Quotas - 2011
[Federal Register Volume 76, Number 204 (Friday, October 21, 2011)]
[Notices]
[Pages 65537-65540]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-27283]
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA-358]
Controlled Substances: Proposed Aggregate Production Quotas for
2012
AGENCY: Drug Enforcement Administration (DEA), Department of Justice.
ACTION: Notice with request for comment.
SUMMARY: This notice proposes initial year 2012 aggregate production
quotas for controlled substances in Schedules I and II of the
Controlled Substances Act (CSA).
DATES: Electronic comments must be submitted and written comments must
be postmarked on or before November 21, 2011. Commenters should be
aware that the electronic Federal Docket Management System will not
accept comments after midnight Eastern Time on the last day of the
comment period.
ADDRESSES: To ensure proper handling of comments, please reference
"Docket No. DEA-358" on all electronic and written correspondence.
DEA encourages that all comments be submitted electronically through
http://www.regulations.gov using the electronic comment form provided
on that site. An electronic copy of this document is also available at
the http://www.regulations.gov Web site for easy reference. Paper
comments that duplicate the electronic submission are not necessary as
all comments submitted to http://www.regulations.gov will be posted for
public review and are part of the official docket record. Written
comments submitted via regular or express mail should be sent to the
Drug Enforcement Administration, Attention: DEA Federal Register
Representative/OD, 8701 Morrissette Drive, Springfield, VA 22152.
FOR FURTHER INFORMATION CONTACT: Rhea D. Moore, Office of Diversion
Control, Drug Enforcement Administration, 8701 Morrissette Drive,
Springfield, VA 22152, Telephone: (202) 307-7165.
SUPPLEMENTARY INFORMATION:
Posting of Public Comments
Please note that all comments received are considered part of the
public record and made available for public inspection online at http://www.regulations.gov and in the DEA's public docket. Such information
includes personal identifying information (such as your name, address,
etc.) voluntarily submitted by the commenter.
If you want to submit personal identifying information (such as
your name, address, etc.) as part of your comment, but do not want it
to be posted online or made available in the public docket, you must
include the phrase "PERSONAL IDENTIFYING INFORMATION" in the first
paragraph of your comment. You must also place all the personal
identifying information you do not want posted online or made available
in the public docket in the first paragraph of your comment and
identify what information you want redacted.
If you want to submit confidential business information as part of
your comment, but do not want it to be posted online or made available
in the public docket, you must include the phrase "CONFIDENTIAL
BUSINESS INFORMATION" in the first paragraph of your comment. You must
also prominently identify confidential business information to be
redacted within the comment. If a comment has so much confidential
business information that it cannot be effectively redacted, all or
part of that comment may not be posted online or made available in the
public docket.
Personal identifying information and confidential business
information identified and located as set forth above will be redacted,
and the comment, in redacted form, will be posted online and placed in
the DEA's public docket file. Please note that the Freedom of
Information Act applies to all comments received. If you wish to
inspect the agency's public docket file in person by appointment,
please see the FOR FURTHER INFORMATION CONTACT paragraph.
Background
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 proposed year 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. These quotas do
not include imports of controlled substances for use in industrial
processes.
In determining the proposed 2012 aggregate production quotas, the
DEA has taken into account the criteria that DEA is required to
consider in accordance with 21 U.S.C. 826(a) and 21 CFR 1303.11. DEA
proposes the aggregate production quotas for 2012 by considering (1)
total net disposal of the class by all manufacturers during the current
and two preceding years; (2) trends in the national rate of net
disposal of the class; (3) total actual (or estimated) inventories of
the class and of all substances manufactured from the class, and trends
in inventory accumulation; (4) projected demand for such class as
indicated by procurement quotas requested pursuant to 21 CFR 1303.12;
and (5) other factors affecting the medical, scientific, research, and
industrial needs in the United States, lawful export requirements, and
reserve stocks, as the Administrator finds relevant. Other factors DEA
considered include product development requirements of both bulk and
finished dosage form manufacturers, and other pertinent information.
The Administrator, therefore, proposes that the year 2012 aggregate
production quotas for the following Schedule I and II controlled
substances, expressed in grams of anhydrous acid or base, be
established as follows:
| Basic class—Schedule I |
Proposed 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-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 |
29,000,000 |
| 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 65539]]
| Basic class—Schedule II |
Proposed 2012
quotas
(g) |
| 1-Phenylcyclohexylamine |
2 |
| 1-Piperdinocyclohexanecarbonitrile |
2 |
| 4-Anilino-N-phenethyl-4-piperidine (ANPP) |
1,800,000 |
| Alfentanil |
11,600 |
| 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 |
500,000 |
| 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 |
10,400,000 |
| Meperidine |
5,200,000 |
| 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 |
| [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 |
10,502 |
| 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 |
31,000,000 |
| Phenazocine |
5 |
| Phencyclidine |
24 |
| Phenmetrazine |
2 |
| Phenylacetone |
8,000,000 |
| Racemethorphan |
2 |
| Remifentanil |
2,500 |
| Secobarbital |
336,002 |
| Sufentanil |
5,000 |
| Tapentadol |
243,000 |
| Thebaine |
116,000,000 |
The Administrator further proposes 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. Pursuant to 21 CFR
1303.13, upon consideration of the relevant factors, the Administrator
of the DEA may adjust the 2012 aggregate production quotas as needed.
Comments
Pursuant to 21 CFR 1303.11, any interested person may submit
written comments on or objections to these proposed determinations.
Based on comments received in response to this Notice, the
Administrator may hold a public hearing on one or more issues raised.
In the event the Administrator decides in her sole discretion to hold
[[Page 65540]]
such a hearing, the Administrator will publish a notice of any such
hearing in the Federal Register. After consideration of any comments
and after a hearing, if one is held, the Administrator will publish in
the Federal Register a final order determining the 2012 aggregate
production quota for the basic class of controlled substance.
Dated: October 7, 2011.
Michele M. Leonhart,
Administrator.
[FR Doc. 2011-27283 Filed 10-20-11; 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). |
