Importer of Controlled Substances Application: Mylan Technologies Inc., 76858 [2023-24573]
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76858
Federal Register / Vol. 88, No. 214 / Tuesday, November 7, 2023 / Notices
III. Sanction
Where, as here, the Government has
established grounds to revoke
Respondent’s registration, the burden
shifts to the registrant to show why he
can be entrusted with the responsibility
carried by a registration. Garret Howard
Smith, M.D., 83 FR 18882, 18910 (2018).
When a registrant has committed acts
inconsistent with the public interest, he
must both accept responsibility and
demonstrate that he has undertaken
corrective measures. Holiday CVS,
L.L.C., dba CVS Pharmacy Nos 219 and
5195, 77 FR 62316, 62339 (2012)
(internal quotations omitted). Trust is
necessarily a fact-dependent
determination based on individual
circumstances; therefore, the Agency
looks at factors such as the acceptance
of responsibility, the credibility of that
acceptance as it relates to the
probability of repeat violations or
behavior, the nature of the misconduct
that forms the basis for sanction, and the
Agency’s interest in deterring similar
acts. See, e.g., Robert Wayne Locklear,
M.D., 86 FR 33738, 33746 (2021).
Here, although Respondent initially
requested a hearing, he withdrew his
hearing request and did not otherwise
avail himself of the opportunity to
refute the Government’s case. As such,
Respondent has made no
representations as to his future
compliance with the CSA nor made any
demonstration that he can be entrusted
with registration. In fact, despite having
already been subject to state action and
a Federal citation in 2017 and thus put
on notice of the impropriety of his
actions, Respondent failed to change his
ways and continued to commit much of
the same misconduct. Moreover, the
evidence presented by the Government
clearly shows that Respondent violated
the CSA, further indicating that
Respondent cannot be entrusted.
Accordingly, the Agency will order the
revocation of Respondent’s registration.
khammond on DSKJM1Z7X2PROD with NOTICES
Order
Pursuant to 28 CFR 0.100(b) and the
authority vested in me by 21 U.S.C.
824(a), I hereby revoke DEA Certificate
of Registration No. AK7830640 issued to
Jagjit Kaleka, D.V.M. Further, pursuant
to 28 CFR 0.100(b) and the authority
vested in me by 21 U.S.C. 823(g)(1), I
hereby deny any pending applications
of Jagjit Kaleka, D.V.M., to renew or
modify this registration, as well as any
other pending application of Jagjit
Kaleka, D.V.M., for additional
registration in Wisconsin. This Order is
effective December 7, 2023.
VerDate Sep<11>2014
16:30 Nov 06, 2023
Jkt 262001
Signing Authority
This document of the Drug
Enforcement Administration was signed
on October 31, 2023, by Administrator
Anne Milgram. That document with the
original signature and date is
maintained by DEA. For administrative
purposes only, and in compliance with
requirements of the Office of the Federal
Register, the undersigned DEA Federal
Register Liaison Officer has been
authorized to sign and submit the
document in electronic format for
publication, as an official document of
DEA. This administrative process in no
way alters the legal effect of this
document upon publication in the
Federal Register.
Heather Achbach,
Federal Register Liaison Officer, Drug
Enforcement Administration.
[FR Doc. 2023–24524 Filed 11–6–23; 8:45 am]
BILLING CODE 4410–09–P
DEPARTMENT OF JUSTICE
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 5, 2023, 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)
Drug
code
Controlled substance
Drug Enforcement Administration
Fentanyl ........................
Methylphenidate ...........
[Docket No. DEA–1285]
Importer of Controlled Substances
Application: Mylan Technologies Inc.
Drug Enforcement
Administration, Justice.
ACTION: Notice of application.
AGENCY:
Mylan Technologies Inc. as
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 December 7, 2023. Such
persons may also file a written request
for a hearing on the application on or
before December 7, 2023.
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
SUMMARY:
PO 00000
Frm 00140
Fmt 4703
Sfmt 4703
I
9801
1724
Schedule
II
I II
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 to
foreign markets. No other activities for
these drug codes are 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 nonapproved finished dosage forms for
commercial sale.
Claude Redd,
Acting Deputy Assistant Administrator.
[FR Doc. 2023–24573 Filed 11–6–23; 8:45 am]
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DEPARTMENT OF JUSTICE
Notice of Lodging of Proposed
Modification to Consent Decree Under
the Clean Water Act
On October 25, 2023, the Department
of Justice lodged a proposed a Material
Modification to the Consent Decrees’
Wet Weather Improvement Program
(‘‘Modification’’) with the United States
District Court for the Southern District
E:\FR\FM\07NON1.SGM
07NON1
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[Federal Register Volume 88, Number 214 (Tuesday, November 7, 2023)]
[Notices]
[Page 76858]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-24573]
-----------------------------------------------------------------------
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA-1285]
Importer of Controlled Substances Application: Mylan Technologies
Inc.
AGENCY: Drug Enforcement Administration, Justice.
ACTION: Notice of application.
-----------------------------------------------------------------------
SUMMARY: Mylan Technologies Inc. as 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
December 7, 2023. Such persons may also file a written request for a
hearing on the application on or before December 7, 2023.
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 5, 2023, 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)
------------------------------------------------------------------------
Drug
Controlled substance code Schedule
------------------------------------------------------------------------
Fentanyl............................... 9801 II
Methylphenidate........................ 1724 II
------------------------------------------------------------------------
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 to foreign markets. No
other activities for these drug codes are 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. 2023-24573 Filed 11-6-23; 8:45 am]
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