[Federal Register Volume 86, Number 223 (Tuesday, November 23, 2021)]
[Notices]
[Page 66589]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-25575]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. DEA-924]


Importer of Controlled Substances Application: Mylan 
Technologies, Inc.

AGENCY: Drug Enforcement Administration, Justice.

ACTION: Notice of application.

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SUMMARY: Mylan Technologies, Inc. has applied to be registered as an 
importer of basic class(es) of controlled substance(s). Refer to 
Supplementary Information listed below for further drug information.

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 December 23, 
2021. Such persons may also file a written request for a hearing on the 
application on or before December 23, 2021.

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: In accordance with 21 CFR 1301.34(a), this 
is notice that on October 22, 2021, Mylan Technologies, Inc., 110 Lake 
Street, Saint Albans, Vermont 05478-2266, applied to be registered as 
an importer of the following basic class(es) of controlled 
substance(s):

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         Controlled substance           Drug code         Schedule
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Methylphenidate.......................       1724  II
Fentanyl..............................       9801  II
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    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 finished 
dosage form to foreign markets. No other activity for these drug codes 
is authorized for this registration.
    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 Food and Drug Administration-approved or non-approved finished 
dosage forms for commercial sale.

Brian S. Besser,
Acting Assistant Administrator.
[FR Doc. 2021-25575 Filed 11-22-21; 8:45 am]
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