2010-22905. Controlled Substances: Proposed Aggregate Production Quotas for 2011

AGENCY:

Drug Enforcement Administration (DEA), Justice.

ACTION:

Notice of proposed year 2011 aggregate production quotas.

SUMMARY:

This notice proposes initial year 2011 aggregate production quotas for controlled substances in schedules I and II of the Controlled Substances Act (CSA).

DATES:

Written comments must be postmarked and electronic comments must be submitted on or before October 15, 2010.

ADDRESSES:

To ensure proper handling of comments, please reference “Docket No. DEA-343P” on all written and electronic correspondence. Written comments sent via regular or express mail should be sent to the Drug Enforcement Administration, Attention: DEA Federal Register Representative/ODL, 8701 Morrissette Drive, Springfield, Virginia 22152. Comments may be sent to DEA by sending an electronic message to [e-mail]. DEA will accept attachments to electronic comments in Microsoft Word, WordPerfect, Adobe PDF, or Excel file formats only. DEA will not accept any file format other than those specifically listed here.

Please note that DEA is requesting that electronic comments be submitted before midnight Eastern Time on the day the comment period closes. Commenters in time zones other than Eastern Time may want to consider this so that their electronic comments are received timely. All comments sent via regular or express mail will be considered timely if postmarked on the day the comment period closes.

FOR FURTHER INFORMATION CONTACT:

Christine A. Sannerud, PhD, Chief, Drug and Chemical Evaluation Section, 8701 Morrissette Drive, Springfield, Virginia 22152, Telephone: [phone].

Availability Of Public Comments: Please note that all comments received are considered part of the public record and made available for public inspection in the Drug Enforcement Administration'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 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 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 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 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 placed in the Drug Enforcement Administration'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 paragraph.

SUPPLEMENTARY INFORMATION:

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 Administrator, in turn, has redelegated this function to the Deputy Administrator, pursuant to 28 CFR 0.104.

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: 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 year 2011 aggregate production quotas, the Deputy Administrator considered the following factors: total actual 2009 and estimated 2010 and 2011 net disposals of each substance by all manufacturers; estimates of 2010 year-end inventories of each substance and of any substance manufactured from it and trends in accumulation of such inventories; product development requirements of both bulk and finished dosage form manufacturers; projected demand as indicated by procurement quota applications filed pursuant to 21 CFR 1303.12; and other pertinent information.

Pursuant to 21 CFR 1303, the Deputy Administrator of the DEA will adjust the 2011 aggregate production quotas and individual manufacturing quotas allocated for the year based upon 2010 year-end inventory and actual 2010 disposition data supplied by quota recipients for each basic class of schedules I or II controlled substances.

Therefore, under the authority vested in the Attorney General by Section 306 of the CSA of 1970 (21 U.S.C. 826), and delegated to the Administrator of the DEA by 28 CFR 0.100, and redelegated to the Deputy Administrator pursuant to 28 CFR 0.104, the Deputy Administrator hereby 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 (g)
1-Methyl-4-phenyl-4-propionoxypiperidine	2
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)	20
3,4-Methylenedioxy-N-ethylamphetamine (MDEA)	10
3,4-Methylenedioxymethamphetamine (MDMA)	20
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-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	3
Codeine-N-oxide	602
Diethyltryptamine	2
Difenoxin	3,000
Dihydromorphine	3,608,000
Dimethyltryptamine	3
Gamma-hydroxybutyric acid	3,000,000
Heroin	20
Hydromorphinol	2
Hydroxypethidine	2
Ibogaine	1
Lysergic acid diethylamide (LSD)	15
Marihuana	21,000
Mescaline	5
Methaqualone	7
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	16
Para-fluorofentanyl	2
Phenomorphan	2
Pholcodine	2
Psilocybin	2
Psilocyn	2
Tetrahydrocannabinols	264,000
Thiofentanyl	2
Tilidine	10
Trimeperidine	2

Basic Class—Schedule II	Proposed 2011 quotas (g)
1-Phenylcyclohexylamine	2
1-piperdinocyclohexanecarbonitrile	2
4-Anilino-N-phenethyl-4-piperidine (ANPP)	2,500,000
Alfentanil	8,000
Alphaprodine	2
Amobarbital	40,003
Amphetamine (for conversion)	7,500,000
Amphetamine (for sale)	18,600,000
Cocaine	247,000
Codeine (for conversion)	65,000,000
Codeine (for sale)	39,605,000
Dextropropoxyphene	92,000,000
Dihydrocodeine	800,000
Diphenoxylate	827,000
Ecgonine	83,000
Ethylmorphine	2
Fentanyl	1,428,000
Glutethimide	2
Hydrocodone (for sale)	55,000,000
Hydromorphone	3,455,000
Isomethadone	11
Levo-alphacetylmethadol (LAAM)	3
Levomethorphan	5
Levorphanol	10,000
Lisdexamfetamine	9,000,000
Meperidine	6,600,000
Meperidine Intermediate-A	3
Meperidine Intermediate-B	7
Meperidine Intermediate-C	3
Metazocine	1
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	50,000,000
Morphine (for conversion)	83,000,000
Morphine (for sale)	39,000,000
Nabilone	9,002
Noroxymorphone (for conversion)	9,000,000
Noroxymorphone (for sale)	41,000
Opium (powder)	230,000
Opium (tincture)	1,500,000
Oripavine	15,000,000
Oxycodone (for conversion)	5,600,000
Oxycodone (for sale)	105,500,000
Oxymorphone (for conversion)	12,800,000
Oxymorphone (for sale)	3,070,000
Pentobarbital	28,000,000
Phenazocine	1
Phencyclidine	14
Phenmetrazine	2
Phenylacetone	8,000,000
Racemethorphan	2
Remifentanil	2,500
Secobarbital	67,000
Sufentanil	7,000
Tapentadol	1,000,000
Thebaine	126,000,000

The Deputy Administrator further proposes that aggregate production quotas for all other schedules I and II controlled substances included in 21 CFR 1308.11 and 1308.12 be established at zero.

All interested persons are invited to submit their comments in writing or electronically regarding this proposal following the procedures in the addresses section of this document. A person may object to or comment on the proposal relating to any of the above-mentioned substances without filing comments or objections regarding the others. If a person believes that one or more of these issues warrant a hearing, the individual should so state and summarize the reasons for this belief.

In the event that comments or objections to this proposal raise one or more issues which the Deputy Administrator finds warrant a hearing, the Deputy Administrator shall order a public hearing by notice in the Federal Register, summarizing the issues to be heard and setting the time for the hearing.

The Office of Management and Budget has determined that notices of aggregate production quotas are not subject to centralized review under Executive Order 12866.

This action does not preempt or modify any provision of state law; nor does it impose enforcement responsibilities on any state; nor does it diminish the power of any state to enforce its own laws. Accordingly, this action does not have federalism implications warranting the application of Executive Order 13132.

The Deputy Administrator hereby certifies that this action will have no significant impact upon small entities whose interests must be considered under the Regulatory Flexibility Act, 5 U.S.C. 601 et seq. The establishment of aggregate production quotas for schedules I and II controlled substances is mandated by law and by international treaty obligations. The quotas are necessary to provide for the estimated medical, scientific, research and industrial needs of the United States, for export requirements and the establishment and maintenance of reserve stocks. While aggregate production quotas are of primary importance to large manufacturers, their impact upon small entities is neither negative nor beneficial. Accordingly, the Deputy Administrator has determined that this action does not require a regulatory flexibility analysis.

This action meets the applicable standards set forth in Sections 3(a) and 3(b)(2) of Executive Order 12988 Civil Justice Reform.

This action will not result in the expenditure by state, local, and tribal governments, in the aggregate, or by the private sector, of $129,400,000 or more in any one year, and will not significantly or uniquely affect small governments. Therefore, no actions were deemed necessary under the provisions of the Unfunded Mandates Reform Act of 1995.

This action is not a major rule as defined by Section 804 of the Small Business Regulatory Enforcement Fairness Act of 1996. This action will not result in an annual effect on the economy of $100,000,000 or more; a major increase in costs or prices; or significant adverse effects on competition, employment, investment, productivity, innovation, or on the ability of United States-based companies to compete with foreign-based companies in domestic and export markets.

Dated: September 3, 2010.

Michele M. Leonhart,

Deputy Administrator.