Federal
Register Notices > Quotas - 2006
> Established Initial Aggregate Production Quotas for
2007
FR Doc E6-20920 [Federal Register: December 11, 2006 (Volume 71, Number 237)]
[Notices] [Page 71559-71562] From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr11de06-62]
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[DEA 290E]
Controlled Substances: Established Initial Aggregate Production Quotas for
2007
AGENCY: Drug Enforcement Administration (DEA), Justice.
ACTION: Notice of aggregate production quotas for 2007.
SUMMARY: This notice establishes initial 2007 aggregate production quotas for
controlled substances in schedules I and II of the Controlled Substances Act
(CSA).
DATES: Effective Date: December 11, 2006.
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 Title 21 United States Code
section 826 (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 Code of Federal Regulations (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 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 for use
in industrial processes.
On August 29, 2006, a notice of the proposed initial 2007 aggregate
production quotas for certain controlled substances in schedules I and II was
published in the Federal Register (71 FR 51214). All interested persons were
invited to comment on or object to these proposed aggregate production quotas on
or before September 19, 2006.
Five responses were received within the published comment period resulting in
comments on a total of 25 schedule I and II controlled substances. The responses
commented that the proposed aggregate production quotas for alfentanil, aminorex,
cocaine, codeine (for conversion), dihydrocodeine, ecgonine, fentanyl,
hydrocodone, hydromorphone, levorphanol, methadone, methadone intermediate,
methamphetamine, methylphenidate, morphine (for conversion), nabilone,
noroxymorphone (for conversion), oxycodone, oxycodone (for conversion),
oxymorphone, oxymorphone (for conversion), 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.
DEA has taken into consideration the above comments along with the relevant
2006 manufacturing quotas, current 2006 sales and inventories, 2007 export
requirements, additional applications received, and research and product
development requirements. Based on this information, the DEA has adjusted the
initial aggregate production quotas for alfentanil, aminorex, amobarbital,
codeine (for conversion), dextropropoxyphene, dihydrocodeine, gamma
hydroxybutyric acid, ibogaine, hydrocodone, metazocine, nabilone, noroxymorphone
(for conversion), oxycodone, oxycodone (for conversion), oxymorphone,
oxymorphone (for conversion), remifentanil, sufentanil,
[[Page 71560]]
and thebaine to meet the legitimate needs of the United States.
Regarding cocaine, ecgonine, fentanyl, hydromorphone, levorphanol, methadone,
methadone intermediate, methamphetamine, methylphenidate, morphine (for
conversion) and tetrahydrocannabinols, the DEA has determined that the proposed
initial 2007 aggregate production quotas are sufficient to meet the current 2007
estimated medical, scientific, research and industrial needs of the United
States.
Pursuant to 21 CFR Part 1303, the Deputy Administrator of the DEA will, in
2007, adjust aggregate production quotas and individual manufacturing quotas
allocated for the year based upon 2006 year-end inventory and actual 2006
disposition data supplied by quota recipients for each basic class of schedule I
or II controlled substance.
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 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 initial 2007 quotas |
2,5-Dimethoxyamphetamine
|
2,001,000 g
|
2,5-Dimethoxy-4-ethylamphetamine (DOET)
|
2 g
|
2,5-Dimethoxy-4-(n)-propylthiophenethylamine (2C-T-7)
|
10 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)
|
22 g
|
3,4,5-Trimethoxyamphetamine
|
2 g
|
4-Bromo-2,5-dimethoxyamphetamine (DOB)
|
2 g
|
4-Bromo-2,5-dimethoxyphenethylamine (2-CB)
|
7 g
|
4-Methoxyamphetamine
|
77 g
|
4-Methylaminorex
|
2 g
|
4-Methyl-2,5-dimethoxyamphetamine (DOM)
|
12 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
|
3 g
|
Alpha-methylfentanyl
|
2 g
|
Alpha-methylthiofentanyl
|
2 g
|
Alpha-methyltryptamine
|
5 g
|
Aminorex
|
8 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
|
8 g
|
Cathinone
|
3 g
|
Codeine-N-oxide
|
302 g
|
Diethyltryptamine
|
2 g
|
Difenoxin
|
50 g
|
Dihydromorphine
|
2,549,000 g
|
Dimethyltryptamine
|
3 g
|
Gamma-hydroxybutyric acid
|
13,100,000 g
|
Heroin
|
5 g
|
Hydromorphinol
|
3,000 g
|
Hydroxypethidine
|
2 g
|
Ibogaine
|
1 g
|
Lysergic acid diethylamide (LSD)
|
61 g
|
Marihuana
|
4,500,000 g
|
Mescaline
|
2 g
|
Methaqualone
|
10 g
|
Methcathinone
|
4 g
|
Methyldihydromorphine
|
2 g
|
Morphine-N-oxide
|
310 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
|
Basic Class--Schedule II
|
Established initial 2007 quotas |
1-Phenylcyclohexylamine
|
2 g
|
Alfentanil
|
7,200 g
|
Alphaprodine
|
2 g
|
Amobarbital
|
3 g
|
Amphetamine
|
17,000,000 g
|
Cocaine
|
286,000 g
|
Codeine (for sale)
|
39,605,000 g
|
Codeine (for conversion)
|
59,000,000 g
|
Dextropropoxyphene
|
120,000,000 g
|
Dihydrocodeine
|
2,435,000 g
|
Diphenoxylate
|
828,000 g
|
Ecgonine
|
83,000 g
|
Ethylmorphine
|
2 g
|
Fentanyl
|
1,428,000 g
|
Glutethimide
|
2 g
|
Hydrocodone (for sale)
|
42,000,000 g
|
Hydrocodone (for conversion)
|
1,500,000 g
|
Hydromorphone
|
3,300,000 g
|
Isomethadone
|
2 g
|
Levo-alphacetylmethadol (LAAM)
|
6 g
|
Levomethorphan
|
5 g
|
Levorphanol
|
6,000 g
|
Meperidine
|
9,753,000 g
|
Metazocine
|
1 g
|
Methadone (for sale)
|
25,000,000 g
|
Methadone Intermediate
|
26,000,000 g
|
Methamphetamine 680,000 grams of levo-desoxyephedrine for use in
a non-controlled, non-prescription product; 2,405,000 grams for
methamphetamine mostly for conversion to a schedule III product;
and 45,000 grams for methamphetamine (for sale)]
|
3,130,000 g
|
Methylphenidate
|
35,000,000 g
|
Morphine (for sale)
|
35,000,000 g
|
Morphine (for conversion)
|
110,774,000 g
|
Nabilone
|
3,002 g
|
Noroxymorphone (for sale)
|
1,002 g
|
Noroxymorphone (for conversion)
|
11,000,000 g
|
Opium
|
1,400,000 g
|
Oxycodone (for sale)
|
56,000,000 g
|
Oxycodone (for conversion)
|
25,000,000 g
|
Oxymorphone
|
1,800,000 g
|
Oxymorphone (for conversion)
|
15,300,000 g
|
Pentobarbital
|
28,000,000 g
|
Phencyclidine
|
2,021 g
|
Phenmetrazine
|
2 g
|
Racemethorphan
|
2 g
|
Remifentanil
|
5,000 g
|
Secobarbital
|
2 g
|
Sufentanil
|
12,300 g
|
Thebaine
|
102,000,000 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
[[Page 71562]]
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 $118,000,000 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: December 1, 2006.
Michele M. Leonhart,
Deputy Administrator.
[FR Doc. E6-20920 Filed 12-8-06; 8:45 am]
BILLING CODE 4410-09-P
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