[Federal Register Volume 73, Number 249 (Monday, December 29, 2008)]
[Notices]
[Pages 79514-79518]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E8-30807]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[DEA  317E]


Controlled Substances: Established Initial Aggregate Production 
Quotas for 2009

AGENCY: Drug Enforcement Administration (DEA), Justice.

ACTION: Notice of aggregate production quotas for 2009.

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SUMMARY: This notice establishes initial 2009 aggregate production 
quotas for

[[Page 79515]]

controlled substances in schedules I and II of the Controlled 
Substances Act (CSA).

DATES: Effective Date: December 29, 2008.

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 2009 aggregate production quotas represent those quantities of 
controlled substances that may be produced in the United States in 2009 
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 November 7, 2008, a notice of the proposed initial 2009 
aggregate production quotas for certain controlled substances in 
schedules I and II was published in the Federal Register (73 FR 66256). 
All interested persons were invited to comment on or object to these 
proposed aggregate production quotas on or before December 8, 2008.
    Six responses were received within the published comment period, 
offering comments on a total of 20 schedule I and II controlled 
substances. The commenters stated that the proposed aggregate 
production quotas for 1-piperdinocyclohexanecarbonitrile, codeine (for 
sale), difenoxin, dihydromorphine, gamma hydroxybutyric acid, 
hydromorphone, meperidine, merperidine intermediate A, meperidine 
intermediate B, meperidine intermediate C, methadone, methadone 
intermediate, methamphetamine (for conversion), methylphenidate, 
morphine (for sale), nabilone, N-benzylpiperazine, oxycodone (for 
sale), 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.
    One of the commenters also stated that publication of the proposed 
aggregate production quotas in November leaves insufficient time to 
consider comments and further commented that DEA has not complied with 
the requirement of 21 U.S.C. 826(c) to establish manufacturing quota 
for individual companies by October 1 for the entire calendar year.
    DEA is unable to issue individual manufacturing quotas until the 
initial aggregate production quotas have been established. DEA strives 
to publish all Federal Register notices pertaining to the aggregate 
production quotas as early as possible, but is limited by the 
timeliness and availability of information utilized by the agency in 
establishing the aggregate production quotas. The publication of the 
aggregate production quotas was delayed, in part, due to incomplete and 
late submissions of manufacturer year-end inventories and untimely 
procurement and manufacturing quota applications. In addition, DEA had 
to give priority to the current manufacturing and procurement quota 
requests to ensure the maintenance of an uninterrupted supply in 2008.
    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 2008 factors, including 2008 
manufacturing quotas, current 2008 sales and inventories, 2009 export 
requirements, additional applications received, and research and 
product development requirements. Based on this information, DEA has 
adjusted the initial aggregate production quotas for 1-
piperdinocyclohexanecarbonitrile, difenoxin, gamma hydroxybutyric acid, 
meperidine intermediate A, meperidine intermediate B, meperidine 
intermediate C, nabilone, N-benzylpiperazine and oxycodone (for sale) 
to meet the legitimate needs of the United States.
    Regarding codeine (for sale), dihydromorphine, hydromorphone, 
methadone, methadone intermediate, methamphetamine (for conversion), 
morphine (for sale), tetrahydrocannabinols, and thebaine, DEA has 
determined that the proposed initial 2009 aggregate production quotas 
are sufficient to meet the current 2009 estimated medical, scientific, 
research and industrial needs of the United States.
    Pursuant to 21 CFR 1303, the Deputy Administrator of DEA will, in 
2009, adjust aggregate production quotas and individual manufacturing 
quotas allocated for the year based upon 2008 year-end inventory and 
actual 2008 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 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 2009 initial aggregate production quotas for the 
following controlled substances, expressed in grams of anhydrous acid 
or base, be established as follows:

------------------------------------------------------------------------
                                                        Established 2009
                Basic class--Schedule I                      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 (MDEA)..........              10 g
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..................................              27 g
4-Methylaminorex......................................               2 g
4-Methyl-2,5-dimethoxyamphetamine (DOM)...............               2 g

[[Page 79516]]

 
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
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.......................................       2,549,000 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)......................              10 g
Marihuana.............................................       4,500,000 g
Mescaline.............................................               7 g
Methaqualone..........................................               5 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
------------------------------------------------------------------------


------------------------------------------------------------------------
                                                        Established 2009
               Basic class--Schedule II                      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)..........................       5,000,000 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

[[Page 79517]]

 
Ethylmorphine.........................................               2 g
Fentanyl..............................................       1,428,000 g
Glutethimide..........................................               2 g
Hydrocodone (for sale)................................      55,000,000 g
Hydromorphone.........................................       3,300,000 g
Isomethadone..........................................               2 g
Levo-alphacetylmethadol (LAAM)........................               3 g
Levomethorphan........................................               5 g
Levorphanol...........................................          10,000 g
Lisdexamfetamine......................................       6,200,000 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
[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.......................................      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)........................................       1,050,000 g
Opium (tincture)......................................         230,000 g
Oripavine.............................................      15,000,000 g
Oxycodone (for sale)..................................      77,560,000 g
Oxycodone (for conversion)............................       3,400,000 g
Oxymorphone (for sale)................................       2,000,000 g
Oxymorphone (for conversion)..........................      12,000,000 g
Pentobarbital.........................................      28,000,000 g
Phenazocine...........................................               1 g
Phencyclidine.........................................              20 g
Phenmetrazine.........................................               2 g
Phenylacetone.........................................               1 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 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.


[[Page 79518]]


    Dated: December 19, 2008.
Michele M. Leonhart,
Deputy Administrator.
[FR Doc. E8-30807 Filed 12-24-08; 8:45 am]
BILLING CODE 4410-09-P