[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]


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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.

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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):

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                                           Drug
          Controlled substance             code          Schedule
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Psilocybin.............................     7437  I
Oxycodone..............................     9143  II
Hydromorphone..........................     9150  II
Morphine...............................     9330  II
Noroxymorphone.........................     9668  II
Tapentadol.............................     9780  II
Fentanyl...............................     9801  II
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    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]
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