Proposed Aggregate Production Quotas for Schedule I and II Controlled Substances and Proposed Assessment of Annual Needs for the List I Chemicals Ephedrine, Pseudoephedrine, and Phenylpropanolamine for 2013, 46519-46523 [2012-19052]
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TKELLEY on DSK3SPTVN1PROD with NOTICES
Federal Register / Vol. 77, No. 150 / Friday, August 3, 2012 / Notices
within the vicinity of Los Banos,
California. The general project location
is south of State Route 152 between U.S.
101 and Interstate 5, approximately two
hours southeast from San Francisco.
The RMP/GP area is owned by
Reclamation and was built as part of the
water storage and delivery system of
reservoirs, aqueducts, power plants, and
pumping stations operated under the
California State Water Project and
Central Valley Project. Construction
began on San Luis Reservoir in 1963
and was completed in 1967 with
planned joint-use by the State Water
Project and the Central Valley Project.
The California Department of Parks and
Recreation was given the responsibility
to plan, design, construct, maintain, and
operate the recreation areas surrounding
the reservoirs.
The new plan will: (1) Enhance
natural resources and recreational
opportunities without interrupting
reservoir operations; (2) provide
recreational opportunities to meet the
demands of a growing population with
diverse interests; (3) ensure diversity of
recreational opportunities and quality of
the recreational experience; (4) protect
natural, cultural, and recreational
sources while providing resource
education opportunities and
stewardship; and (5) provide updated
management direction for establishing a
new management agreement with the
State of California.
The Draft EIS/Revised Draft EIR
outlines the formulation and evaluation
of alternatives designed to address these
issues through a representation of the
varied interests at the Plan Area. The No
Action/No Project Alternative
(Alternative 1) would result in the
continuation of current management
practices. Action Alternative 2 (Limited
New Access and Development)
emphasizes resource protection and
limited new development. Action
Alternative 3 (Moderate New Access
and Development) balances natural and
cultural resource protection and
recreation opportunities. Action
Alternative 4 (Maximum New Access
and Development) provides the most
overall recreation facility development.
The Draft RMP/GP EIS/EIR has been
developed within the authorities
provided by Congress through the
Reclamation Recreation Management
Act of 1992 (Pub. L. 102–575, Title 28,
16 U.S.C. 460L) and other applicable
agency and Department of the Interior
policies.
Copies of the Draft RMP/GP EIS/EIR
are available for public review at the
following locations:
VerDate Mar<15>2010
17:33 Aug 02, 2012
Jkt 226001
• Bureau of Reclamation, Mid-Pacific
Region, Regional Library, 2800 Cottage
Way, Sacramento, CA 95825.
• Bureau of Reclamation, SouthCentral California Area Office, 1243 N
Street, Fresno, CA 93721.
• Four Rivers Sector Office, 31426
Gonzaga Road, Gustine, CA 95322
• Los Banos Library, 1312 South 7th
Street, Los Banos, CA 93635.
• California Department of Parks and
Recreation, Northern Service Center,
One Capitol Mall, Suite 500,
Sacramento, CA 95814.
• Bureau of Reclamation, Denver
Office Library, Building 67, Room 167,
Denver Federal Center, 6th and Kipling,
Denver, CO 80225.
• Natural Resources Library, U.S.
Department of the Interior, 1849 C Street
NW., Main Interior Building,
Washington, DC 20240–0001.
Public Meeting
A brief presentation, including a
project overview, will open the public
meeting. This will be followed by an
open house during which individual
concerns and questions will be
addressed through interaction with the
project team.
If special assistance is required at the
public meeting, please contact Mr. Dave
Woolley at 559–487–5049, (TTY 1–800–
735–2929), or by emailing
dwoolley@usbr.gov. Please notify Mr.
Woolley as far in advance as possible to
enable Reclamation staff enough time to
secure the needed services. If a request
cannot be honored, the requestor will be
notified.
Public Disclosure
Before including your address, phone
number, email address, or other
personal identifying information in your
comment, you should be aware that
your entire comment—including your
personal identifying information—may
be made publicly available at any time.
While you can ask us in your comment
to withhold your personal identifying
information from public review, we
cannot guarantee that we will be able to
do so.
Dated: May 17, 2012.
Pablo R. Arroyave,
Deputy Regional Director, Mid-Pacific Region.
[FR Doc. 2012–19021 Filed 8–2–12; 8:45 am]
BILLING CODE 4310–MN–P
PO 00000
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA–365]
Proposed Aggregate Production
Quotas for Schedule I and II Controlled
Substances and Proposed
Assessment of Annual Needs for the
List I Chemicals Ephedrine,
Pseudoephedrine, and
Phenylpropanolamine for 2013
Drug Enforcement
Administration (DEA), Department of
Justice.
AGENCY:
Notice with request for
comments.
ACTION:
This notice proposes initial
year 2013 aggregate production quotas
for controlled substances in schedules I
and II of the Controlled Substances Act
(CSA) and assessment of annual needs
for the list I chemicals ephedrine,
pseudoephedrine, and
phenylpropanolamine.
SUMMARY:
Electronic comments must be
submitted and written comments must
be postmarked on or before September
4, 2012. Commenters should be aware
that the electronic Federal Docket
Management System will not accept
comments after midnight Eastern Time
on the last day of the comment period.
DATES:
To ensure proper handling
of comments, please reference ‘‘Docket
No. DEA–365’’ on all electronic and
written correspondence. DEA
encourages that all comments be
submitted electronically through https://
www.regulations.gov using the
electronic comment form provided on
that site. An electronic copy of this
document is also available at the https://
www.regulations.gov Web site for easy
reference. Paper comments that
duplicate the electronic submission are
not necessary as all comments
submitted to https://www.regulations.gov
will be posted for public review and are
part of the official docket record.
Written comments submitted via regular
or express mail should be sent to the
Drug Enforcement Administration,
Attention: DEA Federal Register
Representative/ODL, 8701 Morrissette
Drive, Springfield, VA 22152.
ADDRESSES:
John
W. Partridge, Chief, Liaison and Policy
Section, Drug Enforcement
Administration, 8701 Morrissette Drive,
Springfield, VA 22152, Telephone: (202)
307–4654.
FOR FURTHER INFORMATION CONTACT:
SUPPLEMENTARY INFORMATION:
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Federal Register / Vol. 77, No. 150 / Friday, August 3, 2012 / Notices
Posting of Public Comments
Please note that all comments
received are considered part of the
public record and made available for
public inspection online at https://
www.regulations.gov and in the DEA’s
public docket. Such information
includes personal identifying
information (such as your name,
address, etc.) voluntarily submitted by
the commenter.
If you want to submit personal
identifying information (such as your
name, address, etc.) as part of your
comment, but do not want it to be
posted online or made available in the
public docket, you must include the
phrase ‘‘PERSONAL IDENTIFYING
INFORMATION’’ in the first paragraph
of your comment. You must also place
all the personal identifying information
you do not want posted online or made
available in the public docket in the first
paragraph of your comment and identify
what information you want redacted.
If you want to submit confidential
business information as part of your
comment, but do not want it to be
posted online or made available in the
public docket, you must include the
phrase ‘‘CONFIDENTIAL BUSINESS
INFORMATION’’ in the first paragraph
of your comment. You must also
prominently identify confidential
business information to be redacted
within the comment. If a comment has
so much confidential business
information that it cannot be effectively
redacted, all or part of that comment
may not be posted online or made
available in the public docket.
Personal identifying information and
confidential business information
identified and located as set forth above
will be redacted, and the comment, in
redacted form, will be posted online and
placed in the DEA’s public docket file.
Please note that the Freedom of
Information Act applies to all comments
received. If you wish to inspect the
agency’s public docket file in person by
appointment, please see the FOR
FURTHER INFORMATION CONTACT
TKELLEY on DSK3SPTVN1PROD with NOTICES
paragraph.
Background
Section 306 of the CSA (21 U.S.C.
826) requires the Attorney General to
establish aggregate production quotas
for each basic class of controlled
substance listed in schedules I and II
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Jkt 226001
and for ephedrine, pseudoephedrine,
and phenylpropanolamine. 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.
The proposed year 2013 aggregate
production quotas represent those
quantities of schedule I and II controlled
substances, and the list I chemicals
ephedrine, pseudoephedrine, and
phenylpropanolamine, to be
manufactured in the United States in
2013 to provide 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 include
imports of ephedrine, pseudoephedrine,
and phenylpropanolamine but do not
include imports of controlled
substances for use in industrial
processes.
In determining the proposed 2013
aggregate production quotas and
assessment of annual needs, DEA has
taken into account the criteria that DEA
is required to consider in accordance
with 21 U.S.C. 826(a), 21 CFR 1303.11
(aggregate production quotas for
controlled substances), and 21 CFR
1315.11 (assessment of annual needs for
ephedrine, pseudoephedrine, and
phenylpropanolamine). DEA proposes
the aggregate production quotas and
assessment of annual needs for 2013 by
considering (1) total net disposal of the
class or chemical by all manufacturers
and chemical importers during the
current and two preceding years; (2)
trends in the national rate of net
disposal of the class or chemical; (3)
total actual (or estimated) inventories of
the class or chemical and of all
substances manufactured from the class
or chemical, and trends in inventory
accumulation; (4) projected demand for
such class or chemical as indicated by
procurement and chemical import
quotas requested pursuant to 21 CFR
1303.12, 1315.32, and 1315.34; and (5)
other factors affecting the medical,
scientific, research, and industrial needs
in the United States, lawful export
requirements, and reserve stocks, as the
Deputy Administrator finds relevant.
Other factors DEA considered in
calculating the aggregate production
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quotas, but not the assessment of annual
needs, include product development
requirements of both bulk and finished
dosage form manufacturers, and other
pertinent information. In determining
the proposed 2013 assessment of annual
needs, DEA used the calculation
methodology previously described in
the 2010 and 2011 assessment of annual
needs (74 FR 60294 and 75 FR 79407,
respectively).
DEA also specifically considered that
inventory allowances granted to
individual manufacturers may not
always result in the availability of
sufficient quantities to maintain an
adequate reserve stock pursuant to 21
U.S.C. 826(a), as intended. See 21 CFR
1303.24. This would be concerning if a
natural disaster or other unforeseen
event resulted in substantial disruption
to the amount of controlled substances
available to provide for legitimate
public need. As such, DEA proposes to
include in all schedule II aggregate
production quotas, and certain schedule
I aggregate production quotas (gammahydroxybutyric acid and
tetrahydrocannabinols), an additional
25% of the estimated medical,
scientific, and research needs as part of
the amount necessary to ensure the
establishment and maintenance of
reserve stocks. The resulting established
aggregate production quota will reflect
these included amounts. This action
will not affect the ability of
manufacturers to maintain inventory
allowances as specified by regulation.
DEA expects that maintaining this
reserve in certain established aggregate
production quotas will mitigate adverse
public affects if an unforeseen event
resulted in substantial disruption to the
amount of controlled substances
available to provide for legitimate
public need, as determined by DEA.
DEA does not anticipate utilizing the
reserve in the absence of these
circumstances.
The Deputy Administrator, therefore,
proposes that the year 2013 aggregate
production quotas and assessment of
annual needs for the following schedule
I and II controlled substances and for
the list I chemicals ephedrine,
pseudoephedrine, and
phenylpropanolamine, expressed in
grams of anhydrous acid or base, be
established as follows:
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Federal Register / Vol. 77, No. 150 / Friday, August 3, 2012 / Notices
Proposed
2013
quotas
g
TKELLEY on DSK3SPTVN1PROD with NOTICES
Basic Class—Schedule I
1-(5-Fluoropentyl)-3-(1-naphthoyl)indole (AM2201) ..................................................................................................
1-(5-Fluoropentyl)-3-(2-iodobenzoyl)indole (AM694) .................................................................................................
1-[1-(2-Thienyl)cyclohexyl]piperidine .........................................................................................................................
1-[2-(4-Morpholinyl)ethyl]-3-(1-naphthoyl)indole (JWH–200) ....................................................................................
1-Butyl-3-(1-naphthoyl)indole (JWH–073) .................................................................................................................
1-Cyclohexylethyl-3-(2-methoxyphenylacetyl)indole (SR–18 and RCS–8) ...............................................................
1-Hexyl-3-(1-naphthoyl)indole (JWH–019) ................................................................................................................
1-Methyl-4-phenyl-4-propionoxypiperidine .................................................................................................................
1-Pentyl-3-(1-naphthoyl)indole (JWH–018 and AM678) ...........................................................................................
1-Pentyl-3-(2-chlorophenylacetyl)indole (JWH–203) .................................................................................................
1-Pentyl-3-(2-methoxyphenylacetyl)indole (JWH–250) .............................................................................................
1-Pentyl-3-(4-chloro-1-naphthoyl)indole (JWH–398) .................................................................................................
1-Pentyl-3-(4-methyl-1-naphthoyl)indole (JWH–122) ................................................................................................
1-Pentyl-3-[1-(4-methoxynaphthoyl)]indole (JWH–081) ............................................................................................
1-Pentyl-3-[(4-methoxy)-benzoyl]indole (SR–19, RCS–4) .........................................................................................
2-(2,5-Dimethoxy-4-(n)-propylphenyl)ethanamine (2C–P) ........................................................................................
2-(2,5-Dimethoxy-4-ethylphenyl)ethanamine (2C–E) ................................................................................................
2-(2,5-Dimethoxy-4-methylphenyl)ethanamine (2C–D) .............................................................................................
2-(2,5-Dimethoxy-4-nitro-phenyl)ethanamine (2C–N) ...............................................................................................
2-(2,5-Dimethoxyphenyl)ethanamine (2C–H) ............................................................................................................
2-(4-Chloro-2,5-dimethoxyphenyl)ethanamine (2C–C) ..............................................................................................
2-(4-Iodo-2,5-dimethoxyphenyl)ethanamine (2C–I) ...................................................................................................
2,5-Dimethoxy-4-ethylamphetamine (DOET) ............................................................................................................
2,5-Dimethoxy-4-n-propylthiophenethylamine ...........................................................................................................
2,5-Dimethoxyamphetamine ......................................................................................................................................
2-[4-(Ethylthio)-2,5-dimethoxyphenyl]ethanamine (2C–T–2) .....................................................................................
2-[4-(Isopropylthio)-2,5-dimethoxyphenyl]ethanamine (2C–T–4) ..............................................................................
3-Methylfentanyl .........................................................................................................................................................
3-Methylthiofentanyl ...................................................................................................................................................
3,4-Methylenedioxyamphetamine (MDA) ..................................................................................................................
3,4-Methylenedioxy-N-methylcathinone (methylone) ................................................................................................
3,4-Methylenedioxy-N-ethylamphetamine (MDEA) ...................................................................................................
3,4-Methylenedioxymethamphetamine (MDMA) .......................................................................................................
3,4-Methylenedioxypyrovalerone (MDPV) .................................................................................................................
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) ............................................................................................................
4-Methyl-N-methylcathinone (mephedrone) ..............................................................................................................
5-(1,1-Dimethylheptyl)-2-[(1R,3S)-3-hydroxycyclohexyl]-phenol ...............................................................................
5-(1,1-Dimethyloctyl)-2-[(1R,3S)-3-hydroxycyclohexyl]-phenol (cannabicyclohexanol or CP–47, 497 C8-homolog)
5-Methoxy-3,4-methylenedioxyamphetamine ............................................................................................................
5-Methoxy-N,N-diisopropyltryptamine ........................................................................................................................
5-Methoxy-N,N-dimethyltryptamine ...........................................................................................................................
Acetyl-alpha-methylfentanyl .......................................................................................................................................
Acetyldihydrocodeine .................................................................................................................................................
Acetylmethadol ..........................................................................................................................................................
Allylprodine ................................................................................................................................................................
Alphacetylmethadol ....................................................................................................................................................
Alpha-ethyltryptamine ................................................................................................................................................
Alphameprodine .........................................................................................................................................................
Alphamethadol ...........................................................................................................................................................
Alpha-methylfentanyl .................................................................................................................................................
Alpha-methylthiofentanyl ............................................................................................................................................
Alpha-methyltryptamine (AMT) ..................................................................................................................................
Aminorex ....................................................................................................................................................................
Benzylmorphine .........................................................................................................................................................
Betacetylmethadol .....................................................................................................................................................
Beta-hydroxy-3-methylfentanyl ..................................................................................................................................
Beta-hydroxyfentanyl .................................................................................................................................................
Betameprodine ...........................................................................................................................................................
Betamethadol .............................................................................................................................................................
Betaprodine ................................................................................................................................................................
Bufotenine ..................................................................................................................................................................
Cathinone ...................................................................................................................................................................
Codeine-N-oxide ........................................................................................................................................................
Desomorphine ............................................................................................................................................................
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45
45
5
45
45
45
45
2
45
45
45
45
45
45
45
15
15
15
15
15
15
15
12
12
12
15
15
2
2
30
15
24
35
15
12
12
12
88
12
12
15
68
53
12
12
10
2
2
2
2
2
12
2
2
2
2
12
12
2
2
2
2
2
2
2
3
12
602
5
46522
Federal Register / Vol. 77, No. 150 / Friday, August 3, 2012 / Notices
Proposed
2013
quotas
g
Diethyltryptamine .......................................................................................................................................................
Difenoxin ....................................................................................................................................................................
Dihydromorphine ........................................................................................................................................................
Dimethyltryptamine ....................................................................................................................................................
Gamma-hydroxybutyric acid ......................................................................................................................................
Heroin ........................................................................................................................................................................
Hydromorphinol ..........................................................................................................................................................
Hydroxypethidine .......................................................................................................................................................
Ibogaine .....................................................................................................................................................................
Lysergic acid diethylamide (LSD) ..............................................................................................................................
Marihuana ..................................................................................................................................................................
Mescaline ...................................................................................................................................................................
Methaqualone ............................................................................................................................................................
Methcathinone ...........................................................................................................................................................
Methyldihydromorphine ..............................................................................................................................................
Morphine-N-oxide ......................................................................................................................................................
N-Benzylpiperazine ....................................................................................................................................................
N,N-Dimethylamphetamine ........................................................................................................................................
N-Ethylamphetamine .................................................................................................................................................
N-Hydroxy-3,4-methylenedioxyamphetamine ............................................................................................................
Noracymethadol .........................................................................................................................................................
Norlevorphanol ...........................................................................................................................................................
Normethadone ...........................................................................................................................................................
Normorphine ..............................................................................................................................................................
Para-fluorofentanyl .....................................................................................................................................................
Phenomorphan ..........................................................................................................................................................
Pholcodine .................................................................................................................................................................
Properidine .................................................................................................................................................................
Psilocybin ...................................................................................................................................................................
Psilocyn ......................................................................................................................................................................
Tetrahydrocannabinols ..............................................................................................................................................
Thiofentanyl ...............................................................................................................................................................
Tilidine ........................................................................................................................................................................
Trimeperidine .............................................................................................................................................................
12
50
3,300,000
18
46,250,000
25
54
2
5
30
21,000
13
10
14
2
655
12
12
12
12
2
52
2
18
2
2
2
2
2
4
491,000
2
10
2
TKELLEY on DSK3SPTVN1PROD with NOTICES
Basic Class—Schedule II
1-Phenylcyclohexylamine ..........................................................................................................................................
1-Piperdinocyclohexanecarbonitrile ...........................................................................................................................
4-Anilino-N-phenethyl-4-piperidine (ANPP) ...............................................................................................................
Alfentanil ....................................................................................................................................................................
Alphaprodine ..............................................................................................................................................................
Amobarbital ................................................................................................................................................................
Amphetamine (for conversion) ..................................................................................................................................
Amphetamine (for sale) .............................................................................................................................................
Carfentanil ..................................................................................................................................................................
Cocaine ......................................................................................................................................................................
Codeine (for conversion) ...........................................................................................................................................
Codeine (for sale) ......................................................................................................................................................
Dextropropoxyphene ..................................................................................................................................................
Dihydrocodeine ..........................................................................................................................................................
Diphenoxylate ............................................................................................................................................................
Ecgonine ....................................................................................................................................................................
Ethylmorphine ............................................................................................................................................................
Fentanyl .....................................................................................................................................................................
Glutethimide ...............................................................................................................................................................
Hydrocodone (for sale) ..............................................................................................................................................
Hydromorphone .........................................................................................................................................................
Isomethadone ............................................................................................................................................................
Levo-alphacetylmethadol (LAAM) ..............................................................................................................................
Levomethorphan ........................................................................................................................................................
Levorphanol ...............................................................................................................................................................
Lisdexamfetamine ......................................................................................................................................................
Meperidine .................................................................................................................................................................
Meperidine Intermediate-A ........................................................................................................................................
Meperidine Intermediate-B ........................................................................................................................................
Meperidine Intermediate-C ........................................................................................................................................
Metazocine .................................................................................................................................................................
Methadone (for sale) .................................................................................................................................................
Methadone Intermediate ............................................................................................................................................
Methamphetamine .....................................................................................................................................................
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21
2,250,000
38,250
3
9
18,375,000
38,000,000
6
240,000
81,250,000
49,506,250
19
250,000
750,000
127,500
3
2,108,750
3
78,750,000
4,535,000
5
4
6
4,500
19,250,000
6,875,000
6
11
6
6
25,000,000
32,500,000
3,912,500
46523
Federal Register / Vol. 77, No. 150 / Friday, August 3, 2012 / Notices
Proposed
2013
quotas
g
[962,500 grams of levo-desoxyephedrine for use in a non-controlled, non-prescription product; 2,888,750 grams
for methamphetamine mostly for conversion to a schedule III product; and 61,250 grams for methamphetamine (for sale)].
Methylphenidate .........................................................................................................................................................
Morphine (for conversion) ..........................................................................................................................................
Morphine (for sale) ....................................................................................................................................................
Nabilone .....................................................................................................................................................................
Noroxymorphone (for conversion) .............................................................................................................................
Noroxymorphone (for sale) ........................................................................................................................................
Opium (powder) .........................................................................................................................................................
Opium (tincture) .........................................................................................................................................................
Oripavine ....................................................................................................................................................................
Oxycodone (for conversion) ......................................................................................................................................
Oxycodone (for sale) .................................................................................................................................................
Oxymorphone (for conversion) ..................................................................................................................................
Oxymorphone (for sale) .............................................................................................................................................
Pentobarbital ..............................................................................................................................................................
Phenazocine ..............................................................................................................................................................
Phencyclidine .............................................................................................................................................................
Phenmetrazine ...........................................................................................................................................................
Phenylacetone ...........................................................................................................................................................
Racemethorphan .......................................................................................................................................................
Remifentanil ...............................................................................................................................................................
Secobarbital ...............................................................................................................................................................
Sufentanil ...................................................................................................................................................................
Tapentadol .................................................................................................................................................................
Thebaine ....................................................................................................................................................................
72,250,000
103,750,000
51,250,000
25,628
9,000,000
508,750
91,250
1,287,500
22,750,000
10,250,000
123,375,000
16,000,000
6,875,000
42,500,000
6
30
3
20,000,000
3
2,500
215,003
6,250
13,500,000
145,000,000
Basic Class—List I Chemicals
Ephedrine (for conversion) ........................................................................................................................................
Ephedrine (for sale) ...................................................................................................................................................
Phenylpropanolamine (for conversion) ......................................................................................................................
Phenylpropanolamine (for sale) .................................................................................................................................
Pseudoephedrine (for sale) .......................................................................................................................................
The Deputy Administrator further
proposes that aggregate production
quotas for all other schedule I and II
controlled substances included in 21
CFR 1308.11 and 1308.12 be established
at zero. Pursuant to 21 CFR 1303.13 and
21 CFR 1315.13, upon consideration of
the relevant factors, the Deputy
Administrator may adjust the 2013
aggregate production quotas and
assessment of annual needs as needed.
TKELLEY on DSK3SPTVN1PROD with NOTICES
Comments
Dated: July 31, 2012.
Thomas M. Harrigan,
Deputy Administrator.
[FR Doc. 2012–19052 Filed 8–2–12; 8:45 am]
BILLING CODE 4410–09–P
Pursuant to 21 CFR 1303.11 and 21
CFR 1315.11, any interested person may
submit written comments on or
objections to these proposed
determinations. Based on comments
received in response to this Notice, the
Deputy Administrator may hold a
public hearing on one or more issues
raised. In the event the Deputy
Administrator decides in his sole
discretion to hold such a hearing, the
Deputy Administrator will publish a
notice of any such hearing in the
Federal Register. After consideration of
any comments and after a hearing, if one
is held, the Deputy Administrator will
VerDate Mar<15>2010
publish in the Federal Register a final
order establishing the 2013 aggregate
production quota for each basic class of
controlled substance and assessment of
annual needs for the list I chemicals
ephedrine, pseudoephedrine, and
phenylpropanolamine.
17:33 Aug 02, 2012
Jkt 226001
DEPARTMENT OF LABOR
Office of the Secretary
Agency Information Collection
Activities; Submission for OMB
Review; Comment Request; Prohibited
Transaction Class Exemption for
Cross-Trades of Securities by Index
and Model-Driven Funds
ACTION:
Notice.
The Department of Labor
(DOL) is submitting the Employee
SUMMARY:
PO 00000
Frm 00151
Fmt 4703
Sfmt 4703
12,000,000
3,200,000
25,700,000
4,400,000
185,000,000
Benefits Security Administration
(EBSA) sponsored information
collection request (ICR) titled,
‘‘Prohibited Transaction Class
Exemption for Cross-Trades of
Securities by Index and Model-Driven
Funds,’’ to the Office of Management
and Budget (OMB) for review and
approval for continued use in
accordance with the Paperwork
Reduction Act (PRA) of 1995 (44 U.S.C.
3501 et seq.).
DATES: Submit comments on or before
September 4, 2012.
ADDRESSES: A copy of this ICR with
applicable supporting documentation;
including a description of the likely
respondents, proposed frequency of
response, and estimated total burden
may be obtained from the RegInfo.gov
Web site, https://www.reginfo.gov/
public/do/PRAMain, on the day
following publication of this notice or
by contacting Michel Smyth by
telephone at 202–693–4129 (this is not
a toll-free number) or sending an email
to DOL_PRA_PUBLIC@dol.gov.
Submit comments about this request
to the Office of Information and
E:\FR\FM\03AUN1.SGM
03AUN1
]]>Agencies
[Federal Register Volume 77, Number 150 (Friday, August 3, 2012)]
[Notices]
[Pages 46519-46523]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-19052]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA-365]
Proposed Aggregate Production Quotas for Schedule I and II
Controlled Substances and Proposed Assessment of Annual Needs for the
List I Chemicals Ephedrine, Pseudoephedrine, and Phenylpropanolamine
for 2013
AGENCY: Drug Enforcement Administration (DEA), Department of Justice.
ACTION: Notice with request for comments.
-----------------------------------------------------------------------
SUMMARY: This notice proposes initial year 2013 aggregate production
quotas for controlled substances in schedules I and II of the
Controlled Substances Act (CSA) and assessment of annual needs for the
list I chemicals ephedrine, pseudoephedrine, and phenylpropanolamine.
DATES: Electronic comments must be submitted and written comments must
be postmarked on or before September 4, 2012. Commenters should be
aware that the electronic Federal Docket Management System will not
accept comments after midnight Eastern Time on the last day of the
comment period.
ADDRESSES: To ensure proper handling of comments, please reference
``Docket No. DEA-365'' on all electronic and written correspondence.
DEA encourages that all comments be submitted electronically through
https://www.regulations.gov using the electronic comment form provided
on that site. An electronic copy of this document is also available at
the https://www.regulations.gov Web site for easy reference. Paper
comments that duplicate the electronic submission are not necessary as
all comments submitted to https://www.regulations.gov will be posted for
public review and are part of the official docket record. Written
comments submitted via regular or express mail should be sent to the
Drug Enforcement Administration, Attention: DEA Federal Register
Representative/ODL, 8701 Morrissette Drive, Springfield, VA 22152.
FOR FURTHER INFORMATION CONTACT: John W. Partridge, Chief, Liaison and
Policy Section, Drug Enforcement Administration, 8701 Morrissette
Drive, Springfield, VA 22152, Telephone: (202) 307-4654.
SUPPLEMENTARY INFORMATION:
[[Page 46520]]
Posting of Public Comments
Please note that all comments received are considered part of the
public record and made available for public inspection online at https://www.regulations.gov and in the DEA's public docket. Such information
includes personal identifying information (such as your name, address,
etc.) voluntarily submitted by the commenter.
If you want to submit personal identifying information (such as
your name, address, etc.) as part of your comment, but do not want it
to be posted online or made available in the public docket, you must
include the phrase ``PERSONAL IDENTIFYING INFORMATION'' in the first
paragraph of your comment. You must also place all the personal
identifying information you do not want posted online or made available
in the public docket in the first paragraph of your comment and
identify what information you want redacted.
If you want to submit confidential business information as part of
your comment, but do not want it to be posted online or made available
in the public docket, you must include the phrase ``CONFIDENTIAL
BUSINESS INFORMATION'' in the first paragraph of your comment. You must
also prominently identify confidential business information to be
redacted within the comment. If a comment has so much confidential
business information that it cannot be effectively redacted, all or
part of that comment may not be posted online or made available in the
public docket.
Personal identifying information and confidential business
information identified and located as set forth above will be redacted,
and the comment, in redacted form, will be posted online and placed in
the DEA's public docket file. Please note that the Freedom of
Information Act applies to all comments received. If you wish to
inspect the agency's public docket file in person by appointment,
please see the For Further Information Contact paragraph.
Background
Section 306 of the CSA (21 U.S.C. 826) requires the Attorney
General to establish aggregate production quotas for each basic class
of controlled substance listed in schedules I and II and for ephedrine,
pseudoephedrine, and phenylpropanolamine. 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.
The proposed year 2013 aggregate production quotas represent those
quantities of schedule I and II controlled substances, and the list I
chemicals ephedrine, pseudoephedrine, and phenylpropanolamine, to be
manufactured in the United States in 2013 to provide 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 include imports of
ephedrine, pseudoephedrine, and phenylpropanolamine but do not include
imports of controlled substances for use in industrial processes.
In determining the proposed 2013 aggregate production quotas and
assessment of annual needs, DEA has taken into account the criteria
that DEA is required to consider in accordance with 21 U.S.C. 826(a),
21 CFR 1303.11 (aggregate production quotas for controlled substances),
and 21 CFR 1315.11 (assessment of annual needs for ephedrine,
pseudoephedrine, and phenylpropanolamine). DEA proposes the aggregate
production quotas and assessment of annual needs for 2013 by
considering (1) total net disposal of the class or chemical by all
manufacturers and chemical importers during the current and two
preceding years; (2) trends in the national rate of net disposal of the
class or chemical; (3) total actual (or estimated) inventories of the
class or chemical and of all substances manufactured from the class or
chemical, and trends in inventory accumulation; (4) projected demand
for such class or chemical as indicated by procurement and chemical
import quotas requested pursuant to 21 CFR 1303.12, 1315.32, and
1315.34; and (5) other factors affecting the medical, scientific,
research, and industrial needs in the United States, lawful export
requirements, and reserve stocks, as the Deputy Administrator finds
relevant. Other factors DEA considered in calculating the aggregate
production quotas, but not the assessment of annual needs, include
product development requirements of both bulk and finished dosage form
manufacturers, and other pertinent information. In determining the
proposed 2013 assessment of annual needs, DEA used the calculation
methodology previously described in the 2010 and 2011 assessment of
annual needs (74 FR 60294 and 75 FR 79407, respectively).
DEA also specifically considered that inventory allowances granted
to individual manufacturers may not always result in the availability
of sufficient quantities to maintain an adequate reserve stock pursuant
to 21 U.S.C. 826(a), as intended. See 21 CFR 1303.24. This would be
concerning if a natural disaster or other unforeseen event resulted in
substantial disruption to the amount of controlled substances available
to provide for legitimate public need. As such, DEA proposes to include
in all schedule II aggregate production quotas, and certain schedule I
aggregate production quotas (gamma-hydroxybutyric acid and
tetrahydrocannabinols), an additional 25% of the estimated medical,
scientific, and research needs as part of the amount necessary to
ensure the establishment and maintenance of reserve stocks. The
resulting established aggregate production quota will reflect these
included amounts. This action will not affect the ability of
manufacturers to maintain inventory allowances as specified by
regulation. DEA expects that maintaining this reserve in certain
established aggregate production quotas will mitigate adverse public
affects if an unforeseen event resulted in substantial disruption to
the amount of controlled substances available to provide for legitimate
public need, as determined by DEA. DEA does not anticipate utilizing
the reserve in the absence of these circumstances.
The Deputy Administrator, therefore, proposes that the year 2013
aggregate production quotas and assessment of annual needs for the
following schedule I and II controlled substances and for the list I
chemicals ephedrine, pseudoephedrine, and phenylpropanolamine,
expressed in grams of anhydrous acid or base, be established as
follows:
[[Page 46521]]
------------------------------------------------------------------------
Proposed 2013 quotas g
------------------------------------------------------------------------
Basic Class--Schedule I
------------------------------------------------------------------------
1-(5-Fluoropentyl)-3-(1-naphthoyl)indole 45
(AM2201).................................
1-(5-Fluoropentyl)-3-(2-iodobenzoyl)indole 45
(AM694)..................................
1-[1-(2-Thienyl)cyclohexyl]piperidine..... 5
1-[2-(4-Morpholinyl)ethyl]-3-(1- 45
naphthoyl)indole (JWH-200)...............
1-Butyl-3-(1-naphthoyl)indole (JWH-073)... 45
1-Cyclohexylethyl-3-(2- 45
methoxyphenylacetyl)indole (SR-18 and RCS-
8).......................................
1-Hexyl-3-(1-naphthoyl)indole (JWH-019)... 45
1-Methyl-4-phenyl-4-propionoxypiperidine.. 2
1-Pentyl-3-(1-naphthoyl)indole (JWH-018 45
and AM678)...............................
1-Pentyl-3-(2-chlorophenylacetyl)indole 45
(JWH-203)................................
1-Pentyl-3-(2-methoxyphenylacetyl)indole 45
(JWH-250)................................
1-Pentyl-3-(4-chloro-1-naphthoyl)indole 45
(JWH-398)................................
1-Pentyl-3-(4-methyl-1-naphthoyl)indole 45
(JWH-122)................................
1-Pentyl-3-[1-(4-methoxynaphthoyl)]indole 45
(JWH-081)................................
1-Pentyl-3-[(4-methoxy)-benzoyl]indole (SR- 45
19, RCS-4)...............................
2-(2,5-Dimethoxy-4-(n)- 15
propylphenyl)ethanamine (2C-P)...........
2-(2,5-Dimethoxy-4-ethylphenyl)ethanamine 15
(2C-E)...................................
2-(2,5-Dimethoxy-4-methylphenyl)ethanamine 15
(2C-D)...................................
2-(2,5-Dimethoxy-4-nitro-phenyl)ethanamine 15
(2C-N)...................................
2-(2,5-Dimethoxyphenyl)ethanamine (2C-H).. 15
2-(4-Chloro-2,5-dimethoxyphenyl)ethanamine 15
(2C-C)...................................
2-(4-Iodo-2,5-dimethoxyphenyl)ethanamine 15
(2C-I)...................................
2,5-Dimethoxy-4-ethylamphetamine (DOET)... 12
2,5-Dimethoxy-4-n-propylthiophenethylamine 12
2,5-Dimethoxyamphetamine.................. 12
2-[4-(Ethylthio)-2,5- 15
dimethoxyphenyl]ethanamine (2C-T-2)......
2-[4-(Isopropylthio)-2,5- 15
dimethoxyphenyl]ethanamine (2C-T-4)......
3-Methylfentanyl.......................... 2
3-Methylthiofentanyl...................... 2
3,4-Methylenedioxyamphetamine (MDA)....... 30
3,4-Methylenedioxy-N-methylcathinone 15
(methylone)..............................
3,4-Methylenedioxy-N-ethylamphetamine 24
(MDEA)...................................
3,4-Methylenedioxymethamphetamine (MDMA).. 35
3,4-Methylenedioxypyrovalerone (MDPV)..... 15
3,4,5-Trimethoxyamphetamine............... 12
4-Bromo-2,5-dimethoxyamphetamine (DOB).... 12
4-Bromo-2,5-dimethoxyphenethylamine (2-CB) 12
4-Methoxyamphetamine...................... 88
4-Methylaminorex.......................... 12
4-Methyl-2,5-dimethoxyamphetamine (DOM)... 12
4-Methyl-N-methylcathinone (mephedrone)... 15
5-(1,1-Dimethylheptyl)-2-[(1R,3S)-3- 68
hydroxycyclohexyl]-phenol................
5-(1,1-Dimethyloctyl)-2-[(1R,3S)-3- 53
hydroxycyclohexyl]-phenol
(cannabicyclohexanol or CP-47, 497 C8-
homolog).................................
5-Methoxy-3,4-methylenedioxyamphetamine... 12
5-Methoxy-N,N-diisopropyltryptamine....... 12
5-Methoxy-N,N-dimethyltryptamine.......... 10
Acetyl-alpha-methylfentanyl............... 2
Acetyldihydrocodeine...................... 2
Acetylmethadol............................ 2
Allylprodine.............................. 2
Alphacetylmethadol........................ 2
Alpha-ethyltryptamine..................... 12
Alphameprodine............................ 2
Alphamethadol............................. 2
Alpha-methylfentanyl...................... 2
Alpha-methylthiofentanyl.................. 2
Alpha-methyltryptamine (AMT).............. 12
Aminorex.................................. 12
Benzylmorphine............................ 2
Betacetylmethadol......................... 2
Beta-hydroxy-3-methylfentanyl............. 2
Beta-hydroxyfentanyl...................... 2
Betameprodine............................. 2
Betamethadol.............................. 2
Betaprodine............................... 2
Bufotenine................................ 3
Cathinone................................. 12
Codeine-N-oxide........................... 602
Desomorphine.............................. 5
[[Page 46522]]
Diethyltryptamine......................... 12
Difenoxin................................. 50
Dihydromorphine........................... 3,300,000
Dimethyltryptamine........................ 18
Gamma-hydroxybutyric acid................. 46,250,000
Heroin.................................... 25
Hydromorphinol............................ 54
Hydroxypethidine.......................... 2
Ibogaine.................................. 5
Lysergic acid diethylamide (LSD).......... 30
Marihuana................................. 21,000
Mescaline................................. 13
Methaqualone.............................. 10
Methcathinone............................. 14
Methyldihydromorphine..................... 2
Morphine-N-oxide.......................... 655
N-Benzylpiperazine........................ 12
N,N-Dimethylamphetamine................... 12
N-Ethylamphetamine........................ 12
N-Hydroxy-3,4-methylenedioxyamphetamine... 12
Noracymethadol............................ 2
Norlevorphanol............................ 52
Normethadone.............................. 2
Normorphine............................... 18
Para-fluorofentanyl....................... 2
Phenomorphan.............................. 2
Pholcodine................................ 2
Properidine............................... 2
Psilocybin................................ 2
Psilocyn.................................. 4
Tetrahydrocannabinols..................... 491,000
Thiofentanyl.............................. 2
Tilidine.................................. 10
Trimeperidine............................. 2
------------------------------------------------------------------------
Basic Class--Schedule II
------------------------------------------------------------------------
1-Phenylcyclohexylamine................... 3
1-Piperdinocyclohexanecarbonitrile........ 21
4-Anilino-N-phenethyl-4-piperidine (ANPP). 2,250,000
Alfentanil................................ 38,250
Alphaprodine.............................. 3
Amobarbital............................... 9
Amphetamine (for conversion).............. 18,375,000
Amphetamine (for sale).................... 38,000,000
Carfentanil............................... 6
Cocaine................................... 240,000
Codeine (for conversion).................. 81,250,000
Codeine (for sale)........................ 49,506,250
Dextropropoxyphene........................ 19
Dihydrocodeine............................ 250,000
Diphenoxylate............................. 750,000
Ecgonine.................................. 127,500
Ethylmorphine............................. 3
Fentanyl.................................. 2,108,750
Glutethimide.............................. 3
Hydrocodone (for sale).................... 78,750,000
Hydromorphone............................. 4,535,000
Isomethadone.............................. 5
Levo-alphacetylmethadol (LAAM)............ 4
Levomethorphan............................ 6
Levorphanol............................... 4,500
Lisdexamfetamine.......................... 19,250,000
Meperidine................................ 6,875,000
Meperidine Intermediate-A................. 6
Meperidine Intermediate-B................. 11
Meperidine Intermediate-C................. 6
Metazocine................................ 6
Methadone (for sale)...................... 25,000,000
Methadone Intermediate.................... 32,500,000
Methamphetamine........................... 3,912,500
------------------------------------------------------------------------
[[Page 46523]]
[962,500 grams of levo-desoxyephedrine for
use in a non-controlled, non-prescription
product; 2,888,750 grams for
methamphetamine mostly for conversion to
a schedule III product; and 61,250 grams
for methamphetamine (for sale)]..........
------------------------------------------------------------------------
Methylphenidate........................... 72,250,000
Morphine (for conversion)................. 103,750,000
Morphine (for sale)....................... 51,250,000
Nabilone.................................. 25,628
Noroxymorphone (for conversion)........... 9,000,000
Noroxymorphone (for sale)................. 508,750
Opium (powder)............................ 91,250
Opium (tincture).......................... 1,287,500
Oripavine................................. 22,750,000
Oxycodone (for conversion)................ 10,250,000
Oxycodone (for sale)...................... 123,375,000
Oxymorphone (for conversion).............. 16,000,000
Oxymorphone (for sale).................... 6,875,000
Pentobarbital............................. 42,500,000
Phenazocine............................... 6
Phencyclidine............................. 30
Phenmetrazine............................. 3
Phenylacetone............................. 20,000,000
Racemethorphan............................ 3
Remifentanil.............................. 2,500
Secobarbital.............................. 215,003
Sufentanil................................ 6,250
Tapentadol................................ 13,500,000
Thebaine.................................. 145,000,000
------------------------------------------------------------------------
Basic Class--List I Chemicals
------------------------------------------------------------------------
Ephedrine (for conversion)................ 12,000,000
Ephedrine (for sale)...................... 3,200,000
Phenylpropanolamine (for conversion)...... 25,700,000
Phenylpropanolamine (for sale)............ 4,400,000
Pseudoephedrine (for sale)................ 185,000,000
------------------------------------------------------------------------
The Deputy Administrator further proposes that aggregate production
quotas for all other schedule I and II controlled substances included
in 21 CFR 1308.11 and 1308.12 be established at zero. Pursuant to 21
CFR 1303.13 and 21 CFR 1315.13, upon consideration of the relevant
factors, the Deputy Administrator may adjust the 2013 aggregate
production quotas and assessment of annual needs as needed.
Comments
Pursuant to 21 CFR 1303.11 and 21 CFR 1315.11, any interested
person may submit written comments on or objections to these proposed
determinations. Based on comments received in response to this Notice,
the Deputy Administrator may hold a public hearing on one or more
issues raised. In the event the Deputy Administrator decides in his
sole discretion to hold such a hearing, the Deputy Administrator will
publish a notice of any such hearing in the Federal Register. After
consideration of any comments and after a hearing, if one is held, the
Deputy Administrator will publish in the Federal Register a final order
establishing the 2013 aggregate production quota for each basic class
of controlled substance and assessment of annual needs for the list I
chemicals ephedrine, pseudoephedrine, and phenylpropanolamine.
Dated: July 31, 2012.
Thomas M. Harrigan,
Deputy Administrator.
[FR Doc. 2012-19052 Filed 8-2-12; 8:45 am]
BILLING CODE 4410-09-P
