[Federal Register Volume 74, Number 202 (Wednesday, October 21, 2009)]
[Notices]
[Pages 54077-54080]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E9-25274]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. DEA-317F]


Controlled Substances: Final Revised Aggregate Production Quotas 
for 2009

AGENCY: Drug Enforcement Administration (DEA), Justice.

ACTION: Notice of final aggregate production quotas for 2009.

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SUMMARY: This notice establishes final 2009 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 2009 published July 23, 2009 (74 FR 36511).

DATES: Effective Date: October 21, 2009.

FOR FURTHER INFORMATION CONTACT: Christine A. Sannerud, Ph.D, Chief, 
Drug and Chemical Evaluation Section, Drug Enforcement Administration, 
8701 Morrissette Drive, Springfield, Virginia 22152, 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 28 CFR 0.104.
    The 2009 aggregate production quotas represent those quantities of 
controlled substances in schedules I and II 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.
    On July 23, 2009, a notice of the proposed revised 2009 aggregate 
production quotas for certain controlled substances in schedules I and 
II was published in the Federal Register (74 FR 36511). All interested 
persons were invited to comment on or object to these proposed 
aggregate production quotas on or before August 24, 2009.
    Seven companies commented on a total of 18 schedules I and II 
controlled substances within the published comment period. Seven 
companies proposed that the aggregate production quotas for amphetamine 
(for sale), codeine (for conversion), dihydromorphine, fentanyl, 
hydrocodone (for sale), hydromorphone, lisdexamfetamine, methadone, 
methadone intermediate, methamphetamine (for sale), methylphenidate, 
nabilone, opium (tincture), oxycodone (for sale), oxycodone (for 
conversion), oxymorphone (for sale), phenylacetone, 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 2008 year-end inventories, initial 2009 manufacturing quotas, 
2009 export requirements, actual and projected 2009 sales, research, 
product development requirements, and additional applications received. 
Based on this information, the DEA has adjusted the final 2009 
aggregate production quotas for amphetamine (for conversion), 
dihydromorphine, hydrocodone (for sale), hydromorphone, 
lisdexamfetamine, morphine (for sale), opium (tincture), oxycodone (for 
sale), oxycodone (for conversion), oxymorphone (for sale), and 
phenylacetone to meet the legitimate needs of the United States.
    Regarding amphetamine (for sale), codeine (for conversion), 
fentanyl, methadone, methadone intermediate, methamphetamine (for 
sale), methylphenidate, nabilone, and thebaine, the DEA has determined 
that the proposed revised 2009 aggregate production quotas are 
sufficient to meet the current 2009 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. Sec.  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 2009 final aggregate production quotas for the 
following controlled substances,

[[Page 54078]]

expressed in grams of anhydrous acid or base, be established as 
follows:

------------------------------------------------------------------------
          Basic class--Schedule I             Final revised 2009 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......................                          27 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
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...........................                   3,132,000 g
Dimethyltryptamine........................                           3 g
Gamma-hydroxybutyric acid.................                   24,200,00 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
------------------------------------------------------------------------


[[Page 54079]]


------------------------------------------------------------------------
         Basic class--Schedule II             Final revised 2009 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)..............                   7,500,000 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)....................                  55,500,000 g
Hydromorphone.............................                   3,340,000 g
Isomethadone..............................                           2 g
Levo-alphacetylmethadol (LAAM)............                           3 g
Levomethorphan............................                           5 g
Levorphanol...............................                      10,000 g
Lisdexamfetamine..........................                   8,200,000 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
Methylphenidate...........................                  50,000,000 g
Morphine (for sale).......................                  36,300,000 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)..........................                   1,250,000 g
Oripavine.................................                  15,000,000 g
Oxycodone (for sale)......................                  94,000,000 g
Oxycodone (for conversion)................                   4,500,000 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.............................                     250,001 g
Racemethorphan............................                           2 g
Remifentanil..............................                         500 g
Secobarbital..............................                      67,000 g
Sufentanil................................                      10,300 g
Thebaine..................................                 126,000,000 g
------------------------------------------------------------------------

    DEA proposed the aggregate production quota for tapentadol at 
519,000 g in the 2009 proposed revised aggregate production quota 
notice published on July 23, 2009, in the Federal Register (74 FR 
36511). Tapentadol is no longer listed because the material will be 
imported into the United States and not manufactured domestically.
    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 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

[[Page 54080]]

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.

    Dated: October 13, 2009.
Michele M. Leonhart,
Deputy Administrator.
[FR Doc. E9-25274 Filed 10-20-09; 8:45 am]
BILLING CODE 4410-09-P