81 FR 54602 - Importer of Controlled Substances Application: ALMAC Clinical Services Incorp (ACSI)

DEPARTMENT OF JUSTICE
Drug Enforcement Administration

Federal Register Volume 81, Issue 158 (August 16, 2016)

[Federal Register Volume 81, Number 158 (Tuesday, August 16, 2016)]
[Notices]
[Page 54602]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2016-19439]


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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 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.

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:

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                  Controlled substance                       Schedule
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Oxycodone (9143)........................................              II
Hydromorphone (9150)....................................              II
Morphine (9300).........................................              II
Tapentadol (9780).......................................              II
Fentanyl (9801).........................................              II
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    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.

Louis J. Milione,
Deputy Assistant Administrator.
[FR Doc. 2016-19439 Filed 8-15-16; 8:45 am]
BILLING CODE 4410-09-P