E7-16729. Controlled Substances: Proposed Aggregate Production Quotas for 2008

AGENCY:

Drug Enforcement Administration (DEA), Justice.

ACTION:

Notice of proposed year 2008 aggregate production quotas.

SUMMARY:

This notice proposes initial year 2008 aggregate production quotas for controlled substances in schedules I and II of the Controlled Substances Act (CSA).

DATES:

Comments or objections must be received on or before September 14, 2007.

ADDRESSES:

To ensure proper handling of comments, please reference “Docket No. DEA-307P” on all written and electronic correspondence. Written comments being sent via regular mail should be sent to the Deputy Assistant Administrator, Office of Diversion Control, Drug Enforcement Administration, Washington, DC 20537, Attention: DEA Federal Register Representative/ODL. Written comments sent via express mail should be sent to DEA Headquarters, Attention: DEA Federal Register Representative/ODL, 2401 Jefferson Davis Highway, Alexandria, VA 22301. Comments may be directly sent to DEA electronically by sending an electronic message to [e-mail]. Comments may also be sent 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. 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.

FOR FURTHER INFORMATION CONTACT:

Christine A. Sannerud, PhD, Chief, Drug and Chemical Evaluation Section, Drug Enforcement Administration, Washington, DC 20537, Telephone: [phone].

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 2008 aggregate production quotas represent those quantities of controlled substances that may be produced in the United States in 2008 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 year 2008 aggregate production quotas, the Deputy Administrator considered the following factors: Total actual 2006 and estimated 2007 and 2008 net disposals of each substance by all manufacturers; estimates of 2007 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, in early 2008, adjust aggregate production quotas and individual manufacturing quotas allocated for the year based upon 2007 year-end inventory and actual 2007 disposition data supplied by quota recipients for each basic class of schedule I or II controlled substance.

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 2008 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 year 2008 quotas (grams)
2,5-Dimethoxyamphetamine	2
2,5-Dimethoxy-4-ethylamphetamine (DOET)	2
2,5-Dimethoxy-4-(n)-propylthiophenethylamine (2C-T-7)	10
3-Methylfentanyl	2
3-Methylthiofentanyl	2
3,4-Methylenedioxyamphetamine (MDA)	20
3,4-Methylenedioxy-N-ethylamphetamine (MDEA)	10
3,4-Methylenedioxymethamphetamine (MDMA)	22
3,4,5-Trimethoxyamphetamine	2
4-Bromo-2,5-dimethoxyamphetamine (DOB)	2
4-Bromo-2,5-dimethoxyphenethylamine (2-CB)	7
4-Methoxyamphetamine	77
4-Methylaminorex	2
4-Methyl-2,5-dimethoxyamphetamine (DOM)	12
5-Methoxy-3,4-methylenedioxyamphetamine	2
5-Methoxy-N,N-diisopropyltryptamine	5
Acetyl-alpha-methylfentanyl	2
Acetyldihydrocodeine	2
Acetylmethadol	2
Allylprodine	2
Alphacetylmethadol	2
Alpha-ethyltryptamine	2
Alphameprodine	2
Alphamethadol	3
Alpha-methylfentanyl	2
Alpha-methylthiofentanyl	2
Alpha-methyltryptamine	5
Aminorex	8
Benzylmorphine	2
Betacetylmethadol	2
Beta-hydroxy-3-methylfentanyl	2
Beta-hydroxyfentanyl	2
Betameprodine	2
Betamethadol	2
Betaprodine	2
Bufotenine	8
Cathinone	3
Codeine-N-oxide	302
Diethyltryptamine	2
Difenoxin	50
Dihydromorphine	2,549,000
Dimethyltryptamine	3
Gamma-hydroxybutyric acid	23,600,000
Heroin	5
Hydromorphinol	3,000
Hydroxypethidine	2
Ibogaine	1
Lysergic acid diethylamide (LSD)	61
Marihuana	4,500,000
Mescaline	2
Methaqualone	10
Methcathinone	4
Methyldihydromorphine	2
Morphine-N-oxide	310
N,N-Dimethylamphetamine	7
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	7
Psilocyn	7
Tetrahydrocannabinols	312,500
Thiofentanyl	2
Trimeperidine	2
1-Phenylcyclohexylamine	2
Alfentanil	5,200
Alphaprodine	2
Amobarbital	3
Amphetamine (for sale)	17,000,000
Amphetamine (for conversion)	5,000,000
Cocaine	286,000
Codeine (for sale)	39,605,000
Codeine (for conversion)	59,000,000
Dextropropoxyphene	106,000,000
Dihydrocodeine	1,200,000
Diphenoxylate	828,000
Ecgonine	83,000
Ethylmorphine	2
Fentanyl	1,428,000
Glutethimide	2
Hydrocodone (for sale)	46,000,000
Hydrocodone (for conversion)	1,500,000
Hydromorphone	3,300,000
Isomethadone	2
Levo-alphacetylmethadol (LAAM)	3
Levomethorphan	5
Levorphanol	6,000
Lisdexamfetamine	6,200,000
Meperidine	9,753,000
Metazocine	1
Methadone (for sale)	25,000,000
Methadone Intermediate	26,000,000
Methamphetamine	3,130,000
Methylphenidate	50,000,000
Morphine (for sale)	35,000,000
Morphine (for conversion)	100,000,000
Nabilone	3,002
Noroxymorphone (for sale)	1,002
Noroxymorphone (for conversion)	8,000,000
Opium	1,400,000
Oxycodone (for sale)	70,000,000
Oxycodone (for conversion)	3,100,000
Oxymorphone	1,800,000
Oxymorphone (for conversion)	11,000,000
Pentobarbital	35,200,000
Phencyclidine	2,021
Phenmetrazine	2
Racemethorphan	2
Remifentanil	3,000
Secobarbital	2
Sufentanil	10,300
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 $120,000,000 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.

August 15, 2007.

Michele M. Leonhart,

Deputy Administrator.