[Federal Register Volume 88, Number 101 (Thursday, May 25, 2023)]
[Notices]
[Page 33916]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-11173]
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA-1198]
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 submit electronic comments on or
objections to the issuance of the proposed registration on or before
June 26, 2023. Such persons may also file a written request for a
hearing on the application on or before June 26, 2023.
ADDRESSES: The Drug Enforcement Administration requires that all
comments be submitted electronically through the Federal eRulemaking
Portal, which provides the ability to type short comments directly into
the comment field on the web page or attach a file for lengthier
comments. Please go to https://www.regulations.gov and follow the
online instructions at that site for submitting comments. Upon
submission of your comment, you will receive a Comment Tracking Number.
Please be aware that submitted comments are not instantaneously
available for public view on https://www.regulations.gov. If you have
received a Comment Tracking Number, your comment has been successfully
submitted and there is no need to resubmit the same comment. All
requests for a hearing must 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. All requests for a hearing should also be
sent to: Drug Enforcement Administration, Attn: Administrator, 8701
Morrissette Drive, Springfield, Virginia 22152.
SUPPLEMENTARY INFORMATION: In accordance with 21 CFR 1301.34(a), this
is notice that on May 1, 2023, 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................................ 9300 II
Tapentadol.............................. 9780 II
Fentanyl................................ 9801 II
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The company plans to import the listed controlled substances as
finished dosage form units for clinical trials purposes only. No other
activities for these drug codes are authorized for this registration.
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 the import
of Food and Drug Administration-approved or non-approved finished
dosage forms for commercial sale.
Matthew Strait,
Deputy Assistant Administrator.
[FR Doc. 2023-11173 Filed 5-24-23; 8:45 am]
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