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Notice

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