Controlled Substances: Final Revised Aggregate Production Quotas for 2009, 54077-54080 [E9-25274]
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jlentini on DSKJ8SOYB1PROD with NOTICES
Federal Register / Vol. 74, No. 202 / Wednesday, October 21, 2009 / Notices
to groundwater at the Site, including a
Remedial Investigation/Feasibility
Study and the selection of a remedy for
contaminated groundwater at the Site.
In exchange for the City’s payment, the
City will receive from the United States
a covenant not to sue or to take
administrative action pursuant to
Sections 106 or 107 of CERCLA, 42
U.S.C. 9606 and 9607, as amended, for
the performance of response actions at
the Site and the United States’ past and
future response costs at the Site. In
addition, the City will dismiss its
CERCLA claims against the Forest
Service. The Department of Justice will
receive for a period of thirty (30) days
from the date of this publication
comments relating to the Consent
Decree. Comments should be addressed
to the Acting Assistant Attorney
General, Environment and Natural
Resources Division, and either e-mailed
to pubcomment-ees.enrd@usdoj.gov or
mailed to P.O. Box 7611, U.S.
Department of Justice, Washington, DC
20044–7611, and should refer to United
States of America v. El Dorado County,
California, et al., Civil No. S–01–1520
MCE GGH (E.D. Cal.) (DOJ Ref. No. 90–
11–3–06554)(Consent Decree with City).
The Consent Decree with the City may
be examined at U.S. Department of
Agriculture, Office of General Counsel,
33 New Montgomery Street, 17th Floor,
San Francisco, CA 94150 (contact Rose
Miksovsky, (415) 744–3158). During the
public comment period, the Consent
Decree with the District may also be
examined on the following Department
of Justice Web site, https://
www.usdoj.gov/enrd/
Consent_Decrees.html. A copy of the
Consent Decree with the City may also
be obtained by mail from the Consent
Decree Library, U.S. Department of
Justice, P.O. Box 7611, Washington, DC
20044–7611 or by faxing or e-mailing a
request to Tonia Fleetwood
(tonia.fleetwood@usdoj.gov), fax no.
(202) 514–0097, phone confirmation
number (202) 514–1547. In requesting a
copy from the Consent Decree Library,
please refer to United States of America
v. El Dorado County, California, et al.,
Civil No. S–01–1520 MCE GGH (E.D.
Cal.) (DOJ Ref. No. 90–11–3–06554)
(Consent Decree with City), and enclose
a check in the amount of $35.75 (25
cents per page reproduction cost)
payable to the U.S. Treasury or, if by
e-mail or fax, forward a check in that
VerDate Nov<24>2008
17:33 Oct 20, 2009
Jkt 220001
amount to the Consent Decree Library at
the stated address.
Maureen Katz,
Assistant Section Chief, Environmental
Enforcement Section, Environment and
Natural Resources Division.
[FR Doc. E9–25216 Filed 10–20–09; 8:45 am]
BILLING CODE 4410–15–P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA–317F]
Controlled Substances: Final Revised
Aggregate Production Quotas for 2009
AGENCY: Drug Enforcement
Administration (DEA), Justice.
ACTION: Notice of final aggregate
production quotas for 2009.
SUMMARY: This notice establishes final
2009 aggregate production quotas for
controlled substances in schedules I and
II of the Controlled Substances Act
(CSA). The DEA has taken into
consideration comments received in
response to a notice of the proposed
revised aggregate production quotas for
2009 published July 23, 2009 (74 FR
36511).
DATES: Effective Date: October 21, 2009.
FOR FURTHER INFORMATION CONTACT:
Christine A. Sannerud, Ph.D, Chief,
Drug and Chemical Evaluation Section,
Drug Enforcement Administration, 8701
Morrissette Drive, Springfield, Virginia
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 28 CFR 0.104.
The 2009 aggregate production quotas
represent those quantities of controlled
substances in schedules I and II that
may be produced in the United States in
2009 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 (21 U.S.C. 826(a) and 21
CFR 1303.11). These quotas do not
include imports of controlled
substances.
On July 23, 2009, a notice of the
proposed revised 2009 aggregate
production quotas for certain controlled
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Sfmt 4703
54077
substances in schedules I and II was
published in the Federal Register (74
FR 36511). All interested persons were
invited to comment on or object to these
proposed aggregate production quotas
on or before August 24, 2009.
Seven companies commented on a
total of 18 schedules I and II controlled
substances within the published
comment period. Seven companies
proposed that the aggregate production
quotas for amphetamine (for sale),
codeine (for conversion),
dihydromorphine, fentanyl,
hydrocodone (for sale), hydromorphone,
lisdexamfetamine, methadone,
methadone intermediate,
methamphetamine (for sale),
methylphenidate, nabilone, opium
(tincture), oxycodone (for sale),
oxycodone (for conversion),
oxymorphone (for sale), phenylacetone,
and thebaine were insufficient to
provide for the estimated medical,
scientific, research, and industrial needs
of the United States, for export
requirements and for the establishment
and maintenance of reserve stocks.
DEA has taken into consideration the
above comments along with the relevant
2008 year-end inventories, initial 2009
manufacturing quotas, 2009 export
requirements, actual and projected 2009
sales, research, product development
requirements, and additional
applications received. Based on this
information, the DEA has adjusted the
final 2009 aggregate production quotas
for amphetamine (for conversion),
dihydromorphine, hydrocodone (for
sale), hydromorphone,
lisdexamfetamine, morphine (for sale),
opium (tincture), oxycodone (for sale),
oxycodone (for conversion),
oxymorphone (for sale), and
phenylacetone to meet the legitimate
needs of the United States.
Regarding amphetamine (for sale),
codeine (for conversion), fentanyl,
methadone, methadone intermediate,
methamphetamine (for sale),
methylphenidate, nabilone, and
thebaine, the DEA has determined that
the proposed revised 2009 aggregate
production quotas are sufficient to meet
the current 2009 estimated medical,
scientific, research, and industrial needs
of the United States and to provide for
adequate inventories.
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 orders that the
2009 final aggregate production quotas
for the following controlled substances,
E:\FR\FM\21OCN1.SGM
21OCN1
54078
Federal Register / Vol. 74, No. 202 / Wednesday, October 21, 2009 / Notices
expressed in grams of anhydrous acid or
base, be established as follows:
Final revised
2009 quotas
jlentini on DSKJ8SOYB1PROD with NOTICES
Basic class—Schedule I
2,5–Dimethoxyamphetamine .....................................................................................................................................
2,5-Dimethoxy-4-ethylamphetamine (DOET) ............................................................................................................
3-Methylfentanyl .........................................................................................................................................................
3-Methylthiofentanyl ...................................................................................................................................................
3,4-Methylenedioxyamphetamine (MDA) ..................................................................................................................
3,4-Methylenedioxy-N-ethylamphetamine (MDEA) ...................................................................................................
3,4-Methylenedioxymethamphetamine (MDMA) .......................................................................................................
3,4,5-Trimethoxyamphetamine ..................................................................................................................................
4-Bromo-2,5-dimethoxyamphetamine (DOB) ............................................................................................................
4-Bromo-2,5-dimethoxyphenethylamine (2-CB) ........................................................................................................
4-Methoxyamphetamine ............................................................................................................................................
4-Methylaminorex ......................................................................................................................................................
4-Methyl-2,5-dimethoxyamphetamine (DOM) ............................................................................................................
5-Methoxy-3,4-methylenedioxyamphetamine ............................................................................................................
5-Methoxy-N,N-diisopropyltryptamine ........................................................................................................................
Acetyl-alpha-methylfentanyl .......................................................................................................................................
Acetyldihydrocodeine .................................................................................................................................................
Acetylmethadol ..........................................................................................................................................................
Allylprodine ................................................................................................................................................................
Alphacetylmethadol ....................................................................................................................................................
Alpha-ethyltryptamine ................................................................................................................................................
Alphameprodine .........................................................................................................................................................
Alphamethadol ...........................................................................................................................................................
Alpha-methylfentanyl .................................................................................................................................................
Alpha-methylthiofentanyl ............................................................................................................................................
Aminorex ....................................................................................................................................................................
Benzylmorphine .........................................................................................................................................................
Betacetylmethadol .....................................................................................................................................................
Beta-hydroxy-3-methylfentanyl ..................................................................................................................................
Beta-hydroxyfentanyl .................................................................................................................................................
Betameprodine ...........................................................................................................................................................
Betamethadol .............................................................................................................................................................
Betaprodine ................................................................................................................................................................
Bufotenine ..................................................................................................................................................................
Cathinone ...................................................................................................................................................................
Codeine-N-oxide ........................................................................................................................................................
Diethyltryptamine .......................................................................................................................................................
Difenoxin ....................................................................................................................................................................
Dihydromorphine ........................................................................................................................................................
Dimethyltryptamine ....................................................................................................................................................
Gamma-hydroxybutyric acid ......................................................................................................................................
Heroin ........................................................................................................................................................................
Hydromorphinol ..........................................................................................................................................................
Hydroxypethidine .......................................................................................................................................................
Ibogaine .....................................................................................................................................................................
Lysergic acid diethylamide (LSD) ..............................................................................................................................
Marihuana ..................................................................................................................................................................
Mescaline ...................................................................................................................................................................
Methaqualone ............................................................................................................................................................
Methcathinone ...........................................................................................................................................................
Methyldihydromorphine ..............................................................................................................................................
Morphine-N-oxide ......................................................................................................................................................
N-Benzylpiperazine ....................................................................................................................................................
N,N-Dimethylamphetamine ........................................................................................................................................
N-Ethylamphetamine .................................................................................................................................................
N-Hydroxy-3,4-methylenedioxyamphetamine ............................................................................................................
Noracymethadol .........................................................................................................................................................
Norlevorphanol ...........................................................................................................................................................
Normethadone ...........................................................................................................................................................
Normorphine ..............................................................................................................................................................
Para-fluorofentanyl .....................................................................................................................................................
Phenomorphan ..........................................................................................................................................................
Pholcodine .................................................................................................................................................................
Psilocybin ...................................................................................................................................................................
Psilocyn ......................................................................................................................................................................
Tetrahydrocannabinols ..............................................................................................................................................
Thiofentanyl ...............................................................................................................................................................
Trimeperidine .............................................................................................................................................................
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602
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3,000
3,132,000
3
24,200,00
20
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4,500,000
7
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2
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54079
Federal Register / Vol. 74, No. 202 / Wednesday, October 21, 2009 / Notices
Final revised
2009 quotas
Basic class—Schedule II
jlentini on DSKJ8SOYB1PROD with NOTICES
1-Phenylcyclohexylamine ..........................................................................................................................................
1-Piperdinocyclohexanecarbonitrile ...........................................................................................................................
Alfentanil ....................................................................................................................................................................
Alphaprodine ..............................................................................................................................................................
Amobarbital ................................................................................................................................................................
Amphetamine (for sale) .............................................................................................................................................
Amphetamine (for conversion) ..................................................................................................................................
Cocaine ......................................................................................................................................................................
Codeine (for sale) ......................................................................................................................................................
Codeine (for conversion) ...........................................................................................................................................
Dextropropoxyphene ..................................................................................................................................................
Dihydrocodeine ..........................................................................................................................................................
Diphenoxylate ............................................................................................................................................................
Ecgonine ....................................................................................................................................................................
Ethylmorphine ............................................................................................................................................................
Fentanyl .....................................................................................................................................................................
Glutethimide ...............................................................................................................................................................
Hydrocodone (for sale) ..............................................................................................................................................
Hydromorphone .........................................................................................................................................................
Isomethadone ............................................................................................................................................................
Levo-alphacetylmethadol (LAAM) ..............................................................................................................................
Levomethorphan ........................................................................................................................................................
Levorphanol ...............................................................................................................................................................
Lisdexamfetamine ......................................................................................................................................................
Meperidine .................................................................................................................................................................
Meperidine Intermediate-A ........................................................................................................................................
Meperidine Intermediate-B ........................................................................................................................................
Meperidine Intermediate-C ........................................................................................................................................
Metazocine .................................................................................................................................................................
Methadone (for sale) .................................................................................................................................................
Methadone Intermediate ............................................................................................................................................
Methamphetamine .....................................................................................................................................................
Methylphenidate .........................................................................................................................................................
Morphine (for sale) ....................................................................................................................................................
Morphine (for conversion) ..........................................................................................................................................
Nabilone .....................................................................................................................................................................
Noroxymorphone (for sale) ........................................................................................................................................
Noroxymorphone (for conversion) .............................................................................................................................
Opium (powder) .........................................................................................................................................................
Opium (tincture) .........................................................................................................................................................
Oripavine ....................................................................................................................................................................
Oxycodone (for sale) .................................................................................................................................................
Oxycodone (for conversion) ......................................................................................................................................
Oxymorphone (for sale) .............................................................................................................................................
Oxymorphone (for conversion) ..................................................................................................................................
Pentobarbital ..............................................................................................................................................................
Phenazocine ..............................................................................................................................................................
Phencyclidine .............................................................................................................................................................
Phenmetrazine ...........................................................................................................................................................
Phenylacetone ...........................................................................................................................................................
Racemethorphan .......................................................................................................................................................
Remifentanil ...............................................................................................................................................................
Secobarbital ...............................................................................................................................................................
Sufentanil ...................................................................................................................................................................
Thebaine ....................................................................................................................................................................
DEA proposed the aggregate
production quota for tapentadol at
519,000 g in the 2009 proposed revised
aggregate production quota notice
published on July 23, 2009, in the
Federal Register (74 FR 36511).
Tapentadol is no longer listed because
the material will be imported into the
United States and not manufactured
domestically.
The Deputy Administrator further
orders that the aggregate production
quotas for all other schedules I and II
VerDate Nov<24>2008
17:33 Oct 20, 2009
Jkt 220001
controlled substances included in 21
CFR 1308.11 and 1308.12 shall be zero.
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
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2
2
8,000
2
3
17,000,000
7,500,000
247,000
39,605,000
65,000,000
106,000,000
1,200,000
947,000
83,000
2
1,428,000
2
55,500,000
3,340,000
2
3
5
10,000
8,200,000
8,600,000
3
7
3
1
25,000,000
26,000,000
3,130,000
50,000,000
36,300,000
100,000,000
9,002
10,000
9,000,000
230,000
1,250,000
15,000,000
94,000,000
4,500,000
2,570,000
12,000,000
28,000,000
1
20
2
250,001
2
500
67,000
10,300
126,000,000
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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
E:\FR\FM\21OCN1.SGM
21OCN1
54080
Federal Register / Vol. 74, No. 202 / Wednesday, October 21, 2009 / Notices
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 foreignbased companies in domestic and
export markets.
Dated: October 13, 2009.
Michele M. Leonhart,
Deputy Administrator.
[FR Doc. E9–25274 Filed 10–20–09; 8:45 am]
BILLING CODE 4410–09–P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[DEA # 318E]
Controlled Substances: Established
Initial Aggregate Production Quotas
for 2010
jlentini on DSKJ8SOYB1PROD with NOTICES
AGENCY: Drug Enforcement
Administration (DEA), Justice.
ACTION: Notice of aggregate production
quotas for 2010.
SUMMARY: This notice establishes initial
2010 aggregate production quotas for
controlled substances in schedules I and
II of the Controlled Substances Act
(CSA).
DATES:
Effective Date: October 21, 2009.
VerDate Nov<24>2008
17:33 Oct 20, 2009
Jkt 220001
FOR FURTHER INFORMATION CONTACT:
Christine A. Sannerud, Ph.D, Chief,
Drug & 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.
The 2010 aggregate production quotas
represent those quantities of controlled
substances that may be produced in the
United States in 2010 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 (21
U.S.C. 826(a) and 21 CFR 1303.11).
These quotas do not include imports of
controlled substances for use in
industrial processes.
On May 21, 2009, a notice of the
proposed initial 2010 aggregate
production quotas for certain controlled
substances in schedules I and II was
published in the Federal Register (74
FR 23881). All interested persons were
invited to comment on or object to these
proposed aggregate production quotas
on or before June 22, 2009.
Twelve responses (eleven from DEA
registered manufacturers, and one from
a non-DEA registrant) were received
within the published comment period,
offering comments on a total of 28
schedule I and II controlled substances.
One additional comment was received
after the comment period ended and
therefore was not considered. The
commenters stated that the proposed
aggregate production quotas for 3,4methylenedioxyamphetamine, 3,4methylenedioxyethylamphetamine, 3,4methylenedioxymethamphetamine,
alfentanil, amphetamine (for sale),
codeine (for sale), codeine (for
conversion), dihydromorphine,
fentanyl, gamma hydroxybutyric acid,
hydrocodone, hydromorphone,
isomethadone, levo-desoxyephedrine,
levorphanol, lisdexamfetamine,
methamphetamine (for sale), morphine
(for conversion), nabilone, opium
(tincture), oxycodone (for sale),
oxycodone (for conversion),
oxymorphone (for sale), remifentanil,
sufentanil, tapentadol,
PO 00000
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Fmt 4703
Sfmt 4703
tetrahydrocannabinols, and thebaine
were insufficient to provide for the
estimated medical, scientific, research
and industrial needs of the United
States, for export requirements and for
the establishment and maintenance of
reserve stocks.
In arriving at the aggregate production
quotas, DEA has taken into
consideration the above comments
along with the factors set forth at 21
CFR 1303.11(b) and other relevant 2009
factors, including 2009 manufacturing
quotas, current 2009 sales and
inventories, 2010 export requirements,
additional applications received, and
research and product development
requirements. Based on this
information, DEA has adjusted the
initial aggregate production quotas for 4methoxyamphetamine, alphamethyltryptamine, amphetamine (for
conversion), dihydromorphine,
isomethadone, levo-desoxyephedrine,
lisdexamfetamine, lysergic acid
diethylamide, methamphetamine (for
sale), methamphetamine (for
conversion), methaqualone, oxycodone
(for sale), oxycodone (for conversion),
oxymorphone (for sale) and
phenylacetone to meet the legitimate
needs of the United States.
DEA proposed the aggregate
production quota for tapentadol at
519,000 g in the 2010 proposed initial
aggregate production quota notice
published on May 21, 2009 in the
Federal Register (74 FR 23881).
Tapentadol is no longer listed because
the material will be imported into the
United States and not manufactured
domestically.
Regarding 3,4methylenedioxyamphetamine, 3,4methylenedioxyethylamphetamine, 3,4methylenedioxymethamphetamine,
alfentanil, amphetamine (for sale),
codeine (for sale), codeine (for
conversion), fentanyl, gamma
hydroxybutyric acid, hydrocodone,
hydromorphone, levorphanol, morphine
(for conversion), nabilone, opium
(tincture), remifentanil, sufentanil,
tetrahydrocannabinols, and thebaine
DEA has determined that the proposed
initial 2010 aggregate production quotas
are sufficient to meet the current 2010
estimated medical, scientific, research
and industrial needs of the United
States.
Pursuant to 21 CFR 1303, the Deputy
Administrator of DEA will, in 2010,
adjust aggregate production quotas and
individual manufacturing quotas
allocated for the year based upon 2009
year-end inventory and actual 2009
disposition data supplied by quota
recipients for each basic class of
schedule I or II controlled substance.
E:\FR\FM\21OCN1.SGM
21OCN1
Agencies
[Federal Register Volume 74, Number 202 (Wednesday, October 21, 2009)]
[Notices]
[Pages 54077-54080]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-25274]
-----------------------------------------------------------------------
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA-317F]
Controlled Substances: Final Revised Aggregate Production Quotas
for 2009
AGENCY: Drug Enforcement Administration (DEA), Justice.
ACTION: Notice of final aggregate production quotas for 2009.
-----------------------------------------------------------------------
SUMMARY: This notice establishes final 2009 aggregate production quotas
for controlled substances in schedules I and II of the Controlled
Substances Act (CSA). The DEA has taken into consideration comments
received in response to a notice of the proposed revised aggregate
production quotas for 2009 published July 23, 2009 (74 FR 36511).
DATES: Effective Date: October 21, 2009.
FOR FURTHER INFORMATION CONTACT: Christine A. Sannerud, Ph.D, Chief,
Drug and Chemical Evaluation Section, Drug Enforcement Administration,
8701 Morrissette Drive, Springfield, Virginia 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 28 CFR 0.104.
The 2009 aggregate production quotas represent those quantities of
controlled substances in schedules I and II that may be produced in the
United States in 2009 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 (21 U.S.C. 826(a) and 21 CFR
1303.11). These quotas do not include imports of controlled substances.
On July 23, 2009, a notice of the proposed revised 2009 aggregate
production quotas for certain controlled substances in schedules I and
II was published in the Federal Register (74 FR 36511). All interested
persons were invited to comment on or object to these proposed
aggregate production quotas on or before August 24, 2009.
Seven companies commented on a total of 18 schedules I and II
controlled substances within the published comment period. Seven
companies proposed that the aggregate production quotas for amphetamine
(for sale), codeine (for conversion), dihydromorphine, fentanyl,
hydrocodone (for sale), hydromorphone, lisdexamfetamine, methadone,
methadone intermediate, methamphetamine (for sale), methylphenidate,
nabilone, opium (tincture), oxycodone (for sale), oxycodone (for
conversion), oxymorphone (for sale), phenylacetone, and thebaine were
insufficient to provide for the estimated medical, scientific,
research, and industrial needs of the United States, for export
requirements and for the establishment and maintenance of reserve
stocks.
DEA has taken into consideration the above comments along with the
relevant 2008 year-end inventories, initial 2009 manufacturing quotas,
2009 export requirements, actual and projected 2009 sales, research,
product development requirements, and additional applications received.
Based on this information, the DEA has adjusted the final 2009
aggregate production quotas for amphetamine (for conversion),
dihydromorphine, hydrocodone (for sale), hydromorphone,
lisdexamfetamine, morphine (for sale), opium (tincture), oxycodone (for
sale), oxycodone (for conversion), oxymorphone (for sale), and
phenylacetone to meet the legitimate needs of the United States.
Regarding amphetamine (for sale), codeine (for conversion),
fentanyl, methadone, methadone intermediate, methamphetamine (for
sale), methylphenidate, nabilone, and thebaine, the DEA has determined
that the proposed revised 2009 aggregate production quotas are
sufficient to meet the current 2009 estimated medical, scientific,
research, and industrial needs of the United States and to provide for
adequate inventories.
Therefore, under the authority vested in the Attorney General by
Section 306 of the CSA (21 U.S.C. Sec. 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 orders that the 2009 final aggregate production quotas for the
following controlled substances,
[[Page 54078]]
expressed in grams of anhydrous acid or base, be established as
follows:
------------------------------------------------------------------------
Basic class--Schedule I Final revised 2009 quotas
------------------------------------------------------------------------
2,5-Dimethoxyamphetamine.................. 2 g
2,5-Dimethoxy-4-ethylamphetamine (DOET)... 2 g
3-Methylfentanyl.......................... 2 g
3-Methylthiofentanyl...................... 2 g
3,4-Methylenedioxyamphetamine (MDA)....... 25 g
3,4-Methylenedioxy-N-ethylamphetamine 10 g
(MDEA)...................................
3,4-Methylenedioxymethamphetamine (MDMA).. 20 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...................... 27 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 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............................. 2 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................................ 3 g
Cathinone................................. 3 g
Codeine-N-oxide........................... 602 g
Diethyltryptamine......................... 2 g
Difenoxin................................. 3,000 g
Dihydromorphine........................... 3,132,000 g
Dimethyltryptamine........................ 3 g
Gamma-hydroxybutyric acid................. 24,200,00 g
Heroin.................................... 20 g
Hydromorphinol............................ 2 g
Hydroxypethidine.......................... 2 g
Ibogaine.................................. 1 g
Lysergic acid diethylamide (LSD).......... 10 g
Marihuana................................. 4,500,000 g
Mescaline................................. 7 g
Methaqualone.............................. 5 g
Methcathinone............................. 4 g
Methyldihydromorphine..................... 2 g
Morphine-N-oxide.......................... 605 g
N-Benzylpiperazine........................ 2 g
N,N-Dimethylamphetamine................... 7 g
N-Ethylamphetamine........................ 2 g
N-Hydroxy-3,4-methylenedioxyamphetamine... 2 g
Noracymethadol............................ 2 g
Norlevorphanol............................ 52 g
Normethadone.............................. 2 g
Normorphine............................... 16 g
Para-fluorofentanyl....................... 2 g
Phenomorphan.............................. 2 g
Pholcodine................................ 2 g
Psilocybin................................ 7 g
Psilocyn.................................. 7 g
Tetrahydrocannabinols..................... 312,500 g
Thiofentanyl.............................. 2 g
Trimeperidine............................. 2 g
------------------------------------------------------------------------
[[Page 54079]]
------------------------------------------------------------------------
Basic class--Schedule II Final revised 2009 quotas
------------------------------------------------------------------------
1-Phenylcyclohexylamine................... 2 g
1-Piperdinocyclohexanecarbonitrile........ 2 g
Alfentanil................................ 8,000 g
Alphaprodine.............................. 2 g
Amobarbital............................... 3 g
Amphetamine (for sale).................... 17,000,000 g
Amphetamine (for conversion).............. 7,500,000 g
Cocaine................................... 247,000 g
Codeine (for sale)........................ 39,605,000 g
Codeine (for conversion).................. 65,000,000 g
Dextropropoxyphene........................ 106,000,000 g
Dihydrocodeine............................ 1,200,000 g
Diphenoxylate............................. 947,000 g
Ecgonine.................................. 83,000 g
Ethylmorphine............................. 2 g
Fentanyl.................................. 1,428,000 g
Glutethimide.............................. 2 g
Hydrocodone (for sale).................... 55,500,000 g
Hydromorphone............................. 3,340,000 g
Isomethadone.............................. 2 g
Levo-alphacetylmethadol (LAAM)............ 3 g
Levomethorphan............................ 5 g
Levorphanol............................... 10,000 g
Lisdexamfetamine.......................... 8,200,000 g
Meperidine................................ 8,600,000 g
Meperidine Intermediate-A................. 3 g
Meperidine Intermediate-B................. 7 g
Meperidine Intermediate-C................. 3 g
Metazocine................................ 1 g
Methadone (for sale)...................... 25,000,000 g
Methadone Intermediate.................... 26,000,000 g
Methamphetamine........................... 3,130,000 g
Methylphenidate........................... 50,000,000 g
Morphine (for sale)....................... 36,300,000 g
Morphine (for conversion)................. 100,000,000 g
Nabilone.................................. 9,002 g
Noroxymorphone (for sale)................. 10,000 g
Noroxymorphone (for conversion)........... 9,000,000 g
Opium (powder)............................ 230,000 g
Opium (tincture).......................... 1,250,000 g
Oripavine................................. 15,000,000 g
Oxycodone (for sale)...................... 94,000,000 g
Oxycodone (for conversion)................ 4,500,000 g
Oxymorphone (for sale).................... 2,570,000 g
Oxymorphone (for conversion).............. 12,000,000 g
Pentobarbital............................. 28,000,000 g
Phenazocine............................... 1 g
Phencyclidine............................. 20 g
Phenmetrazine............................. 2 g
Phenylacetone............................. 250,001 g
Racemethorphan............................ 2 g
Remifentanil.............................. 500 g
Secobarbital.............................. 67,000 g
Sufentanil................................ 10,300 g
Thebaine.................................. 126,000,000 g
------------------------------------------------------------------------
DEA proposed the aggregate production quota for tapentadol at
519,000 g in the 2009 proposed revised aggregate production quota
notice published on July 23, 2009, in the Federal Register (74 FR
36511). Tapentadol is no longer listed because the material will be
imported into the United States and not manufactured domestically.
The Deputy Administrator further orders that the aggregate
production quotas for all other schedules I and II controlled
substances included in 21 CFR 1308.11 and 1308.12 shall be zero.
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
[[Page 54080]]
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: October 13, 2009.
Michele M. Leonhart,
Deputy Administrator.
[FR Doc. E9-25274 Filed 10-20-09; 8:45 am]
BILLING CODE 4410-09-P