[Federal Register Volume 69, Number 232 (Friday, December 3, 2004)]
[Notices]
[Pages 70284-70287]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-26689]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. DEA-259P]


Controlled Substances: Proposed Aggregate Production Quotas for 
2005

AGENCY: Drug Enforcement Administration (DEA), Justice.

ACTION: Notice of proposed year 2005 aggregate production quotas.

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SUMMARY: This notice proposes initial year 2005 aggregate production 
quotas for controlled substances in Schedules I and II of the 
Controlled Substances Act (CSA).

DATES: Comments or objections must be received on or before December 
27, 2004.

ADDRESSES: To ensure proper handling of comments, please reference 
``Docket No. DEA-259P'' 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/ODL. Written comments sent via express 
mail should be sent to DEA Headquarters, Attention: DEA Federal 
Register Representative/ODL, 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 Section 0.100 of Title 28 of the Code of Federal 
Regulations. The Administrator, in turn, has redelegated this function 
to the Deputy Administrator, pursuant to Section 0.104 of Title 28 of 
the Code of Federal Regulations.
    The proposed year 2005 aggregate production quotas represent those 
quantities of controlled substances that may be produced in the United 
States in 2005 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 year 2005 aggregate production quotas, 
the Deputy Administrator considered the following factors: total actual 
2003 and estimated 2004 and 2005 net disposals of each substance by all 
manufacturers; estimates of 2004 year-end inventories of each substance 
and of any substance manufactured from it and trends in accumulation of 
such inventories;

[[Page 70285]]

product development requirements of both bulk and finished dosage form 
manufacturers; projected demand as indicated by procurement quota 
applications filed pursuant to Section 1303.12 of Title 21 of the Code 
of Federal Regulations; and other pertinent information.
    Pursuant to Section 1303 of Title 21 of the Code of Federal 
Regulations, the Deputy Administrator of the DEA will, in early 2005, 
adjust aggregate production quotas and individual manufacturing quotas 
allocated for the year based upon 2004 year-end inventory and actual 
2004 disposition data supplied by quota recipients for each basic class 
of Schedule I or II controlled substance.
    Therefore, under the authority vested in the Attorney General by 
Section 306 of the CSA of 1970 (21 U.S.C. 826), and delegated to the 
Administrator of the DEA by Section 0.100 of Title 28 of the Code of 
Federal Regulations, and redelegated to the Deputy Administrator 
pursuant to Section 0.104 of Title 28 of the Code of Federal 
Regulations, the Deputy Administrator hereby proposes that the year 
2005 aggregate production quotas for the following controlled 
substances, expressed in grams of anhydrous acid or base, be 
established as follows:

------------------------------------------------------------------------
                                                           Proposed year
                 Basic class--Schedule I                    2005 quotas
------------------------------------------------------------------------
2,5-Dimethoxyamphetamine................................     2,801,000 g
2,5-Dimethoxy-4-ethylamphetamine (DOET).................             2 g
2,5-Dimethoxy-4-(n)-propylthiophenethylamine............            10 g
3-Methylfentanyl........................................             2 g
3-Methylthiofentanyl....................................             2 g
3,4-Methylenedioxyamphetamine(MDA)......................            15 g
3,4-Methylenedioxy-N-ethylamphetamine (MDEA)............             5 g
3,4-Methylenedioxymethamphetamine (MDMA)................            15 g
3,4,5-Trimethoxyamphetamine.............................             2 g
4-Bromo-2,5-dimethoxyamphetamine (DOB)..................             2 g
4-Bromo-2,5-dimethoxyphenethylamine (2-CB)..............             2 g
4-Methoxyamphetamine....................................             2 g
4-Methylaminorex........................................             2 g
4-Methyl-2,5-dimethoxyamphetamine (DOM).................             2 g
5-Methoxy-3,4-methylenedioxyamphetamine.................             2 g
5-Methoxy-N,N-diisopropyltryptamine (5-MeO-DIPT)........            10 g
Acetyl-alpha-methylfentanyl.............................             2 g
Acetyldihydrocodeine....................................             2 g
Acetylmethadol..........................................             2 g
Allylprodine............................................             2 g
Alphacetylmethadol......................................             2 g
Alpha-ethyltryptamine...................................             2 g
Alphameprodine..........................................             2 g
Alphamethadol...........................................             3 g
Alpha-methyltryptamine (AMT)............................            10 g
Alpha-methylfentanyl....................................             2 g
Alpha-methylthiofentanyl................................             2 g
Aminorex................................................             2 g
Benzylmorphine..........................................             2 g
Betacetylmethadol.......................................             2 g
Beta-hydroxy-3-methylfentanyl...........................             2 g
Beta-hydroxyfentanyl....................................             2 g
Betameprodine...........................................             2 g
Betamethadol............................................             2 g
Betaprodine.............................................             2 g
Bufotenine..............................................             2 g
Cathinone...............................................             2 g
Codeine-N-oxide.........................................           252 g
Diethyltryptamine.......................................             2 g
Difenoxin...............................................         5,000 g
Dihydromorphine.........................................     1,551,000 g
Dimethyltryptamine......................................             3 g
Gamma-hydroxybutyric acid...............................     8,000,000 g
Heroin..................................................             2 g
Hydromorphinol..........................................             2 g
Hydroxypethidine........................................             2 g
Lysergic acid diethylamide (LSD)........................            60 g
Marihuana...............................................       840,020 g
Mescaline...............................................             2 g
Methaqualone............................................             5 g
Methcathinone...........................................             4 g
Methyldihydromorphine...................................             2 g
Morphine-N-oxide........................................           252 g
N,N-Dimethylamphetamine.................................             2 g
N-Ethylamphetamine......................................             2 g
N-Hydroxy-3,4-methylenedioxyamphetamine.................             2 g
Noracymethadol..........................................             2 g
Norlevorphanol..........................................            52 g
Normethadone............................................             2 g

[[Page 70286]]

 
Normorphine.............................................            12 g
Para-fluorofentanyl.....................................             2 g
Phenomorphan............................................             2 g
Pholcodine..............................................             2 g
Propiram................................................        50,000 g
Psilocybin..............................................             2 g
Psilocyn................................................             7 g
Tetrahydrocannabinols...................................       211,000 g
Thiofentanyl............................................             2 g
Trimeperidine...........................................             2 g
------------------------------------------------------------------------


------------------------------------------------------------------------
                                                           Proposed year
                Basic class--Schedule II                    2005 quotas
------------------------------------------------------------------------
1-Phenylcyclohexylamine.................................             2 g
Alfentanil..............................................         2,500 g
Alphaprodine............................................             2 g
Amobarbital.............................................             2 g
Amphetamine.............................................    12,700,000 g
Cocaine.................................................       228,000 g
Codeine (for sale)......................................    39,605,000 g
Codeine (for conversion)................................    55,000,000 g
Dextropropoxyphene......................................   167,365,000 g
Dihydrocodeine..........................................       748,000 g
Diphenoxylate...........................................       571,000 g
Ecgonine................................................        53,000 g
Ethylmorphine...........................................             2 g
Fentanyl................................................     1,428,000 g
Glutethimide............................................             2 g
Hydrocodone (for sale)..................................    37,604,000 g
Hydrocodone (for conversion)............................     g 1,500,000
Hydromorphone...........................................     1,951,000 g
Isomethadone............................................             2 g
Levo-alphacetylmethadol (LAAM)..........................             2 g
Levomethorphan..........................................             2 g
Levorphanol.............................................         5,000 g
Meperidine..............................................     9,753,000 g
Metazocine..............................................             1 g
Methadone (for sale)....................................    13,900,000 g
Methadone Intermediate..................................    18,000,000 g
Methamphetamine.........................................    2,782,000 g
[680,000 grams of levo-desoxyephedrine for use in a non-controlled, non-
 prescription product; 2,050,000 grams for methamphetamine mostly for
 conversion to a Schedule III product; and 52,000 grams for
 methamphetamine (for sale)]
Methylphenidate.........................................    30,817,000 g
Morphine (for sale).....................................    35,000,000 g
Morphine (for conversion)...............................   110,774,000 g
Nabilone................................................             2 g
Noroxymorphone (for sale)...............................         1,002 g
Noroxymorphone (for conversion).........................     4,000,000 g
Opium...................................................     1,180,000 g
Oxycodone (for sale)....................................    49,200,000 g
Oxycodone (for conversion)..............................       920,000 g
Oxymorphone.............................................       534,000 g
Pentobarbital...........................................    18,251,000 g
Phencyclidine...........................................         2,006 g
Phenmetrazine...........................................             2 g
Racemethorphan..........................................             2 g
Secobarbital............................................             2 g
Sufentanil..............................................         4,000 g
Thebaine................................................    72,453,000 g
------------------------------------------------------------------------

    The Deputy Administrator further proposes that aggregate production 
quotas for all other Schedules I and II controlled substances included 
in Sections 1308.11 and 1308.12 of Title 21 of the Code of Federal 
Regulations be established 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

[[Page 70287]]

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.
    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 
have no 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 
$114,000,000 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: November 30, 2004.
Michele M. Leonhart,
Deputy Administrator.
[FR Doc. 04-26689 Filed 12-2-04; 8:45 am]
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