2011-23498. Controlled Substances: 2011 Proposed Aggregate Production Quotas

AGENCY:

Drug Enforcement Administration (DEA), Department of Justice.

ACTION:

Notice with request for comments.

SUMMARY:

This notice proposes to adjust the 2011 aggregate production quotas for several controlled substances in schedules I and II of the Controlled Substances Act (CSA) and separately proposes to establish aggregate production quotas for five synthetic cannabinoids temporarily controlled in Schedule I.

DATES:

Electronic comments must be submitted and written comments must be postmarked on or before October 14, 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-343R” on all electronic and written correspondence. DEA encourages 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. Should you, however, wish to submit written comments via regular or express mail, they should be sent to the Drug Enforcement Administration, Attention: DEA Federal Register Representative/ODL, 8701 Morrissette Drive, Springfield, VA 22152.

FOR FURTHER INFORMATION CONTACT:

Christine A. Sannerud, Ph.D., Chief, UN Reporting and Quota Section, 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. On September 15, 2010, a notice of proposed 2011 aggregate production quotas for certain controlled substances in schedules I and II was published in the Federal Register (75 FR 56137). That notice stipulated that the Administrator would adjust, as needed, the quotas in 2011 as provided for in 21 CFR 1303.13. The 2011 established aggregate production quotas were subsequently published in the Federal Register (75 FR 79404) on December 20, 2010.

Additionally, on March 1, 2011, the DEA Administrator published a Final Order 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 (CP-47,497); and 5-(1,1-Dimethyloctyl)-2-[(1R,3S)-3-hydroxycyclohexyl]-phenol (cannabicyclohexanol; CP-47,497 C8 homologue) (76 FR 11075). 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 11075. Aggregate productions quotas for these temporarily scheduled substances have not previously been established.

Analysis for Proposed Revised 2011 Aggregate Production Quotas

DEA now proposes to adjust the established 2011 aggregate production quotas for some schedule I and II controlled substances. In proposing the adjustment, DEA has taken into account the criteria that DEA is required to consider in accordance with 21 CFR 1303.13. DEA proposes the adjustment of the aggregate production quotas for basic classes of schedule I and II controlled substances by considering (1) Changes in demand for the class, changes in the national rate of net disposal for the class, and changes in the rate of net disposal by the registrants holding individual manufacturing quotas for the class; (2) whether any increased demand or changes in the national and/or individual rates of net disposal are temporary, short term, or long term; (3) whether any increased demand can be met through existing inventories, increased individual manufacturing quotas, or increased importation without increasing the aggregate production quota; (4) whether any decreased demand will result in excessive inventory accumulation by all persons registered to handle the class; and (5) other factors affecting the medical, scientific, research, and industrial needs in the United States and lawful export requirements, as the Administrator finds relevant.

In determining whether to propose adjustments to the 2011 aggregate production quotas, DEA considered updated information obtained from 2010 year-end inventories, 2010 disposition data submitted by quota applicants, estimates of the medical needs of the United States, product development, and other information made available to DEA after the initial aggregate production quotas had been established. The Administrator, therefore, proposes to adjust the 2011 aggregate production quotas for some schedule I and II controlled substances, expressed in grams of anhydrous acid or base, as follows:

Basic class-schedule I	Previously established initial 2011 quotas	Proposed adjusted 2011 quotas
1-Methyl-4-phenyl-4-propionoxypiperidine	2 g	No Change.
2,5-Dimethoxyamphetamine	2 g	No Change.
2,5-Dimethoxy-4-ethylamphetamine (DOET)	2 g	No Change.
2,5-Dimethoxy-4-n-propylthiophenethylamine	2 g	No Change.
3-Methylfentanyl	2 g	No Change.
3-Methylthiofentanyl	2 g	No Change.
3,4-Methylenedioxyamphetamine (MDA)	22 g	No Change.
3,4-Methylenedioxy-N-ethylamphetamine (MDEA)	15 g	No Change.
3,4-Methylenedioxymethamphetamine (MDMA)	22 g	No Change.
3,4,5-Trimethoxyamphetamine	2 g	No Change.
4-Bromo-2,5-dimethoxyamphetamine (DOB)	2 g	No Change.
4-Bromo-2,5-dimethoxyphenethylamine (2-CB)	2 g	No Change.
4-Methoxyamphetamine	77 g	No Change.
4-Methylaminorex	2 g	No Change.
4-Methyl-2,5-dimethoxyamphetamine (DOM)	2 g	No Change.
5-Methoxy-3,4-methylenedioxyamphetamine	2 g	No Change.
5-Methoxy-N,N-diisopropyltryptamine	2 g	No Change.
Acetyl-alpha-methylfentanyl	2 g	No Change.
Acetyldihydrocodeine	2 g	No Change.
Acetylmethadol	2 g	No Change.
Allylprodine	2 g	No Change.
Alphacetylmethadol	2 g	No Change.
Alpha-ethyltryptamine	2 g	No Change.
Alphameprodine	2 g	No Change.
Alphamethadol	2 g	No Change.
Alpha-methylfentanyl	2 g	No Change.
Alpha-methylthiofentanyl	2 g	No Change.
Alpha-methyltryptamine (AMT)	2 g	No Change.
Aminorex	2 g	No Change.
Benzylmorphine	2 g	No Change.
Betacetylmethadol	2 g	No Change.
Beta-hydroxy-3-methylfentanyl	2 g	No Change.
Beta-hydroxyfentanyl	2 g	No Change.
Betameprodine	2 g	No Change.
Betamethadol	2 g	No Change.
Betaprodine	2 g	No Change.
Bufotenine	3 g	No Change.
Cathinone	4 g	No Change.
Codeine-N-oxide	602 g	No Change.
Diethyltryptamine	2 g	No Change.
Difenoxin	3,000 g	50 g.
Dihydromorphine	3,608,000 g	No Change.
Dimethyltryptamine	7 g	No Change.
Gamma-hydroxybutyric acid	3,000,000 g	5,434,000 g.
Heroin	20 g	No Change.
Hydromorphinol	2 g	No Change.
Hydroxypethidine	2 g	No Change.
Ibogaine	5 g	No Change.
Lysergic acid diethylamide (LSD)	16 g	No Change.
Marihuana	21,000 g	No Change.
Mescaline	5 g	No Change.
Methaqualone	10 g	No Change.
Methcathinone	4 g	No Change.
Methyldihydromorphine	2 g	No Change.
Morphine-N-oxide	605 g	No Change.
N-Benzylpiperazine	2 g	No Change.
N,N-Dimethylamphetamine	2 g	No Change.
N-Ethylamphetamine	2 g	No Change.
N-Hydroxy-3,4-methylenedioxyamphetamine	2 g	No Change.
Noracymethadol	2 g	No Change.
Norlevorphanol	52 g	No Change.
Normethadone	2 g	No Change.
Normorphine	18 g	No Change.
Para-fluorofentanyl	2 g	No Change.
Phenomorphan	2 g	No Change.
Pholcodine	2 g	No Change.
Psilocybin	2 g	No Change.
Psilocyn	2 g	No Change.
Tetrahydrocannabinols	393,000 g	No Change.
Thiofentanyl	2 g	No Change.
Tilidine	10 g	No Change.
Trimeperidine	2 g	No Change.

Basic class—schedule II	Previously established initial 2011 quotas	Proposed adjusted 2011 quotas
1-Phenylcyclohexylamine	2 g	No Change.
1-Piperdinocyclohexanecarbonitrile	2 g	No Change.
4-Anilino-N-phenethyl-4-piperidine (ANPP)	2,500,000 g	1,800,000 g.
Alfentanil	8,000 g	11,600 g.
Alphaprodine	2 g	No Change.
Amobarbital	40,007 g	No Change.
Amphetamine (for conversion)	7,500,000 g	8,500,000 g.
Amphetamine (for sale)	18,600,000 g	25,300,000 g.
Cocaine	247,000 g	216,000 g.
Codeine (for conversion)	65,000,000 g	No Change.
Codeine (for sale)	39,605,000 g	No Change.
Dextropropoxyphene	92,000,000 g	7 g.
Dihydrocodeine	800,000 g	255,000 g.
Diphenoxylate	827,000 g	500,000 g.
Ecgonine	83,000 g	No Change.
Ethylmorphine	2 g	No Change.
Fentanyl	1,428,000 g	No Change.
Glutethimide	2 g	No Change.
Hydrocodone (for sale)	55,000,000 g	59,000,000 g.
Hydromorphone	3,455,000 g	No Change.
Isomethadone	11 g	2 g.
Levo-alphacetylmethadol (LAAM)	3 g	No Change.
Levomethorphan	5 g	2 g.
Levorphanol	10,000 g	3,600 g.
Lisdexamfetamine	9,000,000 g	10,400,000 g.
Meperidine	6,600,000 g	5,200,000 g.
Meperidine Intermediate-A	3 g	No Change.
Meperidine Intermediate-B	7 g	No Change.
Meperidine Intermediate-C	3 g	No Change.
Metazocine	5 g	No Change.
Methadone (for sale)	20,000,000 g	No Change.
Methadone Intermediate	26,000,000 g	No Change.
Methamphetamine	3,130,000 g	No Change.
[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	50,000,000 g	56,000,000 g.
Morphine (for conversion)	83,000,000 g	70,000,000 g.
Morphine (for sale)	39,000,000 g	No Change.
Nabilone	10,502 g	No Change.
Noroxymorphone (for conversion)	9,000,000 g	7,200,000 g.
Noroxymorphone (for sale)	401,000 g	No Change.
Opium (powder)	230,000 g	63,000 g.
Opium (tincture)	1,500,000 g	1,000,000 g.
Oripavine	15,000,000 g	8,000,000 g.
Oxycodone (for conversion)	5,600,000 g	No Change.
Oxycodone (for sale)	105,500,000 g	98,000,000 g.
Oxymorphone (for conversion)	12,800,000 g	No Change.
Oxymorphone (for sale)	3,070,000 g	No Change.
Pentobarbital	28,000,000 g	31,000,000 g.
Phenazocine	5 g	No Change.
Phencyclidine	24 g	No Change.
Phenmetrazine	2 g	No Change.
Phenylacetone	8,000,000 g	No Change.
Racemethorphan	2 g	No Change.
Remifentanil	2,500 g	No Change.
Secobarbital	260,002 g	336,002 g.
Sufentanil	7,000 g	5,000 g.
Tapentadol	1,000,000 g	403,000 g.
Thebaine	126,000,000 g	116,000,000 g.

Aggregate production quotas for all other schedule I and II controlled substances included in 21 CFR 1308.11 and 1308.12 remain at zero.

Analysis for Proposed Aggregate Production Quotas for Temporarily Scheduled Substances

The proposed year 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 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 year 2011 aggregate production quotas for the five temporarily scheduled controlled substances listed below, the Administrator considered the following factors, in accordance with 21 U.S.C. 826(a) and 21 CFR 1303.11: Total estimated net disposal of each substance by all manufacturers; total estimated inventories of the class and of all substances manufactured in the class; projected demand for such class as indicated by procurement quotas requested pursuant to 21 CFR 1303.12; and other factors affecting medical, scientific, research, and industrial needs of the United States and lawful export requirements.

DEA has received applications for registration and quota for the temporarily scheduled controlled substances listed below. In examining the information provided by the applicant(s), along with other information, DEA finds that there is a current need for these substances. The Administrator therefore proposes that the year 2011 aggregate production quotas for the following controlled substances, expressed in grams of anhydrous acid or base, be established as follows:

Basic class-schedule I	Proposed 2011 quotas
1-[2-(4-Morpholinyl)ethyl]-3-(1-naphthoyl)indole (JWH-200)	45 g
1-Butyl-3-(1-naphthoyl)indole (JWH-073)	45 g
1-Pentyl-3-(1-naphthoyl)indole (JWH-018)	45 g
5-(1,1-Dimethylheptyl)-2-[(1R,3S)-3-hydroxycyclohexyl]-phenol (CP-47,497)	68 g
5-(1,1-Dimethyloctyl)-2-[(1R,3S)-3-hydroxycyclohexyl]-phenol (cannabicyclohexanol; CP-47,497 C8 homologue)	53 g

Pursuant to 21 CFR part 1303, the Administrator may adjust the 2011 aggregate production quotas and individual manufacturing quotas allocated for the year.

Comments

Pursuant to 21 CFR 1303.11 and 1303.13, 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 any adjustment of the aggregate production quota.

Dated: September 2, 2011.

Michele M. Leonhart,

Administrator.