[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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