Controlled Substances: Proposed Revised Aggregate Production Quotas for 2006, 38174-38176 [E6-10467]
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38174
Federal Register / Vol. 71, No. 128 / Wednesday, July 5, 2006 / Notices
Total Annual Burden Hours: 2,000
hours.
Request for Comments
The Bureau of Indian Affairs solicits
comments in order to:
(1) Evaluate whether the proposed
collection of information is necessary
for the proper performance of the
functions of the bureau, including
whether the information will have
practical utility;
(2) Evaluate the bureau’s estimate of
the burden of the proposed collection of
information, including the validity of
the methodology and assumptions used;
(3) Enhance the quality, utility and
clarity of the information to be
collected; and
(4) Minimize the burden of the
collection of the information on those
who are to respond.
Please note that the Office of
Management and Budget has 60 days
after receipt in which to make a
decision but may make a decision after
30 days. Therefore, early submissions of
comments have a better chance of
receiving full consideration.
Dated: June 14, 2006.
Michael D. Olsen,
Acting Principal Deputy Assistant Secretary—
Indian Affairs.
[FR Doc. E6–10448 Filed 7–3–06; 8:45 am]
BILLING CODE 4310–4N–P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA–270R]
Controlled Substances: Proposed
Revised Aggregate Production Quotas
for 2006
Drug Enforcement
Administration (DEA), U.S. Department
of Justice.
ACTION: Notice of proposed revised 2006
aggregate production quotas.
AGENCY:
SUMMARY: This notice proposes revised
2006 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 26, 2006.
ADDRESSES: To ensure proper handling
of comments, please reference ‘‘Docket
No. DEA–270R on all written and
electronic correspondence. Written
comments being sent via regular mail
should be sent to the Deputy Assistant
Administrator, Office of Diversion
Control, Drug Enforcement
Administration, Washington, DC 20537,
Attention: DEA Federal Register
Representative/CCD. Written comments
sent via express mail should be sent to
DEA Headquarters, Attention: DEA
Federal Register Representative/CCD,
2401 Jefferson-Davis Highway,
Alexandria, VA 22301. Comments may
be directly sent to DEA electronically by
sending an electronic message to
dea.diversion.policy@usdoj.gov.
Comments may also be sent
electronically through https://
www.regulations.gov using the
electronic comment form provided on
that site. An electronic copy of this
document is also available at the
https://www.regulations.gov Web site.
DEA will accept attachments to
electronic comments in Microsoft Word,
WordPerfect, Adobe PDF, or Excel file
formats only. DEA will not accept any
file format other than those specifically
listed here.
FOR FURTHER INFORMATION CONTACT:
Christine A. Sannerud, Ph.D., Chief,
Drug and Chemical Evaluation Section,
Drug Enforcement Administration,
Washington, DC 20537, Telephone:
(202) 307–7183.
SUPPLEMENTARY INFORMATION: Section
306 of the CSA (21 U.S.C. 826) requires
that the Attorney General establish
aggregate production quotas for each
basic class of controlled substance listed
in Schedules I and II. This
responsibility has been delegated to the
Administrator of the DEA by 28 CFR
0.100. The Administrator in turn, has
redelegated this function to the Deputy
Administrator, pursuant to 28 CFR
0.104.
On December 9, 2005, DEA published
a notice of established initial 2006
aggregate production quotas for certain
controlled substances in Schedules I
and II (70 FR 73269). This notice
stipulated that the DEA would adjust
the quotas in early 2006 as provided for
in 21 CFR part 1303.
The proposed revised 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.
These quotas do not include imports of
controlled substances for use in
industrial processes.
The proposed revisions are based on
a review of 2005 year-end inventories,
2005 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 of 1970 (21 U.S.C. 826),
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
2006 aggregate production quotas for the
following controlled substances,
expressed in grams of anhydrous acid or
base:
rwilkins on PROD1PC63 with NOTICES
Previously established initial
2006 quotas
(grams)
Basic Class—Schedule I:
2,5–Dimethoxyamphetamine ............................................................................................................................
2,5–Dimethoxy-4-ethylamphetamine (DOET) ..................................................................................................
3–Methylfentanyl ...............................................................................................................................................
3–Methylthiofentanyl .........................................................................................................................................
3,4–Methylenedioxyamphetamine (MDA) ........................................................................................................
3,4–Methylenedioxy-N-ethylamphetamine (MDEA) .........................................................................................
3,4–Methylenedioxymethamphetamine (MDMA) .............................................................................................
3,4,5–Trimethoxyamphetamine ........................................................................................................................
4–Bromo-2,5-dimethoxyamphetamine (DOB) ..................................................................................................
4–Bromo-2,5-dimethoxyphenethylamine (2–CB) .............................................................................................
4–Methoxyamphetamine ..................................................................................................................................
4–Methylaminorex ............................................................................................................................................
VerDate Aug<31>2005
19:34 Jul 03, 2006
Jkt 205001
PO 00000
Frm 00047
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Sfmt 4703
E:\FR\FM\05JYN1.SGM
05JYN1
2,801,000
2
2
2
20
10
22
2
2
2
77
2
Proposed revised 2006
quotas
(grams)
2,801,000
2
2
2
20
10
22
2
2
2
77
2
Federal Register / Vol. 71, No. 128 / Wednesday, July 5, 2006 / Notices
rwilkins on PROD1PC63 with NOTICES
Previously established initial
2006 quotas
(grams)
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 ....................................................................................................................................................
Basic Class—Schedule II:
1-Phenylcyclohexylamine .................................................................................................................................
Alfentanil ...........................................................................................................................................................
Alphaprodine .....................................................................................................................................................
Amobarbital .......................................................................................................................................................
Amphetamine ....................................................................................................................................................
Cocaine .............................................................................................................................................................
Codeine (for sale) .............................................................................................................................................
Codeine (for conversion) ..................................................................................................................................
Dextropropoxyphene ........................................................................................................................................
Dihydrocodeine .................................................................................................................................................
Diphenoxylate ...................................................................................................................................................
Ecgonine ...........................................................................................................................................................
Ethylmorphine ...................................................................................................................................................
Fentanyl ............................................................................................................................................................
Glutethimide ......................................................................................................................................................
Hydrocodone (for sale) .....................................................................................................................................
Hydrocodone (for conversion) ..........................................................................................................................
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19:34 Jul 03, 2006
Jkt 205001
PO 00000
Frm 00048
Fmt 4703
Sfmt 4703
E:\FR\FM\05JYN1.SGM
05JYN1
38175
Proposed revised 2006
quotas
(grams)
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
1,826,000
3
8,000,000
5
2
2
61
4,500,000
2
10
4
2
310
2
2
2
2
52
2
16
2
2
2
7
7
312,500
2
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
1,826,000
3
8,000,000
5
2
2
61
4,500,000
2
10
4
2
310
2
2
2
2
52
2
16
2
2
2
7
7
312,500
2
2
2
5,000
2
101,000
17,000,000
286,000
39,605,000
55,000,000
167,365,000
1,261,000
828,000
83,000
2
1,428,000
2
41,252,000
1,500,000
2
5,000
2
101,000
17,000,000
286,000
39,605,000
55,000,000
167,365,000
1,261,000
828,000
83,000
2
1,428,000
2
41,252,000
1,500,000
38176
Federal Register / Vol. 71, No. 128 / Wednesday, July 5, 2006 / Notices
Previously established initial
2006 quotas
(grams)
rwilkins on PROD1PC63 with NOTICES
Hydromorphone ................................................................................................................................................
Isomethadone ...................................................................................................................................................
Levo-alphacetylmethadol (LAAM) ....................................................................................................................
Levomethorphan ...............................................................................................................................................
Levorphanol ......................................................................................................................................................
Meperidine ........................................................................................................................................................
Metazocine .......................................................................................................................................................
Methadone (for sale) ........................................................................................................................................
Methadone Intermediate ...................................................................................................................................
Methamphetamine ............................................................................................................................................
[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 ...............................................................................................................................................
Morphine (for sale) ...........................................................................................................................................
Morphine (for conversion) ................................................................................................................................
Nabilone ............................................................................................................................................................
Noroxymorphone (for sale) ...............................................................................................................................
Noroxymorphone (for conversion) ....................................................................................................................
Opium ...............................................................................................................................................................
Oxycodone (for sale) ........................................................................................................................................
Oxycodone (for conversion) .............................................................................................................................
Oxymorphone ...................................................................................................................................................
Pentobarbital .....................................................................................................................................................
Phencyclidine ....................................................................................................................................................
Phenmetrazine ..................................................................................................................................................
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.
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).
The Office of Management and Budget
has determined that notices of aggregate
production quotas are not subject to
centralized review under Executive
Order 12866.
VerDate Aug<31>2005
19:34 Jul 03, 2006
Jkt 205001
This action does not preempt or
modify any provision of state law; nor
does it impose enforcement
responsibilities on any state; nor does it
diminish the power of any state to
enforce its own laws. Accordingly, this
action does not have federalism
implications warranting the application
of Executive Order 13132.
The Deputy Administrator hereby
certifies that this action will not have a
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
PO 00000
Frm 00049
Fmt 4703
Sfmt 4703
Proposed revised 2006
quotas
(grams)
3,300,000
2
6
5
5,000
9,753,000
1
21,000,000
26,000,000
3,130,000
3,300,000
2
6
5
5,000
9,753,000
1
25,000,000
26,000,000
3,130,000
35,000,000
35,000,000
110,774,000
2
1,002
5,600,000
1,280,000
49,200,000
920,000
534,000
20,335,000
2,021
2
2
2,700
2
6,500
72,453,000
35,000,000
35,000,000
110,774,000
2
1,002
5,600,000
1,280,000
49,200,000
920,000
534,000
28,000,000
2,021
2
2
2,700
2
6,500
72,453,000
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 section 804 of the Small
Business Regulatory Enforcement
Fairness Act of 1996. This action will
not result in an annual effect on the
economy of $100,000,000 or more; a
major increase in costs or prices; or
significant adverse effects on
competition, employment, investment,
productivity, innovation, or on the
ability of United States-based
companies to compete with foreignbased companies in domestic and
export markets.
Dated: June 26, 2006.
Michele M. Leonhart,
Deputy Administrator.
[FR Doc. E6–10467 Filed 7–3–06; 8:45 am]
BILLING CODE 4410–09–P
E:\FR\FM\05JYN1.SGM
05JYN1
Agencies
[Federal Register Volume 71, Number 128 (Wednesday, July 5, 2006)]
[Notices]
[Pages 38174-38176]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E6-10467]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA-270R]
Controlled Substances: Proposed Revised Aggregate Production
Quotas for 2006
AGENCY: Drug Enforcement Administration (DEA), U.S. Department of
Justice.
ACTION: Notice of proposed revised 2006 aggregate production quotas.
-----------------------------------------------------------------------
SUMMARY: This notice proposes revised 2006 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 26, 2006.
ADDRESSES: To ensure proper handling of comments, please reference
``Docket No. DEA-270R on all written and electronic correspondence.
Written comments being sent via regular mail should be sent to the
Deputy Assistant Administrator, Office of Diversion Control, Drug
Enforcement Administration, Washington, DC 20537, Attention: DEA
Federal Register Representative/CCD. Written comments sent via express
mail should be sent to DEA Headquarters, Attention: DEA Federal
Register Representative/CCD, 2401 Jefferson-Davis Highway, Alexandria,
VA 22301. Comments may be directly sent to DEA electronically by
sending an electronic message to dea.diversion.policy@usdoj.gov.
Comments may also be sent electronically through https://
www.regulations.gov using the electronic comment form provided on that
site. An electronic copy of this document is also available at the
https://www.regulations.gov Web site. DEA will accept attachments to
electronic comments in Microsoft Word, WordPerfect, Adobe PDF, or Excel
file formats only. DEA will not accept any file format other than those
specifically listed here.
FOR FURTHER INFORMATION CONTACT: Christine A. Sannerud, Ph.D., Chief,
Drug and Chemical Evaluation Section, Drug Enforcement Administration,
Washington, DC 20537, Telephone: (202) 307-7183.
SUPPLEMENTARY INFORMATION: Section 306 of the CSA (21 U.S.C. 826)
requires that the Attorney General establish aggregate production
quotas for each basic class of controlled substance listed in Schedules
I and II. This responsibility has been delegated to the Administrator
of the DEA by 28 CFR 0.100. The Administrator in turn, has redelegated
this function to the Deputy Administrator, pursuant to 28 CFR 0.104.
On December 9, 2005, DEA published a notice of established initial
2006 aggregate production quotas for certain controlled substances in
Schedules I and II (70 FR 73269). This notice stipulated that the DEA
would adjust the quotas in early 2006 as provided for in 21 CFR part
1303.
The proposed revised 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.
These quotas do not include imports of controlled substances for use in
industrial processes.
The proposed revisions are based on a review of 2005 year-end
inventories, 2005 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 of 1970 (21 U.S.C. 826), 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 2006 aggregate production quotas for the
following controlled substances, expressed in grams of anhydrous acid
or base:
------------------------------------------------------------------------
Previously
established Proposed
initial 2006 revised 2006
quotas (grams) quotas (grams)
------------------------------------------------------------------------
Basic Class--Schedule I:
2,5-Dimethoxyamphetamine............ 2,801,000 2,801,000
2,5-Dimethoxy-4-ethylamphetamine 2 2
(DOET).............................
3-Methylfentanyl.................... 2 2
3-Methylthiofentanyl................ 2 2
3,4-Methylenedioxyamphetamine (MDA). 20 20
3,4-Methylenedioxy-N- 10 10
ethylamphetamine (MDEA)............
3,4-Methylenedioxymethamphetamine 22 22
(MDMA).............................
3,4,5-Trimethoxyamphetamine......... 2 2
4-Bromo-2,5-dimethoxyamphetamine 2 2
(DOB)..............................
4-Bromo-2,5-dimethoxyphenethylamine 2 2
(2-CB).............................
4-Methoxyamphetamine................ 77 77
4-Methylaminorex.................... 2 2
[[Page 38175]]
4-Methyl-2,5-dimethoxyamphetamine 12 12
(DOM)..............................
5-Methoxy-3,4- 2 2
methylenedioxyamphetamine..........
Acetyl-alpha-methylfentanyl......... 2 2
Acetyldihydrocodeine................ 2 2
Acetylmethadol...................... 2 2
Allylprodine........................ 2 2
Alphacetylmethadol.................. 2 2
Alpha-ethyltryptamine............... 2 2
Alphameprodine...................... 2 2
Alphamethadol....................... 3 3
Alpha-methylfentanyl................ 2 2
Alpha-methylthiofentanyl............ 2 2
Aminorex............................ 2 2
Benzylmorphine...................... 2 2
Betacetylmethadol................... 2 2
Beta-hydroxy-3-methylfentanyl....... 2 2
Beta-hydroxyfentanyl................ 2 2
Betameprodine....................... 2 2
Betamethadol........................ 2 2
Betaprodine......................... 2 2
Bufotenine.......................... 5 5
Cathinone........................... 3 3
Codeine-N-oxide..................... 302 302
Diethyltryptamine................... 2 2
Difenoxin........................... 5,000 5,000
Dihydromorphine..................... 1,826,000 1,826,000
Dimethyltryptamine.................. 3 3
Gamma-hydroxybutyric acid........... 8,000,000 8,000,000
Heroin.............................. 5 5
Hydromorphinol...................... 2 2
Hydroxypethidine.................... 2 2
Lysergic acid diethylamide (LSD).... 61 61
Marihuana........................... 4,500,000 4,500,000
Mescaline........................... 2 2
Methaqualone........................ 10 10
Methcathinone....................... 4 4
Methyldihydromorphine............... 2 2
Morphine-N-oxide.................... 310 310
N,N-Dimethylamphetamine............. 2 2
N-Ethylamphetamine.................. 2 2
N-Hydroxy-3,4- 2 2
methylenedioxyamphetamine..........
Noracymethadol...................... 2 2
Norlevorphanol...................... 52 52
Normethadone........................ 2 2
Normorphine......................... 16 16
Para-fluorofentanyl................. 2 2
Phenomorphan........................ 2 2
Pholcodine.......................... 2 2
Psilocybin.......................... 7 7
Psilocyn............................ 7 7
Tetrahydrocannabinols............... 312,500 312,500
Thiofentanyl........................ 2 2
Trimeperidine....................... 2 2
Basic Class--Schedule II:
1-Phenylcyclohexylamine............. 2 2
Alfentanil.......................... 5,000 5,000
Alphaprodine........................ 2 2
Amobarbital......................... 101,000 101,000
Amphetamine......................... 17,000,000 17,000,000
Cocaine............................. 286,000 286,000
Codeine (for sale).................. 39,605,000 39,605,000
Codeine (for conversion)............ 55,000,000 55,000,000
Dextropropoxyphene.................. 167,365,000 167,365,000
Dihydrocodeine...................... 1,261,000 1,261,000
Diphenoxylate....................... 828,000 828,000
Ecgonine............................ 83,000 83,000
Ethylmorphine....................... 2 2
Fentanyl............................ 1,428,000 1,428,000
Glutethimide........................ 2 2
Hydrocodone (for sale).............. 41,252,000 41,252,000
Hydrocodone (for conversion)........ 1,500,000 1,500,000
[[Page 38176]]
Hydromorphone....................... 3,300,000 3,300,000
Isomethadone........................ 2 2
Levo-alphacetylmethadol (LAAM)...... 6 6
Levomethorphan...................... 5 5
Levorphanol......................... 5,000 5,000
Meperidine.......................... 9,753,000 9,753,000
Metazocine.......................... 1 1
Methadone (for sale)................ 21,000,000 25,000,000
Methadone Intermediate.............. 26,000,000 26,000,000
Methamphetamine..................... 3,130,000 3,130,000
[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 35,000,000
Morphine (for sale)................. 35,000,000 35,000,000
Morphine (for conversion)........... 110,774,000 110,774,000
Nabilone............................ 2 2
Noroxymorphone (for sale)........... 1,002 1,002
Noroxymorphone (for conversion)..... 5,600,000 5,600,000
Opium............................... 1,280,000 1,280,000
Oxycodone (for sale)................ 49,200,000 49,200,000
Oxycodone (for conversion).......... 920,000 920,000
Oxymorphone......................... 534,000 534,000
Pentobarbital....................... 20,335,000 28,000,000
Phencyclidine....................... 2,021 2,021
Phenmetrazine....................... 2 2
Racemethorphan...................... 2 2
Remifentanil........................ 2,700 2,700
Secobarbital........................ 2 2
Sufentanil.......................... 6,500 6,500
Thebaine............................ 72,453,000 72,453,000
------------------------------------------------------------------------
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.
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).
The Office of Management and Budget has determined that notices of
aggregate production quotas are not subject to centralized review under
Executive Order 12866.
This action does not preempt or modify any provision of state law;
nor does it impose enforcement responsibilities on any state; nor does
it diminish the power of any state to enforce its own laws.
Accordingly, this action does not have federalism implications
warranting the application of Executive Order 13132.
The Deputy Administrator hereby certifies that this action will not
have a significant impact upon small entities whose interests must be
considered under the Regulatory Flexibility Act, 5 U.S.C. 601 et seq.
The establishment of aggregate production quotas for Schedules I and II
controlled substances is mandated by law and by international treaty
obligations. The quotas are necessary to provide for the estimated
medical, scientific, research and industrial needs of the United
States, for export requirements and the establishment and maintenance
of reserve stocks. While aggregate production quotas are of primary
importance to large manufacturers, their impact upon small entities is
neither negative nor beneficial. Accordingly, the Deputy Administrator
has determined that this action does not require a regulatory
flexibility analysis.
This action meets the applicable standards set forth in Sections
3(a) and 3(b)(2) of Executive Order 12988 Civil Justice Reform.
This action will not result in the expenditure by state, local, and
tribal governments, in the aggregate, or by the private sector, of
$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 ability of United States-based companies to
compete with foreign-based companies in domestic and export markets.
Dated: June 26, 2006.
Michele M. Leonhart,
Deputy Administrator.
[FR Doc. E6-10467 Filed 7-3-06; 8:45 am]
BILLING CODE 4410-09-P