[Federal Register: November 16, 2004 (Volume 69, Number 220)]
[Notices]
[Page 67172-67175]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr16no04-83]
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA-249F]
Controlled Substances: Final Revised Aggregate Production Quotas
for 2004
AGENCY: Drug Enforcement Administration (DEA), Justice.
ACTION: Notice of final aggregate production quotas for 2004.
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SUMMARY: This notice establishes final 2004 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 2004 published September 9, 2004 (69 FR 54703).
EFFECTIVE DATE: November 16, 2004.
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 Section 0.104 of Title 28 of
the Code of Federal Regulations.
The 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 (21 U.S.C. 826(a) and 21 CFR
1303.11). These quotas do not include imports of controlled substances.
On September 9, 2004 a notice of the proposed revised 2004
aggregate production quotas for certain controlled substances in
Schedules I and II was published in the Federal Register (69 FR 54703).
All interested persons were invited to comment on or object to these
proposed aggregate production quotas on or before September 30, 2004.
Eight companies commented on a total of 15 Schedules I and II
controlled substances within the published comment period. The
companies commented that the proposed aggregate production quotas for
amphetamine, codeine (for conversion), fentanyl, hydrocodone,
hydromorphone, marihuana, methamphetamine (for conversion),
methamphetamine (for sale), methylphenidate, morphine (for conversion),
morphine (for sale), opium, tetrahydrocannabinols, 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 2003 year-end inventories, initial 2004 manufacturing quotas,
2004 export requirements, actual and projected 2004 sales and use, and
research and product development requirements. Based on this
information, the DEA has adjusted the final 2004 aggregate production
quotas for codeine (for conversion), fentanyl, hydromorphone,
methamphetamine (for conversion), methamphetamine (for sale),
methylphenidate, morphine (for sale), tetrahydrocannabinols, and
thebaine to meet the legitimate needs of the United States.
Regarding amphetamine, hydrocodone, marihuana, morphine (for
conversion), and opium the DEA has determined that the proposed revised
2004 aggregate production quotas are sufficient to meet the current
2004 estimated medical, scientific, research, and industrial needs of
the United States and to provide for adequate inventories.
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 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
2004 final aggregate production quotas for the following controlled
substances, expressed in grams of anhydrous acid or base, be
established as follows:
[[Page 67173]]
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Established final
Basic class 2004 quotas
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Schedule I
------------------------------------------------------------------------
2,5-Dimethoxyamphetamine............................. 3,501,000
2,5-Dimethoxy-4-ethylamphetamine (DOET).............. 2
2,5-Dimethoxy-4-n-proplythiophenetyhlamine (2C-T-7).. 10
3-Methylfentanyl..................................... 2
3-Methylthiofentanyl................................. 2
3,4-Methylenedioxyamphetamine(MDA)................... 11
3,4-Methylenedioxy-N-ethylamphetamine (MDEA)......... 5
3,4-Methylenedioxymethamphetamine (MDMA)............. 16
3,4,5-Trimethoxyamphetamine.......................... 2
4-Bromo-2,5-Dimethoxyamphetamine (DOB)............... 2
4-Bromo-2,5-Dimethoxyphenethylamine (2-CB)........... 2
4-Methoxyamphetamine................................. 2
4-Methylaminorex..................................... 2
4-Methyl-2,5-Dimethoxyamphetamine (DOM).............. 2
5-Methoxy-3,4-Methylenedioxyamphetamine.............. 2
5-Methoxy-N,N-diisopropyltryptamine (5-MeO-DIPT)..... 10
Acetyl-alpha-methylfentanyl.......................... 2
Acetyldihydrocodeine................................. 2
Acetylmethadol....................................... 2
Allylprodine......................................... 4
Alphacetylmethadol................................... 2
Alpha-ethyltryptamine................................ 2
Alphameprodine....................................... 2
Alphamethadol........................................ 3
Alpha-methyltryptamine (AMT)......................... 10
Alpha-methylfentanyl................................. 2
Alpha-methylthiofentanyl............................. 2
Aminorex............................................. 2
Benzylmorphine....................................... 2
Betacetylmethadol.................................... 2
Beta-hydroxy-3-methylfentanyl........................ 2
Beta-hydroxyfentanyl................................. 2
Betameprodine........................................ 2
Betamethadol......................................... 2
Betaprodine.......................................... 2
Bufotenine........................................... 2
Cathinone............................................ 2
Codeine-N-oxide...................................... 502
Diethyltryptamine.................................... 2
Difenoxin............................................ 8,000
Dihydromorphine...................................... 1,101,000
Dimethyltryptamine................................... 3
Gamma-hydroxybutyric acid............................ 8,000,000
Heroin............................................... 5
Hydromorphinol....................................... 2
Hydroxypethidine..................................... 2
Lysergic acid diethylamide (LSD)..................... 61
Marihuana............................................ 840,020
Mescaline............................................ 2
Methaqualone......................................... 5
Methcathinone........................................ 4
Methyldihydromorphine................................ 2
Morphine-N-oxide..................................... 502
N,N-Dimethylamphetamine.............................. 2
N-Ethyl-1-Phenylcyclohexylamine (PCE)................ 5
N-Ethylamphetamine................................... 7
N-Hydroxy-3,4-Methylenedioxyamphetamine.............. 2
Noracymethadol....................................... 2
Norlevorphanol....................................... 52
Normethadone......................................... 2
Normorphine.......................................... 12
Para-fluorofentanyl.................................. 2
Phenomorphan......................................... 2
Pholcodine........................................... 2
Propiram............................................. 210,000
Psilocybin........................................... 2
Psilocyn............................................. 2
Tetrahydrocannabinols................................ 180,000
Thiofentanyl......................................... 2
Trimeperidine........................................ 2
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[[Page 67174]]
Schedule II
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1-Phenylcyclohexylamine.............................. 2
1-Piperidinocyclohexanecarbonitrile (PCC)............ 10
Alfentanil........................................... 2,000
Alphaprodine......................................... 2
Amobarbital.......................................... 3
Amphetamine.......................................... 12,700,000
Cocaine.............................................. 200,000
Codeine (for sale)................................... 41,341,000
Codeine (for conversion)............................. 48,252,000
Dextropropoxyphene................................... 167,365,000
Dihydrocodeine....................................... 776,000
Diphenoxylate........................................ 836,000
Ecgonine............................................. 38,000
Ethylmorphine........................................ 2
Fentanyl............................................. 1,428,000
Glutethimide......................................... 2
Hydrocodone (for sale)............................... 34,000,000
Hydrocodone (for conversion)......................... 1,500,000
Hydromorphone........................................ 1,724,000
Isomethadone......................................... 2
Levo-alphacetylmethadol (LAAM)....................... 2
Levomethorphan....................................... 2
Levorphanol.......................................... 15,000
Meperidine........................................... 9,753,000
Metazocine........................................... 1
Methadone (for sale)................................. 14,720,000
Methadone Intermediate............................... 18,296,000
Methamphetamine [675,000 grams of levo- 2,250,000
desoxyephedrine for use in a non-controlled, non-
prescription product; 1,525,000 grams for
methamphetamine mostly for conversion to a Schedule
III product; and 50,000 grams for methamphetamine
(for sale)].........................................
Methylphenidate...................................... 28,693,000
Morphine (for sale).................................. 35,021,000
Morphine (for conversion)............................ 110,774,000
Nabilone............................................. 2
Noroxymorphone (for sale)............................ 99,000
Noroxymorphone (for conversion)...................... 3,800,000
Opium................................................ 1,300,000
Oxycodone (for sale)................................. 49,200,000
Oxycodone (for conversion)........................... 920,000
Oxymorphone.......................................... 534,000
Pentobarbital........................................ 18,251,000
Phencyclidine........................................ 2,060
Phenmetrazine........................................ 2
Phenylacetone........................................ 11,000,000
Racemethorphan....................................... 2
Secobarbital......................................... 2
Sufentanil........................................... 4,000
Thebaine............................................. 72,453,000
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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 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 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 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
[[Page 67175]]
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: November 5, 2004.
Michele M. Leonhart,
Deputy Administrator.
[FR Doc. 04-25340 Filed 11-15-04; 8:45 am]
BILLING CODE 4410-09-P