Importers Notice of Application - 2018
[Federal Register Volume 83, Number 94 (Tuesday, May 15, 2018)]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-10300]
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA-392]
Importer of Controlled Substances Application: Xcelience
ACTION: Notice of application.
DATES: Registered bulk importers of the affected basic classes, and applicants therefore, may file written comments on or objections to the issuance of the proposed registration on or before June 14, 2018. Such persons may also file a written request for a hearing on the application on or before June 14, 2018.
ADDRESSES: Written comments should be sent to: Drug Enforcement Administration, Attention: DEA Federal Register Representative/DRW, 8701 Morrissette Drive, Springfield, Virginia 22152. All requests for hearing must be sent to: Drug Enforcement Administration, Attn: Administrator, 8701 Morrissette Drive, Springfield, Virginia 22152. All request for hearing should also be sent to: (1) Drug Enforcement Administration, Attn: Hearing Clerk/LJ, 8701 Morrissette Drive, Springfield, Virginia 22152; and (2) Drug Enforcement Administration, Attn: DEA Federal Register Representative/DRW, 8701 Morrissette Drive, Springfield, Virginia 22152. Comments and requests for hearings on applications to import narcotic raw material are not appropriate. 72 FR 3417, (January 25, 2007)
SUPPLEMENTARY INFORMATION: The Attorney General has delegated his authority under the Controlled Substances Act to the Administrator of the Drug Enforcement Administration (DEA), 28 CFR 0.100(b). Authority to exercise all necessary functions with respect to the promulgation and implementation of 21 CFR part 1301, incident to the registration of manufacturers, distributors, dispensers, importers, and exporters of controlled substances (other than final orders in connection with suspension, denial, or revocation of registration) has been redelegated to the Assistant Administrator of the DEA Diversion Control Division ("Assistant Administrator") pursuant to section 7 of 28 CFR part 0, appendix to subpart R.
In accordance with 21 CFR 1301.34(a), this is notice that on April 11, 2018, Xcelience, 4901 West Grace Street, Tampa, FL 33607 applied to be registered as an importer of the following basic classes of controlled substances:
|Controlled Substance||Drug Code||Schedule|
The company plans to import the listed controlled substance in finished dosage form for clinical trials, research and analytical purposes.
The import of this class of controlled substance will be granted only for analytical testing, research and clinical trials. This authorization does not extend to the import of a finished FDA approved or non-approved dosage form for commercial sale.
Dated: April 25, 2018.
Susan A. Gibson,
Deputy Assistant Administrator.
[FR Doc. 2018-10300 Filed 5-14-18; 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).