Importer of Controlled Substances Application: Meridian Medical Technologies, 76107-76108 [2020-26172]
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Federal Register / Vol. 85, No. 229 / Friday, November 27, 2020 / Notices
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By order of the Commission.
Issued: November 20, 2020.
Lisa Barton,
Secretary to the Commission.
DEPARTMENT OF JUSTICE
DEPARTMENT OF JUSTICE
Antitrust Division
Drug Enforcement Administration
Notice Pursuant to the National
Cooperative Research and Production
Act of 1993—Open Source Imaging
Consortium, Inc.
Notice is hereby given that, on
November 13, 2020, pursuant to Section
6(a) of the National Cooperative
Research and Production Act of 1993,
15 U.S.C. 4301 et seq. (‘‘the Act’’), Open
Source Imaging Consortium, Inc.
(‘‘Open Source Imaging Consortium’’)
has filed written notifications
simultaneously with the Attorney
General and the Federal Trade
Commission disclosing changes in its
membership. The notifications were
filed for the purpose of extending the
Act’s provisions limiting the recovery of
antitrust plaintiffs to actual damages
under specified circumstances.
Specifically, Vida Diagnostics, Inc.,
Coralville, IA; and University of Genoa,
Genoa, ITALY, have been added as
parties to this venture.
No other changes have been made in
either the membership or planned
activity of the group research project.
Membership in this group research
project remains open, and Open Source
Imaging Consortium intends to file
additional written notifications
disclosing all changes in membership.
On March 20, 2019, Open Source
Imaging Consortium filed its original
notification pursuant to Section 6(a) of
the Act. The Department of Justice
published a notice in the Federal
Register pursuant to Section 6(b) of the
Act on April 12, 2019 (84 FR 14973).
The last notification was filed with
the Department on August 19, 2020. A
notice was published in the Federal
Register pursuant to Section 6(b) of the
Act on August 28, 2020 (85 FR 53402).
Suzanne Morris,
Chief, Premerger and Division Statistics,
Antitrust Division.
[FR Doc. 2020–26188 Filed 11–25–20; 8:45 am]
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76107
[Docket No. DEA–744]
Importer of Controlled Substances
Application: Meridian Medical
Technologies
Drug Enforcement
Administration, Justice.
AGENCY:
ACTION:
Notice of application.
Meridian Medical
Technologies has applied to be
registered as an importer of basic
class(es) of controlled substance(s).
Refer to Supplemental 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 December 28, 2020. Such
persons may also file a written request
for a hearing on the application on or
before December 28, 2020.
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:
In
accordance with 21 CFR 1301.34(a), this
is notice that on November 3, 2020,
Meridian Medical Technologies, 2555
Hermelin Drive, Saint Louis, Missouri
63144, applied to be registered as an
importer of the following basic class(es)
of controlled substance(s):
SUPPLEMENTARY INFORMATION:
Controlled substance
Drug code
Schedule
Morphine ..................................................................................................................................................................
9300
II
The company manufactures a product
containing morphine in the United
VerDate Sep<11>2014
19:29 Nov 25, 2020
Jkt 253001
States. The company exports this
product to customers around the world.
PO 00000
Frm 00104
Fmt 4703
Sfmt 4703
The company has been asked to ensure
that its product, which is sold to
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76108
Federal Register / Vol. 85, No. 229 / Friday, November 27, 2020 / Notices
European customers, meets the
standards established by the European
Pharmacopeia, administered by the
Directorate for the quality of Medicines
(EDQM). In order to ensure that its
product will meet European
specifications, the company seeks to
import morphine supplied by EDQM for
use as 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.
Levorphanol .....................
Drug
code
Schedule
9220
II
The company plans to bulk
manufacture the above-controlled
substance to support production of the
company’s Food and Drug
Administration approved drug product.
No other activity for this drug code is
authorized for this registration.
William T. McDermott,
Assistant Administrator.
[FR Doc. 2020–26171 Filed 11–25–20; 8:45 am]
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
William T. McDermott,
Assistant Administrator.
[Docket No. DEA–746]
[FR Doc. 2020–26172 Filed 11–25–20; 8:45 am]
Importer of Controlled Substances
Application: Noramco Inc.
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Drug Enforcement Administration
Drug Enforcement
Administration, Justice.
ACTION: Notice of application.
[Docket No. DEA–743]
SUMMARY:
AGENCY:
DEPARTMENT OF JUSTICE
Bulk Manufacturer of Controlled
Substances Application: Novitium
Pharma LLC
Drug Enforcement
Administration, Justice.
ACTION: Notice of application.
AGENCY:
Novitium Pharma LLC has
applied to be registered as a bulk
manufacturer of basic class(es) of
controlled substance(s). Refer to
Supplemental 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 January 26, 2021. Such
persons may also file a written request
for a hearing on the application on or
before January 26, 2021.
ADDRESSES: Written comments should
be sent to: Drug Enforcement
Administration, Attention: DEA Federal
Register Representative/DPW, 8701
Morrissette Drive, Springfield, Virginia
22152.
SUPPLEMENTARY INFORMATION: In
accordance with 21 CFR 1301.33(a), this
is notice that on November 2, 2020,
Novitium Pharma LLC, 70 Lake Drive,
East Windsor, New Jersey 08520,
applied to be registered as a bulk
manufacturer of the following basic
class(es) of controlled substances:
SUMMARY:
jbell on DSKJLSW7X2PROD with NOTICES
Controlled substance
VerDate Sep<11>2014
19:29 Nov 25, 2020
Jkt 253001
Noramco Inc. has applied to
be registered as an importer of basic
class(es) of controlled substance(s).
Refer to Supplemental 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 December 28, 2020. Such
persons may also file a written request
for a hearing on the application on or
before December 28, 2020.
ADDRESSES: 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.
SUPPLEMENTARY INFORMATION: In
accordance with 21 CFR 1301.34(a), this
is notice that on October 23, 2020,
Noramco Inc., 500 Swedes Landing
Road, Wilmington, Delaware, 19801–
PO 00000
Frm 00105
Fmt 4703
Sfmt 4703
4417, applied to be registered as an
importer of the following basic class(es)
of controlled substance(s):
Controlled substance
Marihuana ........................
Tetrahydrocannabinols ....
Nabilone ..........................
Phenylacetone .................
Opium, Raw .....................
Poppy Straw Concentrate
Tapentadol ......................
Drug
code
Schedule
7360
7370
7379
8501
9600
9670
9780
I
I
II
II
II
II
II
The company plans to import
Phenylacetone (8501), and Poppy Straw
Concentrate (9670) to bulk manufacture
other controlled substances for
distribution to its customers. The
company plans to import an
intermediate form of Tapentadol (9780)
to bulk manufacture Tapentadol for
distribution to its customers. In
reference to drug codes 7360
(Marihuana) and 7370
(Tetrahydrocannabinols), the company
plans to import a synthetic cannabidiol
and a synthetic Tetrahydrocannabinol.
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.
William T. McDermott,
Assistant Administrator.
[FR Doc. 2020–26174 Filed 11–25–20; 8:45 am]
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA–742]
Importer of Controlled Substances
Application: Lyndra Therapeutics
Drug Enforcement
Administration, Justice.
ACTION: Notice of application.
AGENCY:
Lyndra Therapeutics has
applied to be registered as an importer
of basic class(es) of controlled
substance(s). Refer to Supplemental
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
SUMMARY:
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]]>Agencies
[Federal Register Volume 85, Number 229 (Friday, November 27, 2020)]
[Notices]
[Pages 76107-76108]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-26172]
-----------------------------------------------------------------------
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA-744]
Importer of Controlled Substances Application: Meridian Medical
Technologies
AGENCY: Drug Enforcement Administration, Justice.
ACTION: Notice of application.
-----------------------------------------------------------------------
SUMMARY: Meridian Medical Technologies has applied to be registered as
an importer of basic class(es) of controlled substance(s). Refer to
Supplemental 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 December 28,
2020. Such persons may also file a written request for a hearing on the
application on or before December 28, 2020.
ADDRESSES: 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.
SUPPLEMENTARY INFORMATION: In accordance with 21 CFR 1301.34(a), this
is notice that on November 3, 2020, Meridian Medical Technologies, 2555
Hermelin Drive, Saint Louis, Missouri 63144, applied to be registered
as an importer of the following basic class(es) of controlled
substance(s):
------------------------------------------------------------------------
Controlled substance Drug code Schedule
------------------------------------------------------------------------
Morphine.............................. 9300 II
------------------------------------------------------------------------
The company manufactures a product containing morphine in the
United States. The company exports this product to customers around the
world. The company has been asked to ensure that its product, which is
sold to
[[Page 76108]]
European customers, meets the standards established by the European
Pharmacopeia, administered by the Directorate for the quality of
Medicines (EDQM). In order to ensure that its product will meet
European specifications, the company seeks to import morphine supplied
by EDQM for use as 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 non-approved finished
dosage forms for commercial sale.
William T. McDermott,
Assistant Administrator.
[FR Doc. 2020-26172 Filed 11-25-20; 8:45 am]
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