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Federal
Register Notices > Quotas - 2009
> Final Revised Aggregate Production Quotas for 2009
FR Doc E9-25274[Federal Register: October 21, 2009 (Volume 74, Number
202)] [Notices] [Page 54077-54080] From the Federal Register Online via
GPO Access [wais.access.gpo.gov] [DOCID:fr21oc09-97]
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA-317F]
Controlled Substances: Final Revised Aggregate Production Quotas
for 2009
AGENCY: Drug Enforcement Administration (DEA), Justice.
ACTION: Notice of final aggregate production quotas for 2009.
SUMMARY: This notice establishes final 2009 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 2009 published July 23, 2009 (74 FR
36511).
DATES: Effective Date: October 21, 2009.
FOR FURTHER INFORMATION CONTACT: Christine A. Sannerud, Ph.D,
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 2009 aggregate production quotas represent those quantities of
controlled substances in schedules I and II that may be produced in the
United States in 2009 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 23, 2009, a notice of the proposed revised 2009 aggregate
production quotas for certain controlled substances in schedules I and
II was published in the Federal Register (74 FR 36511). All interested
persons were invited to comment on or object to these proposed aggregate
production quotas on or before August 24, 2009.
Seven companies commented on a total of 18 schedules I and II
controlled substances within the published comment period. Seven
companies proposed that the aggregate production quotas for amphetamine
(for sale), codeine (for conversion), dihydromorphine, fentanyl,
hydrocodone (for sale), hydromorphone, lisdexamfetamine, methadone,
methadone intermediate, methamphetamine (for sale), methylphenidate,
nabilone, opium (tincture), oxycodone (for sale), oxycodone (for
conversion), oxymorphone (for sale), phenylacetone, 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 2008 year-end inventories, initial 2009 manufacturing quotas,
2009 export requirements, actual and projected 2009 sales, research,
product development requirements, and additional applications received.
Based on this information, the DEA has adjusted the final 2009 aggregate
production quotas for amphetamine (for conversion), dihydromorphine,
hydrocodone (for sale), hydromorphone, lisdexamfetamine, morphine (for
sale), opium (tincture), oxycodone (for sale), oxycodone (for
conversion), oxymorphone (for sale), and phenylacetone to meet the
legitimate needs of the United States.
Regarding amphetamine (for sale), codeine (for conversion), fentanyl,
methadone, methadone intermediate, methamphetamine (for sale),
methylphenidate, nabilone, and thebaine, the DEA has determined that the
proposed revised 2009 aggregate production quotas are sufficient to meet
the current 2009 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. Sec. 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 2009 final
aggregate production quotas for the following controlled substances,
[[Page 54078]]
expressed in grams of anhydrous acid or base, be established as
follows:
| Basic class--Schedule I |
Final revised 2009 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 |
27 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 |
| 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 |
3,132,000 g |
| Dimethyltryptamine |
3 g |
| Gamma-hydroxybutyric acid |
24,200,00 g |
| Heroin |
20 g |
| Hydromorphinol |
2 g |
| Hydroxypethidine |
2 g |
| Ibogaine |
1 g |
| Lysergic acid diethylamide (LSD) |
10 g |
| Marihuana |
4,500,000 g |
| Mescaline |
7 g |
| Methaqualone |
5 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 54079]]
| Basic class--Schedule II |
Final revised 2009 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) |
7,500,000 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) |
55,500,000 g |
| Hydromorphone |
3,340,000 g |
| Isomethadone |
2 g |
| Levo-alphacetylmethadol (LAAM) |
3 g |
| Levomethorphan |
5 g |
| Levorphanol |
10,000 g |
| Lisdexamfetamine |
8,200,000 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 |
3,130,000 g |
| Methylphenidate |
50,000,000 g |
| Morphine (for sale) |
36,300,000 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) |
1,250,000 g |
| Oripavine |
15,000,000 g |
| Oxycodone (for sale) |
94,000,000 g |
| Oxycodone (for conversion) |
4,500,000 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 |
250,001 g |
| Racemethorphan |
2 g |
| Remifentanil |
500 g |
| Secobarbital |
67,000 g |
| Sufentanil |
10,300 g |
| Thebaine |
126,000,000 g |
DEA proposed the aggregate production quota for tapentadol at 519,000
g in the 2009 proposed revised aggregate production quota notice
published on July 23, 2009, in the Federal Register (74 FR 36511).
Tapentadol is no longer listed because the material will be imported
into the United States and not manufactured domestically.
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
[[Page 54080]]
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 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 13, 2009.
Michele M. Leonhart,
Deputy Administrator.
[FR Doc. E9-25274 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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