[Federal Register: September 9, 2004 (Volume 69, Number 174)]
[Notices]
[Page 54703-54705]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr09se04-126]
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA-249R]
Controlled Substances: Proposed Revised Aggregate Production
Quotas for 2004
AGENCY: Drug Enforcement Administration (DEA), Justice.
ACTION: Notice of proposed revised 2004 aggregate production quotas.
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SUMMARY: This notice proposes revised 2004 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 September 30, 2004.
ADDRESSES: To ensure proper handling of comments, please reference
``Docket No. DEA-249'' 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 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 Sec. 0.104 of Title 28 of the
Code of Federal Regulations.
On December 15, 2003, DEA published a notice of established initial
2004 aggregate production quotas for certain controlled substances in
Schedules I and II (68 FR 69720). This notice stipulated that the DEA
would adjust the quotas in early 2004 as provided for in Part 1303 of
Title 21 of the Code of Federal Regulations.
The proposed revised 2004 aggregate production quotas represent
those quantities of controlled substances in Schedules I and II that
may be produced in the United States in 2004 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 2003 year-end
inventories, 2003 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 Sec. 0.100 of Title 28 of the Code of
Federal Regulations, and redelegated to the Deputy Administrator
pursuant to Sec. 0.104 of Title 28 of the Code of Federal Regulations,
the Deputy Administrator hereby proposes the following revised 2004
aggregate production quotas for the following controlled substances,
expressed in grams of anhydrous acid or base:
------------------------------------------------------------------------
Previously
established Proposed revised
Basic class initial 2004 2004 quotas
quotas
------------------------------------------------------------------------
Schedule I
------------------------------------------------------------------------
2,5-Dimethoxyamphetamine.......... 3,501,000 3,501,000
2,5-Dimethoxy-4-ethylamphetamine 2 2
(DOET)...........................
2,5-Dimethoxy-4-n- 10 10
propylthiophenethylamine (2C-T-7)
3-Methylfentanyl.................. 2 2
3-Methylthiofentanyl.............. 2 2
3,4-Methylenedioxyamphetamine 11 11
(MDA)............................
3,4-Methylenedioxy-N- 5 5
ethylamphetamine (MDEA)..........
3,4-Methylenedioxymethamphetamine 16 16
(MDMA)...........................
3,4,5-Trimethoxyamphetamine....... 2 2
4-Bromo-2,5-Dimethoxyamphetamine 2 2
(DOB)............................
4-Bromo-2,5- 2 2
Dimethoxyphenethylamine (2-CB)...
4-Methoxyamphetamine.............. 2 2
4-Methylaminorex.................. 2 2
4-Methyl-2,5-Dimethoxyamphetamine 2 2
(DOM)............................
5-Methyoxy-3,4- 2 2
Methylenedioxyamphetamine........
5-Methoxy-N,N- 10 10
diisopropyltryptamine (5-MeO-
DIPT)............................
Acetyl-alpha-methylfentanyl....... 2 2
Acetyldihydrocodeine.............. 2 2
Acetylmethadol.................... 2 2
Allylprodine...................... 4 4
[[Page 54704]]
Alphacetylmethadol................ 2 2
Alpha-ethyltryptamine............. 2 2
Alphameprodine.................... 2 2
Alphamethadol..................... 3 3
Alpha-methyltryptamine (AMT)...... 10 10
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........................ 2 2
Cathinone......................... 2 2
Codeine-N-oxide................... 502 502
Diethyltryptamine................. 2 2
Difenoxin......................... 9,000 8,000
Dihydromorphine................... 1,101,000 1,101,000
Dimethyltryptamine................ 3 3
Gamma-hydroxybutyric acid......... 10,000,000 8,000,000
Heroin............................ 5 5
Hydromorphinol.................... 2 2
Hydroxypethidine.................. 2 2
Lysergic acid diethylamide (LSD).. 61 61
Marihuana......................... 840,000 840,020
Mescaline......................... 2 2
Methaqualone...................... 5 5
Methcathinone..................... 4 4
Methyldihydromorphine............. 2 2
Morphine-N-oxide.................. 502 502
N,N-Dimethylamphetamine........... 2 2
N-Ethyl-1-Phenylcyclohexylamine 5 5
(PCE)............................
N-Ethylamphetamine................ 7 7
N-Hydroxy-3,4- 2 2
Methylenedioxyamphetamine........
Noracymethadol.................... 2 2
Norlevorphanol.................... 52 52
Normethadone...................... 2 2
Normorphine....................... 12 12
Para-fluorofentanyl............... 2 2
Phenomorphan...................... 2 2
Pholcodine........................ 2 2
Propiram.......................... 210,000 210,000
Psilocybin........................ 2 2
Psilocyn.......................... 2 2
Tetrahydrocannabinols............. 176,000 176,000
Thiofentanyl...................... 2 2
Trimeperidine..................... 2 2
-----------------------------------
Schedule II
------------------------------------------------------------------------
1-Phenylcyclohexylamine........... 2 2
1- 10 10
Piperidinocyclohexanecarbonitrile
(PCC)............................
Alfentanil........................ 2,000 2,000
Alphaprodine...................... 2 2
Amobarbital....................... 3 3
Amphetamine....................... 10,987,000 12,700,000
Cocaine........................... 186,000 200,000
Codeine (for sale)................ 41,341,000 41,341,000
Codeine (for conversion).......... 43,559,000 48,000,000
Dextropropoxyphene................ 167,365,000 167,365,000
Dihydrocodeine.................... 776,000 776,000
Diphenoxylate..................... 716,000 836,000
Ecgonine.......................... 38,000 38,000
Ethylmorphine..................... 2 2
Fentanyl.......................... 970,000 1,225,000
Glutethimide...................... 2 2
Hydrocodone (for sale)............ 30,622,000 34,000,000
Hydrocodone (for conversion)...... 1,500,000 1,500,000
Hydromorphone..................... 1,651,000 1,651,000
[[Page 54705]]
Isomethadone...................... 2 2
Levo-alphacetylmethadol (LAAM).... 2 2
Levomethorphan.................... 2 2
Levorphanol....................... 15,000 15,000
Meperidine........................ 9,753,000 9,753,000
Metazocine........................ 1 1
Methadone (for sale).............. 14,057,000 14,720,000
Methadone Intermediate............ 18,296,000 18,296,000
Methamphetamine................... 2,275,000 2,180,000
[675,000 grams of levo-desoxyephedrine for use in a non-controlled,
non-prescription product; 1,475,000 grams for methamphetamine mostly
for conversion to a Schedule III product; and 30,000 grams for
methamphetamine (for sale)]
Methylphenidate................... 23,726,000 27,428,000
Morphine (for sale)............... 21,800,000 25,000,000
Morphine (for conversion)......... 110,774,000 110,774,000
Nabilone.......................... 2 2
Noroxymorphone (for sale)......... 99,000 99,000
Noroxymorphone (for conversion)... 3,800,000 3,800,000
Opium............................. 1,000,000 1,300,000
Oxycodone (for sale).............. 41,606,000 49,200,000
Oxycodone (for conversion)........ 920,000 920,000
Oxymorphone....................... 534,000 534,000
Pentobarbital..................... 18,251,000 18,251,000
Phencyclidine..................... 2,060 2,060
Phenmetrazine..................... 2 2
Phenylacetone..................... 11,000,000 11,000,000
Racemethorphan.................... 2 2
Secobarbital...................... 1,000 2
Sufentanil........................ 4,000 4,000
Thebaine.......................... 59,437,000 72,400,000
------------------------------------------------------------------------
The Deputy Administrator further proposes that aggregate production
quotas for all other Schedules I and II controlled substances included
in Sec. 1308.11 and 1308.12 of Title 21 of the Code of Federal
Regulations 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) and 1303.32.
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
$113,000,000 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: September 1, 2004.
Michele M. Leonhart,
Deputy Administrator.
[FR Doc. 04-20369 Filed 9-8-04; 8:45 am]
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