Quotas - 2011
[Federal Register Volume 76, Number 237 (Friday, December 9, 2011)]
[Notices]
[Pages 77016-77019]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-31621]
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA-343F]
Controlled Substances: Final Adjusted Aggregate Production Quotas for 2011
AGENCY: Drug Enforcement Administration (DEA), Department of Justice.
ACTION: Notice.
SUMMARY: This notice establishes final adjusted 2011 aggregate
production quotas for controlled substances in Schedules I and II of
the Controlled Substances Act (CSA).
FOR FURTHER INFORMATION CONTACT: John W. Partridge, Chief, Liaison and
Policy Section, Drug Enforcement Administration, 8701 Morrissette
Drive, Springfield, VA 22152, Telephone: (202) 307-4564.
SUPPLEMENTARY INFORMATION:
Background
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. In accordance with 21 U.S.C. 826 and 21 CFR
1303.11, DEA published in the Federal Register on December 20, 2010,
notice of the established 2011 aggregate production quotas for
controlled substances in Schedules I and II (75 FR 79404). That notice
stated that the Administrator would adjust, as needed, the established
aggregate production quotas in 2011 as provided for in 21 CFR 1303.13.
The 2011 proposed adjusted aggregate production quotas were
subsequently published in the Federal Register on September 14, 2011,
(76 FR 56810) in consideration of the outlined criteria. All interested
persons were invited to comment on or object to the proposed adjusted
aggregate production quotas on or before October 14, 2011.
The September 14, 2011, proposed adjusted aggregate production
quotas also included proposed aggregate production quotas for five
newly scheduled substances. On March 1, 2011, the DEA Administrator
published a final order (76 FR 11075) which temporarily placed five
synthetic cannabinoids in Schedule I: 1-[2-(4-Morpholinyl)ethyl]-3-(1-
naphthoyl)indole (JWH-200); 1-Butyl-3-(1-naphthoyl)indole (JWH-073); 1-
Pentyl-3-(1-naphthoyl)indole (JWH-018); 5-(1,1-Dimethylheptyl)-2-
[(1R,3S)-3-hydroxycyclohexyl]-phenol; and 5-(1,1-Dimethyloctyl)-2-
[(1R,3S)-3-hydroxycyclohexyl]-phenol. That final order stated that
quotas for the five substances would be "established based on
registrations granted and quota applications received pursuant to part
1303 of Title 21 of the Code of Federal Regulations." 76 FR 11077.
Aggregate production quotas for these newly scheduled substances had
not been previously established and were initially proposed in the
above referenced notice published in the Federal Register on September
14, 2011 (76 FR 56810). All interested persons were invited to comment
on or object to the proposed aggregate production quotas on or before
October 14, 2011.
Analysis for Final Adjusted 2011 Aggregate Production Quotas
Consideration has been given to the criteria outlined in the
September 14, 2011, notice of proposed adjusted aggregate production
quotas in accordance with 21 CFR 1303.13. In addition, six companies,
four DEA registered manufacturers and two non-registrants, submitted
timely comments regarding a total of 22 Schedule I and II controlled
substances. Comments received proposed that the aggregate production
quotas for 4-anilino-N-phenethyl-4-piperidine (ANPP), alfentanil,
amphetamine (for sale), diphenoxylate, fentanyl, gamma hydroxybutyric
acid, hydrocodone, meperidine, methadone, methadone
[[Page 77017]]
intermediate, methylphenidate, morphine (for conversion), morphine (for
sale), noroxymorphone (for conversion), noroxymorphone (for sale),
oxycodone (for sale), oxymorphone (for conversion), oxymorphone (for
sale), pentobarbital, secobarbital, sufentanil, 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 2010 year-end inventories, initial 2011 manufacturing
quotas, 2011 export requirements, actual and projected 2011 sales,
research and product development requirements, and additional
applications received.
Based on all of the above, the Administrator has determined that
the proposed adjusted 2011 aggregate production quotas for alfentanil,
diphenoxylate, gamma hydroxybutyric acid, meperidine, and pentobarbital
required additional consideration and hereby further adjusts the 2011
aggregate production quotas for those substances.
Regarding 4-anilino-N-phenethyl-4-piperidine (ANPP), amphetamine
(for sale), fentanyl, hydrocodone, methadone, methadone intermediate,
methylphenidate, morphine (for conversion), morphine (for sale),
noroxymorphone (for conversion), noroxymorphone (for sale), oxycodone
(for sale), oxymorphone (for conversion), oxymorphone (for sale),
secobarbital, sufentanil, and thebaine, the Administrator hereby
determines that the proposed adjusted 2011 aggregate production quotas
for these substances as published on September 14, 2011, at 76 FR 56810
are sufficient to meet the current 2011 estimated medical, scientific,
research, and industrial needs of the United States and to provide for
adequate inventories.
Pursuant to the above, the Administrator hereby establishes the
2011 final aggregate production quotas for Schedule I and II controlled
substances, including the five newly scheduled substances previously
referenced, expressed in grams of anhydrous acid or base, as follows:
| Basic class—Schedule I |
Final adjusted
2011 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-Methylenedioxymethamphetamine (MDMA) |
22 |
| 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 |
| 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 |
5,772,000 |
| Heroin |
20 |
| Hydromorphinol |
2 |
| Hydroxypethidine |
2 |
| Ibogaine |
5 |
| Lysergic acid diethylamide (LSD) |
16 |
| Marihuana |
21,000 |
| Mescaline |
5 |
| Methaqualone |
10 |
| Methcathinone |
4 |
| Methyldihydromorphine |
2 |
| Morphine-N-oxide |
605 |
| 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 |
| Psilocybin |
2 |
| Psilocyn |
2 |
| Tetrahydrocannabinols |
393,000 |
| Thiofentanyl |
2 |
| Tilidine |
10 |
| Trimeperidine |
2 |
[[Page 77018]]
| Basic class—Schedule II |
Final adjusted
2011 quotas (g) |
| 1-Phenylcyclohexylamine |
2 |
| 1-Piperdinocyclohexanecarbonitrile |
2 |
| 4-Anilino-N-phenethyl-4-piperidine (ANPP) |
1,800,000 |
| Alfentanil |
12,800 |
| 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 |
255,000 |
| Diphenoxylate |
730,000 |
| Ecgonine |
83,000 |
| Ethylmorphine |
2 |
| Fentanyl |
1,428,000 |
| Glutethimide |
2 |
| Hydrocodone (for sale) |
59,000,000 |
| Hydromorphone |
3,455,000 |
| Isomethadone |
2 |
| Levo-alphacetylmethadol (LAAM) |
3 |
| Levomethorphan |
2 |
| Levorphanol |
3,600 |
| Lisdexamfetamine |
10,400,000 |
| Meperidine |
5,500,000 |
| Meperidine Intermediate-A |
3 |
| Meperidine Intermediate-B |
7 |
| Meperidine Intermediate-C |
3 |
| Metazocine |
5 |
| Methadone (for sale) |
20,000,000 |
| Methadone Intermediate |
26,000,000 |
| Methamphetamine |
3,130,000 |
| Methylphenidate |
56,000,000 |
| Morphine (for conversion) |
70,000,000 |
| Morphine (for sale) |
39,000,000 |
| Nabilone |
10,502 |
| Noroxymorphone (for conversion) |
7,200,000 |
| Noroxymorphone (for sale) |
401,000 |
| Opium (powder) |
63,000 |
| Opium (tincture) |
1,000,000 |
| Oripavine |
8,000,000 |
| Oxycodone (for conversion) |
5,600,000 |
| Oxycodone (for sale) |
98,000,000 |
| Oxymorphone (for conversion) |
12,800,000 |
| Oxymorphone (for sale) |
3,070,000 |
| Pentobarbital |
34,000,000 |
| Phenazocine |
5 |
| Phencyclidine |
24 |
| Phenmetrazine |
2 |
| Phenylacetone |
8,000,000 |
| Racemethorphan |
2 |
| Remifentanil |
2,500 |
| Secobarbital |
336,002 |
| Sufentanil |
5,000 |
| Tapentadol |
403,000 |
| Thebaine |
116,000,000 |
[[Page 77019]]
Aggregate production quotas for all other Schedule I and II
controlled substances included in 21 CFR 1308.11 and 1308.12 remain at
zero.
Dated: December 1, 2011.
Michele M. Leonhart,
Administrator.
[FR Doc. 2011-31621 Filed 12-8-11; 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). |
