Notice2022-23613
Importer of Controlled Substances Application: Mylan Technologies, Inc.
Primary source
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Published
October 31, 2022
Issuing agencies
Justice DepartmentDrug Enforcement Administration
Abstract
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.
Full Text
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<title>Federal Register, Volume 87 Issue 209 (Monday, October 31, 2022)</title>
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[Federal Register Volume 87, Number 209 (Monday, October 31, 2022)]
[Notices]
[Pages 65609-65610]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[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 <a href="https://www.regulations.gov">https://www.regulations.gov</a> 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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>. 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]
BILLING CODE P
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</html>Indexed from Federal Register on October 31, 2022.
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