[Federal Register Volume 71, Number 202 (Thursday, October 19, 2006)]
[Notices]
[Pages 61803-61806]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E6-17524]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. DEA-270F]


Controlled Substances: Final Revised Aggregate Production Quotas 
for 2006

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

ACTION: Notice of final aggregate production quotas for 2006.

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SUMMARY: This notice establishes final 2006 aggregate production quotas 
for controlled substances in Schedules I and II of the Controlled 
Substances Act of 1970 (CSA). The DEA has taken into consideration 
comments received in response to a notice of the proposed revised 
aggregate production quotas for 2006 published July 5, 2006 (71 FR 
38174).

EFFECTIVE DATE: October 19, 2006.

FOR FURTHER INFORMATION CONTACT: Christine A. Sannerud, PhD, Chief, 
Drug and Chemical Evaluation Section, Drug Enforcement Administration, 
Washington, DC 20537, Telephone: (202) 307-7183.

SUPPLEMENTARY INFORMATION: Section 306 of the CSA (Title 21 United 
States Code (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 Code of Federal 
Regulations (CFR) 0.100. The Administrator, in turn, has redelegated 
this function to the Deputy Administrator, pursuant to 28 CFR 0.104.
    The 2006 aggregate production quotas represent those quantities of 
controlled substances in Schedules I and II that may be produced in the 
United States in 2006 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 July 5, 2006, a notice of the proposed revised 2006 aggregate 
production quotas for certain controlled substances in Schedules I and 
II was published in the Federal Register (71 FR 38174). All interested 
persons were invited to comment on or object to these proposed 
aggregate production quotas on or before July 26, 2006.
    Eight companies commented on a total of 22 Schedules I and II 
controlled substances within the published comment period. Eight 
companies proposed that the aggregate production quotas for alfentanil, 
amphetamine, codeine (for conversion), dihydrocodeine, dihydromorphine, 
diphenoxylate, fentanyl, gamma hydroxybutyric acid, hydrocodone, 
hydromorphinol, hydromorphone, methadone, methylphenidate, morphine 
(for conversion), N,N-dimethylamphetamine, opium, oxycodone, oxycodone 
(for conversion), oxymorphone, oxymorphone (for conversion), 
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 2005 year-end inventories, initial 2006 manufacturing quotas, 
2006 export requirements, actual and projected 2006 sales, research, 
product development requirements and additional applications received. 
Based on this information, the DEA has adjusted the final 2006 
aggregate production quotas for alfentanil, codeine (for conversion), 
dextropropoxyphene, dihydromorphine, hydrocodone, hydromorphone, 
morphine (for conversion), N,N-dimethylamphetamine, opium, oxycodone, 
oxycodone (for conversion), oxymorphone, oxymorphone (for conversion), 
tetrahydrocannabinols, and thebaine to meet the legitimate needs of the 
United States.
    Regarding amphetamine, dihydrocodeine, diphenoxylate, fentanyl, 
gamma hydroxybutyric acid, hydromorphinol, methadone, and 
methylphenidate, the DEA has determined that the proposed revised 2006 
aggregate production quotas are sufficient to meet the current 2006 
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 CSA (21 U.S.C. 826), and delegated to the 
Administrator of the DEA by 28 CFR 0.100, and redelegated to the Deputy 
Administrator, pursuant to 28 CFR 0.104, the Deputy Administrator 
hereby orders that the 2006 final aggregate production quotas for the 
following controlled substances, expressed in grams of anhydrous acid 
or base, be established as follows:

[[Page 61804]]



------------------------------------------------------------------------
                                                           Final revised
                 Basic class--schedule I                    2006 quotas
------------------------------------------------------------------------
2,5-Dimethoxyamphetamine................................     2,801,000 g
2,5-Dimethoxy-4-ethylamphetamine (DOET).................             2 g
3-Methylfentanyl........................................             2 g
3-Methylthiofentanyl....................................             2 g
3,4-Methylenedioxyamphetamine (MDA).....................            20 g
3,4-Methylenedioxy-N-ethylamphetamine (MDEA)............            10 g
3,4-Methylenedioxymethamphetamine (MDMA)................            22 g
3,4,5-Trimethoxyamphetamine.............................             2 g
4-Bromo-2,5-dimethoxyamphetamine (DOB)..................             2 g
4-Bromo-2,5-dimethoxyphenethylamine (2-CB)..............             2 g
4-Methoxyamphetamine....................................            77 g
g 4-Methylaminorex......................................             2 g
4-Methyl-2,5-dimethoxyamphetamine (DOM).................            12 g
5-Methoxy-3,4-methylenedioxyamphetamine.................             2 g
Acetyl-alpha-methylfentanyl.............................             2 g
Acetyldihydrocodeine....................................             2 g
Acetylmethadol..........................................             2 g
Allylprodine............................................             2 g
Alphacetylmethadol......................................             2 g
Alpha-ethyltryptamine...................................             2 g
Alphameprodine..........................................             2 g
Alphamethadol...........................................             3 g
Alpha-methylfentanyl....................................             2 g
Alpha-methylthiofentanyl................................             2 g
Aminorex................................................             2 g
Benzylmorphine..........................................             2 g
Betacetylmethadol.......................................             2 g
Beta-hydroxy-3-methylfentanyl...........................             2 g
Beta-hydroxyfentanyl....................................             2 g
Betameprodine...........................................             2 g
Betamethadol............................................             2 g
Betaprodine.............................................             2 g
Bufotenine..............................................             5 g
Cathinone...............................................             3 g
Codeine-N-oxide.........................................           302 g
Diethyltryptamine.......................................             2 g
Difenoxin...............................................         5,000 g
Dihydromorphine.........................................     2,449,000 g
Dimethyltryptamine......................................             3 g
Gamma-hydroxybutyric acid...............................     8,000,000 g
Heroin..................................................             5 g
Hydromorphinol..........................................             2 g
Hydroxypethidine........................................             2 g
Lysergic acid diethylamide (LSD)........................            61 g
Marihuana...............................................     4,500,000 g
Mescaline...............................................             2 g
Methaqualone............................................            10 g
Methcathinone...........................................             4 g
Methyldihydromorphine...................................             2 g
Morphine-N-oxide........................................           310 g
N,N-Dimethylamphetamine.................................             7 g
N-Ethylamphetamine......................................             2 g
N-Hydroxy-3,4-methylenedioxyamphetamine.................             2 g
Noracymethadol..........................................             2 g
Norlevorphanol..........................................            52 g
Normethadone............................................             2 g
Normorphine.............................................            16 g
Para-fluorofentanyl.....................................             2 g
Phenomorphan............................................             2 g
Pholcodine..............................................             2 g
Psilocybin..............................................             7 g
Psilocyn................................................             7 g
Tetrahydrocannabinols...................................       338,000 g
Thiofentanyl............................................             2 g
Trimeperidine...........................................             2 g
------------------------------------------------------------------------


------------------------------------------------------------------------
                                                          Final revised
               Basic class--schedule II                    2006 quotas
------------------------------------------------------------------------
1-Phenylcyclohexylamine...............................               2 g
Alfentanil............................................           7,200 g
Alphaprodine..........................................               2 g
Amobarbital...........................................         101,000 g

[[Page 61805]]

 
Amphetamine...........................................      17,000,000 g
Cocaine...............................................         286,000 g
Codeine (for sale)....................................      39,605,000 g
Codeine (for conversion)..............................      59,000,000 g
Dextropropoxyphene....................................     120,000,000 g
Dihydrocodeine........................................       1,261,000 g
Diphenoxylate.........................................         828,000 g
Ecgonine..............................................          83,000 g
Ethylmorphine.........................................               2 g
Fentanyl..............................................       1,428,000 g
Glutethimide..........................................               2 g
Hydrocodone (for sale)................................      42,000,000 g
Hydrocodone (for conversion)..........................       1,500,000 g
Hydromorphone.........................................       2,500,000 g
Isomethadone..........................................               2 g
Levo-alphacetylmethadol (LAAM)........................               6 g
Levomethorphan........................................               5 g
Levorphanol...........................................           5,000 g
Meperidine............................................       9,753,000 g
Metazocine............................................               1 g
Methadone (for sale)..................................      25,000,000 g
Methadone Intermediate................................      26,000,000 g
Methamphetamine.......................................       3,130,000 g
------------------------------------------------------------------------
[680,000 grams of levo-desoxyephedrine for use in a non-controlled, non
 prescription product; 2,405,000 grams for methamphetamine mostly for
 conversion to a Schedule III product; and 45,000 grams for
 methamphetamine (for sale)]
------------------------------------------------------------------------
Methylphenidate.......................................      35,000,000 g
Morphine (for sale)...................................      35,000,000 g
Morphine (for conversion).............................     100,000,000 g
Nabilone..............................................               2 g
Noroxymorphone (for sale).............................           1,002 g
Noroxymorphone (for conversion).......................       5,600,000 g
Opium.................................................       1,360,000 g
Oxycodone (for sale)..................................      56,000,000 g
Oxycodone (for conversion)............................       4,610,000 g
Oxymorphone...........................................         806,000 g
Oxymorphone (for conversion)..........................       2,400,000 g
Pentobarbital.........................................      28,000,000 g
Phencyclidine.........................................           2,021 g
Phenmetrazine.........................................               2 g
Racemethorphan........................................               2 g
Remifentanil..........................................           2,700 g
Secobarbital..........................................               2 g
Sufentanil............................................           6,500 g
Thebaine..............................................      78,000,000 g
------------------------------------------------------------------------

    The Deputy Administrator further orders that the aggregate 
production quotas for all other Schedules I and II controlled 
substances included in 21 CFR 1308.11 and 1308.12 shall be zero.
    The Office of Management and Budget has determined that notices of 
aggregate production quotas are not subject to centralized review under 
Executive Order (E.O.) 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 E.O. 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 E.O. 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 
$118,000,000 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

[[Page 61806]]

ability of United States-based companies to compete with foreign-based 
companies in domestic and export markets.

    Dated: October 13, 2006.
Michele M. Leonhart,
Deputy Administrator. 1
 [FR Doc. E6-17524 Filed 10-18-06; 8:45 am]
BILLING CODE 4410-09-P