Quotas - 2010
[Federal Register: December 20, 2010 (Volume 75, Number 243)]
[Notices]
[Page 79404-79407]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr20de10-961]
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[DEA 343E]
Controlled Substances: Established Initial Aggregate Production
Quotas for 2011
AGENCY: Drug Enforcement Administration (DEA), Justice.
ACTION: Notice of aggregate production quotas for 2011.
SUMMARY: This notice establishes initial 2011 aggregate production
quotas for controlled substances in schedules I and II of the
Controlled Substances Act (CSA).
DATES: Effective Date: December 20, 2010.
FOR FURTHER INFORMATION CONTACT: Christine A. Sannerud, PhD, Chief,
Drug & Chemical Evaluation Section, Drug Enforcement Administration,
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 to 28 CFR 0.104.
The 2011 aggregate production quotas represent those quantities of
controlled substances that may be produced in the United States in 2011
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 September 15, 2010, a notice of the proposed initial 2011
aggregate production quotas for certain controlled substances in
schedules I and II was published in the Federal Register (75 FR 56137).
All interested persons were invited to comment on or object to these
proposed aggregate production quotas on or before October 15, 2010.
Seven responses (six from DEA registered manufacturers, and one
from a non-DEA registrant) were received within the published comment
period, offering comments on a total of 31 schedules I and II
controlled substances. The commenters stated that the proposed
aggregate production quotas for 3,4-methylenedioxyamphetamine, 3,4-methylenedioxy-N-ethylamphetamine, 3,4-methylenedioxymethamphetamine,
4-anilino-N-phenethyl-4-piperidine, amphetamine (for sale), cathinone,
codeine (for sale), dihydromorphine, fentanyl, gamma hydroxybutyric
acid, heroin, hydrocodone, hydromorphone, marihuana, meperidine,
methaqualone, methylphenidate, morphine (for conversion), morphine (for
sale), nabilone, noroxymorphone (for conversion), opium (tincture),
oxycodone (for sale), pentobarbital, phencyclidine, remifentanil,
secobarbital, tapentadol, tetrahydrocannabinols, thebaine and tilidine
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 2010 factors, including 2010
manufacturing quotas, current 2010 sales and inventories, 2011 export
requirements, additional applications received, as well as research and
product development requirements. Based on this information, DEA has
adjusted the initial aggregate production quotas for 3,4-methylenedioxyamphetamine, 3,4-methylenedioxy-N-ethylamphetamine, 3,4-methylenedioxymethamphetamine, amobarbital, cathinone,
dimethyltryptamine, ibogaine, lysergic
[[Page 79405]]
acid diethylamide, metazocine, methaqualone, nabilone, normorphine,
noroxymorphone (for sale), phenazocine, phencyclidine, secobarbital,
and tetrahydrocannabinols to meet the legitimate needs of the United
States.
Regarding 4-anilino-N-phenethyl-4-piperidine, amphetamine (for
sale), codeine (for sale), dihydromorphine, fentanyl, gamma
hydroxybutyric acid, heroin, hydrocodone, hydromorphone, marihuana,
meperidine, methylphenidate, morphine (for conversion), morphine (for
sale), noroxymorphone (for conversion), opium (tincture), oxycodone
(for sale), pentobarbital, remifentanil, tapentadol, thebaine and
tilidine DEA has determined that the proposed initial 2011 aggregate
production quotas are sufficient to meet the current 2011 estimated
medical, scientific, research, and industrial needs of the United
States.
Pursuant to 21 CFR 1303, the Deputy Administrator of DEA will, in
2011, adjust aggregate production quotas and individual manufacturing
quotas allocated for the year based upon 2010 year-end inventory and
actual 2010 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 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 2011 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 2011 quotas |
| 1-Methyl-4-phenyl-4-propionoxypiperidine |
2 g |
| 2,5-Dimethoxyamphetamine |
2 g |
| 2,5-Dimethoxy-4-ethylamphetamine (DOET) |
2 g |
| 2,5-Dimethoxy-4-n-propylthiophenethylamine |
2 g |
| 3-Methylfentanyl |
2 g |
| 3-Methylthiofentanyl |
2 g |
| 3,4-Methylenedioxyamphetamine (MDA) |
22 g |
| 3,4-Methylenedioxy-N-ethylamphetamine (MDEA) |
15 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 |
| 4-Methylaminorex |
2 g |
| 4-Methyl-2,5-dimethoxyamphetamine (DOM) |
2 g |
| 5-Methoxy-3,4-methylenedioxyamphetamine |
2 g |
| 5-Methoxy-N,N-diisopropyltryptamine |
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 |
2 g |
| Alpha-methylfentanyl |
2 g |
| Alpha-methylthiofentanyl |
2 g |
| Alpha-methyltryptamine (AMT) |
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 |
4 g |
| Codeine-N-oxide |
602 g |
| Diethyltryptamine |
2 g |
| Difenoxin |
3,000 g |
| Dihydromorphine |
3,608,000 g |
| Dimethyltryptamine |
7 g |
| Gamma-hydroxybutyric acid |
3,000,000 g |
| Heroin |
20 g |
| Hydromorphinol |
2 g |
| Hydroxypethidine |
2 g |
| Ibogaine |
5 g |
| Lysergic acid diethylamide (LSD) |
16 g |
| Marihuana |
21,000 g |
| Mescaline |
5 g |
| Methaqualone |
10 g |
| Methcathinone |
4 g |
| Methyldihydromorphine |
2 g |
| Morphine-N-oxide |
605 g |
| N-Benzylpiperazine |
2 g |
| N,N-Dimethylamphetamine |
2 g |
| N-Ethylamphetamine |
2 g |
| N-Hydroxy-3,4-methylenedioxyamphetamine |
2 g |
| Noracymethadol |
2 g |
| Norlevorphanol |
52 g |
| Normethadone |
2 g |
| Normorphine |
18 g |
| Para-fluorofentanyl |
2 g |
| Phenomorphan |
2 g |
| Pholcodine |
2 g |
| Psilocybin |
2 g |
| Psilocyn |
2 g |
| Tetrahydrocannabinols |
393,000 g |
| Thiofentanyl |
2 g |
| Tilidine |
10 g |
| Trimeperidine |
2 g |
| Basic class--Schedule II |
Established 2011 quotas |
| 1-Phenylcyclohexylamine |
2 g |
| 1-piperdinocyclohexanecarbonitrile |
2 g |
| 4-Anilino-N-phenethyl-4-piperidine (ANPP) |
2,500,000 g |
| Alfentanil |
8,000 g |
| Alphaprodine |
2 g |
| Amobarbital |
40,007 g |
| Amphetamine (for conversion) |
7,500,000 g |
| Amphetamine (for sale) |
18,600,000 g |
| Cocaine |
247,000 g |
| Codeine (for conversion) |
65,000,000 g |
| Codeine (for sale) |
39,605,000 g |
| Dextropropoxyphene |
92,000,000 g |
| Dihydrocodeine |
800,000 g |
| Diphenoxylate |
827,000 g |
| Ecgonine |
83,000 g |
| Ethylmorphine |
2 g |
| Fentanyl |
1,428,000 g |
| Glutethimide |
2 g |
| Hydrocodone (for sale) |
55,000,000 g |
| Hydromorphone |
3,455,000 g |
| Isomethadone |
11 g |
| Levo-alphacetylmethadol (LAAM) |
3 g |
| Levomethorphan |
5 g |
| Levorphanol |
10,000 g |
| Lisdexamfetamine |
9,000,000 g |
| Meperidine |
6,600,000 g |
| Meperidine Intermediate-A |
3 g |
| Meperidine Intermediate-B |
7 g |
| Meperidine Intermediate-C |
3 g |
| Metazocine |
5 g |
| Methadone (for sale) |
20,000,000 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 conversion) |
83,000,000 g |
| Morphine (for sale) |
39,000,000 g |
| Nabilone |
10,502 g |
| Noroxymorphone (for conversion) |
9,000,000 g |
| Noroxymorphone (for sale) |
401,000 g |
| Opium (powder) |
230,000 g |
| Opium (tincture) |
1,500,000 g |
| Oripavine |
15,000,000 g |
| Oxycodone (for conversion) |
5,600,000 g |
| Oxycodone (for sale) |
105,500,000 g |
| Oxymorphone (for conversion) |
12,800,000 g |
| Oxymorphone (for sale) |
3,070,000 g |
| Pentobarbital |
28,000,000 g |
| Phenazocine |
5 g |
| Phencyclidine |
24 g |
| Phenmetrazine |
2 g |
| Phenylacetone |
8,000,000 g |
| Racemethorphan |
2 g |
| Remifentanil |
2,500 g |
| Secobarbital |
260,002 g |
| Sufentanil |
7,000 g |
| Tapentadol |
1,000,000 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 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
$126,400,000 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 10, 2010.
Michele M. Leonhart,
Deputy Administrator.
[FR Doc. 2010-31849 Filed 12-17-10; 8:45 am]
BILLING CODE 4410-09-P
NOTICE: This is an unofficial version. An official version of this publication may be obtained
directly from the Government Printing Office (GPO). |
