[Federal Register Volume 86, Number 75 (Wednesday, April 21, 2021)]
[Notices]
[Pages 20734-20738]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-08166]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. DEA-816]


Importer of Controlled Substances Application: Research Triangle 
Institute

AGENCY: Drug Enforcement Administration, Department of Justice.

ACTION: Notice of application.

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

SUMMARY: Research Triangle Institute has applied to be registered as an 
importer of basic class(es) of controlled substance(s). Refer to 
Supplementary Information listed below for further drug information.

DATES: Registered bulk manufacturers of the affected basic class(es), 
and applicants therefore, may file written comments on or objections to 
the issuance of the proposed registration on or before May 21, 2021. 
Such persons may also file a written request for a hearing on the 
application on or before May 21, 2021.

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 
requests 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, 
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 March 18, 2021, Research Triangle Institute, 3040 
East Cornwallis Road, Hermann Building, Room 106, Research Triangle 
Park, North Carolina 22709-0000, applied to be registered as an 
importer of the following basic class(es) of controlled substance(s):

------------------------------------------------------------------------
            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-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)        6250  I
 indole).
SR-18 (Also known as RCS-8) (1-                    7008  I
 Cyclohexylethyl-3-(2-methoxyphenylacetyl)
 indole).
ADB-FUBINACA (N-(1-amino-3,3-dimethyl-1-           7010  I
 oxobutan-2-yl)-1-(4-fluorobenzyl)-1H-
 indazole-3-carboxamide).
5-Fluoro-UR-144 and XLR11 [1-(5-Fluoro-            7011  I
 pentyl)1H-indol-3-yl](2,2,3,3-
 tetramethylcyclopropyl)methanone.
AB-FUBINACA (N-(1-amino-3-methyl-1-oxobutan-       7012  I
 2-yl)-1-(4-fluorobenzyl)-1H-indazole-3-
 carboxamide).
FUB-144 (1-(4-fluorobenzyl)-1H-indol-3-            7014  I
 yl)(2,2,3,3-
 tetramethylcyclopropyl)methanone).
JWH-019 (1-Hexyl-3-(1-naphthoyl)indole).....       7019  I
MDMB-FUBINACA (Methyl 2-(1-(4-fluorobenzyl)-       7020  I
 1H-indazole-3-carboxamido)-3,3-
 dimethylbutanoate).

[[Page 20735]]

 
FUB-AMB, MMB- FUBINACA, AMB-FUBINACA (2-(1-        7021  I
 (4-fluorobenzyl)-1Hindazole-3-carboxamido)-
 3-methylbutanoate).
AB-PINACA (N-(1-amino-3-methyl-1-oxobutan-2-       7023  I
 yl)-1-pentyl-1H-indazole-3-carboxamide).
THJ-2201 ([1-(5-fluoropentyl)-1H-indazol-3-        7024  I
 yl](naphthalen-1-yl)methanone).
5F-AB-PINACA (N-(1-amino-3-methyl-1-oxobutan-      7025  I
 2-yl)-1-(5-fluropentyl)-1H-indazole-3-
 carboximide).
AB-CHMINACA (N-(1-amino-3-methyl-1-oxobutan-       7031  I
 2-yl)-1-(cyclohexylmethyl)-1H-indazole-3-
 carboxamide).
MAB-CHMINACA (N-(1-amino-3,3dimethyl-1-            7032  I
 oxobutan-2-yl)-1-(cyclohexylmethyl)-1H-
 indazole-3-carboxamide).
5F-AMB (Methyl 2-(1-(5-fluoropentyl)-1H-           7033  I
 indazole-3-carboxamido)-3-methylbutanoate).
5F-ADB, 5F-MDMB-PINACA (Methyl 2-(1-(5-            7034  I
 fluoropentyl)-1H-indazole-3-carboxamido)-
 3,3-dimethylbutanoate).
ADB-PINACA (N-(1-amino-3,3-dimethyl-1-             7035  I
 oxobutan-2-yl)-1-pentyl-1H-indazole-3-
 carboxamide).
5F-EDMB-PINACA (ethyl 2-(1-(5-fluoropentyl)-       7036  I
 1H-indazole-3-carboxamido)-3,3-
 dimethylbutanoate).
5F-MDMB-PICA (methyl 2-(1-(5-fluoropentyl)-        7041  I
 1H-indole-3-carboxamido)-3,3-
 dimethylbutanoate).
MDMB-CHMICA, MMB-CHMINACA (Methyl 2-(1-            7042  I
 (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-pentyl-       7048  I
 1H-indazole-3-carboxamide).
5F-APINACA, 5F-AKB48 (N-(adamantan-1-yl)-1-        7049  I
 (5-fluoropentyl)-1H-indazole-3-carboxamide).
JWH-081 (1-Pentyl-3-(1-(4-methoxynaphthoyl)        7081  I
 indole).
5F-CUMYL-PINACA, 5GT-25 (1-(5-fluoropentyl)-       7083  I
 N-(2-phenylpropan-2-yl)-1H-indazole-3-
 carboxamide).
5F-CUMYL-P7AICA (1-(5-fluoropentyl)-N-(2-          7085  I
 phenylpropan-2-yl)-1H-pyrrolo[2,3-
 b]pyridine-3-carboxamide).
4-CN-CUML-BUTINACA, 4-cyano-CUMYL-BUTINACA,        7089  I
 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-Pentyl-3-[(4-       7104  I
 methoxy)-benzoyl] indole).
JWH-018 (also known as AM678) (1-Pentyl-3-(1-      7118  I
 naphthoyl)indole).
JWH-122 (1-Pentyl-3-(4-methyl-1-naphthoyl)         7122  I
 indole).
UR-144 (1-Pentyl-1H-indol-3-yl)(2,2,3,3-           7144  I
 tetramethylcyclopropyl)methanone.
JWH-073 (1-Butyl-3-(1-naphthoyl)indole).....       7173  I
JWH-200 (1-[2-(4-Morpholinyl)ethyl]-3-(1-          7200  I
 naphthoyl)indole).
AM2201 (1-(5-Fluoropentyl)-3-(1-naphthoyl)         7201  I
 indole).
JWH-203 (1-Pentyl-3-(2-chlorophenylacetyl)         7203  I
 indole).
NM2201, CBL2201 (Naphthalen-1-yl 1-(5-             7221  I
 fluoropentyl)-1H-indole-3-carboxylate.
PB-22 (Quinolin-8-yl 1-pentyl-1H-indole-3-         7222  I
 carboxylate).
5F-PB-22 (Quinolin-8-yl 1-(5-fluoropentyl)-        7225  I
 1H-indole-3-carboxylate).
4-Methyl-alpha-ethylaminopentiophenone (4-         7245  I
 MEAP).
N-Ethylhexedrone............................       7246  I
Alpha-ethyltryptamine.......................       7249  I
Ibogaine....................................       7260  I
CP-47,497 (5-(1,1-Dimethylheptyl)-2-[(1R,3S)-      7297  I
 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
2C-T-7 (2,5-Dimethoxy-4-(n)-                       7348  I
 propylthiophenethylamine.
Marihuana Extract...........................       7350  I
Parahexyl...................................       7374  I
Mescaline...................................       7381  I
2C-T-2 (2-(4-Ethylthio-2,5-dimethoxyphenyl)        7385  I
 ethanamine ).
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)         7398  I
 indole).
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
4-Chloro-alpha-pyrrolidinovalerophenone (4-        7443  I
 chloro-a-PVP ).
4-Methyl-alpha-pyrrolidinohexiophenone             7446  I
 (MPHP).
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

[[Page 20736]]

 
N-Ethyl-3-piperidyl benzilate...............       7482  I
N-Methyl-3-piperidyl benzilate..............       7484  I
N-Benzylpiperazine..........................       7493  I
4-MePPP (4-Methyl-                                 7498  I
 alphapyrrolidinopropiophenone).
2C-D (2-(2,5-Dimethoxy-4-methylphenyl)             7508  I
 ethanamine).
2C-E (2-(2,5-Dimethoxy-4-ethylphenyl)              7509  I
 ethanamine).
2C-H 2-(2,5-Dimethoxyphenyl) ethanamine)....       7517  I
2C-I 2-(4-iodo-2,5-dimethoxyphenyl)                7518  I
 ethanamine).
2C-C 2-(4-Chloro-2,5-dimethoxyphenyl)              7519  I
 ethanamine).
2C-N (2-(2,5-Dimethoxy-4-nitro-phenyl)             7521  I
 ethanamine).
2C-P (2-(2,5-Dimethoxy-4-(n)-propylphenyl)         7524  I
 ethanamine).
2C-T-4 (2-(4-Isopropylthio)-2,5-                   7532  I
 dimethoxyphenyl) ethanamine).
MDPV (3,4-Methylenedioxypyrovalerone).......       7535  I
25B-NBOMe (2-(4-bromo-2,5-dimethoxyphenyl)-N-      7536  I
 (2-methoxybenzyl) ethanamine).
25C-NBOMe (2-(4-chloro-2,5-dimethoxyphenyl)-       7537  I
 N-(2-methoxybenzyl) ethanamine).
25I-NBOMe (2-(4-iodo-2,5-dimethoxyphenyl)-N-       7538  I
 (2-methoxybenzyl) ethanamine).
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-pyrrolidinohexanophenone (a-PHP)......       7544  I
alpha-pyrrolidinopentiophenone ([alpha]-PVP)       7545  I
alpha-pyrrolidinobutiophenone ([alpha]-PBP).       7546  I
Ethylone....................................       7547  I
Alpha-pyrrolidinoheptaphenone (PV8).........       7548  I
AM-694 (1-(5-Fluoropentyl)-3-(2-iodobenzoyl)       7694  I
 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
Brorphine (1-(1-(1-(4-                             9098  I
 bromophenyl)ethyl)piperidin-4-yl)-1,3-
 dihydro-2H-benzo[d]imidazol-2-one).
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
U-47700 (3,4-dichloro-N-[2-                        9547  I
 (dimethylamino)cyclohexyl]-N-
 methylbenzamide).
AH-7921 (3,4-dichloro-N-[(1-                       9551  I
 dimethylamino)cyclohexylmethyl]benzamide)).
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
Isotonitazene (N,N-diethyl-2-(2-(4                 9614  I
 isopropoxybenzyl)-5-nitro-1H-benzimidazol-1-
 yl)ethan-1-amine).
Diampromide.................................       9615  I
Diethylthiambutene..........................       9616  I
Dimenoxadol.................................       9617  I
Dimepheptanol...............................       9618  I
Dimethylthiambutene.........................       9619  I
Dioxaphetyl butyrate........................       9621  I

[[Page 20737]]

 
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-                      9663  I
 acetoxypiperidine.
Tilidine....................................       9750  I
Acryl fentanyl (N-(1-phenethylpiperidin-4-         9811  I
 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-phenethylpiperidin-4-      9816  I
 yl)propionamide.
Acetyl Fentanyl (N-(1-phenethylpiperidin-4-        9821  I
 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-yl)-N-         9825  I
 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-phenethylpiperidin-4-       9834  I
 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.
Crotonyl fentanyl ((E-N-(1-                        9844  I
 phenethylpiperidin-4-yl)-N-phenylbut-2-
 enamide).
Cyclopropyl Fentanyl........................       9845  I
Cyclopentyl fentanyl........................       9847  I
Fentanyl related-compounds as defined in 21        9850  I
 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 drug           7365  II
 product approved for marketing by the U.S.
 Food and Drug Administration.
Nabilone....................................       7379  II
1-Phenylcyclohexylamine.....................       7460  II
Phencyclidine...............................       7471  II
ANPP (4-Anilino-N-phenethyl-4-piperidine)...       8333  II
Norfentanyl (N-phenyl-N-(piperidin-4-yl)           8366  II
 propionamide).
Phenylacetone...............................       8501  II
1-Piperidinocyclohexanecarbonitrile.........       8603  II
Alphaprodine................................       9010  II
Anileridine.................................       9020  II
Coca Leaves.................................       9040  II
Cocaine.....................................       9041  II

[[Page 20738]]

 
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
Oliceridine (N-[(3-methoxythiophen-                9245  II
 2yl)methyl] ({2-[9r)-9-(pyridin-2-yl)-6-
 oxaspiro [4.5]decan-9-yl]ethyl{time{time}
 )amine fumarate).
Metopon.....................................       9260  II
Dextropropoxyphene, bulk (non-dosage forms).       9273  II
Dihydroetorphine............................       9334  II
Opium tincture..............................       9630  II
Opium, powdered.............................       9639  II
Opium, granulated...........................       9640  II
Noroxymorphone..............................       9668  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.
    Approval of permit applications will occur only when the 
registrant's business activity is consistent with what is authorized 
under 21 U.S.C. 952(a)(2). Authorization will not extend to the import 
of Food and Drug Administration-approved or non-approved finished 
dosage forms for commercial sale.

William T. McDermott,
Assistant Administrator.
[FR Doc. 2021-08166 Filed 4-20-21; 8:45 am]
BILLING CODE P