[Federal Register Volume 73, Number 219 (Wednesday, November 12, 2008)]
[Notices]
[Pages 66939-66942]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E8-26798]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. DEA-307F]


Controlled Substances: Final Revised Aggregate Production Quotas 
for 2008

AGENCY: Drug Enforcement Administration (DEA), Justice.

ACTION: Notice of final aggregate production quotas for 2008.

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SUMMARY: This notice establishes final 2008 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 2008 published July 1, 2008 (73 FR 37496).

DATES: Effective Date: November 12, 2008.

FOR FURTHER INFORMATION CONTACT: Christine A. Sannerud, PhD, 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 2008 aggregate production quotas represent those quantities of 
controlled substances in schedules I and II that may be produced in the 
United States in 2008 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 1, 2008, a notice of the proposed revised 2008 aggregate 
production quotas for certain controlled substances in schedules I and 
II was published in the Federal Register (73 FR 37496). All interested 
persons were invited to comment on or object to these proposed 
aggregate production quotas on or before July 31, 2008.
    Five companies commented on a total of 25 schedules I and II 
controlled substances within the published comment period. One 
additional comment was received after the comment period ended and 
therefore was not considered. Five companies proposed that the 
aggregate production quotas for amphetamine (for sale), codeine (for 
sale), codeine (for conversion), dextropropoxyphene, dihydromorphine, 
diphenoxylate, fentanyl, gamma-hydroxybutyric acid, hydrocodone (for 
sale), hydromorphone, methadone, methadone intermediate, morphine (for 
sale), morphine (for conversion), nabilone, noroxymorphone (for 
conversion), opium, oripavine, oxycodone (for sale), oxycodone (for 
conversion), oxymorphone (for sale), oxymorphone (for conversion), 
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 2007 year-end inventories, initial 2008 manufacturing quotas, 
2008 export requirements, actual and projected 2008 sales, research, 
product development requirements and additional applications received. 
Based on this information, the DEA has adjusted the final 2008 
aggregate production quotas for codeine (for conversion), 
diphenoxylate, heroin, hydrocodone (for sale), morphine (for 
conversion), nabilone, noroxymorphone (for conversion), oxymorphone 
(for conversion), phenazocine, and phenylacetone to meet the legitimate 
needs of the United States.
    Regarding amphetamine (for sale), codeine (for sale), 
dextropropoxyphene, dihydromorphine, fentanyl, gamma-hydroxybutyric 
acid, hydromorphone, methadone, methadone intermediate, morphine (for 
sale), opium, oripavine, oxycodone (for sale), oxycodone (for 
conversion), oxymorphone (for sale), sufentanil, tetrahydrocannabinols, 
and thebaine, the DEA has determined that the proposed revised 2008 
aggregate production quotas are sufficient to meet the current 2008 
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 2008 final aggregate production quotas for the 
following controlled substances, expressed in grams of anhydrous acid 
or base, be established as follows:

------------------------------------------------------------------------
                                                          Final revised
                Basic class--Schedule I                    2008 quotas
                                                             (grams)
------------------------------------------------------------------------
2,5-Dimethoxyamphetamine..............................                 2
2,5-Dimethoxy-4-ethylamphetamine (DOET)...............                 2
2,5-Dimethoxy-4-(n)-propylthiophenethylamine (2C-T-7).                10
3-Methylfentanyl......................................                 2
3-Methylthiofentanyl..................................                 2

[[Page 66940]]

 
3,4-Methylenedioxyamphetamine (MDA)...................                20
3,4-Methylenedioxy-N-ethylamphetamine (MDEA)..........                10
3,4-Methylenedioxymethamphetamine (MDMA)..............                22
3,4,5-Trimethoxyamphetamine...........................                 2
4-Bromo-2,5-dimethoxyamphetamine (DOB)................                 2
4-Bromo-2,5-dimethoxyphenethylamine (2-CB)............                 7
4-Methoxyamphetamine..................................                77
4-Methylaminorex......................................                 2
4-Methyl-2,5-dimethoxyamphetamine (DOM)...............                12
5-Methoxy-3,4-methylenedioxyamphetamine...............                 2
5-Methoxy-N,N-diisopropyltryptamine...................                 5
Acetyl-alpha-methylfentanyl...........................                 2
Acetyldihydrocodeine..................................                 2
Acetylmethadol........................................                 2
Allylprodine..........................................                 2
Alphacetylmethadol....................................                 2
Alpha-ethyltryptamine.................................                 2
Alphameprodine........................................                 2
Alphamethadol.........................................                 3
Alpha-methylfentanyl..................................                 2
Alpha-methylthiofentanyl..............................                 2
Alpha-methyltryptamine................................                 5
Aminorex..............................................                 8
Benzylmorphine........................................                 2
Betacetylmethadol.....................................                 2
Beta-hydroxy-3-methylfentanyl.........................                 2
Beta-hydroxyfentanyl..................................                 2
Betameprodine.........................................                 2
Betamethadol..........................................                 2
Betaprodine...........................................                 2
Bufotenine............................................                 8
Cathinone.............................................                 3
Codeine-N-oxide.......................................               302
Diethyltryptamine.....................................                 2
Difenoxin.............................................                50
Dihydromorphine.......................................         2,549,000
Dimethyltryptamine....................................                 3
Gamma-hydroxybutyric acid.............................        21,940,000
Heroin................................................                20
Hydromorphinol........................................             3,000
Hydroxypethidine......................................                 2
Ibogaine..............................................                 1
Lysergic acid diethylamide (LSD)......................                61
Marihuana.............................................         4,500,000
Mescaline.............................................                 2
Methaqualone..........................................                10
Methcathinone.........................................                 4
Methyldihydromorphine.................................                 2
Morphine-N-oxide......................................               310
N,N-Dimethylamphetamine...............................                 7
N-Ethylamphetamine....................................                 2
N-Hydroxy-3,4-methylenedioxyamphetamine...............                 2
Noracymethadol........................................                 2
Norlevorphanol........................................                52
Normethadone..........................................                 2
Normorphine...........................................                16
Para-fluorofentanyl...................................                 2
Phenomorphan..........................................                 2
Pholcodine............................................                 2
Psilocybin............................................                 7
Psilocyn..............................................                 7
Tetrahydrocannabinols.................................           312,500
Thiofentanyl..........................................                 2
Trimeperidine.........................................                 2
------------------------------------------------------------------------


------------------------------------------------------------------------
                                                          Final revised
               Basic class--Schedule II                    2008 quotas
                                                             (grams)
------------------------------------------------------------------------
1-Phenylcyclohexylamine...............................                 2
Alfentanil............................................             8,000
Alphaprodine..........................................                 2

[[Page 66941]]

 
Amobarbital...........................................                 3
Amphetamine (for sale)................................        17,000,000
Amphetamine (for conversion)..........................         5,000,000
Cocaine...............................................           247,000
Codeine (for sale)....................................        39,605,000
Codeine (for conversion)..............................        71,000,000
Dextropropoxyphene....................................       106,000,000
Dihydrocodeine........................................         1,200,000
Diphenoxylate.........................................           761,000
Ecgonine..............................................            83,000
Ethylmorphine.........................................                 2
Fentanyl..............................................         1,428,000
Glutethimide..........................................                 2
Hydrocodone (for sale)................................        55,000,000
Hydrocodone (for conversion)..........................         1,500,000
Hydromorphone.........................................         3,300,000
Isomethadone..........................................                 2
Levo-alphacetylmethadol (LAAM)........................                 3
Levomethorphan........................................                 5
Levorphanol...........................................            10,000
Lisdexamfetamine......................................         6,200,000
Meperidine............................................         8,600,000
Metazocine............................................                 1
Methadone (for sale)..................................        25,000,000
Methadone Intermediate................................        26,000,000
Methamphetamine.......................................         3,130,000
------------------------------------------------------------------------
[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
Morphine (for sale)...................................        35,000,000
Morphine (for conversion).............................       110,000,000
Nabilone..............................................             5,502
Noroxymorphone (for sale).............................            10,000
Noroxymorphone (for conversion).......................         9,000,000
Opium.................................................         1,400,000
Oripavine.............................................        15,000,000
Oxycodone (for sale)..................................        70,000,000
Oxycodone (for conversion)............................         4,820,000
Oxymorphone (for sale)................................         2,000,000
Oxymorphone (for conversion)..........................        12,000,000
Pentobarbital.........................................        28,000,000
Phenazocine...........................................                 1
Phencyclidine.........................................             2,021
Phenmetrazine.........................................                 2
Phenylacetone.........................................                 1
Racemethorphan........................................                 2
Remifentanil..........................................               410
Secobarbital..........................................                 2
Sufentanil............................................            10,300
Thebaine..............................................       126,000,000
------------------------------------------------------------------------

    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 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

[[Page 66942]]

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 31, 2008.
Michele M. Leonhart,
Deputy Administrator.
[FR Doc. E8-26798 Filed 11-10-08; 8:45 am]
BILLING CODE 4410-09-P