Controlled Substances: 2011 Proposed Aggregate Production Quotas, 56810-56814 [2011-23498]
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56810
Federal Register / Vol. 76, No. 178 / Wednesday, September 14, 2011 / Notices
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
mstockstill on DSK4VPTVN1PROD with NOTICES
paragraph.
Background
The proposed 2012 assessment of
annual needs represents those quantities
of ephedrine, pseudoephedrine, and
phenylpropanolamine which may be
manufactured domestically and/or
imported into the United States to
provide adequate supplies of each
chemical to meet the estimated medical,
scientific, research, and industrial needs
of the United States, lawful export
requirements, and the establishment
and maintenance of reserve stocks of
such chemicals.
In proposing the 2012 assessment of
annual needs for ephedrine,
pseudoephedrine, and
phenylpropanolamine, DEA has taken
into account the criteria that DEA is
required to consider in accordance with
21 U.S.C. 826(a) and 21 CFR 1315.11.
DEA proposes the assessment of annual
needs for 2012 by considering (1) Total
net disposal of the chemical by all
manufacturers and importers during the
current and two preceding years; (2)
trends in the national rate of net
disposals of each chemical; (3) total
actual (or estimated) inventories of the
chemical and of all substances
manufactured from the chemical, and
trends in inventory accumulation; (4)
projected demand for each chemical as
indicated by procurement and import
quotas requested pursuant to 21 CFR
1315.32; and (5) other factors affecting
the medical, scientific, research,
industrial, and importation needs in the
United States, lawful export
VerDate Mar<15>2010
19:00 Sep 13, 2011
Jkt 223001
requirements, and reserve stocks, as the
Administrator finds relevant.
Other factors that DEA considered
include trends as derived from
information provided in applications for
import, manufacturing, and
procurement quotas and in import and
export declarations. The inventory,
acquisition (purchases), and disposition
(sales) data as provided by DEA
registered manufacturers and importers
reflects the most current information
available to DEA at the time of
publication of this Notice. DEA notes,
pursuant to 21 CFR 1315.13 the DEA
may adjust the assessments of annual
needs for ephedrine, pseudoephedrine
or phenylpropanolamine that has been
previously fixed pursuant to 21 CFR
1315.11.
Analysis
In determining the 2012 assessments,
DEA has used the calculation
methodology described previously in
the 2010 and 2011 assessment of annual
needs (74 FR 60294 and 75 FR 79407
respectively). Additionally, DEA
considered the total net disposals (i.e.
sales) of these List I chemicals for the
current and preceding two years, actual
and estimated inventories, projected
demand (2012), industrial use, and
export requirements from data provided
by DEA registered manufacturers and
importers in procurement quota
applications (DEA 250), manufacturing
quota applications (DEA 189), import
quota applications (DEA 488), and
declarations for import and export. DEA
notes that the inventory, acquisition
(purchases) and disposition (sales) data
provided by DEA registered
manufacturers and importers reflects the
most current information available.
In finalizing the 2012 assessment of
annual needs for ephedrine,
pseudoephedrine, and
phenylpropanolamine, DEA will
consider the information contained in
additional applications for 2012 import,
manufacturing, and procurement quotas
from DEA registered manufacturers and
importers that DEA receives after the
date of drafting this notice, June 22,
2011, as well as the comments that DEA
receives in response to this proposal.
The Administrator, therefore,
proposes the following assessment of
annual needs for the List I chemicals
ephedrine, pseudoephedrine, and
phenylpropanolamine for 2012,
expressed in kilograms of anhydrous
base:
PO 00000
Frm 00081
Fmt 4703
Sfmt 4703
List I chemicals
Proposed year
2012
assessment of
annual needs
(kg)
Ephedrine (for sale) ..............
Phenylpropanolamine (for
sale) ..................................
Pseudoephedrine (for sale) ..
Phenylpropanolamine (for
conversion) ........................
Ephedrine (for conversion) ...
3,400
5,200
240,000
26,200
12,000
Comments
Pursuant to 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 Administrator may hold a
public hearing on one or more issues
raised. In the event the Administrator
decides in her sole discretion to hold
such a hearing, the 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
Administrator will publish in the
Federal Register a Final Order
determining the assessment of annual
needs for 2012 of ephedrine,
pseudoephedrine, and
phenylpropanolamine.
Dated: September 1, 2011.
Michele M. Leonhart,
Administrator.
[FR Doc. 2011–23505 Filed 9–13–11; 8:45 am]
BILLING CODE 4410–09–P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA–343R]
Controlled Substances: 2011 Proposed
Aggregate Production Quotas
Drug Enforcement
Administration (DEA), Department of
Justice.
ACTION: Notice with request for
comments.
AGENCY:
This notice proposes to adjust
the 2011 aggregate production quotas for
several controlled substances in
schedules I and II of the Controlled
Substances Act (CSA) and separately
proposes to establish aggregate
production quotas for five synthetic
cannabinoids temporarily controlled in
Schedule I.
DATES: Electronic comments must be
submitted and written comments must
SUMMARY:
E:\FR\FM\14SEN1.SGM
14SEN1
Federal Register / Vol. 76, No. 178 / Wednesday, September 14, 2011 / Notices
be postmarked on or before October 14,
2011. 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–343R’’ on all electronic and
written correspondence. DEA
encourages 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. Should
you, however, wish to submit written
comments via regular or express mail,
they should be sent to the Drug
Enforcement Administration, Attention:
DEA Federal Register Representative/
ODL, 8701 Morrissette Drive,
Springfield, VA 22152.
FOR FURTHER INFORMATION CONTACT:
Christine A. Sannerud, Ph.D., Chief, UN
Reporting and Quota Section, Drug
Enforcement Administration, 8701
Morrissette Drive, Springfield, VA
22152, Telephone: (202) 307–7184.
SUPPLEMENTARY INFORMATION:
mstockstill on DSK4VPTVN1PROD with 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.
VerDate Mar<15>2010
19:00 Sep 13, 2011
Jkt 223001
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 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. On September 15, 2010,
a notice of proposed 2011 aggregate
production quotas for certain controlled
substances in schedules I and II was
published in the Federal Register
(75 FR 56137). That notice stipulated
that the Administrator would adjust, as
needed, the quotas in 2011 as provided
for in 21 CFR 1303.13. The 2011
established aggregate production quotas
were subsequently published in the
Federal Register (75 FR 79404) on
December 20, 2010.
Additionally, on March 1, 2011, the
DEA Administrator published a Final
Order which temporarily placed five
synthetic cannabinoids in schedule I:
1-[2-(4-Morpholinyl)ethyl]-3-(1naphthoyl)indole (JWH-200); 1-Butyl-3(1-naphthoyl)indole (JWH-073); 1Pentyl-3-(1-naphthoyl)indole (JWH018); 5-(1,1-Dimethylheptyl)-2-[(1R,3S)3-hydroxycyclohexyl]-phenol (CP47,497); and 5-(1,1-Dimethyloctyl)-2[(1R,3S)-3-hydroxycyclohexyl]-phenol
(cannabicyclohexanol; CP-47,497 C8
PO 00000
Frm 00082
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56811
homologue) (76 FR 11075). That Final
Order stated that quotas for the five
substances would be ‘‘established based
on registrations granted and quota
applications received pursuant to part
1303 of Title 21 of the Code of Federal
Regulations.’’ 76 FR 11075. Aggregate
productions quotas for these
temporarily scheduled substances have
not previously been established.
Analysis for Proposed Revised 2011
Aggregate Production Quotas
DEA now proposes to adjust the
established 2011 aggregate production
quotas for some schedule I and II
controlled substances. In proposing the
adjustment, DEA has taken into account
the criteria that DEA is required to
consider in accordance with 21 CFR
1303.13. DEA proposes the adjustment
of the aggregate production quotas for
basic classes of schedule I and II
controlled substances by considering
(1) Changes in demand for the class,
changes in the national rate of net
disposal for the class, and changes in
the rate of net disposal by the registrants
holding individual manufacturing
quotas for the class; (2) whether any
increased demand or changes in the
national and/or individual rates of net
disposal are temporary, short term, or
long term; (3) whether any increased
demand can be met through existing
inventories, increased individual
manufacturing quotas, or increased
importation without increasing the
aggregate production quota; (4) whether
any decreased demand will result in
excessive inventory accumulation by all
persons registered to handle the class;
and (5) other factors affecting the
medical, scientific, research, and
industrial needs in the United States
and lawful export requirements, as the
Administrator finds relevant.
In determining whether to propose
adjustments to the 2011 aggregate
production quotas, DEA considered
updated information obtained from
2010 year-end inventories, 2010
disposition data submitted by quota
applicants, estimates of the medical
needs of the United States, product
development, and other information
made available to DEA after the initial
aggregate production quotas had been
established. The Administrator,
therefore, proposes to adjust the 2011
aggregate production quotas for some
schedule I and II controlled substances,
expressed in grams of anhydrous acid or
base, as follows:
E:\FR\FM\14SEN1.SGM
14SEN1
56812
Federal Register / Vol. 76, No. 178 / Wednesday, September 14, 2011 / Notices
mstockstill on DSK4VPTVN1PROD with NOTICES
Basic class–schedule I
Previously established initial
2011 quotas
1-Methyl-4-phenyl-4-propionoxypiperidine ....................................................................................
2,5-Dimethoxyamphetamine ..........................................................................................................
2,5-Dimethoxy-4-ethylamphetamine (DOET) ................................................................................
2,5-Dimethoxy-4-n-propylthiophenethylamine ...............................................................................
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 (AMT) ......................................................................................................
Aminorex .......................................................................................................................................
Benzylmorphine .............................................................................................................................
Betacetylmethadol .........................................................................................................................
Beta-hydroxy-3-methylfentanyl ......................................................................................................
Beta-hydroxyfentanyl .....................................................................................................................
Betameprodine ..............................................................................................................................
Betamethadol ................................................................................................................................
Betaprodine ...................................................................................................................................
Bufotenine .....................................................................................................................................
Cathinone ......................................................................................................................................
Codeine-N-oxide ............................................................................................................................
Diethyltryptamine ...........................................................................................................................
Difenoxin ........................................................................................................................................
Dihydromorphine ...........................................................................................................................
Dimethyltryptamine ........................................................................................................................
Gamma-hydroxybutyric acid ..........................................................................................................
Heroin ............................................................................................................................................
Hydromorphinol .............................................................................................................................
Hydroxypethidine ...........................................................................................................................
Ibogaine .........................................................................................................................................
Lysergic acid diethylamide (LSD) .................................................................................................
Marihuana ......................................................................................................................................
Mescaline ......................................................................................................................................
Methaqualone ................................................................................................................................
Methcathinone ...............................................................................................................................
Methyldihydromorphine .................................................................................................................
Morphine-N-oxide ..........................................................................................................................
N-Benzylpiperazine .......................................................................................................................
N,N-Dimethylamphetamine ...........................................................................................................
N-Ethylamphetamine .....................................................................................................................
N-Hydroxy-3,4-methylenedioxyamphetamine ...............................................................................
Noracymethadol ............................................................................................................................
Norlevorphanol ..............................................................................................................................
Normethadone ...............................................................................................................................
Normorphine ..................................................................................................................................
Para-fluorofentanyl ........................................................................................................................
Phenomorphan ..............................................................................................................................
Pholcodine .....................................................................................................................................
Psilocybin ......................................................................................................................................
Psilocyn .........................................................................................................................................
Tetrahydrocannabinols ..................................................................................................................
Thiofentanyl ...................................................................................................................................
Tilidine ...........................................................................................................................................
Trimeperidine .................................................................................................................................
2
2
2
2
2
2
22
15
22
2
2
2
77
2
2
2
2
2
2
2
2
2
2
2
2
2
2
2
2
2
2
2
2
2
2
2
3
4
602
2
3,000
3,608,000
7
3,000,000
20
2
2
5
16
21,000
5
10
4
2
605
2
2
2
2
2
52
2
18
2
2
2
2
2
393,000
2
10
2
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14SEN1
Proposed
adjusted
2011 quotas
No Change.
No Change.
No Change.
No Change.
No Change.
No Change.
No Change.
No Change.
No Change.
No Change.
No Change.
No Change.
No Change.
No Change.
No Change.
No Change.
No Change.
No Change.
No Change.
No Change.
No Change.
No Change.
No Change.
No Change.
No Change.
No Change.
No Change.
No Change.
No Change.
No Change.
No Change.
No Change.
No Change.
No Change.
No Change.
No Change.
No Change.
No Change.
No Change.
No Change.
50 g.
No Change.
No Change.
5,434,000 g.
No Change.
No Change.
No Change.
No Change.
No Change.
No Change.
No Change.
No Change.
No Change.
No Change.
No Change.
No Change.
No Change.
No Change.
No Change.
No Change.
No Change.
No Change.
No Change.
No Change.
No Change.
No Change.
No Change.
No Change.
No Change.
No Change.
No Change.
No Change.
56813
Federal Register / Vol. 76, No. 178 / Wednesday, September 14, 2011 / Notices
Basic class—schedule II
Previously established initial
2011 quotas
1-Phenylcyclohexylamine ..............................................................................................................
1-Piperdinocyclohexanecarbonitrile ...............................................................................................
4-Anilino-N-phenethyl-4-piperidine (ANPP) ...................................................................................
Alfentanil ........................................................................................................................................
Alphaprodine .................................................................................................................................
Amobarbital ...................................................................................................................................
Amphetamine (for conversion) ......................................................................................................
Amphetamine (for sale) .................................................................................................................
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 .........................................................................................................................
2
2
2,500,000
8,000
2
40,007
7,500,000
18,600,000
247,000
65,000,000
39,605,000
92,000,000
800,000
827,000
83,000
2
1,428,000
2
55,000,000
3,455,000
11
3
5
10,000
9,000,000
6,600,000
3
7
3
5
20,000,000
26,000,000
3,130,000
g
g
g
g
g
g
g
g
g
g
g
g
g
g
g
g
g
g
g
g
g
g
g
g
g
g
g
g
g
g
g
g
g
Proposed
adjusted
2011 quotas
No Change.
No Change.
1,800,000 g.
11,600 g.
No Change.
No Change.
8,500,000 g.
25,300,000 g.
216,000 g.
No Change.
No Change.
7 g.
255,000 g.
500,000 g.
No Change.
No Change.
No Change.
No Change.
59,000,000 g.
No Change.
2 g.
No Change.
2 g.
3,600 g.
10,400,000 g.
5,200,000 g.
No Change.
No Change.
No Change.
No Change.
No Change.
No Change.
No Change.
[750,000 grams of levo-desoxyephedrine for use in a non-controlled, non-prescription product; 2,331,000 grams for methamphetamine mostly for
conversion to a schedule III product; and 49,000 grams for methamphetamine (for sale)]
mstockstill on DSK4VPTVN1PROD with NOTICES
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 ........................................................................................................................................
Aggregate production quotas for all
other schedule I and II controlled
substances included in 21 CFR 1308.11
and 1308.12 remain at zero.
VerDate Mar<15>2010
19:00 Sep 13, 2011
Jkt 223001
Analysis for Proposed Aggregate
Production Quotas for Temporarily
Scheduled Substances
The proposed year 2011 aggregate
production quotas represent those
quantities of controlled substances that
may be produced in the United States in
PO 00000
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Sfmt 4703
50,000,000
83,000,000
39,000,000
10,502
9,000,000
401,000
230,000
1,500,000
15,000,000
5,600,000
105,500,000
12,800,000
3,070,000
28,000,000
5
24
2
8,000,000
2
2,500
260,002
7,000
1,000,000
126,000,000
g
g
g
g
g
g
g
g
g
g
g
g
g
g
g
g
g
g
g
g
g
g
g
g
56,000,000 g.
70,000,000 g.
No Change.
No Change.
7,200,000 g.
No Change.
63,000 g.
1,000,000 g.
8,000,000 g.
No Change.
98,000,000 g.
No Change.
No Change.
31,000,000 g.
No Change.
No Change.
No Change.
No Change.
No Change.
No Change.
336,002 g.
5,000 g.
403,000 g.
116,000,000 g.
2011 to provide adequate supplies of
each substance for 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
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14SEN1
56814
Federal Register / Vol. 76, No. 178 / Wednesday, September 14, 2011 / Notices
controlled substances for use in
industrial processes.
In determining the year 2011
aggregate production quotas for the five
temporarily scheduled controlled
substances listed below, the
Administrator considered the following
factors, in accordance with 21 U.S.C.
826(a) and 21 CFR 1303.11: Total
estimated net disposal of each substance
by all manufacturers; total estimated
inventories of the class and of all
substances manufactured in the class;
projected demand for such class as
indicated by procurement quotas
requested pursuant to 21 CFR 1303.12;
and other factors affecting medical,
scientific, research, and industrial needs
of the United States and lawful export
requirements.
DEA has received applications for
registration and quota for the
temporarily scheduled controlled
substances listed below. In examining
the information provided by the
applicant(s), along with other
information, DEA finds that there is a
current need for these substances. The
Administrator therefore proposes that
the year 2011 aggregate production
quotas for the following controlled
substances, expressed in grams of
anhydrous acid or base, be established
as follows:
Proposed
2011
quotas
Basic class–schedule I
1-[2-(4-Morpholinyl)ethyl]-3-(1-naphthoyl)indole (JWH–200) ....................................................................................................................
1-Butyl-3-(1-naphthoyl)indole (JWH–073) .................................................................................................................................................
1-Pentyl-3-(1-naphthoyl)indole (JWH–018) ...............................................................................................................................................
5-(1,1-Dimethylheptyl)-2-[(1R,3S)-3-hydroxycyclohexyl]-phenol (CP–47,497) ..........................................................................................
5-(1,1-Dimethyloctyl)-2-[(1R,3S)-3-hydroxycyclohexyl]-phenol (cannabicyclohexanol; CP–47,497 C8 homologue) ...............................
Pursuant to 21 CFR part 1303, the
Administrator may adjust the 2011
aggregate production quotas and
individual manufacturing quotas
allocated for the year.
Comments
Pursuant to 21 CFR 1303.11 and
1303.13, any interested person may
submit written comments on or
objections to these proposed
determinations. Based on comments
received in response to this Notice, the
Administrator may hold a public
hearing on one or more issues raised. In
the event the Administrator decides in
her sole discretion to hold such a
hearing, the 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 Administrator will publish
in the Federal Register a Final Order
determining any adjustment of the
aggregate production quota.
Dated: September 2, 2011.
Michele M. Leonhart,
Administrator.
[FR Doc. 2011–23498 Filed 9–13–11; 8:45 am]
BILLING CODE 4410–09–P
DEPARTMENT OF LABOR
mstockstill on DSK4VPTVN1PROD with NOTICES
Office of the Secretary
Agency Information Collection
Activities; Submission for OMB
Review; Comment Request; Enhanced
Traditional Jobs Demonstration
ACTION:
Notice.
19:00 Sep 13, 2011
This ICR
would implement Enhanced
Transitional Jobs Demonstration
reporting and recordkeeping
SUPPLEMENTARY INFORMATION:
The Department of Labor
(DOL) is submitting the Employment
and Training Administration (ETA)
SUMMARY:
VerDate Mar<15>2010
sponsored and proposed information
collection request (ICR) titled,
‘‘Enhanced Traditional Jobs
Demonstration,’’ to the Office of
Management and Budget (OMB) for
review and approval for use in
accordance with the Paperwork
Reduction Act (PRA) of 1995 (44 U.S.C.
3501 et seq.).
DATES: Submit comments on or before
October 14, 2011.
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 e-mail
to DOL_PRA_PUBLIC@dol.gov.
Submit comments about this request
to the Office of Information and
Regulatory Affairs, Attn: OMB Desk
Officer for the Department of Labor,
Employment and Training
Administration (ETA), Office of
Management and Budget, Room 10235,
Washington, DC 20503, Telephone:
202–395–6929/Fax: 202–395–6881
(these are not toll-free numbers), e-mail:
OIRA_submission@omb.eop.gov.
FOR FURTHER INFORMATION CONTACT:
Michel Smyth by telephone at 202–693–
4129 (this is not a toll-free number) or
by e-mail at
DOL_PRA_PUBLIC@dol.gov.
Jkt 223001
PO 00000
Frm 00085
Fmt 4703
Sfmt 4703
45
45
45
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53
g
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g
g
g
requirements. This reporting structure
features standardized data collection for
program participants and quarterly
narrative, performance, and
management information system report
formats. All data collection and
reporting will be done by grantee
organizations (state or local government
or faith-based and community
organizations) or their sub-grantees.
This information collection is subject
to the PRA. A Federal agency generally
cannot conduct or sponsor a collection
of information, and the public is
generally not required to respond to an
information collection, unless it is
approved by the OMB under the PRA
and displays a currently valid OMB
Control Number. In addition,
notwithstanding any other provisions of
law, no person shall generally be subject
to penalty for failing to comply with a
collection of information if the
collection of information does not
display a valid OMB Control Number.
See 5 CFR 1320.5(a) and 1320.6. For
additional information, see the related
notice published in the Federal Register
on June 1, 2011 (76 FR 31639).
Interested parties are encouraged to
send comments to the OMB, Office of
Information and Regulatory Affairs at
the address shown in the ADDRESSES
section within 30 days of publication of
this notice in the Federal Register. In
order to help ensure appropriate
consideration, comments should
mention OMB ICR Reference Number
201108–1205–002. The OMB is
particularly interested in comments
that:
• Evaluate whether the proposed
collection of information is necessary
for the proper performance of the
functions of the agency, including
E:\FR\FM\14SEN1.SGM
14SEN1
]]>Agencies
[Federal Register Volume 76, Number 178 (Wednesday, September 14, 2011)]
[Notices]
[Pages 56810-56814]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-23498]
-----------------------------------------------------------------------
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA-343R]
Controlled Substances: 2011 Proposed Aggregate Production Quotas
AGENCY: Drug Enforcement Administration (DEA), Department of Justice.
ACTION: Notice with request for comments.
-----------------------------------------------------------------------
SUMMARY: This notice proposes to adjust the 2011 aggregate production
quotas for several controlled substances in schedules I and II of the
Controlled Substances Act (CSA) and separately proposes to establish
aggregate production quotas for five synthetic cannabinoids temporarily
controlled in Schedule I.
DATES: Electronic comments must be submitted and written comments must
[[Page 56811]]
be postmarked on or before October 14, 2011. 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-343R'' on all electronic and written correspondence.
DEA encourages 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. Should you,
however, wish to submit written comments via regular or express mail,
they should be sent to the Drug Enforcement Administration, Attention:
DEA Federal Register Representative/ODL, 8701 Morrissette Drive,
Springfield, VA 22152.
FOR FURTHER INFORMATION CONTACT: Christine A. Sannerud, Ph.D., Chief,
UN Reporting and Quota Section, Drug Enforcement Administration, 8701
Morrissette Drive, Springfield, VA 22152, Telephone: (202) 307-7184.
SUPPLEMENTARY INFORMATION:
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 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. On
September 15, 2010, a notice of proposed 2011 aggregate production
quotas for certain controlled substances in schedules I and II was
published in the Federal Register (75 FR 56137). That notice stipulated
that the Administrator would adjust, as needed, the quotas in 2011 as
provided for in 21 CFR 1303.13. The 2011 established aggregate
production quotas were subsequently published in the Federal Register
(75 FR 79404) on December 20, 2010.
Additionally, on March 1, 2011, the DEA Administrator published a
Final Order which temporarily placed five synthetic cannabinoids in
schedule I: 1-[2-(4-Morpholinyl)ethyl]-3-(1-naphthoyl)indole (JWH-200);
1-Butyl-3-(1-naphthoyl)indole (JWH-073); 1-Pentyl-3-(1-naphthoyl)indole
(JWH-018); 5-(1,1-Dimethylheptyl)-2-[(1R,3S)-3-hydroxycyclohexyl]-
phenol (CP-47,497); and 5-(1,1-Dimethyloctyl)-2-[(1R,3S)-3-
hydroxycyclohexyl]-phenol (cannabicyclohexanol; CP-47,497 C8 homologue)
(76 FR 11075). That Final Order stated that quotas for the five
substances would be ``established based on registrations granted and
quota applications received pursuant to part 1303 of Title 21 of the
Code of Federal Regulations.'' 76 FR 11075. Aggregate productions
quotas for these temporarily scheduled substances have not previously
been established.
Analysis for Proposed Revised 2011 Aggregate Production Quotas
DEA now proposes to adjust the established 2011 aggregate
production quotas for some schedule I and II controlled substances. In
proposing the adjustment, DEA has taken into account the criteria that
DEA is required to consider in accordance with 21 CFR 1303.13. DEA
proposes the adjustment of the aggregate production quotas for basic
classes of schedule I and II controlled substances by considering (1)
Changes in demand for the class, changes in the national rate of net
disposal for the class, and changes in the rate of net disposal by the
registrants holding individual manufacturing quotas for the class; (2)
whether any increased demand or changes in the national and/or
individual rates of net disposal are temporary, short term, or long
term; (3) whether any increased demand can be met through existing
inventories, increased individual manufacturing quotas, or increased
importation without increasing the aggregate production quota; (4)
whether any decreased demand will result in excessive inventory
accumulation by all persons registered to handle the class; and (5)
other factors affecting the medical, scientific, research, and
industrial needs in the United States and lawful export requirements,
as the Administrator finds relevant.
In determining whether to propose adjustments to the 2011 aggregate
production quotas, DEA considered updated information obtained from
2010 year-end inventories, 2010 disposition data submitted by quota
applicants, estimates of the medical needs of the United States,
product development, and other information made available to DEA after
the initial aggregate production quotas had been established. The
Administrator, therefore, proposes to adjust the 2011 aggregate
production quotas for some schedule I and II controlled substances,
expressed in grams of anhydrous acid or base, as follows:
[[Page 56812]]
------------------------------------------------------------------------
Previously
established Proposed adjusted
Basic class-schedule I initial 2011 2011 quotas
quotas
------------------------------------------------------------------------
1-Methyl-4-phenyl-4- 2 g No Change.
propionoxypiperidine.
2,5-Dimethoxyamphetamine........... 2 g No Change.
2,5-Dimethoxy-4-ethylamphetamine 2 g No Change.
(DOET).
2,5-Dimethoxy-4-n- 2 g No Change.
propylthiophenethylamine.
3-Methylfentanyl................... 2 g No Change.
3-Methylthiofentanyl............... 2 g No Change.
3,4-Methylenedioxyamphetamine (MDA) 22 g No Change.
3,4-Methylenedioxy-N- 15 g No Change.
ethylamphetamine (MDEA).
3,4-Methylenedioxymethamphetamine 22 g No Change.
(MDMA).
3,4,5-Trimethoxyamphetamine........ 2 g No Change.
4-Bromo-2,5-dimethoxyamphetamine 2 g No Change.
(DOB).
4-Bromo-2,5-dimethoxyphenethylamine 2 g No Change.
(2-CB).
4-Methoxyamphetamine............... 77 g No Change.
4-Methylaminorex................... 2 g No Change.
4-Methyl-2,5-dimethoxyamphetamine 2 g No Change.
(DOM).
5-Methoxy-3,4- 2 g No Change.
methylenedioxyamphetamine.
5-Methoxy-N,N-diisopropyltryptamine 2 g No Change.
Acetyl-alpha-methylfentanyl........ 2 g No Change.
Acetyldihydrocodeine............... 2 g No Change.
Acetylmethadol..................... 2 g No Change.
Allylprodine....................... 2 g No Change.
Alphacetylmethadol................. 2 g No Change.
Alpha-ethyltryptamine.............. 2 g No Change.
Alphameprodine..................... 2 g No Change.
Alphamethadol...................... 2 g No Change.
Alpha-methylfentanyl............... 2 g No Change.
Alpha-methylthiofentanyl........... 2 g No Change.
Alpha-methyltryptamine (AMT)....... 2 g No Change.
Aminorex........................... 2 g No Change.
Benzylmorphine..................... 2 g No Change.
Betacetylmethadol.................. 2 g No Change.
Beta-hydroxy-3-methylfentanyl...... 2 g No Change.
Beta-hydroxyfentanyl............... 2 g No Change.
Betameprodine...................... 2 g No Change.
Betamethadol....................... 2 g No Change.
Betaprodine........................ 2 g No Change.
Bufotenine......................... 3 g No Change.
Cathinone.......................... 4 g No Change.
Codeine-N-oxide.................... 602 g No Change.
Diethyltryptamine.................. 2 g No Change.
Difenoxin.......................... 3,000 g 50 g.
Dihydromorphine.................... 3,608,000 g No Change.
Dimethyltryptamine................. 7 g No Change.
Gamma-hydroxybutyric acid.......... 3,000,000 g 5,434,000 g.
Heroin............................. 20 g No Change.
Hydromorphinol..................... 2 g No Change.
Hydroxypethidine................... 2 g No Change.
Ibogaine........................... 5 g No Change.
Lysergic acid diethylamide (LSD)... 16 g No Change.
Marihuana.......................... 21,000 g No Change.
Mescaline.......................... 5 g No Change.
Methaqualone....................... 10 g No Change.
Methcathinone...................... 4 g No Change.
Methyldihydromorphine.............. 2 g No Change.
Morphine-N-oxide................... 605 g No Change.
N-Benzylpiperazine................. 2 g No Change.
N,N-Dimethylamphetamine............ 2 g No Change.
N-Ethylamphetamine................. 2 g No Change.
N-Hydroxy-3,4- 2 g No Change.
methylenedioxyamphetamine.
Noracymethadol..................... 2 g No Change.
Norlevorphanol..................... 52 g No Change.
Normethadone....................... 2 g No Change.
Normorphine........................ 18 g No Change.
Para-fluorofentanyl................ 2 g No Change.
Phenomorphan....................... 2 g No Change.
Pholcodine......................... 2 g No Change.
Psilocybin......................... 2 g No Change.
Psilocyn........................... 2 g No Change.
Tetrahydrocannabinols.............. 393,000 g No Change.
Thiofentanyl....................... 2 g No Change.
Tilidine........................... 10 g No Change.
Trimeperidine...................... 2 g No Change.
------------------------------------------------------------------------
[[Page 56813]]
------------------------------------------------------------------------
Previously
established Proposed adjusted
Basic class--schedule II initial 2011 2011 quotas
quotas
------------------------------------------------------------------------
1-Phenylcyclohexylamine............ 2 g No Change.
1-Piperdinocyclohexanecarbonitrile. 2 g No Change.
4-Anilino-N-phenethyl-4-piperidine 2,500,000 g 1,800,000 g.
(ANPP).
Alfentanil......................... 8,000 g 11,600 g.
Alphaprodine....................... 2 g No Change.
Amobarbital........................ 40,007 g No Change.
Amphetamine (for conversion)....... 7,500,000 g 8,500,000 g.
Amphetamine (for sale)............. 18,600,000 g 25,300,000 g.
Cocaine............................ 247,000 g 216,000 g.
Codeine (for conversion)........... 65,000,000 g No Change.
Codeine (for sale)................. 39,605,000 g No Change.
Dextropropoxyphene................. 92,000,000 g 7 g.
Dihydrocodeine..................... 800,000 g 255,000 g.
Diphenoxylate...................... 827,000 g 500,000 g.
Ecgonine........................... 83,000 g No Change.
Ethylmorphine...................... 2 g No Change.
Fentanyl........................... 1,428,000 g No Change.
Glutethimide....................... 2 g No Change.
Hydrocodone (for sale)............. 55,000,000 g 59,000,000 g.
Hydromorphone...................... 3,455,000 g No Change.
Isomethadone....................... 11 g 2 g.
Levo-alphacetylmethadol (LAAM)..... 3 g No Change.
Levomethorphan..................... 5 g 2 g.
Levorphanol........................ 10,000 g 3,600 g.
Lisdexamfetamine................... 9,000,000 g 10,400,000 g.
Meperidine......................... 6,600,000 g 5,200,000 g.
Meperidine Intermediate-A.......... 3 g No Change.
Meperidine Intermediate-B.......... 7 g No Change.
Meperidine Intermediate-C.......... 3 g No Change.
Metazocine......................... 5 g No Change.
Methadone (for sale)............... 20,000,000 g No Change.
Methadone Intermediate............. 26,000,000 g No Change.
Methamphetamine.................... 3,130,000 g No Change.
------------------------------------------------------------------------
[750,000 grams of levo-desoxyephedrine for use in a non-controlled, non-
prescription product; 2,331,000 grams for methamphetamine mostly for
conversion to a schedule III product; and 49,000 grams for
methamphetamine (for sale)]
------------------------------------------------------------------------
Methylphenidate.................... 50,000,000 g 56,000,000 g.
Morphine (for conversion).......... 83,000,000 g 70,000,000 g.
Morphine (for sale)................ 39,000,000 g No Change.
Nabilone........................... 10,502 g No Change.
Noroxymorphone (for conversion).... 9,000,000 g 7,200,000 g.
Noroxymorphone (for sale).......... 401,000 g No Change.
Opium (powder)..................... 230,000 g 63,000 g.
Opium (tincture)................... 1,500,000 g 1,000,000 g.
Oripavine.......................... 15,000,000 g 8,000,000 g.
Oxycodone (for conversion)......... 5,600,000 g No Change.
Oxycodone (for sale)............... 105,500,000 g 98,000,000 g.
Oxymorphone (for conversion)....... 12,800,000 g No Change.
Oxymorphone (for sale)............. 3,070,000 g No Change.
Pentobarbital...................... 28,000,000 g 31,000,000 g.
Phenazocine........................ 5 g No Change.
Phencyclidine...................... 24 g No Change.
Phenmetrazine...................... 2 g No Change.
Phenylacetone...................... 8,000,000 g No Change.
Racemethorphan..................... 2 g No Change.
Remifentanil....................... 2,500 g No Change.
Secobarbital....................... 260,002 g 336,002 g.
Sufentanil......................... 7,000 g 5,000 g.
Tapentadol......................... 1,000,000 g 403,000 g.
Thebaine........................... 126,000,000 g 116,000,000 g.
------------------------------------------------------------------------
Aggregate production quotas for all other schedule I and II
controlled substances included in 21 CFR 1308.11 and 1308.12 remain at
zero.
Analysis for Proposed Aggregate Production Quotas for Temporarily
Scheduled Substances
The proposed year 2011 aggregate production quotas represent those
quantities of controlled substances that may be produced in the United
States in 2011 to provide adequate supplies of each substance for
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
[[Page 56814]]
controlled substances for use in industrial processes.
In determining the year 2011 aggregate production quotas for the
five temporarily scheduled controlled substances listed below, the
Administrator considered the following factors, in accordance with 21
U.S.C. 826(a) and 21 CFR 1303.11: Total estimated net disposal of each
substance by all manufacturers; total estimated inventories of the
class and of all substances manufactured in the class; projected demand
for such class as indicated by procurement quotas requested pursuant to
21 CFR 1303.12; and other factors affecting medical, scientific,
research, and industrial needs of the United States and lawful export
requirements.
DEA has received applications for registration and quota for the
temporarily scheduled controlled substances listed below. In examining
the information provided by the applicant(s), along with other
information, DEA finds that there is a current need for these
substances. The Administrator therefore proposes that the year 2011
aggregate production quotas for the following controlled substances,
expressed in grams of anhydrous acid or base, be established as
follows:
------------------------------------------------------------------------
Basic class-schedule I Proposed 2011 quotas
------------------------------------------------------------------------
1-[2-(4-Morpholinyl)ethyl]-3-(1- 45 g
naphthoyl)indole (JWH-200).
1-Butyl-3-(1-naphthoyl)indole (JWH-073)..... 45 g
1-Pentyl-3-(1-naphthoyl)indole (JWH-018).... 45 g
5-(1,1-Dimethylheptyl)-2-[(1R,3S)-3- 68 g
hydroxycyclohexyl]-phenol (CP-47,497).
5-(1,1-Dimethyloctyl)-2-[(1R,3S)-3- 53 g
hydroxycyclohexyl]-phenol
(cannabicyclohexanol; CP-47,497 C8
homologue).
------------------------------------------------------------------------
Pursuant to 21 CFR part 1303, the Administrator may adjust the 2011
aggregate production quotas and individual manufacturing quotas
allocated for the year.
Comments
Pursuant to 21 CFR 1303.11 and 1303.13, any interested person may
submit written comments on or objections to these proposed
determinations. Based on comments received in response to this Notice,
the Administrator may hold a public hearing on one or more issues
raised. In the event the Administrator decides in her sole discretion
to hold such a hearing, the 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 Administrator will
publish in the Federal Register a Final Order determining any
adjustment of the aggregate production quota.
Dated: September 2, 2011.
Michele M. Leonhart,
Administrator.
[FR Doc. 2011-23498 Filed 9-13-11; 8:45 am]
BILLING CODE 4410-09-P
