Importer of Controlled Substances Application: Halo Pharmaceutical Inc., 84624-84625 [2024-24560]
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84624
Federal Register / Vol. 89, No. 205 / Wednesday, October 23, 2024 / Notices
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. 2024–24570 Filed 10–22–24; 8:45 am]
BILLING CODE 4410–09–P
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 8, 2024, 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):
DEPARTMENT OF JUSTICE
Drug
code
Controlled substance
Drug Enforcement Administration
Methylphenidate .............
Fentanyl ..........................
[Docket No. DEA–1441]
Importer of Controlled Substances
Application: Mylan Technologies Inc
Drug Enforcement
Administration, Justice.
ACTION: Notice of application.
AGENCY:
Mylan Technologies Inc 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 22, 2024. Such
persons may also file a written request
for a hearing on the application on or
before November 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
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
khammond on DSKJM1Z7X2PROD with NOTICES
SUMMARY:
VerDate Sep<11>2014
18:48 Oct 22, 2024
Jkt 265001
I
1724
9801
Schedule
II
III
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.
Matthew Strait,
Deputy Assistant Administrator.
[FR Doc. 2024–24557 Filed 10–22–24; 8:45 am]
BILLING CODE P
listed below for further drug
information.
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 22, 2024. Such
persons may also file a written request
for a hearing on the application on or
before November 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
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 September 11, 2024,
Halo Pharmaceutical Inc., 30 North
Jefferson Road, Whippany, New Jersey
07981–1030, applied to be registered as
an importer of the following basic
class(es) of controlled substance(s):
DATES:
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
Controlled substance
Drug
code
Schedule
7437
I
[Docket No. DEA–1440]
Psilocybin .......................
Importer of Controlled Substances
Application: Halo Pharmaceutical Inc.
The company plans to import the
listed controlled substance to support
formulation development and use in
clinical trials. 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).
Drug Enforcement
Administration, Justice.
ACTION: Notice of application.
AGENCY:
Halo Pharmaceutical Inc. to
be registered as an importer of basic
class(es) of controlled substance(s).
Refer to SUPPLEMENTARY INFORMATION
SUMMARY:
PO 00000
Frm 00104
Fmt 4703
Sfmt 4703
E:\FR\FM\23OCN1.SGM
23OCN1
Federal Register / Vol. 89, No. 205 / Wednesday, October 23, 2024 / Notices
Administration, Attn: Administrator,
8701 Morrissette Drive, Springfield,
Virginia 22152.
SUPPLEMENTARY INFORMATION: In
accordance with 21 CFR 1301.34(a), this
is notice that on August 26, 2024, Irvine
Labs, Inc., 7305 Murdy Circle,
Huntington Beach, California 92647–
3533, applied to be registered as an
importer of the following basic class(es)
of controlled substance(s):
Authorization will not extend to the
import of Food and Drug
Administration-approved or nonapproved finished dosage forms for
commercial sale.
Matthew Strait,
Deputy Assistant Administrator.
[FR Doc. 2024–24560 Filed 10–22–24; 8:45 am]
BILLING CODE 4410–09–P
DEPARTMENT OF JUSTICE
Controlled substance
Drug Enforcement Administration
[Docket No. DEA–1439]
Importer of Controlled Substances
Application: Irvine Labs, Inc.
Drug Enforcement
Administration, Justice.
ACTION: Notice of application.
AGENCY:
Irvine Labs, 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 22, 2024. Such
persons may also file a written request
for a hearing on the application on or
before November 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
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: DEAFederal
Register Representative/DPW, 8701
Morrissette Drive, Springfield, Virginia
22152. All requests for a hearing should
also be sent to: Drug Enforcement
khammond on DSKJM1Z7X2PROD with NOTICES
SUMMARY:
VerDate Sep<11>2014
18:48 Oct 22, 2024
Jkt 265001
Lysergic acid
diethylamide.
Marihuana Extract ..........
Marihuana .......................
Tetrahydrocannabinols ...
Mescaline .......................
Peyote ............................
Diethyltryptamine ............
Dimethyltryptamine .........
Psilocybin .......................
Psilocyn ..........................
Drug
code
Schedule
7315
I
7350
7360
7370
7381
7415
7434
7435
7437
7438
I
I
I
I
I
I
I
I
I
The company plans to import bulk
substances to support internal research,
clinical trials, analytical purposes, and
distribution to their customers. In
reference to drug codes Marihuana
Extract (7350), Marihuana (7360) and
Tetrahydrocannabinols (7370) the
company plans to import a raw plant
material and extracts. 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.
Matthew Strait,
Deputy Assistant Administrator.
[FR Doc. 2024–24553 Filed 10–22–24; 8:45 am]
BILLING CODE 4410–09–P
Notice of Lodging of Proposed
Consent Decree Under the Clean Air
Act
On October 17, 2024, the Department
of Justice lodged a proposed consent
decree with the United States District
Court for the District of New Mexico in
the lawsuit entitled United States of
America and New Mexico Environment
Department v. Hilcorp Energy Company,
Civil Action No. 1:24-cv-01055.
In this action, the United States, on
behalf of the U.S. Environmental
Protection Agency, and the New Mexico
PO 00000
Frm 00105
Fmt 4703
Sfmt 4703
Environment Department filed a
complaint alleging that Hilcorp Energy
Company (‘‘Defendant’’) violated the
Clean Air Act, the New Mexico Air
Quality Control Act, and the
implementing regulations for 192 well
completions in New Mexico by failing
to comply with applicable well
completion emissions control
requirements, which resulted in excess
emissions of greenhouse gases and
volatile organic compounds. The
complaint seeks an Order enjoining
Defendant from further violating
applicable requirements and requiring
Defendant to remedy, mitigate, and
offset the harm to public health and the
environment caused by the violations
and to pay a civil penalty.
Under the proposed settlement,
Defendant agrees to pay a civil penalty
of $9,400,000 (of which $4,700,000 is to
be paid to the United States and
$4,700,000 is to be paid to the State of
New Mexico).
In addition, the settlement requires
the Defendant to ensure ongoing
compliance with all applicable
regulatory requirements for all of its
future well completions in New Mexico
and hire an independent third party to
verify compliance.
The publication of this notice opens
a period for public comment on the
proposed consent decree. Comments
should be addressed to the Assistant
Attorney General, Environment and
Natural Resources Division, and should
refer to United States and New Mexico
Environment Department v. Hilcorp
Energy Company, D.J. Ref. No. 90–5–2–
1–12445. All comments must be
submitted no later than thirty (30) days
after the publication date of this notice.
Comments may be submitted either by
email or by mail:
To submit
comments:
Send them to:
By email .......
pubcomment-ees.enrd@
usdoj.gov.
Assistant Attorney General,
U.S. DOJ—ENRD, P.O.
Box 7611, Washington, DC
20044–7611.
By mail .........
DEPARTMENT OF JUSTICE
84625
Any comments submitted in writing
may be filed by the United States in
whole or in part on the public court
docket without notice to the commenter.
During the public comment period,
the proposed consent decree may be
examined and downloaded at this
Justice Department website: https://
www.justice.gov/enrd/consent-decrees.
If you require assistance accessing the
proposed consent decree, you may
request assistance by email or by mail
E:\FR\FM\23OCN1.SGM
23OCN1
]]>Agencies
[Federal Register Volume 89, Number 205 (Wednesday, October 23, 2024)]
[Notices]
[Pages 84624-84625]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-24560]
-----------------------------------------------------------------------
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA-1440]
Importer of Controlled Substances Application: Halo
Pharmaceutical Inc.
AGENCY: Drug Enforcement Administration, Justice.
ACTION: Notice of application.
-----------------------------------------------------------------------
SUMMARY: Halo Pharmaceutical Inc. 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 22, 2024. Such persons may also file a written request for a
hearing on the application on or before November 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 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 September 11, 2024, Halo Pharmaceutical Inc., 30
North Jefferson Road, Whippany, New Jersey 07981-1030, applied to be
registered as an importer of the following basic class(es) of
controlled substance(s):
------------------------------------------------------------------------
Drug
Controlled substance code Schedule
------------------------------------------------------------------------
Psilocybin............................. 7437 I
------------------------------------------------------------------------
The company plans to import the listed controlled substance to
support formulation development and use in clinical trials. 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 84625]]
Authorization will not extend to the import of Food and Drug
Administration-approved or non-approved finished dosage forms for
commercial sale.
Matthew Strait,
Deputy Assistant Administrator.
[FR Doc. 2024-24560 Filed 10-22-24; 8:45 am]
BILLING CODE 4410-09-P
