83 FR 34879 - Importer of Controlled Substances Applications: Shertech Laboratories, LLC

DEPARTMENT OF JUSTICE
Drug Enforcement Administration

Federal Register Volume 83, Issue 141 (July 23, 2018)

[Federal Register Volume 83, Number 141 (Monday, July 23, 2018)]
[Notices]
[Page 34879]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2018-15713]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. DEA-392]


Importer of Controlled Substances Applications: Shertech 
Laboratories, 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 August 22, 2018. 
Such persons may also file a written request for a hearing on the 
application on or before August 22, 2018.

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 April 
23, 2018, Shertech Laboratories, LLC, 1185 Woods Chapel Road, Duncan 
South Carolina 29334 applied to be registered as an importer of the 
following basic class of controlled substance:

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                                           Drug
          Controlled substance             Code          Schedule
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Cocaine................................     9041  II
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    The company plans to import synthetic derivatives of the listed 
controlled substance in bulk form 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: July 12, 2018.
John J. Martin,
Assistant Administrator.
[FR Doc. 2018-15713 Filed 7-20-18; 8:45 am]
 BILLING CODE 4410-09-P