[Federal Register: December 3, 2004 (Volume 69, Number 232)]
[Notices]
[Page 70284-70287]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr03de04-81]
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA-259P]
Controlled Substances: Proposed Aggregate Production Quotas for
2005
AGENCY: Drug Enforcement Administration (DEA), Justice.
ACTION: Notice of proposed year 2005 aggregate production quotas.
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SUMMARY: This notice proposes initial year 2005 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 December
27, 2004.
ADDRESSES: To ensure proper handling of comments, please reference
``Docket No. DEA-259P'' 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 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 Section 0.100 of Title 28 of the Code of Federal
Regulations. The Administrator, in turn, has redelegated this function
to the Deputy Administrator, pursuant to Section 0.104 of Title 28 of
the Code of Federal Regulations.
The proposed year 2005 aggregate production quotas represent those
quantities of controlled substances that may be produced in the United
States in 2005 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 2005 aggregate production quotas,
the Deputy Administrator considered the following factors: total actual
2003 and estimated 2004 and 2005 net disposals of each substance by all
manufacturers; estimates of 2004 year-end inventories of each substance
and of any substance manufactured from it and trends in accumulation of
such inventories;
[[Page 70285]]
product development requirements of both bulk and finished dosage form
manufacturers; projected demand as indicated by procurement quota
applications filed pursuant to Section 1303.12 of Title 21 of the Code
of Federal Regulations; and other pertinent information.
Pursuant to Section 1303 of Title 21 of the Code of Federal
Regulations, the Deputy Administrator of the DEA will, in early 2005,
adjust aggregate production quotas and individual manufacturing quotas
allocated for the year based upon 2004 year-end inventory and actual
2004 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 Section 0.100 of Title 28 of the Code of
Federal Regulations, and redelegated to the Deputy Administrator
pursuant to Section 0.104 of Title 28 of the Code of Federal
Regulations, the Deputy Administrator hereby proposes that the year
2005 aggregate production quotas for the following controlled
substances, expressed in grams of anhydrous acid or base, be
established as follows:
------------------------------------------------------------------------
Proposed year
Basic class--Schedule I 2005 quotas
------------------------------------------------------------------------
2,5-Dimethoxyamphetamine................................ 2,801,000 g
2,5-Dimethoxy-4-ethylamphetamine (DOET)................. 2 g
2,5-Dimethoxy-4-(n)-propylthiophenethylamine............ 10 g
3-Methylfentanyl........................................ 2 g
3-Methylthiofentanyl.................................... 2 g
3,4-Methylenedioxyamphetamine(MDA)...................... 15 g
3,4-Methylenedioxy-N-ethylamphetamine (MDEA)............ 5 g
3,4-Methylenedioxymethamphetamine (MDMA)................ 15 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.................................... 2 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 (5-MeO-DIPT)........ 10 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........................................... 3 g
Alpha-methyltryptamine (AMT)............................ 10 g
Alpha-methylfentanyl.................................... 2 g
Alpha-methylthiofentanyl................................ 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.............................................. 2 g
Cathinone............................................... 2 g
Codeine-N-oxide......................................... 252 g
Diethyltryptamine....................................... 2 g
Difenoxin............................................... 5,000 g
Dihydromorphine......................................... 1,551,000 g
Dimethyltryptamine...................................... 3 g
Gamma-hydroxybutyric acid............................... 8,000,000 g
Heroin.................................................. 2 g
Hydromorphinol.......................................... 2 g
Hydroxypethidine........................................ 2 g
Lysergic acid diethylamide (LSD)........................ 60 g
Marihuana............................................... 840,020 g
Mescaline............................................... 2 g
Methaqualone............................................ 5 g
Methcathinone........................................... 4 g
Methyldihydromorphine................................... 2 g
Morphine-N-oxide........................................ 252 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
[[Page 70286]]
Normorphine............................................. 12 g
Para-fluorofentanyl..................................... 2 g
Phenomorphan............................................ 2 g
Pholcodine.............................................. 2 g
Propiram................................................ 50,000 g
Psilocybin.............................................. 2 g
Psilocyn................................................ 7 g
Tetrahydrocannabinols................................... 211,000 g
Thiofentanyl............................................ 2 g
Trimeperidine........................................... 2 g
------------------------------------------------------------------------
------------------------------------------------------------------------
Proposed year
Basic class--Schedule II 2005 quotas
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1-Phenylcyclohexylamine................................. 2 g
Alfentanil.............................................. 2,500 g
Alphaprodine............................................ 2 g
Amobarbital............................................. 2 g
Amphetamine............................................. 12,700,000 g
Cocaine................................................. 228,000 g
Codeine (for sale)...................................... 39,605,000 g
Codeine (for conversion)................................ 55,000,000 g
Dextropropoxyphene...................................... 167,365,000 g
Dihydrocodeine.......................................... 748,000 g
Diphenoxylate........................................... 571,000 g
Ecgonine................................................ 53,000 g
Ethylmorphine........................................... 2 g
Fentanyl................................................ 1,428,000 g
Glutethimide............................................ 2 g
Hydrocodone (for sale).................................. 37,604,000 g
Hydrocodone (for conversion)............................ g 1,500,000
Hydromorphone........................................... 1,951,000 g
Isomethadone............................................ 2 g
Levo-alphacetylmethadol (LAAM).......................... 2 g
Levomethorphan.......................................... 2 g
Levorphanol............................................. 5,000 g
Meperidine.............................................. 9,753,000 g
Metazocine.............................................. 1 g
Methadone (for sale).................................... 13,900,000 g
Methadone Intermediate.................................. 18,000,000 g
Methamphetamine......................................... 2,782,000 g
[680,000 grams of levo-desoxyephedrine for use in a non-controlled, non-
prescription product; 2,050,000 grams for methamphetamine mostly for
conversion to a Schedule III product; and 52,000 grams for
methamphetamine (for sale)]
Methylphenidate......................................... 30,817,000 g
Morphine (for sale)..................................... 35,000,000 g
Morphine (for conversion)............................... 110,774,000 g
Nabilone................................................ 2 g
Noroxymorphone (for sale)............................... 1,002 g
Noroxymorphone (for conversion)......................... 4,000,000 g
Opium................................................... 1,180,000 g
Oxycodone (for sale).................................... 49,200,000 g
Oxycodone (for conversion).............................. 920,000 g
Oxymorphone............................................. 534,000 g
Pentobarbital........................................... 18,251,000 g
Phencyclidine........................................... 2,006 g
Phenmetrazine........................................... 2 g
Racemethorphan.......................................... 2 g
Secobarbital............................................ 2 g
Sufentanil.............................................. 4,000 g
Thebaine................................................ 72,453,000 g
------------------------------------------------------------------------
The Deputy Administrator further proposes that aggregate production
quotas for all other Schedules I and II controlled substances included
in Sections 1308.11 and 1308.12 of Title 21 of the Code of Federal
Regulations 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
[[Page 70287]]
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
$114,000,000 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: November 30, 2004.
Michele M. Leonhart,
Deputy Administrator.
[FR Doc. 04-26689 Filed 12-2-04; 8:45 am]
BILLING CODE 4410-09-P