[Federal Register: October 21, 2005 (Volume 70, Number 203)]
[Notices]
[Page 61310-61313]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr21oc05-114]
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA-270P]
Controlled Substances: Proposed Aggregate Production Quotas for
2006
AGENCY: Drug Enforcement Administration (DEA), Justice.
ACTION: Notice of proposed year 2006 aggregate production quotas.
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SUMMARY: This notice proposes initial year 2006 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 November
14, 2005.
ADDRESSES: To ensure proper handling of comments, please reference
``Docket No. DEA-270P'' 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 2006 aggregate production quotas represent those
quantities of controlled substances 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
[[Page 61311]]
include imports of controlled substances for use in industrial
processes.
In determining the proposed year 2006 aggregate production quotas,
the Deputy Administrator considered the following factors: Total actual
2004 and estimated 2005 and 2006 net disposals of each substance by all
manufacturers; estimates of 2005 year-end inventories of each substance
and of any substance manufactured from it and trends in accumulation of
such inventories; 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 2006,
adjust aggregate production quotas and individual manufacturing quotas
allocated for the year based upon 2005 year-end inventory and actual
2005 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
2006 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 year 2006 quotas
------------------------------------------------------------------------
2,5-Dimethoxyamphetamine..................... 2,801,000 g
2,5-Dimethoxy-4-ethylamphetamine (DOET)...... 2 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)..... 17 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......................... 5 g
4-Methylaminorex............................. 2 g
4-Methyl-2,5-dimethoxyamphetamine (DOM)...... 2 g
5-Methoxy-3,4-methylenedioxyamphetamine...... 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................................ 3 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.............................. 1,826,000 g
Dimethyltryptamine........................... 3 g
Gamma-hydroxybutyric acid.................... 8,000,000 g
Heroin....................................... 2 g
Hydromorphinol............................... 2 g
Hydroxypethidine............................. 2 g
Lysergic acid diethylamide (LSD)............. 61 g
Marihuana.................................... 4,500,000 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
[[Page 61312]]
Normethadone................................. 2 g
Normorphine.................................. 12 g
Para-fluorofentanyl.......................... 2 g
Phenomorphan................................. 2 g
Pholcodine................................... 2 g
Psilocybin................................... 2 g
Psilocyn..................................... 7 g
Tetrahydrocannabinols........................ 312,500 g
Thiofentanyl................................. 2 g
Trimeperidine................................ 2 g
------------------------------------------------------------------------
------------------------------------------------------------------------
Basic class--schedule II Proposed year 2006 quotas
------------------------------------------------------------------------
1-Phenylcyclohexylamine...................... 2 g
Alfentanil................................... 2,500 g
Alphaprodine................................. 2 g
Amobarbital.................................. 2 g
Amphetamine.................................. 14,500,000 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............................... 750,000 g
Diphenoxylate................................ 828,000 g
Ecgonine..................................... 73,000 g
Ethylmorphine................................ 2 g
Fentanyl..................................... 1,428,000 g
Glutethimide................................. 2 g
Hydrocodone (for sale)....................... 37,604,000 g
Hydrocodone (for conversion)................. 1,500,000 g
Hydromorphone................................ 3,300,000 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)......................... 15,490,000 g
Methadone Intermediate....................... 19,208,000 g
Methamphetamine.............................. 2,340,000 g
[680,000 grams of levo-desoxyephedrine for use in a non-controlled,
non-prescription product; 1,615,000 grams for methamphetamine
mostly for conversion to a Schedule III product; and 45,000 grams
for methamphetamine (for sale)]
Methylphenidate.............................. 35,000,000 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........................................ 1,280,000 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
Remifentanil................................. 1,800 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.
[[Page 61313]]
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.
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
$115,000,000 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: October 14, 2005.
Michele M. Leonhart,
Deputy Administrator.
[FR Doc. 05-21038 Filed 10-20-05; 8:45 am]
BILLING CODE 4410-09-P