 ; 7 7 Gamma-hydroxybutyric acid 24,200,000 52,156,000 3,000,0001 5,772,000 29,000,000 20 20 Heroin 20 20 20 Hydromorphinol 2 2 2 2 2 Hydroxypathidine 2 2 2 "2 Ibogaine, 1 1 5 S 5 16 Lysergic Acid Diethylamide 10 15 16 16 21.000 Marihuana 4,500,000 21,000 21,000 21,000 Mescaline 7 5 5 5 5 Methaquaione ' 5 7 10 10 10 4 4 Melhcathinone 4 4 4 Methyldihydromorphine 2 2 2 2 2 Mofphine-N-oxide 605 605 60S 605 605 N-Ben2ylpiperazi"iie 2 2 2 2 2 M.N-Dimetbytampbetamine _ _ 7 2 2 2 2 N-Eihyiamphetamine 2 2 2 2 2 2 N-Hvdroxv-3.4-Melhvlenedioxvamphetamirie 2 2 2 2 Page 1 Vol. I Page 475 Aggregate Production Quotas (all values are In grams unless indicated otherwise) Final Revisedj Proposed Controlled Substance Final Revised Final Revised Initial : Initial "2010 2011 "2011 2012 Schedule): 2009 2 2 2 Noracymethadol 2 2 52 52 52 52 Nortevorphanol 52 2 2 "2 2 Normethadone 18 18 18 Normorjjhirie 16 16 2 2 2 Para-fluorofenlanyl 2 2 2 2 Phenomorphan _ 2 2 2 2 2 Phqlcodjne 2 2 . -2 2 Psilocybin _ 7 2 2 ....J 2 2 2 Psjlocyn_ 7 2 312,500 264.000 393,000 393,000 393,000 :n rocannabinols "2 2 2 Thiofentanyl 2 2 Tiiidine 1 . 0 10 10 10 10 2 Trimeperidine 2 2 Proposed Controlled Substance Final Revised Final Revised Initial Final Revised Initial 2010 2011 2012 Schedule]!: 2009 2011 2 2 1 -Phenyjcyclohexylamine 2 2 2 2 l-Piperdinocyclohexanecarbonitrile 2 0 2 2 4-Ani1ino-N-pher,ethyl-4-piperidirie (ANPP) 0 1,100,000 2,500,000 1,800,000 "1.800,0QQ 12,800 Alfentanll _ 8,000 8,000 8.000 11,60,0 Sphaprodine _ 2 2 2 2 2 40.007 40,007 Amobarbital , 3 3 40,007 Amphetamine (for conversion) 7,5_00,0p0 7.500,0001 • 7,500,000 6, 500.000 ! 81500,000 Amphetamine (for sale) 17,000.p0"6 18.600,0001 "18.600,000 25,300.0001 "25,300,000 Carfentaml 0 200 0 0 0 Cocaine 247,000 247.000 _ 247.000] 216,000 216,000 Codeine (for conversion) " 65,000,000! 65,000,000 "65,000.000 65,000.000 65,000,000 Codeine (for sale) 39^605,0001' " 39,605,000 39,605.000| 39,605.000] 39,605,000 : Dextroprepoxyphene" 106,000,000 1 92,000,000 92,000.000 7 7 Dihydrocodeine 1,200,000 600,000 600,000 255,000i 255,000 Diphenoxylate 947.000 827,000 827,000 730,000 500,000 Ecgonine 83,000 83,000 83.000 83.000 83,000 Ethylmorphine 2 2 ~2 2 2 Fentanyl 1,428.000 1,426.000 1.428,000 1.428.000 1,428,000 Glutethimide 2 2 2 2 2 Hydrocodone (for sale) 55,500.000 55.000.000 55,000,000 59,000,000, 59,000,000 Hydromorphone 3,340,000 3,455,000 3,455,000 3,455,000 3,455,000 Isomethadone 2 11 11 2 4 Levo-alphacetylmethadoi (LAAM) 3 3 3 3 3 Levomelhorphan ~ 5 5 S 2 2 Levorpharol 10,000 10,000 10,000' 3.600 3.600 Usdexamfetamine 8.200.000 9,000,000 9,000,000' 10,400,OOP1 10,400,000 Meperidine , 8,600,000 6,600,000 6,600,000 5,500,000! 5,200,000 Meperidine Intermed'iate-A 3 3 3 3 3 Meperidine Intermediate-B 7 7 7 7 7 Meperidine Intermediale-G 3 3 3 3 3 Metazocine 1 1 5 5 5 Methadone (for sale) 25.~0b0.000 20,000,000 20.000,000" 20,000,000 20,000,000 Methadone Intermediate 26.000,000 26,000,000 26,000,000 26,000,000 26,000,000 Methamphetamine 3,130,000 3,130,000 3,130.000 3,130,000 3.130,000 ' levo^desoxvephedrlne 680,000 750,000 750,000 _ 750,000 750,000 methamphetamine (for conversion) 2,405,000 2,331.000 2.331.000 2,331,000 2,_331,000 methamphetamine (for sale) _ 45,000 49,000 49,000 49.000 49,000 Methylphenidate 50,000,000 50,000,000 50,000,000 56.000.000 56,000,000 Morphine (for conversion) 100,000,000 83,000,000 83,000.000 7Q!000.Q00~ 83,000,000 Morphine (for sate) 36,300,000, 39.000,000 39,000,000 39,000,000 39.000,000 __ 10,502 Nabilone 9,002 9,002 10,502 10.502 Noroxymorphone (for conversion) 9,000,000 9,000,000 9,000,000 7,200,000 7,200,000 10,0001 41.000 401,000 401,000 401,000 Noroxymorphone (for sale) i Opium (powdered) 230.0001 230,000 230,000 63,000 63,000 Opium (tincture) 1 ,250,000 1 1,500,000 1,500,000 1,000,000 1,000,000 Oripavine 15,000.000 15,000,000 15,000,000 6,000.000 8,000,000 Oxycodone (forconversion) 4,500.000 5,600,000 5,600,000 5,600,000 5J500.000 Oxycodone (for sale) 94.obo;boo 105,500,000 105.500,000 98.0Q0.000i 98,000.000 Page 2 Vol. I Page 476 Aggregate Production Quotas (all values are in grams unless indicated otherwise) Controlled Substance Final Revised Final Revised Initial Final Revised Proposed Initial I- — Schedule II: 2009 2010 2011 "2011 2012 Oxyrnorphone (for conversion)... . . _ ; 12.g00.0p0 12,800^000 12,a00,000| 12,600,000 12,800,000 Oxymorphone (for sale) 2,570,000 3,070,000 3,070,000 3,070,000 . 5,500,000 Pentobarbital 28,000, OOP 28,000,000 28.000,000 34,000,000 31 .000.000 Phenazocine i' 1 5 5, 5 Phencyclidine _ 20 14 24 24 24 Phenmelrazire 2 2 2 2 2 Phenylacetone 250,001 12,500,001 8,000,000 8,000,000 8,000,000 Ra^roetogij^an 2 2 2 2 2 Remifentanil . . . _ 500 2,500 _ 2JM 2,500 2,500 Secobarbital 67.000 .... 67,000 260,002 336,002 336,002 Sufentanil_ 10,300 7,000 7,000 5,000 5,000 TapentadoJ . ... _ 0 1,000.000| 1,000,000 403,0001 243,000 Thebaine _ _ 126,000.000 126,000,OOP 126,000,000 116,000,OOOF 116,000,000 Page 3 Vol. I Page 477 Billing Code 4410-09-P DEPARTMENT OF JUSTICE Drug Enforcement Administration [Docket No. DEA-358P] Controlled Substances: Proposed Aggregate Production Quotas for 2012 AGENCY: Drug Enforcement Administration (DEA), Department of Justice. ACTION: Notice with request for comment. SUMMARY: This notice proposes initial year 2012 aggregate production quotas for controlled substances in Schedules I and II of the Controlled Substances Act (CSA). DATES: Electronic comments must be submitted and written comments must be postmarked on or before [INSERT 30 DAYS FROM DATE OF PUBLICATION]. 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- 358" on all electronic and written correspondence. DEA encourages that all comments be submitted electronically through http://www.regulations.gov using the electronic comment form provided on that site. An electronic copy of this document is also available at the http://www.reguiations.gov website for easy reference. Paper comments that duplicate the electronic submission are not necessary as all comments submitted to www.regulations.gov will be posted for public review and are part of the official docket record. Written comments submitted via regular or express mail should be sent to the Drug Enforcement Administration, Attention: DEA Federal Register Representative/ODL, 8701 Morrissette Drive, Springfield, VA 1 Vol. I Page 478 22152. FOR FURTHER INFORMATION CONTACT: Christine A. Sannerud, Ph.D., Chief, UN Reporting and Quota Section, Drug Enforcement Administration, 8701 Momssette Drive, Springfield, VA 22152, Telephone: (202) 307-7184. SUPPLEMENTARY INFORMATION: Posting of Public Comments Please note that all comments received are considered part of the public record and made available for public inspection online at http://www.regulations.gov and in the DEA's public docket. Such information includes personal identifying information (such as your name, address, etc.) voluntarily submitted by the commenter. 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 posted online or made available in the public docket, 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 posted online or made available in the public docket in the first paragraph of your comment and identify what information you want redacted. If you want to submit confidential business information as part of your comment, but do not want it to be posted online or made available in the public docket, you must include the phrase "CONFIDENTIAL BUSINESS INFORMATION" in the first paragraph of your comment. You must also prominently identify 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 posted online or made available in the public docket. 2 Vol. I Page 479 Personal identifying information and confidential business information identified and located as set forth above will be redacted, and the comment, in redacted form, will be posted online and placed in the DEA's public docket file. Please note that the Freedom of Information Act applies to all comments received. If you wish to inspect the agency's public docket file in person by appointment, please see the "For Further Information" paragraph. Background Section 306 of the CSA(21 U.S.C. 826) requires that the Attorney General establish aggregate production quotas for each basic class of controlled substance listed in Schedules I and II. This responsibility has been delegated to the Administrator of the DEA by 28 CFR 0.100. The proposed year 20 1 2 aggregate production quotas represent those quantities of Schedule I and II controlled substances that may be produced in the United States in 2012 to provide adequate supplies of each substance 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 do not include imports of controlled substances for use in industrial processes. In determining the proposed 2012 aggregate production quotas, the DEA has taken into account the criteria that DEA is required to consider in accordance with 21 U.S.C. 826(a) and 21 CFR 1303.11. DEA proposes the aggregate production quotas for 2012 by considering (1) total net disposal of the class by all manufacturers during the current and two preceding years; (2) trends in the national rate of net disposal of the class; (3) total actual (or estimated) inventories of the class and of all substances manufactured from the class, and trends in inventory accumulation; (4) projected demand for such class as indicated by procurement quotas requested pursuant to 21 CFR 1303.12; and (5) other factors affecting the medical, scientific, research, and 3 Vol. I Page 480 industrial needs in the United States, lawful export requirements, and reserve stocks, as the Administrator finds relevant. Other factors DEA considered include product development requirements of both bulk and finished dosage form manufacturers, and other pertinent information. The Administrator, therefore, proposes that the year 2012 aggregate production quotas for the following Schedule I and II controlled substances, expressed in grams of anhydrous acid or base, be established as follows: Basic Class - Schedule I . Proposed 2012 Quotas l-[2-(4-MorphoIinyl)ethyl]-3-(l-naphthoyl)indole (JWH-200) 45 g 1 -Butyl-3-( l-naphthoyl)indole (JWH-073) 45 g l-Methyl-4-phenyl-4-propionoxypiperidine 2g 1 -Pentyl-3-( 1 -naphthoyl)indole (JWH-Q 1 8) 45 g 2,5-Dimethoxyamphetamine is 2,5-Dimethoxy-4-ethyIamphetamine (POET) i£ 2,5-Dimethoxy-4-n-propylthiophenethylamine il 3-Methylfentanyl iS 3-Methylthiofentanyl il 3 ,4-Methylenedioxyamphetamine (MPA) 22 _g 3,4-Methylenedioxy-N-ethylamphetamine (MDEA) 15g 3,4-MethyIenedioxymethamphetamine(MDMA) 221 3,4,5-Trimethoxyamphetamine is 4-Bromo-2,5-dimethoxyamphetamine (DOB) ii 4-Bromo-2,5-dimethoxyphenethylamine (2-CB) 4-Methoxyamphetamine 77 s 4-Methylaminorex ig 4-Methyl-2,5-dimethoxyamphetamine (DOM) iS 5-(l,l-Dimethylheptyl)-2-[(lR,3S)-3-hydroxycyclohexyl]-phenol 68 g 5-(l,l-Dimethyloctyl)-2-[(lR,3S)-3-hydroxycyclohexyl]-phenol 53 g 5-Methoxy-3,4-methylenedioxyamphetamine i£ 5-Methoxy-N,N-diisopropyltryptamine is. Acetyl-alpha-methylfentanyl il Acetyldihydrocodeine ii. Acetylmethadol is Allylprodine Alphacetylmethadol is Alpha-ethyltryptamine igj 4 Vol. I Page 481 Alphameprodine Is Alphamethadol Is Alpha-methylfentanyl IS Alpha-methylthiofentanyl Is Alpha-methyltryptamine (AMT) Is Aminorex Is Benzylmorphine IS Betacetylmethadol Is Beta-hydroxy-3-methylfentanyl IS Bela-hydroxyfentanyl IS Betameprodine lg_ Betamethadoi IS Betaprodine IS Bufotenine Is Cathinone ±S / Codeine-N-oxide 602 g Diethyltryptamine Is Difenoxin 50 g Dihydromorphine 3,608,000 g DimethyLtryptamine IS Gamma-hydroxybutyric acid 29,000,000 g Heroin 20 g Ilydromorphinol IS Hydroxypethidine IS Ibogaine Lysergic acid diethylamide (LSD) 16 g Marihuana 21,000 g Mescaline Is Methaqualone Us Methcathinone 4g Methyldihydromorphine IS Morphine-N-oxide 605 g N-Bcnzylpiperazihe Is N,N-Dimethylamphetamine Is N-Ethylamphetamine 2.g N-Hydroxy-3,4-methylenedioxyamphetamine IS Noracymethadol ' 2 g Norlevorphanol 52jL Normethadone Is Normorphine 18 g Para-fluorofentanyl Is Phenomorphan Is Pholcodine Is 5 Vol. I Page 482 Psilocybin la Psilocyn il Tetrahydrocannabinols 393,000 g Thiofentanyl la Tilidine 10£. Trimeperidine la Basic Class - Schedule II Proposed 2012 Quotas 1-Phenylcyclohexylamine la 1-piperdinocyclohexanecarbonitrile la. 4-Anilino-N-phenethyl-4-piperidine (ANPP) 1,800,000 g Alfentanil 1 1,600 g Alphaprodine ls_ Amobarbital 40,007 g Amphetamine (for conversion) 8,500,000 g Amphetamine (for sale) 25,300,000 g Cocaine 216,000 g Codeine (for conversion) 65,000,000 g Codeine (for sale) 39,605,000 g Dcxtropropoxyphene la Dihydrocodeine 255,000 g Diphenoxylate 500,000 g Ecgonine 83,000 g Ethylmorphine la Fentanyl 1,428,000 g Glutethimide la Hydrocodone (for sale) 59,000,000 g Hydromorphone 3,455,000 g Isomethadone la Levo-alphacetylmethadol (LAAM) la Levomethorphan la Levorphanol 3,600 g Lisdexamfetamine 1 0,400,000 g Meperidine 5,200,000 g Meperidine Intermediate-A la Meperidine Intermediate-B la Meperidine Intermediate-C la Metazocine la Methadone (for sale) 20,000,000 g Methadone Intermediate 26,000,000 g Methamphetamine 3,130,000 g [750,000 grams of levo-desoxyephedrine for use in a non-controlled, 6 Vol. I Page 483 non-prescription product; 2,33 1 ,000 grams for methamphetamine mostly for conversion to a schedule III product; and 49,000 grams for methamphetaminc (for sale)] Methylphenidate 56,000,000 g Morphine (for conversion) 83,000,000 g Morphine (for sale) 39,000,000 g Nabilone 10,502 g Noroxymorphone (for conversion) 7,200,000 g Noroxymorphone (for sale) 401,000 g Opium (powder) 63,000 g Opium (tincture) 1,000,000 b Oripavine 9,800,000 g Oxycodone (for conversion) 5,600,000 g Oxycodone (for sale) 98,000,000 g Oxymorphone (for conversion) 12,800,000 g Oxymorphone (for sale) 5,500,000 g Pentobarbital 31,000,000 g Phenazocine la Phencyclidine 24g Phenmetrazine lA Phenylacetone 8,000,000 g Racemethorphan 2g Remifentanil 2,500 g Secobarbital ' 336,002 g Sufentanil 5,000 g Tapentadol 243,000 g Thebaine 1 16,000,000 g The Administrator further proposes that aggregate production quotas for all other Schedule I and II controlled substances included in 21 CFR 1308.1 1 and 1308.12 be established at zero. Pursuant to 21 CFR 1303.13, upon consideration of the relevant factors, the Administrator of the DEA may adjust the 2012 aggregate production quotas as needed. Comments Pursuant to 21 CFR 1303.1 1, any interested person may submit written comments on or objections to these proposed determinations. Based on comments received in response to this Notice, the Administrator may hold a public hearing on one or more issues raised. In the event l Vol. I Page 484 the Administrator decides in her sole discretion to hold such a hearing, the Administrator will publish a notice of any . such hearing in the Federal Register. After consideration of any comments and after a hearing, if one is held, the Administrator will publish in the Federal Register a final order determining the 20 1 2 aggregate production quota for the basic class of controlled substance. Dated: Michele M-. Leonhart Administrator 8 Vol. I Page 485 OC: OD: OD/D: ODX:J ODXS: CC: CCR: ODW: ODO:CAS ODEQfb><6> S:\ODE\Fed Reg\2012 Proposed Aggregate Production Quota Webcims # ODE-1 1- 9 Vol. I Page 486 ) ) ) DEPARTMENT Op JUSTICE DRUG ENFORCEMENT ADMINISTRATION, OFFICE OF DIVERSION CONTROL ARCOS 3 - REPORT TOP 35 DRUG SELLERS BY DRUG CODE Date; Business Activity: MANUFACTURER ® Orug Mams: M£THAOONE(B2£oej Sute: Zip; TraftMction Yean 2011 >2011 Division I Offioe Name: ALL OivWofiS t ALL Offices Report By; Tclal Grams Display Limit AS EL/slnesi Drug Sellers Sellers Division Office 1 MANUFACTURER® MLTKAQQNL(B2S00) (b)(4)i(b (b)(4) 40 st.lojis ST LOUIS 10.265,821.256 10,741,796 3,436,241 2 MANUFACTURER® WETHADONEP2SOB) )(7)(E) rfY NEW YORK ALBANY 8.873.63629 3 MANUFACTURER® METHAOONEP2SOO) X DETROIT COLUMBUS 4.899. 178.82 * MANUFACTURER® M£THADONE<8250G] IA WASlONGfCN DC RICHMOND 3.836,302.487 4,835,201 1,463.006 5 MANUFACTURER® M£THAIX»»(9Z50tJ) 4J NEW JERSEY CAMDEN 2,153,665.454 1.369,609 87S.78S S MANUFACTURER® METHADCNE(S2£Oft) T- MlAMI TAMPA 2.066.O4S.M 7 MANUFACTURER® MLT HADONE(S250&) JY NEW YORK ALBANY 333.189.93 6 MANUFACTURER® methadone(92S0B| gy NEW YORK N£W YORK 169.398.46 : 9 MANUFACTURER® METHAOO**(92SO0j JJ NEW JERSEY NEWARK 24.fi58.98 10 MANUFACTURER® M £ THAQONe<02SOej JN CHICAGO MINNEAPOLIS H.32?.7l 11 MANUFACTURER® METHADONE(92503) >C ATLANTA COLUMBIA 5,078.78 12 MANUFACTURER® METHADONE(92509) JC ATLANTA GREENSBORO 4.972.32 13 MANUFAC JUfl ER® METMAQONE(B2Stl6j 3K DALLAS OKLAHOMA CITY 3.268.34 14 MANUFACTURER® METMADONE(52SOej :o DENVER DENVER 3.173.41 16 MANUFACTURER® METMADON£ce25O0] SA ATLANTA ATLANTA 1 ,897.03 16 MANUFACTURER® METHAQONE IT manufacturer® M£TKAOCW£(925O0) rx HOUSTON HOUSTON 1.087.66 I 18 MANUFACTURER® UETHADONE C9250BJ UA BOSTON 9OSTON 1.0fi5.t5 19 MANUFACTURER® METHAOONE(92SOG1 AH CHICAGO MINNEAPOLIS 920.33 i 20 MANUFACTURER® UETHAOONE(G25O0) 4A BOSTON BOSTON 894.40 > 21 MANUFACTURER® M£THAOONE(93SOBJ 3H DETROIT DETROIT 775.57 » 22 MANUFACTURER® MCTHADONE(02SCe) JA BOSTON BOSTON 511. SB I 23 MANUFACTURER® METHADON Et925Cej 3A ATLANTA ATLANTA 4«i,2i r 24 MANUFACTURER® METHADONE(92506] rN ATLANTA KNOKV1LLE 345 03 i 25 MANUFACTURER® METHADONEC92M6J OALLAS TULSA 237 47 2 estimated 2012 PQ - estimated 7012 MQ quantity of methadone intermediate PQ Summary 16.498.865.937 32.997,731.874 32,516,070.414 required for PQ aiy) PQ inventory Manufactured Inventory inventory allowance ]30%) inve ntory a I Iowa nee ( 30%] 52,763,373.267 MQ Summary 16.2S 8, 010.207 17,426,606 5,778,035 42,897,051-436 42,270,826.533 required for MQ only 39,9W,70S.109 Vol. I Page 487 ) ) ) DEPARTMENT OP JUSTICE DRUG ENFORCEMENT ADMINISTRATION, OFFICE OF DIVERSION CONTROL ARC03 3 -REPORT TOP 25 DRUG SELLERS BY DRUG CODE Dale: a;i&7Di2 Builrwit Activity: MANUFACTURER Drug Nirra; M£THADONE(92SOG) Staio; Zip: Tratmction Year: 2012-2012 Division I Office Nimer ALL Divisions / ALL Offices Report By: Jota) Grams Dttpliy Limit: 25 Huskies* Drug Seller's Sailer's Division Office Rank Activity Nfcm* Ooa No Name City Stale Name Name Total Grams Last Report i MANUFACTURER^ METKADQN£ 3 MANUFACTURER(E) METHADONE(925QB) VA WASHINGTON DC RICHMOND 3.401.650.162 Bulk Manufacturer 30-iun MANUFACTURERIE) fAETHADONE(925CB| OH DETROIT COLUMBUS 3,138,499.3* 5 MANUFACTURER^ MCTHAOO«E 7 MANUFACTURER^ METHADONE1925CB) NY NEW YORK NEW YORK 159,896.662 8 MANUFACTURERS METHADONE19250B) NY NEWYORK ALBANY 1W.930.07t 9 MANUFACTURER^) ME7HAD0NE^92509) NJ NEW JERSEY NEWARK 2 B, 97S 5« 10 manufacturer(E) METHAOONE192SOB) sc ATLANTA COLUMBIA 6.203. 535 11 MANUFACTURE R(E) METHADONE(9?S0B) NC ATLANTA GREENSBORO 5,061.052 12 MANUFACTURER^ METHADONE(92SOB) OK DALLAS OKLAHOMA CITY 1,604.S5« 13 MANUFACiURERfE) METHADONEt925O0) CO DENVER DENVER l,409.6Ct 14 MANUFACTURERIE) METHADOflF 15 MANUFACTURERS) METHADONE(9250S5 GA ATLANTA ATLANTA 1.051.601 16 MANUFACTURERS) M£THADONE(925C0) TX HOUSTON HOUSTON 727.147 17 MANUFACTURERS METHAOONE(92509) UN CHICAGO M NNEAFOUS 694.945 16 MANUFACTURERS) METHADON £(92503) MA BOSTON BOSTON 656.95* 19 MANUFACTURER(E) METKADONE(fl2503) AL NEWORLEANS M0S3LE 556.317 26 MANUFACTURE R(5) METHADONE(g25QB) OH DETROIT DETROIT 423.337 21 MANUFACTURER(E) METHADONEt82508j IL CHICAGO CHICAGO 31 D.969 22 MANUFACTURER^ METMADON £(92503) NJ NEW JERSEY NEWARK 289 973 23 . MANUFACTURER^) METKAOONE(92509) CA LOS ANGELES LOS ANGELES 96.729 24 MANUFACTURER^) M£THAOON£(92SOB) MA BOSTON BOSTON 91.955 25 MANUFACTURER(E) METHAOON E<92MB) MS NEW ORLEANS NEWORLEANS 62.963 estimated 2012 PQ estimated 2012 MQ quantity of methadone intermediate PQ Sumnnty( 8,783,675.56^ 17,567,3S1.120 24,362,664.560 required for PQand PQ inventory Inventory allowance [303iJ inventory allowance 130%) 28,090.194.441 MQ Summ»ry| 12,181.333.284 22,837.555-455 31,571,463-928 required for MQ only 29,966,077.4 G9 1 -i J • • j- / Vol. I Page 488 ) J- S ) DEPARTMENT OF JUSTICE ORUO ENFORCEMENT ADMINISTRATION, OFFICE OF DIVERSION CONTROL AHCOS J- REPORT TOP 25 DWG SELLERS 8Y CRUO CODE Date: 6/W2012 Bu»lne«J Activity: MANUFACTURER (6) Drtifl Name: M£THAOON£(92SOB} State: Zip; Transaction Year 2012-2012 Division / Office Name: ALL Divisions / ALL Qlfice* Report By; Total Grams Display Limit: 25 Bvsirtoai On*g Seller's Seller*! Division Office RanV Activity Name Dca No Name City $t«« Narao Nan* Total Gramfl Last Report 1 MANUFACTURER(E) METHAQQNE<9250H) (b)(4)i(b) (b)(4) AO ST. LOUIS" ST LOUIS 7,477,1 as^sa Bulk Manufacturer 30-iun 2 MANUFACTURER® METHACONE(92$OB) (7)(E) <1 NEWYORK ALBANY 3.972.349 S94 3 MANUFACTURERS) METHAD0NE(9250S) /A WASHINGTON DC RICHMOND 3,4Ci.6S0.te2 Bulk Manufacturer 30-Jun 4 MANUFACTURER® METHADONE<<*2SOB) DH OETROiT COLUMBUS 3,1&3.499.3G5 5 MANUFACTURER® METHADONE(92508) 4J NEW JERSEY CAMDEN 1.302,496.032 Bulk Manufacturer 30-iun 6 MANUFACTURER® METHADONE{92S06) L MIAMI TAMPA 1.276,453.316 7 MANUFACTURER® METMACONE(9250B) *IY NEWYORK NEW YORK 159.696 662 6 MANUFACTURER^) M6THAD0NE(925CB) TY NEWYORK ALBANY 134,930078 9 MANUFACTURER® METHAD0NE(92SO9) VJ NEW JERSEY NEWARK 23,979.560 10 MANUFACTURER® METHADON£(9250B) SC ATLANTA COLUMBIA 6.203.535 11 MANUFACTURER® METHADONE(9250B) *3 ATLANTA GREENS0ORO 5,061.052 12 MANUFACTURER® METHADONE (9250B) 3K DALLAS OKLAHOMA CITY 1.604.554 13 MANUFACTURER® METHAD0NE19250S) ZO OENV/ER DENVER 1.406 600 14 MANUFACTURER® METHADONE!(92SOB) m ATLANTA KNOXV1LLE 1.326.&42 15 MANUFACTURER® M£THADONE(92SOB) 3A ATLANTA ATLANTA 1.051.801 16 MANUFACTURER® METHA0QNE(925Qe> FX HOUSTON HOUSTON 727.147 17 MANUFACTURERS) METMAOONE{92SOB) m CH;CAGO MINNEAPOLIS 694.949 18 MANUFACTURERS) METHADONE(92SOB> BOSTON BOSTON 656.954 19 MANUFACTUR £R(E) METKAOONEC92506) 4L NEW ORLEANS MOBILE 556.317 20 MANUFACTURER® METHADONE1925CB) OH DETROIT DETROIT 423.337 21 MANUFACTURER® METHAOONE (92508} L CH'CAGO CHICAGO 310.965 22 MANUFACTURER® M£THADONE(92S08) UJ NEW JERSEY NEWARK 289.973 23 MANUFACTURER® METHAOONE(925CB) CA LOS ANGELES LOS ANGELES 9G.729 24 MANUFACTURER® METHAf>DNE{925CB) UA BOSTON BOSTON 91.955 25 MANUFACTURER® METHADONE(92SCB) MS New ORLEANS NEW OR LEANS 62.963 [ pq Summary."! 6, 763,675. S6t?) / / \ —> •• :>y" u\/s r> / / — > : | HQ Summary} 12,161.312.280] ^ 2- r \ "Z - s r ) :y. - 5 o J h I i t « > j Vol. I Page 489 ) ) ) :>? O 1 department of jusnet ORuG ENFORCEMENT AOMtfJlST RATON. OFFICE OF WERStQN CONTROL ARCOS3 * REPORT TOP li OROO SELLERS flY DRUG CODE D«»! 6/1CV2012 ' Bufltmi Activity: MANUFACTURER ® Otuq Name; UtTMADONE(0i60B) Sue*: Zip: TrantactrQn YeiC 2011 - JCll ONisiofl 1 Office Name: ALL ONiStoiH / ALL OHiceS Report 0/: Tolal Grams OitpMy UmrL 24 Business Drug Setter* Sertif"! DlviSlcr office Quantity RioV Activity Name Dee No Name [City Slit# Nur-e Name Total Grams manufactured In 20 IT | 2010 Inventory MANUFACTURER® vEMADGHefVioe) (b)(4)i(b (b)(4) WO ST. LOUIS ST LOUIS 10,»S,&1.2S6 10,741,796 3,436,241 2 IMANUFACTURER® M£TMADONE(93SOej )(7)(E) NY NEW YORK ALBANY 6.073.63629 3 IMANUFACTURER® METHADONE(92SQ6) OK DETROIT COLUVBUS A.BB5.1J8.S2 MANUFACTURER® NETHADONFP»Oer MA WASHINGTON DC RICHMOND 3.630.302.497 4,815,201 1,463,006 3 [manufacturer® • N£THADONE(92SG9) Ml NEW JERSEY CAAtOEN 2,153.680 454 1,869,609 878,788 S IMANUFACTURER® METHADONE(92SC6) FL MIAMJ TAMPA 2.06S.WS03 7 |MANUFACTURER® METHADONE(925CSJ NY NEW YORK ALBANY 133,1 aa 03 6 iMANUFACTURER® METMADONE(32SCe) NY MEWYORX NEW YORK 189,398.46 9 iMANUFACTURER® METHADONE<92500) NJ NEW JERSEY NEWARK 3t,auM \1 MANUFACTURER® METHADONE(1^2506) UN CHICAGO MINNEAPOLIS 6.327.71 11 MANUFACTURER® METHAOON6(»2««) SC ATLANTA COLUMBIA 5.078.761 17 [MANUFACTURER® METHADONE(92500) NC ATLANTA GREENSBORO 4.972.32 13 (MANUFACTURER® METHADONE®*®) OK OALLA5 OKLAHOMA CITY 3.266.34 [MANUFACTURER® METHADONE®500) CO DENVER DENVER 3,173.41 IS MANUFACTURER® METHADONE®500) GA ATLANTA ATLANTA 1,887.8: IS 'MANUFACTURER® METHADONE^**) AL NEW ORLEANS U03ILE 1,343.44 *7 IMANUFACTURER® «£THACONE(92S06) T* HOUSTON HOUSTON 1.047.68 14 MANUFACTURER® METHADONE(92506) MA BOSTON BOSTON 1.044.15 I 19 MANUFACTURER® METHADONE(92506) MN CHICAGO MINNEAPOLIS 02033 I 20 MANUFACTURE*!® METHACCftE(92506) MA BOSTON BOSTON 594.40 I 21 [manufacturer® METHaCONE{92506) OK DETROIT DETROIT "77537) 22 [manufacturer® METHADONE(924Ce) MA BOSTON BOSTON 511.55 > 23 MANUFACTURER® MEYHADON£(®25Ce) GA ATLANTA ATLANTA 441.21 24 [MANUFACTURER® METMADONE(92MO) TN ATLANTA KNOKVUJ1 345.03 I 25 [MANUFACTURER® METHAOON£(92SCfi) OK . DALLAS TULSA 237.47 1 PQ Summary 1649B.SCS.937 Manufactured Inventory MQ. Summary 16.258,010-207 17,426,606 5,776,035 Vol. I Page 490 I ( ( S S 2 S S S 5 S S t 8 S il S S S S S S i S S ! S i 5 5 S S ; 5[a -|S|,°' : s I ! i 1 1 1 1 1 1 i I ! 1 1 ! 1 1 1 1 1 1 1 1 i i 1 1 i 1 1 i I i i § 1 1 ! s s i I SlMfflfl 1 1 * (- fiBaRBSSSBfiRSSSSSSSSllsfiSBfiBSSSBSSasSfiSaSRaR 8 | 2 s S « s f | llllillil!iiiii!liiiiiii!iii§!li!!!!ll!!!l I I" 1 1 1 1 1 1 j»siias»s»a43ss«a8ii3a335i3a®9ss«E5saaass«ss(B 3 S ' 5 § 1 1 1 ! $ I ! I! 1 1 1 1 1 ! ! I ! 1 1 1 1 1 1 1 1 1 1 1 i i f J 1 1 1 1 1 f a J J f ? 3b I § S3? I B | SfsgsSS? a tS I1 gs Ss § $rl }i2i- s52 I rr * lis! 8 S s 0 * * > II § £ I f § I sll| f Is I I ill § s Sis SISifa 3 3 TJ 0) S "Is ca § -o CD °s s1 4^ CD JI f a»i >ui gi -I ai *r ai ki sr8i $i 8! yi gj gi gi yi #i si pi gi *i gi 21 §1 31 &| *1 81 sis s|9|8|3|a|g|8|?|gie|5 |*p? Ssasss|isiI5i5l5isss-8sssssssss 5 S 5 2 S S 5_ §. 8_ So2|33ofC||i-gg>>^g>|>>|>>v|a| E » 5 C*\ lilli?§ § § "5 g g 1 " 1 " 1 1 " ? * P § 0 M B § a | a a a 1 § > |!"H f'i 1 fo m In i S i jq n «° 8 ® « 8 £ S ffi SS 3 8 v> CO Ui 000 g I!8|pi!|II>||gIll||^S8§ip|i8sg8l|||55g|| ||-| 1 1 1 P s ! ! 1 1 ! 1 1 i ! I 1 1 1 1 i ^ H 1 1 1 1 1 1 1 g § 1 § r ! " § £ 1 pgs g ppo p " PPP * P P ? P £ m I IS i s §! | IS ISISfflSSSSISSS? 5S?|0K§ JA ^ — j* v >» t* * « a t* » O) •+ 3 S S a o» c3 £! S Su> "m = 5 S&J5 silill iilllllliiiilllllil I 11 £II*_lI o o *-. < H >_ 5 Vol. I 2011 IMS Sales as base Substance 2011 c.f. base total Aifentanil 0.491 0.900 0.442 Amphetamine 20,153.177 21.664.665 Cocaine 48.516 0.890 43.179 Codeine 25,974,865 0.860 22,338.364 Dihydrocodeine 106.161 0.640 67.943 Diphenoxylate 455.692 0.930 423.794 Fentany! 536.229 1.000 " 536.229 Hydrocodone 64,813.797 0.61 Q 39,536.416 Hydromorphone 1,669.942 0.890 1,486.248 Levorphanol 0.323 1.000 0.323 Lisdexamfetamine 12,236.523 0.580 7,097.183 Meperidine 2,296.373 0.870 1,997.844 Methadone 7,621.043 0.890 6,782.729 Methamphetamine 13.645 0.800 10.916 Methyiphenldate 19,043.348 0.870 16,567.713 Morphine 30,317.864 0.750 22,738.398 Nabilone 0.058 1.000 0.058 Opium 84.217 1.000 84.217 Oxycodone 70,572.060 0.900 63,514.854 Oxymorphone 2,640.625 " 0.890 2,350.156 Pentazocine 832.885 1.000 832.885 Pentobarbital 79.042 0.910 71.928 feir . . • Remifentanil 1.044 0.910 0.950 Secobarbital 20.550 0.920 18.906 Sufentanil 0.052 0.670 0.035 Tapentador 4,996.502 0.860 4,296.992 Vol. I Page 492 O o o o P O o o O Q O o O o o O O o O V o g O o O O O o O o o o O O O D O o o a o g o o bjt 3 I 5 ° O O o a000o0PDUQCpo«oo0oo00D000aDP09g0QaeQeQeQ0O0C0 I ^i§i!!i!!||i!!!!!i!i!!!!i|!§!|!!|!|ii!!ii!i!§«i 3 3 s D "* -H .h ^ r* f IN^cn S •-» <0 K ^ ^ 1,1 "1 1/1 ® O O Oo 06B0000o0ooooo0O00 o o o o a o O OpOOqooO poooopaoooDOO 2 s I s . e o O O O oaooooooooooooooo u n O o q o O O g a ^ O q a o OOOO^O^OOOOO is m i » s s -T «N <-« ** E to Ml? i I I § S I S " 3 S I I § R I § o P C» <6* » H < IN l» (tf N rs 2 22- 53 13 53 2- 12- S1 13 C-5- I-1- 2- 11- 3 3»- 52- 1-2- S3 1f- f-1 52- 3 5 12- 1" SI- 53 I§ 3 1S 2-3 2-3 ^ ' £I ^ £ g O »* N r4 ^ pi tn m "> N ui h n n m n — ui «n r« »* m pi h h J2- 5 O CO a !!i|I§l2!iP!!|i!!i!!ii|ji!!|P!i|ii!H!ii!i!!i§?|i G3 ' "T "" to" VI to to rl ^r s V CD I 3 a> 03 I CL f IS fig u|||||||SS||||||||||5E55l§s|s|ll|sS||SSI||SIS|gS|§SS fgliiSiiSSSisiiiiiiiiiiiiiiliiilSIiilifliliilSiisii!uaaabtLD.ikaaa.B^i^aa^b.D.iKdCkUti.o.a n. b a ck O- ix a. a a % a el & a. a a. d. a. il o* co fo o AiQiO^iflionicna indiaipQidiiimaiaiaibaa] acpoaaoaaaii n o a a i& a d si (O oi cj ^ co fl) ° giflio>oi{"(A(wcicio>8>iT>St>iiiiqioiSit>oio!g!ciCTS q> S qxmo>qtq%5>qi5'qxq^5^5>q!qsqj SSSSa!»»pi! i§ l£m r-- ) I ) Vol. I hydracone 2012 PQ of pd only Pea Hum Company Quota Request Quota Allotment Comm Manuf Transfers Prod Dev Replacements Packaging (b)(4);(b)(7 [b)(4) 109,800 54,900 0 O 54,900 0 0 >(E) 575,000 575,000 0 0 575,000 0 0 s 5 0 O 5 0 0 S99.2S0 521,650 219,700 0 301,950 0 0 80,830 80,830 0 0 80,830 0 0 9,211 9,211 0 0 9,211 0 0 77,928 77,928 17,080 0 60.848 0 0 478,088 1Z9.OC0 108,000 0 21,000 0 0 101 101 0 0 101 0 0 8,693 8,693 0 0 8,693 0 O 257,030 228,673 94,756 0 133,917 0 0 157,600 153,305 153,061 0 244 0 0 49,040 49,040 0 0 1,683 0 47,357 42,000 42,000 0 0 42,000 0 c 1,700 800 0 0 goo 0 0 18,300 3,660 0 0 3,660 0 0 915 443 0 0 443 0 0 27,000 27,000 0 0 27,000 0 0 244 231 0 0 231 0 0 22,229 21,923 0 0 21,923 0 0 127,185 79,605 0 0 79.605 0 0 114,757 54,635 4S.535 0 9,100 0 0 275,113 173,000 134,000 0 „ 39,000 0 0 37,711 30,000 0 0 30,000 0 0 96,080 7S.498 0 0 79,498 0 0 13,039 12,200 0 0 12,200 0 0 2,106 2,106 0 0 2,105 0 0 60,000 60,000 0 0 Va 60,000 0 0 6,161 6 0 0 6 0 0 8,854 8,854 0 0 8,854 0 0 9,614 9,614 0 0 9,614 0 0 52,004 52,004 0 0 52,004 0 0 58,953 56,368 0 0 56,368 0 0 36,000 36,000 0 0 36,000 0 0 2,440 484 0 0 484 0 0 109,800 60,390. 0 0 60,390 0 0 335,942 249,622 37,250 0 212,372 0 0 15,258 15,257 0 0 15,257 0 0 2,149,390 714,044 693.85S 0 15,189 0 0 5,494 5,494 0 0 5,494 0 0 38,125 38,125 0 0 38,125 0 0 577,000 380,147 353,647 0 26,500 0 0 80,760 80,760 0 0 80.760 0 0 21,731 13,879,642 13,841,000 0 38,642 0 0 PD total 2,312,007 / /' Vol. I Page 494 2012 Proposed Adjusted Aggregate Production Quotas • Section 306(a) of the Controlled Substances Act (CSA) requires the Attorney General to establish limits on the production of schedules I and II controlled substances. This responsibility has since been delegated to the Administrator of the Drug Enforcement Administration (DEA). • The attached Federal Register notice, prepared for your signature, Proposed Revised Aggregate Production Quotas (APQ) for 2012 for schedules I and II controlled substances for which the United States has medical, scientific, industrial, export, and reserve stock requirements. Also attached is a list of the 2010 and 201 1 APQs for these substances for comparison. • An expedited review and publication is requested to ensure an uninterruptable supply of schedule I and II controlled substances for medical, scientific, industrial, and export requirements of the U.S. • The following points provide brief explanations of the changes from the proposed APQ values: Schedule 1 substances • The APQ for 1 l-[l-(2-ThienyI)cycIohexyl]piperidine, 2,5-Dimethoxyamphetamine, 2,5-Dimethoxy-4- ethylamphetamine (DOET), 2,5-Dimethoxy-4-n-propylthiophenethylamine, 3,4-Methylenedioxy-N- methylcathinone (methylone), 3,4-Methylenedioxy-N-ethylamphetaminc (MDEA) , 3,4- Mcthylcncdioxypyrovalcrone (MDPV), 3,4,5-Trimethoxyamphetamine, 4-Bromo-2,5- dimethoxyamphetamine (DOB), 4-Bromo-2,5-dimethoxyphenethylamine (2-CB) , 4-Methoxyamphetamine, 4-Mcthylaminorex, 4-Methyl-2,5-dimethoxyamphetamine (DOM), 4-Methyl-N-methylcathinone (mephedrone), 5-Methoxy-3,4-methylenedioxyamphetamine, 5-Methoxy-N,N-diisopropyltryptamine, Alpha- ethyltryptamine, Alpha-methyltryptamine (AMT), Aminorex, Carfentanil, Cathinone, Diethyltryptamine, Dimethyltryptamine, Mescaline, Methcathinone, N-Benzylpiperazine, N,N-Dimethylamphetamine, N- Ethylamphetamine, N-Hydroxy-3,4-methylenedioxyamphetamine were increased. The manufacturing of these substances will be used for analytical standards, reference, and research material. New DEA registrant(s) entering the reference standard market at the bulk manufacturing level. Schedule 11 substances • The APQ for alfentanil was increased due to increased exportation requirements. One DEA registrant is now the sole supplier to the European market, the registrant's European company has stopped manufacturing alfentanil products. • The APQ for 1-Piperdinocyclohexanecarbonitrile was increased. The manufacturing of this substance will be used for analytical standards, reference, and research material. New DEA registrant(s) entering the reference standard market at the bulk manufacturing level. • The APQ for amphetamine (for sale), hydrocodone (for sale), hydromorphone, oxycodone (for sale), and opium powder were increased due to increased sales. Amphetamine (for sale) manufacturing has high losses due to the isomer isolation, i.e., d-amphetamine from the racemic (d, l-amphetamine) mixture. DEA registered bulk manufacturers of these substances were justified by sales and customer procurement quotas but limited by the current APQ in the quantity of quota they received. • The APQ for noroxymorphone (for sale) was increased due to increased sales and FDA validation and launch requirements. One DEA registrant is the sole supplier of a product that is under FDA review, the material is required for clinical trials which are being conducted in European countries. • The APQ fororipavine was increaseddue to the increased sales of the controlled substances that utilize oripavine as the starting material. These controlled substances include; hydromorphone, oxymorphone, noroxymorphone, and the "nal" drugs. ODQ 06-04-2012 Vol. I Page 495 Aggregate Production Quota Changes (all values are In grams unless indicated otherwise) Controlled Substance Final Revised Initial Final Established Proposed Revised Schedule I: 2010 2011 2011 2012 2012 2,5-Dirnethoxyamprietamine 2 2 2 2 12 2,5-Dimethoxy-4-Ethylamphetamine (DOET) 2 2 2 2 12 2,5-Oimethoxy-4-(n)-propylihiophenethylariine 0 2 2 2 12 3,4-Methylenedioxy-N-Ethylamphetamine (MDEA) 10 15 15 15 24 3,4-Methylenedioxy-N-methylcathinone (melhylone) a 12 3,4-Methyler.edioicypyrovalerone (MDPV) 8 12 3,4,5-Trimethoxyamphelamine 2 2 2 2 12 4-Bromo-2,S-Oimethoxyamphetamine (DOB) 2 2 2 2 12 4-Bromo-2,5-Dimelhoxyphenethylannine (2-CB) 2 2 2 2 12 4-Methoxyamphelamine 77 77 77 77 88 4'Methylaminorex 2 2 2 2 12 4-Methy|.2,5-Dimethoxyamphetamine (DOM) 2 2 2 2 12 4-Methyl-N-methylcathinone (mephedrone) 8 12 5-Mettioxy-3,4-Methylenedioxyamphetamine 2 2 2 2 12 5-Methoxy-N,N-dii8opropyiliyptamine 0 2 2 2 12 Alpha-ethyltryptamine 2 2 2 2 12 Alpha-methyltryptamine (AMT) 2 2 2 2 12 Amirorex 2 2 2 2 12 Cathinone 3 4 4 4 12 Dielhyltrypiamine 2 2 2 2 12 Oimethyltiyptamine 3 7 7 7 18 Mescaline 5 5 5 5 13 Meth cathinone 4 4 4 4 12 N-Serizylpiperazine 2 2 2 2 12 N.N-DimelPylamphetamine 2 2 2 2 12 N-Ethylamphetamine 2 2 2 2 12 N-Hydfoxy-3,4-Methylenedioxyamphetamine 2 2 2 2 12 Final Revised Initial Final Established Proposed 2012 Schedule II: 2010 2011 2011 2012 Allentanil 8,000 8,000 11.600 15,000 19,550 25,300,000 Amphetamine (for sale) 18,600,000 18,600,000 25,300.000 33,400,000 Carfentaml 200 0 0 0 5 Hydrocodone (for sate) 55,000,000 55,000,000 59,000,000 59,000.000 63,000,000 401.000 Noroxyrnorphone (for sale) 41,000 401,000 401,000 1,981,000 Opium (powdered) 230,000 230,000' 63.000 73,000 Oripavine 15,000,000 15,000,000 9,800.000 15,300,000 Oxycodone (for sale) 105,500,000 105,500,000 98,000,000 98,700.000 Page 1 Vol. I Page 496 Billing Code 4410-09-M DEPARTMENT OF JUSTICE Drug Enforcement Administration (Docket No. DEA-363| Controlled Substances: Proposed Adjustment to the Aggregate Production Quotas for 2012 AGENCY: Drug Enforcement Administration (DEA), Department of Justice. ACTION: Notice with request for comments. SUMMARY: This notice proposes to adjust the 2012 aggregate production quotas for several controlled substances in schedules I and II of the Controlled Substances Act (CSA). DATES: Electronic comments must be submitted and written comments must be postmarked on or before [INSERT 30 DAYS FROM DATE OF PUBLICATION]. Commentcrs 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- r 363" on all electronic and written correspondence. DEA encourages all comments be submitted electronically through http://www.regulations.gov using the electronic comment form provided on that site. An electronic copy of this document is also available at the http://www.rcgulations.gov website for easy reference. Paper comments that duplicate the electronic submission are not necessary as all comments submitted to www.regulations.gov will be posted for public review and are part of the official docket record. Should you, however, wish to submit written comments via regular or express mail, they should be sent to the Drug Enforcement Administration, Attention: DEA Federal Register Representative/ODL, 8701 1 Vol. I Page 497 Morrissette Drive, Springfield, VA 22152, FOR FURTHER INFORMATION CONTACT: John W. Partridge, Chief, Liaison and Policy Section, Drug Enforcement Administration, 8701 Morrissette Drive, Springfield, VA 22152, Telephone: (202) 307-4654. SUPPLEMENTARY INFORMATION: Posting of Public Comments Please note that all comments received are considered part of the public record and made available for public inspection online at http://www.reguIations.gov and in the DEA's public docket. Such information includes personal identifying information (such as your name, address, etc.) voluntarily submitted by the commenter. 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 posted online or made available in the public docket, 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 posted online or made available in the public docket in the first paragraph of your comment and identify what information you want redacted. If you want to submit confidential business information as part of your comment, but do not want it to be posted online or made available in the public docket, you must include the phrase "CONFIDENTIAL BUSINESS INFORMATION" in the first paragraph of your comment. You must also prominently identify 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 posted online or made available in the public docket. 2 Vol. I Page 498 Personal identifying information and confidential business information identified and located as set forth above will be redacted, and the comment, in redacted form, will be posted online and placed in the DEA's public docket file. Please note that the Freedom of Information Act applies to all comments received. If you wish to inspect the agency's public docket file in person by appointment, please see the For Further Information Contact paragraph. Background Section 306 of the CSA (21 U.S.C. 826) requires that the Attorney General establish aggregate production quotas for each basic class of controlled substance listed in schedules I and II. This responsibility has been delegated to the Administrator of the DEA by 28 CFR 0.100. The Administrator, in turn, has redelegated this function to the Deputy Administrator, pursuant to 28 CFR 0.104. The 2012 established aggregate production quotas for controlled substances in schedules I and II were published in the Federal Register (76 FR 78044) on December 15, 201 1. That notice stipulated that, as provided for in 21 CFR 1303.13, all aggregate production quotas are subject to adjustment. Analysis for Proposed Revised 2012 Aggregate Production Quotas DEA now proposes to adjust the established 2012 aggregate production quotas for some schedule I and II controlled substances. In proposing the adjustment, DEA has taken into account the criteria that DEA is required to consider in accordance with 21 CFR 1303.13. DEA proposes the adjustment of the aggregate production quotas for basic classes of schedule I and II controlled substances by considering ( I ) changes in demand for the class, changes in the national rate of net disposal for the class, and changes in the rate of net disposal by the registrants holding individual manufacturing quotas for the class; (2) whether any increased demand or changes in the national and/or individual rates of net disposal are temporary, short term, or long term; (3) 3 Vol. I Page 499 whether any increased demand can be met through existing inventories, increased individual manufacturing quotas, or increased importation without increasing the aggregate production quota; (4) whether any decreased demand will result in excessive inventory accumulation by all persons registered to handle the class; and (5) other factors affecting the medical, scientific, research, and industrial needs of the United States and lawful export requirements, as the Administrator finds relevant. In determining whether to propose adjustments to the 2012 aggregate production quotas, DEA considered updated information obtained from 201 1 year-end inventories, 201 1 disposition data submitted by quota applicants, estimates of the medical needs of the United States, product development, and other information made available to DEA after the initial aggregate production quotas had been established. The Deputy Administrator, therefore, proposes to adjust the 2012 aggregate production quotas for some schedule I and II controlled substances, expressed in grams of anhydrous acid or base, as follows: Previously Proposed Basic Class - Schedule I Established Adjusted 2012 Quotas 2012 Quotas 1 -f I -(2-Thienyl)cyclohexyl1piperidine 0£ l-[2-(4-Morpholinyl)ethyll-3-(l-naphthoyl)indolc (JWH-200) 45 g No Change l-Butyl-3-(l-naphthoyl)indole (JWH-073) 45 g No Change l-Methyl-4-phenyl-4-propionoxypiperidine 2 g No Change l-Pentyl-3-(l-naphthoyl)indole (JWH-0 1 8) 45 g No Change 2,5-Dimethoxyamphetamine 2g lis. 2.5-Dimethoxy-4-ethylamphetamine (POET) 2g IziL 2,5-Dimethoxy-4-n-propylthiophenethylamine lA Ha 3-Methylfentanyl 2 g No Change 3-Methylthiofentanyl 2S No Change 3,4-Methylenedioxyamphetamine (MDA) 22 g 30 g 3,4-Methylenedioxy-N-methylcathinone (methylone) 8* 12* 3,4-Methylenedioxy-N-ethylamphetamine (MDEA) 15 g 24 g 3,4-Methylenedioxymethamphetamine (MDMA) 22 g 30 g 3,4-Methylcncdioxypyrovalerone (MDPV) Is. 12* 4 Vol. I Page 500 3,4,5-Trimethoxyamphetamine la llA 4-Bromo-2,5-dimethoxyamphetamine (DOB) la Hi_ 4-Bromo-2,5-dimethoxyphenethylamine (2-CB) la 12* 4-Methoxyamphetamine Ha 88 g 4-Methylaminorex la Ha 4-Methyl-2,5-ditnethoxyamphetamine (DOM) 2 g I2g 4-Methyl-N-methylcathinone (mephedrone) la ila 5-( 1 ,1 -Dimethylheptyl)-2-f( I R.,3S)-3-hydroxycyclohexyl"|-phenol 68 g No Change 5-(l,l-Dimethyloctyl)-2-f(lR<3S)-3-hydroxycyclohexyl]-phenol Ha No Change 5-Mcthoxy-3,4-methylenedioxyamphetamine la ill 5-Methoxy-N,N-diisopropyltryptamine la ila Acetyl-alpha-methylfcntanyl la No Change Acetyldihydrocodeine la No Change Acetylmethadol la No Change Allylprodine la No Change Alphacctylmcthadol la No Change Alpha-ethyltryptamine la ila Alphameprodine la No Change Alphamethadol la No Change Alpha-methylfentanyl la No Change Alpha-melhylthiofentanyl la No Change Alpha-methyltryptamine (AMT) la 12g Aminorex 2 g Ha Benzylmorphine 2g No Change Bctacetylmethadol 1 la No Change Beta-hydroxy-3-methylfentanyl la No Change Beta-hydroxyfentanyl la No Change Betameprodine la No Change Betamethadol la No Change Betaprodine la No Change Bufotenine la No Change Cathinone 4 g 12 g Codeine-N-oxide 602 g No Change Diethyltryptamme la Ha Difenoxin 50 k No Change Dihydromorphine 3,608,000 g No Change Dimethyltryptamine la 1-8 g Gamma-hydroxybutyric acid 47,000,000-g No Change Heroin 20 g No Change Hydromorphinol 54 g No Change Hydroxypethidine la No Change Ibogaitie la No Change Lysergic acid diethylamide (LSD) Ha No Change 5 Vol. I Page 501 Marihuana 2 1 >000 g No Change Mescaline 5g ]3g Methaqualone IQg No Change Methcathinone 111 Methyldihydromorphine 1* No Change Morphine-N-oxide 655 g No Change N-Benzylpiperazine 1SL ±2& N,N-Dimethylamphetamine 2g |2g N-Ethylamphetamine 2g Hi N-Hydroxy-3,4-methylenedioxyamphetamine 2* Hi Noracymcthadol 2g No Change Norlevorphanol 52 g No Change Normethadone il No Change Normorphine 18 g No Change Para-fluorofentanyl Is No Change Phenomorphan 2g No Change Pholcodinc la No Change Properidine la No Change Psilocybin 2g No Change Psilocyn la No Change Tetrahydrocannabinols 393,000 g No Change Thiofentanyl No Change Tilidinc 10 g No Change Trimeperidine 2 g No Change Previously Proposed Basic Class - Schedule II Established Adjusted 2012 Quotas 2012 Quotas 1 -Phenylcyclohexylamine 2 g . No Change l-Piperdinocyclohexanecarbonitrile i! 27* 4-Anilino-N-phenethyl-4-piperidine (ANPP) 1,800,000 g No Change Alfentanil 15,000 g 1 9,550 g Alphaprodinc la No Change Amobarbital 40,007 g No Change Amphetamine (for conversion) 8,500,000 g No Change -> Amphetamine (for sale)* 25,300,000 g 33,400.000 g * DEA has determined that the revised total quantity to provide for the estimated medical, sclent) fie, research, and industrial needs of the United States, lawful export requirements, and the establishment and maintenance of reserve stock is 29,400,000 g. DEA has further determined that an additional 4,000,000 g is necessary to provide for future research and development needs and unexpected emergencies that could affect market availability. Carfentanil 0j> 1JL 6 Vol. I Page 502 Cocaine 216,000 g No Change Codeine (for conversion) 65,000,000 g No Change Codeine (for sale) 39,605,000 g No Change Dextropropoxyphene lA No Change Dihydrocodeine 400,000 g No Change Diphenoxylate 900,000 g No Change Ecgonine 83,000 g No Change Ethylmorphine - 8 No Change Fentanyl 1,428,000 g No Change Glutethimide u No Change Hydrocodone (For sale) 59,000,000 g 63,000,000 g Hydrotnorphone 3,455,000 g 3,628,000 g Isomethadonc 4g No Change Lcvo-alphacetylmethadol (LAAM) 3 g No Change Levomethorphan 5g No Change Levorphanol 3,600 g No Change Lisdexamfetamine 12,000,000 g No Change Meperidine 5,500,000 g No Change Meperidine Intermediate-A 5_R No Change Meperidine Intermediate-B 2jl No Change Meperidine Intermediate-C 5* No Change Meta2ocine la No Change Methadone (for sale) 20,000,000 g No Change Methadone Intermediate 26,000,000 g No Change Methamphetamine 3,130,000 g No Change [750,000 grams of levo-desoxycphedrine for use in a non-controlled, non-prescription product; 2,331,000 grams for methamphetamine mostly for conversion to a schedule III product; and 49,000 grams for methamphetamine (for sale)l Methylphenidate 56,000,000 g No Change Morphine (for conversion) 83,000,000 g No Change Morphine (for sale) 39,000,000 g No Change Nabilone 20,502 g" No Change Noroxymorphone (for conversion) 7,200,000 g No Change Noroxymorphone (for sale) 401,000 g 1,981.000 g Opium (powder) 63,000 g 73,000 g Opium (tincture) 1,000,000 g No Change Oripavine 9,800,000 g 15,300,000 g Oxycodone (for conversion) 5,600,000 g No Change Oxycodone (for sale) 98,000,000 g 98,700,000 g Oxymorphone (for conversion) 12,800,000 g No Change Oxymorphone (for sale) 5,500,000 g No Change Pentobarbital 34,000,000 g No Change Phenazocine Is. No Change 7 Vol. I Page 503 Phencyclidine 24 g No Change Phenmetrazine 2 g No Change Phenylacetone 1 6,000,000 g No Change Racemethorphan 2_g No Change Remifetitanil 2,500 g No Change Secobarbital 336,002 g No Change Sufentanil 5,000 g No Change Tapentadol 5,400,000 g No Change Thebaine 11 6,000,000 g No Change Aggregate production quotas for all other schedule I and II controlled substances included in 21 CFR 1308.1 1 and 1308.12 remain at zero. Pursuant to 21 CFRPart 1303, the Deputy Administrator may adjust the 2012 aggregate production quotas and individual manufacturing quotas allocated for the year. Comments Pursuant to 21 CFR 1303.1 1 and 1303.13, 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. In the event the Deputy Administrator decides in his sole discretion to hold such a hearing, the Deputy Administrator will publish a notice of any such hearing in the Federal Register. After consideration of any comments and after a hearing, if one is held, the Deputy Administrator will publish in the Federal Register a Final Order determining any adjustment of the aggregate production quota. Dated: Michele M. Leonhart Administrator 8 Vol. I Page 504 OC: OD: OD/D: ' ODX: ODXS: ODW: ODQ: QDQ;|(b)(6) Webcims # (DFN#: 680-03 Drug control files - Manufacturing and Procurement quotas) 9 Vol. I Page 505 •SS-s?. Federal Register/Vol. 77, No. 129/Thursday, July 5, 2012 /Notices 39737 San Rafael, California; Canadian Solar devices to reduce emissions of various DEPARTMENT OF JUSTICE Inc. of Kitchener, Ontario, Canada; and air pollutants. The complaint seeks both Canadian Solar (USA) Inc. of San injunctive relief and civil penalties. Drug Enforcement Administration Ramon, California. Id. The proposed Decree lodged with the [Docket No. DEA-363] On May 25, 2012, all of the private Court requires installation and parties filed a joint motion to terminate operation of certain pollution control Controlled Substances: Proposed the investigation based on confidential Adjustment to the Aggregate devices at the Alma/J.P. Madgett and settlement agreements under Production Quotas for 2012 Genoa plants, and the permanent ^ Commission rules 210.21(a)(2) and (b). cessation of operations of certain units The Commission investigative attorney AGENCY: Drug Enforcement supported the motion. at the Alma/J.P. Madgett plant. The Administration (DEA). Department of On June 13, 2012. the presiding ALJ settlement will reduce emissions of Justico. issued an ID (Order No. 11) granting the sulfur dioxide ("SO;"), nitrogen oxides ACTION: Notice with request for joint motion. No party petitioned for ("NOx"), and particular matter ("PM") comments. review of the ID. through emission control requirements The authority for the Commission's and limitations specified by the SUMMARY: This notice proposes to adjust the 2012 aggregate production quotas for determination is contained in section proposed Decree. Dairyland will also several controlled substances in 337 of the Tariff Act of 1930, as fund environmental projects at a cost of amended, 19 U.S.C. 1337, and in section at least $5 million to mitigate the schedules I and II of the Controlled Substances Act (CSA). 210.42(h) of the Commission's Rules of alleged adverse effects of its past Practice and Procedure, 19 CFR violations, and will pay a civil penalty DATES: Electronic comments must be 210.42(h), of S9SO.OOO. submitted and written comments must be postmarked on or before August 6, By order of the Commission. The Department of Justice will receive 2012. Commenters should be aware that Issued: June 29.2012. for a period of thirty (30) days from the the electronic Federal Docket Lisa R. Barton, date of this publication comments Management System will not accept Acting Secretary the Commission. relating to the Consent Decree. comments after midnight Eastern Time [re Doc. 2012-16433 riled 7-3-12; 8:45 ain| Comments should be addressed to the on the last day of the comment period. ailUNO CODE 7070-02-P Assistant Attorney General, ADDRESSES: To ensure proper handling Environment and Natural Resources of comments, please reference "Docket Division, and either emailed to No. DEA-363" on all electronic and DEPARTMENT OF JUSTICE [email protected] or written correspondence. DEA mailed to P.O. Box 7611, U.S. encourages all comments be submitted Notice of Lodging of Proposed Department of Justice, Washington, DC electronically through http:// Consent Decree With Dairyland Power 20044-7611, and should refer to United wivw.regu/ations.govusing the Cooperative Under the Clean Air Act States v. Dairyland Power Cooperative, electronic comment form provided on Pursuant to 28 CFR 50.7. notice is D.J. Ref. 90-5-2-1-10163. that site. An electronic copy of this hereby given that on June 28. 2012, a During the public comment period, document is also available at the proposed Consent Decree in United the Consent Decree may also be http://www.regulutions.gov Web site for States of America v. Dairyland Power examined on the following Department easy reference. Paper comments that Cooperative ("Dairyland"), Civil Action of Justice Web site, http:// duplicate the electronic submission are not necessary as all comments No. 12-cv-462. was lodged with the www.usdoj.gov/enrd/ submitted to www.reguJahons.gov will United States District Court for the Consenl_Decrees.html. A copy of the be posted for public review and are part Western District of Wisconsin. Consent Decree may also be obtained by of the official docket record. Should In this civil enforcement action under mail from the Consent Decree Library, the federal Clean Air Act ("Act"), the you. however, wish to submit written P.O. Box 7611, U.S. Department of United States alleges that Dairyland—an comments via regular or express mail, Justice, Washington, DC 20044-7611 or electric utility—failed to comply with (hey should be sent to the Drug by faxing or emailing a request to certain requirements of the Act intended jj Enforcement Administration, Attention; 'Consent Decree Copy" to protect air quality. The complaint DEA Federal Register Representative/ [[email protected]), fax no. alleges that Dairyland violated the ODL, 8701 Mcrrissette Drive. (202) 514-6097, phone confirmation Prevention of Significant Deterioration Springfield, VA 22152. number (202) 514-5271. If requesting a ("PSD") and Title V provisions of the FOR FURTHER INFORMATION CONTACT: John Act, 42 U.S.C. 7401-7671 etseq., and copy from the Consent Decree Library W. Partridge, Chief, Liaison and Policy related state and federal implementing by mail, please enclose a check in the Section, Drug Enforcement regulations, at the Alma/J.P. Madgett amount of S24.25 (25 cents per page Administration, 8701 Morrissette Drive, Generating Station, a coal-fired power reproduction cost) payable to the U.S. Springfield, VA 22152, Telephone: (202) plant in Buffalo County, Wisconsin, and Treasury or, if requesting by email or 307-4654. the Genoa Generating Station, a coal- fax. forward a check in thai amount to SUPPLEMENTARY INFORMATION: fired power plant in Vernon County, the Consent Decree Library at the Posting of Public Comments Wisconsin. The alleged violations arise address given above. from the construction of modifications Please note that all comments Maureen Kalz, at the power plants and operation of the received are considered part of the plants in violation ofPSD and Title V Assistant Chief, Environmental Enforcement public record and made availahle for Section, Environment end Natural Resources requirements. The complaint alleges public inspection online at http:// Division. that Dairyland failed to obtain www.regu/at/ons.govand in the DEA's appropriate permits and failed to install [FR Doe. 2012-16353 Filed 7-3-12: S:4S ami public docket. Such information and apply required pollution control BILUNG CODE 4410-1S-P includes personal identifying Vol. I Page 506 39738 Federal Register/Vol. 77, No. 129/Thursday/July 5, 2012/Notices information (such as your name, Information Act applies to all comments Changes in demand for the class, address, etc.) voluntarily submitted by received. If you wish to inspeel the changes in the national rate of net the commenter. agency's puolic docket file in person by disposal for the class, and changes in lfyou want to submit personal appointment, please see the FOR the rale of net disposal by the registrants Identifying information (such as your FURTHER INFORMATION CONTACT holding individual manufacturing name, address, etc.] as part of your paragraph. quotas for the class; (2] whether any increased demand or changes in the comment, but do not want it to be Background posted online or made available in the national and/or individual rates of net Section 306 of the CSA (21 U.S.C. public docket, yau must include the disposal are temporary, short term, or 626) requires that the Attorney General phrase "PERSONAL IDENTIFYING long term; [3] whether any increased establish aggregate production quotas INFORMATION" in the first paragraph demand can be met through existing for each basic class of controlled of your comment. You must also place inventories, increased individual substance listed in schedules I and II. all the personal identifying information manufacturing quotas, or increased This responsibility has been delegated you do not want posted online or made importation without increasing the - to the Administrator of the DEA by 28 available in the public docket in the first aggregate production quota; (4) whether CFR 0.100. The Administrator, in turn, paragraph of your comment and identify any decreased demand will result in has redelegated this function to the what information you want redacted. excessive inventory accumulation by all Deputy Administrator, pursuant to 28 Ifyou want to submit confidential persons registered to handle the class; CFR 0.104. The 2012 established and (5) other factors affecting the business information as part of your aggregate production quotas for comment, but da not want it to bo medical, scientific, research, and controlled substances in schedules 1 and industrial needs of the United States posted online or made available in the II were published in the Federal public docket, you must include the and lawful export requirements, as the Register (76 FR 78044) on December 15. Administrator finds relevant. phrase "CONFIDENTIAL BUSINESS 2011. That notice stipulated that, as INFORMATION" in the first paragraph provided for in 21 CFR 1303.13, all In determining whether to propose of your comment. You must also aggregate production quotas are subject adjustments to the 2012 aggregate prominently identify confidential to adjustment. production quotas, DEA considered business information to be redacted updated information obtained from within the comment. If a comment has Analysis for Proposed Revised 2012 2011 year-end inventories. 2011 so much confidential business Aggregate Production Quotas disposition data submitted by quota information that it cannot be effectively DEA now proposes to adjust the applicants, estimates of the medical redacted, all or part of that comment established 2012 aggregate producti on needs of the United Stales, product may not be posted online or made quotas for some schedule I and II development, and other information available in the public docket. controlled substances. In proposing the made available to DEA after the initial Personal identifying information and adjustment, DEA has taken into account aggregate production quotas had been confidential business information the criteria that DEA is required to established. The Deputy Administrator, identified and located as set forth above consider in accordance with 21 CFR therefore, proposes to adjust the 2012 will be redacted, and the comment, in 1303.13. DEA proposes the adjustment aggregate production quotas for some redacted form, will be posted online and of the aggregate production quotas far schedule I and II controlled substances, placed in the DEA's public docket file. basic classes of schedule I and II expressed in grams of anhydrous acid or Please note that the Freedom of controlled substances by considering [1] base, as follows; Previously Proposed Basic class established adjusted 2012 2012 quotas quotas Schedule I 1-[1-|2-Thienyl)cyclohexyI]piperidine 0g sg. 1-[2-{4-Morpholinyl)ethyl]-3-(1-naphthoyl)indo!e (JWH-200) 45 g No Change. 1-Bulyl-3-(1-naphthoyl)iridcle (JWH-073) 45 g No Change. 1-Methyl-4-phenyl-4-propionoxypiperldine 29 No Change. 1 •Pentyl-3-(1-naphthoyl)indole (JWH-016) 45 g No Change. 2,5-Dlmethoxyamphetamine 2 g 12 9- 2.5-Dimethoxy-4-ethylamphetamine (DOET) 2 g 12 g. 2.5-Oimethoxy-4-n-propylthiophenethytamine 2 g 12 g. 3-Methylfentanyl 29 No Change. 3-Methyllhiofeniany l 2 g No Change. 3,4-Melhylenedioxyamphelamine (MDA) 22 9 30 g 3.4-Methylenedioxy-N-methylcathinone (methyloae) 89 129 3.4-Methylencdioxy-N-ethylamphQtamlne (MDEA) 15 g 24 g 3,4-Methylenedioxynethamphetamine (MDMA) 22 g 30 g 3,4-Melhylenedioxypyrovalerone (MDPV) 8 g 12 9 3.4. 5Trimethoxyamph etamine 29 12 g 4-Bromo-2,5-dimeihoxyamphelamiae (OOB) 29 12 g 4-Bramo-2,5-ditneihoxyphenethylamirie (2-CB) 2 9 12 g 4-Methoxyamphetamine ... 77 g 80 g 4-Melhylaminarex ... 2g 12 g 4-Mcthyl-2,5- Vol. I Page 507 Federal Register/ Vol. 77, No. 129/Thursday. July 5, 2012/Notices 39739 Previously Proposed Basic class established adjusted 2012 201 2 quotas quotas 5-Methoxy-3,4-methylenedloxyamphetamire 2g 12 g. 5-Melhoxy-N,N-diisoprcpyltryptamir»e 2 9 12 g. Acetyl-alpha-melhylfentanyl 2g . No Change. Acetyldihydrocodeine 2 g .. No Change. Acetylmethedol 2g .. No Change. Allylprodine 2g . No Charge. Alphacetylmethadol 2g . No Change. Alpha-ethyilryptamine 2g .. 12 g. Alphameprodine 2 g .. No Change. Alphamelhadol 2 g . No Change. AJpha-methylfentanyl 2 g .. No Change. Alpha-methyllhlofentanyl 2g. , No Change. Alptia-methyltryptamine (AMT) 2g 12 g. Aminorex 2g 12 g. Benzylmorphine 29 . No Change. Beiaeetyimethadol 2 g . No Change. Bela-hydroxy-3-methylfentanyl 2 g . No Change. Beta-hydroxyfentanyl 2 g . No Change. Beiameprodine 2 g . No Change. Belameihadol 2 g . No Change. Belaprodine 2 g . No Change. Butotenine 3g . No Change. Cathinone 4g 12 g. Codeinc-N-oxide 602 g No Change. Diethyltryptamine 2g 12 9- Dilenoxin 50 g No Change. Dihydromorphine 3,608,000 g No Change. Dimethyltrypiamlne 7 g 18 g. Garnma-hydroxybulyric acid 47.000,000 g .... No Change. Heroin 20 g No Change. Hydromorphinol 54 g No Change. Hydroxypelhidine 2g No Charge. Ibogaine 5 g No Charge. Lysergic acid diethylamide (ISO) 16 g No Change. Marihuana 21.000 g No Change. Mescaline s g 13 g. Melhaqualone 10 g No Change. Melhcathinone 4g 12 g. Methytdihydromorphine 2 g No Change. Morphine-N-oxide 655 g No Change. N-Benzylplperazine 29 I2g. N.N-Oimethylamphetamlne 2g i2g. N-Ethylamphetamine 2 g 12 g. N-Hydroxy-3,4-melhyienedioxyarrphetamire 29 12 g. Noracymethadol 2 g No Change. Nortevorphanol 52 g No Change. Normethadone 2g No Change. Normorphine ..._ 18 g . No Change. Para-lluorofertanyl 2g No Change. Ptienomorphan 2 g No Change. Pholcodine 2g No Change. Properdins 2g No Change. Psilocybln 2g No Change. Psilocyn 2 g No Change. Tetrahydrocannabinols 393,000 g No Change. Thlofentanyl 2g No Change. Tilidine 10 g No Change. Trimeperidine 2g No Change. Schedule II 1-Phenyieyelohexylamine 29 No Change. I-Piperdlnaeyctohexanecarbonltrile 29 27 g. 4-Ani1ino-N-phenethyl-4-piperidine (ANPP) 1.800.000 g No Change. Allenlanil 15.000 g .... 19,550 g. Alphaprodine 2 g No Change. Amobarbital 40,007 g No Change. Amphelamine (lor conversion) 8,500.000 g. Amphetamine (lor sale)* 25.300.000 g 33.400.000 g. Vol. I Page 508 39740 Federal Register/Vol. 77, No, 129/Thursday, July 5, 2012/Notices Previously Proposed Basle class established adjusted 2012 2012 quotas quotas * DEA has determined lhal the revised total quantity 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 slock is 29,400,000 g. DEA has further determined lhal an additional 4,000,000 g Is nccossary lo provide for future research and development needs and unexpected emergencies that could affect market availability. Carfentanil Og Sg. Coeaine 216,000 g No Change. Codeine (for conversion) 65,000,000 g .... No Change. Codeine (for sale) 39,605,000 g .... No Change. Oexlropropoxyphene 7g No Change. Dihydrocodeine 400,000 g No Change. Diphenoxylate 900,000 g No Change. Ecgonina 83,000 g No Change. Ethylmorphine 2g No Change. Fentanyl 1 ,428,000 g No Change. Glulelhimide 29 No Change. Hydrocodone (for sale) 59,000,000 g .... 63,000.000 g. Hydromorphone 3,455,000 g 3,628,000 g. Isomethadone 4g . No Change. Levo-alphacetytmethadol (LAAM) 3.g . No Change. Levomethorphan 5g . No Change. Levorphanol 3,600 g . No Change. Lisdexamfetamine 12,000,000 g . No Change. Meperidine 5,500,000 g . . No Charge. Meperidine Intermediate-A 5g No Charge. Meperidine Irtermediate-B ...... 9g No Change. Meperidine Intermediate-C 5g No Change. Metazocine sg No Change. Methadone (for sale) 20.000.000 g .... No Change. Methadone Intermediate 26.000.000 g .... No Change. Methamphetamlne 3,130,000 g No Change. [750,000 grams of levo-desoxyephednne for use in a non-fcontrolled, non-prescription product; 2,331 ,000 grams for methamphetamine mostly for conversion to a schedule III product; and 49.000 grams for methamphetamine (for sale)] Methylphenidate . 56,000,000 g .... No Change. Morphine (for conversion) . 83,000,000 g .... No Change. Morphine (lor sale) . 39,000,000 g .... No Change. Nabilone . 20,502 g No Change. Noroxymorphone (for conversion) . 7,200.000 g No Change. Noroxymorphone (tor sale) . 401,000 g 1.981,000 g. Opium (powder) . 63,000 g 73,000 g. Opium (tincture) . 1,000,000 g No Change. Oripavirie . 9,800,000 g 15,300,000 g. Oxycodone (for conversion) . 5,600,000 g No Change. Oxycodone (for sale) . 98,000,000 g .... 98,700,000 g. Oxymorphone (for conversion) .... . 12,800,000 g .... No Change. Oxymorphone (for sale) . 5,500,000 g No Change. Pentobarbital . 34,000,000 g .... No Change. Phenazoeins 59 No Change. Phencyelidlne 24 g No Change. Phenmelrazine 2 g No Change. Phenylacelone 16,000,000 g .... No Change. Racemethorphan - 2g No Change. Remifenlanil . 2,500 g No Change- Secobarbital . 336,002 g No Change. Sufentanil . 5,000 g No Change. Tapentadol . 5,400,000 g No Change. Thebaine . 11 6,000.000 g .. No Change. Aggregate production quotas for all Comments raised. In the event the Deputy other schedule I and II controlled Pursuant to 21 CFR 1303.11 and Administrator decides in his sole substances included in 21 CFR 1308.11 1303.13. any interested person may discretion to hold such a hearing, the and 1308.12 remain at zero. Pursuant to submit written comments on or Deputy Administrator will publish a 21 CFR part 1303, the Deputy objections to these proposed notice of any such hearing in the Administrator may adjust the 201 2 determinations. Based on comments Federal Register. After consideration of aggregate production quotas and received in response lo this Notice, the any comments and after a hearing, if one individual manufacturing quotas Deputy Administrator may hold a is held, the Deputy Administrator will allocated for the year. public hearing on one or more issues publish in the Federal Register a Final Vol. I Page 509 Federal Regisler/Vol. 77, No. 129/Thursday, July 5, 2012/Notices 39741 Order determining any adjustment of . to 21 CFR 1301.43. and in such form as Applicants are encouraged to use the aggregate production quota. prescribed by 21 CFR 1316.47. Federal Express, UPS. or similar service Any such written comments or Dated: June 28.2012. to ensure delivery by the due date. objections should be addressed, in Hand delivered applications should Michele M. Leonhart, quinluplicate, to the Drug Enforcement be brought to S00 First Street NW., Administrator. Administration, Office of Diversion Washington, DC 20S34. At the front (FREOC. 2012-16396 Filed 7-3-12: 8:45 ami Control, Federal Register Representative desk, dial 7-3106. extension 0 for BELLING CODE 4410-CJ-P (ODL), 8701 Morrissotte Drive. pickup. Springfield. Virginia 22152; and must be Faxed applications will not be filed no later than August 6, 2012. accepted. Electronic applications can be DEPARTMENT OF JUSTICE This procedure is to ho conducted submitted via http://www.grants.gov. simultaneously with, and independent rug Enforcement Administration FOR FURTHER INFORMATION CONTACT: All of, tho procedures described In technical or programmatic questions 21 CFR 1301.34(b), (c). (d), (e), and (f). Importer of Controlled Substances; concerning this announcement should Notice of Application; Myoderm As noted in a previous notice published be directed to Michael Guevara, in the Federal Register on September Correctional Program Specialist. Pursuant to Title 21 Code of Federal 23, 1975, 40 FR 43745-46. all applicants National Institute of Corrections. Mr. Regulations 1301.34(a), this is notice for registration to import a basic class of Guevara can he reached by calling 800 that on May 9, 2012, Myodorm. 46 East any controlled substance in schedules I 995-6429, ext. 6617, or by email at Main Street, Norristown, Pennsylvania or II are, and will continue to be, [email protected]. In addition to the 19401, made application to the Drug required to demonstrate to the Deputy direct reply, all questions and responses Enforcement Administration (DEA) for Assistant Administrator, Office of will be posted on NIC's Web site at registration as an importer of the Diversion Control. Drug Enforcement www.nicic.gov for public review (the following basic classes of controlled Administration, that the requirements names of those submitting questions substances: for such registration pursuant to 21 will not be posted). The Web site will U.S.C. 958(a); 21 U.S.C. 823(a); and 21 be updated regularly and postings will Drug Schedule CFR 1301.34(b), (c), (d). (e), and (f) are remain on the Web site until the closing satisfied. date of this cooperative agreement Amphetamine (1100) lisdexamfetamine (1205) Dated: June 28, 2012. solicitation. Only questions received by MelhyiphenMate (1724) Joseph T. Rannazzisi, 12 p.m. (EDT) on July 13. 2012 will be Pentobarbital (2270) Deputy Assistant Administrator, Office of posted on the NIC Web site. Nabilone (7379) Diversion Control. Drug Enforcement SUPPLEMENTARY INFORMATION: Codeine (9050) Administration. Overview: NIC is revitalizing its Oxycodone (9143) [FR Doc. 2012-16493 Filed 7-3-12: 8:45 um] trainer development series with the goal Hydromorphone (9150) BILLING CODE 4410-09-P of helping corrections agencies and Hydrocodone (9193) trainers improve staff training and Levomelhorphan (9210) Meperidine (9230) development. NIC is interested in Methadone (9250) DEPARTMENT OF JUSTICE updating some of its curricula, Methadone Intermediate (9254) .. including "Training Design and Morphine (9300) National Institute of Corrections Development," "Foundation Skills for Oxymorphone (9652) Trainers," "Building Agency Success: Solicitation for a Cooperative Fentanyl (9801) Developing an Effective FTO/OJT Agreement—Curricula Review and Training Program," and "Training for Revision: NIC Trainer Development The company plans to import the Training Directors." NIC is also Series ' listed controlled substances in finished interested in the development of a dosage form for clinical trials, and AGENCY: National Institute of model Training for Trainers template research. Corrections, U.S. Department of Justice. that could be applied broadly, enabling The import of the above listed basic action: Solicitation for a Cooperative agencies to train trainers in existing classes of controlled substances would Agreement. , curricula. ' be granted only for analytical testing All curricula will follow the and clinical trials. This authorization ' SUMMARY; The National Institute of Instructional Theory into Practice (ITIP) does not extend to the import of a Corrections' (NIC) Academy Division is model and will incorporate blended finished FDA approved or non- soliciting proposals from organizations, learning strategies. A copy of the "ITIP approved dosage form for commercial groups, or individuals lo enter into a Toolkit." which may be useful in distribution in the United States. cooperative agreement for the review, helping awardccs develop acceptable Any bulk manufacturer who is revision, and/or development of curricula, is available on the NIC Web presently, or is applying to be, competency-based, blended modality site at http://nicic.gov/Librory/024773. registered with DEA to manufacture training curricula with the aim of An essential component of this project such basic classes of controlled providing corrections agencies and will be the incorporation of current substances listed in schedule I or II, professionals with the knowledge, research on adult learning and which fall under the authority of section skills, and abilities needed to Irain and performance. The use of multiple 1002(a)(2)(B) of the Act 2 1 U.S.C. develop their staff. delivery technologies is required. 952(a)(2)(B) may, in the circumstances DATES: Application must be received by Background: NIC has prioritized set forth in 21 U.S.C. 958(i], file 4 p.m. (EDT) on Friday, July 20, 2012. capacity building in corrections comments or objections to the issuance A0DRESSES: Mailed applications must be agencies for decades. While NIC of the proposed registration and may, at sent to: Director, National Institute of frequently relied on traditional the same time, file a written request for Corrections, 320 First Street NW., Room classroom-based training in the past, the a hearing en such application pursuant 5002, Washington. DC 20534. emergence of new technologies and the Vol. I Page 510 ) ) Substance 2012* 30-50% inventory salt total a base total Notes pd efforts 2011 exports lAlfentanil 0.407 0.243 0.730 0.900 0.657 most dispositions are exports 2.760 5.633 Amphetamine 22,211.267 8,684.507 31,095.774 33,427.957 multiple salts 337.136 509.777 Cocaine.,.,,, y, 46.054 13.816 59.870 0.890 53.285 0.005 0.228 Codeine 25,473.127 12,736.563 38,209.690. 0.860 32,860.333 46.131 1,216.533 Dihydrocodeinet'.'--*. 89.749 - ' •• 44.874 134.623 0.640 , 86.159 0.000 0.003 Diphenoxylate 411.656 205.828 617.484 0.930 574,260 made into schedule 5 preps 0.000 41.852 Fentanyl 569.110 170.733 739.843 1.000 739.843 16.375 175.328 Hydrocodone 'J-';.; 64,786:963 y 19,436.089 , '84,223.052 . ^ 0.610 51,376.062 . .• " .686.160 30.306 Hydromorphone 1,896.024 568.807 2,464.831 0.890 2,193.699 209.098 550.175 Levofphanolj^g r., : &S1;344 ••^.^'">^^0:672 • . •1.000 '2.016 vy; 0.000 0.004 Lisdexamfetamine 13,925,864 6,962.932 20,888.795 0.580 12,115.501 532.500 0.195 Meperidine frfo-SS '. 2,'134:683 .-7@y "a?.1i067:341 3,202.024 0.870 . 2,785:761 V: Vo..- 73.0851 583.594 Methadone 7,443.038 2,232.911 9,675:949 0.890 8,611.595 85.600 390.134 Methamphetamirie; 14:494 ^Vr.^ftty,y7;247 ^>-; A»21.741 ., 0.600 V" ' ^ 17.393 7.. r- 0.082 Methylphenidate 20,563.448 6,169.034 26,732.483 0.870 23,257.260 836.220 8,766.604 Morphine -31,061.877 15,530.938 " ?46;592:815 :&^mg.0.?5Q ^ 34;944.611 .-£*/ .6,405.397 ,' v • ,547.128 Nabilone 0.045 0.022 0.067 1.000 0.067 0.000 Opium •. 81:843 40.921 . • :-122.764 .^SSIiOOQ . ,?P122;764 -Vh •• •• 0.000' Oxycodone 68,325.161 20,497.548 88,822.709 0.900 79,940.438 4,626.726. 6,061.125 Qxymorphone'- 2;1 79.282 *1:089,641 3:268.923 ,7-05g;go:890 . 2.909.342' J ' . 2,566.825 : ' 18.191 Pentazocine 713.667 356.834 1,070.501 1.000 1,070.501 Pentobarbital is^r:^i">y;35:557 ^;106.671 &r..^"-0.910 . • '97.071 mostly used in vet medicince 51.999 5,247.353 i Remifentanll^-g»*ga .^syi.133 .-50.566 . :•: 1.699 .. 0.910 ;p '„1>546 i ' 1VI.500 0.237 Secobarbital 16.680 8.340 25.020 0.920 23.018 o.ooo Sufentanil:- •?-''J^rfafe'.0.Q67|^;^ .-;^f,.^S0.034| ^ i-:0M0l|.;.--, 0.670 0.068 0.873 1.502 Tapentadol 5,900,110 2,950.055 8,850,165 0.860 7 ,6 1 1 .1 42 1 importation 0.000 Vol. I Page 51 1 Billing Code 44 1009-M DEPARTMENT OF JUSTICE Drug Enforcement Administration (Docket No. DEA-363) Controlled Substances: Final Adjusted Aggregate Production Quotas for 2012 AGENCY: Drug Enforcement Administration (DEA), Department of Justice. ACTION: Notice. SUMMARY: This notice establishes final adjusted 2012 aggregate production quotas for controlled substances in Schedules I and II of the Controlled Substances Act (CSA). FOR FURTHER INFORMATION CONTACT: John W. Partridge, Chief, Liaison and Policy Section, Drug Enforcement Administration, 8701 Morrissette Drive, Springfield, VA 22152, Telephone: (202) 307-4654. SUPPLEMENTARY INFORMATION: Background Section 306 of the CSA (21 U.S.C. 826) requires that the Attorney General establish aggregate production quotas for each basic class of controlled substance listed in Schedules I and II, This responsibility has been delegated to the Administrator of the DEA by 28 CFR 0.100. In accordance with 21 U.S.C. 826 and 21 CFR 1303.1 1, DEA published in the Federal Register on December 15, 201 1, notice of the established 2012 aggregate production quotas for controlled substances in Schedules I and II (76 FR 78044). That notice staled that the Administrator would adjust, as needed, the established aggregate production quotas in 2012 as provided for in 21 CFR 1303. 13. The 2012 proposed adjusted aggregate production quotas were subsequently published in the Federal Register on July 5, 2012 (77 FR 39737) in consideration of the outlined criteria. Vol. I Page 512 All interested persons were invited to comment on or object to the proposed adjusted aggregate production quotas on or before August 6, 2012. Analysis for Final Adjusted 2012 Aggregate Production Quotas Consideration has been given to the criteria outlined in the July 5, 2012, notice of proposed adjusted aggregate production quotas in accordance with 21 CFR 1303.13. In addition, nine companies, eight DEA registered manufacturers and one non-registrant, submitted timely comments regarding a total of 23 Schedule 1 and II controlled substances. Comments received proposed that the aggregate production quotas for 3,4-Methylenedioxy-N-Methylcathinone (methylone), alfentanil, amphetamine (for conversion), amphetamine (for sale), codeine (for conversion), codeine (for sale), desomorphine, dihydromorphine, hydrocodone (for sale), hydromorphone, levomethorphan, lisdexamfetamine, methadone intermediate, methylphenidate, morphine (for conversion ), morphine (for sale), noroxymorphone (for conversion), noroxymorphone (for sale), oripavine, oxycodone (for conversion), oxycodone (for sale), oxymorphone (for conversion), oxymoiphone (for sale), sufentanil, and tapentadol were insufficient to provide for the estimated medical, scientific, research, and industrial needs of the United States, for export requirements, and for the establishment and maintenance of reserve stocks. DEA has taken into consideration the above comments along with the relevant 201 1 year- end inventories, initial 2012 manufacturing quotas, 2012 export requirements, actual and projected 2012 sales, research and product development requirements, and additional applications received. Based on all of the above, the Administrator has determined that the proposed adjusted 2012 aggregate production quotas for 3,4-Methylenedioxypyrovalerone (MDPV), 3,4-Methylenedioxy-N-Methylcathinone (methylone), 4-Methyl-N-Methylcathinone Vol. I Page 513 (mephedrone), alfentanil, amphetamine (for conversion), desomorphine, dihydromorphine, gamma hydroybutyric acid, hydrocodone (for sale), hydromorphone, levomethorphan, methadone, methadone intermediate, methylphcnidate, morphine (for sale), oxycodone (for conversion), oxycodone (for sale), and sufentanil required additional consideration and hereby further adjusts the 2012 aggregate production quotas for those substances. Regarding amphetamine (for sale), codeine (for conversion), codeine (for sale), morphine (for conversion), noroxymorphone (for conversion), noroxymorphone (for sale), oripavine, oxymorphone (for conversion), oxymorphone (for sale), and tapentadol, the Administrator hereby determines that the proposed adjusted 2012 aggregate production quotas for these substances as published on July 5,2012, at 77 FR 39737 are sufficient to meet the current 2012 estimated medical, scientific, research, and industrial needs of the United States and to provide for adequate inventories. Pursuant to the above, the Administrator hereby establishes the 20 12 final aggregate production quotas for Schedule I and II controlled substances, expressed in grans of anhydrous acid or base, as follows: Final Adjusted Basic Class - Schedule I 2012 Quotas 1 -[ 1 -(2-Thienyl)cyclohexyl]piperidine la l-[2-(4-MorphoHnyl)ethyll-3-(l-naphthoy])indole (JWH-200) 45 g 1 -Butyl-3-( 1 -naphthoyl)indole (JWH-073 ) 45 g l-MethyM-phenyl-4-propionoxypipcridine la l-Pentyl-3-(I-naphthoyl)indole (JWH-018) 45 g 2,5-Dimethoxyamphetamine 111 2,5-Dimethoxy-4-ethylamphetamine (POET) 12g 2,5-Dimethoxy-4-n-propylthiophenethylamin.e 12 g 3-Methylfentanyl la 3-Methylthiofentanyl ll 3,4-Methylencdioxyamphetamine (MPA) 30 g 3,4-Methylenedioxy-N-methylcathinone (methylone) 30 g 3,4-Methylenedioxy-N-ethylamphetamine (MDEA) 24 g 3,4-Methylenedioxymethamphetamine (MDMA) 30 g 3,4-Methylcnedioxypyrovalerone (MDPV) 20 g 3,4,5-Trimethoxyamphetamine 12 g Vol. I Page 514 4-Bromo-2,5-dimethoxyamphetamine (DQB) ill 4-Bromo-2,5-dimethoxyphenethylamine (2-CB) IJjl 4-Methoxyamphetamine 88 g 4-Methylaminorex \2jl 4-Methyl-2,5-dimelhoxyamphetamine (DOM) 111 4-Melhyl-N-methylcathinonc (mephedrone) 25 g 5-(l,l-Dimethylheptyl)-2-[(lR,3S)-3-hydroxycyclohexyll-phenol 68 g 5-(l,l-Dimethyloctyl)-2-[(lR,3S)-3-hydroxycyclohexyll-phenol 53^ 5-Methoxy-3,4-mcthylencdioxyamphetaminc 111 5-Methoxy-N,N-diisopropyltryptamine Hi Acetyl-alpha-methylfentanyl ll Acetyldihydrocodeine ll Acetylmcthadol 2g Allylprodine ll Alphacetylmethadol ll Alpha-ethyltryptamine 12 g Alphameprodine ll ' Alphamcthadol ll Alpha-methylfentanyl ll Alpha-methylthiofentanyl ll Alpha-methyltryptamine (AMT) 111 Aminorex 12 g Benzylmorphine ll Betacetylmethadol ll Beta-hydroxy-3-methylfentanyl ll Beta-hydroxyfcntanyl ll Betameprodine ll Betamethadol 2JL Betaprodine ll Bufotenine ll Cathinone 111 Codeine-N-oxidc 602 g Desomorphine 10g Diethyltryptamine 18 g Difenoxin 50 g Dihydromorphine 3,750,000 g Dimethyltryptamine 18 g Gamma-hydroxybutyric acid 37,000,000 g Heroin 20 g Hydromorphinol 54 g Hydroxypethidine ll Ibogaine ; 5g Lysergic acid diethylamide (LSD) 16 g Marihuana 21,000 g Mescaline 13 g Vol. I Page 515 Methaqualone 10 g Methcathinone 12 g Methyldihydromorphine 2g Morphine-N-oxide 655 g N-Benzylpiperazinc 12 g N,N-Dimethylamphetamin& 12 g N-Ethylamphetamine N-Hydroxy-3,4-methylenedioxyamphetamine 12 g Noracymethadol • l£ Norlevorphanol "I Normethadone lA Normorphine 18 g Para-fluorofentanyl 2g Phenomorphan 2g Pholcodine 1a Properidine la Psilocybin 2 g Psilocyn la Tetrahydrocannabinols 393,000 g Thiofenlanyl lA Tilidine 10g Trimeperidine la Final Adjusted Basic Class - Schedule II 2012 Quotas 1 -Phenylcyclohexylamine la 1 -Piperdinocyclohexanecarbonitrile 2ia 4-Anilino-N-phcnethyl-4-piperidine (ANPP) 1,800,000 g Alfentanil 29,002 g Alphaprodine la Amobarbital 40,007 g Amphetamine (for conversion) 13,300,000 g Amphetamine (for sale) 33,400,OQOg Carfentanil 5g Cocaine 21 6,000 g Codeine (for conversion) 65,000,000 g Codeine (for sale) 39,605,000 g Dextropropoxyphene 7g Dihydrocodeine 400,000 g Diphenoxylate 900,000 g Ecgonine 83,000 r Ethylmorphine 2g Fentanyl 1,428,000 g Glutethimide lA Hydrocodone (for sale) 79,700,000 g Vol. I Page 516 Hydromorphone 4,207,000 g Isomethadotie il Levo-alphacetylmethadol (LAAM) la Levomethorphan 10g Levorphanol 3,600 g Lisdexamfetamine 12,000,000 g Meperidine 5,500,000 g Meperidine Intermediate-A la Meperidine Intermediate-B 9g Meperidine Intermediate-C Metazocine la Methadone (for sale) 23,100,000 g Methadone Intermediate 29,970,000 g Methamphetamine 3,130,000 g [750,000 grams of levo-desoxyephedrine for use in a non-controlled, non prescription product; 2,33 1,000 grams for methamphetamine mostly for conversion to a schedule III product; and 49,000 grams for methamphetamine (for sale)] Methylphenidate 64,600,000 g Morphine (for conversion) 83,000,000 g Morphine (for sale) 48,200,000 g Nabilone 20,502 g Noroxymorphone (for conversion) 7,200,000 g Noroxymorphone (for sale) 1,98 1,000 g Opium (powder) 73,000 g Opium (tincture) 1,000,000 g Oripavine 15,300,000 g Oxycodone (for conversion) 5,600,000 g Oxycodone (for sale) 105,200,000 g Qxymorphone (for conversion) 12,800,000 g Qxymorphone (for sale) 5,500,000 g Pentobarbital 34,000,000 g Phenazocine Is. Phencyclidine 24 g Phenmetrazine 2jl Phenylacetone 16,000,000 g Racemcthorphan 2g Remifentanil 2,500 g Secobarbital 336,002 g Sufentanil 6,730 g Tapentadol 5,400,000 g Thebaine 1 16,000,000 g" Aggregate production quotas for all other Schedule I and II controlled substances included in 21 CFR 1308.11 and 1308.12 remain at zero. Vol. I Page 517 Dated: Michelc M. Lconhart, Administrator OC: OD: OD/D: ODX: ODXS: ODW: ODQ: ODQ:|(b>(6> Webcims # (DFN#: 680-03 Drug control files - Manufacturing and Procurement quotas) Vol. I Page 518 •SSS3 rt-ikyjr 55500 Federal Register/ Vol. 77, No. 175/Monday, September 10, 2012/Notices copy from the Consent Decree Library established 2012 aggregate production DEA has taken into consideration the by mail, please enclose a check in the quotas for controlled substances in above comments along with the relevant amount of S3. 75 (S.25 per page) payable Schedules I and II (76 FR 78044). That 2011 year-end inventories, initial 2012 to the U.S. Treasury or. if by email or notice staled that the Administrator manufacturing quotas, 2012 export fax, forward a check in that amount to would adjust, as needed, the established requirements, actual and projected 2012 the Consent Decree Library at the aggregate production quotas in 2012 as sales, research and product address given above. provided for in 21 CFR 1303.13. The development requirements, and 2012 proposed adjusted aggregate Robert Brook, additional applications received. Based production quotas were subsequently on all of the above, the Administrator Assistant Chief, Environmental Enforcement published in the Federal Register on Section, Environment and Natural Resources has determined that the proposed July S. 2012 (77 FR 39737) in Division. adjusted 2012 aggregate production consideration of the outlined criteria. [FR Doc. 2012*22121 Filed 9-7-12: 8:45 am) quotas for 3,4- All interested persons were invited to Methylenedioxypyrovalcrono (MDPV). BILUNQ CODE 4410-15-T comment on or object to the proposed 3,4-Methylenedioxy-N-MethyIcathinone adjusted aggregate production quotas on (methylone), 4-Methyl-N- or before August 6, 2012, DEPARTMENT OF JUSTICE Methylcalliinone (mephedrone), Analysis for Final Adjusted 2012 alfentanil, amphetamine (for Drug Enforcement Administration Aggregate Production Quotas conversion), desomorphine. (Docket No. DEA-3S3J Consideration has been given to the diethyltryptamine, dihydromorphine, criteria outlined in the July 5, 2012, gamma hydroxybutyric acid, Controlled Substances: Final Adjusted notice of proposed adjusted aggregate hydrocodone (for sale), hydromorphone, Aggregale Production Quotas for 201 2 production quotas in accordance with levomethorphan, methadone, AGENCY: Drug Enforcement 21 CFR 1303.13. In addition, nine methadone intermediate, Administration (DEA), Department of companies, eight DEA registered methylphenidate. morphine (for sale), Justice. manufacturers and one non-registrant, oxycodone (for conversion), oxycodone ACTION: Notice. submitted timely comments regarding a (for sale), and sufentanil required total of 25 Schedule I and II controlled additional consideration and hereby SUMMARY: This notice establishes final substances. Comments received further adjusts the 2012 aggregate adjusted 2012 aggregate production proposed that the aggregate production production quotas for those substances. quotas for controlled substances in quotas for 3,4-Methylenedioxy-N- Regarding amphetamine (for sale), Schedules 1 and II of the Controlled Methylcathinone (methylone), codeine (for conversion], codeine (for Substances Act (CSA). alfentanil, amphetamine (for sale), morphine (for conversion], FOR FURTHER INFORMATION CONTACT: John conversion), amphetamine (for sale), noroxymorphone (for conversion), VV. Partridge, Chief, Liaison and Policy codeine (for conversion), codeine (for noroxymorphone (for sale), oripavine, Section, Drug Enforcement sale), desomorphine, dihydromorphine, oxymorphone (for conversion], Administration. 8701 Morrissette Drive, hydrocodone (for sale), hydromorphone, oxymorphone (for sale), and tapentadol, Springfield, VA 22152, Telephone: (202) levomethorphan, lisdoxamfctaminc, the Administrator hereby determines 307-4654. methadone Intermediate, that the proposed adjusted 2012 SUPPLEMENTARY INFORMATION: methylphenidate, morphine (for conversion), morphine (for sale), aggregate production quotas for these Background noroxymorphone Ifor conversion], substances as published on July 5, 2012, . at 77 FR 39737 are sufficient to meet the Section 306(a) of the CSA (21 U.S.C. noroxymorphone (for sale), oripavine, 826) requires that the Attorney General oxycodone (for conversion), oxycodone current 2012 estimated medical, establish aggregate production quotas (for sale), oxymorphone (for scientific, research, and industrial needs for each basic class of controlled conversion], oxymorphone (for sale), of the United States and to provide for substance listed in Schedules I and II. sufentanil, and tapentadol were adequate inventories. Pursuant to the This responsibility has been delegated insufficient to provide for the estimated above, the Administrator hereby to the Administrator of the DEA by 28 medical, scientific, research, and establishes the 2012 final aggregate CFR 0.100. In accordance with 21 U.S.C. industrial needs of the United Slates, for production quotas for Schedule 1 and II 826 and 21 CFR 1303.11, DEA export requirements, and for the controlled substances, expressed in published in the Federal Register on establishment and maintenance of grams of anhydrous acid or base, as December 15, 2011, notice ofthe reserve stocks. follows: Final adjusted 2012 quotas Basle Class—Schedule I 1-(1-(2-Thienyl)cyclohexyl]piperidlne 5 g l-i2-(4-Morpliolioyl)ethylJ-3-(1-naphthoyl)indole (JWH-200) 45 g 1-Butyl-3-(1-naphlhoyl)indole (JWH-073) 45 g 1-MelhyM-phenyl-4-propionoxypiperidine 2 g l-Pentyl-3-(1-naphlhoyl)indole (JWH-018) 45 g 2,5-Dimelhoxyampheiamine '2 g 2,5-Dimethoxy-4 athylamphe1amIne (DOET) 12 g 2,5-Dimeil!Oxy-4-n-prapylir»lophenethylamine 12 g 3-Methyifentanyl 2g 3-MethyIlhiofentanyl 2g 3,4-Methylenedioxyairipbetamlne (MOA) 30 g Vol. I Page 519 Federal Register/Vol. 77, No. 175/Monday, September 10, 2012/Notices 55501 Final adjusted 2012 quotas 3.4-Melhylenedioxy-N-methylcathinone (methylone) 30 g 3.4-Melhy!anedioxy-N-elhy (amphetamine (MOEA) 24 g 3,4-Melhylenedioxymethamphetamine (MDMA) 30 g 3.4-Methylenedioxypyrovalerone (MDPV) 20 g 3.4,5-Trlmethoxyamphetamine 12 g 4-Bromo-2.5-dimethoxyamphetamine (DOB) i2g 4-Bromo-2.5-dimethoxyphenelhylariine (2-CB) 12 g 4-Methoxyamphetamine 88 g 4-Methylaminorex t2g 4-Methyl-2,5-dimethoxyamphetamine (DOM) 12 9 4-Methyl-N-methylcathincne (mephedrone) 25 g 5-(1,i-Dimethylheplyl)-2-((1fi.3S)-3-hydroKycyclahexyl]-phenol 68 g S-(1,1-Oimethyloctyl]-2-[(1R,3S)-3-hydraxycyc1ahexyl]-phencl , 53 g 5-Methoxy-3,4-meiriylenedioxyamphetamine I2g 5-Methoxy-N.N-diisopropyllryptamine I2g Acetyl-alpha-mcthylfentanyl 2 g Acetyldihydrocodclne 2g Aeetylmethadol 29 Allyfprodine 29 Alphacetylmethadol 2 g Alpha-ethyllryplamine 12 g Alphameprodine 2g Alphamethadol 2g Alpha-methyllentanyl 2 g Alpha-methylthiolentanyl 2g Alpha-melhyltryptamine (AMT) 12 g Aminorex 12 g Beniylmorphine 2g Belacetylmethadol 2 g Bela-hydraxy-3-meihyKenlanyl 2 g Beta-hydroxyfentanyl zg Betameprodine 2 g Betamethadol 2 g Betaprodinc 2 g Bulotenine • A- 3 g Caihinone 12 g Codeine-N-oxide 602 g Desomorphine 10 g Dielhyllryptamine 18 g Oifenoxin 50 g Oihydromorphine 3,750,000 g Dimethyltryptamine 18 g Gamma -hydroxy butyric acid 37,000,000 g Heroin 20 g Hydromorphinol 54 g Hydroxypethidino 29 Ibogaine 5g Lysergie acid diethylamide (LSD) 16 g Marihuana 21.000 g Mescaline 13 g Methaqualone 10 g Methcathinone 12 g Methyldihydromorphine 2 g Morphine-N-oxide 655 g N-Benzylpiperazine 129 N.N-Dimethylamphelamine 12 9 N-Ethylamphetamine 12 g N-Hydroxy-3,4-melhylenedioxyamphe(amine 12 g Noracymethadol 2 g Norlevorphanol 52 g Normethadone 29 Normorphire 16 g Para-tluorofentanyl 2 g Phenomorphan 2g Pholcodinc 2 g Pmperidine 2 g 2 g Psilocyn 2 g Tetrahydrocannabinols 393,000 g Thiofentanyl 2g Tilidine 10 g Trimeperidine 2g Vol. I Page 520 55502 Federal -Register/Vol. 77, No. 175 / Monday, September 10, 2012/Noticcs Final adjusted 2012 quotas Basle Class—Schedule II i-Phenyicyclohexylamine 2g 1-Piperdinocyclohexanecarbonilrile 27 g 4-Anilino-N-phenethyl-4-p:peridine (ANPP) 1,800,000 g Alfenlanil 29.002 g Alphaprodine 2 g Amobartjital 40.007 g Anphetamino (for conversion) 13,300.000 g Amphetamine (for sale) 33.400.000 g Carlerlanil 5g Cocaine 216.000 g Codeine (for conversion) 65.000.000 g Codeine (lor sale) 39,605.000 g Dextropropojyphene 7g Dihydrocodeine 400.00G g Diphenoxylate 900.000 g Ecgonine 63,000 g Elhylmotphine 2 g Fentanyl 1,428,000 g Giuteihimide 2g Hydrocodone (lor sale) 79.700.000 g Hydrcmorphone 4,207.000 g Isomethadone 4g Levo-alphacetylmelhadol (LAAM) 3 9 Levomethorphan 10 g Lcvorphanol 3.600 g Lisdexamfetamine 12,000.000 g Meperidine 5.500.000 g Meperidine Intermediate-A 5g Meperidine Inlermediate-B 99 Meperidine Inlermediale-C sg Metazoeine 59 Methadone (lor sale) 23.100.000 g Methadone Intermediate 29,970.000 g Methamphelamine 3.130,000 g [750,000 grams of levo-desoxyephedrine for use in a non-controlled, non-prescription product; 2,331,000 grams for methamphelamine mostly for conversion 1o a schedule til product; and 49,000 grams lor melhamphetamine (for sale)] Methylphenldate 64.600,000 g Morphine (for conversion) 83,000,000 g Morphine (for sale) 48.200,000 g Nabilone 20,502 g Noroxymorphone (for conversion) 7.200,000 g Noroxymorphone (for sale) ... 1,981,000 g Opium (powder) 73,000 g Opium (tincture) 1,000,000 g Oripavine 15.300,000 g Oxycodone (lor conversion) 7,600.000 g Oxycodone (lor safe) 105200,000 g Oxymorphone (for conversion) .... 12.800,000 g Oxymorphone (for sale) 5,500,000 g Penlobarbital 34,000.000 g Phcnazocine 5 9 Phencyclidine 24 g Phenmetrazine 29 Phenylacetene 16,000,000 g Aacemelhorphan 2 g Remifentaml 2,500 g Secobarbital 336,002 g Sulenlanil 6,730 g Tapentadol 5,400,000 g Thebaine 116,000,000 g Vol. I Page 521 Federal Regisler/Vol. 77, No. 175 /Monday, September 10, 2012/Notices 55503 Aggregate production quotas for all Phenylpropanolamine for 2012" was needs, as published on September 14, other Schedule I and It controlled published in the Federal Register (77 2011, at 76 FR 56809. substances included in 21 CFR 1309.11 FR 42333). That notice proposed to In accordance with 21 U S.C. 826(a) and 1308.12 remain at zero. adjust the 2012 Assessment of Annual and 21 CFR 1315.13, the Administrator Daled: August 31. 2012. Needs for ephedrine (far sale), hereby orders that the 2012 assessment ephedrine (for conversion), of annual needs for ephedrine, Michele M. Leonhart, psnudcephodrinc (for sale), pscudoephcdrinc. and Administrator. phenylpropanolamine (for sale) and phenylpropanolamine, expressed in IFK Doc. 2012-22126 Filed 0-7-12: 6:45 ami phenylpropanolamine (for conversion). kilograms of anhydrous acid or base, is ilLUHG cooe 4110-49-P All interested persons were invited In adjusted and established as follows: comment on or object to the proposed assessments on or before August 17, Final 2012 DEPARTMENT OF JUSTICE assessment of 2012. List I chemical annual needs Drug Enforcement Administration Comments Received (kg) DEA did not receive any comments to (Docket No. D6A 353J Ephedrine (for sale) 4.300 the proposed adjustment of the Phenylpropanolamine (for Final Adjusted Assessment of Annual assessment of annual needs far sale) 5,800 Needs for the List I Chemicals ephedrine (for sale), ephedrine (for Pseudoephedrine (for sale] .. 278.000 Ephedrine, Pseudoephediine, and conversion), pscudoephcdrinc (for sale), Phenylpropanolamine (for Phenylpropanolamine for 2012 phenylpropanolamine (for sale), and conversion) 26.200 phenylpropanolamine (for conversion). Ephedrine (for conversion) ... 12,000 ACENCY: Drug Enforcement Adminislratian (DEA). Department of Conclusion Daled: August 31 , 2012. lustice. In determining the adjusted 2012 Michele M. Leotihart. action; Notice. assessments, DEA used the calculation Administrutor. methodology previously described in SUMMARY; This notice establishes the the 2010 and 2011 assessment of annual |FR Dee. 2012-22127 Filed 9-7-12; 8:45 am) Final Adjusted 2012 Assessment of needs (74 FR 60294 and 75 FR 79407 BILLING CODE 4410-09-P Annual Needs for the list I chemicals respectively). DEA considered changes ephedrine, pseudoephedrine. and in demand, changes in the national rate DEPARTMENT OF JUSTICE phenylpropanolamine. of net disposal, and changes in the rate of net disposal by the registrants DATES: Effective Dale: September 10. Drug Enforcement Administration 2012. holding individual manufacturing or import quotas for the chemical; whether Importer of Controlled Substances; FOR FURTHER INFORMATION CONTACT! John any increased demand or changes in the Notice of Registration; Cambrex W. Partridge, Chief, Liaison and Policy national and/or individual rates of net Charles City, Inc. Section, Drug Enforcement disposal are temporary, short term, or Administration. 6701 Morrissette Drive. long term; whether any increased By Notice dated June 18, 2012, and Springfield, VA 22152, Telephone: (202) demand could be met through existing published in the Federal Register on 307-4654. inventories, increased individual June 26, 2012, 77 FR 38085, Cambrex SUPPLEMENTARY INFORMATION: The 2012 manufacturing quotas, or increased Charles City. Inc.. 1205 11th Streel, Assessment of Annual Needs represents importation without increasing the Charles City, Iowa 50616-3466, made those quantities of ephedrine, assessment of annual needs: whether application by renewal to the Drug pseudoephedrine, and ' any decreased demand would result in Enforcement Administration (DEA) to phenylpropanolamine which may be excessive inventory accumulation by all be registered as an importer of the manufactured domestically and persons registered to handle the following basic classes of controlled imported into the United States in 2012 particular chemical: and other factors substances: to provide adequate supplies of each affecting the medical, scientific, chemical for the estimated medical, research, industrial, and importation rug Schedule scientific, research, and industrial needs needs in the United States, lawful 4*Anilino*N-phenelhyl-4*piperidine II of the United States, lawful export export requirements, and reserve stocks, (8333). requirements, and the establishment as found relevant. Phenylacelone (8501) II and maintenance of reserve slocks of Other factors that DEA considered Opium, raw (9600) II such chemicals. Section 306 of the include trends as derived from Poppy Straw Concentralo (9670) II Controlled Substances Act (CSA) (21 information provided in applications for U.S.C. 826) requires that the Attorney import, manufacturing, and The company plans to import the General establish an assessment of procurement quotas and in import and listed controlled subslanccs for internal annual needs for ephedrine, export declarations. Tho inventory, use, and to manufacture bulk pseudoephedrine, and acquisition (purchases], and disposition intermediates for sale to its customers. phenylpropanolamine. This (sales] data as provided by DEA* No comments or objections have been responsibility has been delegated In the registered manufacturers and importers received. Comments and requests for Administrator of the DEA by 28 CFR reflects the most current information hearings on applications tu import 0.100. available to DEA at the time of narcotic raw material are not On July 18, 2012. a notice entitled publication of this Notice. The apipropriate. 72 FR 3417 (2007). "Proposed Adjustment of the underlying data used to determine the DEA has considered the factors in 21 Assessment of Annual Needs for the List final 2012 assessment of annual needs is U.S.C. 023(a) and 952(a). and I Chemicals Ephedrine, the same as that used in determining the determined that the registration of Pseudoephedrine, and proposed 201 2 assessment of annual Cambrex Charles City, Inc. to import the Vol. I Page 522 1 ) ) 201 2 APQ BuicClut; mm -a wotthnu m T«UI(Ck DtAtVo »12JJQR«p*l1 2012 WO 2011 UW% 2011 TCUlSi1** %<4 2*11S*lM »h«^rtni2 rcniw 20U9**fW|r 29l2Pw*n»dfc*p«iw C4t«y*ioflC*«>0XiMc.y Cft'« UtiiQ CfR m inwii !b)(4) (b)(4);(b) inn 3PM DOM 31.W0.1I7 6«9 DOOO OOM 14V oooe .1 &M -161ft iM coo 103020 5 723 H.2N.31 7 689 00W 3775 »«» 0«0 -»M9 >2* Sift !7)(E) *45.000000 MJ.OCCMO 3U29.31 f«» 0006 1U.U00M 2?4.M>3.0CO QOM •"ftft.760745 auajonuo U.41 4.003 «0 1ftj3J.tM.OOC 11,220.517 ft N 0323 :4.J«7.1»755M 1.3M.457.0C0 9.01JJCP669 1l.60ftft11.20ft U,14U49 kllibii: M^ftJ.IMfOO 12«5lC5WO 11J»i17«4 10, *14990102 «7.1ft9JOO FUMlkttMAPCt 19605.000050 PtOv**44P***+± YiKn_ctt> t CODEINE (FOR SALE) Vol. I Page 523 ) ) M1Z R*fiMd APQ WW n.rn.coo® FD*f«r oow 1*5E»* Cog* XAtm DtAUm «12*Ofi«iu*f 291* MQ »11til*i 1911 Toul Sim x<**0116»k* f**of»12TontP«J *011 h**«io* 20t2Pir*«cMd p-aP» C*r< Uotag CFft 30* tn%«m cak Uikifl crn sox tiv**i (b)(4) (b)(4);(b)(7) ii.roo.ow om o^.ocd.ow SOKJl&OW M619.040OQ0 DA 01 oooa BW.U4 091 DOM WIWDOfi vanvrjo 74.OOa.OMOW BJCrSOOLfEO a ooo w.fi UOTaoK 72.709.000009 42.WJXOOCO W,fli9.6«0.«O 13 HPJ.6460W oao -IKDO.MOOO FhillfuiM'Q: 05.0*3 . tun an Pf»cMd &***+£ 4S.WaC9M F&ut RnttM *PQ; o.ooo wo H~6*p « COOEfNG (FOR C07JVEKSKJU) / Vol. I Page 524 ) Mt3 R*-ria*d APQ LUticCUii: 91744 wmsuMti PQ T©U*CW«P0): t.OOO mi CM: .1100* (MS Git 9 COO* CGmpiny pg* Hum MlSHtQFUquit 9012 HQ 2011 SH«» 2011 Tolil SaIqa *«f 2011 S«i«i ^•'•ofsoiaroniPC C*e lltlrtg CFn CiM U»nj CfR W%fcw<*nt (b)(4) (b)(4);(b)( 2.000 7 WO O0OO 5S1S60000 OOOQ O.00Q 0000 0.000 6000 aooo 7DCOQOCC 20.000.000 acoo •5 87.950.0)0 QWO ocw 0 003 0 000 0.006 0003 7)(E) 49.560600 29.000 WO oero £97.850 000 0O3C 0 MQIcUK: » .0:8,502000 099^2 000 597.850 0» xm.S77.floa la.eoaooo -9M.977 OCO fin* W«*1 API* DW.OWoOO J /5 3>W0 Fin* Ravta*dAPO: 0 000 - 1,207.377A00 CFW90H; -1.058.0W 250 iDiiuouiwa 02? .003 000 fOA EM » 2fll I APO - fOA 117.90)600 «SClt-»ll APO-IMS*; 747.111400