[Federal Register Volume 81, Number 193 (Wednesday, October 5, 2016)]
[Notices]
[Pages 69079-69083]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-23988]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. DEA-443F]


Established 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: Final order.

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SUMMARY: This final order establishes the initial 2017 aggregate 
production quotas for controlled substances in schedules I and II of 
the Controlled Substances Act (CSA) and the assessment of annual needs 
for the list I chemicals ephedrine, pseudoephedrine, and 
phenylpropanolamine.

DATES: Effective October 5, 2016.

FOR FURTHER INFORMATION CONTACT: Michael J. Lewis, Diversion Control 
Division, Drug Enforcement Administration, 8701 Morrissette Drive, 
Springfield, VA 22152, Telephone: (202) 598-6812.

SUPPLEMENTARY INFORMATION: 

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.

Background

    The 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 that may 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.
    On July 22, 2016, a notice titled ``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'' was published in the Federal Register. 
81 FR 47821. This notice proposed the 2017 aggregate production quotas 
for each basic class of controlled substance listed in schedules I and 
II and the 2017 assessment of annual needs for the list I chemicals 
ephedrine, pseudoephedrine, and phenylpropanolamine. All interested 
persons were invited to comment on or object to the proposed aggregate 
production quotas and the proposed assessment of annual needs on or 
before August 22, 2016.

Comments Received

    Thirteen comments were received from five DEA-registered 
manufacturers and four non-DEA registered entities within the published 
comment period regarding 22 different schedule I and II controlled 
substances. The DEA received two comments from two non-DEA registered 
entities within the published comment period regarding the proposed 
assessment of annual needs for the list I chemical ephedrine (for 
sale). Commenters stated that the proposed aggregate production quotas 
for acetyl fentanyl, AH-7921, amphetamine (for conversion), amphetamine 
(for sale), beta-hydroxythiofentanyl, butyryl fentanyl, cocaine, 
codeine (for conversion), codeine (for sale), dihydrocodeine, ecgonine, 
hydrocodone (for sale), hydromorphone, levorphanol, lisdexamfetamine, 
marihuana, meperidine, methylphenidate, nabilone, opium tincture, 
oxycodone (for sale), and sufentanil, as well as, the proposed 
assessment of annual needs for ephedrine (for sale) were insufficient 
to provide for the estimated medical, scientific, research, and 
industrial needs

[[Page 69080]]

of the United States, export requirements, and the establishment and 
maintenance of reserve stocks.
    The DEA received one comment from a DEA-registrant and three 
comments by non-DEA registered entities regarding the proposed removal 
of the additional 25% of the estimated medical, scientific, and 
research needs for the United States. Two of the commenters requested 
that the DEA continue to include the additional 25%, one commenter 
requested transparency in the process of setting aggregate production 
quotas, and the last commenter agreed with the DEA that the additional 
25% should not be included in aggregate production quotas values. The 
DEA has considered these comments, as well as the ones for specific 
controlled substances and ephedrine (for sale), in establishing the 
2017 aggregate production quotas and assessment of annual needs.

Determination of 2017 Aggregate Production Quotas and Assessment of 
Annual Needs

    In determining the 2017 aggregate production quotas and assessment 
of annual needs, the DEA has taken into consideration the above 
comments along with the factors set forth in 21 CFR 1303.11 and 21 CFR 
1315.11, in accordance with 21 U.S.C. 826(a), and other relevant 
factors, including the 2016 manufacturing quotas, current 2016 sales 
and inventories, anticipated 2017 export requirements, industrial use, 
and additional applications for 2017 quotas, as well as information on 
research and product development requirements. Based on this 
information, the DEA has removed the additional 25% from the aggregate 
production quotas before determining that adjustments to the proposed 
aggregate production quotas for 4-anilino-n-phenethyl-piperidine, 
amphetamine (for conversion), amphetamine (for sale), cocaine, 
dihydrocodeine, ecgonine, etorphine hydrochloride, hydromorphone, 
levorphanol, lysergic acid dimethylamide, nabilone, opium tincture, and 
oripavine are warranted. Adjustment to the proposed annual assessment 
of needs for ephedrine (for sale) was also determined to be warranted. 
This final order reflects those adjustments.
    Regarding acetyl fentanyl, AH-7921, beta-hydroxythiofentanyl, 
butyryl fentanyl, codeine (for conversion), codeine (for sale), 
hydrocodone (for sale), lisdexamfetamine, marihuana, meperidine, 
methylphenidate, oxycodone (for sale), and sufentanil, the DEA has 
determined that the proposed aggregate production quotas are sufficient 
to provide for the 2017 estimated medical, scientific, research, and 
industrial needs of the United States, export requirements, and the 
establishment and maintenance of reserve stocks. This final order 
establishes these aggregate production quotas at the same amounts as 
proposed.
    In accordance with 21 U.S.C. 826, 21 CFR 1303.11, and 21 CFR 
1315.11, the Administrator hereby establishes the 2017 aggregate 
production quotas for the following schedule I and II controlled 
substances and the 2017 assessment of annual needs for the list I 
chemicals ephedrine, pseudoephedrine, and phenylpropanolamine, 
expressed in grams of anhydrous acid or base, as follows:

------------------------------------------------------------------------
                                                               2017
                       Basic class                          Established
                                                            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
1-Butyl-3-(1-naphthoyl)indole (JWH-073).................              45
1-Cyclohexylethyl-3-(2-methoxyphenylacetyl)indole (SR-18              45
 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-2)              30
2-[4-(Isopropylthio)-2,5-dimethoxyphenyl]ethanamine (2C-              30
 T-4)...................................................
3,4,5-Trimethoxyamphetamine.............................              25

[[Page 69081]]

 
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-hydroxycyclohexyl]-               50
 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
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)........................              15
Marihuana...............................................         472,000
Mescaline...............................................              25
Methaqualone............................................              10
Methcathinone...........................................              25

[[Page 69082]]

 
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-fluorobenzyl)-              50
 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 (acetyl              100
 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-carboxylate              20
 (5-fluoro-PB-22; 5F-PB-22).............................
Quinolin-8-yl 1-pentyl-1H-indole-3-carboxylate (PB-22;                20
 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)...............       1,750,000
Alfentanil..............................................           4,200
Alphaprodine............................................               2
Amobarbital.............................................          20,100
Amphetamine (for conversion)............................      12,000,000
Amphetamine (for sale)..................................      42,400,000
Carfentanil.............................................              10
Cocaine.................................................         103,400
Codeine (for conversion)................................      40,000,000
Codeine (for sale)......................................      45,000,000
Dextropropoxyphene......................................              15
Dihydrocodeine..........................................         281,100
Dihydroetorphine........................................               2
Diphenoxylate (for conversion)..........................          15,000
Diphenoxylate (for sale)................................         820,000
Ecgonine................................................          99,000
Ethylmorphine...........................................               2
Etorphine hydrochloride.................................              32
Fentanyl................................................       1,750,000
Glutethimide............................................               2
Hydrocodone (for conversion)............................         122,000
Hydrocodone (for sale)..................................      58,410,000
Hydromorphone...........................................       5,140,800
Isomethadone............................................               4
Levo-alphacetylmethadol (LAAM)..........................               3
Levomethorphan..........................................              10
Levorphanol.............................................           8,300
Lisdexamfetamine........................................      19,000,000
Meperidine..............................................       3,706,000
Meperidine Intermediate-A...............................               5
Meperidine Intermediate-B...............................               9
Meperidine Intermediate-C...............................               5
Metazocine..............................................              15

[[Page 69083]]

 
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................................................          19,000
Noroxymorphone (for conversion).........................      17,700,000
Noroxymorphone (for sale)...............................         400,000
Opium (powder)..........................................          90,000
Opium (tincture)........................................         907,200
Oripavine...............................................      22,000,000
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)....................................       5,360,000
Phenylpropanolamine (for conversion)....................      15,000,000
Phenylpropanolamine (for sale)..........................       8,500,000
Pseudoephedrine (for conversion)........................              40
Pseudoephedrine (for sale)..............................     200,000,000
------------------------------------------------------------------------

    The Administrator also establishes aggregate production quotas for 
all other schedule I and II controlled substances included in 21 CFR 
1308.11 and 1308.12 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 2017 aggregate production quotas and 
assessment of annual needs as needed.

    Dated: September 26, 2016.
Chuck Rosenberg,
Acting Administrator.
[FR Doc. 2016-23988 Filed 10-4-16; 8:45 am]
 BILLING CODE 4410-09-P