[Federal Register Volume 71, Number 237 (Monday, December 11, 2006)]
[Notices]
[Pages 71559-71562]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E6-20920]


-----------------------------------------------------------------------

DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[DEA 290E]


Controlled Substances: Established Initial Aggregate Production 
Quotas for 2007

AGENCY: Drug Enforcement Administration (DEA), Justice.

ACTION: Notice of aggregate production quotas for 2007.

-----------------------------------------------------------------------

SUMMARY: This notice establishes initial 2007 aggregate production 
quotas for controlled substances in schedules I and II of the 
Controlled Substances Act (CSA).

DATES: Effective Date: December 11, 2006.

FOR FURTHER INFORMATION CONTACT: Christine A. Sannerud, Ph.D., Chief, 
Drug & 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 section 826 (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 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 2007 aggregate production quotas represent those quantities of 
controlled substances that may be produced in the United States in 2007 
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 for use in 
industrial processes.
    On August 29, 2006, a notice of the proposed initial 2007 aggregate 
production quotas for certain controlled substances in schedules I and 
II was published in the Federal Register (71 FR 51214). All interested 
persons were invited to comment on or object to these proposed 
aggregate production quotas on or before September 19, 2006.
    Five responses were received within the published comment period 
resulting in comments on a total of 25 schedule I and II controlled 
substances. The responses commented that the proposed aggregate 
production quotas for alfentanil, aminorex, cocaine, codeine (for 
conversion), dihydrocodeine, ecgonine, fentanyl, hydrocodone, 
hydromorphone, levorphanol, methadone, methadone intermediate, 
methamphetamine, methylphenidate, morphine (for conversion), nabilone, 
noroxymorphone (for conversion), oxycodone, oxycodone (for conversion), 
oxymorphone, oxymorphone (for conversion), 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 2006 manufacturing quotas, current 2006 sales and inventories, 
2007 export requirements, additional applications received, and 
research and product development requirements. Based on this 
information, the DEA has adjusted the initial aggregate production 
quotas for alfentanil, aminorex, amobarbital, codeine (for conversion), 
dextropropoxyphene, dihydrocodeine, gamma hydroxybutyric acid, 
ibogaine, hydrocodone, metazocine, nabilone, noroxymorphone (for 
conversion), oxycodone, oxycodone (for conversion), oxymorphone, 
oxymorphone (for conversion), remifentanil, sufentanil,

[[Page 71560]]

and thebaine to meet the legitimate needs of the United States.
    Regarding cocaine, ecgonine, fentanyl, hydromorphone, levorphanol, 
methadone, methadone intermediate, methamphetamine, methylphenidate, 
morphine (for conversion) and tetrahydrocannabinols, the DEA has 
determined that the proposed initial 2007 aggregate production quotas 
are sufficient to meet the current 2007 estimated medical, scientific, 
research and industrial needs of the United States.
    Pursuant to 21 CFR Part 1303, the Deputy Administrator of the DEA 
will, in 2007, adjust aggregate production quotas and individual 
manufacturing quotas allocated for the year based upon 2006 year-end 
inventory and actual 2006 disposition data supplied by quota recipients 
for each basic class of schedule I or II controlled substance.
    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 2007 initial aggregate production quotas for the 
following controlled substances, expressed in grams of anhydrous acid 
or base, be established as follows:

------------------------------------------------------------------------
                                               Established initial 2007
           Basic Class--Schedule I                      quotas
------------------------------------------------------------------------
2,5-Dimethoxyamphetamine....................  2,001,000 g
2,5-Dimethoxy-4-ethylamphetamine (DOET).....  2 g
2,5-Dimethoxy-4-(n)-propylthiophenethylamine  10 g
 (2C-T-7).
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)..  7 g
4-Methoxyamphetamine........................  77 g
4-Methylaminorex............................  2 g
4-Methyl-2,5-dimethoxyamphetamine (DOM).....  12 g
5-Methoxy-3,4-methylenedioxyamphetamine.....  2 g
5-Methoxy-N,N-diisopropyltryptamine.........  5 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
Alpha-methyltryptamine......................  5 g
Aminorex....................................  8 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..................................  8 g
Cathinone...................................  3 g
Codeine-N-oxide.............................  302 g
Diethyltryptamine...........................  2 g
Difenoxin...................................  50 g
Dihydromorphine.............................  2,549,000 g
Dimethyltryptamine..........................  3 g
Gamma-hydroxybutyric acid...................  13,100,000 g
Heroin......................................  5 g
Hydromorphinol..............................  3,000 g
Hydroxypethidine............................  2 g
Ibogaine....................................  1 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

[[Page 71561]]

 
Normethadone................................  2 g
Normorphine.................................  16 g
Para-fluorofentanyl.........................  2 g
Phenomorphan................................  2 g
Pholcodine..................................  2 g
Psilocybin..................................  7 g
Psilocyn....................................  7 g
Tetrahydrocannabinols.......................  312,500 g
Thiofentanyl................................  2 g
Trimeperidine...............................  2 g
------------------------------------------------------------------------


------------------------------------------------------------------------
                                               Established initial 2007
          Basic Class--Schedule II                      quotas
------------------------------------------------------------------------
1-Phenylcyclohexylamine.....................  2 g
Alfentanil..................................  7,200 g
Alphaprodine................................  2 g
Amobarbital.................................  3 g
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..............................  2,435,000 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...............................  3,300,000 g
Isomethadone................................  2 g
Levo-alphacetylmethadol (LAAM)..............  6 g
Levomethorphan..............................  5 g
Levorphanol.................................  6,000 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)...................  110,774,000 g
Nabilone....................................  3,002 g
Noroxymorphone (for sale)...................  1,002 g
Noroxymorphone (for conversion).............  11,000,000 g
Opium.......................................  1,400,000 g
Oxycodone (for sale)........................  56,000,000 g
Oxycodone (for conversion)..................  25,000,000 g
Oxymorphone.................................  1,800,000 g
Oxymorphone (for conversion)................  15,300,000 g
Pentobarbital...............................  28,000,000 g
Phencyclidine...............................  2,021 g
Phenmetrazine...............................  2 g
Racemethorphan..............................  2 g
Remifentanil................................  5,000 g
Secobarbital................................  2 g
Sufentanil..................................  12,300 g
Thebaine....................................  102,000,000 g
------------------------------------------------------------------------

    The Deputy Administrator further orders that aggregate production 
quotas for all other schedules I and II controlled substances included 
in 21 CFR 1308.11 and 1308.12 be established 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

[[Page 71562]]

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

    Dated: December 1, 2006.
Michele M. Leonhart,
Deputy Administrator.
 [FR Doc. E6-20920 Filed 12-8-06; 8:45 am]
BILLING CODE 4410-09-P