[Federal Register Volume 72, Number 164 (Friday, August 24, 2007)]
[Notices]
[Pages 48686-48689]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E7-16730]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. DEA-290F]


Controlled Substances: Final Revised Aggregate Production Quotas 
for 2007

AGENCY: Drug Enforcement Administration (DEA), Justice.

ACTION: Notice of final aggregate production quotas for 2007.

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SUMMARY: This notice establishes final 2007 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 2007 published May 3, 2007 (72 FR 24608).

EFFECTIVE DATE: August 24, 2007.

FOR FURTHER INFORMATION CONTACT: Christine A. Sannerud, PhD, Chief, 
Drug and 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 2007 aggregate production quotas represent those quantities of 
controlled substances in schedules I and II that may be produced in the 
United States in 2007 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 May 3, 2007, a notice of the proposed revised 2007 aggregate 
production quotas for certain controlled substances in schedules I and 
II was published in the Federal Register (72 FR 24608). All interested 
persons were invited to comment on or object to these proposed 
aggregate production quotas on or before May 24, 2007.
    Nine companies commented on a total of 31 schedules I and II 
controlled substances within the published comment period. Nine 
companies proposed that the aggregate production quotas for 14-
hydroxymorphinone, alfentanil, amphetamine (for sale), amphetamine (for 
conversion), cocaine, codeine (for conversion), dextropropoxyphene, 
dihydromorphine, diphenoxylate, ecgonine, fentanyl, gamma 
hydroxybutyric acid, hydrocodone, hydromorphone, lisdexamfetamine, 
meperidine, methadone, methadone intermediate, methylphenidate, 
morphine, morphine (for conversion), nabilone, noroxymorphone (for 
conversion), oxycodone, oxymorphone, oxymorphone (for conversion), 
pentobarbital, remifentanil, 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.
    The DEA has determined that the compound 14-hydroxymorphinone is a 
morphine derivative. The comment received concerning this substance was 
therefore, considered as a comment for morphine.
    DEA has taken into consideration the above comments along with the 
relevant 2006 year-end inventories, initial 2007 manufacturing quotas, 
2007 export requirements, actual and projected 2007 sales, research, 
product development requirements and additional applications received. 
Based on this information, the DEA has adjusted the final 2007 
aggregate production quotas for 2,5-dimethoxyamphetamine, alfentanil, 
amphetamine (for conversion), gamma-hydroxybutyric acid, hydrocodone, 
methylphenidate, oxycodone, oxycodone (for conversion), pentobarbital, 
remifentanil, sufentanil and thebaine to meet the legitimate needs of 
the United States.
    Regarding amphetamine (for sale), cocaine, codeine (for 
conversion), dextropropoxyphene, dihydromorphine, diphenoxylate, 
ecgonine, fentanyl, hydromorphone, lisdexamfetamine, meperidine, 
methadone, methadone intermediate, morphine, morphine (for conversion), 
nabilone, noroxymorphone (for conversion), oxymorphone, oxymorphone 
(for conversion), and tetrahydrocannabinols the DEA has determined that 
the proposed revised 2007 aggregate production quotas are sufficient to 
meet the current 2007 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 2007 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                    2007 quotas
                                                             (grams)
------------------------------------------------------------------------
2,5-Dimethoxyamphetamine..............................                 2
2,5-Dimethoxy-4-ethylamphetamine (DOET)...............                 2
2,5-Dimethoxy-4-(n)-propylthiophenethylamine (2C-T-7).                10

[[Page 48687]]

 
3-Methylfentanyl......................................                 2
3-Methylthiofentanyl..................................                 2
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.............................        23,600,000
Heroin................................................                 5
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                    2007 quotas
                                                              (grams)
------------------------------------------------------------------------
1-Phenylcyclohexylamine.................................               2

[[Page 48688]]

 
Alfentanil..............................................           5,200
Alphaprodine............................................               2
Amobarbital.............................................               3
Amphetamine (for sale)..................................      17,000,000
Amphetamine (for conversion)............................       5,000,000
Cocaine.................................................         286,000
Codeine (for sale)......................................      39,605,000
Codeine (for conversion)................................      59,000,000
Dextropropoxyphene......................................     120,000,000
Dihydrocodeine..........................................       2,435,000
Diphenoxylate...........................................         828,000
Ecgonine................................................          83,000
Ethylmorphine...........................................               2
Fentanyl................................................       1,428,000
Glutethimide............................................               2
Hydrocodone (for sale)..................................      46,000,000
Hydrocodone (for conversion)............................       1,500,000
Hydromorphone...........................................       3,300,000
Isomethadone............................................               2
Levo-alphacetylmethadol (LAAM)..........................               6
Levomethorphan..........................................               5
Levorphanol.............................................           6,000
Lisdexamfetamine........................................       6,200,000
Meperidine..............................................       9,753,000
Metazocine..............................................               1
Methadone (for sale)....................................      25,000,000
Methadone Intermediate..................................      26,000,000
Methamphetamine.........................................       3,130,000
Methylphenidate.........................................      50,000,000
Morphine (for sale).....................................      35,000,000
Morphine (for conversion)...............................     110,774,000
Nabilone................................................           3,002
Noroxymorphone (for sale)...............................           1,002
Noroxymorphone (for conversion).........................      11,000,000
Opium...................................................       1,400,000
Oxycodone (for sale)....................................      70,000,000
Oxycodone (for conversion)..............................       3,100,000
Oxymorphone.............................................       1,800,000
Oxymorphone (for conversion)............................      15,300,000
Pentobarbital...........................................      35,200,000
Phencyclidine...........................................           2,021
Phenmetrazine...........................................               2
Racemethorphan..........................................               2
Remifentanil............................................           3,000
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 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

[[Page 48689]]

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: August 15, 2007.
Michele M. Leonhart,
Deputy Administrator.
 [FR Doc. E7-16730 Filed 8-23-07; 8:45 am]
BILLING CODE 4410-09-P