[Federal Register Volume 80, Number 247 (Thursday, December 24, 2015)]
[Notices]
[Page 80387]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-32367]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. DEA-392]


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

ACTION: Notice of application.

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DATES: 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 January 25, 2016. Such persons may also file a 
written request for a hearing on the application pursuant to 21 CFR 
1301.43 on or before January 25, 2016.

ADDRESSES: Written comments should be sent to: Drug Enforcement 
Administration, Attention: DEA Federal Register Representative/ODW, 
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 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 
September 1, 2015, Almac Clinical Services Incorp (ACSI), 25 Fretz 
Road, Souderton, Pennsylvania 18964 applied to be registered as an 
importer of Morphine (9300), a basic class of controlled substance 
listed in schedule II.
    The company plans to import the listed controlled substance 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.

    Dated: December 15, 2015.
Louis J. Milione,
Deputy Assistant Administrator.
[FR Doc. 2015-32367 Filed 12-23-15; 8:45 am]
 BILLING CODE 4410-09-P