Bulk Manufacturer of Controlled Substances Application: Veranova, L.P., 8158-8159 [2025-01711]
Download as PDF
8158
Federal Register / Vol. 90, No. 15 / Friday, January 24, 2025 / Notices
Controlled substance
Drug code
khammond on DSK9W7S144PROD with NOTICES
Phencyclidine .........................................................................................................................................................................
4-Anilino-N-phenethyl-4-piperidine (ANPP) ...........................................................................................................................
Norfentanyl (N-phenyl-N-(piperidin-4-yl)propionamide) .........................................................................................................
Phenylacetone .......................................................................................................................................................................
1-Piperidinocyclohexanecarbonitrile ......................................................................................................................................
Alphaprodine ..........................................................................................................................................................................
Anileridine ..............................................................................................................................................................................
Cocaine ..................................................................................................................................................................................
Codeine .................................................................................................................................................................................
Etorphine HCl ........................................................................................................................................................................
Dihydrocodeine ......................................................................................................................................................................
Oxycodone .............................................................................................................................................................................
Hydromorphone .....................................................................................................................................................................
Diphenoxylate ........................................................................................................................................................................
Ecgonine ................................................................................................................................................................................
Ethylmorphine ........................................................................................................................................................................
Hydrocodone .........................................................................................................................................................................
Levomethorphan ....................................................................................................................................................................
Levorphanol ...........................................................................................................................................................................
Isomethadone ........................................................................................................................................................................
Meperidine .............................................................................................................................................................................
Meperidine intermediate-A ....................................................................................................................................................
Meperidine intermediate-B ....................................................................................................................................................
Meperidine intermediate-C ....................................................................................................................................................
Metazocine ............................................................................................................................................................................
Oliceridine (N-[(3-methoxythiophen-2-yl)methyl] ({2-[(9R)-9-(pyridin-2-yl)-6-oxaspiro [4.5]decan-9-yl]ethyl{time})amine
fumarate).
Methadone .............................................................................................................................................................................
Methadone intermediate (4-cyano-2-dimethylamino-4,4-diphenylbutane .............................................................................
Metopon .................................................................................................................................................................................
Dextropropoxyphene, bulk (non-dosage forms) ....................................................................................................................
Morphine ................................................................................................................................................................................
Oripavine ...............................................................................................................................................................................
Thebaine ................................................................................................................................................................................
Dihydroetorphine ...................................................................................................................................................................
Levo-alphacetylmethadol .......................................................................................................................................................
Poppy Straw ..........................................................................................................................................................................
Oxymorphone ........................................................................................................................................................................
Noroxymorphone ...................................................................................................................................................................
Phenazocine ..........................................................................................................................................................................
Thiafentanil ............................................................................................................................................................................
Piminodine .............................................................................................................................................................................
Racemethorphan ...................................................................................................................................................................
Racemorphan ........................................................................................................................................................................
Alfentanil ................................................................................................................................................................................
Remifentanil ...........................................................................................................................................................................
Sufentanil ...............................................................................................................................................................................
Carfentanil .............................................................................................................................................................................
Tapentadol .............................................................................................................................................................................
Bezitramide ............................................................................................................................................................................
Fentanyl .................................................................................................................................................................................
Moramide-intermediate ..........................................................................................................................................................
The company plans to import the
listed controlled substances for
distribution for analytical testing
purposes. 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-
VerDate Sep<11>2014
16:21 Jan 23, 2025
Jkt 265001
approved finished dosage forms for
commercial sale.
Matthew Strait,
Deputy Assistant Administrator.
PO 00000
7471
8333
8366
8501
8603
9010
9020
9041
9050
9059
9120
9143
9150
9170
9180
9190
9193
9210
9220
9226
9230
9232
9233
9234
9240
9245
II
II
II
II
II
II
II
II
II
II
II
II
II
II
II
II
II
II
II
II
II
II
II
II
II
II
9250
9254
9260
9273
9300
9330
9333
9334
9648
9650
9652
9668
9715
9729
9730
9732
9733
9737
9739
9740
9743
9780
9800
9801
9802
II
II
II
II
II
II
II
II
II
II
II
II
II
II
II
II
II
II
II
II
II
II
II
II
II
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA–1479]
[FR Doc. 2025–01707 Filed 1–23–25; 8:45 am]
BILLING CODE P
Schedule
Bulk Manufacturer of Controlled
Substances Application: Veranova,
L.P.
Drug Enforcement
Administration, Justice.
ACTION: Notice of application.
AGENCY:
Veranova, L.P., has applied to
be registered as a bulk manufacturer of
basic class(es) of controlled
substance(s). Refer to SUPPLEMENTARY
SUMMARY:
Frm 00044
Fmt 4703
Sfmt 4703
E:\FR\FM\24JAN1.SGM
24JAN1
Federal Register / Vol. 90, No. 15 / Friday, January 24, 2025 / Notices
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 March 25, 2025. Such
persons may also file a written request
for a hearing on the application on or
before March 25, 2025.
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 November 25, 2024,
Veranova, L.P., 25 Patton Road,
Pharmaceutical Service, Devens,
Massachusetts 01434–3803, applied to
be registered as a bulk manufacturer of
the following basic class(es) of
controlled substance(s):
Controlled substance
khammond on DSK9W7S144PROD with NOTICES
Lysergic Acid
Diethylamide.
Amphetamine ..................
Methylphenidate ..............
Nabilone ..........................
Hydrocodone ...................
Levorphanol .....................
Thebaine ..........................
Alfentanil ..........................
Remifentanil .....................
Sufentanil .........................
Drug
code
Schedule
7315
I
1100
1724
7379
9193
9220
9333
9737
9739
9740
II
II
II
II
II
II
II
II
II
The company plans to bulk
manufacture the listed controlled
substances in order to support the
manufacturing and analytical testing
activities at its other Drug Enforcement
Administration-registered
manufacturing facility. No other
activities for these drug codes are
authorized for this registration.
DEPARTMENT OF JUSTICE
DEPARTMENT OF JUSTICE
Notice of Lodging of Proposed
Consent Decree
Notice of Lodging of Proposed
Consent Decree Under the
Comprehensive Environmental
Response, Compensation, and Liability
Act
In accordance with Departmental
Policy, 28 CFR 50.7, notice is hereby
given that a proposed Consent Decree in
United States v. Elmore Sand & Gravel,
Inc., Case No. 2:25–cv–60, was lodged
with the United States District Court for
the Middle District of Alabama on
January 17, 2025.
This proposed Consent Decree
concerns a complaint filed by the
United States against Defendant Elmore
Sand & Gravel, Inc., pursuant to Section
309 of the Clean Water Act, 33 U.S.C.
1319, to obtain injunctive and other
appropriate relief from the Defendant
for violating the Clean Water Act by
discharging pollutants without
authorization into waters of the United
States. The proposed Consent Decree
resolves these allegations by requiring
the Defendant to perform mandatory
injunctive relief (including stabilization,
remediation, wastewater management,
enhancement, mitigation, and
preservation measures) and subjects the
Defendant to other appropriate relief.
The Department of Justice will accept
written comments relating to this
proposed Consent Decree for thirty (30)
days from the date of publication of this
Notice. Please address comments by
mail to Andrew Doyle and Martin
McDermott, United States Department
of Justice, Environment and Natural
Resources Division, Environmental
Defense Section, Post Office Box 7611,
Washington, DC 20044, or by email to
pubcomment_eds.enrd@usdoj.gov and
refer to United States v. Elmore Sand &
Gravel, Inc., DJ No. 90–5–1–1–21374.
The proposed Consent Decree may be
examined at the Clerk’s Office, United
States District Court for the Middle
District of Alabama, One Church Street,
Montgomery, AL 36104. In addition, the
proposed Consent Decree may be
examined electronically at https://
www.justice.gov/enrd/consent-decrees.
Cherie Rogers,
Assistant Section Chief, Environmental
Defense Section, Environment and Natural
Resources Division, United States Department
of Justice.
On January, 17, 2025, the Department
of Justice lodged a proposed Consent
Decree with the United States District
Court for the Northern District of
California, in the lawsuit entitled
United States of America, ex. Rel.,
Arthur R. Jahr, III et al., Anthony Smith
& Donald K. Wadsworth et al. v. Tetra
Tech EC Inc, Civil Action No. 3:13–cv–
3835 JD, pertaining to the Hunters Point
Naval Shipyard Superfund Site in San
Francisco, California.
The Consent Decree resolves the Fifth
Cause of Action set forth in the United
States’ Second Amended Complaint
filed in the above referenced matter
(‘‘CERCLA Claim’’). The CERCLA Claim
asserts that response action contractor,
Tetra Tech EC (‘‘TtEC’’), is liable under
Section 107(a) of CERCLA as both an
operator of the facility at the time of the
disposal of a hazardous substance, and
as a transporter for disposal of a
hazardous substance at the site. TtEC
signed the consent decree. TtEC will
pay $40 million in response costs. In
return, the United States agrees not to
sue TtEC under sections 106 and 107 of
CERCLA. The Consent Decree also
resolves TtEC’s counterclaim against
Navy pursuant to Section 113(f) of
CERCLA seeking contribution, equitable
allocation of response costs incurred at
the site, equitable contribution,
equitable indemnity and declaratory
relief.
The publication of this notice opens
a period for public comment on the
Consent Decree. Comments should be
addressed to the Assistant Attorney
General, Environment and Natural
Resources Division, and should refer to
United States of America, ex. Rel.,
Arthur R. Jahr, III et al., Anthony Smith
& Donald K. Wadsworth et al. v. Tetra
Tech EC Inc, D.J. Ref. No. 90–11–3–
12345. 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.
[FR Doc. 2025–01668 Filed 1–23–25; 8:45 am]
BILLING CODE P
Matthew Strait,
Deputy Assistant Administrator.
By mail .........
[FR Doc. 2025–01711 Filed 1–23–25; 8:45 am]
BILLING CODE P
VerDate Sep<11>2014
16:21 Jan 23, 2025
Jkt 265001
8159
PO 00000
Frm 00045
Fmt 4703
Sfmt 4703
E:\FR\FM\24JAN1.SGM
24JAN1
Agencies
[Federal Register Volume 90, Number 15 (Friday, January 24, 2025)]
[Notices]
[Pages 8158-8159]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2025-01711]
-----------------------------------------------------------------------
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA-1479]
Bulk Manufacturer of Controlled Substances Application: Veranova,
L.P.
AGENCY: Drug Enforcement Administration, Justice.
ACTION: Notice of application.
-----------------------------------------------------------------------
SUMMARY: Veranova, L.P., has applied to be registered as a bulk
manufacturer of basic class(es) of controlled substance(s). Refer to
Supplementary
[[Page 8159]]
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
March 25, 2025. Such persons may also file a written request for a
hearing on the application on or before March 25, 2025.
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 November 25, 2024, Veranova, L.P., 25 Patton Road,
Pharmaceutical Service, Devens, Massachusetts 01434-3803, applied to be
registered as a bulk manufacturer of the following basic class(es) of
controlled substance(s):
------------------------------------------------------------------------
Drug
Controlled substance code Schedule
------------------------------------------------------------------------
Lysergic Acid Diethylamide.............. 7315 I
Amphetamine............................. 1100 II
Methylphenidate......................... 1724 II
Nabilone................................ 7379 II
Hydrocodone............................. 9193 II
Levorphanol............................. 9220 II
Thebaine................................ 9333 II
Alfentanil.............................. 9737 II
Remifentanil............................ 9739 II
Sufentanil.............................. 9740 II
------------------------------------------------------------------------
The company plans to bulk manufacture the listed controlled
substances in order to support the manufacturing and analytical testing
activities at its other Drug Enforcement Administration-registered
manufacturing facility. No other activities for these drug codes are
authorized for this registration.
Matthew Strait,
Deputy Assistant Administrator.
[FR Doc. 2025-01711 Filed 1-23-25; 8:45 am]
BILLING CODE P