[Federal Register: July 5, 2006 (Volume 71, Number 128)]
[Notices]
[Page 38174-38176]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr05jy06-74]
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA-270R]
Controlled Substances: Proposed Revised Aggregate Production
Quotas for 2006
AGENCY: Drug Enforcement Administration (DEA), U.S. Department of
Justice.
ACTION: Notice of proposed revised 2006 aggregate production quotas.
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SUMMARY: This notice proposes revised 2006 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 sent, on or before July 26, 2006.
ADDRESSES: To ensure proper handling of comments, please reference
``Docket No. DEA-270R 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/CCD. Written comments sent via express
mail should be sent to DEA Headquarters, Attention: DEA Federal
Register Representative/CCD, 2401 Jefferson-Davis Highway, Alexandria,
VA 22301. Comments may be directly sent to DEA electronically by
sending an electronic message to dea.diversion.policy@usdoj.gov.
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, Ph.D., Chief,
Drug and Chemical Evaluation Section, Drug Enforcement Administration,
Washington, DC 20537, 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.
On December 9, 2005, DEA published a notice of established initial
2006 aggregate production quotas for certain controlled substances in
Schedules I and II (70 FR 73269). This notice stipulated that the DEA
would adjust the quotas in early 2006 as provided for in 21 CFR part
1303.
The proposed revised 2006 aggregate production quotas represent
those quantities of controlled substances in Schedules I and II that
may be produced in the United States in 2006 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.
The proposed revisions are based on a review of 2005 year-end
inventories, 2005 disposition data submitted by quota applicants,
estimates of the medical needs of the United States, product
development, and other information available to the DEA.
Therefore, under the authority vested in the Attorney General by
section 306 of the CSA of 1970 (21 U.S.C. 826), 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 the following revised 2006 aggregate production quotas for the
following controlled substances, expressed in grams of anhydrous acid
or base:
------------------------------------------------------------------------
Previously
established Proposed
initial 2006 revised 2006
quotas (grams) quotas (grams)
------------------------------------------------------------------------
Basic Class--Schedule I:
2,5-Dimethoxyamphetamine............ 2,801,000 2,801,000
2,5-Dimethoxy-4-ethylamphetamine 2 2
(DOET).............................
3-Methylfentanyl.................... 2 2
3-Methylthiofentanyl................ 2 2
3,4-Methylenedioxyamphetamine (MDA). 20 20
3,4-Methylenedioxy-N- 10 10
ethylamphetamine (MDEA)............
3,4-Methylenedioxymethamphetamine 22 22
(MDMA).............................
3,4,5-Trimethoxyamphetamine......... 2 2
4-Bromo-2,5-dimethoxyamphetamine 2 2
(DOB)..............................
4-Bromo-2,5-dimethoxyphenethylamine 2 2
(2-CB).............................
4-Methoxyamphetamine................ 77 77
4-Methylaminorex.................... 2 2
[[Page 38175]]
4-Methyl-2,5-dimethoxyamphetamine 12 12
(DOM)..............................
5-Methoxy-3,4- 2 2
methylenedioxyamphetamine..........
Acetyl-alpha-methylfentanyl......... 2 2
Acetyldihydrocodeine................ 2 2
Acetylmethadol...................... 2 2
Allylprodine........................ 2 2
Alphacetylmethadol.................. 2 2
Alpha-ethyltryptamine............... 2 2
Alphameprodine...................... 2 2
Alphamethadol....................... 3 3
Alpha-methylfentanyl................ 2 2
Alpha-methylthiofentanyl............ 2 2
Aminorex............................ 2 2
Benzylmorphine...................... 2 2
Betacetylmethadol................... 2 2
Beta-hydroxy-3-methylfentanyl....... 2 2
Beta-hydroxyfentanyl................ 2 2
Betameprodine....................... 2 2
Betamethadol........................ 2 2
Betaprodine......................... 2 2
Bufotenine.......................... 5 5
Cathinone........................... 3 3
Codeine-N-oxide..................... 302 302
Diethyltryptamine................... 2 2
Difenoxin........................... 5,000 5,000
Dihydromorphine..................... 1,826,000 1,826,000
Dimethyltryptamine.................. 3 3
Gamma-hydroxybutyric acid........... 8,000,000 8,000,000
Heroin.............................. 5 5
Hydromorphinol...................... 2 2
Hydroxypethidine.................... 2 2
Lysergic acid diethylamide (LSD).... 61 61
Marihuana........................... 4,500,000 4,500,000
Mescaline........................... 2 2
Methaqualone........................ 10 10
Methcathinone....................... 4 4
Methyldihydromorphine............... 2 2
Morphine-N-oxide.................... 310 310
N,N-Dimethylamphetamine............. 2 2
N-Ethylamphetamine.................. 2 2
N-Hydroxy-3,4- 2 2
methylenedioxyamphetamine..........
Noracymethadol...................... 2 2
Norlevorphanol...................... 52 52
Normethadone........................ 2 2
Normorphine......................... 16 16
Para-fluorofentanyl................. 2 2
Phenomorphan........................ 2 2
Pholcodine.......................... 2 2
Psilocybin.......................... 7 7
Psilocyn............................ 7 7
Tetrahydrocannabinols............... 312,500 312,500
Thiofentanyl........................ 2 2
Trimeperidine....................... 2 2
Basic Class--Schedule II:
1-Phenylcyclohexylamine............. 2 2
Alfentanil.......................... 5,000 5,000
Alphaprodine........................ 2 2
Amobarbital......................... 101,000 101,000
Amphetamine......................... 17,000,000 17,000,000
Cocaine............................. 286,000 286,000
Codeine (for sale).................. 39,605,000 39,605,000
Codeine (for conversion)............ 55,000,000 55,000,000
Dextropropoxyphene.................. 167,365,000 167,365,000
Dihydrocodeine...................... 1,261,000 1,261,000
Diphenoxylate....................... 828,000 828,000
Ecgonine............................ 83,000 83,000
Ethylmorphine....................... 2 2
Fentanyl............................ 1,428,000 1,428,000
Glutethimide........................ 2 2
Hydrocodone (for sale).............. 41,252,000 41,252,000
Hydrocodone (for conversion)........ 1,500,000 1,500,000
[[Page 38176]]
Hydromorphone....................... 3,300,000 3,300,000
Isomethadone........................ 2 2
Levo-alphacetylmethadol (LAAM)...... 6 6
Levomethorphan...................... 5 5
Levorphanol......................... 5,000 5,000
Meperidine.......................... 9,753,000 9,753,000
Metazocine.......................... 1 1
Methadone (for sale)................ 21,000,000 25,000,000
Methadone Intermediate.............. 26,000,000 26,000,000
Methamphetamine..................... 3,130,000 3,130,000
[680,000 grams of levo-
desoxyephedrine for use in a non-
controlled, non-prescription
product; 2,405,000 grams for
methamphetamine mostly for
conversion to a Schedule III
product; and 45,000 grams for
methamphetamine (for sale)]
Methylphenidate..................... 35,000,000 35,000,000
Morphine (for sale)................. 35,000,000 35,000,000
Morphine (for conversion)........... 110,774,000 110,774,000
Nabilone............................ 2 2
Noroxymorphone (for sale)........... 1,002 1,002
Noroxymorphone (for conversion)..... 5,600,000 5,600,000
Opium............................... 1,280,000 1,280,000
Oxycodone (for sale)................ 49,200,000 49,200,000
Oxycodone (for conversion).......... 920,000 920,000
Oxymorphone......................... 534,000 534,000
Pentobarbital....................... 20,335,000 28,000,000
Phencyclidine....................... 2,021 2,021
Phenmetrazine....................... 2 2
Racemethorphan...................... 2 2
Remifentanil........................ 2,700 2,700
Secobarbital........................ 2 2
Sufentanil.......................... 6,500 6,500
Thebaine............................ 72,453,000 72,453,000
------------------------------------------------------------------------
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 remain 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 as per 21 CFR 1303.13(c).
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 not
have a 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
$118,000,000 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.
Dated: June 26, 2006.
Michele M. Leonhart,
Deputy Administrator.
[FR Doc. E6-10467 Filed 7-3-06; 8:45 am]
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