[Federal Register Volume 87, Number 49 (Monday, March 14, 2022)]
[Notices]
[Page 14290]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-05323]


-----------------------------------------------------------------------

DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. DEA-978]


Bulk Manufacturer of Controlled Substances: ANI Pharmaceuticals, 
Inc.

AGENCY: Drug Enforcement Administration, Justice.

ACTION: Notice of application.

-----------------------------------------------------------------------

SUMMARY: ANI Pharmaceuticals, Inc., has applied to be registered as a 
bulk manufacturer 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 
May 13, 2022. Such persons may also file a written request for a 
hearing on the application on or before May 13, 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.''

SUPPLEMENTARY INFORMATION: In accordance with 21 CFR 1301.33(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 a 
bulk manufacturer of the following basic class(es) of controlled 
substance(s):

------------------------------------------------------------------------
                                          Drug
          Controlled substance            code           Schedule
------------------------------------------------------------------------
Psilocybin.............................    7437  I
Psilocyn...............................    7438  I
Levorphanol............................    9220  II
------------------------------------------------------------------------

    The company plans to bulk manufacture the listed controlled 
substances for the internal use or for sale to its customers. No other 
activities for these drug codes are authorized for this registration.

Matthew J. Strait,
Deputy Assistant Administrator.
[FR Doc. 2022-05323 Filed 3-11-22; 8:45 am]
BILLING CODE P