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Importers Notice of Application - 2021

[Federal Register Volume 86, Number 38 (Monday, March 1, 2021)]
[Notices]
[Pages 12033-12034]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-04147]


DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. DEA-799]

Importer of Controlled Substances Application: Microgenics Corporation Thermo Fisher Scientific

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.

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 Substance Drug Code Schedule
Cathinone 1235 I
Mephedrone (4-Methyl-N-methylcathinone) 1248 I
Gamma Hydroxybutyric Acid 2010 I
Methaqualone 2565 I
Mecloqualone 2572 I
2-(1-(4-fluorobenzyl)-1H-indazole-3-carboxamido)-3-methylbutanoate 7021 I
AB–PINACA (N-(1-amino-3-methyl-1-oxobutan-2-yl)-1-pentyl-1H-indazole-3-carboxamide) 7023 I
AB–CHMINACA (N-(1-amino-3-methyl-1-≤oxobutan-2-yl)-1-(cyclohexylmethyl)-1H-indazole-3-carboxamide 7031 I
MAB–CHMINACA (N-(1-amino-3,3dimethyl-1-oxobutan-2-yl)-1-(cyclohexylmethyl)-1H-indazole-3-carboxamide) 7032 I
5F–AMB (Methyl 2-(1-(5-fluoropentyl)-1H-indazole-3-carboxamido)-3-methylbutanoate) 7033 I
ADB–PINACA (N-(1-amino-3,3-dimethyl-1-oxobutan-2-yl)-1-pentyl-1H-indazole-3-carboxamide) 7035 I
APINACA and AKB48 N-(1-Adamantyl)-1-pentyl-1H-indazole-3-carboxamide 7048 I
AM2201 (1-(5-Fluoropentyl)-3-(1-naphthoyl) indole) 7201 I
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 (2C–I) 7518 I
MDPV (3,4-Methylenedioxypyrovalerone) 7535 I
2-(4-iodo-2,5-dimethoxyphenyl)-N-(2-methoxybenzyl) ethanamine (25I–NBOMe) 7538 I
Butylone 7541 I
Pentylone 7542 I
alpha-pyrrolidinopentiophenone (α-PVP) 7545 I
Normorphine 9313 I
AH–7921 (3,4-dichloro-N-[(1-dimethylamino)cyclohexylmethyl]benzamide)) 9551 I
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-yl)-N-phenylacetamide) 9821 I
2-methoxy-N-(1-phenethylpiperidin-4-yl)-N-phenylacetamide 9825 I
3-Methylthiofentanyl 9833 I
Cyclopropyl Fentanyl 9845 I
Fentanyl related-compounds as defined in 21 CFR 1308.11(h) 9850 I
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 forms) 9273 II
Morphine 9300 II
Thebaine 9333 II
Levo-alphacetylmethadol 9648 II
Oxymorphone 9652 II
Carfentanil 9743 II
Tapentadol 9780 II
Fentanyl 9801 II

[[Page 12034]]

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.

William T. McDermott,
Assistant Administrator.

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

BILLING CODE P

NOTICE: This is an unofficial version. An official version of this publication may be obtained directly from the Government Publishing Office (GPO).

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