Importer of Controlled Substances Application: Indivior Inc., 11438 [2025-03635]
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11438
Federal Register / Vol. 90, No. 43 / Thursday, March 6, 2025 / Notices
should be imposed if a remedy is
ordered.
Written Submissions: Parties to the
investigation, interested government
agencies, and any other interested
parties are encouraged to file written
submissions on the issues of remedy,
the public interest, and bonding. In their
initial submission, Complainants are
also requested to identify the remedy
sought and Complainants are requested
to submit proposed remedial orders for
the Commission’s consideration.
Complainants are further requested to
state the dates that the Asserted Patents
expire, to provide the HTSUS
subheadings under which the accused
products are imported, and to supply
the identification information for all
known importers of the products at
issue in this investigation. The initial
written submissions and proposed
remedial orders must be filed no later
than close of business on March 14,
2025. Reply submissions must be filed
no later than the close of business on
March 21, 2025. No further submissions
on any of these issues will be permitted
unless otherwise ordered by the
Commission.
Persons filing written submissions
must file the original document
electronically on or before the deadlines
stated above pursuant to 19 CFR
210.4(f). Submissions should refer to the
investigation number (‘‘Inv. No. 337–
TA–1427’’) in a prominent place on the
cover page and/or the first page. (See
Handbook for Electronic Filing
Procedures, https://www.usitc.gov/
documents/handbook_on_filing_
procedures.pdf). Persons with questions
regarding filing should contact the
Secretary, (202) 205–2000.
Any person desiring to submit a
document to the Commission in
confidence must request confidential
treatment by marking each document
with a header indicating that the
document contains confidential
information. This marking will be
deemed to satisfy the request procedure
set forth in Rules 201.6(b) and
210.5(e)(2) (19 CFR 201.6(b) &
210.5(e)(2)). Documents for which
confidential treatment by the
Commission is properly sought will be
treated accordingly. Any non-party
wishing to submit comments containing
confidential information must serve
those comments on the parties to the
investigation pursuant to the applicable
Administrative Protective Order. A
redacted non-confidential version of the
document must also be filed with the
Commission and served on any parties
to the investigation within two business
days of any confidential filing. All
information, including confidential
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16:42 Mar 05, 2025
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business information and documents for
which confidential treatment is properly
sought, submitted to the Commission for
purposes of this investigation may be
disclosed to and used: (i) by the
Commission, its employees and Offices,
and contract personnel (a) for
developing or maintaining the records
of this or a related proceeding, or (b) in
internal investigations, audits, reviews,
and evaluations relating to the
programs, personnel, and operations of
the Commission including under 5
U.S.C. appendix 3; or (ii) by U.S.
Government employees and contract
personnel, solely for cybersecurity
purposes. All contract personnel will
sign appropriate nondisclosure
agreements. All nonconfidential written
submissions will be available for public
inspection on EDIS.
The Commission’s vote for this
determination took place on February
28, 2025.
The authority for the Commission’s
determination is contained in section
337 of the Tariff Act of 1930, as
amended (19 U.S.C. 1337), and in part
210 of the Commission’s Rules of
Practice and Procedure (19 CFR part
210).
By order of the Commission.
Issued: February 28, 2025.
Lisa Barton,
Secretary to the Commission.
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.
In
accordance with 21 CFR 1301.34(a), this
is notice that on October 18, 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):
SUPPLEMENTARY INFORMATION:
[FR Doc. 2025–03591 Filed 3–5–25; 8:45 am]
BILLING CODE 7020–02–P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
Controlled substance
Drug
code
Schedule
[Docket No. DEA–1450]
Thebaine ....................
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 April 7, 2025. Such persons
may also file a written request for a
hearing on the application on or before
April 7, 2025.
ADDRESSES: The Drug Enforcement
Administration requires that all
SUMMARY:
PO 00000
Frm 00042
Fmt 4703
Sfmt 9990
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 nonapproved finished dosage forms for
commercial sale.
Matthew Strait,
Deputy Assistant Administrator.
[FR Doc. 2025–03635 Filed 3–5–25; 8:45 am]
BILLING CODE P
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]]>Agencies
[Federal Register Volume 90, Number 43 (Thursday, March 6, 2025)]
[Notices]
[Page 11438]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2025-03635]
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA-1450]
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
April 7, 2025. Such persons may also file a written request for a
hearing on the application on or before April 7, 2025.
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 October 18, 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.
Matthew Strait,
Deputy Assistant Administrator.
[FR Doc. 2025-03635 Filed 3-5-25; 8:45 am]
BILLING CODE P
