ACTION:
Notice of application.
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 in accordance with 21 CFR 1301.33(a) on or before November 30, 2015.
ADDRESSES:
Written comments should be sent to: Drug Enforcement Administration, Attention: DEA Federal Register Representative/ODXL, 8701 Morrissette Drive, Springfield, Virginia 22152. Request for hearings should be sent to: Drug Enforcement Administration, Attention: Hearing Clerk/LJ, 8701 Morrissette Drive, Springfield, Virginia 22152.
SUPPLEMENTARY INFORMATION:
The Attorney General has delegated her 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 Deputy Assistant Administrator of the DEA Office of Diversion Control (“Deputy 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 July 15, 2015, Cerilliant Corporation, 811 Paloma Drive, Suite A, Round Rock, Texas 78665-2402, applied to be registered as a bulk manufacturer of the following basic classes of controlled substances:
| Controlled substance | Schedule |
|---|---|
| 3-Fluoro-N-methylcathinone (3-FMC) (1233) | I |
| Cathinone (1235) | I |
| Methcathinone (1237) | I |
| 4-Fluoro-N-methylcathinone (4-FMC) (1238) | I |
| Pentedrone (a-methylaminovalerophenone) (1246) | I |
| 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 |
| JWH-250 (1-Pentyl-3-(2-methoxyphenylacetyl) indole) (6250) | I |
| SR-18 and RCS-8 (1-Cyclohexylethyl-3-(2-methoxyphenylacetyl) indole) (7008) | I |
| 5-Fluoro-UR-144 and XLR11 [1-(5-flouro-pentyl) | |
| 1H-indol-3-yl](2,2,3,3-tetramethylcyclopropyl) methanone (7011) | I |
| AB-FUBINACA (N-(1-amino-3-methyl-1-oxobutan-2-yl)-1-(4-fluorobenzyl)-1H-indazole-3-carboxamide) (7012) | I |
| JWH-019 (1-Hexyl-3-(1-naphthoyl)indole) (7019) | I |
| AB-PINACA (N-amino-3-methyl-1-oxobutan-2-yl)-1-pentyl-1H-indazole-3-carboxamide (7023) | I |
| THJ-2201 [1-(5-fluoropentyl)-1H-indazol-3-yl](naphthalene-1-yl)methanone (7024) | I |
| AB-CHIMINACA (N-(1-amino-3-methyl-1-oxobutan-2-yl)-1-(cyclohenxylmethyl)-1H-indazole-3-carboxamide (7031) | I |
| ADB-PINACA (N-(1-amino-3,3-dimethyl-1-oxobutan-2-yl)-1-pentyl-1H-indazole-3-carboxamide) (7035) | I |
| APINACA and AKB48 N-(1-Adamantyl)-1-pentyl-1H-indazole-3-carboxamide (7048) | I |
| JWH-081 (1-Pentyl-3-(1-(4-methoxynaphthoyl) indole) (7081) | I |
| SR-19 and RCS-4 (1-Pentyl-3[(4-methoxy)-benzoyl] indole (7104) | I |
| JWH-018 (also known as AM678) (1-Pentyl-3-(1-naphthoyl) indole) (7118) | I |
| JWH-122 (1-Pentyl-3-(4-methyl-1-naphthoyl) indole) (7122) | I |
| UR-144 (1-pentyl-1H-indol-3-yl)(2,2,3,3- | |
| tetramethylcyclopropyl)methanone (7144) | I |
| JWH-073 (1-Butyl-3-(1-naphthoyl)indole) (7173) | I |
| JWH-200 (1-[2-(4-Morpholinyl)ethyl]-3-(1-naphthoyl) indole) (7200) | I |
| AM-2201 (1-(5-Fluoropentyl)-3-(1-naphthoyl) indole) (7201) | I |
| JWH-203 (1-Pentyl-3-(2-chlorophenylacetyl) indole) (7203) | I |
| PB-22 (Quinolin-8-yl 1-pentyl-1H-indole-3-carboxylate) (7222) | I |
| 5F-PB-22 (Quinolin-8-yl 1-(5-fluoropentyl)-1H-indole-3-carboxylate) (7225) | I |
| Alpha-ethyltryptamine (7249) | I |
| CP-47,497 (5-(1,1-Dimethylheptyl)-2-[(1R,3S)-3-hydroxycyclohexyl-phenol) (7297) | I |
| CP-47,497 C8 Homologue (5-(1,1-Dimethyloctyl)-2-[(1R,3S) 3-hydroxycyclohexyl-phenol) (7298) | I |
| Lysergic acid diethylamide (7315) | I |
| 2,5-Dimethoxy-4-(n)-propylthiophenethylamine (2C-T-7) (7348) | I |
| Marihuana (7360) | I |
| Tetrahydrocannabinols (7370) | I |
| Parahexyl (7374) | I |
| Mescaline (7381) | I |
| 2-(4-Ethylthio-2,5-dimethoxyphenyl) ethanamine (2C-T-2) (7385) | I |
| 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-naphthoyl) indole (7398) | I |
| 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 |
| Bufotenine (7433) | 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 |
| N-Benzylpiperazine (7493) | I |
| 4-Methyl-alphapyrrolidinopropiophenone (4-mePPP) (7498) | I |
| 2-(2,5-Dimethoxy-4-methylphenyl) ethanamine (2C-D) (7508) | I |
| 2-(2,5-Dimethoxy-4-ethylphenyl) ethanamine (2C-E) (7509) | I |
| 2-(2,5-Dimethoxyphenyl) ethanamine (2C-H) (7517) | I |
| 2-(4-lodo-2,5-dimethoxyphenyl) ethanamine (2C-I) (7518) | I |
| 2-(4-Chloro-2,5-dimethoxyphenyl) ethanamine (2C-C) (7519) | I |
| 2-(2,5-Dimethoxy-4-nitro-phenyl) ethanamine (2C-N) (7521) | I |
| 2-(2,5-Dimethoxy-4-(n)-propylphenyl) ethanamine (2C-P) (7524) | I |
| 2-(4-Isopropylthio)-2,5-dimethoxyphenyl) ethanamine (2C-T-4) (7532) | I |
| MDPV (3,4-Methylenedioxypyrovalerone) (7535) | I |
| 2-(4-bromo-2,5-dimethoxyphenyl)-N-(2-methoxybenzyl) ethanamine (25B-NBOMe) (7536) | I |
| 2-(4-chloro-2,5-dimethoxyphenyl) N-(2-methoxybenzyl) ethanamine (25C-NBOMe) (7537) | I |
| 2-(4-iodo-2,5-dimethoxyphenyl)-N-(2-methoxybenzyl) ethanamine (25I-NBOMe) (7538) | I |
| Methylone (3,4-Methylenedioxy-N-methylcathinone) (7540) | I |
| Butylone (7541) | I |
| Pentylone (7542) | I |
| alpha-pyrrolidinopentiophenone (a-PVP) (7545) | I |
| alpha-pyrrolidinobutiophenone (a-PBP) (7546) | I |
| AM-694 (1-(5-Fluoropentyl)-3-(2-iodobenzoyl) indole) (7694) | I |
| Acetyldihydrocodeine (9051) | I |
| Benzylmorphine (9052) | I |
| Codeine-N-oxide (9053) | I |
| Desomorphine (9055) | I |
| Codeine methylbromide (9070) | I |
| Dihydromorphine (9145) | I |
| Heroin (9200) | I |
| Hydromorphinol (9301) | I |
| Methyldesorphine (9302) | I |
| Methyldihydromorphine (9304) | I |
| Morphine methylbromide (9305) | I |
| Morphine methylsulfonate (9306) | I |
| Morphine-N-oxide (9307) | I |
| Normorphine (9313) | I |
| Pholcodine (9314) | I |
| Acetylmethadol (9601) | I |
| Allylprodine (9602) | I |
| Alphacetylmethadol except levo-alphacetylmethadol (9603) | I |
| Alphameprodine (9604) | I |
| Alphamethadol (9605) | I |
| Betacetylmethadol (9607) | I |
| Betameprodine (9608) | I |
| Betamethadol (9609) | I |
| Betaprodine (9611) | I |
| Dipipanone (9622) | I |
| Hydroxypethidine (9627) | I |
| Noracymethadol (9633) | I |
| Norlevorphanol (9634) | I |
| Normethadone (9635) | I |
| Trimeperidine (9646) | I |
| Phenomorphan (9647) | I |
| 1-Methyl-4-phenyl-4-propionoxypiperidine (9661) | I |
| Tilidine (9750) | I |
| Para-Fluorofentanyl (9812) | I |
| 3-Methylfentanyl (9813) | I |
| Alpha-methylfentanyl (9814) | I |
| Acetyl-alpha-methylfentanyl (9815) | I |
| Beta-hydroxyfentanyl (9830) | I |
| Beta-hydroxy-3-methylfentanyl (9831) | I |
| Alpha-methylthiofentanyl (9832) | I |
| 3-Methylthiofentanyl (9833) | I |
| Thiofentanyl (9835) | I |
| Amphetamine (1100) | II |
| Methamphetamine (1105) | II |
| Lisdexamfetamine (1205) | II |
| Phenmetrazine (1631) | II |
| Methylphenidate (1724) | II |
| Amobarbital (2125) | II |
| Pentobarbital (2270) | II |
| Secobarbital (2315) | II |
| Glutethimide (2550) | II |
| Nabilone (7379) | II |
| 1-Phenylcyclohexylamine (7460) | II |
| Phencyclidine (7471) | II |
| 1-Piperidinocyclohexanecarbonitrile (8603) | II |
| Alphaprodine (9010) | II |
| Cocaine (9041) | II |
| Codeine (9050) | II |
| Dihydrocodeine (9120) | II |
| Oxycodone (9143) | II |
| Hydromorphone (9150) | II |
| Diphenoxylate (9170) | II |
| Ecgonine (9180) | II |
| Ethylmorphine (9190) | II |
| Hydrocodone (9193) | II |
| Levomethorphan (9210) | II |
| Levorphanol (9220) | II |
| Isomethadone (9226) | II |
| Meperidine (9230) | II |
| Meperidine intermediate-A (9232) | II |
| Meperidine intermediate-B (9233) | II |
| Meperidine intermediate-C (9234) | II |
| Metazocine (9240) | II |
| Methadone (9250) | II |
| Methadone intermediate (9254) | II |
| Dextropropoxyphene, bulk (non-dosage forms) (9273) | II |
| Morphine (9300) | II |
| Thebaine (9333) | II |
| Levo-alphacetylmethadol (9648) | II |
| Oxymorphone (9652) | II |
| Noroxymorphone (9668) | II |
| Racemethorphan (9732) | II |
| Alfentanil (9737) | II |
| Remifentanil (9739) | II |
| Sufentanil (9740) | II |
| Carfentanil (9743) | II |
| Tapentadol (9780) | II |
| Fentanyl (9801) | II |
The company plans to manufacture small quantities of the listed controlled substances to make reference standards which will be distributed to their customers.
Dated: September 21, 2015.
Joseph T. Rannazzisi,
Deputy Assistant Administrator.
[FR Doc. 2015-24748 Filed 9-29-15; 8:45 am]
BILLING CODE 4410-09-P