Bulk Manufacturer of Controlled Substances Application: Sterling Pharma USA LLC, 12367 [2025-04284]
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Federal Register / Vol. 90, No. 50 / Monday, March 17, 2025 / Notices
longer a proper complainant; (2) the
importation requirement has not been
satisfied; (3) Optimum has not shown
that either claims 1 and 12–14 of the
’511 patent or claims 1 and 3 of the ’260
patent are infringed; (4) Optimum has
not satisfied the technical prong of the
domestic industry requirement for the
’511 patent or the ’260 patent; and (5)
Optimum has not satisfied the economic
prong of the domestic industry
requirement for the ’511 patent or the
’260 patent. The FID also grants in part
Xenogenic’s motion to intervene for the
limited purpose of addressing
ownership-related issues in the event of
Commission review of the FID’s
findings of no violation.
The FID includes the ALJ’s
recommended determination (‘‘RD’’) on
remedy, the public interest, and
bonding should the Commission find a
violation of section 337. Specifically,
the RD recommends, if the Commission
finds a violation, issuing a general
exclusion order (‘‘GEO’’) under section
337(d)(2)(A). Id. at 49–52. However, the
RD recommends that the evidence does
not support that there is a widespread
pattern of circumvention and, thus, does
not support issuance of a GEO under
section 337(d)(2)(B). Moreover, because
Optimum failed to show a violation of
section 337 by substantial, reliable, and
probative evidence, the RD does not
recommend issuing a GEO under
section 337(g)(2). The RD does not
recommend issuing any cease and desist
orders. The RD also recommends that,
because Optimum failed to demonstrate
the necessity of a bond, the Commission
should issue a zero percent (0%) bond
for any infringing products imported
during the period of Presidential review.
On December 24, 2024, Optimum
filed a petition for review. On January
7, 2025, Staff filed a response to
Optimum’s petition. Xenogenic did not
file a response to Optimum’s petition.
On January 21, 2025, the Commission
published its post-RD Federal Register
notice seeking submissions on public
interest issues raised by the relief
recommended by the ALJ should the
Commission find a violation. 90 FR
7158–59 (Jan. 21, 2025). On February
10, 2025, Antony Hernandez filed a
submission supporting Optimum’s
request for a GEO. On February 11,
2025, Xenogenic filed a submission
arguing against issuance of a GEO.
Having reviewed the record of this
investigation, the Commission has
determined to review the FID in its
entirety.
The Commission vote for this
determination took place on March 11,
2025.
VerDate Sep<11>2014
18:51 Mar 14, 2025
Jkt 265001
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: March 11, 2025.
Lisa Barton,
Secretary to the Commission.
[FR Doc. 2025–04246 Filed 3–14–25; 8:45 am]
BILLING CODE 7020–02–P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA–1510]
Bulk Manufacturer of Controlled
Substances Application: Sterling
Pharma USA LLC
Sheldon Drive, Suite 101, Cary, North
Carolina 27513–2078 applied to be
registered as a bulk manufacturer of the
following basic class(es) of controlled
substance(s):
Controlled substance
Tetrahydrocannabinols ....
5-Methoxy-N-Ndimethyltryptamine.
Dimethyltryptamine ..........
Psilocybin ........................
Psilocyn ...........................
Drug
code
Schedule
7370
7431
I
I
7435
7437
7438
I
I
I
The company plans to bulk
manufacture the listed controlled
substance(s) to support internal research
and for sale to its customers for preclinical trial studies. No other activities
for these drug codes are authorized for
this registration.
Matthew Strait,
Deputy Assistant Administrator.
Drug Enforcement
Administration, Justice.
ACTION: Notice of application.
[FR Doc. 2025–04284 Filed 3–14–25; 8:45 am]
Sterling Pharma USA LLC has
applied to be registered as a bulk
manufacturer 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 16, 2025. Such persons
may also file a written request for a
hearing on the application on or before
May 16, 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.
SUPPLEMENTARY INFORMATION: In
accordance with 21 CFR 1301.33(a), this
is notice that on February 11, 2025,
Sterling Pharma USA LLC, 1001
DEPARTMENT OF JUSTICE
AGENCY:
SUMMARY:
PO 00000
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BILLING CODE P
Drug Enforcement Administration
[Docket No. DEA–1489]
Importer of Controlled Substance
Application: Fisher Clinical Services,
Inc.
Drug Enforcement
Administration, Justice.
ACTION: Notice of application.
AGENCY:
Fisher Clinical Services, 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 16, 2025. Such
persons may also file a written request
for a hearing on the application on or
before April 16, 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 o the web page or attach a file for
lengthier comments. Please go to
https://www.regulations.gov and follow
the online instructions at that sit for
submitting comments. Upon submission
of your comment, you will receive a
SUMMARY:
E:\FR\FM\17MRN1.SGM
17MRN1
]]>Agencies
[Federal Register Volume 90, Number 50 (Monday, March 17, 2025)]
[Notices]
[Page 12367]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2025-04284]
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA-1510]
Bulk Manufacturer of Controlled Substances Application: Sterling
Pharma USA LLC
AGENCY: Drug Enforcement Administration, Justice.
ACTION: Notice of application.
-----------------------------------------------------------------------
SUMMARY: Sterling Pharma USA LLC has applied to be registered as a bulk
manufacturer 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 16, 2025. Such persons may also file a written request for a
hearing on the application on or before May 16, 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.
SUPPLEMENTARY INFORMATION: In accordance with 21 CFR 1301.33(a), this
is notice that on February 11, 2025, Sterling Pharma USA LLC, 1001
Sheldon Drive, Suite 101, Cary, North Carolina 27513-2078 applied to be
registered as a bulk manufacturer of the following basic class(es) of
controlled substance(s):
------------------------------------------------------------------------
Drug
Controlled substance code Schedule
------------------------------------------------------------------------
Tetrahydrocannabinols................... 7370 I
5-Methoxy-N-N-dimethyltryptamine........ 7431 I
Dimethyltryptamine...................... 7435 I
Psilocybin.............................. 7437 I
Psilocyn................................ 7438 I
------------------------------------------------------------------------
The company plans to bulk manufacture the listed controlled
substance(s) to support internal research and for sale to its customers
for pre-clinical trial studies. No other activities for these drug
codes are authorized for this registration.
Matthew Strait,
Deputy Assistant Administrator.
[FR Doc. 2025-04284 Filed 3-14-25; 8:45 am]
BILLING CODE P
