[Federal Register Volume 66, Number 199 (Monday, October 15, 2001)]
[Notices]
[Pages 52453-52456]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-25761]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[DEA # 207F]


Controlled Substances: Final Revised Aggregate Production Quotas 
for 2001

AGENCY: Drug Enforcement Administration (DEA), Justice.

ACTION: Notice of final aggregate production quotas for 2001.

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SUMMARY: This notice establishes final 2001 aggregate production quotas 
for controlled substances in Schedules I and II of the Controlled 
Substances Act (CSA). The DEA has taken into consideration comments 
received in response to a notice of the proposed revised aggregate 
production quotas for 2001 published August 6, 2001 (66 FR 41049). No 
comments were received in response to an interim notice establishing 
revised 2001 aggregate production quotas published August 14, 2001 (66 
FR 42680). The interim notice is adopted as published.

EFFECTIVE DATE: October 15, 2001.

FOR FURTHER INFORMATION CONTACT: Frank L. Sapienza, 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 Sec. 0.100 of Title 28 of the Code of Federal 
Regulations.
    The 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 (21 U.S.C. 826(a) and 21 CFR 
1303.11). These quotas do not include imports of controlled substances.
    On August 6, 2001, a notice of the proposed revised 2001 aggregate 
production quotas for certain controlled substances in Schedules I and 
II was published in the Federal Register (66 FR 41049). All interested 
persons were invited to comment on or object to these proposed 
aggregate production quotas on or before September 5, 2001.
    Six companies and one individual commented on a total of thirteen 
Schedules I and II controlled substances within the published comment 
period. The companies commented that the proposed aggregate production 
quotas for 4-methoxyamphetamine, amphetamine, hydrocodone (for sale), 
marihuana, methamphetamine (for sale), methylphenidate, morphine (for 
sale), noroxymorphone (for conversion), oxycodone (for sale), 
pentobarbital, phenylacetone 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. The individual's comment questioned 
the increase in the aggregate production quota for secobarbital and 
raised other issues, including how to obtain additional information 
concerning this quota.
    DEA has taken into consideration the above comments along with the 
relevant 2000 year-end inventories, initial 2001 manufacturing quotas, 
2001 export requirements, actual and projected 2001 sales and use, and 
research and product development requirements. Based on this 
information, the DEA has adjusted the final 2001 aggregate production 
quotas for marihuana, methylphenidate, morphine (for sale), 
pentobarbital and phenylacetone to meet the legitimate needs of the 
United States.
    Regarding 4-methoxyamphetamine, amphetamine, hydrocodone (for 
sale),

[[Page 52454]]

methamphetamine (for sale), noroxymorphone (for conversion), oxycodone 
(for sale) and thebaine, the DEA has determined that the proposed 
revised 2001 aggregate production quotas are sufficient to meet the 
current 2001 estimated medical, scientific, research and industrial 
needs of the United States. The proposed increase in the aggregate 
production quota for secobarbital was also determined to be necessary 
to meet the legitimate needs of the United States.
    In addition, on August 14, 2001, an interim notice establishing 
revised 2001 aggregate production quotas for methadone and methadone 
intermediate was published in the Federal Register (66 FR 42680). All 
interested parties were invited to comment on or before September 14, 
2001. No comments or objections were received regarding this interim 
notice. The aggregate production quotas established in the interim 
notice are adopted without change.
    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 2001 final aggregate production quotas for the following 
controlled substances, expressed in grams of anhydrous acid or base, be 
established as follows:

------------------------------------------------------------------------
                                                            Established
                       Basic Class                          final 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).....................              30
3,4-Methylenedioxy-N-ethylamphetamine (MDEA)............              30
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....................................         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......................................               3
Gamma-hydroxybutyric acid...............................               7
Heroin..................................................               2
Hydroxypethidine........................................               2
Lysergic acid diethylamide (LSD)........................              63
Marihuana...............................................         500,000
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

[[Page 52455]]

 
Normorphine.............................................               7
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..............................................           3,500
Alphaprodine............................................               2
Amobarbital.............................................              12
Amphetamine.............................................      13,964,000
Cocaine.................................................         251,000
Codeine (for sale)......................................      43,248,000
Codeine (for conversion)................................      59,051,000
Dextropropoxyphene......................................     153,380,000
Dihydrocodeine..........................................         334,000
Diphenoxylate...........................................         401,000
Ecgonine................................................          51,000
Ethylmorphine...........................................              12
Fentanyl................................................         440,000
Glutethimide............................................               2
Hydrocodone (for sale)..................................      23,825,000
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
Metazocine..............................................               1
Methadone (for sale)....................................      12,705,000
Methadone (for conversion)..............................          60,000
Methadone Intermediate..................................      18,004,000
Methamphetamine.........................................      *3,211,000
Methylphenidate.........................................      17,618,000
Morphine (for sale).....................................      15,615,000
Morphine (for conversion)...............................     110,774,000
Nabilone................................................               2
Noroxymorphone (for sale)...............................          25,000
Noroxymorphone (for conversion).........................       4,500,000
Opium...................................................         630,000
Oxycodone (for sale)....................................      46,680,000
Oxycodone (for conversion)..............................         449,000
Oxymorphone.............................................         264,000
Pentobarbital...........................................      27,728,000
Phencyclidine...........................................              40
Phenmetrazine...........................................               2
Phenylacetone...........................................         801,000
Secobarbital............................................       1,946,000
Sufentanil..............................................           1,700
Thebaine................................................     67,446,000
------------------------------------------------------------------------
* 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 75,000 grams for
  methamphetamine (for sale).

    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 remain 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 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

[[Page 52456]]

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 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: October 4, 2001.
Asa Hutchinson,
Administrator.
[FR Doc. 01-25761 Filed 10-12-01; 8:45 am]
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