[Federal Register Volume 76, Number 204 (Friday, October 21, 2011)]
[Notices]
[Pages 65537-65540]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-27283]



[[Page 65537]]

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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. DEA-358]


Controlled Substances: Proposed Aggregate Production Quotas for 
2012

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

ACTION: Notice with request for comment.

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SUMMARY: This notice proposes initial year 2012 aggregate production 
quotas for 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 November 21, 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-358'' on all electronic and written correspondence. 
DEA encourages that 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. Written 
comments submitted via regular or express mail should be sent to the 
Drug Enforcement Administration, Attention: DEA Federal Register 
Representative/OD, 8701 Morrissette Drive, Springfield, VA 22152.

FOR FURTHER INFORMATION CONTACT: Rhea D. Moore, Office of Diversion 
Control, Drug Enforcement Administration, 8701 Morrissette Drive, 
Springfield, VA 22152, Telephone: (202) 307-7165.

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.
    The proposed year 2012 aggregate production quotas represent those 
quantities of Schedule I and II controlled substances that may be 
produced in the United States in 2012 to provide adequate supplies of 
each substance for the estimated medical, scientific, research, and 
industrial needs of the United States, lawful export requirements, and 
the establishment and maintenance of reserve stocks. These quotas do 
not include imports of controlled substances for use in industrial 
processes.
    In determining the proposed 2012 aggregate production quotas, the 
DEA has taken into account the criteria that DEA is required to 
consider in accordance with 21 U.S.C. 826(a) and 21 CFR 1303.11. DEA 
proposes the aggregate production quotas for 2012 by considering (1) 
total net disposal of the class by all manufacturers during the current 
and two preceding years; (2) trends in the national rate of net 
disposal of the class; (3) total actual (or estimated) inventories of 
the class and of all substances manufactured from the class, and trends 
in inventory accumulation; (4) projected demand for such class as 
indicated by procurement quotas requested pursuant to 21 CFR 1303.12; 
and (5) other factors affecting the medical, scientific, research, and 
industrial needs in the United States, lawful export requirements, and 
reserve stocks, as the Administrator finds relevant. Other factors DEA 
considered include product development requirements of both bulk and 
finished dosage form manufacturers, and other pertinent information.
    The Administrator, therefore, proposes that the year 2012 aggregate 
production quotas for the following Schedule I and II controlled 
substances, expressed in grams of anhydrous acid or base, be 
established as follows:

------------------------------------------------------------------------
                                                         Proposed 2012
               Basic class--Schedule I                    quotas  (g)
------------------------------------------------------------------------
1-[2-(4-Morpholinyl)ethyl]-3-(1-naphthoyl)indole (JWH-                45
 200)................................................
1-Butyl-3-(1-naphthoyl)indole (JWH-073)..............                 45
1-Methyl-4-phenyl-4-propionoxypiperidine.............                  2
1-Pentyl-3-(1-naphthoyl)indole (JWH-018).............                 45
2,5-Dimethoxyamphetamine.............................                  2
2,5-Dimethoxy-4-ethylamphetamine (DOET)..............                  2
2,5-Dimethoxy-4-n-propylthiophenethylamine...........                  2

[[Page 65538]]

 
3-Methylfentanyl.....................................                  2
3-Methylthiofentanyl.................................                  2
3,4-Methylenedioxyamphetamine (MDA)..................                 22
3,4-Methylenedioxy-N-ethylamphetamine (MDEA).........                 15
3,4-Methylenedioxymethamphetamine (MDMA).............                 22
3,4,5-Trimethoxyamphetamine..........................                  2
4-Bromo-2,5-dimethoxyamphetamine (DOB)...............                  2
4-Bromo-2,5-dimethoxyphenethylamine (2-CB)...........                  2
4-Methoxyamphetamine.................................                 77
4-Methylaminorex.....................................                  2
4-Methyl-2,5-dimethoxyamphetamine (DOM)..............                  2
5-(1,1-Dimethylheptyl)-2-[(1R,3S)-3-                                  68
 hydroxycyclohexyl]-phenol...........................
5-(1,1-Dimethyloctyl)-2-[(1R,3S)-3-hydroxycyclohexyl]-                53
 phenol..............................................
5-Methoxy-3,4-methylenedioxyamphetamine..............                  2
5-Methoxy-N,N-diisopropyltryptamine..................                  2
Acetyl-alpha-methylfentanyl..........................                  2
Acetyldihydrocodeine.................................                  2
Acetylmethadol.......................................                  2
Allylprodine.........................................                  2
Alphacetylmethadol...................................                  2
Alpha-ethyltryptamine................................                  2
Alphameprodine.......................................                  2
Alphamethadol........................................                  2
Alpha-methylfentanyl.................................                  2
Alpha-methylthiofentanyl.............................                  2
Alpha-methyltryptamine (AMT).........................                  2
Aminorex.............................................                  2
Benzylmorphine.......................................                  2
Betacetylmethadol....................................                  2
Beta-hydroxy-3-methylfentanyl........................                  2
Beta-hydroxyfentanyl.................................                  2
Betameprodine........................................                  2
Betamethadol.........................................                  2
Betaprodine..........................................                  2
Bufotenine...........................................                  3
Cathinone............................................                  4
Codeine-N-oxide......................................                602
Diethyltryptamine....................................                  2
Difenoxin............................................                 50
Dihydromorphine......................................          3,608,000
Dimethyltryptamine...................................                  7
Gamma-hydroxybutyric acid............................         29,000,000
Heroin...............................................                 20
Hydromorphinol.......................................                  2
Hydroxypethidine.....................................                  2
Ibogaine.............................................                  5
Lysergic acid diethylamide (LSD).....................                 16
Marihuana............................................             21,000
Mescaline............................................                  5
Methaqualone.........................................                 10
Methcathinone........................................                  4
Methyldihydromorphine................................                  2
Morphine-N-oxide.....................................                605
N-Benzylpiperazine...................................                  2
N,N-Dimethylamphetamine..............................                  2
N-Ethylamphetamine...................................                  2
N-Hydroxy-3,4-methylenedioxyamphetamine..............                  2
Noracymethadol.......................................                  2
Norlevorphanol.......................................                 52
Normethadone.........................................                  2
Normorphine..........................................                 18
Para-fluorofentanyl..................................                  2
Phenomorphan.........................................                  2
Pholcodine...........................................                  2
Psilocybin...........................................                  2
Psilocyn.............................................                  2
Tetrahydrocannabinols................................            393,000
Thiofentanyl.........................................                  2
Tilidine.............................................                 10
Trimeperidine........................................                  2
------------------------------------------------------------------------


[[Page 65539]]


------------------------------------------------------------------------
                                                         Proposed 2012
               Basic class--Schedule II                   quotas  (g)
------------------------------------------------------------------------
1-Phenylcyclohexylamine..............................                  2
1-Piperdinocyclohexanecarbonitrile...................                  2
4-Anilino-N-phenethyl-4-piperidine (ANPP)............          1,800,000
Alfentanil...........................................             11,600
Alphaprodine.........................................                  2
Amobarbital..........................................             40,007
Amphetamine (for conversion).........................          8,500,000
Amphetamine (for sale)...............................         25,300,000
Cocaine..............................................            216,000
Codeine (for conversion).............................         65,000,000
Codeine (for sale)...................................         39,605,000
Dextropropoxyphene...................................                  7
Dihydrocodeine.......................................            255,000
Diphenoxylate........................................            500,000
Ecgonine.............................................             83,000
Ethylmorphine........................................                  2
Fentanyl.............................................          1,428,000
Glutethimide.........................................                  2
Hydrocodone (for sale)...............................         59,000,000
Hydromorphone........................................          3,455,000
Isomethadone.........................................                  4
Levo-alphacetylmethadol (LAAM).......................                  3
Levomethorphan.......................................                  5
Levorphanol..........................................              3,600
Lisdexamfetamine.....................................         10,400,000
Meperidine...........................................          5,200,000
Meperidine Intermediate--A...........................                  3
Meperidine Intermediate--B...........................                  7
Meperidine Intermediate--C...........................                  3
Metazocine...........................................                  5
Methadone (for sale).................................         20,000,000
Methadone Intermediate...............................         26,000,000
Methamphetamine......................................          3,130,000
------------------------------------------------------------------------
[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
Morphine (for conversion)............................         83,000,000
Morphine (for sale)..................................         39,000,000
Nabilone.............................................             10,502
Noroxymorphone (for conversion)......................          7,200,000
Noroxymorphone (for sale)............................            401,000
Opium (powder).......................................             63,000
Opium (tincture).....................................          1,000,000
Oripavine............................................          9,800,000
Oxycodone (for conversion)...........................          5,600,000
Oxycodone (for sale).................................         98,000,000
Oxymorphone (for conversion).........................         12,800,000
Oxymorphone (for sale)...............................          5,500,000
Pentobarbital........................................         31,000,000
Phenazocine..........................................                  5
Phencyclidine........................................                 24
Phenmetrazine........................................                  2
Phenylacetone........................................          8,000,000
Racemethorphan.......................................                  2
Remifentanil.........................................              2,500
Secobarbital.........................................            336,002
Sufentanil...........................................              5,000
Tapentadol...........................................            243,000
Thebaine.............................................        116,000,000
------------------------------------------------------------------------

    The Administrator further proposes that aggregate production quotas 
for all other Schedule I and II controlled substances included in 21 
CFR 1308.11 and 1308.12 be established at zero. Pursuant to 21 CFR 
1303.13, upon consideration of the relevant factors, the Administrator 
of the DEA may adjust the 2012 aggregate production quotas as needed.

Comments

    Pursuant to 21 CFR 1303.11, 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

[[Page 65540]]

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 the 2012 aggregate 
production quota for the basic class of controlled substance.

    Dated: October 7, 2011.
Michele M. Leonhart,
Administrator.
[FR Doc. 2011-27283 Filed 10-20-11; 8:45 am]
BILLING CODE 4410-09-P