[Federal Register Volume 83, Number 70 (Wednesday, April 11, 2018)]
[Notices]
[Page 15634]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-07441]


-----------------------------------------------------------------------

DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. DEA-392]


Importer of Controlled Substances Application: Almac Clinical 
Services Incorp (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 on or before May 11, 2018. Such 
persons may also file a written request for a hearing on the 
application on or before May 11, 2018.

ADDRESSES: Written comments should be sent to: Drug Enforcement 
Administration, Attention: DEA Federal Register Representative/DRW, 
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 
request 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/DRW, 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 Assistant Administrator of the DEA Diversion Control Division 
(``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 
7, 2018, Almac Clinical Services Incorp (ACSI) 25 Fretz Road, 
Souderton, PA 18964 applied to be registered as an importer of the 
following basic classes of controlled substances:

 
------------------------------------------------------------------------
         Controlled substance           Drug code         Schedule
------------------------------------------------------------------------
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 to conduct clinical trials.
    Approval of permit applications will occur only when the 
registrant's business activity is consistent with what is authorized 
under to 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: April 3, 2018
Susan A. Gibson,
Deputy Assistant Administrator.
[FR Doc. 2018-07441 Filed 4-10-18; 8:45 am]
 BILLING CODE 4410-09-P