Importer of Controlled Substances Application: Research Triangle Institute, 10466-10470 [2020-03619]

Agencies

• Drug Enforcement Administration
• Department of Justice

[Federal Register Volume 85, Number 36 (Monday, February 24, 2020)]
[Notices]
[Pages 10466-10470]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-03619]


-----------------------------------------------------------------------

DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. DEA-586]


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 on or before March 25, 2020. Such 
persons may also file a written request for a hearing on the 
application on or before March 25, 2020.

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 a 
hearing must be sent to: Drug Enforcement Administration, Attn: 
Administrator, 8701 Morrissette Drive, Springfield, Virginia 22152. All 
request for a 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,

[[Page 10467]]

Attn: DEA Federal Register Representative/DPW, 8701 Morrissette Drive, 
Springfield, Virginia 22152.

SUPPLEMENTARY INFORMATION: In accordance with 21 CFR 1301.34(a), this 
is notice that on December 06, 2019, Research Triangle Institute, 3040 
East Cornwallis Road, Herman Building--Room 106, Research Triangle 
Park, North Carolina 27709-2194 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 ([alpha]-                           1246  I
 methylaminovalerophenone).
Mephedrone (4-Methyl-N-                        1248  I
 methylcathinone).
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-                  7010  I
 dimethyl-1-oxobutan-2-yl)-1-(4-
 fluorobenzyl)-1H-indazole-3-
 carboxamide).
5-Fluoro-UR-144 and XLR11 [1-(5-               7011  I
 Fluoro-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).
FUB-144 (1-(4-Fluorobenzyl)-1H-                7014  I
 indol-3-yl)(2,2,3,3-
 tetramethylcyclopropyl)methanone).
JWH-019 (1-Hexyl-3-(1-                         7019  I
 naphthoyl)indole).
MDMB-FUBINACA (Methyl 2-(1-(4-                 7020  I
 fluorobenzyl)-1H-indazole-3-
 carboxamido)-3,3-
 dimethylbutanoate).
FUB-AMB, MMB-FUBINACA, AMB-FUBINACA            7021  I
 Methyl (2-(1-(4-fluorobenzyl)-
 1Hindazole-3-carboxamido)-3-
 methylbutanoate).
AB-PINACA (N-(1-amino-3-methyl-1-              7023  I
 oxobutan-2-yl)-1-pentyl-1H-
 indazole3-carboxamide).
THJ-2201 [1-(5-fluoropentyl)-1H-               7024  I
 indazol-3-yl](naphthalen-1-
 yl)methanone.
5F-AB-PINACA (N-(1-amino-3-methyl-1-           7025  I
 oxobutan-2-yl)-1-(5-fluropentyl)-
 1H-indazole-3-carboximide).
AB-CHMINACA (N-(1-amino-3-methyl-1-            7031  I
 oxobutan-2-yl)-1-
 (cyclohexylmethyl)1H-indazole-3-
 carboxamide.
MAB-CHMINACA (N-(1-amino-                      7032  I
 3,3dimethyl-1-oxobutan-2-yl)-1-
 (cyclohexylmethyl)-1H-indazole-3-
 carboxamide).
5F-AMB (Methyl 2-(1-(5-                        7033  I
 fluoropentyl)-1H-indazole-3-
 carboxamido)-3-methylbutanoate).
5F-ADB, 5F-MDMB-PINACA (Methyl 2-(1-           7034  I
 (5-fluoropentyl)-1H-indazole-3-
 carboxamido)-3,3-
 dimethylbutanoate).
ADB-PINACA (N-(1-amino-3,3-dimethyl-           7035  I
 1-oxobutan-2-yl)-1-pentyl-1H-
 indazole-3-carboxamide).
5F-EDMB-PINACA (Ethyl 2-(1-(5-                 7036  I
 fluoropentyl)-1H-indazole-3-
 carboxamido)-3,3-
 dimethylbutanoate).
5F-MDMB-PICA (Methyl 2-(1-(5-                  7041  I
 fluoropentyl)-1H-indole-3-
 carboxamido)-3,3-
 dimethylbutanoate).
MDMB-CHMICA, MMB-CHMINACA (Methyl 2-           7042  I
 (1-(cyclohexylmethyl)-1H-indole-3-
 carboxamido)-3,3-
 dimethylbutanoate).
MMB-CHMICA, AMB-CHMICA (methyl 2-(1-           7044  I
 (cyclohexylmethyl)-1H-indole-3-
 carboxamido)-3-methylbutanoate).
FUB-AKB48, FUB-APINACA, AKB48 N-(4-            7047  I
 FLUOROBENZYL) (N-(adamantan-1-yl)-
 1-(4-fluorobenzyl)-1H-indazole-3-
 carboximide).
APINACA and AKB48 N-(1-Adamantyl)-1-           7048  I
 pentyl-1H-indazole-3-carboxamide.
5F-APINACA, 5F-AKB48 (N-(adamantan-            7049  I
 1-yl)-1-(5-fluoropentyl)-1H-
 indazole-3-carboxamide).
JWH-081 (1-Pentyl-3-(1-(4-                     7081  I
 methoxynaphthoyl) indole).
5F-CUMYL-PINACA, SGT-25 (1-(5-                 7083  I
 fluoropentyl)-N-(2-phenylpropan-2-
 yl)-1H-indazole-3-carboxamide).
5F-CUMYL-P7AICA (1-(5-fluoropentyl)-           7085  I
 N-(2-phenylpropan-2-yl)-1H-
 pyrrolo[2,3-b]pyridine-3-
 carboxamide).
4-CN-CUML-BUTINACA, 4-cyano-CUMYL-             7089  I
 BUTINACA, 4-CN-CUMYL BINACA, CUMYL-
 4CN-BINACA, SGT-78 (1-(4-
 cyanobutyl)-N-(2-phenylpropan-2-
 yl)-1H-indazole-3-carboxamide).
SR-19 (Also known as RCS-4) (1-                7104  I
 Pentyl-3-[(4-methoxy)-benzoyl]
 indole.
JWH-018 (also known as AM678) (1-              7118  I
 Pentyl-3-(1-naphthoyl)indole).
JWH-122 (1-Pentyl-3-(4-methyl-1-               7122  I
 naphthoyl) indole).
UR-144 (1-Pentyl-1H-indol-3-                   7144  I
 yl)(2,2,3,3-
 tetramethylcyclopropyl)methanone.
JWH-073 (1-Butyl-3-(1-                         7173  I
 naphthoyl)indole).
JWH-200 (1-[2-(4-Morpholinyl)ethyl]-           7200  I
 3-(1-naphthoyl)indole).
AM2201 (1-(5-Fluoropentyl)-3-(1-               7201  I
 naphthoyl) indole).
JWH-203 (1-Pentyl-3-(2-                        7203  I
 chlorophenylacetyl) indole).
NM2201, CBL2201 (Naphthalen-1-yl 1-            7221  I
 (5-fluoropentyl)-1H-indole-3-
 carboxylate.
PB-22 (Quinolin-8-yl 1-pentyl-1H-              7222  I
 indole-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 Extract..................            7350  I
Parahexyl..........................            7374  I
Mescaline..........................            7381  I

[[Page 10468]]

 
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-                                 7401  I
 methylenedioxyamphetamine.
N-Hydroxy-3,4-                                 7402  I
 methylenedioxyamphetamine.
3,4-Methylenedioxy-N-                          7404  I
 ethylamphetamine.
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-                                       7470  I
 Thienyl)cyclohexyl]piperidine.
1-[1-(2-                                       7473  I
 Thienyl)cyclohexyl]pyrrolidine.
N-Ethyl-3-piperidyl benzilate......            7482  I
N-Methyl-3-piperidyl benzilate.....            7484  I
N-Benzylpiperazine.................            7493  I
4-Methyl-                                      7498  I
 alphapyrrolidinopropiophenone (4-
 MePPP).
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             7517  I
 (2C-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)-                        7524  I
 propylphenyl) ethanamine (2C-P).
2-(4-Isopropylthio)-2,5-                       7532  I
 dimethoxyphenyl) ethanamine (2C-T-
 4 ).
MDPV (3,4-                                     7535  I
 Methylenedioxypyrovalerone).
2-(4-bromo-2,5-dimethoxyphenyl)-N-             7536  I
 (2-methoxybenzyl) ethanamine (25B-
 NBOMe).
2-(4-chloro-2,5-dimethoxyphenyl)-N-            7537  I
 (2-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
N-Ethypentylone, ephylone (1-(1,3-             7543  I
 benzodioxol-5-yl)-2-(ethylamino)-
 pentan-1-one).
alpha-pyrrolidinopentiophenone                 7545  I
 ([alpha]-PVP).
alpha-pyrrolidinobutiophenone                  7546  I
 ([alpha]-PBP).
AM-694 (1-(5-Fluoropentyl)-3-(2-               7694  I
 iodobenzoyl) indole).
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

[[Page 10469]]

 
U-47700 (3,4-dichloro-N-[2-                    9547  I
 (dimethylamino)cyclohexyl]-N-
 methylbenzamide).
AH-7921 (3,4-dichloro-N-[(1-                   9551  I
 dimethylamino)cyclohexylmethyl]ben
 zamide)).
MT-45 (1-cyclohexyl-4-(1,2-                    9560  I
 diphenylethyl)piperazine)).
Acetylmethadol.....................            9601  I
Allylprodine.......................            9602  I
Alphacetylmethadol except levo-                9603  I
 alphacetylmethadol.
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-                           9661  I
 propionoxypiperidine.
1-(2-Phenylethyl)-4-phenyl-4-                  9663  I
 acetoxypiperidine.
Tilidine...........................            9750  I
Acryl fentanyl (N-(1-                          9811  I
 phenethylpiperidin-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-                         9821  I
 phenethylpiperidin-4-yl)-N-
 phenylacetamide).
Butyryl Fentanyl...................            9822  I
Para-fluorobutyryl fentanyl........            9823  I
4-Fluoroisobutyryl fentanyl (N-(4-             9824  I
 fluorophenyl)-N-(1-
 phenethylpiperidin-4-
 yl)isobutyramide).
2-methoxy-N-(1-phenethylpiperidin-4-           9825  I
 yl)-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

[[Page 10470]]

 
Fentanyl related-compounds as                  9850  I
 defined in 21 CFR 1308.11(h).
Phenmetrazine......................            1631  II
Methylphenidate....................            1724  II
Amobarbital........................            2125  II
Pentobarbital......................            2270  II
Secobarbital.......................            2315  II
Glutethimide.......................            2550  II
Dronabinol in an oral solution in a            7365  II
 drug product approved for
 marketing by the U.S. Food and
 Drug Administration.
Nabilone...........................            7379  II
1-Phenylcyclohexylamine............            7460  II
Phencyclidine......................            7471  II
4-Anilino-N-phenethyl-4-piperidine             8333  II
 (ANPP).
Phenylacetone......................            8501  II
1-Piperidinocyclohexanecarbonitrile            8603  II
Alphaprodine.......................            9010  II
Anileridine........................            9020  II
Coca Leaves........................            9040  II
Cocaine............................            9041  II
Etorphine HCl......................            9059  II
Dihydrocodeine.....................            9120  II
Diphenoxylate......................            9170  II
Ecgonine...........................            9180  II
Ethylmorphine......................            9190  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
Metopon............................            9260  II
Dextropropoxyphene, bulk (non-                 9273  II
 dosage forms).
Dihydroetorphine...................            9334  II
Opium tincture.....................            9630  II
Opium, powdered....................            9639  II
Opium, granulated..................            9640  II
Phenazocine........................            9715  II
Thiafentanil.......................            9729  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
Moramide-intermediate..............            9802  II
------------------------------------------------------------------------

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

    Dated: February 6, 2020.
William T. McDermott,
Assistant Administrator.
[FR Doc. 2020-03619 Filed 2-21-20; 8:45 am]
BILLING CODE 4410-09-P