[Federal Register Volume 80, Number 197 (Tuesday, October 13, 2015)]
[Notices]
[Page 61469]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-25881]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. DEA-392]


Importer of Controlled Substances Registration: Unither 
Manufacturing, LLC

ACTION: Notice of registration.

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SUMMARY: Unither Manufacturing, LLC applied to be registered as an 
importer of a certain basic class of controlled substance. The Drug 
Enforcement Administration (DEA) grants Unither Manufacturing, LLC 
registration as an importer of this controlled substance.

SUPPLEMENTARY INFORMATION: By notice dated April 14, 2015, and 
published in the Federal Register on April 22, 2015, 80 FR 22552, 
Unither Manufacturing, LLC, 331 Clay Road, Rochester, New York 14623 
applied to be registered as an importer of a certain basic class of 
controlled substance. No comments or objections were submitted for this 
notice.
    The DEA has considered the factors in 21 U.S.C. 823, 952(a) and 
958(a) and determined that the registration of Unither Manufacturing, 
LLC to import the basic class of controlled substance is consistent 
with the public interest and with United States obligations under 
international treaties, conventions, or protocols in effect on May 1, 
1971. The DEA investigated the company's maintenance of effective 
controls against diversion by inspecting and testing the company's 
physical security systems, verifying the company's compliance with 
state and local laws, and reviewing the company's background and 
history.
    Therefore, pursuant to 21 U.S.C. 952(a) and 958(a), and in 
accordance with 21 CFR 1301.34, the above-named company is granted 
registration as an importer of methylphenidate (1724), a basic class of 
controlled substance listed in schedule II.
    The company plans to import the listed substance as a raw material 
for updated testing purposes for EU customer requirements.
    The company plans to import the listed controlled substances in 
finished dosage form (FDF) from foreign sources for analytical testing 
and clinical trials in which the foreign FDF will be compared to the 
company's own domestically-manufactured FDF. This analysis is required 
to allow the company to export domestically-manufactured FDF to foreign 
markets.

    Dated: October 2, 2015.
Louis J. Milione,
Deputy Assistant Administrator.
[FR Doc. 2015-25881 Filed 10-9-15; 8:45 am]
BILLING CODE 4410-09-P