82 FR 37114 - Importer of Controlled Substances Application: Almac Clinical Services Incorp (ACSI)

DEPARTMENT OF JUSTICE
Drug Enforcement Administration

Federal Register Volume 82, Issue 151 (August 8, 2017)

Page Range37114-37115
FR Document2017-16699

Federal Register, Volume 82 Issue 151 (Tuesday, August 8, 2017)
[Federal Register Volume 82, Number 151 (Tuesday, August 8, 2017)]
[Notices]
[Pages 37114-37115]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2017-16699]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. DEA-392]


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

ACTION: Notice of application.

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[[Page 37115]]


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 in accordance with 21 CFR 
1301.34(a) on or before September 7, 2017. Such persons may also file a 
written request for a hearing on the application pursuant to 21 CFR 
1301.43 on or before September 7, 2017.

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, 2017, Almac Clinical Services Incorp (ACSI), 25 Fretz Road, 
Souderton, Pennsylvania 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 small quantities of the listed 
controlled substances in dosage form to conduct clinical trials.

    Dated: August 2, 2017.
Demetra Ashley,
Acting Assistant Administrator.
[FR Doc. 2017-16699 Filed 8-7-17; 8:45 am]
 BILLING CODE 4410-09-P


Current View
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionNotices
ActionNotice of application.
DatesRegistered bulk manufacturers of the affected basic classes, and applicants therefore, may file written comments on or objections to the issuance of the proposed registration in accordance with 21 CFR 1301.34(a) on or before September 7, 2017. Such persons may also file a written request for a hearing on the application pursuant to 21 CFR 1301.43 on or before September 7, 2017.
FR Citation82 FR 37114 

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