[Federal Register Volume 79, Number 113 (Thursday, June 12, 2014)]
[Notices]
[Pages 33780-33784]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-13804]



[[Page 33780]]

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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. DEA-378]


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 2014

AGENCY: Drug Enforcement Administration (DEA), Department of Justice.

ACTION: Notice with request for comments.

-----------------------------------------------------------------------

SUMMARY: The Drug Enforcement Administration proposes to adjust the 
2014 aggregate production quotas for several controlled substances in 
schedules I and II of the Controlled Substances Act and assessment of 
annual needs for the list I chemicals ephedrine, pseudoephedrine, and 
phenylpropanolamine.

DATES: Interested persons may file written comments on this notice in 
accordance with 21 CFR 1303.11(c) and 1315.11(d). Electronic comments 
must be submitted, and written comments must be postmarked, on or 
before July 14, 2014. Commenters should be aware that the electronic 
Federal Docket Management System will not accept comments after 
midnight Eastern Time on the last day of the comment period.

ADDRESSES: To ensure proper handling of comments, please reference 
``Docket No. DEA-378'' on all electronic and written correspondence. 
The DEA encourages that all comments be submitted electronically 
through the Federal eRulemaking Portal at http://www.regulations.gov. 
Paper comments that duplicate electronic submissions are not necessary. 
Should you, however, wish to submit written comments via regular or 
express mail, they should be sent to: Drug Enforcement Administration, 
Attention: DEA Federal Register Representative/ODW, 8701 Morrissette 
Drive, Springfield, Virginia 22152.

FOR FURTHER INFORMATION CONTACT: Ruth A. Carter, Office of Diversion 
Control, Drug Enforcement Administration, 8701 Morrissette Drive, 
Springfield, Virginia 22152, Telephone: (202) 598-6812.

SUPPLEMENTARY INFORMATION:

Posting of Public Comments

    All comments received are considered part of the public record and 
will be made available for public inspection online at http://www.regulations.gov. Such information includes personal identifying 
information (such as your name, address, etc.) voluntarily submitted by 
the commenter.
    The Freedom of Information Act (FOIA) applies to all comments 
received. 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 made publicly available, 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 made publicly available 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 made publicly available, you 
must include the phrase ``CONFIDENTIAL BUSINESS INFORMATION'' in the 
first paragraph of your comment. You must also prominently identify the 
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 made 
publicly available. Comments containing personal identifying 
information or confidential business information identified as directed 
above will be made publicly available in redacted form.
    An electronic copy of this document is available at http://www.regulations.gov for easy reference. If you wish to personally 
inspect the comments and materials received or the supporting 
documentation the DEA used in preparing the proposed action, these 
materials will be available for public inspection by appointment. To 
arrange a viewing, please see the ``For Further Information Contact'' 
paragraph above.

Legal Authority

    Section 306 of the Controlled Substances Act (CSA), 21 U.S.C. 826, 
requires the Attorney General to determine the total quantity and 
establish aggregate production quotas for each basic class of 
controlled substance listed in schedules I and II and for the list I 
chemicals ephedrine, pseudoephedrine, and phenylpropanolamine. This 
responsibility has been delegated to the Administrator of the DEA 
pursuant to 28 CFR 0.100(b). The Administrator, in turn, has 
redelegated that authority to the Deputy Administrator, pursuant to 28 
CFR pt. 0 subpt. R, App.
    The DEA published the established aggregate production quotas for 
schedule I and II controlled substances and established assessment of 
annual needs for the list I chemicals ephedrine, pseudoephedrine, and 
phenylpropanolamine for 2014 in the Federal Register (78 FR 55099) on 
September 9, 2013. That notice stipulated that, in accordance with 21 
CFR 1303.13 and 1315.13, all aggregate production quotas and 
assessments of annual need are subject to adjustment.

Analysis for Proposed Adjusted 2014 Aggregate Production Quotas and 
Assessment of Annual Needs

    The DEA proposes to adjust the established 2014 aggregate 
production quotas for certain schedule I and II controlled substances 
to be manufactured in the United States in 2014 to provide for the 
estimated medical, scientific, research, and industrial needs of the 
United States, for lawful export requirements, and for the 
establishment and maintenance of reserve stocks. These quotas do not 
include imports of controlled substances for use in industrial 
processes. The DEA also proposes to adjust the established 2014 
assessment of annual needs for the list I chemicals ephedrine, 
pseudoephedrine, and phenylpropanolamine to be manufactured in and 
imported to the United States in 2014 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.
    In proposing the adjustment, the DEA has taken into account the 
criteria that the DEA is required to consider in accordance with 21 CFR 
1303.13 and 21 CFR 1315.13. The DEA determines whether to propose an 
adjustment of the aggregate production quotas for basic classes of 
schedule I and II controlled substances and assessment of annual needs 
for ephedrine, pseudoephedrine, and phenylpropanolamine by considering: 
(1) Changes in the demand for that class or chemical, changes in the 
national rate of net disposal of the class or chemical, and changes in 
the rate of net disposal of the class or chemical by registrants 
holding individual manufacturing quotas for the class; (2) whether any 
increased demand for that class or chemical, the national and/or 
individual rates of net disposal of that class or chemical are 
temporary, short term, or long term; (3) whether any increased demand 
for that class or chemical can be met through existing inventories, 
increased individual manufacturing quotas, or increased

[[Page 33781]]

importation, without increasing the aggregate production quota; (4) 
whether any decreased demand for that class or chemical will result in 
excessive inventory accumulation by all persons registered to handle 
that class or chemical; and (5) other factors affecting medical, 
scientific, research, and industrial needs in the United States and 
lawful export requirements, as the Deputy Administrator finds relevant.
    The DEA also considered updated information obtained from 2013 
year-end inventories, 2013 disposition data submitted by quota 
applicants, estimates of the medical needs of the United States, 
product development, and other information made available to the DEA 
after the initial aggregate production quotas and assessment of annual 
needs had been established. Other factors the 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 adjusted 2014 assessment of annual needs, the 
DEA used the calculation methodology previously described in the 2010 
and 2011 established assessment of annual needs (74 FR 60294, Nov. 20, 
2009, and 75 FR 79407, Dec. 20, 2010, respectively).
    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 adjusted schedule II controlled substance aggregate 
production quotas, and certain proposed adjusted schedule I controlled 
substance 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 adjusted established aggregate production quotas 
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 resulted in 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.
    The Deputy Administrator, therefore, proposes to adjust the 2014 
aggregate production quotas for certain schedule I and II controlled 
substances and assessment of annual needs for the list I chemicals 
ephedrine, pseudoephedrine, and phenylpropanolamine, expressed in grams 
of anhydrous acid or base, as follows:

------------------------------------------------------------------------
                                    Previously
                                    established   Proposed adjusted 2014
           Basic class              2014 quotas         quotas (g)
                                        (g)
------------------------------------------------------------------------
                               Schedule I
------------------------------------------------------------------------
(1-Pentyl-1H-indol-3-yl)(2,2,3,3-             15  No change.
 tetramethylcyclopropyl)methanon
 e (UR-144).
[1-(5-Fluoro-pentyl)-1H-indol-3-              15  No change.
 yl](2,2,3,3-
 tetramethylcyclopropyl)methanon
 e (XLR11).
1-(1,3-Benzodioxol-5-yl)-2-                   15  No change.
 (methylamino)butan-1-one
 (butylone).
1-(1,3-Benzodioxol-5-yl)-2-                   15  No change.
 (methylamino)pentan-1-one
 (pentylone).
1-(1-                                         10  No change.
 Phenylcyclohexyl)pyrrolidine.
1-(5-Fluoropentyl)-3-(1-                      45  No change.
 naphthoyl)indole (AM2201).
1-(5-Fluoropentyl)-3-(2-                      45  No change.
 iodobenzoyl)indole (AM694).
1-[1-(2-                                      15  No change.
 Thienyl)cyclohexyl]piperidine.
1-[2-(4-Morpholinyl)ethyl]-3-(1-              45  No change.
 naphthoyl)indole (JWH-200).
1-Butyl-3-(1-naphthoyl)indole                 45  No change.
 (JWH-073).
1-Cyclohexylethyl-3-(2-                       45  No change.
 methoxyphenylacetyl)indole (SR-
 18 and RCS-8).
1-Hexyl-3-(1-naphthoyl)indole                 45  No change.
 (JWH-019).
1-Methyl-4-phenyl-4-                           2  No change.
 propionoxypiperidine.
1-Pentyl-3-(1-naphthoyl)indole                45  No change.
 (JWH-018 and AM678).
1-Pentyl-3-(2-                                45  No change.
 chlorophenylacetyl)indole (JWH-
 203).
1-Pentyl-3-(2-                                45  No change.
 methoxyphenylacetyl)indole (JWH-
 250).
1-Pentyl-3-(4-chloro-1-                       45  No change.
 naphthoyl)indole (JWH-398).
1-Pentyl-3-(4-methyl-1-                       45  No change.
 naphthoyl)indole (JWH-122).
1-Pentyl-3-[(4-methoxy)-                      45  No change.
 benzoyl]indole (SR-19, RCS-4).
1-Pentyl-3-[1-(4-                             45  No change.
 methoxynaphthoyl)]indole (JWH-
 081).
2-(2,5-Dimethoxy-4-n-                         30  No change.
 propylphenyl)ethanamine (2C-P).
2-(2,5-Dimethoxy-4-                           30  No change.
 ethylphenyl)ethanamine (2C-E).
2-(2,5-Dimethoxy-4-                           30  No change.
 methylphenyl)ethanamine (2C-D).
2-(2,5-Dimethoxy-4-nitro-                     30  No change.
 phenyl)ethanamine (2C-N).
2-(2,5-                                       30  No change.
 Dimethoxyphenyl)ethanamine (2C-
 H).
2-(4-Bromo-2,5-dimethoxyphenyl)-              15  No change.
 N-(2-methoxybenzyl)ethanamine
 (25B-NBOMe; 2C-B-NBOMe; 25B;
 Cimbi-36).
2-(4-Chloro-2,5-                              30  No change.
 dimethoxyphenyl)ethanamine (2C-
 C).
2-(4-Chloro-2,5-dimethoxyphenyl)-             15  No change.
 N-(2-methoxybenzyl)ethanamine
 (25C-NBOMe; 2C-C-NBOMe; 25C;
 Cimbi-82).
2-(4-Iodo-2,5-                                30  No change.
 dimethoxyphenyl)ethanamine (2C-
 I).
2-(4-Iodo-2,5-dimethoxyphenyl)-N-             15  No change.
 (2-methoxybenzyl)ethanamine
 (25I-NBOMe; 2C-I-NBOMe; 25I;
 Cimbi-5).
2-(Methylamino)-1-phenylpentan-1-             15  No change.
 one (pentedrone).
2,5-Dimethoxy-4-ethylamphetamine              25  No change.
 (DOET).
2,5-Dimethoxy-4-n-                            25  No change.
 propylthiophenethylamine.

[[Page 33782]]

 
2,5-Dimethoxyamphetamine........              25  No change.
2-[4-(Ethylthio)-2,5-                         30  No change.
 dimethoxyphenyl]ethanamine (2C-
 T-2).
2-[4-(Isopropylthio)-2,5-                     30  No change.
 dimethoxyphenyl]ethanamine (2C-
 T-4).
3,4,5-Trimethoxyamphetamine.....              25  No change.
3,4-Methylenedioxyamphetamine                 55  No change.
 (MDA).
3,4-                                          50  No change.
 Methylenedioxymethamphetamine
 (MDMA).
3,4-Methylenedioxy-N-                         40  No change.
 ethylamphetamine (MDEA).
3,4-Methylenedioxy-N-                         50  No change.
 methylcathinone (methylone).
3,4-Methylenedioxypyrovalerone                35  No change.
 (MDPV).
3-Fluoro-N-methylcathinone (3-                15  No change.
 FMC).
3-Methylfentanyl................               2  No change.
3-Methylthiofentanyl............               2  No change.
4-Bromo-2,5-dimethoxyamphetamine              25  No change.
 (DOB).
4-Bromo-2,5-                                  25  No change.
 dimethoxyphenethylamine (2-CB).
4-Fluoro-N-methylcathinone (4-                15  No change.
 FMC).
4-Methoxyamphetamine............             100  No change.
4-Methyl-2,5-                                 25  No change.
 dimethoxyamphetamine (DOM).
4-Methylaminorex................              25  No change.
4-Methyl-N-ethylcathinone (4-                 15  No change.
 MEC).
4-Methyl-N-methylcathinone                    45  No change.
 (mephedrone).
4-Methyl-[alpha]-                             15  No change.
 pyrrolidinopropiophenone (4-
 MePPP).
5-(1,1-Dimethylheptyl)-2-                     68  No change.
 [(1R,3S)-3-hydroxycyclohexyl]-
 phenol.
5-(1,1-Dimethyloctyl)-2-[(1R,3S)-             53  No change.
 3-hydroxycyclohexyl]-phenol
 (cannabicyclohexanol or CP-
 47,497 C8-homolog).
5-Methoxy-3,4-                                25  No change.
 methylenedioxyamphetamine.
5-Methoxy-N,N-                                25  No change.
 diisopropyltryptamine.
5-Methoxy-N,N-dimethyltryptamine              25  No change.
Acetyl-alpha-methylfentanyl.....               2  No change.
Acetyldihydrocodeine............               2  No change.
Acetylmethadol..................               2  No change.
Allylprodine....................               2  No change.
Alphacetylmethadol..............               2  No change.
alpha-Ethyltryptamine...........              25  No change.
Alphameprodine..................               2  No change.
Alphamethadol...................               2  No change.
alpha-Methylfentanyl............               2  No change.
alpha-Methylthiofentanyl........               2  No change.
alpha-Methyltryptamine (AMT)....              25  No change.
alpha-Pyrrolidinobutiophenone                 15  No change.
 ([alpha]-PBP).
alpha-Pyrrolidinopentiophenone                15  No change.
 ([alpha]-PVP).
Aminorex........................              25  No change.
Benzylmorphine..................               2  No change.
Betacetylmethadol...............               2  No change.
beta-Hydroxy-3-methylfentanyl...               2  No change.
beta-Hydroxyfentanyl............               2  No change.
Betameprodine...................               2  No change.
Betaprodine.....................               2  No change.
Bufotenine......................               3  No change.
Cathinone.......................              70  No change.
Codeine methylbromide...........               5  No change.
Codeine-N-oxide.................             200  No change.
Desomorphine....................               5  No change.
Diethyltryptamine...............              25  No change.
Difenoxin.......................              50  No change.
Dihydromorphine.................       3,990,000  No change.
Dimethyltryptamine..............              35  No change.
Dipipanone......................               5  No change.
Fenethylline....................               5  No change.
gamma-Hydroxybutyric acid.......      70,250,000  No change.
Heroin..........................              25  No change.
Hydromorphinol..................               2  No change.
Hydroxypethidine................               2  No change.
Ibogaine........................               5  No change.
Lysergic acid diethylamide (LSD)              35  No change.
Marihuana.......................         650,000  No change.
Mescaline.......................              25  No change.
Methaqualone....................              10  No change.
Methcathinone...................              25  No change.
Methyldesorphine................               2  No change.
Methyldihydromorphine...........               2  No change.
Morphine methylbromide..........               5  No change.

[[Page 33783]]

 
Morphine methylsulfonate........               5  No change.
Morphine-N-oxide................             175  No change.
N-(1-Adamantyl)-1-pentyl-1H-                  15  No change.
 indazole-3-carboxamide (AKB48).
N-(1-Amino-3,3-dimethyl-1-                    15  No change.
 oxobutan-2-yl)-1-pentyl-1H-
 indazole-3-carboxamide (ADB-
 PINACA).
N-(1-Amino-3-methyl-1-oxobutan-2-             15  No change.
 yl)-1-(4-fluorobenzyl)-1H-
 indazole-3-carboxamide (AB-
 FUBINACA).
N,N-Dimethylamphetamine.........              25  No change.
Naphthylpyrovalerone (naphyrone)              15  No change.
N-Benzylpiperazine..............              25  No change.
N-Ethyl-1-phenylcyclohexylamine.               5  No change.
N-Ethylamphetamine..............              24  No change.
N-Hydroxy-3,4-                                24  No change.
 methylenedioxyamphetamine.
Noracymethadol..................               2  No change.
Norlevorphanol..................              52  No change.
Normethadone....................               2  No change.
Normorphine.....................              18  No change.
para-Fluorofentanyl.............               2  No change.
Parahexyl.......................               5  No change.
Phenomorphan....................               2  No change.
Pholcodine......................               2  No change.
Properidine.....................               2  No change.
Psilocybin......................              30  40
Psilocyn........................              30  50
Quinolin-8-yl 1-(5-fluoropentyl)-             15  No change.
 1H-indole-3-carboxylate (5-
 fluoro-PB-22; 5F-PB-22).
Quinolin-8-yl 1-pentyl-1H-indole-             15  No change.
 3-carboxylate (PB-22; QUPIC).
Tetrahydrocannabinols...........         491,000  No change.
Thiofentanyl....................               2  No change.
Tilidine........................              10  No change.
Trimeperidine...................               2  No change.
------------------------------------------------------------------------
                               Schedule II
------------------------------------------------------------------------
1-Phenylcyclohexylamine.........               3  No change.
1-                                             3  No change.
 Piperidinocyclohexanecarbonitri
 le.
4-Anilino-N-phenethyl-4-               2,687,500  No change.
 piperidine (ANPP).
Alfentanil......................          17,625  No change.
Alphaprodine....................               3  No change.
Amobarbital.....................               9  No change.
Amphetamine (for conversion)....      18,375,000  No change.
Amphetamine (for sale)..........      49,000,000  No change.
Carfentanil.....................              19  No change.
Cocaine.........................         240,000  No change.
Codeine (for conversion)........      68,750,000  No change.
Codeine (for sale)..............      46,125,000  No change.
Dextropropoxyphene..............              19  No change.
Dihydrocodeine..................         100,750  No change.
Diphenoxylate...................         750,000  1,288,750
Ecgonine........................         144,000  174,375
Ethylmorphine...................               3  No change.
Fentanyl........................       2,108,750  No change.
Glutethimide....................               3  No change.
Hydrocodone (for conversion)....               0  137,500
Hydrocodone (for sale)..........      99,625,000  No change.
Hydromorphone...................       6,750,000  No change.
Isomethadone....................               5  No change.
Levo-alphacetylmethadol (LAAM)..               4  No change.
Levomethorphan..................             195  No change.
Levorphanol.....................           2,000  4,625
Lisdexamfetamine................      23,750,000  No change.
Meperidine......................       6,250,000  No change.
Meperidine Intermediate-A.......               6  No change.
Meperidine Intermediate-B.......              11  No change.
Meperidine Intermediate-C.......               6  No change.
Metazocine......................              19  No change.
Methadone (for sale)............      31,875,000  No change.
Methadone Intermediate..........      38,875,000  No change.
Methamphetamine.................       2,811,375  No change.
------------------------------------------------------------------------
[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  No change.
Morphine (for conversion).......      91,250,000  No change.

[[Page 33784]]

 
Morphine (for sale).............      62,500,000  No change.
Nabilone........................          30,375  No change.
Noroxymorphone (for conversion).      17,500,000  No change.
Noroxymorphone (for sale).......       1,262,500  No change.
Opium (powder)..................         112,500  No change.
Opium (tincture)................         625,000  No change.
Oripavine.......................      22,750,000  27,625,000
Oxycodone (for conversion)......       9,250,000  No change.
Oxycodone (for sale)............     149,375,000  No change.
Oxymorphone (for conversion)....      25,000,000  No change.
Oxymorphone (for sale)..........       7,750,000  No change.
Pentobarbital...................      35,000,000  No change.
Phenazocine.....................               6  No change.
Phencyclidine...................              19  No change.
Phenmetrazine...................               3  No change.
Phenylacetone...................      67,000,000  45,750,000
Racemethorphan..................               3  No change.
Remifentanil....................           3,750  5,875
Secobarbital....................         215,003  No change.
Sufentanil......................           6,255  No change.
Tapentadol......................      17,500,000  No change.
Thebaine........................     145,000,000  No change.
------------------------------------------------------------------------
                            List I Chemicals
------------------------------------------------------------------------
Ephedrine (for conversion)......       1,000,000  No change.
Ephedrine (for sale)............       3,000,000  No change.
Phenylpropanolamine (for              44,800,000  No change.
 conversion).
Phenylpropanolamine (for sale)..       5,300,000  No change.
Pseudoephedrine (for conversion)           5,000  No change.
Pseudoephedrine (for sale)......     192,000,000  224,500,000
------------------------------------------------------------------------

    The Deputy Administrator further proposes that aggregate production 
quotas for all other schedule I and II controlled substances included 
in 21 CFR 1308.11 and 1308.12 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 2014 aggregate production 
quotas and assessment of annual needs as needed.

Comments

    Pursuant to 21 CFR 1303.11(c) and 1315.11(d), 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. 21 CFR 1303.11(c) and 1515.11(e). In the event the 
Deputy Administrator decides to hold such a hearing, the Deputy 
Administrator will publish a notice of the hearing in the Federal 
Register. After consideration of any comments or objections, or after a 
hearing, if one is held, the Deputy Administrator will issue and 
publish in the Federal Register a final order establishing any 
adjustment of 2014 aggregate production quota for each basic class of 
controlled substance and established assessment of annual needs for the 
list I chemicals ephedrine, pseudoephedrine, and phenylpropanolamine. 
21 CFR 1303.11(c) and 1315.11(f).

    Dated: June 4, 2014.
Thomas M. Harrigan,
Deputy Administrator.
[FR Doc. 2014-13804 Filed 6-11-14; 8:45 am]
BILLING CODE 4410-09-P