Importer of Controlled Substances Application: Indivior Inc., 71928 [2024-19754]
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71928
Federal Register / Vol. 89, No. 171 / Wednesday, September 4, 2024 / Notices
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.
Controlled substance
Drug code
Ibogaine ......................................................................................
Marihuana Extract ......................................................................
Tetrahydrocannabinols ...............................................................
Mescaline ....................................................................................
3,4-Methylenedioxyamphetamine ...............................................
3,4-Methylenedioxymethamphetamine .......................................
5-Methoxy-N-N-dimethyltryptamine ............................................
Dimethyltryptamine .....................................................................
Psilocybin ....................................................................................
Psilocyn ......................................................................................
5-Methoxy-N,N-diisopropyltryptamine ........................................
The company plans to bulk
manufacture the listed controlled
substances for internal research and
dosage formulation development. No
other activities for these drug codes are
authorized for this registration.
Marsha L. Ikner,
Acting Deputy Assistant Administrator.
[FR Doc. 2024–19795 Filed 9–3–24; 8:45 am]
BILLING CODE P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA–1392]
Importer of Controlled Substances
Application: Indivior Inc.
Drug Enforcement
Administration, Justice.
ACTION: Notice of application.
AGENCY:
Indivior 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 October 4, 2024. Such
persons may also file a written request
for a hearing on the application on or
before October 4, 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
ddrumheller on DSK120RN23PROD with NOTICES1
SUMMARY:
VerDate Sep<11>2014
21:26 Sep 03, 2024
Jkt 262001
In
accordance with 21 CFR 1301.33(a), this
is notice that on June 7, 2024, Benuvia
Operations, LLC, 3950 North Mays
Street, Round Rock, Texas 78665,
applied to be registered as a bulk
manufacturer of the following basic
class(es) of controlled substance(s):
SUPPLEMENTARY INFORMATION:
Schedule
7260
7350
7370
7381
7400
7405
7431
7435
7437
7438
7439
I
I
I
I
I
I
I
I
I
I
I
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 June 17, 2024, Indivior
Inc., 2607 Midpoint Drive, Fort Collins,
Colorado 80525–4427, applied to be
registered as an importer of the
following basic class(es) of controlled
substance(s):
Controlled
substance
Drug code
Thebaine .........
9333
Schedule
II
The company plans to import the
listed controlled substance in limited
quantity for research, clinical trials,
PO 00000
Frm 00051
Fmt 4703
Sfmt 4703
analytical purposes, and for the
manufacturing process development of
the dosage form. 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 Food and Drug
Administration-approved or nonapproved finished dosage forms for
commercial sale.
Marsha L. Ikner,
Acting Deputy Assistant Administrator.
[FR Doc. 2024–19754 Filed 9–3–24; 8:45 am]
BILLING CODE 4410–09–P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA–1409]
Importer of Controlled Substances
Application: Amneal Complex
Products Research LLC
Drug Enforcement
Administration, Justice.
ACTION: Notice of application.
AGENCY:
Amneal Complex Products
Research 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
SUMMARY:
E:\FR\FM\04SEN1.SGM
04SEN1
]]>Agencies
[Federal Register Volume 89, Number 171 (Wednesday, September 4, 2024)]
[Notices]
[Page 71928]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-19754]
-----------------------------------------------------------------------
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA-1392]
Importer of Controlled Substances Application: Indivior Inc.
AGENCY: Drug Enforcement Administration, Justice.
ACTION: Notice of application.
-----------------------------------------------------------------------
SUMMARY: Indivior 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
October 4, 2024. Such persons may also file a written request for a
hearing on the application on or before October 4, 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 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 June 17, 2024, Indivior Inc., 2607 Midpoint Drive,
Fort Collins, Colorado 80525-4427, applied to be registered as an
importer of the following basic class(es) of controlled substance(s):
------------------------------------------------------------------------
Controlled substance Drug code Schedule
------------------------------------------------------------------------
Thebaine........................... 9333 II
------------------------------------------------------------------------
The company plans to import the listed controlled substance in
limited quantity for research, clinical trials, analytical purposes,
and for the manufacturing process development of the dosage form. 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 Food and Drug Administration-approved or non-approved finished
dosage forms for commercial sale.
Marsha L. Ikner,
Acting Deputy Assistant Administrator.
[FR Doc. 2024-19754 Filed 9-3-24; 8:45 am]
BILLING CODE 4410-09-P
