Bulk Manufacturer of Controlled Substances Application: AMPAC Fine Chemicals Virginia LLC, 46907-46908 [2024-11790]
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Federal Register / Vol. 89, No. 105 / Thursday, May 30, 2024 / Notices
approved finished dosage forms for
commercial sale.
Chemtos, LLC 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.
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 July 29, 2024. Such persons
may also file a written request for a
hearing on the application on or before
July 29, 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
SUMMARY:
Marsha L. Ikner,
Acting Deputy Assistant Administrator.
[FR Doc. 2024–11794 Filed 5–29–24; 8:45 am]
BILLING CODE 4410–09–P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA–1375]
Bulk Manufacturer of Controlled
Substances Application: Chemtos,
LLC
Drug Enforcement
Administration, Justice.
AGENCY:
ACTION:
Notice of application.
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.
In
accordance with 21 CFR 1301.33(a), this
is notice that on April 10, 2024,
Chemtos, LLC, 16713 Picadilly Court,
Round Rock, Texas 78664–8544,
applied to be registered as a bulk
manufacturer of the following basic
class(es) of controlled substance(s):
SUPPLEMENTARY INFORMATION:
Controlled substance
3-methylmethcathinone (2-(methylamino)-1-(3- methylphenyl)propan-1-one) ...............................................................................
Etizolam (4-(2-chlorophenyl)-2-ethyl-9-methyl-6H-thieno[3,2-f][1,2,4]triazolo[4,3-a][1,4]diazepine ...............................................
Flualprazolam (8-chloro-6-(2-fluorophenyl)-1-methyl-4H-benzo[f][1,2,4]triazolo[4,3-a][1,4]diazepine) ..........................................
Clonazolam (6-(2-chlorophenyl)-1-methyl-8-nitro-4H-benzo[f][1,2,4]triazolo[4,3-a][1,4]diazepin ...................................................
Flubromazolam (8-bromo-6-(2-fluorophenyl)-1-methyl-4H-benzo[f][1,2,4]triazolo[4,3-a][1,4]diazepine .........................................
Diclazepam (7-chloro-5-(2-chloro-5-(2-chlorophenyl)-1- methyl-1,3-dihydro-2H-benzo[e][1,4]diazepin-2-one ..............................
ADB-BUTINACA (N-(1-amino-3,3-dimethyl-1-oxobutan-2-yl)-1-butyl-1H-indazole-3-carboxamide) ..............................................
MDMB-4en-PINACA (methyl 3,3-dimethyl-2-(1-(pent-4- en-1-yl)-1H-indazole-3-carboxamido)butanoate) ...................................
4F-MDMB-BUTICA (methyl 2-[[1-(4-fluorobutyl)indole-3- carbonyl]amino]-3,3-dimethyl-butanoate ..............................................
ADB-4en-PINACA (N-(1-amino-3,3-dimethyl-1-oxobutan-2-yl)-1-(pent-4-en-1-yl)-1H-indazole-3- carboxamide) .........................
CUMYL-PEGACLONE (5-pentyl-2-(2-phenylpropan-2- yl)pyrido[4,3-b]indol-1-one) .....................................................................
5F-EDMB-PICA (ethyl 2-[[1-(5-fluorophentyl)indole-3- carbonyl]amino]-3,3-dimethyl-butanoate ..................................................
MMB-FUBICA (methyl 2-(1-(4-fluorobenzyl)-1H-indole-3-carboxamido)-3-methyl butanoate .......................................................
a-PiHP (4-methyl-1-phenyl-2-(pyrrolidin-1-yl)pentan-1-one) ..........................................................................................................
The company plans to bulk
manufacture the listed controlled
substances for sale as reference
standards to their customers. No other
activities for these drug codes are
authorized for this registration.
Marsha L. Ikner,
Acting Deputy Assistant Administrator.
[FR Doc. 2024–11816 Filed 5–29–24; 8:45 am]
BILLING CODE P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
ddrumheller on DSK120RN23PROD with NOTICES1
[Docket No. DEA–1371]
Bulk Manufacturer of Controlled
Substances Application: AMPAC Fine
Chemicals Virginia LLC
Drug Enforcement
Administration, Justice.
ACTION: Notice of application.
AGENCY:
AMPAC Fine Chemicals
Virginia LLC has applied to be
SUMMARY:
VerDate Sep<11>2014
20:03 May 29, 2024
Jkt 262001
registered as a bulk manufacturer 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 July 29, 2024. Such persons
may also file a written request for a
hearing on the application on or before
July 29, 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
PO 00000
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Drug
code
Schedule
1259
2780
2785
2786
2788
2789
7027
7090
7091
7092
7093
7094
7095
7551
I
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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 December 22, 2023,
AMPAC Fine Chemicals Virginia LLC,
2820 Normandy Drive, Petersburg,
Virginia 23805–2380, applied to be
registered as a bulk manufacturer of the
following basic class(es) of controlled
substance(s):
Controlled substance
Amphetamine ..................
Lisdexamfetamine ...........
I
Drug
code
Schedule
1100
1205
II
II
I
The company plans to bulk
manufacture the above listed controlled
substances for the internal use as
intermediates or for distribution to its
customers. No other activities for these
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Federal Register / Vol. 89, No. 105 / Thursday, May 30, 2024 / Notices
8701 Morrissette Drive, Springfield,
Virginia 22152.
SUPPLEMENTARY INFORMATION: In
accordance with 21 CFR 1301.34(a), this
is notice that on March 1, 2024, Skalar
Pharma, LLC, SR 53 KM 82 Guayama,
Guayama, Puerto Rico 00784, applied to
be registered as an importer of the
following basic class(es) of controlled
substance(s):
drug codes are authorized for this
registration.
Marsha L. Ikner,
Acting Deputy Assistant Administrator.
[FR Doc. 2024–11790 Filed 5–29–24; 8:45 am]
BILLING CODE P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
Drug
code
Controlled substance
[Docket No. DEA–1370]
Phenylacetone .................
Importer of Controlled Substances
Application: Skalar Pharma, LLC
Drug Enforcement
Administration, Justice.
ACTION: Notice of application.
AGENCY:
Skalar Pharma, LLC 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 July 1, 2024. Such persons
may also file a written request for a
hearing on the application on or before
July 1, 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,
ddrumheller on DSK120RN23PROD with NOTICES1
SUMMARY:
VerDate Sep<11>2014
20:03 May 29, 2024
Jkt 262001
Schedule
I 8501 III
The company plans to import the
listed controlled substance to be used in
the manufacturing process for other
controlled substances. 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.
and CWA section 311 response costs
incurred by the United States; (ii) pay a
civil penalty of $15 million for violating
CWA sections 301 and 311; (iii)
establish a $25 million community
health program for qualifying members
of the public impacted by the
derailment; (iv) implement an array of
specified rail safety procedures; (v)
develop and adopt programs for
coordination of rail track restoration and
vent and burn procedures; (vi)
implement a $6 million local waterways
remediation plan; (vii) pay $175,000 for
natural resource damages; and (viii)
implement compliance and future
monitoring requirements in the various
work plans approved under EPA’s
Unilateral Administrative Orders and
CWA Order.
BILLING CODE P
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 The State of Ohio and The
United States of America v. Norfolk
Southern Railway Company, et al., D.J.
Ref. No. 90–11–3–12792. All comments
must be submitted no later than 30 days
after the publication date of this notice.
Comments may be submitted either by
email or by mail:
DEPARTMENT OF JUSTICE
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.
Marsha L. Ikner,
Acting Deputy Assistant Administrator.
[FR Doc. 2024–11793 Filed 5–29–24; 8:45 am]
Notice of Lodging of Proposed
Consent Decree Under the
Comprehensive Environmental
Response, Compensation, and Liability
Act and the Clean Water Act
On May 23, 2024, the Department of
Justice lodged a proposed Consent
Decree with the United States District
Court for the Northern District of Ohio
in the lawsuit entitled The State of Ohio
and The United States of America v.
Norfolk Southern Railway Company, et
al., Case No. 4:23–cv–00517.
The proposed Consent Decree settles
claims brought by the United States
under sections 309 and 311 of the Clean
Water Act (‘‘CWA’’), 42 U.S.C. 1311 and
1321 and sections 107 and 113 of the
Comprehensive Environmental
Response, Compensation, and Liability
Act (‘‘CERCLA’’), 42 U.S.C. 9607 and
9613, against Norfolk Southern Railway
Company and Norfolk Southern
Corporation (‘‘Defendants’’) related to
the February 3, 2023 train derailment in
East Palestine, Ohio. The proposed
Consent Decree would require Norfolk
Southern: (i) to reimburse all CERCLA
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By mail .........
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
consent decree, you may request
assistance by email or by mail to the
addresses provided above for submitting
comments.
Laura Thoms,
Assistant Section Chief, Environmental
Enforcement Section, Environment and
Natural Resources Division.
[FR Doc. 2024–11862 Filed 5–29–24; 8:45 am]
BILLING CODE 4410–15–P
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]]>Agencies
[Federal Register Volume 89, Number 105 (Thursday, May 30, 2024)]
[Notices]
[Pages 46907-46908]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-11790]
-----------------------------------------------------------------------
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA-1371]
Bulk Manufacturer of Controlled Substances Application: AMPAC
Fine Chemicals Virginia LLC
AGENCY: Drug Enforcement Administration, Justice.
ACTION: Notice of application.
-----------------------------------------------------------------------
SUMMARY: AMPAC Fine Chemicals Virginia LLC 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.
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
July 29, 2024. Such persons may also file a written request for a
hearing on the application on or before July 29, 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.
SUPPLEMENTARY INFORMATION: In accordance with 21 CFR 1301.33(a), this
is notice that on December 22, 2023, AMPAC Fine Chemicals Virginia LLC,
2820 Normandy Drive, Petersburg, Virginia 23805-2380, applied to be
registered as a bulk manufacturer of the following basic class(es) of
controlled substance(s):
------------------------------------------------------------------------
Drug
Controlled substance code Schedule
------------------------------------------------------------------------
Amphetamine............................. 1100 II
Lisdexamfetamine........................ 1205 II
------------------------------------------------------------------------
The company plans to bulk manufacture the above listed controlled
substances for the internal use as intermediates or for distribution to
its customers. No other activities for these
[[Page 46908]]
drug codes are authorized for this registration.
Marsha L. Ikner,
Acting Deputy Assistant Administrator.
[FR Doc. 2024-11790 Filed 5-29-24; 8:45 am]
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