80 FR 55642 - Final Adjusted Aggregate Production Quotas for Schedule I and II Controlled Substances and Assessment of Annual Needs for the List I Chemicals Ephedrine, Pseudoephedrine, and Phenylpropanolamine for 2015
DEPARTMENT OF JUSTICE
Drug Enforcement Administration Federal Register Volume 80, Issue 179 (September 16, 2015)
Drug Enforcement Administration
Federal Register Volume 80, Issue 179 (September 16, 2015)
| Page Range | 55642-55646 | |
| FR Document | 2015-23199 |
[Federal Register Volume 80, Number 179 (Wednesday, September 16, 2015)] [Notices] [Pages 55642-55646] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2015-23199] ======================================================================= ----------------------------------------------------------------------- DEPARTMENT OF JUSTICE Drug Enforcement Administration [Docket No. DEA-418F] Final Adjusted Aggregate Production Quotas for Schedule I and II Controlled Substances and Assessment of Annual Needs for the List I Chemicals Ephedrine, Pseudoephedrine, and Phenylpropanolamine for 2015 AGENCY: Drug Enforcement Administration, Department of Justice. ACTION: Final order. ----------------------------------------------------------------------- SUMMARY: This final order establishes the final adjusted 2015 aggregate production quotas for controlled substances in schedules I and II of the Controlled Substances Act and the assessment of annual needs for the list I chemicals ephedrine, pseudoephedrine, and phenylpropanolamine. DATES: This order is effective September 16, 2015. FOR FURTHER INFORMATION CONTACT: John R. Scherbenske, Office of Diversion Control, Drug Enforcement Administration, 8701 Morrissette Drive, Springfield, Virginia 22152; Telephone: (202) 598-6812. SUPPLEMENTARY INFORMATION: Legal Authority The Drug Enforcement Administration (DEA) implements and enforces titles II and III of the Comprehensive Drug Abuse Prevention and Control Act of 1970, as amended. 21 U.S.C. 801-971. Titles II and III are referred to as the ``Controlled Substances Act'' and the ``Controlled Substances Import and Export Act,'' respectively, and are collectively referred to as the ``Controlled Substances Act'' or the ``CSA'' for the purposes of this action. The DEA publishes the implementing regulations for these statutes in title 21 of the Code of Federal Regulations (CFR), chapter II. The CSA and its implementing regulations are designed to prevent, detect, and eliminate the diversion of controlled substances and listed chemicals into the illicit market while providing for the legitimate medical, scientific, research, and industrial needs of the United States. Controlled substances have the potential for abuse and dependence and are controlled to protect the public health and safety. Section 306 of the CSA (21 U.S.C. 826) requires the Attorney General to establish aggregate production quotas for each basic class of controlled substance listed in schedules I and II and for ephedrine, pseudoephedrine, and phenylpropanolamine. This responsibility has been delegated to the Administrator of the DEA. 28 CFR 0.100(b). Background The DEA established the initial 2015 aggregate production quotas for controlled substances in schedules I and II and the assessment of annual needs for the list I chemicals ephedrine, pseudoephedrine, and phenylpropanolamine on September 8, 2014. 79 FR 53216. That notice stated that the DEA could adjust, as needed, the established aggregate production quotas and assessment of annual needs in accordance with 21 CFR 1303.13 and 21 CFR 1315.13. The proposed adjusted 2015 aggregate production quotas for controlled substances in schedules I and II and assessment of annual needs for the list I chemicals ephedrine, pseudoephedrine, and phenylpropanolamine were subsequently published in the Federal Register on July 8, 2015, 80 FR 39156, in consideration of the outlined criteria. All interested persons were invited to comment on or object to the proposed adjusted 2015 aggregate production quotas and assessment of annual needs on or before August 7, 2015. Analysis for Final Adjusted 2015 Aggregate Production Quotas and Assessment of Annual Needs Consideration has been given to the criteria outlined in the July 8, 2015, notice of proposed adjusted aggregate production quotas and assessment of annual needs, 80 FR 39156, in accordance with 21 CFR 1303.13 and 21 CFR 1315.13. Five companies submitted timely comments regarding twelve schedule I and II controlled substances. These comments suggested that the proposed adjusted aggregate production quotas for codeine (for sale), fentanyl, gamma hydroxybutric acid, hydrocodone (for sale), methadone, methadone intermediate, methylphenidate, morphine (for conversion), oripavine, oxycodone (for sale), oxymorphone (for conversion), and oxymorphone (for sale) 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. The DEA did not receive any comments related to the proposal not to adjust the 2015 assessment of annual needs for ephedrine, pseudoephedrine, and phenylpropanolamine. In accordance with 21 CFR 1303.13, the DEA has taken into consideration the above comments along with the relevant 2014 year-end inventories, initial 2015 manufacturing and import quotas, 2015 export requirements, actual and projected 2015 sales, research and product development requirements, and the additional quota applications received. Upon consideration of the above, the Administrator determined that the proposed adjusted 2015 aggregate production quotas for dihydroetorphine, ethylmorphine, etorphine HCl, racemethorphan, racemorphan, methylphenidate, and oxycodone (for sale) required additional consideration and hereby further adjusts the proposed 2015 aggregate production quotas for these substances. Regarding codeine (for sale), fentanyl, gamma hydroxybutric acid, hydrocodone (for sale), methadone, methadone intermediate, morphine (for conversion), oripavine, oxymorphone (for conversion), and oxymorphone (for sale) the Administrator hereby determines that the proposed adjusted 2015 aggregate production quotas for these substances as published in the Federal Register on July 8, 2015, 80 FR 39156, are sufficient to meet the current 2015 estimated medical, scientific, research, and industrial needs of the United States and to provide for adequate reserve stock. As described in the previously published notice establishing the 2015 aggregate production quotas and assessment of annual needs, the DEA has specifically considered that inventory allowances granted to individual manufacturers may not always result in the availability of sufficient quantities to maintain an adequate reserve stock pursuant to 21 U.S.C. 826(a), as intended. See 21 CFR 1303.24. This would be concerning if a natural disaster or other unforeseen event resulted in substantial disruption to the amount of controlled substances available to provide for legitimate public need. As such, the DEA included in all schedule II aggregate production quotas, and certain schedule I aggregate production quotas, an additional 25% of the estimated medical, scientific, and research needs as part of the amount necessary to ensure the establishment and maintenance of reserve stocks. The final established aggregate production quotas will reflect these included [[Page 55643]] amounts. This action will not affect the ability of manufacturers to maintain inventory allowances as specified by regulation. The DEA expects that maintaining this reserve in certain established aggregate production quotas will mitigate adverse public effects if an unforeseen event results in substantial disruption to the amount of controlled substances available to provide for legitimate public need, as determined by the DEA. The DEA does not anticipate utilizing the reserve in the absence of these circumstances. Pursuant to the above, the Administrator hereby finalizes the 2015 aggregate production quotas for the following schedule I and II controlled substances and the 2015 assessment of annual needs for the list I chemicals ephedrine, pseudoephedrine, and phenylpropanolamine, expressed in grams of anhydrous acid or base, as follows: ------------------------------------------------------------------------ Final adjusted Basic class 2015 quotas (g) ------------------------------------------------------------------------ Schedule I ------------------------------------------------------------------------ (1-Pentyl-1H-indol-3-yl)(2,2,3,3- 25 tetramethylcyclopropyl)methanone (UR-144)........... [1-(5-Fluoro-pentyl)-1H-indol-3-yl](2,2,3,3- 25 tetramethylcyclopropyl)methanone (XLR11)............ [1-(5-fluoropentyl)-1H-indazol-3-yl](naphthalen-1- 15 yl)methanone (THJ-2201)............................. 1-(1,3-Benzodioxol-5-yl)-2-(methylamino)butan-1-one 25 (butylone).......................................... 1-(1,3-Benzodioxol-5-yl)-2-(methylamino)pentan-1-one 25 (pentylone)......................................... 1-(1-Phenylcyclohexyl)pyrrolidine.................... 10 1-(5-Fluoropentyl)-3-(1-naphthoyl)indole (AM2201).... 45 1-(5-Fluoropentyl)-3-(2-iodobenzoyl)indole (AM694)... 45 1-[1-(2-Thienyl)cyclohexyl]piperidine................ 15 1-[2-(4-Morpholinyl)ethyl]-3-(1-naphthoyl)indole (JWH- 45 200)................................................ 1-Butyl-3-(1-naphthoyl)indole (JWH-073).............. 45 1-Cyclohexylethyl-3-(2-methoxyphenylacetyl)indole (SR- 45 18 and RCS-8)....................................... 1-Hexyl-3-(1-naphthoyl)indole (JWH-019).............. 45 1-Methyl-4-phenyl-4-propionoxypiperidine............. 2 1-Pentyl-3-(1-naphthoyl)indole (JWH-018 and AM678)... 45 1-Pentyl-3-(2-chlorophenylacetyl)indole (JWH-203).... 45 1-Pentyl-3-(2-methoxyphenylacetyl)indole (JWH-250)... 45 1-Pentyl-3-(4-chloro-1-naphthoyl)indole (JWH-398).... 45 1-Pentyl-3-(4-methyl-1-naphthoyl)indole (JWH-122).... 45 1-Pentyl-3-[(4-methoxy)-benzoyl]indole (SR-19, RCS-4) 45 1-Pentyl-3-[1-(4-methoxynaphthoyl)]indole (JWH-081).. 45 2-(2,5-Dimethoxy-4-n-propylphenyl)ethanamine (2C-P).. 30 2-(2,5-Dimethoxy-4-ethylphenyl)ethanamine (2C-E)..... 30 2-(2,5-Dimethoxy-4-methylphenyl)ethanamine (2C-D).... 30 2-(2,5-Dimethoxy-4-nitro-phenyl)ethanamine (2C-N).... 30 2-(2,5-Dimethoxyphenyl)ethanamine (2C-H)............. 30 2-(4-Bromo-2,5-dimethoxyphenyl)-N-(2- 25 methoxybenzyl)ethanamine (25B-NBOMe; 2C-B-NBOMe; 25B; Cimbi-36)...................................... 2-(4-Chloro-2,5-dimethoxyphenyl)ethanamine (2C-C).... 30 2-(4-Chloro-2,5-dimethoxyphenyl)-N-(2- 25 methoxybenzyl)ethanamine (25C-NBOMe; 2C-C-NBOMe; 25C; Cimbi-82)...................................... 2-(4-Iodo-2,5-dimethoxyphenyl)ethanamine (2C-I)...... 30 2-(4-Iodo-2,5-dimethoxyphenyl)-N-(2- 15 methoxybenzyl)ethanamine (25I-NBOMe; 2C-I-NBOMe; 25I; Cimbi-5)....................................... 2-(Methylamino)-1-phenylpentan-1-one (pentedrone).... 15 2,5-Dimethoxy-4-ethylamphetamine (DOET).............. 25 2,5-Dimethoxy-4-n-propylthiophenethylamine........... 25 2,5-Dimethoxyamphetamine............................. 25 2-[4-(Ethylthio)-2,5-dimethoxyphenyl]ethanamine (2C-T- 30 2).................................................. 2-[4-(Isopropylthio)-2,5-dimethoxyphenyl]ethanamine 30 (2C-T-4)............................................ 3,4,5-Trimethoxyamphetamine.......................... 25 3,4-Methylenedioxyamphetamine (MDA).................. 55 3,4-Methylenedioxymethamphetamine (MDMA)............. 50 3,4-Methylenedioxy-N-ethylamphetamine (MDEA)......... 40 3,4-Methylenedioxy-N-methylcathinone (methylone)..... 50 3,4-Methylenedioxypyrovalerone (MDPV)................ 35 3-Fluoro-N-methylcathinone (3-FMC)................... 25 3-Methylfentanyl..................................... 2 3-Methylthiofentanyl................................. 2 4-Bromo-2,5-dimethoxyamphetamine (DOB)............... 25 4-Bromo-2,5-dimethoxyphenethylamine (2-CB)........... 25 4-Fluoro-N-methylcathinone (4-FMC)................... 25 4-Methoxyamphetamine................................. 100 4-Methyl-2,5-dimethoxyamphetamine (DOM).............. 25 4-Methylaminorex..................................... 25 4-Methyl-N-ethylcathinone (4-MEC).................... 25 4-Methyl-N-methylcathinone (mephedrone).............. 45 4-Methyl-[alpha]-pyrrolidinopropiophenone (4-MePPP).. 25 5-(1,1-Dimethylheptyl)-2-[(1R,3S)-3- 68 hydroxycyclohexyl]-phenol........................... 5-(1,1-Dimethyloctyl)-2-[(1R,3S)-3-hydroxycyclohexyl]- 53 phenol (cannabicyclohexanol or CP-47,497 C8-homolog) 5-Methoxy-3,4-methylenedioxyamphetamine.............. 25 5-Methoxy-N,N-diisopropyltryptamine.................. 25 5-Methoxy-N,N-dimethyltryptamine..................... 25 Acetyl-alpha-methylfentanyl.......................... 2 [[Page 55644]] Acetyldihydrocodeine................................. 2 Acetylmethadol....................................... 2 Allylprodine......................................... 2 Alphacetylmethadol................................... 2 alpha-Ethyltryptamine................................ 25 Alphameprodine....................................... 2 Alphamethadol........................................ 2 alpha-Methylfentanyl................................. 2 alpha-Methylthiofentanyl............................. 2 alpha-Methyltryptamine (AMT)......................... 25 alpha-Pyrrolidinobutiophenone ([alpha]-PBP).......... 25 alpha-Pyrrolidinopentiophenone ([alpha]-PVP)......... 25 Aminorex............................................. 25 Benzylmorphine....................................... 2 Betacetylmethadol.................................... 2 beta-Hydroxy-3-methylfentanyl........................ 2 beta-Hydroxyfentanyl................................. 2 Betameprodine........................................ 2 Betamethadol......................................... 4 Betaprodine.......................................... 2 Bufotenine........................................... 3 Cathinone............................................ 70 Codeine methylbromide................................ 5 Codeine-N-oxide...................................... 305 Desomorphine......................................... 25 Diethyltryptamine.................................... 25 Difenoxin............................................ 11,000 Dihydromorphine...................................... 3,990,000 Dimethyltryptamine................................... 35 Dipipanone........................................... 5 Fenethylline......................................... 5 gamma-Hydroxybutyric acid............................ 70,250,000 Heroin............................................... 50 Hydromorphinol....................................... 2 Hydroxypethidine..................................... 2 Ibogaine............................................. 5 Lysergic acid diethylamide (LSD)..................... 35 Marihuana............................................ 658,000 Mescaline............................................ 25 Methaqualone......................................... 10 Methcathinone........................................ 25 Methyldesorphine..................................... 5 Methyldihydromorphine................................ 2 Morphine methylbromide............................... 5 Morphine methylsulfonate............................. 5 Morphine-N-oxide..................................... 350 N-(1-Adamantyl)-1-pentyl-1H-indazole-3-carboxamide 25 (AKB48)............................................. N-(1-Amino-3,3-dimethyl-1-oxobutan-2-yl)-1-pentyl-1H- 25 indazole-3-carboxamide (ADB-PINACA)................. N-(1-Amino-3-methyl-1-oxobutan-2-yl)-1-(4- 25 fluorobenzyl)-1H-indazole-3-carboxamide (AB- FUBINACA)........................................... N-(1-Amino-3-methyl-1-oxobutan-2-yl)-1- 15 (cyclohexylmethyl)-1H-indazole-3-carboxamide (AB- CHMINACA)........................................... N-(1-Amino-3-methyl-1-oxobutan-2-yl)-1-pentyl-1H- 15 indazole-3-carboxamide (AB-PINACA).................. N,N-Dimethylamphetamine.............................. 25 Naphthylpyrovalerone (naphyrone)..................... 25 N-Benzylpiperazine................................... 25 N-Ethyl-1-phenylcyclohexylamine...................... 5 N-Ethylamphetamine................................... 24 N-Hydroxy-3,4-methylenedioxyamphetamine.............. 24 Noracymethadol....................................... 2 Norlevorphanol....................................... 52 Normethadone......................................... 2 Normorphine.......................................... 40 Para-fluorofentanyl.................................. 5 Parahexyl............................................ 5 Phenomorphan......................................... 2 Pholcodine........................................... 5 Psilocybin........................................... 30 Psilocyn............................................. 30 Quinolin-8-yl 1-(5-fluoropentyl)-1H-indole-3- 25 carboxylate (5-fluoro-PB-22; 5F-PB-22).............. Quinolin-8-yl 1-pentyl-1H-indole-3-carboxylate (PB- 25 22; QUPIC).......................................... Tetrahydrocannabinols................................ 511,250 Thiofentanyl......................................... 2 Tilidine............................................. 25 [[Page 55645]] Trimeperidine........................................ 2 ------------------------------------------------------------------------ Schedule II ------------------------------------------------------------------------ 1-Phenylcyclohexylamine.............................. 5 1-Piperidinocyclohexanecarbonitrile.................. 5 4-Anilino-N-phenethyl-4-piperidine (ANPP)............ 2,687,500 Alfentanil........................................... 17,750 Alphaprodine......................................... 3 Amobarbital.......................................... 25,125 Amphetamine (for conversion)......................... 21,875,000 Amphetamine (for sale)............................... 37,500,000 Carfentanil.......................................... 19 Cocaine.............................................. 275,000 Codeine (for conversion)............................. 50,000,000 Codeine (for sale)................................... 63,900,000 Dextropropoxyphene................................... 45 Dihydrocodeine....................................... 226,375 Dihydroetorphine..................................... 3 Diphenoxylate (for conversion)....................... 75,000 Diphenoxylate (for sale)............................. 1,337,500 Ecgonine............................................. 174,375 Ethylmorphine........................................ 5 Etorphine hydrochloride.............................. 3 Fentanyl............................................. 2,300,000 Glutethimide......................................... 3 Hydrocodone (for conversion)......................... 137,500 Hydrocodone (for sale)............................... 99,625,000 Hydromorphone........................................ 7,000,000 Isomethadone......................................... 5 Levo-alphacetylmethadol (LAAM)....................... 4 Levomethorphan....................................... 30 Levorphanol.......................................... 7,125 Lisdexamfetamine..................................... 29,750,000 Meperidine........................................... 6,250,000 Meperidine Intermediate-A............................ 6 Meperidine Intermediate-B............................ 32 Meperidine Intermediate-C............................ 6 Metazocine........................................... 19 Methadone (for sale)................................. 31,875,000 Methadone Intermediate............................... 34,375,000 Methamphetamine...................................... 2,061,375 ------------------------------------------------------------------------ [1,250,000 grams of levo-desoxyephedrine for use in a non-controlled, non-prescription product; 750,000 grams for methamphetamine mostly for conversion to a schedule III product; and 61,375 grams for methamphetamine (for sale)] ------------------------------------------------------------------------ Methylphenidate...................................... 96,750,000 Morphine (for conversion)............................ 91,250,000 Morphine (for sale).................................. 62,500,000 Nabilone............................................. 18,750 Noroxymorphone (for conversion)...................... 17,500,000 Noroxymorphone (for sale)............................ 1,475,000 Opium (powder)....................................... 112,500 Opium (tincture)..................................... 687,500 Oripavine............................................ 35,000,000 Oxycodone (for conversion)........................... 8,350,000 Oxycodone (for sale)................................. 141,375,000 Oxymorphone (for conversion)......................... 29,000,000 Oxymorphone (for sale)............................... 7,750,000 Pentobarbital........................................ 35,000,000 Phenazocine.......................................... 6 Phencyclidine........................................ 38 Phenmetrazine........................................ 3 Phenylacetone........................................ 9,375,000 Racemethorphan....................................... 5 Racemorphan.......................................... 3 Remifentanil......................................... 4,200 Secobarbital......................................... 215,003 Sufentanil........................................... 6,255 Tapentadol........................................... 12,500,000 Thebaine............................................. 125,000,000 ------------------------------------------------------------------------ [[Page 55646]] List I Chemicals ------------------------------------------------------------------------ Ephedrine (for conversion)........................... 1,000,000 Ephedrine (for sale)................................. 4,000,000 Phenylpropanolamine (for conversion)................. 44,800,000 Phenylpropanolamine (for sale)....................... 8,500,000 Pseudoephedrine (for conversion)..................... 7,000 Pseudoephedrine (for sale)........................... 224,500,000 ------------------------------------------------------------------------ Aggregate production quotas for all other schedule I and II controlled substances included in 21 CFR 1308.11 and 1308.12 remain at zero. Dated: September 10, 2015. Chuck Rosenberg, Acting Administrator. [FR Doc. 2015-23199 Filed 9-15-15; 8:45 am] BILLING CODE 4410-09-P
![55642 Federal Register / Vol. 80, No. 179 / Wednesday, September 16, 2015 / Notices
Jean Sonneman, substances have the potential for abuse establishment and maintenance of
Bureau of Land Management, Information and dependence and are controlled to reserve stocks. The DEA did not receive
Collection Clearance Officer, Bureau of Land protect the public health and safety. any comments related to the proposal
Management. Section 306 of the CSA (21 U.S.C. not to adjust the 2015 assessment of
[FR Doc. 2015–23257 Filed 9–15–15; 8:45 am] 826) requires the Attorney General to annual needs for ephedrine,
BILLING CODE 4310–84–P establish aggregate production quotas pseudoephedrine, and
for each basic class of controlled phenylpropanolamine.
substance listed in schedules I and II In accordance with 21 CFR 1303.13,
DEPARTMENT OF JUSTICE and for ephedrine, pseudoephedrine, the DEA has taken into consideration
and phenylpropanolamine. This the above comments along with the
Drug Enforcement Administration responsibility has been delegated to the relevant 2014 year-end inventories,
Administrator of the DEA. 28 CFR initial 2015 manufacturing and import
[Docket No. DEA–418F]
0.100(b). quotas, 2015 export requirements, actual
Final Adjusted Aggregate Production and projected 2015 sales, research and
Background
Quotas for Schedule I and II Controlled product development requirements, and
The DEA established the initial 2015 the additional quota applications
Substances and Assessment of
aggregate production quotas for received. Upon consideration of the
Annual Needs for the List I Chemicals
controlled substances in schedules I and above, the Administrator determined
Ephedrine, Pseudoephedrine, and II and the assessment of annual needs
Phenylpropanolamine for 2015 that the proposed adjusted 2015
for the list I chemicals ephedrine, aggregate production quotas for
AGENCY: Drug Enforcement pseudoephedrine, and dihydroetorphine, ethylmorphine,
Administration, Department of Justice. phenylpropanolamine on September 8, etorphine HCl, racemethorphan,
ACTION: Final order. 2014. 79 FR 53216. That notice stated racemorphan, methylphenidate, and
that the DEA could adjust, as needed, oxycodone (for sale) required additional
SUMMARY: This final order establishes the established aggregate production consideration and hereby further adjusts
the final adjusted 2015 aggregate quotas and assessment of annual needs the proposed 2015 aggregate production
production quotas for controlled in accordance with 21 CFR 1303.13 and quotas for these substances. Regarding
substances in schedules I and II of the 21 CFR 1315.13. The proposed adjusted codeine (for sale), fentanyl, gamma
Controlled Substances Act and the 2015 aggregate production quotas for hydroxybutric acid, hydrocodone (for
assessment of annual needs for the list controlled substances in schedules I and sale), methadone, methadone
I chemicals ephedrine, II and assessment of annual needs for intermediate, morphine (for
pseudoephedrine, and the list I chemicals ephedrine, conversion), oripavine, oxymorphone
phenylpropanolamine. pseudoephedrine, and (for conversion), and oxymorphone (for
phenylpropanolamine were sale) the Administrator hereby
DATES: This order is effective September
subsequently published in the Federal determines that the proposed adjusted
16, 2015. Register on July 8, 2015, 80 FR 39156, 2015 aggregate production quotas for
FOR FURTHER INFORMATION CONTACT: John in consideration of the outlined criteria. these substances as published in the
R. Scherbenske, Office of Diversion All interested persons were invited to Federal Register on July 8, 2015, 80 FR
Control, Drug Enforcement comment on or object to the proposed 39156, are sufficient to meet the current
Administration, 8701 Morrissette Drive, adjusted 2015 aggregate production 2015 estimated medical, scientific,
Springfield, Virginia 22152; Telephone: quotas and assessment of annual needs research, and industrial needs of the
(202) 598–6812. on or before August 7, 2015. United States and to provide for
SUPPLEMENTARY INFORMATION: adequate reserve stock.
Analysis for Final Adjusted 2015
Legal Authority As described in the previously
Aggregate Production Quotas and
published notice establishing the 2015
The Drug Enforcement Assessment of Annual Needs
aggregate production quotas and
Administration (DEA) implements and Consideration has been given to the assessment of annual needs, the DEA
enforces titles II and III of the criteria outlined in the July 8, 2015, has specifically considered that
Comprehensive Drug Abuse Prevention notice of proposed adjusted aggregate inventory allowances granted to
and Control Act of 1970, as amended. 21 production quotas and assessment of individual manufacturers may not
U.S.C. 801–971. Titles II and III are annual needs, 80 FR 39156, in always result in the availability of
referred to as the ‘‘Controlled accordance with 21 CFR 1303.13 and 21 sufficient quantities to maintain an
Substances Act’’ and the ‘‘Controlled CFR 1315.13. Five companies submitted adequate reserve stock pursuant to 21
Substances Import and Export Act,’’ timely comments regarding twelve U.S.C. 826(a), as intended. See 21 CFR
respectively, and are collectively schedule I and II controlled substances. 1303.24. This would be concerning if a
referred to as the ‘‘Controlled These comments suggested that the natural disaster or other unforeseen
Substances Act’’ or the ‘‘CSA’’ for the proposed adjusted aggregate production event resulted in substantial disruption
purposes of this action. The DEA quotas for codeine (for sale), fentanyl, to the amount of controlled substances
publishes the implementing regulations gamma hydroxybutric acid, available to provide for legitimate
for these statutes in title 21 of the Code hydrocodone (for sale), methadone, public need. As such, the DEA included
of Federal Regulations (CFR), chapter II. methadone intermediate, in all schedule II aggregate production
asabaliauskas on DSK7TPTVN1PROD with NOTICES
The CSA and its implementing methylphenidate, morphine (for quotas, and certain schedule I aggregate
regulations are designed to prevent, conversion), oripavine, oxycodone (for production quotas, an additional 25% of
detect, and eliminate the diversion of sale), oxymorphone (for conversion), the estimated medical, scientific, and
controlled substances and listed and oxymorphone (for sale) were research needs as part of the amount
chemicals into the illicit market while insufficient to provide for the estimated necessary to ensure the establishment
providing for the legitimate medical, medical, scientific, research, and and maintenance of reserve stocks. The
scientific, research, and industrial needs industrial needs of the United States, for final established aggregate production
of the United States. Controlled export requirements, and for the quotas will reflect these included
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methanone (XLR11) ............................................................... 25
[1-(5-fluoropentyl)-1H-indazol-3-yl](naphthalen-1-yl)methanone (THJ–2201) ............................................................................... 15
1-(1,3-Benzodioxol-5-yl)-2-(methylamino)butan-1-one (butylone) ................................................................................................. 25
1-(1,3-Benzodioxol-5-yl)-2-(methylamino)pentan-1-one (pentylone) ............................................................................................. 25
1-(1-Phenylcyclohexyl)pyrrolidine .................................................................................................................................................. 10
1-(5-Fluoropentyl)-3-(1-naphthoyl)indole (AM2201) ...................................................................................................................... 45
1-(5-Fluoropentyl)-3-(2-iodobenzoyl)indole (AM694) ..................................................................................................................... 45
1-[1-(2-Thienyl)cyclohexyl]piperidine ............................................................................................................................................. 15
1-[2-(4-Morpholinyl)ethyl]-3-(1-naphthoyl)indole (JWH–200) ........................................................................................................ 45
1-Butyl-3-(1-naphthoyl)indole (JWH–073) ..................................................................................................................................... 45
1-Cyclohexylethyl-3-(2-methoxyphenylacetyl)indole (SR–18 and RCS–8) ................................................................................... 45
1-Hexyl-3-(1-naphthoyl)indole (JWH–019) .................................................................................................................................... 45
1-Methyl-4-phenyl-4-propionoxypiperidine ..................................................................................................................................... 2
1-Pentyl-3-(1-naphthoyl)indole (JWH–018 and AM678) ............................................................................................................... 45
1-Pentyl-3-(2-chlorophenylacetyl)indole (JWH–203) ..................................................................................................................... 45
1-Pentyl-3-(2-methoxyphenylacetyl)indole (JWH–250) ................................................................................................................. 45
1-Pentyl-3-(4-chloro-1-naphthoyl)indole (JWH–398) ..................................................................................................................... 45
1-Pentyl-3-(4-methyl-1-naphthoyl)indole (JWH–122) .................................................................................................................... 45
1-Pentyl-3-[(4-methoxy)-benzoyl]indole (SR–19, RCS–4) ............................................................................................................. 45
1-Pentyl-3-[1-(4-methoxynaphthoyl)]indole (JWH–081) ................................................................................................................ 45
2-(2,5-Dimethoxy-4-n-propylphenyl)ethanamine (2C–P) ............................................................................................................... 30
2-(2,5-Dimethoxy-4-ethylphenyl)ethanamine (2C–E) .................................................................................................................... 30
2-(2,5-Dimethoxy-4-methylphenyl)ethanamine (2C–D) ................................................................................................................. 30
2-(2,5-Dimethoxy-4-nitro-phenyl)ethanamine (2C–N) ................................................................................................................... 30
2-(2,5-Dimethoxyphenyl)ethanamine (2C–H) ................................................................................................................................ 30
2-(4-Bromo-2,5-dimethoxyphenyl)-N-(2-methoxybenzyl)ethanamine (25B–NBOMe; 2C–B–NBOMe; 25B; Cimbi-36) ................ 25
2-(4-Chloro-2,5-dimethoxyphenyl)ethanamine (2C–C) .................................................................................................................. 30
2-(4-Chloro-2,5-dimethoxyphenyl)-N-(2-methoxybenzyl)ethanamine (25C–NBOMe; 2C–C–NBOMe; 25C; Cimbi-82) ............... 25
2-(4-Iodo-2,5-dimethoxyphenyl)ethanamine (2C–I) ....................................................................................................................... 30
2-(4-Iodo-2,5-dimethoxyphenyl)-N-(2-methoxybenzyl)ethanamine (25I–NBOMe; 2C–I–NBOMe; 25I; Cimbi-5) .......................... 15
2-(Methylamino)-1-phenylpentan-1-one (pentedrone) ................................................................................................................... 15
2,5-Dimethoxy-4-ethylamphetamine (DOET) ................................................................................................................................ 25
2,5-Dimethoxy-4-n-propylthiophenethylamine ............................................................................................................................... 25
2,5-Dimethoxyamphetamine .......................................................................................................................................................... 25
2-[4-(Ethylthio)-2,5-dimethoxyphenyl]ethanamine (2C–T–2) ......................................................................................................... 30
2-[4-(Isopropylthio)-2,5-dimethoxyphenyl]ethanamine (2C–T–4) .................................................................................................. 30
3,4,5-Trimethoxyamphetamine ...................................................................................................................................................... 25
3,4-Methylenedioxyamphetamine (MDA) ...................................................................................................................................... 55
3,4-Methylenedioxymethamphetamine (MDMA) ........................................................................................................................... 50
3,4-Methylenedioxy-N-ethylamphetamine (MDEA) ....................................................................................................................... 40
3,4-Methylenedioxy-N-methylcathinone (methylone) .................................................................................................................... 50
3,4-Methylenedioxypyrovalerone (MDPV) ..................................................................................................................................... 35
3-Fluoro-N-methylcathinone (3–FMC) ........................................................................................................................................... 25
3-Methylfentanyl ............................................................................................................................................................................. 2
3-Methylthiofentanyl ....................................................................................................................................................................... 2
4-Bromo-2,5-dimethoxyamphetamine (DOB) ................................................................................................................................ 25
4-Bromo-2,5-dimethoxyphenethylamine (2–CB) ........................................................................................................................... 25
4-Fluoro-N-methylcathinone (4–FMC) ........................................................................................................................................... 25
4-Methoxyamphetamine ................................................................................................................................................................ 100
4-Methyl-2,5-dimethoxyamphetamine (DOM) ................................................................................................................................ 25
4-Methylaminorex .......................................................................................................................................................................... 25
asabaliauskas on DSK7TPTVN1PROD with NOTICES
4-Methyl-N-ethylcathinone (4–MEC) ............................................................................................................................................. 25
4-Methyl-N-methylcathinone (mephedrone) .................................................................................................................................. 45
4-Methyl-a-pyrrolidinopropiophenone (4-MePPP) ......................................................................................................................... 25
5-(1,1-Dimethylheptyl)-2-[(1R,3S)-3-hydroxycyclohexyl]-phenol ................................................................................................... 68
5-(1,1-Dimethyloctyl)-2-[(1R,3S)-3-hydroxycyclohexyl]-phenol (cannabicyclohexanol or CP–47,497 C8-homolog) .................... 53
5-Methoxy-3,4-methylenedioxyamphetamine ................................................................................................................................ 25
5-Methoxy-N,N-diisopropyltryptamine ............................................................................................................................................ 25
5-Methoxy-N,N-dimethyltryptamine ............................................................................................................................................... 25
Acetyl-alpha-methylfentanyl ........................................................................................................................................................... 2
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![Federal Register / Vol. 80, No. 179 / Wednesday, September 16, 2015 / Notices 55645
Final adjusted
Basic class 2015 quotas
(g)
Trimeperidine ................................................................................................................................................................................. 2
Schedule II
1-Phenylcyclohexylamine .............................................................................................................................................................. 5
1-Piperidinocyclohexanecarbonitrile .............................................................................................................................................. 5
4-Anilino-N-phenethyl-4-piperidine (ANPP) ................................................................................................................................... 2,687,500
Alfentanil ........................................................................................................................................................................................ 17,750
Alphaprodine .................................................................................................................................................................................. 3
Amobarbital .................................................................................................................................................................................... 25,125
Amphetamine (for conversion) ...................................................................................................................................................... 21,875,000
Amphetamine (for sale) ................................................................................................................................................................. 37,500,000
Carfentanil ...................................................................................................................................................................................... 19
Cocaine .......................................................................................................................................................................................... 275,000
Codeine (for conversion) ............................................................................................................................................................... 50,000,000
Codeine (for sale) .......................................................................................................................................................................... 63,900,000
Dextropropoxyphene ...................................................................................................................................................................... 45
Dihydrocodeine .............................................................................................................................................................................. 226,375
Dihydroetorphine ............................................................................................................................................................................ 3
Diphenoxylate (for conversion) ...................................................................................................................................................... 75,000
Diphenoxylate (for sale) ................................................................................................................................................................. 1,337,500
Ecgonine ........................................................................................................................................................................................ 174,375
Ethylmorphine ................................................................................................................................................................................ 5
Etorphine hydrochloride ................................................................................................................................................................. 3
Fentanyl ......................................................................................................................................................................................... 2,300,000
Glutethimide ................................................................................................................................................................................... 3
Hydrocodone (for conversion) ....................................................................................................................................................... 137,500
Hydrocodone (for sale) .................................................................................................................................................................. 99,625,000
Hydromorphone ............................................................................................................................................................................. 7,000,000
Isomethadone ................................................................................................................................................................................ 5
Levo-alphacetylmethadol (LAAM) .................................................................................................................................................. 4
Levomethorphan ............................................................................................................................................................................ 30
Levorphanol ................................................................................................................................................................................... 7,125
Lisdexamfetamine .......................................................................................................................................................................... 29,750,000
Meperidine ..................................................................................................................................................................................... 6,250,000
Meperidine Intermediate-A ............................................................................................................................................................ 6
Meperidine Intermediate-B ............................................................................................................................................................ 32
Meperidine Intermediate-C ............................................................................................................................................................ 6
Metazocine ..................................................................................................................................................................................... 19
Methadone (for sale) ..................................................................................................................................................................... 31,875,000
Methadone Intermediate ................................................................................................................................................................ 34,375,000
Methamphetamine ......................................................................................................................................................................... 2,061,375
[1,250,000 grams of levo-desoxyephedrine for use in a non-controlled, non-prescription product; 750,000 grams for methamphetamine
mostly for conversion to a schedule III product; and 61,375 grams for methamphetamine (for sale)]
Methylphenidate ............................................................................................................................................................................. 96,750,000
Morphine (for conversion) .............................................................................................................................................................. 91,250,000
Morphine (for sale) ........................................................................................................................................................................ 62,500,000
Nabilone ......................................................................................................................................................................................... 18,750
Noroxymorphone (for conversion) ................................................................................................................................................. 17,500,000
Noroxymorphone (for sale) ............................................................................................................................................................ 1,475,000
Opium (powder) ............................................................................................................................................................................. 112,500
Opium (tincture) ............................................................................................................................................................................. 687,500
Oripavine ........................................................................................................................................................................................ 35,000,000
Oxycodone (for conversion) .......................................................................................................................................................... 8,350,000
Oxycodone (for sale) ..................................................................................................................................................................... 141,375,000
Oxymorphone (for conversion) ...................................................................................................................................................... 29,000,000
Oxymorphone (for sale) ................................................................................................................................................................. 7,750,000
Pentobarbital .................................................................................................................................................................................. 35,000,000
Phenazocine .................................................................................................................................................................................. 6
Phencyclidine ................................................................................................................................................................................. 38
Phenmetrazine ............................................................................................................................................................................... 3
asabaliauskas on DSK7TPTVN1PROD with NOTICES
Phenylacetone ............................................................................................................................................................................... 9,375,000
Racemethorphan ........................................................................................................................................................................... 5
Racemorphan ................................................................................................................................................................................ 3
Remifentanil ................................................................................................................................................................................... 4,200
Secobarbital ................................................................................................................................................................................... 215,003
Sufentanil ....................................................................................................................................................................................... 6,255
Tapentadol ..................................................................................................................................................................................... 12,500,000
Thebaine ........................................................................................................................................................................................ 125,000,000
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![55646 Federal Register / Vol. 80, No. 179 / Wednesday, September 16, 2015 / Notices
Final adjusted
Basic class 2015 quotas
(g)
List I Chemicals
Ephedrine (for conversion) ............................................................................................................................................................ 1,000,000
Ephedrine (for sale) ....................................................................................................................................................................... 4,000,000
Phenylpropanolamine (for conversion) .......................................................................................................................................... 44,800,000
Phenylpropanolamine (for sale) ..................................................................................................................................................... 8,500,000
Pseudoephedrine (for conversion) ................................................................................................................................................ 7,000
Pseudoephedrine (for sale) ........................................................................................................................................................... 224,500,000
Aggregate production quotas for all before such rate is to take effect. See 79 engaging in notice-and-comment
other schedule I and II controlled FR 9851. rulemaking, the Department published a
substances included in 21 CFR 1308.11 Pursuant to Executive Order 13658 Final Rule on October 7, 2014 to
and 1308.12 remain at zero. and its implementing regulations at 29 implement the Executive Order. See 79
Dated: September 10, 2015. CFR part 10, notice is hereby given that FR 60634. The final regulations, set
Chuck Rosenberg,
beginning January 1, 2016, the forth at 29 CFR part 10, established
Executive Order minimum wage rate standards and procedures for
Acting Administrator.
that generally must be paid to workers implementing and enforcing the
[FR Doc. 2015–23199 Filed 9–15–15; 8:45 am]
performing work on or in connection minimum wage protections of the
BILLING CODE 4410–09–P
with covered contracts is $10.15 per Order.
hour. Notice is also hereby given that, The Executive Order and its
beginning January 1, 2016, the required implementing regulations require the
DEPARTMENT OF LABOR minimum cash wage that generally must Secretary to determine the applicable
be paid to tipped employees performing minimum wage rate to be paid to
Office of the Secretary workers performing work on or in
work on or in connection with covered
Establishing a Minimum Wage for contracts is $5.85 per hour. connection with covered contracts on an
Contractors, Notice of Rate Change in DATES: This notice is effective on annual basis, beginning January 1, 2016.
Effect as of January 1, 2016 September 16, 2015. See 79 FR 9851; 29 CFR 10.1(a)(2),
FOR FURTHER INFORMATION CONTACT:
10.5(a)(2), 10.12(a). Sections 2(a) and (b)
AGENCY: Wage and Hour Division, Robert Waterman, Acting Director, of the Order establish the methodology
Department of Labor. Division of Regulations, Legislation, and that the Secretary must use to determine
ACTION: Notice. Interpretation, Wage and Hour Division, the annual inflation-based increases to
the minimum wage rate. See 79 FR
SUMMARY: The Wage and Hour Division U.S. Department of Labor, Room S–
9851. These provisions, which are
(WHD) of the U.S. Department of Labor 3502, 200 Constitution Avenue NW.,
implemented in 29 CFR 10.5(b), explain
(the Department) is issuing this notice to Washington, DC 20210; telephone: (202)
that the applicable minimum wage
announce the applicable minimum 693–0406 (this is not a toll-free
determined by the Secretary for each
wage rate to be paid to workers number). Copies of this notice may be
calendar year shall be:
performing work on or in connection obtained in alternative formats (Large (i) Not less than the amount in effect
with Federal contracts covered by Print, Braille, Audio Tape, or Disc), on the date of such determination;
Executive Order 13658, beginning upon request, by calling (202) 693–0023 (ii) Increased from such amount by
January 1, 2016. (not a toll-free number). TTY/TTD the annual percentage increase in the
Executive Order 13658, Establishing a callers may dial toll-free (877) 889–5627 Consumer Price Index for Urban Wage
Minimum Wage for Contractors (the to obtain information or request Earners and Clerical Workers (CPI–W)
Executive Order or the Order), was materials in alternative formats. (United States city average, all items,
signed by President Barack Obama on SUPPLEMENTARY INFORMATION: not seasonally adjusted), or its successor
February 12, 2014, and raised the hourly publication, as determined by the
I. Executive Order 13658 Background
minimum wage paid by contractors to Bureau of Labor Statistics (BLS); and
and Requirements for Determining
workers performing work on covered (iii) Rounded to the nearest multiple
Federal contracts to: $10.10 per hour, Annual Increases to the Minimum
of $0.05.
beginning January 1, 2015; and Wage Rate
Section 2(b) of the Executive Order
beginning January 1, 2016, and annually Executive Order 13658 was signed by further provides that, in calculating the
thereafter, an amount determined by the President Barack Obama on February annual percentage increase in the CPI
Secretary of Labor (the Secretary) in 12, 2014, and raised the hourly for purposes of determining the new
accordance with the methodology set minimum wage paid by contractors to minimum wage rate, the Secretary shall
forth in the Order. See 79 FR 9851. The workers performing work on or in compare such CPI for the most recent
Secretary’s determination of the connection with covered Federal month, quarter, or year available (as
Executive Order minimum wage rate contracts to $10.10 per hour, beginning selected by the Secretary prior to the
asabaliauskas on DSK7TPTVN1PROD with NOTICES
also affects the minimum hourly cash January 1, 2015; and beginning January first year for which a minimum wage is
wage that must be paid to tipped 1, 2016, and annually thereafter, an in effect) with the CPI for the same
employees performing work on or in amount determined by the Secretary month in the preceding year, the same
connection with covered contracts pursuant to the Order. See 79 FR 9851. quarter in the preceding year, or the
beginning January 1, 2016. See 79 FR The Executive Order directed the preceding year, respectively. See 79 FR
9851–52. The Secretary is required to Secretary to issue regulations to 9851. In order to calculate the annual
provide notice to the public of the new implement the Order’s requirements. percentage increase in the CPI, the
minimum wage rate at least 90 days See 79 FR 9852. Accordingly, after Department elected in its Final Rule
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Document Created: 2018-02-26 10:16:35
Document Modified: 2018-02-26 10:16:35
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Action | Final order. | |
| Dates | This order is effective September 16, 2015. | |
| Contact | John R. Scherbenske, Office of Diversion Control, Drug Enforcement Administration, 8701 Morrissette Drive, Springfield, Virginia 22152; Telephone: (202) 598-6812. | |
| FR Citation | 80 FR 55642 |
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