2019-01513. Importer of Controlled Substances Application: Microgenics Corporation Thermo Fisher Scientific  

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    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.

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    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 substanceDrug codeSchedule
    Cathinone1235I
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    Mephedrone (4-Methyl-N-methylcathinone)1248I
    Gamma Hydroxybutyric Acid2010I
    Methaqualone2565I
    Mecloqualone2572I
    2-(1-(4-fluorobenzyl)-1Hindazole-3-carboxamido)-3-methylbutanoate7021I
    AB-PINACA (N-(1-amino-3-methyl-1-oxobutan-2-yl)-1-pentyl-1H-indazole-3-carboxamide)7023I
    AB-CHMINACA (N-(1-amino-3-methyl-1->oxobutan-2-yl)-1-(cyclohexylmethyl)-1H-indazole-3-carboxamide7031I
    MAB-CHMINACA (N-(1-amino-3,3dimethyl-1-oxobutan-2-yl)-1-(cyclohexylmethyl)-1H-indazole-3-carboxamide)7032I
    5F-AMB (Methyl 2-(1-(5-fluoropentyl)-1H-indazole-3-carboxamido)-3-methylbutanoate)7033I
    ADB-PINACA (N-(1-amino-3,3-dimethyl-1-oxobutan-2-yl)-1-pentyl-1H-indazole-3-carboxamide)7035I
    APINACA and AKB48 N-(1-Adamantyl)-1-pentyl-1H-indazole-3-carboxamide7048I
    AM2201 (1-(5-Fluoropentyl)-3-(1-naphthoyl) indole)7201I
    Lysergic acid diethylamide7315I
    Marihuana7360I
    Tetrahydrocannabinols7370I
    3,4-Methylenedioxyamphetamine7400I
    3,4-Methylenedioxy-N-ethylamphetamine7404I
    3,4-Methylenedioxymethamphetamine7405I
    2-(4-iodo-2,5-dimethoxyphenyl) ethanamine (2C-I)7518I
    MDPV (3,4-Methylenedioxypyrovalerone)7535I
    2-(4-iodo-2,5-dimethoxyphenyl)-N-(2-methoxybenzyl) ethanamine (25I-NBOMe)7538I
    Butylone7541I
    Pentylone7542I
    alpha-pyrrolidinopentiophenone (α-PVP)7545I
    Normorphine9313I
    AH-7921 (3,4-dichloro-N-[(1-dimethylamino)cyclohexylmethyl]benzamide))9551I
    Acetylmethadol9601I
    Alphamethadol9605I
    Ketobemidone9628I
    Noracymethadol9633I
    Para-Fluorofentanyl9812I
    3-Methylfentanyl9813I
    Alpha-methylfentanyl9814I
    Acetyl Fentanyl (N-(1-phenethylpiperidin-4-yl)-N-phenylacetamide)9821I
    2-methoxy-N-(1-phenethylpiperidin-4-yl)-N-phenylacetamide9825I
    3-Methylthiofentanyl9833I
    Cyclopropyl Fentanyl9845I
    Fentanyl related-compounds as defined in 21 CFR 1308.11&h)9850I
    Amphetamine1100II
    Methamphetamine1105II
    Methylphenidate1724II
    Amobarbital2125II
    Pentobarbital2270II
    Secobarbital2315II
    Phencyclidine7471II
    Cocaine9041II
    Codeine9050II
    Dihydrocodeine9120II
    Oxycodone9143II
    Hydromorphone9150II
    Ecgonine9180II
    Hydrocodone9193II
    Levorphanol9220II
    Meperidine9230II
    Meperidine intermediate-B9233II
    Methadone9250II
    Dextropropoxyphene, bulk (non-dosage forms)9273II
    Morphine9300II
    Thebaine9333II
    Levo-alphacetylmethadol9648II
    Oxymorphone9652II
    Carfentanil9743II
    Tapentadol9780II
    Fentanyl9801II

    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.

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    Dated: December 21, 2018.

    John J. Martin,

    Assistant Administrator.

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    [FR Doc. 2019-01513 Filed 2-6-19; 8:45 am]

    BILLING CODE 4410-09-P

Document Information

Published:
02/07/2019
Department:
Drug Enforcement Administration
Entry Type:
Notice
Action:
Notice of application.
Document Number:
2019-01513
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.
Pages:
2575-2576 (2 pages)
Docket Numbers:
Docket No. DEA-392
PDF File:
2019-01513.Pdf