Quotas - 2011
[Federal Register Volume 76, Number 241 (Thursday, December 15, 2011)]
[Notices]
[Pages 78044-78047]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-32163]
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA 358E]
Controlled Substances: Established Aggregate Production Quotas for 2012
AGENCY: Drug Enforcement Administration (DEA), Department of Justice.
ACTION: Notice.
SUMMARY: This notice establishes the initial 2012 aggregate production
quotas for controlled substances in Schedules I and II of the
Controlled Substances Act (CSA).
DATES: Effective Date: December 15, 2011.
FOR FURTHER INFORMATION CONTACT: John W. Partridge, Office of Diversion
Control, Drug Enforcement Administration, 8701 Morrissette Drive,
Springfield, VA 22152, Telephone: (202) 307-4654.
SUPPLEMENTARY INFORMATION: Section 306 of the Controlled Substances Act
(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 2012 aggregate production quotas represent those quantities of
Schedule I and II controlled substances that may be produced in the
United States in 2012 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 October 21, 2011, a notice entitled "Controlled Substances:
Proposed Aggregate Production Quotas for 2012" was published in the
Federal Register (76 FR 65537). That notice proposed the 2012 aggregate
production quotas for each basic class of controlled substance listed
in Schedules I and II. All interested persons were invited to comment
on or object to the proposed aggregate production quotas on or before
November 21, 2011.
Sixteen responses (eleven from DEA registered manufacturers, and
five from other members of the public) were received within the
published comment period, offering comments on a total of 37 Schedule I
and II controlled substances. Several comments discussed the national
prescription drug abuse epidemic and urged DEA to reduce quotas for
prescription painkillers and opioids. Addressing prescription drug
abuse requires a multi-faceted approach which includes education,
treatment, and enforcement.
The quota system is specifically designed to operate within the
statutory framework of the CSA, in conjunction with other controls to
enable DEA to monitor the movement of controlled substances and certain
chemicals into and through the closed system of distribution to help
prevent diversion of such substances into the illicit market. Through
the quota system, DEA limits the amount of those substances and
chemicals manufactured each year to those quantities that will provide
for the estimated medical, scientific, research, and industrial needs,
lawful export requirements, and the establishment and maintenance of
reserve stocks for the United States. All aspects of the closed system
of distribution must work together to reduce or eliminate the diversion
of controlled substances.
Other commenters stated that the proposed aggregate production
quotas for alfentanil, amphetamine (for sale), codeine (for
conversion), codeine (for sale), dihydrocodeine, dihydromorphine,
diphenoxylate, hydrocodone (for sale), hydromorphinol, levorphanol,
lisdexamfetamine, meperidine, meperidine intermediate A, meperidine
intermediate B, meperidine intermediate C, methadone, methadone
intermediate, methamphetamine, methylphenidate, morphine (for
conversion), morphine (for sale), morphine-N-oxide, nabilone,
noroxymorphone (for conversion), noroxymorphone (for sale), opium
(tincture), oripavine, oxycodone (for conversion), oxycodone (for
sale),
[[Page 78045]]
oxymorphone (for conversion), oxymorphone (for sale), pentobarbital,
phenylacetone, properidine, sufentanil, tapentadol, and thebaine were
insufficient to provide for the estimated medical, scientific,
research, and industrial needs of the United States, export
requirements, and the establishment and maintenance of reserve stocks.
In determining the aggregate production quotas, DEA has taken into
consideration the above comments along with the factors set forth at 21
CFR 1303.11(b), in accordance with 21 U.S.C. 826(a) and other relevant
factors, including the consideration of 2011 manufacturing quotas,
current 2011 sales and inventories, 2012 export requirements,
additional applications for quotas, as well as information on research
and product development requirements. Based on this information, DEA
determined that adjustments to the proposed aggregate production quotas
for alfentanil, dihydrocodeine, diphenoxylate, hydromorphinol,
lisdexamfetamine, meperidine, meperidine intermediate A, meperidine
intermediate B, meperidine intermediate C, morphine-N-oxide, nabilone,
pentobarbital, phenylacetone, properidine, and tapentadol are
warranted. This notice reflects those adjustments.
When DEA published the Proposed Aggregate Production Quotas for
2012 on October 21, 2011, that notice proposed that all Schedule I and
II controlled substances included in 21 CFR 1308.11 and 1308.21 but not
specifically referenced in that notice be established at zero. That
reference extended to the three synthetic cathinones (4-methyl-N-
methylcathinone; 3,4-methylenedioxy-N-methylcathinone; and
3,4,methylenedioxypyrovalerone) that were temporarily placed in
Schedule I pursuant to the final order also published on October 21,
2011, at 76 FR 65371. No comments were received within the published
comment period regarding the proposed quota for the three synthetic
cathinones, however, DEA has determined, based on the information
described above, that an increase from the proposed quota of zero is
warranted for all three substances. This notice reflects those
adjustments.
Regarding amphetamine (for sale), codeine (for conversion), codeine
(for sale), dihydromorphine, hydrocodone (for sale), levorphanol,
methadone, methadone intermediate, methamphetamine, methylphenidate,
morphine (for conversion), morphine (for sale), noroxymorphone (for
conversion), noroxymorphone (for sale), opium (tincture), oripavine,
oxycodone (for conversion), oxycodone (for sale), oxymorphone (for
conversion), oxymorphone (for sale), sufentanil, and thebaine, DEA has
determined that the proposed initial 2012 aggregate production quotas
are sufficient to meet the current 2012 estimated medical, scientific,
research, and industrial needs of the United States. This notice
finalizes these aggregate production quotas at the same amounts as
proposed.
In accordance with 21 U.S.C. 826 and 21 CFR 1303.11, the
Administrator hereby determines that the 2012 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 2012
Quotas (g) |
| 1-[2-(4-Morpholinyl)ethyl]-3-(1-naphthoyl)indole (JWH-200) |
45 |
| 1-Butyl-3-(1-naphthoyl)indole (JWH-073) |
45 |
| 1-Methyl-4-phenyl-4-propionoxypiperidine |
2 |
| 1-Pentyl-3-(1-naphthoyl)indole (JWH-018) |
45 |
| 2,5-Dimethoxyamphetamine |
2 |
| 2,5-Dimethoxy-4-ethylamphetamine (DOET) |
2 |
| 2,5-Dimethoxy-4-n-propylthiophenethylamine |
2 |
| 3-Methylfentanyl |
2 |
| 3-Methylthiofentanyl |
2 |
| 3,4-Methylenedioxyamphetamine (MDA) |
22 |
| 3,4-Methylenedioxy-N-ethylamphetamine (MDEA) |
15 |
| 3,4–Methylenedioxy-N-methylcathinone (methylone) |
8 |
| 3,4-Methylenedioxymethamphetamine (MDMA) |
22 |
| 3,4–Methylenedioxypyrovalerone (MDPV) |
8 |
| 3,4,5-Trimethoxyamphetamine |
2 |
| 4-Bromo-2,5-dimethoxyamphetamine (DOB) |
2 |
| 4-Bromo-2,5-dimethoxyphenethylamine (2-CB) |
2 |
| 4-Methoxyamphetamine |
77 |
| 4-Methylaminorex |
2 |
| 4-Methyl-2,5-dimethoxyamphetamine (DOM) |
2 |
| 4–Methyl-N-methylcathinone (mephedrone) |
8 |
| 5-(1,1-Dimethylheptyl)-2-[(1R,3S)-3-hydroxycyclohexyl]-phenol |
68 |
| 5-(1,1-Dimethyloctyl)-2-[(1R,3S)-3-hydroxycyclohexyl]-phenol |
53 |
| 5-Methoxy-3,4-methylenedioxyamphetamine |
2 |
| 5-Methoxy-N,N-diisopropyltryptamine |
2 |
| Acetyl-alpha-methylfentanyl |
2 |
| Acetyldihydrocodeine |
2 |
| Acetylmethadol |
2 |
| Allylprodine |
2 |
| Alphacetylmethadol |
2 |
| Alpha-ethyltryptamine |
2 |
| Alphameprodine |
2 |
| Alphamethadol |
2 |
| Alpha-methylfentanyl |
2 |
| Alpha-methylthiofentanyl |
2 |
| Alpha-methyltryptamine (AMT) |
2 |
| Aminorex |
2 |
| Benzylmorphine |
2 |
| Betacetylmethadol |
2 |
| Beta-hydroxy-3-methylfentanyl |
2 |
| Beta-hydroxyfentanyl |
2 |
| Betameprodine |
2 |
| Betamethadol |
2 |
| Betaprodine |
2 |
| Bufotenine |
3 |
| Cathinone |
4 |
| Codeine-N-oxide |
602 |
| Diethyltryptamine |
2 |
| Difenoxin |
50 |
| Dihydromorphine |
3,608,000 |
| Dimethyltryptamine |
7 |
| Gamma-hydroxybutyric acid |
47,000,000 |
| Heroin |
20 |
| Hydromorphinol |
54 |
| Hydroxypethidine |
2 |
| Ibogaine |
5 |
| Lysergic acid diethylamide (LSD) |
16 |
| Marihuana |
21,000 |
| Mescaline |
5 |
| Methaqualone |
10 |
| Methcathinone |
4 |
| Methyldihydromorphine |
2 |
| Morphine-N-oxide |
655 |
| N-Benzylpiperazine |
2 |
| N,N-Dimethylamphetamine |
2 |
| N-Ethylamphetamine |
2 |
| N-Hydroxy-3,4-methylenedioxyamphetamine |
2 |
| Noracymethadol |
2 |
| Norlevorphanol |
52 |
| Normethadone |
2 |
| Normorphine |
18 |
| Para-fluorofentanyl |
2 |
| Phenomorphan |
2 |
| Pholcodine |
2 |
| Properidine |
2 |
| Psilocybin |
2 |
| Psilocyn |
2 |
| Tetrahydrocannabinols |
393,000 |
| Thiofentanyl |
2 |
| Tilidine |
10 |
| Trimeperidine |
2 |
| Basic class—Schedule II |
Established 2012
Quotas (g) |
| 1-Phenylcyclohexylamine |
2 |
| 1-Piperdinocyclohexanecarbonitrile |
2 |
| 4-Anilino-N-phenethyl-4-piperidine (ANPP) |
1,800,000 |
| Alfentanil |
15,000 |
| Alphaprodine |
2 |
| Amobarbital |
40,007 |
| Amphetamine (for conversion) |
8,500,000 |
| Amphetamine (for sale) |
25,300,000 |
| Cocaine |
216,000 |
| Codeine (for conversion) |
65,000,000 |
| Codeine (for sale) |
39,605,000 |
| Dextropropoxyphene |
7 |
| Dihydrocodeine |
400,000 |
| Diphenoxylate |
900,000 |
| Ecgonine |
83,000 |
| Ethylmorphine |
2 |
| Fentanyl |
1,428,000 |
| Glutethimide |
2 |
| Hydrocodone (for sale) |
59,000,000 |
| Hydromorphone |
3,455,000 |
| Isomethadone |
4 |
| Levo-alphacetylmethadol (LAAM) |
3 |
| Levomethorphan |
5 |
| Levorphanol |
3,600 |
| Lisdexamfetamine |
12,000,000 |
| Meperidine |
5,500,000 |
| Meperidine Intermediate-A |
5 |
| Meperidine Intermediate-B |
9 |
| Meperidine Intermediate-C |
5 |
| Metazocine |
5 |
| Methadone (for sale) |
20,000,000 |
| Methadone Intermediate |
26,000,000 |
| Methamphetamine |
3,130,000 |
| [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)] |
| Methylphenidate |
56,000,000 |
| Morphine (for conversion) |
83,000,000 |
| Morphine (for sale) |
39,000,000 |
| Nabilone |
20,502 |
| Noroxymorphone (for conversion) |
7,200,000 |
| Noroxymorphone (for sale) |
401,000 |
| Opium (powder) |
63,000 |
| Opium (tincture) |
1,000,000 |
| Oripavine |
9,800,000 |
| Oxycodone (for conversion) |
5,600,000 |
| Oxycodone (for sale) |
98,000,000 |
| Oxymorphone (for conversion) |
12,800,000 |
| Oxymorphone (for sale) |
5,500,000 |
| Pentobarbital |
34,000,000 |
| Phenazocine |
5 |
| Phencyclidine |
24 |
| Phenmetrazine |
2 |
| Phenylacetone |
16,000,000 |
| Racemethorphan |
2 |
| Remifentanil |
2,500 |
| Secobarbital |
336,002 |
| Sufentanil |
5,000 |
| Tapentadol |
5,400,000 |
| Thebaine |
116,000,000 |
[[Page 78047]]
The Administrator further determines that aggregate production
quotas for all other Schedule I and II controlled substances included
in 21 CFR 1308.11 and 1308.12 be established at zero. All aggregate
production quotas are subject to adjustment pursuant to 21 CFR 1303.13.
Dated: December 8, 2011.
Michele M. Leonhart,
Administrator.
[FR Doc. 2011-32163 Filed 12-14-11; 8:45 am]
BILLING CODE 4410-09-P
NOTICE: This is an unofficial version. An official version of this publication may be obtained
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