[Federal Register Volume 88, Number 152 (Wednesday, August 9, 2023)]
[Notices]
[Pages 53926-53927]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-17034]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. DEA-1235]


Importer of Controlled Substances Application: ANI 
Pharmaceuticals Inc.

AGENCY: Drug Enforcement Administration, Justice.

ACTION: Notice of application.

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SUMMARY: ANI Pharmaceuticals Inc. has applied to be registered as an 
importer of basic class(es) of controlled substance(s). Refer to 
Supplemental 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 
September 8, 2023. Such persons may also file a written request for a 
hearing on the application on or before September 8, 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. All 
requests for a hearing must be sent to: (1) Drug Enforcement 
Administration, Attn: Hearing Clerk/OALJ, 8701 Morrissette Drive, 
Springfield, Virginia

[[Page 53927]]

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 June 16, 2023, ANI Pharmaceuticals Inc., 70 Lake 
Drive, East Windsor, New Jersey 08520, 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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Tapentadol.............................     9780  II
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    The substance Tapentadol (9780) will be used in small quantities in 
support of the development of a drug product for Abbreviated New Drug 
submission and eventual marketing. No other activity 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 Drug 
Administration-approved or non-approved finished dosage forms for 
commercial sale.

Claude Redd,
Acting Deputy Assistant Administrator.
[FR Doc. 2023-17034 Filed 8-8-23; 8:45 am]
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