Controlled Substances: Final Revised Aggregate Production Quotas for 2006, 61803-61806 [E6-17524]
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Federal Register / Vol. 71, No. 202 / Thursday, October 19, 2006 / Notices
cprice-sewell on PROD1PC66 with NOTICES
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 any 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
quotas for ephedrine, pseudoephedrine,
and phenylpropanolamine is mandated
by law. 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
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 §§ 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 $118,000,000 or more
in any one year, and will not
significantly or uniquely affect small
governments. Therefore, no actions were
deemed necessary under the provisions
of the Unfunded Mandates Reform Act
of 1995.
This action is not a major rule as
defined by § 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: October 13, 2006.
Michele M. Leonhart,
Deputy Administrator.
[FR Doc. E6–17526 Filed 10–18–06; 8:45 am]
BILLING CODE 4410–09–P
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA–270F]
Controlled Substances: Final Revised
Aggregate Production Quotas for 2006
Drug Enforcement
Administration (DEA), U.S. Department
of Justice.
ACTION: Notice of final aggregate
production quotas for 2006.
AGENCY:
SUMMARY: This notice establishes final
2006 aggregate production quotas for
controlled substances in Schedules I
and II of the Controlled Substances Act
of 1970 (CSA). The DEA has taken into
consideration comments received in
response to a notice of the proposed
revised aggregate production quotas for
2006 published July 5, 2006 (71 FR
38174).
EFFECTIVE DATE: October 19, 2006.
FOR FURTHER INFORMATION CONTACT:
Christine A. Sannerud, PhD, Chief, Drug
and Chemical Evaluation Section, Drug
Enforcement Administration,
Washington, DC 20537, Telephone:
(202) 307–7183.
SUPPLEMENTARY INFORMATION: Section
306 of the CSA (Title 21 United States
Code (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 Code of Federal Regulations
(CFR) 0.100. The Administrator, in turn,
has redelegated this function to the
Deputy Administrator, pursuant to 28
CFR 0.104.
The 2006 aggregate production quotas
represent those quantities of controlled
substances in Schedules I and II that
may be produced in the United States in
2006 to provide adequate supplies of
each substance for: the estimated
medical, scientific, research and
industrial needs of the United States;
lawful export requirements; and the
establishment and maintenance of
reserve stocks (21 U.S.C. 826(a) and 21
CFR 1303.11). These quotas do not
include imports of controlled
substances.
On July 5, 2006, a notice of the
proposed revised 2006 aggregate
production quotas for certain controlled
substances in Schedules I and II was
published in the Federal Register (71
FR 38174). All interested persons were
invited to comment on or object to these
proposed aggregate production quotas
on or before July 26, 2006.
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61803
Eight companies commented on a
total of 22 Schedules I and II controlled
substances within the published
comment period. Eight companies
proposed that the aggregate production
quotas for alfentanil, amphetamine,
codeine (for conversion),
dihydrocodeine, dihydromorphine,
diphenoxylate, fentanyl, gamma
hydroxybutyric acid, hydrocodone,
hydromorphinol, hydromorphone,
methadone, methylphenidate, morphine
(for conversion), N,Ndimethylamphetamine, opium,
oxycodone, oxycodone (for conversion),
oxymorphone, oxymorphone (for
conversion), tetrahydrocannabinols, and
thebaine were insufficient to provide for
the estimated medical, scientific,
research, and industrial needs of the
United States, for export requirements
and for the establishment and
maintenance of reserve stocks.
DEA has taken into consideration the
above comments along with the relevant
2005 year-end inventories, initial 2006
manufacturing quotas, 2006 export
requirements, actual and projected 2006
sales, research, product development
requirements and additional
applications received. Based on this
information, the DEA has adjusted the
final 2006 aggregate production quotas
for alfentanil, codeine (for conversion),
dextropropoxyphene, dihydromorphine,
hydrocodone, hydromorphone,
morphine (for conversion), N,Ndimethylamphetamine, opium,
oxycodone, oxycodone (for conversion),
oxymorphone, oxymorphone (for
conversion), tetrahydrocannabinols, and
thebaine to meet the legitimate needs of
the United States.
Regarding amphetamine,
dihydrocodeine, diphenoxylate,
fentanyl, gamma hydroxybutyric acid,
hydromorphinol, methadone, and
methylphenidate, the DEA has
determined that the proposed revised
2006 aggregate production quotas are
sufficient to meet the current 2006
estimated medical, scientific, research,
and industrial needs of the United
States and to provide for adequate
inventories.
Therefore, under the authority vested
in the Attorney General by Section 306
of the CSA (21 U.S.C. 826), and
delegated to the Administrator of the
DEA by 28 CFR 0.100, and redelegated
to the Deputy Administrator, pursuant
to 28 CFR 0.104, the Deputy
Administrator hereby orders that the
2006 final aggregate production quotas
for the following controlled substances,
expressed in grams of anhydrous acid or
base, be established as follows:
E:\FR\FM\19OCN1.SGM
19OCN1
61804
Federal Register / Vol. 71, No. 202 / Thursday, October 19, 2006 / Notices
Final revised
2006 quotas
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 ......................................................................................................................................................................
g 4–Methylaminorex ............................................................................................................................................................................
4–Methyl-2,5-dimethoxyamphetamine (DOM) .....................................................................................................................................
5–Methoxy-3,4-methylenedioxyamphetamine .....................................................................................................................................
Acetyl-alpha-methylfentanyl .................................................................................................................................................................
Acetyldihydrocodeine ...........................................................................................................................................................................
Acetylmethadol ....................................................................................................................................................................................
Allylprodine ..........................................................................................................................................................................................
Alphacetylmethadol ..............................................................................................................................................................................
Alpha-ethyltryptamine ..........................................................................................................................................................................
Alphameprodine ...................................................................................................................................................................................
Alphamethadol .....................................................................................................................................................................................
Alpha-methylfentanyl ...........................................................................................................................................................................
Alpha-methylthiofentanyl ......................................................................................................................................................................
Aminorex ..............................................................................................................................................................................................
Benzylmorphine ...................................................................................................................................................................................
Betacetylmethadol ...............................................................................................................................................................................
Beta-hydroxy-3-methylfentanyl ............................................................................................................................................................
Beta-hydroxyfentanyl ...........................................................................................................................................................................
Betameprodine .....................................................................................................................................................................................
Betamethadol .......................................................................................................................................................................................
Betaprodine ..........................................................................................................................................................................................
Bufotenine ............................................................................................................................................................................................
Cathinone .............................................................................................................................................................................................
Codeine-N-oxide ..................................................................................................................................................................................
Diethyltryptamine .................................................................................................................................................................................
Difenoxin ..............................................................................................................................................................................................
Dihydromorphine ..................................................................................................................................................................................
Dimethyltryptamine ..............................................................................................................................................................................
Gamma-hydroxybutyric acid ................................................................................................................................................................
Heroin ..................................................................................................................................................................................................
Hydromorphinol ....................................................................................................................................................................................
Hydroxypethidine .................................................................................................................................................................................
Lysergic acid diethylamide (LSD) ........................................................................................................................................................
Marihuana ............................................................................................................................................................................................
Mescaline .............................................................................................................................................................................................
Methaqualone ......................................................................................................................................................................................
Methcathinone .....................................................................................................................................................................................
Methyldihydromorphine ........................................................................................................................................................................
Morphine-N-oxide ................................................................................................................................................................................
N,N-Dimethylamphetamine ..................................................................................................................................................................
N-Ethylamphetamine ...........................................................................................................................................................................
N-Hydroxy-3,4-methylenedioxyamphetamine ......................................................................................................................................
Noracymethadol ...................................................................................................................................................................................
Norlevorphanol .....................................................................................................................................................................................
Normethadone .....................................................................................................................................................................................
Normorphine ........................................................................................................................................................................................
Para-fluorofentanyl ...............................................................................................................................................................................
Phenomorphan ....................................................................................................................................................................................
Pholcodine ...........................................................................................................................................................................................
Psilocybin .............................................................................................................................................................................................
Psilocyn ................................................................................................................................................................................................
Tetrahydrocannabinols ........................................................................................................................................................................
Thiofentanyl .........................................................................................................................................................................................
Trimeperidine .......................................................................................................................................................................................
cprice-sewell on PROD1PC66 with NOTICES
Basic class—schedule I
2,801,000
2
2
2
20
10
22
2
2
2
77
2
12
2
2
2
2
2
2
2
2
3
2
2
2
2
2
2
2
2
2
2
5
3
302
2
5,000
2,449,000
3
8,000,000
5
2
2
61
4,500,000
2
10
4
2
310
7
2
2
2
52
2
16
2
2
2
7
7
338,000
2
2
Final revised
2006 quotas
Basic class—schedule II
1–Phenylcyclohexylamine ................................................................................................................................................................
Alfentanil ..........................................................................................................................................................................................
Alphaprodine ....................................................................................................................................................................................
Amobarbital ......................................................................................................................................................................................
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E:\FR\FM\19OCN1.SGM
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2
7,200
2
101,000
g
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g
g
Federal Register / Vol. 71, No. 202 / Thursday, October 19, 2006 / Notices
61805
Basic class—schedule II
Final revised
2006 quotas
Amphetamine ...................................................................................................................................................................................
Cocaine ............................................................................................................................................................................................
Codeine (for sale) ............................................................................................................................................................................
Codeine (for conversion) .................................................................................................................................................................
Dextropropoxyphene ........................................................................................................................................................................
Dihydrocodeine ................................................................................................................................................................................
Diphenoxylate ..................................................................................................................................................................................
Ecgonine ..........................................................................................................................................................................................
Ethylmorphine ..................................................................................................................................................................................
Fentanyl ...........................................................................................................................................................................................
Glutethimide .....................................................................................................................................................................................
Hydrocodone (for sale) ....................................................................................................................................................................
Hydrocodone (for conversion) .........................................................................................................................................................
Hydromorphone ...............................................................................................................................................................................
Isomethadone ..................................................................................................................................................................................
Levo-alphacetylmethadol (LAAM) ....................................................................................................................................................
Levomethorphan ..............................................................................................................................................................................
Levorphanol .....................................................................................................................................................................................
Meperidine .......................................................................................................................................................................................
Metazocine .......................................................................................................................................................................................
Methadone (for sale) .......................................................................................................................................................................
Methadone Intermediate ..................................................................................................................................................................
Methamphetamine ...........................................................................................................................................................................
17,000,000
286,000
39,605,000
59,000,000
120,000,000
1,261,000
828,000
83,000
2
1,428,000
2
42,000,000
1,500,000
2,500,000
2
6
5
5,000
9,753,000
1
25,000,000
26,000,000
3,130,000
g
g
g
g
g
g
g
g
g
g
g
g
g
g
g
g
g
g
g
g
g
g
g
[680,000 grams of levo-desoxyephedrine for use in a non-controlled, non prescription product; 2,405,000 grams for methamphetamine mostly
for conversion to a Schedule III product; and 45,000 grams for methamphetamine (for sale)]
cprice-sewell on PROD1PC66 with NOTICES
Methylphenidate ...............................................................................................................................................................................
Morphine (for sale) ..........................................................................................................................................................................
Morphine (for conversion) ................................................................................................................................................................
Nabilone ...........................................................................................................................................................................................
Noroxymorphone (for sale) ..............................................................................................................................................................
Noroxymorphone (for conversion) ...................................................................................................................................................
Opium ..............................................................................................................................................................................................
Oxycodone (for sale) .......................................................................................................................................................................
Oxycodone (for conversion) ............................................................................................................................................................
Oxymorphone ..................................................................................................................................................................................
Oxymorphone (for conversion) ........................................................................................................................................................
Pentobarbital ....................................................................................................................................................................................
Phencyclidine ...................................................................................................................................................................................
Phenmetrazine .................................................................................................................................................................................
Racemethorphan .............................................................................................................................................................................
Remifentanil .....................................................................................................................................................................................
Secobarbital .....................................................................................................................................................................................
Sufentanil .........................................................................................................................................................................................
Thebaine ..........................................................................................................................................................................................
The Deputy Administrator further
orders that the aggregate production
quotas for all other Schedules I and II
controlled substances included in 21
CFR 1308.11 and 1308.12 shall be zero.
The Office of Management and Budget
has determined that notices of aggregate
production quotas are not subject to
centralized review under Executive
Order (E.O.) 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 E.O. 13132.
The Deputy Administrator hereby
certifies that this action will have no
significant impact upon small entities
VerDate Aug<31>2005
14:50 Oct 18, 2006
Jkt 211001
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
PO 00000
Frm 00100
Fmt 4703
Sfmt 4703
35,000,000
35,000,000
100,000,000
2
1,002
5,600,000
1,360,000
56,000,000
4,610,000
806,000
2,400,000
28,000,000
2,021
2
2
2,700
2
6,500
78,000,000
g
g
g
g
g
g
g
g
g
g
g
g
g
g
g
g
g
g
g
3(b)(2) of E.O. 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 $118,000,000 or more
in any one year, and will not
significantly or uniquely affect small
governments. Therefore, no actions were
deemed necessary under the provisions
of the Unfunded Mandates Reform Act
of 1995.
This action is not a major rule as
defined by Section 804 of the Small
Business Regulatory Enforcement
Fairness Act of 1996. This action will
not result in an annual effect on the
economy of $100,000,000 or more; a
major increase in costs or prices; or
significant adverse effects on
competition, employment, investment,
productivity, innovation, or on the
E:\FR\FM\19OCN1.SGM
19OCN1
61806
Federal Register / Vol. 71, No. 202 / Thursday, October 19, 2006 / Notices
ability of United States-based
companies to compete with foreignbased companies in domestic and
export markets.
Dated: October 13, 2006.
Michele M. Leonhart,
Deputy Administrator.
[FR Doc. E6–17524 Filed 10–18–06; 8:45 am]
BILLING CODE 4410–09–P
NUCLEAR REGULATORY
COMMISSION
[Docket No. 50–255]
cprice-sewell on PROD1PC66 with NOTICES
Nuclear Management Company, LLC,
Palisades Nuclear Plant; Notice of
Availability of the Final Supplement 27
to the Generic Environmental Impact
Statement for License Renewal of
Nuclear Plants, Regarding the License
Renewal of Palisades Nuclear Plant
Notice is hereby given that the U.S.
Nuclear Regulatory Commission (NRC,
Commission) has published a final
plant-specific supplement to the
‘‘Generic Environmental Impact
Statement for License Renewal of
Nuclear Plants’’ (GEIS), NUREG–1437,
regarding the renewal of operating
license DPR–20 for the Palisades
Nuclear Plant (Palisades) for an
additional 20 years of operation.
Palisades is located on the eastern shore
of Lake Michigan in Covert Township
on the western side of Van Buren
County, Michigan, approximately 4.5
miles south of the city limits of South
Haven, Michigan. Possible alternatives
to the proposed action (license renewal)
include no action and reasonable
alternative energy sources.
As discussed in Section 9.3 of the
final Supplement 27, based on: (1) The
analysis and findings in the GEIS; (2)
the Environmental Report submitted by
Nuclear Management Company, LLC; (3)
consultation with Federal, State, and
local agencies; (4) the staff’s own
independent review; and (5) the staff’s
consideration of public comments, the
recommendation of the staff is that the
Commission determine that the adverse
environmental impacts of license
renewal for Palisades are not so great
that preserving the option of license
renewal for energy-planning decision
makers would be unreasonable.
The final Supplement 27 to the GEIS
is publicly available at the NRC Public
Document Room (PDR), located at One
White Flint North, 11555 Rockville
Pike, Rockville, Maryland, or from the
NRC’s Agencywide Documents Access
and Management System (ADAMS). The
ADAMS Public Electronic Reading
Room is accessible at https://
VerDate Aug<31>2005
14:50 Oct 18, 2006
Jkt 211001
adamswebsearch.nrc.gov/dologin.htm.
The Accession Number for the final
Supplement 27 to the GEIS is
ML062710300. Persons who do not have
access to ADAMS, or who encounter
problems in accessing the documents
located in ADAMS, should contact the
NRC’s PDR reference staff by telephone
at 1–800–397–4209, or 301–415–4737,
or by e-mail at pdr@nrc.gov. In addition,
the South Haven Memorial Library, 314
Broadway Street, South Haven,
Michigan, has agreed to make the final
supplement 27 to the GEIS available for
public inspection.
FOR FURTHER INFORMATION, CONTACT: Mr.
Bo M. Pham, Environmental Branch B,
Division of License Renewal, Office of
Nuclear Reactor Regulation, U.S.
Nuclear Regulatory Commission,
Washington, DC, 20555–0001. Mr. Pham
may be contacted by telephone at 1–
800–368–5642, extension 8450 or via email at PalisadesEIS@nrc.gov.
Dated at Rockville, Maryland, this 12th day
of October, 2006.
For the Nuclear Regulatory Commission.
Bo M. Pham,
Acting Branch Chief, Environmental Branch
B, Division of License Renewal, Office of
Nuclear Reactor Regulation.
[FR Doc. E6–17435 Filed 10–18–06; 8:45 am]
BILLING CODE 7590–01–P
NUCLEAR REGULATORY
COMMISSION
Advisory Committee on Reactor
Safeguards; Meeting Notice
In accordance with the purposes of
sections 29 and 182b. of the Atomic
Energy Act (42 U.S.C. 2039, 2232b), the
Advisory Committee on Reactor
Safeguards (ACRS) will hold a meeting
on November 1–3, 2006, 11545
Rockville Pike, Rockville, Maryland.
The date of this meeting was previously
published in the Federal Register on
Tuesday, November 22, 2005 (70 FR
70638).
Wednesday, November 1, 2006,
Conference Room T–2B3, Two White
Flint North, Rockville, Maryland
8:30 a.m.–8:35 a.m.: Opening
Remarks by the ACRS Chairman
(Open)—The ACRS Chairman will make
opening remarks regarding the conduct
of the meeting.
8:35 a.m.–10 a.m.: Final Review of the
License Renewal Application for the
Palisades Nuclear Plant (Open)—The
Committee will hear presentations by
and hold discussions with
representatives of the NRC staff and the
Nuclear Management Company, LLC
regarding the license renewal
PO 00000
Frm 00101
Fmt 4703
Sfmt 4703
application for the Palisades Nuclear
Plant and the associated NRC staff’s
final Safety Evaluation Report.
10:15 a.m.–11:45 a.m.: Proposed
Revisions to Regulatory Guide 1.189,
‘‘Fire Protection for Operating Nuclear
Power Plants’’ (Open)—The Committee
will hear presentations by and hold
discussions with representatives of the
NRC staff regarding proposed revisions
to Regulatory Guide 1.189, and related
matters.
1:30 p.m.–3:30 p.m.: Draft Final Rule
to Risk-Inform 10 CFR 50.46,
‘‘Acceptance Criteria for Emergency
Core Cooling Systems for Light-Water
Nuclear Power Reactors’’ (Open)—The
Committee will hear presentations by
and hold discussions with
representatives of the NRC staff
regarding the draft final rule to riskinform 10 CFR 50.46, and related
matters.
3:45 p.m.–4:45 p.m.: Proposed
Revisions to Regulatory Guides and
Standard Review Plan (SRP) Sections in
Support of New Reactor Licensing
(Open)—The Committee will discuss
the proposed revisions to Regulatory
Guides and SRP Sections that are being
made in support of new reactor
licensing.
5 p.m.–7 p.m.: Preparation of ACRS
Reports (Open)—The Committee will
discuss proposed ACRS reports on
matters considered during this meeting.
Thursday, November 2, 2006,
Conference Room T–2B3, Two White
Flint North, Rockville, Maryland
8:30 a.m.–8:35 a.m.: Opening
Remarks by the ACRS Chairman
(Open)—The ACRS Chairman will make
opening remarks regarding the conduct
of the meeting.
8:35 a.m.–10 a.m.: Potential
Collaborative Research on Human
Reliability Analysis Methods (Open)—
The Committee will hear presentations
by and hold discussions with
representatives of the NRC staff
regarding potential collaborative
research on human reliability analysis
methods.
10:15 a.m.–11:15 a.m.: Future ACRS
Activities/Report of the Planning and
Procedures Subcommittee (Open)—The
Committee will discuss the
recommendations of the Planning and
Procedures Subcommittee regarding
items proposed for consideration by the
full Committee during future meetings.
Also, it will hear a report of the
Planning and Procedures Subcommittee
on matters related to the conduct of
ACRS business, including anticipated
workload and member assignments.
11:15 a.m.–11:30 a.m.: Reconciliation
of ACRS Comments and
E:\FR\FM\19OCN1.SGM
19OCN1
Agencies
[Federal Register Volume 71, Number 202 (Thursday, October 19, 2006)]
[Notices]
[Pages 61803-61806]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E6-17524]
-----------------------------------------------------------------------
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA-270F]
Controlled Substances: Final Revised Aggregate Production Quotas
for 2006
AGENCY: Drug Enforcement Administration (DEA), U.S. Department of
Justice.
ACTION: Notice of final aggregate production quotas for 2006.
-----------------------------------------------------------------------
SUMMARY: This notice establishes final 2006 aggregate production quotas
for controlled substances in Schedules I and II of the Controlled
Substances Act of 1970 (CSA). The DEA has taken into consideration
comments received in response to a notice of the proposed revised
aggregate production quotas for 2006 published July 5, 2006 (71 FR
38174).
EFFECTIVE DATE: October 19, 2006.
FOR FURTHER INFORMATION CONTACT: Christine A. Sannerud, PhD, Chief,
Drug and Chemical Evaluation Section, Drug Enforcement Administration,
Washington, DC 20537, Telephone: (202) 307-7183.
SUPPLEMENTARY INFORMATION: Section 306 of the CSA (Title 21 United
States Code (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 Code of Federal
Regulations (CFR) 0.100. The Administrator, in turn, has redelegated
this function to the Deputy Administrator, pursuant to 28 CFR 0.104.
The 2006 aggregate production quotas represent those quantities of
controlled substances in Schedules I and II that may be produced in the
United States in 2006 to provide adequate supplies of each substance
for: the estimated medical, scientific, research and industrial needs
of the United States; lawful export requirements; and the establishment
and maintenance of reserve stocks (21 U.S.C. 826(a) and 21 CFR
1303.11). These quotas do not include imports of controlled substances.
On July 5, 2006, a notice of the proposed revised 2006 aggregate
production quotas for certain controlled substances in Schedules I and
II was published in the Federal Register (71 FR 38174). All interested
persons were invited to comment on or object to these proposed
aggregate production quotas on or before July 26, 2006.
Eight companies commented on a total of 22 Schedules I and II
controlled substances within the published comment period. Eight
companies proposed that the aggregate production quotas for alfentanil,
amphetamine, codeine (for conversion), dihydrocodeine, dihydromorphine,
diphenoxylate, fentanyl, gamma hydroxybutyric acid, hydrocodone,
hydromorphinol, hydromorphone, methadone, methylphenidate, morphine
(for conversion), N,N-dimethylamphetamine, opium, oxycodone, oxycodone
(for conversion), oxymorphone, oxymorphone (for conversion),
tetrahydrocannabinols, and thebaine were insufficient to provide for
the estimated medical, scientific, research, and industrial needs of
the United States, for export requirements and for the establishment
and maintenance of reserve stocks.
DEA has taken into consideration the above comments along with the
relevant 2005 year-end inventories, initial 2006 manufacturing quotas,
2006 export requirements, actual and projected 2006 sales, research,
product development requirements and additional applications received.
Based on this information, the DEA has adjusted the final 2006
aggregate production quotas for alfentanil, codeine (for conversion),
dextropropoxyphene, dihydromorphine, hydrocodone, hydromorphone,
morphine (for conversion), N,N-dimethylamphetamine, opium, oxycodone,
oxycodone (for conversion), oxymorphone, oxymorphone (for conversion),
tetrahydrocannabinols, and thebaine to meet the legitimate needs of the
United States.
Regarding amphetamine, dihydrocodeine, diphenoxylate, fentanyl,
gamma hydroxybutyric acid, hydromorphinol, methadone, and
methylphenidate, the DEA has determined that the proposed revised 2006
aggregate production quotas are sufficient to meet the current 2006
estimated medical, scientific, research, and industrial needs of the
United States and to provide for adequate inventories.
Therefore, under the authority vested in the Attorney General by
Section 306 of the CSA (21 U.S.C. 826), and delegated to the
Administrator of the DEA by 28 CFR 0.100, and redelegated to the Deputy
Administrator, pursuant to 28 CFR 0.104, the Deputy Administrator
hereby orders that the 2006 final aggregate production quotas for the
following controlled substances, expressed in grams of anhydrous acid
or base, be established as follows:
[[Page 61804]]
------------------------------------------------------------------------
Final revised
Basic class--schedule I 2006 quotas
------------------------------------------------------------------------
2,5-Dimethoxyamphetamine................................ 2,801,000 g
2,5-Dimethoxy-4-ethylamphetamine (DOET)................. 2 g
3-Methylfentanyl........................................ 2 g
3-Methylthiofentanyl.................................... 2 g
3,4-Methylenedioxyamphetamine (MDA)..................... 20 g
3,4-Methylenedioxy-N-ethylamphetamine (MDEA)............ 10 g
3,4-Methylenedioxymethamphetamine (MDMA)................ 22 g
3,4,5-Trimethoxyamphetamine............................. 2 g
4-Bromo-2,5-dimethoxyamphetamine (DOB).................. 2 g
4-Bromo-2,5-dimethoxyphenethylamine (2-CB).............. 2 g
4-Methoxyamphetamine.................................... 77 g
g 4-Methylaminorex...................................... 2 g
4-Methyl-2,5-dimethoxyamphetamine (DOM)................. 12 g
5-Methoxy-3,4-methylenedioxyamphetamine................. 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........................................... 3 g
Alpha-methylfentanyl.................................... 2 g
Alpha-methylthiofentanyl................................ 2 g
Aminorex................................................ 2 g
Benzylmorphine.......................................... 2 g
Betacetylmethadol....................................... 2 g
Beta-hydroxy-3-methylfentanyl........................... 2 g
Beta-hydroxyfentanyl.................................... 2 g
Betameprodine........................................... 2 g
Betamethadol............................................ 2 g
Betaprodine............................................. 2 g
Bufotenine.............................................. 5 g
Cathinone............................................... 3 g
Codeine-N-oxide......................................... 302 g
Diethyltryptamine....................................... 2 g
Difenoxin............................................... 5,000 g
Dihydromorphine......................................... 2,449,000 g
Dimethyltryptamine...................................... 3 g
Gamma-hydroxybutyric acid............................... 8,000,000 g
Heroin.................................................. 5 g
Hydromorphinol.......................................... 2 g
Hydroxypethidine........................................ 2 g
Lysergic acid diethylamide (LSD)........................ 61 g
Marihuana............................................... 4,500,000 g
Mescaline............................................... 2 g
Methaqualone............................................ 10 g
Methcathinone........................................... 4 g
Methyldihydromorphine................................... 2 g
Morphine-N-oxide........................................ 310 g
N,N-Dimethylamphetamine................................. 7 g
N-Ethylamphetamine...................................... 2 g
N-Hydroxy-3,4-methylenedioxyamphetamine................. 2 g
Noracymethadol.......................................... 2 g
Norlevorphanol.......................................... 52 g
Normethadone............................................ 2 g
Normorphine............................................. 16 g
Para-fluorofentanyl..................................... 2 g
Phenomorphan............................................ 2 g
Pholcodine.............................................. 2 g
Psilocybin.............................................. 7 g
Psilocyn................................................ 7 g
Tetrahydrocannabinols................................... 338,000 g
Thiofentanyl............................................ 2 g
Trimeperidine........................................... 2 g
------------------------------------------------------------------------
------------------------------------------------------------------------
Final revised
Basic class--schedule II 2006 quotas
------------------------------------------------------------------------
1-Phenylcyclohexylamine............................... 2 g
Alfentanil............................................ 7,200 g
Alphaprodine.......................................... 2 g
Amobarbital........................................... 101,000 g
[[Page 61805]]
Amphetamine........................................... 17,000,000 g
Cocaine............................................... 286,000 g
Codeine (for sale).................................... 39,605,000 g
Codeine (for conversion).............................. 59,000,000 g
Dextropropoxyphene.................................... 120,000,000 g
Dihydrocodeine........................................ 1,261,000 g
Diphenoxylate......................................... 828,000 g
Ecgonine.............................................. 83,000 g
Ethylmorphine......................................... 2 g
Fentanyl.............................................. 1,428,000 g
Glutethimide.......................................... 2 g
Hydrocodone (for sale)................................ 42,000,000 g
Hydrocodone (for conversion).......................... 1,500,000 g
Hydromorphone......................................... 2,500,000 g
Isomethadone.......................................... 2 g
Levo-alphacetylmethadol (LAAM)........................ 6 g
Levomethorphan........................................ 5 g
Levorphanol........................................... 5,000 g
Meperidine............................................ 9,753,000 g
Metazocine............................................ 1 g
Methadone (for sale).................................. 25,000,000 g
Methadone Intermediate................................ 26,000,000 g
Methamphetamine....................................... 3,130,000 g
------------------------------------------------------------------------
[680,000 grams of levo-desoxyephedrine for use in a non-controlled, non
prescription product; 2,405,000 grams for methamphetamine mostly for
conversion to a Schedule III product; and 45,000 grams for
methamphetamine (for sale)]
------------------------------------------------------------------------
Methylphenidate....................................... 35,000,000 g
Morphine (for sale)................................... 35,000,000 g
Morphine (for conversion)............................. 100,000,000 g
Nabilone.............................................. 2 g
Noroxymorphone (for sale)............................. 1,002 g
Noroxymorphone (for conversion)....................... 5,600,000 g
Opium................................................. 1,360,000 g
Oxycodone (for sale).................................. 56,000,000 g
Oxycodone (for conversion)............................ 4,610,000 g
Oxymorphone........................................... 806,000 g
Oxymorphone (for conversion).......................... 2,400,000 g
Pentobarbital......................................... 28,000,000 g
Phencyclidine......................................... 2,021 g
Phenmetrazine......................................... 2 g
Racemethorphan........................................ 2 g
Remifentanil.......................................... 2,700 g
Secobarbital.......................................... 2 g
Sufentanil............................................ 6,500 g
Thebaine.............................................. 78,000,000 g
------------------------------------------------------------------------
The Deputy Administrator further orders that the aggregate
production quotas for all other Schedules I and II controlled
substances included in 21 CFR 1308.11 and 1308.12 shall be zero.
The Office of Management and Budget has determined that notices of
aggregate production quotas are not subject to centralized review under
Executive Order (E.O.) 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 E.O. 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 E.O. 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
$118,000,000 or more in any one year, and will not significantly or
uniquely affect small governments. Therefore, no actions were deemed
necessary under the provisions of the Unfunded Mandates Reform Act of
1995.
This action is not a major rule as defined by Section 804 of the
Small Business Regulatory Enforcement Fairness Act of 1996. This action
will not result in an annual effect on the economy of $100,000,000 or
more; a major increase in costs or prices; or significant adverse
effects on competition, employment, investment, productivity,
innovation, or on the
[[Page 61806]]
ability of United States-based companies to compete with foreign-based
companies in domestic and export markets.
Dated: October 13, 2006.
Michele M. Leonhart,
Deputy Administrator. 1
[FR Doc. E6-17524 Filed 10-18-06; 8:45 am]
BILLING CODE 4410-09-P