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Importer of Controlled Substances Application: Research Triangle Institute

84 Fed. Reg. 2571 (Feb. 7, 2019)

Importer of Controlled Substances Application: Research Triangle Institute

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Federal RegisterFeb 7, 2019
84 Fed. Reg. 2571 (Feb. 7, 2019)

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 on or before March 11, 2019. Such persons may also file a written request for a hearing on the application on or before March 11, 2019.

ADDRESSES:

Written comments should be sent to: Drug Enforcement Administration, Attention: DEA Federal Register Representative/DPW, 8701 Morrissette Drive, Springfield, Virginia 22152. All requests for hearing must be sent to: Drug Enforcement Administration, Attn: Administrator, 8701 Morrissette Drive, Springfield, Virginia 22152. All requests for hearing should also be sent to: (1) Drug Enforcement Administration, Attn: Hearing Clerk/OALJ, 8701 Morrissette Drive, Springfield, Virginia 22152; and (2) Drug Enforcement Administration, Attn: DEA Federal Register Representative/DPW, 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 1301.34(a), this is notice that on May 2, 2016, Research Triangle Institute, 3040 East Cornwallis Road, Hermann Bldg., Room 106, Research Triangle Park, North Carolina 27709 has applied to be registered as an importer 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 (α-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
Mecloqualone 2572 I
JWH-250 (1-Pentyl-3-(2-methoxyphenylacetyl) indole) 6250 I
SR-18 (Also known as RCS-8) (1-Cyclohexylethyl-3-(2-methoxyphenylacetyl) indole) 7008 I
5-Fluoro-UR-144 and XLR11 [1-(5-Fluoro-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-(1-amino-3-methyl-1-oxobutan-2-yl)-1-pentyl-1H-indazole3-carboxamide) 7023 I
THJ-2201 [1-(5-fluoropentyl)-1H-indazol-3-yl](naphthalen-1-yl)methanone 7024 I
AB-CHMINACA (N-(1-amino-3-methyl-1-oxobutan-2-yl)-1-(cyclohexylmethyl)1H-indazole-3-carboxamide 7031 I
MAB-CHMINACA (N-(1-amino-3,3dimethyl-1-oxobutan-2-yl)-1-(cyclohexylmethyl)-1H-indazole-3-carboxamide) 7032 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 (Also known as 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
AM2201 (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
Ibogaine 7260 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
Peyote 7415 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
1-[1-(2-Thienyl)cyclohexyl]pyrrolidine 7473 I
N-Ethyl-3-piperidyl benzilate 7482 I
N-Methyl-3-piperidyl benzilate 7484 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-iodo-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 (α-PVP) 7545 I
alpha-pyrrolidinobutiophenone (α-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
Cyprenorphine 9054 I
Desomorphine 9055 I
Etorphine (except HCl) 9056 I
Codeine methylbromide 9070 I
Dihydromorphine 9145 I
Difenoxin 9168 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
Myrophine 9308 I
Nicocodeine 9309 I
Nicomorphine 9312 I
Normorphine 9313 I
Pholcodine 9314 I
Thebacon 9315 I
Acetorphine 9319 I
Drotebanol 9335 I
Acetylmethadol 9601 I
Allylprodine 9602 I
Alphacetylmethadol except levo-alphacetylmethadol 9603 I
Alphameprodine 9604 I
Alphamethadol 9605 I
Benzethidine 9606 I
Betacetylmethadol 9607 I
Betameprodine 9608 I
Betamethadol 9609 I
Betaprodine 9611 I
Clonitazene 9612 I
Dextromoramide 9613 I
Diampromide 9615 I
Diethylthiambutene 9616 I
Dimenoxadol 9617 I
Dimepheptanol 9618 I
Dimethylthiambutene 9619 I
Dioxaphetyl butyrate 9621 I
Dipipanone 9622 I
Ethylmethylthiambutene 9623 I
Etonitazene 9624 I
Etoxeridine 9625 I
Furethidine 9626 I
Hydroxypethidine 9627 I
Ketobemidone 9628 I
Levomoramide 9629 I
Levophenacylmorphan 9631 I
Morpheridine 9632 I
Noracymethadol 9633 I
Norlevorphanol 9634 I
Normethadone 9635 I
Norpipanone 9636 I
Phenadoxone 9637 I
Phenampromide 9638 I
Phenoperidine 9641 I
Piritramide 9642 I
Proheptazine 9643 I
Properidine 9644 I
Racemoramide 9645 I
Trimeperidine 9646 I
Phenomorphan 9647 I
Propiram 9649 I
1-Methyl-4-phenyl-4-propionoxypiperidine 9661 I
1-(2-Phenylethyl)-4-phenyl-4-acetoxypiperidine 9663 I
Tilidine 9750 I
Para-Fluorofentanyl 9812 I
3-Methylfentanyl 9813 I
Alpha-methylfentanyl 9814 I
Acetyl-alpha-methylfentanyl 9815 I
Acetyl Fentanyl (N-(1-phenethylpiperidin-4-yl)-N-phenylacetamide) 9821 I
Butyryl Fentanyl 9822 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
4-Anilino-N-phenethyl-4-piperidine (ANPP) 8333 II
Phenylacetone 8501 II
1-Piperidinocyclohexanecarbonitrile 8603 II
Alphaprodine 9010 II
Anileridine 9020 II
Coca Leaves 9040 II
Cocaine 9041 II
Codeine 9050 II
Etorphine HCl 9059 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
Metopon 9260 II
Dextropropoxyphene, bulk (non-dosage forms) 9273 II
Morphine 9300 II
Oripavine 9330 II
Thebaine 9333 II
Dihydroetorphine 9334 II
Opium, raw 9600 II
Opium extracts 9610 II
Opium fluid extract 9620 II
Opium tincture 9630 II
Opium, powdered 9639 II
Opium, granulated 9640 II
Levo-alphacetylmethadol 9648 II
Opium poppy 9650 II
Oxymorphone 9652 II
Noroxymorphone 9668 II
Poppy Straw Concentrate 9670 II
Phenazocine 9715 II
Piminodine 9730 II
Racemethorphan 9732 II
Racemorphan 9733 II
Alfentanil 9737 II
Remifentanil 9739 II
Sufentanil 9740 II
Carfentanil 9743 II
Tapentadol 9780 II
Bezitramide 9800 II
Fentanyl 9801 II
Moramide-intermediate 9802 II

The company plans to import small quantities of the listed controlled substances for the National Institute on Drug Abuse (NIDA) for research activities. The company plans to import analytical reference standards for distribution to its customers for research and analytical purposes.

Dated: January 2, 2019.

John J. Martin,

Assistant Administrator.

[FR Doc. 2019-01523 Filed 2-6-19; 8:45 am]

BILLING CODE 4410-09-P