Diversion Control Division, US Department of Justice, Drug Enforcement Administration

RESOURCES > Federal Register Notices > Importers Notice of Application - 2015 > Almac Clinical Services Inc. (ACSI)

Importers Notice of Application - 2015

[Federal Register Volume 80, Number 77 (Wednesday, April 22, 2015)]
[Notices]
[Pages 22556-22557]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-09333]


DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. DEA-392]

Importer of Controlled Substances Application: Almac Clinical Services Inc. (ACSI)

ACTION: Notice of application.


DATES: Registered bulk manufacturers of the affected basic classes, 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 22, 2015. Such persons may also file a written request for a hearing on the application pursuant to 21 CFR 1301.43 on or before May 22, 2015.

ADDRESSES: Written comments should be sent to: Drug Enforcement Administration, Attention: DEA Federal Register Representative/ODXL, 8701 Morrissette Drive, Springfield, Virginia 22152. Request for hearings should be sent to: Drug Enforcement Administration, Attention: Hearing Clerk/LJ, 8701 Morrissette Drive, Springfield, Virginia 22152.

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 Deputy Assistant Administrator of the DEA Office of Diversion Control ("Deputy 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 March

[[Page 22557]]

5, 2015, Almac Clinical Services Inc., (ACSI), 25 Fretz Road, Souderton, Pennsylvania 18964 applied to be registered as an importer of the following basic classes of controlled substances:

Controlled Substance Schedule
Oxycodone (9143) II
Hydromorphone (9150) II
Tapentadol (9780) II
Fentanyl (9801) II

The company plans to import small quantities of the listed controlled substances in dosage form to conduct clinical trials.

Dated: April 14, 2015.

Joseph T. Rannazzisi,
Deputy Assistant Administrator.

[FR Doc. 2015-09333 Filed 4-21-15; 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).

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