Controlled Substances: Established Initial Aggregate Production Quotas for 2011

DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[DEA #343E]

Controlled Substances: Established Initial Aggregate Production Quotas for 2011

AGENCY:

Drug Enforcement Administration (DEA), Justice.

ACTION:

Notice of aggregate production quotas for 2011.

SUMMARY:

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

DATES:

Effective Date:

December 20, 2010.

FOR FURTHER INFORMATION CONTACT:

Christine A. Sannerud, PhD, Chief, Drug & Chemical Evaluation Section, Drug Enforcement Administration, Springfield, Virginia 22152, Telephone: (202) 307-7183.

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 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 (21 U.S.C. 826(a) and 21 CFR 1303.11). These quotas do not include imports of controlled substances for use in industrial processes.

On September 15, 2010, a notice of the proposed initial 2011 aggregate production quotas for certain controlled substances in schedules I and II was published in the

Federal Register

(75 FR 56137). All interested persons were invited to comment on or object to these proposed aggregate production quotas on or before October 15, 2010.

Seven responses (six from DEA registered manufacturers, and one from a non-DEA registrant) were received within the published comment period, offering comments on a total of 31 schedules I and II controlled substances. The commenters stated that the proposed aggregate production quotas for 3,4-methylenedioxyamphetamine, 3,4-methylenedioxy-N-ethylamphetamine, 3,4-methylenedioxymethamphetamine, 4-anilino-N-phenethyl-4-piperidine, amphetamine (for sale), cathinone, codeine (for sale), dihydromorphine, fentanyl, gamma hydroxybutyric acid, heroin, hydrocodone, hydromorphone, marihuana, meperidine, methaqualone, methylphenidate, morphine (for conversion), morphine (for sale), nabilone, noroxymorphone (for conversion), opium (tincture), oxycodone (for sale), pentobarbital, phencyclidine, remifentanil, secobarbital, tapentadol, tetrahydrocannabinols, thebaine and tilidine were insufficient to provide for the estimated medical, scientific, research, and industrial needs of the United States, for export requirements and for the establishment and maintenance of reserve stocks.

In arriving at the aggregate production quotas, DEA has taken into consideration the above comments along with the factors set forth at 21 CFR 1303.11(b) and other relevant 2010 factors, including 2010 manufacturing quotas, current 2010 sales and inventories, 2011 export requirements, additional applications received, as well as research and product development requirements. Based on this information, DEA has adjusted the initial aggregate production quotas for 3,4-methylenedioxyamphetamine, 3,4-methylenedioxy-N-ethylamphetamine, 3,4-methylenedioxymethamphetamine, amobarbital, cathinone, dimethyltryptamine, ibogaine, lysergic

acid diethylamide, metazocine, methaqualone, nabilone, normorphine, noroxymorphone (for sale), phenazocine, phencyclidine, secobarbital, and tetrahydrocannabinols to meet the legitimate needs of the United States.

Regarding 4-anilino-N-phenethyl-4-piperidine, amphetamine (for sale), codeine (for sale), dihydromorphine, fentanyl, gamma hydroxybutyric acid, heroin, hydrocodone, hydromorphone, marihuana, meperidine, methylphenidate, morphine (for conversion), morphine (for sale), noroxymorphone (for conversion), opium (tincture), oxycodone (for sale), pentobarbital, remifentanil, tapentadol, thebaine and tilidine DEA has determined that the proposed initial 2011 aggregate production quotas are sufficient to meet the current 2011 estimated medical, scientific, research, and industrial needs of the United States.

Pursuant to 21 CFR 1303, the Deputy Administrator of DEA will, in 2011, adjust 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 schedule I or II controlled substance.

Therefore, under the authority vested in the Attorney General by Section 306 of the CSA (21 U.S.C. 826), and delegated to the Administrator of DEA by 28 CFR 0.100, and redelegated to the Deputy Administrator pursuant to 28 CFR 0.104, the Deputy Administrator hereby orders that the 2011 initial aggregate production quotas for the following controlled substances, expressed in grams of anhydrous acid or base, be established as follows:

Basic class—Schedule I

Established 2011 quotas

1-Methyl-4-phenyl-4-propionoxypiperidine

2 g

2,5-Dimethoxyamphetamine

2 g

2,5-Dimethoxy-4-ethylamphetamine (DOET)

2 g

2,5-Dimethoxy-4-n-propylthiophenethylamine

2 g

3-Methylfentanyl

2 g

3-Methylthiofentanyl

2 g

3,4-Methylenedioxyamphetamine (MDA)

22 g

3,4-Methylenedioxy-N-ethylamphetamine (MDEA)

15 g

3,4-Methylenedioxymethamphetamine (MDMA)

22 g

3,4,5-Trimethoxyamphetamine

2 g

4-Bromo-2,5-dimethoxyamphetamine (DOB)

2 g

4-Bromo-2,5-dimethoxyphenethylamine (2-CB)

2 g

4-Methoxyamphetamine

77 g

4-Methylaminorex

2 g

4-Methyl-2,5-dimethoxyamphetamine (DOM)

2 g

5-Methoxy-3,4-methylenedioxyamphetamine

2 g

5-Methoxy-N,N-diisopropyltryptamine

2 g

Acetyl-alpha-methylfentanyl

2 g

Acetyldihydrocodeine

2 g

Acetylmethadol

2 g

Allylprodine

2 g

Alphacetylmethadol

2 g

Alpha-ethyltryptamine

2 g

Alphameprodine

2 g

Alphamethadol

2 g

Alpha-methylfentanyl

2 g

Alpha-methylthiofentanyl

2 g

Alpha-methyltryptamine (AMT)

2 g

Aminorex

2 g

Benzylmorphine

2 g

Betacetylmethadol

2 g

Beta-hydroxy-3-methylfentanyl

2 g

Beta-hydroxyfentanyl

2 g

Betameprodine

2 g

Betamethadol

2 g

Betaprodine

2 g

Bufotenine

3 g

Cathinone

4 g

Codeine-N-oxide

602 g

Diethyltryptamine

2 g

Difenoxin

3,000 g

Dihydromorphine

3,608,000 g

Dimethyltryptamine

7 g

Gamma-hydroxybutyric acid

3,000,000 g

Heroin

20 g

Hydromorphinol

2 g

Hydroxypethidine

2 g

Ibogaine

5 g

Lysergic acid diethylamide (LSD)

16 g

Marihuana

21,000 g

Mescaline

5 g

Methaqualone

10 g

Methcathinone

4 g

Methyldihydromorphine

2 g

Morphine-N-oxide

605 g

N-Benzylpiperazine

2 g

N,N-Dimethylamphetamine

2 g

N-Ethylamphetamine

2 g

N-Hydroxy-3,4-methylenedioxyamphetamine

2 g

Noracymethadol

2 g

Norlevorphanol

52 g

Normethadone

2 g

Normorphine

18 g

Para-fluorofentanyl

2 g

Phenomorphan

2 g

Pholcodine

2 g

Psilocybin

2 g

Psilocyn

2 g

Tetrahydrocannabinols

393,000 g

Thiofentanyl

2 g

Tilidine

10 g

Trimeperidine

2 g

Basic class—Schedule II

Established 2011 quotas

1-Phenylcyclohexylamine

2 g

1-piperdinocyclohexanecarbonitrile

2 g

4-Anilino-N-phenethyl-4-piperidine (ANPP)

2,500,000 g

Alfentanil

8,000 g

Alphaprodine

2 g

Amobarbital

40,007 g

Amphetamine (for conversion)

7,500,000 g

Amphetamine (for sale)

18,600,000 g

Cocaine

247,000 g

Codeine (for conversion)

65,000,000 g

Codeine (for sale)

39,605,000 g

Dextropropoxyphene

92,000,000 g

Dihydrocodeine

800,000 g

Diphenoxylate

827,000 g

Ecgonine

83,000 g

Ethylmorphine

2 g

Fentanyl

1,428,000 g

Glutethimide

2 g

Hydrocodone (for sale)

55,000,000 g

Hydromorphone

3,455,000 g

Isomethadone

11 g

Levo-alphacetylmethadol (LAAM)

3 g

Levomethorphan

5 g

Levorphanol

10,000 g

Lisdexamfetamine

9,000,000 g

Meperidine

6,600,000 g

Meperidine Intermediate-A

3 g

Meperidine Intermediate-B

7 g

Meperidine Intermediate-C

3 g

Metazocine

5 g

Methadone (for sale)

20,000,000 g

Methadone Intermediate

26,000,000 g

Methamphetamine

3,130,000 g

[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

Morphine (for conversion)

83,000,000 g

Morphine (for sale)

39,000,000 g

Nabilone

10,502 g

Noroxymorphone (for conversion)

9,000,000 g

Noroxymorphone (for sale)

401,000 g

Opium (powder)

230,000 g

Opium (tincture)

1,500,000 g

Oripavine

15,000,000 g

Oxycodone (for conversion)

5,600,000 g

Oxycodone (for sale)

105,500,000 g

Oxymorphone (for conversion)

12,800,000 g

Oxymorphone (for sale)

3,070,000 g

Pentobarbital

28,000,000 g

Phenazocine

5 g

Phencyclidine

24 g

Phenmetrazine

2 g

Phenylacetone

8,000,000 g

Racemethorphan

2 g

Remifentanil

2,500 g

Secobarbital

260,002 g

Sufentanil

7,000 g

Tapentadol

1,000,000 g

Thebaine

126,000,000 g

The Deputy Administrator further orders 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.

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 $126,400,000 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: December 10, 2010.

Michele M. Leonhart,

Deputy Administrator.

[FR Doc. 2010-31849 Filed 12-17-10; 8:45 am]

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