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Notice

Importer of Controlled Substances Application: ALMAC Clinical Services Incorp (ACSI)

Document Details

Information about this document as published in the Federal Register.

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This document has been published in the Federal Register. Use the PDF linked in the document sidebar for the official electronic format.

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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 September 15, 2016. Such persons may also file a written request for a hearing on the application pursuant to 21 CFR 1301.43 on or before September 15, 2016.

ADDRESSES:

Written comments should be sent to: Drug Enforcement Administration, Attention: DEA Federal Register Representative/ODW, 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 requests 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/ODW, 8701 Morrissette Drive, Springfield, Virginia 22152.

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SUPPLEMENTARY INFORMATION:

The Attorney General has delegated her 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 June 29, 2016, ALMAC Clinical Services Incorp (ACSI), 25 Fretz Road, Souderton, Pennsylvania 18964 applied to be registered as an importer of the following basic classes of controlled substances:

Controlled substanceSchedule
Oxycodone (9143)II
Hydromorphone (9150)II
Morphine (9300)II
Tapentadol (9780)II
Fentanyl (9801)II

The company plans to import the listed controlled substances in dosage form for clinical trial only. Approval of permit applications will occur only when the registrant's business activity is consistent with what is authorized under 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.

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Louis J. Milione,

Deputy Assistant Administrator.

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[FR Doc. 2016-19439 Filed 8-15-16; 8:45 am]

BILLING CODE 4410-09-P