[Federal Register Volume 77, Number 81 (Thursday, April 26, 2012)]
[Notices]
[Page 24985]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2012-10053]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration


Importer of Controlled Substances; Notice of Application; Almac 
Clinical Services, Inc., (ACSI)

    Pursuant to 21 U.S.C. 958(i), the Attorney General shall, prior to 
issuing a registration under this Section to a bulk manufacturer of a 
controlled substance in schedule I or II, and prior to issuing a 
regulation under 21 U.S.C. 952(a)(2), authorizing the importation of 
such a substance, provide manufacturers holding registrations for the 
bulk manufacture of the substance an opportunity for a hearing.
    Therefore, in accordance with 21 CFR 1301.34(a), this is notice 
that on March 5, 2012, Almac Clinical Services, Inc., (ACSI), 25 Fretz 
Road, Souderton, Pennsylvania 18964, made application by renewal to the 
Drug Enforcement Administration (DEA) to be registered as an importer 
of the following basic classes of controlled substances:

------------------------------------------------------------------------
                    Drug                               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.
    Any bulk manufacturer who is presently, or is applying to be, 
registered with DEA to manufacture such basic classes of controlled 
substances may file comments or objections to the issuance of the 
proposed registration and may, at the same time, file a written request 
for a hearing on such application pursuant to 21 CFR 1301.43, and in 
such form as prescribed by 21 CFR 1316.47.
    Any such written comments or objections should be addressed, in 
quintuplicate, to the Drug Enforcement Administration, Office of 
Diversion Control, Federal Register Representative (ODL), 8701 
Morrissette Drive, Springfield, Virginia 22152; and must be filed no 
later than May 29, 2012.
    This procedure is to be conducted simultaneously with, and 
independent of, the procedures described in 21 CFR 1301.34(b), (c), 
(d), (e), and (f). As noted in a previous notice published in the 
Federal Register on September 23, 1975, 40 FR 43745-46, all applicants 
for registration to import the basic class of any controlled substance 
in schedule I or II are, and will continue to be, required to 
demonstrate to the Deputy Assistant Administrator, Office of Diversion 
Control, Drug Enforcement Administration, that the requirements for 
such registration pursuant to 21 U.S.C. 958(a); 21 U.S.C. 823(a); and 
21 CFR 1301.34(b), (c), (d), (e), and (f) are satisfied.

     Dated: April 17, 2012.
Joseph T. Rannazzisi,
Deputy Assistant Administrator, Office of Diversion Control, Drug 
Enforcement Administration.
[FR Doc. 2012-10053 Filed 4-25-12; 8:45 am]
BILLING CODE 4410-09-P