Bulk Manufacturer of Controlled Substances Application: Sterling Pharma USA, LLC, 11731-11732 [2022-04324]
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Federal Register / Vol. 87, No. 41 / Wednesday, March 2, 2022 / Notices
complainant requests that the
Commission institute an investigation
and, after the investigation, issue a
limited exclusion order and cease and
desist orders.
ADDRESSES: The complaint, except for
any confidential information contained
therein, may be viewed on the
Commission’s electronic docket (EDIS)
at https://edis.usitc.gov. For help
accessing EDIS, please email
EDIS3Help@usitc.gov. Hearing impaired
individuals are advised that information
on this matter can be obtained by
contacting the Commission’s TDD
terminal on (202) 205–1810. Persons
with mobility impairments who will
need special assistance in gaining access
to the Commission should contact the
Office of the Secretary at (202) 205–
2000. General information concerning
the Commission may also be obtained
by accessing its internet server at
https://www.usitc.gov.
FOR FURTHER INFORMATION CONTACT:
Jessica Mullan, Office of the Secretary,
Docket Services Division, U.S.
International Trade Commission,
telephone (202) 205–1802.
SUPPLEMENTARY INFORMATION:
Authority: The authority for
institution of this investigation is
contained in section 337 of the Tariff
Act of 1930, as amended, 19 U.S.C.
1337, and in section 210.10 of the
Commission’s Rules of Practice and
Procedure, 19 CFR 210.10 (2021).
Scope of Investigation: Having
considered the complaint, the U.S.
International Trade Commission, on
February 24, 2022, ordered that—
(1) Pursuant to subsection (b) of
section 337 of the Tariff Act of 1930, as
amended, an investigation be instituted
to determine whether there is a
violation of subsection (a)(1)(B) of
section 337 in the importation into the
United States, the sale for importation,
or the sale within the United States after
importation of certain products
identified in paragraph (2) by reason of
infringement of one or more of claims
1–17 of the ’392 patent, and whether an
industry in the United States exists as
required by subsection (a)(2) of section
337;
(2) Pursuant to section 210.10(b)(1) of
the Commission’s Rules of Practice and
Procedure, 19 CFR 210.10(b)(1), the
plain language description of the
accused products or category of accused
products, which defines the scope of the
investigation, is ‘‘products containing
crystalline modification IV of
pyraclostrobin and components
thereof’’;
(3) For the purpose of the
investigation so instituted, the following
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17:34 Mar 01, 2022
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are hereby named as parties upon which
this notice of investigation shall be
served:
(a) The complainants are:
BASF SE, Carl-Bosch-Str. 38, 67056
Ludwigshafen, Germany
BASF Corporation, 100 Campus Drive,
Florham Park, New Jersey 07932
(b) The respondents are the following
entities alleged to be in violation of
section 337, and are the parties upon
which the complaint is to be served:
Sharda Cropchem Ltd., Prime Business
Park, 2nd Floor, Mumbai,
Maharashtra, 400056, India
Sharda USA LLC, 34 E, Germantown
Pike #227, Norristown, PA 19401
(4) For the investigation so instituted,
the Chief Administrative Law Judge,
U.S. International Trade Commission,
shall designate the presiding
Administrative Law Judge.
The Office of Unfair Import
Investigations will not participate as a
party in this investigation.
Responses to the complaint and the
notice of investigation must be
submitted by the named respondents 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 a 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.
By order of the Commission.
Issued: February 24, 2022.
Lisa Barton,
Secretary to the Commission.
[FR Doc. 2022–04338 Filed 3–1–22; 8:45 am]
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA–967]
Bulk Manufacturer of Controlled
Substances Application: Sterling
Pharma USA, LLC
Drug Enforcement
Administration, Justice.
AGENCY:
ACTION:
Notice of application.
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.
SUMMARY:
Registered bulk manufacturers of
the affected basic class(es), and
applicants therefore, may file written
comments on or objections to the
issuance of the proposed registration on
or before May 2, 2022. Such persons
may also file a written request for a
hearing on the application on or before
May 2, 2022.
DATES:
The DEA 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.’’
ADDRESSES:
In
accordance with 21 CFR 1301.33(a), this
is notice that on January 12, 2022,
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):
SUPPLEMENTARY INFORMATION:
Controlled substance
Tetrahydrocannabinols .............
Drug
code
Schedule
7370
I
In reference to drug codes 7370
(Tetrahydrocannabinols), the company
plans to bulk manufacture this drug
exclusively from hemp extract for
distribution and sale to its customer. No
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Federal Register / Vol. 87, No. 41 / Wednesday, March 2, 2022 / Notices
other activities for these drug codes are
authorized for this registration.
Matthew J. Strait,
Deputy Assistant Administrator.
[FR Doc. 2022–04324 Filed 3–1–22; 8:45 am]
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA–968]
Importer of Controlled Substances
Application: Janssen Pharmaceuticals,
Inc.
Drug Enforcement
Administration, Justice.
ACTION: Notice of application.
AGENCY:
Janssen Pharmaceuticals 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 1, 2022. Such persons
may also file a written request for a
hearing on the application on or before
April 1, 2022.
ADDRESSES: The DEA 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
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SUMMARY:
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Administration, Attn: Administrator,
8701 Morrissette Drive, Springfield,
Virginia 22152.
SUPPLEMENTARY INFORMATION: In
accordance with 21 CFR 1301.34(a), this
is notice that on December 10, 2021,
Janssen Pharmaceuticals Inc, 1440
Olympic Drive, Buildings 1–5 and 7–14,
Athens, Georgia 30601–1645, applied to
be registered as an importer of the
following basic class(es) of controlled
substance(s):
Controlled substance
Thebaine ...................................
Poppy Straw Concentrate .........
Tapentadol ................................
Drug
code
Schedule
9333
9670
9780
II
II
II
Registered bulk manufacturers of
the affected basic class(es), and
applicants therefore, may file written
comments on or objections to the
issuance of the proposed registration on
or before April 1, 2022. Such persons
may also file a written request for a
hearing on the application on or before
April 1, 2022.
DATES:
Written comments should
be sent to: Drug Enforcement
Administration, Attention: DEA Federal
Register Representative/DPW, 8701
Morrissette Drive, Springfield, Virginia
22152. All requests for a hearing must
be sent to: Drug Enforcement
Administration, Attn: Administrator,
8701 Morrissette Drive, Springfield,
Virginia 22152. All requests for a
hearing should also 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.
ADDRESSES:
The company plans to import
intermediates classified under
Tapentadol (9780) and Thebaine (9333)
for further manufacturing to the
controlled substances tapentadol and
buprenorpine, respectively, prior to
distribution to customers. The company
plans to import Poppy Straw
Concentrate (9670) to bulk manufacture
other controlled substances. 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.
SUPPLEMENTARY INFORMATION:
Matthew J. Strait,
Deputy Assistant Administrator.
Cocaine .....................................
Ecgonine ...................................
In
accordance with 21 CFR 1301.34(a), this
is notice that on December 16, 2021,
Medi-Physics Inc. dba GE Healthcare,
3350 North Ridge Avenue, Arlington
Heights, Illinois 60004–1412, applied to
be registered as an importer of the
following basic class(es) of controlled
substance(s):
Controlled substance
[FR Doc. 2022–04321 Filed 3–1–22; 8:45 am]
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA–959]
Importer of Controlled Substances
Application: Medi-Physics Inc. dba GE
Healthcare
Drug Enforcement
Administration, Justice.
ACTION: Notice of application.
AGENCY:
Medi-Physics Inc. dba GE
Healthcare 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.
SUMMARY:
PO 00000
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Fmt 4703
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Drug
code
Schedule
9041
II
I 9180 III
The company plans to import
derivatives of the listed controlled
substances to be used for the
manufacture of a diagnostic product and
reference standards. No other activity
for these drug codes 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 J. Strait,
Deputy Assistant Administrator.
[FR Doc. 2022–04371 Filed 3–1–22; 8:45 am]
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]]>Agencies
[Federal Register Volume 87, Number 41 (Wednesday, March 2, 2022)]
[Notices]
[Pages 11731-11732]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-04324]
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA-967]
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 file written comments on or objections to
the issuance of the proposed registration on or before May 2, 2022.
Such persons may also file a written request for a hearing on the
application on or before May 2, 2022.
ADDRESSES: The DEA 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 January 12, 2022, 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
------------------------------------------------------------------------
In reference to drug codes 7370 (Tetrahydrocannabinols), the
company plans to bulk manufacture this drug exclusively from hemp
extract for distribution and sale to its customer. No
[[Page 11732]]
other activities for these drug codes are authorized for this
registration.
Matthew J. Strait,
Deputy Assistant Administrator.
[FR Doc. 2022-04324 Filed 3-1-22; 8:45 am]
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