Controlled Substances: Established Initial Aggregate Production Quotas for 2011, 79404-79407 [2010-31849]
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79404
Federal Register / Vol. 75, No. 243 / Monday, December 20, 2010 / Notices
VIII. Notification
Unless such transaction is otherwise
subject to the reporting and waiting period
requirements of the Hart-Scott-Rodino
Antitrust Improvements Act of 1976, as
amended, 15 U.S.C. 18a (the ‘‘HSR Act’’),
during the term of this Final Judgment,
Defendants, without providing advance
notification to the Antitrust Division, shall
not directly or indirectly: (a) Acquire any
assets of or any interest (including, but not
limited to, any financial, security, loan,
equity, or management interest) in, any
company in the business of designing,
developing, producing, marketing, servicing,
distributing, and/or selling bonded insulated
rail joints and/or polyurethane-coated
insulated rail joints, or any company in the
business of producing, marketing,
distributing, and/or selling Friction
Management Products; or (b) enter into any
relationship with another company that
involves the distribution of Friction
Management Products in North America.
Such notification shall be provided to the
Antitrust Division in the same format as, and
per the instructions relating to the
Notification and Report Form set forth in the
Appendix to Part 803 of Title 16 of the Code
of Federal Regulations as amended, except
that the information requested in Items 5
through 9 of the instructions must be
provided only about bonded insulated rail
joints, polyurethane-coated insulated rail
joints, and Friction Management Products.
Notification shall be provided at least thirty
(30) calendar days prior to acquiring any
such interest, and shall include, beyond what
may be required by the applicable
instructions, the names of the principal
representatives of the parties to the
agreement who negotiated the agreement,
and any management or strategic plans
discussing the proposed transaction. If
within the 30-day period after notification,
representatives of the Antitrust Division
make a written request for additional
information, Defendants shall not
consummate the proposed transaction or
agreement until thirty (30) calendar days
after submitting all such additional
information. Early termination of the waiting
periods in this paragraph may be requested
and, where appropriate, granted in the same
manner as is applicable under the
requirements and provisions of the HSR Act
and rules promulgated thereunder. This
Section shall be broadly construed and any
ambiguity or uncertainty regarding the filing
of notice under this Section shall be resolved
in favor of filing notice.
jlentini on DSKJ8SOYB1PROD with NOTICES
IX. No Reacquisition
Defendants may not reacquire any part of
the Divestiture Assets during the term of this
Final Judgment.
X. Retention of Jurisdiction
This Court retains jurisdiction to enable
any party to this Final Judgment to apply to
this Court at any time for further orders and
directions as may be necessary or appropriate
to carry out or construe this Final Judgment,
to modify any of its provisions, to enforce
compliance, and to punish violations of its
provisions.
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17:18 Dec 17, 2010
Jkt 223001
XI. Expiration of Final Judgment
Unless this Court grants an extension, this
Final Judgment shall expire ten (10) years
from the date of its entry.
XII. Public Interest Determination
Entry of this Final Judgment is in the
public interest. The parties have complied
with the requirements of the Antitrust
Procedures and Penalties Act, 15 U.S.C. 16,
including making copies available to the
public of this Final Judgment, the
Competitive Impact Statement, and any
comments thereon and the United States’s
responses to comments. Based upon the
record before the Court, which includes the
Competitive Impact Statement and any
comments and responses to comments filed
with the Court, entry of this Final Judgment
is in the public interest.
Court approval subject to procedures of
Antitrust Procedures and Penalties Act, 15
U.S.C. § 16 United States District Judge.
[FR Doc. 2010–31863 Filed 12–17–10; 8:45 am]
BILLING CODE 4410–11–P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[DEA #343E]
Controlled Substances: Established
Initial Aggregate Production Quotas
for 2011
Drug Enforcement
Administration (DEA), Justice.
ACTION: Notice of aggregate production
quotas for 2011.
AGENCY:
This notice establishes initial
2011 aggregate production quotas for
controlled substances in schedules I and
II of the Controlled Substances Act
(CSA).
DATES: Effective Date: December 20,
2010.
FOR FURTHER INFORMATION CONTACT:
Christine A. Sannerud, PhD, Chief, Drug
& Chemical Evaluation Section, Drug
Enforcement Administration,
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 to 28 CFR
0.104.
The 2011 aggregate production quotas
represent those quantities of controlled
substances that may be produced in the
United States in 2011 to provide
SUMMARY:
PO 00000
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Fmt 4703
Sfmt 4703
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 September 15, 2010, a notice of
the proposed initial 2011 aggregate
production quotas for certain controlled
substances in schedules I and II was
published in the Federal Register (75
FR 56137). All interested persons were
invited to comment on or object to these
proposed aggregate production quotas
on or before October 15, 2010.
Seven responses (six from DEA
registered manufacturers, and one from
a non-DEA registrant) were received
within the published comment period,
offering comments on a total of 31
schedules I and II controlled substances.
The commenters stated that the
proposed aggregate production quotas
for 3,4-methylenedioxyamphetamine,
3,4-methylenedioxy-Nethylamphetamine, 3,4methylenedioxymethamphetamine,
4-anilino-N-phenethyl-4-piperidine,
amphetamine (for sale), cathinone,
codeine (for sale), dihydromorphine,
fentanyl, gamma hydroxybutyric acid,
heroin, hydrocodone, hydromorphone,
marihuana, meperidine, methaqualone,
methylphenidate, morphine (for
conversion), morphine (for sale),
nabilone, noroxymorphone (for
conversion), opium (tincture),
oxycodone (for sale), pentobarbital,
phencyclidine, remifentanil,
secobarbital, tapentadol,
tetrahydrocannabinols, thebaine and
tilidine 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 2010
factors, including 2010 manufacturing
quotas, current 2010 sales and
inventories, 2011 export requirements,
additional applications received, as well
as research and product development
requirements. Based on this
information, DEA has adjusted the
initial aggregate production quotas for
3,4-methylenedioxyamphetamine, 3,4methylenedioxy-N-ethylamphetamine,
3,4-methylenedioxymethamphetamine,
amobarbital, cathinone,
dimethyltryptamine, ibogaine, lysergic
E:\FR\FM\20DEN1.SGM
20DEN1
79405
Federal Register / Vol. 75, No. 243 / Monday, December 20, 2010 / Notices
acid diethylamide, metazocine,
methaqualone, nabilone, normorphine,
noroxymorphone (for sale),
phenazocine, phencyclidine,
secobarbital, and tetrahydrocannabinols
to meet the legitimate needs of the
United States.
Regarding 4-anilino-N-phenethyl-4piperidine, amphetamine (for sale),
codeine (for sale), dihydromorphine,
fentanyl, gamma hydroxybutyric acid,
heroin, hydrocodone, hydromorphone,
marihuana, meperidine,
methylphenidate, morphine (for
conversion), morphine (for sale),
noroxymorphone (for conversion),
opium (tincture), oxycodone (for sale),
pentobarbital, remifentanil, tapentadol,
thebaine and tilidine DEA has
determined that the proposed initial
2011 aggregate production quotas are
sufficient to meet the current 2011
estimated medical, scientific, research,
and industrial needs of the United
States.
Pursuant to 21 CFR 1303, the Deputy
Administrator of DEA will, in 2011,
adjust aggregate production quotas and
individual manufacturing quotas
allocated for the year based upon 2010
year-end inventory and actual 2010
disposition data supplied by quota
recipients for each basic class of
schedule I or II controlled substance.
Therefore, under the authority vested
in the Attorney General by Section 306
of the CSA (21 U.S.C. 826), and
delegated to the Administrator of 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 2011 initial
aggregate production quotas for the
following controlled substances,
expressed in grams of anhydrous acid or
base, be established as follows:
Established 2011
quotas
jlentini on DSKJ8SOYB1PROD with NOTICES
Basic class—Schedule I
1-Methyl-4-phenyl-4-propionoxypiperidine ...............................................................................................................................
2,5-Dimethoxyamphetamine ....................................................................................................................................................
2,5-Dimethoxy-4-ethylamphetamine (DOET) ..........................................................................................................................
2,5-Dimethoxy-4-n-propylthiophenethylamine .........................................................................................................................
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 ..........................................................................................................................................................
Alpha-methyltryptamine (AMT) ................................................................................................................................................
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 ....................................................................................................................................................................
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E:\FR\FM\20DEN1.SGM
20DEN1
2g
2g
2g
2g
2g
2g
22 g
15 g
22 g
2g
2g
2g
77 g
2g
2g
2g
2g
2g
2g
2g
2g
2g
2g
2g
2g
2g
2g
2g
2g
2g
2g
2g
2g
2g
2g
2g
3g
4g
602 g
2g
3,000 g
3,608,000 g
7g
3,000,000 g
20 g
2g
2g
5g
16 g
21,000 g
5g
10 g
4g
2g
605 g
79406
Federal Register / Vol. 75, No. 243 / Monday, December 20, 2010 / Notices
Established 2011
quotas
Basic class—Schedule I
N-Benzylpiperazine ..................................................................................................................................................................
N,N-Dimethylamphetamine ......................................................................................................................................................
N-Ethylamphetamine ...............................................................................................................................................................
N-Hydroxy-3,4-methylenedioxyamphetamine ..........................................................................................................................
Noracymethadol .......................................................................................................................................................................
Norlevorphanol .........................................................................................................................................................................
Normethadone .........................................................................................................................................................................
Normorphine ............................................................................................................................................................................
Para-fluorofentanyl ...................................................................................................................................................................
Phenomorphan ........................................................................................................................................................................
Pholcodine ...............................................................................................................................................................................
Psilocybin .................................................................................................................................................................................
Psilocyn ....................................................................................................................................................................................
Tetrahydrocannabinols ............................................................................................................................................................
Thiofentanyl .............................................................................................................................................................................
Tilidine ......................................................................................................................................................................................
Trimeperidine ...........................................................................................................................................................................
2g
2g
2g
2g
2g
52 g
2g
18 g
2g
2g
2g
2g
2g
393,000 g
2g
10 g
2g
Established 2011
quotas
Basic class—Schedule II
1-Phenylcyclohexylamine ........................................................................................................................................................
1-piperdinocyclohexanecarbonitrile .........................................................................................................................................
4-Anilino-N-phenethyl-4-piperidine (ANPP) .............................................................................................................................
Alfentanil ..................................................................................................................................................................................
Alphaprodine ............................................................................................................................................................................
Amobarbital ..............................................................................................................................................................................
Amphetamine (for conversion) ................................................................................................................................................
Amphetamine (for sale) ...........................................................................................................................................................
Cocaine ....................................................................................................................................................................................
Codeine (for conversion) .........................................................................................................................................................
Codeine (for sale) ....................................................................................................................................................................
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 ...................................................................................................................................................................
2g
2g
2,500,000 g
8,000 g
2g
40,007 g
7,500,000 g
18,600,000 g
247,000 g
65,000,000 g
39,605,000 g
92,000,000 g
800,000 g
827,000 g
83,000 g
2g
1,428,000 g
2g
55,000,000 g
3,455,000 g
11 g
3g
5g
10,000 g
9,000,000 g
6,600,000 g
3g
7g
3g
5g
20,000,000 g
26,000,000 g
3,130,000 g
jlentini on DSKJ8SOYB1PROD with NOTICES
[750,000 grams of levo-desoxyephedrine for use in a non-controlled, non-prescription product; 2,331,000 grams for methamphetamine mostly
for conversion to a schedule III product; and 49,000 grams for methamphetamine (for sale)]
Methylphenidate .......................................................................................................................................................................
Morphine (for conversion) ........................................................................................................................................................
Morphine (for sale) ..................................................................................................................................................................
Nabilone ...................................................................................................................................................................................
Noroxymorphone (for conversion) ...........................................................................................................................................
Noroxymorphone (for sale) ......................................................................................................................................................
Opium (powder) .......................................................................................................................................................................
Opium (tincture) .......................................................................................................................................................................
Oripavine ..................................................................................................................................................................................
Oxycodone (for conversion) ....................................................................................................................................................
Oxycodone (for sale) ...............................................................................................................................................................
Oxymorphone (for conversion) ................................................................................................................................................
Oxymorphone (for sale) ...........................................................................................................................................................
Pentobarbital ............................................................................................................................................................................
Phenazocine ............................................................................................................................................................................
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17:18 Dec 17, 2010
Jkt 223001
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E:\FR\FM\20DEN1.SGM
20DEN1
50,000,000 g
83,000,000 g
39,000,000 g
10,502 g
9,000,000 g
401,000 g
230,000 g
1,500,000 g
15,000,000 g
5,600,000 g
105,500,000 g
12,800,000 g
3,070,000 g
28,000,000 g
5g
79407
Federal Register / Vol. 75, No. 243 / Monday, December 20, 2010 / Notices
Established 2011
quotas
Basic class—Schedule II
jlentini on DSKJ8SOYB1PROD with NOTICES
Phencyclidine ...........................................................................................................................................................................
Phenmetrazine .........................................................................................................................................................................
Phenylacetone .........................................................................................................................................................................
Racemethorphan .....................................................................................................................................................................
Remifentanil .............................................................................................................................................................................
Secobarbital .............................................................................................................................................................................
Sufentanil .................................................................................................................................................................................
Tapentadol ...............................................................................................................................................................................
Thebaine ..................................................................................................................................................................................
The Deputy Administrator further
orders that aggregate production quotas
for all other schedules I and II
controlled substances included in 21
CFR 1308.11 and 1308.12 be established
at 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
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 $126,400,000 or more
in any one year, and will not
significantly or uniquely affect small
governments. Therefore, no actions were
deemed necessary under the provisions
VerDate Mar<15>2010
17:18 Dec 17, 2010
Jkt 223001
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: December 10, 2010.
Michele M. Leonhart,
Deputy Administrator.
[FR Doc. 2010–31849 Filed 12–17–10; 8:45 am]
BILLING CODE 4410–09–P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
24 g
2g
8,000,000 g
2g
2,500 g
260,002 g
7,000 g
1,000,000 g
126,000,000 g
Epidemic Act of 2005 (Title VII of
Pub. L. 109–177) (CMEA) amended
Section 306 of the Controlled
Substances Act (CSA) (21 U.S.C. 826) by
adding ephedrine, pseudoephedrine,
and phenylpropanolamine to existing
language to read as follows: ‘‘The
Attorney General shall determine the
total quantity and establish production
quotas for each basic class of controlled
substance in schedules I and II and for
ephedrine, pseudoephedrine, and
phenylpropanolamine to be
manufactured each calendar year to
provide for the estimated medical,
scientific, research, and industrial needs
of the United States, for lawful export
requirements, and for the establishment
and maintenance of reserve stocks.’’
Further, section 715 of the CMEA
amended 21 U.S.C. 952 ‘‘Importation of
Controlled Substances’’ by adding the
same List I chemicals to the existing
language in paragraph (a), and by
adding a new paragraph (d) to read as
follows:
This notice establishes the
initial 2011 Assessment of Annual
Needs for certain List I chemicals in
accordance with the Combat
Methamphetamine Epidemic Act of
2005 (CMEA).
DATES: Effective Date: December 20,
2010.
(a) Controlled substances in schedule I or
II and narcotic drugs in schedule III, IV, or
V; exceptions
It shall be unlawful to import into the
customs territory of the United States from
any place outside thereof (but within the
United States), or to import into the United
States from any place outside thereof, any
controlled substance in schedule I or II of
subchapter I of this chapter, or any narcotic
drug in schedule III, IV, or V of subchapter
I of this chapter, or ephedrine,
pseudoephedrine, and
phenylpropanolamine, except that—
(1) such amounts of crude opium, poppy
straw, concentrate of poppy straw, and coca
leaves, and of ephedrine, pseudoephedrine,
and phenylpropanolamine, as the Attorney
General finds to be necessary to provide for
medical, scientific, or other legitimate
purposes * * * may be so imported under
such regulations as the Attorney General
shall prescribe.
FOR FURTHER INFORMATION CONTACT:
*
Christine A. Sannerud, PhD, Chief, Drug
and Chemical Evaluation Section, Drug
Enforcement Administration, 8701
Morrissette Drive, Springfield, Virginia
22152, Telephone: (202) 307–7183.
SUPPLEMENTARY INFORMATION: Section
713 of the Combat Methamphetamine
(d)(1) With respect to a registrant under
section 958 who is authorized under
subsection (a)(1) to import ephedrine,
pseudoephedrine, or phenylpropanolamine,
at any time during the year the registrant may
apply for an increase in the amount of such
chemical that the registrant is authorized to
import, and the Attorney General may
[Docket No. DEA–350E]
Established Assessment of Annual
Needs for the List I Chemicals
Ephedrine, Pseudoephedrine, and
Phenylpropanolamine for 2011
Drug Enforcement
Administration (DEA), Justice.
ACTION: Notice of Assessment of Annual
Needs for 2011.
AGENCY:
SUMMARY:
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E:\FR\FM\20DEN1.SGM
*
*
20DEN1
*
*
]]>Agencies
[Federal Register Volume 75, Number 243 (Monday, December 20, 2010)]
[Notices]
[Pages 79404-79407]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-31849]
-----------------------------------------------------------------------
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[DEA 343E]
Controlled Substances: Established Initial Aggregate Production
Quotas for 2011
AGENCY: Drug Enforcement Administration (DEA), Justice.
ACTION: Notice of aggregate production quotas for 2011.
-----------------------------------------------------------------------
SUMMARY: This notice establishes initial 2011 aggregate production
quotas for controlled substances in schedules I and II of the
Controlled Substances Act (CSA).
DATES: Effective Date: December 20, 2010.
FOR FURTHER INFORMATION CONTACT: Christine A. Sannerud, PhD, Chief,
Drug & Chemical Evaluation Section, Drug Enforcement Administration,
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 to 28 CFR 0.104.
The 2011 aggregate production quotas represent those quantities of
controlled substances that may be produced in the United States in 2011
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 September 15, 2010, a notice of the proposed initial 2011
aggregate production quotas for certain controlled substances in
schedules I and II was published in the Federal Register (75 FR 56137).
All interested persons were invited to comment on or object to these
proposed aggregate production quotas on or before October 15, 2010.
Seven responses (six from DEA registered manufacturers, and one
from a non-DEA registrant) were received within the published comment
period, offering comments on a total of 31 schedules I and II
controlled substances. The commenters stated that the proposed
aggregate production quotas for 3,4-methylenedioxyamphetamine, 3,4-
methylenedioxy-N-ethylamphetamine, 3,4-methylenedioxymethamphetamine,
4-anilino-N-phenethyl-4-piperidine, amphetamine (for sale), cathinone,
codeine (for sale), dihydromorphine, fentanyl, gamma hydroxybutyric
acid, heroin, hydrocodone, hydromorphone, marihuana, meperidine,
methaqualone, methylphenidate, morphine (for conversion), morphine (for
sale), nabilone, noroxymorphone (for conversion), opium (tincture),
oxycodone (for sale), pentobarbital, phencyclidine, remifentanil,
secobarbital, tapentadol, tetrahydrocannabinols, thebaine and tilidine
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 2010 factors, including 2010
manufacturing quotas, current 2010 sales and inventories, 2011 export
requirements, additional applications received, as well as research and
product development requirements. Based on this information, DEA has
adjusted the initial aggregate production quotas for 3,4-
methylenedioxyamphetamine, 3,4-methylenedioxy-N-ethylamphetamine, 3,4-
methylenedioxymethamphetamine, amobarbital, cathinone,
dimethyltryptamine, ibogaine, lysergic
[[Page 79405]]
acid diethylamide, metazocine, methaqualone, nabilone, normorphine,
noroxymorphone (for sale), phenazocine, phencyclidine, secobarbital,
and tetrahydrocannabinols to meet the legitimate needs of the United
States.
Regarding 4-anilino-N-phenethyl-4-piperidine, amphetamine (for
sale), codeine (for sale), dihydromorphine, fentanyl, gamma
hydroxybutyric acid, heroin, hydrocodone, hydromorphone, marihuana,
meperidine, methylphenidate, morphine (for conversion), morphine (for
sale), noroxymorphone (for conversion), opium (tincture), oxycodone
(for sale), pentobarbital, remifentanil, tapentadol, thebaine and
tilidine DEA has determined that the proposed initial 2011 aggregate
production quotas are sufficient to meet the current 2011 estimated
medical, scientific, research, and industrial needs of the United
States.
Pursuant to 21 CFR 1303, the Deputy Administrator of DEA will, in
2011, adjust aggregate production quotas and individual manufacturing
quotas allocated for the year based upon 2010 year-end inventory and
actual 2010 disposition data supplied by quota recipients for each
basic class of schedule I or II controlled substance.
Therefore, under the authority vested in the Attorney General by
Section 306 of the CSA (21 U.S.C. 826), and delegated to the
Administrator of 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 2011 initial aggregate production quotas for the
following controlled substances, expressed in grams of anhydrous acid
or base, be established as follows:
------------------------------------------------------------------------
Basic class--Schedule I Established 2011 quotas
------------------------------------------------------------------------
1-Methyl-4-phenyl-4- 2 g
propionoxypiperidine.
2,5-Dimethoxyamphetamine............ 2 g
2,5-Dimethoxy-4-ethylamphetamine 2 g
(DOET).
2,5-Dimethoxy-4-n- 2 g
propylthiophenethylamine.
3-Methylfentanyl.................... 2 g
3-Methylthiofentanyl................ 2 g
3,4-Methylenedioxyamphetamine (MDA). 22 g
3,4-Methylenedioxy-N- 15 g
ethylamphetamine (MDEA).
3,4-Methylenedioxymethamphetamine 22 g
(MDMA).
3,4,5-Trimethoxyamphetamine......... 2 g
4-Bromo-2,5-dimethoxyamphetamine 2 g
(DOB).
4-Bromo-2,5-dimethoxyphenethylamine 2 g
(2-CB).
4-Methoxyamphetamine................ 77 g
4-Methylaminorex.................... 2 g
4-Methyl-2,5-dimethoxyamphetamine 2 g
(DOM).
5-Methoxy-3,4- 2 g
methylenedioxyamphetamine.
5-Methoxy-N,N-diisopropyltryptamine. 2 g
Acetyl-alpha-methylfentanyl......... 2 g
Acetyldihydrocodeine................ 2 g
Acetylmethadol...................... 2 g
Allylprodine........................ 2 g
Alphacetylmethadol.................. 2 g
Alpha-ethyltryptamine............... 2 g
Alphameprodine...................... 2 g
Alphamethadol....................... 2 g
Alpha-methylfentanyl................ 2 g
Alpha-methylthiofentanyl............ 2 g
Alpha-methyltryptamine (AMT)........ 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........................... 4 g
Codeine-N-oxide..................... 602 g
Diethyltryptamine................... 2 g
Difenoxin........................... 3,000 g
Dihydromorphine..................... 3,608,000 g
Dimethyltryptamine.................. 7 g
Gamma-hydroxybutyric acid........... 3,000,000 g
Heroin.............................. 20 g
Hydromorphinol...................... 2 g
Hydroxypethidine.................... 2 g
Ibogaine............................ 5 g
Lysergic acid diethylamide (LSD).... 16 g
Marihuana........................... 21,000 g
Mescaline........................... 5 g
Methaqualone........................ 10 g
Methcathinone....................... 4 g
Methyldihydromorphine............... 2 g
Morphine-N-oxide.................... 605 g
[[Page 79406]]
N-Benzylpiperazine.................. 2 g
N,N-Dimethylamphetamine............. 2 g
N-Ethylamphetamine.................. 2 g
N-Hydroxy-3,4- 2 g
methylenedioxyamphetamine.
Noracymethadol...................... 2 g
Norlevorphanol...................... 52 g
Normethadone........................ 2 g
Normorphine......................... 18 g
Para-fluorofentanyl................. 2 g
Phenomorphan........................ 2 g
Pholcodine.......................... 2 g
Psilocybin.......................... 2 g
Psilocyn............................ 2 g
Tetrahydrocannabinols............... 393,000 g
Thiofentanyl........................ 2 g
Tilidine............................ 10 g
Trimeperidine....................... 2 g
------------------------------------------------------------------------
------------------------------------------------------------------------
Basic class--Schedule II Established 2011 quotas
------------------------------------------------------------------------
1-Phenylcyclohexylamine............. 2 g
1-piperdinocyclohexanecarbonitrile.. 2 g
4-Anilino-N-phenethyl-4-piperidine 2,500,000 g
(ANPP).
Alfentanil.......................... 8,000 g
Alphaprodine........................ 2 g
Amobarbital......................... 40,007 g
Amphetamine (for conversion)........ 7,500,000 g
Amphetamine (for sale).............. 18,600,000 g
Cocaine............................. 247,000 g
Codeine (for conversion)............ 65,000,000 g
Codeine (for sale).................. 39,605,000 g
Dextropropoxyphene.................. 92,000,000 g
Dihydrocodeine...................... 800,000 g
Diphenoxylate....................... 827,000 g
Ecgonine............................ 83,000 g
Ethylmorphine....................... 2 g
Fentanyl............................ 1,428,000 g
Glutethimide........................ 2 g
Hydrocodone (for sale).............. 55,000,000 g
Hydromorphone....................... 3,455,000 g
Isomethadone........................ 11 g
Levo-alphacetylmethadol (LAAM)...... 3 g
Levomethorphan...................... 5 g
Levorphanol......................... 10,000 g
Lisdexamfetamine.................... 9,000,000 g
Meperidine.......................... 6,600,000 g
Meperidine Intermediate-A........... 3 g
Meperidine Intermediate-B........... 7 g
Meperidine Intermediate-C........... 3 g
Metazocine.......................... 5 g
Methadone (for sale)................ 20,000,000 g
Methadone Intermediate.............. 26,000,000 g
Methamphetamine..................... 3,130,000 g
------------------------------------------------------------------------
[750,000 grams of levo-desoxyephedrine for use in a non-controlled, non-
prescription product; 2,331,000 grams for methamphetamine mostly for
conversion to a schedule III product; and 49,000 grams for
methamphetamine (for sale)]
------------------------------------------------------------------------
Methylphenidate..................... 50,000,000 g
Morphine (for conversion)........... 83,000,000 g
Morphine (for sale)................. 39,000,000 g
Nabilone............................ 10,502 g
Noroxymorphone (for conversion)..... 9,000,000 g
Noroxymorphone (for sale)........... 401,000 g
Opium (powder)...................... 230,000 g
Opium (tincture).................... 1,500,000 g
Oripavine........................... 15,000,000 g
Oxycodone (for conversion).......... 5,600,000 g
Oxycodone (for sale)................ 105,500,000 g
Oxymorphone (for conversion)........ 12,800,000 g
Oxymorphone (for sale).............. 3,070,000 g
Pentobarbital....................... 28,000,000 g
Phenazocine......................... 5 g
[[Page 79407]]
Phencyclidine....................... 24 g
Phenmetrazine....................... 2 g
Phenylacetone....................... 8,000,000 g
Racemethorphan...................... 2 g
Remifentanil........................ 2,500 g
Secobarbital........................ 260,002 g
Sufentanil.......................... 7,000 g
Tapentadol.......................... 1,000,000 g
Thebaine............................ 126,000,000 g
------------------------------------------------------------------------
The Deputy Administrator further orders that aggregate production
quotas for all other schedules I and II controlled substances included
in 21 CFR 1308.11 and 1308.12 be established at 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 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
$126,400,000 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: December 10, 2010.
Michele M. Leonhart,
Deputy Administrator.
[FR Doc. 2010-31849 Filed 12-17-10; 8:45 am]
BILLING CODE 4410-09-P
