80 FR 42540 - Proposed Aggregate Production Quotas for Schedule I and II Controlled Substances and Assessment of Annual Needs for the List I Chemicals Ephedrine, Pseudoephedrine, and Phenylpropanolamine for 2016
DEPARTMENT OF JUSTICE
Drug Enforcement Administration Federal Register Volume 80, Issue 137 (July 17, 2015)
Drug Enforcement Administration
Federal Register Volume 80, Issue 137 (July 17, 2015)
| Page Range | 42540-42544 | |
| FR Document | 2015-17561 |
[Federal Register Volume 80, Number 137 (Friday, July 17, 2015)] [Notices] [Pages 42540-42544] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2015-17561] [[Page 42540]] ----------------------------------------------------------------------- DEPARTMENT OF JUSTICE Drug Enforcement Administration [Docket No. DEA-420N] Proposed Aggregate Production Quotas for Schedule I and II Controlled Substances and Assessment of Annual Needs for the List I Chemicals Ephedrine, Pseudoephedrine, and Phenylpropanolamine for 2016 AGENCY: Drug Enforcement Administration, Department of Justice. ACTION: Notice with request for comments. ----------------------------------------------------------------------- SUMMARY: The Drug Enforcement Administration proposes to establish the 2016 aggregate production quotas for controlled substances in schedules I and II of the Controlled Substances Act and assessment of annual needs for the list I chemicals ephedrine, pseudoephedrine, and phenylpropanolamine. DATES: Interested persons may file written comments on or objections to this notice in accordance with 21 CFR 1303.11(c) and 1315.11(d). Electronic comments must be submitted, and written comments must be postmarked, on or before August 17, 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. The Administrator may hold a public hearing on one or more issues raised by the comments received in response to this notice. In the event the Administrator decides in his sole discretion to hold such a hearing, the Administrator will publish a notice of any such hearing in the Federal Register. After consideration of any comments and after a hearing, if one is held, the Administrator will publish in the Federal Register a final order establishing the 2016 aggregate production quotas for schedule I and II controlled substances, and an assessment of annual needs for the list I chemicals ephedrine, pseudoephedrine, and phenylpropanolamine. ADDRESSES: To ensure proper handling of comments, please reference ``Docket No. DEA-420N'' 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; Mailing Address: 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. They will, unless reasonable cause is given, 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 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 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 confidential business information to be redacted within the comment. Comments containing personal identifying information or confidential business information identified and located as directed above will generally be made available in redacted form. If a comment contains so much personal identifying information or confidential business information that it cannot be effectively redacted, all or part of that comment may not be made publicly available. Comments posted to http://www.regulations.gov may include any personal identifying information (such as name, address, and phone number) included in the text of your electronic submission that is not identified as directed above as personal. An electronic copy of this document is available at http://www.regulations.gov for easy reference. 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 purpose 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 ensuring an adequate supply is available 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 to establish the assessment of annual needs for the list I chemicals ephedrine, pseudoephedrine, and phenylpropanolamine. The Attorney General has delegated this function to the Administrator of the DEA pursuant to 28 CFR 0.100. Analysis for Proposed 2016 Aggregate Production Quotas and Assessment of Annual Needs The proposed year 2016 aggregate production quotas and assessment of annual needs represent those quantities [[Page 42541]] of schedule I and II controlled substances, and the list I chemicals ephedrine, pseudoephedrine, and phenylpropanolamine, to be manufactured in the United States in 2016 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 proposals include estimated imports of ephedrine, pseudoephedrine, and phenylpropanolamine but do not include estimated imports of controlled substances for use in industrial processes. In determining the proposed 2016 aggregate production quotas and assessment of annual needs, the Administrator has taken into account the criteria that is required to be considered in accordance with 21 U.S.C. 826(a), 21 CFR 1303.11 (aggregate production quotas for controlled substances), and 21 CFR 1315.11 (assessment of annual needs for ephedrine, pseudoephedrine, and phenylpropanolamine). The Administrator estimates the aggregate production quotas and assessment of annual needs for 2016 by considering the following factors: (1) Total net disposal of each class or chemical by all manufacturers and chemical importers during the current and two preceding years; (2) trends in the national rate of net disposal of the class or chemical; (3) total actual (or estimated) inventories of the class or chemical and of all substances manufactured from the class or chemical, and trends in inventory accumulation; (4) projected demand for each class or chemical as indicated by procurement and chemical import quotas requested in accordance with 21 CFR 1303.12, 1315.32, and 1315.34; and (5) other factors affecting the medical, scientific, research, and industrial needs of the United States, lawful export requirements, and reserve stocks, as the Administrator finds relevant. Other factors the Administrator 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 2016 assessment of annual needs, the DEA used the calculation methodology previously described in the 2010 and 2011 assessments of annual needs (74 FR 60294, Nov. 20, 2009, and 75 FR 79407, Dec. 20, 2010, respectively). The Administrator also specifically considered that inventory allowances granted to individual manufacturers may not always result in the availability of sufficient quantities to maintain an adequate reserve stock pursuant to 21 U.S.C. 826(a), as intended. See 21 CFR 1303.24. This would be of concern 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 Administrator proposes to include in all schedule II aggregate production quotas, and certain schedule I aggregate production quotas (difenoxin, gamma-hydroxybutyric acid, and tetrahydrocannabinols), an additional 25% of the estimated medical, scientific, and research needs as part of the amount necessary to ensure the establishment and maintenance of reserve stocks. The proposed aggregate production quotas reflect these included amounts. This action will not affect the ability of manufacturers to maintain inventory allowances as specified by regulation. The Administrator 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 Administrator. The Administrator does not anticipate utilizing the reserve in the absence of these circumstances. The Administrator, therefore, proposes to establish the 2016 aggregate production quotas for the following basic classes of schedule I and II controlled substances and assessment of annual needs for the list I chemicals ephedrine, pseudoephedrine, and phenylpropanolamine, expressed in grams of anhydrous acid or base, as follows: ------------------------------------------------------------------------ Proposed 2016 Basic class 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 [[Page 42542]] 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).... 25 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................................. 150 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 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...................................... 3,000,000 Dimethyltryptamine................................... 35 Dipipanone........................................... 5 Fenethylline......................................... 5 gamma-Hydroxybutyric acid............................ 70,250,000 Heroin............................................... 50 Hydromorphinol....................................... 2 Hydroxypethidine..................................... 2 Ibogaine............................................. 5 Lysergic acid diethylamide (LSD)..................... 40 [[Page 42543]] Marihuana............................................ 200,000 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............................................. 50 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 Trimeperidine........................................ 2 ------------------------------------------------------------------------ Schedule II ------------------------------------------------------------------------ 1-Phenylcyclohexylamine.............................. 5 1-Piperidinocyclohexanecarbonitrile.................. 5 4-Anilino-N-phenethyl-4-piperidine (ANPP)............ 2,950,000 Alfentanil........................................... 17,750 Alphaprodine......................................... 3 Amobarbital.......................................... 25,125 Amphetamine (for conversion)......................... 15,000,000 Amphetamine (for sale)............................... 37,500,000 Carfentanil.......................................... 19 Cocaine.............................................. 200,000 Codeine (for conversion)............................. 50,000,000 Codeine (for sale)................................... 63,900,000 Dextropropoxyphene................................... 45 Dihydrocodeine....................................... 226,375 Diphenoxylate (for conversion)....................... 31,250 Diphenoxylate (for sale)............................. 1,337,500 Ecgonine............................................. 125,000 Ethylmorphine........................................ 3 Fentanyl............................................. 2,300,000 Glutethimide......................................... 3 Hydrocodone (for conversion)......................... 235,000 Hydrocodone (for sale)............................... 88,500,000 Hydromorphone........................................ 7,000,000 Isomethadone......................................... 5 Levo-alphacetylmethadol (LAAM)....................... 4 Levomethorphan....................................... 30 Levorphanol.......................................... 7,125 Lisdexamfetamine..................................... 29,750,000 Meperidine........................................... 5,450,000 Meperidine Intermediate-A............................ 6 Meperidine Intermediate-B............................ 11 Meperidine Intermediate-C............................ 6 Metazocine........................................... 19 [[Page 42544]] 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...................................... 87,500,000 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............................................ 30,000,000 Oxycodone (for conversion)........................... 6,250,000 Oxycodone (for sale)................................. 139,150,000 Oxymorphone (for conversion)......................... 29,000,000 Oxymorphone (for sale)............................... 7,750,000 Pentobarbital........................................ 38,125,000 Phenazocine.......................................... 6 Phencyclidine........................................ 50 Phenmetrazine........................................ 3 Phenylacetone........................................ 50 Racemethorphan....................................... 3 Remifentanil......................................... 3,750 Secobarbital......................................... 215,003 Sufentanil........................................... 6,255 Tapentadol........................................... 25,500,000 Thebaine............................................. 125,000,000 ------------------------------------------------------------------------ List I Chemicals ------------------------------------------------------------------------ Ephedrine (for conversion)........................... 100,000 Ephedrine (for sale)................................. 4,000,000 Phenylpropanolamine (for conversion)................. 22,400,000 Phenylpropanolamine (for sale)....................... 8,500,000 Pseudoephedrine (for conversion)..................... 7,000 Pseudoephedrine (for sale)........................... 224,500,000 ------------------------------------------------------------------------ The Administrator further proposes that the aggregate production quotas for all other basic classes of 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 Administrator may adjust the 2016 aggregate production quotas and assessment of annual needs as necessary. Dated: July 13, 2015. Chuck Rosenberg, Acting Administrator. [FR Doc. 2015-17561 Filed 7-16-15; 8:45 am] BILLING CODE P
![42540 Federal Register / Vol. 80, No. 137 / Friday, July 17, 2015 / Notices
DEPARTMENT OF JUSTICE Please go to http://www.regulations.gov Comments containing personal
and follow the online instructions at identifying information or confidential
Drug Enforcement Administration that site for submitting comments. Upon business information identified and
[Docket No. DEA–420N] completion of your submission you will located as directed above will generally
receive a Comment Tracking Number for be made available in redacted form. If a
Proposed Aggregate Production your comment. Please be aware that comment contains so much personal
Quotas for Schedule I and II Controlled submitted comments are not identifying information or confidential
Substances and Assessment of instantaneously available for public business information that it cannot be
Annual Needs for the List I Chemicals view on Regulations.gov. If you have effectively redacted, all or part of that
Ephedrine, Pseudoephedrine, and received a Comment Tracking Number, comment may not be made publicly
Phenylpropanolamine for 2016 your comment has been successfully available. Comments posted to http://
submitted and there is no need to www.regulations.gov may include any
AGENCY: Drug Enforcement resubmit the same comment. Paper personal identifying information (such
Administration, Department of Justice. comments that duplicate electronic as name, address, and phone number)
ACTION: Notice with request for submissions are not necessary and are included in the text of your electronic
comments. discouraged. Should you wish to mail a submission that is not identified as
paper comment in lieu of an electronic directed above as personal.
SUMMARY: The Drug Enforcement An electronic copy of this document
comment, it should be sent via regular
Administration proposes to establish the is available at http://
or express mail to: Drug Enforcement
2016 aggregate production quotas for www.regulations.gov for easy reference.
Administration, Attention: DEA Federal
controlled substances in schedules I and
Register Representative/ODL, 8701 Legal Authority
II of the Controlled Substances Act and
Morrissette Drive, Springfield, Virginia
assessment of annual needs for the list The Drug Enforcement
22152.
I chemicals ephedrine, Administration (DEA) implements and
pseudoephedrine, and FOR FURTHER INFORMATION CONTACT: John enforces titles II and III of the
phenylpropanolamine. R. Scherbenske, Office of Diversion Comprehensive Drug Abuse Prevention
Control, Drug Enforcement and Control Act of 1970, as amended. 21
DATES: Interested persons may file Administration; Mailing Address: 8701
written comments on or objections to U.S.C. 801–971. Titles II and III are
Morrissette Drive, Springfield, Virginia referred to as the ‘‘Controlled
this notice in accordance with 21 CFR 22152, Telephone: (202) 598–6812.
1303.11(c) and 1315.11(d). Electronic Substances Act’’ and the ‘‘Controlled
SUPPLEMENTARY INFORMATION: Substances Import and Export Act,’’
comments must be submitted, and
written comments must be postmarked, respectively, and are collectively
Posting of Public Comments
on or before August 17, 2015. referred to as the ‘‘Controlled
Please note that all comments Substances Act’’ or the ‘‘CSA’’ for the
Commenters should be aware that the received in response to this docket are
electronic Federal Docket Management purpose of this action. The DEA
considered part of the public record. publishes the implementing regulations
System will not accept comments after They will, unless reasonable cause is
11:59 p.m. Eastern Time on the last day for these statutes in title 21 of the Code
given, be made available for public of Federal Regulations (CFR), chapter II.
of the comment period. inspection online at http://
The Administrator may hold a public The CSA and its implementing
www.regulations.gov. Such information regulations are designed to prevent,
hearing on one or more issues raised by includes personal identifying
the comments received in response to detect, and eliminate the diversion of
information (such as your name, controlled substances and listed
this notice. In the event the address, etc.) voluntarily submitted by
Administrator decides in his sole chemicals into the illicit market while
the commenter. The Freedom of ensuring an adequate supply is available
discretion to hold such a hearing, the Information Act applies to all comments
Administrator will publish a notice of for the legitimate medical, scientific,
received. If you want to submit personal research, and industrial needs of the
any such hearing in the Federal identifying information (such as your
Register. After consideration of any United States. Controlled substances
name, address, etc.) as part of your have the potential for abuse and
comments and after a hearing, if one is comment, but do not want it to be
held, the Administrator will publish in dependence and are controlled to
posted online or made available in the protect the public health and safety.
the Federal Register a final order public docket, you must include the
establishing the 2016 aggregate Section 306 of the CSA (21 U.S.C.
phrase ‘‘PERSONAL IDENTIFYING 826) requires the Attorney General to
production quotas for schedule I and II INFORMATION’’ in the first paragraph
controlled substances, and an establish aggregate production quotas
of your comment. You must also place for each basic class of controlled
assessment of annual needs for the list all the personal identifying information
I chemicals ephedrine, substance listed in schedules I and II
you do not want publicly available in and to establish the assessment of
pseudoephedrine, and the first paragraph of your comment and
phenylpropanolamine. annual needs for the list I chemicals
identify what information you want ephedrine, pseudoephedrine, and
ADDRESSES: To ensure proper handling redacted. phenylpropanolamine. The Attorney
of comments, please reference ‘‘Docket If you want to submit confidential General has delegated this function to
No. DEA–420N’’ on all correspondence, business information as part of your the Administrator of the DEA pursuant
including any attachments. The Drug comment, but do not want it to be made
srobinson on DSK5SPTVN1PROD with NOTICES
to 28 CFR 0.100.
Enforcement Administration encourages publicly available, you must include the
that all comments be submitted phrase ‘‘CONFIDENTIAL BUSINESS Analysis for Proposed 2016 Aggregate
electronically through the Federal INFORMATION’’ in the first paragraph Production Quotas and Assessment of
eRulemaking Portal which provides the of your comment. You must also Annual Needs
ability to type short comments directly prominently identify confidential The proposed year 2016 aggregate
into the comment field on the Web page business information to be redacted production quotas and assessment of
or attach a file for lengthier comments. within the comment. annual needs represent those quantities
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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
srobinson on DSK5SPTVN1PROD with NOTICES
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
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![42542 Federal Register / Vol. 80, No. 137 / Friday, July 17, 2015 / Notices
Proposed 2016
Basic class quotas
(g)
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) ................................................................................................................... 25
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 ................................................................................................................................................................ 150
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-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
Acetyldihydrocodeine ..................................................................................................................................................................... 2
Acetylmethadol .............................................................................................................................................................................. 2
Allylprodine .................................................................................................................................................................................... 2
Alphacetylmethadol ........................................................................................................................................................................ 2
alpha-Ethyltryptamine .................................................................................................................................................................... 25
Alphameprodine ............................................................................................................................................................................. 2
Alphamethadol ............................................................................................................................................................................... 2
alpha-Methylfentanyl ...................................................................................................................................................................... 2
alpha-Methylthiofentanyl ................................................................................................................................................................ 2
alpha-Methyltryptamine (AMT) ...................................................................................................................................................... 25
alpha-Pyrrolidinobutiophenone (a-PBP) ........................................................................................................................................ 25
alpha-Pyrrolidinopentiophenone (a-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 ............................................................................................................................................................................ 3,000,000
Dimethyltryptamine ........................................................................................................................................................................ 35
srobinson on DSK5SPTVN1PROD with NOTICES
Dipipanone ..................................................................................................................................................................................... 5
Fenethylline .................................................................................................................................................................................... 5
gamma-Hydroxybutyric acid .......................................................................................................................................................... 70,250,000
Heroin ............................................................................................................................................................................................ 50
Hydromorphinol .............................................................................................................................................................................. 2
Hydroxypethidine ........................................................................................................................................................................... 2
Ibogaine ......................................................................................................................................................................................... 5
Lysergic acid diethylamide (LSD) .................................................................................................................................................. 40
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![42544 Federal Register / Vol. 80, No. 137 / Friday, July 17, 2015 / Notices
Proposed 2016
Basic class quotas
(g)
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 ............................................................................................................................................................................. 87,500,000
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 ........................................................................................................................................................................................ 30,000,000
Oxycodone (for conversion) .......................................................................................................................................................... 6,250,000
Oxycodone (for sale) ..................................................................................................................................................................... 139,150,000
Oxymorphone (for conversion) ...................................................................................................................................................... 29,000,000
Oxymorphone (for sale) ................................................................................................................................................................. 7,750,000
Pentobarbital .................................................................................................................................................................................. 38,125,000
Phenazocine .................................................................................................................................................................................. 6
Phencyclidine ................................................................................................................................................................................. 50
Phenmetrazine ............................................................................................................................................................................... 3
Phenylacetone ............................................................................................................................................................................... 50
Racemethorphan ........................................................................................................................................................................... 3
Remifentanil ................................................................................................................................................................................... 3,750
Secobarbital ................................................................................................................................................................................... 215,003
Sufentanil ....................................................................................................................................................................................... 6,255
Tapentadol ..................................................................................................................................................................................... 25,500,000
Thebaine ........................................................................................................................................................................................ 125,000,000
List I Chemicals
Ephedrine (for conversion) ............................................................................................................................................................ 100,000
Ephedrine (for sale) ....................................................................................................................................................................... 4,000,000
Phenylpropanolamine (for conversion) .......................................................................................................................................... 22,400,000
Phenylpropanolamine (for sale) ..................................................................................................................................................... 8,500,000
Pseudoephedrine (for conversion) ................................................................................................................................................ 7,000
Pseudoephedrine (for sale) ........................................................................................................................................................... 224,500,000
The Administrator further proposes DEPARTMENT OF JUSTICE objections were submitted for this
that the aggregate production quotas for notice.
all other basic classes of schedule I and Drug Enforcement Administration The DEA has considered the factors in
II controlled substances included in 21 21 U.S.C. 823, 952(a) and 958(a) and
CFR 1308.11 and 1308.12 remain at [Docket No. DEA–392] determined that the registration of Meda
zero. In accordance with 21 CFR Pharmaceuticals, Inc. to import the
Importer of Controlled Substances
1303.13 and 21 CFR 1315.13, upon basic class of controlled substance is
Registration: Meda Pharmaceuticals,
consideration of the relevant factors, the consistent with the public interest and
Inc.
Administrator may adjust the 2016 with United States obligations under
aggregate production quotas and ACTION: Notice of registration. international treaties, conventions, or
assessment of annual needs as protocols in effect on May 1, 1971. The
necessary. SUMMARY: Meda Pharmaceuticals, Inc. DEA investigated the company’s
applied to be registered as an importer maintenance of effective controls
Dated: July 13, 2015.
of a certain basic class of controlled against diversion by inspecting and
Chuck Rosenberg, substance. The Drug Enforcement testing the company’s physical security
Acting Administrator. Administration (DEA) grants Meda systems, verifying the company’s
[FR Doc. 2015–17561 Filed 7–16–15; 8:45 am] Pharmaceuticals, Inc. registration as an compliance with state and local laws,
BILLING CODE P importer of this controlled substance. and reviewing the company’s
SUPPLEMENTARY INFORMATION: By notice background and history.
srobinson on DSK5SPTVN1PROD with NOTICES
dated March 20, 2015, and published in Therefore, pursuant to 21 U.S.C.
the Federal Register on March 27, 2015, 952(a) and 958(a), and in accordance
80 FR 16426, Meda Pharmaceuticals, with 21 CFR 1301.34, the above-named
Inc., 705 Eldorado Street, Decatur, company is granted registration as an
Illinois 62523 applied to be registered as importer of nabilone (7379) a basic class
an importer of a certain basic class of of controlled substance listed in
controlled substance. No comments or schedule II.
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Document Created: 2018-02-23 09:21:18
Document Modified: 2018-02-23 09:21:18
| 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 or objections to this notice in accordance with 21 CFR 1303.11(c) and 1315.11(d). Electronic comments must be submitted, and written comments must be postmarked, on or before August 17, 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 | |
| FR Citation | 80 FR 42540 |
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