82 FR 63 pg. 16420 - Importer of Controlled Substances Application: Xcelience
Type: NOTICEVolume: 82Number: 63Page: 16420Page: 16420
Docket number: [Docket No. DEA-392]
FR document: [FR Doc. 2017-06555 Filed 4-3-17; 8:45 am]
Agency: Justice Department
Sub Agency: Drug Enforcement Administration
Official PDF Version: PDF Version
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA-392]
Importer of Controlled Substances Application: Xcelience
Notice of application.
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 in accordance with 21 CFR 1301.34(a) on or before May 4, 2017. Such persons may also file a written request for a hearing on the application pursuant to 21 CFR 1301.43 on or before May 4, 2017.
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.
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 of subpart R.
In accordance with 21 CFR 1301.34(a), this is notice that on September 30, 2016, Xcelience, 4901 West Grace Street, Tampa, Florida 33607 applied to be registered as an importer of amphetamine (1100), a basic class of controlled substance listed in schedule II.
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: March 24, 2017.
Louis J. Milione,
[FR Doc. 2017-06555 Filed 4-3-17; 8:45 am]
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