Importer of Controlled Substances Application: ANI Pharmaceuticals, Inc., 19989 [2023-06949]
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19989
Federal Register / Vol. 88, No. 64 / Tuesday, April 4, 2023 / Notices
applications to import controlled
substances. 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
and Drug Administration-approved or
non-approved finished dosage forms for
commercial sale.
Matthew J. Strait,
Deputy Assistant Administrator.
[FR Doc. 2023–06953 Filed 4–3–23; 8:45 am]
BILLING CODE P
DEPARTMENT OF JUSTICE
Controlled
substance
Drug Enforcement Administration
Importer of Controlled Substances
Application: ANI Pharmaceuticals, Inc.
Drug Enforcement
Administration, Justice.
ACTION: Notice of application.
AGENCY:
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 May 4, 2023. Such persons
may also file a written request for a
hearing on the application on or before
May 4, 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
22152; and (2) Drug Enforcement
ddrumheller on DSK120RN23PROD with NOTICES1
SUMMARY:
19:41 Apr 03, 2023
Drug
code
Psilocybin ...
Levorphanol
[Docket No. DEA–1178]
VerDate Sep<11>2014
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 March 3, 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):
Jkt 259001
Schedule
7437
9220
I
II
Psilocybin (7437) will be imported to
support research, formulation
development, and clinical trials of an
experimental drug product for the
United States market. Levorphanol
(9220) will be imported as bulk active
pharmaceutical ingredient (API) to
support the manufacturing of Food and
Drug Administration-approved dosage
forms for distribution in the United
States. No other activities 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 and Drug
Administration-approved or nonapproved finished dosage forms for
commercial sale.
Matthew Strait,
Deputy Assistant Administrator.
Supplementary Information listed below
for further drug information.
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 June 5, 2023. Such persons
may also file a written request for a
hearing on the application on or before
June 5, 2023.
DATES:
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.
ADDRESSES:
In
accordance with 21 CFR 1301.33(a), this
is notice that on March 14, 2023,
Research Triangle Institute, 3040 East
Cornwallis Road, Hermann Building,
Room 106, Research Triangle Park,
North Carolina 27709, applied to be
registered as a bulk manufacturer of the
following basic class(es) of controlled
substance(s):
SUPPLEMENTARY INFORMATION:
Controlled substance
[FR Doc. 2023–06949 Filed 4–3–23; 8:45 am]
Tetrahydrocannabinols .........
Drug
code
7370
Schedule
I
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA–1175]
Bulk Manufacturer of Controlled
Substances Application: Research
Triangle Institute
The company plans to bulk
manufacture the listed controlled
substance synthetically for distribution
to its customers for research and as
analytical reference standards. No other
activities for these drug codes are
authorized for this registration.
Matthew Strait,
Deputy Assistant Administrator.
[FR Doc. 2023–06951 Filed 4–3–23; 8:45 am]
Drug Enforcement
Administration, Justice.
ACTION: Notice of application.
AGENCY:
BILLING CODE 4410–09–P
Research Triangle Institute
has applied to be registered as a bulk
manufacturer of basic class(es) of
controlled substance(s). Refer to
SUMMARY:
PO 00000
Frm 00087
Fmt 4703
Sfmt 9990
E:\FR\FM\04APN1.SGM
04APN1
Agencies
[Federal Register Volume 88, Number 64 (Tuesday, April 4, 2023)]
[Notices]
[Page 19989]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-06949]
-----------------------------------------------------------------------
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA-1178]
Importer of Controlled Substances Application: ANI
Pharmaceuticals, Inc.
AGENCY: Drug Enforcement Administration, Justice.
ACTION: Notice of application.
-----------------------------------------------------------------------
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
May 4, 2023. Such persons may also file a written request for a hearing
on the application on or before May 4, 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 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 March 3, 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):
------------------------------------------------------------------------
Controlled substance Drug code Schedule
------------------------------------------------------------------------
Psilocybin........................ 7437 I
Levorphanol....................... 9220 II
------------------------------------------------------------------------
Psilocybin (7437) will be imported to support research, formulation
development, and clinical trials of an experimental drug product for
the United States market. Levorphanol (9220) will be imported as bulk
active pharmaceutical ingredient (API) to support the manufacturing of
Food and Drug Administration-approved dosage forms for distribution in
the United States. No other activities 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 and Drug Administration-approved or non-approved finished
dosage forms for commercial sale.
Matthew Strait,
Deputy Assistant Administrator.
[FR Doc. 2023-06949 Filed 4-3-23; 8:45 am]
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