Proposed 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 2016, 42540-42544 [2015-17561]

Agencies

• Drug Enforcement Administration
• Department of Justice

[Federal Register Volume 80, Number 137 (Friday, July 17, 2015)]
[Notices]
[Pages 42540-42544]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-17561]



[[Page 42540]]

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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. DEA-420N]


Proposed 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 2016

AGENCY: Drug Enforcement Administration, Department of Justice.

ACTION: Notice with request for comments.

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

SUMMARY: The Drug Enforcement Administration proposes to establish the 
2016 aggregate production quotas for 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 or objections to 
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 August 17, 2015. Commenters should be aware 
that the electronic Federal Docket Management System will not accept 
comments after 11:59 p.m. Eastern Time on the last day of the comment 
period.
    The Administrator may hold a public hearing on one or more issues 
raised by the comments received in response to this notice. In the 
event the Administrator decides in his sole discretion to hold such a 
hearing, the 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 Administrator will publish in the Federal 
Register a final order establishing the 2016 aggregate production 
quotas for schedule I and II controlled substances, and an assessment 
of annual needs for the list I chemicals ephedrine, pseudoephedrine, 
and phenylpropanolamine.

ADDRESSES: To ensure proper handling of comments, please reference 
``Docket No. DEA-420N'' on all correspondence, including any 
attachments. The Drug Enforcement Administration encourages that all 
comments be submitted electronically through the Federal eRulemaking 
Portal which provides the ability to type short comments directly into 
the comment field on the Web page or attach a file for lengthier 
comments. Please go to https://www.regulations.gov and follow the online 
instructions at that site for submitting comments. Upon completion of 
your submission you will receive a Comment Tracking Number for your 
comment. Please be aware that submitted comments are not 
instantaneously available for public view on Regulations.gov. If you 
have received a Comment Tracking Number, your comment has been 
successfully submitted and there is no need to resubmit the same 
comment. Paper comments that duplicate electronic submissions are not 
necessary and are discouraged. Should you wish to mail a paper comment 
in lieu of an electronic comment, it should be sent via regular or 
express mail to: Drug Enforcement Administration, Attention: DEA 
Federal Register Representative/ODL, 8701 Morrissette Drive, 
Springfield, Virginia 22152.

FOR FURTHER INFORMATION CONTACT: John R. Scherbenske, Office of 
Diversion Control, Drug Enforcement Administration; Mailing Address: 
8701 Morrissette Drive, Springfield, Virginia 22152, Telephone: (202) 
598-6812.

SUPPLEMENTARY INFORMATION:

Posting of Public Comments

    Please note that all comments received in response to this docket 
are considered part of the public record. They will, unless reasonable 
cause is given, be made available for public inspection online at 
https://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 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 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 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 
confidential business information to be redacted within the comment.
    Comments containing personal identifying information or 
confidential business information identified and located as directed 
above will generally be made available in redacted form. If a comment 
contains so much personal identifying information or confidential 
business information that it cannot be effectively redacted, all or 
part of that comment may not be made publicly available. Comments 
posted to https://www.regulations.gov may include any personal 
identifying information (such as name, address, and phone number) 
included in the text of your electronic submission that is not 
identified as directed above as personal.
    An electronic copy of this document is available at https://www.regulations.gov for easy reference.

Legal Authority

    The Drug Enforcement Administration (DEA) implements and enforces 
titles II and III of the Comprehensive Drug Abuse Prevention and 
Control Act of 1970, as amended. 21 U.S.C. 801-971. Titles II and III 
are referred to as the ``Controlled Substances Act'' and the 
``Controlled Substances Import and Export Act,'' respectively, and are 
collectively referred to as the ``Controlled Substances Act'' or the 
``CSA'' for the purpose of this action. The DEA publishes the 
implementing regulations for these statutes in title 21 of the Code of 
Federal Regulations (CFR), chapter II. The CSA and its implementing 
regulations are designed to prevent, detect, and eliminate the 
diversion of controlled substances and listed chemicals into the 
illicit market while ensuring an adequate supply is available for the 
legitimate medical, scientific, research, and industrial needs of the 
United States. Controlled substances have the potential for abuse and 
dependence and are controlled to protect the public health and safety.
    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 to establish 
the assessment of annual needs for the list I chemicals ephedrine, 
pseudoephedrine, and phenylpropanolamine. The Attorney General has 
delegated this function to the Administrator of the DEA pursuant to 28 
CFR 0.100.

Analysis for Proposed 2016 Aggregate Production Quotas and Assessment 
of Annual Needs

    The proposed year 2016 aggregate production quotas and assessment 
of annual needs represent those quantities

[[Page 42541]]

of schedule I and II controlled substances, and the list I chemicals 
ephedrine, pseudoephedrine, and phenylpropanolamine, to be manufactured 
in the United States in 2016 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 proposals include estimated imports of ephedrine, 
pseudoephedrine, and phenylpropanolamine but do not include estimated 
imports of controlled substances for use in industrial processes.
    In determining the proposed 2016 aggregate production quotas and 
assessment of annual needs, the Administrator has taken into account 
the criteria that is required to be considered 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). The 
Administrator estimates the aggregate production quotas and assessment 
of annual needs for 2016 by considering the following factors: (1) 
Total net disposal of each 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 each class 
or chemical as indicated by procurement and chemical import quotas 
requested in accordance with 21 CFR 1303.12, 1315.32, and 1315.34; and 
(5) other factors affecting the medical, scientific, research, and 
industrial needs of the United States, lawful export requirements, and 
reserve stocks, as the Administrator finds relevant.
    Other factors the Administrator 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 2016 assessment of annual needs, the DEA used 
the calculation methodology previously described in the 2010 and 2011 
assessments of annual needs (74 FR 60294, Nov. 20, 2009, and 75 FR 
79407, Dec. 20, 2010, respectively).
    The Administrator 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 of concern 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 Administrator proposes to include in all schedule II 
aggregate production quotas, and certain schedule I aggregate 
production quotas (difenoxin, 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 
proposed aggregate production quotas reflect these included amounts. 
This action will not affect the ability of manufacturers to maintain 
inventory allowances as specified by regulation. The Administrator 
expects that maintaining this reserve in certain established aggregate 
production quotas will mitigate adverse public effects if an unforeseen 
event results in substantial disruption to the amount of controlled 
substances available to provide for legitimate public need, as 
determined by the Administrator. The Administrator does not anticipate 
utilizing the reserve in the absence of these circumstances.
    The Administrator, therefore, proposes to establish the 2016 
aggregate production quotas for the following basic classes of 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:

------------------------------------------------------------------------
                                                         Proposed 2016
                     Basic class                           quotas (g)
------------------------------------------------------------------------
                               Schedule I
------------------------------------------------------------------------
(1-Pentyl-1H-indol-3-yl)(2,2,3,3-                                     25
 tetramethylcyclopropyl)methanone (UR-144)...........
[1-(5-Fluoro-pentyl)-1H-indol-3-yl](2,2,3,3-                          25
 tetramethylcyclopropyl)methanone (XLR11)............
[1-(5-fluoropentyl)-1H-indazol-3-yl](naphthalen-1-                    15
 yl)methanone (THJ-2201).............................
1-(1,3-Benzodioxol-5-yl)-2-(methylamino)butan-1-one                   25
 (butylone)..........................................
1-(1,3-Benzodioxol-5-yl)-2-(methylamino)pentan-1-one                  25
 (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-                45
 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 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

[[Page 42542]]

 
2-(4-Bromo-2,5-dimethoxyphenyl)-N-(2-                                 25
 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-                                25
 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)....                 25
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-                30
 2)..................................................
2-[4-(Isopropylthio)-2,5-dimethoxyphenyl]ethanamine                   30
 (2C-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)...................                 25
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)...................                 25
4-Methoxyamphetamine.................................                150
4-Methyl-2,5-dimethoxyamphetamine (DOM)..............                 25
4-Methylaminorex.....................................                 25
4-Methyl-N-ethylcathinone (4-MEC)....................                 25
4-Methyl-N-methylcathinone (mephedrone)..............                 45
4-Methyl-[alpha]-pyrrolidinopropiophenone (4-MePPP)..                 25
5-(1,1-Dimethylheptyl)-2-[(1R,3S)-3-                                  68
 hydroxycyclohexyl]-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
alpha-Methylthiofentanyl.............................                  2
alpha-Methyltryptamine (AMT).........................                 25
alpha-Pyrrolidinobutiophenone ([alpha]-PBP)..........                 25
alpha-Pyrrolidinopentiophenone ([alpha]-PVP).........                 25
Aminorex.............................................                 25
Benzylmorphine.......................................                  2
Betacetylmethadol....................................                  2
beta-Hydroxy-3-methylfentanyl........................                  2
beta-Hydroxyfentanyl.................................                  2
Betameprodine........................................                  2
Betamethadol.........................................                  4
Betaprodine..........................................                  2
Bufotenine...........................................                  3
Cathinone............................................                 70
Codeine methylbromide................................                  5
Codeine-N-oxide......................................                305
Desomorphine.........................................                 25
Diethyltryptamine....................................                 25
Difenoxin............................................             11,000
Dihydromorphine......................................          3,000,000
Dimethyltryptamine...................................                 35
Dipipanone...........................................                  5
Fenethylline.........................................                  5
gamma-Hydroxybutyric acid............................         70,250,000
Heroin...............................................                 50
Hydromorphinol.......................................                  2
Hydroxypethidine.....................................                  2
Ibogaine.............................................                  5
Lysergic acid diethylamide (LSD).....................                 40

[[Page 42543]]

 
Marihuana............................................            200,000
Mescaline............................................                 25
Methaqualone.........................................                 10
Methcathinone........................................                 25
Methyldesorphine.....................................                  5
Methyldihydromorphine................................                  2
Morphine methylbromide...............................                  5
Morphine methylsulfonate.............................                  5
Morphine-N-oxide.....................................                350
N-(1-Adamantyl)-1-pentyl-1H-indazole-3-carboxamide                    25
 (AKB48).............................................
N-(1-Amino-3,3-dimethyl-1-oxobutan-2-yl)-1-pentyl-1H-                 25
 indazole-3-carboxamide (ADB-PINACA).................
N-(1-Amino-3-methyl-1-oxobutan-2-yl)-1-(4-                            25
 fluorobenzyl)-1H-indazole-3-carboxamide (AB-
 FUBINACA)...........................................
N-(1-Amino-3-methyl-1-oxobutan-2-yl)-1-                               15
 (cyclohexylmethyl)-1H-indazole-3-carboxamide (AB-
 CHMINACA)...........................................
N-(1-Amino-3-methyl-1-oxobutan-2-yl)-1-pentyl-1H-                     15
 indazole-3-carboxamide (AB-PINACA)..................
N,N-Dimethylamphetamine..............................                 25
Naphthylpyrovalerone (naphyrone).....................                 25
N-Benzylpiperazine...................................                 25
N-Ethyl-1-phenylcyclohexylamine......................                  5
N-Ethylamphetamine...................................                 24
N-Hydroxy-3,4-methylenedioxyamphetamine..............                 24
Noracymethadol.......................................                  2
Norlevorphanol.......................................                 52
Normethadone.........................................                  2
Normorphine..........................................                 40
Para-fluorofentanyl..................................                  5
Parahexyl............................................                  5
Phenomorphan.........................................                  2
Pholcodine...........................................                  5
Psilocybin...........................................                 30
Psilocyn.............................................                 50
Quinolin-8-yl 1-(5-fluoropentyl)-1H-indole-3-                         25
 carboxylate (5-fluoro-PB-22; 5F-PB-22)..............
Quinolin-8-yl 1-pentyl-1H-indole-3-carboxylate (PB-                   25
 22; QUPIC)..........................................
Tetrahydrocannabinols................................            511,250
Thiofentanyl.........................................                  2
Tilidine.............................................                 25
Trimeperidine........................................                  2
------------------------------------------------------------------------
                               Schedule II
------------------------------------------------------------------------
1-Phenylcyclohexylamine..............................                  5
1-Piperidinocyclohexanecarbonitrile..................                  5
4-Anilino-N-phenethyl-4-piperidine (ANPP)............          2,950,000
Alfentanil...........................................             17,750
Alphaprodine.........................................                  3
Amobarbital..........................................             25,125
Amphetamine (for conversion).........................         15,000,000
Amphetamine (for sale)...............................         37,500,000
Carfentanil..........................................                 19
Cocaine..............................................            200,000
Codeine (for conversion).............................         50,000,000
Codeine (for sale)...................................         63,900,000
Dextropropoxyphene...................................                 45
Dihydrocodeine.......................................            226,375
Diphenoxylate (for conversion).......................             31,250
Diphenoxylate (for sale).............................          1,337,500
Ecgonine.............................................            125,000
Ethylmorphine........................................                  3
Fentanyl.............................................          2,300,000
Glutethimide.........................................                  3
Hydrocodone (for conversion).........................            235,000
Hydrocodone (for sale)...............................         88,500,000
Hydromorphone........................................          7,000,000
Isomethadone.........................................                  5
Levo-alphacetylmethadol (LAAM).......................                  4
Levomethorphan.......................................                 30
Levorphanol..........................................              7,125
Lisdexamfetamine.....................................         29,750,000
Meperidine...........................................          5,450,000
Meperidine Intermediate-A............................                  6
Meperidine Intermediate-B............................                 11
Meperidine Intermediate-C............................                  6
Metazocine...........................................                 19

[[Page 42544]]

 
Methadone (for sale).................................         31,875,000
Methadone Intermediate...............................         34,375,000
Methamphetamine......................................          2,061,375
------------------------------------------------------------------------
  [1,250,000 grams of levo-desoxyephedrine for use in a non-controlled,
 non-prescription product; 750,000 grams for methamphetamine mostly for
       conversion to a schedule III product; and 61,375 grams for
                       methamphetamine (for sale)]
------------------------------------------------------------------------
Methylphenidate......................................         87,500,000
Morphine (for conversion)............................         91,250,000
Morphine (for sale)..................................         62,500,000
Nabilone.............................................             18,750
Noroxymorphone (for conversion)......................         17,500,000
Noroxymorphone (for sale)............................          1,475,000
Opium (powder).......................................            112,500
Opium (tincture).....................................            687,500
Oripavine............................................         30,000,000
Oxycodone (for conversion)...........................          6,250,000
Oxycodone (for sale).................................        139,150,000
Oxymorphone (for conversion).........................         29,000,000
Oxymorphone (for sale)...............................          7,750,000
Pentobarbital........................................         38,125,000
Phenazocine..........................................                  6
Phencyclidine........................................                 50
Phenmetrazine........................................                  3
Phenylacetone........................................                 50
Racemethorphan.......................................                  3
Remifentanil.........................................              3,750
Secobarbital.........................................            215,003
Sufentanil...........................................              6,255
Tapentadol...........................................         25,500,000
Thebaine.............................................        125,000,000
------------------------------------------------------------------------
                            List I Chemicals
------------------------------------------------------------------------
Ephedrine (for conversion)...........................            100,000
Ephedrine (for sale).................................          4,000,000
Phenylpropanolamine (for conversion).................         22,400,000
Phenylpropanolamine (for sale).......................          8,500,000
Pseudoephedrine (for conversion).....................              7,000
Pseudoephedrine (for sale)...........................        224,500,000
------------------------------------------------------------------------

    The Administrator further proposes that the aggregate production 
quotas for all other basic classes of schedule I and II controlled 
substances included in 21 CFR 1308.11 and 1308.12 remain at zero. In 
accordance with 21 CFR 1303.13 and 21 CFR 1315.13, upon consideration 
of the relevant factors, the Administrator may adjust the 2016 
aggregate production quotas and assessment of annual needs as 
necessary.

    Dated: July 13, 2015.
Chuck Rosenberg,
Acting Administrator.
[FR Doc. 2015-17561 Filed 7-16-15; 8:45 am]
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