[Federal Register Volume 65, Number 244 (Tuesday, December 19, 2000)]
[Notices]
[Pages 79428-79431]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-32299]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[DEA #207E]


Controlled Substances: Established Initial Aggregate Production 
Quotas for 2001

AGENCY: Drug Enforcement Administration (DEA), Justice.

ACTION: Notice of aggregate production quotas for 2001.

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SUMMARY: This notice establishes initial 2001 aggregate production 
quotas for controlled substances in Schedules I and II of the 
Controlled Substances Act (CSA).

EFFECTIVE DATE: December 19, 2000.

FOR FURTHER INFORMATION CONTACT: Frank L. Sapienza, Chief, Drug & 
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 2001 aggregate production quotas represent those quantities of 
controlled substances that may be produced in the United States in 2001 
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 October 4, 2000, a notice of the proposed initial 2001 aggregate 
production quotas for certain controlled substances in Schedules I and 
II was published in the Federal Register (65 FR 59214). All interested 
persons were invited to comment on or object to these proposed 
aggregate production quotas on or before November 3, 2000.
    Five companies commented on a total of twenty Schedules I and II 
controlled substances within the published comment period. The 
companies commented that the proposed aggregate production quotas for 
alfentanil, amphetamine, dextropropoxyphene, dihydrocodeine, 
dihydromorphine, fentanyl, gamma-hydroxybutyric acid, hydrocodone (for 
sale), hydromorphone, levorphanol, methamphetamine (for conversion), 
methylphenidate, noroxymorphone (for conversion), opium, oxycodone (for 
conversion), oxymorphone and sufentanil 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. The companies also commented that 
the proposed aggregate production quotas for codeine (for conversion), 
hydrocodone (for conversion) and morphine (for conversion) could be 
reduced.
    In addition, two comments were received after the published comment 
period had ended (dated November 6, 2000 and November 10, 2000). These 
comments requested that the aggregate production quotas for 
amphetamine, anileridine, methadone (for sale), methadone intermediate 
and methylphenidate be increased. These comments were taken into 
consideration in determining the established initial 2001 aggregate 
production quotas for these substances.
    DEA has taken into consideration the above comments along with the 
relevant 2000 manufacturing quotas, current 2000 sales and inventories, 
2001 export requirements and research and product development 
requirements. Based on this information, the DEA has adjusted the 
initial aggregate production quotas for alfentanil, dihydrocodeine, 
dihydromorphine, hydrocodone (for sale), hydrocodone (for conversion), 
levorphanol, methamphetamine (for conversion), noroxymorphone (for 
conversion), opium and sufentanil to meet the legitimate needs of the 
United States.
    Regarding amphetamine, anileridine, codeine (for conversion), 
dextropropoxyphene, fentanyl, gamma-hydroxybutyric acid, hydromorphone, 
methadone (for sale), methadone intermediate, methylphenidate, morphine 
(for conversion), oxycodone (for conversion) and oxymorphone, the DEA 
has determined that the proposed initial 2001 aggregate production 
quotas are sufficient to meet the current 2001 estimated medical, 
scientific, research

[[Page 79429]]

and industrial needs of the United States.
    Pursuant to section 1303 of title 21 of the Code of Federal 
Regulations, the Deputy Administrator of the DEA will, in early 2001, 
adjust aggregate production quotas and individual manufacturing quotas 
allocated for the year based upon 2000 year-end inventory and actual 
2000 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), 
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 orders that the 
2001 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 2001
                                                              Quotas
------------------------------------------------------------------------
                               Schedule I
------------------------------------------------------------------------
2,5-Dimethoxyamphetamine................................      15,501,000
2,5-Dimethoxy-4-ethylamphetamine (DOET).................               2
3-Methylfentanyl........................................              14
3-Methylthiofentanyl....................................               2
3,4-Methylenedioxyamphetamine (MDA).....................              25
3,4-Methylenedioxy-N-ethylamphetamine (MDEA)............              30
3,4-Methylenedioxymethamphetamine (MDMA)................              10
3,4, 5-Trimethoxyamphetamine............................               2
4-Bromo-2,5-Dimethoxyamphetamine (DOB)..................               2
4-Bromo-2,5-Dimethoxyphenethylamine (2-CB)..............               2
4-Methoxyamphetamine....................................         201,000
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.........................................               2
Diethyltryptamine.......................................               2
Difenoxin...............................................           9,000
Dihydromorphine.........................................         771,000
Dimethyltryptamine......................................               2
Gamma-hydroxybutyric acid...............................      15,000,000
Heroin..................................................               2
Hydroxypethidine........................................               2
Lysergic acid diethylamide (LSD)........................              37
Marihuana...............................................         350,000
Mescaline...............................................               7
Methaqualone............................................              19
Methcathinone...........................................              11
Morphine-N-oxide........................................               2
N,N-Dimethylamphetamine.................................               7
N-Ethyl-1-Phenylcyclohexylamine (PCE)...................               5
N-Ethylamphetamine......................................               7
N-Hydroxy-3,4-Methylenedioxyamphetamine.................               2
Noracymethadol..........................................               2
Norlevorphanol..........................................               2
Normethadone............................................               7
Normorphine.............................................               7
Para-fluorofentanyl.....................................               2
Pholcodine..............................................               2

[[Page 79430]]

 
Propiram................................................         415,000
Psilocybin..............................................               2
Psilocyn................................................               2
Tetrahydrocannabinols...................................         131,000
Thiofentanyl............................................               2
Trimeperidine...........................................               2
------------------------------------------------------------------------
                               Schedule II
------------------------------------------------------------------------
1-Phenylcyclohexylamine.................................              12
1-Piperidinocyclohexanecarbonitrile (PCC)...............              10
Alfentanil..............................................           3,500
Alphaprodine............................................               2
Amobarbital.............................................              12
Amphetamine.............................................      10,958,000
Cocaine.................................................         251,000
Codeine (for sale)......................................      43,248,000
Codeine (for conversion)................................      59,051,000
Dextropropoxyphene......................................     134,401,000
Dihydrocodeine..........................................         474,000
Diphenoxylate...........................................         401,000
Ecgonine................................................          51,000
Ethylmorphine...........................................              12
Fentanyl................................................         440,000
Glutethimide............................................               2
Hydrocodone (for sale)..................................      22,325,000
Hydrocodone (for conversion)............................      18,000,000
Hydromorphone...........................................       1,409,000
Isomethadone............................................              12
Levo-alphacetylmethadol (LAAM)..........................          41,000
Levomethorphan..........................................               2
Levorphanol.............................................          23,000
Meperidine..............................................      10,168,000
Methadone (for sale)....................................       8,347,000
Methadone (for conversion)..............................          60,000
Methadone Intermediate..................................       9,503,000
Methamphetamine.........................................       3,187,000
    850,000 grams of levo-desoxyephedrine for use in a    ..............
     non-controlled, non-prescription product; 2,286,000
     grams for methamphetamine for conversion to a
     Schedule III product; and 51,000 grams for
     methamphetamine (for sale).........................
Methylphenidate.........................................      14,957,000
Morphine (for sale).....................................      14,706,000
Morphine (for conversion)...............................     117,675,000
Nabilone................................................               2
Noroxymorphone (for sale)...............................          25,000
Noroxymorphone (for conversion).........................       4,000,000
Opium...................................................         630,000
Oxycodone (for sale)....................................      46,680,000
Oxycodone (for conversion)..............................         449,000
Oxymorphone.............................................         264,000
Pentobarbital...........................................      22,037,000
Phencyclidine...........................................              40
Phenmetrazine...........................................               2
Phenylacetone...........................................              10
Secobarbital............................................              12
Sufentanil..............................................           1,700
Thebaine................................................      65,596,000
------------------------------------------------------------------------

    The Deputy Administrator further orders 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.
    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 provisions 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

[[Page 79431]]

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 
$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 1966. 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, D.C. 20537, telephone (202) 
307-7183.

    Dated: December 11, 2000.
Julio F. Mercado,
Deputy Administrator.
[FR Doc. 00-32299 Filed 12-18-00; 8:45 am]
BILLING CODE 4410-09-M