Importers Notice of Application - 2020
[Federal Register Volume 85, Number 241 (Tuesday, December 15, 2020)]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-27509]
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA-753]
Importer of Controlled Substances Application: Adiramedica LLC
AGENCY: Drug Enforcement Administration, Justice.
ACTION: Notice of application.
SUMMARY: Adiramedica LLC has applied to be registered as an importer of a basic class of a controlled substance. Refer to Supplemental Information listed below for further drug information.
DATES: Registered bulk manufacturers of the affected basic class, and applicants therefore, may file written comments on or objections to the issuance of the proposed registration on or before January 14, 2021. Such persons may also file a written request for a hearing on the application on or before January 14, 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 requests 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 October 14, 2020, Adiramedica LLC, 585 Turner Industrial Way, Aston, Pennsylvania 19014, applied to be registered as an importer of the following basic class of a controlled substance:
|Controlled Substance||Drug Code||Schedule|
The company plans to import Tapentadol in dosage form for clinical trials. No other activity for this drug code is authorized for this registration.
Approval of permit applications will occur only when the registrant's activity is consistent with what is authorized under 21 U.S.C. 952(a)(2). Authorization will not extend to the import of Food and Drug Administration-approved or non-approved finished dosage forms for commercial sale.
William T. McDermott,
[FR Doc. 2020-27509 Filed 12-14-20; 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).