[Federal Register Volume 76, Number 178 (Wednesday, September 14, 2011)]
[Notices]
[Pages 56810-56814]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-23498]
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA-343R]
Controlled Substances: 2011 Proposed Aggregate Production Quotas
AGENCY: Drug Enforcement Administration (DEA), Department of Justice.
ACTION: Notice with request for comments.
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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
[[Page 56811]]
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: (202) 307-7184.
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:
[[Page 56812]]
------------------------------------------------------------------------
Previously
established Proposed adjusted
Basic class-schedule I initial 2011 2011 quotas
quotas
------------------------------------------------------------------------
1-Methyl-4-phenyl-4- 2 g No Change.
propionoxypiperidine.
2,5-Dimethoxyamphetamine........... 2 g No Change.
2,5-Dimethoxy-4-ethylamphetamine 2 g No Change.
(DOET).
2,5-Dimethoxy-4-n- 2 g No Change.
propylthiophenethylamine.
3-Methylfentanyl................... 2 g No Change.
3-Methylthiofentanyl............... 2 g No Change.
3,4-Methylenedioxyamphetamine (MDA) 22 g No Change.
3,4-Methylenedioxy-N- 15 g No Change.
ethylamphetamine (MDEA).
3,4-Methylenedioxymethamphetamine 22 g No Change.
(MDMA).
3,4,5-Trimethoxyamphetamine........ 2 g No Change.
4-Bromo-2,5-dimethoxyamphetamine 2 g No Change.
(DOB).
4-Bromo-2,5-dimethoxyphenethylamine 2 g No Change.
(2-CB).
4-Methoxyamphetamine............... 77 g No Change.
4-Methylaminorex................... 2 g No Change.
4-Methyl-2,5-dimethoxyamphetamine 2 g No Change.
(DOM).
5-Methoxy-3,4- 2 g No Change.
methylenedioxyamphetamine.
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- 2 g No Change.
methylenedioxyamphetamine.
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.
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[[Page 56813]]
------------------------------------------------------------------------
Previously
established Proposed adjusted
Basic class--schedule II initial 2011 2011 quotas
quotas
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1-Phenylcyclohexylamine............ 2 g No Change.
1-Piperdinocyclohexanecarbonitrile. 2 g No Change.
4-Anilino-N-phenethyl-4-piperidine 2,500,000 g 1,800,000 g.
(ANPP).
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
[[Page 56814]]
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- 45 g
naphthoyl)indole (JWH-200).
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- 68 g
hydroxycyclohexyl]-phenol (CP-47,497).
5-(1,1-Dimethyloctyl)-2-[(1R,3S)-3- 53 g
hydroxycyclohexyl]-phenol
(cannabicyclohexanol; CP-47,497 C8
homologue).
------------------------------------------------------------------------
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.
[FR Doc. 2011-23498 Filed 9-13-11; 8:45 am]
BILLING CODE 4410-09-P