[Federal Register Volume 71, Number 128 (Wednesday, July 5, 2006)]
[Notices]
[Pages 38174-38176]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E6-10467]


=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. DEA-270R]


Controlled Substances: Proposed Revised Aggregate Production 
Quotas for 2006

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

ACTION: Notice of proposed revised 2006 aggregate production quotas.

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

SUMMARY: This notice proposes revised 2006 aggregate production quotas 
for controlled substances in Schedules I and II of the Controlled 
Substances Act (CSA).

DATES: Written comments must be postmarked, and electronic comments 
must be sent, on or before July 26, 2006.

ADDRESSES: To ensure proper handling of comments, please reference 
``Docket No. DEA-270R on all written and electronic correspondence. 
Written comments being sent via regular mail should be sent to the 
Deputy Assistant Administrator, Office of Diversion Control, Drug 
Enforcement Administration, Washington, DC 20537, Attention: DEA 
Federal Register Representative/CCD. Written comments sent via express 
mail should be sent to DEA Headquarters, Attention: DEA Federal 
Register Representative/CCD, 2401 Jefferson-Davis Highway, Alexandria, 
VA 22301. Comments may be directly sent to DEA electronically by 
sending an electronic message to [email protected]. 
Comments may also be sent 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. DEA will accept attachments to 
electronic comments in Microsoft Word, WordPerfect, Adobe PDF, or Excel 
file formats only. DEA will not accept any file format other than those 
specifically listed here.

FOR FURTHER INFORMATION CONTACT: Christine A. Sannerud, Ph.D., Chief, 
Drug and Chemical Evaluation Section, Drug Enforcement Administration, 
Washington, DC 20537, Telephone: (202) 307-7183.

SUPPLEMENTARY INFORMATION: 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.
    On December 9, 2005, DEA published a notice of established initial 
2006 aggregate production quotas for certain controlled substances in 
Schedules I and II (70 FR 73269). This notice stipulated that the DEA 
would adjust the quotas in early 2006 as provided for in 21 CFR part 
1303.
    The proposed revised 2006 aggregate production quotas represent 
those quantities of controlled substances in Schedules I and II that 
may be produced in the United States in 2006 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.
    The proposed revisions are based on a review of 2005 year-end 
inventories, 2005 disposition data submitted by quota applicants, 
estimates of the medical needs of the United States, product 
development, and other information available to the DEA.
    Therefore, under the authority vested in the Attorney General by 
section 306 of the CSA of 1970 (21 U.S.C. 826), delegated to the 
Administrator of the DEA by 28 CFR 0.100, and redelegated to the Deputy 
Administrator pursuant to 28 CFR 0.104, the Deputy Administrator hereby 
proposes the following revised 2006 aggregate production quotas for the 
following controlled substances, expressed in grams of anhydrous acid 
or base:

------------------------------------------------------------------------
                                            Previously
                                            established      Proposed
                                           initial 2006    revised 2006
                                          quotas (grams)  quotas (grams)
------------------------------------------------------------------------
 Basic Class--Schedule I:
    2,5-Dimethoxyamphetamine............       2,801,000       2,801,000
    2,5-Dimethoxy-4-ethylamphetamine                   2               2
     (DOET).............................
    3-Methylfentanyl....................               2               2
    3-Methylthiofentanyl................               2               2
    3,4-Methylenedioxyamphetamine (MDA).              20              20
    3,4-Methylenedioxy-N-                             10              10
     ethylamphetamine (MDEA)............
    3,4-Methylenedioxymethamphetamine                 22              22
     (MDMA).............................
    3,4,5-Trimethoxyamphetamine.........               2               2
    4-Bromo-2,5-dimethoxyamphetamine                   2               2
     (DOB)..............................
    4-Bromo-2,5-dimethoxyphenethylamine                2               2
     (2-CB).............................
    4-Methoxyamphetamine................              77              77
    4-Methylaminorex....................               2               2

[[Page 38175]]

 
    4-Methyl-2,5-dimethoxyamphetamine                 12              12
     (DOM)..............................
    5-Methoxy-3,4-                                     2               2
     methylenedioxyamphetamine..........
    Acetyl-alpha-methylfentanyl.........               2               2
    Acetyldihydrocodeine................               2               2
    Acetylmethadol......................               2               2
    Allylprodine........................               2               2
    Alphacetylmethadol..................               2               2
    Alpha-ethyltryptamine...............               2               2
    Alphameprodine......................               2               2
    Alphamethadol.......................               3               3
    Alpha-methylfentanyl................               2               2
    Alpha-methylthiofentanyl............               2               2
    Aminorex............................               2               2
    Benzylmorphine......................               2               2
    Betacetylmethadol...................               2               2
    Beta-hydroxy-3-methylfentanyl.......               2               2
    Beta-hydroxyfentanyl................               2               2
    Betameprodine.......................               2               2
    Betamethadol........................               2               2
    Betaprodine.........................               2               2
    Bufotenine..........................               5               5
    Cathinone...........................               3               3
    Codeine-N-oxide.....................             302             302
    Diethyltryptamine...................               2               2
    Difenoxin...........................           5,000           5,000
    Dihydromorphine.....................       1,826,000       1,826,000
    Dimethyltryptamine..................               3               3
    Gamma-hydroxybutyric acid...........       8,000,000       8,000,000
    Heroin..............................               5               5
    Hydromorphinol......................               2               2
    Hydroxypethidine....................               2               2
    Lysergic acid diethylamide (LSD)....              61              61
    Marihuana...........................       4,500,000       4,500,000
    Mescaline...........................               2               2
    Methaqualone........................              10              10
    Methcathinone.......................               4               4
    Methyldihydromorphine...............               2               2
    Morphine-N-oxide....................             310             310
    N,N-Dimethylamphetamine.............               2               2
    N-Ethylamphetamine..................               2               2
    N-Hydroxy-3,4-                                     2               2
     methylenedioxyamphetamine..........
    Noracymethadol......................               2               2
    Norlevorphanol......................              52              52
    Normethadone........................               2               2
    Normorphine.........................              16              16
    Para-fluorofentanyl.................               2               2
    Phenomorphan........................               2               2
    Pholcodine..........................               2               2
    Psilocybin..........................               7               7
    Psilocyn............................               7               7
    Tetrahydrocannabinols...............         312,500         312,500
    Thiofentanyl........................               2               2
    Trimeperidine.......................               2               2
 Basic Class--Schedule II:
    1-Phenylcyclohexylamine.............               2               2
    Alfentanil..........................           5,000           5,000
    Alphaprodine........................               2               2
    Amobarbital.........................         101,000         101,000
    Amphetamine.........................      17,000,000      17,000,000
    Cocaine.............................         286,000         286,000
    Codeine (for sale)..................      39,605,000      39,605,000
    Codeine (for conversion)............      55,000,000      55,000,000
    Dextropropoxyphene..................     167,365,000     167,365,000
    Dihydrocodeine......................       1,261,000       1,261,000
    Diphenoxylate.......................         828,000         828,000
    Ecgonine............................          83,000          83,000
    Ethylmorphine.......................               2               2
    Fentanyl............................       1,428,000       1,428,000
    Glutethimide........................               2               2
    Hydrocodone (for sale)..............      41,252,000      41,252,000
    Hydrocodone (for conversion)........       1,500,000       1,500,000

[[Page 38176]]

 
    Hydromorphone.......................       3,300,000       3,300,000
    Isomethadone........................               2               2
    Levo-alphacetylmethadol (LAAM)......               6               6
    Levomethorphan......................               5               5
    Levorphanol.........................           5,000           5,000
    Meperidine..........................       9,753,000       9,753,000
    Metazocine..........................               1               1
    Methadone (for sale)................      21,000,000      25,000,000
    Methadone Intermediate..............      26,000,000      26,000,000
    Methamphetamine.....................       3,130,000       3,130,000
    [680,000 grams of levo-
     desoxyephedrine for use in a non-
     controlled, non-prescription
     product; 2,405,000 grams for
     methamphetamine mostly for
     conversion to a Schedule III
     product; and 45,000 grams for
     methamphetamine (for sale)]
    Methylphenidate.....................      35,000,000      35,000,000
    Morphine (for sale).................      35,000,000      35,000,000
    Morphine (for conversion)...........     110,774,000     110,774,000
    Nabilone............................               2               2
    Noroxymorphone (for sale)...........           1,002           1,002
    Noroxymorphone (for conversion).....       5,600,000       5,600,000
    Opium...............................       1,280,000       1,280,000
    Oxycodone (for sale)................      49,200,000      49,200,000
    Oxycodone (for conversion)..........         920,000         920,000
    Oxymorphone.........................         534,000         534,000
    Pentobarbital.......................      20,335,000      28,000,000
    Phencyclidine.......................           2,021           2,021
    Phenmetrazine.......................               2               2
    Racemethorphan......................               2               2
    Remifentanil........................           2,700           2,700
    Secobarbital........................               2               2
    Sufentanil..........................           6,500           6,500
    Thebaine............................      72,453,000      72,453,000
------------------------------------------------------------------------

    The Deputy Administrator further proposes that aggregate production 
quotas for all other Schedules I and II controlled substances included 
in 21 CFR 1308.11 and 1308.12 remain at zero.
    All interested persons are invited to submit their comments in 
writing or electronically regarding this proposal following the 
procedures in the ADDRESSES section of this document. A person may 
object to or comment on the proposal relating to any of the above-
mentioned substances without filing comments or objections regarding 
the others. If a person believes that one or more of these issues 
warrant a hearing, the individual should so state and summarize the 
reasons for this belief.
    In the event that comments or objections to this proposal raise one 
or more issues which the Deputy Administrator finds warrant a hearing, 
the Deputy Administrator shall order a public hearing by notice in the 
Federal Register, summarizing the issues to be heard and setting the 
time for the hearing as per 21 CFR 1303.13(c).
    The Office of Management and Budget has determined that notices of 
aggregate production quotas are not subject to centralized review under 
Executive Order 12866.
    This action does not preempt or modify any provision of state law; 
nor does it impose enforcement responsibilities on any state; nor does 
it diminish the power of any state to enforce its own laws. 
Accordingly, this action does not have federalism implications 
warranting the application of Executive Order 13132.
    The Deputy Administrator hereby certifies that this action will not 
have a significant impact upon small entities whose interests must be 
considered under the Regulatory Flexibility Act, 5 U.S.C. 601 et seq. 
The establishment of aggregate production quotas for Schedules I and II 
controlled substances is mandated by law and by international treaty 
obligations. The quotas are necessary to provide for the estimated 
medical, scientific, research and industrial needs of the United 
States, for export requirements and the establishment and maintenance 
of reserve stocks. While aggregate production quotas are of primary 
importance to large manufacturers, their impact upon small entities is 
neither negative nor beneficial. Accordingly, the Deputy Administrator 
has determined that this action does not require a regulatory 
flexibility analysis.
    This action meets the applicable standards set forth in Sections 
3(a) and 3(b)(2) of Executive Order 12988 Civil Justice Reform.
    This action will not result in the expenditure by state, local, and 
tribal governments, in the aggregate, or by the private sector, of 
$118,000,000 or more in any one year, and will not significantly or 
uniquely affect small governments. Therefore, no actions were deemed 
necessary under the provisions of the Unfunded Mandates Reform Act of 
1995.
    This action is not a major rule as defined by section 804 of the 
Small Business Regulatory Enforcement Fairness Act of 1996. This action 
will not result in an annual effect on the economy of $100,000,000 or 
more; a major increase in costs or prices; or significant adverse 
effects on competition, employment, investment, productivity, 
innovation, or on the ability of United States-based companies to 
compete with foreign-based companies in domestic and export markets.

    Dated: June 26, 2006.
Michele M. Leonhart,
Deputy Administrator.
 [FR Doc. E6-10467 Filed 7-3-06; 8:45 am]
BILLING CODE 4410-09-P