Proposed Adjustments to the Aggregate Production Quotas for Schedule I and II Controlled Substances and Assessment of Annual Needs for the List I Chemicals Ephedrine, Pseudoephedrine, and Phenylpropanolamine for 2013, 37237-37241 [2013-14723]
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Federal Register / Vol. 78, No. 119 / Thursday, June 20, 2013 / Notices
INTERNATIONAL TRADE
COMMISSION
[USITC SE–13–015]
Sunshine Act Meeting Notice
United
States International Trade Commission.
TIME AND DATE: June 28, 2013 at 11:00
a.m.
PLACE: Room 101, 500 E Street SW.,
Washington, DC 20436, Telephone:
(202) 205–2000.
STATUS: Open to the public.
MATTERS TO BE CONSIDERED:
1. Agendas for future meetings: None.
2. Minutes.
3. Ratification List.
4. Vote in Inv. Nos. 731–TA–1210–1212
(Preliminary) (Welded Stainless
Steel Pressure Pipe from Malaysia,
Thailand, and Vietnam). The
Commission is currently scheduled
to transmit its determinations to the
Secretary of Commerce on or before
July 1, 2013; Commissioners’
opinions are currently scheduled to
be transmitted to the Secretary of
Commerce on or before July 9, 2013.
5. Outstanding action jackets: None.
In accordance with Commission
policy, subject matter listed above, not
disposed of at the scheduled meeting,
may be carried over to the agenda of the
following meeting.
AGENCY HOLDING THE MEETING:
Issued: June 18, 2013.
By order of the Commission.
William R. Bishop,
Supervisory Hearings and Information
Officer.
[FR Doc. 2013–14807 Filed 6–18–13; 11:15 am]
BILLING CODE 7020–02–P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA–365]
Proposed Adjustments to the
Aggregate Production Quotas for
Schedule I and II Controlled
Substances and Assessment of
Annual Needs for the List I Chemicals
Ephedrine, Pseudoephedrine, and
Phenylpropanolamine for 2013
Drug Enforcement
Administration (DEA), Department of
Justice.
ACTION: Notice with request for
comments.
TKELLEY on DSK3SPTVN1PROD with NOTICES
AGENCY:
This notice proposes to adjust
the 2013 aggregate production quotas for
several controlled substances in
schedules I and II of the Controlled
SUMMARY:
VerDate Mar<15>2010
17:01 Jun 19, 2013
Jkt 229001
Substances Act (CSA) and assessment of
annual needs for the list I chemicals
ephedrine, pseudoephedrine, and
phenylpropanolamine, as well as to
establish the 2013 aggregate production
quotas for three recently temporarily
scheduled substances.
DATES: Electronic comments must be
submitted and written comments must
be postmarked on or before July 22,
2013. 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 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 https://
www.regulations.gov for easy reference.
Paper comments that duplicate the
electronic submission are not necessary
and are strongly discouraged as all
comments submitted to
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: John
W. Partridge, Executive Assistant, Office
of Diversion Control, Drug Enforcement
Administration, 8701 Morrissette Drive,
Springfield, VA 22152; Telephone: (202)
307–7165.
SUPPLEMENTARY INFORMATION:
Posting of Public Comments
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
PO 00000
Frm 00039
Fmt 4703
Sfmt 4703
37237
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 through 28
CFR 0.100. The Administrator, in turn,
has redelegated this function to the
Deputy Administrator, pursuant to 28
CFR 0.104. DEA published the 2013
established aggregate production quotas
for controlled substances in schedules I
and II and assessment of annual needs
for the list I chemicals ephedrine,
pseudoephedrine, and
phenylpropanolamine in the Federal
Register (77 FR 59980) on October 1,
2012. That notice stipulated that, as
provided for in 21 CFR 1303.13 and 21
CFR 1315.13, all aggregate production
quotas and assessments of annual need
are subject to adjustment.
Analysis for Proposed Aggregate
Production Quotas for Temporarily
Scheduled Substances
On May 16, 2013, the Deputy
Administrator issued a final order to
temporarily schedule three synthetic
cannabinoids in schedule I of the CSA:
(1-Pentyl-1H-indol-3-yl)(2,2,3,3tetramethylcyclopropyl)methanone
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20JNN1
37238
Federal Register / Vol. 78, No. 119 / Thursday, June 20, 2013 / Notices
TKELLEY on DSK3SPTVN1PROD with NOTICES
(UR–144); [1-(5-fluoro-pentyl)-1H-indol3-yl](2,2,3,3tetramethylcyclopropyl)methanone
(XLR11); and N-(1-adamantyl)-1-pentyl1H-indazole-3-carboxamide (AKB48).
See 78 FR 28735. DEA has received
applications for registration and quota
for these temporarily scheduled
substances. In examining the
information provided by the applicants,
along with other information, DEA finds
that there is a current need for these
substances. Aggregate production quotas
represent those quantities of schedule I
and II controlled substances 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. As such, pursuant to 21
U.S.C. 826(a), the Deputy Administrator
must determine the total quantity and
establish production quotas for each of
the three temporarily scheduled
substances.
In making this determination, the
Deputy Administrator has taken into
account the criteria that DEA is required
to consider in accordance with 21
U.S.C. 826(a) and 21 CFR 1303.11. DEA
proposes the aggregate production
quotas for these three temporarily
scheduled substances by considering:
(1) Total estimated net disposal of each
substance by all manufacturers; (2)
estimated trends in the national rate of
net disposal; (3) total estimated
inventories of the basic class and of all
substances manufactured from the class;
(4) projected demand for each class as
indicated by procurement quotas
requested pursuant to 21 CFR 1303.12;
and (5) other factors affecting medical,
scientific, research, and industrial needs
of the United States and lawful export
requirements, as the Deputy
Administrator finds relevant. These
quotas do not include imports of
controlled substances for use in
industrial processes.
Analysis for Proposed Revised 2013
Aggregate Production Quotas and
Assessment of Annual Needs
DEA proposes to adjust the
established 2013 aggregate production
quotas for some schedule I and II
controlled substances to be
manufactured in the United States in
VerDate Mar<15>2010
17:01 Jun 19, 2013
Jkt 229001
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 do not
include imports of controlled
substances for use in industrial
processes. DEA is not proposing to
adjust the assessment of annual needs
for the list I chemicals ephedrine,
pseudoephedrine, and
phenylpropanolamine at this time.
In proposing the adjustment, DEA has
taken into account the criteria that DEA
is required to consider in accordance
with 21 CFR 1303.13 and 21 CFR
1315.13. DEA determines whether to
propose an adjustment of the aggregate
production quotas for basic classes of
schedule I and II controlled substances
and ephedrine, pseudoephedrine, and
phenylpropanolamine by considering:
(1) Changes in demand for the basic
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 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 of the United States
and lawful export requirements, as the
Deputy Administrator finds relevant.
DEA also considered updated
information obtained from 2012 yearend inventories, 2012 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 and assessment of
annual needs had been established.
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
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Fmt 4703
Sfmt 4703
dosage form manufacturers, and other
pertinent information. In determining
the proposed revised 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).
As described in the previously
published notice establishing the 2013
aggregate production quotas and
assessment of annual needs, DEA has
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 has included
in all proposed revised schedule II
aggregate production quotas, and certain
schedule I aggregate production quotas,
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 revised 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 effects 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 for the three
temporarily scheduled substances be
established, and to adjust the 2013
aggregate production quotas for some
schedule I and II controlled substances
and ephedrine, pseudoephedrine, and
phenylpropanolamine, expressed in
grams of anhydrous acid or base, as
follows:
E:\FR\FM\20JNN1.SGM
20JNN1
37239
Federal Register / Vol. 78, No. 119 / Thursday, June 20, 2013 / Notices
Proposed or
proposed
adjusted
2013 quotas
Previously
established
2013 quotas
Basic class
Temporarily Scheduled Substances
(1-Pentyl-1H-indol-3-yl)(2,2,3,3-tetramethylcyclopropyl)methanone (UR–144) ....................................................
[1-(5-fluoro-pentyl)-1H-indol-3-yl](2,2,3,3-tetramethylcyclopropyl)methanone (XLR11) .......................................
N-(1-adamantyl)-1-pentyl-1H-indazole-3-carboxamide (AKB48) ..........................................................................
N/A
N/A
N/A
15 g.
15 g.
15 g.
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
12
30
35
24
35
25
2
2
12
12
88
12
12
25
68
53
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
g
g
g
g
g
g
g
g
g
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.
No change.
50 g.
No change.
No change.
No change.
No change.
No change.
No change.
No change.
No change.
25 g.
No change.
No change.
No change.
No change.
12
12
10
2
2
2
2
2
12
2
2
2
2
12
12
2
2
2
2
g
g
g
g
g
g
g
g
g
g
g
g
g
g
g
g
g
g
g
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
TKELLEY on DSK3SPTVN1PROD with NOTICES
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-[(4-methoxy)-benzoyl]indole (SR–19, RCS–4) ....................................................................................
1-Pentyl-3-[1-(4-methoxynaphthoyl)]indole (JWH–081) .......................................................................................
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) .........................................................................
3,4,5-Trimethoxyamphetamine .............................................................................................................................
3,4-Methylenedioxyamphetamine (MDA) .............................................................................................................
3,4-Methylenedioxymethamphetamine (MDMA) ..................................................................................................
3,4-Methylenedioxy-N-ethylamphetamine (MDEA) ..............................................................................................
3,4-Methylenedioxy-N-methylcathinone (methylone) ...........................................................................................
3,4-Methylenedioxypyrovalerone (MDPV) ............................................................................................................
3-Methylfentanyl ....................................................................................................................................................
3-Methylthiofentanyl ..............................................................................................................................................
4-Bromo-2,5-dimethoxyamphetamine (DOB) .......................................................................................................
4-Bromo-2,5-dimethoxyphenethylamine (2–CB) ..................................................................................................
4-Methoxyamphetamine .......................................................................................................................................
4-Methyl-2,5-dimethoxyamphetamine (DOM) .......................................................................................................
4-Methylaminorex .................................................................................................................................................
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 ............................................................................................................................................
VerDate Mar<15>2010
17:01 Jun 19, 2013
Jkt 229001
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E:\FR\FM\20JNN1.SGM
20JNN1
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change.
change.
37240
Federal Register / Vol. 78, No. 119 / Thursday, June 20, 2013 / Notices
Proposed or
proposed
adjusted
2013 quotas
Basic class
Previously
established
2013 quotas
Betameprodine ......................................................................................................................................................
Betamethadol ........................................................................................................................................................
Betaprodine ...........................................................................................................................................................
Bufotenine .............................................................................................................................................................
Cathinone ..............................................................................................................................................................
Codeine-N-oxide ...................................................................................................................................................
Desomorphine .......................................................................................................................................................
Diethyltryptamine ..................................................................................................................................................
Difenoxin ...............................................................................................................................................................
Dihydromorphine ...................................................................................................................................................
Dimethyltryptamine ...............................................................................................................................................
Gamma-hydroxybutyric acid .................................................................................................................................
Heroin ...................................................................................................................................................................
Hydromorphinol .....................................................................................................................................................
Hydroxypethidine ..................................................................................................................................................
Ibogaine ................................................................................................................................................................
Lysergic acid diethylamide (LSD) .........................................................................................................................
Marihuana .............................................................................................................................................................
Mescaline ..............................................................................................................................................................
Methaqualone .......................................................................................................................................................
Methcathinone ......................................................................................................................................................
Methyldihydromorphine .........................................................................................................................................
Morphine-N-oxide .................................................................................................................................................
N,N-Dimethylamphetamine ...................................................................................................................................
N-Benzylpiperazine ...............................................................................................................................................
N-Ethylamphetamine ............................................................................................................................................
N-Hydroxy-3,4-methylenedioxyamphetamine .......................................................................................................
Noracymethadol ....................................................................................................................................................
Norlevorphanol ......................................................................................................................................................
Normethadone ......................................................................................................................................................
Normorphine .........................................................................................................................................................
Para-fluorofentanyl ................................................................................................................................................
Phenomorphan .....................................................................................................................................................
Pholcodine ............................................................................................................................................................
Properidine ............................................................................................................................................................
Psilocybin ..............................................................................................................................................................
Psilocyn .................................................................................................................................................................
Tetrahydrocannabinols .........................................................................................................................................
Thiofentanyl ..........................................................................................................................................................
Tilidine ...................................................................................................................................................................
Trimeperidine ........................................................................................................................................................
2
2
2
3
12
602
5
12
50
3,300,000
18
46,250,000
25
54
2
5
30
21,000
13
10
14
2
655
12
15
12
12
2
52
2
18
2
2
2
2
2
4
491,000
2
10
2
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
g
g
g
g
g
g
g
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.
No change.
No change.
No change.
No change.
No change.
No change.
No change.
10 g.
No change.
No change.
No change.
No change.
No change.
3
21
2,250,000
38,250
3
9
22,875,000
42,625,000
6
240,000
81,250,000
49,506,250
19
250,000
750,000
127,500
3
2,108,750
3
99,625,000
5,968,750
5
4
6
4,500
21,000,000
6,875,000
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
No change.
No change.
No change.
No change.
No change.
No change.
No change.
47,186,000 g.
No change.
No change.
No change.
No change.
No change.
No change.
No change.
144,000 g.
No change.
No change.
No change.
No change.
No change.
No change.
No change.
No change.
No change.
No change.
No change.
TKELLEY on DSK3SPTVN1PROD with NOTICES
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 ............................................................................................................................................................
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Fmt 4703
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E:\FR\FM\20JNN1.SGM
20JNN1
37241
Federal Register / Vol. 78, No. 119 / Thursday, June 20, 2013 / Notices
Basic class
Meperidine Intermediate—A .................................................................................................................................
Meperidine Intermediate—B .................................................................................................................................
Meperidine Intermediate—C .................................................................................................................................
Metazocine ............................................................................................................................................................
Methadone (for sale) ............................................................................................................................................
Methadone Intermediate .......................................................................................................................................
Methamphetamine ................................................................................................................................................
6
11
6
6
25,000,000
32,500,000
3,912,500
Proposed or
proposed
adjusted
2013 quotas
Previously
established
2013 quotas
g
g
g
g
g
g
g
No change.
No change.
No change.
No change.
33,125,000 g.
40,500,000 g.
No change.
[987,500 grams of levo-desoxyephedrine for use in a non-controlled, non-prescription product; 2,863,750 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 ...............................................................................................................................................................
80,750,000
103,750,000
60,250,000
25,628
9,000,000
508,750
91,250
1,287,500
22,750,000
10,250,000
131,500,000
18,375,000
6,875,000
42,500,000
6
30
3
20,000,000
3
3,750
215,003
6,255
13,750,000
145,000,000
g
g
g
g
g
g
g
g
g
g
g
g
g
g
g
g
g
g
g
g
g
g
g
g
96,750,000 g.
91,250,000 g.
No change.
No change.
No change.
1,262,500 g.
No change.
No change.
No change.
No change.
153,750,000 g.
No change.
No change.
No change.
No change.
No change.
No change.
29,628,750 g.
No change.
No change.
No change.
No change.
No change.
No change.
15,100,000
3,500,000
25,700,000
6,100,000
225,000,000
g
g
g
g
g
No
No
No
No
No
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 remain 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
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
VerDate Mar<15>2010
17:01 Jun 19, 2013
Jkt 229001
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 any adjustment of
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: June 14, 2013.
Thomas M. Harrigan,
Deputy Administrator.
[FR Doc. 2013–14723 Filed 6–19–13; 8:45 am]
BILLING CODE 4410–09–P
PO 00000
Frm 00043
Fmt 4703
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change.
change.
change.
change.
change.
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
Manufacturer of Controlled
Substances; Notice of Application;
Noramco, Inc. (GA)
Pursuant to § 1301.33(a), Title 21 of
the Code of Federal Regulations (CFR),
this is notice that on March 21, 2012,
Noramco, Inc., 1440 Olympic Drive,
Athens, Georgia 30601, made
application to the Drug Enforcement
Administration (DEA) to be registered as
a bulk manufacturer of Opium tincture
(9630), a basic class of controlled
substance listed in schedule II.
The company plans to manufacture
the listed controlled substance in bulk
for distribution to its customers.
Any other such applicant, and any
person who is presently registered with
DEA to manufacture such substance,
E:\FR\FM\20JNN1.SGM
20JNN1
]]>Agencies
[Federal Register Volume 78, Number 119 (Thursday, June 20, 2013)]
[Notices]
[Pages 37237-37241]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-14723]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA-365]
Proposed Adjustments to the Aggregate Production Quotas for
Schedule I and II Controlled Substances and 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 to adjust the 2013 aggregate production
quotas for several 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,
as well as to establish the 2013 aggregate production quotas for three
recently temporarily scheduled substances.
DATES: Electronic comments must be submitted and written comments must
be postmarked on or before July 22, 2013. 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 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 https://www.regulations.gov for easy reference. Paper comments that duplicate
the electronic submission are not necessary and are strongly
discouraged as all comments submitted to 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: John W. Partridge, Executive
Assistant, Office of Diversion Control, Drug Enforcement
Administration, 8701 Morrissette Drive, Springfield, VA 22152;
Telephone: (202) 307-7165.
SUPPLEMENTARY INFORMATION:
Posting of Public Comments
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 through 28 CFR 0.100. The
Administrator, in turn, has redelegated this function to the Deputy
Administrator, pursuant to 28 CFR 0.104. DEA published the 2013
established aggregate production quotas for controlled substances in
schedules I and II and assessment of annual needs for the list I
chemicals ephedrine, pseudoephedrine, and phenylpropanolamine in the
Federal Register (77 FR 59980) on October 1, 2012. That notice
stipulated that, as provided for in 21 CFR 1303.13 and 21 CFR 1315.13,
all aggregate production quotas and assessments of annual need are
subject to adjustment.
Analysis for Proposed Aggregate Production Quotas for Temporarily
Scheduled Substances
On May 16, 2013, the Deputy Administrator issued a final order to
temporarily schedule three synthetic cannabinoids in schedule I of the
CSA: (1-Pentyl-1H-indol-3-yl)(2,2,3,3-tetramethylcyclopropyl)methanone
[[Page 37238]]
(UR-144); [1-(5-fluoro-pentyl)-1H-indol-3-yl](2,2,3,3-
tetramethylcyclopropyl)methanone (XLR11); and N-(1-adamantyl)-1-pentyl-
1H-indazole-3-carboxamide (AKB48). See 78 FR 28735. DEA has received
applications for registration and quota for these temporarily scheduled
substances. In examining the information provided by the applicants,
along with other information, DEA finds that there is a current need
for these substances. Aggregate production quotas represent those
quantities of schedule I and II controlled substances 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. As such, pursuant to 21 U.S.C. 826(a),
the Deputy Administrator must determine the total quantity and
establish production quotas for each of the three temporarily scheduled
substances.
In making this determination, the Deputy Administrator has taken
into account the criteria that DEA is required to consider in
accordance with 21 U.S.C. 826(a) and 21 CFR 1303.11. DEA proposes the
aggregate production quotas for these three temporarily scheduled
substances by considering: (1) Total estimated net disposal of each
substance by all manufacturers; (2) estimated trends in the national
rate of net disposal; (3) total estimated inventories of the basic
class and of all substances manufactured from the class; (4) projected
demand for each class as indicated by procurement quotas requested
pursuant to 21 CFR 1303.12; and (5) other factors affecting medical,
scientific, research, and industrial needs of the United States and
lawful export requirements, as the Deputy Administrator finds relevant.
These quotas do not include imports of controlled substances for use in
industrial processes.
Analysis for Proposed Revised 2013 Aggregate Production Quotas and
Assessment of Annual Needs
DEA proposes to adjust the established 2013 aggregate production
quotas for some schedule I and II controlled substances 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 do not include imports of
controlled substances for use in industrial processes. DEA is not
proposing to adjust the assessment of annual needs for the list I
chemicals ephedrine, pseudoephedrine, and phenylpropanolamine at this
time.
In proposing the adjustment, DEA has taken into account the
criteria that DEA is required to consider in accordance with 21 CFR
1303.13 and 21 CFR 1315.13. DEA determines whether to propose an
adjustment of the aggregate production quotas for basic classes of
schedule I and II controlled substances and ephedrine, pseudoephedrine,
and phenylpropanolamine by considering: (1) Changes in demand for the
basic 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 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 of the United
States and lawful export requirements, as the Deputy Administrator
finds relevant.
DEA also considered updated information obtained from 2012 year-end
inventories, 2012 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 and assessment of annual needs had
been established. 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 revised 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).
As described in the previously published notice establishing the
2013 aggregate production quotas and assessment of annual needs, DEA
has 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 has included in all
proposed revised schedule II aggregate production quotas, and certain
schedule I aggregate production quotas, 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 revised 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
effects 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 for the three temporarily scheduled
substances be established, and to adjust the 2013 aggregate production
quotas for some schedule I and II controlled substances and ephedrine,
pseudoephedrine, and phenylpropanolamine, expressed in grams of
anhydrous acid or base, as follows:
[[Page 37239]]
----------------------------------------------------------------------------------------------------------------
Previously
Basic class established Proposed or proposed adjusted 2013
2013 quotas quotas
----------------------------------------------------------------------------------------------------------------
Temporarily Scheduled Substances
----------------------------------------------------------------------------------------------------------------
(1-Pentyl-1H-indol-3-yl)(2,2,3,3- N/A 15 g.
tetramethylcyclopropyl)methanone (UR-144).
[1-(5-fluoro-pentyl)-1H-indol-3-yl](2,2,3,3- N/A 15 g.
tetramethylcyclopropyl)methanone (XLR11).
N-(1-adamantyl)-1-pentyl-1H-indazole-3-carboxamide N/A 15 g.
(AKB48).
----------------------------------------------------------------------------------------------------------------
Schedule I
----------------------------------------------------------------------------------------------------------------
1-(5-Fluoropentyl)-3-(1-naphthoyl)indole (AM2201)........ 45 g No change.
1-(5-Fluoropentyl)-3-(2-iodobenzoyl)indole (AM694)....... 45 g No change.
1-[1-(2-Thienyl)cyclohexyl]piperidine.................... 5 g No change.
1-[2-(4-Morpholinyl)ethyl]-3-(1-naphthoyl)indole (JWH- 45 g No change.
200).
1-Butyl-3-(1-naphthoyl)indole (JWH-073).................. 45 g No change.
1-Cyclohexylethyl-3-(2-methoxyphenylacetyl)indole (SR-18 45 g No change.
and RCS-8).
1-Hexyl-3-(1-naphthoyl)indole (JWH-019).................. 45 g No change.
1-Methyl-4-phenyl-4-propionoxypiperidine................. 2 g No change.
1-Pentyl-3-(1-naphthoyl)indole (JWH-018 and AM678)....... 45 g No change.
1-Pentyl-3-(2-chlorophenylacetyl)indole (JWH-203)........ 45 g No change.
1-Pentyl-3-(2-methoxyphenylacetyl)indole (JWH-250)....... 45 g No change.
1-Pentyl-3-(4-chloro-1-naphthoyl)indole (JWH-398)........ 45 g No change.
1-Pentyl-3-(4-methyl-1-naphthoyl)indole (JWH-122)........ 45 g No change.
1-Pentyl-3-[(4-methoxy)-benzoyl]indole (SR-19, RCS-4).... 45 g No change.
1-Pentyl-3-[1-(4-methoxynaphthoyl)]indole (JWH-081)...... 45 g No change.
2-(2,5-Dimethoxy-4-(n)-propylphenyl)ethanamine (2C-P).... 15 g No change.
2-(2,5-Dimethoxy-4-ethylphenyl)ethanamine (2C-E)......... 15 g No change.
2-(2,5-Dimethoxy-4-methylphenyl)ethanamine (2C-D)........ 15 g No change.
2-(2,5-Dimethoxy-4-nitro-phenyl)ethanamine (2C-N)........ 15 g No change.
2-(2,5-Dimethoxyphenyl)ethanamine (2C-H)................. 15 g No change.
2-(4-Chloro-2,5-dimethoxyphenyl)ethanamine (2C-C)........ 15 g No change.
2-(4-Iodo-2,5-dimethoxyphenyl)ethanamine (2C-I).......... 15 g No change.
2,5-Dimethoxy-4-ethylamphetamine (DOET).................. 12 g No change.
2,5-Dimethoxy-4-n-propylthiophenethylamine............... 12 g No change.
2,5-Dimethoxyamphetamine................................. 12 g No change.
2-[4-(Ethylthio)-2,5-dimethoxyphenyl]ethanamine (2C-T-2). 15 g No change.
2-[4-(Isopropylthio)-2,5-dimethoxyphenyl]ethanamine (2C-T- 15 g No change.
4).
3,4,5-Trimethoxyamphetamine.............................. 12 g No change.
3,4-Methylenedioxyamphetamine (MDA)...................... 30 g No change.
3,4-Methylenedioxymethamphetamine (MDMA)................. 35 g 50 g.
3,4-Methylenedioxy-N-ethylamphetamine (MDEA)............. 24 g No change.
3,4-Methylenedioxy-N-methylcathinone (methylone)......... 35 g No change.
3,4-Methylenedioxypyrovalerone (MDPV).................... 25 g No change.
3-Methylfentanyl......................................... 2 g No change.
3-Methylthiofentanyl..................................... 2 g No change.
4-Bromo-2,5-dimethoxyamphetamine (DOB)................... 12 g No change.
4-Bromo-2,5-dimethoxyphenethylamine (2-CB)............... 12 g No change.
4-Methoxyamphetamine..................................... 88 g No change.
4-Methyl-2,5-dimethoxyamphetamine (DOM).................. 12 g 25 g.
4-Methylaminorex......................................... 12 g No change.
4-Methyl-N-methylcathinone (mephedrone).................. 25 g No change.
5-(1,1-Dimethylheptyl)-2-[(1R,3S)-3-hydroxycyclohexyl]- 68 g No change.
phenol.
5-(1,1-Dimethyloctyl)-2-[(1R,3S)-3-hydroxycyclohexyl]- 53 g No change.
phenol (cannabicyclohexanol or CP-47, 497 C8-homolog).
5-Methoxy-3,4-methylenedioxyamphetamine.................. 12 g No change.
5-Methoxy-N,N-diisopropyltryptamine...................... 12 g No change.
5-Methoxy-N,N-dimethyltryptamine......................... 10 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.................................... 12 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)............................. 12 g No change.
Aminorex................................................. 12 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.
[[Page 37240]]
Betameprodine............................................ 2 g No change.
Betamethadol............................................. 2 g No change.
Betaprodine.............................................. 2 g No change.
Bufotenine............................................... 3 g No change.
Cathinone................................................ 12 g No change.
Codeine-N-oxide.......................................... 602 g No change.
Desomorphine............................................. 5 g No change.
Diethyltryptamine........................................ 12 g No change.
Difenoxin................................................ 50 g No change.
Dihydromorphine.......................................... 3,300,000 g No change.
Dimethyltryptamine....................................... 18 g No change.
Gamma-hydroxybutyric acid................................ 46,250,000 g No change.
Heroin................................................... 25 g No change.
Hydromorphinol........................................... 54 g No change.
Hydroxypethidine......................................... 2 g No change.
Ibogaine................................................. 5 g No change.
Lysergic acid diethylamide (LSD)......................... 30 g No change.
Marihuana................................................ 21,000 g No change.
Mescaline................................................ 13 g No change.
Methaqualone............................................. 10 g No change.
Methcathinone............................................ 14 g No change.
Methyldihydromorphine.................................... 2 g No change.
Morphine-N-oxide......................................... 655 g No change.
N,N-Dimethylamphetamine.................................. 12 g No change.
N-Benzylpiperazine....................................... 15 g No change.
N-Ethylamphetamine....................................... 12 g No change.
N-Hydroxy-3,4-methylenedioxyamphetamine.................. 12 g No change.
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.
Properidine.............................................. 2 g No change.
Psilocybin............................................... 2 g 10 g.
Psilocyn................................................. 4 g No change.
Tetrahydrocannabinols.................................... 491,000 g No change.
Thiofentanyl............................................. 2 g No change.
Tilidine................................................. 10 g No change.
Trimeperidine............................................ 2 g No change.
----------------------------------------------------------------------------------------------------------------
Schedule II
----------------------------------------------------------------------------------------------------------------
1-Phenylcyclohexylamine.................................. 3 g No change.
1-Piperdinocyclohexanecarbonitrile....................... 21 g No change.
4-Anilino-N-phenethyl-4-piperidine (ANPP)................ 2,250,000 g No change.
Alfentanil............................................... 38,250 g No change.
Alphaprodine............................................. 3 g No change.
Amobarbital.............................................. 9 g No change.
Amphetamine (for conversion)............................. 22,875,000 g No change.
Amphetamine (for sale)................................... 42,625,000 g 47,186,000 g.
Carfentanil.............................................. 6 g No change.
Cocaine.................................................. 240,000 g No change.
Codeine (for conversion)................................. 81,250,000 g No change.
Codeine (for sale)....................................... 49,506,250 g No change.
Dextropropoxyphene....................................... 19 g No change.
Dihydrocodeine........................................... 250,000 g No change.
Diphenoxylate............................................ 750,000 g No change.
Ecgonine................................................. 127,500 g 144,000 g.
Ethylmorphine............................................ 3 g No change.
Fentanyl................................................. 2,108,750 g No change.
Glutethimide............................................. 3 g No change.
Hydrocodone (for sale)................................... 99,625,000 g No change.
Hydromorphone............................................ 5,968,750 g No change.
Isomethadone............................................. 5 g No change.
Levo-alphacetylmethadol (LAAM)........................... 4 g No change.
Levomethorphan........................................... 6 g No change.
Levorphanol.............................................. 4,500 g No change.
Lisdexamfetamine......................................... 21,000,000 g No change.
Meperidine............................................... 6,875,000 g No change.
[[Page 37241]]
Meperidine Intermediate--A............................... 6 g No change.
Meperidine Intermediate--B............................... 11 g No change.
Meperidine Intermediate--C............................... 6 g No change.
Metazocine............................................... 6 g No change.
Methadone (for sale)..................................... 25,000,000 g 33,125,000 g.
Methadone Intermediate................................... 32,500,000 g 40,500,000 g.
Methamphetamine.......................................... 3,912,500 g No change.
----------------------------------------------------------------------------------------------------------------
[987,500 grams of levo-desoxyephedrine for use in a non-controlled, non-prescription product; 2,863,750 grams
for methamphetamine mostly for conversion to a schedule III product; and 61,250 grams for methamphetamine (for
sale)]
----------------------------------------------------------------------------------------------------------------
Methylphenidate.......................................... 80,750,000 g 96,750,000 g.
Morphine (for conversion)................................ 103,750,000 g 91,250,000 g.
Morphine (for sale)...................................... 60,250,000 g No change.
Nabilone................................................. 25,628 g No change.
Noroxymorphone (for conversion).......................... 9,000,000 g No change.
Noroxymorphone (for sale)................................ 508,750 g 1,262,500 g.
Opium (powder)........................................... 91,250 g No change.
Opium (tincture)......................................... 1,287,500 g No change.
Oripavine................................................ 22,750,000 g No change.
Oxycodone (for conversion)............................... 10,250,000 g No change.
Oxycodone (for sale)..................................... 131,500,000 g 153,750,000 g.
Oxymorphone (for conversion)............................. 18,375,000 g No change.
Oxymorphone (for sale)................................... 6,875,000 g No change.
Pentobarbital............................................ 42,500,000 g No change.
Phenazocine.............................................. 6 g No change.
Phencyclidine............................................ 30 g No change.
Phenmetrazine............................................ 3 g No change.
Phenylacetone............................................ 20,000,000 g 29,628,750 g.
Racemethorphan........................................... 3 g No change.
Remifentanil............................................. 3,750 g No change.
Secobarbital............................................. 215,003 g No change.
Sufentanil............................................... 6,255 g No change.
Tapentadol............................................... 13,750,000 g No change.
Thebaine................................................. 145,000,000 g No change.
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List I Chemicals
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Ephedrine (for conversion)............................... 15,100,000 g No change.
Ephedrine (for sale)..................................... 3,500,000 g No change.
Phenylpropanolamine (for conversion)..................... 25,700,000 g No change.
Phenylpropanolamine (for sale)........................... 6,100,000 g No change.
Pseudoephedrine (for sale)............................... 225,000,000 g No change.
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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 remain 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 any adjustment of 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: June 14, 2013.
Thomas M. Harrigan,
Deputy Administrator.
[FR Doc. 2013-14723 Filed 6-19-13; 8:45 am]
BILLING CODE 4410-09-P
