Importer of Controlled Substances Application: Lyndra Therapeutics, 19327-19328 [2023-06648]
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19327
Federal Register / Vol. 88, No. 62 / Friday, March 31, 2023 / Notices
The company plans to bulk
manufacture the listed controlled
substances for the production of active
pharmaceutical ingredients (API) and
analytical reference standards for sale to
its customers. The company plans to
manufacture the above listed controlled
substances as clinical trial and starting
materials to make compounds for
distribution to its customers. No other
activities for these drug codes are
authorized for this registration.
Matthew Strait,
Deputy Assistant Administrator.
[FR Doc. 2023–06687 Filed 3–30–23; 8:45 am]
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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 February 22, 2023,
PerkinElmer, Inc., 120 East Dedham
Street, Boston, Massachusetts 02118–
2852, applied to be registered as an
importer of the following basic class(es)
of controlled substance(s):
DEPARTMENT OF JUSTICE
Controlled substance
Drug Enforcement Administration
Lysergic Acid
Diethylamide.
Thebaine .......................
[Docket No. DEA–1167]
Importer of Controlled Substances
Application: PerkinElmer, Inc.
Drug Enforcement
Administration, Justice.
ACTION: Notice of application.
AGENCY:
PerkinElmer, 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 May 1, 2023. Such persons
may also file a written request for a
hearing on the application on or before
May 1, 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
ddrumheller on DSK120RN23PROD with NOTICES1
SUMMARY:
VerDate Sep<11>2014
17:54 Mar 30, 2023
Jkt 259001
Drug
code
Schedule
7315
I
9333
II
The company plans to import the
listed controlled substances for bulk
manufacturing into radioactive
formulations for sale to its customers for
research purposes. Drug code 9333
(Thebaine) will be used to import the
Thebaine derivative Diprenorphine. 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).
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. 2023–06696 Filed 3–30–23; 8:45 am]
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
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 May 30, 2023. Such persons
may also file a written request for a
hearing on the application on or before
May 30, 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.
SUPPLEMENTARY INFORMATION: In
accordance with 21 CFR 1301.33(a), this
is notice that on March 3, 2023, ANI
Pharmaceuticals, Inc., 70 Lake Drive,
East Windsor, New Jersey 08520,
applied to be registered as a bulk
manufacturer of the following basic
class(es) of controlled substance(s):
DATES:
Controlled substance
Psilocybin .....................
Levorphanol ..................
Drug
code
7437
9220
Schedule
I
I
The company plans to bulk
manufacture the listed controlled
substances for the internal use or for
sale to its customers. No other activities
for these drug codes are authorized for
this registration.
Matthew Strait,
Deputy Assistant Administrator.
[FR Doc. 2023–06700 Filed 3–30–23; 8:45 am]
[Docket No. DEA–1173]
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Bulk Manufacturer of Controlled
Substances Application: ANI
Pharmaceuticals, Inc.
DEPARTMENT OF JUSTICE
Drug Enforcement
Administration, Justice.
ACTION: Notice of application.
Drug Enforcement Administration
ANI Pharmaceuticals, Inc. has
applied to be registered as a bulk
manufacturer of basic class(es) of
controlled substance(s). Refer to
SUPPLEMENTARY INFORMATION listed
below for further drug information.
Importer of Controlled Substances
Application: Lyndra Therapeutics
AGENCY:
SUMMARY:
PO 00000
Frm 00090
Fmt 4703
Sfmt 4703
[Docket No. DEA–1165]
Drug Enforcement
Administration, Justice.
ACTION: Notice of application.
AGENCY:
E:\FR\FM\31MRN1.SGM
31MRN1
19328
Federal Register / Vol. 88, No. 62 / Friday, March 31, 2023 / Notices
Lyndra Therapeutics 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 May 1, 2023. Such persons
may also file a written request for a
hearing on the application on or before
May 1, 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 February 20, 2023,
Lyndra Therapeutics, 65 Grove Street
Suite 301, Watertown, Massachusetts
02472 applied to be registered as an
importer of the following basic class(es)
of controlled substance(s):
ddrumheller on DSK120RN23PROD with NOTICES1
SUMMARY:
Controlled substance
Drug
code
Schedule
Methadone ................
9250
II
The company plans to import the
above controlled substance for use in
preclinical research and human 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
VerDate Sep<11>2014
17:54 Mar 30, 2023
Jkt 259001
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. 2023–06648 Filed 3–30–23; 8:45 am]
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DEPARTMENT OF JUSTICE
Notice of Lodging of Proposed
Consent Decree Under the Clean Air
Act
On March 27, 2023, 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. Matador Production
Company, Civil Action No. 23–cv–
00260.
In this action, the United States, on
behalf of the U.S. Environmental
Protection Agency, and the New Mexico
Environment Department filed a
complaint alleging that Matador
Production Company (‘‘Defendant’’)
violated the Clean Air Act, the New
Mexico Air Quality Control Act, and the
implementing regulations at 25 of
Defendant’s oil and natural gas
production facilities in New Mexico by,
inter alia, failing to comply with
applicable emissions standards for VOC,
NOX and CO and failing to submit a
Notice of Intent or register for a General
Construction Permit as required. 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 $1,150,000 (of which $650,000 is to
be paid to the United States and
$500,000 is to be paid to the State of
New Mexico) and to spend at least
$1,250,000 on a diesel emission
reduction Supplemental Environmental
Project (‘‘SEP’’) and at least $500,000 on
a state aerial emission monitoring SEP.
In addition, the settlement requires
the Defendant to ensure ongoing
compliance with all applicable
regulatory requirements at all 255 of its
oil and natural gas production facilities
in New Mexico. Specifically, the
settlement requires the Defendant to
identify and remedy any compromised
PO 00000
Frm 00091
Fmt 4703
Sfmt 9990
equipment, undertake a design analysis
to ensure adequate design and sizing of
the vapor control system, install and
operate extensive monitoring systems,
implement a robust inspection and
maintenance program, 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. Matador
Production Company, D.J. Ref. No. 90–
5–2–1–12297. 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 .........
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.
We will provide a paper copy of the
proposed consent decree upon written
request and payment of reproduction
costs. Please mail your request and
payment to: Consent Decree Library,
U.S. DOJ–ENRD, P.O. Box 7611,
Washington, DC 20044–7611.
Please enclose a check or money order
for $33.75 (25 cents per page
reproduction cost) payable to the United
States Treasury.
Thomas Carroll,
Assistant Section Chief, Environmental
Enforcement Section, Environment and
Natural Resources Division.
[FR Doc. 2023–06651 Filed 3–30–23; 8:45 am]
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]]>Agencies
[Federal Register Volume 88, Number 62 (Friday, March 31, 2023)]
[Notices]
[Pages 19327-19328]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-06648]
-----------------------------------------------------------------------
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA-1165]
Importer of Controlled Substances Application: Lyndra
Therapeutics
AGENCY: Drug Enforcement Administration, Justice.
ACTION: Notice of application.
-----------------------------------------------------------------------
[[Page 19328]]
SUMMARY: Lyndra Therapeutics 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
May 1, 2023. Such persons may also file a written request for a hearing
on the application on or before May 1, 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 February 20, 2023, Lyndra Therapeutics, 65 Grove
Street Suite 301, Watertown, Massachusetts 02472 applied to be
registered as an importer of the following basic class(es) of
controlled substance(s):
------------------------------------------------------------------------
Controlled substance Drug code Schedule
------------------------------------------------------------------------
Methadone............................ 9250 II
------------------------------------------------------------------------
The company plans to import the above controlled substance for use
in preclinical research and human 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). 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. 2023-06648 Filed 3-30-23; 8:45 am]
BILLING CODE P
