Importer of Controlled Substance Application: Fisher Clinical Services, Inc., 12367-12368 [2025-04285]
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ddrumheller on DSK120RN23PROD with NOTICES1
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.
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18:51 Mar 14, 2025
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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:
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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
12368
Federal Register / Vol. 90, No. 50 / Monday, March 17, 2025 / Notices
Comment Tracking Number, your
comment has been successfully
submitted and there is no need to
resubmit the same comment. All request
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
request 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 September 13, 2024,
Fisher Clinical Services, Inc. 7554
Schantz Road, Allentown, Pennsylvania
18106–9032, applied to be registered as
an importer of the following basic
class(es) of controlled substance(s):
Controlled substance
Marihuana Extract ...........
Marihuana ........................
Dimethyltryptamine ..........
Psilocybin ........................
Methylphenidate ..............
Levorphanol .....................
Noroxymorphone .............
Tapentadol ......................
Drug
code
Schedule
7350
7360
7435
7437
1724
9220
9668
9780
I
I
I
I
II
II
II
II
The company plans to import the
listed controlled substances for clinical
trials only. 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.
[FR Doc. 2025–04285 Filed 3–14–25; 8:45 am]
BILLING CODE P
ddrumheller on DSK120RN23PROD with NOTICES1
DEPARTMENT OF LABOR
Agency Information Collection
Activities; Submission for OMB
Review; Comment Request; COVID–19
Recordkeeping and Reporting in
Healthcare Standard
Notice of availability; request
for comments.
ACTION:
The Department of Labor
(DOL) is submitting this Occupational
SUMMARY:
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18:51 Mar 14, 2025
Jkt 265001
Safety & Health Administration (OSHA)sponsored information collection
request (ICR) to the Office of
Management and Budget (OMB) for
review and approval in accordance with
the Paperwork Reduction Act of 1995
(PRA). Public comments on the ICR are
invited.
DATES: The OMB will consider all
written comments that the agency
receives on or before April 16, 2025.
ADDRESSES: Written comments and
recommendations for the proposed
information collection should be sent
within 30 days of publication of this
notice to www.reginfo.gov/public/do/
PRAMain. Find this particular
information collection by selecting
‘‘Currently under 30-day Review—Open
for Public Comments’’ or by using the
search function.
FOR FURTHER INFORMATION CONTACT:
Nicole Bouchet by telephone at 202–
693–0213, or by email at DOL_PRA_
PUBLIC@dol.gov.
SUPPLEMENTARY INFORMATION: This
collection of information contains
collection of information requirements
originally intended to assist both
employers and employees in addressing
the risk of occupational exposure to
COVID–19. Specifically, OSHA found in
2021 that these requirements were
necessary to address the grave danger to
healthcare employees from transmission
of the SARS–CoV–2 virus in the
workplace, resulting in COVID–19. For
additional substantive information
about this ICR, see the related notice
published in the Federal Register on
October 9, 2024 (89 FR 81949).
Comments are invited on: (1) whether
the collection of information is
necessary for the proper performance of
the functions of the Department,
including whether the information will
have practical utility; (2) the accuracy of
the agency’s estimates of the burden and
cost of the collection of information,
including the validity of the
methodology and assumptions used; (3)
ways to enhance the quality, utility and
clarity of the information collection; and
(4) ways to minimize the burden of the
collection of information on those who
are to respond, including the use of
automated collection techniques or
other forms of information technology.
This information collection is subject
to the PRA. A Federal agency generally
cannot conduct or sponsor a collection
of information, and the public is
generally not required to respond to an
information collection, unless the OMB
approves it and displays a currently
valid OMB Control Number. In addition,
notwithstanding any other provisions of
law, no person shall generally be subject
PO 00000
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Sfmt 4703
to penalty for failing to comply with a
collection of information that does not
display a valid OMB Control Number.
See 5 CFR 1320.5(a) and 1320.6.
On February 5, 2025, OSHA
announced that until further notice it
was not enforcing the requirement to
establish, maintain, and provide copies
of a COVID–19 log under 29 CFR
1910.502(q)(2)(ii) and (q)(3)(ii)–(iv) or to
report COVID–19 fatalities and
hospitalizations under 29 CFR
1910.502(r). OSHA intends to initiate a
rulemaking to remove all of Subpart U,
including those requirements, from 29
CFR 1910. If OSHA removes subpart U
the associated information collection
request would become moot.
A rulemaking to remove subpart U
will take time. To ensure full
compliance with the technical
requirements of the PRA during this
interim period, DOL seeks PRA
authorization for this information
collection for three (3) years. DOL notes
that this extension request does not
indicate any intent by the agency to
enforce any portion of subpart U. OMB
authorization for an ICR cannot be for
more than three (3) years without
renewal. The DOL notes that
information collection requirements
submitted to the OMB for existing ICRs
receive a month-to-month extension
while they undergo review.
Agency: DOL–OSHA.
Title of Collection: COVID–19
Recordkeeping and Reporting in
Healthcare Standard.
OMB Control Number: 1218–0277.
Affected Public: Private Sector—
Businesses or other for-profits.
Total Estimated Number of
Respondents: 78,571.
Total Estimated Number of
Responses: 207,860.
Total Estimated Annual Time Burden:
23,714 hours.
Total Estimated Annual Other Costs
Burden: $0.
(Authority: 44 U.S.C. 3507(a)(1)(D))
Nicole Bouchet,
Senior Paperwork Reduction Act Analyst.
[FR Doc. 2025–04261 Filed 3–14–25; 8:45 am]
BILLING CODE 4510–26–P
LEGAL SERVICES CORPORATION
Sunshine Act Meetings
The Governance and
Performance Review and Operations
and Regulations Committees of the
Legal Services Corporation Board of
Directors will meet virtually on March
24 and March 31, 2025, respectively. On
March 24, the Governance and
TIME AND DATE:
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]]>Agencies
[Federal Register Volume 90, Number 50 (Monday, March 17, 2025)]
[Notices]
[Pages 12367-12368]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2025-04285]
-----------------------------------------------------------------------
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA-1489]
Importer of Controlled Substance Application: Fisher Clinical
Services, Inc.
AGENCY: Drug Enforcement Administration, Justice.
ACTION: Notice of application.
-----------------------------------------------------------------------
SUMMARY: 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
[[Page 12368]]
Comment Tracking Number, your comment has been successfully submitted
and there is no need to resubmit the same comment. All request 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 request 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 September 13, 2024, Fisher Clinical Services, Inc.
7554 Schantz Road, Allentown, Pennsylvania 18106-9032, applied to be
registered as an importer of the following basic class(es) of
controlled substance(s):
------------------------------------------------------------------------
Drug
Controlled substance code Schedule
------------------------------------------------------------------------
Marihuana Extract....................... 7350 I
Marihuana............................... 7360 I
Dimethyltryptamine...................... 7435 I
Psilocybin.............................. 7437 I
Methylphenidate......................... 1724 II
Levorphanol............................. 9220 II
Noroxymorphone.......................... 9668 II
Tapentadol.............................. 9780 II
------------------------------------------------------------------------
The company plans to import the listed controlled substances for
clinical trials only. 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. 2025-04285 Filed 3-14-25; 8:45 am]
BILLING CODE P
