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RESOURCES > Federal Register Notices > Importers Notice of Application - 2021 > Almac Clinical Services Incorp. (ACSI)

Importers Notice of Application - 2021

[Federal Register Volume 86, Number 100 (Wednesday, May 26, 2021)]
[Notices]
[Page 28384]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-11069]


DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. DEA-840]

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

AGENCY: Drug Enforcement Administration, Justice.

ACTION: Notice of application.


SUMMARY: Almac Clinical Services Incorp. (ACSI) has applied to be registered as an importer of basic class(es) of controlled substance(s). Refer to Supplementary Information listed below for further drug information.

DATES: Registered bulk manufacturers of the affected basic class(es), and applicants therefore, may file written comments on or objections to the issuance of the proposed registration on or before June 25, 2021. Such persons may also file a written request for a hearing on the application on or before June 25, 2021.

ADDRESSES: Written comments should be sent to: Drug Enforcement Administration, Attention: DEA Federal Register Representative/DPW, 8701 Morrissette Drive, Springfield, Virginia 22152. All requests for a hearing must be sent to: Drug Enforcement Administration, Attn: Administrator, 8701 Morrissette Drive, Springfield, Virginia 22152. All request for a hearing should also be sent to: (1) Drug Enforcement Administration, Attn: Hearing Clerk/OALJ, 8701 Morrissette Drive, Springfield, Virginia 22152; and (2) Drug Enforcement Administration, Attn: DEA Federal Register Representative/DPW, 8701 Morrissette Drive, Springfield, Virginia 22152.

SUPPLEMENTARY INFORMATION: In accordance with 21 CFR 1301.34(a), this is notice that on April 30, 2021, Almac Clinical Services Incorp, (ACSI) 25 Fretz Road, Souderton, Pennsylvania 18964, applied to be registered as an importer of the following basic class(es) of controlled substance(s):

Controlled Substance Drug Code Schedule
Psilocybin 7437 I
Oxycodone 9143 II
Hydromorphone 9150 II
Morphine 9330 II
Noroxymorphone 9668 II
Tapentadol 9780 II
Fentanyl 9801 II

The company plans to import the listed finished dosage unit products 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 21 U.S.C. 952(a)(2). Authorization will not extend to import of the Food and Drug Administration-approved or non-approved finished dosage forms for commercial sale.

William T. McDermott,
Assistant Administrator.

[FR Doc. 2021-11069 Filed 5-25-21; 8:45 am]

BILLING CODE P

NOTICE: This is an unofficial version. An official version of this publication may be obtained directly from the Government Publishing Office (GPO).

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