80 FR 39156 - Proposed Adjustments to the 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 130 (July 8, 2015)
Drug Enforcement Administration
Federal Register Volume 80, Issue 130 (July 8, 2015)
| Page Range | 39156-39160 | |
| FR Document | 2015-16699 |
[Federal Register Volume 80, Number 130 (Wednesday, July 8, 2015)] [Notices] [Pages 39156-39160] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2015-16699] ======================================================================= ----------------------------------------------------------------------- DEPARTMENT OF JUSTICE Drug Enforcement Administration [Docket No. DEA-418P] Proposed Adjustments to the Aggregate Production Quotas for Schedule I and II Controlled Substances and Assessment of Annual Needs for the List I Chemicals Ephedrine, Pseudoephedrine, and Phenylpropanolamine for 2015 AGENCY: Drug Enforcement Administration, Department of Justice. ACTION: Notice with request for comments. ----------------------------------------------------------------------- SUMMARY: The Drug Enforcement Administration proposes to adjust the 2015 aggregate production quotas for several 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: Interested persons may file written comments on this notice in accordance with 21 CFR 1303.13(c) and 1315.13(d). Electronic comments must be submitted, and written comments must be postmarked, on or before August 7, 2015. Commenters should be aware that the electronic Federal Docket Management System will not accept comments after 11:59 p.m. Eastern Time on the last day of the comment period. ADDRESSES: To ensure proper handling of comments, please reference ``Docket No. DEA-418P'' on all correspondence, including any attachments. The Drug Enforcement Administration encourages that all comments be submitted electronically through the Federal eRulemaking Portal which provides the ability to type short comments directly into the comment field on the Web page or attach a file for lengthier comments. Please go to http://www.regulations.gov and follow the online instructions at that site for submitting comments. Upon completion of your submission you will receive a Comment Tracking Number for your comment. Please be aware that submitted comments are not instantaneously available for public view on Regulations.gov. If you have received a Comment Tracking Number, your comment has been successfully submitted and there is no need to resubmit the same comment. Paper comments that duplicate electronic submissions are not necessary and are discouraged. Should you wish to mail a paper comment in lieu of an electronic comment, it should be sent via regular or express mail to: Drug Enforcement Administration, Attention: DEA Federal Register Representative/ODL, 8701 Morrissette Drive, Springfield, Virginia 22152. 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: Posting of Public Comments Please note that all comments received in response to this docket are considered part of the public record and will be made available for public inspection online at http://www.regulations.gov. Such information includes personal identifying information (such as your name, address, etc.) voluntarily submitted by the commenter. The Freedom of Information Act (FOIA) applies to all comments received. If you want to submit personal identifying information (such as your name, address, etc.) as part of your comment, but do not want it to be 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 made publicly available 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 made publicly available, you must include the phrase ``CONFIDENTIAL BUSINESS INFORMATION'' in the first paragraph of your comment. You must also prominently identify the confidential business information to be redacted within the comment. If a comment has so much confidential business information that it cannot be effectively redacted, all or part of that comment may not be made available in the public docket. Comments containing personal identifying information or confidential business information identified as directed above will be made publicly available in redacted form. An electronic copy of this document is available at http://www.regulations.gov for easy reference. Legal Authority and Background Section 306 of the Controlled Substances Act (CSA), 21 U.S.C. 826, requires the Attorney General to determine the total quantity and establish aggregate production quotas for each basic class of controlled substance listed in schedules I and II and for the list I chemicals ephedrine, pseudoephedrine, and phenylpropanolamine. This responsibility has been delegated to the Administrator of the DEA. 28 CFR 0.100(b). The DEA established the 2015 aggregate production quotas for 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 stipulated that, in accordance with 21 CFR 1303.13 and 1315.13, all aggregate production quotas and assessments of annual need are subject to adjustment. Analysis for Proposed Adjusted 2015 Aggregate Production Quotas and Assessment of Annual Needs The DEA proposes to adjust the established 2015 aggregate production quotas for certain schedule I and II controlled substances to be manufactured in the United States in 2015 to provide for the estimated medical, scientific, research, and industrial needs of the United States, 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. The DEA is not proposing to adjust the established 2015 assessment of annual needs for the list I chemicals ephedrine, pseudoephedrine, and phenylpropanolamine to be manufactured in and imported into the United States in 2015 to provide for the estimated medical, scientific, research, and industrial needs of the United States, lawful export requirements, and the establishment and maintenance of reserve stocks. In proposing the adjustment, the DEA has taken into account the criteria that the DEA is required to consider in accordance with 21 CFR 1303.13 and 21 CFR 1315.13. The DEA determines whether to propose an adjustment of the aggregate production quotas for basic classes of schedule I and II controlled substances and assessment of annual needs for ephedrine, pseudoephedrine, [[Page 39157]] and phenylpropanolamine by considering: (1) Changes in the demand for that class or chemical, changes in the national rate of net disposal of the class or chemical, and changes in the rate of net disposal of the class or chemical by registrants holding individual manufacturing quotas for the class; (2) whether any increased demand for that class or chemical, the national and/or individual rates of net disposal of that class or chemical are temporary, short term, or long term; (3) whether any increased demand for that class or chemical can be met through existing inventories, increased individual manufacturing quotas, or increased importation, without increasing the aggregate production quota; (4) whether any decreased demand for that class or chemical will result in excessive inventory accumulation by all persons registered to handle that class or chemical; and (5) other factors affecting medical, scientific, research, and industrial needs in the United States and lawful export requirements, as the Acting Administrator finds relevant. The DEA also considered updated information obtained from 2014 year-end inventories, 2014 disposition data submitted by quota applicants, estimates of the medical needs of the United States, product development, and other information made available to the DEA after the initial aggregate production quotas and assessment of annual needs had been established. Other factors the DEA considered in calculating the aggregate production quotas, but not the assessment of annual needs, include product development requirements of both bulk and finished dosage form manufacturers, and other pertinent information. In determining the proposed adjusted 2015 assessment of annual needs, the DEA used the calculation methodology previously described in the 2010 and 2011 established assessment of annual needs (74 FR 60294, Nov. 20, 2009, and 75 FR 79407, Dec. 20, 2010, respectively). As previously described in the 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, 21 CFR 1303.24, 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. This would be concerning if a natural disaster or other unforeseen event resulted in substantial disruption to the amount of controlled substances available to provide for legitimate public need. As such, the DEA has included in all proposed adjusted schedule II controlled substance aggregate production quotas, and certain proposed adjusted schedule I controlled substance aggregate production quotas, an additional 25% of the estimated medical, scientific, and research needs as part of the amount necessary to ensure the establishment and maintenance of reserve stocks. The resulting adjusted established aggregate production quotas will reflect these included amounts. This action will not affect the ability of manufacturers to maintain inventory allowances as specified by regulation. The DEA 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. The Acting Administrator, therefore, proposes to adjust the 2015 aggregate production quotas for certain schedule I and II controlled substances expressed in grams of anhydrous acid or base, as follows: ---------------------------------------------------------------------------------------------------------------- Established 2015 Proposed Adjusted 2015 Quotas Quotas --------------------------------------- Basic class ------------------- (g) (g) ---------------------------------------------------------------------------------------------------------------- Schedule I ---------------------------------------------------------------------------------------------------------------- (1-Pentyl-1H-indol-3-yl)(2,2,3,3- 15 25 tetramethylcyclopropyl)methanone (UR-144). [1-(5-Fluoro-pentyl)-1H-indol-3-yl](2,2,3,3- 15 25 tetramethylcyclopropyl)methanone (XLR11). [1-(5-fluoropentyl)-1H-indazol-3-yl](naphthalen-1- 15 no change yl)methanone (THJ-2201). 1-(1,3-Benzodioxol-5-yl)-2-(methylamino)butan-1-one 15 25 (butylone). 1-(1,3-Benzodioxol-5-yl)-2-(methylamino)pentan-1-one 15 25 (pentylone). 1-(1-Phenylcyclohexyl)pyrrolidine.................... 10 no change 1-(5-Fluoropentyl)-3-(1-naphthoyl)indole (AM2201).... 45 no change 1-(5-Fluoropentyl)-3-(2-iodobenzoyl)indole (AM694)... 45 no change 1-[1-(2-Thienyl)cyclohexyl]piperidine................ 15 no change 1-[2-(4-Morpholinyl)ethyl]-3-(1-naphthoyl)indole (JWH- 45 no change 200). 1-Butyl-3-(1-naphthoyl)indole (JWH-073).............. 45 no change 1-Cyclohexylethyl-3-(2-methoxyphenylacetyl)indole (SR- 45 no change 18 and RCS-8). 1-Hexyl-3-(1-naphthoyl)indole (JWH-019).............. 45 no change 1-Methyl-4-phenyl-4-propionoxypiperidine............. 2 no change 1-Pentyl-3-(1-naphthoyl)indole (JWH-018 and AM678)... 45 no change 1-Pentyl-3-(2-chlorophenylacetyl)indole (JWH-203).... 45 no change 1-Pentyl-3-(2-methoxyphenylacetyl)indole (JWH-250)... 45 no change 1-Pentyl-3-(4-chloro-1-naphthoyl)indole (JWH-398).... 45 no change 1-Pentyl-3-(4-methyl-1-naphthoyl)indole (JWH-122).... 45 no change 1-Pentyl-3-[(4-methoxy)-benzoyl]indole (SR-19, RCS-4) 45 no change 1-Pentyl-3-[1-(4-methoxynaphthoyl)]indole (JWH-081).. 45 no change 2-(2,5-Dimethoxy-4-n-propylphenyl)ethanamine (2C-P).. 30 no change 2-(2,5-Dimethoxy-4-ethylphenyl)ethanamine (2C-E)..... 30 no change 2-(2,5-Dimethoxy-4-methylphenyl)ethanamine (2C-D).... 30 no change 2-(2,5-Dimethoxy-4-nitro-phenyl)ethanamine (2C-N).... 30 no change 2-(2,5-Dimethoxyphenyl)ethanamine (2C-H)............. 30 no change 2-(4-Bromo-2,5-dimethoxyphenyl)-N-(2- 15 25 methoxybenzyl)ethanamine (25B-NBOMe; 2C-B-NBOMe; 25B; Cimbi-36). 2-(4-Chloro-2,5-dimethoxyphenyl)ethanamine (2C-C).... 30 no change [[Page 39158]] 2-(4-Chloro-2,5-dimethoxyphenyl)-N-(2- 15 25 methoxybenzyl)ethanamine (25C-NBOMe; 2C-C-NBOMe; 25C; Cimbi-82). 2-(4-Iodo-2,5-dimethoxyphenyl)ethanamine (2C-I)...... 30 no change 2-(4-Iodo-2,5-dimethoxyphenyl)-N-(2- 15 no change methoxybenzyl)ethanamine (25I-NBOMe; 2C-I-NBOMe; 25I; Cimbi-5). 2-(Methylamino)-1-phenylpentan-1-one (pentedrone).... 15 no change 2,5-Dimethoxy-4-ethylamphetamine (DOET).............. 25 no change 2,5-Dimethoxy-4-n-propylthiophenethylamine........... 25 no change 2,5-Dimethoxyamphetamine............................. 25 no change 2-[4-(Ethylthio)-2,5-dimethoxyphenyl]ethanamine (2C-T- 30 no change 2). 2-[4-(Isopropylthio)-2,5-dimethoxyphenyl]ethanamine 30 no change (2C-T-4). 3,4,5-Trimethoxyamphetamine.......................... 25 no change 3,4-Methylenedioxyamphetamine (MDA).................. 55 no change 3,4-Methylenedioxymethamphetamine (MDMA)............. 50 no change 3,4-Methylenedioxy-N-ethylamphetamine (MDEA)......... 40 no change 3,4-Methylenedioxy-N-methylcathinone (methylone)..... 50 no change 3,4-Methylenedioxypyrovalerone (MDPV)................ 35 no change 3-Fluoro-N-methylcathinone (3-FMC)................... 15 25 3-Methylfentanyl..................................... 2 no change 3-Methylthiofentanyl................................. 2 no change 4-Bromo-2,5-dimethoxyamphetamine (DOB)............... 25 no change 4-Bromo-2,5-dimethoxyphenethylamine (2-CB)........... 25 no change 4-Fluoro-N-methylcathinone (4-FMC)................... 15 25 4-Methoxyamphetamine................................. 100 no change 4-Methyl-2,5-dimethoxyamphetamine (DOM).............. 25 no change 4-Methylaminorex..................................... 25 no change 4-Methyl-N-ethylcathinone (4-MEC).................... 15 25 4-Methyl-N-methylcathinone (mephedrone).............. 45 no change 4-Methyl-[alpha]-pyrrolidinopropiophenone (4-MePPP).. 15 25 5-(1,1-Dimethylheptyl)-2-[(1R,3S)-3- 68 no change hydroxycyclohexyl]-phenol. 5-(1,1-Dimethyloctyl)-2-[(1R,3S)-3-hydroxycyclohexyl]- 53 no change phenol (cannabicyclohexanol or CP-47,497 C8-homolog). 5-Methoxy-3,4-methylenedioxyamphetamine.............. 25 no change 5-Methoxy-N,N-diisopropyltryptamine.................. 25 no change 5-Methoxy-N,N-dimethyltryptamine..................... 25 no change Acetyl-alpha-methylfentanyl.......................... 2 no change Acetyldihydrocodeine................................. 2 no change Acetylmethadol....................................... 2 no change Allylprodine......................................... 2 no change Alphacetylmethadol................................... 2 no change alpha-Ethyltryptamine................................ 25 no change Alphameprodine....................................... 2 no change Alphamethadol........................................ 2 no change alpha-Methylfentanyl................................. 2 no change alpha-Methylthiofentanyl............................. 2 no change alpha-Methyltryptamine (AMT)......................... 25 no change alpha-Pyrrolidinobutiophenone ([alpha]-PBP).......... 15 25 alpha-Pyrrolidinopentiophenone ([alpha]-PVP)......... 15 25 Aminorex............................................. 25 no change Benzylmorphine....................................... 2 no change Betacetylmethadol.................................... 2 no change beta-Hydroxy-3-methylfentanyl........................ 2 no change beta-Hydroxyfentanyl................................. 2 no change Betameprodine........................................ 2 no change Betamethadol......................................... 4 no change Betaprodine.......................................... 2 no change Bufotenine........................................... 3 no change Cathinone............................................ 70 no change Codeine methylbromide................................ 5 no change Codeine-N-oxide...................................... 305 no change Desomorphine......................................... 5 25 Diethyltryptamine.................................... 25 no change Difenoxin............................................ 11,000 no change Dihydromorphine...................................... 3,990,000 no change Dimethyltryptamine................................... 35 no change Dipipanone........................................... 5 no change Fenethylline......................................... 5 no change gamma-Hydroxybutyric acid............................ 70,250,000 no change Heroin............................................... 25 50 Hydromorphinol....................................... 2 no change [[Page 39159]] Hydroxypethidine..................................... 2 no change Ibogaine............................................. 5 no change Lysergic acid diethylamide (LSD)..................... 35 no change Marihuana............................................ 658,000 no change Mescaline............................................ 25 no change Methaqualone......................................... 10 no change Methcathinone........................................ 25 no change Methyldesorphine..................................... 5 no change Methyldihydromorphine................................ 2 no change Morphine methylbromide............................... 5 no change Morphine methylsulfonate............................. 5 no change Morphine-N-oxide..................................... 350 no change N-(1-Adamantyl)-1-pentyl-1H-indazole-3-carboxamide 15 25 (AKB48). N-(1-Amino-3,3-dimethyl-1-oxobutan-2-yl)-1-pentyl-1H- 15 25 indazole-3-carboxamide (ADB-PINACA). N-(1-Amino-3-methyl-1-oxobutan-2-yl)-1-(4- 15 25 fluorobenzyl)-1H-indazole-3-carboxamide (AB- FUBINACA). N-(1-Amino-3-methyl-1-oxobutan-2-yl)-1- 15 no change (cyclohexylmethyl)-1H-indazole-3-carboxamide (AB- CHMINACA). N-(1-Amino-3-methyl-1-oxobutan-2-yl)-1-pentyl-1H- 15 no change indazole-3-carboxamide (AB-PINACA). N,N-Dimethylamphetamine.............................. 25 no change Naphthylpyrovalerone (naphyrone)..................... 15 25 N-Benzylpiperazine................................... 25 no change N-Ethyl-1-phenylcyclohexylamine...................... 5 no change N-Ethylamphetamine................................... 24 no change N-Hydroxy-3,4-methylenedioxyamphetamine.............. 24 no change Noracymethadol....................................... 2 no change Norlevorphanol....................................... 52 no change Normethadone......................................... 2 no change Normorphine.......................................... 18 40 Para-fluorofentanyl.................................. zero 5 Parahexyl............................................ zero 5 Phenomorphan......................................... 2 no change Pholcodine........................................... zero 5 Psilocybin........................................... 30 no change Psilocyn............................................. 30 no change Quinolin-8-yl 1-(5-fluoropentyl)-1H-indole-3- 15 25 carboxylate (5-fluoro-PB-22; 5F-PB-22). Quinolin-8-yl 1-pentyl-1H-indole-3-carboxylate (PB- 15 25 22; QUPIC). Tetrahydrocannabinols................................ 497,500 511,250 Thiofentanyl......................................... 2 no change Tilidine............................................. 10 25 Trimeperidine........................................ 2 no change ---------------------------------------------------------------------------------------------------------------- Schedule II ---------------------------------------------------------------------------------------------------------------- 1-Phenylcyclohexylamine.............................. 5 no change 1-Piperidinocyclohexanecarbonitrile.................. 5 no change 4-Anilino-N-phenethyl-4-piperidine (ANPP)............ 2,687,500 no change Alfentanil........................................... 17,750 no change Alphaprodine......................................... 3 no change Amobarbital.......................................... 25,125 no change Amphetamine (for conversion)......................... 21,875,000 no change Amphetamine (for sale)............................... 37,500,000 no change Carfentanil.......................................... 19 no change Cocaine.............................................. 275,000 no change Codeine (for conversion)............................. 50,000,000 no change Codeine (for sale)................................... 49,500,000 63,900,000 Dextropropoxyphene................................... 19 45 Dihydrocodeine....................................... 226,375 no change Diphenoxylate (for conversion)....................... 75,000 no change Diphenoxylate (for sale)............................. 1,337,500 no change Ecgonine............................................. 174,375 no change Ethylmorphine........................................ 3 no change Fentanyl............................................. 2,150,000 2,300,000 Glutethimide......................................... 3 no change Hydrocodone (for conversion)......................... 137,500 no change Hydrocodone (for sale)............................... 99,625,000 no change Hydromorphone........................................ 7,000,000 no change Isomethadone......................................... 5 no change Levo-alphacetylmethadol (LAAM)....................... 4 no change Levomethorphan....................................... 5 30 Levorphanol.......................................... 7,125 no change [[Page 39160]] Lisdexamfetamine..................................... 29,750,000 no change Meperidine........................................... 6,250,000 no change Meperidine Intermediate-A............................ 6 no change Meperidine Intermediate-B............................ 11 32 Meperidine Intermediate-C............................ 6 no change Metazocine........................................... 19 no change Methadone (for sale)................................. 31,875,000 no change Methadone Intermediate............................... 34,375,000 no change Methamphetamine...................................... 2,061,375 no change ---------------------------------------------------------------------------------------------------------------- [1,250,000 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...................................... 83,750,000 87,500,000 Morphine (for conversion)............................ 91,250,000 no change Morphine (for sale).................................. 62,500,000 no change Nabilone............................................. 18,750 no change Noroxymorphone (for conversion)...................... 17,500,000 no change Noroxymorphone (for sale)............................ 1,475,000 no change Opium (powder)....................................... 112,500 no change Opium (tincture)..................................... 687,500 no change Oripavine............................................ 35,000,000 no change Oxycodone (for conversion)........................... 8,350,000 no change Oxycodone (for sale)................................. 137,500,000 139,150,000 Oxymorphone (for conversion)......................... 29,000,000 no change Oxymorphone (for sale)............................... 7,750,000 no change Pentobarbital........................................ 35,000,000 no change Phenazocine.......................................... 6 no change Phencyclidine........................................ 19 38 Phenmetrazine........................................ 3 no change Phenylacetone........................................ 9,375,000 no change Racemethorphan....................................... 3 no change Remifentanil......................................... 3,750 4,200 Secobarbital......................................... 215,003 no change Sufentanil........................................... 6,255 no change Tapentadol........................................... 12,500,000 no change Thebaine............................................. 125,000,000 no change ---------------------------------------------------------------------------------------------------------------- List I Chemicals ---------------------------------------------------------------------------------------------------------------- Ephedrine (for conversion)........................... 1,000,000 no change Ephedrine (for sale)................................. 4,000,000 no change Phenylpropanolamine (for conversion)................. 44,800,000 no change Phenylpropanolamine (for sale)....................... 8,500,000 no change Pseudoephedrine (for conversion)..................... 7,000 no change Pseudoephedrine (for sale)........................... 224,500,000 no change ---------------------------------------------------------------------------------------------------------------- The Acting Administrator further proposes that aggregate production quotas for all other schedule I and II controlled substances included in 21 CFR 1308.11 and 1308.12 remain at zero. In accordance with 21 CFR 1303.13 and 21 CFR 1315.13, upon consideration of the relevant factors, the Acting Administrator may further adjust the 2015 aggregate production quotas and assessment of annual needs as needed. Comments In accordance with 21 CFR 1303.13(c) and 1315.13(d), any interested person may submit written comments on or objections to these proposed determinations. Based on comments received in response to this notice, the Acting Administrator may hold a public hearing on one or more issues raised. 21 CFR 1303.13(c) and 1315.13(e). In the event the Acting Administrator decides to hold such a hearing, the Acting Administrator will publish a notice of the hearing in the Federal Register. After consideration of any comments or objections, or after a hearing, if one is held, the Acting Administrator will issue and publish in the Federal Register a final order establishing any adjustment of the 2015 aggregate production quota for each basic class of controlled substance and established assessment of annual needs for the list I chemicals ephedrine, pseudoephedrine, and phenylpropanolamine. 21 CFR 1303.13(c) and 1315.13(f). Dated: July 1, 2015. Chuck Rosenberg, Acting Administrator. [FR Doc. 2015-16699 Filed 7-7-15; 8:45 am] BILLING CODE P
![39156 Federal Register / Vol. 80, No. 130 / Wednesday, July 8, 2015 / Notices
Dated: July 1, 2015. submitted and there is no need to An electronic copy of this document
Robert W. Middleton, resubmit the same comment. Paper is available at http://
Deputy Chief, Office of Offshore Regulatory comments that duplicate electronic www.regulations.gov for easy reference.
Programs. submissions are not necessary and are Legal Authority and Background
[FR Doc. 2015–16675 Filed 7–7–15; 8:45 am] discouraged. Should you wish to mail a
BILLING CODE 4310–VH–P paper comment in lieu of an electronic Section 306 of the Controlled
comment, it should be sent via regular Substances Act (CSA), 21 U.S.C. 826,
or express mail to: Drug Enforcement requires the Attorney General to
Administration, Attention: DEA Federal determine the total quantity and
DEPARTMENT OF JUSTICE establish aggregate production quotas
Register Representative/ODL, 8701
Drug Enforcement Administration Morrissette Drive, Springfield, Virginia for each basic class of controlled
22152. substance listed in schedules I and II
[Docket No. DEA–418P] and for the list I chemicals ephedrine,
FOR FURTHER INFORMATION CONTACT: John pseudoephedrine, and
Proposed Adjustments to the R. Scherbenske, Office of Diversion phenylpropanolamine. This
Aggregate Production Quotas for Control, Drug Enforcement responsibility has been delegated to the
Schedule I and II Controlled Administration, 8701 Morrissette Drive, Administrator of the DEA. 28 CFR
Substances and Assessment of Springfield, Virginia 22152, Telephone: 0.100(b).
Annual Needs for the List I Chemicals (202) 598–6812. The DEA established the 2015
Ephedrine, Pseudoephedrine, and aggregate production quotas for
Phenylpropanolamine for 2015 SUPPLEMENTARY INFORMATION: substances in schedules I and II and the
AGENCY: Drug Enforcement Posting of Public Comments assessment of annual needs for the list
Administration, Department of Justice. I chemicals ephedrine,
Please note that all comments pseudoephedrine, and
ACTION: Notice with request for
received in response to this docket are phenylpropanolamine on September 8,
comments.
considered part of the public record and 2014 (79 FR 53216). That notice
SUMMARY: The Drug Enforcement will be made available for public stipulated that, in accordance with 21
Administration proposes to adjust the inspection online at http:// CFR 1303.13 and 1315.13, all aggregate
2015 aggregate production quotas for www.regulations.gov. Such information production quotas and assessments of
several controlled substances in includes personal identifying annual need are subject to adjustment.
schedules I and II of the Controlled information (such as your name, Analysis for Proposed Adjusted 2015
Substances Act and the assessment of address, etc.) voluntarily submitted by Aggregate Production Quotas and
annual needs for the list I chemicals the commenter. Assessment of Annual Needs
ephedrine, pseudoephedrine, and The Freedom of Information Act
phenylpropanolamine. The DEA proposes to adjust the
(FOIA) applies to all comments established 2015 aggregate production
DATES: Interested persons may file received. If you want to submit personal quotas for certain schedule I and II
written comments on this notice in identifying information (such as your controlled substances to be
accordance with 21 CFR 1303.13(c) and name, address, etc.) as part of your manufactured in the United States in
1315.13(d). Electronic comments must comment, but do not want it to be 2015 to provide for the estimated
be submitted, and written comments posted online or made available in the medical, scientific, research, and
must be postmarked, on or before public docket, you must include the industrial needs of the United States,
August 7, 2015. Commenters should be phrase ‘‘PERSONAL IDENTIFYING lawful export requirements, and the
aware that the electronic Federal Docket INFORMATION’’ in the first paragraph establishment and maintenance of
Management System will not accept of your comment. You must also place reserve stocks. These quotas do not
comments after 11:59 p.m. Eastern Time all the personal identifying information include imports of controlled
on the last day of the comment period. you do not want made publicly substances for use in industrial
ADDRESSES: To ensure proper handling available in the first paragraph of your processes. The DEA is not proposing to
of comments, please reference ‘‘Docket comment and identify what information adjust the established 2015 assessment
No. DEA–418P’’ on all correspondence, you want redacted. of annual needs for the list I chemicals
including any attachments. The Drug If you want to submit confidential ephedrine, pseudoephedrine, and
Enforcement Administration encourages business information as part of your phenylpropanolamine to be
that all comments be submitted comment, but do not want it to be made manufactured in and imported into the
electronically through the Federal publicly available, you must include the United States in 2015 to provide for the
eRulemaking Portal which provides the phrase ‘‘CONFIDENTIAL BUSINESS estimated medical, scientific, research,
ability to type short comments directly INFORMATION’’ in the first paragraph and industrial needs of the United
into the comment field on the Web page of your comment. You must also States, lawful export requirements, and
or attach a file for lengthier comments. prominently identify the confidential the establishment and maintenance of
Please go to http://www.regulations.gov business information to be redacted reserve stocks.
and follow the online instructions at within the comment. If a comment has In proposing the adjustment, the DEA
that site for submitting comments. Upon so much confidential business has taken into account the criteria that
completion of your submission you will information that it cannot be effectively the DEA is required to consider in
srobinson on DSK5SPTVN1PROD with NOTICES
receive a Comment Tracking Number for redacted, all or part of that comment accordance with 21 CFR 1303.13 and 21
your comment. Please be aware that may not be made available in the public CFR 1315.13. The DEA determines
submitted comments are not docket. Comments containing personal whether to propose an adjustment of the
instantaneously available for public identifying information or confidential aggregate production quotas for basic
view on Regulations.gov. If you have business information identified as classes of schedule I and II controlled
received a Comment Tracking Number, directed above will be made publicly substances and assessment of annual
your comment has been successfully available in redacted form. needs for ephedrine, pseudoephedrine,
VerDate Sep<11>2014 18:49 Jul 07, 2015 Jkt 235001 PO 00000 Frm 00107 Fmt 4703 Sfmt 4703 E:\FR\FM\08JYN1.SGM 08JYN1](https://thefederalregister.org/doc/80_FR_39286/page/1.svg)
methanone (XLR11) ....................... 15 25
[1-(5-fluoropentyl)-1H-indazol-3-yl](naphthalen-1-yl)methanone (THJ–2201) ....................................... 15 no change
1-(1,3-Benzodioxol-5-yl)-2-(methylamino)butan-1-one (butylone) ......................................................... 15 25
1-(1,3-Benzodioxol-5-yl)-2-(methylamino)pentan-1-one (pentylone) ..................................................... 15 25
1-(1-Phenylcyclohexyl)pyrrolidine .......................................................................................................... 10 no change
1-(5-Fluoropentyl)-3-(1-naphthoyl)indole (AM2201) .............................................................................. 45 no change
1-(5-Fluoropentyl)-3-(2-iodobenzoyl)indole (AM694) ............................................................................. 45 no change
1-[1-(2-Thienyl)cyclohexyl]piperidine ..................................................................................................... 15 no change
1-[2-(4-Morpholinyl)ethyl]-3-(1-naphthoyl)indole (JWH–200) ................................................................ 45 no change
1-Butyl-3-(1-naphthoyl)indole (JWH–073) ............................................................................................. 45 no change
1-Cyclohexylethyl-3-(2-methoxyphenylacetyl)indole (SR–18 and RCS–8) ........................................... 45 no change
1-Hexyl-3-(1-naphthoyl)indole (JWH–019) ............................................................................................ 45 no change
1-Methyl-4-phenyl-4-propionoxypiperidine ............................................................................................. 2 no change
1-Pentyl-3-(1-naphthoyl)indole (JWH–018 and AM678) ....................................................................... 45 no change
1-Pentyl-3-(2-chlorophenylacetyl)indole (JWH–203) ............................................................................. 45 no change
1-Pentyl-3-(2-methoxyphenylacetyl)indole (JWH–250) ......................................................................... 45 no change
1-Pentyl-3-(4-chloro-1-naphthoyl)indole (JWH–398) ............................................................................. 45 no change
1-Pentyl-3-(4-methyl-1-naphthoyl)indole (JWH–122) ............................................................................ 45 no change
1-Pentyl-3-[(4-methoxy)-benzoyl]indole (SR–19, RCS–4) ..................................................................... 45 no change
1-Pentyl-3-[1-(4-methoxynaphthoyl)]indole (JWH–081) ........................................................................ 45 no change
srobinson on DSK5SPTVN1PROD with NOTICES
2-(2,5-Dimethoxy-4-n-propylphenyl)ethanamine (2C–P) ....................................................................... 30 no change
2-(2,5-Dimethoxy-4-ethylphenyl)ethanamine (2C–E) ............................................................................ 30 no change
2-(2,5-Dimethoxy-4-methylphenyl)ethanamine (2C–D) ......................................................................... 30 no change
2-(2,5-Dimethoxy-4-nitro-phenyl)ethanamine (2C–N) ........................................................................... 30 no change
2-(2,5-Dimethoxyphenyl)ethanamine (2C–H) ........................................................................................ 30 no change
2-(4-Bromo-2,5-dimethoxyphenyl)-N-(2-methoxybenzyl)ethanamine (25B–NBOMe; 2C–B–NBOMe; 15 25
25B; Cimbi-36).
2-(4-Chloro-2,5-dimethoxyphenyl)ethanamine (2C–C) .......................................................................... 30 no change
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![39158 Federal Register / Vol. 80, No. 130 / Wednesday, July 8, 2015 / Notices
Established Proposed
2015 Quotas Adjusted 2015
Basic class Quotas
(g) (g)
2-(4-Chloro-2,5-dimethoxyphenyl)-N-(2-methoxybenzyl)ethanamine (25C–NBOMe; 2C–C–NBOMe; 15 25
25C; Cimbi-82).
2-(4-Iodo-2,5-dimethoxyphenyl)ethanamine (2C–I) ............................................................................... 30 no change
2-(4-Iodo-2,5-dimethoxyphenyl)-N-(2-methoxybenzyl)ethanamine (25I–NBOMe; 2C–I–NBOMe; 25I; 15 no change
Cimbi-5).
2-(Methylamino)-1-phenylpentan-1-one (pentedrone) ........................................................................... 15 no change
2,5-Dimethoxy-4-ethylamphetamine (DOET) ........................................................................................ 25 no change
2,5-Dimethoxy-4-n-propylthiophenethylamine ....................................................................................... 25 no change
2,5-Dimethoxyamphetamine .................................................................................................................. 25 no change
2-[4-(Ethylthio)-2,5-dimethoxyphenyl]ethanamine (2C–T–2) ................................................................. 30 no change
2-[4-(Isopropylthio)-2,5-dimethoxyphenyl]ethanamine (2C–T–4) .......................................................... 30 no change
3,4,5-Trimethoxyamphetamine .............................................................................................................. 25 no change
3,4-Methylenedioxyamphetamine (MDA) .............................................................................................. 55 no change
3,4-Methylenedioxymethamphetamine (MDMA) ................................................................................... 50 no change
3,4-Methylenedioxy-N-ethylamphetamine (MDEA) ............................................................................... 40 no change
3,4-Methylenedioxy-N-methylcathinone (methylone) ............................................................................ 50 no change
3,4-Methylenedioxypyrovalerone (MDPV) ............................................................................................. 35 no change
3-Fluoro-N-methylcathinone (3–FMC) ................................................................................................... 15 25
3-Methylfentanyl ..................................................................................................................................... 2 no change
3-Methylthiofentanyl ............................................................................................................................... 2 no change
4-Bromo-2,5-dimethoxyamphetamine (DOB) ........................................................................................ 25 no change
4-Bromo-2,5-dimethoxyphenethylamine (2–CB) ................................................................................... 25 no change
4-Fluoro-N-methylcathinone (4–FMC) ................................................................................................... 15 25
4-Methoxyamphetamine ........................................................................................................................ 100 no change
4-Methyl-2,5-dimethoxyamphetamine (DOM) ........................................................................................ 25 no change
4-Methylaminorex .................................................................................................................................. 25 no change
4-Methyl-N-ethylcathinone (4–MEC) ..................................................................................................... 15 25
4-Methyl-N-methylcathinone (mephedrone) .......................................................................................... 45 no change
4-Methyl-a-pyrrolidinopropiophenone (4-MePPP) ................................................................................. 15 25
5-(1,1-Dimethylheptyl)-2-[(1R,3S)-3-hydroxycyclohexyl]-phenol ........................................................... 68 no change
5-(1,1-Dimethyloctyl)-2-[(1R,3S)-3-hydroxycyclohexyl]-phenol (cannabicyclohexanol or CP–47,497 53 no change
C8-homolog).
5-Methoxy-3,4-methylenedioxyamphetamine ........................................................................................ 25 no change
5-Methoxy-N,N-diisopropyltryptamine .................................................................................................... 25 no change
5-Methoxy-N,N-dimethyltryptamine ....................................................................................................... 25 no change
Acetyl-alpha-methylfentanyl ................................................................................................................... 2 no change
Acetyldihydrocodeine ............................................................................................................................. 2 no change
Acetylmethadol ...................................................................................................................................... 2 no change
Allylprodine ............................................................................................................................................ 2 no change
Alphacetylmethadol ................................................................................................................................ 2 no change
alpha-Ethyltryptamine ............................................................................................................................ 25 no change
Alphameprodine ..................................................................................................................................... 2 no change
Alphamethadol ....................................................................................................................................... 2 no change
alpha-Methylfentanyl .............................................................................................................................. 2 no change
alpha-Methylthiofentanyl ........................................................................................................................ 2 no change
alpha-Methyltryptamine (AMT) .............................................................................................................. 25 no change
alpha-Pyrrolidinobutiophenone (a-PBP) ................................................................................................ 15 25
alpha-Pyrrolidinopentiophenone (a-PVP) .............................................................................................. 15 25
Aminorex ................................................................................................................................................ 25 no change
Benzylmorphine ..................................................................................................................................... 2 no change
Betacetylmethadol ................................................................................................................................. 2 no change
beta-Hydroxy-3-methylfentanyl .............................................................................................................. 2 no change
beta-Hydroxyfentanyl ............................................................................................................................. 2 no change
Betameprodine ....................................................................................................................................... 2 no change
Betamethadol ......................................................................................................................................... 4 no change
Betaprodine ............................................................................................................................................ 2 no change
Bufotenine .............................................................................................................................................. 3 no change
Cathinone ............................................................................................................................................... 70 no change
Codeine methylbromide ......................................................................................................................... 5 no change
Codeine-N-oxide .................................................................................................................................... 305 no change
Desomorphine ........................................................................................................................................ 5 25
Diethyltryptamine ................................................................................................................................... 25 no change
srobinson on DSK5SPTVN1PROD with NOTICES
Difenoxin ................................................................................................................................................ 11,000 no change
Dihydromorphine .................................................................................................................................... 3,990,000 no change
Dimethyltryptamine ................................................................................................................................ 35 no change
Dipipanone ............................................................................................................................................. 5 no change
Fenethylline ............................................................................................................................................ 5 no change
gamma-Hydroxybutyric acid .................................................................................................................. 70,250,000 no change
Heroin .................................................................................................................................................... 25 50
Hydromorphinol ...................................................................................................................................... 2 no change
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![39160 Federal Register / Vol. 80, No. 130 / Wednesday, July 8, 2015 / Notices
Established Proposed
2015 Quotas Adjusted 2015
Basic class Quotas
(g) (g)
Lisdexamfetamine .................................................................................................................................. 29,750,000 no change
Meperidine ............................................................................................................................................. 6,250,000 no change
Meperidine Intermediate-A .................................................................................................................... 6 no change
Meperidine Intermediate-B .................................................................................................................... 11 32
Meperidine Intermediate-C .................................................................................................................... 6 no change
Metazocine ............................................................................................................................................. 19 no change
Methadone (for sale) ............................................................................................................................. 31,875,000 no change
Methadone Intermediate ........................................................................................................................ 34,375,000 no change
Methamphetamine ................................................................................................................................. 2,061,375 no change
[1,250,000 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 ..................................................................................................................................... 83,750,000 87,500,000
Morphine (for conversion) ...................................................................................................................... 91,250,000 no change
Morphine (for sale) ................................................................................................................................ 62,500,000 no change
Nabilone ................................................................................................................................................. 18,750 no change
Noroxymorphone (for conversion) ......................................................................................................... 17,500,000 no change
Noroxymorphone (for sale) .................................................................................................................... 1,475,000 no change
Opium (powder) ..................................................................................................................................... 112,500 no change
Opium (tincture) ..................................................................................................................................... 687,500 no change
Oripavine ................................................................................................................................................ 35,000,000 no change
Oxycodone (for conversion) .................................................................................................................. 8,350,000 no change
Oxycodone (for sale) ............................................................................................................................. 137,500,000 139,150,000
Oxymorphone (for conversion) .............................................................................................................. 29,000,000 no change
Oxymorphone (for sale) ......................................................................................................................... 7,750,000 no change
Pentobarbital .......................................................................................................................................... 35,000,000 no change
Phenazocine .......................................................................................................................................... 6 no change
Phencyclidine ......................................................................................................................................... 19 38
Phenmetrazine ....................................................................................................................................... 3 no change
Phenylacetone ....................................................................................................................................... 9,375,000 no change
Racemethorphan ................................................................................................................................... 3 no change
Remifentanil ........................................................................................................................................... 3,750 4,200
Secobarbital ........................................................................................................................................... 215,003 no change
Sufentanil ............................................................................................................................................... 6,255 no change
Tapentadol ............................................................................................................................................. 12,500,000 no change
Thebaine ................................................................................................................................................ 125,000,000 no change
List I Chemicals
Ephedrine (for conversion) .................................................................................................................... 1,000,000 no change
Ephedrine (for sale) ............................................................................................................................... 4,000,000 no change
Phenylpropanolamine (for conversion) .................................................................................................. 44,800,000 no change
Phenylpropanolamine (for sale) ............................................................................................................. 8,500,000 no change
Pseudoephedrine (for conversion) ........................................................................................................ 7,000 no change
Pseudoephedrine (for sale) ................................................................................................................... 224,500,000 no change
The Acting Administrator further received in response to this notice, the phenylpropanolamine. 21 CFR
proposes that aggregate production Acting Administrator may hold a public 1303.13(c) and 1315.13(f).
quotas for all other schedule I and II hearing on one or more issues raised. 21 Dated: July 1, 2015.
controlled substances included in 21 CFR 1303.13(c) and 1315.13(e). In the
Chuck Rosenberg,
CFR 1308.11 and 1308.12 remain at event the Acting Administrator decides
zero. In accordance with 21 CFR to hold such a hearing, the Acting Acting Administrator.
1303.13 and 21 CFR 1315.13, upon Administrator will publish a notice of [FR Doc. 2015–16699 Filed 7–7–15; 8:45 am]
consideration of the relevant factors, the the hearing in the Federal Register. BILLING CODE P
Acting Administrator may further adjust After consideration of any comments or
the 2015 aggregate production quotas objections, or after a hearing, if one is
and assessment of annual needs as held, the Acting Administrator will
needed. issue and publish in the Federal
srobinson on DSK5SPTVN1PROD with NOTICES
Comments Register a final order establishing any
adjustment of the 2015 aggregate
In accordance with 21 CFR 1303.13(c) production quota for each basic class of
and 1315.13(d), any interested person controlled substance and established
may submit written comments on or assessment of annual needs for the list
objections to these proposed I chemicals ephedrine,
determinations. Based on comments pseudoephedrine, and
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Document Created: 2018-02-23 09:12:16
Document Modified: 2018-02-23 09:12:16
| 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 | Notice with request for comments. | |
| Dates | Interested persons may file written comments on this notice in accordance with 21 CFR 1303.13(c) and 1315.13(d). Electronic comments must be submitted, and written comments must be postmarked, on or before August 7, 2015. Commenters should be aware that the electronic Federal Docket Management System will not accept comments after 11:59 p.m. Eastern Time on the last day of the comment period. | |
| 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 39156 |
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