Importers Notice of Application - 2021
[Federal Register Volume 86, Number 38 (Monday, March 1, 2021)]
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|
|Gamma Hydroxybutyric Acid||2010||I|
|5F–AMB (Methyl 2-(1-(5-fluoropentyl)-1H-indazole-3-carboxamido)-3-methylbutanoate)||7033||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|
|2-(4-iodo-2,5-dimethoxyphenyl) ethanamine (2C–I)||7518||I|
|2-(4-iodo-2,5-dimethoxyphenyl)-N-(2-methoxybenzyl) ethanamine (25I–NBOMe)||7538||I|
|Acetyl Fentanyl (N-(1-phenethylpiperidin-4-yl)-N-phenylacetamide)||9821||I|
|Fentanyl related-compounds as defined in 21 CFR 1308.11(h)||9850||I|
|Dextropropoxyphene, bulk (non-dosage forms)||9273||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 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,
[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).