[Federal Register Volume 87, Number 45 (Tuesday, March 8, 2022)]
[Notices]
[Page 12982]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-04803]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. DEA-961]


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 
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 
April 7, 2022. Such persons may also file a written request for a 
hearing on the application on or before April 7, 2022.

ADDRESSES: The DEA 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 January 6, 2022, 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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Psilocybin.............................     7437  I
Levorphanol............................     9220  II
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    The substance Levorphanol (9220) will be used to manufacture the 
Food and Drug Administration-approved dosage forms for distribution in 
the United States. The substance Psilocybin (7437) will be used to 
support formulation development and clinical trial research. 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.

Matthew J. Strait,
Deputy Assistant Administrator.
[FR Doc. 2022-04803 Filed 3-7-22; 8:45 am]
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