[Federal Register Volume 77, Number 150 (Friday, August 3, 2012)]
[Notices]
[Pages 46519-46523]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2012-19052]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. DEA-365]


Proposed Aggregate Production Quotas for Schedule I and II 
Controlled Substances and Proposed 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 initial year 2013 aggregate production 
quotas for 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.

DATES: Electronic comments must be submitted and written comments must 
be postmarked on or before September 4, 2012. 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-365'' on all electronic and written correspondence. 
DEA encourages that 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 
the http://www.regulations.gov Web site for easy reference. Paper 
comments that duplicate the electronic submission are not necessary as 
all comments submitted to http://www.regulations.gov will be posted for 
public review and are part of the official docket record. Written 
comments submitted via regular or express mail 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, Chief, Liaison and 
Policy Section, Drug Enforcement Administration, 8701 Morrissette 
Drive, Springfield, VA 22152, Telephone: (202) 307-4654.

SUPPLEMENTARY INFORMATION: 

[[Page 46520]]

Posting of Public Comments

    Please note that all comments received are considered part of the 
public record and made available for public inspection online at 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 by 28 CFR 0.100. The 
Administrator, in turn, has redelegated this function to the Deputy 
Administrator, pursuant to 28 CFR 0.104.
    The proposed year 2013 aggregate production quotas represent those 
quantities of schedule I and II controlled substances, and the list I 
chemicals ephedrine, pseudoephedrine, and phenylpropanolamine, 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 include imports of 
ephedrine, pseudoephedrine, and phenylpropanolamine but do not include 
imports of controlled substances for use in industrial processes.
    In determining the proposed 2013 aggregate production quotas and 
assessment of annual needs, DEA has taken into account the criteria 
that DEA is required to consider in accordance with 21 U.S.C. 826(a), 
21 CFR 1303.11 (aggregate production quotas for controlled substances), 
and 21 CFR 1315.11 (assessment of annual needs for ephedrine, 
pseudoephedrine, and phenylpropanolamine). DEA proposes the aggregate 
production quotas and assessment of annual needs for 2013 by 
considering (1) total net disposal of the class or chemical by all 
manufacturers and chemical importers during the current and two 
preceding years; (2) trends in the national rate of net disposal of the 
class or chemical; (3) total actual (or estimated) inventories of the 
class or chemical and of all substances manufactured from the class or 
chemical, and trends in inventory accumulation; (4) projected demand 
for such class or chemical as indicated by procurement and chemical 
import quotas requested pursuant to 21 CFR 1303.12, 1315.32, and 
1315.34; and (5) other factors affecting the medical, scientific, 
research, and industrial needs in the United States, lawful export 
requirements, and reserve stocks, as the Deputy Administrator finds 
relevant. 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 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).
    DEA also 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 proposes to include 
in all schedule II aggregate production quotas, and certain schedule I 
aggregate production quotas (gamma-hydroxybutyric acid and 
tetrahydrocannabinols), 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 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 
affects 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 and assessment of annual needs for the 
following schedule I and II controlled substances and for the list I 
chemicals ephedrine, pseudoephedrine, and phenylpropanolamine, 
expressed in grams of anhydrous acid or base, be established as 
follows:

[[Page 46521]]



------------------------------------------------------------------------
                                              Proposed  2013  quotas g
------------------------------------------------------------------------
                         Basic Class--Schedule I
------------------------------------------------------------------------
1-(5-Fluoropentyl)-3-(1-naphthoyl)indole                              45
 (AM2201).................................
1-(5-Fluoropentyl)-3-(2-iodobenzoyl)indole                            45
 (AM694)..................................
1-[1-(2-Thienyl)cyclohexyl]piperidine.....                             5
1-[2-(4-Morpholinyl)ethyl]-3-(1-                                      45
 naphthoyl)indole (JWH-200)...............
1-Butyl-3-(1-naphthoyl)indole (JWH-073)...                            45
1-Cyclohexylethyl-3-(2-                                               45
 methoxyphenylacetyl)indole (SR-18 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                               45
 and AM678)...............................
1-Pentyl-3-(2-chlorophenylacetyl)indole                               45
 (JWH-203)................................
1-Pentyl-3-(2-methoxyphenylacetyl)indole                              45
 (JWH-250)................................
1-Pentyl-3-(4-chloro-1-naphthoyl)indole                               45
 (JWH-398)................................
1-Pentyl-3-(4-methyl-1-naphthoyl)indole                               45
 (JWH-122)................................
1-Pentyl-3-[1-(4-methoxynaphthoyl)]indole                             45
 (JWH-081)................................
1-Pentyl-3-[(4-methoxy)-benzoyl]indole (SR-                           45
 19, RCS-4)...............................
2-(2,5-Dimethoxy-4-(n)-                                               15
 propylphenyl)ethanamine (2C-P)...........
2-(2,5-Dimethoxy-4-ethylphenyl)ethanamine                             15
 (2C-E)...................................
2-(2,5-Dimethoxy-4-methylphenyl)ethanamine                            15
 (2C-D)...................................
2-(2,5-Dimethoxy-4-nitro-phenyl)ethanamine                            15
 (2C-N)...................................
2-(2,5-Dimethoxyphenyl)ethanamine (2C-H)..                            15
2-(4-Chloro-2,5-dimethoxyphenyl)ethanamine                            15
 (2C-C)...................................
2-(4-Iodo-2,5-dimethoxyphenyl)ethanamine                              15
 (2C-I)...................................
2,5-Dimethoxy-4-ethylamphetamine (DOET)...                            12
2,5-Dimethoxy-4-n-propylthiophenethylamine                            12
2,5-Dimethoxyamphetamine..................                            12
2-[4-(Ethylthio)-2,5-                                                 15
 dimethoxyphenyl]ethanamine (2C-T-2)......
2-[4-(Isopropylthio)-2,5-                                             15
 dimethoxyphenyl]ethanamine (2C-T-4)......
3-Methylfentanyl..........................                             2
3-Methylthiofentanyl......................                             2
3,4-Methylenedioxyamphetamine (MDA).......                            30
3,4-Methylenedioxy-N-methylcathinone                                  15
 (methylone)..............................
3,4-Methylenedioxy-N-ethylamphetamine                                 24
 (MDEA)...................................
3,4-Methylenedioxymethamphetamine (MDMA)..                            35
3,4-Methylenedioxypyrovalerone (MDPV).....                            15
3,4,5-Trimethoxyamphetamine...............                            12
4-Bromo-2,5-dimethoxyamphetamine (DOB)....                            12
4-Bromo-2,5-dimethoxyphenethylamine (2-CB)                            12
4-Methoxyamphetamine......................                            88
4-Methylaminorex..........................                            12
4-Methyl-2,5-dimethoxyamphetamine (DOM)...                            12
4-Methyl-N-methylcathinone (mephedrone)...                            15
5-(1,1-Dimethylheptyl)-2-[(1R,3S)-3-                                  68
 hydroxycyclohexyl]-phenol................
5-(1,1-Dimethyloctyl)-2-[(1R,3S)-3-                                   53
 hydroxycyclohexyl]-phenol
 (cannabicyclohexanol or CP-47, 497 C8-
 homolog).................................
5-Methoxy-3,4-methylenedioxyamphetamine...                            12
5-Methoxy-N,N-diisopropyltryptamine.......                            12
5-Methoxy-N,N-dimethyltryptamine..........                            10
Acetyl-alpha-methylfentanyl...............                             2
Acetyldihydrocodeine......................                             2
Acetylmethadol............................                             2
Allylprodine..............................                             2
Alphacetylmethadol........................                             2
Alpha-ethyltryptamine.....................                            12
Alphameprodine............................                             2
Alphamethadol.............................                             2
Alpha-methylfentanyl......................                             2
Alpha-methylthiofentanyl..................                             2
Alpha-methyltryptamine (AMT)..............                            12
Aminorex..................................                            12
Benzylmorphine............................                             2
Betacetylmethadol.........................                             2
Beta-hydroxy-3-methylfentanyl.............                             2
Beta-hydroxyfentanyl......................                             2
Betameprodine.............................                             2
Betamethadol..............................                             2
Betaprodine...............................                             2
Bufotenine................................                             3
Cathinone.................................                            12
Codeine-N-oxide...........................                           602
Desomorphine..............................                             5

[[Page 46522]]

 
Diethyltryptamine.........................                            12
Difenoxin.................................                            50
Dihydromorphine...........................                     3,300,000
Dimethyltryptamine........................                            18
Gamma-hydroxybutyric acid.................                    46,250,000
Heroin....................................                            25
Hydromorphinol............................                            54
Hydroxypethidine..........................                             2
Ibogaine..................................                             5
Lysergic acid diethylamide (LSD)..........                            30
Marihuana.................................                        21,000
Mescaline.................................                            13
Methaqualone..............................                            10
Methcathinone.............................                            14
Methyldihydromorphine.....................                             2
Morphine-N-oxide..........................                           655
N-Benzylpiperazine........................                            12
N,N-Dimethylamphetamine...................                            12
N-Ethylamphetamine........................                            12
N-Hydroxy-3,4-methylenedioxyamphetamine...                            12
Noracymethadol............................                             2
Norlevorphanol............................                            52
Normethadone..............................                             2
Normorphine...............................                            18
Para-fluorofentanyl.......................                             2
Phenomorphan..............................                             2
Pholcodine................................                             2
Properidine...............................                             2
Psilocybin................................                             2
Psilocyn..................................                             4
Tetrahydrocannabinols.....................                       491,000
Thiofentanyl..............................                             2
Tilidine..................................                            10
Trimeperidine.............................                             2
------------------------------------------------------------------------
                        Basic Class--Schedule II
------------------------------------------------------------------------
1-Phenylcyclohexylamine...................                             3
1-Piperdinocyclohexanecarbonitrile........                            21
4-Anilino-N-phenethyl-4-piperidine (ANPP).                     2,250,000
Alfentanil................................                        38,250
Alphaprodine..............................                             3
Amobarbital...............................                             9
Amphetamine (for conversion)..............                    18,375,000
Amphetamine (for sale)....................                    38,000,000
Carfentanil...............................                             6
Cocaine...................................                       240,000
Codeine (for conversion)..................                    81,250,000
Codeine (for sale)........................                    49,506,250
Dextropropoxyphene........................                            19
Dihydrocodeine............................                       250,000
Diphenoxylate.............................                       750,000
Ecgonine..................................                       127,500
Ethylmorphine.............................                             3
Fentanyl..................................                     2,108,750
Glutethimide..............................                             3
Hydrocodone (for sale)....................                    78,750,000
Hydromorphone.............................                     4,535,000
Isomethadone..............................                             5
Levo-alphacetylmethadol (LAAM)............                             4
Levomethorphan............................                             6
Levorphanol...............................                         4,500
Lisdexamfetamine..........................                    19,250,000
Meperidine................................                     6,875,000
Meperidine Intermediate-A.................                             6
Meperidine Intermediate-B.................                            11
Meperidine Intermediate-C.................                             6
Metazocine................................                             6
Methadone (for sale)......................                    25,000,000
Methadone Intermediate....................                    32,500,000
Methamphetamine...........................                     3,912,500
------------------------------------------------------------------------

[[Page 46523]]

 
[962,500 grams of levo-desoxyephedrine for
 use in a non-controlled, non-prescription
 product; 2,888,750 grams for
 methamphetamine mostly for conversion to
 a schedule III product; and 61,250 grams
 for methamphetamine (for sale)]..........
------------------------------------------------------------------------
Methylphenidate...........................                    72,250,000
Morphine (for conversion).................                   103,750,000
Morphine (for sale).......................                    51,250,000
Nabilone..................................                        25,628
Noroxymorphone (for conversion)...........                     9,000,000
Noroxymorphone (for sale).................                       508,750
Opium (powder)............................                        91,250
Opium (tincture)..........................                     1,287,500
Oripavine.................................                    22,750,000
Oxycodone (for conversion)................                    10,250,000
Oxycodone (for sale)......................                   123,375,000
Oxymorphone (for conversion)..............                    16,000,000
Oxymorphone (for sale)....................                     6,875,000
Pentobarbital.............................                    42,500,000
Phenazocine...............................                             6
Phencyclidine.............................                            30
Phenmetrazine.............................                             3
Phenylacetone.............................                    20,000,000
Racemethorphan............................                             3
Remifentanil..............................                         2,500
Secobarbital..............................                       215,003
Sufentanil................................                         6,250
Tapentadol................................                    13,500,000
Thebaine..................................                   145,000,000
------------------------------------------------------------------------
                      Basic Class--List I Chemicals
------------------------------------------------------------------------
Ephedrine (for conversion)................                    12,000,000
Ephedrine (for sale)......................                     3,200,000
Phenylpropanolamine (for conversion)......                    25,700,000
Phenylpropanolamine (for sale)............                     4,400,000
Pseudoephedrine (for sale)................                   185,000,000
------------------------------------------------------------------------

    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 be established 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 the 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: July 31, 2012.
Thomas M. Harrigan,
Deputy Administrator.
[FR Doc. 2012-19052 Filed 8-2-12; 8:45 am]
BILLING CODE 4410-09-P