[Federal Register Volume 81, Number 141 (Friday, July 22, 2016)]
[Notices]
[Pages 47821-47826]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-17370]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. DEA-443N]


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 2017

AGENCY: Drug Enforcement Administration, Department of Justice.

ACTION: Notice with request for comments.

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SUMMARY: The Drug Enforcement Administration (DEA) proposes to 
establish the 2017 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 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 22, 2016. 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.
    Based on comments received in response to this notice, the 
Administrator may hold a public hearing on one or more issues raised. 
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 or 
objections, or after a hearing, if one is held, the Administrator will 
publish in the Federal Register a final order establishing the 2017 
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-443N'' 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 http://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/ODW, 8701 Morrissette Drive, 
Springfield, Virginia 22152.

FOR FURTHER INFORMATION CONTACT: Michael J. Lewis, 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 by the Drug Enforcement 
Administration (DEA) 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

[[Page 47822]]

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 
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 confidential business information or personal 
identifying information that it cannot be effectively redacted, all or 
part of that comment may not be made publicly available. Comments 
posted to http://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 confidential.
    An electronic copy of this document is available at http://www.regulations.gov for easy reference.

Legal Authority

    Section 306 of the Controlled Substances Act (CSA) (21 U.S.C. 826) 
requires the Attorney General to establish aggregate production quotas 
for each basic class of controlled substance listed in schedules I and 
II and for 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 2017 Aggregate Production Quotas and Assessment 
of Annual Needs

    The proposed year 2017 aggregate production quotas and assessment 
of annual needs 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 2017 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 2017 aggregate production quotas and 
assessment of annual needs, the Acting Administrator has taken into 
account the criteria pursuant to 21 U.S.C. 826(a) and in accordance 
with 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 DEA proposes 
the aggregate production quotas and assessment of annual needs for 2017 
by considering: (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 import 
quotas requested in accordance with 21 CFR 1303.12, 1315.32, and 
1315.34; and (5) other factors affecting medical, scientific, research, 
and industrial needs of the United States and lawful export 
requirements, as the Acting Administrator finds relevant. These quotas 
do not include imports of controlled substances for use in industrial 
processes.
    Other factors the Acting 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 2017 assessment of annual needs, the DEA used 
the calculation methodology previously described in the 2010 and 2011 
assessment of annual needs (74 FR 60294, Nov. 20, 2009, and 75 FR 
79407, Dec. 20, 2010, respectively).
    During the calendar years 2013-2016, the DEA included an additional 
25% of the estimated medical, scientific, and research needs for the 
United States as part of the amount necessary to ensure the 
establishment and maintenance of reserve stocks for all schedule II 
aggregate production quotas, and certain schedule I aggregate 
production quotas (difenoxin, gamma-hydroxybutyric acid, and 
tetrahydrocannabinols). Based on interagency discussions beginning in 
November 2015, and after reviewing all relevant quota applications 
received, published FDA drug shortage lists, and subsequent reports 
required under 21 U.S.C. 826a for those calendar years, the Acting 
Administrator has determined that inclusion of the additional 25% of 
the estimated medical, scientific, and research needs for the United 
States is unnecessary. Instead, the Acting Administrator determined 
that 21 U.S.C. 826(c) and 21 U.S.C. 952(a)(2)(A) provide sufficient 
ability for the DEA to mitigate adverse public effects should a natural 
disaster or other unforeseen event result in substantial disruption to 
the amount of controlled substances available for legitimate public 
need. As such, DEA proposes to remove the additional 25% from the 
aggregate production quotas. The resulting proposed established 
aggregate production quotas reflect these reduced amounts.
    The Acting Administrator, therefore, proposes to establish the 2017 
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:

------------------------------------------------------------------------
                                                         Proposed 2017
                     Basic class                           quotas (g)
------------------------------------------------------------------------
                               Schedule I
------------------------------------------------------------------------
[1-(5-fluoropentyl)-1H-indazol-3-yl](naphthalen-1-                    15
 yl)methanone (THJ-2201).............................
1-(1-Phenylcyclohexyl)pyrrolidine....................                 10
1-(5-Fluoropentyl)-3-(1-naphthoyl)indole (AM2201)....                 30
1-(5-Fluoropentyl)-3-(2-iodobenzoyl)indole (AM694)...                 30
1-[1-(2-Thienyl)cyclohexyl]piperidine................                 15
1-[2-(4-Morpholinyl)ethyl]-3-(1-naphthoyl)indole (JWH-                35
 200)................................................
1-Benzylpiperazine...................................                 25

[[Page 47823]]

 
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)...                 35
1-Pentyl-3-(2-chlorophenylacetyl)indole (JWH-203)....                 30
1-Pentyl-3-(2-methoxyphenylacetyl)indole (JWH-250)...                 30
1-Pentyl-3-(4-chloro-1-naphthoyl)indole (JWH-398)....                 30
1-Pentyl-3-(4-methyl-1-naphthoyl)indole (JWH-122)....                 30
1-Pentyl-3-[(4-methoxy)-benzoyl]indole (SR-19, RCS-4)                 30
1-Pentyl-3-[1-(4-methoxynaphthoyl)]indole (JWH-081)..                 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-Dimethoxy-4-n-propylphenyl)ethanamine (2C-P)..                 30
2-(2,5-Dimethoxyphenyl)ethanamine (2C-H).............                 30
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-                                   5
 methoxybenzyl)ethanamine (25I-NBOMe; 2C-I-NBOMe;
 25I; Cimbi-5).......................................
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).....                 40
3,4-Methylenedioxypyrovalerone (MDPV)................                 35
3-FMC; 3-Fluoro-N-methylcathinone....................                 25
3-Methylfentanyl.....................................                  2
3-Methylthiofentanyl.................................                  2
4-Bromo-2,5-dimethoxyamphetamine (DOB)...............                 25
4-Bromo-2,5-dimethoxyphenethylamine (2-CB)...........                 25
4-FMC; Flephedrone...................................                 25
4-Methoxyamphetamine.................................                150
4-Methyl-2,5-dimethoxyamphetamine (DOM)..............                 25
4-Methylaminorex.....................................                 25
4-MEC; 4-Methyl-N-ethylcathinone.....................                 25
4-Methyl-N-methylcathinone (mephedrone)..............                 45
4-Methyl-[alpha]-pyrrolidinopropiophenone (4-MePPP)..                 25
5-(1,1-Dimethylheptyl)-2-[(1R,3S)-3-                                  50
 hydroxycyclohexyl]-phenol...........................
5-(1,1-Dimethyloctyl)-2-[(1R,3S)-3-hydroxycyclohexyl]-                40
 phenol (cannabicyclohexanol or CP-47,497 C8-homolog)
5-Fluoro-UR144, XLR11................................                 25
5-Methoxy-3,4-methylenedioxyamphetamine..............                 25
5-Methoxy-N,N-diisopropyltryptamine..................                 25
5-Methoxy-N,N-dimethyltryptamine.....................                 25
AB-PINACA............................................                 15
Acetyl-alpha-methylfentanyl..........................                  2
Acetyldihydrocodeine.................................                  2
Acetylmethadol.......................................                  2
AH-7921..............................................                 30
Allylprodine.........................................                  2
alpha-Ethyltryptamine................................                 25
alpha-Methylfentanyl.................................                  2
alpha-Methylthiofentanyl.............................                  2
alpha-Methyltryptamine (AMT).........................                 25
alpha-Pyrrolidinobutiophenone ([alpha]-PBP)..........                 25
alpha-Pyrrolidinopentiophenone ([alpha]-PVP).........                 25
Alphacetylmethadol...................................                  2
Alphameprodine.......................................                  2
Alphamethadol........................................                  2
Aminorex.............................................                 25
APINCA, AKB48........................................                 25
Benzylmorphine.......................................                  2
beta-Hydroxy-3-methylfentanyl........................                  2
beta-Hydroxyfentanyl.................................                  2
beta-Hydroxythiofentanyl.............................                 30
Betacetylmethadol....................................                  2
Betameprodine........................................                  2

[[Page 47824]]

 
Betamethadol.........................................                  4
Betaprodine..........................................                  2
Bufotenine...........................................                  3
Butylone.............................................                 25
Butyryl fentanyl.....................................                 30
Cathinone............................................                 24
Codeine methylbromide................................                  5
Codeine-N-oxide......................................                305
Desomorphine.........................................                 25
Diethyltryptamine....................................                 25
Difenoxin............................................              8,750
Dihydromorphine......................................          1,566,000
Dimethyltryptamine...................................                 35
Dipipanone...........................................                  5
Fenethylline.........................................                  5
gamma-Hydroxybutyric acid............................         56,200,000
Heroin...............................................                 25
Hydromorphinol.......................................                  2
Hydroxypethidine.....................................                  2
Ibogaine.............................................                  5
Lysergic acid diethylamide (LSD).....................                 10
Marihuana............................................            472,000
Mescaline............................................                 25
Methaqualone.........................................                 10
Methcathinone........................................                 25
Methyldesorphine.....................................                  5
Methyldihydromorphine................................                  2
Morphine methylbromide...............................                  5
Morphine methylsulfonate.............................                  5
Morphine-N-oxide.....................................                350
N,N-Dimethylamphetamine..............................                 25
N-(1-Amino-3,3-dimethyl-1-oxobutan-2-yl)-1-pentyl-1H-                 50
 indazole-3-carboxamide (ADB-PINACA).................
N-(1-Amino-3-methyl-1-oxobutan-2-yl)-1-(4-                            50
 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-phenethylpiperidin-4-yl)-N-phenylacetamide                      100
 (acetyl fentanyl)...................................
N-Ethyl-1-phenylcyclohexylamine......................                  5
N-Ethylamphetamine...................................                 24
N-Hydroxy-3,4-methylenedioxyamphetamine..............                 24
Naphyrone............................................                 25
Noracymethadol.......................................                  2
Norlevorphanol.......................................                 52
Normethadone.........................................                  2
Normorphine..........................................                 40
Para-fluorofentanyl..................................                  5
Parahexyl............................................                  5
Pentedrone...........................................                 25
Pentylone............................................                 25
Phenomorphan.........................................                  2
Pholcodine...........................................                  5
Psilocybin...........................................                 30
Psilocyn.............................................                 50
Quinolin-8-yl 1-(5-fluoropentyl)-1H-indole-3-                         20
 carboxylate (5-fluoro-PB-22; 5F-PB-22)..............
Quinolin-8-yl 1-pentyl-1H-indole-3-carboxylate (PB-                   20
 22; QUPIC)..........................................
Tetrahydrocannabinols................................            409,000
Thiofentanyl.........................................                  2
Tilidine.............................................                 25
Trimeperidine........................................                  2
UR-144...............................................                 25
------------------------------------------------------------------------
                               Schedule II
------------------------------------------------------------------------
1-Phenylcyclohexylamine..............................                  4
1-Piperidinocyclohexanecarbonitrile..................                  4
4-Anilino-N-phenethyl-4-piperidine (ANPP)............          1,000,000
Alfentanil...........................................              4,200
Alphaprodine.........................................                  2
Amobarbital..........................................             20,100
Amphetamine (for conversion).........................          9,000,000
Amphetamine (for sale)...............................         37,500,000
Carfentanil..........................................                 10
Cocaine..............................................             94,000
Codeine (for conversion).............................         40,000,000
Codeine (for sale)...................................         45,000,000

[[Page 47825]]

 
Dextropropoxyphene...................................                 15
Dihydrocodeine.......................................             81,100
Dihydroetorphine.....................................                  2
Diphenoxylate (for conversion).......................             15,000
Diphenoxylate (for sale).............................            820,000
Ecgonine.............................................             90,000
Ethylmorphine........................................                  2
Etorphine hydrochloride..............................                  2
Fentanyl.............................................          1,750,000
Glutethimide.........................................                  2
Hydrocodone (for conversion).........................            122,000
Hydrocodone (for sale)...............................         58,410,000
Hydromorphone........................................          4,300,000
Isomethadone.........................................                  4
Levo-alphacetylmethadol (LAAM).......................                  3
Levomethorphan.......................................                 10
Levorphanol..........................................              4,900
Lisdexamfetamine.....................................         19,000,000
Meperidine...........................................          3,706,000
Meperidine Intermediate-A............................                  5
Meperidine Intermediate-B............................                  9
Meperidine Intermediate-C............................                  5
Metazocine...........................................                 15
Methadone (for sale).................................         23,700,000
Methadone Intermediate...............................         25,600,000
Methamphetamine......................................          1,539,100
------------------------------------------------------------------------
[900,000 grams of levo-desoxyephedrine for use in a non-controlled, non-
   prescription product; 600,000 grams for methamphetamine mostly for
       conversion to a schedule III product; and 39,100 grams for
                       methamphetamine (for sale)]
------------------------------------------------------------------------
Methylphenidate......................................         73,000,000
Morphine (for conversion)............................         27,300,000
Morphine (for sale)..................................         41,000,000
Nabilone.............................................             15,000
Noroxymorphone (for conversion)......................         17,700,000
Noroxymorphone (for sale)............................            400,000
Opium (powder).......................................             90,000
Opium (tincture).....................................            300,000
Oripavine............................................         20,000,000
Oxycodone (for conversion)...........................          2,610,000
Oxycodone (for sale).................................        108,510,000
Oxymorphone (for conversion).........................         22,300,000
Oxymorphone (for sale)...............................          4,200,000
Pentobarbital........................................         27,500,000
Phenazocine..........................................                  5
Phencyclidine........................................                 20
Phenmetrazine........................................                  2
Phenylacetone........................................                 20
Racemethorphan.......................................                  2
Racemorphan..........................................                  2
Remifentanil.........................................              3,000
Secobarbital.........................................            172,002
Sufentanil...........................................              4,000
Tapentadol...........................................         21,000,000
Thebaine.............................................        100,000,000
------------------------------------------------------------------------
                            List I Chemicals
------------------------------------------------------------------------
Ephedrine (for conversion)...........................             50,000
Ephedrine (for sale).................................          4,100,000
Phenylpropanolamine (for conversion).................         15,000,000
Phenylpropanolamine (for sale).......................          8,500,000
Pseudoephedrine (for sale)...........................        200,000,000
------------------------------------------------------------------------

    The Acting 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. In accordance with 21 CFR 
1303.13 and 21 CFR 1315.13, upon consideration of the relevant factors, 
the Acting Administrator may adjust the 2017 aggregate production 
quotas and assessment of annual needs as needed.

Conclusion

    After consideration of any comments or objections, or after a 
hearing, if one is held, the Acting Administrator will issue and 
publish in the Federal Register a final order establishing the

[[Page 47826]]

2017 aggregate production quota for controlled substances in schedules 
I and II and establishing an assessment of annual needs for the list I 
chemicals ephedrine, pseudoephedrine, and phenylpropanolamine, 21 CFR 
1303.11(c) and 1315.11(f).

    Dated: July 14, 2016.
Chuck Rosenberg,
Acting Administrator.
[FR Doc. 2016-17370 Filed 7-21-16; 8:45 am]
 BILLING CODE 4410-09-P