[Federal Register Volume 82, Number 171 (Wednesday, September 6, 2017)]
[Notices]
[Pages 42119-42120]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-18787]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. DEA-392]


Importer of Controlled Substances Application: KVK-Tech, Inc.

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 in accordance with 21 CFR 
1301.34(a) on or before October 6, 2017. Such persons may also file a 
written request for a hearing on the application pursuant to 21 CFR 
1301.43 on or before October 6, 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

[[Page 42120]]

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 July 
18, 2016, KVK-Tech, Inc., 110 Terry Drive, Newtown, Pennsylvania 18940 
applied to be registered as an importer of Lisdexamfetamine (1205), a 
basic class of controlled substance listed in schedule II.
    The company plans to import the listed controlled substance in 
finished dosage form for clinical trials, research, and analytical 
purposes. 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 FDA approved or non-approved finished dosage forms for commercial 
sale.

    Dated: August 28, 2017.
Demetra Ashley,
Acting Assistant Administrator.
[FR Doc. 2017-18787 Filed 9-5-17; 8:45 am]
 BILLING CODE 4410-09-P