[Federal Register Volume 83, Number 78 (Monday, April 23, 2018)]
[Notices]
[Pages 17678-17681]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-08348]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. DEA-392]


Bulk Manufacturer of Controlled Substances Application: Cayman 
Chemical Company

ACTION: Notice of application.

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DATES: Registered bulk manufacturers of the affected basic classes, and 
applicants therefore, may file written comments on or objections to the 
issuance of the proposed registration on or before June 22, 2018.

ADDRESSES: Written comments should be sent to: Drug Enforcement 
Administration, Attention: DEA Federal Register Representative/DRW, 
8701 Morrissette Drive, Springfield, Virginia 22152.

SUPPLEMENTARY INFORMATION: The Attorney General has delegated his 
authority under the Controlled Substances Act to the Administrator of 
the Drug Enforcement Administration (DEA), 28 CFR 0.100(b). Authority 
to exercise all necessary functions with respect to the promulgation 
and implementation of 21 CFR part 1301, incident to the registration of 
manufacturers, distributors, dispensers, importers, and exporters of 
controlled substances (other than final orders in connection with 
suspension, denial, or revocation of registration) has been redelegated 
to the Assistant Administrator of the DEA Diversion Control Division 
(``Assistant Administrator'') pursuant to section 7 of 28 CFR part 0, 
appendix to subpart R.
    In accordance with 21 CFR 1301.33(a), this is notice that on March 
8, 2018, Cayman Chemical Company, 1180 East Ellsworth Road, Ann Arbor, 
Michigan 48108 applied to be registered as a bulk manufacturer of the 
following basic classes of controlled substances:

------------------------------------------------------------------------
          Controlled substance               Drug code       Schedule
------------------------------------------------------------------------
3-Fluoro-N-methylcathinone (3-FMC)......            1233               I
Cathinone...............................            1235               I
Methcathinone...........................            1237               I
4-Fluoro-N-methylcathinone (4-FMC)......            1238               I
Pentedrone ([alpha]-                                1246               I
 methylaminovalerophenone)..............
Mephedrone (4-Methyl-N-methylcathinone).            1248               I
4-Methyl-N-ethylcathinone (4-MEC).......            1249               I
Naphyrone...............................            1258               I
N-Ethylamphetamine......................            1475               I
N,N-Dimethylamphetamine.................            1480               I
Fenethylline............................            1503               I
Aminorex................................            1585               I
4-Methylaminorex (cis isomer)...........            1590               I
Gamma Hydroxybutyric Acid...............            2010               I
Methaqualone............................            2565               I
Mecloqualone............................            2572               I
JWH-250 (1-Pentyl-3-(2-                             6250               I
 methoxyphenylacetyl) indole)...........
SR-18 (Also known as RCS-8) (1-                     7008               I
 Cyclohexylethyl-3-(2-
 methoxyphenylacetyl) indole)...........
ADB-FUBINACA (n-(1-amino-3,3-dimethyl-1-            7010               I
 oxobutan-2-yl)-1-(4-fluorobenzyl)-1H-
 indazole-3-carboxamide)................
5-Flouro-UR-144 and XLR11 [1-(5-Fluoro-             7011               I
 pentyl)1H-indol-3-yl](2,2,3,3-
 tetramethylcyclopropyl)methanone.......
AB-FUBINACA (N-(1-amino-3-methyl-1-                 7012               I
 oxobutan-2-yl)-1-(4-fluorobenzyl)-1H-
 indazole-3-carboxamide)................
JWH-019 (1-Hexyl-3-(1-naphthoyl)indole).            7019               I
MDMB-FUBINACA (Methyl 2-(1-4-                       7020               I
 fluorobenzyl)-1H-indazole-3-
 carboxamido)-3,3-dimethylbutanoate)....
2-(1-(4-fluorobenzyl)-1Hindazole-3-                 7021               I
 carboxamido)-3- methylbutanoate........
AB-PINACA (N-(1-amino-3-methyl-.........            7023               I
1-oxobutan-2-yl)-1-pentyl-1H-indazole-..
3-carboxamide)..........................
THJ-2201 [1-(5-fluoropentyl)-1H-indazol-            7024               I
 3-.....................................
yl](naphthalen-1-yl)methanone...........
AB-CHMINACA (N-(1-amino-3-methyl-1-.....            7031               I
oxobutan-2-yl)-1-(cyclohexylmethyl)-....
1H-indazole-3-carboxamide...............
MAB-CHMINACA (N-(1-amino-3,3dimethyl-1-             7032               I
 oxobutan-2-yl)-1-(cyclohexylmethyl)-1H-
 indazole-3-carboxamide)................
5F-AMB (Methyl 2-(1-(5-fluoropentyl)-1H-            7033               I
 indazola-3-carboxamido)-3-
 methylbutanoate).......................
5F-ADB; 5F-MDMB-PINACA (Methyl 2-(1-                7034               I
 (5fluoropentyl)-1H-indazole-3-
 carboxamido)-3,3dimethylbutanoate).....
ADB-PINACA (N-(1-amino-3,3-dimethyl-1-              7035               I
 oxobutan-2-yl)-1-pentyl-1H-indazole-3-
 carboxamide)...........................
MDMB-CHMICA, MMB-CHMINACA (Methyl 2-(1-             7042               I
 (cyclohenxylmethyl)-1H-indole-3-
 carboxamido)-3,3-dimethylbutanote)-....
APINACA and AKB48 N-(1-Adamantyl)-1-                7048               I
 pentyl-1H-indazole-3-carboxamide.......

[[Page 17679]]

 
5F-APINACA, 5F-AKB48 (N-(adamantan-1-yl)-           7049               I
 1-(5fluoropentyl)-1H-indazole-3-
 carboxamide)...........................
JWH-081 (1-Pentyl-3-(1-(4-                          7081               I
 methoxynaphthoyl) indole)..............
SR-19 (Also known as RCS-4) (1-Pentyl-3-            7104               I
 [(4-methoxy)-benzoyl] indole...........
JWH-018 (also known as AM678) (1-Pentyl-            7118               I
 3-(1-naphthoyl)indole).................
JWH-122 (1-Pentyl-3-(4-methyl-1-                    7122               I
 naphthoyl) indole).....................
UR-144 (1-Pentyl-1H-indol-3-yl)(2,2,3,3-            7144               I
 tetramethylcyclopropyl)methanone.......
JWH-073 (1-Butyl-3-(1-naphthoyl)indole).            7173               I
JWH-200 (1-[2-(4-Morpholinyl)ethyl]-3-(1-           7200               I
 naphthoyl)indole)......................
AM2201 (1-(5-Fluoropentyl)-3-(1-                    7201               I
 naphthoyl) indole).....................
JWH-203 (1-Pentyl-3-(2-                             7203               I
 chlorophenylacetyl) indole)............
PB-22 (Quinolin-8-yl 1-pentyl-1H-indole-            7222               I
 3-carboxylate).........................
5F-PB-22 (Quinolin-8-yl 1-(5-                       7225               I
 fluoropentyl)-1H-indole-3-carboxylate).
Alpha-ethyltryptamine...................            7249               I
Ibogaine................................            7260               I
CP-47,497 (5-(1,1-Dimethylheptyl)-2-                7297               I
 [(1R,3S)-3-hydroxycyclohexyl-phenol)...
CP-47,497 C8 Homologue (5-(1,1-                     7298               I
 Dimethyloctyl)-2-[(1R,3S)3-
 hydroxycyclohexyl-phenol)..............
Lysergic acid diethylamide..............            7315               I
2,5-Dimethoxy-4-(n)-                                7348               I
 propylthiophenethylamine (2C-T-7)......
Marihuana...............................            7360               I
Tetrahydrocannabinols...................            7370               I
Mescaline...............................            7381               I
2-(4-Ethylthio-2,5-dimethoxyphenyl)                 7385               I
 ethanamine (2C-T-2 )...................
3,4,5-Trimethoxyamphetamine.............            7390               I
4-Bromo-2,5-dimethoxyamphetamine........            7391               I
4-Bromo-2,5-dimethoxyphenethylamine.....            7392               I
4-Methyl-2,5-dimethoxyamphetamine.......            7395               I
2,5-Dimethoxyamphetamine................            7396               I
JWH-398 (1-Pentyl-3-(4-chloro-1-                    7398               I
 naphthoyl) indole).....................
2,5-Dimethoxy-4-ethylamphetamine........            7399               I
3,4-Methylenedioxyamphetamine...........            7400               I
5-Methoxy-3,4-methylenedioxyamphetamine.            7401               I
N-Hydroxy-3,4-methylenedioxyamphetamine.            7402               I
3,4-Methylenedioxy-N-ethylamphetamine...            7404               I
3,4-Methylenedioxymethamphetamine.......            7405               I
4-Methoxyamphetamine....................            7411               I
5-Methoxy-N-N-dimethyltryptamine........            7431               I
Alpha-methyltryptamine..................            7432               I
Diethyltryptamine.......................            7434               I
Dimethyltryptamine......................            7435               I
Psilocybin..............................            7437               I
Psilocyn................................            7438               I
5-Methoxy-N,N-diisopropyltryptamine.....            7439               I
N-Ethyl-1-phenylcyclohexylamine.........            7455               I
1-(1-Phenylcyclohexyl)pyrrolidine.......            7458               I
1-[1-(2-Thienyl)cyclohexyl]piperidine...            7470               I
1-[1-(2-Thienyl)cyclohexyl]pyrrolidine..            7473               I
N-Benzylpiperazine......................            7493               I
2-(2,5-Dimethoxy-4-methylphenyl)                    7508               I
 ethanamine (2C-D)......................
2-(2,5-Dimethoxy-4-ethylphenyl)                     7509               I
 ethanamine (2C-E ).....................
2-(2,5-Dimethoxyphenyl) ethanamine (2C-             7517               I
 H).....................................
2-(4-iodo-2,5-dimethoxyphenyl)                      7518               I
 ethanamine (2C-I)......................
2-(4-Chloro-2,5-dimethoxyphenyl)                    7519               I
 ethanamine (2C-C)......................
2-(2,5-Dimethoxy-4-nitro-phenyl)                    7521               I
 ethanamine (2C-N)......................
2-(2,5-Dimethoxy-4-(n)-propylphenyl)                7524               I
 ethanamine (2C-P)......................
2-(4-Isopropylthio)-2,5-dimethoxyphenyl)            7532               I
 ethanamine (2C-T-4 )...................
MDPV (3,4-Methylenedioxypyrovalerone)...            7535               I
2-(4-bromo-2,5-dimethoxyphenyl)-N-(2-               7536               I
 methoxybenzyl) ethanamine (25B-NBOMe)..
2-(4-chloro-2,5-dimethoxyphenyl)-N-(2-              7537               I
 methoxybenzyl).........................
ethanamine (25C-NBOMe)..................
2-(4-iodo-2,5-dimethoxyphenyl)-N-(2-                7538               I
 methoxybenzyl) ethanamine (25I-NBOMe)..
Methylone (3,4-Methylenedioxy-N-                    7540               I
 methylcathinone).......................
Butylone................................            7541               I
Pentylone...............................            7542               I
alpha-pyrrolidinopentiophenone ([alpha]-            7545               I
 PVP)...................................
alpha-pyrrolidinobutiophenone ([alpha]-             7546               I
 PBP)...................................
AM-694 (1-(5-Fluoropentyl)-3-(2-                    7694               I
 iodobenzoyl) indole)...................
Acetyldihydrocodeine....................            9051               I
Benzylmorphine..........................            9052               I
Codeine-N-oxide.........................            9053               I
Desomorphine............................            9055               I
Etorphine (except HCl)..................            9056               I
Codeine methylbromide...................            9070               I
Dihydromorphine.........................            9145               I
Heroin..................................            9200               I

[[Page 17680]]

 
Morphine-N-oxide........................            9307               I
Normorphine.............................            9313               I
U-47700 (3,4-dichloro-N-[2-                         9547               I
 (dimethylamino)cyclohexyl]-N-
 methylbenzamide).......................
MT-45 (1-cyclohexyl-4-(1,2-                         9560               I
 diphenylethyl)piperazine)).............
Tilidine................................            9750               I
Acryl fentanyl (N-(1-phenethylpiperidin-            9811               I
 4-yl)-N-phenylacrylamide)..............
Para-Fluorofentanyl.....................            9812               I
3-Methylfentanyl........................            9813               I
Alpha-methylfentanyl....................            9814               I
Acetyl-alpha-methylfentanyl.............            9815               I
N-(2-fluorophenyl)-N-(1-                            9816               I
 phenethylpiperidin-4-yl)propionamide...
Acetyl Fentanyl (N-(1-phenethylpiperidin-           9821               I
 4-yl)-N-phenylacetamide)...............
Butyryl Fentanyl........................            9822               I
Para-fluorobutyryl fentanyl.............            9823               I
4-Fluoroisobutyryl fentanyl (N-(4-                  9824               I
 fluorophenyl)-N-(1phenethylpiperidin-4-
 yl)isobutyramide)......................
2-methoxy-N-(1-phenethylpiperidin-4-yl)-            9825               I
 N-phenylacetamide......................
Para-chloroisobutyryl fentanyl..........            9826               I
Isobutyryl fentanyl.....................            9827               I
Beta-hydroxyfentanyl....................            9830               I
Beta-hydroxy-3-methylfentanyl...........            9831               I
Alpha-methylthiofentanyl................            9832               I
3-Methylthiofentanyl....................            9833               I
Furanyl fentanyl (N-(1-                             9834               I
 phenethylpiperidin-4-yl)-N-phenylfuran-
 2-carboxamide).........................
Thiofentanyl............................            9835               I
Beta-hydroxythiofentanyl................            9836               I
Para-methoxybutyryl fentanyl............            9837               I
Ocfentanil..............................            9838               I
Valeryl fentanyl........................            9840               I
N-(1-phenethylpiperidin-4-yl)-N-                    9843               I
 phenyltetrahydrofuran-2-carboxamide....
Cyclopropyl Fentanyl....................            9845               I
Cyclopentyl fentanyl....................            9847               I
Fentanyl related-compounds as defined in            9850               I
 21 CFR 1308.11(h)......................
Amphetamine.............................            1100              II
Methamphetamine.........................            1105              II
Lisdexamfetamine........................            1205              II
Phenmetrazine...........................            1631              II
Methylphenidate.........................            1724              II
Amobarbital.............................            2125              II
Pentobarbital...........................            2270              II
Secobarbital............................            2315              II
Phencyclidine...........................            7471              II
4-Anilino-N-phenethyl-4-piperidine                  8333              II
 (ANPP).................................
Phenylacetone...........................            8501              II
1-Piperidinocyclohexanecarbonitrile.....            8603              II
Cocaine.................................            9041              II
Codeine.................................            9050              II
Etorphine HCl...........................            9059              II
Dihydrocodeine..........................            9120              II
Oxycodone...............................            9143              II
Hydromorphone...........................            9150              II
Ecgonine................................            9180              II
Ethylmorphine...........................            9190              II
Hydrocodone.............................            9193              II
Levomethorphan..........................            9210              II
Levorphanol.............................            9220              II
Isomethadone............................            9226              II
Meperidine..............................            9230              II
Meperidine intermediate-B...............            9233              II
Methadone...............................            9250              II
Dextropropoxyphene, bulk (non-dosage                9273              II
 forms).................................
Morphine................................            9300              II
Thebaine................................            9333              II
Oxymorphone.............................            9652              II
Thiafentanil............................            9729              II
Alfentanil..............................            9737              II
Remifentanil............................            9739              II
Sufentanil..............................            9740              II
Carfentanil.............................            9743              II
Tapentadol..............................            9780              II
Fentanyl................................            9801              II
------------------------------------------------------------------------


[[Page 17681]]

    The company plans to manufacture bulk controlled substances for use 
in product development of analytical reference standards for 
distribution to its customers.
    The company will manufacture marihuana (7360) and 
tetrahydrocannabinols (7370) for use by their researchers under the 
above-listed controlled substances as Active Pharmaceutical Ingredient 
(API) for clinical trials.
    In reference to drug code (7370) the company plans to bulk 
manufacture a synthetic tetrahydrocannabinol. No other activities for 
this drug code are authorized for this registration.

    Dated: April 13, 2018.
Susan A. Gibson,
Deputy Assistant Administrator.
[FR Doc. 2018-08348 Filed 4-20-18; 8:45 am]
 BILLING CODE 4410-09-P