[Federal Register: August 24, 2007 (Volume 72, Number 164)]
[Notices]
[Page 48686-48689]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr24au07-114]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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