[Federal Register Volume 84, Number 67 (Monday, April 8, 2019)]
[Notices]
[Pages 13961-13962]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-06850]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. DEA-392]


Importer of Controlled Substances Application: Unither 
Manufacturing LLC

ACTION: Notice of application.

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[[Page 13962]]


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 May 8, 2019. Such 
persons may also file a written request for a hearing on the 
application on or before May 8, 2019.

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 
requests for a 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 
February 4, 2019, Unither Manufacturing LLC, 331 Clay Road, Rochester, 
New York 14623-3226 applied to be registered as an importer of the 
following basic class of controlled substance:

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        Controlled substance            Drug code         Schedule
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Methylphenidate.....................         1724   II
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    The company plans to import the listed substance solely for updated 
analytical testing purposes for EU customer requirements. This analysis 
is required to allow the company to export domestically-manufactured 
finished dosage forms to foreign markets.
    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: March 21, 2019.
John J. Martin,
Assistant Administrator.
[FR Doc. 2019-06850 Filed 4-5-19; 8:45 am]
 BILLING CODE 4410-09-P