[Federal Register Volume 88, Number 13 (Friday, January 20, 2023)]
[Notices]
[Page 3763]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-01047]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. DEA-1127]


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 
March 21, 2023. Such persons may also file a written request for a 
hearing on the application on or before March 21, 2023.

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 6, 2022, 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):

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                                           Drug
          Controlled substance             code          Schedule
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Pentobarbital..........................     2270  II
Levomethorphan.........................     9210  II
Levorphanol............................     9220  II
Remifentanil...........................     9739  II
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    The company plans to bulk manufacture Active Pharmaceutical 
Ingredients (API) quantities of the listed controlled substances for 
validation purpose and the Food and Drug Administration approval. No 
other activities for these drug codes are authorized for this 
registration.

Matthew Strait,
Deputy Assistant Administrator.
[FR Doc. 2023-01047 Filed 1-19-23; 8:45 am]
BILLING CODE 4410-09-P