Final Adjusted 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 2014, 50700-50704 [2014-20137]
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50700
Federal Register / Vol. 79, No. 164 / Monday, August 25, 2014 / Notices
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA–378]
Final Adjusted 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 2014
Drug Enforcement
Administration (DEA), Department of
Justice (DOJ).
ACTION: Notice.
AGENCY:
This notice establishes the
final adjusted 2014 aggregate production
quotas for controlled substances in
schedules I and II of the Controlled
Substances Act (CSA) and the
assessment of annual needs for the List
I chemicals ephedrine,
pseudoephedrine, and
phenylpropanolamine, as well as the
2014 aggregate production quotas for
three recently temporarily controlled
substances.
DATES: Effective August 25, 2014.
FOR FURTHER INFORMATION CONTACT:
Imelda Paredes, Executive Assistant,
Office of Diversion Control, Drug
Enforcement Administration, 8701
Morrissette Drive, Springfield, VA
22152, Telephone: (202) 598–6812.
SUPPLEMENTARY INFORMATION:
emcdonald on DSK67QTVN1PROD with NOTICES
SUMMARY:
Background
Section 306 of the Controlled
Substances Act (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 Drug Enforcement
Administration (DEA) through 28 CFR
0.100(b). The Administrator, in turn, has
redelegated this function to the Deputy
Administrator, pursuant to 28 CFR pt. 0
subpt. R, App.
The DEA published the 2014
established aggregate production quotas
for controlled substances in schedules I
and II and for the assessment of annual
needs for the List I chemicals ephedrine,
pseudoephedrine, and
phenylpropanolamine in the Federal
Register (78 FR 55099) on September 9,
2013. That notice stated that the Deputy
Administrator would adjust, as needed,
the established aggregate production
quotas in 2014 in accordance with 21
CFR 1303.13 and 21 CFR 1315.13. The
2014 proposed adjusted aggregate
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production quotas for controlled
substances in schedules I and II and
assessment of annual needs for the List
I chemicals ephedrine,
pseudoephedrine, and
phenylpropanolamine were
subsequently published in the Federal
Register on June 12, 2014 (79 FR 33780)
in consideration of the outlined criteria.
All interested persons were invited to
comment on or object to the proposed
adjusted aggregate production quotas
and assessment of annual needs on or
before July 14, 2014.
Analysis for Final Adjusted 2014
Aggregate Production Quotas and
Assessment of Annual Needs
Consideration has been given to the
criteria outlined in the June 12, 2014,
notice of proposed adjusted aggregate
production quotas and assessment of
annual needs, in accordance with 21
CFR 1303.13 and 21 CFR 1315.13. Five
companies submitted timely comments
regarding a total of 11 schedule I and II
controlled substances. Comments
received proposed that the aggregate
production quotas for 4-anilinophenethyl-4-piperidine (ANPP), codeine
(for sale), diphenoxylate,
hydromorphone, levorphanol, morphine
(for conversion), oripavine, oxycodone
(for sale), oxymorphone (for
conversion), oxymorphone (for sale),
and tetrahydrocannabinols were
insufficient to provide for the estimated
medical, scientific, research, and
industrial needs of the United States, for
export requirements, and for the
establishment and maintenance of
reserve stocks. The DEA did not receive
any comments for the proposed
adjustments to the 2014 assessment of
annual needs for ephedrine,
pseudoephedrine, and
phenylpropanolamine.
The DEA has taken into consideration
the above comments along with the
relevant 2013 year-end inventories,
initial 2014 manufacturing and import
quotas, 2014 export requirements, actual
and projected 2014 sales, research and
product development requirements, and
the additional applications received.
Based on all of the above, the Deputy
Administrator has determined that the
proposed adjusted 2014 aggregate
production quotas and assessment of
annual needs for opium tincture,
oripavine, and ephedrine (for sale)
required additional consideration and
hereby further adjusts the 2014
aggregate production quota and
assessment of annual needs for these
substances. Regarding 4-anilinophenethyl-4-piperidine (ANPP), codeine
(for sale), diphenoxylate,
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hydromorphone, levorphanol, morphine
(for conversion), oxycodone (for sale),
oxymorphone (for conversion),
oxymorphone (for sale), and
tetrahydrocannabinols the Deputy
Administrator hereby determines that
the proposed adjusted 2014 aggregate
production quotas and assessment of
annual needs for these substances and
List I chemicals as published on June
12, 2014 (79 FR 33780) are sufficient to
meet the current 2014 estimated
medical, scientific, research, and
industrial needs of the United States
and to provide for adequate reserve
stock.
As described in the previously
published notice establishing the 2014
aggregate production quotas and
assessment of annual needs, the 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, the 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. The DEA
expects that maintaining this reserve in
certain established aggregate production
quotas will mitigate adverse public
effects if an unforeseen event results in
the substantial disruption to the amount
of controlled substances available to
provide for legitimate public need, as
determined by the DEA. The DEA does
not anticipate utilizing the reserve in
the absence of these circumstances.
Pursuant to the above, the Deputy
Administrator hereby finalizes the 2014
aggregate production quotas for the
following schedule I and II controlled
substances and the 2014 assessment of
annual needs for the List I chemicals
ephedrine, pseudoephedrine, and
phenylpropanolamine, expressed in
grams of anhydrous acid or base, as
follows:
E:\FR\FM\25AUN1.SGM
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Federal Register / Vol. 79, No. 164 / Monday, August 25, 2014 / Notices
50701
Final
adjusted
2014
quotas
(g)
Basic class
emcdonald on DSK67QTVN1PROD with NOTICES
Schedule I
(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) .....................................................................
1-(1,3-Benzodioxol-5-yl)-2-(methylamino)butan-1-one (butylone) .......................................................................................................
1-(1,3-Benzodioxol-5-yl)-2-(methylamino)pentan-1-one (pentylone) ...................................................................................................
1-(1-Phenylcyclohexyl)pyrrolidine ........................................................................................................................................................
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-Bromo-2,5-dimethoxyphenyl)-N-(2-methoxybenzyl)ethanamine (25B–NBOMe; 2C–B–NBOMe; 25B; Cimbi-36) ......................
2-(4-Chloro-2,5-dimethoxyphenyl)ethanamine (2C–C) ........................................................................................................................
2-(4-Chloro-2,5-dimethoxyphenyl)-N-(2-methoxybenzyl)ethanamine (25C–NBOMe; 2C–C–NBOMe; 25C; Cimbi-82) .....................
2-(4-Iodo-2,5-dimethoxyphenyl)ethanamine (2C–I) .............................................................................................................................
2-(4-Iodo-2,5-dimethoxyphenyl)-N-(2-methoxybenzyl)ethanamine (25I–NBOMe; 2C–I–NBOMe; 25I; Cimbi-5) ................................
2-(Methylamino)-1-phenylpentan-1-one (pentedrone) .........................................................................................................................
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-Fluoro-N-methylcathinone (3–FMC) .................................................................................................................................................
3-Methylfentanyl ...................................................................................................................................................................................
3-Methylthiofentanyl .............................................................................................................................................................................
4-Bromo-2,5-dimethoxyamphetamine (DOB) ......................................................................................................................................
4-Bromo-2,5-dimethoxyphenethylamine (2–CB) .................................................................................................................................
4-Fluoro-N-methylcathinone (4–FMC) .................................................................................................................................................
4-Methoxyamphetamine ......................................................................................................................................................................
4-Methyl-2,5-dimethoxyamphetamine (DOM) ......................................................................................................................................
4-Methylaminorex ................................................................................................................................................................................
4-Methyl-N-ethylcathinone (4–MEC) ...................................................................................................................................................
4-Methyl-N-methylcathinone (mephedrone) ........................................................................................................................................
4-Methyl-α-pyrrolidinopropiophenone (4-MePPP) ...............................................................................................................................
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 ............................................................................................................................................................................
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15
15
15
15
10
45
45
15
45
45
45
45
2
45
45
45
45
45
45
45
30
30
30
30
30
15
30
15
30
15
15
25
25
25
30
30
25
55
50
40
50
35
15
2
2
25
25
15
100
25
25
15
45
15
68
53
25
25
25
2
2
2
2
2
25
2
2
2
50702
Federal Register / Vol. 79, No. 164 / Monday, August 25, 2014 / Notices
Final
adjusted
2014
quotas
(g)
emcdonald on DSK67QTVN1PROD with NOTICES
Basic class
alpha-Methylthiofentanyl ......................................................................................................................................................................
alpha-Methyltryptamine (AMT) ............................................................................................................................................................
alpha-Pyrrolidinobutiophenone (a-PBP) ..............................................................................................................................................
alpha-Pyrrolidinopentiophenone (a-PVP) ............................................................................................................................................
Aminorex ..............................................................................................................................................................................................
Benzylmorphine ...................................................................................................................................................................................
Betacetylmethadol ...............................................................................................................................................................................
beta-Hydroxy-3-methylfentanyl ............................................................................................................................................................
beta-Hydroxyfentanyl ...........................................................................................................................................................................
Betameprodine .....................................................................................................................................................................................
Betaprodine ..........................................................................................................................................................................................
Bufotenine ............................................................................................................................................................................................
Cathinone .............................................................................................................................................................................................
Codeine methylbromide .......................................................................................................................................................................
Codeine-N-oxide ..................................................................................................................................................................................
Desomorphine ......................................................................................................................................................................................
Diethyltryptamine .................................................................................................................................................................................
Difenoxin ..............................................................................................................................................................................................
Dihydromorphine ..................................................................................................................................................................................
Dimethyltryptamine ..............................................................................................................................................................................
Dipipanone ...........................................................................................................................................................................................
Fenethylline ..........................................................................................................................................................................................
gamma-Hydroxybutyric acid ................................................................................................................................................................
Heroin ..................................................................................................................................................................................................
Hydromorphinol ....................................................................................................................................................................................
Hydroxypethidine .................................................................................................................................................................................
Ibogaine ...............................................................................................................................................................................................
Lysergic acid diethylamide (LSD) ........................................................................................................................................................
Marihuana ............................................................................................................................................................................................
Mescaline .............................................................................................................................................................................................
Methaqualone ......................................................................................................................................................................................
Methcathinone .....................................................................................................................................................................................
Methyldesorphine .................................................................................................................................................................................
Methyldihydromorphine ........................................................................................................................................................................
Morphine methylbromide .....................................................................................................................................................................
Morphine methylsulfonate ....................................................................................................................................................................
Morphine-N-oxide ................................................................................................................................................................................
N-(1-Adamantyl)-1-pentyl-1H-indazole-3-carboxamide (AKB48) ........................................................................................................
N-(1-Amino-3,3-dimethyl-1-oxobutan-2-yl)-1-pentyl-1H-indazole-3-carboxamide (ADB–PINACA) .....................................................
N-(1-Amino-3-methyl-1-oxobutan-2-yl)-1-(4-fluorobenzyl)-1H-indazole-3-carboxamide (AB–FUBINACA) .........................................
N,N-Dimethylamphetamine ..................................................................................................................................................................
Naphthylpyrovalerone (naphyrone) .....................................................................................................................................................
N-Benzylpiperazine ..............................................................................................................................................................................
N-Ethyl-1-phenylcyclohexylamine ........................................................................................................................................................
N-Ethylamphetamine ...........................................................................................................................................................................
N-Hydroxy-3,4-methylenedioxyamphetamine ......................................................................................................................................
Noracymethadol ...................................................................................................................................................................................
Norlevorphanol .....................................................................................................................................................................................
Normethadone .....................................................................................................................................................................................
Normorphine ........................................................................................................................................................................................
para-Fluorofentanyl ..............................................................................................................................................................................
Parahexyl .............................................................................................................................................................................................
Phenomorphan ....................................................................................................................................................................................
Pholcodine ...........................................................................................................................................................................................
Properidine ...........................................................................................................................................................................................
Psilocybin .............................................................................................................................................................................................
Psilocyn ................................................................................................................................................................................................
Quinolin-8-yl 1-(5-fluoropentyl)-1H-indole-3-carboxylate (5-fluoro-PB–22; 5F–PB–22) ......................................................................
Quinolin-8-yl 1-pentyl-1H-indole-3-carboxylate (PB–22; QUPIC) .......................................................................................................
Tetrahydrocannabinols ........................................................................................................................................................................
Thiofentanyl .........................................................................................................................................................................................
Tilidine ..................................................................................................................................................................................................
Trimeperidine .......................................................................................................................................................................................
2
25
15
15
25
2
2
2
2
2
2
3
70
5
200
5
25
50
3,990,000
35
5
5
70,250,000
25
2
2
5
35
650,000
25
10
25
2
2
5
5
175
15
15
15
25
15
25
5
24
24
2
52
2
18
2
5
2
2
2
40
50
15
15
491,000
2
10
2
Schedule II
1-Phenylcyclohexylamine ....................................................................................................................................................................
1-Piperidinocyclohexanecarbonitrile ....................................................................................................................................................
4-Anilino-N-phenethyl-4-piperidine (ANPP) .........................................................................................................................................
Alfentanil ..............................................................................................................................................................................................
Alphaprodine ........................................................................................................................................................................................
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25AUN1
3
3
2,687,500
17,625
3
Federal Register / Vol. 79, No. 164 / Monday, August 25, 2014 / Notices
50703
Final
adjusted
2014
quotas
(g)
Basic class
Amobarbital ..........................................................................................................................................................................................
Amphetamine (for conversion) ............................................................................................................................................................
Amphetamine (for sale) .......................................................................................................................................................................
Carfentanil ............................................................................................................................................................................................
Cocaine ................................................................................................................................................................................................
Codeine (for conversion) .....................................................................................................................................................................
Codeine (for sale) ................................................................................................................................................................................
Dextropropoxyphene ............................................................................................................................................................................
Dihydrocodeine ....................................................................................................................................................................................
Diphenoxylate ......................................................................................................................................................................................
Ecgonine ..............................................................................................................................................................................................
Ethylmorphine ......................................................................................................................................................................................
Fentanyl ...............................................................................................................................................................................................
Glutethimide .........................................................................................................................................................................................
Hydrocodone (for conversion) .............................................................................................................................................................
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 ...............................................................................................................................................................................
9
18,375,000
49,000,000
19
240,000
68,750,000
46,125,000
19
100,750
1,288,750
174,375
3
2,108,750
3
137,500
99,625,000
6,750,000
5
4
195
4,625
23,750,000
6,250,000
6
11
6
19
31,875,000
38,875,000
2,811,375
[1,250,000 grams of levo-desoxyephedrine for use in a non-controlled, non-prescription product; 1,500,000 grams for methamphetamine mostly
for conversion to a schedule III product; and 61,375 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 ..............................................................................................................................................................................................
96,750,000
91,250,000
62,500,000
30,375
17,500,000
1,262,500
112,500
780,000
30,625,000
9,250,000
149,375,000
25,000,000
7,750,000
35,000,000
6
19
3
45,750,000
3
5,875
215,003
6,255
17,500,000
145,000,000
emcdonald on DSK67QTVN1PROD with NOTICES
List I Chemicals
Ephedrine (for conversion) ..................................................................................................................................................................
Ephedrine (for sale) .............................................................................................................................................................................
Phenylpropanolamine (for conversion) ................................................................................................................................................
Phenylpropanolamine (for sale) ...........................................................................................................................................................
Pseudoephedrine (for conversion) ......................................................................................................................................................
Pseudoephedrine (for sale) .................................................................................................................................................................
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25AUN1
1,000,000
4,200,000
44,800,000
5,300,000
5,000
224,500,000
50704
Federal Register / Vol. 79, No. 164 / Monday, August 25, 2014 / Notices
Aggregate production quotas for all
other schedule I and II controlled
substances included in 21 CFR 1308.11
and 1308.12 remain at zero.
Dated: August 19, 2014.
Thomas G. Hohenthaner,
Acting VP/General Counsel and Corporate
Secretary, Millennium Challenge Corporation.
determination and selection for compact
negotiation (section 608(d) of the Act).
This report is the first of three
required reports listed above.
Dated: August 15, 2014.
Thomas M. Harrigan,
Deputy Administrator.
Report on Countries That Are
Candidates for Millennium Challenge
Account Eligibility for Fiscal Year 2015
and Countries That Would Be
Candidates but for Legal Prohibitions
Candidate Countries for FY 2015
The Act requires the identification of
all countries that are candidates for
MCA assistance for FY 2015 and the
identification of all countries that would
be candidate countries but for specified
legal prohibitions on assistance. Under
the terms of the Act, sections 606(a) and
(b) set forth the two income tests
countries must satisfy to be candidates
for MCA assistance.1 However for FY
2014, those categories are defined by
MCC’s FY 2014 appropriations act, the
Department of State, Foreign
Operations, and Related Programs
Appropriations Act, 2014, Public Law
113–76, Div. K (the FY 2014 SFOAA).
Specifically, the FY 2014 SFOAA used
the same definitions that have been
used since the FY 2012 appropriations
act and defines low income candidate
countries as the 75 poorest countries as
identified by the World Bank and
provided that a country that changes
during the fiscal year from low income
to lower middle income (or vice versa)
will retain its candidacy status in its
former income category for the fiscal
year and two subsequent fiscal years.
Assuming these definitions will be used
again in FY 2015, MCC is using them for
purposes of this report.2
Under the redefined categories, a
country will be a candidate for MCA
assistance for FY 2015 if it:
Meets one of the following tests:
Has a per capita income that is not
greater than the World Bank’s lower
middle income country threshold for
such fiscal year ($4,125 GNI per capita
for FY 2015); and is among the 75
[FR Doc. 2014–20137 Filed 8–22–14; 8:45 am]
BILLING CODE 4410–09–P
Summary
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA–392]
Importer of Controlled Substances
Application: CATALENT CTS, LLC;
Correction
ACTION:
Notice of correction.
In the Tuesday, June 17, 2014,
Federal Register document number
2014–14123, Vol. 79, No. 116, page
34551, third column, the second
paragraph, remove the first sentence
from the paragraph: ‘‘In reference to
drug code 7360, the company plans to
import a synthetic cannabidiol.’’
Dated: August 19, 2014.
Joseph T. Rannazzisi,
Deputy Assistant Administrator.
[FR Doc. 2014–20119 Filed 8–22–14; 8:45 am]
BILLING CODE 4410–09–P
MILLENNIUM CHALLENGE
CORPORATION
[MCC FR 14–05]
Report on Countries That Are
Candidates for Millennium Challenge
Account Eligibility in Fiscal Year 2015
and Countries That Would Be
Candidates But for Legal Prohibitions
Millennium Challenge
Corporation.
AGENCY:
ACTION:
Notice.
Section 608(d) of the
Millennium Challenge Act of 2003
requires the Millennium Challenge
Corporation to publish a report that
identifies countries that are ‘‘candidate
countries’’ for Millennium Challenge
Account assistance during FY 2015. The
report is set forth in full below.
emcdonald on DSK67QTVN1PROD with NOTICES
SUMMARY:
VerDate Mar<15>2010
17:31 Aug 22, 2014
Jkt 232001
This report to Congress is provided in
accordance with section 608(a) of the
Millennium Challenge Act of 2003, as
amended, 22 U.S.C. 7701, 7707(a) (the
Act).
The Act authorizes the provision of
Millennium Challenge Account (MCA)
assistance for countries that enter into a
Millennium Challenge Compact with
the United States to support policies
and programs that advance the progress
of such countries to achieve lasting
economic growth and poverty
reduction. The Act requires the
Millennium Challenge Corporation
(MCC) to take a number of steps in
selecting countries with which MCC
will seek to enter into a compact,
including determining the countries that
will be eligible for MCA assistance for
fiscal year (FY) 2015 based on (a) a
country’s demonstrated commitment to
(i) just and democratic governance, (ii)
economic freedom, and (iii) investments
in its people; and (b) considering the
opportunity to reduce poverty and
generate economic growth in the
country; and (c) the availability of funds
to MCC. These steps include the
submission of reports to the
congressional committees specified in
the Act and the publication of notices in
the Federal Register that identify:
The countries that are ‘‘candidate
countries’’ for MCA assistance for FY
2015 based on their per capita income
levels and their eligibility to receive
assistance under U.S. law and countries
that would be candidate countries but
for specified legal prohibitions on
assistance (section 608(a) of the Act);
The criteria and methodology that the
MCC Board of Directors (Board) will use
to measure and evaluate the relative
policy performance of the ‘‘candidate
countries’’ consistent with the
requirements of subsections (a) and (b)
of section 607 of the Act in order to
determine ‘‘eligible countries’’ from
among the ‘‘candidate countries’’
(section 608(b) of the Act); and
The list of countries determined by
the Board to be ‘‘eligible countries’’ for
FY 2015, identification of such
countries with which the Board will
seek to enter into compacts, and a
justification for such eligibility
PO 00000
Frm 00091
Fmt 4703
Sfmt 4703
1 Sections 606(a) and (b) of the Act provide that
a country will be a candidate for MCA assistance
if it (1) has a per capita income equal to or less than
the historical ceiling of the International
Development Association eligibility for the fiscal
year involved (the ‘‘low income category’’) or (2) is
classified as a lower middle income country in the
then most recent edition of the World Development
Report for Reconstruction and Development
published by the International Bank for
Reconstruction and Development and has an
income greater than the historical ceiling for
International Development Association eligibility
for the fiscal year involved (the ‘‘lower middle
income category’’); and is not ineligible to receive
U.S. economic assistance under part I of the Foreign
Assistance Act of 1961, as amended (the Foreign
Assistance Act), by reason of the application of the
Foreign Assistance Act or any other provision of
law.
2 If the language relating to the definition of low
income candidate countries is not enacted or is
changed for MCC’s FY 2015 appropriations act,
MCC will revisit the selection process once the FY
2015 appropriations act is enacted and will conduct
the selection process in accordance with the Act
and applicable provisions for FY 2015.
E:\FR\FM\25AUN1.SGM
25AUN1
]]>Agencies
[Federal Register Volume 79, Number 164 (Monday, August 25, 2014)]
[Notices]
[Pages 50700-50704]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-20137]
[[Page 50700]]
-----------------------------------------------------------------------
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA-378]
Final Adjusted 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 2014
AGENCY: Drug Enforcement Administration (DEA), Department of Justice
(DOJ).
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: This notice establishes the final adjusted 2014 aggregate
production quotas for controlled substances in schedules I and II of
the Controlled Substances Act (CSA) and the assessment of annual needs
for the List I chemicals ephedrine, pseudoephedrine, and
phenylpropanolamine, as well as the 2014 aggregate production quotas
for three recently temporarily controlled substances.
DATES: Effective August 25, 2014.
FOR FURTHER INFORMATION CONTACT: Imelda Paredes, Executive Assistant,
Office of Diversion Control, Drug Enforcement Administration, 8701
Morrissette Drive, Springfield, VA 22152, Telephone: (202) 598-6812.
SUPPLEMENTARY INFORMATION:
Background
Section 306 of the Controlled Substances Act (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 Drug
Enforcement Administration (DEA) through 28 CFR 0.100(b). The
Administrator, in turn, has redelegated this function to the Deputy
Administrator, pursuant to 28 CFR pt. 0 subpt. R, App.
The DEA published the 2014 established aggregate production quotas
for controlled substances in schedules I and II and for the assessment
of annual needs for the List I chemicals ephedrine, pseudoephedrine,
and phenylpropanolamine in the Federal Register (78 FR 55099) on
September 9, 2013. That notice stated that the Deputy Administrator
would adjust, as needed, the established aggregate production quotas in
2014 in accordance with 21 CFR 1303.13 and 21 CFR 1315.13. The 2014
proposed adjusted 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 were
subsequently published in the Federal Register on June 12, 2014 (79 FR
33780) in consideration of the outlined criteria. All interested
persons were invited to comment on or object to the proposed adjusted
aggregate production quotas and assessment of annual needs on or before
July 14, 2014.
Analysis for Final Adjusted 2014 Aggregate Production Quotas and
Assessment of Annual Needs
Consideration has been given to the criteria outlined in the June
12, 2014, notice of proposed adjusted aggregate production quotas and
assessment of annual needs, in accordance with 21 CFR 1303.13 and 21
CFR 1315.13. Five companies submitted timely comments regarding a total
of 11 schedule I and II controlled substances. Comments received
proposed that the aggregate production quotas for 4-anilino-phenethyl-
4-piperidine (ANPP), codeine (for sale), diphenoxylate, hydromorphone,
levorphanol, morphine (for conversion), oripavine, oxycodone (for
sale), oxymorphone (for conversion), oxymorphone (for sale), and
tetrahydrocannabinols were insufficient to provide for the estimated
medical, scientific, research, and industrial needs of the United
States, for export requirements, and for the establishment and
maintenance of reserve stocks. The DEA did not receive any comments for
the proposed adjustments to the 2014 assessment of annual needs for
ephedrine, pseudoephedrine, and phenylpropanolamine.
The DEA has taken into consideration the above comments along with
the relevant 2013 year-end inventories, initial 2014 manufacturing and
import quotas, 2014 export requirements, actual and projected 2014
sales, research and product development requirements, and the
additional applications received. Based on all of the above, the Deputy
Administrator has determined that the proposed adjusted 2014 aggregate
production quotas and assessment of annual needs for opium tincture,
oripavine, and ephedrine (for sale) required additional consideration
and hereby further adjusts the 2014 aggregate production quota and
assessment of annual needs for these substances. Regarding 4-anilino-
phenethyl-4-piperidine (ANPP), codeine (for sale), diphenoxylate,
hydromorphone, levorphanol, morphine (for conversion), oxycodone (for
sale), oxymorphone (for conversion), oxymorphone (for sale), and
tetrahydrocannabinols the Deputy Administrator hereby determines that
the proposed adjusted 2014 aggregate production quotas and assessment
of annual needs for these substances and List I chemicals as published
on June 12, 2014 (79 FR 33780) are sufficient to meet the current 2014
estimated medical, scientific, research, and industrial needs of the
United States and to provide for adequate reserve stock.
As described in the previously published notice establishing the
2014 aggregate production quotas and assessment of annual needs, the
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, the 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. The DEA expects that maintaining this reserve in certain
established aggregate production quotas will mitigate adverse public
effects if an unforeseen event results in the substantial disruption to
the amount of controlled substances available to provide for legitimate
public need, as determined by the DEA. The DEA does not anticipate
utilizing the reserve in the absence of these circumstances.
Pursuant to the above, the Deputy Administrator hereby finalizes
the 2014 aggregate production quotas for the following schedule I and
II controlled substances and the 2014 assessment of annual needs for
the List I chemicals ephedrine, pseudoephedrine, and
phenylpropanolamine, expressed in grams of anhydrous acid or base, as
follows:
[[Page 50701]]
------------------------------------------------------------------------
Final adjusted
Basic class 2014 quotas
(g)
------------------------------------------------------------------------
Schedule I
------------------------------------------------------------------------
(1-Pentyl-1H-indol-3-yl)(2,2,3,3- 15
tetramethylcyclopropyl)methanone (UR-144)..............
[1-(5-Fluoro-pentyl)-1H-indol-3-yl](2,2,3,3- 15
tetramethylcyclopropyl)methanone (XLR11)...............
1-(1,3-Benzodioxol-5-yl)-2-(methylamino)butan-1-one 15
(butylone).............................................
1-(1,3-Benzodioxol-5-yl)-2-(methylamino)pentan-1-one 15
(pentylone)............................................
1-(1-Phenylcyclohexyl)pyrrolidine....................... 10
1-(5-Fluoropentyl)-3-(1-naphthoyl)indole (AM2201)....... 45
1-(5-Fluoropentyl)-3-(2-iodobenzoyl)indole (AM694)...... 45
1-[1-(2-Thienyl)cyclohexyl]piperidine................... 15
1-[2-(4-Morpholinyl)ethyl]-3-(1-naphthoyl)indole (JWH- 45
200)...................................................
1-Butyl-3-(1-naphthoyl)indole (JWH-073)................. 45
1-Cyclohexylethyl-3-(2-methoxyphenylacetyl)indole (SR-18 45
and RCS-8).............................................
1-Hexyl-3-(1-naphthoyl)indole (JWH-019)................. 45
1-Methyl-4-phenyl-4-propionoxypiperidine................ 2
1-Pentyl-3-(1-naphthoyl)indole (JWH-018 and AM678)...... 45
1-Pentyl-3-(2-chlorophenylacetyl)indole (JWH-203)....... 45
1-Pentyl-3-(2-methoxyphenylacetyl)indole (JWH-250)...... 45
1-Pentyl-3-(4-chloro-1-naphthoyl)indole (JWH-398)....... 45
1-Pentyl-3-(4-methyl-1-naphthoyl)indole (JWH-122)....... 45
1-Pentyl-3-[(4-methoxy)-benzoyl]indole (SR-19, RCS-4)... 45
1-Pentyl-3-[1-(4-methoxynaphthoyl)]indole (JWH-081)..... 45
2-(2,5-Dimethoxy-4-n-propylphenyl)ethanamine (2C-P)..... 30
2-(2,5-Dimethoxy-4-ethylphenyl)ethanamine (2C-E)........ 30
2-(2,5-Dimethoxy-4-methylphenyl)ethanamine (2C-D)....... 30
2-(2,5-Dimethoxy-4-nitro-phenyl)ethanamine (2C-N)....... 30
2-(2,5-Dimethoxyphenyl)ethanamine (2C-H)................ 30
2-(4-Bromo-2,5-dimethoxyphenyl)-N-(2- 15
methoxybenzyl)ethanamine (25B-NBOMe; 2C-B-NBOMe; 25B;
Cimbi-36)..............................................
2-(4-Chloro-2,5-dimethoxyphenyl)ethanamine (2C-C)....... 30
2-(4-Chloro-2,5-dimethoxyphenyl)-N-(2- 15
methoxybenzyl)ethanamine (25C-NBOMe; 2C-C-NBOMe; 25C;
Cimbi-82)..............................................
2-(4-Iodo-2,5-dimethoxyphenyl)ethanamine (2C-I)......... 30
2-(4-Iodo-2,5-dimethoxyphenyl)-N-(2- 15
methoxybenzyl)ethanamine (25I-NBOMe; 2C-I-NBOMe; 25I;
Cimbi-5)...............................................
2-(Methylamino)-1-phenylpentan-1-one (pentedrone)....... 15
2,5-Dimethoxy-4-ethylamphetamine (DOET)................. 25
2,5-Dimethoxy-4-n-propylthiophenethylamine.............. 25
2,5-Dimethoxyamphetamine................................ 25
2-[4-(Ethylthio)-2,5-dimethoxyphenyl]ethanamine (2C-T-2) 30
2-[4-(Isopropylthio)-2,5-dimethoxyphenyl]ethanamine (2C- 30
T-4)...................................................
3,4,5-Trimethoxyamphetamine............................. 25
3,4-Methylenedioxyamphetamine (MDA)..................... 55
3,4-Methylenedioxymethamphetamine (MDMA)................ 50
3,4-Methylenedioxy-N-ethylamphetamine (MDEA)............ 40
3,4-Methylenedioxy-N-methylcathinone (methylone)........ 50
3,4-Methylenedioxypyrovalerone (MDPV)................... 35
3-Fluoro-N-methylcathinone (3-FMC)...................... 15
3-Methylfentanyl........................................ 2
3-Methylthiofentanyl.................................... 2
4-Bromo-2,5-dimethoxyamphetamine (DOB).................. 25
4-Bromo-2,5-dimethoxyphenethylamine (2-CB).............. 25
4-Fluoro-N-methylcathinone (4-FMC)...................... 15
4-Methoxyamphetamine.................................... 100
4-Methyl-2,5-dimethoxyamphetamine (DOM)................. 25
4-Methylaminorex........................................ 25
4-Methyl-N-ethylcathinone (4-MEC)....................... 15
4-Methyl-N-methylcathinone (mephedrone)................. 45
4-Methyl-[alpha]-pyrrolidinopropiophenone (4-MePPP)..... 15
5-(1,1-Dimethylheptyl)-2-[(1R,3S)-3-hydroxycyclohexyl]- 68
phenol.................................................
5-(1,1-Dimethyloctyl)-2-[(1R,3S)-3-hydroxycyclohexyl]- 53
phenol (cannabicyclohexanol or CP-47,497 C8-homolog)...
5-Methoxy-3,4-methylenedioxyamphetamine................. 25
5-Methoxy-N,N-diisopropyltryptamine..................... 25
5-Methoxy-N,N-dimethyltryptamine........................ 25
Acetyl-alpha-methylfentanyl............................. 2
Acetyldihydrocodeine.................................... 2
Acetylmethadol.......................................... 2
Allylprodine............................................ 2
Alphacetylmethadol...................................... 2
alpha-Ethyltryptamine................................... 25
Alphameprodine.......................................... 2
Alphamethadol........................................... 2
alpha-Methylfentanyl.................................... 2
[[Page 50702]]
alpha-Methylthiofentanyl................................ 2
alpha-Methyltryptamine (AMT)............................ 25
alpha-Pyrrolidinobutiophenone ([alpha]-PBP)............. 15
alpha-Pyrrolidinopentiophenone ([alpha]-PVP)............ 15
Aminorex................................................ 25
Benzylmorphine.......................................... 2
Betacetylmethadol....................................... 2
beta-Hydroxy-3-methylfentanyl........................... 2
beta-Hydroxyfentanyl.................................... 2
Betameprodine........................................... 2
Betaprodine............................................. 2
Bufotenine.............................................. 3
Cathinone............................................... 70
Codeine methylbromide................................... 5
Codeine-N-oxide......................................... 200
Desomorphine............................................ 5
Diethyltryptamine....................................... 25
Difenoxin............................................... 50
Dihydromorphine......................................... 3,990,000
Dimethyltryptamine...................................... 35
Dipipanone.............................................. 5
Fenethylline............................................ 5
gamma-Hydroxybutyric acid............................... 70,250,000
Heroin.................................................. 25
Hydromorphinol.......................................... 2
Hydroxypethidine........................................ 2
Ibogaine................................................ 5
Lysergic acid diethylamide (LSD)........................ 35
Marihuana............................................... 650,000
Mescaline............................................... 25
Methaqualone............................................ 10
Methcathinone........................................... 25
Methyldesorphine........................................ 2
Methyldihydromorphine................................... 2
Morphine methylbromide.................................. 5
Morphine methylsulfonate................................ 5
Morphine-N-oxide........................................ 175
N-(1-Adamantyl)-1-pentyl-1H-indazole-3-carboxamide 15
(AKB48)................................................
N-(1-Amino-3,3-dimethyl-1-oxobutan-2-yl)-1-pentyl-1H- 15
indazole-3-carboxamide (ADB-PINACA)....................
N-(1-Amino-3-methyl-1-oxobutan-2-yl)-1-(4-fluorobenzyl)- 15
1H-indazole-3-carboxamide (AB-FUBINACA)................
N,N-Dimethylamphetamine................................. 25
Naphthylpyrovalerone (naphyrone)........................ 15
N-Benzylpiperazine...................................... 25
N-Ethyl-1-phenylcyclohexylamine......................... 5
N-Ethylamphetamine...................................... 24
N-Hydroxy-3,4-methylenedioxyamphetamine................. 24
Noracymethadol.......................................... 2
Norlevorphanol.......................................... 52
Normethadone............................................ 2
Normorphine............................................. 18
para-Fluorofentanyl..................................... 2
Parahexyl............................................... 5
Phenomorphan............................................ 2
Pholcodine.............................................. 2
Properidine............................................. 2
Psilocybin.............................................. 40
Psilocyn................................................ 50
Quinolin-8-yl 1-(5-fluoropentyl)-1H-indole-3-carboxylate 15
(5-fluoro-PB-22; 5F-PB-22).............................
Quinolin-8-yl 1-pentyl-1H-indole-3-carboxylate (PB-22; 15
QUPIC).................................................
Tetrahydrocannabinols................................... 491,000
Thiofentanyl............................................ 2
Tilidine................................................ 10
Trimeperidine........................................... 2
------------------------------------------------------------------------
Schedule II
------------------------------------------------------------------------
1-Phenylcyclohexylamine................................. 3
1-Piperidinocyclohexanecarbonitrile..................... 3
4-Anilino-N-phenethyl-4-piperidine (ANPP)............... 2,687,500
Alfentanil.............................................. 17,625
Alphaprodine............................................ 3
[[Page 50703]]
Amobarbital............................................. 9
Amphetamine (for conversion)............................ 18,375,000
Amphetamine (for sale).................................. 49,000,000
Carfentanil............................................. 19
Cocaine................................................. 240,000
Codeine (for conversion)................................ 68,750,000
Codeine (for sale)...................................... 46,125,000
Dextropropoxyphene...................................... 19
Dihydrocodeine.......................................... 100,750
Diphenoxylate........................................... 1,288,750
Ecgonine................................................ 174,375
Ethylmorphine........................................... 3
Fentanyl................................................ 2,108,750
Glutethimide............................................ 3
Hydrocodone (for conversion)............................ 137,500
Hydrocodone (for sale).................................. 99,625,000
Hydromorphone........................................... 6,750,000
Isomethadone............................................ 5
Levo-alphacetylmethadol (LAAM).......................... 4
Levomethorphan.......................................... 195
Levorphanol............................................. 4,625
Lisdexamfetamine........................................ 23,750,000
Meperidine.............................................. 6,250,000
Meperidine Intermediate-A............................... 6
Meperidine Intermediate-B............................... 11
Meperidine Intermediate-C............................... 6
Metazocine.............................................. 19
Methadone (for sale).................................... 31,875,000
Methadone Intermediate.................................. 38,875,000
Methamphetamine......................................... 2,811,375
------------------------------------------------------------------------
[1,250,000 grams of levo-desoxyephedrine for use in a non-controlled,
non-prescription product; 1,500,000 grams for methamphetamine mostly
for conversion to a schedule III product; and 61,375 grams for
methamphetamine (for sale)]
------------------------------------------------------------------------
Methylphenidate......................................... 96,750,000
Morphine (for conversion)............................... 91,250,000
Morphine (for sale)..................................... 62,500,000
Nabilone................................................ 30,375
Noroxymorphone (for conversion)......................... 17,500,000
Noroxymorphone (for sale)............................... 1,262,500
Opium (powder).......................................... 112,500
Opium (tincture)........................................ 780,000
Oripavine............................................... 30,625,000
Oxycodone (for conversion).............................. 9,250,000
Oxycodone (for sale).................................... 149,375,000
Oxymorphone (for conversion)............................ 25,000,000
Oxymorphone (for sale).................................. 7,750,000
Pentobarbital........................................... 35,000,000
Phenazocine............................................. 6
Phencyclidine........................................... 19
Phenmetrazine........................................... 3
Phenylacetone........................................... 45,750,000
Racemethorphan.......................................... 3
Remifentanil............................................ 5,875
Secobarbital............................................ 215,003
Sufentanil.............................................. 6,255
Tapentadol.............................................. 17,500,000
Thebaine................................................ 145,000,000
------------------------------------------------------------------------
List I Chemicals
------------------------------------------------------------------------
Ephedrine (for conversion).............................. 1,000,000
Ephedrine (for sale).................................... 4,200,000
Phenylpropanolamine (for conversion).................... 44,800,000
Phenylpropanolamine (for sale).......................... 5,300,000
Pseudoephedrine (for conversion)........................ 5,000
Pseudoephedrine (for sale).............................. 224,500,000
------------------------------------------------------------------------
[[Page 50704]]
Aggregate production quotas for all other schedule I and II
controlled substances included in 21 CFR 1308.11 and 1308.12 remain at
zero.
Dated: August 15, 2014.
Thomas M. Harrigan,
Deputy Administrator.
[FR Doc. 2014-20137 Filed 8-22-14; 8:45 am]
BILLING CODE 4410-09-P
