Notice2024-28719
Bulk Manufacturer of Controlled Substances Application: Navinta LLC
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
December 6, 2024
Issuing agencies
Justice DepartmentDrug Enforcement Administration
Abstract
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.
Full Text
<html>
<head>
<title>Federal Register, Volume 89 Issue 235 (Friday, December 6, 2024)</title>
</head>
<body><pre>
[Federal Register Volume 89, Number 235 (Friday, December 6, 2024)]
[Notices]
[Page 97070]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2024-28719]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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 <a href="https://www.regulations.gov">https://www.regulations.gov</a> 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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>. 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
</pre></body>
</html>Indexed from Federal Register on December 6, 2024.
This is legal information, not legal advice. Laws vary by jurisdiction and change frequently. Always verify current law with official sources and consult a licensed attorney in your jurisdiction for advice on your specific situation.