83 FR 54612 - Importer of Controlled Substances Application: Sharp (Bethlehem), LLC

DEPARTMENT OF JUSTICE
Drug Enforcement Administration

Federal Register Volume 83, Issue 210 (October 30, 2018)

[Federal Register Volume 83, Number 210 (Tuesday, October 30, 2018)]
[Notices]
[Page 54612]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2018-23705]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. DEA-392]


Importer of Controlled Substances Application: Sharp (Bethlehem), 
LLC

ACTION: Notice of application.

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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 on or before November 29, 2018. 
Such persons may also file a written request for a hearing on the 
application on or before November 29, 2018.

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 
hearing must be sent to: Drug Enforcement Administration, Attn: 
Administrator, 8701 Morrissette Drive, Springfield, Virginia 22152. All 
requests for 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: 
    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 August 
30, 2018, Sharp (Bethlehem), LLC, 2400 Baglyos Circle, Bethlehem, 
Pennsylvania 18020, applied to be registered as an importer of the 
following basic class of controlled substances:

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        Controlled substance            Drug code          Schedule
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Gamma Hydroxybutyric Acid..........            2010  I
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    The company plans to import dosage forms of the listed controlled 
substances to conduct clinical trials.
    Approval of permit applications will occur only when the 
registrant's 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.

    Dated: October 22, 2018.
John J. Martin,
Assistant Administrator.
[FR Doc. 2018-23705 Filed 10-29-18; 8:45 am]
 BILLING CODE 4410-09-P