Controlled Substances: Proposed Revised Aggregate Production Quotas for 2007, 24608-24611 [E7-8422]
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24608
Federal Register / Vol. 72, No. 85 / Thursday, May 3, 2007 / Notices
approved [by the FDA] for medical use
and placed in a Schedule other than
Schedule I, DEA cannot grant an
application to manufacture * * * these
substances to anyone who seeks to
manufacture [them] for the purpose of
distributing * * * or dispensing [them]
to[ ] ‘patients.’ ’’ Id.
The Government also argued that
marijuana and tetrahydrocannabinols
are Schedule I controlled substances
under Washington law and that the
State’s Medical Use of Marijuana Act
creates only ‘‘a narrow exception to the
classification of marijuana as a Schedule
I controlled substance.’’ Id. at 5–6.
According to the Government, the
exception allows only a ‘‘qualifying
patient’’ to possess marijuana, and such
person may only ‘‘ ‘possess no more
marijuana than is necessary for the
patient’s personal, medical use, not
exceeding the amount necessary for a
sixty-day supply.’ ’’ Id. at 6 (quoting
RCW section 69.51A.040(2)(b)). The
Government thus contends that
Respondent’s proposed activities go
‘‘well beyond what is permitted to be
manufactured under applicable
Washington * * * law,’’ and thus
Respondent would be non-compliant
with state law. Id. (citing 21 U.S.C.
823(a)(2)) (requiring Attorney General to
consider ‘‘compliance with applicable
State law’’ in considering application to
manufacture Schedule I controlled
substances).
In its submission, Respondent’s
owners stated that ‘‘there are no
witnesses,’’ that ‘‘[a]ll documents have
been submitted,’’ and that ‘‘[o]ther
testimony ha[d] been submitted in the’’
questionnaire they had previously sent
to DEA. Resp. Letter 1 (July 11, 2006).
Respondent’s owners further stated that
it was their ‘‘intention to manufacture,
package and sell [marijuana] to the
various authorized outlets (state
pharmacies within the state of
Washington).’’ Id. With respect to the
legal issue presented, Respondent stated
that it is ‘‘[t]he position and law of the
State of Washington * * * that certain
qualified persons in this State have the
right as given by the voice of the people
to possess and use marijuana for
specific medical needs as described in
Washington State law.’’ Id. Respondent
further maintained that ‘‘DEA should
allow the State of Washington and
[itself] to engage [in] the legal and
correct distribution of marijuana.’’ Id.
Concluding that there were no
material facts in dispute, the ALJ
granted the Government’s motion. As
the ALJ explained, marijuana and
tetrahydrocannabinols ‘‘have a high
potential for abuse, have no currently
accepted medical use in treatment, and
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lack safety for use in treatment under
medical supervision.’’ ALJ Dec. at 3.
Because ‘‘these substances cannot be
manufactured for distribution to
patients for medical use,’’ the ALJ
concluded that DEA ‘‘cannot register an
applicant with the intention to
manufacture and distribute contrary to
federal law.’’ Id. Finally, the ALJ also
held that the Washington state law
exception does not ‘‘extend to the
manufacturing of these substances and
therefore Respondent lacks state
authority’’ to conduct its proposed
activity. The ALJ thus recommended
that I deny Respondent’s application
and forwarded the record to me for final
agency action. Neither party filed
exceptions.
Having considered the record as a
whole, I adopt the ALJ’s opinion in its
entirety and deny Respondent’s
application. Section 303(a) of the
Controlled Substances Act provides that
the ‘‘Attorney General shall register an
applicant to manufacture controlled
substances in schedule I or II if he
determines that such registration is
consistent with the public interest.’’ 21
U.S.C. 823(a). While Congress provided
six factors to be considered in
determining the public interest, id., it is
well settled that I may rely on any one
or a combination of factors, and may
give each factor the weight I deem
appropriate in determining whether an
application for registration should be
denied. See ALRA Laboratories, Inc., 59
FR 50620, 50621 (1994). Moreover, I am
‘‘not required to make findings as to all
of the factors.’’ Hoxie v. DEA, 419 F.3d
477, 482 (6th Cir. 2005); Morall v. DEA,
412 F.3d 165, 173–74 (D.C. Cir. 2005).
Here, it is clear that Respondent’s
proposed activity would not comply
with applicable Federal and State laws
and would be inconsistent with public
health and safety. See 21 U.S.C.
823(a)(2) & (6). Congress placed
marijuana (and tetrahydrocannabinols)
on Schedule I based on its
determination that both substances have
‘‘ ‘no currently accepted medical use’ at
all.’’ Oakland Cannabis Buyers, 532 U.S.
at 483, 491 (2001). Until Congress
revises that determination, it is a federal
criminal offense to manufacture either
of these substances for any purpose
other than to supply an FDA preapproved research project. See Gonzales
v. Raich, 545 U.S. 1, 14 (2005).
Moreover, it also appears that
Respondent’s proposed activities would
violate Washington law. See State v.
Tracy, 147 P.3d 559, 561–62 (Wash.
2006) (upholding conviction for
possession and manufacturing of
marijuana because ‘‘only qualifying
patients are entitled to the defense
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under the act’’). Accordingly,
Respondent’s registration would be
inconsistent with the public interest.
See 21 U.S.C. 823(a).
Order
Pursuant to the authority vested in me
by 21 U.S.C. 823(a), as well as by 28
CFR 0.100(b) & 0.104, I hereby order
that the application of Green Acres
Farm, Inc., for a DEA Certificate of
Registration to manufacture marijuana
and tetrahydrocannabinols be, and it
hereby is, denied. This order is effective
June 4, 2007.
Dated: April 25, 2007.
Michele M. Leonhart,
Deputy Administrator.
[FR Doc. E7–8454 Filed 5–2–07; 8:45 am]
BILLING CODE 4410–09–P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA–290R]
Controlled Substances: Proposed
Revised Aggregate Production Quotas
for 2007
Drug Enforcement
Administration (DEA), Justice.
ACTION: Notice of proposed revised 2007
aggregate production quotas.
AGENCY:
SUMMARY: This notice proposes revised
2007 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 May 24, 2007.
ADDRESSES: To ensure proper handling
of comments, please reference ‘‘Docket
No. DEA–290R 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/ODL. Written comments
sent via express mail should be sent to
DEA Headquarters, Attention: DEA
Federal Register Representative/ODL,
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
E:\FEDREG\03MYN1.LOC
03MYN1
Federal Register / Vol. 72, No. 85 / Thursday, May 3, 2007 / Notices
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, PhD, 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 11, 2006, a notice of
established initial 2007 aggregate
production quotas for certain controlled
substances in schedules I and II was
published in the Federal Register (71
FR 71559). This notice stipulated that
the DEA would adjust the quotas in
early 2007 as provided for in 21 CFR
Part 1303.
The proposed revised 2007 aggregate
production quotas represent those
quantities of controlled substances in
schedules I and II 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.
mmaher on DSK3CLS3C1PROD with $$_JOB
These quotas do not include imports of
controlled substances for use in
industrial processes.
The proposed revisions are based on
a review of 2006 year-end inventories,
2006 disposition data submitted by
quota applicants, estimates of the
medical needs of the United States,
product development, and other
information available to the DEA.
Therefore, under the authority vested
in the Attorney General by Section 306
of the CSA (21 U.S.C. 826), and
delegated to the Administrator of the
DEA by 28 CFR 0.100, and redelegated
to the Deputy Administrator pursuant to
28 CFR 0.104, the Deputy Administrator
hereby proposes the following revised
2007 aggregate production quotas for the
following controlled substances,
expressed in grams of anhydrous acid or
base:
Previously established
initial 2007 quotas
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 ...........................................................................................................................................
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24609
E:\FEDREG\03MYN1.LOC
2,001,000 g
2
10
2
2
20
10
22
2
2
7
77
2
12
2
5
2
2
2
2
2
2
2
3
2
2
5
8
2
2
2
2
2
2
2
8
3
302
2
50
2,549,000
3
13,100,000
5
3,000
2
1
03MYN1
Proposed revised
2007 quotas
2,001,000 g
2
10
2
2
20
10
22
2
2
2
77
2
12
2
5
2
2
2
2
2
2
2
3
2
2
5
8
2
2
2
2
2
2
2
8
3
302
2
50
2,549,000
3
13,100,000
5
3,000
2
1
24610
Federal Register / Vol. 72, No. 85 / Thursday, May 3, 2007 / Notices
Previously established
initial 2007 quotas
Basic class—Schedule I
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 ...................................................................................................................................
61
4,500,000
2
10
4
2
310
7
2
2
2
52
2
16
2
2
2
7
7
312,500
2
2
Previously established
initial 2007 quotas
Basic class—Schedule II
1–Phenylcyclohexylamine ................................................................................................................
Alfentanil ..........................................................................................................................................
Alphaprodine ....................................................................................................................................
Amobarbital ......................................................................................................................................
Amphetamine (for sale) ...................................................................................................................
Amphetamine (for conversion) ........................................................................................................
Cocaine ............................................................................................................................................
Codeine (for sale) ............................................................................................................................
Codeine (for conversion) .................................................................................................................
Dextropropoxyphene ........................................................................................................................
Dihydrocodeine ................................................................................................................................
Diphenoxylate ..................................................................................................................................
Ecgonine ..........................................................................................................................................
Ethylmorphine ..................................................................................................................................
Fentanyl ...........................................................................................................................................
Glutethimide .....................................................................................................................................
Hydrocodone (for sale) ....................................................................................................................
Hydrocodone (for conversion) .........................................................................................................
Hydromorphone ...............................................................................................................................
Isomethadone ..................................................................................................................................
Levo-alphacetylmethadol (LAAM) ....................................................................................................
Levomethorphan ..............................................................................................................................
Levorphanol .....................................................................................................................................
Lisdexamfetamine ............................................................................................................................
Meperidine .......................................................................................................................................
Metazocine .......................................................................................................................................
Methadone (for sale) .......................................................................................................................
Methadone Intermediate ..................................................................................................................
Methamphetamine ...........................................................................................................................
2g
7,200
2
3
17,000,000
0
286,000
39,605,000
59,000,000
120,000,000
2,435,000
828,000
83,000
2
1,428,000
2
42,000,000
1,500,000
3,300,000
2
6
5
6,000
0
9,753,000
1
25,000,000
26,000,000
3,130,000
Proposed revised
2007 quotas
61
4,500,000
2
10
4
2
310
7
2
2
2
52
2
16
2
2
2
7
7
312,500
2
2
Proposed revised
2007 quotas
2g
7,200
2
3
17,000,000
2,760,000
286,000
39,605,000
59,000,000
120,000,000
2,435,000
828,000
83,000
2
1,428,000
2
42,000,000
1,500,000
3,300,000
2
6
5
6,000
6,200,000
9,753,000
1
25,000,000
26,000,000
3,130,000
mmaher on DSK3CLS3C1PROD with $$_JOB
[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 ..................................................................................................................................
Oxymorphone (for conversion) ........................................................................................................
Pentobarbital ....................................................................................................................................
Phencyclidine ...................................................................................................................................
Phenmetrazine .................................................................................................................................
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35,000,000 g
35,000,000
110,774,000
3,002
1,002
11,000,000
1,400,000
56,000,000
25,000,000
1,800,000
15,300,000
28,000,000
2,021
2
03MYN1
35,000,000 g
35,000,000
110,774,000
3,002
1,002
11,000,000
1,400,000
56,000,000
25,000,000
1,800,000
15,300,000
28,000,000
2,021
2
Federal Register / Vol. 72, No. 85 / Thursday, May 3, 2007 / Notices
Previously established
initial 2007 quotas
Basic class—Schedule II
mmaher on DSK3CLS3C1PROD with $$_JOB
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.
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
VerDate Mar 15 2010
05:02 Aug 19, 2011
Jkt 223001
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 $120,000,000 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: April 25, 2007.
Michele M. Leonhart,
Deputy Administrator.
[FR Doc. E7–8422 Filed 5–2–07; 8:45 am]
BILLING CODE 4410–09–P
DEPARTMENT OF JUSTICE
Federal Bureau of Investigation
Meeting of the Compact Council for the
National Crime Prevention and Privacy
Compact
Federal Bureau of
Investigation.
ACTION: Meeting notice.
AGENCY:
SUMMARY: The purpose of this notice is
to announce a meeting of the National
Crime Prevention and Privacy Compact
Council (Council) created by the
National Crime Prevention and Privacy
Compact Act of 1998 (Compact). Thus
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2
5,000
2
12,300
102,000,000
24611
Proposed revised
2007 quotas
2
5,000
2
12,300
102,000,000
far, the Federal Government and 27
states are parties to the Compact which
governs the exchange of criminal history
records for licensing, employment, and
similar purposes. The Compact also
provides a legal framework for the
establishment of a cooperative federalstate system to exchange such records.
The United States Attorney General
appointed 15 persons from federal and
state agencies to serve on the Council.
The Council will prescribe system rules
and procedures for the effective and
proper operation of the Interstate
Identification Index System.
Matters for discussion are expected to
include:
(1) Establishment of State
Noncriminal Justice Audit Programs
(2) New National Child Protection
Act/Volunteers for Children Act
Guidelines
(3) New Compact Council Strategic
Plan
The meeting will be open to the
public on a first-come, first-seated basis.
Any member of the public wishing to
file a written statement with the Council
or wishing to address this session of the
Council should notify Mr. Todd C.
Commodore at (304) 625–2803, at least
24 hours prior to the start of the session.
The notification should contain the
requestor’s name and corporate
designation, consumer affiliation, or
government designation, along with a
short statement describing the topic to
be addressed and the time needed for
the presentation. Requesters will
ordinarily be allowed up to 15 minutes
to present a topic.
The Council will meet
in open session from 9 a.m. until 5 p.m.,
on May 23–24, 2007.
DATES AND TIMES:
The meeting will take place
at the Hyatt Regency Louisville, 320
West Jefferson Street, Louisville,
Kentucky, telephone (502) 581–1234.
ADDRESSES:
FOR FURTHER INFORMATION CONTACT:
Inquiries may be addressed to Mr. Todd
C. Commodore, FBI Compact Officer,
Compact Council Office, Module B3,
1000 Custer Hollow Road, Clarksburg,
West Virginia 26306–0148, telephone
(304) 625–2803, facsimile (304) 625–
2539.
E:\FEDREG\03MYN1.LOC
03MYN1
]]>Agencies
[Federal Register Volume 72, Number 85 (Thursday, May 3, 2007)]
[Notices]
[Pages 24608-24611]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E7-8422]
-----------------------------------------------------------------------
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA-290R]
Controlled Substances: Proposed Revised Aggregate Production
Quotas for 2007
AGENCY: Drug Enforcement Administration (DEA), Justice.
ACTION: Notice of proposed revised 2007 aggregate production quotas.
-----------------------------------------------------------------------
SUMMARY: This notice proposes revised 2007 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 May 24, 2007.
ADDRESSES: To ensure proper handling of comments, please reference
``Docket No. DEA-290R 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/ODL. Written comments sent via express
mail should be sent to DEA Headquarters, Attention: DEA Federal
Register Representative/ODL, 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
[[Page 24609]]
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, PhD, 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 11, 2006, a notice of established initial 2007
aggregate production quotas for certain controlled substances in
schedules I and II was published in the Federal Register (71 FR 71559).
This notice stipulated that the DEA would adjust the quotas in early
2007 as provided for in 21 CFR Part 1303.
The proposed revised 2007 aggregate production quotas represent
those quantities of controlled substances in schedules I and II 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.
These quotas do not include imports of controlled substances for use in
industrial processes.
The proposed revisions are based on a review of 2006 year-end
inventories, 2006 disposition data submitted by quota applicants,
estimates of the medical needs of the United States, product
development, and other information available to the DEA.
Therefore, under the authority vested in the Attorney General by
Section 306 of the CSA (21 U.S.C. 826), and delegated to the
Administrator of the DEA by 28 CFR 0.100, and redelegated to the Deputy
Administrator pursuant to 28 CFR 0.104, the Deputy Administrator hereby
proposes the following revised 2007 aggregate production quotas for the
following controlled substances, expressed in grams of anhydrous acid
or base:
------------------------------------------------------------------------
Previously
Basic class--Schedule I established initial Proposed revised
2007 quotas 2007 quotas
------------------------------------------------------------------------
2,5-Dimethoxyamphetamine.... 2,001,000 g 2,001,000 g
2,5-Dimethoxy-4- 2 2
ethylamphetamine (DOET)....
2,5-Dimethoxy-4-(n)- 10 10
propylthiophenethylamine
(2C-T-7)...................
3-Methylfentanyl............ 2 2
3-Methylthiofentanyl........ 2 2
3,4-Methylenedioxyamphetamin 20 20
e (MDA)....................
3,4-Methylenedioxy-N- 10 10
ethylamphetamine (MDEA)....
3,4-Methylenedioxymethamphet 22 22
amine (MDMA)...............
3,4,5-Trimethoxyamphetamine. 2 2
4-Bromo-2,5- 2 2
dimethoxyamphetamine (DOB).
4-Bromo-2,5- 7 2
dimethoxyphenethylamine (2-
CB)........................
4-Methoxyamphetamine........ 77 77
4-Methylaminorex............ 2 2
4-Methyl-2,5- 12 12
dimethoxyamphetamine (DOM).
5-Methoxy-3,4- 2 2
methylenedioxyamphetamine..
5-Methoxy-N,N- 5 5
diisopropyltryptamine......
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
Alpha-methyltryptamine...... 5 5
Aminorex.................... 8 8
Benzylmorphine.............. 2 2
Betacetylmethadol........... 2 2
Beta-hydroxy-3- 2 2
methylfentanyl.............
Beta-hydroxyfentanyl........ 2 2
Betameprodine............... 2 2
Betamethadol................ 2 2
Betaprodine................. 2 2
Bufotenine.................. 8 8
Cathinone................... 3 3
Codeine-N-oxide............. 302 302
Diethyltryptamine........... 2 2
Difenoxin................... 50 50
Dihydromorphine............. 2,549,000 2,549,000
Dimethyltryptamine.......... 3 3
Gamma-hydroxybutyric acid... 13,100,000 13,100,000
Heroin...................... 5 5
Hydromorphinol.............. 3,000 3,000
Hydroxypethidine............ 2 2
Ibogaine.................... 1 1
[[Page 24610]]
Lysergic acid diethylamide 61 61
(LSD)......................
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..... 7 7
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
------------------------------------------------------------------------
------------------------------------------------------------------------
Previously
Basic class--Schedule II established initial Proposed revised
2007 quotas 2007 quotas
------------------------------------------------------------------------
1-Phenylcyclohexylamine..... 2 g 2 g
Alfentanil.................. 7,200 7,200
Alphaprodine................ 2 2
Amobarbital................. 3 3
Amphetamine (for sale)...... 17,000,000 17,000,000
Amphetamine (for conversion) 0 2,760,000
Cocaine..................... 286,000 286,000
Codeine (for sale).......... 39,605,000 39,605,000
Codeine (for conversion).... 59,000,000 59,000,000
Dextropropoxyphene.......... 120,000,000 120,000,000
Dihydrocodeine.............. 2,435,000 2,435,000
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)...... 42,000,000 42,000,000
Hydrocodone (for conversion) 1,500,000 1,500,000
Hydromorphone............... 3,300,000 3,300,000
Isomethadone................ 2 2
Levo-alphacetylmethadol 6 6
(LAAM).....................
Levomethorphan.............. 5 5
Levorphanol................. 6,000 6,000
Lisdexamfetamine............ 0 6,200,000
Meperidine.................. 9,753,000 9,753,000
Metazocine.................. 1 1
Methadone (for sale)........ 25,000,000 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 g 35,000,000 g
Morphine (for sale)......... 35,000,000 35,000,000
Morphine (for conversion)... 110,774,000 110,774,000
Nabilone.................... 3,002 3,002
Noroxymorphone (for sale)... 1,002 1,002
Noroxymorphone (for 11,000,000 11,000,000
conversion)................
Opium....................... 1,400,000 1,400,000
Oxycodone (for sale)........ 56,000,000 56,000,000
Oxycodone (for conversion).. 25,000,000 25,000,000
Oxymorphone................. 1,800,000 1,800,000
Oxymorphone (for conversion) 15,300,000 15,300,000
Pentobarbital............... 28,000,000 28,000,000
Phencyclidine............... 2,021 2,021
Phenmetrazine............... 2 2
[[Page 24611]]
Racemethorphan.............. 2 2
Remifentanil................ 5,000 5,000
Secobarbital................ 2 2
Sufentanil.................. 12,300 12,300
Thebaine.................... 102,000,000 102,000,000
------------------------------------------------------------------------
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
$120,000,000 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: April 25, 2007.
Michele M. Leonhart,
Deputy Administrator.
[FR Doc. E7-8422 Filed 5-2-07; 8:45 am]
BILLING CODE 4410-09-P
