[Federal Register Volume 76, Number 178 (Wednesday, September 14, 2011)]
[Notices]
[Pages 56810-56814]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-23498]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. DEA-343R]


Controlled Substances: 2011 Proposed Aggregate Production Quotas

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

ACTION: Notice with request for comments.

-----------------------------------------------------------------------

SUMMARY: This notice proposes to adjust the 2011 aggregate production 
quotas for several controlled substances in schedules I and II of the 
Controlled Substances Act (CSA) and separately proposes to establish 
aggregate production quotas for five synthetic cannabinoids temporarily 
controlled in Schedule I.

DATES: Electronic comments must be submitted and written comments must

[[Page 56811]]

be postmarked on or before October 14, 2011. 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-343R'' 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 http://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: Christine A. Sannerud, Ph.D., Chief, 
UN Reporting and Quota Section, Drug Enforcement Administration, 8701 
Morrissette Drive, Springfield, VA 22152, Telephone: (202) 307-7184.

SUPPLEMENTARY INFORMATION:

Posting of Public Comments

    Please note that all comments received are considered part of the 
public record and made available for public inspection online at http://www.regulations.gov and in the DEA's public docket. Such information 
includes personal identifying information (such as your name, address, 
etc.) voluntarily submitted by the commenter.
    If you want to submit personal identifying information (such as 
your name, address, etc.) as part of your comment, but do not want it 
to be posted online or made available in the public docket, you must 
include the phrase ``PERSONAL IDENTIFYING INFORMATION'' in the first 
paragraph of your comment. You must also place all the personal 
identifying information you do not want posted online or made available 
in the public docket in the first paragraph of your comment and 
identify what information you want redacted.
    If you want to submit confidential business information as part of 
your comment, but do not want it to be posted online or made available 
in the public docket, you must include the phrase ``CONFIDENTIAL 
BUSINESS INFORMATION'' in the first paragraph of your comment. You must 
also prominently identify confidential business information to be 
redacted within the comment. If a comment has so much confidential 
business information that it cannot be effectively redacted, all or 
part of that comment may not be posted online or made available in the 
public docket.
    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. On 
September 15, 2010, a notice of proposed 2011 aggregate production 
quotas for certain controlled substances in schedules I and II was 
published in the Federal Register (75 FR 56137). That notice stipulated 
that the Administrator would adjust, as needed, the quotas in 2011 as 
provided for in 21 CFR 1303.13. The 2011 established aggregate 
production quotas were subsequently published in the Federal Register 
(75 FR 79404) on December 20, 2010.
    Additionally, on March 1, 2011, the DEA Administrator published a 
Final Order which temporarily placed five synthetic cannabinoids in 
schedule I: 1-[2-(4-Morpholinyl)ethyl]-3-(1-naphthoyl)indole (JWH-200); 
1-Butyl-3-(1-naphthoyl)indole (JWH-073); 1-Pentyl-3-(1-naphthoyl)indole 
(JWH-018); 5-(1,1-Dimethylheptyl)-2-[(1R,3S)-3-hydroxycyclohexyl]-
phenol (CP-47,497); and 5-(1,1-Dimethyloctyl)-2-[(1R,3S)-3-
hydroxycyclohexyl]-phenol (cannabicyclohexanol; CP-47,497 C8 homologue) 
(76 FR 11075). That Final Order stated that quotas for the five 
substances would be ``established based on registrations granted and 
quota applications received pursuant to part 1303 of Title 21 of the 
Code of Federal Regulations.'' 76 FR 11075. Aggregate productions 
quotas for these temporarily scheduled substances have not previously 
been established.

Analysis for Proposed Revised 2011 Aggregate Production Quotas

    DEA now proposes to adjust the established 2011 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 in the United States and lawful export requirements, 
as the Administrator finds relevant.
    In determining whether to propose adjustments to the 2011 aggregate 
production quotas, DEA considered updated information obtained from 
2010 year-end inventories, 2010 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 
Administrator, therefore, proposes to adjust the 2011 aggregate 
production quotas for some schedule I and II controlled substances, 
expressed in grams of anhydrous acid or base, as follows:

[[Page 56812]]



------------------------------------------------------------------------
                                       Previously
                                       established    Proposed adjusted
       Basic class-schedule I         initial 2011       2011 quotas
                                         quotas
------------------------------------------------------------------------
1-Methyl-4-phenyl-4-                            2 g  No Change.
 propionoxypiperidine.
2,5-Dimethoxyamphetamine...........             2 g  No Change.
2,5-Dimethoxy-4-ethylamphetamine                2 g  No Change.
 (DOET).
2,5-Dimethoxy-4-n-                              2 g  No Change.
 propylthiophenethylamine.
3-Methylfentanyl...................             2 g  No Change.
3-Methylthiofentanyl...............             2 g  No Change.
3,4-Methylenedioxyamphetamine (MDA)            22 g  No Change.
3,4-Methylenedioxy-N-                          15 g  No Change.
 ethylamphetamine (MDEA).
3,4-Methylenedioxymethamphetamine              22 g  No Change.
 (MDMA).
3,4,5-Trimethoxyamphetamine........             2 g  No Change.
4-Bromo-2,5-dimethoxyamphetamine                2 g  No Change.
 (DOB).
4-Bromo-2,5-dimethoxyphenethylamine             2 g  No Change.
 (2-CB).
4-Methoxyamphetamine...............            77 g  No Change.
4-Methylaminorex...................             2 g  No Change.
4-Methyl-2,5-dimethoxyamphetamine               2 g  No Change.
 (DOM).
5-Methoxy-3,4-                                  2 g  No Change.
 methylenedioxyamphetamine.
5-Methoxy-N,N-diisopropyltryptamine             2 g  No Change.
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  No Change.
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  No Change.
Aminorex...........................             2 g  No Change.
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  No Change.
Codeine-N-oxide....................           602 g  No Change.
Diethyltryptamine..................             2 g  No Change.
Difenoxin..........................         3,000 g  50 g.
Dihydromorphine....................     3,608,000 g  No Change.
Dimethyltryptamine.................             7 g  No Change.
Gamma-hydroxybutyric acid..........     3,000,000 g  5,434,000 g.
Heroin.............................            20 g  No Change.
Hydromorphinol.....................             2 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  No Change.
Methaqualone.......................            10 g  No Change.
Methcathinone......................             4 g  No Change.
Methyldihydromorphine..............             2 g  No Change.
Morphine-N-oxide...................           605 g  No Change.
N-Benzylpiperazine.................             2 g  No Change.
N,N-Dimethylamphetamine............             2 g  No Change.
N-Ethylamphetamine.................             2 g  No Change.
N-Hydroxy-3,4-                                  2 g  No Change.
 methylenedioxyamphetamine.
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.
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.
------------------------------------------------------------------------


[[Page 56813]]


------------------------------------------------------------------------
                                       Previously
                                       established    Proposed adjusted
      Basic class--schedule II        initial 2011       2011 quotas
                                         quotas
------------------------------------------------------------------------
1-Phenylcyclohexylamine............             2 g  No Change.
1-Piperdinocyclohexanecarbonitrile.             2 g  No Change.
4-Anilino-N-phenethyl-4-piperidine      2,500,000 g  1,800,000 g.
 (ANPP).
Alfentanil.........................         8,000 g  11,600 g.
Alphaprodine.......................             2 g  No Change.
Amobarbital........................        40,007 g  No Change.
Amphetamine (for conversion).......     7,500,000 g  8,500,000 g.
Amphetamine (for sale).............    18,600,000 g  25,300,000 g.
Cocaine............................       247,000 g  216,000 g.
Codeine (for conversion)...........    65,000,000 g  No Change.
Codeine (for sale).................    39,605,000 g  No Change.
Dextropropoxyphene.................    92,000,000 g  7 g.
Dihydrocodeine.....................       800,000 g  255,000 g.
Diphenoxylate......................       827,000 g  500,000 g.
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).............    55,000,000 g  59,000,000 g.
Hydromorphone......................     3,455,000 g  No Change.
Isomethadone.......................            11 g  2 g.
Levo-alphacetylmethadol (LAAM).....             3 g  No Change.
Levomethorphan.....................             5 g  2 g.
Levorphanol........................        10,000 g  3,600 g.
Lisdexamfetamine...................     9,000,000 g  10,400,000 g.
Meperidine.........................     6,600,000 g  5,200,000 g.
Meperidine Intermediate-A..........             3 g  No Change.
Meperidine Intermediate-B..........             7 g  No Change.
Meperidine Intermediate-C..........             3 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....................    50,000,000 g  56,000,000 g.
Morphine (for conversion)..........    83,000,000 g  70,000,000 g.
Morphine (for sale)................    39,000,000 g  No Change.
Nabilone...........................        10,502 g  No Change.
Noroxymorphone (for conversion)....     9,000,000 g  7,200,000 g.
Noroxymorphone (for sale)..........       401,000 g  No Change.
Opium (powder).....................       230,000 g  63,000 g.
Opium (tincture)...................     1,500,000 g  1,000,000 g.
Oripavine..........................    15,000,000 g  8,000,000 g.
Oxycodone (for conversion).........     5,600,000 g  No Change.
Oxycodone (for sale)...............   105,500,000 g  98,000,000 g.
Oxymorphone (for conversion).......    12,800,000 g  No Change.
Oxymorphone (for sale).............     3,070,000 g  No Change.
Pentobarbital......................    28,000,000 g  31,000,000 g.
Phenazocine........................             5 g  No Change.
Phencyclidine......................            24 g  No Change.
Phenmetrazine......................             2 g  No Change.
Phenylacetone......................     8,000,000 g  No Change.
Racemethorphan.....................             2 g  No Change.
Remifentanil.......................         2,500 g  No Change.
Secobarbital.......................       260,002 g  336,002 g.
Sufentanil.........................         7,000 g  5,000 g.
Tapentadol.........................     1,000,000 g  403,000 g.
Thebaine...........................   126,000,000 g  116,000,000 g.
------------------------------------------------------------------------

    Aggregate production quotas for all other schedule I and II 
controlled substances included in 21 CFR 1308.11 and 1308.12 remain at 
zero.

Analysis for Proposed Aggregate Production Quotas for Temporarily 
Scheduled Substances

    The proposed year 2011 aggregate production quotas represent those 
quantities of controlled substances that may be produced in the United 
States in 2011 to provide adequate supplies of each substance for 
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

[[Page 56814]]

controlled substances for use in industrial processes.
    In determining the year 2011 aggregate production quotas for the 
five temporarily scheduled controlled substances listed below, the 
Administrator considered the following factors, in accordance with 21 
U.S.C. 826(a) and 21 CFR 1303.11: Total estimated net disposal of each 
substance by all manufacturers; total estimated inventories of the 
class and of all substances manufactured in the class; projected demand 
for such class as indicated by procurement quotas requested pursuant to 
21 CFR 1303.12; and other factors affecting medical, scientific, 
research, and industrial needs of the United States and lawful export 
requirements.
    DEA has received applications for registration and quota for the 
temporarily scheduled controlled substances listed below. In examining 
the information provided by the applicant(s), along with other 
information, DEA finds that there is a current need for these 
substances. The Administrator therefore proposes that the year 2011 
aggregate production quotas for the following controlled substances, 
expressed in grams of anhydrous acid or base, be established as 
follows:

------------------------------------------------------------------------
           Basic class-schedule I                Proposed 2011  quotas
------------------------------------------------------------------------
1-[2-(4-Morpholinyl)ethyl]-3-(1-              45 g
 naphthoyl)indole (JWH-200).
1-Butyl-3-(1-naphthoyl)indole (JWH-073).....  45 g
1-Pentyl-3-(1-naphthoyl)indole (JWH-018)....  45 g
5-(1,1-Dimethylheptyl)-2-[(1R,3S)-3-          68 g
 hydroxycyclohexyl]-phenol (CP-47,497).
5-(1,1-Dimethyloctyl)-2-[(1R,3S)-3-           53 g
 hydroxycyclohexyl]-phenol
 (cannabicyclohexanol; CP-47,497 C8
 homologue).
------------------------------------------------------------------------

    Pursuant to 21 CFR part 1303, the Administrator may adjust the 2011 
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 Administrator may hold a public hearing on one or more issues 
raised. In the event the Administrator decides in her sole discretion 
to hold such a hearing, the Administrator will publish a notice of any 
such hearing in the Federal Register. After consideration of any 
comments and after a hearing, if one is held, the Administrator will 
publish in the Federal Register a Final Order determining any 
adjustment of the aggregate production quota.

    Dated: September 2, 2011.
Michele M. Leonhart,
Administrator.
[FR Doc. 2011-23498 Filed 9-13-11; 8:45 am]
BILLING CODE 4410-09-P