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[Federal Register Volume 89, Number 190 (Tuesday, October 1, 2024)]
[Notices]
[Pages 79950-79951]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-22450]

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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. DEA-1435]

Importer of Controlled Substances Application: Fresenius Kabi 
USA, LLC

AGENCY: Drug Enforcement Administration, Justice.

ACTION: Notice of application.

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SUMMARY: Fresenius Kabi USA, 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.

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 
October 31, 2024. Such persons may also file a written request for a 
hearing on the application on or before October 31, 2024.

ADDRESSES: The Drug Enforcement Administration requires that all 
comments be submitted electronically through the Federal eRulemaking 
Portal, which provides the ability to type short

[[Page 79951]]

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 August 12, 2024, Fresenius Kabi USA, LLC, 3159 Staley 
Road, Grand Island, New York 14072-2028, applied to be registered as an 
importer of the following basic class(es) of controlled substance(s):

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                                          Drug
         Controlled substance             code           Schedule
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Remifentanil..........................     9739   II
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    The company plans to import the listed controlled substance(s) as 
bulk active pharmaceutical ingredient to manufacture Food and Drug 
Administration (FDA)-approved dosage forms. No other activity for this 
drug code is 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 FDA-approved or non-approved finished dosage forms for commercial 
sale.

Marsha L. Ikner,
Acting Deputy Assistant Administrator.
[FR Doc. 2024-22450 Filed 9-30-24; 8:45 am]
BILLING CODE P
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