[Federal Register Volume 85, Number 87 (Tuesday, May 5, 2020)]
[Notices]
[Pages 26715-26716]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-09514]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. DEA-611]


Importer of Controlled Substances Application: Unither 
Manufacturing LLC

ACTION: Notice of application.

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DATES: Registered bulk manufacturers of the affected basic class(es), 
and applicants therefore, may file written comments on or objections to 
the issuance of the proposed registration on or before June 4, 2020. 
Such persons may also file a written request for a hearing on the 
application on or before June 4, 2020.

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

[[Page 26716]]

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: In accordance with 21 CFR 1301.34(a), this 
is notice that on February 27, 2020, Unither Manufacturing LLC, 331 
Clay Road, Rochester, New York 14623, applied to be registered as an 
importer of the following basic class(es) of a controlled substance:

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                                           Drug
          Controlled substance             code          Schedule
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Methylphenidate........................     1724  II
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    The company plans to import the listed controlled substance solely 
for updated analytical testing purposes for European 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.

William T. McDermott,
Assistant Administrator.
[FR Doc. 2020-09514 Filed 5-4-20; 8:45 am]
 BILLING CODE 4410-09-P