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Notice

Importer of Controlled Substances Application: Microgenics Corporation Thermo Fisher Scientific

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Start Preamble

AGENCY:

Drug Enforcement Administration, Justice.

ACTION:

Notice of application.

SUMMARY:

Microgenics Corporation Thermo Fisher Scientific has applied to be registered as an importer of basic class(es) of controlled substance(s). Refer to Supplemental 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 March 31, 2021. Such persons may also file a written request for a hearing on the application on or before March 31, 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 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, Attn: DEA Federal Register Representative/DPW, 8701 Morrissette Drive, Springfield, Virginia 22152.

End Preamble Start Supplemental Information

SUPPLEMENTARY INFORMATION:

In accordance with 21 CFR 1301.34(a), this is notice that on January 27, 2021, Microgenics Corporation Thermo Fisher Scientific, 46500 Kato Road Fremont, California 94538, has applied to be registered as an importer of the following basic classes of controlled substances:

Controlled substanceDrug codeSchedule
Cathinone1235I
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
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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 In Vitro Diagnostic quantitative assay. No other activity for these drug codes is authorized for this registration.

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 the Food and Drug Administration-approved or non-approved finished dosage forms for commercial sale.

Start Signature

William T. McDermott,

Assistant Administrator.

End Signature End Supplemental Information

[FR Doc. 2021-04147 Filed 2-26-21; 8:45 am]

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