Controlled Substances: Proposed Adjustment to the Aggregate Production Quotas for 2012

DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. DEA-363]

Controlled Substances: Proposed Adjustment to the Aggregate Production Quotas for 2012

AGENCY:

Drug Enforcement Administration (DEA), Department of Justice.

ACTION:

Notice with request for comments.

SUMMARY:

This notice proposes to adjust the 2012 aggregate production quotas for several 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 August 6, 2012. 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-363” 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

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:

John W. Partridge, Chief, Liaison and Policy Section, Drug Enforcement Administration, 8701 Morrissette Drive, Springfield, VA 22152, Telephone: (202) 307-4654.

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 Administrator, in turn, has redelegated this function to the Deputy Administrator, pursuant to 28 CFR 0.104. The 2012 established aggregate production quotas for controlled substances in schedules I and II were published in the

Federal Register

(76 FR 78044) on December 15, 2011. That notice stipulated that, as provided for in 21 CFR 1303.13, all aggregate production quotas are subject to adjustment.

Analysis for Proposed Revised 2012 Aggregate Production Quotas

DEA now proposes to adjust the established 2012 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 of the United States and lawful export requirements, as the Administrator finds relevant.

In determining whether to propose adjustments to the 2012 aggregate production quotas, DEA considered updated information obtained from 2011 year-end inventories, 2011 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 Deputy Administrator, therefore, proposes to adjust the 2012 aggregate production quotas for some schedule I and II controlled substances, expressed in grams of anhydrous acid or base, as follows:

Basic class

Previously

established 2012 quotas

Proposed

adjusted 2012 quotas

Schedule I

1-[1-(2-Thienyl)cyclohexyl]piperidine

0 g

5 g.

1-[2-(4-Morpholinyl)ethyl]-3-(1-naphthoyl)indole (JWH-200)

45 g

No Change.

1-Butyl-3-(1-naphthoyl)indole (JWH-073)

45 g

No Change.

1-Methyl-4-phenyl-4-propionoxypiperidine

2 g

No Change.

1-Pentyl-3-(1-naphthoyl)indole (JWH-018)

45 g

No Change.

2,5-Dimethoxyamphetamine

2 g

12 g.

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

2 g

12 g.

2,5-Dimethoxy-4-n-propylthiophenethylamine

2 g

12 g.

3-Methylfentanyl

2 g

No Change.

3-Methylthiofentanyl

2 g

No Change.

3,4-Methylenedioxyamphetamine (MDA)

22 g

30 g.

3,4-Methylenedioxy-N-methylcathinone (methylone)

8 g

12 g.

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

15 g

24 g.

3,4-Methylenedioxymethamphetamine (MDMA)

22 g

30 g.

3,4-Methylenedioxypyrovalerone (MDPV)

8 g

12 g.

3,4,5-Trimethoxyamphetamine

2 g

12 g.

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

2 g

12 g.

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

2 g

12 g.

4-Methoxyamphetamine

77 g

88 g.

4-Methylaminorex

2 g

12 g.

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

2 g

12 g.

4-Methyl-N-methylcathinone (mephedrone)

8 g

12 g.

5-(1,1-Dimethylheptyl)-2-[(1R,3S)-3-hydroxycyclohexyl]-phenol

68 g

No Change.

5-(1,1-Dimethyloctyl)-2-[(1R,3S)-3-hydroxycyclohexyl]-phenol

53 g

No Change.

5-Methoxy-3,4-methylenedioxyamphetamine

2 g

12 g.

5-Methoxy-N,N-diisopropyltryptamine

2 g

12 g.

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

12 g.

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

12 g.

Aminorex

2 g

12 g.

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

12 g.

Codeine-N-oxide

602 g

No Change.

Diethyltryptamine

2 g

12 g.

Difenoxin

50 g

No Change.

Dihydromorphine

3,608,000 g

No Change.

Dimethyltryptamine

7 g

18 g.

Gamma-hydroxybutyric acid

47,000,000 g

No Change.

Heroin

20 g

No Change.

Hydromorphinol

54 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

13 g.

Methaqualone

10 g

No Change.

Methcathinone

4 g

12 g.

Methyldihydromorphine

2 g

No Change.

Morphine-N-oxide

655 g

No Change.

N-Benzylpiperazine

2 g

12 g.

N,N-Dimethylamphetamine

2 g

12 g.

N-Ethylamphetamine

2 g

12 g.

N-Hydroxy-3,4-methylenedioxyamphetamine

2 g

12 g.

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.

Properidine

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.

Schedule II

1-Phenylcyclohexylamine

2 g

No Change.

1-Piperdinocyclohexanecarbonitrile

2 g

27 g.

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

1,800,000 g

No Change.

Alfentanil

15,000 g

19,550 g.

Alphaprodine

2 g

No Change.

Amobarbital

40,007 g

No Change.

Amphetamine (for conversion)

8,500,000 g

Amphetamine (for sale) *

25,300,000 g

33,400,000 g.

* DEA has determined that the revised total quantity to provide for the estimated medical, scientific, research, and industrial needs of the United States, lawful export requirements, and the establishment and maintenance of reserve stock is 29,400,000 g. DEA has further determined that an additional 4,000,000 g is necessary to provide for future research and development needs and unexpected emergencies that could affect market availability.

Carfentanil

0 g

5 g.

Cocaine

216,000 g

No Change.

Codeine (for conversion)

65,000,000 g

No Change.

Codeine (for sale)

39,605,000 g

No Change.

Dextropropoxyphene

7 g

No Change.

Dihydrocodeine

400,000 g

No Change.

Diphenoxylate

900,000 g

No Change.

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)

59,000,000 g

63,000,000 g.

Hydromorphone

3,455,000 g

3,628,000 g.

Isomethadone

4 g

No Change.

Levo-alphacetylmethadol (LAAM)

3 g

No Change.

Levomethorphan

5 g

No Change.

Levorphanol

3,600 g

No Change.

Lisdexamfetamine

12,000,000 g

No Change.

Meperidine

5,500,000 g

No Change.

Meperidine Intermediate-A

5 g

No Change.

Meperidine Intermediate-B

9 g

No Change.

Meperidine Intermediate-C

5 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

56,000,000 g

No Change.

Morphine (for conversion)

83,000,000 g

No Change.

Morphine (for sale)

39,000,000 g

No Change.

Nabilone

20,502 g

No Change.

Noroxymorphone (for conversion)

7,200,000 g

No Change.

Noroxymorphone (for sale)

401,000 g

1,981,000 g.

Opium (powder)

63,000 g

73,000 g.

Opium (tincture)

1,000,000 g

No Change.

Oripavine

9,800,000 g

15,300,000 g.

Oxycodone (for conversion)

5,600,000 g

No Change.

Oxycodone (for sale)

98,000,000 g

98,700,000 g.

Oxymorphone (for conversion)

12,800,000 g

No Change.

Oxymorphone (for sale)

5,500,000 g

No Change.

Pentobarbital

34,000,000 g

No Change.

Phenazocine

5 g

No Change.

Phencyclidine

24 g

No Change.

Phenmetrazine

2 g

No Change.

Phenylacetone

16,000,000 g

No Change.

Racemethorphan

2 g

No Change.

Remifentanil

2,500 g

No Change.

Secobarbital

336,002 g

No Change.

Sufentanil

5,000 g

No Change.

Tapentadol

5,400,000 g

No Change.

Thebaine

116,000,000 g

No Change.

Aggregate production quotas for all other schedule I and II controlled substances included in 21 CFR 1308.11 and 1308.12 remain at zero. Pursuant to 21 CFR part 1303, the Deputy Administrator may adjust the 2012 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 Deputy Administrator may hold a public hearing on one or more issues raised. In the event the Deputy Administrator decides in his sole discretion to hold such a hearing, the Deputy 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 Deputy Administrator will publish in the

Federal Register

a Final

Order determining any adjustment of the aggregate production quota.

Dated: June 28, 2012.

Michele M. Leonhart,

Administrator.

[FR Doc. 2012-16396 Filed 7-3-12; 8:45 am]

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