Importers Notice of Application - 2020
[Federal Register Volume 85, Number 87 (Tuesday, May 5, 2020)]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-09514]
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA-611]
Importer of Controlled Substances Application: Unither Manufacturing LLC
ACTION: Notice of application.
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 June 4, 2020. Such persons may also file a written request for a hearing on the application on or before June 4, 2020.
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 February 27, 2020, Unither Manufacturing LLC, 331 Clay Road, Rochester, New York 14623, applied to be registered as an importer of the following basic class(es) of a controlled substance:
|Controlled Substance||Drug Code||Schedule|
The company plans to import the listed controlled substance solely for updated analytical testing purposes for European customer requirements. This analysis is required to allow the company to export domestically-manufactured finished dosage forms to foreign markets. Approval of permit applications will occur only when the registrant's activity is consistent with what is authorized under to 21 U.S.C. 952(a)(2). Authorization will not extend to the import of FDA-approved or non-approved finished dosage forms for commercial sale.
William T. McDermott,
[FR Doc. 2020-09514 Filed 5-4-20; 8:45 am]
BILLING CODE 4410-09-P
NOTICE: This is an unofficial version. An official version of this publication may be obtained directly from the Government Publishing Office (GPO).