Importer of Controlled Substances Application: Leading Pharma LLC, 102954 [2024-29997]
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102954
Federal Register / Vol. 89, No. 243 / Wednesday, December 18, 2024 / Notices
molding machines and products
containing the same’’;
(3) For the purpose of the
investigation so instituted, the following
are hereby named as parties upon which
this notice of investigation shall be
served:
(a) The complainants are:
Issued: December 12, 2024.
Lisa Barton,
Secretary to the Commission.
Husky Injection Molding Systems LTD.,
500 Queen Street South, Bolton,
Ontario, Canada L7E 5S5
Husky Injection Molding Systems, Inc.,
288 North Road, Milton, VT, USA,
05468
Drug Enforcement Administration
khammond on DSK9W7S144PROD with NOTICES
18:09 Dec 17, 2024
Jkt 265001
DEPARTMENT OF JUSTICE
Controlled
substance
Drug code
[Docket No. DEA–1444]
Diphenoxylate ...
9170
Importer of Controlled Substances
Application: Leading Pharma LLC
The company plans to import the
listed controlled substance as an
importer active pharmaceutical
ingredient for research and development
toward manufacturing a finished dosage
product for Food and Drug
Administration approval. 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.
Leading Pharma LLC to be
registered as an importer of basic
class(es) of controlled substance(s).
Refer to Supplementary Information
listed below for further drug
information.
SUMMARY:
(4) For the investigation so instituted,
the Chief Administrative Law Judge,
U.S. International Trade Commission,
shall designate the presiding
Administrative Law Judge.
Responses to the complaint and the
notice of investigation must be
submitted by the named respondent in
accordance with section 210.13 of the
Commission’s Rules of Practice and
Procedure, 19 CFR 210.13. Pursuant to
19 CFR 201.16(e) and 210.13(a), as
amended in 85 FR 15798 (March 19,
2020), such responses will be
considered by the Commission if
received not later than 20 days after the
date of service by the complainants of
the complaint and the notice of
investigation. Extensions of time for
submitting responses to the complaint
and the notice of investigation will not
be granted unless good cause therefor is
shown.
Failure of the respondent to file a
timely response to each allegation in the
complaint and in this notice may be
deemed to constitute a waiver of the
right to appear and contest the
allegations of the complaint and this
notice, and to authorize the
administrative law judge and the
Commission, without further notice to
the respondent, to find the facts to be as
alleged in the complaint and this notice
and to enter an initial determination
and a final determination containing
such findings, and may result in the
issuance of an exclusion order or a cease
and desist order or both directed against
the respondent.
VerDate Sep<11>2014
BILLING CODE 7020–02–P
Drug Enforcement
Administration, Justice.
ACTION: Notice of application.
NINGBO AO SHENG MOLD CO., LTD.,
d/b/a AOSIMI, No. 8 Xingde Rd.
Ditang Ave. YuYao, Zhejiang 315480,
China
By order of the Commission.
[FR Doc. 2024–29906 Filed 12–17–24; 8:45 am]
AGENCY:
(b) The respondent is the following
entity alleged to be in violation of
section 337, and is the party upon
which the complaint is to be served:
In
accordance with 21 CFR 1301.34(a), this
is notice that on September 27, 2024,
Leading Pharma LLC, 3 Oak Road,
Fairfield, New Jersey 07004, applied to
be registered as an importer of the
following basic class(es) of controlled
substance(s):
SUPPLEMENTARY 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 January 17, 2025. Such
persons may also file a written request
for a hearing on the application on or
before January 17, 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.
DATES:
PO 00000
Frm 00103
Fmt 4703
Sfmt 4703
Schedule
II
Matthew Strait,
Deputy Assistant Administrator.
[FR Doc. 2024–29997 Filed 12–17–24; 8:45 am]
BILLING CODE
DEPARTMENT OF JUSTICE
[OMB Number 1117–0053]
Agency Information Collection
Activities; Proposed eCollection
eComments Requested; Leadership
Engagement Survey (LES)
Drug Enforcement
Administration, Department of Justice.
ACTION: 30-Day notice.
AGENCY:
The Drug Enforcement
Administration, Department of Justice
(DOJ), will be submitting the following
information collection request to the
Office of Management and Budget
(OMB) for review and approval in
accordance with the Paperwork
Reduction Act of 1995.
DATES: Comments are encouraged and
will be accepted for 30 days until
January 10, 2025.
FOR FURTHER INFORMATION CONTACT: If
you have comments especially on the
estimated public burden or associated
response time, suggestions, or need a
copy of the proposed information
collection instrument with instructions
or additional information, please
SUMMARY:
E:\FR\FM\18DEN1.SGM
18DEN1
]]>Agencies
[Federal Register Volume 89, Number 243 (Wednesday, December 18, 2024)]
[Notices]
[Page 102954]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-29997]
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA-1444]
Importer of Controlled Substances Application: Leading Pharma LLC
AGENCY: Drug Enforcement Administration, Justice.
ACTION: Notice of application.
-----------------------------------------------------------------------
SUMMARY: Leading Pharma LLC 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
January 17, 2025. Such persons may also file a written request for a
hearing on the application on or before January 17, 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 September 27, 2024, Leading Pharma LLC, 3 Oak Road,
Fairfield, New Jersey 07004, applied to be registered as an importer of
the following basic class(es) of controlled substance(s):
------------------------------------------------------------------------
Controlled substance Drug code Schedule
------------------------------------------------------------------------
Diphenoxylate...................... 9170 II
------------------------------------------------------------------------
The company plans to import the listed controlled substance as an
importer active pharmaceutical ingredient for research and development
toward manufacturing a finished dosage product for Food and Drug
Administration approval. 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. 2024-29997 Filed 12-17-24; 8:45 am]
BILLING CODE
