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Notice of final aggregate production quotas for 2006
FR Doc E6-17524 [Federal Register: October 19, 2006 (Volume 71, Number 202)]
[Notices] [Page 61803-61806] From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr19oc06-129]
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA-270F]
Controlled Substances: Final Revised Aggregate Production Quotas for 2006
AGENCY: Drug Enforcement Administration (DEA), U.S. Department of
Justice.
ACTION: Notice of final aggregate production quotas for 2006.
SUMMARY: This notice establishes final 2006 aggregate production quotas for
controlled substances in Schedules I and II of the Controlled Substances Act of
1970 (CSA). The DEA has taken into consideration comments received in response
to a notice of the proposed revised aggregate production quotas for 2006
published July 5, 2006 (71 FR 38174).
EFFECTIVE DATE: October 19, 2006.
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 (Title 21 United States
Code (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 2006 aggregate production quotas represent those quantities of
controlled substances in Schedules I and II that may be produced in the United
States in 2006 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 5, 2006, a notice of the proposed revised 2006
aggregate production quotas for certain controlled substances in Schedules I and
II was published in the Federal Register (71 FR 38174). All interested persons
were invited to comment on or object to these proposed aggregate production
quotas on or before July 26, 2006.
Eight companies commented on a total of 22
Schedules I and II controlled substances within the published comment period.
Eight companies proposed that the aggregate production quotas for alfentanil,
amphetamine, codeine (for conversion), dihydrocodeine, dihydromorphine,
diphenoxylate, fentanyl, gamma hydroxybutyric acid, hydrocodone, hydromorphinol,
hydromorphone, methadone, methylphenidate, morphine (for conversion),
N,N-dimethylamphetamine, opium, oxycodone, oxycodone (for conversion),
oxymorphone, oxymorphone (for conversion), 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 2005 year-end
inventories, initial 2006 manufacturing quotas, 2006 export requirements, actual
and projected 2006 sales, research, product development requirements and
additional applications received. Based on this information, the DEA has
adjusted the final 2006 aggregate production quotas for alfentanil, codeine (for
conversion), dextropropoxyphene, dihydromorphine, hydrocodone, hydromorphone,
morphine (for conversion), N,N-dimethylamphetamine, opium, oxycodone, oxycodone
(for conversion), oxymorphone, oxymorphone (for conversion),
tetrahydrocannabinols, and thebaine to meet the legitimate needs of the United
States.
Regarding amphetamine, dihydrocodeine, diphenoxylate, fentanyl, gamma
hydroxybutyric acid, hydromorphinol, methadone, and methylphenidate, the DEA has
determined that the proposed revised 2006 aggregate production quotas are
sufficient to meet the current 2006 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 2006 final aggregate production
quotas for the following controlled substances, expressed in grams of anhydrous
acid or base, be established as follows:
[[Page 61804]]
Basic class--schedule I |
Final revised 2006 quotas |
2,5-Dimethoxyamphetamine |
2,801,000 g |
2,5-Dimethoxy-4-ethylamphetamine (DOET) |
2 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) |
2 g |
4-Methoxyamphetamine |
77 g |
g 4-Methylaminorex |
2 g |
4-Methyl-2,5-dimethoxyamphetamine (DOM) |
12 g |
5-Methoxy-3,4-methylenedioxyamphetamine |
2 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 |
Aminorex |
2 g |
Benzylmorphine |
2 g |
Beta-hydroxy-3-methylfentanyl |
2 g |
Beta-hydroxyfentanyl |
2 g |
Betameprodine |
2 g |
Betamethadol |
2 g |
Betaprodine |
2 g |
Bufotenine |
5 g |
Cathinone |
3 g |
Codeine-N-oxide |
302 g |
Diethyltryptamine |
2 g |
Difenoxin |
5,000 g |
Dihydromorphine |
2,449,000 g |
Dimethyltryptamine |
3 g |
Gamma-hydroxybutyric acid |
8,000,000 g |
Heroin |
5 g |
Hydromorphinol |
2 g |
Hydroxypethidine |
2 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 |
338,000 g |
Thiofentanyl |
2 g |
Trimeperidine |
2 g |
Basic class--schedule II |
Final revised 2006 quotas |
1-Phenylcyclohexylamine |
2 g |
Alfentanil |
7,200 g |
Alphaprodine |
2 g |
Amobarbital |
101,000 g |
Amphetamine |
17,000,000 g |
Cocaine |
286,000 g |
Codeine (for sale) |
39,605,000 g |
Codeine (for conversion) |
120,000,000 g |
Dihydrocodeine |
1,261,000 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 |
2,500,000 g |
Isomethadone |
2 g |
Levo-alphacetylmethadol (LAAM) |
6 g |
Levomethorphan |
5 g |
Levorphanol |
5,000 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) |
100,000,000 |
Nabilone |
2 g
|
Noroxymorphone (for sale) |
1,002 g |
Noroxymorphone (for conversion) |
5,600,000 g |
Opium |
1,360,000 g |
Oxycodone (for sale) |
56,000,000 g |
Oxycodone (for conversion) |
4,610,000 g |
Oxymorphone
|
806,000 g
|
Oxymorphone (for conversion) |
2,400,000 g |
Pentobarbital |
28,000,000 g |
Phencyclidine |
2,021 g |
Phenmetrazine |
2 g |
Racemethorphan |
2 g |
Remifentanil |
2,700 g |
Secobarbital |
2 g |
Sufentanil |
6,500 g |
Thebaine |
78,000,000 g
|
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 (E.O.) 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 E.O. 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 E.O. 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
[[Page 61806]]
ability of United States-based companies to compete with foreign-based
companies in domestic and export markets.
Dated: October 13, 2006.
Michele M. Leonhart, Deputy Administrator.
[FR
Doc. E6-17524 Filed 10-18-06; 8:45 am]
BILLING CODE 4410-09-P
NOTICE: This is an
unofficial version. An official version of these publications may be obtained
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