2014-16161. Importer of Controlled Substances Application: Research Triangle Institute

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 1301.34(a) on or before August 11, 2014. Such persons may also file a written request for a hearing on the application pursuant to 21 CFR 1301.43 on or before August 11, 2014.

ADDRESSES:

Written comments should be sent to: Drug Enforcement Administration, Attention: DEA Federal Register Representative/ODW, 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, and dispensers 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 sec. 7(g) of 28 CFR part 0, subpart R, App.

In accordance with 21 CFR 1301.34(a), this is notice that on April 8, 2014, Research Triangle Institute, Kenneth S. Rehder, Ph.D., Hermann Building East Institute Drive, P.O. Box 12194, Research Triangle Park, North Carolina 27709, applied to be registered as an importer of the following basic classes of controlled substances:

Controlled substance	Schedule
AM-2201 (7201)	I
AM-694 (7694)	I
JWH-018 (7118)	I
JWH-073 (7173)	I
JWH-200 (7200)	I
JWH-250 (6250)	I
JWH-019 (7019)	I
JWH-081 (7081)	I
SR-19 and RCS-4 (7104)	I
JWH-122 (7122)	I
JWH-203 (7203)	I
JWH-398 (7398)	I
1-(1-Phenylcyclohexyl)pyrrolidine (7458)	I
1-[1-(2-Thienyl)cyclohexyl]piperidine (7470)	I
1-[1-(2-Thienyl)cyclohexyl]pyrrolidine (7473)	I
1-Methyl-4-phenyl-4-propionoxypiperidine (9661)	I
1-(2-Phenylethyl)-4-phenyl-4-acetoxypiperidine (9663)	I
2-(4-chloro-2,5-dimethoxyphenyl)-N-(2-methoxybenzl) ethanamine (25C-NBOMe) (7537)	I
2-(4-iodo-2,5-dimethoxyphenyl)-N-(2-methoxybenzl) ethanamine (25I-NBOMe) (7538)	I
2,5-Dimethoxy-4-ethylamphetamine (7399)	I
2,5-Dimethoxyamphetamine (7396)	I
2C-D (7508)	I
2C-E (7509)	I
2C-H (7517)	I
2C-N (7521)	I
2C-P (7524)	I
2C-T-2 (7385)	I
2C-T-7 (7348)	I
2C-I (7518)	I
2C-C (7519)	I
2C-T-4 (7532)	I
3,4,5-Trimethoxyamphetamine (7390)	I
3,4-Methylenedioxyamphetamine (7400)	I
3,4-Methylenedioxymethamphetamine (7405)	I
3,4-Methylenedioxy-N-ethylamphetamine (7404)	I
3-Fluoro-N-methylcathinone (3-FMC) (1233)	I
3-Methylfentanyl (9813)	I
3-Methylthiofentanyl (9833)	I
4-Bromo-2,5-dimethoxyamphetamine (7391)	I
4-Bromo-2,5-dimethoxyphenethylamine (7392)	I
4-Fluoro-N-methylcathinone (4-FMC) (1238)	I
4-Methyl-2,5-dimethoxyamphetamine (7395)	I
4-Methyl-alphapyrrolidinopropiophenone (4-MePPP) (7498)	I
4-Methylaminorex (cis isomer) (1590)	I
4-Methyl-N-ethylcathinone (4-MEC) (1249)	I
4-Methoxyamphetamine (7411)	I
CP-47, 497 C8-homolog (7298)	I
5-Fluoro-PB-22; 5F-PB-22 (7225)	I
5-Methoxy-3,4-methylenedioxyamphetamine (7401)	I
5-Methoxy-N-N-dimethyltryptamine (7431)	I
5-Methoxy-N,N-diisopropyltryptamine (7439)	I
AB-FUBINACA (7012)	I
Acetorphine (9319)	I
Acetyl-alpha-methylfentanyl (9815)	I
Acetyldihydrocodeine (9051)	I
Acetylmethadol (9601)	I
ADB-PINACA (7035)	I
Allylprodine (9602)	I
Alphacetylmethadol except levo-alphacetylmethadol (9603)	I
Alpha-ethyltryptamine (7249)	I
Alphameprodine (9604)	I
Alphamethadol (9605)	I
Alpha-methylfentanyl (9814)	I
Alpha-methylthiofentanyl (9832)	I
Alpha-methyltryptamine (7432)	I
alpha-pyrrolidinopentiophenone (α-PVP) (7545)	I
alpha-pyrrolidinopentiophenone (α-PBP) (7546)	I
Aminorex (1585)	I
APINACA and AKB48 (7048)	I
Benzethidine (9606)	I
Benzylmorphine (9052)	I
Betacetylmethadol (9607)	I
Beta-hydroxy-3-methylfentanyl (9831)	I
Beta-hydroxyfentanyl (9830)	I
Betameprodine (9608)	I
Betamethadol (9609)	I
Betaprodine (9611)	I
Bufotenine (7433)	I
Butylone (7541)	I
CP-47, 497 (7297)	I
Cathinone (1235)	I
Clonitazene (9612)	I
Codeine methylbromide (9070)	I
Codeine-N-Oxide (9053)	I
Cyprenorphine (9054)	I
Desomorphine (9055)	I
Dextromoramide (9613)	I
Diampromide (9615)	I
Diethylthiambutene (9616)	I
Diethyltryptamine (7434)	I
Difenoxin (9168)	I
Dihydromorphine (9145)	I
Dimenoxadol (9617)	I
Dimepheptanol (9618)	I
Dimethylthiambutene (9619)	I
Dimethyltryptamine (7435)	I
Dioxaphetyl butyrate (9621)	I
Dipipanone (9622)	I
Drotebanol (9335)	I
Ethylmethylthiambutene (9623)	I
Etonitazene (9624)	I
Etorphine HCl (9056)	I
Etoxeridine (9625)	I
Fenethylline (1503)	I
Furethidine (9626)	I
Heroin (9200)	I
Hydromorphinol (9301)	I
Hydroxypethidine (9627)	I
Gamma Hydroxybutyric Acid (2010)	I
Ibogaine (7260)	I
Ketobemidone (9628)	I
Levomoramide (9629)	I
Levophenacylmorphan (9631)	I
Lysergic acid diethylamide (7315)	I
MDPV (7535)	I
Marihuana (7360)	I
Mecloqualone (2572)	I
Mephedrone (1248)	I
Mescaline (7381)	I
Methaqualone (2565)	I
Methcathinone (1237)	I
Methyldesorphine (9302)	I
Methyldihydromorphine (9304)	I
Methylone (7540)	I
Morpheridine (9632)	I
Morphine methylbromide (9305)	I
Morphine methylsulfonate (9306)	I
Morphine-N-Oxide (9307)	I
Myrophine (9308)	I
N,N-Dimethylamphetamine (1480)	I
N-Benzylpiperazine (7493)	I
N-Ethyl-3-piperidyl benzilate (7482)	I
N-Ethylamphetamine (1475)	I
N-Ethyl-1-phenylcyclohexylamine (7455)	I
N-Hydroxy-3,4-methylenedioxyamphetamine (7402)	I
Naphyrone (1258)	I
Nicocodeine (9309)	I
Nicomorphine (9312)	I
N-Methyl-3-piperidyl benzilate (7484)	I
Noracymethadol (9633)	I
Norlevorphanol (9634)	I
Normethadone (9635)	I
Normorphine (9313)	I
Norpipanone (9636)	I
Para-Fluorofentanyl (9812)	I
Parahexyl (7374)	I
Pentedrone (α-methylaminovalerophenone) (1246)	I
Pentylone (7542)	I
Peyote (7415)	I
Phenadoxone (9637)	I
Phenampromide (9638)	I
Phenomorphan (9647)	I
Phenoperidine (9641)	I
Pholcodine (9314)	I
Piritramide (9642)	I
Proheptazine (9643)	I
Properidine (9644)	I
Propiram (9649)	I
Psilocybin (7437)	I
Psilocyn (7438)	I
PB-22 (7222)	I
Racemoramide (9645)	I
SR-18 and RCS-8 (7008)	I
Tetrahydrocannabinols (7370)	I
Thebacon (9315)	I
Thiofentanyl (9835)	I
Tilidine (9750)	I
Trimeperidine (9646)	I
UR-144 (7144)	I
1-Phenylcyclohexylamine (7460)	II
1-Piperidinocyclohexanecarbonitrile (8603)	II
4-Anilino-N-phenethyl-4-piperidine (8333)	II
Alfentanil (9737)	II
Alphaprodine (9010)	II
Amobarbital (2125)	II
Amphetamine (1100)	II
Anileridine (9020)	II
Bezitramide (9800)	II
Carfentanil (9743)	II
Coca Leaves (9040)	II
Cocaine (9041)	II
Codeine (9050)	II
Dextropropoxyphene, bulk (non-dosage forms) (9273)	II
Dihydrocodeine (9120)	II
Dihydroetorphine (9334)	II
Diphenoxylate (9170)	II
Ecgonine (9180)	II
Ethylmorphine (9190)	II
Etorphine HCl (9059)	II
Fentanyl (9801)	II
Glutethimide (2550)	II
Hydrocodone (9193)	II
Hydromorphone (9150)	II
Isomethadone (9226)	II
Levo-alphacetylmethadol (9648)	II
Levomethorphan (9210)	II
Levorphanol (9220)	II
Lisdexamfetamine (1205)	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
Methamphetamine (1105)	II
Methylphenidate (1724)	II
Metopon (9260)	II
Moramide intermediate (9802)	II
Morphine (9300)	II
Nabilone (7379)	II
Noroxymorphone (9668)	II
Opium, raw (9600)	II
Opium extracts (9610)	II
Opium fluid (9620)	II
Opium tincture (9630)	II
Opium poppy/Poppy Straw (9650)	II
Oripavine (9330)	II
Poppy Straw Concentrate (9670)	II
Opium, granulated (9640)	II
Oxycodone (9143)	II
Oxymorphone (9652)	II
Pentobarbital (2270)	II
Phenazocine (9715)	II
Phencyclidine (7471)	II
Phenmetrazine (1631)	II
Phenylacetone (8501)	II
Piminodine (9730)	II
Opium, powdered (9639)	II
Racemethorphan (9732)	II
Racemorphan (9733)	II
Remifentanil (9739)	II
Secobarbital (2315)	II
Sufentanil (9740)	II
Tapentadol (9780)	II
Thebaine (9333)	II

The company plans to import small quantities of the listed controlled substances for the National Institute on Drug Abuse for research activities.

In reference to drug codes 7360 and 7370, the company plans to import a synthetic cannabidiol and a synthetic tetrahydrocannabinol. No other activity for this drug code is authorized for this registration.

Comments and requests for hearings on applications to import narcotic raw material are not appropriate. 72 FR 3417 (January 25, 2007).

In regard to the non-narcotic raw material, any bulk manufacturer who is presently, or is applying to be, registered with the DEA to manufacture such basic classes of controlled substances listed in schedules I or II, which fall under the authority of section 1002(a)(2)(B) of the Act (21 U.S.C. 952(a)(2)(B)) may, in the circumstances set forth in 21 U.S.C. 958(i), file comments or objections to the issuance of the proposed registration and may, at the same time, file a written request for a hearing on such application pursuant to 21 CFR 1301.43 and in such form as prescribed by 21 CFR 1316.47.

Dated: July 2, 2014.

Joseph T. Rannazzisi,

Deputy Assistant Administrator.