[Federal Register Volume 69, Number 174 (Thursday, September 9, 2004)]
[Notices]
[Pages 54703-54705]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-20369]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. DEA-249R]


Controlled Substances: Proposed Revised Aggregate Production 
Quotas for 2004

AGENCY: Drug Enforcement Administration (DEA), Justice.

ACTION: Notice of proposed revised 2004 aggregate production quotas.

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SUMMARY: This notice proposes revised 2004 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 September 30, 2004.

ADDRESSES: To ensure proper handling of comments, please reference 
``Docket No. DEA-249'' 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 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 Sec.  0.104 of Title 28 of the 
Code of Federal Regulations.
    On December 15, 2003, DEA published a notice of established initial 
2004 aggregate production quotas for certain controlled substances in 
Schedules I and II (68 FR 69720). This notice stipulated that the DEA 
would adjust the quotas in early 2004 as provided for in Part 1303 of 
Title 21 of the Code of Federal Regulations.
    The proposed revised 2004 aggregate production quotas represent 
those quantities of controlled substances in Schedules I and II that 
may be produced in the United States in 2004 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 2003 year-end 
inventories, 2003 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 Sec.  0.100 of Title 28 of the Code of 
Federal Regulations, and redelegated to the Deputy Administrator 
pursuant to Sec.  0.104 of Title 28 of the Code of Federal Regulations, 
the Deputy Administrator hereby proposes the following revised 2004 
aggregate production quotas for the following controlled substances, 
expressed in grams of anhydrous acid or base:

------------------------------------------------------------------------
                                        Previously
                                       established      Proposed revised
            Basic class                initial 2004       2004 quotas
                                          quotas
------------------------------------------------------------------------
                               Schedule I
------------------------------------------------------------------------
2,5-Dimethoxyamphetamine..........          3,501,000          3,501,000
2,5-Dimethoxy-4-ethylamphetamine                    2                  2
 (DOET)...........................
2,5-Dimethoxy-4-n-                                 10                 10
 propylthiophenethylamine (2C-T-7)
3-Methylfentanyl..................                  2                  2
3-Methylthiofentanyl..............                  2                  2
3,4-Methylenedioxyamphetamine                      11                 11
 (MDA)............................
3,4-Methylenedioxy-N-                               5                  5
 ethylamphetamine (MDEA)..........
3,4-Methylenedioxymethamphetamine                  16                 16
 (MDMA)...........................
3,4,5-Trimethoxyamphetamine.......                  2                  2
4-Bromo-2,5-Dimethoxyamphetamine                    2                  2
 (DOB)............................
4-Bromo-2,5-                                        2                  2
 Dimethoxyphenethylamine (2-CB)...
4-Methoxyamphetamine..............                  2                  2
4-Methylaminorex..................                  2                  2
4-Methyl-2,5-Dimethoxyamphetamine                   2                  2
 (DOM)............................
5-Methyoxy-3,4-                                     2                  2
 Methylenedioxyamphetamine........
5-Methoxy-N,N-                                     10                 10
 diisopropyltryptamine (5-MeO-
 DIPT)............................
Acetyl-alpha-methylfentanyl.......                  2                  2
Acetyldihydrocodeine..............                  2                  2
Acetylmethadol....................                  2                  2
Allylprodine......................                  4                  4

[[Page 54704]]

 
Alphacetylmethadol................                  2                  2
Alpha-ethyltryptamine.............                  2                  2
Alphameprodine....................                  2                  2
Alphamethadol.....................                  3                  3
Alpha-methyltryptamine (AMT)......                 10                 10
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........................                  2                  2
Cathinone.........................                  2                  2
Codeine-N-oxide...................                502                502
Diethyltryptamine.................                  2                  2
Difenoxin.........................              9,000              8,000
Dihydromorphine...................          1,101,000          1,101,000
Dimethyltryptamine................                  3                  3
Gamma-hydroxybutyric acid.........         10,000,000          8,000,000
Heroin............................                  5                  5
Hydromorphinol....................                  2                  2
Hydroxypethidine..................                  2                  2
Lysergic acid diethylamide (LSD)..                 61                 61
Marihuana.........................            840,000            840,020
Mescaline.........................                  2                  2
Methaqualone......................                  5                  5
Methcathinone.....................                  4                  4
Methyldihydromorphine.............                  2                  2
Morphine-N-oxide..................                502                502
N,N-Dimethylamphetamine...........                  2                  2
N-Ethyl-1-Phenylcyclohexylamine                     5                  5
 (PCE)............................
N-Ethylamphetamine................                  7                  7
N-Hydroxy-3,4-                                      2                  2
 Methylenedioxyamphetamine........
Noracymethadol....................                  2                  2
Norlevorphanol....................                 52                 52
Normethadone......................                  2                  2
Normorphine.......................                 12                 12
Para-fluorofentanyl...............                  2                  2
Phenomorphan......................                  2                  2
Pholcodine........................                  2                  2
Propiram..........................            210,000            210,000
Psilocybin........................                  2                  2
Psilocyn..........................                  2                  2
Tetrahydrocannabinols.............            176,000            176,000
Thiofentanyl......................                  2                  2
Trimeperidine.....................                  2                  2
-----------------------------------
                               Schedule II
------------------------------------------------------------------------
1-Phenylcyclohexylamine...........                  2                  2
1-                                                 10                 10
 Piperidinocyclohexanecarbonitrile
 (PCC)............................
Alfentanil........................              2,000              2,000
Alphaprodine......................                  2                  2
Amobarbital.......................                  3                  3
Amphetamine.......................         10,987,000         12,700,000
Cocaine...........................            186,000            200,000
Codeine (for sale)................         41,341,000         41,341,000
Codeine (for conversion)..........         43,559,000         48,000,000
Dextropropoxyphene................        167,365,000        167,365,000
Dihydrocodeine....................            776,000            776,000
Diphenoxylate.....................            716,000            836,000
Ecgonine..........................             38,000             38,000
Ethylmorphine.....................                  2                  2
Fentanyl..........................            970,000          1,225,000
Glutethimide......................                  2                  2
Hydrocodone (for sale)............         30,622,000         34,000,000
Hydrocodone (for conversion)......          1,500,000          1,500,000
Hydromorphone.....................          1,651,000          1,651,000

[[Page 54705]]

 
Isomethadone......................                  2                  2
Levo-alphacetylmethadol (LAAM)....                  2                  2
Levomethorphan....................                  2                  2
Levorphanol.......................             15,000             15,000
Meperidine........................          9,753,000          9,753,000
Metazocine........................                  1                  1
Methadone (for sale)..............         14,057,000         14,720,000
Methadone Intermediate............         18,296,000         18,296,000
Methamphetamine...................          2,275,000         2,180,000
  [675,000 grams of levo-desoxyephedrine for use in a non-controlled,
   non-prescription product; 1,475,000 grams for methamphetamine mostly
   for conversion to a Schedule III product; and 30,000 grams for
   methamphetamine (for sale)]
Methylphenidate...................         23,726,000         27,428,000
Morphine (for sale)...............         21,800,000         25,000,000
Morphine (for conversion).........        110,774,000        110,774,000
Nabilone..........................                  2                  2
Noroxymorphone (for sale).........             99,000             99,000
Noroxymorphone (for conversion)...          3,800,000          3,800,000
Opium.............................          1,000,000          1,300,000
Oxycodone (for sale)..............         41,606,000         49,200,000
Oxycodone (for conversion)........            920,000            920,000
Oxymorphone.......................            534,000            534,000
Pentobarbital.....................         18,251,000         18,251,000
Phencyclidine.....................              2,060              2,060
Phenmetrazine.....................                  2                  2
Phenylacetone.....................         11,000,000         11,000,000
Racemethorphan....................                  2                  2
Secobarbital......................              1,000                  2
Sufentanil........................              4,000              4,000
Thebaine..........................         59,437,000         72,400,000
------------------------------------------------------------------------

    The Deputy Administrator further proposes that aggregate production 
quotas for all other Schedules I and II controlled substances included 
in Sec.  1308.11 and 1308.12 of Title 21 of the Code of Federal 
Regulations 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) and 1303.32.
    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 
$113,000,000 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: September 1, 2004.
Michele M. Leonhart,
Deputy Administrator.
[FR Doc. 04-20369 Filed 9-8-04; 8:45 am]
BILLING CODE 4410-09-P