[Federal Register Volume 66, Number 240 (Thursday, December 13, 2001)]
[Notices]
[Pages 64456-64459]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-30821]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[DEA #223E]


Controlled Substances: Established Initial Aggregate Production 
Quotas for 2002

AGENCY: Drug Enforcement Administration (DEA), Justice.

ACTION: Notice of aggregate production quotas for 2002.

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SUMMARY: This notice establishes initial 2002 aggregate production 
quotas for controlled substances in Schedules I and II of the 
Controlled Substances Act (CSA).

EFFECTIVE DATE: December 13, 2001.

FOR FURTHER INFORMATION CONTACT: Frank L. Sapienza, Chief, Drug & 
Chemical Evaluation Section, Drug Enforcement Administration, 
Washington, D.C. 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 Sec. 0.100 of Title 28 of the Code of Federal 
Regulations.
    The 2002 aggregate production quotas represent those quantities of 
controlled substances that may be produced in the United States in 2002 
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 (21 U.S.C. 826(a) and 21 CFR 1303.11). 
These quotas do not include imports of controlled substances for use in 
industrial processes.
    On November 13, 2001, a notice of the proposed initial 2002 
aggregate production quotas for certain controlled substances in 
Schedules I and II was published in the Federal Register (66 FR 56860). 
All interested persons were invited to comment on or object to these 
proposed aggregate production quotas on or before December 4, 2001.
    Nine companies commented on a total of thirty-five Schedules I and 
II controlled substances within the published comment period. The 
companies commented that the proposed aggregate production quotas for 
4-methoxyamphetamine, alfentanil, amphetamine, codeine (for sale), 
codeine (for conversion), codeine-N-oxide, dextropropoxyphene, 
difenoxin, dihydrocodeine, diphenoxylate, ecgonine, fentanyl, gamma-
hydroxybutyric acid, heroin, hydrocodone (for sale), hydromorphone, 
meperidine, methadone (for sale), methadone intermediate, 
methylphenidate, morphine (for sale), morphine (for conversion), 
morphine-N-oxide, norlevorphanol, normorphine, noroxymorphone (for 
conversion), opium, oxycodone (for sale), oxycodone (for conversion), 
oxymorphone, pentobarbital, phenylacetone, secobarbital, sufentanil and 
thebaine were insufficient to provide for the estimated medical, 
scientific, research and industrial needs of the United States, for 
export requirements and for the establishment and maintenance of 
reserve stocks.
    DEA has taken into consideration the above comments along with the 
relevant 2001 manufacturing quotas, current 2001 sales and inventories, 
2002 export requirements and research and product development 
requirements. Based on this information, the DEA has adjusted the 
initial aggregate production quotas for alfentanil, codeine (for sale), 
codeine-N-oxide, dextropropoxyphene,

[[Page 64457]]

dihydrocodeine, diphenoxylate, heroin, marihuana, meperidine, methadone 
intermediate, morphine (for sale), morphine-N-oxide, norlevorphanol, 
normorphine, opium, oxycodone (for conversion), oxymorphone, 
phenylacetone, secobarbital and sufentanil to meet the legitimate needs 
of the United States.
    Regarding 4-methoxyamphetamine, amphetamine, codeine (for 
conversion), difenoxin, ecgonine, fentanyl, gamma-hydroxybutyric acid, 
hydrocodone (for sale), hydromorphone, methadone (for sale), 
methylphenidate, morphine (for conversion), noroxymorphone (for 
conversion), oxycodone (for sale), pentobarbital and thebaine, the DEA 
has determined that the proposed initial 2002 aggregate production 
quotas are sufficient to meet the current 2002 estimated medical, 
scientific, research and industrial needs of the United States.
    Pursuant to Part 1303 of Title 21 of the Code of Federal 
Regulations, the Administrator of the DEA will, in early 2002, adjust 
aggregate production quotas and individual manufacturing quotas 
allocated for the year based upon 2001 year-end inventory and actual 
2001 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 Controlled Substances Act of 1970 (21 U.S.C. 826), 
and delegated to the Administrator of the DEA by Sec. 0.100 of Title 28 
of the Code of Federal Regulations, the Administrator hereby orders 
that the 2002 initial aggregate production quotas for the following 
controlled substances, expressed in grams of anhydrous acid or base, be 
established as follows:

------------------------------------------------------------------------
                                                            Established
                       Basic class                         initial 2002
                                                              quotas
------------------------------------------------------------------------
                               Schedule I
------------------------------------------------------------------------
2,5-Dimethoxyamphetamine................................      12,501,000
2,5-Dimethoxy-4-ethylamphetamine (DOET).................               2
3-Methylfentanyl........................................               4
3-Methylthiofentanyl....................................               2
3,4-Methylenedioxyamphetamine (MDA).....................              15
3,4-Methylenedioxy-N-ethylamphetamine (MDEA)............              15
3,4-Methylenedioxymethamphetamine (MDMA)................              15
3,4,5-Trimethoxyamphetamine.............................               2
4-Bromo-2,5-Dimethoxyamphetamine (DOB)..................               2
4-Bromo-2,5-Dimethoxyphenethylamine (2-CB)..............               2
4-Methoxyamphetamine....................................               7
4-Methylaminorex........................................               2
4-Methyl-2,5-Dimethoxyamphetamine (DOM).................               2
5-Methoxy-3,4-Methylenedioxyamphetamine.................               2
Acetyl-alpha-methylfentanyl.............................               2
Acetyldihydrocodeine....................................               2
Acetylmethadol..........................................               2
Allylprodine............................................               2
Alphacetylmethadol......................................               7
Alpha-ethyltryptamine...................................               2
Alphameprodine..........................................               2
Alphamethadol...........................................               2
Alpha-methylfentanyl....................................               2
Alpha-methylthiofentanyl................................               2
Aminorex................................................               7
Benzylmorphine..........................................               2
Betacetylmethadol.......................................               2
Beta-hydroxy-3-methylfentanyl...........................               2
Beta-hydroxyfentanyl....................................               2
Betameprodine...........................................               2
Betamethadol............................................               2
Betaprodine.............................................               2
Bufotenine..............................................               2
Cathinone...............................................               9
Codeine-N-oxide.........................................              52
Diethyltryptamine.......................................               2
Difenoxin...............................................           9,000
Dihydromorphine.........................................       1,101,000
Dimethyltryptamine......................................               3
Gamma-hydroxybutyric acid...............................               7
Heroin..................................................               9
Hydroxypethidine........................................               2
Lysergic acid diethylamide (LSD)........................              46
Marihuana...............................................         840,000
Mescaline...............................................               7
Methaqualone............................................               9
Methcathinone...........................................               9
Morphine-N-oxide........................................              52
N,N-Dimethylamphetamine.................................               7
N-Ethyl-1-Phenylcyclohexylamine (PCE)...................               5
N-Ethylamphetamine......................................               7
N-Hydroxy-3,4-Methylenedioxyamphetamine.................               2

[[Page 64458]]

 
Noracymethadol..........................................               2
Norlevorphanol..........................................              52
Normethadone............................................               7
Normorphine.............................................              57
Para-fluorofentanyl.....................................               2
Pholcodine..............................................               2
Propiram................................................         415,000
Psilocybin..............................................               2
Psilocyn................................................               2
Tetrahydrocannabinols...................................         131,000
Thiofentanyl............................................               2
Trimeperidine...........................................               2
------------------------------------------------------------------------
                               Schedule II
------------------------------------------------------------------------
1-Phenylcyclohexylamine.................................              12
1-Piperidinocyclohexanecarbonitrile (PCC)...............              10
Alfentanil..............................................             902
Alphaprodine............................................               2
Amobarbital.............................................         451,000
Amphetamine.............................................      13,964,000
Carfentanil.............................................             120
Cocaine.................................................         251,000
Codeine (for sale)......................................      43,494,000
Codeine (for conversion)................................      59,051,000
Dextropropoxyphene......................................     136,696,000
Dihydrocodeine..........................................         534,000
Diphenoxylate...........................................         708,000
Ecgonine................................................          51,000
Ethylmorphine...........................................              12
Fentanyl................................................         440,000
Glutethimide............................................               2
Hydrocodone (for sale)..................................      23,825,000
Hydrocodone (for conversion)............................      13,500,000
Hydromorphone...........................................       1,409,000
Isomethadone............................................              12
Levo-alphacetylmethadol (LAAM)..........................              12
Levomethorphan..........................................               2
Levorphanol.............................................          37,000
Meperidine..............................................      10,037,000
Metazocine..............................................               1
Methadone (for sale)....................................      12,705,000
Methadone Intermediate..................................      19,081,000
Methamphetamine.........................................      2,315,000
  325,000 grams of levo-desoxyephedrine for use in a non-controlled, non-
prescription product; 1,950,000 grams for methamphetamine for conversion
to a Schedule III product; and 40,000 grams for methamphetamine (for
sale)
 
 Methylphenidate........................................      17,618,000
Morphine (for sale).....................................      17,533,000
Morphine (for conversion)...............................     110,774,000
Nabilone................................................               2
Noroxymorphone (for sale)...............................          25,000
Noroxymorphone (for conversion).........................       6,000,000
Opium...................................................         700,000
Oxycodone (for sale)....................................      40,109,000
Oxycodone (for conversion)..............................         700,000
Oxymorphone.............................................         454,000
Pentobarbital...........................................      27,728,000
Phencyclidine...........................................              21
Phenmetrazine...........................................               2
Phenylacetone...........................................      10,218,000
Secobarbital............................................           1,002
Sufentanil..............................................           2,100
Thebaine................................................      59,090,000
------------------------------------------------------------------------

    The Administrator further orders that aggregate production quotas 
for all other Schedules I and II controlled substances included in 
Secs. 1308.11 and 1308.12 of Title 21 of the Code of Federal 
Regulations be established at zero.
    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

[[Page 64459]]

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 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 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 
$100,000,000 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.
    The Drug Enforcement Administration makes every effort to write 
clearly. If you have suggestions as to how to improve the clarity of 
this regulation, call or write Frank L. Sapienza, Chief, Drug & 
Chemical Evaluation Section, Office of Diversion Control, Drug 
Enforcement Administration, Washington, DC 20537, Telephone: (202) 307-
7183.

    Dated: December 7, 2001.
Asa Hutchinson,
Administrator.
[FR Doc. 01-30821 Filed 12-12-01; 8:45 am]
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