Bulk Manufacturer of Controlled Substances Application: Navinta LLC, 97070 [2024-28719]

Download as PDF 97070 Federal Register / Vol. 89, No. 235 / Friday, December 6, 2024 / Notices 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 5, 2024, Kinetochem LLC, 96 Market Street, Suite 102, Georgetown, Texas 78626– 3618, applied to be registered as a bulk manufacturer of the following basic class(es) of controlled substance(s): Controlled substance Marihuana .................. Tetrahydrocannabinols. Psilocybin .................. Psilocyn ..................... Drug code Schedule 7360 7370 I I 7437 7438 I I The company plans to bulk manufacture the listed controlled substances as Active Pharmaceutical Ingredients to its customers as well as for research and clinical trials. In reference to drug codes 7360 (Marihuana), and 7370 (Tetrahydrocannabinols) the company plans to bulk manufacture these drug codes as synthetic. No other activities for these drug codes are authorized for this registration. Matthew Strait, Deputy Assistant Administrator. 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 February 4, 2025. Such persons may also file a written request for a hearing on the application on or before February 4, 2025. DATES: 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. ADDRESSES: In accordance with 21 CFR 1301.33(a), this is notice that on October 14, 2024, Navinta LLC, 1499 Lower Ferry Road, Ewing, New Jersey 08618–1414, applied to be registered as a bulk manufacturer of the following basic class(es) of controlled substance(s): SUPPLEMENTARY INFORMATION: Controlled substance Levomethorphan .............. Levorphanol ..................... Remifentanil ..................... Drug code Schedule 9210 9220 9739 II II II [FR Doc. 2024–28715 Filed 12–5–24; 8:45 am] BILLING CODE 4410–09–P The company plans to bulk manufacture the listed controlled substances for validation purposes as part of the Food Administration approval process before distributing to their customers. No other activities for these drug codes are authorized for this registration. DEPARTMENT OF JUSTICE Drug Enforcement Administration [Docket No. DEA–1464] Bulk Manufacturer of Controlled Substances Application: Navinta LLC Drug Enforcement Administration, Justice. ACTION: Notice of application. lotter on DSK11XQN23PROD with NOTICES1 AGENCY: Matthew Strait, Deputy Assistant Administrator. [FR Doc. 2024–28719 Filed 12–5–24; 8:45 am] BILLING CODE P Navinta 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. SUMMARY: VerDate Sep<11>2014 18:02 Dec 05, 2024 Jkt 265001 PO 00000 Frm 00135 Fmt 4703 Sfmt 4703 DEPARTMENT OF JUSTICE Drug Enforcement Administration [Docket No. DEA–1465] Importer of Controlled Substances Application: Organic Standards Solutions International, LLC Drug Enforcement Administration, Justice. ACTION: Notice of application. AGENCY: Organic Standards Solutions International, 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. SUMMARY: 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 January 6, 2025. Such persons may also file a written request for a hearing on the application on or before January 6, 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. 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 November 6, 2024, Organic Standards Solutions International, LLC, 7290 Investment Drive, Unit B, North Charleston, South DATES: E:\FR\FM\06DEN1.SGM 06DEN1

Agencies

[Federal Register Volume 89, Number 235 (Friday, December 6, 2024)]
[Notices]
[Page 97070]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-28719]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. DEA-1464]


Bulk Manufacturer of Controlled Substances Application: Navinta 
LLC

AGENCY: Drug Enforcement Administration, Justice.

ACTION: Notice of application.

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SUMMARY: Navinta 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 
February 4, 2025. Such persons may also file a written request for a 
hearing on the application on or before February 4, 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 October 14, 2024, Navinta LLC, 1499 Lower Ferry Road, 
Ewing, New Jersey 08618-1414, applied to be registered as a bulk 
manufacturer of the following basic class(es) of controlled 
substance(s):

------------------------------------------------------------------------
                                           Drug
          Controlled substance             code          Schedule
------------------------------------------------------------------------
Levomethorphan..........................    9210  II
Levorphanol.............................    9220  II
Remifentanil............................    9739  II
------------------------------------------------------------------------

    The company plans to bulk manufacture the listed controlled 
substances for validation purposes as part of the Food Administration 
approval process before distributing to their customers. No other 
activities for these drug codes are authorized for this registration.

Matthew Strait,
Deputy Assistant Administrator.
[FR Doc. 2024-28719 Filed 12-5-24; 8:45 am]
BILLING CODE P
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