[Federal Register Volume 89, Number 15 (Tuesday, January 23, 2024)]
[Notices]
[Pages 4335-4336]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-01136]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. DEA-1316]


Importer of Controlled Substances Application: Mylan Inc.

AGENCY: Drug Enforcement Administration, Justice.

ACTION: Notice of application.

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SUMMARY: Mylan 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 
February 22, 2024. Such persons may also file a written request for a 
hearing on the application on or before February 22, 2024.

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

[[Page 4336]]

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 December 5, 2023, Mylan Inc., 3711 Collins Ferry 
Road, Morgantown, West Virginia 26505-2362, 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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Amphetamine.............................    1100  II
Methylphenidate.........................    1724  II
Oxycodone...............................    9143  II
Hydromorphone...........................    9150  II
Methadone...............................    9250  II
Morphine................................    9300  II
Fentanyl................................    9801  II
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    The company plans to import the above controlled substances as bulk 
active pharmaceutical ingredients for internal testing purposes only 
and finished dosage forms for analytical testing and distribution for 
clinical trials to support foreign market participation. 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.

Claude Redd,
Acting Deputy Assistant Administrator.
[FR Doc. 2024-01136 Filed 1-22-24; 8:45 am]
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