[Federal Register Volume 87, Number 209 (Monday, October 31, 2022)]
[Notices]
[Pages 65609-65610]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-23613]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. DEA-1108]


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 submit electronic comments on or 
objections to the issuance of the proposed registration on or before 
November 30, 2022. Such persons may also file a written request for a 
hearing on the application on or before November 30, 2022.

ADDRESSES: The Drug Enforcement Administration requires that all 
comments be submitted electronically through the Federal eRulemaking 
Portal, which provides the ability to type short comments directly into 
the comment field on the web page or attach a file for lengthier 
comments. Please go to https://www.regulations.gov and follow the 
online instructions at that site for submitting comments. Upon 
submission of your comment, you will receive a Comment Tracking Number. 
Please be aware that submitted comments are not instantaneously 
available for public view on https://www.regulations.gov. If you have 
received a Comment Tracking Number, your comment has been successfully 
submitted and there is no need to resubmit the same comment. All 
requests for a hearing must 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. All requests for a hearing should also be 
sent to: Drug Enforcement Administration, Attn: Administrator, 8701 
Morrissette Drive, Springfield, Virginia 22152.

SUPPLEMENTARY INFORMATION: In accordance with 21 CFR 1301.34(a), this 
is notice that on October 4, 2022, 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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                                           Drug
          Controlled substance             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 FDF to foreign 
markets. No other activity for this drug code 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).

[[Page 65610]]

    Authorization will not extend to the import of Food and Drug 
Administration-approved or non-approved finished dosage forms for 
commercial sale.

Kristi O'Malley,
Assistant Administrator.
[FR Doc. 2022-23613 Filed 10-28-22; 8:45 am]
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