[Federal Register Volume 70, Number 216 (Wednesday, November 9, 2005)]
[Notices]
[Pages 68088-68090]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 05-22287]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. DEA-259F]


Controlled Substances: Final Revised Aggregate Production Quotas 
for 2005

AGENCY: Drug Enforcement Administration (DEA), Department of Justice.

ACTION: Notice of final aggregate production quotas for 2005.

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SUMMARY: This notice establishes final 2005 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 2005 published August 5, 2005 (70 FR 45432).

EFFECTIVE DATE: November 9, 2005.

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 28 CFR 0.100. The Administrator, in turn, has redelegated 
this function to the Deputy Administrator, pursuant to 28 CFR 0.104.
    The 2005 aggregate production quotas represent those quantities of 
controlled substances in Schedules I and II that may be produced in the 
United States in 2005 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 5, 2005, a notice of the proposed revised 2005 aggregate 
production quotas for certain controlled substances in Schedules I and 
II was published in the Federal Register (70 FR 45432). All interested 
persons were invited to comment on or object to these proposed 
aggregate production quotas on or before August 26, 2005.
    Nine companies commented on a total of 21 Schedules I and II 
controlled substances within the published comment period. One company 
questioned the aggregate production quota for marihuana. Eight 
companies proposed the aggregate production quotas for alfentanil, 
amphetamine, codeine (for conversion), difenoxin, dihydromorphine, 
diphenoxylate, fentanyl, hydrocodone, hydromorphone, levo-
desoxyephedrine, methadone, methadone intermediate, methylphenidate, 
morphine (for sale), oxycodone, pentobarbital, remifentanil, 
sufentanil, 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 2004 year-end inventories, initial 2005 manufacturing quotas, 
2005 export requirements, actual and projected 2005 sales, research, 
product development requirements and additional applications received. 
Based on this information, the DEA has adjusted the final 2005 
aggregate production quotas for alfentanil, cathinone, dihydromorphine, 
diphenoxylate, levo-alphacetylmethadol, levo-desoxyephedrine, 
methadone, methadone intermediate, oxycodone, pentobarbital and 
sufentanil to meet the legitimate needs of the United States.
    Regarding amphetamine, codeine (for conversion), difenoxin, 
fentanyl, hydrocodone, hydromorphone, marihuana, methylphenidate, 
morphine (for sale), remifentanil, tetrahydrocannabinols and thebaine 
the DEA has determined that the proposed revised 2005 aggregate 
production quotas are sufficient to meet the current 2005 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 Sec.  0.100 of Title 
28 of the Code of Federal Regulations, and redelegated to the Deputy 
Administrator, pursuant to Sec.  0.104 of Title 28 of the Code of 
Federal Regulations, the Deputy Administrator hereby orders that the 
2005 final aggregate production quotas for the following controlled 
substances, expressed in grams of anhydrous acid or base, be 
established as follows:

------------------------------------------------------------------------
                                                           Final Revised
                 Basic Class--Schedule I                    2005 Quotas
                                                                (g)
------------------------------------------------------------------------
2,5-Dimethoxyamphetamine................................       2,801,000
2,5-Dimethoxy-4-ethylamphetamine (DOET).................               2
2,5-Dimethoxy-4-(n)-propylthiophenethylamine............              10
3-Methylfentanyl........................................               2
3-Methylthiofentanyl....................................               2
3,4-Methylenedioxyamphetamine (MDA).....................              15
3,4-Methylenedioxy-N-ethylamphetamine (MDEA)............               5
3,4-Methylenedioxymethamphetamine (MDMA)................              17
3,4,5-Trimethoxyamphetamine.............................               2
4-Bromo-2,5-dimethoxyamphetamine (DOB)..................               2
4-Bromo-2,5-dimethoxyphenethylamine (2-CB)..............               2
4-Methoxyamphetamine....................................               5
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............................................               2
Alphacetylmethadol......................................               2
Alpha-ethyltryptamine...................................               2
Alphameprodine..........................................               2
Alphamethadol...........................................               3
Alpha-methyltryptamine (AMT)............................              10

[[Page 68089]]

 
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...............................................               3
Codeine-N-oxide.........................................             252
Diethyltryptamine.......................................               2
Difenoxin...............................................           5,000
Dihydromorphine.........................................       2,046,000
Dimethyltryptamine......................................               3
Gamma-hydroxybutyric acid...............................       8,000,000
Heroin..................................................               2
Hydromorphinol..........................................               2
Hydroxypethidine........................................               2
Lysergic acid diethylamide (LSD)........................              61
Marihuana...............................................       4,500,000
Mescaline...............................................               2
Methaqualone............................................               5
Methcathinone...........................................               4
Methyldihydromorphine...................................               2
Morphine-N-oxide........................................             252
N,N-Dimethylamphetamine.................................               2
N-Ethylamphetamine......................................               2
N-Hydroxy-3,4-methylenedioxyamphetamine.................               2
Noracymethadol..........................................               2
Norlevorphanol..........................................              52
Normethadone............................................               2
Normorphine.............................................              12
Para-fluorofentanyl.....................................               2
Phenomorphan............................................               2
Pholcodine..............................................               2
Propiram................................................          50,000
Psilocybin..............................................               2
Psilocyn................................................               7
Tetrahydrocannabinols...................................         312,500
Thiofentanyl............................................               2
Trimeperidine...........................................               2
------------------------------------------------------------------------


------------------------------------------------------------------------
                                                        Proposed Revised
               Basic Class--Schedule II                 2005 Quotas  (g)
------------------------------------------------------------------------
1-Phenylcyclohexylamine..............................                  2
Alfentanil...........................................              2,800
Alphaprodine.........................................                  2
Amobarbital..........................................                  2
Amphetamine..........................................         14,500,000
Cocaine..............................................            228,000
Codeine (for sale)...................................         39,605,000
Codeine (for conversion).............................         55,000,000
Dextropropoxyphene...................................        167,365,000
Dihydrocodeine.......................................            750,000
Diphenoxylate........................................            833,000
Ecgonine.............................................             73,000
Ethylmorphine........................................                  2
Fentanyl.............................................          1,428,000
Glutethimide.........................................                  2
Hydrocodone (for sale)...............................         37,604,000
Hydrocodone (for conversion).........................          1,500,000
Hydromorphone........................................          3,300,000
Isomethadone.........................................                  2
Levo-alphacetylmethadol (LAAM).......................                  3
Levomethorphan.......................................                  2
Levorphanol..........................................              5,000
Meperidine...........................................          9,753,000
Metazocine...........................................                  1
Methadone (for sale).................................         17,940,000
Methadone Intermediate...............................         20,334,000
Methamphetamine [700,000 grams of levo-                        2,360,000
 desoxyephedrine for use in a non-controlled, non-
 prescription product; 1,615,000 grams for
 methamphetamine mostly for conversion to a Schedule
 III product; and 45,000 grams for methamphetamine
 (for sale)].........................................
Methylphenidate......................................         35,000,000
Morphine (for sale)..................................         35,000,000
Morphine (for conversion)............................        110,774,000
Nabilone.............................................                  2
Noroxymorphone (for sale)............................              1,002
Noroxymorphone (for conversion)......................          4,000,000
Opium................................................          1,280,000
Oxycodone (for sale).................................         50,490,000
Oxycodone (for conversion)...........................            920,000
Oxymorphone..........................................            534,000
Pentobarbital........................................         20,335,000
Phencyclidine........................................              2,006
Phenmetrazine........................................                  2
Racemethorphan.......................................                  2
Remifentanil.........................................              1,800
Secobarbital.........................................                  2
Sufentanil...........................................              4,500
Thebaine.............................................         72,453,000
------------------------------------------------------------------------


[[Page 68090]]

    The Deputy Administrator further orders that aggregate production 
quotas for all other Schedules I and II controlled substances included 
in Sec. Sec.  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 
$117,000,000 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.

    Dated: November 3, 2005.
Michele M. Leonhart,
Deputy Administrator.
[FR Doc. 05-22287 Filed 11-8-05; 8:45 am]
BILLING CODE 4410-09-P