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]


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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
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