80 FR 46330 - Importer of Controlled Substances Application: Research Triangle Institute

DEPARTMENT OF JUSTICE
Drug Enforcement Administration

Federal Register Volume 80, Issue 149 (August 4, 2015)

[Federal Register Volume 80, Number 149 (Tuesday, August 4, 2015)]
[Notices]
[Pages 46330-46334]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2015-19158]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. DEA-392]


Importer of Controlled Substances Application: Research Triangle 
Institute

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 in accordance with 21 CFR 
1301.34(a) on or before September 3, 2015. Such persons may also file a 
written request for a hearing on the application pursuant to 21 CFR 
1301.43 on or before September 3, 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. 
Comments and requests for hearings on applications to import narcotic 
raw material are not appropriate. 72 FR 3417 (January 25, 2007).

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 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 1301.34(a), this is notice that on March 
12, 2015, Research Triangle Institute, Kenneth S. Rehder, Hermann 
Building East Institute Drive, P.O. Box 12194, Research Triangle Park, 
North Carolina 27709-2194 applied to be registered as an importer of 
the following basic classes of controlled substances:

------------------------------------------------------------------------
            Controlled substance                       Schedule
------------------------------------------------------------------------
AB-PINACA (N-(1-amino-3-methyl-1-oxobutan-2-  I
 yl)-1-pentyl-1-1H-indazole-3-carboxamide)
 (7023).
AB-CHMINACA (N-(1-amino-3-methyl-1-oxobutan-  I
 2-yl)-1-(cyclohexylmethyl)-1H-indazole-3-
 carboxamide (7031).
AM-2201 (1-(5-Fluoropentyl)-3-(1-             I
 naphthoyl)indole) (7201).
AM-694 (1-(5-Fluoropentyl)-3-(2-iodobenzoyl)  I
 indole) (7694).
JWH-018 (also known as AM678) (1-Pentyl-3-(1- I
 naphthoyl) indole) (7118).
JWH-073 (1-Butyl-3-(1-naphthoyl)indole)       I
 (7173).

[[Page 46331]]

 
JWH-200 (1-[2-(4-Morpholinyl)ethyl]-3-(1-     I
 naphthoyl)indole) (7200).
JWH-250 (1-Pentyl-3-(2-methoxyphenylacetyl)   I
 indole) (6250).
JWH-019 (1-Hexyl-3-(1-naphthoyl)indole)       I
 (7019).
JWH-081 (1-Pentyl-3-(1-(4-methoxynaphthoyl)   I
 indole) (7081).
JWH-122 (-Pentyl-3-(4-methyl-1-naphthoyl)     I
 indole) (7122).
JWH-203 (1-Pentyl-3-(2-chlorophenylacetyl)    I
 indole) (7203).
JWH-398 (1-Pentyl-3-(4-chloro-1-naphththoyl)  I
 indole) (7398).
THJ-2201 [1-(5-fluoropentyl)-1H-indazol-3-    I
 yl](naphthalene-1-yl)methanone (7024).
1-(1-Phenylcyclohexyl)pyrrolidine (7458)....  I
1-[1-(2-Thienyl)cyclohexyl]piperidine (7470)  I
1-[1-(2-Thienyl)cyclohexyl]pyrrolidine        I
 (7473).
1-Methyl-4-phenyl-4-propionoxypiperidine      I
 (9661).
1-(2-Phenylethyl)-4-phenyl-4-                 I
 acetoxypiperidine (9663).
2,5-Dimethoxy-4-(n)-propylthiophenethylamine  I
 (2C-T-7) (7348).
2,5-Dimethoxy-4-ethylamphetamine (7399).....  I
2,5-Dimethoxyamphetamine (7396).............  I
2-(2,5-Dimethoxy-4-methylphenyl) ethanamine   I
 (2C-D) (7508).
2-(2,5-Dimethoxy-4-ethylphenyl) ethanamine    I
 (2C-E) (7509).
2-(2,5-Dimethoxyphenyl) ethanamine (2C-H)     I
 (7517).
2-(2,5-Dimethoxy-4-nitro-phenyl) ethanamine   I
 (2C-N) (7521).
2-(2,5-Dimethoxy-4-(n)-propylphenyl)          I
 ethanamine (2C-P) (7524).
2-(4-isopropylthio)-2,5-dimethoxyphenyl)      I
 ethanamine (2C-T-4) (7532).
2-(4-bromo-2,5-dimethoxyphenyl)-N-(2-         I
 methoxybenzyl)ethanamine (25B-NBOMe) (7536).
2,5-Dimethoxy-4-(n)-propylthiophenethylamine  I
 (2C-T-7) (7348).
2-(4-Ethylthio-2,5-dimethoxyphenyl)           I
 ethanamine (2C-T-2) (7385).
2-(4-Lodo-2,5-dimethoxyphenyl) ethanamine     I
 (2C-I) (7518).
2-(4-Chloro-2,5-dimethoxyphenyl) ethanamine   I
 (2C-C) (7519).
3,4,5-Trimethoxyamphetamine (7390)..........  I
3,4-Methylenedioxyamphetamine (7400)........  I
3,4-Methylenedioxy-N-ethylamphetamine (7404)  I
3,4-Methylenedioxymethamphetamine (7405)....  I
3-Methylfentanyl (9813).....................  I
3-Methylthiofentanyl (9833).................  I
4-Bromo-2,5-dimethoxyamphetamine (7391).....  I
4-Bromo-2,5-dimethoxyphenethylamine (7392)..  I
4-Methyl-2,5-dimethoxyamphetamine (7395)....  I
4-Methylaminorex (cis isomer) (1590)........  I
4-Methoxyamphetamine (7411).................  I
5-Methoxy-3,4-methylenedioxyamphetamine       I
 (7401).
5-Methoxy-N,N-dimethyltryptamine (7431).....  I
5-Methoxy-N,N-diisopropyltryptamine (7439)..  I
Acetorphine (9319)..........................  I
Acetyl-alpha-methylfentanyl (9815)..........  I
Acetyldihydrocodeine (9051).................  I
Acetylmethadol (9601).......................  I
Allylprodine (9602).........................  I
Alpha-ethyltryptamine (7249)................  I
Alpha-methylfentanyl (9814).................  I
Alpha-methylthiofentanyl (9832).............  I
Alpha-methyltryptamine (7432)...............  I
Alphacetylmethadol except levo-               I
 alphacetylmethadol (9603).
Alphameprodine (9604).......................  I
Alphamethadol (9605)........................  I
Aminorex (1585).............................  I
Benzethidine (9606).........................  I
Benzylmorphine (9052).......................  I
Beta-hydroxy-3-methylfentanyl (9831)........  I
Beta-hydroxyfentanyl (9830).................  I
Betacetylmethadol (9607)....................  I
Betameprodine (9608)........................  I
Betamethadol (9609).........................  I
Betaprodine (9611)..........................  I
Bufotenine (7433)...........................  I
CP-47,497 (5-(1,1-Dimethylheptyl)-2-[(1R,3S)- I
 3-hydroxycyclohexyl-phenol) (7297).
CP-47,497 C8 Homologue (5-(1,1-               I
 Dimethyloctyl)-2-[(1R,3S)3-
 hydroxycyclohexyl-phenol) (7298).
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

[[Page 46332]]

 
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 (except HCl) (9056)...............  I
Etoxeridine (9625)..........................  I
Fenethylline (1503).........................  I
Furethidine (9626)..........................  I
Gamma Hydroxybutyric Acid (2010)............  I
Heroin (9200)...............................  I
Hydromorphinol (9301).......................  I
Hydroxypethidine (9627).....................  I
Ibogaine (7260).............................  I
Ketobemidone (9628).........................  I
Levomoramide (9629).........................  I
Levophenacylmorphan (9631)..................  I
Lysergic acid diethylamide (7315)...........  I
MDPV (3,4-Methylenedioxypyrovalerone) (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 (3,4-Methylenedioxy-N-              I
 methylcathinone) (7540).
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) N-Ethyl-1-          I
 phenylcyclohexylamine (7455).
N-Hydroxy-3,4-methylenedioxyamphetamine       I
 (7402).
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
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
Racemoramide (9645).........................  I
SR-18 (Also known as RCS-8) (1-               I
 Cyclohexylethyl-3-(2-methoxyphenylacetyl)
 indole) (7008).
SR-19 (Also known as RCS-4) (1-Pentyl-3-[(4-  I
 methoxy)-benzoyl] indole (7104).
Tetrahydrocannabinols (7370)................  I
Thebacon (9315).............................  I
Thiofentanyl (9835).........................  I
Tilidine (9750).............................  I

[[Page 46333]]

 
Trimeperidine (9646)........................  I
1-Phenylcyclohexylamine (7460)..............  II
1-Piperidinocyclohexanecarbonitrile (8603)..  II
4-Anilino-N-phenethyl-4-piperidine (ANPP)     II
 (8333).
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)   II
 (9273).
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
Opium, raw (9600)...........................  II
Opium extracts (9610).......................  II
Opium fluid extract (9620)..................  II
Opium tincture (9630).......................  II
Opium powdered (9639).......................  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
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 (NIDA) 
for research activities.
    The company plans to import analytical reference standards for 
distribution to its customers for research

[[Page 46334]]

and analytical purposes. Placement of these drug codes onto the 
company's registration does not translate into automatic approval of 
subsequent permit applications to import controlled substances. 
Approval of permit applications will occur only when the registrant's 
business activity is consistent with what is authorized under to 21 
U.S.C. 952(a)(2). Authorization will not extend to the import of FDA 
approved or non-approved finished dosage forms for commercial sale.

    Dated: July 29, 2015.
Joseph T. Rannazzisi,
Deputy Assistant Administrator.
[FR Doc. 2015-19158 Filed 8-3-15; 8:45 am]
BILLING CODE 4410-09-P