Controlled Substances: Established Initial Aggregate Production Quotas for 2007, 71559-71562 [E6-20920]
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mstockstill on PROD1PC61 with NOTICES
Federal Register / Vol. 71, No. 237 / Monday, December 11, 2006 / Notices
products distributed by [gray market
distributor] have been uncovered at
numerous clandestine
methamphetamine settings throughout
the United States and/or discovered in
the possession of individuals apparently
involved in the illicit manufacture of
methamphetamine’’).
Moreover, during clandestine lab
seizures, DEA has frequently found high
count List I chemical products, thus
indicating that these are the preferred
products for illicit methamphetamine
manufacturers. See OTC Distribution, 68
FR at 70541, MDI Pharmaceuticals, 68
FR at 4236. While Respondent proposed
to sell traditional products, he also
sought to sell similar high count
products.
Significantly, all of Respondent’s
proposed customers participate in the
non-traditional market for ephedrine
and pseudoephedrine products. DEA
orders recognize that there is a
substantial risk of diversion of List I
chemicals into the illicit manufacture of
methamphetamine when these products
are sold by non-traditional retailers. See,
e.g., Joy’s Ideas, 70 FR at 33199 (finding
that the risk of diversion was ‘‘real,
substantial and compelling’’); Jay
Enterprises, 70 FR at 24621 (noting
‘‘heightened risk of diversion’’ should
application be granted). Under DEA
precedents, an applicant’s proposal to
sell into the non-traditional market
weighs heavily against the granting of a
registration under factor five. So too
here.
Because of the methamphetamine
epidemic’s devastating impact on
communities and families throughout
the country, DEA has repeatedly denied
an application when an applicant
proposed to sell into the non-traditional
market and analysis of one of the other
statutory factors supports the
conclusion that granting the application
would create an unacceptable risk of
diversion. Thus, in Xtreme Enterprises,
67 FR 76195, 76197 (2002), my
predecessor denied an application
observing that the respondent’s ‘‘lack of
criminal record, compliance with the
law and willingness to upgrade her
security system are far outweighed by
her lack of experience with selling List
I chemicals and the fact that she intends
to sell ephedrine almost exclusively in
the gray market.’’ More recently, I
denied an application observing that the
respondent’s ‘‘lack of a criminal record
and any intent to comply with the law
and regulations are far outweighed by
his lack of experience and the
company’s intent to sell ephedrine and
pseudoephedrine exclusively to the gray
market.’’ Jay Enterprises, 70 FR at
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15:15 Dec 08, 2006
Jkt 211001
24621. Accord Prachi Enterprises, 69 FR
69407, 69409 (2004).
Here, Respondent clearly lacks
effective controls against diversion, has
no experience in the wholesale
distribution of List I chemical products,
and yet intends to distribute these
products to non-traditional retailers, a
market in which the risk of diversion is
substantial. Given these findings, it is
indisputable that granting Respondent’s
application would be ‘‘inconsistent with
the public interest.’’ 21 U.S.C. 823(h).
Order
Pursuant to the authority vested in me
by 21 U.S.C. 823(h), and 28 CFR
0.100(b) & 0.104, I hereby order that the
application of Respondent Taby
Enterprises of Osceola, Inc., for a DEA
Certificate of Registration as a
distributor of List I chemicals be, and it
hereby is, denied. This order is effective
January 10, 2007.
Dated: December 1, 2006.
Michele M. Leonhart,
Deputy Administrator.
[FR Doc. E6–20978 Filed 12–8–06; 8:45 am]
BILLING CODE 4410–09–P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[DEA #290E]
Controlled Substances: Established
Initial Aggregate Production Quotas
for 2007
Drug Enforcement
Administration (DEA), Justice.
ACTION: Notice of aggregate production
quotas for 2007.
AGENCY:
SUMMARY: This notice establishes initial
2007 aggregate production quotas for
controlled substances in schedules I and
II of the Controlled Substances Act
(CSA).
DATES: Effective Date: December 11,
2006.
FOR FURTHER INFORMATION CONTACT:
Christine A. Sannerud, Ph.D., Chief,
Drug & Chemical Evaluation Section,
Drug Enforcement Administration,
Washington, DC 20537, Telephone:
(202) 307–7183.
SUPPLEMENTARY INFORMATION: Section
306 of the CSA Title 21 United States
Code section 826 (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
Code of Federal Regulations (CFR)
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71559
0.100. The Administrator, in turn, has
redelegated this function to the Deputy
Administrator, pursuant to 28 CFR
0.104.
The 2007 aggregate production quotas
represent those quantities of controlled
substances that may be produced in the
United States in 2007 to provide
adequate supplies of each substance for:
The estimated medical, scientific,
research, and industrial needs of the
United States; lawful export
requirements; and the establishment
and maintenance of reserve stocks (21
U.S.C. 826(a) and 21 CFR 1303.11).
These quotas do not include imports of
controlled substances for use in
industrial processes.
On August 29, 2006, a notice of the
proposed initial 2007 aggregate
production quotas for certain controlled
substances in schedules I and II was
published in the Federal Register (71
FR 51214). All interested persons were
invited to comment on or object to these
proposed aggregate production quotas
on or before September 19, 2006.
Five responses were received within
the published comment period resulting
in comments on a total of 25 schedule
I and II controlled substances. The
responses commented that the proposed
aggregate production quotas for
alfentanil, aminorex, cocaine, codeine
(for conversion), dihydrocodeine,
ecgonine, fentanyl, hydrocodone,
hydromorphone, levorphanol,
methadone, methadone intermediate,
methamphetamine, methylphenidate,
morphine (for conversion), nabilone,
noroxymorphone (for conversion),
oxycodone, oxycodone (for conversion),
oxymorphone, oxymorphone (for
conversion), remifentanil, sufentanil,
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
2006 manufacturing quotas, current
2006 sales and inventories, 2007 export
requirements, additional applications
received, and research and product
development requirements. Based on
this information, the DEA has adjusted
the initial aggregate production quotas
for alfentanil, aminorex, amobarbital,
codeine (for conversion),
dextropropoxyphene, dihydrocodeine,
gamma hydroxybutyric acid, ibogaine,
hydrocodone, metazocine, nabilone,
noroxymorphone (for conversion),
oxycodone, oxycodone (for conversion),
oxymorphone, oxymorphone (for
conversion), remifentanil, sufentanil,
E:\FR\FM\11DEN1.SGM
11DEN1
71560
Federal Register / Vol. 71, No. 237 / Monday, December 11, 2006 / Notices
and thebaine to meet the legitimate
needs of the United States.
Regarding cocaine, ecgonine, fentanyl,
hydromorphone, levorphanol,
methadone, methadone intermediate,
methamphetamine, methylphenidate,
morphine (for conversion) and
tetrahydrocannabinols, the DEA has
determined that the proposed initial
2007 aggregate production quotas are
sufficient to meet the current 2007
estimated medical, scientific, research
and industrial needs of the United
States.
Pursuant to 21 CFR Part 1303, the
Deputy Administrator of the DEA will,
in 2007, adjust aggregate production
quotas and individual manufacturing
quotas allocated for the year based upon
2006 year-end inventory and actual
2006 disposition data supplied by quota
recipients for each basic class of
schedule I or II controlled substance.
Therefore, under the authority vested
in the Attorney General by Section 306
of the CSA (21 U.S.C. 826), and
delegated to the Administrator of 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 2007 initial
aggregate production quotas for the
following controlled substances,
expressed in grams of anhydrous acid or
base, be established as follows:
Established initial
2007 quotas
mstockstill on PROD1PC61 with NOTICES
Basic Class—Schedule I
2,5-Dimethoxyamphetamine .........................................................................................................................................................
2,5-Dimethoxy-4-ethylamphetamine (DOET) ................................................................................................................................
2,5-Dimethoxy-4-(n)-propylthiophenethylamine (2C–T–7) ............................................................................................................
3-Methylfentanyl ............................................................................................................................................................................
3-Methylthiofentanyl ......................................................................................................................................................................
3,4-Methylenedioxyamphetamine (MDA) ......................................................................................................................................
3,4-Methylenedioxy-N-ethylamphetamine (MDEA) .......................................................................................................................
3,4-Methylenedioxymethamphetamine (MDMA) ...........................................................................................................................
3,4,5-Trimethoxyamphetamine ......................................................................................................................................................
4-Bromo-2,5-dimethoxyamphetamine (DOB) ................................................................................................................................
4-Bromo-2,5-dimethoxyphenethylamine (2–CB) ...........................................................................................................................
4-Methoxyamphetamine ................................................................................................................................................................
4-Methylaminorex ..........................................................................................................................................................................
4-Methyl-2,5-dimethoxyamphetamine (DOM) ...............................................................................................................................
5-Methoxy-3,4-methylenedioxyamphetamine ...............................................................................................................................
5-Methoxy-N,N-diisopropyltryptamine ...........................................................................................................................................
Acetyl-alpha-methylfentanyl ..........................................................................................................................................................
Acetyldihydrocodeine ....................................................................................................................................................................
Acetylmethadol ..............................................................................................................................................................................
Allylprodine ....................................................................................................................................................................................
Alphacetylmethadol .......................................................................................................................................................................
Alpha-ethyltryptamine ....................................................................................................................................................................
Alphameprodine ............................................................................................................................................................................
Alphamethadol ..............................................................................................................................................................................
Alpha-methylfentanyl .....................................................................................................................................................................
Alpha-methylthiofentanyl ...............................................................................................................................................................
Alpha-methyltryptamine .................................................................................................................................................................
Aminorex .......................................................................................................................................................................................
Benzylmorphine .............................................................................................................................................................................
Betacetylmethadol .........................................................................................................................................................................
Beta-hydroxy-3-methylfentanyl ......................................................................................................................................................
Beta-hydroxyfentanyl .....................................................................................................................................................................
Betameprodine ..............................................................................................................................................................................
Betamethadol ................................................................................................................................................................................
Betaprodine ...................................................................................................................................................................................
Bufotenine .....................................................................................................................................................................................
Cathinone ......................................................................................................................................................................................
Codeine-N-oxide ...........................................................................................................................................................................
Diethyltryptamine ...........................................................................................................................................................................
Difenoxin .......................................................................................................................................................................................
Dihydromorphine ...........................................................................................................................................................................
Dimethyltryptamine ........................................................................................................................................................................
Gamma-hydroxybutyric acid .........................................................................................................................................................
Heroin ............................................................................................................................................................................................
Hydromorphinol .............................................................................................................................................................................
Hydroxypethidine ...........................................................................................................................................................................
Ibogaine .........................................................................................................................................................................................
Lysergic acid diethylamide (LSD) .................................................................................................................................................
Marihuana .....................................................................................................................................................................................
Mescaline ......................................................................................................................................................................................
Methaqualone ................................................................................................................................................................................
Methcathinone ...............................................................................................................................................................................
Methyldihydromorphine .................................................................................................................................................................
Morphine-N-oxide ..........................................................................................................................................................................
N,N-Dimethylamphetamine ...........................................................................................................................................................
N-Ethylamphetamine .....................................................................................................................................................................
N-Hydroxy-3,4-methylenedioxyamphetamine ...............................................................................................................................
Noracymethadol ............................................................................................................................................................................
Norlevorphanol ..............................................................................................................................................................................
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E:\FR\FM\11DEN1.SGM
11DEN1
2,001,000 g
2g
10 g
2g
2g
20 g
10 g
22 g
2g
2g
7g
77 g
2g
12 g
2g
5g
2g
2g
2g
2g
2g
2g
2g
3g
2g
2g
5g
8g
2g
2g
2g
2g
2g
2g
2g
8g
3g
302 g
2g
50 g
2,549,000 g
3g
13,100,000 g
5g
3,000 g
2g
1g
61 g
4,500,000 g
2g
10 g
4g
2g
310 g
7g
2g
2g
2g
52 g
71561
Federal Register / Vol. 71, No. 237 / Monday, December 11, 2006 / Notices
Established initial
2007 quotas
Basic Class—Schedule I
Normethadone ...............................................................................................................................................................................
Normorphine ..................................................................................................................................................................................
Para-fluorofentanyl ........................................................................................................................................................................
Phenomorphan ..............................................................................................................................................................................
Pholcodine .....................................................................................................................................................................................
Psilocybin ......................................................................................................................................................................................
Psilocyn .........................................................................................................................................................................................
Tetrahydrocannabinols ..................................................................................................................................................................
Thiofentanyl ...................................................................................................................................................................................
Trimeperidine ................................................................................................................................................................................
2g
16 g
2g
2g
2g
7g
7g
312,500 g
2g
2g
Established initial
2007 quotas
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) .......................................................................................................................................................
Hydromorphone .............................................................................................................................................................................
Isomethadone ................................................................................................................................................................................
Levo-alphacetylmethadol (LAAM) .................................................................................................................................................
Levomethorphan ...........................................................................................................................................................................
Levorphanol ...................................................................................................................................................................................
Meperidine .....................................................................................................................................................................................
Metazocine ....................................................................................................................................................................................
Methadone (for sale) .....................................................................................................................................................................
Methadone Intermediate ...............................................................................................................................................................
Methamphetamine .........................................................................................................................................................................
2g
7,200 g
2g
3g
17,000,000 g
286,000 g
39,605,000 g
59,000,000 g
120,000,000 g
2,435,000 g
828,000 g
83,000 g
2g
1,428,000 g
2g
42,000,000 g
1,500,000 g
3,300,000 g
2g
6g
5g
6,000 g
9,753,000 g
1g
25,000,000 g
26,000,000 g
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)].
mstockstill on PROD1PC61 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 aggregate production quotas
for all other schedules I and II
controlled substances included in 21
VerDate Aug<31>2005
15:15 Dec 08, 2006
Jkt 211001
CFR 1308.11 and 1308.12 be established
at zero.
The Office of Management and Budget
has determined that notices of aggregate
production quotas are not subject to
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Fmt 4703
Sfmt 4703
35,000,000 g
35,000,000 g
110,774,000 g
3,002 g
1,002 g
11,000,000 g
1,400,000 g
56,000,000 g
25,000,000 g
1,800,000 g
15,300,000 g
28,000,000 g
2,021 g
2g
2g
5,000 g
2g
12,300 g
102,000,000 g
centralized review under Executive
Order 12866.
This action does not preempt or
modify any provision of state law; nor
does it impose enforcement
E:\FR\FM\11DEN1.SGM
11DEN1
71562
Federal Register / Vol. 71, No. 237 / Monday, December 11, 2006 / Notices
mstockstill on PROD1PC61 with NOTICES
responsibilities on any state; nor does it
diminish the power of any state to
enforce its own laws. Accordingly, this
action does not have federalism
implications warranting the application
of Executive Order 13132.
The Deputy Administrator hereby
certifies that this action will have no
significant impact upon small entities
whose interests must be considered
under the Regulatory Flexibility Act, 5
U.S.C. 601 et seq. The establishment of
aggregate production quotas for
schedules I and II controlled substances
is mandated by law and by international
treaty obligations. The quotas are
necessary to provide for the estimated
medical, scientific, research and
industrial needs of the United States, for
export requirements and the
establishment and maintenance of
reserve stocks. While aggregate
production quotas are of primary
importance to large manufacturers, their
impact upon small entities is neither
negative nor beneficial. Accordingly, the
Deputy Administrator has determined
that this action does not require a
regulatory flexibility analysis.
This action meets the applicable
standards set forth in Sections 3(a) and
3(b)(2) of Executive Order 12988 Civil
Justice Reform.
This action will not result in the
expenditure by State, local, and tribal
governments, in the aggregate, or by the
private sector, of $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: December 1, 2006.
Michele M. Leonhart,
Deputy Administrator.
[FR Doc. E6–20920 Filed 12–8–06; 8:45 am]
BILLING CODE 4410–09–P
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Jkt 211001
Employee Benefits Security
Administration
DEPARTMENT OF THE TREASURY
Internal Revenue Service
PENSION BENEFIT GUARANTY
CORPORATION
RIN 1210–AB14
Proposed Revision of Annual
Information Return/Reports
AGENCIES: Employee Benefits Security
Administration, Labor, Internal Revenue
Service, Treasury, Pension Benefit
Guaranty Corporation.
ACTION: Notice of Supplemental
Proposed Forms Revisions.
SUMMARY: This document contains a
proposal to make changes required by
the Pension Protection Act of 2006
(PPA) to the Form 5500 Annual Return/
Report filed for employee benefit plans
under the Employee Retirement Income
Security Act of 1974 (ERISA) and the
Internal Revenue Code (Code). The
proposed changes supplement proposed
revisions to the Form 5500 Annual
Return/Report published, prior to the
enactment of the PPA, by the
Department of Labor, the Internal
Revenue Service, and the Pension
Benefit Guaranty Corporation (Agencies)
in the Federal Register on July 21, 2006,
at 71 FR 41616 (July 2006 Proposal).
This supplemental proposal replaces the
Schedule B, ‘‘Actuarial Information,’’
with separate actuarial schedules for
single-employer plans (Schedule SB)
and multiemployer plans (Schedule
MB) to reflect PPA changes in funding
and annual reporting requirements;
adds new questions to the Schedule R,
‘‘Retirement Plan Information,’’ to
collect additional information regarding
single and multiemployer defined
benefit pension plans required by the
PPA; and proposes having the Form
5500–SF Annual Return/Report (Short
Form 5500) included in the July 2006
Proposal serve as the simplified report
required by the PPA for plans with
fewer than 25 participants. The
revisions are being proposed for 2008
plan year filings and would affect
employee pension and welfare benefit
plans, plan sponsors, administrators,
and service providers to plans subject to
annual reporting requirements under
ERISA and the Code.
DATES: Written comments must be
received by the Department of Labor on
or before January 10, 2007.
PO 00000
Frm 00060
Fmt 4703
Sfmt 4703
Commenters are encouraged
to submit comments electronically to
https://www.regulations.gov (follow
instructions for submission) or eORI@dol.gov. Comments also may be
addressed to the Office of Regulations
and Interpretations, Employee Benefits
Security Administration, Room N–5669,
U.S. Department of Labor, 200
Constitution Avenue, NW., Washington,
DC 20210, Attn: Supplemental Form
5500 Revision (RIN 1210–AB14). If
comments are submitted electronically,
paper submissions are not necessary.
Comments will be available to the
public at https://www.dol.gov/ebsa and
https://www.regulations.gov. Comments
also will be available for public
inspection at the Public Disclosure
Room, N–1513, Employee Benefits
Security Administration, 200
Constitution Avenue, NW., Washington,
DC 20210.
FOR FURTHER INFORMATION CONTACT: Ann
Junkins, Internal Revenue Service (IRS),
(202) 283–0722, for questions relating to
Schedules SB, MB, and Schedule R, as
well as general questions relating to
reporting under the Internal Revenue
Code; Amy Viener, Pension Benefit
Guaranty Corporation (PBGC), (202)
326–4080 for questions relating to
Schedules SB and MB, and Michael
Packard, PBGC, 202 326–4080 for
questions relating to the Schedule R, as
well as questions relating to the general
reporting requirements under Title IV of
ERISA; Elizabeth A. Goodman or
Yolanda Wartenberg, Employee Benefits
Security Administration (EBSA), U.S.
Department of Labor, (202) 693–8523,
for questions relating to the Short Form
5500–SF, as well as general reporting
requirements under Title I of ERISA.
The telephone numbers referenced
above are not toll-free numbers.
To enable the public to better evaluate
the proposed changes, the Department is
making available on its Web site at
https:// www.dol.gov/ebsa, mock ups of
the Schedules SB, MB and R. Copies of
the mock ups may also be obtained by
calling the EBSA’s Public Disclosure
Room at 1.866.444.EBSA (3272).
SUPPLEMENTARY INFORMATION:
ADDRESSES:
DEPARTMENT OF LABOR
A. Background
Sections 101 and 104 of Title I and
section 4065 of Title IV of the Employee
Retirement Income Security Act of 1974
(ERISA), as amended, sections 6058(a)
and 6059(a) of the Internal Revenue
Code of 1986 (Code), as amended, and
the regulations issued under those
sections, impose certain annual
reporting and filing obligations on
pension and welfare benefit plans, as
E:\FR\FM\11DEN1.SGM
11DEN1
Agencies
[Federal Register Volume 71, Number 237 (Monday, December 11, 2006)]
[Notices]
[Pages 71559-71562]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E6-20920]
-----------------------------------------------------------------------
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[DEA 290E]
Controlled Substances: Established Initial Aggregate Production
Quotas for 2007
AGENCY: Drug Enforcement Administration (DEA), Justice.
ACTION: Notice of aggregate production quotas for 2007.
-----------------------------------------------------------------------
SUMMARY: This notice establishes initial 2007 aggregate production
quotas for controlled substances in schedules I and II of the
Controlled Substances Act (CSA).
DATES: Effective Date: December 11, 2006.
FOR FURTHER INFORMATION CONTACT: Christine A. Sannerud, Ph.D., Chief,
Drug & Chemical Evaluation Section, Drug Enforcement Administration,
Washington, DC 20537, Telephone: (202) 307-7183.
SUPPLEMENTARY INFORMATION: Section 306 of the CSA Title 21 United
States Code section 826 (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 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 2007 aggregate production quotas represent those quantities of
controlled substances that may be produced in the United States in 2007
to provide adequate supplies of each substance for: The estimated
medical, scientific, research, and industrial needs of the United
States; lawful export requirements; and the establishment and
maintenance of reserve stocks (21 U.S.C. 826(a) and 21 CFR 1303.11).
These quotas do not include imports of controlled substances for use in
industrial processes.
On August 29, 2006, a notice of the proposed initial 2007 aggregate
production quotas for certain controlled substances in schedules I and
II was published in the Federal Register (71 FR 51214). All interested
persons were invited to comment on or object to these proposed
aggregate production quotas on or before September 19, 2006.
Five responses were received within the published comment period
resulting in comments on a total of 25 schedule I and II controlled
substances. The responses commented that the proposed aggregate
production quotas for alfentanil, aminorex, cocaine, codeine (for
conversion), dihydrocodeine, ecgonine, fentanyl, hydrocodone,
hydromorphone, levorphanol, methadone, methadone intermediate,
methamphetamine, methylphenidate, morphine (for conversion), nabilone,
noroxymorphone (for conversion), oxycodone, oxycodone (for conversion),
oxymorphone, oxymorphone (for conversion), remifentanil, sufentanil,
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 2006 manufacturing quotas, current 2006 sales and inventories,
2007 export requirements, additional applications received, and
research and product development requirements. Based on this
information, the DEA has adjusted the initial aggregate production
quotas for alfentanil, aminorex, amobarbital, codeine (for conversion),
dextropropoxyphene, dihydrocodeine, gamma hydroxybutyric acid,
ibogaine, hydrocodone, metazocine, nabilone, noroxymorphone (for
conversion), oxycodone, oxycodone (for conversion), oxymorphone,
oxymorphone (for conversion), remifentanil, sufentanil,
[[Page 71560]]
and thebaine to meet the legitimate needs of the United States.
Regarding cocaine, ecgonine, fentanyl, hydromorphone, levorphanol,
methadone, methadone intermediate, methamphetamine, methylphenidate,
morphine (for conversion) and tetrahydrocannabinols, the DEA has
determined that the proposed initial 2007 aggregate production quotas
are sufficient to meet the current 2007 estimated medical, scientific,
research and industrial needs of the United States.
Pursuant to 21 CFR Part 1303, the Deputy Administrator of the DEA
will, in 2007, adjust aggregate production quotas and individual
manufacturing quotas allocated for the year based upon 2006 year-end
inventory and actual 2006 disposition data supplied by quota recipients
for each basic class of schedule I or II controlled substance.
Therefore, under the authority vested in the Attorney General by
Section 306 of the CSA (21 U.S.C. 826), and delegated to the
Administrator of 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 2007 initial aggregate production quotas for the
following controlled substances, expressed in grams of anhydrous acid
or base, be established as follows:
------------------------------------------------------------------------
Established initial 2007
Basic Class--Schedule I quotas
------------------------------------------------------------------------
2,5-Dimethoxyamphetamine.................... 2,001,000 g
2,5-Dimethoxy-4-ethylamphetamine (DOET)..... 2 g
2,5-Dimethoxy-4-(n)-propylthiophenethylamine 10 g
(2C-T-7).
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).. 7 g
4-Methoxyamphetamine........................ 77 g
4-Methylaminorex............................ 2 g
4-Methyl-2,5-dimethoxyamphetamine (DOM)..... 12 g
5-Methoxy-3,4-methylenedioxyamphetamine..... 2 g
5-Methoxy-N,N-diisopropyltryptamine......... 5 g
Acetyl-alpha-methylfentanyl................. 2 g
Acetyldihydrocodeine........................ 2 g
Acetylmethadol.............................. 2 g
Allylprodine................................ 2 g
Alphacetylmethadol.......................... 2 g
Alpha-ethyltryptamine....................... 2 g
Alphameprodine.............................. 2 g
Alphamethadol............................... 3 g
Alpha-methylfentanyl........................ 2 g
Alpha-methylthiofentanyl.................... 2 g
Alpha-methyltryptamine...................... 5 g
Aminorex.................................... 8 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.................................. 8 g
Cathinone................................... 3 g
Codeine-N-oxide............................. 302 g
Diethyltryptamine........................... 2 g
Difenoxin................................... 50 g
Dihydromorphine............................. 2,549,000 g
Dimethyltryptamine.......................... 3 g
Gamma-hydroxybutyric acid................... 13,100,000 g
Heroin...................................... 5 g
Hydromorphinol.............................. 3,000 g
Hydroxypethidine............................ 2 g
Ibogaine.................................... 1 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
[[Page 71561]]
Normethadone................................ 2 g
Normorphine................................. 16 g
Para-fluorofentanyl......................... 2 g
Phenomorphan................................ 2 g
Pholcodine.................................. 2 g
Psilocybin.................................. 7 g
Psilocyn.................................... 7 g
Tetrahydrocannabinols....................... 312,500 g
Thiofentanyl................................ 2 g
Trimeperidine............................... 2 g
------------------------------------------------------------------------
------------------------------------------------------------------------
Established initial 2007
Basic Class--Schedule II quotas
------------------------------------------------------------------------
1-Phenylcyclohexylamine..................... 2 g
Alfentanil.................................. 7,200 g
Alphaprodine................................ 2 g
Amobarbital................................. 3 g
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.............................. 2,435,000 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............................... 3,300,000 g
Isomethadone................................ 2 g
Levo-alphacetylmethadol (LAAM).............. 6 g
Levomethorphan.............................. 5 g
Levorphanol................................. 6,000 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)................... 110,774,000 g
Nabilone.................................... 3,002 g
Noroxymorphone (for sale)................... 1,002 g
Noroxymorphone (for conversion)............. 11,000,000 g
Opium....................................... 1,400,000 g
Oxycodone (for sale)........................ 56,000,000 g
Oxycodone (for conversion).................. 25,000,000 g
Oxymorphone................................. 1,800,000 g
Oxymorphone (for conversion)................ 15,300,000 g
Pentobarbital............................... 28,000,000 g
Phencyclidine............................... 2,021 g
Phenmetrazine............................... 2 g
Racemethorphan.............................. 2 g
Remifentanil................................ 5,000 g
Secobarbital................................ 2 g
Sufentanil.................................. 12,300 g
Thebaine.................................... 102,000,000 g
------------------------------------------------------------------------
The Deputy Administrator further orders that aggregate production
quotas for all other schedules I and II controlled substances included
in 21 CFR 1308.11 and 1308.12 be established at zero.
The Office of Management and Budget has determined that notices of
aggregate production quotas are not subject to centralized review under
Executive Order 12866.
This action does not preempt or modify any provision of state law;
nor does it impose enforcement
[[Page 71562]]
responsibilities on any state; nor does it diminish the power of any
state to enforce its own laws. Accordingly, this action does not have
federalism implications warranting the application of Executive Order
13132.
The Deputy Administrator hereby certifies that this action will
have no significant impact upon small entities whose interests must be
considered under the Regulatory Flexibility Act, 5 U.S.C. 601 et seq.
The establishment of aggregate production quotas for schedules I and II
controlled substances is mandated by law and by international treaty
obligations. The quotas are necessary to provide for the estimated
medical, scientific, research and industrial needs of the United
States, for export requirements and the establishment and maintenance
of reserve stocks. While aggregate production quotas are of primary
importance to large manufacturers, their impact upon small entities is
neither negative nor beneficial. Accordingly, the Deputy Administrator
has determined that this action does not require a regulatory
flexibility analysis.
This action meets the applicable standards set forth in Sections
3(a) and 3(b)(2) of Executive Order 12988 Civil Justice Reform.
This action will not result in the expenditure by State, local, and
tribal governments, in the aggregate, or by the private sector, of
$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: December 1, 2006.
Michele M. Leonhart,
Deputy Administrator.
[FR Doc. E6-20920 Filed 12-8-06; 8:45 am]
BILLING CODE 4410-09-P