[Federal Register Volume 74, Number 202 (Wednesday, October 21, 2009)]
[Notices]
[Pages 54080-54083]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E9-25275]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[DEA  318E]


Controlled Substances: Established Initial Aggregate Production 
Quotas for 2010

AGENCY: Drug Enforcement Administration (DEA), Justice.

ACTION: Notice of aggregate production quotas for 2010.

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SUMMARY: This notice establishes initial 2010 aggregate production 
quotas for controlled substances in schedules I and II of the 
Controlled Substances Act (CSA).

DATES: Effective Date: October 21, 2009.

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 (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 2010 aggregate production quotas represent those quantities of 
controlled substances that may be produced in the United States in 2010 
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 May 21, 2009, a notice of the proposed initial 2010 aggregate 
production quotas for certain controlled substances in schedules I and 
II was published in the Federal Register (74 FR 23881). All interested 
persons were invited to comment on or object to these proposed 
aggregate production quotas on or before June 22, 2009.
    Twelve responses (eleven from DEA registered manufacturers, and one 
from a non-DEA registrant) were received within the published comment 
period, offering comments on a total of 28 schedule I and II controlled 
substances. One additional comment was received after the comment 
period ended and therefore was not considered. The commenters stated 
that the proposed aggregate production quotas for 3,4-
methylenedioxyamphetamine, 3,4-methylenedioxyethylamphetamine, 3,4-
methylenedioxymethamphetamine, alfentanil, amphetamine (for sale), 
codeine (for sale), codeine (for conversion), dihydromorphine, 
fentanyl, gamma hydroxybutyric acid, hydrocodone, hydromorphone, 
isomethadone, levo-desoxyephedrine, levorphanol, lisdexamfetamine, 
methamphetamine (for sale), morphine (for conversion), nabilone, opium 
(tincture), oxycodone (for sale), oxycodone (for conversion), 
oxymorphone (for sale), remifentanil, sufentanil, tapentadol, 
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.
    In arriving at the aggregate production quotas, DEA has taken into 
consideration the above comments along with the factors set forth at 21 
CFR 1303.11(b) and other relevant 2009 factors, including 2009 
manufacturing quotas, current 2009 sales and inventories, 2010 export 
requirements, additional applications received, and research and 
product development requirements. Based on this information, DEA has 
adjusted the initial aggregate production quotas for 4-
methoxyamphetamine, alpha-methyltryptamine, amphetamine (for 
conversion), dihydromorphine, isomethadone, levo-desoxyephedrine, 
lisdexamfetamine, lysergic acid diethylamide, methamphetamine (for 
sale), methamphetamine (for conversion), methaqualone, oxycodone (for 
sale), oxycodone (for conversion), oxymorphone (for sale) and 
phenylacetone to meet the legitimate needs of the United States.
    DEA proposed the aggregate production quota for tapentadol at 
519,000 g in the 2010 proposed initial aggregate production quota 
notice published on May 21, 2009 in the Federal Register (74 FR 23881). 
Tapentadol is no longer listed because the material will be imported 
into the United States and not manufactured domestically.
    Regarding 3,4-methylenedioxyamphetamine, 3,4-
methylenedioxyethylamphetamine, 3,4-methylenedioxymethamphetamine, 
alfentanil, amphetamine (for sale), codeine (for sale), codeine (for 
conversion), fentanyl, gamma hydroxybutyric acid, hydrocodone, 
hydromorphone, levorphanol, morphine (for conversion), nabilone, opium 
(tincture), remifentanil, sufentanil, tetrahydrocannabinols, and 
thebaine DEA has determined that the proposed initial 2010 aggregate 
production quotas are sufficient to meet the current 2010 estimated 
medical, scientific, research and industrial needs of the United 
States.
    Pursuant to 21 CFR 1303, the Deputy Administrator of DEA will, in 
2010, adjust aggregate production quotas and individual manufacturing 
quotas allocated for the year based upon 2009 year-end inventory and 
actual 2009 disposition data supplied by quota recipients for each 
basic class of schedule I or II controlled substance.

[[Page 54081]]

    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 DEA by 28 CFR Sec.  0.100, and redelegated to the 
Deputy Administrator pursuant to 28 CFR 0.104, the Deputy Administrator 
hereby orders that the 2010 initial aggregate production quotas for the 
following controlled substances, expressed in grams of anhydrous acid 
or base, be established as follows:

------------------------------------------------------------------------
          Basic class--Schedule I              Established 2010 quotas
------------------------------------------------------------------------
2,5-Dimethoxyamphetamine..................                           2 g
2,5-Dimethoxy-4-ethylamphetamine (DOET)...                           2 g
3-Methylfentanyl..........................                           2 g
3-Methylthiofentanyl......................                           2 g
3,4-Methylenedioxyamphetamine (MDA).......                          25 g
3,4-Methylenedioxy-N-ethylamphetamine                               10 g
 (MDEA)...................................
3,4-Methylenedioxymethamphetamine (MDMA)..                          20 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
4-Methylaminorex..........................                           2 g
4-Methyl-2,5-dimethoxyamphetamine (DOM)...                           2 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.............................                           2 g
Alpha-methylfentanyl......................                           2 g
Alpha-methylthiofentanyl..................                           2 g
Alpha-methyltryptamine....................                           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................................                           3 g
Cathinone.................................                           3 g
Codeine-N-oxide...........................                         602 g
Diethyltryptamine.........................                           2 g
Difenoxin.................................                       3,000 g
Dihydromorphine...........................                   3,300,000 g
Dimethyltryptamine........................                           3 g
Gamma-hydroxybutyric acid.................                  24,200,000 g
Heroin....................................                          20 g
Hydromorphinol............................                           2 g
Hydroxypethidine..........................                           2 g
Ibogaine..................................                           1 g
Lysergic acid diethylamide (LSD)..........                          15 g
Marihuana.................................                   4,500,000 g
Mescaline.................................                           7 g
Methaqualone..............................                           7 g
Methcathinone.............................                           4 g
Methyldihydromorphine.....................                           2 g
Morphine-N-oxide..........................                         605 g
N-Benzylpiperazine........................                           2 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.....................                     312,500 g
Thiofentanyl..............................                           2 g
Trimeperidine.............................                           2 g
------------------------------------------------------------------------


[[Page 54082]]


------------------------------------------------------------------------
         Basic class--Schedule II              Established 2010 quotas
------------------------------------------------------------------------
1-Phenylcyclohexylamine...................                           2 g
1-piperdinocyclohexanecarbonitrile........                           2 g
Alfentanil................................                       8,000 g
Alphaprodine..............................                           2 g
Amobarbital...............................                           3 g
Amphetamine (for sale)....................                  17,000,000 g
Amphetamine (for conversion)..............                   6,500,000 g
Cocaine...................................                     247,000 g
Codeine (for sale)........................                  39,605,000 g
Codeine (for conversion)..................                  65,000,000 g
Dextropropoxyphene........................                 106,000,000 g
Dihydrocodeine............................                   1,200,000 g
Diphenoxylate.............................                     947,000 g
Ecgonine..................................                      83,000 g
Ethylmorphine.............................                           2 g
Fentanyl..................................                   1,428,000 g
Glutethimide..............................                           2 g
Hydrocodone (for sale)....................                  55,000,000 g
Hydromorphone.............................                   3,300,000 g
Isomethadone..............................                          11 g
Levo-alphacetylmethadol (LAAM)............                           3 g
Levomethorphan............................                           5 g
Levorphanol...............................                      10,000 g
Lisdexamfetamine..........................                   9,000,000 g
Meperidine................................                   8,600,000 g
Meperidine Intermediate-A.................                           3 g
Meperidine Intermediate-B.................                           7 g
Meperidine Intermediate-C.................                           3 g
Metazocine................................                           1 g
Methadone (for sale)......................                  25,000,000 g
Methadone Intermediate....................                  26,000,000 g
Methamphetamine...........................                   3,130,000 g
------------------------------------------------------------------------
[750,000 grams of levo-desoxyephedrine for use in a non-controlled, non-
  prescription product; 2,331,000 grams for methamphetamine mostly for
       conversion to a schedule III product; and 49,000 grams for
                       methamphetamine (for sale)]
------------------------------------------------------------------------
Methylphenidate...........................                  50,000,000 g
Morphine (for sale).......................                  35,000,000 g
Morphine (for conversion).................                 100,000,000 g
Nabilone..................................                       9,002 g
Noroxymorphone (for sale).................                      10,000 g
Noroxymorphone (for conversion)...........                   9,000,000 g
Opium (powder)............................                     230,000 g
Opium (tincture)..........................                   1,050,000 g
Oripavine.................................                  15,000,000 g
Oxycodone (for sale)......................                  88,000,000 g
Oxycodone (for conversion)................                   4,000,000 g
Oxymorphone (for sale)....................                   2,570,000 g
Oxymorphone (for conversion)..............                  12,000,000 g
Pentobarbital.............................                  28,000,000 g
Phenazocine...............................                           1 g
Phencyclidine.............................                          20 g
Phenmetrazine.............................                           2 g
Phenylacetone.............................                  12,500,001 g
Racemethorphan............................                           2 g
Remifentanil..............................                         500 g
Secobarbital..............................                      67,000 g
Sufentanil................................                      10,300 g
Thebaine..................................                 126,000,000 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 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

[[Page 54083]]

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 
$120,000,000 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: October 14, 2009.
Michele M. Leonhart,
Deputy Administrator.
[FR Doc. E9-25275 Filed 10-20-09; 8:45 am]
BILLING CODE 4410-09-P