Importer of Controlled Substances Application: Janssen Pharmaceuticals Inc., 78363 [2020-26653]
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Federal Register / Vol. 85, No. 234 / Friday, December 4, 2020 / Notices
agreements, written or oral, express or
implied between the parties concerning
the subject matter of the investigation.’’
19 CFR 210.21(b)(1).
Consistent with Commission Rule
210.21(b)(1), redacted versions of a
patent license agreement and a
settlement agreement between Rovi and
Comcast were attached to the motion as
Exhibits 1 and 2 and the unredacted
agreements were filed separately under
a confidential header. The moving
parties submit that the agreements
resolve the allegations of infringement
against Comcast in the investigation.
Motion at 1. In further compliance with
Commission Rule 210.21(b)(1), the
motion contains a statement that there
are no other agreements, written or oral,
express or implied between the parties
concerning the subject matter of the
investigation. Id. at 2. The movants
submit that termination is in the interest
of the public and administrative
economy. Id. at 3.
Pursuant to Commission Rule
210.50(b)(2), the Commission finds no
evidence that terminating this
investigation will adversely affect the
public health and welfare, competitive
conditions in the U.S. economy, the
production of like or directly
competitive articles in the United
States, or U.S. customers. 19 CFR
210.50(b)(2). Moreover, the public
interest generally favors settlement to
avoid needless litigation and to
conserve public resources. See, e.g.,
Certain Semiconductor Devices,
Products Containing the Same, and
Components Thereof (II), Inv. No. 337–
TA–1177, Order No. 5 at 2 (Nov. 25,
2019), unreviewed by Comm’n Notice
(Dec. 20, 2019).
Accordingly, the Commission finds
that the joint motion for termination
satisfies Commission Rules 210.21(a)(2)
and (b)(1) (19 CFR 210.21(a)(2), (b)(1))
and that termination of the investigation
is not contrary to the public interest.
Accordingly, the Commission grants
the joint motion to terminate the
investigation in its entirety based on
settlement. The investigation is
terminated.
The Commission vote for this
determination took place on November
30, 2020.
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: November 30, 2020.
Katherine Hiner,
Supervisory Attorney.
[FR Doc. 2020–26685 Filed 12–3–20; 8:45 am]
BILLING CODE 7020–02–P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA–751]
Importer of Controlled Substances
Application: Janssen Pharmaceuticals
Inc.
Drug Enforcement
Administration, Justice.
AGENCY:
ACTION:
Notice of application.
Janssen Pharmaceuticals 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 January 4, 2021. Such persons
may also file a written request for a
hearing on the application on or before
January 4, 2021.
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 11, 2020,
Janssen Pharmaceuticals Inc., 1440
Olympic Drive, Athens, Georgia 30601–
1645, applied to be registered as an
importer of the following basic class(es)
of controlled substance(s):
SUMMARY:
Controlled substance
Drug code
Thebaine ..................................................................................................................................................................
Poppy Straw Concentrate ........................................................................................................................................
Tapentadol ...............................................................................................................................................................
The company plans to import
intermediate forms of Tapentadol (9780)
and Thebaine (9333) for further
manufacturing prior to distribution to
its customers. The company plans to
import Poppy Straw Concentrate (9670)
to bulk manufacture other controlled
substances. 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-
VerDate Sep<11>2014
18:18 Dec 03, 2020
Jkt 253001
approved finished dosage forms for
commercial sale.
William T. McDermott,
Assistant Administrator.
[FR Doc. 2020–26653 Filed 12–3–20; 8:45 am]
BILLING CODE 4410–09–P
DEPARTMENT OF JUSTICE
Notice of Lodging of Proposed
Consent Decree Under the
Comprehensive Environmental
Response, Compensation and Liability
Act
PO 00000
Frm 00062
Fmt 4703
Sfmt 4703
9333
9670
9780
Schedule
II
II
II
On November 27, 2020, the
Department of Justice lodged a proposed
Consent Decree with the United States
District Court for the District of New
Jersey in the lawsuit entitled United
States et al. v. Unimatic Manufacturing,
Corp. et al., Civil Action No. 2:20-cv17284.
The proposed Consent Decree would
resolve claims the United States, New
Jersey Department of Environmental
Protection (‘‘NJDEP’’) and the
Administrator of the New Jersey Spill
Compensation Fund have brought
pursuant to Section 107 of the
Comprehensive Environmental
Response, Compensation, and Liability
E:\FR\FM\04DEN1.SGM
04DEN1
]]>Agencies
[Federal Register Volume 85, Number 234 (Friday, December 4, 2020)]
[Notices]
[Page 78363]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-26653]
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA-751]
Importer of Controlled Substances Application: Janssen
Pharmaceuticals Inc.
AGENCY: Drug Enforcement Administration, Justice.
ACTION: Notice of application.
-----------------------------------------------------------------------
SUMMARY: Janssen Pharmaceuticals 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 January 4, 2021.
Such persons may also file a written request for a hearing on the
application on or before January 4, 2021.
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 11, 2020, Janssen Pharmaceuticals Inc., 1440
Olympic Drive, Athens, Georgia 30601-1645, applied to be registered as
an importer of the following basic class(es) of controlled
substance(s):
------------------------------------------------------------------------
Controlled substance Drug code Schedule
------------------------------------------------------------------------
Thebaine................................ 9333 II
Poppy Straw Concentrate................. 9670 II
Tapentadol.............................. 9780 II
------------------------------------------------------------------------
The company plans to import intermediate forms of Tapentadol (9780)
and Thebaine (9333) for further manufacturing prior to distribution to
its customers. The company plans to import Poppy Straw Concentrate
(9670) to bulk manufacture other controlled substances. 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. 2020-26653 Filed 12-3-20; 8:45 am]
BILLING CODE 4410-09-P
