Importer of Controlled Substances Application: Almac Clinical Services Incorp (ACSI)
Federal Register, Volume 83 Issue 70 (Wednesday, April 11, 2018)
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
