2011-27283. 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: [phone].

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

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 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.