[Federal Register Volume 75, Number 177 (Tuesday, September 14, 2010)]
[Notices]
[Pages 55828-55831]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-22785]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. DEA-318F]


Controlled Substances: Final Revised Aggregate Production Quotas 
for 2010

AGENCY: Drug Enforcement Administration (DEA), Justice.

ACTION: Notice of final aggregate production quotas for 2010.

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SUMMARY: This notice establishes final 2010 aggregate production quotas 
for controlled substances in schedules I and II of the Controlled 
Substances Act (CSA). DEA has taken into consideration comments 
received in response to a notice of the proposed revised aggregate 
production quotas for 2010 published June 23, 2010 (75 FR 35838).

DATES: Effective Date: September 14, 2010.

FOR FURTHER INFORMATION CONTACT: Christine A. Sannerud, Ph.D., Chief, 
Drug and Chemical Evaluation Section, Drug Enforcement Administration, 
8701 Morrissette Drive, Springfield, VA 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 2010 aggregate production quotas represent those quantities of 
controlled substances in schedules I and II 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.
    On June 23, 2010, a notice of the proposed revised 2010 aggregate 
production quotas for certain controlled substances in schedules I and 
II was published in the Federal Register (75 FR 35838). All interested 
persons were invited to comment on or object to these proposed 
aggregate production quotas on or before July 23, 2010.
    Fourteen companies, thirteen DEA registered manufacturers and one 
non-registrant, commented on a total of 28 schedules I and II 
controlled substances within the published comment period. Comments 
received proposed that the aggregate production quotas for alfentanil, 
amphetamine (for conversion), amphetamine (for sale), codeine (for 
conversion), codeine (for sale), dextropropoxyphene, dihydromorphine, 
diphenoxylate, gamma hydroxybutyric acid, hydrocodone, hydromorphone, 
lisdexamfetamine, meperidine, methadone, methylphenidate, morphine (for 
conversion), morphine (for sale), nabilone, opium (tincture), oxycodone 
(for conversion), oxycodone (for sale), oxymorphone (for sale), 
remifentanil, sufentanil, tapentadol, tetrahydrocannabinols, thebaine 
and tilidine 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 2009 year-end inventories, initial 2010 manufacturing quotas, 
2010 export requirements, actual and projected 2010 sales, research, 
product development requirements and additional applications received. 
Based on this information, the DEA has adjusted the final 2010 
aggregate production quotas for alfentanil, amphetamine (for 
conversion), amphetamine (for sale), carfentanil, dihydromorphine, 
diphenoxylate, marihuana, morphine (for sale), noroxymorphone (for 
sale), opium (tincture), oxycodone (for conversion), oxycodone (for 
sale), oxymorphone (for conversion), oxymorphone (for sale), 
tapentadol, tetrahydrocannabinols, and tilidine.
    4-anilino-N-phenethyl-4-piperidine (ANPP) pursuant to DEA's final 
rule published in the Federal Register on June 29, 2010 (75 FR 37295) 
will be controlled as a schedule II controlled substance on August 30, 
2010. As such, DEA has established an aggregate production quota for 
ANPP to meet the estimated medical, scientific, research, and 
industrial needs of the United States; lawful export requirements; and 
the establishment and maintenance of reserve stocks.
    Regarding codeine (for conversion), codeine (for sale), 
dextropropoxyphene, gamma hydroxybutyric acid, hydrocodone, 
hydromorphone, lisdexamfetamine, meperidine, methadone, 
methylphenidate, morphine (for conversion), nabilone, remifentanil, 
sufentanil, and thebaine, DEA has determined that the proposed revised 
2010 aggregate production quotas are sufficient to meet the current 
2010 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

[[Page 55829]]

Administrator hereby orders that the 2010 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                          2010 quotas
------------------------------------------------------------------------
                               Schedule I
------------------------------------------------------------------------
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)..................               20 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.................................               77 g
4-Methylaminorex.....................................                2 g
4-Methyl-2,5-dimethoxyamphetamine (DOM)..............                2 g
5-Methoxy-3,4-methylenedioxyamphetamine..............                2 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 (AMT).........................                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......................................        3,608,000 g
Dimethyltryptamine...................................                3 g
Gamma-hydroxybutyric acid............................       52,156,000 g
Heroin...............................................               20 g
Hydromorphinol.......................................                2 g
Hydroxypethidine.....................................                2 g
Ibogaine.............................................                1 g
Lysergic acid diethylamide (LSD).....................               15 g
Marihuana............................................           21,000 g
Mescaline............................................                5 g
Methaqualone.........................................                7 g
Methcathinone........................................                4 g
Methyldihydromorphine................................                2 g
Morphine-N-oxide.....................................              605 g
N-Benzylpiperazine...................................                2 g
N,N-Dimethylamphetamine..............................                2 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...........................................                2 g
Psilocyn.............................................                2 g
Tetrahydrocannabinols................................          264,000 g
Thiofentanyl.........................................                2 g

[[Page 55830]]

 
Tilidine.............................................               10 g
Trimeperidine........................................                2 g
------------------------------------------------------------------------
                               Schedule II
------------------------------------------------------------------------
1-Phenylcyclohexylamine..............................                2 g
4-anilino-N-phenethyl-4-piperidine (ANPP)............        1,100,000 g
Alfentanil...........................................            8,000 g
Alphaprodine.........................................                2 g
Amobarbital..........................................                3 g
Amphetamine (for conversion).........................        7,500,000 g
Amphetamine (for sale)...............................       18,600,000 g
Carfentanil..........................................              200 g
Cocaine..............................................          247,000 g
Codeine (for conversion).............................       65,000,000 g
Codeine (for sale)...................................       39,605,000 g
Dextropropoxyphene...................................       92,000,000 g
Dihydrocodeine.......................................          800,000 g
Diphenoxylate........................................          827,000 g
Ecgonine.............................................           83,000 g
Ethylmorphine........................................                2 g
Fentanyl.............................................        1,428,000 g
Glutethimide.........................................                2 g
Hydrocodone..........................................       55,000,000 g
Hydromorphone........................................        3,455,000 g
Isomethadone.........................................               11 g
Levo-alphacetylmethadol (LAAM).......................                3 g
Levomethorphan.......................................                5 g
Levorphanol..........................................           10,000 g
Lisdexamfetamine.....................................        9,000,000 g
Meperidine...........................................        6,600,000 g
Meperidine Intermediate-A............................                3 g
Meperidine Intermediate-B............................                7 g
Meperidine Intermediate-C............................                3 g
Metazocine...........................................                1 g
Methadone............................................       20,000,000 g
Methadone Intermediate...............................       26,000,000 g
Methamphetamine......................................        3,130,000 g
------------------------------------------------------------------------
750,000 g of levo-desoxyephedrine for use in a non-controlled, non-
 prescription product; 2,331,000 g for methamphetamine (for conversion)
 mostly for conversion to a schedule III product; and 49,000 g for
 methamphetamine (for sale)
------------------------------------------------------------------------
Methylphenidate......................................       50,000,000 g
Morphine (for conversion)............................       83,000,000 g
Morphine (for sale)..................................       39,000,000 g
Nabilone.............................................            9,002 g
Noroxymorphone (for conversion)......................        9,000,000 g
Noroxymorphone (for sale)............................           41,000 g
Opium (powder).......................................          230,000 g
Opium (tincture).....................................        1,500,000 g
Oripavine............................................       15,000,000 g
Oxycodone (for conversion)...........................        5,600,000 g
Oxycodone (for sale).................................      105,500,000 g
Oxymorphone (for conversion).........................       12,800,000 g
Oxymorphone (for sale)...............................        3,070,000 g
Pentobarbital........................................       28,000,000 g
Phenazocine..........................................                1 g
Phencyclidine........................................               14 g
Phenmetrazine........................................                2 g
Phenylacetone........................................       12,500,001 g
Racemethorphan.......................................                2 g
Remifentanil.........................................            2,500 g
Secobarbital.........................................           67,000 g
Sufentanil...........................................            7,000 g
Tapentadol...........................................        1,000,000 g
Thebaine.............................................      126,000,000 g
------------------------------------------------------------------------

    The Deputy Administrator further orders that the aggregate 
production quotas for all other schedule 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

[[Page 55831]]

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 
$126,400,000 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: September 2, 2010.
Michele M. Leonhart,
Deputy Administrator.
[FR Doc. 2010-22785 Filed 9-13-10; 8:45 am]
BILLING CODE 4410-09-P