Importer of Controlled Substances Application: Fisher Clinical Services, Inc., 13519-13520 [2018-06321]
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Federal Register / Vol. 83, No. 61 / Thursday, March 29, 2018 / Notices
patent the Commission determined to
review (1) the ID’s finding that a
combination of prior art references
Doppelt, Jacobs, and Gilbert fail to
render the asserted claims obvious; and
(2) the ID’s finding that a combination
of prior art references Matsuoka,
Doppelt, and Eckel fail to render the
asserted claims obvious. For the ’336
patent the Commission determined to
review (1) the ID’s finding that claim 34
recites ineligible patent subject matter
under 35 U.S.C. 101; and (2) the ID’s
finding that Pruessel, either alone or in
combination with Koestler, fails to
render claim 34 obvious. The
Commission requested the parties to
brief certain issues. Id. On January 5,
2018, the parties filed submissions to
the Commission’s question and on
remedy, the public interest, and
bonding. See Complainant’s Response to
Request for Written Submissions
Regarding Issues Under Review;
Respondents’ Response to Request for
Written Submissions Regarding Issues
Under Review. On January 12, 2018, the
parties filed reply submissions. See
Complainant’s Reply to Respondents’
Submission Addressing the
Commission’s December 22, 2017
Notice; Respondents’ Reply to
Complainant’s Submission Regarding
Issues Under Review.
Having examined the record of this
investigation, including the final ID, and
the parties’ submissions, for the ’319
patent the Commission has determined
to (1) affirm the ALJ’s finding that a
combination of prior art references
Doppelt, Jacobs, and Gilbert fail to
render the asserted claims obvious and
(2) affirm the ALJ’s finding that a
combination of prior art references
Matsuoka, Doppelt, and Eckel fail to
render the asserted claims obvious, but
reverse the ALJ’s finding that Eckel is
analogous art. For the ’336 patent the
Commission has determined to (1)
affirm the ALJ’s finding that Pruessel,
either alone or in combination with
Koestler, fails to render claim 34
obvious and (2) take no position on the
ALJ’s finding that claim 34 recites
ineligible patent subject matter under 35
U.S.C. 101. The Commission adopts the
ID’s findings to the extent they are not
inconsistent with the Commission
opinion issued herewith.
Having found a violation of section
337 in this investigation, the
Commission has determined that the
appropriate form of relief is: (1) A
limited exclusion order prohibiting the
unlicensed entry of access control
systems and components thereof that
infringe one or more of claims 1–4, 7–
12, 15, and 16 of the ’319 patent that are
manufactured by, or on behalf of, or are
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imported by or on behalf of
Respondents or any of their affiliated
companies, parents, subsidiaries, agents,
or other related business entities, or
their successors or assigns, are excluded
from entry for consumption into the
United States, entry for consumption
from a foreign-trade zone, or withdrawal
from a warehouse for consumption, for
the remaining term of the ’319 patent
except under license of the patent
owner or as provided by law; and (2)
cease and desist orders prohibiting TTi
HK, TTi NA, One World, and OWT from
conducting any of the following
activities in the United States:
Importing, selling, marketing,
advertising, distributing, transferring
(except for exportation), and soliciting
U.S. agents or distributors for, access
control systems and components thereof
covered by one or more of claims 1–4,
7–12, 15, and 16 of the ’319 patent.
The Commission has also determined
that the public interest factors
enumerated in section 337(d) and (f) (19
U.S.C. 1337(d) and (f)) do not preclude
issuance of the limited exclusion order
or cease and desist orders. Finally, the
Commission has determined that a bond
in the amount of zero is required to
permit temporary importation during
the period of Presidential review (19
U.S.C. 1337(j)) of access control system
and components thereof that are subject
to the remedial orders. The
Commission’s orders and opinion were
delivered to the President and to the
United States Trade Representative on
the day of their issuance.
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 23, 2018.
Katherine Hiner,
Supervisory Attorney.
[FR Doc. 2018–06293 Filed 3–28–18; 8:45 am]
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA–392]
Bulk Manufacturer of Controlled
Substances Application: Chattem
Chemicals, Inc.
ACTION:
Notice; Correction.
The Drug Enforcement
Administration (DEA) published a
SUMMARY:
PO 00000
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Fmt 4703
Sfmt 4703
document in the Federal Register on
February 6, 2018, concerning a notice of
application that inadvertently did not
include the controlled substance
levorphanol (9220).
Correction
In the Federal Register on February 6,
2018, in FR Doc No: 2018–02343 (83 FR
5274), correct the table to include the
following basic class of controlled
substance:
Controlled
substance
Levorphanol ............
Drug code
9220
Schedule
II
Dated: March 15, 2018.
Susan A. Gibson,
Deputy Assistant Administrator.
[FR Doc. 2018–06327 Filed 3–28–18; 8:45 am]
BILLING CODE 4410–09–P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA–392]
Importer of Controlled Substances
Application: Fisher Clinical Services,
Inc.
ACTION:
Notice of application.
Registered bulk manufacturers of
the affected basic classes and applicants
therefore, may file written comments on
or objections to the issuance of the
proposed registration on or before April
30, 2018. Such persons may also file a
written request for a hearing on the
application on or before April 30, 2018.
ADDRESSES: Written comments should
be sent to: Drug Enforcement
Administration, Attention: DEA Federal
Register Representative/DRW, 8701
Morrissette Drive, Springfield, Virginia
22152. All requests for hearing must be
sent to: Drug Enforcement
Administration, Attn: Administrator,
8701 Morrissette Drive, Springfield,
Virginia 22152. All requests for hearing
should also be sent to: (1) Drug
Enforcement Administration, Attn:
Hearing Clerk/LJ, 8701 Morrissette
Drive, Springfield, Virginia 22152; and
(2) Drug Enforcement Administration,
Attn: DEA Federal Register
Representative/DRW, 8701 Morrissette
Drive, Springfield, Virginia 22152.
SUPPLEMENTARY INFORMATION:
The Attorney General has delegated
his authority under the Controlled
Substances Act to the Administrator of
the Drug Enforcement Administration
(DEA), 28 CFR 0.100(b). Authority to
exercise all necessary functions with
DATES:
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Federal Register / Vol. 83, No. 61 / Thursday, March 29, 2018 / Notices
respect to the promulgation and
implementation of 21 CFR part 1301,
incident to the registration of
manufacturers, distributors, dispensers,
importers, and exporters of controlled
substances (other than final orders in
connection with suspension, denial, or
revocation of registration) has been
redelegated to the Assistant
Administrator of the DEA Diversion
Control Division (‘‘Assistant
Administrator’’) pursuant to section 7 of
28 CFR part 0, appendix to subpart R.
In accordance with 21 CFR
1301.34(a), this is notice that on June 5,
2017, Fisher Clinical Services, Inc., 700
A–C Nestle Way, Breinigsville,
Pennsylvania 18031–1522 applied to be
registered as an importer of the
following basic classes of controlled
substances:
Controlled
substance
Methylphenidate .....
Levorphanol ............
Noroxymorphone ....
Tapentadol ..............
Drug code
1724
9220
9668
9780
Schedule
II
II
II
II
The company plans to import the
listed controlled substances in finished
dosage form for testing, and clinical
trials purposes only. This authorization
does not extend to the import of a
finished Food and Drug Administration
(FDA) approved or non-approved
dosage form for commercial distribution
in the United States.
Dated: March 15, 2018.
Susan A. Gibson,
Deputy Assistant Administrator.
[FR Doc. 2018–06321 Filed 3–28–18; 8:45 am]
BILLING CODE 4410–09–P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA–392]
Dated: March 15, 2018.
Susan A. Gibson,
Deputy Assistant Administrator.
Importer of Controlled Substances
Application: Lannett Company, Inc.
ACTION:
22152. All requests for hearing must be
sent to: Drug Enforcement
Administration, Attn: Administrator,
8701 Morrissette Drive, Springfield,
Virginia 22152. All requests for hearing
should also be sent to: (1) Drug
Enforcement Administration, Attn:
Hearing Clerk/LJ, 8701 Morrissette
Drive, Springfield, Virginia 22152; and
(2) Drug Enforcement Administration,
Attn: DEA Federal Register
Representative/DRW, 8701 Morrissette
Drive, Springfield, Virginia 22152.
SUPPLEMENTARY INFORMATION: The
Attorney General has delegated his
authority under the Controlled
Substances Act to the Administrator of
the Drug Enforcement Administration
(DEA), 28 CFR 0.100(b). Authority to
exercise all necessary functions with
respect to the promulgation and
implementation of 21 CFR part 1301,
incident to the registration of
manufacturers, distributors, dispensers,
importers, and exporters of controlled
substances (other than final orders in
connection with suspension, denial, or
revocation of registration) has been
redelegated to the Assistant
Administrator of the DEA Diversion
Control Division (‘‘Assistant
Administrator’’) pursuant to section 7 of
28 CFR part 0, appendix to subpart R.
In accordance with 21 CFR
1301.34(a), this is notice that on
February 24, 2014, Lannett Company,
Inc., 9001 Torresdale Avenue,
Philadelphia, Pennsylvania 19136
applied to be registered as an importer
of tetrahydrocannabinols (7370), a basic
class of controlled substance listed in
schedule I.
The company plans to import the
finished dosage forms to support their
abbreviated new drug application
(ANDA) submission to the U.S. Food
and Drug Administration (FDA). No
other activity for this drug code is
authorized for this registration.
[FR Doc. 2018–06313 Filed 3–28–18; 8:45 am]
Notice of application.
BILLING CODE 4410–09–P
Registered bulk manufacturers of
the affected basic classes and applicants
therefore, may file written comments on
or objections to the issuance of the
proposed registration on or before April
30, 2018. Such persons may also file a
written request for a hearing on the
application on or before April 30, 2018.
ADDRESSES: Written comments should
be sent to: Drug Enforcement
Administration, Attention: DEA Federal
Register Representative/DRW, 8701
Morrissette Drive, Springfield, Virginia
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DATES:
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA–392]
Importer of Controlled Substances
Application: Novitium Pharma, LLC
ACTION:
Notice of application.
Registered bulk manufacturers of
the affected basic classes, and
DATES:
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Sfmt 9990
applicants therefore, may file written
comments on or objections to the
issuance of the proposed registration on
or before April 30, 2018. Such persons
may also file a written request for a
hearing on the application on or before
April 30, 2018.
Written comments should
be sent to: Drug Enforcement
Administration, Attention: DEA Federal
Register Representative/DRW, 8701
Morrissette Drive, Springfield, Virginia
22152. All requests for hearing must be
sent to: Drug Enforcement
Administration, Attn: Administrator,
8701 Morrissette Drive, Springfield,
Virginia 22152. All request for hearing
should also be sent to: (1) Drug
Enforcement Administration, Attn:
Hearing Clerk/LJ, 8701 Morrissette
Drive, Springfield, Virginia 22152; and
(2) Drug Enforcement Administration,
Attn: DEA Federal Register
Representative/DRW, 8701 Morrissette
Drive, Springfield, Virginia 22152.
ADDRESSES:
SUPPLEMENTARY INFORMATION:
The Attorney General has delegated
his authority under the Controlled
Substances Act to the Administrator of
the Drug Enforcement Administration
(DEA), 28 CFR 0.100(b). Authority to
exercise all necessary functions with
respect to the promulgation and
implementation of 21 CFR part 1301,
incident to the registration of
manufacturers, distributors, dispensers,
importers, and exporters of controlled
substances (other than final orders in
connection with suspension, denial, or
revocation of registration) has been
redelegated to the Assistant
Administrator of the DEA Diversion
Control Division (‘‘Assistant
Administrator’’) pursuant to section 7 of
28 CFR part 0, appendix to subpart R.
In accordance with 21 CFR
1301.34(a), this is notice that on January
8, 2018, Novitium Pharma, LLC., 70
Lake Drive, East Windsor, NJ 08520
applied to be registered as an importer
of the Schedule II controlled substance
Levorphanol (9220).
The company plans to import the
controlled substance to develop the
manufacturing process for a drug
product that will in turn be used to
produce a tablet equivalent to the
current brand product.
Dated: March 15, 2018.
Susan A. Gibson,
Deputy Assistant Administrator.
[FR Doc. 2018–06318 Filed 3–28–18; 8:45 am]
BILLING CODE 4410–09–P
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[Federal Register Volume 83, Number 61 (Thursday, March 29, 2018)]
[Notices]
[Pages 13519-13520]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-06321]
-----------------------------------------------------------------------
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA-392]
Importer of Controlled Substances Application: Fisher Clinical
Services, Inc.
ACTION: Notice of application.
-----------------------------------------------------------------------
DATES: Registered bulk manufacturers of the affected basic classes and
applicants therefore, may file written comments on or objections to the
issuance of the proposed registration on or before April 30, 2018. Such
persons may also file a written request for a hearing on the
application on or before April 30, 2018.
ADDRESSES: Written comments should be sent to: Drug Enforcement
Administration, Attention: DEA Federal Register Representative/DRW,
8701 Morrissette Drive, Springfield, Virginia 22152. All requests for
hearing must be sent to: Drug Enforcement Administration, Attn:
Administrator, 8701 Morrissette Drive, Springfield, Virginia 22152. All
requests for hearing should also be sent to: (1) Drug Enforcement
Administration, Attn: Hearing Clerk/LJ, 8701 Morrissette Drive,
Springfield, Virginia 22152; and (2) Drug Enforcement Administration,
Attn: DEA Federal Register Representative/DRW, 8701 Morrissette Drive,
Springfield, Virginia 22152.
SUPPLEMENTARY INFORMATION:
The Attorney General has delegated his authority under the
Controlled Substances Act to the Administrator of the Drug Enforcement
Administration (DEA), 28 CFR 0.100(b). Authority to exercise all
necessary functions with
[[Page 13520]]
respect to the promulgation and implementation of 21 CFR part 1301,
incident to the registration of manufacturers, distributors,
dispensers, importers, and exporters of controlled substances (other
than final orders in connection with suspension, denial, or revocation
of registration) has been redelegated to the Assistant Administrator of
the DEA Diversion Control Division (``Assistant Administrator'')
pursuant to section 7 of 28 CFR part 0, appendix to subpart R.
In accordance with 21 CFR 1301.34(a), this is notice that on June
5, 2017, Fisher Clinical Services, Inc., 700 A-C Nestle Way,
Breinigsville, Pennsylvania 18031-1522 applied to be registered as an
importer of the following basic classes of controlled substances:
------------------------------------------------------------------------
Controlled substance Drug code Schedule
------------------------------------------------------------------------
Methylphenidate...................... 1724 II
Levorphanol.......................... 9220 II
Noroxymorphone....................... 9668 II
Tapentadol........................... 9780 II
------------------------------------------------------------------------
The company plans to import the listed controlled substances in
finished dosage form for testing, and clinical trials purposes only.
This authorization does not extend to the import of a finished Food and
Drug Administration (FDA) approved or non-approved dosage form for
commercial distribution in the United States.
Dated: March 15, 2018.
Susan A. Gibson,
Deputy Assistant Administrator.
[FR Doc. 2018-06321 Filed 3-28-18; 8:45 am]
BILLING CODE 4410-09-P
