[Federal Register Volume 73, Number 127 (Tuesday, July 1, 2008)]
[Notices]
[Pages 37496-37498]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E8-14903]
[[Page 37496]]
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA-307R]
Controlled Substances: Proposed Revised Aggregate Production
Quotas for 2008
AGENCY: Drug Enforcement Administration (DEA), Justice.
ACTION: Notice of proposed revised 2008 aggregate production quotas.
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SUMMARY: This notice proposes revised 2008 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 31, 2008.
ADDRESSES: To ensure proper handling of comments, please reference
``Docket No. DEA-307R'' on all written and electronic correspondence.
Written comments sent via regular or express mail should be sent to DEA
Headquarters, Attention: DEA Federal Register Representative/ODL, 8701
Morrissette Drive, Springfield, VA 22152. Comments may be directly sent
to DEA electronically by sending an electronic message to
[email protected]. However, persons wishing to request a
hearing should note that such requests must be written and manually
signed; requests for a hearing will not be accepted via electronic
means. 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,
8701 Morrissette Drive, Springfield, VA 22152, 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 August 24, 2007, a notice of proposed 2008 aggregate production
quotas for certain controlled substances in schedules I and II was
published in the Federal Register (72 FR 48683). This notice stipulated
that the DEA would adjust the quotas in early 2008 as provided for in
21 CFR part 1303.
The proposed revised 2008 aggregate production quotas represent
those quantities of controlled substances in schedules I and II that
may be produced in the United States in 2008 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 2007 year-end
inventories, 2007 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 2008 aggregate production quotas for the
following controlled substances, expressed in grams of anhydrous acid
or base:
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Previously
established Proposed revised
Basic class--Schedule I initial 2008 2008 quotas
quotas
----------------------------------------------------------------------------------------------------------------
2,5-Dimethoxyamphetamine.................................................... 2 g 2 g
2,5-Dimethoxy-4-ethylamphetamine (DOET)..................................... 2 g 2 g
2,5-Dimethoxy-4-(n)-propylthiophenethylamine (2C-T-7)....................... 10 g 10 g
3-Methylfentanyl............................................................ 2 g 2 g
3-Methylthiofentanyl........................................................ 2 g 2 g
3,4-Methylenedioxyamphetamine (MDA)......................................... 20 g 20 g
3,4-Methylenedioxy-N-ethylamphetamine (MDEA)................................ 10 g 10 g
3,4-Methylenedioxymethamphetamine (MDMA).................................... 22 g 22 g
3,4,5-Trimethoxyamphetamine................................................. 2 g 2 g
4-Bromo-2,5-dimethoxyamphetamine (DOB)...................................... 2 g 2 g
4-Bromo-2,5-dimethoxyphenethylamine (2-CB).................................. 7 g 7 g
4-Methoxyamphetamine........................................................ 77 g 77 g
4-Methylaminorex............................................................ 2 g 2 g
4-Methyl-2,5-dimethoxyamphetamine (DOM)..................................... 12 g 12 g
5-Methoxy-3,4-methylenedioxyamphetamine..................................... 2 g 2 g
5-Methoxy-N,N-diisopropyltryptamine......................................... 5 g 5 g
Acetyl-alpha-methylfentanyl................................................. 2 g 2 g
Acetyldihydrocodeine........................................................ 2 g 2 g
Acetylmethadol.............................................................. 2 g 2 g
Allylprodine................................................................ 2 g 2 g
Alphacetylmethadol.......................................................... 2 g 2 g
Alpha-ethyltryptamine....................................................... 2 g 2 g
Alphameprodine.............................................................. 2 g 2 g
Alphamethadol............................................................... 3 g 3 g
Alpha-methylfentanyl........................................................ 2 g 2 g
Alpha-methylthiofentanyl.................................................... 2 g 2 g
Alpha-methyltryptamine...................................................... 5 g 5 g
Aminorex.................................................................... 8 g 8 g
Benzylmorphine.............................................................. 2 g 2 g
Betacetylmethadol........................................................... 2 g 2 g
Beta-hydroxy-3-methylfentanyl............................................... 2 g 2 g
Beta-hydroxyfentanyl........................................................ 2 g 2 g
[[Page 37497]]
Betameprodine............................................................... 2 g 2 g
Betamethadol................................................................ 2 g 2 g
Betaprodine................................................................. 2 g 2 g
Bufotenine.................................................................. 8 g 8 g
Cathinone................................................................... 3 g 3 g
Codeine-N-oxide............................................................. 302 g 302 g
Diethyltryptamine........................................................... 2 g 2 g
Difenoxin................................................................... 50 g 50 g
Dihydromorphine............................................................. 2,549,000 g 2,549,000 g
Dimethyltryptamine.......................................................... 3 g 3 g
Gamma-hydroxybutyric acid................................................... 23,600,000 g 21,940,000 g
Heroin...................................................................... 5 g 5 g
Hydromorphinol.............................................................. 3,000 g 3,000 g
Hydroxypethidine............................................................ 2 g 2 g
Ibogaine.................................................................... 1 g 1 g
Lysergic acid diethylamide (LSD)............................................ 61 g 61 g
Marihuana................................................................... 4,500,000 g 4,500,000 g
Mescaline................................................................... 2 g 2 g
Methaqualone................................................................ 10 g 10 g
Methcathinone............................................................... 4 g 4 g
Methyldihydromorphine....................................................... 2 g 2 g
Morphine-N-oxide............................................................ 310 g 310 g
N,N-Dimethylamphetamine..................................................... 7 g 7 g
N-Ethylamphetamine.......................................................... 2 g 2 g
N-Hydroxy-3,4-methylenedioxyamphetamine..................................... 2 g 2 g
Noracymethadol.............................................................. 2 g 2 g
Norlevorphanol.............................................................. 52 g 52 g
Normethadone................................................................ 2 g 2 g
Normorphine................................................................. 16 g 16 g
Para-fluorofentanyl......................................................... 2 g 2 g
Phenomorphan................................................................ 2 g 2 g
Pholcodine.................................................................. 2 g 2 g
Psilocybin.................................................................. 7 g 7 g
Psilocyn.................................................................... 7 g 7 g
Tetrahydrocannabinols....................................................... 312,500 g 312,500 g
Thiofentanyl................................................................ 2 g 2 g
Trimeperidine............................................................... 2 g 2 g
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Previously
established Proposed revised
Basic class--Schedule II initial 2008 2008 quotas
quotas
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1-Phenylcyclohexylamine..................................................... 2 g 2 g
Alfentanil.................................................................. 8,000 g 8,000 g
Alphaprodine................................................................ 2 g 2 g
Amobarbital................................................................. 3 g 3 g
Amphetamine (for sale)...................................................... 17,000,000 g 17,000,000 g
Amphetamine (for conversion)................................................ 5,000,000 g 5,000,000 g
Cocaine..................................................................... 286,000 g 247,000 g
Codeine (for sale).......................................................... 39,605,000 g 39,605,000 g
Codeine (for conversion).................................................... 59,000,000 g 59,000,000 g
Dextropropoxyphene.......................................................... 106,000,000 g 106,000,000 g
Dihydrocodeine.............................................................. 1,200,000 g 1,200,000 g
Diphenoxylate............................................................... 828,000 g 680,000 g
Ecgonine.................................................................... 83,000 g 83,000 g
Ethylmorphine............................................................... 2 g 2 g
Fentanyl.................................................................... 1,428,000 g 1,428,000 g
Glutethimide................................................................ 2 g 2 g
Hydrocodone (for sale)...................................................... 45,200,000 g 42,000,000 g
Hydrocodone (for conversion)................................................ 1,500,000 g 1,500,000 g
Hydromorphone............................................................... 3,300,000 g 3,300,000 g
Isomethadone................................................................ 2 g 2 g
Levo-alphacetylmethadol (LAAM).............................................. 3 g 3 g
Levomethorphan.............................................................. 5 g 5 g
Levorphanol................................................................. 10,000 g 10,000 g
Lisdexamfetamine............................................................ 6,200,000 g 6,200,000 g
Meperidine.................................................................. 9,753,000 g 8,600,000 g
Metazocine.................................................................. 1 g 1 g
Methadone (for sale)........................................................ 25,000,000 g 25,000,000 g
Methadone Intermediate...................................................... 26,000,000 g 26,000,000 g
Methamphetamine............................................................. 3,130,000 g 3,130,000 g
[[Page 37498]]
[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)]
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Methylphenidate............................................................. 50,000,000 g 50,000,000 g
Morphine (for sale)......................................................... 35,000,000 g 35,000,000 g
Morphine (for conversion)................................................... 100,000,000 g 100,000,000 g
Nabilone.................................................................... 3,002 g 3,002 g
Noroxymorphone (for sale)................................................... 10,000 g 10,000 g
Noroxymorphone (for conversion)............................................. 8,000,000 g 8,000,000 g
Oripavine\1\................................................................ 0 g 15,000,000 g
Opium....................................................................... 1,400,000 g 1,400,000 g
Oxycodone (for sale)........................................................ 70,000,000 g 70,000,000 g
Oxycodone (for conversion).................................................. 4,820,000 g 4,820,000 g
Oxymorphone................................................................. 2,400,000 g 2,000,000 g
Oxymorphone (for conversion)................................................ 11,000,000 g 11,000,000 g
Pentobarbital............................................................... 35,200,000 g 28,000,000 g
Phencyclidine............................................................... 2,021 g 2,021 g
Phenmetrazine............................................................... 2 g 2 g
Racemethorphan.............................................................. 2 g 2 g
Remifentanil................................................................ 3,000 g 410 g
Secobarbital................................................................ 2 g 2 g
Sufentanil.................................................................. 10,300 g 10,300 g
Thebaine.................................................................... 126,000,000 g 126,000,000 g
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\1\ On December 10, 2007, the Drug Enforcement Administration published a final rule establishing a new basic
class: Oripavine (72 FR 69618). Prior to the final rule, oripavine was considered a thebaine derivative and
hence, was included under the thebaine basic class.
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. Persons wishing to request a hearing should
note that such requests must be written and manually signed; requests
for a hearing will not be accepted via electronic means.
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).
Regulatory Certifications
Regulatory Flexibility Act
The Deputy Administrator hereby certifies that this action will not
have a significant economic impact upon small entities whose interests
must be considered under the Regulatory Flexibility Act, 5 U.S.C. 601-
612. 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 lawful 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.
Executive Order 12866
The Office of Management and Budget has determined that notices of
aggregate production quotas are not subject to centralized review under
Executive Order 12866.
Executive Order 13132
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.
Executive Order 12988
This action meets the applicable standards set forth in Sections
3(a) and 3(b)(2) of Executive Order 12988 Civil Justice Reform.
Unfunded Mandates Reform Act of 1995
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 (adjusted for inflation) 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.
Congressional Review Act
This action is not a major rule as defined by Section 804 of the
Small Business Regulatory Enforcement Fairness Act of 1996
(Congressional Review Act). 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 6, 2008.
Michele M. Leonhart,
Deputy Administrator.
[FR Doc. E8-14903 Filed 6-30-08; 8:45 am]
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