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Federal
Register Notices > Quotas - 2009
> Established Initial Aggregate Production Quotas for
2010
FR Doc E9-25275[Federal Register: October 21, 2009 (Volume 74, Number
202)] [Notices] [Page 54080-54083] From the Federal Register Online via
GPO Access [wais.access.gpo.gov] [DOCID:fr21oc09-98]
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[DEA 318E]
Controlled Substances: Established Initial Aggregate Production
Quotas for 2010
AGENCY: Drug Enforcement Administration (DEA), Justice.
ACTION: Notice of aggregate production quotas for 2010.
SUMMARY: This notice establishes initial 2010 aggregate
production quotas for controlled substances in schedules I and II of the
Controlled Substances Act (CSA).
DATES: Effective Date: October 21, 2009.
FOR FURTHER INFORMATION CONTACT: Christine A. Sannerud, Ph.D,
Chief, Drug & 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 2010 aggregate production quotas represent those quantities of
controlled substances 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 for use in industrial processes.
On May 21, 2009, a notice of the proposed initial 2010 aggregate
production quotas for certain controlled substances in schedules I and
II was published in the Federal Register (74 FR 23881). All interested
persons were invited to comment on or object to these proposed aggregate
production quotas on or before June 22, 2009.
Twelve responses (eleven from DEA registered manufacturers, and one
from a non-DEA registrant) were received within the published comment
period, offering comments on a total of 28 schedule I and II controlled
substances. One additional comment was received after the comment period
ended and therefore was not considered. The commenters stated that the
proposed aggregate production quotas for 3,4- methylenedioxyamphetamine,
3,4-methylenedioxyethylamphetamine, 3,4- methylenedioxymethamphetamine,
alfentanil, amphetamine (for sale), codeine (for sale), codeine (for
conversion), dihydromorphine, fentanyl, gamma hydroxybutyric acid,
hydrocodone, hydromorphone, isomethadone, levo-desoxyephedrine,
levorphanol, lisdexamfetamine, methamphetamine (for sale), morphine (for
conversion), nabilone, opium (tincture), oxycodone (for sale), oxycodone
(for conversion), oxymorphone (for sale), remifentanil, sufentanil,
tapentadol, 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.
In arriving at the aggregate production quotas, DEA has taken into
consideration the above comments along with the factors set forth at 21
CFR 1303.11(b) and other relevant 2009 factors, including 2009
manufacturing quotas, current 2009 sales and inventories, 2010 export
requirements, additional applications received, and research and product
development requirements. Based on this information, DEA has adjusted
the initial aggregate production quotas for 4- methoxyamphetamine,
alpha-methyltryptamine, amphetamine (for conversion), dihydromorphine,
isomethadone, levo-desoxyephedrine, lisdexamfetamine, lysergic acid
diethylamide, methamphetamine (for sale), methamphetamine (for
conversion), methaqualone, oxycodone (for sale), oxycodone (for
conversion), oxymorphone (for sale) and phenylacetone to meet the
legitimate needs of the United States.
DEA proposed the aggregate production quota for tapentadol at 519,000
g in the 2010 proposed initial aggregate production quota notice
published on May 21, 2009 in the Federal Register (74 FR 23881).
Tapentadol is no longer listed because the material will be imported
into the United States and not manufactured domestically.
Regarding 3,4-methylenedioxyamphetamine, 3,4-
methylenedioxyethylamphetamine, 3,4-methylenedioxymethamphetamine,
alfentanil, amphetamine (for sale), codeine (for sale), codeine (for
conversion), fentanyl, gamma hydroxybutyric acid, hydrocodone,
hydromorphone, levorphanol, morphine (for conversion), nabilone, opium
(tincture), remifentanil, sufentanil, tetrahydrocannabinols, and
thebaine DEA has determined that the proposed initial 2010 aggregate
production quotas are sufficient to meet the current 2010 estimated
medical, scientific, research and industrial needs of the United States.
Pursuant to 21 CFR 1303, the Deputy Administrator of DEA will, in
2010, adjust aggregate production quotas and individual manufacturing
quotas allocated for the year based upon 2009 year-end inventory and
actual 2009 disposition data supplied by quota recipients for each basic
class of schedule I or II controlled substance.
[[Page 54081]]
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 DEA by 28 CFR
Sec. 0.100, and redelegated to the Deputy Administrator pursuant to 28
CFR 0.104, the Deputy Administrator hereby orders that the 2010 initial
aggregate production quotas for the following controlled substances,
expressed in grams of anhydrous acid or base, be established as follows:
| Basic class--Schedule I |
Established 2010 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 (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 |
| 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 |
| Alpha-methyltryptamine |
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 |
3,300,000 g |
| Dimethyltryptamine |
3 g |
| Gamma-hydroxybutyric acid |
24,200,000 g |
| Heroin |
20 g |
| Hydromorphinol |
2 g |
| Hydroxypethidine |
2 g |
| Ibogaine |
1 g |
| Lysergic acid diethylamide (LSD) |
15 g |
| Marihuana |
4,500,000 g |
| Mescaline |
7 g |
| Methaqualone |
7 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 54082]]
| Basic class--Schedule II |
Established 2010 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) |
6,500,000 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) |
55,000,000 g |
| Hydromorphone |
3,300,000 g |
| Isomethadone |
11 g |
| Levo-alphacetylmethadol (LAAM) |
3 g |
| Levomethorphan |
5 g |
| Levorphanol |
10,000 g |
| Lisdexamfetamine |
9,000,000 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
[750,000 grams of levo-desoxyephedrine for use in a
non-controlled, non-prescription product; 2,331,000 grams for
methamphetamine mostly for conversion to a schedule III product;
and 49,000 grams for methamphetamine (for sale)] |
3,130,000 g |
| Methylphenidate |
50,000,000 g |
| Morphine (for sale) |
35,000,000 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) |
1,050,000 g |
| Oripavine |
15,000,000 g |
| Oxycodone (for sale) |
88,000,000 g |
| Oxycodone (for conversion) |
4,000,000 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 |
12,500,001 g |
| Racemethorphan |
2 g |
| Remifentanil |
500 g |
| Secobarbital |
67,000 g |
| Sufentanil |
10,300 g |
| Thebaine |
126,000,000 g |
The Deputy Administrator further orders that aggregate production
quotas for all other schedules I and II controlled substances included
in 21 CFR 1308.11 and 1308.12 be established at 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
[[Page 54083]]
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 14, 2009.
Michele M. Leonhart,
Deputy Administrator.
[FR Doc. E9-25275 Filed 10-20-09; 8:45 am]
BILLING CODE 4410-09-P
NOTICE: This is an
unofficial version. An official version of these publications may be obtained
directly from the Government Printing Office (GPO).
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