Importer of Controlled Substances Application: Microgenics Corporation Thermo Fisher Scientific, 2575-2576 [2019-01513]

Download as PDF 2575 Federal Register / Vol. 84, No. 26 / Thursday, February 7, 2019 / Notices Drug code Controlled substance Meperidine intermediate-B ...................................................................................................................................................... Meperidine intermediate-C ...................................................................................................................................................... Metazocine .............................................................................................................................................................................. Methadone ............................................................................................................................................................................... Methadone intermediate .......................................................................................................................................................... Metopon ................................................................................................................................................................................... Dextropropoxyphene, bulk (non-dosage forms) ...................................................................................................................... Morphine .................................................................................................................................................................................. Oripavine ................................................................................................................................................................................. Thebaine .................................................................................................................................................................................. Dihydroetorphine ..................................................................................................................................................................... Opium, raw .............................................................................................................................................................................. Opium extracts ........................................................................................................................................................................ Opium fluid extract .................................................................................................................................................................. Opium tincture ......................................................................................................................................................................... Opium, powdered .................................................................................................................................................................... Opium, granulated ................................................................................................................................................................... Levo-alphacetylmethadol ......................................................................................................................................................... Opium poppy ........................................................................................................................................................................... Oxymorphone .......................................................................................................................................................................... Noroxymorphone ..................................................................................................................................................................... Poppy Straw Concentrate ....................................................................................................................................................... Phenazocine ............................................................................................................................................................................ Piminodine ............................................................................................................................................................................... Racemethorphan ..................................................................................................................................................................... Racemorphan .......................................................................................................................................................................... Alfentanil .................................................................................................................................................................................. Remifentanil ............................................................................................................................................................................. Sufentanil ................................................................................................................................................................................. Carfentanil ............................................................................................................................................................................... Tapentadol ............................................................................................................................................................................... Bezitramide .............................................................................................................................................................................. Fentanyl ................................................................................................................................................................................... Moramide-intermediate ............................................................................................................................................................ 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 DEPARTMENT OF JUSTICE Drug Enforcement Administration [Docket No. DEA–392] Importer of Controlled Substances Application: Microgenics Corporation Thermo Fisher Scientific ACTION: Notice of application. Registered bulk manufacturers of the affected basic classes, and DATES: 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. 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 request 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. ADDRESSES: The Attorney General has delegated his SUPPLEMENTARY INFORMATION: Drug code Cathinone ................................................................................................................................................................................ 18:55 Feb 06, 2019 Jkt 247001 PO 00000 Frm 00089 Fmt 4703 Sfmt 4703 II II II II II II II II II II II II II II II II II II II II II II II II II II II II II II II II II II 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 October 23, 2018, Microgenics Corporation/ Thermo Fisher Scientific located at 46500 Kato Rd., Fremont, California 94538, applied to be registered as an importer of the below listed basic classes of controlled substance listed in schedules I and II. Controlled substance VerDate Sep<11>2014 9233 9234 9240 9250 9254 9260 9273 9300 9330 9333 9334 9600 9610 9620 9630 9639 9640 9648 9650 9652 9668 9670 9715 9730 9732 9733 9737 9739 9740 9743 9780 9800 9801 9802 Schedule E:\FR\FM\07FEN1.SGM 07FEN1 1235 Schedule I 2576 Federal Register / Vol. 84, No. 26 / Thursday, February 7, 2019 / Notices Drug code Controlled substance Mephedrone (4-Methyl-N-methylcathinone) ............................................................................................................................ Gamma Hydroxybutyric Acid ................................................................................................................................................... Methaqualone .......................................................................................................................................................................... Mecloqualone .......................................................................................................................................................................... 2-(1-(4-fluorobenzyl)-1Hindazole-3-carboxamido)-3-methylbutanoate .................................................................................... AB–PINACA (N-(1-amino-3-methyl-1-oxobutan-2-yl)-1-pentyl-1H-indazole-3-carboxamide) ................................................. AB–CHMINACA (N-(1-amino-3-methyl-1-≤oxobutan-2-yl)-1-(cyclohexylmethyl)-1H-indazole-3-carboxamide ....................... MAB–CHMINACA (N-(1-amino-3,3dimethyl-1-oxobutan-2-yl)-1-(cyclohexylmethyl)-1H-indazole-3-carboxamide) ................ 5F–AMB (Methyl 2-(1-(5-fluoropentyl)-1H-indazole-3-carboxamido)-3-methylbutanoate) ...................................................... ADB–PINACA (N-(1-amino-3,3-dimethyl-1-oxobutan-2-yl)-1-pentyl-1H-indazole-3-carboxamide) ......................................... APINACA and AKB48 N-(1-Adamantyl)-1-pentyl-1H-indazole-3-carboxamide ...................................................................... AM2201 (1-(5-Fluoropentyl)-3-(1-naphthoyl) indole) ............................................................................................................... Lysergic acid diethylamide ...................................................................................................................................................... Marihuana ................................................................................................................................................................................ Tetrahydrocannabinols ............................................................................................................................................................ 3,4-Methylenedioxyamphetamine ............................................................................................................................................ 3,4-Methylenedioxy-N-ethylamphetamine ............................................................................................................................... 3,4-Methylenedioxymethamphetamine .................................................................................................................................... 2-(4-iodo-2,5-dimethoxyphenyl) ethanamine (2C–I) ............................................................................................................... MDPV (3,4-Methylenedioxypyrovalerone) ............................................................................................................................... 2-(4-iodo-2,5-dimethoxyphenyl)-N-(2-methoxybenzyl) ethanamine (25I–NBOMe) ................................................................. Butylone ................................................................................................................................................................................... Pentylone ................................................................................................................................................................................. alpha-pyrrolidinopentiophenone (a-PVP) ................................................................................................................................ Normorphine ............................................................................................................................................................................ AH–7921 (3,4-dichloro-N-[(1-dimethylamino)cyclohexylmethyl]benzamide)) ......................................................................... Acetylmethadol ........................................................................................................................................................................ Alphamethadol ......................................................................................................................................................................... Ketobemidone ......................................................................................................................................................................... Noracymethadol ...................................................................................................................................................................... Para-Fluorofentanyl ................................................................................................................................................................. 3-Methylfentanyl ...................................................................................................................................................................... Alpha-methylfentanyl ............................................................................................................................................................... Acetyl Fentanyl (N-(1-phenethylpiperidin-4-yl)-N-phenylacetamide) ...................................................................................... 2-methoxy-N-(1-phenethylpiperidin-4-yl)-N-phenylacetamide ................................................................................................. 3-Methylthiofentanyl ................................................................................................................................................................ Cyclopropyl Fentanyl ............................................................................................................................................................... Fentanyl related-compounds as defined in 21 CFR 1308.11&h) ........................................................................................... Amphetamine .......................................................................................................................................................................... Methamphetamine ................................................................................................................................................................... Methylphenidate ...................................................................................................................................................................... Amobarbital ............................................................................................................................................................................. Pentobarbital ........................................................................................................................................................................... Secobarbital ............................................................................................................................................................................. Phencyclidine .......................................................................................................................................................................... Cocaine ................................................................................................................................................................................... Codeine ................................................................................................................................................................................... Dihydrocodeine ........................................................................................................................................................................ Oxycodone .............................................................................................................................................................................. Hydromorphone ....................................................................................................................................................................... Ecgonine .................................................................................................................................................................................. Hydrocodone ........................................................................................................................................................................... Levorphanol ............................................................................................................................................................................. Meperidine ............................................................................................................................................................................... Meperidine intermediate-B ...................................................................................................................................................... Methadone ............................................................................................................................................................................... Dextropropoxyphene, bulk (non-dosage forms) ...................................................................................................................... Morphine .................................................................................................................................................................................. Thebaine .................................................................................................................................................................................. Levo-alphacetylmethadol ......................................................................................................................................................... Oxymorphone .......................................................................................................................................................................... Carfentanil ............................................................................................................................................................................... Tapentadol ............................................................................................................................................................................... Fentanyl ................................................................................................................................................................................... The company plans to import the listed controlled substances for feasibility studies for new products and cross reactivity studies for existing products. The products will serve as VerDate Sep<11>2014 17:23 Feb 06, 2019 Jkt 247001 raw materials for InVitro Diagnostic quantitative assay. PO 00000 1248 2010 2565 2572 7021 7023 7031 7032 7033 7035 7048 7201 7315 7360 7370 7400 7404 7405 7518 7535 7538 7541 7542 7545 9313 9551 9601 9605 9628 9633 9812 9813 9814 9821 9825 9833 9845 9850 1100 1105 1724 2125 2270 2315 7471 9041 9050 9120 9143 9150 9180 9193 9220 9230 9233 9250 9273 9300 9333 9648 9652 9743 9780 9801 Schedule I I I I I I I I I I I I I I I I I I I I I I I I I I I I I I I I I I I I I I II II II II II II II II II II II II II II II II II II II II II II II II II II Dated: December 21, 2018. John J. Martin, Assistant Administrator. [FR Doc. 2019–01513 Filed 2–6–19; 8:45 am] BILLING CODE 4410–09–P Frm 00090 Fmt 4703 Sfmt 4703 E:\FR\FM\07FEN1.SGM 07FEN1

Agencies

[Federal Register Volume 84, Number 26 (Thursday, February 7, 2019)]
[Notices]
[Pages 2575-2576]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-01513]


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

DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. DEA-392]


Importer of Controlled Substances Application: Microgenics 
Corporation Thermo Fisher Scientific

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 
request 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 
October 23, 2018, Microgenics Corporation/Thermo Fisher Scientific 
located at 46500 Kato Rd., Fremont, California 94538, applied to be 
registered as an importer of the below listed basic classes of 
controlled substance listed in schedules I and II.

------------------------------------------------------------------------
           Controlled substance               Drug code       Schedule
------------------------------------------------------------------------
Cathinone.................................  1235.........  I

[[Page 2576]]

 
Mephedrone (4-Methyl-N-methylcathinone)...  1248.........  I
Gamma Hydroxybutyric Acid.................  2010.........  I
Methaqualone..............................  2565.........  I
Mecloqualone..............................  2572.........  I
2-(1-(4-fluorobenzyl)-1Hindazole-3-         7021.........  I
 carboxamido)-3-methylbutanoate.
AB-PINACA (N-(1-amino-3-methyl-1-oxobutan-  7023.........  I
 2-yl)-1-pentyl-1H-indazole-3-carboxamide).
AB-CHMINACA (N-(1-amino-3-methyl-1-         7031.........  I
 >oxobutan-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).
ADB-PINACA (N-(1-amino-3,3-dimethyl-1-      7035.........  I
 oxobutan-2-yl)-1-pentyl-1H-indazole-3-
 carboxamide).
APINACA and AKB48 N-(1-Adamantyl)-1-pentyl- 7048.........  I
 1H-indazole-3-carboxamide.
AM2201 (1-(5-Fluoropentyl)-3-(1-naphthoyl)  7201.........  I
 indole).
Lysergic acid diethylamide................  7315.........  I
Marihuana.................................  7360.........  I
Tetrahydrocannabinols.....................  7370.........  I
3,4-Methylenedioxyamphetamine.............  7400.........  I
3,4-Methylenedioxy-N-ethylamphetamine.....  7404.........  I
3,4-Methylenedioxymethamphetamine.........  7405.........  I
2-(4-iodo-2,5-dimethoxyphenyl) ethanamine   7518.........  I
 (2C-I).
MDPV (3,4-Methylenedioxypyrovalerone).....  7535.........  I
2-(4-iodo-2,5-dimethoxyphenyl)-N-(2-        7538.........  I
 methoxybenzyl) ethanamine (25I-NBOMe).
Butylone..................................  7541.........  I
Pentylone.................................  7542.........  I
alpha-pyrrolidinopentiophenone ([alpha]-    7545.........  I
 PVP).
Normorphine...............................  9313.........  I
AH-7921 (3,4-dichloro-N-[(1-                9551.........  I
 dimethylamino)cyclohexylmethyl]benzamide)
 ).
Acetylmethadol............................  9601.........  I
Alphamethadol.............................  9605.........  I
Ketobemidone..............................  9628.........  I
Noracymethadol............................  9633.........  I
Para-Fluorofentanyl.......................  9812.........  I
3-Methylfentanyl..........................  9813.........  I
Alpha-methylfentanyl......................  9814.........  I
Acetyl Fentanyl (N-(1-phenethylpiperidin-4- 9821.........  I
 yl)-N-phenylacetamide).
2-methoxy-N-(1-phenethylpiperidin-4-yl)-N-  9825.........  I
 phenylacetamide.
3-Methylthiofentanyl......................  9833.........  I
Cyclopropyl Fentanyl......................  9845.........  I
Fentanyl related-compounds as defined in    9850.........  I
 21 CFR 1308.11&h).
Amphetamine...............................  1100.........  II
Methamphetamine...........................  1105.........  II
Methylphenidate...........................  1724.........  II
Amobarbital...............................  2125.........  II
Pentobarbital.............................  2270.........  II
Secobarbital..............................  2315.........  II
Phencyclidine.............................  7471.........  II
Cocaine...................................  9041.........  II
Codeine...................................  9050.........  II
Dihydrocodeine............................  9120.........  II
Oxycodone.................................  9143.........  II
Hydromorphone.............................  9150.........  II
Ecgonine..................................  9180.........  II
Hydrocodone...............................  9193.........  II
Levorphanol...............................  9220.........  II
Meperidine................................  9230.........  II
Meperidine intermediate-B.................  9233.........  II
Methadone.................................  9250.........  II
Dextropropoxyphene, bulk (non-dosage        9273.........  II
 forms).
Morphine..................................  9300.........  II
Thebaine..................................  9333.........  II
Levo-alphacetylmethadol...................  9648.........  II
Oxymorphone...............................  9652.........  II
Carfentanil...............................  9743.........  II
Tapentadol................................  9780.........  II
Fentanyl..................................  9801.........  II
------------------------------------------------------------------------

    The company plans to import the listed controlled substances for 
feasibility studies for new products and cross reactivity studies for 
existing products. The products will serve as raw materials for InVitro 
Diagnostic quantitative assay.

    Dated: December 21, 2018.
John J. Martin,
Assistant Administrator.
[FR Doc. 2019-01513 Filed 2-6-19; 8:45 am]
 BILLING CODE 4410-09-P
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