[Federal Register Volume 85, Number 67 (Tuesday, April 7, 2020)]
[Notices]
[Pages 19504-19505]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-07273]
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA-618]
Importer of Controlled Substances Application: Almac Clinical
Services Incorp (ACSI)
ACTION: Notice of application.
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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 May 7, 2020.
Such persons may also file a written request for a hearing on the
application on or before May 7, 2020.
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
[[Page 19505]]
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 March 6, 2020, 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
substances:
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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 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.
William T. McDermott,
Assistant Administrator.
[FR Doc. 2020-07273 Filed 4-6-20; 8:45 am]
BILLING CODE 4410-09-P