[Federal Register: May 3, 2007 (Volume 72, Number 85)]
[Notices]
[Page 24608-24611]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr03my07-83]
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA-290R]
Controlled Substances: Proposed Revised Aggregate Production
Quotas for 2007
AGENCY: Drug Enforcement Administration (DEA), Justice.
ACTION: Notice of proposed revised 2007 aggregate production quotas.
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SUMMARY: This notice proposes revised 2007 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 May 24, 2007.
ADDRESSES: To ensure proper handling of comments, please reference
``Docket No. DEA-290R 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
[[Page 24609]]
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, PhD, 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 11, 2006, a notice of established initial 2007
aggregate production quotas for certain controlled substances in
schedules I and II was published in the Federal Register (71 FR 71559).
This notice stipulated that the DEA would adjust the quotas in early
2007 as provided for in 21 CFR Part 1303.
The proposed revised 2007 aggregate production quotas represent
those quantities of controlled substances in schedules I and II that
may be produced in the United States in 2007 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 2006 year-end
inventories, 2006 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 (21 U.S.C. 826), and 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 2007 aggregate production quotas for the
following controlled substances, expressed in grams of anhydrous acid
or base:
------------------------------------------------------------------------
Previously
Basic class--Schedule I established initial Proposed revised
2007 quotas 2007 quotas
------------------------------------------------------------------------
2,5-Dimethoxyamphetamine.... 2,001,000 g 2,001,000 g
2,5-Dimethoxy-4- 2 2
ethylamphetamine (DOET)....
2,5-Dimethoxy-4-(n)- 10 10
propylthiophenethylamine
(2C-T-7)...................
3-Methylfentanyl............ 2 2
3-Methylthiofentanyl........ 2 2
3,4-Methylenedioxyamphetamin 20 20
e (MDA)....................
3,4-Methylenedioxy-N- 10 10
ethylamphetamine (MDEA)....
3,4-Methylenedioxymethamphet 22 22
amine (MDMA)...............
3,4,5-Trimethoxyamphetamine. 2 2
4-Bromo-2,5- 2 2
dimethoxyamphetamine (DOB).
4-Bromo-2,5- 7 2
dimethoxyphenethylamine (2-
CB)........................
4-Methoxyamphetamine........ 77 77
4-Methylaminorex............ 2 2
4-Methyl-2,5- 12 12
dimethoxyamphetamine (DOM).
5-Methoxy-3,4- 2 2
methylenedioxyamphetamine..
5-Methoxy-N,N- 5 5
diisopropyltryptamine......
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
Alpha-methyltryptamine...... 5 5
Aminorex.................... 8 8
Benzylmorphine.............. 2 2
Betacetylmethadol........... 2 2
Beta-hydroxy-3- 2 2
methylfentanyl.............
Beta-hydroxyfentanyl........ 2 2
Betameprodine............... 2 2
Betamethadol................ 2 2
Betaprodine................. 2 2
Bufotenine.................. 8 8
Cathinone................... 3 3
Codeine-N-oxide............. 302 302
Diethyltryptamine........... 2 2
Difenoxin................... 50 50
Dihydromorphine............. 2,549,000 2,549,000
Dimethyltryptamine.......... 3 3
Gamma-hydroxybutyric acid... 13,100,000 13,100,000
Heroin...................... 5 5
Hydromorphinol.............. 3,000 3,000
Hydroxypethidine............ 2 2
Ibogaine.................... 1 1
[[Page 24610]]
Lysergic acid diethylamide 61 61
(LSD)......................
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..... 7 7
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
------------------------------------------------------------------------
------------------------------------------------------------------------
Previously
Basic class--Schedule II established initial Proposed revised
2007 quotas 2007 quotas
------------------------------------------------------------------------
1-Phenylcyclohexylamine..... 2 g 2 g
Alfentanil.................. 7,200 7,200
Alphaprodine................ 2 2
Amobarbital................. 3 3
Amphetamine (for sale)...... 17,000,000 17,000,000
Amphetamine (for conversion) 0 2,760,000
Cocaine..................... 286,000 286,000
Codeine (for sale).......... 39,605,000 39,605,000
Codeine (for conversion).... 59,000,000 59,000,000
Dextropropoxyphene.......... 120,000,000 120,000,000
Dihydrocodeine.............. 2,435,000 2,435,000
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)...... 42,000,000 42,000,000
Hydrocodone (for conversion) 1,500,000 1,500,000
Hydromorphone............... 3,300,000 3,300,000
Isomethadone................ 2 2
Levo-alphacetylmethadol 6 6
(LAAM).....................
Levomethorphan.............. 5 5
Levorphanol................. 6,000 6,000
Lisdexamfetamine............ 0 6,200,000
Meperidine.................. 9,753,000 9,753,000
Metazocine.................. 1 1
Methadone (for sale)........ 25,000,000 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 g 35,000,000 g
Morphine (for sale)......... 35,000,000 35,000,000
Morphine (for conversion)... 110,774,000 110,774,000
Nabilone.................... 3,002 3,002
Noroxymorphone (for sale)... 1,002 1,002
Noroxymorphone (for 11,000,000 11,000,000
conversion)................
Opium....................... 1,400,000 1,400,000
Oxycodone (for sale)........ 56,000,000 56,000,000
Oxycodone (for conversion).. 25,000,000 25,000,000
Oxymorphone................. 1,800,000 1,800,000
Oxymorphone (for conversion) 15,300,000 15,300,000
Pentobarbital............... 28,000,000 28,000,000
Phencyclidine............... 2,021 2,021
Phenmetrazine............... 2 2
[[Page 24611]]
Racemethorphan.............. 2 2
Remifentanil................ 5,000 5,000
Secobarbital................ 2 2
Sufentanil.................. 12,300 12,300
Thebaine.................... 102,000,000 102,000,000
------------------------------------------------------------------------
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
$120,000,000 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: April 25, 2007.
Michele M. Leonhart,
Deputy Administrator.
[FR Doc. E7-8422 Filed 5-2-07; 8:45 am]
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