Controlled Substances: Proposed Revised Aggregate Production Quotas for 2010, 35838-35841 [2010-15159]
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35838
Federal Register / Vol. 75, No. 120 / Wednesday, June 23, 2010 / Notices
Dated: June 8, 2010.
Mark J. Musaus,
Acting Regional Director.
[FR Doc. 2010–15168 Filed 6–22–10; 8:45 am]
BILLING CODE 4310–55–P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA–318R]
Controlled Substances: Proposed
Revised Aggregate Production Quotas
for 2010
AGENCY: Drug Enforcement
Administration (DEA), Justice.
ACTION: Notice of proposed revised 2010
aggregate production quotas.
SUMMARY: This notice proposes revised
2010 aggregate production quotas for
controlled substances in schedules I and
II of the Controlled Substances Act
(CSA).
DATES: Written comments must be
postmarked, and electronic comments
must be sent, on or before July 23, 2010.
ADDRESSES: To ensure proper handling
of comments, please reference ‘‘Docket
No. DEA–318R’’ on all written and
electronic correspondence. Written
comments should be sent to the DEA
Headquarters, Attention: DEA Federal
Register Representative/ODL, 8701
Morrissette Drive, Springfield, VA
22152. Comments may be directly sent
to DEA electronically by sending an
electronic message to
dea.diversion.policy@usdoj.gov. An
electronic copy of this document is also
available at the https://
www.regulations.gov Web site.
However, persons wishing to request a
hearing should note that such requests
must be written and manually signed;
requests for a hearing will not be
accepted via electronic means. DEA will
accept attachments to electronic
comments in Microsoft Word,
WordPerfect, Adobe PDF, or Excel file
formats only. DEA will not accept any
file format other than those specifically
listed here.
FOR FURTHER INFORMATION CONTACT:
Christine A. Sannerud, PhD, Chief, Drug
and Chemical Evaluation Section, Drug
Enforcement Administration, 8701
Morrissette Drive, Springfield, VA
22152, Telephone: (202) 307–7183.
SUPPLEMENTARY INFORMATION: Section
306 of the CSA (21 U.S.C. 826) requires
that the Attorney General establish
aggregate production quotas for each
basic class of controlled substance listed
in schedules I and II. This responsibility
has been delegated to the Administrator
of the DEA by 28 CFR 0.100. The
Administrator in turn, has redelegated
this function to the Deputy
Administrator, pursuant to 28 CFR
0.104.
On May 21, 2009, a notice of
proposed 2010 aggregate production
quotas for certain controlled substances
in schedules I and II was published in
the Federal Register (74 FR 23881). This
notice stipulated that the DEA would
adjust the quotas in 2010 as provided
for in 21 CFR part 1303. The 2010
established aggregate production quotas
were published in the Federal Register
(74 FR 54080) on October 21, 2010.
The proposed revised 2010 aggregate
production quotas represent those
quantities of controlled substances in
schedules I and II 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.
These quotas do not include imports of
controlled substances for use in
industrial processes.
The proposed revisions are based on
a review of 2009 year-end inventories,
2009 disposition data submitted by
quota applicants, estimates of the
medical needs of the United States,
product development, and other
information available to the DEA.
Therefore, under the authority vested
in the Attorney General by Section 306
of the CSA (21 U.S.C. 826), and
delegated to the Administrator of the
DEA by 28 CFR 0.100, and redelegated
to the Deputy Administrator pursuant to
28 CFR 0.104, the Deputy Administrator
hereby proposes the following revised
2010 aggregate production quotas for the
following controlled substances,
expressed in grams of anhydrous acid or
base:
Previously
established initial
2010 quotas
Basic class
Proposed revised
2010 quotas
mstockstill on DSKH9S0YB1PROD with NOTICES
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 ..............................................................................................................................
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35839
Federal Register / Vol. 75, No. 120 / Wednesday, June 23, 2010 / Notices
Previously
established initial
2010 quotas
Basic class
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 ........................................................................................................................................
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 ...............................................................................................................................................
Proposed revised
2010 quotas
2
2
2
2
2
2
2
2
2
3
3
602
2
3,000
3,300,000
3
24,200,000
20
2
2
1
15
4,500,000
7
7
4
2
605
2
7
2
2
2
52
2
16
2
2
2
7
7
312,500
2
2
g
g
g
g
g
g
g
g
g
g
g
g
g
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g
g
g
g
g
g
g
g
2
2
2
2
2
2
2
2
2
3
3
602
2
3,000
3,500,000
3
52,156,000
20
2
2
1
15
11,000
5
7
4
2
605
2
2
2
2
2
52
2
16
2
2
2
2
2
216,000
2
2
g
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g
g
g
g
g
g
g
g
g
g
g
g
g
g
2
2
8,000
2
3
17,000,000
6,500,000
247,000
39,605,000
65,000,000
106,000,000
1,200,000
947,000
83,000
2
1,428,000
2
55,000,000
3,300,000
11
3
5
10,000
9,000,000
8,600,000
g
g
g
g
g
g
g
g
g
g
g
g
g
g
g
g
g
g
g
g
g
g
g
g
g
2
0
6,300
2
3
17,000,000
6,500,000
247,000
39,605,000
65,000,000
92,000,000
800,000
627,000
83,000
2
1,428,000
2
55,000,000
3,455,000
11
3
5
10,000
9,000,000
6,600,000
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mstockstill on DSKH9S0YB1PROD with NOTICES
Schedule II
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 ...................................................................................................................................................
VerDate Mar<15>2010
16:17 Jun 22, 2010
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E:\FR\FM\23JNN1.SGM
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35840
Federal Register / Vol. 75, No. 120 / Wednesday, June 23, 2010 / Notices
Previously
established initial
2010 quotas
Basic class
Meperidine Intermediate-A ..........................................................................................................................
Meperidine Intermediate-B ..........................................................................................................................
Meperidine Intermediate-C ..........................................................................................................................
Metazocine ...................................................................................................................................................
Methadone (for sale) ...................................................................................................................................
Methadone Intermediate ..............................................................................................................................
Methamphetamine .......................................................................................................................................
3
7
3
1
25,000,000
26,000,000
3,130,000
g
g
g
g
g
g
g
Proposed revised
2010 quotas
3
7
3
1
20,000,000
26,000,000
3,130,000
g
g
g
g
g
g
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)]
mstockstill on DSKH9S0YB1PROD with NOTICES
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 ..............................................................................................................................................
Oxymorphone (for conversion) ....................................................................................................................
Pentobarbital ................................................................................................................................................
Phenazocine ................................................................................................................................................
Phencyclidine ...............................................................................................................................................
Phenmetrazine .............................................................................................................................................
Phenylacetone .............................................................................................................................................
Racemethorphan .........................................................................................................................................
Remifentanil .................................................................................................................................................
Secobarbital .................................................................................................................................................
Sufentanil .....................................................................................................................................................
Thebaine ......................................................................................................................................................
The Deputy Administrator further
proposes that aggregate production
quotas for all other schedules I and II
controlled substances included in 21
CFR 1308.11 and 1308.12 remain at
zero.
All interested persons are invited to
submit their comments in writing or
electronically regarding this proposal
following the procedures in the
ADDRESSES section of this document. A
person may object to or comment on the
proposal relating to any of the abovementioned substances without filing
comments or objections regarding the
others. If a person believes that one or
more of these issues warrant a hearing,
the individual should so state and
summarize the reasons for this belief.
Persons wishing to request a hearing
should note that such requests must be
written and manually signed; requests
for a hearing will not be accepted via
electronic means. In the event that
comments or objections to this proposal
raise one or more issues which the
Deputy Administrator finds warrant a
hearing, the Deputy Administrator shall
order a public hearing by notice in the
Federal Register, summarizing the
VerDate Mar<15>2010
16:17 Jun 22, 2010
Jkt 220001
issues to be heard and setting the time
for the hearing as per 21 CFR 1303.13(c).
Regulatory Certifications
Regulatory Flexibility Act
The Deputy Administrator hereby
certifies that this action will not have a
significant economic impact upon small
entities whose interests must be
considered under the Regulatory
Flexibility Act, 5 U.S.C. 601–612. The
establishment of aggregate production
quotas for schedules I and II controlled
substances is mandated by law and by
international treaty obligations. The
quotas are necessary to provide for the
estimated medical, scientific, research
and industrial needs of the United
States, for lawful export requirements,
and the establishment and maintenance
of reserve stocks. While aggregate
production quotas are of primary
importance to large manufacturers, their
impact upon small entities is neither
negative nor beneficial. Accordingly, the
Deputy Administrator has determined
that this action does not require a
regulatory flexibility analysis.
PO 00000
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50,000,000
35,000,000
100,000,000
9,002
10,000
9,000,000
230,000
1,050,000
15,000,000
88,000,000
4,000,000
2,570,000
12,000,000
28,000,000
1
20
2
12,500,001
2
500
67,000
10,300
126,000,000
g
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50,000,000
35,000,000
83,000,000
9,002
5,000
9,000,000
230,000
1,050,000
15,000,000
88,000,000
4,000,000
2,570,000
12,000,000
28,000,000
1
14
2
12,500,001
2
2,500
67,000
7,000
126,000,000
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Executive Order 12866
The Office of Management and Budget
has determined that notices of aggregate
production quotas are not subject to
centralized review under Executive
Order 12866.
Executive Order 13132
This action does not preempt or
modify any provision of state law; nor
does it impose enforcement
responsibilities on any state; nor does it
diminish the power of any state to
enforce its own laws. Accordingly, this
action does not have federalism
implications warranting the application
of Executive Order 13132.
Executive Order 12988
This action meets the applicable
standards set forth in Sections 3(a) and
3(b)(2) of Executive Order 12988 Civil
Justice Reform.
Unfunded Mandates Reform Act of
1995
This action will not result in the
expenditure by State, local, and tribal
governments, in the aggregate, or by the
private sector, of $126,000,000 or more
(adjusted for inflation) in any one year,
E:\FR\FM\23JNN1.SGM
23JNN1
Federal Register / Vol. 75, No. 120 / Wednesday, June 23, 2010 / Notices
and will not significantly or uniquely
affect small governments. Therefore, no
actions were deemed necessary under
the provisions of the Unfunded
Mandates Reform Act of 1995.
Congressional Review Act
This action is not a major rule as
defined by Section 804 of the Small
Business Regulatory Enforcement
Fairness Act of 1996 (Congressional
Review Act). This action will not result
in an annual effect on the economy of
$100,000,000 or more; a major increase
in costs or prices; or significant adverse
effects on competition, employment,
investment, productivity, innovation, or
on the ability of United States-based
companies to compete with foreignbased companies in domestic and
export markets.
Dated: June 17, 2010.
Michele M. Leonhart,
Deputy Administrator.
[FR Doc. 2010–15159 Filed 6–22–10; 8:45 am]
BILLING CODE 4410–09–P
DEPARTMENT OF LABOR
Employee Benefits Security
Administration
Proposed Extension of Information
Collection Request Submitted for
Public Comment; Prohibited
Transaction Class Exemption 91–55—
Transactions Between Individual
Retirement Accounts and Authorized
Purchasers of American Eagle Coins
mstockstill on DSKH9S0YB1PROD with NOTICES
AGENCY: Employee Benefits Security
Administration, Department of Labor.
ACTION: Notice.
SUMMARY: The Department of Labor (the
Department), in accordance with the
Paperwork Reduction Act of 1995 (PRA
95) (44 U.S.C. 3506(c)(2)(A)), provides
the general public and Federal agencies
with an opportunity to comment on
proposed and continuing collections of
information. This helps the Department
assess the impact of its information
collection requirements and minimize
the reporting burden on the public and
helps the public understand the
Department’s information collection
requirements and provide the requested
data in the desired format. Currently,
the Employee Benefits Security
Administration is soliciting comments
on the proposed extension of the
information collection provisions of
Prohibited Transaction Class Exemption
91–55. A copy of the information
collection request (ICR) may be obtained
by contacting the office listed in the
ADDRESSES section of this notice.
VerDate Mar<15>2010
16:17 Jun 22, 2010
Jkt 220001
35841
DATES: Written comments must be
submitted to the office shown in the
Addresses section on or before August
23, 2010.
ADDRESSES: G. Christopher Cosby,
Department of Labor, Employee Benefits
Security Administration, 200
Constitution Avenue, NW., Washington,
DC 20210, (202) 693–8410, FAX (202)
693–4745 (these are not toll-free
numbers).
SUPPLEMENTARY INFORMATION:
make findings under section 408 of
ERISA and section 4975(c) of the Code.
The confirmation and disclosure
requirements protect a participant or
beneficiary who invests in IRAs and
transacts in Coins with authorized
purchasers by providing the investor or
the person directing his or her
investments with timely information
about the market in Coins and about the
individual’s account in particular.
I. Background
Prohibited Transaction Exemption
91–55 permits purchases and sales by
certain ‘‘individual retirement
accounts,’’ as defined in Internal
Revenue Code section 408 (IRAs) of
American Eagle bullion coins (‘‘Coins’’)
in principal transactions from or to
broker-dealers in Coins that are
‘‘authorized purchasers’’ of Coins in bulk
quantities from the United States Mint
and which are also ‘‘disqualified
persons,’’ within the meaning of Code
section 4975(e)(2), with respect to IRAs.
The exemption also describes the
circumstances under which an interestfree extension of credit in connection
with such sales and purchases is
permitted. In the absence of an
exemption, such purchases and sales
and extensions of credit would be
impermissible under the Employee
Retirement Income Security Act of 1974
(ERISA).
Among other conditions, the
exemption requires certain information
related to covered transactions in Coins
must be disclosed by the authorized
purchaser to persons who direct the
transaction for the IRA. Currently, it is
standard industry practice that most of
this information is provided to persons
directing investments in an IRA when
transactions in Coins occur. The
exemption also requires that the
disqualified person maintain for a
period of at least six years such records
as are necessary to allow accredited
persons, as defined in the exemption, to
determine whether the conditions of the
transaction have been met. Finally, an
authorized purchaser must provide a
confirmation statement with respect to
each covered transaction to the person
who directs the transaction for the IRA.
The requirements constitute information
collections within the meaning of the
PRA, for which the Department has
obtained approval from the Office of
Management and Budget (OMB) under
OMB Control No. 1210–0079. The OMB
approval is currently scheduled to
expire on August 31, 2010.
The recordkeeping requirement
facilitates the Department’s ability to
This notice requests public comment
pertaining to the Department’s request
for extension of OMB approval of the
information collection contained in PTE
91–55. After considering comments
received in response to this notice, the
Department intends to submit an ICR to
OMB for continuing approval. No
change to the existing ICR is proposed
or made at this time. An agency may not
conduct or sponsor, and a person is not
required to respond to, an information
collection unless it displays a valid
OMB control number. A summary of the
ICR and the current burden estimates
follows:
Agency: Employee Benefits Security
Administration, Department of Labor.
Title: Prohibited Transaction Class
Exemption 91–55.
Type of Review: Extension of a
currently approved collection of
information.
OMB Number: 1210–0079.
Affected Public: Individuals or
households; Business or other for-profit;
Not-for-profit institutions.
Respondents: 3.
Responses: 663,431.
Frequency: On occasion.
Estimated Total Burden Hours:
11,063.
Estimated Total Burden Cost:
$152,589.
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II. Current Actions
III. Focus of Comments
The Department of Labor
(Department) is particularly interested
in comments that:
• Evaluate whether the proposed
collection of information is necessary
for the proper performance of the
functions of the agency, including
whether the information will have
practical utility;
• Evaluate the accuracy of the
agency’s estimate of the burden of the
proposed collection of information,
including the validity of the
methodology and assumptions used;
• Enhance the quality, utility, and
clarity of the information to be
collected; and
• Minimize the burden of the
collection of information on those who
are to respond, including through the
E:\FR\FM\23JNN1.SGM
23JNN1
Agencies
[Federal Register Volume 75, Number 120 (Wednesday, June 23, 2010)]
[Notices]
[Pages 35838-35841]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-15159]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA-318R]
Controlled Substances: Proposed Revised Aggregate Production
Quotas for 2010
AGENCY: Drug Enforcement Administration (DEA), Justice.
ACTION: Notice of proposed revised 2010 aggregate production quotas.
-----------------------------------------------------------------------
SUMMARY: This notice proposes revised 2010 aggregate production quotas
for controlled substances in schedules I and II of the Controlled
Substances Act (CSA).
DATES: Written comments must be postmarked, and electronic comments
must be sent, on or before July 23, 2010.
ADDRESSES: To ensure proper handling of comments, please reference
``Docket No. DEA-318R'' on all written and electronic correspondence.
Written comments should be sent to the DEA Headquarters, Attention: DEA
Federal Register Representative/ODL, 8701 Morrissette Drive,
Springfield, VA 22152. Comments may be directly sent to DEA
electronically by sending an electronic message to
dea.diversion.policy@usdoj.gov. An electronic copy of this document is
also available at the https://www.regulations.gov Web site. However,
persons wishing to request a hearing should note that such requests
must be written and manually signed; requests for a hearing will not be
accepted via electronic means. DEA will accept attachments to
electronic comments in Microsoft Word, WordPerfect, Adobe PDF, or Excel
file formats only. DEA will not accept any file format other than those
specifically listed here.
FOR FURTHER INFORMATION CONTACT: Christine A. Sannerud, PhD, Chief,
Drug and Chemical Evaluation Section, Drug Enforcement Administration,
8701 Morrissette Drive, Springfield, VA 22152, Telephone: (202) 307-
7183.
SUPPLEMENTARY INFORMATION: Section 306 of the CSA (21 U.S.C. 826)
requires that the Attorney General establish aggregate production
quotas for each basic class of controlled substance listed in schedules
I and II. This responsibility has been delegated to the Administrator
of the DEA by 28 CFR 0.100. The Administrator in turn, has redelegated
this function to the Deputy Administrator, pursuant to 28 CFR 0.104.
On May 21, 2009, a notice of proposed 2010 aggregate production
quotas for certain controlled substances in schedules I and II was
published in the Federal Register (74 FR 23881). This notice stipulated
that the DEA would adjust the quotas in 2010 as provided for in 21 CFR
part 1303. The 2010 established aggregate production quotas were
published in the Federal Register (74 FR 54080) on October 21, 2010.
The proposed revised 2010 aggregate production quotas represent
those quantities of controlled substances in schedules I and II 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.
These quotas do not include imports of controlled substances for use in
industrial processes.
The proposed revisions are based on a review of 2009 year-end
inventories, 2009 disposition data submitted by quota applicants,
estimates of the medical needs of the United States, product
development, and other information available to the DEA.
Therefore, under the authority vested in the Attorney General by
Section 306 of the CSA (21 U.S.C. 826), and delegated to the
Administrator of the DEA by 28 CFR 0.100, and redelegated to the Deputy
Administrator pursuant to 28 CFR 0.104, the Deputy Administrator hereby
proposes the following revised 2010 aggregate production quotas for the
following controlled substances, expressed in grams of anhydrous acid
or base:
----------------------------------------------------------------------------------------------------------------
Previously
established Proposed revised
Basic class initial 2010 2010 quotas
quotas
----------------------------------------------------------------------------------------------------------------
Schedule I
----------------------------------------------------------------------------------------------------------------
2,5-Dimethoxyamphetamine.................................................. 2 g 2 g
2,5-Dimethoxy-4-ethylamphetamine (DOET)................................... 2 g 2 g
3-Methylfentanyl.......................................................... 2 g 2 g
3-Methylthiofentanyl...................................................... 2 g 2 g
3,4-Methylenedioxyamphetamine (MDA)....................................... 25 g 20 g
3,4-Methylenedioxy-N-ethylamphetamine (MDEA).............................. 10 g 10 g
3,4-Methylenedioxymethamphetamine (MDMA).................................. 20 g 20 g
3,4,5-Trimethoxyamphetamine............................................... 2 g 2 g
4-Bromo-2,5-dimethoxyamphetamine (DOB).................................... 2 g 2 g
4-Bromo-2,5-dimethoxyphenethylamine (2-CB)................................ 2 g 2 g
4-Methoxyamphetamine...................................................... 77 g 77 g
4-Methylaminorex.......................................................... 2 g 2 g
4-Methyl-2,5-dimethoxyamphetamine (DOM)................................... 2 g 2 g
5-Methoxy-3,4-methylenedioxyamphetamine................................... 2 g 2 g
5-Methoxy-N,N-diisopropyltryptamine....................................... 5 g 0 g
Acetyl-alpha-methylfentanyl............................................... 2 g 2 g
Acetyldihydrocodeine...................................................... 2 g 2 g
Acetylmethadol............................................................ 2 g 2 g
Allylprodine.............................................................. 2 g 2 g
Alphacetylmethadol........................................................ 2 g 2 g
Alpha-ethyltryptamine..................................................... 2 g 2 g
Alphameprodine............................................................ 2 g 2 g
Alphamethadol............................................................. 2 g 2 g
Alpha-methylfentanyl...................................................... 2 g 2 g
Alpha-methylthiofentanyl.................................................. 2 g 2 g
[[Page 35839]]
Alpha-methyltryptamine (AMT).............................................. 2 g 2 g
Aminorex.................................................................. 2 g 2 g
Benzylmorphine............................................................ 2 g 2 g
Betacetylmethadol......................................................... 2 g 2 g
Beta-hydroxy-3-methylfentanyl............................................. 2 g 2 g
Beta-hydroxyfentanyl...................................................... 2 g 2 g
Betameprodine............................................................. 2 g 2 g
Betamethadol.............................................................. 2 g 2 g
Betaprodine............................................................... 2 g 2 g
Bufotenine................................................................ 3 g 3 g
Cathinone................................................................. 3 g 3 g
Codeine-N-oxide........................................................... 602 g 602 g
Diethyltryptamine......................................................... 2 g 2 g
Difenoxin................................................................. 3,000 g 3,000 g
Dihydromorphine........................................................... 3,300,000 g 3,500,000 g
Dimethyltryptamine........................................................ 3 g 3 g
Gamma-hydroxybutyric acid................................................. 24,200,000 g 52,156,000 g
Heroin.................................................................... 20 g 20 g
Hydromorphinol............................................................ 2 g 2 g
Hydroxypethidine.......................................................... 2 g 2 g
Ibogaine.................................................................. 1 g 1 g
Lysergic acid diethylamide (LSD).......................................... 15 g 15 g
Marihuana................................................................. 4,500,000 g 11,000 g
Mescaline................................................................. 7 g 5 g
Methaqualone.............................................................. 7 g 7 g
Methcathinone............................................................. 4 g 4 g
Methyldihydromorphine..................................................... 2 g 2 g
Morphine-N-oxide.......................................................... 605 g 605 g
N-Benzylpiperazine........................................................ 2 g 2 g
N,N-Dimethylamphetamine................................................... 7 g 2 g
N-Ethylamphetamine........................................................ 2 g 2 g
N-Hydroxy-3,4-methylenedioxyamphetamine................................... 2 g 2 g
Noracymethadol............................................................ 2 g 2 g
Norlevorphanol............................................................ 52 g 52 g
Normethadone.............................................................. 2 g 2 g
Normorphine............................................................... 16 g 16 g
Para-fluorofentanyl....................................................... 2 g 2 g
Phenomorphan.............................................................. 2 g 2 g
Pholcodine................................................................ 2 g 2 g
Psilocybin................................................................ 7 g 2 g
Psilocyn.................................................................. 7 g 2 g
Tetrahydrocannabinols..................................................... 312,500 g 216,000 g
Thiofentanyl.............................................................. 2 g 2 g
Trimeperidine............................................................. 2 g 2 g
----------------------------------------------------------------------------------------------------------------
Schedule II
----------------------------------------------------------------------------------------------------------------
1-Phenylcyclohexylamine................................................... 2 g 2 g
1-Piperdinocyclohexanecarbonitrile........................................ 2 g 0 g
Alfentanil................................................................ 8,000 g 6,300 g
Alphaprodine.............................................................. 2 g 2 g
Amobarbital............................................................... 3 g 3 g
Amphetamine (for sale).................................................... 17,000,000 g 17,000,000 g
Amphetamine (for conversion).............................................. 6,500,000 g 6,500,000 g
Cocaine................................................................... 247,000 g 247,000 g
Codeine (for sale)........................................................ 39,605,000 g 39,605,000 g
Codeine (for conversion).................................................. 65,000,000 g 65,000,000 g
Dextropropoxyphene........................................................ 106,000,000 g 92,000,000 g
Dihydrocodeine............................................................ 1,200,000 g 800,000 g
Diphenoxylate............................................................. 947,000 g 627,000 g
Ecgonine.................................................................. 83,000 g 83,000 g
Ethylmorphine............................................................. 2 g 2 g
Fentanyl.................................................................. 1,428,000 g 1,428,000 g
Glutethimide.............................................................. 2 g 2 g
Hydrocodone (for sale).................................................... 55,000,000 g 55,000,000 g
Hydromorphone............................................................. 3,300,000 g 3,455,000 g
Isomethadone.............................................................. 11 g 11 g
Levo-alphacetylmethadol (LAAM)............................................ 3 g 3 g
Levomethorphan............................................................ 5 g 5 g
Levorphanol............................................................... 10,000 g 10,000 g
Lisdexamfetamine.......................................................... 9,000,000 g 9,000,000 g
Meperidine................................................................ 8,600,000 g 6,600,000 g
[[Page 35840]]
Meperidine Intermediate-A................................................. 3 g 3 g
Meperidine Intermediate-B................................................. 7 g 7 g
Meperidine Intermediate-C................................................. 3 g 3 g
Metazocine................................................................ 1 g 1 g
Methadone (for sale)...................................................... 25,000,000 g 20,000,000 g
Methadone Intermediate.................................................... 26,000,000 g 26,000,000 g
Methamphetamine........................................................... 3,130,000 g 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 50,000,000 g
Morphine (for sale)....................................................... 35,000,000 g 35,000,000 g
Morphine (for conversion)................................................. 100,000,000 g 83,000,000 g
Nabilone.................................................................. 9,002 g 9,002 g
Noroxymorphone (for sale)................................................. 10,000 g 5,000 g
Noroxymorphone (for conversion)........................................... 9,000,000 g 9,000,000 g
Opium (powder)............................................................ 230,000 g 230,000 g
Opium (tincture).......................................................... 1,050,000 g 1,050,000 g
Oripavine................................................................. 15,000,000 g 15,000,000 g
Oxycodone (for sale)...................................................... 88,000,000 g 88,000,000 g
Oxycodone (for conversion)................................................ 4,000,000 g 4,000,000 g
Oxymorphone............................................................... 2,570,000 g 2,570,000 g
Oxymorphone (for conversion).............................................. 12,000,000 g 12,000,000 g
Pentobarbital............................................................. 28,000,000 g 28,000,000 g
Phenazocine............................................................... 1 g 1 g
Phencyclidine............................................................. 20 g 14 g
Phenmetrazine............................................................. 2 g 2 g
Phenylacetone............................................................. 12,500,001 g 12,500,001 g
Racemethorphan............................................................ 2 g 2 g
Remifentanil.............................................................. 500 g 2,500 g
Secobarbital.............................................................. 67,000 g 67,000 g
Sufentanil................................................................ 10,300 g 7,000 g
Thebaine.................................................................. 126,000,000 g 126,000,000 g
----------------------------------------------------------------------------------------------------------------
The Deputy Administrator further proposes that aggregate production
quotas for all other schedules I and II controlled substances included
in 21 CFR 1308.11 and 1308.12 remain at zero.
All interested persons are invited to submit their comments in
writing or electronically regarding this proposal following the
procedures in the ADDRESSES section of this document. A person may
object to or comment on the proposal relating to any of the above-
mentioned substances without filing comments or objections regarding
the others. If a person believes that one or more of these issues
warrant a hearing, the individual should so state and summarize the
reasons for this belief. Persons wishing to request a hearing should
note that such requests must be written and manually signed; requests
for a hearing will not be accepted via electronic means. In the event
that comments or objections to this proposal raise one or more issues
which the Deputy Administrator finds warrant a hearing, the Deputy
Administrator shall order a public hearing by notice in the Federal
Register, summarizing the issues to be heard and setting the time for
the hearing as per 21 CFR 1303.13(c).
Regulatory Certifications
Regulatory Flexibility Act
The Deputy Administrator hereby certifies that this action will not
have a significant economic impact upon small entities whose interests
must be considered under the Regulatory Flexibility Act, 5 U.S.C. 601-
612. The establishment of aggregate production quotas for schedules I
and II controlled substances is mandated by law and by international
treaty obligations. The quotas are necessary to provide for the
estimated medical, scientific, research and industrial needs of the
United States, for lawful export requirements, and the establishment
and maintenance of reserve stocks. While aggregate production quotas
are of primary importance to large manufacturers, their impact upon
small entities is neither negative nor beneficial. Accordingly, the
Deputy Administrator has determined that this action does not require a
regulatory flexibility analysis.
Executive Order 12866
The Office of Management and Budget has determined that notices of
aggregate production quotas are not subject to centralized review under
Executive Order 12866.
Executive Order 13132
This action does not preempt or modify any provision of state law;
nor does it impose enforcement responsibilities on any state; nor does
it diminish the power of any state to enforce its own laws.
Accordingly, this action does not have federalism implications
warranting the application of Executive Order 13132.
Executive Order 12988
This action meets the applicable standards set forth in Sections
3(a) and 3(b)(2) of Executive Order 12988 Civil Justice Reform.
Unfunded Mandates Reform Act of 1995
This action will not result in the expenditure by State, local, and
tribal governments, in the aggregate, or by the private sector, of
$126,000,000 or more (adjusted for inflation) in any one year,
[[Page 35841]]
and will not significantly or uniquely affect small governments.
Therefore, no actions were deemed necessary under the provisions of the
Unfunded Mandates Reform Act of 1995.
Congressional Review Act
This action is not a major rule as defined by Section 804 of the
Small Business Regulatory Enforcement Fairness Act of 1996
(Congressional Review Act). This action will not result in an annual
effect on the economy of $100,000,000 or more; a major increase in
costs or prices; or significant adverse effects on competition,
employment, investment, productivity, innovation, or on the ability of
United States-based companies to compete with foreign-based companies
in domestic and export markets.
Dated: June 17, 2010.
Michele M. Leonhart,
Deputy Administrator.
[FR Doc. 2010-15159 Filed 6-22-10; 8:45 am]
BILLING CODE 4410-09-P