[Federal Register Volume 77, Number 129 (Thursday, July 5, 2012)]
[Notices]
[Pages 39737-39741]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2012-16396]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. DEA-363]


Controlled Substances: Proposed Adjustment to the Aggregate 
Production Quotas for 2012

AGENCY: Drug Enforcement Administration (DEA), Department of Justice.

ACTION: Notice with request for comments.

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SUMMARY: This notice proposes to adjust the 2012 aggregate production 
quotas for several controlled substances in schedules I and II of the 
Controlled Substances Act (CSA).

DATES: Electronic comments must be submitted and written comments must 
be postmarked on or before August 6, 2012. Commenters should be aware 
that the electronic Federal Docket Management System will not accept 
comments after midnight Eastern Time on the last day of the comment 
period.

ADDRESSES: To ensure proper handling of comments, please reference 
``Docket No. DEA-363'' on all electronic and written correspondence. 
DEA encourages all comments be submitted electronically through http://www.regulations.gov using the electronic comment form provided on that 
site. An electronic copy of this document is also available at the 
http://www.regulations.gov Web site for easy reference. Paper comments 
that duplicate the electronic submission are not necessary as all 
comments submitted to www.regulations.gov will be posted for public 
review and are part of the official docket record. Should you, however, 
wish to submit written comments via regular or express mail, they 
should be sent to the Drug Enforcement Administration, Attention: DEA 
Federal Register Representative/ODL, 8701 Morrissette Drive, 
Springfield, VA 22152.

FOR FURTHER INFORMATION CONTACT: John W. Partridge, Chief, Liaison and 
Policy Section, Drug Enforcement Administration, 8701 Morrissette 
Drive, Springfield, VA 22152, Telephone: (202) 307-4654.

SUPPLEMENTARY INFORMATION: 

Posting of Public Comments

    Please note that all comments received are considered part of the 
public record and made available for public inspection online at http://www.regulations.gov and in the DEA's public docket. Such information 
includes personal identifying

[[Page 39738]]

information (such as your name, address, etc.) voluntarily submitted by 
the commenter.
    If you want to submit personal identifying information (such as 
your name, address, etc.) as part of your comment, but do not want it 
to be posted online or made available in the public docket, you must 
include the phrase ``PERSONAL IDENTIFYING INFORMATION'' in the first 
paragraph of your comment. You must also place all the personal 
identifying information you do not want posted online or made available 
in the public docket in the first paragraph of your comment and 
identify what information you want redacted.
    If you want to submit confidential business information as part of 
your comment, but do not want it to be posted online or made available 
in the public docket, you must include the phrase ``CONFIDENTIAL 
BUSINESS INFORMATION'' in the first paragraph of your comment. You must 
also prominently identify confidential business information to be 
redacted within the comment. If a comment has so much confidential 
business information that it cannot be effectively redacted, all or 
part of that comment may not be posted online or made available in the 
public docket.
    Personal identifying information and confidential business 
information identified and located as set forth above will be redacted, 
and the comment, in redacted form, will be posted online and placed in 
the DEA's public docket file. Please note that the Freedom of 
Information Act applies to all comments received. If you wish to 
inspect the agency's public docket file in person by appointment, 
please see the FOR FURTHER INFORMATION CONTACT paragraph.

Background

    Section 306 of the CSA (21 U.S.C. 826) requires that the Attorney 
General establish aggregate production quotas for each basic class of 
controlled substance listed in schedules I and II. This responsibility 
has been delegated to the Administrator of the DEA by 28 CFR 0.100. The 
Administrator, in turn, has redelegated this function to the Deputy 
Administrator, pursuant to 28 CFR 0.104. The 2012 established aggregate 
production quotas for controlled substances in schedules I and II were 
published in the Federal Register (76 FR 78044) on December 15, 2011. 
That notice stipulated that, as provided for in 21 CFR 1303.13, all 
aggregate production quotas are subject to adjustment.

Analysis for Proposed Revised 2012 Aggregate Production Quotas

    DEA now proposes to adjust the established 2012 aggregate 
production quotas for some schedule I and II controlled substances. In 
proposing the adjustment, DEA has taken into account the criteria that 
DEA is required to consider in accordance with 21 CFR 1303.13. DEA 
proposes the adjustment of the aggregate production quotas for basic 
classes of schedule I and II controlled substances by considering (1) 
Changes in demand for the class, changes in the national rate of net 
disposal for the class, and changes in the rate of net disposal by the 
registrants holding individual manufacturing quotas for the class; (2) 
whether any increased demand or changes in the national and/or 
individual rates of net disposal are temporary, short term, or long 
term; (3) whether any increased demand can be met through existing 
inventories, increased individual manufacturing quotas, or increased 
importation without increasing the aggregate production quota; (4) 
whether any decreased demand will result in excessive inventory 
accumulation by all persons registered to handle the class; and (5) 
other factors affecting the medical, scientific, research, and 
industrial needs of the United States and lawful export requirements, 
as the Administrator finds relevant.
    In determining whether to propose adjustments to the 2012 aggregate 
production quotas, DEA considered updated information obtained from 
2011 year-end inventories, 2011 disposition data submitted by quota 
applicants, estimates of the medical needs of the United States, 
product development, and other information made available to DEA after 
the initial aggregate production quotas had been established. The 
Deputy Administrator, therefore, proposes to adjust the 2012 aggregate 
production quotas for some schedule I and II controlled substances, 
expressed in grams of anhydrous acid or base, as follows:

----------------------------------------------------------------------------------------------------------------
                                                     Previously  established 2012     Proposed  adjusted 2012
                    Basic class                                 quotas                         quotas
----------------------------------------------------------------------------------------------------------------
                                                   Schedule I
----------------------------------------------------------------------------------------------------------------
1-[1-(2-Thienyl)cyclohexyl]piperidine.............  0 g..........................  5 g.
1-[2-(4-Morpholinyl)ethyl]-3-(1-naphthoyl)indole    45 g.........................  No Change.
 (JWH-200).
1-Butyl-3-(1-naphthoyl)indole (JWH-073)...........  45 g.........................  No Change.
1-Methyl-4-phenyl-4-propionoxypiperidine..........  2 g..........................  No Change.
1-Pentyl-3-(1-naphthoyl)indole (JWH-018)..........  45 g.........................  No Change.
2,5-Dimethoxyamphetamine..........................  2 g..........................  12 g.
2,5-Dimethoxy-4-ethylamphetamine (DOET)...........  2 g..........................  12 g.
2,5-Dimethoxy-4-n-propylthiophenethylamine........  2 g..........................  12 g.
3-Methylfentanyl..................................  2 g..........................  No Change.
3-Methylthiofentanyl..............................  2 g..........................  No Change.
3,4-Methylenedioxyamphetamine (MDA)...............  22 g.........................  30 g.
3,4-Methylenedioxy-N-methylcathinone (methylone)..  8 g..........................  12 g.
3,4-Methylenedioxy-N-ethylamphetamine (MDEA)......  15 g.........................  24 g.
3,4-Methylenedioxymethamphetamine (MDMA)..........  22 g.........................  30 g.
3,4-Methylenedioxypyrovalerone (MDPV).............  8 g..........................  12 g.
3,4,5-Trimethoxyamphetamine.......................  2 g..........................  12 g.
4-Bromo-2,5-dimethoxyamphetamine (DOB)............  2 g..........................  12 g.
4-Bromo-2,5-dimethoxyphenethylamine (2-CB)........  2 g..........................  12 g.
4-Methoxyamphetamine..............................  77 g.........................  88 g.
4-Methylaminorex..................................  2 g..........................  12 g.
4-Methyl-2,5-dimethoxyamphetamine (DOM)...........  2 g..........................  12 g.
4-Methyl-N-methylcathinone (mephedrone)...........  8 g..........................  12 g.
5-(1,1-Dimethylheptyl)-2-[(1R,3S)-3-                68 g.........................  No Change.
 hydroxycyclohexyl]-phenol.
5-(1,1-Dimethyloctyl)-2-[(1R,3S)-3-                 53 g.........................  No Change.
 hydroxycyclohexyl]-phenol.

[[Page 39739]]

 
5-Methoxy-3,4-methylenedioxyamphetamine...........  2 g..........................  12 g.
5-Methoxy-N,N-diisopropyltryptamine...............  2 g..........................  12 g.
Acetyl-alpha-methylfentanyl.......................  2 g..........................  No Change.
Acetyldihydrocodeine..............................  2 g..........................  No Change.
Acetylmethadol....................................  2 g..........................  No Change.
Allylprodine......................................  2 g..........................  No Change.
Alphacetylmethadol................................  2 g..........................  No Change.
Alpha-ethyltryptamine.............................  2 g..........................  12 g.
Alphameprodine....................................  2 g..........................  No Change.
Alphamethadol.....................................  2 g..........................  No Change.
Alpha-methylfentanyl..............................  2 g..........................  No Change.
Alpha-methylthiofentanyl..........................  2 g..........................  No Change.
Alpha-methyltryptamine (AMT)......................  2 g..........................  12 g.
Aminorex..........................................  2 g..........................  12 g.
Benzylmorphine....................................  2 g..........................  No Change.
Betacetylmethadol.................................  2 g..........................  No Change.
Beta-hydroxy-3-methylfentanyl.....................  2 g..........................  No Change.
Beta-hydroxyfentanyl..............................  2 g..........................  No Change.
Betameprodine.....................................  2 g..........................  No Change.
Betamethadol......................................  2 g..........................  No Change.
Betaprodine.......................................  2 g..........................  No Change.
Bufotenine........................................  3 g..........................  No Change.
Cathinone.........................................  4 g..........................  12 g.
Codeine-N-oxide...................................  602 g........................  No Change.
Diethyltryptamine.................................  2 g..........................  12 g.
Difenoxin.........................................  50 g.........................  No Change.
Dihydromorphine...................................  3,608,000 g..................  No Change.
Dimethyltryptamine................................  7 g..........................  18 g.
Gamma-hydroxybutyric acid.........................  47,000,000 g.................  No Change.
Heroin............................................  20 g.........................  No Change.
Hydromorphinol....................................  54 g.........................  No Change.
Hydroxypethidine..................................  2 g..........................  No Change.
Ibogaine..........................................  5 g..........................  No Change.
Lysergic acid diethylamide (LSD)..................  16 g.........................  No Change.
Marihuana.........................................  21,000 g.....................  No Change.
Mescaline.........................................  5 g..........................  13 g.
Methaqualone......................................  10 g.........................  No Change.
Methcathinone.....................................  4 g..........................  12 g.
Methyldihydromorphine.............................  2 g..........................  No Change.
Morphine-N-oxide..................................  655 g........................  No Change.
N-Benzylpiperazine................................  2 g..........................  12 g.
N,N-Dimethylamphetamine...........................  2 g..........................  12 g.
N-Ethylamphetamine................................  2 g..........................  12 g.
N-Hydroxy-3,4-methylenedioxyamphetamine...........  2 g..........................  12 g.
Noracymethadol....................................  2 g..........................  No Change.
Norlevorphanol....................................  52 g.........................  No Change.
Normethadone......................................  2 g..........................  No Change.
Normorphine.......................................  18 g.........................  No Change.
Para-fluorofentanyl...............................  2 g..........................  No Change.
Phenomorphan......................................  2 g..........................  No Change.
Pholcodine........................................  2 g..........................  No Change.
Properidine.......................................  2 g..........................  No Change.
Psilocybin........................................  2 g..........................  No Change.
Psilocyn..........................................  2 g..........................  No Change.
Tetrahydrocannabinols.............................  393,000 g....................  No Change.
Thiofentanyl......................................  2 g..........................  No Change.
Tilidine..........................................  10 g.........................  No Change.
Trimeperidine.....................................  2 g..........................  No Change.
----------------------------------------------------------------------------------------------------------------
                                                   Schedule II
----------------------------------------------------------------------------------------------------------------
1-Phenylcyclohexylamine...........................  2 g..........................  No Change.
1-Piperdinocyclohexanecarbonitrile................  2 g..........................  27 g.
4-Anilino-N-phenethyl-4-piperidine (ANPP).........  1,800,000 g..................  No Change.
Alfentanil........................................  15,000 g.....................  19,550 g.
Alphaprodine......................................  2 g..........................  No Change.
Amobarbital.......................................  40,007 g.....................  No Change.
Amphetamine (for conversion)......................  8,500,000 g..................
Amphetamine (for sale) *..........................  25,300,000 g.................  33,400,000 g.
----------------------------------------------------------------------------------------------------------------

[[Page 39740]]

 
* DEA has determined that the revised total quantity to provide for the estimated medical, scientific, research,
 and industrial needs of the United States, lawful export requirements, and the establishment and maintenance of
reserve stock is 29,400,000 g. DEA has further determined that an additional 4,000,000 g is necessary to provide
   for future research and development needs and unexpected emergencies that could affect market availability.
----------------------------------------------------------------------------------------------------------------
Carfentanil.......................................  0 g..........................  5 g.
Cocaine...........................................  216,000 g....................  No Change.
Codeine (for conversion)..........................  65,000,000 g.................  No Change.
Codeine (for sale)................................  39,605,000 g.................  No Change.
Dextropropoxyphene................................  7 g..........................  No Change.
Dihydrocodeine....................................  400,000 g....................  No Change.
Diphenoxylate.....................................  900,000 g....................  No Change.
Ecgonine..........................................  83,000 g.....................  No Change.
Ethylmorphine.....................................  2 g..........................  No Change.
Fentanyl..........................................  1,428,000 g..................  No Change.
Glutethimide......................................  2 g..........................  No Change.
Hydrocodone (for sale)............................  59,000,000 g.................  63,000,000 g.
Hydromorphone.....................................  3,455,000 g..................  3,628,000 g.
Isomethadone......................................  4 g..........................  No Change.
Levo-alphacetylmethadol (LAAM)....................  3 g..........................  No Change.
Levomethorphan....................................  5 g..........................  No Change.
Levorphanol.......................................  3,600 g......................  No Change.
Lisdexamfetamine..................................  12,000,000 g.................  No Change.
Meperidine........................................  5,500,000 g..................  No Change.
Meperidine Intermediate-A.........................  5 g..........................  No Change.
Meperidine Intermediate-B.........................  9 g..........................  No Change.
Meperidine Intermediate-C.........................  5 g..........................  No Change.
Metazocine........................................  5 g..........................  No Change.
Methadone (for sale)..............................  20,000,000 g.................  No Change.
Methadone Intermediate............................  26,000,000 g.................  No Change.
Methamphetamine...................................  3,130,000 g..................  No Change.
----------------------------------------------------------------------------------------------------------------
  [750,000 grams of levo-desoxyephedrine for use in a non-controlled, non-prescription product; 2,331,000 grams
 for methamphetamine mostly for conversion to a schedule III product; and 49,000 grams for methamphetamine (for
                                                     sale)]
----------------------------------------------------------------------------------------------------------------
Methylphenidate...................................  56,000,000 g.................  No Change.
Morphine (for conversion).........................  83,000,000 g.................  No Change.
Morphine (for sale)...............................  39,000,000 g.................  No Change.
Nabilone..........................................  20,502 g.....................  No Change.
Noroxymorphone (for conversion)...................  7,200,000 g..................  No Change.
Noroxymorphone (for sale).........................  401,000 g....................  1,981,000 g.
Opium (powder)....................................  63,000 g.....................  73,000 g.
Opium (tincture)..................................  1,000,000 g..................  No Change.
Oripavine.........................................  9,800,000 g..................  15,300,000 g.
Oxycodone (for conversion)........................  5,600,000 g..................  No Change.
Oxycodone (for sale)..............................  98,000,000 g.................  98,700,000 g.
Oxymorphone (for conversion)......................  12,800,000 g.................  No Change.
Oxymorphone (for sale)............................  5,500,000 g..................  No Change.
Pentobarbital.....................................  34,000,000 g.................  No Change.
Phenazocine.......................................  5 g..........................  No Change.
Phencyclidine.....................................  24 g.........................  No Change.
Phenmetrazine.....................................  2 g..........................  No Change.
Phenylacetone.....................................  16,000,000 g.................  No Change.
Racemethorphan....................................  2 g..........................  No Change.
Remifentanil......................................  2,500 g......................  No Change.
Secobarbital......................................  336,002 g....................  No Change.
Sufentanil........................................  5,000 g......................  No Change.
Tapentadol........................................  5,400,000 g..................  No Change.
Thebaine..........................................  116,000,000 g................  No Change.
----------------------------------------------------------------------------------------------------------------

    Aggregate production quotas for all other schedule I and II 
controlled substances included in 21 CFR 1308.11 and 1308.12 remain at 
zero. Pursuant to 21 CFR part 1303, the Deputy Administrator may adjust 
the 2012 aggregate production quotas and individual manufacturing 
quotas allocated for the year.

Comments

    Pursuant to 21 CFR 1303.11 and 1303.13, any interested person may 
submit written comments on or objections to these proposed 
determinations. Based on comments received in response to this Notice, 
the Deputy Administrator may hold a public hearing on one or more 
issues raised. In the event the Deputy Administrator decides in his 
sole discretion to hold such a hearing, the Deputy Administrator will 
publish a notice of any such hearing in the Federal Register. After 
consideration of any comments and after a hearing, if one is held, the 
Deputy Administrator will publish in the Federal Register a Final

[[Page 39741]]

Order determining any adjustment of the aggregate production quota.

    Dated: June 28, 2012.
Michele M. Leonhart,
Administrator.
[FR Doc. 2012-16396 Filed 7-3-12; 8:45 am]
BILLING CODE 4410-09-P