[Federal Register Volume 78, Number 119 (Thursday, June 20, 2013)]
[Notices]
[Pages 37237-37241]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-14723]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. DEA-365]


Proposed Adjustments to the Aggregate Production Quotas for 
Schedule I and II Controlled Substances and Assessment of Annual Needs 
for the List I Chemicals Ephedrine, Pseudoephedrine, and 
Phenylpropanolamine for 2013

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

ACTION: Notice with request for comments.

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SUMMARY: This notice proposes to adjust the 2013 aggregate production 
quotas for several controlled substances in schedules I and II of the 
Controlled Substances Act (CSA) and assessment of annual needs for the 
list I chemicals ephedrine, pseudoephedrine, and phenylpropanolamine, 
as well as to establish the 2013 aggregate production quotas for three 
recently temporarily scheduled substances.

DATES: Electronic comments must be submitted and written comments must 
be postmarked on or before July 22, 2013. The electronic Federal Docket 
Management System will not accept comments after midnight Eastern Time 
on the last day of the comment period.

ADDRESSES: To ensure proper handling of comments, please reference 
``Docket No. DEA-365'' on all electronic and written correspondence. 
DEA encourages all comments be submitted electronically through http://www.regulations.gov using the electronic comment form provided on that 
site. An electronic copy of this document is also available at http://www.regulations.gov for easy reference. Paper comments that duplicate 
the electronic submission are not necessary and are strongly 
discouraged as all comments submitted to www.regulations.gov will be 
posted for public review and are part of the official docket record. 
Should you, however, wish to submit written comments via regular or 
express mail, they should be sent to the Drug Enforcement 
Administration, Attention: DEA Federal Register Representative/ODL, 
8701 Morrissette Drive, Springfield, VA 22152.

FOR FURTHER INFORMATION CONTACT: John W. Partridge, Executive 
Assistant, Office of Diversion Control, Drug Enforcement 
Administration, 8701 Morrissette Drive, Springfield, VA 22152; 
Telephone: (202) 307-7165.

SUPPLEMENTARY INFORMATION:

Posting of Public Comments

    All comments received are considered part of the public record and 
made available for public inspection online at http://www.regulations.gov and in the DEA's public docket. Such information 
includes personal identifying information (such as your name, address, 
etc.) voluntarily submitted by the commenter.
    If you want to submit personal identifying information (such as 
your name, address, etc.) as part of your comment, but do not want it 
to be posted online or made available in the public docket, you must 
include the phrase ``PERSONAL IDENTIFYING INFORMATION'' in the first 
paragraph of your comment. You must also place all the personal 
identifying information you do not want posted online or made available 
in the public docket in the first paragraph of your comment and 
identify what information you want redacted.
    If you want to submit confidential business information as part of 
your comment, but do not want it to be posted online or made available 
in the public docket, you must include the phrase ``CONFIDENTIAL 
BUSINESS INFORMATION'' in the first paragraph of your comment. You must 
also prominently identify confidential business information to be 
redacted within the comment. If a comment has so much confidential 
business information that it cannot be effectively redacted, all or 
part of that comment may not be posted online or made available in the 
public docket.
    Personal identifying information and confidential business 
information identified and located as set forth above will be redacted, 
and the comment, in redacted form, will be posted online and placed in 
the DEA's public docket file. Please note that the Freedom of 
Information Act applies to all comments received. If you wish to 
inspect the agency's public docket file in person by appointment, 
please see the For Further Information Contact paragraph.

Background

    Section 306 of the CSA (21 U.S.C. 826) requires the Attorney 
General to establish aggregate production quotas for each basic class 
of controlled substance listed in schedules I and II and for ephedrine, 
pseudoephedrine, and phenylpropanolamine. This responsibility has been 
delegated to the Administrator of the DEA through 28 CFR 0.100. The 
Administrator, in turn, has redelegated this function to the Deputy 
Administrator, pursuant to 28 CFR 0.104. DEA published the 2013 
established aggregate production quotas for controlled substances in 
schedules I and II and assessment of annual needs for the list I 
chemicals ephedrine, pseudoephedrine, and phenylpropanolamine in the 
Federal Register (77 FR 59980) on October 1, 2012. That notice 
stipulated that, as provided for in 21 CFR 1303.13 and 21 CFR 1315.13, 
all aggregate production quotas and assessments of annual need are 
subject to adjustment.

Analysis for Proposed Aggregate Production Quotas for Temporarily 
Scheduled Substances

    On May 16, 2013, the Deputy Administrator issued a final order to 
temporarily schedule three synthetic cannabinoids in schedule I of the 
CSA: (1-Pentyl-1H-indol-3-yl)(2,2,3,3-tetramethylcyclopropyl)methanone

[[Page 37238]]

(UR-144); [1-(5-fluoro-pentyl)-1H-indol-3-yl](2,2,3,3-
tetramethylcyclopropyl)methanone (XLR11); and N-(1-adamantyl)-1-pentyl-
1H-indazole-3-carboxamide (AKB48). See 78 FR 28735. DEA has received 
applications for registration and quota for these temporarily scheduled 
substances. In examining the information provided by the applicants, 
along with other information, DEA finds that there is a current need 
for these substances. Aggregate production quotas represent those 
quantities of schedule I and II controlled substances to be 
manufactured in the United States in 2013 to provide for the estimated 
medical, scientific, research, and industrial needs of the United 
States, lawful export requirements, and the establishment and 
maintenance of reserve stocks. As such, pursuant to 21 U.S.C. 826(a), 
the Deputy Administrator must determine the total quantity and 
establish production quotas for each of the three temporarily scheduled 
substances.
    In making this determination, the Deputy Administrator has taken 
into account the criteria that DEA is required to consider in 
accordance with 21 U.S.C. 826(a) and 21 CFR 1303.11. DEA proposes the 
aggregate production quotas for these three temporarily scheduled 
substances by considering: (1) Total estimated net disposal of each 
substance by all manufacturers; (2) estimated trends in the national 
rate of net disposal; (3) total estimated inventories of the basic 
class and of all substances manufactured from the class; (4) projected 
demand for each class as indicated by procurement quotas requested 
pursuant to 21 CFR 1303.12; and (5) other factors affecting medical, 
scientific, research, and industrial needs of the United States and 
lawful export requirements, as the Deputy Administrator finds relevant. 
These quotas do not include imports of controlled substances for use in 
industrial processes.

Analysis for Proposed Revised 2013 Aggregate Production Quotas and 
Assessment of Annual Needs

    DEA proposes to adjust the established 2013 aggregate production 
quotas for some schedule I and II controlled substances to be 
manufactured in the United States in 2013 to provide for the estimated 
medical, scientific, research, and industrial needs of the United 
States, lawful export requirements, and the establishment and 
maintenance of reserve stocks. These quotas do not include imports of 
controlled substances for use in industrial processes. DEA is not 
proposing to adjust the assessment of annual needs for the list I 
chemicals ephedrine, pseudoephedrine, and phenylpropanolamine at this 
time.
    In proposing the adjustment, DEA has taken into account the 
criteria that DEA is required to consider in accordance with 21 CFR 
1303.13 and 21 CFR 1315.13. DEA determines whether to propose an 
adjustment of the aggregate production quotas for basic classes of 
schedule I and II controlled substances and ephedrine, pseudoephedrine, 
and phenylpropanolamine by considering: (1) Changes in demand for the 
basic class, changes in the national rate of net disposal for the 
class, and changes in the rate of net disposal by the registrants 
holding individual manufacturing quotas for the class; (2) whether any 
increased demand or changes in the national or individual rates of net 
disposal are temporary, short term, or long term; (3) whether any 
increased demand can be met through existing inventories, increased 
individual manufacturing quotas, or increased importation, without 
increasing the aggregate production quota; (4) whether any decreased 
demand will result in excessive inventory accumulation by all persons 
registered to handle the class; and (5) other factors affecting the 
medical, scientific, research, and industrial needs of the United 
States and lawful export requirements, as the Deputy Administrator 
finds relevant.
    DEA also considered updated information obtained from 2012 year-end 
inventories, 2012 disposition data submitted by quota applicants, 
estimates of the medical needs of the United States, product 
development, and other information made available to DEA after the 
initial aggregate production quotas and assessment of annual needs had 
been established. Other factors DEA considered in calculating the 
aggregate production quotas, but not the assessment of annual needs, 
include product development requirements of both bulk and finished 
dosage form manufacturers, and other pertinent information. In 
determining the proposed revised 2013 assessment of annual needs, DEA 
used the calculation methodology previously described in the 2010 and 
2011 assessment of annual needs (74 FR 60294 and 75 FR 79407, 
respectively).
    As described in the previously published notice establishing the 
2013 aggregate production quotas and assessment of annual needs, DEA 
has specifically considered that inventory allowances granted to 
individual manufacturers may not always result in the availability of 
sufficient quantities to maintain an adequate reserve stock pursuant to 
21 U.S.C. 826(a), as intended. See 21 CFR 1303.24. This would be 
concerning if a natural disaster or other unforeseen event resulted in 
substantial disruption to the amount of controlled substances available 
to provide for legitimate public need. As such, DEA has included in all 
proposed revised schedule II aggregate production quotas, and certain 
schedule I aggregate production quotas, an additional 25% of the 
estimated medical, scientific, and research needs as part of the amount 
necessary to ensure the establishment and maintenance of reserve 
stocks. The resulting revised established aggregate production quota 
will reflect these included amounts. This action will not affect the 
ability of manufacturers to maintain inventory allowances as specified 
by regulation. DEA expects that maintaining this reserve in certain 
established aggregate production quotas will mitigate adverse public 
effects if an unforeseen event resulted in substantial disruption to 
the amount of controlled substances available to provide for legitimate 
public need, as determined by DEA. DEA does not anticipate utilizing 
the reserve in the absence of these circumstances.
    The Deputy Administrator, therefore, proposes that the year 2013 
aggregate production quotas for the three temporarily scheduled 
substances be established, and to adjust the 2013 aggregate production 
quotas for some schedule I and II controlled substances and ephedrine, 
pseudoephedrine, and phenylpropanolamine, expressed in grams of 
anhydrous acid or base, as follows:

[[Page 37239]]



----------------------------------------------------------------------------------------------------------------
                                                             Previously
                       Basic class                           established    Proposed or proposed  adjusted  2013
                                                             2013 quotas                   quotas
----------------------------------------------------------------------------------------------------------------
                                        Temporarily Scheduled Substances
----------------------------------------------------------------------------------------------------------------
(1-Pentyl-1H-indol-3-yl)(2,2,3,3-                                     N/A  15 g.
 tetramethylcyclopropyl)methanone (UR-144).
[1-(5-fluoro-pentyl)-1H-indol-3-yl](2,2,3,3-                          N/A  15 g.
 tetramethylcyclopropyl)methanone (XLR11).
N-(1-adamantyl)-1-pentyl-1H-indazole-3-carboxamide                    N/A  15 g.
 (AKB48).
----------------------------------------------------------------------------------------------------------------
                                                   Schedule I
----------------------------------------------------------------------------------------------------------------
1-(5-Fluoropentyl)-3-(1-naphthoyl)indole (AM2201)........            45 g  No change.
1-(5-Fluoropentyl)-3-(2-iodobenzoyl)indole (AM694).......            45 g  No change.
1-[1-(2-Thienyl)cyclohexyl]piperidine....................             5 g  No change.
1-[2-(4-Morpholinyl)ethyl]-3-(1-naphthoyl)indole (JWH-               45 g  No change.
 200).
1-Butyl-3-(1-naphthoyl)indole (JWH-073)..................            45 g  No change.
1-Cyclohexylethyl-3-(2-methoxyphenylacetyl)indole (SR-18             45 g  No change.
 and RCS-8).
1-Hexyl-3-(1-naphthoyl)indole (JWH-019)..................            45 g  No change.
1-Methyl-4-phenyl-4-propionoxypiperidine.................             2 g  No change.
1-Pentyl-3-(1-naphthoyl)indole (JWH-018 and AM678).......            45 g  No change.
1-Pentyl-3-(2-chlorophenylacetyl)indole (JWH-203)........            45 g  No change.
1-Pentyl-3-(2-methoxyphenylacetyl)indole (JWH-250).......            45 g  No change.
1-Pentyl-3-(4-chloro-1-naphthoyl)indole (JWH-398)........            45 g  No change.
1-Pentyl-3-(4-methyl-1-naphthoyl)indole (JWH-122)........            45 g  No change.
1-Pentyl-3-[(4-methoxy)-benzoyl]indole (SR-19, RCS-4)....            45 g  No change.
1-Pentyl-3-[1-(4-methoxynaphthoyl)]indole (JWH-081)......            45 g  No change.
2-(2,5-Dimethoxy-4-(n)-propylphenyl)ethanamine (2C-P)....            15 g  No change.
2-(2,5-Dimethoxy-4-ethylphenyl)ethanamine (2C-E).........            15 g  No change.
2-(2,5-Dimethoxy-4-methylphenyl)ethanamine (2C-D)........            15 g  No change.
2-(2,5-Dimethoxy-4-nitro-phenyl)ethanamine (2C-N)........            15 g  No change.
2-(2,5-Dimethoxyphenyl)ethanamine (2C-H).................            15 g  No change.
2-(4-Chloro-2,5-dimethoxyphenyl)ethanamine (2C-C)........            15 g  No change.
2-(4-Iodo-2,5-dimethoxyphenyl)ethanamine (2C-I)..........            15 g  No change.
2,5-Dimethoxy-4-ethylamphetamine (DOET)..................            12 g  No change.
2,5-Dimethoxy-4-n-propylthiophenethylamine...............            12 g  No change.
2,5-Dimethoxyamphetamine.................................            12 g  No change.
2-[4-(Ethylthio)-2,5-dimethoxyphenyl]ethanamine (2C-T-2).            15 g  No change.
2-[4-(Isopropylthio)-2,5-dimethoxyphenyl]ethanamine (2C-T-           15 g  No change.
 4).
3,4,5-Trimethoxyamphetamine..............................            12 g  No change.
3,4-Methylenedioxyamphetamine (MDA)......................            30 g  No change.
3,4-Methylenedioxymethamphetamine (MDMA).................            35 g  50 g.
3,4-Methylenedioxy-N-ethylamphetamine (MDEA).............            24 g  No change.
3,4-Methylenedioxy-N-methylcathinone (methylone).........            35 g  No change.
3,4-Methylenedioxypyrovalerone (MDPV)....................            25 g  No change.
3-Methylfentanyl.........................................             2 g  No change.
3-Methylthiofentanyl.....................................             2 g  No change.
4-Bromo-2,5-dimethoxyamphetamine (DOB)...................            12 g  No change.
4-Bromo-2,5-dimethoxyphenethylamine (2-CB)...............            12 g  No change.
4-Methoxyamphetamine.....................................            88 g  No change.
4-Methyl-2,5-dimethoxyamphetamine (DOM)..................            12 g  25 g.
4-Methylaminorex.........................................            12 g  No change.
4-Methyl-N-methylcathinone (mephedrone)..................            25 g  No change.
5-(1,1-Dimethylheptyl)-2-[(1R,3S)-3-hydroxycyclohexyl]-              68 g  No change.
 phenol.
5-(1,1-Dimethyloctyl)-2-[(1R,3S)-3-hydroxycyclohexyl]-               53 g  No change.
 phenol (cannabicyclohexanol or CP-47, 497 C8-homolog).
5-Methoxy-3,4-methylenedioxyamphetamine..................            12 g  No change.
5-Methoxy-N,N-diisopropyltryptamine......................            12 g  No change.
5-Methoxy-N,N-dimethyltryptamine.........................            10 g  No change.
Acetyl-alpha-methylfentanyl..............................             2 g  No change.
Acetyldihydrocodeine.....................................             2 g  No change.
Acetylmethadol...........................................             2 g  No change.
Allylprodine.............................................             2 g  No change.
Alphacetylmethadol.......................................             2 g  No change.
Alpha-ethyltryptamine....................................            12 g  No change.
Alphameprodine...........................................             2 g  No change.
Alphamethadol............................................             2 g  No change.
Alpha-methylfentanyl.....................................             2 g  No change.
Alpha-methylthiofentanyl.................................             2 g  No change.
Alpha-methyltryptamine (AMT).............................            12 g  No change.
Aminorex.................................................            12 g  No change.
Benzylmorphine...........................................             2 g  No change.
Betacetylmethadol........................................             2 g  No change.
Beta-hydroxy-3-methylfentanyl............................             2 g  No change.
Beta-hydroxyfentanyl.....................................             2 g  No change.

[[Page 37240]]

 
Betameprodine............................................             2 g  No change.
Betamethadol.............................................             2 g  No change.
Betaprodine..............................................             2 g  No change.
Bufotenine...............................................             3 g  No change.
Cathinone................................................            12 g  No change.
Codeine-N-oxide..........................................           602 g  No change.
Desomorphine.............................................             5 g  No change.
Diethyltryptamine........................................            12 g  No change.
Difenoxin................................................            50 g  No change.
Dihydromorphine..........................................     3,300,000 g  No change.
Dimethyltryptamine.......................................            18 g  No change.
Gamma-hydroxybutyric acid................................    46,250,000 g  No change.
Heroin...................................................            25 g  No change.
Hydromorphinol...........................................            54 g  No change.
Hydroxypethidine.........................................             2 g  No change.
Ibogaine.................................................             5 g  No change.
Lysergic acid diethylamide (LSD).........................            30 g  No change.
Marihuana................................................        21,000 g  No change.
Mescaline................................................            13 g  No change.
Methaqualone.............................................            10 g  No change.
Methcathinone............................................            14 g  No change.
Methyldihydromorphine....................................             2 g  No change.
Morphine-N-oxide.........................................           655 g  No change.
N,N-Dimethylamphetamine..................................            12 g  No change.
N-Benzylpiperazine.......................................            15 g  No change.
N-Ethylamphetamine.......................................            12 g  No change.
N-Hydroxy-3,4-methylenedioxyamphetamine..................            12 g  No change.
Noracymethadol...........................................             2 g  No change.
Norlevorphanol...........................................            52 g  No change.
Normethadone.............................................             2 g  No change.
Normorphine..............................................            18 g  No change.
Para-fluorofentanyl......................................             2 g  No change.
Phenomorphan.............................................             2 g  No change.
Pholcodine...............................................             2 g  No change.
Properidine..............................................             2 g  No change.
Psilocybin...............................................             2 g  10 g.
Psilocyn.................................................             4 g  No change.
Tetrahydrocannabinols....................................       491,000 g  No change.
Thiofentanyl.............................................             2 g  No change.
Tilidine.................................................            10 g  No change.
Trimeperidine............................................             2 g  No change.
----------------------------------------------------------------------------------------------------------------
                                                   Schedule II
----------------------------------------------------------------------------------------------------------------
1-Phenylcyclohexylamine..................................             3 g  No change.
1-Piperdinocyclohexanecarbonitrile.......................            21 g  No change.
4-Anilino-N-phenethyl-4-piperidine (ANPP)................     2,250,000 g  No change.
Alfentanil...............................................        38,250 g  No change.
Alphaprodine.............................................             3 g  No change.
Amobarbital..............................................             9 g  No change.
Amphetamine (for conversion).............................    22,875,000 g  No change.
Amphetamine (for sale)...................................    42,625,000 g  47,186,000 g.
Carfentanil..............................................             6 g  No change.
Cocaine..................................................       240,000 g  No change.
Codeine (for conversion).................................    81,250,000 g  No change.
Codeine (for sale).......................................    49,506,250 g  No change.
Dextropropoxyphene.......................................            19 g  No change.
Dihydrocodeine...........................................       250,000 g  No change.
Diphenoxylate............................................       750,000 g  No change.
Ecgonine.................................................       127,500 g  144,000 g.
Ethylmorphine............................................             3 g  No change.
Fentanyl.................................................     2,108,750 g  No change.
Glutethimide.............................................             3 g  No change.
Hydrocodone (for sale)...................................    99,625,000 g  No change.
Hydromorphone............................................     5,968,750 g  No change.
Isomethadone.............................................             5 g  No change.
Levo-alphacetylmethadol (LAAM)...........................             4 g  No change.
Levomethorphan...........................................             6 g  No change.
Levorphanol..............................................         4,500 g  No change.
Lisdexamfetamine.........................................    21,000,000 g  No change.
Meperidine...............................................     6,875,000 g  No change.

[[Page 37241]]

 
Meperidine Intermediate--A...............................             6 g  No change.
Meperidine Intermediate--B...............................            11 g  No change.
Meperidine Intermediate--C...............................             6 g  No change.
Metazocine...............................................             6 g  No change.
Methadone (for sale).....................................    25,000,000 g  33,125,000 g.
Methadone Intermediate...................................    32,500,000 g  40,500,000 g.
Methamphetamine..........................................     3,912,500 g  No change.
----------------------------------------------------------------------------------------------------------------
[987,500 grams of levo-desoxyephedrine for use in a non-controlled, non-prescription product; 2,863,750 grams
 for methamphetamine mostly for conversion to a schedule III product; and 61,250 grams for methamphetamine (for
 sale)]
----------------------------------------------------------------------------------------------------------------
Methylphenidate..........................................    80,750,000 g  96,750,000 g.
Morphine (for conversion)................................   103,750,000 g  91,250,000 g.
Morphine (for sale)......................................    60,250,000 g  No change.
Nabilone.................................................        25,628 g  No change.
Noroxymorphone (for conversion)..........................     9,000,000 g  No change.
Noroxymorphone (for sale)................................       508,750 g  1,262,500 g.
Opium (powder)...........................................        91,250 g  No change.
Opium (tincture).........................................     1,287,500 g  No change.
Oripavine................................................    22,750,000 g  No change.
Oxycodone (for conversion)...............................    10,250,000 g  No change.
Oxycodone (for sale).....................................   131,500,000 g  153,750,000 g.
Oxymorphone (for conversion).............................    18,375,000 g  No change.
Oxymorphone (for sale)...................................     6,875,000 g  No change.
Pentobarbital............................................    42,500,000 g  No change.
Phenazocine..............................................             6 g  No change.
Phencyclidine............................................            30 g  No change.
Phenmetrazine............................................             3 g  No change.
Phenylacetone............................................    20,000,000 g  29,628,750 g.
Racemethorphan...........................................             3 g  No change.
Remifentanil.............................................         3,750 g  No change.
Secobarbital.............................................       215,003 g  No change.
Sufentanil...............................................         6,255 g  No change.
Tapentadol...............................................    13,750,000 g  No change.
Thebaine.................................................   145,000,000 g  No change.
----------------------------------------------------------------------------------------------------------------
                                                List I Chemicals
----------------------------------------------------------------------------------------------------------------
Ephedrine (for conversion)...............................    15,100,000 g  No change.
Ephedrine (for sale).....................................     3,500,000 g  No change.
Phenylpropanolamine (for conversion).....................    25,700,000 g  No change.
Phenylpropanolamine (for sale)...........................     6,100,000 g  No change.
Pseudoephedrine (for sale)...............................   225,000,000 g  No change.
----------------------------------------------------------------------------------------------------------------

    The Deputy Administrator further proposes that aggregate production 
quotas for all other schedule I and II controlled substances included 
in 21 CFR 1308.11 and 1308.12 remain at zero. Pursuant to 21 CFR 
1303.13 and 21 CFR 1315.13, upon consideration of the relevant factors, 
the Deputy Administrator may adjust the 2013 aggregate production 
quotas and assessment of annual needs as needed.

Comments

    Pursuant to 21 CFR 1303.11 and 21 CFR 1315.11, any interested 
person may submit written comments on or objections to these proposed 
determinations. Based on comments received in response to this Notice, 
the Deputy Administrator may hold a public hearing on one or more 
issues raised. In the event the Deputy Administrator decides in his 
sole discretion to hold such a hearing, the Deputy Administrator will 
publish a notice of any such hearing in the Federal Register. After 
consideration of any comments and after a hearing, if one is held, the 
Deputy Administrator will publish in the Federal Register a Final Order 
establishing any adjustment of 2013 aggregate production quota for each 
basic class of controlled substance and assessment of annual needs for 
the list I chemicals ephedrine, pseudoephedrine, and 
phenylpropanolamine.

    Dated: June 14, 2013.
Thomas M. Harrigan,
Deputy Administrator.
[FR Doc. 2013-14723 Filed 6-19-13; 8:45 am]
BILLING CODE 4410-09-P