[Federal Register Volume 66, Number 151 (Monday, August 6, 2001)]
[Notices]
[Pages 41049-41051]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-19513]



[[Page 41049]]

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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[DEA # 207R]


Controlled Substances: Proposed Revised Aggregate Production 
Quotas for 2001

AGENCY: Drug Enforcement Administration (DEA), Justice.

ACTION: Notice of proposed revised 2001 aggregate production quotas.

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SUMMARY: This notice proposes revised 2001 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 September 
5, 2001.

ADDRESSES: Send comments or objections to the Acting Administrator, 
Drug Enforcement Administration, Washington, D.C. 20537, Attn.: DEA 
Federal Register Representative (CCR).

FOR FURTHER INFORMATION CONTACT: Frank L. Sapienza, Chief, Drug and 
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 Section 0.100 of Title 28 of the Code of Federal 
Regulations.
    On December 19, 2000, DEA published a notice of established initial 
2001 aggregate production quotas for certain controlled substances in 
Schedules I and II (65 FR 79428). This notice stipulated that the 
Deputy Administrator of the DEA would adjust the quotas in early 2001 
as provided for in Section 1303 of Title 21 of the Code of Federal 
Regulations.
    The proposed revised 2001 aggregate production quotas represent 
those quantities of controlled substances in Schedules I and II 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. 
These quotas do not include imports of controlled substances for use in 
industrial processes.
    The proposed revisions are based on a review of 2000 year-end 
inventories, 2000 disposition data submitted by quota applicants, 
estimates of the medical needs of the United States, 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) and delegated to the 
Administrator of the DEA by Section 0.100 of Title 28 of the Code of 
Federal Regulations, the Acting Administrator hereby proposes the 
following revised 2001 aggregate production quotas for the following 
controlled substances, expressed in grams of anhydrous acid or base:

------------------------------------------------------------------------
                                                 Prevously
                                                established    Proposed
                  Basic class                     initial      revised
                                                2001 quotas  2001 quotas
------------------------------------------------------------------------
                               Schedule I
------------------------------------------------------------------------
2,5-Dimethroxyamphetamine.....................   15,501,000   15,501,000
2,5-Dimethoxy-4-ethylamphetamine (DOET).......            2            2
3-Methylfentanyl..............................           14           14
3-Methylthiofentanyl..........................            2            2
3,4-Methylendedioxyamphetamine (MDA)..........           25           30
3,4-Methylenedioxy-N-ethylamphetamine (MDEA)..           30           30
3,4-Methylenedioxymethamphetamine (MDMA)......           10           15
3,4,5-Trimethoxyamphetamine...................            2            2
4-Bromo-2,5-Dimethoxyamphetamine (DOB)........            2            2
4-Bromo-2,5-Dimethoxyphenethylamine (2-CB)....            2            2
4-Methoxyamphetamine..........................      201,000      201,000
4-Methylaminorex..............................            2            2
4-Methyl-2,5-Dimethoxyamphetamine (DOM).......            2            2
5-Methoxy-3,4-Methylenedioxyamphetamine.......            2            2
Acetyl-alpha-methylfentanyl...................            2            2
Acetyldihydrocodeine..........................            2            2
Acethylmethadol...............................            2            2
Allylprodine..................................            2            2
Alphacetylmethadol............................            7            7
Alpha-ethyltryptamine.........................            2            2
Alphameprodine................................            2            2
Alphamethadol.................................            2            2
Alpha-methylfentanyl..........................            2            2
Alpha-methylthiofentanyl......................            2            2
Aminorex......................................            7            7
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.....................................            9            9
Codeine-N-oxide...............................            2            2
Diethyltryptamine.............................            2            2
Difenoxin.....................................        9,000        9,000

[[Page 41050]]

 
Dihydromorphine...............................      771,000      771,000
Dimethyltryptamine............................            2            3
Gamma-hydroxybutyric acid.....................   15,000,000            7
Heroin........................................            2            2
Hydroxypethidine..............................            2            2
Lysergic acid diethylamide (LSD)..............           37           63
Marihuana.....................................      350,000      350,000
Mescaline.....................................            7            7
Methaqualone..................................           19           19
Methcathinone.................................           11           11
Morphine-N-oxide..............................            2            2
N,N-Dimethylamphetamine.......................            7            7
N-Ethyl-1-Phenylcyclohexylamine (PCE).........            5            5
N-Ethylamphetamine............................            7            7
N-Hydroxy-3,4-Methylenedioxyamphetamine.......            2            2
Noracymethadol................................            2            2
Norlevorphanol................................            2            2
Normethadone..................................            7            7
Normorphine...................................            7            7
Para-fluorofenthanyl..........................            2            2
Pholcodine....................................            2            2
Propiram......................................      415,000      415,000
Psilocybin....................................            2            2
Psilocyn......................................            2            2
Tetrahydrocannabinols.........................      131,000      131,000
Thiofentanyl..................................            2            2
Trimeperidine.................................            2            2
------------------------------------------------------------------------
                               Schedule II
------------------------------------------------------------------------
1-Phenylcyclohexylamine.......................           12           12
1-Piperidinocyclonhexanecarbonitrile (PCC)....           10           10
Alfentanil....................................        3,500        3,500
Alphaprodine..................................            2            2
Amobarabital..................................           12           12
Amphetamine...................................   10,958,000   13,964,000
Cocaine.......................................      251,000      251,000
Codeine (for sale)............................   43,248,000   43,248,000
Codeine (for conversion)......................   59,051,000   59,051,000
Dextropropoxyphene............................  134,401,000  153,380,000
Dihydrocodeine................................      474,000      334,000
Diphenoxylate.................................      401,000      401,000
Ecogonine.....................................       51,000       51,000
Ethylmorphine.................................           12           12
Fentanyl......................................      440,000      440,000
Glutethimide..................................            2            2
Hydrocodone (for sale)........................   22,325,000   23,825,000
Hydrocodone (for conversion)..................   18,000,000   18,000,000
Hydromorphone.................................    1,409,000    1,409,000
Isomethadone..................................           12           12
Levo-alphacetylmethadol (LAAM)................       41,000       41,000
Levomethorphan................................            2            2
Levorphanol...................................       23,000       23,000
Meperidine....................................   10,168,000   10,168,000
Metazocine....................................            0            1
Methadone (for sale)..........................    8,347,000   12,705,000
Methadone (for conversion)....................       60,000       60,000
Methadone Intermediate........................    9,503,000   18,004,000
Methamphetamine...............................    3,187,000    3,211,000
[850,000 grams of
levo-desoxy-ephedrine for use
in a non-controlled,
non-prescription product; 2,286,000
grams for meth-amphet-amine for conversion
to a Schedule III
product; and 75,000
grams for meth-amphet-amine (for sale)]
Methylphenidate...............................   14,957,000   15,946,000
Morphine (for sale)...........................   14,706,000   15,202,000
Morphine (for conversion).....................  117,675,000  110,774,000
Nabilone......................................            2            2

[[Page 41051]]

 
Noroxymorphone (for sale).....................       25,000       25,000
Noroxymorphone (for conversion)...............    4,000,000    4,500,000
Opium.........................................      630,000      630,000
Oxycodone (for sale)..........................   46,680,000   46,680,000
Oxycodone (for conversion)....................      449,000      449,000
Oxymorphone...................................      264,000      264,000
Pentobarbital.................................   22,037,000   25,025,000
Phencyclidine.................................           40           40
Phenmetrazine.................................            2            2
Phenylacetone.................................           10           10
Secobarbital..................................           12    1,946,000
Sufentanil....................................        1,700        1,700
Thebaine......................................   65,596,000   67,446,000
------------------------------------------------------------------------

    The Acting Administrator further proposes 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 remain at zero.
    All interested persons are invited to submit their comments and 
objections in writing regarding this proposal. 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 Acting Administrator finds warrant a hearing, 
the Acting 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 Acting 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 Acting 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 DEA 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: July 31, 2001.
William B. Simpkins,
Acting Administrator.
[FR Doc. 01-19513 Filed 8-3-01; 8:45 am]
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